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## Protocol Section ### Identification Module **NCT ID:** NCT05757479 **Brief Title:** Steroid-Eluting Stent Implant for the Treatment of Radiation-Related Sinusitis **Official Title:** Efficacy and Safety of Saline Rinses Combined With Steroid-Eluting Stent Implant or Steroid Nasal Spray in Radiation-Related Sinusitis #### Organization Study ID Info **ID:** SYSUCC-CMY-2022-sinusitis #### Organization **Class:** OTHER **Full Name:** Sun Yat-sen University ### Status Module #### Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-03-07 **Type:** ACTUAL **Last Update Submit Date:** 2023-03-03 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2023-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-02-11 **Type:** ACTUAL **Status Verified Date:** 2023-03 #### Study First Post Date **Date:** 2023-03-07 **Type:** ACTUAL **Study First Submit Date:** 2023-02-13 **Study First Submit QC Date:** 2023-03-03 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Zhongshan People's Hospital, Guangdong, China **Class:** OTHER **Name:** Fifth Affiliated Hospital of Guangzhou Medical University #### Lead Sponsor **Class:** OTHER **Name:** Sun Yat-sen University #### Responsible Party **Investigator Affiliation:** Sun Yat-sen University **Investigator Full Name:** Ming-Yuan Chen **Investigator Title:** professor & chief physician **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Sinusitis is one of the most common sequelae after radiotherapy among nasopharyngeal carcinoma patients. While local steroids have been shown to be effective in the management of patients with chronic rhinosinusitis, their role in treating radiation-related sinusitis is ambiguous. Poor adherence to nasal steroid spray often contributes to the failure of symptom relief. The aim of this study is to determine if steroids stents implantation into the sinuses could improve patient outcomes in radiation-related sinusitis. **Detailed Description:** Investigators aim to assess the efficacy and safety of Steroid-eluting stents when implanted in sinus in patients with radiation-related sinusitis. This phase III randomized controlled study enrolled nasopharyngeal carcinoma patients who received radiotherapy and developed severe radiation-related sinusitis. Subjects were randomly assigned to receive steroid-eluting stents implantation or nasal steroid spray. All study patients also received saline rinses. ### Conditions Module **Conditions:** - Radiation-Induced Mucositis **Keywords:** - Nasopharyngeal carcinoma - Radiation-related sinusitis - Steroid-eluting stent ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 168 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects randomized to the experimental group will receive steroid-eluting stent implantation in the affected sinus and saline rinses. **Intervention Names:** - Procedure: Steroid-eluting stent implantation - Procedure: nasal saline rinses **Label:** Steroid-eluting stent implant **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Subjects randomized to the comparator group will receive nasal steroid spray and saline rinses. **Intervention Names:** - Drug: Steroid nasal spray - Procedure: nasal saline rinses **Label:** Nasal steroid spray **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Steroid-eluting stent implant **Description:** The sinus cavity with inflammation receives one bioabsorbable steroid-eluting sinus stent. **Name:** Steroid-eluting stent implantation **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Nasal steroid spray **Description:** 1 spray into each nostril once a day. **Name:** Steroid nasal spray **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Nasal steroid spray - Steroid-eluting stent implant **Description:** The saltwater runs through nasal passages and drains out of the nostril. **Name:** nasal saline rinses **Other Names:** - Nasal irrigation **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The change in Sino-Nasal Outcome Test scores (SNOT-22) scores pre- and post-treatment between the two arms was measured. The Sino-Nasal Outcome Test asks subjects to rate how "bad" their rhinosinusitis is by using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The SNOT includes 22 questions (symptoms and social/emotional consequences of rhinosinusitis), each of which are rated from 0 to 5 for a minimum score of 0 to maximum score of 110, with higher scores representing worse outcome. **Measure:** Change in Sino-Nasal Outcome Test Scores (SNOT-22) **Time Frame:** Change from Baseline to Week 12 **Description:** Sinus MRI Lund-Mackay (LM) score (0-20). Higher score means more severe disease. **Measure:** Change in Lund-Mackay MRI score **Time Frame:** Change from Baseline to Week 12 #### Secondary Outcomes **Description:** The Lund Kennedy scoring system for nasal endoscopy rates the severity of the sinusitis based on the endoscopic appearance of the nasal mucosa. Edema, secretions and the presence of polyps are rated from 0-2, for a total maximum score of 6 per each side of the nose. Higher scores represent more severe disease. **Measure:** Lund-Kennedy Scoring for Nasal Endoscopy **Time Frame:** Change from Baseline to Week 12 and Week 24 **Description:** The change in Sino-Nasal Outcome Test scores (SNOT-22) scores pre- and post-treatment between the two arms was measured. The Sino-Nasal Outcome Test asks subjects to rate how "bad" their rhinosinusitis is by using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The SNOT includes 22 questions (symptoms and social/emotional consequences of rhinosinusitis), each of which are rated from 0 to 5 for a minimum score of 0 to maximum score of 110, with higher scores representing worse outcome. **Measure:** Change in Sino-Nasal Outcome Test Scores (SNOT-22) **Time Frame:** Change from Baseline to Week 4 and Week 24 **Description:** Comparison of quality of life using questionnaires EORTC QLQ-30. All EORTC QLQ-C30 scale scores range from 0 to 100. A high score for a functional scale represents a high level of functioning, whereas a high score for a symptom scale/single item represents a high level of symptom-atology. **Measure:** Change in Quality of life using The European Organization for Research and Treatment of Cancer core quality of life questionnaire（EORTC QLQ-30） **Time Frame:** Change from Baseline to Week 12 and Week 24 **Description:** Comparison of quality of life using questionnaires HN35. HN35 score ranges from zero to 100. A high score for a functional or global scale represents a relatively high/healthy level of functioning or global quality of life, whereas a high score for a symptom scale represents the presence of a symptom or problem(s). **Measure:** Change in Quality of life using questionnaires EORTC QLQ-Head&Neck35 (HN35) **Time Frame:** Change from Baseline to Week 12 and Week 24 **Description:** Rescue medication use of corticosteroids and antibiotics. Specifically, total usage over six month period. **Measure:** Rescue medication **Time Frame:** Week 12 and Week 24 **Description:** Cure: the symptoms disappeared, sinus ostium open, and the sinus mucosa was epithelialized without purulent secretions. Improved: the symptoms were significantly improved. Endoscopic examination showed edema, hypertrophy or granulation tissue formation in some areas of sinus mucosa, and a small amount of purulent secretions. Ineffective: the symptoms were not improved. Endoscopic examination showed stenosis or atresia of the sinus ostium, formation of polyps or purulent secretions. **Measure:** The effective rate **Time Frame:** Week 12 and Week 24 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * pathologically confirmed nasopharyngeal carcinoma patients * finished radical radiotherapy (≥66Gy) for at least 3 months * tumor complete response * received appropriate medical treatment for sinusitis during or after radiotherapy * confirmed sinusitis according to European Position Paper on Rhinosinusitis and Nasal Polyps 2020 * SNOT-22 ≥ 20 and MRI Lund-Mackay score \> 8 * 18-70 years old Exclusion Criteria: * anatomic variation resulted in occluded ostiomeatal complex * Karnofsky score ≤ 70 * life-threatening medical conditions * tumour residue or recurrence * acute bacterial sinusitis or acute fungal sinusitis * cystic fibrosis or primary ciliary dyskinesia * dependence on prolonged corticosteroid therapy for comorbid conditions * history of allergy to topical steroids * pregnant or breastfeeding **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ming-Yuan Chen, MD, PhD **Phone:** 86-20-8734-3361 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Si-Yuan Chen, MD **Phone:** 86-18711150216 **Role:** CONTACT #### Locations **Location 1:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ming-Yuan Chen, MD,PhD - **Phone:** 86-20-8734-2422 - **Role:** CONTACT **Country:** China **Facility:** Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center **State:** Guangdong **Status:** RECRUITING **Zip:** 510060 #### Overall Officials **Official 1:** **Affiliation:** Sun Yat-sen University **Name:** Ming-Yuan Chen, MD, PhD **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005759 - Term: Gastroenteritis - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000010254 - Term: Paranasal Sinus Diseases - ID: D000009668 - Term: Nose Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000010038 - Term: Otorhinolaryngologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M1730 - Name: Nasopharyngeal Carcinoma - Relevance: LOW - As Found: Unknown - ID: M26955 - Name: Mucositis - Relevance: HIGH - As Found: Mucositis - ID: M15657 - Name: Sinusitis - Relevance: HIGH - As Found: Sinusitis - ID: M8875 - Name: Gastroenteritis - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M13167 - Name: Paranasal Sinus Diseases - Relevance: LOW - As Found: Unknown - ID: M12604 - Name: Nose Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M12961 - Name: Otorhinolaryngologic Diseases - Relevance: LOW - As Found: Unknown - ID: T4047 - Name: Nasopharyngeal Carcinoma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012852 - Term: Sinusitis - ID: D000052016 - Term: Mucositis ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00799279 **Brief Title:** Integrating Smoking Cessation Into Routine Primary Care Practice **Official Title:** Comparative Evaluation of the Efficacy and Cost-effectiveness of Two Interventions for Integrating Smoking Cessation Into Routine Primary Care Practice: A Cluster-randomized Trial #### Organization Study ID Info **ID:** 15053 #### Organization **Class:** OTHER **Full Name:** University of Waterloo #### Secondary ID Infos **Domain:** Canadian Tobacco Control Research Initiative **ID:** CTCRI 019826 **Type:** OTHER_GRANT **Domain:** Canadian Tobacco Control Research Initiative **ID:** CTCRI 19813 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2010-09 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2010-10-06 **Type:** ESTIMATED **Last Update Submit Date:** 2010-10-05 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2010-04 **Type:** ACTUAL #### Start Date **Date:** 2009-01 **Status Verified Date:** 2010-10 #### Study First Post Date **Date:** 2008-11-27 **Type:** ESTIMATED **Study First Submit Date:** 2008-11-17 **Study First Submit QC Date:** 2008-11-26 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Ottawa Heart Institute Research Corporation **Class:** OTHER **Name:** Canadian Tobacco Control Research Initiative #### Lead Sponsor **Class:** OTHER **Name:** University of Waterloo #### Responsible Party **Old Name Title:** Paul McDonald **Old Organization:** University of Waterloo ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of this study is to determine if providing smokers identified in family doctors offices with follow-up counselling enhances their success with quitting and the number of health professionals helping patients with quitting. Six to eight family medicine clinics will be involved in the study. We will compare the frequency of addressing smoking with patients and the proportion of smokers who are successful with quitting 16-weeks following the clinic appointment between practices. It is hypothesized that the addition of follow-up counseling to a multi-component smoking cessation intervention will improve smoking outcomes. **Detailed Description:** A family doctor's advice to quit has been shown to increase a smoker's motivation to quit. Despite the evidence supporting the importance of smoking cessation, there is a well-documented practice gap in the rates at which smoking cessation is being addressed by practitioners. The primary objectives of this research study are to determine whether adjunct telephone-based smoking cessation follow-up counselling when delivered as part of a multi-component intervention: 1. Increases the rate at which evidence-based smoking cessation interventions are delivered to smokers identified in family doctors offices, compared to providing only practice supports. 2. Increases smoking abstinence as measured three months after the estimated target quit date (i.e.16 weeks) compared to providing only practice supports. 3. Is more cost-effective (cost/quit) than providing only practice supports to family doctors offices. A two-arm before-after matched-pair cluster randomized trial, will test the effectiveness of two strategies for integrating smoking cessation treatments into primary care practice routines and enhancing cessation. Six to eight family doctors offices will be randomized to either a practice support (PS) group, or a follow-up counseling (FC) group. From each of the intervention practices a cross-sectional sample of 50 eligible smokers will be recruited pre- and post-intervention to assess 5A's delivery and smoking abstinence. ### Conditions Module **Conditions:** - Smoking Cessation **Keywords:** - smoking - cessation - family medicine - evidence-based - knowledge translation - smoking cessation, primary care ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 835 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** smoking cessation training for providers,practice tools for providers, patient quit plan, and follow-up telephone counselling for smokers **Intervention Names:** - Behavioral: Smoking cessation training, support, and telephone follow-up **Label:** Follow-up Counseling Arm **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** smoking cessation training for providers,practice tools for providers, patient quit plan for smokers. **Intervention Names:** - Behavioral: smoking cessation intervention **Label:** Practice Support Arm **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Follow-up Counseling Arm **Description:** The CF group will receive the same smoking cessation training and practice support tools delivered to the PS group. In addition, patients in the FC group who are smokers and are willing to set a quit date within the next 30 days and who have set a quit date will be enrolled in an interactive voice response (IVR)-mediated telephone follow-up and counselling system. The IVR system will automatically contact patients via telephone 7 days before their TQD, and 5, 14, 30, and 60 days after their TQD to check the patients' smoking status, potential concerns, and their risk of relapse. **Name:** Smoking cessation training, support, and telephone follow-up **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Practice Support Arm **Description:** Intervention practices will be provided with training in smoking cessation, and will be supported with integrating a waiting room screener for smoking and smoking consult form and patient quit plan into their practice routines. **Name:** smoking cessation intervention **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Self-report and biochemically validated point prevelence smoking abstinence **Measure:** smoking abstinence **Time Frame:** 16-weeks #### Secondary Outcomes **Measure:** cost-effectiveness **Time Frame:** 16-weeks **Description:** Rates of providers, asking, advising, assessing, assisting, and arranging were assessed **Measure:** Rate of provider delivery of evidence-based smoking treatments **Time Frame:** exit survey on day of clinic visits ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Practices will be eligible for participation in the present study if they meet the following criteria: 1. Practice is a family health team (FHT), family health group (FHG); or family health network (FHN); 2. All physicians within the practice are willing to participate in the study; 3. Practice will see an average of 50 patients per day and 10% of patients are smokers; 4. Practice is willing to provide consent to contact patients in waiting rooms and survey patients during office hours and by telephone. * Patients will be eligible to participate in the study if they meet the following criteria: 1. Patient is seen in clinic for annual exam or non-urgent visit; 2. Patient is a current smoker (\>1 cigarette per day on most days of the week); 3. Patient is 18 years of age or older; 4. Patient is able to read and understand English or French; 5. Patient has a home or mobile telephone which can be used to receive follow-up telephone counselling calls Exclusion Criteria: * Patients who do not have the mental capacity to provide informed consent and complete study protocols will be excluded. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** University of Waterloo **Name:** Paul McDonald, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02872779 **Acronym:** COCA-MACS **Brief Title:** Correlation Between Circulating Tumour Markers Early Variations and Clinical Response in First Line Treatment of Metastatic Colorectal Cancer **Official Title:** Correlation Between Circulating Tumour Markers Early Variations and Clinical Response in First Line Treatment of Metastatic Colorectal Cancer #### Organization Study ID Info **ID:** 2015/076/HP #### Organization **Class:** OTHER **Full Name:** University Hospital, Rouen ### Status Module #### Completion Date **Date:** 2020-08 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2017-08-22 **Type:** ACTUAL **Last Update Submit Date:** 2017-08-21 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2020-08 **Type:** ESTIMATED #### Start Date **Date:** 2016-08 **Status Verified Date:** 2017-08 #### Study First Post Date **Date:** 2016-08-19 **Type:** ESTIMATED **Study First Submit Date:** 2016-08-16 **Study First Submit QC Date:** 2016-08-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Rouen #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The chemotherapy monitoring is currently based on radiological (RECIST 1.1 guideline) and clinical evaluation every 3 months. Circulating markers as Carcino Embryonic Antigen (CEA), circulating tumour DNA and total cell free DNA represent an alternative approach to evaluate the response. In the field of metastatic colorectal cancer (mCRC) recent studies suggest that early evaluation could be clinically relevant. Indeed, early tumoral response seems to be correlated to overall survival. Moreover, post-operative morbidity increases with the number of prior chemotherapy treatments. Early evaluation could allow to modify chemotherapy regimens when response appears to be insufficient. The aim of the present study is to evaluate, in a prospective cohort of patients treated with systemic IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy as first line treatment for a mCRC, the correlation between early variations of circulating tumour markers including CEA, circulating tumour DNA and total cell free DNA, and the 3 months objective response as defined in the RECIST 1.1 guideline. ### Conditions Module **Conditions:** - Circulating Markers - Metastatic Colorectal Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 74 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Blood sampling for free mutant DNA analysis for Patients Treated for Metastatic Colorectal cancer **Intervention Names:** - Procedure: Blood sampling for free mutant DNA analysis **Label:** Patients Treated for Metastatic Colorectal cancer **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients Treated for Metastatic Colorectal cancer **Description:** Blood sampling for Patients Treated for Metastatic Colorectal cancer **Name:** Blood sampling for free mutant DNA analysis **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Variation of free mutant DNA kinetic at week 5 to predict tumor progression at 3 months (Evaluation based on the RECIST 1.1 guideline) **Measure:** Difference from baseline in the number of free mutant DNA in blood **Time Frame:** 5 weeks #### Secondary Outcomes **Description:** Variation of free mutant DNA kinetic at week 3 to predict tumor progression at 3 months (Evaluation based on the RECIST 1.1 guideline) **Measure:** Difference from baseline in the number of free mutant DNA in blood **Time Frame:** 3 weeks **Description:** sensitivity and specificity of free mutant DNA kinetic at Week 5 (RECIST) to predict tumor progression at 3 months (RECIST) **Measure:** Evaluation of response based on the RECIST 1.1 guideline **Time Frame:** 3 Months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or female, age superior to 18 years. * Histologically confirmed metastatic colorectal adenocarcinoma. * Measurable disease according to the RECIST 1.1 guideline * ECOG performance status \<3. * Disease requiring IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy (cetuximab or panitumumab or bevacizumab) every 14 days * No prior chemotherapy for this adenocarcinoma with the exception of adjuvant chemotherapy * Signed and dated informed consent document. Exclusion Criteria: * Medical history of cancer within 5 years * Medical contraindication for a treatment consisted of IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy (cetuximab or panitumumab or bevacizumab) * Patient with known psychiatric or substance abuse disorders that could interfere with cooperation with the requirements of the study **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Alice GANGLOFF, MD **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Julien BLOT **Role:** CONTACT #### Locations **Location 1:** **City:** Rouen **Contacts:** ***Contact 1:*** - **Name:** Pierre MICHEL, Pr - **Role:** SUB_INVESTIGATOR **Country:** France **Facility:** Rouen University Hospital **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Rouen University Hospital **Name:** Alice GANGLOFF, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007414 - Term: Intestinal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000012002 - Term: Rectal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M17890 - Name: Colorectal Neoplasms - Relevance: HIGH - As Found: Colorectal Cancer - ID: M10448 - Name: Intestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M14844 - Name: Rectal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015179 - Term: Colorectal Neoplasms ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00166179 **Brief Title:** Magnetic Resonance Imaging (MRI) Viability: Comparison of Myocardial Viability by Positron Emission Tomography and MRI **Official Title:** Magnetic Resonance Imaging (MRI) Viability: Comparison of Myocardial Viability by Positron Emission Tomography and MRI #### Organization Study ID Info **ID:** IRB00000292 #### Organization **Class:** OTHER **Full Name:** Emory University #### Secondary ID Infos **Domain:** Other **ID:** 6-56550 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2006-10 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2014-09-26 **Type:** ESTIMATED **Last Update Submit Date:** 2014-09-25 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2006-10 **Type:** ACTUAL #### Start Date **Date:** 2003-11 **Status Verified Date:** 2014-09 #### Study First Post Date **Date:** 2005-09-14 **Type:** ESTIMATED **Study First Submit Date:** 2005-09-13 **Study First Submit QC Date:** 2005-09-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Emory University #### Responsible Party **Investigator Affiliation:** Emory University **Investigator Full Name:** Randolph E Patterson **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to compare cardiac MRI with positron emission tomography (PET) with fluorodeoxyglucose (FDG) to determine if cardiac MRI images are as good as, or better, than PET with FDG. ### Conditions Module **Conditions:** - Coronary Artery Disease **Keywords:** - CAD ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 57 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Measure:** Magnetic Resonance Imaging (MRI) Viability: Comparison of Myocardial Viability by Positron Emission Tomography and MRI **Time Frame:** time of initial scans #### Secondary Outcomes **Measure:** Compare size of regions of viable and non viable myocardium as % left ventricle by MRI vs. PET **Time Frame:** at time of initial scans ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * PET-FDG ordered to assess myocardial viability Exclusion Criteria: * Contraindicated for MRI * Pregnant * Age \<25 yrs **Maximum Age:** 95 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Age \> 25 yrs, mean + SD = 60.3 + 10.2, 83% male, are patients referred by cardiologist or cardiac surgeon for assessment of myocardial viability by PET FDG. ### Contacts Locations Module #### Locations **Location 1:** **City:** Atlanta **Country:** United States **Facility:** Crawford Long Hospital **State:** Georgia **Zip:** 30308 #### Overall Officials **Official 1:** **Affiliation:** Staff **Name:** Randolph Patterson, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003327 - Term: Coronary Disease - ID: D000017202 - Term: Myocardial Ischemia - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000001161 - Term: Arteriosclerosis - ID: D000001157 - Term: Arterial Occlusive Diseases - ID: D000014652 - Term: Vascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M6549 - Name: Coronary Disease - Relevance: LOW - As Found: Unknown - ID: M6546 - Name: Coronary Artery Disease - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M4469 - Name: Arteriosclerosis - Relevance: LOW - As Found: Unknown - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003324 - Term: Coronary Artery Disease ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06296979 **Brief Title:** Effectiveness of Noninvasive Phrenic Nerve Neuromodulation in Shoulder Pain and Hepatobiliary Visceral Comorbidity. **Official Title:** Effectiveness of Noninvasive Phrenic Nerve Neuromodulation in Subjects With Right Shoulder Pain and Hepatobiliary Visceral Comorbidity. #### Organization Study ID Info **ID:** 0881-N-23 #### Organization **Class:** OTHER **Full Name:** University of Seville ### Status Module #### Completion Date **Date:** 2026-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-04-15 **Type:** ACTUAL **Last Update Submit Date:** 2024-04-12 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-20 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-03-06 **Type:** ACTUAL **Study First Submit Date:** 2024-02-23 **Study First Submit QC Date:** 2024-03-05 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Seville #### Responsible Party **Investigator Affiliation:** University of Seville **Investigator Full Name:** Angel Oliva Pascual-Vaca **Investigator Title:** Doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Pain, particularly shoulder pain, is a social and economic problem worldwide. Although visceral pathology is not yet taken into account in the diagnosis of these pains, it is likely that on numerous occasions the hepatobiliary visceral condition causes referred pain in the metameric area belonging to the shoulder due to the involvement of the phrenic nerve. Therefore, the aim of this project is to study the response of treatment by neuromodulation of the phrenic nerve for shoulder pain in patients with associated hepatobiliary pathologies, assessing the possible visceral involvement in the symptomatology. **Detailed Description:** Approximately 80% of patients with liver disease suffer chronic pain and fatigue, which can lead to sensitization of the central and peripheral nervous system. Central sensitization is an increase in the responsiveness of neurons within the central nervous system, which can lead to generalized pain hypersensitivity. It has been shown that some lesions or inflammatory processes can trigger changes in the nervous system, generating persistent pain. According to the theory of visceral referred pain, there are visceral and musculoskeletal stimuli that converge in higher centers capable of producing referred pain in regions where metameric innervation is shared. This raises the possibility that altered visceral mechanisms may provoke and chronify musculoskeletal pain. According to this theory, people with structural or functional hepatobiliary pathologies may have referred pain in the right metameric territory of C2-C3-C4-C5, which may generate pain in the shoulder on the same side. This is due to the fact that the phrenic nerve sensitively innervates Glisson's capsule, so any affectation of this structure can generate afferent stimuli to the previously mentioned metameric levels. The phrenic hypothesis plays a very important role today, having as its main "endorsement" the analgesic techniques of phrenic blockade used for shoulder pain after hepatectomy. In order to eliminate this post-operative shoulder pain, electrical or medical nerve blocks are used. ### Conditions Module **Conditions:** - Shoulder Pain **Keywords:** - phrenic nerve - Shoulder Pain - Nuromodulation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 34 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** the usual treatment of the center consisting of manual therapy, exercise and thermotherapy will be performed. **Intervention Names:** - Procedure: common Physical therapy **Label:** USUAL PHYSIOTHERAPY **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** The intervention group will receive the usual physiotherapy treatment at the health center and will also receive neuromodulation on the phrenic nerve at its exit through the anterior cervical region. The neuromodulation technique will be applied for 10 minutes. **Intervention Names:** - Device: Phrenic nerve neuromodulation - Procedure: common Physical therapy **Label:** Transcutaneous electrical nerve stimulation **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Transcutaneous electrical nerve stimulation **Description:** The intervention group will receive the usual physiotherapy treatment at the health center and will also receive neuromodulation on the phrenic nerve at its exit through the anterior cervical region. The neuromodulation technique will be applied for 10 minutes. **Name:** Phrenic nerve neuromodulation **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Transcutaneous electrical nerve stimulation - USUAL PHYSIOTHERAPY **Description:** the usual treatment of the center consisting of manual therapy, exercise and thermotherapy will be performed. **Name:** common Physical therapy **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Perceived pain. Self-perceived pain intensity will be evaluated by a 0 to 10 Numeric Pain Rating Scale (NPRS), where 0 denotes no pain and 10 denotes the maximum possible pain. **Measure:** Numeric Pain Rating Scale **Time Frame:** pre-treatment, 1 week, 4 week, 12 week. #### Secondary Outcomes **Description:** Pain threshold to pressure at specific tender points of the shoulder: infraspinatus, deltoid and trapezius. PPT levels defined as the minimum pressure required to evoke pain will be assessed using a portable electronic pressure algometer. Change from baseline on algometry. The units of measurement of pressure pain will be Kg/cm2. **Measure:** Algometry **Time Frame:** pre-treatment, 1 week, 4 week, 12 week. **Description:** measurement of passive pain-free ranges of motion of flexion, internal rotation, external rotation and abduction of the right shoulder with a portable goniometer. the unit of measurement shall be the degree of movement. **Measure:** Goniometry passive **Time Frame:** pre-treatment, 1 week, 4 week, 12 week. **Description:** Questionnaire that measures the function of the upper limb. It is composed of 11 items that are rated from 1 to 5, from least to most difficult to perform certain movements. **Measure:** Quick Dash questionnaire **Time Frame:** pre-treatment, 1 week, 4 week, 12 week. **Description:** measurement of active pain-free ranges of motion of flexion, internal rotation, external rotation and abduction of the right shoulder with a portable goniometer. the unit of measurement shall be the degree of movement. **Measure:** Goniometriy active **Time Frame:** pre-treatment, 1 week, 4 week, 12 week. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Over 18 years of age and under 64 years of age. * Subjects presenting right shoulder pain at the time of enrollment in the study. * Presentation of a hepatobiliary visceral disorder that may justify the visceral etiology of the pain. * That they agree to participate in the project by signing the informed consent form. Exclusion Criteria: * Patients with chronic pain due to other diseases such as malignant disease. * Patients with rheumatic diseases. * Cutaneous infection in the area of pain. * Disease of neurological, traumatic, oncologic, or infectious origin that rules out the visceral origin of the pain. * Uncooperative subject. * Severe psychiatric disease. * Loss of cognitive capacity. * Contraindication to electrotherapy. **Maximum Age:** 64 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Adolfo Rosado Portillo **Phone:** 605663879 **Role:** CONTACT #### Locations **Location 1:** **City:** Sevilla **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Deseada López Carballo, Dra - **Role:** CONTACT **Country:** Spain **Facility:** Centro de Salud Ronda Histórica **Status:** RECRUITING **Zip:** 41008 **Location 2:** **City:** Sevilla **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Alicia Valero Sáinz - **Phone:** 649532242 - **Phone Ext:** +34 - **Role:** CONTACT **Country:** Spain **Facility:** Centro de Salud las Letanías **Status:** RECRUITING **Zip:** 41013 **Location 3:** **City:** Sevilla **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** María Isabel Morilla Párraga - **Phone:** 609582376 - **Phone Ext:** +34 - **Role:** CONTACT **Country:** Spain **Facility:** Centro de Salud Bellavista **Status:** RECRUITING **Zip:** 41014 #### Overall Officials **Official 1:** **Affiliation:** University of Seville **Name:** Ángel Oliva Pascual-Vaca, Dr **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000018771 - Term: Arthralgia - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M21907 - Name: Shoulder Pain - Relevance: HIGH - As Found: Shoulder Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M20833 - Name: Arthralgia - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000020069 - Term: Shoulder Pain ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00222079 **Brief Title:** Evaluation of Esomeprazole in Treating Gastro-esophageal Reflux Disease (GERD) in Head and Neck Cancer Patients Exposed to Radiation Therapy **Official Title:** Pilot Study to Evaluate Esomeprazole (Nexium) in Treating Gastro-esophageal Reflux in Patients With Head and Neck Cancer With Prior External Beam Radiation Therapy: a Randomized, Prospective, Placebo-controlled, Double-blind Study. #### Organization Study ID Info **ID:** 200308067 #### Organization **Class:** OTHER **Full Name:** University of Iowa ### Status Module #### Completion Date **Date:** 2008-02 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-12-14 **Type:** ACTUAL **Last Update Submit Date:** 2017-12-12 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2007-10 **Type:** ACTUAL #### Start Date **Date:** 2004-11 **Type:** ACTUAL **Status Verified Date:** 2017-12 #### Study First Post Date **Date:** 2005-09-22 **Type:** ESTIMATED **Study First Submit Date:** 2005-09-16 **Study First Submit QC Date:** 2005-09-16 **Why Stopped:** Project canceled due to the implementation of IMRT, fewer patients reporting xerostomia. ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Douglas Trask #### Responsible Party **Investigator Affiliation:** University of Iowa **Investigator Full Name:** Douglas Trask **Investigator Title:** Principal Investigator **Type:** SPONSOR_INVESTIGATOR ### Description Module **Brief Summary:** The purpose of this research study is to measure acid reflux into the throat both before and after medical treatment in people who have had radiation therapy to their head and neck for the treatment of cancer. Many people who have received head and neck radiation therapy develop a dry mouth as a result of the radiation damage to their saliva glands. In addition to the discomfort associated with a dry mouth, the decrease in saliva may increase the severity of gastro-esophageal reflux disease (acid reflux). Acid reflux occurs when acid escapes from your stomach into your throat. You may not have any symptoms of acid reflux, but often it can cause symptoms of heartburn or chest discomfort. Acid reflux can be treated once it is diagnosed. Treatment consists of dietary changes, behavioral alterations, and medication. Medications are available that decrease the amount of acid in your stomach. Diagnosis of acid reflux is made with a pH-probe to test for acid in your throat. **Detailed Description:** The annual incidence of squamous cell carcinoma of the head and neck (SCCHN) is 40,000 cases per year in the US and 60,000 cases per year in Europe. Radiation therapy is employed in combination with chemotherapy in primary treatment or as adjuvant therapy for over half of patients with SSCHN. A high incidence of pathologic laryngopharyngeal reflux and gastroesophageal reflux is observed in patients with head and neck cancer. When treatment for the cancer includes radiation therapy, an incidence of 90% has been reported \[2\]. Although the interplay between acid reflux and the development of head and neck cancer remains unclear, there is a strong argument that radiation therapy worsens the problem by muting the body's ability to neutralize acid. Radiation therapy is extensively used in the treatment of squamous cell carcinoma of the head and neck. Radiation therapy works by exploiting a survival differential between malignant cells and normal cells. Simply stated, the malignant cells are more likely to die with radiation when compared to normal non-malignant cells. However, not all normal cells respond equally and some normal tissues have marked sensitivity to radiation damage. Salivary glands are one such radiosensitive tissue that is permanently destroyed with external-beam radiotherapy. Damage to salivary tissues by radiation decreases their ability to excrete saliva. This is supported by Olmos et al, who used salivary scintigraphy on both irradiated and non-irradiated patients and found that 84% of those irradiated had total or partial disturbance in both baseline and stimulated function. Of those treated with greater than 4500cGy, salivary excretion was almost invariably impaired. Xerostomia is the term for the dry mouth, which can result from this loss. In addition to the volume of the saliva, the contents of the saliva are also important. Helm et al. "...evaluated the properties of human saliva relevant to its potential contribution to esophageal acid clearance." By measuring the capacity for acid neutralization and plotting titration curves, they identified that saliva and especially its bicarbonate content play an important role in neutralization of esophageal acid in both resting and lozenge-stimulated states. As saliva plays an active role in the neutralization of esophageal acid and its clearance from the esophagus, loss of saliva is predicted to increase the severity and incidence of reflux as the protective effect of saliva's ability to clear and neutralize acid reflux is diminished. Korsten et al., assessed the effects of chronic xerostomia on parameters of gastroesophageal reflux and esophagitis and reported markedly impaired clearance of acid from the esophagus and abnormal 24-hour intra-esophageal pH studies from a cohort of male patients with xerostomia. Medications are available to increase salivary flow but these are often minimally effective and poorly tolerated. Decreasing stomach acid production is an alternative method of mitigating the effect of GERD in these patients. Esomeprazole has been proven beneficial in the treatment of gastroesophageal reflux disease and is anticipated to be beneficial in treating SCCHN patients treated with external-beam radiation therapy. ### Conditions Module **Conditions:** - Gastro-esophageal Reflux ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** DOUBLE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** Esomeprazole (Nexium) **Type:** DRUG ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Signed informed consent 2. History of head and neck cancer 3. Radiation Therapy (external beam or IMRT) 1. Must have received equal or greater than 5000 cGy cumulative dose 2. Must have complaint of xerostomia 3. Greater than three month interval since radiation treatment Exclusion Criteria: 1. Subjects unable to tolerate pH-probe in past 2. Subjects currently on proton-pump inhibitor (PPI) or H-2 receptor antagonist therapy 3. Prior history of esophago-gastric surgery 4. Symptoms of gastrointestinal bleeding (melena, hematemesis) 5. Known hepatic cirrhosis or esophageal varices 6. Prior esophageal perforation 7. Pregnant, nursing or not likely to be using adequate contraceptive measures 8. Subjects not predicted to survive duration of study 9. Subjects with allergies or sensitivities to proton-pump inhibitors 10. Psychological, familial, sociological or geographical conditions which do not permit Study follow-up and compliance with study protocol 11. Subjects predicted to undergo surgery, chemotherapy or radiation therapy for head and neck cancer during the course of study **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Iowa City **Country:** United States **Facility:** University of Iowa Department of Otolaryngology **State:** Iowa **Zip:** 52242 #### Overall Officials **Official 1:** **Affiliation:** University of Iowa **Name:** Douglas K trask, MD. Ph.D. **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000015154 - Term: Esophageal Motility Disorders - ID: D000003680 - Term: Deglutition Disorders - ID: D000004935 - Term: Esophageal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000004941 - Term: Esophagitis - ID: D000005759 - Term: Gastroenteritis - ID: D000010437 - Term: Peptic Ulcer - ID: D000004378 - Term: Duodenal Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000013272 - Term: Stomach Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: HIGH - As Found: Head and Neck Cancer - ID: M8880 - Name: Gastroesophageal Reflux - Relevance: HIGH - As Found: Gastro Esophageal Reflux - ID: M8091 - Name: Esophagitis - Relevance: LOW - As Found: Unknown - ID: M8092 - Name: Esophagitis, Peptic - Relevance: HIGH - As Found: Gastro Esophageal Reflux - ID: M17874 - Name: Esophageal Motility Disorders - Relevance: LOW - As Found: Unknown - ID: M17875 - Name: Esophageal Spasm, Diffuse - Relevance: LOW - As Found: Unknown - ID: M6882 - Name: Deglutition Disorders - Relevance: LOW - As Found: Unknown - ID: M8085 - Name: Esophageal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8875 - Name: Gastroenteritis - Relevance: LOW - As Found: Unknown - ID: M17206 - Name: Ulcer - Relevance: LOW - As Found: Unknown - ID: M13348 - Name: Peptic Ulcer - Relevance: LOW - As Found: Unknown - ID: M7552 - Name: Duodenal Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M16062 - Name: Stomach Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000005764 - Term: Gastroesophageal Reflux - ID: D000004942 - Term: Esophagitis, Peptic ### Intervention Browse Module - Ancestors - ID: D000000897 - Term: Anti-Ulcer Agents - ID: D000005765 - Term: Gastrointestinal Agents - ID: D000054328 - Term: Proton Pump Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M30204 - Name: Esomeprazole - Relevance: HIGH - As Found: Risk of - ID: M4188 - Name: Antacids - Relevance: LOW - As Found: Unknown - ID: M4219 - Name: Anti-Ulcer Agents - Relevance: LOW - As Found: Unknown - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown - ID: M27630 - Name: Proton Pump Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000064098 - Term: Esomeprazole ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04918979 **Brief Title:** Information Extraction and Database Construction for Emergent Patients Based on Voice and Image Recognition Technology **Official Title:** Triage Information Extraction Technology Development and Database Construction for Emergent Patients Based on Voice and Image Recognition Technology #### Organization Study ID Info **ID:** SNUEMSAVTR #### Organization **Class:** OTHER **Full Name:** Seoul National University Hospital ### Status Module #### Completion Date **Date:** 2022-05-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-11-01 **Type:** ACTUAL **Last Update Submit Date:** 2022-10-30 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-05-31 **Type:** ACTUAL #### Start Date **Date:** 2020-02-12 **Type:** ACTUAL **Status Verified Date:** 2022-05 #### Study First Post Date **Date:** 2021-06-09 **Type:** ACTUAL **Study First Submit Date:** 2021-06-01 **Study First Submit QC Date:** 2021-06-08 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** National Research Foundation of Korea #### Lead Sponsor **Class:** OTHER **Name:** Seoul National University Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Video and audio data of the triage process of emergency department (ED) patients will be collected to build a database. Clinical information retrieved from the database with voice and image technology will be used to determine the triage level of each patient and will be compared with the actual triage level. **Detailed Description:** Study Objectives: 1. To develop a platform to record video and audio data of the ED triage process. 2. To retrieve clinical information using voice and image technology. 3. To develop a tool to determine ED triage level using voice and image technology. 4. To build a clinical database using video and audio data using voice and image technology. Study design: Single center observational study (tertiary hospital emergency department in Korea). A platform to record video and audio data of the ED triage process will be developed. The camera and microphone will be installed at an optimal location to retrieve video and audio data in the ED triage area. Voice and image technology will be used to retrieve clinical information including demographic information, chief complaint, type and onset of symptoms, past medical history, and physical examination results to build a database. Clinical information including examination notes, diagnosis, patient vital signs, test results, and ED results will be retrieved from the hospital database. ### Conditions Module **Conditions:** - Emergencies **Keywords:** - Triage - Emergency department - Voice recognition - Image recognition ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 428 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Korean triage and acuity scale (KTAS) which was developed based on Canadian triage and acuity scale (CTAS) is used in Korea. KTAS is composed of 5 levels: level 1, resuscitation; level 2, emergent; level 3, urgent; level 4, less urgent; level 5, non-urgent. Emergency department triage level will be assessed by using voice/image technology and will be compared with the triage level assessed by nurses/physicians. The triage level will be assessed during emergency department triage. **Measure:** The degree of agreement between emergency department triage level retrieved using voice/image technology and by nurses/physicians. **Time Frame:** At the time of study completion (May 2022 anticipated). ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 19 years or older * Visited the emergency department of the study hospital Exclusion Criteria: * Patients who do not agree to enroll to this study * Without a family * Foreign patients **Minimum Age:** 19 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adults who visit the emergency department without one of the exclusion criteria will be enrolled in this study. ### Contacts Locations Module #### Locations **Location 1:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Seoul National University Hospital **Zip:** 03080 #### Overall Officials **Official 1:** **Affiliation:** Seoul National University Hospital **Name:** Ki Jeong Hong, PhD **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7796 - Name: Emergencies - Relevance: HIGH - As Found: Emergency - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004630 - Term: Emergencies ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01918579 **Acronym:** CRP **Brief Title:** C Reactive Protein (CRP) Intervention to Reduce Inappropriate Antibiotic Prescriptions in the Primary Healthcare Setting **Official Title:** Efficacy of Point-of-care (POC) C-reactive Protein Testing to Reduce Inappropriate Use of Antibiotics for Acute Respiratory Infections (ARIs) in the Primary Health Care Setting of Hanoi - a Randomized Controlled Trial #### Organization Study ID Info **ID:** 05HN #### Organization **Class:** OTHER **Full Name:** Oxford University Clinical Research Unit, Vietnam ### Status Module #### Completion Date **Date:** 2015-09 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2016-11-15 **Type:** ESTIMATED **Last Update Submit Date:** 2016-11-13 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2015-07 **Type:** ACTUAL #### Start Date **Date:** 2014-03 **Status Verified Date:** 2014-06 #### Study First Post Date **Date:** 2013-08-07 **Type:** ESTIMATED **Study First Submit Date:** 2013-08-06 **Study First Submit QC Date:** 2013-08-06 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** National Hospital for Tropical Diseases, Hanoi, Vietnam #### Lead Sponsor **Class:** OTHER **Name:** Oxford University Clinical Research Unit, Vietnam #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** Many studies have showed that rapid point-of-care (POC) c-reactive protein (CRP) test can reduce inappropriate use of antibiotic at primary health care level. In Vietnam, prevalence of antibiotic abuse for community acute respiratory infection has been reported. This study will test the hypothesis that CRP POC testing for patients with non-severe acute respiratory illness at primary healthcare stations reduces inappropriate antibiotic use safely. The study will be conducted at ten district health care facilities in Hanoi, Viet Nam. Investigators intend to enroll 2,000 participants aged 6-65 years with non-severe acute respiratory infection. Patients will be randomly allocated to the control or the intervention arm. Participants in the control group will be treated according to routine care. Participants in the intervention arm will have a CRP test, the results of which will be available to the health care practitioner to contribute to their diagnosis and treatment decisions. All patients will be followed-up via telephone call after 14 days. The study will compare the proportion of patients in each arm receiving any antibiotics within 2 weeks of study enrollment. ### Conditions Module **Conditions:** - Acute Respiratory Infections ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 2037 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will be tested by rapid POC CRP test **Intervention Names:** - Procedure: Patients will be tested by rapid POC CRP test **Label:** CRP intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients will not be tested by rapid POC CRP test **Label:** Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - CRP intervention **Description:** Patient will be tested with CRP test. Treatment decisions including any antibiotics prescribed will be based on test results and clinical judgement. Treatment choices are not recommended/prescribed by the study protocol. **Name:** Patients will be tested by rapid POC CRP test **Type:** PROCEDURE ### Outcomes Module #### Other Outcomes **Description:** Patients and health center staff will be interviewed by structured questionnaire to assess their attitudes and satisfaction toward the intervention. The Likert scale will be used for quantifying attitude orientation of interviewees **Measure:** The attitudes and satisfaction of patients and health center staff towards the test. **Time Frame:** 2 weeks #### Primary Outcomes **Description:** Number of patients receiving any antibiotic within 2 weeks of study enrollment as a proportion of the total number of patients. **Measure:** Proportion of patients receiving any antibiotic **Time Frame:** 2 weeks #### Secondary Outcomes **Description:** Number of days that symptoms (including fever or any respiratory symptom) endure. **Measure:** Duration of symptoms **Time Frame:** 2 weeks **Description:** Number of visits to a health care practitioner during the 14 day follow-up. **Measure:** Frequency of re-consultation **Time Frame:** 2 weeks **Description:** Number of serious adverse events which occur during the 14 day follow-up period. **Measure:** Frequency of serious adverse events **Time Frame:** 2 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients, aged 6 to 65 years, that visit one of the 10 selected primary healthcare centers * Suspected to have acute respiratory tract infection (ARI) by treating physician * Informed consent Exclusion Criteria: * Severe respiratory disease as determined by treating doctor * Any disease or symptom requiring hospital referral as determined by treating doctor * Immunosuppressed patients (e.g. HIV, long term steroid use) * Suspicion of tuberculosis * Evidence of acute or chronic liver disease (e.g. hepatitis or cirrhosis due to any cause) * Past medical history of: neoplastic disease, congestive cardiac failure, chronic obstructive pulmonary disease, insulin-dependent diabetes or renal disease * Pregnancy * No access to telephone * Not able to come for follow up visit on day 3 or 4. * Already taking antibiotics at the time of presentation * Symptoms present for more than 2 weeks * Presence of any sign of severe diseases as defined by the British Thoracic Society modified CRP-65 system for severity scoring of pneumonia in primary care. For children (Age ≥ 6 years and \< 16 years) additional exclusion criteria include: Tachypnea, signs of chest wall in drawing, reduced consciousness, confusion, dehydration, hypothermia, severe malnutrition, unable to feed or drink, vomiting, and convulsions. **Maximum Age:** 65 Years **Minimum Age:** 6 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Hanoi **Country:** Vietnam **Facility:** National Hospital for Tropical Diseases **Zip:** 10000 #### Overall Officials **Official 1:** **Affiliation:** Oxford University Clinical Research Unit **Name:** Heiman FL Wertheim, M.D,Ph.D **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Haenssgen MJ, Charoenboon N, Do NTT, Althaus T, Khine Zaw Y, Wertheim HFL, Lubell Y. How context can impact clinical trials: a multi-country qualitative case study comparison of diagnostic biomarker test interventions. Trials. 2019 Feb 8;20(1):111. doi: 10.1186/s13063-019-3215-9. **PMID:** 30736818 **Citation:** Do NT, Ta NT, Tran NT, Than HM, Vu BT, Hoang LB, van Doorn HR, Vu DT, Cals JW, Chandna A, Lubell Y, Nadjm B, Thwaites G, Wolbers M, Nguyen KV, Wertheim HF. Point-of-care C-reactive protein testing to reduce inappropriate use of antibiotics for non-severe acute respiratory infections in Vietnamese primary health care: a randomised controlled trial. Lancet Glob Health. 2016 Sep;4(9):e633-41. doi: 10.1016/S2214-109X(16)30142-5. Epub 2016 Aug 3. Erratum In: Lancet Glob Health. 2017 Jan;5(1):e39. **PMID:** 27495137 #### See Also Links **Label:** Oxford University Clinical Research Unit, Viet Nam **URL:** http://www.oucru.org ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: HIGH - As Found: Respiratory Infection - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000012141 - Term: Respiratory Tract Infections ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00496379 **Brief Title:** ZK219477 (Sagopilone) in Patients With Breast Cancer and Brain Metastases **Official Title:** A Phase 2 Study of ZK219477 (ZK-EPO) in Patients With Breast Cancer and Brain Metastases #### Organization Study ID Info **ID:** 06-268 #### Organization **Class:** OTHER **Full Name:** Dana-Farber Cancer Institute ### Status Module #### Completion Date **Date:** 2012-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2013-03-14 **Type:** ESTIMATED **Last Update Submit Date:** 2013-03-12 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2009-10 **Type:** ACTUAL #### Results First Post Date **Date:** 2013-03-12 **Type:** ESTIMATED **Results First Submit Date:** 2012-11-30 **Results First Submit QC Date:** 2013-02-07 #### Start Date **Date:** 2007-07 **Status Verified Date:** 2013-03 #### Study First Post Date **Date:** 2007-07-04 **Type:** ESTIMATED **Study First Submit Date:** 2007-07-03 **Study First Submit QC Date:** 2007-07-03 **Why Stopped:** This study has closed to accrual early due to slow accrual. ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Brigham and Women's Hospital **Class:** INDUSTRY **Name:** Bayer **Class:** OTHER **Name:** Breast Cancer Research Foundation #### Lead Sponsor **Class:** OTHER **Name:** Nancy Lin, MD #### Responsible Party **Investigator Affiliation:** Dana-Farber Cancer Institute **Investigator Full Name:** Nancy Lin, MD **Investigator Title:** Assistant Professor of Medicine **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this research study is to determine the effects (good and bad) of ZK219477(sagopilone) on participants and their cancer. ZK219477 is a chemotherapy drug that is thought to work by interfering with the ability of cancer cells to grow and divide. It is a part of a group of drugs called "epothilones" which appear to cause shrinkage of cancer in some patients with breast cancer. It is generally difficult for chemotherapy to enter the brain. However, it is believed that ZK219477 crosses into the brain. We are also studying whether an investigational MRI scan procedure may eventually help to predict which patients will benefit from ZK219477. **Detailed Description:** * Participants will be given ZK219477 intravenously over approximately 30 minutes every three weeks. * During all treatment cycles a physical exam and questions about the participants general health and specific questions about any problems they may be having will be performed. * At least every three weeks blood tests will be done to assess the effect of ZK219477 on the body. * After every 2 cycles of treatment, participants will have additional scans to assess the effect of ZK219477 on their cancer. This will include a CT scan of the abdomen, chest, and pelvis, and an MRI of the brain. * At the time of the standard MRI, participants will be asked to undergo an additional MRI sequence, which means they will be in the MRI machine for approximately 15-20 more minutes. ### Conditions Module **Conditions:** - Breast Cancer - CNS Disease **Keywords:** - metastatic breast cancer - invasive breast cancer - brain metastases - ZK-EPO ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 15 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: ZK219477 **Label:** ZK219477 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - ZK219477 **Description:** Given intravenously over approximately 30 minutes once every 3 weeks **Name:** ZK219477 **Other Names:** - ZK-EPO - ZK-Epothilone - Sagopilone **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Objective response rate is defined as at least a 50 percent reduction in the Central Nervous system target lesion volume compared to the lesion volume at baseline. **Measure:** Objective Response Rate in the Central Nervous System (CNS) **Time Frame:** 2 years #### Secondary Outcomes **Description:** Adverse events per NCI CTCAE **Measure:** Number of Subjects With Adverse Events (Any Grade) **Time Frame:** 2 years **Description:** Non-CNS response rate (according to RECIST 1.0) limited to patients with measurable non-CNS disease **Measure:** Objective Response Rate in Non-Central Nervous System (CNS) Sites **Time Frame:** 2 years **Description:** Time from date of registration until the date of the first documentation of progression or date of death (from any cause),whichever came first, up to 2 years from registration. Progression is defined as either progression in the Central Nervous system (CNS) according to volumetric measurement (Freedman et al. 2011) and /or progression in non-Central Nervous System lesion Measured by RECIST 1.0 **Measure:** Time to Progression at Any Site. **Time Frame:** 2 years **Description:** CBR = CR + PR + SD \> 24 weeks in CNS with at least stable non-CNS disease **Measure:** Clinical Benefit Rate. **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients must have histologically or cytologically invasive breast cancer, with metastatic disease at the time of screening * Measurable Central Nervous System (CNS) disease, as defined as at least one lesion \> or equal too 10mm in longest dimension * New or progressive CNS lesions after at least one prior standard CNS-directed therapy for treatment of brain metastases, which could include surgical resection, whole brain radiotherapy (WBRT), and/or stereotactic radiosurgery (SRS). Patients must have received prior WBRT, SRS or both. * Patient has been evaluated by a radiation oncologist, who feels that the plan to evaluate systemic chemotherapy in place of additional brain radiotherapy is an acceptable option * No increase in corticosteroid use in the week prior to study entry * Any number prior lines of chemotherapy for metastatic breast cancer * 18 years of age of older * Life expectancy of greater than 12 weeks * ECOG Performance Status 0-2 * Patients must have normal organ function as outlined in the protocol Exclusion Criteria: * Patients who have had chemotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier * Patients who have had XRT within 3 weeks prior to entering the study or those who have not recovered from adverse events due to XRT * Patients may not be receiving any other investigational agent * Patients may not be receiving any cancer-directed therapy * Prior treatment with investigational chemotherapy for brain metastases * Prior treatment with epothilone for metastatic breast cancer * Leptomeningeal carcinomatosis as the only site of CNS involvement. * Concurrent treatment with an enzyme inducing antiepileptic drug, including phenytoin, carbamezepine, phenobarbital, or oxacarbazepine * More than 2 seizures over the last four weeks prior to study entry * Known contraindication to MRI or gadolinium contrast, such as cardiac pacemaker, ocular foreign body, or shrapnel * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or breastfeeding women. **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Boston **Country:** United States **Facility:** Dana-Farber Cancer Institute **State:** Massachusetts **Zip:** 02115 #### Overall Officials **Official 1:** **Affiliation:** Dana-Farber Cancer Institute **Name:** Nancy Lin, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases - ID: D000009385 - Term: Neoplastic Processes - ID: D000010335 - Term: Pathologic Processes - ID: D000016543 - Term: Central Nervous System Neoplasms - ID: D000009423 - Term: Nervous System Neoplasms - ID: D000001927 - Term: Brain Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M12307 - Name: Neoplasm Metastasis - Relevance: HIGH - As Found: Metastases - ID: M5742 - Name: Central Nervous System Diseases - Relevance: HIGH - As Found: CNS Disease - ID: M5209 - Name: Brain Neoplasms - Relevance: HIGH - As Found: Brain Metastases - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M12330 - Name: Neoplastic Processes - Relevance: LOW - As Found: Unknown - ID: M18937 - Name: Central Nervous System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12367 - Name: Nervous System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms - ID: D000009362 - Term: Neoplasm Metastasis - ID: D000001932 - Term: Brain Neoplasms - ID: D000002493 - Term: Central Nervous System Diseases ### Intervention Browse Module - Ancestors - ID: D000050257 - Term: Tubulin Modulators - ID: D000050256 - Term: Antimitotic Agents - ID: D000050258 - Term: Mitosis Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M24405 - Name: Epothilones - Relevance: HIGH - As Found: Breakthrough - ID: M256183 - Name: Sagopilone - Relevance: HIGH - As Found: TUG - ID: M26197 - Name: Tubulin Modulators - Relevance: LOW - As Found: Unknown - ID: M26196 - Name: Antimitotic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000034261 - Term: Epothilones - ID: C000530494 - Term: Sagopilone ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Sagopilone **Description:** Either 16 mg/m2 or 22 mg/m2 IV Q3W **ID:** EG000 **Other Num Affected:** 15 **Other Num at Risk:** 15 **Serious Number Affected:** 1 **Serious Number At Risk:** 15 **Title:** Sagopilone **Frequency Threshold:** 5 #### Other Events **Term:** Fatigue **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** **Term:** Alopecia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** **Term:** Neurologic-other **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Neuropathy-Sensory **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Dizziness **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Blurred/Double Vision **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Eye Pain/ Headache **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Ataxia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Muscle/Joint Pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** **Term:** Limb Pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** **Term:** Back Pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** **Term:** Urinary Incontinence **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** **Term:** Insomnia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** **Term:** Generalized Weakness **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** **Term:** Hyperglycemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Endocrine disorders **Source Vocabulary:** **Term:** Hypoglycemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Endocrine disorders **Source Vocabulary:** **Term:** Hyponatremia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** **Term:** Hypokalemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** **Term:** Bicarbonate **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** **Term:** Liver Function Tests **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** **Term:** Hypoalbuminemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** **Term:** Hypocalcemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** **Term:** Nausea/Vomiting **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Anorexia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Dyspepsia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Constipation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Mucositis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** **Term:** Hemoglobin **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** **Term:** Lymphocytes **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** **Term:** Leukocytes **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** **Term:** Neutrophils **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** **Term:** Platelets **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** **Term:** Neuropathy-Motor **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** #### Serious Events **Term:** Pulmonary Embolus **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 15 **Num Events:** 1 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 15 **Units:** Participants ### Group **ID:** BG000 **Title:** Sagopilone **Description:** Either 16 mg/m2 or 22 mg/m2 IV Q3W ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** <=18 years #### Measurement **Group ID:** BG000 **Value:** 13 **Category Title:** Between 18 and 65 years #### Measurement **Group ID:** BG000 **Value:** 2 **Category Title:** >=65 years **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 12.7 **Value:** 50.3 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 15 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 15 **Class Title:** United States **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Categorical **Unit of Measure:** Participants ### Measure 2 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age Continuous **Unit of Measure:** years ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** [email protected] **Organization:** Dana-Farber Cancer Institute **Phone:** 617-632-2335 **Title:** Dr. Nancy Lin ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ### Outcome Measure 5 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 2 - **Spread:** - **Upper Limit:** 40 - **Value:** 13.3 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 15 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 1 - **Spread:** - **Upper Limit:** 4 - **Value:** 1.4 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 13 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Objective response rate is defined as at least a 50 percent reduction in the Central Nervous system target lesion volume compared to the lesion volume at baseline. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** The study was closed prior to full accrual as detailed in the manuscript **Reporting Status:** POSTED **Time Frame:** 2 years **Title:** Objective Response Rate in the Central Nervous System (CNS) **Type:** PRIMARY **Unit of Measure:** percentage of participants ##### Group **Description:** Either 16 mg/m2 or 22 mg/m2 IV Q3W **ID:** OG000 **Title:** Sagopilone #### Outcome Measure 2 **Description:** Adverse events per NCI CTCAE **Parameter Type:** NUMBER **Population Description:** Study was closed prior to full accrual for reasons detailed in published manuscript **Reporting Status:** POSTED **Time Frame:** 2 years **Title:** Number of Subjects With Adverse Events (Any Grade) **Type:** SECONDARY **Unit of Measure:** participants ##### Group **Description:** Either 16 mg/m2 or 22 mg/m2 IV Q3W **ID:** OG000 **Title:** Sagopilone #### Outcome Measure 3 **Description:** Non-CNS response rate (according to RECIST 1.0) limited to patients with measurable non-CNS disease **Parameter Type:** NUMBER **Population Description:** only included the 8 pts with measurable non-CNS disease at baseline. The 7 pts with non-measurable non-CNS disease at baseline were not included in the denominator for this endpoint **Reporting Status:** POSTED **Time Frame:** 2 years **Title:** Objective Response Rate in Non-Central Nervous System (CNS) Sites **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** Either 16 mg/m2 or 22 mg/m2 IV Q3W **ID:** OG000 **Title:** Sagopilone #### Outcome Measure 4 **Description:** Time from date of registration until the date of the first documentation of progression or date of death (from any cause),whichever came first, up to 2 years from registration. Progression is defined as either progression in the Central Nervous system (CNS) according to volumetric measurement (Freedman et al. 2011) and /or progression in non-Central Nervous System lesion Measured by RECIST 1.0 **Dispersion Type:** Full Range **Parameter Type:** MEDIAN **Population Description:** all patients who received at least 1 dose of protocol therapy **Reporting Status:** POSTED **Time Frame:** 2 years **Title:** Time to Progression at Any Site. **Type:** SECONDARY **Unit of Measure:** months ##### Group **Description:** Either 16 mg/m2 or 22 mg/m2 IV Q3W **ID:** OG000 **Title:** Sagopilone #### Outcome Measure 5 **Description:** CBR = CR + PR + SD \> 24 weeks in CNS with at least stable non-CNS disease **Parameter Type:** NUMBER **Population Description:** all pts who received at least 1 dose of protocol therapy **Reporting Status:** POSTED **Time Frame:** 2 years **Title:** Clinical Benefit Rate. **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** Either 16 mg/m2 or 22 mg/m2 IV Q3W **ID:** OG000 **Title:** Sagopilone ### Participant Flow Module #### Group **Description:** Either 16 mg/m2 or 22 mg/m2 IV Q3W **ID:** FG000 **Title:** Sagopilone #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 15 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 15 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 **Recruitment Details:** Patients were enrolled at Dana-Farber/Harvard Cancer Center between 8/1/2007-10/29/2009. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT03053479 **Acronym:** SAME **Brief Title:** Comparison of the Efficacy of Sacrocolpopexy, the Amreich-Richter Procedure and Transvaginal Mesh **Official Title:** Comparison of the Efficacy of Three Surgical Methods in the Treatment of POP: Sacrocolpopexy,the Amreich-Richter Procedure and Transvaginal Mesh #### Organization Study ID Info **ID:** SAME #### Organization **Class:** OTHER **Full Name:** Charles University, Czech Republic ### Status Module #### Completion Date **Date:** 2028-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-02-15 **Type:** ACTUAL **Last Update Submit Date:** 2023-02-12 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2025-03 **Type:** ESTIMATED #### Start Date **Date:** 2016-09-01 **Type:** ACTUAL **Status Verified Date:** 2023-02 #### Study First Post Date **Date:** 2017-02-15 **Type:** ACTUAL **Study First Submit Date:** 2017-02-08 **Study First Submit QC Date:** 2017-02-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Charles University, Czech Republic #### Responsible Party **Investigator Affiliation:** Charles University, Czech Republic **Investigator Full Name:** Kamil Svabik **Investigator Title:** MD PhD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Pelvic organ prolapse, POP, is a common health problem affecting up to 40% of women. Very little is known about the factors associated with surgical failure. Studies have identified a variety of risk factors: younger age, high body mass index and advanced preoperative prolapse (grade III-IV) have been associated with an increased risk of reoperation in some studies. According to some studies patients had poorer anatomical outcome after traditional repairs but were able to enjoy the same quality of life as after transvaginal mesh surgery or laparoscopic sacrocolpopexy. The purpose of this study is to assess and compare the efficacy of these three procedures in a randomized controlled trial. **Detailed Description:** Pelvic organ prolapse, POP, is a common health problem affecting up to 40% of women. The lifetime likelihood of undergoing at least one incident of pelvic organ prolapse surgery has been estimated at approximately 13%. The prevalence of reoperation after primary pelvic reconstructive surgery is high at around 30%, while some studies report the figure as up to 58%. In the early 1990s the perception of pelvic floor defects and urinary incontinence in women started to change significantly. The diagnostics and management of these defects became an independent uro-gynecological sub-specialization within gynaecology and obstetrics, and it has been included among 4 basic sub-specializations recognized by the European Board and College of Obstetrics and Gynecology. Surgical treatment is indicated in women with symptomatic POP when conservative management has failed or has been declined. There is no indication for repair of asymptomatic POP as an isolated procedure where surgical correction is of uncertain benefit and adds peri- and post-operative risks. The objective of our treatment should always aim to restore quality of life and comfort. Very little is known about the factors associated with surgical failure. Studies have identified a variety of risk factors: younger age, high body mass index and advanced preoperative prolapse (grade III-IV) have been associated with an increased risk of reoperation in some studies, while other studies did not prove these hypotheses. One factor which significantly influences the result of the pelvic organ surgery is the presence of pelvic floor injury. Injury of the musculus levator ani mainly affects the results of traditional vaginal wall repair, with 60% risk of recurrence. In the last few years, in an attempt to reduce recurrence and improve the outcome of reconstructive surgery in the treatment of pelvic organ prolapse, surgeons have started to use transvaginally introduced prosthetic material (mesh). This type of surgery significantly increases the efficacy of the procedure (anatomic cure rate over 90%), but its use is associated with a risk of some complications (vaginal erosions and potential consecutive infections, granulomas, dyspareunia, vesico-vaginal fistulas, chronic pain) thereby potentially reducing patient quality of life and leading to additional surgery. If the mesh is introduced during sacrocolpopexy and the vaginal wall is not open, there is a significant decrease of mesh-related complications. Laparoscopic sacrocolpopexy is considered the gold standard for the management of apical prolapse with high long-term efficacy. According to some studies patients had poorer anatomical outcome after traditional repairs but were able to enjoy the same quality of life as after transvaginal mesh surgery or laparoscopic sacrocolpopexy. Therefore the investigators plan to assess the efficacy in a randomized trial of three different surgical methods (the Amreich-Richter procedure, transvaginal mesh and laparoscopic sacrocolpopexy) in patients with high risk of recurrence; i.e. patients with advanced pelvic organ prolapse (at least stage III) and proved injury of pelvic floor muscles. Aims of the study: To evaluate on the basis of a prospective randomized trial the clinical efficacy of three different surgical procedures (the Amreich-Richter procedure, transvaginal mesh and laparoscopic sacrocolpopexy) in women with advanced pelvic organ prolapse and proved pelvic floor muscle injury All patients will undergo complete urogynecological investigation before the procedure (history, clinical examination, assessment of pelvic organ prolapse using the POPQ system, examination of the levator resting tone and contraction (Oxford scale),where appropriate urodynamics according to ICS recommendation and ultrasound examination), and they will fill in standardized international questionnaires (ICIQ-UI SF, PISQ 12, UDI_POPDI-CRADI, POP-SF). Ultrasound examinations will be performed as a combined examination using a convex probe, from abdominal and perineal approaches, and sectoral vaginal probe from the introital approach. Investigation will be preserved mainly in digital form and partly on videotapes. Acquired data from 4D imagery will be preserved in the form of data set and processed with appropriate software. Ultrasound examination will assess standards parameters describing position of the urethrovesical junction, bladder descent, uterus descent, posterior vaginal wall descent (rectocele, enterocele). Using 3D/4D ultrasound examination the status of the pelvic floor will be evaluated (presence of avulsion of puborectalis muscle, abnormal genital hiatus distension). Women will be randomized into three groups: 1. Group - Laparoscopic sacrocolpopexy 2. Group - Transvaginal mesh procedure 3. Group - Amreich-Richter procedure (traditional vaginal wall repair with apical fixation to sacrospinous ligament. All surgical procedures will be performed under general, spinal or epidural anesthesia where indicated, and antibiotic prophylaxis will be used. Surgery will be provided in standardized steps, see arm descriptions. In an early postoperative check-up 2-3 weeks after surgery evaluation of post-operative pain will be performed and late post-operative complication such as de novo constipation, urinary retention, infections analyzed. The next post-operative complete examination is planned for 3 months after surgery (the same examination as before the procedure including clinical exam, ultrasound the QoL (ICIQ- SF, POP-SF, PISQ 12, UDI_POPDI-CRADI, TS-VAS). The next visits will be provided one year and two years after surgery, and the procedure will be the same as at the 3-month check-up. In addition to pre-operative ultrasound examination the position of the mesh will be monitored. All patients in this study will have a minimum one year follow-up and, whenever possible, a two year follow-up. Postoperative follow-up will be terminated if the result of surgery is evaluated as a failure, and in these cases reoperation will be offered. Further post-operative follow-up up to five years is also planned. ### Conditions Module **Conditions:** - Pelvic Organ Prolapse **Keywords:** - surgery - native tissue prolapse repair - laparoscopic sacrocolpopexy - vaginal mesh ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 462 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Laparoscopic sacrocolpopexy will be performed in the following way: Identification of the promontory, dissection of the peritoneum above the promontory and preparation of the ligamentum longitudinale anterior, peritoneum dissection, dissection of the vesicovaginal septum up to the bladder neck, dissection of the rectovaginal septum towards the perineum, application of Y mesh, fixation to the vaginal apex using non-absorbable sutures, and for anterior and posterior vaginal wall absorbable sutures. Fixation of the upper mesh arm to the ligamentum longitudinale anterior using non-absorbable suture, following with complete peritoneum closure above the mesh. The procedure could include salpingo-oophorectomy, supracervical hysterectomy or total hysterectomy (concomitant procedures are not exclusion criteria). **Intervention Names:** - Procedure: Laparoscopic sacrocolpopexy **Label:** Laparoscopic sacrocolpopexy **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Hydrodissection of the anterior vaginal wall, midline anterior colporrhaphy, preparation beyond the endopelvic fascia, mesh kit with bilateral fixation to sacrospinous ligaments should be used. The procedure could include salpingo-oophorectomy, total hysterectomy and posterior vaginal wall repair (concomitant procedures are not exclusion criteria). **Intervention Names:** - Procedure: Transvaginal mesh procedure **Label:** Transvaginal mesh procedure **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** At least unilateral fixation with non-absorbable suture to sacrospinous ligament (fixation could be performed from the anterior approach). At the time of anterior vaginal wall repair or traditional posterior approach, it is possible to use a device for stich fixation (for example Capio, I- stitch etc). The procedure could include salpingo-oophorectomy, total hysterectomy and posterior vaginal wall repair (concomitant procedures are not exclusion criteria). **Intervention Names:** - Procedure: Amreich-Richter procedure **Label:** Amreich-Richter procedure: **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Laparoscopic sacrocolpopexy **Description:** see arm/group descriptions **Name:** Laparoscopic sacrocolpopexy **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Transvaginal mesh procedure **Description:** see arm/group descriptions **Name:** Transvaginal mesh procedure **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Amreich-Richter procedure: **Description:** see arm/group descriptions **Name:** Amreich-Richter procedure **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** absence of pelvic organ prolapse (using the POPQ system - maximal I. stage prolapse) **Measure:** Objective cure rate **Time Frame:** 2 years **Description:** failure is defined as pelvic organ prolapse stage II or higher using the POPQ system during the clinical examination, or as a descent 1 cm below the lower edge of pubic bone based on ultrasound examination. **Measure:** Number of failures in each group **Time Frame:** 2 years **Description:** new occurence of painful sexual intercourse after the surgery. **Measure:** de novo dyspareunia **Time Frame:** 2 years **Description:** extrusion rate, pain **Measure:** mesh related complications **Time Frame:** 2 years #### Secondary Outcomes **Description:** Measured at Valsalva from rendered 4D volume **Measure:** Change of the genital hiatus size **Time Frame:** 2 years **Description:** Measured from sagittal plane, transperineal ultrasound **Measure:** Distance of mesh from the bladder neck **Time Frame:** 2 years **Description:** Measured from sagittal plane, transperineal ultrasound at Valsalva. Distance in relation to a horizontal line at the level of symphysis. **Measure:** Lowest position of the mesh **Time Frame:** 2 years **Description:** International Consultation on Incontinence questionnaire, urinary incontinence, short form **Measure:** ICIQ-UI SF **Time Frame:** 2 years **Description:** Pelvic organ prolapse symptom scale **Measure:** POP-SS **Time Frame:** 2 years **Description:** Prolapse/incontinence sexual questionnaire **Measure:** PISQ-12 **Time Frame:** 2 years **Description:** Pelvic floor distress inventory **Measure:** PFDI **Time Frame:** 2 years **Description:** Treatment satisfaction - visual analog scale **Measure:** TS-VAS **Time Frame:** 2 years **Description:** any occurence **Measure:** de novo stress urinary incontinence **Time Frame:** 2 years **Description:** any occurence **Measure:** de novo symptoms of overactive bladder **Time Frame:** 2 years **Description:** rate **Measure:** reoperation for pelvic organ prolapse recurrence **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * age over18 * signed informed consent * symptomatic pelvic organ prolapse stage III or higher (according to the International Continence Society Pelvic Organ Prolapse quantification system - POPQ) in anterior and apical (central) compartments, one at least stage II and the second at least stage III * presence of at least a unilateral avulsion injury of the puborectalis muscle * agreement with postoperative follow-up. Exclusion Criteria: * previous pelvic reconstructive surgery with mesh * isolated posterior compartment prolapse * previous radiotherapy in true pelvis * contraindication for one of the planned surgical methods. **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Frýdek-Místek **Country:** Czechia **Facility:** Frýdek-Místek regional hospital **Zip:** 73801 **Location 2:** **City:** Olomouc **Country:** Czechia **Facility:** Faculty of Medicine in Olomouc, Palackeho University **Location 3:** **City:** Plzen **Country:** Czechia **Facility:** Faculty of Medicine in Pilsen, Charles University **Zip:** 30460 **Location 4:** **City:** Prague **Country:** Czechia **Facility:** General University Hospital, 1st Faculty of Medicine, Charles University **Zip:** 12800 **Location 5:** **City:** Prague **Country:** Czechia **Facility:** Hospital Na Bulovce, 1st Faculty of Medicine, Charles University **Zip:** 18000 **Location 6:** **City:** Zlin **Country:** Czechia **Facility:** Tomas Bata Regional Hospital in Zlin **Zip:** 762 75 **Location 7:** **City:** Košice **Country:** Slovakia **Facility:** Louis Pasteur University Hospital Kosice **Zip:** 04011 ### IPD Sharing Statement Module **Description:** IPD sharing not planned **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020763 - Term: Pathological Conditions, Anatomical ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14261 - Name: Prolapse - Relevance: HIGH - As Found: Prolapse - ID: M28618 - Name: Pelvic Organ Prolapse - Relevance: HIGH - As Found: Pelvic Organ Prolapse - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011391 - Term: Prolapse - ID: D000056887 - Term: Pelvic Organ Prolapse ### Misc Info Module #### Removed Countries - Country: Czech Republic - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02775279 **Brief Title:** Association Between Telomere Length and Risk of Acute Coronary Syndrome **Official Title:** Short Telomere Length in Peripheral Blood Leukocyte Predicts the Risk of Acute Coronary Syndrome #### Organization Study ID Info **ID:** XJ20160520 #### Organization **Class:** OTHER **Full Name:** Air Force Military Medical University, China ### Status Module #### Completion Date **Date:** 2016-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2016-05-17 **Type:** ESTIMATED **Last Update Submit Date:** 2016-05-14 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2016-05 **Type:** ACTUAL #### Start Date **Date:** 2016-01 **Status Verified Date:** 2016-05 #### Study First Post Date **Date:** 2016-05-17 **Type:** ESTIMATED **Study First Submit Date:** 2016-05-14 **Study First Submit QC Date:** 2016-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Air Force Military Medical University, China #### Responsible Party **Investigator Affiliation:** Air Force Military Medical University, China **Investigator Full Name:** Wenyi Guo **Investigator Title:** Professor of Department of Cardiovascular Medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Compelling epidemiological evidence indicates that alterations length of telomere, are associated with the initiation and development of ischemic heart disease. This study was undertaken to investigate whether mtDNA copy number in peripheral blood leukocyte could be used as a risk predictor for acute coronary syndrome. ### Conditions Module **Conditions:** - Acute Coronary Syndrome **Keywords:** - acute coronary syndrome, telomere length, predictive factor ### Design Module #### Bio Spec **Description:** Telomeres consist of a tandem TTAGG repeat located at ends of linear chromosomes of eukaryote cells that often decrease in length over time (largely due to oxidative damage and the end replication problem during cell division) and may trigger cellular senescence once telomere become critically short **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 400 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 200 consecutive patients were recruited, who have diagnosed with acute coronary syndrom(ACS) by quantitative coronary angiography. **Label:** Acute coronary syndrome group #### Arm Group 2 **Description:** The 200 healthy controls without previous CHD history were recruited from individuals who visited investigator's hospital for physical examination during the same time period as the case enrollment. **Label:** Control group ### Outcomes Module #### Primary Outcomes **Description:** the ratio of telomere repeat copy number(T) to the hemoglobin(HGB) copy number (S) was determined for each sample using standard curves. The derived T/S ratio was proportional to the relative telomere length(RTL). In the second step, the T/S ratio of each sample was normalized to a calibrator DNA to standardize between different PCR runs. The calibrated T/S ratio was then used as the measurement of RTL in this study. **Measure:** Relative telomere length **Time Frame:** From date of percutaneous coronary intervention until the date of discharging from hospital, assessed up to 5 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: -1.History of documented myocardial infarction; 2.Prior coronary revascularization intervention (coronary artery bypass graft surgery or percutaneous coronary intervention); 3.The presence of≥50% stenosis in one or more coronary arteries identified during cardiac catheterization; Exclusion Criteria: -1.History of malignancy or end-stage renal disease; 2.Blood transfusion within one month or prior bone marrow transplantation 3.Patients who reluctant to sign informed consent **Healthy Volunteers:** True **Maximum Age:** 85 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** A total of 200 eligible ACS patients were anticipated to include in this study.Moreover, The 200 healthy controls without previous CHD history were also recruited from individuals who visited investigator's hospital for physical examination during the same time period. ### Contacts Locations Module #### Locations **Location 1:** **City:** Xi'an **Country:** China **Facility:** Xijing Hospital **State:** Shaanxi **Zip:** 710032 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000017202 - Term: Myocardial Ischemia - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000014652 - Term: Vascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M27545 - Name: Acute Coronary Syndrome - Relevance: HIGH - As Found: Acute Coronary Syndrome - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M6546 - Name: Coronary Artery Disease - Relevance: LOW - As Found: Unknown - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000054058 - Term: Acute Coronary Syndrome - ID: D000013577 - Term: Syndrome ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00658879 **Brief Title:** Long Term Use of Somavert (Pegvisomant) For A Regulatory Post Marketing Commitment Plan **Official Title:** SPECIAL INVESTIGATION OF SOMAVERT -LONG TERM USE- #### Organization Study ID Info **ID:** A6291023 #### Organization **Class:** INDUSTRY **Full Name:** Pfizer ### Status Module #### Completion Date **Date:** 2016-11-09 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-09-25 **Type:** ACTUAL **Last Update Submit Date:** 2023-08-31 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2016-11-09 **Type:** ACTUAL #### Results First Post Date **Date:** 2019-01-22 **Type:** ACTUAL **Results First Submit Date:** 2017-09-26 **Results First Submit QC Date:** 2018-08-09 #### Start Date **Date:** 2007-08-07 **Type:** ACTUAL **Status Verified Date:** 2023-08 #### Study First Post Date **Date:** 2008-04-15 **Type:** ESTIMATED **Study First Submit Date:** 2008-04-09 **Study First Submit QC Date:** 2008-04-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Pfizer #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug. **Detailed Description:** All the patients whom an investigator prescribes the first Somavert (Pegvisomant) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random. ### Conditions Module **Conditions:** - Acromegaly ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 251 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients taking Somavert (Pegvisomant). **Intervention Names:** - Drug: Somavert (Pegvisomant) **Label:** Somavert (Pegvisomant) ### Interventions #### Intervention 1 **Arm Group Labels:** - Somavert (Pegvisomant) **Description:** Somavert (Pegvisomant) 10, 15 or 20mg powder and solvent for solution for injection. Dosage, Frequency : According to Japanese LPD. Duration : According to the protocol of A6291023, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 5 years after the first administration. **Name:** Somavert (Pegvisomant) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Somavert was assessed by the physician. **Measure:** Number of Participants With Treatment-Related Adverse Events **Time Frame:** 5 years **Description:** A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to Somavert was assessed by the physician. **Measure:** Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert **Time Frame:** 5 years **Description:** A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by gender to assess whether it was a risk factor for the occurrence of treatment-related adverse events. **Measure:** Number of Participants With Treatment-Related Adverse Events by Gender **Time Frame:** 5 years **Description:** A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by age to assess whether it was a risk factor for the occurrence of treatment-related adverse events. **Measure:** Number of Participants With Treatment-Related Adverse Events by Age **Time Frame:** 5 years **Description:** A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by hepatic function disorder to assess whether it was a risk factor for the occurrence of treatment-related adverse events. **Measure:** Number of Participants With Treatment-Related Adverse Events for Participants With Hepatic Function Disorder **Time Frame:** 5 years **Description:** A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by renal impairment to assess whether it was a risk factor for the occurrence of treatment-related adverse events. **Measure:** Number of Participants With Treatment-Related Adverse Events for Participants With Renal Impairment **Time Frame:** 5 years **Description:** A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by diabetes mellitus (concurrent disease) to assess whether it was a risk factor for the occurrence of treatment-related adverse events. **Measure:** Number of Participants With Treatment-Related Adverse Events for Participants With Diabetes Mellitus (Concurrent Disease) **Time Frame:** 5 years **Description:** Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. **Measure:** Clinical Effectiveness Rate **Time Frame:** 5 years **Description:** Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by gender were counted to assess whether it contributes to the clinical effectiveness. **Measure:** Clinical Effectiveness Rate by Gender **Time Frame:** 5 years **Description:** Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by age were counted to assess whether it contributes to the clinical effectiveness. **Measure:** Clinical Effectiveness Rate by Age **Time Frame:** 5 years **Description:** Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by hepatic function disorder were counted to assess whether it contributes to the clinical effectiveness. **Measure:** Clinical Effectiveness Rate in Participants With Hepatic Function Disorder **Time Frame:** 5 years **Description:** Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by diabetes mellitus (concurrent disease) were counted to assess whether it contributes to the clinical effectiveness. **Measure:** Clinical Effectiveness Rate in Participants With Diabetes Mellitus (Concurrent Disease) **Time Frame:** 5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Patients need to be administered Somavert (Pegvisomant) in order to be enrolled in the surveillance. Exclusion Criteria: Patients not administered Somavert (Pegvisomant). **Minimum Age:** 0 Days **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** The patients whom an investigator involving A6291023 prescribes Somavert (Pegvisomant). ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Pfizer **Name:** Pfizer CT.gov Call Center **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests. **IPD Sharing:** NO ### References Module #### See Also Links **Label:** To obtain contact information for a study center near you, click here. **URL:** https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6291023&StudyName=Long%20Term%20Use%20of%20Pegvisomant%20For%20A%20Regulatory%20Post%20Marketing%20Commitment%20Plan%20 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001849 - Term: Bone Diseases, Endocrine - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000006964 - Term: Hyperpituitarism - ID: D000010900 - Term: Pituitary Diseases - ID: D000007027 - Term: Hypothalamic Diseases - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M3531 - Name: Acromegaly - Relevance: HIGH - As Found: Acromegaly - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M5128 - Name: Bone Diseases, Endocrine - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M13791 - Name: Pituitary Diseases - Relevance: LOW - As Found: Unknown - ID: M10077 - Name: Hypothalamic Diseases - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: T139 - Name: Acromegaly - Relevance: HIGH - As Found: Acromegaly ### Condition Browse Module - Meshes - ID: D000000172 - Term: Acromegaly ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module **Description:** The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study. #### Event Groups **Group ID:** EG000 **Title:** Somavert (Pegvisomant) **Description:** Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion. **ID:** EG000 **Other Num Affected:** 117 **Other Num at Risk:** 250 **Serious Number Affected:** 39 **Serious Number At Risk:** 250 **Title:** Somavert (Pegvisomant) **Frequency Threshold:** 0 #### Other Events **Term:** Anaemia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Atrial fibrillation **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Deafness unilateral **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Ear and labyrinth disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Dry eye **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Eyelid ptosis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Iritis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Abdominal distension **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Abdominal pain **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Constipation **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Diarrhoea **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Large intestine polyp **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Nausea **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Vomiting **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Chest pain **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Condition aggravated **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Disease progression **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Facial pain **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Fatigue **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Induration **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Injection site erythema **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Injection site hypertrophy **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Injection site induration **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Injection site pain **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Injection site pruritus **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Injection site swelling **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Malaise **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Alcoholic liver disease **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Cholangitis acute **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Cholelithiasis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Hepatic function abnormal **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Hepatic steatosis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Hyperbilirubinaemia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Liver disorder **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Bronchitis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 19.0 **Term:** Cystitis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 19.0 **Term:** Influenza **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 19.0 **Term:** Nasopharyngitis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 19.0 **Term:** Urinary tract infection **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 19.0 **Term:** Alanine aminotransferase increased **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 19.0 **Term:** Aspartate aminotransferase increased **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 19.0 **Term:** Blood alkaline phosphatase increased **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 19.0 **Term:** Blood bilirubin increased **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 19.0 **Term:** Blood glucose increased **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 19.0 **Term:** Blood growth hormone increased **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 19.0 **Term:** Blood pressure increased **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 19.0 **Term:** Gamma-glutamyltransferase increased **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 19.0 **Term:** Glycosylated haemoglobin increased **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 19.0 **Term:** Insulin-like growth factor increased **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 19.0 **Term:** Liver function test abnormal **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 19.0 **Term:** Low density lipoprotein increased **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 19.0 **Term:** Weight increased **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 19.0 **Term:** Decreased appetite **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Diabetes mellitus **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Diabetes mellitus inadequate control **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Dyslipidaemia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Glucose tolerance impaired **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Hyperglycaemia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Hyperlipidaemia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Hyperphosphatasaemia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Hyperuricaemia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Hypocalcaemia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Hypoglycaemia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Obesity **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Arthralgia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Joint lock **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Rheumatoid arthritis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Pituitary tumour **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 19.0 **Term:** Pituitary tumour recurrent **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 19.0 **Term:** Diabetic neuropathy **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Dizziness **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Headache **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Memory impairment **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Nervous system disorder **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Neuralgia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Calculus urinary **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Renal tubular acidosis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Ureteric stenosis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Benign prostatic hyperplasia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Reproductive system and breast disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Dysmenorrhoea **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Reproductive system and breast disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Endometriosis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Reproductive system and breast disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Asthma **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Cough **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Hyperventilation **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Productive cough **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Rhinalgia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Rhinitis allergic **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Sleep apnoea syndrome **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Upper respiratory tract inflammation **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Alopecia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Dermal cyst **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Pruritus **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Rash **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Urticaria **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA 19.0 **Term:** Hypertension **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 19.0 #### Serious Events **Term:** Appendicitis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Cholecystitis infective **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Pyelonephritis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Pyelonephritis acute **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Sepsis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Brain neoplasm **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Colon cancer **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Hepatic cancer metastatic **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Lung neoplasm malignant **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Metastases to lung **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Neoplasm progression **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Neoplasm skin **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Pancreatic carcinoma **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Pituitary tumour **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 8 **Num At Risk:** 250 **Term:** Pituitary tumour benign **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 250 **Term:** Pituitary tumour recurrent **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 250 **Term:** Contrast media allergy **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Immune system disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Drug hypersensitivity **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Immune system disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Hypopituitarism **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Endocrine disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Diabetes mellitus **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Hypercholesterolaemia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Altered state of consciousness **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Epilepsy **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Hydrocephalus **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Loss of consciousness **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Seizure **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Aortic valve incompetence **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Cardiac failure chronic **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Cardiac failure congestive **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 250 **Term:** Pneumonia aspiration **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Respiratory failure **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Abdominal pain **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 250 **Term:** Diverticulum intestinal haemorrhagic **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Intestinal obstruction **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 250 **Term:** Large intestine polyp **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Nausea **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Volvulus **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Drug-induced liver injury **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Hepatic function abnormal **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Liver disorder **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 5 **Num At Risk:** 250 **Term:** Osteoarthritis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Condition aggravated **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 250 **Term:** Disease progression **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 11 **Num At Risk:** 250 **Term:** Malaise **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Platelet count decreased **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** White blood cell count decreased **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Compression fracture **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Fall **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Subdural haematoma **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 **Term:** Cardiac resynchronisation therapy **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Surgical and medical procedures **Source Vocabulary:** MedDRA 19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 250 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 250 **Units:** Participants ### Group **ID:** BG000 **Title:** Somavert (Pegvisomant) **Description:** Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion. ### Measure #### Measurement **Group ID:** BG000 **Value:** 2 **Class Title:** <15 years #### Measurement **Group ID:** BG000 **Value:** 198 **Class Title:** ≥15 and <65 years #### Measurement **Group ID:** BG000 **Value:** 50 **Class Title:** ≥65 years ### Measure #### Measurement **Group ID:** BG000 **Value:** 141 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 109 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 234 **Class Title:** Absent #### Measurement **Group ID:** BG000 **Value:** 16 **Class Title:** Present ### Measure #### Measurement **Group ID:** BG000 **Value:** 241 **Class Title:** Absent #### Measurement **Group ID:** BG000 **Value:** 9 **Class Title:** Present ### Measure #### Measurement **Group ID:** BG000 **Value:** 139 **Class Title:** Absent #### Measurement **Group ID:** BG000 **Value:** 111 **Class Title:** Present **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** NUMBER **Title:** Age, Customized **Unit of Measure:** Participants ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** NUMBER **Title:** Hepatic Function Disorder **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** NUMBER **Title:** Renal Impairment **Unit of Measure:** Participants ### Measure 5 **Parameter Type:** NUMBER **Title:** Diabetes Mellitus (Concurrent Disease) **Unit of Measure:** Participants **Population Description:** A total of 251 participants were enrolled in this study. Of the 251 participants, 1 participant was excluded from the baseline analysis due to protocol violation. ## Results Section - More Information Module ### Certain Agreement **Other Details:** Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results. **Restriction Type:** OTHER **Restrictive Agreement:** True ### Point of Contact **Email:** [email protected] **Organization:** Pfizer, Inc. **Phone:** 1-800-718-1021 **Title:** Pfizer ClinicalTrials.gov Call Center ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ### Outcome Measure 5 ### Outcome Measure 6 ### Outcome Measure 7 ### Outcome Measure 8 ### Outcome Measure 9 ### Outcome Measure 10 ### Outcome Measure 11 ### Outcome Measure 12 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 89 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 20 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 9 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 52 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 141 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 37 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 109 **Units:** Participants #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 2 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 75 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 198 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 12 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 50 **Units:** Participants #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 85 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 234 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 16 **Units:** Participants #### Outcome Measure 6 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 88 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 241 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 9 **Units:** Participants #### Outcome Measure 7 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 57 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 139 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 32 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 111 **Units:** Participants #### Outcome Measure 8 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 96.4 **Title:** #### Outcome Measure 9 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 96.8 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 126 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 96.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 99 **Units:** Participants #### Outcome Measure 10 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 50.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 2 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 96.1 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 180 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 43 **Units:** Participants #### Outcome Measure 11 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 96.7 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 212 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 92.3 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 13 **Units:** Participants #### Outcome Measure 12 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 96.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 126 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 97.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 99 **Units:** Participants ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Somavert was assessed by the physician. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once. **Reporting Status:** POSTED **Time Frame:** 5 years **Title:** Number of Participants With Treatment-Related Adverse Events **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion. **ID:** OG000 **Title:** Somavert (Pegvisomant) #### Outcome Measure 2 **Description:** A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to Somavert was assessed by the physician. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once. **Reporting Status:** POSTED **Time Frame:** 5 years **Title:** Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion. **ID:** OG000 **Title:** Somavert (Pegvisomant) #### Outcome Measure 3 **Description:** A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by gender to assess whether it was a risk factor for the occurrence of treatment-related adverse events. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once. **Reporting Status:** POSTED **Time Frame:** 5 years **Title:** Number of Participants With Treatment-Related Adverse Events by Gender **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion. **ID:** OG000 **Title:** Somavert (Pegvisomant) #### Outcome Measure 4 **Description:** A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by age to assess whether it was a risk factor for the occurrence of treatment-related adverse events. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once. **Reporting Status:** POSTED **Time Frame:** 5 years **Title:** Number of Participants With Treatment-Related Adverse Events by Age **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion. **ID:** OG000 **Title:** Somavert (Pegvisomant) #### Outcome Measure 5 **Description:** A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by hepatic function disorder to assess whether it was a risk factor for the occurrence of treatment-related adverse events. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once. **Reporting Status:** POSTED **Time Frame:** 5 years **Title:** Number of Participants With Treatment-Related Adverse Events for Participants With Hepatic Function Disorder **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion. **ID:** OG000 **Title:** Somavert (Pegvisomant) #### Outcome Measure 6 **Description:** A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by renal impairment to assess whether it was a risk factor for the occurrence of treatment-related adverse events. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once. **Reporting Status:** POSTED **Time Frame:** 5 years **Title:** Number of Participants With Treatment-Related Adverse Events for Participants With Renal Impairment **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion. **ID:** OG000 **Title:** Somavert (Pegvisomant) #### Outcome Measure 7 **Description:** A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by diabetes mellitus (concurrent disease) to assess whether it was a risk factor for the occurrence of treatment-related adverse events. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once. **Reporting Status:** POSTED **Time Frame:** 5 years **Title:** Number of Participants With Treatment-Related Adverse Events for Participants With Diabetes Mellitus (Concurrent Disease) **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion. **ID:** OG000 **Title:** Somavert (Pegvisomant) #### Outcome Measure 8 **Description:** Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. **Parameter Type:** NUMBER **Population Description:** The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as "unassessable" were excluded from the calculation. **Reporting Status:** POSTED **Time Frame:** 5 years **Title:** Clinical Effectiveness Rate **Type:** PRIMARY **Unit of Measure:** Percentage of Participants ##### Group **Description:** Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion. **ID:** OG000 **Title:** Somavert (Pegvisomant) #### Outcome Measure 9 **Description:** Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by gender were counted to assess whether it contributes to the clinical effectiveness. **Parameter Type:** NUMBER **Population Description:** The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as "unassessable" were excluded from the calculation. **Reporting Status:** POSTED **Time Frame:** 5 years **Title:** Clinical Effectiveness Rate by Gender **Type:** PRIMARY **Unit of Measure:** Percentage of Participants ##### Group **Description:** Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion. **ID:** OG000 **Title:** Somavert (Pegvisomant) #### Outcome Measure 10 **Description:** Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by age were counted to assess whether it contributes to the clinical effectiveness. **Parameter Type:** NUMBER **Population Description:** The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as "unassessable" were excluded from the calculation. **Reporting Status:** POSTED **Time Frame:** 5 years **Title:** Clinical Effectiveness Rate by Age **Type:** PRIMARY **Unit of Measure:** Percentage of Participants ##### Group **Description:** Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion. **ID:** OG000 **Title:** Somavert (Pegvisomant) #### Outcome Measure 11 **Description:** Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by hepatic function disorder were counted to assess whether it contributes to the clinical effectiveness. **Parameter Type:** NUMBER **Population Description:** The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as "unassessable" were excluded from the calculation. **Reporting Status:** POSTED **Time Frame:** 5 years **Title:** Clinical Effectiveness Rate in Participants With Hepatic Function Disorder **Type:** PRIMARY **Unit of Measure:** Percentage of Participants ##### Group **Description:** Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion. **ID:** OG000 **Title:** Somavert (Pegvisomant) #### Outcome Measure 12 **Description:** Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as "effective," "ineffective" or "unassessable" by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by diabetes mellitus (concurrent disease) were counted to assess whether it contributes to the clinical effectiveness. **Parameter Type:** NUMBER **Population Description:** The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as "unassessable" were excluded from the calculation. **Reporting Status:** POSTED **Time Frame:** 5 years **Title:** Clinical Effectiveness Rate in Participants With Diabetes Mellitus (Concurrent Disease) **Type:** PRIMARY **Unit of Measure:** Percentage of Participants ##### Group **Description:** Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion. **ID:** OG000 **Title:** Somavert (Pegvisomant) ### Participant Flow Module #### Group **Description:** Participants who received Somavert as indicated in the approved local product document were observed for a period of 5 years. The dosage can be adjusted as per physician's discretion. **ID:** FG000 **Title:** Somavert (Pegvisomant) #### Period **Title:** Overall Study ##### Withdraw **Type:** Protocol Violation ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 251 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 250 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 1 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT06407479 **Brief Title:** Comparison of Eccentric Muscle Training and Proprioceptive Neuromuscular Facilitation Techniques in Neck Pain **Official Title:** Comparison of Eccentric Muscle Training and Proprioceptive Neuromuscular Facilitation Techniques in Individuals With Non-specific Neck Pain #### Organization Study ID Info **ID:** Uskudar4 #### Organization **Class:** OTHER **Full Name:** Uskudar University ### Status Module #### Completion Date **Date:** 2024-08-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-10 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-09 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-09 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-06 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Uskudar University #### Responsible Party **Investigator Affiliation:** Uskudar University **Investigator Full Name:** Dr. Öğr. Üyesi Ömer Şevgin **Investigator Title:** Asst. Prof. Dr. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** It was aimed to compare the eccentric exercise training given to the neck muscles of people with non-specific neck pain and the proprioceptive neuromuscular facilitation (PNF) technique on pain, endurance and functionality. **Detailed Description:** The study was planned as a quantitative study. Volunteer individuals with nonspecific neck pain between the ages of 18-65 will be included in the study, and the participants will be randomly distributed into 3 groups. Control group (n=15), proprioceptive neuromuscular facilitation technique application group (n=15), eccentric muscle training technique application group (n=15). People included in the study will be explained in detail and will be asked to sign a voluntary consent form approved by the ethics committee. Demographic information of individuals in all three groups will be recorded first. Participants in all three groups will be evaluated at the beginning and end of the applications. In our study, participants were evaluated with the McGill Pain Questionnaire to evaluate the character and character of pain, their physical fitness with the Deep Neck Flexor Endurance Test (DBFET), their functionality related to daily living activities with the Neck Disability Index (NEI), and their quality of life with the World Health Organization Short Form of Quality of Life (WHOYKA-CF). ) Tampa Kinesiophobia Scale (TKÖ) and a goniometer for Cervical Region Joint Range of Motion Measurement will be used to evaluate kinesiophobia, which is the fear of pain and re-injury, as well as anxiety towards activity and physical movement. This study will be planned five times a week for six weeks. Stretching and stabilization exercises will be applied to the control group in 3 sets of 10 repetitions. ### Conditions Module **Conditions:** - Neck Pain - Chronic Pain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 45 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** proprioceptive neuromuscular facilitation technique application **Intervention Names:** - Other: proprioceptive neuromuscular facilitation technique group **Label:** proprioceptive **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** eccentric muscle training technique application **Intervention Names:** - Other: eccentric muscle training technique application group **Label:** eccentric **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** no intervention group **Intervention Names:** - Other: Control **Label:** Control **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - proprioceptive **Description:** Proprioceptive Neuromuscular Facilitation Technique group; In addition to the exercises applied to the participants and the control group, combined isotonic contractions and dynamic stabilization will be used as facilitation techniques, and hold-relax technique will be used as an inhibition technique. **Name:** proprioceptive neuromuscular facilitation technique group **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - eccentric **Description:** Eccentric Muscle Training Technique: Participants will receive eccentric muscle training in addition to the exercises given to the control group. Before the application, 5-minute warm-up exercises will be given to the neck area. Eccentric muscle training will be applied to the muscles of the participants in the cervical region. Eccentric exercise will be strengthened in the cervical region muscles in the direction of movement in each plane, that is, flexion / extension and lateral flexion. The movements will first be explained and demonstrated to the patient. **Name:** eccentric muscle training technique application group **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Control **Description:** No intervention will be made. **Name:** Control **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Patients were asked to lie in a supine position with knees flexed at 90° and hands on the abdomen in a hook position. A 0.5 kilogram (kg) weight was placed on the forehead with the help of a band passed over the ears. The patients were asked to first perform cervical retraction and then 10° cervical flexion, and the degree of flexion was determined with the help of a goniometer. The patients were asked to maintain this position and the time was determined with a stopwatch and recorded in seconds. Patients must be able to maintain this position for 60 seconds (sec) in order to have sufficient muscle endurance. Those below this period have insufficient muscle endurance. Cervical flexion for 60 seconds. Patients holding it above were considered to have sufficient endurance and were not included in the study. **Measure:** Cervical Deep Flexor Muscle Endurance Test **Time Frame:** 8 weeks **Description:** The scale measures 28 general health, physical, psychological, social and environmental well-being and consists of 26 questions. Turkey version consists of 27 questions. The 27th question is the national question that determines the Environmental Score. Since each domain expresses the quality of life in its own field independently of each other, domain scores are calculated between 4-20. As the score increases, the quality of life increases. **Measure:** World Health Organization Quality of Life Survey Short Form **Time Frame:** 8 weeks **Description:** Neck Disability Index will be used to evaluate the disability specific to neck pain. The Neck Disability Index has been modified from the Oswestry Disability Index. It consists of 10 sections: pain intensity, personal care, weight bearing, reading, headache, concentration, working, driving, sleep and recreational activities. Each section consists of 6 answers and is scored from 0, no disability, to 5, representing total disability. According to total score; 0-4: no limitation, 5-14: mild limitation, 15-24: moderate limitation, 25-34: severe limitation, 34 and above: completely limited. **Measure:** Neck Disability Index **Time Frame:** 8 weeks **Description:** Tampa Kinesiophobia Scale was used to evaluate kinesiophobia, which is a state of anxiety that develops against activity and physical movement due to fear of pain and re-injury. It was developed to differentiate between non-excessive fear and phobia in patients with chronic musculoskeletal pain. It is frequently used in the literature to evaluate movement-related fear and anxiety. The scale is a 17-item scale that includes parameters of injury, re-injury and fear-avoidance in work-related activities. As the score increases, it is accepted that the kinesiophobia of the individual with pain increases.Results consist of a total raw score (range between 17 and 68) A low score indicates low kinesiophobia. **Measure:** Tampa Kinesiophobia Scale **Time Frame:** 8 weeks **Description:** Goniometric measurements in the neck are methods used to evaluate and record neck joint range of motion. These measurements are important to evaluate the patient's condition during the treatment process, follow the progress and create the treatment plan. **Measure:** Cervical joint goniometric measurements **Time Frame:** 8 weeks ### Eligibility Module **Eligibility Criteria:** INCLUSION CRITERIA * Being between the ages of 18-65 * History of neck pain that has persisted for at least 7 days * Agreeing to participate in the study * Having the ability to read and write Turkish. EXCLUSION CRITERIA * Radiculopathy and structural disorder in the cervical region, * Surgery to the cervical region, * Inflammatory disease, * Severe psychological illness, * Presence of infection in the bone and soft tissue in the cervical spine, * Malignancy, * Advanced osteoporosis, * Those with upper extremity pathologies, * Having a neurological disease that will prevent treatment * Having previously undergone cervical region and spine surgery * Having been included in a physiotherapy program for the neck and back area in the last 6 months, * It was defined as the administration of drugs such as NSAIDs (Nonsteroidal Anti-Inflammatory Drugs) and opioids in the last 24 hours. **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ömer ŞEVGİN **Phone:** +905069787535 **Role:** CONTACT #### Locations **Location 1:** **City:** Istanbul **Contacts:** ***Contact 1:*** - **Name:** Ömer ŞEVGİN - **Role:** CONTACT **Country:** Turkey **Facility:** Uskudar University **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Uskudar University **Name:** Büşra SÖKMEN YILDIRIM **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Holmgren T, Bjornsson Hallgren H, Oberg B, Adolfsson L, Johansson K. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. BMJ. 2012 Feb 20;344:e787. doi: 10.1136/bmj.e787. **PMID:** 22349588 **Citation:** Heredia-Rizo AM, Petersen KK, Madeleine P, Arendt-Nielsen L. Clinical Outcomes and Central Pain Mechanisms are Improved After Upper Trapezius Eccentric Training in Female Computer Users With Chronic Neck/Shoulder Pain. Clin J Pain. 2019 Jan;35(1):65-76. doi: 10.1097/AJP.0000000000000656. **PMID:** 30222615 **Citation:** Espi-Lopez GV, Aguilar-Rodriguez M, Zarzoso M, Serra-Ano P, Martinez DE LA Fuente JM, Ingles M, Marques-Sule E. Efficacy of a proprioceptive exercise program in patients with nonspecific neck pain: a randomized controlled trial. Eur J Phys Rehabil Med. 2021 Jun;57(3):397-405. doi: 10.23736/S1973-9087.20.06302-9. Epub 2020 Oct 13. **PMID:** 33047944 **Citation:** Hidalgo B, Hall T, Bossert J, Dugeny A, Cagnie B, Pitance L. The efficacy of manual therapy and exercise for treating non-specific neck pain: A systematic review. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1149-1169. doi: 10.3233/BMR-169615. **PMID:** 28826164 **Citation:** Gillani SN, Ain Q-, Rehman SU, Masood T. Effects of eccentric muscle energy technique versus static stretching exercises in the management of cervical dysfunction in upper cross syndrome: a randomized control trial. J Pak Med Assoc. 2020 Mar;70(3):394-398. doi: 10.5455/JPMA.300417. **PMID:** 32207413 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M29442 - Name: Chronic Pain - Relevance: HIGH - As Found: Chronic Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M21485 - Name: Neck Pain - Relevance: HIGH - As Found: Neck Pain - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000059350 - Term: Chronic Pain - ID: D000019547 - Term: Neck Pain ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00003079 **Brief Title:** Bryostatin 1 and High Dose Cytarabine in Treating Patients With Refractory or Relapsed Leukemia or Lymphoma **Official Title:** Phase I Study of Bryostatin 1 (NSC 339555) and High-Dose 1-Beta-D-Arabinofuranosylcytosine (HiDAC) in Patients With Refractory Leukemia #### Organization Study ID Info **ID:** CDR0000065773 #### Organization **Class:** OTHER **Full Name:** Virginia Commonwealth University #### Secondary ID Infos **ID:** P30CA016059 **Link:** https://reporter.nih.gov/quickSearch/P30CA016059 **Type:** NIH **ID:** MCV-MCC-9612-2E **ID:** NCI-T97-0011 ### Status Module #### Completion Date **Date:** 2001-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2010-02-17 **Type:** ESTIMATED **Last Update Submit Date:** 2010-02-15 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2001-05 **Type:** ACTUAL #### Start Date **Date:** 1997-09 **Status Verified Date:** 2010-02 #### Study First Post Date **Date:** 2004-05-27 **Type:** ESTIMATED **Study First Submit Date:** 2000-05-02 **Study First Submit QC Date:** 2004-05-26 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Cancer Institute (NCI) #### Lead Sponsor **Class:** OTHER **Name:** Virginia Commonwealth University #### Responsible Party **Old Name Title:** National Cancer Institute ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 and high dose cytarabine in treating patients with refractory or relapsed acute myelocytic or acute lymphocytic leukemia, chronic myelogenous leukemia or refractory or relapsed lymphoblastic lymphoma. **Detailed Description:** OBJECTIVES: I. Define the maximum tolerated dose (MTD) of bryostatin 1 administered before and after high dose cytarabine in patients with refractory or relapsed acute myelocytic leukemia or acute lymphocytic leukemia, chronic myelogenous leukemia, or refractory or relapsed lymphoblastic lymphoma. II. Describe the toxic effects of bryostatin 1 and high dose cytarabine in these patients. III. Describe the time course of bryostatin 1 induced modulation of leukemic blast total protein kinase C (PKC) activity. IV. Describe bryostatin 1 pharmacokinetics. V. Correlate bryostatin 1 induced modulation of leukemic cell PKC activity or leukemic cell maturation with high dose cytarabine mediated apoptosis. OUTLINE: This is a dose escalation study. Patients receive bryostatin 1 by continuous infusion over 24 hours on day 1. One hour after completion of bryostatin 1, patients receive high dose cytarabine IV over 3 hours every 12 hours on days 2-4. Patients again receive cytarabine over 3 hours every 12 hours on days 9-11, followed 1 hour later by bryostatin 1 by continuous infusion over 24 hours beginning on day 11. Patients achieving complete remission may receive up to 4 courses of consolidation chemotherapy. Consolidation chemotherapy is the same as induction chemotherapy except patients receive only 2 doses of cytarabine after day 1 completion of bryostatin and only 2 doses of cytarabine prior to the day 11 dose of bryostatin. Patients achieving partial remission may receive a second course of induction chemotherapy. In the absence of dose limiting toxicity in the first 3 patients treated, subsequent cohorts of 6 patients receive escalating doses of bryostatin 1 on the same schedule. If dose limiting toxicity occurs in 2 of 6 patients at a given dose level, then dose escalation ceases and the current dose is defined as the maximum tolerated dose. Patients are followed every 6 months until death. PROJECTED ACCRUAL: A total of 12-50 patients will be accrued for this study. ### Conditions Module **Conditions:** - Leukemia - Lymphoma **Keywords:** - recurrent adult acute myeloid leukemia - recurrent adult acute lymphoblastic leukemia - blastic phase chronic myelogenous leukemia - recurrent adult lymphoblastic lymphoma ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** FACTORIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** bryostatin 1 **Type:** DRUG #### Intervention 2 **Name:** cytarabine **Type:** DRUG ### Eligibility Module **Eligibility Criteria:** DISEASE CHARACTERISTICS: Histologically confirmed primary refractory or relapsed acute myelocytic leukemia (AML) or acute lymphocytic leukemia (ALL), chronic myelogenous leukemia (CML) in blast crisis, or refractory or relapsed lymphoblastic lymphoma Priority is given to patients previously treated with conventional high dose cytarabine regimen without bryostatin 1 Eligible if previously failed a conventional high dose cytarabine regimen or if underwent subsequent high dose therapy with bone marrow/stem cell transplantation with curative intent PATIENT CHARACTERISTICS: Age: 18 and over (must be 60 or under if receiving higher dose of cytarabine) Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL (bilirubin no greater than 3.0 mg/dL and conjugated bilirubin no greater than 0.5 mg/dL if Gilbert's disease and predominantly unconjugated hyperbilirubinemia present) AST no greater than 2.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine clearance at least 40 mL/min (at least 60 mL/min if receiving higher dose of cytarabine) Pulmonary: No clinically significant pulmonary disease Other: Not pregnant No patients who are poor medical risks because of nonmalignant systemic disease No serious, active, uncontrolled infection No prior or concurrent medical status that would make assessing cortical or cerebellar neurologic toxicity difficult PRIOR CONCURRENT THERAPY: Recovery from the major toxic effects of prior therapy required Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 24 hours since prior chemotherapy with hydroxyurea At least 3 weeks since other prior systemic chemotherapy No prior clinically significant cerebellar toxicity due to cytarabine Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** New York **Country:** United States **Facility:** New York Presbyterian Hospital - Cornell Campus **State:** New York **Zip:** 10021 **Location 2:** **City:** Houston **Country:** United States **Facility:** University of Texas - MD Anderson Cancer Center **State:** Texas **Zip:** 77030 **Location 3:** **City:** Richmond **Country:** United States **Facility:** Massey Cancer Center **State:** Virginia **Zip:** 23298-0037 #### Overall Officials **Official 1:** **Affiliation:** Massey Cancer Center **Name:** Steven Grant, MD **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000008206 - Term: Lymphatic Diseases - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases - ID: D000006402 - Term: Hematologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10945 - Name: Leukemia - Relevance: HIGH - As Found: Leukemia - ID: M10955 - Name: Leukemia, Myeloid - Relevance: LOW - As Found: Unknown - ID: M18127 - Name: Leukemia, Myeloid, Acute - Relevance: LOW - As Found: Unknown - ID: M10951 - Name: Leukemia, Lymphoid - Relevance: LOW - As Found: Unknown - ID: M18123 - Name: Leukemia, Myelogenous, Chronic, BCR-ABL Positive - Relevance: LOW - As Found: Unknown - ID: M27585 - Name: Precursor Cell Lymphoblastic Leukemia-Lymphoma - Relevance: LOW - As Found: Unknown - ID: M11220 - Name: Lymphoma - Relevance: HIGH - As Found: Lymphoma - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M5033 - Name: Blast Crisis - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: T3995 - Name: Myeloid Leukemia - Relevance: LOW - As Found: Unknown - ID: T182 - Name: Acute Myeloid Leukemia - Relevance: LOW - As Found: Unknown - ID: T188 - Name: Acute Non Lymphoblastic Leukemia - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T1309 - Name: Chronic Myeloid Leukemia - Relevance: LOW - As Found: Unknown - ID: T175 - Name: Acute Lymphoblastic Leukemia - Relevance: LOW - As Found: Unknown - ID: T3533 - Name: Lymphoblastic Lymphoma - Relevance: LOW - As Found: Unknown - ID: T3543 - Name: Lymphosarcoma - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008223 - Term: Lymphoma - ID: D000007938 - Term: Leukemia ### Intervention Browse Module - Ancestors - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents - ID: D000000998 - Term: Antiviral Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000276 - Term: Adjuvants, Immunologic ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M6766 - Name: Cytarabine - Relevance: HIGH - As Found: Infants - ID: M211115 - Name: Bryostatin 1 - Relevance: HIGH - As Found: Tretinoin - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown - ID: M4314 - Name: Antiviral Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M3628 - Name: Adjuvants, Immunologic - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000003561 - Term: Cytarabine - ID: C000046785 - Term: Bryostatin 1 ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02594579 **Brief Title:** Effect of Vitamin D3 Supplementation on Muscle Mass in ICU Patient **Official Title:** Effect of High Dose Vitamin D3 Supplementation on Skeletal Muscle Mass and Body Compositions in Critically Ill Patients With Vitamin D Deficiency #### Organization Study ID Info **ID:** 075802 #### Organization **Class:** OTHER **Full Name:** Mahidol University ### Status Module #### Completion Date **Date:** 2016-12 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** NOT_YET_RECRUITING #### Last Update Post Date **Date:** 2015-11-03 **Type:** ESTIMATED **Last Update Submit Date:** 2015-10-30 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2016-12 **Type:** ESTIMATED #### Start Date **Date:** 2015-10 **Status Verified Date:** 2015-10 #### Study First Post Date **Date:** 2015-11-03 **Type:** ESTIMATED **Study First Submit Date:** 2015-10-05 **Study First Submit QC Date:** 2015-10-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mahidol University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** A randomized double blind placebo control trial study will be conducted in critically ill patients with vitamin D deficiency. Investigator aimed to study the effect of oral vitamin D3 supplementation, compare to placebo, on skeletal muscle mass and body composition. **Detailed Description:** There is a high prevalence of vitamin D deficiency in critically ill patient which is associated with muscle wasting and physical disability. Recent study showed that treatment of vitamin D deficiency with high dose vitamin D improved muscle wasting and may prevent further muscle breakdown. Investigator want to explore whether a high dose vitamin D3 supplementation, compare to placebo will be able to improve muscle wasting in critically ill patients. The eligible participant will be asked to sign and date the informed consent document then they will be randomized to receive vitamin D3 supplement or placebo, using the computer generated code in conceal envelope. Vitamin D3 or placebo will be given orally or feeding tube via feeding tube at a dose of 100,000 IU on day 1 and 3 then 50,000 IU on day 5,7,9,12 followed by 150,000 unit per week for 4 week. Serum 25-Hydroxyvitamin D, 1,25-dihydroxyvitamin D will be measured at baseline (day 0) then day 10 and day 43 after vitamin D supplementation. Moreover, Investigator will assess the diameter of rectus femoris by using ultrasonography on day 0,10 and 43. ### Conditions Module **Conditions:** - Vitamin D Deficiency - Sarcopenia - Critical Illness ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Dietary Supplement: Vitamin D3 **Intervention Names:** - Drug: Vitamin D3 **Label:** Vitamin D **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Dietary Supplement: Placebo **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Vitamin D **Description:** Vitamin D3 100,000 u per day on day 1,3 then 50,000 u/day on day 5,7,9,12 and continue 50,000 u 3 times/ week for 4 weeks **Name:** Vitamin D3 **Other Names:** - Cholecalciferol (D3-50) **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Placebo on day 1,3,5,7,9,12 then 3 times/ week for 4 weeks **Name:** Placebo **Other Names:** - Cholecalciferol (D3-50) placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** A difference of change from baseline Rectus femoris cross-sectional diameter at day 43 in participant who receive cholecalciferol or placebo **Measure:** Rectus femoris cross-sectional diameer **Time Frame:** Change from baseline Rectus femoris cross-sectional diameter at day 43 #### Secondary Outcomes **Description:** Participant will be followed for the duration of hospital stay **Measure:** Length of hospital stays **Time Frame:** An expected average of 3 weeks **Description:** Participant will be followed for the duration of ICU stay **Measure:** Length of ICU stays **Time Frame:** An expected average of 2 weeks **Description:** Percentage of skeletal muscle mass will be assessed using bioelectrical impedance analysis **Measure:** Percentage of skeletal muscle mass **Time Frame:** Change from basline percentage skeletal muscle mass at day 43 **Description:** Number percentage of participant who above 25(OH)D concentration above or equal 30 in participant who receive cholecalciferol or placebo **Measure:** Correction vitamin D deficiency **Time Frame:** 43 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 18 - 70 years old * Expected ICU stay ≥ 48 hrs Exclusion Criteria: * Participate in other clinical trial * Contraindication to receive oral or enteral feeding * Do not resuscitate /imminent death * Vegetative state, generalize weakness, denervation of leg, both leg amputation * Hypercalcemia or Hypercalcemia at risk * Hyperphosphatemia, * History of nephrolithiasis * End stage renal disease on renal replacement therapy * Pregnancy/lactation * Consent refusal **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Daruneewan Warodomwichit **Phone:** (662)2011000 **Phone Ext:** 0082 **Role:** CONTACT #### Locations **Location 1:** **City:** Bangkok **Contacts:** ***Contact 1:*** - **Name:** Daruneewan Warodomwichit - **Role:** CONTACT ***Contact 2:*** - **Name:** Daruneewan Warodomwichit, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Praopilad Srisuwarn, MD - **Role:** SUB_INVESTIGATOR **Country:** Thailand **Facility:** Department of Medicine, Faculty of medicine, Ramathibodi Hospital **Zip:** 10400 #### Overall Officials **Official 1:** **Affiliation:** Division of Nutrition and Biochemical medicine, Department of Medicine, Faculty of medicine, Ramathibodi Hospital, Mahidol University Bangkok, Thailand **Name:** Daruneewan Warodomwichit **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009133 - Term: Muscular Atrophy - ID: D000020879 - Term: Neuromuscular Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000001284 - Term: Atrophy - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000001361 - Term: Avitaminosis - ID: D000003677 - Term: Deficiency Diseases - ID: D000044342 - Term: Malnutrition - ID: D000009748 - Term: Nutrition Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M19010 - Name: Critical Illness - Relevance: HIGH - As Found: Critical Illness - ID: M28396 - Name: Sarcopenia - Relevance: HIGH - As Found: Sarcopenia - ID: M17551 - Name: Vitamin D Deficiency - Relevance: HIGH - As Found: Vitamin D Deficiency - ID: M12090 - Name: Muscular Atrophy - Relevance: LOW - As Found: Unknown - ID: M4589 - Name: Atrophy - Relevance: LOW - As Found: Unknown - ID: M22619 - Name: Neuromuscular Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M4660 - Name: Avitaminosis - Relevance: LOW - As Found: Unknown - ID: M6879 - Name: Deficiency Diseases - Relevance: LOW - As Found: Unknown - ID: M25306 - Name: Malnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000055948 - Term: Sarcopenia - ID: D000014808 - Term: Vitamin D Deficiency - ID: D000016638 - Term: Critical Illness ### Intervention Browse Module - Ancestors - ID: D000014815 - Term: Vitamins - ID: D000018977 - Term: Micronutrients - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000050071 - Term: Bone Density Conservation Agents - ID: D000077264 - Term: Calcium-Regulating Hormones and Agents ### Intervention Browse Module - Browse Branches - Abbrev: BDCA - Name: Bone Density Conservation Agents - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M17550 - Name: Vitamin D - Relevance: HIGH - As Found: 2.5 - ID: M6003 - Name: Cholecalciferol - Relevance: HIGH - As Found: 2.5 - ID: M17558 - Name: Vitamins - Relevance: LOW - As Found: Unknown - ID: M21009 - Name: Micronutrients - Relevance: LOW - As Found: Unknown - ID: M16885 - Name: Trace Elements - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M5381 - Name: Calcium - Relevance: LOW - As Found: Unknown - ID: M5398 - Name: Calcium, Dietary - Relevance: LOW - As Found: Unknown - ID: T442 - Name: Cholecalciferol - Relevance: HIGH - As Found: 2.5 - ID: T479 - Name: Vitamin D3 - Relevance: HIGH - As Found: 2.5 - ID: T440 - Name: Calciferol - Relevance: HIGH - As Found: 2.5 ### Intervention Browse Module - Meshes - ID: D000014807 - Term: Vitamin D - ID: D000002762 - Term: Cholecalciferol ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01082679 **Brief Title:** Treatment for Opioid Dependent Offenders **Official Title:** Treatment for Opioid Dependent Offenders #### Organization Study ID Info **ID:** H-2008-0242 #### Organization **Class:** OTHER **Full Name:** University of Wisconsin, Madison ### Status Module #### Completion Date **Date:** 2011-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-06-05 **Type:** ACTUAL **Last Update Submit Date:** 2023-06-02 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2011-03 **Type:** ACTUAL #### Start Date **Date:** 2009-06 **Status Verified Date:** 2019-05 #### Study First Post Date **Date:** 2010-03-08 **Type:** ESTIMATED **Study First Submit Date:** 2010-03-05 **Study First Submit QC Date:** 2010-03-05 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Wisconsin, Milwaukee #### Lead Sponsor **Class:** OTHER **Name:** University of Wisconsin, Madison #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This pilot study is examining the feasibility of a primary care and a specialist treatment (methadone clinic) model of treatment for 15 offenders who are part of two community supervision programs: Drug Court and the Treatment Alternative Program (TAP) in Dane County. The questions addressed by future larger studies based upon the current pilot-feasibility study will center around whether access to primary health care as opposed to more traditional methadone treatment services will improve the health and criminal justice outcomes for participants. ### Conditions Module **Conditions:** - Opioid Dependence **Keywords:** - opioid dependent - methadone - Suboxone - buprenorphine ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 16 **Type:** ACTUAL **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Methadone **Label:** methadone via specialty care **Type:** OTHER #### Arm Group 2 **Intervention Names:** - Drug: buprenorphine (Suboxone) **Label:** Suboxone via specialty care **Type:** OTHER #### Arm Group 3 **Intervention Names:** - Drug: buprenorphine (Suboxone) **Label:** Suboxone via primary care **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - methadone via specialty care **Description:** daily for 12 months **Name:** Methadone **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Suboxone via primary care - Suboxone via specialty care **Description:** daily for 12 months **Name:** buprenorphine (Suboxone) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** This study is focused on Dane County Drug Treatment Court and Treatment Alternative Program participants. The study will determine feasibility of monitoring participants in primary care as opposed to the usual standard of specialty care. Feasibility of monitoring participants will be studied in terms of retention rate of participants in the study **Measure:** Retention rate of participants in the study **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * diagnosis of opioid dependence * opioid positive urine drug screen * participation in local Drug Treatment Court or Treatment Alternative Program * women of childbearing potential who have a negative screening urine pregnancy test and are willing to use appropriate birth control methods during the duration of the study Exclusion Criteria: * current alcohol or sedative dependence * pregnancy * women who are currently breast-feeding * complex psychiatric co-morbidity (e.g. suicidality, psychosis) * complex medical co-morbidity (e.g. major cardiovascular, renal, or gastrointestinal/hepatic disease) * current pharmacotherapy with an agent which is contraindicated in combination with Suboxone or methadone according to drug labeling * paralytic ileus, coronary artery disease or heart arrhythmia, recent head injury, obstructive sleep apnea, severe asthma or COPD, end-stage renal disease, or severe morbid obesity **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Madison **Country:** United States **Facility:** University of Wisconsin - Madison **State:** Wisconsin **Zip:** 53715 #### Overall Officials **Official 1:** **Affiliation:** University of Wisconsin - Madison, Department of Family Medicine **Name:** Randy Brown, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Brown R, Gassman M, Hetzel S, Berger L. Community-based treatment for opioid dependent offenders: a pilot study. Am J Addict. 