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## Protocol Section ### Identification Module **NCT ID:** NCT06431542 **Brief Title:** Efficacy of Self vs. Physician Application of Triamcinolone-Econazole in Otomycosis **Official Title:** Comparison of the Efficacy of Patient Self-Application Versus Physician Application of Triamcinolone Acetonide Econazole Cream in the Treatment of Otomycosis #### Organization Study ID Info **ID:** XMZSYYKY2024-047 #### Organization **Class:** OTHER **Full Name:** Zhongshan Hospital Xiamen University ### Status Module #### Completion Date **Date:** 2025-03 **Type:** ESTIMATED #### Expanded Access Info #### 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:** 2024-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **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:** Zhongshan Hospital Xiamen University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** to analyze the clinical characteristics, types of Fungal Infections, and comparison of the efficacy of patient self-application versus physician application of triamcinolone acetonide econazole cream in otomycosis treatment. **Detailed Description:** The study analyzes the clinical characteristics, including symptoms and physical examinations, as well as the types of fungal infections. It compares the efficacy of patient self-application versus physician application of triamcinolone acetonide econazole cream in treating otomycosis two weeks after starting treatment. Furthermore, the study also compares the recurrence rates six months after treatment. ### Conditions Module **Conditions:** - Otomycosis **Keywords:** - triamcinolone acetonide econazole cream - otomycosis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The doctor provided detailed instructions for the patient to self-apply Triamcinolone Acetonide Econazole Cream to the external auditory canal once daily for two weeks. **Intervention Names:** - Procedure: patient-applied Triamcinolone Acetonide Econazole Cream **Label:** patient-applied medication group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** The doctor applied Triamcinolone Acetonide Econazole Cream for patients once every 2 to 3 days, for a total of three applications. **Intervention Names:** - Procedure: physician-applied Triamcinolone Acetonide Econazole Cream **Label:** physician-applied medication group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - physician-applied medication group **Description:** The doctor applies the Triamcinolone Acetonide Econazole Cream onto a thin cotton swab and gently inserts it deep into the ear canal, evenly spreading the cream around the sides of the ear canal and on the surface of the eardrum. **Name:** physician-applied Triamcinolone Acetonide Econazole Cream **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - patient-applied medication group **Description:** The patient applies Triamcinolone Acetonide Econazole Cream in the external auditory canal at home using a cotton swab. **Name:** patient-applied Triamcinolone Acetonide Econazole Cream **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Treatment efficacy is defined as the proportion of patients who are effective after two weeks of treatment. Effectiveness is defined by the absence of abnormalities in the external auditory canal and the alleviation of symptoms. **Measure:** treatment efficacy **Time Frame:** 2 weeks #### Secondary Outcomes **Description:** Recurrence rate is assessed six months later during a follow-up examination, where the presence of abnormal secretions in the ear canal and the recurrence of symptoms are noted. **Measure:** recurrece rate **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 1.The chief complaint was ear discomfort, including tinnitus, a feeling of blockage or fullness, pruritis, otalgia, otorrhea and decreased hearing; 2. Physical examination findings:presence of fungal hyphae or accumulations that appear creamy or cheese-like or resembling abnormal earwax (crusts, films) , skin redness, erosion, swelling, or granulation tissue within the ear canal; 3. Positive results in fungal culture. Exclusion Criteria: * The exclusion criteria included otitis media, tympanic membrane perforation, and conditions post-radiotherapy. **Maximum Age:** 100 Years **Minimum Age:** 4 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Chunsheng Ye, MD **Phone:** +8613400661815 **Role:** CONTACT #### Locations **Location 1:** **City:** Xiamen **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Chunsheng Ye, MD - **Phone:** +8613400661815 - **Role:** CONTACT **Country:** China **Facility:** Xiamen University Zhongshan Hospital **State:** Fujian **Zip:** 361000 #### Overall Officials **Official 1:** **Affiliation:** Xiamen University Zhongshan Hospital **Name:** Chunsheng Chunsheng **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** The data will be open to peer-reviewed researchers. Researchers requesting access to the data must submit a research proposal and pass our review process. All data requestors must also adhere to a data use agreement. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** The data will be available within six months after the completion of the study and will remain accessible for at least ten years. **URL:** http://www.medresman.org ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009181 - Term: Mycoses - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000007239 - Term: Infections - ID: D000004427 - Term: Ear Diseases - ID: D000010038 - Term: Otorhinolaryngologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M29414 - Name: Otomycosis - Relevance: HIGH - As Found: Otomycosis - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - 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: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown - ID: M7601 - Name: Ear Diseases - Relevance: LOW - As Found: Unknown - ID: M12961 - Name: Otorhinolaryngologic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000059249 - Term: Otomycosis ### Intervention Browse Module - Ancestors - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000005938 - Term: Glucocorticoids - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000935 - Term: Antifungal Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000058888 - Term: 14-alpha Demethylase Inhibitors - ID: D000065607 - Term: Cytochrome P-450 Enzyme Inhibitors - ID: D000065088 - Term: Steroid Synthesis Inhibitors - ID: D000006727 - Term: Hormone Antagonists ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infl - Name: Anti-Inflammatory Agents ### Intervention Browse Module - Browse Leaves - ID: M7635 - Name: Econazole - Relevance: HIGH - As Found: Polymerase chain reaction (PCR) - ID: M16974 - Name: Triamcinolone - Relevance: HIGH - As Found: Calcium - ID: M16975 - Name: Triamcinolone Acetonide - Relevance: HIGH - As Found: Combination Therapy - ID: M237966 - Name: Triamcinolone hexacetonide - Relevance: HIGH - As Found: Combination Therapy - ID: M209573 - Name: Triamcinolone diacetate - Relevance: HIGH - As Found: Combination Therapy - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M9047 - Name: Glucocorticoids - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M6252 - Name: Clotrimazole - Relevance: LOW - As Found: Unknown - ID: M11796 - Name: Miconazole - Relevance: LOW - As Found: Unknown - ID: M4254 - Name: Antifungal Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M30537 - Name: Cytochrome P-450 Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000004464 - Term: Econazole - ID: D000014221 - Term: Triamcinolone - ID: D000014222 - Term: Triamcinolone Acetonide - ID: C000005900 - Term: Triamcinolone hexacetonide - ID: C000030262 - Term: Triamcinolone diacetate ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431529 **Acronym:** Neoantigen-T **Brief Title:** A Study of Tumor Neoantigen-specific T Cells in the Treatment of Advanced Solid Tumors **Official Title:** Exploratory Clinical Study of Tumor Neoantigen-specific T Cells in the Treatment of Advanced Solid Tumors #### Organization Study ID Info **ID:** SWZL20231008 #### Organization **Class:** OTHER **Full Name:** Jinling Hospital, China ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-03-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-18 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Nanjing University #### Lead Sponsor **Class:** OTHER **Name:** JIANG LONGWEI #### Responsible Party **Investigator Affiliation:** Jinling Hospital, China **Investigator Full Name:** JIANG LONGWEI **Investigator Title:** Associate Researcher **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 tumor neoantigen-specific T cells can treat patients with advanced solid tumors. The main questions it aims to answer are: Evaluate the safety of intravenous infusion of tumor neoantigen-specific T cells in the treatment of advanced solid tumors such as ovarian cancer, non-small cell lung cancer, and colorectal cancer. To evaluate the effectiveness of intravenous infusion of tumor neoantigen-specific T cells in the treatment of advanced solid tumors such as ovarian cancer, non-small cell lung cancer, and colorectal cancer and to study its immunological properties in patients. **Detailed Description:** In this open, single-armed study, selected patients with advanced solid tumor confirmed by Histopathology will be received tumor neoantigen specific T cells treatment. First, their tumor specimen will be collected from surgery or puncture，then their PBMC will be separated by blood cell separator. This cells will be cultured and selected in GMP laboratory to make tumor neoantigen specific T cells. The tumor neoantigen specific T cells will be infused intravenous into patients. ### Conditions Module **Conditions:** - Tumor, Solid **Keywords:** - Solid tumor; T cell; neoantigen ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 6 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Tumor neoantigen specific T cells will be infused intravenously into patients. The number of T cells will be more than 1.0E9. **Intervention Names:** - Biological: tumor neoantigen specific T cell **Label:** tumor neoantigen specific T cell **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - tumor neoantigen specific T cell **Description:** Isolate the patient's autologous monocytes, induce and culture them into tumor antigen presenting cells in vitro, and then phagocytose tumor tissue cells obtained from biopsy or surgery to present tumor neoantigens to autologous T cells. The final product For tumor neoantigen specific T cells (NeoT). **Name:** tumor neoantigen specific T cell **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** The adverse events and severe adverse events will be evaluated. **Measure:** Evaluate the safety of tumor neoantigen specific T cells in the treatment of advanced tumor patients **Time Frame:** 2 years #### Secondary Outcomes **Description:** The objective clinical response will be evaluated. **Measure:** Evaluate the efficiency of tumor neoantigen specific T cells in the treatment of advanced solid tumor. **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age 18-75 years old; 2. Patients with solid malignant tumors confirmed by histology or cytology such as ovarian cancer, non-small cell lung cancer or colorectal cancer; 3. Cancer patients who have failed previous standard treatments or who have refused subsequent chemotherapy and whose expected survival time exceeds 3 months; 4. ECOG: 0-2 points; 5. Patients of childbearing age need to take appropriate protective measures (contraceptive measures or other birth control methods) before enrollment and during the experiment; 6. Those who can understand this trial and have signed the informed consent form; 7. Able to follow the research protocol and follow-up procedures Exclusion Criteria: 1. Those who have received any form of immunotherapy within the past 3 months; 2. Those who need to use immunosuppressants; 3. Those who have received anti-tumor treatment such as tumor chemotherapy, radiotherapy, and secondary and above surgery within the past month; 4. Those who have a history of other tumors in the past, unless it is cervical cancer in situ, treated squamous cell carcinoma or bladder epithelial tumor (Ta and TIS), or other malignant tumors that have received radical treatment (at least 5 years before enrollment) ); 5. White blood cell count \<3E9/L, platelet count \<80E9/L; 6. AST and ALT\>3×the upper limit of normal (ULN), total bilirubin\>2×ULN, and AST and ALT\>6×ULN in patients with liver metastasis; 7. Creatinine clearance \<60ml/min; 8. Abnormal coagulation function; 9. The patient has active bacterial or fungal infection (≥Grade 2 of NCI-CTC, third edition); 10. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) is positive and the peripheral blood hepatitis B virus (HBV) DNA detection value is \>100 IU/mL; hepatitis C virus (HCV) antibody is positive and the peripheral blood hepatitis C Those who are positive for hepatitis virus (HCV) RNA; those who are positive for human immunodeficiency virus (HIV) antibodies; those who are positive for cytomegalovirus (CMV) DNA; those who are positive for syphilis; 11. Diseases judged by the researcher to be ineligible for inclusion: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment, uncontrollable coronary artery disease or asthma, and uncontrollable cerebrovascular disease. 12. Women who are pregnant or breastfeeding, and women of childbearing age must have a negative pregnancy test within 7 days before enrollment; 13. Substance abuse, clinical or psychological or social factors that affect informed consent or research implementation; 14. Those who may be allergic to study drugs; 15. Participate in other clinical trials one month before registration; 16. Patients who cannot undergo mononuclear cell separation or whose peripheral venous access cannot be opened; 17. Any uncertain factors that affect patient safety or compliance; 18. Other researchers believe that the subject is not suitable for inclusion. **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:** Jiang Longwei, Master **Phone:** +86-02580864524 **Role:** CONTACT #### Locations **Location 1:** **City:** Nanjing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jiang Longwei, Master - **Phone:** +86-02580864524 - **Role:** CONTACT ***Contact 2:*** - **Name:** Jia Shaochang, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Zen Ke, PhD - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Liu Yuan, PhD - **Role:** SUB_INVESTIGATOR ***Contact 5:*** - **Name:** Jiang Longwei, Master - **Role:** SUB_INVESTIGATOR **Country:** China **Facility:** Nanjing Jinling Hospital **State:** Jiangsu **Status:** RECRUITING **Zip:** 210002 #### Overall Officials **Official 1:** **Affiliation:** Jinling Hospital, China **Name:** Jia Shaochang, MD **Role:** STUDY_DIRECTOR ### 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:** NCT06431516 **Brief Title:** LMCA Treatment Outcome **Official Title:** Clinical Outcomes of Medical Treatment for Patients With Significant Unprotected Left Main Coronary Artery Disease #### Organization Study ID Info **ID:** 2023.230 #### Organization **Class:** OTHER **Full Name:** Chinese University of Hong Kong ### Status Module #### Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-09-11 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Chinese University of Hong Kong #### Responsible Party **Investigator Affiliation:** Chinese University of Hong Kong **Investigator Full Name:** GuangMing Tan **Investigator Title:** Assistant professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Left main coronary artery (LMCA) is a major branch of coronary artery and supplies a large bulk of myocardium. Revascularization by either surgical coronary bypass grafting (CABG) or percutaneous coronary intervention (PCI) is recommended for significant unprotected LMCA disease, with CABG being preferred if there is significant involvement in other coronary arteries1,2. CABG has been demonstrated to confer survival benefit over medical therapies patients with LMCA in earlier clinical trials3,4,5. However, these trials were performed before the wide adoption of modern medical therapies such as antiplatelet and statin. Antiplatelet agents, for example, was only used in 32% of all patients in the Coronary Artery Surgery Study3. Modern day medical treatment for stable coronary artery diseases have been shown to be non-inferior to revascularization in both the COURAGE and ISCHEMIA trials6,7. However, patients with LMCA involvement were mostly excluded from both of these studies. In Hong Kong, the average waiting time for an elective CABG for stable patients with LMCA is around 18 months, during which time the patients are treated with modern medical therapies including high-intensity statin and antiplatelet. **Detailed Description:** Left main coronary artery (LMCA) is a major branch of coronary artery and supplies a large bulk of myocardium. Revascularization by either surgical coronary bypass grafting (CABG) or percutaneous coronary intervention (PCI) is recommended for significant unprotected LMCA disease, with CABG being preferred if there is significant involvement in other coronary arteries1,2. CABG has been demonstrated to confer survival benefit over medical therapies patients with LMCA in earlier clinical trials3,4,5. However, these trials were performed before the wide adoption of modern medical therapies such as antiplatelet and statin. Antiplatelet agents, for example, was only used in 32% of all patients in the Coronary Artery Surgery Study3. Modern day medical treatment for stable coronary artery diseases have been shown to be non-inferior to revascularization in both the COURAGE and ISCHEMIA trials6,7. However, patients with LMCA involvement were mostly excluded from both of these studies. In Hong Kong, the average waiting time for an elective CABG for stable patients with LMCA is around 18 months, during which time the patients are treated with modern medical therapies including high-intensity statin and antiplatelet. ### Conditions Module **Conditions:** - Left Main Coronary Artery ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 4600 **Type:** ACTUAL **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Year ### Arms Interventions Module #### Arm Group 1 **Label:** Patients with significant LMCA disease #### Arm Group 2 **Label:** normal patient ### Outcomes Module #### Primary Outcomes **Description:** Major adverse cardiac and cerebrovascular events (MACCE) which is defined as a composite of death of any cause, myocardial infarction (MI), stroke, or urgent revascularization **Measure:** Major adverse cardiac and cerebrovascular events (MACCE) which is defined as a composite of death of any cause, myocardial infarction (MI), stroke, or urgent revascularization **Time Frame:** 1 year **Description:** Death of any cause. **Measure:** Death of any cause. **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with significant LMCA disease who were on the waitlist for CABG since 1st January 2000 to 31st December 2020. * The decision for CABG over PCI as a mode of revascularization for the patients on this waitlist were collectively made by the HEART team Exclusion Criteria: * patients with co-existing significant valvular heart disease requiring concomitant surgical intervention, and unstable patients in whom urgent surgical intervention was performed **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Categorical variables will be presented as numbers and percentages and continuous data as mean and standard deviation. Kaplan-Meier survival curve will be obtained using time to event analysis will be performed for this study, with the time of CABG referral counted as day 0 and the day of CABG counted as the end of follow-up. Multivariate Cox regression analysis will be conducted to delineate the predictors for primary outcomes. Potential implications of this study This study will inform us about the mid-term clinical outcomes of modern-day medical therapy in patients with significant LMCA disease. Potential predictors of adverse outcome could be identified through regression analysis. This might help us to identify and expedite CABG arrangement for patients with these risk factors. ### Contacts Locations Module #### Locations **Location 1:** **City:** Hong Kong **Country:** Hong Kong **Facility:** Prince of Wales Hospital **State:** Shatin **Zip:** 0000 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6546 - Name: Coronary Artery Disease - Relevance: LOW - As Found: Unknown - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown - ID: M6549 - Name: Coronary Disease - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431503 **Brief Title:** Effect of Tok-Sen Massage for Non-specific Low Back Pain **Official Title:** Effect of Tok-Sen Massage for Non-specific Low Back Pain #### Organization Study ID Info **ID:** CMUH112-REC1-132 #### Organization **Class:** OTHER **Full Name:** China Medical University Hospital ### 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:** 2024-05-22 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2023-11-11 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** China Medical University Hospital #### 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 purpose of this clinical trial was to find out whether Tok Sen massage (a massage method with wooden instruments from northern Thailand) is more effective than pressure massage in relieving pain and improving quality of life in participants with chronic low back pain. The main questions it aims to answer are: Can Tok Sen Massage Relieve Chronic Lower Back Pain? Can Tok Sen massage improve the quality of life of patients with chronic low back pain? Researchers compared Tok Sen massage with pressure massage, which works on low back pain, to see if it could treat chronic low back pain. Participants will: Receive Tok Sen massage or pressure massage every week for 1 month. Questionnaires and flexion measurements before and after each massage. After the massage session, fill out the online questionnaire once a month for three months. **Detailed Description:** Low back pain is the world's leading cause of global productivity loss and the leading cause of years lost with disability (YLDs), with a high prevalence of 28%-42% among those aged 40 to 69 years. The prevalence of different occupations in Taiwan ranges from 35% to 90%; according to the summary of the National Health Insurance Database results report: "The annual prevalence of low back pain is 14% to 45%, and 70% to 85% of people in their lifetime Suffering from low back pain. "Most people who experience low back pain cannot identify the specific source of the injury, and up to 90% of low back pain is non-specific. Approximately 85% of patients with low back pain cannot obtain accurate pathological anatomy diagnosis. Tok-Sen Massage is a kind of folk therapy in northern Thailand, specializing in musculoskeletal system diseases. This trial selected Pressure Massage as an active control for evaluating the effectiveness of two massage methods in improving low back pain. This is an open-label and randomized controlled trial. Patients aged 20-69 years old with non-specific chronic low back pain were randomized divided into two different groups. 7 people in the Tok-Sen Massage group received a 40-minute intervention once a week for a total of 4 times, and 7 people the Pressure Massage group received a 40-minute intervention once a week for a total of 4 times. Massage area are on the bladder meridian on the back and the spleen, liver and kidney meridian of the lower limbs. The evaluation methods are: 1. Oswestry Disability Index (ODI) (baseline and after three interventions), 2. Visual Analogue Scale (VAS)before and after each massage, 3. Trunk flexibility test. before and after each massage. ### Conditions Module **Conditions:** - Non-specific Chronic Low Back Pain **Keywords:** - Tok-Sne massage - pressure massage - low back pain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 14 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Tok-Sen massage uses a mallet to hit a wooden wedge to produce impact and sound. **Intervention Names:** - Other: Tok-Sen Massage **Label:** Tok-Sen massage **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Pressure massage uses the wooden wedge to press. **Intervention Names:** - Other: Pressure Massage **Label:** Pressure massage **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Tok-Sen massage **Description:** Press the wedge and tapping: the strength for pressing the wadge is 1000g±50g, the height for mallet free fall(instead of beating by arm)10cm±2cm. For Pressure massage, the strength for pressing the wadge is 1500g±50g. **Name:** Tok-Sen Massage **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Pressure massage **Description:** Press the wedge: the strength for pressing the wadge is 1500g±50g, **Name:** Pressure Massage **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Improvement in ODI score **Measure:** Improve the disability of low back pain **Time Frame:** From enrollment to the end of follow up at 4 months #### Secondary Outcomes **Description:** Improvement of VAS score **Measure:** Pain relieving **Time Frame:** From enrollment to the end of 4 times treatments at 4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * chronic low back pain for more than 3 months * diagnosis of non-specific low back pain Exclusion Criteria: - * Spinal surgery history * Joint disease * Pregnancy * Cancer * Systemic disease * Mental disease * Bone Mass Measurement less than **Maximum Age:** 69 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Taichung City **Country:** Taiwan **Facility:** China Medical University Hospital **State:** North Dist **Zip:** 404 #### Overall Officials **Official 1:** **Affiliation:** China Medical University, China **Name:** Yu-Chen Lee, M.D. & Ph.D. **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Snook SH. Self-care guidelines for the management of nonspecific low back pain. J Occup Rehabil. 2004 Dec;14(4):243-53. doi: 10.1023/b:joor.0000047427.21710.07. **PMID:** 15638255 **Citation:** Farooque M. Specific and nonspecific low back pain-mind the gap and its impact in clinical practice: opinion of a recovering interventional spine physiatrist. Spine J. 2023 Aug;23(8):1101-1107. doi: 10.1016/j.spinee.2023.04.011. Epub 2023 Apr 27. No abstract available. **PMID:** 37116719 **Citation:** Knezevic NN, Candido KD, Vlaeyen JWS, Van Zundert J, Cohen SP. Low back pain. Lancet. 2021 Jul 3;398(10294):78-92. doi: 10.1016/S0140-6736(21)00733-9. Epub 2021 Jun 8. **PMID:** 34115979 **Citation:** Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017. **PMID:** 11074683 **Citation:** Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11. **PMID:** 27745712 **Citation:** Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6. **PMID:** 21982256 **Citation:** Chenot JF, Greitemann B, Kladny B, Petzke F, Pfingsten M, Schorr SG. Non-Specific Low Back Pain. Dtsch Arztebl Int. 2017 Dec 25;114(51-52):883-890. doi: 10.3238/arztebl.2017.0883. **PMID:** 29321099 **Citation:** Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14. **PMID:** 28192789 **Citation:** GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8. Erratum In: Lancet. 2019 Jun 22;393(10190):e44. **PMID:** 30496104 **Citation:** Merritt JL, McLean TJ, Erickson RP, Offord KP. Measurement of trunk flexibility in normal subjects: reproducibility of three clinical methods. Mayo Clin Proc. 1986 Mar;61(3):192-7. doi: 10.1016/s0025-6196(12)61848-5. **PMID:** 3945120 **Citation:** Chen S, Chen M, Wu X, Lin S, Tao C, Cao H, Shao Z, Xiao G. Global, regional and national burden of low back pain 1990-2019: A systematic analysis of the Global Burden of Disease study 2019. J Orthop Translat. 2021 Sep 10;32:49-58. doi: 10.1016/j.jot.2021.07.005. eCollection 2022 Jan. **PMID:** 34934626 **Citation:** Raja SN, Carr DB, Cohen M, Finnerup NB, Flor H, Gibson S, Keefe FJ, Mogil JS, Ringkamp M, Sluka KA, Song XJ, Stevens B, Sullivan MD, Tutelman PR, Ushida T, Vader K. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. Pain. 2020 Sep 1;161(9):1976-1982. doi: 10.1097/j.pain.0000000000001939. **PMID:** 32694387 **Citation:** Shafshak TS, Elnemr R. The Visual Analogue Scale Versus Numerical Rating Scale in Measuring Pain Severity and Predicting Disability in Low Back Pain. J Clin Rheumatol. 2021 Oct 1;27(7):282-285. doi: 10.1097/RHU.0000000000001320. **PMID:** 31985722 **Citation:** Klineberg E, Mazanec D, Orr D, Demicco R, Bell G, McLain R. Masquerade: medical causes of back pain. Cleve Clin J Med. 2007 Dec;74(12):905-13. doi: 10.3949/ccjm.74.12.905. **PMID:** 18183841 **Citation:** Meucci RD, Fassa AG, Faria NM. Prevalence of chronic low back pain: systematic review. Rev Saude Publica. 2015;49:1. doi: 10.1590/S0034-8910.2015049005874. Epub 2015 Oct 20. **PMID:** 26487293 **Citation:** Foster NE, Anema JR, Cherkin D, Chou R, Cohen SP, Gross DP, Ferreira PH, Fritz JM, Koes BW, Peul W, Turner JA, Maher CG; Lancet Low Back Pain Series Working Group. Prevention and treatment of low back pain: evidence, challenges, and promising directions. Lancet. 2018 Jun 9;391(10137):2368-2383. doi: 10.1016/S0140-6736(18)30489-6. Epub 2018 Mar 21. **PMID:** 29573872 **Citation:** Langevin HM, Sherman KJ. Pathophysiological model for chronic low back pain integrating connective tissue and nervous system mechanisms. Med Hypotheses. 2007;68(1):74-80. doi: 10.1016/j.mehy.2006.06.033. Epub 2006 Aug 21. **PMID:** 16919887 **Citation:** Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21. **PMID:** 29573870 **Citation:** Traeger AC, Buchbinder R, Elshaug AG, Croft PR, Maher CG. Care for low back pain: can health systems deliver? Bull World Health Organ. 