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## Protocol Section ### Identification Module **NCT ID:** NCT06427642 **Brief Title:** Efficacy Evaluation of UCB-MNCs in the Treatment of Refractory Neonatal Diseases **Official Title:** Efficacy Evaluation of Umbilical Cord Blood-derived Mononuclear Cells in the Treatment of Refractory Neonatal Diseases #### Organization Study ID Info **ID:** MNCs-2024 #### Organization **Class:** INDUSTRY **Full Name:** Shandong Qilu Stem Cells Engineering Co., Ltd. ### Status Module #### Completion Date **Date:** 2025-04-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2022-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Qilu Children's Hospital of Shandong University #### Lead Sponsor **Class:** INDUSTRY **Name:** Shandong Qilu Stem Cells Engineering Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Hypoxic-ischemic encephalopathy (HIE), bronchopulmonary dysplasia (BPD), short bowel syndrome (SBS) are refractory in clinical treatment. Thus, how to better prevent such diseases is currently a key research topic in the international field. The use of cord blood-derived mononuclear cells may promote to save lives and improve patient outcomes. ### Conditions Module **Conditions:** - Hypoxic-Ischemic Encephalopathy - Bronchopulmonary Dysplasia - Short Bowel Syndrome ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Intravenous infusion of UCB-MNCs is given within 24 hours of being identified as a high-risk patient **Intervention Names:** - Biological: Mononuclear cells - Device: Mild hypothermia therapy **Label:** Experimental group for children with HIE **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Mild hypothermia therapy is given for 72 hours to maintain anal temperature between 33.5°C and 34°C **Intervention Names:** - Device: Mild hypothermia therapy **Label:** Control group for children with HIE **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Intravenous infusion of UCB-MNCs is given within 24 hours of being identified as a high-risk patient **Intervention Names:** - Biological: Mononuclear cells - Device: Breathing support technique **Label:** Experimental group for children with BPD **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Clinical routine treatment **Intervention Names:** - Device: Breathing support technique **Label:** Control group for children with BPD **Type:** ACTIVE_COMPARATOR #### Arm Group 5 **Description:** Intravenous infusion of UCB-MNCs **Intervention Names:** - Biological: Mononuclear cells - Procedure: Total parenteral nutrition **Label:** Experimental group for children with SBS **Type:** EXPERIMENTAL #### Arm Group 6 **Description:** Clinical routine treatment **Intervention Names:** - Procedure: Total parenteral nutrition **Label:** Control group for children with SBS **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental group for children with BPD - Experimental group for children with HIE - Experimental group for children with SBS **Description:** UCB-MNCs are obtained from umbilical cord blood by density gradient centrifugation **Name:** Mononuclear cells **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Control group for children with HIE - Experimental group for children with HIE **Description:** Mild hypothermia therapy via hypothermia therapy apparatus **Name:** Mild hypothermia therapy **Type:** DEVICE #### Intervention 3 **Arm Group Labels:** - Control group for children with BPD - Experimental group for children with BPD **Description:** Breathing support via ventilator **Name:** Breathing support technique **Type:** DEVICE #### Intervention 4 **Arm Group Labels:** - Control group for children with SBS - Experimental group for children with SBS **Description:** Liquid nutrition injected directly into the bloodstream **Name:** Total parenteral nutrition **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Monitor oxygen, heart rate, temperature, rash, infection, etc **Measure:** Incidence of adverse reactions **Time Frame:** Within 12 hours after UCB-MNCs infusion #### Secondary Outcomes **Description:** Children with BPD: The incidence of various complications such as pneumothorax, necrotizing enterocolitis (NEC), intraventricular hemorrhage (grade 3 and above), persistent pulmonary hypertension (PPHN), retinopathy of prematurity (ROP) **Measure:** Incidence of complications **Time Frame:** a year **Description:** Children with HIE: Brain diffusion tensor imaging (DTI) and 18F-Fluorodeoxyglucose positron emission tomography (18F-FDG-PET/CT) **Measure:** Imaging test results **Time Frame:** 2 weeks and 6 months after UCB-MNCs infusion **Description:** Children with HIE: The frequency of seizures will be measured via EEG. Seizures appear on EEG as a sudden and transient rise in the lower and/or upper borders of amplitude **Measure:** Electroencephalography (EEG) results **Time Frame:** 7 days UCB-MNCs infusion **Description:** Ventilator supporting time and oxygen demand will be recorded as important indications for clinical prognosis for children with HIE or BPD **Measure:** Ventilator supporting time **Time Frame:** 1 month after UCB-MNCs infusion **Description:** GMPM is a standardized measurement tool for assessing quality of movement for children with HIE. Higher value means better motor quality **Measure:** Change of Gross Motor Performance Measure (GMPM) **Time Frame:** 1, 3, 6 months after UCB-MNCs infusion **Description:** GMFM is a standardized measurement tool for assessing motor function for children with HIE. It consists of lying \& rolling, sitting, crawling \& kneeling, standing, etc. Higher value means better gross motor function **Measure:** Change of Gross Motor Function Measure (GMFM) **Time Frame:** 1, 3, 6 months after UCB-MNCs infusion **Description:** pNF-H, marker of central nervous system axonal damage **Measure:** Biomarker of HIE **Time Frame:** 7 days after UCB-MNCs infusion **Description:** AGER, marker of lung epithelial cell damage **Measure:** Biomarker of BPD **Time Frame:** 7 days after UCB-MNCs infusion **Description:** Serum IL-6, IL-8, TNF concentrations will be measured via ELISA for children with HIE, BPD or SBS **Measure:** Inflammatory indicators concentrations **Time Frame:** 7 days after UCB-MNCs infusion ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * For children with hypoxic-ischemic encephalopathy (HIE): meet the diagnostic criteria for HIE. For children with bronchopulmonary dysplasia (BPD): 1) preterm infants with definite gestational age of 25-30 weeks; 2) birth weight 401-1249 g; 3) the risk of BPD was assessed to be greater than 60%. The scoring was based on the BPD high risk scoring system established by the NCHD Neonatal Cooperative Network; 4)parents read the subject's instructions, agreed to the treatment and signed the informed consent. For children with short bowel syndrome (SBS): 1) postoperative short bowel syndrome caused by neonatal necrotizing enterocolitis and other causes (developmental malformations of the digestive tract: intestinal atresia, anal atresia, intestinal stenosis, etc.); 2) parents read the subject's instructions, agreed to the treatment and signed the informed consent. Exclusion Criteria: * For children with HIE: unable or unwilling to provide informed consent or unable to comply with trial requirements. For children with BPD: 1) with severe anemia, severe intracranial hemorrhage, pulmonary hemorrhage, congenital respiratory malformations (posterior nostril atresia, tracheoesophageal fistula, cleft palate, etc.), complicated congenital heart disease, diaphragmatic hernia, shock, other serious comorbidities or complications (congenital inherited metabolic diseases, endocrine diseases, severe congenital malformations and other diseases that affect lung development); 2) unable or unwilling to provide informed consent or unable to comply with trial requirements. For children with SBS: unable or unwilling to provide informed consent or unable to comply with trial requirements. **Maximum Age:** 28 Days **Minimum Age:** 1 Day **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yujie Han, MD **Phone:** +86 187 5414 6336 **Role:** CONTACT #### Locations **Location 1:** **City:** Jinan **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Xiaoying Li - **Role:** CONTACT **Country:** China **Facility:** Qilu Children's Hospital of Shandong University **State:** Shandong **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Qilu Children's Hospital of Shandong University **Name:** Xiaoying Li, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000055397 - Term: Ventilator-Induced Lung Injury - ID: D000055370 - Term: Lung Injury - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000007235 - Term: Infant, Premature, Diseases - ID: D000002561 - Term: Cerebrovascular Disorders - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000002534 - Term: Hypoxia, Brain - ID: D000000860 - Term: Hypoxia - ID: D000012818 - Term: Signs and Symptoms, Respiratory - ID: D000008286 - Term: Malabsorption Syndromes - ID: D000007410 - Term: Intestinal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5794 - Name: Brain Ischemia - Relevance: HIGH - As Found: Ischemic Encephalopathy - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M4185 - Name: Hypoxia - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M5273 - Name: Bronchopulmonary Dysplasia - Relevance: HIGH - As Found: Bronchopulmonary Dysplasia - ID: M15586 - Name: Short Bowel Syndrome - Relevance: HIGH - As Found: Short Bowel Syndrome - ID: M10276 - Name: Infant, Newborn, Diseases - Relevance: HIGH - As Found: Neonatal Disease - ID: M5204 - Name: Brain Diseases - Relevance: HIGH - As Found: Encephalopathy - ID: M22660 - Name: Hypoxia-Ischemia, Brain - Relevance: HIGH - As Found: Hypoxic Ischemic Encephalopathy - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M28143 - Name: Lung Injury - Relevance: LOW - As Found: Unknown - ID: M28152 - Name: Ventilator-Induced Lung Injury - 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: M25869 - Name: Premature Birth - Relevance: LOW - As Found: Unknown - ID: M10279 - Name: Infant, Premature, Diseases - Relevance: LOW - As Found: Unknown - ID: M5810 - Name: Cerebrovascular Disorders - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M5783 - Name: Hypoxia, Brain - Relevance: LOW - As Found: Unknown - ID: M15623 - Name: Signs and Symptoms, Respiratory - Relevance: LOW - As Found: Unknown - ID: M11278 - Name: Malabsorption Syndromes - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: T874 - Name: Bronchopulmonary Dysplasia - Relevance: HIGH - As Found: Bronchopulmonary Dysplasia - ID: T5206 - Name: Short Bowel Syndrome - Relevance: HIGH - As Found: Short Bowel Syndrome ### Condition Browse Module - Meshes - ID: D000012778 - Term: Short Bowel Syndrome - ID: D000001997 - Term: Bronchopulmonary Dysplasia - ID: D000001927 - Term: Brain Diseases - ID: D000002545 - Term: Brain Ischemia - ID: D000020925 - Term: Hypoxia-Ischemia, Brain - ID: D000007232 - Term: Infant, Newborn, Diseases ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M4854 - Name: Benzocaine - Relevance: LOW - As Found: Unknown - ID: T433 - Name: Tannic Acid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427629 **Brief Title:** Investigator-initiated Clinical Trial to Observe Conjunctival Goblet Cell Using an Anterior Segment Imaging Device **Official Title:** Investigator-initiated Exploratory Clinical Trial to Observe Conjunctival Goblet Cell Density Using an Anterior Segment Imaging Device in Patients With Ocular Surface Disease (ODS) and Patients Scheduled for Ocular Surgery Without OSD #### Organization Study ID Info **ID:** 2311-108-1485 #### Organization **Class:** OTHER **Full Name:** Seoul National University Hospital ### Status Module #### Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-02 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Seoul National University Hospital #### Responsible Party **Investigator Affiliation:** Seoul National University Hospital **Investigator Full Name:** Chang Ho Yoon **Investigator Title:** Clinical associate professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Conjunctival goblet cells secrete mucin, vital for tear film stability. Dysfunction can cause tear film issues and lead to diseases like dry eye. Imaging these cells is crucial for diagnosis and treatment. 0.5% moxifloxacin eye drops, an FDA-approved antibiotic, are used to treat bacterial eye infections and prevent infections before surgeries. The investigators developed a non-invasive imaging method for goblet cells, validated in animals, and now plan to test it in humans for diagnosing and treating ocular surface diseases. **Detailed Description:** Conjunctival goblet cells secrete mucin on the ocular surface, playing a role in forming the mucin layer of the tear film. The mucin layer is crucial for maintaining tear film stability, and dysfunction of conjunctival goblet cells can lead to instability of the mucin layer, causing problems in the tear film. Because various ocular surface diseases stem from tear film instability, imaging of conjunctival goblet cells is essential for diagnosing and treating conditions such as dry eye. 0.5% moxifloxacin eye drops are FDA-approved antibiotics belonging to the quinolone class, widely used to treat bacterial infections in various ocular diseases. Clinically, 0.5% moxifloxacin eye drops are commonly used for purposes such as secondary infection prevention in cases of corneal epithelial defects or perforations caused by ocular surface diseases, as well as for prophylaxis prior to various ophthalmic surgeries, including cataract surgery. The investigators have previously pioneered non-invasive, high-speed, high-contrast imaging of conjunctival goblet cells. Previous studies have validated the performance and safety of this method by imaging conjunctival goblet cells in mice and rabbit animal models after the instillation of moxifloxacin and illuminating with a 405nm light source using confocal fluorescence microscopy. Furthermore, in this study, the investigators plan to conduct a study involving human subjects to apply our developed conjunctival goblet cell imaging technique for the diagnosis and evaluation of treatment outcomes in ocular surface diseases. ### Conditions Module **Conditions:** - Ocular Surface Disease ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 148 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients diagnosed with dry eye disease, sjogren syndrome, stevens-johnson syndrome, ocular graft versus host disease. **Intervention Names:** - Device: Imaging of conjunctival goblet cell **Label:** Patients with ocular surface disease **Type:** OTHER #### Arm Group 2 **Description:** Patients without ocular surface disease and scheduled for cataract surgery which requires moxifloxacin administration **Intervention Names:** - Device: Imaging of conjunctival goblet cell **Label:** Patients scheduled for ocular surgery without ocular surface disease **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients scheduled for ocular surgery without ocular surface disease - Patients with ocular surface disease **Description:** After instillation of moxifloxacin and illuminating with a 405nm light source using confocal fluorescence microscopy, conjunctival goblet cell imaging will be performed in patients with ocular surface disease and patients scheduled for ocular surgery without ocular surface disease **Name:** Imaging of conjunctival goblet cell **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Severity of dry eye will be assessed based on tear break up time and corneal punctate erosion score **Measure:** Association between conjunctival goblet cell density and severity of dry eye **Time Frame:** At the time of imaging #### Secondary Outcomes **Description:** Conjunctival punctate erosion score (NEI scale, 0-15), schirmer test (mm), matrix metalloproteinase 9 assay (negative/trace/positive/strong positive), ocular surface disease index (0-100 score) will be assessed as additional parameters. **Measure:** Difference of conjunctival goblet cell density according to disease and additional parameters related with ocular surface disease **Time Frame:** At the time of imaging ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult patients aged 19 years or older. * Patients who are currently using or scheduled to use 0.5% moxifloxacin eye drops for ophthalmic surgery (control group) or for ocular surface diseases (patient group: dry eye, Sjogren's syndrome, Stevens-Johnson syndrome, graft versus host disease). * Patients who have agreed to understand and comply with the clinical trial protocol's plans for medical examinations and follow-up observations. Exclusion Criteria: * Pregnant or planning to become pregnant, and lactating women. * Patients with intellectual disabilities and other psychiatric disorders who, at the discretion of the investigator, are deemed ineligible for participation in the clinical trial. * Patients with hypersensitivity reactions to 0.5% moxifloxacin eye drops, or patients for whom administration is contraindicated. * Patients for whom participation in the study is deemed impractical based on the judgment of other medical staff and neutral observers (excluding specified selection/exclusion criteria, based on medical reasons, ethical considerations, low compliance, and understanding of the study). **Healthy Volunteers:** True **Maximum Age:** 85 Years **Minimum Age:** 19 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Chang Ho Yoon, MD PhD **Phone:** 82220724309 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Seoul National University Hospital **Name:** Chang Ho Yoon, MD PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Repr - Name: Reproductive Control Agents ### Intervention Browse Module - Browse Leaves - ID: M1722 - Name: Moxifloxacin - Relevance: LOW - As Found: Unknown - ID: M266292 - Name: Norgestimate, ethinyl estradiol drug combination - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427616 **Brief Title:** Moderate Intensity Soleus Pushups Versus Sustained Soleus Pushups on Blood Glucose Level Among Young Population **Official Title:** Effects of Short Duration Moderate Intensity Soleus Pushups Versus Sustained Soleus Pushups on Blood Glucose Level Among Young Population #### Organization Study ID Info **ID:** 3547 Sara Noor #### Organization **Class:** OTHER **Full Name:** Riphah International University ### Status Module #### Completion Date **Date:** 2024-07-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-28 **Type:** ESTIMATED #### Start Date **Date:** 2023-10-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-19 ### 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:** To determine that the short duration moderate intensity soleus push-ups will have a better effect on blood glucose level as compared to sustained soleus push-ups. **Detailed Description:** The soleus muscle is a slow oxidative muscle which possesses molecular machinery necessary for regulating blood borne substrates. It has the ability to increase the local oxidative metabolism for a long period of time without experiencing fatigue. The uniqueness lies in this muscle because of its inability to store glycogen and derives its energy directly from the glucose present in the bloodstream. This in turn helps in lowering the blood sugar by using the excess blood glucose as its primary source of fuel. The soleus muscle also stands out because of its high composition of slow oxidative fibers, around 88% of the fibers are slow twitch fibers, making it the only muscle in human body containing greater proportion of slow twitch fiber. A specific exercise called soleus push-ups (SPU) can have a huge impact on boosting metabolism and regulating blood glucose level better than the total body muscle exercises, intermittent fasting, weight loss etc. According to the previous study it showed a significant effect on the overall blood chemistry when performed for 270 mins. So,the purpose of this study will be to find the comparison of acute effects of sustained soleus push-ups with moderate resisted soleus push-ups on blood sugar level. To find whether moderate resisted soleus push-ups will give same or better results in short period of time. ### Conditions Module **Conditions:** - Health Behavior ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 39 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Moderate intensity involving weighted soleus push-ups is performed till patient MHR is achieved. **Intervention Names:** - Behavioral: Short Duration Moderate Intensity Soleus Push-ups **Label:** Short Duration Moderate Intensity Soleus Push-ups (Group A) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Sustained soleus push-ups will be performed for up to 270 min. **Intervention Names:** - Behavioral: Sustained Soleus Push-ups **Label:** Sustained Soleus Push-ups (Group B) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Short Duration Moderate Intensity Soleus Push-ups (Group A) **Description:** Participants will start soleus push-ups in sitting positions. To do so, the participants will be in a seated position, the legs will be at 90 degrees to the floor, feet will be placed flat on the ground. Participants will then move their heels up and down continuously. Soleus push-ups will be performed with moderate intensity using weights which will be placed on their laps. Participants will perform this activity till their 60-80% of their maximum heart rate is achieved and maintained **Name:** Short Duration Moderate Intensity Soleus Push-ups **Other Names:** - Group A **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Sustained Soleus Push-ups (Group B) **Description:** Participants will start soleus push-ups in sitting. To do so, the participants will be in a seated position, the legs will be at 90 degrees to the floor, and feet will be placed flat on the ground. Participants will then move their heels up and down continuously for. Sustained soleus push-ups will be performed with light intensity for up to 270 mins. No external resistance will be added. Participants will be provided with a maximum of 4 min break time after every 90 mins intervention. In the meantime, their blood sample will be collected **Name:** Sustained Soleus Push-ups **Other Names:** - Group B **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** Adherence to the prescribed exercise will be monitored throughout the intervention period to assess compliance and determine if there are any differences in adherence between the two exercise groups. **Measure:** Adherence to Exercise Protocol **Time Frame:** Baseline to 6 hours #### Primary Outcomes **Description:** The primary outcome measure will be the change in blood sugar level, measured before and after the intervention period. This will provide insight into the direct impact of short duration moderate intensity soleus push-ups vs sustained soleus push-ups on blood sugar levels among young individuals. **Measure:** Change in Blood Sugar Level **Time Frame:** Baseline to 6 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age: 18-35 years. * Gender: both male and female. * Healthy young adults. * BMI: healthy weight. Exclusion Criteria: * Patient with cardiac issues. * Any neurological issues. * Knee injuries. * Patient with any lower limb injuries. * DVT and lower amputation. * Any known diabetic patient. **Healthy Volunteers:** True **Maximum Age:** 26 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Waqar Ahmed Awan, PHD **Phone:** 0333-534884 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Sara Noor, DPT **Phone:** 0306-1515493 **Role:** CONTACT #### Locations **Location 1:** **City:** Rawalpindi **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Waqar Ahmed Awan, PHD - **Phone:** 03335348846 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Sara Noor, Masters - **Phone:** 03061515493 - **Role:** CONTACT **Country:** Pakistan **Facility:** Railway General Hospital **State:** Punjab **Status:** RECRUITING **Zip:** 46120 #### Overall Officials **Official 1:** **Affiliation:** Riphah International University Islamabad **Name:** Waqar Ahmed Awan, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427603 **Brief Title:** Sit Less and Move More: Feasibility Study **Official Title:** Sit Less and Move More: A Feasibility Study on Physical Active Break Intervention and Improving Cardiometabolic Health #### Organization Study ID Info **ID:** RD/2022/2.12 #### Organization **Class:** OTHER **Full Name:** Hong Kong Metropolitan University ### Status Module #### Completion Date **Date:** 2025-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hong Kong Metropolitan University #### Responsible Party **Investigator Affiliation:** Hong Kong Metropolitan University **Investigator Full Name:** Dr Bonny WONG Yee Man **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Intervention aiming to improve cardiometabolic health by reducing prolonged sitting ### Conditions Module **Conditions:** - Sedentary Behavior ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: physical activity **Label:** activity group **Type:** EXPERIMENTAL #### Arm Group 2 **Label:** control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - activity group **Description:** workshops and mobile apps: break sedentary behavior by activity breaks **Name:** physical activity **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** will be assessed using a scale "Feasibility, appropriateness, and acceptability of the intervention" **Measure:** Intervention feasibility **Time Frame:** T2: post-intervention (week 12) #### Secondary Outcomes **Description:** will be assessed using an accelerometer **Measure:** Sedentary behavior **Time Frame:** T1: baseline (before the study begins) **Description:** will be assessed using an accelerometer **Measure:** Sedentary behavior **Time Frame:** T2: post-intervention (week 12) **Description:** will be assessed using the Strength, Assistance with walking, Rise from a chair, Climb stairs and (Calf) Falls (SARC-Calf) **Measure:** Sarcopenia score ranged from 0 to 20 **Time Frame:** T1: baseline (before the study begins) **Description:** will be assessed using the Strength, Assistance with walking, Rise from a chair, Climb stairs and (Calf) Falls (SARC-Calf) **Measure:** Sarcopenia score ranged from 0 to 20 **Time Frame:** T2: post-intervention (week 12) **Description:** will be assessed using a portable blood monitoring device **Measure:** Blood glucose **Time Frame:** T1: baseline (before the study begins) **Description:** will be assessed using a portable blood monitoring device **Measure:** Blood glucose **Time Frame:** T2: post-intervention (week 12) **Description:** will be assessed using a portable blood monitoring device **Measure:** Blood lipid **Time Frame:** T1: baseline (before the study begins) **Description:** will be assessed using a portable blood monitoring device **Measure:** Blood lipid **Time Frame:** T2: post-intervention (week 12) **Description:** will be assessed using a portable blood monitoring device **Measure:** Blood pressure **Time Frame:** T1: baseline (before the study begins) **Description:** will be assessed using a portable blood monitoring device **Measure:** Blood pressure **Time Frame:** T2: post-intervention (week 12) **Description:** will be assessed using a hand-held dynamometer **Measure:** Muscle strength (handgrip strength) **Time Frame:** T1: baseline (before the study begins) **Description:** will be assessed using a hand-held dynamometer **Measure:** Muscle strength (handgrip strength) **Time Frame:** T2: post-intervention (week 12) **Description:** will be assessed using Time-Up-to-Go (TUG) **Measure:** Physical performance **Time Frame:** T1: baseline (before the study begins) **Description:** will be assessed using Time-Up-to-Go (TUG) **Measure:** Physical performance **Time Frame:** T2: post-intervention (week 12) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. are community-dwelling older adults aged 65 years or above, 2. are smartphone users, 3. sit for \>= 6 hours per day 4. are overweight Exclusion Criteria: 1. are unable to walk independently with/without walking aids due to a physical disability; 2. have health conditions that hinder the adherence to intervention **Healthy Volunteers:** True **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Ho Man Tin **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Bonny YM Wong, PhD - **Phone:** (852) 3970 2976 - **Role:** CONTACT ***Contact 2:*** - **Name:** Bonny YM Wong, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Hong Kong **Facility:** School of Nursing and Health Studies, Hong Kong Metropolitan University ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427590 **Brief Title:** Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Healthy Subjects **Official Title:** A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 Injection for Subcutaneous Use in Healthy Subjects #### Organization Study ID Info **ID:** ASC47-101 #### Organization **Class:** INDUSTRY **Full Name:** Gannex Pharma Co., Ltd. ### Status Module #### Completion Date **Date:** 2025-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Gannex Pharma Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False ### Description Module **Brief Summary:** This will be a phase I, randomized, double-blind, placebo-controlled, single-dose escalation study. This study will be conducted in three periods: the screening period , the treatment period and the follow-up period. This study aims to evaluate the pharmacokinetics, target engagement and pharmacodynamic biomarkers of ASC47 in healthy subjects. **Detailed Description:** The study will consist of five cohorts, each with different doses of ASC47. Cohorts 1 and 2 have 6 subjects, of which 4 subjects will receive the single dose of ASC47 and 2 subjects will receive matching placebo. Cohorts 3, 4 and 5 have 8 subjects, of which 6 subjects will receive the single dose of ASC47 and 2 subjects will receive matching placebo. ### Conditions Module **Conditions:** - NASH **Keywords:** - ASC47 ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 4 subjects will receive the dose 1 of ASC47, and 2 subjects will receive the placebo. **Intervention Names:** - Drug: ASC47 - Drug: Matching placebo **Label:** cohort 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 4 subjects will receive the dose 2 of ASC47, and 2 subjects will receive the placebo. **Intervention Names:** - Drug: ASC47 - Drug: Matching placebo **Label:** cohort 2 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** 6 subjects will receive the dose 3 of ASC47, and 2 subjects will receive the placebo. **Intervention Names:** - Drug: ASC47 - Drug: Matching placebo **Label:** cohort 3 **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** 6 subjects will receive the dose 4 of ASC47, and 2 subjects will receive the placebo. **Intervention Names:** - Drug: ASC47 - Drug: Matching placebo **Label:** cohort 4 **Type:** EXPERIMENTAL #### Arm Group 5 **Description:** 6 subjects will receive the dose 5 of ASC47, and 2 subjects will receive the placebo **Intervention Names:** - Drug: ASC47 - Drug: Matching placebo **Label:** cohort 5 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - cohort 1 - cohort 2 - cohort 3 - cohort 4 - cohort 5 **Description:** single subcutaneous injection of ASC47 **Name:** ASC47 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - cohort 1 - cohort 2 - cohort 3 - cohort 4 - cohort 5 **Description:** single subcutaneous injection of Placebo **Name:** Matching placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) from after the first dose administration to 57 days. **Measure:** Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 **Time Frame:** up to 57 days **Description:** Evaluate the ECG QT Interval after single doses of ASC47. **Measure:** ECG QT Interval **Time Frame:** up to 57 days **Description:** Evaluate red blood cell count, white blood cell count and platelet count in liter (cells/L) after single doses of ASC47. **Measure:** Blood cell **Time Frame:** up to 57 days **Description:** Evaluate the levels of glucose, cholesterol, electrolytes after single doses of ASC47. **Measure:** Hematology **Time Frame:** up to 57 days #### Secondary Outcomes **Description:** Evaluate the Area under the plasma concentration versus time curve after single doses of ASC47. **Measure:** AUC of ASC47 **Time Frame:** up to 57 days **Description:** Evaluate the Peak Plasma Concentration after single doses of ASC47. **Measure:** Cmax of ASC47 **Time Frame:** up to 57 days **Description:** Evaluate the Minimum Plasma Concentration after single doses of ASC47. **Measure:** Cmin of ASC47 **Time Frame:** up to 57 days **Description:** Evaluate the Terminal-Phase Half-Life after single doses of ASC47 **Measure:** T1/2 of ASC47 **Time Frame:** up to 57 days **Description:** Evaluate the Apparent Systemic Clearance after single doses of ASC47. **Measure:** CL/F of ASC47 **Time Frame:** up to 57 days **Description:** Evaluate the Apparent Volume of Distribution after single doses of ASC47. **Measure:** Vd/F of ASC47 **Time Frame:** up to 57 days **Description:** Evaluate the LDL-C, TG, TC, HDL-C after single doses of ASC47. **Measure:** Lipid parameters **Time Frame:** up to 57 days ### Eligibility Module **Eligibility Criteria:** Key inclusion Criteria: * Subject have provided informed consent before initiation of any study-specific procedures * Healthy male subjects or female subjects, between 18 and 55 years of age (inclusive). * Females who are not pregnant or breastfeeding, or do not plan to become pregnant within 6 months and are willing to use effective contraceptive measures from the first dose of the investigational product until 3 months after the last dose are eligible. * In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures, eg. Key exclusion Criteria: * Have a clinically relevant acute or chronic medical condition or disease of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, or dermatologic systems as assessed by the investigator. * Have any current or historical disease or disorder of the hematological system or significant liver disease or family history of bleeding/platelet disorders. * Have a history of cancer (other than basal cell or squamous cell cancer of the skin which is fully excised), rheumatologic disease or blood dyscrasia. * Have a history of febrile illness within 14 days prior to screening. * Have a positive alcohol or drug screen at Screening or have a history of alcohol or drug abuse within the past 1 years. * Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised. * Have used prescription drugs (other than hormone replacement therapy and medications for contraceptive purpose) within 14 days prior to the first dose of Investigational product. **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427577 **Brief Title:** Study on the Mechanism of ZhenQiFuZheng in the Treatment of Allergic Rhinitis Based on Intestinal Flora and Metabolites **Official Title:** Study on the Mechanism of ZhenQiFuZheng in the Treatment of Allergic Rhinitis Based on Intestinal Flora and Metabolites #### Organization Study ID Info **ID:** 2024-SR-304 ZhenQiFuZheng #### Organization **Class:** OTHER **Full Name:** The First Affiliated Hospital with Nanjing Medical University ### Status Module #### Completion Date **Date:** 2028-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-04-26 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The First Affiliated Hospital with Nanjing Medical University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** ZhenQi FuZheng granules has been used to improve the immune function of human body, protect the bone marrow and adrenal cortex function and promote the recovery of positive function in traditional Chinese medicine care, especially with the immune imbalance diseases like post-surgery, chemotherapy and rhinitis. This project intends to establish AR（allergic rhinitis）specimen library, cell and animal model experiment, combining clinical cohort research with applied basic research, further assess the therapeutic mechanism of ZhenQiFuZheng granules in AR. We assume that ZhenQi FuZheng granules could cause the metabolic omics changes of nasal inflammatory factors and nasal secretions in AR patients, thus improving the type 2 inflammation level of allergic rhinitis. ### Conditions Module **Conditions:** - Rhinitis, Allergic ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** ZhenQi FuZheng granules (ShiDaiYangGuang) 1 bag at a time, twice a day. Oral for 4 weeks. **Intervention Names:** - Drug: ZhenQi FuZheng granules (ShiDaiYangGuang) **Label:** Allergic rhinitis **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Allergic rhinitis **Description:** 1 bag at a time, twice a day. Oral orally for 4 weeks. **Name:** ZhenQi FuZheng granules (ShiDaiYangGuang) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure **Measure:** Rhinoconjunctivitis Quality of Life Questionnaire **Time Frame:** 12 weeks **Description:** Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure **Measure:** Visual Analog Score for pain **Time Frame:** 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult patients (18-65 years). * Patients who visited the Department of Otolaryngology of the First Affiliated Hospital of Nanjing Medical University and are diagnosed as allergic rhinitis . Exclusion Criteria: * Patients who refused to accept specimen and questionnaire collection. * Patients who had nasal diseases other than allergic rhinitis, such as nasal papilloma and nasal malignant tumor. **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:** Lei Cheng **Phone:** +8613776620807 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Al-Digheari A, Mahboub B, Tarraf H, Yucel T, Annesi-Maesano I, Doble A, Lahlou A, Tariq L, Aziz F, El Hasnaoui A. The clinical burden of allergic rhinitis in five Middle Eastern countries: results of the SNAPSHOT program. Allergy Asthma Clin Immunol. 2018 Nov 19;14:63. doi: 10.1186/s13223-018-0298-x. eCollection 2018. **PMID:** 30473712 **Citation:** Eifan AO, Durham SR. Pathogenesis of rhinitis. Clin Exp Allergy. 2016 Sep;46(9):1139-51. doi: 10.1111/cea.12780. **PMID:** 27434218 **Citation:** Cheng L, Chen J, Fu Q, He S, Li H, Liu Z, Tan G, Tao Z, Wang D, Wen W, Xu R, Xu Y, Yang Q, Zhang C, Zhang G, Zhang R, Zhang Y, Zhou B, Zhu D, Chen L, Cui X, Deng Y, Guo Z, Huang Z, Huang Z, Li H, Li J, Li W, Li Y, Xi L, Lou H, Lu M, Ouyang Y, Shi W, Tao X, Tian H, Wang C, Wang M, Wang N, Wang X, Xie H, Yu S, Zhao R, Zheng M, Zhou H, Zhu L, Zhang L. Chinese Society of Allergy Guidelines for Diagnosis and Treatment of Allergic Rhinitis. Allergy Asthma Immunol Res. 2018 Jul;10(4):300-353. doi: 10.4168/aair.2018.10.4.300. **PMID:** 29949830 **Citation:** Wang XD, Zheng M, Lou HF, Wang CS, Zhang Y, Bo MY, Ge SQ, Zhang N, Zhang L, Bachert C. An increased prevalence of self-reported allergic rhinitis in major Chinese cities from 2005 to 2011. Allergy. 2016 Aug;71(8):1170-80. doi: 10.1111/all.12874. Epub 2016 Apr 13. **PMID:** 26948849 **Citation:** Li K, Chen Y, Jiang R, Chen D, Wang H, Xiong W, Li D, Liu Z, Li X, Li J, Yuan K. Protective effects of astragaloside IV against ovalbumin-induced allergic rhinitis are mediated by T-box protein expressed in T cells/GATA-3 and forkhead box protein 3/retinoic acid-related orphan nuclear receptor gammat. Mol Med Rep. 2017 Aug;16(2):1207-1215. doi: 10.3892/mmr.2017.6685. Epub 2017 Jun 6. **PMID:** 28586019 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000009668 - Term: Nose Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000010038 - Term: Otorhinolaryngologic Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### 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: BC20 - Name: Immune System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M15049 - Name: Rhinitis - Relevance: HIGH - As Found: Rhinitis - ID: M30545 - Name: Rhinitis, Allergic - Relevance: HIGH - As Found: Rhinitis, Allergic - 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: 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: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012220 - Term: Rhinitis - ID: D000065631 - Term: Rhinitis, Allergic ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427564 **Brief Title:** Vital Signs Collection Via "Comestai" App **Official Title:** Vital Signs Data Collection Using "Comestai" Application #### Organization Study ID Info **ID:** CET 98-2024 #### Organization **Class:** OTHER **Full Name:** Buzzi Children's Hospital ### Status Module #### Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Buzzi Children's Hospital #### Responsible Party **Investigator Affiliation:** Buzzi Children's Hospital **Investigator Full Name:** Valeria Calcaterra **Investigator Title:** Clinical 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 the study is to verify and validate the parameters collected from mobile devices via the app named "Comestai" and from reference devices. The assessments considered to define comorbidities are included.. Specifically, collection of vital parameters (Blood Pressure, Heart Rate, Respiratory Rate, Oxygen Saturation) through the "Comestai" Application via mobile phones (using photoplethysmographic method) and reference devices such as Withings-Blood Pressure Monitor Connect® (for Blood Pressure), Polar Verity Sense® (for Heart Rate), Masimo-finger sensor® (for Oxygen Saturation, Respiratory Rate), comparing and confirming them. Consent will be sought for the viewing and collection of blood test results that are normally included in evaluations for subjects with overweight and/or obesity and/or diabetes. Estimated time required for each measurement recording: 10-15 minutes per subject Total number of subjects: 3000 **Detailed Description:** Early detection of variations in vital parameters allows for the identification of changes in patients' health status and the provision of recommendations for therapeutic adjustments. The application named "Comestai" is a non-invasive and easy-to-use tool that enables the measurement of vital parameters. The app allows users to simultaneously measure vital parameters such as Heart Rate (HR), Respiratory Rate (RR), Oxygen Saturation (SpO2), and Blood Pressure (BP) using the photoplethysmographic method with the front camera of a mobile device. The use of simultaneous vital parameter measurement systems like apps can enhance self-monitoring of health status and improve patient care. In this study, vital parameters will be measured using the "Comestai" application and compared and validated with measurements from standard clinical practice devices. Consent will be sought for the viewing and collection of biochemical evaluation results typically required for individuals with overweight and/or obesity and/or diabetes. "Comestai" Application: This wellness app allows for non-invasive measurement of vital parameters, enabling users to detect SpO2, HR, RR, and BP by looking at the front camera of a mobile device ("By Face"). The measurement method used is Remote Photoplethysmography (rPPG). This is a prospective, open-label, study to collect vital parameters using the Comestai application by looking at the front camera of a mobile device ("By Face"). The measurement method of the app is Remote Photoplethysmography (rPPG). The study plans to enroll up to 3000 subjects Each subject will be assigned a specific identification number (Subject ID). During the evaluation, the following data will be recorded in the Electronic Case Report Form (eCRF): Medical history of the subject Current or past therapies Demographic data (date of birth, sex) Smoking habits Physical characteristics (height in meters, weight in kilograms, Body Mass Index in kg/m\^2, and phototype) During the 'By Face' measurement of vital parameters with the app, subjects will be asked to sit in a comfortable place, looking at the phone screen (about 25 cm away) with their face fully uncovered (no masks, hats, or any facial accessories). During data collection, the subject should remain still and breathe steadily. The subject will be required to look directly at the camera throughout the data collection process. The 'By Face' data collection mode can be performed on both iOS and Android in parallel, with both devices positioned in front of the subject. HR and blood pressure will also be measured immediately before and after the app measurement. Data Collection Equipment For vital signs data collection using the "Comestai" application, the study staff will use the following mobile phones for rPPG "By Face" measurements: * Face: Apple internet(i)Phone 13 Pro (10 bit) \& Samsung Galaxy S21 Ultra * Two additional phones will be used as remote: * One Android phone - Recorder Remote to start the measurement from far. * One Apple iPhone -Masimo-finger sensor App to collect the data from the Masimo finger sensor. * Other necessary equipment includes phone stands (two per room of measurement). In addition to the equipment for vital signs data collection using the "Comestai" application, reference devices will measure the subject's vital signs as a point of comparison. rPPG "By Face" vital signs data collection includes videoing the subjects' faces with a mobile device (iOS and Android) front camara for approximately 1.5 minutes. Vital signs data using the reference devices (i.e., SpO2, RR, BP, PR) will be collected continuously for approximately 1.5 minutes, and simultaneously to the data collected using the "Comestai" application (i.e., "By Face"). Several data collection events (1.5 minutes each) may be performed per subject using the "Comestai" application and reference devices. BP will be collected using the reference devices prior to data collection using the Comestai application and immediately after completion of data collection using the Comestai application. During "By Face" data collection, the subjects will be requested to sit in a comfortable place, looking at a screen (distance of \~25cm) with a fully exposed face (not to wear a mask, hat, or any kind of accessory on the face). During data collection, the subject breathing should be stable with minimum movements. The subject will be requested to stare directly towards the camara during the whole data collection process. "By Face" mode of data collection can be taken for both iOS and Android in parallel when both devices are positioned in front of the subject. During the "By Face" data collection, SpO2 levels will be monitored continuously using the standard reference device. Consent will be sought for viewing and collecting the results of pre-scheduled blood tests. Participation is optional, and subjects who do not consent can still proceed with the parameter measurements. In case of acceptance, the following results will be considered: Complete Blood Count (Hemoglobin, White Blood Cell Count, Neutrophils, Lymphocytes, and Platelets), Hemoglobin Glycosylated (HbA1C), Lipid Profile (Total Cholesterol, Cholesterol-LDL, Cholesterol-HDL, and Triglycerides), Glucose, Alanine transaminase (ALT), Creatinine. Estimated participation time per subject: approximately 10-15 minutes. No medical decisions will be based on data obtained through the "Comestai" application, reference devices, or blood sample results. All data will be recorded in the study's eCRF. The analysis plan involves verifying and validating the parameters collected from mobile devices via the app and from reference devices, as well as results of pre-scheduled blood tests and patient demographic data. For all parameters, the accuracy of the app measurement compared to the reference device and standard tests will be assessed. Confidence intervals will be calculated using the bootstrap method. The correlation between measurements using the app and those using reference devices and standard tests will be evaluated using the Pearson correlation coefficient. The agreement between the two measurements (app and reference devices/and standard tests) will be represented using Bland-Altman plots. ### Conditions Module **Conditions:** - Vital Signs ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 3000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Collect, verify and validate Pulse rate (beats per minute) in data using the Comestai application and reference devices. Pulse rate data obtained using the Comestai application and reference data will be stored on Comestai's secured cloud without any subject identifiable information and will only be recognized using the subject identification number provided during screening. The raw data of subjects' vital signs will be locked, encrypted, and can be read only by Study center team. The measurement method utilized by the app is Remote Photoplethysmography (rPPG). No medical decisions will be made based on the data obtained using the Comestai application, the reference devices, and the pre-scheduled blood sample results. **Measure:** Data Collection Storage and Processing-Pulse rate **Time Frame:** 15 minutes for data collection **Description:** Collect, verify and validate Oxygen saturation (percentage) in data using the Comestai application and reference devices. Oxygen saturation data obtained using the Comestai application and reference data will be stored on Comestai's secured cloud without any subject identifiable information and will only be recognized using the subject identification number provided during screening. The raw data of subjects' vital signs will be locked, encrypted, and can be read only by Study center team. The measurement method utilized by the app is Remote Photoplethysmography (rPPG). No medical decisions will be made based on the data obtained using the Comestai application, the reference devices, and the pre-scheduled blood sample results. **Measure:** Data Collection Storage and Processing-Oxygen saturation **Time Frame:** 15 minutes for data collection **Description:** Collect, verify and validate Respiratory rate (breaths per minute) in data using the Comestai application and reference devices. Respiratory rate data obtained using the Comestai application and reference data will be stored on Comestai's secured cloud without any subject identifiable information and will only be recognized using the subject identification number provided during screening. The raw data of subjects' vital signs will be locked, encrypted, and can be read only by Study center team. The measurement method utilized by the app is Remote Photoplethysmography (rPPG). No medical decisions will be made based on the data obtained using the Comestai application, the reference devices, and the pre-scheduled blood sample results. **Measure:** Data Collection Storage and Processing-Respiratory rate **Time Frame:** 15 minutes for data collection **Description:** Collect, verify and validate Blood pressure (mmHg) in data using the Comestai application and reference devices. Blood pressure data obtained using the Comestai application and reference data will be stored on Comestai's secured cloud without any subject identifiable information and will only be recognized using the subject identification number provided during screening. The raw data of subjects' vital signs will be locked, encrypted, and can be read only by Study center team. The measurement method utilized by the app is Remote Photoplethysmography (rPPG). No medical decisions will be made based on the data obtained using the Comestai application, the reference devices, and the pre-scheduled blood sample results. **Measure:** Data Collection Storage and Processing-Blood pressure **Time Frame:** 15 minutes for data collection #### Secondary Outcomes **Description:** Collect, verify and validate Hemoglobin level (g/dl) in data using the Comestai application and results of pre-scheduled blood tests Hemoglobin level data obtained using the Comestai application and results of pre-scheduled blood tests will be stored on Comestai's secured cloud without any subject identifiable information and will only be recognized using the subject identification number provided during screening. The raw data of subjects' vital signs will be locked, encrypted, and can be read only by Study center team. The measurement method utilized by the app is Remote Photoplethysmography (rPPG). No medical decisions will be made based on the data obtained using the Comestai application, the reference devices, and the pre-scheduled blood sample results. **Measure:** Data Collection Storage and Processing-Hemoglobin **Time Frame:** 15 minutes for data collection **Description:** Collect, verify and validate Hemoglobin glycosylated level (mmol/mol) in data using the Comestai application and results of pre-scheduled blood tests Hemoglobin glycosylated level data obtained using the Comestai application and and results of pre-scheduled blood tests will be stored on Comestai's secured cloud without any subject identifiable information and will only be recognized using the subject identification number provided during screening. The raw data of subjects' vital signs will be locked, encrypted, and can be read only by Study center team. The measurement method utilized by the app is Remote Photoplethysmography (rPPG). No medical decisions will be made based on the data obtained using the Comestai application, the reference devices, and the pre-scheduled blood sample results. **Measure:** Data Collection Storage and Processing-Hemoglobin glycosylated **Time Frame:** 15 minutes for data collection ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Prior to enrollment in this study, subjects must meet all the following inclusion criteria: 1. Subject must have the ability to understand and provide written informed consent. 2. Male or Female subject ≥16 and ≤65 of age. 3. Subject must be willing and able to comply with study procedures. Exclusion Criteria: Subjects will be excluded from the study if any of the following conditions are present: 1. Subject with compromised circulation, injury, or physical malformation of fingers, hands, ears or forehead/skull or other sensor Region of Interest (ROI) which would limit the ability to test ROI needed for the study. 2. Subject has a tattoo in the optical path which would limit the ability to test ROI needed for the study. 3. Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, respiration monitor electrodes or other medical sensors used for measuring vital signs. 4. Subject with a medical condition which in the opinion of the investigator, does not allow performing the study assessments. 5. Subject unfit to participate in the study to the judgment of the investigator. In addition to the Inclusion/Exclusion criteria, the 70% of target population should include adult subjects with at least one of the following: * Pre-diabetes or diabetes HbA1C 5.7-13% * \>30% of subjects with HbA1C 5.7-6.4% * \>30% of subjects with HbA1C \>6.4% * Hypertension with systolic measurements above 130 mmHg * \>40% of subjects with systolic BP \>130 mmHg * \>20% of subjects with systolic BP \>160 mmHg * Total cholesterol: \>40% of subjects with \>200 mg/dl and/or LDL above 130 mg/dl * Atrial fibrillation 1% * Smokers \~ 20-30% of all subjects in the study Note: the same subject can have more than one of the above medical conditions. It is preferred that subjects will be treatment- naive for the medical condition they suffer from or are not under treatment at the time of participation (e.g. a subject who suffers from hypertension has not started his treatment to lower his blood pressure). **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 16 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Potential adolescent and adult subjects (male and female ≥16 and ≤65 of age), of any race, physiques and skin pigmentation with awide range of health conditions who provided their consent by signing the informed consent form will be screened into the study and provided with a subject specific identification number used throughout the study (i.e. Subject ID). ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Gianvincenzo Zuccotti, MD, Prof **Phone:** +390263631 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Valeria Calcaterra, MD **Phone:** +390263631 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Buzzi Children's Hospital **Name:** Gianvincenzo Zuccotti, MD, Prof **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427551 **Acronym:** volupeng **Brief Title:** Volume Effect in Peng Block for Total Hip Replacement **Official Title:** Peng Block in Total Hip Replacement: Effects of Anesthetic Volume on Clinical Outcome and Postoperative Complications #### Organization Study ID Info **ID:** VOLUPENG #### Organization **Class:** OTHER **Full Name:** Azienda Ospedaliero, Universitaria Pisana ### Status Module #### Completion Date **Date:** 2024-01-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-01-30 **Type:** ACTUAL #### Start Date **Date:** 2022-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-04-26 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Azienda Ospedaliero, Universitaria Pisana #### Responsible Party **Investigator Affiliation:** Azienda Ospedaliero, Universitaria Pisana **Investigator Full Name:** Serena Ricalzone **Investigator Title:** principal investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study is to investigate whether a different volume of ropivacaine, with the same prescribed dosage based on body weight, can affect block efficacy, duration and side effects in the first 24 hours postoperatively. **Detailed Description:** patients were divided into 3 groups on the basis of the volume of anesthetic given to perform the block. in every patient was assessed the nrs, the side effects, if any, and the need for analgesic drugs in the first 24 hour after surgery ### Conditions Module **Conditions:** - Anesthesia - Post Operative Pain **Keywords:** - postoperative - orthopedic surgery ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 120 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** in this group of patients the peng block was performed with 15 ml of ropivacaine, whose dose was obtained on the weight **Intervention Names:** - Drug: Ropivacaine **Label:** 15 ml local anesthetic #### Arm Group 2 **Description:** in this group of patients the peng block was performed with 20 ml of ropivacaine, whose dose was obtained on the weight **Intervention Names:** - Drug: Ropivacaine **Label:** 20 ml local anesthetic #### Arm Group 3 **Description:** in this group of patients the peng block was performed with 30 ml of ropivacaine, whose dose was obtained on the weight **Intervention Names:** - Drug: Ropivacaine **Label:** 30 ml local anesthetic ### Interventions #### Intervention 1 **Arm Group Labels:** - 15 ml local anesthetic - 20 ml local anesthetic - 30 ml local anesthetic **Description:** The local anesthetic was dosed on the patient's weight (50-59kg: 120mg, 60-61kg: 140mg, 70-79kg: 160mg, ≥80kg: 180mg) **Name:** Ropivacaine **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Monitoring the onset of side effects (nausea/vomiting/hypotension/dizziness/sensitive impareiment) in every group of patients in the first 24 hours every six hours **Measure:** presence of side effects **Time Frame:** 24 hours **Description:** requirement of analgesic to control the pain, assessed every six hours **Measure:** analgesic requirements **Time Frame:** 24 hours #### Primary Outcomes **Description:** Evaluate pain for every volume group in the first 24 hours post surgery using the Numeric Pain Scale (NRS) assigning a numeric value between zero (no pain) and ten (the worst pain ever felt). Absence of relevant pain is considered a NRS less than three. Success of the block was defined as NRS≤3. **Measure:** NRS evaluation **Time Frame:** 24h post-op #### Secondary Outcomes **Description:** consider variation of pain, assessed with numeric Pain scale, for each group, every six hours **Measure:** NRS variation in time **Time Frame:** 24 h ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ASA I, ASA II, ASA III * Age≥18 * Total hip replacement surgery in spinal anesthesia * Informed consent Exclusion Criteria: * ASA IV * INR\>1.3 * platelet values\<100\*10\^3/ml a * patients on anticoagulant or antiplatelet therapy * general anesthesia for total hip replacement surgery * patients on chronic opioid therapy * altered sensitivity or motility * Patients in chronic opioid therapy * Refuse to sign informed consent form * Unable to sign informed consent form * Know allergies to medication used for analgesia **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients underwent total hip replacement in elective surgery ### Contacts Locations Module #### Locations **Location 1:** **City:** Pisa **Country:** Italy **Facility:** Edificio 3 - Azienda Ospedaliero Universitaria Pisana Cisanello **State:** Toscana **Zip:** 56124 #### Overall Officials **Official 1:** **Affiliation:** aoupisa **Name:** manuela nicastro, MD **Role:** STUDY_DIRECTOR ### 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: Post Operative Pain - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - 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: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M1700 - Name: Ropivacaine - Relevance: HIGH - As Found: Current - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077212 - Term: Ropivacaine ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427538 **Acronym:** RELIEF **Brief Title:** Chest Drain Regular Flushing in Complicated Parapneumonic Effusions and Empyemas **Official Title:** Chest Drain Regular Flushing in Complicated Parapneumonic Effusions and Empyemas #### Organization Study ID Info **ID:** 231367 #### Organization **Class:** OTHER **Full Name:** Vanderbilt University Medical Center ### Status Module #### Completion Date **Date:** 2025-10-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Vanderbilt University Medical Center #### Responsible Party **Investigator Affiliation:** Vanderbilt University Medical Center **Investigator Full Name:** Samira Shojaee **Investigator Title:** Associate Professor of Medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Infections of the pleural space are common, and patients require antibiotics and chest drain placement to evacuate the chest from the infected fluid. Chest drains can get blocked by the drainage fluid and material. For this reason, it is thought that flushing the chest drain with saline solution, can help maintain the patency of the tube. This proposed study will evaluate the impact of regular chest drain flushing on the length of time to chest tube removal and total hospitalization as well as improvement in chest imaging and the need for additional interventions on the infected space. **Detailed Description:** There are no randomized controlled trials (RCTs) evaluating the role of regular chest tube flushing in the setting of pleural space infection for optimal drainage and treatment outcomes. Most studies of \<16 Fr catheters have used both flushing and suction to decrease the likelihood of catheter blockage and improve drainage efficiency, however, this practice has never been studied prospectively or in RCTs. Regular flushing (e.g., 20-30 ml saline every 6 h via a three-way tap) is recommended for small chest drains by the British Thoracic Society (BTS) 2010 Guidelines. This practice is followed variably by some and not used by others. Importantly, the role of this practice in successful drainage of infected fluid, and patient-centric outcomes has not been investigated. Inconsistent flushing practices confound the interpretation of therapeutic modalities (such as intrapleural tissue plasminogen activator and deoxyribonuclease therapy) success or lack thereof and limit the execution of RCTs and prospective studies of the pleural space in the setting of infection. ### Conditions Module **Conditions:** - Empyema, Pleural - Pleural Infection **Keywords:** - empyema - pleural infection - chest tube - saline flush ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 96 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patient will receive 20 mL sterile saline flushes into their catheter by study team members every 6 ± 2 hours. If patients are receiving intrapleural tissue plasminogen activator and deoxyribonuclease therapy, each treatment will be considered one flush. **Intervention Names:** - Other: Saline Flush **Label:** Saline Intervention Arm **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patient will receive a saline flush as needed, to restore patency of a chest tube considered blocked. No routine flushes will be administered. **Label:** No Intervention Arm **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Saline Intervention Arm **Description:** sterile saline 20 mL flushed into their catheter by trained nurses or study team members every 6 ± 2 hours **Name:** Saline Flush **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The investigators will assess the time from randomization (within 24 hours of chest tube placement) until time to chest tube removal **Measure:** Time to chest tube removal **Time Frame:** up to 3 months #### Secondary Outcomes **Measure:** Length of hospitalization **Time Frame:** up to 365 days **Measure:** Radiographic improvement as evidenced by chest x-ray at the time of chest tube placement compared to the time of removal **Time Frame:** through study completion, an average of 3 months **Description:** number of additional procedures through study completion **Measure:** Additional surgical procedures for the management of pleural space infection **Time Frame:** an average of 3 months **Measure:** Complications **Time Frame:** through study completion, an average of 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with complicated parapneumonic pleural effusion and empyema requiring chest tube placement as standard of care for inpatient management of their pleural space infection with or without intrapleural tissue plasminogen activator and deoxyribonuclease therapy * Age \> 18 years old. Exclusion Criteria: * Patients who have surgical tubes that can't accommodate a three-way stopcock. * Study subject has any disease or condition that interferes with the safe completion of the study. * Inability to provide informed consent. * Inability to undergo a chest X-ray. * If the managing clinician believes the chest tube will be placed for less than 24 hours. * Patients with an indwelling pleural catheter (IPC) **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Samira Shojaee, MD, MPH **Phone:** 615-322-2386 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Jennifer Duke, MD **Phone:** 615-322-2386 **Role:** CONTACT #### Locations **Location 1:** **City:** Nashville **Country:** United States **Facility:** Vanderbilt University Medical Center **State:** Tennessee **Zip:** 37203 #### Overall Officials **Official 1:** **Affiliation:** Vanderbilt University **Name:** Jennifer D Duke, MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** Deidentified data will be shared with other researchers **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007239 - Term: Infections - ID: D000012877 - Term: Skin Manifestations - ID: D000013492 - Term: Suppuration - ID: D000007249 - Term: Inflammation - ID: D000010335 - Term: Pathologic Processes - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000010995 - Term: Pleural Diseases - 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 ### 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: M7819 - Name: Empyema - Relevance: HIGH - As Found: Empyema - ID: M19086 - Name: Empyema, Pleural - Relevance: HIGH - As Found: Empyema, Pleural - ID: M8610 - Name: Flushing - Relevance: HIGH - As Found: Flushing - ID: M15680 - Name: Skin Manifestations - Relevance: LOW - As Found: Unknown - ID: M16273 - Name: Suppuration - Relevance: LOW - As Found: Unknown - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M13885 - Name: Pleural Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004653 - Term: Empyema - ID: D000016724 - Term: Empyema, Pleural - ID: D000005483 - Term: Flushing ### Intervention Browse Module - Browse Branches - Abbrev: FiAg - Name: Fibrinolytic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M13848 - Name: Plasminogen - Relevance: LOW - As Found: Unknown - ID: M13849 - Name: Tissue Plasminogen Activator - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427525 **Acronym:** obesity **Brief Title:** The Effect of Mobile Application Supported Health Promotion Program on Obesity of Adolescents **Official Title:** The Effect of Mobile Application Supported Health Promotion Program on Obesity, Physical Activity and Stress Levels of Adolescents #### Organization Study ID Info **ID:** Mobile Application Health #### Organization **Class:** OTHER **Full Name:** Istanbul University - Cerrahpasa (IUC) ### Status Module #### Completion Date **Date:** 2024-05-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-25 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-04-14 **Type:** ACTUAL #### Start Date **Date:** 2024-02-14 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2023-10-07 **Study First Submit QC Date:** 2024-05-18 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Istanbul University - Cerrahpasa (IUC) #### Responsible Party **Investigator Affiliation:** Istanbul University - Cerrahpasa (IUC) **Investigator Full Name:** Cumali Yıldızdal **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The aim of the study is to evaluate the effectiveness of the Child Obesity Program (COP), which is a school-based, parent-based, weight management program aimed mobile application at preventing overweight and obesity in childhood. **Detailed Description:** The aim of the study is to evaluate the effectiveness of the Child Obesity Program (COP), which is a school-based, parent-based, weight management program aimed mobile application at preventing overweight and obesity in childhood. The program aims to provide children with positive health behaviors, gain cognitive and behavioral skills that will enable them to increase their knowledge of physical activity, nutrition and stress management. ### Conditions Module **Conditions:** - Adolescents - Mobile Application - School Health - Physical Activity - Nutrition Disorder, Child ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 70 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** mobile application at preventing overweight and obesity in childhood **Intervention Names:** - Other: Mobile application-based adolecent obesity education **Label:** Intervention group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** health education **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention group **Description:** Mobile application-based adolecent obesity education **Name:** Mobile application-based adolecent obesity education **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** higher scores mean a better **Measure:** Healthy Lifestyle Behaviors Scale **Time Frame:** 4 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Obesity Adolescents Exclusion Criteria: non-obese child **Healthy Volunteers:** True **Maximum Age:** 16 Years **Minimum Age:** 10 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** İstanbul **Country:** Turkey **Facility:** Florance Nightingale Nursing Faculty **Zip:** 34000 #### Overall Officials **Official 1:** **Affiliation:** Istanbul University - Cerrahpasa (IUC) **Name:** Cumali Yıldızdal, phd student **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### 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: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: HIGH - As Found: Nutrition Disorders - ID: M18049 - Name: Child Nutrition Disorders - Relevance: HIGH - As Found: Nutrition Disorder, Child ### Condition Browse Module - Meshes - ID: D000009748 - Term: Nutrition Disorders - ID: D000015362 - Term: Child Nutrition Disorders ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427512 **Brief Title:** Mechanisms Underlying Cardiovascular Consequences Associated With COVID-19 and Long COVID **Official Title:** Mechanisms Underlying Cardiovascular Consequences Associated With COVID-19 and Long COVID - Characterizing Long COVID Phenotypes Using Physiological and Molecular Studies #### Organization Study ID Info **ID:** AAA-TBA #### Organization **Class:** OTHER **Full Name:** Columbia University ### Status Module #### Completion Date **Date:** 2025-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** WITHDRAWN #### Primary Completion Date **Date:** 2025-03 **Type:** ESTIMATED #### Start Date **Date:** 2022-03 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2022-02-01 **Study First Submit QC Date:** 2024-05-20 **Why Stopped:** Funding not available ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** American Heart Association #### Lead Sponsor **Class:** OTHER **Name:** Columbia 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:** AIM 1. Characterize cardiovascular phenotypes of long COVID by cardiopulmonary, meta-bolic, and cardiac mechanical/physiological responses to exercise and microvascular vasomotor function. AIM 2. Identify intercellular signaling between immune cells and cardiac cells associated with microvascular phenotypes of long COVID. **Detailed Description:** As many as 40-60% of patients who recovered from mild or moderate acute COVID have reported what is now called long COVID - multiple, persistent or recurrent symptoms lasting 6-9 months (or longer) following initial illness.1-4 Fatigue, dyspnea, and chest pain are the most common symptoms. Others include palpitations, lightheadedness, and syncope. All these cardiovascular symptoms can be debilitating, resulting in worse quality of life and morbidity.5, 6 Treatment options are limited. ### Conditions Module **Conditions:** - COVID-19 **Keywords:** - long COVID-19 ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with long COVID-19 and experiencing cardiovascular symptoms at 24 weeks post-acute illness or post-COVID without cardiovascular symptoms by 8 weeks after illness. **Label:** COVID patients ### Outcomes Module #### Primary Outcomes **Description:** This is to measure the microvascular dysfunction in patients using Cardiac PET. **Measure:** Prevalence of Microvascular dysfunction **Time Frame:** Up to 2.5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age \> 18, \< 75 yrs * History of lab-confirmed COVID * Symptomatic at \>12 wks post-acute COVID (cases) * Recovered by 8wks post-acute COVID (controls) Exclusion Criteria: * Any history of critical illness * Chronic kidney disease, Stage \>4 * Pre-COVID: HFrEF, CABG, arrhythmia; pulmonary hypertension, pulmonary embolus, interstitial lung disease (ILD), O2 dependence; dementia, stroke, autonomic dysfunction; coagulopathy * Post-COVID: ILD, O2 dependence **Maximum Age:** 74 Years **Minimum Age:** 19 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study population will be recruited primarily from the Prospective COVID-19 ID Persistence Cohort (C-PIC). ### Contacts Locations Module #### Locations **Location 1:** **City:** New York **Country:** United States **Facility:** CUIMC **State:** New York **Zip:** 10032 #### Overall Officials **Official 1:** **Affiliation:** Florence Irving Associate Professor of Medicine, Dept of Medicine Cardiology **Name:** Emily Tsai, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Blomberg B, Mohn KG, Brokstad KA, Zhou F, Linchausen DW, Hansen BA, Lartey S, Onyango TB, Kuwelker K, Saevik M, Bartsch H, Tondel C, Kittang BR; Bergen COVID-19 Research Group; Cox RJ, Langeland N. Long COVID in a prospective cohort of home-isolated patients. Nat Med. 2021 Sep;27(9):1607-1613. doi: 10.1038/s41591-021-01433-3. Epub 2021 Jun 23. **PMID:** 34163090 **Citation:** Nehme M, Braillard O, Alcoba G, Aebischer Perone S, Courvoisier D, Chappuis F, Guessous I; COVICARE TEAM. COVID-19 Symptoms: Longitudinal Evolution and Persistence in Outpatient Settings. Ann Intern Med. 2021 May;174(5):723-725. doi: 10.7326/M20-5926. Epub 2020 Dec 8. No abstract available. **PMID:** 33284676 **Citation:** Nehme M, Braillard O, Chappuis F, Courvoisier DS, Guessous I; CoviCare Study Team. Prevalence of Symptoms More Than Seven Months After Diagnosis of Symptomatic COVID-19 in an Outpatient Setting. Ann Intern Med. 2021 Sep;174(9):1252-1260. doi: 10.7326/M21-0878. Epub 2021 Jul 6. **PMID:** 34224254 **Citation:** Soriano JB, Murthy S, Marshall JC, Relan P, Diaz JV; WHO Clinical Case Definition Working Group on Post-COVID-19 Condition. A clinical case definition of post-COVID-19 condition by a Delphi consensus. Lancet Infect Dis. 2022 Apr;22(4):e102-e107. doi: 10.1016/S1473-3099(21)00703-9. Epub 2021 Dec 21. **PMID:** 34951953 **Citation:** Huang L, Yao Q, Gu X, Wang Q, Ren L, Wang Y, Hu P, Guo L, Liu M, Xu J, Zhang X, Qu Y, Fan Y, Li X, Li C, Yu T, Xia J, Wei M, Chen L, Li Y, Xiao F, Liu D, Wang J, Wang X, Cao B. 1-year outcomes in hospital survivors with COVID-19: a longitudinal cohort study. Lancet. 2021 Aug 28;398(10302):747-758. doi: 10.1016/S0140-6736(21)01755-4. Erratum In: Lancet. 2022 May 7;399(10337):1778. **PMID:** 34454673 **Citation:** Sigfrid L, Drake TM, Pauley E, Jesudason EC, Olliaro P, Lim WS, Gillesen A, Berry C, Lowe DJ, McPeake J, Lone N, Munblit D, Cevik M, Casey A, Bannister P, Russell CD, Goodwin L, Ho A, Turtle L, O'Hara ME, Hastie C, Donohue C, Spencer RG, Donegan C, Gummery A, Harrison J, Hardwick HE, Hastie CE, Carson G, Merson L, Baillie JK, Openshaw P, Harrison EM, Docherty AB, Semple MG, Scott JT; ISARIC4C investigators. Long Covid in adults discharged from UK hospitals after Covid-19: A prospective, multicentre cohort study using the ISARIC WHO Clinical Characterisation Protocol. Lancet Reg Health Eur. 2021 Sep;8:100186. doi: 10.1016/j.lanepe.2021.100186. Epub 2021 Aug 6. **PMID:** 34386785 ## 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 - ID: D000094025 - Term: Post-Infectious Disorders - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### 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: COVID-19 - ID: M3013 - Name: Post-Acute COVID-19 Syndrome - Relevance: HIGH - As Found: Long COVID - ID: M16355 - Name: Syndrome - 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: 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 - ID: M3014 - Name: Post-Infectious Disorders - 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: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000086382 - Term: COVID-19 - ID: D000094024 - Term: Post-Acute COVID-19 Syndrome ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427499 **Brief Title:** The Clinical of Stannous Fluoride Toothpaste and a Newly Designed Toothbrush Compared to Colgate Cavity Protection Toothpaste and a Regular Toothbrush in Reducing Plaque and Gingivitis. **Official Title:** The Clinical Investigation of Stannous Fluoride Toothpaste and a Newly Designed Toothbrush Compared to Colgate Cavity Protection Toothpaste and a Regular Toothbrush in Reducing Plaque and Gingivitis: A Three-Month Study in Thailand #### Organization Study ID Info **ID:** CRO-2024-04-PGN-BKS-YPZ #### Organization **Class:** INDUSTRY **Full Name:** Colgate Palmolive ### Status Module #### Completion Date **Date:** 2024-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Colgate Palmolive #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** Qualified subjects will be enrolled and randomly assigned to either of the two study groups based on their initial Plaque and Gingivitis scores. During the first visit, subjects will undergo three key procedures: 1) evaluation for baseline plaque and gingivitis, 2) brushing with the assigned regimen products for two minutes, and 3) assessment for post-brushing plaque only. Subjects will be provided with clear instructions for regimen product usage and will be expected to adhere to these instructions. Follow-up evaluations for plaque and gingivitis will be conducted at one week, six weeks, and three months after initiation of regimen product use. Throughout the study period, continuous monitoring for adverse events will be carried out for all subjects. ### Conditions Module **Conditions:** - Plaque - Gingivitis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Stannous fluoride toothpaste **Label:** Stannous Fluoride Toothpaste **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** MFP Fluoride toothpaste **Intervention Names:** - Drug: Colgate Cavity Protection Toothpaste **Label:** Colgate Cavity Protection Toothpaste **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Stannous Fluoride Toothpaste **Description:** brush 2 min morning \& night daily **Name:** Stannous fluoride toothpaste **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Colgate Cavity Protection Toothpaste **Description:** brush 2 min morning \& night daily **Name:** Colgate Cavity Protection Toothpaste **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** A Loe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scoreable surface and dividing that number by the total number of surfaces scored. **Measure:** Loe and Silness Gingival Index. **Time Frame:** baseline, one week, six weeks and three months **Description:** A Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth score for each subject will be determined by adding the values given by the dental examiner to each scoreable surface and dividing that number by the total number of surfaces scored. **Measure:** Quigley and Hein Plaque Index **Time Frame:** baseline, one week, six weeks and three months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Subjects, ages 18-70, inclusive. * Availability for the three-month duration of the clinical research study. * Good general health. * Minimum of 20 uncrowned permanent natural teeth (excluding third molars). 5. Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index. * Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification). * Signed Informed Consent Form Exclusion Criteria: * Presence of orthodontic bands. * Presence of partial removable dentures. * Tumor(s) of the soft or hard tissues of the oral cavity. * Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone). * Five or more carious lesions requiring immediate restorative treatment. * Antibiotic use any time during the one-month period prior to entry into the study. * Participation in any other clinical study or test panel within the one month prior to entry into the study. * Dental prophylaxis during the past two weeks prior to baseline examinations. * History of allergies to oral care/personal care consumer products or their ingredients. * On any prescription medicines that might interfere with the study outcome. * An existing medical condition that prohibits eating or drinking for periods up to 4 hours. * History of alcohol or drug abuse. * Pregnant or lactating subjects **Healthy Volunteers:** True **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:** Terdphong Triratana **Phone:** 66-81-311-3986 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** M U International Oral Science Research, Ltd **Name:** Terdphong Triratana **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007239 - Term: Infections - ID: D000005882 - Term: Gingival Diseases - ID: D000010510 - Term: Periodontal Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M9003 - Name: Gingivitis - Relevance: HIGH - As Found: Gingivitis - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M8994 - Name: Gingival Diseases - 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 ### Condition Browse Module - Meshes - ID: D000005891 - Term: Gingivitis ### Intervention Browse Module - Ancestors - ID: D000002327 - Term: Cariostatic Agents - ID: D000020011 - Term: Protective Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M8587 - Name: Fluorides - Relevance: HIGH - As Found: Components - ID: M140080 - Name: Listerine - Relevance: LOW - As Found: Unknown - ID: M15771 - Name: Sodium Fluoride - Relevance: LOW - As Found: Unknown - ID: M16759 - Name: Tin Fluorides - Relevance: HIGH - As Found: Establishing - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000005459 - Term: Fluorides - ID: D000014002 - Term: Tin Fluorides ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427486 **Brief Title:** Telecoaching Intervention for Children With Autism and Their Parents in Palestine **Official Title:** Investigating the Potential Efficacy, Feasibility, and Acceptability of Parent Telecoaching Intervention on Children With Autism and Their Parents in Palestine: A Mixed-Method Pilot Randomized Controlled Trial #### Organization Study ID Info **ID:** Parent Telecoaching and ASD #### Organization **Class:** OTHER **Full Name:** Arab American University (Palestine) ### Status Module #### Completion Date **Date:** 2025-03-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-03-02 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-18 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Arab American University (Palestine) #### Responsible Party **Investigator Affiliation:** Arab American University (Palestine) **Investigator Full Name:** Mohammad Salahat **Investigator Title:** Instructor/ Head of Speech, Language, and Hearing Disorders Department **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** In Palestine, children with autism spectrum disorder and their parents face difficulties in receiving needed early intervention and rehabilitation services due to a lack of specialized professionals and centers, as well as cultural, political, geographical, and financial barriers. Parents also face difficulties in raising their children with autism in their homes as they lack knowledge about the disorder and the best interventions that can be used to help these children. Parent telecoaching intervention, or what is called (distance coaching via technology) can help parents and their children with autism. However, no research exists studying the possibility of using this intervention with parents and their children in Palestine and if it can have positive results on both parents and children. The goal of this trial is to learn if parent telecoaching intervention is feasible and acceptable to parents of children with autism in Palestine. It will also learn if this intervention has the potential to improve children's skills and increase parent's self-competency and quality of life. The main questions it aims to answer are: * To what extent and in what ways is providing telecoaching intervention for parents of children with Autism in Palestine possible? * How do parents see telecoaching intervention in terms of suitability, benefits, facilitators, and barriers? * Does telecoaching intervention for parents have the potential to increase children's participation in daily activities that parents consider important? * Does telecoaching intervention have the potential to enhance parents' self-competence and family quality of life? Researchers will compare parent telecoaching intervention to a web-based resource designed to provide parents with general information about autism to see if parent telecoaching intervention works to help children with autism and their parents more than the free autism resources provided on the website. Participants will: * Take a telecoaching intervention (eight sessions over eight weeks, each session lasts one hour) or use the information provided on the website about autism. * Apply the planned strategies with their children during the week and record their work using videos or by filling out a form to be reviewed at the beginning of each session. **Detailed Description:** A purposive sampling technique will be used to recruit children with Autism Spectrum Disorder and their parents/caregivers who live in the West Bank districts. Two recruitment strategies will be used to invite participants from various districts in the West Bank. The first will involve approaching a third party, the Superhero Autism Foundation, to distribute invitation packages to potential eligible participants based on the provided inclusion and exclusion criteria. This foundation has been chosen as it has access to a vast dataset of children with autism across the West Bank. The second strategy will involve advertising flyers on social media and patient organization websites. Those who wish to participate will be asked to send their signed reply slip form to the trial's author using the contact information provided (email or WhatsApp). After that, they will be contacted by phone to screen their eligibility. Parents who meet the eligibility criteria will be informed that an initial meeting with each one of them will be conducted to explain the purpose of the trial further, check their willingness to be randomized, answer any questions they may have, confirm their consent to participate, agree on the first assessment meeting date and time which will be done before randomization, and discuss the schedule of the subsequent telecoaching sessions. Sample size: A pilot randomized trial typically does not require a sample power calculation. However, as a rule of thumb, at least 30 participants will be needed for a pilot Randomized Controlled Trial. To address a potential attrition rate of 10%, 40 parent-child dyads (20 in each group) will be recruited. Randomisation: The study will employ a stratified block randomization method to assign parents to either the telecoaching intervention group or the waitlist control group in a 1:1 ratio. Once baseline assessments are completed with eligible participants who have consented to participate, a screening number will be allocated to each parent, and the child's autism symptoms score will be recorded. This score will be categorized as \<60 or ≥60 using the Autism Treatment Evaluation Checklist. The assigned screening number and the child's autism severity score for each participant will then be sent to a non-study member, a lecturer in the Occupational Therapy Department, who will conduct the allocation and randomization process based on predetermined block sizes of four using a computer-generated random sequence. Stratification will be conducted based on autism severity categorized as \<60 or ≥60. This method is chosen to ensure an equal distribution of participants in each group and to minimize the impact of children's autism severity. The trial author responsible for enrolling participants will not have access to the concealed random allocation sequence. However, due to the nature of the intervention, blinding the treatment assigned to participants will not be feasible. All data from randomized participants will be recorded in a Case Report Form (CRF). Participants will be informed of the randomization outcome via phone contact. Quantitative Data Analysis: The Statistical Package for the Social Sciences (SPSS) version 26 will be used to conduct all statistical analyses. Descriptive statistics will be used to analyze the following: * Feasibility Criterions (1,3, 4, 6): eligibility, retention, provider intervention fidelity, and adverse event (if it occurs). * Participants' demographic data will be analysed using percentages, mean, and standard deviation). * The commonalities among family-specified goals on the Canadian Occupational Performance Measure (COPM). Inferential statistics (Potential efficacy of Parent telecoaching intervention): A t-test will be used to examine changes in means from pre-to-post-tests (between and within groups). Qualitative Analysis (Acceptability, benefits, facilitators and barriers): The recorded interviews will be analyzed using six iterative steps: (1) familiarization, (2) initial coding, (3) theme identification, (4) theme review, (5) theme definition and naming, and (6) report production. The trial author and a colleague will review and create initial codes, revisit the full transcriptions, and search for themes using the codes. They will meet multiple times to ensure theme names accurately describe the reports. ### Conditions Module **Conditions:** - Autism Spectrum Disorder **Keywords:** - telecoaching - Telehealth - Early intervention - Quality of life - parent's self-competency - Activities of daily living - occupational performance coaching ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This is a mixed-method pilot randomized waitlist-controlled trial with two parallel groups: the telecoaching intervention group and the waitlist control group, and semi-structured interviews with intervention participants. The utilization of a waitlist control group enables the comparison of the potential effects of the intervention group with those of a control group while ensuring that parents in the wait-listed control group can have access to telecoaching intervention after the completion of the study. After completing telecoaching sessions, participants from the intervention group will be invited to participate in semi-structured interviews to explore their perceptions about the intervention. The reason for using a mixed method is to achieve a comprehensive understanding of telecoaching intervention (its feasibility, acceptability, and potential efficacy) and to explain findings by connecting information obtained from both designs. ##### Masking Info **Masking:** NONE **Masking Description:** The trial author responsible for enrolling participants will not have access to the concealed random allocation sequence. However, due to the nature of the intervention, blinding the treatment assigned to participants will not be feasible. **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The telecoaching intervention will consist of eight weekly sessions, lasting between 40 minutes to one hour each, conducted through Zoom. Before the sessions begin, an initial assessment meeting will take place with each parent. The sessions will follow the occupational performance coaching (OPC) processes, which aim to enhance parents' problem-solving skills and promote children's participation. These processes include the Connect, Structure, and Share stages, focusing on active listening, goal-setting, and information exchange between the provider and the parent. A Casenote template will be used to organize these sessions. **Intervention Names:** - Other: Parents Telecoaching Intervention **Label:** Parent Telecoaching Intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The Waitlist Control Group Intervention will have access to a web-based Autism resources called "Sanad Al-Haya". This resource provides general information and videos on Autism and how to manage specific needs such as sensory issues, social interaction, and activities of daily living. The resources are developed by the trial author in Arabic language. All participants are required to register on the Sanad platform and create an account in their child's name. If they wish, the waitlist control group will have the option to take parent telecoaching sessions after the intervention group has completed all sessions. **Label:** Access to a web-based (sanadmed). **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Parent Telecoaching Intervention **Description:** - Synchronous (Zoom platform) and Asynchronous coaching sessions for parents of children with autism. **Name:** Parents Telecoaching Intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** is used to help parents identify and prioritize the goals they want their child to achieve in the domains of self-care, productivity, and leisure. The tool involves parents rating each identified goal on a scale of 1 to 10, with 1 indicating that the goal is not important and 10 indicating that it is extremely important. From the list of identified goals, parents select the top five that they want to work on during the intervention. Parents then rate their child's performance and their satisfaction with that performance on a scale of 1 to 10, with 1 indicating that they are not satisfied and 10 indicating that they are extremely satisfied. This helps to measure changes in parents' perception of their child's performance and their satisfaction with that change from pre-test to post-test. The COPM has demonstrated sound psychometric properties with parents of children with disabilities, including construct validity and criterion validity. **Measure:** Canadian Occupational Performance Measure **Time Frame:** Baseline, pre-intervention #### Secondary Outcomes **Description:** is used to evaluate the quality of life of parents using a 36-item Likert-type scale that measures eight domains (general health, physical role limitation, role limitation arising from emotional issues, physical functioning, vitality, mental health, bodily pain, and social function). The SF-36 questionnaire provides scores ranging from 0 to 100, with higher scores indicating better QoL. The questionnaire has been translated into Arabic, culturally validated, and utilized in research aimed at investigating the QoL of parents of children who have autism. **Measure:** The 36-Item Short Form Health Survey questionnaire (SF-36) **Time Frame:** Baseline, pre-intervention **Description:** This is a 29-item Arabic scale that measures parental competence for children with ASD. Each item has a 5-point rating scale. The scale is used to rate statements based on whether parents agree or disagree with them. A score of 5 is given to "Strongly Agree," while a score of 1 is given to "Strongly Disagree" for positive statements. For negative statements, the score is reversed. The minimum score is 29, while the maximum is 145. The validity of the tool was ensured by specialized staff in education psychology, and the reliability of the tool was tested demonstrating acceptable value (Cronbach Alpha 0.89). **Measure:** Parental Competence Scale for Children with Autism Spectrum Disorder **Time Frame:** Baseline, pre-intervention **Description:** This tool is used to identify the severity of autism and assess the effectiveness of interventions and treatments. It comprises of 77 questions that are divided into four categories: speech/language/communication (14 questions), sociability (20 questions), sensory/cognitive awareness (18 questions), and health/physical/behavior (25 questions). Parents or caregivers are responsible for completing the checklist, and lower scores indicate milder symptoms. The ATEC has been translated into Arabic and validated, revealing good internal consistency (a= 0.84), content validity (90% among referees), and construct validity **Measure:** Autism Treatment Evaluation Checklist (ATEC) **Time Frame:** Baseline, pre-intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Parents are the primary caregivers spending most of the intervention period with their child * Parents are at least 18 years old and able to provide informed consent * Parents have access to mobile devices such as phones, tablets or computers with Zoom software and a stable internet connection * The children are between the ages of 3 and 6 years old and have a confirmed ASD diagnosis from a psychiatrist or pediatrician. * Children with ASD and other comorbid conditions are also eligible to participate. Exclusion Criteria: * Adolescents and older adults with ASD. **Maximum Age:** 6 Years **Minimum Age:** 3 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Mohammad Salahat **Phone:** 0592345678 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Hisham A Arabkabeya, Asst. Prof. **Phone:** 0595637776 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Arab American University (Palestine) **Name:** Mohammad Salahat, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Aschbrenner KA, Kruse G, Gallo JJ, Plano Clark VL. Applying mixed methods to pilot feasibility studies to inform intervention trials. Pilot Feasibility Stud. 2022 Sep 26;8(1):217. doi: 10.1186/s40814-022-01178-x. **PMID:** 36163045 **Citation:** Dahl-Popolizio S, Carpenter H, Coronado M, Popolizio NJ, Swanson C. Telehealth for the Provision of Occupational Therapy: Reflections on Experiences During the COVID-19 Pandemic. Int J Telerehabil. 2020 Dec 8;12(2):77-92. doi: 10.5195/ijt.2020.6328. Erratum In: Int J Telerehabil. 2021 Jun 22;13(1):e6382. **PMID:** 33520097 **Citation:** Dunn W, Little LM, Pope E, Wallisch A. Establishing Fidelity of Occupational Performance Coaching. OTJR (Thorofare N J). 2018 Apr;38(2):96-104. doi: 10.1177/1539449217724755. Epub 2017 Aug 18. **PMID:** 28821218 **Citation:** Efird J. Blocked randomization with randomly selected block sizes. Int J Environ Res Public Health. 2011 Jan;8(1):15-20. doi: 10.3390/ijerph8010015. Epub 2010 Dec 23. **PMID:** 21318011 **Citation:** Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016 Oct 21;2:64. doi: 10.1186/s40814-016-0105-8. eCollection 2016. **PMID:** 27965879 **Citation:** Little LM, Pope E, Wallisch A, Dunn W. Occupation-Based Coaching by Means of Telehealth for Families of Young Children With Autism Spectrum Disorder. Am J Occup Ther. 2018 Mar/Apr;72(2):7202205020p1-7202205020p7. doi: 10.5014/ajot.2018.024786. **PMID:** 29426380 **Citation:** Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19. **PMID:** 26092476 **Citation:** Yazdani S, Capuano A, Ghaziuddin M, Colombi C. Exclusion Criteria Used in Early Behavioral Intervention Studies for Young Children with Autism Spectrum Disorder. Brain Sci. 2020 Feb 13;10(2):99. doi: 10.3390/brainsci10020099. **PMID:** 32069875 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002659 - Term: Child Development Disorders, Pervasive - 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 ### Condition Browse Module - Browse Leaves - ID: M4623 - Name: Autistic Disorder - Relevance: HIGH - As Found: Autism - ID: M206 - Name: Autism Spectrum Disorder - Relevance: HIGH - As Found: Autism Spectrum Disorder - ID: M5903 - Name: Child Development Disorders, Pervasive - Relevance: LOW - As Found: Unknown - ID: M5902 - Name: Developmental Disabilities - 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 - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001321 - Term: Autistic Disorder - ID: D000067877 - Term: Autism Spectrum Disorder ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427473 **Brief Title:** Effectiveness of a Combined Diet and Mindfulness Program on Weight Loss in Breast Cancer Survivors **Official Title:** Effectiveness of a Combined Diet and Mindfulness Program on Weight Loss in Breast Cancer Survivors: A Randomized Controlled Trial #### Organization Study ID Info **ID:** NYCU113018AE #### Organization **Class:** OTHER **Full Name:** National Yang Ming Chiao Tung University ### Status Module #### Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-14 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** National Yang Ming Chiao Tung University #### Responsible Party **Investigator Affiliation:** National Yang Ming Chiao Tung University **Investigator Full Name:** I-Ching Hou **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The study addresses the pressing issue of overweight and obesity among breast cancer patients, which exacerbates recurrence rates and mortality risks. Its primary objective is to assess the efficacy of two intervention models, the Diet, Exercise, and Mindfulness (DEM) model and the Diet and Exercise (DE) model, in facilitating weight loss, enhancing self-efficacy, mindfulness, and quality of life. The anticipated outcomes include long-term engagement in online self-learning, overcoming the limitations of ineffective self-management learning, and empowering healthcare professionals with scenario-based teaching materials. Through online platforms, patients can learn and review without constraints, ultimately achieving a holistic balance among physical, mental, and spiritual health. **Detailed Description:** \[Research Background\] Breast cancer ranks first among cancers in women worldwide, with overweight and obesity being one of the high-risk factors for breast cancer. Moreover, overweight individuals within the breast cancer patient population also face higher recurrence rates and mortality risks. Assisting overweight or obese breast cancer women in weight loss to promote their well-being was the initial idea behind this study. The most common weight loss strategies include dietary management and regular exercise. In recent years, more studies have shown that effective weight loss also requires psychological interventions. Therefore, this study will combine dietary, exercise, and mindfulness-related interventions to assist breast cancer patients in more effective weight management. \[Research Objectives\] To compare the effectiveness of two intervention measures, the Diet, Exercise, and Mindfulness (DEM) model and the Diet and Exercise (DE) model, on weight loss, self-efficacy, mindfulness tendency, and quality of life. \[Research Method\] The study will involve a quantitative study, which plans to carry out a randomized controlled trial (RCT). This trial will compare the effects of two intervention measures, the DEM model and the DE model, on weight loss, self-efficacy, mindfulness tendency, and quality of life. \[Expected Results\] Through the intervention provided by this study, patients can engage in long-term online self-learning and supplementary learning after returning home, reducing the limitations of ineffective self-management learning caused by negative emotions, treatment side effects, and sequelae in the early stages of cancer. Healthcare professionals can also use scenario-based teaching materials produced by this study to guide breast cancer survivors with ineffective weight self-management skills in practicing the necessary skills. Additionally, through online learning, patients can learn and review without pressure, saving time on transportation, easing carbon foot print and relearning effective weight management skills; even if they have faced major life threats in the past, they can turn adversity into blessings, achieving a balance among physical, mental, and spiritual health. ### Conditions Module **Conditions:** - Breast Cancer - Weight Loss **Keywords:** - weight management - breast cancer survivors - mindfulness - Food Frequency Questionnaire ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** subjects participate diet, exercise and mindfulness programs **Intervention Names:** - Behavioral: Dietary program - Behavioral: Exercise program - Behavioral: Mindfulness program **Label:** DEM model **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** subjects participate diet and exercise programs **Intervention Names:** - Behavioral: Dietary program - Behavioral: Exercise program **Label:** DE model **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - DE model - DEM model **Description:** Participants will attend 8-week online dietary course. In addition to weekly classes, participants are required to photograph each meal. **Name:** Dietary program **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - DE model - DEM model **Description:** Everyday walking steps more than 4000 steps. To accurately track participants' daily step counts, the research team provided quailfied pedometers. **Name:** Exercise program **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - DEM model **Description:** Participants will attend 8-week online mindfulness course. In addition to weekly classes, participants practiced mindfulness individually for 5 minutes each day and maintained a mindfulness diary. **Name:** Mindfulness program **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** BMI in kg/m2 (weight in kilograms divided by height in meters squared) **Measure:** Physiological indicator I **Time Frame:** baseline, 8 weeks, 24 weeks, 48 weeks **Description:** Waist circumference in centimeter **Measure:** Physiological indicator II **Time Frame:** baseline, 8 weeks, 24 weeks, 48 weeks **Description:** Body fat in percentage **Measure:** Physiological indicator III **Time Frame:** baseline, 8 weeks, 24 weeks, 48 weeks **Description:** Muscle mass in kilograms **Measure:** Physiological indicator IV **Time Frame:** baseline, 8 weeks, 24 weeks, 48 weeks **Description:** Food Frequency Questionnaire **Measure:** Food Intake Frequency **Time Frame:** baseline, 8 weeks, 24 weeks, 48 weeks **Description:** The minimum value is 1 and maximum value is 6, and higher scores mean a better outcome. **Measure:** Mindful Awareness Attention **Time Frame:** baseline, 8 weeks, 24 weeks, 48 weeks #### Secondary Outcomes **Description:** The minimum value is 0 and maximum value is 10, and higher scores mean a better outcome. **Measure:** Weight Efficacy Lifestyle Questionnaire **Time Frame:** baseline, 8 weeks, 24 weeks, 48 weeks **Description:** 1. Item 1 to 28 the minimum value is 1 and maximum value is 4, and lower scores mean a better outcome. 2. Item 29 to 30 the minimum value is 1 and maximum value is 7, and higher scores mean a better outcome. **Measure:** European Organization for Research and Treatment of Cancer Quality of Life Questionnaire **Time Frame:** baseline, 8 weeks, 24 weeks, 48 weeks **Description:** The minimum value is 1 and maximum value is 4, and lower scores mean a better outcome. **Measure:** Breast Cancer-Specific Quality of Life Questionnaire **Time Frame:** baseline, 8 weeks, 24 weeks, 48 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * stage I-III breast cancer and completed treatment * Body mass index (BMI) is greater than or equal to 24 kg/m2 * possess a smartphone Exclusion Criteria: * Pregnant or planning to become pregnant within six months * Those who are unable to walk **Maximum Age:** 65 Years **Minimum Age:** 20 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** I-Ching Hou **Phone:** +886-2-28267315 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Yi-Fung Lin **Phone:** +886-958080852 **Role:** CONTACT #### Locations **Location 1:** **City:** Taipei **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** I-Ching Hou - **Phone:** +886-2-28267315 - **Role:** CONTACT **Country:** Taiwan **Facility:** National Yang Ming Chiao Tung University **Zip:** 112 #### Overall Officials **Official 1:** **Affiliation:** National Yang Ming Chiao Tung University **Name:** Associate Professor **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## 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: D000001836 - Term: Body Weight Changes ### 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 ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M5114 - Name: Body Weight - Relevance: HIGH - As Found: Weight - ID: M18102 - Name: Weight Loss - Relevance: HIGH - As Found: Weight Loss - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M5115 - Name: Body Weight Changes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms - ID: D000001835 - Term: Body Weight - ID: D000015431 - Term: Weight Loss ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427460 **Brief Title:** Central-boost Ablative Radiation Therapy for Solid Tumors (CBART) **Official Title:** Central-boost Ablative Radiation Therapy for Large Tumors or Tumors Adjacent to Organs at Risk #### Organization Study ID Info **ID:** Changhai Hospital NMU #### Organization **Class:** OTHER **Full Name:** Changhai Hospital ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-12 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Changhai Hospital #### Responsible Party **Investigator Affiliation:** Changhai Hospital **Investigator Full Name:** Zhang Huo Jun **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** In the case of large tumors or tumors closely adjacent to organs at risk, ablative doses offered by stereotactic body radiation therapy (SBRT) could not be delivered. Therefore, a technique that could provide high radiation doses to tumors without increasing of risks of severe adverse effects is required. **Detailed Description:** Regarding the advanced stage tumor, especially tumors with large volumes or closely adjacent to organs at risk, patients are not candidates for surgical resection. Therefore, raduitherapy may be the optimal local therapy to ameliorate symptoms and be combined with systemic therapy, including chemotherapy, targeted therapy or immunotherapy. However, for those tumors, ablative doses could not be given due to large volumes and abutting to organs at risk. In order to solve the problem, spatially fractionated radiation therapy (SFRT) is used. In details, it was performed based on grid or lattice, which creates several cylindrical high-radiation-dose areas in tumors. Nevertheless, the ablative dose areas are limited albeit with SFRT, which may not greatly improve tumor local. Hence, we create an inner and complete inner gross tumor volume that would be delivered ablative radiation doses, which is named as central-boost ablative radiation therapy (CBART). We aim to investigate the efficacy and safety of CBART in large tumors or tumors adjacent to organs at risk. ### Conditions Module **Conditions:** - Pancreatic Cancer **Keywords:** - pancreatic cancer - stereotactic body radiation therapy - inner gross tumor volume - central boost - ablative radiation dose ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 67 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Central-boost ablative doses delivered by SBRT. **Intervention Names:** - Radiation: Central-boost ablative dose delivered by stereotactic body radiation therapy **Label:** stereotactic body radiation therapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - stereotactic body radiation therapy **Description:** An inner and complete gross tumor volume (iGTV) is created within the gross tumor volume (GTV). For the liver or lung tumor, the convetional radiation dose is 35-45Gy/5f. Regarding the pancreatic tumor or retroperitoneal tumor, the radiation dose is 30-40Gy/5f. Hence, the radiation dose of iGTV should not be less than 120% of the dose of GTV. **Name:** Central-boost ablative dose delivered by stereotactic body radiation therapy **Type:** RADIATION ### Outcomes Module #### Primary Outcomes **Description:** The proportion of patients without tumor local progression at one year. The progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1), 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:** One-year local control will be determined. **Time Frame:** 1 year #### Secondary Outcomes **Description:** The time from the enrollment to death. **Measure:** Overall survival will be determined. **Time Frame:** 2 years **Description:** The time from the enrollment to documentation of any clinical or radiological disease progression or death, whichever occurred first. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1), 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 will be determined. **Time Frame:** 2 years **Description:** Treatment-related adverse effects are determined by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0. **Measure:** Treatment related adverse events **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged 18-75 years. * Pathologically confirmed lung, liver, pancreas or retroperitoneal malignant tumor. * Oligometastasis in the case of metastatic tumor * the shortest diameter ≥2cm or the distance from the tumor to the organs at risk less than 5mm * ECOG of 0 to 1 point * No abnormality in blood routine test, liver and kidney function test and coagulation test (White blood cell count ≥4.0×10\^9/L, neutrophil count ≥2.0×10\^9, hemoglobin level ≥100g/L, platelet count ≥100×10\^9/L, ALT and AST level \< 2.5 times the upper limit of normal, total bilirubin and creatinine level within the normal, international normalized ratio \<2) Exclusion Criteria: * History of radiotherapy for the lesion * History of tumor within 5 years * ECOG ≥2 points * Significant abnormality in blood routine test, liver and kidney function test and coagulation test * Active inflammatory bowel disease in the case of pancreas or retroperitoneal tumor * Gastrointestinal bleeding or perforation within 6 months in the case of pancreas or retroperitoneal tumor * Infections required antibiotics * Heart or respiratory insufficiency * Pregnant or breastfeeding women **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Xiaofei Zhu **Phone:** 86-021-31162222 **Role:** CONTACT #### Locations **Location 1:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Xiaofei Zhu - **Phone:** 86-021-31162222 - **Role:** CONTACT ***Contact 2:*** - **Name:** Huojun Zhang, M.D. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** Huojun Zhang **State:** Shanghai **Status:** RECRUITING **Zip:** 200433 #### Overall Officials **Official 1:** **Affiliation:** Changhai Hospital **Name:** Huojun Zhang, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000004066 - Term: Digestive System Diseases - 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: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13110 - Name: Pancreatic Neoplasms - Relevance: HIGH - As Found: Pancreatic Cancer - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - 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: T4387 - Name: Pancreatic Cancer - Relevance: HIGH - As Found: Pancreatic Cancer ### Condition Browse Module - Meshes - ID: D000010190 - Term: Pancreatic Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: Hemat - Name: Hematinics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427447 **Acronym:** ADJUPANC **Brief Title:** Adjuvant Chemoradiotherapy Versus Chemotherapy for Pancreatic Cancer (ADJUPANC) **Official Title:** Adjuvant Chemoradiotherapy Versus Chemotherapy for Post-operative Pancreatic Cancer #### Organization Study ID Info **ID:** CH hospital #### Organization **Class:** OTHER **Full Name:** Changhai Hospital ### Status Module #### Completion Date **Date:** 2029-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2028-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-12 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Changhai Hospital #### Responsible Party **Investigator Affiliation:** Changhai Hospital **Investigator Full Name:** Zhang Huo Jun **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** In this trial, we aim to compare the outcomes of adjuvant chemoradiotherapy with chemotherapy for patients with resected pancreatic cancer who are at high risk of disease progressions. **Detailed Description:** Pancreatic cancer is a lethal malignancy with the lowest 5-year overall survival rate of 9% and an increasing incidence. In China, the mortality of pancreatic cancer ranked the sixth among all cancers. Although surgical resection is the only radical treatment, only less than 20% patients could receive upfront surgery at the initial diagnosis. Even though patients have surgery, the incidence of disease progressions, including local progression and metastasis, is about 80-90%. In NCCN guidelines and Chinese guidelines, adjuvant chemotherapy is recommended for post-operative pancreatic cancer, while adjuvant chemoradiotherapy could also be used. However, it has not been clarified that which patients may benefit from adjuvant chemoradiotherapy, and no high-level evidence has shown the advantages of adjuvant chemoradiotherapy over chemotherapy. In meta-analyses, it was demonstrated that patients with lymph nodes metastases, R1 or R2 resection or lymphovascular invasion could achieve longer survival after adjuvant chemoradiotherapy compared with chemotherapy. Therefore, we aim to compare the outcomes of adjuvant chemoradiotherapy with those of chemotherapy in patients with lymph nodes metastases, R1 or R2 resection or lymphovascular invasion after surgical resection of pancreatic cancer. ### Conditions Module **Conditions:** - Pancreatic Cancer **Keywords:** - pancreatic cancer - adjuvant chemoradiotherapy - adjuvant chemotherapy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 770 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Chemotherapy: Gemcitabine plus capecitabine Gemcitabine, 1000mg/m2，d1, 8, every 3 weeks as a cycle. Capecitabine, 825-1000mg/m2，bid, d1-14, every 3 weeks as acycle. A total of 6 cycle should be delivered. Chemoradiotherapy: 2-3 weeks after chemotherapy, adjuvant chemoradiotherapy is given. Radiation dose: 50-54Gy (1.8-2.0Gy per fraction). Concurrent capecitabine, 825mg/m2，bid. **Intervention Names:** - Combination Product: Adjuvant chemoradiotherapy **Label:** adjuvant chemoradiotherapy **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Gemcitabine, 1000mg/m2，d1, 8, every 3 weeks as a cycle. Capecitabine, 825-1000mg/m2，bid, d1-14, every 3 weeks as acycle. A total of 6 cycle should be delivered. **Intervention Names:** - Drug: Adjuvant chemotherapy **Label:** adjuvant chemotherapy **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - adjuvant chemoradiotherapy **Description:** Upfront chemotherapy (gemcitabine plus capecitabine) followed chemoradiotherapy (radiotherapy with concurrent capecitabine) **Name:** Adjuvant chemoradiotherapy **Type:** COMBINATION_PRODUCT #### Intervention 2 **Arm Group Labels:** - adjuvant chemotherapy **Description:** Chemotherapy (gemcitabine plus capecitabine) **Name:** Adjuvant chemotherapy **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The time from the start of treatment until documentation of any clinical or radiological disease progression or death, whichever occurred first. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1), 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:** Disease progression free survival will be determined. **Time Frame:** 3 years #### Secondary Outcomes **Description:** The time from the randomization to death. **Measure:** Overall survival will be determined. **Time Frame:** 3 years **Description:** Treatment-related adverse effects are determined by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0. **Measure:** Treatment-related adverse events will be determined. **Time Frame:** 3 years **Description:** The analysis of quality of life is based on European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30). All scales and subscales range from 0 to 100. Regarding physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning and global health, higher scores may indicate better outcomes. In the case of fatigue, nausea and vomitting, pain, dyspnea, insomina, appetite loss, constipation, diarrhea and financial difficulties, lower scores may indicate better outcomes. Scales of all items are independent and not combined to compute a total score. **Measure:** Quality of life will be determined. **Time Frame:** 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged 18-75 years * Pathologically confirmed pancreatic ductal adenocarcinoma * Pathologically confirmed lymph node metastasis, R1 or R2 resection or perineural or lymphovascular invasion (one of the risk factors) * No history of cancer treatment after surgical resection * No disease progression confirmed by imaging examinations * ECOG 0 to1 point * No abnormality in blood routine test, liver and kidney function test and coagulation test (White blood cell count ≥4.0×10\^9/L, neutrophil count ≥2.0×10\^9, hemoglobin level ≥100g/L, platelet count ≥100×10\^9/L, ALT and AST level \< 2.5 times the upper limit of normal, total bilirubin and creatinine level within the normal, international normalized ratio \<2) Exclusion Criteria: * History of cancer treatment after surgical resection * History of other cancers within 5 years * Disease progression, including local pprogression or metastasis, confirmed by imaging examinations * ECOG ≥2 points * Significant abnormality in blood routine test, liver and kidney function test and coagulation test * Active inflammatory bowel disease * Gastrointestinal bleeding or perforation within 6 months * Infections requiring antibiotics * Heart or respirotory insufficiency * Pregnant women or breastfeeding women **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Xiaofei Zhu **Phone:** 86-021-31162222 **Role:** CONTACT #### Locations **Location 1:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Xiaofei Zhu, M.D. - **Phone:** 86-021-31162222 - **Role:** CONTACT ***Contact 2:*** - **Name:** Huojun Zhang, M.D. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** Huojun Zhang **State:** Shanghai **Status:** RECRUITING **Zip:** 200433 #### Overall Officials **Official 1:** **Affiliation:** Changhai Hospital **Name:** Huojun Zhang, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000004066 - Term: Digestive System Diseases - 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: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13110 - Name: Pancreatic Neoplasms - Relevance: HIGH - As Found: Pancreatic Cancer - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - 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: T4387 - Name: Pancreatic Cancer - Relevance: HIGH - As Found: Pancreatic Cancer ### Condition Browse Module - Meshes - ID: D000010190 - Term: Pancreatic Neoplasms ### 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: LOW - As Found: Unknown - ID: M377 - Name: Capecitabine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427434 **Brief Title:** Effect of Modified Lumbar Sustained Natural Apophyseal Glide on Postnatal Low Back Pain **Official Title:** Effect of Modified Lumbar Sustained Natural Apophyseal Glide on Low Back Pain in Postnatal Women #### Organization Study ID Info **ID:** P.T.REC/012/004494 #### Organization **Class:** OTHER **Full Name:** Cairo University ### Status Module #### Completion Date **Date:** 2024-08-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-07-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cairo University #### Responsible Party **Investigator Affiliation:** Cairo University **Investigator Full Name:** Mina Nageib Soliman **Investigator Title:** Principal investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study will be carried out to evaluate the effect of modified lumbar Sustained Natural Apophyseal Glide on low back pain in postnatal women. **Detailed Description:** In fact, up to 75% of women who suffer from pregnancy-related back pain may continue to have pain after giving birth. Women who experience LBP or pelvic girdle pain (PGP) at 3 months postpartum were found to be at higher risk for persistent or chronic LBP. Of these women, only 6% recover within 6-18 months after giving birth. A modified lumbar Sustained Natural Apophyseal Glide (SNAG) is an existing Mulligan mobilization technique performed with a combination of joint glide and physiological spinal movement. The glide can be applied to the spinous processes, facets, or unilaterally over the transverse processes while the patient performs the active exercise. Few studies have been concerned with the effects of modified "SNAGS" on the lumbar spine . So, this study will be done to investigate its effect on low back pain in postnatal women aiming to improve their function to accomplish their daily living activities and reduce the side effects of medical treatment. ### Conditions Module **Conditions:** - Low Back Pain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The participants will be asked to perform strengthening and stretching exercises to the back and abdominal muscles for 30 min, three times per week for 4 weeks. **Intervention Names:** - Other: Strengthening and stretching exercises to the back and abdominal muscles **Label:** Strengthening and stretching exercises **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** The participants will receive Modified Sustained Natural Apophyseal Glide on the affected lumbar level for 30 sec three times per week for 4 weeks. In addition to strengthening and stretching exercises to the back and abdominal muscles for 30 min, three times per week for 4 weeks **Intervention Names:** - Other: Strengthening and stretching exercises to the back and abdominal muscles - Other: Modified Lumbar Sustained Natural Apophyseal Glide **Label:** Modified Lumbar Sustained Natural Apophyseal Glide **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Modified Lumbar Sustained Natural Apophyseal Glide - Strengthening and stretching exercises **Description:** Strengthening and stretching exercises to the back and abdominal muscles will be performed for 30 min, three times per week for 4 weeks. **Name:** Strengthening and stretching exercises to the back and abdominal muscles **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Modified Lumbar Sustained Natural Apophyseal Glide **Description:** Modified Sustained Natural Apophyseal Glide will be applied on the affected lumbar level for 30 sec three times per week for 4 weeks. **Name:** Modified Lumbar Sustained Natural Apophyseal Glide **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The visual analogue scale is a 10 cm calibrated line with 0 representing no pain and 10 representing the worst pain; will be used to assess the severity of pain before and after treatment for all participants in both groups. **Measure:** Pain intenesity **Time Frame:** within 4 weeks **Description:** The modified Schober test will be used to measure the lumbar flexion range of motion (ROM) by using the tape measurement. Each participant will be asked to stand erect with her feet about shoulder-width apart to stabilize the pelvis. Then, the posterior superior iliac spines(PSIS) will be determined by the therapist's both thumbs, and then an ink line will be drawn along the midline of the lumbar spines horizontal to the PSIS to mark the midpoint between the two PSIS. Then tape will be used to identify and mark two points: one is 10 cm superior to the midpoint (A), and another is 5 cm inferior to the midpoint (B). The participant will be instructed to bend forward as much as she can while keeping both knees straight, the new distance between superior and inferior skin marking will be measured in centimeters. The increased distance along the tape due to lumbar flexion is normally about 6-7 cm (less than 5 cm should be considered abnormal). **Measure:** Lumbar flexion range of motion **Time Frame:** within 4 weeks **Description:** The modified Schober test will be used to measure the lumbar extension range of motion (ROM) by using the tape measurement while the patient is in a standing position. The participant will be instructed to put her hands on her buttocks and bend backward into full lumbar extension and the new distance between the superior and inferior skin markings will be measured in centimeters by the tape measurement. The change in the difference between the marks is used to indicate the amount of lumbar extension. The increased distance along the tape due to the extension of the lumbar spine is normally about 2-3 cm (less than 1 cm should be considered abnormal). **Measure:** Lumbar extension range of motion **Time Frame:** within 4 weeks **Description:** The participant will be asked to stand erect with her feet about shoulder-width apart. Both right and left lateral flexion will be measured by the tape as the distance from the tip of the index finger to the floor at maximal comfortable lateral flexion. The participant will be instructed to bend her trunk laterally as much as she can. The normal value of lateral spinal flexion is 16.2-28.0 cm. **Measure:** Lumbar lateral flexion range of motion **Time Frame:** within 4 weeks #### Secondary Outcomes **Description:** Functional disability will be assessed by the Oswestry Disability Index, it was developed as a clinical valid and reliable assessment tool that would provide an estimate of disability expressed as a percentage score. It is composed of 10 questions and it takes around 5min for a patient to complete. Each of the 10 questions is scored from 0 to 5, giving a maximum score of 50. The total score is then converted into a percentage by multiplying it by 2. Scores are stratified into severity: 0-20, minimal disability; 21-40, moderate disability; 41-60, severe disability; 61-80, crippling back pain; 81-100, bed-bound. A low score = low degree of disability, a high score = high degree of disability. **Measure:** Functional disability **Time Frame:** within 4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. All participants will be diagnosed as chronic postnatal low back pain. 2. Their ages will be ranged from 20 to 35 years old. 3. Their body mass index (BMI) will not exceed 30 kg/m2. 4. All participants have the same social level. 5. All participants have the same lifestyle. 6. Their number of parity will be ranged from 2-4 children. Exclusion Criteria: 1. Spinal fracture or any other neurological disorders. 2. Lumbar spinal stenosis from lumbar disc herniation, degenerative joint diseases, or spondylolisthesis. 3. Women with BMI \> 30 kg/m2. 4. Participants who had pelvic pathology. 5. Skin disease interferes with mobilization application. 6. Gynecological diseases (chronic pelvic pain, uterine prolapse and retroversion flexion of the uterus). **Healthy Volunteers:** True **Maximum Age:** 35 Years **Minimum Age:** 20 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Mina soliman, PHD **Phone:** 01283605551 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Afaf Botla, Assistant professor **Phone:** 01283126608 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Cairo University **Name:** Azza Kassab, professor **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES ## 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 ### Condition Browse Module - Browse Leaves - ID: M4714 - Name: Back Pain - Relevance: HIGH - As Found: Back Pain - ID: M19433 - Name: Low Back Pain - Relevance: HIGH - As Found: Low Back Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001416 - Term: Back Pain - ID: D000017116 - Term: Low Back Pain ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427421 **Acronym:** CARegT1D **Brief Title:** Characterization of Autoreactive Regulatory and Conventional CD4 T Cells in Recent Onset Type 1 Diabetes and Control Individuals **Official Title:** Characterization of Autoreactive Regulatory and Conventional CD4 T Cells in Recent Onset Type 1 Diabetes and Control Individuals #### Organization Study ID Info **ID:** APHP230664 #### Organization **Class:** OTHER **Full Name:** Assistance Publique - Hôpitaux de Paris #### Secondary ID Infos **Domain:** ID-RCB **ID:** 2024-A00696-41 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2026-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-16 ### 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 ### Description Module **Brief Summary:** Type 1 diabetes (T1D) is caused by an autoimmune response leading to the destruction of pancreatic beta cells. The disease association with particular HLA class II alleles, particularly HLA-DQ8, indicates the implication of CD4 T cells in its aetiology. The hypothesis is therefore that T1D starts by the loss of tolerance in autoreactive CD4 T cells. This might result from alterations in conventional autoreactive CD4 T cells (Tcons), which drive disease, or autoreactive regulatory CD4 T cells expressing the transcription factor FOXP3 (Tregs), which normally maintain immune tolerance. The investigators expect that the characterization of HLA-DQ8-restricted Tcons and Tregs in recent onset HLA-DQ8+ T1D patients shall shed light on the molecular mechanisms underpinning T1D development. This knowledge will guide the development of novel cell therapies harnessing the power of genetically engineered Tregs expressing the relevant antigen receptor to restore immune homeostasis upon cell transfer. The ultimate goal is to reach a curative effect **Detailed Description:** During the development of type 1 diabetes (T1DM), regulatory T cells (Treg) are modified and their protective role is no longer optimal, particularly against pathology-specific autoreactive antigens. The hypothesis is that in patients with T1DM, the function and phenotype of Treg cells, as well as their receptor repertoire for the antigen to which they are specific (TCR), no longer allow them to control tolerance. The in-depth study of these cells, at both genetic and molecular levels, will enable a major breakthrough in our understanding of the pathophysiology of T1DM, and in the development of targeted cell therapy. The investigators expect major/important differences between patient Tregs and those of the control population in this study, at the molecular, phenotypic and functional levels. These differences will highlight the TCRs recognizing the target self-antigens. In this way, investigators expect to be able to select a limited number of Treg TCRs that could ultimately be used in cell therapy to restore the protective role of Tregs in these patients. Thus, this knowledge will enable to propose in the future a more effective immunotherapy with a long-term effect, in order to improve the management of patients with autoimmune diabetes and potentially cure them. Accordingly, yhe investigators will study insulin-specific Tregs in T1DM patients and control individuals, as well as conventional T cells directed against the same antigen, which in patients are implicated in the disease. This will include a study of their functional status, their transcriptomic profile, as well as their TCRs and their fine recognition properties of the major diabetes self-antigen, insulin. ### Conditions Module **Conditions:** - Type 1 Diabetes **Keywords:** - Type 1 Diabetes - Regulatory T cells - Pathophysiology of T1DM ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** children aged 6 to under 18 on the day of inclusion, with a recent diagnosis of type 1 diabetes **Intervention Names:** - Biological: Frequency of Treg and Teffs - Biological: Phenotype of Treg and Teffs - Biological: RNA seq analysis - Biological: HLA typing - Biological: beta-cell autoantibody dosage **Label:** Newly diagnosed T1DM group **Type:** OTHER #### Arm Group 2 **Description:** children aged 6 to under 18 on the day of inclusion, with no history of type 1 diabetes **Intervention Names:** - Biological: Frequency of Treg and Teffs - Biological: Phenotype of Treg and Teffs - Biological: RNA seq analysis - Biological: HLA typing - Biological: beta-cell autoantibody dosage - Biological: Glycated haemoglobin (HbA1C) dosage - Biological: blood glucose dosage - Biological: C-peptide dosage **Label:** Control group **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Control group - Newly diagnosed T1DM group **Description:** additionnal blood sampling at inclusion **Name:** Frequency of Treg and Teffs **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Control group - Newly diagnosed T1DM group **Description:** additionnal blood sampling at inclusion **Name:** Phenotype of Treg and Teffs **Type:** BIOLOGICAL #### Intervention 3 **Arm Group Labels:** - Control group - Newly diagnosed T1DM group **Description:** additionnal blood sampling at inclusion **Name:** RNA seq analysis **Type:** BIOLOGICAL #### Intervention 4 **Arm Group Labels:** - Control group - Newly diagnosed T1DM group **Description:** additionnal blood sampling at inclusion **Name:** HLA typing **Type:** BIOLOGICAL #### Intervention 5 **Arm Group Labels:** - Control group - Newly diagnosed T1DM group **Description:** additionnal blood sampling at inclusion **Name:** beta-cell autoantibody dosage **Type:** BIOLOGICAL #### Intervention 6 **Arm Group Labels:** - Control group **Description:** additionnal blood sampling at inclusion **Name:** Glycated haemoglobin (HbA1C) dosage **Type:** BIOLOGICAL #### Intervention 7 **Arm Group Labels:** - Control group **Description:** additionnal blood sampling at inclusion **Name:** blood glucose dosage **Type:** BIOLOGICAL #### Intervention 8 **Arm Group Labels:** - Control group **Description:** additionnal blood sampling at inclusion **Name:** C-peptide dosage **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** study the frequency and phenotype of insulin-specific autoreactive Tregs lymphocytes among CD4+ T lymphocytes in children with T1DM and compare these values with those of controls. These parameters will be analyzed by flow cytometry using immune cells from blood samples taken from the T1DM and control groups. **Measure:** Frequency and phenotype of Tregs **Time Frame:** Within 4 weeks of T1DM diagnosis #### Secondary Outcomes **Description:** Description : the HLA of T1DM and controls will be analyzed by qPCR. This will make it possible to associate the results obtained during the analysis of the main criteria with the HLA of each individual. **Measure:** HLA testing **Time Frame:** Within 4 weeks of T1DM diagnosis **Description:** Insulin-specific Tregs and Teffs cells will be isolated by flow cytometry **Measure:** Isolate insulin-specific Tregs and Teffs cells **Time Frame:** Within 4 weeks of T1DM diagnosis **Description:** their transcriptome and TCR will be determined by single-cell transcriptomics analysis (scRNAseq). **Measure:** Treg and Teffs transcriptome **Time Frame:** Within 4 weeks of T1DM diagnosis **Description:** Following flow cytometry, the different repertoires will be compared between the DT1 and control groups. **Measure:** Full TCR repertoire of Tregs and Teffs **Time Frame:** Within 4 weeks of T1DM diagnosis **Description:** Machine learning analysis of the data obtained (TCR, transcriptome, frequency and phenotype of insulin-specific Tregs and Teffs) to predict the relationship between TCR and functional properties of Tregs and Teffs in patients and controls **Measure:** Machine learning analysis **Time Frame:** Within 4 weeks of T1DM diagnosis ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Newly diagnosed T1DM group: * Age ≥ 6 years and \< 18 years on day of inclusion; * Weight ≥ 12 kg; * Newly diagnosed T1DM, diagnosis defined according to International Society of Pediatric and Adolescent Diabetes (ISPAD) criteria by: hyperglycemia \> 2g/L and/or ketonemia and/or polyuro-polydipsia and/or weight loss ; * Absence of other associated inflammatory or autoimmune diseases; * Affiliation with a health insurance scheme or beneficiary (excluding AME); * Written consent of parental guardians; * Ability to understand and read French. Control group : * Age ≥ 6 years and \< 18 years on the day of inclusion; * Weight ≥ 12 kg; * No personal history of T1DM; * Affiliation with a health insurance scheme or entitled person (excluding AME); * Written consent from parental guardians; * Ability to understand and read French. Exclusion Criteria: Newly diagnosed T1DM group: * Use of corticosteroids in the month prior to blood sampling * Contraindication to the use of anaesthetic cream for blood sampling. Control group : * History of autoimmune or inflammatory disease * Use of corticosteroids in the month preceding blood sampling * Contraindication to the use of anaesthetic cream for blood sampling **Maximum Age:** 18 Years **Minimum Age:** 6 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jacques BELTRAND, MD, PhD **Phone:** +33 1 40 61 53 20 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Laure CHOUPEAUX, MSc **Phone:** + 33 1 44 38 17 11 **Role:** CONTACT #### Locations **Location 1:** **City:** Paris **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jacques BELTRAND, MD, PhD - **Phone:** +33 1 40 61 53 20 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Laure CHOUPEAUX, MSc - **Phone:** + 33 1 44 38 17 11 - **Role:** CONTACT ***Contact 3:*** - **Name:** Jacques BELTRAND, MD, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** Hôpital Necker Enfants Malades **Zip:** 75015 #### Overall Officials **Official 1:** **Affiliation:** Institut National de la Santé Et de la Recherche Médicale, France **Name:** Simon FILATREAU, PhD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Patterson CC, Harjutsalo V, Rosenbauer J, Neu A, Cinek O, Skrivarhaug T, Rami-Merhar B, Soltesz G, Svensson J, Parslow RC, Castell C, Schoenle EJ, Bingley PJ, Dahlquist G, Jarosz-Chobot PK, Marciulionyte D, Roche EF, Rothe U, Bratina N, Ionescu-Tirgoviste C, Weets I, Kocova M, Cherubini V, Rojnic Putarek N, deBeaufort CE, Samardzic M, Green A. 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N Engl J Med. 2005 Jun 23;352(25):2598-608. doi: 10.1056/NEJMoa043980. **PMID:** 15972866 **Citation:** Vignali DA, Collison LW, Workman CJ. How regulatory T cells work. Nat Rev Immunol. 2008 Jul;8(7):523-32. doi: 10.1038/nri2343. **PMID:** 18566595 **Citation:** Corthay A. How do regulatory T cells work? Scand J Immunol. 2009 Oct;70(4):326-36. doi: 10.1111/j.1365-3083.2009.02308.x. **PMID:** 19751267 **Citation:** Visperas A, Vignali DA. Are Regulatory T Cells Defective in Type 1 Diabetes and Can We Fix Them? J Immunol. 2016 Nov 15;197(10):3762-3770. doi: 10.4049/jimmunol.1601118. **PMID:** 27815439 **Citation:** Bluestone JA, Buckner JH, Fitch M, Gitelman SE, Gupta S, Hellerstein MK, Herold KC, Lares A, Lee MR, Li K, Liu W, Long SA, Masiello LM, Nguyen V, Putnam AL, Rieck M, Sayre PH, Tang Q. Type 1 diabetes immunotherapy using polyclonal regulatory T cells. Sci Transl Med. 2015 Nov 25;7(315):315ra189. doi: 10.1126/scitranslmed.aad4134. **PMID:** 26606968 **Citation:** Marek-Trzonkowska N, Mysliwiec M, Dobyszuk A, Grabowska M, Techmanska I, Juscinska J, Wujtewicz MA, Witkowski P, Mlynarski W, Balcerska A, Mysliwska J, Trzonkowski P. Administration of CD4+CD25highCD127- regulatory T cells preserves beta-cell function in type 1 diabetes in children. Diabetes Care. 2012 Sep;35(9):1817-20. doi: 10.2337/dc12-0038. Epub 2012 Jun 20. **PMID:** 22723342 **Citation:** Dong S, Hiam-Galvez KJ, Mowery CT, Herold KC, Gitelman SE, Esensten JH, Liu W, Lares AP, Leinbach AS, Lee M, Nguyen V, Tamaki SJ, Tamaki W, Tamaki CM, Mehdizadeh M, Putnam AL, Spitzer MH, Ye CJ, Tang Q, Bluestone JA. The effect of low-dose IL-2 and Treg adoptive cell therapy in patients with type 1 diabetes. JCI Insight. 2021 Sep 22;6(18):e147474. doi: 10.1172/jci.insight.147474. **PMID:** 34324441 **Citation:** Kieback E, Hilgenberg E, Stervbo U, Lampropoulou V, Shen P, Bunse M, Jaimes Y, Boudinot P, Radbruch A, Klemm U, Kuhl AA, Liblau R, Hoevelmeyer N, Anderton SM, Uckert W, Fillatreau S. Thymus-Derived Regulatory T Cells Are Positively Selected on Natural Self-Antigen through Cognate Interactions of High Functional Avidity. Immunity. 2016 May 17;44(5):1114-26. doi: 10.1016/j.immuni.2016.04.018. **PMID:** 27192577 **Citation:** Krischer JP; Type 1 Diabetes TrialNet Study Group. The use of intermediate endpoints in the design of type 1 diabetes prevention trials. Diabetologia. 2013 Sep;56(9):1919-24. doi: 10.1007/s00125-013-2960-7. Epub 2013 Jun 7. **PMID:** 23744306 **Citation:** Noble JA. Immunogenetics of type 1 diabetes: A comprehensive review. J Autoimmun. 2015 Nov;64:101-12. doi: 10.1016/j.jaut.2015.07.014. Epub 2015 Aug 10. **PMID:** 26272854 **Citation:** Caillat-Zucman S, Garchon HJ, Timsit J, Assan R, Boitard C, Djilali-Saiah I, Bougneres P, Bach JF. Age-dependent HLA genetic heterogeneity of type 1 insulin-dependent diabetes mellitus. J Clin Invest. 1992 Dec;90(6):2242-50. doi: 10.1172/JCI116110. **PMID:** 1469084 #### See Also Links **Label:** Related Info **URL:** https://diabetesatlas.org/data/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune 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 - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes - ID: M7117 - Name: Diabetes Mellitus, Type 1 - Relevance: HIGH - As Found: Type 1 Diabetes - 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 - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003922 - Term: Diabetes Mellitus, Type 1 ### Intervention Browse Module - Ancestors - ID: D000000894 - Term: Anti-Inflammatory Agents, Non-Steroidal - ID: D000018712 - Term: Analgesics, Non-Narcotic - 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: D000000893 - Term: Anti-Inflammatory Agents - ID: D000018501 - Term: Antirheumatic Agents - ID: D000007155 - Term: Immunologic Factors ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Analg - Name: Analgesics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M207501 - Name: Chrysarobin - Relevance: HIGH - As Found: Aorta - ID: M4625 - Name: Autoantibodies - Relevance: HIGH - As Found: Pericardium - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M4218 - Name: Anti-Inflammatory Agents, Non-Steroidal - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M20786 - Name: Analgesics, Non-Narcotic - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000013883 - Term: Chrysarobin - ID: D000001323 - Term: Autoantibodies ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427408 **Acronym:** VilliRNAseq **Brief Title:** Longitudinal Study of Gene Expression in the Human Placenta During First-trimester and Full-term Pregnancy at the Single Cell Level **Official Title:** Cellular Transcriptomic Trajectory of the Human Placenta During Pregnancy #### Organization Study ID Info **ID:** APHP240045 #### Organization **Class:** OTHER **Full Name:** Assistance Publique - Hôpitaux de Paris #### Secondary ID Infos **Domain:** France : Ministry of Health **ID:** 2022-A02452-41 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2027-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-02 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Institut National de la Santé Et de la Recherche Médicale, France #### 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:** The single nucleus RNA-seq approach allows the placental transcriptome to be analyzed from nuclei, thus preserving the integrity of placental syncytium. This approach is feasible on small fragments of villi and offers for the first time the possibility to consider the characterization of gene expression within the structural unit of the human placenta during pregnancy (at the 1st trimester and childbirth) **Detailed Description:** Chorionic villus biopsies are routinely performed between 11SA and 15SA at the Fetal Medicine Unit́ of the Port-Royal Maternity Hospital (CPDPN Cochin) after the patient has signed an information and consent form for the genetic analysis. The patient will be asked to participate to the VilliRNAseq project and will sign the consent form of the study. After the cytogeneticist observation, a villi fragment will be snap-frozen in liquid nitrogen and stored at -80°C until use. Each patient sampled in the first trimester is followed until the end of the pregnancy. At delivery, cesarean section or vaginal delivery, a placental sample will be snap-frozen in liquid nitrogen and stored at -80°C until use. Isolation, sorting and encapsidation of nuclei, RNA libraries preparation and sequencing will be carried out using 10x Genomics technology. State-of-the-art computational analyses to decipher trajectories and cell-to-cell communications. ### Conditions Module **Conditions:** - Pregnancy Related **Keywords:** - Placenta - Single nuclei RNA-seq - Preeclampsia - Pregnancy outcomes ### Design Module #### Bio Spec **Description:** Placental tissue **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** There is only one study group : patients with placental transcriptomic analysis by single nucleus RNA-seq approach **Intervention Names:** - Other: Non applicable **Label:** Villi RNASeq ### Interventions #### Intervention 1 **Arm Group Labels:** - Villi RNASeq **Description:** Placental transcriptomic analysis **Name:** Non applicable **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Sequencing data will be analysed at the Institut Cochin, cell trajectories will be modelled and intracellular communications will be inferred **Measure:** Analysis of the cellular transcriptomic trajectory of the human placenta **Time Frame:** Day 0 **Description:** Sequencing data will be analysed at the Institut Cochin, cell trajectories will be modelled and intracellular communications will be inferred **Measure:** Analysis of the cellular transcriptomic trajectory of the human placenta **Time Frame:** At childbirth #### Secondary Outcomes **Measure:** Collection of placental samples **Time Frame:** Day 0 **Measure:** Collection of placental samples **Time Frame:** At childbirth **Description:** Pre-eclampsia, growth retardation in utero, delivery before 37 SA **Measure:** Identification of early markers of pregnancy complications **Time Frame:** Until at Childbirth ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 18 to 50 * Progressive monofoetal pregnancy between 11 and 15 weeks of amenorrhea * Patient with prenatal medical indication and requesting chorionic villus biopsy with cytogenetic analysis or molecular genetics * Patient scheduled for delivery at Port-Royal Maternity Hospital Exclusion Criteria: * Minor patient * Multiple pregnancy * Patient's objection * Without health insurance * Patient under guardianship or curatorship **Gender Based:** True **Gender Description:** Pregnancy **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT **Study Population:** Women in their pregnancy follow-up at the Maternité Port-Royal-Cochin ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Vassilis TSATSARIS, MD PHD **Phone:** 00331 58 41 38 71 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Marie BENHAMMANI-GODARD **Phone:** 0033158411190 **Role:** CONTACT #### Locations **Location 1:** **City:** Paris **Contacts:** ***Contact 1:*** - **Name:** Hélène COLLINOT, MD - **Phone:** 0033 1 58 41 38 19 - **Role:** CONTACT **Country:** France **Facility:** Maternité Port-Royal, Cochin hospital **State:** IDF **Zip:** 75014 #### Overall Officials **Official 1:** **Affiliation:** Institut National de la Santé Et de la Recherche Médicale, France **Name:** Céline MÉHATS, PHD **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** APHP **Name:** Hélène COLLINOT, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### 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: M14106 - Name: Pre-Eclampsia - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427395 **Brief Title:** Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis **Official Title:** A Multicenter, Open-Label, Extension Clinical Trial to Evaluate Safety and Efficacy of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis (PBC) #### Organization Study ID Info **ID:** SARO.23.002 #### Organization **Class:** INDUSTRY **Full Name:** Zydus Therapeutics Inc. ### Status Module #### Completion Date **Date:** 2027-07-18 **Type:** ESTIMATED #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-30 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-04-18 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Zydus 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:** Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis **Detailed Description:** A Multicenter, Open-Label, Extension Clinical trial to evaluate Safety and Efficacy of Saroglitazar Magnesium in Participants with Primary Biliary Cholangitis (PBC) ### Conditions Module **Conditions:** - Primary Biliary Cholangitis **Keywords:** - Saroglitazar Magnesium - Primary Biliary Cholangitis - PBC ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Multicenter, Open-Label, phase III, safety and efficacy study ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Saroglitazar Magnesium 1 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (24 months). **Intervention Names:** - Drug: Saroglitazar Magnesium 1 mg **Label:** Saroglitazar Magnesium 1 mg **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Saroglitazar Magnesium 1 mg **Description:** Saroglitazar Magnesium 1 mg will be assigned to all participants enrolled in the open label extension program **Name:** Saroglitazar Magnesium 1 mg **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 **Time Frame:** From baseline to 24 Months/EOT #### Secondary Outcomes **Description:** ALP \< 1.67 x ULN, ≥ 15% decrease in ALP, and total bilirubin ≤ ULN or direct bilirubin ≤ ULN relative to baseline in participants with known Gilbert's syndrome **Measure:** Proportion of participants achieving biochemical response based on the composite endpoints of ALP and total bilirubin **Time Frame:** From baseline to Months 12 and 24/EOT **Description:** complete normalization of ALP. Change and percent change from baseline in ALP **Measure:** Proportion of participants with biochemical response based on the composite endpoints of ALP and total bilirubin **Time Frame:** From baseline to Months 12 and 24/EOT **Description:** Defined as new onset or recurrence of any of the following: * Hospitalization for new onset or recurrence of variceal bleed * Hepatic encephalopathy (as defined by a West Haven score ≥2) * New onset ascites requiring treatment * Refractory ascites (requiring large volume paracentesis) * Spontaneous bacterial peritonitis (confirmed by culture from diagnostic paracentesis) **Measure:** Time to occurrence of the clinical outcome events in study participants with PBC **Time Frame:** From baseline to 24 Months/EOT **Description:** Time from enrolment to the first occurrence of Model for End Stage Liver Disease 3.0 score ≥ 15 and 25% increase from baseline as measured on 2 consecutive occasions performed at least two weeks apart with no competing etiologies identified **Measure:** Time to occurrence of the clinical outcome events based on Model for End Stage Liver Disease 3.0 score **Time Frame:** From baseline to 24 Months/EOT **Measure:** Time to first occurrence of Liver transplant or placement on a liver transplant list **Time Frame:** From baseline to 24 Months/EOT **Description:** Death (liver and non-liver related) **Measure:** Time to the occurrence of Death **Time Frame:** From baseline to 24 Months/EOT **Description:** Change from baseline in ALT **Measure:** Effect on liver enzyme parameters **Time Frame:** From baseline to Months 12 and 24/EOT **Description:** Change from baseline in AST **Measure:** Effect on liver enzyme parameters **Time Frame:** From baseline to Months 12 and 24/EOT **Description:** Change from baseline in GGT **Measure:** Effect on liver enzyme parameters **Time Frame:** From baseline to Months 12 and 24/EOT **Description:** Change from baseline in total bilirubin **Measure:** Effect on liver enzyme parameters **Time Frame:** From baseline to Months 12 and 24/EOT **Description:** Change from baseline in TG **Measure:** Effect on lipid parameters **Time Frame:** From baseline to Months 12 and 24/EOT **Description:** Change from baseline in LDL-C **Measure:** Effect on lipid parameters **Time Frame:** From baseline to Months 12 and 24/EOT **Description:** Change from baseline in HDL-C **Measure:** Effect on lipid parameters **Time Frame:** From baseline to Months 12 and 24/EOT **Description:** Change from baseline in VLDL-C **Measure:** Effect on lipid parameters **Time Frame:** From baseline to Months 12 and 24/EOT **Description:** Change from baseline in total cholesterol **Measure:** Effect on lipid parameters **Time Frame:** From baseline to Months 12 and 24/EOT **Description:** Change from baseline in non-HDL-C **Measure:** Effect on lipid parameters **Time Frame:** From baseline to Months 12 and 24/EOT **Description:** Change from baseline in serum bile acids **Measure:** Effect on liver enzyme parameters **Time Frame:** From baseline to Months 12 and 24/EOT **Description:** Change from baseline in quality of life (Primary Biliary Cholangitis- 40) questionnaire domains Scale as Never, Rarely, Sometimes, Most of the time, and Always **Measure:** Effect on disease-related symptoms **Time Frame:** From baseline to Months 12 and 24/EOT **Description:** Change from baseline in 5-D itch scale Score ranging from 5 to 25, where higher score represents worst itching **Measure:** Effect on disease-related symptoms **Time Frame:** From baseline to Months 12 and 24/EOT **Description:** Change from baseline in Worst Itch NRS (numerical rating scale) scores 0-10, where 0 is no itch and 10 is worst itch imaginable **Measure:** Effect on disease-related symptoms **Time Frame:** From baseline to Months 12 and 24/EOT **Description:** Change from baseline in LSM assessed by Liver elastography/FibroScan **Measure:** Effect on liver stiffness measurement (LSM) assessed by Liver elastography/FibroScan **Time Frame:** From baseline to Months 12 and 24/EOT ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Must provide written informed consent and agree to comply with the trial protocol 2. Participated and completed SARO.21.001, the double-blind treatment phase study Exclusion Criteria: 1. Consumption of 2 standard drinks per day if male and 1 standard drink per day if female for 3 consecutive months (12 consecutive weeks) throughout double-blind phase till screening. 2. Participants with MELD 3.0 score of 15 or greater 3. History or presence of other concomitant liver diseases at screening: 1. Chronic hepatitis B or C virus (HBV, HCV) infection 2. Primary sclerosing cholangitis (PSC) 3. Alcoholic liver disease 4. Autoimmune hepatitis (AIH)-PBC overlap syndrome 5. Hemochromatosis 6. Non-alcoholic steatohepatitis (NASH) on historical biopsy 4. Cirrhosis with complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma, uncontrolled ascites, encephalopathy, history of variceal bleeding or history of hepatorenal syndrome at screening. 5. Use of Thiazolidinediones or Fibrates (within 12 weeks prior to screening) 6. Use of Obeticholic acid (OCA), methotrexate, budesonide and other systemic corticosteroids (Prednisone dose more than 10 mg); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid, or nitrofurantoin) (within 12 weeks prior to screening) 7. History of bowel surgery (gastrointestinal \[bariatric\] surgery in the preceding 1 year or undergoing evaluation for gastrointestinal surgery (bariatric surgery for obesity, extensive small-bowel resection) or orthotopic liver transplant (OLT) or listed for OLT 8. Unstable cardiovascular disease, including: 1. Unstable angina, (i.e., new or worsening symptoms of coronary heart disease in the 12 weeks before screening and throughout the screening period), acute coronary syndrome in the 24 weeks before screening and throughout the screening period, acute myocardial infarction in the 12 weeks before screening and throughout the screening period or heart failure of New York Heart Association class (III - IV) or worsening congestive heart failure, or coronary artery intervention, in the 24 weeks before screening and throughout the screening period 2. History/current unstable cardiac dysrhythmias 3. Uncontrolled hypertension at screening 4. Stroke or transient ischemic attack in the 24 weeks before screening 9. History of intracranial hemorrhage, arteriovenous malformation, bleeding disorder, and coagulation disorders 10. An uncontrolled thyroid disorder 1. Uncontrolled hyperthyroidism: defined as any history of hyperthyroidism that has either not been treated with either radioactive iodine and/or surgery or that has been treated with radioactive iodine and/or surgery, but has required ongoing continuous or intermittent use of thyroid hormone synthesis inhibitors (i.e., methimazole or propylthiouracil) in the 24 weeks before screening 2. Uncontrolled hypothyroidism: defined as initiation of thyroid hormone replacement therapy or dose adjustment of replacement therapy in the 12 weeks before screening 11. History of myopathies or evidence of active muscle disease demonstrated by CPK ≥ 5 × ULN at screening 12. Any of the following laboratory values: 1. Total bilirubin \> 3 x ULN 2. Platelets \< 50 × 103/mL 3. Albumin \< 2.8 g/dL 4. eGFR \< 45 mL/min/1.73 m2 5. ALT or AST \> 250 U/L x ULN 6. ALP \> 10 × ULN 13. Participation in another interventional clinical study and receipt of any other investigational medication or medical device within 30 days or within 5 half-lives, whatever is longer, prior to screening 14. History of malignancy in the past 5 years and/or active neoplasm which may diminish life expectancy (except resolved superficial non-melanoma skin cancer, carcinomas in situ or other stable, relatively benign conditions if appropriately treated prior to screening) 15. Known allergy, sensitivity or intolerance to the study medication or formulation ingredients 16. Pregnancy-related exclusions, including: 1. Pregnant/lactating female (including positive pregnancy test at screening) 2. Participants agree to avoid pregnancy either by true abstinence or the use of an acceptable effective contraceptive measures for the duration of the study and for at least 1 month after the end of the study medication. Refer Appendix 9 Contraceptive Guidance. 17. History or other evidence of severe illness or any other conditions that would make the participant, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, HIV, coronary artery disease or active gastrointestinal conditions that might interfere with drug absorption) 18. Cirrhosis with Child-Pugh-Turcotte (CPT) class B or C having score of 7 or above at screening (Refer Appendix 11 **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Farheen Shaikh **Phone:** 609-730-1900 **Phone Ext:** 221 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Deven Parmar **Phone:** 609-559-0765 **Role:** CONTACT #### Locations **Location 1:** **City:** Birmingham **Contacts:** ***Contact 1:*** - **Name:** Haley Sanford - **Role:** CONTACT **Country:** United States **Facility:** Zydus US007 **State:** Alabama **Zip:** 35294 **Location 2:** **City:** Los Angeles **Contacts:** ***Contact 1:*** - **Name:** Nirosha Tilakaratna - **Role:** CONTACT **Country:** United States **Facility:** Zydus US013 **State:** California **Zip:** 90048 **Location 3:** **City:** Pasadena **Contacts:** ***Contact 1:*** - **Name:** Ariadne Cabrera - **Role:** CONTACT **Country:** United States **Facility:** Zydus US011 **State:** California **Zip:** 91105 **Location 4:** **City:** Sacramento **Contacts:** ***Contact 1:*** - **Name:** Jerica Golez - **Role:** CONTACT **Country:** United States **Facility:** Zydus US043 **State:** California **Zip:** 95817 **Location 5:** **City:** Aurora **Contacts:** ***Contact 1:*** - **Name:** Allison Kuehn - **Role:** CONTACT **Country:** United States **Facility:** Zydus US022 **State:** Colorado **Zip:** 80045 **Location 6:** **City:** New Haven **Contacts:** ***Contact 1:*** - **Name:** Suzie Christopher - **Role:** CONTACT **Country:** United States **Facility:** Zydus US037 **State:** Connecticut **Zip:** 06520 **Location 7:** **City:** Jacksonville **Contacts:** ***Contact 1:*** - **Name:** Reagan Dukes - **Role:** CONTACT **Country:** United States **Facility:** Zydus US027 **State:** Florida **Zip:** 32082 **Location 8:** **City:** Lakewood Ranch **Contacts:** ***Contact 1:*** - **Name:** Mandy Burdine - **Role:** CONTACT **Country:** United States **Facility:** Zydus US006 **State:** Florida **Zip:** 34211 **Location 9:** **City:** Miami **Contacts:** ***Contact 1:*** - **Name:** Kenia Moreno - **Role:** CONTACT **Country:** United States **Facility:** Zydus US005 **State:** Florida **Zip:** 33136 **Location 10:** **City:** Marietta **Contacts:** ***Contact 1:*** - **Name:** Lynn Bauch - **Role:** CONTACT **Country:** United States **Facility:** Zydus US020 **State:** Georgia **Zip:** 30060 **Location 11:** **City:** Indianapolis **Contacts:** ***Contact 1:*** - **Name:** Mandy Cruz - **Role:** CONTACT **Country:** United States **Facility:** Zydus US001 **State:** Indiana **Zip:** 46202 **Location 12:** **City:** Rochester **Contacts:** ***Contact 1:*** - **Name:** Mitch Clayton - **Role:** CONTACT **Country:** United States **Facility:** Zydus US023 **State:** Minnesota **Zip:** 55905 **Location 13:** **City:** Saint Louis **Contacts:** ***Contact 1:*** - **Name:** Andrea Riemenschneider - **Role:** CONTACT **Country:** United States **Facility:** Zydus US030 **State:** Missouri **Zip:** 63104 **Location 14:** **City:** Omaha **Contacts:** ***Contact 1:*** - **Name:** Carol Carney - **Role:** CONTACT **Country:** United States **Facility:** Zydus US024 **State:** Nebraska **Zip:** 68198 **Location 15:** **City:** Rochester **Contacts:** ***Contact 1:*** - **Name:** Chelsea DiBella - **Role:** CONTACT **Country:** United States **Facility:** Zydus US035 **State:** New York **Zip:** 14642 **Location 16:** **City:** Charlotte **Contacts:** ***Contact 1:*** - **Name:** Marina Sycheva - **Role:** CONTACT **Country:** United States **Facility:** Zydus US002 **State:** North Carolina **Zip:** 28204 **Location 17:** **City:** Cincinnati **Contacts:** ***Contact 1:*** - **Name:** Lori Ankney - **Role:** CONTACT **Country:** United States **Facility:** Zydus US014 **State:** Ohio **Zip:** 55905 **Location 18:** **City:** Philadelphia **Contacts:** ***Contact 1:*** - **Name:** Stacey Carmody - **Role:** CONTACT **Country:** United States **Facility:** Zydus US015 **State:** Pennsylvania **Zip:** 19141 **Location 19:** **City:** Houston **Contacts:** ***Contact 1:*** - **Name:** Sali Albarouk - **Role:** CONTACT **Country:** United States **Facility:** Zydus US004 **State:** Texas **Zip:** 77030 **Location 20:** **City:** Houston **Contacts:** ***Contact 1:*** - **Name:** DeShara Emerson - **Role:** CONTACT **Country:** United States **Facility:** Zydus US042 **State:** Texas **Zip:** 77030 **Location 21:** **City:** Murray **Contacts:** ***Contact 1:*** - **Name:** Anika Unsworth - **Role:** CONTACT **Country:** United States **Facility:** Zydus US031 **State:** Utah **Zip:** 84107 **Location 22:** **City:** Charlottesville **Contacts:** ***Contact 1:*** - **Name:** Holly McComb - **Role:** CONTACT **Country:** United States **Facility:** Zydus US016 **State:** Virginia **Zip:** 22908 **Location 23:** **City:** Richmond **Contacts:** ***Contact 1:*** - **Name:** Caitlin Hurst - **Role:** CONTACT **Country:** United States **Facility:** Zydus US039 **State:** Virginia **Zip:** 23219 **Location 24:** **City:** Seattle **Contacts:** ***Contact 1:*** - **Name:** Teresa Collins - **Role:** CONTACT **Country:** United States **Facility:** Zydus US033 **State:** Washington **Zip:** 98105 **Location 25:** **City:** Ciudad Autónoma de Buenos Aires **Contacts:** ***Contact 1:*** - **Name:** Ignacio Lucero - **Role:** CONTACT **Country:** Argentina **Facility:** Zydus AR007 **State:** Buenos Aires **Zip:** 1199 **Location 26:** **City:** Ciudad Autónoma de Buenos Aires **Contacts:** ***Contact 1:*** - **Name:** Karina Barroso - **Role:** CONTACT **Country:** Argentina **Facility:** Zydus AR006 **State:** Buenos Aires **Zip:** 1405 **Location 27:** **City:** Ciudad Autónoma de Buenos Aires **Contacts:** ***Contact 1:*** - **Name:** Ailén Sparnocchia - **Role:** CONTACT **Country:** Argentina **Facility:** Zydus AR001 **State:** Buenos Aires **Zip:** 1640 **Location 28:** **City:** Ciudad Autónoma de Buenos Aires **Contacts:** ***Contact 1:*** - **Name:** Verónica Martinez - **Role:** CONTACT **Country:** Argentina **Facility:** Zydus AR005 **State:** Buenos Aires **Zip:** 2345 **Location 29:** **City:** Ciudad Autónoma de Buenos Aires **Contacts:** ***Contact 1:*** - **Name:** Belen Umina - **Role:** CONTACT **Country:** Argentina **Facility:** Zydus AR003 **State:** Buenos Aires **Zip:** 4693 **Location 30:** **City:** Mar del Plata **Contacts:** ***Contact 1:*** - **Name:** Ariana Balcarce - **Role:** CONTACT **Country:** Argentina **Facility:** Zydus AR009 **State:** Buenos Aires **Zip:** 7600 **Location 31:** **City:** Pilar **Contacts:** ***Contact 1:*** - **Name:** Gabriela Marinsalta - **Role:** CONTACT **Country:** Argentina **Facility:** Zydus AR004 **State:** Buenos Aires **Zip:** 1500 **Location 32:** **City:** Rosario **Contacts:** ***Contact 1:*** - **Name:** Gabriela Juaristi - **Role:** CONTACT **Country:** Argentina **Facility:** Zydus AR010 **State:** Santa Fe **Zip:** 2000 **Location 33:** **City:** Adana **Contacts:** ***Contact 1:*** - **Name:** Asya Cıblakbas - **Role:** CONTACT **Country:** Turkey **Facility:** Zydus TR014 **Zip:** 236 **Location 34:** **City:** Altındag **Contacts:** ***Contact 1:*** - **Name:** Müge Demirsu - **Role:** CONTACT **Country:** Turkey **Facility:** Zydus TR016 **Location 35:** **City:** Ankara **Contacts:** ***Contact 1:*** - **Name:** Pınar Anul - **Role:** CONTACT **Country:** Turkey **Facility:** Zydus TR004 **Zip:** 1604 **Location 36:** **City:** Bursa **Contacts:** ***Contact 1:*** - **Name:** Merve Karatas - **Role:** CONTACT **Country:** Turkey **Facility:** Zydus TR005 **Zip:** 16059 **Location 37:** **City:** Cebeci **Contacts:** ***Contact 1:*** - **Name:** Melike Zeynep Ciftci - **Role:** CONTACT **Country:** Turkey **Facility:** Zydus TR017 **Location 38:** **City:** Gaziantep **Contacts:** ***Contact 1:*** - **Name:** Selin Büdeyri Sayın - **Role:** CONTACT **Country:** Turkey **Facility:** Zydus TR008 **Zip:** 27080 **Location 39:** **City:** Istanbul **Contacts:** ***Contact 1:*** - **Name:** Aybüke Mutaflar Peksert - **Role:** CONTACT **Country:** Turkey **Facility:** Zydus TR009 **Zip:** 34093 **Location 40:** **City:** Istanbul **Contacts:** ***Contact 1:*** - **Name:** Sevval Ceren Asi - **Role:** CONTACT **Country:** Turkey **Facility:** Zydus TR001 **Zip:** 34899 **Location 41:** **City:** Istanbul **Contacts:** ***Contact 1:*** - **Name:** Kubra Karacaoglu - **Role:** CONTACT **Country:** Turkey **Facility:** Zydus TR003 **Zip:** 36764 **Location 42:** **City:** Istanbul **Contacts:** ***Contact 1:*** - **Name:** Aybüke Mutaflar Peksert - **Role:** CONTACT **Country:** Turkey **Facility:** Zydus TR010 **Location 43:** **City:** Izmir **Contacts:** ***Contact 1:*** - **Name:** Gizem Gunyer - **Role:** CONTACT **Country:** Turkey **Facility:** Zydus TR002 **Zip:** 06230 **Location 44:** **City:** Izmir **Contacts:** ***Contact 1:*** - **Name:** Buket Uzun - **Role:** CONTACT **Country:** Turkey **Facility:** Zydus TR013 **Location 45:** **City:** Kocaeli **Contacts:** ***Contact 1:*** - **Name:** Dunya Avcilar - **Role:** CONTACT **Country:** Turkey **Facility:** Zydus TR011 **Zip:** 41110 **Location 46:** **City:** Melikgazi **Contacts:** ***Contact 1:*** - **Name:** Banu Çiçek Yakışan - **Role:** CONTACT **Country:** Turkey **Facility:** Zydus TR015 **Location 47:** **City:** Mersin **Contacts:** ***Contact 1:*** - **Name:** Didem Balci - **Role:** CONTACT **Country:** Turkey **Facility:** Zydus TR006 **Zip:** 33079 #### Overall Officials **Official 1:** **Affiliation:** Zydus Therapeutics Inc. **Name:** Deven Parmar **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001649 - Term: Bile Duct Diseases - ID: D000001660 - Term: Biliary Tract Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000002780 - Term: Cholestasis, Intrahepatic - ID: D000002779 - Term: Cholestasis - ID: D000008107 - Term: Liver Diseases - ID: D000008103 - Term: Liver Cirrhosis - ID: D000005355 - Term: Fibrosis - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M6002 - Name: Cholangitis - Relevance: HIGH - As Found: Cholangitis - ID: M11105 - Name: Liver Cirrhosis, Biliary - Relevance: HIGH - As Found: Primary Biliary Cholangitis - ID: M11103 - Name: Liver Cirrhosis - Relevance: LOW - As Found: Unknown - ID: M4935 - Name: Bile Duct Diseases - Relevance: LOW - As Found: Unknown - ID: M4946 - Name: Biliary Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M6019 - Name: Cholestasis - Relevance: LOW - As Found: Unknown - ID: M6020 - Name: Cholestasis, Intrahepatic - Relevance: LOW - As Found: Unknown - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown - ID: M8485 - Name: Fibrosis - Relevance: LOW - As Found: Unknown - ID: T4683 - Name: Primary Biliary Cholangitis - Relevance: HIGH - As Found: Primary Biliary Cholangitis ### Condition Browse Module - Meshes - ID: D000002761 - Term: Cholangitis - ID: D000008105 - Term: Liver Cirrhosis, Biliary ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427382 **Brief Title:** Prediction of Hypotension Using Perfusion Index Following Spinal Anesthesia **Official Title:** Prediction of Hypotension Using Perfusion Index Following Spinal Anesthesia #### Organization Study ID Info **ID:** perfusion index #### Organization **Class:** OTHER **Full Name:** Ankara City Hospital Bilkent ### Status Module #### Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-08-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-25 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ankara City Hospital Bilkent #### Responsible Party **Investigator Affiliation:** Ankara Yildirim Beyazıt University **Investigator Full Name:** Fatma Kavak Akelma **Investigator Title:** anesthesiology and reanimation associate professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** It is aimed to investigate whether perfusion index (PI) can predict hypotension after spinal anesthesia in elderly patients as much as in young patients. **Detailed Description:** In orthopedic lower extremity surgeries, spinal anesthesia is a preferred method of anesthesia compared to general anesthesia. Spinal anesthesia may cause severe hypotension and adverse effects in the patient due to pharmacologic sympathectomy. Especially elderly patients and patients with comorbid diseases are at risk. Hypoperfusion and vasopressor drugs to be used in treatment may lead to adverse effects. Perfusion index is calculated as the ratio non-pulsatile to pulsatile flow in peripheral capillary blood flow. Perfusion index is a non-invasive method that provides insight into the dynamics of vascular tone using pulse oximetry. It can be used to evaluate perfusion dynamics due to changes in peripheral vascular tone and to detect the possibility of developing hypotension following spinal anesthesia. There is insufficient data to evaluate whether PI is a marker of hypotension after spinal anesthesia in older patients compared to younger patients. The planned study aims to investigate whether PI predicts hypotension after spinal anesthesia in older patients as well as young patients. Preoperative demographic data of the patients, preoperative heart rate, noninvasive systolic, and diastolic blood pressures, mean arterial pressures, and peripheral oxygen saturations will be measured and noted. For the initial perfusion index (PI) value, PI measurements will be taken 3 times at a few minute intervals with a noninvasive probe attached to the finger, and the average will be recorded as the initial PI value. Spinal anesthesia will be applied by injecting an appropriate dose of 0.5% hyperbaric bupivacaine intrathecally, depending on the patient's structure and the type of surgery, to ensure adequate sensory and motor blockade. The patient will be immediately placed in the supine position. After the appropriate period, the level of sensory blockade will be evaluated. Heart rate, noninvasive systolic, and diastolic blood pressures, mean arterial pressure, peripheral oxygen saturation, and perfusion index will be recorded. Hypotension after spinal anesthesia will be defined as systolic blood pressure less than 90 mmHg, systolic blood pressure decrease by more than 25% from the preoperative baseline value, or average blood pressure less than 60 mmHg. Patients under the age of 60 or over the age of 60 who will undergo lower extremity surgery under spinal anesthesia will be evaluated in two groups. It will be examined whether there are differences between the groups in terms of demographic data (age, gender, comorbidity, etc.) and perfusion index. The study's primary outcome is to investigate whether PI values have a predictive value in predicting post-spinal hypotension between the two groups and, if so, whether there is a statistically significant difference. The secondary outcome is to evaluate whether the perfusion index can be used to predict spine-induced hypotension in orthopedic lower extremity surgery. ### Conditions Module **Conditions:** - Anesthesia, Spinal **Keywords:** - spinal anesthesia - perfusion index - orthopedic surgery ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients aged 65 years and older **Intervention Names:** - Device: Perfusion index **Label:** group 1 (age > 65 years) #### Arm Group 2 **Description:** Patients aged 18 to 65 years **Intervention Names:** - Device: Perfusion index **Label:** group 2 (age < 65 years) ### Interventions #### Intervention 1 **Arm Group Labels:** - group 1 (age > 65 years) - group 2 (age < 65 years) **Description:** Perfusion index determination using non-invasive pulse oximetry **Name:** Perfusion index **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Determine a threshold for baseline PI value using logistic regression analysis to predict hypotension after spinal anesthesia **Measure:** Perfusion index age difference **Time Frame:** 1 hours #### Secondary Outcomes **Description:** Determining baseline perfusion index threshold to predict possible hypotension after spinal anesthesia **Measure:** Perfusion index cut-off point **Time Frame:** 1 hours **Description:** recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the end of the procedure **Measure:** Systolic blood pressure **Time Frame:** 1 hours **Description:** recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the end of the procedure **Measure:** Diastolic blood pressure **Time Frame:** 1 hours **Description:** recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the end of the procedure **Measure:** Mean arterial pressure **Time Frame:** 1 hours **Description:** recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the end of the procedure **Measure:** Hearth Rate **Time Frame:** 1 hours **Description:** recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the end of the procedure **Measure:** perfusion index **Time Frame:** 1 hours **Description:** recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the end of the procedure **Measure:** oxygen saturation(SpO2) **Time Frame:** 1 hours **Description:** time to reach the bromage 3 score **Measure:** bromage score **Time Frame:** 1 hours **Description:** time to reach t10 dermatome level **Measure:** T10 dermatome **Time Frame:** 1 hours **Description:** the highest dermatome level achieved with spinal anesthesia **Measure:** dermatomal level **Time Frame:** 1 hours **Description:** ephedrine use **Measure:** use ephedrine **Time Frame:** 24 hours **Description:** To study side effects between 2 groups **Measure:** side effects **Time Frame:** 24 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * American Society of Anesthesiologists (ASA) I-II-III physical status * patients planned for effective lower extremity surgery in the supine position * age \>18 years Exclusion Criteria: * Known cardiac abnormalities (left ventricular ejection fraction \<50% or decompensated heart failure, heart block, arrhythmia) * uncontrolled hypertension * hyperthyroidism * monoamine oxidase inhibitor use * chronic beta-blocker or digoxin therapy * severe arrhythmia * peripheral arterial disease * history of glaucoma * hepatic cell failure * renal failure * local anesthetic allergy * contraindications for spinal anesthesia **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** patients admitted to ankara city hospital for lower extremity surgery in supine position ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Fatma K Akelma **Phone:** 05327079113 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10072 - Name: Hypotension - Relevance: HIGH - As Found: Hypotension - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007022 - Term: Hypotension ### 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: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427369 **Brief Title:** An Investigational Scan (124I-hJAA-F11 PET/CT) for Diagnosing Lung Cancer **Official Title:** Noninvasive Diagnosis of Lung Cancer With Radiolabeled hJAA-F11 #### Organization Study ID Info **ID:** I -1774023 #### Organization **Class:** OTHER **Full Name:** Roswell Park Cancer Institute ### Status Module #### Completion Date **Date:** 2027-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Roswell Park Cancer Institute #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** This phase I trial studies the side effects of 124I-hJAA-F11, and evaluates how well it works in diagnosing lung cancer. 124I-hJAA-F11 uses a known radioactive substance used in imaging called iodine 124 (124I). hJAA-F11 is an experimental (investigational) antibody that is currently being evaluated as a potential treatment for lung cancer. In animal studies, hJAA-F11 has shown anti-tumor activity against tumors bearing the Thomsen-Friedenreich antigen that is found in over 90% of lung cancers. 124I-hJAA-F11 has the 124I radioactive dye attached to this investigational antibody, which may be a potential tool for imaging-based diagnosis of lung cancer. **Detailed Description:** PRIMARY OBJECTIVE: I. To evaluate the safety and diagnostic efficacy of 124I-hJAA-F11 in detecting lung cancer. SECONDARY OBJECTIVES: I. To assess the development of anti-drug antibodies following administration of 124I-hJAAF11. II. To characterize concordance in lesions characterized by 124I-hJAA-F11-based positron emission tomography/computed tomography (PET/CT) compared to standard of care FDG (fluorodeoxyglucose)-PET. III. To perform exploratory biomarker analyses based on conventional tissue and liquid-based platforms. OUTLINE: Patients receive 124I-hJAA-F11 intravenously (IV) on day 0. Patients then undergo PET/CT on day 1 (20-28 hours post 124I-hJAA-F11), day 2 (48-96 hours post 124I-hJAA-F11), day 5-6 (120-144 hours post 124I-hJAA-F11), and day 7-8 (168-192 hours post 124I-hJAA-F11). Patients also undergo FDG PET/CT during screening and undergo blood sample collection throughout the trial. After completion of the study intervention, patients are followed up at day 8-14, weeks 4 and 8, and at 6 and 12 months. ### Conditions Module **Conditions:** - Extensive-stage Small-cell Lung Cancer - Limited-stage Small-cell Lung Cancer - Lung Non-Small Cell Carcinoma - Stage IIIA Lung Cancer - Stage IV Lung Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 15 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients receive 124I-hJAA-F11 IV on day 0. Patients then undergo PET/CT on day 1 (20-28 hours post 124I-hJAA-F11), day 2 (48-96 hours post 124I-hJAA-F11), day 5-6 (120-144 hours post 124I-hJAA-F11), and day 7-8 (168-192 hours post 124I-hJAA-F11). Patients also undergo FDG PET/CT during screening and undergo blood sample collection throughout the trial. **Intervention Names:** - Other: Radioconjugate - Procedure: Positron Emission Tomography - Procedure: Computed Tomography - Procedure: FDG-Positron Emission Tomography and Computed Tomography Scan - Procedure: Biospecimen Collection **Label:** Diagnostic **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Diagnostic **Description:** 1241-hJAA-F11 IV administration **Name:** Radioconjugate **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Diagnostic **Description:** PET/CT Imaging **Name:** Positron Emission Tomography **Other Names:** - PET - PET SCAN **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Diagnostic **Description:** PET/CT Imaging **Name:** Computed Tomography **Other Names:** - CAT - CAT Scan **Type:** PROCEDURE #### Intervention 4 **Arm Group Labels:** - Diagnostic **Description:** FDG PET/CT Imaging **Name:** FDG-Positron Emission Tomography and Computed Tomography Scan **Other Names:** - FDG PET/CT **Type:** PROCEDURE #### Intervention 5 **Arm Group Labels:** - Diagnostic **Description:** Blood sample collection imaging **Name:** Biospecimen Collection **Other Names:** - Biological Sample Collection **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Incidence of severe adverse events will be graded according to CTCAE ver 5 **Measure:** Incidence of grade 3+ I-hJAA-F11 related adverse events **Time Frame:** Up to 6 months after final PET/CT **Description:** uptake values for tumor and normal organs will be measured and tumor to normal orgrans background ratios will be obtained. **Measure:** Evaluate Diagnostic efficacy of I-hJAA-F11 **Time Frame:** Within 30 days of final I/hJAA-f11 PET/CT #### Secondary Outcomes **Measure:** Development of anti-drug antibodies **Time Frame:** Up to approximately 8 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with histologically or cytologically diagnosed small cell lung cancer (SCLC; either extensive stage or limited stage) or non-small cell lung cancer (NSCLC; at least clinical stage IIIA according to the American Joint Cancer Committee \[AJCC\] 8th edition) * Patients undergoing FDG-PET scan as standard of care testing. * Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2 * Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately Exclusion Criteria: * Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection (exceptions allowed include patients on chronic antiviral or anti-bacterial medications without acute flares in the preceding 2 weeks), symptomatic congestive heart failure, unstable angina pectoris, Child-Pugh class C, dialysis-dependence, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or nursing female participants **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** ASK RPCI **Phone:** 1-877-275-7724 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Roswell Park Comprehensive Cancer Center **Name:** Grace Dy, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - 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 - 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 - 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: HIGH - As Found: Lung Cancer - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: HIGH - As Found: Lung Non-Small Cell Carcinoma - ID: M28323 - Name: Small Cell Lung Carcinoma - Relevance: HIGH - As Found: Small Cell Lung Cancer - 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 - ID: T5271 - Name: Small Cell Lung Cancer - Relevance: HIGH - As Found: Small Cell Lung Cancer ### Condition Browse Module - Meshes - ID: D000008175 - Term: Lung Neoplasms - ID: D000055752 - Term: Small Cell Lung Carcinoma - ID: D000002289 - Term: Carcinoma, Non-Small-Cell Lung ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427356 **Brief Title:** PREVAIL Interdisciplinary Track: A Pragmatic Randomized Clinical Trial **Official Title:** PREVAIL: Efficacy of a Veterans Healthcare Administration (VHA) Whole Health Interdisciplinary Pain Clinic #### Organization Study ID Info **ID:** REC 0004 #### Organization **Class:** FED **Full Name:** Salem Veterans Affairs Medical Center ### Status Module #### Completion Date **Date:** 2025-07-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** FED **Name:** Durham VA Health Care System **Class:** UNKNOWN **Name:** VISN 6 MIRECC **Class:** UNKNOWN **Name:** Bedford VA Health Care System **Class:** OTHER **Name:** Stanford University #### Lead Sponsor **Class:** FED **Name:** Salem Veterans Affairs Medical 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:** The goal of this clinical trial is to \[primary purpose learn if a team that involves five types of pain specialists (interventional pain, psychology, pharmacy, nutrition, physical therapy) can treat chronic pain in Veterans. The main questions it aims to answer are: * Do patients report less pain after six months in the program? * Do patients report that pain gets in the way of their life less after six months in the program? The researchers will compare participants who participate in the program to those that wait for six months before participating in the program. Participants will * Meet with the team of pain specialists to develop a plan to treat their pain * Receive calls from a coach once per month * Return to meet with the team of pain specialists for a six-month follow-up appointment * Fill out surveys ### Conditions Module **Conditions:** - Chronic Pain **Keywords:** - Whole health - rural health - Interdisciplinary team ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants complete surveys, meet with five pain specialists to develop individualized treatment plans based on whole health, receive monthly coaching calls for five months, then meet with the pain specialists once more for a 6-month follow-up appointment and complete surveys. **Intervention Names:** - Behavioral: PREVAIL Interdisciplinary Team **Label:** Interdisciplinary Team **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants complete surveys but do not engage with the pain specialists for 6 months. **Label:** Waitlist Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Interdisciplinary Team **Description:** Patient meets simultaneously with an interdisciplinary team (IDT) five pain specialists and develops an individualized treatment plan based on Whole Health. Participants receive five months of coaching calls then return six months later for a follow-up visit with the IDT. **Name:** PREVAIL Interdisciplinary Team **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** A 9-item scale used to quantify an individual's pain experience (0-10) with higher scores suggesting worse pain severity and pain interference. **Measure:** Brief Pain Inventory (BPI) **Time Frame:** Baseline, 6-months #### Secondary Outcomes **Description:** A 36-item scale to assess quality of life, including any impact of health problems on completing activities, as well as energy and emotions, with lower scores indicating a higher impact of health problems. **Measure:** Short Form-36 Item (SF-36) **Time Frame:** Baseline, 6-months **Description:** A 7-item scale that assesses sleep disturbances, with higher scores reflecting more sleep difficulty. **Measure:** Insomnia Severity Index **Time Frame:** Baseline, 6-months **Description:** A 10-item scale used to determine how confident an individual is in accomplishing tasks despite the pain (0=not at all confident and 6= completely confident) with higher scores denoting higher levels of pain self-efficacy. **Measure:** Pain Self-Efficacy Questionnaire **Time Frame:** Baseline, 6-months **Description:** A 24-item scale used to assess one's perception of their pain experience (1= never, 5= always), with higher scores indicating higher levels of pain catastrophizing. **Measure:** University of Washington- Concerns about Pain Scale 24-item **Time Frame:** Baseline, 6-months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Veteran receiving care at the Salem VA Health Care System (Salem VAHCS) per electronic medical record (EMR) * Patient participating in PREVAIL Interdisciplinary Team Track per EMR * Chronic Pain Diagnosis: Defined as pain lasting more than three months per EMR Exclusion Criteria: * Diagnosis of Mild Neurocognitive Disorder or Major Neurocognitive Disorder based on Diagnostic Statistical Manual of Mental Disorders, 5th edition, Text Revision (DSM-5-TR) per EMR * Veteran has a current acute physical injury that would artificially elevate pain scores during study period per EMR * Veteran intends to have a pain-related surgery during the study period per EMR **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Rena E Courtney, PhD **Phone:** 540-982-2463 **Phone Ext:** 4478 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Kris Ann Oursler, MD **Phone:** 540-982-2463 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Salem VA Health Care System **Name:** Rena E Courtney, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Courtney RE, Schadegg MJ. Chronic, Noncancer Pain Care in the Veterans Administration: Current Trends and Future Directions. Anesthesiol Clin. 2023 Jun;41(2):519-529. doi: 10.1016/j.anclin.2023.02.004. Epub 2023 Mar 15. **PMID:** 37245954 **Citation:** Darnall BD, Edwards KA, Courtney RE, Ziadni MS, Simons LE, Harrison LE. Innovative treatment formats, technologies, and clinician trainings that improve access to behavioral pain treatment for youth and adults. Front Pain Res (Lausanne). 2023 Jul 20;4:1223172. doi: 10.3389/fpain.2023.1223172. eCollection 2023. **PMID:** 37547824 **Citation:** Courtney RE, Schadegg MJ, Bolton R, Smith S, Harden SM. Using a Whole Health Approach to Build Biopsychosocial-Spiritual Personal Health Plans for Veterans with Chronic Pain. Pain Manag Nurs. 2024 Feb;25(1):69-74. doi: 10.1016/j.pmn.2023.09.010. Epub 2023 Oct 13. **PMID:** 37839983 ## 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: 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 ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427343 **Acronym:** IRONDOSE **Brief Title:** The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency **Official Title:** The Effects of Low-dose Versus High-dose Intravenous Iron Therapy With Ferric Derisomaltose in Patients With Chronic Heart Failure and Iron Deficiency: a Randomized, Open-label, Blind Endpoint Trial (IRONDOSE) #### Organization Study ID Info **ID:** 2023-ZF-62 #### Organization **Class:** OTHER **Full Name:** China-Japan Friendship Hospital ### Status Module #### Completion Date **Date:** 2026-12-21 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-03 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2023-10-01 **Type:** ACTUAL **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** China-Japan Friendship Hospital #### Responsible Party **Investigator Affiliation:** China-Japan Friendship Hospital **Investigator Full Name:** Jingyi Ren **Investigator Title:** Professor of medicine(Cardiology), Deputy Director of the Cardiology Department and Director of the Heart Failure Center **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study will address whether intravenous (IV) iron repletion with a more intensive target will provide greater benefits in improving exercise capacity for patients with chronic heart failure and iron deficiency. One group of participants will receive a high-dose IV iron regimen with a more intensive target, and the other group will receive a low-dose IV iron regimen with a less intensive target. **Detailed Description:** Iron deficiency is a common and important comorbidity in heart failure. Randomized controlled trials have consistently demonstrated a beneficial effect of IV iron on exercise capacity and quality of life in iron-deficient patients with HF and reduced ejection fraction. However, these randomized controlled trials exhibit striking heterogeneity in targeting levels for maintenance strategies of IV iron repletion. Some studies (FERRIC-HF, FAIR-HF) withheld intravenous iron in cases of ferritin \>800 ng/mL, hemoglobin \>16.0 g/dL, or transferrin saturation (TSAT) \>50%, while other studies (HEART-FID, IRONMAN) focused on targeting levels that are simply above the definition of iron deficiency. Additionally, the PIVOTAL trial showed that high-dose IV iron decreased recurrent heart failure events in patients undergoing hemodialysis compared to a lower-dose regimen. Whether functional outcomes differ between those on lower versus higher iron repletion targets among patients with heart failure remains unknown. This study will help us address this question. This is an investigator-initiated, prospective, randomized, open-label blind endpoint study to assess the effects of high-dose IV iron repletion compared to a low-dose IV iron repletion on 12-month change in peak oxygen uptake (VO2) for patients with chronic heart failure and concomitant iron deficiency. Patients with chronic heart failure and iron deficiency will be enrolled and randomized in a 1:1 ratio to receive a high-dose IV iron regimen and a low-dose IV iron regimen. After the initial iron repletion, ferritin concentration and TSAT were measured every three months and the results used to determine the dose of ferric derisomaltose during the follow-up period. In the high dose group, iron dosing will repeat as long as the serum ferritin was not \>700ng/mL, or if TSAT was not \>40%. Patients in the low dose group will receive repeat iron dosing if ferritin \<100 ng/mL, or if ferritin 100-300 ng/mL and TSAT \<20%, in line with criteria for iron deficiency in current guidelines. ### Conditions Module **Conditions:** - Heart Failure - Iron Deficiency **Keywords:** - IRONDOSE ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Drug: Ferric Derisomaltose ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 114 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants randomized to this arm will receive repeat iron dosing as long as the serum ferritin was not \>700 ng/mL, or if TSAT was not \>40% during follow-up. Iron to be administered as ferric derisomaltose. Ferric derisomaltose will be administered according to the dosing schedule determined by the patient's body weight and hemoglobin value. Infused over a minimum of 15 mins for doses up to and including 1000mg, and a minimum of 30 mins for doses \>1000mg. **Intervention Names:** - Drug: High-dose ferric derisomaltose **Label:** High dose **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants randomized to this arm will receive repeat iron dosing if ferritin \<100 ng/mL or if ferritin 100-300 ng/mL and TSAT \<20% during follow-up. Iron to be administered as ferric derisomaltose in analogy to high-dose arm. **Intervention Names:** - Drug: Low-dose ferric derisomaltose **Label:** Low dose **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - High dose **Description:** After baseline assessment, participants will be randomized in a 1:1 ratio to receive a high-dose IV iron regimen and a low-dose IV iron regimen. After the initial iron repletion, ferritin concentration and TSAT were measured every three months and the results used to determine the dose of ferric derisomaltose during follow-up. In the high-dose group, participants will receive repeat iron dosing as long as the serum ferritin was not \>700 ng/mL, or if TSAT was not \>40% during follow-up. **Name:** High-dose ferric derisomaltose **Other Names:** - More intensive target **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Low dose **Description:** In the low-dose group, participants will receive repeat iron dosing if ferritin \<100 ng/mL or if ferritin 100-300 ng/mL and TSAT \>20% during follow-up. **Name:** Low-dose ferric derisomaltose **Other Names:** - Less intensive target **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Peak VO2 measured by a maximal effort Cardiopulmonary Exercise Test (CPET) **Measure:** Change in peak VO2 (ml/min/kg） **Time Frame:** Baseline to Week 52 #### Secondary Outcomes **Description:** Measured by CPET **Measure:** Change in VO2 at ventilatory threshold (ml/min） **Time Frame:** Baseline to Week 52 **Description:** Measured by CPET **Measure:** Change in heart rate at peak exercise (bpm) **Time Frame:** Baseline to Week 52 **Description:** Measured by CPET **Measure:** Change in peak respiratory exchange ratio **Time Frame:** Baseline to Week 52 **Measure:** Change in 6-minute walking distance (m) **Time Frame:** Baseline to Week 26 and Week 52 **Description:** Measured by cardiac magnetic resonance imaging **Measure:** Change in myocardial iron content by cardiac magnetic resonance imaging T2 star **Time Frame:** Baseline to Week 52 **Description:** Measured by skeletal muscle magnetic resonance imaging **Measure:** Change in skeletal muscle iron content by magnetic resonance imaging T2 star **Time Frame:** Baseline to Week 52 **Description:** The KCCQ is a validated instrument for self-assessment of quality of life and health status in heart failure patients. The clinical summary score, which is derived from the physical limitations and heart failure symptoms domains of the KCCQ is a valid measure for assessing the patient's health aspects that may be influenced by CV medications. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. **Measure:** Change in the clinical summary score by Kansas City Cardiomyopathy Questionnaire (KCCQ) **Time Frame:** Baseline to Week 52 **Description:** EQ-5D-5L: European Quality of Life-5 Dimensions-5 Levels The EQ 5D questionnaire consists of a health descriptive system for participants to self-classify and rate their health status on the day of administration. The descriptive system includes 5 items/dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, which are coded from 1 (best state) to 5 (worst state). **Measure:** Change in the EQ-5D-5L questionnaire indexed value **Time Frame:** Baseline to Week 52 **Description:** The MMSE is a cognitive test. The score is ranged from 0-30 (units of a scale). 30 points is the better outcome. The investigators will assess the change in the score. **Measure:** Change in cognitive function score by Mini-Mental State Examination (MMSE) **Time Frame:** Baseline to Week 52 **Description:** Tested in blood samples **Measure:** Change in concentration of N-terminal pro-brain natriuretic peptide (NT-proBNP, pg/mL) **Time Frame:** Baseline to Week 52 **Description:** Assessed by echocardiography **Measure:** Change in left ventricular ejection fraction (LVEF, %) **Time Frame:** Baseline to Week 52 **Description:** Assessed by echocardiography **Measure:** Change in left ventricular global longitudinal stress (LVGLS, %) **Time Frame:** Baseline to Week 52 **Description:** Effects on mortality and HF-related hospitalization rates in patients with heart failure. **Measure:** Mortality and heart failure-related hospitalization rates **Time Frame:** Up to 52 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age \>18 years. 2. Left ventricular ejection fraction (LVEF) \<50% within 2 years prior to planned randomization (assessed by echocardiography or MRI). 3. New York Heart Association (NYHA) class II \~ III. 4. Either hospitalization for HF within 6 months prior to planned randomization or elevated plasma levels of natriuretic peptides within 3 months of randomization. a. For patients in sinus rhythm: NT- proBNP \>300 pg/mL or BNP \>100 pg/mL. b. For patients in atrial fibrillation: NT-proBNP \>600 pg/mL or BNP \>200 pg/mL. 5. Subjects with stable CHF (NYHA II/III functional class) on optimal background therapy (as determined by the investigator) for at least 4 weeks with no dose changes of heart failure drugs during the last 2 weeks (with the exception of diuretics). 6. Serum ferritin \<100 ng/mL or serum ferritin 100-300 ng/mL and TSAT \<20%. 7. Able and willing to perform a CPET at the time of randomization. 8. Able and willing to provide informed consent. Exclusion Criteria: 1. Hemoglobin \<9.0 g/dL or Hemoglobin \>15.0 g/dL. 2. Renal dialysis or MDRD/CKD-EPI estimated glomerular filtration rate (eGFR) \<15 ml/min/1.73m2. 3. Body weight \<35 kg. 4. Heart failure was secondary to valvular diseases or congenital heart diseases. 5. History of acquired iron overload; known hemochromatosis or first relatives with hemochromatosis. 6. Known hypersensitivity to ferric derisomaltose or other IV iron product. 7. Known active infection (defined as currently treated with oral or intravenous antibiotics), bleeding (gastrointestinal hemorrhagia, menorrhagia, history of peptic ulcer with no evidence of healing or inflammatory bowel disease), malignancy, and hemolytic anemia. 8. History of chronic liver disease and/or alanine transaminase (ALT) or aspartate transaminase (AST) \>3 times the upper limit of the normal range; myelodysplastic disorder; and known HIV/AIDS disease. 9. Acute myocardial infarction, acute coronary syndrome, transient ischemic attack, or stroke within 3 months prior to randomization. 10. Revascularization therapy (coronary artery bypass grafting, percutaneous intervention, or major surgery) within 3 months prior to randomization; or planning cardiac surgery or revascularization. 11. Already receiving erythropoietin, IV or oral iron therapy, and blood transfusion in previous 30 days prior to randomization. 12. Use of concurrent immunosuppressive therapy 13. Any of the following diseases that hinders exercise testing: severe musculoskeletal disease, unstable angina, obstructive cardiomyopathy, severe uncorrected valvular disease, or uncontrolled slow or rapid arrhythmia (mean ventricular rate \>100 beats/min at rest), or uncontrolled hypertension with blood pressure \>160/100 mm Hg. 14. Investigator considers a possible alternative diagnosis to account for the patient's HF symptoms: severe obesity, primary pulmonary hypertension, or chronic obstructive pulmonary disease. 15. Pregnancy or breast feeding. 16. Participation in another intervention study involving a drug or device within the past 90 days. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jingyi Ren **Phone:** 18600195099 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Lina Su **Phone:** 18801230212 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Lina Su - **Phone:** 18801230212 - **Role:** CONTACT ***Contact 2:*** - **Name:** Jingyi Ren - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** China-Japan Friendship Hospital **State:** Beijing **Status:** RECRUITING **Zip:** 100044 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000019189 - Term: Iron Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000000747 - Term: Anemia, Hypochromic - ID: D000000740 - Term: Anemia - ID: D000006402 - Term: Hematologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9421 - Name: Heart Failure - Relevance: HIGH - As Found: Heart Failure - 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: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - 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: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006333 - Term: Heart Failure - ID: D000018798 - Term: Anemia, Iron-Deficiency - ID: D000090463 - Term: Iron Deficiencies ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M10533 - Name: Iron - Relevance: LOW - As Found: Unknown - ID: M207501 - Name: Chrysarobin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427330 **Brief Title:** Phase II Study of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of Acute Lymphoblastic Leukemia **Official Title:** Phase II Study Assessing the Efficacy and Safety of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of High Risk Acute Lymphoblastic Leukemia #### Organization Study ID Info **ID:** IIT2024022-EC-1 #### Organization **Class:** OTHER **Full Name:** Institute of Hematology & Blood Diseases Hospital, China ### Status Module #### Completion Date **Date:** 2026-05-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05-20 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Institute of Hematology & Blood Diseases Hospital, China #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** To learn about the safety of post-HSCT two dose Inotuzumab Ozogamicin to participants with high risk B cell acute lymphoblastic leukemia(B-ALL). Also, to learn if giving Inotuzumab Ozogamicin to post-HSCT patients with high-risk B- ALL can help to reduce relapse and prolong disease free survival and overall survival. **Detailed Description:** This is a Phase II study of inotuzumab ozogamicin for the treatment of patients who underwent transplantation for ALL and have a high risk of relapse. Participants will receive study treatment two doses until relapse of disease, unacceptable toxicity, or death, whichever occurs first Primary Objective • To assess the efficacy of inotuzumab ozogamicin as measured by disease free survival (DFS) at one year. Secondary Objective(s) * To evaluate relapse rate, nonrelapse mortality (NRM), relapse, relapse-related mortality and overall survival (OS) at 1 year. * To determine safety profile of inotuzumab ozogamicin after transplant including the incidence of hematological toxicity, secondary graft failure and other adverse event(AE)/severe adverse event(SAEs) ### Conditions Module **Conditions:** - Acute Lymphoid Leukemia ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 21 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Inotuzumab ozogamicin **Label:** Inotuzumab ozogamicin **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Inotuzumab ozogamicin **Description:** 1. st dose is given after D+60：inotuzumab 0.3mg/m2 2. nd dose is given after 1 month：inotuzumab 0.6mg/m2 **Name:** Inotuzumab ozogamicin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Efficacy as measured by DFS at one year, estimated using Kaplan-Meier, reported as median and 2-sided 80% and 95% Confidence Interval (CI) DFS is defined as "Time from date of HSCT to the date of disease progression (ie,objective progression, relapse from CR/CRi), or death due to any cause, whichever occurs first (including post-study treatment follow-up disease assessments)". **Measure:** DFS **Time Frame:** at one year after HSCT #### Secondary Outcomes **Description:** Defined from time from HSCT to death due to any cause Defined from time from date of HSCT to death due to any cause, estimated using Kaplan-Meier, reported as median and 95% CI Difference in time-to-event endpoints will be tested using a 1-sided log-rank test at a significance level of 0.10 **Measure:** Overall survival **Time Frame:** at one year after HSCT **Description:** Defined as time from date of HSCT to the date of first relapse. Reported as Cumulative Incidence **Measure:** Relapse **Time Frame:** at one year after HSCT **Description:** Defined as time from date of first dose to death due to any cause without prior relapse. **Measure:** NRM **Time Frame:** at one year after HSCT **Description:** Number of patients who develop hematological toxicity while on study, defined as grade of anemia, neutropenia and thrombocytopenia, etc. **Measure:** Incidence of hematological toxicity **Time Frame:** at one year after HSCT **Description:** Number of patients who develop secondary graft failure while on study, defined as: Either cytopenias after initial engraftment (ANC \<500/µL), with (a) donor chimerism of less than 5% or (b) falling donor chimerism with intervention such as second transplant or donor lymphocyte infusion (DLI) or (c) patient death due to cytopenias, and fall in donor chimerism, even if chimerism was \>5%. Exclusion criteria for diagnosis of GF were (a) disease relapse (b) graft versus host disease or (c) other causes of cytopenias such as, viral infections, or drug induced **Measure:** Incidence of secondary graft failure(GF) **Time Frame:** at one year after HSCT **Description:** safety profile of intervention as measured by percent of participants with any grade AE/SAEs **Measure:** Percent of participants with AE/SAEs **Time Frame:** at one year after HSCT ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosis of CD22-positive Acute Lymphoblastic Leukemia * Patients who underwent an allogeneic hematopoietic stem cell transplantation(HSCT) from any donor source or auto-HSCT for acute lymphocytic leukemia * Patients who are after T+60 after transplantation * Patients who have/are either: * High risk B-ALL: (1) high white blood cell(WBC) count when newly diagnosed, (2) Poor risk group according to NCCN guideline 2021 of Acute Lymphoblastic * Leukemia * Relapsed or refractory to at least 1 line of treatment * Minimal residual disease(MRD) positive before HSCT, including flow cytometry and cytogenetic test * Patients who have \> 99% donor chimerism after allogeneic transplantation. * Eastern Cooperative Oncology Group(ECOG) Performance status ≤ 2 * Participants must have ANC \> 1,000/µL for 3 days and platelet transfusion independence as defined as a platelet count \> 50,000/µL for 7 days. * ≥ 18 years old, including male and female * Participants must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients with evidence of disease progression prior to enrollment * Persistent prior treatment toxicities Grade 2 and above according to NCI CTCAE Version 4.03 (with the exception for alopecia, neuropathy, etc.) * Patients with inadequate organ function and can't tolerate the study treatment determined by investigator as defined by: * Severe renal deficiency, with creatinine clearance \< 50ml/min * Severe hepatic deficiency * Bilirubin, aspartate aminotransferase(AST), and/or ALT(ALT) \> 2X institutional upper limit of normal * Severe cardiac or pulmonary deficiency * Graft-versus-host disease(GVHD) grade III or IV (for patients with a prior allogeneic transplant). * Active acute or chronic GVHD of the liver (for patients with a prior allogeneic transplant) * History of veno-occlusive disease(VOD) * Second active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) * Patients with uncontrolled inter-current 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. * Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.) * Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. * Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Tianjin **Country:** China **Facility:** Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences ## 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 ### 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: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10945 - Name: Leukemia - Relevance: HIGH - As Found: Leukemia - ID: M27585 - Name: Precursor Cell Lymphoblastic Leukemia-Lymphoma - Relevance: HIGH - As Found: Acute Lymphoid Leukemia - ID: M10951 - Name: Leukemia, Lymphoid - Relevance: HIGH - As Found: Lymphoid Leukemia - ID: M11220 - Name: Lymphoma - Relevance: LOW - As Found: Unknown - 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: T175 - Name: Acute Lymphoblastic Leukemia - Relevance: HIGH - As Found: Acute Lymphoblastic Leukemia - ID: T3533 - Name: Lymphoblastic Lymphoma - Relevance: HIGH - As Found: Acute Lymphoid Leukemia - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T3543 - Name: Lymphosarcoma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007938 - Term: Leukemia - ID: D000054198 - Term: Precursor Cell Lymphoblastic Leukemia-Lymphoma - ID: D000007945 - Term: Leukemia, Lymphoid ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000000903 - Term: Antibiotics, Antineoplastic - ID: D000000922 - Term: Immunotoxins - ID: D000018796 - Term: Immunoconjugates - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M2103 - Name: Inotuzumab Ozogamicin - Relevance: HIGH - As Found: Confirmation of - ID: M1346 - Name: Antineoplastic Agents, Immunological - 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: M4241 - Name: Immunotoxins - Relevance: LOW - As Found: Unknown - ID: M20855 - Name: Immunoconjugates - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000080045 - Term: Inotuzumab Ozogamicin ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427317 **Acronym:** DATATDM **Brief Title:** Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment **Official Title:** Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment and the Potential Role of Therapeutic Drug Monitoring in UK Infection Management #### Organization Study ID Info **ID:** 21HH7287 #### Organization **Class:** OTHER **Full Name:** Imperial College London ### Status Module #### Completion Date **Date:** 2027-03-19 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-03-19 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-19 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-03-27 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Imperial College London #### 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 primary aim of the study is to determine the proportion of individuals receiving beta-lactam antibiotics at Imperial College Healthcare NHS Trust in whom drug concentration targets are achieved. **Detailed Description:** To address the challenge of antimicrobial resistance (AMR) it is imperative that the current finite pool of antimicrobial agents is optimised, to maximise therapeutic success, limit the risk of drug toxicity, whilst minimising emergence of resistance. Outside of the critical care setting it is not known how many patients are receiving optimal drug concentrations for the treatment of infection. This study aims to assess whether antimicrobial targets are being achieved in these individuals and explore how clinical co-variates and outcomes may relate to this. Furthermore, it aims to identify priority groups and/or drugs where there are gaps in dose optimisation research and develop hypotheses which can be tested in observational studies. Eligible participants will be enrolled and observed during their management of infection at Imperial College NHS Trust. After providing informed consent their clinical data will be collected from electronic healthcare records and they will provide samples that will undergo drug concentration analysis. ### Conditions Module **Conditions:** - Infections, Bacterial - Pharmacokinetics - Drug Monitoring - Drug-Related Side Effects and Adverse Reactions ### Design Module #### Bio Spec **Description:** Sera, saliva, urine, nasal mucous, CSF, renal replacement fluid, CSF **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 323 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Determine the number of individuals receiving beta-lactam antibiotics at Imperial College Healthcare NHS Trust in whom drug concentration targets are achieved **Measure:** Determine the number of individuals receiving beta-lactam antibiotics at Imperial College Healthcare NHS Trust in whom drug concentration targets are achieved. **Time Frame:** 3 years #### Secondary Outcomes **Description:** Find the number of individuals receiving co-administered non-beta-lactam antibiotics in whom drug concentration targets are achieved. **Measure:** Find the number of individuals receiving co-administered non-beta-lactam antibiotics in whom drug concentration targets are achieved. **Time Frame:** 3 years **Description:** Show how clinical co-variates, co-administered medications and treatment outcomes relate to target attainment, and identify groups of patients in who therapeutic drug monitoring may be beneficial. **Measure:** Show how clinical co-variates, co-administered medications and treatment outcomes relate to target attainment, and identify groups of patients in who therapeutic drug monitoring may be beneficial. **Time Frame:** 3 years **Description:** Illustrate dynamic patterns of infection-related biomarkers which may indicate the presence/absence of treatment response. **Measure:** Illustrate dynamic patterns of infection-related biomarkers which may indicate the presence/absence of treatment response. **Time Frame:** 3 years **Description:** Show how drug-levels obtained through minimally invasive sampling and the use of residual specimens relate to blood, and how these could be used to inform individual dose-optimisation. **Measure:** Show how drug-levels obtained through minimally invasive sampling and the use of residual specimens relate to blood, and how these could be used to inform individual dose-optimisation. **Time Frame:** 3 years **Description:** Build a repository of real life PK-PD data which can be used to generate hypotheses and guide the development of interventional dose optimisation studies **Measure:** Build a repository of real life PK-PD data which can be used to generate hypotheses and guide the development of interventional dose optimisation studies **Time Frame:** 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 18 years of age or above. * Under follow-up for management of infection at Imperial College NHS Trust * Received a beta-lactam antibiotic within the last 48 hours (or are planned to start imminently). * Provides informed written consent see below, or lacks capacity to provide consent because of one of the following conditions (and declaration provided by personal consultee): * Delirium which may be caused or exacerbated by having an infection. * Suspected/confirmed central nervous system infection. * Critical illness requiring sedation and/or intubation and ventilation which is caused by or exacerbated by having an infection. Exclusion Criteria: * Less than 18 years of age * Severe anaemia (Hb \< 70g/l) * Platelets \< 50x10\^9/l, INR \>1.5 or other known blood clotting impairment * Patient with terminal diagnosis receiving palliative care input who may experience distress if approached for this study. * Enrolled in a clinical trial which stipulates exclusion from other studies including observational studies. * Patients with restricted liberty, prisoners or under legal protection. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** As per inclusion criteria ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Suzy Williams **Phone:** +44 (0) 20 3313 2732 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Richard Wilson, MPharm **Role:** CONTACT #### Locations **Location 1:** **City:** London **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Suzy Williams - **Phone:** +44 (0)20 3313 2732 - **Role:** CONTACT **Country:** United Kingdom **Facility:** Imperial College Healthcare NHS Trust **Status:** RECRUITING **Zip:** W12 0HS #### Overall Officials **Official 1:** **Affiliation:** Imperial College London **Name:** Alison Holmes, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000064419 - Term: Chemically-Induced Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC25 - Name: Substance Related Disorders ### 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: M30303 - Name: Drug-Related Side Effects and Adverse Reactions - Relevance: HIGH - As Found: Drug-Related Side Effects and Adverse Reactions - ID: M4722 - Name: Bacterial Infections - Relevance: HIGH - As Found: Infection, Bacterial - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown - ID: M30302 - Name: Chemically-Induced Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000001424 - Term: Bacterial Infections - ID: D000064420 - Term: Drug-Related Side Effects and Adverse Reactions ### 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: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427304 **Acronym:** ARNOLD **Brief Title:** Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure **Official Title:** Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure #### Organization Study ID Info **ID:** 2023-A01313-42 #### Organization **Class:** OTHER **Full Name:** Gérond'if ### Status Module #### Completion Date **Date:** 2027-12-02 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-05-02 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-04-24 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Gérond'if #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Tne aim purpose of this observational, multicentre and propective study is to determine the prevalence of cardiac amyloidosis in geriatric patients aged 80 years and older hospitalized within the last 12 months for heart failure with left ventricular hypertrophy (septum ≥ 12 mm) on echocardiography **Detailed Description:** Patients recruitment will be curry out in 31 geriatric or cardiologic centres. Patients will be recruited for 24 months. Each patient will participate in the study for 12 months (baseline visit, follow-up phone calls every 3 months up to 12 months i.e., at 3, 6, 9 and 12 months). The following data will be collected at teh baseline visit: Medical history, demography, clinical data, frailty status assessed by Fried, Triage Risk Screening Tool (TRST), triggers for cardiac decompensation, biological examination, genetic testing, echocardiographic data and other data. Bone scanning with 99mTc-DPD or 99mTc-HMDP (early or late time with SPECT will be done during hospitalization or after discharge depending on availability at the imaging centre. The results of each examination will be evaluated to establish the existence and degree of fixation in the myocardium and to determine its distribution. Follow-up phone s will be conducted every 3 months up to 12 months to collect hospitalizations for heart failure, hospitalizations for other cardio-vascular events, hospitalizations for non-cardiac events, admission to nursing homes or long-term care (LTC) facilities and death ### Conditions Module **Conditions:** - Cardiac Amyloidosis **Keywords:** - Cardiac amyloidosis - Heart failure with left ventricular hypertrophy - Positive bone scintigraphy ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 637 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Measure:** Assessment of the number of patients with cardiac amyloidosis according bon scintigraphy **Time Frame:** At inclusion #### Secondary Outcomes **Description:** The Charlson Comorbidity Index (CCI) assesses the level of comorbidity by considering the level of severity of 19 predefined comorbid disorders and the number of disorders present among them. **Measure:** Assessment of commorbidity risk according Charlson Comorbidity Index (CCI) **Time Frame:** At inclusion **Description:** Katz Index of Independence in Activities of Daily Living is an unabbreviated scale title. This Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. Patients are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment. **Measure:** Assessment of the degree of patient dependence according Katz Index of Independence in Activities of Daily Living (ADL) **Time Frame:** At inclusion **Description:** The Mini-Mental State Examination is an unabbreviated scale title. This scale was developed as a brief screening tool to provide a quantitative evaluation of cognitive impairment and to record cognitive changes over time. The measure yields a total score of 30. A score of 23 or less is the generally accepted cutoff point indicating the presence of cognitive impairment. Levels of impairment have also been classified as none (24-30); mild (18-23) and severe (0-17) **Measure:** Measuring cognitive impairment according Mini-Mental State Examination (MMSE) score **Time Frame:** At inclusion **Description:** This questionnaire is an unabbreviated score title, it was originally developed and validated in French (4 items of neuropathic pain). It was identified as one of the most suitable neuropathic pain screening tools for clinical use: * Sensitivity: Ranges from 75-98%. Proven high sensitivity for central neuropathic pain and polyneuropathies. Sensitivity is low for tigeminal neuralgia. Moderate sensitivity for detecting a neuropathic component of pain in people with chronic pain. * Specificity: Ranges from 37-96%. **Measure:** Estimating the probability of neuropathic pain according "DN4 Questionnaire" **Time Frame:** At inclusion **Description:** This is an unabbreviated scale title. Assessment of 5 dimensions: * 0, 1 or 2 pathological dimensions = lack of frailty * 3, 4 or 5 pathological dimensions = presence of frailty **Measure:** Assessment of physical frailty according Fried scale **Time Frame:** At inclusion **Description:** This is an unabbreviated scale title. * if SEGA score \< ou = 8 : Not very frail * if it contained in the interval \[9;11\] : Rather frail * if it \> ou = 12 : Very frail **Measure:** Assessment of Failty status using the Short Emergency Geriatric Assessment (SEGA) **Time Frame:** At inclusion ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged ≥ 80 years * Hospitalised for decompensation of heart failure in the last 12 months * Subjects with hypertrophy of the septum or left ventricle at cardiac echography (defined as ≥ 12 mm) * Subjects able to undergo a bone scintigraphy scan * Subjects willing to participate Exclusion Criteria: * Subjects refusing to participate * Subjects admitted to palliative care unit. * Subjects under guardianship * Subjects with a definite diagnosis of cardiac amyloidosis **Minimum Age:** 80 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - OLDER_ADULT **Study Population:** Patients with cardiac amyloidosis expressed by a positive bone scintigraphy. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Isabelle Dufour **Phone:** +33 (0) 185781011 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Prisca Lucas, MPH PhD **Phone:** +33 (0)185737323 **Role:** CONTACT #### Locations **Location 1:** **City:** Paris **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Olivier Hanon, MD PhD - **Phone:** +33 (0)144083503 - **Role:** CONTACT **Country:** France **Facility:** Geriatric Department, Broca Hospital **State:** IIe-de-France **Zip:** 75013 #### Overall Officials **Official 1:** **Affiliation:** Geriatric Department, Broca hospital **Name:** Olivier Hanon, MD PhD **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000057165 - Term: Proteostasis Deficiencies - ID: D000008659 - Term: Metabolic 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: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M9421 - Name: Heart Failure - Relevance: HIGH - As Found: Heart Failure - ID: M10035 - Name: Hypertrophy - Relevance: LOW - As Found: Unknown - ID: M4021 - Name: Amyloidosis - Relevance: HIGH - As Found: Amyloidosis - ID: M19658 - Name: Hypertrophy, Left Ventricular - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - 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: D000006333 - Term: Heart Failure - ID: D000000686 - Term: Amyloidosis ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427291 **Brief Title:** Clinical Study of T3011 Intravesical Instillation for Treatment of NMIBC Patients **Official Title:** A Phase I, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Evaluate the Safety and Efficacy of T3011 in Patients With BCG-Failure Non-Muscle-Invasive Bladder Cancer (NMIBC) #### Organization Study ID Info **ID:** MVR-T3011-ES-EC61-UC #### Organization **Class:** OTHER **Full Name:** Fudan University ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-09-21 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Fudan University #### Responsible Party **Investigator Affiliation:** Fudan University **Investigator Full Name:** Ding-Wei Ye **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is a prospective, open-label, single-arm investigator-initiated clinical study. It is used to evaluate the safety and efficacy of T3011 intravesical instillation in patients with BCG-failure high-risk non-muscle invasive bladder cancer (NMIBC) ### Conditions Module **Conditions:** - Bladder Cancer **Keywords:** - high-risk non-muscle invasive bladder cancer (NMIBC) - BCG failure or intolerance ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** T3011 with the dose of 5 x 10\^7 PFU, 5 x 10\^8 PFU or 2 x 10\^9 PFU is administered via intravesical instillation, once a week (QW) for the first 12 weeks and then every 2 weeks (Q2W) until 12 months. **Intervention Names:** - Biological: Herpes virus T3011 injection **Label:** Herpes virus T3011 injection **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Herpes virus T3011 injection **Description:** T3011 will be instilled in the entire solution volume of 50ml, and be will be left in the bladder for at least 1 hour, no more than 2 hours. After competing instillation, the patients should be instructed to drink at lest 1000mL of water **Name:** Herpes virus T3011 injection **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Defined as the rate of Complete response or relapse-free survival at 3, 6, 9 and 12 months after first study drug administration **Measure:** CR rate or relapse-free survival rates at 3, 6, 9 and 12 months after the first study dose **Time Frame:** 3, 6, 9 and 12 months after first study dose **Description:** Defined as relapse-free survival time **Measure:** Recurrence-free survival, RFS **Time Frame:** Up to 2 years **Description:** Defined as time to progression-free survival **Measure:** Progression-free survival, PFS **Time Frame:** Up to 2 years **Description:** Defined as the rate at which radical cystectomy occurs **Measure:** Incidence of radical cystectomy **Time Frame:** Up to 2 years **Description:** Defined as survival rate at 5 year of administered treatment **Measure:** 5-year survival rate **Time Frame:** Up to 5 years **Description:** Evaluation standard is CTCAE V5.0 **Measure:** Adverse Events, AE **Time Frame:** up to 30 days after completion of treatment **Description:** Evaluation standard is CTCAE V5.0 **Measure:** Serious Adverse Event, SAE **Time Frame:** up to 30 days after completion of treatment **Description:** Defined as a toxic reaction related to the test drug occurring within the first cycle of treatment, i.e. within 28 days of the first instillation **Measure:** Dose-limiting toxicity (DLT) events **Time Frame:** First cycle of treatment, i.e. within 28 days of first instillation **Description:** Abnormal clinically significant vital signs and their incidence **Measure:** Abnormal clinically significant vital signs and their incidence **Time Frame:** Up to 1 years **Description:** Abnormal clinically significant physical findings and their incidence **Measure:** Abnormal clinically significant physical findings and their incidence **Time Frame:** Up to 1 years **Description:** Abnormal clinically significant laboratory findings and their incidence **Measure:** Abnormal clinically significant laboratory findings and their incidence **Time Frame:** Up to 1 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Participants who understand and voluntarily sign the written ICF, and are willing and able to comply with all trial requirements. 2. Male or female, aged ≥ 18 years at the time of signing the ICF. 3. Participants with a histologically confirmed diagnosis of NMIBC (Ta, T1 and/or Tis). 4. Participants with high risk NMIBC who have been diagnosed by cystoscopy, urine cytology, and histopathology within 8 weeks prior to the first dose administration and have failed or intolerant to BCG treatment after TURBT surgery, and are not suitable or willing to undergo radical cystectomy. 5. BCG-failure include BCG refractory, recurrence or relapsing after BCG treatment, BCG unresponsive and BCG intolerant. 6. All tumors should have no visible tumors after transurethral bladder tumor resection (TURBT). If meeting the requirements for secondary resection, secondary resection need to be done. It is recommended to perform secondary resection if the following conditions are met: the first TURBT is insufficient, there is no muscle tissue in the first resection specimen (excluding low-grade \[Ta G1\] tumors and pure in situ cancers), T1 stage tumors, and high-grade \[G3\] tumors (excluding pure in situ cancers); Secondary resection is recommended to be performed 2-6 weeks after the first resection; Participants undergoing secondary resection must meet the requirement of no visible tumors after surgery. 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 8. Expected survival ≥3 months. 9. Sufficient hematology and terminal organ function were met within 4 weeks prior to the first s treatment, for example, having sufficient bone marrow reserves and organ function: * Hematology (hematopoietic growth factor treatment or blood transfusion should not be given within 2 weeks prior to the treatment of study drug): ANC≥1.5×10\^9/L, PLT count ≥75×10\^9/L, Hemoglobin (HGB) ≥90 g/L. * Renal function: Creatinine clearance ≥60 mL/min (based on Cockcroft-Gault equation for calculation) * Hepatic function: Serum total bilirubin (TBIL) ≤1.5×ULN, Aspertate aminotransferase (AST) and alanine transaminase (ALT) ≤3×ULN * Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN; Activated partial thromboplastin time (aPTT) ≤1.5×ULN 10. Women with fertility should agree to use contraceptive measures (such as intrauterine devices (IUDs), contraceptives, or condoms) during the study period and within 6 months after the end of the study; Within 7 days prior to enrollment in the study, the serum or urine pregnancy test was negative and must be a non lactating patient; Men should agree to patients who must use contraceptive measures during the study period and within 6 months after the end of the study period. Note: A female subject with fertility is defined as a female subject who has not reached a postmenopausal state after menarche (continuous amenorrhea for at least 12 months, with no other clear cause other than menopause), and has not undergone surgery (i.e. bilateral ovariectomy, fallopian tube resection, and/or hysterectomy) or other causes determined by the researcher (such as underdeveloped Mullerian tubes) leading to permanent infertility. Exclusion Criteria: Patients meeting one or more of the following criteria will be excluded: 1. The diagnosis is confirmed as muscle invasive bladder cancer (T2-T4). 2. Patients with concurrent upper and lower urinary tract epithelial carcinoma, lymph node metastasis, or distant metastasis. 3. Pregnant and lactating female patients. 4. Having major surgery within 4 weeks prior to the first dose of the study drug, or anticipate the need for major surgery rather than diagnosis after enrolling the study. 5. In addition to immediate instillation therapy after TURBT surgery, anti-tumor drug treatments such as chemotherapy, radiation therapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, etc. have been received within 4 weeks prior to the first dose of the study drug (excluding nitroso urea, mitomycin C, oral fluorouracil, small molecule targeted drugs, and traditional Chinese medicine with anti-tumor indications). Nitrso urea or mitomycin C is within 6 weeks prior to the first use of the study drug, and oral fluorouracil and small molecule targeted drugs are within 2 weeks prior to the first use of the study drug or within 5 half-lives of the drug (whichever is longer). Traditional Chinese medicine with anti-tumor indications is within 2 weeks prior to the first dose of the study drug. 6. Patients who have received systemic corticosteroids (prednisone\>10mg/day or equivalent doses of similar drugs) or other immunosuppressive treatments within 14 days prior to the first dose of the study drug; Excluding the use of local, ocular, intra-articular, intranasal, and inhaled corticosteroids for treatment; Short term use of corticosteroids for preventive treatment (such as preventing contrast agent allergies). 7. Taking live attenuated vaccines within 4 weeks prior to the first dose of the study drug, or it is expected that live attenuated vaccines will be vaccinated during the study period. 8. Participants who have previously received oncolytic virus therapy (such as T-vec, T3011, etc.), gene therapy, cell therapy, and tumor vaccines. 9. Participants have a history of splenectomy or organ transplantation. 10. Participants with the malignant tumors other than the disease treated in this study, except for the following: * Malignant tumors that have undergone treatment with the aim of cure, at least more than 5 years from the drug treatment, have no known active diseases, and have a low potential risk of recurrence; * Fully treated non-melanoma skin cancer or malignant freckle like nevi with no evidence of disease; * In situ cancer with sufficient treatment and no evidence of disease. 11. All toxicities caused by prior radiotherapy, chemotherapy or other treatments have recovered to Grade ≤1 (CTCAE 5.0) (except for alopecia), including but not limited to urinary tract infection, urinary tract irritation, and gross hematuria. 12. Indwelling ureteral stent or having a history of bladder ureteral reflux disease. 13. Major cardiovascular diseases, such as New York Heart Association heart disease (grade II or higher), myocardial infarction within the first three months of enrollment, unstable arrhythmia or unstable angina. 14. Having the history of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wagner's granulomatosis, Sjogren's syndrome, Guillain Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Except for patients with hypothyroidism or diabetes who have good control of alternative treatment. 15. Persistent or active infections exist, and drug treatment and control are still not ideal; Including but not limited to: active pulmonary tuberculosis, non negative AIDS virus (HIV) antibody, positive hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA) quantity ≥ the lower limit of the laboratory test in the research center, hepatitis C virus antibody (HCV Ab) positive and hepatitis C virus RNA quantity ≥ the lower limit of the laboratory test in the research center. 16. Participants who require oral or intravenous use of anti herpesvirus drugs during the study period (including but not limited to acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir, foxinkane, cedofovir, etc.) (excluding local use such as topical use). 17. Participants with the history of allergic reactions to HSV-1, IL-12, or anti PD-1 antibodies and similar biological components, or those known to have allergic reactions to any component of T3011. 18. Fever above 38.5 ℃ with no explained reason during the screening period, washout period/baseline period, or on the day of administration (the researcher determines that fever caused by tumors can be included), according to the researcher's judgment, may affect the patient's participation \\in this trial or interfere with the evaluation of efficacy. 19. In the period of recurrent herpes simplex virus infection, there are corresponding clinical manifestations, such as lip herpes, herpetic keratitis, herpetic dermatitis, genital herpes, etc. 20. Participants who have previously developed non infectious pneumonia/interstitial pneumonia or are intolerant to immunotherapy drugs (including but not limited to anti PD-1/PD-L1 antibodies) (including but not limited to developing ≥ grade 3 immune related adverse events \[irAEs\]) (excluding endocrine related irAEs that can be stably controlled through hormone replacement therapy). **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Dingwei Ye, Doctor **Phone:** 021-64175590 **Role:** CONTACT #### Locations **Location 1:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Dingwei Ye, Doctor - **Phone:** 021-64175590 - **Role:** CONTACT **Country:** China **Facility:** Fudan University Shanghai Cancer Center **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Fudan University **Name:** Dingwei Ye, Doctor **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014571 - Term: Urologic Neoplasms - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000001745 - Term: Urinary Bladder Diseases - ID: D000014570 - Term: Urologic 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: M5030 - Name: Urinary Bladder Neoplasms - Relevance: HIGH - As Found: Bladder Cancer - 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: M5026 - Name: Urinary Bladder 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 ### Condition Browse Module - Meshes - ID: D000001749 - Term: Urinary Bladder Neoplasms ### 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: M4793 - Name: BCG Vaccine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427278 **Brief Title:** Implication of Long Non-coding RNA CCDC144NL-AS1/Micro RNA-143-3p Axis Expression Level as Novel Signature in Colorectal Cancer **Official Title:** CCDC144NL-AS1/Hsa-miR-143-3p/HMGA2 Interaction: In-silico and Clinically Implicated in CRC Progression, Correlated to Tumor Stage and Size in Case-controlled Study; Step Toward ncRNA Precision #### Organization Study ID Info **ID:** RHDIRB2020110301/2022 #### Organization **Class:** OTHER **Full Name:** Ain Shams University ### Status Module #### Completion Date **Date:** 2023-01-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-10-01 **Type:** ACTUAL #### Start Date **Date:** 2019-08-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ain Shams University #### Responsible Party **Investigator Affiliation:** Ain Shams University **Investigator Full Name:** Prof. Nadia M. Hamdy, Ph.D. **Investigator Title:** professor of biochemistry and molecular biology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Elucidate the role of lncRNA CCDC144NL-AS1, hsa-miR-143-3p, and HMGA2 protein as non-invasive epigenetic molecular biomarkers in liquid biopsy of CRC Egyptian patients, individually or as an interaction arm and in comparison, to the conventional protein TMs. In addition, the investigators investigated the potential role of lncRNA CCDC144NL-AS1 as a mediator for development and/or progression of the cancer phenotype as well as CRC metastasis and its relation to both hsa-miR-143-3p and HMGA2, clinically and in silico. **Detailed Description:** 1. Introduction 1.1. Background Colorectal cancer (CRC) is one of the malicious malignancies worldwide, accounting for nearly 8 % of all annual deaths \[1\]. It is considered Egypt's 7th most prevalent cancer, representing about 3.47 % of male tumors and 3 % of female tumors, respectively \[2\]. By 2030, there will be an estimated 60 % increase in incidence and mortality for CRC globally \[3\]. Early-stage CRC is usually asymptomatic, but when symptoms do manifest, timely detection is essential because any delay in the diagnosis may increase mortality rates \[4\]. 1.2. Problem Surgical resection could cure 90 % of CRCs in the early stages. Nevertheless, the majority of patients frequently have poor prognosis since they are detected at an advanced stage \[5\]. Although colonoscopy tissue biopsy is commonly used for CRC diagnosis, yet, it is an invasive high-risk test, not convenient to be implemented in routine medical examination for longitudinal monitoring or prognosis and is considered partially representative of inter-metastatic or tumoral genetic heterogeneity \[6\]. The classical circulating tumor biomarkers (TMs) as carbohydrate antigen 19-9 (CA19-9) and carcinoembryonic antigen (CEA) \[7\] are used as follow-up or prognosis markers, despite of their limited sensitivity and specificity \[8\]. Therefore, there is an urgent need for more efficient prognostic molecular biomarkers which could be "epi/genetic molecular marker(s)" that have 2 benefits, first, harbor potential therapeutic target(s) and second, augment classical circulating TMs, in order to improve CRC precision. Liquid biopsy has emerged as a minimally invasive diagnostic tool to analyze tumoral genetic and epigenetic molecular markers released into the circulation. Liquid biopsy captures, better, tumor genetic heterogeneity, reflecting the dynamic picture of tumor molecular landscape with lower processing time and lower cost than tissue biopsy \[9\]. Long non-coding RNAs (lncRNAs) are RNA molecules with \>200 nucleotides length, that regulate gene expression at the transcriptional, post-transcriptional, and translational levels, but cannot code for proteins synthesis \[10-12\]. Multiple cancer types exhibit deregulations of lncRNAs, which are involved in all cancer hallmarks, including cancer genesis, progression, and metastasis \[13,14\]. Emerging studies revealed several lncRNAs are implicated in CRC tumorigenesis, metastasis, and progression \[15,16\]. Beyond their potential for diagnosis, lncRNAs would also serve as possible therapeutic targets \[17\]. Coiled-lncRNA Coil Domain Containing 144 N-Terminal-Like antisense 1 (CCDC144NL-AS1) located on the 17p11.2 human chromosome, is a novel oncogenic lncRNA recently reported to be involved in carcinogenesis \[18\]. LncRNA CCDC144NL-AS1 was found to be upregulated in various cancers including gastric cancer (GC) \[18\], hepatocellular carcinoma (HCC) \[19\], non-small cell lung cancer (NSCLC) \[20\], ovarian cancer (OC) \[21\], osteosarcoma \[22\], and CRC \[23\]. However, its clinical role as biomarker for CRC needs to be elucidated. MicroRNAs (miRNAs or miRs) are single-stranded, small RNA molecules that are 18-25 nucleotides length \[24\]. They have a regulatory function in a variety of physiological processes, involving cell differentiation, growth, apoptosis, immunological response, hematopoiesis, and proliferation \[25\]. Several studies have shown miRs have crucial role in both initiation and progression of CRC, besides their potential as molecular biomarkers and possible therapeutic hits \[26-28\]. Hsa-miR-143 located on the human chromosome 5q32 \[29\] is a tumor-suppressor miR reported to be down-regulated via miR-mediated post-transcriptional gene silencing in several human cancers including prostate cancer \[30\], cervical cancer \[31\], OC \[32\], and B-cell lymphoma \[33\]. The 3' arm of the miR precursor product, hsa-miR-143-3p is down regulated in CRC and if it would contribute to CRC initiation \[34\] will be studied currently clinically. LncRNA-miR interaction plays an essential role during various cancer development \[35,36\]. CCDC144NL-AS1 was reported to act as competing endogenous RNA (ceRNA) for hsa-miR-143-3p during GC progression, via competing with the common binding regions of miRs, in order to sequester them and therefore, alter the expression of miRs downstream target genes or proteins \[18\]. Being approved experimentally by Fan et al. \[37\] in GC lncRNA CCDC144NL-AS1 upregulation in GC tissues and sponging hsa-miR-143-3p followed by upregulated expression of its direct endogenous target protein. Similarly, the clinical correlation between lncRNA CCDC144NL-AS1 and hsa-miR-143-3p in CRC patients' peripheral blood samples, that haven't been estimated previously, could further clarify our understanding of CRC molecular pathogenesis and proof the cancer findings documented in silico. High Mobility Group AT-hook 2 (HMGA2) gene encoded by 5 exons and an open reading frame of 330 base pair, is found at human chromosome band 12q13-15 \[38\]. The adult normal cell's HMGA2 protein concentration is minimal or absent under normal physiological conditions, but it is highly expressed during embryogenesis \[38\] and carcinogenesis \[39,40\]. Patients with CRC who have HMGA2 overexpression are experiencing worse prognosis \[41\]. HMGA2 takes part in almost every stage of biological activity of CRC, including cell division, proliferation, apoptosis, senescence, tumor invasion, epithelial-tomesenchymal transition (EMT), DNA repairing mechanism, and stem cell ability of self-renewal \[42\]. HMGA2 in osteosarcoma, was reported to be positively modulated by CCDC144NL-AS1 \[22\]. 1.3. Aim The oncogenic lncRNA CCDC144NL-AS1 if being involved in CRC pathogenesis, by acting as a ceRNA/sponging the tumor suppressor hsamiR-143-3p, and further, upregulating the expression of its endogenous target HMGA2 as an interaction arm will be highlighted in the current study. 1.4. Objectives Elucidate the role of lncRNA CCDC144NL-AS1, hsa-miR-143-3p, and HMGA2 protein as non-invasive epigenetic molecular biomarkers in liquid biopsy of CRC Egyptian patients, individually or as an interaction arm and in comparison, to the conventional protein TMs. In addition, we investigated the potential role of lncRNA CCDC144NL-AS1 as a mediator for development and/or progression of the cancer phenotype as well as CRC metastasis and its relation to both hsa-miR-143-3p and HMGA2, clinically and in silico. 2. Subjects 2.1. Sample size and power of the study Based on the previous study by Zhang et al. in 2019 lncRNA CCDC144NL-AS1 was normally distributed with a standard deviation (3.2) and large effect size (0.85) \[43\]. If the true differences between the CRC group and the control group means are 1 and 3.3, respectively, the study group sizes are 34 patients and 34 control subjects. Total sample size was 68 cases, which was increased by 25 % for expected losses, and total sample was finally 90 subjects, 60 CRC subjects and 30 control (2:1). This is to be able to reject the null hypothesis, that the population means of the experimental groups are equal with probability (power) of 0.8. The Type I error probability associated with this test of this null hypothesis is (0.05). Sample size estimation was performed by G power\* sample size online calculator http://www.gpower.hhu.de/en.html, depending on two-sided confidence level 95 %. 2.2. Study design Case-controlled retrospective mono-center study. 2.3. Institutional Review Board (IRB) statement The Research Ethics Committee of the Faculty of Pharmacy, Ain Shams University, granted ethical permission to conduct the study, 2022. All participants (controls or patients) were fully cognizant of the purpose of the study and signed a written, ethically-approved, informed consent (I⋅C) form. This study was conducted in accordance to the Declaration of Helsinki Guidelines approved in 2013 \[44\]. 2.4. Study participants 2.4.1. Patients group A total of 60 primary CRC treatment-naïve Egyptian patients admitted to the Dar Al Shefa Hospital, Cairo, Egypt, were enrolled in the study. 2.4.1.1. Patients' inclusion criteria. Patients visiting the Colonoscopy Unit for colorectal examination, suffering from variable colonic symptoms, including the CRC alarming symptoms, constipation, abdominal pain, rectal bleeding, and sudden weight loss. CRC diagnosis was clinically confirmed by colonoscopy, abdominal radio-imaging, and histopathologically. 2.4.1.2. Patients' exclusion criteria. Patients suffering from inflammatory disorders, hematological disorders, any cancer other than CRC, or those receiving chemotherapy, radiation, or have undergone surgery, patients with hematological disorders, or any cancer other than CRC. Individuals with inadequate data or missing histopathological diagnosis, as well as those with distant metastases at the time of diagnosis were excluded from the study. 2.4.2. Control group 30 age-matched and sex-matched apparently healthy volunteers, not receiving any medications or suffering from any disease, age range 30-60 years, were included as controls, male-to-female 1:1 (15/15). Control subjects were recruited randomly during routine check-up examinations for themselves or during blood donation. 2.4.3. Patients demographic, clinical, and pathological data The patients' demographic data including age, gender, smoking status, and the patient full history, retrieved from the hospital medical records. In addition to patients' colorectal surgery history, the complete family history of cancer, as well as history of diabetes mellitus (D.M) and hypertension (HTN) were recorded to determine the non communicable diseases status/impact. From patients' files, the following chemistry lab results were recorded, for statistical correlations, CEA, CA19-9 and routine biochemical testing of liver function profiling of alanine aminotransaminase (ALT), aspartate aminotransaminase (AST), and serum albumin, kidney function tests including serum creatinine and serum urea. Hemoglobin (Hgb) as well as prothrombin time (PT), platelet count, lymphocytes count, lactate dehydrogenase (LDH), and C-reactive protein (CRP) were all measured in blood at the Clinical Biochemistry Lab, Dar Al Shefa Hospital, Cairo, Egypt. Tumor site, tumor size, tumor type if mucinous or not, LN metastasis (LNM), tumor invasion or vascular invasion, tumor differentiation, tumor grade, tumor-node-metastasis (TNM) staging, inflammation status as inflammatory bowel disease (IBD), and CRC locations if colonic or rectal, as well as if transverse, sigmoid, rectosigmoid, and rectal, were collected from the patients' files at the Statistics Unit at Dar Al Shefa Hospital, Cairo. Pathological records according to the American Joint Committee (AJCC) on Cancer 2010 criteria \[45\] were collected as well. Patients were categorized into three stages from II to IV, Stage I/II is the local cancer with no LN involvement (N0), Stage III where LN involvement (N1-x) is there, and Stage IV with distant metastasis (M1). CRC staging was determined by the colonoscopy results, abdominal radiography, pathological findings, and clinical evaluation, where the early stage T2 indicates invasion of the muscularis propria by the tumor, T3 indicates the tumor penetration to the subserosa and the muscularis propria, while late tumor stage T4 indicates that it has penetrated the rectum or several colon layers. 3. Methods 3.1. In silico database(s) search and analysis (accessed on October 2021 and revised July 2023) 3.1.1. Identification of the investigated ncRNAs by bioinformatics The HUGO Gene Nomenclature Committee (HGNC) https://www. genenames.org/ supported by National Human Genome Research Institute grant, National Center for Biotechnology Information (NCBI) https://www.ncbi.nlm.nih.gov/, NCBI Genome Data Viewer (GDV) \[46\] (USA.gov) and Ensembl Databases https://www.ensembl.org/index. html for human ncRNAs genes characterization (Ensembl release 109) CCDC144NL-AS1 and MIR-143 are shown in Table 1. 3.1.2. LncRNA disease v2.0 expression The LncRNA and Disease Database (version 2.0) \[47\] http://www.rnanut.net/lncrnadisease/index.php/home to explore lncRNA CCDC144NL-AS1 expression in different cancer types retrieved from validated experimental results in publications or predicted http://www. rnanut.net/lncrnadisease/index.php/home/detail/LDA0044869. 3.1.3. Expression via ENCORI pan-cancer analysis platform \[48\] https://rnasysu.com/encori/panCancer.php of miR, lncRNA or genes across 32 types of Cancers. The expression box-plot values of genes from RNA-seq data were scaled with log2(FPKM +0.01), while the ones from miRNA-seq data were scaled with log2(RPM + 0.01). 3.1.4. Association via miREnvironment database \[49,50\] http://www.cuilab.cn/miren#fragment-1of curated and collected experimentally supported miRNA and various environmental factors (394 factor) interplay and their associated phenotypes (June-28, 2011, the original miREnvironment Database was released, Last update: Sep-9, 2012) for analysis for has-miR-143-3p as prediction of association between environmental factors and human disease. 3.1.5. Interaction via the lncRNASNP2-human \[51\] The lncRNA CCDC144NL-AS1 or HMGA2 as non-conserved targets of miRNA:hsa-miR-143 http://www.noncode.org/gene_trans_search.php search_type=keyword\&keyword=CCDC144NL-AS1\&sbt=Search. 3.1.5.1. Binding targets interaction. Binding targets for hsa-miR-143-3p predicted via database RNAhybrid 2.2 https://mybiosoftware.com/rna 22-v2-microrna-target-detection.html \[52\], http://bibiserv.cebitec.uni -bielefeld.de/rnahybrid \[53\] and RNA22 v2 microRNA target detection https://cm.jefferson.edu/rna22/Interactive/ by Jefferson Computational Medicine Center (CMC) \[54\] to predict hsa-miR-143-3p interaction with either lncRNA CCDC144NL-AS1 or HMGA2 as target, and database RNA22 v2 microRNA target detection. 3.1.6. Functional enrichment analysis, targeted pathways and heatmaps 3.1.6.1. KEGG targeted pathways, clusters/heatmap using DIANA. Reverse Search \[55\] https://dianalab.e-ce.uth.gr/html/universe/index. php?r=mirpath to identify in KEGG pathways-involved miRs using Mirpath, using the DIANA-TarBase v7.0 Heatmap with cluster dendrogram with statistically significant results in red by a posteriori analysis method after an enrichment analysis is performed, p value threshold set at 0.05 and MicroT threshold set at 0.8 (Accessed on July 25th 2023). Functional enrichment analysis using STRING version 11.5 https://string-db.org/ \[56\]. Finally, using the Genome Browser (UCSC) \[57\] Dec. 2013 initial release; June 2022 patch release 14, selected top genes Targets of HMGA2 interactions and pathways from curated databases and textmining https://genome.ucsc.edu/cgi-bin/hgGateway (Accessed on July 25th, 2023). 3.2. Blood samples Five milliliters of peripheral venous blood were withdrawn from controls and CRC patients, under strict sterile conditions, following standard international biosecurity safety procedures, into polymer gel clot activator vacutainers (Greiner Bio-One GmbH, Australia). At room temperature (25 ◦C), completely coagulated samples were centrifuged at 4000 rpm for 10 min. Sera obtained were aliquoted into three DNase/ RNase free Eppendorf tubes and stored at -80 ◦C for molecular analysis. 3.2.1. Total RNA extraction Using the miRNeasy Mini kit (Cat. No.217004; Qiagen, Hilden, Germany) according to the manufacturer's protocol, from serum samples, RNA extraction was done. The isolated RNA was eluted in 40 μL of RNase-free water. 3.2.2. Quantitation of purified RNA including miRNAs Using a NanoDrop® 1000 spectrophotometer (Thermo Scientific, Wilmington, DE, USA) the concentration and purity of all RNA samples were determined. Absorbance at 260 nm was used to measure the conc. of RNA in the sample, whereas 260/280 and 260/230 nm ratios were used to evaluate RNA purity. After quantification, the isolated and eluted RNA was stored at -80 ◦C in aliquots. 3.2.3. Reverse transcription and measurement of ncRNAs expression 3.2.3.1. cDNA synthesis and measurement of lncRNA CCDC144NL-AS1 expression using qRT-PCR. Total RNA was reverse transcribed into cDNA using the Xpert cDNA Synthesis Kit (Cat. No. GK80.0100; Grisp Research Solutions, Rua Alfredo Allen, Portugal) containing Xpert Reverse Transcriptase (RNase H-), RNA-dependent DNA polymerase appropriate for cDNA synthesis from long RNA templates, following the manufacturer's protocol. The synthesized cDNA was then stored at - 20 ◦C till qRT-PCR. The expression of lncRNA CCDC144NL-AS1 was measured using the Xpert Fast SYBR (Cat. No. GE20.0100; Grisp Research Solutions, Rua Alfredo Allen, Portugal) in accordance with the manufacturer protocol. The primer RT2 lncRNA qPCR Assay for Human CCDC144NL-AS1 (Hs04941765 m1, Cat. No. 4426961) was used to assess the level of expression of the lncRNA CCDC144NL-AS1. The human GAPDH primer (LPH31725A-200, Cat. No. 330701) was used as endogenous control to normalize the expression of lncRNA CCDC144NLAS1. 3.2.3.2. cDNA synthesis and measurement of hsa-miR-143-3p expression using qRT-PCR. The miRCURY LNA RT Kit was used for cDNA synthesis (Cat. No.339340, Qiagen, Hilden, Germany) as proposed by the manufacturer's instructions. The resulting cDNA was kept at - 20 ◦C until quantification. qRT-PCR was used to measure the expression of the hsamiR- 143-3p using the miRCURY LNA miRNA PCR Assay (Cat. No. 339306, Qiagen, Hilden, Germany). The primer SNORD38B (hsa) miRCURY LNA miRNA PCR Assay (YP00203901, Cat. No. 339306) was used as endogenous control to normalize the expression of hsa-miR-143-3p. The reaction was carried out using the PCRmax Eco™48 qRT-PCR system (PCRmax, Staffordshire, USA). Primers sequences are listed in Table 2. All these primers were designed by Qiagen https://www.qiagen.com/workflow-configurator/ workflows intcmp=CM_QF_WFC_1121_OTHERS_QB_nav_products, except for lncRNA CCDC144NL-AS1 that was obtained from Thermofisher https://www.thermofisher.com/taqman-gene-expression/pr oduct/Hs04941765_m1 (Accessed on October 2021). The RNA relative expression was computed and normalized as fold change using the cycle threshold (Ct) method (2- ΔΔCt) with GAPDH or SNORD38B (hsa) as the internal control for lncRNA CCDC144NL-AS1 and hsa-miR-143-3p, respectively. ΔCt was determined by subtracting the Ct values of GAPDH and SNORD38B (hsa) from those of the lncRNA CCDC144NL-AS1 and hsa-miR-143-3p, respectively; where ΔΔCt = ΔCt cancer samples - ΔCt control samples \[58\]. 3.2.4. Quantification of HMGA2 protein concentration by ELISA HMGA2 protein concentration was measured in serum samples by commercially available ELISA kits from Bioassay Technology Laboratory (Cat.No. E7513Hu, Jiaxing, China) according to the manufacturer's instructions. The reaction is based on pre-coating the ELISA plate with Human HMGA2 antibody and HMGA2 present in added samples binds to antibodies coating the wells. Biotinylated human HMGA2 antibody was added to bind HMGA2 in samples. A second detector antibody was then added to bind the biotinylated HMGA2 antibody. A substrate solution was added that reacts with the enzyme-antibody-target complex to produce a measurable signal measured at 450 nm. 3.2.5. Indices and ratios 3.2.5.1. Body mass index (BMI kg/m2) was calculated in kg/m2 for each participant using the website https://www.nhlbi.nih.gov/health /educational/lose wt/BMI/bmicalc.htm. Normal weight individuals have BMI of 18.5-24.9 kg/m2, overweight BMI as 25-29.9 kg/m2, and 30 kg/m2 or more for obesity. 3.2.5.2. Platelets-to-lymphocytes ratio (PLR) was calculated by dividing the patient platelet count (x103 cell/μL) by the lymphocyte count (x103 cell/μL). PLR is an inflammation indicator and immune response-related predictor that has a stronger link with inflammatory diseases severity than the neutrophils-to-lymphocytes ratio (NLR) \[59\] or either individual cells alone. 3.3. Statistical analysis Data were collected and excel tabulated in Microsoft Excel 2019. Statistical package for social studies software SPSS 26.0 (IBM, Armonk, NY) (https://www.ibm.com/products/spss-statistics), and GraphPad Prism® version 8.01 (GraphPad Software, San Diego, USA) (htt ps://www.graphpad.com/scientific-software/prism/) were utilized for figures, while MedCalc Statistical Software version 19.2.6 of (MedCalc Software by Ostend, Belgium) (https://www.medcalc.org) was used for the receiver operating characteristic (ROC) curve analysis. Data were tested for normality using Shapiro-Wilk normality test for both groups and subgroups data. Since the patients' data were not normally distributed, data were expressed as median (interquartile range: IQR (25th percentile-75th percentile). Mann-Whitney (U) or Kruskal-Wallis (H) were conducted to compare between any two or more independent groups, respectively. The ROC curve was used to find the best cutoff, sensitivities (SNs), specificities (SPs), negative predictive values (NPVs), and positive predictive values (PPVs), with an area under the curve (AUC) calculated ranged from 0 to 1. In medical testing, negative likelihood ratios (LRs) are used to understand the diagnostic or prognostic test utility. Essentially, the LR indicates the likelihood that a patient has a condition or disease. The likelihood that they have the disease or condition increases with the ratio. A low ratio, on the other hand, indicates that they most likely do not. Therefore, a physician can use these ratios to either rule in or rule out an illness. The ratio, which expresses how likely it is for someone to have the disease or condition, supports the SNs and SPs identified by the ROC curve. An alternative definition of the LR is SN and SP, where negative LR = (100 - SN)/SP. Spearman's correlation coefficient r was used to evaluate the correlation between various variables. Additionally, the expression levels of the lncRNA CCDC144NL-AS1, hsamiR- 143-3p, and HMGA2 protein were set to Spearman correlation r, and the link among two variables-one continuous and one dichotomous- was assessed using point-biserial correlation. Significance level was set if the two-tailed statistical analysis test p-value is \<0.05. ### Conditions Module **Conditions:** - Colorectal Cancer **Keywords:** - Colorectal cancer - lncRNA CCDC144NL-AS1 - Hsa-miR-143-3p - HMGA2 - Liquid biopsy - In silico analysis ### Design Module #### Bio Spec **Description:** Five milliliters of peripheral venous blood were withdrawn from controls and CRC patients, under strict sterile conditions, following standard international biosecurity safety procedures, into polymer gel clot activator vacutainers (Greiner Bio-One GmbH, Australia). At room temperature (25 ◦C), completely coagulated samples were centrifuged at 4000 rpm for 10 min. Sera obtained were aliquoted into three DNase/ RNase free Eppendorf tubes and stored at -80 ◦C for molecular analysis. **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 90 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A total of 60 primary CRC treatment-naïve Egyptian patients admitted to the Dar Al Shefa Hospital, Cairo, Egypt, were enrolled in the study. **Label:** Patient group #### Arm Group 2 **Description:** 30 age-matched and sex-matched apparently healthy volunteers, not receiving any medications or suffering from any disease, age range 30-60 years, were included as controls, male-to-female 1:1 (15/15). Control subjects were recruited randomly during routine check-up examinations for themselves or during blood donation. **Label:** Healthy Control ### Outcomes Module #### Primary Outcomes **Measure:** Expression pattern of ncRNAs in CRC patients and controls **Time Frame:** 9 months **Measure:** HMGA2 protein concentration in CRC patients and controls **Time Frame:** 12 months **Measure:** Association of the investigated ncRNAs and HMGA2 with clinicopathological features of CRC patients **Time Frame:** 12 months **Measure:** Correlation between lncRNA CCDC144NL-AS1, hsa-miR-143-3p and HMGA2 and the conventional CRC TMs **Time Frame:** 10 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * CRC diagnosed patients that is clinically confirmed by colonoscopy, abdominal radio-imaging, and histopathologicaly. Exclusion Criteria: * individuals receiving chemotherapy, radiation, or undergone surgery * patients with blood disorders * patients with any cancer other than CRC. * Individuals with inadequate data or missing histopathological diagnoses * distant metastases **Healthy Volunteers:** True **Maximum Age:** 60 Years **Minimum Age:** 30 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** Patients group A total of 60 primary CRC treatment-naïve Egyptian patients admitted to the Dar Al Shefa Hospital, Cairo, Egypt, were enrolled in the study. Control group 30 age-matched and sex-matched apparently healthy volunteers, not receiving any medications or suffering from any disease, age range 30-60 years, were included as controls, male-to-female 1:1 (15/15). Control subjects were recruited randomly during routine check-up examinations for themselves or during blood donation. ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Faculty of Pharmacy, Ain Shams University, Advanced Biochemistry Research Lab **Zip:** 11566 #### Overall Officials **Official 1:** **Affiliation:** Faculty of pharmacy Ain Shams University **Name:** Nadia Hamdy, PhD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Abd El Fattah YK, Abulsoud AI, AbdelHamid SG, AbdelHalim S, Hamdy NM. CCDC144NL-AS1/hsa-miR-143-3p/HMGA2 interaction: In-silico and clinically implicated in CRC progression, correlated to tumor stage and size in case-controlled study; step toward ncRNA precision. Int J Biol Macromol. 2023 Dec 31;253(Pt 2):126739. doi: 10.1016/j.ijbiomac.2023.126739. Epub 2023 Sep 9. **PMID:** 37690651 #### See Also Links **Label:** Related Info **URL:** https://pubmed.ncbi.nlm.nih.gov/37690651/ ## 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: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M20559 - Name: Disease Progression - Relevance: LOW - As Found: Unknown - 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: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System 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 ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M9662 - Name: Altretamine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427265 **Brief Title:** Machine Learning-based Longitudinal Study of Post-ICU Syndrome Development Trajectory in Critically Ill Patients and Construction of Clinical Early Warning Models: a Research Protocol for Longitudinal Study **Official Title:** Machine Learning-based Longitudinal Study of Post-ICU Syndrome Development Trajectory in Critically Ill Patients and Construction of Clinical Early Warning Models: a Research Protocol for Longitudinal Study #### Organization Study ID Info **ID:** ZHKYQ202316 #### Organization **Class:** OTHER **Full Name:** The Affiliated Hospital Of Guizhou Medical University ### Status Module #### Completion Date **Date:** 2026-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-12-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Chinese nursing association **Class:** UNKNOWN **Name:** Affiliated Hospital of Guizhou Medical University #### Lead Sponsor **Class:** OTHER **Name:** The Affiliated Hospital Of Guizhou Medical 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:** This project intends to track and evaluate whether post-ICU syndrome will occur 7 days, 1 month, 3 months and 6 months after ICU patients are transferred out of the ICU through a longitudinal study, apply the latent category growth model to identify different trajectory patterns of post-ICU syndrome in critically ill patients, and use modern machine learning models to build an early warning model of the trajectory patterns of post-ICU syndrome. ### Conditions Module **Conditions:** - Developmental Trajectory of Patients With Post-ICU Syndrome - Development and Application of Post-ICU Syndrome Prediction Model **Keywords:** - Post-icu syndrome - Prediction model - Development Trajectory ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 840 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Intensive Care Unit Memory Tool score\\Richards-Campbell Sleep Questionnaire score **Measure:** Correlation scale score **Time Frame:** 2024.01-2026.06 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Length of stay in ICU ≥24h; ②Age ≥18 years old; ③ Conscious when leaving ICU, communicating with investigators without barriers; ④ Informed consent. Exclusion Criteria: * ① had been admitted to ICU for more than 24h within 3 months prior to this admission; ② Transferred to another ICU; ③ There was cognitive impairment before ICU admission (BDRS \> 4); (4) Serious hearing impairment, dysarthria, etc., can not be followed up; ⑤ Serious illness can not cooperate to complete the questionnaire. **Healthy Volunteers:** True **Maximum Age:** 100 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The inclusion criteria of family members were as follows: 1 family member of each patient aged ≥18 years was selected; (2) Assume the main role of caring for patients and medical decision-making; ③ no history of mental illness or other serious organic diseases; ④ Informed consent, voluntary participation in this study. Exclusion criteria for family members: ① Family members refused to participate in the study due to their own reasons; ② Severe hearing and language impairment could not cooperate with the researchers. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Tingrui WANG **Phone:** 19117899885 **Role:** CONTACT #### Locations **Location 1:** **City:** GuiYang **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Tingrui WANG - **Phone:** 19117899885 - **Role:** CONTACT **Country:** China **Facility:** Affiliated Hospital of Guizhou Medical University **State:** Guizhou **Status:** RECRUITING **Zip:** 550004 #### Overall Officials **Official 1:** **Affiliation:** Affiliated Hospital of Guizhou Medical University **Name:** Li Yao **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - 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: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M19010 - Name: Critical Illness - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013577 - Term: Syndrome ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427252 **Brief Title:** The Efficacy and Safety of HIPEC Combined With PD-1 and SOX Chemotherapy for the Translational Treatment of GC or EGJC With PM **Official Title:** The Efficacy and Safety of HIPEC Combined With PD-1 and SOX Chemotherapy for the Translational Treatment of Gastric or Esophagogastric Junctional Cancer With Peritoneal Metastasis: A Prospective, Multicenter Phase II Study #### Organization Study ID Info **ID:** GHIST24 #### Organization **Class:** OTHER **Full Name:** The First Affiliated Hospital with Nanjing Medical University ### Status Module #### Completion Date **Date:** 2026-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-31 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The First Affiliated Hospital with Nanjing Medical University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False ### Description Module **Brief Summary:** Gastric cancer (GC) with peritoneal metastasis has a poor prognosis and short survival. In recent years, heat intraperitoneal perfusion chemotherapy (HIPEC) has gained better efficacy in the treatment of peritoneal metastases of many malignant tumors, including GC with peritoneal metastasis. The use of immune checkpoint inhibitors (ICIs) in the treatment of advanced GC has made significant progress in recent years. And studies showed that patients who were responded to immunotherapy combined with chemotherapy as the first-line treatment were able to achieve significant survival benefit after radical resection. However, whether HIPEC combined with immunotherapy for peritoneal metastatic gastric cancer improves the R0 resection rate and prolongs survival time is currently unclear. Therefore, we conducted this prospective multicenter clinical trial to explore the effective dose and safety of the combination of systemic chemotherapy, HIPEC, anti-PD-1 and anti-HER-2 therapy, which will provide a clinical basis for the treatment of advanced GC. **Detailed Description:** Gastric cancer (GC) is the 5th most common malignant tumor worldwide, and it causes the 4th most tumor-related deaths among all malignant tumors. China is a large country with 40% of the total number of GC cases worldwide. Despite the advances in medical detection methods, most of the GC patients in China are in the advanced stage at the time of diagnosis, in which peritoneal metastasis is one of the common metastatic patterns of advanced GC, and the presence of peritoneal metastasis accounts for about 46% of patients with distant metastasis detected at the first diagnosis. The prognosis of GC patients with peritoneal metastasis is extremely poor, and compared with other metastatic organs, patients with stage IV GC with peritoneal metastasis have a worse prognosis and shorter survival. The treatment of peritoneal metastasis of GC has been based on systemic chemotherapy with reference to advanced GC, but it is difficult for traditional chemotherapeutic agents to reach the peritoneal lesions due to the existence of blood-peritoneal barrier. In recent years, heat intraperitoneal perfusion chemotherapy (HIPEC) has gained better efficacy in the treatment of peritoneal metastases of many malignant tumors, including GC.HIPEC allows chemotherapeutic drugs to act directly on tumor tissues while reducing the impact on other parts of the body; the warming effect is synergistic with the antitumor effects of chemotherapeutic drugs and helps the drugs to act more efficiently on the intraperitoneal tumor cells; moreover, the chemotherapeutic drugs are absorbed through the peritoneum and then enter the liver via the portal vein route, which is beneficial to preventing liver metastasis. HIPEC currently has four applications and indications in the clinic: firstly, palliative application to improve the quality of life for GC abdominal metastasis with a large amount of carcinomatous ascites; secondly, therapeutic application of radical gastric cancer surgery + cytoreductive surgery + HIPEC for the treatment of GC; third, prophylactic application, radical gastric cancer surgery + peritoneal hyperthermia chemotherapy, targeting people with high risk of peritoneal recurrence, especially patients with T3-4 or positive lymph nodes; fourth, neoadjuvant application, neoadjuvant chemotherapy combined with peritoneal hyperthermia chemotherapy before radical gastric cancer treatment, in order to reduce the risk of peritoneal implantation of gastric cancer and to increase the possibility of radical surgery. However, there is a lack of high-level evidence-based medical evidence on the efficacy and safety of HIPEC as a translational treatment for GC with peritoneal metastasis. The use of immune checkpoint inhibitors (ICIs) in the treatment of advanced GC has made significant progress in recent years. The KEYNOTE series of studies evaluated the safety and efficacy of PD-L1 antibody as a first-line treatment for advanced GC, among which the results of KEYNOTE-859 confirmed that the combination of Pembrolizumab and chemotherapy is expected to be a HER-2 negative advanced gastric/esophagogastric junctional cancer first-line treatment option. A recent retrospective study by Chinese scholars demonstrated that patients with stage IV GC who were responded to the immunotherapy combined with chemotherapy as the first-line treatment were able to achieve significant survival benefit after radical resection. However, whether HIPEC combined with immunotherapy for peritoneal metastatic gastric cancer improves the R0 resection rate and prolongs survival time is currently unclear. Therefore, we conducted this prospective multicenter clinical trial trying to combine the specificity of HIPEC for peritoneal metastases with immunotherapy for advanced GC, aiming to evaluate the efficacy and feasibility of multimodal treatment regimens, such as HIPEC in combination with immunotherapy, for the transformative treatment of peritoneal metastases of GC or EJ junctional cancer and to explore the effective dose and safety of the combination of systemic chemotherapy, HIPEC, anti-PD-1 and anti-HER-2 therapy, which will provide a clinical basis for the treatment of advanced GC. ### Conditions Module **Conditions:** - Gastric Cancer, Metastatic **Keywords:** - gastric cancer - peritoneal metastasis - HIPEC - immunotherapy ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** HIPEC treatment (paclitaxel, at 43°C for 60 min) was performed on the 1st day after the first exploratory laparotomy and on the third day after the radical surgery for a total of 2-3 times (total amount of paclitaxel was 175 mg/m2 ). Systemic therapy was started 3 weeks after HIPEC. Systemic therapy including: Tirilizumab: 200 mg, Q3W; oxaliplatin: 130mg/m2, Q3W; Herceptin: loading dose of 8 mg/kg followed by 6 mg/kg Q3W. Tegeo: Oral administration: 40 mg per dose for BSA \<1.25, 50 mg per dose for BSA 1.25 to 1.5, and 60 mg per dose for BSA ≥1.5, twice daily for each treatment cycle Q3W; After 2-6 weeks, laparoscopic exploration was performed, PCI score was calculated, and radical surgery was performed in patients who were eligible for radical surgery. Postoperative HIPEC was performed twice. **Intervention Names:** - Drug: HIPEC - Drug: Systemic therapy **Label:** HIPEC plus PD-1 plus SOX therapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - HIPEC plus PD-1 plus SOX therapy **Description:** In the experimental group, HIPEC treatment (paclitaxel, 3000 ml of physiological saline at 43°C for 60 min) was performed on the first day after the first exploratory laparotomy and on the third day after the radical surgery for a total of 2-3 times (total amount of paclitaxel was 175 mg/m2 ), with an interval of not more than 72 h. Intravenous systemic therapy was started 3 weeks after the completion of HIPEC treatment. systemic therapy. **Name:** HIPEC **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - HIPEC plus PD-1 plus SOX therapy **Description:** 1. Tirilizumab: 200 mg, i.v., D1, Q3W; 2. oxaliplatin: 130mg/m2, i.v., D1, Q3W; 3. Herceptin: a tri-weekly dosing regimen with an initial loading dose of 8 mg/kg followed by 6 mg/kg Q3W. 4. Tegeo: Oral administration: 40 mg per dose for BSA \<1.25, 50 mg per dose for BSA 1.25 to 1.5, and 60 mg per dose for BSA ≥1.5, twice daily for each treatment cycle D1-D14, Q3W; **Name:** Systemic therapy **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The proportion of patients still alive at one year from the start of patient enrollment was calculated as a percentage of all patients. Deaths from all causes were included in the calculation of overall survival. The OS of patients who did not reach the one-year loss to follow-up was counted as data censored at the time of last confirmed survival before the loss to follow-up, i.e., only the time point of last known survival was counted in the number of survivors. **Measure:** Overall Survival **Time Frame:** 1 year #### Secondary Outcomes **Description:** Percentage of all patients who did not experience disease progression or death within one year from the start of patient enrollment. If disease progression is indicated by imaging, the date of disease progression will be the time of the imaging exam that clearly confirms disease progression. If disease progression was diagnosed by other clinical modalities, the date of diagnosis will be used as the date of disease progression. Patients who discontinued the trial (without follow-up imaging) for reasons other than disease progression and patients who received post-trial therapy will have the time of discontinuation of the trial or the time of initiation of post-trial therapy as the data censored. New onset of other tumors is not considered a disease progression event and is also not censored as data. **Measure:** Progression-free Survival **Time Frame:** 1 year **Description:** CC-0 indicates no residual tumor visible to the naked eye, CC-1 indicates residual tumor with a maximum diameter of \<2.5 mm, CC-2 indicates residual tumor with a diameter of more than 2.5 mm but \<25 mm, and CC-3 indicates residual tumor with a diameter of ≥25 mm. CC-0 and CC-1 are usually classified as complete cytoreduction. **Measure:** Completeness of cytoreduction score **Time Frame:** 1 year **Description:** Refers to the proportion of patients whose tumors shrank to a certain level and remained there for a certain period of time, and includes both CR (Complete Response) and PR (Partial Response) cases. Objective tumor remission was assessed using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). Patients had to be accompanied by measurable tumor lesions at baseline, and the efficacy assessment criteria were classified as Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressed Disease (PD) according to the RECIST 1.1 criteria. Disease (PD). **Measure:** Objective Response Rate **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. patients with a pathologically confirmed primary diagnosis of gastric/esophagogastric junctional cancer who have not undergone chemotherapy, radiotherapy, or other antitumor therapy prior to the start of the clinical trial; 2. age 18 to 75 years Eastern Coorperative Oncology Group (ECOG): 0 to 1 points; 3. diagnosis of metastatic adenocarcinoma of the peritoneum \[peritoneal cancer index (PCI) ≤ 20 points\] with or without ascites (beyond the pelvis but not reaching full abdominal ascites) by laparoscopic exploration; 4. Voluntarily sign the informed consent form. 5. good cardiac function for resection with curative intent. If clinically indicated, patients with underlying ischemic, valvular heart disease or other severe heart disease should be evaluated preoperatively by a cardiologist; 6. normal function of major organs and subjects are required to meet the following laboratory criteria: 1) Absolute neutrophil count (ANC) ≥ 1.5x109/L in the last 14 days without granulocyte colony-stimulating factor (GCSF); 2) Platelets ≥ 100 x 109/L in the absence of blood transfusion in the last 14 days; 3) Hemoglobin \> 9 g/dL without transfusion or erythropoietin use in the last 14 days; 4) Total bilirubin ≤ 1.5 x upper limit of normal (ULN); enrollment is also allowed if total bilirubin \> 1.5 x ULN but direct bilirubin ≤ ULN; 5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN. 6) Blood creatinine ≤1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 ml/min; 7) good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 x ULN; 8) Normal thyroid function, defined as thyrotropin (TSH) within the normal range. If baseline TSH is outside the normal range, subjects may also be enrolled if total T3 (or FT3) and FT4 are within the normal range; 9) Cardiac enzyme profiles within the normal range (enrollment will be allowed if the investigator determines that the laboratory abnormality is not of clinical significance); 7) Thyroid function: thyroid stimulating hormone (TSH) and free thyroxine (FT3/FT4) in the normal range or mildly abnormal without clinical significance; 8. weight of 40 kg or more (including 40 kg), or BMI \> 18.5; 9. female patients must meet: * Menopausal (defined as absence of menstruation for at least 1 year with no confirmed cause other than menopause) status, or surgically sterilized (removal of ovaries and/or uterus), or patients of childbearing potential must also meet the following requirements: * Pregnancy test within 7 days prior to first dose must be negative; * Agree to use contraception with an annual failure rate of \< 1% or remain abstinent (avoid heterosexual intercourse) (at least 120 days from signing the informed consent form until at least 9 months after the last dose of the test drug and at least 9 months after the procedure (contraceptive methods with an annual failure rate of \< 1% include bilateral tubal ligation, male sterilization, proper use of hormonal contraceptives that suppress ovulation, hormone-releasing intrauterine contraceptives, and copper-containing intrauterine devices). .; * No breastfeeding is allowed. 10. The subject reads and fully understands the patient instructions and signs the informed consent form. Exclusion Criteria: 1. the patient has a previous (within 5 years) or concurrent other malignant tumor; 2. patients who are preparing for or have previously received organ or bone marrow transplantation; 3. have had a blood transfusion within 2 weeks prior to the first dose, or have a history of bleeding, and any bleeding event with a severity rating of 3 or more on the CTCAE 4.0 within 4 weeks prior to screening; 4. abnormal coagulation with bleeding tendency (INR in the absence of anticoagulants at normal values \> 1.5); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; the use of low-dose warfarin (1 mg orally once daily) for prophylactic purposes is permitted, provided the International Normalized Ratio of the prothrombinogen time (INR) is ≤ 1.5, or Small-dose aspirin (no more than 100 mg daily); 5. an actinic/venous thrombotic event within 6 months prior to screening, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (except for venous thrombosis due to intravenous cannulation for pre-chemotherapy, which has resolved in the judgment of the investigator), and pulmonary embolism; 6. myocardial infarction, poorly controlled arrhythmia (including QTc interval ≥ 450 ms in men and ≥ 470 ms in women) within 6 months prior to the first dose (QTc interval is calculated using the Fridericia formula); 7. the presence of NYHA class III-IV cardiac insufficiency or cardiac ultrasound: LVEF (left ventricular ejection fraction) \<50%; 8. urine protein ≥++ and confirmed 24-hour urine protein quantification \>1.0 g; 9. have multiple factors that interfere with oral administration of medications (e.g., inability to swallow, chronic diarrhea, and intestinal obstruction) 10. pleural effusion with clinical symptoms requiring clinical intervention; 11. human immunodeficiency virus (HIV) infection; 12. active tuberculosis; 13. long-standing unhealed wounds or incompletely healed fractures; 14. patients with pre-existing and current interstitial pneumonitis, pneumoconiosis, radiation pneumonitis, drug-associated pneumonitis, and severely impaired lung function that may interfere with the detection and management of suspected drug-associated pulmonary toxicity 15. the presence of a known active or suspected autoimmune disease, except those who are in a stable state of that disease at the time of enrollment (not requiring systemic immunosuppressive therapy); 16. a history of severe chronic autoimmune disease, such as systemic lupus erythematosus; a history of inflammatory bowel disease, such as ulcerative enteritis, Crohn's disease, or chronic diarrheal disease, such as irritable bowel syndrome; a history of tuberculosis or tuberculosis; a history of active hepatitis B, hepatitis C, or HIV; or well-controlled non-severe immune disorders, such as dermatitis, arthritis, or psoriasis, may be eligible. .. Hepatitis B virus titers \< 500copy/ml may be enrolled; 17. patients requiring treatment with systemic corticosteroids (\> 10 mg/day prednisone efficacy dose) or other immunosuppressive drugs within 14 days prior to the first dose or during the study period. However, enrollment is permitted if patients are allowed to use topical topical or inhaled steroids, or adrenal hormone replacement therapy at doses ≤ 10 mg/day prednisone efficacy dose in the absence of active autoimmune disease; 18. any active infection requiring systemic administration of anti-infective therapy within 14 days prior to the first dose; except for prophylactic antibiotic therapy (e.g., for the prevention of urinary tract infections or chronic obstructive pulmonary disease); 19. treatment with a live vaccine within 28 days prior to the first dose; except inactivated viral vaccines for seasonal influenza; 20. prior treatment with antibodies/drugs targeting immune checkpoints, e.g., PD-1, PD-L1, CTLA-4 inhibitors, etc; 21. have received treatment with immunologically-affecting related drugs or medical technologies (including but not limited to the following: thymopentin, thymofacine, interferon, CAR-T therapy, etc.) within 6 months prior to the first dose of the drug 22. is receiving treatment in another clinical study or is scheduled to begin treatment in this study less than 1 month from the end of treatment in the previous clinical study; 23. has a known history of allergy or intolerance to any study medication or its components 24. patients with a history of alcoholism, drug abuse, and substance abuse. Patients who have stopped drinking alcohol may be enrolled; 25. patients with non-compliance with medical advice, non-adherence to prescribed medication, or incomplete information that may affect the judgment of efficacy or safety; 26. pregnant or lactating female patients; 27. patients with conditions that may increase the risk of study participation and study medication, or other severe, acute, and chronic conditions that, in the judgment of the investigator, make participation in a clinical study unsuitable. 28. other conditions that, in the judgment of the investigator, make them unsuitable for this clinical trial. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Fengyuan Li, PhD **Phone:** +8617366065271 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Yigang Zhang, PhD **Phone:** +8615996341965 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** The First Affiliated Hospital with Nanjing Medical University **Name:** Zekuan Xu, PhD **Role:** STUDY_CHAIR ## 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: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16064 - Name: Stomach Neoplasms - Relevance: HIGH - As Found: Gastric Cancer - ID: M12307 - Name: Neoplasm Metastasis - 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: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M16062 - Name: Stomach Diseases - Relevance: LOW - As Found: Unknown - ID: T5486 - Name: Stomach Cancer - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013274 - Term: Stomach Neoplasms ### 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: LOW - As Found: Unknown - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M1674 - Name: Oxaliplatin - Relevance: LOW - As Found: Unknown - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427239 **Brief Title:** Exploratory Clinical Study of HRS-4642 Combined With Adebelimab in the Treatment of Advanced Pancreatic Cancer **Official Title:** A Single-center, Open-label, Exploratory Study of HRS-4642 Combined With Adebelimab in the Treatment of Advanced Pancreatic Cancer #### Organization Study ID Info **ID:** PANC-2nd-IIT-HRS4642-SHR1316 #### Organization **Class:** OTHER **Full Name:** Fudan University ### Status Module #### Completion Date **Date:** 2026-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Jiangsu HengRui Medicine Co., Ltd. #### Lead Sponsor **Class:** OTHER **Name:** Fudan University #### Responsible Party **Investigator Affiliation:** Fudan University **Investigator Full Name:** Xian-Jun Yu **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 study is being conducted to evaluate the safety, tolerability and efficacy of HRS-4642 combined with adebelimab in subjects with locally advanced or metastatic pancreatic ductal adenocarcinoma. **Detailed Description:** This study is an open, single center, exploratory clinical trial aimed at evaluating the efficacy and safety of HRS-4642 combined with adebelimab in the treatment of patients with unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma. This study experiment is divided into two stages: dose exploration stage and efficacy exploration stage. During the dose exploration phase, RP2D was determined based on the safety, tolerability, and preliminary efficacy data of HRS-4642 combined with adelbizumab treatment, and then entered the efficacy exploration phase. ### Conditions Module **Conditions:** - Pancreatic Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 35 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** For HRS-4642 in combination with Adebrelimab, for advanced or metastatic pancreatic ductal adenocarcinoma. **Intervention Names:** - Drug: HRS-4642 - Drug: Adebrelimab **Label:** Part A: Dose Escalation; Part B: Dose Expansion **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Part A: Dose Escalation; Part B: Dose Expansion **Description:** HRS-4642 will be administrated per dose level in which the patients are assigned. **Name:** HRS-4642 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Part A: Dose Escalation; Part B: Dose Expansion **Description:** Adebrelimab will be administrated per dose level in which the patients are assigned **Name:** Adebrelimab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** A DLT is defined as any event meeting the DLT criteria occurring within 21 days of first dose on Cycle 1 Day 1 (C1D1), excluding toxicities clearly related to disease progression or intercurrent illness **Measure:** Dose Limited Toxicity (DLT) **Time Frame:** Day 1 to Day 21 after the first combination therapy was administrated **Description:** RP2D will be determined on the basis of evaluation on safety and efficacy data in dose escalation stages. **Measure:** Recommended phase II dose (RP2D) **Time Frame:** Approximately 12 months **Description:** Evaluated by RECIST v1.1. **Measure:** Objective Response Rate (ORR) **Time Frame:** Up to approximately 12 months #### Secondary Outcomes **Description:** Evaluated by RECIST v1.1. **Measure:** Disease Control Rate (DCR) **Time Frame:** Up to approximately 12 months **Description:** Evaluated by RECIST v1.1. **Measure:** Duration of Response (DOR) **Time Frame:** Up to approximately 12 months **Description:** Time from the date of enrollment to of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free. **Measure:** Progression Free Survival (PFS) **Time Frame:** Up to approximately 12 months **Description:** Time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive. **Measure:** Overall survival (OS) **Time Frame:** Up to approximately 12 months **Description:** AEs are assessed by NCI-CTCAE v5.0 **Measure:** Adverse events (AEs) **Time Frame:** From the first drug administration to within 90 days for the last adebrelimab dose ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients volunteered to participate in this study and signed informed consent; 2. Age: ≥18 and ≤75 years old, male or female; 3. Advanced (metastatic or unresectable) Pancreatic ductal adenocarcinoma; and subjects must have at least one measurable lesion as defined by RECIST v1.1; 4. With failure or absence of standard treatment, and progress within 6 months of adjuvant therapy can also be included in the study; 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; 6. Life expectancy ≥ 12 weeks; 7. Adequate marrow and organ function; 8. AE caused by previous anti-tumor therapy must be restored to ≤ level 1 (CTCAE v5.0) or a stable state evaluated by the researcher, except for hair loss (any level) and peripheral neuropathy of level 2; 9. Female participants of childbearing age must undergo a pregnancy test within one week before the start of the study medication, and the result is negative. They are willing to use a medically recognized and efficient contraceptive method during the study period and within three months after the last administration of the study medication; For male participants whose partners are women of childbearing age, they should agree to use effective methods of contraception during the study period and within 3 months after the last study administration; Exclusion Criteria: 1. Known to be allergic to the investigational drug or any of its components; 2. Have other active malignancies within 5 years; 3. Systemic antitumor therapy was received 4 weeks before the start of the study, and palliative radiotherapy was completed within 14 days before the first dose; 4. Previously received allogeneic hematopoietic stem cell transplantation or organ transplantation; 5. Accompanied by untreated or active central nervous system (CNS) metastases; 6. Within 6 months prior to entering the study, patients with severe cardiovascular and cerebrovascular thromboembolism; 7. Hypertension with poor drug control (continuous increase in systolic blood pressure ≥ 150mm Hg or diastolic blood pressure ≥ 100mmHg); 8. Late stage patients with symptoms that have spread to the internal organs and are at risk of life-threatening complications in the short term; 9. With interstitial lung disease, non-infectious pneumonia, severe and uncontrolled internal medicine diseases, acute infections, recent history of major surgery (within 28 days or not yet recovered from side effects); 10. Participated in clinical trials of any drug or medical device within 4 weeks prior to the first administration; 11. With congenital or acquired immune deficiency, such as people infected with HIV, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the detection limit of the analytical method) or combined with hepatitis B and hepatitis C infection; 12. With any active autoimmune diseases or a history of autoimmune diseases; 13. Received systemic treatment with corticosteroids or other immunosuppressants within 2 weeks prior to the first medication; 14. High risk of pancreatitis, serum amylase and/or lipase concentrations ≥ 3 times ULN; who have a simple increase in lipase, will be considered for inclusion by the researchers; 15. Other situations that researchers believe should not be included. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Shanghai **Country:** China **Facility:** Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University **State:** Shanghai **Zip:** 200032 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000004066 - Term: Digestive System Diseases - 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: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13110 - Name: Pancreatic Neoplasms - Relevance: HIGH - As Found: Pancreatic Cancer - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - 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: T4387 - Name: Pancreatic Cancer - Relevance: HIGH - As Found: Pancreatic Cancer ### Condition Browse Module - Meshes - ID: D000010190 - Term: Pancreatic Neoplasms ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427226 **Brief Title:** Evaluation of the Possible Safety and Efficacy of Dapagliflozin in the Prophylaxis of Doxorubicin-Induced Cardiotoxicity **Official Title:** Clinical Study to Evaluate the Possible Safety and Efficacy of Dapagliflozin in the Prophylaxis of Doxorubicin-Induced Cardiotoxicity in Breast Cancer Patients #### Organization Study ID Info **ID:** Dapagliflozin in breast cancer #### Organization **Class:** OTHER **Full Name:** Tanta University ### Status Module #### Completion Date **Date:** 2025-08-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-18 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-18 **Study First Submit QC Date:** 2024-05-18 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Tanta University #### Responsible Party **Investigator Affiliation:** Tanta University **Investigator Full Name:** Sandy Ehab Nabil Rezkallah **Investigator Title:** Clinical Pharmacist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is a randomized controlled clinical trial that aims to evaluate the safety and efficacy of Dapagliflozin as a cardioprotective in doxorubicin-induced cardiotoxicity in breast cancer patients. **Detailed Description:** Breast cancer is the most common type of cancer in women and the first cause of cancer death among them. In Egypt, it represents 33%of female cancer cases and more than 22,000 new cases are diagnosed each year. This is expected to rise exponentially over the next years given the enlarging population and changes in the population pyramid. The Early Breast Cancer "Trialists" Collaborative Group (EBCTCG) reported that the inclusion of anthracyclines as doxorubicin in the management of breast cancer improved absolute survival by approximately 3% at 5 years and 4% at 10 years. Therefore, anthracyclines remain the cornerstone of treatment for breast cancer patients. Despite its effectiveness, doxorubicin is associated with cumulative, dose-dependent, and potential cardiotoxicity. Although the main mechanism of doxorubicin-induced cardiotoxicity has not been fully known, there are several mechanisms proposed for cardiac injury including oxidative stress, free radical generation, and apoptosis are most widely reported. Other mechanisms are also involved such as impaired mitochondrial function, perturbation in iron regulatory protein, disruption of Ca2+ homeostasis, autophagy, and the release of nitric oxide and inflammatory mediators. Dapagliflozin (DAPA), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, is a class of glucose-lowering agents and is used to treat patients with type 2 diabetes. Besides reducing glucose reabsorption, DAPA has shown protective effects on cardiovascular diseases. The cardioprotective effects of DAPA have been demonstrated in patients with diabetic cardiomyopathy, heart failure (HF) with preserved ejection fraction (EF), and HF with reduced EF. SGLT2 inhibitors exert their cardioprotective effect by increasing energy metabolism, mitochondrial biogenesis, autophagy, and ketone bodies while decreasing endoplasmic reticulum (ER) stress, ferroptosis, oxidative stress, and inflammation. In a recent animal study, DAPA protected against doxorubicin-induced cardiotoxicity by reducing ER stress, as evidenced by the decreased expression of the ER-related proteins including glucose-regulated protein 78, protein kinase R-like endoplasmic reticulum kinase and transcription factor 4. Doxorubicin administration have been shown to increase HF incidence, HF admissions, and the development of cardiomyopathy which is defined by a decline in left ventricle ejection fraction and these outcomes were attenuated by SGLT2 inhibitors. It is known that doxorubicin increases the circulating level of N-terminal pro-B-type natriuretic peptide (NT-pro-BNP) and cardiac Troponin T (cTnT) which DAPA significantly reduced in a recent animal study. ### Conditions Module **Conditions:** - Doxorubicin Induced Cardiomyopathy - Breast Cancer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 46 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 23 breast cancer patients which will receive four cycles of AC regimen (Doxorubicin and Cyclophosamide; each cycle is given every 21 days) only. **Label:** Control Group **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** 23 breast cancer patients which will receive four cycles of AC regimen (Doxorubicin and Cyclophosamide; each cycle is given every 21 days) plus Dapagliflozin 10 mg once daily. **Intervention Names:** - Drug: Dapagliflozin 10mg Tab **Label:** Dapagliflozin group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Dapagliflozin group **Description:** Dapagliflozin 10 mg tab once daily given during the duration of AC cycles. **Name:** Dapagliflozin 10mg Tab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Initial evaluation of cardiac function by Echocardiography at baseline and after the end of chemotherapy. The primary outcome is to avoid reduction in patients' ejection fraction during doxorubicin administration. **Measure:** Assessment of changes in ejection fraction using echocardiography **Time Frame:** Baseline and after the last AC cycle of chemotherapy (3months). #### Secondary Outcomes **Description:** Monitoring the serum biomarker Cardiac Troponin T at baseline and after the end of chemotherapy. **Measure:** Change in Cardiac Troponin T level **Time Frame:** Baseline and after the last AC cycle of chemotherapy (3months). **Description:** Monitoring the serum biomarker NT-pro-BNP at baseline and after the end of chemotherapy. **Measure:** Change in N-terminal pro-B-type natriuretic peptide level **Time Frame:** Baseline and after the last AC cycle of chemotherapy (3months). ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥18 years old. * Chemo-naïve patients with biopsy confirmed diagnosis of breast cancer and with stage I-III breast cancer according to the American Joint Committee on Cancer (TNM staging system of breast cancer). * Patients intended to receive at least 4 cycles of doxorubicin or more. * Patients with performance status \<2 according to Eastern Cooperative Oncology Group (ECOG) score. * Echocardiographic LVEF ≥55%. * Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5 ×109/L, platelet count ≥ 90 × 109/L and hemoglobin level ≥ 10 g/dl). * Patients with adequate liver function and adequate renal function. * Signed informed consent to participate in the study. Exclusion Criteria: * Age \<18 years old and \>65 years old. * Patients with prior exposure to anthracyclines within the last 6 months. * Patients with evidence of metastasis at initial assessment. * Treatment with any SGLT-2 inhibitors for 6 months prior to the screening. * Patients taking any other cardioprotective medications. * Pregnancy and breast feeding. * Alcohol abuse. * History of heart failure or LVEF \<50%. * Presence of any cardiac-related conditions such as angina pectoris, valvular disease, uncontrolled systemic hypertension, coronary heart disease, and cardiac surgery within the last 3 months. * Patients with type 1 diabetes mellitus or diabetic ketoacidosis, history of stroke, and patients with severe renal impairment with GFR \<25ml/min/1.73m2 . - Patients taking gatifloxacin as it causes major drug interaction with dapagliflozin. **Gender Based:** True **Gender Description:** Female breast cancer patients **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Sandy Rezkallah, Bachelor **Phone:** 01221065882 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Osama M Ibrahim, Professor **Role:** CONTACT #### Locations **Location 1:** **City:** Alexandria **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Sandy E Rezkallah, Bachelor - **Phone:** 01221065882 - **Role:** CONTACT ***Contact 2:*** - **Name:** Heba Elsheredy, Professor - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Egypt **Facility:** Medical Research Institute **State:** Bab Sharqi **Zip:** 21526 #### Overall Officials **Official 1:** **Affiliation:** faculty of pharmacy Tanta University **Name:** Sandy E Rezkallah, bachelor **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Belen E, Canbolat IP, Yigitturk G, Cetinarslan O, Akdeniz CS, Karaca M, Sonmez M, Erbas O. Cardio-protective effect of dapagliflozin against doxorubicin induced cardiomyopathy in rats. Eur Rev Med Pharmacol Sci. 2022 Jun;26(12):4403-4408. doi: 10.26355/eurrev_202206_29079. **PMID:** 35776041 **Citation:** Avula V, Sharma G, Kosiborod MN, Vaduganathan M, Neilan TG, Lopez T, Dent S, Baldassarre L, Scherrer-Crosbie M, Barac A, Liu J, Deswal A, Khadke S, Yang EH, Ky B, Lenihan D, Nohria A, Dani SS, Ganatra S. SGLT2 Inhibitor Use and Risk of Clinical Events in Patients With Cancer Therapy-Related Cardiac Dysfunction. JACC Heart Fail. 2024 Jan;12(1):67-78. doi: 10.1016/j.jchf.2023.08.026. Epub 2023 Oct 25. **PMID:** 37897456 **Citation:** Chang WT, Lin YW, Ho CH, Chen ZC, Liu PY, Shih JY. Dapagliflozin suppresses ER stress and protects doxorubicin-induced cardiotoxicity in breast cancer patients. Arch Toxicol. 2021 Feb;95(2):659-671. doi: 10.1007/s00204-020-02951-8. Epub 2020 Nov 19. **PMID:** 33211168 ## 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: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010335 - Term: Pathologic Processes - ID: D000064420 - Term: Drug-Related Side Effects and Adverse Reactions - ID: D000064419 - Term: Chemically-Induced Disorders - ID: D000011832 - Term: Radiation Injuries - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC25 - Name: Substance Related Disorders - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M12154 - Name: Cardiomyopathies - Relevance: HIGH - As Found: Cardiomyopathy - ID: M30670 - Name: Cardiotoxicity - Relevance: HIGH - As Found: Cardiotoxicity - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M30303 - Name: Drug-Related Side Effects and Adverse Reactions - Relevance: LOW - As Found: Unknown - ID: M30302 - Name: Chemically-Induced Disorders - Relevance: LOW - As Found: Unknown - ID: M14679 - Name: Radiation Injuries - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: T1930 - Name: Doxorubicin Induced Cardiomyopathy - Relevance: HIGH - As Found: Doxorubicin Induced Cardiomyopathy ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms - ID: D000009202 - Term: Cardiomyopathies - ID: D000066126 - Term: Cardiotoxicity ### Intervention Browse Module - Ancestors - ID: D000077203 - Term: Sodium-Glucose Transporter 2 Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents ### Intervention Browse Module - Browse Leaves - ID: M348449 - Name: Dapagliflozin - Relevance: HIGH - As Found: 0.9 - ID: M7492 - Name: Doxorubicin - Relevance: LOW - As Found: Unknown - ID: M227339 - Name: Liposomal doxorubicin - Relevance: LOW - As Found: Unknown - ID: M1691 - Name: Sodium-Glucose Transporter 2 Inhibitors - Relevance: LOW - As Found: Unknown - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000529054 - Term: Dapagliflozin ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427213 **Brief Title:** This is a Phase II, Open-label, Multicentre Study of Zanubrutinib-containing Regimens in Patients With Newly Diagnosed Mantle Cell Lymphoma **Official Title:** A Study of the Zanubrutinib-containing Regimens in Patients With Newly Diagnosed Mantle Cell Lymphoma #### Organization Study ID Info **ID:** IIT-TN MCL #### Organization **Class:** OTHER_GOV **Full Name:** Henan Cancer Hospital ### Status Module #### Completion Date **Date:** 2029-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-12-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Henan Cancer Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is a phase II, open-label, multicentre study of Zanubrutinib-containing regimens in patients with newly diagnosed mantle cell lymphoma. **Detailed Description:** This study is a prospective, multicenter, investigator-initiated clinical trial to evaluate the efficacy and safety of zanubrutinib-containing regimens in the treatment of newly diagnosed elderly or young patients with high risk MCL, aiming to find a more optimal treatment regimen for elderly or young patients with high risk MCL to improve the efficacy, survival time and quality of life of patients. In elderly patients arm：patients start with the induction therapy of zanubrutinib combined with obinutuzumab for 1 year and then entered the maintenance therapy of zanubrutinib orally until intolerable toxicity or disease progression In young patients with high risk arm：patiens \<65 years，and meet one or more of the following risk factors: TP53 mutation, blastoid/pleomorphic type, high sMIPI score. patients start with 6 cycles of induction therapy with zanubrutinib combined with R-BAC regimen, and the patients who achieve CR/PR and meet the transplantation criteria will receive ASCT consolidationand, then received maintenance therapy with zanubrutinib. otherwise, Patients who is ineligible for transplantation，will take zanubrutinib orally until intolerable toxicity or disease progression. ### Conditions Module **Conditions:** - Lymphoma, Mantle-Cell - Lymphoma, Non-Hodgkin **Keywords:** - Zanubrutinib ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 41 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Induction: Zanubrutinib and Obinutuzumab 1year Maintenance: Zanubrutinib continued until progression **Intervention Names:** - Drug: Zanubrutinib,Obinutuzumab **Label:** Elder Patients（≥65） **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Induction: Zanubrutinib and R-BAC 6 cycles Consolidation: ASCT（If eligible for transplantation），Otherwise, the patient was directly entered into maintenance treatment Maintenance: Zanubrutinib continued until progression **Intervention Names:** - Drug: Zanubrutinib and R-BAC **Label:** Young Patients with High risk （≥18，<65） **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Elder Patients（≥65） **Description:** Zanubrutinib, 160mg PO BID. C1D17 continuously for 1 year or until progressive disease； Obinutuzumab ：Obinutuzumab will be administered 1,000 mg intravenously on days 1, 8, and 15 of cycle 1, then 1,000 mg on day 1 of cycles 2 to 6, then 1,000 mg every 8 weeks，up to 20 doses. 1 cycle = 28 days. Maintenance: Zanubrutinib, 160mg PO BID **Name:** Zanubrutinib,Obinutuzumab **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Young Patients with High risk （≥18，<65） **Description:** Induction: Zanubrutinib and R-BAC 6 cycles Consolidation: ASCT（If eligible for transplantation），Otherwise, the patient was directly entered into maintenance treatment Maintenance: Zanubrutinib continued until progression **Name:** Zanubrutinib and R-BAC **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria. **Measure:** Objective Response rate after induction **Time Frame:** 3 yeas #### Secondary Outcomes **Description:** Complete remission rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria. **Measure:** Complete remission rate after Interim treatment **Time Frame:** 3 years **Description:** MRD negativity rate after induction treatment **Measure:** MRD negativity rate after induction **Time Frame:** 3 years **Description:** The time from start of treatment to progression or death from any cause **Measure:** Progression free survival (PFS) **Time Frame:** 5 years **Description:** The time from start of treatment to death from any cause **Measure:** Overall survival (OS) **Time Frame:** 5 years **Description:** Adverse Events will be determined and graded on the basis of investigator assessments according to NCI CTC AE 5.0 **Measure:** Percentage of Participants With Adverse Events **Time Frame:** 5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Voluntary participation in clinical study; Fully understand and understand the study and sign the informed consent form (ICF);Willingness to follow and ability to complete all study steps 2. Histopathologically confirmed mantle cell lymphoma according to the 5th edition of the World Health Organization (WHO)，previous untreatment for mantle-cell lymphoma (MCL) 3. The elderly group ≥65 years old;The young group was ≥18 years old and \< 65 years old. 4. ECOG Performance Status 0-3 5. Life expectancy of at least 3 months 6. At least one evaluable lesion according to 2014 Lugano criteria; 7. Proper functioning of the major organs, no major heart, lung, liver, kidney, or immunodeficiency (no blood transfusion, granulocyte colony-stimulating factor, or other medical support within 7 days before starting the study) :Hemoglobin (HB)≥60 g/L;Absolute neutrophil count(ANC)≥0.5×10\^9/L;Platelet count（PLT）≥50×10\^9/L;AST and ALT ≤ 2.5 x ULN；Total bilirubin ≤ 1.5 times the ULN;Ccr≥40ml/min（Cockcroft-Gault ）；Left Ventricular Ejection Fraction (LVEF) ≥ 50% Exclusion Criteria: 1. The presence of other tumors could affect the study medication or interfere with the results; 2. Patients require treatment with strong or moderate CYP3A inhibitors; 3. Pregnant or lactating women; 4. Known to be allergic to the test drug ingredients; 5. Subjects of childbearing potential who are unwilling to use highly effective contraceptive methods; 6. Live vaccination was administered within 28 days prior to treatment 7. Known human immunodeficiency virus (HIV) infection or suggested active B or C infection The following serologic status of hepatitis C virus infection: 1) Hepatitis B virus (HBV) DNA positive. Positive hepatitis B surface antigen (HBsAg) or anti-hepatitis B core antibody (HBcAb) seropositive if HBV DNA is undetectable and willing to accept Monthly surveillance for HBV reactivation was eligible. 2) Hepatitis C virus (HCV) antibody positive. For patients with HCV antibodies present, if undetectable HCV RNA, can be included; 8. Severe coagulopathy and serious impairment of heart, brain, lung, liver, kidney and other organs 9. History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months; 10. Any risk that is considered by the investigator to be likely to affect the safety of the subjects or to pose a risk to the study And vital diseases, medical conditions, or organ system insufficiency. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** keshu Zhou **Phone:** 0371-65587306 **Role:** CONTACT ## 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 ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11220 - Name: Lymphoma - Relevance: HIGH - As Found: Lymphoma - ID: M11222 - Name: Lymphoma, Non-Hodgkin - Relevance: HIGH - As Found: Lymphoma, Non-Hodgkin - ID: M22307 - Name: Lymphoma, Mantle-Cell - Relevance: HIGH - As Found: Lymphoma, Mantle-Cell - 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: Lymphoma - ID: T3601 - Name: Mantle Cell Lymphoma - Relevance: HIGH - As Found: Mantle Cell Lymphoma ### Condition Browse Module - Meshes - ID: D000008223 - Term: Lymphoma - ID: D000020522 - Term: Lymphoma, Mantle-Cell - ID: D000008228 - Term: Lymphoma, Non-Hodgkin ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000092004 - Term: Tyrosine 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: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M42199 - Name: Zanubrutinib - Relevance: HIGH - As Found: Mobile Health - ID: M288906 - Name: Obinutuzumab - Relevance: HIGH - As Found: Nervous - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M2889 - Name: Tyrosine 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 - ID: T22 - Name: Tyrosine - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000543332 - Term: Obinutuzumab - ID: C000629551 - Term: Zanubrutinib ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427200 **Brief Title:** Efficacy and Safety of Lactoferrin in Heart Failure Patients **Official Title:** Efficacy and Safety of Lactoferrin in Heart Failure Patients #### Organization Study ID Info **ID:** CL(3530) #### Organization **Class:** OTHER **Full Name:** Cairo University #### Secondary ID Infos **Domain:** the general organization for teaching hospitals and institutes (GOTHI) **ID:** IHC00072 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2027-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-18 **Study First Submit QC Date:** 2024-05-18 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cairo University #### Responsible Party **Investigator Affiliation:** Cairo University **Investigator Full Name:** reham mohamed saied salem **Investigator Title:** Teaching assistant at Faculty of Pharmacy Cairo University **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False ### Description Module **Brief Summary:** This study will be conducted to determine the efficacy and safety of lactoferrin versus oral iron versus lactoferrin plus oral iron as an add on therapy in reduced ejection fraction heart failure patients with iron deficiency. •Patients will be randomly distributed into the three groups * All patients will be subjected to baseline data assessment * Follow up after 12 weeks ### Conditions Module **Conditions:** - Heart Failure With Reduced Ejection Fraction **Keywords:** - Lactoferrin - oral iron - reduced ejection fraction - iron deficiency - heart failure - clinical trial ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 114 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: oral Iron **Label:** group "oral iron" **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Lactoferrin **Label:** group "lactoferrin" **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Drug: lactoferrin and oral iron **Label:** group "lactoferrin and oral iron" **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - group "oral iron" **Description:** oral iron once daily during or after meals as add-on therapy for 12 weeks. **Name:** oral Iron **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - group "lactoferrin" **Description:** lactoferrin twice daily before meals as add-on therapy for 12 weeks. **Name:** Lactoferrin **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - group "lactoferrin and oral iron" **Description:** lactoferrin twice daily before meals and oral iron once daily during or after meals as add-on therapy for 12 weeks. **Name:** lactoferrin and oral iron **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** • Change in health-related quality of life (HR-QoL) as evaluated by Minnesota Living with Heart Failure Questionnaire (MLHFQ) minimum score:0 maximum score:105 minimum score is a better outcome **Measure:** Change in health-related quality of life (HR-QoL) **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age: 18-65 years old. 2. Chronic heart failure (\> 6 months duration) with reduced ejection fraction defined as LVEF ≤ 40%. 3. NYHA-class II or III or IV with stable symptoms for at least the past 3 months. 4. Stabilized on beta blockers, renin-angiotensin system inhibitor (ACEI/ARB) or angiotensin receptor-neprilysin inhibitors (ARNIs), mineralocorticoid receptor antagonists (MRAs) and sodium-glucose co-transporter 2 Inhibitors (SGLT2i) and diuretics as needed. 5. No dose changes of heart failure drugs during the last 2 weeks (exception: diuretics) 6. No introduction of a new heart failure drug class during the last 4 weeks. 7. Iron deficiency: serum ferritin level of 15 to 100 ng/mL or a serum ferritin level of 101 to 299 ng/mL with transferrin saturation of less than 20%. Exclusion Criteria: * 1. Arrythmia including atrial fibrillation (AF) with poorly controlled ventricular rate at rest (\> 100 beats/min). 2. Recent cardiac related hospitalizations in the past 3 months. 3. Known active infection. 4. Associated chronic medical disorder (chronic kidney disease (creatinine clearance \< 60 ml/min), liver disease (ALT or AST \> 3× upper limit of normal), peptic ulcer or chronic blood loss). 5. Associated bleeding disorder. 6. Previous iron supplement in past 3 months. 7. Anemia requiring blood transfusion (haemoglobin (Hb) \< 7 g/dL). 8. Folic acid or vitamin B12 deficiency. 9. Hypersensitivity to lactoferrin or iron. 10. Haemoglobinopathies (G6PD, thalassemia's, sickle cell disease). 11. Pregnancy and lactation. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M9421 - Name: Heart Failure - Relevance: HIGH - As Found: Heart Failure - ID: M20857 - Name: Anemia, Iron-Deficiency - Relevance: LOW - As Found: Unknown - ID: M2781 - Name: Iron Deficiencies - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006333 - Term: Heart Failure ### Intervention Browse Module - Ancestors - ID: D000014131 - Term: Trace Elements - ID: D000018977 - Term: Micronutrients - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000890 - Term: Anti-Infective Agents ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M10533 - Name: Iron - Relevance: HIGH - As Found: Gastric - ID: M10799 - Name: Lactoferrin - Relevance: HIGH - As Found: Polyethylene glycol - ID: M21009 - Name: Micronutrients - Relevance: LOW - As Found: Unknown - ID: M16885 - Name: Trace Elements - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000007501 - Term: Iron - ID: D000007781 - Term: Lactoferrin ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427187 **Brief Title:** Mechanical Thrombectomy of Acute Ischemic Stroke Anterior Circulation Distal Vessel Occlusion **Official Title:** Outcomes of Mechanical Thrombectomy of Acute Ischemic Stroke Anterior Circulation Distal Vessel Occlusion #### Organization Study ID Info **ID:** Mechanical throbectomy #### Organization **Class:** OTHER **Full Name:** Assiut University ### Status Module #### Completion Date **Date:** 2027-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-18 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assiut University #### Responsible Party **Investigator Affiliation:** Assiut University **Investigator Full Name:** Mohamed Zayed Saber **Investigator Title:** assistant lecturer **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Ischemic stroke continues to be of the leading causes of disability and death. Distal vessel occlusion one of most presenting and disabling varieties of ischemic stroke. Distal vessel occlusion stroke is a type of ischemic stroke that affects the small arteries in the brain, usually beyond the M2 segment of the middle cerebral artery. These strokes can cause various neurological symptoms depending on the location and size of the occluded vessel and the extent of the brain tissue damage **Detailed Description:** DMVOs are defined by the Distal Thrombectomy Summit Group consensus statement as thromboembolic occlusion of the anterior cerebral artery, M2-M4 middle cerebral artery (MCA), posterior cerebral artery (PCA), posterior inferior cerebellar artery, anterior inferior cerebellar artery or superior cerebellar artery. It is estimated that 25-40% of all AIS is due to DMVO.Though distal vessel occlusion associated with poor disabling comorbidities'.With different aetiology weather primary Embolic from (heart, carotid or aorta),thrombotic (atherosclerotic, hypertension or Diabetes ,smoking \&hyperlipidaemia) or Secondary distal vessel occlusion that occurs as a complication of a proximal large vessel occlusion, either spontaneously or after treatment with intravenous thrombolysis or endovascular thrombectomy. This can be due to thrombus fragmentation and migration or incomplete reperfusion of the affected vascular territory . Endovascular thrombectomy is well established as a highly effective treatment for acute ischemic stroke (AIS) due to proximal, large vessel occlusions (PLVOs). Recent advances in stent retriever and aspiration catheter technology are more promising results to reach more distal vessels, with a good outcome. However, MT in M2 emerging with different technique using stent Retriever or aspiration or both nowadays, evidence of other MT in distal vessel occlusion is poor. ### Conditions Module **Conditions:** - Acute Ischemic Stroke ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Each presenting Patient subjected to: * careful history including Age, Sex, comorbid diseases (hypertension, Diabetes, dyslipidemia, cardiac disease...), time from onset to treatment * examination: Vital signs * NIHSS at admission * Lab investigation: basic lab, metabolic profile \& Lipid profile * The diagnosis was made using a standard CT stroke protocol including CT head Aspect score, arterial CT angiography, and perfusion CT. In some cases, primary stroke MRI was performed including fluid attenuated inversion recovery (FLAIR), diffusion weighted imaging (DWI): in order to evaluate location of occluded vessel, size of ischemic core \& penumbra). All patients received either mechanical thrombectomy (MT) with or without intra-venous thrombolysis (IVT) according to standard medical guidelines. MT was performed using approved aspiration catheters or stent-retrievers or both. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Each presenting Patient with acute distal vessel occlusion of anterior circulation with (A1-A3)or (M2-M3) either mechanical thrombectomy (MT) with or without intra-venous thrombolysis (IVT) according to standard medical guidelines. MT was performed using approved aspiration catheters or stent-retrievers or both. **Intervention Names:** - Device: an array of devices are used in thrombectomy. These include guide catheters, stent-retrievers, microcatheters, aspiration catheters, and aspiration pump systems **Label:** distal vessel occlusion Mechanical thromectomy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - distal vessel occlusion Mechanical thromectomy **Description:** each patient with distal vessel occlusion subjected to mechanical thrombectomy using aspiration technique or stent retriever **Name:** an array of devices are used in thrombectomy. These include guide catheters, stent-retrievers, microcatheters, aspiration catheters, and aspiration pump systems **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The original description was based on the angiographic appearances of the treated occluded vessel and the distal branches: grade 0: no perfusion grade 1: penetration with minimal perfusion grade 2: partial perfusion grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualized grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal grade 3: complete perfusion **Measure:** Thrombolysis in Cerebral Infarction (TICI) **Time Frame:** 1 day , 10 day **Description:** grade 0: no perfusion grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion grade 2 grade 2a: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory (e.g. in one major division of the middle cerebral artery (MCA) and its territory) grade 2b: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory (e.g. in two major divisions of the MCA and their territories) grade 2c: near complete perfusion except for slow flow or distal emboli in a few distal cortical vessels this was not part of the original mTICI score, but was added later and has since become widely accepted as being part of the scoring 4 grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches **Measure:** modified Thrombolysis in Cerebral Infarction scale (mTICI) **Time Frame:** 1 day , 10 day #### Secondary Outcomes **Description:** 90 Days modified Rankin scale (mRS) score The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients who have had a stroke, as follows 0: No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead **Measure:** mRS **Time Frame:** three months **Description:** Safety outcomes were defined as 90-day mortality and occurrence of symptomatic intracranial haemorrhage (sICH). **Measure:** Safety outcomes were defined as 90-day mortality and occurrence of symptomatic intracranial haemorrhage (sICH). **Time Frame:** three months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * a. Inclusion criteria: 1. Diagnosis of an acute ischemic stroke due to an occlusion of the anterior cerebral artery (ACA) in the A1-A3 segment 2. Diagnosis of an acute ischemic stroke due to an occlusion of the middle cerebral artery in the distal M2 segment or the M3 segment. Exclusion Criteria: 1. Posterior circulation small vessel occlusion 2. Tandem lesions with occlusion of the ipsilateral ICA were excluded. **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:** Mohamed zayed, Master degree **Phone:** +20109809943 **Role:** CONTACT ### References Module #### References **Citation:** Kunz WG, Almekhlafi MA, Goyal M. Distal Vessel Occlusions: When to Consider Endovascular Thrombectomy. Stroke. 2018 Jul;49(7):1581-1583. doi: 10.1161/STROKEAHA.118.021887. Epub 2018 Jun 18. No abstract available. **PMID:** 29915118 **Citation:** Sepp D, Hernandez Petzsche MR, Zarth T, Wunderlich S, Ikenberg B, Maegerlein C, Zimmer C, Berndt MT, Boeckh-Behrens T, Kirschke JS. Mechanical thrombectomy of distal cerebral vessel occlusions of the anterior circulation. Sci Rep. 2023 Apr 7;13(1):5730. doi: 10.1038/s41598-023-32634-0. **PMID:** 37029202 **Citation:** Saver JL, Chapot R, Agid R, Hassan A, Jadhav AP, Liebeskind DS, Lobotesis K, Meila D, Meyer L, Raphaeli G, Gupta R; Distal Thrombectomy Summit Group*dagger. Thrombectomy for Distal, Medium Vessel Occlusions: A Consensus Statement on Present Knowledge and Promising Directions. Stroke. 2020 Sep;51(9):2872-2884. doi: 10.1161/STROKEAHA.120.028956. Epub 2020 Aug 6. No abstract available. Erratum In: Stroke. 2020 Oct;51(10):e296. **PMID:** 32757757 **Citation:** Kobeissi H, Bilgin C, Ghozy S, Kadirvel R, Kallmes DF, Brinjikji W. A review of acute ischemic stroke caused by distal, medium vessel occlusions. Interv Neuroradiol. 2023 Aug 29:15910199231197616. doi: 10.1177/15910199231197616. Online ahead of print. **PMID:** 37644821 **Citation:** Lima FO, Furie KL, Silva GS, Lev MH, Camargo EC, Singhal AB, Harris GJ, Halpern EF, Koroshetz WJ, Smith WS, Nogueira RG. Prognosis of untreated strokes due to anterior circulation proximal intracranial arterial occlusions detected by use of computed tomography angiography. JAMA Neurol. 2014 Feb;71(2):151-7. doi: 10.1001/jamaneurol.2013.5007. **PMID:** 24323077 **Citation:** Elhorany M, Rosso C, Shotar E, Baronnet-Chauvet F, Premat K, Lenck S, Crozier S, Corcy C, Bottin L, Mansour OY, Talbi A, El-Din EAT, Fadel WA, Sourour NA, Alamowitch S, Samson Y, Clarencon F. Safety and effectiveness of mechanical thrombectomy for primary isolated distal vessel occlusions: A monocentric retrospective comparative study. J Neuroradiol. 2022 Jun;49(4):311-316. doi: 10.1016/j.neurad.2022.03.008. Epub 2022 Apr 6. **PMID:** 35397949 **Citation:** Guenego A, Mine B, Bonnet T, Elens S, Vazquez Suarez J, Jodaitis L, Ligot N, Naeije G, Lubicz B. Thrombectomy for distal medium vessel occlusion with a new generation of Stentretriever (Tigertriever 13). Interv Neuroradiol. 2022 Aug;28(4):444-454. doi: 10.1177/15910199211039926. Epub 2021 Sep 13. **PMID:** 34516332 **Citation:** Alawieh AM, Chalhoub RM, Al Kasab S, Jabbour P, Psychogios MN, Starke RM, Arthur AS, Fargen KM, De Leacy R, Kan P, Dumont TM, Rai A, Crosa RJ, Maier I, Goyal N, Wolfe SQ, Cawley CM, Mocco J, Tjoumakaris SI, Howard BM, Dimisko L, Saad H, Ogilvy CS, Crowley RW, Mascitelli JR, Fragata I, Levitt MR, Kim JT, Park MS, Gory B, Polifka AJ, Matouk C, Grossberg JA, Spiotta AM; STAR Collaborators. Multicenter investigation of technical and clinical outcomes after thrombectomy for distal vessel occlusion by frontline technique. J Neurointerv Surg. 2023 Sep;15(e1):e93-e101. doi: 10.1136/jnis-2022-019023. Epub 2022 Aug 2. **PMID:** 35918129 **Citation:** Sweid A, Head J, Tjoumakaris S, Xu V, Shivashankar K, Alexander TD, Dougherty JA, Gooch MR, Herial N, Hasan D, DePrince M, Rosenwasser RH, Jabbour P. Mechanical Thrombectomy in Distal Vessels: Revascularization Rates, Complications, and Functional Outcome. World Neurosurg. 