2013 Sep-Oct;22(5):500-2. doi: 10.1111/j.1521-0391.2013.12049.x. Epub 2013 Apr 3. **PMID:** 23952897 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000079524 - Term: Narcotic-Related Disorders - ID: D000019966 - Term: Substance-Related Disorders - ID: D000064419 - Term: Chemically-Induced Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC25 - Name: Substance Related Disorders - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12244 - Name: Opioid-Related Disorders - Relevance: HIGH - As Found: Opioid Dependence - ID: M2057 - Name: Narcotic-Related Disorders - Relevance: LOW - As Found: Unknown - ID: M21837 - Name: Substance-Related Disorders - Relevance: LOW - As Found: Unknown - ID: M30302 - Name: Chemically-Induced Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009293 - Term: Opioid-Related Disorders ### Intervention Browse Module - Ancestors - ID: D000000701 - Term: Analgesics, Opioid - ID: D000009294 - Term: Narcotics - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000700 - Term: Analgesics - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000009292 - Term: Narcotic Antagonists - ID: D000000996 - Term: Antitussive Agents - ID: D000019141 - Term: Respiratory System Agents ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: NarcAntag - Name: Narcotic Antagonists - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AnTuAg - Name: Antitussive Agents - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: AnObAg - Name: Anti-Obesity Agents - Abbrev: VaCoAg - Name: Vasoconstrictor Agents ### Intervention Browse Module - Browse Leaves - ID: M5317 - Name: Buprenorphine - Relevance: HIGH - As Found: Aortic - ID: M11671 - Name: Methadone - Relevance: HIGH - As Found: Of Children - ID: M447 - Name: Buprenorphine, Naloxone Drug Combination - Relevance: HIGH - As Found: Sling - ID: M4033 - Name: Analgesics, Opioid - Relevance: LOW - As Found: Unknown - ID: M12221 - Name: Naloxone - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M12245 - Name: Narcotics - Relevance: LOW - As Found: Unknown - ID: M12243 - Name: Narcotic Antagonists - Relevance: LOW - As Found: Unknown - ID: M13570 - Name: Phenylpropanolamine - Relevance: LOW - As Found: Unknown - ID: M9238 - Name: Guaifenesin - Relevance: LOW - As Found: Unknown - ID: M186319 - Name: Chlorpheniramine, phenylpropanolamine drug combination - Relevance: LOW - As Found: Unknown - ID: M4312 - Name: Antitussive Agents - Relevance: LOW - As Found: Unknown - ID: M21137 - Name: Respiratory System Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000002047 - Term: Buprenorphine - ID: D000008691 - Term: Methadone - ID: D000069479 - Term: Buprenorphine, Naloxone Drug Combination ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02303379 **Brief Title:** Different Endurance Training Protocols in Cardiac Patients **Official Title:** Effects of Different Endurance Training Protocols on Physical Performance in Cardiac Patients #### Organization Study ID Info **ID:** UISM-8 #### Organization **Class:** OTHER **Full Name:** Paracelsus Medical University ### Status Module #### Completion Date **Date:** 2020-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-01-29 **Type:** ACTUAL **Last Update Submit Date:** 2021-01-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2018-12 **Type:** ACTUAL #### Start Date **Date:** 2014-01 **Status Verified Date:** 2021-01 #### Study First Post Date **Date:** 2014-11-27 **Type:** ESTIMATED **Study First Submit Date:** 2014-11-25 **Study First Submit QC Date:** 2014-11-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Paracelsus Medical University #### Responsible Party **Investigator Affiliation:** Paracelsus Medical University **Investigator Full Name:** Prof. Josef Niebauer M.D., Ph.D., MBA **Investigator Title:** Head of institute **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** It is the aim of our study to compare the effects of 6 and/or 2 years of either HIT (carried out at correctly assessed 85-95% of maximal heart rate), pyramid, or continuous endurance training, on changes of physical exercise capacity in cardiac patients. **Detailed Description:** The three exercise arms (isocaloric) are composed as follows: Endurance training: 31 min at 65-75% HRmax, making it a total of 25min; HIT: 4x4min intervals at 85-95% HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25 min; Pyramid: One pyramid consists of 8 one-minute blocks. Those are grouped starting with one block of 70-75% HRmax, followed by one block at 75-80% HRmax and another one at 80-85% HRmax. The top of the pyramid are 2 blocks of 85-90% HRmax. Intensity is lowered afterwards with one block of 80-85% HRmax, followed by one block at 75-80% HRmax and last one at 70-75% HRmax. Two more pyramids follow, each divided by 2min of active recovery at 65-70% HRmax, making it a total of 28min. All protocols are initiated by 5min of warm-up and end with 5min of cool-down, both at 60-70% HRmax. Primary Outcome: Individual maximum power output in watt (Pmax). Secondary Outcome: Change of power output in watt at lactate tresholds at 2 and 4mmol/l. ### Conditions Module **Conditions:** - Coronary Artery Disease **Keywords:** - Training Protocol - Cardiac Rehabilitation - High-Intensity Interval Training - Continuous Training - Pyramid Training - Physical Performance ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 52 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Endurance training with constant work load 31min at 65-75% maximal heart rate (HRmax) **Intervention Names:** - Other: Pyramid Training - Other: High-intensity interval training **Label:** Continuous Endurance training **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** One pyramid consists of 8 one-minute blocks. Those are grouped starting with one block of 70-75% HRmax, followed by one block at 75-80% HRmax and another one at 80-85% HRmax. The top of the pyramid are 2 blocks of 85-90% HRmax. Intensity is lowered afterwards with one block of 80-85% HRmax, followed by one block at 75-80% HRmax and last one at 70-75% HRmax. Two more pyramids follow, each divided by 2min of active recovery at 65-70% HRmax, making it a total of 28min. **Intervention Names:** - Other: Continuous Endurance Training - Other: High-intensity interval training **Label:** Pyramid Training **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** HIT: 4x4 min intervals at85-95% HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25min. **Intervention Names:** - Other: Continuous Endurance Training - Other: Pyramid Training **Label:** High-intensity intervall training **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - High-intensity intervall training - Pyramid Training **Description:** Endurance training with constant work load 31min at 65-75% Hrmax **Name:** Continuous Endurance Training **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Continuous Endurance training - High-intensity intervall training **Description:** One pyramid consists of 8 one-minute blocks. Those are grouped starting with one block of 70-75% HRmax, followed by one block at 75-80% HRmax and another one at 80-85% HRmax. The top of the pyramid are 2 blocks of 85-90% HRmax. Intensity is lowered afterwards with one block of 80-85% HRmax, followed by one block at 75-80% HRmax and last one at 70-75% HRmax. Two more pyramids follow, each divided by 2min of active recovery at 65-70% HRmax, making it a total of 28min. **Name:** Pyramid Training **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Continuous Endurance training - Pyramid Training **Description:** HIT: 4x4 min intervals at85-95% HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25min. **Name:** High-intensity interval training **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** PWC will be measured by graded exercise testing on cycle ergometer. **Measure:** Physical work capacity (PWC) **Time Frame:** 6 weeks or 36 weeks #### Secondary Outcomes **Description:** Heart rate will be measured by graded exercise testing on cycle ergometer. **Measure:** Heart rate **Time Frame:** 6 weeks or 36 weeks **Description:** Blood pressure will be measured by graded exercise testing on cycle ergometer. **Measure:** Blood pressure **Time Frame:** 6 weeks or 36 weeks **Description:** Lactate thresholds will be measured by graded exercise testing on cycle ergometer. **Measure:** Lactate Thresholds **Time Frame:** 6 weeks or 36 weeks **Description:** Blood will be taken before and after intervention **Measure:** Metabolical and cellular blood parameter **Time Frame:** 6 weeks or 36 weeks **Description:** BMI will be taken before and after intervention **Measure:** BMI **Time Frame:** 6 weeks or 36 weeks **Description:** Gene expression will be taken before and after intervention **Measure:** Gene expression **Time Frame:** 6 weeks or 36 weeks **Description:** Quality of Life will be taken before and after intervention **Measure:** Quality of Life **Time Frame:** 6 weeks or 36 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * acute coronary syndrome (STEMI - NONSTEMI) * aortocoronary bypass surgery * percutaneous coronary intervention (PCI) * state after stable coronary heart disease * state after heart surgeries * state after myo-, endo-, or pericarditis * state after heart- or lung-transplantation * state after heart failure * state after pulmonary hypertension * state after peripheral venous disease * state after electrophysiological surgery * state after implantation of an implantable cardioverter or difibrillator * Patients at high risk * Patients with cardiac dysrhythmias or sudden death Exclusion Criteria: * unstable angina pectoris * Heart failure (NYHA IV) * acute myo-, endo-, or pericarditis or other infections * pulmonary-arterial embolism or phlebothrombosis within 6 months * hemodynamic instable dysrhythmias * hypertrophic cardiomyopathy * medical conditions which prevent patients from complying with the exercise program **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Salzburg **Country:** Austria **Facility:** Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University **Zip:** 5020 #### Overall Officials **Official 1:** **Affiliation:** Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University **Name:** Prof. Josef Niebauer, M.D, PhD,MBA **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Mayr B, Muller EE, Schafer C, Droese S, Schonfelder M, Niebauer J. Exercise-induced changes in miRNA expression in coronary artery disease. Clin Chem Lab Med. 2021 May 12;59(10):1719-1727. doi: 10.1515/cclm-2021-0164. Print 2021 Sep 27. **PMID:** 33977686 #### See Also Links **Label:** Paracelsus Medical University Salzburg, Austria **URL:** http://www.pmu.ac.at **Label:** Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University **URL:** http://www.salk.at/sportmedizin.html **Label:** Salzburg Regional Hospital **URL:** http://www.salk.at/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003327 - Term: Coronary Disease - ID: D000017202 - Term: Myocardial Ischemia - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000001161 - Term: Arteriosclerosis - ID: D000001157 - Term: Arterial Occlusive Diseases - ID: D000014652 - Term: Vascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M6549 - Name: Coronary Disease - Relevance: LOW - As Found: Unknown - ID: M6546 - Name: Coronary Artery Disease - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M4469 - Name: Arteriosclerosis - Relevance: LOW - As Found: Unknown - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003324 - Term: Coronary Artery Disease ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02363179 **Acronym:** MUES **Brief Title:** Music in the Emergency Department (ED): Phase II **Official Title:** Music in Urgent and Emergent Settings (MUES) Trial: Phase Two #### Organization Study ID Info **ID:** IRB201500083 #### Organization **Class:** OTHER **Full Name:** University of Florida #### Secondary ID Infos **Domain:** FL DEPT OF STATE DIV OF CULTURAL AFFAIRS **ID:** 15-8503 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2017-06 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-07-06 **Type:** ACTUAL **Last Update Submit Date:** 2017-07-03 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-06 **Type:** ACTUAL #### Start Date **Date:** 2015-05 **Type:** ACTUAL **Status Verified Date:** 2017-07 #### Study First Post Date **Date:** 2015-02-13 **Type:** ESTIMATED **Study First Submit Date:** 2015-02-09 **Study First Submit QC Date:** 2015-02-09 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Florida Department of State Division Of Cultural Affairs **Class:** FED **Name:** National Endowment for the Arts, United States #### Lead Sponsor **Class:** OTHER **Name:** University of Florida #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The investigators will conduct a prospective quasi-experimental design study of patients in the University of Florida Health Emergency Department. Live preferential music will be performed for patients in the emergency department on alternating days over 20 weeks, and subjects exposed to the music intervention will be matched to a cohort that present to the emergency department on days with no music to assess impact on patient and healthcare provider satisfaction, pain medication utilization, length of stay, and cost of care. **Detailed Description:** Every year, over 130 million patients access emergency care in the US. Emergency Departments are high stress environments and are one of the significant drivers of high costs in healthcare. The prevalence of anxiety experienced by patients in the emergency department (ED) is abundant and substantial. Anxiety negatively affects the patient, the ED healthcare environment, and ED healthcare staff. Additionally, anxiety routinely results in the administration of medication that would be otherwise unnecessary, and contributes to the overall cost of healthcare and the stress of clinicians, particularly nursing staff. The University of Florida (UF) Department of Emergency Medicine, in partnership with the UF Center for Arts in Medicine, has recently completed phase one, and is proposing phase two, of a three-phase study to assess the impact of live preferential music on emergency department operations, including pain medication utilization and cost of care. The investigators propose to expand on the phase one pilot study to conduct a full randomized controlled study utilizing a group of highly talented musicians to provide live preferential music in our ED and level one trauma center setting. The project, the first systematic investigation of its kind, seeks to demonstrate that live preferential music in an emergency and trauma care setting can positively impact quality and cost of care. ### Conditions Module **Conditions:** - Music Therapy - Patient Satisfaction **Keywords:** - Emergency Service, Hospital ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 1107 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 500 non-intervention patients will be consented to serve as the control group **Label:** Non Music Group **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** 500 intervention patients will be consented to participate in the live preferential music intervention **Intervention Names:** - Behavioral: Live preferential music **Label:** Music Intervention Group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Music Intervention Group **Description:** Live preferential music will be performed for patients in the emergency department. **Name:** Live preferential music **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Pain Medication Usage **Measure:** Pain Medication Utilization **Time Frame:** 20 weeks #### Secondary Outcomes **Description:** Assessment of the chart associated cost per patient **Measure:** Cost of Care **Time Frame:** 20 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Language: english * Cognitive skill/education: grade 2 reading level or above Exclusion Criteria: * Language: Non-english speaking * Age: Less than 18 * Cognitive skill/education: lower than grade 2 reading level **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Gainesville **Country:** United States **Facility:** UF Health **State:** Florida **Zip:** 32608 #### Overall Officials **Official 1:** **Affiliation:** University of Florida **Name:** Joseph A Tyndall, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Rothrock SG, Johnson NE. Pain management in the pediatric emergency department. Pediatr Emerg Care. 1989 Dec;5(4):298. No abstract available. **PMID:** 2602211 **Citation:** Bengtsson SL, Ullen F, Ehrsson HH, Hashimoto T, Kito T, Naito E, Forssberg H, Sadato N. Listening to rhythms activates motor and premotor cortices. Cortex. 2009 Jan;45(1):62-71. doi: 10.1016/j.cortex.2008.07.002. Epub 2008 Oct 30. **PMID:** 19041965 **Citation:** Gallagher LM. The role of music therapy in palliative medicine and supportive care. Semin Oncol. 2011 Jun;38(3):403-6. doi: 10.1053/j.seminoncol.2011.03.010. **PMID:** 21600370 **Citation:** Good M. A comparison of the effects of jaw relaxation and music on postoperative pain. Nurs Res. 1995 Jan-Feb;44(1):52-7. **PMID:** 7862546 **Citation:** Good M, Stanton-Hicks M, Grass JA, Anderson GC, Lai HL, Roykulcharoen V, Adler PA. Relaxation and music to reduce postsurgical pain. J Adv Nurs. 2001 Jan;33(2):208-15. doi: 10.1046/j.1365-2648.2001.01655.x. **PMID:** 11168704 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7796 - Name: Emergencies - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01558479 **Acronym:** PaGeR **Brief Title:** The Parkinson's Genetic Research Study **Official Title:** The Parkinson's Genetic Research Study (PaGeR) #### Organization Study ID Info **ID:** 36777 #### Organization **Class:** OTHER **Full Name:** University of Washington ### Status Module #### Completion Date **Date:** 2026-10-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-11 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-10-31 **Type:** ESTIMATED #### Start Date **Date:** 2009-09 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2012-03-20 **Type:** ESTIMATED **Study First Submit Date:** 2012-03-16 **Study First Submit QC Date:** 2012-03-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Washington #### Responsible Party **Investigator Affiliation:** University of Washington **Investigator Full Name:** Cyrus Zabetian **Investigator Title:** Professor of Neurology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The Parkinson's Genetic Research Study (PaGeR), headed by Dr. Cyrus Zabetian, is searching for genes that increase the risk of developing Parkinson's disease (PD) and related disorders. The study is a joint effort by neurologists and researchers across the United States and is sponsored by the National Institutes of Health. The coordinating center for PaGeR is located at the University of Washington and the VA Puget Sound Health Care System in Seattle. **Detailed Description:** PaGeR is focusing on families in which two or more people have been diagnosed with PD. Past research suggests that such "multiplex" families might hold the key to the discovery of new PD genes. To take part in PaGeR, participants will be asked to complete a questionnaire and to undergo an interview, a neurological exam, a short memory test, and a blood draw. Enrollment in the study usually takes between one and two hours. There is no cost to participate, and all study information is kept strictly confidential. There are a number of designated sites across the country where families can enroll. However, for family members who are unable to travel to one of these sites, other arrangements can be made. ### Conditions Module **Conditions:** - Parkinson's Disease **Keywords:** - Parkinson's Disease - Genetics - Family Research - Hereditary Neurodegenerative Diseases ### Design Module #### Bio Spec **Description:** Blood or saliva **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** FAMILY_BASED **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 5000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Has a diagnosis of Parkinson's disease **Label:** Case #### Arm Group 2 **Description:** No diagnosis of Parkinson's disease **Label:** Control #### Arm Group 3 **Description:** Has a family history of Parkinson's disease. Can be affected or unaffected with Parkinson's disease **Label:** Family Member ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Over 18 years of age * Member of a family in which there are two or more living individuals who have been diagnosed with Parkinson's disease Exclusion Criteria: * Under 18 years of age **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Families in which two or more people have been diagnosed with Parkinson's disease. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Name:** Jennifer Pate **Phone:** 1-855-646-4221 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Khryss Capawa **Phone:** (206) 277-3956 **Role:** CONTACT #### Locations **Location 1:** **City:** Atlanta **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Barbara Sommerfield, MSN, RN - **Phone:** 404-728-6944 - **Role:** CONTACT **Country:** United States **Facility:** Emory University/ Wesley Woods Health Center **State:** Georgia **Status:** RECRUITING **Zip:** 30329 **Location 2:** **City:** Cincinnati **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jatue Krier - **Phone:** 513-558-0169 - **Role:** CONTACT **Country:** United States **Facility:** University of Cincinnati **State:** Ohio **Status:** RECRUITING **Zip:** 45267 **Location 3:** **City:** Portland **Contacts:** ***Contact 1:*** - **Name:** Susan O'Connor - **Phone:** 503-220-8262 - **Phone Ext:** 53262 - **Role:** CONTACT **Country:** United States **Facility:** Portland VA Medical Center **State:** Oregon **Status:** RECRUITING **Zip:** 97239 **Location 4:** **City:** Seattle **Contacts:** ***Contact 1:*** - **Name:** Jennifer Pate - **Phone:** 855-646-4221 - **Role:** CONTACT ***Contact 2:*** - **Name:** Cyrus Zabetian, MD, MS - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** VA Puget Sound Health Care System **State:** Washington **Status:** RECRUITING **Zip:** 98108 **Location 5:** **City:** Seattle **Contacts:** ***Contact 1:*** - **Name:** Jennifer Pate - **Phone:** 855-646-4221 - **Role:** CONTACT ***Contact 2:*** - **Name:** Cyrus Zabetian, MD, MS - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of Washington **State:** Washington **Status:** RECRUITING **Zip:** 98118 #### Overall Officials **Official 1:** **Affiliation:** University of Washington, VA Puget Sound Health Care System **Name:** Cyrus Zabetian, MD, MS **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### See Also Links **Label:** Study Website **URL:** http://www.thepagerstudy.org ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020734 - Term: Parkinsonian Disorders - ID: D000001480 - Term: Basal Ganglia Diseases - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009069 - Term: Movement Disorders - ID: D000080874 - Term: Synucleinopathies - ID: D000019636 - Term: Neurodegenerative Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M13213 - Name: Parkinson Disease - Relevance: HIGH - As Found: Parkinson's - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M22092 - Name: Heredodegenerative Disorders, Nervous System - Relevance: LOW - As Found: Unknown - ID: M22494 - Name: Parkinsonian Disorders - Relevance: LOW - As Found: Unknown - ID: M25603 - Name: Ganglion Cysts - Relevance: LOW - As Found: Unknown - ID: M16358 - Name: Synovial Cyst - Relevance: LOW - As Found: Unknown - ID: M4774 - Name: Basal Ganglia Diseases - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12029 - Name: Movement Disorders - Relevance: LOW - As Found: Unknown - ID: M2217 - Name: Synucleinopathies - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010300 - Term: Parkinson Disease ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01212679 **Brief Title:** Effects of Intranasal Nerve Growth Factor for Traumatic Brain Injury **Official Title:** Pilot Study of Intranasal Nerve Growth Factor for Traumatic Brain Injury(TBI) #### Organization Study ID Info **ID:** NGF-TBI #### Organization **Class:** OTHER **Full Name:** Jinling Hospital, China ### Status Module #### Completion Date **Date:** 2017-10 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-11-01 **Type:** ACTUAL **Last Update Submit Date:** 2017-10-30 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-10 **Type:** ACTUAL #### Start Date **Date:** 2010-12 **Status Verified Date:** 2016-11 #### Study First Post Date **Date:** 2010-10-01 **Type:** ESTIMATED **Study First Submit Date:** 2010-09-30 **Study First Submit QC Date:** 2010-09-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Jinling Hospital, China #### Responsible Party **Investigator Affiliation:** Jinling Hospital, China **Investigator Full Name:** Xinfeng Liu **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** Traumatic bain injury(TBI) remains a hidden epidemic involving individuals affected predominantly at a young age who in the most severe cases remain with permanent physical,psychological and cognitive deficits.This study will investigate the therapeutic effects of intranasal Nerve Growth Factor(NGF) in TBI. **Detailed Description:** Early NGF concentration in the cerebral spinal fluid(CSF)correlates significantly with the severity of head injury, and NGF upregulation correlates with better neurologic outcomes and could be useful to obtain clinical and prognostic information in patients with serve TBI. However, the clinical use of NGF is difficulty associated with delivering them to the CNS because of the existing of blood-brain barrier(BBB). Intranasal delivery drug is a noninvasive and convenient novel method bypassing BBB, which results in targeting therapeutics to the CNS rapidly. The proposed study is a randomized, double-blind, placebo-controlled trail of NGF, starting between 24 to 72 hours post TBI, continuing for 2 weeks. ### Conditions Module **Conditions:** - Traumatic Brain Injury **Keywords:** - nerve growth factor - traumatic brain injury - intranasal - prognosis - neurological function ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 106 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients who underwent TBI will be chosen to receive NGF randomly. **Intervention Names:** - Drug: nerve growth factor **Label:** nerve growth factor **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients who underwent TBI will be chosen to receive nomral saline randomly. **Intervention Names:** - Drug: nomral saline **Label:** Control **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - nerve growth factor **Description:** The experimental group patients will receive NGF 20ug/d intranasally for 2 weeks. **Name:** nerve growth factor **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Control **Description:** The Placebo Comparator group patients will receive nomral saline 20ug/d intranasally for 2 weeks. **Name:** nomral saline **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Neurological functions will be assessed by GOS(Glasgow Outcome Scale), mRS(modified Rankin Scale),BI(Barthel index). **Measure:** improved neurological functions **Time Frame:** at months 6 post-treatment #### Secondary Outcomes **Description:** HAMA(Hamilton Anxiety Scale ),HAMD(Hamilton Depression Scale). **Measure:** HAMA,HAMD **Time Frame:** at months 6 post-treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Moderate to severe blunt traumatic brain injury defined as Glasgow Coma Scale(GCS) between 7 and 13. Age 18\~65 years. Admission to Jinling Hospital between 24 to 72 hours. Subjects capable of giving informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf. Exclusion Criteria: Skull fracture, Cerebrospinal fluid rhinorrhea. Severe concurrent illness with life expectancy\<6 months or other serious illness which have a major impact on the outcome. Treatment with other investigational agents in the past 4 weeks. Allergy to NGF. Primary ciliary dyskinesia, Asthma, Cystic fibrosis, Viral and bacterial infections, Diabetes mellitus. Inability to provide informed consent. Pregnancy or breast-breeding. Women of childbearing age will be given a pregnancy test during screening to exclude pregnancy. - **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Nanjing **Country:** China **Facility:** Department of Neurology, Jinling Hospital, Nanjing University School of Medicine **State:** Jiangsu **Zip:** 210002 #### Overall Officials **Official 1:** **Affiliation:** Department of Neurology, Jinling Hospital, Nanjing University School of Medicine **Name:** Xinfeng Liu, MD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000006259 - Term: Craniocerebral Trauma - ID: D000020196 - Term: Trauma, Nervous System ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5207 - Name: Brain Injuries - Relevance: HIGH - As Found: Brain Injury - ID: M628 - Name: Brain Injuries, Traumatic - Relevance: HIGH - As Found: Traumatic Brain Injury - ID: M17685 - Name: Wounds and Injuries - Relevance: HIGH - As Found: Injury - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M9349 - Name: Craniocerebral Trauma - Relevance: LOW - As Found: Unknown - ID: M22023 - Name: Trauma, Nervous System - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001930 - Term: Brain Injuries - ID: D000070642 - Term: Brain Injuries, Traumatic - ID: D000014947 - Term: Wounds and Injuries ### Intervention Browse Module - Ancestors - ID: D000050258 - Term: Mitosis Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11900 - Name: Mitogens - Relevance: HIGH - As Found: Mask ### Intervention Browse Module - Meshes - ID: D000008934 - Term: Mitogens ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00229879 **Brief Title:** Rare Tumor Case Review **Official Title:** Rare Tumor Case Review #### Organization Study ID Info **ID:** 04-119 #### Organization **Class:** OTHER **Full Name:** Children's Healthcare of Atlanta ### Status Module #### Completion Date **Date:** 2006-09 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2012-03-16 **Type:** ESTIMATED **Last Update Submit Date:** 2012-03-14 **Overall Status:** TERMINATED #### Start Date **Date:** 2004-12 **Status Verified Date:** 2007-05 #### Study First Post Date **Date:** 2005-09-30 **Type:** ESTIMATED **Study First Submit Date:** 2005-09-13 **Study First Submit QC Date:** 2005-09-28 **Why Stopped:** sufficient data gathered to support conclusion ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Children's Healthcare of Atlanta ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to do a literature review and combine all of the cases of the intrapericardial teratoma tumor and see if some conclusions can be made about this rare tumor in children. **Detailed Description:** We excised an intrapericardial teratoma tumor out of a child approximately one month ago. This is a very uncommon tumor overall, and even more uncommon in children. The majority of reports in the literature are single case reports I would like to report ours, as well as do a literature review to combine all of the cases and see if some conclusions can be made about this rare tumor in children. ### Conditions Module **Conditions:** - Intrapericardial Teratoma Tumor - Tumors **Keywords:** - pediatric health - rare tumor - children - cardiac ### Design Module #### Design Info **Time Perspective:** RETROSPECTIVE **Study Type:** OBSERVATIONAL ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Children with intrapericardial teratoma tumors **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Children with intrapericardial teratoma tumors ### Contacts Locations Module #### Locations **Location 1:** **City:** Atlanta **Country:** United States **Facility:** Children's Healthcare of Atlanta at Egleston **State:** Georgia **Zip:** 30322 #### Overall Officials **Official 1:** **Affiliation:** Emory University **Name:** Brian Kogon, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Emory University **Name:** Kirk R Kanter, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** Emory University **Name:** Paul M. Kirshbom, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009373 - Term: Neoplasms, Germ Cell and Embryonal - ID: D000009370 - Term: Neoplasms by Histologic Type ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M16494 - Name: Teratoma - Relevance: HIGH - As Found: Teratoma - ID: M12318 - Name: Neoplasms, Germ Cell and Embryonal - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms - ID: D000013724 - Term: Teratoma ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05883579 **Acronym:** CTO-PCI **Brief Title:** Application of Coronary Artery Chronic Total Occlusion Scoring Systems **Official Title:** Application of Coronary Artery Chronic Total Occlusion (CTO) Scoring Systems Detecting Their Prediction Ability on CTO Percutaneous Coronary Intervention (PCI) Procedures #### Organization Study ID Info **ID:** CTO-PCI scores application #### Organization **Class:** OTHER **Full Name:** Assiut University ### Status Module #### Completion Date **Date:** 2023-08-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-06-01 **Type:** ACTUAL **Last Update Submit Date:** 2023-05-31 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2023-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-04-01 **Type:** ACTUAL **Status Verified Date:** 2023-05 #### Study First Post Date **Date:** 2023-06-01 **Type:** ACTUAL **Study First Submit Date:** 2023-05-17 **Study First Submit QC Date:** 2023-05-31 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** National Taiwan University Hospital #### Lead Sponsor **Class:** OTHER **Name:** Assiut University #### Responsible Party **Investigator Affiliation:** Assiut University **Investigator Full Name:** Khaled Saber Abdelaal Qayed **Investigator Title:** Principal investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Studying the prediction ability of different CTO scoring systems on Asian CTO PCI population with their relation to technical success and developing a newer stepwise approach depending on these CTO scoring systems for choosing the suggested successful approach considering collateral channel assessment. **Detailed Description:** Study of applying the Japenese CTO, Castle and Progress CTO scores on all coronary CTO PCI cohort done at national Taiwan university hospital (NTUH) Study tools: 1. Basal demographic data collection( age, cardiovascular risk factors, patients clinical data, lesion characteristics, periprocedural complications). 2. The Japanese Chronic Total Occlusion (J-CTO) score calculated for assessment of CTO procedures complexity and predict the likelihood of guide wire crossing within 30 min, as assembled by Morino et al. The J-CTO score is the sum of the following 5 binary parameters: blunt proximal cap, calcification, bending \>45°, length of occluded segment \>20 mm, and previously failed PCI attempt. Each of these independent variables was assigned a value of 1 when present. With increasing probability of difficulty of wire crossing from 0 as easy till 5 as very difficult. 3. Also, the PROGRESS-CTO score calculated (reference website: https://www.progresscto.org/cto with evaluation of 4 baseline angiographic characteristics (proximal cap ambiguity, absence of retrograde collaterals, moderate or severe tortuosity, and LCX CTO) used to determine the likelihood of technical success with CTO PCI. Each of these independent variables was assigned a value of 1 when present. With increasing probability of difficulty of success from 0 as easy till 5 as very difficult. 4. Euro CTO CASTLE scoring calculation The CASTLE (coronary artery bypass graft history, age, stump anatomy, tortuosity degree, length of occlusion, and extent of calcification) model applied retrospectively on the patients with every item taking 1 point if present And Technical failure rates range from 8% (CASTLE score 0 to 1) to 35% (CASTLE score ≥4). 5. Collateral assessment including type (septal, epicardial or bypass grafts), size by Werner classification \[is graded as: 0, no visible connection between the donor and the recipient coronary artery; 1, thread-like connection between the donor and the recipient coronary artery; 2, side-branch like connection between the donor and the recipient coronary artery\], tortuosity degree as by the CC scoring system of the NTUH--\> Channel tortuosity caculated as the presence of ≥2 high-frequency, successive curves (within 2 mm) in the context of epicardial collaterals and ≥1 high-frequency curve that failed to uncoil in diastole for septal channels (thus a measure of channel distensibility). A high-frequency curve is defined as a curve that is \>180° occurring within a segment length \<3× the diameter of the collateral. And all these scores references and calculation items are mentioned in the references below.... ### Conditions Module **Conditions:** - Chronic Total Occlusion of Coronary Artery ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 650 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** doing percutaneous revascularization of chronic coronary total occlusion. **Name:** percutaneous coronary intervention **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** comaprling the three CTO scores for all CTO PCI patients done by experienced operator ( J-CTO scoring, Castle Score and progress scoring ) for prediction of technical success with higher scores indicating higher probability of difficulty along with the CC scoring in predicting higher chances of technical success in retrograde CTO PCI patients. **Measure:** comparison of the effecacy of using CTO scoring systems (J-CTO scoring, Castle Score and progress scoring along with the CC scoring in prediction of technical success. **Time Frame:** Two months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All coronary CTO PCI procedures done at national Taiwan university hospital (NTUH) with their data available for analysis from 2015 till the study data collection step. Exclusion Criteria: * Patients whom data not completed **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** coronary CTO PCI patients done by experienced high volume operator at national Taiwan university hospital (NTUH) with their data available for analysis ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Khaled Qayed, Master **Phone:** +886973547398 **Role:** CONTACT #### Locations **Location 1:** **City:** Taipei **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Khaled Qayed, Dr. - **Phone:** +886973547398 - **Role:** CONTACT **Country:** Taiwan **Facility:** National Taiwan University Hospital **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Assiut University **Name:** Salwa Rushdy, Professor **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** National Taiwan University **Name:** Paul Kao, Professor **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Huang CC, Lee CK, Meng SW, Hung CS, Chen YH, Lin MS, Yeh CF, Kao HL. Collateral Channel Size and Tortuosity Predict Retrograde Percutaneous Coronary Intervention Success for Chronic Total Occlusion. Circ Cardiovasc Interv. 2018 Jan;11(1):e005124. doi: 10.1161/CIRCINTERVENTIONS.117.005124. **PMID:** 29311284 **Citation:** Werner GS, Ferrari M, Heinke S, Kuethe F, Surber R, Richartz BM, Figulla HR. Angiographic assessment of collateral connections in comparison with invasively determined collateral function in chronic coronary occlusions. Circulation. 2003 Apr 22;107(15):1972-7. doi: 10.1161/01.CIR.0000061953.72662.3A. Epub 2003 Mar 24. **PMID:** 12665484 **Citation:** Galassi AR, Werner GS, Boukhris M, Azzalini L, Mashayekhi K, Carlino M, Avran A, Konstantinidis NV, Grancini L, Bryniarski L, Garbo R, Bozinovic N, Gershlick AH, Rathore S, Di Mario C, Louvard Y, Reifart N, Sianos G. Percutaneous recanalisation of chronic total occlusions: 2019 consensus document from the EuroCTO Club. EuroIntervention. 2019 Jun 20;15(2):198-208. doi: 10.4244/EIJ-D-18-00826. **PMID:** 30636678 **Citation:** Fefer P, Knudtson ML, Cheema AN, Galbraith PD, Osherov AB, Yalonetsky S, Gannot S, Samuel M, Weisbrod M, Bierstone D, Sparkes JD, Wright GA, Strauss BH. Current perspectives on coronary chronic total occlusions: the Canadian Multicenter Chronic Total Occlusions Registry. J Am Coll Cardiol. 2012 Mar 13;59(11):991-7. doi: 10.1016/j.jacc.2011.12.007. **PMID:** 22402070 **Citation:** Tajti P, Burke MN, Karmpaliotis D, Alaswad K, Werner GS, Azzalini L, Carlino M, Patel M, Mashayekhi K, Egred M, Krestyaninov O, Khelimskii D, Nicholson WJ, Ungi I, Galassi AR, Banerjee S, Brilakis ES. Update in the Percutaneous Management of Coronary Chronic Total Occlusions. JACC Cardiovasc Interv. 2018 Apr 9;11(7):615-625. doi: 10.1016/j.jcin.2017.10.052. Epub 2018 Mar 14. **PMID:** 29550088 **Citation:** Morino Y, Abe M, Morimoto T, Kimura T, Hayashi Y, Muramatsu T, Ochiai M, Noguchi Y, Kato K, Shibata Y, Hiasa Y, Doi O, Yamashita T, Hinohara T, Tanaka H, Mitsudo K; J-CTO Registry Investigators. Predicting successful guidewire crossing through chronic total occlusion of native coronary lesions within 30 minutes: the J-CTO (Multicenter CTO Registry in Japan) score as a difficulty grading and time assessment tool. JACC Cardiovasc Interv. 2011 Feb;4(2):213-21. doi: 10.1016/j.jcin.2010.09.024. **PMID:** 21349461 **Citation:** Galassi AR, Boukhris M, Azzarelli S, Castaing M, Marza F, Tomasello SD. Percutaneous Coronary Revascularization for Chronic Total Occlusions: A Novel Predictive Score of Technical Failure Using Advanced Technologies. JACC Cardiovasc Interv. 2016 May 9;9(9):911-22. doi: 10.1016/j.jcin.2016.01.036. Epub 2016 Apr 13. **PMID:** 27085580 **Citation:** Christopoulos G, Kandzari DE, Yeh RW, Jaffer FA, Karmpaliotis D, Wyman MR, Alaswad K, Lombardi W, Grantham JA, Moses J, Christakopoulos G, Tarar MNJ, Rangan BV, Lembo N, Garcia S, Cipher D, Thompson CA, Banerjee S, Brilakis ES. Development and Validation of a Novel Scoring System for Predicting Technical Success of Chronic Total Occlusion Percutaneous Coronary Interventions: The PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) Score. JACC Cardiovasc Interv. 2016 Jan 11;9(1):1-9. doi: 10.1016/j.jcin.2015.09.022. **PMID:** 26762904 **Citation:** Szijgyarto Z, Rampat R, Werner GS, Ho C, Reifart N, Lefevre T, Louvard Y, Avran A, Kambis M, Buettner HJ, Di Mario C, Gershlick A, Escaned J, Sianos G, Galassi A, Garbo R, Goktekin O, Meyer-Gessner M, Lauer B, Elhadad S, Bufe A, Boudou N, Sievert H, Martin-Yuste V, Thuesen L, Erglis A, Christiansen E, Spratt J, Bryniarski L, Clayton T, Hildick-Smith D. Derivation and Validation of a Chronic Total Coronary Occlusion Intervention Procedural Success Score From the 20,000-Patient EuroCTO Registry: The EuroCTO (CASTLE) Score. JACC Cardiovasc Interv. 2019 Feb 25;12(4):335-342. doi: 10.1016/j.jcin.2018.11.020. Epub 2019 Jan 30. **PMID:** 30711551 **Citation:** Ellis SG, Burke MN, Murad MB, Graham JJ, Badawi R, Toma C, Meltser H, Nair R, Buller C, Whitlow PL; CAPS Group. Predictors of Successful Hybrid-Approach Chronic Total Coronary Artery Occlusion Stenting: An Improved Model With Novel Correlates. JACC Cardiovasc Interv. 2017 Jun 12;10(11):1089-1098. doi: 10.1016/j.jcin.2017.03.016. **PMID:** 28595879 **Citation:** Li Y, Xu N, Zhang J, Li M, Lu Z, Wei M, Lu B, Zhang Y. Procedural success of CTO recanalization: Comparison of the J-CTO score determined by coronary CT angiography to invasive angiography. J Cardiovasc Comput Tomogr. 2015 Nov-Dec;9(6):578-84. doi: 10.1016/j.jcct.2015.07.005. Epub 2015 Jul 23. **PMID:** 26232276 **Citation:** Salinas P, Gonzalo N, Moreno VH, Fuentes M, Santos-Martinez S, Fernandez-Diaz JA, Amat-Santos IJ, Ojeda FB, Borrego JC, Cuesta J, Hernandez JMT, Diego-Nieto A, Dubois D, Galeote G, Goicolea J, Gutierrez A, Jimenez-Fernandez M, Jimenez-Mazuecos J, Jurado A, Lacunza J, Lee DH, Lopez M, Lozano F, Martin-Moreiras J, Martin-Yuste V, Millan R, Minana G, Mohandes M, Morales-Ponce FJ, Nunez J, Ojeda S, Pan M, Rivero F, Robles J, Rodriguez-Leiras S, Rojas S, Rondan J, Rumiz E, Sabate M, Sanchis J, Vaquerizo B, Escaned J. Choice of CTO scores to predict procedural success in clinical practice. A comparison of 4 different CTO PCI scores in a comprehensive national registry including expert and learning CTO operators. PLoS One. 2021 Apr 2;16(4):e0245898. doi: 10.1371/journal.pone.0245898. eCollection 2021. **PMID:** 33798205 **Citation:** Kalogeropoulos AS, Alsanjari O, Keeble TR, Tang KH, Konstantinou K, Katsikis A, Jagathesan R, Aggarwal RK, Clesham GJ, Kelly PA, Werner GS, Hildick-Smith D, Davies JR, Karamasis G. CASTLE score versus J-CTO score for the prediction of technical success in chronic total occlusion percutaneous revascularisation. EuroIntervention. 2020 Apr 3;15(18):e1615-e1623. doi: 10.4244/EIJ-D-19-00352. **PMID:** 31270036 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: Rare - Name: Rare Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: HIGH - As Found: Chronic ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01423279 **Brief Title:** The Effect of a Diabetic- and a Kidney-like Environment on Gene and Protein Expression in Cultured EC and SMC **Official Title:** The Effect of a Diabetic- and a Kidney-like Environment on Gene and Protein Expression in Mono- and Co-cultured Endothelial and Smooth Muscle Cells #### Organization Study ID Info **ID:** MMC11-0074CTIL #### Organization **Class:** OTHER **Full Name:** Meir Medical Center #### Secondary ID Infos **Domain:** Meir Medical Center , Israel **ID:** 0074-11-MMC **Type:** OTHER ### Status Module #### Completion Date **Date:** 2022-08 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2021-09-01 **Type:** ACTUAL **Last Update Submit Date:** 2021-08-31 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2022-08 **Type:** ESTIMATED #### Start Date **Date:** 2013-02 **Status Verified Date:** 2021-08 #### Study First Post Date **Date:** 2011-08-25 **Type:** ESTIMATED **Study First Submit Date:** 2011-08-24 **Study First Submit QC Date:** 2011-08-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Meir Medical Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** This research is NOT part of an interventional trial, however the investigators use umbilical cord after birth for isolating endothelial and smooth muscle cells for academic research. **Detailed Description:** Isolation and culturing of endothelial and smooth muscle muscles for academic research ### Conditions Module **Conditions:** - Endothelial Dysfunction - Disorder of Smooth Muscle ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** OTHER #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Measure:** The effect of a Diabetic- and a Kidney-like environment on gene and protein expression in mono- and co-cultured endothelial and smooth muscle cells **Time Frame:** one year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * normal pregnancy Exclusion Criteria: - **Healthy Volunteers:** True **Sampling Method:** PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Women after normal birth ### Contacts Locations Module #### Locations **Location 1:** **City:** Kfar Saba **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Tali Zitman-Gal, PhD - **Phone:** +972-9-7472401 - **Role:** CONTACT ***Contact 2:*** - **Name:** Tali Zitman-Gal, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Israel **Facility:** Laboratory of Renal Physiology, Meir Medical Center , **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Nephrology dept. Meir Medical Center, Kfar Saba , Israel **Name:** Sydney Benchetrit, MD **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Zitman-Gal T, Green J, Pasmanik-Chor M, Oron-Karni V, Bernheim J. Endothelial pro-atherosclerotic response to extracellular diabetic-like environment: possible role of thioredoxin-interacting protein. Nephrol Dial Transplant. 2010 Jul;25(7):2141-9. doi: 10.1093/ndt/gfp768. Epub 2010 Jan 19. **PMID:** 20089511 **Citation:** Talmor-Barkan Y, Bernheim J, Green J, Benchetrit S, Rashid G. Calcitriol counteracts endothelial cell pro-inflammatory processes in a chronic kidney disease-like environment. J Steroid Biochem Mol Biol. 2011 Mar;124(1-2):19-24. doi: 10.1016/j.jsbmb.2011.01.001. Epub 2011 Jan 12. **PMID:** 21236342 **Citation:** Talmor-Barkan Y, Rashid G, Weintal I, Green J, Bernheim J, Benchetrit S. Low extracellular Ca2+: a mediator of endothelial inflammation. Nephrol Dial Transplant. 2009 Nov;24(11):3306-12. doi: 10.1093/ndt/gfp354. Epub 2009 Jul 18. **PMID:** 19617602 **Citation:** Rashid G, Plotkin E, Klein O, Green J, Bernheim J, Benchetrit S. Parathyroid hormone decreases endothelial osteoprotegerin secretion: role of protein kinase A and C. Am J Physiol Renal Physiol. 2009 Jan;296(1):F60-6. doi: 10.1152/ajprenal.00622.2007. Epub 2008 Oct 22. **PMID:** 18945829 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01837979 **Acronym:** DBS&CFF **Brief Title:** Down Syndrome Screening Based on Dried Blood Spots and Cell-free Fetal DNA **Official Title:** A Clinical Trial to Explore a New Prenatal Screening and Diagnosis Pattern for Fetal Chromosomal Abnormalities With Dried Blood Spots and Cell-free Fetal DNA. #### Organization Study ID Info **ID:** Down syndrome screening #### Organization **Class:** OTHER **Full Name:** Peking Union Medical College Hospital ### Status Module #### Completion Date **Date:** 2015-01 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** ENROLLING_BY_INVITATION #### Last Update Post Date **Date:** 2013-04-23 **Type:** ESTIMATED **Last Update Submit Date:** 2013-04-18 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2015-01 **Type:** ESTIMATED #### Start Date **Date:** 2013-04 **Status Verified Date:** 2013-04 #### Study First Post Date **Date:** 2013-04-23 **Type:** ESTIMATED **Study First Submit Date:** 2013-04-14 **Study First Submit QC Date:** 2013-04-18 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Peking Union Medical College Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** There are 26,600 Down Syndrome newborns every year in China. The economic burden of this disease is 65,000 USD for lifetime of every patient. The common prenatal screening and diagnosis procedure for fetal chromosomal abnormalities in China is maternal serum prenatal screening in second trimester followed by amniocentesis. The detection rate of MSS is 70%-75% with 5% false positive rate. There are only 13.9% of pregnant women can receive prenatal screening testing in China. It is very urgent that we build a training system and convenient, efficient, cost-effective procedure suitable to rural China. The use of dried blood spots (DBS) technology in conjunction with the second trimester prenatal screening protocol has been proved to be as efficient as serum screening by our previous study. Noninvasive prenatal testing that uses cell free fetal DNA (cff DNA) from the plasma of pregnant women offers a tremendous potential for fetal chromosomal abnormalities. A positive test should be followed by invasive prenatal diagnosis to confirm the test results. Cff DNA is a good supplement to the DBS technology in rural China. A combination of the two methods can increase the screening rate and accuracy without increasing the demand of amniocentesis and cytogenetic test. This procedure with adequate training system should be suitable to rural China. Our study will build a training system for DBS and cffDNA prenatal screening procedure in Pinggu, Beijing. Two thousand pregnant women will receive prenatal screening. DBS sample will be collected in the second trimester, Cff DNA is offered to confirm the positive screening test results, and lastly amniocentesis is offered for confirmation of the test results. All of the pregnancy and neonatal outcomes will be followed. We can estimate the efficiency and cost-effectiveness of DBS followed with cff DNA screening procedure. **Detailed Description:** Goals To build a training system and DBS and cffDNA prenatal screening procedure that is suitable to rural China. Objectives Develop a standardized prenatal screening test training program. Evaluate the efficiency and cost-effectiveness of DBS and cffDNA prenatal screening procedure in rural China. Specific activities * Train the medical staff: Select two hospitals in Pinggu Village. Train all of the obstetricians and family doctors, nurses in these counties about the prenatal screening test as well as DBS and cff DNA technology. Build a series of standardized training profiles for the doctors and nurses. Evaluate the knowledge of the trained staff and compare the prenatal screening rate as well as some key health outcome variables pre and post the training. * collect DBS sample in the 2nd trimestaer: Two thousand pregnant women will receive prenatal screening. DBS sample together with serum screening samples will be collected in the second trimester. * Cff DNA for DBS high risk pregnant women: Cff DNA is offered to confirm the positive screening test results. * amniocentesis for Cff DNA high risk pregnant women: Amniocentesis is offered for confirmation of the test results. * Follpw-up the neonatal outcome: All of the pregnancy and neonatal outcomes will be followed. * Statistical analysis: We can estimate the efficiency and cost-effectiveness of DBS followed with cff DNA screening procedure. We can give the recommendation to the government for a potential expansion of new screening diagnosis procedure to be used in the countryside. Analytic methods Build the database by visual Foxpro 5.0. Use the SAS9.2 software to do statistical analysis. Expected results and products Develop standardized prenatal screening test training program for the doctors and nurses in rural China. Estimate the training outcome. Estimate the detection rate of DBS and compare with maternal serum screening test. Estimate the sensitivity of specificity of cffDNA test. Estimate the efficiency and cost-effectiveness of DBS and cff DNA screening procedure. Make sure if DBS and cffDNA is suitable to rural China and successfully decreases the birth defects. Timetable * Year 1 Select the hospitals and form the contracts with local staff. Develop the training program and finish training. Evaluate the training outcome. Start to collect DBS samples followed with cffDNA. Enroll the pregnant women in the second trimester who sign the consent form. * Year 2 Follow-up the pregnancy and neonatal outcomes. Finish the statistical analysis and paper writing. ### Conditions Module **Conditions:** - Trisomy 21 **Keywords:** - prenatal testing for fetal aneuploidy - dried blood spots - cell-free fetal DNA - detection rate - cost-effectiveness ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 2000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** cell-free fetal DNA for Dried blood spots samples in high risk pregnant women. **Intervention Names:** - Procedure: cell-free fetal DNA **Label:** DBS screening test #### Arm Group 2 **Description:** cell-free fetal DNA for maternal serum screening test samples in high risk pregnant women. **Intervention Names:** - Procedure: cell-free fetal DNA **Label:** maternal serum screening test ### Interventions #### Intervention 1 **Arm Group Labels:** - DBS screening test - maternal serum screening test **Description:** cell-free fetal DNA for DBS and maternal serum screening high risk pregnant women. Comparison of multiple Down's syndrome screening tests. **Name:** cell-free fetal DNA **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Detection rate of trisomy 21 based on dried blood spots and cell-free fetal DNA. Compare the detection rate of screening test on dried blood spots with maternal serum screening test. **Measure:** detection rate **Time Frame:** April, 2015 #### Secondary Outcomes **Description:** the number of patients can be detected in Down syn and the proportion of the actual number of cases to screening positive cases number **Measure:** positive predictive value and negative predictive value **Time Frame:** 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Single gestation; * Chinese natives or non-Chinese citizen of Chinese ancestry; * 15-20+6 weeks of gestation; * be able to accept follow-ups of the pregnancy outcome; * healthy, without other major or chronic diseases; Exclusion Criteria: * N/A **Healthy Volunteers:** True **Maximum Age:** 35 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT **Study Population:** pregnant women with 15-20+6 weeks of gestation ### Contacts Locations Module #### Locations **Location 1:** **City:** Beijing **Country:** China **Facility:** Department of ob gyn, Peking Union Medical College Hospital **State:** Beijing **Zip:** 100730 #### Overall Officials **Official 1:** **Affiliation:** Peking Union Medical College **Name:** Liangkun Ma, MD **Role:** STUDY_DIRECTOR ## Annotation Section ### Unposted Annotation #### Event: RELEASE - Date: 2020-06-13 - Date Unknown: Unknown #### Event: RESET - Date: 2020-06-29 - Date Unknown: Unknown ## Derived Section ### Condition Browse Module - Ancestors - ID: D000000782 - Term: Aneuploidy - ID: D000002869 - Term: Chromosome Aberrations - ID: D000010335 - Term: Pathologic Processes - ID: D000058674 - Term: Chromosome Duplication - ID: D000008607 - Term: Intellectual Disability - ID: D000019954 - Term: Neurobehavioral Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000000015 - Term: Abnormalities, Multiple - ID: D000000013 - Term: Congenital Abnormalities - ID: D000025063 - Term: Chromosome Disorders - ID: D000030342 - Term: Genetic Diseases, Inborn ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M4112 - Name: Aneuploidy - Relevance: LOW - As Found: Unknown - ID: M7489 - Name: Down Syndrome - Relevance: HIGH - As Found: Trisomy 21 - ID: M8219 - Name: Exanthema - Relevance: LOW - As Found: Unknown - ID: M6109 - Name: Chromosome Aberrations - Relevance: LOW - As Found: Unknown - ID: M17066 - Name: Trisomy - Relevance: HIGH - As Found: Trisomy - ID: M23023 - Name: Chromosome Disorders - Relevance: LOW - As Found: Unknown - ID: M11589 - Name: Intellectual Disability - Relevance: LOW - As Found: Unknown - ID: M21826 - Name: Neurobehavioral Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M14 - Name: Abnormalities, Multiple - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: T1195 - Name: Chromosomal Triplication - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004314 - Term: Down Syndrome - ID: D000014314 - Term: Trisomy ### Misc Info Module #### Submission Tracking - Estimated Results First Submit Date: 2020-06-13 ##### Submission Infos - MCP Release N: Unknown - Release Date: 2020-06-13 - Reset Date: 2020-06-29 - Unrelease Date: Unknown - Unrelease Date Unknown: Unknown - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05853679 **Brief Title:** Regular Antibacterial Photodynamic Therapy on Oral Hygiene in Elderly Residents **Official Title:** Effect of Regular Antibacterial Photodynamic Therapy on Oral Hygiene in Elderly Residents of a 24-hour Care Facility #### Organization Study ID Info **ID:** RSAA2021 #### Organization **Class:** INDUSTRY **Full Name:** Koite Health Oy ### Status Module #### Completion Date **Date:** 2023-04-18 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-08-08 **Type:** ACTUAL **Last Update Submit Date:** 2023-08-07 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-04-18 **Type:** ACTUAL #### Start Date **Date:** 2022-09-01 **Type:** ACTUAL **Status Verified Date:** 2023-08 #### Study First Post Date **Date:** 2023-05-11 **Type:** ACTUAL **Study First Submit Date:** 2023-04-21 **Study First Submit QC Date:** 2023-05-02 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Helsinki **Class:** OTHER **Name:** City of Helsinki #### Lead Sponsor **Class:** INDUSTRY **Name:** Koite Health Oy #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Around 40 people will participate in the study. The study participants will be recruited from service homes in the City of Helsinki. The subjects will be randomized into two groups. One of the groups will receive daily photodynamic Lumoral treatment for 2 months in a home care unit according to a separate instruction manual. At the beginning of the study, all subjects will receive an oral cleaning and will also be provided with electric toothbrushes. In addition, residents and care home personnel will be instructed on daily tooth cleaning. During the study, all participants will undergo clinical measurements and an assessment of the oral inflammatory load. The samples will be stored for later analysis. In addition, residents or care home personnel answer questions about oral self-care. These measurements and examinations will be carried out at the start of the study and two months after the start of the study. After the end of the study, participants will continue to be treated according to their usual care and individual care plan. **Detailed Description:** The aim of this study is to investigate the effect of regular antibacterial photodynamic treatment in service accommodation on the oral hygiene of elderly people. The information from this study can be used to promote oral hygiene among residents in 24-hour care. Lumoral is a CE-marked medical home appliance that has been shown to be effective in reducing plaque development and the amount of harmful bacteria in plaque. The efficacy of the device is based on an antibacterial photodynamic process, whereby a photosensitive substance in Lumorinse attaches itself to the bacterial coating and is activated as an antibacterial agent by light. The antibacterial effect is directly targeted at the plaque, reducing the impact on the normal oral flora. Preliminary studies have shown that the method reduces the inflammatory factors associated with periodontitis. The study is being carried out in collaboration with the City of Helsinki Oral Health Department, the Metropolia University of Applied Sciences Oral Care Teaching Hospital and the University of Helsinki Department of Oral and Maxillofacial Surgery. The registrar of the study is the University of Helsinki. The study will be conducted in accordance with Good Clinical Practice (GCP) and ISO 14155 ("Clinical trials on medical devices. Good Clinical Practice"). The target population of the study will be residents in 24-hour care with at least 10 of their own teeth, who are judged by the caregiver to be able to participate in the study and who give written informed consent to participate in the study. Approximately 40 people will participate in the study. They will be recruited from the City of Helsinki's service homes. The subjects will be randomized into two groups. One of the groups will receive daily photodynamic Lumoral treatment for 2 months in a residential unit according to a separate instruction manual. At the beginning of the study, all subjects will receive an oral cleaning and will also be provided with electric toothbrushes. In addition, residents and carers will be instructed on daily tooth cleaning. During the study, all patients will undergo clinical measurements (VPI, CPITN, dry mouth) and an assessment of the oral inflammatory load using the aMMP-8 bowel inflammation test. The occlusion samples will be stored for later analysis. In addition, residents or caregivers answer questions about oral self-care. These measurements and examinations will be carried out at the start of the study and two months after the start of the study. After the end of the study, subjects will continue to be treated according to their usual care and individual care plan. ### Conditions Module **Conditions:** - Dental Plaque - Pus Collection - Oral Disease - Dryness Oral - Tooth Decay **Keywords:** - Lumoral - Lumorinse - Plaque Control - Anti-bacterial photodynamic therapy - aMMP-8 - Care home ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Masking Description:** Randomization of patients is done by using sealed envelope technique at the end of the Baseline visit. During the Baseline visit, participants, care providers, and investigators do not know to which group the participant will be allocated. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 31 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A complete clinical intraoral examination shall be performed for all subjects. Same demographic and clinical data will be obtained from subjects in both arms. The study group shall receive the Lumoral treatment -device, Lumorinse -tablets and instructions for their use. All subjects shall receive new electric toothbrushes, standard oral hygiene instructions for the use of an electric toothbrush, interdental brush, and dental floss. **Intervention Names:** - Device: Lumoral Treatment **Label:** Lumoral Treatment (Study group) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** A complete clinical intraoral examination shall be performed for all subjects. Same demographic and clinical data will be obtained from subjects in both arms. All subjects shall receive new electric toothbrushes, standard oral hygiene instructions for the use of an electric toothbrush, interdental brush, and dental floss. **Intervention Names:** - Device: Lumoral Treatment - Other: Standard oral hygiene instructions according to the Finnish Dental Association **Label:** Control group **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Control group - Lumoral Treatment (Study group) **Description:** The device will be used 5 to 7 times per week according to the manufacturer's instructions. **Name:** Lumoral Treatment **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Control group **Description:** Participants will be instructed to clean their teeth twice per day by an electric toothbrush, an interdental brush, and flossing. **Name:** Standard oral hygiene instructions according to the Finnish Dental Association **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** A change in baseline oral self-care and hygiene questionnaire compared to 2-month follow-up. The questionnaires are completed by the study participants. **Measure:** Change in oral hygiene / patient experience **Time Frame:** 2 months **Description:** Change in Visible Plaque Index: * A full-mouth assessment at 4 sites per tooth will be made at baseline and at the 2 month follow-up visit * VPI is reported as the percentage (%) of sites with positive findings * Dichotomous scoring to each site of the tooth as plaque" 1 present" and" 0 absent" * Calculation formula: number of plaque sites/ 4 times number of teeth **Measure:** Visible Plaque Index **Time Frame:** 2 months **Description:** Change in oral inflammatory load measured by the aMMP-8 chairside speed test: * The aMMP-8 marker analysis will be performed using the Periosafe chair-side test (Dentognostics GmbH) according to the manufacturer's instructions. * Oral rinse samples will be stored for further analysis. * Further analysis includes aMMP-8 and its regulators by biochemical enzyme/molecule assays, immunoassays, and proteomics analysis. **Measure:** aMMP-8 chaiside test **Time Frame:** 2 months #### Secondary Outcomes **Description:** Change in dryness in mouth. The data will be obtained by the thorough oral inspection performed by the investigators, and by a questionnaire (patient outcome). Clinical assessment of moisture/dryness of oral mucosa (score 0-2): 0 = Saliva secretion looks normal (saliva serous and running) 1. = Mucous membrane of the mouth shiny and tightening/ saliva foamy or mucous/ little clear saliva at the base of the mouth 2. = Mouth completely dry, mirror sticking to cheek or tongue, mucous membranes often reddened/ bumps on tongue surface disappeared/ scab on melting. **Measure:** Dryness in mouth **Time Frame:** 2 months **Description:** The data will be obtained by a oral health questionnaire (patient outcome). **Measure:** Dryness in mouth (patient experience) **Time Frame:** 2 months **Description:** The study participants will answer a questionnaire related to the usability of Lumoral Treatment device. **Measure:** Usability of Lumoral Treatment device (patient outcome) **Time Frame:** 2 months **Description:** The care home nursing staff will answer a questionnaire related to their view of the usability of Lumoral Treatment device. The questionnaire will also ask about how easy or hard it was to instruct the care home patients to use the device on a near-daily basis and if they would recommend the device for further use or to their customers. **Measure:** Usability of Lumoral Treatment device (care home personnel outcome) **Time Frame:** 2 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * A 24-hour care resident; * Understand and able to give consent to the study; * At least 10 functional teeth in the mouth (including implants); * Able to brush teeth and follow the instruction for use Lumoral treatment, based on the assessment by the nursing staff. Exclusion Criteria: * Incapable of participating in the study based on the assessment of the nursing staff * Toothless or less than 10 functional teeth in the mouth (including implants) **Minimum Age:** 60 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Helsinki **Country:** Finland **Facility:** City of Helsinki, Health and Social Services, Senior Services **State:** Uusimaa **Zip:** 00099 #### Overall Officials **Official 1:** **Affiliation:** University of Helsinki **Name:** Timo Sorsa, Professor **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** City of Helsinki **Name:** Riitta Saarela **Role:** STUDY_CHAIR **Official 3:** **Affiliation:** Helsinki University Central Hospital **Name:** Tommi Pätilä **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** De Visschere L, de Baat C, De Meyer L, van der Putten GJ, Peeters B, Soderfelt B, Vanobbergen J. The integration of oral health care into day-to-day care in nursing homes: a qualitative study. Gerodontology. 2015 Jun;32(2):115-22. doi: 10.1111/ger.12062. Epub 2013 Jun 20. **PMID:** 23786637 **Citation:** Lahteenmaki H, Patila T, Raisanen IT, Kankuri E, Tervahartiala T, Sorsa T. Repeated Home-Applied Dual-Light Antibacterial Photodynamic Therapy Can Reduce Plaque Burden, Inflammation, and aMMP-8 in Peri-Implant Disease-A Pilot Study. Curr Issues Mol Biol. 2022 Mar 8;44(3):1273-1283. doi: 10.3390/cimb44030085. **PMID:** 35723308 **Citation:** Nikinmaa S, Moilanen N, Sorsa T, Rantala J, Alapulli H, Kotiranta A, Auvinen P, Kankuri E, Meurman JH, Patila T. Indocyanine Green-Assisted and LED-Light-Activated Antibacterial Photodynamic Therapy Reduces Dental Plaque. Dent J (Basel). 2021 May 3;9(5):52. doi: 10.3390/dj9050052. **PMID:** 34063662 **Citation:** Nothdurft HD, Jelinek T, Pechel SM, Hess F, Maiwald H, Marschang A, von Sonnenburg F, Weinke T, Loscher T. Stand-by treatment of suspected malaria in travellers. Trop Med Parasitol. 1995 Sep;46(3):161-3. **PMID:** 8533018 **Citation:** Nishizawa T, Niikura Y, Akasaka K, Watanabe M, Kurai D, Amano M, Ishii H, Matsushima H, Yamashita N, Takizawa H. Pilot study for risk assessment of aspiration pneumonia based on oral bacteria levels and serum biomarkers. BMC Infect Dis. 2019 Sep 2;19(1):761. doi: 10.1186/s12879-019-4327-2. **PMID:** 31477059 **Citation:** Saarela RKT, Hiltunen K, Mantyla P, Pitkala KH. Changes in Institutionalized Older People's Dentition Status in Helsinki, 2003-2017. J Am Geriatr Soc. 2020 Jan;68(1):221-223. doi: 10.1111/jgs.16230. Epub 2019 Oct 26. No abstract available. **PMID:** 31654530 **Citation:** Saarela RKT, Hiltunen K, Kautiainen H, Roitto HM, Mantyla P, Pitkala KH. Oral hygiene and health-related quality of life in institutionalized older people. Eur Geriatr Med. 2022 Feb;13(1):213-220. doi: 10.1007/s41999-021-00547-8. Epub 2021 Jul 27. **PMID:** 34313976 **Citation:** Suominen AL, Varsio S, Helminen S, Nordblad A, Lahti S, Knuuttila M. Dental and periodontal health in Finnish adults in 2000 and 2011. Acta Odontol Scand. 2018 Jul;76(5):305-313. doi: 10.1080/00016357.2018.1451653. Epub 2018 Mar 16. **PMID:** 29546776 **Citation:** Willumsen T, Karlsen L, Naess R, Bjorntvedt S. Are the barriers to good oral hygiene in nursing homes within the nurses or the patients? Gerodontology. 2012 Jun;29(2):e748-55. doi: 10.1111/j.1741-2358.2011.00554.x. Epub 2011 Oct 24. **PMID:** 22023222 #### See Also Links **Label:** Hernández M, Baeza M, Räisänen IT, et al. Active MMP-8 Quantitative Test as an Adjunctive Tool for Early Diagnosis of Periodontitis. Diagnostics (Basel). 2021;11(8):1503). **URL:** https://doi.org/10.3390/diagnostics11081503 **Label:** Hiltunen K, Julkunen L, Vesa T et al. 2020. Residents' oral health in long-term 24-hour care for the elderly in Helsinki 2018, Studies and reports of the Social and Health Services Department, City of Helsinki Social and Health Services Department **URL:** https://www.hel.fi/static/sote/julkaisut/asukkaiden-suunterveys-iakkaiden-pitkaaikaisessa-ymparivuorokautisessa-hoidossa.pdf **Label:** Suominen L, Vehkalahti M, Knuutila M. Health, functional capacity and well-being in Finland 2011. THL report 68/2012. **URL:** https://www.julkari.fi/bitstream/handle/10024/90832/Rap068_2012_netti.pdf?sequence=1&isAllowed=y ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003741 - Term: Dental Deposits - ID: D000014076 - Term: Tooth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6928 - Name: Dental Caries - Relevance: LOW - As Found: Unknown - ID: M17724 - Name: Xerostomia - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: HIGH - As Found: Oral Disease - ID: M6970 - Name: Dental Plaque - Relevance: HIGH - As Found: Dental Plaque - ID: M6938 - Name: Dental Deposits - Relevance: LOW - As Found: Unknown - ID: M16831 - Name: Tooth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003773 - Term: Dental Plaque - ID: D000009059 - Term: Mouth Diseases ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06417879 **Brief Title:** Attitude And Practice of Egyptian Dental Practitioners Regarding Restoration Repair **Official Title:** Attitude And Practice of Egyptian Dental Practitioners Regarding Restoration Repair: A Cross-Sectional Study #### Organization Study ID Info **ID:** 14422021484209 #### Organization **Class:** OTHER **Full Name:** Cairo University ### Status Module #### Completion Date **Date:** 2025-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-08 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-12 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cairo University #### Responsible Party **Investigator Affiliation:** Cairo University **Investigator Full Name:** Habiba Hassan Mostafa Hosni **Investigator Title:** Masters candidate at faculty of dentistry Cairo University **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is a cross-sectional study with an aim to evaluate the variations in self-reporting attitude and practice of restoration repair among Egyptian dental practitioners utilizing a survey questionnaire. It is undeniable that "Minimally invasive dentistry" nowadays offers solutions to prolong the longevity of resin composite restoration with adhesive technology. Due to the limited lifespan of dental restorations, defects are more prone to occur in the existing restorations and thus require dental treatment. it was stated in the literature that repairing could offer better advantages even though replacement of a restoration is a more common choice by many clinicians. Since the concept of preserving tooth structure nowadays plays a major part in dental practice, invistigators need to understand where Egyptian dental practitioners stand in understanding and applying the concept of restoration repair. Assessment of knowledge and the missing data regarding the concept of repair that dentists in Egypt have could help understand their awareness in applying conservatism in daily practice. There were some research about knowledge, attitude and practice of restoration repair in of dental practitioners in other countries, but little was known in Egypt. ### Conditions Module **Conditions:** - Practice - Attitude - Dental Restoration Repair ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 316 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Survey Questionnaire (Percentages) **Measure:** Practice of Egyptian dental practitioners toward repair restoration **Time Frame:** After data collection (4 months) **Description:** Survey Questionnaire (Percentages) **Measure:** Attitude of Egyptian dental practitioners toward repair restoration **Time Frame:** After data collection (4 months) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Egyptian dental practitioners that have completed their bachelor's degree, internship, have practice license and registered in the Egyptian Dental Syndicate. Exclusion Criteria: * Undergraduate dental students * Dental practitioners that are still in internship * Dental practitioners that don't have their practice license yet. * Dental practitioners that are not registered in the Egyptian Dental Syndicate. **Healthy Volunteers:** True **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Egyptian dental practitioners that have completed their bachelor's degree, internship, have practice license and registered in the Egyptian Dental Syndicate. ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: Rare - Name: Rare Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00003479 **Brief Title:** Antineoplaston Therapy in Treating Patients With Ependymoma **Official Title:** Phase II Study of Antineoplastons A10 and AS2-1 Infusions in Patients With Ependymoma #### Organization Study ID Info **ID:** CDR0000066516 #### Organization **Class:** OTHER **Full Name:** Burzynski Research Institute #### Secondary ID Infos **Domain:** Burzynski Research Institute, Inc. **ID:** BC-BT-24 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2000-10 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-02-23 **Type:** ACTUAL **Last Update Submit Date:** 2022-02-18 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2000-10 **Type:** ACTUAL #### Results First Post Date **Date:** 2017-02-17 **Type:** ACTUAL **Results First Submit Date:** 2016-12-28 **Results First Submit QC Date:** 2016-12-28 #### Start Date **Date:** 1966-07 **Status Verified Date:** 2022-02 #### Study First Post Date **Date:** 2003-01-27 **Type:** ESTIMATED **Study First Submit Date:** 1999-11-01 **Study First Submit QC Date:** 2003-01-26 **Why Stopped:** Slow accrual ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Burzynski Research Institute #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** RATIONALE: Current therapies for patients with ependymoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of patients with ependymoma . PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with ependymoma. **Detailed Description:** OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in patients with ependymoma as measured by an objective response to therapy (complete response, partial response) or stable disease. * To determine the safety and tolerance of Antineoplaston therapy in patients with ependymoma OVERVIEW: This is a single arm, open-label study in which patients with ependymoma receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with a complete or partial response or with stable disease may continue treatment. To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study ### Conditions Module **Conditions:** - Ependymoma **Keywords:** - Ependymoma - Anaplastic Ependymoma ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 9 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. **Intervention Names:** - Drug: Antineoplaston therapy (Atengenal + Astugenal) **Label:** Antineoplaston therapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Antineoplaston therapy **Description:** Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal). **Name:** Antineoplaston therapy (Atengenal + Astugenal) **Other Names:** - A10 (Atengenal); AS2-1 (Astugenal) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), \>=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), \<50% decrease and \<25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), \>=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions. **Measure:** Number of Participants With Objective Response **Time Frame:** 12 months #### Secondary Outcomes **Description:** 6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival **Measure:** Percentage of Participants Who Survived **Time Frame:** 6 months, 12 months, 24 months, 36 months, 48 months, 60 months ### Eligibility Module **Eligibility Criteria:** DISEASE CHARACTERISTICS: * Histologically confirmed ependymoma that is unlikely to respond to existing therapy and for which no curative therapy exists * Evidence of residual tumor (\>= 5mm) by MRI scan performed within two weeks prior to study entry * No brain stem tumors PATIENT CHARACTERISTICS: Age: * 6 months and over Performance status: * Karnofsky 60-100% Life expectancy: * At least 2 months Hematopoietic: * WBC at least 2,000/mm3 * Platelet count greater than 50,000/mm3 Hepatic: * Bilirubin no greater than 2.5 mg/dL * SGOT/SGPT no greater than 5 times upper limit of normal * No hepatic failure Renal: * Creatinine no greater than 2.5 mg/dL * No renal failure * No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: * No severe heart disease * No uncontrolled hypertension * No history of congestive heart failure * No history of other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: * No severe lung disease Other: * Not pregnant or nursing * Fertile patients must use effective contraception during and for 4 weeks after study * No serious active infections or fever * No other serious concurrent disease PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy and recovered * No concurrent immunomodulating agents Chemotherapy: * At least 4 weeks since prior chemotherapy and recovered (6 weeks for nitrosoureas) * No concurrent antineoplastic agents Endocrine therapy: * Concurrent corticosteroids for cerebral edema allowed (must be on stable dose for at least 1 week prior to study) Radiotherapy: * At least 8 weeks since prior radiotherapy and recovered Surgery: * Not specified Other: * No prior antineoplaston therapy **Maximum Age:** 99 Years **Minimum Age:** 6 Months **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Houston **Country:** United States **Facility:** Burzynski Clinic **State:** Texas **Zip:** 77055-6330 #### Overall Officials **Official 1:** **Affiliation:** Burzynski Research Institute **Name:** Stanislaw R. Burzynski, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### See Also Links **Label:** Burzynski Research Institute **URL:** http://www.burzynskiresearch.com **Label:** Burzynski Clinic **URL:** http://www.burzynskiclinic.com ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005910 - Term: Glioma - ID: D000018302 - Term: Neoplasms, Neuroepithelial - ID: D000017599 - Term: Neuroectodermal Tumors - ID: D000009373 - Term: Neoplasms, Germ Cell and Embryonal - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009380 - Term: Neoplasms, Nerve Tissue ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M7965 - Name: Ependymoma - Relevance: HIGH - As Found: Ependymoma - ID: M9020 - Name: Glioma - Relevance: LOW - As Found: Unknown - ID: M20446 - Name: Neoplasms, Neuroepithelial - Relevance: LOW - As Found: Unknown - ID: M19845 - Name: Neuroectodermal Tumors - Relevance: LOW - As Found: Unknown - ID: M20388 - Name: Neuroectodermal Tumors, Primitive - Relevance: LOW - As Found: Unknown - ID: M12318 - Name: Neoplasms, Germ Cell and Embryonal - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12325 - Name: Neoplasms, Nerve Tissue - Relevance: LOW - As Found: Unknown - ID: T2093 - Name: Ependymoma - Relevance: HIGH - As Found: Ependymoma - ID: T365 - Name: Anaplastic Ependymoma - Relevance: LOW - As Found: Unknown - ID: T2519 - Name: Glioma - Relevance: LOW - As Found: Unknown - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004806 - Term: Ependymoma ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module **Description:** Nine patients were recruited between July 1996 and March 2000. All study subjects were seen at the Burzynski Clinic in Houston TX #### Event Groups **Group ID:** EG000 **Title:** Antineoplaston Therapy **Description:** Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal). **ID:** EG000 **Other Num Affected:** 9 **Other Num at Risk:** 9 **Serious Number Affected:** 5 **Serious Number At Risk:** 9 **Title:** Antineoplaston Therapy **Frequency Threshold:** 5 #### Other Events **Term:** Allergic reaction/hypersensitivity (including drug fever) **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Immune system disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Hemoglobin **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Leukocytes (total WBC) **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Lymphopenia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Neutrophils/granulocytes (ANC/AGC) **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Central venous catheter infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** Institutional **Term:** Non-functional central venous catheter **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** Institutional **Term:** Fatigue (asthenia, lethargy, malaise) **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Fever **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Insomnia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Rigors/chills **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Weight gain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Pruritus/itching **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Rash: erythema multiforme **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Edema/Fluid retention **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** Institutional **Term:** Diarrhea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Nausea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Vomiting **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Hemorrhage, GU: Bladder **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Pancreatitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Infection (documented clinically): Bladder (urinary) **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** CTCAE (3.0) **Term:** Infection (documented clinically): Blood **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** CTCAE (3.0) **Term:** Infection (documented clinically): Mucosa **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** CTCAE (3.0) **Term:** Infection (documented clinically): Pharynx **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** CTCAE (3.0) **Term:** Infection (documented clinically): Sinus **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** CTCAE (3.0) **Term:** Infection (documented clinically): Soft tissue NOS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** CTCAE (3.0) **Term:** Infection (documented clinically): Urinary tract NOS **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** CTCAE (3.0) **Term:** Middle ear (otitis media) **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** CTCAE (3.0) **Term:** Skin **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** CTCAE (3.0) **Term:** Upper airway **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** CTCAE (3.0) **Term:** Hyperglycemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** CTCAE (3.0) **Term:** Hypernatremia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** CTCAE (3.0) **Term:** Hyperuricemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** CTCAE (3.0) **Term:** Hypocalcemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** CTCAE (3.0) **Term:** Hypochloremia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** CTCAE (3.0) **Term:** Hypoglycemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** CTCAE (3.0) **Term:** Hypokalemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** CTCAE (3.0) **Term:** Metabolic/Laboratory - Other **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** CTCAE (3.0) **Term:** Proteinuria **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** CTCAE (3.0) **Term:** SGOT **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** CTCAE (3.0) **Term:** SGPT **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** CTCAE (3.0) **Term:** Apnea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Ataxia (incoordination) **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Confusion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Dizziness **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Neuropathy: cranial: CN VIII Hearing and balance **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Neuropathy: sensory **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Seizure **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Somnolence/depressed level of consciousness **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Speech impairment **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Syncope (fainting) **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Pain: Dental/teeth/peridontal **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Pain: Head/headache **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Pain: Joint **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Pain: Stomach **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (3.0) **Term:** Dyspnea (shortness of breath) **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** CTCAE (3.0) #### Serious Events **Term:** Hemoglobin **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** The Hemoglobin was not related to Antineoplaston therapy. **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** CTCAE (Version 3 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 9 **Term:** Central venous catheter infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** The Central venous catheter infection was not related to Antineoplaston therapy. **Organ System:** Infections and infestations **Source Vocabulary:** Institutional ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 9 **Term:** Rash: erythema multiforme **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** The Rash: erythema multiforme was possibly related to Antineoplaston therapy. **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** CTCAE (3.0) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 9 **Term:** Pancreatitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** The Pancreatitis was not related to Antineoplaston therapy. **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (3.0) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 9 **Term:** Infection (documented clinically): Blood **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** The Infection (documented clinically): Blood was not related to Antineoplaston therapy. **Organ System:** Infections and infestations **Source Vocabulary:** CTCAE (3.0) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 9 **Term:** Hypokalemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** The Hypokalemia was possibly related to Antineoplaston therapy. **Organ System:** Investigations **Source Vocabulary:** CTCAE (3.0) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 9 **Term:** Confusion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** The Confusion was possibly related to Antineoplaston therapy. **Organ System:** Nervous system disorders **Source Vocabulary:** CTCAE (3.0) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 9 **Term:** Seizure **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** The Seizure was not related to Antineoplaston therapy. **Organ System:** Nervous system disorders **Source Vocabulary:** CTCAE (3.0) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 9 **Term:** Somnolence/depressed level of consciousness **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** The Somnolence/depressed level of consciousness was not related to Antineoplaston therapy. **Organ System:** Nervous system disorders **Source Vocabulary:** CTCAE (3.0) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 9 **Term:** Pain: Joint **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** The Pain: Joint was possibly related to Antineoplaston therapy. **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** CTCAE (3.0) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 9 **Term:** Pain: Stomach **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** The Pain: Stomach was not related to Antineoplaston therapy. **Organ System:** Gastrointestinal disorders **Source Vocabulary:** CTCAE (3.0) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 9 **Time Frame:** 4 years, 2 months ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 9 **Units:** Participants ### Group **ID:** BG000 **Title:** Antineoplaston Therapy **Description:** Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal). ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 1.6 **Upper Limit:** 35.7 **Value:** 7.3 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 5 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 4 **Category Title:** Male **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** FULL_RANGE **Parameter Type:** MEDIAN **Title:** Age, Continuous **Unit of Measure:** Years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** [email protected] **Organization:** Burzynski Research Institute, Inc. **Phone:** 713-335-5664 **Title:** S. R. Burzynski, MD, PhD ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 66.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 44.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 33.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 22.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 22.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 11.1 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), \>=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), \<50% decrease and \<25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), \>=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions. **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** 12 months **Title:** Number of Participants With Objective Response **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal). **ID:** OG000 **Title:** Antineoplaston Therapy #### Outcome Measure 2 **Description:** 6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival **Parameter Type:** NUMBER **Population Description:** All study subjects receiving any Antineoplaston therapy **Reporting Status:** POSTED **Time Frame:** 6 months, 12 months, 24 months, 36 months, 48 months, 60 months **Title:** Percentage of Participants Who Survived **Type:** SECONDARY **Unit of Measure:** Percentage of Participants ##### Group **Description:** Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal). **ID:** OG000 **Title:** Antineoplaston Therapy ### Participant Flow Module #### Group **Description:** Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal). **ID:** FG000 **Title:** Antineoplaston Therapy #### Period **Title:** Overall Study ##### Withdraw **Type:** Not evaluable ###### Reason **Group ID:** FG000 **Number of Subjects:** 3 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 9 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 6 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 3 **Recruitment Details:** Nine patients were recruited between July 1996 and October 2000. All study subjects were seen at the Burzynski Clinic in Houston TX. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT04865679 **Acronym:** REPOSE-XL℠ **Brief Title:** Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends **Official Title:** Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends #### Organization Study ID Info **ID:** CAP-CP-002 #### Organization **Class:** INDUSTRY **Full Name:** Axogen Corporation #### Secondary ID Infos **Domain:** Department of Defense **ID:** CDMRP-OR180222 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2024-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-08-21 **Type:** ACTUAL **Last Update Submit Date:** 2023-08-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-11 **Type:** ESTIMATED #### Start Date **Date:** 2022-03-02 **Type:** ACTUAL **Status Verified Date:** 2023-08 #### Study First Post Date **Date:** 2021-04-29 **Type:** ACTUAL **Study First Submit Date:** 2021-04-22 **Study First Submit QC Date:** 2021-04-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Axogen Corporation #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This pilot study evaluates the tolerability and feasibility of the Axoguard Large-Diameter Nerve Cap (sizes 5-7 mm) for protecting and preserving terminated nerve endings after limb trauma or amputation when immediate attention to the nerve injuries is not possible. ### Conditions Module **Conditions:** - Symptomatic Neuroma - Amputation - Chronic Nerve Pain **Keywords:** - Peripheral Nerve Injuries - Peripheral Nervous System Disease - Neuroma - Nerve Pain - Nervous System Diseases - Trauma - Nervous System - Amputation - Nerve Repair - Surgical Treatment of Pain ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 15 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Active Comparator: Porcine derived extracellular matrix (ECM) based Nerve Termination Device Implantation of appropriate diameter of Axoguard Nerve Cap® (sizes 5-7 mm) at the time of surgery **Intervention Names:** - Device: Axoguard Nerve Cap® **Label:** Axoguard Nerve Cap® **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Axoguard Nerve Cap® **Description:** Entubulation of the nerve stump into the Axoguard Nerve Cap® following surgical excision of symptomatic neuroma **Name:** Axoguard Nerve Cap® **Type:** DEVICE ### Outcomes Module #### Other Outcomes **Description:** Nerve end size as measured by MRI or CT scan prior to required secondary TMR or RPNI procedure recorded in cubic millimeters (mm3). **Measure:** Nerve End Size Measurements **Time Frame:** Prior to Secondary Surgery (if performed) **Description:** Explanted tissue will be cut into thin slices, affixed to microscope slides, and stained with Hematoxylin and Eosin (H\&E), Masson's Trichrome (MT) and Neurofilament 200 (NF200) to allow for histological evaluation of axonal swirling, nerve cap remodeling, and overall tissue response. **Measure:** Histological Assessment of Explanted Nerve Cap After Secondary Procedure **Time Frame:** Following Explant (if performed) #### Primary Outcomes **Description:** The primary safety endpoint will monitor the nature and incidence of AE's, SAE's and/or UADE's associated with an unplanned revision procedure prior to the planned Targeted Muscle Reinnervation (TMR) or Regenerative Peripheral Nerve Interface (RPNI) starting from implantation (operative day) through 15 months depending on whether or not the subject undergoes the secondary TMR or RPNI procedure. **Measure:** Safety: Adverse Events (AEs), Serious Adverse Events (SAEs), or Unanticipated Adverse Device Effects (UADEs) **Time Frame:** 15 Months #### Secondary Outcomes **Description:** The Visual Analog Scale (VAS) For Pain is a patient reported outcomes scale whereby the patient indicates his/her current pain level by making a mark on a continuous horizontal 10-centimeter (100 millimeter) line. The distance from the 0 millimeter to the patient's mark corresponds to the amount of pain the subject is currently experiencing. VAS for Pain data are recorded as the number of millimeters from the left of the line to the patients mark across the range of 0-100 millimeters, with 0 millimeter representing no pain and 100 millimeters representing "the worst pain imaginable". Final VAS score will be collected either just prior to TMR or RPNI procedure or 12- months post op if subject will not undergo the secondary TMR or RPNI procedure **Measure:** Change in Visual Analog Scale (VAS) For Pain Score through TMR procedure or 12 post-operative months compared to baseline **Time Frame:** Week 2, 1, 3, 6, 9 and 12 months **Description:** The Patient Reported Outcome Measurement Information System (PROMIS®) - Pain Related Measures is a set of person-centered measures that evaluates and monitors a patient's physical health and pain. The pain related measures include domains evaluating fatigue, pain intensity, pain interference, sleep Disturbance, and Pain Behavior. Short forms containing fixed sets of 4-10 items or questions are included for each domain. All PROMIS scores are presented as T-scores where the T-score is the standardized score with a mean of 50 (range 20-80) and a standard deviation of 10. Higher scores indicate more of the concept being measured where sometimes the concept is desirable (e.g., physical function) and sometimes this it is undesirable (e.g., fatigue). Final PROMIS® Pain Related Measure will be collected either just prior to TMR or RPNI procedure or 12-months post op if subject will not undergo the secondary TMR or RPNI procedure. **Measure:** Change in Patient Reported Outcome Measurement Information System (PROMIS®) - Pain Related Measures through TMR or RPNI procedure or 12 post operative months compared to baseline **Time Frame:** Week 2, 1, 3, 6, 9 and 12 months **Description:** In this study, the Work Productivity and Activity Impairment (WPAI:SHP) questionnaire is an instrument to measure impairments in both paid work and unpaid work (leisure/regular activities) due nerve injury post-surgical intervention. It measures (1) absenteeism (work time missed), (2) presenteeism (impairment at work / reduced on-the-job effectiveness), (3) work productivity loss (overall work impairment / absenteeism plus presenteeism), as well as the (4) impairments in unpaid activity because of nerve injury post-surgical intervention during the past seven days. Scores for these 4 measures are expressed as impairment percentages with higher percentage scores indicating greater impairment in than lower percentage scores. Final WPAI:SHP will be collected either at the office visit following the TMR or RPNI procedure or 12-months post op if subject will not undergo the secondary TMR or RPNI procedure **Measure:** Change in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) through TMR or RPNI procedure or 12 post-operative months compared to baseline **Time Frame:** Week 2, 1, 3, 6, 9 and 12 months **Description:** The BAM-ULA is a 10-item observational measure of activity performance. The 10 items are as follows: tuck a shirt in pants, lift a 20-lb bag, open a water bottle, remove a wallet from back pocket, replace the wallet in back pocket, take a gallon of water from the refrigerator and place on the counter (lift gallon jug), pour water from a gallon jug, brush or comb hair, use a fork, and open a door with knob. Items are scored with either a 0 (cannot complete all subtasks) or 1 (can complete all subtasks). Lower scores area associated with greater impairment of activity performance and higher scores are associated with less impairment of activity performance. **Measure:** Change in Brief Activities Measure for Adults with Upper Limb Amputation (BAM-ULA) through 12 post-operative months compared to baseline **Time Frame:** 3, 6, 9 and 12 months **Description:** An observational test used to evaluate functional mobility in terms of postural stability, gait, stride length, and sway. Patients wear their regular footwear and can use a walking aid. They are asked to sit in a chair, stand up from that chair, walk to a line on the floor (10 ft. away) at their normal pace, turn around, walk back to the chair at a normal pace, and sit down again. **Measure:** Change in Timed Up and Go (TUG) Test for Lower Extremity Amputees through 12 post-operative months compared to baseline **Time Frame:** 3, 6, 9 and 12 months **Description:** A performance measure used evaluate functional mobility and gait. It assesses walking speed in meters per second over 10-meter distance. **Measure:** Change in the 10-Meter Walk Test (10 MWT) for Lower Extremity Amputees through 12 post-operative months compared to baseline **Time Frame:** 3, 6, 9 and 12 months **Description:** Quantity and class of pain medication use for subjects who were implanted with the Axoguard Nerve Cap® will be captured during the following visits: Screening (baseline), 2-weeks, 1, 3, 6, 9, 12, and 15 months post-op for comparison to baseline. **Measure:** Changes in quantity and class of pain medication use at week 2, 1, 3, 6, 9, 12, and 15 post-operative months comparted to baseline **Time Frame:** Week 2, 1, 3, 6, 9, 12, and 15 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Potential Subjects MUST: 1. Sign and date an IRB-approved written Informed Consent Form prior to initiation of any study procedures; 2. Be an adult male or female ≥ 18 and ≤ 80 years of age; 3. Present for surgery with either: 1. Limb trauma and/or planned amputation of a limb and be candidates who are planned for a secondary nerve surgery such as Targeted Muscle Reinnervation (TMR) or Regenerative Peripheral Nerve Interface (RPNI) procedures within 6-12 months from time of amputation, or; 2. A previous amputation and be undergoing surgery to address nerve ends; 4. Have at least one nerve end measuring greater than 4 mm and less than 7 mm in diameter after debridement and hemostasis of the proximal nerve stump; 5. Have sufficient soft tissue available to be adequately covered by the Axoguard Nerve Cap; 6. Be willing and able to comply with all aspects of the treatment and follow-up assessments and to return for all required study visits throughout the study duration. Exclusion Criteria: Potential Subjects MUST NOT: 1. Currently undergoing or are expected to undergo treatment with chemotherapy, radiation therapy, or other known treatment that affects the growth of neural and/or vascular tissues; 2. Have signs and symptoms of chemotherapy-induced peripheral neuropathy from previous chemotherapy; 3. Be immunosuppressed or have planned immunosuppressive therapy during the duration of the study; 4. Current uncontrolled local or systemic infection as indicated by positive blood culture or other pathological indicators of infection; 5. Be contraindicated for soft tissue implants. This includes but is not limited to any pathology that would limit the blood supply to the target area or otherwise compromise healing; 6. Have a life expectancy of less than 15-months; 7. Have a history of or be planning to undergo radiotherapy in the area of the end-neuroma; 8. Have bony exostosis of the affected limb that is not treated at the time of nerve cap placement; 9. Have uncontrolled Type 1 or Type 2 Diabetes Mellitus with HbA1c of 8% or greater or those with diabetic neuropathy in the target area or proximal to the amputation site; 10. Have a history of idiopathic neuropathy/radiculopathy, known sciatica or chronic back pain; 11. Documented history of centralized nerve pain that does not respond to a peripheral nerve block in the affected limb; 12. Have a known allergy to anesthetic agents; 13. Have a known sensitivity to porcine-derived products; 14. Be currently enrolled or have been enrolled in another interventional clinical research study within the past 30 days (at time of consent); or 15. Be deemed unsuitable for inclusion in the study at the discretion of the investigator. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ray A Rivera, MD **Phone:** 386-462-6841 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Kyle Icke, PhD **Role:** CONTACT #### Locations **Location 1:** **City:** Boston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ian Valerio, MD - **Phone:** 617-726-2000 - **Role:** CONTACT ***Contact 2:*** - **Name:** Ian Valerio, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Massachusetts General Hospital **State:** Massachusetts **Status:** RECRUITING **Zip:** 02114 **Location 2:** **City:** Lubbock **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Brendan MacKay, MD - **Phone:** 806-743-3520 - **Role:** CONTACT ***Contact 2:*** - **Name:** Brendan MacKay, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Texas Tech University, Health Science Center **State:** Texas **Status:** RECRUITING **Zip:** 79430 ### IPD Sharing Statement Module **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Ancestors - ID: D000018317 - Term: Nerve Sheath Neoplasms - ID: D000009380 - Term: Neoplasms, Nerve Tissue - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000010523 - Term: Peripheral Nervous System Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC04 - Name: Neoplasms - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M13432 - Name: Peripheral Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M29440 - Name: Peripheral Nerve Injuries - Relevance: LOW - As Found: Unknown - ID: M12406 - Name: Neuroma - Relevance: HIGH - As Found: Neuroma - ID: M12381 - Name: Neuralgia - Relevance: HIGH - As Found: Nerve Pain - ID: M20461 - Name: Nerve Sheath Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12325 - Name: Neoplasms, Nerve Tissue - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009463 - Term: Neuroma - ID: D000009437 - Term: Neuralgia ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00752479 **Acronym:** MSC-KTX **Brief Title:** Mesenchymal Stem Cells Under Basiliximab/Low Dose RATG to Induce Renal Transplant Tolerance **Official Title:** Mesenchymal Stem Cells Under Basiliximab/Low Dose RATG to Induce Renal Transplant Tolerance #### Organization Study ID Info **ID:** MSC KTX #### Organization **Class:** OTHER **Full Name:** Mario Negri Institute for Pharmacological Research #### Secondary ID Infos **ID:** 2009-012350-20 **Type:** EUDRACT_NUMBER ### Status Module #### Completion Date **Date:** 2013-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-12-04 **Type:** ACTUAL **Last Update Submit Date:** 2023-11-28 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2013-07 **Type:** ACTUAL #### Start Date **Date:** 2008-05 **Status Verified Date:** 2015-04 #### Study First Post Date **Date:** 2008-09-15 **Type:** ESTIMATED **Study First Submit Date:** 2008-07-23 **Study First Submit QC Date:** 2008-09-12 **Why Stopped:** Necessity of major revision of the protocol ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mario Negri Institute for Pharmacological Research #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** This a pilot, explorative study to define the safety and biological/mechanistic effect of the systemic intravenous infusion of syngeneic ex-vivo expanded MSCs in living-related kidney transplant recipients (one or two HLA haplotype mismatches) under basiliximab/low-dose RATG induction therapy and maintenance immunosuppressive drugs with the ultimate objective to test the feasibility of safely achieving graft tolerance in a subsequent efficacy pilot study. Specific objectives To compare changes in the immunophenotype and ex-vivo T-cell functional tests from samples of peripheral blood and measurement in the urine of messenger RNA for FoxP3,in kidney transplant recipients given or not syngeneic (from the recipient) MSC infusion under basiliximab/low-dose RATG induction therapy and maintenance immunosuppressive treatment with low-dose cyclosporine (CsA) plus low-dose mycophenolate mofetil (MMF). This will assess at different time up to 12 months post transplant. In addition the safety profile of MSC infusion will be investigated. We have planned to start with the safety and biological/mechanistic study in 6 living-related kidney transplant recipients. Three patients will receive ex-vivo expanded syngeneic MSC infusion (2x106 MSCs per kilogram body weight) at the time of kidney transplant, and 3 additional patients no cells (controls), both under the cover of induction therapy with basiliximab and low-dose RATG, and maintenance immunosuppression with low-dose CsA and MMF. Randomization to MSC or no cell infusion will be performed at the time the recipient will sign the informed consent to participate to the study. Should this biological/mechanistic ex vivo studies document that MSC infusion allows the development of an immune microenvironment permissive to graft tolerance, a pilot efficacy study to achieve operational tolerance after complete withdrawal of maintenance immunosuppressive therapy will follow. In this additional pilot explorative efficacy study all consecutive patients will be included and followed until the first episode of rejection (if any) will occur or 29 consecutive patients have successfully withdrawn the immunosuppressive therapy. This has been estimated according to the Simon's two-stage minimax design. **Detailed Description:** INTRODUCTION In organ transplantation the immunosuppressive drugs have dramatically improved the life of transplant recipients over the past 30 years, but two notable problems remain:drug-associated toxicities, and failure of these drugs to prevent chronic graft dysfunction and extend long-term graft survival. Given these circumstances, the scientific discussion is dominated by designing effective ways to induce transplantation tolerance. 'Transplantation tolerance' describes a state in which a donor is 'accepted' without chronic immunosuppressive therapy, while the remainder of the immune system is left intact. Thus, lack of a pathogenic response to the alloantigen is specific, and the recipient is capable of responding to potentially pathogenic microorganisms and malignancies. There is abundant evidence for active immunoregulatory mechanisms, which may operate to maintain transplant tolerance. The problems of immunosuppressive drug toxicity could be alleviated by induction of immune tolerance.Over the last 25 years, several strategies have been used successfully to induce transplantation tolerance. Each of these has been validated in at least one rodent model, with varying degrees of success upon extension to large animals, including nonhuman primates. Very small minorities of patients, who discontinue their immunosuppression, provide rare examples of clinical transplantation tolerance. To this purpose, mesenchymal stem cell (MSC) infusion could represent a novel tolerogenic cell therapy in kidney transplantation. Human bone marrow stem cells, more recently referred to as MSCs, are multipotential cells that reside within the bone marrow and can differentiate into various components of the marrow microenvironment, in addition to supporting growth of hematopoietic progenitors.There is also evidence that MSCs escape the immune system, and therefore could be infused into an allogeneic host without being rejected and without requirement of conditioning regimens. Moreover, they exert an immunoregulatory activity, although the exact mechanism of action is unknown. On this line, evidence is available that MSC inhibit naïve T cells and lock dendritic cells (DC) into a semi-mature state, thereby favoring peripheral tolerance. It should be also pointed out that experimental in vitro evidence has shown that mouse MSCs inhibit the response of memory antigen-specific T cells to their cognate peptide. We expect that, in kidney transplant recipients, MSC infusion would allow inhibition of alloantigen-specific memory T cell response contributing to long-term graft survival. Moreover in vitro studies have documented that the CD4+CD25+ T regulatory cell population increased significantly in MLR when human MSCs were present compared to controls without MSCs. These findings suggest that MSC may modulate T cell response even through a regulatory mechanism. Furthermore an immunosuppressive effect of MSCs in vivo has been shown in a baboon model, in which infusion of ex-vivo expanded matched donor or third-party MSCs delayed the time to rejection of histoincompatible skin graft. The immunomodulatory function of MSCs has been also documented in preliminary in vivo studies in humans, where cell infusion did exert preventive effects on the development of acute and chronic GVHD. Thus, although no data so far are available in human kidney transplantation, we expect that peri-transplant intravenous infusion of syngeneic ex-vivo expanded MSCs under peripheral T-cell depletion/blockade with basiliximab and low dose RATG (as induction therapy) and the cover of low dose maintenance immunosuppressive drugs would allow to safety achieving graft tolerance in living-related kidney transplant recipients. This could be through inhibition of both naïve and memory T cells, and promotion of development and activation of regulatory T cells, eventually leading to indefinite graft survival. Up to now there is no clinical study that MSC infusion has an immunomodulatory effect in patients undergoing kidney transplant. Nevertheless, there are clinical data on the effectiveness and safety of MSC infusion in other diseases/conditions. The general aim of the present study is to test a cell therapy with syngeneic ex vivo expanded MSC as a strategy to induce tolerance in living-related kidney transplant recipients. MSC will be prepared accordingly to established protocols, starting from bone marrow explants of living-related recipients obtained 3-4 months before kidney transplant. From these samples, MSC will be expanded in vitro and used for the present study in patients undergoing kidney transplantation. AIMS AND STUDY DESIGN This a pilot, explorative study to define the safety and biological/mechanistic effect of the systemic intravenous infusion of syngeneic ex-vivo expanded MSCs in living-related kidney transplant recipients (one or two HLA haplotype mismatches) under basiliximab/low-dose RATG induction therapy and maintenance immunosuppressive drugs with the ultimate objective to test the feasibility of safely achieving graft tolerance in a subsequent efficacy pilot study. Indeed, to complement the research with a clinical portion that document operational tolerance, a pilot efficacy study of safely achieving kidney graft tolerance after complete withdrawal of maintenance immunosuppressive therapy will follow pending on the fact that the results of biological/mechanistic tests will document that MSC infusion allows the development of an immune microenvironment permissive to graft tolerance. Specific objectives To compare changes in the immunophenotype and ex-vivo T-cell functional tests from samples of peripheral blood and measurement in the urine of messenger RNA for FoxP3,in kidney transplant recipients given or not syngeneic (from the recipient) MSC infusion under basiliximab/low-dose RATG induction therapy and maintenance immunosuppressive treatment with low-dose cyclosporine (CsA) plus low-dose mycophenolate mofetil (MMF). In particular, at different time up to 12 months post transplant, the plan is the following: Immunophenotyping 1. To assess the effect of the treatment on absolute and percent count of circulating CD4+, CD8+ T cells (and the CD4/CD8 ratio), B cells and NK cells. 2. To examine whether changes in circulating naïve and memory T cell count may occur (CD45RA/CD45RO). 3. To characterize the emergence in the circulation of T cell subpopulations with immunoregulatory phenotype (CD4+CD25highFOXP3+; CD8+CD28-, CD3-CD56bright). Lymphocyte functional assays 1. To detect whether donor-specific hyporesponsiveness develops post-operatively by monitoring T cell activation in response to alloantigen stimulation by mixed lymphocyte reaction (MLR), by ELISPOT assay for IFN-gamma and by cell-mediated lympholysis (CML). 2. To determine whether T cell deletion/anergy develops by repeating T cell stimulation in MLR and in IFN-gamma ELISPOT assay in the presence of high doses of IL-2. 3. To monitor the regulatory properties of T cells circulating in the peripheral blood by in vitro proliferative assay, in particular of CD4+CD25high, CD8+CD28- T cells, and CD56bright NK cells. Urinary FOXP3 messenger RNA a)To evaluate whether measurement in urinary cells of mRNA level for FoxP3, a functional factor for regulatory T lymphocytes, may provide insight into the immunologic events within the renal allograft. In addition the safety profile of MSC infusion will be investigated. Should this biological/mechanistic ex vivo studies document that MSC infusion allows the development of an immune microenvironment permissive to graft tolerance, a pilot efficacy study to achieve operational tolerance after complete withdrawal of maintenance immunosuppressive therapy will follow. The criteria to document the development of a pro-tolerogenic microenvironment (at 12 months post-kidney transplant) are the followings: * Percentage of inhibition of memory T cell response (by IFN-gamma ELISPOT) and/or naïve T cell response (by MLR) versus donor antigens higher than 15-20% in patients receiving peri-transplant MSC infusion as compared to patients receiving the immunosuppressive therapy alone, in the context of normal immune responses versus third party antigens, mitogens (PHA) and recall antigens (mumps, pertussis). and * Induction of donor-reactive T cell anergy in a percentage higher than 15-20% in patients receiving peri-transplant MSC infusion as compared to those given the immunosuppressive therapy alone (evaluated by addition of high dose IL-2 in ELISPOT assay) or * Appearance in the peripheral blood of regulatory T cells in a percentage higher than 80% in patients receiving peri-transplant MSC infusion as compared to patients receiving the immunosuppressive therapy alone and reversal of the inhibition of donor-specific immune response (evaluated by depletion of specific regulatory cells in ELISPOT and/or MLR assays) in a percentage higher than 50% in MSC-treated as compared with non MSC-treated patients. We have planned to start with the safety and biological/mechanistic study in 6 living-related kidney transplant recipients. Three patients will receive ex-vivo expanded syngeneic MSC infusion at the time of kidney transplant, and 3 additional patients no cells (controls), both under the cover of induction therapy with basiliximab and low-dose RATG, and maintenance immunosuppression with low-dose CsA and MMF. Randomization to MSC or no cell infusion will be performed at the time the recipient will sign the informed consent to participate to the study. This will be when the patients fulfill all the criteria to enter the waiting list for kidney transplant from living donor. The first patient will receive a single i.v infusion of syngeneic MSC (2x106 MSCs per kilogram body weight). If the procedure is safe and no major adverse events related to the i.v cell infusion will occur within the first month (early peri-infusion side effects, severe infections possibly due to over-immunosuppression), the second patients will be enrolled. Should the procedure be safe also in this case, the third kidney transplant patient will be enrolled and undergo syngeneic MSC infusion. To complement this research with a clinical portion that document operational tolerance, a pilot efficacy study of safely achieving kidney graft tolerance after complete withdrawal of maintenance immunosuppressive therapy will follow pending on the fact that the results of biological/mechanistic tests (at 12 months post-transplant) will document that MSC infusion allows the development of an immune microenvironment permissive to graft tolerance, as higher inhibition of donor specific memory T cells and/or higher generation of alloantigen-specific regulatory T cells than the drug immunosuppressive treatment alone. In this additional pilot explorative efficacy study all consecutive patients will be included and followed until the first episode of rejection (if any) will occur or 29 consecutive patients have successfully withdrawn the immunosuppressive therapy. This has been estimated according to the Simon's two-stage minimax design. ### Conditions Module **Conditions:** - Kidney Transplant **Keywords:** - living - related ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 4 **Type:** ACTUAL **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Biological: Mesenchymal stem cells infusion, Basiliximab,Methylprednisolone,RATG ,Cyclosporine ,Mycophenolate mofetil **Label:** 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Basiliximab, Methylprednisolone,RATG,Cyclosporine,Mycophenolate mofetil **Label:** 2 **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - 1 **Description:** Cell therapy Mesenchymal cells infusion. Induction therapy: Basiliximab (20 mg i.v.day 0 and day 4 post-tx). Low dose RATG (0.5 mg/kg/day i.v. day 0-6 post-tx). Methylprednisolone (500 mg to 25 mg from day 0 to 6 post-tx. Then stop). Maintenance therapy: Cyclosporine (from day 0: dose according to target trough blood level). Mycophenolate mofetil (750 mg b.i.d. from day 1 post-tx). **Name:** Mesenchymal stem cells infusion, Basiliximab,Methylprednisolone,RATG ,Cyclosporine ,Mycophenolate mofetil **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - 2 **Description:** Routine immunosuppressive therapy Induction therapy: Basiliximab (20 mg i.v.day 0 and day 4 post-tx). Low dose RATG (0.5 mg/kg/day i.v. day 0-6 post-tx). Methylprednisolone (500 mg to 25 mg from day 0 to 6 post-tx. Then stop). Maintenance therapy: Cyclosporine (from day 0: dose according to target trough blood level). Mycophenolate mofetil (750 mg b.i.d. from day 1 post-tx). **Name:** Basiliximab, Methylprednisolone,RATG,Cyclosporine,Mycophenolate mofetil **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Assessing the percentage of inhibition of memory T cell response and/or naive T cell response, the induction of donor-reactive T cell anergy and the appearance in the peripheral blood of regulatory T cells. **Time Frame:** at 12 months post-kidney transplant #### Secondary Outcomes **Measure:** Safety parameters related to MSC infusion, graft function, graft rejection **Time Frame:** at 12 months post-kidney transplant ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male and female patients * Aged 18 or older * Non-HLA identical with the donor (one or two haplotype mismatches) * First kidney transplant * Capable of understanding the purpose and risk of the study * Written informed consent Exclusion Criteria: * MSC donor positive for HIV-1, HIV-2, HBV, HCV, Syphilis. * Specific contraindication to MSC infusion * Any clinical relevant condition that might affect study participation and/or study results * Pregnant women and nursing mothers * Unwillingness or inability to follow study protocol in the investigator's opinion **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bergamo **Country:** Italy **Facility:** Nephrology Unit **State:** BG **Zip:** 24128 #### Overall Officials **Official 1:** **Affiliation:** Department of Immunology and Clinical Transplantation / Mario Negri Institute for Pharmacological Research and Ospedali Riuniti BG **Name:** Giuseppe Remuzzi, MD **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** Mario Negri Institute for Pharmacological Research, Ranica BG **Name:** Norberto Perico, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** Mario Negri Institute for Pharmacological Research, Ranica BG **Name:** Marina Noris, CH Ph **Role:** PRINCIPAL_INVESTIGATOR **Official 4:** **Affiliation:** Cell and Gene therapy Laboratory "G. Lanzani" BG **Name:** Martino Introna, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 5:** **Affiliation:** Hematology Unit - Ospedali Riuniti BG **Name:** Alessandro Rambaldi, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Perico N, Casiraghi F, Todeschini M, Cortinovis M, Gotti E, Portalupi V, Mister M, Gaspari F, Villa A, Fiori S, Introna M, Longhi E, Remuzzi G. Long-Term Clinical and Immunological Profile of Kidney Transplant Patients Given Mesenchymal Stromal Cell Immunotherapy. Front Immunol. 2018 Jun 14;9:1359. doi: 10.3389/fimmu.2018.01359. eCollection 2018. **PMID:** 29963053 **Citation:** Perico N, Casiraghi F, Gotti E, Introna M, Todeschini M, Cavinato RA, Capelli C, Rambaldi A, Cassis P, Rizzo P, Cortinovis M, Noris M, Remuzzi G. Mesenchymal stromal cells and kidney transplantation: pretransplant infusion protects from graft dysfunction while fostering immunoregulation. Transpl Int. 2013 Sep;26(9):867-78. doi: 10.1111/tri.12132. Epub 2013 Jun 6. **PMID:** 23738760 **Citation:** Perico N, Casiraghi F, Introna M, Gotti E, Todeschini M, Cavinato RA, Capelli C, Rambaldi A, Cassis P, Rizzo P, Cortinovis M, Marasa M, Golay J, Noris M, Remuzzi G. Autologous mesenchymal stromal cells and kidney transplantation: a pilot study of safety and clinical feasibility. Clin J Am Soc Nephrol. 2011 Feb;6(2):412-22. doi: 10.2215/CJN.04950610. Epub 2010 Oct 7. **PMID:** 20930086 ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000935 - Term: Antifungal Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000003879 - Term: Dermatologic Agents - ID: D000018501 - Term: Antirheumatic Agents - ID: D000065095 - Term: Calcineurin Inhibitors - ID: D000000903 - Term: Antibiotics, Antineoplastic - ID: D000000970 - Term: Antineoplastic Agents - ID: D000000904 - Term: Antibiotics, Antitubercular - ID: D000000995 - Term: Antitubercular Agents - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000000932 - Term: Antiemetics - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000005765 - Term: Gastrointestinal Agents - ID: D000005938 - Term: Glucocorticoids - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000018696 - Term: Neuroprotective Agents - ID: D000020011 - Term: Protective Agents - ID: D000018931 - Term: Antineoplastic Agents, Hormonal ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: AnEm - Name: Antiemetics - Abbrev: NeuroAg - Name: Neuroprotective Agents - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M18961 - Name: Cyclosporine - Relevance: HIGH - As Found: New - ID: M6730 - Name: Cyclosporins - Relevance: HIGH - As Found: New - ID: M14120 - Name: Prednisolone - Relevance: HIGH - As Found: Smoking - ID: M12128 - Name: Mycophenolic Acid - Relevance: HIGH - As Found: Mindfulness - ID: M11749 - Name: Methylprednisolone - Relevance: HIGH - As Found: Smoking - ID: M1830 - Name: Basiliximab - Relevance: HIGH - As Found: Chimeric Antigen Receptor - ID: M1833 - Name: Methylprednisolone Acetate - Relevance: HIGH - As Found: Smoking - ID: M11750 - Name: Methylprednisolone Hemisuccinate - Relevance: HIGH - As Found: Smoking - ID: M229449 - Name: Prednisolone acetate - Relevance: HIGH - As Found: Smoking - ID: M211887 - Name: Prednisolone hemisuccinate - Relevance: HIGH - As Found: Smoking - ID: M248881 - Name: Prednisolone phosphate - Relevance: HIGH - As Found: Smoking - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M255823 - Name: Thymoglobulin - Relevance: HIGH - As Found: Urticaria - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M6252 - Name: Clotrimazole - Relevance: LOW - As Found: Unknown - ID: M11796 - Name: Miconazole - Relevance: LOW - As Found: Unknown - ID: M4254 - Name: Antifungal Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M7074 - Name: Dermatologic Agents - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: M30452 - Name: Calcineurin Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M4311 - Name: Antitubercular Agents - Relevance: LOW - As Found: Unknown - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M4251 - Name: Antiemetics - Relevance: LOW - As Found: Unknown - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown - ID: M9047 - Name: Glucocorticoids - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M20773 - Name: Neuroprotective Agents - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown - ID: M20966 - Name: Antineoplastic Agents, Hormonal - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000016572 - Term: Cyclosporine - ID: D000009173 - Term: Mycophenolic Acid - ID: D000008775 - Term: Methylprednisolone - ID: D000077555 - Term: Methylprednisolone Acetate - ID: D000008776 - Term: Methylprednisolone Hemisuccinate - ID: D000011239 - Term: Prednisolone - ID: C000009935 - Term: Prednisolone acetate - ID: D000003524 - Term: Cyclosporins - ID: D000077552 - Term: Basiliximab - ID: C000512542 - Term: Thymoglobulin - ID: C000021322 - Term: Prednisolone hemisuccinate - ID: C000009022 - Term: Prednisolone phosphate ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04430179 **Brief Title:** Dupilumab Severe Eosinophilic Chronic Sinusitis Without Nasal Polyposis **Official Title:** An Evaluation of Dupilumab in Patients With Severe Eosinophilic Chronic Sinusitis Without Nasal Polyposis #### Organization Study ID Info **ID:** STUDY000808 #### Organization **Class:** OTHER **Full Name:** University of South Florida ### Status Module #### Completion Date **Date:** 2023-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2022-11-15 **Type:** ACTUAL **Last Update Submit Date:** 2022-11-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2023-07 **Type:** ESTIMATED #### Start Date **Date:** 2020-12-17 **Type:** ACTUAL **Status Verified Date:** 2022-11 #### Study First Post Date **Date:** 2020-06-12 **Type:** ACTUAL **Study First Submit Date:** 2020-04-13 **Study First Submit QC Date:** 2020-06-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of South Florida #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The investigators will investigate the efficacy of dupilumab in patients with severe eosinophilic CRSsNP who are resistant to the conventional treatment with intranasal corticosteroids and have significantly extensive disease involving more than 2 sinuses bilaterally in sinus CT scan and Lund-Mackay sinus (LMK) CT score \>=10 at baseline. **Detailed Description:** The investigators will use high blood eosinophils (\>=200) as a biomarker for eosinophilic CRSsNP and investigate the efficacy of dupilumab in patients with severe eosinophilic CRSsNP who are resistant to the conventional treatment with intranasal corticosteroids and have significantly extensive disease involving more than 2 sinuses bilaterally in sinus CT scan and Lund-Mackay sinus (LMK) CT score \>=10 at baseline. In addition, the investigators will have a prespecified enrollment goal of at least 50% of patients with type 2 inflammatory diseases such as asthma, allergic rhinitis, and/or atopic dermatitis on the basis of patient-reported history and will stratify subject numbers between dupilumab treatment and placebo group. ### Conditions Module **Conditions:** - Severe Eosinophilic Chronic Sinusitis Without Nasal Polyposis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Active drug vs placebo ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** Double-blinded **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Dupilumab 300 mg every other week for 24 weeks **Intervention Names:** - Drug: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] **Label:** Active drug **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Placebo **Intervention Names:** - Other: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Active drug **Description:** 300 mg every other week for 24 weeks **Name:** Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** No active drug **Name:** Placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Change in LMK-CT score in dupilumab group compared to control group. The total score ranges from 0 (normal) - 24 (more opacified): higher score indicates worse status. **Measure:** Change in Lund-Mackay sinus computed tomography (LMK-CT) score **Time Frame:** 24 weeks #### Secondary Outcomes **Description:** Change in baseline in participant-reported symptoms scores of sinusitis in dupilumab group compared to control group. Morning symptoms of sinusitis will be assessed using a 0 (no symptoms) - 3 (severe symptoms) categorical scale, where a higher score indicates severe symptoms. **Measure:** Change in participant-reported symptoms scores of sinusitis **Time Frame:** 24 weeks **Description:** Change in visual analogue scale score for sinusitis in dupilumab group compared to control group. the severity of sinusitis symptoms will be assessed on a 0 cm (not troublesome) - 10 cm (worst thinkable troublesome) where a higher score indicates worst thinkable troublesome. **Measure:** Change in visual analogue scale score for sinusitis **Time Frame:** 24 weeks **Description:** Change in nasal peak inspiratory flow in dupilumab group compared to placebo group. **Measure:** Change in nasal peak inspiratory flow **Time Frame:** 24 weeks **Description:** Change in UPSIT scores in dupilumab group compared to placebo group. Total score ranges from 0 (anosmia)-40 (normal sense of smell), a lower score indicates severe smell loss. **Measure:** Change in University of Pennsylvania smell identification test (UPSIT) scores **Time Frame:** 24 weeks **Description:** 50 percent improvement in LMK-CT score in dupilumab group compared to placebo group **Measure:** Time to first response in LMK-CT score **Time Frame:** 24 weeks **Description:** Change in 22-item SNOT-22 test score in dupilumab group compared to placebo group. The total score may range from 0 (no problem)-110 (worst quality of life), higher scores represent the worst quality of life; minimal clinically important change ≥ 8.90. **Measure:** Change in sinonasal outcome test (SNOT-22) score **Time Frame:** 24 weeks **Description:** Change in biomarkers concentrations in nasal secretion in dupilumab group compared to placebo group. ELISA will be done to measure biomarkers concentrations (pg/mL): ECP, IL-4, IL-5, IL-13, periostin, eotaxin-3, TARC, and IgE **Measure:** Change in biomarkers concentrations in nasal secretion measured by enzyme-linked immunosorbent assay (ELISA) **Time Frame:** 24 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 18 or older * LMK-CT score ≥ 10 (out of maximum of 24) at screening. * Bilateral sinusitis with at least more than 2 sinus involvement despite completion of a prior intranasal corticosteroid (INCS) treatment for at least 8 weeks prior to screening * Presence of at least two of the following symptoms prior to screening: * Nasal blockage/obstruction/congestion * Nasal discharge (anterior/posterior nasal drip) * Facial pain/pressure * Reduction or loss of smell * Must have Eosinophilic CRSsNP (blood eos ≥ 200) within 6 months prior to screening * Able and willing to undergo regular intervention as well as evaluation per study protocol * Must agree not to participate in a clinical study involving another investigational drug or device throughout the duration of this study * Must be competent to understand the information given in IRB approved ICF and must sign the form prior to the initiation of any study procedure Exclusion Criteria: * Age \< 18 * With CRS with nasal polyps * Treated in any clinical trial of dupilumab * Has taken: 1. Biologic therapy/systemic immunosuppressant to treat inflammatory disease or autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc) within 2 months before screening or 5 half-lives, whichever is longer 2. An experimental monoclonal antibody within five half-lives or within 6 months before screening if the half-life is unknown 3. Anti-immunoglobulin E (IgE) therapy (omalizumab) within 130 days prior to screening 4. Leukotriene antagonists/modifiers unless patient is on a continuous treatment for at least 30 days prior to screening 5. Initiation of allergen immunotherapy within 3 months prior to screening or a plan to begin therapy or change its dose during the run-in period or the randomized treatment period * Have had a sino-nasal surgery changing the lateral wall structure of the nose making impossible the evaluation of NPS * Patients with conditions/concomitant diseases making them non-evaluable at screening or for the primary efficacy endpoint such as: 1. Antrochoanal polyps 2. Nasal septal deviation that would occlude at least one nostril 3. Acute sinusitis, nasal infection or upper respiratory infection at screening 4. Ongoing rhinitis medicamentosa 5. Allergic granulomatous angiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), Young's syndrome, Kartagener's syndrome or other dyskinetic ciliary syndromes, concomitant cystic fibrosis 6. Radiologic suspicion, or confirmed invasive or expansive fungal rhinosinusitis * With co-morbid asthma are excluded if forced expiratory volume (FEV1) is 50% (of predicted normal) or less * With known active bacterial, viral, fungal, mycobacterial infection, or other infection or any major episode of infection that required hospitalization or treatment with IV antibiotics within 30 days of screening or during screening or oral antibiotics within 14 days prior to screening. Fungal infection of nail beds is allowed * Have human immunodeficiency virus/acquired immune deficiency syndrome * Have acute or chronic hepatitis B/hepatitis C infection * History of an opportunistic infection (eg, pneumocystis carinii, cryptococcal meningitis, progressive multifocal leukoencephalopathy) or serious bacterial, viral, or fungal infections (eg, disseminated herpes simplex, disseminated herpes zoster) and requiring IV medication(s) ≤ 3 weeks prior to randomization * History of or currently active primary or secondary immunodeficiency * History of cancer within the last 5 years, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved) or colonic mucosal dysplasia * History of lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorder, or multiple myeloma * History of alcohol or drug abuse within 1 year prior to randomization * Receipt of live vaccine within 4 weeks prior to randomization * Pregnant or breastfeeding * Participation in another clinical study or treatment with an investigational drug or device * Serious or active medical or psychiatric condition which, in the opinion of the Investigator, may interfere with treatment, assessment, or compliance with the protocol **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Thanh Q Tran, MPH **Phone:** 813-844-8544 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Catherine Smith **Phone:** 813-631-4024 **Phone Ext:** 207 **Role:** CONTACT #### Locations **Location 1:** **City:** Tampa **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Catherine Smith - **Phone:** 813-631-4024 - **Phone Ext:** 207 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Tiffani Kaage - **Phone:** 813-631-4024 - **Phone Ext:** 200 - **Role:** CONTACT ***Contact 3:*** - **Name:** Seong Cho, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Richard F Lockey, MD - **Role:** SUB_INVESTIGATOR ***Contact 5:*** - **Name:** Thomas B Casale, MD - **Role:** SUB_INVESTIGATOR ***Contact 6:*** - **Name:** Dennis K Ledford, MD - **Role:** SUB_INVESTIGATOR ***Contact 7:*** - **Name:** Amber N Pepper, MD - **Role:** SUB_INVESTIGATOR ***Contact 8:*** - **Name:** Nicholas Kolinsky, DO - **Role:** SUB_INVESTIGATOR ***Contact 9:*** - **Name:** David Gubernick, MD - **Role:** SUB_INVESTIGATOR ***Contact 10:*** - **Name:** Stephanie Hudey, MD - **Role:** SUB_INVESTIGATOR ***Contact 11:*** - **Name:** Natalie Diaz-Cabrera, MD - **Role:** SUB_INVESTIGATOR ***Contact 12:*** - **Name:** Donya Imanirad, MD - **Role:** SUB_INVESTIGATOR ***Contact 13:*** - **Name:** Walaa Hamadi, MD - **Role:** SUB_INVESTIGATOR ***Contact 14:*** - **Name:** Leah Ishmael, DO - **Role:** SUB_INVESTIGATOR ***Contact 15:*** - **Name:** Silpa Taunk, MD - **Role:** SUB_INVESTIGATOR ***Contact 16:*** - **Name:** Sonia Mathew, MD - **Role:** SUB_INVESTIGATOR **Country:** United States **Facility:** University of South Florida Asthma, Allergy and Immunology **State:** Florida **Status:** RECRUITING **Zip:** 33613 #### Overall Officials **Official 1:** **Affiliation:** University of South Florida **Name:** Seong Cho, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Kim DY, Lee SH, Carter RG, Kato A, Schleimer RP, Cho SH. A Recently Established Murine Model of Nasal Polyps Demonstrates Activation of B Cells, as Occurs in Human Nasal Polyps. Am J Respir Cell Mol Biol. 2016 Aug;55(2):170-5. doi: 10.1165/rcmb.2016-0002RC. **PMID:** 27163839 **Citation:** Tokunaga T, Sakashita M, Haruna T, Asaka D, Takeno S, Ikeda H, Nakayama T, Seki N, Ito S, Murata J, Sakuma Y, Yoshida N, Terada T, Morikura I, Sakaida H, Kondo K, Teraguchi K, Okano M, Otori N, Yoshikawa M, Hirakawa K, Haruna S, Himi T, Ikeda K, Ishitoya J, Iino Y, Kawata R, Kawauchi H, Kobayashi M, Yamasoba T, Miwa T, Urashima M, Tamari M, Noguchi E, Ninomiya T, Imoto Y, Morikawa T, Tomita K, Takabayashi T, Fujieda S. Novel scoring system and algorithm for classifying chronic rhinosinusitis: the JESREC Study. Allergy. 