2019 Jun 1;97(6):423-433. doi: 10.2471/BLT.18.226050. Epub 2019 Apr 30. **PMID:** 31210680 ## 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: 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 - ID: T1303 - Name: Chronic Graft Versus Host Disease - 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:** NCT06431490 **Brief Title:** A Study of TQB2102 for Injection in the Treatment of HER2-positive Biliary Tract Cancer **Official Title:** A Study to Evaluate the Efficacy, Safety, and Immunogenicity of TQB2102 for Injection in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer #### Organization Study ID Info **ID:** TQB2102-Ib/II-01 #### Organization **Class:** INDUSTRY **Full Name:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** To evaluate the efficacy and safety TQB2102 for injection in the treatment of patients with Her2-positive biliary tract cancer. ### Conditions Module **Conditions:** - Biliary Tract Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 103 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, 6/8 cycles. **Intervention Names:** - Drug: TQB2102 for injection **Label:** TQB2102 for injection **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - TQB2102 for injection **Description:** TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC) **Name:** TQB2102 for injection **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Any adverse medical event that occurred from the time the subject signed the informed consent until 28 days after the last dose/start of the new antitumor therapy (whichever came first). **Measure:** Incidence and severity of adverse events (AE) and serious adverse events (SAE) **Time Frame:** From the time the subject signed the informed consent until 28 days after the last dose/start of the new antitumor therapy **Description:** Phase II Recommended Dose (RP2D) **Measure:** Phase II Recommended Dose (RP2D) **Time Frame:** Baseline up to 24 weeks #### Secondary Outcomes **Description:** The percentage of subjects achieving complete response (CR) or partial response (PR) as assessed by the investigator based on the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. **Measure:** Objective response rate (ORR) **Time Frame:** Baseline up to 36 weeks **Description:** The time between first medication and first disease progression or death from any cause. **Measure:** Progression-free survival (PFS) **Time Frame:** Baseline up to 36 weeks **Description:** The first assessment was complete response, partial response, and time to disease stabilization. **Measure:** Disease control rate (DCR) **Time Frame:** Baseline up to 36 weeks **Description:** First assessed as complete or partial response to first disease progression or time of death from all causes. **Measure:** Disease response time (DOR) **Time Frame:** Baseline up to 36 weeks **Description:** Time from first use to death from any cause **Measure:** Overall survival (OS) **Time Frame:** Baseline up to 36 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18 years ≤ age ≤75 years; Eastern Cooperative Oncology Group (ECOG) score 0 to 1; * Test subjects with HER2 expression or amplification or mutation require immunohistochemistry of HER2 3+ or HER2 2 and positive for in situ hybridization (ISH); * The main organs function well; * Meet the criteria for advanced biliary tract cancer: 1. Biliary tract carcinoma confirmed by histology or cytology; 2. Non-operable locally advanced, recurrent and/or metastatic disease with at least one measurable lesion according to Evaluation criteria for the efficacy of solid tumors (RECIST) 1.1 criteria; 3. Failure of previous standard treatment. * Women of reproductive age should agree that effective contraception must be used during the study period and for 6 months after the end of the study, and that serum or urine pregnancy tests are negative within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for 6 months after the end of the study period; * The subjects voluntarily joined the study, signed the informed consent, and the compliance was good. Exclusion Criteria: * Complicated diseases and medical history: 1. Have had or are currently suffering from other malignant tumors within 3 years before the first medication; 2. Unmitigated toxic effects higher than grade 1 of Common Terminology Criteria for Adverse Events (CTCAE) due to any previous treatment; 3. Major surgical treatment, significant traumatic injury, or long-term unhealed wounds or fractures have been received within 4 weeks prior to initial medication; 4. Patients with any bleeding or bleeding events ≥CTCAE grade 3 within 4 weeks before the first dose; Aortic/venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism, occurred within 6 months prior to initial administration; Treatment with low molecular weight heparin was permitted and antiplatelet drugs were prohibited throughout the study period; 5. Active viral hepatitis with poor control; 6. There is a history of active tuberculosis, idiopathic pulmonary fibrosis, institutional pneumonia, drug-induced pneumonia, radiation pneumonia requiring treatment or active pneumonia with clinical symptoms; 7. Have a history of psychotropic drug abuse and can not quit or have mental disorders; 8. People who are ready to undergo or have previously received allogeneic bone marrow transplantation or solid organ transplantation; 9. Have a history of hepatic encephalopathy; 10. Currently on or recently used (within 7 days before the start of study treatment) aspirin (\>325 mg/ day (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel, and cilostazol; 11. Subjects with any severe and/or uncontrolled disease. * Tumor related and treatment: 1. For subjects who have received chemotherapy, immunotherapy within 3 weeks before the first dose, radiation therapy or small molecule targeted drugs within 2 weeks, or who are still within the 5 half-lives of the drug (as the shortest time of occurrence), the washout period is calculated from the end time of the last treatment; 2. Within 2 weeks before the first use of the drug, the treatment of Chinese patent drugs with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions; 3. Imaging including computed tomography (CT) or magnetic resonance imaging (MRI) shows that the tumor has invaded important blood vessels, or the investigator determines that the tumor is highly likely to invade important blood vessels during the follow-up study period and cause fatal massive bleeding; 4. Uncontrolled pleural effusion, pericardial effusion or moderate to severe ascites that still require repeated drainage; 5. Obvious biliary obstruction (except for total bilirubin ≤ 2× upper limit of normal (ULN) after endoscopic stent placement and percutaneous transhepatic biliary drainage); 6. Known spinal cord compression, cancerous meningitis, with symptoms of brain metastases, or symptoms controlled for less than 4 weeks. * Research treatment related: 1. Known allergy to study drug excipients; 2. Have previously received anti-HER2 therapy drugs (only for the second stage, the first stage is not limited); 3. Patients who require immunosuppressive, systemic, or absorbable topical hormone therapy for immunosuppressive purposes and who continue to use it for 7 days prior to initial administration (except for corticosteroids \<10 mg per day of prednisone or other therapeutic hormones). 4. Participants who participated in and used other anti-tumor clinical trials within 4 weeks before the first medication. 5. According to the judgment of the researcher, there is a situation that seriously endangers the safety of the subjects or affects the completion of the study. **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:** Feng Shen, Doctor **Phone:** 13901651428 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Jun Zhou, Doctor **Phone:** 13366152815 **Role:** CONTACT #### Locations **Location 1:** **City:** Fuyang **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Hesheng Qian, Bachelor - **Phone:** 13956814015 - **Role:** CONTACT **Country:** China **Facility:** Fuyang Cancer Hospital **State:** Anhui **Zip:** 236010 **Location 2:** **City:** Hefei **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Zhanggui Wang, Doctor - **Phone:** 13637095096 - **Role:** CONTACT **Country:** China **Facility:** Anhui Second People's Hospital **State:** Anhui **Zip:** 230012 **Location 3:** **City:** Hefei **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yifu He, Doctor - **Phone:** 18963789042 - **Role:** CONTACT **Country:** China **Facility:** Anhui Provincial Cancer Hospital **State:** Anhui **Zip:** 230031 **Location 4:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yongkun Sun, Doctor - **Phone:** 13141276041 - **Role:** CONTACT **Country:** China **Facility:** Cancer Hospital Chinese Academy of Medical Science **State:** Beijing **Zip:** 100021 **Location 5:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jun Zhou, Doctor - **Phone:** 13366152815 - **Role:** CONTACT **Country:** China **Facility:** Beijing Cancer Hospital **State:** Beijing **Zip:** 100089 **Location 6:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ming Yang, Doctor - **Phone:** 15810092973 - **Role:** CONTACT **Country:** China **Facility:** Tsinghua Changgeng Hospital, Beijing **State:** Beijing **Zip:** 100089 **Location 7:** **City:** Guangzhou **Country:** China **Facility:** Sun Yat-sen University Cancer Center **State:** Guangdong **Zip:** 510062 **Location 8:** **City:** Jiangmen **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Gengsheng Yu, Doctor - **Phone:** 13828077428 - **Role:** CONTACT **Country:** China **Facility:** Jiangmen Central Hospital **State:** Guangdong **Zip:** 529000 **Location 9:** **City:** Tangshan **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Zhiwu Wang, Doctor - **Phone:** 18931506162 - **Role:** CONTACT **Country:** China **Facility:** Tangshan People's Hospital **State:** Hebei **Zip:** 063000 **Location 10:** **City:** Harbin **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Zhiwei Li - **Phone:** 15004683651 - **Role:** CONTACT **Country:** China **Facility:** Harbin Medical University Cancer Hospital **State:** Heilongjiang **Zip:** 150081 **Location 11:** **City:** Zhengzhou **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** YanRu Qin, Doctor - **Phone:** 13676932999 - **Role:** CONTACT **Country:** China **Facility:** The First Affiliated Hospital of Zhengzhou University **State:** Henan **Zip:** 450000 **Location 12:** **City:** Wuhan **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Hong Ma, Doctor - **Phone:** 13377876066 - **Role:** CONTACT **Country:** China **Facility:** Huazhong University of Science and Technology **State:** Hubei **Zip:** 430023 **Location 13:** **City:** Wuhan **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Fuxiang Zhou, Doctor - **Phone:** 18971252780 - **Role:** CONTACT **Country:** China **Facility:** Wuhan University Zhongnan Hospital **State:** Hubei **Zip:** 430071 **Location 14:** **City:** Changsha **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jia Luo, Doctor - **Phone:** 13874994359 - **Role:** CONTACT **Country:** China **Facility:** Hunan Cancer Hospital **State:** Hunan **Zip:** 410031 **Location 15:** **City:** Nanjing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Xiaofeng Chen, Doctor - **Phone:** 13585172066 - **Role:** CONTACT **Country:** China **Facility:** Jiangsu Provincial People's Hospital **State:** Jiangsu **Zip:** 210000 **Location 16:** **City:** Yancheng **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Qi Li, Doctor - **Phone:** 13818207333 - **Role:** CONTACT **Country:** China **Facility:** Dongtai People'S Hospital **State:** Jiangsu **Zip:** 224200 **Location 17:** **City:** Changchun **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ying Cheng, Doctor - **Phone:** 0431-85871902 - **Role:** CONTACT **Country:** China **Facility:** Jilin Cancer Hospital **State:** Jilin **Zip:** 130012 **Location 18:** **City:** Chifeng **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Zhonghua Liu, Doctor - **Phone:** 18604769266 - **Role:** CONTACT **Country:** China **Facility:** Chifeng City Hospital **State:** Neimengu **Zip:** 024000 **Location 19:** **City:** Xi'an **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Aili Suo, Doctor - **Phone:** 18991232561 - **Role:** CONTACT **Country:** China **Facility:** The First Affiliated Hospital of Xi'an Jiaotong University **State:** Shaanxi **Zip:** 710000 **Location 20:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Feng Shen, Doctor - **Phone:** 13901651428 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Leilei Bao, Doctor - **Phone:** 021-81875571 - **Role:** CONTACT **Country:** China **Facility:** The Third Affiliated Hospital of PLA Navy Medical University **State:** Shanghai **Zip:** 200433 **Location 21:** **City:** Taiyuan **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yusheng Wang, Doctor - **Phone:** 13834646436 - **Role:** CONTACT **Country:** China **Facility:** First Hospital of Shangxi Medical University **State:** Shanxi **Zip:** 030001 **Location 22:** **City:** Tianjin **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Hongli Li, Doctor - **Phone:** 18622221233 - **Role:** CONTACT **Country:** China **Facility:** Tianjin Cancer Hospital **State:** Tianjin **Zip:** 300000 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001660 - Term: Biliary Tract Diseases - ID: D000004066 - Term: Digestive System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4947 - Name: Biliary Tract Neoplasms - Relevance: HIGH - As Found: Biliary Tract Cancer - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - 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: T761 - Name: Biliary Tract Cancer - Relevance: HIGH - As Found: Biliary Tract Cancer ### Condition Browse Module - Meshes - ID: D000001661 - Term: Biliary Tract Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431477 **Brief Title:** Efficacy and Safety of Telmisartan Compared With Losartan **Official Title:** A Multi-center, Randomized, Open-label, Active Comparator-controlled, Phase 4 Clinical Trial To Evaluate the Efficacy and Safety of Telmisartan Compared With Losartan in Patients With Diabetic Nephropathy and Hypertension #### Organization Study ID Info **ID:** B115_02HT/DN2201 #### Organization **Class:** INDUSTRY **Full Name:** Chong Kun Dang Pharmaceutical ### Status Module #### Completion Date **Date:** 2025-10-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-10-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-04-19 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Chong Kun Dang Pharmaceutical #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** A study to evaluate the efficacy and safety of telmisartan compared with losartan in patients with diabetic nephropathy and hypertension **Detailed Description:** A Multi-center, Randomized, Open-label, Active comparator-controlled, Phase 4 Clinical Trial To Evaluate the Efficacy and Safety of Telmisartan Compared with Losartan in Patients with Diabetic Nephropathy and Hypertension ### Conditions Module **Conditions:** - Diabetic Nephropathies - Hypertension ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 98 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: telmisartan **Label:** Telmisartan tablet **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Losartan **Label:** Losartan tablet **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Telmisartan tablet **Description:** QD, PO **Name:** telmisartan **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Losartan tablet **Description:** QD, PO **Name:** Losartan **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Change rate from baseline in Spot-UACR(Albumin/Creatinine Ratio) **Time Frame:** 24 weeks after drug administration ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male of Female subjects aged ≥19 or \<75 * Type II Diabetes Mellitus subjects who have been taken medicine * Subjects who have voluntarily decided to participate in this clinical trial and Signed ICF Exclusion Criteria: * Subjects with Type I Diabetes Mellitus * Subjects with Primary hyper-aldosteronism * Subjects with a history of drug or alcohol abuse or suspected patient within 1 year as of the time of screening * Pregnant women, lactating women, or subjects who do not agree to use appropriate contraception during the clinical trial period * Subjects who received other clinical trial drugs within 28 days of screening visit * Subjects who are unable to participate in this clinical trial at the discretion of the investigator. **Maximum Age:** 75 Years **Minimum Age:** 19 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** BeomSeok Kim, M.D, Ph.D **Phone:** +82-2-2228-5331 **Role:** CONTACT #### Locations **Location 1:** **City:** Seoul **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** BeomSeok Kim, M.D, Ph.D - **Phone:** +02-2228-5331 - **Role:** CONTACT **Country:** Korea, Republic of **Facility:** Severance Hospital **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Severance Hospital **Name:** BeomSeok Kim, M.D, Ph.D **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000048909 - Term: Diabetes Complications - ID: D000003920 - Term: Diabetes Mellitus - ID: D000004700 - Term: Endocrine System 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: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: HIGH - As Found: Nephropathy - ID: M10024 - Name: Hypertension - Relevance: HIGH - As Found: Hypertension - ID: M7123 - Name: Diabetic Nephropathies - Relevance: HIGH - As Found: Diabetic Nephropathy - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M26004 - Name: Diabetes Complications - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007674 - Term: Kidney Diseases - ID: D000003928 - Term: Diabetic Nephropathies - ID: D000006973 - Term: Hypertension ### Intervention Browse Module - Ancestors - ID: D000000889 - Term: Anti-Arrhythmia Agents - ID: D000000959 - Term: Antihypertensive Agents - ID: D000047228 - Term: Angiotensin II Type 1 Receptor Blockers - ID: D000057911 - Term: Angiotensin Receptor Antagonists - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: AnAg - Name: Antihypertensive Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: VaCoAg - Name: Vasoconstrictor Agents ### Intervention Browse Module - Browse Leaves - ID: M21701 - Name: Losartan - Relevance: HIGH - As Found: Monoclonal Antibody - ID: M1770 - Name: Telmisartan - Relevance: HIGH - As Found: Led - ID: M4213 - Name: Anti-Arrhythmia Agents - Relevance: LOW - As Found: Unknown - ID: M4277 - Name: Antihypertensive Agents - Relevance: LOW - As Found: Unknown - ID: M4132 - Name: Angiotensin II - Relevance: LOW - As Found: Unknown - ID: M289354 - Name: Giapreza - Relevance: LOW - As Found: Unknown - ID: M4135 - Name: Angiotensinogen - Relevance: LOW - As Found: Unknown - ID: M25789 - Name: Angiotensin II Type 1 Receptor Blockers - Relevance: LOW - As Found: Unknown - ID: M28916 - Name: Angiotensin Receptor Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000019808 - Term: Losartan - ID: D000077333 - Term: Telmisartan ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431464 **Brief Title:** Tattoo Particles: Picosecond Laser Versus Nanosecond Laser **Official Title:** In Vivo Analysis of Tattoo Particles After Picosecond Laser Compared to Nanosecond Laser #### Organization Study ID Info **ID:** 02-24 #### Organization **Class:** OTHER **Full Name:** Universitätsklinikum Hamburg-Eppendorf ### Status Module #### Completion Date **Date:** 2024-07-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-02-19 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universitätsklinikum Hamburg-Eppendorf #### Responsible Party **Investigator Affiliation:** Universitätsklinikum Hamburg-Eppendorf **Investigator Full Name:** Lynhda Nguyen **Investigator Title:** Principle investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** - For treating unwanted tattoos, the gold standard treatment is a nanosecond or picosecond laser. However, comparative microscopic analysis is limited. Therefore, the aim of the present study is to analysis morphological changes of tattoo particles and surrounding tissue in human skin. ### Conditions Module **Conditions:** - Tattoo; Pigmentation ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with unwanted tattoos who plan a nanosecond laser treatment will be recruited for measurements using a multiphoton-tomography system. **Intervention Names:** - Other: nanosecond laser treatment + measurement with a multiphoton tomography system **Label:** Nanosecond laser #### Arm Group 2 **Description:** Patients with unwanted tattoos who plan a picosecond laser treatment will be recruited for measurements using a multiphoton-tomography system. **Intervention Names:** - Other: picosecond laser treatment + measurement with a multiphoton tomography system **Label:** Picosecond laser ### Interventions #### Intervention 1 **Arm Group Labels:** - Picosecond laser **Description:** Patients with unwanted tattoos who plan a laser treatment will be recruited for measurements using a multiphoton-tomography system. These are scheduled 6 weeks and 12 weeks post-treatment. **Name:** picosecond laser treatment + measurement with a multiphoton tomography system **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Nanosecond laser **Description:** Patients with unwanted tattoos who plan a laser treatment will be recruited for measurements using a multiphoton-tomography system. These are scheduled 6 weeks and 12 weeks post-treatment. **Name:** nanosecond laser treatment + measurement with a multiphoton tomography system **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Size of intercellular spaces after picosecond or nanosecond laser treatment. **Measure:** Size of intercellular spaces **Time Frame:** 6 weeks and 12 weeks post-treatment **Description:** Size of keratinocytes after picosecond or nanosecond laser treatment. **Measure:** Size of keratinocytes **Time Frame:** 6 weeks and 12 weeks post-treatment **Description:** Size of tattoo particles after picosecond or nanosecond laser treatment. **Measure:** Size of tattoo particles **Time Frame:** 6 weeks and 12 weeks post-treatment **Description:** Distribution though the epidermal and dermal layers after picosecond or nanosecond laser treatment. **Measure:** Distribution of tattoo particles **Time Frame:** 6 weeks and 12 weeks post-treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: - healthy patients who plan a laser treatment of their unwanted tattoo/ tattoos at our department Exclusion Criteria: * laser pretreatment of their tattoos to be treated * pregnancy, breast feeding * open wound on the area to be treated **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** - healthy patients who plan a laser treatment of their unwanted tattoo/ tattoos at our department ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Lynhda Nguyen, Dr. med. **Phone:** +49 (0) 7410-0 **Role:** CONTACT #### Locations **Location 1:** **City:** Hamburg **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** L Nguyen, Dr. med. - **Phone:** +49 (0)40-74100 - **Role:** CONTACT **Country:** Germany **Facility:** University Medical Center Hamburg-Eppendorf **Status:** RECRUITING **Zip:** 20251 ### References Module #### References **Citation:** Nguyen L, Mess C, Schneider SW, Huck V, Herberger K. In vivo visualisation of tattoo particles using multiphoton tomography and fluorescence lifetime imaging. Exp Dermatol. 2022 Nov;31(11):1712-1719. doi: 10.1111/exd.14646. Epub 2022 Jul 25. **PMID:** 35837813 ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431451 **Brief Title:** The Correlation Between Ripretinib Exposure and the Efficacy and Safety in Patients With Advanced GISTs **Official Title:** The Correlation Between Ripretinib Exposure and the Efficacy and Safety in Patients With Advanced Gastrointestinal Stromal Tumors: an Observational Study #### Organization Study ID Info **ID:** 20240102v3.0 #### Organization **Class:** OTHER **Full Name:** First Affiliated Hospital, Sun Yat-Sen University ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2023-12-24 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** First Affiliated Hospital, Sun Yat-Sen University #### Responsible Party **Investigator Affiliation:** First Affiliated Hospital, Sun Yat-Sen University **Investigator Full Name:** Xinhua Zhang, MD **Investigator Title:** Chief physician **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a prospective, single-center, observational study to explore the correlation between ripretinib exposure and the efficacy and safety in patients with advanced gastrointestinal stromal tumors **Detailed Description:** INTRODUCTION AND RATIONALE: Gastrointestinal stromal tumors (GISTs) are a rare mesenchymal sarcoma that most commonly occur in the stomach and small intestine, but can occur in any region of the entire gastrointestinal tract. For advanced GISTs that cannot be surgically removed or metastasized, imatinib, sunitinib, and regorafenib are recommended TKIs in the current clinical guidelines for the first-, second-, and third-line therapy respectively. Although imatinib has significant effect in the first-line treatment of GIST, improving the prognosis and survival outcome, GISTs often develop primary or secondary drug resistance, resulting in disease progression.Ripretinib is a broad-spectrum switch-control kinase inhibitor that specifically inhibits KIT and PDGFRA kinase signaling through dual mechanisms of action. In clinical studies of advanced GIST patients, Ripretinib has shown good safety and efficacy. In the phase III clinical study INVICTUS, Ripretinib 150 mg QD was used to treat patients with metastatic or unresectable GIST who failed to treatment with imatinib, sunitinib, and regorafenib. The median progression-free survival (mPFS) was 6.3 months in the Ripretinib group and 1.0 month in the placebo group. The phase III clinical trial INTRIGUE showed that although there was no significant advantage in progression-free survival (PFS) compared with sunitinib, Ripretinib had better safety, lower incidence of adverse events, and better patient tolerability. In May 2020, Ripretinib was approved by the US FDA for the treatment of adult patients with advanced GIST who have failed to three or more kinase inhibitors including imatinib. It is also recommended as a preferred fourth-line drug in the 2023 version of the NCCN guidelines and the 2022 version of the CSCO guidelines for GISTs. In vitro kinase and cell studies have shown that Ripretinib is effective against wild-type KIT and PDGFRA, as well as a wide range of KIT and PDGFRA mutations, including major and resistant mutations in KIT exons 9, 11, 13, 14, 17, and 18, as well as the regorafenib-resistant D816V mutation. It is more effective than other type I and type II TKI inhibitors. However, the inhibitory effect of Ripretinib varies depending on the mutation type. At the same time, in the phase III clinical study INVICTUS gene mutation analysis, it was found that patients with primary mutations in KIT exon 11 and secondary mutations in KIT exon 17 had a relatively longer PFS. The preclinical study of Ripretinib suggests that its inhibitory effect on KIT is concentration-dependent and time-dependent. With the increase of in vivo concentration, the inhibitory effect of KIT phosphorylation also increases. Increasing the dosage or dosing frequency can increase tumor regression and survival rates. In the phase I clinical study of Ripretinib, it was found that increasing the dose to 150 mg BID after oral administration of 150mg QD with disease progression (PD) can obtain a further benefit. The median progression-free survival (mPFS) of second-line, third-line, and fourth-line patients was 5.6, 3.3, and 4.6 months, respectively, indicating that the increase of Ripretinib's exposure in vivo is associated with improved efficacy. Preclinical and clinical studies have found that the main metabolic pathway of Ripretinib is N-demethylation. Ripretinib and its active metabolite DP-5439 are mainly metabolized in the liver through CYP3A4 metabolic enzymes, and DP-5439 has pharmacological activity similar to the parent drug Ripretinib. In a phase I clinical study of pharmacokinetics, there was significant inter-patient variability in PK parameters after administration of Ripretinib. The variation (CV%) of Cmax and AUC0-24h reached 35% to 60%. The AUC of DP-5439 after a single dose of 150 mg was about 49% of Ripretinib, and the AUC after 15 days of dosing at 150 mg QD was about 129% of Ripretinib. At the same time, the AUC0-24h of Ripretinib increased proportionally with dose within the range of 20-250 mg, but the Cmax increased less than dose proportionally. The Cmax and AUC0-24h of DP-5439 increased less than dose proportionally within the range of 50-250 mg.The above findings suggest that therapeutic drug monitoring (TDM) may be clinically relevant for patients receiving Ripretinib treatment, and further exploration of the relationship between blood concentration or exposure level of Ripretinib and clinical efficacy is warranted. In terms of safety, in the phase I dose-escalation trial of Ripretinib, no maximum tolerated dose (MTD) was found, and the dose-limiting toxicity (DLT) was elevation of lipase and creatine kinase, which occurred in dose groups of 100 mg BID, 200 mg BID, and 150 mg QD. The most common treatment-related adverse events included fatigue, alopecia, nausea, muscle pain, constipation, loss of appetite, palmoplantar erythrodysesthesia syndrome (PPES), diarrhea, and elevation of lipase. Most of these events were mild to moderate. The incidence of serious adverse events was 14.1%, including elevation of creatine kinase, elevation of lipase, elevation of bilirubin, myocardial infarction, and heart failure. In the phase I dose-escalation trial, it was shown that the incidence of adverse events such as muscle pain, muscle spasms, PPES, and hypertension increased with dose escalation, indicating a possible dose-related toxicity. Therefore, in order to reduce the occurrence of adverse reactions and improve medication safety, it is of great significance to find a relatively safe dose range to guide clinical safe drug use. In addition, although the results of the phase II clinical trial of Ripretinib in China suggested that the efficacy, safety, and PK characteristics of Ripretinib in Chinese patients were consistent with the global patient population, a comparison of the results between Chinese patients and global patients in the phase I clinical trial showed that the clinical efficacy of Chinese patients receiving Ripretinib as a fourth-line treatment at a dose of 150 mg QD was slightly better than that of global patients (mPFS: 7.2 vs. 6.3 months; ORR: 18.4% vs. 11.8%). Meanwhile, the overall exposure of Ripretinib and DP-5439 was slightly higher in the Chinese population compared to global data. This suggests that it is worth further exploring the relationship between the pharmacokinetics and exposure of Ripretinib in the Chinese population and its efficacy, which has implications for personalized treatment in Chinese patients. This study aims to establish a method for monitoring the blood concentrations of Ripretinib and its active metabolite DP-5439, and to monitor the blood concentrations of advanced GIST patients receiving Ripretinib treatment. The study will explore the relationship between the exposure of Ripretinib and its efficacy and safety in real-world advanced GIST patients, determine the therapeutic window of Ripretinib, and explore the effective exposure levels required for different KIT mutation types. ### Conditions Module **Conditions:** - Gastrointestinal Stromal Tumors **Keywords:** - Ripretinib - plasma drug concentration ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** The concentration of ripretinib in the plasma was measured. **Measure:** Plasma Concentration of ripretinib **Time Frame:** Before Dosing and at 0.5, 1, 2, 4, 6, 8,12 and 24 Hours after Dosing **Description:** The concentration of DP-5439 in the plasma was measured. **Measure:** Plasma Concentration of DP-5439 **Time Frame:** Before Dosing and at 0.5, 1, 2, 4, 6, 8,12 and 24 Hours after Dosing **Description:** To evaluate objective response rate (ORR,CR+PR) determined by radiology assessment per mRECIST(Response Evaluation Criteriain Solid Tumours), version 1.1 in patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors.Complete response is the disappearance of all lesions with lymph nodes measuring \< 10 mm and normal tumour markers.A decrease in the sum of target disease of ≥ 30% represents partial response. **Measure:** Objective Response Rate **Time Frame:** 2 years **Description:** To evaluate disease control rate (CBR,CR+PR+\>16 weeks continuation SD) determined by radiology assessment per mRECIST, version 1.1 in patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors.Complete response is the disappearance of all lesions with lymph nodes measuring \< 10 mm and normal tumour markers.A decrease in the sum of target disease of ≥ 30% represents partial response.Stable disease lies between partial response and progressive disease. **Measure:** Disease control rate **Time Frame:** 2 years #### Secondary Outcomes **Description:** Progression-free survival (PFS) is defined as the interval between the date of drug administration and the earliest date of disease progression or death due to any cause. **Measure:** Progression-free survival **Time Frame:** 2 years **Description:** Overall survival is defined as the time from drug administration until death. **Measure:** overall survival **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients who are aged ≥ 18 years. * Gastrointestinal stromal tumors confirmed by histopathological examination, and CD117 and/or DOG-1-positive by immunohistochemistry. * patients who are currently receiving Ripretinib treatment. * Subjects must have at least one measurable lesion based on mRECIST v1.1 criteria, and have undergone at least one radiographic evaluation for efficacy analysis. * Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 4 * Patient informed consent and signed written consent form. * The patient was compliant and voluntarily scheduled for follow-up, treatment, laboratory tests, and other study procedures. Exclusion Criteria: * Unable to complete at least 15 consecutive days of Ripretinib due to intolerance or disease progression. * Individuals with other serious acute or chronic physical or mental health problems, or abnormal laboratory test results that increase the risk associated with participation in the study or use of the drug, or that could interfere with the interpretation of study results, and who, in the opinion of the investigator, are not suitable for participation in the study. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Gastrointestinal stromal tumor patients who are receiving treatment with Ripretinib at the research center. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** xinhua zhang, MD **Phone:** +8613828463644 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** yanzhe xia, MD **Phone:** +8618680238481 **Role:** CONTACT ### References Module #### References **Citation:** von Mehren M, Joensuu H. Gastrointestinal Stromal Tumors. J Clin Oncol. 2018 Jan 10;36(2):136-143. doi: 10.1200/JCO.2017.74.9705. Epub 2017 Dec 8. **PMID:** 29220298 **Citation:** Di Vito A, Ravegnini G, Gorini F, Aasen T, Serrano C, Benuzzi E, Coschina E, Monesmith S, Morroni F, Angelini S, Hrelia P. The multifaceted landscape behind imatinib resistance in gastrointestinal stromal tumors (GISTs): A lesson from ripretinib. Pharmacol Ther. 2023 Aug;248:108475. doi: 10.1016/j.pharmthera.2023.108475. Epub 2023 Jun 10. **PMID:** 37302758 **Citation:** Zalcberg JR. Ripretinib for the treatment of advanced gastrointestinal stromal tumor. Therap Adv Gastroenterol. 2021 Apr 15;14:17562848211008177. doi: 10.1177/17562848211008177. eCollection 2021. **PMID:** 33948116 **Citation:** Janku F, Abdul Razak AR, Chi P, Heinrich MC, von Mehren M, Jones RL, Ganjoo K, Trent J, Gelderblom H, Somaiah N, Hu S, Rosen O, Su Y, Ruiz-Soto R, Gordon M, George S. Switch Control Inhibition of KIT and PDGFRA in Patients With Advanced Gastrointestinal Stromal Tumor: A Phase I Study of Ripretinib. J Clin Oncol. 2020 Oct 1;38(28):3294-3303. doi: 10.1200/JCO.20.00522. Epub 2020 Aug 17. **PMID:** 32804590 **Citation:** Smith BD, Kaufman MD, Lu WP, Gupta A, Leary CB, Wise SC, Rutkoski TJ, Ahn YM, Al-Ani G, Bulfer SL, Caldwell TM, Chun L, Ensinger CL, Hood MM, McKinley A, Patt WC, Ruiz-Soto R, Su Y, Telikepalli H, Town A, Turner BA, Vogeti L, Vogeti S, Yates K, Janku F, Abdul Razak AR, Rosen O, Heinrich MC, Flynn DL. Ripretinib (DCC-2618) Is a Switch Control Kinase Inhibitor of a Broad Spectrum of Oncogenic and Drug-Resistant KIT and PDGFRA Variants. Cancer Cell. 2019 May 13;35(5):738-751.e9. doi: 10.1016/j.ccell.2019.04.006. **PMID:** 31085175 **Citation:** Klug LR, Khosroyani HM, Kent JD, Heinrich MC. New treatment strategies for advanced-stage gastrointestinal stromal tumours. Nat Rev Clin Oncol. 2022 May;19(5):328-341. doi: 10.1038/s41571-022-00606-4. Epub 2022 Feb 25. **PMID:** 35217782 **Citation:** Blay JY, Serrano C, Heinrich MC, Zalcberg J, Bauer S, Gelderblom H, Schoffski P, Jones RL, Attia S, D'Amato G, Chi P, Reichardt P, Meade J, Shi K, Ruiz-Soto R, George S, von Mehren M. Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2020 Jul;21(7):923-934. doi: 10.1016/S1470-2045(20)30168-6. Epub 2020 Jun 5. Erratum In: Lancet Oncol. 2020 Jul;21(7):e341. **PMID:** 32511981 **Citation:** Bauer S, Jones RL, Blay JY, Gelderblom H, George S, Schoffski P, von Mehren M, Zalcberg JR, Kang YK, Razak AA, Trent J, Attia S, Le Cesne A, Su Y, Meade J, Wang T, Sherman ML, Ruiz-Soto R, Heinrich MC. Ripretinib Versus Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumor After Treatment With Imatinib (INTRIGUE): A Randomized, Open-Label, Phase III Trial. J Clin Oncol. 2022 Dec 1;40(34):3918-3928. doi: 10.1200/JCO.22.00294. Epub 2022 Aug 10. **PMID:** 35947817 **Citation:** Li J, Cai S, Zhou Y, Zhang J, Zhou Y, Cao H, Wu X, Deng Y, Huang Z, Dong J, Shen L. Efficacy and Safety of Ripretinib in Chinese Patients with Advanced Gastrointestinal Stromal Tumors as a Fourth- or Later-Line Therapy: A Multicenter, Single-Arm, Open-Label Phase II Study. Clin Cancer Res. 2022 Aug 15;28(16):3425-3432. doi: 10.1158/1078-0432.CCR-22-0196. **PMID:** 35686969 **Citation:** George S, Chi P, Heinrich MC, von Mehren M, Jones RL, Ganjoo K, Trent J, Gelderblom H, Razak AA, Gordon MS, Somaiah N, Jennings J, Meade J, Shi K, Su Y, Ruiz-Soto R, Janku F. Ripretinib intrapatient dose escalation after disease progression provides clinically meaningful outcomes in advanced gastrointestinal stromal tumour. Eur J Cancer. 2021 Sep;155:236-244. doi: 10.1016/j.ejca.2021.07.010. Epub 2021 Aug 12. **PMID:** 34391056 **Citation:** Zalcberg JR, Heinrich MC, George S, Bauer S, Schoffski P, Serrano C, Gelderblom H, Jones RL, Attia S, D'Amato G, Chi P, Reichardt P, Somaiah N, Meade J, Reichert V, Shi K, Sherman ML, Ruiz-Soto R, von Mehren M, Blay JY. Clinical Benefit of Ripretinib Dose Escalation After Disease Progression in Advanced Gastrointestinal Stromal Tumor: An Analysis of the INVICTUS Study. Oncologist. 2021 Nov;26(11):e2053-e2060. doi: 10.1002/onco.13917. Epub 2021 Aug 16. **PMID:** 34313371 **Citation:** Pan C, Cheng Y, He Q, Li M, Bu F, Zhu X, Li X, Xiang X. Evaluating the impact of co-administered drug and disease on ripretinib exposure: A physiologically-based pharmacokinetic modeling approach. Chem Biol Interact. 2023 Mar 1;373:110400. doi: 10.1016/j.cbi.2023.110400. Epub 2023 Feb 9. **PMID:** 36773833 **Citation:** Li X, Shelton MJ, Wang J, Meade J, Ruiz-Soto R. Effects of CYP3A Inhibition, CYP3A Induction, and Gastric Acid Reduction on the Pharmacokinetics of Ripretinib, a Switch Control KIT Tyrosine Kinase Inhibitor. Clin Pharmacol Drug Dev. 2022 Oct;11(10):1165-1176. doi: 10.1002/cpdd.1110. Epub 2022 May 13. **PMID:** 35560823 **Citation:** Demetri GD, Wang Y, Wehrle E, Racine A, Nikolova Z, Blanke CD, Joensuu H, von Mehren M. Imatinib plasma levels are correlated with clinical benefit in patients with unresectable/metastatic gastrointestinal stromal tumors. J Clin Oncol. 2009 Jul 1;27(19):3141-7. doi: 10.1200/JCO.2008.20.4818. Epub 2009 May 18. **PMID:** 19451435 **Citation:** Yang W, Qian H, Yang L, Wang P, Qian H, Chu B, Liu Z, Sun J, Wu D, Sun L, Zhou W, Hu J, Chen X, Shou C, Ruan L, Zhang Y, Yu J. Efficacy and safety of ripretinib in Chinese patients with advanced gastrointestinal stromal tumors: a real-world, multicenter, observational study. Front Oncol. 2023 May 18;13:1180795. doi: 10.3389/fonc.2023.1180795. eCollection 2023. **PMID:** 37274264 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009372 - Term: Neoplasms, Connective Tissue - ID: D000018204 - Term: Neoplasms, Connective and Soft Tissue - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M25642 - Name: Gastrointestinal Stromal Tumors - Relevance: HIGH - As Found: Gastrointestinal Stromal Tumors - ID: M12317 - Name: Neoplasms, Connective Tissue - Relevance: LOW - As Found: Unknown - ID: M20350 - Name: Neoplasms, Connective and Soft Tissue - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: 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: T2444 - Name: Gastrointestinal Stromal Tumors - Relevance: HIGH - As Found: Gastrointestinal Stromal Tumors ### Condition Browse Module - Meshes - ID: D000046152 - Term: Gastrointestinal Stromal Tumors ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431438 **Brief Title:** Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of TQA3810 Tablets **Official Title:** A Phase I Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of TQA3810 Tablets #### Organization Study ID Info **ID:** TQA3810-I-01 #### Organization **Class:** INDUSTRY **Full Name:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ### Status Module #### Completion Date **Date:** 2023-11-20 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-11-20 **Type:** ACTUAL #### Start Date **Date:** 2021-10-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study was a single-center study, including randomized, double-blind, placebo-controlled, single-dose escalation study, multiple-dose study, food effect on pharmacokinetics and drug metabolism transformation study, drug interaction study. To evaluate the tolerability, pharmacokinetics and metabolic transformation of TQA3810 in healthy subjects after single or multiple doses of TQA3810, the drug-drug interactions between TQA3810 tablets and entecavir dispersible tablets, and the pharmacokinetic properties of TQA3810 tablets in combination. ### Conditions Module **Conditions:** - Chronic Hepatitis B ### 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:** 759 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. **Intervention Names:** - Drug: TQA3810 **Label:** 0.5mg single-dose **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. **Intervention Names:** - Drug: TQA3810 **Label:** 1.0mg single-dose **Type:** PLACEBO_COMPARATOR #### Arm Group 3 **Description:** Sixteen subjects were enrolled and all received the trial drug. **Intervention Names:** - Drug: TQA3810 **Label:** Food impact group **Type:** OTHER #### Arm Group 4 **Description:** Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. **Intervention Names:** - Drug: TQA3810 **Label:** 0.1mg single-dose **Type:** PLACEBO_COMPARATOR #### Arm Group 5 **Description:** Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. **Intervention Names:** - Drug: TQA3810 **Label:** 0.3mg single-dose **Type:** PLACEBO_COMPARATOR #### Arm Group 6 **Description:** Sixteen subjects were enrolled and all received the trial drug. **Intervention Names:** - Drug: TQA3810 **Label:** Drug interaction group **Type:** ACTIVE_COMPARATOR #### Arm Group 7 **Description:** Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. **Intervention Names:** - Drug: TQA3810 **Label:** 0.1mg multiple dosing **Type:** PLACEBO_COMPARATOR #### Arm Group 8 **Description:** Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. **Intervention Names:** - Drug: TQA3810 **Label:** 0.3mg multiple dosing **Type:** PLACEBO_COMPARATOR #### Arm Group 9 **Description:** Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. **Intervention Names:** - Drug: TQA3810 **Label:** 0.5mg multiple dosing **Type:** PLACEBO_COMPARATOR #### Arm Group 10 **Description:** Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. **Intervention Names:** - Drug: TQA3810 **Label:** 0.2mg multiple dosing **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - 0.1mg multiple dosing - 0.1mg single-dose - 0.2mg multiple dosing - 0.3mg multiple dosing - 0.3mg single-dose - 0.5mg multiple dosing - 0.5mg single-dose - 1.0mg single-dose - Drug interaction group - Food impact group **Description:** TQA3810 is a small-molecule Toll-like receptor (TLR8) agonist **Name:** TQA3810 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Occurrence of all adverse events (AEs), serious adverse events (SAEs), and treatment-related adverse events (TEAEs) were recorded. **Measure:** Incidence of Adverse Events **Time Frame:** From the subject signed the informed consent form to 30 days after the last dose #### Secondary Outcomes **Description:** Maximum plasma drug concentration **Measure:** Cmax **Time Frame:** Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose **Description:** To maximum plasma drug concentration time. **Measure:** Tmax **Time Frame:** Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose **Description:** Drug half-life in plasma. **Measure:** Half-life (t1/2) **Time Frame:** Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose **Description:** Plasma drug concentration from time 0 to the last measurable area under the drug concentration time curve. **Measure:** AUC0-t **Time Frame:** Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose **Description:** Area under the plasma drug concentration time curve from time 0 to infinity. **Measure:** AUC0-∞ **Time Frame:** Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions; * Able to complete the study according to the requirements of the trial protocol; * The participants (including their partners) are willing to voluntarily use effective contraceptive methods within 6 months from screening until the last dose of study drug, as detailed in the Appendix; * Male and female subjects aged 18-55 years old (including 18 and 55 years old); * The body weight of male subjects should not be less than 50 kg and the body weight of female subjects should not be less than 45 kg. Body mass index (BMI) = weight (kg)/height 2 (m2), BMI in the range of 18-28 kg/m2 (including the cut-off value); * The physical examination and vital signs were normal or abnormal without clinical significance. Exclusion Criteria: * Smoking more than 5 cigarettes per day in the 3 months before the study; * Allergic constitution (multi-drug and food allergy); * A history of drug and/or alcohol abuse (drinking 14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 ml wine); * Donation or massive blood loss (\> 400 mL) within 3 months before screening; * Taking any drugs that alter liver enzyme activity 28 days before screening; * Have taken any prescription medication, over-the-counter medication, any vitamin product or herbal medicine within 14 days before screening; * Those who had taken special diet (including dragon fruit, mango, grapefruit, etc.) or had strenuous exercise within 2 weeks before screening, or had other factors affecting drug absorption, distribution, metabolism, and excretion; * Combined with the following inhibitors or inducers of CYP3A4, P-gp, or Bcrp, such as itraconazole, ketoconazole, or dronedarone, within three months before taking the study drug; * A recent major change in diet or exercise habits; * Have taken a study drug or participated in a clinical trial of the drug within three months before taking the study drug; * A history of dysphagia or any gastrointestinal disorder affecting drug absorption or a history of cholecystectomy or biliary tract disease; * Have any condition that increases the risk of bleeding, such as hemorrhoids, acute gastritis or gastric and duodenal ulcers; * With severe systemic diseases and related medical history (including subjects with active or occult tuberculosis, a history of tuberculosis, or clinical manifestations suspected of tuberculosis), as well as immune system diseases and medical history; * Had systemic or local infection within 2 months prior to screening, and were hospitalized for severe infection and/or required intravenous antibiotics; * Subjects who were unable to tolerate a standard meal; * An electrocardiogram (ECG) abnormalities have clinical significance; * The female subjects were lactating or seropositive for pregnancy during the screening or test period; * Clinically significant abnormalities on clinical examination or other clinical findings within 6 months prior to screening (including but not limited to gastrointestinal, renal, hepatic, neurological, hematologic, endocrine, oncologic, pulmonary, immune, psychiatric, or cardio-cerebrovascular diseases); * Clinically significant fundus lesions (symptomatic cotton-like fundus changes) and retinopathy; * Viral hepatitis (including hepatitis B and C), AIDS antibody, treponema pallidum antibody positive; * From the screening stage to the onset of acute illness or concomitant medication before study medication; * Consumption of chocolate, any caffeinated or xanthine-rich food or beverage 24 hours before taking the study drug; * Have taken any alcohol-based product within 24 hours before taking the study medication; * Having a positive urine drug screen or having a history of drug abuse or drug use in the past 5 years; * Subjects with other factors considered by the investigator to be ineligible for the trial. **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Nanjing **Country:** China **Facility:** Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University **State:** Jiangsu **Zip:** 210008 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006505 - Term: Hepatitis - ID: D000008107 - Term: Liver Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000086982 - Term: Blood-Borne Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000007239 - Term: Infections - ID: D000018347 - Term: Hepadnaviridae Infections - ID: D000004266 - Term: DNA Virus Infections - ID: D000014777 - Term: Virus Diseases - ID: D000006525 - Term: Hepatitis, Viral, Human - ID: D000006521 - Term: Hepatitis, Chronic - 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: 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: M9592 - Name: Hepatitis A - Relevance: LOW - As Found: Unknown - ID: M9591 - Name: Hepatitis - Relevance: LOW - As Found: Unknown - ID: M9595 - Name: Hepatitis B - Relevance: HIGH - As Found: Hepatitis B - ID: M21609 - Name: Hepatitis B, Chronic - Relevance: HIGH - As Found: Chronic Hepatitis B - ID: M9607 - Name: Hepatitis, Chronic - Relevance: LOW - As Found: Unknown - ID: M11107 - Name: Liver 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: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M2593 - Name: Blood-Borne Infections - Relevance: LOW - As Found: Unknown - ID: M20487 - Name: Hepadnaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M7442 - Name: DNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M9610 - Name: Hepatitis, Viral, Human - 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: D000006509 - Term: Hepatitis B - ID: D000019694 - Term: Hepatitis B, Chronic ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431425 **Acronym:** eCG **Brief Title:** The Electronic Cardiovascular Genetics (eCG) Clinic for Presymptomatic Genetic Counselling **Official Title:** The Electronic Cardiovascular Genetics (eCG) Clinic for Presymptomatic Genetic Counselling: Evaluation of Uptake, Psychological Impact and Satisfaction Among Users #### Organization Study ID Info **ID:** IMDI104021006 #### Organization **Class:** OTHER **Full Name:** UMC Utrecht ### Status Module #### Completion Date **Date:** 2025-11-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-11-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Amsterdam UMC **Class:** OTHER **Name:** University Medical Center Groningen **Class:** OTHER **Name:** Radboud University Medical Center #### Lead Sponsor **Class:** OTHER **Name:** UMC Utrecht #### Responsible Party **Investigator Affiliation:** UMC Utrecht **Investigator Full Name:** Lieke M van den Heuvel, PhD **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:** Inherited cardiovascular conditions generally inherit following an autosomal dominant pattern. When a mutation is detected in the proband, relatives can have predictive DNA testing, and - when they are carrier - be monitored and timely treated if needed. Currently, less than half of relatives attends genetic counselling. With the eCG Family Clinic, an easily accessible virtual clinic which better suits the needs and preferences of relatives will be offered. At the eCG Family Clinic, relatives will receive tailored information to support informed decision-making, a DNA-test at home if desired, and can be referred for local cardiac monitoring if relatives appear to be a carrier. Implementation of the eCG Family Clinic in clinical practice is compared to current practice in this clinical trial. **Detailed Description:** Background: Inherited cardiovascular conditions generally inherit following an autosomal dominant pattern. When a mutation is detected in the proband, relatives can have predictive DNA testing, and - when they are carrier - be monitored and timely treated if needed. Currently, less than half of relatives attends genetic counselling. With the eCG Family Clinic, an easily accessible virtual clinic which better suits the needs and preferences of relatives will be offered. At the eCG Family Clinic, relatives will receive tailored information to support informed decision-making, a DNA-test at home if desired, and can be referred for local cardiac monitoring if relatives appear to be a carrier. Implementation of the eCG Family Clinic in clinical practice (intervention group) is compared to current practice (control group) in this clinical trial. Hypotheses: It is hypothesized that the eCG Family Clinic can lower practical barriers for at-risk relatives to attend genetic counselling and equally or better suit the needs of probands and relatives in this regard. A higher uptake of presymptomatic counselling in the eCG Family Clinic (intervention) group is expected. Design: A non-inferiority randomised controlled trial (RCT) design with two study arms (parallel-group, control- and intervention group) for this study was chosen. In this study, probands, at-risk relatives and genetic healthcare professionals will be recruited for this study. The Medical Ethical Committee of the University Medical Centre Utrecht (UMCU, NedMec) has approved the study design. Measures: In this RCT, the following outcome measures will be evaluated: (1) uptake of presymptomatic counselling among at-risk relatives, (2) satisfaction with provided care among healthcare professionals, probands and at-risk relatives, (3) impact on feelings of anxiety and worry among at-risk relatives, (4) time requested for care provision and administration. Uptake of presymptomatic testing will be evaluated using file research. Data on the other outcome measures will be collected using questionnaires. First, probands will be asked to fill out one questionnaire after informing at-risk relatives. In addition, at-risk relatives are asked to fill out a questionnaire twice: (a) shortly after the presymptomatic counselling (time-point 1) and, (b) after two/three months, in which at-risk relatives who chose to have DNA-testing, will have received their results. Finally, healthcare professionals involved in providing counselling will be asked to fill out one questionnaire after study completion. Questionnaires will also be used to administer sociodemographic and clinical characteristics of study participants. Sample size calculation: Assuming a two-sided 5% significance level and a power of 80%, 238 at-risk relatives ( 119 per study arm) will be included. Previous literature shows that on average four adult relatives per proband are at 50% risk of inheriting the genetic mutation. Using a conservative estimate of 3.5 relatives per proband, a total of 68 probands (34 per study arm) needs to be included in this study. Statistical analyses: Sociodemographic and clinical characteristics will be analysed using descriptive and frequency statistics. Differences in participant characteristics between study arms will assessed with chi-square tests / t-tests, as appropriate. Differences in uptake of genetic counselling will be analysed using chi-square tests; logistic regression analyses will be conducted to assess differences in uptake while controlling for the influence of coviarates. Multilevel analyses will be performed to assess whether the study group has an impact on satisfaction with the care provided and impact on psychological functioning, adjusted for coviarates. SPSS version 29.0.1 will be used to perform statistical analyses. A p-level of p\<0.05 will be used. ### Conditions Module **Conditions:** - Inherited Cardiac Disease ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Non-inferiority randomised controlled trial with a parallel group design ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 170 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Individuals included in the intervention group (eCG Family Clinic), will receive an invitation to the DNA-poli platform after the proband adds their email address to the digital clinic at risk relatives list. The eCG Family Clinic serves as the pre-test counseling, afterwards counseling by a healthcare professional can be requested. Subsequently the at-risk relative decides whether to get genetically tested and if the results are communicated via the DNA-poli platform or via telephone. **Intervention Names:** - Behavioral: eCG Family Clinic **Label:** Digital care path (eCG Family Clinic) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Individuals included in the control group, will receive the family letter via the proband. The relative needs to contact their general practitioner to get a referral to the genetic department. The relative sets up an appointment with a genetic counselor. The relative has a face-to-face session with a healthcare professional and will decide during this conversation whether to get genetically tested. When results are in, another face-to-face appointment is set to discuss the result and if applicable, follow-up steps will be discussed. **Label:** Current clinical practice **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Digital care path (eCG Family Clinic) **Description:** The DNA-poli is an online tool which is designed as an addition to the current genetic counseling method to make the process more efficient and to increase the uptake without compromising counseling quality. Probands can invite their at-risk family members by entering their email addresses. The family members are invited to the DNA-poli via which they can get all the information needed to make a well-considered decision about genetic testing. The information is provided in different formats, for example via a virtual assistant and via videos, which they can evaluate at their own pace, and which can be reread or rewatched. Afterwards they can request an appointment with a health care professional and make a definite decision about genetic testing. **Name:** eCG Family Clinic **Other Names:** - DNA poli **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Uptake of genetic counselling and predictive DNA testing: i.e., the number of family members attending genetic counselling / pursuing genetic testing, relative to the total number of family members eligible for genetic counselling / genetic testing. **Measure:** Uptake **Time Frame:** 1 year post disclosure of the proband result **Description:** Measured using a self-constructed 9-item questionnaire, with answer options ranging from 1=totally disagree to 5=totally agree (score range: 0-36). In addition, the Dutch patient Satisfaction Questionnaire (PSQ) will be administered among relatives. This questionnaire consists of 5 questions using a 10-point scale (1=not at all to 10=a lot). Scores range from 0-45. A higher score indicates higher satisfaction. **Measure:** Experience with the eCG Family Clinic **Time Frame:** T1: on average 4 weeks, after counselling, T2: on average after 1/2 months, after receiving the DNA test results #### Secondary Outcomes **Description:** Measured using the genetic counseling outcome scale (GCOS). The GCOS consists of 24 questions using a 7-point likert scale (1=totally disagree to 7=totally agree). Total scores range from 0-144, with a higher score indicating higher empowerment. **Measure:** Empowerment / genetic counselling outcomes **Time Frame:** T1: on average 4 weeks, after counselling, T2: on average after 1/2 months, after receiving the DNA test results **Description:** Measured the Decisional Conflict Scale (DSC). The DSC consists of 16 questions using a 5 point Likert Scale (1=totally disagree, to 5= totally agree, total score range 0-64). A higher score indicates higher certainty about the decision made. Furthermore, informed decision-making is measures by 5 self-constructed knowledge questions, which can be answered with 'yes', 'no' or 'I don't know'. **Measure:** Informed decision-making **Time Frame:** T1: on average 4 weeks, after counselling, T2: on average after 1/2 months, after receiving the DNA test results **Description:** Measured using the shortened State Trait Anxiety Inventory (STAI). The shortened STAI consists of 6 questions on a 4 point Likert scale (1=not at all, 4=a lot). Total scores range from 0-18, with a higher score indicating higher levels of anxiety. **Measure:** Impact on feelings of anxiety **Time Frame:** T1: on average 4 weeks, after counselling, T2: on average after 1/2 months, after receiving the DNA test results **Description:** Measured by administering time needed for counselling / administration per at-risk relative **Measure:** Efficiency **Time Frame:** Administered per genetic consultation through study completion, on average two years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Probands: * \> 18 y/o * Diagnosed with inherited hypertrophic cardiomyopathy (HCM) or dialted cardiomyopathy (DCM)) * Class 4 or 5 variant identified. * Access to a working laptop or computer device. At risk relatives: * \> 18 y/o * First degree family member, or second degree in case of a deceased first degree relative * Access to a working laptop or computer device. Healthcare professionals: - Genetic counsellors of the genetics department directly involved in the care given to the family. Exclusion Criteria: - Insufficient control of the Dutch language or digital skills. **Maximum Age:** 90 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Marlies van Lingen, MSc. **Phone:** +31887553745 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Lieke van den Heuvel, PhD **Phone:** +31887553745 **Role:** CONTACT #### Locations **Location 1:** **City:** Utrecht **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Marlies van Lingen, MSc. - **Phone:** +31887553745 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Lieke van den Heuvel, PhD - **Phone:** +31887553745 - **Role:** CONTACT **Country:** Netherlands **Facility:** University Medical Centre Utrecht **Status:** RECRUITING **Zip:** 3584 CX ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - 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: M9419 - Name: Heart Diseases - Relevance: HIGH - As Found: Cardiac Disease ### Condition Browse Module - Meshes - ID: D000006331 - Term: Heart Diseases ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431412 **Brief Title:** A Model for Drug Concentration Prediction of Vancomycin **Official Title:** A Clinical Data-Based Model for Drug Concentration Prediction of Vancomycin in Critical Patients #### Organization Study ID Info **ID:** K5927 #### Organization **Class:** OTHER **Full Name:** Peking Union Medical College Hospital ### Status Module #### Completion Date **Date:** 2024-08-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-08-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Peking Union Medical College Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Objective: This study aims to use machine learning methods to establish an optimal model for predicting serum vancomycin trough concentrations in critically ill patients. Methods: This is a single-center, retrospective study. Data on serum vancomycin concentration in the Critical Care Database of Peking Union Medical College Hospital were screened and extracted to construct a prediction model using machine learning methods. The MIMIC-IV (Medical Information Mart for Intensive Care) database will be further used for external verification of the constructed model. The study has been approved by the Medical Ethics Committee of Peking Union Medical College Hospital (K24C1161). **Detailed Description:** Background: Vancomycin is a glycopeptide antibiotic primarily used to treat infections caused by methicillin-resistant Staphylococcus aureus (MRSA). As a time-dependent antibiotic, the serum concentration of vancomycin is closely related to the clinical efficacy, toxicity and emergence of drug resistance. Therefore, therapeutic drug monitoring (TDM) is considered an important component of vancomycin treatment management. According to vancomycin surveillance guidelines, It is recommended to maintain a serum vancomycin concentration of 15-20 mg/L in patients with severe infections in order to improve clinical outcomes and prevent drug resistance. However, serum vancomycin concentration testing is not widely used in clinical practices, especially in resource-constrained areas and medical institutions, so individualized monitoring remains a challenge. Currently, studies on vancomycin concentration prediction generally use the population pharmacokinetic (PPK) model. However, this model is affected by many factors such as age, weight, and creatinine clearance rate. However, since critically ill patients have complex diseases accompanied by multiple organ dysfunction, vancomycin pharmacokinetics may be altered. In such patients, the evidence for concentration prediction using PPK models is insufficient. Currently, the rapidly developing machine learning methods can help capture nonlinear variable relationships while making predictions through multiple variables to achieve a high degree of accuracy in prediction results. This study aims to use machine learning methods to establish an optimal model for predicting serum vancomycin trough concentrations in critically ill patients. Objective: This study aims to extract the serum vancomycin concentration data from the Critical Care Database of Peking Union Medical College Hospital from January 2014 to December 2023 and use machine learning methods to establish the optimal model for predicting vancomycin concentrations in critically ill patients. Methods: (1)This is a single-center, retrospective study. Data on serum vancomycin concentration in the Critical Care Database of Peking Union Medical College Hospital were screened. After meeting the eligibility criteria, the clinical data of included patients are collected through the inpatient medical record system, including demographic characteristics, severity scores, laboratory test information and treatment information. (2) After extracting the available data, five models of machine learning, including Linear Regression, Lasso Regression, Ridge Regression, Random Forest and LightGBM, are used to build prediction models. The model with the best prediction accuracy is selected based on the percent error (PE), the mean percentage error (MPE) and the mean absolute percentage error (MAPE). (3) The MIMIC-IV (Medical Information Mart for Intensive Care) database is used to conduct external validation of the model constructed by machine learning. Moreover, the investigators will compare the predictive performance of the PPK model with the constructed model. Quality control: Patients who meet the inclusion criteria are included. Patients with missing information are not enrolled in order to reduce bias. The information of included patients is recorded and registered by a dedicated research person. Ethics and patient privacy protection: Personal information in the study will be used only for the purposes described in the protocol for this study. Medical information obtained will be kept confidential. The results will also be published in academic journals without revealing any identifiable patient information. The study has been approved by the Medical Ethics Committee of Peking Union Medical College Hospital (K24C1161). ### Conditions Module **Conditions:** - Critical Illness - Infections - Drug Use **Keywords:** - Serum vancomycin concentration - Machine learning ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 401 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** no intervention **Name:** no intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The serum vancomycin concentration predicted by the constructed model **Measure:** The predicted serum vancomycin concentration **Time Frame:** 1 day ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥18 years; * Patients admitted to ICUs; * Patients were administered intravenous vancomycin; * Vancomycin TDM was performed at least two times. Exclusion Criteria: * Vancomycin TDM was performed in a ward rather than in an ICU; * Patients with missing data. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adult ICU patients who receivied intravenous vancomycin treatment ### Contacts Locations Module #### Locations **Location 1:** **City:** Beijing **Country:** China **Facility:** Peking Union Medical College Hospita **State:** Beijing **Zip:** 100730 #### Overall Officials **Official 1:** **Affiliation:** Peking Union Medical College Hospital **Name:** Li Weng, MD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Ye ZK, Li C, Zhai SD. Guidelines for therapeutic drug monitoring of vancomycin: a systematic review. PLoS One. 2014 Jun 16;9(6):e99044. doi: 10.1371/journal.pone.0099044. eCollection 2014. **PMID:** 24932495 **Citation:** Ingram PR, Lye DC, Tambyah PA, Goh WP, Tam VH, Fisher DA. Risk factors for nephrotoxicity associated with continuous vancomycin infusion in outpatient parenteral antibiotic therapy. J Antimicrob Chemother. 2008 Jul;62(1):168-71. doi: 10.1093/jac/dkn080. Epub 2008 Mar 10. **PMID:** 18334494 **Citation:** Rybak MJ, Le J, Lodise TP, Levine DP, Bradley JS, Liu C, Mueller BA, Pai MP, Wong-Beringer A, Rotschafer JC, Rodvold KA, Maples HD, Lomaestro B. Therapeutic Monitoring of Vancomycin for Serious Methicillin-resistant Staphylococcus aureus Infections: A Revised Consensus Guideline and Review by the American Society of Health-system Pharmacists, the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the Society of Infectious Diseases Pharmacists. Clin Infect Dis. 2020 Sep 12;71(6):1361-1364. doi: 10.1093/cid/ciaa303. **PMID:** 32658968 **Citation:** Yasuhara M, Iga T, Zenda H, Okumura K, Oguma T, Yano Y, Hori R. Population pharmacokinetics of vancomycin in Japanese adult patients. Ther Drug Monit. 1998 Apr;20(2):139-48. doi: 10.1097/00007691-199804000-00003. **PMID:** 9558127 **Citation:** Obermeyer Z, Emanuel EJ. Predicting the Future - Big Data, Machine Learning, and Clinical Medicine. N Engl J Med. 2016 Sep 29;375(13):1216-9. doi: 10.1056/NEJMp1606181. No abstract available. **PMID:** 27682033 **Citation:** Doupe P, Faghmous J, Basu S. Machine Learning for Health Services Researchers. Value Health. 2019 Jul;22(7):808-815. doi: 10.1016/j.jval.2019.02.012. **PMID:** 31277828 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### 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: M19010 - Name: Critical Illness - Relevance: HIGH - As Found: Critical Illness - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016638 - Term: Critical Illness ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M17388 - Name: Vancomycin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431399 **Brief Title:** To Evaluate the Safety, Pharmacokinetic Characteristics and the Effect of Food After Administration of JLP-2004 **Official Title:** A Randomized, Open-label, Crossover Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetic Characteristics and the Effect of Food After Administration of JLP-2004 in Healthy Adult Volunteers #### Organization Study ID Info **ID:** JP-2004-102 #### Organization **Class:** INDUSTRY **Full Name:** Jeil Pharmaceutical Co., Ltd. ### Status Module #### Completion Date **Date:** 2024-07-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-23 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Jeil 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:** To evaluate the safety, pharmacokinetic characteristics and the effect of food after administration of JLP-2004 **Detailed Description:** A randomized, open-label, crossover phase 1 clinical trial to evaluate the safety, pharmacokinetic characteristics and the effect of food after administration of JLP-2004 in healthy adult volunteers ### Conditions Module **Conditions:** - Healthy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Thin arm is JLP-2004 FAST condition **Intervention Names:** - Drug: JLP-2004 qd **Label:** JLP-2004 FAST **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Thin arm is JLP-2004 FED condition **Intervention Names:** - Drug: JLP-2004 qd **Label:** JLP-2004 FED **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - JLP-2004 FAST - JLP-2004 FED **Description:** Group I(Peroid I-JLP-2004 FAST, Peroid II-JLP-2004 FED), Group II(Period I-JLP-2004 FED, Period II-JLP-2004 FAST) **Name:** JLP-2004 qd **Other Names:** - painkiller **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** AUCt of JLP-2004 in FAST and FED condition **Measure:** AUCt of JLP-2004 **Time Frame:** after treatment 0hour, 0.5hour, 1hour, 2hour, 3hour, 24hour **Description:** Cmax of JLP-2004 in FAST and FED condition **Measure:** Cmax of JLP-2004 **Time Frame:** after treatment 0hour, 0.5hour, 1hour, 2hour, 3hour, 24hour ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Healthy adult volunteers aged 19 years or older at the time of screening 2. At the time of screening, those who weigh more than 50.0 kg and have a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less. 3. Those who do not have congenital or chronic diseases and have no pathological symptoms or findings as a result of internal medical examination (if necessary, electroencephalography, electrocardiogram, chest and stomach endoscopy, or gastrointestinal radiography) 4. Those who be considered suitable for clinical subjects according to the results of laboratory tests (hematology tests, blood chemistry tests, urine tests, serum tests, blood coagulation tests, urine drugs tests), physical examinations and 12-lead electrocardiography at the time of screening 5. Those who voluntarily decide to participate and agree in writing to comply with the subject compliance requirements during the clinical trial period after receiving a detailed explanation of this clinical trial and fully understanding it Exclusion Criteria: 1. Those who have current or past medical history of clinically significant liver, kidney, nervous system, mental, respiratory, endocrine, blood disease, tumor, genitourinary, cardiovascular, digestive, and musculoskeletal systems, as well as the following symptoms or history. ① Renal impairment ② Liver disorder 2. For women, pregnant women (Urine-HCG positive) or breastfeeding mother 3. Those who have clinically significant hypersensitivity reactions such as asthma, hives, allergies, etc. to the main ingredient (Pelubiprofen), additives, or other drugs (aspirin or other non-steroidal anti-inflammatory drugs (including COX-2 inhibitors)) and have a history of hypersensitivity reaction 4. Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 5. Those with a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of clinical trial drugs **Healthy Volunteers:** True **Minimum Age:** 19 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** DAJIN KIM **Phone:** 043-269-6781 **Role:** CONTACT #### Locations **Location 1:** **City:** Chungju **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** DAJIN KIM - **Phone:** 043-269-6781 - **Role:** CONTACT **Country:** Korea, Republic of **Facility:** Chungbuk National University Hospital **State:** Seowon-gu **Status:** RECRUITING **Zip:** 28644 #### Overall Officials **Official 1:** **Affiliation:** Chungbuk National University Hospital **Name:** Minkyu Park **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4032 - Name: Analgesics - Relevance: HIGH - As Found: Ipca ### Intervention Browse Module - Meshes - ID: D000000700 - Term: Analgesics ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431386 **Brief Title:** Behavioural Activation Therapy and Esketamine for Resistant Depression **Official Title:** Optimizing the Synergy Between Behavioural Activation Therapy and Esketamine for Resistant Depression #### Organization Study ID Info **ID:** REB 2024002 #### Organization **Class:** OTHER **Full Name:** The Royal's Institute of Mental Health Research ### Status Module #### Completion Date **Date:** 2026-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** 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:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The Royal's Institute of Mental Health Research #### Responsible Party **Investigator Affiliation:** The Royal's Institute of Mental Health Research **Investigator Full Name:** Dr. Jeanne Talbot **Investigator Title:** Physician Scientist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is a randomized clinical trial to test the effectiveness of combining a proven psychological intervention called behavioural activation therapy alongside esketamine treatment for treatment resistant major depressive episodes in individuals with major depressive disorder or bipolar disorder. Encouraging participants to practice new behaviours while their mood is improved through esketamine treatment may lead to more lasting recovery from depression. **Detailed Description:** Depression is the leading cause of disability in the world and current treatments with medication are limited. Over one-third of individuals with major depressive disorder (MDD) and one quarter of individuals with bipolar disorder (BD) do not benefit from traditional pharmacotherapies, leading to treatment-resistant depressive episodes. Individuals with treatment-resistant depressive episodes (defined as a suboptimal response to two or more appropriate trials of antidepressant medication) have a higher burden of illness, higher healthcare utilization, poorer quality of life, worse occupational and social outcomes, and are at greater risk of death. Treatment-resistance may increase an individual's likelihood of engaging in suicidal behaviours and an estimated 30 percent of individuals with treatment-resistant depressive episodes will have a suicide attempt in their lifetime. To address these gaps in treatment, there has been growing interest in the use of intravenous (IV) ketamine as well as its newly marketed stereoisomer, esketamine, which is delivered intranasally. The discovery of the rapid antidepressant effects of low doses of ketamine has been hailed as a paradigm shift in psychiatry. However, a remaining challenge to address is the temporary nature of its effects. Ketamine induces neuroplasticity-enhancing effects more than conventional medications for depression. There may be the potential to harness this window of neuroplasticity to facilitate more lasting cognitive and/or behavioural changes through psychotherapy. To date, there are no randomized clinical trials of combined treatment with esketamine and psychotherapy for treatment-resistant depressive episodes. Studies to ensure that individuals can maximally benefit from this novel treatment are needed. The overall goal of this project is to maximize and sustain the beneficial effects of esketamine through combined treatment with behavioural activation (BA) therapy. The central hypothesis is that combined esketamine and BA therapy will elicit larger and faster decrease in depressive symptoms and more improvement in functional recovery compared with esketamine treatment alone. The specific aims of this research study are as follows: Aim 1. To determine if there is a larger decrease in depressive symptoms in participants receiving BA concurrent with esketamine treatment compared to participants receiving esketamine alone. Aim 2. To compare the speed of antidepressant response in participants receiving BA concurrent with esketamine treatment compared to participants receiving esketamine alone. Aim 3. To assess if participants receiving BA concurrent with esketamine treatment perceive greater improvement in functioning (self-reported depressive symptoms, quality of life, anhedonia, hopelessness, and work and social functioning) compared to participants receiving esketamine alone. This study is a single-site, parallel-arm, randomized clinical trial investigating the effects of augmenting esketamine treatment with BA therapy, an empirically supported treatment for depression. Participants will be randomized to one of two groups: 1) concurrent esketamine and BA therapy started from treatment initiation, or 2) esketamine treatment alone. Esketamine treatment will be offered as treatment as usual. All study participants will be offered a 12 session course of BA therapy, half will be randomized to receive BA concurrently with their esketamine treatment from initiation. Participants randomized to the esketamine treatment alone arm will be offered a full course of BA sessions after week 12 during the maintenance phase of treatment or at the time esketamine treatment ceases, whichever is earlier. BA therapy will be delivered virtually or in person according to participant preference (mode of administration will be recorded and included in data analysis as appropriate). The aim of BA therapy is to help individuals learn to observe the relationship between what they did, felt, and thought and what was happening around them, and to identify conditions which maintained, increased, or weakened maladaptive behaviours. Functional behaviour analysis will be used in problem and behaviour evaluation and in planning and reviewing changes introduced by participants between sessions. Other techniques include self-observation and self-report, elaboration of activity hierarchies, behaviour programming, rehearsal and behavioural modelling, and contingency management. Between-session homework will develop relevant and rewarding day-to-day routines liable to offer reinforcement in each participant's environment. An independent expert will assess the quality and adherence to BA for the trial. This will be the first clinical trial to test the concurrent use of esketamine and a behavioural intervention. The efficacy data for esketamine largely comes from randomized controlled trials and thus may not always reflect the clinical reality for individuals who present for treatment in hospital settings. Conducting research with esketamine in a naturalistic academic-hospital setting will inform clinical practice. The goal is to offer esketamine to individuals as part of a comprehensive treatment plan to help them achieve longer-term recovery as opposed to short-lived decrease in clinical symptoms. ### Conditions Module **Conditions:** - Depressive Disorder, Treatment-Resistant - Depressive Disorder, Major - Bipolar Disorder **Keywords:** - Major Depressive Disorder - Esketamine - Psychotherapy - Behavioural Activation - Bipolar Depression ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This pilot study is a single-site, parallel-arm, randomized clinical trial. ##### Masking Info **Masking:** SINGLE **Masking Description:** Clinical outcome assessments will be performed by raters blind to treatment allocation and not the treating therapist or physician. Ratings will be acquired prior to treatment administration. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants randomized to this arm will be administered esketamine treatment as per standard clinical care in conjunction with behavioural activation (BA) therapy. Both treatments will be initiated in Week 1 of the induction phase (first 4 weeks of esketamine treatment). **Intervention Names:** - Behavioral: Behavioural Activation (BA) Therapy - Drug: Esketamine **Label:** Esketamine + Behavioural Activation Therapy **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants randomized to this arm will be administered esketamine treatment as per standard clinical care and will be offered a course of BA therapy (12 one hour sessions) after their completion of the trial. **Intervention Names:** - Drug: Esketamine **Label:** Esketamine Alone **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Esketamine + Behavioural Activation Therapy **Description:** Participants will receive weekly one-hour BA sessions on a day they are not receiving esketamine, delivered virtually or in person as per participant preference. The aim is for participants to learn to observe the relationship between what they did, felt, and thought and what was happening around them, and to identify conditions which maintained, increased, or weakened maladaptive behaviours. Functional behaviour analysis will be used in problem and behaviour evaluation and in planning and reviewing changes introduced by participants between sessions. Other techniques include self-observation and self-report, elaboration of activity hierarchies, behaviour programming, rehearsal and behavioural modelling, and contingency management. Between-session homework will develop relevant and rewarding routines to offer reinforcement in each participant's environment. Participants will be offered 12 BA sessions in total. **Name:** Behavioural Activation (BA) Therapy **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Esketamine + Behavioural Activation Therapy - Esketamine Alone **Description:** Participants will receive intranasal esketamine twice weekly during the induction phase (first 4 weeks of treatment). Maintenance treatments are administered once per week or once every two weeks at the discretion of the treating physician for 8 additional weeks, totaling 12 weeks of esketamine treatment. Dosing for esketamine usually starts at 56mg on Day 1, followed by 56 or 84mg doses for subsequent treatments. **Name:** Esketamine **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score **Measure:** Change in depressive symptoms **Time Frame:** Baseline to the end of the induction phase (week 4); additional efficacy assessment time points will include end of weeks 2, 8 and 12 #### Secondary Outcomes **Description:** Time required to first meet response criteria (≥50% improvement in MADRS scores) **Measure:** Speed of therapeutic effects **Time Frame:** Induction phase (weeks 1-4) **Description:** Change in self-reported depressive symptoms, quality of life, anhedonia, hopelessness, and physical, emotional and social functioning **Measure:** Change in participant perceived functioning **Time Frame:** Baseline to end of induction phase (week 4), and the end of weeks 8 and 12 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * English speaking * Ages 18-65 * Participants meeting criteria for major depressive disorder (MDD) or bipolar disorder, depressive episode without psychotic symptoms according to the Diagnostic and Statistical Manual for Mental Disorders (DSM-5). * Participants who have not responded adequately to at least two separate courses of treatment with different antidepressants, each of adequate dose and duration, in the current moderate to severe depressive episode. Exclusion Criteria: * Depression secondary to a stroke, cancer, or other severe medical illnesses. * Pregnant, lactating or of childbearing potential and unwilling to use an approved method of contraception during the study. * A history of intracerebral hemorrhage, vascular disease. * Active psychotic symptoms. * Current and/or recent history (\<12 months) of substance use/dependence (except for caffeine or nicotine) or problematic current alcohol use or dependence as defined by DSM-5 criteria. * A diagnosis of major neurocognitive disorder or a Montreal Cognitive Assessment (MOCA) score \<24. * Active suicidal intent with the absence of psychotic symptoms is not an exclusion criterion, as this is not atypical in individuals with treatment-resistant, and/or severe depression (safety monitoring will be carried out by research personnel/study psychiatrists). * Known history of intolerance or hypersensitivity to ketamine. * Any other condition that, in the opinion of the PI/study investigator(s), would adversely affect the participant's ability to complete the study or its measures. * The participant must not be receiving psychotherapy treatment outside the clinical trial for the duration of the study. **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:** Research Coordinator **Phone:** 613-722-6521 **Phone Ext:** 6934 **Role:** CONTACT #### Locations **Location 1:** **City:** Ottawa **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Research Coordinator - **Phone:** 613-722-6521 - **Phone Ext:** 6934 - **Role:** CONTACT ***Contact 2:*** - **Name:** Jeanne Talbot, MD PhD FRCP - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Jennifer Phillips, PhD - **Role:** SUB_INVESTIGATOR **Country:** Canada **Facility:** The Royal Ottawa Mental Health Centre **State:** Ontario **Status:** RECRUITING **Zip:** K1Z 7K4 #### Overall Officials **Official 1:** **Affiliation:** The Royal's Institute of Mental Health Research **Name:** Jeanne Talbot, MD PhD FRCP **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000068105 - Term: Bipolar and Related 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: HIGH - As Found: Depressive Disorder - ID: M7060 - Name: Depressive Disorder, Major - Relevance: HIGH - As Found: Depressive Disorder, Major - ID: M4996 - Name: Bipolar Disorder - Relevance: HIGH - As Found: Bipolar Disorder - ID: M29783 - Name: Depressive Disorder, Treatment-Resistant - Relevance: HIGH - As Found: Depressive Disorder, Treatment-Resistant - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M226 - Name: Bipolar and Related Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003863 - Term: Depression - ID: D000003866 - Term: Depressive Disorder - ID: D000001714 - Term: Bipolar Disorder - ID: D000003865 - Term: Depressive Disorder, Major - ID: D000061218 - Term: Depressive Disorder, Treatment-Resistant ### Intervention Browse Module - Ancestors - ID: D000000928 - Term: Antidepressive Agents - ID: D000011619 - Term: Psychotropic Drugs ### Intervention Browse Module - Browse Branches - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M271980 - Name: Esketamine - Relevance: HIGH - As Found: Hrs - ID: M4247 - Name: Antidepressive Agents - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000629870 - Term: Esketamine ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431373 **Acronym:** CLARITY **Brief Title:** A Study of Brepocitinib in Adults With Active, Non-Infectious, Non-Anterior Uveitis (CLARITY) **Official Title:** A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Active, Non-Infectious Intermediate-, Posterior-, and Panuveitis #### Organization Study ID Info **ID:** PVT-2201-303 #### Organization **Class:** INDUSTRY **Full Name:** Priovant Therapeutics, Inc. ### Status Module #### Completion Date **Date:** 2027-08-23 **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:** 2026-08-23 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-23 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Priovant 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:** The purpose of this study is to determine the safety and efficacy (including corticosteroid-sparing effect) of brepocitinib in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis (NIU). ### Conditions Module **Conditions:** - Uveitis, Posterior - Uveitis, Intermediate - Uveitis ### 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:** 220 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Brepocitinib 45 mg PO QD **Label:** Arm 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Placebo PO QD **Label:** Arm 2 **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Arm 1 **Description:** Brepocitinib 45 mg PO QD **Name:** Brepocitinib 45 mg PO QD **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Arm 2 **Description:** Placebo PO QD **Name:** Placebo PO QD **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Proportion of participants meeting treatment failure criteria on or after Week 6 up to Week 24 **Time Frame:** 24 weeks #### Secondary Outcomes **Measure:** Time to treatment failure on or after Week 6 up to Week 24 **Time Frame:** 24 weeks **Measure:** Change in logarithm of the minimum angle of resolution (logMAR) best corrected visual acuity (BCVA) in each eye from best state achieved at Week 6 up to Week 24 **Time Frame:** 24 weeks **Measure:** Change in central subfield thickness from best state achieved in each eye at or prior to Week 6 up to Week 24 **Time Frame:** 24 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult subjects (18-74 years old) * Diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, or panuveitis). * Active uveitic disease as defined by the presence of at least 1 of the following parameters in at least 1 eye, as determined by the investigator: Active, inflammatory chorioretinal and/or retinal vascular lesion; OR ≥2+ vitreous haze grade (NEI/SUN criteria). * Weight \> 40 kg with a body mass index \< 40 kg/m2. Exclusion Criteria: * Has isolated anterior uveitis. * Has macular edema as the only sign of intermediate uveitis, posterior uveitis, or panuveitis. * Has confirmed or suspected current diagnosis of infectious uveitis * History of or have: 1. ymphoproliferative disorder 2. active malignancy; 3. cancer within 5 years prior to screening (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.) 