2019 Oct;130:e1098-e1104. doi: 10.1016/j.wneu.2019.07.098. Epub 2019 Jul 16. **PMID:** 31323418 **Citation:** Atchaneeyasakul K, Malik AM, Yavagal DR, Haussen DC, Jadhav AP, Bouslama M, Kenmuir CL, Desai S, Grossberg JA, Chaturvedi S, Jovin TG, Nogueira RG. Thrombectomy Outcomes in Acute Ischemic Stroke due to Middle Cerebral Artery M2 Occlusion with Stent Retriever versus Aspiration: A Multicenter Experience. Interv Neurol. 2020 Jan;8(2-6):180-186. doi: 10.1159/000500198. Epub 2019 Jun 18. **PMID:** 32508900 **Citation:** Sacks D, Baxter B, Campbell BCV, Carpenter JS, Cognard C, Dippel D, Eesa M, Fischer U, Hausegger K, Hirsch JA, Hussain MS, Jansen O, Jayaraman MV, Khalessi AA, Kluck BW, Lavine S, Meyers PM, Ramee S, Rufenacht DA, Schirmer CM, Vorwerk D. Multisociety Consensus Quality Improvement Revised Consensus Statement for Endovascular Therapy of Acute Ischemic Stroke: From the American Association of Neurological Surgeons (AANS), American Society of Neuroradiology (ASNR), Cardiovascular and Interventional Radiology Society of Europe (CIRSE), Canadian Interventional Radiology Association (CIRA), Congress of Neurological Surgeons (CNS), European Society of Minimally Invasive Neurological Therapy (ESMINT), European Society of Neuroradiology (ESNR), European Stroke Organization (ESO), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Interventional Radiology (SIR), Society of NeuroInterventional Surgery (SNIS), and World Stroke Organization (WSO). J Vasc Interv Radiol. 2018 Apr;29(4):441-453. doi: 10.1016/j.jvir.2017.11.026. Epub 2018 Mar 1. No abstract available. **PMID:** 29478797 **Citation:** Zaidat OO, Yoo AJ, Khatri P, Tomsick TA, von Kummer R, Saver JL, Marks MP, Prabhakaran S, Kallmes DF, Fitzsimmons BF, Mocco J, Wardlaw JM, Barnwell SL, Jovin TG, Linfante I, Siddiqui AH, Alexander MJ, Hirsch JA, Wintermark M, Albers G, Woo HH, Heck DV, Lev M, Aviv R, Hacke W, Warach S, Broderick J, Derdeyn CP, Furlan A, Nogueira RG, Yavagal DR, Goyal M, Demchuk AM, Bendszus M, Liebeskind DS; Cerebral Angiographic Revascularization Grading (CARG) Collaborators; STIR Revascularization working group; STIR Thrombolysis in Cerebral Infarction (TICI) Task Force. Recommendations on angiographic revascularization grading standards for acute ischemic stroke: a consensus statement. Stroke. 2013 Sep;44(9):2650-63. doi: 10.1161/STROKEAHA.113.001972. Epub 2013 Aug 6. No abstract available. **PMID:** 23920012 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002561 - Term: Cerebrovascular Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010335 - Term: Pathologic Processes - ID: D000020520 - Term: Brain Infarction - ID: D000002545 - Term: Brain Ischemia - ID: D000007238 - Term: Infarction - ID: D000009336 - Term: Necrosis ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10543 - Name: Ischemia - Relevance: HIGH - As Found: Ischemic - ID: M22306 - Name: Stroke - Relevance: HIGH - As Found: Stroke - ID: M2400 - Name: Ischemic Stroke - Relevance: HIGH - As Found: Ischemic Stroke - ID: M5793 - Name: Cerebral Infarction - Relevance: HIGH - As Found: Ischemic Stroke - ID: M10282 - Name: Infarction - Relevance: LOW - As Found: Unknown - ID: M5810 - Name: Cerebrovascular Disorders - 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: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M22305 - Name: Brain Infarction - Relevance: LOW - As Found: Unknown - ID: M5794 - Name: Brain Ischemia - Relevance: LOW - As Found: Unknown - ID: M12284 - Name: Necrosis - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000020521 - Term: Stroke - ID: D000083242 - Term: Ischemic Stroke - ID: D000002544 - Term: Cerebral Infarction - ID: D000007511 - Term: Ischemia ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427174 **Brief Title:** Analgesic Efficacy of Us Guided Fascia Iliaca Block Versus Caudal Block in Pediatric Graft Surgeries **Official Title:** Analgesic Efficacy of Us Guided Fascia Iliaca Block Versus Caudal Block in Pediatric Graft Surgeries #### Organization Study ID Info **ID:** FB vs CB #### Organization **Class:** OTHER **Full Name:** Assiut University ### Status Module #### Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-18 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-04 **Type:** ESTIMATED #### Start Date **Date:** 2025-03 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-18 **Study First Submit QC Date:** 2024-05-18 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assiut University #### Responsible Party **Investigator Affiliation:** Assiut University **Investigator Full Name:** Ahmed Atef Ahmed **Investigator Title:** Dr **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The study is aimed to determine which of the two methods , either the fascia iliaca block or the caudal block is better in managing the post operative pain and by which decreasing the consumption of analgesic drugs post operatively and making the patient more comfortable. **Detailed Description:** Split-thickness skin grafting is the current standard of care for the reconstructive procedures in managing burn injuries and traumatic tissue defects. Harvesting split-thickness skin creates a new partial thickness wound that is referred to as the donor site.(1) Donor site pain is one of the most distressing symptoms reported by patients in the early postoperative period.4,5 Larger donor sites stimulate a greater number of pain receptors and consequently pain is proportional to the size of the graft harvested.6 Often, the donor site is reported to be more painful than the recipient site,7 affecting early mobilization, sleep, and need for analgesics postoperatively.(1) Most commonly split thickness auto-grafts are harvested from a convenient and minimally aesthetically intrusive site; often the lateral thigh area, which is innervated by lateral femoral cutaneous nerve (LFCN). However if a larger graft area in needed then it will be obtained from the anterior aspect of the thigh, which is innervated by the femoral nerve.(2) Regional nerve blockade has been proposed for skin graft harvest and proofed to provide better and longer standing analgesia.(2) Application of fascia iliaca compartment block involves the distribution of anesthesia to the territories of the femoral and lateral cutaneous nerves(3) American society of regional anesthesia and pain medicine recommendations on local anesthetics in pediatric regional anesthesia in 2018 stated that the ultrasound guided fascial plane blocks as fascia iliaca block can be successfully and safely performed using a recommended dose of 0.25-0.75 mg/kg of bupivacaine 0.25%.(4) Prolongation of analgesia after any surgery is the goal of any phsyician ,and Fascia Iliaca Block (FIB), which is widely used for postoperative analgesia in many surgeries, is a nerve block technique with proven efficacy. but which has the superior effect of numbing the pain ..Is it the fascia iliaca erve block or the caudal block . The objective of this study is to compare post operative analgesic effect and safety of fascia iliaca nerve block versus caudal block in pediatric patient undergoing a graft surgery . ### Conditions Module **Conditions:** - Fascia Iliaca Block, Analgesia, Pediatric Surgeries ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Masking Description:** Patients and anesthesiologist won't know which group is patients will selected **Who Masked:** - PARTICIPANT - CARE_PROVIDER **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** For the group who will receive the fascia iliaca block .... After induction of the general anesthesia and before skin incision, fascia iliaca block will be performed in the patient while he is in the supine position after sterilization of skin over the groin area at the side from which split thickness graft will be taken, high frequency ultrasound probe **Intervention Names:** - Drug: Fascia iliaca block **Label:** Fascia iliaca group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** And the second group will receive the caudal block, we use bupivacaine 0.5 mg / kg. With the patient in the left lateral decubitus position and the hips and knees flexed, the sacral hiatus can be identified .First of all, the posterior superior iliac spines are palpated via anatomical landmarks, the line between both spines (Tuffier's line) representing the base of an equilateral triangle the tip of which indicates the position of the sacral hiatus. The sacrococcygeal ligament can be palpated between the two sacral cornua, which is where the needle should penetrate the skin at an approximate 45° angle. Once the ligament has been passed, a flatter angle is adjusted by descending the needle before it can be advanced to the correct final position. **Intervention Names:** - Drug: Caudal block **Label:** Caudal block **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Fascia iliaca group **Description:** For the group who will receive the fascia iliaca block .... After induction of the general anesthesia and before skin incision, fascia iliaca block will be performed in the patient while he is in the supine position **Name:** Fascia iliaca block **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Caudal block **Description:** second group will receive the caudal block, we use bupivacaine 0.5 mg / kg. **Name:** Caudal block **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Postoperative analgesia using FLACC score **Measure:** Postoperative analgesia using FLACC score **Time Frame:** 1-24 hour postiperative ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 2- 12 years. ASA I - II Scheduled for split thickness grafting. Availability and suitability of lateral and anterior aspects of the thigh as a donor site. Exclusion Criteria: * Patient's gaurdian refusal to participate in the study. Known allergy to local anesthetics Coagulopathy. Patient with motor or sensory deficits in lower extremities. Prior surgery of the inguinal or suprainguinal area . Children who are morbidly obese (BMI≥30) because ultrasound guided regional anesthesia could be too technically difficult. **Healthy Volunteers:** True **Maximum Age:** 12 Years **Minimum Age:** 2 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ahmed Mohamed Atef **Phone:** 00201003029794 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Mohamed Talaat Mohamed **Phone:** 00201062012031 **Role:** CONTACT ### References Module #### References **Citation:** Wiegele M, Marhofer P, Lonnqvist PA. Caudal epidural blocks in paediatric patients: a review and practical considerations. Br J Anaesth. 2019 Apr;122(4):509-517. doi: 10.1016/j.bja.2018.11.030. Epub 2019 Feb 1. **PMID:** 30857607 **Citation:** Bromage PR. A comparison of the hydrochloride salts of lignocaine and prilocaine for epidural analgesia. Br J Anaesth. 1965 Oct;37(10):753-61. doi: 10.1093/bja/37.10.753. No abstract available. **PMID:** 5847259 **Citation:** Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138. **PMID:** 12421743 **Citation:** Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7. **PMID:** 9220806 **Citation:** Suresh S, Ecoffey C, Bosenberg A, Lonnqvist PA, de Oliveira GS Jr, de Leon Casasola O, de Andres J, Ivani G. The European Society of Regional Anaesthesia and Pain Therapy/American Society of Regional Anesthesia and Pain Medicine Recommendations on Local Anesthetics and Adjuvants Dosage in Pediatric Regional Anesthesia. Reg Anesth Pain Med. 2018 Feb;43(2):211-216. doi: 10.1097/AAP.0000000000000702. **PMID:** 29319604 **Citation:** Shteynberg A, Riina LH, Glickman LT, Meringolo JN, Simpson RL. Ultrasound guided lateral femoral cutaneous nerve (LFCN) block: safe and simple anesthesia for harvesting skin grafts. Burns. 2013 Feb;39(1):146-9. doi: 10.1016/j.burns.2012.02.015. Epub 2012 May 30. **PMID:** 22657583 **Citation:** Shank ES, Martyn JA, Donelan MB, Perrone A, Firth PG, Driscoll DN. Ultrasound-Guided Regional Anesthesia for Pediatric Burn Reconstructive Surgery: A Prospective Study. J Burn Care Res. 2016 May-Jun;37(3):e213-7. doi: 10.1097/BCR.0000000000000174. **PMID:** 25412051 **Citation:** Sinha S, Schreiner AJ, Biernaskie J, Nickerson D, Gabriel VA. Treating pain on skin graft donor sites: Review and clinical recommendations. J Trauma Acute Care Surg. 2017 Nov;83(5):954-964. doi: 10.1097/TA.0000000000001615. **PMID:** 28598907 ## 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: M5315 - Name: Bupivacaine - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427161 **Brief Title:** Dextrose Prolotherapy Versus LLLT in Treatment of Obstructive Sleep Apnea **Official Title:** Dextrose Prolotherapy Versus Low Level Laser Therapy in Treatment of Patients With Obstructive Sleep Apnea Syndrome #### Organization Study ID Info **ID:** R.23.03.2095-2023/03/07 #### Organization **Class:** OTHER **Full Name:** Mansoura University ### Status Module #### Completion Date **Date:** 2024-04-21 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-01-05 **Type:** ACTUAL #### Start Date **Date:** 2023-04-12 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mansoura University #### Responsible Party **Investigator Affiliation:** Mansoura University **Investigator Full Name:** Amira attia **Investigator Title:** Assistant professor of oral and maxillo-facial surgery Faculty of Dentistry, Mansoura University **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study was conducted on 26 patients with obstructive sleep apnea. The patients were divided randomly and equally into two equal groups. In group I, the patients were treated with LLLT, while in group II, the patients were treated with dextrose injection. The patients were evaluated by: Medical history utilizing sleep unit medical sheet, physical examination including: anthropometric measures, epworth sleepiness scale, and Berlin questioner, and Polysomnography **Detailed Description:** This study was conducted on 26 patients with OSA attending to sleep disorders breathing Unit, Chest Department and oral and maxillofacial department at Mansoura University confirmed by polysomnography. The study was implemented over 2 months. The patients were divided randomly and equally into two therapy groups each compromise 13 patients: Group I: patients will be treated with LLLT. Group II: patients will be treated with dextrose injection. Interventions: The LLLT group received the laser application at 8 points, once a week, over a 2-month period, totaling 8 sessions. Each point was stimulated for 8 seconds in the soft palate, uvula, pharyngeal walls, palatine tonsils, and on the tongue base. LLLT protocol: Diode laser 810nm in continuous contact mode will be used, and the radiant energy will be 2J (250uw X 8 sec) for each point. Total energy will be 16J (2J X 8 points) for each session. Dextrose injection Protocol: 25% dextrose was injected in the same 8 points; 1/2 ml for each point, total 4ml for each session. The injection was done weekly, up to 4 sessions. Clinical assessment * Medical history utilizing sleep unit medical sheet will be taken from all patients: Attention was given to Night symptoms such as snoring, choking, witnessed apnea, bad dreams, and nocturia, and daytime symptoms (morning headache, excessive daytime sleepiness. * Physical examination including: Anthropometric measures: Height, weight, body-mass index (BMI), teeth imprint, abdominal circumference, Epworth sleepiness scale (Arabic version), and Berlin questioner (Arabic version) * Polysomnography ### Conditions Module **Conditions:** - Obstructive Sleep Apnea **Keywords:** - Dextrose - LLLT - obstructive sleep apnea ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Parallel Assignment ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 26 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** patients were treated with LLLT. **Intervention Names:** - Procedure: LLLT application - Procedure: dextrose injection **Label:** Group Ipatients were treated with LLLT. **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** patients were treated with dextrose injection. **Intervention Names:** - Procedure: LLLT application - Procedure: dextrose injection **Label:** Group II **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group II - Group Ipatients were treated with LLLT. **Description:** The LLLT group received the laser application at 8 points, once a week, over a 2-month period, totaling 8 sessions. Each point was stimulated for 8 seconds in the soft palate, uvula, pharyngeal walls, palatine tonsils, and on the tongue base. LLLT protocol: Diode laser 810nm in continuous contact mode was used, and the radiant energy was 2J (250uw X 8 sec) for each point. Total energy was 16J (2J X 8 points) for each session. **Name:** LLLT application **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Group II - Group Ipatients were treated with LLLT. **Description:** 25% dextrose was injected in the same 8 points; 1/2 ml for each point, total 4ml for each session. The injection was done weekly, up to 4 sessions. **Name:** dextrose injection **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** No chance of dozing =0, Slight chance of dozing =1, Moderate chance of dozing =2, High chance of dozing =3 **Measure:** Epworth sleepiness scale **Time Frame:** 1 week after last treatment session. **Description:** • All patients underwent full night attended polysomnography in the sleep laboratory of Mansoura university hospital, Chest department. **Measure:** Polysomnography **Time Frame:** 1 week after last treatment session. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All adult patients, diagnosed as having OSA after full night polysomnography. • BMI is between 28 kg/m2 and 40 kg/m2 at enrollment Exclusion Criteria: 1. Pregnant patients 2. Active infectious disease (flu like symptoms). 3. Serious co-morbidity such as chronic or decompensated liver disease, and chronic kidney disease with creatinine clearance less than 30%. 4. Patients with neuromuscular disorders. 5. Previous trauma to the head, and neck. 6. Obvious fixed upper airway obstructions (tumors, polyps, nasal obstruction). 7. Tonsil size ≥ +3. 8. Clinical evidence of severe chronic obstructive or restrictive pulmonary disease (for example chronic bronchitis, emphysema, pulmonary fibrosis). 9. Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism). 10. Surgical resection for cancer or congenital malformations in the larynx, tongue, or throat (with exception of tonsillectomy and/or adenoidectomy). 11. History of radiation therapy to neck or upper respiratory tract 12. Patients with any cardiac diseases such as heart failure, rheumatic heart diseases, coronary artery disease, and myocardial infarction (MI). 13. Patients take up medications that will alter pain perception. 14. History of dementia or active psychiatric disease that may impact study compliance. 15. Patients who refuse the procedure. - **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Al Mansoura City **Country:** Egypt **Facility:** Mansoura University **State:** Eldakahlia **Zip:** 35516 ### IPD Sharing Statement Module **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012120 - Term: Respiration Disorders - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000012818 - Term: Signs and Symptoms, Respiratory - ID: D000020919 - Term: Sleep Disorders, Intrinsic - ID: D000020920 - Term: Dyssomnias - ID: D000012893 - Term: Sleep Wake Disorders - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M15694 - Name: Sleep Apnea Syndromes - Relevance: HIGH - As Found: Sleep Apnea - ID: M22010 - Name: Sleep Apnea, Obstructive - Relevance: HIGH - As Found: Obstructive Sleep Apnea - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M4361 - Name: Apnea - Relevance: HIGH - As Found: Apnea - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M15623 - Name: Signs and Symptoms, Respiratory - Relevance: LOW - As Found: Unknown - ID: M22242 - Name: Parasomnias - Relevance: LOW - As Found: Unknown - ID: M22654 - Name: Sleep Disorders, Intrinsic - Relevance: LOW - As Found: Unknown - ID: M22655 - Name: Dyssomnias - Relevance: LOW - As Found: Unknown - ID: M15696 - Name: Sleep Wake Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001049 - Term: Apnea - ID: D000012891 - Term: Sleep Apnea Syndromes - ID: D000020181 - Term: Sleep Apnea, Obstructive ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427148 **Brief Title:** Feasibility and Acceptability of Biofeedback-based Virtual Reality Game for Children **Official Title:** Golden Breath: Feasibility and Acceptability of Biofeedback-based Virtual Reality Game for Children #### Organization Study ID Info **ID:** EU #### Organization **Class:** OTHER **Full Name:** Koç University ### Status Module #### Completion Date **Date:** 2024-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Koç University #### Responsible Party **Investigator Affiliation:** Koç University **Investigator Full Name:** Eysan Hanzade Umac **Investigator Title:** Research assistant **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The biofeedback-assisted VR game "Golden Breath" that investigators presented in this study was designed to meet children's healthcare needs quickly and efficiently while reducing pain and fear during medical procedures in the pediatric population. "Golden Breath" utilizes biofeedback techniques in a VR environment to ensure the active participation of children. By encouraging the practice of breathing techniques throughout the game, the game aims to reduce negative emotions associated with medical procedures. Through this innovative approach, investigators aim to provide new evidence supporting the effectiveness of VR and biofeedback interventions in pediatric clinical settings and ultimately improve children's overall experience during medical interventions. **Detailed Description:** Children's increasing interest in phones, tablets, and computer games has led to the integration of technological interventions in pediatric healthcare services. Innovations such as telemedicine, telerehabilitation, mobile health applications, virtual reality (VR), and mobile games provide easy and accessible ways to meet children's health needs. VR, in particular, has gained popularity as a technological intervention, with numerous studies evaluating its effectiveness during children's medical procedures. Research has shown that VR use during procedures like port catheter needle insertion significantly reduces pain and fear. Similarly, VR during venipuncture has been found to positively affect children's pain, fear, and anxiety levels. In addition to VR, integrating biofeedback technologies into VR experiences has shown positive effects on children's psychosocial outcomes. Studies on biofeedback-based VR games highlight their anxiety-reducing effects. For instance, a biofeedback-based VR game was found to reduce anxiety in children, and a neurofeedback video game, MindLight, significantly lowered anxiety levels. Another study found that a biofeedback-based video game during venipuncture helped distract children from the painful procedure, reducing their pain levels. Combining VR and biofeedback technologies is believed to enhance intervention outcomes. Biofeedback alone may provide overly abstract or complex visual feedback, while the increased interactivity of VR boosts user engagement. Effective attention capture and active participation are crucial for developing skills and ensuring consistency through these technologies. Biofeedback in VR helps users control their physiological parameters, which is particularly beneficial for children, who can be difficult to engage effectively. These technologies can serve as effective methods for distracting children during medical procedures. Pediatric medical procedures often cause pain, fear, and anxiety, which can persist long after the procedure and complicate treatment adherence. Therefore, controlling pain, fear, and anxiety is extremely important. Recent analyses highlight the potential of VR and biofeedback-assisted interventions to alleviate emotional distress in children. Moreover, the rise in digital engagement encourages healthcare professionals to develop new approaches to support child health in clinical settings. ### Conditions Module **Conditions:** - Pediatric Population ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Feedback was gathered from 10 pediatricians and nurses. Additionally, 5 inpatient children at Koç University Hospital provided their opinions on GoldenBreath, assessing ease of use, clarity, content appropriateness, sound volume, instruction clarity, game duration, and improvement suggestions. Based on feedback from 2 children suggesting more gold coins and longer game duration, options were added to adjust these elements in the game's menu. Stage 2: Following expert and child evaluations, a preliminary trial was conducted with 13 children at Koç University Hospital's pediatric outpatient clinic. The researcher met with children and parents ten minutes before the procedure. Children tried the game, using VR headsets and earphones during the procedure while receiving routine care. ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 15 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** To evaluate the feasibility and safety of the GoldenBreath before and after the procedure, the researchers asked the children to report their fears about the procedure. In addition, the children were asked to indicate the pain level they experienced, especially during the needle procedure. Possible missing data, withdrawal from the trial, and intervention fidelity were monitored during this process. Also, the children were monitored for fifteen minutes to see if they experienced any side effects related to the intervention. **Intervention Names:** - Other: The biofeedback-assisted VR game "Golden Breath" **Label:** Intervention **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention **Description:** The biofeedback-assisted VR game "Golden Breath" that we presented in this study was designed to meet children's healthcare needs quickly and efficiently while reducing pain and fear during medical procedures in the pediatric population. "Golden Breath" u **Name:** The biofeedback-assisted VR game "Golden Breath" **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** It is used to evaluate pain in children. The scale consists of six facial expressions. Facial expressions range from 0 points, "no pain-very happy" to 10 points, "unbearable pain-crying." (Wong-Baker Foundation. Home - wong-baker FACES foundation, 9.3.20. https://wongbakerfaces.org/) **Measure:** Pain-Wong-Baker Pain Assessment Scale **Time Frame:** immediately after the intervention **Description:** The scale consists of five facial expressions. In facial expressions, 0 indicates no fear, and 4 indicates severe fear (McKinley et al., 2008). The Turkish validity and reliability of the Child Fear Scale were conducted by Gerçeker and her colleagues (Özalp Gerçeker et al., 2018). **Measure:** Fear- Child Fear Scale **Time Frame:** baseline and immediately after the intervention **Description:** The form created by researchers using the literature to get feedback from children about GoldenBreath consists of eight questions. It includes questions such as: Did you think the game was easy to play? Was the game suitable in terms of content? Was the sound level in the game appropriate? Was it easy for you to follow the instructions in the game? Was the use of the game sufficient in terms of time throughout the process? Is there a feature you would like to add to the game? Have you ever felt uncomfortable while playing the game? **Measure:** GoldenBreath Evaluation Form **Time Frame:** During the development phase of the game **Description:** The scale was created by Hoehle (Hoehle, Aljafari, \& Venkatesh, 2016), and its Turkish adaptation was made by Güler in 2019 (Güler, 2019). This tool provides information about the colors, text styles, font sizes, transitivity, application management, etc., used in the mobile application. It is used to evaluate the properties. The scale is a 7-point Likert-type measurement tool and consists of a total of 40 questions. In our study, it was used to obtain expert opinions. **Measure:** Mobile Application Usability Scale **Time Frame:** During the development phase of the game ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients aged 4-12 * Applied to Koç University Hospital Pediatrics Outpatient Clinic Exclusion Criteria: * Children with a pain score \<2 before the procedure * Participants with previous experience with respiratory biofeedback in VR **Healthy Volunteers:** True **Maximum Age:** 12 Years **Minimum Age:** 4 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Eyşan Savaş **Phone:** 5068418841 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427135 **Brief Title:** A Multimodal Wearable Device-based Study to Evaluate the Efficacy of an Exercise Prescription Intervention in IBD **Official Title:** A Multimodal Wearable Device-based Study to Evaluate the Efficacy of an Exercise Prescription Intervention in Inflammatory Bowel Disease: a Single-center, Randomized Controlled Trial #### Organization Study ID Info **ID:** WDRY2024-K058 #### Organization **Class:** OTHER **Full Name:** Renmin Hospital of Wuhan University ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-18 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-19 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-04-25 **Study First Submit QC Date:** 2024-05-18 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ping An #### Responsible Party **Investigator Affiliation:** Renmin Hospital of Wuhan University **Investigator Full Name:** Ping An **Investigator Title:** Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This project is a multimodal wearable device-based evaluation of the efficacy of an exercise prescription intervention for inflammatory bowel disease in a This is a single-center, randomized controlled clinical study to evaluate the efficacy of an exercise prescription intervention in inflammatory bowel disease based on multimodal wearable devices. The experimental group was treated with exercise intervention therapy on top of the existing medication. **Detailed Description:** Inflammatory bowel disease (IBD) is a chronic inflammatory bowel disease that mainly involves the digestive system, including Crohn's disease (CD) and ulcerative colitis (UC).CD is characterized by abdominal pain, diarrhea, abdominal mass, fistula formation and intestinal obstruction. CD is characterized by abdominal pain, diarrhea, abdominal mass, fistula formation, and intestinal obstruction; UC is characterized by diarrhea, mucopurulent blood stools, and abdominal pain, and the peak age of onset is between 15 and 40 years old. Notably, many studies have shown that patients with inflammatory bowel disease commonly suffer from malnutrition, low body mass index (BMI), muscle atrophy, decreased bone density, and fatigue and anxiety, and that surgery is not a one-time event, with patients often requiring several surgeries. Current treatment strategies focus on medication, nutritional support and nursing care, neglecting other possible adjunctive treatments. Exercise interventions, as an effective adjunctive therapy for inflammatory bowel disease, have been shown to have anti-inflammatory, anti-muscle atrophic, and physical enhancement effects, improve psychological status, and also have beneficial effects on intestinal flora and intestinal absorption. Exercise is also economical, efficient and highly feasible, making it more acceptable to IBD patients. With the integration of physical medicine and the implementation of Healthy China, the role of exercise intervention in the majority of patients will be more important and its application will be more extensive. Multimodal wearable device is a simple and efficient miniaturized smart device commonly used in the field of exercise, which can monitor the wearer's heart rate, blood oxygen, step count, exercise data in real time, etc. This group proposes to combine the multimodal wearable device as an auxiliary device with the exercise intervention for patients with inflammatory bowel disease (IBD), which is the first of its kind in China. Most of the current studies are conducted on the conditions of small samples, single period, and single exercise modality, lack of studies on large samples and multi index evaluation, and the field has not yet formed a unified consensus on personalized exercise intervention for different levels of patients. There is still considerable work to be done on the study of exercise interventions for the treatment of inflammatory bowel disease. Therefore, this group proposes to conduct a randomized controlled trial to investigate the effects of exercise intervention on body composition and disease progression in patients with inflammatory bowel disease. ### Conditions Module **Conditions:** - Inflammatory Bowel Diseases **Keywords:** - Exercise interventions - Inflammatory Bowel Diseases - Wearable Device ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This is a prospective randomized controlled study divided into intervention and control groups. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 56 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Adding exercise intervention therapy to existing medications **Intervention Names:** - Behavioral: Exercise interventions **Label:** Exercise interventions **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** No exercise intervention, use of existing medication. **Label:** Conventional drug therapy **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Exercise interventions **Description:** Rehabilitation physician or rehabilitation therapist, to engage in physical exercise or patients, according to the medical examination data (including exercise test and physical strength test), according to their health, physical strength, and cardiovascular function status, with the form of a prescription for the type of exercise, intensity of exercise, exercise time and frequency of exercise, to put forward the precautions to be taken during exercise. **Name:** Exercise interventions **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Changes in skeletal muscle mass index (SMI) were detected using a body composition analyzer, and were considered statistically significant if they were higher in the intervention group than in the control group (P \< 0.05);Skeletal muscle mass index is calculated as the ratio of limb skeletal muscle mass (kg) to height (m) in kg/m\^2. **Measure:** skeletal muscle mass index **Time Frame:** Weeks 0, 4, 8, 12 and 16 of treatment #### Secondary Outcomes **Description:** Changes before and after the intervention were assessed by means of a quality of life questionnaire (Inflammatory Bowel Disease Questionnaire, IBDQ) with a total score of 224, the higher the better. **Measure:** Quality of life rating **Time Frame:** Weeks 0, 4, 8, 12 and 16 of treatment **Description:** Changes before and after the intervention were assessed by means of the Anxiety and Depression Scale (Hospital Anxiety and Depression Scale, HADS), with a total HADS score of 42, with higher scores indicating worse indicators. **Measure:** Psychological assessment **Time Frame:** Weeks 0, 4, 8, 12 and 16 of treatment **Description:** Changes before and after the intervention were assessed by means of a fatigue scale (Functional Assessment of Chronic Illness Therapy, FACIT), with a total FACIT score of 52, with a higher score indicating a better indicator. **Measure:** Fatigue status assessment **Time Frame:** Weeks 0, 4, 8, 12 and 16 of treatment **Description:** Detecting changes in subjects' body fat percentage using a body composition analyzer **Measure:** body fat percentage **Time Frame:** Weeks 0, 4, 8, 12 and 16 of treatment **Description:** Changes in muscle strength (kg) in the limbs of the subjects were detected using a plyometer. **Measure:** muscle power **Time Frame:** Weeks 0, 4, 8, 12 and 16 of treatment **Description:** Changes in spirometry (mL) before and after the intervention were tested using an electronic spirometry tester. **Measure:** spirometry **Time Frame:** Weeks 0, 4, 8, 12 and 16 of treatment **Description:** Test for changes in fecal calprotectin (FCP) levels in subjects before and after the intervention.The normal range for FCP is less than 100 ng/mL. **Measure:** Fecal calprotectin level **Time Frame:** Weeks 0, 4, 8, 12 and 16 of treatment **Description:** To test for changes in subjects' C-reactive protein (CPR) levels before and after the intervention.The normal range for CRP is less than 5.2 mg/l for adult males and less than 4.6 mg/l for adult females. **Measure:** C-reaction protein level **Time Frame:** Weeks 0, 4, 8, 12 and 16 of treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Commitment to comply with the study procedures and cooperate in the implementation of the full study * Age ≥ 18 years old, gender is not limited * Muscle strength examination of all four limbs is greater than or equal to grade 3 * Patients with a diagnosis of CD or UC in combination with clinical presentation, laboratory examination, endoscopy, imaging and histopathologic examination, with a disease course in mild to moderate activity or remission * Presence of low or high BMI, malnutrition, muscular dystrophy, and anxiety * Voluntarily sign a written informed consent Exclusion Criteria: * Absolute contraindications to exercise: acute stages of various diseases (e.g. cerebral hemorrhage, acute stage of myocardial infarction), severe complications, severe cardiopulmonary dysfunction, severe gastrointestinal problems (e.g. gastric perforation, intestinal obstruction), severe locomotor system disorders (e.g. severe bone fracture), as well as other diseases that are not under effective control * Relative contraindications to exercise: severe hypertension, severe diabetes, chronic pain, cardiac arrhythmia, etc * Persons with unstable vital signs * Presence of cognitive, communication disorders * Patients who have recently undergone gastrointestinal surgery (\<1 month) or who have not fully healed * Short bowel syndrome * Presence of extra-intestinal manifestations and complications that interfere with therapy, such as retinopathy, deep vein thrombosis, etc * Pregnant or lactating women * Active tuberculosis; if subjects are suspected of having active tuberculosis, chest X-ray, sputum and exclusion by clinical signs and symptoms are required * Other potential subjects who are not suitable for participation in this study **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ping An **Phone:** +8618627068700 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Renmin Hospital of Wuhan University **Name:** Ping An **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000005759 - Term: Gastroenteritis ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10444 - Name: Intestinal Diseases - Relevance: HIGH - As Found: Bowel Disease - ID: M17917 - Name: Inflammatory Bowel Diseases - Relevance: HIGH - As Found: Inflammatory Bowel Disease - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8875 - Name: Gastroenteritis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007410 - Term: Intestinal Diseases - ID: D000015212 - Term: Inflammatory Bowel Diseases ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427122 **Acronym:** EMD-U vs CAU **Brief Title:** Effect of EMD Protocol for Urge on Dermatology-specific Quality of Life **Official Title:** The Effect of the EMD Protocol for Urge Compared to Care as Usual on Dermatology-specific Quality of Life #### Organization Study ID Info **ID:** 11074 #### Organization **Class:** OTHER **Full Name:** Erasmus Medical Center #### Secondary ID Infos **Domain:** ToetsingOnline **ID:** NL84417.078.23 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-11 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-02-07 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Tamar Nijsten #### Responsible Party **Investigator Affiliation:** Erasmus Medical Center **Investigator Full Name:** Tamar Nijsten **Investigator Title:** Prof. **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The primary objective of this open randomised controlled trial is to assess the add-on effect of EMD-U compared to CAU alone, in improving dermatology-specific quality of life in patients with atopic dermatitis or prurigo nodularis who suffer from severe scratching behaviour. The main study parameter is the difference in treatment effect between EMD-U and CAU at T2, measured with the Skindex-29 symptoms scale. There are five measurement points: T0, T1 after 4 weeks, T2 after 8 weeks, T3 after 12 weeks, and T4 after 6 months. Patients are randomly allocated to either the EMD-U or CAU condition. **Detailed Description:** Rationale: The EMD protocol for urge (EMD-U) is a recently developed treatment that combines elements of Eye Movement Desensitization and Reprocessing (EMDR) therapy, Cognitive Behaviour therapy, and hypnotherapy. EMD-U aims to reduce the urge for scratching behaviour through desensitization techniques, self-registration of behaviour, and homework assignments. The EMD-U treatment has shown promising results in reducing scratching behaviour in patients with atopic dermatitis and is currently being investigated in patients with prurigo nodularis. Yet, the added value of the brief EMD-U intervention in addition to the care as usual (CAU) in improving dermatology-specific quality of life is unknown. Objective: The primary objective of the study is to assess the add-on effect of EMD-U compared to CAU alone, in improving dermatology-specific quality of life in patients with atopic dermatitis or prurigo nodularis who suffer from severe scratching behaviour. Study design: An open randomised controlled trial, with two arms: 1) EMD-U, 2) CAU (control). There are five measurement points: T0, T1 after 4 weeks, T2 after 8 weeks, T3 after 12 weeks, and T4 after 6 months. Study population: Patients with atopic dermatitis or prurigo nodularis who suffer from substantial scratching behaviour. Intervention (if applicable): Patients are randomly allocated to either the EMD-U or CAU condition. The EMD-U treatment lasts eight weeks, in which two EMD-U sessions and two phone calls take place in the first three weeks. After the first EMD-U session, patients are instructed to apply the learned technique at home until the end of the study. In the five following weeks, patients are phoned twice to ask for their experiences with the practicing at home. ### Conditions Module **Conditions:** - Atopic Dermatitis - Prurigo Nodularis **Keywords:** - EMD Protocol for Urge - Quality of Life - Itch - Scratching ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** An open randomised controlled trial, with two arms: 1) EMD-U, 2) CAU (control). ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The EMD-U treatment lasts eight weeks, in which two EMD-U sessions of 60 minutes and two phone calls take place in the first three weeks. In the five following weeks, patients are phoned twice to ask for their experiences with the practicing at home. An important part of EMD-U consists of homework exercises. These homework exercises comprise to practice/apply the intervention as learned during the sessions with the therapist, in those situations wherein the urge to scratch their skin is present. In the text below, we will explain in more detail what the treatment protocol entails. Patients in this condition receive the EMD-U treatment in addition to the care as usual. **Intervention Names:** - Behavioral: EMD Protocol for Urge - Other: Care as Usual **Label:** EMD-U **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients in the control group receive care as usual (CAU), which is the standard care of the dermatologist. In addition to completing the questionnaires at T0, 1, 2, 3, and 4 these patients are not offered any additional treatment or support aimed at their scratching behaviour. **Intervention Names:** - Other: Care as Usual **Label:** Care as Usual **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - EMD-U **Description:** During the EMD-U sessions, the patient is asked to focus on the spot on his/her skin where the urge to scratch is highest. The patient is asked to rate the level of urge to scratch this spot on a 10-point scale and to imagine that they scratch this spot as they would like. At the same time eye movements are offered for 30 seconds. This procedure is repeated until the level of urge to scratch has become nihil. This procedure is repeated for all other skin parts where the patient experiences an urge to scratch, until there are no skin parts left. As a homework assignment straight after the first session, the patient is instructed and encouraged to practice the same intervention at home. The two EMD-U sessions and two phone calls, take place in the first three weeks of the study. In the five following weeks, patients are phoned twice to ask for their experiences with the practicing at home. **Name:** EMD Protocol for Urge **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Care as Usual - EMD-U **Description:** Patients in the control group receive care as usual (CAU), which is the standard care of the dermatologist. In addition to completing the questionnaires at T0, 1, 2, 3, and 4 these patients are not offered any additional treatment or support aimed at their scratching behaviour. **Name:** Care as Usual **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** The LEC-5 is a 17-item self-report questionnaire designed to screen for potentially traumatic events in a respondent's lifetime. It identifies whether the person has gone through any of the listed events, and there is no definitive scoring procedure or interpretation involved. Respondents indicate varying levels of exposure to each type of potentially traumatic event included on a 6-point nominal scale, and respondents may endorse multiple levels of exposure to the same trauma type. The LEC-5 does not yield a total score or composite score. **Measure:** Life Events Checklist for DSM-5 (LEC-5) **Time Frame:** At start of study (T0) **Description:** The TEX-Q is a 15-item self-report questionnaire assessing patients' expectations of medical and psychological treatments. The scale of the items ranges from 0 to 10. Higher scores indicate higher expectations. The English version of the TEX-Q will be translated into Dutch, using the FACIT translation methodology. **Measure:** Treatment Expectation Questionnaire (TEX-Q) **Time Frame:** At start of study (T0) **Description:** patients are requested to assess their capacity for engaging in visuomotor activities through mental imagery, utilizing a 4-point Likert scale ranging from 0 (totally disagree) to 3 (totally agree). A higher score indicates better imagination capacity. **Measure:** Mental imagery **Time Frame:** At start of study (T0) **Description:** Number of hospital visits and medication **Measure:** Visits **Time Frame:** Six months after start study (T4) #### Primary Outcomes **Description:** The main study outcome is the dermatology-specific health-related quality of life (HRQOL). It consists of 30 items to be scored on a 5-point response scale. Outcome ranges from 0 (never) to 100 (all the time). The sum of scores is devided by the number of items answered. Higher scores indicate worse quality of life. The instrument has three subscales: symptoms, emotions, and functioning. **Measure:** Skindex-29 **Time Frame:** measured at the start of the study (T0), in week 4 (T1), in week 8 (T2), and during follow-up, in week 12 (T3) and six months after T0 (T4). #### Secondary Outcomes **Description:** This is a validated scoring system that grades the physical signs of atopic dermatitis/eczema. The minimum EASI score is 0 and the maximum EASI score is 72. Higher scores indicate higher disease activity. **Measure:** Eczema Area and Severity Index (EASI) **Time Frame:** Measured at the start of the study (T0), in week 4 (T1), in week 8 (T2), and during follow-up, in week 12 (T3) and six months after T0 (T4). **Description:** The IGA is a 5-point tool for the objective assessment of chronic prurigo. The IGA for stage of chronic nodular prurigo (CNPG) and signs of activity in chronic prurigo are used. Items range from 0 (clear) to 4 (severe). Higher scores indicate higher disease activity. **Measure:** Investigator Global Assessment (IGA) **Time Frame:** Measured at the start of the study (T0), in week 4 (T1), in week 8 (T2), and during follow-up, in week 12 (T3) and six months after T0 (T4). **Description:** It is a generic instrument that can be used in a wide range of health conditions and treatments. The EQ-5D-5L consists of a descriptive system and the EQ VAS. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The visual analogue scale (VAS), on which the patient rates his/her perceived health, ranges from 0 (the worst imaginable health) to 100 (the best imaginable health). **Measure:** EQ-5D-5L **Time Frame:** Measured at the start of the study (T0), in week 4 (T1), in week 8 (T2), and during follow-up, in week 12 (T3) and six months after T0 (T4). **Description:** The ZCCL is an 11-item self-report questionnaire measuring perceived self-control. There are two subscales: 'positive reward' (of the unwanted behaviour) and 'difficulty resisting'. Each item is scored on a 5-point Likert scale, ranging from 1 (not applicable at all) to 5 (totally applicable). Total score ranges from 11-55. Higher scores indicate less self-control. **Measure:** The Self-Control Cognition Questionnaire, Dutch: Zelfcontrole Cognitie Vragenlijst (ZCCL) **Time Frame:** Measured at the start of the study (T0), in week 4 (T1), in week 8 (T2), and during follow-up, in week 12 (T3) and six months after T0 (T4). **Description:** The PHQ-4 is a brief self-report screening tool for depression and anxiety, consisting of four items. Two items on depression, and two items on anxiety are scored with a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day). Higher scores indicate more depression and anxiety symptoms. **Measure:** Patient Health Questionnaire for anxiety and depression (PHQ-4) **Time Frame:** Measured at the start of the study (T0), in week 4 (T1), in week 8 (T2), and during follow-up, in week 12 (T3) and six months after T0 (T4). **Description:** a six-item self-report measure for the assessment of skin picking behaviour. The scale has a total score range of 0-24. Higher scores indicate more skin picking. **Measure:** Skin Picking Scale (SPS) **Time Frame:** Measured at the start of the study (T0), in week 4 (T1), in week 8 (T2), and during follow-up, in week 12 (T3) and six months after T0 (T4). ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 18 ≥ * A confirmed diagnosis of atopic dermatitis or prurigo nodularis * Suffering from persistent and frequent scratching behaviour * IGA-CPG activity score ≥ 3 OR Skindex-29 symptoms subscale score ≥ 42 * Stable course of treatment in the two weeks prior to the study (no medication change, etc.) * Sufficiently motivated to take part in a new intervention aimed at behaviour change Exclusion Criteria: * Insufficient understanding of Dutch language * Severe psychiatric disorders that require treatment first, such as delusional disorder or major depression * If medication is changed during the course of the study, the participant will be considered a drop-out from the moment the medication has changed. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Rotterdam **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Mathijs R de Veer, MSc - **Phone:** +31631016284 - **Role:** CONTACT **Country:** Netherlands **Facility:** Erasmus University Medical Center **Status:** RECRUITING **Zip:** 3015 GD #### Overall Officials **Official 1:** **Affiliation:** Erasmus University Medical Center, Department of Dermatology **Name:** Rick Waalboer-Spuij, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Erasmus University Medical Center, Department of Psychiatry, Section Medical Psychology **Name:** Leonieke W Kranenburg, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** No IPD is shared due to privacy issues **IPD Sharing:** NO ### References Module #### References **Citation:** de Veer MR, Waalboer-Spuij R, Hijnen DJ, Doeksen D, Busschbach JJ, Kranenburg LW. Reducing scratching behavior in atopic dermatitis patients using the EMDR treatment protocol for urge: A pilot study. Front Med (Lausanne). 2023 Apr 4;10:1101935. doi: 10.3389/fmed.2023.1101935. eCollection 2023. **PMID:** 37081840 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012871 - Term: Skin Diseases ### 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: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14396 - Name: Pruritus - Relevance: LOW - As Found: Unknown - ID: M7071 - Name: Dermatitis, Atopic - Relevance: LOW - As Found: Unknown - ID: M7067 - Name: Dermatitis - Relevance: HIGH - As Found: Dermatitis - ID: M7655 - Name: Eczema - Relevance: LOW - As Found: Unknown - ID: M14395 - Name: Prurigo - Relevance: HIGH - As Found: Prurigo - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life - ID: T4769 - Name: Prurigo Nodularis - Relevance: HIGH - As Found: Prurigo Nodularis ### Condition Browse Module - Meshes - ID: D000003872 - Term: Dermatitis - ID: D000011536 - Term: Prurigo ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427109 **Brief Title:** Omega-3 Fatty Acid and Colorectal Adenoma **Official Title:** Omega-3 Fatty Acid Intake and Risk of Colorectal Adenoma #### Organization Study ID Info **ID:** O3FA #### Organization **Class:** OTHER **Full Name:** DongGuk University ### Status Module #### Completion Date **Date:** 2024-02-21 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-11-30 **Type:** ACTUAL #### Start Date **Date:** 2021-11-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** DongGuk University #### Responsible Party **Investigator Affiliation:** Chung-Ang University **Investigator Full Name:** Sang Hoon Kim **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:** Patients aged \>40 years who underwent elective colonoscopies were recruited from ten institutions. Patients with a history of colorectal cancer or long-term dietary interventions were excluded. Participants completed a food frequency questionnaire (FFQ) prior to endoscopy. FFQ data were analyzed using energy-, age-, sex-, and body mass index-adjusted models; the dietary supplemental omega-3 intake was analyzed separately. Colonoscopy outcome data, including the adenoma number, pathology, and location, were collected. Participants were stratified into omega-3 consumption quartiles to assess colorectal adenoma incidence trends using P for trend analysis. ### Conditions Module **Conditions:** - Colorectal Neoplasms - Adenoma Colon ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 798 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Participants were stratified into omega-3 consumption quartiles to assess colorectal adenoma incidence trends **Name:** Dietary intake of omega-3 fatty acid **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** among groups with different omega-3 intake levels **Measure:** Incidence of Colorectal adenoma **Time Frame:** at the completion of the colonoscopy procedure ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * all patients aged more than 40 years of age, scheduled for elective colonoscopy. Exclusion Criteria: * inflammatory bowel diseases * history of colorectal neoplasms * prior gastrointestinal surgery * substance abuse including alcohol * an inability to complete the survey due to emergency endoscopy * cognitive impairments and those undergoing significant dietary modifications **Minimum Age:** 40 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Multi-center, nationwide cohort in Korea ### Contacts Locations Module #### Locations **Location 1:** **City:** Goyang-si **Country:** Korea, Republic of **Facility:** Dongguk University Ilsan Hospital **State:** Gyeonggi Province **Zip:** 14353 #### Overall Officials **Official 1:** **Affiliation:** DongGuk University **Name:** Yun Jeong Lim **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: D000007414 - Term: Intestinal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - 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 Neoplasms - ID: M3591 - Name: Adenoma - Relevance: HIGH - As Found: Adenoma - 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: 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: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System 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: D000000236 - Term: Adenoma - ID: D000015179 - Term: Colorectal Neoplasms ### 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: Angle ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427096 **Brief Title:** Effect of Healthy Family Program on Population Blood Pressure **Official Title:** Effect of Healthy Family Program on Population Blood Pressure: A 1:1 Parallel Design, Multi-Center Cluster Randomized Trial #### Organization Study ID Info **ID:** HFP2024 #### Organization **Class:** OTHER **Full Name:** Heart Health Research Center ### Status Module #### Completion Date **Date:** 2025-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-05 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-04 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-02 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-23 **Type:** ACTUAL **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-18 **Study First Submit QC Date:** 2024-05-18 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Heart Health Research Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a 1:1 parallel design, multi-center, cluster-randomized control trial. A total of 80 villages in Ruyang County, Henan Province, China, will be randomly assigned to the intervention group or control group. At least 100 participants from 30-50 families in each village will be included in this study. The intervention group will engage in a variety of strategies, including adopting a low-sodium diet, managing weight, participating in physical exercise, monitoring blood pressure, and undergoing antihypertensive treatment. These efforts will be led by healthy family instructors from the community. The control group will receive usual care. The primary endpoint of this study is the change of systolic blood pressure from baseline to 6 months, reported as the difference between intervention and control group. **Detailed Description:** This cluster-randomized control trial aims to randomly allocate 80 villages in Ruyan County to either receive a multifaceted intervention led by family healthy instructors or continue with usual care. Each village will recruit around 100 individuals aged 40-80 years, with or without hypertension. In intervention villages, a blood pressure management team, headed by healthy family instructors and family leaders, will implement various strategies including promoting a low-sodium diet, weight management, physical exercise, blood pressure monitoring, and administering antihypertensive treatment. The intervention will span 6 months, followed by another 6-month follow-up period. The primary hypothesis posits that the mean systolic blood pressure change from baseline to 6 months will be higher in the intervention group compared to the control group. The objective of this "Health Family Program" is to evaluate the efficacy of a non-healthcare provider-led multifaceted intervention in enhancing healthy lifestyles and managing blood pressure among rural residents, regardless of their hypertension status, in China. ### Conditions Module **Conditions:** - Blood Pressure ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 8000 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Residents in this group will receive multifaceted intervention including low-sodium diet, weight management, physical exercise, BP monitoring and antihypertensive treatment. **Intervention Names:** - Behavioral: Multifaceted intervention **Label:** Multifaceted intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Residents in this group will receive usual lifestyle and health care management. **Label:** Usual care **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Multifaceted intervention **Description:** The multifaceted interventions is comprised of the following components: 1. To establish a BP management team led by healthy family instructor. The team members also include family leaders and village doctors. 2. To conduct multifaceted intervention, which includes low-sodium diet, weight management, physical exercise, BP monitoring and antihypertensive treatment. **Name:** Multifaceted intervention **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The systolic blood pressure changes from baseline to 6 months for all villagers, reported as the difference between intervention and control group. **Measure:** The changes of systolic blood pressure from baseline to 6 months **Time Frame:** 6 months #### Secondary Outcomes **Description:** The systolic blood pressure changes from baseline to 12 months, reported as the difference between intervention and control group. **Measure:** The changes of systolic blood pressure from baseline to 12 months **Time Frame:** 12 months **Description:** The diastolic blood pressure changes from baseline to 6 months, reported as the difference between intervention and control group. **Measure:** The changes of diastolic blood pressure from baseline to 6 months **Time Frame:** 6 months **Description:** The percentage of blood pressure ≥130/80mmHg at 6 months, reported as the difference between intervention and control group. **Measure:** The percentage of blood pressure ≥130/80mmHg **Time Frame:** 6 months **Description:** The percentage of hypertensive participants receiving antihypertensive treatment at 6 months, reported as the difference between intervention and control group. **Measure:** The percentage of hypertensive participants receiving antihypertensive treatment **Time Frame:** 6 months **Description:** The percentage of hypertensive participants who achieved blood pressure goal \<130/80mmHg at 6 months, reported as the difference between intervention and control group. **Measure:** The percentage of hypertensive participants achieving blood pressure goal **Time Frame:** 6 months **Description:** The weight changes from baseline to 6 months, reported as the difference between intervention and control group. **Measure:** The weight changes **Time Frame:** 6 months **Description:** The incidence of major cardiovascular events including nonfatal stroke, nonfatal myocardial infarction, hospitalization for heart failure, and cardiovascular death within 6 months, reported as the difference between intervention and control group. **Measure:** The major cardiovascular events **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** 1. Village screening: The suitable villages were initially screened according to the statistical information of the number of villages and households in Ruyang County. 2. Inclusion and Exclusion Criteria for the Family Inclusion Criteria: 1. At least 2 participants between the age of 40-80 years meet the inclusion and exclusion criteria of family members and willing to participate in this study; 2. At least one family member can use the smartphone to upload BP values. Exclusion Criteria: 1. Any family member participated in the other hypertension-related programs; 2. Inappropriate for the study decided by the healthy family instructor. 3.Inclusion and Exclusion Criteria for the Family Member Inclusion Criteria: 1. 40-80 years old, regardless of BP level and antihypertensive treatment; 2. No travel plan for more than 1 month during the study period; 3. Written or fingerprinted informed consent form. Exclusion Criteria: 1. Significant cognitive dysfunction; 2. With advanced tumor, dialysis, or other serious diseases; 3. Lying in bed for a long time or unable to take care of themselves; 4. Diagnosed of secondary hypertension; 5. Having birth plans in the next six months, pregnant or lactating women; 6. Other ineligible circumstances judged by the investigators. **Healthy Volunteers:** True **Maximum Age:** 80 Years **Minimum Age:** 40 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yanna Song **Phone:** +86 17839372777 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Rong Han **Phone:** +86 13910669903 **Role:** CONTACT #### Locations **Location 1:** **City:** Luoyang **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yanna Song - **Phone:** 17839372777 - **Role:** CONTACT **Country:** China **Facility:** Ruyang County People's Hospital **State:** Henan **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Beijing Anzhen Hospital **Name:** Jun Cai, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Beijing Anzhen Hospital **Name:** Xin Du, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** Institute of Science and Technology for Brain-Inspired Intelligence **Name:** Craig S Anderson, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 4:** **Affiliation:** Beijing Anzhen Hospital **Name:** Chao Jiang, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: AnAg - Name: Antihypertensive Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4277 - Name: Antihypertensive Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427083 **Brief Title:** Registry Study to Determine the Effectiveness and Safety of Weight Loss With Enavogliflozin in Patients With Type 2 Diabetes Mellitus **Official Title:** An Anonymized, De-identified Registry Study to Determine the Effectiveness and Safety of Weight Loss With Enavogliflozin in Patients With Type 2 Diabetes Mellitus #### Organization Study ID Info **ID:** DW_ODNENV_DB_02 #### Organization **Class:** INDUSTRY **Full Name:** Daewoong Pharmaceutical Co. LTD. ### Status Module #### Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Daewoong Pharmaceutical 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 observational study is designed to assess the effects of Envlo Tablet or Envlomet SR Tablet on weight loss and safety in patients with Type 2 diabetes, conducted in real primary care settings over a period of 24 weeks. **Detailed Description:** The study plans to recruit patients with Type 2 diabetes who are scheduled to receive Envlo Tablet or Envlomet SR Tablet based on the attending physician's medical judgment, regardless of previous diabetes treatment. However, voluntary consent from patients is required for participation in the study, even if Envlo Tablet or Envlomet SR Tablet are prescribed. Data collection will occur for up to 24 weeks post-Envlo Tablet or Envlomet SR Tablet initiation, capturing demographic information, physical measurements, vital signs, and lifestyle factors. Follow-up visits at 12 weeks and 24 weeks post-baseline will be conducted to collect data, including clinical indicators, safety evaluations, and adverse events. Data will be collected based on routine clinical records, with no mandatory study-specific visits or interventions. Overall, this observational study aims to collect data on demographics, physical measurements, vital signs, and clinical indicators in patients receiving Envlo Tablet or Envlomet SR Tablet in real-world clinical settings, utilizing information obtained during routine patient care processes. ### Conditions Module **Conditions:** - Type 2 Diabetes Mellitus ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 240 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** patient diagnosed with type2 diabetes mellitus **Intervention Names:** - Drug: Envlo Tablet - Drug: Envolomet SR Tablet **Label:** patient diagnosed with type2 diabetes mellitus ### Interventions #### Intervention 1 **Arm Group Labels:** - patient diagnosed with type2 diabetes mellitus **Description:** Enavogliflozin 0.3mg **Name:** Envlo Tablet **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - patient diagnosed with type2 diabetes mellitus **Description:** Enavogliflozin 0.3mg/Metformin1,000mg **Name:** Envolomet SR Tablet **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** change in BMI at 24 weeks from baseline **Measure:** change in BMI **Time Frame:** 24 weeks **Description:** change in body weight at 24 weeks from baseline **Measure:** change in body weight **Time Frame:** 24 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Adults aged 19 to 80 years. 2. Patients with Type 2 diabetes who are scheduled to receive initial treatment with Enavogliflozin or Enavogliflozin Extended-Release Tablets based on the attending physician's medical judgment, within the following insurance coverage ranges: * Enavogliflozin monotherapy * Combination therapy of Enavogliflozin with two agents (metformin) * Combination therapy of Enavogliflozin with three agents (metformin + DPP-4 inhibitor) 3. Patients with obesity beyond the pre-obesity stage according to the 2022 Korean Endocrine Society obesity treatment guidelines: * Pre-obesity stage: BMI 23\~24.9 kg/m2 * Stage 1 obesity: BMI 25\~29.9 kg/m2 * Stage 2 obesity: BMI 30\~34.9 kg/m2 * Stage 3 obesity: BMI ≥ 35 kg/m2 4. Individuals planning to undertake appropriate exercise and dietary therapy for glycemic control during the observational study period. 5. Fertile women and men who agree to contraception according to appropriate contraceptive methods during the observational study period or have no plans for pregnancy, adhering to methods such as hormonal contraceptives, intrauterine devices or systems, tubal ligation, vasectomy, dual contraception methods (such as cervical cap and male condom), etc. 6. Individuals who have received detailed explanation and have understood the nature of the observational study and the investigational drug, and have provided written consent to participate voluntarily in the observational study and to comply with subject precautions during the study period. Exclusion Criteria: 1. Individuals with diabetes other than Type 2 diabetes (Type 1 diabetes, diabetic ketoacidosis, gestational diabetes, etc.). 2. Individuals contraindicated for Enavogliflozin or Enavogliflozin Extended-Release Tablets based on the approved indications: * Patients with a history of hypersensitivity reactions to the components of Enavogliflozin or Enavogliflozin Extended-Release Tablets * Patients with an eGFR (estimated Glomerular Filtration Rate) less than 30 mL/min/1.73m2, end-stage renal disease, or undergoing dialysis * Patients with moderate to severe hepatic impairment (AST or ALT \> 3 times the upper limit of normal, Total Bilirubin \> 2 times the upper limit of normal, hepatitis or hepatic failure) * Patients classified as NYHA (New York Heart Association) class III or IV 3. Patients initiating treatment with Enavogliflozin or Enavogliflozin Extended-Release Tablets at enrollment with an eGFR of less than 60 mL/min/1.73m2. 4. Patients with unstable weight due to treatment with obesity drugs or weight loss medications within 3 months prior to enrollment or other treatments (surgery, dietary therapy, etc.). 5. Individuals with diminished mental capacity. 6. Pregnant and lactating women. 7. Individuals currently participating in another clinical trial and receiving investigational drugs or investigational medical devices. 8. Other individuals deemed unsuitable for participation in the observational study based on the investigator's (attending physician's) judgment. **Maximum Age:** 80 Years **Minimum Age:** 19 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The mean and standard deviation of the change from baseline to 12 or 24 weeks in weight and body mass index (BMI) from previously conducted Phase 2 and Phase 3 clinical trials were used as references for calculation using G\*Power 3.1.9.7. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** NaRi Kim **Phone:** 82-10-6611-7051 **Role:** CONTACT ### 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 - ID: D000001836 - Term: Body Weight Changes - 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 - Abbrev: BC19 - Name: Gland and Hormone Related Diseases ### Condition Browse Module - Browse Leaves - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown - 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: M18102 - Name: Weight Loss - Relevance: HIGH - As Found: Weight Loss - 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 - ID: M5115 - Name: Body Weight Changes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003924 - Term: Diabetes Mellitus, Type 2 - ID: D000015431 - Term: Weight Loss ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11667 - Name: Metformin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427070 **Brief Title:** Effectiveness of Two Intracanal Irrigation Solutions **Official Title:** Effectiveness of Two Intracanal Irrigation Solutions Delivered Through Cryotherapy on Post-Endodontic Pain Relieve. A Randomized Clinical Trial #### Organization Study ID Info **ID:** CHX 2024 #### Organization **Class:** OTHER **Full Name:** Misr University for Science and Technology ### Status Module #### Completion Date **Date:** 2024-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-18 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-23 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-18 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Misr University for Science and Technology #### Responsible Party **Investigator Affiliation:** Misr University for Science and Technology **Investigator Full Name:** Manal Mohamed **Investigator Title:** Lecturer at Misr university **Type:** PRINCIPAL_INVESTIGATOR ### 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 aim of the present clinical trial is to investigate and compare the effect of crayotherapy utilizing two intra-canal final irrigating solutions on postoperative pain. **Detailed Description:** 1. st: Comparison of pain reduction algorism after cryotherapy using the two tested irrigating materials 2. nd. Number and frequency of analgesics taken for pain relief during one week postoperative ### Conditions Module **Conditions:** - Irreversible Pulpitis **Keywords:** - Pulpitis - CHX - Saline ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 1 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Group 1 sodium hypochlorite Group 2 saline Group 3 chlorohexidine **Intervention Names:** - Other: Irrigating solution **Label:** Irrigating solutions **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Irrigating solutions **Description:** Saline, sodium hypochlorite, chlorohexidine **Name:** Irrigating solution **Other Names:** - Chlorohexidine **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** pain scale Comparison of the 2 selected irrigating solutions **Measure:** pain scale **Time Frame:** 1 week **Description:** Frequency of analgesics for pain relief **Measure:** Analgesics Frequency **Time Frame:** 1 week ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Case diagnosed as having symptomatic irreversible pulpitis with symptomatic apical periodontitis * Patients requiring emergency RCT * Pre-operative pain score 7 on Numerical Rating (NRS) scale * Middle aged males (25-50) * Medical profile ASA1 * Willing to sign the consent form * Willing to answer our call for one week period Exclusion Criteria: * Females * Medical conditions above ASA1 * Multi-rooted teeth * Patients younger or older than (25-50) **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 25 Years **Sex:** MALE **Standard Ages:** - ADULT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003788 - Term: Dental Pulp Diseases - 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 - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M14525 - Name: Pulpitis - Relevance: HIGH - As Found: Pulpitis - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M6984 - Name: Dental Pulp Diseases - 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: D000011671 - Term: Pulpitis ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Antipy - Name: Antipyretics - Abbrev: Analg - Name: Analgesics - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M2340 - Name: Acetaminophen - Relevance: LOW - As Found: Unknown - ID: M15775 - Name: Sodium Hypochlorite - Relevance: LOW - As Found: Unknown - ID: M44557 - Name: Eusol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427057 **Brief Title:** A Study of Cadonilimab（AK104）Combined With Standard Treatment for Function Preservation in Urinary System Tumors **Official Title:** A Prospective, Open Label, Dual Cohort Study of Cadonilimab（AK104）Combined With Standard Treatment for Function Preservation in Urinary System Tumors #### Organization Study ID Info **ID:** TJ-IRB20240519 #### Organization **Class:** OTHER **Full Name:** Tongji Hospital ### Status Module #### Completion Date **Date:** 2027-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Tongji Hospital #### Responsible Party **Investigator Affiliation:** Tongji Hospital **Investigator Full Name:** Liu Huang **Investigator Title:** Clinical Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is an open label, dual cohort ,phase II study to explore efficacy and safety of cadonilimab(PD-1/CTLA-4 Bispecific Antibody) combined with standard regimen neoadjuvant treatment in urothelial carcinoma（UC） and renal cell carcinoma（RCC）, with evaluating successful preservation rate of bladder/kidney. **Detailed Description:** UC and RCC confirmed by histopathology or cytology prior have not received systematic treatment, who had indications for surgical resection and were difficult to preserve organ function after surgery or were partially resection but the patients have a strong desire to preserve organ function. This study enrolled 20 cases in each cohort of UC and RCC，pts received neoadjuvant treatment containing cadonilimab for no more than 6 cycles. ### Conditions Module **Conditions:** - Urinary System Tumor **Keywords:** - UC，RCC，immunotherapy, neoadjuvant ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will receive AK104 (10mg/kg ,Q3W，intravenously) plus standard regimen （gemcitabine or albumin paclitaxel) neoadjuvant treatment with no more than 6 cycles. **Intervention Names:** - Drug: Cadonilimab plus chemotherapy **Label:** UC **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients will receive AK104 (10mg/kg ,Q3W，intravenously) plus standard regimen （TKI，e.g. sunitinib, pezopanib) neoadjuvant treatment with no more than 6 cycles. **Intervention Names:** - Drug: Cadonilimab plus TKI **Label:** RCC **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - UC **Description:** AK104 (10mg/kg ,Q3W，intravenously) plus chemotherapy（e.g. gemcitabine or albumin paclitaxel，dosage based on guidelines or instructions） **Name:** Cadonilimab plus chemotherapy **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - RCC **Description:** Patients will receive AK104 (10mg/kg ,Q3W，intravenously) plus TKI（e.g. sunitinib, pezopanib，dosage based on guidelines or instructions) **Name:** Cadonilimab plus TKI **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Evaluating the impact of neoadjuvant therapy on organ preservation function **Measure:** Bladder/Kidney Preservation rate **Time Frame:** Up to approximately 18 Weeks (Time of surgery) #### Secondary Outcomes **Description:** percentage of participants with a complete response (CR) or partial response (PR) **Measure:** Objective Response Rate (ORR) **Time Frame:** Up to approximately 18 Weeks **Description:** No residual tumor (ypT0N0) and partial response (ypTis-1N0) in surgical specimen. **Measure:** Rate of Pathologic Response **Time Frame:** Up to approximately 18 Weeks (Time of surgery) ] **Description:** Overall survival is defined as the time from enrollment to death due to any cause. **Measure:** Overall Survival (OS) **Time Frame:** Up to approximately 36 Months **Description:** Assess adverse events according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 **Measure:** Assess Adverse Events **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Voluntary agreement to provide written informed consent. * Male or female, Age ≥ 18 years. * Predicted survival ≥ 12 weeks. * Histologically confirmed diagnosis of urothelial carcinoma（UC） and renal cell carcinoma（RCC）. * Prior no antitumor systematic treatment . * Have clinically non-metastatic high risk urothelial carcinoma (cT2-T4a, N0-3, M0) . * High risk renal cell carcinoma (≥ T2Nx or TanyN+)，include subjects with only Oligotransfer. * Willing to undergo surgical resection and were difficult to preserve organ function after surgery or were partially resection but the patients have a strong desire to preserve organ function. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Adequate organ function, evidenced by the following laboratory results within 7 days prior to the study treatment. * Male and female participants are eligible to participate if they agree to the contraception use as per study protocol. * Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol. Exclusion Criteria: * Has received other antitumor therapy before planned start of trial treatment. * History of major surgery within 4 weeks of planned start of trial treatment. * Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive, or HIVAb positive. * Has received a live virus vaccine within 4 weeks of planned start of trial treatment. * NYHA Class III heart failure. * Suffering from active infection requiring systemic treatment. * Uncontrolled hypertension, diabetes, Interstitial lung Disease, or COPD; * Treated with systemic treatment (e.g. immunomodulators, corticosteroids or immunosuppressants) for the autoimmune disease within 2 years prior to the study treatment. * History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. * Pregnancy or lactation. * Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Liu Huang, Clinical Professor **Phone:** 63639656 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Tongji Hospital , Wuhan, Hubei Province, China, 430030 **Name:** Liu Huang, Clinical Professor **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Tongji Hospital , Wuhan, Hubei Province, China, 430030 **Name:** Xiao Yu, Clinical Professor **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - 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: D000014570 - Term: Urologic 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: M17320 - Name: Urologic Neoplasms - Relevance: HIGH - As Found: Urinary System Tumors - 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: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014571 - Term: Urologic Neoplasms ### 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: LOW - As Found: Unknown - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M2985 - Name: Gemcitabine - Relevance: LOW - As Found: Unknown - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: M1698 - Name: Sunitinib - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427044 **Brief Title:** Effect of Bupivacaine Liposome Anterior Serratus Deep Block on Chronic Pain After Breast Cancer Surgery: a Randomized Controlled Study **Official Title:** Effect of Bupivacaine Liposome Anterior Serratus Deep Block on Chronic Pain After Breast Cancer Surgery: a Randomized Controlled Study #### Organization Study ID Info **ID:** TJ-IRB202403018 #### Organization **Class:** OTHER **Full Name:** Tongji Hospital ### Status Module #### Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-25 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Lu Hua #### Responsible Party **Investigator Affiliation:** Tongji Hospital **Investigator Full Name:** Lu Hua **Investigator Title:** Assistant Professor **Type:** SPONSOR_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 the effect and influence of liposome bupivacaine anterior serrat plane block on postoperative chronic pain in breast cancer patients, evaluate the therapeutic effect of liposome bupivacaine in postoperative chronic pain, and provide a new method for patients with postoperative chronic pain. ### Conditions Module **Conditions:** - Breast Cancer Patients With Chronic Pain After Surgery ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 143 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Bupivacaine lipid 20mL (20mL 266mg bupivacaine liposomes) was ultrasound-guided for a single anterior serranus plane block **Intervention Names:** - Drug: Anterior serratus block group **Label:** Anterior serratus block group **Type:** EXPERIMENTAL #### Arm Group 2 **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Anterior serratus block group **Description:** Bupivacaine lipid 20mL (20mL 266mg bupivacaine liposomes) was ultrasound-guided for a single anterior serranus plane block **Name:** Anterior serratus block group **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Pain levels were measured three months after surgery **Measure:** Incidence of chronic pain 3 months after surgery **Time Frame:** Three months after surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult patients (aged ≥18 years) who are scheduled to undergo unilateral modified radical breast cancer surgery Exclusion Criteria: * 1. Patients with coagulation dysfunction 2. There are infected patients at the puncture site 3. For patients allergic to any trial drug 4. Patients who take painkillers within 48 hours before surgery 5. Severe cardiopulmonary insufficiency, such as EF\< 40%, FEVC \< 50% expected; Uncontrolled hypertension; 6. Refuse to perform nerve block puncture 7. Mental disorders, epilepsy history; 8. Unable to give informed consent or are participating in other clinical trials. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Wuhan **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** LU HUA, 1 - **Phone:** +8618971287754 - **Role:** CONTACT **Country:** China **Facility:** Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology **State:** Hubei **Zip:** 430000 ### IPD Sharing Statement Module **IPD Sharing:** NO ## 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: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### 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 - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M29442 - Name: Chronic Pain - Relevance: HIGH - As Found: Chronic Pain - ID: M13066 - Name: Pain - 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: 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: D000001943 - Term: Breast Neoplasms - ID: D000059350 - Term: Chronic Pain ### 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: M5315 - Name: Bupivacaine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427031 **Brief Title:** Comparing Efficacy and Safety of TJO-083 in Dry Eye Diseases Patients **Official Title:** A Multi-center, Randomized, Double-blinded, Active Control, Parallel, Phase 3 Trial to Evaluate the Efficacy and Safety of TJO-083 in Dry Eye Diseases Patients #### Organization Study ID Info **ID:** TJO-083-A03 #### Organization **Class:** INDUSTRY **Full Name:** Taejoon Pharmaceutical Co., Ltd. ### Status Module #### Completion Date **Date:** 2025-03-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-07-14 **Type:** ACTUAL **Status Verified Date:** 2023-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Taejoon Pharmaceutical 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:** In patients with dry eye syndrome, the test drug(TJO-083) or the control drug is administered for 12 weeks, and the corneal staining of each group would be evaluated. The purpose of this clinical Study is to demonstrate that the test drug is not clinically inferior to the control drug. ### Conditions Module **Conditions:** - Dry Eye - Dry Eye Syndromes ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** A Multicenter, Randomized, Double-blind, Active control for Evaluating the Efficacy and Safety of the test drug(TJO-083) Compared with the control drug in Dry Eye Sydrome ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 288 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** TJO-083 : 1 drop 3 times a day **Intervention Names:** - Drug: TJO-083 **Label:** TJO-083 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 1 drop 6 times a day **Intervention Names:** - Drug: Diquafosol ophthalmic sodium solution 3% **Label:** Diquas-s Ophthalmic solution 3% 0.4mL **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - TJO-083 **Description:** Diquafosol ophthalmic sodium solution, 1 drop 3 times a day **Name:** TJO-083 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Diquas-s Ophthalmic solution 3% 0.4mL **Description:** Diquafosol ophthalmic sodium solution, 1 drop 6 times a day **Name:** Diquafosol ophthalmic sodium solution 3% **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Change from Baseline in corneal staining using blue fluorescein staining procedure at Week 4. **Measure:** Change From Baseline in Corneal Staining at Week 4 **Time Frame:** Baseline and Week 4 #### Secondary Outcomes **Description:** Change from Baseline in corneal staining using blue fluorescein staining procedure at Week 8, 12. **Measure:** Change From Baseline in Corneal Staining at Week 8, 12 **Time Frame:** Baseline and Week 8 and 12 **Description:** Change From Baseline in Conjunctival Staining using Rose Bengal staining procedure at Week 4, 8 and 12 **Measure:** Change From Baseline in Conjunctival Staining at Week 4, 8 and 12 **Time Frame:** Baseline and Week 4, 8 and 12 **Description:** The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. **Measure:** Change From Baseline in Non-anesthetic Schirmer Test at Week 4, 8, 12 **Time Frame:** Baseline and Week 4, 8 and 12 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or female, age 20 or over * Has dry eye symptoms (minimum 3 months) * Screening both eyes, the corrected visual acuity is 0.2 or more * Written informed consent to participate in the trial Exclusion Criteria: * The patients who treated with topical NSAIDs/hyaluronate sodium ophthalmic solutions within 2 weeks of randomized visits. * The patients with systemic or ocular disorders affecting the test results(ocular surgery, trauma, or disease) within 2 months of screening visits. * Intraocular pressure(IOP)\> 21 mmHg * Patients with contact lens **Healthy Volunteers:** True **Maximum Age:** 80 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Sukyoung Kwon, MPH., PhD **Phone:** +82-799-0175 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** HyungKeun Lee, MD **Phone:** +82-02-2019-3444 **Role:** CONTACT #### Locations **Location 1:** **City:** Seoul **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Sukyoung Kwon - **Phone:** 82)-2-799-0175 - **Role:** CONTACT **Country:** Korea, Republic of **Facility:** Taejoon Pharmaceutical Co., Ltd. **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007766 - Term: Lacrimal Apparatus Diseases - ID: D000007637 - Term: Keratoconjunctivitis - ID: D000003231 - Term: Conjunctivitis - ID: D000003229 - Term: Conjunctival Diseases - ID: D000007634 - Term: Keratitis - ID: D000003316 - Term: Corneal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC11 - Name: Eye Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M18040 - Name: Dry Eye Syndromes - Relevance: HIGH - As Found: Dry Eye - ID: M10664 - Name: Keratoconjunctivitis Sicca - Relevance: HIGH - As Found: Dry Eye - ID: M8271 - Name: Eye Diseases - Relevance: HIGH - As Found: Eye Disease - ID: M10663 - Name: Keratoconjunctivitis - Relevance: LOW - As Found: Unknown - ID: M10786 - Name: Lacrimal Apparatus Diseases - Relevance: LOW - As Found: Unknown - ID: M6455 - Name: Conjunctivitis - Relevance: LOW - As Found: Unknown - ID: M6453 - Name: Conjunctival Diseases - Relevance: LOW - As Found: Unknown - ID: M10660 - Name: Keratitis - Relevance: LOW - As Found: Unknown - ID: M6539 - Name: Corneal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015352 - Term: Dry Eye Syndromes - ID: D000007638 - Term: Keratoconjunctivitis Sicca - ID: D000005128 - Term: Eye Diseases ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M12814 - Name: Ophthalmic Solutions - Relevance: LOW - As Found: Unknown - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427018 **Brief Title:** Expressions of Ezrin and Pip5k1α Proteins in Airway Smooth Muscle of Asthmatic Patients **Official Title:** Assessing the Expressions of Ezrin, Phosphorylated Ezrin, and Pip5k1α in the Airway Smooth Muscle of Asthmatic Patient #### Organization Study ID Info **ID:** ShanghaiUTCM-0512 #### Organization **Class:** OTHER **Full Name:** Shanghai University of Traditional Chinese Medicine ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-28 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Yueyang Hospital of Integrated Traditional Chinese and Western Medicine **Class:** OTHER **Name:** Shanghai 6th People's Hospital **Class:** OTHER **Name:** Xiangya Hospital of Central South University **Class:** UNKNOWN **Name:** Baoshan Hospital, Shanghai University of Traditional Chinese Medicine #### Lead Sponsor **Class:** OTHER **Name:** Lei-Miao Yin #### Responsible Party **Investigator Affiliation:** Shanghai University of Traditional Chinese Medicine **Investigator Full Name:** Lei-Miao Yin **Investigator Title:** Prof. **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Asthma, a prevalent chronic respiratory affliction, significantly impinges upon the quality of life for affected individuals. Timely and appropriate diagnostic measures, coupled with efficacious therapeutic interventions, are paramount in mitigating exacerbations of symptoms and enhancing the life quality of patients. Ezrin plays an important role in maintaining cell morphology, cell migration, cell adhesion and polarisation, but Ezrin expression in airway smooth muscle remains unclear. Pip5k1α is an important kinase involved in intracellular phosphatidylinositol signalling pathways that may be involved in smooth muscle contraction and diastole. Therefore, further studies are necessary to elucidate the changes of Ezrin and Pip5k1α in patients with asthma to provide a basis for investigating alternative treatments for asthma. **Detailed Description:** Asthma is a complex and heterogeneous disease with a combination of genetic and environmental multifactors, which is mainly characterised by recurrent episodes of wheezing, shortness of breath, chest tightness and cough. The nature of the pathology manifests itself as a chronic inflammatory disease with abnormal antigen presentation and T-cell activation, and an imbalance of Th1/Th2 cells leading to dysfunction of airway smooth muscle cells. There is a lack of safe and effective medications against asthma for current treatment. For example, although glucocorticosteroids are the first-line drugs for asthma, only 12% of patients are able to use them in accordance with medical advice. β2 agonists are often used in combination with hormones, but up to 55% of asthmatics still fail to get effective control of their symptoms. Therefore, the development of innovative drugs with new targets and mechanisms has become the trend of asthma drug development at home and abroad. The discovery of new asthma targets will help to elucidate the asthma mechanism and solve a series of problems in clinical treatment. Ezrin is one of the major members of the Ezrin-Radixin-Moesin (ERM) family, which plays an important role in the maintenance of cell morphology, cell migration, cell adhesion and polarisation. Pip5k1α is an important kinase involved in the intracellular phosphatidylinositol signaling pathway, which may be associated with the smooth muscle contraction and diastole related. In a previous study, single-cell sequencing of lung tissue from asthmatic mice revealed that Ezrin and Pip5k1α were significantly increased in asthmatic airway smooth muscle cells. In vitro cellular experiments suggested that Ezrin and Pip5k1α inhibition could inhibit airway smooth muscle cell contraction, suggesting that inhibitors of both may provide a therapeutic advantage for reducing lung resistance in asthma. Therefore, further studies to elucidate the changes of Ezrin and Pip5k1α in asthma patients are warranted to provide a basis for the use of inhibitors of both as an alternative treatment for asthma. ### Conditions Module **Conditions:** - Asthma - Protein **Keywords:** - Asthma - Ezrin - Pip5k1α - Airway smooth muscle ### Design Module #### Bio Spec **Description:** Tissue **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** No intervention. **Intervention Names:** - Other: No intervention. **Label:** Asthma group #### Arm Group 2 **Description:** No intervention. **Intervention Names:** - Other: No intervention. **Label:** Non-asthma group ### Interventions #### Intervention 1 **Arm Group Labels:** - Asthma group - Non-asthma group **Description:** Observational study with no intervention. **Name:** No intervention. **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** IF **Measure:** Immunofluorescence results **Time Frame:** 6 months **Description:** IHC **Measure:** Immunohistochemistry results **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Lung tissue samples; * The samples come from patients aged 18-70 years old, regardless of gender, who underwent lung tissue sampling for surgical indications during treatment; * Paraffin sections of lung tissue from patients diagnosed with bronchial asthma, including tracheal smooth muscle; * Paraffin sections of lung tissue from non-asthma patients, including tracheal smooth muscle. Exclusion Criteria: * Paraffin sections of lung tissue from patients who have been diagnosed with COPD; * Other situations where the researcher deems it inappropriate to participate in this study. **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Referring to previous validation studies of target proteins in the literature, the sample size required for this validation experiment is related to multiple factors: (1) Selection of genes: mRNA differentially expressed genes will have a 50% probability of differential protein expression. (2) Antibody selection: Commercially available antibodies will be used for immunohistochemical detection of formalin-fixed, paraffin-embedded tissues with a success rate of up to 75%. According to previous validation studies of the target protein, the required samples are 30 in each group, for a total of 60 samples. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Lei-Miao Yin, MD **Phone:** 86 21 54592134 **Role:** CONTACT #### Locations **Location 1:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Lei-Miao Yin, MD - **Phone:** 86-21-54592134 - **Role:** CONTACT **Country:** China **Facility:** Yueyang Hospital, Shanghai University of Traditional Chinese Medicine **State:** Shanghai **Status:** RECRUITING **Zip:** 200030 #### Overall Officials **Official 1:** **Affiliation:** Yueyang Hospital, Shanghai University of Traditional Chinese medicine **Name:** Lei-Miao Yin, MD **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Shanghai 6th People's Hospital **Name:** Wei-Wei He, MD **Role:** STUDY_DIRECTOR **Official 3:** **Affiliation:** Xiangya Hospital of Central South University **Name:** Jun-Tao Feng, MD **Role:** STUDY_DIRECTOR **Official 4:** **Affiliation:** Baoshan Hospital, Shanghai University of Traditional Chinese Medicine **Name:** Li Li, MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** It is not yet known if there will be a plan to make IPD available. **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001982 - Term: Bronchial Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000008171 - Term: Lung Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4556 - Name: Asthma - Relevance: HIGH - As Found: Asthma - ID: M5258 - Name: Bronchial Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001249 - Term: Asthma ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427005 **Brief Title:** Fruquintinib Plus S-1 and Raltitrexed (RSF) for mCRC **Official Title:** Fruquintinib Combined With S-1 and Raltitrexed for Patients With Metastatic Colorectal Cancer Refractory to Standard Therapies: A Phase II Study #### Organization Study ID Info **ID:** 2023-71 #### Organization **Class:** OTHER **Full Name:** West China Hospital ### Status Module #### Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-18 **Type:** ESTIMATED #### Start Date **Date:** 2023-02-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** West China Hospital #### Responsible Party **Investigator Affiliation:** West China Hospital **Investigator Full Name:** Meng Qiu **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Based on the FRECO-2 study, Fruquintinib has become one of the standard third-line treatments for advanced colorectal cancer; however, its objective response rate (ORR) remains low. Our previous studies have shown that the combination of raltitrexed and S-1 -/+ bevacizumab is effective and provides a significant survival benefit in patients with metastatic colorectal cancer (mCRC) who are refractory to standard treatments. This study aims to evaluate the efficacy and safety of combining Fruquintinib with S-1 and raltitrexed in these patients. **Detailed Description:** Conducted at West China Hospital in China, this investigator-initiated, open-label, single-arm, phase II trial included patients with mCRC that had progressed following treatment with fluoropyrimidine, irinotecan, and oxaliplatin, and had at least one measurable lesion. Patients could have previously received anti-EGFR (for tumors with wild-type RAS) and anti-VEGF therapy in the first or second line, including those who had been treated with bevacizumab in two consecutive chemotherapy regimens. Participants received Fruquintinib (5 mg daily for 14 days followed by a 7-day break), oral S-1 (80-120 mg daily for 14 days, followed by a 7-day break), and raltitrexed (3 mg/m² on day 1, with a maximum dose of 5 mg) every 3 weeks. The primary endpoint was the ORR, while secondary endpoints included progression-free survival (PFS), overall survival (OS), and toxicity. ### Conditions Module **Conditions:** - Fruquintinib - S-1 - Raltitrexed **Keywords:** - S-1 - Fruquintinib - raltitrexed ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Participants received Fruquintinib (5 mg daily for 14 days followed by a 7-day break), oral S-1 (80-120 mg daily for 14 days, followed by a 7-day break), and raltitrexed (3 mg/m² on day 1, with a maximum dose of 5 mg) every 3 weeks. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 66 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants received Fruquintinib (5 mg daily for 14 days followed by a 7-day break), oral S-1 (80-120 mg daily for 14 days, followed by a 7-day break), and raltitrexed (3 mg/m² on day 1, with a maximum dose of 5 mg) every 3 weeks. **Intervention Names:** - Drug: Fruquintinib - Drug: S-1 - Drug: raltitrexed **Label:** RSF treatment arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - RSF treatment arm **Description:** Fruquintinib 5 mg daily for 14 days followed by a 7-day break **Name:** Fruquintinib **Other Names:** - Elunate **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - RSF treatment arm **Description:** S-1 80-120 mg daily for 14 days, followed by a 7-day break **Name:** S-1 **Other Names:** - Tegafur,Gimeracil and Oteracil Potassium Capsules **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - RSF treatment arm **Description:** raltitrexed 3 mg/m² on day 1, with a maximum dose of 5 mg **Name:** raltitrexed **Other Names:** - thymidylate synthase inhibitor **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Objective Response Rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1 **Measure:** ORR **Time Frame:** about a year #### Secondary Outcomes **Description:** Disease Control Rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1 **Measure:** DCR **Time Frame:** about a year **Description:** OS is the time interval from the start of treatment to death due to any reason or lost of follow-up **Measure:** OS **Time Frame:** about a year **Description:** Version 5.0 and AEs leading to dose interruption or discontinuation. **Measure:** Safety and tolerability **Time Frame:** about a year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age ≥ 18 years, any gender. 2. Patients with metastatic colorectal adenocarcinoma confirmed by pathological histology or cytology. 3. Expected survival time ≥ 12 weeks. 4. ECOG score of 0-2. 5. Previously treated for metastatic colorectal cancer with fluoropyrimidine (allowing intravenous and/or oral fluoropyrimidine formulations, excluding DPD enzyme inhibitors), irinotecan, and oxaliplatin chemotherapy, which failed (treatment failure defined as intolerable adverse reactions, disease progression during treatment, or disease progression within 6 months after completing adjuvant chemotherapy); regardless of prior use of targeted drugs such as cetuximab or bevacizumab. 6. Patients must have an interval of at least 2 weeks since the last chemotherapy (at least 1 week for oral chemotherapy drugs) or more than 4 weeks since the end of radiotherapy, with the study's observable lesions located outside the radiotherapy target area. 7. According to RECIST 1.1 criteria, at least one measurable tumor lesion with a maximum diameter ≥ 1 cm as determined by spiral CT scan. 8. Laboratory test results within 1 week before enrollment must meet the following criteria: 1. Hemoglobin ≥ 90 g/L; Platelets (PLT) ≥ 75 × 10\^9/L; 2. White blood cells (WBC) ≥ 3.0 × 10\^9/L; Neutrophils (ANC) ≥ 1.5 × 10\^9/L; 3. Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); 4. Total bilirubin (TBI) ≤ 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN if there is liver metastasis). 9. No prior use of raltitrexed or S-1 (or DPD enzyme inhibitors) in the treatment of colorectal cancer. 10. Signed informed consent. Exclusion Criteria: 1. Patients unable to take oral medications. 2. Patients who have previously been treated with small molecule TKI drugs. 3. Patients with severe hepatic or renal insufficiency, or a recent history of myocardial infarction (within 3 months). 4. Patients with a history of other malignancies within the past five years, except for cured cervical carcinoma in situ and basal cell carcinoma of the skin. 5. Patients with a history of inflammatory bowel disease or extensive colonic resection, ≥50% or extensive small bowel resection with chronic diarrhea, or intestinal obstruction. 6. Patients with severe uncontrolled internal medical conditions or acute infections (fever \> 38°C due to infection). 7. Patients with symptomatic brain or leptomeningeal metastases (unless the patient has been treated for brain or leptomeningeal metastases \> 6 months, with negative imaging results within 4 weeks before study entry, and has stable clinical symptoms related to brain or leptomeningeal metastases at study entry). 8. Patients with clinically significant, uncontrolled pleural effusion or ascites despite clinical intervention. 9. Pregnant or breastfeeding women, or patients of reproductive potential (males or females not in menopause for less than 1 year) unwilling to use contraception. 10. Patients known to be allergic to raltitrexed, S-1, and Fruquintinib or any of their components. 11. Patients deemed unsuitable for participation in this clinical trial by the investigator. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Meng Qiu, MD. **Phone:** +8618980921776 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Weibing C Leng, PhD. **Phone:** +8618980921763 **Role:** CONTACT #### Locations **Location 1:** **City:** Chengdu **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Weibing Leng, Ph.D - **Phone:** +8618980921763 - **Role:** CONTACT **Country:** China **Facility:** Sichuan University West China Hospital **State:** Sichuan **Status:** RECRUITING **Zip:** 610044 **Location 2:** **City:** Chengdu **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Meng Qiu, MD - **Phone:** 028-85423203 - **Role:** CONTACT **Country:** China **Facility:** West China Hospital, Sichuan University **State:** Sichuan **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Sichuan University **Name:** Meng Qiu, MD. **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### 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: D000005493 - Term: Folic Acid Antagonists - ID: D000004791 - Term: Enzyme Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Micro - Name: Micronutrients - Abbrev: Hemat - Name: Hematinics - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M252094 - Name: Raltitrexed - Relevance: HIGH - As Found: Acrylic - ID: M8760 - Name: Tegafur - Relevance: HIGH - As Found: Nail - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown - ID: M17546 - Name: Vitamin B Complex - Relevance: LOW - As Found: Unknown - ID: M8618 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: M8619 - Name: Folic Acid Antagonists - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: T447 - Name: Folinic Acid - Relevance: LOW - As Found: Unknown - ID: T446 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: T448 - Name: Folate - Relevance: LOW - As Found: Unknown - ID: T475 - Name: Vitamin B9 - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000005641 - Term: Tegafur - ID: C000068874 - Term: Raltitrexed ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426992 **Brief Title:** Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Hepatic Malignancies **Official Title:** Evaluation of Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Small Liver Malignancies: A Prospective Single Center Study #### Organization Study ID Info **ID:** 2402-111-151 #### Organization **Class:** OTHER **Full Name:** Seoul National University Hospital ### Status Module #### Completion Date **Date:** 2026-03-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-03-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-30 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Seoul National University Hospital #### Responsible Party **Investigator Affiliation:** Seoul National University Hospital **Investigator Full Name:** Jeong Min Lee **Investigator Title:** Professor **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 is to determine the technical success rate of creating a safety margin of 5 mm or more including the tumor by performing image-guided percutaneous microwave thermal therapy using a microwave generator and antenna developed by StarMed for the treatment of small liver cancer and the 1-year local recurrence rate based on follow-up imaging tests. ### Conditions Module **Conditions:** - Liver Malignant Tumors ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 62 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Following the existing procedure of our institute, we aim to treat the tumor by applying up to 150W of microwaves within the tumor using a StarWave microwave generator and a 13-gauge antenna under fusion ultrasound guidance. If necessary, the antenna is reinserted 1-2 times to create sufficient ablation lesions until an echogenic band of 5-10mm is formed around the tumor and its periphery, implementing overlapping microwave ablation (MWA). Afterward, the antenna is removed while applying microwave energy to prevent bleeding. **Intervention Names:** - Procedure: Microwave ablation **Label:** Patients with malignant liver tumors **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients with malignant liver tumors **Description:** Following the existing procedure of our institute, we aim to treat the tumor by applying up to 150W of microwaves within the tumor using a StarWave microwave generator and a 13-gauge antenna under fusion ultrasound guidance. If necessary, the antenna is reinserted 1-2 times to create sufficient ablation lesions until an echogenic band of 5-10mm is formed around the tumor and its periphery, implementing overlapping microwave ablation (MWA). Afterward, the antenna is removed while applying microwave energy to prevent bleeding. **Name:** Microwave ablation **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Technical success addresses whether the index tumor was treated according to a predefined protocol and entirely covered by the ablation zone. **Measure:** Technical success **Time Frame:** Immediately after ablation **Description:** Local tumor progression, defined as the appearance of tumor foci at the margin of the ablation zone after the attainment of treatment success **Measure:** Local tumor progression rate **Time Frame:** 12 months after ablation #### Secondary Outcomes **Description:** Post ablation complications were defined as problems noted within 1 month after MWA as well as additional complications identified on follow-up imaging and judged to be likely caused by ablation. **Measure:** Complication after ablation **Time Frame:** Immediately, 1 month, 3 months, 6 months, 9 months, and 12 months after radiofrequency ablation **Description:** Recurrence-free survival was defined as the interval between ablation and the date of any type of recurrence or the last follow-up date if there was no recurrence. **Measure:** Recurrence-free survival **Time Frame:** 12 months after ablation ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Child-Pugh Class A or B * Patients with suspected hepatocellular carcinoma or residual/recurrent hepatocellular carcinoma of 4 cm or less on MDCT, CEUS, or MRI performed within the last 60 days or Patients with suspected metastatic liver cancer of 4 cm or less on MDCT, CEUS, or MRI performed within the last 60 days, for whom microwave thermal ablation is being considered Exclusion Criteria: * In cases where there are three or more malignant liver tumors * When the maximum size of the tumor exceeds 4 cm * Diffuse infiltrative type of cancer with unclear tumor boundaries * When the tumor is adhered to the central hepatic portal vein, hepatic vein, or bile duct by 5 mm or more * Severe liver failure (Child-Pugh Class C) * In cases of vascular invasion by malignant liver tumors * Severe coagulopathy (platelet count below 50,000/mm³ or INR prolonged by more than 50%) * In cases of multiple extrahepatic metastases * Situations where it is highly unlikely to obtain appropriate data for research purposes **Maximum Age:** 85 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Hyun Hee Lee **Phone:** 82-2-2072-4177 **Role:** CONTACT #### Locations **Location 1:** **City:** Seoul **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Hyun Hee Lee - **Phone:** 82-2-2072-4177 - **Role:** CONTACT ***Contact 2:*** - **Name:** Jeong Min Lee, MD, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Korea, Republic of **Facility:** Seoul National University Hospital **Status:** RECRUITING ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009369 - Term: Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000004066 - Term: Digestive System Diseases - ID: D000008107 - Term: Liver 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: M11113 - Name: Liver Neoplasms - Relevance: HIGH - As Found: Liver Malignant Tumors - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008113 - Term: Liver Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: Hemat - Name: Hematinics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426979 **Brief Title:** Sequential Letrozole and Methotrexate Therapy Role in Treatment of Tubal Ectopic Pregnancy **Official Title:** Sequential Letrozole and Methotrexate Therapy Safely Improved the Outcomes of Medical Treatment of Tubal Ectopic Pregnancy #### Organization Study ID Info **ID:** ZU-IRB#254 24/3-2024 #### Organization **Class:** OTHER_GOV **Full Name:** Zagazig University ### Status Module #### Completion Date **Date:** 2024-01-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-06-01 **Type:** ACTUAL #### Start Date **Date:** 2023-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Zagazig University #### Responsible Party **Investigator Affiliation:** Zagazig University **Investigator Full Name:** Walid Mohamed Elnagar **Investigator Title:** Assistant professor of Gynecology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Ectopic pregnancy (EP) is a common condition involving the implantation of fertilized ovum outside the uterine cavity, accounting for 1-2% of all pregnancies. Tubal EP (TEP) is the most common and poses a significant risk to maternal life. Early diagnosis and medical treatment, such as methotrexate (MTX) and the Fallopian tube (FT), have been studied. However, the efficacy of single-dose methotrexate (SD-MTX) is questionable, and the efficacy of two-dose versus SD-MTX for medical management of EP is being evaluated. High estrogens/progesterone ratios can disrupt embryonic motility and lead to TEP. ### Conditions Module **Conditions:** - Pregnancy Tubal ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Masking Description:** Patients were divided into 2 Groups as the group titles were printed into cards that were enclosed in sealed envelopes and patients were asked to choose a closed envelop. **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 200 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Letrozole and Methotrexate Therapy's Group **Intervention Names:** - Drug: Methotrexate - Drug: Letrozole **Label:** Group LTZ-MTX **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Methotrexate Therapy's Group **Intervention Names:** - Drug: Methotrexate **Label:** Group MTX **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group LTZ-MTX - Group MTX **Description:** Methotrexate 25 mg/ml was given as single-dose of intramuscular (IM) injection in a dose of 50 mg/m2. **Name:** Methotrexate **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Group LTZ-MTX **Description:** FEMARA 2.5 mg tablets two tablets daily **Name:** Letrozole **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Role of Letrozole in resolution of Tubal Ectopic Pregnancy (TEP) that was confirmed by TVU and without shifting to surgery. **Measure:** The Rate of resolution of Tubal Ectopic Pregnancy (TEP) **Time Frame:** 9 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Presence of gestational masses of \<3.5 cm in its greatest diameter in an intact uterine tube and showed no fetal cardiac activity; * Absence of hemodynamic manifestations or evidence of intra-peritoneal bleeding on TVU and pre-treatment serum hCG of \<3500 IU/L. Exclusion Criteria: * Free of Inclusion Criteria **Maximum Age:** 60 Years **Minimum Age:** 22 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Zagazig **Country:** Egypt **Facility:** Zagazig university **State:** Ash Sharqia Governorate **Zip:** 44519 ## 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 ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14147 - Name: Pregnancy, Ectopic - Relevance: HIGH - As Found: Ectopic Pregnancy - ID: M14150 - Name: Pregnancy, Tubal - Relevance: HIGH - As Found: Tubal Ectopic Pregnancy - ID: M8260 - Name: Cardiac Complexes, Premature - 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 - ID: T2035 - Name: Ectopic Pregnancy - Relevance: HIGH - As Found: Ectopic Pregnancy ### Condition Browse Module - Meshes - ID: D000011271 - Term: Pregnancy, Ectopic - ID: D000011274 - Term: Pregnancy, Tubal ### Intervention Browse Module - Ancestors - ID: D000000020 - Term: Abortifacient Agents, Nonsteroidal - ID: D000000019 - Term: Abortifacient Agents - ID: D000012102 - Term: Reproductive Control Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents - ID: D000003879 - Term: Dermatologic Agents - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000005493 - Term: Folic Acid Antagonists - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000018501 - Term: Antirheumatic Agents - ID: D000019384 - Term: Nucleic Acid Synthesis Inhibitors - ID: D000047072 - Term: Aromatase Inhibitors - ID: D000065088 - Term: Steroid Synthesis Inhibitors - ID: D000004965 - Term: Estrogen Antagonists - ID: D000006727 - Term: Hormone Antagonists - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Micro - Name: Micronutrients - Abbrev: Hemat - Name: Hematinics - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M11703 - Name: Methotrexate - Relevance: HIGH - As Found: Breast Cancer - ID: M1743 - Name: Letrozole - Relevance: HIGH - As Found: Cross- - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown - ID: M7074 - Name: Dermatologic Agents - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M17546 - Name: Vitamin B Complex - Relevance: LOW - As Found: Unknown - ID: M8618 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: M8619 - Name: Folic Acid Antagonists - 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: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: M25769 - Name: Aromatase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M8116 - Name: Estrogens - Relevance: LOW - As Found: Unknown - ID: M8114 - Name: Estrogen Antagonists - Relevance: LOW - As Found: Unknown - ID: M30483 - Name: Estrogen Receptor Antagonists - 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: T447 - Name: Folinic Acid - Relevance: LOW - As Found: Unknown - ID: T446 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: T448 - Name: Folate - Relevance: LOW - As Found: Unknown - ID: T475 - Name: Vitamin B9 - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000008727 - Term: Methotrexate - ID: D000077289 - Term: Letrozole ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426966 **Acronym:** GS VS BBR A **Brief Title:** Gymnema Sylvestre vs Berberine in Obesity Gene Expression of Adipokines **Official Title:** Comparative Efficacy of Gymnema Sylvestre vs Berberine in the Clinical Outcomes and Gene Expression of Adipokines in Patients With Exogenous Obesity #### Organization Study ID Info **ID:** ESM.CE-01/7-12-2015 #### Organization **Class:** OTHER **Full Name:** National Polytechnic Institute, Mexico #### Secondary ID Infos **Domain:** Instituto Politécnico Nacional México **ID:** 20170253 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2017-02-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-18 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-02-01 **Type:** ACTUAL #### Start Date **Date:** 2016-02-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-18 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Instituto Nacional de Pediatria #### Lead Sponsor **Class:** OTHER **Name:** National Polytechnic Institute, Mexico #### Responsible Party **Investigator Affiliation:** National Polytechnic Institute, Mexico **Investigator Full Name:** Cindy Rodríguez Bandala **Investigator Title:** PhD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Obesity is a disease that affects a large part of the world's population and is a risk factor for the development of metabolic, cardiovascular, oncological, and neurodegenerative diseases. Treatments with Gymnema Sylvestre (GS) and Berberine (BBR) have been studied in metabolic diseases such as obesity and type 2 diabetes mellitus (DM2), and have gained importance in recent years, however, questions remain regarding their comparative effect on biochemical parameters, body composition and gene expression of adipokines. Methodology. We carried out a comparative study in 50 adult Mexican patients with a diagnosis of Obesity. Two groups of patients were formed: A. Treated with GS and B. Treated with BBR. Baseline and final measurements were determined 3 months after treatment. Biochemical and body composition parameters were evaluated and the gene expression of Resistin (Res), Omentin (Om), Visfatin (Vis) and Apelin (Ap) was determined, as well as safety parameters. **Detailed Description:** Trial oversight A comparative, descriptive, observational, longitudinal, and prospective analysis study was carried out in the Comprehensive Obesity and Overweight Care Program at the Higher School of Medicine. This study was carried out in full accordance with good clinical practice guidelines and the Declaration of Helsinki. The study was registered with the Research and Ethics Committee of the Higher School of Medicine (ESM.CE-01/7-12-2015). All patients signed the informed consent, and the information was protected through a confidentiality letter. Patients We included 50 Mexican patients of both sexes, of the over 18 years of age, with a body mass index (BMI) greater than 30 KG(kilogram)/M2 (obesity grade I, II and III), without a previous diagnosis of diabetes mellitus, but with at least two risk factors for the disease (history of parents or siblings, over 40 years of age, sedentary lifestyle habits, controlled arterial hypertension, fasting blood glucose \< 126 mg/dL or glycated hemoglobin \< 6.5%). Key exclusion criteria included (i) pregnant patients, (ii) diabetics, and (iii) patients with allergic reaction to any components of the supplements. The first study group, group A (25 patients) was treated with GS at a dose of two 200 mg capsules before breakfast, while in the second group, group B (25 patients) were treated with BBR at dose of one 500 mg tablet three times a day before each meal. In both groups, the treatment lasted 3 months. Trial procedures and outcomes Anthropometric, physiological, and biochemical parameters were measured in two sessions, before and after treatment. The anthropometric measurements were body weight, height, waist, and hip circumference, in addition to body analysis using the Inbody 770. As a physiological measure, only blood pressure was considered using WelchAllyn brand anomanometers with cuff for obese patients. Regarding biochemical parameters, fasting glucose, lipid profile (total cholesterol, triglycerides, HDL, LDL), basal insulin and HbA1c were measured. Adherence to treatment and the presence of adverse effects was recorded using a log that indicated the time at which the tablets were ingested and whether they had any adverse effects that day. Additionally, whole blood samples were taken from 50 patients, 25 had received treatment with GS (group A) and 25 received treatment with BBR (group B). The extraction of tRNA(transfer ribonucleic acid) was carried out using the TRIzol®Reagent technique, which consists of a mixture of guanidine isocyanate and phenol-chloroform. Once the total RNA was isolated, it was suspended in RNase-free water to avoid possible degradation of the sample before proceeding with reverse transcription. The extraction and integrity of the tRNA was verified by means of agarose gel electrophoresis. The final purity of the samples was calculated based on the absorbance obtained with a measurement at 260-280. cDNA(complementary DNA) amplification was performed using the "First Strand cDNA transcription" synthesis kit for rtPCR from Roche. A real-time polymerase chain reaction (RT-PCR) procedure was performed to determine the relative expression of the mRNA(messenger ribonucleic acid) of the genes studied, using probes from the human transcriptome library (Human Universal Probe Library), a LightCycler nano thermocycler and a TaqMan type reaction mixture, all from the Roche Diagnostics brand (Roche Diagnostics GmbH(Gesellschaft mit beschränkter Haftung), Mannheim, Germany). The oligo sequences of the primers (sense and antisense) were designed with ProbeFinder software (Apelin, NM_017413.4, F, 5´ gaa agt ggg gga tgg cta ag 3´, R, 5´ ccc acc cac tac cct ctt ct 3´, Omentin, NM_017625.2, F, 5´ tga ggg tca ccg gat gta ac 3´, R, 5´ gga ctg gcc tct gga aag ta 3´, Resistin, NM_001193374.1, F, 5´ cca ccg aga ggg atg aaa g 3´, R, 5´ ttc ttc cat gga gca cag g 3´ and Visfatin, NM_005746.2, F, 5´ aag gga tgg aac tac att ctt gag 3´, R, 5´ ctg tgt ttt cca ccg tga ag 3'. The reaction mix was prepared according to the manufacturer's protocol. Each sample was analyzed in duplicate, and the data obtained were analyzed with the LightCycler nano software. Statistical analysis The distribution of the quantitative data was performed by Shapiro Wilk. The comparison of frequencies was carried out with X2, while the comparison of basal means between groups was performed with Student's t-test. Final means were compared with Student's t-test when no statistical differences were found in basal comparison, while in the parameters with significant differences in the basal measurement, a covariate adjustment (repeated measures ANOVA) and the Bonferroni test were applied to compare the final means between groups. Self-controlled analysis was performed with paired t test. Analyses were performed with GraphPad Prism software, version 8.0.0 for Windows (GraphPad Software, San Diego, CA, USA), and SPSS software, version 19 (IBM Corp. Released 2015. IBM SPSS Statistics for Windows, Version 19.0. Armonk, NY(New York), USA: IBM Corp). A value of p\<0.05 was considered as statistical significance. ### Conditions Module **Conditions:** - Diabetes Mellitus - Obesity **Keywords:** - Diabetes - Gymnema sylvestre - Berberine - adipokines - obesity ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Comparative, quasi-experimental ##### 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:** Patients who present Obesity administrated with Gymnema sylvestre. At a dose of two 200 mg capsules before breakfast **Intervention Names:** - Dietary Supplement: Gymnema sylvestre **Label:** Gymnema sylvestre **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients who present Obesity administrated with Berberine 500 mg tablet three times a day before each meal **Intervention Names:** - Dietary Supplement: Berberine **Label:** Berberine **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Berberine **Description:** Berberine is an alkaloid derived from plants native to China called Rhizoma coptidis, Cortex phellodendrine and Hydrastis canadensis. These plants are used in the treatment of infectious diarrhea, inflammation, DM2, non-alcoholic fatty liver disease, dyslipidemias, cardiovascular diseases, and obesity. They have been shown to improve insulin sensitivity and stimulate glucose uptake through the activation of AMP-activated protein kinase (AMPK) **Name:** Berberine **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Gymnema sylvestre **Description:** Gymnema sylvestre also known as "meshashringi", is a plant from central and southern India. The leaf extract has been used as a laxative, diuretic, and cough suppressant; Likewise, it has antimicrobial, antihypercholesterolemic, and hepatoprotective activities. It is associated with antioxidant properties . Its adjuvant effect has been reported in the therapy of type 2 diabetes, revealing how its active compounds can influence glucose regulation and improve insulin sensitivity. **Name:** Gymnema sylvestre **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Body weight **Measure:** Body weight **Time Frame:** 3 months **Description:** height **Measure:** height **Time Frame:** 3 months **Description:** waist long **Measure:** waist **Time Frame:** 3 months **Description:** hip circumference **Measure:** hip circumference **Time Frame:** 3 months #### Secondary Outcomes **Description:** blood pressure **Measure:** blood pressure **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Mexican patients of both sexes, of the over 18 years of age, with a body mass index (BMI) greater than 30 KG/M2 (obesity grade I, II and III), without a previous diagnosis of diabetes mellitus, but with at least two risk factors for the disease (history of parents or siblings, over 40 years of age, sedentary lifestyle habits, controlled arterial hypertension, fasting blood glucose \< 126 mg/dL or glycated hemoglobin \< 6.5%) Exclusion Criteria: * pregnant patients, * diabetics, * patients with allergic reaction to any components of the supplements **Healthy Volunteers:** True **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### IPD Sharing Statement Module **Description:** Publication of the article in a JCR journal **IPD Sharing:** NO ### References Module #### References **Citation:** Zhang X, Ha S, Lau HC, Yu J. Excess body weight: Novel insights into its roles in obesity comorbidities. Semin Cancer Biol. 2023 Jul;92:16-27. doi: 10.1016/j.semcancer.2023.03.008. Epub 2023 Mar 24. **PMID:** 36965839 **Citation:** Zwick RK, Guerrero-Juarez CF, Horsley V, Plikus MV. Anatomical, Physiological, and Functional Diversity of Adipose Tissue. Cell Metab. 2018 Jan 9;27(1):68-83. doi: 10.1016/j.cmet.2017.12.002. **PMID:** 29320711 **Citation:** Recinella L, Orlando G, Ferrante C, Chiavaroli A, Brunetti L, Leone S. Adipokines: New Potential Therapeutic Target for Obesity and Metabolic, Rheumatic, and Cardiovascular Diseases. Front Physiol. 2020 Oct 30;11:578966. doi: 10.3389/fphys.2020.578966. eCollection 2020. **PMID:** 33192583 **Citation:** Steppan CM, Bailey ST, Bhat S, Brown EJ, Banerjee RR, Wright CM, Patel HR, Ahima RS, Lazar MA. The hormone resistin links obesity to diabetes. Nature. 2001 Jan 18;409(6818):307-12. doi: 10.1038/35053000. **PMID:** 11201732 **Citation:** Revollo JR, Korner A, Mills KF, Satoh A, Wang T, Garten A, Dasgupta B, Sasaki Y, Wolberger C, Townsend RR, Milbrandt J, Kiess W, Imai S. Nampt/PBEF/Visfatin regulates insulin secretion in beta cells as a systemic NAD biosynthetic enzyme. Cell Metab. 2007 Nov;6(5):363-75. doi: 10.1016/j.cmet.2007.09.003. **PMID:** 17983582 **Citation:** Dakroub A, A Nasser S, Younis N, Bhagani H, Al-Dhaheri Y, Pintus G, Eid AA, El-Yazbi AF, Eid AH. Visfatin: A Possible Role in Cardiovasculo-Metabolic Disorders. Cells. 2020 Nov 9;9(11):2444. doi: 10.3390/cells9112444. **PMID:** 33182523 **Citation:** Ugur K, Erman F, Turkoglu S, Aydin Y, Aksoy A, Lale A, Karagoz ZK, Ugur I, Akkoc RF, Yalniz M. Asprosin, visfatin and subfatin as new biomarkers of obesity and metabolic syndrome. Eur Rev Med Pharmacol Sci. 2022 Mar;26(6):2124-2133. doi: 10.26355/eurrev_202203_28360. **PMID:** 35363362 **Citation:** Huang J, Kang S, Park SJ, Im DS. Apelin protects against liver X receptor-mediated steatosis through AMPK and PPARalpha in human and mouse hepatocytes. Cell Signal. 2017 Nov;39:84-94. doi: 10.1016/j.cellsig.2017.08.003. Epub 2017 Aug 15. **PMID:** 28821440 **Citation:** Li C, Cheng H, Adhikari BK, Wang S, Yang N, Liu W, Sun J, Wang Y. The Role of Apelin-APJ System in Diabetes and Obesity. Front Endocrinol (Lausanne). 2022 Mar 9;13:820002. doi: 10.3389/fendo.2022.820002. eCollection 2022. **PMID:** 35355561 **Citation:** Sperling M, Grzelak T, Pelczynska M, Bogdanski P, Formanowicz D, Czyzewska K. Association of Serum Omentin-1 Concentration with the Content of Adipose Tissue and Glucose Tolerance in Subjects with Central Obesity. Biomedicines. 2023 Jan 24;11(2):331. doi: 10.3390/biomedicines11020331. **PMID:** 36830868 #### See Also Links **Label:** World Health Organization: WHO. **URL:** https://www.who.int/es/news-room/fact-sheets/detail/obesity-and-overweight ## Derived Section ### Condition Browse Module - Ancestors - ID: D000050177 - Term: Overweight - 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: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M12701 - Name: Obesity - Relevance: HIGH - As Found: 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: D000009765 - Term: Obesity ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: Hemat - Name: Hematinics - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: AnTuAg - Name: Antitussive Agents - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: M10365 - Name: Insulin - Relevance: LOW - As Found: Unknown - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: LOW - As Found: Unknown - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4292 - Name: Antioxidants - Relevance: LOW - As Found: Unknown - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M7411 - Name: Diuretics - Relevance: LOW - As Found: Unknown - ID: M27664 - Name: Laxatives - Relevance: LOW - As Found: Unknown - ID: M5651 - Name: Cathartics - Relevance: LOW - As Found: Unknown - ID: M4312 - Name: Antitussive Agents - Relevance: LOW - As Found: Unknown - ID: T180 - Name: Gymnema Sylvestre - Relevance: HIGH - As Found: Acoustic Wave - ID: T171 - Name: Goldenseal - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426953 **Brief Title:** Predictive Effect of TGF-β Combined With INS-PI3K-AKT Signaling Pathway Related Proteins (ADNP, MAP6, Pgc-1α) for POD on Diabetes Patients **Official Title:** Predictive Effect of TGF-β Combined With INS-PI3K-AKT Signaling Pathway Related Proteins (ADNP, MAP6, Pgc-1α) for POD on Diabetes Patients #### Organization Study ID Info **ID:** IRB-2024-467（IIT） #### Organization **Class:** OTHER **Full Name:** Zhejiang Cancer Hospital ### Status Module #### Completion Date **Date:** 2026-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Xie Kangjie #### Responsible Party **Investigator Affiliation:** Zhejiang Cancer Hospital **Investigator Full Name:** Xie Kangjie **Investigator Title:** MD **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** To investigate the relationship between POD, TGF-β and INS-PI3K-AKT signaling pathway related proteins (ADNP, MAP6, PGC-1α) in diabetic patients **Detailed Description:** The study was a single-center, prospective，single blind (blinded to subjects and evaluators)，control, observational clinical study. We will collect 3 milliliters of blood from enrolled patients before surgery begins. The collected blood samples were processed and stored in -80℃ refrigerator. All samples were tested TGF-β and INS-PI3K-AKT signaling pathway related proteins (ADNP, MAP6, PGC-1α) by ELISA. ### Conditions Module **Conditions:** - Diabetes - Postoperative Delirium ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 180 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: No intervention **Label:** History of diabetes ≥2 years and Glycated hemoglobin ≥6.5% #### Arm Group 2 **Intervention Names:** - Other: No intervention **Label:** No history of diabetes and normal blood glucose ### Interventions #### Intervention 1 **Arm Group Labels:** - History of diabetes ≥2 years and Glycated hemoglobin ≥6.5% - No history of diabetes and normal blood glucose **Description:** No intervention **Name:** No intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The related proteins were detected by ELISA **Measure:** To investigate the relationship between POD and TGF-β, INS-PI3K-AKT signaling pathway related proteins (ADNP, MAP6, pgc-1α) in diabetic patients. **Time Frame:** 2024-05 to 2026-06 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age ≥65 years 2. History of diabetes ≥2 years and Glycated hemoglobin ≥6.5% or no history of diabetes and normal blood glucose 3. The ASA rating is Class I to III 4. The elderly patients of limited thoracic and abdominal tumor surgery Exclusion Criteria: 1. Refused to participate 2. Previous history of schizophrenia, epilepsy, Parkinson's disease 3. History of alcohol abuse or drug dependence 4. Patients with ASA grade IV and above 5. Severe visual or hearing impairment, can not cooperate with the completion of cognitive function tests 6. Participants in other clinical trials within the last two months 7. Patients with severe arrhythmia or cardiac dysfunction(EF\<40%) 8. There was a clear history of neurological and psychiatric problems or long-term use of sedatives or antidepressants 9. History of cerebrovascular disease or brain surgery or trauma 10. Severe liver dysfunction (Child-Pugh class C) or severe renal dysfunction (requiring dialysis) **Minimum Age:** 65 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - OLDER_ADULT **Study Population:** Elderly patients with a history of diabetes ≥2 years and a glycated hemoglobin of ≥6.5% or without a history of diabetes and a normal blood glucose level ### Contacts Locations Module #### Locations **Location 1:** **City:** Hangzhou **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** XIE Kangjie, MD - **Phone:** 13516721870 - **Role:** CONTACT **Country:** China **Facility:** Zhejiang Cancer Hospital **State:** Zhejang **Status:** RECRUITING **Zip:** 310000 **Location 2:** **City:** Hangzhou **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Kangjie Xie, MD - **Phone:** 008613516721870 - **Role:** CONTACT **Country:** China **Facility:** Zhejiang Cancer Hospital **State:** Zhejiang **Status:** RECRUITING **Zip:** 310022 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000003693 - Term: Delirium - ID: D000003221 - Term: Confusion - ID: D000019954 - Term: Neurobehavioral Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes ### 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 - Abbrev: BC10 - Name: Nervous 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: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes - ID: M6894 - Name: Delirium - Relevance: LOW - As Found: Unknown - ID: M772 - Name: Emergence Delirium - Relevance: HIGH - As Found: Postoperative Delirium - 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 - ID: M6446 - Name: Confusion - 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: 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: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: T929 - Name: Camurati-Engelmann Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000071257 - Term: Emergence Delirium - ID: D000003920 - Term: Diabetes Mellitus ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Analg - Name: Analgesics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M207501 - Name: Chrysarobin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426940 **Brief Title:** Anesthesia-Related Peroperative Critical Events **Official Title:** Prospective Analysis of Anesthesia-Related Peroperative Critical Events in a Tertiary Care Hospital #### Organization Study ID Info **ID:** SBÜTrabzon #### Organization **Class:** OTHER **Full Name:** Zonguldak Bulent Ecevit University ### Status Module #### Completion Date **Date:** 2020-09-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-09-01 **Type:** ACTUAL #### Start Date **Date:** 2020-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Gamze Küçükosman #### Responsible Party **Investigator Affiliation:** Zonguldak Bulent Ecevit University **Investigator Full Name:** Gamze Küçükosman **Investigator Title:** associate professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Peroperative anesthesia-related critical events (CE) lead to adverse health outcomes in patients. To minimize recurrence of these outcomes, identifying problems causing CEs and obtaining information about their frequency and severity are important. This study aims to determine the frequency of anesthesia-related CEs occurring within intraoperative and postoperative 1 hour (h) in surgical patients at our tertiary care hospital, by system. ### Conditions Module **Conditions:** - the Frequency of Anesthesia-related Critical Events ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 1904 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: anesthesia-related critical events **Label:** intraoperative anesthesia-related critical events #### Arm Group 2 **Intervention Names:** - Other: anesthesia-related critical events **Label:** postoperative 1 hour (h)anesthesia-related critical events ### Interventions #### Intervention 1 **Arm Group Labels:** - intraoperative anesthesia-related critical events - postoperative 1 hour (h)anesthesia-related critical events **Description:** anesthesia-related critical events **Name:** anesthesia-related critical events **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** This study aims to determine the frequency of anesthesia-related CEs occurring within intraoperative and postoperative 1 hour (h) in surgical patients at our tertiary care hospital, by system. **Measure:** Prospective Analysis of Anesthesia-Related Peroperative Critical Events in a Tertiary Care Hospital **Time Frame:** within intraoperative and postoperative 1 hour ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All patients Exclusion Criteria: * intubated outside the operating room * taken into operation from the intensive care unit (ICU). **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Age, gender, ASA (the American Society of Anesthesiologists) risk, surgical clinic, anesthesia method (general/regional/local/sedation/local+sedation), anesthesia and surgery duration of the patients, and anesthesia-related CEs occurring within intraoperative and postoperative 1 h were recorded. ### Contacts Locations Module #### Locations **Location 1:** **City:** Zonguldak **Country:** Turkey **Facility:** Gamze Küçükosman #### Overall Officials **Official 1:** **Affiliation:** Zonguldak Bulent Ecevit University **Name:** gamze küçükosman **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs ### 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: M4107 - Name: Anesthetics - Relevance: HIGH - As Found: Function ### Intervention Browse Module - Meshes - ID: D000000777 - Term: Anesthetics ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426927 **Acronym:** PeLear CCC **Brief Title:** PeLear CCC: Proyecto Latino Contra Cancer Colorectal **Official Title:** A Colorectal Cancer Educational Intervention in the Latino Community Assessing the Feasibility of Recruitment & Retention Via a Church-Based Approach: Identification of Novel Barriers to Cancer Clinical Trial Enrollment #### Organization Study ID Info **ID:** 22-2980 #### Organization **Class:** OTHER **Full Name:** University of North Carolina, Chapel Hill #### Secondary ID Infos **Domain:** NCTraCS Institute **ID:** CTSC0205 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** North Carolina Translational and Clinical Sciences Institute #### Lead Sponsor **Class:** OTHER **Name:** University of North Carolina, Chapel Hill #### 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 recruit 60 Spanish speaking individuals who identify as Latinos, are older than 18 years old and attend the Saint Thomas More (STM) Church in Chapel Hill. Study participants will be asked to attend an educational session at STM Church during which their baseline knowledge on colorectal cancer (CRC) and willingness to participate in cancer clinical trials (CCT) will be assessed through a questionnaire in Spanish. Following this, participants will watch three educational videos on CRC in Spanish. After watching the videos, CRC knowledge and willingness to participate in CCTs will be reassessed. Thirty +/- 7 days after participation in the educational session, participants will be invited back at STM Church in order to complete a follow-up questionnaire assessing CRC knowledge, willingness to participate in CCTs and perceived barriers preventing Latinos from participating in CCTs. Twenty of the 60 recruited participants will be asked to participate in a qualitative one-on-one interview aimed at identifying barriers preventing Latinos from participating in CCTs. It should be noted that cancer is the leading cause of death in the United States (US) Latino community, with CRC accounting for 10% of this overall mortality. Despite this, Latinos suffer from disparities in access to care, cancer screening, treatment, and representation in CCTs. In fact, although Latino individuals are among the largest and fastest growing communities of color in the US, currently comprising 18.7%, their representation in CCTs remains low. This is of concern because: 1) advances arising from trials with limited Latino representation may not be applicable to the Latino population, and 2) decreased Latino participation in CCTs may delay Latino access to novel therapies in a timely fashion. The investigators conducting this study believe that low cancer-specific health knowledge may be impacting Latino representation and willingness to participate in CCTs and can be addressed through culturally and linguistically appropriate community-based educational interventions. Latino CCT underrepresentation is a multifaceted phenomenon and bidirectional barriers at the physician-, healthcare system-, and patient-level are significant contributors. Therefore, understanding the multiple driving forces and barriers is essential to identifying potential targets for improvement. **Detailed Description:** This pilot project aims to address the Clinical and Translational Science (CTS) roadblock of underrepresentation of Latinos in cancer clinical trials (CCTs) through a community-based, culturally, and linguistically appropriate educational intervention aimed at increasing health knowledge on a specific cancer. Colorectal cancer (CRC) will be the "use case" and the church will be the venue for Latino recruitment. This project will lead to the identification of novel Latino-perceived barriers to CCT enrollment, which will be applicable in other fields of medicine aiming to increase Latino CCT enrollment. The investigators believe that one barrier to recruitment for CCTs is low health education, specifically regarding cancers affecting the community, such as CRC, a commonly diagnosed cancer in the US Latino population. Therefore, the hypothesis that an increase in health knowledge in Latinos on a specific cancer mediates a change in their willingness to participate in CCTs will be tested. To do this, three educational CRC videos in Spanish will be created. The first video will review CRC symptoms, the second video will review CRC risk factors while the third video will provide information on CRC screening, treatment and CCTs. In addition, a translated, non-validated questionnaire based on 3 sub-scales from 2 CRC knowledge questionnaires previously validated in English will be developed and pilot tested. Therefore, the Specific Aims of this Pilot Project are to: 1. Identify novel Latino-perceived barriers to participation in CCTs. 2. Assess the association between an educational video and CRC knowledge. 3. Explore the potential relationship between an increase in health knowledge of a specific cancer via an educational video in Spanish and willingness to participate in CCTs. 4. Demonstrate that engagement with Latino communities via the church setting is a viable option for the recruitment and retention of Latinos. 5. Translate into Spanish and pilot test 3 health knowledge sub-scales as a preliminary step in the creation and validation of a novel Spanish CRC knowledge questionnaire. To achieve these aims, recruit 60 Latino, Spanish speaking attendees of the Saint Thomas More (STM) Church in Chapel Hill will be recruited. The study will consist of three Study Days: 1. Study Day 1: Enrolled participants will be asked to attend an educational session at STM Church. During the educational session their baseline knowledge on CRC and their baseline willingness to participate in CCTs will be assessed through a questionnaire in Spanish. Following this, participants will watch three educational CRC videos in Spanish and then their CRC knowledge as well as their willingness to participate in CCTs will be reassessed. 2. Study Day 2: Thirty +/- 7 days after the educational session, participants will be asked to return to STM Church in order to complete a follow-up questionnaire in Spanish. The questionnaire will assess their level of retainment of CRC knowledge, their willingness to participate in CCTs as well as assess in an open-ended fashion their perceived barriers to CCT participation. 3. Study Day 3: Twenty of the 60 enrolled participants will be asked to participate in a qualitative one-on-one interview aimed at identifying Latino perceived barriers to CCT participation. ### Conditions Module **Conditions:** - Colorectal Cancer - Rectal Cancer - Colon Cancer - Colon Rectal Cancer - Rectal Neoplasms - Colon Adenocarcinoma - Hereditary Nonpolyposis Colon Cancer **Keywords:** - Colorectal Cancer - Latinx - Barriers - Cancer Clinical Trials - Latino - Spanish - Familial Colorectal Cancer - Lynch Syndrome - Hispanic ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Enrolled participants will watch three educational videos in Spanish pertaining to: (1) Colorectal Cancer (CRC) symptoms; (2) CRC risk factors and (3) CRC screening, treatment, and Cancer Clinical Trials (CCT). **Intervention Names:** - Other: Colorectal Cancer Educational Videos in Spanish **Label:** Educational Videos **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Educational Videos **Description:** Enrolled participants will watch three educational videos on Colorectal Cancer (CRC) in Spanish. Knowledge on CRC symptoms, risk factors, screening and treatment will be assessed before and immediately after the educational video and at 30 +/- 7 days. In addition, the association between increase in CRC knowledge and willingness to participate in Cancer Clinical Trials (CCT) will be explored. **Name:** Colorectal Cancer Educational Videos in Spanish **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Qualitative, semi-structured, one-on-one interviews will be performed in Spanish. The interviews will be recorded and transcribed. The ATLAS.ti software will be used for the transcript analysis. The top 2 conceptual themes within each section of the interview-attitudes regarding general clinical trials, attitudes regarding cancer clinical trials, and perceptions of the Hispanic/Latino community-and the top 3 higher-level, holistic themes across the sections will be reported in terms of percentage of participants. **Measure:** Barriers Preventing Latinos from Participating in Cancer Clinical Trials **Time Frame:** 30 days after participation in Study Day 2 #### Secondary Outcomes **Description:** Use of appropriate statistical measures to compare total number of correct responses across three time points (at baseline, post-video and 30+/- 7 days follow-up) accounting for multiple observations within subjects. Knowledge pertaining to Colorectal Cancer (CRC) symptoms will be assessed using the "Knowledge of Warning Signs" questions from the "Bowel Cancer Awareness Measure". Potential answers include "Yes", "No" and "Don't Know". The overall score will range from 0 to 9 and it is anticipated that average scores will increase after the intervention. Higher scores imply greater knowledge of symptoms. **Measure:** Association of Educational Videos on Knowledge of Colorectal Cancer Symptoms **Time Frame:** On Study Day 1: Immediately before and 30 minutes after the video projection and on Study Day 2 **Description:** Use of appropriate statistical measures to compare mean proportion of correct responses across three time points (at baseline, post-video and 30+/- 7 days follow-up) accounting for multiple observations within subjects. Knowledge pertaining to Colorectal Cancer (CRC) risk factors will be assessed using the "Knowledge of Risk Factors" questions from the "Bowel Cancer Awareness Measure". This scale is measured using a Likert 1-5 scale with "1" corresponding to "Strongly Disagree" and "5" corresponding to "Strongly Agree". The overall score will range from 11 to 55 and it is anticipated that the average scores will increase after the intervention. Higher scores imply greater knowledge of risk factors. **Measure:** Association of Educational Videos on Knowledge of Colorectal Cancer Risk Factors **Time Frame:** On Study Day 1: Immediately before and 30 minutes after the video projection and on Study Day 2 **Description:** Use of appropriate statistical measures to compare mean proportion of correct responses across three time points (at baseline, post-video and 30+/- 7 days follow-up) accounting for multiple observations within subjects. Knowledge of Colorectal Cancer (CRC) screening and general facts will be assessed using nine questions from the "Colorectal Cancer Screening Decision Quality Instrument (CRC-DQI)". The overall score will range from 0 to 9 and it is anticipated that average scores will increase after the intervention. Higher scores imply greater knowledge of symptoms. **Measure:** Association of Educational Videos on Knowledge of Colorectal Cancer Screening and Facts **Time Frame:** On Study Day 1: Immediately before and 30 minutes after the video projection and on Study Day 2 **Description:** Appropriate statistical measures on the paired responses of participants will be used to test the association between watching the video and willingness to participate in CCTs. The mediating effect of health knowledge levels (M) on the relationship between educational video (X) and willingness to participate in CCTs (Y) will be explored. In a structural equation model with a series of mixed-effects generalized linear models, Y will be predicted by both X and M, combining the estimated relationship of M and Y. The mediated indirect effect (from X to Y, through M) will then be estimated and tested using the bootstrapping method with 1,000 replications, and the proportion of the effect being mediated will be reported as the effect size. **Measure:** Association of Watching the Video and Willingness to Participate in Cancer Clinical Trials **Time Frame:** On Study Day 1: Immediately before and 30 minutes after the video projection and on Study Day 2 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Spanish speaking * Identifying as Latino * Older than 18 years old Exclusion Criteria: * Non-Spanish speakers * Not identifying as Latino * Younger than 18 years old **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:** José G. Guillem, MD, MPH, MBA **Phone:** 919-966-8436 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Dimitrios Varvoglis, MD **Phone:** 919-966-8436 **Role:** CONTACT #### Locations **Location 1:** **City:** Chapel Hill **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jose G Guillem, MD, MPH, MBA - **Phone:** 919-966-8436 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Dimitrios Varvoglis, MD - **Phone:** 919-966-8436 - **Role:** CONTACT **Country:** United States **Facility:** Saint Thomas More Church **State:** North Carolina **Zip:** 27514 #### Overall Officials **Official 1:** **Affiliation:** University of North Carolina, Chapel Hill **Name:** José G. Guillem, MD, MPH, MBA **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Sepucha KR, Feibelmann S, Cosenza C, Levin CA, Pignone M. Development and evaluation of a new survey instrument to measure the quality of colorectal cancer screening decisions. BMC Med Inform Decis Mak. 2014 Aug 20;14:72. doi: 10.1186/1472-6947-14-72. **PMID:** 25138444 **Citation:** American Cancer Society. Cancer Facts & Figures for Hispanic/Latino People 2021-2023. Atlanta: American Cancer Society, Inc. 2021. **Citation:** Power E, Simon A, Juszczyk D, Hiom S, Wardle J. Assessing awareness of colorectal cancer symptoms: measure development and results from a population survey in the UK. BMC Cancer. 2011 Aug 23;11:366. doi: 10.1186/1471-2407-11-366. **PMID:** 21859500 #### See Also Links **Label:** Bowel Cancer Awareness Measure **URL:** https://www.cancerresearchuk.org/sites/default/files/health_professional_bowel_cam_toolkit_version_2.1_09.02.11.pdf **Label:** Racial and Ethnic Composition of the United States **URL:** https://www.census.gov/library/stories/2021/08/improved-race-ethnicity-measures-reveal-united-states-population-much-more-multiracial.html **Label:** National Cancer Institute Triennial Inclusion of Women and Minorities in Clinical Research Report **URL:** https://report.nih.gov/sites/report/files/docs/NCITriennialInclusionReportFY2019_FY2021Final.pdf ## 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 - ID: D000009386 - Term: Neoplastic Syndromes, Hereditary - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000049914 - Term: DNA Repair-Deficiency Disorders - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M14846 - Name: Rectal Neoplasms - Relevance: HIGH - As Found: Rectal Cancer - ID: M17890 - Name: Colorectal Neoplasms - Relevance: HIGH - As Found: Colorectal Cancer - ID: M6338 - Name: Colonic Neoplasms - Relevance: HIGH - As Found: Colon Cancer - ID: M6351 - Name: Colorectal Neoplasms, Hereditary Nonpolyposis - Relevance: HIGH - As Found: Hereditary Nonpolyposis Colon 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: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System 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: M12331 - Name: Neoplastic Syndromes, Hereditary - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M26131 - Name: DNA Repair-Deficiency Disorders - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: T2203 - Name: Familial Colorectal Cancer - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015179 - Term: Colorectal Neoplasms - ID: D000012004 - Term: Rectal Neoplasms - ID: D000003110 - Term: Colonic Neoplasms - ID: D000003123 - Term: Colorectal Neoplasms, Hereditary Nonpolyposis ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426914 **Brief Title:** Clinical Pilates (CP) Exercises and Kinesiophobia in CABG **Official Title:** Effect of Clinical Pilates (CP) Exercises on Kinesiophobia and Post-operative Cardiopulmonary Parameters in CABG Patients. #### Organization Study ID Info **ID:** Sarosh Gohar #### Organization **Class:** OTHER **Full Name:** Riphah International University ### Status Module #### Completion Date **Date:** 2024-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### 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:** True ### Description Module **Brief Summary:** To determine Effect of Clinical Pilates (CP) exercises on kinesiophobia and post-operative cardiopulmonary parameters in CABG patients. Kinesiophobia may lead to patients\&#39; psychological fear of rehabilitation exercise, thereby refusing rehabilitation exercise, affecting the rehabilitation process of patients, resulting in disuse syndrome, depression, disability and other adverse consequences. Thus, this study is to be conducted to find out the effects Pilates exercises with cardiac rehabilitation for management of Kinesiophobia in post CABG patients. **Detailed Description:** Clinical Pilates are also evident to be safe and effective in post-surgical patients with different surgical interventions. A study was conducted in 2021 to evaluate the effects of the Pilates method on pulmonary function and range of motion after coronary artery bypass grafting and concluded that the Pilates method is a safe, viable, and playful option for the patient profile after CABG but they did not evaluate kinesiophobia of patients ### Conditions Module **Conditions:** - Post-cardiac Surgery **Keywords:** - CABG - Clinical Pilates - Kinesiophobia - Post-operative cardiopulmonary parameters ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Pilates Clinical (Introductory program) **Intervention Names:** - Other: Clinical Pilates **Label:** Interventional **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Cardiac Rehabilitation **Intervention Names:** - Other: Cardiac Rehabilitation **Label:** Control **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Interventional **Description:** Warmup: 5-10 minutes Pilates Clinical (Introductory program) The Hundred modified The Roll-up modified The roll-over modified Spine twist modified Single-leg circle modified Rolling like a ball Shoulder Bridge modified For every Step emphasizing: FOCUS: On muscle involved REPETITIONS: 3-5 VISUALIZATION: Imagination process (Different for each step) Cool down: 5 minutes Total Time: 30 minutes **Name:** Clinical Pilates **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Control **Description:** Chest Physical therapy (Chest percussions and active huffs as per need) Breathing strategies (Diaphragmatic and purse lip 1-3 sets \* 5 Reps/Day) Functional mobility (walk /cycling as per patient tolerance) Patient education and Wound care Sternal Precaution guidance **Name:** Cardiac Rehabilitation **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Changes from baseline to 2 weeks and 4 weeks after intervention, measured through the TSK-SV Heart specifically focuses on assessing Kinesiophobia in the context of cardiac conditions or symptoms. It include questions related to fear of engaging in physical activity due to concerns about cardiac events (such as heart palpitations, chest pain, or shortness of breath) during exercise or daily activities. The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible Kinesiophobia, and the higher scores indicate an increasing degree of Kinesiophobia. **Measure:** Kinesiophobia **Time Frame:** 2 weeks, 4 weeks **Description:** Post-operative period and discharge day observed through Electrocardiography (ECG) on cardiac monitor. **Measure:** Abnormal heart rhythms **Time Frame:** 2 Weeks, 6 Weeks #### Secondary Outcomes **Description:** Changes from baseline to 2 weeks and 4 weeks after intervention, measured through the 10 meter walk test. It is a performance measure test used to assess walking speed in meters per second over a short distance . It can be employed to determine functional mobility. **Measure:** Functional mobility **Time Frame:** 2 weeks, 4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Hemodynamically stable patient Who underwent elective CABG. Patients diagnosed with Kinesiophobia via Tampa scale for Kinesiophobia Heart (TSK-SV Heart) Exclusion Criteria: Neuromuscular conditions which lead to kinesiophobia Diseases that seriously affected the functional capacity or mobility such as liver cirrhosis, chronic renal failure and disabled patients. Prolong intubation Vital instability Patients needing maximum assistance Decline consent **Maximum Age:** 60 Years **Minimum Age:** 30 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Mehwish Waseem, MSPT-CPPT **Phone:** 0331-5309015 **Role:** CONTACT #### Locations **Location 1:** **City:** Peshawar **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Mehwish Waseem, MSPT-CPPT - **Phone:** 0331-5309015 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Sarosh Gohar, MSPT-CPPT* - **Phone:** 0303-5887220 - **Role:** CONTACT **Country:** Pakistan **Facility:** Lady Reading Hospital **State:** KPK **Status:** RECRUITING **Zip:** 25000 #### Overall Officials **Official 1:** **Affiliation:** Riphah International University **Name:** Mehwish Waseem, MSPT-CPPT **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010698 - Term: Phobic Disorders - ID: D000001008 - Term: Anxiety 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: M2922 - Name: Kinesiophobia - Relevance: HIGH - As Found: Kinesiophobia - ID: M13603 - Name: Phobic Disorders - Relevance: LOW - As Found: Unknown - ID: M4324 - Name: Anxiety 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: D000092442 - Term: Kinesiophobia ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426901 **Brief Title:** Effects of Tan Tui Exercises on Strength and Performance of Football Players. **Official Title:** Effects of Tan Tui Exercises on Strength and Performance of Football Players. #### Organization Study ID Info **ID:** REC/01835 Naveed Ullah #### Organization **Class:** OTHER **Full Name:** Riphah International University ### Status Module #### Completion Date **Date:** 2024-10-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-26 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-10-20 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### 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:** True ### Description Module **Brief Summary:** Randomized controlled trial (RCT) to investigate the effects of Tan Tui exercises on the strength and performance of football players. Tan Tui can provide football players with a well-rounded approach to physical and mental development, which can contribute to enhanced performance, injury prevention, and personal improvement both on and off the field there is limited study available on the effectiveness of Tan Tui exercises. **Detailed Description:** Tan Tui training develops mental fortitude, focus, and discipline. Football players can benefit from better concentration, emotional resilience, and the capacity to remain calm under pressure. While football generally focuses on offensive and defensive strategies, mastering Tan Tui self-defense techniques can teach players with real abilities for personal protection off the field. Tan Tui can help with injury prevention by increasing flexibility and body awareness. Tan Tui practitioners are frequently more equipped to avoid strains and sprains. The meditative aspects of Tan Tui training can help football players manage stress and anxiety, improving their mental well-being and overall quality of life. ### Conditions Module **Conditions:** - Football Players **Keywords:** - Agility - Quickness - Change direction - Skills - Strength ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** group1 ,experimental group group 2 control group ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** OTHER #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Experimental Group A Springing Leg Forms." var-arranged sequences of movements that incorporate kicks, strikes, and blocks. Pattern Drills: Pattern drills involve repeating specific combinations of kicks, strikes, and blocks in a repetitive manner. Basic Kicking Drills: which involve ious types of kicks such as front kicks, sidekicks, roundhouse kicks, and crescent kicks. Stance Work: Practitioners work on a variety of stances, including horse stance (ma bu), bow stance (gong bu), and cat stance (mao bu). Forms (Taolu): These forms consist of predrills enhance muscle memory and the ability to execute techniques quickly and accurately. Conditioning: includes rigorous conditioning exercises to strengthen the legs and develop endurance. Sparring (San Shou): bouncing leg exercise intervention cycle lasted 6 weeks, 3 times a week for 30 minutes each. The intervention was split into two parts: motor learning in the first week and motor improvement in the last five weeks. . **Intervention Names:** - Other: Effects of Tan Tui Exercises on Strength and Performance of Football Players. **Label:** Experimental Group: the group A will be received Tan Tui exercies **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Conventional exercises Squats: Squats are a foundational lower-body exercise that targets the quadriceps, hamstrings, glutes, and lower back. Bench Press: The bench press is a classic upper-body exercise that targets the chest, shoulders, and triceps. Power Cleans: Similar to the clean and jerk, power cleans are used to develop explosive power, especially in the legs and hips. Pull-Ups/Chin-Ups: Pull-ups and chin-ups strengthen the muscles of the upper back, shoulders, and arms. Push-Ups: Push-ups are a versatile exercise that works the chest, shoulders, triceps, and core. Lunges: Lunges are excellent for targeting the quadriceps, hamstrings, and glutes while also improving balance and stability. Core Exercises: Core strength is vital for stability and balance in football. Exercises like planks, Russian twists, and medicine ball throws target the core muscles. **Label:** Controlled **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental Group: the group A will be received Tan Tui exercies **Description:** Tan Tui, Exercises Tan Tui, is a style of traditional Chinese martial art that emphasizes leg techniques, agility, and conditioning. Basic Kicking Drills. Stance Work. Forms (Taolu) Pattern Drills. Conditioning.Sparring (San Shou). This protocol will be implemented by District Physiotherapist who will visit the mentioned Football academies in group session. **Name:** Effects of Tan Tui Exercises on Strength and Performance of Football Players. **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Modified Hand Held Dynamometers (will assess the power of lower limb Muscle) **Measure:** Hand Held Dynamometer **Time Frame:** 6 weeks #### Secondary Outcomes **Description:** The Agility T-Test is a fitness test that is commonly used in sports and physical fitness training to assess an individual's agility, speed, and quickness. It is especially common in sports requiring quick changes of direction, such as basketball, soccer, football, and tennis. The exam is named after the T-shaped running course that participants must complete in the shortest amount of time. **Measure:** Agility T-Test **Time Frame:** 6th week ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria Male Player * Player of academy from last 1 year * Aged 18-35 years. * BMI (19-29) Exclusion Criteria: * • Surgical History * Fracture History * Meniscal pathology * Knee injury due to trauma **Maximum Age:** 35 Years **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Riafat Mehmood, PhD* **Phone:** 03132139115 **Role:** CONTACT #### Locations **Location 1:** **City:** Dīr **Country:** Pakistan **Facility:** Timergara Football club **State:** KPK **Zip:** 18300 #### Overall Officials **Official 1:** **Affiliation:** Riphah International University **Name:** Riafat Mehmood **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426888 **Brief Title:** Comparison of Scapular Stabilization and Mobilizations in Sub Acromial Pain Syndrome **Official Title:** Comparison of Scapular Stabilization Exercises and Scapular Mobilizations in Patients With Sub Acromial Pain Syndrome #### Organization Study ID Info **ID:** Riphah IU Gulban Aslam #### Organization **Class:** OTHER **Full Name:** Riphah International University ### Status Module #### Completion Date **Date:** 2024-07-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### 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:** The aim of this research is to compare the effect Comparison of scapular stabilization exercises and scapular mobilizations on shoulder pain, scapular kinematics, disability and functional limitations in patients with sub acromial pain syndrome Randomized controlled trials done at District Head Quarters Mirpur AJK. The sample size was 36. The subjects were divided in two groups, 18 subjects in scapular mobilization exercise group and 18 in scapular mobilization exercise therapy group. Study duration was of 12 months. Sampling technique applied was non probability convenient sampling technique. Only 25-40 years old patient with unilateral shoulder pain lasting \>6 weeks were included. Tools used in the study are NPRS, SPADI, WORC LSST and SAT. **Detailed Description:** Sub acromial pain syndrome (SAPS), an up to date terminology (shoulder impingement syndrome ) is a common healthcare problem, especially in adult where the space directly below the acromion process and above the shoulder joint, has narrowed and patients describe pain on lateral and anterior aspect of shoulder . The estimated prevalence in the general population is 7 to 26 percent and it accounts for 44 to 65% of all shoulder problems. Incidence of shoulder impingement in the US military population is 7.77 cases/1000 person-years and in UK 3 out of every 4 patient with shoulder pathologies are seeking medical treatment for SAPS. Risk factors include repetitive activity above the shoulder, decubitus sleeping position, a hook-type acromion, smoking, muscle imbalance, bone and joint abnormalities etc. Common symptoms are persistent pain without any history of trauma, difficulty reaching up behind the back, weakness in shoulder muscles, pain when the arm is raised between 70 and 120 degrees and scapular dyskinesia. * Research surrounding sub acromial pain syndrome has experienced significant growth recently especially in the area of its management. Physiotherapy management protocol for SAPS includes, postural correction exercises, neuromuscular control exercises, Stretching's, manual therapy techniques of the shoulder, scapular stabilization and Mobility Exercises and myofacial release therapy. Scapular stabilization exercises based on open and closed kinetic chain exercises to increase muscle strength and joint position awareness. ### Conditions Module **Conditions:** - Subacromial Impingement Syndrome **Keywords:** - Scapular stabilization exercises - Range of motion - scapular mobilization ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 1. Ball stabilization exercise, 2.Wall push up 3. Wall push up Patients will be treated 3 times per week for 4 consecutive weeks **Intervention Names:** - Other: Experimental interventional group 1(scapular stabilization exercise therapy) **Label:** Experimental interventional group 1(scapular stabilization exercise therapy) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** scapular mobilization in elevation, depression, protraction and retraction. Patients will be treated 3 times per week for 4 consecutive weeks **Intervention Names:** - Other: Experimental :interventional group II (scapular mobilizations) **Label:** Experimental :interventional group II (scapular mobilizations) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental interventional group 1(scapular stabilization exercise therapy) **Description:** Ball stabilization exercise: While standing close to the wall, the participant will be asked to position her affected hand on the ball and keep the ball from moving as disturbance will be applied in different directions. Wall push up: While facing wall patient will be asked to place both hands on wall, shoulder width apart. He will be instruct to breath in, bend his elbows, lean into wall and hold this position for one second then breath out slowly push back until arms are straight again Wall slides • Patient will be asked to lean his head, upper thorax and butts against the wall, place his hands and arms against the wall in high five position. **Name:** Experimental interventional group 1(scapular stabilization exercise therapy) **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Experimental :interventional group II (scapular mobilizations) **Description:** Patient lies on unaffected side close to the edge of the treatment bench with hips and knees bent for stability. Therapist will start by supporting the patient arm on his/her forearm so that shoulder is in maximally loose pack position. Then he/she will grab on the scapula with both hands. One hand supports the scapula from cranial around the acromion and scapular spine and other hand from the caudal at the inferior angle of scapula. Then both hands move the scapula cranially over the thorax into elevation and caudally into the depression, upward/downward rotation as well as retraction and protraction. **Name:** Experimental :interventional group II (scapular mobilizations) **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** It has 21 items, exploring 5 different domains: Physical symptoms, Sports and recreation, Work, Social function, Emotions. Each question uses a visual analogue scale (VAS) - which is a straight line, representing a 100-point scale, ranging from 0-100. **Measure:** Western Ontario Rotator Cuff Index (WORC) **Time Frame:** baseline to 4 weeks **Description:** this test measures the distance between inferior angle of scapula and nearest vertebral spinous process using tape or goniometer in neutral, 45 and 90 degrees of shoulder abduction with the arms fully internally rotated **Measure:** Lateral Scapular Slide Test (LSST) **Time Frame:** baseline to 4 weeks #### Secondary Outcomes **Description:** SPADI measures pain and disability related to shoulder pain and It has 13 items with response options ranging from 0(no pain) to 10 (worst pain), the overall score ranges from 0 to 100. **Measure:** Shoulder Pain and Disability Index (SPADI) **Time Frame:** baseline to 4 weeks **Description:** This is an 11 point outcome measure used to measure intensity of pain ranging from 0 (no pain) to 10 (worst imaginable pain) **Measure:** Numeric pain rating scale **Time Frame:** baseline to 4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ● Unilateral shoulder pain lasting \>6 weeks * Patients with 3/5 positive special tests (Hawkins-Kennedy test, painful arc test, Neer test, Job test, resisted external rotation test) * Patients score falling above 3 on NPRS Exclusion Criteria: * • History of surgery, fracture, or dislocation in past 6 months * Traumatic onset of pain. * received steroid injections and physical therapy during the previous 6 months * BMI above 30 **Maximum Age:** 40 Years **Minimum Age:** 25 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Imran Amjad, PHD **Phone:** 03324390125 **Role:** CONTACT #### Locations **Location 1:** **City:** Mirpur **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Aisha Razzaq, PHD* - **Phone:** 03015030784 - **Role:** CONTACT ***Contact 2:*** - **Name:** Gulban Aslam, MSPT-OMPT* - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Pakistan **Facility:** District Head Quarters **State:** Azad Jammu Kashmir **Status:** RECRUITING **Zip:** 10250 #### Overall Officials **Official 1:** **Affiliation:** Riphah International University **Name:** aisha Razzaq, PHD* **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000070599 - Term: Shoulder Injuries - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M21476 - Name: Shoulder Impingement Syndrome - Relevance: HIGH - As Found: Subacromial Impingement Syndrome - ID: M13066 - Name: Pain - 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: M602 - Name: Shoulder Injuries - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000019534 - Term: Shoulder Impingement Syndrome - ID: D000013577 - Term: Syndrome ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426875 **Brief Title:** Effects Of Isometric Muscle Training On Shoulder Pain, Function And Performance In Bowlers **Official Title:** Effects Of Isometric Muscle Training On Shoulder Pain, Function And Performance In Bowlers #### Organization Study ID Info **ID:** REC/01834 Sheeraz Ali Shaikh #### Organization **Class:** OTHER **Full Name:** Riphah International University ### Status Module #### Completion Date **Date:** 2024-09-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-26 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-19 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### 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:** True ### Description Module **Brief Summary:** Goal of this clinical trial is to determine whether Isometric muscle training decrease pain improve function and enhance performance. Does Isometric exercise improve pain function and performance in bowlers? Researcher will compare the Isometric muscle training with Traditional therapy to examine that isometric exercise work on pain function and performance. Participants will receive isometric exercises for three days in week and will be followed up after two weeks total four weeks of trial(experimental group). Participants will receive traditional physical therapy treatment three days of week and followed up after two weeks total four weeks of trail (contril group) **Detailed Description:** This research is critical for addressing a common health concern and providing evidence-based recommendations for a potentially effective and accessible intervention that can significantly enhance the quality of life and performance of individuals dealing with shoulder pain. Thesis will benefit the bowlers by increasing their performance by enhancing accuracy, speed and consistency and over all shoulder health. Because shoulder discomfort is so common and has such a detrimental influence on everyday activities and performance, research on how isometric muscle training affects shoulder pain, function, and performance is crucial. In a variety of settings, isometric training has demonstrated promise in enhancing musculoskeletal function and pain management; however, its precise influence on shoulder-related problems is yet unknown. ### Conditions Module **Conditions:** - Shoulder Pain **Keywords:** - Isometric - Shoulder Pain - Bowlers - Performance ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Group 1 Experimental Group 2 Control ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The Isometric Exercise Program which comprises targeted exercises for declining pain, improving function and performance, exercises were focused only on shoulder flexion, extension, abduction, adduction, internal rotation and external rotation. Exercises were performed via Thera Bands, free weights and resistance. Each repetition was of 10 to 15 seconds and 10 to 15 number of repetition total of three sets according to FITT formula. Under the supervision of a therapist, these exercises were performed three times each week. Every training session lasts 35 to 40 minutes, with a 5-minute warm-up and a 5-minute cool-down in between. Instruction in the correct form and technique was provided to participants throughout the intervention, and their development was closely evaluated to guarantee safety and effectiveness. Total duration of 35 to 40-minute session three sessions per week total four weeks of intervention, reading will be taken on baseline and after 2nd week and 4th week. **Intervention Names:** - Diagnostic Test: Isometric Exercises **Label:** Effects Of Isometric Muscle Training On Shoulder Pain, Function And Performance In Bowlers **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** (control group) in this group participants will receive Traditional Physical therapy **Label:** Control Group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Effects Of Isometric Muscle Training On Shoulder Pain, Function And Performance In Bowlers **Description:** Isometric External Rotation (Perform isometric external rotation exercises with a resistance band to strengthen the rotator cuff.) Hold each contraction for 10-15 seconds. Isometric Internal Rotation (Hold each contraction for 10-15 seconds) Isometric Abduction (Supraspinatus). ( each contraction for 10 -15 sec) 10 repetition 3 sets Isometric Adduction (Subscapularis) Overhead Isometric Holds (Hold each contraction for 15-20 seconds) Isometric Shoulder External Rotation Against Resistance: (Hold each contraction for 15-20 seconds) Isometric Shoulder Press (Hold each contraction for 15-20 seconds) 15 to 20 repetitions 4 sets Total duration of 30 to 35 minute session three sessions per week total four weeks of intervention, reading will be taken on baseline and after 2nd week and 4th week **Name:** Isometric Exercises **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** The DASH questionnaire consists of 30 questions concerning upper limb function and symptoms. Patients figure out their ability to carry out each activity or the degree of their symptoms on a scale from 1 (no difficulty or no symptoms) to 5 (unable to perform the activity or vigorous symptoms). The results are then transformed into a standardized score, ranging from 0 to 100, with higher scores indicating more disabilities **Measure:** Disability of Arm Hand and Shoulder (DASH) **Time Frame:** 4th weeks #### Secondary Outcomes **Description:** It is used to assess weakness and also useful in identifying actual weakness from imbalance or inadequate endurance. It may be referred to as motor testing, muscular strength grading, manual muscle testing, or any other synonym **Measure:** Manual Muscle Testing **Time Frame:** 4th week **Description:** A VAS consists of a line, usually 10 cm long, with language anchors at each end, similar to an NRS (e.g., "no pain" on the far left and "the most intense pain imaginable" on the far right) **Measure:** Visual Analogue Scale VAS **Time Frame:** 4th week **Description:** Bowling speed test: A bowling speed app is a mobile application made to measure and analyze the speed of a thrown cricket ball **Measure:** Bowling Speed Test **Time Frame:** 4th week **Description:** (Cones, Target Set, Wicket to Wicket Bowling, and Video Analysis). **Measure:** Bowling Accuracy Test **Time Frame:** 4th week ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Active Male Bowlers * Age 18 - 30 * Pain that affects performance. Any level of pain that significantly affects a bowler's performance, accuracy, or consistency. * Pain with psychological impact. Pain that causes emotional distress, anxiety, or frustration. * Rotator Cuff pain. * Weekly 6 to 8 hour training Exclusion Criteria: * Other than bowlers **Maximum Age:** 30 Years **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Riafat Mehmood, PhD* **Phone:** 03132139115 **Role:** CONTACT #### Locations **Location 1:** **City:** Rawalpindi **Country:** Pakistan **Facility:** Elite Cricket Academy Shahbaz sharif sports complex **State:** Punjab **Zip:** 44000 #### Overall Officials **Official 1:** **Affiliation:** Riphah International University **Name:** Riafat Mehmood, PhD* **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Not sharing **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: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M21907 - Name: Shoulder Pain - Relevance: HIGH - As Found: Shoulder Pain - 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: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426862 **Brief Title:** Effects of Otago Exercise Program in Falls, Balance and Physical Performance in Stroke Patients **Official Title:** To Determine the Effects of the Otago Exercise Program on the Frequency of Falls, Balance Capabilities, and Overall Physical Performance in Stroke Patients. #### Organization Study ID Info **ID:** REC 01741 Muhammad Baqir #### Organization **Class:** OTHER **Full Name:** Riphah International University ### Status Module #### Completion Date **Date:** 2024-10-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-26 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-23 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### 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:** True ### Description Module **Brief Summary:** This study aims to determine the effects of the Otago Exercise Program (OEP) on falls and balance as well as overall physical performance. Participants will be divided into two groups; control and intervention group. It is a week-long study, the participants will be assessed through the Berg Balance Scale (BBS), Time Up and Go (TUG) and Fugl-Meyer Assessment (FMA). **Detailed Description:** The previous literature suggested that the Otago exercise showed significant improvement in terms of fall and balance. Most of the Studies were conducted on the elderly population but limited studies are available regarding stroke. This study will look at the effect of Otago exercise on stroke patients. The Otago exercise consists of 17 exercises; strengthening and balancing exercises. The participants will receive Otago exercise and routine physiotherapy treatment for six weeks. The participants will go through three assessments; Baseline Assessment, After 3 weeks assessment and final assessment. For association, a mixed method ANOVA test will be used. ### Conditions Module **Conditions:** - Stroke **Keywords:** - Stroke - Cardiovascular Attack - Otago Exercise Program - Berg Balance Scale - Time Up & Go Test - Fugl-Meyer Assessment ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The interventional group will receive both treatment routine physiotherapy and the Otago exercise program (OEP). The OEP is the exercise designed for strength and balance to improve mobility, functional balance and walking. The exercises included in this protocol are 17: strength, balance and walking. The participants will receive this protocol with 10 repetitions while the interval between exercises will not be fixed; patients will be given ample time to relax and recuperate before beginning another exercise, 3 times a week for six weeks and the time duration will be 30 to 45 minutes. The exercises will be progressively administered weekly. **Intervention Names:** - Other: Otago Exercise Program - Other: Control Group **Label:** Interventional Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The control group will receive routine treatment of physiotherapy for strokes like strengthening of upper and lower limb muscles (knee flexor, hip adductor and ankle dorsiflexor), stretching (hip abductors and ankle plantar flexor), postural awareness, gait and balance training like static and dynamic. The participants will be assessed through baseline assessment. **Intervention Names:** - Other: Control Group **Label:** Control group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Interventional Group **Description:** Otago exercise program Strengthening Exercise Knee extensor, Hip adductors, heel and toe raising Balance exercise Sit to stand, Knee bending, one leg standing, tandem stance, side walk, walk and turn around, tandem walk, backward walk, heel and toe walk, stair climbing **Name:** Otago Exercise Program **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Control group - Interventional Group **Description:** Routine physiotherapy like strengthening, stretching, postural awareness, gait and balance training. **Name:** Control Group **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The BBS was used to assess the quantitative measure of balance and fall risk among the older population through direct observation of their performance. The 14 items scale of total scoring 56 and each item has a scaling of 0 to 4. The scoring up to 0 to 20 represents impaired balance, 21 to 40 indicate acceptable while \>40 represent good balance. **Measure:** Berg Balance Scale **Time Frame:** Baseline **Description:** The BBS was used to assess the quantitative measure of balance and fall risk among the older population through direct observation of their performance. The 14 items scale of total scoring 56 and each item has a scaling of 0 to 4. The scoring up to 0 to 20 represents impaired balance, 21 to 40 indicate acceptable while \>40 represent good balance. **Measure:** Berg Balance Scale **Time Frame:** After 3 weeks **Description:** The BBS was used to assess the quantitative measure of balance and fall risk among the older population through direct observation of their performance. The 14 items scale of total scoring 56 and each item has a scaling of 0 to 4. The scoring up to 0 to 20 represents impaired balance, 21 to 40 indicate acceptable while \>40 represent good balance. **Measure:** Berg Balance Scale **Time Frame:** After 6 weeks **Description:** The TUG test was used to assess the functional mobility of the participants. The gait and balance maneuvers used in daily life are attributed to functional mobility. The participants were required to stand up, walk away through 3 meters or 10 feet and turn back to sit in the chair at starting. The individuals who cover the distance in \>20 seconds are considered as dependent in their activities while those who complete the task in \<20 sec indicate independence in ADLs. **Measure:** Time Up & Go Test **Time Frame:** Baseline **Description:** The TUG test was used to assess the functional mobility of the participants. The gait and balance maneuvers used in daily life are attributed to functional mobility. The participants were required to stand up, walk away through 3 meters or 10 feet and turn back to sit in the chair at starting. The individuals who cover the distance in \>20 seconds are considered as dependent in their activities while those who complete the task in \<20 sec indicate independence in ADLs. **Measure:** Time Up & Go Test **Time Frame:** After 3 weeks **Description:** The TUG test was used to assess the functional mobility of the participants. The gait and balance maneuvers used in daily life are attributed to functional mobility. The participants were required to stand up, walk away through 3 meters or 10 feet and turn back to sit in the chair at starting. The individuals who cover the distance in \>20 seconds are considered as dependent in their activities while those who complete the task in \<20 sec indicate independence in ADLs. **Measure:** Time Up & Go Test **Time Frame:** After 6 weeks **Description:** Motor impairment is the most common complication of stroke; it was measured by FMA quantitatively. The scale is divided into 5 domains; sensory \& motor function, balance, joint range of motion and joint pain. Each domain has a scale of 0 to 2 score while the total scoring of the scale is 226 score. **Measure:** Fugl-Meyer Assessment **Time Frame:** Baseline **Description:** Motor impairment is the most common complication of stroke; it was measured by FMA quantitatively. The scale is divided into 5 domains; sensory \& motor function, balance, joint range of motion and joint pain. Each domain has a scale of 0 to 2 score while the total scoring of the scale is 226 score. **Measure:** Fugl-Meyer Assessment **Time Frame:** After 3 weeks **Description:** Motor impairment is the most common complication of stroke; it was measured by FMA quantitatively. The scale is divided into 5 domains; sensory \& motor function, balance, joint range of motion and joint pain. Each domain has a scale of 0 to 2 score while the total scoring of the scale is 226 score. **Measure:** Fugl-Meyer Assessment **Time Frame:** After 6 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Ischemic or hemorrhagic stroke * Medically stable patients with acute to subacute level of stroke recovery (\< 6 month). * Patients 40 plus age * Berg balance scale \<45 and \>20 score * TUG test scoring \>20 sec Exclusion Criteria: * Participants having cognition problem or language barrier * Physical disability (fracture or amputation) other than stroke * Previous surgery 6 weeks * Cardiovascular and pulmonary disease **Minimum Age:** 40 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Muhammad Baqir, MS **Phone:** +923129008037 **Role:** CONTACT #### Locations **Location 1:** **City:** Peshawar **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Imran Amjad, Phd - **Phone:** +92 332 4390125 - **Role:** CONTACT **Country:** Pakistan **Facility:** Muhammad Baqir **State:** KPK **Status:** RECRUITING **Zip:** 25000 #### Overall Officials **Official 1:** **Affiliation:** Riphah International University **Name:** IMRAN AMJAD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002561 - Term: Cerebrovascular Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M22306 - Name: Stroke - Relevance: HIGH - As Found: Stroke - ID: M5810 - Name: Cerebrovascular Disorders - 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: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000020521 - Term: Stroke ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426849 **Brief Title:** Effects of Liuzijue Exercise Versus Tai Chi Chuan Exercise in Asthma **Official Title:** Effects of Liuzijue Exercise Versus Tai Chi Chuan Exercise in Improving Dyspnea Index and Pulmonary Function in Patients With Asthma #### Organization Study ID Info **ID:** Maria Akbar #### Organization **Class:** OTHER **Full Name:** Riphah International University ### Status Module #### Completion Date **Date:** 2024-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### 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:** True ### Description Module **Brief Summary:** To analyze either Liuzijue exercise or Tai Chi Chuan exercise is effective in improving dyspnea index and pulmonary function in patients with asthma. In the general population, the rate of asthma is increasing day by day because of environmental and occupational risk factors which is becoming a burden. It causes shortness of breath, decreases lung volume, and disturbs quality of life. This study aims to improve dyspnea index, lung volume and quality of life of the patients with asthma. **Detailed Description:** Liuzijue Exercise is the most popular exercise in ancient Chinese literature which is compiled by the Chinese Qigong Management Centre. Liuzijue exercise includes inhalation and exhalation through various mouth patterns to manage and control the rise and fall of the breath in the body. It is performed by delivering 6 distinct sounds, ("xū", "hē", "hū", "sī", "chuī", and "xī") through termination along with comparing body activities. It is very helpful to improve pulmonary functions, exercise capacity, and quality of life of patients with pulmonary disease. Liuzijue exercise takes on the backward abdominal breathing technique joined with physical exercises, which can practice the diaphragm and chest auxiliary respiratory muscles. Hence, the patient's breathing time is extended, and the breathing profundity increments. To accomplish the reason for expanding the gas exchange rate of the lungs and enhancing the lung capacity. Tai Chi Chuan is a traditional Chinese Exercise that is significant in improving the pulmonary functions of asthmatic patients. Tai Chi (10 forms of yang style ) significantly improves the exercise capacity of patients with lung disease. Tai Chi seems to have physiologic and psychosocial benefits and appears to be protected and viable in advancing balance control, adaptability, and cardiovascular fitness for older adults. ### Conditions Module **Conditions:** - Asthma **Keywords:** - Liuzijue exercise - Tai Chi Chuan exercise - Dyspnea Index - Pulmonary Function - Asthma ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** LiuzijueExercise will be performed by delivering 6 distinct sounds,("xū", "hē", "hū", "sī", "chuī", and "xī") through termination along with comparing body activities. **Intervention Names:** - Other: Liuzijue Exercise **Label:** GROUP A **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 10 FORM OF YANG NG STYLE Tai Chi Chuan Exercise that combines deep diaphragmatic breathing and relaxation with many fundamental postures. **Intervention Names:** - Other: Tai Chi Chuan Exercise **Label:** GROUP B **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - GROUP A **Description:** LiuzijueExercise includes inhalation and exhalation through various mouth patterns to manage and control the rise and fall of the breath in the body. It is performed by delivering 6 distinct sounds, (xū,hē, hū sī, chuī, and xī) through termination along with comparing body activities. The following are 6-8 vital parts of body movements: 1. Swaying and twisting 2. Hip rotations 3. Arm movements 4. Knee bends 5. Foot pivots 6. Spine elongation 7. Hand gestures 8. Breath synchronization Frequency: 1 session per day for a week Intensity:In first week 1 set of Luizijue exercise will be performed then progressively increase to 4 sets till 6th week . Total Time for Session; 40 minutes Warm-up Time: 10 minutes with pursed lip breathing Cool Down Time: 10 minutes with upper body gentle stretching. Exercise Duration: 20 minutes for Luizijue Exercise. **Name:** Liuzijue Exercise **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - GROUP B **Description:** Tai Chi Chuan Exercise combines deep diaphragmatic breathing and relaxation with many fundamental postures. Names of the 10 Movements in Sequence 1. Commencing Form 2. Repulsing the Monkey 3. Brush Knee 4. Parting the Horse's Mane 5. Cloud Hands 6. Golden Cockerel Standing on the Left, then the Right 7. Kick Out Right, Kick Out Left 8. Grasping the Bird's Tail 9. Cross Hands or Embrace the Tiger 10. Closing Form Frequency: 3 sessions / week Intensity: Initially each posture will be performed 3 times then progressively leads to 6 or 10 reps according to patient tolorance. Total Time for Session; 40 minutes Warm-up Time: 10 minutes with pursed lip breathing Cool Down Time: 10 minutes with upper body gentle stretching. Exercise Duration: 20 minutes for Tai Chi Chuan Exercise. **Name:** Tai Chi Chuan Exercise **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** From baseline till 2nd, 4th, and 6th week measured throug Modified Medical Research Council (mMRC) dyspnoea scale. It is a self-rating scale to quantify the level of incapacity that breathlessness presents on everyday activity on a scale from Grade 0 to 4. Grade 0: No shortness of breath besides on exhausting activity Grade1: Breathlessness while hustling fair and square or strolling along a slight slope Grade 2: Strolls more slow than individuals of same age fair and square in light of shortness of breath or needs to stop to take breath while strolling at their own speed fair and square Grade 3: Stop for breath subsequent to strolling ∼100 m or following couple of moments fair and square. Grade 4: Excessively breathless to take off from the house, or breathless while dressing or stripping down **Measure:** Dyspnea index **Time Frame:** 6 weeks **Description:** Changes from the Baseline, the digital spirometer is used in the clinical setting to analyze **Measure:** Forced Expiratory Volume in 1 second (FEV1) **Time Frame:** 6 weeks #### Secondary Outcomes **Description:** From baseline till 6th week measured through Asthma Control Questionnaire that individuals answer in regards to the recurrence of asthma symptoms over 6 weeks. Each answer has a numeric value. The asthmatic individual adds their score to decide their degree of asthma symptoms control. Score ranges from 5 to 25. A score 20 to 25 indicate well controlled asthma while score ranges between 5 to 6 indicated poor controlled asthma. **Measure:** Asthma Quality of life **Time Frame:** 6 Weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Diagnosed case of Asthma for last 6 months Patients with mild to moderate asthma On spirometry FEV1/FVC ratio less than 70% MRC- Grade 2 and 3 Exclusion Criteria: Refusal to consent. Unstable vitals. Diagnosed with COPD, pulmonary edema, acute or chronic pneumonia or other lung disease. Untreated Hypertension. Diagnosed Tumor. Patient with Stroke and other neurological conditions. Patient with active Tuberculosis or other infectious disease. Patients with history of heart failure or any other cardiovascular condition **Maximum Age:** 40 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Mehwish Waseem, MSPT-CPPT **Phone:** 0331-5309015 **Role:** CONTACT #### Locations **Location 1:** **City:** Chichawatni **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Mehwish Waseem, MSPT-CPPT - **Phone:** 0331-5309015 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Maria Akbar, MSPT-CPPT* - **Phone:** 0345-5024803 - **Role:** CONTACT **Country:** Pakistan **Facility:** Tehsil Headquarter Hospital **State:** Punjab **Status:** RECRUITING **Zip:** 57200 #### Overall Officials **Official 1:** **Affiliation:** Riphah International University **Name:** Mehwish Waseem, MSPT-CPPT **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001982 - Term: Bronchial Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000008171 - Term: Lung Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M7591 - Name: Dyspnea - Relevance: LOW - As Found: Unknown - ID: M4556 - Name: Asthma - Relevance: HIGH - As Found: Asthma - ID: M5258 - Name: Bronchial Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001249 - Term: Asthma ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426836 **Acronym:** PADECMO **Brief Title:** Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation (PADECMO) **Official Title:** Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation #### Organization Study ID Info **ID:** EC 2015/0529 #### Organization **Class:** OTHER **Full Name:** University Hospital, Ghent ### Status Module #### Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2016-08-19 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2022-05-13 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Ghent #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Pharmacokinetics of antibiotics in critically ill neonates, infants and children on extracorporeal membrane oxygenation (ECMO). **Detailed Description:** The study will investigate whether - with the current dosing regimens of meropenem, piperacillin-tazobactam, amoxicillin-clavulanate, cephazolin, vancomycin, amikacin, teicoplanin and ciprofloxacin - pharmacodynamic targets are attained in a national multicentric clinical setting in pediatric patients on ECMO. ### Conditions Module **Conditions:** - Pharmacokinetics - Amoxicillin-clavulanate - Piperacillin-tazobactam - Meropenem - Cefazolin - Teicoplanin - Vancomycin - Ciprofloxacin - Amikacin ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients receiving amoxicillin-clavulanate as part of routine clinical care. Study procedure: blood sampling **Intervention Names:** - Other: Amoxicillin-clavulanate **Label:** Amoxicillin-clavulanate **Type:** OTHER #### Arm Group 2 **Description:** Patients receiving piperacillin-tazobactam as part of routine clinical care. Study procedure: blood sampling **Intervention Names:** - Other: Piperacillin-tazobactam **Label:** Piperacillin-tazobactam **Type:** OTHER #### Arm Group 3 **Description:** Patients receiving meropenem as part of routine clinical care. Study procedure: blood sampling **Intervention Names:** - Other: Meropenem **Label:** Meropenem **Type:** OTHER #### Arm Group 4 **Description:** Patients receiving cefazolin as part of routine clinical care. Study procedure: blood sampling **Intervention Names:** - Other: Cefazolin **Label:** Cefazolin **Type:** OTHER #### Arm Group 5 **Description:** Patients receiving vancomycin as part of routine clinical care. Study procedure: blood sampling **Intervention Names:** - Other: Vancomycin **Label:** Vancomycin **Type:** OTHER #### Arm Group 6 **Description:** Patients receiving teicoplanin as part of routine clinical care. Study procedure: blood sampling **Intervention Names:** - Other: Teicoplanin **Label:** Teicoplanin **Type:** OTHER #### Arm Group 7 **Description:** Patients receiving ciprofloxacin as part of routine clinical care. Study procedure: blood sampling **Intervention Names:** - Other: Ciprofloxacin **Label:** Ciprofloxacin **Type:** OTHER #### Arm Group 8 **Description:** Patients receiving amikacin as part of routine clinical care. Study procedure: blood sampling **Intervention Names:** - Other: Amikacin **Label:** Amikacin **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Amoxicillin-clavulanate **Description:** blood sampling in patients receiving amoxicillin-clavulanate as part of routine clinical care **Name:** Amoxicillin-clavulanate **Other Names:** - Blood sampling **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Piperacillin-tazobactam **Description:** blood sampling in patients receiving piperacillin-tazobactam as part of routine clinical care. **Name:** Piperacillin-tazobactam **Other Names:** - Blood sampling **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Meropenem **Description:** blood sampling in patients receiving meropenem as part of routine clinical care. **Name:** Meropenem **Other Names:** - Blood sampling **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - Cefazolin **Description:** blood sampling in patients receiving cefazolin as part of routine clinical care. **Name:** Cefazolin **Other Names:** - Blood sampling **Type:** OTHER #### Intervention 5 **Arm Group Labels:** - Vancomycin **Description:** blood sampling in patients receiving vancomycin as part of routine clinical care. **Name:** Vancomycin **Other Names:** - Blood sampling **Type:** OTHER #### Intervention 6 **Arm Group Labels:** - Teicoplanin **Description:** blood sampling in patients receiving teicoplanin as part of routine clinical care. **Name:** Teicoplanin **Other Names:** - Blood sampling **Type:** OTHER #### Intervention 7 **Arm Group Labels:** - Ciprofloxacin **Description:** blood sampling and urine sampling in patients receiving ciprofloxacin as part of routine clinical care. **Name:** Ciprofloxacin **Other Names:** - Blood sampling **Type:** OTHER #### Intervention 8 **Arm Group Labels:** - Amikacin **Description:** blood sampling in patients receiving amikacin as part of routine clinical care. **Name:** Amikacin **Other Names:** - Blood sampling **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** % of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in steady-state conditions **Measure:** Amoxicillin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism **Time Frame:** up to 1 month **Description:** % of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in steady-state conditions **Measure:** Cefazolin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism **Time Frame:** up to 1 month **Description:** % of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in steady-state conditions **Measure:** Meropenem: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism **Time Frame:** up to 1 month **Description:** % of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in steady-state conditions **Measure:** Piperacillin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism **Time Frame:** up to 1 month **Description:** % of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens before or after extracorporeal membrane oxygenation in steady-state conditions **Measure:** Amoxicillin, piperacillin, meropenem, cefazolin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism **Time Frame:** up to 1 month **Description:** % of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens before or after extracorporeal membrane oxygenation in steady-state conditions **Measure:** Cefazolin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism **Time Frame:** up to 1 month **Description:** % of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens before or after extracorporeal membrane oxygenation in steady-state conditions **Measure:** Meropenem: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism **Time Frame:** up to 1 month **Description:** % of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens before or after extracorporeal membrane oxygenation in steady-state conditions **Measure:** Piperacillin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism **Time Frame:** up to 1 month **Description:** % of patients for whom a fAUC/MIC target\>86 is achieved with the current dosing regimen off extracorporeal membrane oxygenation in steady-state conditions **Measure:** Ciprofloxacin: probability of target attainment with the target being the free Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration ratio (fAUC/MIC) **Time Frame:** up to 1 month **Description:** % of patients in whom a AUC/MIC target 400-600 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions **Measure:** Vancomycin: probability of target attainment with the target being the Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration (AUC/MIC) **Time Frame:** up to 1 month **Description:** % of patients in whom a trough concentration between 20 to 30 mg/L is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions **Measure:** Teicoplanin: probability of target attainment with the target being a mimimal trough concentration **Time Frame:** up to 1 month **Description:** % of patients in whom an AUC/MIC of 900 is achieved with the current dosing regimen before or after extracorporeal membrane oxygenation in steady-state conditions **Measure:** for teicoplanin: probability of target attainment with the target being an Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration Ratio (AUC/MIC) **Time Frame:** up to 1 month **Description:** % of patients in whom a target peak/MIC ratio of 8 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions **Measure:** for amikacin: probability of target attainment with the target being a peak concentration over Minimal Inhibitory Concentration ratio (peak/MIC) **Time Frame:** up to 1 month **Description:** % of patients in whom the threshold for toxicity concentration\>5 mg/L is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions **Measure:** Amikacin: probability of toxicity threshold attainment with a target being a minimal trough concentration **Time Frame:** up to 1 month **Description:** % of patients in whom the threshold for toxicity concentration\>5 mg/L is achieved with the current dosing regimen before or after extracorporeal membrane oxygenation in steady-state conditions **Measure:** Amikacin: probability of toxicity threshold attainment with a target being a minimal trough concentration **Time Frame:** up to 1 month **Description:** % of patients in whom a target fAUC/MIC ratio of 399 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions **Measure:** Amikacin: probability of target attainment with the target being a free Area-under-the-Concentration-Time Curve over Minimal Inhibitory Concentration ratio (AUC/MIC) **Time Frame:** July 2026 **Description:** % of patients in whom a target fAUC/MIC ratio of 399 is achieved with the current dosing regimen before or after extracorporeal membrane oxygenation in steady-state conditions **Measure:** Amikacin: probability of target attainment with the target being a free Area-under-the-Concentration-Time Curve over Minimal Inhibitory Concentration ratio (AUC/MIC) **Time Frame:** July 2026 #### Secondary Outcomes **Description:** The impact of demographic, clinical characteristics and ECMO equipment characteristics on the risk of underdosing and overdosing will be investigated. The pharmacokinetic/pharmacodynamic target that is used is a percentage of time during which the unbound concentration remains above the Minimal Inhibitory Concentration (MIC) of the micro-organism of at least 50% and a maximum concentration of 10 x MIC **Measure:** Risk factors for underdosing during extracorporeal membrane oxygenation for beta-lactam antibiotics **Time Frame:** up to 1 month **Description:** The impact of demographic, clinical characteristics and ECMO equipment characteristics on the risk of underdosing and overdosing of ciprofloxacin will be investigated. The pharmacokinetic/pharmacodynamic target that is used is a free Area-under the concentration-Time Curve of 86 **Measure:** Risk factors for underdosing during extracorporeal membrane oxygenation for ciprofloxacin **Time Frame:** up to 1 month **Description:** The impact of demographic, clinical characteristics and ECMO equipment characteristics on the risk of underdosing and overdosing of vancomycin will be investigated. The pharmacokinetic/pharmacodynamic target that is used is a free Area-under the concentration-Time Curve of 200 to 300 **Measure:** Risk factors for under-and overdosing during extracorporeal membrane oxygenation for vancomycin **Time Frame:** up to 1 month **Description:** The impact of demographic, clinical characteristics and ECMO equipment characteristics on the risk of underdosing and overdosing of teicoplanin will be investigated. The pharmacokinetic/pharmacodynamic target that is used is an Area-under the concentration-Time Curve of 900 **Measure:** Risk factors for underdosing during extracorporeal membrane oxygenation for teicoplanin **Time Frame:** up to 1 month **Description:** The impact of demographic, clinical characteristics and ECMO equipment characteristics on the risk of underdosing and overdosing of amikacin will be investigated. The pharmacokinetic/pharmacodynamic target that is used is a peak over Minimal Inhibitory Concentration Ratio of 8 to 10, trough concentration below 5 mg/L and Area under the Concentration Time Curve/MIC\>399 **Measure:** Risk factors for under-and overdosing during extracorporeal membrane oxygenation for amikacin **Time Frame:** up to 1 month **Description:** % of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in first dose conditions **Measure:** Beta-lactam antibiotics (amoxicillin, piperacillin, meropenem, cefazolin): probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) **Time Frame:** up to 1 month **Description:** % of patients for whom a fAUC/MIC target\>86 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in first-dose conditions **Measure:** Ciprofloxacin: probability of target attainment with the target being the free Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration ratio (fAUC/MIC) **Time Frame:** up to 1 month **Description:** % of patients in whom a AUC/MIC target 400-600 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in first-dose conditions **Measure:** Vancomycin: probability of target attainment with the target being the Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration (AUC/MIC) **Time Frame:** up to 1 month **Description:** % of patients in whom a trough concentration between 20 to 30 mg/L is achieved with the current dosing regimen on extracorporeal membrane oxygenation in first-dose conditions **Measure:** Teicoplanin: probability of target attainment with the target being a mimimal trough concentration **Time Frame:** up to 1 month **Description:** % of patients in whom a target peak/MIC ratio of 8 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in first-dose conditions **Measure:** Amikacin: probability of target attainment with the target being a peak concentration over Minimal Inhibitory Concentration ratio (peak/MIC) **Time Frame:** up to 1 month **Description:** % of patients in whom the threshold for toxicity concentration\>5 mg/L is achieved with the current dosing regimen on extracorporeal membrane oxygenation in first-dose conditions **Measure:** Amikacin: probability of toxicity threshold attainment with a target being a minimal trough concentration **Time Frame:** up to 1 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients admitted to the pediatric intensive care unit or cardiac intensive care unit * patient age : 1,8 kg-15 years * patient receiving antibiotic treatment (piperacillin-tazobactam, meropenem, amoxicillin-clavulanate, cephazolin, vancomycin, teicoplanin, ciprofloxacin, amikacin) * intra-arterial or intravenous access other than the drug infusion line available for blood sampling (arterial line is preferred) * extracorporeal membrane oxygenation circuit Exclusion Criteria: * no catheter in place for blood sampling * absence of parental/patient consent * known hypersensitivity to beta-lactam antibiotics and ciprofloxacin **Maximum Age:** 15 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Pieter De Cock, PharmD **Phone:** +32 9 332 29 69 **Role:** CONTACT #### Locations **Location 1:** **City:** Brussel **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Biarent Dominique - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Vens Daphne - **Role:** CONTACT **Country:** Belgium **Facility:** Queen Fabiola Children's University Hospital **Status:** RECRUITING **Zip:** 1020 **Location 2:** **City:** Ghent **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Pieter De Cock - **Role:** CONTACT **Country:** Belgium **Facility:** University Hospital **Status:** RECRUITING **Zip:** 9000 **Location 3:** **City:** Leuven **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Debaveye Yves - **Role:** CONTACT **Country:** Belgium **Facility:** Universitair hospital **Status:** RECRUITING **Zip:** 3000 #### Overall Officials **Official 1:** **Affiliation:** University Hospital, Ghent **Name:** Annick de Jaeger, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000059005 - Term: Topoisomerase II Inhibitors - ID: D000059003 - Term: Topoisomerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents - ID: D000065609 - Term: Cytochrome P-450 CYP1A2 Inhibitors - ID: D000065607 - Term: Cytochrome P-450 Enzyme Inhibitors - ID: D000065093 - Term: beta-Lactamase Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents ### Intervention Browse Module - Browse Leaves - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M17388 - Name: Vancomycin - Relevance: HIGH - As Found: Pattern - ID: M3995 - Name: Amoxicillin - Relevance: HIGH - As Found: Prostate Cancer - ID: M6176 - Name: Ciprofloxacin - Relevance: HIGH - As Found: Higher - ID: M1889 - Name: Meropenem - Relevance: HIGH - As Found: Excision - ID: M5687 - Name: Cefazolin - Relevance: HIGH - As Found: Tunnel - ID: M1938 - Name: Tazobactam - Relevance: HIGH - As Found: Tocilizumab - ID: M13772 - Name: Piperacillin - Relevance: HIGH - As Found: Prompt - ID: M21710 - Name: Clavulanic Acid - Relevance: HIGH - As Found: Nanoparticle - ID: M3924 - Name: Amikacin - Relevance: HIGH - As Found: Triamcinolone acetonide - ID: M1885 - Name: Piperacillin, Tazobactam Drug Combination - Relevance: HIGH - As Found: Fellow - ID: M21845 - Name: Amoxicillin-Potassium Clavulanate Combination - Relevance: HIGH - As Found: Bisphosphonate - ID: M19621 - Name: Teicoplanin - Relevance: HIGH - As Found: Intracytoplasmic Sperm Injection - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M6204 - Name: Clavulanic Acids - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M30537 - Name: Cytochrome P-450 Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M30450 - Name: beta-Lactamase Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000658 - Term: Amoxicillin - ID: D000014640 - Term: Vancomycin - ID: D000002939 - Term: Ciprofloxacin - ID: D000077731 - Term: Meropenem - ID: D000002437 - Term: Cefazolin - ID: D000078142 - Term: Tazobactam - ID: D000010878 - Term: Piperacillin - ID: D000019818 - Term: Clavulanic Acid - ID: D000000583 - Term: Amikacin - ID: D000077725 - Term: Piperacillin, Tazobactam Drug Combination - ID: D000019980 - Term: Amoxicillin-Potassium Clavulanate Combination - ID: D000017334 - Term: Teicoplanin ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426823 **Acronym:** GA-17b **Brief Title:** The Role of GIP in Postprandial Splanchnic Blood Flow Distribution and Metabolism in Patients With Type 2 Diabetes **Official Title:** The Role of GIP in Postprandial Splanchnic Blood Flow Distribution and Metabolism in Patients With Type 2 Diabetes #### Organization Study ID Info **ID:** GA-17b #### Organization **Class:** OTHER **Full Name:** University of Copenhagen ### Status Module #### Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07 **Type:** ESTIMATED #### Start Date **Date:** 2023-11-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Rigshospitalet, Denmark #### Lead Sponsor **Class:** OTHER **Name:** University of Copenhagen #### 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 project will describe the mechanisms of action and the relative contributions of GIP to changes in gastrointestinal blood flow induced by oral glucose and endogenous GIP with the use of a receptor antagonists GIP(3-30)NH2 in patients with type 2 diabetes. **Detailed Description:** Each participant will attend four independent randomised experimental days in the MRI-scanner with intravenous infusion (hormone/placebo) and oral ingestion (glucose/water): An intravenous infusion of saline or GIP(3-30)NH2 starts at time point -20 minutes.The infusions are combined with an oral glucose tolerance test (75 gram of glucose dissolved in 250 ml water ingested orally) at time point 0 minutes on two of the experimental days (with and without GIP(3-30)NH2). MRI measurements are repeatedly performed and blood samples are drawn to be analysed for endocrine responses from the intestines, pancreas, and bones. ### Conditions Module **Conditions:** - Blood Flow **Keywords:** - Gut hormones - GIP - Physiology - Type 2 diabetes ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** Single blind, placebo controlled, randomized, crossover study ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Saline infusion, oral water ingestion **Intervention Names:** - Other: Saline / placebo **Label:** Saline and oral water (SAL-WAT) **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** Saline infusion, oral glucose ingestion **Intervention Names:** - Other: Saline / placebo **Label:** Saline infusion and oral glucose ingestion (SAL-GLU) **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** GIPR antagonist infusion, oral water ingestion **Intervention Names:** - Other: GIPR antagonist / study tool **Label:** GIP(3-30)NH2 infusion and oral water ingestion (GIA-WAT) **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** GIPR antagonist infusion, oral glucose ingestion **Intervention Names:** - Other: GIPR antagonist / study tool **Label:** GIP(3-30)NH2 infusion and oral glucose ingestion (GIA-GLU) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Saline and oral water (SAL-WAT) - Saline infusion and oral glucose ingestion (SAL-GLU) **Description:** NaCl (9 mg/ml) **Name:** Saline / placebo **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - GIP(3-30)NH2 infusion and oral glucose ingestion (GIA-GLU) - GIP(3-30)NH2 infusion and oral water ingestion (GIA-WAT) **Description:** GIP(3-30)NH2 **Name:** GIPR antagonist / study tool **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Measued with phase-contrast MRI in ml/min **Measure:** Redistribution of splanchnic blood flow in the vessel mesenteric superior artery (functional MRI) **Time Frame:** 80 minutes #### Secondary Outcomes **Description:** Radioimmuno assay on plasma blood sample (pmol/L) **Measure:** GIP levels **Time Frame:** 80 minutes **Description:** Radioimmuno assay on plasma blood sample (nmol/L) **Measure:** GIP(3-30)NH2 levels **Time Frame:** 80 minutes **Description:** Bedside measurement of whole blood sample (mmol/L) **Measure:** Glucose **Time Frame:** 80 minutes **Description:** Electrochemiluminescence immunoassay of plasma blood sample (pmol/L) **Measure:** C-peptide **Time Frame:** 80 minutes **Description:** Electrochemiluminescence immunoassay of plasma blood sample (pmol/L) **Measure:** Insulin **Time Frame:** 80 minutes **Description:** Radioimmuno assay on plasma blood samples (pmol/L) **Measure:** Glucagon **Time Frame:** 80 minutes **Description:** Measued with phase-contrast MRI in ml/min **Measure:** Blood flow in portal vein **Time Frame:** 80 minutes **Description:** Measued with phase-contrast MRI in ml/min **Measure:** Blood flow in coeliac trunc **Time Frame:** 80 minutes **Description:** Measued with phase-contrast MRI in ml/min **Measure:** Blood flow in hepatic artery **Time Frame:** 80 minutes ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Type 2 diabetes * BMI 20-35 kg/m\^2 * Age 20-80 Exclusion Criteria: * Not MRI-compatible implants * Claustrophobia * Abnormal kidney or liver function * Anemia * Planned weight loss or change in diet * Hypertension * Other conditions that could be expected to affect the primary or secondary outcomes **Maximum Age:** 80 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Lærke S Gasbjerg, MD PhD **Phone:** 25346894 **Phone Ext:** +45 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Rasmus S Rasmussen, Cand.scient. **Phone:** 50534173 **Phone Ext:** +45 **Role:** CONTACT #### Locations **Location 1:** **City:** Copenhagen **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Lærke S Gasbjerg - **Role:** CONTACT **Country:** Denmark **Facility:** Rigshospitalet **Status:** RECRUITING **Zip:** 2200 ### IPD Sharing Statement Module **Description:** Will share upon requests **IPD Sharing:** YES ## Document Section ### Large Document Module #### Large Docs - Date: 2024-05-17 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 1602889 - Type Abbrev: Prot_SAP - Upload Date: 2024-05-17T06:14 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003920 - Term: Diabetes Mellitus - 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: LOW - As Found: Unknown - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: HIGH - As Found: Type 2 Diabetes - 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: D000003924 - Term: Diabetes Mellitus, Type 2 ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents ### Intervention Browse Module - Browse Leaves - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M11449 - Name: Mechlorethamine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426810 **Brief Title:** Electrosurgical Bipolar Systems Versus Conventional Electrocautery After SLNBx **Official Title:** A Prospective Randomized Study Comparing Electrosurgical Bipolar Systems Versus Conventional Electrocautery After Sentinel Lymph Node Biopsy in Obese or Preoperative Chemotherapy Treated Breast Cancer Patients #### Organization Study ID Info **ID:** 10-2024-18 #### Organization **Class:** OTHER **Full Name:** SMG-SNU Boramae Medical Center ### Status Module #### Completion Date **Date:** 2027-04-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-04-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-07 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** SMG-SNU Boramae Medical Center #### Responsible Party **Investigator Affiliation:** SMG-SNU Boramae Medical Center **Investigator Full Name:** Jong-Ho Cheun **Investigator Title:** Clinical Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The efficacy of electrosurgical bipolar systems in axillary lymph node dissection for breast cancer surgery is well known. In this study, the investigators aim to determine whether using electrosurgical bipolar systems helps reduce seroma formation in high-risk patients undergoing sentinel lymph node biopsy (SLNB) for breast cancer surgery. The investigators will focus on patients who are expected to experience high drainage output after SLNB, especially those who are obese (BMI\>25) or have undergone preoperative chemotherapy. **Detailed Description:** The most common complications of breast cancer surgery are lymphorrhea and seroma. Seroma increases the length of hospital stay, the duration of outpatient treatment, and patient discomfort. Persistent seroma can lead to re-hospitalization due to wound infection caused by repeated aspirations. Seroma generally occurs in 10% to 85% of cases after breast cancer surgery. Risk factors associated with seroma or lymphorrhea identified in previous studies include age over 60, high BMI, tumor size, preoperative chemotherapy, extent of breast tissue resection, number of lymph nodes removed, and number of lymph node metastases. Efforts to reduce seroma after breast cancer surgery include meticulous techniques such as sharp dissection, the use of monopolar energy devices, and ligation of blood vessels and lymphatics. Recently, the bipolar energy sealing system has been increasingly used. LigaSure, which uses electric energy and pressure to denature collagen and elastin in tissue, has been shown to reduce surgical time and medical costs compared to traditional clamp-and-tie methods and advanced sealing systems in various surgeries, including breast cancer. In breast cancer surgery, using a electrosurgical bipolar systems for ligating blood vessels and lymph nodes has several potential advantages. Traditional ligation using sutures or monopolar energy devices can be influenced by surgical technique and has drawbacks such as thermal injury to surrounding tissue. In contrast, the bipolar energy sealer applies both electric energy and pressure simultaneously, minimizing thermal injury to surrounding tissue while ensuring permanent vessel and lymphatic ligation. A 2008 prospective study showed that using bipolar energy sealers in axillary dissection allowed for earlier removal of drains compared to conventional methods. Other studies have shown less blood loss, lower drainage output, and shorter hospital stays during surgery. Recent research has also reported new applications of bipolar energy sealers in skin-sparing mastectomy, indicating active use in breast surgery overseas. A study conducted at Severance Hospital in South Korea found that using bipolar energy sealers reduced drainage. However, most of these studies were conducted abroad with a small number of reported cases, and the results mainly concern axillary lymph node dissection (ALND), which is where seroma is most often formed. With the decreasing trend of ALND due to advances in preoperative chemotherapy and radiotherapy, there is a lack of studies on whether using electrosurgical bipolar systems helps reduce seroma formation after sentinel lymph node biopsy. ### Conditions Module **Conditions:** - Breast Cancer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Study participants using a electrosurgical bipolar energy system will undergo sentinel lymph node biopsy using only LigaSure during the surgery. **Intervention Names:** - Device: Electrosurgical bipolar system (LigaSure) **Label:** Electrosurgical bipolar systems group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Study participants using a conventional electrocautery will undergo sentinel lymph node biopsy using conventional bovie electrocautery during the surgery. **Label:** Conventional electrocautery group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Electrosurgical bipolar systems group **Description:** Study participants using a electrosurgical bipolar energy system will undergo sentinel lymph node biopsy using only LigaSure during the surgery. **Name:** Electrosurgical bipolar system (LigaSure) **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Total drainage amount from axilla after surgery (ml) **Measure:** Drainage amount **Time Frame:** Up to four weeks #### Secondary Outcomes **Description:** Total drainage amount from axilla before discharge (ml) **Measure:** Drainage amount during admission **Time Frame:** Up to one week **Description:** Operation time during axillar surgery (min) **Measure:** Operation time **Time Frame:** Up to 2 hours **Description:** Complications of axilla **Measure:** Complication **Time Frame:** At one month of surgery **Description:** Days before drain removal (days) **Measure:** Draine removal days **Time Frame:** Up to two weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Women aged 20-80 * Candidates for breast-conserving surgery and axillary sentinel lymph node biopsy * BMI over 25 or those who have received preoperative chemotherapy * Overall performance status of Eastern Cooperative Oncology Group (ECOG) 0-2 * Participants who understand the study contents and can provide written consent * Participants without evidence of distant metastasis Exclusion Criteria: * Those with suspected axillary lymph node enlargement or metastasis on preoperative imaging (breast MRI, chest CT, breast ultrasound) * Among patients who had confirmed lymph node metastasis before neoadjuvant chemotherapy, whose preopreative image showed residual disease at axillary lymph node * Those planning for mastectomy * Those planning for axillary lymph node dissection without SLNBx * Male breast cancer patients * Patients with bilateral breast cancer * Illiterate individuals, foreigners, or others who cannot read or understand the consent form * Individuals who voluntarily decide not to participate in the study or do not sign the consent form * Those judged by the researcher to be inappropriate for participation in this study * Study participants who did not have a drain inserted in the surgical area * If the randomized device is not used due to surgical room conditions (e.g., unavailability due to other emergency surgeries, device malfunction) and another device is substituted **Maximum Age:** 80 Years **Minimum Age:** 20 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jong-Ho Cheun, M.S. **Phone:** +82-10-8754-3054 **Role:** CONTACT #### Locations **Location 1:** **City:** Seoul **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jong-Ho Cheun, M.S. - **Phone:** +82-10-8754-3054 - **Role:** CONTACT **Country:** Korea, Republic of **Facility:** SMG-SNU Boramae medical center **State:** Dongjak-gu **Status:** RECRUITING **Zip:** 07061 #### Overall Officials **Official 1:** **Affiliation:** SMG-SNU Boramae Medical Center **Name:** Jong-Ho Cheun, M.S. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** van Bemmel AJ, van de Velde CJ, Schmitz RF, Liefers GJ. Prevention of seroma formation after axillary dissection in breast cancer: a systematic review. Eur J Surg Oncol. 2011 Oct;37(10):829-35. doi: 10.1016/j.ejso.2011.04.012. Epub 2011 Aug 17. **PMID:** 21849243 **Citation:** Manouras A, Markogiannakis H, Genetzakis M, Filippakis GM, Lagoudianakis EE, Kafiri G, Filis K, Zografos GC. Modified radical mastectomy with axillary dissection using the electrothermal bipolar vessel sealing system. Arch Surg. 2008 Jun;143(6):575-80; discussion 581. doi: 10.1001/archsurg.143.6.575. **PMID:** 18559751 **Citation:** Nespoli L, Antolini L, Stucchi C, Nespoli A, Valsecchi MG, Gianotti L. Axillary lymphadenectomy for breast cancer. A randomized controlled trial comparing a bipolar vessel sealing system to the conventional technique. Breast. 2012 Dec;21(6):739-45. doi: 10.1016/j.breast.2012.08.003. Epub 2012 Sep 7. **PMID:** 22959311 **Citation:** Cortadellas T, Cordoba O, Espinosa-Bravo M, Mendoza-Santin C, Rodriguez-Fernandez J, Esgueva A, Alvarez-Vinuesa M, Rubio IT, Xercavins J. Electrothermal bipolar vessel sealing system in axillary dissection: a prospective randomized clinical study. Int J Surg. 2011;9(8):636-40. doi: 10.1016/j.ijsu.2011.08.002. Epub 2011 Sep 10. **PMID:** 21925293 **Citation:** Miyagi K, Rossi SH, Malata CM, Forouhi P. Novel use of LigaSure Impact electrosurgical bipolar vessel sealing system in skin-sparing mastectomy. J Plast Reconstr Aesthet Surg. 2015 Jun;68(6):e126-8. doi: 10.1016/j.bjps.2015.01.005. Epub 2015 Jan 26. No abstract available. **PMID:** 25682592 **Citation:** Park HS, Lee J, Kim JY, Park JM, Kwon Y. A Prospective Randomized Study to Compare Postoperative Drainage After Mastectomy Using Electrosurgical Bipolar Systems and Conventional Electro-Cautery. J Breast Cancer. 2022 Aug;25(4):307-317. doi: 10.4048/jbc.2022.25.e29. Epub 2022 Jun 27. **PMID:** 35914746 ## Document Section ### Large Document Module #### Large Docs - Date: 2024-04-19 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 153614 - Type Abbrev: Prot_SAP - Upload Date: 2024-05-17T07:38 ## 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 ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M12701 - Name: Obesity - 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 ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426797 **Brief Title:** Neoadjuvant Cadonilimab Combined With Anlotinib in Locally Advanced Resectable Esophageal Squamous Cell Carcinoma **Official Title:** Safety and Efficacy of Cadonilimab Combined With Anlotinib in Neoadjuvant Treatment of Locally Advanced Resectable Esophageal Squamous Cell Carcinoma: a Single Arm, Phase II Study #### Organization Study ID Info **ID:** AK104-IIT-C-N1-0104 #### Organization **Class:** OTHER **Full Name:** Peking University People's Hospital ### Status Module #### Completion Date **Date:** 2027-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Akeso Pharmaceuticals, Inc. #### Lead Sponsor **Class:** OTHER **Name:** Peking University People's Hospital #### Responsible Party **Investigator Affiliation:** Peking University People's Hospital **Investigator Full Name:** Yang Fan, MD **Investigator Title:** Professor of Thoracic Surgery **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to learn if cadonilimab combined with anlotinib can be a safe and effective neoadjuvant therapy in patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC). The main questions it aims to answer are: What level of pathological complete response (pCR) rate can be achieved with this neoadjuvant regimen? Is this neoadjuvant regimen safe enough with acceptable toxicity? Participants will: Receive cadonilimab (10mg/Kg, ivgtt, d1) and anlotinib (12mg, P.O., d1-d14) on a 21-day regimen for 3 cycles. Undertake radical resection of ESCC after neoadjuvant therapy if there is no surgical contraindication. Accept an follow-up for 2 years after surgery. **Detailed Description:** Esophageal cancer has a high incidence in China, among which esophageal squamous cell carcinoma is the most common. Neoadjuvant chemoradiotherapy combined with surgery is currently the recommended treatment modality for locally advanced esophageal cancer, but the side effects of chemoradiotherapy are serious, which increases the risk of surgery. Immune checkpoint inhibitors have made significant progress in the field of cancer treatment in recent years, and have now become an important treatment method for advanced and metastatic esophageal cancer. Several trials on neoadjuvant immuno-chemotherapy demonstrated better outcomes with acceptable toxicity compared to traditional chemoradiotherapy. Cadonilimab is a dual immune antibody drug comprised of PD-1 antibody and CTLA-4 antibody, which has the anti-tumor effect of two immune checkpoint pathways at the same time. On the other hand, angiogenesis plays a vital role in the growth and metastasis of tumors, and anti-angiogenic drugs have become an important part of cancer treatment. Anlotinib is an oral, small molecule anti-angiogenic targeted agent that has been approved for use in a variety of cancer treatments. This study plans to conduct a prospective study of cadonilimab combined with anlotinib in the neoadjuvant treatment of resectable esophageal squamous cell carcinoma, and aims to explore the efficacy and safety of this neoadjuvant regimen that avoids chemoradiotherapy in locally advanced resectable esophageal squamous cell carcinoma. ### Conditions Module **Conditions:** - Locally Advanced Esophageal Squamous Cell Carcinoma **Keywords:** - esophageal squamous cell carcinoma - neoadjuvant immunotherapy - pathological complete response ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Patients with locally advanced resectable esophageal squamous cell carcinoma ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 25 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with locally advanced esophageal squamous cell carcinoma **Intervention Names:** - Drug: Cadonilimab plus anlotinib **Label:** locally advanced ESCC **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - locally advanced ESCC **Description:** cadonilimab (10mg/Kg, ivgtt, d1) and anlotinib (12mg, P.O., d1-d14) on a 21-day regimen for 3 cycles **Name:** Cadonilimab plus anlotinib **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Pathological complete response (pCR) rate is defined as the percentage of participants with no residual viable tumor in primary tumor site or lymph nodes as evaluated by blinded independent pathological review (BIPR). **Measure:** Pathological Complete Response (pCR) Rate **Time Frame:** Within 1 week after surgery #### Secondary Outcomes **Description:** Major pathological response (MPR) rate is defined as the percentage of participants with less than or equal to 10% of residual viable tumor in primary tumor site or lymph nodes as evaluated by blinded independent pathological review (BIPR). Viable tumors in situ carcinoma should not be included in MPR calculation. **Measure:** Major Pathological Response (MPR) Rate **Time Frame:** Within 1 week after surgery **Description:** Objective response rate (ORR) is defined as the Percentage of participants achieving complete response (CR) or partial response (PR) in all patients with measurable disease at baseline, as assessed by the investigator according to RECIST version 1.1. **Measure:** Objective Response Rate (ORR) **Time Frame:** Within 1 week before surgery **Description:** The incidence and severity of treatment emergent adverse events (including adverse events, serious adverse events and immune-related adverse events) among all participants. **Measure:** Treatment Emergent Adverse Events (TEAE) **Time Frame:** Up to 24 months after participation **Description:** EFS is defined as the time from participation to any of the following events: progression of disease, recurrence disease, or death due to any cause. Progression/recurrence will be assessed either by biopsy assessed by local pathologist or by investigator-assessed imaging using RECIST version 1.1. **Measure:** Event-free Survival (EFS) **Time Frame:** Up to 24 months after participation ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Able to provide written informed consent and understand and agree to comply with the requirements of this study as well as the assessment schedule. 2. Be at least 18 years of age on the date of signing the ICF. 3. Histopathologically confirmed esophageal squamous cell carcinoma: the clinical stage is T1-2N1-3M0, T2 (diameter≥3 cm) N0M0 or T3-4aN0-3M0 (stage II-IVA), and the staging should be based on the AJCC 8th edition esophageal cancer staging system. 4. Patients are asked to provide an archival tumor tissue sample (FFPE tissue block or approximately 15 \[≥6\] freshly cut unstained FFPE sections) and a pathology report of this baseline sample. If no archival sample is available or the sample is not available, a biopsy sample is requested at baseline. 5. Prior to study enrollment, patients are evaluated by thoracic surgeon in charge of surgery to verify that they meet the study requirements for R0 resection with radical curative intent. 6. Cardiac and pulmonary function is good, and surgical resection for curative purposes is confirmed, and cardiopulmonary function tests and respiratory or cardiology consultation can be completed if necessary. 7. Measurable disease as assessed by the investigator according to RECIST version 1.1. 8. Eligible for anlotinib treatment. 9. ECOG performance status ≤ 2 points. 10. ≤ 14 days prior to enrollment, the following laboratory test values during the screening period suggest that the patient has good organ function: * Patient has not had a blood transfusion or use of growth factor supportive therapy within ≤14 days prior to blood draw, when the following items are tested prior to enrollment: * Absolute neutrophil count ≥ 1.5 x 109/L * Platelet ≥ 75×109/L * Hemoglobin ≥ 90 g/L * Glomerular filtration rate (GFR) estimated by the Cooperative Equation for Epidemiology of Chronic Kidney Disease ≥45mL/min/1.73 m2. * Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) (total bilirubin must be \<3 ×ULN in patients with Gilbert's syndrome). * AST and ALT≤2.5 ×ULN. * Patients not receiving anticoagulant therapy: International normalized ratio or activated partial prothrombin time ≤ 1.5× ULN. 11. Females of childbearing potential must be willing to practice highly effective contraception for the duration of the study, and for ≥120 days after the last dose of cadonilimab or anlotinib, whichever occurs later, and have a negative urine or serum pregnancy test result within ≤7 days prior to enrollment. Exclusion Criteria: 1. Previous treatment for current esophageal cancer, including chemotherapy or radiotherapy. 2. Prior receipt of antibodies or drugs targeting immune checkpoint pathways, including but not limited to anti-cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4), anti-PD-1, and anti-PD-L1 therapeutic antibodies. 3. Patients with non-squamous cell carcinoma. 4. Presence of locally advanced, unresectable disease, regardless of disease stage and presence or absence of metastases (stage IV). 5. Active autoimmune disease or history of autoimmune disease that may recur. Note: Patients with the following conditions do not need to be excluded and can proceed for further enrollment screening: * Well-controlled type I diabetes * Hypothyroidism (as long as it is treated with hormone replacement therapy alone) * Well-controlled celiac disease * Skin conditions that do not require systemic treatment (e.g., vitiligo, psoriasis, alopecia) * Any other illness that is not expected to recur in the absence of an external trigger 6. Any active malignancy in the ≤ 2 years prior to enrollment, with the exception of the specific cancers studied in this study and cancers that have recured locally after radical therapy (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ). 7. Any condition requiring systemic treatment with corticosteroids (prednisone or equivalent\> 10 mg/day) or other immunosuppressive medications within ≤14 days prior to enrollment. Note: Patients with current or prior use of any of the following steroid regimens do not need to be excluded: * Adrenal replacement steroids (prednisone or equivalent\> 10 mg/day) * Topical, ocular, intra-articular, intranasal, or inhaled corticosteroids with very low systemic absorption * Short-term (≤7 days) prophylactic use of corticosteroids (e.g., contrast allergy) or for the treatment of non-autoimmune diseases (e.g., delayed-type hypersensitivity reactions caused by contact allergens) 8. Poorly controlled diabetes mellitus ≤ 14 days prior to enrollment, or abnormal laboratory test results of potassium, sodium, or corrected calcium \> grade 1 (regardless of standard medical management) or ≥ grade 3 hypoalbuminemia. 9. Has a history of interstitial lung disease, non-infectious pneumonitis, or poorly controlled diseases, including pulmonary fibrosis, acute lung disease, etc. 10. Severe chronic or active infection requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. Severe infection within 4 weeks prior to enrollment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia. 11. Known history of HIV virus infection. 12. Patients with untreated chronic hepatitis B or HBV carriers with hepatitis B virus (HBV) DNA ≥ 500 IU/mL, or patients with active hepatitis C virus (HCV) should be excluded. Note: Patients with inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B carriers (HBV DNA \< 500 IU/mL), and cured hepatitis C patients can be enrolled. 13. Any major surgical procedure requiring general anesthesia ≤ 28 days prior to enrollment. 14. Previous allogeneic stem cell transplantation or organ transplantation. 15. Any of the following cardiovascular risk factors: * Cardiogenic chest pain within 28 days prior to enrollment, defined as moderate pain with instrumental limitation of activities of daily living. * Symptomatic pulmonary embolism within 28 days prior to enrollment. * Any history of acute myocardial infarction within 6 months prior to enrollment. * Any history of heart failure consistent with New York Heart Association Classification Class III or IV≤ 6 months prior to enrollment. * Any ≥ grade 2 ventricular arrhythmic event within 6 months prior to enrollment (inclusive). * Any history of cerebrovascular accident within 6 months prior to enrollment. * Hypertension that remains uncontrolled with standard antihypertensive medication within 28 days prior to enrollment. * Syncope or seizures ≤ 28 days prior to enrollment. 16. History of severe allergic reaction to chimeric or humanized antibodies or fusion proteins. 17. Received any other chemotherapy, immunotherapy (e.g., interleukin, interferon, thymosin), or any investigational therapy during the study period. 18. Patients who have not returned to baseline or stable levels of toxic side effects (due to prior antineoplastic therapy) unless the AE is not considered to pose a safety risk (e.g., alopecia, neuropathy, and specific laboratory abnormalities). 19. Received a live vaccine ≤ 4 weeks prior to enrollment. Note: Seasonal influenza vaccines are usually inactivated and are therefore permitted. Intranasal vaccination is a live vaccine, so it is not allowed. 20. Has an underlying medical condition (including laboratory abnormalities) or alcohol/drug abuse or dependence that, in the opinion of the investigator, is detrimental to study drug administration or affects the interpretation of drug toxicity or adverse events, or in the judgment of the investigator that the patient's adherence during the study is not adequate that could affect compliance. 21. Participating in another therapeutic clinical study at the same time. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Fan Yang, M.D. **Phone:** +86-010-88326657 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Xiang Yan, M.D. **Phone:** +86-13581786750 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Peking University People's Hospital **Name:** Fan Yang, M.D. **Role:** STUDY_CHAIR ### 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: D000018307 - Term: Neoplasms, Squamous Cell - ID: D000004938 - Term: Esophageal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000004935 - Term: Esophageal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M5550 - Name: Carcinoma, Squamous Cell - Relevance: HIGH - As Found: Squamous Cell Carcinoma - ID: M1733 - Name: Esophageal Squamous Cell Carcinoma - Relevance: HIGH - As Found: Esophageal Squamous Cell 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: M20451 - Name: Neoplasms, Squamous Cell - Relevance: LOW - As Found: Unknown - ID: M8088 - Name: Esophageal 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: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8085 - Name: Esophageal Diseases - Relevance: LOW - As Found: Unknown - ID: T2141 - Name: Esophageal Cancer - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000002294 - Term: Carcinoma, Squamous Cell - ID: D000077277 - Term: Esophageal Squamous Cell Carcinoma ### 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: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426784 **Brief Title:** Perfusion Index as a Predictor of Hypotension Following Sub-arachnoid Block Among Patients Undergoing Lower Segment Caesarean Section **Official Title:** Perfusion Index as a Predictor of Hypotension Following Sub-arachnoid Block Among Patients Undergoing Lower Segment Caesarean Section #### Organization Study ID Info **ID:** F-5-2/2024(ERRB)/PIMS #### Organization **Class:** OTHER_GOV **Full Name:** Pakistan Institute of Medical Sciences ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-26 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-27 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Pakistan Institute of Medical Sciences #### Lead Sponsor **Class:** OTHER_GOV **Name:** Muhammad Haroon Anwar #### Responsible Party **Investigator Affiliation:** Pakistan Institute of Medical Sciences **Investigator Full Name:** Muhammad Haroon Anwar **Investigator Title:** Principal Investigator, Department of Anaesthesia and Critical Care Medicine **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** C-section is one of the commonly performed surgical procedures. During this surgical procedure the surgeon cuts into uterine cavity through abdominal wall and takes out the baby. This is done by by making the lower half body of the patient numb by injecting local anesthesia drugs into the space surrounding the spinal cord. This allows the mother to remain awake and immediately bond with the baby once it gets delivered. Also this technique provides effective pain relief both during and after the surgery. However like any other technique or drug it is associated with a number of side effects. The most important being fall in blood pressure. There are numerous ways to treat it. However if one is able to predict fall in blood pressure before administration of anesthetic technique one can easily prevent it. One of the recently discovered novel way to predict fall in blood pressure is Perfusion index which is calculated by Pulse oximeter. It is a device use to check amount of oxygen in blood and heart rate. Perfusion index refers to the total amount of blood present in the limbs of the person. Once we administer drug in the space surrounding the spinal cord the amount of blood in the limbs increases while the amount returning to heart decreases which ultimately results in less amount of blood being pumped out by heart resulting in fall in blood pressure. Therefore theoretically those individuals who have a high baseline Perfusion index will more likely to develop low blood pressure. This study aims to identify the cut off value of perfusion index to predict fall in blood pressure. **Detailed Description:** Spinal anesthesia is employed to provide excellent surgical conditions in case of C-Section. It is the anesthetic technique of choice among obstetric patients. However it is associated with sympathectomy which reduces the venous return and ultimately causes hypotension. This hypotension is mainly due to redistribution of blood volume to the peripheral compartment. Perfusion index which is measured by Pulse Oximetery is a ratio of pulsatile to non-pulsatile blood in the peripheral compartment of the body. As spinal anesthesia causes sympathectomy, peripheral blood volume increases. As a result perfusion index value should rise. This will then co-relate with hypotension. In simple terms those individuals who have a high baseline Perfusion index value will more likely to develop hypotension. This study aims to identify the baseline perfusion index value which co-relates with development of hypotension following sub-arachnoid block for C-section. ### Conditions Module **Conditions:** - Hypotension - Hypotension on Induction - Spinal Anesthetics Causing Adverse Effects in Therapeutic Use ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Pregnant patients having baseline perfusion index less than 3.5 will be enrolled into this group. **Label:** Low Perfusion index #### Arm Group 2 **Description:** Pregnant patients having baseline perfusion index ≥ 3.5 will be enrolled into this group. **Label:** High Perfusion index ### Outcomes Module #### Primary Outcomes **Description:** Number of episodes of hypotension among both groups will be compared. **Measure:** Incidence of hypotension **Time Frame:** Intra-operative peroid #### Secondary Outcomes **Description:** Sensitivity and specificity of baseline perfusion index to predict intra-operative hypotension following sub-arachnoid block **Measure:** Baseline perfusion index as a predictor of hypotension **Time Frame:** Intra operative peroid ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ASA class II and III * Elective LSCS under sub-arachnoid block * Age 18-35 years Exclusion Criteria: * Hypertensive disorders of pregnancy * Autonomic neuropathy * Fetal distress * NPO \>8h * Lack of maintenance fluid or oral clear fluid intake during NPO period. * BMI \> 35 kg/m2 * Patients requiring Vasopressor and Ionotropic support. **Gender Based:** True **Gender Description:** Pregnant females undergoing elective Lower segment caesarean section **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT **Study Population:** Pregnant females undergoing elective lower segment caesarean section under spinal anesthesia at Pakistan Institute of Medical sciences will be enrolled in the study. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Muhammad Haroon Anwar, MBBS **Phone:** +92-333-5236956 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Naheed Fatima, MBBS,FCPS **Phone:** +92-300-5236655 **Role:** CONTACT #### Locations **Location 1:** **City:** Islamabad **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Muhammad Haroon Anwar, MBBS - **Phone:** +92-333-5236956 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Naheed Fatima, MBBS,FCPS - **Phone:** +92-300-5236655 - **Role:** CONTACT ***Contact 3:*** - **Name:** Muhammad Haroon Anwar, MBBS - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Pakistan **Facility:** Deparment of Anesthesia and Critical Care Medicine, Pakistan Institute of Medical Sciences **State:** Federal **Status:** RECRUITING **Zip:** 44000 #### Overall Officials **Official 1:** **Affiliation:** Department of Anesthesia and Critical Care, Pakistan Institute of Medical Sciences, Islamabad **Name:** Muhammad Haroon Anwar, MBBS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Lal J, Bansal T, Bhardwaj S, Jain M, Singh AK. A study to evaluate perfusion index as a predictor of hypotension following spinal anesthesia for caesarean section. J Anaesthesiol Clin Pharmacol. 2022 Apr-Jun;38(2):294-299. doi: 10.4103/joacp.JOACP_385_20. Epub 2022 Jun 16. **PMID:** 36171921 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10072 - Name: Hypotension - Relevance: HIGH - As Found: Hypotension - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007022 - Term: Hypotension ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426771 **Acronym:** AMH **Brief Title:** Effect of Antimullerian Hormone Levels on the Inflammatory Index, Phytochemical Index and NRF Nutrient Density **Official Title:** Investigation of Dietary Inflammatory Index, Dietary Phytochemical Index and NRF Nutrient Density in Patients With High and Low Antimullerian Hormone Levels #### Organization Study ID Info **ID:** 02/10 28.02.2024 #### Organization **Class:** OTHER **Full Name:** Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital ### Status Module #### Completion Date **Date:** 2024-10-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-18 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital #### Responsible Party **Investigator Affiliation:** Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital **Investigator Full Name:** Mujde Can Ibanoglu **Investigator Title:** Assoc. Prof **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The aim of the study was to calculate the dietary inflammatory index, dietary phytochemical index and NRF nutrient density of the dietary pattern routinely consumed by women and to assess whether there is a difference between PCOS patients with high AMH levels and the group with low AMH levels. **Detailed Description:** There is currently growing interest in the relationship between lifestyle, reproductive health and fertility. Recent research emphasizes the influence of environmental and lifestyle factors such as stress, diet and nutritional status on reproductive health. Ovarian reserve refers to the number and quality of eggs and is an indicator of reproductive potential. Ovarian reserve is inversely proportional to the chronological age of the mother, which is the most important determinant of reproductive capacity and reproductive success. It has been shown that reproductive aging accelerates after the age of 35. Therefore, the assessment of ovarian reserve is an important step in both the evaluation and treatment of infertility. Markers of ovarian reserve include antral follicle count (AFC), which is determined by transvaginal ultrasound, and serum levels of various biomarkers such as anti-Müllerian hormone (AMH), follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol. Studies show that certain dietary patterns and the intake of certain nutrients are associated with endometriosis, ovarian reserve and egg quality, ovarian infertility and fertility. In addition, there is evidence that modifiable lifestyle factors, such as adherence to certain dietary habits and avoidance of environmental toxins, may also have positive effects on ovarian reserve. Recent studies have shown that women's nutritional status, body mass index and eating habits influence ovarian reserve. The Dietary Inflammatory Index (DII) is an index developed to assess the impact of general dietary habits on inflammation. It is known that the dietary inflammatory index is high in chronic diseases associated with inflammation. The Phytochemical Index is a calculation based on the consumption of fruits high in phytochemicals, all vegetables except potatoes, legumes, whole grains and whole grain-containing foods, and oilseeds that provides information about the level of phytochemicals in the diet. The NRF Nutrient Density Index is a continuous function and represents an arithmetic combination of weighted variables. In this continuous function algorithm, the negative part (foods that should be restricted) is subtracted from the positive part (foods that should be consumed). In the calculation phase of this model, foods were scored according to their nutrient content per 100 kcal and per serving size. By calculating the nutrient density of the food consumed, the quality of the person's diet can be determined. Based on this information, it was planned to compare these 3 nutritional indices in patients diagnosed with PCOS with an AMH level above 3.32 ng/ml, in the low ovarian reserve group without a PCOS diagnosis with an AMH level below 1.2 ng/ml and in normo-responder patients with an AMH level between these two values. ### Conditions Module **Conditions:** - AMH - Diet Habit - Ovarian Failure - Polycystic Ovary Syndrome **Keywords:** - NRF Nutrient Density Index - Dietary Inflammatory Index - Phytochemical Index - anti-Müllerian hormone ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 6 Months ### Arms Interventions Module #### Arm Group 1 **Description:** AMH levels: those with low AMH levels (\<1.2 ng/ml): 30 participants **Intervention Names:** - Behavioral: Dietary Inflammatory Index - Diagnostic Test: hormone profile **Label:** Low AMH Levels- #### Arm Group 2 **Description:** normal AMH levels (1.2-3.32 ng/ml): 30 participants **Intervention Names:** - Behavioral: Dietary Inflammatory Index - Diagnostic Test: hormone profile **Label:** Normal AMH levels- #### Arm Group 3 **Description:** high AMH levels (\>3.32 ng/ml): 30 Participants **Intervention Names:** - Behavioral: Dietary Inflammatory Index - Diagnostic Test: hormone profile **Label:** High AMH levels- ### Interventions #### Intervention 1 **Arm Group Labels:** - High AMH levels- - Low AMH Levels- - Normal AMH levels- **Description:** The aim of this study was to compare the dietary habits of patients with PCOS and an AMH value of \>3.32 ng/ml, of patients with low ovarian reserve without PCOS and an AMH value of less than 1.2 ng/ml and of patients with normal AMH values (between 1.2-3.32 ng/ml) according to Dietary Nutrient Density according to Dietary Inflammatory Index, Dietary Phytochemical Index and Nutrient Rich Food Index. **Name:** Dietary Inflammatory Index **Other Names:** - Dietary Phytochemical Index - Nutrient Rich Food Index **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - High AMH levels- - Low AMH Levels- - Normal AMH levels- **Description:** In the routine practice of the PCOS clinic, about 7 ml of blood is taken in a vacuum gel tube for hormonal and biochemical analysis by medical staff. The blood samples are centrifuged by the researchers at 1000xg for 20 minutes. In the next step, the supernatant part is separated and transferred to 3 mL Ependorfs. These samples are used to determine the levels of anti-Müllerian hormone (AMH), oestradiol, LH and FSH, which are routinely determined at the PCOS clinic. **Name:** hormone profile **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Patients with low, normal and high AMH values are examined for differences in the indices calculated according to nutrient density. **Measure:** AMH levels according to dietary indexes **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Between the ages of 18 and 40, * No underlying metabolic disease (type 2 diabetes, hypertension, diagnosed anemia), * Female patients with AMH levels in our hospital, * Participants attending the PCOS clinic and under the care of our hospital dietitian will be enrolled in the study. Exclusion Criteria: 1. Age \< 18 and \> 40 years; 2. Menopause, pregnancy or breastfeeding in the last 6 months; 3. Hyperandrogenism and/or biochemical hyperandrogenemia due to secondary causes, including congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, hyperprolactinemia, thyroid dysfunction, and adrenal disease), 4. Pre-existing systemic or psychiatric illnesses 5. Taking medication that affects carbohydrate or fat metabolism (contraceptive pills, metformin, antiepileptic drugs, antipsychotics, statins and fish oil); 6. Certain nutritional therapies or hypocaloric diet in the last three months; supplementation with antioxidants, vitamins or minerals; 7. Taking medications that can affect fluid balance, such as non-steroidal anti-inflammatory drugs, diuretics, etc. 8. Female patients with implanted pacemakers or defibrillators due to the theoretical possibility of impaired device activity. **Healthy Volunteers:** True **Maximum Age:** 40 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT **Study Population:** This study was designed as a cross-sectional cohort study including individuals who were followed up in the PCOS Clinic and dietetic department of Etlik Zübeyde Hanım Gynaecology Training and Research Hospital. Patients will be divided into 3 groups according to AMH value as those with low AMH value, those with normal AMH value and those with high AMH value (11). The study will include 90 individuals who agreed to be included in the study and accepted the consent form verbally and in writing. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Mujde Can Ibanoglu **Phone:** 05323089488 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Yaprak Engin-Ustun **Phone:** 05323089488 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Ankara Etlik Zubeyde Hanım Women's Health Training and Research Hospital, Ankara, Turkey. **Name:** Mujde Can Ibanoglu **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Lakoma K, Kukharuk O, Sliz D. The Influence of Metabolic Factors and Diet on Fertility. Nutrients. 2023 Feb 27;15(5):1180. doi: 10.3390/nu15051180. **PMID:** 36904180 **Citation:** Barrea L, Arnone A, Annunziata G, Muscogiuri G, Laudisio D, Salzano C, Pugliese G, Colao A, Savastano S. Adherence to the Mediterranean Diet, Dietary Patterns and Body Composition in Women with Polycystic Ovary Syndrome (PCOS). Nutrients. 2019 Sep 23;11(10):2278. doi: 10.3390/nu11102278. **PMID:** 31547562 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010048 - Term: Ovarian Cysts - ID: D000003560 - Term: Cysts - ID: D000009369 - Term: Neoplasms - ID: D000010049 - Term: Ovarian Diseases - ID: D000000291 - Term: Adnexal Diseases - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000091662 - Term: Genital Diseases - ID: D000006058 - Term: Gonadal Disorders - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M13970 - Name: Polycystic Ovary Syndrome - Relevance: HIGH - As Found: Polycystic Ovary Syndrome - ID: M6765 - Name: Cysts - Relevance: LOW - As Found: Unknown - ID: M12971 - Name: Ovarian Cysts - Relevance: LOW - As Found: Unknown - ID: M12972 - Name: Ovarian Diseases - Relevance: LOW - As Found: Unknown - ID: M3643 - Name: Adnexal Diseases - Relevance: LOW - As Found: Unknown - ID: M8943 - Name: Genital Diseases, Female - 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 - 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: M9163 - Name: Gonadal Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011085 - Term: Polycystic Ovary Syndrome ### Intervention Browse Module - Ancestors - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Repr - Name: Reproductive Control Agents ### Intervention Browse Module - Browse Leaves - ID: M8108 - Name: Estradiol - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: HIGH - As Found: Loss - ID: M266279 - Name: Estradiol 17 beta-cypionate - Relevance: LOW - As Found: Unknown - ID: M266280 - Name: Estradiol 3-benzoate - Relevance: LOW - As Found: Unknown - ID: M234941 - Name: Polyestradiol phosphate - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000006728 - Term: Hormones ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426758 **Brief Title:** Graves' Disease Induced by Epstein-Barr Virus Lytic Reactivation **Official Title:** The Morbidity of Graves' Disease and Recurrence Rate of Hyperthyroidism Due to Epstein-Barr Virus Lytic Reactivation #### Organization Study ID Info **ID:** NanjingMU2 #### Organization **Class:** OTHER **Full Name:** Nanjing Medical University ### Status Module #### Completion Date **Date:** 2027-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** National Natural Science Foundation of China #### Lead Sponsor **Class:** OTHER **Name:** Xiao-Ming Mao #### Responsible Party **Investigator Affiliation:** Nanjing Medical University **Investigator Full Name:** Xiao-Ming Mao **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:** Previous studies have proved that the lytic reactivation of latent Epstein-Barr virus (EBV) was significantly associated with the onset of Graves'disease (GD), however, the morbidity of GD and recurrence rate of hyperthyroidism after antithyroid drugs treatment due to lytic reactivation of EBV is not understood. We will recruit patients with newly diagnosed GD and recurrence of hyperthyroidism after antithyroid drugs treatment. In order to confirm lytic reactivation of EBV, the number of EBV DNA copies，mRNA and protein expression of immediate-early, early and late lytic EBV genes，EBV +TRAb+cells will be tested. The proportion of lytic reactivation of EBV in newly diagnosed GD and recurrence of hyperthyroidism was evaluated. **Detailed Description:** The lytic reactivation of latent EBV play importment roles in development of GD and recurrence rate of hyperthyroidism. The aim of this study is to evaluate the proportion of lytic reactivation of EBV in newly diagnosed GD and recurrence of hyperthyroidism. All patients satisfied the diagnostic criteria for GD. The diagnotic remission of hyperthyroidism was included of clinical symptoms and elevated FT3 and FT4, the patients who have been received antithyroid drugs (methimazole or propylthiouracil) titration treatment for 18 or more months and of antithyroid drugs titration treatment and withdrawal antithyroid drugs at least 3 months. The evaluation of lytic reactivation of latent EBV including EBV DNA copies，mRNA and protein expression of immediate-early, early and late lytic genes，and EBV +TRAb+cells. The EBV DNA copies was tested with PCR, mRNA and protein expression of immediate-early, early and late lytic EBV genes were analysed with RT-qPCR or Western blot and EBV +TRAb+cells were evaluated with flow cytometry. All statistical tests were performed using GraphPad Prism V8.0. ### Conditions Module **Conditions:** - Graves Disease - Graves' Disease in Remission - Epstein-Barr Virus **Keywords:** - Graves Disease - Relapse of hyperthyroidism - Epstein-Barr virus - Lytic reactivation - Morbidity ### Design Module #### Bio Spec **Description:** Following DNA isolation with a QIAamp DNA Blood Mini Kit, the number of EBV copies in PBMCs was detected using real-time PCR assay by means of the ISEX variant of the EBV PCR kit. The results are expressed in units of EBV DNA copies/µg of DNA, EBV DNA copies/mL of PBMCs suspension, and EBV DNAcopies/100,000 cells. Peripheral blood samples were collected from patients with GD and recurrence of hyperthyroidism.Total RNA was extracted from blood using the conventional TRIzol method. Reverse transcription was performed using PrimeScript RT Reagent Kit with cDNA Eraser for two-step reverse transcription polymerase chain reaction. **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** The GD patients with high number of EBV DNA copies, EBV +TRAb+cells and overexpression lytic genes are considered as lytic reactivation of EBV **Measure:** The incidence rate of GD and and recurrence of hyperthyroidism due to lytic reactivation of EBV **Time Frame:** 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * The clinical evaluation included patient history, physical examination, and thyroid ultrasonography. Laboratory and diagnostic testing included determination of serum levels of free thyroxine (FT4), T3 ( FT3), thyrotropin (TSH), TPOAb, TGAb, and serum levels of thyrotropin receptor antibody (TRAb). Exclusion Criteria: * Patients with subacute thyroiditis, hyperfunctioning thyroid nodules, iodine hyperthyroidism, drug-induced hyperthyroidism, or other causes of hyperthyroidism were also excluded. The exclusion criteria for both patients with GD included diabetes, infectious diseases, other chronic diseases, and cancer. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Newly diagnosed GD and recurrence of hyperthyroidism after antithyroid drugs treatment ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Xiao-Ming Mao, MD. **Phone:** +86-18951670295 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Guo-Qing Li, PhD. **Role:** CONTACT #### Locations **Location 1:** **City:** Nanjing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Xiao-Ming Mao, MD. - **Phone:** +86-18951670295 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Guo-Qing Li, PhD. - **Phone:** +86-15895915500 - **Role:** CONTACT **Country:** China **Facility:** Nanjing First Hospital, Nanjing Medical University **State:** Jiangsu **Zip:** 210006 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014777 - Term: Virus Diseases - ID: D000007239 - Term: Infections - ID: D000006566 - Term: Herpesviridae Infections - ID: D000004266 - Term: DNA Virus Infections - ID: D000014412 - Term: Tumor Virus Infections - ID: D000005094 - Term: Exophthalmos - ID: D000009916 - Term: Orbital Diseases - ID: D000005128 - Term: Eye Diseases - ID: D000006042 - Term: Goiter - ID: D000013959 - Term: Thyroid Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BC11 - Name: Eye Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M21881 - Name: Epstein-Barr Virus Infections - Relevance: HIGH - As Found: Epstein-Barr Virus - ID: M9214 - Name: Graves Disease - Relevance: HIGH - As Found: Graves' Disease - ID: M10031 - Name: Hyperthyroidism - Relevance: HIGH - As Found: Hyperthyroidism - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M9643 - Name: Herpesviridae Infections - Relevance: LOW - As Found: Unknown - ID: M7442 - Name: DNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M17162 - Name: Tumor Virus Infections - Relevance: LOW - As Found: Unknown - ID: M8237 - Name: Exophthalmos - Relevance: LOW - As Found: Unknown - ID: M12845 - Name: Orbital Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: M9147 - Name: Goiter - Relevance: LOW - As Found: Unknown - ID: M16718 - Name: Thyroid Diseases - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - 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 ### Condition Browse Module - Meshes - ID: D000020031 - Term: Epstein-Barr Virus Infections - ID: D000006111 - Term: Graves Disease - ID: D000006980 - Term: Hyperthyroidism ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426745 **Brief Title:** Split-dose Versus Single-dose Bowel Preparation for Colonoscopy **Official Title:** Split-dose Versus Single-dose Bowel Preparation for Colonoscopy #### Organization Study ID Info **ID:** PEG solution #### Organization **Class:** INDUSTRY **Full Name:** Egymedicalpedia ### Status Module #### Completion Date **Date:** 2023-12-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-10-25 **Type:** ACTUAL #### Start Date **Date:** 2022-11-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Egymedicalpedia #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Colonoscopy is the current standard method for evaluation of colonic disorders such as colorectal cancer, IBD, polyps, and other conditions. **Detailed Description:** Colonic cancers are a major concern in the Middle East and the world in general, and every institute has attempted to initiate various clinical and investigatory procedures to detect the disease early in its development. From 2005 till 2010 an audit conducted at the Royal Liverpool University revealed that out of 8910 colonoscopies, 693 were incomplete (7.8%), and for 25% of failure was because of inadequate bowel preparation. An adequate bowel preparation regimen is not only effective in cleansing the colon but should be well tolerated by patients. The polyethylene glycol (PEG) solution, an isosmotic non-absorbable polymer, is generally used for bowel preparation, because of its safety, effectiveness, and good tolerability. Quality of bowel cleansing depends not only on the formula used, but the preparation regimen also plays a role. Split dosing of the laxative offers, in general, better cleansing than a single dose preparation. A large survey was also done in the USA in 2018 and demonstrated that split dose treatment was more tolerable than single-dose treatment for bowel preparation. Also more recent study shows split-dose bowel preparation for colonoscopy with PEG is better than single-dose, in terms of adequate bowel preparation and polyp detection. On the other hand , a large randomized trial of PEG regimens show, low-volume same-day resulted in similar bowel cleanliness compared with high-volume or low-volume split-dosing. Willingness to repeat and tolerability were superior with low-volume same-day compared with high-volume split-dose and similar to low-volume split-dose. Another most recent one demonstrated that same-day morning PEG regimen can be considered an effective well-tolerated, and acceptable bowel preparation for colonoscopy. A same-day dose of bowel cleanser has several benefits compared with split-dose or previous-day dose: the fasting time is shorter and there is no sleep disturbance, which can be associated with split-dose or previous-day regimen. ### Conditions Module **Conditions:** - Colonic Cancer - Colonic Polyp - IBS - Irritable Bowel Syndrome ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 180 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** About 90 participants underwent Split-dose bowel preparation for colonoscopy **Intervention Names:** - Procedure: Bowel preparation **Label:** Split-dose bowel preparation **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** About 90 participants underwent single-dose bowel preparation for colonoscopy **Intervention Names:** - Procedure: Bowel preparation **Label:** single-dose bowel preparation **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Split-dose bowel preparation - single-dose bowel preparation **Description:** to compare bowel cleanliness, compliance, tolerability, and patient satisfaction of a single regimen versus a split regimen for colonoscopy. **Name:** Bowel preparation **Other Names:** - colonoscopy **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** to compare the efficacy of split-dose versus single morning administration of PEG solution for colon cleansing in patient undergoing colonoscopy using Boston Bowel Preparation Scale , and to assess the optimal preparation- to-colonoscopy (PC) interval . **Measure:** colon cleansing **Time Frame:** 2 hours before Bowel Preparation ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: - All patients undergoing elective colonoscopy Exclusion Criteria: * Presence of sever renal impairment. (Creatinine clearance \< 30 ml/min or patient on hemodialysis). * Sever congestive heart failure (NHYA III or IV). * Pregnant woman. * History of bowel obstruction or resection. * Known allergies to polyethylene glycol. * Refusal of consent for the study. * Signs of liver cell failure as ascites and hepatic encephalopathy. * Electrolytes disturbances **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Mansoura **Country:** Egypt **Facility:** Mansoura university Hospital #### Overall Officials **Official 1:** **Affiliation:** Internal Medicine Hepatology and Gastroenterology Faculty of Medicine - Mansoura University **Name:** Seham Mohammad Abd-AlAdl Seif, Professor **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** Hepatology and Gastroenterology Faculty of Medicine - Mansoura University **Name:** Hany Shabana, M.D **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003109 - Term: Colonic Diseases, Functional - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000007417 - Term: Intestinal Polyps - ID: D000011127 - Term: Polyps - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000015179 - Term: Colorectal Neoplasms - 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 ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC04 - Name: Neoplasms ### Condition Browse Module - Browse Leaves - ID: M14011 - Name: Polyps - Relevance: LOW - As Found: Unknown - ID: M6339 - Name: Colonic Polyps - Relevance: HIGH - As Found: Colonic Polyps - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M25118 - Name: Irritable Bowel Syndrome - Relevance: HIGH - As Found: Irritable Bowel Syndrome - ID: M6338 - Name: Colonic Neoplasms - Relevance: HIGH - As Found: Colonic Cancer - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M6337 - Name: Colonic Diseases, Functional - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M10451 - Name: Intestinal Polyps - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M17890 - Name: Colorectal Neoplasms - 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 ### Condition Browse Module - Meshes - ID: D000003110 - Term: Colonic Neoplasms - ID: D000043183 - Term: Irritable Bowel Syndrome - ID: D000003111 - Term: Colonic Polyps ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426732 **Brief Title:** The Trajectory of Blood Pressure During Pregnancy in Assisted Reproductive Females **Official Title:** The Trajectory of Blood Pressure During Pregnancy in Assisted Reproductive Females #### Organization Study ID Info **ID:** 2022-919 #### Organization **Class:** OTHER **Full Name:** The Second Hospital of Shandong University ### Status Module #### Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-18 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2022-11-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-18 **Study First Submit QC Date:** 2024-05-18 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The Second Hospital of Shandong University #### Responsible Party **Investigator Affiliation:** The Second Hospital of Shandong University **Investigator Full Name:** Linlin Cui **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The incidence of gestational hypertension and preeclampsia in the assisted reproductive technology population during pregnancy was significantly higher than that in the general normal pregnancy population. The use of assisted reproductive technology in this population due to infertility is often accompanied by many hypertension-related factors. We established a prospective cohort study based on assisted reproductive technology pregnancy population and natural pregnancy population. Through continuous monitoring of blood pressure changes and other risk factors during pregnancy in the two groups, we explored the trajectory trend and inflection point of assisted reproductive technology pregnancy population blood pressure during pregnancy. Through factor analysis, the risk factors of elevated blood pressure during pregnancy can be clearly identified, so as to carry out early intervention and strengthen the control of risk factors of elevated blood pressure in assisted reproductive technology population, in order to expect benign maternal and infant outcomes. ### Conditions Module **Conditions:** - Blood Pressure ### 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 **Label:** Natural pregnancy group #### Arm Group 2 **Label:** Assisted Reproductive Technology Group ### Outcomes Module #### Primary Outcomes **Description:** The Trajectory of Blood Pressure During Pregnancy in Assisted Reproductive Females **Measure:** The Trajectory of Blood Pressure During Pregnancy in Assisted Reproductive Females **Time Frame:** from pregnancy to delivery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: -Exposure group: Mother: Seen in the obstetrics department of our hospital and meet the following conditions at the same time: 1. Complete at least one cycle of IVF or ICSI, PGD or IVM treatment (including natural cycles); 2. Clinical pregnancy was obtained after treatment. Offspring: Offspring born after in vitro fertilization-embryo transfer technique. * Non-exposed group: Mother: A mother who conceived naturally. Offspring: 1) Offspring born by natural pregnancy. 2) Offspring born from natural pregnancy of exposed mothers. Exclusion Criteria: * Unwilling to participate in this research; * Unable to participate in this study due to special reasons, such as death, immigration, loss to follow-up; * Hereditary diseases, mental diseases, malignant tumors, pre-pregnancy hypertension, uterine malformations and other reproductive organ malformations; * Pregnant women who voluntarily terminate pregnancy due to non-preeclampsia factors; **Maximum Age:** 45 Years **Minimum Age:** 20 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT **Study Population:** collect sixty patients in each group ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Wenting Wang, M.D. Ph.D. **Phone:** +86 17660082326 **Role:** CONTACT #### Locations **Location 1:** **City:** Jinan **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** cui lin lin, doctor - **Phone:** 17660082326 - **Role:** CONTACT ***Contact 2:*** - **Name:** wang wen ting, doctor - **Phone:** 13188936075 - **Role:** CONTACT **Country:** China **Facility:** Cui linlin **Status:** RECRUITING ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426719 **Brief Title:** Efficiency of Using Osseodensification Protocol **Official Title:** Efficiency of Using Osseodensification Protocol for Alveolar Ridge Expansion in Edentulous Alveolar Ridges #### Organization Study ID Info **ID:** 28908210103756 #### Organization **Class:** OTHER **Full Name:** Cairo University ### Status Module #### Completion Date **Date:** 2024-02-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-18 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-01-20 **Type:** ACTUAL #### Start Date **Date:** 2022-05-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-18 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Cairo University #### Lead Sponsor **Class:** OTHER **Name:** Mohamed Magdy Mostafa Shehata #### Responsible Party **Investigator Affiliation:** Cairo University **Investigator Full Name:** Mohamed Magdy Mostafa Shehata **Investigator Title:** doctor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** the goal of this clinical trial is to learn if the new osseo-densification technique works to provide enough bone width and quality prior to implant placement in the upper jaw the main question it aims to answer is: Is the use of osseo-densification protocol better than the standard alveolar ridge widening techniques; regarding efficiency and comfort in obtaining sufficient alveolar ridge width in horizontally atrophic alveolar ridges? **Detailed Description:** a new osseo-densification protocol using specially designed Densah burs was compared to conventional hand Osteotome technique to test its efficiency in providing sufficient bone quantity and quality in cases of horizontally deficient maxillary edentulous alveolar ridge sites that require expansion prior to dental implant placement ### Conditions Module **Conditions:** - Alveolar Bone Resorption **Keywords:** - Densah burs - Osseodensification - OsseoHand Osteotomes - alveolar ridge wideninig ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** a new technique used to provide sufficient alveolar ridge width and enhance bone quality at horizontally deficient maxillary alveolar ridges prior to implant placement. the new technique uses specially designed burs called Densah burs that act by causeing bone compaction rather than bone removing from the osteotomy site ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 18 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** the group in which alveloalr ridge widening is done using densah burs, it is the study group **Intervention Names:** - Procedure: Alveolar ridge wideninig via applying osseodensification protocol using densah burs **Label:** intervention group osseodensification **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** the group in which alveolar ridge expansion is done using hand driven osteotomes . it is the conventional froup **Intervention Names:** - Procedure: Alveolar ridge widening via hand osteotomes **Label:** conventional osteotome group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - intervention group osseodensification **Description:** alveolar ridge expansion using densah burs in horizontally deficient maxillary alveolar ridges prior to dental implants insertion **Name:** Alveolar ridge wideninig via applying osseodensification protocol using densah burs **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - conventional osteotome group **Description:** Alveolar ridge expansion using hand driven osteotomes in horizontally deficient maxillary alveolar ridges prior to dental Implant insertion **Name:** Alveolar ridge widening via hand osteotomes **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** the amount of ridge width gain is measured both clinically via a caliber and radiographically on CBCT **Measure:** efficiency of ridge widening technique **Time Frame:** intraoperative and within 3 days post operative #### Secondary Outcomes **Description:** the primary stability of the inserted dental implant is measured via osstell device **Measure:** primary stability of implant **Time Frame:** intra-operative after dental implant placement **Description:** the time required for completion of the surgical procedure is measured in minutes using stop watch **Measure:** length of surgical procedure **Time Frame:** During surgery **Description:** the degree of pain or discomfort examined by the patient during the ridge widening procedure is recorded using a visual scale where 0 represents no pain while 1 minimum pain and 10 is maximum pain **Measure:** Value of pain **Time Frame:** Immediate post operative ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥18 years old. * In cases of an initial ridge width ≤ 5mm that contains ≤ 2mm of trabecular bone core. * Alveolar ridges with narrow crest and wider base. Exclusion Criteria: * Uncontrolled diabetic patients * Heavy Smokers * Patients suffering from osteoporosis * Patients receiving chemo or radio therapy * Patients suffering from bleeding disorders * Patients suffering from intraosseous lesions at the proposed site of implant * Patients with insufficient alveolar bone hight less than 10 mm. * Resorbed ridge with a narrow base. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Mohamed Magdy Mostafa shehata **Zip:** 11799 #### Overall Officials **Official 1:** **Affiliation:** Cairo University **Name:** Mohamed M Shehata **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** IDP will be shared with researchers and clinical investigators who require them for further systematic review or retrograde studies via contacting the principal investigator through email **Description:** all IPD that underlie results in a publication **Info Types:** - STUDY_PROTOCOL - SAP **IPD Sharing:** YES **Time Frame:** within 6 months from publication ### References Module #### References **Citation:** Tian JH, Neiva R, Coelho PG, Witek L, Tovar NM, Lo IC, Gil LF, Torroni A. Alveolar Ridge Expansion: Comparison of Osseodensification and Conventional Osteotome Techniques. J Craniofac Surg. 2019 Mar/Apr;30(2):607-610. doi: 10.1097/SCS.0000000000004956. **PMID:** 30507887 **Citation:** Bassetti MA, Bassetti RG, Bosshardt DD. The alveolar ridge splitting/expansion technique: a systematic review. Clin Oral Implants Res. 2016 Mar;27(3):310-24. doi: 10.1111/clr.12537. Epub 2015 Jan 14. **PMID:** 25586966 **Citation:** Jha N, Choi EH, Kaushik NK, Ryu JJ. Types of devices used in ridge split procedure for alveolar bone expansion: A systematic review. PLoS One. 2017 Jul 21;12(7):e0180342. doi: 10.1371/journal.pone.0180342. eCollection 2017. **PMID:** 28732054 **Citation:** Inchingolo AD, Inchingolo AM, Bordea IR, Xhajanka E, Romeo DM, Romeo M, Zappone CMF, Malcangi G, Scarano A, Lorusso F, Isacco CG, Marinelli G, Contaldo M, Ballini A, Inchingolo F, Dipalma G. The Effectiveness of Osseodensification Drilling Protocol for Implant Site Osteotomy: A Systematic Review of the Literature and Meta-Analysis. Materials (Basel). 2021 Feb 28;14(5):1147. doi: 10.3390/ma14051147. **PMID:** 33671038 **Citation:** Padhye NM, Padhye AM, Bhatavadekar NB. Osseodensification -- A systematic review and qualitative analysis of published literature. J Oral Biol Craniofac Res. 2020 Jan-Mar;10(1):375-380. doi: 10.1016/j.jobcr.2019.10.002. Epub 2019 Nov 2. **PMID:** 31737477 **Citation:** Witek L, Alifarag AM, Tovar N, Lopez CD, Gil LF, Gorbonosov M, Hannan K, Neiva R, Coelho PG. Osteogenic parameters surrounding trabecular tantalum metal implants in osteotomies prepared via osseodensification drilling. Med Oral Patol Oral Cir Bucal. 2019 Nov 1;24(6):e764-e769. doi: 10.4317/medoral.23108. **PMID:** 31655837 **Citation:** Starch-Jensen T, Becktor JP. Maxillary Alveolar Ridge Expansion with Split-Crest Technique Compared with Lateral Ridge Augmentation with Autogenous Bone Block Graft: a Systematic Review. J Oral Maxillofac Res. 2019 Dec 30;10(4):e2. doi: 10.5037/jomr.2019.10402. eCollection 2019 Oct-Dec. **PMID:** 32158526 **Citation:** Demetriades N, Park JI, Laskarides C. Alternative bone expansion technique for implant placement in atrophic edentulous maxilla and mandible. J Oral Implantol. 2011 Aug;37(4):463-71. doi: 10.1563/AAID-JOI-D-10-00028. Epub 2010 Jul 21. **PMID:** 20662673 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC07 - Name: Mouth and Tooth Diseases ### Condition Browse Module - Browse Leaves - ID: M5141 - Name: Bone Resorption - Relevance: HIGH - As Found: Bone Resorption - ID: M12026 - Name: Mouth, Edentulous - Relevance: LOW - As Found: Unknown - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001862 - Term: Bone Resorption ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426706 **Brief Title:** TPVB or SPSIPB in Pain Management After VATS **Official Title:** Paravertebral Block or Serratus Posterior Superior Intercostal Plane Block in Pain Management After Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Clinical Trial #### Organization Study ID Info **ID:** 2024.174.IRB1.019 #### Organization **Class:** OTHER **Full Name:** Koç University ### Status Module #### Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Koç University #### Responsible Party **Investigator Affiliation:** Koç University **Investigator Full Name:** Kamil Darcin **Investigator Title:** MD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to compare the analgesic efficacy of thoracal paravertebral block (TPVB) and serratus posterior superior intercostal plane block (SPSIPB) in patients undergoing video-assisted thoracoscopic surgery (VATS). The main questions it aims to answer are: How will the total perioperative opioid consumption of the patients receiving two different blocks change? How will TPVB and SPSIPB effect the patients' numeric rating scores for pain in the postoperative 24-hour period? How will TPVB and SPSIPB effect the incidence of opioid related side effects? Participants will be divided in two groups: TPVB group will receive a TPVB before the surgery. SPSIPB group will receive a SPSIPB nerve block before the surgery. Researchers will compare the results between the groups to see the postoperative effects concerning opioid consumption as well as the pain scores, respiratory parameters and opioid associated side effects. The hypothesis of this study is that participants receiving SPSIPB for VATS will have a less total opioid consumption 24 hours postoperatively. **Detailed Description:** Video-assisted thoracoscopic surgeries require a surgical incision of the lateral thoracic wall. In order to ease the postoperative pain of patients undergoing VATS, some regional anaesthesia techniques have been tried but there is no consensus on the best method. The gold standard peripheric nerve block is considered to be thoracal paravertebral block (TPVB). Recently, a new nerve block called serratus posterior superior intercostal plane block (SPSIPB) has been described. The anatomic and radiologic studies of SPSIPB suggest that the local anaesthetic distributes from C7 to T10 vertebrates, covering the surgical site of VATS. This study aims to compare the analgesic efficacy of TPVB and SPSIPB for VATS. The hypothesis is that participants receiving SPSIPB for VATS will have a less total opioid consumption 24 hours postoperatively. Also, the postoperative pain scores and opioid related side effects of the participants will be recorded. Participants will be divided in two groups. The group P will receive a TPVB preoperatively in the operating room. The group S will receive a SPSIPB preoperatively in the operating room. The participants will be followed 24 hours postoperatively and their total opioid consumption, numeric rating scores for pain, incidence of opioid related side effects will be recorded. Also the participants and the surgical teams perioperative pain related satisfaction will be evaluated. ### Conditions Module **Conditions:** - Video-assisted Thoracoscopic Surgery - Paravertebral Block - Serratus Posterior Superior Intercostal Plane Block - Regional Anesthesia Morbidity **Keywords:** - video-assisted thoracoscopic surgery - paravertebral block - serratus posterior superior intercostal plane block ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 44 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants who will be receiving a serratus posterior superior intercostal plane block **Intervention Names:** - Procedure: Serratus Posterior Superior Intercostal Plane Block **Label:** Group S **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants who will be receiving a thoracal paravertebral block **Intervention Names:** - Procedure: Paravertebral Block **Label:** Group P **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group S **Description:** Before the induction of general anesthesia, under aseptic conditions, serratus posterior superior intercostal plane block will be performed with a single dose of 30 ml of %0,25 bupivacaine with ultrasound guidance, by the senior anaesthesiologist. **Name:** Serratus Posterior Superior Intercostal Plane Block **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Group P **Description:** Before the induction of general anesthesia, under aseptic conditions, paravertebral block will be performed with a single dose of 30 ml of %0,25 bupivacaine with ultrasound guidance, by the senior anaesthesiologist. **Name:** Paravertebral Block **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** all consumed opioids will be converted in morphine equivalents and then added to reach the total dosage **Measure:** Total opioid consumption **Time Frame:** 24 hours post-surgery #### Secondary Outcomes **Description:** the scale between 0: no pain and 10:highes pain answered by the participants **Measure:** Numeric rating scale scores for pain **Time Frame:** 24 hours post-surgery **Description:** Nausea, vomiting, pruritis, respiratory depression assessed by yes/no questions **Measure:** Opioid related side effects **Time Frame:** 24 hours post-surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients between the age of 18-80 undergoing video-assisted thoracoscopic surgery Exclusion Criteria: * Allergy to local anaesthetics Chronic opioid use history Patients with psychiatric disorders Patients who are not open to communication Patients with chronic organ failure Patients that do not give consent Patients that need emergency surgery within the first 24 hours of the initial surgery **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:** Kamil Darçın, MD **Phone:** +90 505 589 50 99 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Yasemin Sincer, MD **Phone:** +90 531 204 08 34 **Role:** CONTACT #### Locations **Location 1:** **City:** İstanbul **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Kamil Darçın - **Phone:** +905055895099 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Yasemin Sincer - **Phone:** +90512040834 - **Role:** CONTACT ***Contact 3:*** - **Name:** Kamil Darçın - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Turkey **Facility:** Koc University **Status:** RECRUITING **Zip:** 34010 #### Overall Officials **Official 1:** **Affiliation:** Koç University **Name:** Kamil Darçın, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** no access criteria **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** Starting from 6 months after publication for 5 years ## 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: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown ### 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: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M5315 - Name: Bupivacaine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426693 **Brief Title:** Craving Network Neurofeedback **Official Title:** Connectome-based Neurofeedback of the Craving Network to Reduce Food Cue Reactivity #### Organization Study ID Info **ID:** 2000037084 #### Organization **Class:** OTHER **Full Name:** Yale University #### Secondary ID Infos **ID:** 1R01DK136623-01A1 **Link:** https://reporter.nih.gov/quickSearch/1R01DK136623-01A1 **Type:** NIH ### Status Module #### Completion Date **Date:** 2027-03-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-03-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) #### Lead Sponsor **Class:** OTHER **Name:** Yale University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This project tests whether individuals with overweight or obesity and high craving can learn to change their brain response to food cues using neurofeedback, to impact their craving and eating behavior. **Detailed Description:** Aim 1 of this study is to test whether neurofeedback from the craving network is associated with reduced craving network strength. Aim 2 of this study is to test whether neurofeedback from the craving network is associated with reduced food craving and changes in eating behavior. Aim 3 of this study is to test whether neurofeedback from the craving network is associated with changes in resting state functional connectivity. ### Conditions Module **Conditions:** - Overweight or Obesity ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Three imaging (fMRI) sessions of experimental feedback. **Intervention Names:** - Device: Experimental feedback **Label:** Neurofeedback **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Three imaging (fMRI) sessions of sham feedback. **Intervention Names:** - Device: Control feedback **Label:** Control neurofeedback **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Neurofeedback **Description:** Participants provided with feedback of target brain activation patterns (e.g., thermometer) and will be instructed to try to change the feedback (e.g., decrease the thermometer). **Name:** Experimental feedback **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Control neurofeedback **Description:** Participants provided with control (sham, yoked to another participant) feedback (e.g., thermometer) and will be instructed to try to change the feedback (e.g., decrease the thermometer). **Name:** Control feedback **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Craving network strength will be measured during transfer (i.e., no feedback) runs and compared across scan sessions. **Measure:** Change in craving network strength during transfer runs **Time Frame:** Week 1 and 3 **Description:** Food Craving Inventory has 28 items rated 1-5 and overall mean is calculated, range 1-5 with higher score indicating higher craving. FCI will be compared between baseline and 1 month follow-up. **Measure:** Change in Food Craving Inventory Mean Score **Time Frame:** Week 1, Week 7 **Description:** ASA-24 HEI is scored 0-100 with 100 indicating healthier diet and composite scores examined to interpret the overall score. HEI will be compared between baseline and 1 month follow-up. **Measure:** Change in Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool Healthy Eating Index (HEI). **Time Frame:** Week 1, Week 7 **Description:** Craving network strength will be measured during resting state runs and compared across scan sessions. **Measure:** Change in craving network strength during resting state runs **Time Frame:** Week 1 and 3 **Description:** Food Rating Task outcomes include healthiness, tastiness, and choice. Healthiness and tastiness mean score is taken, range 1-5, with 5 indicating higher healthiness or tastiness. Choice is counted from 0-48 items choosing the food item over the neutral reference food item, with higher values indicating more frequent choice. Food Ratings will be compared between baseline and 1 month follow-up. **Measure:** Change in Food Rating Task healthiness, tastiness, and choice scores **Time Frame:** Week 1, Week 7 **Description:** Food Snack Task will be used to measure caloric intake (out of a maximum value to calories offered) and compared across scan sessions. **Measure:** Change in Food Snack Task caloric intake **Time Frame:** Week 1 and 3 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Ages 18 to 60 years * Body mass index \>25 kg/m2 * \>2.37 Food Craving Inventory score Exclusion Criteria: * Use of anti-obesity medications * Weight-reduced state defined as \>10% weight reduction in the past 6 months. * Nicotine use * Current diagnosis of neurological or psychiatric disorder * Obesity-related diseases such as type-2 diabetes * Contraindications to MRI * Baseline scanning with motion \>0.15mm frame to frame displacement. **Healthy Volunteers:** True **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Kathleen A Garrison, PhD **Phone:** 2037376232 **Role:** CONTACT ## 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: M12701 - Name: Obesity - 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: D000050177 - Term: Overweight ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426680 **Brief Title:** A Study of the ILB-3101 in Patients With Advanced Solid Tumors **Official Title:** Phase I/II Study of the ILB-3101 in Patients With Advanced Solid Tumors #### Organization Study ID Info **ID:** CILB3101A101 #### Organization **Class:** INDUSTRY **Full Name:** Innolake Biopharm ### Status Module #### Completion Date **Date:** 2026-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-08 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Innolake Biopharm #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** ILB-3101 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of ILB-3101 in Chinese advanced solid tumor patients. **Detailed Description:** This is an open-label, multi-center, dose-escalation and expansion, first-in-human phase 1 study in Chinese adult participants with locally advanced or metastatic solid tumors. This study will consist of two parts: A Part Ia dose escalation stage and a Part Ib dose expansion stage. The objectives of this study are to evaluate the safety, tolerability, PK and preliminary anti-tumor activity, describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) of HS-20093. Part I: Participants with advanced cancer are eligible for dose escalation study if they have progressed on or intolerant to available standard therapies, or no standard or available curative therapy exists. The dose escalation will include an initial accelerated titration design followed by 3+3 design. Part II: Enrollment into dose expansion will begin after identification of the MTD or MAD in Phase I. The dose expansion study will be conducted in populations with the following indications: ovarian cancer, small cell lung cancer, head and neck squamous cell carcinoma, soft tissue sarcoma (including uterine sarcoma), triple negative breast cancer, esophageal squamous cell carcinoma, prostate cancer, etc.. All patients will be carefully followed for adverse events during the study treatment and for 28 days after the last dose of study drug. Subjects will be permitted to continue therapy with assessments for progression if the product is well tolerated and sustained clinical benefit exists. ### Conditions Module **Conditions:** - Advanced Solid Tumor ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 240 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** There are eight escalating dose cohorts. Intravenous (IV) administration of ILB-3101 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression. **Intervention Names:** - Biological: ILB-3101 **Label:** ILB-3101 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - ILB-3101 **Description:** There are eight escalating dose cohorts. **Name:** ILB-3101 **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Dose-limiting toxicity for ILB-3101 **Measure:** DLT **Time Frame:** Up to day 21 from the first dose **Description:** Maximum tolerated dose (MTD) for ILB-3101 **Measure:** MTD **Time Frame:** Up to day 21 from the first dose #### Secondary Outcomes **Description:** Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1. **Measure:** ORR **Time Frame:** From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months **Description:** AE assessed by investigator exclusively related to subject's underlying disease or medical condition \[graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0\]. Any untoward medical occurrence in a clinical study participant, whether or not considered related to the medicinal product. Incidence and severity of AEs are assessed according to vital signs, laboratory variables, physical examination, electrocardiogram, etc. **Measure:** Incidence and severity of adverse events (AEs) **Time Frame:** From the first dose through 90 days post end of treatment **Description:** Serum samples were collected for the determination of anti-drug antibody (ADA) at designated time points. **Measure:** Percentage of participants with antibodies to ILB-3101 in serum **Time Frame:** From pre-dose to 90 days post end of treatmen **Description:** Cmax will be obtained following administration of the first dose of ILB-3101 during the first cycle. **Measure:** Observed maximum plasma concentration (Cmax) of ILB-3101 in participants with advanced solid tumor **Time Frame:** From pre-dose to 21 days after the first dose on Cycle 1 **Description:** Tmax will be obtained following administration of the first dose of ILB-3101 during the first cycle. **Measure:** Time to reach maximum plasma concentration (Tmax) of ILB-3101 following the first dose in participants with advanced solid tumor **Time Frame:** From pre-dose to 21 days after the first dose on Cycle 1 **Description:** Apparent terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz. **Measure:** Terminal half-life (T1/2) of ILB-3101 following IV dose in participants with advanced solid tumor **Time Frame:** From pre-dose to 21 days after the first dose on Cycle 1 **Description:** Area under the plasma concentration versus time curve from time zero to the last sampling time when the concentration was no less than the lower limit of quantification (LLQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule. **Measure:** Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of ILB-3101 **Time Frame:** From pre-dose to 21 days after the first dose on Cycle 1 **Description:** DoR was defined as the period from the first occurrence of CR or PR to PD or death from any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) would be used \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\]. **Measure:** Duration of response (DOR) determined by investigators according to RECIST 1.1 **Time Frame:** From the first dose up to PD or death, whichever came first, assessed up to 24 months **Description:** Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). DCR was evaluated by the number of participants with best overall response of CR, PR and stable disease (SD) \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks); SD shall be assessed at least 5 weeks after the first dose\]. **Measure:** Disease control rate (DCR) determined by investigators according to RECIST 1.1 **Time Frame:** From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months **Description:** Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). PFS was defined as the time from random assignment (dose expansion stage) or first dose (dose escalation stage) to PD or death from any cause. **Measure:** Progression-free survival (PFS) determined by investigators according to RECIST 1.1 **Time Frame:** From the randomization/first dose up to PD or death, whichever came first, assessed up to 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Have signed informed consent forms voluntarily. 2. 18-80 years old. 3. Having an ECOG performance status score of 0 or 1. 4. With an expected survival of more than 12 weeks. 5. Diagnosed histologically or cytologically with local advanced or metastatic solid cancer, and under one of following situations: standard treatment-refractory (disease progression or no response), treatment-resistant, unable to receive treatment, or the standard treatment is unavailable. 6. Need to provide archived tumor tissue samples (Formalin fixed or paraffin embedded tissue blocks or at least 5 unstained sections); During the dose escalation stage, for subjects who are unable to provide tumor samples or have insufficient samples, the decision to enroll may be made based on specific circumstances after discussion with the sponsor. 7. At least one assessable tumor lesion is present during the dose escalation phase, and according to RECIST version 1.1, at least one measurable tumor lesion is present during the dose escalation phase (CRPC can be determined based on PCWG3). 8. Having sufficient bone marrow, liver, and kidney functions (based on the normal value of the clinical trial site): 1. Absolute neutrophil count (ANC) ≥ 1.5×109/L. 2. Platelets ≥ 75×109/L. 3. Hemoglobin ≥ 90g/L. 4. Total serum bilirubin ≤ 1.5×upper limit of normal (ULN). 5. Without liver metastases, ALT, AST ≤ 2.5×ULN; with liver metastases, ALT, AST ≤ 5×ULN. 6. Serum creatinine ≤1.5 × ULN. 7. Creatinine clearance rate (CrCl) (creatinine only ˃ Calculation required for 1.5 × ULN ≥50 mL/min (Calculate according to Cockcroft Fault formula), 8. International Normalized Ratio (INR) ≤ 1.5×ULN, APTT ≤ 1.5×ULN. 9. Echocardiographic LVEF (left ventricular ejection fraction) ≥ 50%. 10. QT interval corrected by Fridericia method (QTcF) Male\<450ms; Female\<470ms. 9. The serum pregnancy test results of female subjects of childbearing age are negative. 10. Male or female patients of childbearing potential must agree to use effective methods of contraception (such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives and intrauterine devices) during the study period and within 90 days after the last dosing. Exclusion Criteria: 1. Within 3 weeks prior to the first administration, systemic anti-tumor therapy has been received, including chemotherapy, curative radiotherapy (palliative radiotherapy for a single lesion within 3 weeks prior to enrollment is allowed, and radiotherapy is not allowed for measurable lesions before enrollment unless it is confirmed that the lesion has progressed after radiotherapy), biological therapy, immunotherapy, etc., except for the following: 1. Received urea nitrite or mitomycin C within 6 weeks prior to the first use of the study drug. 2. Oral administration of fluorouracil or small molecule targeted drugs within 2 weeks prior to the first use of the investigational drug or within 5 half-lives of the drug (whichever is longer). 3. Individuals who have received endocrine therapy within 2 weeks prior to the first use of the investigational drug. 4. Traditional Chinese patent medicines and simple preparations or traditional Chinese medicine with anti-tumor indication within 1 week before the first use of the study drug. 2. Patients who received other clinical trial drug within 4 weeks before the first dosing. 3. Within 3 years prior to the first trial drug treatment, the patient had other active malignant tumors, except for the tumors participating in this study and other locally cured tumors (such as basal skin cancer, papillary thyroid cancer, or any type of in situ cancer that has been completely removed, such as cervical in situ cancer, ductal carcinoma in situ, etc.). 4. The presence of clinically uncontrollable pleural/abdominal effusion, pericardial effusion, determined by the investigators as unsuitable for inclusion. 5. Suffering from central nervous system metastasis and/or cancerous meningitis. Except for asymptomatic or asymptomatic central nervous system metastases that have been clinically controlled but are judged stable by investigators, the following conditions must also be met: 1. Stable clinical symptoms for at least 4 weeks before receiving trial drug treatment. 2. No evidence of central nervous system disease progression was found in imaging examinations within 4 weeks prior to the first trial drug treatment. 3. Antiepileptic drugs have been discontinued at least 2 weeks prior to the first trial drug treatment, and the dosage of prednisone is ≤ 10mg/day or equivalent dose of steroids. 4. For patients with intracranial lesions, if they have received treatment (such as radiotherapy) before the first trial drug treatment, elution should be ≥ 2 weeks. Cancer induced encephalitis should be excluded regardless of its stable clinical condition. 6. Receiving drug therapy known to prolong the QT interval or potentially lead to torsade de pointe ventricular tachycardia; Or continue to receive these medications during the research period. 7. Acute coronary syndrome occurring within the past 6 months, including myocardial infarction, unstable angina, symptomatic congestive heart failure (New York Heart Association classification II-IV), aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events; Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III-degree atrioventricular block, etc. 8. Suffering from clinically uncontrollable diseases, including but not limited to severe diabetes (diabetes ketoacidosis or hyperglycemia hyperosmolality occurred within 6 months before the first administration, and the detection value of glycosylated hemoglobin in the screening period was ≥ 7.5%); Refractory hypertension (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 100mmHg after optimal medical treatment within the first month of screening) or a history of hypertensive crisis or hypertensive encephalopathy. 9. Individuals with previous or current interstitial lung disease (excluding radiation pneumonia that does not require hormone therapy). 10. Evidence of persistent uncontrolled systemic bacterial, fungal, or viral infections (including HIV infection, HIV antibody positive; syphilis infected individuals) and current need for intravenous anti infection treatment. 11. Provisions on hepatitis B and hepatitis C: if hepatitis B surface antigen (HBsAg) is positive, and HBV-DNA\>2000 IU/ml or 104 copies/ml, hepatitis B virus infected persons should receive antiviral treatment according to local guidelines and standards and are willing to receive antiviral treatment throughout the study period; Hepatitis C antibody positive, and HCV RNA higher than the upper limit of normal values in the study site; 12. Within 14 days prior to the first administration, systemic corticosteroids (prednisone\>10mg/day or equivalent doses of similar drugs) or other immunosuppressive treatments have been received, except for the following: 1. Use local, ocular, intra-articular, intranasal, and inhaled corticosteroids for treatment. 2. short term use of glucocorticoids for preventive treatment (such as preventing contrast agent allergies). 13. Within 4 weeks before the first administration or planned to receive attenuated live vaccines during the study period. 14. Having undergone major organ surgery (excluding biopsy) or significant trauma within 4 weeks prior to the first administration or requiring elective surgery during the trial period. 15. Individuals who have received allogeneic hematopoietic stem cell transplantation or organ transplantation in the past. 16. Known to have alcohol or drug dependence. 17. Individuals with mental disorders or poor compliance. 18. The adverse reactions of previous anti-tumor treatments have not yet recovered to CTCAE5.0 ≤ Grade 1 (excluding toxicity judged by the investigators to have no safety risk, such as hair loss, grade 2 peripheral neurotoxicity, stable hypothyroidism after hormone replacement therapy, etc.); 19. Known to cause clinically significant allergic reactions to the active ingredients and excipients, antibodies, and other monoclonal antibodies. 20. Pregnant (positive pregnancy test prior to dosing) or breast-feeding women. 21. The investigators believe that the subjects are not suitable to participate in this clinical study due to other reasons. **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:** Yan Li, MD **Phone:** 18610580233 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Xue Wang **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Fudan University **Name:** Jian Zhang, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Fudan University **Name:** Hongxia Wang **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426667 **Brief Title:** Effect of Radiofrequency Treatment in Plantar Fasciitis Patients **Official Title:** Effect of Radiofrequency Treatments on Foot Functionality Index, Patient Satisfaction and Pain Scores in Plantar Fasciitis Patients #### Organization Study ID Info **ID:** 2024/202 #### Organization **Class:** OTHER **Full Name:** Ankara University ### Status Module #### Completion Date **Date:** 2024-07-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-18 **Study First Submit QC Date:** 2024-05-18 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ankara University #### Responsible Party **Investigator Affiliation:** Ankara University **Investigator Full Name:** Hanzade Aybuke Unal **Investigator Title:** Medical Doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** In adults, chronic plantar fasciitis stands as the predominant cause of persistent heel discomfort.Usually, individuals depict a pulsating pain concentrated around the point of origin of the plantar fascia on the calcaneus. Numerous randomized and non-randomized studies have demonstrated the effectiveness of radiofrequency as a treatment modality for chronic plantar heel pain.In this study, our objective is to assess the impact of radiofrequency modalities applied to the posterior tibial nerve and/or the calcaneal spur area, guided by ultrasound, on patient satisfaction, pain scores, and functional improvement in individuals with chronic plantar fasciitis **Detailed Description:** Chronic plantar fasciitis is the most common cause of chronic heel pain in adults. Typically, patients describe a throbbing pain localized around the origin of the plantar fascia on the calcaneus. This pain is often most severe when taking the first steps in the morning or rising after sitting. It typically improves with activity but worsens with prolonged activity. The primary aim of heel spur treatment is to alleviate pain and restore function. Surgical interventions are recommended for chronic plantar heel pain resistant to conservative options. However, surgery may be associated with prolonged recovery, and in one study, superiority over conservative treatment was not demonstrated. Radiofrequency has been shown to be an effective treatment method for chronic plantar heel pain in many randomized and non-randomized studies. In many studies, most of these procedures are applied blindly based on anatomical landmarks, with attention drawn in many studies to applications targeting the terminal branches of the posterior tibial nerve or the spur region. Only a few studies have been performed using fluoroscopy and ultrasound guidance. Ultrasound guidance offers several advantages over fluoroscopy and blind landmark techniques, especially in interventional procedures targeting neural and soft tissues. These advantages include the ability to visualize vascular and neural structures, very low risk of vascular-neural injury, absence of radiation exposure, and superiority in cases of anatomical variation. However, a common point in many studies related to plantar fasciitis is that applications are either directed to the spur area or to neural structures leading to the heel region. In this study, we aim to compare the effects of radiofrequency modalities applied to the posterior tibial nerve and/or calcaneal spur area under ultrasound guidance on patient satisfaction, pain scores, and patient functionality in cases of chronic plantar fasciitis (heel spur). ### Conditions Module **Conditions:** - Fasciitis, Plantar **Keywords:** - Fasciitis, Plantar - Radiofrequency Therapy ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 108 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** posterior tibial nerve pulsed radiofrequency treatment **Intervention Names:** - Procedure: posterior tibial nerve radiofrequency **Label:** posterior tibial nerve radiofrequency #### Arm Group 2 **Description:** calcaneal spur thermocoagulation radiofrequency treatment **Intervention Names:** - Procedure: plantar fasciitis radiofrequency **Label:** plantar fasciitis radiofrequency #### Arm Group 3 **Description:** posterior tibial nerve pulsed radiofrequency and calcaneal spur thermocoagulation radiofrequency treatment **Intervention Names:** - Procedure: posterior tibial nerve radiofrequency - Procedure: plantar fasciitis radiofrequency **Label:** posterior tibial nerve and plantar fasciitis radiofrequency ### Interventions #### Intervention 1 **Arm Group Labels:** - posterior tibial nerve and plantar fasciitis radiofrequency - posterior tibial nerve radiofrequency **Description:** pulse radiofrequency at 45 V for 300 seconds at 42 degrees Celsius is applied to the posterior tibial nerve area. During the procedure, the temperature at the electrode tip is kept below 42°C. Following negative aspiration (in the absence of blood), 2 cc of 1% lidocaine + 4 mg dexamethasone is applied to the same area. **Name:** posterior tibial nerve radiofrequency **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - plantar fasciitis radiofrequency - posterior tibial nerve and plantar fasciitis radiofrequency **Description:** the spur area on the calcaneal bone is identified, and sensory and motor stimulations are applied using the RF cannula. If no sensory or motor response is elicited in the area, conventional radiofrequency at 45 V for 60 seconds at 80 degrees Celsius is applied to the spur area after confirming the placement of the RF cannula. **Name:** plantar fasciitis radiofrequency **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** pain severity change by using Numeric Rating Scala will be observed before and at 1, 3 months after the procedure. pain severity change by using Numeric Ratin Scala was observed 3 months after the procedure.The 11-point numerical scale ranges from '0', representing "no pain", to '10', representing extreme pain (e.g., "pain as bad as you can imagine" or "worst pain imaginable"). **Measure:** pain severity **Time Frame:** 1 and 3 months **Description:** Patients will evaluate their satisfaction after the procedure as "satisfied", "uncertain" or "not satisfied". **Measure:** Patient satisfaction after the procedure **Time Frame:** 1 and 3 months **Description:** Functionality of foot will be observed at before the procedure and 1, 3 months after the procedure. Foot functionalliy index will be used. Foot function index consists of 23 items with 3 subgroups: pain, disability and activity limitation. To calculate the subscales and total score, the scores of each item are summed, divided by the sum of the maximum scores of the items and multiplied by 100. Higher scores indicate more pain, disability, and activity limitation. The survey score varies between 0-100, and as the score increases, the disability increases. **Measure:** functionallity **Time Frame:** 1 and 3 months **Description:** number of medication use (nonsteroidal anttinflamatort drugs, opioids, muscle relaxants) wiil be evaluated **Measure:** medication use **Time Frame:** 1 and 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18-65 years old, * Heel pain for at least 6 months and a diagnosis of plantar fasciitis confirmed by direct radiography and physical examination, * Visual analog scale is 4 or more * No response to conservative treatment (medical and physical medicine modalities) Exclusion Criteria: * History of trauma or calcaneus fracture, * Osteoarthritis, Diabetes mellitus, chronic heart disease * Presence of pregnancy, * Pain due to peripheral neuropathy or ischemia * Inability to tolerate injections in the heel area, * Allergy to local anesthetics or steroids, * Presence of an open wound on the side of the foot that the injection will be performed * Local or systemic infection at the time of the procedure * Previous steroid injection, radiofrequency application or ESWT (electroshock wave) treatment into the heel * History of surgical intervention to the heel * Presence of any functional limitation in the affected foot * Presence of neurological, hepatic and/or metabolic diseases; dermatological infections, seronegative spondyloarthropathy, bleeding diathesis * Failure to discontinue anticoagulant or antiaggregant within the specified periods * Absence of follow-up throughout the study. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients between the ages of 18 and 65 who are scheduled to receive radiofrequency tretament due to plantar fasciitis will be included in the study. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Hanzade A Unal, MD **Phone:** +905057179039 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Gungor E Özgencil, Prof **Phone:** +903125852404 **Role:** CONTACT #### Locations **Location 1:** **City:** Ankara **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Hanzade A Ünal, MD - **Phone:** +905057179039 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Güngör E Özgencil, Prof - **Phone:** +903125082404 - **Role:** CONTACT **Country:** Turkey **Facility:** Ankara University **Status:** RECRUITING **Zip:** 06230 #### Overall Officials **Official 1:** **Affiliation:** Ankara University **Name:** Hanzade A Unal, MD **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Latt LD, Jaffe DE, Tang Y, Taljanovic MS. Evaluation and Treatment of Chronic Plantar Fasciitis. Foot Ankle Orthop. 2020 Feb 13;5(1):2473011419896763. doi: 10.1177/2473011419896763. eCollection 2020 Jan. **PMID:** 35097359 **Citation:** Li X, Zhang L, Gu S, Sun J, Qin Z, Yue J, Zhong Y, Ding N, Gao R. Comparative effectiveness of extracorporeal shock wave, ultrasound, low-level laser therapy, noninvasive interactive neurostimulation, and pulsed radiofrequency treatment for treating plantar fasciitis: A systematic review and network meta-analysis. Medicine (Baltimore). 2018 Oct;97(43):e12819. doi: 10.1097/MD.0000000000012819. **PMID:** 30412072 **Citation:** Wu YT, Chang CY, Chou YC, Yeh CC, Li TY, Chu HY, Chen LC. Ultrasound-Guided Pulsed Radiofrequency Stimulation of Posterior Tibial Nerve: A Potential Novel Intervention for Recalcitrant Plantar Fasciitis. Arch Phys Med Rehabil. 2017 May;98(5):964-970. doi: 10.1016/j.apmr.2017.01.016. Epub 2017 Feb 14. **PMID:** 28209507 **Citation:** Orhurhu V, Urits I, Orman S, Viswanath O, Abd-Elsayed A. A Systematic Review of Radiofrequency Treatment of the Ankle for the Management of Chronic Foot and Ankle Pain. Curr Pain Headache Rep. 2019 Jan 19;23(1):4. doi: 10.1007/s11916-019-0745-5. **PMID:** 30661127 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000005534 - Term: Foot Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - 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: M8351 - Name: Fasciitis - Relevance: HIGH - As Found: Fasciitis - ID: M24656 - Name: Fasciitis, Plantar - Relevance: HIGH - As Found: Fasciitis, Plantar - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M8658 - Name: Foot Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005208 - Term: Fasciitis - ID: D000036981 - Term: Fasciitis, Plantar ### Intervention Browse Module - Browse Branches - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: ChanBlk - Name: Channel Blockers - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: AnEm - Name: Antiemetics - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M11014 - Name: Lidocaine - Relevance: LOW - As Found: Unknown - ID: M7102 - Name: Dexamethasone - Relevance: LOW - As Found: Unknown - ID: M235549 - Name: Dexamethasone acetate - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426654 **Brief Title:** Sintilimab Combined With LDRT for Neoadjuvant Treatment of Locally Advanced dMMR/MSI-H Gastric Cancer **Official Title:** Sintilimab Combined With Low-dose Radiation Therapy for Neoadjuvant Treatment of Locally Advanced Deficient Mismatch Repair/Microsatellite Instability-high Gastric Cancer: a Prospective, Multi-center, Single-arm, Phase Ib/II Clinical Trial #### Organization Study ID Info **ID:** WCH242145 #### Organization **Class:** OTHER **Full Name:** West China Hospital ### Status Module #### Completion Date **Date:** 2027-08-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-10 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** West China Hospital #### Responsible Party **Investigator Affiliation:** West China Hospital **Investigator Full Name:** Ming Liu **Investigator Title:** Clinical Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Recently, growing evidences have suggested that immunotherapy represents a promising treatment option for the neoadjuvant treatment of locally advanced mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) gastric cancer. In this study, we will explore the efficacy and safety of sintilimab and LDRT in the neoadjuvant treatment for locally advanced dMMR/MSI-H G/GEJ cancer. **Detailed Description:** This is a prospective, multicenter, single-arm, phase Ib/II trial. In the phase Ib, 4 cases will be enrolled in each treatment group. In the phase II study, a total of 33 patients will be enrolled. Eligible patients will be registered and receive four cycles of sintilimab. Simultaneously, LDRT will be planned and administered. Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of sintilimab. The primary endpoint of phase Ib is to determine the optimal radiation dose for phase II study. The primary endpoint of phase II is the pathological complete response (pCR) rate. Secondary endpoints include R0 resection rate, major pathological response (MPR), objective response rate (ORR), 3-year event-free survival (EFS) rate, 3-year overall survival (OS) rate and safety profile of the neoadjuvant regimen. ### Conditions Module **Conditions:** - Gastric Cancer **Keywords:** - gastric cancer - neoadjuvant therapy - sintilimab - LDRT ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 45 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Laparoscopic exploration is required in all patients to detect occult peritoneal metastases. All patients will start with one cycle of neoadjuvant therapy of sintilimab: 200 mg, iv drip, d1, q3w. Then, LDRT will be performed in the target area (including the primary gastric lesion and positive/suspected positive lymph nodes). After radiotherapy, patients will receive another three cycles of sintilimab. Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of sintilimab. The adjuvant therapy will start in 4-6 weeks after the surgery, and we recommend adjuvant treatment with sintilimab for up to 10 cycles. **Intervention Names:** - Drug: sintiliman plus LDRT **Label:** sintilimab+LDRT **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - sintilimab+LDRT **Description:** All patients will start with one cycle of neoadjuvant therapy of sintilimab: sintilimab 200 mg, iv drip, d1, q3w. LDRT will be performed in the target area. After radiotherapy, patients will receive another three cycles of sintilimab. Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of sintilimab. The adjuvant therapy will start in 4-6 weeks after the surgery, and we recommend adjuvant treatment with sintilimab for up to 10 cycles. **Name:** sintiliman plus LDRT **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** defined as the absence of viable tumor cells assessed by histological evaluation criteria after neoadjuvant therapy **Measure:** pCR rate **Time Frame:** 5 months after the last subject participating in #### Secondary Outcomes **Description:** defined as the rate of the complete surgical removal of any residual cancer cells in the tumor bed **Measure:** R0 resection rate **Time Frame:** 5 months after the last subject participating in **Description:** defined as tumor residual cells ≤10% in the surgical specimen **Measure:** MPR rate **Time Frame:** 5 months after the last subject participating in **Description:** defined as the proportion of patients without event 23 years after enrolment **Measure:** 3-year event-free survival (DFS) **Time Frame:** every 3 month postoperation up to 36 months **Description:** defined as the proportion of patients survived 3 years after enrolment **Measure:** 2-year OS rate **Time Frame:** every 3 month postoperation up to 36 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age 18-80 years. 2. Histologically or cytologically confirmed diagnosis of locally advanced G/GEJ adenocarcinoma (cT2N+M0 or cT3-4aNanyM0) as assessed by exploratory laparoscopic surgery, ultrasonography and/or CT/MRI. 3. Resectable G/GEJ cancer, as judged by experienced surgeons. 4. dMMR and/or MSI-H. 4. Eastern Cooperative Oncology Group performance score (ECOG PS) ≤1. 5. Agree to provide blood, feces, and tissue specimens. 6. The expected survival is longer than 6 months. 7. There was no previous antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, and other treatments with antitumor effects). 8. Adequate organ and hematological function. 9. Strict contraception. 10. Patients must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure. Exclusion Criteria: 1. Unable to comply with the research program or procedures. 2. Undergoing other drug clinical trials or having participated in any drug clinical trials one month before enrollment. 3. Active autoimmune disease or history of refractory autoimmune disease. 4. Receiving corticosteroids (\> 10mg/d prednisone or equivalent dose of steroids) or other systematic immunosuppression therapies within 14 days before enrollment, excluding the following therapies: steroid hormone replacement therapy (≤10mg/d); local steroid therapy; and short-term, prophylactic steroid therapy for preventing allergies or nausea and vomiting. 5. Active or clinically significant cardiac disease: 1. Congestive heart failure \> New York Heart Association (NYHA) class 2; 2. Active coronary artery disease; 3. Arrhythmias requiring treatment other than β-blockers or digoxin; 4. Unstable angina (with angina symptoms at rest), new angina within 3 months before enrollment, or new myocardial infarction within 6 months before enrollment 6. Other tumors that have not been treated or exist at the same time, except carcinoma in situ of the cervix, treated basal cell carcinoma or superficial bladder tumor. If the tumor was cured and no evidence of disease was found for more than 3 years, the patient can be enrolled. All other tumors must be treated at least 3 years before enrollment. 7. Patients with a history of HIV infection or active hepatitis B/C. 8. Ongoing \> level 2 infection. 9. Symptomatic brain metastasis or meningioma. 10. Unhealed wounds, ulcers or fractures. 11. Renal failure patients requiring blood or peritoneal dialysis. 12. Epileptic that needs medication. 13. Active, symptomatic interstitial pneumonia, pleural or ascites that causes dyspnea (dyspnea ≥ 2 grade). 14. History of organ transplantation (including corneal transplantation). 15. Allergic to research drugs or similar drugs, or suspected allergies. 16. Pregnant or lactating women. 17. The investigator believes that patients who are not suitable for the study. 18. Medical, psychological or social conditions can affect the recruitment of patients and evaluation of study results. 19. Other antitumor therapy (chemotherapy, radiotherapy, surgery, immunotherapy, biotherapy, chemoembolization) other than investigator drugs. Palliative external irradiation for non-target lesions is allowed. 20. Previously used similar immune checkpoint inhibitors. 21. Major surgery 4 weeks before recruitment, open biopsy or major trauma surgery (excluding biliary stents, or percutaneous biliary drainage). 22. Treatment with antitumor Chinese herbal medicine. **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:** Pengfei Zhang, M.D **Phone:** +86-17828163584 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Ming Liu, M.D. **Phone:** +86-18980606324 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** West China Hospital **Name:** Kun Yang, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## 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: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16064 - Name: Stomach Neoplasms - Relevance: HIGH - As Found: Gastric Cancer - ID: M27510 - Name: Microsatellite Instability - 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: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System 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 ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426641 **Brief Title:** Polyethylene Wear Particle Analysis of TKA **Official Title:** Polyethylene Wear Particle Analysis of Total Knee Arthroplasty -International Multicenter Study- #### Organization Study ID Info **ID:** OMU 2023-108 #### Organization **Class:** OTHER **Full Name:** Osaka Metropolitan University ### Status Module #### Completion Date **Date:** 2028-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-12-05 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Mayo Clinic **Class:** OTHER **Name:** Istituto Ortopedico Rizzoli **Class:** OTHER **Name:** Hospital for Special Surgery, New York #### Lead Sponsor **Class:** OTHER **Name:** Osaka Metropolitan University #### Responsible Party **Investigator Affiliation:** Osaka Metropolitan University **Investigator Full Name:** Yukihide Minoda **Investigator Title:** Associate professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study was to investigate whether polyethylene (Vitamin E-containing polyethylene), which has been newly introduced and widely used clinically as a biomaterial for tibial inserts in total knee arthroplasty, but whose mid- to long-term clinical results are still unknown, is more effective than conventional polyethylene. Our goal is to clarify through an international multi-center joint study using in vivo polyethylene wear particle analysis, which the investigators developed as a method to provide early feedback, as to whether polyethylene wear debris production in vivo can be reduced. **Detailed Description:** Anticipated medical contribution and significance In this study, the investigators investigate whether a newly introduced polyethylene (highly cross-linked polyethylene, vitamin E-containing polyethylene in vivo) can suppress wear debris production more than conventional polyethylene. If the newly introduced polyethylene can reduce wear debris production, it is expected to reduce failure of artificial joints in the future. However, if newly introduced polyethylene is actually increasing wear debris production, it could be an early alarm bell for surgeons around the world. In other words, the international and social impact of this research is extremely large. Two unique requirements are necessary to carry out this research. Firstly, in vivo analysis of polyethylene wear particles is possible, and secondly, the number of surgical cases of revision knee arthroplasty targeted for investigation is large. The first requirement is that the applicants have published many English-language papers on in vivo polyethylene wear debris analysis, and that their facilities are the most suitable and fully capable of carrying out the analysis worldwide. be. The second requirement is that the investigators need to collaborate not only with our hospital but also with facilities that perform a large number of revision knee arthroplasty surgeries. Not only our hospital, but also our affiliated hospital, which is one of the facilities in Japan that performs the most knee joint surgeries (Naniwa Ikuno Hospital), and the hospital that performs the most knee joint surgeries worldwide (Mayo Clinic \[USA\]). , Hospital for Special Surgery \[USA\], Istituto Ortopedico Rizzoli \[Italy\]). Research method In this study, the investigators conducted the following steps to determine the in vivo wear particles (number, size, and morphology) of conventional polyethylene, whose long-term results have already been clarified, and vitamin E-containing polyethylene, whose mid- to long-term results have not yet been clarified. Clarifying the difference \[Figure 3\]. Target of this research In this study, the investigators will focus on patients undergoing revision knee arthroplasty as a routine medical treatment. First total joint replacement * 30 patients using polyethylene containing Vitamin E * 30 patients using conventional polyethylene (no highly cross-linking) * 30 patients using conventional polyethylene (with highly cross-linking) Accumulation of periarticular tissue In this study, the investigators will focus on patients undergoing revision knee arthroplasty as a routine medical treatment. The test will be conducted after obtaining approval from the ethics committee at each facility and obtaining informed consent. The pericapsular tissue, which is removed during surgery and usually discarded, is obtained and fixed in formalin fixative. The tissue will be transported to the Department of Orthopedic Surgery, Osaka Public University Graduate School of Medicine for analysis. International transportation of tissues requires outsourcing to specialized companies with experience in transporting tissues from overseas. Isolation of polyethylene wear debris The collected tissue around the joint capsule is immersed in 5M NaOH at 65°C for 1 hour to decompose the protein. Make a sucrose layer (5, 10, 20%) in a 14ml tube (14PA tube, Hitachi Koki Co, Ltd, Tokyo, Japan), add the dissolved solution, and place in an ultracentrifuge (CP100a, P28S1014 rotor, Hitachi Koki). Ultracentrifuge at 28,000 rpm \[103,7009g\] for 3 hours at 4°C. Prepare an isopropanol layer (0.90 and 0.96 g/mL) in a 40 ml tube (40PA tube, Hitachi Koki Co, Ltd, Tokyo, Japan), add the upper layer of sucrose layer, and centrifuge at 28,000 rpm (103,7009 g ) and perform ultracentrifugation at 4°C for 1 hour. The isopropanol interlayer is collected to isolate polyethylene wear debris. Analysis of polyethylene wear debris The isopropanol interlayer is filtered through a 0.1 μm polycarbonate filter (VCTP 013-00, Millipore Corporation, Bedford, MA). Dry the polycarbonate filter, fix it on an aluminum pedestal (M4, Nisshin EM Co, Ltd, Tokyo, Japan), and apply platinum coating (E-1030 ion sputter, Hitachi Science Systems Ltd, Tokyo, Japan). Observe the polyethylene wear particles on the polycarbonate filter using a scanning electron microscope (S4700SI, Hitachi Ltd, Tokyo, Japan), and analyze the following items using an image analyzer (Mac Scope, Mitani Co, Tokyo, Japan). * Number of polyethylene wear particles (number per 1g of tissue) * Size (Equivalent circle diameter \[μm\]) * Shape (aspect ratio, roundness) Comparison of iv vivo polyethylene wear powder morphology depending on polyethylene material The number, size, and form of polyethylene wear debris will be compared between conventional polyethylene, whose long-term results have already been clarified, and vitamin E-containing polyethylene, whose medium- to long-term results have not yet been clarified. The investigators also investigated factors that affect polyethylene wear in vivo (age, height, weight, period from initial surgery to revision surgery, knee joint range of motion, knee prosthesis clinical score \[Knee Society Score, University of California at Los Angeles activity score\]). Evaluation items (outcome) Main evaluation items: Polyethylene wear particle morphology (number of wear particles, equivalent circle diameter \[㎛\], aspect ratio, roundness) \[Reason for setting primary endpoints\] Because it is a standard evaluation item for evaluating polyethylene wear debris. Secondary endpoints: * Body mass index * Knee joint range of motion * Clinical score (2011Knee Society Score, Knee injury and Osteoarthritis Outcome Score for Joint Replacement, University of California at Los Angeles activity score) \[Reason for setting secondary endpoints\] Because it may affect the production of polyethylene wear debris. Planned number of research subjects and basis for setting it (including cases where the number of research subjects is set without relying on statistical grounds) Total 90 cases * 30 patients using polyethylene containing Vitamin E * 30 patients using conventional polyethylene (no high cross-linking) * 30 patients using conventional polyethylene (with high cross-linking) Rationale for setting: The target number of cases was determined from the number of cases at related institutions within the study period. ### Conditions Module **Conditions:** - Wear of Articular Bearing Surface of Prosthetic Joint - Total Knee Arthroplasty **Keywords:** - Polyethylene wear particle ### Design Module #### Bio Spec **Description:** pericapsular tissue, which is removed during surgery **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** polyethylene containing Vitamin E **Intervention Names:** - Device: Polyethylene **Label:** polyethylene containing Vitamin E #### Arm Group 2 **Description:** conventional polyethylene (no highly cross-linking) **Intervention Names:** - Device: Polyethylene **Label:** conventional polyethylene (no highly cross-linking) #### Arm Group 3 **Description:** conventional polyethylene (with highly cross-linking) **Intervention Names:** - Device: Polyethylene **Label:** conventional polyethylene (with highly cross-linking) ### Interventions #### Intervention 1 **Arm Group Labels:** - conventional polyethylene (no highly cross-linking) - conventional polyethylene (with highly cross-linking) - polyethylene containing Vitamin E **Description:** There is no intervention **Name:** Polyethylene **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** counts / g (tissue sample) **Measure:** Number of polyethylene wear particles **Time Frame:** Time of revision surgery **Description:** Equivalent circle diameter (㎛) **Measure:** Equivalent circle diameter of polyethylene wear particles **Time Frame:** Time of revision surgery **Description:** Aspect ratio **Measure:** Aspect ratio of polyethylene wear particles **Time Frame:** Time of revision surgery **Description:** Roundness **Measure:** Roundness of polyethylene wear particles **Time Frame:** Time of revision surgery #### Secondary Outcomes **Description:** kg/m2 **Measure:** Body mass index **Time Frame:** Time of revision surgery **Description:** degrees **Measure:** Knee joint extension angle **Time Frame:** Time of revision surgery **Description:** degrees **Measure:** Knee joint flexion angle **Time Frame:** Time of revision surgery **Description:** 0(worse)-100(best) **Measure:** 2011 Knee Society Score: An "Objective" Knee Score **Time Frame:** Time of revision surgery **Description:** 0(worse)-40(best) **Measure:** 2011 Knee Society Score: A Patient Satisfaction Score **Time Frame:** Time of revision surgery **Description:** 0(worse)-15(best) **Measure:** 2011 Knee Society Score: A Patient Expectation Score **Time Frame:** Time of revision surgery **Description:** 0(worse)-100(best) **Measure:** 2011 Knee Society Score: A Functional Activity Score **Time Frame:** Time of revision surgery **Description:** 0(worse)-100(best) **Measure:** Knee injury and Osteoarthritis Outcome Score for Joint Replacement **Time Frame:** Time of revision surgery **Description:** 1(worse)-10(best) **Measure:** University of California at Los Angeles activity score **Time Frame:** Time of revision surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients undergoing revision knee arthroplasty within the study period 2. Patients over 20 years old 3. Patients who have received a sufficient explanation, have sufficient understanding, and have given their free written consent. 4. Patients who have passed 2 years or more since their first total knee arthroplasty Exclusion Criteria: 1. Patients who are judged to be unsuitable as research subjects by the research physician **Minimum Age:** 20 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients undergoing revision surgery ### Contacts Locations Module #### Locations **Location 1:** **City:** Osaka **Country:** Japan **Facility:** Osaka Metroplitan Univerity **Zip:** 545-8585 #### Overall Officials **Official 1:** **Affiliation:** Osaka Metropolitan University **Name:** Yukihide Minoda, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Minoda Y, Kobayashi A, Iwaki H, Iwakiri K, Inori F, Sugama R, Ikebuchi M, Kadoya Y, Takaoka K. In vivo analysis of polyethylene wear particles after total knee arthroplasty: the influence of improved materials and designs. J Bone Joint Surg Am. 2009 Nov;91 Suppl 6:67-73. doi: 10.2106/JBJS.I.00447. No abstract available. **PMID:** 19884413 **Citation:** Minoda Y, Kobayashi A, Iwaki H, Miyaguchi M, Kadoya Y, Ohashi H, Yamano Y, Takaoka K. Polyethylene wear particles in synovial fluid after total knee arthroplasty. Clin Orthop Relat Res. 2003 May;(410):165-72. doi: 10.1097/01.blo.0000063122.39522.c2. **PMID:** 12771827 ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M17558 - Name: Vitamins - Relevance: LOW - As Found: Unknown - ID: M22972 - Name: Tocopherols - Relevance: LOW - As Found: Unknown - ID: M17553 - Name: Vitamin E - Relevance: LOW - As Found: Unknown - ID: M22975 - Name: Tocotrienols - Relevance: LOW - As Found: Unknown - ID: M22969 - Name: alpha-Tocopherol - Relevance: LOW - As Found: Unknown - ID: T466 - Name: Tocopherol - Relevance: LOW - As Found: Unknown - ID: T467 - Name: Tocotrienol - Relevance: LOW - As Found: Unknown - ID: T480 - Name: Vitamin E - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426628 **Acronym:** NIGHTINGALE **Brief Title:** Clinical Utility of Management of Patients With Pulmonary Nodules Using the Percepta Nasal Swab Classifier **Official Title:** Clinical Utility of Management of Patients With CT and LDCT Identified Pulmonary Nodules Using the Percepta Nasal Swab Classifier #### Organization Study ID Info **ID:** DHF009-050P #### Organization **Class:** INDUSTRY **Full Name:** Veracyte, Inc. ### Status Module #### Completion Date **Date:** 2026-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2022-07-18 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Veracyte, Inc. #### 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 goal of this observational study is to learn how a physician uses the results of the Percepta® Nasal Swab test to manage people with a newly identified pulmonary nodule. The main questions it aims to answer are: * Does the use of the Percepta Nasal swab test reduce the number of invasive procedures in people with a low-risk result and whose nodule is benign? * Does the use of the Percepta Nasal swab test decrease the time to treatment in people with a high-risk result and whose nodule is cancer? Participants will be randomly assigned to either a group where the test result is provided to the physician (test arm) or to a group where the test result is not provided (control arm). Researchers will compare management of participants in the two groups. **Detailed Description:** This is a prospective, multicenter, randomized study to evaluate the clinical utility of the Percepta® Nasal Swab classifier in managing patients with pulmonary nodules identified incidentally or by lung cancer screening. Patients will be randomized to either the test group, where the test result will be returned to the physician to incorporate into decision-making on how to manage the patient's nodule, or the control group which will represent the standard of care where the result will not be returned to the physician. The study will observe and evaluate how the addition of the Percepta Nasal Swab classifier result impacts current management of newly identified lung nodules. The study will enroll approximately 2400 participants meeting eligibility criteria at up to 100 centers in the US. Enrollment is expected to take approximately 24 months and participants will be followed for 24 to 30 months or until a diagnosis of lung cancer. ### Conditions Module **Conditions:** - Pulmonary Nodule, Solitary - Lung Cancer ### Design Module #### Bio Spec **Description:** Nasal swab **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 2400 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Percepta Nasal Swab test result will be returned to the physician investigator. **Label:** Test Arm #### Arm Group 2 **Description:** Percepta Nasal Swab test result will not be returned to the physician investigator. **Label:** Control Arm ### Outcomes Module #### Primary Outcomes **Description:** Invasive diagnostic procedures performed in the diagnostic workup of newly identified nodules that are benign. **Measure:** Number of invasive diagnostic procedures **Time Frame:** From date of randomization until the date the nodule is diagnosed as benign or demonstrates up to 24 months radiographic stability or resolution, assessed up to a total of 30 months. #### Secondary Outcomes **Description:** Time to treatment in the diagnostic workup of newly identified nodules that are primary lung cancer **Measure:** Time to treatment **Time Frame:** From date of randomization until the date of first documented treatment for lung cancer, assessed up to a total of 30 months. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Able to tolerate nasal epithelial specimen collection * Signed written Informed Consent obtained * Subject clinical history available for review by sponsor and regulatory agencies * New nodule identified on imaging \< 90 days prior to nasal sample collection * CT report available for index nodule * 29 - 85 years of age * Current or former smoker (\>100 cigarettes in a lifetime) * Pulmonary nodule ≤30 mm detected by CT Exclusion Criteria: * Active cancer (other than non-melanoma skin cancer) * Prior primary lung cancer (prior non-lung cancer acceptable) * Prior participation in this study (i.e., subjects may not be enrolled more than once) * Current active treatment with an investigational device or drug * Patient enrolled or planned to be enrolled in another clinical trial that may influence management of the patient's nodule * Concurrent or planned use of tools or tests for assigning lung nodule risk of malignancy other than clinically validated risk calculators **Maximum Age:** 85 Years **Minimum Age:** 29 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Current or former smokers (\>100 cigarettes in a lifetime) who are 29 - 85 years of age with a newly identified pulmonary nodule ≤30 mm detected by CT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Lori Lofaro, MSHS **Phone:** 6502436389 **Role:** CONTACT #### Locations **Location 1:** **City:** Stamford **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Majed Albache, MD, MPH - **Phone:** 203-276-4362 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Adrienne S Scott, MS, CCRC - **Phone:** 203-276-4362 - **Role:** CONTACT **Country:** United States **Facility:** The Stamford Health/The Stamford Hospital **State:** Connecticut **Status:** RECRUITING **Zip:** 06904 **Location 2:** **City:** Chicago **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Phillip Cooper - **Phone:** 312-503-0406 - **Role:** CONTACT **Country:** United States **Facility:** Northwestern University **State:** Illinois **Status:** NOT_YET_RECRUITING **Zip:** 60611 **Location 3:** **City:** Greensboro **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Bradley L Icard, DO - **Phone:** 336-522-8870 - **Role:** CONTACT **Country:** United States **Facility:** PulmonIx, LLC **State:** North Carolina **Status:** RECRUITING **Zip:** 27401 #### Overall Officials **Official 1:** **Affiliation:** Veracyte, Inc. **Name:** Phillip G Febbo, MD **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - 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: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M28260 - Name: Multiple Pulmonary Nodules - Relevance: HIGH - As Found: Pulmonary Nodules - ID: M6303 - Name: Solitary Pulmonary Nodule - Relevance: HIGH - As Found: Pulmonary Nodule, Solitary - 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 ### Condition Browse Module - Meshes - ID: D000055613 - Term: Multiple Pulmonary Nodules - ID: D000003074 - Term: Solitary Pulmonary Nodule ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426615 **Acronym:** CONSCIUS **Brief Title:** Connectivity and Neural Signatures of Consciousness in Unresponsive States **Official Title:** Connectivity and Neural Signatures of Consciousness In Unresponsive States (CONSCIUS) - a Study of Brain Activity in Disorders of Consciousness #### Organization Study ID Info **ID:** s67062 #### Organization **Class:** OTHER **Full Name:** Universitaire Ziekenhuizen KU Leuven ### Status Module #### Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-03-29 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Research Foundation Flanders #### Lead Sponsor **Class:** OTHER **Name:** Universitaire Ziekenhuizen KU Leuven #### 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 CONSCIUS study is a prospective, interventional study including patients with acute brain injury and impaired consciousness implanted with intracranial electrodes. The aim of the study is to investigate seizures and thalamocortical neural dynamics underlying behavioral unresponsiveness. **Detailed Description:** Individuals with severe brain injury often require extensive treatment in intensive care units (ICU) and hospitalization wards while uncertainty prevails about the recovery of consciousness and cognitive abilities. Especially in the acute phase after injury, treatment decisions have a tremendous impact on outcome, but rely on assessments of behavioral responsiveness which are known to be unreliable and subject to many confounders. Objective, quantifiable diagnostic and prognostic measures that can be deployed at the bedside during the ICU stay are lacking. Development of new metrics are hampered by our lack of a fundamental understanding of (i) thalamocortical network mechanisms underlying consciousness and (ii) brain-injury induced neural dynamics impacting both consciousness and outcome. Continuous EEG monitoring has been used to aid in this respect to (i) predict recovery of consciousness and outcome, and (ii) diagnose nonconvulsive seizures in unresponsive patients. Although promising, it lacks sensitivity, spatial resolution, and causal power. There is an urgent need for techniques allowing high-precision detection of pathological dynamics, patient stratification and prediction of a capacity for consciousness recovery in acute unresponsive patients with brain injury. Intracranial electrodes as part of multimodal monitoring in subjects with impaired consciousness and severe brain injury allow continuous bedside recordings of high spatiotemporal resolution in different network nodes and allows inducing brain perturbations, transcending correlational evidence of network analysis. This technique could increase the detection and treatment of nonconvulsive seizures contributing to brain injury and unresponsiveness and simultaneously allows to study networks supporting consciousness. This can lead to new diagnostic and prognostic biomarkers for recovery based on thalamocortical profiles of activity, reactivity (complexity) and connectivity, ultimately paving to way for the development of biomarker-driven treatments to support early recovery such as deep brain stimulation. Eventually this can contribute to clinical decision making: abstaining from aggressive treatment in patients with no potential for recovery, and more importantly, continuing treatment in subjects with a responsive brain but without clear behavioural correlate. ### Conditions Module **Conditions:** - Acute Brain Injury - Traumatic Brain Injury - Consciousness Disorders - Seizures **Keywords:** - Consciousness - Seizures - Neural dynamics - Intracranial recordings and stimulation ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Prospective inclusion of patients implanted with intracranial electrodes. ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with acute brain injury with reduced consciousness that undergo multimodal intracranial monitoring, or with suspected seizures **Intervention Names:** - Device: Intracranial electrodes **Label:** Acute brain injury **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Acute brain injury **Description:** Placement of intracranial electrodes in the cortico-subcortical system **Name:** Intracranial electrodes **Other Names:** - Depth electrodes **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The primary aim is to compare the incidence of ictal and ictal-interictal continuum epileptiform activity on intracranial versus scalp EEG. **Measure:** Incidence of electrographic epileptiform activity (ictal and ictal-interictal continuum activity) on intracranial versus scalp electroencephalography (EEG). **Time Frame:** A maximum of 4 weeks after electrode implantation. #### Secondary Outcomes **Description:** Correlation of profiles of neural activity and reactivity with the behavioral state using the Coma Recovery Scale-Revised (CRS-R). **Measure:** Correlating neural activity patterns (local field potentials and complexity) with behavioral responsiveness (measured using the Coma Recovery Scale-Revised). **Time Frame:** A maximum of 4 weeks after electrode implantation. **Description:** Effects of electrical stimulation on behavioral responsiveness will be measured using the Coma Recovery Scale Revised (CRS-R). **Measure:** Acute effects of electrical stimulation on behavioral responsiveness (measured using the Coma Recovery Scale-Revised). **Time Frame:** During electrical stimulation trials, performed in the first 4 weeks after electrode implantation. **Description:** Profiles of activity and reactivity identified during the acute stage of the disease will be correlated with long-term outcome measures mainly at 6m and 1y, using Coma Recovery Scale-Revised and Glasgow Outcome Scale-Extended. **Measure:** Correlation of neural activity profiles with long-term outcome (Coma Recovery Scale-Revised and Glasgow Outcome Scale-Extended) **Time Frame:** At 6 months and 1 year follow-up. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18 years old or older * Brain injury of any kind, with impaired consciousness or suspected seizures Exclusion Criteria: * \< 18 years old * Known pregnancy * Any condition that, in the judgement of the investigator, makes participation in the study unsafe or unfeasible (e.g., irreversible coagulopathy, large intracranial tumors, surgical technical problems...) **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Steven Smeijers, MD **Phone:** +32 16 34 48 00 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Tom Theys, MD PhD **Phone:** +32 16 34 48 00 **Role:** CONTACT #### Locations **Location 1:** **City:** Leuven **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Steven Smeijers, MD - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Tom Theys, MD PhD - **Role:** CONTACT **Country:** Belgium **Facility:** UZLeuven **State:** Vlaams-Brabant **Status:** RECRUITING **Zip:** 3000 #### Overall Officials **Official 1:** **Affiliation:** Universitaire Ziekenhuizen KU Leuven **Name:** Tom Theys, MD PhD **Role:** PRINCIPAL_INVESTIGATOR ## 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 - ID: D000009461 - Term: Neurologic Manifestations - ID: D000019954 - Term: Neurobehavioral Manifestations - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - 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: M5207 - Name: Brain Injuries - Relevance: HIGH - As Found: Brain Injury - ID: M628 - Name: Brain Injuries, Traumatic - Relevance: HIGH - As Found: Traumatic Brain Injury - ID: M15452 - Name: Seizures - Relevance: HIGH - As Found: Seizures - ID: M6468 - Name: Consciousness Disorders - Relevance: HIGH - As Found: Consciousness Disorders - 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 - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M21826 - Name: Neurobehavioral Manifestations - 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 - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001930 - Term: Brain Injuries - ID: D000070642 - Term: Brain Injuries, Traumatic - ID: D000012640 - Term: Seizures - ID: D000003244 - Term: Consciousness Disorders - ID: D000014947 - Term: Wounds and Injuries ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426602 **Brief Title:** mindBEAGLE: Unlocking Functional Communication for Patients With Disorders of Consciousness **Official Title:** Unlocking Functional Communication for Patients With Disorders of Consciousness With Innovative Brain Computer Interface Technology #### Organization Study ID Info **ID:** STUDY23080022 #### Organization **Class:** OTHER **Full Name:** University of Pittsburgh #### Secondary ID Infos **Domain:** UPMC Beckwith Institute **ID:** BECKW/12863 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-01-16 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** The Beckwith Institute #### Lead Sponsor **Class:** OTHER **Name:** Amy Wagner #### Responsible Party **Investigator Affiliation:** University of Pittsburgh **Investigator Full Name:** Amy Wagner **Investigator Title:** Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is Unapproved Device:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to test how effective the mindBEAGLE device is in allowing people who are unconscious (due to a brain injury or other condition) to communicate using brain waves to answer Yes/No questions. Participants will wear a cap that will be connected to a computer that measures brain waves, wrist bands that vibrate at different strengths, and ear phones that create different levels of loud tones and will be asked to associate Yes/No answers with the vibrations or tones. They will also be asked to "think about" moving different parts of their body to answer Yes or No. The mindBEAGLE device has already been proven effective for this kind of communication in a previous study, and the study team would like to trial it on a population of unconscious people who enter the UPMC Rehabilitation Institute to see if patients are able to be trained to use the device as part of their everyday inpatient rehabilitation until they are discharged, or until they are able to regain consciousness. **Detailed Description:** The team's research reflects an integrated clinical and research team who will characterize and implement an aggressive and innovative approach using brain-computer interface (BCI) technology for Disorders of Consciousness (DoC) evaluation, prognostication, and rehabilitation care. The work proposed strives for equity in accessing healthcare systems and technology effectively, even among vulnerable individuals with profound levels of disability due to their DoC state. The "gold-standard" for assessing cognitive capacity among patients with DoC relies on behavioral response observations and neuroimaging modalities. However, these approaches underestimate patients' capabilities. The current problem is that without other clinical data, rehabilitation teams rely solely on observable behavioral changes in patients' awareness of their environment in order to treat and improve communication. The project's challenge rests with implementing BCI focused assistive technology that identifies a unique and specific electrophysiological biomarker of cognitive and communication capacities that cannot be tapped using current clinical tools. If successful, this approach will allow clinical teams to initiate treatment and communication, avoiding therapeutic delays arising from traditional methods that require behavioral indicators needed to participate in functional communication. The P300 wave is a positive deflection in the human event-related potential. It is most commonly elicited in an "oddball" paradigm when a subject detects an occasional "target" stimulus in a regular train of standard stimuli. This project will compare standard awareness training methods used at the UPMC RI Brain Injury program with novel BCI research by using mindBEAGLE, a suite of P300 paradigms (vibrations, sound tones, and mental visualization) used for cognitive and communication assessment and treatment. European studies using the mindBEAGLE system with DoC patients reveal patients' cognitive and communication capabilities that impact current functional assessment and influence prognostication and recovery. The mindBEAGLE gives additional diagnostic data to enhance clinical neuroscience practice by showing reactions to stimuli that benefit from electroencephalogram (EEG) P300 use. However, clinical neuroscience implementation studies have not been conducted. Armed with more detailed and accurate assessments from this study, the investigators are confident that the clinical teams will be able to offer exciting rehabilitation treatments designed by UPMC RI treatment teams, patients, and families that leverage the mindBEAGLE interface for functional communication. Specifically, the EEG-based mindBEAGLE BCI suite will provide a practical platform for cognitive assessment of command following and a communication system for patients with DoC that will allow the research teams to offer more intensive, multidimensional rehabilitation treatments that meet the UPMC ideal of Life Changing Medicine. ### Conditions Module **Conditions:** - Disorders of Consciousness **Keywords:** - Coma - Locked-in syndrome - Vegetative state - Unresponsive wakefulness syndrome - Minimally conscious state ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Single arm Phase 2 experimental device efficacy clinical trial ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 15 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients identified as "disorders of consciousness" admitted to UPMC Rehabilitation Institute will be considered for the trial. As patients will not be able to communicate, health care proxy will provide consent. Participants will undergo 3 trials within a 7 day period (2-3 hours each ) to assess if they are responding to the device. **Intervention Names:** - Device: mindBEAGLE daily device use **Label:** mindBEAGLE trial participants **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - mindBEAGLE trial participants **Description:** If participants are considered responsive, they will continue to use the device daily for the remainder of their stay at inpatient rehab, or until they regain consciousness. **Name:** mindBEAGLE daily device use **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The ability to answer Yes/No questions at over above 60% accuracy using 1 of the following paradigms: 1. vibro-tactile (VT) stimulation with 3 tractors; 2. VT stimulation with 7 tractors; 3. motor imagery **Measure:** Neural and Multisensory DOC mindBEAGLE Initial Classification Accuracy Assessment **Time Frame:** 18 months **Description:** Among DOC patients who pass initial classification assessment: ability to communicate yes/no questions at or above 60% accuracy with one of the two P300 paradigms. mindBEAGLE P300 paradigm #1 1. Baseline - No response to yes/no questions 2. Change in baseline - Response to yes/no questions using mindBEAGLE mindBEAGLE P300 paradigm #2 1. Baseline - 0% accuracy on yes/no questions 2. Change in baseline - 60% or higher in response to yes/no questions. **Measure:** DOC mindBEAGLE Communication Assessment **Time Frame:** 18 months **Description:** Clinicians agree that mindBEAGLE is feasible to implement with DOC patients in the inpatient setting. **Measure:** Acceptability of mindBEAGLE treatment by clinical staff. **Time Frame:** Within 2 weeks Post-intervention **Description:** Family/Caregivers of DOC patient agree that the mindBEAGLE was beneficial. **Measure:** Acceptability of mindBEAGLE treatment by families of DOC patients. **Time Frame:** Within 2 weeks Post-intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 18-50 * Medically able to tolerate Disorders of Consciousness (DoC) rehabilitation program as determined by UPMC Physicians * Clinically assessed capacity for functional improvement in the rehabilitation environment * Measuring improvements with pharmacological stimulation (using JFK Coma Recovery Scale) * Electrophysiological prognostic testing confirming brain activity. Exclusion Criteria: * Coma * Bilateral non-response with standard electrophysiological studies * Medical instability * Open scalp wound **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Amy K. Wagner, M.D. **Phone:** 412-648-6666 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Katherine Hill, Ph.D. **Phone:** (412) 647-1310 **Role:** CONTACT #### Locations **Location 1:** **City:** Pittsburgh **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Vince Schiappa, MS, ATP - **Phone:** 412-647-1310 - **Role:** CONTACT **Country:** United States **Facility:** UPMC Center for Assistive Technology **State:** Pennsylvania **Zip:** 15213 **Location 2:** **City:** Pittsburgh **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Amy Wagner, M.D. - **Phone:** 412-648-6666 - **Role:** CONTACT **Country:** United States **Facility:** UPMC Rehabilitation Institute **State:** Pennsylvania **Zip:** 15219 #### Overall Officials **Official 1:** **Affiliation:** University of Pittsburgh **Name:** Amy Wagner, M.D. **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** University of Pittsburgh **Name:** Katherine Hill, Ph.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** It is possible that the investigators may use the information obtained from this study in other future research studies. All information disseminated to outside collaborators or entities will be done in a de-identified manner so as to mitigate a breach of confidentiality and protect PHI/PII. Data will be coded using unique identifying numbers that do not contain PII. Any links to PII will be kept locally but will not be disseminated to outside collaborators. Any data shared with outside institutions or collaborators will be conducted under the guidelines of an approved data use agreement between the University of Pittsburgh and the collaborating entity. This includes any plans to publish published peer-reviewed manuscripts. **IPD Sharing:** YES ### References Module #### References **Citation:** Kondziella D, Amiri M, Othman MH, Beghi E, Bodien YG, Citerio G, Giacino JT, Mayer SA, Lawson TN, Menon DK, Rass V, Sharshar T, Stevens RD, Tinti L, Vespa P, McNett M, Venkatasubba Rao CP, Helbok R; Curing Coma Campaign Collaborators. Incidence and prevalence of coma in the UK and the USA. Brain Commun. 2022 Sep 1;4(5):fcac188. doi: 10.1093/braincomms/fcac188. eCollection 2022. **PMID:** 36132425 **Citation:** Godbolt AK, Deboussard CN, Stenberg M, Lindgren M, Ulfarsson T, Borg J. Disorders of consciousness after severe traumatic brain injury: a Swedish-Icelandic study of incidence, outcomes and implications for optimizing care pathways. J Rehabil Med. 2013 Sep;45(8):741-8. doi: 10.2340/16501977-1167. **PMID:** 24002309 **Citation:** Mainali S, Aiyagari V, Alexander S, Bodien Y, Boerwinkle V, Boly M, Brown E, Brown J, Claassen J, Edlow BL, Fink EL, Fins JJ, Foreman B, Frontera J, Geocadin RG, Giacino J, Gilmore EJ, Gosseries O, Hammond F, Helbok R, Claude Hemphill J, Hirsch K, Kim K, Laureys S, Lewis A, Ling G, Livesay SL, McCredie V, McNett M, Menon D, Molteni E, Olson D, O'Phelan K, Park S, Polizzotto L, Javier Provencio J, Puybasset L, Venkatasubba Rao CP, Robertson C, Rohaut B, Rubin M, Sharshar T, Shutter L, Sampaio Silva G, Smith W, Stevens RD, Thibaut A, Vespa P, Wagner AK, Ziai WC, Zink E, I Suarez J; Curing Coma Campaign collaborators. Proceedings of the Second Curing Coma Campaign NIH Symposium: Challenging the Future of Research for Coma and Disorders of Consciousness. Neurocrit Care. 2022 Aug;37(1):326-350. doi: 10.1007/s12028-022-01505-3. Epub 2022 May 10. Erratum In: Neurocrit Care. 2022 Jun 17;: **PMID:** 35534661 **Citation:** Torres-Saavedra PA, Winter KA. An Overview of Phase 2 Clinical Trial Designs. Int J Radiat Oncol Biol Phys. 2022 Jan 1;112(1):22-29. doi: 10.1016/j.ijrobp.2021.07.1700. Epub 2021 Aug 4. **PMID:** 34363901 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019954 - Term: Neurobehavioral Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental 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: 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: M6468 - Name: Consciousness Disorders - Relevance: HIGH - As Found: Disorders of Consciousness - ID: M6356 - Name: Coma - Relevance: LOW - As Found: Unknown - ID: M2155 - Name: Locked-In Syndrome - 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: 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: T3491 - Name: Locked-in Syndrome - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003244 - Term: Consciousness Disorders ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426589 **Brief Title:** Exercise and Nutrition in the Mental Health of the Older Adult Population **Official Title:** Resistance Training and Mediterranean Diet in the Mental Health of the Older Adult Population: a Randomized Controlled Clinical Trial #### Organization Study ID Info **ID:** UJA.2024 #### Organization **Class:** OTHER **Full Name:** University of Jaén ### Status Module #### Completion Date **Date:** 2024-01-26 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-01-19 **Type:** ACTUAL #### Start Date **Date:** 2023-10-23 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Jaén #### Responsible Party **Investigator Affiliation:** University of Jaén **Investigator Full Name:** Agustín Aibar Almazán **Investigator Title:** Principal investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Resistance exercise and the Mediterranean diet are complementary, evidence-based approaches to improving physical and mental health throughout all stages of life. For older adults, maintain flexibility, muscle strength, balance and posture, reducing the risk of falls and injuries; They relieve chronic pain, improve sleep quality, and reduce stress and anxiety. For young people, they improve concentration, attention and memory, reduce stress and anxiety, promote a positive body image and increase self-esteem. Overall benefits include promoting the mind-body connection, facilitating healthy aging, and being accessible and adaptable to various individual and socioeconomic needs. The main components of the Mediterranean diet are: high in fruits, vegetables, legumes, nuts, whole grains, fish and olive oil; moderate in dairy and red wine; and low in red meat and processed products. Benefits for older adults include reducing the risk of cardiovascular disease, decreasing chronic diseases and pro-inflammatory factors, and preventing obesity and cognitive decline. The overall impact improves bone and cardiovascular health, and strengthens the immune system. The combination of resistance exercise and a Mediterranean diet offers a comprehensive approach to improving health and well-being throughout life, promoting physical and mental health, facilitating active and healthy aging, and being accessible and beneficial for people of all socioeconomic backgrounds ### Conditions Module **Conditions:** - Older Adults ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 108 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The control group (CG) will not undergo treatment, which will be evaluated in the pre- and post-phase of the study. Participants assigned to this group will receive general advice on the positive effects of regular physical activity, and they will be given the guide of recommendations for the promotion of physical activity. **Label:** Control Group **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** The experimental group (EG), after an initial evaluation, will be subjected to a physical training program based on the resistance training, for 12 weeks with 2 weekly sessions (Tuesday and Thursday), with a duration of 45 minutes per session. Once the intervention is finished, you will undergo a final evaluation again to see if there is a difference or not with the results obtained at the beginning. In addition to the resistance training intervention, the experimental group received a Mediterranean diet protocol. **Intervention Names:** - Other: Resistence training and mediterranean diet **Label:** Experimental Group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental Group **Description:** Resistance training. Subjects assigned to the experimental group participated in resistance program twice a week (on Tuesdays and Thursdays) for a period of 12 weeks, totaling 24 sessions of 60 minutes each. Each session during this time was divided into three clearly differentiated parts: i) 5-minute warm-up comprised of a series of gentle, low-intensity exercises designed to gradually prepare the muscles and joints of older adults for the main exercise. Mediterranean Diet. In addition to the resistance intervention, the experimental group received a Mediterranean diet protocol based on the study by Ismail et al. \[34\] with the following meal plan: i) carbohydrates constituted 50% of daily intake; ii) fats repre-sented 35%; and iii) proteins accounted for 15%. **Name:** Resistence training and mediterranean diet **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** This was measured using the 14-item Mediterranean Diet Adherence Questionnaire (MEDAS) questionnaire, developed by the Prevention with Mediterranean Diet (PREDIMED) researchers. The questionnaire consists of 12 queries regarding how often various foods are eaten and two additional questions concerning typical eating habits in Spain \[35\]. Each question could be answered with a score of either zero or one. The total possible score ranged from 0 to 14, with a total of 9 or higher signifying sufficient compliance with the Mediterranean diet. **Measure:** Adherence to the Mediterranean Diet **Time Frame:** Up to twelve weeks **Description:** To evaluate anxiety and depression levels, the Hospital Anxiety and Depression Scale (HADS) was used \[36,37\]. This instrument is frequently used in populations of older adults who are not institutionalized \[38\] and includes 14 questions, divided equally between anxiety (even questions) and depression (even questions). Items are scored on a scale of 0 to 3, resulting in a total score range of 0 to 21 for both anxiety and depression, with a higher number indicating a greater presence of symptoms. Sleep quality **Measure:** Anxiety and depression **Time Frame:** Up to twelve weeks **Description:** The Pittsburgh Sleep Quality Index (PSQI) \[39,40\], a widely recognized tool for the assessment of sleep quality, was the questionnaire selected for this task. The PSQI includes 19 self-report items and 5 additional items that must be completed by the participant's bed partner or roommate (the latter are used only to obtain clinical data). From these items, a global score is calculated and seven dimensions or areas are evaluated: sleep quality; time to fall asleep; sleep duration; sleep efficiency; problems during sleep; consumption of sleep medication; and daytime functioning problems. The total score on the PSQI ranges from 0 to 21, with higher scores indicating poor sleep quality. **Measure:** Sleep quality **Time Frame:** Up to twelve weeks **Description:** The measurement of perceived stress was carried out using the Perceived Stress Scale (PSS) \[41\] in its version for the Spanish language \[42\], an instrument composed of 14 questions that determines the degree of stress felt in the last month. This questionnaire uses a response system based on a five-point scale (0 = never, 1 = almost never, 2 = occasionally, 3 = frequently, 4 = very frequently). To calculate the total score on the PSS, the response values for items 4, 5, 6, 7, 9, 10, and 13 are reversed (so that 0 becomes 4, 1 becomes 3, etc.) and Then all the items are added. The score ranges from 0-56, with a higher score on the scale indicating a higher level of perceived stress. **Measure:** Perceived stress **Time Frame:** Up to twelve weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Were 65 years or older were eligible for the study * Had not been part of any resistance program in the last 12 months * They could understand and follow the instructions, activities and protocols of the exercise program. Exclusion Criteria: * They suffered from any systemic condition (e.g., neurodegenerative, musculoskeletal, or visual diseases) that prevented them from performing the exercises. * Had any vestibular disease or disorder * Consumed medications that influenced the central nervous system, balance or coordination (for example, antidepressants, vestibular sedatives or anxiolytics). **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Jaén **Country:** Spain **Facility:** Agustín Aibar Almazán ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426576 **Brief Title:** Load Limits After Orthopaedic Surgery: Biofeedback vs. Conventional Method (AppPWB) **Official Title:** Application of Load Limits After Orthopaedic Surgery With Biofeedback-based Instructions Compared to a Conventional Method #### Organization Study ID Info **ID:** 2024-00106; mu24Mauch #### Organization **Class:** OTHER **Full Name:** University Hospital, Basel, Switzerland ### Status Module #### Completion Date **Date:** 2026-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-01 **Type:** ESTIMATED #### Start Date **Date:** 2025-03 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Basel, Switzerland #### 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 aim of this single-centre prospective randomized-controlled clinical trial is to assess whether patients adhere to prescribed weight bearing limits after surgical orthopaedic or traumatological interventions more accurately after instruction using a biofeedback method than using the standard method. **Detailed Description:** Partial weight bearing, commonly prescribed post-surgery in orthopaedics and traumatology, aims to stimulate healing while preventing overloading. Partial weight bearing refers to that the patient is only allowed to put 10 to 50% of their body weight on the affected limb. The most commonly used method for instructing partial weight bearing with the patient is using a personal scale. This means that the patient can only exercise in a static position and the perceived load must be transferred to dynamic activities of daily living without further feedback. Previous reports indicate that patients often struggle to adhere to prescribed partial weight-bearing limits, frequently exceeding the specified load by 100% or more. However, when additional feedback was incorporated into training, approximately 90% of subjects successfully adhered to the partial load. Portable or wearable measuring systems, such as pressure-sensitive insoles, offer feedback during dynamic tasks, facilitating a smoother transition to daily activities. Unlike the standard one-time instruction using a scale, these systems provide repeated feedback at each step, promoting a higher frequency of exercises. This aids patients in developing a better sense of the correct load. This single-centre prospective randomized-controlled clinical trial aims to investigate the effectiveness of pressure insoles connected to a smartphone via Bluetooth and operated using an app in improving partial weight bearing adherence. The insoles provide direct feedback through acoustic and visual signals if the affected leg is overloaded, possibly leading to a lower proportion of steps over the load limit compared to those without feedback. Participants are randomized into either the intervention group (dynamic condition - plantar pressure insoles) or the control group (static condition - standard one-off instruction using a scale). The primary objective is to determine whether the proportion of steps exceeding the weight bearing limit is lower in the intervention group compared to the control group 2 weeks after surgery. Secondary objectives include assessing subjective ratings of the permitted load, perceived pain, and mobility. Additionally, the trial hypothesizes that patients using the insoles can estimate applied load more accurately. The intervention group will also provide feedback on the usability of the app and insoles. The results of this trial will contribute to enhancing postoperative treatment of patients undergoing orthopaedic surgery, thereby improving treatment outcomes and optimizing therapy regimens. ### Conditions Module **Conditions:** - Surgery **Keywords:** - Orthopaedic surgery - Partial weight bearing - Portable measurement systems - Plantar pressure insoles - Biofeedback function ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The control group receives instructions on partial weight bearing using the standard method. **Intervention Names:** - Other: Standard one-off instruction using a scale **Label:** Control group **Type:** OTHER #### Arm Group 2 **Description:** The intervention group receives instructions on partial weight bearing using a plantar pressure sole inserted into the shoe that measures the force/weight applied to the foot and indicates the applied weight to the patient both visually and acoustically via a smartphone app. **Intervention Names:** - Device: Plantar pressure insoles **Label:** Intervention group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Control group **Description:** The permitted weight is demonstrated to the patient once using a scale in the static position. The patient repeatedly places the foot with the permitted weight on a scale in order to develop a feeling for the load. After this exercise in the static position, the patient applies the perceived load to dynamic activities of daily living without receiving any feedback. The instruction is given by a trained physiotherapist. Simultaneously with the instruction, the effective weight applied on the leg will be measured using instrumented insoles without any feedback. **Name:** Standard one-off instruction using a scale **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Intervention group **Description:** The insoles are used in both static and dynamic conditions such as walking straight along the hallway or walking stairs if applicable. Initial instruction is given by a trained physiotherapist and will be continuously applied at home using the smartphone app for 5 out of 7 days per week during the first 2 weeks after surgery. **Name:** Plantar pressure insoles **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** After 2 weeks of continuous use of the feedback-providing insoles by the intervention group, the adherence to load limits is evaluated at the follow-up visit. This assessment aims to determine if the intervention group adheres better to the prescribed weight-bearing limits compared to the control group, which did not receive feedback during this period. Both groups have the proportion of steps (%) exceeding the prescribed weight-bearing limit on the injured leg while walking assessed using instrumented insoles. **Measure:** Proportion of steps (%) over of the prescribed weight bearing limit on the injured leg while walking, assessed with the instrumented insoles. **Time Frame:** At 2 weeks post-surgery #### Secondary Outcomes **Description:** To assess the pain level, the numeric analog scale is used. Patients are asked to rate their pain on a scale from 0 to 10, where 0 indicates no pain while 10 indicates the worst possible pain. **Measure:** Assessment of perceived pain **Time Frame:** Baseline and at 2 weeks post-surgery **Description:** To assess the physical activity, the UCLA Activity Scale(UCLA) is used The UCLA Activity Scale consists of questions related to different activities, and patients rate their ability to perform each activity on a scale from 1 to 10, with higher scores indicating greater activity levels. **Measure:** Assessment of physical activity **Time Frame:** Baseline and at 2 weeks post-surgery **Description:** To assess the mobility, the Life Space Questionnaire and Parker Mobility Score are used. The former asks respondents to report on their frequency of movement and the distance traveled within various zones, such as within their home, neighborhood, and beyond. The latter evaluates an individual's ability to perform three basic mobility tasks. A score is given to each activity on a 4 point scale (0 - not at all, 1 - assistance of one person, 2 - with an aid, 3 - no difficulty and no aid) and then combined to provide a final score between 0 and 9, where 9 is independent with no aid in all three activities, and 0 is not able to carry out any of the activities. **Measure:** Assessment of mobility **Time Frame:** Baseline and at 2 weeks post-surgery **Description:** The health-related quality of life is assessed using the EuroQol-5 Dimensions (EQ-5D). It is a standardized questionnaire used to assess an individual's health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has three levels of severity (no problems, some problems, extreme problems), allowing for the classification of 243 unique health states. **Measure:** Assessment of the quality of life **Time Frame:** Baseline and at 2 weeks post-surgery **Description:** Patients are asked to estimate the applied load. **Measure:** Assessment of perceived load applied **Time Frame:** At 2 weeks post-surgery **Description:** The intervention group is asked to provide feedback on the usability of the app and insoles using a questionnaire. **Measure:** Assessment of the usability of the planar pressure insoles (intervention group only) **Time Frame:** At 2 weeks post-surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with prescribed partial weight bearing (joint-independent) for at least 2 weeks * Unilateral injury of the lower extremity * Having their own smartphone * Age 18 years and older Exclusion Criteria: * Patients with prescribed full weight bearing * Patients with prescribed complete unloading * Patients with prescribed self-selected loading "according to pain" * Bilateral injuries of lower extremities * Upper extremity injuries precluding the use of crutches * Use of walking aids prior to injury * Neurological conditions affecting gait * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc., * Previous enrolment in a clinical trial * Body mass \> 135 kg * Age under 18 years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Marlene Mauch, Dr. **Phone:** +41 61 26 59444 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Mandy Mathys **Phone:** +41 61 55 65 279 **Role:** CONTACT #### Locations **Location 1:** **City:** Basel **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Marlene Mauch, Dr. - **Phone:** +41 61 26 59444 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Mandy Mathys - **Phone:** +41 61 55 65 279 - **Role:** CONTACT ***Contact 3:*** - **Name:** Marlene Mauch, Dr. - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Svenja Schneider - **Role:** SUB_INVESTIGATOR **Country:** Switzerland **Facility:** Department of Orthopaedics and Traumatology, University Hospital Basel, Bethesda Spital Basel **State:** Basel-Stadt **Zip:** 4052 #### Overall Officials **Official 1:** **Affiliation:** Department of Orthopaedics and Traumatology, University Hospital Basel **Name:** Marlene Mauch, Dr. **Role:** PRINCIPAL_INVESTIGATOR ## 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: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426563 **Brief Title:** MWA vs RFA for the Treatment of Moderate-sized Benign Thyroid Nodules **Official Title:** Microwave Ablation Versus Radiofrequency Ablation for the Treatment of Moderate-sized Benign Thyroid Nodules, a Randomized Controlled Trial #### Organization Study ID Info **ID:** UW 24-141 #### Organization **Class:** OTHER **Full Name:** The University of Hong Kong ### Status Module #### Completion Date **Date:** 2028-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The University of Hong Kong #### Responsible Party **Investigator Affiliation:** The University of Hong Kong **Investigator Full Name:** Man Him Matrix Fung **Investigator Title:** Clinical 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:** Thyroid nodule is a common condition that affects up to 60% of the population. There is an estimated 10% lifetime probability of developing a thyroid nodule. Although most thyroid nodules are benign, up to 10-15% can enlarge to cause compressive symptoms including neck pressure and discomfort, dysphagia, dyspnea, and dysphonia. The conventional treatment for these benign but problematic nodules has been thyroidectomy. Although generally a low risk operation, thyroidectomy is associated with some risk for recurrent laryngeal nerve injury, bleeding, infection, and need for thyroid hormone supplementation. Since the early 2000s, ultrasound-guided percutaneous thermal ablation has emerged as a potential alternative treatment to surgery for benign thyroid nodules. Of the myriad ablation methods, the most commonly used techniques are radiofrequency ablation (RFA) and microwave ablation (MWA). \[1-3\] A growing body of evidence shows that RFA is an effective treatment for benign solid thyroid nodules, toxic adenomas, and thyroid cysts resulting in overall volume reduction ranges of 40-80% at 1 year, with durable resolution of compressive and hyperthyroid symptoms. However, RFA is not without its limitations. Radiofrequency waves can be limited by the heat sink effect and tissue char leading to longer procedure times and potentially less optimal outcomes in larger, hypervascular, and/or more cystic nodules. Microwave ablation (MWA) is another ablative technique that uses electromagnetic energy waves to cause tissue hyperthermia and coagulative necrosis. It generally causes higher ablation temperatures than RFA and is less subject to the heat sink effect, and therefore can facilitate more efficient ablation procedures. Current evidence comparing RFA versus MWA for thyroid ablation was limited and was either retrospective, non-randomized \[4-9\], under-powered, or with an unequal baseline. The results from these studies were also conflicting, suggesting suboptimal quality of evidence and bias due to non-standardized technique of ablation across studies. To date, there is no randomized controlled trial comparing the efficacy and safety of RFA versus MWA for the treatment of benign thyroid nodules. Given the higher ablation temperatures, freedom from heat sink effect, and no influence from impedance changes during ablation, MWA may achieve different treatment efficacy. ### Conditions Module **Conditions:** - Thyroid Nodule \(Benign\) - Ablation Therapy **Keywords:** - Ablation therapy - Thyroid nodule - benign - RFA - MWA ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** One group is for radiofrequency ablation treatment (RFA), another group is for microwave ablation treatment (MWA) ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants who are undergo thyroid nodule treatment by RFA **Intervention Names:** - Procedure: Ablation treatment of thyroid nodule **Label:** Radiofrequency ablation treatment (RFA) to thyroid nodule **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Participants who are undergo thyroid nodule treatment by MWA **Intervention Names:** - Procedure: Ablation treatment of thyroid nodule **Label:** Microwave ablation treatment (MWA) to thyroid nodule **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Microwave ablation treatment (MWA) to thyroid nodule - Radiofrequency ablation treatment (RFA) to thyroid nodule **Description:** Use Radiofrequency or Microwave ablation device to treat thyroid nodule **Name:** Ablation treatment of thyroid nodule **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Measure:** To measure the volume reduction ratio (VRR) of the first ablated nodule at each procedure at 12-months post-procedure **Time Frame:** 12 months #### Secondary Outcomes **Measure:** To measures nodule recurrence rate **Time Frame:** 12-24 months **Measure:** To measures thyroid nodule regrowth rate **Time Frame:** 12-24 months **Description:** To measure cosmetic score from 1 to 4 (1 is No palpable goitre, 2 is Palpable goitre but invisible, 3 is Goitre only visible to experienced clinician, 4 is Easily visible goitre) **Measure:** To measure cosmetic score by investigator (1-4) **Time Frame:** 12-24 months **Description:** compressive symptom score from 0 (no compression feeling) to 100 (the most compressive) **Measure:** To measure the compressive symptom scores (from 0 - 100) **Time Frame:** 12-24 months **Description:** Swallowing Impairment Index (SIS-6) is an assessment tool about swallowing dysfunction and symptom. It comprises six question items ranging from 0 (no impairment) to 24 (maximum impairment) **Measure:** To measure swallowing impairment scores by questionnaire (SIS-6) **Time Frame:** 12-24 months **Description:** 0 is no pain, 10 is the most painful **Measure:** To measure pain score (0-10) after ablation treatment **Time Frame:** 12-24 months **Description:** SF-12(v2) is an assessment tool about quality of life. It comprises 12 question items ranging from 11 (worst quality of life) to 56 (best quality of life). **Measure:** Change of quality of life by SF12 ver 2 **Time Frame:** 12-24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Adult patients \&gt;/=18 years of age 2. Nodule maximal diameter ≥2cm and nodule volume \&lt;20ml 3. Nodule being predominantly solid (≥80% solid) 4. Confirmed benign nature of nodules, either by : two benign fine needle biopsies, with the most recent biopsy performed within 1 year of enrollment in study or one benign fine needle biopsy and low suspicion characteristics on ultrasound 5. Both functional and non-functional nodules are eligible. Exclusion Criteria: 1. Cytologically indeterminate nodules 2. Nodules with substernal extension or posterior extension that cannot be viewed sufficiently with ultrasound 3. current pregnancy or cardiac arrhythmias; presence of pacemaker or any medical condition that renders patient unfit for thermal ablation **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Man Him, Matrix Fung, MBBS **Phone:** +852-22554232 **Role:** CONTACT #### Locations **Location 1:** **City:** Hong Kong **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Man Him, Matrix Fung, MBBS - **Phone:** +852-22554232 - **Role:** CONTACT ***Contact 2:*** - **Name:** Man Him, Matrix Fung, MBBS - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Hong Kong **Facility:** Queen Mary Hospital **Status:** RECRUITING **Zip:** 00000 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Lang BHH, Fung MMH. Safety and Efficacy of Single-Session Radiofrequency Ablation Treatment for Benign Non-toxic Multinodular Goiter. World J Surg. 2022 Jul;46(7):1704-1710. doi: 10.1007/s00268-022-06527-8. Epub 2022 Mar 21. **PMID:** 35313358 **Citation:** Cheng Z, Che Y, Yu S, Wang S, Teng D, Xu H, Li J, Sun D, Han Z, Liang P. US-Guided Percutaneous Radiofrequency versus Microwave Ablation for Benign Thyroid Nodules: A Prospective Multicenter Study. Sci Rep. 2017 Aug 25;7(1):9554. doi: 10.1038/s41598-017-09930-7. **PMID:** 28842651 **Citation:** Wu W, Gong X, Zhou Q, Chen X, Chen X. Ultrasound-Guided Percutaneous Microwave Ablation for Solid Benign Thyroid Nodules: Comparison of MWA versus Control Group. Int J Endocrinol. 2017;2017:9724090. doi: 10.1155/2017/9724090. Epub 2017 Nov 23. **PMID:** 29333159 **Citation:** He L, Zhao W, Xia Z, Su A, Li Z, Zhu J. Comparative efficacy of different ultrasound-guided ablation for the treatment of benign thyroid nodules: Systematic review and network meta-analysis of randomized controlled trials. PLoS One. 2021 Jan 20;16(1):e0243864. doi: 10.1371/journal.pone.0243864. eCollection 2021. **PMID:** 33471820 **Citation:** Hu K, Wu J, Dong Y, Yan Z, Lu Z, Liu L. Comparison between ultrasound-guided percutaneous radiofrequency and microwave ablation in benign thyroid nodules. J Cancer Res Ther. 2019;15(7):1535-1540. doi: 10.4103/jcrt.JCRT_322_19. **PMID:** 31939434 **Citation:** Guo DM, Chen Z, Zhai YX, Su HH. Comparison of radiofrequency ablation and microwave ablation for benign thyroid nodules: A systematic review and meta-analysis. Clin Endocrinol (Oxf). 2021 Jul;95(1):187-196. doi: 10.1111/cen.14438. Epub 2021 Mar 2. **PMID:** 33556187 **Citation:** Jin H, Fan J, Lu L, Cui M. A Propensity Score Matching Study Between Microwave Ablation and Radiofrequency Ablation in Terms of Safety and Efficacy for Benign Thyroid Nodules Treatment. Front Endocrinol (Lausanne). 2021 Mar 9;12:584972. doi: 10.3389/fendo.2021.584972. eCollection 2021. **PMID:** 33767666 **Citation:** Kim JH, Baek JH, Lim HK, Ahn HS, Baek SM, Choi YJ, Choi YJ, Chung SR, Ha EJ, Hahn SY, Jung SL, Kim DS, Kim SJ, Kim YK, Lee CY, Lee JH, Lee KH, Lee YH, Park JS, Park H, Shin JH, Suh CH, Sung JY, Sim JS, Youn I, Choi M, Na DG; Guideline Committee for the Korean Society of Thyroid Radiology (KSThR) and Korean Society of Radiology. 2017 Thyroid Radiofrequency Ablation Guideline: Korean Society of Thyroid Radiology. Korean J Radiol. 2018 Jul-Aug;19(4):632-655. doi: 10.3348/kjr.2018.19.4.632. Epub 2018 Jun 14. **PMID:** 29962870 **Citation:** Huh JY, Baek JH, Choi H, Kim JK, Lee JH. Symptomatic benign thyroid nodules: efficacy of additional radiofrequency ablation treatment session--prospective randomized study. Radiology. 2012 Jun;263(3):909-16. doi: 10.1148/radiol.12111300. Epub 2012 Mar 21. **PMID:** 22438360 **Citation:** Lim HK, Lee JH, Ha EJ, Sung JY, Kim JK, Baek JH. Radiofrequency ablation of benign non-functioning thyroid nodules: 4-year follow-up results for 111 patients. Eur Radiol. 2013 Apr;23(4):1044-9. doi: 10.1007/s00330-012-2671-3. Epub 2012 Oct 25. **PMID:** 23096937 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004700 - Term: Endocrine System Diseases - ID: D000013964 - Term: Thyroid Neoplasms - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000006258 - Term: Head and Neck Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms ### Condition Browse Module - Browse Leaves - ID: M16718 - Name: Thyroid Diseases - Relevance: HIGH - As Found: Thyroid - ID: M18986 - Name: Thyroid Nodule - Relevance: HIGH - As Found: Thyroid Nodules - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M16723 - Name: Thyroid Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016606 - Term: Thyroid Nodule - ID: D000013959 - Term: Thyroid Diseases ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426550 **Brief Title:** Clinical and Microbiological Evaluation of Laser Therapy in the Treatment of Periodontal Disease in Stages III and IV **Official Title:** Clinical and Microbiological Evaluation of Laser Therapy in the Treatment of Periodontal Disease in Stages III and IV #### Organization Study ID Info **ID:** 78007624.4.0000.5626 #### Organization **Class:** OTHER **Full Name:** Universidade Federal Fluminense ### Status Module #### Completion Date **Date:** 2026-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-02 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-06 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universidade Federal Fluminense #### Responsible Party **Investigator Affiliation:** Universidade Federal Fluminense **Investigator Full Name:** Gabriela Alessandra da Cruz Galhardo Camargo **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The aim of this clinical trial is to evaluate photodynamic therapy and photobiomodulation in the periodontitis treatment. To evaluate the clinical and microbiological response of conventional periodontal treatment associated with photodynamic therapy and photobiomodulation with red or infrared laser. Participants will receive periodontal treatment carried out with the use 0.005% methylene blue and laser therapy (photodynamic therapy), associated with conventional periodontal treatment, as well as the use of photobiomodulation with red or infrared laser associated with conventional periodontal treatment in participants with periodontitis. So, twenty periodontitis patients will be selected and separated in two groups compared with placebo. Clinical and microbiological parameters will be evaluated at baseline and 3 months after periodontal treatment: plaque Index, bleeding on probe, probing depth, gingival recession and clinical attachment level. **Detailed Description:** Periodontitis is a chronic, inflammatory and multifactorial disease, caused by an interaction between debiotic biofilm and its products and an exacerbated host response, leading to the progressive destruction of the supporting periodontium (bone, cement and periodontal ligament), causing loss of clinical attachment. and radiographic, bleeding on probing and periodontal pocket formation. Periodontal disease has a high prevalence and is one of the main causes of edentulism, with a great negative impact on chewing function, aesthetics and quality of life related to oral health. It is, therefore, considered a serious public health problem. Conventional periodontal therapy consists of scaling and root planing (SRP) and control of supragingival plaque, but in some cases it has been shown to be ineffective in treating periodontitis, especially in difficult to access areas such as furcations and deep pockets. These cases benefit from adjuvant therapies, such as laser therapy, to help heal periodontal tissues, reduce microorganisms and improve clinical parameters. Photobiomodulation and photodynamic therapy have been widely applied in the treatment of periodontal disease, due to their clinical, cellular and bactericidal effects. When associated with conventional periodontal therapy, its benefits increase, promoting a significant reduction in probing depth, number of deep pockets and bleeding. Furthermore, significant reduction of periodontopathogens and Candida albicans can be observed in the literature after photobiomodulation and photodynamic therapy. Despite the benefits found when different laser therapy protocols are used in periodontal treatment, due to the lack of studies with high methodological quality and weak evidence in the existing literature, more studies are needed to prove their effects, establish appropriate protocols and evaluate the antimicrobial potential in periodontopathogens, which remains debatable, as recent systematic reviews point out. The direct benefits of this study are the treatment of periodontal disease for the participants and for the scientific community to indicate new forms of periodontal therapy using different protocols of laser therapy associated with periodontal instrumentation. All tooth pocket sites in all groups will receive treatment. ### Conditions Module **Conditions:** - Periodontitis - Periodontitis, Adult **Keywords:** - Periodontal Diseases - Periodontal Pocket - Laser Therapy - Methylene Blue ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SEQUENTIAL **Intervention Model Description:** Clinical, laboratory, longitudinal split-mouth study carried out in humans. ##### Masking Info **Masking:** TRIPLE **Masking Description:** Randomization will be carried out by a blind clinician for the initial assessment of participants, using a computer program (Spyder 5.5.4), in which each patient will be randomly selected to define the site to receive one of the treatments. Next, gels will be encoded in a syringe and applied by a researcher blind to the sites and reagents, each of the 4 sites will receive one of the following treatments: 1 - photosensitization with 0.005% AM gel (Fórmula e Ação Farmácia, São Paulo, SP, Brazil) for 5 minutes, and apply photodynamic therapy with a red laser; 2 - photobiomodulation with red laser; 3 - photobiomodulation with infrared laser; and 4 - control, application of saline gel and, after 5 minutes, simulate the application of the laser, with the device in inactive mode, in order to maintain blinding of the patients (control). In groups 2 and 3, as no gel will be applied, the application of the gel with an empty syringe will be simulated, to keep patients blind **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** After conventional periodontal treatment, photosensitization will be performed with 0.005% methylene blue gel (Fórmula e Ação Farmácia, São Paulo, SP, Brazil) for 5 minutes, and photodynamic therapy will be applied with a red laser (660 nm) using a DuoⓇ laser (MMOptics, São Carlos, SP, Brazil) with the optical fiber inside the periodontal pocket in back and forth movements, according to the manufacturer's protocol, for 90s, 9 joules of energy, dose of 508.5J/cm2, irradiance of 5.65W/cm2 and power of 100mW. **Intervention Names:** - Procedure: Periodontal treatment **Label:** Photodynamic therapy and 0.005% methylene blue (PDT) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** After conventional periodontal treatment, photobiomodulation will be performed with a red laser (660 nm) using a DuoⓇ laser (MMOptics, São Carlos, SP, Brazil) with the optical fiber inside the periodontal pocket in back and forth movements, according to the manufacturer's protocol, for 90s, 9 joules of energy, dose of 508.5J/cm2, irradiance of 5.65W/cm2 and power of 100mW. As no gel will be applied, the application of the gel with an empty syringe will be simulated, and waited 5 minutes, to keep patients blind to the intervention received. **Intervention Names:** - Procedure: Periodontal treatment **Label:** Photobiomodulation with a red laser (PBMV) **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** After conventional periodontal treatment, photobiomodulation will be performed with an infrared laser (808 nm) using a DuoⓇ laser (MMOptics, São Carlos, SP, Brazil) with the optical fiber inside the periodontal pocket in back and forth movements, according to the manufacturer's protocol, for 90s, 9 joules of energy, dose of 508.5J/cm2, irradiance of 5.65W/cm2 and power of 100mW. As no gel will be applied, the application of the gel with an empty syringe will be simulated, and waited 5 minutes, to keep patients blind to the intervention received. **Intervention Names:** - Procedure: Periodontal treatment **Label:** Photobiomodulation with an infrared laser (PBMIV) **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** After conventional periodontal treatment, saline gel will be applied in the periodontal pocket and, after 5 minutes, the laser application will be simulated, with the device in inactive mode, in order to maintain blinding of the patients. **Intervention Names:** - Procedure: Periodontal treatment **Label:** Saline solution - Control (C) **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Photobiomodulation with a red laser (PBMV) - Photobiomodulation with an infrared laser (PBMIV) - Photodynamic therapy and 0.005% methylene blue (PDT) - Saline solution - Control (C) **Description:** An experienced periodontist will access clinical periodontal parameters, including plaque index, bleeding on probing, pocket probing depth, gingival recession, clinical attachment level using a periodontal probe, at six sites per tooth at all teeth, excluding third molars. Conventional periodontal treatment, scaling and root planning, will be performed with ultrasound (Dabi Atlante, Rio de Janeiro, RJ, Brazil) complemented with Gracey curettes (Golgran, São Caetano do Sul, SP, Brazil) on each patient under local anesthesia. The maintenance therapy will include professional plaque control and scaling and root planning in recurrent periodontal pockets, every 30 days, until 3 months, when the periodontal parameters will be reassessed. **Name:** Periodontal treatment **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Plaque index will be expressed in percentage per individual to evaluate the supragingival plaque control. **Measure:** Plaque index (PI) **Time Frame:** Baseline and 3 months **Description:** Bleeding on probing (BOP) will be expressed in percentage per individual to evaluate presence of BOP \<20% good results. **Measure:** Bleeding on probing (BOP) **Time Frame:** Baseline and 3 months **Description:** Pocket probing depth (PPD) will be evaluated in millimeters. The measure will be performed at six sites per tooth using a periodontal probe. The PPD corresponds to the distance from the gingival margin to the apical portion of the gingival sulcus or periodontal pocket. **Measure:** Pocket probing depth (PPD) **Time Frame:** Baseline and 3 months **Description:** Gingival recession (GR) will be measured clinically in millimeters with a periodontal probe as the distance from the cemento-enamel junction to the depth of the free gingival margin. **Measure:** Gingival recession (GR) **Time Frame:** Baseline and 3 months **Description:** Clinical attachment level (CAL) will be measured clinically in millimeters with a periodontal probe and corresponds as the distance from the cemento-enamel junction to the base of the periodontal pocket. CAL represents the extension of periodontal support that has been lost around a tooth. **Measure:** Clinical attachment level (CAL) **Time Frame:** Baseline and 3 months #### Secondary Outcomes **Description:** Pooled biofilms from gingival fluid of four sites with PPD with 6 mm or more will be collected to evaluate the presence of periodontal pathogens. The samples will be collected from the selected sites and stored in eppendorfs with PBS 1X in -20oC until the microbiological analyses, that will consist in DNA extraction, electroforesis and qualitative polymerase chain reaction (PCR). **Measure:** Microbiogical analysis **Time Frame:** Baseline and 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult participants with periodontal disease; * Four or more periodontal sites with PPD≥6 mm and CAL≥5 mm, non-adjacent; * Generalized periodontitis, with more than 30% of the sites involved (Caton et al., 2018); * Stages III and IV of periodontal disease (Caton et al., 2018); Exclusion Criteria: * Participants with hypersensitivity to the components of the 0.005% methylene blue gel; * Received periodontal treatment in the last six months; * Drugs (alcoholics, use of anti-inflammatories and antibiotics in the last 3 months); Any evidence of systemic modifying factors which may directly interfere with the completion of the work (bias), such as: * Pregnant and breastfeeding women; * Hormone replacement therapy; * Smoking; * Hyperglycemia; * Osteoporosis; * Diagnosed with HIV+ or AIDS. **Healthy Volunteers:** True **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:** Gabriela AC Camargo, PhD **Phone:** 12981815874 **Phone Ext:** 55 **Role:** CONTACT #### Locations **Location 1:** **City:** Nova Friburgo **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Gabriela AC Camargo, PhD - **Phone:** 12981815874 - **Phone Ext:** 55 - **Role:** CONTACT **Country:** Brazil **Facility:** Fluminense Federal University **State:** Rio De Janeiro **Status:** RECRUITING **Zip:** 28625650 #### Overall Officials **Official 1:** **Affiliation:** Fluminense Federal University **Name:** Gabriela AC Camargo, Doctor **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** The result will be communicated verbally to each participant. **IPD Sharing:** NO ### References Module #### References **Citation:** Akram Z, Al-Shareef SA, Daood U, Asiri FY, Shah AH, AlQahtani MA, Vohra F, Javed F. Bactericidal Efficacy of Photodynamic Therapy Against Periodontal Pathogens in Periodontal Disease: A Systematic Review. Photomed Laser Surg. 2016 Apr;34(4):137-49. doi: 10.1089/pho.2015.4076. Epub 2016 Mar 16. **PMID:** 26982216 **Citation:** Akram Z. How effective is adjunctive antimicrobial photodynamic therapy in treating deep periodontal pockets in periodontal disease? A systematic review. J Investig Clin Dent. 2018 Nov;9(4):e12345. doi: 10.1111/jicd.12345. Epub 2018 Jun 4. **PMID:** 29863310 **Citation:** Ren C, McGrath C, Jin L, Zhang C, Yang Y. The effectiveness of low-level laser therapy as an adjunct to non-surgical periodontal treatment: a meta-analysis. J Periodontal Res. 2017 Feb;52(1):8-20. doi: 10.1111/jre.12361. Epub 2016 Mar 2. **PMID:** 26932392 ## Derived Section ### Condition Browse Module - Ancestors - 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: M13423 - Name: Periodontal Pocket - Relevance: LOW - As Found: Unknown - ID: M13419 - Name: Periodontal Diseases - Relevance: HIGH - As Found: Periodontal Diseases - ID: M28044 - Name: Chronic Periodontitis - Relevance: HIGH - As Found: Periodontitis, Adult - 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: D000010510 - Term: Periodontal Diseases - ID: D000055113 - Term: Chronic Periodontitis ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M11726 - Name: Methylene Blue - Relevance: LOW - As Found: Unknown - ID: M4854 - Name: Benzocaine - Relevance: LOW - As Found: Unknown - ID: T433 - Name: Tannic Acid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426537 **Brief Title:** Colchicine's Efficacy in MI Patients: Comparing PCI and Non-Reperfusion Approaches **Official Title:** A Comparative Study of Colchicine's Role in Reducing Cardiac Fibrosis in Acute Myocardial Infarction Patients: Evaluating Outcomes With Percutaneous Coronary Intervention Versus Without Reperfusion #### Organization Study ID Info **ID:** 400/235/K.3/302/2020 #### Organization **Class:** OTHER **Full Name:** University of Brawijaya ### Status Module #### Completion Date **Date:** 2023-11-20 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-03-25 **Type:** ACTUAL #### Start Date **Date:** 2022-10-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Brawijaya #### Responsible Party **Investigator Affiliation:** University of Brawijaya **Investigator Full Name:** Tri Astiawati **Investigator Title:** Dr. Iskak General Hospital, Tulungagung, East Java, Indonesia **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:** This study investigates the effect of Colchicine in preventing heart structure changes following ST-segment elevation myocardial infarction. Through a clinical trial involving patients requiring coronary intervention, we explore how Colchicine can reduce inflammation and fibrosis, two crucial factors influencing heart failure post-heart attack. The outcomes are expected to offer new insights into post-heart attack treatments to prevent heart failure. **Detailed Description:** This clinical trial, a prospective, focuses on patients with ST-Elevation Myocardial Infarction (STEMI) requiring Percutaneous Coronary Intervention (PCI) within 12 hours of onset. The study aims to control bias effectively through randomization, evenly distributing confounding factors across two groups. Patients, unknown to both researchers and themselves whether receiving Colchicine or a placebo, will undergo reperfusion therapy and optimal medicinal treatment according to the latest guidelines. The study population includes all STEMI patients in three cities in East Java (Jember, Malang, Tulungagung), selected through purposive sampling. The independent variable is Colchicine administration, while dependent variables include ventricular remodeling assessed by Left Ventricular End-Diastolic Volume (LVEDV) via echocardiography, serum levels of caspase-1, TGF-β, NT pro BNP and Galectin-3. All patients receive standard medical treatment pre-PCI, including aspirin and antiplatelet drugs, with post-PCI Optical Medical Treatment (OMT) following the latest guidelines. The trial is randomized, double-blinded, and placebo-controlled, with participants divided into four groups: early PCI with Colchicine or placebo, and STEMI without reperfusion, receiving either Colchicine or placebo. This setup allows for a comprehensive comparison across different patient management strategies, exploring Colchicine's potential benefits in post-AMI care and its effects on key inflammatory and fibrotic markers. ### Conditions Module **Conditions:** - ST-Elevation Myocardial Infarction ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This study investigates the impact of Colchicine on patients with ST-Elevation Myocardial Infarction (STEMI) undergoing different treatment strategies, including percutaneous coronary intervention (PCI) and no revascularization. ##### Masking Info **Masking:** SINGLE **Masking Description:** The subjects of this study are patients with ST-Elevation Myocardial Infarction (STEMI) who have undergone Percutaneous Coronary Intervention (PCI) and those without reperfusion. Subject selection was conducted using purposive sampling. Patients who received early PCI without reperfusion were divided into four groups: 1). Early PCI with Colchicine, 2). Early PCI with placebo, 3). STEMI without reperfusion with Colchicine and STEMI without reperfusion with placebo. This approach aims to rigorously evaluate the effects of Colchicine in managing inflammation and cardiac remodeling in STEMI patients, comparing its efficacy against standard placebo treatment. **Who Masked:** - PARTICIPANT **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 63 **Type:** ACTUAL **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients receive colchicine according to protocol: Loading dose of 1 mg 1-2 hours before PCI, 0.5 mg colchicine 1 hour after loading, Maintenance dose of 1 x 0.5 mg colchicine for 1 month and OMT **Intervention Names:** - Drug: Colchicine 0.5 MG Oral Tablet **Label:** Colchicine Intervention in STEMI Patients Onset < 12 Hours Undergoing PCI **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Patients receive placebo according to protocol: Placebo administration and OMT **Intervention Names:** - Drug: Colchicine 0.5 MG Oral Tablet **Label:** Placebo in STEMI Patients Onset < 12 Hours Undergoing PCI **Type:** PLACEBO_COMPARATOR #### Arm Group 3 **Description:** Patients receive colchicine according to protocol: Loading dose of 1 mg, 0.5 mg colchicine 1 hour after loading, Maintenance dose of 1 x 0.5 mg colchicine for 1 month and OMT **Intervention Names:** - Drug: Colchicine 0.5 MG Oral Tablet **Label:** Colchicine Intervention in STEMI Patients Onset < 12 Hours Not Undergoing Reperfusion **Type:** ACTIVE_COMPARATOR #### Arm Group 4 **Description:** Patients receive placebo according to protocol: Placebo administration and OMT **Intervention Names:** - Drug: Colchicine 0.5 MG Oral Tablet **Label:** Placebo in STEMI Patients Onset < 12 Hours Not Undergoing Reperfusion **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Colchicine Intervention in STEMI Patients Onset < 12 Hours Not Undergoing Reperfusion - Colchicine Intervention in STEMI Patients Onset < 12 Hours Undergoing PCI - Placebo in STEMI Patients Onset < 12 Hours Not Undergoing Reperfusion - Placebo in STEMI Patients Onset < 12 Hours Undergoing PCI **Description:** Oral administration of Colchicine in STEMI patients **Name:** Colchicine 0.5 MG Oral Tablet **Other Names:** - Colchicine Tablets - Generic Colchicine - Colchicine Oral Administration **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** This study assesses the impact of colchicine on ventricular remodeling by measuring changes in the expression of NLRP3 inflammasome, TGF-β, and galectin-3. These biomarkers are indicative of inflammation and fibrotic activity affecting ventricular structure and function in acute STEMI patients post-PCI or without reperfusion therapy **Measure:** mpact of Colchicine on Ventricular Remodeling in Acute ST-Elevation Myocardial Infarction (STEMI) Patients Post-PCI **Time Frame:** Baseline and 1 month post-intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Men and women aged 18 years or older. Able and willing to provide informed consent. Presenting with clinical symptoms and supporting examinations indicative of a first-time diagnosis of IMA-EST. Eligible for treatment according to the IMA-STEMI guidelines, which may include: Antiplatelet therapy Renin-angiotensin-aldosterone system inhibitors Beta-blockers Specifically, includes patients who have: Undergone early PCI. Not received reperfusion therapy. Female patients must commit to avoiding pregnancy during the study. Willing to participate in follow-up via face-to-face or telephone contact. Exclusion Criteria: Presence of concurrent diseases such as infections, inflammation, or malignancy. Diagnosed with gastrointestinal disorders including Crohn's disease, ulcerative colitis, or exhibiting chronic diarrhea. Recent abnormal laboratory results (within the last 30 days) including: Hemoglobin below 11.5 g/L Leukocytes below 3.0 x 10\^9/L Platelets below 110 x 10\^9/L ALT more than three times the upper limit of normal Total bilirubin more than twice the upper limit of normal Creatinine more than twice the upper limit of normal History of liver cirrhosis, acute hepatitis exacerbation, or severe liver disease. Currently pregnant, breastfeeding, or planning to become pregnant during the study. History of alcohol abuse. Receiving long-term steroid therapy or using colchicine for other indications. History of hypersensitivity to colchicine. Severe renal failure (eGFR below 30). History of cardiac arrest, ventricular fibrillation, cardiogenic shock, or hemodynamic instability. Unwilling or unable to provide informed consent. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Tulung Agung **Country:** Indonesia **Facility:** Tri Astiawati **State:** East Java **Zip:** 66223 #### Overall Officials **Official 1:** **Affiliation:** Dr. Iskak General Hospital, Tulungagung, East Java, Indonesia **Name:** Tri Astiawati, MD. SpJp **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** we will distribute the informed consent form and the study protocol **IPD Sharing:** NO ### References Module #### Available IPDs **Type:** Study Protocol **URL:** http://drive.google.com/drive/u/3/folders/15qW39gHRtgwIuP8rGm8ukhXtYnLRCFNO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007511 - Term: Ischemia - ID: D000010335 - Term: Pathologic Processes - ID: D000009336 - Term: Necrosis - 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: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12155 - Name: Myocardial Infarction - Relevance: HIGH - As Found: Myocardial Infarction - ID: M10282 - Name: Infarction - Relevance: HIGH - As Found: Infarction - ID: M8485 - Name: Fibrosis - Relevance: LOW - As Found: Unknown - ID: M1072 - Name: ST Elevation Myocardial Infarction - Relevance: HIGH - As Found: ST Elevation Myocardial Infarction - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M12284 - Name: Necrosis - 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: D000009203 - Term: Myocardial Infarction - ID: D000072657 - Term: ST Elevation Myocardial Infarction - ID: D000007238 - Term: Infarction ### Intervention Browse Module - Ancestors - ID: D000006074 - Term: Gout Suppressants - ID: D000018501 - Term: Antirheumatic Agents - 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: ARhu - Name: Antirheumatic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M6307 - Name: Colchicine - Relevance: HIGH - As Found: Observed - ID: M20604 - Name: Antirheumatic Agents - 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: D000003078 - Term: Colchicine ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426524 **Brief Title:** Efficacy of Insulin Like Growth Factor-1(IGF-1) on Bone Regeneration in Intrabony Defects : A Clinico-radiograph Study **Official Title:** Efficacy of Insulin Like Growth Factor-1(IGF-1) on Bone Regeneration in Intrabony Defects : A Clinico-radiograph Study #### Organization Study ID Info **ID:** SVSInstituteDS1 #### Organization **Class:** OTHER **Full Name:** SVS Institute of Dental Sciences ### Status Module #### Completion Date **Date:** 2024-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05 **Type:** ESTIMATED #### Start Date **Date:** 2023-05-19 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Dr R Viswa Chandra #### Responsible Party **Investigator Affiliation:** SVS Institute of Dental Sciences **Investigator Full Name:** Dr R Viswa Chandra **Investigator Title:** PROFFESSOR AND HEAD OF THE DEPARTMENT **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The aim of this study is to clinically evaluate the efficacy of Insulin like Growth Factor (IGF-1) on bone regeneration in intrabony defects. **Detailed Description:** In test group, after reflection of flap and degranulation, IGF-1 gel with hydroxyapatite will be placed in the defect and sutures will be placed. In control group, after reflection of flap and degranulation, hydroxyapatite will be placed in the defect and sutures will be placed. ### Conditions Module **Conditions:** - Intrabony Periodontal Defect ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 24 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In test group, after reflection of flap and degranulation, IGF-1 gel with hydroxyapatite will be placed in the defect and sutures will be placed. **Intervention Names:** - Procedure: IGF-1 Gel **Label:** Test group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** In control group, after reflection of flap and degranulation, hydroxyapatite will be placed in the defect and sutures will be placed. **Intervention Names:** - Procedure: Hydroxyapatite **Label:** Control group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Test group **Description:** After degranulation of the defect, IGF-1 gel mixed with Hydroxyapatite graft will be placed in the defect. **Name:** IGF-1 Gel **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Control group **Description:** After degranulation of the defect, Hydroxyapatite graft will be placed in the defect. **Name:** Hydroxyapatite **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Radiovisiography (RVG) will be used to assess bone regeneration achieved post operatively after 3 months and 6 months. **Measure:** Bone Regeneration **Time Frame:** 3 months and 6 months **Description:** Assessment of clinical attachment level using UNC-15 probe at baseline and post operatively at 3 and 6 months. **Measure:** clinical attachment level **Time Frame:** 3 months and 6 months **Description:** Assessment of probing depth using UNC-15 probe at baseline and postoperatively at 3 and 6 months. **Measure:** Probig depth **Time Frame:** 3 months and 6 months #### Secondary Outcomes **Description:** Assessment of plaque (PI) - according to Turesky modification of Quigley and Hein Plaque Index, 1970. **Measure:** Plaque Index **Time Frame:** 3 months and 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Systemically healthy male and female patients of age \>18 years Intrabony defects - two wall or three wall defects Probing pocket depths (PPD) of \>5mm. Exclusion Criteria: Medically compromised patients Pregnant women Heavy smokers Patients who underwent radiotherapy or chemotherapy are excluded **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:** Dr R Viswa Chandra, MDS;DNB;PhD **Phone:** 8179367147 **Role:** CONTACT #### Locations **Location 1:** **City:** Hyderabad **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Rampalli Viswa Chandra, MDS; DNB - **Phone:** 9908183071 - **Role:** CONTACT **Country:** India **Facility:** SVS Institute of Dental Sciences, Mahabubnagar **State:** Telangana **Status:** RECRUITING **Zip:** 509002 ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M10365 - Name: Insulin - Relevance: LOW - As Found: Unknown - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: LOW - As Found: Unknown - ID: M11900 - Name: Mitogens - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426511 **Acronym:** CONTINUE **Brief Title:** ctDNA-MRD Guided Consolidation Toripalimab in Stage IB-IIIA NSCLC **Official Title:** Consolidation Toripalimab Therapy Guided by Circulating Tumor DNA (ctDNA)-Minimal Residual Disease (MRD) for Completely Resected Stage IB-IIIA Non-small-cell Lung Cancer (Without EGFR or ALK Alterations for Nonsquamous Lung Cancer) #### Organization Study ID Info **ID:** GASTO10112 #### Organization **Class:** OTHER **Full Name:** Sun Yat-sen University ### Status Module #### Completion Date **Date:** 2029-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Sun Yat-sen University #### Responsible Party **Investigator Affiliation:** Sun Yat-sen University **Investigator Full Name:** Si-Yu Wang **Investigator Title:** Professor **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 aims to incorporate circulating tumor DNA (ctDNA)-minimal residual disease (MRD) to personalize the administration of consolidation toripalimab therapy in resected stage IB-IIIA non-small-cell lung cancer (NSCLC) after adjuvant therapy. Toripalimab is a humanized monoclonal antibody for human programmed cell death protein 1. Toripalimab was approved as a consolidation treatment after perioperative therapy in combination with chemotherapy for resectable stage III NSCLC. **Detailed Description:** Most patients with stage IB-IIIA non-small cell lung cancer (NSCLC) are managed with surgery, follow by standard-of-care adjuvant platinum-based chemotherapy. However, postoperative recurrence rates remain high. Recent years, the role of checkpoint inhibitors has been proven to be effective in patients with advanced NSCLC, and even in patients with resectable NSCLC. Emerging data supports the use of consolidation checkpoint inhibitors therapy in localized NSCLC. Based on the results from Neotorch trial, consolidation toripalimab therapy led to a significant improvement in event-free survival for patients with resectable NSCLC. However, not all patients may benefit from consolidation therapy. Circulating tumor DNA (ctDNA) has emerged as a promising biomarker for early detection of minimal residual disease (MRD) in cancer surveillance. There is a critical need to identify MRD after curative therapies to determine which patients may benefit from consolidation toripalimab therapy. The aim of this study is to explore whether observation follow-up for patients with negative ctDNA after adjuvant therapy has a non-inferior prognosis for patients with positive ctDNA and received consolidation toripalimab therapy. This study aims to incorporate ctDNA-MRD to personalize the administration of consolidation toripalimab therapy for completely resected stage IB-IIIA NSCLC (without EGFR or ALK alterations for nonsquamous NSCLC). ### Conditions Module **Conditions:** - Lung Cancer, Nonsmall Cell ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Incorporate ctDNA-MRD to personalize the administration of consolidation toripalimab therapy for completely resected stage IB-IIIA NSCLC ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Observation follow-up for patients with undetectable ctDNA after 4 cycles of adjuvant chemotherapy plus toripalimab. **Intervention Names:** - Drug: Toripalimab+Chemotherapy **Label:** Observation for undetectable ctDNA after adjuvant therapy **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Consolidation toripalimab therapy for up to 13 cycles for patients with detectable ctDNA after 4 cycles of adjuvant chemotherapy plus toripalimab. **Intervention Names:** - Drug: Toripalimab+Chemotherapy followed by consolidation toripalimab **Label:** Consolidation toripalimab for detectable ctDNA after adjuvant therapy **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Observation for undetectable ctDNA after adjuvant therapy **Description:** After surgical resection, patients received 4 cycle of toripalimab (240 mg) in combination with platinum-based adjuvant treatment. Administration of standard postoperative adjuvant chemotherapy for stage IB disease was not mandatory; decisions about whether patients with IB disease would receive adjuvant chemotherapy were made by the physicians. **Name:** Toripalimab+Chemotherapy **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Consolidation toripalimab for detectable ctDNA after adjuvant therapy **Description:** After surgical resection, patients received 4 cycle of toripalimab (240 mg) in combination with platinum-based adjuvant treatment, and then maintenance treatment with single-agent toripalimab (240 mg) once every 3 weeks for up to 13 cycles. Administration of standard postoperative adjuvant chemotherapy for stage IB disease was not mandatory; decisions about whether patients with IB disease would receive adjuvant chemotherapy were made by the physicians. **Name:** Toripalimab+Chemotherapy followed by consolidation toripalimab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Determine if ctDNA-MRD guided consolidation toripalimab has a non-inferior 2-year DFS to direct 13 cycles of consolidation toripalimab therapy. 2-year DFS was defined as the proportion of patients who were disease free at 2 years. **Measure:** The 2-year DFS rate of ctDNA-MRD guided consolidation toripalimab **Time Frame:** Baseline to 24 months #### Secondary Outcomes **Description:** Determine if ctDNA-MRD guided consolidation toripalimab has a non-inferior 2-year OS to direct 13 cycles of consolidation toripalimab therapy. 2-year OS was defined as the proportion of patients who were alive at 2 years. **Measure:** The 2-year OS rate of ctDNA-MRD guided consolidation toripalimab **Time Frame:** Baseline to 24 months **Description:** Estimate the 2-year DFS in patients with persistently detectable ctDNA after receiving ≥6 months of consolidation toripalimab. **Measure:** The 2-year DFS in patients with persistently detectable ctDNA **Time Frame:** Baseline to 24 months **Description:** Percentage of patients with undetectable ctDNA after consolidation toripalimab of 13 cycles. **Measure:** Percentage of patients with undetectable ctDNA after consolidation toripalimab. **Time Frame:** Baseline to 15 months **Description:** Percentage of patients with detectable ctDNA after 4 cycles of adjuvant chemotherapy plus toripalimab. **Measure:** Percentage of patients with detectable ctDNA after adjuvant chemotherapy plus toripalimab. **Time Frame:** Baseline to 3 months **Description:** Adverse Events were monitored according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. **Measure:** Adverse Events **Time Frame:** Baseline to 36 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Subjects must have undergone complete surgical resection (R0) of their stage IB , II and select IIIA NSCLC according to the AJCC 8th edition staging; * Squamous or non-squamous NSCLC histology; * Subjects should be without EGFR or ALK alterations for nonsquamous NSCLC; * Male and female, aged 18-75 years; * Surgery for lung cancer must be completed ≤ 60 days prior to study treatment; * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; * Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level); * Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN; * Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min; * Female subjects should not be pregnant or breast-feeding; * Written informed consent provided. Being willing and able to comply with the visits, treatment plan, laboratory examinations and other study procedures scheduled in the study. Exclusion Criteria: * Not R0 resection, or metastatic disease. * Subjects with known EGFR sensitive mutations or ALK translocation, EGFR and ALK mutation status needs to be identified for the subjects with non-squamous NSCLC; * Previous treatment with systemic antitumor therapy for NSCLC; * Severe allergic reaction to other monoclonal antibodies; * Subjects with any known or suspected autoimmune disorder or immunodeficiency, with the following exceptions: hypothyroidism, hormone therapy is not needed, or well controlled at physiological dose; controlled type I diabetes; * Uncontrolled active hepatitis B (defined as positive hepatitis B surface antigen in screening period with HBV-DNA detected higher than the upper limit of normal at the clinical laboratory of the study center); active hepatitis C (defined as positive hepatitis C surface antibody in screening period and positive HCV-RNA); * Vaccination of live vaccine within 30 days prior to the first dose; * Evidence of clinically active interstitial lung disease; * Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS); * Inability to comply with protocol or study procedures; * Any unstable systemic disease (including active infection, active tuberculosis uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease); * A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study and may confuse the study results; * History of another malignancy in the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted. * Women who are pregnant or nursing. * Ingredients mixed with small cell lung cancer patients. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Si-Yu Wang, MD **Phone:** +86 20 87343439 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Sun Yat-sen University **Name:** Si-Yu Wang, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Info Types:** - STUDY_PROTOCOL - SAP **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Ancestors - 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 - ID: D000002283 - Term: Carcinoma, Bronchogenic - ID: D000001984 - Term: Bronchial Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - 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: M11172 - Name: Lung Neoplasms - Relevance: HIGH - As Found: Lung Cancer - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: HIGH - As Found: Lung Cancer, Nonsmall Cell - ID: M20497 - Name: Neoplasm, Residual - Relevance: LOW - As Found: Unknown - ID: M5534 - Name: Carcinoma - 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: D000002289 - Term: Carcinoma, Non-Small-Cell Lung ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426498 **Brief Title:** tFUS Induced Transient Scotoma for Individual Dosing **Official Title:** Developing a Method of Adjusting the Strength of Transcranial Focused Ultrasound (tFUS) to Personalize Treatment. #### Organization Study ID Info **ID:** Pro00132894 #### Organization **Class:** OTHER **Full Name:** Medical University of South Carolina ### Status Module #### Completion Date **Date:** 2025-08-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-06 **Type:** ESTIMATED **Last Update Submit Date:** 2024-06-04 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05-20 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-20 **Type:** ESTIMATED **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Medical University of South Carolina #### Responsible Party **Investigator Affiliation:** Medical University of South Carolina **Investigator Full Name:** Mark S. George **Investigator Title:** Professor-Faculty **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purposes of this research study is to: 1. Develop a technique of transcranial Focused Ultrasound Stimulation (tFUS) where meaningful effects on the brain can be easily measured. 2. Use this technique to measure threshold for effective tFUS in individuals. 3. Determine whether disruption of conscious visual detection, versus non-conscious visually-guided behavior have different thresholds for disruption with tFUS. **Detailed Description:** Transcranial focused ultrasound (tFUS) is a new noninvasive way to stimulate the brain in an awake and alert person. Investigators do not yet have an easily observable way to know whether they are in the right brain location with the correct dose for that person. Investigators wonder if they can produce a transient change in someone's visual field, called a scotoma, and whether they can use that to determine the minimum tFUS dose for that person. ### Conditions Module **Conditions:** - Healthy **Keywords:** - ulltrasound - tFUS - scotoma - visual field ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Masking Description:** The device will be on either right or left V1, and the ultrasound will be cycling on or off during the session. Subjects and investigators will be masked to on/off timing and puck location. **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All subjects will get tFUS, open label **Intervention Names:** - Device: Brainsonix Bx Pulsar machine tFUS **Label:** tFUS over V1 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - tFUS over V1 **Description:** This is a tFUS device, delivering ultrasound at a dose within the FDA safety guidelines. **Name:** Brainsonix Bx Pulsar machine tFUS **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Production of a temporary Scotoma as assessed by visual field testing of briefly presented objects in different quadrants while staring at a central cross on a computer screen. **Measure:** Temporary Scotoma **Time Frame:** During and immediately after (10 minutes) the tFUS ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or female * Age 18-70 * Normal or corrected-to normal vision and hearing * No neurological or psychological illness Exclusion Criteria: * Diagnosis of any depressive or anxiety disorder * Diagnosis of schizophrenia or bipolar disorder * Current use of any non-prescribed psychoactive medications or drugs * Contraindication to enter the MRI environment. * Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short term). * Urine Pregnancy Test: If the subject is a woman of childbearing potential and /or a man capable of fathering a child before, during, and/or after participation precaution should be taken. Examples of acceptable methods of birth control for participants involved in the study include: birth control pills, patch, IUD, condom, sponge, diaphragm with spermicide, or avoiding sexual activity that could cause the subject to become pregnant. * Inability to adhere to treatment schedule. * Initiation of new antidepressant treatment at the time of study randomization. NOTE: There will be no exclusion based upon gender or minority status. We anticipate that at least 50% of the participants will be women. The percentage of minority participants is expected to be at least 5%. We will make vigorous attempts to increase this number by posting advertisement flyers in minority communities. Children, prisoners, and institutionalized individuals will not be recruited, because they are beyond the scope of the objectives. Moreover, we will emphasize that participation in this study is completely voluntary. Recruitment of women and minorities has been addressed above. Non-English speaking subjects will not be recruited because they may not be able to understand instructions, which could undermine the validity of the results. **Healthy Volunteers:** True **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:** Bridgette Holland **Phone:** 843 638 7517 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Mark S George, MD **Phone:** 843 876 5142 **Role:** CONTACT #### Locations **Location 1:** **City:** Charleston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Mark S George, MD - **Phone:** 843-876-5142 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Baron E Short, MD - **Phone:** 843 876 5142 - **Role:** CONTACT **Country:** United States **Facility:** Medical University of South Carolina Brain Stimulation Division **State:** South Carolina **Status:** RECRUITING **Zip:** 29425 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014786 - Term: Vision Disorders - ID: D000012678 - Term: Sensation Disorders - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC11 - Name: Eye Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M15424 - Name: Scotoma - Relevance: HIGH - As Found: Scotoma - 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: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012607 - Term: Scotoma ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426485 **Brief Title:** To Evaluate the Long-term Efficacy and Safety of Toludevenlafaxine Hydrochloride Sustained-release Tablets **Official Title:** A Multicenter, Randomized Withdrawal, Double-blind, Parallel, Placebo-controlled Design Clinical Trial of Toludesvenlafaxine Hydrochloride Extended-Release Tablets #### Organization Study ID Info **ID:** LY03005/CT-CHN-408 #### Organization **Class:** INDUSTRY **Full Name:** Luye Pharma Group Ltd. ### Status Module #### Completion Date **Date:** 2027-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-02-28 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-04-24 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Luye Pharma Group 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 is a multicenter, randomized withdrawal, double-blind, parallel, placebo-controlled design clinical trial of Toludesvenlafaxine Hydrochloride Extended-Release Tablets to evaluate the long-term efficacy and safety in the treatment of Chinese patients with depression. ### Conditions Module **Conditions:** - Major Depressive Disorder ### 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:** 736 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** orally once a day **Intervention Names:** - Drug: Toludesvenlafaxine Hydrochloride Sustained-release Tablets **Label:** Toludesvenlafaxine Hydrochloride Sustained-release Tablets 80 mg or 160 mg group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** orally once a day **Intervention Names:** - Drug: placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Toludesvenlafaxine Hydrochloride Sustained-release Tablets 80 mg or 160 mg group **Description:** orally once a day **Name:** Toludesvenlafaxine Hydrochloride Sustained-release Tablets **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** orally once a day **Name:** placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Time to relapse. **Time Frame:** from Baseline to week 24 #### Secondary Outcomes **Measure:** Change From Double-Blind Treatment Period Baseline in Montgomery - Eisberg Depression Rating Scale (MADRS) Total Score; **Time Frame:** from Baseline to week 24 **Measure:** Change from Double-Blind Treatment Period Baseline in Clinical Global Impression Scale - Severity of Illness (CGI-S) score and Clinical Global Impression Scale - Global Improvement (CGI-I) score **Time Frame:** from Baseline to week 24 **Measure:** Change From Double-Blind Treatment Period Baseline in Hamilton Anxiety Rating Scale (HAMA) Total Score. **Time Frame:** from Baseline to week 24 **Measure:** Change From Double-Blind Treatment Period Baseline in the Anhedonia Rating Scale (DARS) Score **Time Frame:** from Baseline to week 24 **Measure:** Change From Double-Blind Treatment Period Baseline in SHEEHAN Disability Scale (SDS) Score **Time Frame:** from Baseline to week 24 **Measure:** Change from Double-Blind Treatment Period Baseline in Digit Symbol Substitution Test (DSST) Score **Time Frame:** from Baseline to week 24] ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. The subject voluntarily signs the informed consent form and is able to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures; 2. Aged 18 years and above, male or female; 3. Outpatients with the main diagnosis of depression meeting DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) diagnostic criteria for recurrent episodes (without psychotic features) (F33.1/F33.2); 4. MADRS total score ≥ 26 at baseline of screening and open treatment phase. Exclusion Criteria: 1. Patients who meet the criteria of treatment-resistant depression, that is, patients who have failed to respond to at least two antidepressants with different mechanisms of action in the case of adequate treatment (at least 8 weeks of treatment at the maximum recommended therapeutic dose); 2. Known to have a history of allergy to any component of the investigational product or similar drugs, or allergic constitution (allergic to two or more drugs or food) and the investigator considers it inappropriate to participate in the trial; 3. Significant suicide attempt (defined as a score of ≥ 4 on item 10 of the MADRS scale) or suicidal behavior in the past 6 months on the Columbia-Suicide Severity Rating Scale (C-SSRS) ("actual attempt","interrupted attempt", and"abandoned attempt"with any outcome of"yes"); 4. Other diseases meeting DSM-5 diagnostic criteria, including organic mental disorders, substance-related and addictive disorders (except nicotine or caffeine), schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, substance/drug-induced depressive disorders, depressive disorders due to other physical/mental diseases, obsessive-compulsive and related disorders, traumatic and stress-related disorders, dissociative disorders, anorexia nervosa or bulimia, personality disorders; 5. Previous history of increased intraocular pressure or closed glaucoma; 6. Patients with poorly controlled hypertension \[screening or baseline sitting systolic blood pressure (SBP) ≥ 160 mmHg or sitting diastolic blood pressure (DBP) ≥ 100 mmHg\]; 7. Total bilirubin (TBIL) value 1.5 times higher than the upper limit of normal, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 3 times higher than the upper limit of normal, or creatinine 1.5 times higher than the upper limit of normal at screening; 8. Female patients who are pregnant or have a positive pregnancy test result, or male and female subjects of childbearing potential do not agree to use effective contraception throughout the study and for at least 1 month after discontinuation; 9. Patients who received electroconvulsive therapy (ECT) within 3 months before screening or currently require ECT according to the investigator's judgment; 10. Patients who have received or are receiving systemic psychotherapy (interpersonal therapy, dynamic therapy, cognitive behavioral therapy) within 3 months before screening or currently need systemic psychotherapy according to the investigator's judgment; 11. Patients who received physical therapy such as transcranial magnetic stimulation (TMS), deep brain stimulation, vagus nerve stimulation and transcranial electrical stimulation within 3 months before screening; 12. Patients who received phototherapy within 2 weeks before screening; 13. Patients who have stopped antidepressant drugs for less than 5 half-lives (at least 2 weeks for monoamine oxidase inhibitors (MAOIs) and 1 month for fluoxetine) before enrollment; 14. Those who have participated in other clinical trials within 1 month before screening (excluding those who are not eligible after screening and not enrolled); 15. Currently suffering from acute or severe unstable physical illness, or other conditions that the investigator judges the subject is not suitable for the study. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Hongyan Zhang **Phone:** 13601237138 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## 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: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depressive Disorder - ID: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M7060 - Name: Depressive Disorder, Major - Relevance: HIGH - As Found: Major Depressive Disorder - 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 - ID: D000003865 - Term: Depressive Disorder, Major ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426472 **Brief Title:** An Intervention on Psychosocial Health in Women With Unsuccessful IVF Experience **Official Title:** The Effect of Web-Based Support Program on Psychosocial Health Status in Women With Unsuccessful IVF Experience #### Organization Study ID Info **ID:** EBIstanbulUC #### Organization **Class:** OTHER **Full Name:** Istanbul University - Cerrahpasa (IUC) #### Secondary ID Infos **Domain:** TUBITAK **ID:** 1649B032306898 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2025-08-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Istanbul University - Cerrahpasa (IUC) #### Responsible Party **Investigator Affiliation:** Istanbul University - Cerrahpasa (IUC) **Investigator Full Name:** Elif Balkan **Investigator Title:** PhD Student **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this interventional study is to learn if web-based support program can improve the psychosocial health status in women with unsuccessful IVF experience. The main questions it aims to answer are: Does web-based support decrease the depressive symptoms, anxiety and infertility-related stress? Does web-based support decrease the hopelessness? Does web-based support increase the coping skills with infertility-related stress? Researchers will compare this intervention to a control group to see if web-based support program improves psychosocial health. Participants will: Use the web-based support intervention for 5 weeks or have no intervention. Complete the surveys on the website before and after the intervention. ### Conditions Module **Conditions:** - Infertility - Failed in Vitro Fertilisation **Keywords:** - infertility - web-based - support - psychosocial health ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Interventional group which will be given the web-based fertility support **Intervention Names:** - Other: Web-based support program **Label:** Intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Control group will not be given any intervention **Label:** Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention **Description:** Web-based support program for infertile women with failed IVF experience **Name:** Web-based support program **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Beck Depression Inventory (BDI) will be used to evaluate the participants' anxiety outcome. This inventory, whose validity and reliability in Turkish was studied by Hisli (1989), consists of a total of 21 items and four interpreted sub-dimensions. The scoring of the scale is a four-point Likert type (0 = positive statements about depression; 3 = negative statements about depression). The total score that can be obtained from the scale varies between 0-63; 0-9 points indicate minimal depression, 10-16 points indicate mild depression, 17-29 points indicate moderate depression, and 30-63 points indicate severe depression. **Measure:** Depression (Beck Depression Inventory) **Time Frame:** 24 months **Description:** The Infertility Stress Scale will be used to assess participants' infertility-related stress. Schmidt (2006) developed this scale in 1996. In our country, the validity and reliability of the scale was studied by Şahin Yılmaz (2012). This scale is a scale with a total of 14 items consisting of three sub-dimensions and answers are given in a Lykert type. Calculations per subdimensions requires a special formula for each subdimension. An increase in score is interpreted as an increase in stress. **Measure:** Infertility-related stress (The Infertility Stress Scale) **Time Frame:** 24 months **Description:** Coping with Infertility Stress Scale: Developed by Schmidt (2006) in 1996. In our country, the validity and reliability of the scale was studied by Şahin Yılmaz (2012). This scale is a scale with a total of 19 items consisting of four sub-dimensions. e Active-Struggle Coping, Passive-Struggle Coping, Passive-Ignoring Coping and Meaning-Based Coping Method. Each subscale score can be calculated seperately. **Measure:** Coping Skills with Infertility Stress (Coping with Infertility Stress Scale) **Time Frame:** 24 months #### Secondary Outcomes **Description:** Beck Hopelessness Scale: Beck et al. (1974) to measure the individual's negative expectations for the future. Although the Turkish adaptation of this scale was made by Seber (1993), Durak (1994) examined the validity, reliability and factor structure of the scale in more detail. The scale consists of a total of 20 questions and the answers are given as true/false. The scale consists of three subscales: feelings about the future, loss of motivation, and expectations about the future. 1 point for incorrect answers to items 1-3-5-6-8-10-13-15 and 19, and 1 point for correct answers to items 2-4-7-9-11-14-16-17-18 and 20. and a total score between 0 and 20 can be obtained from the scale. The "arithmetic sum" found by calculation is accepted as the "despair score". The scale does not have a cut-off score; as the scores obtained from the scale increase, it is interpreted that the individual's level of hopelessness also increases. **Measure:** Hopelessness **Time Frame:** 24 months **Description:** Web-Based Psychosocial Support Evaluation Form: It is an 8-question form created by researchers to evaluate opinions about the psychosocial support initiative applied to the web-based support program. System Usability Scale: The Turkish validity and reliability of the scale developed by Brooke (1996) was tested by Demirkol and Şeneler (2018). "The scale consisting of ten items is a five-point Likert type (1=Strongly Disagree, 2=Disagree, 3=Undecided, 4=Agree, 5=Strongly Agree)." Items numbered 1, 3, 5, 7, 9 in the scale are scored positively, and items numbered 2, 4, 6, 8, 10 are reverse scored because they contain negative expressions. The answer "I strongly disagree" is calculated as "0" and the answer "I strongly agree" is calculated as 4 points. To obtain the total score, the score from each item is multiplied by 2.5 to obtain a score ranging from 0 to 100. A score between 65-70 is sufficient to show that the website is usable. **Measure:** Effect of the Web-based study program **Time Frame:** 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Having at least three repeated unsuccessful IVF experiences, 2. Maximum one month has passed since the negative IVF experience, 3. Participating in the study voluntarily, 4. Being able to read, understand and communicate in Turkish. Exclusion criteria 1. Not having access to the internet/not knowing how to use it, 2. Having any psychiatric disease/being in the 'severe depression' grade as a result of the Beck Depression Inventory, 3. Having at least one living child. Exclusion criteria from the study in the stages after including the study: 1. Spontaneous pregnancy occurring, 2. Starting a new treatment cycle, 3. Not continuing to monitor the modules on the website. **Gender Based:** True **Healthy Volunteers:** True **Minimum Age:** 21 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Elif Balkan, PhD Student **Phone:** +90 5423513125 **Role:** CONTACT ## 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: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426459 **Brief Title:** Social Media Usage in Adolescent Girls **Official Title:** Positive and Negative Effects of Social Media Usage in Adolescent Girls #### Organization Study ID Info **ID:** IRTG_P09 #### Organization **Class:** OTHER **Full Name:** International Research Training Group 2804 ### Status Module #### Completion Date **Date:** 2026-03-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-29 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-04-14 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** German Research Foundation **Class:** OTHER **Name:** University Hospital Tuebingen **Class:** OTHER **Name:** Uppsala University #### Lead Sponsor **Class:** OTHER **Name:** International Research Training Group 2804 #### 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 explore the effects of hormonal fluctuations throughout the menstrual cycle on social media use, brain architecture, neural reward processing and reward behavior, and affective status in adolescent girls. Additionally, it strives to compare the effects of exogenous and endogenous hormones on the above-mentioned aspects. For this purpose, the investigators will compare two main groups in the study: 1. Naturally cycling adolescent girls, 2. Adolescent girls using combined oral contraceptives. This study will combine self-report data via questionnaires, ecological data via Ecological Momentary Assessment (EMA), endocrine data via blood collection, and neural data via fMRI assessment to enhance the understanding of the neurobiological mechanisms underlying social media use in adolescent girls. Furthermore, it seeks to elucidate whether there are vulnerable periods throughout the menstrual cycle when adolescent girls are especially prone to dysfunctional social media use and help to design more specific interventions as well as therapy. **Detailed Description:** For each participant, there is a screening session, a month-long EMA assessment and two experimental fMRI sessions are planned. After making sure the participants fill the inclusion and exclusion criteria, the investigators will invite them to the laboratory for a screening session (T0). In this session, the participants will provide written informed consent and assent in case of those under 18 years old and written, informed consent for those who are 18 year old. Furthermore, the participants will participate in a standardized clinical interview to screen for mental disorders (Kinder-DIPS). Subsequently, they will be informed about the study details. Finally, they will fill out questionnaires about personality, depressive symptoms, anxiety symptoms, gender identity and norms, mood, loneliness, social media disorder, internet use, social support, and fear of missing out. Naturally cycling adolescent girls will join the two fMRI measurements (T1 \& T2) during the follicular and luteal phase of the menstrual cycle. Adolescent girls using combined oral contraceptives will join the first fMRI measurement during the pill intake period, and the second measurement during the break period. The fMRI sessions will comprise of filling out questionnaires, fMRI measurements, and blood collection for hormonal assessment. Questionnaires on depressive symptoms, state anxiety, mood, gender identity, self-esteem, loneliness, fear of missing out (FOMO), social media disorder, internet use, social support and social media use will be administered through RedCap platform. This will ensure the assessment of subjective, self-report data and its changes throughout the measurement time of one month. The sequence of fMRI measurements incudes four main parts, namely anatomical scan, resting-state scan, Effort Allocation Task (EAT), and diffusion tensor imaging (DTI). This protocol ensures the acquisition of the structural and functional data of the brain in the participants. The detailed protocol components are as follows: 1. Anatomical scan: This first sequence of the protocol ensures assessment and insight into the anatomy of the brain, thus providing structural data of the participants' brain. This will last approximately 8 minutes. 2. Resting-state scan: The next sequence involves participants watching a movie that was designed to improve imaging at rest for approximately 10 minutes. This sequence ensures insight into brain activity when no task is being performed and when the participant is at rest. 3. Effort Allocation Task (EAT): This next sequence aims to assess reward processing and reward behavior in the participants. During this task, participants have to exert physical effort on a grip force device when faced with monetary points at stake. There are two types of reward a participant can face; low and high reward. Additionally, there are two difficulty levels during the task, one being easier and the other more difficult. The payoff for the invested effort will be proportional to its duration. The task will last approximately 17 minutes. 4. Diffusion Tensor Imaging (DTI): During the final sequence, participants will undergo DTI assessment to ensure insight into white matter microstructure and connectivity. This will last approximately 7-8 minutes. To thoroughly investigate the participants' experiences in their natural environments, Ecological Momentary Assessment (EMA) will be conducted. This will be done through an app called m-Path where participants will fill out daily questionnaires about social media use, self-esteem, premenstrual symptoms, and mood throughout one month. A daily questionnaire lasts approximately 10 minutes. This assessment will ensure data about subjective experiences with high ecological validity. ### Conditions Module **Conditions:** - Menstrual Cycle - Oral Contraceptive **Keywords:** - Social media use - Adolescent girls - Menstrual cycle - Oral contraceptive - Neuroimaging - Women's mental health ### Design Module #### Bio Spec **Description:** Blood collection for hormonal assessment **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** OTHER #### Enrollment Info **Count:** 70 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Adolescent girls who have a natural menstrual cycle and have not used any kind of hormonal contraception for at least 6 months. **Label:** Natural menstrual cycle #### Arm Group 2 **Description:** Adolescent girls who use combined oral contraceptives for at least 4 months. **Label:** Oral contraceptive ### Outcomes Module #### Primary Outcomes **Description:** Possible differences between naturally cycling adolescent girls and those taking combined oral contraceptives in brain structure **Measure:** Brain disparities: Contrasting naturally cycling adolescent girls with those using combined oral contraceptives **Time Frame:** Measured twice appr. 2-3 weeks apart; approximately 45 minutes each time **Description:** Possible differences between naturally cycling adolescent girls and those taking combined oral contraceptives in brain function (functional activation based on BOLD effect) **Measure:** Brain disparities: Contrasting naturally cycling adolescent girls with those using combined oral contraceptives **Time Frame:** Measured twice appr. 2-3 weeks apart; approximately 45 minutes each time] **Description:** Possible differences between naturally cycling adolescent girls and those taking combined oral contraceptives on reward processing **Measure:** Reward-processing disparities: Contrasting naturally cycling adolescent girls with those using combined oral contraceptives **Time Frame:** Measured twice appr. 2-3 weeks apart; approx. 17 minutes each time **Description:** Possible differences in social media use between the two groups **Measure:** Social media use disparities: Contrasting naturally cycling adolescent girls and those using combined oral contraceptives **Time Frame:** Measured through ecological momentary assessment every day throughout one month #### Secondary Outcomes **Description:** Possible differences between the two phases of the menstrual cycle in social media use **Measure:** Social media use disparities: Contrasting follicular and luteal phase in naturally cycling adolescent girls **Time Frame:** Measured through ecological momentary assessment every day throughout one month **Description:** Possible differences in brain function and structure in naturally cycling girls in follicular vs. luteal phase **Measure:** Brain Disparities: Contrasting follicular and luteal phase in naturally cycling adolescent girls **Time Frame:** Measured twice appr. 2-3 weeks apart; circa 45 minutes each time **Description:** Possible differences in reward processing and reward behavior between the two menstrual cycle phases **Measure:** Reward-processing disparities: Contrasting follicular and luteal phase in naturally cycling adolescent girls **Time Frame:** Measured twice appr. 2-3 weeks apart; circa 45 minutes each time **Description:** Possible effects of personality type on brain structure and brain function for both groups. Personality measured by the NEO-Five-Factor-Inventory. **Measure:** Associations between personality and brain function & structure **Time Frame:** Measured twice appr. 2-3 weeks apart; circa 45 minutes each time **Description:** Possible effects of personality type on reward processing for both groups. Personality measured by the NEO-Five-Factor-Inventory. **Measure:** Associations between personality and reward processing & behavior **Time Frame:** Measured twice appr. 2-3 weeks apart; circa 17 minutes each time **Description:** Possible differences in self-esteem between the two phases of the menstrual cycle **Measure:** Self-esteem differences: Contrasting follicular and luteal phase in naturally cycling adolescent girls **Time Frame:** Measured through ecological momentary assessment every day throughout one month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Between 15 and 18 years old adolescent girls * Body mass index(18-25kg/m2) * Natural menstrual cycle (between 25 to 31 days) OR use of combined oral contraceptives for at least 4 months * Social media use (e.g., Instagram, TikTok, Snapchat, Facebook, X, BeReal) * Non-smoking * German language fluency * Attending age-appropriate school Exclusion Criteria: * Any neurological or psychiatric disease based on the standardized diagnostic interview (Kinder-DIPS) * Medical problems such as hormonal, metabolic, developmental or chronic diseases (e.g., congenital disorders, diabetes, dysfunctions of the thyroid, or congestive heart failure) * Pregnancy * Females who gave birth or were breastfeeding within the last year * Use of any other kind of steroid hormonal treatment (except combined oral contraceptives) or psychotropic treatment in the last three months * Females with premenstrual dysphoric disorder(PMDD) * Not willing to be informed about incidental fMRI findings Additional exclusion criteria for fMRI: * Individuals with non-removable metal objects on or in the body such as cardiac pacemaker, artificial heart valve, metal prostheses, metal implants, metal splinters, etc. * Tattoos (if fMRI-incompatible according to expert guidelines) * Claustrophobia * Surgery less than three months ago * Pathological hearing or increased sensitivity to loud noises * Neurological disease or injury * Moderate or severe head injury * Restricted (corrected) vision **Healthy Volunteers:** True **Maximum Age:** 18 Years **Minimum Age:** 15 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - CHILD - ADULT **Study Population:** The study participants will be primarily recruited from residents of Tübingen and surrounding areas. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Edita Karavidaj, MSc **Phone:** +491746443856 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Isabel Brandhorst, Dr. Dipl.-Psych. **Role:** CONTACT #### Locations **Location 1:** **City:** Tuebingen **Country:** Germany **Facility:** University Clinic Tuebingen, Department of Psychiatry & Psychotherapy **State:** Baden-Wuerttemberg **Zip:** 72076 #### Overall Officials **Official 1:** **Affiliation:** Child Psychiatry, University Clinic Tübingen **Name:** Tobias Renner, Prof. Dr. med. **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Department of Psychology, Uppsala University, Sweden **Name:** Tomas Furmark, Dr. **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M6494 - Name: Contraceptive Agents - Relevance: LOW - As Found: Unknown - ID: M6500 - Name: Contraceptives, Oral - Relevance: LOW - As Found: Unknown - ID: M6501 - Name: Contraceptives, Oral, Combined - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426446 **Acronym:** TELE-SEMA **Brief Title:** Monitoring Patients With Severe Obesity Treated With Wegovy® Using Connected Device: Real-world Data **Official Title:** Monitoring Patients With Severe Obesity Treated With Wegovy® Using Connected Device: Real-world Data #### Organization Study ID Info **ID:** APHP230587 #### Organization **Class:** OTHER **Full Name:** Assistance Publique - Hôpitaux de Paris ### Status Module #### Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** BPIfrance **Class:** INDUSTRY **Name:** Withings #### 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:** This study involves collecting real-world data on body weight, body composition, cardiovascular parameters, and neurovegetative parameters using a connected scale in patients with severe obesity treated with Wegovy®. **Detailed Description:** Obesity is a chronic disease associated with numerous co-morbidities. New treatments for obesity, notably GLP-1 (Glucagon-like peptide 1) analogs, have led to promising advances. Semaglutide 2.4 mg weekly subcutaneous injection, marketed under the brand name Wegovy®, was recently approved in France for weight loss in patients with severe obesity and at least one comorbidity. Several real-world studies have confirmed the effectiveness of semaglutide in reducing body weight and HbA1c. However, few studies have evaluated the kinetics and interindividual variability of changes in body weight and composition as well as cardiovascular health. There appears to be a need for a comprehensive real-world assessment of patients living with severe obesity receiving Wegovy®. The TELE-SEMA project involves collecting real-world data on body weight, body composition, cardiovascular and neurovegetative parameters via connected scales in patients with severe obesity treated with Wegovy®. The main objectives will be to assess inter-individual weight variability and explore the determinants that may influence weight loss, body composition and possible eating disorders. ### Conditions Module **Conditions:** - Obesity **Keywords:** - Obesity - Wegovy - Semaglutide 2.4 mg/week ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients receiving connected scale **Intervention Names:** - Device: Withings Body Comp Pro **Label:** Connected scale **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Connected scale **Description:** Withings Body Comp Pro from which the following features will be used: body weight, body composition (fat, muscle and bone mass, cardiovascular health (pulse wave velocity, arterial stiffness, vascular age, standing heart rate), nervous health (electrochemical skin conductance) **Name:** Withings Body Comp Pro **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Body weight measured at month 0 and 6 **Measure:** The relative difference in weight loss achieved at 6 months of treatment at the maximum tolerated dose ((weight after 6 months of treatment at the maximum tolerated dose - baseline weight) / baseline weight) **Time Frame:** 6 months #### Secondary Outcomes **Description:** Body weight measured weekly **Measure:** The variation of body weight measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose **Time Frame:** 6 months **Description:** Body composition measured weekly **Measure:** The variation of body composition (fat mass, muscle mass, and bone mass) measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose **Time Frame:** 6 months **Description:** Pulse wave velocity **Measure:** The variation of pulse wave velocity measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose **Time Frame:** 6 months **Description:** Arterial stiffness **Measure:** The variation of arterial stiffness measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose **Time Frame:** 6 months **Description:** Vascular age **Measure:** The variation of vascular age measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose **Time Frame:** 6 months **Description:** Heart rate **Measure:** The variation of heart rate measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose **Time Frame:** 6 months **Description:** Nervous system health measured weekly **Measure:** The variation of nervous system health (electrochemical skin conductance) measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose **Time Frame:** 6 months **Description:** Pulse wave velocity at month 0 and 6 **Measure:** Difference in mean pulse wave velocity before and after 6 months of treatment with semaglutide at the maximum tolerated dose **Time Frame:** 6 months **Description:** Arterial stiffness at month 0 and 6 **Measure:** Difference in mean arterial stiffness before and after 6 months of treatment with semaglutide at the maximum tolerated dose **Time Frame:** 6 months **Description:** Vascular age at month 0 and 6 **Measure:** Difference in mean vascular age before and after 6 months of treatment with semaglutide at the maximum tolerated dose **Time Frame:** 6 months **Description:** Heart rate at month 0 and 6 **Measure:** Difference in mean heart rate before and after 6 months of treatment with semaglutide at the maximum tolerated dose **Time Frame:** 6 months **Description:** Eating behavior at month 0 and 6 **Measure:** Difference in eating behavior assessed by the BES questionnaire before and after 6 months of treatment with semaglutide at the maximum tolerated dose **Time Frame:** 6 months **Description:** Level of physical activity at month 0 and 6 **Measure:** Difference in the level of physical activity assessed by the IPAQ short version questionnaire before and after 6 months of treatment with semaglutide at the maximum tolerated dose **Time Frame:** 6 months **Description:** missed doses compared to the total number of prescribed doses at month 6 **Measure:** Percentage of missed doses compared to the total number of prescribed doses after 6 months of treatment at the maximum tolerated dose **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Man or woman aged over 18 years * Patients who have reached the maximum dose of their treatment with Wegovy® * Written consent Exclusion Criteria: * Patient on AME (state medical aid) * Pregnant or breastfeeding woman * Patient who does not speak French * Adults under legal protection **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Josephine BRAUN **Phone:** 01 44 84 17 38 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Liliane HAMMANI-BERKANI **Phone:** 01 56 09 37 62 **Role:** CONTACT #### Locations **Location 1:** **City:** Paris **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Sébastien Czernichow, MD, PhD - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Nathalie Alrassy, PhD - **Role:** CONTACT **Country:** France **Facility:** Hôpital européen Georges Pompidou - APHP **Zip:** 75015 #### Overall Officials **Official 1:** **Affiliation:** Assistance Publique - Hôpitaux de Paris **Name:** Sébastien Czernichow, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR) **Description:** Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared **Info Types:** - STUDY_PROTOCOL - ICF **IPD Sharing:** YES **Time Frame:** Two years after the last publication ### References Module #### References **Citation:** World Obesity Federation. World obesity atlas 2022. Ludgate House, London; 2022. **Citation:** ANAES. Rapport sur la chirurgie de l'obésité morbide de l'adulte. 2001. **Citation:** Czernichow S, Renuy A, Rives-Lange C, Carette C, Airagnes G, Wiernik E, Ozguler A, Kab S, Goldberg M, Zins M, Matta J. Evolution of the prevalence of obesity in the adult population in France, 2013-2016: the Constances study. Sci Rep. 2021 Jul 8;11(1):14152. doi: 10.1038/s41598-021-93432-0. **PMID:** 34238998 **Citation:** Pan A, Sun Q, Czernichow S, Kivimaki M, Okereke OI, Lucas M, Manson JE, Ascherio A, Hu FB. Bidirectional association between depression and obesity in middle-aged and older women. Int J Obes (Lond). 2012 Apr;36(4):595-602. doi: 10.1038/ijo.2011.111. Epub 2011 Jun 7. **PMID:** 21654630 **Citation:** Schneider P, Popkin B, Shekar M, Eberwein JD, Block C, Okamura KS. Health and Economic Impacts of Overweight/Obesity. In: Obesity: Health and Economic Consequences of an Impending Global Challenge [Internet]. The World Bank; 2020 [cited 2021 Nov 5]. p. 69-94. (Human Development Perspectives). Available from: https://elibrary.worldbank.org/doi/10.1596/978-1-4648-1491-4_ch3 **Citation:** Thereaux J, Lesuffleur T, Czernichow S, Basdevant A, Msika S, Nocca D, Millat B, Fagot-Campagna A. Long-term adverse events after sleeve gastrectomy or gastric bypass: a 7-year nationwide, observational, population-based, cohort study. Lancet Diabetes Endocrinol. 2019 Oct;7(10):786-795. doi: 10.1016/S2213-8587(19)30191-3. Epub 2019 Aug 2. **PMID:** 31383618 **Citation:** Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10. **PMID:** 33567185 **Citation:** Wilding JPH, Batterham RL, Calanna S, Van Gaal LF, McGowan BM, Rosenstock J, et al. Impact of Semaglutide on Body Composition in Adults With Overweight or Obesity: Exploratory Analysis of the STEP 1 Study. J Endocr Soc. 2021 May 3;5(Suppl 1):A16-7. **Citation:** Kosiborod MN, Bhatta M, Davies M, Deanfield JE, Garvey WT, Khalid U, Kushner R, Rubino DM, Zeuthen N, Verma S. Semaglutide improves cardiometabolic risk factors in adults with overweight or obesity: STEP 1 and 4 exploratory analyses. Diabetes Obes Metab. 2023 Feb;25(2):468-478. doi: 10.1111/dom.14890. Epub 2022 Oct 28. **PMID:** 36200477 **Citation:** Gabery S, Salinas CG, Paulsen SJ, Ahnfelt-Ronne J, Alanentalo T, Baquero AF, Buckley ST, Farkas E, Fekete C, Frederiksen KS, Helms HCC, Jeppesen JF, John LM, Pyke C, Nohr J, Lu TT, Polex-Wolf J, Prevot V, Raun K, Simonsen L, Sun G, Szilvasy-Szabo A, Willenbrock H, Secher A, Knudsen LB, Hogendorf WFJ. Semaglutide lowers body weight in rodents via distributed neural pathways. JCI Insight. 2020 Mar 26;5(6):e133429. doi: 10.1172/jci.insight.133429. **PMID:** 32213703 **Citation:** Wharton S, Batterham RL, Bhatta M, Buscemi S, Christensen LN, Frias JP, Jodar E, Kandler K, Rigas G, Wadden TA, Garvey WT. Two-year effect of semaglutide 2.4 mg on control of eating in adults with overweight/obesity: STEP 5. Obesity (Silver Spring). 2023 Mar;31(3):703-715. doi: 10.1002/oby.23673. Epub 2023 Jan 18. **PMID:** 36655300 **Citation:** BROWN RE, LIU AR, MAHBUBANI R, ARONSON R. 995-P: Semaglutide in Patients with Type 2 Diabetes: Real-World Analysis in the Canadian LMC Diabetes Registry: The SPARE Study. Diabetes. 2019 Jun 1;68(Supplement_1):995-P. **Citation:** VISARIA J, DANG-TAN T, PETRARO PV, NEPAL BK, WILLEY V. 1006-P: Real-World Effectiveness of Semaglutide in Early Users from a U.S. Commercially Insured (CI) and Medicare Advantage (MA) Population. Diabetes. 2019 Jun 1;68(Supplement_1):1006-P. **Citation:** Di Loreto C, Minarelli V, Nasini G, Norgiolini R, Del Sindaco P. Effectiveness in Real World of Once Weekly Semaglutide in People with Type 2 Diabetes: Glucagon-Like Peptide Receptor Agonist Naive or Switchers from Other Glucagon-Like Peptide Receptor Agonists: Results from a Retrospective Observational Study in Umbria. Diabetes Ther. 2022 Mar;13(3):551-567. doi: 10.1007/s13300-022-01218-y. Epub 2022 Mar 1. Erratum In: Diabetes Ther. 2022 Jun;13(6):1251. **PMID:** 35230650 **Citation:** Rajamand Ekberg N, Bodholdt U, Catarig AM, Catrina SB, Grau K, Holmberg CN, Klanger B, Knudsen ST. Real-world use of once-weekly semaglutide in patients with type 2 diabetes: Results from the SURE Denmark/Sweden multicentre, prospective, observational study. Prim Care Diabetes. 2021 Oct;15(5):871-878. doi: 10.1016/j.pcd.2021.06.008. Epub 2021 Jun 25. **PMID:** 34183269 **Citation:** Garcia de Lucas MD, Miramontes-Gonzalez JP, Aviles-Bueno B, Jimenez-Millan AI, Rivas-Ruiz F, Perez-Belmonte LM. Real-world use of once-weekly semaglutide in patients with type 2 diabetes at an outpatient clinic in Spain. Front Endocrinol (Lausanne). 2022 Sep 16;13:995646. doi: 10.3389/fendo.2022.995646. eCollection 2022. **PMID:** 36187123 **Citation:** Yale JF, Bodholdt U, Catarig AM, Catrina S, Clark A, Ekberg NR, Erhan U, Holmes P, Knudsen ST, Liutkus J, Sathyapalan T, Schultes B, Rudofsky G. Real-world use of once-weekly semaglutide in patients with type 2 diabetes: pooled analysis of data from four SURE studies by baseline characteristic subgroups. BMJ Open Diabetes Res Care. 2022 Apr;10(2):e002619. doi: 10.1136/bmjdrc-2021-002619. **PMID:** 35383100 **Citation:** Stewart T, Han H, Allen RH, Bathalon G, Ryan DH, Newton RL Jr, Williamson DA. H.E.A.L.T.H.: efficacy of an internet/population-based behavioral weight management program for the U.S. Army. J Diabetes Sci Technol. 2011 Jan 1;5(1):178-87. doi: 10.1177/193229681100500125. **PMID:** 21303642 **Citation:** Beleigoli AM, Andrade AQ, Cancado AG, Paulo MN, Diniz MFH, Ribeiro AL. Web-Based Digital Health Interventions for Weight Loss and Lifestyle Habit Changes in Overweight and Obese Adults: Systematic Review and Meta-Analysis. J Med Internet Res. 2019 Jan 8;21(1):e298. doi: 10.2196/jmir.9609. **PMID:** 30622090 **Citation:** Garcia-Ulloa AC, Almeda-Valdes P, Aguilar-Salinas CA, Hernandez-Jimenez S; Group of Study CAIPaDi. Development and Validation of a Software Linked to an Internet Portal That Facilitates the Medical Treatment and Empowerment of Patients with Type 2 Diabetes, Interaction with Medical Personnel, and the Generation of a Real-Time Registry. J Diabetes Sci Technol. 2021 Mar;15(2):525-527. doi: 10.1177/1932296820949941. Epub 2020 Aug 19. No abstract available. **PMID:** 32814459 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000050177 - Term: Overweight - 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: M12701 - Name: Obesity - Relevance: HIGH - As Found: Obesity - ID: M12702 - Name: Obesity, Morbid - Relevance: HIGH - As Found: Severe 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: D000009765 - Term: Obesity - ID: D000009767 - Term: Obesity, Morbid ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M353561 - Name: Semaglutide - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426433 **Brief Title:** Investigation of The Effects of Proprioceptive Exercise Training on Motor Performance Parameters in Healthy Adults **Official Title:** Investigation of The Effects of Proprioceptive Exercise Training on Motor Performance Parameters in Healthy Adults #### Organization Study ID Info **ID:** E-94603339-604.01.02-268134 #### Organization **Class:** OTHER **Full Name:** Hacettepe University ### Status Module #### Completion Date **Date:** 2023-12-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-12-31 **Type:** ACTUAL #### Start Date **Date:** 2023-06-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hacettepe University #### Responsible Party **Investigator Affiliation:** Hacettepe University **Investigator Full Name:** Cigdem Ayhan **Investigator Title:** Professor Doctor of Physical Therapy and Rehabilitation Faculty **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 was conducted to investigate the effect of two different exercise protocols applied to healthy individuals on motor performance parameters. Forty-one healthy participants were included in the study. Participants were divided into 2 groups (wrist proprioceptive exercise group, general exercise group) and attended exercise training targeting the hand and wrist for a total of 6 weeks. Before and after the exercises, sociodemographic evaluation, Quick Disability of Arm Shoulder and Hand questionnaire, pain assessment, grip strength measurement, weight transfer tolerance test, wrist joint position sense, Nelson hand reaction test, upper extremity Y balance test, lateral grip and tripod grip measurements, manual muscle testing, and surface electromyography analysis were evaluated in both groups. **Detailed Description:** Healthy volunteers who met the inclusion criteria were included in the study upon agreement to participate. The participants were divided into two groups. One group received 6 weeks of general upper extremity exercises along with proprioceptive exercise training. The proprioceptive exercise training consisted of a 10-minute warm-up period including active and passive upper extremity exercises followed by 30 minutes of proprioceptive exercises. The exercise program progressed weekly, and exercises were performed in standardized positions. To ensure adherence to the exercises, they were recorded on video and sent to participants' phones. The second group performed general upper extremity exercises for 6 weeks. The reason for creating the second group was to eliminate the time-dependent effect of changes in electromyographic activation levels of muscles. Additionally, the bilateral effects of unilateral upper extremity exercise training are observed. Comparing the electromyographic activities of untrained healthy individuals at the end of the treatment may enhance the quality of data interpretation. However, other factors that increase the risk of error in evaluating distal motor performance of the upper extremity were also considered in our study. It is expected that the motor performance of the dominant side will be greater than that of the non-dominant side. However, the non-dominant side is more frequently used in daily activities, resulting in a higher frequency and intensity of daily life activities being loaded onto the dominant side. To reduce the potential error resulting from daily life activities, exercise training was given to the non-dominant side of the healthy individuals participating in our study. Detailed evaluations were performed on the individuals participating in the study, as described below. Evaluations were conducted twice, before starting the exercise program and after the 6-week exercise program. ### Conditions Module **Conditions:** - Exercise - Proprioception - Wrist Injuries **Keywords:** - Wrist - Proprioception ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### 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:** Wrist Proprioceptive Exercises are neuromuscular exercises for wrist stabilization and control. **Intervention Names:** - Other: Proprioceptive Exercises - Other: Upper Extremity Exercises **Label:** Wrist Proprioceptive Exercises and General Upper Extremity Exercises **Type:** OTHER #### Arm Group 2 **Description:** These exercises are traditional rehabilitation exercises. **Intervention Names:** - Other: Upper Extremity Exercises **Label:** General Upper Extremity Exercises **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Wrist Proprioceptive Exercises and General Upper Extremity Exercises **Description:** In our study, participants were divided into two different exercise groups, starting with the same warm-up exercise program, and a 6-week exercise training program was implemented. To reduce the potential error resulting from daily life activities, exercise training was given to the non-dominant side of the participants. Proprioceptive exercises aim to restore muscle balances, unconscious joint control with reactive muscle activations and feedforward joint control. **Name:** Proprioceptive Exercises **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - General Upper Extremity Exercises - Wrist Proprioceptive Exercises and General Upper Extremity Exercises **Description:** In our study, participants were divided into two different exercise groups, starting with the same warm-up exercise program, and a 6-week exercise training program was implemented. To reduce the potential error resulting from daily life activities, exercise training was given to the non-dominant side of the participants. Upper extremity exercises are traditional rehabilitation exercises for strength, endurance and range of motion. **Name:** Upper Extremity Exercises **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Measurement of wrist muscles activation levels **Measure:** Surface Electromyography **Time Frame:** Within the week before starting the exercise and within the week after finishing the exercise #### Secondary Outcomes **Description:** Measurement of hand grip force **Measure:** Grip Force **Time Frame:** Within the week before starting the exercise and within the week after finishing the exercise **Description:** Measurement of weight bearing capacity of healthy wrist **Measure:** Weight Bearing Tolerance Test **Time Frame:** Within the week before starting the exercise and within the week after finishing the exercise **Description:** Measurement of position senses for 4 wrist range of motion directions **Measure:** Joint Position Sense **Time Frame:** Within the week before starting the exercise and within the week after finishing the exercise **Description:** Measurement of Nelson hand reaction time **Measure:** Reaction time **Time Frame:** Within the week before starting the exercise and within the week after finishing the exercise **Description:** Measurement of upper extremity balance and mobility **Measure:** Upper extremity y balance test **Time Frame:** Within the week before starting the exercise and within the week after finishing the exercise **Description:** Measurement of tripod hand grip force **Measure:** Tripod grip **Time Frame:** Within the week before starting the exercise and within the week after finishing the exercise **Description:** Measurement of lateral hand grip force **Measure:** Lateral grip **Time Frame:** Within the week before starting the exercise and within the week after finishing the exercise **Description:** Measurement of manual muscle dynamometer **Measure:** Manual muscle test **Time Frame:** Within the week before starting the exercise and within the week after finishing the exercise ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * To be between the ages of 18 and 30 * To be willing to participate in the study * To have cognitive abilities to understand the tasks required in the study. Exclusion Criteria: * Experiencing acute/chronic bilateral or unilateral upper extremity pain * Having neurological and/or rheumatological diseases * Chronic medication usage * Regular smoking/alcohol consumption currently or in the past * Taking cortisone orally or via injection * Suffering from upper extremity musculoskeletal injuries in the past year * Undergoing upper extremity surgery * Having a body mass index greater than 24.9 kg/m2 * Scoring above 6 on the Beighton hypermobility score * Engaging in regular exercises involving the upper extremities * History of autoimmune and/or rheumatic diseases * Regular use of anti-inflammatory medications, etc. * Having cardiovascular disease and diabetes **Maximum Age:** 30 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Ankara **Country:** Turkey **Facility:** Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation **Zip:** 06100 #### Overall Officials **Official 1:** **Affiliation:** Hacettepe University **Name:** Semiha Tomiris Erzincanlı, MSc Student **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001134 - Term: Arm Injuries - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M17692 - Name: Wrist Injuries - Relevance: HIGH - As Found: Wrist Injuries - ID: M4444 - Name: Arm Injuries - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014954 - Term: Wrist Injuries ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426420 **Brief Title:** Endometriosis and ATR-FTIR Spectroscopy **Official Title:** Detection of Endometriosis Using ATR-FTIR Spectroscopy #### Organization Study ID Info **ID:** FTIR-ENDOMETRIOSIS #### Organization **Class:** OTHER **Full Name:** Federal University of Espirito Santo ### Status Module #### Completion Date **Date:** 2026-04-29 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-26 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-04-29 **Type:** ESTIMATED #### Start Date **Date:** 2022-09-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Conselho Nacional de Desenvolvimento Científico e Tecnológico #### Lead Sponsor **Class:** OTHER **Name:** Federal University of Espirito Santo #### Responsible Party **Investigator Affiliation:** Federal University of Espirito Santo **Investigator Full Name:** VALERIO GARRONE BARAUNA **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 goal of this study is to explore the use of mid-infrared spectroscopy (ATR-FTIR) as a detection tool for endometriosis in urine. **Detailed Description:** Endometriosis is a chronic gynecological disease that is considered debilitating and multifactorial. Its diagnosis is invasive and can be prolonged due to non-specific symptoms and erroneous or late investigations, which can lead to delays and impair the provision of adequate treatment. ATR-FTIR Spectroscopy is a non-invasive technique with the capability to identify the chemical composition and molecular changes of samples through its interaction with mid-infrared radiation. The aim of this work is to develop a rapid test for the detection of endometriosis in urine samples using spectroscopy and machine learning algorithms. ### Conditions Module **Conditions:** - Endometriosis - Endometriomas **Keywords:** - Endometriosis - Diagnosis - Spectroscopy - FTIR - Urine - Detection - Infrared ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 600 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients referred to the gynecology outpatient clinic, with complain of pelvic pain. Positives and negatives for endometriosis will be outlined by an expert gynecologist according to the following criteria: * Pelvic MRI (Magnetic Resonance Imaging) report; * Gynecologic exam; * Clinical symptoms and history; The intervention is the use of the ATR-FTIR Spectrometer in patient's urine samples to develop and validate a tool for detecting endometriosis. **Intervention Names:** - Diagnostic Test: FTIR spectroscopy analysis **Label:** Pelvic Pain **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Pelvic Pain **Description:** ATR-FTIR Spectroscopy analysis combined with machine learning algorithms. **Name:** FTIR spectroscopy analysis **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** The primary outcome is the evaluation of specificity, sensitivity and accuracy of the diagnostic. Acceptable diagnostic metrics must be comparable to MRI, which will demonstrate if spectroscopy can discriminate between negative and positive endometriosis patients. **Measure:** Spectroscopy Reliability (diagnostic metrics) **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Female * Pelvic pain complain Exclusion Criteria: * Age under 18 or above 55 * Lack of informed consent **Gender Based:** True **Gender Description:** Biological woman self-identified as woman **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Valerio G Barauna, PhD **Phone:** +5527996892407 **Role:** CONTACT #### Locations **Location 1:** **City:** Vitória **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Neide A Boldrini, phD - **Phone:** +552733357100 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Mara RB Barcelos, phD - **Phone:** +5527999829511 - **Role:** CONTACT ***Contact 3:*** - **Name:** Neide A Boldrini, phD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Mara RB Barcelos, phD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Brazil **Facility:** University Hospital Cassiano Antonio Moraes at Federal Univeristy Of Espírito Santo **State:** Espírito Santo **Status:** RECRUITING **Zip:** 29041-295 #### Overall Officials **Official 1:** **Affiliation:** Universidade Federal do Espírito Santo **Name:** Valerio G Barauna, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000091662 - Term: Genital 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: M7877 - Name: Endometriosis - Relevance: HIGH - As Found: Endometriosis - ID: M8943 - Name: Genital Diseases, Female - 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 - 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 ### Condition Browse Module - Meshes - ID: D000004715 - Term: Endometriosis ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426407 **Brief Title:** Vasopressin Hemodynamic Response as a Septic Shock Subphenotype Indicator **Official Title:** Vasopressin Hemodynamic Response as a Septic Shock Subphenotype Indicator #### Organization Study ID Info **ID:** 21-047 #### Organization **Class:** OTHER **Full Name:** The Cleveland Clinic ### Status Module #### Completion Date **Date:** 2026-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-02-16 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The Cleveland Clinic #### Responsible Party **Investigator Affiliation:** The Cleveland Clinic **Investigator Full Name:** Seth Bauer **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this observational study is to learn about blood pressure response to the vasopressor drug vasopressin in people with septic shock. The main questions it aims to answer are: * Are the levels of molecules showing communication between cells different between people whose blood pressure improves and people whose blood pressure does not improve when given a vasopressor medication? * Are measurements found on echocardiography (heart ultrasound) different between people whose blood pressure improves and people whose blood pressure does not improve when given a vasopressor medication? Participants will be asked to contribute one or two blood samples. Participants who are ordered the drug vasopressin will contribute two blood samples. Both samples will be about two tablespoons for a total of about four tablespoons. One sample will be drawn before starting vasopressin infusion and the second sample will be drawn between one and six hours after starting the vasopressor drug infusion. At the same time points, advanced echocardiography pictures will be taken. Participants who are not ordered the drug vasopressin and only ordered the drug norepinephrine will contribute only one sample. At the time the sample is collected, advanced echocardiography pictures will be taken. This research also involves analyzing data obtained during the participant's hospital stay. **Detailed Description:** Septic shock mortality remains high at 33% in North America; current clinical predictors of poor outcomes in septic shock are suboptimal. In addition to antibiotics and intravenous fluids, vasoactive agents are initiated to restore effective tissue perfusion. Norepinephrine (NE) is the recommended first-line vasopressor, but adjunctive arginine vasopressin is used in over one-third of patients to improve blood pressure or decrease NE dosage. However, less than half of vasopressin recipients have a clinically-apparent hemodynamic response (defined as a decrease in NE dosage at 6 hours after vasopressin initiation). Vasopressors, particularly norepinephrine, are known to be immune modulators. Further, each vasopressor has its own unique effect on a patient's hemodynamic profile as assessed by echocardiography. In the current study, the investigators seek to clarify the link between vasopressin, immune response, and hemodynamic profile. The central goal of this proposal is to identify "vasopressin response" as an easily-identifiable bedside indicator of a distinct septic shock subphenotype. ### Conditions Module **Conditions:** - Shock, Septic ### Design Module #### Bio Spec **Description:** Blood collected into EDTA test tubes **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 48 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with septic shock ordered vasopressin as an adjunct to norepinephrine **Intervention Names:** - Drug: Vasopressin **Label:** Vasopressin plus norepinephrine #### Arm Group 2 **Description:** Active control cohort of patients with septic shock who are only receiving norepinephrine **Label:** Norepinephrine ### Interventions #### Intervention 1 **Arm Group Labels:** - Vasopressin plus norepinephrine **Description:** Fixed dosage vasopressin ordered as an adjunctive vasopressor to norepinephrine **Name:** Vasopressin **Other Names:** - antidiuretic hormone (ADH) - arginine vasopressin (AVP) **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Compare plasma interleukin-1β (IL-1β) concentration over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Plasma interleukin-1β (IL-1β) concentration **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare plasma interleukin-6 (IL-6) concentration over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Plasma interleukin-6 (IL-6) concentration **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare plasma interferon-gamma (IFN-γ) concentration over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Plasma interferon-gamma (IFN-γ) concentration **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare plasma C-X-C motif chemokine ligand 10 (CXCL10, also known as interferon gamma-induced protein 10 \[IP-10\]) concentration over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Plasma C-X-C motif chemokine ligand 10 (CXCL10, also known as interferon gamma-induced protein 10 [IP-10]) concentration **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare plasma granulocyte-colony stimulating factor (G-CSF) concentration over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Plasma granulocyte-colony stimulating factor (G-CSF) concentration **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare plasma E-selectin concentration over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Plasma E-selectin concentration **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Evaluate the association of plasma vasopressin concentration with ratio of plasma interleukin-10 (IL-10) to tumor necrosis factor-α (TNF-α) over time. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Plasma vasopressin concentration **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare plasma copeptin concentration over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Plasma copeptin concentration **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare left ventricular ejection fraction (LVEF) over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Left ventricular ejection fraction (LVEF) change **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare stroke volume (SV) over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Stroke volume (SV) by echocardiography **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare tricuspid annular plane systolic excursion (TAPSE) over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Tricuspid annular plane systolic excursion (TAPSE) **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare tricuspid annular systolic plane velocity (TAPSV, also known as RV S') over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Tricuspid annular systolic plane velocity (TAPSV, also known as RV S') **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare venous-arterial carbon dioxide tension gradient (Pva-CO2) over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Venous-arterial carbon dioxide tension gradient (Pva-CO2) **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare central venous oxygen saturation (ScvO2) over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Central venous oxygen saturation (ScvO2) **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare dynamic arterial elastance (Eadyn) over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Dynamic arterial elastance (Eadyn, the ratio of pulse pressure variation to stroke volume variation) **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare the ordinal outcome clinical trajectory (comprised of rapid recovery, chronic critical illness, and early recovery) between vasopressin responders vs. non-responders. **Measure:** Clinical trajectory **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through the sooner of intensive care unit discharge or 14 days. **Description:** Compare the incidence of hospital mortality in vasopressin responders vs. non-responders. **Measure:** Incidence of in-hospital mortality **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through hospital discharge. **Description:** Compare intensive care unit length of stay in vasopressin responders vs. non-responders. **Measure:** Intensive care unit length of stay **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through intensive care unit discharge. #### Primary Outcomes **Description:** Compare baseline ratio of plasma concentrations of interleukin-10 (IL-10) to tumor necrosis factor-α (TNF-α) in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Ratio of plasma interleukin-10 (IL-10) to tumor necrosis factor-α (TNF-α) **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement). #### Secondary Outcomes **Description:** Compare baseline left ventricular ejection fraction (LVEF) in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Left ventricular ejection fraction (LVEF) **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement). **Description:** Compare left ventricular-arterial coupling (ratio of arterial elastance \[Ea\] to left ventricular end-systolic elastance \[Ees\]) over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Ratio of ratio of arterial elastance (Ea) to left ventricular end-systolic elastance (Ees) **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare lipopolysaccharide-stimulated monocyte TNF-α secretion over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Lipopolysaccharide-stimulated monocyte TNF-α secretion **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare monocyte adhesion over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Monocyte adhesion **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare plasma renin concentration over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Plasma renin concentration **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. **Description:** Compare plasma angiopoietin-2 concentration over time in vasopressin responders vs. non-responders. The active control cohort of patients who are only receiving norepinephrine will serve as a control for this analysis. **Measure:** Plasma angiopoietin-2 concentration **Time Frame:** Baseline (before vasopressin initiation and within 30 minutes of order placement) through one to six hours after vasopressin initiation. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult patients (≥18 years old) * Septic shock (as defined by Sepsis-3) * Receiving norepinephrine * Admitted to a medical, surgical, NeuroSciences, or mixed intensive care unit * Central venous catheter in place * Ordered fixed-dose vasopressin as an adjunct to norepinephrine by the primary care team (unless in active control cohort) Exclusion Criteria: * Vasopressin ordered for an indication other than septic shock * Vasopressin initiated at another institution * Receiving a primary vasopressor other than norepinephrine (eg, phenylephrine) * Positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within the preceding 28 days * Blood hemoglobin concentration \<7 g/dL * Primary treatment team determines that vasopressin initiation is emergent * Patient or their legal authorized representative opts to not participate in the study **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adult patients with septic shock are eligible for this study. Patients ordered vasopressin as an adjunct to norepinephrine as part of routine care comprise the primary cohort of interest. An active control cohort of patients who are only receiving norepinephrine will also be enrolled. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Seth Bauer, PharmD **Phone:** 2169522553 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** The Cleveland Clinic **Name:** Seth Bauer, PharmD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Individual participant data may be available through reasonable request to the study principal investigator and completion of a data use agreement. **Description:** Individual participant data may be available through reasonable request to the study principal investigator and completion of a data use agreement. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** Study data will become available at the time of initial manuscript publication and remain available for 5 years after initial manuscript publication. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000018805 - Term: Sepsis - ID: D000007239 - Term: Infections - ID: D000018746 - Term: Systemic Inflammatory Response Syndrome - ID: D000007249 - Term: Inflammation ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections ### Condition Browse Module - Browse Leaves - ID: M15577 - Name: Shock - Relevance: HIGH - As Found: Shock - ID: M15580 - Name: Shock, Septic - Relevance: HIGH - As Found: Shock, Septic - ID: M20864 - Name: Sepsis - Relevance: LOW - As Found: Unknown - ID: M16869 - Name: Toxemia - 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: M20818 - Name: Systemic Inflammatory Response Syndrome - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012772 - Term: Shock, Septic - ID: D000012769 - Term: Shock ### Intervention Browse Module - Ancestors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000006490 - Term: Hemostatics - ID: D000003029 - Term: Coagulants - ID: D000014662 - Term: Vasoconstrictor Agents - ID: D000050034 - Term: Antidiuretic Agents - ID: D000045283 - Term: Natriuretic Agents ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: NaAg - Name: Natriuretic Agents - Abbrev: VaCoAg - Name: Vasoconstrictor Agents - Abbrev: Coag - Name: Coagulants - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M17414 - Name: Vasopressins - Relevance: HIGH - As Found: Oximetry - ID: M4437 - Name: Arginine Vasopressin - Relevance: HIGH - As Found: Oximetry - ID: M12575 - Name: Norepinephrine - Relevance: LOW - As Found: Unknown - ID: M17409 - Name: Vasoconstrictor Agents - Relevance: LOW - As Found: Unknown - ID: M9576 - Name: Hemostatics - Relevance: LOW - As Found: Unknown - ID: M6259 - Name: Coagulants - Relevance: LOW - As Found: Unknown - ID: T1 - Name: Arginine - Relevance: HIGH - As Found: Every 21 days ### Intervention Browse Module - Meshes - ID: D000014667 - Term: Vasopressins - ID: D000001127 - Term: Arginine Vasopressin ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426394 **Brief Title:** Effect of Positive End-expiratory Pressure on Gastic Residual Volume **Official Title:** The Effect of End-expiratory Positive Pressure on Gastric Residual Volume in Elective Pediatric Outpatient Surgery Where Laryngeal Mask is Applied #### Organization Study ID Info **ID:** 2023-541 #### Organization **Class:** OTHER_GOV **Full Name:** Bakirkoy Dr. Sadi Konuk Research and Training Hospital ### Status Module #### Completion Date **Date:** 2025-01-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Başakşehir Çam & Sakura City Hospital #### Lead Sponsor **Class:** OTHER_GOV **Name:** Duygu Akyol #### Responsible Party **Investigator Affiliation:** Bakirkoy Dr. Sadi Konuk Research and Training Hospital **Investigator Full Name:** Duygu Akyol **Investigator Title:** M.D, co-investigator **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study was designed as a prospective observational study. **Detailed Description:** In this study, it was planned to evaluate the effect of positive end-expiratory pressure on gastric residual volume in patients who will undergo outpatient pediatric surgery with laryngeal mask application on the specified dates. Patients aged 1-11 years, ASA I-II and undergoing outpatient lower abdominal and genitourinary surgery were included in the study. Since the use of positive end-expiratory pressure varies in our clinic depending on the anesthesiologist preference, the effect of this application on gastric volume will also be evaluated primarily by recording images with gastric ultrasonography at certain perioperative time periods. Secondarily, the effect of this positive end-expiratory pressure on mechanical ventilator parameters and airway pressures will be evaluated. ### Conditions Module **Conditions:** - Pediatrics - Fasting Period **Keywords:** - Gastric ultrasonography - gastric residual volume - pediatric outpatient surgery ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Day ### Outcomes Module #### Primary Outcomes **Description:** The primary purpose of this study is to measure gastric residual volume with peroperative gastric ultrasonography measurements. Gastric residual volume will be calculated according to gastric ultrasonography measurements. **Measure:** Gastric residual volume **Time Frame:** preoperatively, intraoperatively after laryngeal mask placement, before laryngeal mask removal at the end of surgery #### Secondary Outcomes **Description:** The secondary aim of this study was to evaluate the effect of positive end-expiratory pressures on airway pressures **Measure:** Airway pressures **Time Frame:** intraoperative process ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Pediatric patients who will undergo elective outpatient minor surgery (lower abdominal and urogenital) * 1-11 years old * American Society of Anesthesiology (ASA) classification 1-2 patient groups * Patients who are fully hungry and whose fasting period is appropriate for their age and diet. Exclusion Criteria: * Patients whose fasting period is not appropriate * Acute abdominal and emergency surgeries * ASA 3-4 patient group * Patients with diseases or medication use that will affect gastric emptying time * Previous nasogastric tube placement and re-operation • Patients with known difficult airway or failure to fit the laryngeal mask **Healthy Volunteers:** True **Maximum Age:** 11 Years **Minimum Age:** 1 Year **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD **Study Population:** A total of 90 patients were planned for this study. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Duygu Akyol, M.d **Phone:** +905447616034 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Musa Akdağ, M.d **Phone:** +905317347672 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Gunasekaran A, Govindaraj K, Gupta SL, Vinayagam S, Mishra SK. Comparison of Gastric Insufflation Volume Between Ambu AuraGain and ProSeal Laryngeal Mask Airway Using Ultrasonography in Patients Undergoing General Anesthesia: A Randomized Controlled Trial. Cureus. 2022 Aug 11;14(8):e27888. doi: 10.7759/cureus.27888. eCollection 2022 Aug. **PMID:** 36110490 **Citation:** Sharma G, Jacob R, Mahankali S, Ravindra MN. Preoperative assessment of gastric contents and volume using bedside ultrasound in adult patients: A prospective, observational, correlation study. Indian J Anaesth. 2018 Oct;62(10):753-758. doi: 10.4103/ija.IJA_147_18. **PMID:** 30443057 **Citation:** Beck CE, Rudolp D, Becke-Jakob K, Schindler E, Etspuler A, Trapp A, Fink G, Muller-Lobeck L, Roher K, Genahr A, Eich C, Sumpelmann R. Real fasting times and incidence of pulmonary aspiration in children: Results of a German prospective multicenter observational study. Paediatr Anaesth. 2019 Oct;29(10):1040-1045. doi: 10.1111/pan.13725. Epub 2019 Sep 4. **PMID:** 31435997 **Citation:** Fiedler MO, Schatzle E, Contzen M, Gernoth C, Weiss C, Walter T, Viergutz T, Kalenka A. Evaluation of Different Positive End-Expiratory Pressures Using Supreme Airway Laryngeal Mask during Minor Surgical Procedures in Children. Medicina (Kaunas). 2020 Oct 21;56(10):551. doi: 10.3390/medicina56100551. **PMID:** 33096743 ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426381 **Brief Title:** The Effect of Therapeutic Touch Applied During Knee Replacement Surgery on Anxiety, Vital Signs and Comfort Level **Official Title:** The Effect of Therapeutic Touch Applied During Knee Replacement Surgery on Anxiety, Vital Signs and Comfort Level / Experimental Randomized Controlled Trial #### Organization Study ID Info **ID:** ayse25 #### Organization **Class:** OTHER **Full Name:** Ataturk University ### Status Module #### Completion Date **Date:** 2024-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06 **Type:** ESTIMATED #### Start Date **Date:** 2023-11-04 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Dilek GÜRÇAYIR #### Responsible Party **Investigator Affiliation:** Ataturk University **Investigator Full Name:** Dilek GÜRÇAYIR **Investigator Title:** Academician **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The aim of this study is to investigate the effect of therapeutic touch on patients' anxiety, vital signs and comfort levels during knee replacement surgery performed under local anesthesia. The study will be completed with a total of 128 participants, including 64 experimental and 64 control participants. As a randomization method, the simple randomization method will be used to ensure an equal number of samples in two groups, and patients will be assigned to the experimental and control groups. In the research, patients will be given verbal information about the research, and written informed consent will be obtained from the patients who accept it. In the study, therapeutic touch was applied for 15-20 minutes during knee replacement surgery and the effect of this application on vital signs, anxiety level and comfort was evaluated. **Detailed Description:** Knee replacement surgeries are a common treatment method for patients with problems such as pain and limitation of movement resulting from knee joint disorders. This type of surgery is usually performed under general anesthesia, allowing patients to lose consciousness during surgery. However, general anesthesia may have some risks and complications. For this reason, local anesthesia has become increasingly popular. Local anesthesia is a method of anesthesia used to numb the surgical area. In this method, anesthesia is injected directly into the surgical area and the patient is awake and conscious throughout the surgery. Local anesthesia may have fewer side effects and complications compared to general anesthesia. However, the effects of emotional factors such as stress, anxiety and discomfort experienced by patients during surgeries performed under local anesthesia are still poorly understood . The human body is surrounded by an aura and open energy fields. It is reported that when these energy fields are balanced, the individual is healthy, and when they are irregular, the individual experiences health problems. Asymmetric energy fields can be balanced using the therapeutic touch method and treatment becomes easier. In this way, the person regains his health or can be helped to regain his health. Nursing theorist Martha Rogers supports this statement. Rogers defined human beings as an open system with a complex and interactive energy field covering the entire universe. It is assumed that the energy surrounding humans is in wave form and that changes in the human body are controlled by these energy fluctuations. If the person has health problems, this manifests itself in the form of energy blockages or rhythm disorders. By correcting these energy rhythm disorders discovered by the nurse with the therapeutic touch method, the person's health problem can be treated. In recent years, there has been increasing evidence that alternative approaches, such as therapeutic touch, have positive effects on surgical outcomes. Therapeutic touch is a method that aims to provide relaxation, calming and healing through physical contact. This method can reduce patients' stress levels, relieve pain, and increase their overall comfort level. However, there are limited studies on the effect of therapeutic touch on vital signs during knee replacement surgery performed under local anesthesia. Surgeries are widely used as a method of treating various health problems that require medical treatment. Knee prosthesis surgeries are one of the frequently used surgical interventions in the treatment of painful and limiting diseases of the knee joint. Although such surgeries have the potential to significantly improve individuals' mobility and quality of life, the stress, anxiety and physical discomfort that may occur during and after the surgery can be a significant source of concern for patients. Anxiety is a common psychological reaction before and after surgical interventions and is an important factor affecting the surgical process. Patients may experience increased levels of anxiety when faced with uncertainty about the results of surgery, possible complications, and the recovery process. The importance of this situation is of great importance in terms of the success of the surgery and the patients' ability to better manage the postoperative period. Anxiety negatively affects the patient's comfort level after surgery and can prolong the recovery process. Lack of comfort can lead to increased physical and emotional stress caused by surgery. It is important to note that because therapeutic touch has the potential to increase patients' relaxation, stress reduction, and overall comfort level, research has also been conducted in this area. However, there is no definitive information about the effect of therapeutic touch on the comfort level during knee replacement surgery performed under local anesthesia. The aim of this study is to investigate the effect of therapeutic touch on patients' vital signs, anxiety and comfort level during knee replacement surgery performed under local anesthesia. This study aims to offer an alternative approach to improve patients' quality of life by continuing to improve the results of surgeries performed under local anesthesia. This study aims to fill the gap in this field by investigating the effect of therapeutic touch on vital signs, anxiety and comfort level during knee replacement surgery performed under local anesthesia. The findings may guide clinical practice in providing an alternative approach to improve surgical outcomes and reduce discomfort experienced by patients. It may also provide basic information to evaluate the feasibility of therapeutic touch in other surgical procedures under local anesthesia. This study was conducted as an experimental randomized controlled study. This method was preferred because it allows the situations and attitudes of the individuals in the group selected as a sample, regarding a phenomenon or event, and to describe the phenomena and events in their own conditions and as they are. In addition, in randomized controlled studies, the factors that cause events and situations and the degree of influence of these factors can be determined. In the study, therapeutic touch was applied for 15-20 minutes during knee replacement surgery and the effect of this application on vital signs, anxiety level and comfort was evaluated. The hypotheses created in the research are listed below; The research was conducted in the orthopedics and traumatology room in the operating room department of Atatürk University Training and Research Hospital between September 2023 and June 2024. The population of the research consists of patients who had knee replacement surgery between September 2023 and February 2024. The sample of the research consists of patients who meet the inclusion criteria between the specified dates. Cohen's standard effect sizes were used as reference in the power analysis. In this case, in this study, for the t test in independent groups where the effect of therapeutic touch during knee prosthesis surgery will be compared on vital signs, anxiety and comfort levels, if the study is conducted with a total of 128 participants in two groups with 64 participants in each group, 80% confidence interval is 95% at a significance level of 0.05. It has been determined that power can be achieved. As a randomization method, the "simple randomization method" was used to ensure an equal number of samples in two groups, and the patients were assigned to the experimental and control groups. In the study, patients were given verbal information about the research, and written informed consent was obtained from the patients who agreed. Four different forms were used to collect data in the study. The Anxiety and Comfort Scale, which was determined as the data collection tool in the study, was chosen by the researcher as it was deemed suitable for the purpose. Analyzes were carried out with the data obtained to test the validity and reliability of the selected scale. In order to ensure that the data collection tools do not pose an ethical problem, people with expertise on the subject were consulted and it was ensured that they would not cause any problems. However, the scale questions were reviewed in detail by the researcher and the consultant, and since an application was actually made in the form of a Likert scale, leaving the selection decision entirely to the participants refutes the idea that it is a manipulation. The forms used to collect data are listed below; 1. Patient Introduction Form 2. Vital Signs Record Form 3. Spielberg State-Trait Anxiety Scale 4. Perianesthesia Comfort Scale (PCS) In order to conduct the research, firstly, approval was obtained from the Atatürk University Faculty of Medicine Ethics Committee and institutional permission was obtained from the hospital where the research was conducted. Verbal consent was obtained from the patients before data collection, and data collection forms were collected by the researcher in the orthopedics and traumatology room in the operating room department by face-to-face interview. Patients who accepted the study and met the criteria were included in the experimental/control group by randomization. In patients included in the experimental group; On the day of surgery, patients who met the research criteria were met, the purpose of the study was explained, and their written consent was obtained. The Patient Introduction Form and the Spielberg State-Trait Anxiety Scale were administered in the patient room using face-to-face interview technique. When the patient was taken to the operating table, the Vital Signs Record Form was filled out. Then, therapeutic touch was applied for 15-20 minutes during the surgery. After the procedure was completed, the Vital Signs Record Form, Spielberg State Anxiety Scale and Perianesthesia Comfort Scale (PCS) were administered. In patients included in the control group; On the day of surgery, patients who met the research criteria were met, the purpose of the study was explained, and their written consent was obtained. The Patient Introduction Form and the Spielberg State-Trait Anxiety Scale were administered in the patient room using face-to-face interview technique. When the patient was taken to the operating table, the Vital Signs Record Form was filled out. After the procedure is completed, the Vital Signs Record Form, Spielberg State Anxiety Scale and Perianesthesia Comfort Scale (PCS) will be administered. No procedure was applied to the control group. ### Conditions Module **Conditions:** - Intraoperative Complications **Keywords:** - therapeutic touch - anxiety - comfort ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 130 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will be administered an Introduction Form and Spielberg State-Trait Anxiety Scale before surgery. The Vital Signs Record Form will be filled out on the patient's operating table. Then, therapeutic touch will be applied for 15-20 minutes during the surgery. After the procedure, the Vital Signs Record Form, Spielberg State Anxiety Scale and Perianesthesia Comfort Scale (PCS) will be administered. **Intervention Names:** - Behavioral: Therapeutic Touch **Label:** There is therapeutic touch **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** An Introduction Form and the Spielberg State-Trait Anxiety Scale will be administered to the patients. When you are taken to the operating table, a Vital Signs Record Form will be filled out. After the procedure is completed, the Vital Signs Record Form, Spielberg State Anxiety Scale and Perianesthesia Comfort Scale (PCS) will be administered. **Label:** No therapeutic touch **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - There is therapeutic touch **Description:** Asymmetric energy fields can be balanced using the therapeutic touch method and treatment becomes easier. In this way, the person regains his health or can be helped to regain his health. **Name:** Therapeutic Touch **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The survey form, created by the researcher by scanning the literature on the subject, consists of a total of 13 questions including questions about gender, age, place of residence, education, status, profession, marital status, and total knee replacement surgery. **Measure:** Patient Introduction Form **Time Frame:** up to 24 weeks **Description:** An observation form was used to observe the patients in the experimental and control groups to whom therapeutic touch was applied during surgery. This form was used to record the duration of therapeutic touch, respiration, oxygen saturation, pulse, systolic blood pressure, and diastolic blood pressure. **Measure:** Vital Signs Record Form **Time Frame:** up to 24 weeks **Description:** There are 4 different options in the section that the individuals to whom the scale is applied will mark. These options consist of "not at all", "somewhat", "a lot" and "completely" in order to determine the intensity of the expressed behaviors and emotions. The total score obtained from both scales varies between 20-80. High scores indicate high anxiety levels, low scores indicate low anxiety levels. There are two types of statements in the State-Trait Anxiety Scale. Direct expressions express negative emotions, while inverted expressions express positive emotions. The reversed expressions in the State Anxiety Scale are items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20. The reversed expressions in the Trait Anxiety Scale constitute items 26, 27, 30, 33, 36 and 39. After finding the total weights of direct and reverse expressions separately, the total weight score of reverse expressions is subtracted from the total weight score obtained for direct expressions. **Measure:** Spielberg State-Trait Anxiety Scale **Time Frame:** Before and after surgery **Description:** The scale consists of 24 items that reflect the individual's general thought process before and after the surgical intervention and question his/her self-conception and feelings. Each statement in the scale has a Likert-type scoring ranging from 1 to 6, from "strongly disagree" to "strongly agree". The response patterns of the scale, which consists of positive and negative items, are given in mixed order. 12 of the statements are positive (1.5, 6, 11, 14, 16, 18, 19, 20, 21, 23, 24), 12 are negative (2, 3, 4, 7, 8, 9, 10, 12, 13, 15, 17, 22); Negative statements are reversed in scoring. Accordingly, in positive statements, a high score (6) indicates high comfort, a low score (1) indicates low comfort, and in negative items, a low score (1) indicates high comfort and a high score (6) indicates low comfort. **Measure:** Perianesthesia Comfort Scale (PCS) **Time Frame:** up to 24 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Being between the ages of 18-85 2. No communication problems (speaks Turkish) 3. No vision or hearing problems 4. No cognitive problems 5. The patient agrees to participate in the study 6. Having knee replacement surgery with local anesthesia Exclusion Criteria: 1. Being under the age of 18 and over the age of 85 2. Having a communication problem (does not speak Turkish) 3. The patient wants to leave the study 4. Not agreeing to participate in the research 5. Not being at a cognitive level to answer the questions asked. 6. Patients with vision and hearing problems 7. Having knee replacement surgery with general anesthesia **Healthy Volunteers:** True **Maximum Age:** 85 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ayşe ÇELİK **Phone:** 05417967629 **Role:** CONTACT #### Locations **Location 1:** **City:** Palandöken **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ayşe ÇELİK - **Phone:** 05417967629 - **Role:** CONTACT **Country:** Turkey **Facility:** Ayşe ÇELİK **State:** Erzurum **Status:** RECRUITING **Zip:** 25000 #### Overall Officials **Official 1:** **Affiliation:** Ataturk University **Name:** Dilek GÜRÇAYIR, Dr. **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M10465 - Name: Intraoperative Complications - Relevance: HIGH - As Found: Intraoperative Complications ### Condition Browse Module - Meshes - ID: D000007431 - Term: Intraoperative Complications ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426368 **Brief Title:** Soluble ST2 in Patients With Heart Failure" **Official Title:** " Prognostic Value of Soluble ST2 Beyond B-Type Natriuretic Peptide in Management of Patients With Heart Failure" #### Organization Study ID Info **ID:** ST2 in H.F patients #### Organization **Class:** OTHER **Full Name:** Assiut University ### Status Module #### Completion Date **Date:** 2027-01-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-12 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assiut University #### Responsible Party **Investigator Affiliation:** Assiut University **Investigator Full Name:** Dalia Mohamed Hesham Ahmed Mohamed **Investigator Title:** doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** 1. The aim of this study was to explore the relationship between peripheral circulating serum soluble suppression of tumorigenicity-2 (sST2) levels and inflammatory biomarkers in patients with heart failure 2. Additive role of sST2 to NPs in of heart failure patients **Detailed Description:** Heart failure (HF), a complex and heterogeneous medical syndrome characterized by structural and functional cardiac abnormalities and hemodynamic disruptions, represents the end-stage manifestation of numerous cardiovascular disorders . HF is categorized into three groups based on the measurement of the left ventricular (LV) ejection fraction (LVEF) according to the European Society of Cardiology (ESC) Guidelines issued in 2021: HF with reduced ejection fraction (HFrEF, LVEF ≤ 40%), HF with mildly reduced ejection fraction (HFmrEF, LVEF 41-49%), and HF with preserved ejection fraction (HFpEF, LVEF ≥ 50%) . Quantifying concentrations of circulating biomarkers plays a major role in most cardiovascular (CV) diseases, including (HF) . An ideal biomarker in HF should be measured non-invasively and at low cost, highly sensitive to allow for the early detection of the disease . N-terminal pro-B-type natriuretic peptide (NT-proBNP) released by cardiac muscle tissue in response to abnormal volume load is an established indicator for the diagnosis and prognosis of HF . However, there are important limitations to natriuretic peptide (NP) testing in HF . Soluble suppression of tumorigenicity-2 (sST2) is the circulating form of the interleukin-33 membrane receptor released in response to inflammation, fibrosis in various organs, and myocardium stress . Soluble (s)ST2 has been proposed as a useful biomarker for heart failure (HF) patient management. Myocardial damage or mechanical stress stimulate sST2 release. ST2 competes with a membrane bound receptor (ST2 ligand, or ST2L) for interleukin-33 (IL-33) binding, inhibiting the effects induced by the ST2L/IL-33 interaction so that excessive sST2 may contribute to myocardial fibrosis and ventricular remodelling. So biomarkers such as NT-proBNP and sST2 could potentially be used as surrogates for clinical outcomes in patients with HF and may be useful in monitoring disease progression and assessing the response to therapy . ### Conditions Module **Conditions:** - Heart Failure Patients ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** HF with reduced ejection fraction (HFrEF, LVEF ≤ 40%) **Intervention Names:** - Diagnostic Test: ST2 **Label:** Group I #### Arm Group 2 **Description:** HF with mildly reduced ejection fraction (HFmrEF, LVEF 41-49%) **Intervention Names:** - Diagnostic Test: ST2 **Label:** Group II #### Arm Group 3 **Description:** HF with preserved ejection fraction (HFpEF, LVEF ≥ 50%) **Intervention Names:** - Diagnostic Test: ST2 **Label:** Group III ### Interventions #### Intervention 1 **Arm Group Labels:** - Group I - Group II - Group III **Description:** ELISA used to detect levels of ST2 and BNP as inflammatory biomarkers in patients with heart failure **Name:** ST2 **Other Names:** - BNP **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Study ST2 level in heart failure patients and correlate results with clinical data and other inflammatory biomarker **Measure:** To evaluate if Soluble ST2 is strongly associated with measures of HF severity and poor outcome **Time Frame:** Baseline **Description:** Study value of BNP in prognosis and compare it with ST2 **Measure:** Evaluation of BNP and ST2 could have a potential role in prognosis. **Time Frame:** Baseline #### Secondary Outcomes **Description:** Evaluate ST2 as a novel biomarker which provide risk stratification of patients with acute and chronic HF beyond BNPs **Measure:** • Clinical Impact and Treatment Decision Support **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients 18-80 years. * Both sexes will be included. * including signs and symptoms of HF (e.g., elevated jugular venous pressure and altered apical beat position), altered LVEF (\< 40%; 40%-49%; ≥ 50%) Exclusion Criteria: * Patients \<18 years * Patients with documented evidence of cardiogenic shock . * Patients with Acute coronary syndrome within 30 days. * chronic kidney disease patients with glomerular filtration rate \< 30 * Patients with interstitial pulmonary fibrosis . **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study will be conducted at Chemistry unit of Clinical Pathology Department and Cardiovascular Department, Assiut University Hospitals, Assiut University, Egypt Heart failure patients will be classified according to NYHA classification ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Dalia Hesham **Phone:** 01149936172 **Role:** CONTACT **Contact 2:** **Name:** randa ahmed **Phone:** 01003390690 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Assiut University **Name:** Randa Ahmed **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Assiut University **Name:** Hanan Omer **Role:** STUDY_DIRECTOR **Official 3:** **Affiliation:** Assiut University **Name:** Yousra Mamdouh **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Purdy GE, Payne SM. The SHI-3 iron transport island of Shigella boydii 0-1392 carries the genes for aerobactin synthesis and transport. J Bacteriol. 2001 Jul;183(14):4176-82. doi: 10.1128/JB.183.14.4176-4182.2001. **PMID:** 11418557 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M9421 - Name: Heart Failure - Relevance: HIGH - As Found: Heart Failure - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006333 - Term: Heart Failure ### Intervention Browse Module - Browse Branches - Abbrev: NaAg - Name: Natriuretic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21935 - Name: Natriuretic Peptide, Brain - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426355 **Brief Title:** The Effeciency of NMN in Improving IVF/ICSI-ET Pregnancy Outcomes in Patients With DOR **Official Title:** The Effeciency of Nicotinamide Mononucleotide (NMN) in Improving IVF/ICSI-ET Pregnancy Outcomes in Patients With Decreased Ovarian Reserve（DOR): a Randomized Double-blind Placebo Control Clinical Trail #### Organization Study ID Info **ID:** M2023557 #### Organization **Class:** OTHER **Full Name:** Peking University Third Hospital ### Status Module #### Completion Date **Date:** 2027-02 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-02 **Type:** ESTIMATED #### Start Date **Date:** 2023-10-01 **Type:** ACTUAL **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-03-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Peking University Third 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:** The purpose of the study is to understand the effect of nicotinamide mononucleotide (NMN) on patients with diminished ovarian reserve and the outcomes of IVF/ICSI-ET. ### Conditions Module **Conditions:** - Diminished Ovarian Reserve ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Dietary Supplement: NMN intervention NMN capsules (total of 600mg/day) for 2-5 months **Intervention Names:** - Dietary Supplement: NMN **Label:** NMN intervention **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Placebo NMN-free placebo capsules for 2-5 months **Intervention Names:** - Other: Placebo **Label:** Placebo intervention **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - NMN intervention **Description:** NMN capsules (total of 600mg/day) for 2-5 months **Name:** NMN **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Placebo intervention **Description:** NMN-free placebo capsules for 2-5 months **Name:** Placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The pregnancy rate of IVF/ICSI-ET **Measure:** The clinical pregnancy rate **Time Frame:** through study completion, an average of 2 year #### Secondary Outcomes **Description:** Changes in endocrine hormones including AMH levels in serum after the intervention. **Measure:** Endocrine hormones including AMH **Time Frame:** Within three months after the end of treatment with NMN or placebo **Description:** The number of all antral follicles in each ovary will be determined using transvaginal ultrasonography for each participant. **Measure:** Follicle number **Time Frame:** Within three months after the end of treatment with NMN or placebo **Description:** Number of oocytes obtained, number of MII oocytes, fertilization rate, number of available embryos, number of high-quality embryos, cycle cancellation rate **Measure:** In vitro fertilization - outcome indicators of embryo culture **Time Frame:** Day of oocyte retrieval and 1 week after oocyte retrieval。Within three months after the end of treatment with NMN or placebo **Description:** Biochemical pregnancy rate **Measure:** Biochemical pregnancy rate **Time Frame:** after pregnancy and infant borned. Within 1 year after the end of treatment with NMN or placebo **Description:** live birth rate **Measure:** live birth rate **Time Frame:** after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo **Description:** abortion rate **Measure:** abortion rate **Time Frame:** after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo **Description:** pregnancy complications, the condition of newborn births **Measure:** pregnancy complications **Time Frame:** after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo **Description:** the condition of newborn births **Measure:** the condition of newborn births **Time Frame:** after pregnancy and infant borned.Within 1 year after the end of treatment with NMN or placebo **Description:** Intestinal flora and metabolite changes **Measure:** Metabolism-related index **Time Frame:** Within three months after the end of treatment with NMN or placebo **Description:** HOMA index **Measure:** Metabolism-related index **Time Frame:** Within three months after the end of treatment with NMN or placebo **Description:** waist-hip ratio **Measure:** Metabolism-related index **Time Frame:** Within three months after the end of treatment with NMN or placebo **Description:** BMI **Measure:** Metabolism-related index **Time Frame:** Within three months after the end of treatment with NMN or placebo ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Individuals who are 20 to 40 years old. 2. At least two of the following three conditions should be met: 1. The concentrations of anti-Mullerian hormone \< 1.1 ng/ml, 2. the values of antral follicle count was less than 7 3. serum concentrations of day-3 follicle-stimulating hormone (FSH)： 10 IU/L ≤ FSH\<20 IU/L 3. Individuals who can insist on continuous monitoring in the outpatient clinic. 4. Individuals who are not participating in other research projects currently or 3 months before the intervention. Exclusion Criteria: 1. Individuals who are during pregnant, lactation or menopause. 2. Individuals who had non-46-XX karyotype, or attributed to known genetic etiology. Individuals who had pelvic surgery. 3. Cancer patients or receiving chemo/radiotherapy treatment within the past 5 years. 4. Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc. 5. Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months. 6. Use of medications or traditional Chinese medicine that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 3 months. 7. Individuals who take niacin, nicotinamide, or other vitamin B3-related supplementation, or other supplementation such as coenzyme Q10, vitamin E currently or within the past 3 months. 8. Use of antibiotics, probiotics, or prebiotics that affect the flora within the past 3 months. 9. Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study. 10. A medical history of severe cardiovascular and cerebrovascular diseases. 11. Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption. 12. Individuals who drink more than 15g of alcohol per day or have a smoking habit. 13. Individuals who need drug treatment for any mental illness such as epilepsy and depression. 14. Individuals who suffer from infectious diseases such as hepatitis B, active tuberculosis, AIDS, etc. 15. Unable or unwilling to follow the study protocol. Individuals who are during pregnant, lactation or menopause. Individuals who had non-46-XX karyotype, or attributed to known genetic etiology. Individuals who had pelvic surgery. Cancer patients or receiving chemo/radiotherapy treatment within the past 5 years. Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc. Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months. Use of medications or traditional Chinese medicine that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 3 months. Individuals who take niacin, nicotinamide, or other vitamin B3-related supplementation, or other supplementation such as coenzyme Q10, vitamin E currently or within the past 3 months. Use of antibiotics, probiotics, or prebiotics that affect the flora within the past 3 months. Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study. A medical history of severe cardiovascular and cerebrovascular diseases. Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption. Individuals who drink more than 15g of alcohol per day or have a smoking habit. Individuals who need drug treatment for any mental illness such as epilepsy and depression. Individuals who suffer from infectious diseases such as hepatitis B, active tuberculosis, AIDS, etc. Unable or unwilling to follow the study protocol. - **Maximum Age:** 40 Years **Minimum Age:** 20 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Mengyu Liu, PhD **Phone:** 15611555481 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jie Qiao - **Phone:** 010-82265080 - **Role:** CONTACT **Country:** China **Facility:** Peking University Third Hospital **State:** Beijing **Status:** RECRUITING **Zip:** 100000 ### IPD Sharing Statement Module **Description:** Patients' information is requested to be confidential. **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: VaDiAg - Name: Vasodilator Agents - Abbrev: Lipd - Name: Lipid Regulating Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M12465 - Name: Niacin - Relevance: LOW - As Found: Unknown - ID: M12476 - Name: Niacinamide - Relevance: LOW - As Found: Unknown - ID: M12479 - Name: Nicotinic Acids - Relevance: LOW - As Found: Unknown - ID: T453 - Name: Niacin - Relevance: LOW - As Found: Unknown - ID: T455 - Name: Nicotinamide - Relevance: LOW - As Found: Unknown - ID: T454 - Name: Niacinamide - Relevance: LOW - As Found: Unknown - ID: T456 - Name: Nicotinic Acid - Relevance: LOW - As Found: Unknown - ID: T471 - Name: Vitamin B3 - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False