2015 Aug;70(8):995-1003. doi: 10.1111/all.12644. Epub 2015 May 26. **PMID:** 25945591 **Citation:** Hu Y, Cao PP, Liang GT, Cui YH, Liu Z. Diagnostic significance of blood eosinophil count in eosinophilic chronic rhinosinusitis with nasal polyps in Chinese adults. Laryngoscope. 2012 Mar;122(3):498-503. doi: 10.1002/lary.22507. Epub 2012 Jan 17. **PMID:** 22252861 **Citation:** Ho J, Hamizan AW, Alvarado R, Rimmer J, Sewell WA, Harvey RJ. Systemic Predictors of Eosinophilic Chronic Rhinosinusitis. Am J Rhinol Allergy. 2018 Jul;32(4):252-257. doi: 10.1177/1945892418779451. Epub 2018 Jun 4. **PMID:** 29862828 **Citation:** Thwaites RS, Gunawardana NC, Broich V, Mann EH, Ahnstrom J, Campbell GA, Lindsley S, Singh N, Tunstall T, Lane DA, Openshaw PJ, Hawrylowicz CM, Hansel TT. Biphasic activation of complement and fibrinolysis during the human nasal allergic response. J Allergy Clin Immunol. 2018 May;141(5):1892-1895.e6. doi: 10.1016/j.jaci.2018.01.022. Epub 2018 Feb 7. No abstract available. **PMID:** 29427640 **Citation:** Hopkins C, Browne JP, Slack R, Lund VJ, Topham J, Reeves BC, Copley LP, Brown P, van der Meulen JH. Complications of surgery for nasal polyposis and chronic rhinosinusitis: the results of a national audit in England and Wales. Laryngoscope. 2006 Aug;116(8):1494-9. doi: 10.1097/01.mlg.0000230399.24306.50. **PMID:** 16885760 **Citation:** Gevaert P, Lang-Loidolt D, Lackner A, Stammberger H, Staudinger H, Van Zele T, Holtappels G, Tavernier J, van Cauwenberge P, Bachert C. Nasal IL-5 levels determine the response to anti-IL-5 treatment in patients with nasal polyps. J Allergy Clin Immunol. 2006 Nov;118(5):1133-41. doi: 10.1016/j.jaci.2006.05.031. Epub 2006 Sep 26. **PMID:** 17088140 **Citation:** Gevaert P, Calus L, Van Zele T, Blomme K, De Ruyck N, Bauters W, Hellings P, Brusselle G, De Bacquer D, van Cauwenberge P, Bachert C. Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma. J Allergy Clin Immunol. 2013 Jan;131(1):110-6.e1. doi: 10.1016/j.jaci.2012.07.047. Epub 2012 Sep 27. **PMID:** 23021878 **Citation:** Gevaert P, Van Bruaene N, Cattaert T, Van Steen K, Van Zele T, Acke F, De Ruyck N, Blomme K, Sousa AR, Marshall RP, Bachert C. Mepolizumab, a humanized anti-IL-5 mAb, as a treatment option for severe nasal polyposis. J Allergy Clin Immunol. 2011 Nov;128(5):989-95.e1-8. doi: 10.1016/j.jaci.2011.07.056. Epub 2011 Sep 28. **PMID:** 21958585 **Citation:** Benjamin MR, Stevens WW, Li N, Bose S, Grammer LC, Kern RC, Tan BK, Conley DB, Smith SS, Welch KC, Schleimer RP, Peters AT. Clinical Characteristics of Patients with Chronic Rhinosinusitis without Nasal Polyps in an Academic Setting. J Allergy Clin Immunol Pract. 2019 Mar;7(3):1010-1016. doi: 10.1016/j.jaip.2018.10.014. Epub 2018 Oct 25. **PMID:** 30368005 **Citation:** Wang X, Zhang N, Bo M, Holtappels G, Zheng M, Lou H, Wang H, Zhang L, Bachert C. Diversity of TH cytokine profiles in patients with chronic rhinosinusitis: A multicenter study in Europe, Asia, and Oceania. J Allergy Clin Immunol. 2016 Nov;138(5):1344-1353. doi: 10.1016/j.jaci.2016.05.041. Epub 2016 Jul 15. **PMID:** 27544740 **Citation:** Stevens WW, Peters AT, Tan BK, Klingler AI, Poposki JA, Hulse KE, Grammer LC, Welch KC, Smith SS, Conley DB, Kern RC, Schleimer RP, Kato A. Associations Between Inflammatory Endotypes and Clinical Presentations in Chronic Rhinosinusitis. J Allergy Clin Immunol Pract. 2019 Nov-Dec;7(8):2812-2820.e3. doi: 10.1016/j.jaip.2019.05.009. Epub 2019 May 22. **PMID:** 31128376 **Citation:** Han DH, Kim SW, Cho SH, Kim DY, Lee CH, Kim SS, Rhee CS. Predictors of bronchial hyperresponsiveness in chronic rhinosinusitis with nasal polyp. Allergy. 2009 Jan;64(1):118-22. doi: 10.1111/j.1398-9995.2008.01841.x. Epub 2008 Dec 17. **PMID:** 19120071 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000010254 - Term: Paranasal Sinus Diseases - ID: D000009668 - Term: Nose Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000010038 - Term: Otorhinolaryngologic Diseases - ID: D000007414 - Term: Intestinal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000012002 - Term: Rectal Diseases - ID: D000010610 - Term: Pharyngeal Neoplasms - ID: D000010039 - Term: Otorhinolaryngologic Neoplasms - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000009302 - Term: Nasopharyngeal Diseases - ID: D000010608 - Term: Pharyngeal Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000011127 - Term: Polyps - ID: D000020763 - Term: Pathological Conditions, Anatomical ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15657 - Name: Sinusitis - Relevance: HIGH - As Found: Sinusitis - ID: M12249 - Name: Nasal Polyps - Relevance: HIGH - As Found: Nasal Polyposis - ID: M17890 - Name: Colorectal Neoplasms - Relevance: HIGH - As Found: Polyposis - ID: M12254 - Name: Nasopharyngeal Neoplasms - Relevance: HIGH - As Found: Polyposis - ID: M14011 - Name: Polyps - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: HIGH - As Found: Chronic Sinusitis - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M13167 - Name: Paranasal Sinus Diseases - Relevance: LOW - As Found: Unknown - ID: M12604 - Name: Nose Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M12961 - Name: Otorhinolaryngologic Diseases - Relevance: LOW - As Found: Unknown - ID: M10448 - Name: Intestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M14844 - Name: Rectal Diseases - Relevance: LOW - As Found: Unknown - ID: M13517 - Name: Pharyngeal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12962 - Name: Otorhinolaryngologic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12253 - Name: Nasopharyngeal Diseases - Relevance: LOW - As Found: Unknown - ID: M13515 - Name: Pharyngeal Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012852 - Term: Sinusitis - ID: D000015179 - Term: Colorectal Neoplasms - ID: D000009303 - Term: Nasopharyngeal Neoplasms - ID: D000009298 - Term: Nasal Polyps - ID: D000002908 - Term: Chronic Disease ### Intervention Browse Module - Ancestors - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M4230 - Name: Antibodies, Monoclonal - Relevance: HIGH - As Found: 9-18 - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000911 - Term: Antibodies, Monoclonal ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02710279 **Acronym:** SADS-CS **Brief Title:** Response to Social Rejection in Suicidal Behavior **Official Title:** Response to Social Rejection in Suicidal Behavior #### Organization Study ID Info **ID:** 9615 #### Organization **Class:** OTHER **Full Name:** University Hospital, Montpellier #### Secondary ID Infos **Domain:** Agence Nationale de Sécurité des Médicaments **ID:** 2015-A01308-41 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2018-02-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-08-03 **Type:** ACTUAL **Last Update Submit Date:** 2022-08-02 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2018-02-15 **Type:** ACTUAL #### Start Date **Date:** 2016-02-19 **Type:** ACTUAL **Status Verified Date:** 2021-12 #### Study First Post Date **Date:** 2016-03-16 **Type:** ESTIMATED **Study First Submit Date:** 2016-03-11 **Study First Submit QC Date:** 2016-03-15 **Why Stopped:** difficulties in recruitment ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Montpellier #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Suicide is a major health problem that causes annually a million death worldwild. In the stress-vulnerability model, suicidal behavior (SB) results from the interaction between an individual's predisposition and stressful condition. We hypothesized that the sensitivity to social exclusion may represent a core component of the suicidal vulnerability Recent evidence also suggest that inflammatory mediators plays a critical role in SB. Furthermore, social stressors are particulary strong and specific triggers of inflammatory response. To sum up, patients carrying a suicidal vulnerability are expected to present greater responses to social rejection in terms of inflammatory activity and psychological pain. The aim of the study is to evaluate the psychological and inflammatory responses to a social stressor validated, the Trier Social Stress Test (TSST) . We will also investigate the moderating effect of childhood abuse, attachment, trait rejection sensitivity and social isolation. In the second part of the study, we will also investigate the prospective association between inflammatory responses induces by laboratory paradigms of social rejection and the occurrence of social distress, suicidal ideation and psychological pain in response to social exclusion events in real life (using ecological momentary assessment). **Detailed Description:** Over one year, we will recruit 140 female outpatients suffering from a major depressive episode with (n=70) and without any history of suicide attempt (n=70) from a specialized clinic for mood disorders and SB. First visit: clinical, biological and neuropsychological assessment Second visit: The TSST is a standardized laboratory psychosocial stress protocol that involves public speaking, role play, and mental arithmetic tasks in front of a panel of confederate judges. Blood samples will be obtained before the introduction to the TSST and immediately after and at + 30, + 60, + 90, and + 120 min. Self-ratings of emotional states, anxiety, anger and psychological pain will be completed at the same times. Third visit: Participants will be instructed to carry a smartphone with them for one week, and to record at each alarm signal daily life events, negative emotions, psychological pain, suicidal ideas, and specific attributions to these events. Participants will be signalled five times a day during the period. Subjects will be contacted by telephone halfway through the assessment period to monitor and encourage compliance. ### Conditions Module **Conditions:** - Unipolar Depression **Keywords:** - Psychiatry - Depressive disorder - Suicide ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 79 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Depressive patients with or without story of suicidal behavior will pass the TSST and will have a psychological assessment to complete with a questionnaire on their smartphone **Intervention Names:** - Behavioral: Trier Social Stress Test (TSST) - Device: smartphone **Label:** Depressive patients **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Depressive patients **Description:** For the TSST the participants are instructed to imagine having applied for their "dream job" and that they are now invited to a job interview. Three successive phases: (1) A preparation period (3 min), (2) a free speech: explain why you are the best candidate for the job (5 min), (3) a mental arithmetic complex task (5 min). The two tasks (task 2 and 3) are performed in front of a selection committee, three persons dressed in white lab coats, acting in a reserved manner and providing no facial or verbal feedback. Additionally, participants are told that they are video-taped and told that their performance will be evaluated. (in fact, there is no video-tape, just a false camera). After the TSST, patients have to answer to a questionnaire on their smartphone, 5 times a day during 7 days. **Name:** Trier Social Stress Test (TSST) **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Depressive patients **Name:** smartphone **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** comparaison of psychological pain response between group with personal history of suicid attempt and group without personal history of suicid attempt **Measure:** Psychological pain response to Trier Social Stress Test (TSST) assessed by visual analogic sale **Time Frame:** up to one week #### Secondary Outcomes **Description:** comparaison of blood markers of inflammation between groups **Measure:** Inflammatory response to TTST **Time Frame:** up to one week **Description:** comparaison of sacles scores (ESUL : loneliness scale and CTQ : childhood abuse scale) between groups on inflammatory markers **Measure:** Impact of loneliness and childhood abuse on inflammatory markers **Time Frame:** up to one week **Description:** comparaison of neuropsychological tests between groups on psychological pain assessed by visual analogic scale **Measure:** impact of neuropschychological function on psychological pain **Time Frame:** up to one week **Description:** comparaison between groups whether inflammatory / psychological pain reactivity to a single experimental episode of social rejection in the laboratory relates to real-world social experience. It consists on self-assessments (with a smartphone) by Likert scales (feelings of social disconnection or rejection during their most recent social interaction, mood, negative affects, suicidal ideation, psychological pain), 5 times per day during 7 days **Measure:** Social rejection assessed by likert scale in real life condition with a smartphone **Time Frame:** 7 days after the TSST ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Non specifics * Female * Between 18 and 65 years * Main diagnosis of unipolar major depressive episode (DSM-IV criteria) * Having signed informed consent * Able to understand nature, aims, and methodology oh the study * Specifics : * Having a personal history of suicidal behavior (group : depressed patient with history of SB) OR * Not Having personal history of suicidal behavior (group : depressed patient without history of SB) Exclusion criteria: * Inflammatory or intercurrent pathology * Lifetime history of schizophrenia, or schizoaffective or bipolar disorder, according to DSM-IV criteria; * Current diagnosis of substance abuse or dependence in the last year (excluding tobacco) * Current organic mental disorder or mental retardation, or severe comorbid medical condition * Participation in another clinical trial * Pregnancy * Not able to speak, read and understand French * Patient on protective measures (guardianship or trusteeship) **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Montpellier **Country:** France **Facility:** University Hospital of Montpellier **Zip:** 34295 #### Overall Officials **Official 1:** **Affiliation:** University Hospital, Montpellier **Name:** Philippe Courtet, MD PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Unipolar Depression - ID: M16191 - Name: Suicide - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003866 - Term: Depressive Disorder ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00042679 **Brief Title:** A Phase 2 Trial of Antisense Nucleotide to PKC-Alpha (LY900003, ISIS 3521) Plus Gemcitabine and Carboplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer. **Official Title:** A Phase 2 Trial of Antisense Nucleotide to PKC-Alpha (LY900003, ISIS 3521) Plus Gemcitabine and Carboplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer. #### Organization Study ID Info **ID:** 6429 #### Organization **Class:** INDUSTRY **Full Name:** Eli Lilly and Company #### Secondary ID Infos **ID:** H7X-MC-JVAB ### Status Module #### Last Update Post Date **Date:** 2006-07-19 **Type:** ESTIMATED **Last Update Submit Date:** 2006-07-18 **Overall Status:** COMPLETED #### Start Date **Date:** 2002-06 **Status Verified Date:** 2006-07 #### Study First Post Date **Date:** 2002-08-06 **Type:** ESTIMATED **Study First Submit Date:** 2002-08-02 **Study First Submit QC Date:** 2002-08-05 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Eli Lilly and Company ### Description Module **Brief Summary:** The purposes of this study are to determine the following: Whether LY900003 plus gemcitabine and carboplatin can make your tumor smaller or disappear, and for how long. If treatment with LY900003 plus gemcitabine and carboplatin can help you live longer. The safety of LY900003 plus gemcitabine and carboplatin and any side effects that might be associated with the combination of these three drugs. How LY900003 is distributed and broken down by your body when it is given with carboplatin and gemcitabine. Whether LY900003 affects the way gemcitabine and carboplatin are distributed and broken down by your body. **Detailed Description:** Definition: The phase 2 study will provide important information regarding effects of LY900003 on safety and efficacy of patients treated with gemcitabine and carboplatin. LY900003 will be given at approximately 2 mg/kg/day for the first 14 days of a 21-day cycle. The dose and schedule for LY900003 administration are based on results of prior studies of LY900003 and are currently being used in other studies of LY900003. Gemcitabine will be administered on Days 1 and 8 at 1250 mg/m2 and carboplatin will be given on Day 1 at AUC 5. ### Conditions Module **Conditions:** - Carcinoma, Non-Small-Cell Lung - Pulmonary Neoplasms - Neoplasms, Lung **Keywords:** - Non-Small-Cell Lung Cancer - Adenocarcinoma - Carcinoma Squamous - Adult Lung Cancer ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** Gemcitabine **Type:** DRUG #### Intervention 2 **Name:** Carboplatin **Type:** DRUG #### Intervention 3 **Name:** LY900003 **Type:** DRUG ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosis of Non-Small-Cell Lung Cancer. * Stage IV or Stage IIIB disease. * ECOG Performance Status of 0 or 1. * Adequate organ function * One unidimensionally measurable lesion. Exclusion Criteria: * Prior therapy for NSCLC. * Serious concomitant disorders. * Untreated CNS metastases. * Uncontrolled, active infection. * Previous LY900003/ISIS trial participation. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bakersfield **Country:** United States **State:** California **Location 2:** **City:** Berkeley **Country:** United States **State:** California **Location 3:** **City:** Torrance **Country:** United States **State:** California **Location 4:** **City:** Miami Beach **Country:** United States **State:** Florida **Location 5:** **City:** Chicago **Country:** United States **State:** Illinois **Location 6:** **City:** Park Ridge **Country:** United States **State:** Illinois **Location 7:** **City:** Baltimore **Country:** United States **State:** Maryland **Location 8:** **City:** Chattanooga **Country:** United States **State:** Tennessee **Location 9:** **City:** Lubbock **Country:** United States **State:** Texas **Location 10:** **City:** Charlottesville **Country:** United States **State:** Virginia **Location 11:** **City:** Milwaukee **Country:** United States **State:** Wisconsin ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000002283 - Term: Carcinoma, Bronchogenic - ID: D000001984 - Term: Bronchial Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M11172 - Name: Lung Neoplasms - Relevance: HIGH - As Found: Pulmonary Neoplasms - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: HIGH - As Found: Carcinoma, Non-Small-Cell Lung - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M5540 - Name: Carcinoma, Bronchogenic - Relevance: LOW - As Found: Unknown - ID: M5260 - Name: Bronchial Neoplasms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008175 - Term: Lung Neoplasms - ID: D000009369 - Term: Neoplasms - ID: D000002289 - Term: Carcinoma, Non-Small-Cell Lung ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M2985 - Name: Gemcitabine - Relevance: HIGH - As Found: Activity - ID: M18650 - Name: Carboplatin - Relevance: HIGH - As Found: System - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000016190 - Term: Carboplatin - ID: D000093542 - Term: Gemcitabine ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05944679 **Brief Title:** Clinical Utility to Follow-up Radiographs During the First Year of Knee Replacement Surgery **Official Title:** Prospective Randomized Study of the Clinical Utility to Follow-up Radiographs During the First Year of Knee Replacement Surgery #### Organization Study ID Info **ID:** Radioprotesi #### Organization **Class:** OTHER **Full Name:** Corporacion Parc Tauli ### Status Module #### Completion Date **Date:** 2025-01-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-07-13 **Type:** ACTUAL **Last Update Submit Date:** 2023-07-06 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-02-20 **Type:** ESTIMATED #### Start Date **Date:** 2022-01-20 **Type:** ACTUAL **Status Verified Date:** 2023-07 #### Study First Post Date **Date:** 2023-07-13 **Type:** ACTUAL **Study First Submit Date:** 2023-06-27 **Study First Submit QC Date:** 2023-07-06 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Corporacion Parc Tauli #### Responsible Party **Investigator Affiliation:** Corporacion Parc Tauli **Investigator Full Name:** Xavier Pelfort Lopez **Investigator Title:** Doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Primary prosthetic surgery for the treatment of gonarthrosis is currently one of the most prevalent surgical treatments in Traumatology. The Arthroplasty Register in Catalonia, which started in 2005, counted more than 60.000 knee prothesis until 2015. Regarding the peridiocity for taking control radiographs in patients undergoing knee replacement surgery, there is no consensus. This means, that in similar studies that evaluate the results of prosthetic surgery, there is a great variability in radiological follow-up protocols, especifically during the firts post-operative years. Given the high prevalence and the long survival period demonstrated by these implants, it seems reasonable to be able to establish the real value of the radiographs performed during the first year of follow-up after surgery. From this perspective, the aim of our study is to evaluate if conducting just two radiographs instead of five during the first postoperative year after the surgery, has any influence on the clinical and functional results of our patients. ### Conditions Module **Conditions:** - Prosthetic Knee Surgery ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - INVESTIGATOR **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Xray at 1, 3, 6 and 12 months **Intervention Names:** - Radiation: Xray **Label:** Group Xray **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** Xray at 12 months **Intervention Names:** - Radiation: No Xray **Label:** Group No Xray **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group No Xray **Description:** Just one Xray 12 months after the intervention **Name:** No Xray **Type:** RADIATION #### Intervention 2 **Arm Group Labels:** - Group Xray **Description:** Xray at 1, 3, 6 and 12 months after intervention **Name:** Xray **Type:** RADIATION ### Outcomes Module #### Primary Outcomes **Description:** Change value from preoperative condition to 12 months after operation, including 6 month assessment **Measure:** KSS Test change **Time Frame:** Preoperative, 6 and 12 months **Description:** Change value from preoperative condition to 12 months after operation, including 6 month assessment **Measure:** KOOS Test change **Time Frame:** Preoperative, 6 and 12 months **Description:** Change value from preoperative condition to 12 months after operation, including 6 month assessment **Measure:** SF-12 Test change **Time Frame:** Preoperative, 6 and 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients who voluntarily agree to be part of the study and sign the informed consent * Patients awaiting prosthetic knee surgery with a diagnosis of gonarthrosis without age limit (\>18 years) * All cases of prothesis cemented to the tibia and femur will be included, regardless of whether or not the patellar component is prosthetic * Patients with knee prothesis and cruciate ligament retention, with ultracongruent polyethylene or posterostabilized as a maximum degree of prosthetic constriction * The implants will be the usual ones used in our Center for primary prosthetic knee surgery, Journey (smith-Nephew) and Persona or NexGen (Zimmer) Exclusion Criteria: * Patients who do not voluntariily agree to participate * Patients undergoing primary prosthetic surgery in relation to tibial plate fractures * Patients awaiting a unicompartimental or patellofemoral prothesis * Patients who, for any reason, want to leave the study during the follow-up period **Maximum Age:** 100 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Xavier Pelfort **Phone:** +34937231010 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Mireia Viñas **Phone:** +34937231010 **Phone Ext:** 21660 **Role:** CONTACT #### Locations **Location 1:** **City:** Sabadell **Contacts:** ***Contact 1:*** - **Name:** Mireia - **Phone Ext:** 21660 - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Parc taulí **State:** Barcelona **Status:** RECRUITING **Zip:** 08208 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Evans JT, Walker RW, Evans JP, Blom AW, Sayers A, Whitehouse MR. How long does a knee replacement last? A systematic review and meta-analysis of case series and national registry reports with more than 15 years of follow-up. Lancet. 2019 Feb 16;393(10172):655-663. doi: 10.1016/S0140-6736(18)32531-5. Epub 2019 Feb 14. Erratum In: Lancet. 2019 Feb 20;: **PMID:** 30782341 **Citation:** Gomez-Valero S, Garcia-Perez F, Florez-Garcia MT, Miangolarra-Page JC. A systematic review of self-administered questionnaires for the functional assessment of patients with knee disabilities adapted into Spanish. Rev Esp Cir Ortop Traumatol. 2017 Mar-Apr;61(2):96-103. doi: 10.1016/j.recot.2016.11.002. Epub 2017 Jan 31. English, Spanish. **PMID:** 28159566 **Citation:** Walker LC, Clement ND, Bardgett M, Weir D, Holland J, Gerrand C, Deehan DJ. The WOMAC score can be reliably used to classify patient satisfaction after total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2018 Nov;26(11):3333-3341. doi: 10.1007/s00167-018-4879-5. Epub 2018 Feb 26. Erratum In: Knee Surg Sports Traumatol Arthrosc. 2018 Apr 11;: **PMID:** 29484445 **Citation:** Roos EM, Toksvig-Larsen S. Knee injury and Osteoarthritis Outcome Score (KOOS) - validation and comparison to the WOMAC in total knee replacement. Health Qual Life Outcomes. 2003 May 25;1:17. doi: 10.1186/1477-7525-1-17. **PMID:** 12801417 **Citation:** Meneghini RM, Mont MA, Backstein DB, Bourne RB, Dennis DA, Scuderi GR. Development of a Modern Knee Society Radiographic Evaluation System and Methodology for Total Knee Arthroplasty. J Arthroplasty. 2015 Dec;30(12):2311-4. doi: 10.1016/j.arth.2015.05.049. Epub 2015 May 29. **PMID:** 26122112 **Citation:** Rissolio L, Sabatini L, Risitano S, Bistolfi A, Galluzzo U, Masse A, Indelli PF. Is It the Surgeon, the Patient, or the Device? A Comprehensive Clinical and Radiological Evaluation of Factors Influencing Patient Satisfaction in 648 Total Knee Arthroplasties. J Clin Med. 2021 Jun 12;10(12):2599. doi: 10.3390/jcm10122599. **PMID:** 34204628 **Citation:** Sarmah SS, Patel S, Hossain FS, Haddad FS. The radiological assessment of total and unicompartmental knee replacements. J Bone Joint Surg Br. 2012 Oct;94(10):1321-9. doi: 10.1302/0301-620X.94B10.29411. **PMID:** 23015555 **Citation:** Ewald FC. The Knee Society total knee arthroplasty roentgenographic evaluation and scoring system. Clin Orthop Relat Res. 1989 Nov;(248):9-12. **PMID:** 2805502 **Citation:** Khalifa AA, Mullaji AB, Mostafa AM, Farouk OA. A Protocol to Systematic Radiographic Assessment of Primary Total Knee Arthroplasty. Orthop Res Rev. 2021 Jul 17;13:95-106. doi: 10.2147/ORR.S320372. eCollection 2021. **PMID:** 34305412 **Citation:** Baek JH, Lee SC, Choi K, Ahn HS, Nam CH. Long-term survivorship of total knee arthroplasty with a single-radius, high-flexion posterior stabilized prosthesis. Knee. 2021 Jun;30:275-282. doi: 10.1016/j.knee.2021.04.017. Epub 2021 May 11. **PMID:** 33984746 **Citation:** Miralles-Munoz FA, Rubio-Morales M, Bello-Tejada L, Gonzalez-Parreno S, Lizaur-Utrilla A, Alonso-Montero C. Varus alignment of the tibial component up to seven degrees is not associated with poor long-term outcomes in a neutrally aligned total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2022 Aug;30(8):2768-2775. doi: 10.1007/s00167-021-06627-3. Epub 2021 Jun 26. **PMID:** 34175990 **Citation:** Sabatini L, Aprato A, Camazzola D, Bistolfi A, Capella M, Masse A. Primary total knee arthroplasty in tibial plateau fractures: Literature review and our institutional experience. Injury. 2023 Mar;54 Suppl 1:S15-S23. doi: 10.1016/j.injury.2021.02.006. Epub 2021 Feb 7. **PMID:** 33583591 **Citation:** Webb JI, Stoner RS, Afzal I, Evans CR, Scott G, Field RE. The Medial Rotation Knee replacement: Clinical and radiological results of a multi-centre surveillance study at five years. Knee. 2021 Jan;28:247-255. doi: 10.1016/j.knee.2020.12.025. Epub 2021 Jan 13. **PMID:** 33453513 **Citation:** Glaser D, Lotke P. Cost-effectiveness of immediate postoperative radiographs after uncomplicated total knee arthroplasty: a retrospective and prospective study of 750 patients. J Arthroplasty. 2000 Jun;15(4):475-8. doi: 10.1054/arth.2000.4338. **PMID:** 10884208 **Citation:** Hassan S, Wall A, Ayyaswamy B, Rogers S, Mills SP, Charalambous CP. Is there a need for early post-operative x-rays in primary total knee replacements? Experience of a centre in the UK. Ann R Coll Surg Engl. 2012 Apr;94(3):199-200. doi: 10.1308/003588412X13171221501780. Erratum In: Ann R Coll Surg Engl. 2012 May;94(4):231. Ayyawamy, B [corrected to Ayyaswamy, B]. **PMID:** 22507727 **Citation:** Novack TA, Patel JN, Koss J, Mazzei C, Harrington CJ, Wittig JC, Dundon J. Is There a Need for Recovery Room Radiographs Following Uncomplicated Primary Total Knee Arthroplasty? Cureus. 2021 Apr 18;13(4):e14544. doi: 10.7759/cureus.14544. **PMID:** 34017659 **Citation:** Aljawder A, Alomran D, Alayyoub M, Alkhalifa F. Immediate Postoperative Portable Radiograph After Total Knee Replacements: A Necessity or a Burden? Open Orthop J. 2018 May 31;12:173-179. doi: 10.2174/1874325001812010173. eCollection 2018. **PMID:** 29997704 #### See Also Links **Label:** Knee and hip implants used in the National Health System **URL:** https://aquas.gencat.cat/web/.content/minisite/aquas/publicacions/2021/implantes_cadera_rodilla_sns_redets_aquas_2021.pdf ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05063279 **Acronym:** RELIEF **Brief Title:** RELIEF - Resistance Training for Life **Official Title:** Resistance Training for Life - the Efficacy of Increasing Resistance Training Volume for Improving Muscle Mass, Function, Biology and Health in Young and Elderly #### Organization Study ID Info **ID:** TR030 #### Organization **Class:** OTHER **Full Name:** Inland Norway University of Applied Sciences ### Status Module #### Completion Date **Date:** 2022-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2022-08-08 **Type:** ACTUAL **Last Update Submit Date:** 2022-08-05 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2022-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2021-09-06 **Type:** ACTUAL **Status Verified Date:** 2022-08 #### Study First Post Date **Date:** 2021-10-01 **Type:** ACTUAL **Study First Submit Date:** 2021-09-11 **Study First Submit QC Date:** 2021-09-27 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Sykehuset Innlandet HF #### Lead Sponsor **Class:** OTHER **Name:** Stian Ellefsen #### Responsible Party **Investigator Affiliation:** Inland Norway University of Applied Sciences **Investigator Full Name:** Stian Ellefsen **Investigator Title:** Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Sarcopenia is an age-related gradual loss of muscle mass and strength and is associated with physical disability and mortality risk. Currently, the most promising remedy for preventing and treating sarcopenia is physical activity, particularly progressive resistance training. Yet, the amount of resistance exercise needed to achieve optimal benefits remains largely unknown. This lack of knowledge is underpinned by the notion that aging reduces the ability to adapt to (and benefit from) resistance training, and is further complicated by a relative large degrees of between-subject heterogeneity. The primary aim of the study is to compare the effects of 10 weeks of resistance training with low- and moderate volume (one vs. three sets per exercise) on muscle mass accretion in lower and upper body extremities in young (\<30 years of age) and elderly individuals (\>70 years of age). Specifically, the study addresses the hypothesis that elderly individuals will benefit more from higher exercise volume (moderate vs. low) compared to their young counterparts. In addition, the study aims to compare the efficacy of the two volume conditions for altering other characteristics such as muscle strength and biology, including assessment of associations between individual changes in muscle mass, strength and biology (e.g. the relationship between muscle mass accretion and muscle content of rRNA/rDNA), and also to investigate the general health effects of the intervention. ### Conditions Module **Conditions:** - Sarcopenia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** Study conditions (exercise volume) are randomized to either leg/arm for within-participant comparisons. The effect of age is assessed from two parallel age groups. ##### Masking Info **Masking:** DOUBLE **Masking Description:** Study conditions (exercise volume) and age groups identifiers are omitted from outcome assessments whenever possible. Assessment of the primary (and selected secondary) outcome(s) will be performed in a blinded fashion by assessors/investigators. **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants in two age groups will receive moderate (three sets of per exercise per session) and low-volume (one set of resistance per session) training allocated to either right or left upper- and lower extremities. A total of 24 sessions will be performed over 10-12 weeks. **Intervention Names:** - Other: Progressive resistance training **Label:** Resistance training group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** A negative control group is included in the study which will not receive any resistance training. **Label:** Negative control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Resistance training group **Description:** Progressive resistance training, performed with a target number of repetitions of 10 per set. Sets are performed to exhaustion, and external load will be adjusted to meet the target number of repetitions. **Name:** Progressive resistance training **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Musle thickness of m. vastus lateralis measured using ultrasound **Measure:** Muscle thickness, m. vastus lateralis (mid) **Time Frame:** Change from baseline to after 12 sessions **Description:** Muscle strength will be assessed as a weighted average of lower body isokinetic and isometric knee extensor maximal force **Measure:** Muscle strength, lower-body extremities (mid) **Time Frame:** Change from baseline to after 12 sessions **Description:** Muscle strength of the arms measured as isometric force (elbow flexors; fixed angle) **Measure:** Muscle strength, upper-body extremities (mid) **Time Frame:** Change from baseline to after 12 sessions **Description:** Muscular peak power/force measured using dynamic leg press **Measure:** Muscular peak power/force, lower-body extremities **Time Frame:** Change from baseline to after 12 sessions **Description:** Muscle architecture pennation angle of m. vastus lateralis measured using ultrasound **Measure:** Muscle architecture, m. vastus lateralis (mid) **Time Frame:** Change from baseline to after 12 sessions **Description:** Muscle architecture pennation angle of m. vastus lateralis measured using ultrasound **Measure:** Muscle architecture, m. vastus lateralis **Time Frame:** Change from baseline to the training period (10-12 weeks). **Description:** Whole Body Dual X-Ray Absorptiometry to estimate lean mass, bone mineral density and fat mass. **Measure:** Body composition **Time Frame:** Change from baseline to after the training period (10-12 weeks). **Description:** Muscle fiber characteristics such as muscle fiber proportions, cross-sectional area, myonuclei content and capillarization measured in biopsies from m. vastus lateralis **Measure:** Muscle fibre characteristics in m. vastus lateralis **Time Frame:** Change from baseline to after the training period (10-12 weeks) **Description:** Total-RNA abundance measured in biopsies from m. vastus lateralis. **Measure:** Total-RNA abundance in m. vastus lateralis **Time Frame:** Change from baseline to after the training period (10-12 weeks) **Description:** Total-RNA abundance measured in biopsies from m. vastus lateralis. **Measure:** Total-RNA abundance in m. vastus lateralis **Time Frame:** Change from baseline to after 6 training sessions **Description:** rRNA/RNA abundances measured in biopsies from m. vastus lateralis. **Measure:** rRNA/RNA abundances in m. vastus lateralis **Time Frame:** Change from baseline to after the training period (10-12 weeks) **Description:** rRNA/RNA abundances measured in biopsies from m. vastus lateralis. **Measure:** rRNA/mRNA abundances in m. vastus lateralis **Time Frame:** Change from baseline to after 6 training sessions **Description:** Protein abundances measured in biopsies from m. vastus lateralis. **Measure:** Protein abundances in m. vastus lateralis **Time Frame:** Change from baseline to after the training period (10-12 weeks) **Description:** Protein abundances measured in biopsies from m. vastus lateralis. **Measure:** Protein abundance in m. vastus lateralis **Time Frame:** Change from baseline to after 6 training sessions **Description:** Ribosomal DNA content measured in m. vastus lateralis **Measure:** rDNA content in m. vastus lateralis **Time Frame:** Measured at baseline **Description:** Ribosomal DNA content measured in m. vastus lateralis **Measure:** rDNA content in m. vastus lateralis **Time Frame:** Change from baseline to after the training period (10-12 weeks) **Description:** Ribosomal DNA content measured in m. vastus lateralis **Measure:** rDNA content in m. vastus lateralis, (mid) **Time Frame:** Change from baseline to after 12 sessions **Description:** Ribosomal DNA content measured in whole-blood **Measure:** rDNA content, whole-blood **Time Frame:** Measured at baseline **Description:** Ribosomal DNA content measured in whole-blood **Measure:** rDNA content, whole-blood **Time Frame:** Change from baseline to after the training period (10-12 weeks) **Description:** Ribosomal DNA content measured in whole-blood **Measure:** rDNA content, whole-blood (mid) **Time Frame:** Change from baseline to after 12 sessions **Description:** Epigenetic traits measured as DNA methylation/histone modifications in m. vastus lateralis **Measure:** Epigenetic traits, muscle **Time Frame:** Measured at baseline **Description:** Epigenetic traits measured as DNA methylation/histone modifications in m. vastus lateralis **Measure:** Epigenetic traits, muscle **Time Frame:** Change from baseline to after the training period (10-12 weeks) **Description:** Epigenetic traits measured as DNA methylation/histone modifications in m. vastus lateralis **Measure:** Epigenetic traits, muscle **Time Frame:** Change from baseline to after 12 sessions **Description:** Resting blood pressure **Measure:** Blood pressure **Time Frame:** Change from baseline to after the training period (10-12 weeks). **Description:** Total hemoglobin mass measured using the carbon monoxide rebreathing method **Measure:** Hemoglobin mass **Time Frame:** Change from baseline to after the training period (10-12 weeks). **Description:** Blood glucose and endocrine responses to a 2h glucose tolerance test (75 g bolus of glucose). **Measure:** Glucose tolerance **Time Frame:** Change from baseline to after the training period (10-12 weeks). **Description:** Systemic inflammation measured as blood markers such as C-reactive protein (CRP) in resting blood samples. **Measure:** Systemic inflammation **Time Frame:** Change from baseline to after the training period (10-12 weeks). **Description:** Concentrations of various lipoproteins and lipids in blood measured using targeted metabolomics **Measure:** Lipoproteins and lipids in blood **Time Frame:** Change from baseline to after the training period (10-12 weeks) **Description:** Long-term glucose levels measured as hemoglobin glycosylation **Measure:** Hemoglobin glycosylation **Time Frame:** Change from baseline to after the training period (10-12 weeks) **Description:** Concentrations of hormones such as testosterone, growth hormone, thyroid hormones, cortisol and insulin (c-peptide) in serum **Measure:** Hormone concentrations in blood **Time Frame:** Change from baseline to after the training period (10-12 weeks) **Description:** Health-related quality of life measured using the SF-36 questionnaire **Measure:** Health-related quality of life (SF-36) **Time Frame:** Change from baseline to after the training period (10-12 weeks) **Description:** Sarcopenia score assessed using SARC-F (questionnaire) **Measure:** SARC-F **Time Frame:** Measured at baseline **Description:** Sarcopenia score assessed using SARC-F (questionnaire) **Measure:** SARC-F **Time Frame:** Change from baseline to after the training period (10-12 weeks) **Description:** Dietary composition assessed using a food-frequency questionnaire (nutritional composition, energy intake, habitual patterns of dietary intake) **Measure:** Dietary registration **Time Frame:** Measured at baseline **Description:** Dietary composition assessed using a food-frequency questionnaire (nutritional composition, energy intake, habitual patterns of dietary intake) **Measure:** Dietary registration **Time Frame:** Measured after 12 sessions **Description:** Information about intervention-specific training, including training frequency, volume and load **Measure:** Training diary relating to the intervention protocol **Time Frame:** Throughout the intervention (continuous) **Description:** Activities of daily living measured using a questionnaire (i.e. time spent in activity, intensities and type of activity) **Measure:** Activities of daily living (questionnaire) **Time Frame:** Measured at baseline **Description:** Daily activity level registred over three to five days using an accelerometer. **Measure:** Daily activity level **Time Frame:** Measured during the intervention #### Primary Outcomes **Description:** Muscle size of lower extremity knee extensors measured with magnetic resonance imaging (MRI). **Measure:** Muscle size, lower extremities **Time Frame:** Change from baseline to after the training period (10-12 weeks) #### Secondary Outcomes **Description:** Muscle size of upper extremity elbow flexors measured with magnetic resonance imaging (MRI). **Measure:** Muscle size, upper-body extremities **Time Frame:** Change from baseline to after the training period (10-12 weeks) **Description:** Appendicular lean mass of the legs measured using Dual X-Ray Absorptiometry **Measure:** Appendicular lean mass, lower-body extremities **Time Frame:** Change from baseline to after the training period (10-12 weeks) **Description:** Appendicular lean mass of the arms measured using Dual X-Ray Absorptiometry **Measure:** Appendicular lean mass, upper-body extremities **Time Frame:** Change from baseline to after the training period (10-12 weeks) **Description:** Musle thickness of m. vastus lateralis measured using ultrasound **Measure:** Muscle thickness, m. vastus lateralis **Time Frame:** Change from baseline to after the training period (10-12 weeks) **Description:** Muscle strength of the legs measured as a weighted average of lower body isokinetic and isometric knee extensor maximal force **Measure:** Muscle strength, lower-body extremities **Time Frame:** Change from baseline to after the training period (10-12 weeks) **Description:** Muscle strength of the arms measured as isometric force (elbow flexors; fixed angle) **Measure:** Muscle strength, upper-body extremities **Time Frame:** Change from baseline to after the training period (10-12 weeks) **Description:** Muscular peak power/force measured using dynamic leg press **Measure:** Muscular peak power/force, lower-body extremities **Time Frame:** MeasurChange from baseline to after the training period (10-12 weeks) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Ages between 18 and 30 or \> 70 Exclusion Criteria: * Resistance training, \> 1 session per week * Endurance training, \> 3 sessions per week * Unstable cardiovascular disease * Illness or serious injury contradicting resistance training * Serious mental illness * Allergy to local anaesthesia **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Daniel Hammarström, PhD **Phone:** +4740555928 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Stian Ellefsen, PhD **Role:** CONTACT #### Locations **Location 1:** **City:** Lillehammer **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Daniel Hammarström, PhD - **Phone:** +4740555928 - **Role:** CONTACT **Country:** Norway **Facility:** Inland Norway University of Applied Sciences **Status:** RECRUITING **Zip:** 2624 #### Overall Officials **Official 1:** **Affiliation:** Inland Norway University of Applied Sciences **Name:** Stian Ellefsen, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** The full data sets used to analyze study outcomes will be made available with the publication of the study. Data sets will be included or referred to in the publication and hosted online. **Info Types:** - STUDY_PROTOCOL - ANALYTIC_CODE **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009133 - Term: Muscular Atrophy - ID: D000020879 - Term: Neuromuscular Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000001284 - Term: Atrophy - ID: D000020763 - Term: Pathological Conditions, Anatomical ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M28396 - Name: Sarcopenia - Relevance: HIGH - As Found: Sarcopenia - ID: M12090 - Name: Muscular Atrophy - Relevance: LOW - As Found: Unknown - ID: M4589 - Name: Atrophy - Relevance: LOW - As Found: Unknown - ID: M22619 - Name: Neuromuscular Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000055948 - Term: Sarcopenia ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02909179 **Acronym:** mCARE-II **Brief Title:** Measuring the Impact of a Mobile Health System to Support Healthy Pregnancies and Improve Newborn Survival **Official Title:** mCARE II: Enhancing, Integrating and Scaling mCARE and Measuring the Impact of a Mobile Health System to Support Healthy Pregnancies and Improve Newborn Survival #### Organization Study ID Info **ID:** IRB00006469 #### Organization **Class:** OTHER **Full Name:** Johns Hopkins Bloomberg School of Public Health ### Status Module #### Completion Date **Date:** 2020-12-22 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-07-17 **Type:** ACTUAL **Last Update Submit Date:** 2023-07-13 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-12-22 **Type:** ACTUAL #### Start Date **Date:** 2016-06 **Type:** ACTUAL **Status Verified Date:** 2023-07 #### Study First Post Date **Date:** 2016-09-21 **Type:** ESTIMATED **Study First Submit Date:** 2016-09-19 **Study First Submit QC Date:** 2016-09-20 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** mPower Social Enterprises Limited **Class:** UNKNOWN **Name:** The JiVitA Project #### Lead Sponsor **Class:** OTHER **Name:** Johns Hopkins Bloomberg School of Public Health #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this community-based randomized controlled trial is to test whether the mCARE-II intervention package, delivered by the existing Government of Bangladesh community health workforce, will improve neonatal and perinatal survival in a rural setting in northwestern Bangladesh. mCARE-II is a digital health intervention, which incorporates automated workload scheduling, client prioritization and risk stratification, overdue service reminders and demand generation through client side reminder messaging. The intervention package focuses on the pregnancy and early postpartum period. **Detailed Description:** The aim of this study is to implement and evaluate the mCARE-II intervention package using a randomized controlled trial design. This package, supported by an mHealth application, provides workflow scheduling for guided household registration, census, pregnancy surveillance, and antenatal, postnatal, and essential newborn care visit reminders. Workflow scheduling is sorted and prioritized based on assessment of basic risk. Furthermore, the system integrates client-directed reminder SMS messages and demand-side birth notifications to schedule postnatal services immediately after birth. This will be operated by the Government of Bangladesh (GoB) community health workers, called Family Welfare Assistants (FWAs), in 18 unions of one northern district of Bangladesh who will use the system to support their routine health service delivery functions. Based on lessons learned from phase I implementation under the pilot study, additional features will be added to the intervention package, including a priority sorting algorithm to identify pregnant women and newborns with known risk factors for adverse outcomes to prioritize them for scheduled visits, a birth preparedness module to help pregnant women and their families plan for safe delivery and childbirth, and targeted newborn care counseling during late antenatal encounters. These features will be built on a scalable platform compatible with national data systems and aligned with a new global standard being advocated by WHO - the Open Smart Register Platform or OpenSRP (smartregister.org). Based on randomization to mCARE-II or control arms by FWA catchment area, participants living in each area will receive services from their FWA, either supported by OpenSRP or according to the standard of care procedures currently in place. Performance of the FWAs and the health status of enrolled women and newborns will be monitored and evaluated by a rigorous research layer supported by a cadre of research workers who will verify services received by participants to assess exposure to and interactions with FWAs and OpenSRP. This study combines a robust RCT methodology with principles of implementation science - actual government health workers using OpenSRP to support their routine work while a cadre of highly-trained research workers collects 'gold-standard' denominator data against which to measure performance. This study is an effort to rigorously evaluate the set of mCARE-II interventions on the OpenSRP platform. ### Conditions Module **Conditions:** - High Perinatal Mortality - High Neonatal Mortality - Low Antenatal Care Service Utilization - Low Postnatal Care Service Utilization **Keywords:** - Community Health Workers, mHealth, mobile phones, ANC, PNC, essential newborn care ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 113539 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** mCARE-II supported service provision through existing community health workforce. **Intervention Names:** - Other: mCARE-II **Label:** mCARE-II **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Standard of care, paper-based service provision through existing community health workforce. **Label:** Comparison **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - mCARE-II **Description:** mCARE-II is a package of interventions that provides guided client enumeration and follow-up support to community health workers, automated workflow scheduling, risk assessment, client prioritization and stratification and client-based demand generation messaging. These features are incorporated into a platform called OpenSRP, which integrates text message reminders, scheduling, and form submissions on the server side, and displays schedules and client lists on a tablet-based application for community health workers. **Name:** mCARE-II **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Decrease in Neonatal Mortality **Time Frame:** Within 43 days after birth **Measure:** Decrease in perinatal mortality **Time Frame:** 22 Weeks Gestation through the first 7 days after birth #### Secondary Outcomes **Measure:** Increase in postnatal care utilization **Time Frame:** Within 7 days of delivery/child birth **Measure:** Increase in essential newborn care utilization **Time Frame:** Within 7 days of delivery/child birth **Measure:** Increase in antenatal care utilization **Time Frame:** up to 34 weeks of pregnancy **Measure:** Increase in skilled birth attendance **Time Frame:** During child birth **Measure:** Increase in immediate breastfeeding **Time Frame:** Within first hour of life **Measure:** Increase in facility-based delivery **Time Frame:** At time of delivery **Measure:** Increase in skilled birth attendance **Time Frame:** At time of delivery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Married women of reproductive age living with their husbands in the JiVitA study area in Gaibandha, Bangladesh * Consented for participation in 8 weekly pregnancy surveillance * Self reported as being pregnant * Infants born to eligible, enrolled women Exclusion Criteria: * Women who are menopausal or sterilized * Refused to participate in 8 weekly pregnancy surveillance **Healthy Volunteers:** True **Maximum Age:** 45 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Gaibandha **Country:** Bangladesh **Facility:** JiVitA: Maternal and Child & Nutrition Research Site **Zip:** 5700 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Darmstadt GL, Bhutta ZA, Cousens S, Adam T, Walker N, de Bernis L; Lancet Neonatal Survival Steering Team. Evidence-based, cost-effective interventions: how many newborn babies can we save? Lancet. 2005 Mar 12-18;365(9463):977-88. doi: 10.1016/S0140-6736(05)71088-6. **PMID:** 15767001 **Citation:** Schiffman J, Darmstadt GL, Agarwal S, Baqui AH. Community-based intervention packages for improving perinatal health in developing countries: a review of the evidence. Semin Perinatol. 2010 Dec;34(6):462-76. doi: 10.1053/j.semperi.2010.09.008. **PMID:** 21094420 **Citation:** Jones G, Steketee RW, Black RE, Bhutta ZA, Morris SS; Bellagio Child Survival Study Group. How many child deaths can we prevent this year? Lancet. 2003 Jul 5;362(9377):65-71. doi: 10.1016/S0140-6736(03)13811-1. **PMID:** 12853204 **Citation:** Baqui AH, Rosen HE, Lee AC, Applegate JA, El Arifeen S, Rahman SM, Begum N, Shah R, Darmstadt GL, Black RE. Preterm birth and neonatal mortality in a rural Bangladeshi cohort: implications for health programs. J Perinatol. 2013 Dec;33(12):977-81. doi: 10.1038/jp.2013.91. Epub 2013 Aug 15. **PMID:** 23949837 **Citation:** Jo Y, Labrique AB, Lefevre AE, Mehl G, Pfaff T, Walker N, Friberg IK. Using the lives saved tool (LiST) to model mHealth impact on neonatal survival in resource-limited settings. PLoS One. 2014 Jul 11;9(7):e102224. doi: 10.1371/journal.pone.0102224. eCollection 2014. Erratum In: PLoS One. 2014;9(8):e106980. **PMID:** 25014008 **Citation:** G Mehl, L Vasudevan, L Gonsalves, M Berg, T Seimon, M Temmerman, AB Labrique. Harnessing mHealth in low-resource settings to achieve universal access to health. In: Marsch LA, Lord SE, Dallery J, editors. Transforming Behavioral Health Care with Technology: The State of the Science. Oxford University Press; 2014 **Citation:** Labrique AB, Vasudevan L, Kochi E, Fabricant R, Mehl G. mHealth innovations as health system strengthening tools: 12 common applications and a visual framework. Glob Health Sci Pract. 2013 Aug 6;1(2):160-71. doi: 10.9745/GHSP-D-13-00031. eCollection 2013 Aug. **PMID:** 25276529 **Citation:** Lund S, Hemed M, Nielsen BB, Said A, Said K, Makungu MH, Rasch V. Mobile phones as a health communication tool to improve skilled attendance at delivery in Zanzibar: a cluster-randomised controlled trial. BJOG. 2012 Sep;119(10):1256-64. doi: 10.1111/j.1471-0528.2012.03413.x. Epub 2012 Jul 17. **PMID:** 22805598 **Citation:** Tran MC, Labrique AB, Mehra S, Ali H, Shaikh S, Mitra M, Christian P, West K Jr. Analyzing the mobile "digital divide": changing determinants of household phone ownership over time in rural bangladesh. JMIR Mhealth Uhealth. 2015 Feb 25;3(1):e24. doi: 10.2196/mhealth.3663. **PMID:** 25720457 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000003643 - Term: Death - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M30666 - Name: Perinatal Death - Relevance: HIGH - As Found: Perinatal Mortality - ID: M6845 - Name: Death - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000066087 - Term: Perinatal Death ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05371379 **Brief Title:** Multiple Ascending Dose Study of CM338 in Healthy Volunteers **Official Title:** A Multiple-dose, Randomized, Double Blind, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM338 Injection in Healthy Subjects #### Organization Study ID Info **ID:** CM338-100002 #### Organization **Class:** INDUSTRY **Full Name:** Keymed Biosciences Co.Ltd ### Status Module #### Completion Date **Date:** 2022-06-01 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** NOT_YET_RECRUITING #### Last Update Post Date **Date:** 2022-05-12 **Type:** ACTUAL **Last Update Submit Date:** 2022-05-07 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2022-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2022-06-01 **Type:** ESTIMATED **Status Verified Date:** 2022-05 #### Study First Post Date **Date:** 2022-05-12 **Type:** ACTUAL **Study First Submit Date:** 2022-05-07 **Study First Submit QC Date:** 2022-05-07 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Keymed Biosciences Co.Ltd #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study was a multi-center, randomized, double blind, placebo-controlled, single-dose, dose escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM338 with multiple dosing in healthy subjects. **Detailed Description:** The study included screening period, administration and safety follow-up period. Forty-eight healthy volunteers will be enrolled and randomized into 4 groups. ### Conditions Module **Conditions:** - Healthy Subjects ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 48 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Qquaque week **Intervention Names:** - Biological: CM338 Injection **Label:** CM338 75 mg, subcutaneous injection **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Qquaque week **Intervention Names:** - Biological: CM338 Injection **Label:** CM338 150 mg, subcutaneous injection **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Qquaque week **Intervention Names:** - Biological: CM338 Injection **Label:** CM338 300 mg, subcutaneous injection **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Qquaque week **Intervention Names:** - Biological: CM338 Injection **Label:** CM338 300 mg, intravenous infusion **Type:** EXPERIMENTAL #### Arm Group 5 **Description:** placebo **Intervention Names:** - Biological: CM338 Injection **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - CM338 150 mg, subcutaneous injection - CM338 300 mg, intravenous infusion - CM338 300 mg, subcutaneous injection - CM338 75 mg, subcutaneous injection - Placebo **Description:** A humanized monoclonal antibody. **Name:** CM338 Injection **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing. **Measure:** Incidence of Adverse Events (AEs). **Time Frame:** Up to Week 12. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy male volunteers, aged ≥18 and ≤65 years. * Medical history, vital signs, physical examination, 12-lead ECG, X-ray, and abdominal color ultrasound results are normal, or abnormal without clinically significance. * All clinical laboratory examination are normal, or abnormal without clinical significance. Exclusion Criteria: * Take any prescription medicine within 2 weeks before administration, or take any Chinese medicine or non-prescription medicine within 1 week. * Live attenuated vaccine was administered within 30 days prior to administration or planned to vaccinate during the study period. * Major surgery will be planned during the study period, or major surgery was performed within 4 weeks prior to dosing. * Any blood loss greater than 400 mL by voluntary blood donation or in any other manner within 4 weeks prior to administration. **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M4230 - Name: Antibodies, Monoclonal - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05558579 **Brief Title:** Use of Postop Sling After Biceps Tenodesis **Official Title:** Comparison of Postoperative Sling Use in Patient Outcomes After Isolated Biceps Tenodesis #### Organization Study ID Info **ID:** STUDY20220856 #### Organization **Class:** OTHER **Full Name:** University Hospitals Cleveland Medical Center ### Status Module #### Completion Date **Date:** 2024-09-26 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-04-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-04-22 **Overall Status:** WITHDRAWN #### Primary Completion Date **Date:** 2024-09-26 **Type:** ESTIMATED #### Start Date **Date:** 2023-03-23 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2022-09-28 **Type:** ACTUAL **Study First Submit Date:** 2022-09-23 **Study First Submit QC Date:** 2022-09-23 **Why Stopped:** Unable to enroll participants ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospitals Cleveland Medical Center #### Responsible Party **Investigator Affiliation:** University Hospitals Cleveland Medical Center **Investigator Full Name:** Michael Karns, MD. **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to evaluate whether the use of a sling after surgery (biceps tenodesis) is required in recovery and rehabilitation. Biceps tenodesis is one of the most common surgeries for patients who have biceps tendon inflammation and/or instability, rotator cuff tears, and labral tears that do not get better with medications or physical therapy. A biceps tenodesis involves cutting the biceps tendon and reconnecting it to the shoulder with sutures or metal screws. After surgery, most patients are required to wear a shoulder sling and limit certain arm motions to protect the healing tendon. A recent study found using a more flexible rehabilitation protocol for biceps tenodesis did not change outcomes (strength or range-of-motion) and allows patients to return to some regular activities earlier. This data suggests patients may not need to wear a sling after surgery. Therefore, this study aims to evaluate this. This study will have two groups-one that continues to wear the sling, and one that does not. Patients will be randomly assigned to one of these groups. At each follow-up visit after surgery, shoulder strength and range-of-motion will be measured and several surveys about shoulder function will be completed. These surveys will provide information to compare between both groups. If assigned to the group that wears the sling, patients will record how often they are wearing the sling in a paper diary/log. Additionally, at the 6-month follow-up, an ultrasound will be obtained to make sure the tendon is healing properly regardless of which group patients are assigned to. Finally, medical history will be collected to identify protective and risk factors for any differences that might be found. ### Conditions Module **Conditions:** - Biceps Tenodesis **Keywords:** - shoulder rehabilitation - shoulder sling - biceps disorders ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will continue using shoulder sling per standard of care **Label:** Patients Using Sling **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Patients will not use shoulder sling postoperatively. **Intervention Names:** - Other: No sling use **Label:** Patients Without Sling **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients Without Sling **Description:** Patients will not use standard of care sling **Name:** No sling use **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Percent of Complications As Measured by Medical Records **Time Frame:** Up to 2 years **Measure:** Degrees of Range-of-Motion As Measured by Physical Exam **Time Frame:** Up to 30 minutes **Description:** Strength is measured on a 5-point scale with 0 being no discernible muscle contraction and 5 being muscle contraction and maximum resistance **Measure:** Strength as Measured by Physical Exam **Time Frame:** Up to 30 minutes #### Secondary Outcomes **Description:** VAS is a 10-point scale with 0 being no pain and 10 being worst possible pain **Measure:** Pain as Measured by the Visual Analog Scale **Time Frame:** Up to 5 minutes **Description:** ASES is a 17-item survey that has a score from 0-100 **Measure:** Shoulder Function as Measured by the American Shoulder and Elbow Surgeons (ASES) **Time Frame:** Up to 15 minutes **Description:** SST is a 12-item survey that has a score up to 12 points **Measure:** Shoulder Function as Measured by the Simple Shoulder Test (SST) **Time Frame:** Up to 15 minutes **Description:** CMS is scored up to 100 points maximum **Measure:** Shoulder Function as Measured by Constant Murley Score (CMS) **Time Frame:** Up to 15 minutes **Description:** WORC is a 21-item survey scored on a scale from 2,100 to 0 **Measure:** Shoulder Function as Measured by the Western Ontario Rotator Cuff (WORC) Index **Time Frame:** Up to 15 minutes **Description:** SANE is a 1-item survey that has a score from 0-100 **Measure:** Shoulder Function as Measured by the Single Assessment Numeric Evaluation (SANE) **Time Frame:** Up to 5 minutes **Description:** Yes/no survey asking about satisfaction with care **Measure:** Percent of Patients Satisfied as Measured by Patient Survey **Time Frame:** Up to 5 minutes ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients who undergo open or arthroscopic isolated BT for diagnoses including but not limited to biceps tendinitis or tenosynovitis, biceps tendon tears, partial-thickness rotator cuff tears, subacromial bursitis, superior labrum from anterior to posterior (SLAP) tear, biceps instability * Patients with minimum 6-month follow-up Exclusion Criteria: * Patients who undergo any concomitant procedures necessitating ROM restrictions, including but not limited to rotator cuff repair, labral repair, SLAP lesion repair, or shoulder arthroplasty * Patients with history of prior ipsilateral proximal biceps procedures * Patients with history of conditions resulting in severe shoulder strength and ROM limitations (e.g. severe degenerative glenohumeral osteoarthritis, polymyalgia rheumatica, cervical radiculopathy, significant muscle paralysis, etc.) **Maximum Age:** 89 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Cleveland **Country:** United States **Facility:** University Hospitals **State:** Ohio **Zip:** 44106 #### Overall Officials **Official 1:** **Affiliation:** University Hospitals **Name:** Michael Karns, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** University Hospitals **Name:** Kallie Chen, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02402179 **Brief Title:** Metabolic Availability of Tryptophan From White Maize **Official Title:** Application of the Indicator Amino Acid Oxidation Technique for the Determination of Metabolic Availability of Tryptophan From White Maize Protein, in Young Adult Men #### Organization Study ID Info **ID:** 1000048461 #### Organization **Class:** OTHER **Full Name:** The Hospital for Sick Children ### Status Module #### Completion Date **Date:** 2016-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2016-11-15 **Type:** ESTIMATED **Last Update Submit Date:** 2016-11-11 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2016-04 **Type:** ACTUAL #### Start Date **Date:** 2015-03 **Status Verified Date:** 2016-11 #### Study First Post Date **Date:** 2015-03-30 **Type:** ESTIMATED **Study First Submit Date:** 2015-03-19 **Study First Submit QC Date:** 2015-03-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The Hospital for Sick Children #### Responsible Party **Investigator Affiliation:** The Hospital for Sick Children **Investigator Full Name:** Glenda Courtney-Martin **Investigator Title:** Assistant Professor, Faculty of Kinesiology and Physical Education, U of Toronto; Project Investigator, Research Institute The Hospital for Sick Children **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Our objective is to determine the metabolic availability of Tryptophan in white maize using the indicator amino acid oxidation (IAAO) technique in adult men. **Detailed Description:** Our objective is to determine the metabolic availability of Tryptophan in white maize. Seven young, healthy, male adults will receive graded levels (13.2, 26.4, 39.7, 52.9) of tryptophan requirement of 3.78 mg/kg/d as a crystalline amino acid (AA) mixture and a porridge of white cornmeal protein respectively. ### Conditions Module **Conditions:** - Healthy **Keywords:** - protein quality ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 7 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 13.2, 26.4, 39.7, 52.9% of the mean tryptophan requirement of 3.78 mg/kg/d will be given to subjects. **Intervention Names:** - Other: Tryptophan **Label:** Tryptophan Amino Acid **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Tryptophan Amino Acid **Description:** Tryptophan will be supplied at 13.2, 26.4, 39.7, or 52.9% of requirement; sourced from crystalline amino acid and white cornmeal maize. **Name:** Tryptophan **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The quality of corn protein will be assessed by measuring the amount of its tryptophan available for protein synthesis (metabolic availability) using the slope ration method. The oxidation of the indicator amino acid phenylalanine will be measured in response to feeding graded intakes of tryptophan in a reference protein patterned after egg protein, and provided as a crystalline amino acid mixture. The pattern of oxidation of phylalanine in response to tryptophan provided in corn will be compared to the pattern of oxidation obtained from feeding the reference protein. On each study day, subjects will be fed 8 hourly meals and breath samples will be taken to measure the oxidation of phenylalanine. Samples will be collected at baseline after the fourth meal, and half hourly, beginning 2.5 hrs after the 5th meal. Breath samples will be analyzed for 13CO2 enrichment. **Measure:** Metabolic Availability of Tryptophan in Corn **Time Frame:** 9 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy Adult males (20-49years old). * Stable body weight * Not on any medications that could affect protein and amino acid metabolism e.g. steroids. Exclusion Criteria: * Recent weight loss within the last 3 months or on weight reducing diet. * Unwillingness to participate or unable to tolerate the diet. **Healthy Volunteers:** True **Maximum Age:** 49 Years **Minimum Age:** 20 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Toronto **Country:** Canada **Facility:** The Hospital for Sick Children **State:** Ontario #### Overall Officials **Official 1:** **Affiliation:** Senior Scientist **Name:** Paul Pencharz, MD, PhD, **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Rafii M, Elango R, Ball RO, Pencharz PB, Courtney-Martin G. Metabolic Availability of the Limiting Amino Acids Lysine and Tryptophan in Cooked White African Cornmeal Assessed in Healthy Young Men Using the Indicator Amino Acid Oxidation Technique. J Nutr. 2018 Jun 1;148(6):917-924. doi: 10.1093/jn/nxy039. Erratum In: J Nutr. 2018 Oct 1;148(10):1698. **PMID:** 29741697 ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000018687 - Term: Antidepressive Agents, Second-Generation - ID: D000000928 - Term: Antidepressive Agents - ID: D000011619 - Term: Psychotropic Drugs ### Intervention Browse Module - Browse Branches - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M17115 - Name: Tryptophan - Relevance: HIGH - As Found: Freezing - ID: M4247 - Name: Antidepressive Agents - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown - ID: T21 - Name: Tryptophan - Relevance: HIGH - As Found: Freezing ### Intervention Browse Module - Meshes - ID: D000014364 - Term: Tryptophan ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04159779 **Brief Title:** A Study of Clinical Outcomes in Chronic Lymphocytic Leukemia (CLL) Patients Treated With Venetoclax in Greece **Official Title:** Clinical Outcomes of Chronic Lymphocytic Leukemia (CLL) Patients Treated With Venetoclax in Routine Clinical Settings in Greece #### Organization Study ID Info **ID:** P19-568 #### Organization **Class:** INDUSTRY **Full Name:** AbbVie ### Status Module #### Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-11-14 **Type:** ACTUAL **Last Update Submit Date:** 2023-11-10 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2020-01-13 **Type:** ACTUAL **Status Verified Date:** 2023-11 #### Study First Post Date **Date:** 2019-11-12 **Type:** ACTUAL **Study First Submit Date:** 2019-11-08 **Study First Submit QC Date:** 2019-11-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** AbbVie #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is being done to evaluate the clinical outcomes of Chronic Lymphocytic Leukemia (CLL) participants treated with venetoclax as routine standard of care in Greece. The decision to treat with venetoclax is made by the participant's physician prior to being offered enrollment in this study. The objectives of this study include determining overall response rate, assessing safety information, analyzing patient profiles and disease characteristics and participant quality of life. ### Conditions Module **Conditions:** - Chronic Lymphocytic Leukemia **Keywords:** - Chronic Lymphocytic Leukemia Venetoclax Relapsed/Refractory ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 180 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants for whom the treating physician has decided to treat with venetoclax before enrollment in this study. **Label:** Venetoclax Participants ### Outcomes Module #### Primary Outcomes **Description:** Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines and includes partial response (PR), nodular partial response (nPR), complete response with incomplete bone marrow recovery (CRi), and complete response (CR). **Measure:** Overall Response Rate (ORR) **Time Frame:** At Month 12 #### Secondary Outcomes **Description:** Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines. **Measure:** Overall Response Rate (ORR) **Time Frame:** Up to Month 36 **Description:** Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines. **Measure:** Complete Response (CR) **Time Frame:** Up to Month 36 **Description:** Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines. **Measure:** Complete Response with Incomplete Bone Marrow Recovery (CRi) Rate **Time Frame:** Up to Month 36 **Description:** Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines. **Measure:** Nodule Partial Response (nPR) Rate **Time Frame:** Up to Month 36 **Description:** Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL). **Measure:** Partial Response (PR) Rate **Time Frame:** Up to Month 36 **Description:** Disease progression as Assessed by the Investigator using International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines. **Measure:** Percentage of Participants With Disease Progression or Death **Time Frame:** Up to Month 36 **Description:** Defined as the time between the date of first venetoclax intake and the date of the first assessment documenting progression or death (from any cause). **Measure:** Progression Free Survival (PFS) **Time Frame:** Up to Month 36 **Description:** Defined as the time from first venetoclax intake to death from any cause. **Measure:** Overall Survival (OS) **Time Frame:** Up to Month 36 **Description:** Overall treatment duration of venetoclax. **Measure:** Treatment Duration **Time Frame:** Up to Month 36 **Description:** Defined as the period from first venetoclax intake until objective disease progression (until disease progression or death due to progression, whichever occurs first). **Measure:** Time to Progression (TTP) **Time Frame:** Up to Month 36 **Description:** The 5-Level EuroQol Group Questionnaire (EQ-5D-5L) is a standardized instrument used to measure health-related quality of life that can be used in a wide range of health conditions and treatments. **Measure:** Change in Patient Reported Outcomes **Time Frame:** From Baseline (Week 0) Up to Month 36 **Description:** Determined by assessment of peripheral blood or bone marrow after treatment. **Measure:** Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) **Time Frame:** Up to Month 36 **Description:** Dose modifications include interruptions during ramp-up and maintenance phase. **Measure:** Percentage of Participants with Dose Modifications **Time Frame:** Up to Month 36 **Description:** ADR is defined as a response to a medicinal product that is noxious and unintended and that a causal relationship between a medicinal product and an adverse event is possible, probable or very likely as assessed by the investigator. **Measure:** Percentage of Participants with Adverse Drug Reactions (ADR) **Time Frame:** Up to Month 36 **Description:** Number of lines of prior therapy per participant, in participants with Relapse/Refractory Chronic Lymphocytic Leukemia. **Measure:** Number of Lines of Prior Therapy in Participants with Relapse/Refractory Chronic Lymphocytic Leukemia **Time Frame:** Up to Month 36 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria * Eligible to receive venetoclax as per local label * Physician has decided to initiate CLL treatment with venetoclax and the decision to treat is made by the physician in accordance with the local label prior to any decision to approach the participant about the study * Participant has been fully informed verbally and in writing about the study and does not object to their data being processed or subjected to data quality control Exclusion Criteria: * Prescribed or treated with venetoclax outside of marketing authorization * Currently participating in, or previously participated within 30 days prior to venetoclax start, in any other interventional clinical trial **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** This study will enroll adult participants (age \>=18) with confirmed diagnosis of Relapse/Refractory Chronic Lymphocytic Leukemia being treated with venetoclax in Greece as part of routine standard of care. ### Contacts Locations Module #### Locations **Location 1:** **City:** Athens **Country:** Greece **Facility:** Henry Dunnant Hospital Center /ID# 241682 **State:** Attiki **Zip:** 11526 **Location 2:** **City:** Athens **Country:** Greece **Facility:** General Hospital of Athens Gennimatas /ID# 212917 **State:** Attiki **Zip:** 11527 **Location 3:** **City:** Athens **Country:** Greece **Facility:** General Hospital of Athens Laiko /ID# 212902 **State:** Attiki **Zip:** 11527 **Location 4:** **City:** Athens **Country:** Greece **Facility:** General Hospital of Athens Laiko /ID# 230222 **State:** Attiki **Zip:** 11527 **Location 5:** **City:** Athens **Country:** Greece **Facility:** University General Hospital Attikon /ID# 212915 **State:** Attiki **Zip:** 12462 **Location 6:** **City:** Cholargos **Country:** Greece **Facility:** Metropolitan General /ID# 212934 **State:** Attiki **Zip:** 15562 **Location 7:** **City:** Marousi **Country:** Greece **Facility:** Iatriko Kentro Athinon /ID# 241689 **State:** Attiki **Zip:** 15125 **Location 8:** **City:** Marousi **Country:** Greece **Facility:** Iatriko Kentro Athinon /ID# 241690 **State:** Attiki **Zip:** 15125 **Location 9:** **City:** Piraeus **Country:** Greece **Facility:** Metropolitan Hospital /ID# 241687 **State:** Attiki **Zip:** 18547 **Location 10:** **City:** Heraklion **Country:** Greece **Facility:** University General Hospital of Heraklion PA.G.N.I /ID# 212916 **State:** Kriti **Zip:** 71500 **Location 11:** **City:** Stavroupoli (Thessalonikis) **Country:** Greece **Facility:** Papageorgiou General Hospital Thessaloniki /ID# 213710 **State:** Thessaloniki **Zip:** 55536 **Location 12:** **City:** Alexandroupolis **Country:** Greece **Facility:** General University Hospital of Alexandroupolis /ID# 212927 **Zip:** 68100 **Location 13:** **City:** Athens **Country:** Greece **Facility:** General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 212929 **Zip:** 10676 **Location 14:** **City:** Chania **Country:** Greece **Facility:** General Hospital of Chania "Agios Georgios" /ID# 241685 **Zip:** 73300 **Location 15:** **City:** Ioannina **Country:** Greece **Facility:** University General Hospital of Ioannina /ID# 212936 **Zip:** 45500 **Location 16:** **City:** Larisa **Country:** Greece **Facility:** Reg Gen Univ Hosp Larissa /ID# 213708 **Zip:** 41110 **Location 17:** **City:** Patras **Country:** Greece **Facility:** General Hospital of Patras Agios Andreas /ID# 213711 **Zip:** 26335 **Location 18:** **City:** Patras **Country:** Greece **Facility:** University Gen Hosp of Patra /ID# 212914 **Zip:** 26504 **Location 19:** **City:** Piraeus **Country:** Greece **Facility:** METAXA Cancer Hospital of Piraeus /ID# 212918 **Zip:** 18737 **Location 20:** **City:** Thessaloniki **Country:** Greece **Facility:** Theageneio Anticancer Hospital /ID# 212933 **Zip:** 54639 **Location 21:** **City:** Thessaloniki **Country:** Greece **Facility:** General Hospital of Thessaloniki George Papanikolaou /ID# 213709 **Zip:** 57010 #### Overall Officials **Official 1:** **Affiliation:** AbbVie **Name:** ABBVIE INC. **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### See Also Links **Label:** Related Info **URL:** https://www.rxabbvie.com/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000006402 - Term: Hematologic Diseases - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000008206 - Term: Lymphatic Diseases - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases - ID: D000015448 - Term: Leukemia, B-Cell - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10945 - Name: Leukemia - Relevance: HIGH - As Found: Leukemia - ID: M10951 - Name: Leukemia, Lymphoid - Relevance: HIGH - As Found: Lymphocytic Leukemia - ID: M18116 - Name: Leukemia, Lymphocytic, Chronic, B-Cell - Relevance: HIGH - As Found: Chronic Lymphocytic Leukemia - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M18115 - Name: Leukemia, B-Cell - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1308 - Name: Chronic Lymphocytic Leukemia - Relevance: HIGH - As Found: Chronic Lymphocytic Leukemia - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: HIGH - As Found: Chronic ### Condition Browse Module - Meshes - ID: D000007938 - Term: Leukemia - ID: D000007945 - Term: Leukemia, Lymphoid - ID: D000015451 - Term: Leukemia, Lymphocytic, Chronic, B-Cell ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M249656 - Name: Venetoclax - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04692779 **Brief Title:** A Prospective Clinical Study to Explore Response to Prone Positioning in ARDS Patients **Official Title:** A Prospective Clinical Study to Explore the Mechanism of Patients' Response to Prone Positioning in ARDS Patients, Including COVID-19 #### Organization Study ID Info **ID:** ProneARDS #### Organization **Class:** OTHER **Full Name:** Rush University Medical Center ### Status Module #### Completion Date **Date:** 2022-01-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-08-18 **Type:** ACTUAL **Last Update Submit Date:** 2022-08-16 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-01-31 **Type:** ACTUAL #### Start Date **Date:** 2021-01-31 **Type:** ACTUAL **Status Verified Date:** 2022-08 #### Study First Post Date **Date:** 2021-01-05 **Type:** ACTUAL **Study First Submit Date:** 2020-12-29 **Study First Submit QC Date:** 2020-12-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Rush University Medical Center #### Responsible Party **Investigator Affiliation:** Rush University Medical Center **Investigator Full Name:** Tyler Weiss **Investigator Title:** Clinical Education Coordinator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The proposed study will be conducted to investigate the mechanism of patients' responses to prone positioning with coronavirus disease 2019 (COVID-19) acute respiratory distress syndrome (ARDS) and non-COVID-19 ARDS utilizing lung ultrasound. **Detailed Description:** This is a prospective observational study of adult patients with coronavirus disease 2019 (COVID-19) acute respiratory distress syndrome (ARDS) and non-COVID-19 ARDS who are intubated, in the prone position and receiving mechanical ventilation in the intensive care units at Rush University Medical Center. In this study design, we will prospectively enroll subjects, who fulfill eligibility criteria, to investigate the mechanism of their responses to the first three prone positioning sessions, utilizing lung ultrasound (LUS). Inclusion criteria include: adult subjects 18 years and older with a diagnosis of ARDS, endotracheally intubated and receiving assisted mechanical ventilation, meet criteria for prone positioning (ratio of arterial oxygen tension to the fraction of inspired oxygen (PaO2/FiO2) of ≤ 150 mm Hg with ventilator parameters of positive end-expiratory pressure (PEEP) ≥ 10 cm H2O and FiO2 of .60, and order for prone positioning. Patients will be excluded from the study if they meet the following criteria: pregnant, tracheostomy, receiving extracorporeal membrane oxygenation (ECMO), palliative care, received prone positioning more than once during intubation in an outside hospital, or receive invasive ventilation in an outside hospital for more than 72 hours. Enrolled subjects will undergo LUS 1 hour before and 1 hour after prone positioning by a trained clinician and will be assessed using a LUS score based on LUS pattern. LUS will then be performed again 1 hour before supination (16 hours) and assessed by a LUS score. This process will be repeated on the first 3 prone sessions. Patients will be enrolled in the study for 4 weeks in order to observe patient outcomes. ### Conditions Module **Conditions:** - Covid19 - ARDS **Keywords:** - Prone positioning - Lung ultrasound ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 60 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All intubated ARDS patients undergoing prone positioning will be assessed with LUS before and after prone positioning and before and after placing back in the supine position. **Intervention Names:** - Other: Lung Ultrasound (LUS) **Label:** Intubated ARDS patients undergoing prone positioning ### Interventions #### Intervention 1 **Arm Group Labels:** - Intubated ARDS patients undergoing prone positioning **Description:** Enrolled subjects will undergo LUS 1 hour before and 1 hour after prone positioning by a trained clinician and will be assessed using a LUS score based on LUS pattern. LUS will then be performed again 1 hour before supination (16 hours) and assessed by a LUS score. This process will be repeated on the first 3 prone sessions. Patients will be enrolled in the study for 4 weeks in order to observe patient outcomes. **Name:** Lung Ultrasound (LUS) **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Patients' responses of oxygenation and lung ultrasound score (0 - 36 where 0 = normal lung aeration and 36 = most severe lung consolidation) to prone positioning in the first three prone positioning sessions for ARDS patients. **Measure:** Oxygenation and Lung Ultrasound Score (LUS) **Time Frame:** 10 months #### Secondary Outcomes **Description:** observed lung ultrasound score (0 - 36 where 0 = normal lung aeration and 36 = most severe lung consolidation) differences between patients who respond to prone positioning and those who do not respond among patients with COVID-19 ARDS and non-COVID-19 ARDS. **Measure:** COVID-19 ARDS vs non-COVID-19 ARDS **Time Frame:** 10 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Adult subjects 18 years and older, diagnosis of ARDS 2. endotracheally intubated and receiving assisted mechanical ventilation 3. meet criteria for prone positioning: PaO2/FIO2 (P/F ratio) of ≤ 150 mm Hg with ventilator parameters of PEEP ≥ 10 cm H2O and FiO2 of .60 4. receive an order for prone positioning. Exclusion Criteria: 1. Pregnant 2. Tracheostomy 3. Receiving ECMO 4. Palliative care 5. Receive prone positioning more than once during intubation in an outside hospital 6. Receive invasive ventilation in an outside hospital for more than 72 hours **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Intubated adults (18 years or older) with a diagnosis of ARDS receiving mechanical ventilation and meet criteria for prone positioning. ### Contacts Locations Module #### Locations **Location 1:** **City:** Chicago **Country:** United States **Facility:** Rush University Medical Center **State:** Illinois **Zip:** 60612 #### Overall Officials **Official 1:** **Affiliation:** Rush University Medical Center **Name:** Tyler Weiss, MS **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Rush University Medical Center **Name:** Jie Li, PhD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Arbelot C, Ferrari F, Bouhemad B, Rouby JJ. Lung ultrasound in acute respiratory distress syndrome and acute lung injury. Curr Opin Crit Care. 2008 Feb;14(1):70-4. doi: 10.1097/MCC.0b013e3282f43d05. **PMID:** 18195629 **Citation:** Bouhemad B, Brisson H, Le-Guen M, Arbelot C, Lu Q, Rouby JJ. Bedside ultrasound assessment of positive end-expiratory pressure-induced lung recruitment. Am J Respir Crit Care Med. 2011 Feb 1;183(3):341-7. doi: 10.1164/rccm.201003-0369OC. Epub 2010 Sep 17. **PMID:** 20851923 **Citation:** Bouhemad B, Zhang M, Lu Q, Rouby JJ. Clinical review: Bedside lung ultrasound in critical care practice. Crit Care. 2007;11(1):205. doi: 10.1186/cc5668. **PMID:** 17316468 **Citation:** Doerschug KC, Schmidt GA. Intensive care ultrasound: III. Lung and pleural ultrasound for the intensivist. Ann Am Thorac Soc. 2013 Dec;10(6):708-12. doi: 10.1513/AnnalsATS.201308-288OT. No abstract available. **PMID:** 24364779 **Citation:** Haddam M, Zieleskiewicz L, Perbet S, Baldovini A, Guervilly C, Arbelot C, Noel A, Vigne C, Hammad E, Antonini F, Lehingue S, Peytel E, Lu Q, Bouhemad B, Golmard JL, Langeron O, Martin C, Muller L, Rouby JJ, Constantin JM, Papazian L, Leone M; CAR'Echo Collaborative Network; AzuRea Collaborative Network. Lung ultrasonography for assessment of oxygenation response to prone position ventilation in ARDS. Intensive Care Med. 2016 Oct;42(10):1546-1556. doi: 10.1007/s00134-016-4411-7. Epub 2016 Jun 20. **PMID:** 27324241 **Citation:** Prat G, Guinard S, Bizien N, Nowak E, Tonnelier JM, Alavi Z, Renault A, Boles JM, L'Her E. Can lung ultrasonography predict prone positioning response in acute respiratory distress syndrome patients? J Crit Care. 2016 Apr;32:36-41. doi: 10.1016/j.jcrc.2015.12.015. Epub 2015 Dec 30. **PMID:** 26806842 **Citation:** Wang XT, Ding X, Zhang HM, Chen H, Su LX, Liu DW; Chinese Critical Ultrasound Study Group (CCUSG). Lung ultrasound can be used to predict the potential of prone positioning and assess prognosis in patients with acute respiratory distress syndrome. Crit Care. 2016 Nov 30;20(1):385. doi: 10.1186/s13054-016-1558-0. **PMID:** 27899151 **Citation:** Arentz M, Yim E, Klaff L, Lokhandwala S, Riedo FX, Chong M, Lee M. Characteristics and Outcomes of 21 Critically Ill Patients With COVID-19 in Washington State. JAMA. 2020 Apr 28;323(16):1612-1614. doi: 10.1001/jama.2020.4326. **PMID:** 32191259 **Citation:** Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30. **PMID:** 32007143 **Citation:** Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum In: Lancet. 2020 Jan 30;: **PMID:** 31986264 **Citation:** Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum In: JAMA. 2021 Mar 16;325(11):1113. **PMID:** 32031570 **Citation:** Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994. Erratum In: JAMA Intern Med. 2020 Jul 1;180(7):1031. **PMID:** 32167524 **Citation:** Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24. Erratum In: Lancet Respir Med. 2020 Apr;8(4):e26. **PMID:** 32105632 **Citation:** Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20. **PMID:** 23688302 **Citation:** Munshi L, Del Sorbo L, Adhikari NKJ, Hodgson CL, Wunsch H, Meade MO, Uleryk E, Mancebo J, Pesenti A, Ranieri VM, Fan E. Prone Position for Acute Respiratory Distress Syndrome. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2017 Oct;14(Supplement_4):S280-S288. doi: 10.1513/AnnalsATS.201704-343OT. **PMID:** 29068269 **Citation:** Marini JJ, Hurford WE. Should Early Prone Positioning Be a Standard of Care in ARDS With Refractory Hypoxemia? Wrong Question-Reply. Respir Care. 2016 Nov;61(11):1564-1565. doi: 10.4187/respcare.05288. No abstract available. **PMID:** 27794087 **Citation:** Scholten EL, Beitler JR, Prisk GK, Malhotra A. Treatment of ARDS With Prone Positioning. Chest. 2017 Jan;151(1):215-224. doi: 10.1016/j.chest.2016.06.032. Epub 2016 Jul 8. **PMID:** 27400909 **Citation:** Kallet RH. A Comprehensive Review of Prone Position in ARDS. Respir Care. 2015 Nov;60(11):1660-87. doi: 10.4187/respcare.04271. **PMID:** 26493592 **Citation:** Reilly JP, Calfee CS, Christie JD. Acute Respiratory Distress Syndrome Phenotypes. Semin Respir Crit Care Med. 2019 Feb;40(1):19-30. doi: 10.1055/s-0039-1684049. Epub 2019 May 6. **PMID:** 31060085 **Citation:** Gattinoni L, Chiumello D, Caironi P, Busana M, Romitti F, Brazzi L, Camporota L. COVID-19 pneumonia: different respiratory treatments for different phenotypes? Intensive Care Med. 2020 Jun;46(6):1099-1102. doi: 10.1007/s00134-020-06033-2. Epub 2020 Apr 14. No abstract available. **PMID:** 32291463 **Citation:** Robba C, Battaglini D, Ball L, Patroniti N, Loconte M, Brunetti I, Vena A, Giacobbe DR, Bassetti M, Rocco PRM, Pelosi P. Distinct phenotypes require distinct respiratory management strategies in severe COVID-19. Respir Physiol Neurobiol. 2020 Aug;279:103455. doi: 10.1016/j.resp.2020.103455. Epub 2020 May 11. **PMID:** 32437877 **Citation:** Weiss TT, Cerda F, Scott JB, Kaur R, Sungurlu S, Mirza SH, Alolaiwat AA, Kaur R, Augustynovich AE, Li J. Prone positioning for patients intubated for severe acute respiratory distress syndrome (ARDS) secondary to COVID-19: a retrospective observational cohort study. Br J Anaesth. 2021 Jan;126(1):48-55. doi: 10.1016/j.bja.2020.09.042. Epub 2020 Oct 10. **PMID:** 33158500 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011024 - Term: Pneumonia, Viral - ID: D000011014 - Term: Pneumonia - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000014777 - Term: Virus Diseases - ID: D000018352 - Term: Coronavirus Infections - ID: D000003333 - Term: Coronaviridae Infections - ID: D000030341 - Term: Nidovirales Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M2561 - Name: COVID-19 - Relevance: HIGH - As Found: COVID-19 - ID: M13904 - Name: Pneumonia - Relevance: LOW - As Found: Unknown - ID: M13914 - Name: Pneumonia, Viral - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M20490 - Name: Coronavirus Infections - Relevance: LOW - As Found: Unknown - ID: M6555 - Name: Coronaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M23685 - Name: Nidovirales Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000086382 - Term: COVID-19 ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04363879 **Brief Title:** Comparing Two Types of Endometrial Activation Prior to Embryo Transfer **Official Title:** Comparing Two Types of Endometrial Activation Prior to Embryo Transfer: A Pilot Study #### Organization Study ID Info **ID:** 07-14-06B #### Organization **Class:** OTHER **Full Name:** Wake Forest University Health Sciences ### Status Module #### Completion Date **Date:** 2017-07-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-10-20 **Type:** ACTUAL **Last Update Submit Date:** 2022-10-12 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-07-01 **Type:** ACTUAL #### Results First Post Date **Date:** 2020-05-27 **Type:** ACTUAL **Results First Submit Date:** 2020-04-30 **Results First Submit QC Date:** 2020-05-14 #### Start Date **Date:** 2014-06-16 **Type:** ACTUAL **Status Verified Date:** 2022-09 #### Study First Post Date **Date:** 2020-04-27 **Type:** ACTUAL **Study First Submit Date:** 2020-04-22 **Study First Submit QC Date:** 2020-04-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Wake Forest University Health Sciences #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** To determine if two types of endometrial activation (Pipelle curette or Shepard catheter) prior to embryo transfer result in similar live birth rates. Also to determine if patients experience similar pain from both types of endometrial activation. **Detailed Description:** Assisted reproductive technologies (ART), including in vitro fertilization (IVF), are methods used to treat infertility, which affects approximately 10% reproductive aged women. Physicians at the Women's Institute perform over 300 embryo transfer procedures every year. Despite advances and improvements in ART over the past three decades, clinical pregnancy rate and live birth rate remain 30-40% and 20-30%. Implantation is essential for successful ART and IVF procedures, and many interventions have been studied to possibly improve implantation rates and thus pregnancy and live birth rates. Endometrial activation is one such intervention, sometimes referred to as endometrial "activation" or "scratch," and it is defined as "intentional endometrial injury, such as endometrial biopsy or curettage, in women undergoing ART". A previous study found that implantation rates, clinical pregnancy rates, and live birth rates were more than twofold higher in women who underwent endometrial biopsy in the cycle before subsequent IVF treatment. Another study which examines endometrial activation prior to IVF similarly has concluded that endometrial activation prior to the embryo transfer cycle significantly improves clinical pregnancy rates and live birth rates in women undergoing ART. Although the type of endometrial procedure is not specified, the timing activation was found be most effective when performed in the cycle prior to the embryo transfer. The mechanism of increase endometrial receptivity is still unknown; however three proposed hypothesis exist. The first hypothesis proposes that local activation of the endometrium induces endometrial decidualization which increases the probability of embryo implantation. The second hypothesis is that endometrial healing following endometrial activation increases secreted cytokines, interleukins, growth factors, macrophages, and dendritic cells which are beneficial to embryo implantation. The final hypothesis suggests that endometrial maturation is abnormally advanced during ovarian stimulation, so endometrial activation may lead to better synchronicity between the endometrium and the embryo.. Endometrial activation has been found to have clear benefit in pregnancy and live birth rates in a previous study, however no uniform technique has been determined. The objective of this study is to compare two types of endometrial disruption - a vigorous endometrial biopsy with a Pipelle curette and a four quadrant endometrial "scratch" using a Shepard insemination catheter - to determine if the live birth rates are equivalent for the two methods. The investigators also will compare pain with the two types of endometrial activation. By comparing two distinct types of endometrial activation, the goal is to determine which method is both effective and tolerable to patients. The Shepherd catheter is a 1.8 mm malleable insemination catheter that can be curved to traverse the cervix. It is also used by some physicians in the Women's Institute to perform saline infusion sonography. When the catheter is inserted under ultrasound guidance, it is often placed in the subendometrial tissue, and causes deflection and disruption of the endometrium but is tolerated well. The Pipelle is a 3.1 mm semi-rigid catheter with an internal stylet plunger. A biopsy is performed by placing the catheter into the uterus, withdrawing the stylet to create suction, and aspirating endometrial tissue into the catheter. A study done by Leclair et al. found that the mean pain that women had when the Pipelle was used for an endometrial biopsy was 6.2±2.4 on a visual analog scale from 1-10 (5). Pain with the Shepard catheter has not been studied when it is used for endometrial biopsy. ### Conditions Module **Conditions:** - Infertility - Endometrial Disorder **Keywords:** - Endometrial scratch ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Parallel treatment arms for two types of endometrial scratch ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 195 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion. **Intervention Names:** - Procedure: Endometrial scratch with Pipelle curette **Label:** Endometrial scratch with Pipelle curette **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00. **Intervention Names:** - Procedure: Endometrial scratch with Shepard catheter **Label:** Endometrial scratch with Shepard catheter **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Endometrial scratch with Pipelle curette **Description:** For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion. **Name:** Endometrial scratch with Pipelle curette **Other Names:** - Endometrial activation, endometrial injury **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Endometrial scratch with Shepard catheter **Description:** For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00. **Name:** Endometrial scratch with Shepard catheter **Other Names:** - Endometrial activation, endometrial injury **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Number (count) of births per number of subjects undergoing embryo transfer **Measure:** Number of Participants With Live Births Per Transfers Performed **Time Frame:** Collected up to 1 year after the last embryo transfer #### Secondary Outcomes **Description:** Pain assessed by Visual analog scale (Numeric rating scale, units from 1-10 with 1 being no pain and 10 being maximum pain) **Measure:** Pain Quantifcation After Endometrial Scratch **Time Frame:** Immediately following endometrial scratch **Measure:** Number (Count) of Positive Pregnancy Tests Per Number of Subjects Undergoing Embryo Transfer **Time Frame:** Collected up to 1 year after the last embryo transfer **Measure:** Number (Count) of Pregnancies Per Number of Patients Undergoing Embryo Transfer **Time Frame:** Collected up to 1 year after the last embryo transfer ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All patients undergoing embryo transfer who are in the cycle prior to their embryo transfer Exclusion Criteria: * Patients not undergoing embryo transfer * Known pregnancy * Active pelvic infection * Known endometrial hyperplasia or cancer * Inability to tolerate endometrial catheter placement * Severe cervical stenosis * Patients who will receive operative hysteroscopy in the cycle prior to embryo transfer **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Wake Forest University Health Sciences **Name:** Brad Hurst, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Wake Forest University Health Sciences **Name:** Kathryn Goldrick, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** We do not plan to share individual patient data with other researchers. **IPD Sharing:** NO ### References Module #### References **Citation:** Nastri CO, Ferriani RA, Raine-Fenning N, Martins WP. Endometrial scratching performed in the non-transfer cycle and outcome of assisted reproduction: a randomized controlled trial. Ultrasound Obstet Gynecol. 2013 Oct;42(4):375-82. doi: 10.1002/uog.12539. Epub 2013 Sep 2. **PMID:** 23754314 **Citation:** Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5. **PMID:** 12798877 **Citation:** Nastri CO, Lensen SF, Gibreel A, Raine-Fenning N, Ferriani RA, Bhattacharya S, Martins WP. Endometrial injury in women undergoing assisted reproductive techniques. Cochrane Database Syst Rev. 2015 Mar 22;(3):CD009517. doi: 10.1002/14651858.CD009517.pub3. **PMID:** 25803542 **Citation:** Leclair CM, Zia JK, Doom CM, Morgan TK, Edelman AB. Pain experienced using two different methods of endometrial biopsy: a randomized controlled trial. Obstet Gynecol. 2011 Mar;117(3):636-641. doi: 10.1097/AOG.0b013e31820ad45b. **PMID:** 21343767 **Citation:** Nastri CO, Gibreel A, Raine-Fenning N, Maheshwari A, Ferriani RA, Bhattacharya S, Martins WP. Endometrial injury in women undergoing assisted reproductive techniques. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD009517. doi: 10.1002/14651858.CD009517.pub2. **PMID:** 22786529 ## Document Section ### Large Document Module #### Large Docs - Date: 2020-04-27 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 106448 - Type Abbrev: Prot_SAP - Upload Date: 2020-04-27T12:14 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10290 - Name: Infertility - Relevance: HIGH - As Found: Infertility - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007246 - Term: Infertility ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module **Description:** There were no adverse events #### Event Groups **Group ID:** EG000 **Title:** Endometrial Scratch With Pipelle Curette **Deaths Num At Risk:** 78 **Description:** For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion. Endometrial scratch with Pipelle curette: For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion. **ID:** EG000 **Other Num at Risk:** 78 **Serious Number At Risk:** 78 **Title:** Endometrial Scratch With Pipelle Curette **Group ID:** EG001 **Title:** Endometrial Scratch With Shepard Catheter **Deaths Num At Risk:** 92 **Description:** For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00. Endometrial scratch with Shepard catheter: For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00. **ID:** EG001 **Other Num at Risk:** 92 **Serious Number At Risk:** 92 **Title:** Endometrial Scratch With Shepard Catheter **Frequency Threshold:** 0 **Time Frame:** From start of study until 1 year after last embryo transfer ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 78 **Group ID:** BG001 **Value:** 92 **Group ID:** BG002 **Value:** 170 **Units:** Participants ### Group **ID:** BG000 **Title:** Endometrial Scratch With Pipelle Curette **Description:** For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion. Endometrial scratch with Pipelle curette: For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion. ### Group **ID:** BG001 **Title:** Endometrial Scratch With Shepard Catheter **Description:** For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00. Endometrial scratch with Shepard catheter: For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00. ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 4.6 **Value:** 33.8 #### Measurement **Group ID:** BG001 **Spread:** 3.9 **Value:** 34.2 #### Measurement **Group ID:** BG002 **Spread:** 4.2 **Value:** 34.0 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 78 **Group ID:** BG001 **Value:** 92 **Group ID:** BG002 **Value:** 170 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 78 #### Measurement **Group ID:** BG001 **Value:** 92 #### Measurement **Group ID:** BG002 **Value:** 170 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Male #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 78 **Group ID:** BG001 **Value:** 92 **Group ID:** BG002 **Value:** 170 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 16 #### Measurement **Group ID:** BG001 **Value:** 75 #### Measurement **Group ID:** BG002 **Value:** 91 **Category Title:** Not Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 62 #### Measurement **Group ID:** BG001 **Value:** 17 #### Measurement **Group ID:** BG002 **Value:** 79 **Category Title:** Unknown or Not Reported #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 78 **Group ID:** BG001 **Value:** 92 **Group ID:** BG002 **Value:** 170 **Class Title:** ### Measure #### Measurement **Group ID:** BG002 **Value:** 0 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 0 **Group ID:** BG001 **Value:** 0 **Group ID:** BG002 **Value:** 0 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 78 #### Measurement **Group ID:** BG001 **Value:** 92 #### Measurement **Group ID:** BG002 **Value:** 170 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 78 **Group ID:** BG001 **Value:** 92 **Group ID:** BG002 **Value:** 170 **Class Title:** United States **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** Years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Ethnicity (NIH/OMB) **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** Race and Ethnicity were not collected from any participant. **Title:** Race and Ethnicity Not Collected **Unit of Measure:** Participants ### Measure 5 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** [email protected] **Organization:** AtriumHealth **Phone:** 7043553153 **Title:** Dr. Brad Hurst, Director of Assisted Reproduction Program ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 37 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 43 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.2 - **Upper Limit:** - **Value:** 3.9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.4 - **Upper Limit:** - **Value:** 3.0 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 56 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 62 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 44 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 55 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Number (count) of births per number of subjects undergoing embryo transfer **Parameter Type:** COUNT_OF_PARTICIPANTS **Reporting Status:** POSTED **Time Frame:** Collected up to 1 year after the last embryo transfer **Title:** Number of Participants With Live Births Per Transfers Performed **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion. Endometrial scratch with Pipelle curette: For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion. **ID:** OG000 **Title:** Endometrial Scratch With Pipelle Curette ##### Group **Description:** For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00. Endometrial scratch with Shepard catheter: For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00. **ID:** OG001 **Title:** Endometrial Scratch With Shepard Catheter #### Outcome Measure 2 **Description:** Pain assessed by Visual analog scale (Numeric rating scale, units from 1-10 with 1 being no pain and 10 being maximum pain) **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Immediately following endometrial scratch **Title:** Pain Quantifcation After Endometrial Scratch **Type:** SECONDARY **Unit of Measure:** score on a scale ##### Group **Description:** For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion. Endometrial scratch with Pipelle curette: For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion. **ID:** OG000 **Title:** Endometrial Scratch With Pipelle Curette ##### Group **Description:** For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00. Endometrial scratch with Shepard catheter: For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00. **ID:** OG001 **Title:** Endometrial Scratch With Shepard Catheter #### Outcome Measure 3 **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** Collected up to 1 year after the last embryo transfer **Title:** Number (Count) of Positive Pregnancy Tests Per Number of Subjects Undergoing Embryo Transfer **Type:** SECONDARY **Unit of Measure:** positive pregnancy tests ##### Group **Description:** For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion. Endometrial scratch with Pipelle curette: For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion. **ID:** OG000 **Title:** Endometrial Scratch With Pipelle Curette ##### Group **Description:** For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00. Endometrial scratch with Shepard catheter: For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00. **ID:** OG001 **Title:** Endometrial Scratch With Shepard Catheter #### Outcome Measure 4 **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** Collected up to 1 year after the last embryo transfer **Title:** Number (Count) of Pregnancies Per Number of Patients Undergoing Embryo Transfer **Type:** SECONDARY **Unit of Measure:** number of pregnancies ##### Group **Description:** For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion. Endometrial scratch with Pipelle curette: For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion. **ID:** OG000 **Title:** Endometrial Scratch With Pipelle Curette ##### Group **Description:** For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00. Endometrial scratch with Shepard catheter: For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00. **ID:** OG001 **Title:** Endometrial Scratch With Shepard Catheter ### Participant Flow Module #### Group **Description:** For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion. Endometrial scratch with Pipelle curette: For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion. **ID:** FG000 **Title:** Endometrial Scratch With Pipelle Curette #### Group **Description:** For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00. Endometrial scratch with Shepard catheter: For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00. **ID:** FG001 **Title:** Endometrial Scratch With Shepard Catheter #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 78 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 92 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 78 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 92 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 0 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT03407079 **Brief Title:** Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study) **Official Title:** Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study) #### Organization Study ID Info **ID:** 180047 #### Organization **Class:** NIH **Full Name:** National Institutes of Health Clinical Center (CC) #### Secondary ID Infos **ID:** 18-AA-0047 ### Status Module #### Completion Date **Date:** 2025-08-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-18 **Overall Status:** SUSPENDED #### Primary Completion Date **Date:** 2025-08-01 **Type:** ESTIMATED #### Start Date **Date:** 2018-04-05 **Type:** ACTUAL **Status Verified Date:** 2024-05-16 #### Study First Post Date **Date:** 2018-01-23 **Type:** ACTUAL **Study First Submit Date:** 2018-01-20 **Study First Submit QC Date:** 2018-01-20 **Why Stopped:** The status was on admin hold with the prev. PI. The new PI (Dr. Joseph) would like to continue to keep the study on admin hold until after reviewing the study ### Sponsor Collaborators Module #### Lead Sponsor **Class:** NIH **Name:** National Institute on Alcohol Abuse and Alcoholism (NIAAA) #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Background: Artificial sweeteners like sucralose are found in many foods and drinks. Sucralose might affect hormones and cause health changes. Objective: To see if sucralose changes how medicines are absorbed and processed, how hormones are secreted, gut bacteria, and how fat cells are metabolized. Eligibility: People ages 18-60 who: * Are black or Hispanic * Weigh more than 110 pounds * Have a body mass index of 25-40 * Do not have a condition that requires drug treatment Design: Participants will be screened with: * Medical history * Physical exam * Blood, heart, and urine tests Participants must not eat or drink anything with artificial sweeteners throughout the study. Over 7 days, Participants will answer questions, and give daily urine samples and 1 stool sample. Participants will repeat these throughout the study. Overnight Visit 1: participants will fast starting the night before. They will get breakfast at the visit. The visit includes: * An IV will be placed in the arm. Participants will get 2 tablets of medicines. Blood will be drawn several times over 24 hours. * A piece of fat tissue may be taken from the abdomen (biopsy). * Participants will have a sweet drink. Blood samples will be taken over 2 hours. Then participants will be randomly assigned to take either a sucralose capsule or placebo. They will take it twice a day for 2 weeks. They will complete two 24-hour food diaries. Overnight Visit 2 repeats Visit 1 except the biopsy. Then participants will take the capsules for another 2 weeks. Overnight Visit 3 repeats Visit 1. Participants may be contacted by phone within 4 weeks after they finish. **Detailed Description:** Background: Consumption of non-nutritive sweeteners (NNS) has dramatically increased worldwide and is more prevalent in women than men. Similarly, obesity rates have continued to rise, most notably in minorities. Since NNS consumption has been linked to obesity, we propose studying NNS effects specifically in minority women. NNS are frequently consumed in combination with prescription medications. This necessitates the study of possible NNS-drug interactions. The hypothesis that NNS may affect drug absorption and metabolism is based on a rodent study. In 2008, Abou-Donia et al reported that sucralose increased the activity of P-glycoprotein (P-gp), a membrane transporter involved in absorption and distribution of a wide range of pharmacologic compounds, and CYP3A, a cytochrome P-450 enzyme important to the first-pass metabolism of many drugs. So far, NNS effects in clinical studies were mostly observed after acute (one time) or short term exposure. For example, we and others found increased incretin and insulin concentrations in response to sucralose alone or in combination with acesulfame-potassium prior to a glucose load. The effects were most pronounced in obese African American women. We also found upregulation of inflammatory cytokines in subcutaneous fat biopsies of obese individuals who reported consumption of NNS compared to non-consumers. Whether these hormonal and tissue responses persist after prolonged exposure needs to be investigated. NNS have also been shown to influence the microbial composition of the oral cavity and the gut. However, most data were generated in mice and do not exist in humans. Aims: Primary Aim: To determine the effects of sucralose (4 mg/kg/day) administered to overweight and obese minority women for 28 days on drug metabolism using digoxin and midazolam as probes for P-glycoprotein and CYP3A, respectively. Secondary Aims: To investigate the effects of sucralose on 1. glucose metabolism and incretin secretion 2. lipid metabolism 3. intestinal microflora Methods: The study consists of 3 periods. In the first period (run-in, 7 days), participants will be instructed to avoid all NNS (including NNS in cosmetics or health care products). During the second and third periods (14 days each), participants will be randomized to consume either sucralose containing capsules (4 mg/kg/day) or placebo. At the end of each period, the following measurements will be obtained during an overnight hospitalization: 1. Serial measurements of plasma concentrations of midazolam and digoxin for 24 hours following a single oral dose of each drug 2. Frequently sampled 2-hour oral glucose tolerance test (OGTT) to measure glucose, insulin, C-peptide, GLP-1, and other gut hormones. At the end of P1 (run-in, no intervention) and after P3 (sucralose exposure x 4 weeks), subcutaneous fat biopsies will be performed. Stool samples will be obtained throughout. ### Conditions Module **Conditions:** - Healthy Volunteers - Overweight **Keywords:** - Drug Metabolism - Artificial Sweetener - P-Glycoprotein - Cytochrome P450 - Microbiome ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 26 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive sucralose capsules (approximately 4mg/kg/day) by mouth for 28 days. **Intervention Names:** - Other: Sucralose **Label:** Study Arm 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive placebo capsules by mouth for 28 days. **Intervention Names:** - Other: Placebo **Label:** Study Arm 2 **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Study Arm 1 **Description:** Sucralose is an organochlorine and is approximately 600 times sweeter than sucrose. Participants will receive sucralose (approximately 4mg/kg/day) or placebo by mouth in a capsule for 28 days. This dose corresponds to the amount of sucralose contained in approximately 3 or 4 twelve ounce cans of commercially-available diet soda for a 70 kg adult. **Name:** Sucralose **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Study Arm 2 **Description:** Placebo capsules will be taken orally for 28 days **Name:** Placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** To determine the effects of sucralose (4 mg/kg/day) administered to overweight and obese minority women for 28 days on drug metabolism using digoxin and midazolam as probes for P-glycoprotein and CYP3A, respectively. **Measure:** To explore the effects of sucralose (approx 4 mg/kg x 28 days) on pharmacokinetics of digoxin and midazolam, which are representative examples of P-gp and CYP3A dependent medications. **Time Frame:** 28 days #### Secondary Outcomes **Description:** We also aim to determine if consumption of \~4 mg/kg sucralose over a 28-day period leads to: 1)changes in glycemia and glucose stimulated secretion of GLP-1 and other gut hormones during an oral glucose tolerance test (OGTT) 2)changes in lipid metabolism (in vitro (adipose tissue) and in vivo (fasting and during OGTT) 3)alterations in the intestinal microflora **Measure:** To investigate the effects of sucralose on glucose metabolism and incretin secretion, lipid metabolism, and intestinal microbiome **Time Frame:** 28 days ### Eligibility Module **Eligibility Criteria:** * INCLUSION CRITERIA: 1. Age: between 18 and 60 years 2. Female adults who self-identify as Hispanic and/or Black 3. Body weight greater than 50 kg (110 lb) 4. Body mass index between 25 kg/m\^2 and 40 kg/m\^2 5. Consumption of less than or equal to one 12-ounce beverage sweetened with NNS per month or food equivalent 6. Healthy with no known active medical condition or illness that requires drug treatment 7. Able and willing to consume approximately 4 mg/kg sucralose daily or placebo in form of capsules for 4 weeks 8. Able and willing to avoid eating grapefruit, parsnips, celery, drinking grapefruit juice or sodas containing quinine (e.g. tonic water) during the study 9. Able and willing to collect stool specimens 10. Able and willing to consume digoxin and midazolam during study visits EXCLUSION CRITERIA: 1. Current use of prescription or non-prescription medication(s), herbal medications and oral contraceptives are also excluded. Certain exceptions are permitted, including vitamins. Other medications may be permitted at the discretion of the investigators. 2. Diabetes (fasting blood glucose of 126 mg/dl or higher, or 2-hour blood glucose of 200 or higher on OGTT) 3. Taken medications that affect blood sugar in the past 3 months or that include antibiotics 4. GI history, at the discretion of the investigators 5. Known allergy, sensitivity, or other contraindication to study procedures 6. ALT or AST more than 1.5 times the upper limit of normal 7. Abnormal thyroid function or abnormal serum electrolytes \& minerals (specifically potassium, calcium, and magnesium) 8. Narrow angle glaucoma or untreated open angle glaucoma 9. Regular use of alcohol (more than 1 drink per day) or drug use 10. History of cardiac abnormalities, especially arrhythmia 11. Unable or unwilling to cooperate with study procedures 12. Psychiatric or cognitive disorder that will, in the opinion of the investigators, limit the subject's ability to provide informed consent, or to comply with study procedures 13. Pregnant, planning to become pregnant or lactating (digoxin and midazolam are Category C and D medications, respectively). **Healthy Volunteers:** True **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bethesda **Country:** United States **Facility:** National Institutes of Health Clinical Center **State:** Maryland **Zip:** 20892 #### Overall Officials **Official 1:** **Affiliation:** National Institute on Alcohol Abuse and Alcoholism (NIAAA) **Name:** Paule V Joseph, C.R.N.P. **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Abou-Donia MB, El-Masry EM, Abdel-Rahman AA, McLendon RE, Schiffman SS. Splenda alters gut microflora and increases intestinal p-glycoprotein and cytochrome p-450 in male rats. J Toxicol Environ Health A. 2008;71(21):1415-29. doi: 10.1080/15287390802328630. **PMID:** 18800291 **Citation:** Sylvetsky AC, Brown RJ, Blau JE, Walter M, Rother KI. Hormonal responses to non-nutritive sweeteners in water and diet soda. Nutr Metab (Lond). 2016 Oct 21;13:71. doi: 10.1186/s12986-016-0129-3. eCollection 2016. **PMID:** 27777606 **Citation:** Suez J, Korem T, Zeevi D, Zilberman-Schapira G, Thaiss CA, Maza O, Israeli D, Zmora N, Gilad S, Weinberger A, Kuperman Y, Harmelin A, Kolodkin-Gal I, Shapiro H, Halpern Z, Segal E, Elinav E. Artificial sweeteners induce glucose intolerance by altering the gut microbiota. Nature. 2014 Oct 9;514(7521):181-6. doi: 10.1038/nature13793. Epub 2014 Sep 17. **PMID:** 25231862 #### See Also Links **Label:** NIH Clinical Center Detailed Web Page **URL:** https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2018-AA-0047.html ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M26186 - Name: Overweight - Relevance: HIGH - As Found: Overweight - ID: M25307 - Name: Overnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000050177 - Term: Overweight ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M340819 - Name: polysaccharide-K - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05501379 **Acronym:** OncoPhys **Brief Title:** Comparison of the Physical Activity in Cancer Patients Assessed by Questionnaire and Motion Tracker **Official Title:** Comparison of the Physical Activity Assessed by an Accelerometer and the International Physical Activity Questionnaire in Oncologic Patients #### Organization Study ID Info **ID:** BB 067/22 #### Organization **Class:** OTHER **Full Name:** University Medicine Greifswald ### Status Module #### Completion Date **Date:** 2024-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-09 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-08 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07 **Type:** ESTIMATED #### Start Date **Date:** 2022-09-21 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2022-08-15 **Type:** ACTUAL **Study First Submit Date:** 2022-08-11 **Study First Submit QC Date:** 2022-08-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Medicine Greifswald #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Physical activity is an important aspect of cancer therapy but correct measurement of physical activity is difficult. In this study, the physical activity of patients undergoing cancer therapy is assessed by questionnaire and by motion tracker. The results are then compared to answer whether there are differences between the two measurements. Findings of this study will help to improve the assessment of physical activity in cancer patients. **Detailed Description:** Although physical activity has been identified as a relevant determinant of cancer therapy outcome, its valid assessment remains challenging. In principle, direct and indirect assessment instruments can be employed for assessment of physical activity. While direct instruments, e.g. accelerometers, are considered to provide a more objective measurement, indirect tools such as questionnaires are less expensive and more applicable for use in larger study populations. The validity of both forms of measurements in cancer patients is however not well studied. Therefore, this study aims to elucidate the relative validity of an accelerometer in comparison to a standardized physical questionnaire at different time points of cancer therapy. Findings of this study will allow conclusions regarding the ideal modalities for assessment of physical activity in cancer patients. ### Conditions Module **Conditions:** - Lymphoma - Pancreas Cancer - Colorectal Cancer **Keywords:** - Physical Activity - Accelerometer - International Physical Activity Questionnaire - Cancer Therapy - GeneActiv - Quality of Life - Fatigue ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with a verified diagnosis of lymphoma, colorectal or pancreatic cancer requiring surgical, chemo or radio therapy. **Intervention Names:** - Other: No intervention - observational study only **Label:** Cancer Patients ### Interventions #### Intervention 1 **Arm Group Labels:** - Cancer Patients **Description:** No intervention - observational study only **Name:** No intervention - observational study only **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Difference in physical activity measured by the GeneActiv accelerometer and the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) **Measure:** Comparison of physical activity assessments within 1 week after initiation of cancer therapy **Time Frame:** 1 week after initiation of cancer therapy #### Secondary Outcomes **Description:** Difference in physical activity measured by the GeneActiv accelerometer and the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) **Measure:** Comparison of physical activity assessments 12 weeks after initiation of cancer therapy **Time Frame:** 12 weeks after initiation of cancer therapy **Description:** Difference in changes of physical activity measured by the GeneActiv accelerometer and the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) **Measure:** Comparison of changes in physical activity between assessements within 1 week and 12 weeks after initiation of cancer therapy **Time Frame:** 12 weeks after initiation of cancer therapy **Description:** Physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs) **Measure:** Physical activity assessed by accelerometer **Time Frame:** 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy **Description:** Physical activity measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) **Measure:** Physical activity assessed by questionnaire **Time Frame:** 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy **Description:** Association between ECOG Performance Status and physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs) **Measure:** Relation of Eastern Co-operative Oncology Group (ECOG) Performance Status to physical activity assessed by accelerometer **Time Frame:** 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy **Description:** Association between ECOG Performance Status and physical activity measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) **Measure:** Relation of Eastern Co-operative Oncology Group (ECOG) Performance Status to physical activity assessed by questionnaire **Time Frame:** 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy **Description:** Association between KPS and physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs) **Measure:** Relation of Karnofsky Performance Status (KPS) to physical activity assessed by accelerometer **Time Frame:** 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy **Description:** Association between KPS and physical activity measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) **Measure:** Relation of Karnofsky Performance Status (KPS) to physical activity assessed by questionnaire **Time Frame:** 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy **Description:** Association between age and physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs) **Measure:** Relation of age to physical activity assessed by accelerometer **Time Frame:** 1 week after initiation of cancer therapy **Description:** Association between age and physical activity measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) **Measure:** Relation of age to physical activity assessed by questionnaire **Time Frame:** 1 week after initiation of cancer therapy **Description:** Association between sex and physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs) **Measure:** Relation of sex to physical activity assessed by accelerometer **Time Frame:** 1 week after initiation of cancer therapy **Description:** Association between sex and physical activity measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) **Measure:** Relation of sex to physical activity assessed by questionnaire **Time Frame:** 1 week after initiation of cancer therapy **Description:** Association between quality of life assessed by the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ C-30) and physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs) **Measure:** Relation of quality of life to physical activity assessed by accelerometer **Time Frame:** 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy **Description:** Association between quality of life assessed by the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ C-30) and physical activity measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) **Measure:** Relation of quality of life to physical activity assessed by questionnaire **Time Frame:** 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy **Description:** Association between quality of life assessed by the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ C-30) and cancer therapy modality **Measure:** Therapy-related quality of life **Time Frame:** 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy **Description:** Association between fatigue assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Fatigue Questionnaire (EORTC QLQFA-12) and physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs) **Measure:** Relation of fatigue to physical activity assessed by accelerometer **Time Frame:** 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy **Description:** Association between fatigue assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Fatigue Questionnaire (EORTC QLQFA-12) and physical activity measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) **Measure:** Relation of fatigue to physical activity assessed by questionnaire **Time Frame:** 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy **Description:** Association between fatigue assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Fatigue Questionnaire (EORTC QLQFA-12) and cancer therapy modality **Measure:** Therapy-related fatigue **Time Frame:** 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy **Description:** Association between sleep duration measured by the GeneActiv accelerometer in hours and physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs) **Measure:** Relation of sleep duration to physical activity assessed by accelerometer **Time Frame:** 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy **Description:** Association between sleep duration measured by the GeneActiv accelerometer in hours and physical activity measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) **Measure:** Relation of sleep duration to physical activity assessed by questionnaire **Time Frame:** 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy **Description:** Association between sleep efficiency, i.e. the ratio of sleep duration to total bed time measured by the GeneActiv accelerometer in hours, and physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs) **Measure:** Relation of sleep efficiency to physical activity assessed by accelerometer **Time Frame:** 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy **Description:** Association between sleep efficiency, i.e. the ratio of sleep duration to total bed time measured by the GeneActiv accelerometer in hours, and physical activity measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) **Measure:** Relation of sleep efficiency to physical activity assessed by questionnaire **Time Frame:** 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy **Description:** Association between sleep duration measured by the GeneActiv accelerometer in hours and cancer therapy modality **Measure:** Therapy-related sleep duration **Time Frame:** 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy **Description:** Association between sleep efficiency, i.e. the ratio of sleep duration to total bed time measured by the GeneActiv accelerometer in hours, and cancer therapy modality **Measure:** Therapy-related sleep efficiency **Time Frame:** 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy **Description:** Differences in fatigue assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Fatigue Questionnaire (EORTC QLQFA-12) **Measure:** Changes in fatigue between assessements before and 12 weeks after initiation of cancer therapy **Time Frame:** 12 weeks after initiation of cancer therapy **Description:** Differences in quality of life assessed by the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ C-30) **Measure:** Changes in quality of life between assessements before and 12 weeks after initiation of cancer therapy **Time Frame:** 12 weeks after initiation of cancer therapy **Description:** Association between tumor entity and changes in physical activity measured by the GeneActiv accelerometer and the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) **Measure:** Relation of tumor entity to changes in physical activity between assessements within 1 week and 12 weeks after initiation of cancer therapy **Time Frame:** 12 weeks after initiation of cancer therapy **Description:** Association between cancer therapy modality and changes in physical activity measured by the GeneActiv accelerometer and the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) **Measure:** Relation of cancer therapy modality to changes in physical activity between assessements within 1 week and 12 weeks after initiation of cancer therapy **Time Frame:** 12 weeks after initiation of cancer therapy ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * verified diagnosis of lymphoma, colorectal or pancreatic cancer * requirement of surgical, chemo or radio therapy * provision of informed consent Exclusion Criteria: * pregnancy * inability to provide consent * use of a rollator **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients will be recruited at University Medicine Greifswald (Northeast Germany). Patients with the verified diagnosis of lymphoma, colerectal or pancreatic cancer requiring surgical, chemo or radio therapy will be identified in the respective wards or day care units of the hosptial. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ali A Aghdassi, Professor **Phone:** +493834867230 **Role:** CONTACT #### Locations **Location 1:** **City:** Greifswald **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ali A Aghdassi, Professor - **Phone:** +493834867230 - **Role:** CONTACT ***Contact 2:*** - **Name:** Ali A Aghdassi, Professor - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Mats L Wiese, MSc - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Sebastian Schmidt - **Role:** SUB_INVESTIGATOR **Country:** Germany **Facility:** University Medicine Greifswald **Status:** RECRUITING **Zip:** 17475 #### Overall Officials **Official 1:** **Affiliation:** University Medicine Greifswald **Name:** Ali A Aghdassi, Professor **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000010182 - Term: Pancreatic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13110 - Name: Pancreatic Neoplasms - Relevance: HIGH - As Found: Pancreas Cancer - ID: M11220 - Name: Lymphoma - Relevance: LOW - As Found: Unknown - ID: M8364 - Name: Fatigue - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M13102 - Name: Pancreatic Diseases - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown - ID: T4387 - Name: Pancreatic Cancer - Relevance: LOW - As Found: Unknown - ID: T3543 - Name: Lymphosarcoma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010190 - Term: Pancreatic Neoplasms ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04673279 **Brief Title:** Long-term COVID-19 Immune Response in a Vulnerable Neighbourhood in Argentina **Official Title:** Long-term Persistence of Immunoglobulin G Antibodies Against Severe Acute Respiratory Syndrome Coronavirus 2 in a Vulnerable Neighbourhood in Buenos Aires, Argentina #### Organization Study ID Info **ID:** 3545 #### Organization **Class:** OTHER **Full Name:** Hospital Italiano de Buenos Aires ### Status Module #### Completion Date **Date:** 2021-08-20 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-08-25 **Type:** ACTUAL **Last Update Submit Date:** 2021-08-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-08-20 **Type:** ACTUAL #### Start Date **Date:** 2020-12-02 **Type:** ACTUAL **Status Verified Date:** 2021-08 #### Study First Post Date **Date:** 2020-12-17 **Type:** ACTUAL **Study First Submit Date:** 2020-12-13 **Study First Submit QC Date:** 2020-12-16 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Hospital de Niños R. Gutierrez de Buenos Aires **Class:** UNKNOWN **Name:** Ministerio de Salud GCBA #### Lead Sponsor **Class:** OTHER **Name:** Hospital Italiano de Buenos Aires #### Responsible Party **Investigator Affiliation:** Hospital Italiano de Buenos Aires **Investigator Full Name:** ALICIA MISTCHENKO **Investigator Title:** principal investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Between June 10t h and July 1st, a cross-sectional design study in an Argentina slum, showed a prevalence based on immunoglobuling G-class (IgG) antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) of 53.4%. It remains unanswered whether natural infection produces sustained antibodies. The aim of this study is to evaluate the presence of IgG antibodies for Coronavirus disease 2019 (COVID-19) after 5 months in inhabitants of Barrio 31 who consented the Seroprevalence Study for COVID-19. **Detailed Description:** Background Between June 10t h and July 1st, a cross-sectional design study was carried out in an Argentina slum over people, selected from a probabilistic sample of households showed a prevalence based on IgG-class antibodies against SARS-CoV-2 of 53.4%. In regarding to the persistence of these antibodies, the early data brought hope that acquired immunity was possible. But some subsequent studies have suggested that immune protection might be short-lived. The new findings show that people who survive a COVID-19 infection continue to produce protective antibodies against key parts of the virus for at least three to four months after developing their first symptoms. In contrast, some other antibody types decline more quickly. It remains unanswered whether natural infection produces a sustained immunity that is capable of establishing herd immunity. The other health problem that Latin America faces is dengue, whose transmission, like SARS-CoV-2, is greater in areas with high population density such as vulnerable neighborhoods. In this context, the occurrence of the two diseases implies a risk, particularly in regions with several dengue serotypes where secondary and tertiary infections have been demonstrated and dengue epidemiological surveillance has been affected by the saturation of health system. Objectives The aim of this study is to evaluate the presence of IgG antibodies for COVID-19 after 5 months in inhabitants of this slum who consented the Seroprevalence Study for COVID-19, and to evaluate those factors associated with the persistence of positive antibodies. As a secondary objective, the presence of positive IgG for dengue will be evaluated. Methods Cross sectional study. Population of the study were inhabitants of the slum: men and women form 14 years of age or older were included. People will be invited to participated and detection of antibodies will be performed with ta serological tests, an enzyme linked immunosorbent assay (ELISA) developed and validated in Argentina which detects antibodies against two viral antigens, trimeric spike and the receptor binding domain (RBD) of the spike protein. Blood sample will be collected in a capillary tube from a finger prick taken at the doorstep of each person. Samples will be processed and analyzed at the "Hospital de Niños Doctor Ricardo Gutierrez" Virology laboratory. Blood sample collection and epidemiological data were collected, and entered in a secure database. Sample Size The first seroprevalence study included 426 inhabitants of 14 years or more. Considering a persistence of antibodies of 30% with a precision of 5% for a confidence interval of 95% 184 inhabitants should be included. This sample will be selected by a proportionate stratified random sampling, considering the ten sectors in which the slum is divided. Statistical analysis Descriptive statistics of the data will be carried out according to the variables obtained. Continuous variables will be expressed as mean and standard deviation, and categorical variables as proportions. A multiple logistic regression model will be performed to evaluate the factors associated with the persistence of positive antibodies for SARS-CoV-2. Dengue seroprevalence is determined globally and by geographic sector. R software version 4.0.2 will be used. ### Conditions Module **Conditions:** - Coronavirus Disease 2019 **Keywords:** - Immunity - serology - antibody - SARS-CoV-2 - COVID-19 - vulnerability ### Design Module #### Bio Spec **Description:** blod samples for antibodies detection against dengue **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 189 **Type:** ACTUAL **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Day ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** An enzyme linked immunosorbent assay (ELISA) developed and validated in Argentina which detects antibodies against two viral antigens, trimeric spike and the receptor binding domain (RBD) of the spike protein. **Name:** serology **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** to estimate the proportion of people with positive IgG antibodies for COVID-19 who have positive IgG antibodies after 5 month of the first measurement **Measure:** to estimate the proportion of people with positive IgG antibodies for COVID-19 who have positive IgG antibodies after 5 month of the first measurement **Time Frame:** up to 20 weeks #### Secondary Outcomes **Description:** to estimate the proportion of people with positive IgG antibodies for dengue **Measure:** to estimate the proportion of people with positive IgG antibodies for dengue **Time Frame:** up to 20 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Men and women form 14 years of age or older who were included in the seroprevalence study and who have positive antibodies against severe acute respiratory syndrome coronavirus 2 Exclusion Criteria: * deny consent **Maximum Age:** 90 Years **Minimum Age:** 14 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** inhabitants of Barrio Mugica: men and women form 14 years of age or older who were included in the first seroprevalence study carried on between Between June 10t h and July 1st, and who have positive antibodies against severe acute respiratory syndrome coronavirus 2 ### Contacts Locations Module #### Locations **Location 1:** **City:** Buenos Aires **Country:** Argentina **Facility:** Hospital de Niños Ricardo Gutierrez **State:** Ciudad De Buenos Aires **Zip:** C1425EFD #### Overall Officials **Official 1:** **Affiliation:** Hospital Italiano de Buenos Aires **Name:** Vanina Pagotto, MD MG **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** Hospital de Niños Ricardo Gutierrez **Name:** Alicia Mistchenko, Phd **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** Hospital Italiano de Buenos Aires **Name:** Silvana Figar, MD MG **Role:** STUDY_CHAIR **Official 4:** **Affiliation:** National Council of Scientific and Technical Research, Argentina **Name:** Andrea Gamarnick, Phd **Role:** STUDY_CHAIR **Official 5:** **Affiliation:** Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires **Name:** Ana Maria Gomez Saldaño, MD MG **Role:** STUDY_CHAIR **Official 6:** **Affiliation:** Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires **Name:** Lorena Luna **Role:** STUDY_CHAIR **Official 7:** **Affiliation:** Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires **Name:** Julieta Salto **Role:** STUDY_CHAIR **Official 8:** **Affiliation:** Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires **Name:** Magdalena Wagner Manslau **Role:** STUDY_CHAIR **Official 9:** **Affiliation:** Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires **Name:** Fernan Quiroz, MD MG **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Jordan RE, Adab P, Cheng KK. Covid-19: risk factors for severe disease and death. BMJ. 2020 Mar 26;368:m1198. doi: 10.1136/bmj.m1198. No abstract available. **PMID:** 32217618 **Citation:** Long QX, Tang XJ, Shi QL, Li Q, Deng HJ, Yuan J, Hu JL, Xu W, Zhang Y, Lv FJ, Su K, Zhang F, Gong J, Wu B, Liu XM, Li JJ, Qiu JF, Chen J, Huang AL. Clinical and immunological assessment of asymptomatic SARS-CoV-2 infections. Nat Med. 2020 Aug;26(8):1200-1204. doi: 10.1038/s41591-020-0965-6. Epub 2020 Jun 18. **PMID:** 32555424 **Citation:** Kellam P, Barclay W. The dynamics of humoral immune responses following SARS-CoV-2 infection and the potential for reinfection. J Gen Virol. 