4. thrombosis and cardiovascular disease within the last 12 months 5. a high risk for herpes zoster reactivation 6. active or recent infections **Maximum Age:** 74 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014603 - Term: Uveal Diseases - ID: D000005128 - Term: Eye Diseases - ID: D000015864 - Term: Panuveitis - ID: D000002833 - Term: Choroiditis - ID: D000015862 - Term: Choroid Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M17353 - Name: Uveitis - Relevance: HIGH - As Found: Uveitis - ID: M18410 - Name: Uveitis, Posterior - Relevance: HIGH - As Found: Uveitis, Posterior - ID: M18411 - Name: Uveitis, Intermediate - Relevance: HIGH - As Found: Uveitis, Intermediate - ID: M18408 - Name: Panuveitis - Relevance: LOW - As Found: Unknown - ID: M18412 - Name: Pars Planitis - Relevance: HIGH - As Found: Uveitis, Intermediate - ID: M17351 - Name: Uveal Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: M6073 - Name: Choroiditis - Relevance: LOW - As Found: Unknown - ID: M18406 - Name: Choroid Diseases - Relevance: LOW - As Found: Unknown - ID: T4396 - Name: Panuveitis - Relevance: LOW - As Found: Unknown - ID: T4439 - Name: Pars Planitis - Relevance: HIGH - As Found: Uveitis, Intermediate - ID: T5824 - Name: Uveal Diseases - Relevance: LOW - As Found: Unknown - ID: T1187 - Name: Choroiditis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014605 - Term: Uveitis - ID: D000015866 - Term: Uveitis, Posterior - ID: D000015867 - Term: Uveitis, Intermediate - ID: D000015868 - Term: Pars Planitis ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431360 **Brief Title:** Effect of Strontium-90 Brachytherapy Combined With Hyperthermia in the Treatment of Keloid **Official Title:** Effect of Strontium-90 Brachytherapy Combined With Hyperthermia in the Treatment of Keloid #### Organization Study ID Info **ID:** KY20240514-02 #### Organization **Class:** OTHER **Full Name:** Nanjing First Hospital, Nanjing Medical University ### Status Module #### Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-14 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Nanjing First Hospital, Nanjing Medical University #### Responsible Party **Investigator Affiliation:** Nanjing First Hospital, Nanjing Medical University **Investigator Full Name:** Feng Wang **Investigator Title:** Director of nuclear medicine department **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Keloid patients were randomized into the experimental and control groups. Experimental group: Strontium-90 (Sr-90) brachytherapy followed by hyperthermia. Control group: Sr-90 brachytherapy alone . **Detailed Description:** Sr-90 brachytherapy: 6-7 Gy each time, twice a week for 3 weeks; Hyperthermia: using a heater, 44℃ for 15 min ### Conditions Module **Conditions:** - Keloid ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Sr-90 brachytherapy followed by hyperthermia. **Intervention Names:** - Other: hyperthermia **Label:** Experimental group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Sr-90 brachytherapy alone. **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental group **Description:** hyperthermia (using a heater, 44℃for 15 min) **Name:** hyperthermia **Other Names:** - heater **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability and surface area). All items are scored on a scale ranging from 1 ('like normal skin') to 10 ('worst scar imaginable'). The sum of the six items results in a total score of the POSAS observer scale. Categories boxes are added for each item. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10. All parameters should preferably be compared to normal skin on a comparable anatomic location. comparable anatomic location. **Measure:** Patient and Observer Scar Assessment Scale (POSAS) scores **Time Frame:** once every 3 months for 1 year after the last treatment **Description:** Physician evaluation comprised the use of the Vancouver Scar Scale (VSS) to evaluate the pigmentation (0=normal, 1=hypopigmented, 2=hyperpigmented), pliability (0=normal, 1= supple, 2=yielding, 3=firm, 4=banding, 5=contracture), height (0= flat, 1=5 mm), and vascularity (0=normal, 1=pink, 2=pink to red, 3=red, 4=red to purple, 5=purple). **Measure:** Vancouver Scar Scale (VSS) scores **Time Frame:** once every 3 months for 1 year after the last treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * The patient was clinically diagnosed with keloid, and the keloid area was clean without rupture and exudation； * Body surface keloid thickness: 2\~5mm, diameter ≥10mm. Exclusion Criteria: * Women who plan to become pregnant within 3 months or are pregnant or breastfeeding; * Patients with cicatricial constitution; * Abnormal coagulation function; * Patients who have received an adequate dose or course of radiation therapy; * People with previous immune system diseases, diabetes and other metabolic diseases. **Maximum Age:** 75 Years **Minimum Age:** 16 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Feng Wang **Phone:** 86-025-52271455 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Liang Shi **Phone:** 86-025-52271491 **Role:** CONTACT #### Locations **Location 1:** **City:** Nanjing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Feng Wang, Ph.D. - **Phone:** 86-025-52271455 - **Role:** CONTACT **Country:** China **Facility:** Nanjing First Hospital **State:** Jiangsu **Status:** RECRUITING **Zip:** 210006 **Location 2:** **City:** Nanjing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Feng Wang - **Phone:** 86-025-52271455 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Liang Shi - **Phone:** 86-025-52271491 - **Role:** CONTACT **Country:** China **Facility:** The First Affiliated Hospital of Nanjing Medical Univerity **State:** Jiangsu **Status:** RECRUITING **Zip:** 210006 #### Overall Officials **Official 1:** **Affiliation:** Nanjing First Hospital, Nanjing Medical University **Name:** Feng Wang **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001832 - Term: Body Temperature Changes - ID: D000018882 - Term: Heat Stress Disorders - ID: D000014947 - Term: Wounds and Injuries - ID: D000003095 - Term: Collagen Diseases - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000002921 - Term: Cicatrix - ID: D000005355 - Term: Fibrosis - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC05 - Name: Musculoskeletal Diseases ### Condition Browse Module - Browse Leaves - ID: M2454 - Name: Hyperthermia - Relevance: HIGH - As Found: Hyperthermia - ID: M8464 - Name: Fever - Relevance: LOW - As Found: Unknown - ID: M10654 - Name: Keloid - Relevance: HIGH - As Found: Keloid - ID: M5111 - Name: Body Temperature Changes - Relevance: LOW - As Found: Unknown - ID: M20924 - Name: Heat Stress Disorders - Relevance: LOW - As Found: Unknown - ID: M24916 - Name: Stress Disorders, Traumatic - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M6160 - Name: Cicatrix - Relevance: LOW - As Found: Unknown - ID: M8485 - Name: Fibrosis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007627 - Term: Keloid - ID: D000084462 - Term: Hyperthermia ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431347 **Brief Title:** Prospective Observational Cohort Study of Transplant and Cell Therapy Candidates and Recipients to Assess Social Determinants of Health **Official Title:** Prospective Observational Cohort Study of Transplant and Cell Therapy Candidates and Recipients to Assess Social Determinants of Health #### Organization Study ID Info **ID:** 2024-0038 #### Organization **Class:** OTHER **Full Name:** M.D. Anderson Cancer Center #### Secondary ID Infos **Domain:** NCI-CTRP Clinical Registry **ID:** NCI-2024-04536 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2029-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-11-29 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** M.D. Anderson Cancer Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** To learn more about social and financial factors that may influence outcomes of TCT treatment at MD Anderson. **Detailed Description:** Primary Objective: To determine the relationship between participant social determinants of health (SDOH) and outcomes following transplantation and cellular therapy at MDACC. ### Conditions Module **Conditions:** - Transplant and Cell Therapy **Keywords:** - Social Determinants of Health ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 2000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants that agree to take part in this study, the study staff will first verify your demographic information (such as age, sex, race, and so on). Participants will then be asked about social barriers to care, including but not limited to: * primary language and confidence speaking English * education level * employment history * health literacy * legal history * caregiver status and literacy **Intervention Names:** - Behavioral: Social Determinants of Health Questionnaire **Label:** Transplant and Cell Therapy Candidates and Recipients ### Interventions #### Intervention 1 **Arm Group Labels:** - Transplant and Cell Therapy Candidates and Recipients **Description:** Participants will also complete a questionnaire about financial barriers to care within the past year, including income bracket and difficulty affording cost-of-living or medical expenses. **Name:** Social Determinants of Health Questionnaire **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Measure:** Social Determinants of Health Questionnaire **Time Frame:** At 6, 12, 18, and 24 months post Transplant and Cell Therapy ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria 1. ≥ 18 years of age. 2. Received financial clearance for TCT. Exclusion Criteria 1) Did not receive financial clearance for TCT **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** MD Anderson Cancer Center ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Warren Fingrut, MD **Phone:** (832) 387-8363 **Role:** CONTACT #### Locations **Location 1:** **City:** Houston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Warren Fingrut, MD - **Phone:** 832-387-8363 - **Role:** CONTACT ***Contact 2:*** - **Name:** Warren Fingrut, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** MD Anderson Cancer Center **State:** Texas **Zip:** 77030 #### Overall Officials **Official 1:** **Affiliation:** M.D. Anderson Cancer Center **Name:** Warren Fingrut, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### See Also Links **Label:** MD Anderson Cancer Center **URL:** http://www.mdanderson.org ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431334 **Brief Title:** Protein Requirements Amongst Male Masters-Level Athletes Following a Cycling Exercise Bout as Determined by the Indicator Amino Acid Oxidation Technique **Official Title:** Protein Requirements Amongst Male Masters-Level Athletes Following a Cycling Exercise Bout as Determined by the Indicator Amino Acid Oxidation Technique #### Organization Study ID Info **ID:** A06-M25-23A #### Organization **Class:** OTHER **Full Name:** McGill University ### Status Module #### Completion Date **Date:** 2025-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** McGill University #### Responsible Party **Investigator Affiliation:** McGill University **Investigator Full Name:** Tyler Churchward-Venne **Investigator Title:** Assistant Professor of Exercise Physiology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Masters level cyclists are a population above the age of 35 years who frequently participate in prolonged as well as heavy-volume training. Like most endurance-trained athletes, a greater recommended dietary allowance (RDA) for protein of 1.2-1.4 g/kg/bw is suggested. Dietary protein intake is vital for maximizing the benefits of training and ensuring optimal recovery. Dietary recommendations traditionally have been determined through nitrogen balance techniques, however, recent research indicates how this method is potentially underestimating protein requirements. Therefore, there is a need to reassess current dietary recommendations in order to meet the demands of physical activity for highly active populations. Recent efforts to understand protein requirements during rest and following exercise have been completed using the indicator amino acid technique (IAAO). This non-invasive method is reported to provide a robust measure of protein requirements. However, there is limited work in older (≥60 years) active populations. The purpose of this study is to measure the protein requirements in master cyclists, following an endurance training session, using the non-invasive IAAO technique. ### Conditions Module **Conditions:** - Healthy - Increased Metabolic Requirements - Dietary Reference Intakes ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 8 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants are to be randomly assigned varying levels of amino acid intakes ranging between 0.5 to 2.8 g/kg/d **Intervention Names:** - Dietary Supplement: Amino Acid Intake **Label:** Masters Level Cyclists **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Masters Level Cyclists **Description:** Amino acid intakes will vary between 0.5 to 2.8 g/kg/d **Name:** Amino Acid Intake **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Measured by continuous-flow isotope ratio mass spectrometry **Measure:** 13CO2 Excretion **Time Frame:** 7-weeks #### Secondary Outcomes **Description:** Measured by gas chromatography-mass spectrometry **Measure:** L[13C]phenylalanine Oxidation **Time Frame:** 7-weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18.5\< BMI \<35 kg/m\^2 * Overtly healthy masters level cyclists ≥65 years * Masters level cyclist training (\>4 days per week; \~100 km per week) * Body mass stable over previous 6-months * Availability for multiple metabolic trials (\~7 trials) * Ability to travel to and from laboratory facility Exclusion Criteria: * Recent history of weight loss or weight gain (\>5% body weight) * Uncontrolled hypertension * ≥2 chronic diseases (e.g. diabetes, osteoporosis, dyslipidemia) * Acute illness that could affect protein metabolism (HIV, renal dysfunction, influenza) * Currently using anti-inflammatory medications * Inability to adhere to study protocol (i.e., alcohol, caffeine, dietary restrictions) * Regular tobacco user * Illicit drug use * Habitually ingesting ≥3 g/kg/bw **Healthy Volunteers:** True **Minimum Age:** 65 Years **Sex:** MALE **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Tyler A. Churchward-Venne, Ph.D. **Phone:** (514) 398-4184 **Phone Ext:** 00839 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Zachary Bell, Ph.D **Phone:** (514) 296-6960 **Role:** CONTACT #### Locations **Location 1:** **City:** Montréal **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Zachary W Bell, PhD - **Phone:** 5142966960 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Tyler A Churchward-Venne, PhD - **Phone:** 5147938920 - **Role:** CONTACT ***Contact 3:*** - **Name:** Zachary W Bell, PhD - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Tyler A Churchward-Venne, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 5:*** - **Name:** Micaela Forcione, BSc - **Role:** SUB_INVESTIGATOR **Country:** Canada **Facility:** McGill University **State:** Quebec **Zip:** H3A 0G4 ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431321 **Brief Title:** Evaluation of a 2-session Parent Training Programme for Caregivers of Younger Children in Zimbabwe **Official Title:** A Pilot Cluster Randomised Controlled Trial of a Two-session Parent Training Programme for Delivery to Caregivers of Children Enrolled in Early Childhood Development in Harare, Zimbabwe #### Organization Study ID Info **ID:** WNDNOR001 #### Organization **Class:** OTHER **Full Name:** University of Cape Town ### Status Module #### Completion Date **Date:** 2024-09-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-08-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Parenting for Lifelong Health **Class:** UNKNOWN **Name:** Mikhulu Trust **Class:** UNKNOWN **Name:** Clowns Without Borders South Africa **Class:** UNKNOWN **Name:** Ministry of Primary and Secondary Education Zimbabwe #### Lead Sponsor **Class:** OTHER **Name:** University of Cape Town #### Responsible Party **Investigator Affiliation:** University of Cape Town **Investigator Full Name:** Noreen Wini Dari **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:** A pilot, exploratory cluster Randomised Controlled Trial (RCT) with two arms will be conducted to test a two-session parent training programme for caregivers of children enrolled in early childhood development classes in Harare Zimbabwe. The Parenting for Lifelong Health programme for Young Children together with the Mikhulu Trust Book Sharing Programme for Young Children will be adapted into a two-session version programme named Tabudirira Parent Training Intervention for Early Childhood Development. The RCT aims to assess the following objectives: Can the programme reduce child maltreatment? Does the intervention improve parent-child engagement with reading material? How best can the 2-session programme delivery be optimised? **Detailed Description:** A pilot, exploratory cluster Randomised Controlled Trial (RCT) with two arms will be conducted to test a two-session parent training programme for caregivers of children enrolled in early childhood development classes in Harare, Zimbabwe. The Parenting for Lifelong Health programme for Young Children together with the Mikhulu Trust Book Sharing Programme for Young Children will be adapted into a two-session version programme named Tabudirira Parent Training Intervention for Early Childhood Development. The RCT aims to assess the following objectives: Can the programme reduce child maltreatment? Does the intervention improve parent-child engagement with reading material? How best can the 2-session programme delivery be optimised? The RCt will have 2 arms with 120 caregivers /arms. The intervention will be a 2-session parent training programme while the control is a 2-session nutrition knowledge dissemination workshop delivered over 2 sessions. ### Conditions Module **Conditions:** - Child Maltreatment **Keywords:** - Child Maltreatment - Parenting - Violence Against Children (VAC) - Prevention - Parenting Intervention - Early Childhood Development (ECD) ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Each study arm will have 8 schools Schools will be randomly assigned to the study arm ##### Masking Info **Masking:** DOUBLE **Masking Description:** Research assistants and the statistician will be blinded until the analyses are completed. The randomisation process is concealed from research assistants in order to avoid experimenter bias. Complete statistical analysis plans will be prepared before the data is locked, and analysis tactics are predetermined. Until the data are finalised, the study statistician will not be aware of the treatment assignment **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 240 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The Tabudirira Parenting Intervention for Early Childhood Development will be delivered to parents of children aged 4-5 years in Harare, Zimbabwe. Trained facilitators will deliver the programme face to face, and a group of 15 parents will have 3 facilitators. The facilitators comprise of teachers working as guidance and counselling coordinators and psychology graduates. The programme consists of 2 sessions that will be delivered once a week over 2 weeks, with each session lasting 2.5 to 3 hours. The session will have various activities which focus on learning from each other and practising positive parenting behaviours. At the end of each session, parents will receive a home activity which allows them to practise the content taught during the session. At the end of session 2 parents will receive a parent handbook with the summary of the 2 sessions. Schools will be used as venues and the facilitators will receive ongoing mentoring and coaching during programme delivery. **Intervention Names:** - Behavioral: Tabudira Parenting Intervention for Early Childhood Development **Label:** Parent training intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The control group (8 groups with 15 parents each) will receive a one-hour session on nutrition with facilitators trained by a nutritionist focusing on children aged 4-7 years. The parents will also receive a nutrition handbook. Zimbabwe is faced with the triple burden of malnutrition: underweight, micronutrient deficiencies and overweight. There is an ongoing need to protect and promote diets, services and practices through a multi-systems approach that supports optimal nutrition, growth, and development for all children, using a parent support group can help achieve the goal. The nutrition programme has no components of positive parenting or links to the reduction of violence against children but will serve as a placebo control for the attention received by parents. **Intervention Names:** - Other: Nutritional guide for younger children **Label:** Control **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Parent training intervention **Description:** 2 session programme delivered weekly over 2 weeks using group-based delivery aimed at reducing child maltreatment, improving parenting behaviours and parent's mental health. **Name:** Tabudira Parenting Intervention for Early Childhood Development **Other Names:** - Parenting for Lifelong Health Young Children combined with Mikhulu Trust Book Sharing Programme - 2-Session Version **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Control **Description:** 2 session programme delivered weekly over 2 weeks aimed at providing parents with nutritional education to help provide maximum nutrition to the growing child **Name:** Nutritional guide for younger children **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Barriers and enablers to delivery Barriers and enablers to parent engagement (attendance, homework completion) **Measure:** Implementation Outcomes **Time Frame:** 6 weeks #### Primary Outcomes **Description:** The International Child Abuse Screening Tool-Trial version (ICAST-T) measures the occurrence of respondents' discipline behaviour towards the child **Measure:** Changes in frequency of child maltreatment: **Time Frame:** 6 weeks #### Secondary Outcomes **Description:** Changes in attitudes towards harsh parenting will be measured using two items from the ICAST-T measure used in measuring the primary outcome. The questions will seek to understand parental attitudes towards harsh discipline for example: In the past 6 weeks, how often did physical discipline seem like the only option for stopping bad behaviour? **Measure:** Changes in attitudes towards harsh parenting **Time Frame:** 6 weeks **Description:** will be measured using 1 item from the ICAST-T the question: In the past 6 weeks, how often did you not know what to do when your child misbehaved **Measure:** Changes in not knowing what to do when a child misbehaves **Time Frame:** 6 weeks **Description:** The Parenting Young Children Questionnaire (PARYC) has 9 items that contain statements of parenting behaviours that caregivers rate on a Likert scale from 1 (not at all) to 7 (most of the time). Two dimensions of the PARYC will be measured: Supporting Good Behaviour (e.g., "Notice/Praise good behaviour") and Setting Limits (e.g., "Stick to your rules"). The items included in the current questionnaire (Cronbach alpha 0.86). are informed by the metric invariance analysis of the measure done in a preceding study, pending publication. The preceding study measured the prevalence of violence against children and its correlates. The highest possible score is 63 indicating more parent-child engagement compared to the lowest possible score of 9 indicating fewer parent-child engagements. **Measure:** Spending time with child, praising, naming emotions **Time Frame:** 6 weeks **Description:** Two items, similar in structure to those in the PARYC, will be used to assess this e.g. How often do you spend time book sharing with your child? **Measure:** Changes in time spent engaging the child in book sharing **Time Frame:** 6 weeks **Description:** The Shona Symptoms Questionnaire (SSQ-14) will be used to assess parental mental health before and after the programme. The SSQ is a 14-item screening tool for common mental disorders and has a reliable internal consistency (0.85). It asks about symptoms such as thinking too much, failing to concentrate, work lagging, insomnia, suicidal ideation, unhappiness and so on, over 1 week. Highest total possible score of 14 indicates floundering parental mental health while a score of 0 indicates flourishing parental mental health **Measure:** Changes in caregiver mental health **Time Frame:** 6 weeks **Description:** The Multidimensional Measure of Work-Family Conflict (MMWFC) measures work-family conflict on three constructs: time, strain and behaviour. The scale has 12 items, with responses on a 7-point Likert scale ranging from strongly disagree to strongly agree. The following are examples of items in the questionnaire: my work keeps me from my family activities more than I would like, I am often stressed from my family responsibilities, and I have a hard time concentrating on my work. The internal reliability was 0.92 in phase 1. The highest possible score is 84 indicating increased work-family conflict compared to 12 which is the lowest possible score indicating better work-family balance. **Measure:** Changes in work-family conflict **Time Frame:** 6 weeks **Description:** : Four questions will be adapted from the Food and Agriculture Organisation of the United Nations guidelines for assessing nutrition-related knowledge, attitudes, and practices. The questions will assess the practices of the child's intake of healthy (2 items) and unhealthy snacks (2 items): How many times a day does your child eat candy? The items will be measured on a 6-point Likert scale ranging from Never to 6 times a day. The healthy eating scores will be reverse scored. The highest possible total is 24 indicating poor snacking practices compared to the lowest possible score of 4 for healthy snacking practices. **Measure:** Changes in Knowledge of Child nutrition **Time Frame:** 6 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged 18 years and above. * Be a caregiver to a child enrolled in Early Childhood Development Grade A at a school in Harare Northern Central School district. * Live with the child for a minimum of 5 days/ week. * Provide informed consent before any study proceedings. Exclusion Criteria * Aged below 18 * A child enrolled in a school outside Harare Northern Central School District * Child not enrolled in Early Childhood Development Grade A **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:** Noreen Wini Dari, MSc **Phone:** +263 718 886340 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Cathrine Ward, PhD **Phone:** +27 21 650 3422 **Role:** CONTACT #### Locations **Location 1:** **City:** Harare **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Marian Mazingi District Official: Ministry of Primary and secondary Education - **Phone:** +263 772 864 277 - **Role:** CONTACT **Country:** Zimbabwe **Facility:** Harare Northen Central School District #### Overall Officials **Official 1:** **Affiliation:** University of Capetown **Name:** Noreen Wini Dari, MSc **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Open **Description:** Ziva Hub Anonymised Individual Participant Data **Info Types:** - STUDY_PROTOCOL - SAP - ICF **IPD Sharing:** YES **Time Frame:** 2026 **URL:** https://zivahub.uct.ac.za/ ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21009 - Name: Micronutrients - Relevance: LOW - As Found: Unknown - ID: M16885 - Name: Trace Elements - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431308 **Brief Title:** Nutritional Therapy to Incretin-based Anti-obesity Medications in the Management of Gastrointestinal Adverse Events **Official Title:** Adjuvant Nutritional Therapy to Incretin-based Anti-obesity Medications in the Management of Gastrointestinal Adverse Events During the Up-titration Phase #### Organization Study ID Info **ID:** ASMC-0003-24 #### Organization **Class:** OTHER **Full Name:** Ariel University ### Status Module #### Completion Date **Date:** 2026-04-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-26 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-04-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-03-28 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ariel University #### Responsible Party **Investigator Affiliation:** Ariel University **Investigator Full Name:** Shiri Sherf Dagan **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of the study is to evaluate the effect of nutrition intervention on gastrointestinal symptoms, treatment discontinuation rate, nutritional parameters (e.g., dietary intake and eating habits), anthropometric measures, functional parameters, and QOL during the initiation and up-titration phase of incretin-based Anti Obesity Medications (AOM) treatment in patients with overweight/obesity. The nutrition intervention protocol will be developed based on literature review, focus groups with health care professionals, and patient interviews. A single-center pilot study will be performed at the Tel-Aviv Assuta Medical Center, among 10 patients who are about to initiate long-term weight management treatment with Wegovy© (semaglutide 2.4 mg), followed by a multi-center, parallel design open-label, RCT, which will be conducted at the Tel-Aviv Assuta Medical Center and Rabin Medical Center - Beilinson Hospital, in 120 patients who are about to initiate long-term weight management treatment with Wegovy©. The intervention group will receive nutrition guidance before AOM treatment by registered dietitian (RD) followed by nutrition and behavioral recommendations according to reported gastrointestinal symptom(s). The control group will receive the usual nutrition care for patients treated with AOM. Primary outcomes (gastrointestinal symptom assessment) and secondary outcomes (incretin-based AOM discontinuation rate, nutritional parameters, anthropometrics, functional parameters and QOL) will be evaluated by interviews, questionnaires and measurements at baseline, at the end of Wegovy© titration phase \[20 weeks (T1)\] and weekly during the study period (for GI symptoms assessment). ### Conditions Module **Conditions:** - Obesity; Drug ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Nutrition guidance before AOM treatment by registered dietitian (RD) followed by nutrition and behavioral recommendations according to reported gastrointestinal symptom(s). **Intervention Names:** - Behavioral: nutritional intervention **Label:** Nutritional intervention group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** * Usual nutrition care treatment for patients treated with Wegovy© (RCT). * Prior to the initiation of AOM treatment, participant will receive general nutrition guidance based on national recommendations according to the