2020 Aug;101(8):791-797. doi: 10.1099/jgv.0.001439. **PMID:** 32430094 **Citation:** Wilder-Smith A, Tissera H, Ooi EE, Coloma J, Scott TW, Gubler DJ. Preventing Dengue Epidemics during the COVID-19 Pandemic. Am J Trop Med Hyg. 2020 Aug;103(2):570-571. doi: 10.4269/ajtmh.20-0480. Epub 2020 Jun 15. No abstract available. **PMID:** 32539912 **Citation:** Cardoso MR, Cousens SN, de Goes Siqueira LF, Alves FM, D'Angelo LA. Crowding: risk factor or protective factor for lower respiratory disease in young children? BMC Public Health. 2004 Jun 3;4:19. doi: 10.1186/1471-2458-4-19. **PMID:** 15176983 #### See Also Links **Label:** 2019 Novel Coronavirus (COVID-19) Pneumonia with Hemoptysis as the Initial Symptom: CT and Clinical Features **URL:** http://dx.doi.org/10.3348/kjr.2020.0181 **Label:** SARS-CoV-2 infection induces sustained humoral immune responses in convalescent patients following symptomatic COVID-19 **URL:** http://dx.doi.org/10.1101/2020.07.21.20159178 **Label:** Community-level SARS-CoV-2 Seroprevalence Survey in urban slum dwellers of Buenos Aires City, Argentina: a participatory research. **URL:** https://www.medrxiv.org/content/10.1101/2020.07.14.20153858v2.full.pdf **Label:** Reductions in commuting mobility correlate with geographic differences in SARS-CoV-2 prevalence in New York City **URL:** https://doi.org/10.1038/s41467-020-18271-5 **Label:** The COVID-19 pandemic should not jeopardize dengue control **URL:** https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0008716 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003333 - Term: Coronaviridae Infections - ID: D000030341 - Term: Nidovirales Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000014777 - Term: Virus Diseases - ID: D000007239 - Term: Infections - ID: D000011024 - Term: Pneumonia, Viral - ID: D000011014 - Term: Pneumonia - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M2561 - Name: COVID-19 - Relevance: HIGH - As Found: Coronavirus Disease 2019 - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M20490 - Name: Coronavirus Infections - Relevance: HIGH - As Found: Coronavirus - ID: M25445 - Name: Severe Acute Respiratory Syndrome - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M6555 - Name: Coronaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M23685 - Name: Nidovirales Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M13904 - Name: Pneumonia - Relevance: LOW - As Found: Unknown - ID: M13914 - Name: Pneumonia, Viral - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T5186 - Name: Severe Acute Respiratory Syndrome - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000018352 - Term: Coronavirus Infections - ID: D000086382 - Term: COVID-19 ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M10122 - Name: Immunoglobulin G - Relevance: LOW - As Found: Unknown - ID: M19117 - Name: Immunoglobulins, Intravenous - Relevance: LOW - As Found: Unknown - ID: M12147 - Name: Myeloma Proteins - Relevance: LOW - As Found: Unknown - ID: M13179 - Name: Paraproteins - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01052779 **Acronym:** FIRST **Brief Title:** A Trial Comparing Ferumoxytol to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease **Official Title:** Ferumoxytol Compared to Iron Sucrose Trial (FIRST): A Randomized, Multicenter, Trial of Ferumoxytol Compared to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease #### Organization Study ID Info **ID:** FER-CKD-201 #### Organization **Class:** INDUSTRY **Full Name:** AMAG Pharmaceuticals, Inc. #### Secondary ID Infos **ID:** 2009-015630-30 **Type:** EUDRACT_NUMBER ### Status Module #### Completion Date **Date:** 2012-04-19 **Type:** ACTUAL #### Disp First Post Date **Date:** 2013-04-10 **Type:** ESTIMATED **Disp First Submit Date:** 2013-04-03 **Disp First Submit QC Date:** 2013-04-03 #### Expanded Access Info #### Last Update Post Date **Date:** 2023-07-25 **Type:** ACTUAL **Last Update Submit Date:** 2023-07-18 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2011-07-19 **Type:** ACTUAL #### Results First Post Date **Date:** 2018-05-15 **Type:** ACTUAL **Results First Submit Date:** 2018-03-26 **Results First Submit QC Date:** 2018-05-10 #### Start Date **Date:** 2010-03-01 **Type:** ACTUAL **Status Verified Date:** 2023-07 #### Study First Post Date **Date:** 2010-01-20 **Type:** ESTIMATED **Study First Submit Date:** 2010-01-15 **Study First Submit QC Date:** 2010-01-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** AMAG Pharmaceuticals, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of the study is to evaluate the safety and efficacy of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA) in participants with chronic kidney disease (CKD). ### Conditions Module **Conditions:** - Iron Deficiency - Anemia - Kidney Disease **Keywords:** - Iron deficiency anemia - Chronic kidney disease - Feraheme - Ferumoxytol - Iron sucrose - IDA - CKD - Venofer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 162 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants received an IV injection of ferumoxytol (510 milligrams \[mg\], 17 milliliters \[mL\]) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 grams (g). **Intervention Names:** - Drug: Ferumoxytol **Label:** Ferumoxytol **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g. Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g. **Intervention Names:** - Drug: Iron Sucrose **Label:** Iron Sucrose **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Ferumoxytol **Description:** IV Ferumoxytol **Name:** Ferumoxytol **Other Names:** - Feraheme **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Iron Sucrose **Description:** IV Iron Sucrose **Name:** Iron Sucrose **Other Names:** - Venofer **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The change in hemoglobin from Baseline (Day 1) to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline) The least squares mean, with standard error, is reported as g/deciliter (dL). Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug). The screening hemoglobin value was used for any participants with missing Baseline (Day 1) hemoglobin. Analysis used last observed carried forward (LOCF) imputation methods for missing values for the ITT population. Sensitivity analyses were performed without imputation for missing data and with the Markov chain Monte Carlo method. **Measure:** Mean Change In Hemoglobin From Baseline (Day 1) To Week 5 **Time Frame:** Baseline (Day 1), Week 5 **Description:** The percentage of participants who achieved a ≥1.0 g/dL increase in hemoglobin at any time from Baseline (Day 1) up to Week 5 by treatment group is presented by study visit. Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug). **Measure:** Percentage Of Participants With An Increase In Hemoglobin ≥1.0 g/dL From Day 1 (Baseline) To Week 5 **Time Frame:** Baseline (Day 1) and up to Week 5 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Key Inclusion Criteria include: 1. Males and females ≥18 years of age 2. An estimated glomerular filtration rate \<60 mL/minute or a diagnosis of CKD (such as nephropathy, nephritis) 3. Hemoglobin \<11.0 g/deciliter (dL) 4. Transferrin saturation \<30% 5. Hemodialysis participants on maintenance dialysis for at least 3 months prior to screening and currently receiving dialysis 3 times per week 6. Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of the study Exclusion Criteria: Key Exclusion Criteria include: 1. History of allergy to IV iron 2. Allergy to 2 or more classes of drugs 3. Female participants who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test 4. Hemoglobin ≤7.0 g/dL 5. Received another investigational agent within 4 weeks prior to screening, or planned receipt of an unspecified investigational agent during the study period 6. Known causes of anemia other than iron deficiency (such as hemolysis and vitamin B12 or folate deficiency) **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Tempe **Country:** United States **Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **State:** Arizona **Zip:** 85284 **Location 2:** **City:** Chula Vista **Country:** United States **Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **State:** California **Zip:** 91910 **Location 3:** **City:** Mountain View **Country:** United States **Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **State:** California **Zip:** 94041 **Location 4:** **City:** Whittier **Country:** United States **Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **State:** California **Zip:** 90602 **Location 5:** **City:** Augusta **Country:** United States **Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **State:** Georgia **Zip:** 30901 **Location 6:** **City:** Meridian **Country:** United States **Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **State:** Idaho **Zip:** 83642 **Location 7:** **City:** Evergreen Park **Country:** United States **Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **State:** Illinois **Zip:** 60805 **Location 8:** **City:** Shreveport **Country:** United States **Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **State:** Louisiana **Zip:** 71101 **Location 9:** **City:** Bethesda **Country:** United States **Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **State:** Maryland **Location 10:** **City:** Springfield **Country:** United States **Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **State:** Massachusetts **Zip:** 01107 **Location 11:** **City:** Flushing **Country:** United States **Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **State:** New York **Zip:** 11355 **Location 12:** **City:** Rosedale **Country:** United States **Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **State:** New York **Location 13:** **City:** Bethlehem **Country:** United States **Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **State:** Pennsylvania **Zip:** 18017 **Location 14:** **City:** San Antonio **Country:** United States **Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **State:** Texas **Zip:** 78229 **Location 15:** **City:** Antwerpen **Country:** Belgium **Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **Zip:** 2020 **Location 16:** **City:** Antwerpen **Country:** Belgium **Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **Zip:** 2060 **Location 17:** **City:** Vancouver **Country:** Canada **Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **State:** British Columbia **Location 18:** **City:** Richmond Hill **Country:** Canada **Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **State:** Ontario **Location 19:** **City:** Montréal **Country:** Canada **Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **State:** Quebec **Zip:** H3A 1A1 **Location 20:** **City:** Montréal **Country:** Canada **Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **State:** Quebec **Zip:** H4J 1C5 **Location 21:** **City:** Berlin **Country:** Germany **Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **Location 22:** **City:** Düsseldorf **Country:** Germany **Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **Location 23:** **City:** Göttingen **Country:** Germany **Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **Location 24:** **City:** Munich **Country:** Germany **Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **Location 25:** **City:** Nürnberg **Country:** Germany **Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **Location 26:** **City:** Passau **Country:** Germany **Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **Location 27:** **City:** Bangalore **Country:** India **Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **Location 28:** **City:** Nagpur **Country:** India **Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **Location 29:** **City:** Pune **Country:** India **Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **Location 30:** **City:** Katowice **Country:** Poland **Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **Location 31:** **City:** Opole **Country:** Poland **Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **Location 32:** **City:** Radom **Country:** Poland **Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **Location 33:** **City:** Szczecin **Country:** Poland **Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **Location 34:** **City:** Warszawa **Country:** Poland **Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **Location 35:** **City:** Łódź **Country:** Poland **Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. **Location 36:** **City:** London **Country:** United Kingdom **Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. ### References Module #### References **Citation:** Hetzel D, Strauss W, Bernard K, Li Z, Urboniene A, Allen LF. A Phase III, randomized, open-label trial of ferumoxytol compared with iron sucrose for the treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy. Am J Hematol. 2014 Jun;89(6):646-50. doi: 10.1002/ajh.23712. **PMID:** 24639149 **Citation:** Strauss WE, Dahl NV, Li Z, Lau G, Allen LF. Ferumoxytol versus iron sucrose treatment: a post-hoc analysis of randomized controlled trials in patients with varying renal function and iron deficiency anemia. BMC Hematol. 2016 Jul 26;16:20. doi: 10.1186/s12878-016-0060-x. eCollection 2016. **PMID:** 27462400 **Citation:** Macdougall IC, Strauss WE, McLaughlin J, Li Z, Dellanna F, Hertel J. A randomized comparison of ferumoxytol and iron sucrose for treating iron deficiency anemia in patients with CKD. Clin J Am Soc Nephrol. 2014 Apr;9(4):705-12. doi: 10.2215/CJN.05320513. Epub 2014 Jan 23. **PMID:** 24458078 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000006402 - Term: Hematologic Diseases - ID: D000051437 - Term: Renal Insufficiency - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000019189 - Term: Iron Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000000747 - Term: Anemia, Hypochromic ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: HIGH - As Found: Kidney Disease - ID: M20857 - Name: Anemia, Iron-Deficiency - Relevance: HIGH - As Found: Iron Deficiency - ID: M2781 - Name: Iron Deficiencies - Relevance: HIGH - As Found: Iron Deficiency - ID: M4070 - Name: Anemia - Relevance: HIGH - As Found: Anemia - ID: M26717 - Name: Renal Insufficiency, Chronic - Relevance: HIGH - As Found: Chronic Kidney Disease - ID: M26718 - Name: Renal Insufficiency - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M21177 - Name: Iron Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M4077 - Name: Anemia, Hypochromic - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007674 - Term: Kidney Diseases - ID: D000051436 - Term: Renal Insufficiency, Chronic - ID: D000000740 - Term: Anemia - ID: D000018798 - Term: Anemia, Iron-Deficiency - ID: D000090463 - Term: Iron Deficiencies ### Intervention Browse Module - Ancestors - ID: D000006397 - Term: Hematinics - ID: D000057947 - Term: Parenteral Nutrition Solutions - ID: D000019999 - Term: Pharmaceutical Solutions ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Hemat - Name: Hematinics - Abbrev: PhSol - Name: Pharmaceutical Solutions ### Intervention Browse Module - Browse Leaves - ID: M10533 - Name: Iron - Relevance: LOW - As Found: Unknown - ID: M1861 - Name: Ferric Oxide, Saccharated - Relevance: HIGH - As Found: HIV Prevention - ID: M26996 - Name: Ferrosoferric Oxide - Relevance: HIGH - As Found: Microspheres - ID: M9485 - Name: Hematinics - Relevance: LOW - As Found: Unknown - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M28934 - Name: Parenteral Nutrition Solutions - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000052203 - Term: Ferrosoferric Oxide - ID: D000077605 - Term: Ferric Oxide, Saccharated ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Ferumoxytol **Description:** Participants received an IV injection of ferumoxytol (510 mg, 17 mL) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 g. **ID:** EG000 **Other Num Affected:** 35 **Other Num at Risk:** 80 **Serious Number Affected:** 7 **Serious Number At Risk:** 80 **Title:** Ferumoxytol **Group ID:** EG001 **Title:** Iron Sucrose **Description:** Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g. Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g. **ID:** EG001 **Other Num Affected:** 50 **Other Num at Risk:** 82 **Serious Number Affected:** 6 **Serious Number At Risk:** 82 **Title:** Iron Sucrose **Frequency Threshold:** 1 #### Other Events **Term:** Nasopharyngitis **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 13.0 **Term:** Urinary tract infection **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 13.0 **Term:** Muscle spasms **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Myalgia **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Pain in extremity **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Injection site pain **Organ System:** General disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Edema peripheral **Organ System:** General disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Constipation **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Diarrhoea **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Nausea **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Headache **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Parosmia **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Hypotension **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Hyperkalaemia **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Hypoglycaemia **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Cough **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Anaemia **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Vomiting **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Gout **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Dizziness **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Iron deficiency anaemia **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Cerumen impaction **Organ System:** Ear and labyrinth disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Lacrimation increased **Organ System:** Eye disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Abdominal pain upper **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Tooth disorder **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Toothache **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Catheter site erythema **Organ System:** General disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Feeling hot **Organ System:** General disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Injection site haematoma **Organ System:** General disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Tenderness **Organ System:** General disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Chills **Organ System:** General disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Device leakage **Organ System:** General disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Fatigue **Organ System:** General disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Feeling cold **Organ System:** General disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Injection site haemorrhage **Organ System:** General disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Medical device complication **Organ System:** General disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Thrombosis in device **Organ System:** General disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Sinusitis **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 13.0 **Term:** Staphylococcal abscess **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 13.0 **Term:** Urethritis **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 13.0 **Term:** Burn first degree **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 13.0 **Term:** Humerus fracture **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 13.0 **Term:** Procedural hypotension **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 13.0 **Term:** Vascular graft thrombosis **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 13.0 **Term:** Arthropod bite **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 13.0 **Term:** Fall **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 13.0 **Term:** Procedural hypertension **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 13.0 **Term:** Scratch **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 13.0 **Term:** Sunburn **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 13.0 **Term:** Hyperglycaemia **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Hyperkalaemia **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Vitamin D deficiency **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Flank pain **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Back pain **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Bone pain **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Limb discomfort **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Neck pain **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Synovial cyst **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Seborrhoeic keratosis **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 13.0 **Term:** Dysgeusia **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Facial palsy **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Paraesthesia **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Unresponsive to stimuli **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Haematuria **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Nocturia **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Asthma **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Oropharyngeal pain **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Dyspnoea **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Epistaxis **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Rales **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Wheezing **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Ingrowing nail **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Acne **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Cold sweat **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Dry skin **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Ecchymosis **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Skin haemorrhage **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Treatment noncompliance **Organ System:** Social circumstances **Source Vocabulary:** MedDRA 13.0 **Term:** Flushing **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Hot flush **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Hypertension **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Poor veneous access **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 13.0 **Term:** Blood glucose increased **Organ System:** Investigations **Source Vocabulary:** MedDRA 13.0 **Term:** Breath sounds abnormal **Organ System:** Investigations **Source Vocabulary:** MedDRA 13.0 **Term:** Weight increased **Organ System:** Investigations **Source Vocabulary:** MedDRA 13.0 **Term:** Blood pressure increased **Organ System:** Investigations **Source Vocabulary:** MedDRA 13.0 **Term:** Cardiac murmur **Organ System:** Investigations **Source Vocabulary:** MedDRA 13.0 **Term:** Hepatic enzyme increased **Organ System:** Investigations **Source Vocabulary:** MedDRA 13.0 #### Serious Events **Term:** Abscess limb **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 13.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 80 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 82 **Term:** Arteriovenous graft site infection **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 13.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 80 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 82 **Term:** Cellulitis **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 13.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 80 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 82 **Term:** Gastroenteritis **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 13.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 80 **Group ID:** EG001 **Num At Risk:** 82 **Term:** Pneumonia **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 13.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 80 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 82 **Term:** Urinary tract infection **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 13.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 80 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 82 **Term:** Anastomotic haemorrhage **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 13.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 80 **Group ID:** EG001 **Num At Risk:** 82 **Term:** Seroma **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 13.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 80 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 82 **Term:** Vascular graft thrombosis **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 13.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 80 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 82 **Term:** Abdominal pain **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 13.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 80 **Group ID:** EG001 **Num At Risk:** 82 **Term:** Peritoneal adhesions **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 13.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 80 **Group ID:** EG001 **Num At Risk:** 82 **Term:** Small intestinal obstruction **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 13.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 80 **Group ID:** EG001 **Num At Risk:** 82 **Term:** Acute prerenal failure **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 13.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 80 **Group ID:** EG001 **Num At Risk:** 82 **Term:** Renal failure chronic **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 13.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 80 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 82 **Term:** Deep vein thrombosis **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 13.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 80 **Group ID:** EG001 **Num At Risk:** 82 **Term:** Hypotension **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 13.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 80 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 82 **Term:** Anaphylactic reaction **Organ System:** Immune system disorders **Source Vocabulary:** MedDRA 13.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 80 **Group ID:** EG001 **Num At Risk:** 82 **Term:** Hyperkalaemia **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 13.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 80 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 82 **Term:** Lung neoplasm **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 13.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 80 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 82 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 80 **Group ID:** BG001 **Value:** 82 **Group ID:** BG002 **Value:** 162 **Units:** Participants ### Group **ID:** BG000 **Title:** Ferumoxytol **Description:** Participants received an IV injection of ferumoxytol (510 mg, 17 mL) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 g. ### Group **ID:** BG001 **Title:** Iron Sucrose **Description:** Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g. Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g. ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 15.00 **Value:** 61.9 #### Measurement **Group ID:** BG001 **Spread:** 15.16 **Value:** 63.3 #### Measurement **Group ID:** BG002 **Spread:** 15.05 **Value:** 62.6 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 41 #### Measurement **Group ID:** BG001 **Value:** 39 #### Measurement **Group ID:** BG002 **Value:** 80 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 39 #### Measurement **Group ID:** BG001 **Value:** 43 #### Measurement **Group ID:** BG002 **Value:** 82 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 34 #### Measurement **Group ID:** BG001 **Value:** 36 #### Measurement **Group ID:** BG002 **Value:** 70 **Category Title:** Hemodialysis #### Measurement **Group ID:** BG000 **Value:** 46 #### Measurement **Group ID:** BG001 **Value:** 46 #### Measurement **Group ID:** BG002 **Value:** 92 **Category Title:** Nondialysis **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Dialysis Status **Unit of Measure:** Participants **Population Description:** Intent-to-Treat (ITT) Population: Any randomized participant who had any exposure to study drug (IV ferumoxytol or IV iron sucrose). ## Results Section - More Information Module ### Certain Agreement **Other Details:** If there is no multi-site publication within 18 months after the Study has been completed or terminated at all Study sites, and all data has been received by Sponsor, the Site and SMO shall have the right to publish its results from the Study for non-commercial purposes, if submitted to Sponsor for review 60 days prior to submission of publication. Publication must remove all confidential information and may be delayed by up to 180 days to allow Sponsor to protect its interests. **Restriction Type:** OTHER **Restrictive Agreement:** True ### Point of Contact **Email:** [email protected] **Organization:** AMAG Pharmaceuticals, Inc. **Title:** Medical Information ## Results Section - Outcome Measures Module ### Outcome Measure 1 #### Analysis **CI Lower Limit:** -0.21 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.41 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** The 95% CI for hemoglobin change from Baseline (Day 1) was from an ANOVA model and adjusted for baseline hemoglobin level and hemodialysis status. **Group Description:** With LOCF Imputation: The p-value and two-sided 95% confidence interval (CI) for the treatment difference in mean change in hemoglobin from Baseline (Day 1) to Week 5 were generated based on an analysis of variance (ANOVA) model adjusted for baseline hemoglobin level and hemodialysis status. **Non-Inferiority Comment:** Non-inferiority was concluded if the lower bound of the 95% CI was ≥-0.5 g/dL and superiority if the lower bound was ≥0 g/dL. **Non-Inferiority Type:** NON_INFERIORITY **Other Analysis Description:** **P-Value:** 0.515 **P-Value Comment:** The p-value for hemoglobin change from Baseline (Day 1) was adjusted for baseline hemoglobin level and hemodialysis status. **Parameter Type:** Treatment Difference **Parameter Value:** 0.10 **Statistical Comment:** **Statistical Method:** ANOVA **Tested Non-Inferiority:** #### Analysis **CI Lower Limit:** -0.23 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.41 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** The 95% CI for hemoglobin change from Baseline (Day 1) was from an ANOVA model and adjusted for baseline hemoglobin level and hemodialysis status. **Group Description:** Without Imputation (Sensitivity Analysis): The p-value and two-sided 95% CI for the treatment difference in mean change in hemoglobin from Baseline (Day 1) to Week 5 were generated based on an ANOVA model adjusted for baseline hemoglobin level and hemodialysis status. **Non-Inferiority Comment:** Non-inferiority was concluded if the lower bound of the 95% CI was ≥-0.5 g/dL and superiority if the lower bound was ≥0 g/dL. **Non-Inferiority Type:** NON_INFERIORITY **Other Analysis Description:** **P-Value:** 0.587 **P-Value Comment:** The p-value for hemoglobin change from Baseline (Day 1) was adjusted for baseline hemoglobin level and hemodialysis status. **Parameter Type:** Treatment Difference **Parameter Value:** 0.09 **Statistical Comment:** **Statistical Method:** ANOVA **Tested Non-Inferiority:** ### Outcome Measure 2 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.14 - **Upper Limit:** - **Value:** 0.84 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.14 - **Upper Limit:** - **Value:** 0.74 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.15 - **Upper Limit:** - **Value:** 0.89 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.15 - **Upper Limit:** - **Value:** 0.80 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 20 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 11 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 32 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 20 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 37 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 31 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 40 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 34 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** The change in hemoglobin from Baseline (Day 1) to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline) The least squares mean, with standard error, is reported as g/deciliter (dL). Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug). The screening hemoglobin value was used for any participants with missing Baseline (Day 1) hemoglobin. Analysis used last observed carried forward (LOCF) imputation methods for missing values for the ITT population. Sensitivity analyses were performed without imputation for missing data and with the Markov chain Monte Carlo method. **Dispersion Type:** Standard Error **Parameter Type:** LEAST_SQUARES_MEAN **Population Description:** ITT Population: Any randomized participant who had any exposure to study drug (IV ferumoxytol or IV iron sucrose). **Reporting Status:** POSTED **Time Frame:** Baseline (Day 1), Week 5 **Title:** Mean Change In Hemoglobin From Baseline (Day 1) To Week 5 **Type:** PRIMARY **Unit of Measure:** g/dL ##### Group **Description:** Participants received an IV injection of ferumoxytol (510 mg, 17 mL) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 g. **ID:** OG000 **Title:** Ferumoxytol ##### Group **Description:** Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g. Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g. **ID:** OG001 **Title:** Iron Sucrose #### Outcome Measure 2 **Description:** The percentage of participants who achieved a ≥1.0 g/dL increase in hemoglobin at any time from Baseline (Day 1) up to Week 5 by treatment group is presented by study visit. Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug). **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** ITT Population: Any randomized participant who had any exposure to study drug (IV ferumoxytol or IV iron sucrose). **Reporting Status:** POSTED **Time Frame:** Baseline (Day 1) and up to Week 5 **Title:** Percentage Of Participants With An Increase In Hemoglobin ≥1.0 g/dL From Day 1 (Baseline) To Week 5 **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** Participants received an IV injection of ferumoxytol (510 mg, 17 mL) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 g. **ID:** OG000 **Title:** Ferumoxytol ##### Group **Description:** Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g. Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g. **ID:** OG001 **Title:** Iron Sucrose ### Participant Flow Module #### Group **Description:** Participants received an intravenous (IV) injection of ferumoxytol (510 milligrams \[mg\], 17 milliliters \[mL\]) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 grams (g). **ID:** FG000 **Title:** Ferumoxytol #### Group **Description:** Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g. Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g. **ID:** FG001 **Title:** Iron Sucrose #### Period **Title:** Overall Study ##### Withdraw **Type:** Adverse Event ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 4 ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 2 ##### Withdraw **Type:** Other-Protocol Violation ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 1 ##### Withdraw **Type:** Other-Surgery ###### Reason **Group ID:** FG000 **Number of Subjects:** 0 ###### Reason **Group ID:** FG001 **Number of Subjects:** 2 ##### Withdraw **Type:** Other-Missed Week 5 Visit ###### Reason **Group ID:** FG000 **Number of Subjects:** 2 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 80 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 82 ##### Milestone **Type:** Received at Least 1 Dose of Study Drug ###### Achievement **Group ID:** FG000 **Number of Subjects:** 80 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 81 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 75 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 73 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 5 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 9 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT02395679 **Acronym:** MesoCancerVa **Brief Title:** Dendritic Cells Loaded With Allogeneous Cell Lysate in Mesothelioma Patients **Official Title:** A Phase I Study on Dendritic Cells Loaded With Allogeneous Cell Lysate in Patients With Mesothelioma as Maintenance Treatment After Chemotherapy #### Organization Study ID Info **ID:** NL44330.000.14 #### Organization **Class:** OTHER **Full Name:** Erasmus Medical Center ### Status Module #### Completion Date **Date:** 2016-12 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2015-03-23 **Type:** ESTIMATED **Last Update Submit Date:** 2015-03-17 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2015-12 **Type:** ESTIMATED #### Start Date **Date:** 2015-01 **Status Verified Date:** 2015-03 #### Study First Post Date **Date:** 2015-03-23 **Type:** ESTIMATED **Study First Submit Date:** 2015-01-30 **Study First Submit QC Date:** 2015-03-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Erasmus Medical Center #### Responsible Party **Investigator Affiliation:** Erasmus Medical Center **Investigator Full Name:** joost hegmans **Investigator Title:** Head production **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** Malignant mesothelioma is an aggressive pleural disease, related to asbestos exposure. At present, cytotoxic chemotherapy is the only evidence based treatment for the disease, but efficacy is limited. The investigators have shown both in a murine model, as for the first time in patients, that dendritic cell-based immunotherapy induces tumor specific T-cell responses. However the quality and quantity of the autologous tumor cell lysate to load the dendritic cells was a major impediment for these trials. The investigators have now developed a clinical grade allogeneic tumor cell lysate which can be used to load dendritic cells of patients. **Detailed Description:** Objective: To investigate the safety of an allogeneic tumor cell lysate (PheraLys) loaded onto autologous dendritic cells (MesoCancerVac) in patients with malignant mesothelioma (MM). Study design: A phase I study with a classical 3\*3 design. Study population: Adult patients with malignant mesothelioma who were treated with chemotherapy as standard treatment. Intervention: After chemotherapy, a leukapheresis is performed of which the monocytes are used for differentiation to DCs using specific cytokines. Pulsed autologous DCs (MesoCancerVac) are re-injected 3 times every two weeks. After the third injection with MesoCancerVac, revaccinations to boost the immune system are given after 3 and 6 months. Main study parameters/endpoints: The aim of this phase I protocol is to study the toxicity and safety of MesoCancerVac (DC-based immunotherapy) in MM patients. Toxicities will be scored according to common toxicity criteria version 4.0. The following toxicities occurring during 8 weeks after the first vaccination, will be considered as dose-limiting toxicities (DLTs). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients have to undergo extra outdoor visits for this study (10-20) and extra invasive procedures especially for this trial, like a catheter in a blood vessel. These are invasive procedure but risks are limited. This iv entrance is necessary every time, for the leukopheresis, for blood samples and for the injection of the dendritic cells. A leucopheresis is a standard procedure and will be performed according to guidelines. There is a limited risk for transient thrombocytopenia and leukopenia. The administration of autologous cells, that have been loaded with allogeneic human materials, is a potential risk and that is the subject of the study. Because not the lysate itself is administered to the patients but only when it is processed by the dendritic cells of the patient the investigators expect these risks to be limited. ### Conditions Module **Conditions:** - Mesothelioma **Keywords:** - Dendritic cell-based immunotherapy ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 9 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Autologous dendritic cells loaded with a mixture of 5 allogenic mesothelioma tumor cell lysates 3 to 5 vaccinations with 10x10e6, 25x10e6 or 50x10e6 loaded dendritic cells i.d. and i.v. administration every two weeks **Intervention Names:** - Biological: MesoCancerVac **Label:** MesoCancerVac **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - MesoCancerVac **Description:** A leukapheresis is performed of which the monocytes are used for differentiation to DCs using specific cytokines. Pulsed autologous DCs (MesoCancerVac) are re-injected 3 times every two weeks. After the third injection with MesoCancerVac, revaccinations to boost the immune system are given after 3 and 6 months. **Name:** MesoCancerVac **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Tolerability of MesoCancerVac is monitored by performing clinical laboratory tests (autoimmune responses), assessments of vital signs, full clinical examination, occurrence of adverse events. **Measure:** The primary objective is to establish a tolerable dose of MesoCancerVac in patients with malignant mesothelioma **Time Frame:** 4 weeks after third administration #### Secondary Outcomes **Description:** Immune response is evaluated by measuring : The functionality of T-cells by laboratory testing (cytotoxicity and interferon-gamma secretion) **Measure:** The secondary objective is the evaluation of an immune response after MesoCancerVac **Time Frame:** 2 months after third administration ### Eligibility Module **Eligibility Criteria:** Inclusion criteria In order to be eligible to participate in this study, a subject must meet all of the following criteria: * Patients with histological or cytological confirmed diagnosed ,malignant mesothelioma, who are non progressive after at least 4 cycles of cisplatin and pemetrexed containing chemotherapy (as determined by CT scanning). * Measurable disease on CT scanning in two dimensions by a radiologic imaging study. * Patients must be at least 18 years old and must be able to give written informed consent. * Patients must be ambulatory (WHO performance status 0,1, or 2 \[Appendix E\&F\]) The expected survival must be at least 3 months. * Patients must have normal organ function and adequate bone marrow reserve: absolute neutrophil count \> 1.0 x 10e9/l, platelet count \> 100 x 10e9/l, and Hb \> 6.0 mmol/l.(as determined during screening * Positive delayed type hypersensitivity skin test (induration \> 2mm after 48 hrs) against at least one positive control antigen tetanus toxoid. * Ability to return to the Erasmus Medical Center for adequate follow-up as required by this protocol. * Written informed consent according to good clinical practice * Planned start date of vaccination between 5 weeks after the last dosage of chemotherapy Exclusion criteria A potential subject who meets any of the following criteria will be excluded from participation in this study: * Medical or psychological impediment to probable compliance with the protocol. * Current use of steroids (or other immunosuppressive agents). Patients must have had 6 weeks of discontinuation and must stop of any such treatment during the time of the study. Prophylactic usage of dexamethasone during chemotherapy is excluded from that 6 weeks interval * Prior malignancy except adequately treated basal cell or squamous cell skin cancer, superficial or in-situ cancer of the bladder or other cancer for which the patient has been disease-free for five years. * Serious concomitant disease, or active infections. * History of autoimmune disease or organ allografts, or with active acute or chronic infection, including HIV and viral hepatitis. * Serious intercurrent chronic or acute illness such as pulmonary (asthma or COPD) or cardiac (NYHA class III or IV) or hepatic disease or other illness considered by the study coordinator to constitute an unwarranted high risk for investigational DC treatment. * Known allergy to shell fish (may contain KLH). * Pregnant or lactating women. * Inadequate peripheral vein access to perform leukapheresis * Concomitant participation in another clinical trial * An organic brain syndrome or other significant psychiatric abnormality which would comprise the ability to give informed consent, and preclude participation in the full protocol and follow-up. * Absence of assurance of compliance with the protocol. Lack of availability for follow-up assessment. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Joachim G. Aerts, MD PhD **Phone:** +31 10 704 3697 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Cor H. van der Leest, MD PhD **Phone:** +31 10 704 3697 **Role:** CONTACT #### Locations **Location 1:** **City:** Rotterdam **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Cor P. van der Leest, PhD - **Phone:** +31 10 703 4862 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Robin Cornelissen, PhD - **Phone:** +31 10 703 4862 - **Role:** CONTACT **Country:** Netherlands **Facility:** Erasmus MC, Dept. of Pulmonary Medicine **State:** Zuid-Holland **Status:** RECRUITING **Zip:** 3015GD #### Overall Officials **Official 1:** **Affiliation:** Erasmus Medical Center Cancer Institure **Name:** Henk C Hoogsteden, MD PhD **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Hegmans JP, Veltman JD, Lambers ME, de Vries IJ, Figdor CG, Hendriks RW, Hoogsteden HC, Lambrecht BN, Aerts JG. Consolidative dendritic cell-based immunotherapy elicits cytotoxicity against malignant mesothelioma. Am J Respir Crit Care Med. 2010 Jun 15;181(12):1383-90. doi: 10.1164/rccm.200909-1465OC. Epub 2010 Feb 18. **PMID:** 20167848 **Citation:** Cornelissen R, Heuvers ME, Maat AP, Hendriks RW, Hoogsteden HC, Aerts JG, Hegmans JP. New roads open up for implementing immunotherapy in mesothelioma. Clin Dev Immunol. 2012;2012:927240. doi: 10.1155/2012/927240. Epub 2012 Jun 24. **PMID:** 22778767 **Citation:** Cornelissen R, Lievense LA, Heuvers ME, Maat AP, Hendriks RW, Hoogsteden HC, Hegmans JP, Aerts JG. Dendritic cell-based immunotherapy in mesothelioma. Immunotherapy. 2012 Oct;4(10):1011-22. doi: 10.2217/imt.12.108. **PMID:** 23148753 **Citation:** Hegmans JP, Hemmes A, Aerts JG, Hoogsteden HC, Lambrecht BN. Immunotherapy of murine malignant mesothelioma using tumor lysate-pulsed dendritic cells. Am J Respir Crit Care Med. 2005 May 15;171(10):1168-77. doi: 10.1164/rccm.200501-057OC. Epub 2005 Mar 11. **PMID:** 15764728 **Citation:** Vroman H, Balzaretti G, Belderbos RA, Klarenbeek PL, van Nimwegen M, Bezemer K, Cornelissen R, Niewold ITG, van Schaik BD, van Kampen AH, Aerts JGJV, de Vries N, Hendriks RW. T cell receptor repertoire characteristics both before and following immunotherapy correlate with clinical response in mesothelioma. J Immunother Cancer. 2020 Mar;8(1):e000251. doi: 10.1136/jitc-2019-000251. Erratum In: J Immunother Cancer. 2020 Jun;8(1): **PMID:** 32234848 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000000236 - Term: Adenoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000018301 - Term: Neoplasms, Mesothelial - ID: D000008175 - Term: Lung Neoplasms - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000010997 - Term: Pleural Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11634 - Name: Mesothelioma - Relevance: HIGH - As Found: Mesothelioma - ID: M2537 - Name: Mesothelioma, Malignant - Relevance: HIGH - As Found: Mesothelioma - ID: M3591 - Name: Adenoma - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M20445 - Name: Neoplasms, Mesothelial - Relevance: LOW - As Found: Unknown - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M13887 - Name: Pleural Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: T3584 - Name: Malignant Mesothelioma - Relevance: HIGH - As Found: Mesothelioma ### Condition Browse Module - Meshes - ID: D000008654 - Term: Mesothelioma - ID: D000086002 - Term: Mesothelioma, Malignant ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01502579 **Brief Title:** An Observational Study of IgA Nephropathy: Pathological Variants and Clinical Data **Official Title:** An Observational Study of the Relationship Between Pathological Variants and Clinical Data at Presentation and Follow-up in IgA Nephropathy #### Organization Study ID Info **ID:** GGH201106 #### Organization **Class:** OTHER **Full Name:** Guangdong Provincial People's Hospital ### Status Module #### Completion Date **Date:** 2013-08 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2013-08-28 **Type:** ESTIMATED **Last Update Submit Date:** 2013-08-27 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2013-08 **Type:** ACTUAL #### Start Date **Date:** 2011-09 **Status Verified Date:** 2013-08 #### Study First Post Date **Date:** 2011-12-30 **Type:** ESTIMATED **Study First Submit Date:** 2011-12-29 **Study First Submit QC Date:** 2011-12-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Guangdong Provincial People's Hospital #### Responsible Party **Investigator Affiliation:** Guangdong Provincial People's Hospital **Investigator Full Name:** Wei Shi **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The pathological variants of IgA nephropathy identified by the Oxford classification may be related to the clinical data at presentation and follow-up, including proteinuria and renal function. This study is aimed to identify the potential relationship between pathological variants and clinical data in IgA nephropathy. ### Conditions Module **Conditions:** - IgA Nephropathy **Keywords:** - IgA nephropathy ### Design Module #### Design Info **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 603 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Measure:** glomerular filtration rate decline or end-stage renal disease or doubling of serum creatinine **Time Frame:** after the biopsy ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * biopsy-proven IgA nephropathy; Exclusion Criteria: **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The population from which the cohort will be selected is these who have received renal biopsy in Guangdong General Hospital ### Contacts Locations Module #### Locations **Location 1:** **City:** Guangzhou **Country:** China **Facility:** Guangdong General Hospital **State:** Guangdong **Zip:** 510080 #### Overall Officials **Official 1:** **Affiliation:** Guangdong Provincial People's Hospital **Name:** Wei Shi, MD,PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000005921 - Term: Glomerulonephritis - ID: D000009393 - Term: Nephritis - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: HIGH - As Found: Nephropathy - ID: M9032 - Name: Glomerulonephritis, IGA - Relevance: HIGH - As Found: IgA Nephropathy - ID: M9031 - Name: Glomerulonephritis - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M12338 - Name: Nephritis - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T3008 - Name: IgA Nephropathy - Relevance: HIGH - As Found: IgA Nephropathy - ID: T2525 - Name: Glomerulonephritis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007674 - Term: Kidney Diseases - ID: D000005922 - Term: Glomerulonephritis, IGA ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M10118 - Name: Immunoglobulin A - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05418179 **Brief Title:** Effect of Probiotic Supplementation on Fecal Microbiota, Nutritional Status, Metabolic and Inflammatory Parameters in Patients With Type 2 Diabetes Mellitus **Official Title:** Effect of Probiotic Supplementation on Fecal Microbiota, Nutritional Status, Metabolic and Inflammatory Parameters in Patients With Type 2 Diabetes Mellitus: Study Protocol for a Triple-blind Controlled Randomized Clinical Trial #### Organization Study ID Info **ID:** UFSC_2021 #### Organization **Class:** OTHER **Full Name:** Universidade Federal de Santa Catarina ### Status Module #### Completion Date **Date:** 2023-12-24 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-03-28 **Type:** ACTUAL **Last Update Submit Date:** 2023-03-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2023-12-20 **Type:** ESTIMATED #### Start Date **Date:** 2021-12-01 **Type:** ACTUAL **Status Verified Date:** 2023-03 #### Study First Post Date **Date:** 2022-06-14 **Type:** ACTUAL **Study First Submit Date:** 2022-06-05 **Study First Submit QC Date:** 2022-06-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universidade Federal de Santa Catarina #### Responsible Party **Investigator Affiliation:** Universidade Federal de Santa Catarina **Investigator Full Name:** Erasmo Benicio Santos de Moraes Trindade **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to evaluate the effect of probiotic supplementation on fecal microbiota, nutritional status, metabolic and inflammatory parameters in patients with type 2 diabetes mellitus. Study hypothesis: Supplementation of multispecies probiotic (Bifidobacterium Lactis, B. brebe, B. longum, Lactobacillus gasseri, L. casei, L. rhamnosus) during 12 weeks improves the the fecal microbiota composition and promotes reduction of plasma/serum levels of acute phase proteins, cytokines, metabolic and anthropometric parameters in individuals with type 2 diabetes mellitus. **Detailed Description:** The purpose of this study is to evaluate the effect of multispecies probiotic supplementation (specifically designed for the present study) on fecal microbiota, nutritional status, metabolic and inflammatory parameters in patients with type 2 diabetes mellitus (T2DM). Adult individuals (35 to 75 years old) of both sexes with T2DM (diagnosed at least 1 year ago), body mass index from 25.00 kg/m² to 39.99 kg/m², glycated hemoglobin ≤ 9.0% and using metformin will be invited to participate in this randomized, placebo-controlled, triple-blind study. The participants will be randomized into two groups: G1 - probiotic group and G2 - control group (placebo). The study will consist of two experimental time points: M0 - baseline and start of supplementation; M1 - after 12 weeks of the first outpatient visit and start of supplementation. In the two experimental moments, individual fecal samples will be obtained for analysis of the fecal microbiota; The metabolic parameters will be assessed by determination of circulating levels of SCFA, FFA, insulin, fasting glucose and glycated hemoglobin, HOMA-IR; Total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides; the inflammatory response will be assessed by determination of plasma indicadors (LPS, Adiponectina, IL-10, IL-1, IL-6, TNF- α, Leptina, Resistina) ; besides the evaluation of indicators of nutritional status (bone densitometry with body composition and anthropometric measurements). The primary endpoint will be the fecal microbiota composition, SCFA concentrations and the inflammatory parameters. ### Conditions Module **Conditions:** - Type 2 Diabetes Mellitus ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** Study participants and researchers were masked over consumption and distribution of supplementation, respectively. Laboratory technicians who performed the blood collection were also masked as to the distribution of supplementation. Supplements and placebo were pre-packaged by the supplier in opaque and closed sachets with randomization codes, being identical in physical appearance, taste and color. Supplement identification codes were only disclosed by the supplier after statistical analysis of study data. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Maltodextrin (1 capsule/day) **Intervention Names:** - Dietary Supplement: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** Probiotic (Bifidobacterium animalis subsp. Lactis, Bifidobacterium breve, Bifidobacterium longum, Lactobacillus gasseri, Lactobacillus casei, Lactobacillus rhamnosus) - 1 capsule/day **Intervention Names:** - Dietary Supplement: Probiotic **Label:** Probiotic **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Probiotic **Description:** Probiotic (Bifidobacterium animalis subsp. Lactis, Bifidobacterium breve, Bifidobacterium longum, Lactobacillus gasseri, Lactobacillus casei, Lactobacillus rhamnosus) - 1 capsule/day **Name:** Probiotic **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Maltodextrin (1 capsule/day) **Name:** Placebo **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** analysis method: 16s rRNA sequencing and bioinformatics analysis. Reported measure: taxonomic profiles of the microbial populations (operational taxonomic units / OTUs) **Measure:** Fecal Microbiota **Time Frame:** 12 weeks compared to baseline **Description:** Acetate, propionate, isobutyrate, butyrate and isovalerate (μmol/L) **Measure:** SCFA **Time Frame:** 12 weeks compared to baseline **Description:** Plasma LPS, adiponectin, leptin, resistin, IL-1, IL-6, IL-8, IL-10 and TNF-alpha concentrations (pg/mL) **Measure:** Inflammatory parameters **Time Frame:** 12 weeks compared to baseline #### Secondary Outcomes **Description:** μUI/mL **Measure:** Fasting insulin **Time Frame:** 12 weeks compared to baseline **Description:** mg/dL **Measure:** fasting blood glucose **Time Frame:** 12 weeks compared to baseline **Description:** HOMA-IR = \[fasting blood glucose (mmol) x fasting insulin (UI/ml)\] ÷ 22,5 **Measure:** HOMA-IR **Time Frame:** 12 weeks compared to baseline **Description:** percentage (%) **Measure:** Glycated hemoglobin **Time Frame:** 12 weeks compared to baseline **Description:** µmol/L **Measure:** Free Fat Acids **Time Frame:** 12 weeks compared to baseline **Description:** mg/dL. **Measure:** Triglycerides **Time Frame:** 12 weeks compared to baseline **Description:** mg/dL **Measure:** Total cholesterol **Time Frame:** 12 weeks compared to baseline **Description:** (Friedewald equation) LDL-c = total colesterol - HDL-c - Triglicerídeos/5 Reported measure: mg/dL **Measure:** LDL-c **Time Frame:** 12 weeks compared to baseline **Description:** mg/dL **Measure:** HDL-c **Time Frame:** 12 weeks compared to baseline **Description:** Dual X-ray Absorptiometry (DXA). Reported measure: T-score and Z-score **Measure:** Bone densitometry **Time Frame:** 12 weeks compared to baseline **Description:** kilograms **Measure:** Body weight (kg) **Time Frame:** 12 weeks compared to baseline **Description:** centimeters (cm) **Measure:** Waist circumference (cm) **Time Frame:** 12 weeks compared to baseline **Description:** In metric units: BMI (kg/m²) = weight (kg) ÷ height² (meters). Reported measure: kg/m². **Measure:** Body mass index (BMI) **Time Frame:** 12 weeks compared to baseline **Description:** Dual X-ray Absorptiometry (DXA). Reported measure: Total Body Fat Percentage (%BF) **Measure:** Total Body Fat Percentage (%BF) **Time Frame:** 12 weeks compared to baseline **Description:** Dual X-ray Absorptiometry (DXA) - Fat Mass Index (FMI) - the total amount of fat (in kilograms) relative to the height (in meters²) **Measure:** Fat Mass Index (FMI) **Time Frame:** 12 weeks compared to baseline **Description:** Dual X-ray Absorptiometry (DXA) - Total Body lean mass Percentage (%): The percent of the body that is not composed of fat. **Measure:** Total Body lean mass Percentage (%) **Time Frame:** 12 weeks compared to baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age from 35 to 75 years old; * Individuals diagnosed with type 2 diabetes mellitus (at least 1 year ago); * Body mass index from 25.00 kg/m² to 39.99 kg/m²; * Glycated hemoglobin ≤ 9.0% ; * Using metformin, combined or not with other antidiabetic drugs Exclusion Criteria: * Previous bowel diseases (inflammatory bowel disease and irritable bowel syndrome); or previous gastrointestinal surgery (eg, colectomy, gastrectomy) * Intolerances and ∕ or food allergies with a previous medical diagnosis (eg lactose intolerance or celiac disease); * Glomerular filtration rate \<30 ml/min/1.73m²; inflammatory diseases and immunodeficiencies; * Diagnosis of autonomic neuropathy with gastrointestinal involvement such as: diabetic gastroparesis, diabetic enteropathy (diarrhea) or colonic hypomotility (constipation); * Hospital admission and/or use of anti-inflammatory drugs (non-hormonal and corticosteroids) up to 1 month before the study; and ∕or use of antibiotics up to 3 months before the study; * Regular use of laxatives, opioid narcotic analgesics or appetite suppressants; * Current or previous use (up to 1 month) of prebiotics, probiotics, symbiotics or products enriched with these food supplements; * Intolerance to prebiotics, probiotics or symbiotics; * Pregnant or breastfeeding; * Follow-up of a diet, guided by a nutritionist, for weight loss or gain up to 1 month before the study or current follow-up of unusual diets (eg vegetarian, macrobiotic, paleolithic); * Alcohol consumption (\> 1 drink/day or 14g of alcohol for women; \>2 drinks/day or 28 grams of alcohol for men); use of illicit drugs and smokers; * Change of lipid-lowering and/or antidiabetic drugs in the last 3 months **Maximum Age:** 75 Years **Minimum Age:** 35 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Erasmo Trindade, PhD **Phone:** +55 48 3721-3489 **Role:** CONTACT #### Locations **Location 1:** **City:** Florianópolis **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Erasmo BSM Trindade, PhD - **Phone:** +55 48 3721-3489 - **Role:** CONTACT **Country:** Brazil **Facility:** Polydoro Ernani de São Thiago University Hospital **State:** Santa Catarina **Status:** RECRUITING **Zip:** 88036-800 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes Mellitus - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: HIGH - As Found: Type 2 Diabetes Mellitus - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003924 - Term: Diabetes Mellitus, Type 2 ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M16201 - Name: Sulfalene - Relevance: LOW - As Found: Unknown - ID: T367 - Name: Bifidobacterium - Relevance: LOW - As Found: Unknown - ID: T355 - Name: Acidophilus - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04201379 **Brief Title:** Determines of Quality of Life in Patients **Official Title:** Nonspecific Neck Patients's Quality of Life and Their Predictors #### Organization Study ID Info **ID:** KA19/406 #### Organization **Class:** OTHER **Full Name:** Baskent University ### Status Module #### Completion Date **Date:** 2020-04-25 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2020-04-30 **Type:** ACTUAL **Last Update Submit Date:** 2020-04-29 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-03-25 **Type:** ACTUAL #### Start Date **Date:** 2019-09-30 **Type:** ACTUAL **Status Verified Date:** 2019-01 #### Study First Post Date **Date:** 2019-12-17 **Type:** ACTUAL **Study First Submit Date:** 2019-11-28 **Study First Submit QC Date:** 2019-12-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Baskent University #### Responsible Party **Investigator Affiliation:** Baskent University **Investigator Full Name:** Ayça Aytar TIĞLI **Investigator Title:** Physical therapist Phd **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Pain, muscle spasm, loss of muscle strength and impaired posture adversely affect the daily life activities and quality of life of neck pain patients.However, the quality of life; It is a multifaceted concept that includes not only the age, sex, marital status, educational status and duration of pain, but also the number of children, BMI, depression, sleep quality, pain-related inadequacy and fatigue. Therefore, considering all these; quality of life; The aim of our study was to determine the factors affecting the quality of life in nonspesific neck patients with the effect that the determinants affecting physical, physical role difficulty, pain, general health, vitality, social function, emotional role difficulty and mental health may be different. **Detailed Description:** The study will include 93 people with a diagnosis neck disease who apply to the physical therapy outpatient clinic. After recorded sociodemographic and clinical characteristics of the individuals, some evaluations will be done only once. The evaluations to be used in the study are as follows: Pain Assesment will be evaluated with McGill Pain Questionnaire, Sleep disorders will be evaluated with Pitsburgh Sleep Quality Index (PSQI), Fatigue level will be assessed by the Fatigue Questionnaire, Beck Depression Inventory (BDI) will be used to determine depression levels. The quality of life of the subjects wiil be evaluate by using the Short Form-36 questionnaire. ### Conditions Module **Conditions:** - Chronic Neck Pain **Keywords:** - chronic - neckpain ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 93 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** servical disk hernisi servical spondilosis servical problems **Intervention Names:** - Other: quality of life assesment **Label:** neck pain patients #### Arm Group 2 **Description:** healthy people **Intervention Names:** - Other: quality of life assesment **Label:** control ### Interventions #### Intervention 1 **Arm Group Labels:** - control - neck pain patients **Description:** The sociodemographic and clinical characteristics of the individuals who meet the study criteria will be recorded. Evaluations of the participants will be done only once **Name:** quality of life assesment **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** to reported determining factors affecting their quality of life Short form-SF36 .All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. Aggregate scores are compiled as a percentage of the total points possible, using the RAND scoring table (STEP I chart). The scores from those questions that address each specific area of functional health status (STEP II chart) are then averaged together, for a final score within each of the 8 dimensions measured. (eg pain, physical functioning etc.) **Measure:** DETERMINING FACTORS AFFECTING THE QUALITY OF LIFE **Time Frame:** 27 february 2020 **Description:** MCMcGill Pain Questionnaire will be used to report pain.The McGill Pain Questionnaire (MPQ) is a three-part pain assessment tool that measures several dimensions of the patient's pain experience. The first part consists of an anatomic drawing of the human form on which the patient marks where his or her pain is located. The second part of the MPQ is a VDS that allows the patient to record the intensity level of his or her current pain experience. The third part of the MPQ is a pain verbal descriptor inventory consisting of 72 descriptive adjectives. The patient is asked to review this list of pain descriptors and circle the ones that serve to best describe his or her current pain experience. Each part or dimension of the MPQ is individually scored and a cumulative total score is also recorded. **Measure:** IS PAIN DETERMINING THE QUALITY OF LIFE **Time Frame:** 27 february 2020 **Description:** Visual Analog Score for pain, Physicians Global Assessment to measure quality of life.The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme .r pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[100-mm scale\]) **Measure:** IS PAIN INTENSITY DETERMINING THE QUALITY OF LIFE **Time Frame:** 27 february 2020 **Description:** te report the effect of sleep quality Pitsburgh Sleep Quality Index will be used. The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in the older adult. It differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. The client self rates each of these seven areas of sleep. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of "5"or greater indicates a "poor" sleeper **Measure:** IS SLEEP QUALİTY DETERMINING THE QUALITY OF LIFE **Time Frame:** 27 february 2020 **Description:** Fatigue Questionnaire will be used to report fatigue.Scoring using a bimodal response system or a Likert score with weights assigned to each response choice. Likert or bimodal rating scales with 4 response options. For the Likert Scale: better than usual = 0, no more than usual = 1, worse than usual = 2, much worse than usual = 3. For the bimodal scale: better than usual = 0, no more than usual = 0, worse than usual = 1, much worse than usual = 1. Sum all items for a total score. **Measure:** IS FATIGUE DETERMINING THE QUALITY OF LIFE **Time Frame:** 27 february 2020 **Description:** to report depression levels Beck Depression Inventory (BDI) will be used.Each of the four multiple choice answers is assigned a point value from 0 to 3. At the end of the assessment, you add up the total points from the answers throughout the 21 questions. Hıgh scores ındıcate worse depressıon levels **Measure:** IS DEPRESSION DETERMINING THE QUALITY OF LIFE **Time Frame:** 27 february 2020 **Description:** te report the effect of anxıety State-Trait Anxiety Inventory (STAI) will be used.The higher the score, the higher the level of anxiety. **Measure:** IS Anxıety DETERMINING THE QUALITY OF LIFE **Time Frame:** 27 february 2020 **Description:** to report disability levels we will be used The Pain Disability Index.High score indicates high disability **Measure:** Is pain disability DETERMINING THE QUALITY OF LIFE **Time Frame:** 27 february 2020 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1) People 18 years and older Exclusion Criteria: 1. Hospitalized people 2. Newly Operated People 3. People with psychological diagnosis **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** people with a diagnosis of neck disease living in Ankara and who can answer the study questions ### Contacts Locations Module #### Locations **Location 1:** **City:** Ankara **Country:** Turkey **Facility:** Ayça Aytar ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M21485 - Name: Neck Pain - Relevance: HIGH - As Found: Neck Pain - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000019547 - Term: Neck Pain ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03329079 **Brief Title:** Engaging Rural Men With Mobile Technologies for Weight Loss **Official Title:** Engaging Rural Men With Mobile Technologies for Weight Loss: A Randomized Controlled Trial. #### Organization Study ID Info **ID:** 0594-17-EP #### Organization **Class:** OTHER **Full Name:** University of Nebraska ### Status Module #### Completion Date **Date:** 2022-06-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-10-04 **Type:** ACTUAL **Last Update Submit Date:** 2023-10-02 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-06-30 **Type:** ACTUAL #### Results First Post Date **Date:** 2023-10-04 **Type:** ACTUAL **Results First Submit Date:** 2022-10-05 **Results First Submit QC Date:** 2023-10-02 #### Start Date **Date:** 2018-06-06 **Type:** ACTUAL **Status Verified Date:** 2023-10 #### Study First Post Date **Date:** 2017-11-01 **Type:** ACTUAL **Study First Submit Date:** 2017-10-18 **Study First Submit QC Date:** 2017-10-31 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Northeast Nebraska Public Health Department #### Lead Sponsor **Class:** OTHER **Name:** University of Nebraska #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Overweight and obese men in rural Northeast Nebraska are an unrepresented, at-risk group exhibiting rising rates of cardiovascular disease, poor access to preventive care, and a rural milieu that contributes to their sedentary physical activity and unhealthy diet. This study proposes to use a pragmatic randomized controlled trial and community engaged research approaches to 1) determine the feasibility and acceptability of a commercially available, smart phone self-monitoring app (premium-version) plus text-based coaching and daily weighing via Wi-Fi scale intervention for achieving weight loss, 2) determine preliminary efficacy of this intervention group to a comparison group receiving only a self-monitoring app (basic-version) in achieving the outcomes of weight loss (kilogram) and improved dietary and physical activity behaviors (secondary) at 6 months post-baseline, and 3) determine quantitative and qualitative indicators of community capacity to support a contextually relevant weight loss intervention. Eighty men (ages 40-69) with body mass index of 28 or higher, randomly assigned (1:1 ratio) to intervention group or comparison group. Men will complete baseline assessments (weight, % body fat, body mass index height, blood pressure, health history, dietary intake, physical activity frequency/intensity) and receive orientation to the mobile technologies (app features, text messaging, Wi-Fi scale). Men will track their dietary intake, physical activity, and weight on the app for 12 weeks. After the 3-month intervention, post-measure assessments (weight, % body fat, BMI, dietary intake, PA frequency/intensity, technology usability surveys) will be collected at 3 and 6 months post-baseline. At 6 months post-baseline, two groups (n=8 each) of intervention completers will be purposively selected to share their perceptions of the intervention efficacy in an evaluative focus group. A community advisory board comprising local leaders within the men's social network, together with investigators and rural student nurses will guide community outreach efforts for study recruitment, implementation and evaluation. Study findings will be evaluated with the community to inform local dissemination, future intervention revision, and determination of community capacity for support of a larger clinical trial. **Detailed Description:** Obesity is a major public health problem that disproportionately affects rural men and promotes the development of chronic conditions such as diabetes, cardiovascular disease, arthritis, and cancer. This study proposes to evaluate a mobile self-monitoring application (app) with Wi-Fi scale and text messaging intervention (MT+: mobile technology plus) for achieving weight loss in overweight and obese rural men. This proposal aligns with 1) Healthy People 2020's aim to eliminate health disparities by increasing physical activity and reducing obesity in adults; 2) the NIH's strategic plan to prioritize obesity reduction research among underserved rural populations; and, 3) the NINR's strategic focus on technology to promote health. Sixty nine percent of rural men in Nebraska are overweight or obese with increasing prevalence during midlife 40-59 (40%) and older (36%). Rural men are more likely to smoke, be obese, be physically inactive, and have shorter lifespans (2 years) than urban men. Rural men are also more likely to be uninsured/underinsured, less likely to engage in preventive health services, and report overall poorer health than urban men. Despite the burden of obesity, no self-monitoring mobile technology interventions targeting weight loss in rural, U.S. males exist, though the investigators preliminary study demonstrated rural men will use mobile technology for eating and activity self-monitoring. Studies show self-monitoring as one of the most effective behavior-change techniques for weight loss. MT+ provides an accessible means of real-time self-monitoring support for targeting lifestyle behaviors that lead to weight loss. The investigators propose a pragmatic, randomized controlled trial (RCT) to examine the feasibility, acceptability, and preliminary efficacy of a MT+ intervention for weight loss in overweight and obese men in a practical, real-life rural environment. This 6-month pilot RCT includes a 3-month intervention with 6-month post-baseline follow-up. The intervention group (n=40) will receive a 3-month MT+ intervention using a commercially available, premium-version mobile phone app with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale. The comparison group (n=40) will receive the basic-version mobile phone app only (MT). Primary efficacy outcome will be loss of body weight (kg \& % body weight) at 3 and 6 months. Secondary outcomes will be improved diet and increased physical activity (PA). A multi-method formative evaluation of the intervention (student outreach, community advisory board (CAB), community capacity surveys, focus group, community dissemination) will occur across the study. Primary feasibility outcomes will include recruitment/retention rates and community resource development for program sustainment. The multi-modal feedback will help 1) facilitate recruitment of a hard-to-reach population, and 2) inform intervention feasibility and acceptability. These local insights may foster minimized attrition and improve future study outcomes. The specific aims of this study are: Aim #1: Determine the feasibility and acceptability of a MT+ intervention for achieving weight loss in rural overweight and obese men. The aim will specifically address groups by the 1) participation rates including number of men recruited and randomized over a 6 month period. 2) retention rates, 3) feasibility, usability, satisfaction ratings, 4) adherence record of logging by men in the intervention group, and 5) evaluative focus group feedback. Aim #2: Determine preliminary efficacy of a MT+ intervention to a comparison group receiving only a basic self-monitoring app (MT) in achieving 1) weight loss (primary), and 2) improved dietary and PA behavior (secondary) at 6 months post-baseline in rural men. Aim #3: Determine quantitative and qualitative indicators of community capacity (resource mobilization, learning opportunities-skills development, partnership linkages, participatory decision-making, leadership) to support a relevant weight loss intervention for rural men. Through a collaborative process guided by Community-Engaged Research (CEnR) approaches with a community-academic partnership involving UNMC students, community leaders, the investigators plan to create and disseminate local knowledge about obesity in rural men. Specifically, the investigators plan to 1) document the feasibility, acceptability, and preliminary efficacy of a weight loss intervention among rural men, a current gap in the NIH health disparities portfolio, 2) engage rural communities through student-informed outreach approaches and CAB partnership linkages to improve the efficacy of weight loss interventions for rural men, and 3) strengthen the research environment of the University of Nebraska Medical Center (UNMC) institution through providing opportunities for undergraduate and graduate students to conduct CEnR. ### Conditions Module **Conditions:** - Weight Loss **Keywords:** - rural - men - community-based participatory research - weight loss - mobile applications - text messaging ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Masking Description:** The assessor will know which group assignment the subject has been given as is required for him to download the appropriate app and provide training on the technology to the subject. **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 80 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Experimental arm will receive a 3-month MT+ intervention using the premium mobile phone app version with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale. **Intervention Names:** - Behavioral: Mobile Technology Plus **Label:** Mobile Technology Plus (MT+) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Comparison group will receive the basic version of the mobile phone app only. **Intervention Names:** - Behavioral: Mobile Technology **Label:** Mobile Technology (MT) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Mobile Technology Plus (MT+) **Description:** The intervention group MT+ will receive the premium-version mobile phone app with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale. **Name:** Mobile Technology Plus **Other Names:** - MT+ **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Mobile Technology (MT) **Description:** The comparison group MT will receive the basic-version mobile phone app only to self monitor eating, activity, and weight. **Name:** Mobile Technology **Other Names:** - MT **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Weight in kilograms (as measured on a Tanita brand digital scale, TBF-215 Tanita Corporation of America) **Measure:** Mean Change in Weight by Randomized Group **Time Frame:** Observed means from baseline weight and at 6 months #### Secondary Outcomes **Description:** daily fruit and vegetable servings (Brief Risk Factor Surveillance Survey written questionnaire- Fruit and vegetable dietary intake module (Reported total number of fruit and vegetable serving sizes per 24 hour period) **Measure:** Point Estimate and Variability of Outcome Measure for Fruit and Vegetable Intake **Time Frame:** Observed means from baseline fruit and vegetable intake at 6 months **Description:** sugar-sweetened total beverage energy intake (Sugar Sweetened beverage intake questionnaire (BEV-Q15) Reported total number of fluid ounces consumed per 24 hour period) **Measure:** Point Estimate and Variability of Outcome Measure for Beverage Intake Quality **Time Frame:** Observed means from baseline beverage intake and at 6 months **Description:** total steps taken in 24 hour period (Automated app report of total steps measured via gyroscope on smart phone- total step count range 0-10,000 steps (higher step value represents desired outcome of 10,000 steps per day) **Measure:** Point Estimate and Variability of Outcome Measure for Physical Activity **Time Frame:** Observed means from baseline overall physical activity and at 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Man age 40-69 * Reside in Northeast Nebraska * BMI of 28 (kg/m2) or higher (BMI greater than 50 with clinician clearance, maximum weight 396 pounds) * Smart phone owner with enabled text messaging * Have an email account * Answer "no" to all questions on the PAR-Q 17 health history assessment or are willing to get physician evaluation prior to enrolling * Willing to share self-monitoring logs of eating, activity, and weight with investigative team. Exclusion Criteria: * Have recently lost 5% or more of body weight * Are currently taking medications that cause or are influenced by weight loss * Have used weight loss app in the past to lose weight * Family member from same household is enrolled in this study * Type I diabetes or Type II diabetes with insulin dependence **Gender Based:** True **Gender Description:** Participant eligibility is based upon self-representation of gender identity. **Healthy Volunteers:** True **Maximum Age:** 69 Years **Minimum Age:** 40 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Norfolk **Country:** United States **Facility:** University of Nebraska Medical Center **State:** Nebraska **Zip:** 68701 #### Overall Officials **Official 1:** **Affiliation:** University of Nebraska **Name:** Ann M Berger, PhD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** Summary results will be shared with all identifiers removed at the completion of the study after all analyses have been finalized. **IPD Sharing:** NO ### References Module #### References **Citation:** Eisenhauer CM, Hageman PA, Rowland S, Becker BJ, Barnason SA, Pullen CH. Acceptability of mHealth Technology for Self-Monitoring Eating and Activity among Rural Men. Public Health Nurs. 2017 Mar;34(2):138-146. doi: 10.1111/phn.12297. Epub 2016 Oct 18. **PMID:** 27757986 **Citation:** Hageman PA, Pullen CH, Yoerger M. Physical Function and Health-Related Quality of Life in Overweight and Obese Rural Women Who Meet Physical Activity Recommendations. J Aging Phys Act. 2018 Jul 1;26(3):438-444. doi: 10.1123/japa.2017-0117. Epub 2018 Jun 13. **PMID:** 28952857 **Citation:** Hageman PA, Pullen CH, Hertzog M, Pozehl B, Eisenhauer C, Boeckner LS. Web-Based Interventions Alone or Supplemented with Peer-Led Support or Professional Email Counseling for Weight Loss and Weight Maintenance in Women from Rural Communities: Results of a Clinical Trial. J Obes. 2017;2017:1602627. doi: 10.1155/2017/1602627. Epub 2017 Apr 5. **PMID:** 28480078 **Citation:** Eisenhauer CM, Brito FA, Yoder AM, Kupzyk KA, Pullen CH, Salinas KE, Miller J, Hageman PA. Mobile technology intervention for weight loss in rural men: protocol for a pilot pragmatic randomised controlled trial. BMJ Open. 2020 Apr 14;10(4):e035089. doi: 10.1136/bmjopen-2019-035089. **PMID:** 32295776 **Citation:** Eisenhauer CM, Brito F, Kupzyk K, Yoder A, Almeida F, Beller RJ, Miller J, Hageman PA. Mobile health assisted self-monitoring is acceptable for supporting weight loss in rural men: a pragmatic randomized controlled feasibility trial. BMC Public Health. 2021 Aug 18;21(1):1568. doi: 10.1186/s12889-021-11618-7. **PMID:** 34407782 ## Document Section ### Large Document Module #### Large Docs - Date: 2022-05-27 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 395016 - Type Abbrev: Prot_SAP - Upload Date: 2023-10-02T17:16 - Date: 2019-08-21 - Filename: ICF_001.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 212162 - Type Abbrev: ICF - Upload Date: 2022-10-05T18:47 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001836 - Term: Body Weight Changes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5114 - Name: Body Weight - Relevance: HIGH - As Found: Weight - ID: M18102 - Name: Weight Loss - Relevance: HIGH - As Found: Weight Loss - ID: M5115 - Name: Body Weight Changes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001835 - Term: Body Weight - ID: D000015431 - Term: Weight Loss ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Mobile Technology Plus (MT+) **Deaths Num At Risk:** 40 **Description:** Experimental arm will receive a 3-month MT+ intervention using the premium mobile phone app version with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale. Mobile Technology Plus: The intervention group MT+ will receive the premium-version mobile phone app with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale. **ID:** EG000 **Other Num at Risk:** 40 **Serious Number At Risk:** 40 **Title:** Mobile Technology Plus (MT+) **Group ID:** EG001 **Title:** Mobile Technology (MT) **Deaths Num At Risk:** 40 **Description:** Comparison group will receive the basic version of the mobile phone app only. Mobile Technology: The comparison group MT will receive the basic-version mobile phone app only to self monitor eating, activity, and weight. **ID:** EG001 **Other Num at Risk:** 40 **Serious Number At Risk:** 40 **Title:** Mobile Technology (MT) **Frequency Threshold:** 0 **Time Frame:** 1 year, 5 months ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 40 **Group ID:** BG001 **Value:** 40 **Group ID:** BG002 **Value:** 80 **Units:** Participants ### Group **ID:** BG000 **Title:** Mobile Technology Plus (MT+) **Description:** Experimental arm will receive a 3-month MT+ intervention using the premium mobile phone app version with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale. Mobile Technology Plus: The intervention group MT+ will receive the premium-version mobile phone app with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale. ### Group **ID:** BG001 **Title:** Mobile Technology (MT) **Description:** Comparison group will receive the basic version of the mobile phone app only. Mobile Technology: The comparison group MT will receive the basic-version mobile phone app only to self monitor eating, activity, and weight. ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 8.15 **Value:** 54.06 #### Measurement **Group ID:** BG001 **Spread:** 9.10 **Value:** 54.35 #### Measurement **Group ID:** BG002 **Spread:** 8.59 **Value:** 54.20 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 40 #### Measurement **Group ID:** BG001 **Value:** 40 #### Measurement **Group ID:** BG002 **Value:** 80 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 39 #### Measurement **Group ID:** BG001 **Value:** 39 #### Measurement **Group ID:** BG002 **Value:** 78 **Category Title:** Not Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 2 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 1 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 1 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 40 #### Measurement **Group ID:** BG001 **Value:** 38 #### Measurement **Group ID:** BG002 **Value:** 78 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 40 #### Measurement **Group ID:** BG001 **Value:** 40 #### Measurement **Group ID:** BG002 **Value:** 80 **Class Title:** United States **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Ethnicity (NIH/OMB) **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ### Measure 5 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** [email protected] **Organization:** University of Nebraska Medical Center **Phone:** 402-552-7262 **Title:** Kevin Kupzyk ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.9 - **Upper Limit:** - **Value:** -7.03 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 5.85 - **Upper Limit:** - **Value:** -4.14 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.67 - **Upper Limit:** - **Value:** 3.16 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.54 - **Upper Limit:** - **Value:** 3.09 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 6.44 - **Upper Limit:** - **Value:** 4.34 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 17.01 - **Upper Limit:** - **Value:** 10.58 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 4650.58 - **Upper Limit:** - **Value:** 6874.64 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2995.44 - **Upper Limit:** - **Value:** 5359.50 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Weight in kilograms (as measured on a Tanita brand digital scale, TBF-215 Tanita Corporation of America) **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Observed means from baseline weight and at 6 months **Title:** Mean Change in Weight by Randomized Group **Type:** PRIMARY **Unit of Measure:** kilograms ##### Group **Description:** Experimental arm will receive a 3-month MT+ intervention using the premium mobile phone app version with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale. Mobile Technology Plus: The intervention group MT+ will receive the premium-version mobile phone app with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale. **ID:** OG000 **Title:** Mobile Technology Plus (MT+) ##### Group **Description:** Comparison group will receive the basic version of the mobile phone app only. Mobile Technology: The comparison group MT will receive the basic-version mobile phone app only to self monitor eating, activity, and weight. **ID:** OG001 **Title:** Mobile Technology (MT) #### Outcome Measure 2 **Description:** daily fruit and vegetable servings (Brief Risk Factor Surveillance Survey written questionnaire- Fruit and vegetable dietary intake module (Reported total number of fruit and vegetable serving sizes per 24 hour period) **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Observed means from baseline fruit and vegetable intake at 6 months **Title:** Point Estimate and Variability of Outcome Measure for Fruit and Vegetable Intake **Type:** SECONDARY **Unit of Measure:** servings per day ##### Group **Description:** Experimental arm will receive a 3-month MT+ intervention using the premium mobile phone app version with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale. Mobile Technology Plus: The intervention group MT+ will receive the premium-version mobile phone app with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale. **ID:** OG000 **Title:** Mobile Technology Plus (MT+) ##### Group **Description:** Comparison group will receive the basic version of the mobile phone app only. Mobile Technology: The comparison group MT will receive the basic-version mobile phone app only to self monitor eating, activity, and weight. **ID:** OG001 **Title:** Mobile Technology (MT) #### Outcome Measure 3 **Description:** sugar-sweetened total beverage energy intake (Sugar Sweetened beverage intake questionnaire (BEV-Q15) Reported total number of fluid ounces consumed per 24 hour period) **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Observed means from baseline beverage intake and at 6 months **Title:** Point Estimate and Variability of Outcome Measure for Beverage Intake Quality **Type:** SECONDARY **Unit of Measure:** fluid ounces per day ##### Group **Description:** Experimental arm will receive a 3-month MT+ intervention using the premium mobile phone app version with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale. Mobile Technology Plus: The intervention group MT+ will receive the premium-version mobile phone app with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale. **ID:** OG000 **Title:** Mobile Technology Plus (MT+) ##### Group **Description:** Comparison group will receive the basic version of the mobile phone app only. Mobile Technology: The comparison group MT will receive the basic-version mobile phone app only to self monitor eating, activity, and weight. **ID:** OG001 **Title:** Mobile Technology (MT) #### Outcome Measure 4 **Description:** total steps taken in 24 hour period (Automated app report of total steps measured via gyroscope on smart phone- total step count range 0-10,000 steps (higher step value represents desired outcome of 10,000 steps per day) **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Observed means from baseline overall physical activity and at 6 months **Title:** Point Estimate and Variability of Outcome Measure for Physical Activity **Type:** SECONDARY **Unit of Measure:** Activity steps as measured by phone app ##### Group **Description:** Experimental arm will receive a 3-month MT+ intervention using the premium mobile phone app version with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale. Mobile Technology Plus: The intervention group MT+ will receive the premium-version mobile phone app with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale. **ID:** OG000 **Title:** Mobile Technology Plus (MT+) ##### Group **Description:** Comparison group will receive the basic version of the mobile phone app only. Mobile Technology: The comparison group MT will receive the basic-version mobile phone app only to self monitor eating, activity, and weight. **ID:** OG001 **Title:** Mobile Technology (MT) ### Participant Flow Module #### Group **Description:** Experimental arm will receive a 3-month MT+ intervention using the premium mobile phone app version with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale. Mobile Technology Plus: The intervention group MT+ will receive the premium-version mobile phone app with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale. **ID:** FG000 **Title:** Mobile Technology Plus (MT+) #### Group **Description:** Comparison group will receive the basic version of the mobile phone app only. Mobile Technology: The comparison group MT will receive the basic-version mobile phone app only to self monitor eating, activity, and weight. **ID:** FG001 **Title:** Mobile Technology (MT) #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 40 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 40 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 36 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 38 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 4 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 2 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT00457379 **Acronym:** HERCET **Brief Title:** Effect of Exercise Training on the Function of HDL-Cholesterol, Endothelial Function and Endothelial Progenitor Cells in Patients With Coronary Artery Disease (HERCET-Study) **Official Title:** Randomized, Clinical Trial to Study the Effect of Exercise Training on the Function of HDL-Cholesterol, Endothelial Function, Oxidative Stress and Regenerative Capacity of Endothelial Progenitor Cells in Patients With Coronary Artery Disease #### Organization Study ID Info **ID:** 4031214 #### Organization **Class:** OTHER **Full Name:** Hannover Medical School ### Status Module #### Completion Date **Date:** 2008-04 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2007-08-15 **Type:** ESTIMATED **Last Update Submit Date:** 2007-08-14 **Overall Status:** UNKNOWN #### Start Date **Date:** 2007-04 **Status Verified Date:** 2007-04 #### Study First Post Date **Date:** 2007-04-06 **Type:** ESTIMATED **Study First Submit Date:** 2007-04-04 **Study First Submit QC Date:** 2007-04-04 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hannover Medical School ### Description Module **Brief Summary:** Patients with coronary artery disease are characterized by an increased cardiovascular risk and they often have low blood high density lipoprotein (HDL)-cholesterol levels or HDL-cholesterol with modified vasculoprotective properties. The purpose of the present study is to characterize the quality of HDL-cholesterol in patients with coronary artery disease and normal blood HDL-cholesterol levels and to examine the effect of exercise training on the vasculoprotective effects of HDL-cholesterol in these patients. Additionally, the researchers aim to investigate the endothelial function, oxidative stress and the regenerative capacity of the endothelial progenitor cells in patients with coronary artery disease and the changes dependent on physical activity of patients. ### Conditions Module **Conditions:** - Coronary Artery Disease **Keywords:** - Coronary artery disease - HDL-Cholesterol - Endothelial Function - Endothelial Progenitor Cells - normal blood HDL-Cholesterol level ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** physical exercise **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Measure:** vasculoprotective and regenerative functions of HDL-cholesterol before and after 8-weeks of exercise training #### Secondary Outcomes **Measure:** flow-mediated, endothelium-dependent vasodilation of radial artery measured by ultrasound ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Coronary artery disease * Normal HDL-cholesterol levels in blood: * \> 40 mg/dl (1.03 mmol/L) in males * \> 50 mg/dl (1.29 mmol/L) in females Exclusion Criteria: * Type 1 or 2 diabetes mellitus * Acute coronary syndrome * Unstable angina pectoris * Myocardial infarction during the last 8 weeks * Therapy with niacin * Active infections * Ventricular arrhythmias * Systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 95 mmHg * Cancer * Pregnant or lactating * Alcoholism **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ulf Landmesser, MD **Phone:** +49511532 **Phone Ext:** 2229 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Kristina Sonnenschein **Phone:** +49511532 **Phone Ext:** 5402 **Role:** CONTACT #### Locations **Location 1:** **City:** Hannover **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ulf Landmesser, MD - **Phone:** +49511532 - **Phone Ext:** 2229 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Kristina Sonnenschein - **Phone:** +49511532 - **Phone Ext:** 5402 - **Role:** CONTACT ***Contact 3:*** - **Name:** Ulf Landmesser, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Germany **Facility:** Hannover Medical School **Status:** RECRUITING **Zip:** 30625 #### Overall Officials **Official 1:** **Affiliation:** Hannover Medical School **Name:** Helmut Drexler, MD **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Hannover Medical School **Name:** Ulf Landmesser, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** Hannover Medical School **Name:** Kristina Sonnenschein, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000001161 - Term: Arteriosclerosis - ID: D000001157 - Term: Arterial Occlusive Diseases - ID: D000014652 - Term: Vascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M6549 - Name: Coronary Disease - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M6546 - Name: Coronary Artery Disease - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M19506 - Name: Myocardial Ischemia - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M4469 - Name: Arteriosclerosis - Relevance: LOW - As Found: Unknown - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003324 - Term: Coronary Artery Disease - ID: D000017202 - Term: Myocardial Ischemia - ID: D000003327 - Term: Coronary Disease ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03685279 **Brief Title:** Efficacy of the Nurtured Heart Approach to Reduce ADHD Behaviors in Children **Official Title:** Testing the Efficacy of the Nurtured Heart Approach: A Randomized Controlled Trial #### Organization Study ID Info **ID:** 1707672022 #### Organization **Class:** OTHER **Full Name:** University of Arizona ### Status Module #### Completion Date **Date:** 2018-06-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-09-26 **Type:** ACTUAL **Last Update Submit Date:** 2018-09-24 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2018-06-30 **Type:** ACTUAL #### Start Date **Date:** 2017-08-14 **Type:** ACTUAL **Status Verified Date:** 2018-09 #### Study First Post Date **Date:** 2018-09-26 **Type:** ACTUAL **Study First Submit Date:** 2018-08-28 **Study First Submit QC Date:** 2018-09-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Arizona #### Responsible Party **Investigator Affiliation:** University of Arizona **Investigator Full Name:** Velia Nuno **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study evaluates the efficacy of the Nurtured Heart Approach (NHA) to reduce inattention and hyperactivity and impulsivity in children ages 6 - 8 years. Participants are parents or guardians of children diagnosed with, or suspected of, attention deficit hyperactivity disorder (ADHD). Participants are randomized into the immediate (NHA) or delayed (Control) group. **Detailed Description:** The American Academy of Pediatrics recommends evidence-based parent and/or teacher behavioral therapy and/or medication to treat ADHD. A systematic review by Coates and colleagues found behavioral interventions decreased ADHD behaviors in children. The NHA is an intervention designed to teach parents a set of skills and attitudes to decrease ADHD in children. It has been applied in a number of settings from homes, schools, and foster care agencies both in several states in the U.S. and in over 16 countries. While widely accepted, the Approach has not been evaluated using scientifically rigorous methods. ### Conditions Module **Conditions:** - Attention Deficit Hyperactivity Disorder ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 104 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Six-week, online intervention with weekly, sequential, content knowledge and skills practice. Each week included recorded, slide presentations (narrated by the developer of the NHA, Howard Glasser); readings from "The Transforming the Intense Child Workbook" by Howard Glasser with Melissa Lowenstein; participants' skills practice, web postings, and live sessions with Howard Glasser and Advanced NHA Trainers. **Intervention Names:** - Behavioral: Nurtured Heart Approach **Label:** NHA Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The Control Group received the same intervention after the collection of NHA Group post-intervention surveys. **Intervention Names:** - Behavioral: Nurtured Heart Approach **Label:** Control Group **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Control Group - NHA Group **Description:** Based on three stands designed to reduce negative reactivity from parents/guardians, increase positive interactions, and set firm, clear limits. **Name:** Nurtured Heart Approach **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Parent reported measure called Conners-3 Parent Short Form. Raw scores are converted into standardized T-scores using age- and sex-specific conversion standards. The minimum T-score is 40 and the maximum is 90. The six content subscales are inattention, hyperactivity/impulsivity, learning problems, executive function, defiance/aggression, and peer relations. Higher T-scores are worse. **Measure:** Inattention **Time Frame:** Six-week change from pre-intervention inattention to post-intervention inattention. **Description:** Parent reported measure called Conners-3 Parent Short Form. Raw scores are converted into standardized T-scores using age- and sex-specific conversion standards. The minimum T-score is 40 and the maximum is 90. The six content subscales are inattention, hyperactivity/impulsivity, learning problems, executive function, defiance/aggression, and peer relations. Higher T-scores are worse. **Measure:** Hyperactivity/Impulsivity **Time Frame:** Six-week change from pre-intervention hyperactivity/impulsivity to post-intervention hyperactivity/impulsivity. #### Secondary Outcomes **Description:** Parent reported measure called Parenting Stress Index - 4 Short Form. Scores are summed. A minimum raw score possible is 36 and maximum is 180. Higher values are worse. **Measure:** Parental Stress **Time Frame:** Six-week change from pre-intervention parental stress to post-intervention parental stress. **Description:** Parent reported measure called Parenting Sense of Competence. Scores are summed. A minimum score possible is 16 and maximum is 96. Higher value is a better outcome. **Measure:** Parenting Competency **Time Frame:** Six-week change from pre-intervention parenting competency to post-intervention parenting competency. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Parent or guardian of a child diagnosed with ADHD or suspected of ADHD * Child must be 6 - 8 years of age * Access to a computer with Internet Exclusion Criteria: * Child with ADHD, or suspected of ADHD, cannot have a diagnosis of autism **Healthy Volunteers:** True **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Tucson **Country:** United States **Facility:** University of Arizona **State:** Arizona **Zip:** 85724 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019958 - Term: Attention Deficit and Disruptive Behavior Disorders - ID: D000065886 - Term: Neurodevelopmental Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M4594 - Name: Attention Deficit Disorder with Hyperactivity - Relevance: HIGH - As Found: Attention Deficit Hyperactivity Disorder - ID: M9999 - Name: Hyperkinesis - Relevance: LOW - As Found: Unknown - ID: M21830 - Name: Attention Deficit and Disruptive Behavior Disorders - Relevance: LOW - As Found: Unknown - ID: M30644 - Name: Neurodevelopmental Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001289 - Term: Attention Deficit Disorder with Hyperactivity ### Intervention Browse Module - Browse Branches - Abbrev: HB - Name: Herbal and Botanical - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T206 - Name: Lemon Balm - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06391879 **Brief Title:** Establishment of a Multidimensional Prediction Model for the Natural Course of VHL Disease-related Renal Cell Carcinoma **Official Title:** Establishment of a Multidimensional Prediction Model for the Natural Course of VHL Disease-related Renal Cell Carcinoma Based on Accurate Genotyping: a Population-based Study #### Organization Study ID Info **ID:** 2023#395-002 #### Organization **Class:** OTHER **Full Name:** Peking University First Hospital ### Status Module #### Completion Date **Date:** 2025-08-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-04-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-04-29 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2023-09-08 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-04-30 **Type:** ACTUAL **Study First Submit Date:** 2024-04-25 **Study First Submit QC Date:** 2024-04-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Peking University First Hospital #### Responsible Party **Investigator Affiliation:** Peking University First Hospital **Investigator Full Name:** GONG Kan **Investigator Title:** Chief physician **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** VHL syndrome is a rare hereditary tumor syndrome caused by mutation of tumor suppressor gene VHL. One of the most important clinical manifestations and main cause of death is VHL-related renal cell carcinoma (RCC). Facing the challenges of multilesion of both kidneys, slow progress and life-long repeated surgeries in VHL-related RCC, individualized prediction of the best surgical treatment time and reduction of times of surgeries are very important to improve the prognosis of patients with VHL syndrome. Therefore, there is an urgent need to establish a more effective and accurate prediction model for the natural course of VHL syndrome. This cohort-study aims to retrospectively and prospectively analyze the factors related to the natural course of VHL-related RCC. At the same time, some patients were selected for prospectively continuous molecular evolution dynamic monitoring after comprehensively considering the results of single cell sequencing, whole genome and metabonomic sequencing. This study will provide scientific basis for accurate diagnosis and treatment of natural course of VHL-related RCC. **Detailed Description:** VHL syndrome is a rare hereditary tumor syndrome caused by mutation of tumor suppressor gene VHL. One of the most important clinical manifestations and main cause of death is VHL-related renal cell carcinoma (RCC). Previous small sample studies have confirmed that the natural course of VHL-related RCC is different from that of sporadic RCC. Facing the challenges of multilesion of both kidneys, slow progress and life-long repeated surgeries in VHL-related RCC, individualized prediction of the best surgical treatment time and reduction of times of surgeries are very important to improve the prognosis of patients with VHL-related RCC. Therefore, there is an urgent need to establish a more effective and accurate prediction model for the natural course of VHL syndrome. Based on the previous establishment of the largest biobank of VHL syndrome in Asia, as well as the unique characteristics and genotype-phenotypic relationship of patients in Chinese population, this cohort-study aims to retrospectively and prospectively analyze the factors related to the natural course of VHL-related RCC. At the same time, some patients were selected for prospectively continuous molecular evolution dynamic monitoring after comprehensively considering the results of single cell sequencing, whole genome and metabonomic sequencing. This study will systematically analyze the specific molecular characteristic and evolution of VHL-related different from sporadic RCC, reveal new specific driving genes and their molecular regulatory mechanisms, and establish a multi-dimensional prediction model of natural course of VHL-related RCC based on accurate genotyping. It will provide scientific basis for accurate diagnosis and treatment of natural course of VHL-related RCC. ### Conditions Module **Conditions:** - VHL Syndrome - Renal Cell Carcinoma **Keywords:** - VHL - VHL syndrome - Renal cell carcinoma ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This cohort incorporates subjects with VHL-related renal cell carcinoma. **Intervention Names:** - Genetic: Single cell sequencing, whole genome and metabolomic sequencing **Label:** VHL-related RCC cohort ### Interventions #### Intervention 1 **Arm Group Labels:** - VHL-related RCC cohort **Description:** The blood specimen of subjects in this cohort would be collected to conduct single cell sequencing, whole genome and metabolomic sequencing. **Name:** Single cell sequencing, whole genome and metabolomic sequencing **Type:** GENETIC ### Outcomes Module #### Primary Outcomes **Description:** The tumor size was measured annually and the tumor growth rate was calculated. **Measure:** Tumor growth rate **Time Frame:** From date of diagnosis of the VHL-related RCC until the date of surgical treatment, death from any cause or the date of last follow-up, whichever came first, assessed up to 60 years. #### Secondary Outcomes **Description:** OS was calculated as the time interval from the diagnosis of the VHL-related RCC to death or the time to the last follow-up. **Measure:** Overall survival (OS) **Time Frame:** From date of diagnosis of the VHL-related RCC until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 20 years. **Description:** CSS was calculated as the time interval from the diagnosis of the VHL-related RCC to death from the same disease or the last follow-up. **Measure:** Cancer-specific survival (CSS) **Time Frame:** From date of diagnosis of the VHL-related RCC until the date of death from the same disease or the date of last follow-up, whichever came first, assessed up to 20 years. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosis of VHL syndrome based on clinical diagnostic criteria or genetic test results of syndrome * Upon enrollment, multiple organ assessments for VHL syndrome should be completed, including fundus examination, CT/MR examination of the brain, spinal cord, and abdominal and pelvic organs. * If subjects have undergone surgery for renal tumors, the follow-up observation time in each branch center before surgery should be more than 12 months, and imaging examinations should be performed at least once every 6 months. Exclusion Criteria: * Do not meet the clinical diagnostic criteria for VHL disease or the genetic test is negative * Other hereditary RCC syndromes **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Based on the previous establishment of the largest biobank of VHL syndrome in Asia, as well as the unique characteristics and genotype-phenotypic relationship of patients in Chinese population, this cohort-study aims to retrospectively and prospectively incorporated patients with VHL-related RCC. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Kan Gong **Phone:** (86)-010-83572075 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yanyan Yu - **Phone:** +86 1066119025 - **Role:** CONTACT **Country:** China **Facility:** Peking University First Hospital **State:** Beijing **Status:** RECRUITING **Zip:** 100034 #### Overall Officials **Official 1:** **Affiliation:** Peking University First Hospital **Name:** Kan Gong **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000000230 - Term: Adenocarcinoma - ID: D000007680 - Term: Kidney Neoplasms - ID: D000014571 - Term: Urologic Neoplasms - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000007674 - Term: Kidney Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000020752 - Term: Neurocutaneous Syndromes - ID: D000009422 - Term: Nervous System Diseases - ID: D000000798 - Term: Angiomatosis - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000072661 - Term: Ciliopathies - ID: D000000015 - Term: Abnormalities, Multiple - ID: D000000013 - Term: Congenital Abnormalities - ID: D000030342 - Term: Genetic Diseases, Inborn ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M5548 - Name: Carcinoma, Renal Cell - Relevance: HIGH - As Found: Renal Cell Carcinoma - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M9699 - Name: Von Hippel-Lindau Disease - Relevance: HIGH - As Found: VHL Syndrome - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M10703 - Name: Kidney Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17320 - Name: Urologic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M22509 - Name: Neurocutaneous Syndromes - Relevance: LOW - As Found: Unknown - ID: M4126 - Name: Angiomatosis - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M1076 - Name: Ciliopathies - Relevance: LOW - As Found: Unknown - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M14 - Name: Abnormalities, Multiple - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: T4906 - Name: Renal Cell Carcinoma - Relevance: HIGH - As Found: Renal Cell Carcinoma - ID: T1341 - Name: Clear Cell Renal Cell Carcinoma - Relevance: HIGH - As Found: Renal Cell Carcinoma - ID: T5876 - Name: Von Hippel-Lindau Disease - Relevance: HIGH - As Found: VHL Syndrome ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000002292 - Term: Carcinoma, Renal Cell - ID: D000006623 - Term: Von Hippel-Lindau Disease ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02563379 **Acronym:** DIMOSPAF **Brief Title:** Association of Dipping Pattern or Early Morning Surge of BP With Asymptomatic Episodes of Paroxysmal Atrial Fibrillation in Subjects With Hypertension (DIMOSPAF) **Official Title:** Association Between Circadian Blood Pressure Patterns With Asymptomatic Episodes of Paroxysmal Atrial Fibrillation in Hypertensive Subjects #### Organization Study ID Info **ID:** MBPS-0915-EA #### Organization **Class:** OTHER **Full Name:** Evangelismos Hospital ### Status Module #### Completion Date **Date:** 2016-09 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** NOT_YET_RECRUITING #### Last Update Post Date **Date:** 2015-10-01 **Type:** ESTIMATED **Last Update Submit Date:** 2015-09-30 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2016-03 **Type:** ESTIMATED #### Start Date **Date:** 2015-09 **Status Verified Date:** 2015-09 #### Study First Post Date **Date:** 2015-09-30 **Type:** ESTIMATED **Study First Submit Date:** 2015-09-28 **Study First Submit QC Date:** 2015-09-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Evangelismos Hospital #### Responsible Party **Investigator Affiliation:** Evangelismos Hospital **Investigator Full Name:** Emmanuel A. Andreadis **Investigator Title:** HEAD OF THE FOURTH INTERNAL MEDICINE DEPARTMENT **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goals of our study are to determine a).the association between abnormal circadian BP and the development of paroxysmal AF in hypertensive patients, b).at which level of TOD, paroxysmal AF episodes are detected in hypertensive subjects, c).if there is any association between systolic and/or diastolic BP levels with AF occurrence, d).whether the mean heart rate during a 24-hr interval is associated with the development of paroxysmal AF, and finally e).examine the relationship between a wide PP and asymptomatic AF episodes in patients with HTN. **Detailed Description:** Atrial fibrillation, also known as AF or Afib, is an abnormal and irregular heart rhythm in which electrical signals are generated chaotically throughout the upper chambers (atria) of the heart. According to the NICE clinical guidelines, a patient who experiences recurrent (two or more) AF episodes that terminate spontaneously without any treatment in less than seven days, and usually within 48 hours is classified as having paroxysmal AF. It has been shown that paroxysmal AF comprises approximately between 25% and 62% of cases of AF, and it is estimated that both its incidence and prevalence are likely to rise as the worldwide population ages dramatically over the next twenty years. Interestingly, hospitalizations due to AF have increased sharply in the US during the last decade, posing thereby a heavy economic burden on the health care system and society. Likewise, hypertension (HTN) also constitutes a major public health problem globally, and its prevalence is set to increase owing to widespread population ageing. This epidemiological trend is especially prevalent in rapidly developing countries where early routine screening at any point of health care is underutilized among risk subjects, due to several perceived barriers. Moreover, HTN awareness is critical for optimal BP control since under-diagnosis, under-treatment and/or un-treatment of high BP levels can have deleterious effects on the cardiovascular system. In addition, HTN is the single most important risk factor for cerebrovascular stroke, and it has been clearly demonstrated that it is also associated with structural and functional changes in the myocardium that favor the development of AF, further increasing the risk of thromboembolism. Among those alterations, left ventricular hypertrophy (LVH), impaired ventricular filling, left atrial enlargement and slowing of atrial conduction velocity have been identified as important heralds of cardiovascular morbidity and mortality. More specifically, since HTN and AF are two conditions that often co-exist, especially in patients with advanced age, the risk for considerable morbidity and mortality is increased even more, which points towards the significance that optimal BP control holds in the prevention of cardiovascular events. To our knowledge, in the Framingham Heart Study, after controlling for age and other predisposing conditions, HTN and diabetes emerged as the only cardiovascular risk factors predicting AF. It has also been suggested that nocturnal HTN and non-dipping of BP during sleep are distinct entities that often occur together and are regarded as important harbingers of poor cardiovascular prognosis. Recently, Pierdomenico et al., showed that non-dipper sustained hypertensives have a two-fold greater risk of developing AF than dipper ones. This may be due to the fact that nighttime HTN may be a powerful determinant of long-standing left ventricular diastolic dysfunction, which subsequently increases atrial stretch. Furthermore, it has been observed that nighttime hemodynamics, are associated with higher sympathetic and reduced vagal activity, which may trigger AF. Additionally, sympathetic activation is associated with the stimulation of the renin-angiotensin-aldosterone axis (RAAA), which leads to increased left ventricular diastolic preload, both atrial and ventricular fibrosis, exerting thus direct cellular electrophysiological effects. Besides, scientists suggested that nighttime HTN is better associated with cardiovascular target organ damage (TOD) as compared with the non-dipping pattern. According to the most recent guidelines of the ESH, the presence of microalbuminuria, increased pulse wave velocity, LVH on echocardiogram and carotid plaques detected during carotid ultrasonography, constitute markers of asymptomatic organ damage and it has been clearly demonstrated from multiple studies that they can predict CV mortality independently of SCORE stratification. In our study we will try to investigate whether abnormalities in the circadian rhythm of BP (such as extreme dipping or non-dipping pattern, and/or morning surge) in hypertensive subjects with or without TOD are associated with the development of new-onset paroxysmal AF. 24-hr ambulatory BP monitoring (ABPM) along with the 24-hour blood pressure monitors with AF detector will help us to examine the incidence of AF in extremely dippers or non-dippers, and/or patients exhibiting a morning surge in BP, with or without TOD. Some of the questions that we aim to answer while conducting this study are whether an asymptomatic AF episode is more commonly detected in extreme dippers, non-dippers, or morning surgers, during daytime or during nighttime, or whether TOD is associated with asymptomatic AF episodes. Importantly, Iqbal et al, demonstrated that there is an association between AF and nighttime DBP. On top of that, during the past decade, a research study conducted in 546 hypertensive subjects aged \< 60 years of age and who were followed-up for 9.2 years, showed that DBP, whether 24-hr mean, daytime mean, or nighttime mean, provided the most incremental value for the prediction of morbid events. Thereby, we want to examine if AF episodes have any association with the 24hr systolic and the diastolic blood pressure (DBP) levels. It would also be interesting to observe for any associations between AF occurrence and the mean 24-hr ABPM and office heart rate (HR). Moreover, it has been showed that pulse pressure (PP) determines left atrial enlargement in non-dipper patients with never-treated essential HTN. Thus, in our study, we will also examine whether a wide PP is associated with silent AF episodes in treated hypertensive subjects. Summarizing, the goals of our study are to determine a).the association between abnormal circadian BP and the development of paroxysmal AF in hypertensive patients, b).at which level of TOD, paroxysmal AF episodes are detected in hypertensive subjects, c).if there is any association between systolic and/or diastolic BP levels with AF occurrence, d).whether the mean heart rate during a 24-hr interval is associated with the development of paroxysmal AF, and finally e).examine the relationship between a wide PP and asymptomatic AF episodes in patients with HTN. Study Population We will evaluate all adult patients referred by their family physicians to the "Hypertension and Cardiovascular Prevention" Outpatient Clinic at Evangelismos General Hospital in Athens, from June 2015 to present. All patients with an average office systolic BP ≥140 mmHg and/or an average diastolic BP ≥90 mmHg on three consecutive visits are considered as having essential HTN. Furthermore, individuals under treatment with one or more antihypertensive drug are also enrolled in the study. Objectives Primary endpoint • To investigate whether nighttime BP patterns (extreme dipping, normal dipping or reduced dipping and non-dipping including risers) or early morning surge are associated with the detection of paroxysmal AF in hypertensive subjects. Further definitions Normal diurnal systolic and diastolic BP pattern: arterial BP has a daily variation characterized by substantial reductions during sleep, a rapid rise upon awakening, and increased variability during the awake period in ambulant normal subjects and hypertensive patients. Reduced diurnal systolic and diastolic BP pattern: nocturnal systolic and/or DBP fall from 1 to 10% of daytime values or night/day systolic and/or diastolic BP ratio \<1 and \>0.9. Nocturnal HTN: increased absolute level of night time systolic and/or diastolic BP (≥120/70 mmHg).19 Dipping pattern is defined as daytime-nighttime BP/daytime BP reduction - based on either ABP or home BP (HBP) monitoring- greater than 10% for systolic and/or diastolic BP. Nighttime HTN is defined as nighttime ABP or HBP ≥125/75 mmHg (systolic and/or diastolic). Non-dipping and rising: no reduction or increase in nocturnal systolic and/or diastolic BP or night/day systolic and/or diastolic BP ratio ≥1. Extreme dipping: marked nocturnal systolic and/or diastolic BP fall\>20% of daytime systolic and/or diastolic values or night/day systolic and/or diastolic BP ratio \<0.8. Morning surge: excessive systolic and/or diastolic BP elevation rising in the morning. Secondary endpoints * To detect asymptomatic and intermittent AF using a 24h ABPM with atrial fibrillation detector device and to compare its accuracy with Holter monitoring. * To investigate the agreement in the detection of paroxysmal AF using simultaneously the 24h-ABP with AF detection device and loop recording. * To observe at which level of TOD, asymptomatic AF episodes are more commonly detected. * To study if there is any relationship between systolic and/or diastolic BP levels with AF occurrence. * To examine whether office HR or mean HR using ABPM is associated with the development of silent AF episodes. * To examine whether a wide PP in ABPM is associated with the development of silent AF episodes. Variables used to determine the primary and secondary endpoints * Sociodemographic data (birth date, gender, education level, employment status, place of residence, smoking status/habits, alcohol consumption) * Anthropometric characteristics (body weight, height, waist circumference) * Any abnormal findings on physical examination * Clinical relevant medical history and comorbidities * Concomitant medications * Electrocardiographic assessment * Investigation of TOD, including echocardiography, carotid artery triplex, 24h-urine albumin excretion and ABI * Recent laboratory testing results including hemoglobin, hematocrit, blood glucose, kidney and liver function tests * Management of HTN (pharmacologic and non-pharmacologic treatment) Inclusion Criteria * Patients diagnosed with essential HTN (office BP\>140/90mmHg) or patients receiving at least one antihypertensive medication (ie. RAAA inhibitors or diuretic), aged 18-85 years of age. * Patients with at least one of the following risk factors, organ damage or other evidence of cardiovascular disease: * Previous stroke * Transient ischemic attack (TIA) * Systemic embolism * Diabetes mellitus type 2 * Obesity * Obstructive sleep apnea (OSA) * Dyslipidemia * History of coronary artery disease (CAD) * Valvular heart disease (VHD) * Echocardiographic findings attributed to HTN (ie. diastolic dysfunction, LVH) * White coat hypertension (WCH), masked hypertension (MH) * Positive family history for rhythm disturbances Exclusion Criteria * Patients already diagnosed with paroxysmal or permanent AF * Severe renal insufficiency (eGFR according to MDRD formula \<25ml/min/1.73m2) * Patients unable to attend follow-up visits * Clinical evidence of severe heart failure * Suspected secondary HTN * Mental disorders * Patients with cancer The study protocol needs to be approved by the scientific board of the hospital and signed informed consent needs to be obtained from all participants. Study Design We are going to conduct a cross-sectional, observational study. ### Conditions Module **Conditions:** - Hypertension - Atrial Fibrillation ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 12 Months ### Arms Interventions Module #### Arm Group 1 **Description:** Dipping pattern is defined as daytime-nighttime BP/daytime BP reduction - based on either ABP monitoring- greater than 10% for systolic and/or diastolic BP. Extreme dipping is marked nocturnal systolic and/or diastolic BP fall\>20% of daytime systolic and/or diastolic values or night/day systolic and/or diastolic BP ratio \<0.8. Patients in this group will be dippers or extreme dippers. We aim to examine the association of this BP pattern with the development of asymptomatic episodes of paroxysmal atrial fibrillation, in hypertensive subjects. **Label:** Dippers #### Arm Group 2 **Description:** Non-dipping and rising: no reduction or increase in nocturnal systolic and/or diastolic BP or night/day systolic and/or diastolic BP ratio ≥1. In this group we aim to examine whether an association exists between the non-dipping pattern and the development of asymptomatic episodes of paroxysmal atrial fibrillation in hypertensive subjects. **Label:** Non-dippers #### Arm Group 3 **Description:** It is known that morning surge is the excessive systolic and/or diastolic BP elevation rising in the morning. Patients in this group will have morning hypertension that is classified into two types: the "morning-surge" type, characterized by a marked increase in blood pressure in the early morning, and the "nocturnal-hypertension" type, characterized by high blood pressure that persists from nighttime until early morning. In our study we will examine whether an association between morning hypertension and asymptomatic episodes of paroxysmal atrial fibrillation exists in hypertensive subjects. **Label:** Morning Hypertensives ### Outcomes Module #### Primary Outcomes **Description:** • To investigate whether nighttime BP patterns (extreme dipping, normal dipping or reduced dipping and non-dipping including risers) or early morning surge are associated with the detection of paroxysmal AF in hypertensive subjects. **Measure:** Association between nighttime BP patterns and/or early morning surge with the development of asymptomatic episodes of paroxysmal atrial fibrillation in hypertensive subjects **Time Frame:** 12 months #### Secondary Outcomes **Description:** • To observe at which level of TOD, asymptomatic AF episodes are more commonly detected. **Measure:** Association between the degree of TOD and the development of paroxysmal AF in hypertensive patients **Time Frame:** 12 months **Description:** • To study if there is any relationship between systolic and/or diastolic BP levels with AF occurrence. **Measure:** Association between SBP and/or DBP levels with the development of paroxysmal AF in hypertensive patients **Time Frame:** 12 months **Description:** • To examine whether office HR or mean HR using ABPM is associated with the development of silent AF episodes. **Measure:** Association between office heart rate or mean 24-hr heart rate with the development of asymptomatic paroxysmal AF episodes. **Time Frame:** 12 months **Description:** • To examine whether a wide PP in ABPM is associated with the development of silent AF episodes. **Measure:** Association between PP and the development of asymptomatic paroxysmal AF episodes **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients diagnosed with essential HTN (office BP\>140/90mmHg) or patients receiving at least one antihypertensive medication (ie. RAAA inhibitors or diuretic), aged 18-85 years of age. * Patients with at least one of the following risk factors, organ damage or other evidence of cardiovascular disease: * Previous stroke * Transient ischemic attack (TIA) * Systemic embolism * Diabetes mellitus type 2 * Obesity * Obstructive sleep apnea (OSA) * Dyslipidemia * History of coronary artery disease (CAD) * Valvular heart disease (VHD) * Echocardiographic findings attributed to HTN (ie. diastolic dysfunction, LVH) * White coat hypertension (WCH), masked hypertension (MH) * Positive family history for rhythm disturbances Exclusion Criteria: * Patients already diagnosed with paroxysmal or permanent AF * Severe renal insufficiency (eGFR according to MDRD formula \<25ml/min/1.73m2) * Patients unable to attend follow-up visits * Clinical evidence of severe heart failure * Suspected secondary HTN * Mental disorders * Patients with cancer **Maximum Age:** 85 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** We will evaluate all adult patients referred by their family physicians to the "Hypertension and Cardiovascular Prevention" Outpatient Clinic at Evangelismos General Hospital in Athens, from June 2015 to present. All patients with an average office systolic BP ≥140 mmHg and/or an average diastolic BP ≥90 mmHg on three consecutive visits are considered as having essential HTN. Furthermore, individuals under treatment with one or more antihypertensive drug are also enrolled in the study. ### Contacts Locations Module #### Locations **Location 1:** **City:** Athens **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Emmanuel A. Andreadis, MD - **Phone:** +30210-7205149 - **Role:** CONTACT ***Contact 2:*** - **Name:** Emmanuel A. Andreadis, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Greece **Facility:** Evangelismos General Hospital **State:** Attiki **Zip:** 10676 ### References Module #### References **Citation:** Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, DiMarco J, Edgerton J, Ellenbogen K, Ezekowitz MD, Haines DE, Haissaguerre M, Hindricks G, Iesaka Y, Jackman W, Jalife J, Jais P, Kalman J, Keane D, Kim YH, Kirchhof P, Klein G, Kottkamp H, Kumagai K, Lindsay BD, Mansour M, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Nakagawa H, Natale A, Nattel S, Packer DL, Pappone C, Prystowsky E, Raviele A, Reddy V, Ruskin JN, Shemin RJ, Tsao HM, Wilber D. 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design. Europace. 2012 Apr;14(4):528-606. doi: 10.1093/europace/eus027. Epub 2012 Mar 1. No abstract available. **PMID:** 22389422 **Citation:** Lip GY, Hee FL. Paroxysmal atrial fibrillation. QJM. 2001 Dec;94(12):665-78. doi: 10.1093/qjmed/94.12.665. **PMID:** 11744787 **Citation:** Colilla S, Crow A, Petkun W, Singer DE, Simon T, Liu X. Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population. Am J Cardiol. 2013 Oct 15;112(8):1142-7. doi: 10.1016/j.amjcard.2013.05.063. Epub 2013 Jul 4. **PMID:** 23831166 **Citation:** Patel NJ, Deshmukh A, Pant S, Singh V, Patel N, Arora S, Shah N, Chothani A, Savani GT, Mehta K, Parikh V, Rathod A, Badheka AO, Lafferty J, Kowalski M, Mehta JL, Mitrani RD, Viles-Gonzalez JF, Paydak H. Contemporary trends of hospitalization for atrial fibrillation in the United States, 2000 through 2010: implications for healthcare planning. Circulation. 2014 Jun 10;129(23):2371-9. doi: 10.1161/CIRCULATIONAHA.114.008201. Epub 2014 May 19. **PMID:** 24842943 **Citation:** Tibazarwa KB, Damasceno AA. Hypertension in developing countries. Can J Cardiol. 2014 May;30(5):527-33. doi: 10.1016/j.cjca.2014.02.020. Epub 2014 Mar 4. Erratum In: Can J Cardiol. 2014 Jul;30(7):834. **PMID:** 24786443 **Citation:** Sarafidis PA, Li S, Chen SC, Collins AJ, Brown WW, Klag MJ, Bakris GL. Hypertension awareness, treatment, and control in chronic kidney disease. Am J Med. 2008 Apr;121(4):332-40. doi: 10.1016/j.amjmed.2007.11.025. **PMID:** 18374693 **Citation:** Rundek T, Sacco RL. Risk factor management to prevent first stroke. Neurol Clin. 2008 Nov;26(4):1007-45, ix. doi: 10.1016/j.ncl.2008.09.001. **PMID:** 19026901 **Citation:** Healey JS, Connolly SJ. Atrial fibrillation: hypertension as a causative agent, risk factor for complications, and potential therapeutic target. Am J Cardiol. 2003 May 22;91(10A):9G-14G. doi: 10.1016/s0002-9149(03)00227-3. **PMID:** 12781903 **Citation:** Kannel WB, Wolf PA, Benjamin EJ, Levy D. Prevalence, incidence, prognosis, and predisposing conditions for atrial fibrillation: population-based estimates. Am J Cardiol. 1998 Oct 16;82(8A):2N-9N. doi: 10.1016/s0002-9149(98)00583-9. **PMID:** 9809895 **Citation:** de la Sierra A, Gorostidi M, Banegas JR, Segura J, de la Cruz JJ, Ruilope LM. Nocturnal hypertension or nondipping: which is better associated with the cardiovascular risk profile? Am J Hypertens. 2014 May;27(5):680-7. doi: 10.1093/ajh/hpt175. Epub 2013 Sep 23. **PMID:** 24061070 **Citation:** Pierdomenico SD, Lapenna D, Cuccurullo F. Risk of atrial fibrillation in dipper and nondipper sustained hypertensive patients. Blood Press Monit. 2008 Aug;13(4):193-7. doi: 10.1097/MBP.0b013e3282feea70. **PMID:** 18635973 **Citation:** Tsioufis C, Andrikou I, Thomopoulos C, Syrseloudis D, Stergiou G, Stefanadis C. Increased nighttime blood pressure or nondipping profile for prediction of cardiovascular outcomes. J Hum Hypertens. 2011 May;25(5):281-93. doi: 10.1038/jhh.2010.113. Epub 2010 Dec 2. **PMID:** 21124340 **Citation:** Iqbal P, Stevenson L. Cardiovascular outcomes in patients with normal and abnormal 24-hour ambulatory blood pressure monitoring. Int J Hypertens. 2010 Dec 5;2011:786912. doi: 10.4061/2011/786912. **PMID:** 21151547 **Citation:** Khattar RS, Swales JD, Dore C, Senior R, Lahiri A. Effect of aging on the prognostic significance of ambulatory systolic, diastolic, and pulse pressure in essential hypertension. Circulation. 2001 Aug 14;104(7):783-9. doi: 10.1161/hc3201.094227. **PMID:** 11502703 **Citation:** Triantafyllidi H, Ikonomidis I, Lekakis J, Panou F, Georgoula G, Fountoulaki K, Kremastinos D. Pulse pressure determines left atrial enlargement in non-dipper patients with never-treated essential hypertension. J Hum Hypertens. 2007 Nov;21(11):897-9. doi: 10.1038/sj.jhh.1002236. Epub 2007 May 31. No abstract available. **PMID:** 17541387 **Citation:** Deyneli O, Yazici D, Toprak A, Yuksel M, Aydin H, Tezcan H, Yavuz DG, Akalin S. Diurnal blood pressure abnormalities are related to endothelial dysfunction in patients with non-complicated type 1 diabetes. Hypertens Res. 2008 Nov;31(11):2065-73. doi: 10.1291/hypres.31.2065. **PMID:** 19098379 **Citation:** Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, Jones DW, Kurtz T, Sheps SG, Roccella EJ; Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Recommendations for blood pressure measurement in humans and experimental animals: Part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Hypertension. 2005 Jan;45(1):142-61. doi: 10.1161/01.HYP.0000150859.47929.8e. Epub 2004 Dec 20. **PMID:** 15611362 **Citation:** Millar-Craig MW, Bishop CN, Raftery EB. Circadian variation of blood-pressure. Lancet. 1978 Apr 15;1(8068):795-7. doi: 10.1016/s0140-6736(78)92998-7. **PMID:** 85815 **Citation:** Parati G, Stergiou G, O'Brien E, Asmar R, Beilin L, Bilo G, Clement D, de la Sierra A, de Leeuw P, Dolan E, Fagard R, Graves J, Head GA, Imai Y, Kario K, Lurbe E, Mallion JM, Mancia G, Mengden T, Myers M, Ogedegbe G, Ohkubo T, Omboni S, Palatini P, Redon J, Ruilope LM, Shennan A, Staessen JA, vanMontfrans G, Verdecchia P, Waeber B, Wang J, Zanchetti A, Zhang Y; European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability. European Society of Hypertension practice guidelines for ambulatory blood pressure monitoring. J Hypertens. 2014 Jul;32(7):1359-66. doi: 10.1097/HJH.0000000000000221. **PMID:** 24886823 **Citation:** Verdecchia P, Angeli F, Mazzotta G, Garofoli M, Ramundo E, Gentile G, Ambrosio G, Reboldi G. Day-night dip and early-morning surge in blood pressure in hypertension: prognostic implications. Hypertension. 2012 Jul;60(1):34-42. doi: 10.1161/HYPERTENSIONAHA.112.191858. Epub 2012 May 14. **PMID:** 22585951 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000001145 - Term: Arrhythmias, Cardiac - ID: D000006331 - Term: Heart Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10024 - Name: Hypertension - Relevance: HIGH - As Found: Hypertension - ID: M4586 - Name: Atrial Fibrillation - Relevance: HIGH - As Found: Atrial Fibrillation - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M4453 - Name: Arrhythmias, Cardiac - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006973 - Term: Hypertension - ID: D000001281 - Term: Atrial Fibrillation ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04825379 **Brief Title:** Clinical Evaluation of a Bioactive Material **Official Title:** Clinical Evaluation of a Bioactive Material #### Organization Study ID Info **ID:** bioactive-composite #### Organization **Class:** OTHER **Full Name:** Hacettepe University ### Status Module #### Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-10-03 **Type:** ACTUAL **Last Update Submit Date:** 2023-10-02 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2021-09-01 **Type:** ACTUAL #### Start Date **Date:** 2021-06-01 **Type:** ACTUAL **Status Verified Date:** 2023-10 #### Study First Post Date **Date:** 2021-04-01 **Type:** ACTUAL **Study First Submit Date:** 2021-03-28 **Study First Submit QC Date:** 2021-03-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hacettepe University #### Responsible Party **Investigator Affiliation:** Hacettepe University **Investigator Full Name:** Dr. Fatma Dilşad Öz **Investigator Title:** Assoc. Prof. Dr. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The clinical performance of a bioactive composite and a posterior resin composite in class II restorations will be evaluated and compared. After recruiting participants with at least 2 approximal caries lesions, all restorations will be placed by a single clinician. All caries lesions will be removed before restoring. Cavities will be divided into two groups: a bioactive composite \[Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN)\] and a posterior resin composite \[G-ænial Posterior (GC, Tokyo, Japan) (GP)\] All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using FDI criteria after a week (baseline) 6, 12, 24, 36 and 48 months. Descriptive statistics will be performed using chi-square tests. ### Conditions Module **Conditions:** - Tooth Disease ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 31 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN) **Intervention Names:** - Device: bioactive composite **Label:** bioactive composite **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** G-ænial Posterior (GC, Tokyo, Japan) (GP) **Intervention Names:** - Device: posterior composite **Label:** posterior resin composite **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - bioactive composite **Description:** Cention N **Name:** bioactive composite **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - posterior resin composite **Description:** G-ænial Posterior **Name:** posterior composite **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Two year results according to FDI criteria **Measure:** Clinical performances of different restorative systems according to FDI criteria **Time Frame:** two years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * age range will be 18 to 65 * patients should have at least 2 approximal caries lesions require restoration * healthy periodontal status * a good likelihood of recall availability Exclusion Criteria: * poor gingival health * adverse medical history * potential behavioral problems **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Ankara **Country:** Turkey **Facility:** Hacettepe University ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M16831 - Name: Tooth Diseases - Relevance: HIGH - As Found: Tooth Disease - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014076 - Term: Tooth Diseases ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04417179 **Brief Title:** Erector Spinae Block Versus Transversus Abdominis Plane Block In Laparoscopic Bariatric Surgery **Official Title:** The Feasibility and Efficacy of Erector Spinae Block Versus Transversus Abdominis Plane Block In Laparoscopic Bariatric Surgery #### Organization Study ID Info **ID:** MD-250-2020 #### Organization **Class:** OTHER **Full Name:** Cairo University ### Status Module #### Completion Date **Date:** 2022-02-20 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-03-18 **Type:** ACTUAL **Last Update Submit Date:** 2022-03-17 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-02-01 **Type:** ACTUAL #### Start Date **Date:** 2020-08-20 **Type:** ACTUAL **Status Verified Date:** 2022-03 #### Study First Post Date **Date:** 2020-06-04 **Type:** ACTUAL **Study First Submit Date:** 2020-05-31 **Study First Submit QC Date:** 2020-06-03 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cairo University #### Responsible Party **Investigator Affiliation:** Cairo University **Investigator Full Name:** mohamed abdelghany ali **Investigator Title:** Anesthesia lecturer **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study to compare erector spinae block to transversus abdominis plane block in bariatric surgeries regarding analgesic efficacy and postoperative oxygenation and respiratory complications **Detailed Description:** The erector spinae plane (ESP) block is an interfascial block proposed to provide analgesia for chronic pain and perioperative period. it can provide both visceral and somatic abdominal analgesia if the injection were performed at a lower thoracic level. ESP block is effective, easy to perform, and can be performed in a short time. Therefore, bilateral ESP block may have comparable or improved analgesic effect in upper and lower abdominal surgical procedures when compared to other suitable plane blocks. Transversus abdominis plane (TAP) block technique is to reduce postoperative pain and is a part of current analgesic regimen for many abdominal surgeries . Moreover, it was found that posterior TAP block appears to produce more prolonged analgesia than the lateral TAP block. Ultrasound guided TAP block is a feasible, minimally invasive technique . It reduces the postoperative requirement of opioid analgesics, decreases the incidence and severity of postoperative nausea and vomiting, improves patient satisfaction, and allows early readiness for discharge postoperatively. Both blocks is effective in reducing postoperative complication and need of analgesia , To our knowledge there is no comparative study between the two blocks to this population . the investigators aim to compare the perioperative analgesic effect between TAP block and ES block in bariatric . ### Conditions Module **Conditions:** - Erector Spinae Block - Bariatric Surgery Candidate ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 60 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** the TAP block will be given by a high frequency linear ultrasound transducer of Siemens acuson x300 3-5MHz ultrasound . a blunted tip , 20-gauge, short bevel needle (Pajunk Sonoplex, Geisingen, Germany) will be used under direct ultrasound visualization, . After confirming the correct placement of the needle and the negative aspiration probe anaesthetic substance will be injected along the subcostal line in the transversus abdominis plane 20 ml 0.25% bupivacaine(10) , and the dissection of the plane was observed. The block will be performed bilaterally. **Intervention Names:** - Procedure: transversus abdominis block - Drug: Bupivacaine 0.25% Injectable Solution - Device: Siemens Acuson x300 3-5MHz Ultrasound **Label:** TAP block group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** the Erector Spinae block will be given by a high-frequency linear ultrasound transducer of Siemens acuson x300 3-5MHz ultrasound .A blunted tip , 20-gauge, short bevel needle (Pajunk Sonoplex, Geisingen, Germany) will be used under strict aseptic precautions until the tip is deep to erector spinae muscle, The block will be performed bilaterally by injecting 40 mL of 0.25% bupivacaine (20 mL into each side) into the fascial plane between the deep surface of the Erector Spinae muscle and the transverse processes of the lumbar vertebrae laterally **Intervention Names:** - Procedure: Erector spinae block - Drug: Bupivacaine 0.25% Injectable Solution - Device: Siemens Acuson x300 3-5MHz Ultrasound **Label:** ESP group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - TAP block group **Description:** transversus abdominis block **Name:** transversus abdominis block **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - ESP group **Description:** Erector spinae block **Name:** Erector spinae block **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - ESP group - TAP block group **Description:** Local Anesthetic used in both blocks **Name:** Bupivacaine 0.25% Injectable Solution **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - ESP group - TAP block group **Description:** Ultrasound used to aid in the blocks **Name:** Siemens Acuson x300 3-5MHz Ultrasound **Type:** DEVICE ### Outcomes Module #### Other Outcomes **Description:** Time taken to perform a successful block **Measure:** feasibility of block **Time Frame:** preoperative **Description:** Time to ambulate in both groups **Measure:** ambulation **Time Frame:** 24 hour **Description:** p/f ratio after first 12 , 24 hours postoperatively in both groups **Measure:** arterial oxygen tension to fraction of inspired oxygen ratio **Time Frame:** 12, 24 hours postoperative **Description:** Incidence of postoperative pulmonary complication ( chest x-ray at 12, 24 hr postoperative ) **Measure:** pulmonary complications **Time Frame:** 12,24 hours postoperative #### Primary Outcomes **Description:** The analgesic efficacy of erector spinae block versus TAP block assessed by visual analogue score(range from 1 denoted the least pain to 10 as the worst pain) in 24hr in laparoscopic bariatric surgery. **Measure:** efficacy of block **Time Frame:** first 24 hours postoperative #### Secondary Outcomes **Description:** Failure rate in both groups **Measure:** failure rate **Time Frame:** first hour postoperatively ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patient age \>18 \<60 * Obese patients ; Body mass index(BMI) 40-50 kg/m2 * Both sexes * American Society of Anesthesiologists(ASA) physical status classes II and III * Patients scheduled for laparoscopic bariatric surgery i.e. sleeve gastrectomy and/or Roux-en-Y gastric bypass (RYGB)surgeries Exclusion Criteria: * Refusal of regional block * Patients with neurological, psychological disorders or those lacking cooperation * Patients scheduled for concomitant laparoscopic cholecystectomy or paraumbilical hernia repair or those with history of previous bariatric surgery or obstructive sleep apnea * Patients with anatomic abnormalities at site of injection, skin lesions or wounds at site of proposed needle insertion. * Patients with bleeding disorders defined as (INR \>2) and/ or (platelet count \<100,000/µL) * Patients with hepatic disease e.g. liver cell failure or hepatic malignancy or hepatic enlargement. * Patients who are allergic to amide local anesthetics. * Cases converted to open surgery will also be excluded from the study **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Faculty of Medicine **Zip:** 11562 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Tulgar S, Selvi O, Kapakli MS. Erector Spinae Plane Block for Different Laparoscopic Abdominal Surgeries: Case Series. Case Rep Anesthesiol. 2018 Feb 18;2018:3947281. doi: 10.1155/2018/3947281. eCollection 2018. **PMID:** 29670771 **Citation:** Abdallah FW, Laffey JG, Halpern SH, Brull R. Duration of analgesic effectiveness after the posterior and lateral transversus abdominis plane block techniques for transverse lower abdominal incisions: a meta-analysis. Br J Anaesth. 2013 Nov;111(5):721-35. doi: 10.1093/bja/aet214. Epub 2013 Jun 27. **PMID:** 23811424 **Citation:** Mittal T, Dey A, Siddhartha R, Nali A, Sharma B, Malik V. Efficacy of ultrasound-guided transversus abdominis plane (TAP) block for postoperative analgesia in laparoscopic gastric sleeve resection: a randomized single blinded case control study. Surg Endosc. 2018 Dec;32(12):4985-4989. doi: 10.1007/s00464-018-6261-6. Epub 2018 Jun 4. **PMID:** 29869078 ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000000779 - Term: Anesthetics, Local - ID: D000000777 - Term: Anesthetics - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PhSol - Name: Pharmaceutical Solutions ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M5315 - Name: Bupivacaine - Relevance: HIGH - As Found: Following - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000002045 - Term: Bupivacaine ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05960279 **Acronym:** MINT **Brief Title:** Microwave Imaging in NeuroTrauma **Official Title:** Microwave Imaging in NeuroTrauma (MINT) - a Feasibility Study Investigating Whether Microwave-based Scanning Technology Can Detect an Intra-cranial Bleed in Adult Head Injury Patients #### Organization Study ID Info **ID:** 223018 #### Organization **Class:** OTHER **Full Name:** King's College Hospital NHS Trust ### Status Module #### Completion Date **Date:** 2025-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-07-25 **Type:** ACTUAL **Last Update Submit Date:** 2023-07-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-01 **Type:** ESTIMATED #### Start Date **Date:** 2021-07-20 **Type:** ACTUAL **Status Verified Date:** 2023-07 #### Study First Post Date **Date:** 2023-07-25 **Type:** ACTUAL **Study First Submit Date:** 2023-07-12 **Study First Submit QC Date:** 2023-07-21 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Air Ambulance Charity Kent, Surrey, Sussex **Class:** OTHER **Name:** St George's University Hospitals NHS Foundation Trust **Class:** UNKNOWN **Name:** Medfield Diagnostics AB #### Lead Sponsor **Class:** OTHER **Name:** King's College Hospital NHS Trust #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The study aims to investigate whether microwave-based technology can be used as a bedside decision-making aid to identify patients who may have a bleed in their head. The MD100 is a microwave-based head scanner, developed for the purpose of detecting strokes. In clinical trials, it was noticed that the device performed better when the patient suffered a stroke due to a bleed. It was believed that this device had wider applications in trauma care. The MD100 has demonstrated a very high level of accuracy in detecting bleeds in small clinical trials in the non-acute setting. The device is supported by software that determines the presence of a bleed. This study will be set in the emergency department of major trauma centres. Patients that have sustained a head injury will be considered for enrollment into the study. Following a head CT scan, patients will be scanned by the MD100. The trial will run in two phases. In phase one: the findings from the patient's head CT scan will be used to trial the device and teach the software what it is scanning. In phase two: The MD100 will be tested to see whether it can concur with the findings of the patient's CT scan, this will be used to determine the accuracy and reliability of the device. ### Conditions Module **Conditions:** - Craniocerebral Trauma **Keywords:** - Head injury - Traumatic brain injury ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The head CT findings from this patient group will be used to teach the MD100 how to interpret its scan of the patients. **Intervention Names:** - Device: MD100 **Label:** Training group #### Arm Group 2 **Description:** Once sufficient training data has been obtained, subsequent head CT findings from patients enrolled into the study will be used to test the accuracy of the MD100 **Intervention Names:** - Device: MD100 **Label:** Testing group ### Interventions #### Intervention 1 **Arm Group Labels:** - Testing group - Training group **Description:** The MD100 (Medfield Diagnostics, Gothenburg, Sweden) consists of 8 antennas and measurement electronics integrated into a single device; rechargeable ion batteries power the instrument. The radiation transmitted from the device equals approximately 1% of the radiation emitted from a mobile phone. The device is non-invasive and small enough that it can be moved around with ease. The system transmits microwaves with an output of 0.2 milliWatts (mW) for less than 90 seconds. The power absorbed by the body is 100mW/kg which is a factor of 200 less than what is established by the existing safety standard for microwaves. A mobile phone output, by comparison, can be up to 250mW. The patient's head is placed in the instrument during measurement while the patient is supine. The procedure takes, on average, 5 minutes to perform. **Name:** MD100 **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The MD100's proportion of true positives of intracranial bleeds detected in the head injured patient. **Measure:** Accuracy of the MD100 **Time Frame:** One year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients 18 and over. * Blunt head trauma * The patient has had a CT head scan Exclusion Criteria: * Patients with head injuries penetrating the skull * Patients with radiologically confirmed cervical spine fracture * Patients with radiologically confirmed depressed skull fracture and/or dislocation * Patients with implanted metal in or around their skull (including titanium places and surgical staples) * Confirmed pregnancy * Per the investigator's judgement, any condition or symptoms preventing the patient from entering the trial. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Head injury patients presenting to the emergency department ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jack Barrett, BSc **Phone:** 07871632555 **Role:** CONTACT #### Locations **Location 1:** **City:** London **Contacts:** ***Contact 1:*** - **Name:** Malcolm Tunnicliff, MBBS - **Role:** CONTACT **Country:** United Kingdom **Facility:** King's College Hospital NHS FT **Status:** RECRUITING **Location 2:** **City:** London **Contacts:** ***Contact 1:*** - **Name:** Phil Moss - **Role:** CONTACT **Country:** United Kingdom **Facility:** St George's Hospital NHS FT **Status:** NOT_YET_RECRUITING #### Overall Officials **Official 1:** **Affiliation:** King's College Hospital NHS Trust **Name:** Malcom Tunnicliff, MBBS **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020196 - Term: Trauma, Nervous System - ID: D000009422 - Term: Nervous System Diseases - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BC14 - Name: Heart and Blood Diseases ### Condition Browse Module - Browse Leaves - ID: M9556 - Name: Hemorrhage - Relevance: LOW - As Found: Unknown - ID: M5207 - Name: Brain Injuries - Relevance: LOW - As Found: Unknown - ID: M628 - Name: Brain Injuries, Traumatic - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M22113 - Name: Intracranial Hemorrhages - Relevance: LOW - As Found: Unknown - ID: M9349 - Name: Craniocerebral Trauma - Relevance: HIGH - As Found: Craniocerebral Trauma - ID: M22023 - Name: Trauma, Nervous System - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006259 - Term: Craniocerebral Trauma ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02580279 **Brief Title:** Study of Epigallocatechin-3-gallate (EGCG) for Skin Prevention in Patients With Breast Cancer Receiving Adjuvant Radiotherapy **Official Title:** Phase II Study of Topical Epigallocatechin-3-gallate (EGCG) in Patients With Breast Cancer Receiving Adjuvant Radiotherapy #### Organization Study ID Info **ID:** GTEBC-2015 #### Organization **Class:** OTHER **Full Name:** Shandong Cancer Hospital and Institute ### Status Module #### Completion Date **Date:** 2019-10 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** ENROLLING_BY_INVITATION #### Last Update Post Date **Date:** 2019-04-05 **Type:** ACTUAL **Last Update Submit Date:** 2019-04-03 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2019-08 **Type:** ESTIMATED #### Start Date **Date:** 2014-12 **Status Verified Date:** 2019-04 #### Study First Post Date **Date:** 2015-10-20 **Type:** ESTIMATED **Study First Submit Date:** 2015-09-27 **Study First Submit QC Date:** 2015-10-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Shandong Cancer Hospital and Institute #### Responsible Party **Investigator Affiliation:** Shandong Cancer Hospital and Institute **Investigator Full Name:** Han Xi Zhao **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The investigators conduct this phase II study of EGCG therapy protection of the skin from damage induced by radiotherapy in breast cancer. In order to observe the effectiveness of EGCG, investigators will utilize both clinician assessments and patient self-assessments. Physician's skin assessments will be scored utilizing the Radiation Therapy Oncology Group (RTOG) score. Patient reported symptom scores are adapted from the Skin Toxicity Assessment Tool (STAT) as pain, burning, itching, pulling, and tenderness in the treatment area. The scales are translated into Chinese and guides in Chinese are developed instructing how to use the scales and perform the assessments. ### Conditions Module **Conditions:** - Breast Neoplasms - Dermatitis - Prevention & Control - Epigallocatechin Gallate **Keywords:** - Breast Neoplasms - prevention & control - Epigallocatechin gallate - Dermatitis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 68 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** EGCG (purity≥95% by high pressure liquid chromatography; from Ningbo HEP Biotech Co., Ltd) is dissolved in 0.9% saline solution;The solution is sprayed three times a day at 0.05 ml/cm2 to the whole radiation field until two weeks after radiation completion; Patients who developed grade Ⅱ radiation-induced dermatitis have the option to either withdraw from the study or to continue with EGCG. Patients are follow general good skin care practices during radiation therapy, such as not applying water soaks to relieve itching or pain, not vigorously rubbing the irradiated area, or not erasing ink marks; patting the skin dry with a soft towel; avoiding exposure to the sun; and wearing loose and cotton clothes. They are advised not to use deodorant, lotion, cream, make up, perfume or any other product on the area during the course of radiation therapy. **Intervention Names:** - Drug: EGCG **Label:** EGCG group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The placebo is 0.9% saline solution.Patients are also to follow general good skin care practices which is same as the EGCG group. **Intervention Names:** - Drug: placebo **Label:** placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - EGCG group **Name:** EGCG **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - placebo **Name:** placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Superiority of EGCG in reducing Grade II or more dermatitis as assessed by Radiation Therapy Oncology Group (RTOG) scores in patients with breast cancer receiving radiation **Time Frame:** Each patient will be enrolled for a 5-6 week trial #### Secondary Outcomes **Measure:** Superiority of EGCG in reducing pain as assessed by the Skin Toxicity Assessment Tool (STAT) in patients with breast cancer receiving radiation **Time Frame:** Each patient will be enrolled for a 5-6 week trial **Description:** questionnaire **Measure:** Improved quality of life with usage of EGCG for treatment of radiation-dermatitis in patient with breast cancer **Time Frame:** Each patient will be enrolled for a 5-6 week trial ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥ eighteen years * Eastern Cooperative Oncology Group performance status of 0-1 * Normal hematologic, hepatic function and renal values * Forced expiratory volume 1 \>800 cc Exclusion Criteria: * The presence of rash or unhealed wound in the radiation field * A known allergy or hypersensitivity to EGCG * Pregnancy or lactation * History of/current connective tissue disorder * Prior radiation to the thorax **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Shandong Cancer Hospital and Institute **Name:** Ligang Xing, MD,PhD **Role:** STUDY_CHAIR ### References Module #### References **Citation:** Zhao H, Zhu W, Zhao X, Li X, Zhou Z, Zheng M, Meng X, Kong L, Zhang S, He D, Xing L, Yu J. Efficacy of Epigallocatechin-3-Gallate in Preventing Dermatitis in Patients With Breast Cancer Receiving Postoperative Radiotherapy: A Double-Blind, Placebo-Controlled, Phase 2 Randomized Clinical Trial. JAMA Dermatol. 2022 Jul 1;158(7):779-786. doi: 10.1001/jamadermatol.2022.1736. **PMID:** 35648426 ## Annotation Section ### Unposted Annotation #### Event: RELEASE - Date: 2022-03-14 - Date Unknown: Unknown #### Event: RESET - Date: 2022-07-12 - Date Unknown: Unknown ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009369 - Term: Neoplasms - ID: D000012871 - Term: Skin Diseases - ID: D000009371 - Term: Neoplasms by Site - ID: D000001941 - Term: Breast Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Neoplasms - ID: M7067 - Name: Dermatitis - Relevance: HIGH - As Found: Dermatitis - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms - ID: D000003872 - Term: Dermatitis ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: NeuroAg - Name: Neuroprotective Agents - Abbrev: Fl - Name: Flavonoid ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M159487 - Name: Epigallocatechin gallate - Relevance: LOW - As Found: Unknown - ID: T27 - Name: Epigallocatechin - Relevance: LOW - As Found: Unknown ### Misc Info Module #### Submission Tracking - Estimated Results First Submit Date: 2022-03-14 ##### Submission Infos - MCP Release N: Unknown - Release Date: 2022-03-14 - Reset Date: 2022-07-12 - Unrelease Date: Unknown - Unrelease Date Unknown: Unknown - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04769479 **Brief Title:** A Single Dose Study to Evaluate the Pharmacokinetics of Acoramidis Modified Release Formulations in Healthy Subjects **Official Title:** A Single Dose Study to Evaluate the Pharmacokinetics of Acoramidis Modified Release Tablet Formulations in Healthy Subjects #### Organization Study ID Info **ID:** AG10-006 #### Organization **Class:** INDUSTRY **Full Name:** Eidos Therapeutics, a BridgeBio company ### Status Module #### Completion Date **Date:** 2021-09-03 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-03-23 **Type:** ACTUAL **Last Update Submit Date:** 2022-03-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-08-04 **Type:** ACTUAL #### Start Date **Date:** 2021-03-28 **Type:** ACTUAL **Status Verified Date:** 2022-03 #### Study First Post Date **Date:** 2021-02-24 **Type:** ACTUAL **Study First Submit Date:** 2021-02-19 **Study First Submit QC Date:** 2021-02-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Eidos Therapeutics, a BridgeBio company #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** True ### Description Module **Brief Summary:** This is a single centre, open-label, 5-period study in healthy male and non-pregnant and non-lactating healthy female subjects. **Detailed Description:** It is planned to enroll 14 subjects who will receive single oral doses of active IMP in a sequential manner over 5 periods, with a minimum of 7days between dosing in each period. ### Conditions Module **Conditions:** - Amyloidosis ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 14 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: acoramidis **Label:** acoramidis **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - acoramidis **Description:** acoramidis **Name:** acoramidis **Other Names:** - AG10 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Maximum Concentration (Cmax) **Measure:** Pharmacokinetic Assessments: Cmax **Time Frame:** 72 hours **Description:** Area under the plasma concentration-time curve (AUC) **Measure:** Pharmacokinetic Assessments: AUC **Time Frame:** 72 hours **Description:** Time to maximum concentration (Tmax) **Measure:** Pharmacokinetic Assessments: Tmax **Time Frame:** 72 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy males or non-pregnant, non-lactating healthy females * Body mass index (BMI) of 18.0 to 32.0kg/m² and a body weight\>50kg as measured at screening * Must be willing and able to communicate and participate in the whole study * Must provide written informed consent * Must agree to adhere to the contraception requirements Exclusion Criteria: * Subjects who have received any IMP formulation in a clinical research study within the 90 days prior to Period 1, Day 1 * History of any drug or alcohol abuse in the past 2 years * Subjects with pregnant or lactating partners * Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert's Syndrome are allowed. * History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator * Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active * Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4g of paracetamol per day or HRT/hormonal contraception) in the 14 days before first IMP administration. **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Ruddington **Country:** United Kingdom **Facility:** Quotient Sciences **State:** Nottingham **Zip:** NG11 6JS #### Overall Officials **Official 1:** **Affiliation:** Quotient Sciences **Name:** Philip Evans, MBChB, MRCS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000057165 - Term: Proteostasis Deficiencies - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4021 - Name: Amyloidosis - Relevance: HIGH - As Found: Amyloidosis - ID: M28747 - Name: Proteostasis Deficiencies - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000686 - Term: Amyloidosis ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01076179 **Acronym:** PROTEKT **Brief Title:** Kaletra in Combination With Antiretroviral Agents **Official Title:** KALETRA in Combination With New Substances (PROTEKT) #### Organization Study ID Info **ID:** P11-021 #### Organization **Class:** INDUSTRY **Full Name:** AbbVie ### Status Module #### Completion Date **Date:** 2016-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-05-19 **Type:** ACTUAL **Last Update Submit Date:** 2017-05-18 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2016-01 **Type:** ACTUAL #### Results First Post Date **Date:** 2017-05-19 **Type:** ACTUAL **Results First Submit Date:** 2017-01-18 **Results First Submit QC Date:** 2017-05-18 #### Start Date **Date:** 2008-09 **Status Verified Date:** 2017-05 #### Study First Post Date **Date:** 2010-02-26 **Type:** ESTIMATED **Study First Submit Date:** 2010-02-24 **Study First Submit QC Date:** 2010-02-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** AbbVie (prior sponsor, Abbott) #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to investigate the tolerability of Kaletra (lopinavir/ritonavir) in combination with new substances such as integrase inhibitors (INIs), C-C chemokine receptor type 5 (CCR5) antagonists, and new non-nucleoside reverse transcriptase inhibitors (NNRTIs), as there are many reasons (intolerability, complex resistant patterns or even personal reasons) which may result in a change from the daily clinical routine and lead to the use of a newly approved antiretroviral agent in combination with Kaletra. **Detailed Description:** This study was designed as a non-interventional observational study. Kaletra was prescribed in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. ### Conditions Module **Conditions:** - Human Immunodeficiency Virus **Keywords:** - Infection - Rilpivirine - CCR5 antagonists - Etravirine - Human Immunodeficiency Virus - Maraviroc - Safety and efficacy - Non nucleoside reverse transcriptase inhibitors (NNRTIs) - Integrase inhibitors - Raltegravir - Kaletra ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 502 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists **Label:** Human Immunodeficiency Virus (HIV)-Infected Participants ### Outcomes Module #### Other Outcomes **Description:** Changes in participants' HIV-1 RNA viral load were assessed by measuring the change from Baseline at scheduled visits planned as part of routine care. **Measure:** Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load **Time Frame:** Baseline (Week 0) to Week 144 **Description:** Time to virologic failure was defined by the earliest occurrence of: 1. HIV-1 RNA \> 400 copies/mL confirmed on 2 consecutive occasions after achieving at least 1 HIV-1 RNA \< 50 copies/mL, 2. HIV-1 RNA \> 400 copies/mL at the final on-study visit if the participant had previously experienced at least 1 HIV-1 RNA \< 50 copies/mL but subsequently did not have HIV-1 RNA \> 400 copies/mL on 2 consecutive occasions, or 3. Day 1 if the participant never achieved HIV-1 RNA \< 50 copies/mL during study participation. A participant who prematurely discontinued study drug with HIV-1 RNA \< 50 copies/mL was censored from analysis at the time of discontinuation provided that he/she did not previously experience either (a), (b) or (c). **Measure:** Time to Virologic Failure **Time Frame:** Baseline (Week 0) to Week 144 #### Primary Outcomes **Description:** Percentage of overall number of adverse events experienced during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the electronic case report form (eCRF). The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low high density lipoprotein (HDL) cholesterol, high low density lipoprotein (LDL) cholesterol, hyperglycemia, hyperbilirubinemia, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated gamma glutamyl transferase (γGT), elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, headache, fatigue, fever, other (listed as 'not specified'). **Measure:** Prevalence of Adverse Events (Weeks 0-144), Per Event **Time Frame:** Weeks 0 to 144 **Description:** Percentage of participants who experienced at least 1 adverse event during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the eCRF. The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low HDL cholesterol, high LDL cholesterol, hyperglycemia, hyperbilirubinemia, elevated AST, elevated ALT, elevated γGT, elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, headache, fatigue, fever, other (listed as 'not specified'). **Measure:** Prevalence of Adverse Events (Weeks 0-144), Per Participant **Time Frame:** Weeks 0 to 144 #### Secondary Outcomes **Description:** Changes in participants' CD4 cell counts were assessed by measuring the change from Baseline in the number of CD4 cells at scheduled visits planned as part of routine care. **Measure:** Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count **Time Frame:** Baseline (Week 0) to Week 144 **Description:** Changes in participants' CD4 cell counts were assessed by measuring the number of CD4 cells at scheduled visits planned as part of routine care. **Measure:** Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis **Time Frame:** Baseline (Week 0) to Week 144 **Description:** Changes in participants' CD4 cell counts were assessed by measuring the number of CD4 cells at scheduled visits planned as part of routine care. **Measure:** Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis **Time Frame:** Baseline (Week 0) to Week 144 **Measure:** Time to CD4 Cell Count Increase From Baseline of ≥ 100/ Cells/μL **Time Frame:** From Week 0 to Week 144 **Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-Genotypic Resistance-Algorithm Deutschland (GRADE; available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected. **Measure:** Number of Participants With Lopinavir (LPV) Resistance at Baseline **Time Frame:** Baseline (Week 0) **Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected. **Measure:** Number of Participants With LPV Resistance During Follow-Up **Time Frame:** up to Week 144 **Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-Genotypic Resistance-Algorithm Deutschland (GRADE; available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected. **Measure:** Number of Participants With Protease Inhibitor (PI) Resistance at Baseline **Time Frame:** Baseline (Week 0) **Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected. **Measure:** Number of Participants With PI Resistance During Follow-Up **Time Frame:** Up to Week 144 **Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected. **Measure:** Number of Participants With INI Resistance at Baseline **Time Frame:** Baseline (Week 0) **Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected. **Measure:** Number of Participants With INI Resistance During Follow-Up **Time Frame:** up to Week 144 **Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected. **Measure:** Number of Participants With NNRTI Resistance at Baseline **Time Frame:** Baseline (Week 0) **Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected. **Measure:** Number of Participants With NNRTI Resistance During Follow-Up **Time Frame:** up to Week 144 **Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected. **Measure:** Number of Participants With Nucleoside Analog Reverse-Transcriptase Inhibitor (NRTI) Resistance at Baseline **Time Frame:** Baseline (Week 0) **Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected. **Measure:** Number of Participants With NRTI Resistance During Follow-Up **Time Frame:** up to Week 144 **Description:** Participants with CCR5 tropic virus, CXC motif chemokine receptor 4 (CRCX4) tropic virus, or dual/mixed tropic virus at Baseline. **Measure:** Number of Participants With HIV-1 Coreceptor Tropism at Baseline **Time Frame:** Baseline (Week 0) **Description:** Participants with CCR5 tropic virus, CXC motif chemokine receptor 4 (CRCX4) tropic virus, or dual/mixed tropic virus at Follow-up. **Measure:** Number of Participants With HIV-1 Coreceptor Tropism During Follow-up **Time Frame:** up to Week 144 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients ≥ 18years of age * Written informed consent (authorization to the investigator to use and/or disclose personal and/or health data before entry into the KALETRA® post marketing observational study) * HIV-1 infection * Patients treated with KALETRA®, independent from their participation in this study * Patients treated with novel antiretroviral therapy (for at least 8 weeks according to the study amendment), independent from their participation in this study Exclusion Criteria: * Hypersensitivity against Kaletra or other ingredients or INIs or NNRTIs or CCR5 antagonists * Severe liver insufficiency * No concommitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and/or St. John's wort **Maximum Age:** 99 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Community sample: HIV-positive patients ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** AbbVie Deutschland GmbH & Co. KG, Medical Department **Name:** Bianca Wittig, MD **Role:** STUDY_DIRECTOR ### References Module #### See Also Links **Label:** Related Info **URL:** http://rxabbvie.com ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007154 - Term: Immune System Diseases - ID: D000086982 - Term: Blood-Borne Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000007239 - Term: Infections - ID: D000015229 - Term: Sexually Transmitted Diseases, Viral - ID: D000012749 - Term: Sexually Transmitted Diseases - ID: D000016180 - Term: Lentivirus Infections - ID: D000012192 - Term: Retroviridae Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000014777 - Term: Virus Diseases - ID: D000012897 - Term: Slow Virus Diseases - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M3522 - Name: Acquired Immunodeficiency Syndrome - Relevance: HIGH - As Found: Human Immunodeficiency Virus - ID: M18250 - Name: HIV Infections - Relevance: HIGH - As Found: Human Immunodeficiency Virus - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M10199 - Name: Immunologic Deficiency Syndromes - Relevance: HIGH - As Found: Immunodeficiency - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M2593 - Name: Blood-Borne Infections - Relevance: LOW - As Found: Unknown - ID: M15558 - Name: Sexually Transmitted Diseases - Relevance: LOW - As Found: Unknown - ID: M17933 - Name: Sexually Transmitted Diseases, Viral - Relevance: LOW - As Found: Unknown - ID: M18640 - Name: Lentivirus Infections - Relevance: LOW - As Found: Unknown - ID: M15026 - Name: Retroviridae Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M15700 - Name: Slow Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000163 - Term: Acquired Immunodeficiency Syndrome - ID: D000015658 - Term: HIV Infections - ID: D000007153 - Term: Immunologic Deficiency Syndromes ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M295 - Name: Rilpivirine - Relevance: LOW - As Found: Unknown - ID: M20935 - Name: Reverse Transcriptase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M25428 - Name: Anti-Retroviral Agents - Relevance: LOW - As Found: Unknown - ID: M1852 - Name: Maraviroc - Relevance: LOW - As Found: Unknown - ID: M333 - Name: Raltegravir Potassium - Relevance: LOW - As Found: Unknown - ID: M21386 - Name: Integrase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M339955 - Name: Etravirine - Relevance: LOW - As Found: Unknown - ID: M21385 - Name: HIV Integrase Inhibitors - Relevance: LOW - As Found: Unknown ### Misc Info Module #### Removed Countries - Country: Germany - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module **Description:** Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data. #### Event Groups **Group ID:** EG000 **Title:** HIV-infected Participants **Description:** HIV-infected participants on Kaletra and integrase inhibitors or non nucleoside reverse transcriptase inhibitors or CCR5 antagonists **ID:** EG000 **Serious Number Affected:** 30 **Serious Number At Risk:** 501 **Title:** HIV-infected Participants **Frequency Threshold:** 0 #### Serious Events **Term:** LYMPHADENOPATHY **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 501 **Term:** NEUTROPENIA **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** CARDIAC FAILURE **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** ABDOMINAL PAIN **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** DIARRHOEA **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 501 **Term:** NAUSEA **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** STOMATITIS **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** VOMITING **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** ASTHENIA **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** FATIGUE **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** MULTI-ORGAN FAILURE **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 501 **Term:** OEDEMA PERIPHERAL **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** PYREXIA **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** HYPERBILIRUBINAEMIA **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** AIDS DEMENTIA COMPLEX **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** ACUTE HEPATITIS C **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** ANAL ABSCESS **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** CHLAMYDIAL INFECTION **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** CYTOMEGALOVIRUS INFECTION **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** INFECTION **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** INJECTION SITE ABSCESS **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** LYMPHOGRANULOMA VENEREUM **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** PNEUMOCOCCAL SEPSIS **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** PNEUMONIA **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** PNEUMONIA FUNGAL **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** SEPSIS **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** SEPTIC SHOCK **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** SUBCUTANEOUS ABSCESS **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** TUBERCULOSIS **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** YERSINIA INFECTION **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** FALL **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** RADIUS FRACTURE **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** ACTINOMYCES TEST POSITIVE **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** ALANINE AMINOTRANSFERASE INCREASED **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** ASPARTATE AMINOTRANSFERASE INCREASED **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** GAMMA-GLUTAMYLTRANSFERASE INCREASED **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 501 **Term:** INFLAMMATORY MARKER INCREASED **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** STREPTOCOCCUS TEST POSITIVE **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** TROPONIN INCREASED **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** DEHYDRATION **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** DIABETES MELLITUS **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** HYPERGLYCAEMIA **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** HYPONATRAEMIA **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 501 **Term:** METABOLIC DISORDER **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** FASCIITIS **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** FISTULA **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** INTERVERTEBRAL DISC PROTRUSION **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** BASAL CELL CARCINOMA **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** BUSCHKE-LOWENSTEIN'S TUMOUR **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** KAPOSI'S SARCOMA **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** NEUROENDOCRINE CARCINOMA **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** PANCREATIC NEOPLASM **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** ALTERED STATE OF CONSCIOUSNESS **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** CAROTID ARTERY ANEURYSM **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** CAROTID ARTERY STENOSIS **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** CAROTID ARTERY THROMBOSIS **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** CEREBROVASCULAR ACCIDENT **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** DEMENTIA **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** NERVOUS SYSTEM DISORDER **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** SEIZURE **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** SYNCOPE **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** TRANSIENT ISCHAEMIC ATTACK **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** VERTEBRAL ARTERY STENOSIS **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** WHITE MATTER LESION **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** ACUTE PSYCHOSIS **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** DELUSION **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** DEPRESSION **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** CHRONIC OBSTRUCTIVE PULMONARY DISEASE **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** COUGH **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 501 **Term:** DYSPNOEA **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** DYSPNOEA EXERTIONAL **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** INTERSTITIAL LUNG DISEASE **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** PULMONARY OEDEMA **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** SPUTUM DISCOLOURED **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** DECUBITUS ULCER **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** LIPODYSTROPHY ACQUIRED **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** ARTERIAL STENOSIS **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** ARTERIOSCLEROSIS **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** CIRCULATORY COLLAPSE **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** DEEP VEIN THROMBOSIS **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Term:** HYPERTENSIVE CRISIS **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 18.1 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 501 **Time Frame:** Up to Week 144 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 501 **Units:** Participants ### Group **ID:** BG000 **Title:** HIV-infected Participants **Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists ### Measure #### Measurement **Group ID:** BG000 **Spread:** 11.1 **Value:** 45.4 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 70 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 431 **Category Title:** Male **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ## Results Section - More Information Module ### Certain Agreement **Other Details:** AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection. **Restriction Type:** OTHER **Restrictive Agreement:** True ### Point of Contact **Organization:** AbbVie (prior sponsor Abbott) **Phone:** 800-633-9110 **Title:** Global Medical Services ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ### Outcome Measure 5 ### Outcome Measure 6 ### Outcome Measure 7 ### Outcome Measure 8 ### Outcome Measure 9 ### Outcome Measure 10 ### Outcome Measure 11 ### Outcome Measure 12 ### Outcome Measure 13 ### Outcome Measure 14 ### Outcome Measure 15 ### Outcome Measure 16 ### Outcome Measure 17 ### Outcome Measure 18 ### Outcome Measure 19 ### Outcome Measure 20 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 13.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 19.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 6.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 14.9 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 9.1 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 14.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 17.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 7.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 6.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 7.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 8.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 27.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 7.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 9.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 28.5 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 161.7 - **Upper Limit:** - **Value:** 54.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 369 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 148.5 - **Upper Limit:** - **Value:** 64.6 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 400 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 195.3 - **Upper Limit:** - **Value:** 78.8 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 414 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 214.4 - **Upper Limit:** - **Value:** 95.8 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 363 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 213.2 - **Upper Limit:** - **Value:** 107.4 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 344 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 247.7 - **Upper Limit:** - **Value:** 131.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 315 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 216.1 - **Upper Limit:** - **Value:** 125.3 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 300 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 223.9 - **Upper Limit:** - **Value:** 142.8 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 266 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 207.0 - **Upper Limit:** - **Value:** 143.3 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 265 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 219.8 - **Upper Limit:** - **Value:** 155.3 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 233 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 233.0 - **Upper Limit:** - **Value:** 170.9 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 219 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 243.3 - **Upper Limit:** - **Value:** 180.3 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 212 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 252.9 - **Upper Limit:** - **Value:** 190.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 212 **Units:** Participants #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 23.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 36.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 45.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 53.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 58.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 62.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 65.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 67.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 70.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 72.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 72.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 73.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 73.7 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 32.2 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 369 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 32.5 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 400 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 37.9 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 414 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 43.8 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 363 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 48.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 344 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 50.5 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 315 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 50.3 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 300 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 54.5 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 266 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 55.8 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 265 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 60.1 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 233 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 58.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 219 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 58.0 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 212 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 61.3 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 212 **Units:** Participants #### Outcome Measure 6 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.8 - **Upper Limit:** - **Value:** 56.1 **Title:** #### Outcome Measure 7 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 155 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4 **Title:** #### Outcome Measure 8 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** #### Outcome Measure 9 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 142 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 17 **Title:** #### Outcome Measure 10 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** #### Outcome Measure 11 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** #### Outcome Measure 12 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 **Title:** #### Outcome Measure 13 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 113 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 46 **Title:** #### Outcome Measure 14 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** #### Outcome Measure 15 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 96 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 63 **Title:** #### Outcome Measure 16 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 **Title:** #### Outcome Measure 17 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 74 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 21 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 13 **Title:** #### Outcome Measure 18 #### Outcome Measure 19 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.40 - **Upper Limit:** - **Value:** -1.37 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 389 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.63 - **Upper Limit:** - **Value:** -1.53 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 408 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.70 - **Upper Limit:** - **Value:** -1.45 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 413 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.69 - **Upper Limit:** - **Value:** -1.49 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 367 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.68 - **Upper Limit:** - **Value:** -1.46 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 347 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.62 - **Upper Limit:** - **Value:** -1.27 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 320 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.65 - **Upper Limit:** - **Value:** -1.32 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 304 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.64 - **Upper Limit:** - **Value:** -1.34 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 269 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.59 - **Upper Limit:** - **Value:** -1.36 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 265 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.67 - **Upper Limit:** - **Value:** -1.32 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 233 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.73 - **Upper Limit:** - **Value:** -1.29 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 225 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.65 - **Upper Limit:** - **Value:** -1.33 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 213 **Units:** Participants **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.68 - **Upper Limit:** - **Value:** -1.38 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 216 **Units:** Participants #### Outcome Measure 20 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 6.2 - **Upper Limit:** - **Value:** 194.4 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Percentage of overall number of adverse events experienced during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the electronic case report form (eCRF). The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low high density lipoprotein (HDL) cholesterol, high low density lipoprotein (LDL) cholesterol, hyperglycemia, hyperbilirubinemia, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated gamma glutamyl transferase (γGT), elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, headache, fatigue, fever, other (listed as 'not specified'). **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** Weeks 0 to 144 **Title:** Prevalence of Adverse Events (Weeks 0-144), Per Event **Type:** PRIMARY **Type Units Analyzed:** Adverse Events **Unit of Measure:** percentage of adverse events ##### Group **Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists **ID:** OG000 **Title:** HIV-infected Participants #### Outcome Measure 2 **Description:** Percentage of participants who experienced at least 1 adverse event during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the eCRF. The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low HDL cholesterol, high LDL cholesterol, hyperglycemia, hyperbilirubinemia, elevated AST, elevated ALT, elevated γGT, elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, headache, fatigue, fever, other (listed as 'not specified'). **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** Weeks 0 to 144 **Title:** Prevalence of Adverse Events (Weeks 0-144), Per Participant **Type:** PRIMARY **Unit of Measure:** percentage of participants ##### Group **Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists **ID:** OG000 **Title:** HIV-infected Participants #### Outcome Measure 3 **Description:** Changes in participants' CD4 cell counts were assessed by measuring the change from Baseline in the number of CD4 cells at scheduled visits planned as part of routine care. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point. **Reporting Status:** POSTED **Time Frame:** Baseline (Week 0) to Week 144 **Title:** Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count **Type:** SECONDARY **Unit of Measure:** cells/μL ##### Group **Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists **ID:** OG000 **Title:** HIV-infected Participants #### Outcome Measure 4 **Description:** Changes in participants' CD4 cell counts were assessed by measuring the number of CD4 cells at scheduled visits planned as part of routine care. **Parameter Type:** NUMBER **Population Description:** Modified 'intent-to-treat' analysis: missing values were replaced by the last observed value of that variable (last observation carried forward method). **Reporting Status:** POSTED **Time Frame:** Baseline (Week 0) to Week 144 **Title:** Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists **ID:** OG000 **Title:** HIV-infected Participants #### Outcome Measure 5 **Description:** Changes in participants' CD4 cell counts were assessed by measuring the number of CD4 cells at scheduled visits planned as part of routine care. **Parameter Type:** NUMBER **Population Description:** 'As treated' analyses: participants with an assessment, missing data excluded. Number analyzed=participants with an assessment at given time point. **Reporting Status:** POSTED **Time Frame:** Baseline (Week 0) to Week 144 **Title:** Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists **ID:** OG000 **Title:** HIV-infected Participants #### Outcome Measure 6 **Dispersion Type:** Standard Error **Parameter Type:** MEAN **Population Description:** Participants with an assessment **Reporting Status:** POSTED **Time Frame:** From Week 0 to Week 144 **Title:** Time to CD4 Cell Count Increase From Baseline of ≥ 100/ Cells/μL **Type:** SECONDARY **Unit of Measure:** weeks ##### Group **Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists **ID:** OG000 **Title:** HIV-infected Participants #### Outcome Measure 7 **Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-Genotypic Resistance-Algorithm Deutschland (GRADE; available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** Participants with an assessment at Baseline **Reporting Status:** POSTED **Time Frame:** Baseline (Week 0) **Title:** Number of Participants With Lopinavir (LPV) Resistance at Baseline **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists **ID:** OG000 **Title:** HIV-infected Participants #### Outcome Measure 8 **Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** Participants with an assessment during follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician. **Reporting Status:** POSTED **Time Frame:** up to Week 144 **Title:** Number of Participants With LPV Resistance During Follow-Up **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists **ID:** OG000 **Title:** HIV-infected Participants #### Outcome Measure 9 **Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-Genotypic Resistance-Algorithm Deutschland (GRADE; available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** Participants with an assessment at Baseline **Reporting Status:** POSTED **Time Frame:** Baseline (Week 0) **Title:** Number of Participants With Protease Inhibitor (PI) Resistance at Baseline **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists **ID:** OG000 **Title:** HIV-infected Participants #### Outcome Measure 10 **Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** Participants with an assessment during follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician. **Reporting Status:** POSTED **Time Frame:** Up to Week 144 **Title:** Number of Participants With PI Resistance During Follow-Up **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists **ID:** OG000 **Title:** HIV-infected Participants #### Outcome Measure 11 **Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** Participants with an assessment at Baseline **Reporting Status:** POSTED **Time Frame:** Baseline (Week 0) **Title:** Number of Participants With INI Resistance at Baseline **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists **ID:** OG000 **Title:** HIV-infected Participants #### Outcome Measure 12 **Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** Participants with an assessment at follow-up (neither had available Baseline testing); since this was an observational study, resistance testing was performed at the discretion of the treating physician. **Reporting Status:** POSTED **Time Frame:** up to Week 144 **Title:** Number of Participants With INI Resistance During Follow-Up **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists **ID:** OG000 **Title:** HIV-infected Participants #### Outcome Measure 13 **Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** Participants with an assessment at Baseline **Reporting Status:** POSTED **Time Frame:** Baseline (Week 0) **Title:** Number of Participants With NNRTI Resistance at Baseline **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists **ID:** OG000 **Title:** HIV-infected Participants #### Outcome Measure 14 **Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** Participants with an assessment at follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician. **Reporting Status:** POSTED **Time Frame:** up to Week 144 **Title:** Number of Participants With NNRTI Resistance During Follow-Up **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists **ID:** OG000 **Title:** HIV-infected Participants #### Outcome Measure 15 **Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** Participants with an assessment at Baseline **Reporting Status:** POSTED **Time Frame:** Baseline (Week 0) **Title:** Number of Participants With Nucleoside Analog Reverse-Transcriptase Inhibitor (NRTI) Resistance at Baseline **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists **ID:** OG000 **Title:** HIV-infected Participants #### Outcome Measure 16 **Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** Participants with an assessment at follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician. **Reporting Status:** POSTED **Time Frame:** up to Week 144 **Title:** Number of Participants With NRTI Resistance During Follow-Up **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists **ID:** OG000 **Title:** HIV-infected Participants #### Outcome Measure 17 **Description:** Participants with CCR5 tropic virus, CXC motif chemokine receptor 4 (CRCX4) tropic virus, or dual/mixed tropic virus at Baseline. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** Participants with an assessment at Baseline **Reporting Status:** POSTED **Time Frame:** Baseline (Week 0) **Title:** Number of Participants With HIV-1 Coreceptor Tropism at Baseline **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists **ID:** OG000 **Title:** HIV-infected Participants #### Outcome Measure 18 **Description:** Participants with CCR5 tropic virus, CXC motif chemokine receptor 4 (CRCX4) tropic virus, or dual/mixed tropic virus at Follow-up. **Population Description:** Since this was an observational study, resistance testing was performed at the discretion of the treating physician. No follow-up data on tropism was collected. **Reporting Status:** POSTED **Time Frame:** up to Week 144 **Title:** Number of Participants With HIV-1 Coreceptor Tropism During Follow-up **Type:** SECONDARY ##### Group **Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists **ID:** OG000 **Title:** HIV-infected Participants #### Outcome Measure 19 **Description:** Changes in participants' HIV-1 RNA viral load were assessed by measuring the change from Baseline at scheduled visits planned as part of routine care. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point. **Reporting Status:** POSTED **Time Frame:** Baseline (Week 0) to Week 144 **Title:** Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load **Type:** OTHER_PRE_SPECIFIED **Unit of Measure:** log copies/mL ##### Group **Description:** HIV-infected participants on Kaletra and integrase inhibitors or non nucleoside reverse transcriptase inhibitors or CCR5 antagonists **ID:** OG000 **Title:** HIV-infected Participants #### Outcome Measure 20 **Description:** Time to virologic failure was defined by the earliest occurrence of: 1. HIV-1 RNA \> 400 copies/mL confirmed on 2 consecutive occasions after achieving at least 1 HIV-1 RNA \< 50 copies/mL, 2. HIV-1 RNA \> 400 copies/mL at the final on-study visit if the participant had previously experienced at least 1 HIV-1 RNA \< 50 copies/mL but subsequently did not have HIV-1 RNA \> 400 copies/mL on 2 consecutive occasions, or 3. Day 1 if the participant never achieved HIV-1 RNA \< 50 copies/mL during study participation. A participant who prematurely discontinued study drug with HIV-1 RNA \< 50 copies/mL was censored from analysis at the time of discontinuation provided that he/she did not previously experience either (a), (b) or (c). **Dispersion Type:** Standard Error **Parameter Type:** MEAN **Population Description:** Participants with an assessment **Reporting Status:** POSTED **Time Frame:** Baseline (Week 0) to Week 144 **Title:** Time to Virologic Failure **Type:** OTHER_PRE_SPECIFIED **Unit of Measure:** weeks ##### Group **Description:** HIV-infected participants on Kaletra and integrase inhibitors or non nucleoside reverse transcriptase inhibitors or CCR5 antagonists **ID:** OG000 **Title:** HIV-infected Participants ### Participant Flow Module #### Group **Description:** Human immunodeficiency virus (HIV)-infected participants on Kaletra and integrase inhibitors (INIs) or non nucleoside reverse transcriptase inhibitors NNRTIs) or C-C chemokine receptor type 5 (CCR5) antagonists **ID:** FG000 **Title:** HIV-infected Participants #### Period **Title:** Overall Study ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 502 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 501 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 1 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT01103479 **Brief Title:** Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening **Official Title:** Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening #### Organization Study ID Info **ID:** R01CA140177-01 **Link:** https://reporter.nih.gov/quickSearch/R01CA140177-01 **Type:** NIH #### Organization **Class:** OTHER **Full Name:** Northwestern University #### Secondary ID Infos **ID:** R01CA140177 **Link:** https://reporter.nih.gov/quickSearch/R01CA140177 **Type:** NIH ### Status Module #### Completion Date **Date:** 2013-09 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2015-05-06 **Type:** ESTIMATED **Last Update Submit Date:** 2015-04-14 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2013-07 **Type:** ACTUAL #### Results First Post Date **Date:** 2014-09-09 **Type:** ESTIMATED **Results First Submit Date:** 2014-08-28 **Results First Submit QC Date:** 2014-08-28 #### Start Date **Date:** 2010-04 **Status Verified Date:** 2015-04 #### Study First Post Date **Date:** 2010-04-14 **Type:** ESTIMATED **Study First Submit Date:** 2010-04-12 **Study First Submit QC Date:** 2010-04-13 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Cancer Institute (NCI) #### Lead Sponsor **Class:** OTHER **Name:** Northwestern University #### Responsible Party **Investigator Affiliation:** Northwestern University **Investigator Full Name:** Kenzie Cameron **Investigator Title:** Research Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to evaluate the effectiveness of a low literacy, physician and patient-directed intervention to promote colorectal cancer (CRC) screening among the medically underserved. **Detailed Description:** This study will test the separate and combined effect of two of these interventions: 1) a provider communication skills training using a continuous quality improvement (CQI) framework, and 2) a brief, multimedia Patient Education Program (PEP) that incorporates plain language, graphic design, and audio voice-over to overcome literacy limitations. Our provider intervention has demonstrated efficacy to significantly improve CRC screening recommendation rates. Our multimedia program has also been field tested among patients with limited literacy and was able to improve patient knowledge and intention to receive screening. We will implement both provider-only and combined provider-patient strategies within a federally qualified health center network to determine the most effective and efficient approach to promote CRC screening in these settings. Results from the study, supplemented by cost analyses and the process evaluation will directly inform translational strategies for cancer prevention within difficult community-based healthcare settings. ### Conditions Module **Conditions:** - Colorectal Cancer **Keywords:** - Early Detection of Cancer - Colorectal Cancer Screening ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 569 **Type:** ACTUAL **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will complete interviewer-administered pre- and post-test **Label:** Control **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training **Intervention Names:** - Behavioral: Physician Intervention **Label:** Physician Intervention **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening **Intervention Names:** - Behavioral: Physician and Patient Intervention **Label:** Physician and Patient Intervention **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Physician Intervention **Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training **Name:** Physician Intervention **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Physician and Patient Intervention **Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening **Name:** Physician and Patient Intervention **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** CRC screening completion via Fecal Occult Blood Test (FOBT), Fecal Immunochemical Test (FIT) or Colonoscopy **Measure:** Colorectal Cancer (CRC) Screening Completion **Time Frame:** within 6 months of provider recommendation **Description:** CRC screening completion via FOBT, FIT or Colonoscopy **Measure:** Colorectal Cancer (CRC) Screening Completion **Time Frame:** within 6 months of provider recommendation #### Secondary Outcomes **Description:** Provider recommendation of CRC Screening based on chart review **Measure:** Provider Recommendation of CRC Screening **Time Frame:** 6 months following patient enrollment into study ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients aged 50-75 years of age (in month 1 of the study) * Patients have had two or more visits to the clinic during the past two years * ACCESS Community Health Network patients * University of Illinois Hospital \& Health Sciences System patients * Patients ages 50 - 75 as of the start of the intervention study * English or Spanish-Speaking Exclusion Criteria: * Patients \<50 or \> 75 years of age * Patients who have had fewer than two or more visits to the clinic during the past two years * Personal history of CRC or colorectal polyps, or of inflammatory bowel disease and a family history with a first-degree relative with CRC or colorectal polyps. * Unable to speak English or Spanish * Compliant with CRC screening (FOBT or FIT within the past year; flexible sigmoidoscopy within past 5 years; colonoscopy within past 10 years) **Healthy Volunteers:** True **Maximum Age:** 75 Years **Minimum Age:** 50 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Chicago **Country:** United States **Facility:** Access Community Health Network **State:** Illinois **Zip:** 60606 **Location 2:** **City:** Chicago **Country:** United States **Facility:** University of Illinois Hospital & Health Sciences System **State:** Illinois **Zip:** 60612 #### Overall Officials **Official 1:** **Affiliation:** Northwestern University **Name:** Kenzie A Cameron, PhD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Cameron KA, Ramirez-Zohfeld V, Ferreira MR, Dolan NC, Radosta J, Galanter WL, Eder MM, Wolf MS, Rademaker AW. The Effects of a Multicomponent Colorectal Cancer Screening Intervention on Knowledge, Recommendation, and Screening among Underserved Populations. J Health Care Poor Underserved. 2020;31(4):1612-1633. doi: 10.1353/hpu.2020.0122. **PMID:** 33416742 **Citation:** Ramirez-Zohfeld V, Rademaker AW, Dolan NC, Ferreira MR, Eder MM, Liu D, Wolf MS, Cameron KA. Comparing the Performance of the S-TOFHLA and NVS Among and Between English and Spanish Speakers. J Health Commun. 2015;20(12):1458-64. doi: 10.1080/10810730.2015.1018629. Epub 2015 Jul 6. **PMID:** 26147770 **Citation:** Dolan NC, Ramirez-Zohfeld V, Rademaker AW, Ferreira MR, Galanter WL, Radosta J, Eder MM, Cameron KA. The Effectiveness of a Physician-Only and Physician-Patient Intervention on Colorectal Cancer Screening Discussions Between Providers and African American and Latino Patients. J Gen Intern Med. 2015 Dec;30(12):1780-7. doi: 10.1007/s11606-015-3381-8. Epub 2015 May 19. **PMID:** 25986137 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007414 - Term: Intestinal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000012002 - Term: Rectal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M17890 - Name: Colorectal Neoplasms - Relevance: HIGH - As Found: Colorectal Cancer - ID: M10448 - Name: Intestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M14844 - Name: Rectal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015179 - Term: Colorectal Neoplasms ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Control **Description:** Participants will complete interviewer-administered pre- and post-test **ID:** EG000 **Other Num at Risk:** 163 **Serious Number At Risk:** 163 **Title:** Control **Group ID:** EG001 **Title:** Physician Training **Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training **ID:** EG001 **Other Num at Risk:** 201 **Serious Number At Risk:** 201 **Title:** Physician Training **Group ID:** EG002 **Title:** Physician and Patient Intervention **Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening **ID:** EG002 **Other Num at Risk:** 174 **Serious Number At Risk:** 174 **Title:** Physician and Patient Intervention **Frequency Threshold:** 0 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 163 **Group ID:** BG001 **Value:** 201 **Group ID:** BG002 **Value:** 174 **Group ID:** BG003 **Value:** 538 **Units:** Participants ### Group **ID:** BG000 **Title:** Control **Description:** Participants will complete interviewer-administered pre- and post-test ### Group **ID:** BG001 **Title:** Physician Intervention **Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training ### Group **ID:** BG002 **Title:** Physician and Patient Intervention **Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening ### Group **ID:** BG003 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 6.07 **Value:** 57.46 #### Measurement **Group ID:** BG001 **Spread:** 6.24 **Value:** 58.71 #### Measurement **Group ID:** BG002 **Spread:** 6.09 **Value:** 57.03 #### Measurement **Group ID:** BG003 **Spread:** 6.17 **Value:** 57.79 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 124 #### Measurement **Group ID:** BG001 **Value:** 144 #### Measurement **Group ID:** BG002 **Value:** 129 #### Measurement **Group ID:** BG003 **Value:** 397 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 39 #### Measurement **Group ID:** BG001 **Value:** 57 #### Measurement **Group ID:** BG002 **Value:** 45 #### Measurement **Group ID:** BG003 **Value:** 141 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 82 #### Measurement **Group ID:** BG001 **Value:** 111 #### Measurement **Group ID:** BG002 **Value:** 93 #### Measurement **Group ID:** BG003 **Value:** 286 **Class Title:** Non-Hispanic Black #### Measurement **Group ID:** BG000 **Value:** 68 #### Measurement **Group ID:** BG001 **Value:** 88 #### Measurement **Group ID:** BG002 **Value:** 75 #### Measurement **Group ID:** BG003 **Value:** 231 **Class Title:** Hispanic #### Measurement **Group ID:** BG000 **Value:** 13 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 6 #### Measurement **Group ID:** BG003 **Value:** 21 **Class Title:** Other/Missing ### Measure #### Measurement **Group ID:** BG000 **Value:** 163 #### Measurement **Group ID:** BG001 **Value:** 201 #### Measurement **Group ID:** BG002 **Value:** 174 #### Measurement **Group ID:** BG003 **Value:** 538 **Class Title:** United States ### Measure #### Measurement **Group ID:** BG000 **Value:** 100 #### Measurement **Group ID:** BG001 **Value:** 118 #### Measurement **Group ID:** BG002 **Value:** 106 #### Measurement **Group ID:** BG003 **Value:** 324 **Class Title:** English #### Measurement **Group ID:** BG000 **Value:** 63 #### Measurement **Group ID:** BG001 **Value:** 83 #### Measurement **Group ID:** BG002 **Value:** 68 #### Measurement **Group ID:** BG003 **Value:** 214 **Class Title:** Spanish ### Measure #### Measurement **Group ID:** BG000 **Value:** 21 #### Measurement **Group ID:** BG001 **Value:** 30 #### Measurement **Group ID:** BG002 **Value:** 27 #### Measurement **Group ID:** BG003 **Value:** 78 **Class Title:** Private #### Measurement **Group ID:** BG000 **Value:** 47 #### Measurement **Group ID:** BG001 **Value:** 68 #### Measurement **Group ID:** BG002 **Value:** 52 #### Measurement **Group ID:** BG003 **Value:** 167 **Class Title:** Medicare #### Measurement **Group ID:** BG000 **Value:** 51 #### Measurement **Group ID:** BG001 **Value:** 71 #### Measurement **Group ID:** BG002 **Value:** 67 #### Measurement **Group ID:** BG003 **Value:** 189 **Class Title:** Medicaid #### Measurement **Group ID:** BG000 **Value:** 66 #### Measurement **Group ID:** BG001 **Value:** 52 #### Measurement **Group ID:** BG002 **Value:** 42 #### Measurement **Group ID:** BG003 **Value:** 160 **Class Title:** Uninsured ### Measure #### Measurement **Group ID:** BG000 **Value:** 99 #### Measurement **Group ID:** BG001 **Value:** 174 #### Measurement **Group ID:** BG002 **Value:** 154 #### Measurement **Group ID:** BG003 **Value:** 427 **Class Title:** Community FQHC #### Measurement **Group ID:** BG000 **Value:** 64 #### Measurement **Group ID:** BG001 **Value:** 27 #### Measurement **Group ID:** BG002 **Value:** 20 #### Measurement **Group ID:** BG003 **Value:** 111 **Class Title:** Academic Health Center ### Measure #### Measurement **Group ID:** BG000 **Value:** 44 #### Measurement **Group ID:** BG001 **Value:** 38 #### Measurement **Group ID:** BG002 **Value:** 35 #### Measurement **Group ID:** BG003 **Value:** 117 **Class Title:** 0 - 6 years #### Measurement **Group ID:** BG000 **Value:** 41 #### Measurement **Group ID:** BG001 **Value:** 64 #### Measurement **Group ID:** BG002 **Value:** 52 #### Measurement **Group ID:** BG003 **Value:** 157 **Class Title:** 7 - 12 years #### Measurement **Group ID:** BG000 **Value:** 76 #### Measurement **Group ID:** BG001 **Value:** 98 #### Measurement **Group ID:** BG002 **Value:** 86 #### Measurement **Group ID:** BG003 **Value:** 260 **Class Title:** 13 or more years #### Measurement **Group ID:** BG000 **Value:** 2 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 1 #### Measurement **Group ID:** BG003 **Value:** 4 **Class Title:** Missing data ### Measure #### Measurement **Group ID:** BG000 **Value:** 101 #### Measurement **Group ID:** BG001 **Value:** 137 #### Measurement **Group ID:** BG002 **Value:** 111 #### Measurement **Group ID:** BG003 **Value:** 349 **Class Title:** <$20,000/year #### Measurement **Group ID:** BG000 **Value:** 22 #### Measurement **Group ID:** BG001 **Value:** 28 #### Measurement **Group ID:** BG002 **Value:** 23 #### Measurement **Group ID:** BG003 **Value:** 73 **Class Title:** $20,000 - $40,000/year #### Measurement **Group ID:** BG000 **Value:** 13 #### Measurement **Group ID:** BG001 **Value:** 6 #### Measurement **Group ID:** BG002 **Value:** 8 #### Measurement **Group ID:** BG003 **Value:** 27 **Class Title:** $40,001 - $100,000/year #### Measurement **Group ID:** BG000 **Value:** 23 #### Measurement **Group ID:** BG001 **Value:** 26 #### Measurement **Group ID:** BG002 **Value:** 27 #### Measurement **Group ID:** BG003 **Value:** 76 **Class Title:** Not sure/Don't know #### Measurement **Group ID:** BG000 **Value:** 4 #### Measurement **Group ID:** BG001 **Value:** 4 #### Measurement **Group ID:** BG002 **Value:** 5 #### Measurement **Group ID:** BG003 **Value:** 13 **Class Title:** Refused/Missing ### Measure #### Measurement **Group ID:** BG000 **Value:** 28 #### Measurement **Group ID:** BG001 **Value:** 28 #### Measurement **Group ID:** BG002 **Value:** 25 #### Measurement **Group ID:** BG003 **Value:** 81 **Class Title:** Poor #### Measurement **Group ID:** BG000 **Value:** 75 #### Measurement **Group ID:** BG001 **Value:** 107 #### Measurement **Group ID:** BG002 **Value:** 88 #### Measurement **Group ID:** BG003 **Value:** 270 **Class Title:** Fair #### Measurement **Group ID:** BG000 **Value:** 39 #### Measurement **Group ID:** BG001 **Value:** 46 #### Measurement **Group ID:** BG002 **Value:** 44 #### Measurement **Group ID:** BG003 **Value:** 129 **Class Title:** Good #### Measurement **Group ID:** BG000 **Value:** 18 #### Measurement **Group ID:** BG001 **Value:** 10 #### Measurement **Group ID:** BG002 **Value:** 12 #### Measurement **Group ID:** BG003 **Value:** 40 **Class Title:** Very Good #### Measurement **Group ID:** BG000 **Value:** 2 #### Measurement **Group ID:** BG001 **Value:** 10 #### Measurement **Group ID:** BG002 **Value:** 4 #### Measurement **Group ID:** BG003 **Value:** 16 **Class Title:** Excellent #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 1 #### Measurement **Group ID:** BG003 **Value:** 2 **Class Title:** Missing ### Measure #### Measurement **Group ID:** BG000 **Value:** 51 #### Measurement **Group ID:** BG001 **Value:** 86 #### Measurement **Group ID:** BG002 **Value:** 67 #### Measurement **Group ID:** BG003 **Value:** 204 **Class Title:** Inadequate #### Measurement **Group ID:** BG000 **Value:** 96 #### Measurement **Group ID:** BG001 **Value:** 97 #### Measurement **Group ID:** BG002 **Value:** 88 #### Measurement **Group ID:** BG003 **Value:** 281 **Class Title:** Marginal/Adequate #### Measurement **Group ID:** BG000 **Value:** 16 #### Measurement **Group ID:** BG001 **Value:** 18 #### Measurement **Group ID:** BG002 **Value:** 19 #### Measurement **Group ID:** BG003 **Value:** 53 **Class Title:** Missing **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** NUMBER **Title:** Race/Ethnicity, Customized **Unit of Measure:** participants ### Measure 4 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ### Measure 5 **Parameter Type:** NUMBER **Title:** Survey Language **Unit of Measure:** participants ### Measure 6 **Parameter Type:** NUMBER **Title:** Insurance Status (more than one may apply) **Unit of Measure:** participants ### Measure 7 **Parameter Type:** NUMBER **Title:** Health Care System **Unit of Measure:** participants ### Measure 8 **Parameter Type:** NUMBER **Title:** Years of Education **Unit of Measure:** participants ### Measure 9 **Parameter Type:** NUMBER **Title:** Household Income **Unit of Measure:** participants ### Measure 10 **Parameter Type:** NUMBER **Title:** Health status **Unit of Measure:** participants ### Measure 11 **Parameter Type:** NUMBER **Title:** Health Literacy **Unit of Measure:** participants **Population Description:** Participants had to reach randomization, complete both pre and post-tests, and be eligible for colorectal cancer screening (verified by chart review). ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** [email protected] **Organization:** Northwestern University **Phone:** 312-503-3910 **Title:** Kenzie A. Cameron ## Results Section - Outcome Measures Module ### Outcome Measure 1 #### Analysis **CI Lower Limit:** 0.62 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 4.38 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.32 **P-Value Comment:** Random effects model adjusting for clustering by clinic **Parameter Type:** Risk Ratio (RR) **Parameter Value:** 1.65 **Statistical Comment:** **Statistical Method:** Mixed Models Analysis **Tested Non-Inferiority:** False ### Outcome Measure 2 #### Analysis **CI Lower Limit:** 0.53 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.20 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.28 **P-Value Comment:** Linear model adjusting for stratification by clinic and participant age **Parameter Type:** Risk Ratio (RR) **Parameter Value:** 0.80 **Statistical Comment:** **Statistical Method:** Mixed Models Analysis **Tested Non-Inferiority:** False ### Outcome Measure 3 #### Analysis **CI Lower Limit:** 0.60 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 3.43 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.42 **P-Value Comment:** Random effects model adjusted for clustering by clinic **Parameter Type:** Risk Ratio (RR) **Parameter Value:** 1.43 **Statistical Comment:** **Statistical Method:** Mixed Models Analysis **Tested Non-Inferiority:** False ### Outcome Measure 4 #### Analysis **CI Lower Limit:** 0.94 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.18 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.38 **P-Value Comment:** Linear model adjusting for stratification by clinic and participant age **Parameter Type:** Risk Ratio (RR) **Parameter Value:** 1.05 **Statistical Comment:** **Statistical Method:** Mixed Models Analysis **Tested Non-Inferiority:** False ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 17 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 69 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 41 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 28 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 70 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 216 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 113 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 103 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** CRC screening completion via Fecal Occult Blood Test (FOBT), Fecal Immunochemical Test (FIT) or Colonoscopy **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** within 6 months of provider recommendation **Title:** Colorectal Cancer (CRC) Screening Completion **Type:** PRIMARY **Unit of Measure:** participants ##### Group **Description:** Participants will complete interviewer-administered pre- and post-test **ID:** OG000 **Title:** Control ##### Group **Description:** Participants in either the Physician Intervention or Physician and Patient Intervention Arms. Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training Physician and Patient Intervention: Physician intervention as described plus patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this co **ID:** OG001 **Title:** Intervention #### Outcome Measure 2 **Description:** CRC screening completion via FOBT, FIT or Colonoscopy **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** within 6 months of provider recommendation **Title:** Colorectal Cancer (CRC) Screening Completion **Type:** PRIMARY **Unit of Measure:** participants ##### Group **Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training **ID:** OG000 **Title:** Physician Intervention ##### Group **Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening **ID:** OG001 **Title:** Physician and Patient Intervention #### Outcome Measure 3 **Description:** Provider recommendation of CRC Screening based on chart review **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** 6 months following patient enrollment into study **Title:** Provider Recommendation of CRC Screening **Type:** SECONDARY **Unit of Measure:** participants ##### Group **Description:** Participants will complete interviewer-administered pre- and post-test **ID:** OG000 **Title:** Control ##### Group **Description:** Participants in either the Physician Intervention or Physician and Patient Intervention Arms. Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training Physician and Patient Intervention: Physician intervention as described plus patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this co **ID:** OG001 **Title:** Intervention #### Outcome Measure 4 **Description:** Provider recommendation of CRC Screening based on chart review **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** 6 months following patient enrollment into study **Title:** Provider Recommendation of CRC Screening **Type:** SECONDARY **Unit of Measure:** participants ##### Group **Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training **ID:** OG000 **Title:** Physician Intervention ##### Group **Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening **ID:** OG001 **Title:** Physician and Patient Intervention ### Participant Flow Module #### Group **Description:** Participants will complete interviewer-administered pre- and post-test **ID:** FG000 **Title:** Control #### Group **Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training **ID:** FG001 **Title:** Physician Intervention #### Group **Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening **ID:** FG002 **Title:** Physician and Patient Intervention #### Period **Title:** Overall Study ##### Withdraw **Type:** Up to date with CRC screening ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 9 ###### Reason **Group ID:** FG002 **Number of Subjects:** 12 ##### Withdraw **Type:** Family history of CRC ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ###### Reason **Group ID:** FG002 **Number of Subjects:** 2 ##### Withdraw **Type:** Active cancer ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ###### Reason **Group ID:** FG002 **Number of Subjects:** 0 ##### Withdraw **Type:** Saw non-study physician ###### Reason **Group ID:** FG000 **Number of Subjects:** 2 ###### Reason **Group ID:** FG001 **Number of Subjects:** 0 ###### Reason **Group ID:** FG002 **Number of Subjects:** 0 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 168 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 210 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 188 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 163 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 201 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 174 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 5 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 9 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 14 **Pre-Assignment Details:** Enrolled participants were excluded from the trial before assignment to groups if they did not reach randomization (e.g. they did not reach the point in the pre-test survey where randomization took place. Therefore they were not assigned to groups. In this study, 3 of the 569 enrolled participants did not reach randomization. **Recruitment Details:** Recruitment for this study took place between September 15, 2010 and January 30, 2013 across seven federally qualified health centers as well as one large academic health center. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT04549779 **Brief Title:** Different Local Anesthetic Volumes in Brachial Plexus Block **Official Title:** Respiratory Sequelae and Analgesic Efficacy of Different Local Anesthetic Volumes in Ultrasound-guided Interscalene Brachial Plexus Block in Patients Presented for Shoulder Arthroscopy #### Organization Study ID Info **ID:** 34017/08/20 #### Organization **Class:** OTHER **Full Name:** Tanta University ### Status Module #### Completion Date **Date:** 2022-08-24 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-06-05 **Type:** ACTUAL **Last Update Submit Date:** 2023-06-02 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-08-24 **Type:** ACTUAL #### Start Date **Date:** 2020-09-19 **Type:** ACTUAL **Status Verified Date:** 2023-06 #### Study First Post Date **Date:** 2020-09-16 **Type:** ACTUAL **Study First Submit Date:** 2020-09-09 **Study First Submit QC Date:** 2020-09-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Tanta University #### Responsible Party **Investigator Affiliation:** Tanta University **Investigator Full Name:** Sameh Abdelkhalik Ahmed Ismaiel **Investigator Title:** Dr **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This prospective randomized study will be carried out on 75 patients in our university hospitals presented for shoulder arthroscopy under general anesthesia and ultrasound-guided interscalene brachial plexus block. All the patients will receive ultrasound-guided interscalene brachial plexus block with injection of local anesthetic volume according to the group of the patient * Group I (25 patients): patients will receive 5 ml levobupivacaine 0.25% ISPB * Group II (25 patients): patients will receive 10 ml levobupivacaine 0.25% ISPB * Group III (25 patients): patients will receive 15 ml levobupivacaine 0.25% ISPB After ensuring adequate sensory and motor blockade, general anesthesia will be carried out. The primary outcome measurement will be the incidence of diaphragmatic hemiparesis 30 minutes after performing the block detected by US assessment of diaphragmatic excursion and the secondary outcome will be the postoperative pain scores and opioid consumption. **Detailed Description:** This prospective randomized double-blind study will be carried out on 75 patients who will be presented for shoulder arthroscopy in Tanta university hospitals over 9 months duration (September 2020- May 2021) which will be started immediately after obtaining the approval from the institutional Ethical Committee. Informed written consent will be obtained from all the participants, all patients data will be confidential and will be used for the current study only. Patients will be randomly classified using a computer-generated software of randomization into 3 groups: * Group I (25 patients): patients will receive 5 ml levobupivacaine 0.25% ISPB * Group II (25 patients): patients will receive 10 ml levobupivacaine 0.25% ISPB * Group III (25 patients): patients will receive 15 ml levobupivacaine 0.25% ISPB Anesthetic technique The patients will be assessed preoperatively in the anesthesia clinic through history taking, examination, and appropriate investigation. Pulmonary function tests (PEFR, FEV1, FVC, and FEV1/FVC) will be performed preoperatively. On arrival of patients to the preparation room, an intravenous line will be established and a fluid preload will be started (7 ml/kg of lactated ringer solution) and the patient will be connected to monitor that consist of 5 leads ECG, non-invasive blood pressure, pulse oximeter, and temperature were applied. The patients will lie supine with ultrasound assessment of the diaphragmatic excursion during quiet breathing, (excluding deep breathing, crying, participants with nasal obstruction, rhinorrhea, or cough, and participants with abdominal pain). Then midazolam 2 mg will be injected slow i.v with the application of nasal cannula (2-3 L/min) to the patient. Then, ultrasound-guided interscalene brachial plexus block will be done under aseptic precaution with an injection of the pre-prepared local anesthetic mixture with its volume according to the group of the patient. The patients will be monitored for 30 minutes before induction of anesthesia, during which assessment of the sensory blockade will be carried out. The sensory block will be assessed by exposure to cold (ice piece) to the area of the shoulder and the upper arm. The motor block will be evaluated by determining patients ability to abduct the shoulder and flex the elbow against gravity (0 = no block Y full strength, 1 = partial block Y weak but able to abduct or flex against gravity, 2 = complete block Y no activity of muscle group). Preserved sensation to the cold or strength to abduct the shoulder after 30 minutes from performing the block at the area of the shoulder and upper arm will be considered as failed block and the patient will be excluded from the study. Ultrasound assessment of the diaphragmatic excursion during quiet breathing will be done again 30 minutes after performing the block. Induction of anesthesia will be carried out after 3 minutes of pre-oxygenation through a well-fitted face mask using 80% oxygen by fentanyl 1 ug/kg, propofol 1.5 mg/kg, and atracurium 0.5 mg/kg to facilitate tracheal intubation. After securing the airway through a suitable sized endotracheal tube, the patient will be connected to a mechanical ventilator with its parameters adjusted to maintain the end-tidal carbon dioxide 34-38 mmHg. Maintenance of the anesthesia will be performed by isoflurane 1.2 % in a low flow gas mixture (1 L/min) composed of oxygen: air 1:1 and incremental doses of atracurium 0.1 mg/kg. A temperature probe will be inserted in the nasopharynx for core temperature monitoring. The depth of anesthesia will be monitored by the bispectral index (Covidien, Mansfield, MA, USA). The BIS values will be kept 40-60. An additional bolus dose of fentanyl 0.5 ug/kg was used in case of increase BIS more than 60 or increase in the heart rate or mean arterial pressure by more than 15 % of the baseline values. At the end of the surgery, the isoflurane will be switched off with reversal of muscle relaxation by neostigmine 0.05 mg/kg and atropine 0.01 mg/kg with awake tracheal extubation and transfer of the patient to the recovery room for postoperative monitoring and supplementation of oxygen through nasal cannula (2-3 L/min). All the patients will receive 4 mg dexamethasone i.v after induction of anesthesia and 4 mg of ondansetron i.v at the end of the surgery to guard against postoperative nausea and vomiting. Also, paracetamol 1 gm i.v infusion every 6 hours will be given routinely to all patients in the postoperative period. In the PACU, ultrasound-guided assessment of the diaphragmatic excursion will be done. Also, pulmonary function (PEFR, FEV1, FVC, and FEV1/FVC) tests will be repeated before discharging the patients from the recovery room after exclusion of the effect of sedation by the aid of the modified observer¡¦s assessment of alertness. Bradycardia (heart rate less than 50 b/min) will be managed by atropine 0.3 mg i.v) and hypotension (mean arterial pressure less than 65 mmHg or decrease by more than 20 % of the pre-anesthesia value) will be managed by ephedrine 10 mg i.v and i.v infusion of ringer lactate that may be repeated. ### Conditions Module **Conditions:** - Diaphragmatic Disorder **Keywords:** - Excursion - Diaphragm - Shoulder arthroscope - Postoperative analgesia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Masking Description:** * The patients will be blinded to their groups. * An anesthesia resident who will not participate in the study and have no subsequent rule in it will help in the preparation of local anesthetic mixtures under strict aseptic precautions. * An assistant nurse who will be blinded to the study groups and will have no subsequent rule in it will help in the collection of the data of measurements. **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 91 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** patients will receive 5 ml levobupivacaine 0.25% in ultrasound-guided interscalene brachial plexus block **Intervention Names:** - Procedure: Low volume interscalene brachial plexus block **Label:** Group I (low volume) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** patients will receive 10 ml levobupivacaine 0.25% in ultrasound-guided interscalene brachial plexus block **Intervention Names:** - Procedure: Intermediate volume interscalene brachial plexus block **Label:** Group II (intermediate volume) **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** patients will receive 15 ml levobupivacaine 0.25% ultrasound-guided interscalene brachial plexus block. **Intervention Names:** - Procedure: High volume interscalene brachial plexus block **Label:** Group III (high volume) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Group I (low volume) **Description:** ultrasound-guided interscalene brachial plexus block with 5 ml levobupivacaine 0.25% **Name:** Low volume interscalene brachial plexus block **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Group II (intermediate volume) **Description:** ultrasound-guided interscalene brachial plexus block with 10 ml levobupivacaine 0.25% **Name:** Intermediate volume interscalene brachial plexus block **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Group III (high volume) **Description:** ultrasound-guided interscalene brachial plexus block with 15 ml levobupivacaine 0.25% **Name:** High volume interscalene brachial plexus block **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The incidence of diaphragmatic hemiparesis 30 minutes after performing the block detected by US assessment of diaphragmatic excursion **Measure:** The incidence of diaphragmatic hemiparesis 3 **Time Frame:** After 30 minutes of performing the block #### Secondary Outcomes **Description:** Postoperative Numerical rating score (NRS) every 2 hours in the first six hours, then every 4 h till 24 h. When NRS scores reach 4 or more, 3 mg of i.v tramadol will be given and can be repeated if required with calculation of the total postoperative morphine consumption in mg in the first 24 hours after surgery and the time to the first request of rescue analgesia. **Measure:** The postoperative pain scores **Time Frame:** Within the first 24 hours after surgery **Description:** The total dose of tramadol consumed in the first 24 hours after surgery **Measure:** The postoperative opioid consumption **Time Frame:** Within 24 hours after surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult patients of both sexes aged (21-70 years) with ASA physical status I-III scheduled for shoulder surgeries. Exclusion Criteria: * Patients with COPD * Sever bronchial asthma * BMI \> 40 kg/m2 * Mental dysfunction * Allergy to local anesthetics * Chronic opioid use * Patients refusal **Maximum Age:** 70 Years **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Tanta **Country:** Egypt **Facility:** Tanta University Hospitals **State:** Algharbia Governate **Zip:** 31511 #### Overall Officials **Official 1:** **Affiliation:** Faculty of Medicine, Tanta University **Name:** Sameh Abdelkhalik **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Contact the principle investigator **Description:** The data of primary outcome will be available with the corresponding author till 6 months after approval of the publication of the trial. **Info Types:** - STUDY_PROTOCOL - SAP - ICF **IPD Sharing:** YES **Time Frame:** The data of primary outcome will be available with the corresponding author till 6 months after approval of the publication of the trial. ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown - ID: M1832 - Name: Levobupivacaine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05545579 **Brief Title:** Comparative Effects of Circuit Training and Trunk Stabilization Technique in Basketball Players **Official Title:** Comparative Effects of Circuit Training and Trunk Stabilization Techniques on Speed, Power and Dynamic Balance in Basketball Players #### Organization Study ID Info **ID:** REC/RCR&AHS/22/0405 #### Organization **Class:** OTHER **Full Name:** Riphah International University ### Status Module #### Completion Date **Date:** 2023-10-22 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-04-03 **Type:** ACTUAL **Last Update Submit Date:** 2023-03-31 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2023-10-15 **Type:** ESTIMATED #### Start Date **Date:** 2022-01-01 **Type:** ACTUAL **Status Verified Date:** 2023-03 #### Study First Post Date **Date:** 2022-09-19 **Type:** ACTUAL **Study First Submit Date:** 2022-09-15 **Study First Submit QC Date:** 2022-09-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Riphah International University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** In the sports world, physical training is the most important factor because physical training increases the efficiency and the effectiveness of the sports. The players performance depends on various factors, but the main factor of players performance is physical training. Training contributes tremendously towards the achievement of such aims of this area in sports. The circuit training is a non-stop, high intensity, basketball specific workout. It increases overall speed and quickness, explosive power, upper and lower body strength, vertical jump and, most of all, the athlete's conditioning. **Detailed Description:** This study will be a randomized control trial and will be conducted in National stadium and Ravians Basketball club Lahore. The study will be completed within the time duration of six months. Non-probability convenience sampling technique will be used to collect the data. The sample size of total 24 athletes will be taken in this study. The participants will be divided into two groups i-e, one group will receive circuit training and other group will receive trunk stabilization exercises. Circuit training consisted of 6 exercises, divided in 2 blocks (1st block contains ½ squats, bench press and pushups and 2nd block contains burpees, squat thrust and lunges) of 3 minutes. The stabilization exercise group will repeat 6 exercises (Balance Ball with Pocket Knife, Reverse Crunch, Russian Return, Shuttle, Leg Lift, and Back extension) for 6 weeks. Lane agility drill, Sprint test, Vertical jump test, Star excursion test will used to evaluate outcomes ### Conditions Module **Conditions:** - Basketball Players ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 24 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Circuit training consisted of 6 exercises, divided in 2 blocks (1st block contains ½ squats, bench press and pushups and 2nd block contains burpees, squat thrust and lunges) of 3 minutes. **Intervention Names:** - Other: circuit trainng **Label:** circuit training **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The stabilization exercise group will repeat 6 exercises (Balance Ball with Pocket Knife, Reverse Crunch, Russian Return, Shuttle, Leg Lift, and Back extension) for 6 weeks. Lane agility drill, Sprint test, Vertical jump test, Star excursion test will used to evaluate outcomes **Intervention Names:** - Other: trunk stabilization techniques **Label:** Trunk stabilization techniques **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - circuit training **Description:** Circuit training consisted of 6 exercises, divided in 2 blocks (1st block contains ½ squats, bench press and pushups and 2nd block contains burpees, squat thrust and lunges) of 3 minutes. The stabilization exercise group will repeat 6 exercises (Balance Ball with Pocket Knife, Reverse Crunch, Russian Return, Shuttle, Leg Lift, and Back extension) for 6 weeks. Lane agility drill, Sprint test, Vertical jump test, Star excursion test will used to evaluate outcomes **Name:** circuit trainng **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Trunk stabilization techniques **Description:** The stabilization exercise group will repeat 6 exercises (Balance Ball with Pocket Knife, Reverse Crunch, Russian Return, Shuttle, Leg Lift, and Back extension) for 6 weeks. Lane agility drill, Sprint test, Vertical jump test, Star excursion test will used to evaluate outcomes **Name:** trunk stabilization techniques **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The Agility T-Test is a popular test for determining how quickly athletes can go forward, backward, and side to side. The client must run 10 meters to point one, sidestep to point two, sidestep to point three, sidestep back to point one, then sprint back to the finish to complete the Agility T-Test. The procedure is then repeated, but in the other direction. From start to finish, each effort is timed and compared to established norms **Measure:** Agility test **Time Frame:** 4 week **Description:** The Vertical Jump test is used to evaluate a candidate's lower-body strength. A vertical jump test gauge is used to conduct the test. Applicants should stand with their feet level and hip width apart beneath the testing gauge, with their dominant side closer to the gauge. The person then raises their dominant arm and fingers vertically over their head. On the test gauge, the test assessor then set the applicant's reach height to zero (0). The leap must be done with both feet flat on the ground without taking a step or running up from the starting position. To safeguard their lower limbs, candidates must take off and land with both feet. Only two (2) tries are permitted for applicants who must leap 30cm or greater **Measure:** Vertical jump test **Time Frame:** 4 week **Description:** The SEBT (Standing Excursion Balance Test) evaluates postural control and dynamic balance. It is currently widely used as a clinical evaluation tool. SEBT necessitates a combination of lower extremity strength, flexibility, and balance. This test is useful in determining whether or not a lower extremity athlete is at danger of injury, as well as musculoskeletal disorders in the lower limb, following a training programmed that improves postural control **Measure:** Star excursion balance test **Time Frame:** 4 week ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Males * Age between 16-30 years * No pain complaint * Recreational activity * Participate voluntarily * Players have spent at least one year in sports Exclusion Criteria: * Higher BMI * joint, meniscus, or ligament damage * lower extremity surgical history * persistent knee instability * cardiac/musculoskeletal/vestibular/neurological issues **Maximum Age:** 30 Years **Minimum Age:** 16 Years **Sex:** MALE **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Imran Amjad, Phd **Phone:** 03324390125 **Role:** CONTACT #### Locations **Location 1:** **City:** Lahore **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Amna Shahid, t-DPT - **Phone:** 03344512823 - **Role:** CONTACT ***Contact 2:*** - **Name:** Shanza Khalid, MS-SPT - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Amna Shahid, t-DPT - **Role:** SUB_INVESTIGATOR **Country:** Pakistan **Facility:** Pakistan sports board **State:** Punjab **Status:** RECRUITING **Zip:** 5433 #### Overall Officials **Official 1:** **Affiliation:** Riphah International University **Name:** Amna Shahid, t-DPT **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03881579 **Brief Title:** Supportive Care for Cognitively Impaired Patients and Families **Official Title:** Supportive Care for Cognitively Impaired Patients and Families #### Organization Study ID Info **ID:** 48000 #### Organization **Class:** OTHER **Full Name:** Stanford University #### Secondary ID Infos **ID:** R01AG062239-01 **Link:** https://reporter.nih.gov/quickSearch/R01AG062239-01 **Type:** NIH ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-04-08 **Type:** ACTUAL **Last Update Submit Date:** 2024-04-04 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2019-12-18 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2019-03-19 **Type:** ACTUAL **Study First Submit Date:** 2018-10-08 **Study First Submit QC Date:** 2019-03-16 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institute on Aging (NIA) #### Lead Sponsor **Class:** OTHER **Name:** Stanford University #### Responsible Party **Investigator Affiliation:** Stanford University **Investigator Full Name:** VJ Periyakoil **Investigator Title:** Director. Palliative Care Education & Training **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Currently almost 5 million Americans suffer from the distressing symptoms related to dementia and this number that will triple by 2050. The overall goals of the proposed project are to evaluate, in community dwelling Alzheimer's Disease Research Center participants the benefits of a 12-month nurse-led early palliative intervention on symptoms, quality of life, health care resource use. The relevance of this research to public health is that there is an urgent need to improve the palliative care of persons with dementia living in the community. This study will contribute substantially to that effort. **Detailed Description:** 200 ADRC participants will be recruited and randomized 100 each to usual care (UC) or {usual care plus an early palliative care intervention} (EPC) to be delivered by a nurse over a twelve-month period. The EPC will include one nurse-led palliative consult for a two-hour virtual session followed by 11 monthly 30-minute phone/video sessions plus usual care. The study aims are to determine whether EPC will lead to (a) eliciting and alleviating the supportive care needs of patients, (b) help them complete and sign (with witnesses) their Advance Directives and the POLST (signed by the patient/proxy and their doctor) upload these into the electronic health records. Exploratory outcomes will include health resource use (e.g. hospital admissions and days, emergency visits) for the participants and caregiver burden for their caregivers. Mixed-methods framework will be utilized to analyze the audiotapes of the encounters between the research nurse and the patient during the twelve intervention sessions and to assess whether the information that is provided to participants differs by patient ethnicity and cognitive levels. ### Conditions Module **Conditions:** - Dementia - Primary Palliative Care - Mild Cognitive Impairment **Keywords:** - palliative - supportive - MCI - palliative care - supportive care - serious illness - RCT - randomized clinical trial - mild cognitive impairment - primary palliative care ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** patients will be randomized to one of two groups: 1. (usual care) or (2). enhanced usual care i.e. usual care plus supportive care provided by a trained and supervised nurse ##### Masking Info **Masking:** SINGLE **Masking Description:** Outcomes will be assessed by blinded research associates **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 200 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** one random half of patients will receive usual care **Intervention Names:** - Behavioral: nurse-led supportive care assessment **Label:** Usual care **Type:** OTHER #### Arm Group 2 **Description:** one random half of patients will receive enhanced usual care (usual care plus nurse-led supportive care intervention) **Intervention Names:** - Behavioral: nurse-led supportive care assessment **Label:** intervention arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Usual care - intervention arm **Description:** Trained project nurses will conduct systematic assessment and provide coaching to patients in the experimental arm **Name:** nurse-led supportive care assessment **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Only the participants randomized to the intervention arm will receive the nurse-led supportive care intervention (one session per month over a twelve-month period). We hypothesize that compared to the control arm, many more patients in the intervention arm will express supportive needs and have them fulfilled by the study nurses. **Measure:** To identify the number of participants who express supportive care needs in both arms. **Time Frame:** Day 0, 4 months, one year **Description:** In both arms the investigators will track the completion, signage and documentation of advance directives and the POLST. AD has to be signed by the patient or proxy and witnessed by two qualifying witnesses. The POLST has to be signed by the patient/proxy and the patient's doctor. Both forms have to be uploaded into the electronic health records. **Measure:** Completion and documentation of advance directives (AD) and the Physicians Orders for Life Sustaining Treatment (POLST) in the electronic health records. **Time Frame:** Day 0, 4 months, one year, 18 months **Description:** The Zarit Burden Interview contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always) . The factor structure is a two-factor model, addressing personal strain and role strain. The investigators will assess change in Zarit scores between three points in time : on study entry, one year later and two year later. **Measure:** Change in Zarit Caregiver Burden scores over time: **Time Frame:** Day 0, 4 months, one year, 18 months #### Secondary Outcomes **Description:** The ESAS is designed to assist in the assessment of nine symptoms common in patients: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing and shortness of breath, (there is also a line labelled "Other Problem"). The severity at the time of assessment of each symptom is rated from 0 to 10 on a numerical scale, 0 meaning that the symptom is absent and 10 that it is of the worst possible severity. The investigators will assess change in ESAS score of all participants at baseline, months 4, 12 and 18. The investigators hypothesize that patients with cognitive impairment will have higher scores than those with normal cognition. The investigators will also determine changes in the ESAS score (if any) over time. **Measure:** Differences in Edmonton Symptoms Assessment Scale (ESAS) scores **Time Frame:** Day 0, 4 months, one year, 18 months **Description:** 3-item survey that assesses a person's underlying knowledge, skills and confidence integral to managing his or her own health and healthcare. PAM segments individuals into one of four activation levels along an empirically derived 100-point scale. Each level provides insight into an extensive array of health-related characteristics, including attitudes, motivators, and behaviors. Individuals in the lowest activation level do not yet understand the importance of their role in managing their own health, and have significant knowledge gaps and limited self-management skills. Individuals in the highest activation level are proactive with their health, have developed strong self-management skills, and are resilient in times of stress or change. PAM measures patient activation and agency: The investigators will assess changes in activation scores in ESAS scores between three points in time : on study entry, one year later and two year later. **Measure:** Change in Patient Activation Measure over time **Time Frame:** one year, two years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All patients enrolled in the Stanford Alzheimers Disease Research Center (SADRC). * All caregivers enrolled in the Stanford Alzheimers Disease Research Center (SADRC). Exclusion Criteria: 1. Institutionalized (not a community dweller) at the time of entry into the study; 2. Have severe dementia and are incapable of responding to the outcome measures at baseline. 3. Participants who live alone and don't have a proxy will be excluded only if they are deemed as lacking the capacity to provide informed consent at the time of entry into the study. **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Palo Alto **Country:** United States **Facility:** VJ Periyakoil **State:** California **Zip:** 94304 #### Overall Officials **Official 1:** **Affiliation:** Stanford University **Name:** VJ Periyakoil, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** by emailing study team **Description:** this will depend on if patients consent or not for release of data **Info Types:** - STUDY_PROTOCOL - SAP **IPD Sharing:** YES **Time Frame:** after study completion ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000003072 - Term: Cognition Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6904 - Name: Dementia - Relevance: LOW - As Found: Unknown - ID: M29705 - Name: Cognitive Dysfunction - Relevance: HIGH - As Found: Mild Cognitive Impairment - ID: M21836 - Name: Neurocognitive Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M6301 - Name: Cognition Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000060825 - Term: Cognitive Dysfunction ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03800979 **Brief Title:** Effectiveness and Safety of Tofacitinib in Patients With Extensive and Recalcitrant Alopecia Areata **Official Title:** Effectiveness and Safety of Tofacitinib in Patients With Extensive and Recalcitrant Alopecia Areata #### Organization Study ID Info **ID:** IRB/IEB 004/2562 #### Organization **Class:** OTHER_GOV **Full Name:** Institute of Dermatology, Thailand ### Status Module #### Completion Date **Date:** 2021-01-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-03-31 **Type:** ACTUAL **Last Update Submit Date:** 2022-03-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-01-30 **Type:** ACTUAL #### Results First Post Date **Date:** 2022-03-10 **Type:** ACTUAL **Results First Submit Date:** 2022-01-23 **Results First Submit QC Date:** 2022-02-15 #### Start Date **Date:** 2019-01-12 **Type:** ACTUAL **Status Verified Date:** 2022-03 #### Study First Post Date **Date:** 2019-01-11 **Type:** ACTUAL **Study First Submit Date:** 2019-01-09 **Study First Submit QC Date:** 2019-01-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Institute of Dermatology, Thailand #### Responsible Party **Investigator Affiliation:** Institute of Dermatology, Thailand **Investigator Full Name:** Chinmanat Lekhavat **Investigator Title:** Assistant Director of Institute of Dermatology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The objective of this study is to assess the safety and efficacy of Tofacitinib in treating patients with extensive and recalcitrant Alopecia Areata (AA), along with to evaluate the economic impact of the patients that may be from changing in their quality of life. There are patients with severe AA who may have little or no improvement from the treatment by diphenylcyclopropenone (DPCP) or topical steroid with minoxidil but instead having positive response from the treatment with Janus kinase(JAK) inhibitor such as Tofacitinib or Ruxolitinib. For the best of my knowledge, there was no previous study in using Tofacitinib to treat severe AA before in Thailand. **Detailed Description:** Alopecia areata (AA) or spot baldness, is a condition in which hair falls off from areas of the body. It often happens on the scalp, causing a few bald spots and it may result in psychological stress even though people are generally healthy. AA is believed to be an autoimmune disease progressing from a breach in the immune privilege of the hair follicles that causes hair to fall out in small patches, it may remain unnoticeable until the patches eventually connect and then become noticeable. It can develop slowly, and also recur after years between occurrences. By standard AA treatment guideline, DPCP is the first treatment protocol and may follow with anthralin or minoxidil. This oldy but goody treatment gives a good result of 75% in spotty hair loss and 25% in total baldness. The new invention of treatment has been introduced in the past 2 years by using JAK inhibitor, an oral medicine such as Tofacitinib and Ruxolitinib. This treatment gives a good outcome so far in this short period of time, 54-81.9% of patients had over 50% increase of hair grows over the original protocol. The theory is that JAK inhibitors would inhibit interferon-gamma and interleukin-15 signal between white blood cell and hair follicle which reducing the rate of destroying hair follicles. The investigators propose the study to assess the safety and efficacy of Tofacitinib for extensive and recalcitrant AA and to evaluate the economic impact effecting the AA patients. Tofacitinib is an expensive medicine and needed to be taken up to 6 months to finish the course to have a best outcome so it is not a popular choice of AA treatment at present time unless it can show a promising result in recalcitrant AA. ### Conditions Module **Conditions:** - Alopecia Areata **Keywords:** - Alopecia areata - Alopecia universalis - Alopecia totalis - Tofacitinib - JAK inhibitor ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** This is a Cohort study which all recruited volunteers will receive Tofacitinib for total of 24 weeks. The 19 volunteers are mixed male and female Thais who suffer from severe AA over 50% of the entire scalp. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 19 **Type:** ACTUAL **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All participants will take Tofacitinib 5 mg twice daily for 24 weeks to treat extensive and recalcitrant alopecia areata. **Intervention Names:** - Drug: Tofacitinib **Label:** Tofacitinib **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Tofacitinib **Description:** Tofacitinib is an oral medicine in Janus kinase inhibitor 3 group which has been approved by FDA in treating Rheumatoid Arthritis. It has ability to inhibit nerve signal Interferon-ɣ and Interleukin-15 between white blood cell(WBC) and the nucleus of hair follicle cell causing the production of WBC type CD8+NKG2D+ T cell to slow down which this type of WBC is one of the cause of hair loss. **Name:** Tofacitinib **Other Names:** - Xeljanz **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The Severity of Alopecia Tool (SALT) is a measurement procedure used by dermatologists to determine the percentage of scalp hair loss. The SALT system divides the scalp into 4 areas: Top has 4 sections of 10% total are 40%, back has 4 sections of 6% total are 24% and the 2 sides, left and right, each has 2 sections of 4% and 2 sections of 5% total of 18% and 36% combined. In the beginning, the area of hair loss would be measured by checking each area for hair loss and determining the bald spots combined per SALT scale then keeping the record as SALT baseline (SALT). The total SALT score is measured 0-100%, with higher values representing greater hair loss. **Measure:** Number of Responders vs Non-Responders Using SALT Score **Time Frame:** 48 weeks #### Secondary Outcomes **Description:** Patients came back for follow-up every month during a total of 24 weeks of treatments and at weeks 28,36 and 48. **Measure:** Side Effects From Tofacitinib **Time Frame:** 48 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Thai volunteers age between 18 and 60 years old. * Volunteers must be patients who suffer from severe AA more than 50% of the entire scalp. * Volunteers must be patients who are able to complete the monthly treatment at least in the first 6 months. Exclusion Criteria: * Patients who suffer from other hair diseases such as: Telogen effluvium, Trichotillomania, Tinea capitis * Patients who have other diseases that can have an impact on hair loss or temporary hair loss condition with in 6 months prior to the study such as: thyroid problems, liver disease, malnutrition, hearth disease, neurological disease, gastrointestinal disorders, sexually transmitted disease, cancer, psychiatric disease. * Patients with AA who received treatment with either steroid, Anthralin or DPCP application within 1 month before the selection or patients who had oral or injection from steroid or other medication for hair loss treatment within 3 months before the selection. * Woman with pregnancy **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bangkok **Country:** Thailand **Facility:** Institute of Dermatology #### Overall Officials **Official 1:** **Affiliation:** Institute of Dermatology **Name:** Chinmanat Lekhavat, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Alkhalifah A, Alsantali A, Wang E, McElwee KJ, Shapiro J. Alopecia areata update: part II. Treatment. J Am Acad Dermatol. 2010 Feb;62(2):191-202, quiz 203-4. doi: 10.1016/j.jaad.2009.10.031. **PMID:** 20115946 **Citation:** Tosti A, Iorizzo M, Botta GL, Milani M. Efficacy and safety of a new clobetasol propionate 0.05% foam in alopecia areata: a randomized, double-blind placebo-controlled trial. J Eur Acad Dermatol Venereol. 2006 Nov;20(10):1243-7. doi: 10.1111/j.1468-3083.2006.01781.x. **PMID:** 17062039 **Citation:** Taylor CR, Hawk JL. PUVA treatment of alopecia areata partialis, totalis and universalis: audit of 10 years' experience at St John's Institute of Dermatology. Br J Dermatol. 1995 Dec;133(6):914-8. doi: 10.1111/j.1365-2133.1995.tb06925.x. **PMID:** 8547044 **Citation:** Liu LY, Craiglow BG, Dai F, King BA. Tofacitinib for the treatment of severe alopecia areata and variants: A study of 90 patients. J Am Acad Dermatol. 2017 Jan;76(1):22-28. doi: 10.1016/j.jaad.2016.09.007. Epub 2016 Nov 2. **PMID:** 27816293 **Citation:** Craiglow BG, Liu LY, King BA. Tofacitinib for the treatment of alopecia areata and variants in adolescents. J Am Acad Dermatol. 2017 Jan;76(1):29-32. doi: 10.1016/j.jaad.2016.09.006. Epub 2016 Nov 2. **PMID:** 27816292 **Citation:** Ibrahim O, Bayart CB, Hogan S, Piliang M, Bergfeld WF. Treatment of Alopecia Areata With Tofacitinib. JAMA Dermatol. 2017 Jun 1;153(6):600-602. doi: 10.1001/jamadermatol.2017.0001. **PMID:** 28355451 **Citation:** Divito SJ, Kupper TS. Inhibiting Janus kinases to treat alopecia areata. Nat Med. 2014 Sep;20(9):989-90. doi: 10.1038/nm.3685. **PMID:** 25198048 **Citation:** Alkhalifah A, Alsantali A, Wang E, McElwee KJ, Shapiro J. Alopecia areata update: part I. Clinical picture, histopathology, and pathogenesis. J Am Acad Dermatol. 2010 Feb;62(2):177-88, quiz 189-90. doi: 10.1016/j.jaad.2009.10.032. **PMID:** 20115945 ## Document Section ### Large Document Module #### Large Docs - Date: 2018-08-27 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 184845 - Type Abbrev: Prot_SAP - Upload Date: 2022-01-23T10:02 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007039 - Term: Hypotrichosis - ID: D000006201 - Term: Hair Diseases - ID: D000012871 - Term: Skin Diseases - ID: D000020763 - Term: Pathological Conditions, Anatomical ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M3846 - Name: Alopecia - Relevance: HIGH - As Found: Alopecia - ID: M3847 - Name: Alopecia Areata - Relevance: HIGH - As Found: Alopecia Areata - ID: M10089 - Name: Hypotrichosis - Relevance: LOW - As Found: Unknown - ID: M9293 - Name: Hair Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: T290 - Name: Alopecia Totalis - Relevance: LOW - As Found: Unknown - ID: T291 - Name: Alopecia Universalis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000505 - Term: Alopecia - ID: D000000506 - Term: Alopecia Areata ### Intervention Browse Module - Ancestors - ID: D000075242 - Term: Janus Kinase Inhibitors - ID: D000047428 - Term: Protein Kinase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: ANeo - Name: Antineoplastic Agents ### Intervention Browse Module - Browse Leaves - ID: M258018 - Name: Tofacitinib - Relevance: HIGH - As Found: Voice - ID: M10407 - Name: Interferons - Relevance: LOW - As Found: Unknown - ID: M1474 - Name: Janus Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M25820 - Name: Protein Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000479163 - Term: Tofacitinib ### Misc Info Module #### Submission Tracking ##### First MCP Info ###### Post Date - Date: 2022-02-16 - Type: ACTUAL - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Tofacitinib **Deaths Num At Risk:** 19 **Description:** All participants will take Tofacitinib 5 mg twice daily for 24 weeks to treat extensive and recalcitrant alopecia areata. Tofacitinib: Tofacitinib is an oral medicine in the Janus kinase inhibitor 3 groups which FDA has approved in treating Rheumatoid Arthritis. It can inhibit nerve signal Interferon-ɣ and Interleukin-15 between white blood cell(WBC) and the nucleus of hair follicle cell causing the production of WBC type CD8+NKG2D+ T cell to slow down which this type of WBC is one of the causes of hair loss. **ID:** EG000 **Other Num Affected:** 9 **Other Num at Risk:** 19 **Serious Number Affected:** 1 **Serious Number At Risk:** 19 **Title:** Tofacitinib **Frequency Threshold:** 5 #### Other Events **Term:** Dyslipidemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Dyslipidemia (mild) **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** **Term:** Upper respiratory tract infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Upper respiratory tract infection such as common cold **Organ System:** Infections and infestations **Source Vocabulary:** **Term:** Myalgia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Myalgia **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** **Term:** Acne **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** **Term:** Weight gain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** **Term:** Constipation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** #### Serious Events **Term:** Intestinal tuberculosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Ileal tuberculosis **Organ System:** Gastrointestinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 19 **Num Events:** 1 **Time Frame:** Patients came back for follow-up every month during a total of 24 weeks of treatments and at weeks 28,36 and 48. ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 19 **Units:** Participants ### Group **ID:** BG000 **Title:** Tofacitinib **Description:** All participants will take Tofacitinib 5 mg twice daily for 24 weeks to treat extensive and recalcitrant alopecia areata. Tofacitinib is the Janus kinase inhibitor, which FDA has approved for Rheumatoid Arthritis. It can inhibit nerve signal Interferon-ɣ and Interleukin-15 between white blood cell(WBC) and the nucleus of hair follicle cell causing the production of WBC type CD8+NKG2D+ T cell to slow down which this type of WBC is one of the causes of hair loss. ### Measure #### Measurement **Group ID:** BG000 **Spread:** 8.75 **Value:** 32.68 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 12 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 7 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 19 **Class Title:** Asian ### Measure #### Measurement **Group ID:** BG000 **Value:** 19 **Class Title:** Thailand ### Measure #### Measurement **Group ID:** BG000 **Spread:** 14.24 **Value:** 95.11 **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** NUMBER **Title:** Race/Ethnicity, Customized **Unit of Measure:** participants ### Measure 4 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Region of Enrollment **Unit of Measure:** Participants ### Measure 5 **Description:** Baseline SALT (Severity of Alopecia Tool) score is the percentage of hair loss. The total SALT score is measured 0-100%, with higher values representing greater hair loss. **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Baseline SALT score **Unit of Measure:** score ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** [email protected] **Organization:** Institute of Dermatology **Phone:** +660847607474 **Title:** Dr. Chinmanat Lekhavat (My old last name is Tangjaturonrusamee.) ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 9 **Title:** Responders (SALT score improved >=50%) ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 10 **Title:** Non-responders (SALT score improved < 50%) #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 9 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** The Severity of Alopecia Tool (SALT) is a measurement procedure used by dermatologists to determine the percentage of scalp hair loss. The SALT system divides the scalp into 4 areas: Top has 4 sections of 10% total are 40%, back has 4 sections of 6% total are 24% and the 2 sides, left and right, each has 2 sections of 4% and 2 sections of 5% total of 18% and 36% combined. In the beginning, the area of hair loss would be measured by checking each area for hair loss and determining the bald spots combined per SALT scale then keeping the record as SALT baseline (SALT). The total SALT score is measured 0-100%, with higher values representing greater hair loss. **Parameter Type:** COUNT_OF_PARTICIPANTS **Reporting Status:** POSTED **Time Frame:** 48 weeks **Title:** Number of Responders vs Non-Responders Using SALT Score **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** All participants will take Tofacitinib 5 mg twice daily for 24 weeks to treat extensive and recalcitrant alopecia areata. Tofacitinib: Tofacitinib is an oral medicine in the Janus kinase inhibitor 3 groups which FDA has approved in treating Rheumatoid Arthritis. It can inhibit nerve signal Interferon-ɣ and Interleukin-15 between white blood cell(WBC) and the nucleus of hair follicle cell causing the production of WBC type CD8+NKG2D+ T cell to slow down which this type of WBC is one of the causes of hair loss. **ID:** OG000 **Title:** Tofacitinib #### Outcome Measure 2 **Description:** Patients came back for follow-up every month during a total of 24 weeks of treatments and at weeks 28,36 and 48. **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** 48 weeks **Title:** Side Effects From Tofacitinib **Type:** SECONDARY **Unit of Measure:** participants ##### Group **Description:** All participants will take Tofacitinib 5 mg twice daily for 24 weeks to treat extensive and recalcitrant alopecia areata. Tofacitinib: Tofacitinib is an oral medicine in the Janus kinase inhibitor 3 groups which FDA has approved in treating Rheumatoid Arthritis. It can inhibit nerve signal Interferon-ɣ and Interleukin-15 between white blood cell(WBC) and the nucleus of hair follicle cell causing the production of WBC type CD8+NKG2D+ T cell to slow down which this type of WBC is one of the causes of hair loss. **ID:** OG000 **Title:** Tofacitinib ### Participant Flow Module #### Group **Description:** All participants will take Tofacitinib 5 mg twice daily for 24 weeks to treat extensive and recalcitrant alopecia areata. Tofacitinib: Tofacitinib is an oral medicine in the Janus kinase inhibitor 3 groups which FDA has approved in treating Rheumatoid Arthritis. It can inhibit nerve signal Interferon-ɣ and Interleukin-15 between white blood cell(WBC) and the nucleus of hair follicle cell causing the production of WBC type CD8+NKG2D+ T cell to slow down which this type of WBC is one of the causes of hair loss. **ID:** FG000 **Title:** Tofacitinib #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 19 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 19 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 **Pre-Assignment Details:** Nineteen participants who met the inclusion criteria were enrolled and received 10 mg/day oral tofacitinib. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT04844879 **Brief Title:** Medacta NextAR TKA Pivotal Trial **Official Title:** Prospective, Multicentre, Single-arm, Open, Confirmatory Trial to Assess Efficacy and Safety of a Navigation System Providing Personalized Soft Tissue Balance Data in Medially-stabilized Total Knee Arthroplasty #### Organization Study ID Info **ID:** P02.022.02 #### Organization **Class:** INDUSTRY **Full Name:** Medacta International SA ### Status Module #### Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-01 **Type:** ACTUAL **Last Update Submit Date:** 2024-04-30 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2023-12-31 **Type:** ACTUAL #### Start Date **Date:** 2021-05-17 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2021-04-14 **Type:** ACTUAL **Study First Submit Date:** 2021-04-08 **Study First Submit QC Date:** 2021-04-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Medacta International SA #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this study is to assess the efficacy and safety of a navigation system providing personalized soft tissue balance data in medially-stabilized total knee arthroplasty (TKA). **Detailed Description:** This is a prospective, multicentre, single-arm, open, confirmatory clinical investigation to assess the efficacy and safety of a navigation system providing personalized soft tissue balance data in medially-stabilized total knee arthroplasty (TKA). Participants will be informed about the study, both orally and in writing, during a preoperative visit. The investigator will answer any questions that may arise and will collect the informed consent. During the study, enrolled participants will be able to withdraw at any time and for any reason. The study is conducted according to the following schedule: * V1 : Inclusion during a preoperative visit * V2: Surgery * V3: Follow-up visit at 2 month post-surgery * V4: Follow-up visit at 6 months post-surgery * V5: Follow-up visit at 12 months post-surgery The following data will be collected: * Oxford Knee Score (OKS), Knee Society Score (KSS), Forgotten Joint Score (FJS) and patient satisfaction at 6 months and 12 months of follow-up; * Radiological analysis at 2 and 12 months of follow-up; * Surgical time (min); * Necessity of soft tissue release to obtain ligament or patellar balance; * Time to discharge (days); * Device deficiencies and peri- and postoperative adverse events. A web-based data collection tool will be used as Electronic Data Capture (EDC). All the information required by the protocol will be collected in electronic case report forms (eCRF). The statistical analysis will be performed according to a pre-established statistical analysis plan. Missing values will not be replaced by estimated values but will be considered as missing in the statistical analysis. ### Conditions Module **Conditions:** - Musculoskeletal Diseases **Keywords:** - total knee arthroplasty - surgical navigation - medially-stabilized TKA ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients suitable to receive Medacta GMK® Sphere system for primary TKA will be invited to take part to the study during the preoperative visit. Follow-ups are performed after 2, 6 and 12 months. Data collection includes clinical and radiological data for preoperative and postoperative assessments, as well as intraoperative details. **Intervention Names:** - Device: NextAR TKA system **Label:** Single-arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Single-arm **Description:** The NextAR TKA system is a surgical guidance system which measures intra-operatively the effect of prosthesis alignment and positioning on soft tissue balance. **Name:** NextAR TKA system **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Oxford Knee Score (OKS) **Measure:** Functional outcome **Time Frame:** 6 months #### Secondary Outcomes **Description:** Oxford Knee Score (OKS) **Measure:** Functional outcome **Time Frame:** 12 months **Description:** Forgotten Joint Score (FJS) **Measure:** Functional outcome **Time Frame:** 6 months and 12 months **Description:** Knee Society Score (KSS) **Measure:** Clinical and functional outcome **Time Frame:** 6 months and 12 months **Description:** Radiological assessment including implant positioning, presence of radiolucent lines, subsidence, migration of components, presence of heterotopic ossifications or osteolysis **Measure:** Radiological outcomes **Time Frame:** 2 months and 12 months **Description:** Surgical time (min) **Measure:** Surgical outcome - Surgical time **Time Frame:** Intraoperative **Description:** Necessity of soft tissue release to obtain ligament or patellar balance (Y/N) **Measure:** Surgical outcome - Necessity of soft tissue release **Time Frame:** Intraoperative **Description:** Time to discharge (days) **Measure:** Surgical outcome -Time to discharge **Time Frame:** 2 months **Description:** Device deficiencies and adverse events **Measure:** Safety outcomes **Time Frame:** Intraoperative, 2 months, 6 months and 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Males and females aged over 18 years at time of surgery. 2. Patients who are scheduled to receive Medacta GMK® Sphere system for primary TKA (class III, CE-marked). 3. Patients with functional contralateral knee (i.e. without the need to use walking aids). 4. Patients willing and able to provide written informed consent for participation. 5. Patients willing to comply with the pre and post-operative evaluation schedule. Exclusion Criteria: 1. Patients with one or more medical conditions identified as a contraindication defined by the labelling on any Medacta implants used in this study: * Patients presenting with progressive local or systemic infection * Muscular loss, neuromuscular disease or vascular deficiency of the affected limb, making the operation unjustifiable. * Severe instability secondary to advanced destruction of condralar structures or loss of integrity of the medial or lateral ligament 2. Patients whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems. 3. Patients affected by concomitant spine, hip, ankle or contralateral knee pathologies that can affect walking capacity. 4. Patients unable to understand and take action. 5. Patients with known allergy to the materials used. 6. Patients in which Medacta GMK® Sphere system is used in emergency interventions. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Schaffhausen **Country:** Switzerland **Facility:** Privatklinik Belair **Zip:** 8200 **Location 2:** **City:** Winterthur **Country:** Switzerland **Facility:** Privatklinik Lindberg **Zip:** 8400 **Location 3:** **City:** Winterthur **Country:** Switzerland **Facility:** Kantonsspital Winterthur **Zip:** 8401 **Location 4:** **City:** Zurich **Country:** Switzerland **Facility:** Uniklinik Balgrist **Zip:** 8008 #### Overall Officials **Official 1:** **Affiliation:** Balgrist University Hospital **Name:** Sandro Fucentese, Prof. Dr. med. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: HIGH - As Found: Musculoskeletal Diseases ### Condition Browse Module - Meshes - ID: D000009140 - Term: Musculoskeletal Diseases ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00774579 **Brief Title:** The Effect of Growth Hormone Replacement on Liver Fat **Official Title:** Growth Hormone Replacement in Adults With Growth Hormone Deficiency (GHD) - The Effect on Liver Fat. #### Organization Study ID Info **ID:** GHD1 #### Organization **Class:** OTHER **Full Name:** Imperial College London ### Status Module #### Completion Date **Date:** 2009-10 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-07-12 **Type:** ACTUAL **Last Update Submit Date:** 2019-04-29 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2009-03 **Type:** ACTUAL #### Results First Post Date **Date:** 2019-07-12 **Type:** ACTUAL **Results First Submit Date:** 2019-04-29 **Results First Submit QC Date:** 2019-04-29 #### Start Date **Date:** 2008-03 **Status Verified Date:** 2009-12 #### Study First Post Date **Date:** 2008-10-17 **Type:** ESTIMATED **Study First Submit Date:** 2008-10-16 **Study First Submit QC Date:** 2008-10-16 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Novo Nordisk A/S #### Lead Sponsor **Class:** OTHER **Name:** Imperial College London #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** We will examine a cohort of growth hormone deficient adults starting growth hormone (GH) replacement. The purpose of this study is to determine whether GH replacement reduces the fat content of the liver. To compare the results we will include growth hormone deficient patients who do not start GH replacement as controls. **Detailed Description:** Adults with untreated growth hormone deficiency (GHD), a condition mostly due to pituitary disease, often show metabolic features similar to those described in the 'metabolic syndrome'. Growth hormone (GH) replacement has been shown to reverse many of these unfavorable changes, with a particular evident reduction of visceral fat. In recent years, a strong correlation between fat accumulation in the liver and features of the metabolic syndrome (particularly visceral fat) has been identified, and 'fatty liver' is now being referred as the hepatic feature of the 'metabolic syndrome'. The effect of GH replacement on liver fat, however, has never been systematically studied. We will assess 15 patients with GHD before and 6 months after starting GH replacement. We will also assess 15 control patients with GHD but who don't go on GH replacement for various reasons. Liver fat will be assessed using MR spectroscopy. Changes in liver fat will be correlated to changes in insulin sensitivity and changes in various inflammatory markers. ### Conditions Module **Conditions:** - Growth Hormone, Recombinant - Fatty Liver **Keywords:** - growth hormone - growth hormone deficiency - liver fat - liver steatosis - growth hormone replacement ### Design Module #### Bio Spec **Description:** plasma, serum, leucocytes, 24-hour urine **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 30 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with growth hormone (GH) deficiency starting GH replacement. **Label:** 1 #### Arm Group 2 **Description:** Patients with growth hormone (GH) deficiency not starting GH replacement. **Label:** 2 ### Outcomes Module #### Primary Outcomes **Description:** IHCL content determined by proton magnetic resonance spectroscopy (1H MRS). **Measure:** Intrahepatocellular Lipid (IHCL) Content **Time Frame:** 6 months #### Secondary Outcomes **Description:** total adipose tissue assessed by MRI scan **Measure:** Total Adipose Tissue **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 20-70 years of age * Growth hormone deficiency, with (cohort 1) or without (cohort 2) planned growth hormone (GH) replacement * clinically stable Exclusion Criteria: * known hepatic disease * Acromegaly * Diabetes mellitus * growth hormone replacement within the last 12 months * cushing's disease, if not cured for at least 12 months * any contraindication to MR studies as set out in the MR safety questionnaire **Maximum Age:** 70 Years **Minimum Age:** 20 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients will be recruited from the endocrine clinics of Imperial College Healthcare NHS Trust. ### Contacts Locations Module #### Locations **Location 1:** **City:** London **Country:** United Kingdom **Facility:** Endocrinology & Metabolic Medicine, Imperial College **Zip:** W2 1NY #### Overall Officials **Official 1:** **Affiliation:** Imperial College London **Name:** Fabian A Meienberg, Dr **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** Imperial College London **Name:** Stephen Robinson, Dr **Role:** STUDY_CHAIR **Official 3:** **Affiliation:** Imperial College London **Name:** Jeremy Cox, Dr **Role:** STUDY_CHAIR **Official 4:** **Affiliation:** Imperial College London **Name:** Ian Godsland, Dr **Role:** STUDY_CHAIR **Official 5:** **Affiliation:** Imperial College London **Name:** Jimmy Bell, Dr **Role:** STUDY_CHAIR **Official 6:** **Affiliation:** Imperial College London **Name:** Desmond G Johnston, Prof **Role:** PRINCIPAL_INVESTIGATOR **Official 7:** **Affiliation:** Imperial College London **Name:** Simon Taylor-Robinson, Prof **Role:** STUDY_CHAIR **Official 8:** **Affiliation:** Imperial College London **Name:** Emma Hatfield, Dr **Role:** STUDY_CHAIR **Official 9:** **Affiliation:** Imperial College London **Name:** Michael Yee, Dr **Role:** STUDY_CHAIR ### References Module #### References **Citation:** Meienberg F, Yee M, Johnston D, Cox J, Robinson S, Bell JD, Thomas EL, Taylor-Robinson SD, Godsland I. Liver fat in adults with GH deficiency: comparison to matched controls and the effect of GH replacement. Clin Endocrinol (Oxf). 