Mediterranean diet. **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Nutritional intervention group **Description:** A nutrition guidance before initiation of AOM treatment include recommendations for food choices and eating habits to minimize the occurrence and severity of GI symptoms during the up-titration phase, will be given by registered dietitian (RD) from the study team. Next, each week, participants will provide weekly reports of GI symptoms occurrence and severity, by responding to queries sent via WhatsApp/SMS and for occurring symptoms, an automatically structured nutrition and behavioral treatment recommendations will be sent. Three days after each report of GI symptom(s), participants will receive an additional message and will be asked to report the occurrence and severity of the GI symptom, and their compliance with the specific dietary instructions received. If participants expressed an interest in personalized dietary guidance on this matter, the study team RD will contact him/her by telephone, within a range of 48 hours, to provide individualized recommendations **Name:** nutritional intervention **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** Participants will be asked to provide at T0 biochemical tests obtained during the last 3 months, including complete blood count, lipid profile, fasting glucose, HbA1c, iron, transferrin, ferritin, vitamin B12, folate, and vitamin D **Measure:** Biochemical tests **Time Frame:** At baseline **Description:** years **Measure:** Demographics - age **Time Frame:** At baseline **Description:** married, single, divorced or widowed **Measure:** Demographics - marital status **Time Frame:** At baseline **Description:** less than high school, high school graduate, high school diploma, bachelors degree, masters degree, MD or doctoral degree **Measure:** Demographics - education **Time Frame:** At baseline **Description:** employee full time, employee part time, self-employed or other **Measure:** Demographics - occupation status **Time Frame:** At baseline **Description:** T2DM, prediabetes, dyslipidemia, HTN,sleep apnea, orthopedic problems, GERD, mental disorder or other **Measure:** Health status - Number of participants with coexisting medical conditions and their types **Time Frame:** Baseline and at the end of the study period (20 weeks) **Description:** usual medications **Measure:** Number of participants using regular medications and their types **Time Frame:** Baseline and at the end of the study period (20 weeks) **Description:** smoker, former smoker or never **Measure:** Smoking habits **Time Frame:** Baseline and at the end of the study period (20 weeks) **Description:** multiviamin, Iron, vitamin D, folic acid, vitamin B12, calcium or other **Measure:** Number of participants ysing supplementation and their Types **Time Frame:** Baseline and at the end of the study period (20 weeks) **Description:** sleeping quality on a scale of 0-3 (0- very good, 1-quite good, 2- quite bad, 3- very bad) **Measure:** Lifestyle factors - Sleeping habits **Time Frame:** Baseline and at the end of the study period (20 weeks) **Description:** number of exercises per week **Measure:** Lifestyle factors - frequency of physical activity **Time Frame:** Baseline and at the end of the study period (20 weeks) **Description:** exercise time in minutes **Measure:** Lifestyle factors - duration of physical activity **Time Frame:** Baseline and at the end of the study period (20 weeks) **Description:** aerobic or anaerobic **Measure:** Lifestyle factors - type of physical activity **Time Frame:** Baseline and at the end of the study period (20 weeks) #### Primary Outcomes **Description:** GI symptoms rating scale (GSRS) - assess the degree of specific GI complaints Every question is rated by seven graded Likert-type scale (1 represents the absence of troublesome symptoms and 7 represents very troublesome symptoms) while a higher score of the whole questionnaire and by dimension represents more severe symptoms. **Measure:** Gastrointestinal symptoms assessment **Time Frame:** Baseline and at the end of the study period (20 weeks) **Description:** Bristol stool scale - classifying the form of human feces into seven categories. Type 1-2 are considered abnormal hard stools and indicative of constipation type, and type 5-7 are considered abnormally loose/liquid stools and indicative of diarrhea or urgency **Measure:** Defecation texture **Time Frame:** Baseline and at the end of the study period (20 weeks) **Description:** will be assessed according to five acceptable categories: \>3 BMs/day, 2-3 BMs/day, 1-2 BMs/day, 3-4 BMs/week, \<3 BMs/week **Measure:** Bowel Movement (BM) frequency **Time Frame:** Baseline and at the end of the study period (20 weeks) **Description:** Participant subjective and objective reporting of GI symptoms **Measure:** Participants gastrointestinal symptoms report **Time Frame:** Baseline, at the end of the study period (20 weeks) and weekly until 20 weeks (for subjective GI symptoms report only) #### Secondary Outcomes **Measure:** Incretin-based AOM treatment discontinuation rate **Time Frame:** At the end of the study period (20 weeks) and weekly until 20 weeks **Description:** Weight (kg) by digital scale, height (cm) by altimeter. weight and height will be combined to report BMI in kg/(meter)\^2 **Measure:** Anthropometric measures - BMI **Time Frame:** Change from baseline at the end of the study period (20 weeks) **Description:** will be measured by tape measure (cm) **Measure:** Anthropometric measures - waist circumference (WC) **Time Frame:** Change from baseline at the end of the study period (20 weeks) **Description:** Body composition analysis using Inbody370S® includes measuring of fat mass (kg) , percentage of body fat (BF%), fat-free mass (kg), and skeletal muscle mass (kg). **Measure:** Body composition **Time Frame:** Change from baseline at the end of the study period (20 weeks) **Description:** 3-days food diaries and Israeli Ministry of Health Food Frequency Questionnaire (FFQ) that will be modified for the current study population **Measure:** Dietary intake **Time Frame:** Change from baseline at the end of the study period (20 weeks) **Description:** General questions regarding eating patterns, hydration and foods intolerance **Measure:** Eating habits assessment **Time Frame:** Change from baseline at the end of the study period (20 weeks) **Description:** Control of Eating Questionnaire (CoEQ) - The of CoEQ consists of 21 items (19 questions are rated by 100 mm VAS, and two question are open-ended). Greater score represents greater levels of Craving Control. **Measure:** Eating habits assessment - Control of Eating **Time Frame:** Change from baseline at the end of the study period (20 weeks) **Description:** Handgrip (HG) muscle Strength - measure static muscle strength (kg) of the upper extremities by a digital hand dynamometer (Jamar plus digital©) **Measure:** Functional parameters - muscle strength **Time Frame:** Change from baseline at the end of the study period (20 weeks) **Description:** 30-seconds sit and stand test - counts the number of times the patient stands in 30 seconds. Higher scores means a better outcome. **Measure:** Functional parameters- leg strength and endurance **Time Frame:** Change from baseline at the end of the study period (20 weeks) **Description:** EQ-5D-3L questionnaire -include the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS) .The EQ-5D-3L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.The EQ VAS records the patient's self-rated health. Participants will be asked to subjectively rate their overall state of health by using a 0 to 100 VAS, with a higher score reflects a better outcome. **Measure:** Quality of life assessment **Time Frame:** Change from baseline at the end of the study period (20 weeks) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * individuals aged ≥ 18 years * eligible to receive AOM \[i.e., BMI ≥ 30 kg/m2 or ≥ 27 kg/m2 with at least one adiposity-related coexisting condition (e.g., diabetes or pre-diabetes, hypertension, dyslipidemia, obstructive sleep apnea, fatty liver, cardiovascular disease)\] * who can read and speak Hebrew. Exclusion Criteria: * contraindications for treatment with Wegovy© \[i.e., personal or family history of medullary thyroid cancer (MTC), personal history of multiple endocrine neoplasia type 2 (MEN2) syndrome, a history of acute pancreatitis from an unknown etiology, attempting conception, current pregnancy or breastfeeding\] * previous bariatric surgery or endo-bariatric procedure * history of chronic pancreatitis * treatment with AOM within 6 months before enrollment * patients with type 1 diabetes mellitus * patients who underwent other major GI surgery prior to medication treatment * patient with underlying GI disease \[e.g., gastroparesis, celiac, Inflammatory Bowel Disease (IBD)\] * a positive diagnosis of small-intestinal bacterial overgrowth (SIBO) * patients with active gastritis, gastroenteritis * chronic usage of promotility drugs or laxatives * patients with uncontrolled mental illness * significant cognitive deterioration * alcohol consumption exceeding 1 drink per day for women and 2 drinks per day for men (32). In addition, Participants who will decide not to initiate or stop Wegovy© treatment for a period of more than two consecutive weeks for any reason or who undergo bariatric surgery or endoscopic sleeve gastroplasty during the study period will be excluded from the study. **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:** Shiri Sherf-dagan, Ph.D **Phone:** +972747288004 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Rotem Refaeli **Phone:** +972545797995 **Role:** CONTACT #### Locations **Location 1:** **City:** Ariel **Country:** Israel **Facility:** Ariel University **Zip:** 40700 ## 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: 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: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M27905 - Name: Incretins - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431295 **Brief Title:** Evaluation of a Digital Visual Acuity Device vs. Standard Visual Acuity Measurements **Official Title:** Human Performance Evaluation of a Digital Visual Acuity Device: Visual Acuity-001 #### Organization Study ID Info **ID:** 23-007148 #### Organization **Class:** OTHER **Full Name:** Mayo Clinic ### Status Module #### Completion Date **Date:** 2024-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **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:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mayo Clinic #### Responsible Party **Investigator Affiliation:** Mayo Clinic **Investigator Full Name:** Antonio J. Forte **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this research is to validate and determine the accuracy of the experimental device when measuring visual acuity versus our standard visual acuity measurements and to gather voice recordings of letters to help build a special system that recognizes spoken letters. ### Conditions Module **Conditions:** - Visual Acuity ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** SCREENING #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects for an ophthalmological examination that includes a visual acuity examination at Mayo Clinic in Florida have a digital visual acuity test conducted with the FaceScan device. **Intervention Names:** - Device: FaceScan **Label:** Digital Visual Acuity Test **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Digital Visual Acuity Test **Description:** Digital visual acuity device built for iOS ("iPhone") that conducts an assessment of visual acuity using a combination of integrated light detection and ranging (LiDAR) and voice processing. **Name:** FaceScan **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Number of subjects to have agreement between the visual acuity digital device and the clinical assessment **Measure:** Number of times the experimental device when measuring visual acuity agreed with standard visual acuity measurements **Time Frame:** Baseline #### Secondary Outcomes **Description:** Total number of voice samples collected of spoken letters **Measure:** Voice samples **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult patients (≥ 18 years) who come to Ophthalmology Clinic. * Willing and able to provide consent. Exclusion Criteria: * Individuals \< 18 years of age. * Unable to provide consent. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Jacksonville **Country:** United States **Facility:** Mayo Clinic in Florida **State:** Florida **Zip:** 32224 #### Overall Officials **Official 1:** **Affiliation:** Mayo Clinic **Name:** Antonio Forte, MD **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:** NCT06431282 **Brief Title:** Hyaluronic Acid Delivery: CO2 Laser Versus Thulium Laser Treatment **Official Title:** In Vivo Visualisation of Hyaluronic Acid After CO2 Laser Compared to Thulium Laser Treatment #### Organization Study ID Info **ID:** 01-24 #### Organization **Class:** OTHER **Full Name:** Universitätsklinikum Hamburg-Eppendorf ### Status Module #### Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-26 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-02-19 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universitätsklinikum Hamburg-Eppendorf #### Responsible Party **Investigator Affiliation:** Universitätsklinikum Hamburg-Eppendorf **Investigator Full Name:** Lynhda Nguyen **Investigator Title:** Principle Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** * Weakly crossed-linked hyaluronic acid (HA) can be delivered through multiple injections into the dermal and subnormal layer to improve skin quality. However, this treatment comes with multiple bumps for several days. * Alternatively, HA can be delivered after CO2 laser or thulium laser pretreatment. As microscopic analysis after this treatment is limited, the object of the present study is to investigate the morphological cellular changes after CO2 laser and thulium laser delivered HA into human skin. ### Conditions Module **Conditions:** - Aging Skin ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** OTHER #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Probands are treated with a CO2 laser. Afterwards a HA gel will be applied. **Intervention Names:** - Other: CO2 laser + HA **Label:** CO2 laser + HA **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Probands are treated with a thulium laser. Afterwards a HA gel will be applied. **Intervention Names:** - Other: Thulium laser + HA **Label:** Thulium laser + HA **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - CO2 laser + HA **Description:** Probands will be treated with a CO2 laser. Afterwards a HA gel will be applied. To measure microscopic cellular changes, a multiphoton tomography will be used. **Name:** CO2 laser + HA **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Thulium laser + HA **Description:** Probands will be treated with a thulium laser. Afterwards a HA gel will be applied. To measure microscopic cellular changes, a multiphoton tomography will be used. **Name:** Thulium laser + HA **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Size of intercellular spaces after CO2 or thulium laser treatment compared to control. **Measure:** Size of intercellular spaces **Time Frame:** 30 minutes and 30 days after treatment. **Description:** Size of keratinocytes after CO2 or thulium laser treatment compared to control. **Measure:** Size of keratinocytes **Time Frame:** 30 minutes and 30 days after treatment. **Description:** Size of HA granules after CO2 or thulium laser treatment compared to control. **Measure:** Size of hyaluronic acid granules **Time Frame:** 30 minutes and 30 days after treatment. **Description:** Distribution though the epidermal and dermal layers after CO2 or thulium laser treatment compared to control. **Measure:** Distribution of Hyaluronic Acid **Time Frame:** 30 minutes and 30 days after treatment. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: - healthy male and female patients Exclusion Criteria: * pregnancy, breast feeding * open wounds at the area to be treated **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Hamburg **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Lynhda Nguyen, Dr. med. - **Phone:** +49 (0)40 7410-0 - **Role:** CONTACT **Country:** Germany **Facility:** University Medical-Center Hamburg-Eppendorf **Status:** RECRUITING **Zip:** 20251 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Nguyen L, Mess C, Schneider SW, Huck V, Herberger K. In vivo visualisation of tattoo particles using multiphoton tomography and fluorescence lifetime imaging. Exp Dermatol. 2022 Nov;31(11):1712-1719. doi: 10.1111/exd.14646. Epub 2022 Jul 25. **PMID:** 35837813 ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M9878 - Name: Hyaluronic Acid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431269 **Acronym:** NEURODEV-IPA **Brief Title:** Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease **Official Title:** Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease #### Organization Study ID Info **ID:** 21_0291 #### Organization **Class:** OTHER **Full Name:** University Hospital, Montpellier #### Secondary ID Infos **Domain:** 2024-A00552-45 **ID:** ID-RCB **Type:** REGISTRY ### Status Module #### Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-25 **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:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Montpellier #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Feasibility and efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children aged 1 to 5 with Congenital Heart Disease **Detailed Description:** Congenital heart disease (CHD) is the leading cause of birth defects. Over 90% of children born with CHD reach adulthood. 50% of them will develop a neurodevelopmental disorder (NDD) that could affect life and long-term prognosis, including scholar and social integration and health related quality of life. In France, there is a lack of medical resources to screen NDD in this population and to refer patients for appropriate and early treatment. Investigators plan to propose a systematic early screening of NDD by an Advanced Practice Nurse (APN) during the usual cardiac follow-up. Children with CHD aged 1 to 5 will be included. If NDD is suspected, the patient will be referred to a neuropsychologist for NDD diagnosis confirmation and management planning. Patients with higher NDD risks (neonatal cardiac surgery) will benefit from a systematic neuropsychologist evaluation. This study will investigate the feasibility and performance of an APN screening in this NDD-high risk population. ### Conditions Module **Conditions:** - Congenital Heart Disease in Children - Neurodevelopmental Disorders **Keywords:** - congenital heart disease - neurodevelopmental screening - advanced practice nurse - organization of care - neuropsychological assessment ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 270 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Screening for neurodevelopmental disorders by an advanced practice nurse **Label:** Screening for neurodevelopmental disorders by an advanced practice nurse **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Screening for neurodevelopmental disorders by an advanced practice nurse **Description:** Screening for neurodevelopmental disorders by an advanced practice nurse with Ages \& Stages Questionnaires (ASQ-3) and Haute Autorité de Santé (HAS) identification scale **Name:** Screening for neurodevelopmental disorders by an advanced practice nurse **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** This will be evaluated by comparing the results of the IPA screening (using both HAS scale and ASQ-3 parent's questionnaire) with results of the advanced neuropsychologist assessment. A positive IPA screening is defined by a NDD alert using the HAS scale and/or the ASQ-3 parent's questionnaire. The advanced neuropsychologist assessment will be done only for patients with CHD with a positive IPA screening. **Measure:** Sensibility of the IPA screening for neurodevelopmental disorder (NDD) on the whole population studied **Time Frame:** 4 months (to obtain the neurophysiologist assessment) #### Secondary Outcomes **Description:** This rate will be calculated by dividing the complete IPA screenings (including HAS and the ASQ-3 parent's questionnaire) and children coming to the Complex Congenital Heart Defects consultation during the study period. **Measure:** Feasibility of the IPA screening for NDD **Time Frame:** 18 months **Description:** This will be evaluated by comparing the results of the IPA screening (using both HAS scale and ASQ-3 parent's questionnaire) with results of the advanced neuropsychologist assessment. A positive IPA screening is defined by a NDD alert using the HAS scale and/or the ASQ-3 parent's questionnaire. The advanced neuropsychologist assessment will be done only for patients with CHD with a positive IPA screening. **Measure:** Performance (sensibility) of the IPA screening for NDD on the NDD high risk population **Time Frame:** 4 months (to obtain the neurophysiologist assessment) **Description:** This will be evaluated by comparing the results of the IPA screening (using both HAS scale and ASQ-3 parent's questionnaire) with results of the advanced neuropsychologist assessment. A positive IPA screening is defined by a NDD alert using the HAS scale and/or the ASQ-3 parent's questionnaire. The advanced neuropsychologist assessment will be done only for patients with CHD with a positive IPA screening. **Measure:** Performance (specificity) of the IPA screening for NDD on the NDD high risk population **Time Frame:** 4 months (to obtain the neurophysiologist assessment) **Description:** This will be evaluated by comparing the results of the IPA screening (using both HAS scale and ASQ-3 parent's questionnaire) with results of the advanced neuropsychologist assessment. A positive IPA screening is defined by a NDD alert using the HAS scale and/or the ASQ-3 parent's questionnaire. The advanced neuropsychologist assessment will be done only for patients with CHD with a positive IPA screening. **Measure:** Performance (positive predictive value) of the IPA screening for NDD on the NDD high risk population **Time Frame:** 4 months (to obtain the neurophysiologist assessment) **Description:** This will be evaluated by comparing the results of the IPA screening (using both HAS scale and ASQ-3 parent's questionnaire) with results of the advanced neuropsychologist assessment. A positive IPA screening is defined by a NDD alert using the HAS scale and/or the ASQ-3 parent's questionnaire. The advanced neuropsychologist assessment will be done only for patients with CHD with a positive IPA screening. **Measure:** Performance (negative predictive value) of the IPA screening for NDD on the NDD high risk population **Time Frame:** 4 months (to obtain the neurophysiologist assessment) **Measure:** Prevalence of NDD in the high risk population **Time Frame:** 18 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Congenital heart disease with stable status defined by last operation \>3 months, no cardiac decompensation in the last 3 months, no planned surgery within 6 months after the inclusion * Cardiac surgery and/or catheter-based cardiac intervention(s) during the first year of life, * Patient aged 1 to 5 years. * No previous medical diagnosis of NDD * Parental or legal guardian's consent. * Social security affiliation (for France only) Exclusion Criteria: * Genetic or poly-malformative syndrome with usual neurodevelopmental care (CAMPS-type care network) * Neurodevelopmental status evaluation within the last 6 months. **Maximum Age:** 5 Years **Minimum Age:** 1 Year **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Marie VINCENTI, MD **Phone:** 04 67 33 66 39 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Clinical Research Associate **Phone:** 06 67 33 66 32 **Role:** CONTACT #### Locations **Location 1:** **City:** Montpellier **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Marie VINCENTI, MD - **Phone:** 04 67 33 66 39 - **Role:** CONTACT **Country:** France **Facility:** University Hospitial of Montpellier **Zip:** 34295 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000018376 - Term: Cardiovascular Abnormalities - ID: D000000013 - Term: Congenital Abnormalities - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M9419 - Name: Heart Diseases - Relevance: HIGH - As Found: Heart Disease - ID: M9418 - Name: Heart Defects, Congenital - Relevance: HIGH - As Found: Congenital Heart Disease - ID: M30644 - Name: Neurodevelopmental Disorders - Relevance: HIGH - As Found: Neurodevelopmental Disorders - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M20503 - Name: Cardiovascular Abnormalities - 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: D000006331 - Term: Heart Diseases - ID: D000006330 - Term: Heart Defects, Congenital - ID: D000065886 - Term: Neurodevelopmental Disorders ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431256 **Brief Title:** Ph3 Multicenter, 3wk RDBPC Efficacy, Safety & PK Study of Evening Dosed MPH HCl ER Capsules (HLD200) in Children 4-5 Yr With ADHD **Official Title:** Phase 3, Multicenter, 3-Week Fixed-dose, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy, Safety and Pharmacokinetic Study of Evening Dosed Methylphenidate Hydrochloride Extended-Release Capsules (HLD200) in Children Aged 4 to 5 Years With ADHD #### Organization Study ID Info **ID:** HLD200-112 #### Organization **Class:** OTHER **Full Name:** Ironshore Pharmaceuticals and Development, Inc ### Status Module #### Completion Date **Date:** 2026-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-08 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ironshore Pharmaceuticals and Development, Inc #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** This study will evaluate the efficacy, safety and pharmacokinetics of HLD200 (20 mg and 40 mg) in children aged 4 to 5 years with ADHD. **Detailed Description:** This is a multicenter, 3 week fixed dose, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety and pharmacokinetics of HLD200 (20 mg and 40 mg) in children aged 4 to 5 years with ADHD. Participants will be screened for eligibility for up to 4 weeks. Eligible participants will be treated with study medication for 3 weeks followed by a 2 week safety follow-up following the end of study treatment. The total duration of the study is up to 9 weeks. A single pharmacokinetic (PK) sample will be taken from each participant, in a prespecified PK sampling window at visit 5, for population PK analysis. A total of 168 participants (56 per treatment arm) will be randomized at Visit 2. ### Conditions Module **Conditions:** - Attention Deficit Hyperactivity Disorder ### 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:** 168 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Matching placebo to HLD200 20 mg capsule (×2) for 3 weeks (prescribed at Visits 2, 3, and 4) **Intervention Names:** - Drug: Placebo HLD200 capsules **Label:** Placebo Comparator **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** HLD200 20 mg placebo capsule (×1) and HLD200 20 mg active capsule (×1) for 3 weeks (prescribed at Visits 2, 3, and 4) **Intervention Names:** - Drug: HLD200 methylphenidate hydrochloride capsules **Label:** HLD200 20 mg **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** HLD200 20 mg placebo capsule (×1) and HLD200 20 mg active capsule (×1) for the first week (prescribed at Visit 2), with up-titration for the final 2 weeks to HLD200 20 mg active capsules (×2) (prescribed at Visits 3 and 4) **Intervention Names:** - Drug: HLD200 methylphenidate hydrochloride capsules **Label:** HLD200 40 mg **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - HLD200 20 mg - HLD200 40 mg **Description:** Doses: 20mg capsules **Name:** HLD200 methylphenidate hydrochloride capsules **Other Names:** - methylphenidate **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo Comparator **Description:** Doses: 20mg capsules **Name:** Placebo HLD200 capsules **Other Names:** - placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The change in ADHD Rating Scale-IV (ADHD RS IV) Preschool Version Total Score from Baseline (Visit 2) to Visit 5 for participants receiving HLD200 compared to participants receiving placebo in ITT population **Measure:** Primary Efficacy Endpoint **Time Frame:** 3 weeks #### Secondary Outcomes **Description:** The change in Clinical Global Impression - Severity (CGI-S) score from Baseline (Visit 2) to Visit 5 for participants receiving HLD200 compared to participants receiving placebo in ITT population **Measure:** Secondary Efficacy Endpoint **Time Frame:** 3 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Subject and the subject's parent(s)/legal guardian(s) must be available for the duration of the study. The subject's parent(s)/legal guardian(s) must be able to read, write, and/or understand at a level sufficient to provide signed and dated informed consent. In accordance with ICH GCP Guideline E6 and other applicable regulations, the Investigator, or a person designated by the Investigator, will obtain written informed consent from each subject's parent(s)/legal guardian(s) (and the subject's assent, if applicable) before any study-specific activity is performed. The Investigator will retain the original copy of each signed consent/assent document. 2. Subjects must be male or female children 4 to 5 years of age at the time of consent and assent (if applicable). 3. Subjects must have a diagnosis of ADHD as defined by the DSM-5 criteria with confirmation using the Mini - International Neuropsychiatric Interview for Children and Adolescents (MINI KID). 4. Subjects must meet the criteria for the therapeutic need for control of mild to moderate symptoms of ADHD at Screening (Visit 1) and/or Baseline (Visit 2) as determined by a medical evaluation and by an ADHD-RS-IV Preschool Version Parent score ≥ 93rd percentile cut-off normalized for sex in ≥ 1 of the following: Hyperactivity/Impulsivity subscale score (≥17 for boys; ≥14 for girls), Inattention subscale score (≥14 for boys; ≥12 for girls), or Total Score (≥32 for boys; ≥24 for girls); and a Clinical Global Impression - Severity (CGI-S) score ≥4. 5. Subjects must have a Peabody Picture Vocabulary Test 4 (PPVT-4) Standard Score ≥70 at Screening. 6. Subject has undergone an adequate course of nonpharmacologic treatment or has a severe enough condition in the opinion of the Investigator to consider enrollment without undergoing prior nonpharmacological treatment. 7. Subject's height and weight at Screening are between the 5th and 95th percentiles according to the Centers for Disease Control and Prevention growth charts by age and sex. 8. Subject must have a resting pulse less than 127 bpm, systolic and diastolic blood pressure below the 95th percentile for age and gender according to the 2017 American Academy of Pediatrics guidelines7 based on the average of 3 measurements 2 to 5 minutes apart at Visit 1 and Visit 2, (only a single measurement is required at Visit 2 unless an elevated excursion is noted which requires the averaged value of triplicate measurements). 