2016 Jul;85(1):76-84. doi: 10.1111/cen.13042. Epub 2016 Mar 22. **PMID:** 26895949 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008107 - Term: Liver Diseases - ID: D000004066 - Term: Digestive System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M8375 - Name: Fatty Liver - Relevance: HIGH - As Found: Fatty Liver - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: T5868 - Name: Visceral Steatosis - Relevance: LOW - As Found: Unknown - ID: T2633 - Name: Growth Hormone Deficiency - Relevance: HIGH - As Found: Growth Hormone Deficiency - ID: T3125 - Name: Isolated Growth Hormone Deficiency - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005234 - Term: Fatty Liver ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Hemat - Name: Hematinics ### Intervention Browse Module - Browse Leaves - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** GH Replacement **Description:** Patients with growth hormone (GH) deficiency starting GH replacement. **ID:** EG000 **Other Num at Risk:** 9 **Serious Number At Risk:** 9 **Title:** GH Replacement **Group ID:** EG001 **Title:** Control **Description:** Patients with growth hormone (GH) deficiency not starting GH replacement. **ID:** EG001 **Other Num at Risk:** 9 **Serious Number At Risk:** 9 **Title:** Control **Frequency Threshold:** 0 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 9 **Group ID:** BG001 **Value:** 9 **Group ID:** BG002 **Value:** 18 **Units:** Participants ### Group **ID:** BG000 **Title:** GH Replacement **Description:** Patients with growth hormone (GH) deficiency starting GH replacement. ### Group **ID:** BG001 **Title:** Control **Description:** Patients with growth hormone (GH) deficiency not starting GH replacement. ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 8 **Value:** 53 #### Measurement **Group ID:** BG001 **Spread:** 9 **Value:** 52 #### Measurement **Group ID:** BG002 **Spread:** 9 **Value:** 52 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 7 #### Measurement **Group ID:** BG001 **Value:** 7 #### Measurement **Group ID:** BG002 **Value:** 14 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 2 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 4 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 9 #### Measurement **Group ID:** BG001 **Value:** 9 #### Measurement **Group ID:** BG002 **Value:** 18 **Category Title:** Not Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 9 #### Measurement **Group ID:** BG001 **Value:** 9 #### Measurement **Group ID:** BG002 **Value:** 18 **Class Title:** United Kingdom **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Ethnicity (NIH/OMB) **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ## Results Section - More Information Module ### Certain Agreement **PI Sponsor Employee:** True ### Point of Contact **Email:** [email protected] **Organization:** Imperial College Healthcare London **Phone:** 020 3312 1253 **Title:** Prof. Desmond Johnston ## Results Section - Outcome Measures Module ### Outcome Measure 1 #### Analysis **CI Lower Limit:** **CI Number of Sides:** **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.6 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** ### Outcome Measure 2 #### Analysis **CI Lower Limit:** **CI Number of Sides:** **CI Percentage Value:** **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY **Other Analysis Description:** **P-Value:** 0.1 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 4.53 - **Upper Limit:** - **Value:** -0.63 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 1.46 - **Upper Limit:** - **Value:** 0.11 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 3.2 - **Upper Limit:** - **Value:** -1.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.28 - **Upper Limit:** - **Value:** 0.24 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** IHCL content determined by proton magnetic resonance spectroscopy (1H MRS). **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 6 months **Title:** Intrahepatocellular Lipid (IHCL) Content **Type:** PRIMARY **Unit of Measure:** % change from baseline ##### Group **Description:** Patients with growth hormone (GH) deficiency starting GH replacement. **ID:** OG000 **Title:** GH Replacement ##### Group **Description:** Patients with growth hormone (GH) deficiency not starting GH replacement. **ID:** OG001 **Title:** Control #### Outcome Measure 2 **Description:** total adipose tissue assessed by MRI scan **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 6 months **Title:** Total Adipose Tissue **Type:** SECONDARY **Unit of Measure:** kg ##### Group **Description:** Patients with growth hormone (GH) deficiency starting GH replacement. **ID:** OG000 **Title:** GH Replacement ##### Group **Description:** Patients with growth hormone (GH) deficiency not starting GH replacement. **ID:** OG001 **Title:** Control ### Participant Flow Module #### Group **Description:** Patients with growth hormone (GH) deficiency starting GH replacement. **ID:** FG000 **Title:** GH Replacement #### Group **Description:** Patients with growth hormone (GH) deficiency not starting GH replacement. **ID:** FG001 **Title:** Control #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 9 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 9 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 9 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 9 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 0 **Recruitment Details:** Between April 2008 and April 2009 adult hypopituitary patients with untreated GHD were identified and recruited at the endocrine clinics of Imperial College Healthcare NHS Trust. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT06200779 **Brief Title:** Tailored vs. Empirical Helicobacter Pylori Infection Treatment **Official Title:** Susceptibility-guided vs. Empirical First-line Bismuth Quadruple Therapy of H. Pylori Infection: a National Prospective Multicentric Randomized Controlled Trial. #### Organization Study ID Info **ID:** Clinical Study Protocol 1 #### Organization **Class:** OTHER **Full Name:** Unilabs Portugal ### Status Module #### Completion Date **Date:** 2025-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-08 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-07 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-09 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-01-11 **Type:** ACTUAL **Study First Submit Date:** 2023-12-12 **Study First Submit QC Date:** 2023-12-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Manuel Coelho da Rocha #### Responsible Party **Investigator Affiliation:** Unilabs Portugal **Investigator Full Name:** Manuel Coelho da Rocha **Investigator Title:** Principal Investigator **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Helicobacter pylori (Hp) is a gram-negative bacterium that colonizes human gastric mucosa and is associated with chronic gastritis that can progress to severe complications such as peptic ulcer disease, gastric adenocarcinoma and gastric mucosa-associated lymphoid tissue lymphoma. More than half of the world's population is infected with H. pylori and Portugal is one of the countries with the highest Hp burden. All of infected patients should be treated, however, H. pylori treatment is challenged by the continuously rising antibiotic resistance which has reached alarming levels worldwide. For this reason, it is now well accepted that tailoring treatment of H. pylori infection based on systematic antimicrobial susceptibility testing is useful to avoid the increase of antibiotic resistance. Our aims are to determine prospectively the efficacy and safety of first-line H. pylori eradication treatment based on resistance profile (determined by molecular methods) vs. empirical bismuth quadruple therapy, to evaluate the accuracy of H. pylori detection by polymerase chain reaction (PCR) (vs. histopathological examination) and to estimate the prevalence of H. pylori infection and H. pylori resistance to clarithromycin and levofloxacin in Portugal. This prospective study will be the first national study to investigate the benefits of tailored H. pylori eradication treatment. The investigators expect that this project will be able to demonstrate the non-inferiority of susceptibility-guided treatment comparing with empirical therapy, and our results may change H. pylori treatment recommendations by systematically applying antibiotic susceptibility testing before prescribing eradication therapy. **Detailed Description:** A prospective, multicenter, randomized, controlled interventional trial in two arms: intervention group and control group. Eligible patients will receive oral and written information and will be enrolled after giving written informed consent. In all patients complete gastroscopy with white light will be performed and endoscopic findings will be recorded. For each patient, gastric body and antral biopsies will be collected. All gastric samples will be tested for H. pylori infection by histopathological examination and PCR. All H. pylori positive samples will be tested for clarithromycin (mutations in the 23S rRNA gene, A2134G, A2142G and A2142C mutations) and levofloxacin resistance (mutations in the gyrA gene) by PCR. All H. pylori positive patients will be randomized in two groups: INTERVENTION GROUP: Patients randomized to the Intervention group will receive a prescription for oriented H. pylori eradication treatment according to the following rules: a) clarithromycin-sensitive strain (independently of levofloxacin resistance test result) - PPI, amoxicillin 1 g and clarithromycin 500 mg, twice daily, for 10 days; b) clarithromycin-resistant and levofloxacin-sensitive strain - PPI, amoxicillin 1g and levofloxacin 250 mg, twice daily, for 10 days; c) clarithromycin-resistant and levofloxacin-resistant strain - bismuth quadruple therapy (Pylera®) for 10 days. At least 4 weeks after stopping antibiotics (and at least 2 weeks after stopping PPIs), an eradication control test will be carried out using a respiratory test (urea breath test) or endoscopic biopsies (if clinical indication for that). CONTROL GROUP: Patients randomized to the Control group will receive a prescription for empirically H. pylori eradication treatment with bismuth quadruple therapy (Pylera®) for 10 days. At least 4 weeks after stopping antibiotics (and at least 2 weeks after stopping PPIs), an eradication control test will be carried out using a respiratory test (urea breath test) or endoscopic biopsies (if clinical indication for that). All patients that complete eradication treatment regimen will be evaluated 2 to 4 weeks after performing the eradication control (urea breath test) in a clinical consultation. Eventual adverse effects will be recorded. A negative breath test will define the success of the treatment, while a positive test will define treatment failure. The latter will be managed according to H. pylori infection guidelines. ### Conditions Module **Conditions:** - Helicobacter Pylori Infection **Keywords:** - Helicobacter pylori - Antibiotic resistance - Eradication treatment - Molecular pathology ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Intervention group: Patients will receive a prescription for oriented H. pylori eradication treatment according to the following rules: a) clarithromycin-sensitive strain (independently of levofloxacin resistance test result) - PPI, amoxicillin 1 g and clarithromycin 500 mg, twice daily, for 10 days; b) clarithromycin-resistant and levofloxacin-sensitive strain - PPI, amoxicillin 1g and levofloxacin 250 mg, twice daily, for 10 days; c) clarithromycin-resistant and levofloxacin-resistant strain - bismuth quadruple therapy (Pylera®) for 10 days. Control Group: Patients will receive a prescription for empirically H. pylori eradication treatment with bismuth quadruple therapy (Pylera®) for 10 days. ##### Masking Info **Masking:** SINGLE **Who Masked:** - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 160 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients randomized to the Intervention group will receive a prescription for oriented H. pylori eradication treatment according to the following rules: a) clarithromycin-sensitive strain (independently of levofloxacin resistance test result) - PPI, amoxicillin 1 g and clarithromycin 500 mg, twice daily, for 10 days; b) clarithromycin-resistant and levofloxacin-sensitive strain - PPI, amoxicillin 1g and levofloxacin 250 mg, twice daily, for 10 days; c) clarithromycin-resistant and levofloxacin-resistant strain - bismuth quadruple therapy (Pylera®) for 10 days. At least 4 weeks after stopping antibiotics (and at least 2 weeks after stopping PPIs), an eradication control test will be carried out using a respiratory test (urea breath test) or endoscopic biopsies (if clinical indication for that). **Intervention Names:** - Diagnostic Test: Clarithromycin (mutations in the 23S rRNA gene, A2134G, A2142G and A2142C mutations) and levofloxacin resistance (mutations in the gyrA gene) PCR test - Drug: PPI, amoxicillin 1 g and clarithromycin 500 mg, twice daily, for 10 days - Drug: PPI, amoxicillin 1g and levofloxacin 250 mg, twice daily, for 10 days - Drug: Bismuth quadruple therapy (Pylera®) for 10 days **Label:** Intervention group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Patients randomized to the Control group will receive a prescription for empirically H. pylori eradication treatment with bismuth quadruple therapy (Pylera®) for 10 days. At least 4 weeks after stopping antibiotics (and at least 2 weeks after stopping PPIs), an eradication control test will be carried out using a respiratory test (urea breath test) or endoscopic biopsies (if clinical indication for that). **Intervention Names:** - Drug: Empirically H. pylori eradication treatment with bismuth quadruple therapy (Pylera®) **Label:** Control group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention group **Description:** Described in "Arms" section **Name:** Clarithromycin (mutations in the 23S rRNA gene, A2134G, A2142G and A2142C mutations) and levofloxacin resistance (mutations in the gyrA gene) PCR test **Type:** DIAGNOSTIC_TEST #### Intervention 2 **Arm Group Labels:** - Control group **Description:** Described in "Arms" section **Name:** Empirically H. pylori eradication treatment with bismuth quadruple therapy (Pylera®) **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Intervention group **Description:** Administered to patients randomized to Intervention group and with H. pylori clarithromycin-sensitive strain **Name:** PPI, amoxicillin 1 g and clarithromycin 500 mg, twice daily, for 10 days **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Intervention group **Description:** Administered to patients randomized to Intervention group and with H. pylori clarithromycin-resistant and levofloxacin-sensitive strain **Name:** PPI, amoxicillin 1g and levofloxacin 250 mg, twice daily, for 10 days **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - Intervention group **Description:** Administered to patients randomized to Intervention group and with H. pylori clarithromycin-resistant and levofloxacin-resistant strain **Name:** Bismuth quadruple therapy (Pylera®) for 10 days **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** This comparation will allow the investigators to show the non-inferiority of susceptibility-guided treatment comparing with empirical therapy **Measure:** Percentage of successful H. pylori eradication treatment in intervention group vs. control group. **Time Frame:** 12 months #### Secondary Outcomes **Description:** All gastric samples will be tested for H. pylori infection by histopathological examination and PCR. This comparation will allow the investigators to analyze tha diagnostica accuracy of PCR vs. histopathological examination **Measure:** Percentage of H. pylori detection in gastric samples by PCR vs. histopathological examination. **Time Frame:** 12 months **Measure:** Estimate the prevalence of H. pylori infection in Portugal. **Time Frame:** 12 months **Measure:** Estimate the prevalence of H. pylori resistance to clarithromycin and levofloxacin in Portugal. **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Individuals older than 18 years old scheduled for upper GI endoscopy with indication for gastric biopsies (clinical or endoscopic findings) Exclusion Criteria: * 1st phase (clinical): patients who had received antimicrobial therapy 1 month prior to endoscopy; patients who had received proton pump inhibitor (PPI) therapy 2 weeks prior to endoscopy; patients who had ever received H. pylori eradication therapy (despite its efficacy); history of previous gastrectomy; non-Portuguese nationality; pregnant or breastfeeding women; women of childbearing age without effective contraception; suspected or documented allergy to amoxicillin; serious comorbidities (ASA 3 or more); ongoing medication with anticoagulants * 2nd phase (endoscopic): upper GI tract neoplasia; hemorrhagic gastritis; upper GI tract varices * 3rd phase (pathological): H. pylori negative patients **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Porto **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Manuel Coelho da Rocha, MD - **Phone:** +351964607421 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Pedro Pimentel Nunes, MD PhD - **Phone:** +351967340096 - **Role:** CONTACT **Country:** Portugal **Facility:** Unilabs Portugal **Zip:** 4150-178 ### IPD Sharing Statement Module **Description:** All IPD that underlie results in a publication **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES **Time Frame:** Starting in May 2025 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000016905 - Term: Gram-Negative Bacterial Infections - ID: D000001424 - Term: Bacterial Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infection - ID: M7380 - Name: Disease Susceptibility - Relevance: LOW - As Found: Unknown - ID: M18886 - Name: Helicobacter Infections - Relevance: HIGH - As Found: Helicobacter Pylori Infection - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M19249 - Name: Gram-Negative Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000016481 - Term: Helicobacter Infections ### Intervention Browse Module - Ancestors - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000011500 - Term: Protein Synthesis Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000065692 - Term: Cytochrome P-450 CYP3A Inhibitors - ID: D000065607 - Term: Cytochrome P-450 Enzyme Inhibitors - ID: D000000892 - Term: Anti-Infective Agents, Urinary - ID: D000059005 - Term: Topoisomerase II Inhibitors - ID: D000059003 - Term: Topoisomerase Inhibitors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000065609 - Term: Cytochrome P-450 CYP1A2 Inhibitors - ID: D000000863 - Term: Antacids - ID: D000005765 - Term: Gastrointestinal Agents - ID: D000000981 - Term: Antiprotozoal Agents - ID: D000000977 - Term: Antiparasitic Agents - ID: D000000897 - Term: Anti-Ulcer Agents ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M16759 - Name: Tin Fluorides - Relevance: LOW - As Found: Unknown - ID: M3995 - Name: Amoxicillin - Relevance: HIGH - As Found: Pembrolizumab - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M30370 - Name: Levofloxacin - Relevance: HIGH - As Found: Sodium chloride - ID: M17946 - Name: Ofloxacin - Relevance: HIGH - As Found: Sodium chloride - ID: M5011 - Name: Bismuth - Relevance: HIGH - As Found: Airway Pressure - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M19585 - Name: Clarithromycin - Relevance: HIGH - As Found: Prescription - ID: M1804 - Name: Carbamide Peroxide - Relevance: LOW - As Found: Unknown - ID: M11767 - Name: Metronidazole - Relevance: HIGH - As Found: Scoliosis Surgery - ID: M16520 - Name: Tetracycline - Relevance: HIGH - As Found: Scoliosis Surgery - ID: M226511 - Name: Bismuth tripotassium dicitrate - Relevance: HIGH - As Found: Scoliosis Surgery - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M30564 - Name: Cytochrome P-450 CYP3A Inhibitors - Relevance: LOW - As Found: Unknown - ID: M30537 - Name: Cytochrome P-450 Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4188 - Name: Antacids - Relevance: LOW - As Found: Unknown - ID: M4219 - Name: Anti-Ulcer Agents - Relevance: LOW - As Found: Unknown - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown - ID: M4298 - Name: Antiprotozoal Agents - Relevance: LOW - As Found: Unknown - ID: M4294 - Name: Antiparasitic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000658 - Term: Amoxicillin - ID: D000017291 - Term: Clarithromycin - ID: D000064704 - Term: Levofloxacin - ID: D000015242 - Term: Ofloxacin - ID: D000008795 - Term: Metronidazole - ID: D000013752 - Term: Tetracycline - ID: C000002791 - Term: Bismuth tripotassium dicitrate - ID: D000001729 - Term: Bismuth ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00007579 **Brief Title:** To Explore Racial Differences in Potential Risk Factors for Developing Prostate Cancer in the VA Population. **Official Title:** Prostate Cancer Case-Control Study: Black Versus White: VA Versus Private Sector #### Organization Study ID Info **ID:** 708D #### Organization **Class:** FED **Full Name:** VA Office of Research and Development ### Status Module #### Expanded Access Info #### Last Update Post Date **Date:** 2008-10-17 **Type:** ESTIMATED **Last Update Submit Date:** 2008-10-16 **Overall Status:** COMPLETED #### Start Date **Date:** 1998-02 **Status Verified Date:** 2003-02 #### Study First Post Date **Date:** 2001-01-01 **Type:** ESTIMATED **Study First Submit Date:** 2000-12-29 **Study First Submit QC Date:** 2000-12-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** FED **Name:** US Department of Veterans Affairs #### Responsible Party **Old Name Title:** Walther, Philip - Study Chair **Old Organization:** Department of Veterans Affairs ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Primary Objectives: To explore racial differences in potential risk factors for developing prostate cancer in the VA population and to compare and contrast the results of this study with that of an ongoing NCI-funded study in North Carolina. Secondary Objectives: To investigate familial aggregation of prostate cancer in blacks and whites. To determine whether screening behavior differs in men diagnosed with early stage prostate cancer versus those with later stage disease as well as to determine if screening behavior differences exist between blacks and whites. Primary Outcomes: The primary outcomes are pesticide, occupational and chemical exposure, and dietary history. Other major endpoints include: 1) familial aggregation of prostate cancer; 2) weight, weight history, and weight cycling; 3) subject's knowledge, attitudes, and behaviors about prostate cancer; and 4) treatment choices. Intervention: N/A Study Abstract: Prostate cancer is the most commonly diagnosed cancer in American men. Among African Americans the incidence and mortality from prostate cancer is even greater. Although incidence rates in the Southern United States tend to be only slightly higher than that of the nation, a clear discrepancy exists between national mortality rates and those in the Southeastern United States. Notably high rates, particularly among African Americans are observed and in North Carolina the prostate cancer mortality rate among African Americans is the highest of any state in the nation. In spite of these statistics, very little is known about racially based differences in the etiology of this disease. This study hypothesizes that racial differences in the incidence and mortality of prostate cancer may be a result of multiple factors including those that are socioeconomic, environmental, dietary and genetic. This research will provide insight into gene-environmental interactions that initiate and promote prostatic neoplasia as well as address whether there are differences in patterns of care which impact morbidity and survival. The results of this study will also be compared to findings in non-veterans that are being generated through an NCI-funded sister study of these issues under the direction of co-investigator, Dr. JoEllen Schildkraut of Duke University. Subjects were identified from pathology reports extracted from VISTA. Additionally, subjects were identified by reviewing radiation/oncology clinic records for those subjects referred for radiation treatment. Subject enrollment concluded with 100 cases and 98 controls enrolled in the study **Detailed Description:** Primary Objectives: To explore racial differences in potential risk factors for developing prostate cancer in the VA population and to compare and contrast the results of this study with that of an ongoing NCI-funded study in North Carolina. Secondary Objectives: To investigate familial aggregation of prostate cancer in blacks and whites. To determine whether screening behavior differs in men diagnosed with early stage prostate cancer versus those with later stage disease as well as to determine if screening behavior differences exist between blacks and whites. Primary Outcomes: The primary outcomes are pesticide, occupational and chemical exposure, and dietary history. Other major endpoints include: 1) familial aggregation of prostate cancer; 2) weight, weight history, and weight cycling; 3) subject's knowledge, attitudes, and behaviors about prostate cancer; and 4) treatment choices. Intervention: N/A Study Abstract: Prostate cancer is the most commonly diagnosed cancer in American men. Among African Americans the incidence and mortality from prostate cancer is even greater. Although incidence rates in the Southern United States tend to be only slightly higher than that of the nation, a clear discrepancy exists between national mortality rates and those in the Southeastern United States. Notably high rates, particularly among African Americans are observed and in North Carolina the prostate cancer mortality rate among African Americans is the highest of any state in the nation. In spite of these statistics, very little is known about racially based differences in the etiology of this disease. This study hypothesizes that racial differences in the incidence and mortality of prostate cancer may be a result of multiple factors including those that are socioeconomic, environmental, dietary and genetic. This research will provide insight into gene-environmental interactions that initiate and promote prostatic neoplasia as well as address whether there are differences in patterns of care which impact morbidity and survival. The results of this study will also be compared to findings in non-veterans that are being generated through an NCI-funded sister study of these issues under the direction of co-investigator, Dr. JoEllen Schildkraut of Duke University. Subjects are identified from pathology reports extracted from VISTA. It has been determined that pathology reports alone are not a sufficient source of identifying cases because not all patients coming to VA for treatment have diagnostic pathology completed at the Durham VA. Therefore, we have added additional protocols for subject identification such as reviewing radiation/oncology clinic records for those subjects referred for radiation treatment. To-date, 78 cases and 66 controls have been enrolled in the study. To increase accrual rates, in-home visits have been used when necessary, and the Richmond, VA and Asheville, NC VAMCs have been added as participating study sites. Due to patient accrual problems and project staffing changes, the Durham ERIC has granted this study a six-month, no-cost extension through 7/31/2001. ### Conditions Module **Conditions:** - Prostate Cancer **Keywords:** - prostate cancer ### Design Module **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Label:** 1 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Veterans with Prostate Cancer Exclusion Criteria: **Maximum Age:** 74 Years **Minimum Age:** 40 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Durham **Country:** United States **Facility:** VA Medical Center, Durham **State:** North Carolina **Zip:** 27705 #### Overall Officials **Official 1:** **Affiliation:** VA Medical Center, Durham **Name:** Philip Walther **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005834 - Term: Genital Neoplasms, Male - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000005832 - Term: Genital Diseases, Male - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000011469 - Term: Prostatic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14335 - Name: Prostatic Neoplasms - Relevance: HIGH - As Found: Prostate Cancer - ID: M8946 - Name: Genital Neoplasms, Male - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M8944 - Name: Genital Diseases, Male - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14333 - Name: Prostatic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011471 - Term: Prostatic Neoplasms ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06419179 **Acronym:** GUIDANCE **Brief Title:** Maintenance Durvalumab (MEDI4736) and Olaparib (AZD2281) After Standard 1st Line Treatment (Carboplatin/Cisplatin, Etoposide, Durvalumab) in HRD Positive Extensive Disease (ED) Small-cell Lung Cancer (SCLC) **Official Title:** A Multicenter Phase II Trial of Maintenance Durvalumab (MEDI4736) and Olaparib (AZD2281) After Standard 1st Line Treatment (Carboplatin/Cisplatin, Etoposide, Durvalumab) in Homologous Recombination Deficiency (HRD) Positive Extensive Disease (ED) Small-cell Lung Cancer (SCLC) #### Organization Study ID Info **ID:** Uni-Koeln-5159 #### Organization **Class:** OTHER **Full Name:** University of Cologne #### Secondary ID Infos **ID:** 2024-512373-27-00 **Type:** CTIS ### Status Module #### Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-09 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** AstraZeneca #### Lead Sponsor **Class:** OTHER **Name:** University of Cologne #### Responsible Party **Investigator Affiliation:** University of Cologne **Investigator Full Name:** Prof. Dr. Juergen Wolf **Investigator Title:** Clinical Prof. Dr. Jürgen Wolf **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** Maintenance durvalumab (MEDI4736) and olaparib (AZD2281) after standard 1st line treatment (carboplatin/ cisplatin, etoposide, durvalumab) in HRD positive extensive disease (ED) small-cell lung cancer (SCLC) ### Conditions Module **Conditions:** - Small Cell Lung Carcinoma ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 29 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Study treatment (olaparib and durvalumab) starts with the initiation of maintenance therapy and is administered at a 28-day cycle until progression, unacceptable toxicity, or discontinuation for other reasons. Induction therapy (four cycles of carboplatin/cisplatin, etoposide, durvalumab) is administered as part of standard of care. **Intervention Names:** - Drug: Durvalumab - Drug: Olaparib **Label:** Combination of olaparib and durvalumab after four cycles of standard 1st line treatment **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Combination of olaparib and durvalumab after four cycles of standard 1st line treatment **Description:** 1500 mg i.v. Q4W **Name:** Durvalumab **Other Names:** - MEDI4736 - IMFINZI **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Combination of olaparib and durvalumab after four cycles of standard 1st line treatment **Description:** 300 mg BID orally **Name:** Olaparib **Other Names:** - AZD2281 - LYNPARZA **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** PFS according to investigator-assessed RECIST 1.1 from start of maintenance therapy **Measure:** Progression-free survival (PFS) **Time Frame:** Approximately two years (from First patient in (FSI) to Last patient last visit (LSLV)) #### Secondary Outcomes **Description:** Grading is based on CTCAE Version 5 **Measure:** Incidence, severity and grading of adverse events (AE) and seriouse adverse events (SAE). **Time Frame:** Approximately two years (from FSI to LSLV) **Description:** Grading is based on RECIST 1.1 **Measure:** ORR of maintenance. **Time Frame:** Approximately two years (from FSI to LSLV) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria Pre-Screening: * Newly diagnosed, histologically documented advanced or metastatic small-cell lung cancer (UICC stage III which is not amenable to curative radiochemotherapy or stage IV). \[...\] * Either de novo biopsies collected as part of routine clinical practice or archival tumor samples (taken ≤6 months prior to screening) are acceptable. * Planned or ongoing treatment with carboplatin/cisplatin, etoposide, durvalumab as 1st-line SoC. Pre-screening must begin no later than the start of the 3rd cycle to allow sufficient time for molecular analyses. \[...\] * Available radiographic chest and abdominal CT or MRI scans performed up to 42 days before initial first line treatment with carboplatin/cisplatin, etoposide and durvalumab. * At least one measurable site of disease as defined by RECIST v1.1 criteria. * \[...\] Inclusion Criteria Screening: * Completed pre-screening with fulfillment of all inclusion and exclusion criteria of pre-screening. Pre-screening must have tested positive for homologous recombination deficiency as defined in this protocol at central testing. \[...\] * Patients must not have radiographic or clinic disease progression while on induction therapy and/or prior to start of study treatment. * Patients must have received 4 cycles (21-day cycles) of chemoimmunotherapy with carboplatin or cisplatin, etoposide and durvalumab completed within 1 to 14 days prior to initiation of study treatment on C5D1. * Adequate organ and marrow function Exclusion Criteria Pre-Screening: * Induction therapy other than carboplatin/cisplatin, etoposide and durvalumab. * Radiographic or clinical evidence of progressive disease. * Negative HRD result in a previous pre-screening in this trial. * \[...\] Exclusion Criteria Screening: * Patients with symptomatic uncontrolled central nervous system (CNS) metastases. * Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days. * History of leptomeningeal carcinomatosis. * Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy. Exceptions are: 1. Alopecia (any Grade) 2. Vitiligo (any Grade) 3. Hypothyroidism stable on hormone replacement (Grade ≤2) 4. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician 5. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or olaparib may be included only after consultation with the Sponsor. 6. ... **Maximum Age:** 120 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jürgen Wolf, MD **Phone:** +49 221 478 **Phone Ext:** 89050 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Felix John, MD **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002283 - Term: Carcinoma, Bronchogenic - ID: D000001984 - Term: Bronchial Neoplasms - ID: D000008175 - Term: Lung Neoplasms - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M28323 - Name: Small Cell Lung Carcinoma - Relevance: HIGH - As Found: Small Cell Lung Carcinoma - ID: M5540 - Name: Carcinoma, Bronchogenic - Relevance: LOW - As Found: Unknown - ID: M5260 - Name: Bronchial Neoplasms - Relevance: LOW - As Found: Unknown - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: T5271 - Name: Small Cell Lung Cancer - Relevance: HIGH - As Found: Small Cell Lung Cancer ### Condition Browse Module - Meshes - ID: D000055752 - Term: Small Cell Lung Carcinoma ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000067856 - Term: Poly(ADP-ribose) Polymerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M6182 - Name: Cisplatin - Relevance: LOW - As Found: Unknown - ID: M18650 - Name: Carboplatin - Relevance: LOW - As Found: Unknown - ID: M272500 - Name: Durvalumab - Relevance: HIGH - As Found: Non-Small Cell - ID: M233003 - Name: Olaparib - Relevance: HIGH - As Found: Fentanyl - ID: M8191 - Name: Etoposide - Relevance: LOW - As Found: Unknown - ID: M341643 - Name: Etoposide phosphate - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M205 - Name: Poly(ADP-ribose) Polymerase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000613593 - Term: Durvalumab - ID: C000531550 - Term: Olaparib ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03462979 **Brief Title:** Effects of Home Gluten Immunogenic Peptide Testing on Children With Celiac Disease **Official Title:** GlPs Improve Practice (GIP) at Home: Effects of Home Gluten Immunogenic Peptide Testing on Children With Celiac Disease #### Organization Study ID Info **ID:** P00024698 #### Organization **Class:** OTHER **Full Name:** Boston Children's Hospital ### Status Module #### Completion Date **Date:** 2023-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2022-01-20 **Type:** ACTUAL **Last Update Submit Date:** 2022-01-05 **Overall Status:** SUSPENDED #### Primary Completion Date **Date:** 2021-12-31 **Type:** ACTUAL #### Start Date **Date:** 2018-04-15 **Type:** ACTUAL **Status Verified Date:** 2022-01 #### Study First Post Date **Date:** 2018-03-13 **Type:** ACTUAL **Study First Submit Date:** 2018-03-05 **Study First Submit QC Date:** 2018-03-09 **Why Stopped:** covid-19 pandemic ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Glutenostics, LLC #### Lead Sponsor **Class:** OTHER **Name:** Boston Children's Hospital #### Responsible Party **Investigator Affiliation:** Boston Children's Hospital **Investigator Full Name:** Jocelyn Silvester **Investigator Title:** Instructor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study aims to investigate how knowledge of gluten immunogenic peptide (GIP) levels in stool and urine affects subsequent adherence to a gluten-free diet. Half of the participants will receive results in real-time using a home device and the other half will store samples to be tested at the end of the 30 week study. Participants will also have a diet review with a dietitian at the beginning of the end of their study and be asked questions about their symptoms, gluten-free diet adherence and quality of life. **Detailed Description:** Following a gluten-free diet is difficult. Eating small amounts of gluten may be common. Gluten may cause a wide range of symptoms, or no symptoms at all. Thus, there is not always a 'feedback loop' to alert to accidental gluten exposure. Nevertheless, these "silent" gluten exposures may interfere with recovery and healing of the intestine. New tools are available to test for fragments of gluten - Gluten Immunogenic Peptides (GIPs) in urine and stool. The goal of this research study is to evaluate how knowledge of gluten-immunogenic peptide (GIP) levels in urine and stool affects subsequent adherence to a gluten-free diet. Participants will be children with celiac disease recruited at Boston Children's Hospital. All participants will undergo a diet assessment by a dietitian at the beginning and end of the study. At random intervals, participants will be prompted to collect their next urine sample and complete a survey related to symptoms and diet adherence. Half of the participants will store the sample to be tested later and the rest of the participants will be provided with devices to test their urine at home to receive immediate results. Participants in the home testing group will also be given a set of stool tests (x4) to use at their own discretion during the study period, and will report results and reasons for test use to the research team. GIP test results will be compared to other measures of celiac disease and gluten-free diet adherence, including antibody tests. These findings will help to determine how these new tools can be used to improve gluten-free diet adherence and symptoms and the effect on quality of life. ### Conditions Module **Conditions:** - Celiac Disease - Gluten Sensitivity - Gluten Enteropathy - Gastrointestinal Disease - Digestive System Disease - Diet Modification - Intestinal Disease - Malabsorption Syndromes - Patient Compliance - Diagnostic Self Evaluation - Quality of Life **Keywords:** - Gluten-free diet - Urine - Stool - home testing ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants in the open results arm will be provided with Gluten Detective home testing kits (immunochromatographic lateral flow tests) at week 8 of the study for immediate qualitative (yes/no) feedback about the presence of biomarkers of gluten in their stool and/or urine. During the period from week 8 to week 30, participants will be contacted a total of 6 times at random intervals to collect and test urine samples and complete a questionnaire.Additionally, participants will be given 4 stool test kits, with instructions that they may use these at times of their choosing and will report results and reasons for test use, if any. During this time participants will also keep a diary of suspected gluten exposures. All samples collected will be returned during the week 30 study visit. **Intervention Names:** - Device: Immunochromatographic lateral flow test **Label:** Open Results with home testing **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants in the blinded arms will not be given a test kit but will be given sample collection materials. During the period from week 8 to week 30 of the study, participants will be contacted a total of 6 times at random intervals, instructed to collect urine samples, and complete a questionnaire. Participants will also keep a diary of suspected gluten exposures. All samples collected will be returned during the week 30 study visit. After completion of sample collection, all participants will be unblinded and notified of the results once the samples have been processed. **Label:** Blinded (sample collection only) **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Open Results with home testing **Description:** The immunochromatographic lateral flow test (Gluten Detective) is an at-home test that detects gluten immunogenic peptides excreted in stool or urine. This test can detect gluten exposures which occurred either during the last 24 hours (urine) or within up to a 7 day window (stool). Minimum intake amounts of gluten for successful detection using these test are 50mg (stool) to 500mg (urine) **Name:** Immunochromatographic lateral flow test **Other Names:** - Gluten Detective **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Gluten exposure frequency is defined as the average per individual subject post-randomization percentage of samples collected between weeks 8 and 30 with detectable gluten immunogenic peptides using the qualitative assay (Gluten Detective) **Measure:** Difference in frequency of gluten exposure in open results vs blinded groups following randomization. **Time Frame:** Weeks 8 to 30 #### Secondary Outcomes **Description:** Mean gluten exposure is defined as the average per individual subject post-randomization concentration of gluten immunogenic peptides detected using the quantitative assay **Measure:** Difference in quantity of mean gluten exposure following randomization in blinded vs. open results groups **Time Frame:** weeks 8 - 30 **Description:** Symptom score (using the Celiac Disease PedsRO or ObsRO as appropriate for age) at week 30 **Measure:** Celiac disease symptom score in blinded vs. open results group at the end of the study **Time Frame:** Week 30 **Description:** Symptom score (using the Celiac Disease PedsRO or ObsRO as appropriate) and the change in symptom score between the end of the run-in period (week 8) and the end of the study period (week 30) will be calculated arithmetically. **Measure:** Change in symptom score in blinded vs. open results group **Time Frame:** weeks 8 and 30 **Description:** The CDDUX is a disease specific quality of life instrument for children with celiac disease. **Measure:** Change in celiac disease specific quality of life as measured by Celiac Disease DUX (CDDUX) in blinded vs. open results groups **Time Frame:** weeks 8 and 30 **Description:** The PedsQL 4.0 Generic Core is a validated pediatric general quality of life measure that is caregiver reported for younger children and both child and caregiver reported for older children. The score is scaled from 0 (lowest) to 100 (highest) with higher scores corresponding to better health related quality of life. **Measure:** Change in pediatric health related quality of life as measured by PedsQL 4.0 generic core scale in blinded vs. open results groups **Time Frame:** weeks 8 and 30 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 6 to 18 years at study entry * Diagnosis of celiac disease based upon either 1. Biopsy criteria i) Marsh 3 lesion and/or villous height:crypt depth ratio (Vh:Cd) \< 3 with intraepithelial lymphocytosis; and ii) Elevated serum tTG IgA and/or EMA antibodies 2. Serologic/genetic (ESPGHAN 2012) criteria i) Symptoms compatible with celiac disease; ii) Serum tTG IgA \> 10 x upper limit of normal for assay; iii) EMA titre elevated on a separate sample; and iv) HLADQ genotype compatible with celiac disease. * Adherence to a gluten-restricted diet (self-reported) for 6 months or more * Attending a clinician assessment for celiac disease at Boston Children's Hospital Exclusion Criteria: * Unable to provide urine and/or stool sample or attend study visits * English proficiency unsuitable for completion of surveys * Anuria or oliguria * Reliance upon commercial gluten-free formulas as primary source of nutrition * Comorbid condition that in the opinion of the investigator would interfere with the subject's participation in the study or would confound the results of the study **Maximum Age:** 18 Years **Minimum Age:** 6 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Boston **Country:** United States **Facility:** Boston Children's Hospital **State:** Massachusetts **Zip:** 02115 #### Overall Officials **Official 1:** **Affiliation:** Boston Children's Hospital, Beth Israel Deaconess Medical Center **Name:** Jocelyn A Silvester, MD PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Moreno ML, Cebolla A, Munoz-Suano A, Carrillo-Carrion C, Comino I, Pizarro A, Leon F, Rodriguez-Herrera A, Sousa C. Detection of gluten immunogenic peptides in the urine of patients with coeliac disease reveals transgressions in the gluten-free diet and incomplete mucosal healing. Gut. 2017 Feb;66(2):250-257. doi: 10.1136/gutjnl-2015-310148. Epub 2015 Nov 25. **PMID:** 26608460 **Citation:** Comino I, Real A, Vivas S, Siglez MA, Caminero A, Nistal E, Casqueiro J, Rodriguez-Herrera A, Cebolla A, Sousa C. Monitoring of gluten-free diet compliance in celiac patients by assessment of gliadin 33-mer equivalent epitopes in feces. Am J Clin Nutr. 2012 Mar;95(3):670-7. doi: 10.3945/ajcn.111.026708. Epub 2012 Jan 18. **PMID:** 22258271 **Citation:** Comino I, Fernandez-Banares F, Esteve M, Ortigosa L, Castillejo G, Fambuena B, Ribes-Koninckx C, Sierra C, Rodriguez-Herrera A, Salazar JC, Caunedo A, Marugan-Miguelsanz JM, Garrote JA, Vivas S, Lo Iacono O, Nunez A, Vaquero L, Vegas AM, Crespo L, Fernandez-Salazar L, Arranz E, Jimenez-Garcia VA, Antonio Montes-Cano M, Espin B, Galera A, Valverde J, Giron FJ, Bolonio M, Millan A, Cerezo FM, Guajardo C, Alberto JR, Rosinach M, Segura V, Leon F, Marinich J, Munoz-Suano A, Romero-Gomez M, Cebolla A, Sousa C. Fecal Gluten Peptides Reveal Limitations of Serological Tests and Food Questionnaires for Monitoring Gluten-Free Diet in Celiac Disease Patients. Am J Gastroenterol. 2016 Oct;111(10):1456-1465. doi: 10.1038/ajg.2016.439. Epub 2016 Sep 20. Erratum In: Am J Gastroenterol. 2017 Jul;112(7):1208. **PMID:** 27644734 **Citation:** Shan L, Molberg O, Parrot I, Hausch F, Filiz F, Gray GM, Sollid LM, Khosla C. Structural basis for gluten intolerance in celiac sprue. Science. 2002 Sep 27;297(5590):2275-9. doi: 10.1126/science.1074129. **PMID:** 12351792 **Citation:** Moron B, Bethune MT, Comino I, Manyani H, Ferragud M, Lopez MC, Cebolla A, Khosla C, Sousa C. Toward the assessment of food toxicity for celiac patients: characterization of monoclonal antibodies to a main immunogenic gluten peptide. PLoS One. 2008 May 28;3(5):e2294. doi: 10.1371/journal.pone.0002294. **PMID:** 18509534 **Citation:** van Doorn RK, Winkler LM, Zwinderman KH, Mearin ML, Koopman HM. CDDUX: a disease-specific health-related quality-of-life questionnaire for children with celiac disease. J Pediatr Gastroenterol Nutr. 2008 Aug;47(2):147-52. doi: 10.1097/MPG.0b013e31815ef87d. **PMID:** 18664865 **Citation:** Varni JW, Burwinkle TM, Seid M. The PedsQL 4.0 as a school population health measure: feasibility, reliability, and validity. Qual Life Res. 2006 Mar;15(2):203-15. doi: 10.1007/s11136-005-1388-z. **PMID:** 16468077 **Citation:** Silvester JA, Graff LA, Rigaux L, Walker JR, Duerksen DR. Symptomatic suspected gluten exposure is common among patients with coeliac disease on a gluten-free diet. Aliment Pharmacol Ther. 2016 Sep;44(6):612-9. doi: 10.1111/apt.13725. Epub 2016 Jul 22. **PMID:** 27443825 **Citation:** Lebwohl B, Sanders DS, Green PHR. Coeliac disease. Lancet. 2018 Jan 6;391(10115):70-81. doi: 10.1016/S0140-6736(17)31796-8. Epub 2017 Jul 28. **PMID:** 28760445 **Citation:** Ludvigsson JF, Ciacci C, Green PH, Kaukinen K, Korponay-Szabo IR, Kurppa K, Murray JA, Lundin KEA, Maki MJ, Popp A, Reilly NR, Rodriguez-Herrera A, Sanders DS, Schuppan D, Sleet S, Taavela J, Voorhees K, Walker MM, Leffler DA. Outcome measures in coeliac disease trials: the Tampere recommendations. Gut. 2018 Aug;67(8):1410-1424. doi: 10.1136/gutjnl-2017-314853. Epub 2018 Feb 13. **PMID:** 29440464 ## Document Section ### Large Document Module #### Large Docs - Date: 2019-04-30 - Filename: Prot_004.pdf - Has ICF: False - Has Protocol: True - Has SAP: False - Label: Study Protocol - Size: 406820 - Type Abbrev: Prot - Upload Date: 2019-06-04T12:18 - Date: 2020-03-26 - Filename: ICF_006.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 662677 - Type Abbrev: ICF - Upload Date: 2020-04-10T08:56 ## Annotation Section ### Unposted Annotation #### Event: RELEASE - Date: 2022-06-22 - Date Unknown: Unknown #### Event: RESET - Date: 2023-03-31 - Date Unknown: Unknown ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: HIGH - As Found: Intestinal Diseases - ID: M7255 - Name: Digestive System Diseases - Relevance: HIGH - As Found: Digestive System Diseases - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: HIGH - As Found: Gastrointestinal Diseases - ID: M5696 - Name: Celiac Disease - Relevance: HIGH - As Found: Celiac Disease - ID: M11278 - Name: Malabsorption Syndromes - Relevance: HIGH - As Found: Malabsorption Syndromes - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life ### Condition Browse Module - Meshes - ID: D000002446 - Term: Celiac Disease - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000008286 - Term: Malabsorption Syndromes ### Misc Info Module #### Submission Tracking - Estimated Results First Submit Date: 2022-06-22 ##### Submission Infos - MCP Release N: Unknown - Release Date: 2022-06-22 - Reset Date: 2023-03-31 - Unrelease Date: Unknown - Unrelease Date Unknown: Unknown - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02946879 **Brief Title:** Long-Term Follow-Up Gene Therapy Study for Leber Congenital Amaurosis OPTIRPE65 (Retinal Dystrophy Associated With Defects in RPE65) **Official Title:** Long-term Follow-up Study of Participants Following an Open Label, Multi-centre, Phase I/II Dose Escalation Trial of an Adeno-associated Virus Vector (AAV2/5-OPTIRPE65) for Gene Therapy of Adults and Children With Retinal Dystrophy Owing to Defects in RPE65 (LCA2) #### Organization Study ID Info **ID:** MGT004 #### Organization **Class:** INDUSTRY **Full Name:** MeiraGTx UK II Ltd #### Secondary ID Infos **ID:** 2016-000898-20 **Type:** EUDRACT_NUMBER ### Status Module #### Completion Date **Date:** 2023-07 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-04-11 **Type:** ACTUAL **Last Update Submit Date:** 2024-04-10 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-07 **Type:** ACTUAL #### Start Date **Date:** 2016-11 **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2016-10-27 **Type:** ESTIMATED **Study First Submit Date:** 2016-07-22 **Study First Submit QC Date:** 2016-10-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** MeiraGTx UK II Ltd #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study is a longer-term follow-up study for patients who have been administered AAV2/5-OPTIRPE65 in the Phase I/II, open label, non-randomised, two-centre, dose escalation trial in adults and children with retinal dystrophy associated with defects in RPE65. **Detailed Description:** The follow up study is designed to collect data on longer-term safety and efficacy of AAV2/5-OPTIRPE65 administration in the OPTIRPE65 trial. ### Conditions Module **Conditions:** - Leber Congenital Amaurosis (LCA) - Eye Diseases - Eye Diseases, Hereditary - Retinal Diseases ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 15 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** subretinal administration of a single low dose of AAV RPE65 **Intervention Names:** - Biological: AAV OPTIRPE65 **Label:** Low dose AAV OPTIRPE65 #### Arm Group 2 **Description:** subretinal administration of a single intermediate dose of AAV RPE65 **Intervention Names:** - Biological: AAV OPTIRPE65 **Label:** Intermediate dose AAV OPTIRPE65 #### Arm Group 3 **Description:** subretinal administration of a single highdose of AAV RPE65 **Intervention Names:** - Biological: AAV OPTIRPE65 **Label:** High dose AAV OPTIRPE65 ### Interventions #### Intervention 1 **Arm Group Labels:** - High dose AAV OPTIRPE65 - Intermediate dose AAV OPTIRPE65 - Low dose AAV OPTIRPE65 **Description:** comparison of different doses of AAV RPE65 **Name:** AAV OPTIRPE65 **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Safety is defined as the absence of ATIMP-related safety events **Measure:** Incidence of Adverse Events related to the treatment **Time Frame:** 5 years #### Secondary Outcomes **Description:** Improvements in visual function as assessed by visual assessment **Measure:** Improvement in the retinal function **Time Frame:** 5 years **Description:** Improvements in retinal function as assessed by visual assessment **Measure:** Improvement in the visual function **Time Frame:** 5 years **Description:** Improvement in the participant's quality of life which is measurable by QoL questionnaire **Measure:** Improvement in quality of life **Time Frame:** 5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Were enrolled and treated in the prior open-label, Phase I/II, dose escalation study involving intraocular administration of AAV2/5-OPTIRPE65 Exclusion Criteria: * Individuals will be excluded if they are unwilling or unable to meet with the requirements of the study. **Maximum Age:** 100 Years **Minimum Age:** 3 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** The patient population are those with Leber Congenital Amaurosis (LCA) with gene mutation RPE65 who have participated in the OPTIRPE65 trial. ### Contacts Locations Module #### Locations **Location 1:** **City:** Ann Arbor **Country:** United States **Facility:** Kellogg Eye Center, University of Michigan Health **State:** Michigan **Zip:** 48105 **Location 2:** **City:** London **Country:** United Kingdom **Facility:** Moorfields Eye Hospital NHS Foundation Trust ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012162 - Term: Retinal Degeneration - ID: D000014786 - Term: Vision Disorders - ID: D000012678 - Term: Sensation Disorders - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M8271 - Name: Eye Diseases - Relevance: HIGH - As Found: Eye Disease - ID: M14999 - Name: Retinal Diseases - Relevance: HIGH - As Found: Retinal Disease - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M29107 - Name: Retinal Dystrophies - Relevance: HIGH - As Found: Retinal Dystrophy - ID: M18339 - Name: Eye Diseases, Hereditary - Relevance: HIGH - As Found: Eye Diseases, Hereditary - ID: M28730 - Name: Leber Congenital Amaurosis - Relevance: HIGH - As Found: Leber Congenital Amaurosis - ID: M5047 - Name: Blindness - Relevance: HIGH - As Found: Amaurosis - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: HIGH - As Found: Diseases, Hereditary - ID: M14997 - Name: Retinal Degeneration - Relevance: LOW - As Found: Unknown - ID: M17530 - Name: Vision Disorders - Relevance: LOW - As Found: Unknown - ID: M15490 - Name: Sensation Disorders - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: T3335 - Name: Leber Congenital Amaurosis - Relevance: HIGH - As Found: Leber Congenital Amaurosis - ID: T3344 - Name: Leber Congenital Amaurosis 2 - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001766 - Term: Blindness - ID: D000005128 - Term: Eye Diseases - ID: D000012164 - Term: Retinal Diseases - ID: D000058499 - Term: Retinal Dystrophies - ID: D000057130 - Term: Leber Congenital Amaurosis - ID: D000015785 - Term: Eye Diseases, Hereditary - ID: D000030342 - Term: Genetic Diseases, Inborn ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03069079 **Acronym:** GOSH **Brief Title:** Investigation of Dental Health in Children With Neutrophil Defects: A Clinical Study **Official Title:** Investigation of Dental Health in Children With Neutrophil Defects: A Clinical Study #### Organization Study ID Info **ID:** COCR0004 #### Organization **Class:** OTHER **Full Name:** Queen Mary University of London #### Secondary ID Infos **Domain:** QMUL R and D **ID:** 011374 **Type:** REGISTRY **Domain:** UK REC **ID:** 15/LO/1090 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2019-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-11-14 **Type:** ACTUAL **Last Update Submit Date:** 2022-11-10 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2018-12 **Type:** ACTUAL #### Start Date **Date:** 2016-12 **Status Verified Date:** 2016-12 #### Study First Post Date **Date:** 2017-03-03 **Type:** ACTUAL **Study First Submit Date:** 2017-01-17 **Study First Submit QC Date:** 2017-03-01 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Great Ormond Street Hospital for Children NHS Foundation Trust #### Lead Sponsor **Class:** OTHER **Name:** Queen Mary University of London #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Title: Investigation of neutrophil defects associated with periodontal disease and tooth loss in children. A clinical study. Objectives: The primary objective of this study is: * To investigate presence of periodontal disease and response to periodontal treatment in children affected by neutrophil defects The secondary objectives of this study are: * To investigate presence of other dental diseases in children affected by neutrophil defects * To assess oral microbiological and inflammatory parameters in children affected by neutrophil defects Primary outcomes: The primary outcomes are (a) presence of periodontal disease as assessed by clinical factors: probing pocket depth, attachment level, bleeding on probing and radiographic bone loss) (b) microbiological and host response factors: detected in periodontal pockets and gingival crevicular fluid and (c) response to treatment Study sample: Children affected by neutrophil defects and meeting outlined inclusion and exclusion criteria Number of participants: 50 children Study design: This is a longitudinal treatment study. All participants will attend for 4-7 visits during the study as outlined below: * Screening visit (visit 1): consent procedure, dental examination, saliva and plaque sampling * Baseline visit (visit 2):, detailed periodontal examination, dental radiographs, sampling of gingival crevicular fluid and, if appropriate scaling, polishing and oral hygiene instructions * Non-surgical periodontal treatment (visit 3A to 3D, max 4 sessions): oral hygiene instructions and supra- and sub-gingival debridement (under local anaesthesia if necessary) * Follow-up Visit (visit 4, 4th to 7th visit) (six months following treatment): detailed dental examination, oral hygiene instructions, sampling of saliva, subgingival plaque and gingival crevicular fluid, tooth scaling and polishing. **Detailed Description:** 1. BACKGROUND Primary immunodeficiency diseases (PIDs) are a group of rare inherited disorders that are estimated to affect approximately 1 in 2,000 children. In PIDs there is an intrinsic defect in the human immune system, such as a failure to produce enough antibodies to fight infection, or a failure in the cellular defences against infection . These conditions usually manifest themselves early in life and are often life-threatening. Rarer, severe forms of PIDs present in childhood with serious infections and are often associated with additional autoimmune and inflammatory complications. Periodontal diseases are inflammatory diseases of the gingivae (gums) due to an imbalance in the host response to subgingival bacteria and are associated with destruction of the supporting tissues of the teeth and early loss of the dentition and masticatory function. While periodontitis and its non-destructive partner condition, gingivitis (reversible plaque-induced gingival inflammation), are very common, the prevalence of periodontitis in the primary dentition and in the second decade of life appears very low, ranging from 0.1% to 1%. This prevalence increases dramatically in children affected by PIDs, to the point that periodontitis is considered a common feature of syndromic genetic conditions due to single gene defects affecting the host response, such as leukocyte adhesion deficiency (LAD), severe congenital neutropenia, cyclic neutropenia and Chediak-Higashi syndrome. Children with defects in neutrophil activity seem particularly susceptible to develop severe periodontitis, due to the important defensive role of neutrophils against periodontopathogenic bacteria. In such cases, both primary and permanent dentitions are affected, with a devastating effect on mastication, aesthetics and quality of life, also owing to the lack of reliable restorative solutions. Furthermore, oral diseases (in particular periodontitis) may also provide an additional systemic inflammatory burden for these subjects. This could occur since periodontal bacteria have been shown to enter the systemic circulation from inflamed gum tissues even during normal tooth brushing, have been found in atheromatous plaques and in the amniotic fluid of pregnant women. The treatment of periodontitis involves a non-specific reduction of the bacterial load below the gingival margin, achieved by oral hygiene instructions and non-surgical periodontal therapy (NSPT). More advanced cases need antibiotics, surgical treatment or extractions. In children with PID the response to this treatment is highly variable and the presence of periodontitis often leads to early tooth loss, adding to the poor quality of life of sufferers. Incorporation of periodontal screening has been advocated for early diagnosis and treatment of periodontal diseases in all children and especially for children with neutrophil defects, in order to prevent disease progression and tooth loss. However, most published papers on periodontitis in children with immunodeficiencies are case reports or familial observations or reviews. Therefore, there's a lack of well-designed studies investigating both the prevalence of periodontitis and oral diseases in general in children with neutrophil defects and their response to treatment. In particular, it is not clear which factors determine the onset of periodontitis in a subset of children with PID. Such factors may range from the composition of the subgingival microbiota, the immunological reaction against these bacteria, to the inflammatory response in the periodontium. A better understanding of the causative factors may help in early diagnosis and treatment, reducing the burden on affected children. 2. AIMS AND OBJECTIVES The hypotheses behind this study are that: i) Specific microbiological and host response parameters dictate severity of periodontal diseases and associated risk of early tooth loss in children suffering from neutrophil defects ii) Periodontal treatment in children with neutrophil defects and periodontitis can lead to an improvement in their oral health (reduction in periodontal pockets and bleeding scores), which would reduce their risk of tooth loss and potentially improve their future quality of life. Therefore, the aims of this study are to offer specialist periodontal assessment and treatment to children with neutrophil defects, to determine the impact of neutrophil defects upon gingival health and to assess their response to periodontal therapy. This will facilitate the development of novel therapeutic management pathways specific for these conditions, and will determine whether there is a need for specific care protocols with a consequent improvement in tooth retention, quality of life and systemic health. * The primary objective of this study is: - To investigate presence of periodontal disease and response to periodontal treatment in children affected by neutrophil defects * The secondary objectives of this study are: * To investigate presence of other dental diseases in children affected by neutrophil defects * To assess oral microbiological and host response parameters in children affected by neutrophil defects. 3. STUDY DESIGN 3.1 Overall study plan This is an exploratory longitudinal study. Fifty children affected by neutrophil defects potentially affecting the periodontium will be identified from subjects attending the Immunology and Haematology clinics at Great Ormond Street Hospital (GOSH), following a medical examination. All children will undergo a dental examination by a qualified dentist currently completing specialist training in periodontology. Children will also provide samples of gingival crevicular fluid (GCF) and subgingival plaque. Following the baseline, non-surgical periodontal therapy will be provided as necessary and participants will be followed-up and re-examined up to 6 months after treatment. 4. STUDY POPULATION 4.1 Participant Selection Fifty children affected by neutrophil defects and under care at Great Ormond Street Hospital (GOSH) and meeting the inclusion criteria will participate in the study. Most children attend GOSH regularly (at least 6-monthly) for review/treatment planning appointments (seen by Dr Ancliff or Dr Worth). The parents/guardians of potentially suitable children will be initially contacted by letter prior to their attendance at GOSH. Every invitation will be followed up by a telephone call to discuss any issues and enquiry about willingness to participate. When possible, upon parents' agreement about study participation, patients could be enrolled and undergo the screening visit on the same day as their routine GOSH visit (this would save on extra travel for patients living outside London). Alternatively, they will be offered another appointment. All the study visits will take place at GOSH. QMULwill only serves as the sponsor and coordinating centre for this study. . 5. STUDY VISITS Study visits include baseline, non-surgical periodontal therapy and follow-ups. All visits will be carried out at Great Ormond Street Hospital. 5.1 Visit 1 (Screening) o Informed consent o Collection of data on clinical and laboratory diagnosis, time of diagnosis, previous and current systemic treatment and on any previous dental treatment o Basic Periodontal Examination (BPE) and assessment of caries (DMFT) and mucosal diseases o Saliva and plaque sample * Clinical photographs * Treatment plan All children found to have BPE scores of 1 (gingival bleeding), 2 (presence of calculus), 3 or 4 (presence of gingival pockets) will be offered the possibility to enter the treatment phase of the study (from visit 2 onwards), which will be provided at GOSH. Children found not to be affected by periodontal diseases will be offered the possibility to be seen at GOSH for visit 2 only, if they wish so. 5.2 Visit 2 (Baseline and first treatment session- ± 28 days) o Recording of any adverse events (AE or concomitant medication) * Full periodontal examination including collection of periodontal measurements (and dental radiographs if appropriate) * Gingival crevicular fluid (GCF) sample * Session of tooth scaling, oral hygiene and polishing All children found to require further treatment will need to attend an additional 1 to 4 treatment sessions at GOSH as detailed below: 5.3 Visit 3A to 3D (treatment, within 2 months of visit 1, from 1 to 4 visits) Update medical history, check adverse events, non-surgical periodontal therapy (maximum 4 sessions): oral hygiene instructions and supra- and sub-gingival debridement. 5.4 Visit 4 (last follow-up, 6 months after last treatment visit ± 21 days) Update medical history, check adverse events, dental examination and collection of periodontal measurements, perform oral hygiene instructions, sampling of saliva, subgingival plaque and gingival crevicular fluid, tooth scaling and polishing (if needed). 5.5 Medical and dental history A complete medical and dental history will be obtained during screening and confirmed during the baseline visit. Information on previous medical tests and status of current treatment will be obtained by the treating GOSH physician. The histories will include demographic background information, ethnicity, systemic and dental status information. 5.6 Concomitant medications All concomitant medications will be recorded throughout the study. 5.7 Periodontal examination At the screening visit, a Basic Periodontal Examination (BPE) will be performed, consisting of gentle probing between teeth and gums on index teeth (UR6, UR1, UL6, LL6, LL1 and LR6 or URd,URc,ULd,LLD,LLc,LRd) to identify presence of gum disease. A number between 0 (health) and 4 (gingival pocket\>5mm) will be recorded for each quadrant. The dmft/ DMFT (decayed missing filled teeth) index will be used for recording caries experience. Mucosal status will be investigated by recording presence of ulcers, blisters, white patches, speckled areas and masses. Saliva samples and plaque samples will be collected. At the baseline visit, a calibrated dental examiner will perform a more detailed assessment, consisting of collection of full-mouth measurements of probing pocket depth (PPD), clinical attachment level (CAL), gingival bleeding on probing gingival crevicular fluid sampling and assessment of plaque levels (simplified visible biofilm index). 5.8 Dental sampling A series of samples will be collected from the patients' oral cavity (sample of saliva, GCF and subgingival plaque biofilm). GCF will be taken by gentle insertion of 4 paper-strips in the gingival crevice of the mesio-buccal aspect of 4 teeth (3 first molars and 1 incisor). Subgingival plaque will be collected by the examiners following gentle insertion of a curette at the base of 3 first molars and 1 first incisor sites (one in each quadrant). In case of absence of permanent molars, the samples will be collected from the second deciduous molars. The 4 subgingival samples will be pooled together. 5.9 Definition of periodontal disease Following the periodontal examination, children will be diagnosed as: - Healthy: no attachment loss (measured as no CAL\>3mm or CAL\>3mm in \<2 non-adjacent teeth) and no/minimal gingival inflammation (measured as \<15 sites bleeding on probing) - Gingivitis: no attachment loss (measured as no CAL\>3mm or CAL\>3mm in \<2 non-adjacent teeth) and presence of gingival inflammation (≥15 sites bleeding on probing) - Periodontitis: attachment loss (measured as CAL\>3mm in ≥2 non-adjacent teeth) 5.10 Dental radiographs If a BPE code 3 or more is detected, bite-wings or long cone parallel periapical radiographs (more indicated for a BPE of 4) using Rinn holders will be taken to detect marginal bone levels, according to clinical needs. The distance between coronal and apical bone levels and cemento-enamel junction will be analysed as described previously, also taking into account age of the patient, tooth eruption stage and presence of primary, mixed or permanent dentition. Radiographs will then be digitized for future analysis using an image-analysis software. 5.11 Non-surgical periodontal treatment All children will be offered an oral hygiene and tooth scaling and polishing session. For children affected by periodontal disease, subgingival debridement will also be performed according to needs, with the aim to disrupt the subgingival biofilm responsible for the onset and progression of the periodontal pathology. This can be accompanied, when appropriate, by the use of local anaesthesia and adjunctive antimicrobials (systemic or locally applied subgingivally), according to the clinical presentation and the child's medical conditions. In addition, when required, nitrous oxide sedation (NOS) could be used before treatment. NOS is a safe and widely-used technique in paediatric dentistry. It is administered by inhalation via a nasal mask and is used to reduce dental anxiety along with behaviour management techniques. There are very few contra-indications. It is not suitable for patients who have nasal congestion or severe dental anxiety. NOS will be conducted following the guidelines by Standards for Conscious Sedation in the Provision of Dental Care and appropriate clinical consent forms will be obtained before its use. Accurate supra- and sub-gingival removal of calculus and dental plaque will be performed both with ultrasonic and/or manual instruments. The necessary sub-gingival debridement will be performed in 1 to 4 visits (either full mouth treatment, half-mouth treatment or quadrant-wise treatment) depending on patient preference and practical considerations, using manual (Gracey curettes, Hu-Friedy) and ultrasonic devices (EMS). Caries will be treated as necessary (shared care with the general dental practitioners / community dental services). Children with mucosal lesions requiring treatment will be given a letter for their GDP suggesting referral to a collaborating expert in Oral Medicine (Prof. Stephen Porter). 6. Missing data The inclusion of very young subjects in the present study introduces the risk of missing data, owing to the difficulty in data and sample collection in some children (due to their unwillingness to be examined or sampled). The Investigators will endeavor to complete data and sample collection with minimal discomfort to each subject. However, should dental and periodontal examination not be achievable, the subjects will be exited from the study. Once the main variable outcome of the study (presence of periodontal disease by means of collection of BPE) is recorded, the subject will not be excluded from analysis, even if some of the other data are not collected. For example, if a child tolerated periodontal probing (hence collection of BPE) but refuses to provide a plaque sample, he/she will still be included in the study until the last visit. The final study analyses and report/publications will take into account possible missing data and reasons why they were not collected. 5.7 Repeatability Prior to initiation of the study, the designated examiner will participate in a training and repeatability exercise. For the repeatability exercise, the examiner will score 5 subjects for PPD and REC and then perform repeated examinations of the same subjects on the same day after at least 15 minutes separation. Upon completion of all measurements, intra-examiner repeatability for PPD measurements will be assessed. The reproducibility of the examiner will be tested using the Bland-Altman approach and by calculating Lin's concordance correlation coefficient. A co-efficient of repeatability less than ± 2 mm in 95% of the cases is considered acceptable. 5.8 Laboratory analyses Samples will initially be stored at -70° to -80° for analysis. Microbiological analysis will involve next generation sequencing of the 16S rRNA metagenome at QMUL. GCF samples will be eluted and will undergo analysis of inflammatory markers as described before. 9. PARTICIPANTS' COMPLETION AND WITHDRAWAL 9.1Reasons for withdrawal Participants will be informed that they have the right to withdraw from the study at any time for any reason, without prejudice to their medical care. The investigator also has the right to withdraw participants from the study for any of the following reasons: * Occurrence of an unacceptable adverse event/illness * Participant/parent/guardian request * Protocol violations * Administrative reasons * Failure to return for follow-up * General or specific changes in the Participant's condition unacceptable for further treatment in the judgment of the investigator 9.2 Completion/Withdrawal Procedures At the time of withdrawal, all study procedures outlined for the end of study visit should be concluded. The primary reason for a participant's withdrawal from the study is to be recorded on the CRF. 10. ADVERSE EVENT REPORTING 7.1 Adverse Events (AEs) An adverse event includes any noxious, pathological or unintended change in anatomical, physiological or metabolic functions as indicated by physical signs, symptoms and/or laboratory changes occurring in any phase of the clinical study, whether associated with the study or not. This includes exacerbation of pre-existing conditions or events, inter-current illnesses, drug interaction or the significant worsening of the disease under study. For all adverse events, the investigator must pursue and obtain information adequate both to determine the outcome of the adverse event and to assess whether it meets the criteria for classification as a serious adverse event requiring immediate notification to the sponsor or its designated representative. For all adverse events, sufficient information should be obtained by the investigator to determine the causality of the adverse event. Clinically significant symptoms following NSPT include those that are outside a normally accepted range (as judged by the clinician). This would include: * Excessive or progressively increasing pain or discomfort * Excessive swelling * Signs of infection (e.g. suppuration) * Excessive bleeding Moreover we shall record if the participants take any drugs as a result of these adverse events. 7.2 Serious Adverse Events definition A serious adverse event or serious adverse drug reaction is any untoward medical occurrence at any dose which: * results in death * is life-threatening (immediate risk of death) * requires participant hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * results in congenital anomaly/birth defect. Medical and scientific judgment should be exercised in determining whether an event is an important medical event. An important medical event may not be immediately life-threatening and/or result in death or hospitalization. However, if it is determined that the event may jeopardize the participant and may require intervention to prevent one of the other outcomes listed in the definition above, the important medical event should be reported as serious. 7.3 Reporting of Serious Adverse Events Because of the need to report to health authorities all suspected unexpected serious adverse reactions (SUSARs) in a timely manner, it is vitally important that the investigator reports immediately any adverse events which would be considered serious. Any serious adverse event (including death) due to any cause, which occurs during the course of this clinical study, whether or not related to the study, must be reported immediately to the Principal Investigator or its designee. 7.4 Reporting period The nature of each individual adverse event, date and time of onset, duration, severity and relationship to treatment and corrective treatment must be established by the investigator and recorded in the CRF. Adverse events will be recorded following signing of the first consent form up to the last study visit. Any serious adverse event occurring any time after the reporting period must be promptly reported if a causal relationship to the investigational product is suspected and all SUSARs will be followed up until resolution. 8 STATISTICAL PROCEDURES 6.1 Sample size estimation A convenience sample of 50 children (based on current estimation of numbers of children with neutrophil defects seen yearly at GOSH) is proposed for this study, since no formal power calculation could be performed owing to the lack of similar studies in the literature. However, hypothesising that subgingival presence of bacterium A.actinomycetemcomitans at baseline could discriminate between responders and non-responders to periodontal treatment (difference 0.5mm ± 0.5 mm mean clinical attachment gain), 41 children (including 20% drop-outs) who undergo periodontal therapy would give 80% power to prove or disprove this hypothesis. 6.2 Statistical analysis All data derived from the study will be anonymised and entered in a dedicated database. The initial plan of analysis will describe the prevalence of periodontal diseases in the study cohort (divided by medical diagnosis). Appropriate summary statistics will be determined separately for affected and non-affected subjects. Differences in demographic and systemic parameters (diagnosis, current treatment) between affected and non-affected subjects will be assessed by the two-sample t-test or Mann-Whitney test as appropriate. Explorative logistic regression analyses will be performed to detect the effect of microbiological and inflammatory parameters (e.g. presence of periodontopathogenic bacterium A.actinomycetemcomitans or cytokine concentrations in the GCF) on groups, taking into account that many children may be on long-term antimicrobial therapy. Response to therapy will be assessed by comparing clinical periodontal parameters at baseline and follow-ups by random effects analysis taking time points as repeated measures. This will be then associated to patients' demographics, compliance and microbiological and inflammatory factors. 7 ADMINISTRATIVE REQUIREMENTS 9.1 Good clinical practice The study will be conducted in accordance with the International Conference on Harmonisation (ICH) for Good Clinical Practice (GCP) and the appropriate regulatory requirement(s). Essential clinical documents will be maintained to demonstrate the validity of the study and the integrity of the data collected. Master files should be established at the beginning of the study, maintained for the duration of the study, and retained according to the appropriate regulations. 9.2 Ethical considerations The study will be conducted in accordance with ethical principles founded in the Declaration of Helsinki. The Research Ethics Committee will review all appropriate study documentation in order to safeguard the rights, safety, and well-being of the participants. The study will be conducted only at sites where Research Ethics Committee approval has been obtained. The protocol, informed consent, advertisements (if applicable), written information given to the participants, safety updates, progress reports, and any revisions to these documents will be provided to the Research Ethics Committee by the investigator. 9.3 Participant Information and Informed Consent During the first screening session and the enrolment visit, written informed consent will be obtained from all participants/guardians/parents. The method of obtaining and documenting the informed consent and the contents of the consent will comply with ICH-GCP and all applicable regulatory requirement(s). 9.4 Participant confidentiality In order to maintain participant privacy, all CRFs, study reports and communications will identify the participant by initials and the assigned participant number. The participant's confidentiality will be maintained and will not be made publicly available to the extent permitted by the applicable laws and regulations. 9.5 Protocol compliance The investigator will conduct the study in compliance with the protocol and given approval/favorable opinion by the Research Ethics Committee and the appropriate regulatory authority(ies). Changes to the protocol will require written Research Ethics Committee approval/favourable opinion prior to implementation, except when the modification is needed to eliminate an immediate hazard(s) to participants. 9.6 Study monitoring Monitoring and auditing procedures developed by the investigator will be followed, in order to comply with GCP guidelines. On-site checking of the CRFs for completeness and clarity, cross-checking with source documents, and clarification of administrative matters will be performed. The study will be monitored by a clinical trial coordinator or its designee. 9.7 Case report form completion Case report forms will be completed for each study participant. It is the investigator's responsibility to ensure the accuracy, completeness, and timeliness of the data reported in the participant's CRF. Source documentation supporting the CRF data should indicate the participant's participation in the study and should document the dates and details of study procedures, adverse events and participant status. The investigator, or designated representative, should complete the CRF pages as soon as possible after information is collected, preferably on the same day that a study participant is seen for an examination, treatment, or any other study procedure. Any outstanding entries must be completed immediately after the final examination. An explanation should be given for all missing data. The investigator must sign and date the Investigator's Statement at the end of the CRF to endorse the recorded data. 9.8 Premature closure of the study This study may be prematurely terminated, if in the opinion of the investigator there is sufficient reasonable cause. Written notification, documenting the reason for study termination, will be provided to the investigator by the terminating party. Circumstances which may warrant termination include, but are not limited to: * Determination of unexpected, significant, or unacceptable risk to participants * Failure to enter participants at an acceptable rate * Insufficient adherence to protocol requirements * Insufficient data 9.9 Complaints and indemnity * Complaints. In the event of complaint about the conduct of the study, the hosting NHS- Great Ormond Street Hospital for Children NHS Foundation - complaints policy should apply as the research subject is recruited through an NHS Trust. * Indemnity QMUL holds insurance against claims from participants for harm caused by their participation in this clinical study. Participants may be able to claim compensation if they can prove that QMUL has been negligent. However, if this clinical study is being carried out in a hospital, the hospital continues to have a duty of care to the participant of the clinical study. QMUL does not accept liability for any breach in the hospital's duty of care, or any negligence on the part of hospital employees. This applies whether the hospital is an NHS Trust or otherwise. ### Conditions Module **Conditions:** - Primary Immune Deficiency Disorder - Periodontitis **Keywords:** - primary immunodeficiency - dental health - neutrophil defect - periodontitis ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All children will be offered an oral hygiene and tooth scaling and polishing session. For children affected by periodontal disease, subgingival debridement will also be performed according to needs, with the aim to disrupt the subgingival biofilm responsible for the onset and progression of the periodontal pathology. This can be accompanied, when appropriate, by the use of local anaesthesia and adjunctive antimicrobials (systemic or locally applied subgingivally), according to the clinical presentation and the child's medical conditions. In addition, when required, nitrous oxide sedation (NOS) could be used before treatment. Caries will be treated as necessary (shared care with the general dental practitioners / community dental services). Children with mucosal lesions requiring treatment will be given a letter for their GDP suggesting referral to a collaborating expert in Oral Medicine (Prof. Stephen Porter). **Intervention Names:** - Procedure: Oral hygiene advice, non surgical periodontal treatment **Label:** Non surgical Periodontal therapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Non surgical Periodontal therapy **Description:** For children affected by periodontal disease, oral hygiene advice, non surgical periodontal treatment will also be performed according to needs. This can be accompanied, when appropriate, by the use of local anaesthesia and adjunctive antimicrobials (systemic or locally applied subgingivally), according to the clinical presentation and the child's medical conditions. Accurate supra- and sub-gingival removal of calculus and dental plaque will be performed both with ultrasonic and/or manual instruments. The necessary sub-gingival debridement will be performed in 1 to 4 visits (either full mouth treatment, half-mouth treatment or quadrant-wise treatment) depending on patient preference and practical considerations, using manual (Gracey curettes, Hu-Friedy) and ultrasonic devices (EMS). . **Name:** Oral hygiene advice, non surgical periodontal treatment **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Measurement periodontal pocket depth at baseline (in millimetres, mm) **Measure:** Probing pocket depth **Time Frame:** At baseline only (0 months) **Description:** Measurement of attachment level at baseline (in millimetres, mm) **Measure:** Attachment level **Time Frame:** At baseline only (0 months) **Description:** Proportion of bleeding sites on probing at baseline (in percentage, %) **Measure:** Bleeding on probing **Time Frame:** At baseline only (0 months) **Description:** Proportion of bone loss in relation to total root length at baseline. (in percentage, %) **Measure:** Radiographic bone loss **Time Frame:** At baseline only (0 months) **Description:** Microbiological analysis with next generation sequencing of the 16s rRNA metagenome at baseline. (Proportion of specified microbes present in sample at baseline) **Measure:** Microbiological assay **Time Frame:** At baseline only (0 months) **Description:** Gingival crevicular fluid inflammatory markers (Proportion specified inflammatory markers present in sample at baseline) **Measure:** GCF **Time Frame:** At baseline only (0 months) #### Secondary Outcomes **Description:** Change in periodontal pocket depth at baseline to follow-up (in millimetres, mm) **Measure:** Response to treatment: Probing pocket depth **Time Frame:** From baseline (0 months) to follow-up (24 months) **Description:** Change in proportion of bleeding sites on probing at baseline to follow-up (in percentage, %) **Measure:** Response to treatment: Attachment level **Time Frame:** From baseline (0 months) to follow-up (24 months) **Description:** Change in proportion of bleeding sites on probing at baseline to follow-up (in percentage, %) **Measure:** Response to treatment: Bleeding on probing **Time Frame:** From baseline (0 months) to follow-up (24 months) **Description:** Change in proportion of specified microbes present in sample at baseline to follow-up **Measure:** Response to treatment: Microbiological assay **Time Frame:** From baseline (0 months) to follow-up (24 months) **Description:** Change in proportion specified inflammatory markers present in sample at baseline to follow-up **Measure:** Response to treatment: GCF **Time Frame:** From baseline (0 months) to follow-up (24 months) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria Each participant must meet the following inclusion criteria to be enrolled in the study: 1. Age 4-16 years 2. Diagnosis of one of the following neutrophil defects (as confirmed by the treating physician): * Disorders of neutrophil numbers * Cyclic neutropenia * Congenital neutropenia * Severe Congenital Neutropoenia * X-linked Neutropoenia * Disorders of neutrophil function * Leucocyte Adhesion Defect s * Other neutrophil disorders/ undefined neutrophil disorders (functional defects demonstrated on testing but genetic basis not yet known) * Combined immunodeficiency syndromes * Wiskott Aldrich Syndrome * Hyper IgM Syndrome * Chediak Higashi Syndrome * Undefined combined immunodeficiency (functional defects demonstrated on testing but genetic basis not yet known) 3. Participants/parents/guardians willing to sign the informed consent Exclusion Criteria Participants will not be eligible for participation in the study if unwilling to be examined or unable to return for follow-up appointments. **Maximum Age:** 16 Years **Minimum Age:** 4 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** London **Country:** United Kingdom **Facility:** Center for Oral Clinical Research, Queen Mary, University of London **State:** Greater London **Zip:** E1 2AD **Location 2:** **City:** London **Country:** United Kingdom **Facility:** Dental and Maxillofacial Department, Great Ormond Street Hospital for Children **Zip:** WC1N 3JH #### Overall Officials **Official 1:** **Affiliation:** Queen Mary University of London **Name:** Luigi Nibali, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010510 - Term: Periodontal Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000007154 - Term: Immune System Diseases - ID: D000030342 - Term: Genetic Diseases, Inborn ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M13427 - Name: Periodontitis - Relevance: HIGH - As Found: Periodontitis - ID: M10199 - Name: Immunologic Deficiency Syndromes - Relevance: HIGH - As Found: Immune Deficiency Disorder - ID: M2285 - Name: Primary Immunodeficiency Diseases - Relevance: HIGH - As Found: Primary Immune Deficiency Disorder - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M13419 - Name: Periodontal Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010518 - Term: Periodontitis - ID: D000081207 - Term: Primary Immunodeficiency Diseases - ID: D000007153 - Term: Immunologic Deficiency Syndromes ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M12546 - Name: Nitrous Oxide - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00513279 **Brief Title:** To Investigate If Single Doses Of GSK618334 Are Safe And To Investigate Blood Levels Of GSK618334 **Official Title:** A First Time in Human, Blinded, Randomised, Placebo-Controlled, Two-cohort Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single Oral Escalating Doses of GSK618334 in Healthy Male Volunteers #### Organization Study ID Info **ID:** DBU107640 #### Organization **Class:** INDUSTRY **Full Name:** GlaxoSmithKline ### Status Module #### Completion Date **Date:** 2007-10-04 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-09-15 **Type:** ACTUAL **Last Update Submit Date:** 2017-09-14 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2007-10-04 **Type:** ACTUAL #### Start Date **Date:** 2007-06-28 **Type:** ACTUAL **Status Verified Date:** 2017-09 #### Study First Post Date **Date:** 2007-08-08 **Type:** ESTIMATED **Study First Submit Date:** 2007-08-06 **Study First Submit QC Date:** 2007-08-06 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** GlaxoSmithKline #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** GSK618334 is being developed as an innovative treatment for substance dependence and potentially other compulsive behavioral disorders. This study will evaluate the safety, tolerability and pharmacokinetics of single doses of GSK618334 in healthy volunteers. ### Conditions Module **Conditions:** - Substance Dependence **Keywords:** - Safety, - GSK618334 - pharmacokinetics, - repeat dose, - tolerability, - pharmacodynamics, - placebo, ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects in Cohort 1 will be randomized to one of the following sequences: ABDFH, BADFH, BDAFH, BDFAH and BDFHA in a 1:1:1:1:1 ratio where A = Placebo, B= GSK618334 dose 1 (2.5 mg), D = GSK618334 dose 3, F = GSK618334 dose 5, H = GSK618334 dose 7. On day 1, subjects will be administered a starting dose of 2.5 milligrams (mg) GSK618334. The planned doses of GSK618334 to be administered in Cohort 1 are 2.5, 25, 100 and 400mg. In each dosing period 2 subjects will receive placebo and 8 subjects will receive GSK618334. Subjects within a cohort will have a washout period of at least two weeks from last dose before receiving another dose. **Intervention Names:** - Drug: GSK618334 - Drug: GSK618334 matching placebo tablets **Label:** Cohort 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Subjects in Cohort 2 will be randomized to one of the following sequences: ACEGI, CAEGI, CEAGI, CEGAI, CEGIA in a 1:1:1:1:1 ratio where A = Placebo, C= GSK618334 dose 2, E = GSK618334dose 4, G = GSK618334 dose 6, I= GSK618334 dose 8. In each dosing period 2 subjects will receive placebo and 8 subjects will receive GSK618334. Subjects within a cohort will have a washout period of at least two weeks from last dose before receiving another dose. **Intervention Names:** - Drug: GSK618334 - Drug: GSK618334 matching placebo tablets **Label:** Cohort 2 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Cohort 1 - Cohort 2 **Description:** GSK618334 will be available as white to off-white coated tablets. GSK618334 will be swallowed with 250 milliliters (mL) of water. **Name:** GSK618334 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Cohort 1 - Cohort 2 **Description:** GSK618334 placebo tablets visually match the active GSK618334 tablets and contain the same excipients except for the omission of the active ingredient. GSK618334 matching placebo will be swallowed with 250 mL of water. **Name:** GSK618334 matching placebo tablets **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Safety measures: ECG, Vital Signs, Adverse Events **Time Frame:** for 48 hours after dosing. **Measure:** PK measures: Blood sampling for GSK598809 **Time Frame:** for up to 96hr post dose #### Secondary Outcomes **Measure:** Tests on cognition (thinking) **Time Frame:** for 48 hours after dosing **Measure:** Movement rating scales **Time Frame:** pre-dose, 2, 4 and 24 hours post-dose on Day 1 **Measure:** Prolactin, TSH and GH **Time Frame:** pre-dose, 1, 2, 4, 8 and 24 hours post-dose on Day 1 **Measure:** Psychological assessments **Time Frame:** pre-dose, up to 48 hours post-dose **Measure:** Cognitive/Impulsivity tests **Time Frame:** pre-dose, 2, 7 and 24 hours post-dose on Day 1 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy adult male subject, aged between 18 and 50 years of age inclusive. * Body weight ≥50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive. * Healthy as judged by a responsible physician. No clinically significant abnormality identified on the medical, psychiatric or laboratory evaluation, including 12-lead ECG and 24 hour Holter ECG. A subject with a clinical abnormality or laboratory parameter(s) outside the reference range for this age group may be included only if the Investigator considers the finding will not introduce additional risk factors and will not interfere with the study procedures. * Signed and dated written informed consent prior to participation in the study. * The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions. Exclusion Criteria: * The subject has a positive pre-study urine drug screen including alcohol at the screening visit and/or prior to receiving the first dose of study medication. Drugs that will be screened for are amphetamines, barbiturates, cocaine, opiates, cannabinoids, methadone, benzodiazepines, phencyclidine (PCP) and cotinine. If any of these tests are positive the investigator may re-test the subject and the subject may be included if the re-test is negative. * A positive pre-study Hepatitis B surface antigen, Hepatitis C antibody, or HIV 1/2 result at the screening visit. * Abuse of alcohol defined as an average weekly intake of greater than 28 units or an average daily intake of greater than 4 units. * The subject has clinically significant elevations in liver function tests (LFT) that are elevated above the reference range at pre-study screening and remain elevated with a repeat LFT, and/or prior to receiving the first dose of study medication. * Consumption of grapefruit juice or grapefruit within 7 days prior to receiving the first dose of study medication. * Any subject who is not prepared to eat the standard meals provided by the Clinical Pharmacology Research Unit (CPRU) during the study. * Participation in a clinical trial with a new chemical entity within 4 months before the first dose of study medication or marketed compound within 3 months before receiving the first dose of study medication. * Use of prescription or non-prescription drugs, including, over the counter remedies, vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to receiving the first dose of study medication, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety. * Loss of more than 600mL blood during the 120 days before study start. * History or presence of allergy to the study drug or drugs of this class, or a history of other allergy that, in the opinion of the physician responsible, contraindicates his participation in the study. * History of regular use of tobacco- or nicotine-containing products within 6 months of the start of the study (i.e., from Screening Visit 1). * An unwillingness of the male subject to use condoms or practise abstinence to prevent exposure of a female partner to semen from the start of the study (i.e., from Screening Visit 1) until 90 days after the study treatment has ended. * History of psychiatric disorder either Axis I or II by DSM-IV. * History or presence of respiratory illnesses, gastrointestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs. * The subject has a screening ECG with values outside of ranges defined in the protocol. * The subject has a screening heart rate \<50 or \>100 bpm and a systolic blood pressure \>140 and \<100 mmHg and a diastolic blood pressure \>90 and \<60 mmHg in the semi-supine position. * The subject has a reduction in systolic blood pressure of 20 mmHg or more, or a reduction in diastolic blood pressure of 10 mmHg or more on standing compared to the supine measurement at screening. * History of long QT syndrome (personal or family) or other cardiac conduction disorder, or other clinically significant cardiac disease. * The subject is unable to abstain from strenuous physical activity for 24 h prior to the screening visit and for 24 h prior to admission for each treatment period. * Inability of the subject to be successfully trained in tests of cognition prior to receiving the first dose of study medication. **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Harrow **Country:** United Kingdom **Facility:** GSK Investigational Site **State:** Middlesex **Zip:** HA13UJ #### Overall Officials **Official 1:** **Affiliation:** GlaxoSmithKline **Name:** GSK Clinical Trials **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000064419 - Term: Chemically-Induced Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC25 - Name: Substance Related Disorders - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M21837 - Name: Substance-Related Disorders - Relevance: HIGH - As Found: Substance Dependence - ID: M30302 - Name: Chemically-Induced Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000019966 - Term: Substance-Related Disorders ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02653079 **Acronym:** IMMO-LDRT01 **Brief Title:** Immunophenotyping From Blood of Patients Suffering From Chronic Degenerating Joint Diseases and Receiving LDRT **Official Title:** Immunophenotyping From Blood of Patients Suffering From Chronic Degenerating Joint Diseases and Receiving Local Low Dose Radiation Therapy (LDRT) #### Organization Study ID Info **ID:** IMMO-LDRT01 #### Organization **Class:** OTHER **Full Name:** University of Erlangen-Nürnberg Medical School ### Status Module #### Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-02-16 **Type:** ACTUAL **Last Update Submit Date:** 2023-02-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2016-06 **Status Verified Date:** 2023-02 #### Study First Post Date **Date:** 2016-01-12 **Type:** ESTIMATED **Study First Submit Date:** 2016-01-08 **Study First Submit QC Date:** 2016-01-08 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Erlangen-Nürnberg Medical School #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Patients suffering from chronic degenerating diseases are often treated by a plethora of NSAIDs, DMARDs, Biologicals, as well as combinations of these therapeutics. However, many patients are refractory to this treatment and suffer from chronic pain over years, leading to a worsening of the quality of live. The mobilization of these patients is one main goal in the therapy of these chronic and inflammatory diseases. Low dose radiation therapy (LDRT) is applied since more than one century for the local treatment of chronic degenerating joint diseases. The success of the treatment was described by many retrospective as well as pattern of care studies, respectively. Local (only at the painful joint) low dose irradiation of the chronic patients results in most patients in a significantly reduced pain, not only direct after the therapy, but also lasting for more than 12 month in many cases. The patients experience enhanced mobility and increased quality of life. The molecular and cellular processes leading to the pain reduction are just fragmentarily analyzed. Our group revealed that macrophages are key players in radiation-induced immune modulation. Inflammatory macrophages exposed to low doses of radiation showed a reduced inflammatory capacity and attenuated an inflammatory microenvironment. Besides macrophages further immune cells are most likely involved in reduction of inflammation following LD-RT, as in vitro already shown for neutrophils. The IMMO-LDRT01 study aims for the first time to analyze in detail the immune status of patients suffering from inflammatory, chronic joint diseases before, during and after LD-RT in a longitudinal manner. The multi-color flow cytometry-based assay will allow determining over 30 immune cell subsets and additionally their activation status. Further, biodosimetry will be performed with the whole-blood samples to get hints about dose that the immune cells are exposed to. This will be performed with national and international co-operation partners. The IMMO-LDRT01 study is a prospective and observational study not influencing the standard therapeutic scheme and will provide hints how the LDRT affects besides local cells in the irradiated area also the systemic inflammatory response. ### Conditions Module **Conditions:** - Chronic Inflammatory Disorder ### Design Module #### Bio Spec **Description:** Serum, Plasma, Blood cells **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 250 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Blood draw and Questionaire from patients suffering from chronic inflammatory diseases of the joints, namely painful shoulder syndrome (periarthritis humeroscapularis), painful elbow syndrome (Epicondylopathia humeri), benign achillodynia, and benign calcaneodynia, Arthrosis (finger- and Rhizarthrosis, Gonarthrosis, Anklearthrosis), and Arthritis with an planned local low dose radiation therapy (LDRT) at the Department of Radiation Oncology, Universitätsklinikum Erlangen. **Intervention Names:** - Other: Blood Draw and Questionaire **Label:** Study Cohort ### Interventions #### Intervention 1 **Arm Group Labels:** - Study Cohort **Description:** The study is observational. The treatment-plan of the underlying disease remained unchanged. Blood draw from patients at several time points during and after low dose radiation therapy. **Name:** Blood Draw and Questionaire **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Immunophenotyping of the patients: Detection of about 30 distinct immune sell (sub)types together with their activation markers. The analyses are conducted at time points before (day 0) and after low dose radiation therapy (day 21): before LDRT (day 0), end of first round of LDRT (last day of LDRT, usually at 3 Gy), and 3 month (day 111) after completed RT. This scheme is repeated if patient receives additional round of LDRT for relapse treatment. **Measure:** Change of circulating immune cells of treated patients by deep immunophenotyping. **Time Frame:** up to 3 month after completion of RT #### Secondary Outcomes **Description:** Analysis of the pain by VAS (visaul Analog Scale; 0 - lowest pain intensity, 10 highest pain intensity) at time points before and after low dose radiation therapy: before LDRT (day 0), end of first round of LDRT (last day of LDRT, usually at 3 Gy), and 3 month (day 111) after completed RT. This scheme is repeated if patient receives additional round of LDRT for relapse treatment. **Measure:** Change of joint pain intensity of the treated patients. **Time Frame:** up to 9 month after completion of RT **Description:** Analysis of the functional capacity in daily life by FFbH-R (Funktionsfragebogen Hannover, 100% normal to 10 % nearly complete restricted) questionnaire at time points before and after low dose radiation therapy: before LDRT (day 0), end of first round of LDRT (last day of LDRT, usually at 3 Gy), and 3 month (day 111) after completed RT. This scheme is repeated if patient receives additional round of LDRT for relapse treatment. **Measure:** Change of functional capacity in daily life of the treated patients **Time Frame:** up to 9 month after completion of RT **Description:** Analysis of the health-related quality of life by EQ5DL (health index value) questionnaire at time points before and after low dose radiation therapy: before LDRT (day 0), end of first round of LDRT (last day of LDRT, usually at 3 Gy), and 3 month (day 111) after completed RT. This scheme is repeated if patient receives additional round of LDRT for relapse treatment. **Measure:** Change of health-related quality of life **Time Frame:** up to 9 month after completion of RT **Description:** Analysis of the pain by descriptive questionnaire at time points before and after low dose radiation therapy: before LDRT (day 0), end of first round of LDRT (last day of LDRT, usually at 3 Gy), and 3 month (day 111) after completed RT. This scheme is repeated if patient receives additional round of LDRT for relapse treatment. **Measure:** description of pain quality **Time Frame:** up to 9 month after completion of RT ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients suffering and diagnosed for: * painful shoulder syndrome (periarthritis humeroscapularis) * painful elbow syndrome (Epicondylopathia humeri) * benign achillodynia * benign calcaneodynia * arthosis (finger- , rhiz-, gon-, and anklearthrosis * arthritis (gon- and anklearthrosis) * Planned local low dose radiation therapy (LDRT) at the Department of Radiation Oncology, Universitätsklinikum Erlangen. * Age at least 18 years Exclusion Criteria: * patients who are suffering or had suffered from any malignant diseases * fertile patients who refuse effective contraception during study treatment * persistent drug and/or alcohol abuse * patients not able or willing to behave according to study protocol * patients in care * patients that are not able to speak German **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients suffering from chronic inflammatory diseases of the joints, namely painful shoulder syndrome (periarthritis humeroscapularis), painful elbow syndrome (Epicondylopathia humeri), benign achillodynia, benign calcaneodynia, arthosis (finger- , rhiz-, gon-, and anklearthrosis, and arthritis (gon- and anklearthrosis). Patients were attributed to our clinic and the study protocol was explained in detail. The patients have to give their informed consent before starting with the LDRT. The treatment-plan of the underlying disease remained unchanged. This treatment scheme is conducted with 2 irradiations within 7 days for total treatment duration of 3 weeks. The single dose is 0.5 Gy and the complete dose of one round of LDRT is 3 Gy. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Benjamin Frey, PhD **Phone:** +49 9131 85 44248 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Marga Lang-Welzenbach, M.A. **Phone:** +49 9131 85 33968 **Role:** CONTACT #### Locations **Location 1:** **City:** Erlangen **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Benjamin Frey, PhD - **Phone:** +49 91 31 85 44248 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Marga Lang-Welzenbach, M.A. - **Phone:** +49 91 31 85 33968 - **Role:** CONTACT **Country:** Germany **Facility:** Department of Radiation Oncology, Universitätsklinikum Erlangen **State:** Bavaria **Status:** RECRUITING **Zip:** 91054 #### Overall Officials **Official 1:** **Affiliation:** Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg **Name:** Oliver J Ott, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg **Name:** Udo S Gaipl, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Donaubauer AJ, Becker I, Weissmann T, Frohlich BM, Munoz LE, Gryc T, Denzler M, Ott OJ, Fietkau R, Gaipl US, Frey B. Low Dose Radiation Therapy Induces Long-Lasting Reduction of Pain and Immune Modulations in the Peripheral Blood - Interim Analysis of the IMMO-LDRT01 Trial. Front Immunol. 2021 Oct 12;12:740742. doi: 10.3389/fimmu.2021.740742. eCollection 2021. Erratum In: Front Immunol. 2022 Feb 07;13:859489. **PMID:** 34712229 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009140 - Term: Musculoskeletal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10621 - Name: Joint Diseases - Relevance: HIGH - As Found: Joint Disease - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007592 - Term: Joint Diseases ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05463679 **Acronym:** PREVEnt **Brief Title:** Investigate Efficacy, Safety, and Pharmacokinetics of Enzastaurin for the Prevention of Arterial Events in Patients With Vascular Ehlers-Danlos Syndrome. **Official Title:** A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Enzastaurin for the Prevention of Arterial Events in Patients With Vascular Ehlers-Danlos Syndrome (vEDS) Confirmed With COL3A1 Mutations, Followed by an Open Label Extension (OLE) #### Organization Study ID Info **ID:** AR101-PREVEnt #### Organization **Class:** INDUSTRY **Full Name:** Aytu BioPharma, Inc. ### Status Module #### Completion Date **Date:** 2027-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-03-08 **Type:** ACTUAL **Last Update Submit Date:** 2024-03-06 **Overall Status:** SUSPENDED #### Primary Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Start Date **Date:** 2025-01 **Type:** ESTIMATED **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2022-07-19 **Type:** ACTUAL **Study First Submit Date:** 2022-04-06 **Study First Submit QC Date:** 2022-07-14 **Why Stopped:** Indefinite hold by company ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Parexel #### Lead Sponsor **Class:** INDUSTRY **Name:** Aytu BioPharma, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to investigate the efficacy of enzastaurin compared to placebo in preventing arterial events (rupture, dissection, pseudoaneurysm, carotid-cavernous sinus fistula, or aneurysm, fatal or not) leading to intervention or mortality attributable to an arterial event in patients with vEDS confirmed with pathogenic heterozygous COL3A1 gene mutations predicted to derive a mutant protein. **Detailed Description:** The primary efficacy endpoint of this study will be defined as the time to intervention for an arterial event (rupture, dissection, pseudoaneurysm, carotid-cavernous sinus fistula, or aneurysm, fatal or not) or mortality attributable to an arterial event, as adjudicated by an Event Committee, and will be analyzed for difference of active vs. placebo treatments on top of background standard of care, using survival statistical analysis. Furthermore, secondary endpoints will include the rate of intestinal rupture, pneumothorax, and retinal detachment, as adjudicated by an Event Committee, safety and tolerability, as well as hospitalizations and Health Related Quality of Life (HQRL) measures. ### Conditions Module **Conditions:** - Vascular Ehlers-Danlos Syndrome ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Two-arm, multicenter, randomized, double-blind, placebo-controlled study in patients with vEDS receiving enzastaurin 500 mg once daily (QD) compared to placebo, in addition to background standard of care, followed by an OLE phase. Approximately 260 patients with vEDS are planned to be randomized in a 1:1 ratio of enzastaurin or placebo. Patients will be enrolled in the study if they meet all eligibility criteria. ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 260 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Receive 500 mg enzastaurin QD plus background standard of care. **Intervention Names:** - Drug: Enzastaurin **Label:** Enzastaurin 500 mg QD **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Matching placebo QD plus background standard of care. **Intervention Names:** - Drug: Placebo **Label:** Placebo QD **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Enzastaurin 500 mg QD **Description:** 500 mg QD orally in the form of four 125 mg tablets with background standard of care **Name:** Enzastaurin **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo QD **Description:** Placebo to match enzastaurin 500 mg QD orally in the form of four 125 mg tablets with background standard of care **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Time to intervention for an arterial event (rupture, dissection, pseudoaneurysm, carotid-cavernous sinus fistula, or aneurysm, fatal or not) or mortality attributable to an arterial event, as adjudicated by an Event Committee and analyzed for difference in the time-to-composite-event of active vs. placebo treatments, using survival analysis until end of study **Measure:** Time to intervention for an arterial event (rupture, dissection, pseudoaneurysm, carotid-cavernous sinus fistula, or aneurysm, fatal or not) or mortality attributable to an arterial event. **Time Frame:** 30 months #### Secondary Outcomes **Description:** An Adverse Event (AE) is defined as any untoward medical occurrence associated with the use of the investigational product in humans, whether or not considered related to investigational product. An AE can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with any use of the investigational product, without any judgment about causality and irrespective of route of administration, formulation, or dose, including an overdose. **Measure:** Number of and proportion of patients with adverse events, or with abnormal vital signs, physical examinations, ophthalmological examinations, clinical laboratory values, or electrocardiograms (ECGs) medical attention. **Time Frame:** 30 months **Description:** Discontinuation or withdrawal from the study **Measure:** Number of and proportion of patients who discontinue study drug due to adverse events **Time Frame:** 30 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Subjects aged 18 - 60 years old at time of initial screening. 2. Adolescent subjects aged 12 - 17 years old, may be considered to enroll later in the clinical trial pending interim analysis. 3. Diagnosis for VEDS (vascular Ehlers Danlos Syndrome), with a confirmed and documented COL3A1 genetic variant. 4. Subject should be stable, having no VEDS-related vascular events within the past 3 months prior to enrollment. 5. Confirmed use of contraception for both male and female participants. Exclusion Criteria: 1. Inability to swallow or receive intact tablets. 2. Currently being treated with CYP3A4 inhibitors within 4 weeks prior to enrollment. 3. Known allergy or hypersensitivity to enzastaurin. 4. Patient currently pregnant or breast feeding. Other criteria will be reviewed at the first study visit to determine if you are able to participate in the study. **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Englewood **Country:** United States **Facility:** Aytu BioPharma **State:** Colorado **Zip:** 80112 #### Overall Officials **Official 1:** **Affiliation:** University of Washington **Name:** Sherene Shalhub, M.D., M.P.H. **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Texas Children's Hospital and Baylor College of Medicine **Name:** Shaine Morris, M.D.,M.P.H. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Bowen CJ, Calderon Giadrosic JF, Burger Z, Rykiel G, Davis EC, Helmers MR, Benke K, Gallo MacFarlane E, Dietz HC. Targetable cellular signaling events mediate vascular pathology in vascular Ehlers-Danlos syndrome. J Clin Invest. 2020 Feb 3;130(2):686-698. doi: 10.1172/JCI130730. **PMID:** 31639107 #### See Also Links **Label:** 2. Bowen CJ et al. Targetable cellular signaling events mediate vascular pathology in vascular Ehlers-Danlos Syndrome. J Clin Invest. 2020 Feb 3;130(2):686-698. **URL:** https://www.clinicaltrials.gov/ct2/show/NCT00332202 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000020141 - Term: Hemostatic Disorders - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000006474 - Term: Hemorrhagic Disorders - ID: D000006402 - Term: Hematologic Diseases - ID: D000012868 - Term: Skin Abnormalities - ID: D000000013 - Term: Congenital Abnormalities - ID: D000012873 - Term: Skin Diseases, Genetic - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000003095 - Term: Collagen Diseases - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000012871 - Term: Skin Diseases - ID: D000000784 - Term: Aortic Dissection - ID: D000094665 - Term: Dissection, Blood Vessel - ID: D000000783 - Term: Aneurysm ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M7704 - Name: Ehlers-Danlos Syndrome - Relevance: HIGH - As Found: Ehlers-Danlos Syndrome - ID: M3069 - Name: Ehlers-Danlos Syndrome, Type IV - Relevance: HIGH - As Found: Vascular Ehlers-Danlos Syndrome - ID: M21977 - Name: Hemostatic Disorders - Relevance: LOW - As Found: Unknown - ID: M5059 - Name: Blood Coagulation Disorders - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M9560 - Name: Hemorrhagic Disorders - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M15672 - Name: Skin Abnormalities - Relevance: LOW - As Found: Unknown - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M15676 - Name: Skin Diseases, Genetic - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M4114 - Name: Aortic Dissection - Relevance: LOW - As Found: Unknown - ID: M3081 - Name: Dissection, Blood Vessel - Relevance: LOW - As Found: Unknown - ID: M4113 - Name: Aneurysm - Relevance: LOW - As Found: Unknown - ID: T2043 - Name: Ehlers-Danlos Syndromes - Relevance: HIGH - As Found: Ehlers-Danlos Syndrome - ID: T5841 - Name: Vascular Ehlers-Danlos Syndrome - Relevance: HIGH - As Found: Vascular Ehlers-Danlos Syndrome ### Condition Browse Module - Meshes - ID: D000004535 - Term: Ehlers-Danlos Syndrome - ID: D000094623 - Term: Ehlers-Danlos Syndrome, Type IV - ID: D000013577 - Term: Syndrome ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03137979 **Brief Title:** Gingiva Mesenchymal Stem Cells Treatment of Chronic Periodontitis **Official Title:** The Safety and Efficacy Evaluation of Gingiva Mesenchymal Stem Cells Transplantation in Chronic Periodontitis Patients #### Organization Study ID Info **ID:** 17277787D-PD #### Organization **Class:** OTHER **Full Name:** Hebei Medical University ### Status Module #### Completion Date **Date:** 2019-12 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2017-05-03 **Type:** ACTUAL **Last Update Submit Date:** 2017-04-28 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2018-12 **Type:** ESTIMATED #### Start Date **Date:** 2017-01 **Status Verified Date:** 2017-04 #### Study First Post Date **Date:** 2017-05-03 **Type:** ACTUAL **Study First Submit Date:** 2017-04-24 **Study First Submit QC Date:** 2017-04-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hebei Medical University #### Responsible Party **Investigator Affiliation:** Hebei Medical University **Investigator Full Name:** Quanhai Li **Investigator Title:** Director of Cell Thearpy Center, the First Hospital of HebeiMU **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study is to evaluate the safety and efficacy of Gingiva Mesenchymal Stem Cell Therapy for Chronic Adult Periodontitis. **Detailed Description:** Periodontitis featured by the progressive destruction loss of support tissues around the teeth has become a prevalent disease affecting the life quality of the adults. Although conventional periodontal treatment including open flap debridement and drug support therapy display reduced pocket depth and inflammation, the functional regeneration of the lost tissue and the repair of alveolar bone are insufficient. Gingiva mesenchymal stem cells (GMSCs) are multipotent cells possess the capacity of multilineage differentiation and have become an attractive optional treatment method for the regeneration of periodontal tissues and function. Therefore, GMSCs will be selected as seed cells to treat periodontitis. This study will recruit 30 patients which will be divided into three groups. 10 patients in group A will receive GMSCs seeded into collagen scaffolds at the local periodontal defects immediately after open flap debridement. 10 patients in group B will only receive collagen scaffolds devoid of GMSCs after open flap debridement. 10 patients in group C will only undergo an open flap debridement. This study will test the safety and efficacy of GMSCs implantation in chronic adult periodontitis through alveolous bone reproduction and other clinical parameters. ### Conditions Module **Conditions:** - Periodontitis **Keywords:** - Periodontitis - Gingiva mesenchymal stem cells ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients in group A will receive GMSCs seeded into collagen scaffolds at the local periodontal defects immediately after open flap debridement. **Intervention Names:** - Biological: GMSCs and collagen scaffolds **Label:** Group A: GMSCs and collagen scaffolds **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients in group B will receive collagen scaffolds implantation at the local periodontal defects immediately after open flap debridement. **Intervention Names:** - Biological: Collagen scaffolds **Label:** Group B: collagen scaffolds **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Patients in comparator group will only undergo an open flap debridement. **Intervention Names:** - Procedure: Open flap debridement **Label:** Group C: comparator **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Group A: GMSCs and collagen scaffolds **Description:** Patients in this group were given GMSCs and collagen scaffolds. **Name:** GMSCs and collagen scaffolds **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Group B: collagen scaffolds **Description:** Patients in this group were given collagen scaffolds. **Name:** Collagen scaffolds **Type:** BIOLOGICAL #### Intervention 3 **Arm Group Labels:** - Group C: comparator **Description:** The patients in this group will only receive the treatment of open flap debridement. **Name:** Open flap debridement **Type:** PROCEDURE ### Outcomes Module #### Other Outcomes **Description:** Adverse reaction include temperature changes, allergy, nausea and so on 6 months after intervention. **Measure:** Adverse reaction **Time Frame:** Post cell transplantation: 1, 3, 6 months #### Primary Outcomes **Description:** A increase in the height of alveolar bone in mm examined by computed tomography (CT) **Measure:** The evaluation of alveolar bone regeneration **Time Frame:** Baseline and Post cell transplantation: 1,3, 6months after intervention #### Secondary Outcomes **Description:** A reduced distance in mm between the gingival margin and the bottom was measured by a manual periodontal probe. **Measure:** Probing pocket depth (PPD) **Time Frame:** Baseline and Post cell transplantation: 3, 6 months after intervention. **Description:** A reduced distance in mm from the bottom of the periodontal pocket to the dentinocemental junction was examined by a manual probe. **Measure:** Attachment level (AL) **Time Frame:** Baseline and Post cell transplantation: 3, 6 months after intervention. **Description:** A decreased degree of GI measured by a manual periodontal probe which was divided into 4 grades: 0, 1, 2 and 3. **Measure:** Gingival index (GI) **Time Frame:** Baseline and Post cell transplantation: 3, 6 months after intervention. **Description:** A decrease of periotest value was measured by periotest to evaluate the tooth mobility changes. **Measure:** Tooth mobility degree (TMD) **Time Frame:** Baseline and Post cell transplantation: 1,3, 6months after intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients with adult periodontitis . 2. The age is from 35 to 60 years old. 3. The bleeding and coagulation function is normal. 4. The liver function is normal. 5. Patients who are suitable for routine treatment of periodontal curettage and other early treatments. 6. Pathological lesion is stable after the routine treatments. 7. Patients with the probing depth ≥6 mm and attachment loss level≥ 3 mm. 8. X ray plates show no significant root furcation lesion appears in the diseased teeth and the infrabony pocket is not less than 4mm deep. 9. Patients with good oral hygiene and/or in whom the plaque control is maintained excellently under the instruction of oral hygiene. 10. Patients who show good compliance. 11. Patients with tooth mobility of degreeⅡor less and the width of attached gingiva is considered appropriate for the existing Guided Tissue Regeneration (GTR) . 12. Patients who have understand the purposes of this clinical trial and can make an independent decision to comply with trial requirements. Exclusion Criteria: 1. Patients with disease of the kidney, liver, blood and/or circulatory system. 2. Patients with diabetes (the fasting plasma glucose level≥7.0mmol/l). 3. Patients who are receiving treatment of hypertension and/or epilepsy. 4. Patients with malignant tumour or the history of this. 5. Patients with the genetic background of the periodontitis. 6. Patients with bone metabolic diseases. 7. Patients in need of administration of adrenal cortical steroid within 4 weeks. 8. Patients with alcoholics. 9. Patients who smoke more than 10 pieces of cigarettes. 10. Patients who suffer from drug induced gingival hyperplasia. 11. Patients with acute symptom of periodontitis. 12. The bone destruction is larger than 2/3 of the root length or the mobility tooth is investigated of more than degree Ⅱ. 13. Patients who are either pregnant, possibly pregnant or breast-feeding, or who hope to become pregnant during the period of the trial. 14. Patients who are participating in in other research team of clinical trial. 15. Patients with mental or consciousness disorder. 16. Patients with a previous history of hypersensitivity to any biological active drugs. 17. Patients who have undergo periodontal treatment within six months. **Maximum Age:** 60 Years **Minimum Age:** 35 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Quanhai Li, Doctor **Phone:** 86-311-85917287 **Role:** CONTACT #### Locations **Location 1:** **City:** Shijiazhuang **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Xianyun Wang, Doctor - **Phone:** 86-311-85917384 - **Role:** CONTACT **Country:** China **Facility:** the First Hospital of Hebei Medical University **State:** Hebei **Status:** RECRUITING **Zip:** 050030 #### Overall Officials **Official 1:** **Affiliation:** Hebei Medical University **Name:** Baoyong Yan, Doctor **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** The First Hospital of Hebei Medical University **Name:** Guangshun Liu, Master **Role:** STUDY_DIRECTOR **Official 3:** **Affiliation:** The First Hospital of Hebei Medical University **Name:** Quanhai Li, Doctor **Role:** STUDY_DIRECTOR **Official 4:** **Affiliation:** The First Hospital of Hebei Medical University **Name:** Xianyun Wang, Doctor **Role:** PRINCIPAL_INVESTIGATOR **Official 5:** **Affiliation:** The First Hospital of Hebei Medical University **Name:** Jinhong Zhang, Master **Role:** PRINCIPAL_INVESTIGATOR **Official 6:** **Affiliation:** the First Hospital of Hebei Medical UniversityT **Name:** Yao Wang, Bachelor **Role:** PRINCIPAL_INVESTIGATOR **Official 7:** **Affiliation:** The First Hospital of Hebei Medical University **Name:** Jun Zhang, Master **Role:** PRINCIPAL_INVESTIGATOR **Official 8:** **Affiliation:** The First Hospital of Hebei Medical University **Name:** Xiangwei Ren, Master **Role:** PRINCIPAL_INVESTIGATOR **Official 9:** **Affiliation:** The First Hospital of Hebei Medical University **Name:** Qianfeng Liu, Bachelor **Role:** PRINCIPAL_INVESTIGATOR **Official 10:** **Affiliation:** The First Hospital of Hebei Medical University **Name:** Yongbin Di, Master **Role:** PRINCIPAL_INVESTIGATOR **Official 11:** **Affiliation:** The First Hospital of Hebei Medical University **Name:** Boyu Liu, Bachelor **Role:** PRINCIPAL_INVESTIGATOR **Official 12:** **Affiliation:** The First Hospital of Hebei Medical University **Name:** Fan Zhang, Bachelor **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010510 - Term: Periodontal Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13427 - Name: Periodontitis - Relevance: HIGH - As Found: Periodontitis - ID: M28044 - Name: Chronic Periodontitis - Relevance: HIGH - As Found: Chronic Periodontitis - ID: M13419 - Name: Periodontal Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010518 - Term: Periodontitis - ID: D000055113 - Term: Chronic Periodontitis ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00916279 **Acronym:** PERVIDEO I **Brief Title:** PERVIDEO I Registry, The Lutonix Paclitaxel-Coated Balloon Catheter for the Treatment of Coronary In-Stent Restenosis **Official Title:** A Prospective, Multicenter, European Registry Investigating the Lutonix Paclitaxel-Coated Balloon for the Treatment of In-Stent Restenosis Within Bare-Metal Stents #### Organization Study ID Info **ID:** CL0010-01 #### Organization **Class:** INDUSTRY **Full Name:** C. R. Bard ### Status Module #### Completion Date **Date:** 2011-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-02-27 **Type:** ACTUAL **Last Update Submit Date:** 2017-01-12 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2010-10 **Type:** ACTUAL #### Results First Post Date **Date:** 2015-12-21 **Type:** ESTIMATED **Results First Submit Date:** 2014-08-05 **Results First Submit QC Date:** 2015-11-17 #### Start Date **Date:** 2009-06 **Status Verified Date:** 2017-01 #### Study First Post Date **Date:** 2009-06-09 **Type:** ESTIMATED **Study First Submit Date:** 2009-06-04 **Study First Submit QC Date:** 2009-06-05 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** C. R. Bard #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The study will enroll patients with angiographic evidence of in-stent restenosis of a previously placed bare-metal stent. Subjects will be treated with a Lutonix Catheter. The purpose is to investigate the feasibility, safety, and efficacy of the Lutonix Catheter in the native coronary system. Angiographic and clinical outcomes will be assessed. ### Conditions Module **Conditions:** - In-Stent Restenosis **Keywords:** - Bare Metal In-Stent Restenosis - Paclitaxel Coated Balloon Catheter - Drug Coated Balloon - Coronary Artery Disease ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 41 **Type:** ACTUAL **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Device: Lutonix Paclitaxel-Coated Balloon **Label:** Lutonix Catheter **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Lutonix Catheter **Description:** PTCA **Name:** Lutonix Paclitaxel-Coated Balloon **Other Names:** - Drug Coated Balloon **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Measure:** Percent Diameter Stenosis (%DS) in the Analysis Segment **Time Frame:** 6 months **Description:** Paired change in percent diameter stenosis (%DS) in the analysis segment from post-procedure through 6 months. I.e., %DS at follow-up less %DS post procedure per patient. **Measure:** Change in Diameter Stenosis (%DS) From Post-procedure Through 6 Months **Time Frame:** 6 Months #### Secondary Outcomes **Description:** Change in (loss of) lumen diameter from baseline through 6 months in the analysis segment (including the treated segment and 5mm proximal and distal). **Measure:** Late Lumen Loss **Time Frame:** 6 months **Description:** Major adverse coronary events (MACE), including the composite of cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR). **Measure:** MACE Rate **Time Frame:** 30 Days **Description:** Subjects with percent diameter stenosis \>50% in the analysis segment. **Measure:** Binary Restenosis **Time Frame:** 6 Months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or non-pregnant/non-breast feeding Female ≥18 Years of age. Women of childbearing potential must have a negative pregnancy test within 7 days of the procedure; * Documented stable angina pectoris Canadian Cardiovascular Society Classification (CCSC) 1-4, unstable angina pectoris with documented ischemia (Braunwald I-II) or documented silent ischemia; * Previous history of native coronary bare metal stenting ≥60 days; * LVEF ≥25%; * Patient is an acceptable candidate for PTCA, stenting, and emergent CABG; * Patient is willing to provide informed consent and comply with follow-up visits and testing schedule; * Target lesion is in a native coronary with previous single bare metal stent; Stenosis is ≥50% and \<100% by visual estimate or QCA prior to defined pre-dilatation; * Reference Vessel Diameter (RVD) is ≥2.5 and ≤3.25; * Target lesion is ≤40 mm in length and can be treated in its entirety by no more than 2 contiguous Lutonix Catheters; * Guidewire is able to cross lesion(s) and be placed in distal vessel prior to enrollment; * Enrollment permitted after successful treatment of 1 to 2 non-study lesions in a single other non-study vessel. Successful treatment is defined as ≤30% residual stenosis with TIMI III flow and no evidence of dissection. Exclusion Criteria: * History of Stroke within past 6 months; * History of MI or thrombolysis within 72 hours of randomization; * History of previous target vessel perforation; * Prior vascular brachytherapy; * Angiographic evidence of thrombus or dissection within the target vessel; * Intervention of another coronary lesion \<60 days before index procedure day or planned following index procedure; * Target lesion is in the Left Main or vessel ostium and has excessive calcification or tortuosity or involves bifurcation disease of vessel ≥2.5 mm; * Target lesion is planned to be treated with something other than PTCA (i.e. stent, cutting balloon, atherectomy, VBT, etc.); * Uncontrollable allergies to procedure medications, materials, or contrast; * Patient has previous stent procedure with any drug-coated or drug eluting stent device in the target coronary vessel; * Known sensitivity to paclitaxel or other antimitogenic agent; * Patient has a stent sandwich (a stench previously deployed within another stent; * Pre-procedure CKMB \>2x ULN or positive Troponin; * Creatinine \>2.0 mg/dl; * Leukocyte \<3500/mL; * Platelet \<100,000 mL or \>750,000 mL; * Currently taking or must resume warfarin; * Patient is contraindicated for anti-platelet therapy or it will need to be withdrawn for a planned procedure; * The patient is currently participating in another investigational drug or device study that has not completed its primary endpoint or that clinically interferes with the endpoints of this study; **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Aalst **Country:** Belgium **Facility:** Onze Lieve Vrouw Ziekenhuis **Zip:** 9300 **Location 2:** **City:** Bad Nauheim **Country:** Germany **Facility:** Kerckhoff Klinik **Zip:** 61231 **Location 3:** **City:** Essen **Country:** Germany **Facility:** Westdeutsches Herzzentrum Essen **Location 4:** **City:** Hamburg **Country:** Germany **Facility:** Alte Clinic Center for Cardiology **Zip:** 22527 **Location 5:** **City:** Leipzig **Country:** Germany **Facility:** Herzzentrum Leipzig GmbH **Location 6:** **City:** Amsterdam **Country:** Netherlands **Facility:** Academic Medical Center **Location 7:** **City:** Eindhoven **Country:** Netherlands **Facility:** Catherina Ziekenhuis **Location 8:** **City:** Nieuwegein **Country:** Netherlands **Facility:** Sint Antonius Ziehenhuis #### Overall Officials **Official 1:** **Affiliation:** Brigham & Women's Hospital, Boston, MA **Name:** Laura Mauri, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Scheller B, Speck U, Abramjuk C, Bernhardt U, Bohm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004 Aug 17;110(7):810-4. doi: 10.1161/01.CIR.0000138929.71660.E0. Epub 2004 Aug 9. **PMID:** 15302790 **Citation:** Speck U, Scheller B, Abramjuk C, Breitwieser C, Dobberstein J, Boehm M, Hamm B. Neointima inhibition: comparison of effectiveness of non-stent-based local drug delivery and a drug-eluting stent in porcine coronary arteries. Radiology. 2006 Aug;240(2):411-8. doi: 10.1148/radiol.2402051248. **PMID:** 16864669 **Citation:** Stone GW, Ellis SG, O'Shaughnessy CD, Martin SL, Satler L, McGarry T, Turco MA, Kereiakes DJ, Kelley L, Popma JJ, Russell ME; TAXUS V ISR Investigators. Paclitaxel-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the TAXUS V ISR randomized trial. JAMA. 2006 Mar 15;295(11):1253-63. doi: 10.1001/jama.295.11.1253. Epub 2006 Mar 12. **PMID:** 16531618 **Citation:** Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13. **PMID:** 17101615 **Citation:** Holmes DR Jr, Teirstein P, Satler L, Sketch M, O'Malley J, Popma JJ, Kuntz RE, Fitzgerald PJ, Wang H, Caramanica E, Cohen SA; SISR Investigators. Sirolimus-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the SISR randomized trial. JAMA. 2006 Mar 15;295(11):1264-73. doi: 10.1001/jama.295.11.1264. Epub 2006 Mar 12. **PMID:** 16531619 **Citation:** Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994 Aug 25;331(8):489-95. doi: 10.1056/NEJM199408253310801. **PMID:** 8041413 **Citation:** Kastrati A, Mehilli J, von Beckerath N, Dibra A, Hausleiter J, Pache J, Schuhlen H, Schmitt C, Dirschinger J, Schomig A; ISAR-DESIRE Study Investigators. Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial. JAMA. 2005 Jan 12;293(2):165-71. doi: 10.1001/jama.293.2.165. **PMID:** 15644543 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6549 - Name: Coronary Disease - Relevance: LOW - As Found: Unknown - ID: M6546 - Name: Coronary Artery Disease - Relevance: LOW - As Found: Unknown - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - ID: D000000972 - Term: Antineoplastic Agents, Phytogenic - ID: D000000970 - Term: Antineoplastic Agents - ID: D000050257 - Term: Tubulin Modulators - ID: D000050256 - Term: Antimitotic Agents - ID: D000050258 - Term: Mitosis Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M19537 - Name: Paclitaxel - Relevance: HIGH - As Found: Surgery - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M26197 - Name: Tubulin Modulators - Relevance: LOW - As Found: Unknown - ID: M26196 - Name: Antimitotic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000017239 - Term: Paclitaxel ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Lutonix Catheter **Description:** Lutonix Paclitaxel-Coated Balloon: PTCA **ID:** EG000 **Other Num Affected:** 15 **Other Num at Risk:** 41 **Serious Number Affected:** 22 **Serious Number At Risk:** 41 **Title:** Lutonix Catheter **Frequency Threshold:** 5 #### Other Events **Term:** Angina **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** **Term:** Chest Pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** **Term:** Dyspnea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** **Term:** Hypertension **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** **Term:** Palpitations **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** **Term:** Thoracic Pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** #### Serious Events **Term:** Death of unknown cause **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Term:** Abdominal aortic aneurysm **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Term:** Acute renal failure post-interventional **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Term:** Rotoblation of non-target vessel/fell into lung edema & ventricular fibrillation. Resulted in death **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Term:** Aneurysm spurium of RCA **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Term:** Aneurysma rupture by distal endoleak right iliacal **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Term:** Angina **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num Affected:** 6 **Num At Risk:** 41 **Num Events:** 8 **Term:** Bacteria MIC = staphylococcus auras **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Term:** Cardiac decomposition with pneumonia and sepsis and respiratory insufficiency due to pulmonary edema **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Term:** CCSIII caused angio. Occlusion of prox. RCA NTVR done **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Term:** Effective reconstruction: RCA - 3 DES stents (atypical chest pain / discomfort, angiographic stenosi **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Term:** Hospitalization **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 41 **Num Events:** 2 **Term:** Hypertensive Crisis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Term:** Instent Restenosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 41 **Num Events:** 2 **Term:** Kidney Stones **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Term:** Nasal bleeding / epistaxis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Term:** Dyspnea and Thorax Pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Term:** Pericardial abscess **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Term:** Perimyocarditis with pericardial effusion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Term:** Pneumonia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 41 **Num Events:** 2 **Term:** Pulmonary edema **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Term:** Progression of coronary artery disease proximal to treated lesion (non-TLR-PCI) **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Term:** Recurrent Depressive disorder, pre-existing condition **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Term:** Reintervention **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Term:** Re-PCI **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 41 **Num Events:** 2 **Term:** Respiratory insufficiency **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Term:** Sepsis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Term:** Stenosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 41 **Num Events:** 5 **Term:** Thoracic pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 2 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 41 **Units:** Participants ### Group **ID:** BG000 **Title:** Lutonix Catheter **Description:** Lutonix Paclitaxel-Coated Balloon: PTCA ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** <=18 years #### Measurement **Group ID:** BG000 **Value:** 14 **Category Title:** Between 18 and 65 years #### Measurement **Group ID:** BG000 **Value:** 27 **Category Title:** >=65 years **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 11.0 **Value:** 64.4 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 10 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 31 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 1 **Class Title:** Belgium #### Measurement **Group ID:** BG000 **Value:** 4 **Class Title:** Netherlands #### Measurement **Group ID:** BG000 **Value:** 36 **Class Title:** Germany ### Measure #### Measurement **Group ID:** BG000 **Value:** 17 **Class Title:** CFX #### Measurement **Group ID:** BG000 **Value:** 13 **Class Title:** LAD #### Measurement **Group ID:** BG000 **Value:** 11 **Class Title:** RCA **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Categorical **Unit of Measure:** Participants ### Measure 2 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** Years ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Gender **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ### Measure 5 **Description:** Target coronary vessel(s) treated: circumflex (CFX), left anterior descending (LAD), right coronary artery (RCA). **Parameter Type:** NUMBER **Title:** Target Lesion Location **Unit of Measure:** participants ## Results Section - More Information Module ### Certain Agreement **Restriction Type:** OTHER **Restrictive Agreement:** True ### Point of Contact **Email:** [email protected] **Organization:** Lutonix Inc. a subsidiary of C.R. Bard **Phone:** 763-445-2352 **Title:** Chris Barry ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ### Outcome Measure 5 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 17.6 - **Upper Limit:** - **Value:** 36.0 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.39 - **Upper Limit:** - **Value:** 0.17 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 16.9 - **Upper Limit:** - **Value:** 8.5 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** ITT **Reporting Status:** POSTED **Time Frame:** 6 months **Title:** Percent Diameter Stenosis (%DS) in the Analysis Segment **Type:** PRIMARY **Unit of Measure:** Percentage stenosis of vessel diameter ##### Group **Description:** Lutonix paclitaxel-coated PTCA balloon catheter **ID:** OG000 **Title:** Lutonix DCB Catheter #### Outcome Measure 2 **Description:** Change in (loss of) lumen diameter from baseline through 6 months in the analysis segment (including the treated segment and 5mm proximal and distal). **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** ITT **Reporting Status:** POSTED **Time Frame:** 6 months **Title:** Late Lumen Loss **Type:** SECONDARY **Unit of Measure:** (mm) ##### Group **Description:** Lutonix Paclitaxel-Coated Balloon: PTCA **ID:** OG000 **Title:** Lutonix Catheter #### Outcome Measure 3 **Description:** Major adverse coronary events (MACE), including the composite of cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR). **Parameter Type:** NUMBER **Population Description:** ITT **Reporting Status:** POSTED **Time Frame:** 30 Days **Title:** MACE Rate **Type:** SECONDARY **Unit of Measure:** Percentage of patients ##### Group **Description:** Lutonix Paclitaxel-Coated Balloon: PTCA **ID:** OG000 **Title:** Lutonix PTCA Catheter #### Outcome Measure 4 **Description:** Paired change in percent diameter stenosis (%DS) in the analysis segment from post-procedure through 6 months. I.e., %DS at follow-up less %DS post procedure per patient. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** ITT **Reporting Status:** POSTED **Time Frame:** 6 Months **Title:** Change in Diameter Stenosis (%DS) From Post-procedure Through 6 Months **Type:** PRIMARY **Unit of Measure:** percent diameter stenosis ##### Group **Description:** Lutonix paclitaxel-coated PTCA balloon catheter **ID:** OG000 **Title:** Lutonix DCB Catheter #### Outcome Measure 5 **Description:** Subjects with percent diameter stenosis \>50% in the analysis segment. **Parameter Type:** NUMBER **Population Description:** ITT **Reporting Status:** POSTED **Time Frame:** 6 Months **Title:** Binary Restenosis **Type:** SECONDARY **Unit of Measure:** participants ##### Group **Description:** Lutonix Paclitaxel-Coated Balloon: PTCA **ID:** OG000 **Title:** Lutonix DCB Catheter ### Participant Flow Module #### Group **Description:** Lutonix Paclitaxel-Coated Balloon: PTCA **ID:** FG000 **Title:** Lutonix DCB Catheter #### Period **Title:** Overall Study ##### Withdraw **Type:** Death ###### Reason **Group ID:** FG000 **Number of Subjects:** 2 ##### Withdraw **Type:** Lost to Follow-up ###### Reason **Group ID:** FG000 **Number of Subjects:** 2 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 41 ##### Milestone **Type:** 30 Days ###### Achievement **Group ID:** FG000 **Number of Subjects:** 41 ##### Milestone **Type:** 6 Months ###### Achievement **Group ID:** FG000 **Number of Subjects:** 41 ##### Milestone **Type:** 24 Months ###### Achievement **Group ID:** FG000 **Number of Subjects:** 37 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 37 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 4 **Recruitment Details:** Enrollment from June 3, 2009 through December 8, 2009 at 7 centers in Germany, Netherlands, and Belgium. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT00519779 **Brief Title:** Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention **Official Title:** Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention #### Organization Study ID Info **ID:** R21AT003912-01A1 **Link:** https://reporter.nih.gov/quickSearch/R21AT003912-01A1 **Type:** NIH #### Organization **Class:** NIH **Full Name:** National Center for Complementary and Integrative Health (NCCIH) #### Secondary ID Infos **ID:** AT003912 ### Status Module #### Completion Date **Date:** 2010-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2012-03-27 **Type:** ESTIMATED **Last Update Submit Date:** 2012-03-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2008-12 **Type:** ACTUAL #### Results First Post Date **Date:** 2012-03-22 **Type:** ESTIMATED **Results First Submit Date:** 2011-11-07 **Results First Submit QC Date:** 2012-02-16 #### Start Date **Date:** 2007-07 **Status Verified Date:** 2012-02 #### Study First Post Date **Date:** 2007-08-23 **Type:** ESTIMATED **Study First Submit Date:** 2007-08-21 **Study First Submit QC Date:** 2007-08-21 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** Office of Dietary Supplements (ODS) #### Lead Sponsor **Class:** NIH **Name:** National Center for Complementary and Integrative Health (NCCIH) #### Responsible Party **Investigator Affiliation:** National Center for Complementary and Integrative Health (NCCIH) **Investigator Full Name:** Janice Kiecolt-Glaser **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is designed to examine the effects of fish oil on immune function and mood in medical students. **Detailed Description:** This study will examine how supplementation with omega-3 polyunsaturated fatty acids (key fish oil components) affects immune and mood responses to examination stress. This study will examine these outcomes in medical students during academic examination periods as well as less stressful non-exam periods. Participants will take fish oil supplements or placebo pills for approximately 3 months during which time relevant mood, endocrine, and immune measures will be assessed. For detailed information about the study, please visit our website at http://www.stressandhealth.org ### Conditions Module **Conditions:** - Stress-related Changes in Inflammation **Keywords:** - affect - inflammation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 68 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Placebo oral Omega-3 fish oil supplementation **Intervention Names:** - Dietary Supplement: Oral omega-3 fish oil placebo **Label:** 2 **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** oral Omega-3 fish oil supplementation **Intervention Names:** - Dietary Supplement: omega-3 supplementation **Label:** 1 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 1 **Description:** 2.5 g/day omega-3 **Name:** omega-3 supplementation **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - 2 **Description:** to match experimental dosage **Name:** Oral omega-3 fish oil placebo **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** log-transformed serum Interleukin-6 (IL-6) Serum cytokine levels provide an assessment of systemic inflammation, the cytokine level circulating throughout the body. Higher levels are typically interrupted as worse unless an individual is acutely ill. Stimulated cytokine production reflects the inflammatory cytokine production capacity of monocytes. **Measure:** Serum ln(IL-6) **Time Frame:** every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points) **Description:** log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha) All cytokine measurements (e.g., IL-6 and TNF-a, serum and stimulated) were analyzed across time; however, no stress effects were found. Therefore, all assessments post-supplementation were averaged (time points 3-6) and analyzed to determine whether fish oil supplementation had an effect. Pooling these 4 assessments provides a better estimate of an individual's cytokine levels because single time point measurements can be affected by changes in exercise, alcohol consumption, or sleep in the preceding 24-48 hours. **Measure:** Serum ln(TNF-a) **Time Frame:** every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points) **Description:** log-transformed stimulated IL-6 Serum cytokine levels provide an assessment of systemic inflammation, the cytokine level circulating throughout the body. Higher levels are typically interrupted as worse unless an individual is acutely ill. Stimulated cytokine production reflects the inflammatory cytokine production capacity of monocytes. **Measure:** Stimulated ln(IL-6) **Time Frame:** every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points) **Description:** log-transformed stimulated TNF-alpha **Measure:** Stimulated ln(TNF-alpha) **Time Frame:** every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points) #### Secondary Outcomes **Description:** log-transformed Beck anxiety score, min-max values - 0-4.1: higher means greater anxiety **Measure:** ln(Beck Anxiety Score) **Time Frame:** every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points) **Description:** log-transformed Center for Epidemiologic Studies Depression Scale (CES-D) score The CES-D is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale. Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms. **Measure:** ln(CES-D) **Time Frame:** every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * OSU preclinical medical or dental student, or graduate nursing student * male or female Exclusion Criteria: * taking certain medications with immune or endocrine effects * chronic health conditions * smoking * excessive use of alcohol or caffeine * significant digestive problems * routine use of fish oil or flaxseed supplements or high fish intake * fish allergy **Healthy Volunteers:** True **Maximum Age:** 40 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Columbus **Country:** United States **Facility:** The Ohio State University College of Medicine **State:** Ohio **Zip:** 43210 #### Overall Officials **Official 1:** **Affiliation:** Ohio State University **Name:** Janice K Kiecolt-Glaser, PhD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Kiecolt-Glaser JK, Belury MA, Andridge R, Malarkey WB, Glaser R. Omega-3 supplementation lowers inflammation and anxiety in medical students: a randomized controlled trial. Brain Behav Immun. 2011 Nov;25(8):1725-34. doi: 10.1016/j.bbi.2011.07.229. Epub 2011 Jul 19. **PMID:** 21784145 #### See Also Links **Label:** Please click here to visit our website if you would like to read more about the study or apply to participate. **URL:** http://www.stressandhealth.org ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10293 - Name: Inflammation - Relevance: HIGH - As Found: Inflammation ### Condition Browse Module - Meshes - ID: D000007249 - Term: Inflammation ### Intervention Browse Module - Browse Branches - Abbrev: Ot - Name: Other Dietary Supplements - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T415 - Name: Omega 3 Fatty Acid - Relevance: HIGH - As Found: Diabetic ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Placebo **Description:** Placebo oral Omega-3 fish oil supplementation **ID:** EG000 **Other Num Affected:** 18 **Other Num at Risk:** 34 **Serious Number At Risk:** 34 **Title:** Placebo **Group ID:** EG001 **Title:** Omega-3 Fish Oil Supplement **Description:** oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid \[EPA\] and 348 mg of docosahexaenoic acid \[DHA\]) **ID:** EG001 **Other Num Affected:** 20 **Other Num at Risk:** 34 **Serious Number At Risk:** 34 **Title:** Omega-3 Fish Oil Supplement **Frequency Threshold:** 5 #### Other Events **Term:** Sore throat **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** **Term:** Nasal symptoms **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** **Term:** Stomach pain **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Tachycardia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** **Term:** Diarrhea **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Skin rash **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** **Term:** Nausea **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Heartburn **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** **Time Frame:** 3 months ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 34 **Group ID:** BG001 **Value:** 34 **Group ID:** BG002 **Value:** 68 **Units:** Participants ### Group **ID:** BG000 **Title:** Placebo **Description:** Placebo oral Omega-3 fish oil supplementation ### Group **ID:** BG001 **Title:** Omega-3 Fish Oil Supplement **Description:** oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid \[EPA\] and 348 mg of docosahexaenoic acid \[DHA\]) ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** <=18 years #### Measurement **Group ID:** BG000 **Value:** 34 #### Measurement **Group ID:** BG001 **Value:** 34 #### Measurement **Group ID:** BG002 **Value:** 68 **Category Title:** Between 18 and 65 years #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** >=65 years **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 1.7 **Value:** 23.4 #### Measurement **Group ID:** BG001 **Spread:** 2.0 **Value:** 23.9 #### Measurement **Group ID:** BG002 **Spread:** 1.9 **Value:** 23.6 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 14 #### Measurement **Group ID:** BG001 **Value:** 16 #### Measurement **Group ID:** BG002 **Value:** 30 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 20 #### Measurement **Group ID:** BG001 **Value:** 18 #### Measurement **Group ID:** BG002 **Value:** 38 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 34 #### Measurement **Group ID:** BG001 **Value:** 34 #### Measurement **Group ID:** BG002 **Value:** 68 **Class Title:** United States **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Categorical **Unit of Measure:** Participants ### Measure 2 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age Continuous **Unit of Measure:** years ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** [email protected] **Organization:** The Ohio State University **Phone:** 614-293-3499 **Title:** Dr. Janice Kiecolt-Glaser ## Results Section - Outcome Measures Module ### Outcome Measure 1 #### Analysis **CI Lower Limit:** -0.18 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.18 **CI Upper Limit Comment:** **Dispersion Type:** STANDARD_ERROR_OF_MEAN **Dispersion Value:** 0.090 **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.97 **P-Value Comment:** **Parameter Type:** Mean Difference (Final Values) **Parameter Value:** -0.0033 **Statistical Comment:** adjusted for baseline value, visit, gender, SAD **Statistical Method:** Mixed Models Analysis **Tested Non-Inferiority:** False ### Outcome Measure 2 #### Analysis **CI Lower Limit:** -0.44 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** -0.011 **CI Upper Limit Comment:** **Dispersion Type:** STANDARD_ERROR_OF_MEAN **Dispersion Value:** 0.11 **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.04 **P-Value Comment:** **Parameter Type:** Mean Difference (Final Values) **Parameter Value:** -0.23 **Statistical Comment:** **Statistical Method:** Mixed Models Analysis **Tested Non-Inferiority:** False ### Outcome Measure 3 #### Analysis **CI Lower Limit:** -0.15 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.002 **CI Upper Limit Comment:** **Dispersion Type:** STANDARD_ERROR_OF_MEAN **Dispersion Value:** 0.039 **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.06 **P-Value Comment:** **Parameter Type:** Mean Difference (Final Values) **Parameter Value:** -0.076 **Statistical Comment:** **Statistical Method:** Mixed Models Analysis **Tested Non-Inferiority:** False ### Outcome Measure 4 #### Analysis **CI Lower Limit:** -0.30 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** -0.009 **CI Upper Limit Comment:** **Dispersion Type:** STANDARD_ERROR_OF_MEAN **Dispersion Value:** 0.072 **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.04 **P-Value Comment:** **Parameter Type:** Mean Difference (Final Values) **Parameter Value:** -0.15 **Statistical Comment:** **Statistical Method:** Mixed Models Analysis **Tested Non-Inferiority:** False ### Outcome Measure 5 #### Analysis **CI Lower Limit:** -0.33 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.018 **CI Upper Limit Comment:** **Dispersion Type:** STANDARD_ERROR_OF_MEAN **Dispersion Value:** 0.086 **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.08 **P-Value Comment:** **Parameter Type:** Mean Difference (Final Values) **Parameter Value:** -0.15 **Statistical Comment:** **Statistical Method:** Mixed Models Analysis **Tested Non-Inferiority:** False ### Outcome Measure 6 #### Analysis **CI Lower Limit:** -0.26 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.29 **CI Upper Limit Comment:** **Dispersion Type:** STANDARD_ERROR_OF_MEAN **Dispersion Value:** 0.14 **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER **Other Analysis Description:** **P-Value:** 0.93 **P-Value Comment:** **Parameter Type:** Mean Difference (Final Values) **Parameter Value:** 0.012 **Statistical Comment:** **Statistical Method:** Mixed Models Analysis **Tested Non-Inferiority:** False ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.070 - **Upper Limit:** - **Value:** 0.054 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.069 - **Upper Limit:** - **Value:** 0.051 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.075 - **Upper Limit:** - **Value:** 1.2 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.076 - **Upper Limit:** - **Value:** 0.93 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.028 - **Upper Limit:** - **Value:** 0.61 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.027 - **Upper Limit:** - **Value:** 0.54 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.051 - **Upper Limit:** - **Value:** 11.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.050 - **Upper Limit:** - **Value:** 10.9 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.061 - **Upper Limit:** - **Value:** 7.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.060 - **Upper Limit:** - **Value:** 7.3 **Title:** #### Outcome Measure 6 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.097 - **Upper Limit:** - **Value:** 1.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.098 - **Upper Limit:** - **Value:** 1.6 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** log-transformed serum Interleukin-6 (IL-6) Serum cytokine levels provide an assessment of systemic inflammation, the cytokine level circulating throughout the body. Higher levels are typically interrupted as worse unless an individual is acutely ill. Stimulated cytokine production reflects the inflammatory cytokine production capacity of monocytes. **Dispersion Type:** Standard Error **Parameter Type:** LEAST_SQUARES_MEAN **Population Description:** intention to treat **Reporting Status:** POSTED **Time Frame:** every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points) **Title:** Serum ln(IL-6) **Type:** PRIMARY **Unit of Measure:** ln(pg/mL) ##### Group **Description:** Placebo oral Omega-3 fish oil supplementation **ID:** OG000 **Title:** Placebo ##### Group **Description:** oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid \[EPA\] and 348 mg of docosahexaenoic acid \[DHA\]) **ID:** OG001 **Title:** Omega-3 Fish Oil Supplement #### Outcome Measure 2 **Description:** log-transformed Beck anxiety score, min-max values - 0-4.1: higher means greater anxiety **Dispersion Type:** Standard Error **Parameter Type:** LEAST_SQUARES_MEAN **Population Description:** intention to treat **Reporting Status:** POSTED **Time Frame:** every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points) **Title:** ln(Beck Anxiety Score) **Type:** SECONDARY **Unit of Measure:** units ##### Group **Description:** Placebo oral Omega-3 fish oil supplementation **ID:** OG000 **Title:** Placebo ##### Group **Description:** oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid \[EPA\] and 348 mg of docosahexaenoic acid \[DHA\]) **ID:** OG001 **Title:** Omega-3 Fish Oil Supplement #### Outcome Measure 3 **Description:** log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha) All cytokine measurements (e.g., IL-6 and TNF-a, serum and stimulated) were analyzed across time; however, no stress effects were found. Therefore, all assessments post-supplementation were averaged (time points 3-6) and analyzed to determine whether fish oil supplementation had an effect. Pooling these 4 assessments provides a better estimate of an individual's cytokine levels because single time point measurements can be affected by changes in exercise, alcohol consumption, or sleep in the preceding 24-48 hours. **Dispersion Type:** Standard Error **Parameter Type:** LEAST_SQUARES_MEAN **Population Description:** intention to treat **Reporting Status:** POSTED **Time Frame:** every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points) **Title:** Serum ln(TNF-a) **Type:** PRIMARY **Unit of Measure:** ln(pg/mL) ##### Group **Description:** Placebo oral Omega-3 fish oil supplementation **ID:** OG000 **Title:** Placebo ##### Group **Description:** oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid \[EPA\] and 348 mg of docosahexaenoic acid \[DHA\]) **ID:** OG001 **Title:** Omega-3 Fish Oil Supplement #### Outcome Measure 4 **Description:** log-transformed stimulated IL-6 Serum cytokine levels provide an assessment of systemic inflammation, the cytokine level circulating throughout the body. Higher levels are typically interrupted as worse unless an individual is acutely ill. Stimulated cytokine production reflects the inflammatory cytokine production capacity of monocytes. **Dispersion Type:** Standard Error **Parameter Type:** LEAST_SQUARES_MEAN **Population Description:** intent to treat **Reporting Status:** POSTED **Time Frame:** every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points) **Title:** Stimulated ln(IL-6) **Type:** PRIMARY **Unit of Measure:** ln(pg/mL) ##### Group **Description:** Placebo oral Omega-3 fish oil supplementation **ID:** OG000 **Title:** Placebo ##### Group **Description:** oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid \[EPA\] and 348 mg of docosahexaenoic acid \[DHA\]) **ID:** OG001 **Title:** Omega-3 Fish Oil Supplement #### Outcome Measure 5 **Description:** log-transformed stimulated TNF-alpha **Dispersion Type:** Standard Error **Parameter Type:** LEAST_SQUARES_MEAN **Population Description:** intention to treat **Reporting Status:** POSTED **Time Frame:** every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points) **Title:** Stimulated ln(TNF-alpha) **Type:** PRIMARY **Unit of Measure:** ln(pg/mL) ##### Group **Description:** Placebo oral Omega-3 fish oil supplementation **ID:** OG000 **Title:** Placebo ##### Group **Description:** oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid \[EPA\] and 348 mg of docosahexaenoic acid \[DHA\]) **ID:** OG001 **Title:** Omega-3 Fish Oil Supplement #### Outcome Measure 6 **Description:** log-transformed Center for Epidemiologic Studies Depression Scale (CES-D) score The CES-D is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale. Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms. **Dispersion Type:** Standard Error **Parameter Type:** LEAST_SQUARES_MEAN **Population Description:** intention to treat **Reporting Status:** POSTED **Time Frame:** every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points) **Title:** ln(CES-D) **Type:** SECONDARY **Unit of Measure:** scores on a ##### Group **Description:** Placebo oral Omega-3 fish oil supplementation **ID:** OG000 **Title:** Placebo ##### Group **Description:** oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid \[EPA\] and 348 mg of docosahexaenoic acid \[DHA\]) **ID:** OG001 **Title:** Omega-3 Fish Oil Supplement ### Participant Flow Module #### Group **Description:** Placebo oral Omega-3 fish oil supplementation **ID:** FG000 **Title:** Placebo #### Group **Description:** oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid \[EPA\] and 348 mg of docosahexaenoic acid \[DHA\]) **ID:** FG001 **Title:** Omega-3 Fish Oil Supplement #### Period **Title:** Overall Study ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 0 ###### Reason **Group ID:** FG001 **Number of Subjects:** 1 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 34 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 34 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 34 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 33 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 1 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT02731079 **Brief Title:** Sleeve Gastrectomy Outcomes With Different Stapling Devices **Official Title:** Prospective Comparison of Sleeve Gastrectomy Outcomes With Different Stapling Devices #### Organization Study ID Info **ID:** WB16-08 #### Organization **Class:** FED **Full Name:** William Beaumont Army Medical Center ### Status Module #### Completion Date **Date:** 2021-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2018-11-06 **Type:** ACTUAL **Last Update Submit Date:** 2018-11-02 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2020-03 **Type:** ESTIMATED #### Start Date **Date:** 2018-01-22 **Type:** ACTUAL **Status Verified Date:** 2018-11 #### Study First Post Date **Date:** 2016-04-07 **Type:** ESTIMATED **Study First Submit Date:** 2016-03-30 **Study First Submit QC Date:** 2016-04-01 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** FED **Name:** William Beaumont Army Medical Center #### Responsible Party **Investigator Affiliation:** William Beaumont Army Medical Center **Investigator Full Name:** Eric P Ahnfeldt **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Sleeve gastrectomy is now the most commonly performed bariatric surgery. While many studies have evaluated factors that may minimize post-operative hemorrhage and staple-line leak, the investigators are unaware of any studies that compare outcomes between devices from the two main stapler manufacturers used in this surgery, Covidien and Ethicon. The purpose of this study is to compare intraoperative characteristics, such as time to create sleeve, intraoperative bleeding, and time needed to load each cartridge, and post-operative characteristics, such as any complication requiring readmission (leak or hemorrhage), further surgical intervention, and weight loss, between patients who underwent sleeve gastrectomy with Covidien devices and Ethicon devices. Currently the investigators predominantly use whatever device is cheaper, but cost should not be the primary decisive factor if one device is superior to the other. If one device has better clinical outcomes, it should be the preferred device regardless of cost. If neither proves superiority, the investigators can justify using cost to determine which device to use in patient care. **Detailed Description:** New bariatric patients who have elected for a sleeve gastrectomy as part of standard of care will be invited to participate in the study during the bariatric clinic at William Beaumont Army Medical Center. Patients who meet the inclusion criteria will be invited to participate in the study. These patients will be consented in the bariatric clinic by a research coordinator (Doreen Bandari-Spaulding) or physician listed on the study if the coordinator is unavailable. Three folders will be made, one for each bariatric surgeon, and 25 Covidien cards and 25 Ethicon cards will be placed into each for a total of 150 patients. All bariatric surgeons are trained and familiar with both devices. Once consented, a card will be removed at random to determine which stapler will be used. Bioabsorbable staple line reinforcement will be utilized with both staplers. Once in the operating room, the case start time, time from first staple firing to completion of sleeve, total stapler loads required, number of staple misfires, character of any staple line bleeding, and time for tech to load each cartridge will be recorded on a data collection sheet by a research resident, listed as an associative investigator on this protocol. The subject's post-operative course will follow the bariatric protocol. During follow-up, they will be monitored for weight loss, post-operative complications, and any other required interventions. This information will be obtained by reviewing the subject's medical record after follow-up appointments. Per the institutional bariatric protocol, subjects will follow-up at 3 weeks, 6 weeks, 3 months, 6 months, and annually. If a subject withdraws consent for the study prior to surgery, they will still receive surgery and perioperative treatment in line with institutional protocol, and they will be withdrawn and create a vacancy for a new subject. If a subject withdraws consent after surgery, data collection will cease for that subject. The investigators will clarify whether they want all data to be removed from the study or if they simply want no more data to be entered into the study and abide by their wishes, and they will remain in the original randomized group in accordance with intention-to-treat principles. ### Conditions Module **Conditions:** - Morbid Obesity **Keywords:** - Sleeve gastrectomy stapler Covidien Ethicon bleeding leak ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Group that will have sleeve gastrectomy performed using the Covidien iDrive powered stapler with absorbable polymer membrane staple line reinforcement. **Intervention Names:** - Device: Covidien iDrive **Label:** Covidien **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Group that will have sleeve gastrectomy performed using the Ethicon Echilon powered stapler with absorbable polymer membrane staple line reinforcement. **Intervention Names:** - Device: Ethicon Echilon **Label:** Ethicon **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Covidien **Description:** Surgery performed with Covidien powered stapler **Name:** Covidien iDrive **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Ethicon **Description:** Surgery performed with Ethicon powered stapler **Name:** Ethicon Echilon **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Measure:** Time to create sleeve **Time Frame:** Time from first staple firing to last staple firing, for up to 5 hours **Measure:** Percent of staple firings with technical difficulties **Time Frame:** Time from first staple firing to last staple firing, for up to 5 hours **Measure:** Time to load staple cartridges **Time Frame:** Time from first staple firing to last staple firing, for up to 5 hours #### Secondary Outcomes **Description:** Will note any incidental bleeding along staple line and how many maneuvers were needed to control it. Measured as: 1) None, 2) Single therapy, 3) Multiple therapy (Any combination of hemostatic modalities) **Measure:** Intra-operative staple line bleeding **Time Frame:** Time from first staple firing to end of the case, for up to 5 hours **Measure:** Weight loss in percent excess body weight loss at 3 weeks, 6 weeks, 3 months, 6 months, and up to 1 year **Time Frame:** Pre-operative appointment to up to 1 year post-operative, for up to 1 year after sleeve creation **Measure:** Staple line leak rates **Time Frame:** Immediate post-operative period to conclusion of study, for up to 5 hours **Description:** Will note reason for readmission **Measure:** Hospital readmissions or emergency room visits **Time Frame:** Immediate post-operative period to conclusion of study, for up to 30 days after sleeve creation **Description:** Will note intervention required and indication; reasons include, but are not limiting to, staple line leak, hematoma, abscess, prolonged tachycardia suspicious for intra-abdominal pathology **Measure:** Sleeve-related complications requiring surgery, recorded as yes or no **Time Frame:** Immediate post-operative period to conclusion of study, for up to 1 year after sleeve creation ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Informed consent obtained and signed from each subject 2. Age ≥ 18 years 3. Requirement for agreement to avoid conception 4. BMI \>40 5. BMI \>35 with obesity-related co-morbidity 6. Pre-operative psychiatric evaluation 7. Pre-operative laboratory studies that fail to demonstrate secondary cause of obesity 8. Full course of triple therapy for patients with Helicobacter pylori on upper endoscopy Exclusion Criteria: 1. Pregnancy- Patients are not eligible for bariatric surgery, and if they become pregnant after surgery, they would present confounding variables and alter weight loss 2. Tobacco use within one month of surgery or any time within study period- Most staff will not perform bariatric surgery on active smokers as it negatively impacts healing 3. Prior bariatric surgery- Makes repeat bariatric surgery more difficult and could increase risk of complications 4. Inflammatory bowel disease- Rare diagnosis that may increase chance of complications, thus confounding results 5. Active duty military- Not eligible for bariatric surgery **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Chelsey A McKinnon, MD **Phone:** 915 742 2282 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Daniel J Roubik, MD **Phone:** 915-742-2282 **Role:** CONTACT #### Locations **Location 1:** **City:** El Paso **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Eric P Ahnfeldt, DO - **Phone:** 915-742-4442 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Cara L Reitz, MD - **Phone:** 5617045490 - **Role:** CONTACT **Country:** United States **Facility:** William Beaumont Army Medical Center **State:** Texas **Status:** RECRUITING **Zip:** 79934 #### Overall Officials **Official 1:** **Affiliation:** Residency Program Director **Name:** Eric P Ahnfeldt, DO **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732. **PMID:** 24570244 **Citation:** Nguyen NT, Nguyen B, Gebhart A, Hohmann S. Changes in the makeup of bariatric surgery: a national increase in use of laparoscopic sleeve gastrectomy. J Am Coll Surg. 2013 Feb;216(2):252-7. doi: 10.1016/j.jamcollsurg.2012.10.003. Epub 2012 Nov 21. **PMID:** 23177371 **Citation:** Marceau P, Hould FS, Simard S, Lebel S, Bourque RA, Potvin M, Biron S. Biliopancreatic diversion with duodenal switch. World J Surg. 1998 Sep;22(9):947-54. doi: 10.1007/s002689900498. **PMID:** 9717420 **Citation:** Ren CJ, Patterson E, Gagner M. Early results of laparoscopic biliopancreatic diversion with duodenal switch: a case series of 40 consecutive patients. Obes Surg. 2000 Dec;10(6):514-23; discussion 524. doi: 10.1381/096089200321593715. **PMID:** 11175958 **Citation:** Regan JP, Inabnet WB, Gagner M, Pomp A. Early experience with two-stage laparoscopic Roux-en-Y gastric bypass as an alternative in the super-super obese patient. Obes Surg. 2003 Dec;13(6):861-4. doi: 10.1381/096089203322618669. **PMID:** 14738671 **Citation:** ASMBS Clinical Issues Committee. Updated position statement on sleeve gastrectomy as a bariatric procedure. Surg Obes Relat Dis. 2012 May-Jun;8(3):e21-6. doi: 10.1016/j.soard.2012.02.001. Epub 2012 Feb 10. No abstract available. **PMID:** 22417852 **Citation:** D'Ugo S, Gentileschi P, Benavoli D, Cerci M, Gaspari A, Berta RD, Moretto C, Bellini R, Basso N, Casella G, Soricelli E, Cutolo P, Formisano G, Angrisani L, Anselmino M. Comparative use of different techniques for leak and bleeding prevention during laparoscopic sleeve gastrectomy: a multicenter study. Surg Obes Relat Dis. 2014 May-Jun;10(3):450-4. doi: 10.1016/j.soard.2013.10.018. Epub 2013 Nov 12. **PMID:** 24448100 **Citation:** Gentileschi P, Camperchioli I, D'Ugo S, Benavoli D, Gaspari AL. Staple-line reinforcement during laparoscopic sleeve gastrectomy using three different techniques: a randomized trial. Surg Endosc. 2012 Sep;26(9):2623-9. doi: 10.1007/s00464-012-2243-2. Epub 2012 Mar 23. **PMID:** 22441975 **Citation:** Glaysher M, Khan OA, Mabvuure NT, Wan A, Reddy M, Vasilikostas G. Staple line reinforcement during laparoscopic sleeve gastrectomy: does it affect clinical outcomes? Int J Surg. 2013;11(4):286-9. doi: 10.1016/j.ijsu.2013.02.015. Epub 2013 Feb 28. **PMID:** 23459188 **Citation:** Sroka G, Milevski D, Shteinberg D, Mady H, Matter I. Minimizing Hemorrhagic Complications in Laparoscopic Sleeve Gastrectomy--a Randomized Controlled Trial. Obes Surg. 2015 Sep;25(9):1577-83. doi: 10.1007/s11695-015-1580-3. **PMID:** 25596939 **Citation:** Gagner M, Buchwald JN. Comparison of laparoscopic sleeve gastrectomy leak rates in four staple-line reinforcement options: a systematic review. Surg Obes Relat Dis. 2014 Jul-Aug;10(4):713-23. doi: 10.1016/j.soard.2014.01.016. Epub 2014 Jan 28. **PMID:** 24745978 **Citation:** Huang R, Gagner M. A Thickness Calibration Device Is Needed to Determine Staple Height and Avoid Leaks in Laparoscopic Sleeve Gastrectomy. Obes Surg. 2015 Dec;25(12):2360-7. doi: 10.1007/s11695-015-1705-8. **PMID:** 26024735 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009765 - Term: Obesity - ID: D000050177 - Term: Overweight - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M9556 - Name: Hemorrhage - Relevance: LOW - As Found: Unknown - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M12702 - Name: Obesity, Morbid - Relevance: HIGH - As Found: Morbid Obesity - ID: M26186 - Name: Overweight - Relevance: LOW - As Found: Unknown - ID: M25307 - Name: Overnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009767 - Term: Obesity, Morbid ### Misc Info Module #### Submission Tracking - Estimated Results First Submit Date: 2024-02-16 ##### Submission Infos - MCP Release N: 2 - Release Date: 2024-02-16 - Reset Date: 2024-03-13 - Unrelease Date: Unknown - Unrelease Date Unknown: Unknown - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01057979 **Acronym:** MILE **Brief Title:** Motivational Interventions for Lifestyle and Exercise in College Students **Official Title:** Motivational Interventions for Exercise in Hazardous Drinking College Students #### Organization Study ID Info **ID:** H09-043 #### Organization **Class:** OTHER **Full Name:** University of Connecticut #### Secondary ID Infos **ID:** R21AA017717-01A1 **Link:** https://reporter.nih.gov/quickSearch/R21AA017717-01A1 **Type:** NIH ### Status Module #### Completion Date **Date:** 2011-10 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-10-06 **Type:** ACTUAL **Last Update Submit Date:** 2021-09-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2011-10 **Type:** ACTUAL #### Start Date **Date:** 2010-01 **Status Verified Date:** 2021-09 #### Study First Post Date **Date:** 2010-01-28 **Type:** ESTIMATED **Study First Submit Date:** 2010-01-26 **Study First Submit QC Date:** 2010-01-27 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institute on Alcohol Abuse and Alcoholism (NIAAA) #### Lead Sponsor **Class:** OTHER **Name:** University of Connecticut #### Responsible Party **Investigator Affiliation:** University of Connecticut **Investigator Full Name:** Linda Pescatello **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** Engagement in substance-free activities, such as exercise, has an inverse relationship to substance use in college students. While exercise has numerous physical and mental health benefits, the majority of college students are sedentary, infrequently engaging in exercise. Although exercise interventions to date often suffer from significant attrition and poor adherence, motivational interventions for exercise are beginning to show promise. In this pilot study we propose to develop and evaluate a novel exercise intervention combining Motivational Enhancement Therapy (MET) with contingency management (CM) in sedentary college students who use alcohol. ### Conditions Module **Conditions:** - Alcohol Consumption **Keywords:** - exercise - college students - Sedentary college students ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 72 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Motivational Enhancement Therapy seeks to resolve ambivalence regarding exercise and increase intrinsic motivation to exercise. Contingency management offers tangible rewards for completing verified exercise. **Intervention Names:** - Behavioral: MET + CM for Exercise **Label:** MET + CM for Exercise **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Motivational Enhancement Therapy seeks to resolve ambivalence regarding exercise and increase intrinsic motivation to exercise. Exercise contracting consists of weekly appointment to set specific goals for exercise in the upcoming week. **Intervention Names:** - Behavioral: MET + Exercise Contracting **Label:** MET + Exercise Contracting **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - MET + CM for Exercise **Description:** Motivational Enhancement Therapy seeks to resolve ambivalence regarding exercise and increase intrinsic motivation to exercise. Contingency management offers tangible rewards for completing verified exercise. **Name:** MET + CM for Exercise **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - MET + Exercise Contracting **Description:** Motivational Enhancement Therapy seeks to resolve ambivalence regarding exercise and increase intrinsic motivation to exercise. Exercise contracting consists of weekly appointment to set specific goals for exercise in the upcoming week. **Name:** MET + Exercise Contracting **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Measure:** Exercise engagement **Time Frame:** 2 month, 6 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Sedentary college students who drink alcohol. Exclusion Criteria: * Medical contraindications for exercise. **Healthy Volunteers:** True **Maximum Age:** 26 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Storrs **Country:** United States **Facility:** University of Connecticut Storrs **State:** Connecticut **Zip:** 06269 #### Overall Officials **Official 1:** **Affiliation:** St. Louis University **Name:** Jeremiah Weinstock, Ph.D. **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Weinstock J, Petry NM, Pescatello LS, Henderson CE. Sedentary college student drinkers can start exercising and reduce drinking after intervention. Psychol Addict Behav. 2016 Dec;30(8):791-801. doi: 10.1037/adb0000207. Epub 2016 Sep 26. **PMID:** 27669095 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004327 - Term: Drinking Behavior ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M3774 - Name: Alcohol Drinking - Relevance: HIGH - As Found: Alcohol Consumption - ID: M7502 - Name: Drinking Behavior - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000428 - Term: Alcohol Drinking ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00400179 **Brief Title:** A Safety and Efficacy Study in Patients With Gastric Cancer **Official Title:** An Open-Label Multicenter, Randomized, Phase 3 Study of S-1 in Combination With Cisplatin Against 5-Fu in Combination W/ Cisplatin in Patients W/ Advanced Gastric Cancer Previously Untreated W/ Chemotherapy for Advanced Disease **NCT ID Aliases:** - NCT00128609 #### Organization Study ID Info **ID:** TPU S-1301 #### Organization **Class:** INDUSTRY **Full Name:** Taiho Oncology, Inc. ### Status Module #### Completion Date **Date:** 2008-04 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2020-08-14 **Type:** ACTUAL **Last Update Submit Date:** 2020-08-04 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2008-03 **Type:** ACTUAL #### Results First Post Date **Date:** 2012-04-23 **Type:** ESTIMATED **Results First Submit Date:** 2012-01-06 **Results First Submit QC Date:** 2012-03-28 #### Start Date **Date:** 2005-05 **Status Verified Date:** 2020-08 #### Study First Post Date **Date:** 2006-11-16 **Type:** ESTIMATED **Study First Submit Date:** 2005-06-30 **Study First Submit QC Date:** 2006-11-15 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Quintiles, Inc. #### Lead Sponsor **Class:** INDUSTRY **Name:** Taiho Oncology, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is an open-label, international, two-arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of S-1/cisplatin versus 5-FU/cisplatin in patients with advanced gastric cancer previously untreated with chemotherapy for advanced disease. Patients will be randomly assigned (1:1) to S-1/cisplatin (experimental arm) or 5-FU/cisplatin (control arm). Patients will be stratified by number of metastatic sites (one vs. more than one), locally advanced or metastatic disease, prior adjuvant therapy (yes or no), measurable or non-measurable disease, and center. ### Conditions Module **Conditions:** - Gastric Cancer **Keywords:** - Gastric Cancer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 1053 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In Arm A, S-1 25 mg/m² was administered orally BID from Day 1 through Day 21 followed by a recovery period from Days 22 through Day 28. On Day 1, the morning dose of S-1 was administered before cisplatin 75 mg/m2 administration as a 1- to 3-hour IV infusion. This regimen was repeated every 4 weeks. S-1 was administered one hour before or one hour after a meal with a glass of water (approximately 100 mL). **Intervention Names:** - Drug: S-1/Cisplatin **Label:** A **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** In Arm B, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion (CIV) over 120 hours (on Days 1 through 5). This regimen was repeated every 4 weeks. 5-FU CIV followed cisplatin infusion on Day 1. All 5-FU used in this study was commercially available product. **Intervention Names:** - Drug: 5-FU/cisplatin **Label:** B **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - A **Description:** In Arm A, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth (NPO 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with approximately 8 ounces of water and prior to cisplatin infusion on Day 1. Cisplatin 75 mg/m2 was administered as a 1- to 3-hour IV infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment for cisplatin. **Name:** S-1/Cisplatin **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - B **Description:** In Arm B, 5-FU 1000 mg/m2/24 hours was administered CIV on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment for cisplatin. **Name:** 5-FU/cisplatin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Survival was defined as the time from the date of randomization to the time of death (from any cause) for each patient. **Measure:** Median Survival **Time Frame:** The cutoff date for survival analysis was 07 March 2008 (12 months after last patient randomized). #### Secondary Outcomes **Description:** The proportion of patients with objective evidence of complete response (CR) or partial response (PR) based on tumor response assessments. Per the Response Evaluation Criteria in Solid tumors (RECIST), CR was defined as the disappearance of all target lesions for at least 4 weeks, and PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions. **Measure:** Overall Response Rate (ORR) **Time Frame:** Data cutoff was 07 March 2008 (12 months after last patient randomized). **Description:** Duration of response was defined as the time from date of first confirmed response (CR or PR) to date of first progressive disease (PD) or death. Per the RECIST criteria, definitions were as follows: CR was the disappearance of all target lesions for at least 4 weeks, PR was at least a 30% decrease in the sum of the longest diameter of target lesions, and PD was at least a 20% increase in the sum of the longest diameter of target lesions. **Measure:** Duration of Response (DR) **Time Frame:** Data cutoff was 07 March 2008 (12 months after last patient was randomized). **Description:** The time from randomization to date of first documented PD or date of death, whichever occurred first. **Measure:** Progression-free Survival (PFS) **Time Frame:** From date of randomization until date of first documented PD, date of death, or until data cutoff on 07 March 2008 (12 months after last patient randomized), whichever came first. **Description:** The time from randomization to date of permanent discontinuation of S-1 or 5-FU, first documented PD, or death, whichever occurred first. **Measure:** Time to Treatment Failure (TTF) **Time Frame:** From date of randomization until date of permanent discontinuation of S-1 or 5-FU, first documented PD, death, or data cutoff on 07 March 2008 (12 months after last patient randomized), whichever came first. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study: * Has given written informed consent * Has histologically confirmed, unresectable, locally advanced (Stage IV) or metastatic gastric cancer, including adenocarcinoma of the gastro-esophageal junction * Has measurable or evaluable but non-measurable disease, defined as follows: * Measurable Disease - Patients with measurable disease as defined by RECIST criteria, i.e., the presence of at least one measurable lesion. A measurable lesion is one that can be accurately measured in at least one dimension with the longest diameter \>_ 20 mm using conventional techniques or \>_ 10 mm using spiral Computed Tomography (CT)scan. Locally recurrent disease (other than primary) is accepted if there is at least one measurable lesion (i.e. peritoneal mass, lymph node, etc.) * Evaluable but Non-measurable Disease - Patients with all lesions below the limits defined above for measureable disease (i.e., longest diameter \< 20 mm with conventional techniques or \< 10 mm with spiral CT) excluding those patients with only a primary lesion and/or with only non-evaluable cancer such as bone metastases, ascites, pleural or pericardia effusions, lymphangitic carcinomatosis of the skin or lung, previously irradiated lesions not in progression, or peritoneal carcinomatosis \< 10 mm in diameter with conventional imaging techniques. * No prior palliative chemotherapy is permitted. Adjuvant and /or neo-adjuvant chemotherapy is permitted if more than 12 months have elapsed between the end of adjuvant or neo-adjuvant therapy and first recurrence. This does not qualify as 1st line therapy. * Is able to take medications orally * Is \>_ 18 years of age * Is at least 3 weeks from prior major surgery * Is at least 4 weeks from prior radiotherapy * Has a ECOG performance status 0 to 1 * Has adequate organ function as defined by the following criteria: * AST (SGOT) and ALT (SGPT) \<_ 2.5 x ULN; if liver function abnormalities are due to underlying liver metastasis, AST (SGOT) and ALT (SGPT) \<_ 5 x ULN * Total serum bilirubin of \<_ 1.5 x ULN * Absolute granulocyte count of \>_ 1,500/mm (i.e. \>_ 1.5 x 10/L by International Units (IU) * Platelet count \>_ 100,000/mm (IU: \>_ 100 x 10/L * Hemoglobin value of \>_ 9.0 g/dL * Calculated creatinine clearance \>_ 60 mL/min (Cockcroft-Gault formula) * Is willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures Exclusion Criteria: Exclude a patient from this study if he/she does not fulfill the inclusion criteria, or if any of the following conditions are observed: * Has had a treatment with any of the following within the specified timeframe prior to study drug administration: * Any prior palliative chemotherapy or any previous therapy for malignancy, including any chemotherapy, immunotherapy, biologic or hormonal therapy, within the past 5 years. * Adjuvant or neo-adjuvant therapy within the past 12 months * Concurrent treatment with any investigational anti-cancer agent * Prior cisplatin as neo-adjuvant and /or adjuvant chemotherapy with cumulative dose \> 300 mg/m * \> 25% of marrow-bearing bone radiated * Concurrent treatment with an investigational agent or within 30 days from randomization * Concurrent enrollment in another clinical study * Has a serious illness or medical condition(s) including, but not limited to the following: * Known brain or leptomeningeal metastases * Uncontrolled ascites requiring drainage at least twice a week * Other malignancies within the past 5 years, except adequately treated carcinoma-in-situ of the cervix or non-melanoma skin cancer * Myocardial infarction within the last 6 months, severe/unstable angina, congestive heart failure New York Heart Association (NYHA) class III or IV * Chronic nausea, vomiting or diarrhea * Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS-related illness * Psychiatric disorder that may interfere with consent and/or protocol compliance * Known neuropathy, Grade 2 or higher * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgement of the Investigator would make the patient inappropriate for entry into this study * Is receiving concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1: * Sorivudine, uracil, cimetidine, folinic acid, and dipyridamole (may enhance S-1 activity) * Allopurinol (may diminish S-1 activity * Phenytoin (S-1 may enhance phenytoin activity) * Flucytosine, a fluorinated pyrimidine antifungal agent (may enhance S-1 activity) * Is receiving concomitant treatment with drugs interacting with 5-FU: * Sorivudine, uracil, cimetidine, folinic acid, and dipyridamole(may enhance 5-FU activity) * Allopurinol (may diminish 5-FU activity) * Phenytoin (5-FU may enhance phenytoin activity) * Is receiving concomitant treatment with drugs interacting with cisplatin: * Phenytoin (cisplatin may diminish phenytoin activity) * Aminoglycosides (should be avoided within 8 days after cisplatin administration) * Ethyol (may diminish cisplatin activity * Is a pregnant or lactating female * Has known hypersensitivity to 5-FU or cisplatin * Patients with reproductive potential who refuse to use an adequate means of contraception (including male patients) **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Huntsville **Country:** United States **Facility:** Clearview Cancer Center **State:** Alabama **Zip:** 35801 **Location 2:** **City:** Burbank **Country:** United States **Facility:** Saint Joseph Medical Center **State:** California **Zip:** 91505 **Location 3:** **City:** Gilroy **Country:** United States **Facility:** Dr. Ronald Yanagihara **State:** California **Zip:** 95020 **Location 4:** **City:** Los Angeles **Country:** United States **Facility:** Norris Cancer Center **State:** California **Zip:** 90033 **Location 5:** **City:** Palm Springs **Country:** United States **Facility:** Comprehensive Cancer Center **State:** California **Zip:** 92262 **Location 6:** **City:** San Francisco **Country:** United States **Facility:** Saint Francis Memorial Hospital **State:** California **Zip:** 94109 **Location 7:** **City:** Santa Monica **Country:** United States **Facility:** Premiere Oncology **State:** California **Zip:** 90404 **Location 8:** **City:** Lakewood **Country:** United States **Facility:** Western Hematology/Oncology **State:** Colorado **Zip:** 80215 **Location 9:** **City:** Fort Lauderdale **Country:** United States **Facility:** Broward Oncology Associates **State:** Florida **Zip:** 33308 **Location 10:** **City:** Tampa **Country:** United States **Facility:** Alexandar Rosemurgy **State:** Florida **Zip:** 33606 **Location 11:** **City:** West Palm Beach **Country:** United States **Facility:** Palm Beach Cancer Institute **State:** Florida **Zip:** 33401 **Location 12:** **City:** Honolulu **Country:** United States **Facility:** Straub Clinic and Hospital **State:** Hawaii **Zip:** 96813 **Location 13:** **City:** Chicago **Country:** United States **Facility:** Robert H. Lurie Comprehensive Cancer Center **State:** Illinois **Zip:** 60611 **Location 14:** **City:** Chicago **Country:** United States **Facility:** University of Chicago Medical Center **State:** Illinois **Zip:** 60637-1470 **Location 15:** **City:** Metairie **Country:** United States **Facility:** Oncology and Hematology **State:** Louisiana **Zip:** 70006 **Location 16:** **City:** Duluth **Country:** United States **Facility:** St. Lukes Cancer Care Center **State:** Minnesota **Zip:** 55802 **Location 17:** **City:** Saint Louis **Country:** United States **Facility:** Neuroscience Center **State:** Missouri **Zip:** 63110 **Location 18:** **City:** Saint Louis **Country:** United States **Facility:** St. Louis University Cancer Center **State:** Missouri **Zip:** 63110 **Location 19:** **City:** Las Vegas **Country:** United States **Facility:** Southern Nevada Cancer Research Foundation **State:** Nevada **Zip:** 89106 **Location 20:** **City:** Albuquerque **Country:** United States **Facility:** AHS Lovelace Medical Group,LLC **State:** New Mexico **Zip:** 87102 **Location 21:** **City:** Albuquerque **Country:** United States **Facility:** New Mexico Cancer Center Associates **State:** New Mexico **Zip:** 87106 **Location 22:** **City:** Albuquerque **Country:** United States **Facility:** University of New Mexico **State:** New Mexico **Zip:** 87106 **Location 23:** **City:** Hawthorne **Country:** United States **Facility:** Hoo Chun, MD **State:** New York **Zip:** 10532 **Location 24:** **City:** New City **Country:** United States **Facility:** Hematology/Oncology Associates of Rockland **State:** New York **Zip:** 10956 **Location 25:** **City:** New Bern **Country:** United States **Facility:** New Bern Cancer Care **State:** North Carolina **Zip:** 28560 **Location 26:** **City:** Philadelphia **Country:** United States **Facility:** Abramson Cancer Center **State:** Pennsylvania **Zip:** 19104 **Location 27:** **City:** Philadelphia **Country:** United States **Facility:** Thomas Jefferson University **State:** Pennsylvania **Zip:** 19107 **Location 28:** **City:** Charleston **Country:** United States **Facility:** Charleston Cancer Center **State:** South Carolina **Zip:** 29406 **Location 29:** **City:** Chattanooga **Country:** United States **Facility:** Associates in Oncology and Hematology **State:** Tennessee **Zip:** 37404 **Location 30:** **City:** Chattanooga **Country:** United States **Facility:** Lexington Oncology Associates **State:** Tennessee **Zip:** 37404 **Location 31:** **City:** Houston **Country:** United States **Facility:** MD Anderson Cancer Center **State:** Texas **Zip:** 77030 **Location 32:** **City:** Madison **Country:** United States **Facility:** University of Wisconsin Comprehensive Cancer Center **State:** Wisconsin **Zip:** 53792 **Location 33:** **City:** Montreal **Country:** Canada **Facility:** CHUM Hopital Saint-Luc **State:** Quebec **Zip:** H2X3J4 #### Overall Officials **Official 1:** **Affiliation:** Taiho Oncology, Inc. **Name:** Fabio Benedetti, MD **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Bodoky G, Scheulen ME, Rivera F, Jassem J, Carrato A, Moiseyenko V, Vynnychenko I, Prausova J, Van Laethem JL, Cascinu S, Ajani JA. Clinical Benefit and Health-Related Quality of Life Assessment in Patients Treated with Cisplatin/S-1 Versus Cisplatin/5-FU: Secondary End Point Results From the First-Line Advanced Gastric Cancer Study (FLAGS). J Gastrointest Cancer. 2015 Jun;46(2):109-17. doi: 10.1007/s12029-014-9680-1. **PMID:** 25707610 **Citation:** Ajani JA, Buyse M, Lichinitser M, Gorbunova V, Bodoky G, Douillard JY, Cascinu S, Heinemann V, Zaucha R, Carrato A, Ferry D, Moiseyenko V. Combination of cisplatin/S-1 in the treatment of patients with advanced gastric or gastroesophageal adenocarcinoma: Results of noninferiority and safety analyses compared with cisplatin/5-fluorouracil in the First-Line Advanced Gastric Cancer Study. Eur J Cancer. 2013 Nov;49(17):3616-24. doi: 10.1016/j.ejca.2013.07.003. Epub 2013 Jul 27. **PMID:** 23899532 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000013272 - Term: Stomach Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16064 - Name: Stomach Neoplasms - Relevance: HIGH - As Found: Gastric Cancer - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M16062 - Name: Stomach Diseases - Relevance: LOW - As Found: Unknown - ID: T5486 - Name: Stomach Cancer - Relevance: HIGH - As Found: Gastric Cancer ### Condition Browse Module - Meshes - ID: D000013274 - Term: Stomach Neoplasms ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M8600 - Name: Fluorouracil - Relevance: LOW - As Found: Unknown - ID: M6182 - Name: Cisplatin - Relevance: HIGH - As Found: High ### Intervention Browse Module - Meshes - ID: D000002945 - Term: Cisplatin ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** S-1/Cisplatin **Description:** In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1. Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment. **ID:** EG000 **Other Num Affected:** 514 **Other Num at Risk:** 521 **Serious Number Affected:** 257 **Serious Number At Risk:** 521 **Title:** S-1/Cisplatin **Group ID:** EG001 **Title:** 5-FU/Cisplatin **Description:** In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles. **ID:** EG001 **Other Num Affected:** 504 **Other Num at Risk:** 508 **Serious Number Affected:** 248 **Serious Number At Risk:** 508 **Title:** 5-FU/Cisplatin **Frequency Threshold:** 3 #### Other Events **Term:** Anaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Neutropenia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Thrombocytopenia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Leukopenia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Lymphopenia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Granulocytopenia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Febrile neutropenia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Leukocytosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Tinnitus **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Ear and labyrinth disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Deafness **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Ear and labyrinth disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Lacrimation increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Vision blurred **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Nausea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Vomiting **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Diarrhoea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Abdominal pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Constipation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Abdominal pain upper **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Dyspepsia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Stomatitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Flatulence **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Dysphagia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Ascites **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Gastrointestinal haemorrhage **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Abdominal distension **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Gastrooesophageal reflux disease **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Fatigue **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Asthenia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Pyrexia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Disease progression **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Oedema peripheral **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Performance status decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Chest pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Mucosal inflammation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Chills **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Injection site reaction **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Hyperbilirubinaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Nasopharyngitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 **Term:** Oral candidiasis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 **Term:** Weight decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 **Term:** Creatinine renal clearance decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 **Term:** Blood creatinine increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 **Term:** Haemoglobin decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 **Term:** Aspartate aminotransferase increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 **Term:** Blood alkaline phosphatase increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 **Term:** Neutrophil count decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 **Term:** Alanine aminotransferase increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 **Term:** Blood LDH increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 **Term:** Blood urea increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 **Term:** Platelet count decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 **Term:** White blood cell count decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 **Term:** Glomerular filtration rate decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 **Term:** Anorexia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Dehydration **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Hypomagnesaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Hyponatraemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Hypokalaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Decreased appetite **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Hypoalbuminaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Hypocalcaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Hyperglycaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Hyperkalaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Hypophosphataemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Back pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Pain in extremity **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Myalgia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Dizziness **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Headache **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Dysgeusia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Peripheral sensory neuropathy **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Paraesthesia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Neuropathy peripheral **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Insomnia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Depression **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Anxiety **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Hiccups **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Cough **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Dyspnoea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Epistaxis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Pulmonary embolism **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Alopecia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Palmar-plantar erythrodysaesthesia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Skin hyperpigmentation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Rash **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Hyperhidrosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Hypotension **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Hypertension **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Deep vein thrombosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 11.0 **Term:** Phlebitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 11.0 #### Serious Events **Term:** Anaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 33 **Num At Risk:** 521 **Num Events:** 37 **Group ID:** EG001 **Num Affected:** 31 **Num At Risk:** 508 **Num Events:** 38 **Term:** Anaemia megaloblastic **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 2 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Bone marrow failure **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Disseminated intravascular coagulation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Febrile neutropenia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 8 **Num At Risk:** 521 **Num Events:** 8 **Group ID:** EG001 **Num Affected:** 31 **Num At Risk:** 508 **Num Events:** 34 **Term:** Haemorrhagic anaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Haemorrhagic diathesis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Leukopenia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 521 **Num Events:** 4 **Group ID:** EG001 **Num Affected:** 5 **Num At Risk:** 508 **Num Events:** 5 **Term:** Neutropenia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 8 **Num At Risk:** 521 **Num Events:** 8 **Group ID:** EG001 **Num Affected:** 31 **Num At Risk:** 508 **Num Events:** 34 **Term:** Pancytopenia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 521 **Num Events:** 5 **Group ID:** EG001 **Num Affected:** 4 **Num At Risk:** 508 **Num Events:** 4 **Term:** Thrombocytopenia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 11 **Num At Risk:** 521 **Num Events:** 11 **Group ID:** EG001 **Num Affected:** 17 **Num At Risk:** 508 **Num Events:** 18 **Term:** Acute left ventricular failure **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Acute myocardial infarction **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 521 **Num Events:** 3 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Angina pectoris **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 508 **Num Events:** 2 **Term:** Atrial fibrillation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 521 **Num Events:** 2 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Cardiac Arrest **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Cardiac failure **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Cardiopulmonary failure **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 508 **Num Events:** 2 **Term:** Myocardial infarction **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Myocardial ischaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Pericardial effusion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Ventricular fibrillation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Ventricular tachycardia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Deafness **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Ear and labyrinth disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Hypoacusis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Ear and labyrinth disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Adrenal haemorrhage **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Endocrine disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Visual acuity reduced **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Vitreious floaters **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Eye disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Abdominal distension **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Abdominal pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 12 **Num At Risk:** 521 **Num Events:** 13 **Group ID:** EG001 **Num Affected:** 7 **Num At Risk:** 508 **Num Events:** 7 **Term:** Abdominal pain upper **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Ascites **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 521 **Num Events:** 5 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 508 **Num Events:** 3 **Term:** Constipation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 521 **Num Events:** 3 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 508 **Num Events:** 3 **Term:** Diarrhoea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 9 **Num At Risk:** 521 **Num Events:** 9 **Group ID:** EG001 **Num Affected:** 13 **Num At Risk:** 508 **Num Events:** 13 **Term:** Dysphagia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 521 **Num Events:** 4 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Enteritis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Gastric haemorrhage **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 5 **Num At Risk:** 521 **Num Events:** 5 **Group ID:** EG001 **Num Affected:** 4 **Num At Risk:** 508 **Num Events:** 4 **Term:** Gastric perforation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 521 **Num Events:** 4 **Group ID:** EG001 **Num Affected:** 4 **Num At Risk:** 508 **Num Events:** 4 **Term:** Gastric stenosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Gastric ulcer haemorrhage **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Gastrointestinal haemorrhage **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 13 **Num At Risk:** 521 **Num Events:** 13 **Group ID:** EG001 **Num Affected:** 8 **Num At Risk:** 508 **Num Events:** 8 **Term:** Gastrointestinal hypomotility **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Gastrointestinal motility disorder **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Gastrointestinal obstruction **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 508 **Num Events:** 3 **Term:** Gastrointestinal perforation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Haematemesis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 521 **Num Events:** 2 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Ileus **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 5 **Num At Risk:** 521 **Num Events:** 6 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Ileus paralytic **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Intestinal haemorrhage **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Intestinal ischaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 521 **Num Events:** 2 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Intestinal obstruction **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 6 **Num At Risk:** 521 **Num Events:** 6 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 508 **Num Events:** 3 **Term:** Mechanical ileus **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Melaena **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Nausea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 17 **Num At Risk:** 521 **Num Events:** 18 **Group ID:** EG001 **Num Affected:** 10 **Num At Risk:** 508 **Num Events:** 13 **Term:** Obstruction gastric **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 6 **Num At Risk:** 521 **Num Events:** 6 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Odynophagia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Oesophageal obstruction **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Oesophageal spasm **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Oesophagitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Pancreatitis acute **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 508 **Num Events:** 4 **Term:** Periproctitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Peritonitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 508 **Num Events:** 2 **Term:** Prepyloric stenosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Retroperitoneal fibrosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Small intestinal obstruction **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 5 **Num At Risk:** 521 **Num Events:** 5 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 508 **Num Events:** 4 **Term:** Stomatitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 521 **Num Events:** 3 **Group ID:** EG001 **Num Affected:** 24 **Num At Risk:** 508 **Num Events:** 30 **Term:** Subileus **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 521 **Num Events:** 2 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Thrombosis mesenteric vessel **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Upper gastrointestinal haemorrhage **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 5 **Num At Risk:** 521 **Num Events:** 8 **Group ID:** EG001 **Num Affected:** 4 **Num At Risk:** 508 **Num Events:** 4 **Term:** Vomiting **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 23 **Num At Risk:** 521 **Num Events:** 23 **Group ID:** EG001 **Num Affected:** 17 **Num At Risk:** 508 **Num Events:** 21 **Term:** Asthenia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 521 **Num Events:** 4 **Group ID:** EG001 **Num Affected:** 4 **Num At Risk:** 508 **Num Events:** 4 **Term:** Catheter site pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 508 **Num Events:** 2 **Term:** Catheter thrombosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 508 **Num Events:** 2 **Term:** Chest pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Chills **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Death **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 9 **Num At Risk:** 521 **Num Events:** 9 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Disease progression **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 53 **Num At Risk:** 521 **Num Events:** 53 **Group ID:** EG001 **Num Affected:** 34 **Num At Risk:** 508 **Num Events:** 34 **Term:** Fatigue **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 8 **Num At Risk:** 521 **Num Events:** 10 **Group ID:** EG001 **Num Affected:** 6 **Num At Risk:** 508 **Num Events:** 7 **Term:** Generalised Oedema **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Hyperthermia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Malaise **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Mucosal inflammation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 521 **Num Events:** 2 **Group ID:** EG001 **Num Affected:** 10 **Num At Risk:** 508 **Num Events:** 11 **Term:** Multi-organ failure **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Non-cardiac chest pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Oedema peripheral **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Performance status decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 521 **Num Events:** 3 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Pyrexia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 10 **Num At Risk:** 521 **Num Events:** 10 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Sudden death **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 521 **Num Events:** 2 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 508 **Num Events:** 3 **Term:** Bile duct obstruction **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 521 **Num Events:** 2 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Bile duct stenosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Cholangitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Hepatic failure **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Hepatic function abnormal **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 521 **Num Events:** 2 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Hyperbilirubinaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 521 **Num Events:** 5 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Jaundice cholestatic **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Anal abscess **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Appendicitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 521 **Num Events:** 3 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Bacteraemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 521 **Num Events:** 2 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Bronchitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 521 **Num Events:** 3 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Broncopneumonia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 508 **Num Events:** 2 **Term:** Catheter related infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 4 **Num At Risk:** 508 **Num Events:** 4 **Term:** Catheter sepsis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Catheter site cellulitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Cellulitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 508 **Num Events:** 2 **Term:** Central line infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Clostridium difficile colitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Enterocolitis infectious **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Gastroenteritis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Gastrointestinal infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Genital candidiasis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Lobar pneumonia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 521 **Num Events:** 3 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 508 **Num Events:** 3 **Term:** Neutropenic sepsis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 521 **Num Events:** 3 **Group ID:** EG001 **Num Affected:** 5 **Num At Risk:** 508 **Num Events:** 5 **Term:** Oesophageal candidiasis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Oral candidiasis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 508 **Num Events:** 3 **Term:** Oral herpes **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Parotitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Peritonitis bacterial **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Pharyngitis streptococcal **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Pharyngotonsillitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Pneumonia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 6 **Num At Risk:** 521 **Num Events:** 6 **Group ID:** EG001 **Num Affected:** 6 **Num At Risk:** 508 **Num Events:** 6 **Term:** Pneumonia bacterial **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Postoperative wound infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Pyelonephritis acute **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Pyothorax **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Respiratory tract infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Sepsis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 521 **Num Events:** 4 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 508 **Num Events:** 3 **Term:** Septic shock **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 521 **Num Events:** 3 **Group ID:** EG001 **Num Affected:** 10 **Num At Risk:** 508 **Num Events:** 10 **Term:** Staphylococcal infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Tooth infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Upper respiratory tract infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Urinary tract infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Urosepsis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Vaginal infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Wound abscess **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Anastomotic complication **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Confusion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Device migration **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Drug toxicity **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Femoral neck fracture **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 508 **Num Events:** 2 **Term:** Femur fracture **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Head Injury **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Humerus fracture **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Incorrect dose administered **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Stent occlusion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Traumatic brain injury **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Alanine aminotransferase increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Aspartate aminotransferase increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Blood alkaline phosphatase increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Blood bilirubin increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Blood creatinine increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 5 **Num At Risk:** 521 **Num Events:** 5 **Group ID:** EG001 **Num Affected:** 4 **Num At Risk:** 508 **Num Events:** 4 **Term:** Blood potassium decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Creatinine renal clearance decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 508 **Num Events:** 2 **Term:** Glomerular filtration rate decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 508 **Num Events:** 2 **Term:** Haemoglobin decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 521 **Num Events:** 3 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Platelet count decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 508 **Num Events:** 2 **Term:** Urine electrolytes increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Weight decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Alkalosis hypochloraemic **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Anorexia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 7 **Num At Risk:** 521 **Num Events:** 8 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 508 **Num Events:** 2 **Term:** Cachexia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 2 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Decreased appetite **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Dehydration **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 21 **Num At Risk:** 521 **Num Events:** 21 **Group ID:** EG001 **Num Affected:** 32 **Num At Risk:** 508 **Num Events:** 41 **Term:** Diabetes mellitus **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Diabetic ketoacidosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 521 **Num Events:** 2 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Failure to thrive **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Hyperglycaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 508 **Num Events:** 3 **Term:** Hyperkalaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 521 **Num Events:** 2 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Hyperuricaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Hypoalbuminaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Hypocalcaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 4 **Num At Risk:** 508 **Num Events:** 4 **Term:** Hypoglycaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Hypokalaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 521 **Num Events:** 4 **Group ID:** EG001 **Num Affected:** 8 **Num At Risk:** 508 **Num Events:** 8 **Term:** Hypomagnesaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 508 **Num Events:** 2 **Term:** Hyponatraemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 2 **Group ID:** EG001 **Num Affected:** 6 **Num At Risk:** 508 **Num Events:** 6 **Term:** Hypophosphataemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 508 **Num Events:** 3 **Term:** Hypovolaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Malnutrition **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Metabolic acidosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Back pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 6 **Num At Risk:** 521 **Num Events:** 6 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Bone pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Musculoskeletal chest pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Pathological fracture **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Malignant ascites **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Malignant pleural effusion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Metastases to bladder **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Metastases to central nervous system **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Metastases to liver **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Metastases to ovary **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Metastases to spine **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Tumour associated fever **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 2 **Term:** Tumour haemorrhage **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 7 **Num At Risk:** 521 **Num Events:** 9 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 508 **Num Events:** 4 **Term:** Tumour lysis syndrome **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Tumour pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 521 **Num Events:** 2 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Tumour perforation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Acoustic neuritis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Cerebellar infarction **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Cerebral infarction **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Cerebral ischaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 508 **Num Events:** 2 **Term:** Cerebral thrombosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Cerebrovascular accident **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 521 **Num Events:** 3 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 508 **Num Events:** 4 **Term:** Cerebrovascular disorder **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Convulsion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 5 **Num At Risk:** 521 **Num Events:** 6 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 508 **Num Events:** 2 **Term:** Encephalopathy **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Grand mal convulsion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Hypotonia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Ischaemic cerebral infarction **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Ischaemic stroke **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 521 **Num Events:** 3 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Metabolic encephalopathy **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Neuropathy peripheral **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Peripheral sensory neuropathy **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Speech disorder **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Spinal cord compression **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 521 **Num Events:** 3 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 508 **Num Events:** 2 **Term:** Syncope **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Syncope vasovagal **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Confusional state **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Disorientation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Psychotic disorder **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Calculus urinary **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Hydronephrosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Incontinence **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Renal colic **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Renal disorder **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 508 **Num Events:** 2 **Term:** Renal failure **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 5 **Num At Risk:** 521 **Num Events:** 5 **Group ID:** EG001 **Num Affected:** 9 **Num At Risk:** 508 **Num Events:** 9 **Term:** Renal failure acute **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 521 **Num Events:** 4 **Group ID:** EG001 **Num Affected:** 11 **Num At Risk:** 508 **Num Events:** 11 **Term:** Renal failure chronic **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Renal impairment **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 521 **Num Events:** 2 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 508 **Num Events:** 3 **Term:** Renal tubular disorder **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Ureteric stenosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Chronic Obstructive Pulmonary Disease **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Dyspnoea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 521 **Num Events:** 4 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Haemoptysis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Hydrothorax **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Pharyngeal inflammation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Pleural effusion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 521 **Num Events:** 5 **Group ID:** EG001 **Num Affected:** 4 **Num At Risk:** 508 **Num Events:** 4 **Term:** Pneumonia aspiration **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Pneumothorax **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Pulmonary artery thrombosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Pulmonary embolism **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 12 **Num At Risk:** 521 **Num Events:** 12 **Group ID:** EG001 **Num Affected:** 8 **Num At Risk:** 508 **Num Events:** 8 **Term:** Respiratory failure **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Rash **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Aortic thrombosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Arterial thrombosis limb **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 521 **Num Events:** 2 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Circulatory collapse **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Deep vein thrombosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 5 **Num At Risk:** 521 **Num Events:** 5 **Group ID:** EG001 **Num Affected:** 17 **Num At Risk:** 508 **Num Events:** 18 **Term:** Haemorrhage **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 508 **Num Events:** 2 **Term:** Hypertension **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Hypertensive crisis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Hypotension **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 521 **Num Events:** 4 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 508 **Num Events:** 4 **Term:** Hypovolaemic shock **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 521 **Num Events:** 4 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Iliac artery thrombosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Pelvis venous thrombosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Peripheral embolism **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Subclavian vein thrombosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 521 **Num Events:** 2 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Thrombophlebitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Term:** Vena cava thrombosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 521 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 508 **Term:** Venous thrombosis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA 11.0 ##### Stats **Group ID:** EG000 **Num At Risk:** 521 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 508 **Num Events:** 1 **Time Frame:** From the start of study drug administration until 12 months after last patient randomized ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 521 **Group ID:** BG001 **Value:** 508 **Group ID:** BG002 **Value:** 1029 **Units:** Participants ### Group **ID:** BG000 **Title:** S-1/Cisplatin **Description:** In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1. Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment. ### Group **ID:** BG001 **Title:** 5-FU/Cisplatin **Description:** In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles. ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 18 **Upper Limit:** 83 **Value:** 59.0 #### Measurement **Group ID:** BG001 **Lower Limit:** 18 **Upper Limit:** 85 **Value:** 59.0 #### Measurement **Group ID:** BG002 **Lower Limit:** 18 **Upper Limit:** 85 **Value:** 59.0 **Class Title:** Baseline Measure Data (descriptive stats, median) ### Measure #### Measurement **Group ID:** BG000 **Value:** 139 #### Measurement **Group ID:** BG001 **Value:** 161 #### Measurement **Group ID:** BG002 **Value:** 300 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 382 #### Measurement **Group ID:** BG001 **Value:** 347 #### Measurement **Group ID:** BG002 **Value:** 729 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 4 #### Measurement **Group ID:** BG001 **Value:** 6 #### Measurement **Group ID:** BG002 **Value:** 10 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 4 #### Measurement **Group ID:** BG001 **Value:** 4 #### Measurement **Group ID:** BG002 **Value:** 8 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 5 #### Measurement **Group ID:** BG001 **Value:** 7 #### Measurement **Group ID:** BG002 **Value:** 12 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 447 #### Measurement **Group ID:** BG001 **Value:** 438 #### Measurement **Group ID:** BG002 **Value:** 885 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 61 #### Measurement **Group ID:** BG001 **Value:** 53 #### Measurement **Group ID:** BG002 **Value:** 114 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 4 #### Measurement **Group ID:** BG001 **Value:** 5 #### Measurement **Group ID:** BG002 **Value:** 9 **Class Title:** </=1.29 m2 #### Measurement **Group ID:** BG000 **Value:** 46 #### Measurement **Group ID:** BG001 **Value:** 44 #### Measurement **Group ID:** BG002 **Value:** 90 **Class Title:** 1.30-1.49 m2 #### Measurement **Group ID:** BG000 **Value:** 118 #### Measurement **Group ID:** BG001 **Value:** 147 #### Measurement **Group ID:** BG002 **Value:** 265 **Class Title:** 1.50-1.69 m2 #### Measurement **Group ID:** BG000 **Value:** 208 #### Measurement **Group ID:** BG001 **Value:** 181 #### Measurement **Group ID:** BG002 **Value:** 389 **Class Title:** 1.70-1.89 m2 #### Measurement **Group ID:** BG000 **Value:** 114 #### Measurement **Group ID:** BG001 **Value:** 93 #### Measurement **Group ID:** BG002 **Value:** 207 **Class Title:** 1.90-2.09 m2 #### Measurement **Group ID:** BG000 **Value:** 29 #### Measurement **Group ID:** BG001 **Value:** 34 #### Measurement **Group ID:** BG002 **Value:** 63 **Class Title:** 2.10-2.29 m2 #### Measurement **Group ID:** BG000 **Value:** 2 #### Measurement **Group ID:** BG001 **Value:** 4 #### Measurement **Group ID:** BG002 **Value:** 6 **Class Title:** >/=2.30 m2 ### Measure #### Measurement **Group ID:** BG000 **Value:** 226 #### Measurement **Group ID:** BG001 **Value:** 200 #### Measurement **Group ID:** BG002 **Value:** 426 **Class Title:** 0 #### Measurement **Group ID:** BG000 **Value:** 295 #### Measurement **Group ID:** BG001 **Value:** 308 #### Measurement **Group ID:** BG002 **Value:** 603 **Class Title:** 1 ### Measure #### Measurement **Group ID:** BG000 **Value:** 15 #### Measurement **Group ID:** BG001 **Value:** 15 #### Measurement **Group ID:** BG002 **Value:** 30 **Class Title:** Papillary adenocarcinoma #### Measurement **Group ID:** BG000 **Value:** 132 #### Measurement **Group ID:** BG001 **Value:** 113 #### Measurement **Group ID:** BG002 **Value:** 245 **Class Title:** Tubular adenocarcinoma #### Measurement **Group ID:** BG000 **Value:** 20 #### Measurement **Group ID:** BG001 **Value:** 17 #### Measurement **Group ID:** BG002 **Value:** 37 **Class Title:** Well-differentiated #### Measurement **Group ID:** BG000 **Value:** 105 #### Measurement **Group ID:** BG001 **Value:** 91 #### Measurement **Group ID:** BG002 **Value:** 196 **Class Title:** Moderately-differentiated #### Measurement **Group ID:** BG000 **Value:** 7 #### Measurement **Group ID:** BG001 **Value:** 5 #### Measurement **Group ID:** BG002 **Value:** 12 **Class Title:** Unknown #### Measurement **Group ID:** BG000 **Value:** 210 #### Measurement **Group ID:** BG001 **Value:** 189 #### Measurement **Group ID:** BG002 **Value:** 399 **Class Title:** Poorly differentiated adenocarcinoma #### Measurement **Group ID:** BG000 **Value:** 75 #### Measurement **Group ID:** BG001 **Value:** 95 #### Measurement **Group ID:** BG002 **Value:** 170 **Class Title:** Signet-ring cell carcinoma #### Measurement **Group ID:** BG000 **Value:** 28 #### Measurement **Group ID:** BG001 **Value:** 32 #### Measurement **Group ID:** BG002 **Value:** 60 **Class Title:** Mucinous adenocarcinoma #### Measurement **Group ID:** BG000 **Value:** 97 #### Measurement **Group ID:** BG001 **Value:** 94 #### Measurement **Group ID:** BG002 **Value:** 191 **Class Title:** Other #### Measurement **Group ID:** BG000 **Value:** 87 #### Measurement **Group ID:** BG001 **Value:** 87 #### Measurement **Group ID:** BG002 **Value:** 174 **Class Title:** Adenocarcinoma NOS #### Measurement **Group ID:** BG000 **Value:** 7 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 9 **Class Title:** Poorly differentiated cancer #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 2 **Class Title:** Unknown/not specified #### Measurement **Group ID:** BG000 **Value:** 2 #### Measurement **Group ID:** BG001 **Value:** 4 #### Measurement **Group ID:** BG002 **Value:** 6 **Class Title:** Other types ### Measure #### Measurement **Group ID:** BG000 **Value:** 438 #### Measurement **Group ID:** BG001 **Value:** 417 #### Measurement **Group ID:** BG002 **Value:** 855 **Class Title:** Stomach #### Measurement **Group ID:** BG000 **Value:** 82 #### Measurement **Group ID:** BG001 **Value:** 88 #### Measurement **Group ID:** BG002 **Value:** 170 **Class Title:** Gastroesophageal junction #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 3 #### Measurement **Group ID:** BG002 **Value:** 4 **Class Title:** Stomach and gastroesophageal junction ### Measure #### Measurement **Group ID:** BG000 **Value:** 23 #### Measurement **Group ID:** BG001 **Value:** 20 #### Measurement **Group ID:** BG002 **Value:** 43 **Class Title:** Locally advanced #### Measurement **Group ID:** BG000 **Value:** 157 #### Measurement **Group ID:** BG001 **Value:** 161 #### Measurement **Group ID:** BG002 **Value:** 318 **Class Title:** 1 metastatic site #### Measurement **Group ID:** BG000 **Value:** 340 #### Measurement **Group ID:** BG001 **Value:** 327 #### Measurement **Group ID:** BG002 **Value:** 667 **Class Title:** >/=2 metastatic sites #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 1 **Class Title:** Not assessed ### Measure #### Measurement **Group ID:** BG000 **Value:** 499 #### Measurement **Group ID:** BG001 **Value:** 485 #### Measurement **Group ID:** BG002 **Value:** 984 **Class Title:** Measureable disease #### Measurement **Group ID:** BG000 **Value:** 21 #### Measurement **Group ID:** BG001 **Value:** 22 #### Measurement **Group ID:** BG002 **Value:** 43 **Class Title:** Non-measurable disease #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 1 **Class Title:** Nonevaluable disease #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 1 **Class Title:** No disease present **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** FULL_RANGE **Parameter Type:** MEDIAN **Title:** Age, Continuous **Unit of Measure:** Years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** NUMBER **Title:** Body surface area (BSA) Categories **Unit of Measure:** Participants ### Measure 5 **Description:** 0=Fully active, able to carry on all pre-disease performance without restriction 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work **Parameter Type:** NUMBER **Title:** Eastern Cooperative Oncology Group (ECOG) Performance Status **Unit of Measure:** Participants ### Measure 6 **Description:** Patients can have more than one tissue type and are included under each type. **Parameter Type:** NUMBER **Title:** Tissue Type **Unit of Measure:** Participants ### Measure 7 **Parameter Type:** NUMBER **Title:** Anatomical Location of Primary Lesion **Unit of Measure:** Participants ### Measure 8 **Parameter Type:** NUMBER **Title:** Extent of Disease **Unit of Measure:** Participants ### Measure 9 **Parameter Type:** NUMBER **Title:** Disease Measurability **Unit of Measure:** Participants ## Results Section - More Information Module ### Certain Agreement **Other Details:** Taiho agreements vary with individual investigators, but do not prohibit any from publishing. Taiho is provided time to review material discussing trial results (generally 30 to 120 days with possible extension), and can remove undisclosed confidential, proprietary and intellectual property rights-related information. Authors have final control and approval of publication content of final study results. The investigator agrees not to publish any results before the first multicenter publication. **Restriction Type:** OTHER **Restrictive Agreement:** True ### Point of Contact **Email:** [email protected] **Organization:** Taiho Pharma USA, Inc. **Phone:** 609-750-5300 **Title:** Fabio Benedetti, MD, Chief Medical Officer ## Results Section - Outcome Measures Module ### Outcome Measure 1 #### Analysis **CI Lower Limit:** **CI Number of Sides:** **CI Percentage Value:** 95 **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY **Other Analysis Description:** **P-Value:** 0.3952 **P-Value Comment:** **Parameter Type:** **Parameter Value:** **Statistical Comment:** **Statistical Method:** Fisher Exact **Tested Non-Inferiority:** ### Outcome Measure 2 #### Analysis **CI Lower Limit:** 0.57 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.03 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY **Other Analysis Description:** **P-Value:** 0.0808 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.77 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** ### Outcome Measure 3 #### Analysis **CI Lower Limit:** 0.86 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.14 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY **Other Analysis Description:** **P-Value:** 0.9158 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.99 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** ### Outcome Measure 4 #### Analysis **CI Lower Limit:** 0.77 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 0.99 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY **Other Analysis Description:** **P-Value:** 0.0320 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.87 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** ### Outcome Measure 5 #### Analysis **CI Lower Limit:** 0.80 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 1.05 **CI Upper Limit Comment:** **Dispersion Type:** **Dispersion Value:** **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** **Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY **Other Analysis Description:** **P-Value:** 0.1983 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 0.92 **Statistical Comment:** **Statistical Method:** Log Rank **Tested Non-Inferiority:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 24.7 - **Spread:** - **Upper Limit:** 33.8 - **Value:** 29.1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 27.3 - **Spread:** - **Upper Limit:** 36.9 - **Value:** 31.9 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 5.8 - **Spread:** - **Upper Limit:** 7.4 - **Value:** 6.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 5.5 - **Spread:** - **Upper Limit:** 6.1 - **Value:** 5.8 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 4.0 - **Spread:** - **Upper Limit:** 5.5 - **Value:** 4.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 4.4 - **Spread:** - **Upper Limit:** 5.8 - **Value:** 5.5 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 3.7 - **Spread:** - **Upper Limit:** 4.0 - **Value:** 3.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 3.7 - **Spread:** - **Upper Limit:** 4.4 - **Value:** 3.8 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 7.9 - **Spread:** - **Upper Limit:** 9.5 - **Value:** 8.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 7.2 - **Spread:** - **Upper Limit:** 8.5 - **Value:** 7.9 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** The proportion of patients with objective evidence of complete response (CR) or partial response (PR) based on tumor response assessments. Per the Response Evaluation Criteria in Solid tumors (RECIST), CR was defined as the disappearance of all target lesions for at least 4 weeks, and PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** Data cutoff was 07 March 2008 (12 months after last patient randomized). **Title:** Overall Response Rate (ORR) **Type:** SECONDARY **Unit of Measure:** Percentage of patients in each group ##### Group **Description:** In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1. Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment. **ID:** OG000 **Title:** S-1/Cisplatin ##### Group **Description:** In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles. **ID:** OG001 **Title:** 5-FU/Cisplatin #### Outcome Measure 2 **Description:** Duration of response was defined as the time from date of first confirmed response (CR or PR) to date of first progressive disease (PD) or death. Per the RECIST criteria, definitions were as follows: CR was the disappearance of all target lesions for at least 4 weeks, PR was at least a 30% decrease in the sum of the longest diameter of target lesions, and PD was at least a 20% increase in the sum of the longest diameter of target lesions. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** Data cutoff was 07 March 2008 (12 months after last patient was randomized). **Title:** Duration of Response (DR) **Type:** SECONDARY **Unit of Measure:** Months ##### Group **Description:** In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1. Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment. **ID:** OG000 **Title:** S-1/Cisplatin ##### Group **Description:** In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles. **ID:** OG001 **Title:** 5-FU/Cisplatin #### Outcome Measure 3 **Description:** The time from randomization to date of first documented PD or date of death, whichever occurred first. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** From date of randomization until date of first documented PD, date of death, or until data cutoff on 07 March 2008 (12 months after last patient randomized), whichever came first. **Title:** Progression-free Survival (PFS) **Type:** SECONDARY **Unit of Measure:** Months ##### Group **Description:** In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1. Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment. **ID:** OG000 **Title:** S-1/Cisplatin ##### Group **Description:** In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles. **ID:** OG001 **Title:** 5-FU/Cisplatin #### Outcome Measure 4 **Description:** The time from randomization to date of permanent discontinuation of S-1 or 5-FU, first documented PD, or death, whichever occurred first. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** From date of randomization until date of permanent discontinuation of S-1 or 5-FU, first documented PD, death, or data cutoff on 07 March 2008 (12 months after last patient randomized), whichever came first. **Title:** Time to Treatment Failure (TTF) **Type:** SECONDARY **Unit of Measure:** Months ##### Group **Description:** In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1. Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment. **ID:** OG000 **Title:** S-1/Cisplatin ##### Group **Description:** In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles. **ID:** OG001 **Title:** 5-FU/Cisplatin #### Outcome Measure 5 **Description:** Survival was defined as the time from the date of randomization to the time of death (from any cause) for each patient. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** The cutoff date for survival analysis was 07 March 2008 (12 months after last patient randomized). **Title:** Median Survival **Type:** PRIMARY **Unit of Measure:** Months ##### Group **Description:** In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1. Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment. **ID:** OG000 **Title:** S-1/Cisplatin ##### Group **Description:** In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles. **ID:** OG001 **Title:** 5-FU/Cisplatin ### Participant Flow Module #### Group **Description:** In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1. Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment. **ID:** FG000 **Title:** S-1/Cisplatin #### Group **Description:** In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles. **ID:** FG001 **Title:** 5-FU/Cisplatin #### Period **Title:** Overall Study ##### Withdraw **Type:** Adverse Event ###### Reason **Group ID:** FG000 **Number of Subjects:** 2 ###### Reason **Group ID:** FG001 **Number of Subjects:** 2 ##### Withdraw **Type:** Death ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 2 ##### Withdraw **Type:** Withdrew Consent ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 5 ##### Withdraw **Type:** Disease progression ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 1 ##### Withdraw **Type:** Intercurrent illness ###### Reason **Group ID:** FG000 **Number of Subjects:** 0 ###### Reason **Group ID:** FG001 **Number of Subjects:** 1 ##### Withdraw **Type:** Investigator judgment ###### Reason **Group ID:** FG000 **Number of Subjects:** 0 ###### Reason **Group ID:** FG001 **Number of Subjects:** 1 ##### Withdraw **Type:** Randomization error/patient ineligible ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ###### Reason **Group ID:** FG001 **Number of Subjects:** 6 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 527 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 526 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 521 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 508 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 6 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 18 **Recruitment Details:** This multicenter study was conducted between May 18, 2005 and March 7, 2008 in 24 countries including the United States. Study centers were also located in Canada, Eastern and Western Europe, South America, Australia, and ex-Soviet Union block of nations. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT01271179 **Brief Title:** Study of Sequential Perfusion of Liver Grafts to Prevent Nonanastomotic Biliary Strictures After Liver Transplantation **Official Title:** Study of Sequential Perfusion of Liver Grafts With Low-viscosity and High-viscosity Preservation Solutions to Decrease the Incidence of Nonanastomotic Biliary Strictures After Liver Transplantation #### Organization Study ID Info **ID:** SFPH04618 #### Organization **Class:** OTHER **Full Name:** Shanghai Jiao Tong University School of Medicine ### Status Module #### Completion Date **Date:** 2010-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2011-01-06 **Type:** ESTIMATED **Last Update Submit Date:** 2011-01-05 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2010-12 **Type:** ACTUAL #### Start Date **Date:** 2004-07 **Status Verified Date:** 2010-12 #### Study First Post Date **Date:** 2011-01-06 **Type:** ESTIMATED **Study First Submit Date:** 2010-12-30 **Study First Submit QC Date:** 2011-01-05 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Shanghai Jiao Tong University School of Medicine #### Responsible Party **Old Name Title:** Zhi-Hai Peng/ vice-president of Shanghai First People's Hospital **Old Organization:** Shanghai First People's Hospital ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The study was designed to investigate whether, compared with conventional sole perfusion with high-viscosity solution of University of Wisconsin (UW), sequential perfusion of liver grafts with low-viscosity and high-viscosity preservation solutions could further decrease the incidence of nonanastomotic biliary strictures (NAS) after liver transplantation. **Detailed Description:** The exact etiology of nonanastomotic biliary strictures (NAS) with a patent hepatic artery after liver transplantation remains unclear so far. Microangiopathy is strongly suspected to be involved in the etiology, so sufficient flushing of peribiliary plexus (PBP) which directly nourishes the donor biliary tree may be pivotal to prevent NAS with a patent hepatic artery. Solution of University of Wisconsin (UW solution) is a standard for liver graft flushing, but accused of high viscosity and hyperaggregation effect on erythrocytes by ingredient hydroxyethyl starch as well as initial vasoconstriction by high potassium content, which together constitutes a hindrance to solution penetration and thorough flushing of liver microcirculation including PBP. Several studies have revealed the relationship of high viscosity of UW solution with the development of NAS. The investigators, therefore, have hypothesized that sequential perfusion with low-viscosity and high-viscosity preservation solutions might improve the patency of PBP in contrast with conventional sole perfusion with high-viscosity UW solution, and as a result, the incidence of NAS with a patent hepatic artery after liver transplantation would be significantly decreased. ### Conditions Module **Conditions:** - Liver Transplantation - Transplant Recipient **Keywords:** - orthotopic liver transplantation - preservation solution - peribiliary plexus - nonanastomotic biliary strictures - primary non-function ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 141 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** sequential perfusion of liver grafts with low-viscosity improved Ross solution and high-viscosity UW solution. **Intervention Names:** - Procedure: sequential perfusion with ipv Ross solution and UW solution **Label:** sequential perfusion **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** sole perfusion of liver grafts with high-viscosity UW solution only **Intervention Names:** - Procedure: sole perfusion with UW solution **Label:** sole perfusion **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - sequential perfusion **Description:** Totally 6 L of ipv Ross solution were initially infused (aortic: portal=1:1), followed by 2 L of cold UW solution infusion (aortic: portal=1:1). **Name:** sequential perfusion with ipv Ross solution and UW solution **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - sole perfusion **Description:** Totally 6 L of cold UW solution were infused (aortic: portal =1:1) **Name:** sole perfusion with UW solution **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** PNF is defined as non-life-sustaining function of the graft unexplained by vascular complications or rejection, leading to death or retransplantation within postoperative 7 days. **Measure:** Number of participants with primary non-function (PNF) for safety assessment of sequential perfusion **Time Frame:** 1 week **Description:** nonanastomotic biliary strictures secondary to hepatic arterial thrombosis or stenosis will be excluded from calculation. **Measure:** Number of participants with nonanastomotic biliary strictures with a patent hepatic artery **Time Frame:** 5 years #### Secondary Outcomes **Description:** IPF is defined as a delayed function restoration with serum AST level greater than 2,000 U/L and prothrombin time greater than 16 seconds postoperative days 2 to 7. **Measure:** Number of participants with initial poor function (IPF) **Time Frame:** 1 week ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * age≥18 years * ability to provide written informed consent prior to study entry * receiving a whole liver graft * primary transplantation Exclusion Criteria: * participant in other clinical trials * fulminant liver failure as the cause of transplantation * primary biliary cirrhosis, autoimmune hepatitis or primary sclerosing cholangitis as primary liver disease * retransplantation * non-liver organ(s) failure prior to study entry * donor/recipient ABO-blood-group-incompatibility **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Shanghai **Country:** China **Facility:** Shanghai First People's Hospital **State:** Shanghai **Zip:** 200080 #### Overall Officials **Official 1:** **Affiliation:** Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine **Name:** Zhi-Hai Peng, Prof. **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Moench C, Moench K, Lohse AW, Thies J, Otto G. Prevention of ischemic-type biliary lesions by arterial back-table pressure perfusion. Liver Transpl. 2003 Mar;9(3):285-9. doi: 10.1053/jlts.2003.50015. **PMID:** 12619026 **Citation:** Pirenne J, Van Gelder F, Coosemans W, Aerts R, Gunson B, Koshiba T, Fourneau I, Mirza D, Van Steenbergen W, Fevery J, Nevens F, McMaster P. Type of donor aortic preservation solution and not cold ischemia time is a major determinant of biliary strictures after liver transplantation. Liver Transpl. 2001 Jun;7(6):540-5. doi: 10.1053/jlts.2001.24641. **PMID:** 11443584 **Citation:** Sanchez-Urdazpal L, Gores GJ, Ward EM, Maus TP, Buckel EG, Steers JL, Wiesner RH, Krom RA. Diagnostic features and clinical outcome of ischemic-type biliary complications after liver transplantation. Hepatology. 1993 Apr;17(4):605-9. doi: 10.1002/hep.1840170413. **PMID:** 8477965 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020763 - Term: Pathological Conditions, Anatomical ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6475 - Name: Constriction, Pathologic - Relevance: HIGH - As Found: Stricture - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003251 - Term: Constriction, Pathologic ### Intervention Browse Module - Ancestors - ID: D000000700 - Term: Analgesics - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000889 - Term: Anti-Arrhythmia Agents - ID: D000014665 - Term: Vasodilator Agents - ID: D000058906 - Term: Purinergic P1 Receptor Agonists - ID: D000058913 - Term: Purinergic Agonists - ID: D000058905 - Term: Purinergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000963 - Term: Antimetabolites - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000006074 - Term: Gout Suppressants - ID: D000018501 - Term: Antirheumatic Agents - ID: D000016166 - Term: Free Radical Scavengers - ID: D000000975 - Term: Antioxidants - ID: D000020011 - Term: Protective Agents - ID: D000007004 - Term: Hypoglycemic Agents ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Hemat - Name: Hematinics - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: VaDiAg - Name: Vasodilator Agents - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: HIGH - As Found: Procedure - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown - ID: M10365 - Name: Insulin - Relevance: HIGH - As Found: Juvenile-onset - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: LOW - As Found: Unknown - ID: M3834 - Name: Allopurinol - Relevance: HIGH - As Found: Juvenile-onset - ID: M3595 - Name: Adenosine - Relevance: HIGH - As Found: Juvenile-onset - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M4213 - Name: Anti-Arrhythmia Agents - Relevance: LOW - As Found: Unknown - ID: M17412 - Name: Vasodilator Agents - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: M4292 - Name: Antioxidants - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000007328 - Term: Insulin - ID: D000000493 - Term: Allopurinol - ID: D000000241 - Term: Adenosine - ID: D000019999 - Term: Pharmaceutical Solutions ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01731379 **Acronym:** NerveSpect **Brief Title:** Optical Detection of Peripheral Nerve Bundles During Surgery **Official Title:** In Vivo Identification of Peripheral Nerve Bundles During Surgery Using Optical Spectroscopy Techniques - a Pilot Study #### Organization Study ID Info **ID:** NL 40893.031.12 #### Organization **Class:** INDUSTRY **Full Name:** Philips Healthcare ### Status Module #### Completion Date **Date:** 2015-10 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2015-11-03 **Type:** ESTIMATED **Last Update Submit Date:** 2015-11-02 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2014-01 **Type:** ACTUAL #### Start Date **Date:** 2012-12 **Status Verified Date:** 2015-11 #### Study First Post Date **Date:** 2012-11-21 **Type:** ESTIMATED **Study First Submit Date:** 2012-11-16 **Study First Submit QC Date:** 2012-11-16 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Philips Electronics Nederland B.V. acting through Philips CTO organization #### Lead Sponsor **Class:** INDUSTRY **Name:** Philips Healthcare #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** Investigation of application possibilities of optical spectroscopy within the field of surgical resection procedures to spare nerve tissue. Optical spectroscopy enables the possibility to specifically differentiate between different (human) tissues. The hypothesis is that incorporation of this technique into existing medical devices (e.g. medical blade) would enlarge the accuracy and reliability of these devices. Sparing of nerve bundles during surgery can lead to decreased postoperative morbidity rates. **Detailed Description:** The aim of this pilot study is to prove that an investigational optical spectroscopy system can provide accurate identification of nerve tissue during surgery. Primary Objective: The goal of this pilot study is to evaluate whether optical spectroscopy is able to differentiate between nerve tissue and surrounding tissue. Secondary Objective: During the measurement procedure, possible improvements of the measurement hardware will be recorded and the handling of the optical spectroscopy system during surgery will be evaluated. ### Conditions Module **Conditions:** - Malignant Lymphoma of Lymph Nodes of Inguinal Region - Malignant Lymphoma of Lymph Nodes of Axillary - Malignant Lymphoma of Lymph Nodes of the Cervix - Carcinoma of Parotid Gland - Colon Rectal Cancer Tubulovillous Adenocarcinoma - Tumor of Soft Tissue of Head, Face and Neck **Keywords:** - spectroscopy - nerve - muscle - fat ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 35 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients planned for elective inguinal, axillary or cervical lymph node dissection or parotidectomy, patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour. **Intervention Names:** - Procedure: Surgical resection **Label:** Surgical resections ### Interventions #### Intervention 1 **Arm Group Labels:** - Surgical resections **Description:** Patients planned for elective inguinal, axillary or cervical lymph node dissection or parotidectomy , patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour. **Name:** Surgical resection **Other Names:** - lymph node dissection - resection of parotid gland - rectal surgery - soft tumor resection **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Statistical analysis of the difference between diffuse reflectance spectra obtained at nerve tissue and its surrounding tissue measurement locations **Measure:** Differentiation between nerve tissue and its surrounding tissue **Time Frame:** Day 0 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients planned for elective inguinal, axillary or cervical lymph node dissection or parotidectomy , patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour. * Patients that have provided a signed informed consent * Patients ≥ 18 years old Exclusion Criteria: • Patients with suspected sensitivity to light; e.g. patients who have had photodynamic therapy **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Eligible patients are patients of the Netherlands Cancer Institute (NKI-AvL), who are scheduled for an elective inguinal, axillary or cervical lymph node dissection, or parotidectomy as well as patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour. ### Contacts Locations Module #### Locations **Location 1:** **City:** Amsterdam **Country:** Netherlands **Facility:** Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis **State:** Noord-Holland **Zip:** 1066 CX #### Overall Officials **Official 1:** **Affiliation:** Nederlands Kanker Instituut/Antonie van leeuwenhoek Ziekenhuis **Name:** Theo Ruers, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000008206 - Term: Lymphatic Diseases - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases - ID: D000009371 - Term: Neoplasms by Site ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M11220 - Name: Lymphoma - Relevance: HIGH - As Found: Malignant Lymphoma - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M15785 - Name: Soft Tissue Neoplasms - Relevance: HIGH - As Found: Tumor of Soft Tissue - ID: M21089 - Name: Facies - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T3543 - Name: Lymphosarcoma - Relevance: HIGH - As Found: Malignant Lymphoma ### Condition Browse Module - Meshes - ID: D000008223 - Term: Lymphoma - ID: D000012983 - Term: Soft Tissue Neoplasms ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04948879 **Brief Title:** The Role of Vascular Reconstruction in the Setting of Pelvic Exenteration **Official Title:** A Review of Surgical Outcomes for Patients Undergoing En-bloc Vascular Resection and Reconstruction as Part of Exenteration for Advanced Pelvic Malignancy #### Organization Study ID Info **ID:** PelvEx 6 #### Organization **Class:** OTHER **Full Name:** St Vincent's University Hospital, Ireland ### Status Module #### Completion Date **Date:** 2022-01-01 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** NOT_YET_RECRUITING #### Last Update Post Date **Date:** 2021-07-21 **Type:** ACTUAL **Last Update Submit Date:** 2021-07-20 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2021-11-01 **Type:** ESTIMATED #### Start Date **Date:** 2021-08-01 **Type:** ESTIMATED **Status Verified Date:** 2021-07 #### Study First Post Date **Date:** 2021-07-02 **Type:** ACTUAL **Study First Submit Date:** 2021-06-24 **Study First Submit QC Date:** 2021-06-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** St Vincent's University Hospital, Ireland #### Responsible Party **Investigator Affiliation:** St Vincent's University Hospital, Ireland **Investigator Full Name:** Professor Des Winter **Investigator Title:** Professor Des C Winter **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Local invasion or abutment of a major vascular structure was once a major deterrent to planned oncological resection. Improvements in radiological assessment and vascular surgical techniques have enabled resection of major blood vessels where focally involved. However, most of this has been conducted in the context of cancers of sarcomatous, hepaticopancreaticobilary or otolaryngological origin, with little evidence detailing the experience in the context of pelvic malignancy. The aim of this retrospective review is to examine the indications for, techniques used and surgical outcomes of vascular reconstruction in the setting of pelvic exenterative surgery. **Detailed Description:** The role of pelvic exenteration in the management of locally advanced and recurrent pelvic malignancies is ever evolving, with technical advancements enabling surgeons to perform more radical resections, offering a potential cure to many patients who would have once been deemed inoperable. As surgical oncology has shifted towards higher-volume, specialist centres in a bid to improve outcomes, surgeons have used greater experience to re-evaluate what can be considered as resectable disease. This is best exemplified by a trend towards en bloc vascular excision and reconstruction where tumours abut or focally invade adjacent vasculature. Whereas involvement of a major vascular structure remains a relative contraindication to surgery in some units (1), certain specialist centres around the world are increasingly reporting on the feasibility of this approach. It is accepted that achieving an R0 resection is the most significant prognostic factor for overall survival (OS) in exenterative surgery. Conversely, involvement of the lateral compartment is a poor prognostic variable, in large part due to the difficulty obtaining a negative resection margin without compromising neurovascular structures(2). Improvements in pre-operative radiological assessment, particularly with respect to angiography, have facilitated appropriate patient and treatment selection, while advancements in the field of vascular surgery have made the procedure technically feasible. However, there is no clear consensus on the role of vascular reconstruction in curative treatment of advanced pelvic malignancy, owing to a paucity of published data. Initial reports and series have shown promising results, but these are almost exclusively single-surgeon experiences with small numbers and heterogenous populations. Therefore, there is a need for collaborative data to assess the impact and success of such surgical strategies. The aim of this retrospective review is to examine the indications for, techniques used and surgical outcomes of vascular reconstruction in the setting of pelvic exenterative surgery at a multicentre level in order to inform future practice, with a particular focus on whether or not it significantly increases the morbidity in the short-term. ### Conditions Module **Conditions:** - Vascular Reconstruction in Pelvic Exenterative Surgery ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients who have undergone resection with or without reconstruction of a major blood vessel in the context of surgery for a locally advanced pelvic malignancy. This will mostly refer to patients who have had resection/reconstruction of their internal iliac vessels, or less likely common iliacs. **Intervention Names:** - Procedure: Vascular resection/reconstruction **Label:** Vascular reconstruction ### Interventions #### Intervention 1 **Arm Group Labels:** - Vascular reconstruction **Description:** The resection of a major blood vessel with or without reconstruction **Name:** Vascular resection/reconstruction **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Post-operative complications (\<30 days), as measured by the Clavien-Dindo scale **Measure:** Morbidity **Time Frame:** July 2016 - July 2021 #### Secondary Outcomes **Description:** Blood loss (mL) **Measure:** Blood loss **Time Frame:** July 2016 - July 2021 **Description:** Duration of stay in hospital post-procedure **Measure:** Length of stay **Time Frame:** July 2016 - July 2021 **Description:** Whether or not the reconstruction is functioning **Measure:** Graft patency/function **Time Frame:** July 2016 - July 2021 **Description:** Resection margins (R0, R1 or R2) **Measure:** Resection status **Time Frame:** July 2016 - July 2021 **Description:** Proportion of patients who die within 30 days of the procedure **Measure:** Mortality **Time Frame:** July 2016 - July 2021 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Histologically proven locally advanced or recurrent pelvic cancer (all subtypes, RECTAL, UROLOGICAL, GYNAE, SARCOMA) * Aged over 18 years * Undergoing a multi-visceral extended pelvic resection * Requiring a vascular resection with or without the need for reconstruction as part of pelvic exenteration Exclusion Criteria: * Strong evidence of metastatic or peritoneal disease * No histological evidence of vascular structures resected at time of operation * Insufficient patient follow-up (Minimum of 30 days) * Insufficient information on post-operative follow-up of graft patency/function **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients over the age of 18 years who undergo resection/reconstruction of a major blood vessel as part of pelvic exenteration for a locally advanced or recurrent pelvic (rectal, urological, gynaecological, sarcomatous) malignancy. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Matthew Fahy, MB **Phone:** 00353874510237 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Michael Kelly, MD **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** St. Vincent's Healthcare Group **Name:** Desmond Winter, MD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Description:** Patient data will be anonymised by participating PelvEx centres and then shared with the collaborative. **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00198679 **Brief Title:** Effect of Chlorhexidine Skin Cleansing on Skin Flora **Official Title:** Effect of Chlorhexidine Skin Cleansing on Skin Flora of Newborn Infants in Bangladesh #### Organization Study ID Info **ID:** H.22.03.10.07.A2 #### Organization **Class:** OTHER **Full Name:** Johns Hopkins Bloomberg School of Public Health ### Status Module #### Completion Date **Date:** 2005-03 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-04-20 **Type:** ACTUAL **Last Update Submit Date:** 2018-04-18 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2005-03 **Type:** ACTUAL #### Start Date **Date:** 2004-03 **Status Verified Date:** 2006-05 #### Study First Post Date **Date:** 2005-09-20 **Type:** ESTIMATED **Study First Submit Date:** 2005-09-12 **Study First Submit QC Date:** 2005-09-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Johns Hopkins Bloomberg School of Public Health ### Description Module **Brief Summary:** Given the potential of skin cleansing with chlorhexidine as a safe, feasible, and cost-effective intervention for reducing neonatal death in developing country settings, this study follows a trial already underway in Nepal to test the impact of a single cleansing of the skin with baby wipes cotaining chlorahexidine. **Detailed Description:** This study is designed to test the impact of a single cleansing of the skin with 0.25% or 4.0% Chlorhexidine wipes on qualitative and quantitative skin flora and skin condition in newborn infants. The study takes place in the Special Care Nursery at Dhaka Shishu Hospital in Dhaka, Bangladesh. ### Conditions Module **Conditions:** - Skin Diseases, Infectious **Keywords:** - skin cleansing - Bangladesh - Skin Flora - Newborn - infectious disease - chlorhexidine ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 210 **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** Chlorhexidine **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Wiping of newborn skin will be done immediatly upon enrollment in study, with follow up during hosptial stay and up to two weeks to determine skin condition and presence of any kind of skin infection. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Infant admitted to Special Care Nursery at Dhaka Shishu Hospital less than 48 hours chronological age * parental consent must be obtained Exclusion Criteria: * infants being admitted for major surgical procedure which is attended by high rate of infectious complications * sepsis * clinically-evident skin infection * generalized skin disease * structural defect of the skin involving greater than 5% of the body surface * with a major congenital anomaly * with a known immunodeficiency **Healthy Volunteers:** True **Maximum Age:** 48 Hours **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Dhaka **Country:** Bangladesh **Facility:** Dhaka Shishu Hospital #### Overall Officials **Official 1:** **Affiliation:** Johns Hopkins Bloomberg School of Public Health **Name:** Gary Darmstadt, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Diseases, Infectious - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Diseases, Infectious - ID: M15674 - Name: Skin Diseases - Relevance: HIGH - As Found: Skin Diseases - ID: M15677 - Name: Skin Diseases, Infectious - Relevance: HIGH - As Found: Skin Diseases, Infectious - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003141 - Term: Communicable Diseases - ID: D000007239 - Term: Infections - ID: D000012874 - Term: Skin Diseases, Infectious - ID: D000012871 - Term: Skin Diseases ### Intervention Browse Module - Ancestors - ID: D000000891 - Term: Anti-Infective Agents, Local - ID: D000000890 - Term: Anti-Infective Agents - ID: D000004202 - Term: Disinfectants ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Derm - Name: Dermatologic Agents ### Intervention Browse Module - Browse Leaves - ID: M5953 - Name: Chlorhexidine - Relevance: HIGH - As Found: Digital - ID: M344731 - Name: Chlorhexidine gluconate - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M4215 - Name: Anti-Infective Agents, Local - Relevance: LOW - As Found: Unknown - ID: M7383 - Name: Disinfectants - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000002710 - Term: Chlorhexidine ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02649179 **Brief Title:** Local Infiltration With Ropivacaine Improves Postoperative Pain Control in Patients **Official Title:** Local Infiltration With Ropivacaine Improves Postoperative Pain Control in Patients Undergoing Laparoscopic Cholecystectomy: a Prospective, Randomized, Placebo Controlled, Double-blind Trial #### Organization Study ID Info **ID:** XJH-A-ESR-14-10228 #### Organization **Class:** OTHER **Full Name:** Air Force Military Medical University, China ### Status Module #### Completion Date **Date:** 2017-09 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-07-26 **Type:** ACTUAL **Last Update Submit Date:** 2018-07-25 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-06 **Type:** ACTUAL #### Start Date **Date:** 2016-08 **Type:** ACTUAL **Status Verified Date:** 2018-07 #### Study First Post Date **Date:** 2016-01-07 **Type:** ESTIMATED **Study First Submit Date:** 2016-01-06 **Study First Submit QC Date:** 2016-01-06 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Air Force Military Medical University, China #### Responsible Party **Investigator Affiliation:** Air Force Military Medical University, China **Investigator Full Name:** Zhihong LU **Investigator Title:** Doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to evaluate the effect of pain relief after infusion of ropivacaine at port sites at end of laparoscopic cholecystectomy (LC)compared with placebo (0.9% normal saline). **Detailed Description:** Patients were randomly assigned to two groups, On Day 1,each subject was to undergo laparoscopic cholecystectomy under general anesthesia. Anesthesia will be induced with fentanly (2-4ug/kg), propofol TCI (4ug/ml), rocuronium (0.6mg/kg), and maintaine with remifentanly(0.1-0.3ug/kg.h) , and propofol TCI (3-5ug/ml). At the end of the operation before wound closure, patients were randomized 1:1 to receive ropivacaine or placebo. In study group all wounds were infiltrated with 0.75% ropivacaine 14ml at port sites before wound closure(6ml for epigastric port ,6ml for umbilical port ,and 4ml for working port) . The study drugs will be applied to the skin, subcutis, fascia, and parietal peritoneum through the port sites at the end of surgery. All anesthetics will be stopped when wound infiltration completed. Patients will be send to PACU for monitor a while then back to ward. Record of pain intensity evaluation and rescue analgesic medication consumption were to continue through 48hours after administration of study drug. Pain intensity will be assessed by using a 0-10 point VAS scale. VAS-rest and VAS-coughing were recorded at the baseline ,2,4,6,8,12,18,24,48 hours. Postoperative Rescue analgesia consisit of Parecoxib Sodium 40mg be given by a nurse on requst of the subject to a maximum of 80mg per day. ### Conditions Module **Conditions:** - Postoperative Pain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 140 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** patients were to receive 0.75% ropivacaine **Intervention Names:** - Drug: Ropivacaine **Label:** local infiltration with ropivacaine **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** patients were to receive placebo **Intervention Names:** - Drug: 0.9% saline **Label:** local infiltration with 0.9% saline **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - local infiltration with ropivacaine **Description:** All wounds were infiltrated with 0.75% ropivacaine 14ml at port sites before wound closure(6ml for epigastric port ,6ml for umbilical port ,and 4ml for working port) . The study drugs will be applied to the skin, subcutis, fascia, and parietal peritoneum through the port sites at the end of surgery. **Name:** Ropivacaine **Other Names:** - Naropin **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - local infiltration with 0.9% saline **Description:** All wounds were infiltrated with 0.9% saline 14ml at port sites before wound closure(6ml for epigastric port ,6ml for umbilical port ,and 4ml for working port) . The study drugs will be applied to the skin, subcutis, fascia, and parietal peritoneum through the port sites at the end of surgery. **Name:** 0.9% saline **Other Names:** - saline **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** The area under the curve of visual analog scale (VAS) pain intensity scores at rest through 24h postoperative **Time Frame:** 0-24h postoperative ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Female or male, and any race, Age≥18 years at the screening visite. * ASA physical status I to II. * Scheduled to undergo laparoscopic cholecystectomy under general anesthesia. * Famale subjects must be without pregnancy. * Ability to provide informed consent, adhere to the study visite schedule, and complete all study assessments. Exclusion Criteria: * Boss mass index \>35kg/㎡ * Under intravertebral anesthesia and/or epidural analgesia * Under postoperatived patient-controlled epidural analgesia (PCEA) and postoperative intravenous analgesia(PCIA). * Inability to understand and use the visual analog scale (VAS) * Currently pregnant,nursing,or planning to become pregnant during the study or within one month after study drug administration. * Chronic user of analgesic medications, including taking opioid medications for more than 14 days in the last 3months,or non-opioid pain medications more than 5 times per week. * Proven or suspected allergy to local anesthetics ,NSAIDs and opioids . * Use of any NSAIDs including selective COX-2 inhibitor , opioids or other analgesic agents within 3days of surgery. * History of suspected or known addiction to or abuse of drugs or alcohol within the past 2 years. * Current acute or chronic medical or major psychiatric disease that,in the opinion of the investigator ,would interfere with the evaluation of study drug efficacy or safety. * Any other subjects were not suitable to this study in the opinion of the investigator. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Xi'an **Country:** China **Facility:** Xijing Hospital, Fourth Military Medical University **State:** Shaanxi **Zip:** 710032 #### Overall Officials **Official 1:** **Affiliation:** Air Force Military Medical University, China **Name:** Zhihong Lu, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M13069 - Name: Pain, Postoperative - Relevance: HIGH - As Found: Postoperative Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010149 - Term: Pain, Postoperative ### Intervention Browse Module - Ancestors - ID: D000000779 - Term: Anesthetics, Local - ID: D000000777 - Term: Anesthetics - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1700 - Name: Ropivacaine - Relevance: HIGH - As Found: Eye - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077212 - Term: Ropivacaine ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04396379 **Acronym:** ENRAPTUS **Brief Title:** Epicardial Mitral Touch System for Mitral Insufficiency **Official Title:** ENRAPTUS Epicardial Mitral Touch System for Mitral Insufficiency #### Organization Study ID Info **ID:** TPL0002 #### Organization **Class:** INDUSTRY **Full Name:** Mitre Medical Corp. ### Status Module #### Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-01-04 **Type:** ACTUAL **Last Update Submit Date:** 2023-01-02 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Start Date **Date:** 2023-09-10 **Type:** ESTIMATED **Status Verified Date:** 2023-01 #### Study First Post Date **Date:** 2020-05-20 **Type:** ACTUAL **Study First Submit Date:** 2020-05-15 **Study First Submit QC Date:** 2020-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** BSWRI Cardiac Imaging Core Lab (CICL) #### Lead Sponsor **Class:** INDUSTRY **Name:** Mitre Medical Corp. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is Unapproved Device:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** To evaluate the safety and performance of the Mitral Touch System to treat mitral insufficiency in patients who are to undergo cardiac surgery with either a sternotomy or thoracotomy who present with moderate to severe ischemic or functional mitral regurgitation. **Detailed Description:** The Mitral Touch Systems is intended to epicardially reshape the mitral valve annulus and left ventricle without the need for cardiopulmonary bypass (CPB) and open-heart access (atriotomy), in patients with left ventricular dilation and mitral valve insufficiency in patients with ischemic or functional MR. ### Conditions Module **Conditions:** - Ischemic Mitral Regurgitation - Functional Mitral Regurgitation ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** prospective, single arm, un-blinded, multi-center early feasibility study ##### Masking Info **Masking:** NONE **Primary Purpose:** DEVICE_FEASIBILITY #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** To epicardially reshape the mitral valve annulus and left ventricle without the need for cardiopulmonary bypass (CPB) and open-heart access (atriotomy) using an epicardial implant. **Intervention Names:** - Device: Implant an epicardial device to reshape the mitral valve annulus **Label:** Device Implantation **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Device Implantation **Description:** The implant is intended to epicardially reshape the mitral valve annulus and left ventricle without the need for cardiopulmonary bypass (CPB) and open-heart access (atriotomy), in patients with left ventricular dilation and mitral valve insufficiency in patients with ischemic or functional MR. **Name:** Implant an epicardial device to reshape the mitral valve annulus **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Freedom from Major Adverse Events such as death, stroke, Increase of NYHA \>1, Re-Hospitalization or reoperation of the Mitral Valve **Measure:** Rate of Freedom from Major Adverse Events **Time Frame:** Procedure through 30 days #### Secondary Outcomes **Description:** Septal lateral diameter reduction of the mitral valve at implantation, Reduction in MR Grade by at least 1 grade from baseline **Measure:** Rate of Technical Feasibility to implant the Mitral Touch Device **Time Frame:** Procedure **Description:** Implantation of the Mitral Touch Device without Serious Adverse Events **Measure:** Rate of Freedom from Serious Adverse Events from Implantation of the Mitral Touch Device **Time Frame:** procedure ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Moderate or greater (2+) ischemic * Functional Mitral regurgitation by 2D echocardiography using an integrative method * Patient is scheduled for cardiac surgery (e.g. CABG including patients on the waiting list for Heart Transplantation) * Patient is 22 years of age or older * Patient is willing and able to sign Informed Consent Form * Within 90 days patients should be on stable optimally uptitrated medical therapy recommended according to current guidelines23 as standard of care for heart failure therapy in the United States Exclusion Criteria: * Any evidence of structural (chordal or leaflet) mitral valve disease * Inability to derive ERO, LVESVI or LVEDVI by TTE * Prior surgical or percutaneous mitral valve intervention * Contraindication to cardiopulmonary bypass (CPB) * Clinical signs of cardiogenic shock * Treatment with chronic intravenous inotropic therapy * Severe, irreversible pulmonary hypertension in the judgement of the investigator * ST segment elevation requiring intervention within 7 days prior to randomization * Congenital heart disease (except PFO or ASD) * Evidence of cirrhosis or hepatic synthetic failure * Renal insufficiency (eGFR \< 30 ml/min) * History of endocarditis or current endocarditis * Ejection fraction \<25% * NY heart class IV * MV diameters \> 7cm * Any coronary artery calcification at site of placement as determined by angiogram * Myxomatous mitral regurgitation * Women who are pregnant (by history of menstrual period or pregnancy test if history is considered unreliable) * Abnormal cardiac anatomy discovered prior to surgery or during procedure * Pericardial adhesions * Insufficient clinical signature reduction of mitral regurgitation during device sizing and placement. (No device remains, patient moved to only 30-Day follow-up.) **Minimum Age:** 22 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** John MacMahon **Phone:** (408)-940-5587 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Laura A Minarsch **Phone:** (949)2805700 **Role:** CONTACT #### Locations **Location 1:** **City:** Plano **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Robert L. Smith, MD - **Phone:** 469-814-3278 - **Role:** CONTACT ***Contact 2:*** - **Name:** Robert L. Smith, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Baylor Scott and White **State:** Texas **Zip:** 75093 #### Overall Officials **Official 1:** **Affiliation:** Baylor Scott and White Medical Center **Name:** Robert L Smith II, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006349 - Term: Heart Valve Diseases - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases ### Condition Browse Module - Browse Leaves - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M11910 - Name: Mitral Valve Insufficiency - Relevance: HIGH - As Found: Mitral Regurgitation - ID: M9437 - Name: Heart Valve Diseases - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008944 - Term: Mitral Valve Insufficiency ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05298579 **Brief Title:** Yoga Exercises Applied With Two Different Technological Access **Official Title:** Comparison of the Efficiency of Yoga Exercises Applied With Two Different Technological Access in White Collar Employees #### Organization Study ID Info **ID:** BiruniA #### Organization **Class:** OTHER **Full Name:** Biruni University ### Status Module #### Completion Date **Date:** 2022-10-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-11-16 **Type:** ACTUAL **Last Update Submit Date:** 2022-11-15 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-10-15 **Type:** ACTUAL #### Start Date **Date:** 2022-04-01 **Type:** ACTUAL **Status Verified Date:** 2022-11 #### Study First Post Date **Date:** 2022-03-28 **Type:** ACTUAL **Study First Submit Date:** 2022-03-17 **Study First Submit QC Date:** 2022-03-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Biruni University #### Responsible Party **Investigator Affiliation:** Biruni University **Investigator Full Name:** Buket AKINCI **Investigator Title:** Assoc.Prof. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Yoga, a form of exercise designed to bring balance and health to the physical, mental, emotional and spiritual dimensions of the individual, will benefit many white-collar workers by using popular technological environments to increase overall physical activity and well-being. The aim of this study is to examine the effects of yoga exercises applied with two different technological access in white-collar employees on musculoskeletal pain, fatigue, sleep quality, stress level, quality of life and work efficiency. **Detailed Description:** Considering the importance of the workforce and possible health problems in white-collar workers, it seems rational to implement health promotion practices in accordance with the digital age. There is no study in the literature examining the effectiveness of technology-based yoga on selected health outcomes in white-collar workers. Based on this shortcoming, the aim of this study is to examine the effects of yoga exercises applied with two different technological access in white-collar employees on musculoskeletal pain, fatigue, sleep quality, stress level, quality of life and work efficiency. ### Conditions Module **Conditions:** - Work Related Stress - Pain - Fatigue **Keywords:** - white collar workers - yoga - remote exercise ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Masking Description:** The assessors will be blind to the group allocation. The investigators will be blind to the outcomes. **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 22 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Yoga exercises applied by video-conference method accompanied by a physiotherapist. Evaluations and yoga exercises will be applied to the participants in this group through the "Zoom program". Yoga exercises were created with reference to studies in the literature. It will be applied for 8 weeks, 3 days a week and 40-45 minutes, at a time determined jointly by the physiotherapist and the participant (Table 1). Before starting the program, an informative broadcast will be made to the participants and groups of 6-8 people will be formed. **Intervention Names:** - Other: Yoga exercises **Label:** Group A **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Yoga exercises performed asynchronously accompanied by videos. Exercise videos will be broadcast to the participants in this group through the "YouTube program". The shooting of the exercise videos will be completed in advance and uploaded to a channel opened on YouTube. All posts made in this channel will only be open to individuals participating in the research during the duration of the study. Yoga exercises were created with reference to studies in the literature. It will be applied for 8 weeks, 3 days a week and 40-45 minutes. Participants will be able to access the exercise videos at a time they want (Table 2). Participants will be encouraged to achieve weekly targeted training sessions and to keep an exercise diary. **Intervention Names:** - Other: Yoga exercises **Label:** Group B **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group A - Group B **Description:** Yoga-based exercise training includes a warm-up and cool-down period for beginners **Name:** Yoga exercises **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** International Physical Activity Questionnarie -Short Form: This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. **Measure:** physical activity level **Time Frame:** 8 weeks #### Secondary Outcomes **Description:** Nordic Musculoskeletal Questionnaire: The questionnaire consists of four parts. In the first part, first name, last name, date of questioning, gender, date of birth, body weight, length of stature, dominant side, how many years/months has he been working in the current job and how many hours worked on average in a week are recorded. In the second part the last 12 months, individuals in nine different body regions (neck, shoulder, back, elbow, waist circumference, wrist/hand, hip/thigh, knee, and ankle/foot) with the presence of pain or discomfort experienced the pain of blocking the Activity Status is questioned. The third section nine different body areas of pain or discomfort experienced in the last 7 days individuals in the presence and in the final chapter, an individual one of these areas which, when applied to the physician because of pain or discomfort in questioned. **Measure:** musculoskeletal pain level **Time Frame:** 8 weeks **Description:** The Fatigue Severity Scale: It is shown as the best example among one-dimensional decimals. It consists of a total of 9 questions, and each question on the scale is scored from 1 (I don't agree at all) to 7 (I completely agree). The total score of the scale dec from 9 to 63. The fact that the total score that can be obtained from the scale is 36 or higher indicates severe fatigue. **Measure:** fatigue severity. **Time Frame:** 8 weeks **Description:** Pittsburgh Sleep Quality Index: The scale evaluates the individual's sleep quality, amount of sleep and the presence of sleep disorder. There are 19 questions answered by the individual himself and 5 questions answered by the individual's roommate in the scale, which consists of 24 questions in total. However, when calculating the total score of the scale, the questions answered by the roommate are not included in the calculation. The scoring includes 18 items and 7 components: subjective sleep quality, sleep latency (delay), sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, daytime dysfunction. Each item is scored between 0-3. The total score of the scale is calculated by the sum of the scores from the seven components, and the total score ranges from 0 to 21 points. A total score of 5 or more indicates poor sleep quality. **Measure:** sleep quality **Time Frame:** 8 weeks **Description:** Perceived Stress Index: The Perceived Stress Scale will be used to evaluate the stress level of the participants. The scale was developed to identify the source of stress and the level of perceived stress. The questions in the scale should be answered by taking into account the feelings and thoughts in the last month. It consists of 14 items in total and each item is rated with a 5-point Likert-type scale. High scores obtained from the scale indicate that the perception of stress is high. **Measure:** perceived stress **Time Frame:** 8 weeks **Description:** Short Form-36 will be used to assess the participants' quality of life. The scale developed by Corporation consists of 36 items and 8 sub-dimensions. Sub-dimensions of the scale; physical function (10 items), social function (2 items), role limitations due to physical functions (4 items), role limitations due to emotional problems (3 items), mental health (5 items), energy/vitality (4 items), pain (2 items) and general perception of health (5 items). Each item in the scale should be answered considering the last four weeks. Instead of a single total score from the scale, each sub-dimension is scored separately. The sub-dimension score ranges from 0 to 100. 0 points indicate poor health and 100 points indicate good health. **Measure:** quality of life of the participants **Time Frame:** 8 weeks **Description:** Endicott Productivity at Work scale: The scale consists of 25 items and besides these items, the number of hours the individual has to work, the number of hours he has worked, and if he has worked less than necessary, the reason for this is questions. The 25 items related to work efficiency are never (0), rarely (1), sometimes (2), often (3), or almost always (4), depending on how often the individual's behavior, emotion, or attitude has been seen in the previous week. as a score. The lowest total score that can be obtained from the scale is 0 and the highest total score is 100. A high score indicates low work efficiency. **Measure:** work efficiency **Time Frame:** 8 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * • Working full-time in the last 1 year in administrative, research-development, high-tech education, mind and brain power-based jobs * Speaks and writes Turkish * In order to join online sessions, participants should have internet access * All answers of the Physical Activity Preparation Survey should be selected as "No" Exclusion Criteria: * • Uncontrolled hypertension and uncontrolled arrhythmia patience * Individuals who have undergone percutaneous transluminal coronary angiography or have a cardiac pacemaker * Individuals with severe neurological disease or serious respiratory disease * Previous stroke, myocardial infarction * Individuals who have undergone amputation * Individuals with major musculoskeletal problems * Individuals with injuries involving the lower extremity in the past 6 months * Pregnant or planning a pregnancy within 1 year * Breastfeeding * Use of sleeping pills or medication for psychological problems and/or shift workers **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Biruni University #### Overall Officials **Official 1:** **Affiliation:** Biruni University **Name:** Buket Akıncı **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009784 - Term: Occupational Diseases - ID: D000013315 - Term: Stress, Psychological - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC24 - Name: Occupational Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M8364 - Name: Fatigue - Relevance: LOW - As Found: Unknown - ID: M1167 - Name: Occupational Stress - Relevance: HIGH - As Found: Work Related Stress - ID: M12719 - Name: Occupational Diseases - Relevance: LOW - As Found: Unknown - ID: M16105 - Name: Stress, Psychological - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000073397 - Term: Occupational Stress ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02875379 **Brief Title:** Clinical Comparison of Different Humidification Strategies During Noninvasive Ventilation With Helmet **Official Title:** Clinical Comparison of Different Humidification Strategies During Noninvasive Ventilation With Helmet #### Organization Study ID Info **ID:** 11491/15 #### Organization **Class:** OTHER **Full Name:** Catholic University of the Sacred Heart ### Status Module #### Completion Date **Date:** 2019-01-23 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-01-24 **Type:** ACTUAL **Last Update Submit Date:** 2019-01-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-01-23 **Type:** ACTUAL #### Start Date **Date:** 2017-02-01 **Type:** ACTUAL **Status Verified Date:** 2019-01 #### Study First Post Date **Date:** 2016-08-23 **Type:** ESTIMATED **Study First Submit Date:** 2015-07-27 **Study First Submit QC Date:** 2016-08-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Catholic University of the Sacred Heart #### Responsible Party **Investigator Affiliation:** Catholic University of the Sacred Heart **Investigator Full Name:** Massimo Antonelli **Investigator Title:** M.D. Full Professor of Anesthesiology and Intensive Care. Head of the department of Anesthesiology and Intensive Care medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Background. Non invasive positive pressure ventilation (NIV) is among first line treatments of acute respiratory failure. Several interfaces are available for non-invasive ventilation.Despite full face and oronasal masks are more frequently used, some evidence suggests that helmets may optimize patients' comfort and NIV tolerability. During NIV, humidification strategies (heat and moisture exchangers HME or heated humidifiers HH) may significantly affect patient's comfort and work of breathing. Despite physiological data suggested heated humidification as the best strategy during NIV with full face masks, no differences were found in a randomized controlled study assessing the effects of HME or HH on a pragmatic clinical outcome. However, the higher dead space (i.e. 18 L/min) and rebreathing rate observed during helmet NIV make such results not applicable to this particular setting. The investigators designed a randomized-crossover trial to assess the effect of four humidification strategies during helmet NIV on patients with acute respiratory failure, in terms of comfort, work of breathing and patient-ventilator interaction. Methods. All awake, collaborative, hypoxemic patients requiring mechanical ventilation will be considered for the enrollment. Hypercapnic patients (i.e.PaCO2\>45 mmHg) will be excluded. Each enrolled patient will undergo helmet NIV with all the following humidification strategies in a random order. Each period will last 60 minutes. * Passive humidification, double tube circuit. * Heated humification (MR 730, Fisher \& Paykel, Auckland, New Zealand), humidification chamber temperature 33°C. * Heated humification (MR 730, Fisher \& Paykel, Auckland, New Zealand), humidification chamber temperature 37°C. * Passive humidification with HME, Y-piece circuit. Ventilatory settings (Draeger Evita xl or Evita infinity ventilators): Pressure support ventilation; pressure support=20 cmH20; FiO2 titrated to obtain SpO2 between 92 and 98%; positive end-expiratory pressure=10 cmH2O; maximum inspiratory time 0.9 seconds; inspiratory flow trigger = 2 l/min; expiratory trigger: 30% of the maximum inspiratory flow; pressurization time=0,00 s. Such settings will be kept unchanged during the whole study period. An oesophageal catheter will be placed and secured to measure oesophageal pressure (Pes) and gastric pressure (Pga) (Nutrivent, Italy): the reliability of the measured pressure will be confirmed with an airway occlusion test during NIV with oronasal mask. Work of breathing will be estimated with the pressure-time product (PTP) of the pleural pressure. A pneumotachograph (KleisTek) will record flow, airway pressure, Pes and Pga on a dedicated laptop. At the end of each cycle, the patient will be asked to rate his/her discomfort on a visual analog scale (VAS) modified for ICU patients. The level of dyspnea will be assessed with the Borg dyspnea scale. The following parameters will be record at the end of each cycle: Arterial pressure, heart rate, respiratory rate, SpO2, pH, PCO2, PaO2, SaO2. Airway and esophageal pressure signals will be reviewed offline to detect patient-ventilator asynchronies (ineffective efforts, double cycling, premature cycling, delayed cycling) and asynchrony index (number of asynchrony events divided by the total respiratory rate computed as the sum of the number of ventilator cycles (triggered or not) and of wasted efforts) will be computed. The trigger delay will be also measured. The pressurization and depressurization velocity will be assessed with the PTP airway index 300 and 500 (inspiratory and expiratory), as suggested by Ferrone and coworkers. The work of breathing (WOB) for each breath will be estimated by PTPes. An hygrometer (Dimar SRL, Italy) will measure and record on a dedicated laptop Helmet temperature, relative and absolute humidity. Primary endpoints: patient's comfort, work of breathing and asynchrony index. Sample Sizing: Given the physiological design of the study, the investigators did not make an a priori sample size and plan to enroll 24 patients. **Detailed Description:** Background Non invasive positive pressure ventilation (NIV) is among first line treatments of acute respiratory failure. In patients with new-onset respiratory failure, NIV was showed to reduce the rate of complications and the length of ICU stay, as compared to invasive mechanical ventilation\[1\] Several interfaces are available for non-invasive ventilation: full face masks, oronasal masks, nasal prongs and helmets\[2\]. Despite full face and oronasal masks are more frequently used, some evidence suggests that helmets may optimize patients' comfort and NIV tolerability. The helmet allows patients' interaction, speech, feeding and does not limit cough. In addition, skin necrosis, gastric distension, or eye irritation are seldom observed during helmet NIV, while may be consequences of long-term treatments with face masks. \[3\] On the contrary, helmet NIV hampers tidal volume monitoring, is contraindicated in hypercapnic patients and requires specific ventilator settings\[4\]. Lastly, when compared to face masks, helmets may increase the work of breathing and worsen patient-ventilator interaction\[5\]\[6\]\[7\]. During NIV, humidification strategies (heat and moisture exchangers HME or heated humidifiers HH) may significantly affect patient's comfort and work of breathing \[8\]\[9\]. Despite physiological data suggested heated humidification as the best strategy during NIV with full face masks\[8\]\[9\], no differences were found in a randomized controlled study assessing the effects of HME or HH on a pragmatic clinical outcome\[10\]. However, the higher dead space (i.e. 18 L/min) and rebreathing rate observed during helmet NIV make such results not applicable to this particular setting. One only study assessed the effects of a HH during helmet low-flow continuous positive airway pressure on comfort in healthy volunteers\[11\]. Indeed, patients suffering from acute respiratory failure may behave differently, especially in terms of minute ventilation and maximum inspiratory flow. A recent bench study identified a better patient-ventilator interaction when helmet NIV was provided through a double tube circuit, as compared to the Y-piece system \[12\]. The investigators designed a randomized-crossover trial to assess the effect of four humidification strategies during helmet NIV on patients with acute respiratory failure, in terms of comfort, work of breathing and patient-ventilator interaction. Methods Design: monocentric, randomized, cross-over trial. Each enrolled patient will undergo helmet NIV with all the following humidification strategies in a random order. Each period will last 60 minutes. * Passive humidification, double tube circuit. * Heated humification (MR 730, Fisher \& Paykel, Auckland, New Zealand), humidification chamber temperature 33°C. * Heated humification (MR 730, Fisher \& Paykel, Auckland, New Zealand), humidification chamber temperature 37°C. * Passive humidification with HME, Y-piece circuit. Ventilatory settings (Draeger Evita xl or Evita infinity ventilators): Pressure support ventilation; pressure support=20 cmH20\[4\]; FiO2 titrated to obtain SpO2 between 92 and 98%; positive end-expiratory pressure=10 cmH2O\[4\]; maximum inspiratory time 0.9 seconds; inspiratory flow trigger = 2 l/min; expiratory trigger: 30% of the maximum inspiratory flow; pressurization time=0,00 s. Such settings will be kept unchanged during the whole study period. An oesophageal catheter will be placed and secured to measure oesophageal pressure (Pes) and gastric pressure (Pga) (Nutrivent, Italy): the reliability of the measured pressure will be confirmed with an airway occlusion test during NIV with oronasal mask\[13\]. Work of breathing will be estimated with the pressure-time product (PTP) of the pleural pressure\[13\]. A pneumotachograph (KleisTek) will record flow, airway pressure, Pes and Pga on a dedicated laptop. At the end of each cycle, the patient will be asked to rate his/her discomfort on a visual analog scale (VAS) modified for ICU patients. The level of dyspnea will be assessed with the Borg dyspnea scale\[14\]. The following parameters will be record at the end of each cycle: Arterial pressure, heart rate, respiratory rate, SpO2, pH, PCO2, PaO2, SaO2. Airway and esophageal pressure signals will be reviewed offline to detect patient-ventilator asynchronies (ineffective efforts, double cycling, premature cycling, delayed cycling) and asynchrony index (number of asynchrony events divided by the total respiratory rate computed as the sum of the number of ventilator cycles (triggered or not) and of wasted efforts) will be computed\[15\]. The trigger delay will be also measured. The pressurization and depressurization velocity will be assessed with the PTP airway index 300 and 500 (inspiratory and expiratory), as suggested by Ferrone and coworkers\[12\]. The work of breathing (WOB) for each breath will be estimated by PTPes. An hygrometer (Dimar SRL, Italy) will measure and record on a dedicated laptop Helmet temperature, relative and absolute humidity. End point: Primary endpoints: patient's comfort, work of breathing and asynchrony index. Sample Sizing: Given the physiological design of the study, the investigators did not make an a priori sample size and planned to enroll 24 patients. Statistical analysis Qualitative data will be expressed as number of events (%) and continuous data as mean ± standard deviation or median \[Interquartile range\]. Comparisons concerning qualitative variables will be performed with the Mc-Namar test. Ordinal qualitative variables or non normal quantitative variables will be compared with the Friedman's Test, the wilcoxon sum of ranks test or the Mann-Whitney test, as appropriate. All analysis will be performed applying a bilateral hypothesis. P ≤ 0.05 will be considered significant. Statistical analysis will be performed with SPSS 20.0. ### Conditions Module **Conditions:** - Respiratory Failure **Keywords:** - Noninvasive Ventilation - Mechanical Ventilation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Passive humidification with heat and moisture exchanger, Y-piece circuit. **Intervention Names:** - Procedure: Measurements **Label:** HME **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Heated humification (MR 730, Fisher \& Paykel, Auckland, New Zealand), humidification chamber temperature 33°C. **Intervention Names:** - Procedure: Measurements **Label:** HH33 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Heated humification (MR 730, Fisher \& Paykel, Auckland, New Zealand), humidification chamber temperature 33°C. **Intervention Names:** - Procedure: Measurements **Label:** HH37 **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Passive humidification, double tube circuit **Intervention Names:** - Procedure: Measurements **Label:** NoH **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - HH33 - HH37 - HME - NoH **Description:** Measurements of respiratory mechanics and parameters, arterial blood gases and comfort **Name:** Measurements **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Patient's comfort, assessed by visual analogic scale modified for ICU patients **Measure:** Comfort assessed by visual analogic scale modified for ICU patients **Time Frame:** At the end of each 1-hour ventilation period **Description:** Asynchrony index number of asynchrony events divided by the total respiratory rate computed as the sum of the number of ventilator cycles (triggered or not) and of wasted efforts. Inspiratory trigger delay (time between the onset of patient's effort and ventilatory support). Pressurization and depressurization efficacy. **Measure:** Patient-ventilator asynchrony. Asynchrony index **Time Frame:** At the end of each 1-hour ventilation period **Description:** Pressure time product of the esophageal pressure (PTPes) and pressure time product of the transdiaphragmatic pressure (PTPdi) **Measure:** Work of breathing. Oesophageal pressure time product **Time Frame:** At the end of each 1-hour ventilation period #### Secondary Outcomes **Measure:** PaO2 **Time Frame:** At the end of each 1-hour ventilation period **Measure:** respiratory rate **Time Frame:** At the end of each 1-hour ventilation period **Description:** Borg dyspnea score **Measure:** Dyspnea **Time Frame:** At the end of each 1-hour ventilation period **Measure:** Helmet humidity **Time Frame:** At the end of each 1-hour ventilation period **Measure:** Helmet temperature **Time Frame:** At the end of each 1-hour ventilation period **Measure:** PaCO2 **Time Frame:** At the end of each 1-hour ventilation period ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Awake and collaborative patients * Age\>18 years * Need for noninvasive mechanical ventilation * Informed consent Exclusion Criteria: * Cardiopulmonary resuscitation * Haemodynamic instability * Coma * Asma * Hypercapnia (paCO2\>45 mmHg) * Recent gastric or abdominal surgery **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Rome **Country:** Italy **Facility:** General ICU, A. Gemelli hospital **Zip:** 00100 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Bongiovanni F, Grieco DL, Anzellotti GM, Menga LS, Michi T, Cesarano M, Raggi V, De Bartolomeo C, Mura B, Mercurio G, D'Arrigo S, Bello G, Maviglia R, Pennisi MA, Antonelli M. Gas conditioning during helmet noninvasive ventilation: effect on comfort, gas exchange, inspiratory effort, transpulmonary pressure and patient-ventilator interaction. Ann Intensive Care. 2021 Dec 24;11(1):184. doi: 10.1186/s13613-021-00972-9. **PMID:** 34952962 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012120 - Term: Respiration Disorders - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14968 - Name: Respiratory Insufficiency - Relevance: HIGH - As Found: Respiratory Failure - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012131 - Term: Respiratory Insufficiency ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02771379 **Acronym:** PAROS **Brief Title:** Post Authorisation Safety Study With Raxone in LHON Patients **Official Title:** A Non-interventional Study of Clinical Experience in Patients Prescribed Raxone® for the Treatment of Leber's Hereditary Optic Neuropathy (LHON) #### Organization Study ID Info **ID:** SNT-IV-003 #### Organization **Class:** INDUSTRY **Full Name:** Santhera Pharmaceuticals ### Status Module #### Completion Date **Date:** 2021-04-16 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-07-16 **Type:** ACTUAL **Last Update Submit Date:** 2021-07-15 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-04-16 **Type:** ACTUAL #### Start Date **Date:** 2016-09 **Status Verified Date:** 2021-07 #### Study First Post Date **Date:** 2016-05-13 **Type:** ESTIMATED **Study First Submit Date:** 2016-04-25 **Study First Submit QC Date:** 2016-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Santhera Pharmaceuticals #### Responsible Party **Type:** SPONSOR ### Description Module **Brief Summary:** This study is a multicentre, prospective, non-interventional post-authorisation safety study (PASS) of the clinical outcomes for patients with LHON treated with Raxone®. No medication will be provided as part of this study. Raxone® will be obtained through commercial channels. ### Conditions Module **Conditions:** - Leber's Hereditary Optic Neuropathy (LHON) ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 229 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Idebenone **Label:** Patients who are treated with Raxone® ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients who are treated with Raxone® **Description:** Raxone 900mg/day as per Raxone SmPC and medical judgement of treating physician. **Name:** Idebenone **Other Names:** - Raxone® **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Safety will be assessed by the collection and analysis of adverse events of special interest (AESIs), frequency and nature of AEs and serious adverse events (SAEs), adverse drug reactions (ADRs) and serious adverse drug reactions (SADRs) **Measure:** Long-term safety profile of Raxone® in the treatment of patients with LHON when used under conditions of routine clinical care. **Time Frame:** up to 5 years #### Secondary Outcomes **Description:** According to the Summary of Product Characteristics (SmPC) a patient's vision should be continually monitored therefore effectiveness will be assessed by measuring on-therapy changes in patients' visual acuity (VA), visual fields (VF), colour contrast sensitivity and Retinal Nerve Fibre Layer thickness (RNFL) where available. **Measure:** Long-term effectiveness of Raxone® in the treatment of patients with LHON when used under conditions of routine clinical care **Time Frame:** up to 5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patient prescribed Raxone® for the treatment of LHON; * Patient has completed an Informed Consent Form (ICF) indicating that he/she (or a legally acceptable representative) has been informed of all pertinent aspects of the study and has agreed to participate in the study; * Patient is not participating in any interventional study. Exclusion Criteria: * No explicit exclusion criteria exist to avoid selection bias and to allow for documentation of routine clinical practice. **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Patient prescribed Raxone® for the treatment of LHON who have completed the informed consent. This study will be conducted in EU in approximately 45 highly specialized centres in ophthalmology and neuroophthalmology. ### Contacts Locations Module #### Locations **Location 1:** **City:** Graz **Country:** Austria **Facility:** Universitaetsklinikum Graz **Zip:** 8036 **Location 2:** **City:** Vienna **Country:** Austria **Facility:** Medical University of Vienna **Location 3:** **City:** Nîmes **Country:** France **Facility:** CHU de Nîmes - Hôpital Carémeau **State:** Gard **Zip:** 30029 **Location 4:** **City:** Angers **Country:** France **Facility:** CHU Angers - Hôpital Hôtel Dieu **State:** Maine Et Loire **Zip:** 49033 **Location 5:** **City:** Lille **Country:** France **Facility:** Hopital Roger Salengro - CHU Lille **State:** Nord **Zip:** 59037 **Location 6:** **City:** Paris **Country:** France **Facility:** Hôpital Européen Georges Pompidou **State:** Paris Cedex 15 **Zip:** 75908 **Location 7:** **City:** Amiens **Country:** France **Facility:** CHU Amiens - Centre Saint Victor **State:** Somme **Zip:** 80054 **Location 8:** **City:** Lyon Cedex **Country:** France **Facility:** Hopital Neurologique Pierre Wertheimer **Zip:** 69677 **Location 9:** **City:** Lyon **Country:** France **Facility:** Hospices Civils de Lyon **Zip:** 69002 **Location 10:** **City:** Paris **Country:** France **Facility:** Centre Hospitalier National d'Ophtalmologie (CHNO) des Quinze-Vingts **Zip:** 75012 **Location 11:** **City:** Paris **Country:** France **Facility:** Fondation Ophtalmologique Adolphe de Rothschild **Zip:** 75019 **Location 12:** **City:** Wuerzburg **Country:** Germany **Facility:** Julius Maximilians University **State:** Bavaria **Zip:** 97070 **Location 13:** **City:** Essen **Country:** Germany **Facility:** Universitaetsklinikum Essen **Location 14:** **City:** Freiburg **Country:** Germany **Facility:** Universitaetsklinikum Freiburg **Location 15:** **City:** Hamburg **Country:** Germany **Facility:** Universitaetsklinikum Hamburg-Eppendorf **Zip:** 20246 **Location 16:** **City:** Heidelberg **Country:** Germany **Facility:** Universitaetsklinikum Heidelberg **Location 17:** **City:** Munich **Country:** Germany **Facility:** Friedrich-Baur-Institut **Location 18:** **City:** Munster **Country:** Germany **Facility:** Universitaetsklinikum Muenster **Location 19:** **City:** Neubrandenburg **Country:** Germany **Facility:** Dietrich-Bonhoeffer-Klinikum Neubrandenburg **Location 20:** **City:** Regensburg **Country:** Germany **Facility:** Universitaetsklinikum Regensburg **Location 21:** **City:** Athens **Country:** Greece **Facility:** Athens Ophthalmological Center **Zip:** 11528 **Location 22:** **City:** Bologna **Country:** Italy **Facility:** Università di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche **Zip:** 40123 **Location 23:** **City:** Milano **Country:** Italy **Facility:** Ospedale San Raffaele **Zip:** 20132 **Location 24:** **City:** Rome **Country:** Italy **Facility:** Azienda Ospedaliera S. Camillo Forlanini **Zip:** 00152 **Location 25:** **City:** Groningen **Country:** Netherlands **Facility:** Universitair Medisch Centrum Groningen **Zip:** 9713 GZ **Location 26:** **City:** Maastricht **Country:** Netherlands **Facility:** Maastricht University Medical Center **Zip:** 6211 LK ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003389 - Term: Cranial Nerve Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000005128 - Term: Eye Diseases - ID: D000015418 - Term: Optic Atrophies, Hereditary - ID: D000009896 - Term: Optic Atrophy - ID: D000020271 - Term: Heredodegenerative Disorders, Nervous System - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000015785 - Term: Eye Diseases, Hereditary - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000028361 - Term: Mitochondrial Diseases - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12832 - Name: Optic Nerve Diseases - Relevance: HIGH - As Found: Optic Neuropathy - ID: M23422 - Name: Optic Atrophy, Hereditary, Leber - Relevance: HIGH - As Found: Leber's Hereditary Optic Neuropathy - ID: M4589 - Name: Atrophy - Relevance: LOW - As Found: Unknown - ID: M12827 - Name: Optic Atrophy - Relevance: LOW - As Found: Unknown - ID: M18093 - Name: Optic Atrophies, Hereditary - Relevance: LOW - As Found: Unknown - ID: M6605 - Name: Cranial Nerve Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: M22092 - Name: Heredodegenerative Disorders, Nervous System - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M18339 - Name: Eye Diseases, Hereditary - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M23341 - Name: Mitochondrial Diseases - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: T3352 - Name: Leber Hereditary Optic Neuropathy - Relevance: HIGH - As Found: Leber's Hereditary Optic Neuropathy ### Condition Browse Module - Meshes - ID: D000009901 - Term: Optic Nerve Diseases - ID: D000029242 - Term: Optic Atrophy, Hereditary, Leber ### Intervention Browse Module - Ancestors - ID: D000000975 - Term: Antioxidants - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000020011 - Term: Protective Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M273909 - Name: Idebenone - Relevance: HIGH - As Found: Pulmonary Nodules - ID: M4292 - Name: Antioxidants - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000036619 - Term: Idebenone ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04214379 **Brief Title:** Management of Severe Congenital Blepharoptosis **Official Title:** Evaluation of Polytetrafluoroethylene (Ptose-up) in Management of Severe Congenital Blepharoptosis #### Organization Study ID Info **ID:** Oculoplastic Unit #### Organization **Class:** OTHER **Full Name:** Minia University ### Status Module #### Completion Date **Date:** 2018-09-17 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2020-01-03 **Type:** ACTUAL **Last Update Submit Date:** 2019-12-31 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2018-03-10 **Type:** ACTUAL #### Start Date **Date:** 2017-02-01 **Type:** ACTUAL **Status Verified Date:** 2019-12 #### Study First Post Date **Date:** 2020-01-02 **Type:** ACTUAL **Study First Submit Date:** 2019-12-28 **Study First Submit QC Date:** 2019-12-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Minia University #### Responsible Party **Investigator Affiliation:** Minia University **Investigator Full Name:** Mohamed Farag Khalil Ibrahiem **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Frontalis sling surgery was carried out using Ptose-up under general anaesthesia for patients with severe congenital ptosis. **Detailed Description:** Frontalis sling surgery was carried out using Ptose-up for patients with severe congenital ptosis in 23 eyes of 15 patients and they followed up for at least 6 months to detect the success rate and if there is any postoperative complications. ### Conditions Module **Conditions:** - Blepharoptosis ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 15 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with severe congenital ptosis with poor levator muscle function **Intervention Names:** - Procedure: Ptosis surgery **Label:** severe congenital ptosis **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - severe congenital ptosis **Description:** Frontalis sling surgery using pose-up and Wright's fascia-lata needle **Name:** Ptosis surgery **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The average marginal reflex distance was improved from -0.8 mm preoperative to +2.73 mm after 3 months **Measure:** Improvement of ptosis **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Severe congenital blepharoptosis * Poor levator muscle function * No previous ptosis surgery Exclusion Criteria: * Patients with Jaw winking phenomenon * Blepharophimosis syndrome * Congenital myasthenia **Maximum Age:** 9 Years **Minimum Age:** 11 Months **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Minya **Country:** Egypt **Facility:** Faculty of Medicine **State:** Minia **Zip:** 61111 #### Overall Officials **Official 1:** **Affiliation:** Minia University **Name:** Mohamed F Ibrahiem, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005141 - Term: Eyelid Diseases - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5044 - Name: Blepharoptosis - Relevance: HIGH - As Found: Blepharoptosis - ID: M8284 - Name: Eyelid Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001763 - Term: Blepharoptosis ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03037879 **Brief Title:** Treating Cognitive Deficits in Spinal Cord Injury **Official Title:** Treating Cognitive Deficits in Traumatic Spinal Cord Injury: A Randomized Clinical Trial #### Organization Study ID Info **ID:** WEC-16-059 #### Organization **Class:** FED **Full Name:** James J. Peters Veterans Affairs Medical Center ### Status Module #### Completion Date **Date:** 2021-09-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-06-26 **Type:** ACTUAL **Last Update Submit Date:** 2023-06-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-09-30 **Type:** ACTUAL #### Start Date **Date:** 2017-04-13 **Type:** ACTUAL **Status Verified Date:** 2023-06 #### Study First Post Date **Date:** 2017-01-31 **Type:** ESTIMATED **Study First Submit Date:** 2017-01-25 **Study First Submit QC Date:** 2017-01-27 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Kessler Foundation #### Lead Sponsor **Class:** FED **Name:** James J. Peters Veterans Affairs Medical Center #### Responsible Party **Investigator Affiliation:** James J. Peters Veterans Affairs Medical Center **Investigator Full Name:** Jill M. Wecht, Ed.D. **Investigator Title:** Research Health Scientist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Multiple studies in the spinal cord injury (SCI) population have documented deficits in learning and memory (LM) and processing speed (PS) that adversely impact daily life and the ability to benefit from rehabilitation. The investigators have previously attributed the cognitive deficits demonstrated in the SCI population to low blood pressure (BP) and cerebral blood flow (CBF) and are currently conducting a study to determine the effect of a 30-day elevation in BP (using midodrine hydrochloride - an alpha agonist) on CBF and cognitive performance compared to placebo in hypotensive individuals with SCI. In addition, the investigators believe that cognitive behavior therapy (CBT) may improve cognition independent of changes in BP and CBF in individuals with SCI. The current randomized clinical trial (RCT) will examine the efficacy of 2 treatment protocols shown to be effective in improving cognitive performance in other neurologically impaired populations for use in persons with SCI demonstrating (1) LM impairment and/or (2) PS impairment on objective measures of cognitive functioning during a complete Neuropsychological assessment. Two methods of outcome assessment will be used to examine treatment impact: (1) a traditional Neuropsychological assessment (NP) and (2) an assessment of global functioning (AGF) composed of broader outcome measures that examine the impact of the treatment on everyday life activities. In this way, the investigators will be able to objectively evaluate the presence or absence of changes in memory performance through a NP assessment, while also evaluating the impact of this treatment protocol on everyday life through the AGF. While most studies evaluating the efficacy of cognitive retraining usually employ a pre- and post-training evaluation, such evaluations have been criticized for their lack of ecological validity (i.e., real world generalizability). The present design allows the assessment of the efficacy of these treatment techniques within an SCI population using traditional measures, as well as the assessment of the impact that treatment has on everyday life. The investigators will additionally evaluate the long-term efficacy by including a 6-month post-treatment follow-up. Few studies examine long-term effects, but given the time, labor and expense involved, it is critical to demonstrate long-term efficacy. **Detailed Description:** 104 individuals with SCI will be recruited for eligibility to participate in the study. Participants will be randomly assigned to 4 groups (n=26 per group) story memory technique (mSMT), mSMT control, speed of processing training (SPT) and SPT control. The study involves 14 visits spread over 8 months. A screening visit, lasting approximately 1 hour. 3 testing sessions lasting 3-4 hours each (Baseline, Immediate and Long-term follow-ups), and 10 intervention sessions that will last approximately 45 minutes each. Screening: Prior to enrollment in the study protocol, all potential subjects will undergo cognitive screening to determine eligibility for participation. Baseline: After passing screening, subjects will be scheduled for the baseline evaluation comprised of a cardiovascular/cerebrovascular assessment and cognitive evaluation. Intervention: Subjects will undergo 10 sessions of training in one of the 4 randomized groups. Immediate Follow-up Assessment: Subjects will undergo a repeat of the baseline assessments upon completion of the intervention protocol to document changes in PS, LM, BP and CBF following treatment. Long-Term Follow-up: Subjects will be asked to return to the laboratory 6 months following the intervention for evaluation of the maintenance of the treatment effect over time. Baseline and Immediate follow-up measures of PS, LM, BP and CBF will be documented. ### Conditions Module **Conditions:** - Spinal Cord Injury - Blood Pressure - Cerebral Blood Flow - Cognitive Function ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 10 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Speed of Processing Training **Intervention Names:** - Other: SPT **Label:** SPT **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Control group to SPT treatment group **Intervention Names:** - Other: SPT Control **Label:** Control Group SPT **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Story Memory Technique **Intervention Names:** - Other: mSMT **Label:** mSMT **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Control group to mSMT treatment group **Intervention Names:** - Other: mSMT Control **Label:** Control mSMT **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - SPT **Description:** Participants in the SPT group will receive 10 training sessions over 5 weeks. **Name:** SPT **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Control Group SPT **Description:** Participants in the SPT control group will receive 10 computer-based control sessions over a five-week period during which they will engage in computer-based training. However, they will not be exposed to the training materials central to the SPT. **Name:** SPT Control **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - mSMT **Description:** Participants in the mSMT group will meet with the trainer twice per week for five weeks. Sessions last 45-60 minutes each and are spread over 5 weeks. **Name:** mSMT **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - Control mSMT **Description:** Participants in the mSMT control group will meet with the therapist at the same frequency and for the same duration as those in the mSMT experimental group. However, subjects will not be exposed to the training materials central to the mSMT. **Name:** mSMT Control **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** NP testing will be conducted to document levels of cognitive performance. NP assessment will identify persons who qualifies for study participation. **Measure:** Neuropsychological Tests [Change from baseline at immediate follow up (post treatment) and long term follow-up (6months post treatment)] **Time Frame:** Screening (before baseline measures), Baseline, Immediate Follow-up (about 2 months after baseline), Long-term Follow-up (6 months after immediate follow-up) #### Secondary Outcomes **Description:** Brachial BP will be measured by a trained technician using a standard adult BP cuff (GE Healthcare Information Technologies, Milwaukee, WI) at 60-second intervals. Beat-to-beat finger arteriolar BP will be monitored continuously from the left middle or ring finger using photoplethysmography (FMS: Finometer, model 2; Amsterdam, Netherlands). **Measure:** Systolic Blood Pressure [Change from baseline at immediate follow up (post treatment) and long term follow-up (6months post treatment)] **Time Frame:** Baseline, Immediate Follow-up (about 2 months after baseline), Long-term Follow-up (6 months after immediate follow-up) **Description:** Brachial BP will be measured by a trained technician using a standard adult BP cuff (GE Healthcare Information Technologies, Milwaukee, WI) at 60-second intervals. Beat-to-beat finger arteriolar BP will be monitored continuously from the left middle or ring finger using photoplethysmography (FMS: Finometer, model 2; Amsterdam, Netherlands). **Measure:** Diastolic Blood Pressure [Change from baseline at immediate follow up (post treatment) and long term follow-up (6months post treatment)] **Time Frame:** Baseline, Immediate Follow-up (about 2 months after baseline), Long-term Follow-up (6 months after immediate follow-up) **Description:** A transcranial Doppler (TCD) ultrasound probe will be used to locate the left middle cerebral artery (MCA). Once the MCA is located a head harness will be used to secure probe placement for assessment of resting cerebral blood flow velocity (CBFv). **Measure:** Cerebral Blood Flow Velocity [Change from baseline at immediate follow up (post treatment) and long term follow-up (6months post treatment)] **Time Frame:** Baseline, Immediate Follow-up (about 2 months after baseline), Long-term Follow-up (6 months after immediate follow-up) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Primary language is English; * Level of Spinal Cord Injury between C1 and T12; * Non-ambulatory (wheelchair dependent); * American Spinal Injury Association (AISA) grade A, B or C; * Spinal Cord Injury occurred more than 1 year ago. Exclusion Criteria: * Acute illness or infection. * Documented history of: * Controlled or uncontrolled Hypertension or Diabetes Mellitus; * Stroke; * Multiple sclerosis \& Parkinson's disease; * Psychiatric disorders (post-traumatic stress disorder, schizophrenia; bipolar disorder); * Pre-screen MoCA score of \< 22 (to rule out dementia); * Vision impaired - more than 20/60 in worst eye (with prescription eyewear). * Currently prescribed steroids, benzodiazepines, or neuroleptics. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** West Orange **Country:** United States **Facility:** Kessler Foundation **State:** New Jersey **Zip:** 07052 #### Overall Officials **Official 1:** **Affiliation:** James J. Peters VA Medical Center **Name:** Jill M Wecht, Ed.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013118 - Term: Spinal Cord Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000020196 - Term: Trauma, Nervous System - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M29705 - Name: Cognitive Dysfunction - Relevance: HIGH - As Found: Cognitive Deficits - ID: M6301 - Name: Cognition Disorders - Relevance: HIGH - As Found: Cognitive Deficits - ID: M15916 - Name: Spinal Cord Injuries - Relevance: HIGH - As Found: Spinal Cord Injury - ID: M17685 - Name: Wounds and Injuries - Relevance: HIGH - As Found: Injury - ID: M15915 - Name: Spinal Cord Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M22023 - Name: Trauma, Nervous System - Relevance: LOW - As Found: Unknown - ID: M21836 - Name: Neurocognitive Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013119 - Term: Spinal Cord Injuries - ID: D000014947 - Term: Wounds and Injuries - ID: D000003072 - Term: Cognition Disorders - ID: D000060825 - Term: Cognitive Dysfunction ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04081779 **Brief Title:** Survivorship Care Plans and Telehealth Education for the Improvement of Access to Cancer Survivorship, the IMPACT Study **Official Title:** IMPACT: Improving Access to Cancer Survivorship Via Telehealth #### Organization Study ID Info **ID:** RG1005815 #### Organization **Class:** OTHER **Full Name:** Fred Hutchinson Cancer Center #### Secondary ID Infos **Domain:** CTRP (Clinical Trial Reporting Program) **ID:** NCI-2019-05726 **Type:** REGISTRY **Domain:** Fred Hutch/University of Washington Cancer Consortium **ID:** 10267 **Type:** OTHER **ID:** P30CA015704 **Link:** https://reporter.nih.gov/quickSearch/P30CA015704 **Type:** NIH **ID:** R21CA258105 **Link:** https://reporter.nih.gov/quickSearch/R21CA258105 **Type:** NIH ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-01-11 **Type:** ACTUAL **Last Update Submit Date:** 2024-01-09 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2020-02-19 **Type:** ACTUAL **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2019-09-09 **Type:** ACTUAL **Study First Submit Date:** 2019-08-29 **Study First Submit QC Date:** 2019-09-06 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Cancer Institute (NCI) #### Lead Sponsor **Class:** OTHER **Name:** Fred Hutchinson Cancer Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This trial studies how well self-generated survivorship care plans and telehealth education works in improving knowledge and self-efficacy in cancer survivors living in rural areas. Patients living in rural areas often face barriers to survivorship care and report unmet needs. A survivorship care plan created by the patient (self-generated) may help them to better transition from oncology to primary care and improve communication between care teams in order to meet these needs and create better health outcomes. Telehealth is a way of delivering health care services from a distance, including patient education. Combining a self-generated survivorship care plan with telehealth education may help to improve knowledge and self-efficacy in cancer survivors. **Detailed Description:** OUTLINE: Patients complete a questionnaire at baseline (paper, online, or telephone-based) and medical records are reviewed. Patients are then randomized to 1 of 2 arms. ARM I: Patients receive a self-generated SCP (i.e., generated from baseline questionnaire responses). ARM II: Patients receive a self-generated SCP as in Arm I. Patients also receive a 30-minute telephone-based educational counseling session on survivorship care. PRIMARY CARE PROVIDERS: Primary care providers complete a questionnaire about perceptions of the SCP and self-efficacy in providing survivorship care. ONCOLOGY CLINIC STAFF: Administrators and medical providers will be asked to complete the adapted Organizational Readiness to Change Assessment (ORCA) instrument (that measures Evidence and Context only) and participate in a qualitative interview about perceptions of implementation of survivorship care. After completion of study, patients are followed up at approximately 8 weeks. ### Conditions Module **Conditions:** - Breast Carcinoma - Colorectal Carcinoma - Lung Carcinoma - Lymphoma - Prostate Carcinoma **Keywords:** - Cancer survivors - survivorship care plans - primary care ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Masking Description:** Personnel other than the statisticians and lay health educators **Who Masked:** - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients receive a self-generated SCP (i.e., generated from baseline questionnaire responses). **Intervention Names:** - Other: Survivorship Care Plan - Other: Questionnaire Administration **Label:** Arm I (patient-generated SCP) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Patients receive a self-generated SCP as in Arm I. Patients also receive a 30-minute telephone-based educational counseling session on survivorship care administered by trained lay health counselors. **Intervention Names:** - Other: Survivorship Care Plan - Other: Educational Intervention - Other: Questionnaire Administration **Label:** Arm II (patient-generated SCP, educational counseling) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Arm I (patient-generated SCP) - Arm II (patient-generated SCP, educational counseling) **Description:** Receive patient-generated SCP **Name:** Survivorship Care Plan **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Arm II (patient-generated SCP, educational counseling) **Description:** Receive telephone-based educational counseling session **Name:** Educational Intervention **Other Names:** - Education for Intervention - Intervention by Education - Intervention through Education - Intervention, Educational **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Arm I (patient-generated SCP) - Arm II (patient-generated SCP, educational counseling) **Description:** Ancillary studies **Name:** Questionnaire Administration **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Initial participation rate of cancer survivors identified from community-based practices **Time Frame:** Up to 8 weeks **Description:** Will measure the accuracy of participants' SCPs by comparing their self-reported medical history collected via questionnaire, with data abstracted from medical records. Accuracy will be reported by percentage of missing data in the self-generated SCP compared to medical records, and percentage of incorrect data in the self-generated SCP compared to medical records. **Measure:** Accuracy of survivors' self-generated survivorship care plans (SCPs) in relation to those based on medical record abstraction **Time Frame:** Up to 8 weeks **Measure:** Proportion of survivors who receive the phone-based education session within the study time period **Time Frame:** Up to 8 weeks **Measure:** Proportion of survivors who complete the follow-up questionnaire within the study time period **Time Frame:** Up to 8 weeks **Measure:** Response rate among primary care providers (PCPs) to the PCP survey **Time Frame:** Up to 8 weeks #### Secondary Outcomes **Description:** The effects of the intervention versus (vs.) control on participant perceived self-efficacy will be measured at baseline and at the end of the study via a questionnaire using the PROMIS Global 10 and health related self-efficacy scales. **Measure:** Participant perceived self-efficacy: questionnaire using the PROMIS Global 10 and health related self-efficacy scales **Time Frame:** Up to 8 weeks **Description:** The effects of the intervention vs. control on survivorship knowledge will be measured at baseline and at the end of the study via a questionnaire. **Measure:** Survivorship knowledge **Time Frame:** Up to 8 weeks **Description:** The effects of the intervention vs. control on PCP self-efficacy towards survivorship care will be measured at baseline and at the end of the study via a questionnaire using the PROMIS Global 10 and health related self-efficacy scales. **Measure:** PCP self-efficacy towards survivorship care **Time Frame:** Up to 8 weeks **Description:** Assess oncology practitioners' and clinic administrators' views on utility and feasibility of implementing SCPs in target clinics, using the ORCA (Organizational Readiness to Change Assessment) instrument and qualitative interviewing **Measure:** Local oncology clinics' attitudes towards survivorship care implementation **Time Frame:** Up to 8 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Cancer survivors who have completed curative therapy within the past 5 years (may still currently be on long-term/targeted non-cytotoxic agent maintenance therapy, e.g., tamoxifen or aromatase inhibitors for breast cancer survivors; androgen deprivation therapy for prostate cancer survivors) * History of either adult-onset (age \>= 18) lymphoma, breast, colorectal, lung, or prostate cancer * Able to perform all study requirements, including responding to questionnaires * Willing to be randomized * Capable of providing informed consent * Consent to release oncology and primary care medical records * English or Spanish speakers * PRIMARY CARE PROVIDERS: PCPs responsible for delivering primary care to IMPACT study participants will be contacted about participating in the study after participant enrollment into the study. * ONCOLOGY STAFF: Oncology Staff (Oncologists, Nurse Practitioners, Physician's assistants) will be recruited from sites involved in the IMPACT study * CLINIC ADMINISTRATORS: Clinic administrators will be recruited from sites involved in the IMPACT study Exclusion Criteria: * Currently on palliative or hospice care, or considering transferring to such care within the next 3 months * Lacks telephone access * Lacks mailing address or ability to receive study materials electronically * Currently being followed in a pediatric clinical setting (either for primary care or for cancer care) * History of having had \> 1 cancer type diagnosed and treated (exception is for skin cancers treated with surgical excision alone; also, individuals who only have had relapse of their initial cancer remain eligible so long as they have completed curative therapy and meet all other eligibility criteria) **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Seattle **Country:** United States **Facility:** Fred Hutch/University of Washington Cancer Consortium **State:** Washington **Zip:** 98109 #### Overall Officials **Official 1:** **Affiliation:** Fred Hutch/University of Washington Cancer Consortium **Name:** Eric Chow **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases - ID: D000007414 - Term: Intestinal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000012002 - Term: Rectal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Carcinoma - ID: M14335 - Name: Prostatic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11220 - Name: Lymphoma - Relevance: LOW - As Found: Unknown - ID: M17890 - Name: Colorectal Neoplasms - Relevance: HIGH - As Found: Colorectal Carcinoma - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M10448 - Name: Intestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M14844 - Name: Rectal Diseases - Relevance: LOW - As Found: Unknown - ID: T3543 - Name: Lymphosarcoma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000001943 - Term: Breast Neoplasms - ID: D000015179 - Term: Colorectal Neoplasms ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05012579 **Brief Title:** Transcutaneous Afferent Patterned Stimulation (TAPS) for Reduction of Parkinson's Disease (PD) Related Action Tremor **Official Title:** A Study of Safety and Efficacy of Transcutaneous Afferent Patterned Stimulation (TAPS) for Reduction of Action Tremor in Parkinson's Disease (PD) #### Organization Study ID Info **ID:** PD-02 #### Organization **Class:** INDUSTRY **Full Name:** Cala Health, Inc. ### Status Module #### Completion Date **Date:** 2021-03-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-02-13 **Type:** ACTUAL **Last Update Submit Date:** 2024-01-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-03-12 **Type:** ACTUAL #### Results First Post Date **Date:** 2024-02-13 **Type:** ACTUAL **Results First Submit Date:** 2023-11-02 **Results First Submit QC Date:** 2024-01-22 #### Start Date **Date:** 2020-11-11 **Type:** ACTUAL **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2021-08-19 **Type:** ACTUAL **Study First Submit Date:** 2021-08-03 **Study First Submit QC Date:** 2021-08-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Cala Health, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Demonstrate safety and efficacy of TAPS delivered by a Cala device as a treatment for action tremor in subjects with Parkinson's disease hand tremor **Detailed Description:** 40 patients with PD with at least mild postural tremor were enrolled in a four-week, prospective, single-arm, open-label study of twice daily TAPS therapy. Due to the COVID-19 pandemic, TAPS devices were shipped to patients to run the study remotely. Unsupervised motion assessments were captured at home, and at the beginning and end of the four weeks by telemedicine. ### Conditions Module **Conditions:** - Parkinson Disease ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Two 40-minute TAPS sessions daily for 28 days, recommended as once in the morning and once in the evening. **Intervention Names:** - Device: Cala Device **Label:** TAPS delivered by Cala device **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - TAPS delivered by Cala device **Description:** transcutaneous afferent patterned stimulation (TAPS) **Name:** Cala Device **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Pre-specified effectiveness endpoints included improvements in (1) objective postural tremor power (primary outcome; assessed using an accelerometer on the device under standard of care medication state at home). **Measure:** Tremor Power **Time Frame:** 4 weeks #### Secondary Outcomes **Description:** Improvement of clinician-ratings of Movement Disorder Society Unified PD Rating Scale (MDS-UPDRS) Part III \[Goetz, C.G. et al. Wiley Intersci. 2008\] (co-secondary; in medication-off state). Clinician rated patients' tremor pre and post therapy on a scale of 0-4. 0=Normal (no tremor), 4=Severe. **Measure:** Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) **Time Frame:** 4 weeks **Description:** Improvement of patient-ratings of the Bain and Findley Activities of Daily Living (BF-ADL) \[Bain PG, et al. Journal of Neurol, Neuros \& Psych 1993\] (co-secondary; in medication-off state). Patients' rated ability to perform specific activities pre and post therapy on a scale from 1-4. 1=Able to do the activity without difficulty, 4=Cannot do the activity by yourself. **Measure:** Bain and Findley Activities of Daily Living (BF-ADL) **Time Frame:** 4 weeks **Description:** Clinician and Patient global impressions of improvement (CGI-I, PGI-I; exploratory) post therapy. This is a rated scale from 1-7, with 1=Very Much Improved to 7=Very Much Worse. Percentage of patients with ratings \< 4 (including very much improved, much improved and improved) were computed respectively for CGI-I and PGI-I. **Measure:** Percentage of Patients With Clinician and Patient Global Impressions of Improvement Rated < 4 (CGI-I, PGI-I) **Time Frame:** 4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Must be ≥22 years of age * Competent and willing to provide written, informed consent to participate in the study * Clinically significant postural tremor as defined by: * Dominant hand/arm exhibiting postural tremor ≥ 2 (while in the off state) as assessed by the MDS-UPDRS postural tremor score * Stable dose of Parkinson's disease medications, if applicable, for 30 days prior to study entry * Willing to comply with study protocol requirements including: * Having the ability to do telemedicine or video calls for study visits * remaining on a stable dosage of Parkinson's medications, if applicable, during the duration of the study * no significant caffeine consumption within 8 hours of study visits Exclusion Criteria: * Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator * Suspected or diagnosed epilepsy or other seizure disorder * Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site * Peripheral neuropathy affecting the tested upper extremity * Presence of any other neurodegenerative disease or dementia. These may include: multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease. * Botulinum toxin injection for hand tremor within 6 months prior to study enrollment * Are participating or have participated in another interventional clinical trial in the last 30 days which may confound the results of this study, unless approved by the Sponsor * Significant caffeine consumption within 8 hours of study enrollment, which may confound the results of the study, where significant caffeine is considered more than 95 mg (equivalent to a cup of coffee). * Subjects unable to communicate with the investigator and staff * Any health condition that in the investigator's opinion should preclude participation in this study * Pregnancy or anticipated pregnancy during the course of the study **Minimum Age:** 22 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Burlingame **Country:** United States **Facility:** Cala Clinic **State:** California **Zip:** 94010 ## Document Section ### Large Document Module #### Large Docs - Date: 2020-10-01 - Filename: Prot_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: False - Label: Study Protocol - Size: 981852 - Type Abbrev: Prot - Upload Date: 2023-11-02T11:41 - Date: 2021-03-25 - Filename: SAP_001.pdf - Has ICF: False - Has Protocol: False - Has SAP: True - Label: Statistical Analysis Plan - Size: 733385 - Type Abbrev: SAP - Upload Date: 2023-11-01T16:28 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020734 - Term: Parkinsonian Disorders - ID: D000001480 - Term: Basal Ganglia Diseases - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009069 - Term: Movement Disorders - ID: D000080874 - Term: Synucleinopathies - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000020820 - Term: Dyskinesias - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M16956 - Name: Tremor - Relevance: HIGH - As Found: Action Tremor - ID: M13213 - Name: Parkinson Disease - Relevance: HIGH - As Found: Parkinson's Disease - ID: M22494 - Name: Parkinsonian Disorders - Relevance: LOW - As Found: Unknown - ID: M25603 - Name: Ganglion Cysts - Relevance: LOW - As Found: Unknown - ID: M16358 - Name: Synovial Cyst - Relevance: LOW - As Found: Unknown - ID: M4774 - Name: Basal Ganglia Diseases - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12029 - Name: Movement Disorders - Relevance: LOW - As Found: Unknown - ID: M2217 - Name: Synucleinopathies - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M22574 - Name: Dyskinesias - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010300 - Term: Parkinson Disease - ID: D000014202 - Term: Tremor ### Misc Info Module #### Submission Tracking ##### First MCP Info ###### Post Date - Date: 2023-11-24 - Type: ACTUAL - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** TAPS Delivered by Cala Device **Deaths Num At Risk:** 40 **Description:** Two 40-minute TAPS sessions daily for 28 days, recommended as once in the morning and once in the evening. Cala Device: transcutaneous afferent patterned stimulation (TAPS) **ID:** EG000 **Other Num Affected:** 8 **Other Num at Risk:** 40 **Serious Number At Risk:** 40 **Title:** TAPS Delivered by Cala Device **Frequency Threshold:** 0 #### Other Events **Term:** Unsteady gait **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** **Term:** sore/lesion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** sore/lesion observed in 2 subjects, on the dominant wrist **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** **Term:** significant and persistent skin irritation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** **Term:** persistent pain from stimulation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** pain felt in thumb of treatment hand **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** **Term:** significant discomfort with stimulation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** **Term:** twitching of ring finger **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** ring finger on treatment hand **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** **Term:** anxiety/insomnia/worsening of tremor at night **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** **Time Frame:** 4 weeks ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 40 **Units:** Participants ### Group **ID:** BG000 **Title:** TAPS Delivered by Cala Device **Description:** Two 40-minute TAPS sessions daily for 28 days, recommended as once in the morning and once in the evening. Cala Device: transcutaneous afferent patterned stimulation (TAPS) ### Measure #### Measurement **Group ID:** BG000 **Spread:** 9.9 **Value:** 67.1 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 10 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 30 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 6 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 1 **Category Title:** African American #### Measurement **Group ID:** BG000 **Value:** 33 **Category Title:** Caucasian **Class Title:** Race **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race/Ethnicity, Customized **Unit of Measure:** Participants **Population Description:** 40 enrolled subjects with PD ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** [email protected] **Organization:** Cala Health **Phone:** 267-973-4180 **Title:** Alex Kent ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 54 - **Spread:** - **Upper Limit:** 79 - **Value:** 64 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.5 - **Upper Limit:** - **Value:** 0.6 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.5 - **Upper Limit:** - **Value:** 0.5 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 80 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 77 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Pre-specified effectiveness endpoints included improvements in (1) objective postural tremor power (primary outcome; assessed using an accelerometer on the device under standard of care medication state at home). **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** 4 weeks **Title:** Tremor Power **Type:** PRIMARY **Unit of Measure:** Percentage of tremor power reduction ##### Group **Description:** Two 40-minute TAPS sessions daily for 28 days, recommended as once in the morning and once in the evening. Cala Device: transcutaneous afferent patterned stimulation (TAPS) **ID:** OG000 **Title:** Single Arm - TAPS Delivered by Cala Device #### Outcome Measure 2 **Description:** Improvement of clinician-ratings of Movement Disorder Society Unified PD Rating Scale (MDS-UPDRS) Part III \[Goetz, C.G. et al. Wiley Intersci. 2008\] (co-secondary; in medication-off state). Clinician rated patients' tremor pre and post therapy on a scale of 0-4. 0=Normal (no tremor), 4=Severe. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 4 weeks **Title:** Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) **Type:** SECONDARY **Unit of Measure:** units on a scale ##### Group **Description:** Two 40-minute TAPS sessions daily for 28 days, recommended as once in the morning and once in the evening. Cala Device: transcutaneous afferent patterned stimulation (TAPS) **ID:** OG000 **Title:** Single Arm - TAPS Delivered by Cala Device #### Outcome Measure 3 **Description:** Improvement of patient-ratings of the Bain and Findley Activities of Daily Living (BF-ADL) \[Bain PG, et al. Journal of Neurol, Neuros \& Psych 1993\] (co-secondary; in medication-off state). Patients' rated ability to perform specific activities pre and post therapy on a scale from 1-4. 1=Able to do the activity without difficulty, 4=Cannot do the activity by yourself. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 4 weeks **Title:** Bain and Findley Activities of Daily Living (BF-ADL) **Type:** SECONDARY **Unit of Measure:** units on a scale ##### Group **Description:** Two 40-minute TAPS sessions daily for 28 days, recommended as once in the morning and once in the evening. Cala Device: transcutaneous afferent patterned stimulation (TAPS) **ID:** OG000 **Title:** Single Arm - TAPS Delivered by Cala Device #### Outcome Measure 4 **Description:** Clinician and Patient global impressions of improvement (CGI-I, PGI-I; exploratory) post therapy. This is a rated scale from 1-7, with 1=Very Much Improved to 7=Very Much Worse. Percentage of patients with ratings \< 4 (including very much improved, much improved and improved) were computed respectively for CGI-I and PGI-I. **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** 4 weeks **Title:** Percentage of Patients With Clinician and Patient Global Impressions of Improvement Rated < 4 (CGI-I, PGI-I) **Type:** SECONDARY **Unit of Measure:** percentage of patients with improvement ##### Group **Description:** Two 40-minute TAPS sessions daily for 28 days, recommended as once in the morning and once in the evening. Cala Device: transcutaneous afferent patterned stimulation (TAPS) **ID:** OG000 **Title:** Single Arm - TAPS Delivered by Cala Device ### Participant Flow Module #### Group **Description:** Two 40-minute TAPS sessions daily for 28 days, recommended as once in the morning and once in the evening. Cala Device: transcutaneous afferent patterned stimulation (TAPS) **ID:** FG000 **Title:** TAPS Delivered by Cala Device #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 40 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 37 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 3 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT05268679 **Acronym:** COVHEART **Brief Title:** Covid-19 Vaccine Response in Heart Transplant Recipients **Official Title:** Study of the Humoral and Cellular Response to Vaccines Against SARS-CoV-2 in Heart Transplant Recipients #### Organization Study ID Info **ID:** APHP211456 #### Organization **Class:** OTHER **Full Name:** Assistance Publique - Hôpitaux de Paris ### Status Module #### Completion Date **Date:** 2022-11-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-01-03 **Type:** ACTUAL **Last Update Submit Date:** 2023-12-30 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-11-30 **Type:** ACTUAL #### Start Date **Date:** 2022-03-07 **Type:** ACTUAL **Status Verified Date:** 2023-12 #### Study First Post Date **Date:** 2022-03-07 **Type:** ACTUAL **Study First Submit Date:** 2022-03-04 **Study First Submit QC Date:** 2022-03-04 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assistance Publique - Hôpitaux de Paris #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Clinical studies indicate a decrease in vaccine efficacy in certain immunocompromised populations (kidney transplant recipients, patients undergoing chemotherapy). It was recently reported that only 18% to 49% of heart transplant recipients developed antibodies after 2 doses of BNT162b2 vaccine. Following the published results, it is currently recommended to use 3 doses in organ transplant recipients who have not contracted COVID-19 and 2 doses in those who have been infected. The effectiveness of this strategy is not yet sufficiently evaluated in heart transplant recipients. Moreover, the factors associated with the humoral and cellular response, the kinetics and durability of the humoral response, the occurrence of the cellular immune response and the tolerance of the vaccine are not well known in this population. To provide answers to these different questions, we set ourselves the objective of evaluating the humoral and cellular response to messenger RNA (mRNA) vaccines in heart transplant recipients followed at Bichat Hospital. **Detailed Description:** In order to evaluate the effectiveness and safety of currently adopted vaccination strategies in heart transplant recipients we intend to study the humoral and cellular responses to SARS-CoV-2 mRNA vaccines in heart transplant recipients followed at Bichat Hospital. All heart transplant recipients followed at Bichat Hospital will be invited to participate in this research. The vaccination schedule was 3 doses for the seronegative patients without documented infection, and 2 doses for patients who were seropositive or had a positive Reverse Transcriptase - Polymerase Chain Reaction (RT-PCR) test for SARS-CoV-2. Most patients were vaccinated at Bichat Hospital. Their vaccination schedule will be recovered. Some patients refused vaccination. Since the beginning of 2020, the transplant patients have benefited from systematic serological tests and RT-PCR testing of nasopharyngeal swabs in the event of symptoms suggestive of SARS-CoV-2 infection as part of routine care. The results of these tests will be retrieved from medical records retrospectively in order to investigate the kinetics and durability of the humoral response. Demographic and clinical data will be collected to determine the factors associated with vaccine response. In addition, a whole blood sample will be drawn at inclusion in order to evaluate cellular response. The patients will be also asked to answer a questionnaire regarding vaccine tolerance. The effectiveness of vaccination program will be assessed after 6-month follow-up based on the occurrence of SARS-CoV-2 infection, unscheduled medical consultation or hospitalization. ### Conditions Module **Conditions:** - Heart Transplantation - COVID-19 Virus Infection - COVID-19 Vaccine **Keywords:** - Heart transplant recipients - Covid-19 virus infection - SARS-CoV-2 vaccine - Vaccine Effectiveness - Humoral immune response - Cellular Immune Response ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** OTHER #### Enrollment Info **Count:** 190 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Heart transplant recipients followed at Bichat Hospital and who were offered vaccination against SARS-CoV-2, regardless of whether they agreed to be vaccinated or not. **Intervention Names:** - Other: Biospecimen Collection - Other: Questionnaire - Other: Electronic Health Record Review **Label:** Heart transplant recipients ### Interventions #### Intervention 1 **Arm Group Labels:** - Heart transplant recipients **Description:** A blood of a sample of 2 x 7 mL will be collected for the analysis of the anti-SARS-CoV-2 T-cell response during a scheduled check-up as part of their routine follow-up **Name:** Biospecimen Collection **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Heart transplant recipients **Description:** Patients who have received SARS-CoV-2 vaccination will be asked to complete the Vaccine tolerance questionnaire **Name:** Questionnaire **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Heart transplant recipients **Description:** For heart transplant recipients who were offered vaccination against SARS-CoV-2 medical records will be reviewed retrospectively. **Name:** Electronic Health Record Review **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Anti-SARS-CoV-2 neutralizing antibody levels over time, with quantification of immunoglobulin G (IgG) directed against the Receptor Binding Domain (RBD) of the Spike (S) protein **Measure:** Anti-SARS-CoV-2 neutralizing antibody levels **Time Frame:** Change from baseline to month 6 **Description:** Search for memory T lymphocytes specific to SARS-CoV-2 using an Elispot interferon γ test during the inclusion visit **Measure:** Efficacy of COVID-19 Vaccines against SARS-CoV-2 infection **Time Frame:** Day 0 #### Secondary Outcomes **Description:** Proportion of vaccinated heart transplant recipients having had an infection documented by RT-PCR and a serious infection requiring hospitalisation **Measure:** Efficacy of COVID-19 vaccines against SARS-CoV-2 infection **Time Frame:** Month 6 **Description:** Patients will be asked to complete the Vaccine tolerance questionnaire where they will asses and evaluate their symptoms. These will include Diffuse muscle pain (on a scale of 10)/ Headache (on a scale of 10)/ Digestive disorders/ Skin rash/ Pain at the injection site (on a scale of 10)/ Fever/ Fatigue/ Other. Lower scores for all symptoms would indicate a better tolerance. **Measure:** Safety of COVID-19 vaccines **Time Frame:** Day 0 **Description:** Change in SARS-CoV-2 Antibody Concentrations following mRNA COVID-19 vaccine series **Measure:** Kinetics of the humoral response **Time Frame:** Change from baseline to month 6 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Heart transplant patients followed at Bichat Hospital * Aged 18 or older * Informed and having expressed their non-objection to participation in this research * Able to give their agreement Exclusion Criteria: * Minors * Heart transplant recipients who have expressed their opposition to their participation * Legally protected adult * Persons under the State Medical Assistance (AME) **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Heart transplant recipients followed at Bichat Hospital and who were offered vaccination against SARS-CoV-2, regardless of whether they agreed to be vaccinated or not. ### Contacts Locations Module #### Locations **Location 1:** **City:** Paris **Country:** France **Facility:** AP-HP, Bichat-Claude Bernard Hospital **Zip:** 75018 #### Overall Officials **Official 1:** **Affiliation:** AP-HP, Bichat-Claude Bernard Hospital **Name:** Richard DORENT, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Peled Y, Ram E, Lavee J, Sternik L, Segev A, Wieder-Finesod A, Mandelboim M, Indenbaum V, Levy I, Raanani E, Lustig Y, Rahav G. BNT162b2 vaccination in heart transplant recipients: Clinical experience and antibody response. J Heart Lung Transplant. 2021 Aug;40(8):759-762. doi: 10.1016/j.healun.2021.04.003. Epub 2021 Apr 21. **PMID:** 34034958 **Citation:** Itzhaki Ben Zadok O, Shaul AA, Ben-Avraham B, Yaari V, Ben Zvi H, Shostak Y, Pertzov B, Eliakim-Raz N, Abed G, Abuhazira M, Barac YD, Mats I, Kramer MR, Aravot D, Kornowski R, Ben-Gal T. Immunogenicity of the BNT162b2 mRNA vaccine in heart transplant recipients - a prospective cohort study. Eur J Heart Fail. 2021 Sep;23(9):1555-1559. doi: 10.1002/ejhf.2199. Epub 2021 May 14. **PMID:** 33963635 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007239 - Term: Infections - ID: D000011024 - Term: Pneumonia, Viral - ID: D000011014 - Term: Pneumonia - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000018352 - Term: Coronavirus Infections - ID: D000003333 - Term: Coronaviridae Infections - ID: D000030341 - Term: Nidovirales Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M2561 - Name: COVID-19 - Relevance: HIGH - As Found: COVID-19 - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: HIGH - As Found: Virus Infection - ID: M13904 - Name: Pneumonia - Relevance: LOW - As Found: Unknown - ID: M13914 - Name: Pneumonia, Viral - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M20490 - Name: Coronavirus Infections - Relevance: LOW - As Found: Unknown - ID: M6555 - Name: Coronaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M23685 - Name: Nidovirales Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000086382 - Term: COVID-19 - ID: D000014777 - Term: Virus Diseases ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M17360 - Name: Vaccines - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03711279 **Brief Title:** A Study of SHR-1210 Plus Apatinib in Patients With Soft Tissue Sarcoma **Official Title:** A Multicenter, Randomized, Open, Phase 2 Trial of SHR-1210 Plus Apatinib Versus Doxorubicin (ADM) Plus Ifosfamide (IFO) in Patients With Soft Tissue Sarcoma #### Organization Study ID Info **ID:** SHR-1210-II-212 #### Organization **Class:** INDUSTRY **Full Name:** Jiangsu HengRui Medicine Co., Ltd. ### Status Module #### Completion Date **Date:** 2021-06-21 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-02-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-02-27 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2021-06-21 **Type:** ACTUAL #### Results First Post Date **Date:** 2024-02-29 **Type:** ACTUAL **Results First Submit Date:** 2023-07-13 **Results First Submit QC Date:** 2024-02-27 #### Start Date **Date:** 2018-11-22 **Type:** ACTUAL **Status Verified Date:** 2023-07 #### Study First Post Date **Date:** 2018-10-18 **Type:** ACTUAL **Study First Submit Date:** 2018-10-16 **Study First Submit QC Date:** 2018-10-16 **Why Stopped:** Sponsor R \& D Strategy Adjustment ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Jiangsu HengRui Medicine Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The main purpose of this study is to evaluate the efficacy of SHR-1210 plus Apatinib versus AMD plus IFO in participants with soft tissue sarcoma. ### Conditions Module **Conditions:** - Sarcoma **Keywords:** - Sarcoma - SHR-1210 - Apatinib ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 99 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: SHR-1210 plus Apatinib **Label:** SHR-1210 plus Apatinib **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: ADM plus IFO or IFO alone **Label:** ADM plus IFO or IFO alone **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - SHR-1210 plus Apatinib **Description:** SHR-1210 200 mg q3w+ Apatinib 500 mg qd **Name:** SHR-1210 plus Apatinib **Other Names:** - PD-1 antibody + Anti-angiogenesis **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - ADM plus IFO or IFO alone **Description:** ADM 60 mg/m2 D1 + IFO 2 g/m2 D1-D4 q3w；if the cumulative doses of ADM were beyond 450 mg/m2, the monotherapy of IFO (2 g/m2 D1-D5 q3w) would be used. **Name:** ADM plus IFO or IFO alone **Other Names:** - chemotherapy **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Randomization to Radiographic Progression or Death Due to Any Cause (Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions) **Measure:** Progression Free Survival (PFS) **Time Frame:** From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 31 months, CT was conducted at baseline、weeks 7、13、19 and then every 12 weeks. #### Secondary Outcomes **Description:** Baseline to documented disease Remission to study discontinuation, Partial Remission is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 30% decrease in the sum of the beaseline diameter of target lesions. **Measure:** Objective Response Rate (ORR) **Time Frame:** From date of randomization until the date of study completion, an average of 1 year, CT was conducted at baseline、weeks 7、13、19 and then every 12 weeks. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or female subjects with the age from 16 years to 70 years. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;the ECOG performance status of 2 can be accepted after the amputation. * Life expectancy of at least 3 months. * Histologically confirmed diagnosis of advanced unresectable or metastatic soft tissue sarcoma not amenable to curative treatment with surgery or radiotherapy.The histopathologic types as specified in the protocol. * Without prior systemic chemotherapy or relapse more than 6 months after the completion of last systemic chemotherapy. * Presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). * Acceptable liver function, renal function, hematologic status and coagulation function as specified in the protocol. * Females of child-bearing potential must have a negative serum pregnancy test within 7 days prior to randomization.Females of child-bearing potential and males must agree to use highly effective contraceptive precautions during the trial and up to 3 months following the last dose of study drug. * Willingness to comply with the study protocol for any reason. Exclusion Criteria: * Receiving any previous anticancer treatment, other investigational drugs or any attenuated live vaccine with 4 weeks of the first does of study drug. * Prior treatment with PD-1/PD-L1/CTLA-4 targeted drugs or VEGFR targeted drugs. * Plan to receive surgery or radiotherapy to treat the sarcoma during the trail. * Radiological evidence of brain metastases or primary tumors. * Diagnosed other malignancies within the last 3 years from the first dose of drug. * Known allergy to any of the treatment components. * Active infection including human immunodeficiency virus (HIV) ,HBV or HCV. * Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study. **Maximum Age:** 70 Years **Minimum Age:** 16 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Shanghai **Country:** China **Facility:** Shanghai Jiao Tong University Affiliated Sixth People's Hospital **State:** Shanghai #### Overall Officials **Official 1:** **Affiliation:** Shanghai Jiao Tong University Affiliated Sixth People's Hospital **Name:** Yang Yao, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Document Section ### Large Document Module #### Large Docs - Date: 2019-02-25 - Filename: Prot_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: False - Label: Study Protocol - Size: 1509670 - Type Abbrev: Prot - Upload Date: 2023-07-13T22:23 - Date: 2020-11-23 - Filename: SAP_001.pdf - Has ICF: False - Has Protocol: False - Has SAP: True - Label: Statistical Analysis Plan - Size: 626551 - Type Abbrev: SAP - Upload Date: 2023-07-13T22:24 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000018204 - Term: Neoplasms, Connective and Soft Tissue - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15327 - Name: Sarcoma - Relevance: HIGH - As Found: Sarcoma - ID: M20350 - Name: Neoplasms, Connective and Soft Tissue - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: T5284 - Name: Soft Tissue Sarcoma - Relevance: HIGH - As Found: Soft Tissue Sarcoma ### Condition Browse Module - Meshes - ID: D000012509 - Term: Sarcoma ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000047428 - Term: Protein Kinase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M7492 - Name: Doxorubicin - Relevance: LOW - As Found: Unknown - ID: M227339 - Name: Liposomal doxorubicin - Relevance: LOW - As Found: Unknown - ID: M288166 - Name: Apatinib - Relevance: HIGH - As Found: HER2 - ID: M10117 - Name: Ifosfamide - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M230811 - Name: Isophosphamide mustard - Relevance: LOW - As Found: Unknown - ID: M25820 - Name: Protein Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000553458 - Term: Apatinib ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module **Description:** Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. #### Event Groups **Group ID:** EG000 **Title:** SHR-1210 Plus Apatinib **Deaths Num Affected:** 2 **Deaths Num At Risk:** 50 **Description:** SHR-1210 200 mg q3w+ Apatinib 500 mg qd **ID:** EG000 **Other Num Affected:** 50 **Other Num at Risk:** 50 **Serious Number Affected:** 27 **Serious Number At Risk:** 50 **Title:** SHR-1210 Plus Apatinib **Group ID:** EG001 **Title:** ADM Plus IFO or IFO Alone **Deaths Num Affected:** 2 **Deaths Num At Risk:** 47 **Description:** ADM 60 mg/m2 D1 + IFO 2 g/m2 D1-D4 q3w；if the cumulative doses of ADM were beyond 450 mg/m2, the monotherapy of IFO (2 g/m2 D1-D5 q3w) would be used. **ID:** EG001 **Other Num Affected:** 45 **Other Num at Risk:** 47 **Serious Number Affected:** 13 **Serious Number At Risk:** 47 **Title:** ADM Plus IFO or IFO Alone **Frequency Threshold:** 5 #### Other Events **Term:** Anaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** **Term:** Coagulopathy **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** **Term:** Sinus tachycardia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** **Term:** Hypothyroidism **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Endocrine disorders **Source Vocabulary:** **Term:** Hyperthyroidism **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Endocrine disorders **Source Vocabulary:** **Term:** Diarrhoea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Mouth ulceration **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Nausea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Vomiting **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Constipation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Abdominal pain upper **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Abdominal pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Stomatitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Abdominal distension **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Abdominal pain lower **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Gingival pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Abdominal discomfort **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** **Term:** Asthenia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** **Term:** Pyrexia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** **Term:** Chest discomfort **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** **Term:** Chest pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** **Term:** Fatigue **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** **Term:** Oedema peripheral **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** **Term:** Reactive capillary endothelial proliferation **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Immune system disorders **Source Vocabulary:** **Term:** Upper respiratory tract infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** **Term:** Urinary tract infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** **Term:** Nasopharyngitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** **Term:** Pneumonia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** **Term:** Aspartate aminotransferase increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Alanine aminotransferase increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** White blood cell count decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Platelet count decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Gamma-glutamyltransferase increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Weight decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Neutrophil count decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Blood alkaline phosphatase increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Blood bilirubin increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Lymphocyte count decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Blood thyroid stimulating hormone increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Blood lactate dehydrogenase increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Bilirubin conjugated increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Blood bilirubin unconjugated increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Electrocardiogram T wave abnormal **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Total bile acids increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Blood albumin decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Red blood cells urine positive **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Blood creatine phosphokinase MB increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Blood creatine phosphokinase increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Blood pressure increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Blood uric acid increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Fibrin D dimer increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Occult blood positive **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Urinary occult blood positive **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Alpha hydroxybutyrate dehydrogenase increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Blood creatinine increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Blood fibrinogen increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** C-reactive protein increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Interleukin level increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Mitochondrial aspartate aminotransferase increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Neutrophil count increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Tri-iodothyronine free decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** White blood cell count increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Protein urine present **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Red blood cell count decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations **Source Vocabulary:** **Term:** Decreased appetite **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** **Term:** Hypocalcaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** **Term:** Hyponatraemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** **Term:** Hypokalaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** **Term:** Hypoalbuminaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** **Term:** Hyperglycaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** **Term:** Hypertriglyceridaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** **Term:** Hypercholesterolaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** **Term:** Hypochloraemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** **Term:** Hypoproteinaemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders **Source Vocabulary:** **Term:** Arthralgia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** **Term:** Back pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** **Term:** Pain in extremity **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** **Term:** Musculoskeletal chest pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** **Term:** Headache **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Dizziness **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** **Term:** Insomnia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** **Term:** Proteinuria **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** **Term:** Haematuria **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** **Term:** Cough **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** **Term:** Laryngeal pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** **Term:** Dyspnoea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** **Term:** Pleural effusion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** **Term:** Productive cough **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** **Term:** Haemoptysis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** **Term:** Rash **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** **Term:** Palmar-plantar erythrodysaesthesia syndrome **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** **Term:** Pruritus **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** **Term:** Alopecia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** **Term:** Blister **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** **Term:** Pigmentation disorder **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** **Term:** Hypertension **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** **Term:** Hypotension **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** #### Serious Events **Term:** Drug-induced liver injury **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** Liver injury **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** Immune-mediated hepatitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Hepatobiliary disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** Alanine aminotransferase increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations ##### Stats **Group ID:** EG000 **Num Affected:** 5 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** Aspartate aminotransferase increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** Gamma-glutamyltransferase increased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** White blood cell count decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations ##### Stats **Group ID:** EG000 **Num At Risk:** 50 **Group ID:** EG001 **Num Affected:** 5 **Num At Risk:** 47 **Term:** Lymphocyte count decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations ##### Stats **Group ID:** EG000 **Num At Risk:** 50 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 47 **Term:** Platelet count decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations ##### Stats **Group ID:** EG000 **Num At Risk:** 50 **Group ID:** EG001 **Num Affected:** 4 **Num At Risk:** 47 **Term:** Neutrophil count decreased **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Investigations ##### Stats **Group ID:** EG000 **Num At Risk:** 50 **Group ID:** EG001 **Num Affected:** 5 **Num At Risk:** 47 **Term:** Pyrexia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders ##### Stats **Group ID:** EG000 **Num Affected:** 3 **Num At Risk:** 50 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 47 **Term:** Impaired healing **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** Hernia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** General disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** Infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** Pneumonia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** Septic shock **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** Wound infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** Urinary tract infection **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations ##### Stats **Group ID:** EG000 **Num At Risk:** 50 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 47 **Term:** Intestinal obstruction **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 50 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 47 **Term:** Diarrhea **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** Immune-mediated enterocolitis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** Vomiting **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** Gastrointestinal disorders **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** Pathological fracture **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** Cancer pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** Neoplasm progression **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 50 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 47 **Term:** Tumor lysis syndrome **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Metabolism and nutrition disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** Cerebral infarction **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** Pneumothorax **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** Hemoptysis **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 50 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 47 **Term:** Pleural effusion **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 50 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 47 **Term:** Cytokine release syndrome **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Immune system disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** Hypothyroidism **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Endocrine disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** Nephrotic syndrome **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** Cor Pulmonale **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** Degenerative aortic valve disease **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** Hypotension **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** Immune thrombocytopenia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 50 **Group ID:** EG001 **Num At Risk:** 47 **Term:** Anemia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 50 **Group ID:** EG001 **Num Affected:** 6 **Num At Risk:** 47 **Term:** Febrile neutropenia **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 50 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 47 **Term:** Myelosuppression **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders ##### Stats **Group ID:** EG000 **Num At Risk:** 50 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 47 **Time Frame:** 18 months ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 50 **Group ID:** BG001 **Value:** 47 **Group ID:** BG002 **Value:** 97 **Units:** Participants ### Group **ID:** BG000 **Title:** SHR-1210 Plus Apatinib **Description:** SHR-1210 200 mg q3w+ Apatinib 500 mg qd ### Group **ID:** BG001 **Title:** ADM Plus IFO or IFO Alone **Description:** ADM 60 mg/m2 D1 + IFO 2 g/m2 D1-D4 q3w；if the cumulative doses of ADM were beyond 450 mg/m2, the monotherapy of IFO (2 g/m2 D1-D5 q3w) would be used. ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 1 **Category Title:** <=18 years #### Measurement **Group ID:** BG000 **Value:** 49 #### Measurement **Group ID:** BG001 **Value:** 41 #### Measurement **Group ID:** BG002 **Value:** 90 **Category Title:** Between 18 and 65 years #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 5 #### Measurement **Group ID:** BG002 **Value:** 6 **Category Title:** >=65 years **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 20 #### Measurement **Group ID:** BG001 **Value:** 20 #### Measurement **Group ID:** BG002 **Value:** 40 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 30 #### Measurement **Group ID:** BG001 **Value:** 27 #### Measurement **Group ID:** BG002 **Value:** 57 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 50 #### Measurement **Group ID:** BG001 **Value:** 47 #### Measurement **Group ID:** BG002 **Value:** 97 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 50 #### Measurement **Group ID:** BG001 **Value:** 47 #### Measurement **Group ID:** BG002 **Value:** 97 **Class Title:** China **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Categorical **Unit of Measure:** Participants ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ## Results Section - More Information Module ### Certain Agreement **Other Details:** All clinical study findings and documents will be regarded as confidential. The investigator and members of his/her research team must not disclose such information without prior written approval from the sponsor. **Restriction Type:** OTHER **Restrictive Agreement:** True ### Point of Contact **Email:** [email protected] **Organization:** Jiangsu HengRui Pharmaceuticals Co., Ltd. **Phone:** +86-18036618962 **Title:** Project manager ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 4.1 - **Spread:** - **Upper Limit:** 6.9 - **Value:** 5.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 3.5 - **Spread:** - **Upper Limit:** 8.4 - **Value:** 5.5 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 11 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Randomization to Radiographic Progression or Death Due to Any Cause (Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions) **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 31 months, CT was conducted at baseline、weeks 7、13、19 and then every 12 weeks. **Title:** Progression Free Survival (PFS) **Type:** PRIMARY **Unit of Measure:** months ##### Group **Description:** SHR-1210 200 mg q3w+ Apatinib 500 mg qd **ID:** OG000 **Title:** SHR-1210 Plus Apatinib ##### Group **Description:** ADM 60 mg/m2 D1 + IFO 2 g/m2 D1-D4 q3w；if the cumulative doses of ADM were beyond 450 mg/m2, the monotherapy of IFO (2 g/m2 D1-D5 q3w) would be used. **ID:** OG001 **Title:** ADM Plus IFO or IFO Alone #### Outcome Measure 2 **Description:** Baseline to documented disease Remission to study discontinuation, Partial Remission is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 30% decrease in the sum of the beaseline diameter of target lesions. **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** From date of randomization until the date of study completion, an average of 1 year, CT was conducted at baseline、weeks 7、13、19 and then every 12 weeks. **Title:** Objective Response Rate (ORR) **Type:** SECONDARY **Unit of Measure:** participants ##### Group **Description:** SHR-1210 200 mg q3w+ Apatinib 500 mg qd **ID:** OG000 **Title:** SHR-1210 Plus Apatinib ##### Group **Description:** ADM 60 mg/m2 D1 + IFO 2 g/m2 D1-D4 q3w；if the cumulative doses of ADM were beyond 450 mg/m2, the monotherapy of IFO (2 g/m2 D1-D5 q3w) would be used. **ID:** OG001 **Title:** ADM Plus IFO or IFO Alone ### Participant Flow Module #### Group **Description:** SHR-1210 200 mg q3w+ Apatinib 500 mg qd **ID:** FG000 **Title:** SHR-1210 Plus Apatinib #### Group **Description:** ADM 60 mg/m2 D1 + IFO 2 g/m2 D1-D4 q3w；if the cumulative doses of ADM were beyond 450 mg/m2, the monotherapy of IFO (2 g/m2 D1-D5 q3w) would be used. **ID:** FG001 **Title:** ADM Plus IFO or IFO Alone #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 51 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 48 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 50 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 47 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 1 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 1 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT01263379 **Brief Title:** Gene Transfer for Recessive Dystrophic Epidermolysis Bullosa **Official Title:** A Phase 1/2A Single Center Trial of Gene Transfer for Recessive Dystrophic Epidermolysis Bullosa (RDEB) Using the Drug LZRSE-Col7A1 Engineered Autologous Epidermal Sheets (LEAES) #### Organization Study ID Info **ID:** SU-10202010-7130 #### Organization **Class:** INDUSTRY **Full Name:** Abeona Therapeutics, Inc #### Secondary ID Infos **ID:** R01AR055914 **Link:** https://reporter.nih.gov/quickSearch/R01AR055914 **Type:** NIH **Domain:** NIH Recombinant DNA Advisory Committee **ID:** RAC Protocol # 0701-827 **Type:** OTHER **Domain:** Stanford Institutional Review Board **ID:** eProtocol 14563 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2022-03-09 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-08-22 **Type:** ACTUAL **Last Update Submit Date:** 2023-08-04 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-03-09 **Type:** ACTUAL #### Results First Post Date **Date:** 2023-07-10 **Type:** ACTUAL **Results First Submit Date:** 2023-04-18 **Results First Submit QC Date:** 2023-06-19 #### Start Date **Date:** 2010-10-05 **Type:** ACTUAL **Status Verified Date:** 2023-08 #### Study First Post Date **Date:** 2010-12-20 **Type:** ESTIMATED **Study First Submit Date:** 2010-12-15 **Study First Submit QC Date:** 2010-12-17 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) **Class:** OTHER **Name:** Stanford University #### Lead Sponsor **Class:** INDUSTRY **Name:** Abeona Therapeutics, Inc #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This trial will create a skin graft, which the investigators call "LEAES," using the patient's own skin cells that have been genetically engineered in the lab to express a missing protein called type VII collagen. The corrected cells will be transplanted back to the patient. **Detailed Description:** The research project involves gene transfer into keratinocytes, which are the majority of the cells in the outer layer of skin. In this gene transfer trial we plan to biopsy some skin tissue, grow the cells in a skin cell culture (sterile dishes with special fluid that allows cells to grow and multiply) and then infect the cells with a virus that we have genetically engineered to insert the correct type VII collagen gene. The cells should then make type VII collagen. The process of inserting the correct type VII collagen gene into cells is called "gene transfer." The virus used is called a "retrovirus." The virus is made so that it only delivers the type VII collagen gene and it should not spread to other parts of the body. During the study we will check for growth of the virus. After cells have received gene transfer, we will grow the cells in culture into a sheet of cells that look like a plastic film. We plan to graft the sheet to wounds. Grafting means we will take cells from the culture and stitch them to the patient's skin. ### Conditions Module **Conditions:** - Epidermolysis Bullosa Dystrophica - Epidermolysis Bullosa **Keywords:** - gene transfer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 12 **Type:** ACTUAL **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** LZRSE-Col7A1 Engineered Autologous Epidermal Sheets (LEAES) **Intervention Names:** - Biological: LZRSE-Col7A1 Engineered Autologous Epidermal Sheets **Label:** LEAES treatment **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - LEAES treatment **Description:** This trial will create a graft, which we call "LEAES", of the patient's own skin that has been genetically engineered in our lab to express this missing protein. **Name:** LZRSE-Col7A1 Engineered Autologous Epidermal Sheets **Other Names:** - LEAES **Type:** BIOLOGICAL ### Outcomes Module #### Other Outcomes **Description:** Skin biopsies were obtained to observe physical development of the anchoring fibrils using electron microscopy **Measure:** Number of Participants With Presence of Anchoring Fibrils (AF) **Time Frame:** 3 months, 6 months, 12 months and 24 months post grafting #### Primary Outcomes **Description:** The graft site was clinically evaluated by the investigator with a global score of: 1) 100% to 75% healed, 2) 74% to 50% healed, 3) 49% or less healed with 100% meaning completely healed. **Measure:** Number of Wounds by Healing Category Per Investigator Visual Assessment **Time Frame:** 3, 6, 12 and 24 months post grafting **Description:** Percentage of wound area will be obtained using the Canfield system. Changes in dimensions between visits as well as changes in dimensions from baseline will be recorded. Dimensions of untreated wounded skin will be used for comparison **Measure:** Percentage Surface Area of Wound Healing **Time Frame:** 3, 6 and 12 months post grafting #### Secondary Outcomes **Description:** Skin biopsies were obtained to evaluate expression of type VII collagen, NC2 epitope, using immuno-electron microscopy and immuno-fluorescent light microscopy. **Measure:** Number Participants Positive for NC2 Epitope as a Measure of Duration of Type VII Collagen Production **Time Frame:** 3 months, 6 months, 12 months, 24 months post-grafting ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Clinical diagnosis of recessive dystrophic epidermolysis bullosa (RDEB) 2. 13 years old or older and willing and able to give assent/consent 3. Confirmation of RDEB diagnosis by immunofluorescence (IF) and electron microscopy (EM) 4. NC1\[+\] and mAb LH24 antibody staining negative 5. RDEB type VII collagen mutations in subject and carrier parents confirmed 6. At least 100 to 200 cm2 areas of open erosions on the trunk and/or extremities suitable for skin grafting 7. Able to undergo adequate anesthesia to allow grafting procedures to take place. Exclusion Criteria: 1. Medical instability limiting ability to travel to Stanford University Medical Center 2. The presence of medical illness expected to complicate participation and/or compromise the safety of this technique, such as active infection with HIV, hepatitis B or hepatitis C, as determined by hepatitis B surface antigen screening, detection of hepatitis C antibodies, or positive result of hepatitis C polymerase chain reaction (PCR) analysis. 3. Antibodies to type VII collagen associated antigens 4. Active infection in the area that will undergo grafting 5. Evidence of systemic infection 6. Current evidence or a history of squamous cell carcinoma in the area that will undergo grafting 7. Active drug or alcohol addiction 8. Hypersensitivity to vancomycin or amikacin 9. Receipt of chemical or biological study product for the specific treatment of RDEB in the past six months 10. Positive pregnancy test or breast-feeding 11. Clinically significant abnormalities (Grade 2 or higher on the National Cancer Institute \[NCI\] toxicity scale) on laboratory tests performed prior to grafting, except for the following specific exclusionary laboratory threshold results, subject to approval or exemption by the EB physician: * Albumin \< 2.5 g/dL * Leukocytes \> 20K/uL * Hemoglobin \< 7.5 g/dL. Low hemoglobin will be treated at the discretion of the investigators and the EB physician. * Additional exceptions may be made at the discretion of the investigators and the EB physician. 12. Clinically significant abnormalities (Grade 2 or higher on the NCI toxicity scale) identified through medical history and physical examination on Day 0, with the following exceptions: * Anorexia, can enroll up to Grade 4 (inclusive) * Constipation, can enroll up to Grade 2 (inclusive) * Dysphagia, can enroll up to Grade 4 (inclusive) * Keratitis, can enroll up to Grade 4 (inclusive) * Bone pain, can enroll up to Grade 2 (inclusive) * Additional exceptions may be made at the discretion of the investigators and the EB physician. **Minimum Age:** 13 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Redwood City **Country:** United States **Facility:** Stanford University, School of Medicine, Dept of Dermatology **State:** California **Zip:** 94063 #### Overall Officials **Official 1:** **Affiliation:** Stanford University **Name:** Jean Tang, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Results will be submitted to scientific journals for publication and presented at scientific meetings. **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES **Time Frame:** Study protocol is attached to this submission and will be available per ClinicalTrials.gov timeline. ### References Module #### References **Citation:** So JY, Nazaroff J, Iwummadu CV, Harris N, Gorell ES, Fulchand S, Bailey I, McCarthy D, Siprashvili Z, Marinkovich MP, Tang JY, Chiou AS. Long-term safety and efficacy of gene-corrected autologous keratinocyte grafts for recessive dystrophic epidermolysis bullosa. Orphanet J Rare Dis. 2022 Oct 17;17(1):377. doi: 10.1186/s13023-022-02546-9. **PMID:** 36253825 **Citation:** Eichstadt S, Barriga M, Ponakala A, Teng C, Nguyen NT, Siprashvili Z, Nazaroff J, Gorell ES, Chiou AS, Taylor L, Khuu P, Keene DR, Rieger K, Khosla RK, Furukawa LK, Lorenz HP, Marinkovich MP, Tang JY. Phase 1/2a clinical trial of gene-corrected autologous cell therapy for recessive dystrophic epidermolysis bullosa. JCI Insight. 2019 Oct 3;4(19):e130554. doi: 10.1172/jci.insight.130554. **PMID:** 31578311 **Citation:** Siprashvili Z, Nguyen NT, Gorell ES, Loutit K, Khuu P, Furukawa LK, Lorenz HP, Leung TH, Keene DR, Rieger KE, Khavari P, Lane AT, Tang JY, Marinkovich MP. Safety and Wound Outcomes Following Genetically Corrected Autologous Epidermal Grafts in Patients With Recessive Dystrophic Epidermolysis Bullosa. JAMA. 2016 Nov 1;316(17):1808-1817. doi: 10.1001/jama.2016.15588. **PMID:** 27802546 #### See Also Links **Label:** Stanford Dermatology Website: EB Research Update **URL:** http://dermatology.stanford.edu/gsdc/eb_clinic/trials/index.html **Label:** Safety and Wound Outcomes Following Genetically Corrected Autologous Epidermal Grafts in Patients With Recessive Dystrophic Epidermolysis Bullosa. **URL:** https://www.ncbi.nlm.nih.gov/pubmed/27802546 ## Document Section ### Large Document Module #### Large Docs - Date: 2017-05-13 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 628515 - Type Abbrev: Prot_SAP - Upload Date: 2023-06-19T15:05 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012868 - Term: Skin Abnormalities - ID: D000000013 - Term: Congenital Abnormalities - ID: D000012873 - Term: Skin Diseases, Genetic - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000012871 - Term: Skin Diseases - ID: D000012872 - Term: Skin Diseases, Vesiculobullous - ID: D000003095 - Term: Collagen Diseases - ID: D000003240 - Term: Connective Tissue Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M7976 - Name: Epidermolysis Bullosa - Relevance: HIGH - As Found: Epidermolysis Bullosa - ID: M18586 - Name: Epidermolysis Bullosa Dystrophica - Relevance: HIGH - As Found: Epidermolysis Bullosa Dystrophica - ID: M15672 - Name: Skin Abnormalities - Relevance: LOW - As Found: Unknown - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M15676 - Name: Skin Diseases, Genetic - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M15675 - Name: Skin Diseases, Vesiculobullous - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: T2098 - Name: Epidermolysis Bullosa - Relevance: HIGH - As Found: Epidermolysis Bullosa - ID: T1991 - Name: Dystrophic Epidermolysis Bullosa - Relevance: HIGH - As Found: Dystrophic Epidermolysis Bullosa - ID: T4889 - Name: Recessive Dystrophic Epidermolysis Bullosa - Relevance: HIGH - As Found: Recessive Dystrophic Epidermolysis Bullosa ### Condition Browse Module - Meshes - ID: D000004820 - Term: Epidermolysis Bullosa - ID: D000016108 - Term: Epidermolysis Bullosa Dystrophica ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** LEAES Treatment **Deaths Num At Risk:** 7 **Description:** LZRSE-Col7A1 Engineered Autologous Epidermal Sheets (LEAES) LZRSE-Col7A1 Engineered Autologous Epidermal Sheets: This trial will create a graft, which we call "LEAES", of the patient's own skin that has been genetically engineered in our lab to express this missing protein. **ID:** EG000 **Other Num Affected:** 7 **Other Num at Risk:** 7 **Serious Number Affected:** 2 **Serious Number At Risk:** 7 **Title:** LEAES Treatment **Frequency Threshold:** 0 #### Other Events **Term:** Wound infection **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** CTCAE (Unspecified) **Term:** Pruritus **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** CTCAE (Unspecified) **Term:** Pain **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** PAIN OF WOUND SITES **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** CTCAE (Unspecified) **Term:** Wound complication **Assessment Type:** SYSTEMATIC_ASSESSMENT **Notes:** Wound drainage **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** CTCAE (Unspecified) **Term:** Postoperative hemorrhage **Assessment Type:** SYSTEMATIC_ASSESSMENT **Organ System:** Surgical and medical procedures **Source Vocabulary:** CTCAE (Unspecified) #### Serious Events **Term:** Neoplasms benign, malignant and unspecified, squamous cell carcinoma **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** CTCAE (Unspecified) ##### Stats **Group ID:** EG000 **Num Affected:** 2 **Num At Risk:** 7 **Num Events:** 4 **Time Frame:** 2 years post receiving LEAES cell sheets ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 7 **Units:** Participants ### Group **ID:** BG000 **Title:** LEAES Treatment **Description:** LZRSE-Col7A1 Engineered Autologous Epidermal Sheets (LEAES) LZRSE-Col7A1 Engineered Autologous Epidermal Sheets: This trial will create a graft, which we call "LEAES", of the patient's own skin that has been genetically engineered in our lab to express this missing protein. ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** <=18 years #### Measurement **Group ID:** BG000 **Value:** 7 **Category Title:** Between 18 and 65 years #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** >=65 years **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 2 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 5 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 3 **Category Title:** Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 4 **Category Title:** Not Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 7 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 7 **Class Title:** United States **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Categorical **Unit of Measure:** Participants ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Ethnicity (NIH/OMB) **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ### Measure 5 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Region of Enrollment **Unit of Measure:** Participants ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** [email protected] **Organization:** Abeona Therapeutics **Phone:** (216) 282-8150 **Title:** Chief Medical Officer ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 35 **Title:** Global Score of 100% to 75% ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5 **Title:** Global Score of 74% to 50% ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 **Title:** Global Score of 49% or less **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 28 **Title:** Global Score of 100% to 75% ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3 **Title:** Global Score of 74% to 50% ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 11 **Title:** Global Score of 49% or less **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 19 **Title:** Global Score of 100% to 75% ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 11 **Title:** Global Score of 74% to 50% ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 12 **Title:** Global Score of 49% or less **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 26 **Title:** Global Score of 100% to 75% ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5 **Title:** Global Score of 74% to 50% ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 11 **Title:** Global Score of 49% or less #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 97.5 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 35 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 90 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 96 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 90.6 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 78.6 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 98 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 81.6 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 66.5 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 91.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 71 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 92 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 93.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 85.5 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 87.5 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 96 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 74.6 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 75.7 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 93.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 96 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 70 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 89.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 99 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 26 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 99 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 32 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - 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**Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 99 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 97 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 95 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 70 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 54 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 12 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 98.7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 81 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 48 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 55 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 44 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 82 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 73 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 29 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 84 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 10 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 70 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 48.8 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 31 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 92 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 85 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 79 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 74 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 78.56 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 82 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 78.67 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 100 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 98.7 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 92 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 76 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 78.6 **Title:** **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Participants **Denomination:** - **Group ID:** OG000 - **Value:** 1 - **Group ID:** OG001 - **Value:** 1 - **Group ID:** OG002 - **Value:** 1 **Units:** Wounds #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 7 **Title:** Positive for NC2 ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** Negative for NC2 ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** Not done **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5 **Title:** Positive for NC2 ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 **Title:** Negative for NC2 ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** Not done **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 **Title:** Positive for NC2 ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4 **Title:** Negative for NC2 ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** Not done **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 **Title:** Positive for NC2 ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** Negative for NC2 ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4 **Title:** Not done #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 6 **Title:** Positive for AFs ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** Negative for AFs ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** Not done **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5 **Title:** Positive for AFs ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 **Title:** Negative for AFs ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0 **Title:** Not done **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3 **Title:** Positive for AFs ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3 **Title:** Negative for AFs ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** Not done **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** Positive for AFs ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 **Title:** Negative for AFs ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5 **Title:** Not done ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** The graft site was clinically evaluated by the investigator with a global score of: 1) 100% to 75% healed, 2) 74% to 50% healed, 3) 49% or less healed with 100% meaning completely healed. **Parameter Type:** COUNT_OF_UNITS **Population Description:** The 7 participants who were determined to be eligible to receive LEAES cell sheets received 6 cell sheets to 6 wounds, each which were analyzed in this study as the primary endpoint. **Reporting Status:** POSTED **Time Frame:** 3, 6, 12 and 24 months post grafting **Title:** Number of Wounds by Healing Category Per Investigator Visual Assessment **Type:** PRIMARY **Type Units Analyzed:** wounds **Unit of Measure:** wounds ##### Group **Description:** LZRSE-Col7A1 Engineered Autologous Epidermal Sheets (LEAES) LZRSE-Col7A1 Engineered Autologous Epidermal Sheets: This trial will create a graft, which we call "LEAES", of the patient's own skin that has been genetically engineered in our lab to express this missing protein. **ID:** OG000 **Title:** LEAES Treatment #### Outcome Measure 2 **Description:** Percentage of wound area will be obtained using the Canfield system. Changes in dimensions between visits as well as changes in dimensions from baseline will be recorded. Dimensions of untreated wounded skin will be used for comparison **Parameter Type:** NUMBER **Population Description:** The Canfield Imaging System was implemented after the first 2 participants received LEAES. Tattoos were not used when placing tattoos for these first 2 participants. Therefore, measurements using the Canfield Imaging System was not possible. **Reporting Status:** POSTED **Time Frame:** 3, 6 and 12 months post grafting **Title:** Percentage Surface Area of Wound Healing **Type:** PRIMARY **Type Units Analyzed:** Wounds **Unit of Measure:** percentage of wound area ##### Group **Description:** LZRSE-Col7A1 Engineered Autologous Epidermal Sheets (LEAES) LZRSE-Col7A1 Engineered Autologous Epidermal Sheets: This trial will create a graft, which we call "LEAES", of the patient's own skin that has been genetically engineered in our lab to express this missing protein. **ID:** OG000 **Title:** 3 Months Post LEAES Treatment ##### Group **Description:** LZRSE-Col7A1 Engineered Autologous Epidermal Sheets (LEAES) **ID:** OG001 **Title:** 6 Months Post LEAES Treatment ##### Group **Description:** LZRSE-Col7A1 Engineered Autologous Epidermal Sheets (LEAES) **ID:** OG002 **Title:** 12 Months Post LEAES Treatment #### Outcome Measure 3 **Description:** Skin biopsies were obtained to evaluate expression of type VII collagen, NC2 epitope, using immuno-electron microscopy and immuno-fluorescent light microscopy. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** The 7 participants who were determined to be eligible to receive LEAES cell sheets received 6 cell sheets to 6 wounds, each which were analyzed in this study as the primary endpoint. **Reporting Status:** POSTED **Time Frame:** 3 months, 6 months, 12 months, 24 months post-grafting **Title:** Number Participants Positive for NC2 Epitope as a Measure of Duration of Type VII Collagen Production **Type:** SECONDARY **Unit of Measure:** Participants ##### Group **Description:** LZRSE-Col7A1 Engineered Autologous Epidermal Sheets (LEAES) LZRSE-Col7A1 Engineered Autologous Epidermal Sheets: This trial will create a graft, which we call "LEAES", of the patient's own skin that has been genetically engineered in our lab to express this missing protein. **ID:** OG000 **Title:** LEAES Treatment #### Outcome Measure 4 **Description:** Skin biopsies were obtained to observe physical development of the anchoring fibrils using electron microscopy **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** The 7 participants who were determined to be eligible to receive LEAES cell sheets received 6 cell sheets to 6 wounds, each which were analyzed in this study as the primary endpoint. **Reporting Status:** POSTED **Time Frame:** 3 months, 6 months, 12 months and 24 months post grafting **Title:** Number of Participants With Presence of Anchoring Fibrils (AF) **Type:** OTHER_PRE_SPECIFIED **Unit of Measure:** Participants ##### Group **Description:** LZRSE-Col7A1 Engineered Autologous Epidermal Sheets (LEAES) LZRSE-Col7A1 Engineered Autologous Epidermal Sheets: This trial will create a graft, which we call "LEAES", of the patient's own skin that has been genetically engineered in our lab to express this missing protein. **ID:** OG000 **Title:** LEAES Treatment ### Participant Flow Module #### Group **Description:** LZRSE-Col7A1 Engineered Autologous Epidermal Sheets (LEAES) LZRSE-Col7A1 Engineered Autologous Epidermal Sheets: This trial will create a graft, which we call "LEAES", of the patient's own skin that has been genetically engineered in our lab to express this missing protein. **ID:** FG000 **Title:** LEAES Treatment #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 7 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 7 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 **Pre-Assignment Details:** 12 participants signed informed consent, 7 were allocated to the treatment arm. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT00830479 **Acronym:** STRETCH **Brief Title:** Study of Endoscopic Versus Open Surgery for Urinary Reflux **Official Title:** A Randomized Trial of Endoscopic vs. Open Anti-Reflux Surgery For Treatment of Low-Grade Vesicoureteral Reflux: Surgical Treatment of Reflux: Endoscopic vs. Traditional CHoices (STRETCH) Study #### Organization Study ID Info **ID:** 08-08-0354 #### Organization **Class:** OTHER **Full Name:** Boston Children's Hospital ### Status Module #### Completion Date **Date:** 2011-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2011-08-12 **Type:** ESTIMATED **Last Update Submit Date:** 2011-08-11 **Overall Status:** WITHDRAWN #### Primary Completion Date **Date:** 2011-01 **Type:** ACTUAL #### Start Date **Date:** 2009-01 **Status Verified Date:** 2011-08 #### Study First Post Date **Date:** 2009-01-28 **Type:** ESTIMATED **Study First Submit Date:** 2009-01-27 **Study First Submit QC Date:** 2009-01-27 **Why Stopped:** unable to enroll patients for randomization ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Boston Children's Hospital #### Responsible Party **Old Name Title:** Caleb Nelson, MD, MPH / PI **Old Organization:** Children's Hospital Boston ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study seeks to compare outcomes after anti-reflux surgery (ARS) for correction of low-grade vesicoureteral reflux (VUR). It is a randomized controlled open-label trial of conventional open anti-reflux technique versus endoscopic anti-reflux technique with injection of dextranomer/hyaluronic acid copolymer (Deflux). Primary endpoint will be resolution of VUR at initial cystogram after ARS. Secondary outcomes will include incidence of postoperative UTI, resolution of VUR at 1-year cystogram after ARS, surgical complications, and quality of life measures after ARS. ### Conditions Module **Conditions:** - Vesicoureteral Reflux ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Procedure: Anti-reflux surgery **Label:** Open Surgery **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Procedure: Endoscopic injection **Label:** Endoscopic Surgery **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Open Surgery **Description:** Open ureteroneocystostomy for correction of vesicoureteral reflux **Name:** Anti-reflux surgery **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Endoscopic Surgery **Description:** Endoscopic injection of dextranomer/hyaluronic acid gel (Deflux) for correction of vesicoureteral reflux **Name:** Endoscopic injection **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Measure:** Resolution of VUR at 4 months **Time Frame:** 4 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age \<12 years * Unilateral or Bilateral Primary VUR * Grade 2 or 3 (VCUG) or Grade 2 (RNC) VUR in at least 1 ureter * Recommended for surgical correction of VUR by Urologist Exclusion Criteria: * Grade 4 or 5 (VCUG) or Grade 3 (RNC) VUR * Secondary VUR (neurogenic bladder, exstrophy, or other causes of secondary VUR) * Ureterocele * Periureteral diverticulum * Complete duplication of duplex collecting system on side with VUR * Prior ARS, either open or endoscopic, regardless of success or failure * History of other prior urinary tract surgery other than circumcision * Solitary functional kidney * Congenital or acquired immunodeficiency * Chronic renal insufficiency or renal failure **Maximum Age:** 11 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Boston **Country:** United States **Facility:** Children's Hospital Boston **State:** Massachusetts **Zip:** 02115 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000015154 - Term: Esophageal Motility Disorders - ID: D000003680 - Term: Deglutition Disorders - ID: D000004935 - Term: Esophageal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000001745 - Term: Urinary Bladder Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases ### Condition Browse Module - Browse Leaves - ID: M8880 - Name: Gastroesophageal Reflux - Relevance: HIGH - As Found: Reflux - ID: M17463 - Name: Vesico-Ureteral Reflux - Relevance: HIGH - As Found: Vesicoureteral Reflux - ID: M17874 - Name: Esophageal Motility Disorders - Relevance: LOW - As Found: Unknown - ID: M17875 - Name: Esophageal Spasm, Diffuse - Relevance: LOW - As Found: Unknown - ID: M6882 - Name: Deglutition Disorders - Relevance: LOW - As Found: Unknown - ID: M8085 - Name: Esophageal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M5026 - Name: Urinary Bladder Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005764 - Term: Gastroesophageal Reflux - ID: D000014718 - Term: Vesico-Ureteral Reflux ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M9878 - Name: Hyaluronic Acid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00708279 **Acronym:** SOMMA **Brief Title:** Study of Osteopathic Manipulation in the Management of Angina **Official Title:** Study of Osteopathic Manipulation in the Management of Angina #### Organization Study ID Info **ID:** F-07-04 SOMMA #### Organization **Class:** OTHER **Full Name:** University of New England #### Secondary ID Infos **Domain:** American Osteopathic Association - Osteopathic Heritage Fund **ID:** F-07-04 AOA/OHF Fellowship **Type:** OTHER ### Status Module #### Completion Date **Date:** 2008-07 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2011-04-14 **Type:** ESTIMATED **Last Update Submit Date:** 2011-04-13 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2008-04 **Type:** ACTUAL #### Start Date **Date:** 2007-08 **Status Verified Date:** 2010-06 #### Study First Post Date **Date:** 2008-07-02 **Type:** ESTIMATED **Study First Submit Date:** 2008-06-30 **Study First Submit QC Date:** 2008-07-01 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Osteopathic Heritage Foundations #### Lead Sponsor **Class:** OTHER **Name:** University of New England #### Responsible Party **Old Name Title:** Joy L. Palmer, D.O., Principal investigator **Old Organization:** Edward Via College of Osteopathic Medicine ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to assess the effectiveness of osteopathic manipulation in decreasing angina pectoris symptoms. ### Conditions Module **Conditions:** - Angina Pectoris **Keywords:** - angina pectoris, osteopathic manipulation ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 1 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** After establishing a baseline for the first 4 weeks of trial involvement, thereby providing their own control group, all participants begin the intervention phase of osteopathic manipulation. **Intervention Names:** - Procedure: Osteopathic manipulation **Label:** A **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - A **Description:** Participant will be evaluated and treated for somatic dysfunction utilizing osteopathic manipulation once a week for 3 weeks, then once every 3 weeks for three more visits; a total of 6 interventions in 3 months. **Name:** Osteopathic manipulation **Other Names:** - osteopathic manipulative medicine - structural exam - viscero-somatic reflexes - circulatory-respirtatory model - musculoskeletal model **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Measure:** Decrease in angina symptoms **Time Frame:** over 4 month period #### Secondary Outcomes **Measure:** Improvement in quality of life **Time Frame:** over 4 month period ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Canadian Cardiovascular Society Class II, III for a minimum of 6 months * documented coronary artery disease via previous myocardial infarction, abnormal stress test, or abnormal coronary angiogram of greater than or equal to 50% luminal obstruction of at least one epicardial vessel. Exclusion Criteria: * severe left ventricular dysfunction * symptomatic heart failure * symptomatic aortic stenosis or any valvular disease * significant pulmonary disease * unstable angina * major surgery or angioplasty in the past three months * acute myocardial infarction within past three months * insulin dependent diabetes mellitus * uncontrolled hypertension * acute renal or hepatic failure * currently being treated with osteopathic manipulation **Maximum Age:** 81 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Saco **Country:** United States **Facility:** University Health Care **State:** Maine **Zip:** 04072 #### Overall Officials **Official 1:** **Affiliation:** University of New England **Name:** Joy L. Palmer, D.O. **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000017202 - Term: Myocardial Ischemia - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002637 - Term: Chest Pain - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M4117 - Name: Angina Pectoris - Relevance: HIGH - As Found: Angina Pectoris - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M6546 - Name: Coronary Artery Disease - Relevance: LOW - As Found: Unknown - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M5882 - Name: Chest Pain - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000787 - Term: Angina Pectoris ### Misc Info Module - Version Holder: 2024-05-24