9. Subject must be considered clinically appropriate for treatment with HLD200. 10. Subject must be in general good health based upon medical history, physical examination, clinical laboratory examinations, vital signs, and 12-lead electrocardiogram (ECG) assessment Exclusion Criteria: 1. History of, or current, medical condition, including gastrointestinal disorders (e.g., surgery, malabsorption syndrome, and other similar conditions), open-angle glaucoma, abnormally increased intraocular pressure (IOP), or laboratory result that, in the opinion of the Investigator, unfavorably alters the risk-benefit of study participation, may jeopardize subject safety, or may interfere with the satisfactory completion of the study and study related procedures. 2. Serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, severe hypertension, untreated thyroid disease, peripheral vasculopathy, known structural cardiac disorders, serious cardiac conditions, serious arrhythmias, known family history of sudden death, or other cardiac problems that may place the subject at increased vulnerability to the sympathomimetic effects of a stimulant drug. 3. History of seizure disorder (except febrile seizures prior to age 4 and with last occurrence at least 1 year prior to study participation), Tourette's disorder, or intellectual disability of minor severity or greater (DSM-5 criteria). 4. Subject has any diagnosis of psychosis, bipolar I or II disorder, major depressive disorder, anxiety disorder, eating disorder, conduct disorder, obsessive-compulsive disorder, any history of psychosis, autism spectrum disorder, tic disorders, disruptive mood dysregulation disorder, intellectual disability, Tourette's Syndrome, confirmed genetic disorder with cognitive and/or behavioral disturbances. Subjects with oppositional defiant disorder (ODD) are permitted to enroll in the study as long as ODD is not the primary focus of treatment, and, in the opinion of the Investigator, the ODD is mild to moderate, and eligible subjects with ODD are appropriate and cooperative during screening. Additionally, subject has any other conditions that, in the Investigator's opinion, may jeopardize subject safety or may interfere with the satisfactory completion of the study and study-related procedures. 5. Subject is currently considered at risk of suicide in the opinion of the Investigator, has previously made a suicide attempt, or has a history of, or is currently demonstrating active suicidal ideation or behavior. 6. History of severe allergic reaction or intolerance to MPH. 7. Alanine aminotransferase, aspartate aminotransferase, total bilirubin, or creatinine greater than 1.5 times the upper limit of normal. Elevated bilirubin due to Gilbert's syndrome is not exclusionary. 8. Use of prescription medications (except allowed medications) within 7 days of Baseline (Visit 2), except for ADHD stimulant medication (within 72 hours \[3 days\] of Baseline Visit 2), clonidine and guanfacine (5 days of Baseline Visit 2), atomoxetine (7 days of Baseline Visit 2), monoamine oxidase (MAO) inhibitors (14 days of Baseline Visit 2), and nonprescription/over-the-counter medications (except allowed medications) within the 3 days preceding Baseline (Visit 2). Medications not covered in allowed medications or prohibited medications must be cleared by the Medical Monitor prior to enrolling the subject. 9. Use of psychotropic medications including antidepressants, mood stabilizers, and antipsychotics within 14 days of Baseline. 10. Participation in a clinical trial with an investigational drug within the 30 days preceding study enrollment. 11. Initiation of non-pharmacological treatment within 30 days prior to Baseline (Visit 2). Subject may not initiate any new non-pharmacological treatment during the study. 12. Use of any other medications that might confound the results of the study or increase risk to the subject. 13. Subject is well-controlled on his/her current ADHD medication with acceptable tolerability. 14. In the opinion of the Investigator, the subject may have potential problems complying with the protocol or the procedures of the protocol, or for which the study could pose unnecessary safety risks. 15. Subject has a sibling or step-sibling that is concurrently participating in this study or who has previously participated in this study 16. Subject or caregiver is a participating Investigator, Sub-investigator, study coordinator, or employee of a participating Investigator, or is an immediate family member of the aforementioned. 17. Any factor, which in the opinion of the Investigator would jeopardize the evaluation or safety or be associated with poor adherence to the protocol **Maximum Age:** 5 Years **Minimum Age:** 4 Years **Sex:** ALL **Standard Ages:** - CHILD ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019958 - Term: Attention Deficit and Disruptive Behavior Disorders - ID: D000065886 - Term: Neurodevelopmental Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M9999 - Name: Hyperkinesis - Relevance: LOW - As Found: Unknown - ID: M4594 - Name: Attention Deficit Disorder with Hyperactivity - Relevance: HIGH - As Found: Attention Deficit Hyperactivity Disorder - ID: M21830 - Name: Attention Deficit and Disruptive Behavior Disorders - Relevance: LOW - As Found: Unknown - ID: M30644 - Name: Neurodevelopmental Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001289 - Term: Attention Deficit Disorder with Hyperactivity ### Intervention Browse Module - Ancestors - ID: D000000697 - Term: Central Nervous System Stimulants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018765 - Term: Dopamine Uptake Inhibitors - ID: D000014179 - Term: Neurotransmitter Uptake Inhibitors - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000015259 - Term: Dopamine Agents - ID: D000018377 - Term: Neurotransmitter Agents ### Intervention Browse Module - Browse Branches - Abbrev: CNSSti - Name: Central Nervous System Stimulants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CaAg - Name: Cardiotonic Agents ### Intervention Browse Module - Browse Leaves - ID: M11748 - Name: Methylphenidate - Relevance: HIGH - As Found: Every 2 weeks - ID: M4029 - Name: Central Nervous System Stimulants - Relevance: LOW - As Found: Unknown - ID: M7473 - Name: Dopamine - Relevance: LOW - As Found: Unknown - ID: M20832 - Name: Dopamine Uptake Inhibitors - Relevance: LOW - As Found: Unknown - ID: M17962 - Name: Dopamine Agents - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000008774 - Term: Methylphenidate ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431243 **Brief Title:** A Clinical Study of Puesta Mesylate for Injection in Patients With Solid Tumors **Official Title:** An Open, Multicenter Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the Combination of Puesta Mesylate for Injection in the Treatment of Advanced Solid Tumors #### Organization Study ID Info **ID:** ZLPM-003-1.0 #### Organization **Class:** INDUSTRY **Full Name:** Chengdu Zenitar Biomedical Technology Co., Ltd ### Status Module #### Completion Date **Date:** 2026-11-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-31 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Chengdu Zenitar Biomedical Technology 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:** Primary Purpose Phase Ib Evaluate the safety and tolerability of the combination of puesta mesylate in the treatment of advanced solid tumors; and explore the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of the combination of puesta mesylate in patients with advanced solid tumors; Determine the recommended phase II dose (RP2D) for the combination of puesta mesylate in the treatment of advanced solid tumors. Phase IIa. To further evaluate the preliminary efficacy of the combination of puesta mesylate in patients with advanced solid tumors. Secondary objective Phase Ib Evaluate the safety and tolerability of poystat mesylate monotherapy in advanced solid tumors; To evaluate the preliminary efficacy of the combination of poystat mesylate in patients with advanced solid tumors; To evaluate the pharmacokinetic profile of the combination of puesta mesylate in the treatment of advanced solid tumors. Phase IIa To further evaluate the safety and tolerability of the combination of puesta mesylate in the treatment of advanced solid tumors; To evaluate the pharmacokinetic profile of the combination of puesta mesylate in the treatment of advanced solid tumors. Exploratory Objective. To evaluate the pharmacodynamic significance of biomarkers in the combination of puesta mesylate for the treatment of advanced solid tumors. ### Conditions Module **Conditions:** - Advanced Solid Tumor ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In Cohort A, subjects in the ascending-dose group received PM IV, administered at a frequency of BiW (2 times per week) for 2 weeks, i.e., on days 1, 4, 8, and 11 of each cycle, with a 1-week discontinuation to allow for a 21-day cycle (with a minimum interval of ≥48 h between each of the 2 doses within the same dosing cycle), and exemestane was administered orally once a day within 30 min after the end of breakfast as one tablet ( 25 mg). Based on the results obtained in the dose-escalation phase, the necessity of the phase IIa expansion cohort and the dose of PM to be administered will be decided after discussion by the SMC, and the phase IIa cohort expansion is expected to select 1-2 dose groups of 10-15 cases each, with a total of 19-54 cases in this cohort **Intervention Names:** - Drug: A group Purinostat Mesylate 6mg/m2 - Drug: A group Purinostat Mesylate 8.4mg/m2 - Drug: A group Purinostat Mesylate 11.2mg/m2 - Drug: A group Purinostat Mesylate 15.0mg/m2 **Label:** A group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** In Cohort B, subjects in the ascending dose group all received PM IV drip administered at a frequency of BiW (2 times per week) for 2 consecutive weeks, i.e., on days 1, 4, 8, and 11 of each cycle, with a 1-week discontinuation for a 21-day cycle (with a minimum interval of ≥48 h between each of the 2 doses in the same dosing cycle). Tirelizumab was administered as 200 mg IV every 3 weeks, administered on the first day of each cycle. Based on the results obtained during the dose-escalation phase, the need for and the dose of the Phase IIa expansion cohort will be determined after discussion by the Safety Management Committee (SMC), and the Phase IIa cohort expansion is expected to select 1-2 dosage groups of 10-15 cases each. **Intervention Names:** - Drug: B group Purinostat Mesylate 6.0mg/m2 - Drug: B group Purinostat Mesylate 8.4 mg/m2 - Drug: B group Purinostat Mesylate 11.2 mg/m2 - Drug: B group Purinostat Mesylate 15.0 mg/m2 **Label:** B group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - A group **Description:** Purinostat Mesylate 6mg/m2 + EM 25mg **Name:** A group Purinostat Mesylate 6mg/m2 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - A group **Description:** Purinostat Mesylate 8.4mg/m2 + EM 25mg **Name:** A group Purinostat Mesylate 8.4mg/m2 **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - A group **Description:** Purinostat Mesylate 11.2mg/m2 + EM 25mg **Name:** A group Purinostat Mesylate 11.2mg/m2 **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - A group **Description:** Purinostat Mesylate 15.0mg/m2 + EM 25mg **Name:** A group Purinostat Mesylate 15.0mg/m2 **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - B group **Description:** Purinostat Mesylate 6.0mg/m2 + Tislelizumab 200mg **Name:** B group Purinostat Mesylate 6.0mg/m2 **Type:** DRUG #### Intervention 6 **Arm Group Labels:** - B group **Description:** Purinostat Mesylate 8.4mg/m2 + Tislelizumab 200mg **Name:** B group Purinostat Mesylate 8.4 mg/m2 **Type:** DRUG #### Intervention 7 **Arm Group Labels:** - B group **Description:** Purinostat Mesylate 11.2mg/m2 + Tislelizumab 200mg **Name:** B group Purinostat Mesylate 11.2 mg/m2 **Type:** DRUG #### Intervention 8 **Arm Group Labels:** - B group **Description:** Purinostat Mesylate 15.0mg/m2 + Tislelizumab 200mg **Name:** B group Purinostat Mesylate 15.0 mg/m2 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** defined as the proportion of subjects with an overall efficacy response of complete remission (CR) or partial remission (PR) after at least one baseline evaluation during the trial. **Measure:** Objective remission rate (ORR) **Time Frame:** Second cycle Day 30 / Fourth cycle Day 60 / Sixth cycle Day 90 (each cycle is 21 days) #### Secondary Outcomes **Description:** defined as the proportion of subjects with an overall efficacy response of CR after at least one baseline evaluation during the trial; **Measure:** Complete Remission Rate (CRR) **Time Frame:** Second cycle Day 30 / Fourth cycle Day 60 / Sixth cycle Day 90 (each cycle is 21 days) **Description:** defined as the proportion of subjects with an overall efficacy response of CR, PR and stable disease (SD) after at least one baseline evaluation during the trial; **Measure:** Disease Control Rate (DCR) **Time Frame:** Second cycle Day 30 / Fourth cycle Day 60 / Sixth cycle Day 90 (each cycle is 21 days) **Description:** defined as the duration from first remission (PR and above) to disease progression or death; **Measure:** Duration of remission (DOR) **Time Frame:** Second cycle Day 30 / Fourth cycle Day 60 / Sixth cycle Day 90 (each cycle is 21 days) **Description:** defined as the time from first dose to the appearance of PR and beyond; **Measure:** Time to Tumor Remission (TTR) **Time Frame:** Second cycle Day 30 / Fourth cycle Day 60 / Sixth cycle Day 90 (each cycle is 21 days) **Description:** defined as the time from first dose to disease progression or death **Measure:** Progression-free survival (PFS) **Time Frame:** Second cycle Day 30 / Fourth cycle Day 60 / Sixth cycle Day 90 (each cycle is 21 days) **Description:** defined as the time from first dose to death. **Measure:** Overall survival (OS) **Time Frame:** Second cycle Day 30 / Fourth cycle Day 60 / Sixth cycle Day 90 (each cycle is 21 days) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. age: ≥18 years and ≤75 years, regardless of gender; 2. at least one measurable lesion as defined by RECIST 1.1 in the Screening Phase (non-measurable lesions with simple bone metastases only are acceptable in the Dose Escalation Phase of the Breast Cancer Cohort); 3. single-agent dose-escalation phase in Phase Ib: Locally advanced or metastatic solid tumors, including but not limited to triple-negative breast cancer, colorectal cancer, and uroepithelial carcinoma, that have been diagnosed by histologic or cytologic confirmation of pathology and have failed standard therapy, or for which there is no standard treatment regimen available or for which standard therapy is not appropriate at this stage; Phase Ib Combination Dose Escalation Phase: 1. Combination exemestane for Cohort A (breast cancer): Perimenopausal, premenopausal, and postmenopausal women with breast cancer confirmed by histopathology or cytologic pathology to be estrogen receptor (ER)-positive, progesterone receptor (PgR)-negative or -positive, and non-HER2-positive (including HER2-negative and low-expressing populations); Progression or recurrence after at least 1 line of prior endocrine therapy (whether at advanced stage, in the setting of metastasis, or with neoadjuvant chemotherapy), and prior availability of no more than 1 line of chemotherapy (note: if prior endocrine therapy was adjuvant to exemestane, the disease-free interval after discontinuation of exemestane needs to be \>12 months); Not suitable for surgical resection therapy; Definition of menopause is subject to one of the following conditions: a) prior bilateral oophorectomy; b) 60 years of age and older; c) younger than 60 years of age, not on chemotherapy, tamoxifen, toremifene, or ovarian suppression therapy within one year prior to enrollment, who has been naturally menopausal for more than 12 months, and whose serum follicle-stimulating hormone and oestradiol are at postmenopausal levels; d) younger than 60 years of age, who is undergoing tamoxifen moxifene or toremifene therapy, and serum follicle-stimulating hormone and estradiol levels are in the postmenopausal range for two consecutive periods; e). Failure to meet the above criteria is considered to be in the premenopausal or perimenopausal period, and female subjects will be required to meet the following criteria: initiation of a luteinizing hormone-releasing hormone (LHRH) agonist, such as goserelin, leuprolide, etc., at least 28 ± 2 prior to the first administration of study drug (hormone level eligibility will be required for those who have been on an LHRH agonist for ≥ 21 days and \< 26 days prior to the first administration of the study drug), and the subject requires continued use of this class of medication for the duration of study treatment; 2. Combination tirilizumab for treatment of Cohort B (solid tumors): Patients with locally advanced or metastatic solid tumors who have a cytologically or histologically confirmed diagnosis and have failed standard therapy, or for whom there is no standard therapeutic regimen, or for whom standard therapy is not appropriate at this stage, as defined by standard therapy failure for each tumor type below: Non-small cell lung cancer: (1) patients with metastatic no driver mutation: disease progression or recurrence after at least second-line treatment (including platinum-containing chemotherapy); (2) patients whose tumors have driver mutations such as EGFR, ROS1, ALK, etc., should have received a failed targeted therapy against these mutations, and then after at least second-line treatment (including platinum-containing chemotherapy) disease progression or recurrence; Small cell lung cancer: disease progression or recurrence after at least two lines of prior therapy; Colorectal cancer: disease progression or recurrence after at least two lines of prior therapy (standard chemotherapy regimens received include fluorouracil or its derivatives, oxaliplatin, and irinotecan, BRAF inhibitors for patients with BRAF V600E mutation, and PD-1/PD-L1 therapy for those who meet the MSI-H/dMMR criteria). (treatment); Squamous cell carcinoma of the head and neck: disease progression or recurrence after at least two lines of prior therapy, including platinum-containing chemotherapy; Uroepithelial carcinoma: disease progression or recurrence after at least two lines of prior therapy (guideline-recommended regimens include PD-1/PD-L1 therapy, platinum-containing chemotherapy regimens, paclitaxel-based chemotherapy regimens, vediclizumab, and vincristine, and erdatinib has been used in patients with FGFR2/3 mutations); Esophageal cancer: disease progression or recurrence after at least two lines of prior therapy, including platinum-containing chemotherapy; cervical cancer: disease progression or recurrence after at least two lines of prior therapy (including platinum-containing chemotherapy; patients meeting the criteria for PD-L1 positivity or TMB-H or MSI-H/dMMR need to have been treated with PD-1/PD-L1) Hepatocellular carcinoma: Disease progression or recurrence after at least two lines of prior therapy; Renal cell carcinoma: disease progression or recurrence after at least two lines of prior therapy; Phase IIa Dose Expansion Phase: The tumor type and tumor tissue biomarker requirements for each expansion cohort enrolled in Phase IIa will be based on Phase Ib data and SMC discussion for further decision making; 4. ECOG ≤ 1 point; 5. expected survival ≥ 12 weeks; 6. organ function levels must meet the following requirements: 1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; 2. Hemoglobin (HGB) ≥ 90 g/L; 3. Platelet count (PLT) ≥100×109/L; 4. serum creatinine ≤1.5 × ULN or estimated creatinine clearance ≥60 mL/min (according to the Cockcroft and Gault formula); 5. serum total bilirubin (TBil) ≤ 1.5 x ULN, allowing TBil \> 1.5 x ULN but direct bilirubin (DBil) \< ULN for subjects with hepatic metastases or GILBERT syndrome; and AST and ALT ≤ 2.5 x ULN, allowing AST/ALT ≤ 5 x ULN for subjects with hepatic metastases or GILBERT syndrome; 7. those who agree to participate in this study and sign the informed consent form; 8. remission of all acute toxicities from prior anticancer therapy or surgery to baseline severity or NCI-CTCAE version 5.0 ≤ Grade 1 (with the exception of alopecia or other toxicities deemed by the investigator to pose no safety risk to the patient). Exclusion Criteria: 1. a known severe allergy to the study drug, combination drug, or any of its excipients (hydroxypropyl betacyclodextrin, arginine, glucosamine, mannitol); 2. current or prior other malignancy (except adequately treated basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the uterine cervix) unless treated radically and with evidence of recurrence-free metastasis within the last 5 years; 3. symptomatic central nervous system (CNS) metastases or asymptomatic CNS metastases requiring steroid therapy within 2 weeks prior to the first dose of study drug. Subjects with carcinomatous meningitis or molluscum contagiosum spread; 4. last systemic antineoplastic therapy (chemotherapy, targeted therapy, immunotherapy, biologic agent therapy, etc.) within 4 weeks prior to the first PM administration, with the following stipulations: nitrosoureas (e.g., carmustine, lomustine, etc.) or mitomycin C within 6 weeks prior to the first administration of the study drug; oral fluorouracil, small molecule targeted drugs within 2 weeks prior to the first administration of the study drug, or within 2 weeks prior to the first administration of a known drug within 5 half-lives (whichever is longer); local palliative radiotherapy within 2 weeks prior to the first administration of study drug; final administration of endocrine therapy within 4 weeks prior to the first administration of study drug; and receipt of herbal or proprietary Chinese medicine with an antitumor indication within 2 weeks prior to the first administration of study drug; 5. patients who have received a prior HDAC inhibitor; 6. patients with prior exemestane therapy are not eligible for enrollment in the combination exemestane treatment cohort, but are permitted to be included if the patient has a disease-free interval DFI of \>12 months after exemestane adjuvant therapy; 7. patients previously treated with anti-PD-1/PD-L1 antibodies are not eligible for enrollment in the combination tirilizumab treatment cohort, unless the patient has had a prior benefit after treatment in the advanced/metastatic phase\* then inclusion is permitted; * Benefit following anti-PD-1/PD-L1 antibody therapy is defined as meeting any of the following: 1. Best efficacy of CR or PR as assessed by imaging after receiving anti-PD-1/PD-L1 antibody therapy alone or in combination with targeted/other immunologic agents; 2. Treatment with anti-PD-1/PD-L1 antibody in combination with chemotherapy with no imaging evidence of disease progression within ≤ 6 months of treatment. 8. those who have had a serious infection within 4 weeks prior to the first administration of PM, or who have had an active infection requiring oral or intravenous antibiotic therapy within the previous 2 weeks; 9. receiving blood transfusions, recombinant human thrombopoietin, recombinant human interleukin-11, erythropoietin, and granulocyte colony-stimulating factor within 2 weeks prior to the first dose of study drug; 10. breast cancer: symptomatic, advanced patients who have disseminated to viscera and are at short-term risk of life-threatening complications (patients with visceral crises), patients with inflammatory breast cancer; 11. prior immune-related adverse events of grade ≥3 on immunotherapy are not eligible for enrollment in the combination tirilizumab treatment cohort; 12. patients with active or pre-existing autoimmune disease with potential for relapse (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.) are not eligible for enrollment in the cohort of co-tirilizumab; the following patients are allowed: patients with type I diabetes mellitus, and patients with autoimmune thyroiditis who may be eligible for alternative therapy; 13. Patients who have received systemically administered corticosteroids (prednisone \> 10 mg/day or equivalent) or other immunosuppressive agents within 14 days prior to the first dose of PM are not eligible for enrollment in the cohort of co-tirilizumab therapy; except for the following: treatment with topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids, and short-term prophylactic use of corticosteroids, eg. use of contrast media. 14. have uncontrolled or significant cardiovascular disease, including: (1) New York Heart Association (NYHA) Class II or greater congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first dose of PM, or the presence of an arrhythmia requiring treatment, left ventricular ejection fraction (LVEF) \<50% at screening; (2) Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, undetermined cardiomyopathy); (3) Screening-phase symptomatic coronary heart disease requiring pharmacologic treatment; (4) A history of clinically significant QTcF interval prolongation or a mean corrected QT interval (QTc) \>450 msec (men) or \>470 msec (women) on 3 electrocardiograms (ECGs) of the QTcF interval during the screening period (retesting is required and 3 average corrected values are taken only if the first ECG suggests that the QTc is \>450 msec (men) or \>470 msec (women)). (only the first ECG suggesting a QTc \>450 msec (men) or \>470 msec (women) needs to be retested and averaged over 3 corrections); a history of long QT syndrome or a confirmed family history of long QT syndrome; a history of clinically significant ventricular arrhythmia or current use of antiarrhythmic medications or implantation of defibrillation devices for the treatment of ventricular arrhythmias; (5) Cerebrovascular accident (including cerebral hemorrhage, cerebral infarction, transient ischemic attack, etc.) within 6 months prior to the first dose of PM; (6) Inadequate blood pressure control during the screening period (whether or not on antihypertensive medication): systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg; (7) Other cardiovascular diseases judged by the investigator to be inappropriate for enrollment. 15. Uncontrolled electrolyte disturbances that may interfere with the action of QTc prolonging medications (e.g., hypocalcemia \<1.0 mmol/L, hypokalemia \<lower limit of normal, hypomagnesemia \<0.5 mmol/L), but retesting after interventional therapy is permitted; 16. current or past history of interstitial lung disease of any severity and/or severely impaired lung function; 17. the presence of third interstitial fluid (e.g., pleural fluid and ascites) that cannot be controlled by drainage or other means; 18. major surgical procedures requiring general anesthesia or not withdrawn from other clinical trials within 4 weeks prior to the first dose of PM; surgical procedures requiring local/epidural anesthesia from which the patient has not recovered (except for tissue biopsy) within 2 weeks prior to enrollment; 19. clinically significant active infection of the following, including hepatitis B (HBV) and hepatitis C (HCV). Active hepatitis B was defined as subjects who were HBsAg-positive or HBcAb-positive with HBV-DNA above the lower limit of detection (i.e., the upper limit of normal values in the testing department of each study center), who achieved HBV-DNA negativity after antiviral treatment, who received antiviral medications for at least 2 weeks prior to the first dose of medication, and who were willing to continue to be treated with anti-hepatitis B virus for the duration of the study were allowed to enroll in the study, and active Hepatitis C was defined as HCV antibody positivity and HCV-RNA above the lower limit of detection (upper limit of normal). Positive syphilis spirochete antibody (TP-Ab) and positive syphilis non-specific antibody titer (RPR); 20. a history of immunodeficiency, including a positive test for antibodies to human immunodeficiency virus (HIV), or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; 21. participation in another interventional clinical trial within 4 weeks prior to enrollment; 22. female patients who are pregnant or breastfeeding or who are unable to ensure the use of contraception during the study period and for at least 6 months after the last treatment with poystat 23. other serious acute or chronic medical or psychiatric conditions or abnormal laboratory tests that may increase the risk of participation in the study or increase the risk associated with administration of the study drug or interfere with the results of the study, and other conditions that, in the opinion of the investigator, make the patient unsuitable for participation in this study. **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:** Liangkun Sun, bachelor **Phone:** 15885742617 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Zheng Jiang, bachelor **Phone:** 19048075294 **Role:** CONTACT #### Locations **Location 1:** **City:** Guanzhou **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Liushan Qu - **Phone:** 020-81332587 - **Role:** CONTACT **Country:** China **Facility:** Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University **State:** Guangzhou **Zip:** 510000 **Location 2:** **City:** Chengdu **Country:** China **Facility:** Chengdu Xinhua Hospital **State:** Sichuan **Zip:** 610000 #### Overall Officials **Official 1:** **Affiliation:** Sun Yat-sen Memorial Hospital,Sun Yat-sen University **Name:** Herui Yao, Doctor **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** West China Hospital **Name:** Yongsheng Wang, Doctor **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M137899 - Name: Tislelizumab - Relevance: LOW - As Found: Unknown - ID: M247237 - Name: Exemestane - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431230 **Acronym:** PEER-HEART **Brief Title:** School-based HIIT and Dose-Response Effects **Official Title:** Dose-response Relationship and High-intensity Interval Training Effects During Physical Education Lesson on Health Markers in Adolescents #### Organization Study ID Info **ID:** WUHSS #### Organization **Class:** OTHER **Full Name:** Wroclaw University of Health and Sport Sciences ### Status Module #### Completion Date **Date:** 2025-04-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Wroclaw University of Health and Sport Sciences #### Responsible Party **Investigator Affiliation:** Wroclaw University of Health and Sport Sciences **Investigator Full Name:** Jaroslaw Domaradzki **Investigator Title:** PhD, 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:** There are experimental evidences of the importance of high intensity exercises in health outcomes improvement. However, there are limited knowledge about possibility to affect health outcomes in adolescents through exercises programs introduced into physical education (PE) lesson. Moreover, there is lack of the studies identifying people who do not respond to stimuli, as well as examining potential determinants of non-responsiveness. Thirdly, there are no studies examining the modification of exercise dose that should be reflected in the response in such individuals. Aim of this human experiment is to examine the effects of one cycle of 8-weeks high-intensity interval training (HIIT) implemented in physical education lesson on: (1) body composition (proportions of the body fat to the body muscles), (2) resting blood pressure, (3) physical efficiency. Study are conducted for two years (two cycles). Each year 300 students of two secondary schools, are involved in project: 15-16-year-olds in first year, 18-19-year-olds in second year. Students are divided in experimental groups -performing 8-weeks (twice a week) cycle of HIIT implemented into PE lesson, and the control groups - students following a typical PE programme. Each cycle consists of two parts. First part is related to the 8 weeks of HIIT training, while second part is related to the dose-expose study. All participants are examined during project before (Pre), after (Post) and Follow-Up intervention. Second part is planned after a break of several months. Persons who do not respond to the exercise stimulus in the first part will follow individually modified programmes. They will be measured before and after this additional training. To examine the assumed HIIT-induced changes in participants the investigators will apply: (1) anthropometric measurements: body height and weight, and BMI will be calculated, (2) body mass composition (fat and muscle mass), (3) resting blood pressure, (4) beep test which is field motor specific test to assess physical efficiency. The results of this project will help to answer the fundamental questions about HIIT induced morphological and physiological effects in adolescents, what is important from scientific and public health point of view. Particularly, in view of the growing pandemic of obesity, common elevated blood pressure and steadily declining physical fitness in children and adolescents. **Detailed Description:** I. Background Prevalence of overweight and obesity is well documented in the literature. This applies to both adults and the elderly, but increasingly also to children and school-age youth. Similar to adipose tissue, there is a constant increase in the percentage of young individuals with elevated blood pressure. Moreover, children and adolescents are steadily decreasing their physical efficiency. All these characteristics serve as indicators of overall health, defined as health-related fitness (HRF). Measurements represent the health potential that adolescents bring into adulthood, what is closely related to their efficient functioning in family and professional life. In the battle against lifestyle diseases during adolescence, there is a growing trend towards implementing intense short-term efforts. Evidence from numerous studies confirms the effectiveness of High-Intensity Interval Training (HIIT) in reducing body weight, improving body mass index (BMI), reducing body fat, and lowering resting blood pressure. Due to the reluctance of children and adolescents to engage in physical activity during leisure time, there is an increasing systemic implementation of HIIT in physical education classes to ensure widespread physical exercise among students. A separate issue is the lack of response to exercise in some individuals (so-called non-responders). There are few studies that attempt to find the optimal exercise dose to elicit a response in as many participants as possible, ideally in all participants (dose-response relationship). However, the effectiveness of training based on the duration of exercise and rest intervals, the type of exercises (endurance, resistance, etc.), and exercise intensity is still unknown. II. Research Project Objectives Therefore, the aims of this research are twofold: 1. to investigate the effectiveness of different forms of short-term, intense interval exercise in reducing body fat and resting blood pressure, as well as improving aerobic and anaerobic physical endurance; 2. after identifying non-responders and applying dose-response procedures, to develop modifications to the standard HIIT program and verify the effectiveness of these modifications in inducing the aforementioned positive changes. Hypothesis 1. The high-intensity intervention training, practising systematically during regular physical activity lessons, will affect body composition reducing body fat (through increased fat oxidation processes from very intensive exercises) and improve the fat to muscle mass proportions. In the experimental group participants with elevated blood pressure, blood pressure improvements will be observed what is connected with several physiological cardiovascular reactions. Thirdly, intensive physical short-time interval training will improve cardiorespiratory fitness. Hypothesis 2. There are frequency of participants who will not gain in different outcomes from intervention programme. Hypothesis 3. Programs of the HIIT intervention, individually tailored for non-responsive persons, including different determinants, induce the expected changes in the above-mentioned outcomes. III. Research design and work plan This project is longitudinal, planned for two years of study. Both years, called cycles, are Cluster Randomised Trials (in other words - Group-Randomized Trials, where research participants are not allocated to intervention independently, but as a group. Each cycle of the study has two parts. First part (called Common-HIIT) has two arms: experimental and control, while second part (called Dose-Response) has four arms: two experimental and two control. Simple random sampling without replacement is used to classify classes as experimental and control. The sampling frame is the list of classes with identifiers specific for each school (e.g. 1a, 1b, 2a etc.). Randomization process is carried out by the investigators of this study using specific library in R language. The project enrolls two types of students groups: experimental (EG) - circa 4 classes in each school, and control (CG) - circa 4 classes in each school. In Common-HIIT part, EG perform physical training intervention, while CG take part only in typical PE lessons. In Dose-Response part, non-responders (identified as persons who will not gain the effects during first part) will be randomly (the same procedure like in first part) divided into experimental group (NRs-E) and control group (NRs-C), while responders (identified as persons who will gain the effects during first part) will also be randomly (the same procedure like in the firs part) divided into experimental (Rs-E) and control (Rs-C) group. In Common-HIIT part, all participants are examined during preintervention, postintervention and follow-up measurements. While, in Dose-Response part they are examined twice: preintervention and postintervention dose-response intervention. IV. Research methodology IV.1 Subject characteristics. The sample size was calculated based on pilot studies using G\*Power v. 3.1, resulting in a minimum sample size of 310 individuals (with a 5% dropout margin). The study involves students from first and fourth grades, who are involved in project in first and second cycle, respectively. Two high schools in the city of Wrocław were selected for the study. Participants are separated in sex groups, what is related to rules of the schools. IV.2. Intervention procedures. The design used a parallel group study scheme (2 schools) with three replicates. In each school a different form of intervention based generally on the principles of the HIIT programme will be implemented. In one school a classical variant is planned, while in the other a variant using a plyometric mechanism is planned. The project use an intensive intermittent exercise intervention. In one school, a standard programme is planned, in the other a modification involving a plyometric form of exercise. The chosen high-intensity interval programme is very useful in the school setting due to its simplicity of implementation and short time. It can be easily implemented into a lesson without strongly interfering with the flow of the lesson and the fulfilment of the teacher's curricular tasks. In the intervention, 8 series of 20-second exercises and a 10-second rest are performed. The total duration is 4 minutes.The key is to perform the exercise on an intensity of 90%-100% of maximum effort. The short duration and the possibility to use different forms of exercise makes it attractive in the opinion of the participants and has a positive effect on motivation to exercise. In the first part of the study, regardless of the forms of exercise implemented in both schools, a standard HIIT intervention programme will be used. The intervention part will be preceded by a standard 10-minute pre-session warm-up. Participants will then embark on the main programme and perform intense work lasting 20 seconds and a 10-second rest interval. In the first four weeks, they will perform between four and six series, with the aim of doing a full cycle of eight series in the following four weeks. After all the series in a given cycle have been completed, there will be a 5-minute rest period. The teacher will then move on to the planned lesson tasks derived from the core curriculum. Achieving the correct exercise intensity is a critical factor in HIIT-type interventions. However, given that the intervention will take place in a school setting, it was assumed that participants would maintain an effort of at least 80% HRmax, throughout the 8-week period. Heart rate will be measured with Polar Verity Sense wristbands. Teacher are real-time control and motivate the student's effort as the intensity decreases. In the second part of the research, intervention modifications will be introduced that change the stimulus doses of the programmes. The details of the design of these modifications will be derived from the results obtained from the first part of the research.The following will be modified the proportions of work and rest breaks, the structure and/or form of the exercises. Non-responsive individuals (who did not responded to the exercise in the first part by lowering their body fat and/or blood pressure and/or improving their physical performance) and those who fail to maintain an effect over a period of 8 weeks will be allocated to subgroups in which they will be trained according to an appropriate modification. to subgroups where training will be modified accordingly. Heart rate values forming a time series will be stored in the application and exported to a database at the end of the project. These results will be collated with the measurements and survey data and used for detailed analyses. IV. 3. Measurements. Measurements are planned in three areas: morphological, cardiovascular and physical performance. Measurements of basic morphological characteristics will be carried out. Body height will be measured using an anthropometer with an accuracy of 0.1 cm (GPM Anthropological Instruments). Body weight will be measured on an electronic scale (body composition device) with an accuracy of 0.1 kg. Body composition will be also measured. Body composition device uses bioelectrical impedance method. Fat mass, muscle mass and water will be measured. On the basis of the measured morphological characteristics and body composition, the following are calculated indicators: relative body mass (BMI), relative fat mass (FMI), relative muscle mass (SMI) and muscle to fat ratio (MMI), muscle to fat ratio (MFR). Haemodynamic features of the blood circulation will be determined by resting measurements of systolic and diastolic blood pressure and heart rate. An electronic upper arm blood pressure monitor will be used. For the measurement of aerobic and anaerobic physical capacity, population tests are foreseen (respectively, a multi-level shuttle run, the so-called beep test. The measurements will be supplemented by the collection of survey data. This data will be the accompanying variables in the detailed, in-depth analyses. The following surveys are planned: the economic and social situation of the pupils' families (FAS scale), physical activity (IPAQ long form questionnaire) and frequency of food intake (KomPAN questionnaire). In addition, after each lesson unit, students will complete questionnaires with the subjective feeling of fatigue scale (RPE) and the lesson attractiveness scale (PACES). V. Statistical analysis Distributions of the collected data will be assessed. Depending on the type of distribution, parametric and non-parametric methods will be applied. In multivariate exploratory procedures, data not meeting the condition of normality of distribution will be transformed and scaled. Comparisons between multiple groups with repeated measures (MANOVA/ANOVA of mixed effects), examination of correlations (regression analysis in mixed models), examination of similarities (cluster analyses) and co-occurrence (correspondence analyses) are assumed. For dose-response relationship analyses, it is planned to use simple linear regression, polynomial regression (2nd and 3rd degree polynomial) and various multiple comparison procedures (Multiple Comparison Procedures family). The calculation will be carried out in the R environment \[43\] and other statistical software. ### Conditions Module **Conditions:** - Adolescents - Physical Activity - Adipose Tissue - Blood Pressure - Cardiorespiratory Fitness **Keywords:** - high-intensity interval training - adolescence - body composition - resting blood pressure - responders and non-responders - dose-response ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 600 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** SH-EG - Standard HIIT Experimental Group, participants who will perform typical high-intensity interval training **Intervention Names:** - Behavioral: standard high-intensity interval training **Label:** Standard HIIT Experimental Group (SH-EG) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** SH-CG - Standard HIIT Control Group, participants that will not perform the HIIT cycles **Label:** Standard HIIT control group (SH-CG) **Type:** NO_INTERVENTION #### Arm Group 3 **Description:** PH-EG - Plyometric HIIT Experimental Group, participants who will perform plyometric high-intensity interval training **Intervention Names:** - Behavioral: plyometric high-intensity interval training **Label:** Plyometric HIIT Experimental Group (PH-EG) **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** PH-CG - Plyometric HIIT Control Group, participants that will not perform the HIIT cycles **Label:** Plyometric HIIT Control Group (PH-CG) **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Standard HIIT Experimental Group (SH-EG) **Description:** The project will use an intensive intermittent exercise intervention according to the high-intensity interval training programme. The programme will be implemented during physical education lessons. It involves 4 minutes of exercise in a structure of 20 seconds of intense effort and 10 seconds of rest, for a total of 8 cycles. It will be repeated twice a week (in two PE lessons) for 8 weeks. It is based on the standard physical exercises: squats, push-ups, sit-ups, toe-touches, mountain climber, jumping jacks, standing abs twist and squat to side. **Name:** standard high-intensity interval training **Other Names:** - St-HIIT **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Plyometric HIIT Experimental Group (PH-EG) **Description:** The project will use an intensive intermittent exercise intervention according to the high-intensity interval training programme. The programme will be implemented during physical education lessons. It involves 4 minutes of exercise in a structure of 20 seconds of intense effort and 10 seconds of rest, for a total of 8 cycles. It will be repeated twice a week (in two PE lessons) for 8 weeks. However, there is a difference, comparing to the St-HIIT, related to different exercises used in protocol. This kind of HIIT programme will be based on plyometric exercises: jumping jacks, skip A, skip C, jumps back into a push-up position and returns to the squat position, throwing the legs out of support and jumping out, jumping out of a squat. **Name:** plyometric high-intensity interval training **Other Names:** - Pl-HIIT **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** tthe body composition measurement with electronic bio-impedance tool (InBody); this measurement is to evaluate the potential of the intervention in body fat reduction **Measure:** body fat weight (BF) **Time Frame:** Pre-HIIT, up to 24 weeks **Description:** the body composition measurement with electronic bio-impedance tool (InBody); this measurement is to evaluate the potential of the intervention in muscle mass increase **Measure:** skeletal body muscle mass (SMM) **Time Frame:** Pre-HIIT, up to 24 weeks **Description:** resting blood pressure parameter, this measurement is to evaluate the potential effect of the intervention on blood pressure, particularly the the potential to reduce resting blood pressure in people with raised blood pressure (prehypertension) **Measure:** systolic blood pressure (SBP) **Time Frame:** Pre-HIIT, up to 24 weeks **Description:** resting blood pressure parameter, this measurement is to evaluate the potential effect of the intervention on blood pressure, particularly the the potential to reduce resting blood pressure in people with raised blood pressure (prehypertension) **Measure:** diastolic blood pressure (DBP) **Time Frame:** Pre-HIIT, up to 24 weeks **Description:** cardiorespiratory fitness (CRF), evaluate the potential effect of intervention on aerobic capacity; CRF is assessed with Multistage Fitness Test (MFT), and evaluates maximum rate of oxygen intake (VO2max). Participants perform continuous 20-metre shuttle runs, with the individual having to reach the opposite end of the 20-metre grid before the next sound signal. The time between signals decreases with each minute, forcing individuals to increase their running speed. Initial running velocity is of 8.5 km/hr and increases the speed by 0.5 km/hr each minute thereafter. The test is comprised of 23 levels. The result the participant achieved (the speed on the last level before the end) is transformed and the final outcome is maximum rate of oxygen intake. However, VO2max is calculated from formula: VO₂ max = -27.4 + 6.0 (speed); where speed is determined by the level achieved by the participant before he/she is withdrawn from the test. **Measure:** physical efficiency (CRF) **Time Frame:** Pre-HIIT, up to 24 weeks #### Secondary Outcomes **Description:** measurement from basis to vertex (top of head) **Measure:** body height (BH) **Time Frame:** Pre-HIIT,up to 24 weeks **Description:** measurement of the body mass with InBody electronic scale **Measure:** body weight (BW) **Time Frame:** Pre-HIIT, up to 24 weeks **Description:** the body composition measurement with bio-impedance electronic tool (InBody); this measurement is to evaluate the potential intervention risk of dehydration **Measure:** body water (BWat) **Time Frame:** Pre-HIIT, up to 24 weeks **Description:** measurement from seat surface to vertex (top of head) **Measure:** sitting height (SBH) **Time Frame:** Pre-HIIT, up to 24 weeks **Description:** Family Affluence Scale (FAS) questionnaire related to the family social-economic situation, information will be used as confounding/covariate variable Family Affluence Scale (FAS) is a tool for analysing social inequalities in health. It consists of six questions relating to: the student's own room by the student, number of cars in the family, number of computers in the family, trips abroad with the family for holidays or holidays, and the number of bathrooms in the house and the provision of a dishwasher with a dishwasher. The FAS scale takes a range from 0 to 13 points. According to international recommendations, families are divided into: poor (0-6 points); average (7-9 points) and affluent (10-13 points). **Measure:** social-economic situation **Time Frame:** Pre-HIIT **Description:** International Physical Activity Questionnaire (IPAQ) related to the physical activity, The IPAQ asks about domains: leisure time, domestic and gardening-yard, work-related and transport-related activity and sitting (inactivity). Intensity of the activity is defined as: walking, moderate-intensity and vigorous intensity. Result can be presented as continuous scores (metabolic equivalent in minutes per week) or categorical: 1. inactive - individuals who not meet criteria for Categories 2 or 3, 2. minimally active - any one of the following 3 criteria: * 3 or more days of vigorous activity, OR * 5 or more days of moderate-intensity activity OR * 5 or more days of any combination of walking, moderate-intensity or vigorous intensity (600 metabolic equivalent-min/week). 3. health - at least 1.5 hour of being active throughout the day **Measure:** physical activity **Time Frame:** Pre-HIIT **Description:** questionnaire (questionnaire of eating behaviors KomPAN) is a tool for measurement of frequency of eating specific groups of meal, it is useful for evaluation of the eating behaviors; information will be used as confounding/covariate variable It consists: 1. question on the number of meals per day, 2. follow-up questions, 3. questions on the frequency of food intake, which are components of: index of a healthy diet (positive HDI) and unhealthy diet index (negative HDI), 4. questions about the respondent's lifestyle and personal data (all). Answers are transform to the scores related to healthy and unhealthy dietary behaviors. Minimum points for both indexes is 0, maximum is 100. Scores can be transform to the categories: 1. small intensity of traits nutrition - 0-33 points 2. moderate intensity of traits nutrition - 34-66 points 3. high intensity of traits nutrition - 67-100 points **Measure:** dietary intake **Time Frame:** Pre-HIIT **Description:** Rating of Perceived Exertion scale (RPE) of subjectively perceived fatigue; information will be used as confounding/covariate variable It runs from 0 - 10, using numbers to rate how much effort an activity takes. It examines 4 factors: (a) how fast is breathing, (b) how fast heart is beating, (c) how tired muscles are, (d) how much is sweating. The RPE scale rates exertion from a scale of 6 (no exertion) to 20 (maximum effort). Scale: 6 - no exertion, 7-8 - extremely light, 9-10 - very light, 11-12 - light, 13-14 - somewhat hard, 15-16 - hard (heavy) 17-18 - very hard, 19 - extremely hard 20 - maximum exertion. **Measure:** fatigue perception **Time Frame:** within 10 minutes after each cycle of HIIT **Description:** Physical Activity Enjoyment Scale (PACES), the attractiveness perceived during exercise by participants; it will be used as confounding/covariate variable It contains 18 items used to assess enjoyment, particularly during the physical activity. Respondents are asked to rate feelings at the moment about the physical activity, using a 7-point bipolar rating scale. Eleven items are reverse scored. An overall enjoyment for physical activity score is determined by summing the items, with a range of 18-126 being possible. Higher scores indicate higher enjoyment. **Measure:** perceived attractiveness of lessons **Time Frame:** within 10 minutes after each cycle of HIIT ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * For all participants: 1. active student of school enrolled in project, 2. age 14-16 or 18-20, 3. active student of 1st class in the school (for participants 14-16 years of age) or 4th class in the school (for participants 18-20 years of age), 4. active participation in PE lessons (no medical or other exemption from lessons), 5. no medical contraindications 6. signed informed consent (parent/legal guardian) in case of under-age participant). Exclusion Criteria: * For all participants: 1. commitment to structured sports training 2. injury less than 3 months prior to the intervention **Healthy Volunteers:** True **Maximum Age:** 20 Years **Minimum Age:** 14 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Wrocław **Country:** Poland **Facility:** Wroclaw University of Health and Sport Sciences **State:** Dolny Śląsk **Zip:** 51-612 #### Overall Officials **Official 1:** **Affiliation:** Wroclaw University of Health and Sport Sciences **Name:** Jarosław Domaradzki, 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:** NCT06431217 **Acronym:** GBSCoP **Brief Title:** Group B Strep Correlates of Protection Study **Official Title:** Investigating for Immunological Correlates of Protection Against Invasive Group B Streptococcus Disease in Infants Less Than 90 Days of Age. #### Organization Study ID Info **ID:** GBS CoP #### Organization **Class:** OTHER **Full Name:** University of Witwatersrand, South Africa ### Status Module #### Completion Date **Date:** 2020-12-31 **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:** 2020-12-31 **Type:** ACTUAL #### Start Date **Date:** 2019-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2019-03-05 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of KwaZulu **Class:** OTHER **Name:** University of Stellenbosch **Class:** OTHER **Name:** University of Pretoria **Class:** OTHER **Name:** University of Cape Town #### Lead Sponsor **Class:** OTHER **Name:** University of Witwatersrand, South Africa #### Responsible Party **Investigator Affiliation:** University of Witwatersrand, South Africa **Investigator Full Name:** Farzanah Laher **Investigator Title:** Doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Streptococcus agalactiae or Group B Streptococcus (GBS) is a leading cause of neonatal sepsis in developed and developing countries. The study aims to bolster the evidence base of establishing a sero-correlate of protection against invasive GBS disease in infants. These sero-correlates of protection will be used to study the effectiveness of GBS vaccine against invasive disease. **Detailed Description:** Observational Case-Control Study * A cohort of 15,000 mother-infant dyads will be enrolled at Chris Hani Baragwanath Academic Hospital (n=10,000) and Rahima Moosa Mother and Child Hospital(n=5,000) over an 18-24-month period, anticipated to start in the first quarter of 2019. * Enrolment into the cohort study will occur at antenatal clinic, during the early stages either of labour or immediately post-delivery. * In parallel, enrolment of GBS cases will occur at the time of diagnosis of invasive GBS disease. These "retrospective cases" will be enrolled at multiple facilities across South Africa. * Infants will be followed up until 89 days of age to identify cases of suspected sepsis and hospitalizations. Determine the infant GBS serotype Ia and III specific capsular serum IgG antibody level associated with 80% reduced odds of invasive GBS disease between 0-89 days of age for the combined "cohort" and "retrospectively enrolled" cases. ### Conditions Module **Conditions:** - Maternal Health, Child Health, Infectious Diseases ### Design Module #### Bio Spec **Description:** Maternal blood, Vaginal Swab collection, cord blood collection, DBS collection **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 17842 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Determine the infant GBS serotype Ia and III specific capsular serum IgG antibody level associated with 80% reduced odds of invasive GBS disease between 0-89 days of age for the combined "cohort" and "retrospectively enrolled" cases. Anti-CPS IgG concentrations were determined with the use of a quantitative direct immunoassay (Luminex) that measured levels of antibodies binding to CPS serotypes Ia, Ib, and II through V. **Measure:** Primary Objective **Time Frame:** 1 - 1.5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Pregnant women attending for antenatal care at one of the participating antenatal-clinics and/or delivering at CHBAH or RMMCH. 2. Subjects aged ≥18 years. 3. Able to understand and comply with planned study procedures. 4. Provides written informed consent. Exclusion Criteria: 1. Refusal to consent to study participation. 2. Receipt of any blood products in the past 4 weeks or anticipated during labour. **Healthy Volunteers:** True **Maximum Age:** 40 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** 5.1.1. Cohort population Maternal-newborn dyads enrolled at CHBAH or RMMCH prior to or during delivery-admission, from whom maternal and cord blood are collected. 5.1.2. Control population Controls will be defined as newborns born to mothers enrolled into the cohort study, whose mother is colonized by a serotype homologous to that of a case to which they matched, but who do not develop invasive GBS disease within 90 days of life. Cases and controls will matched by serotype, gestational age (34-\<37 weeks and ≥37 weeks gestation) and maternal age (\<25 years, 25-\<35 years and ≥35 years). Maternal HIV infection status will be assessed as an effect modifier. ### Contacts Locations Module #### Locations **Location 1:** **City:** Johannesburg **Country:** South Africa **Facility:** Rmpru/Vpd **State:** Gauteng **Zip:** 1862 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infectious Disease - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infectious Disease - ID: M16080 - Name: Streptococcal Infections - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003141 - Term: Communicable Diseases - ID: D000007239 - Term: Infections ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431204 **Brief Title:** Obstetric Comorbidity Index in Postpartum Hemorrhage **Official Title:** Obstetric Comorbidity Index for Prediction of Perioperative Severe Maternal Morbidity in Patients Undergoing Cesarean Delivery With Postpartum Hemorrhage #### Organization Study ID Info **ID:** 351/2567(IRB2) #### Organization **Class:** OTHER **Full Name:** Mahidol University #### Secondary ID Infos **Domain:** Siriraj Institutional Review Board **ID:** Si 359/2024 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2025-04-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-04-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mahidol 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:** The objective of this study is to examine the predictive capability of the Obstetric comorbidity index in the identification of severe maternal morbidity associated with postpartum hemorrhage in patients undergoing cesarean delivery. **Detailed Description:** The prospectively predictive maternal morbidity is imperative to enhance maternal outcomes. There has been development of the obstetric comorbidity index (OBCMI) by Bateman et al. in 2013 and performed with superior performance characteristics relative to general comorbidity measures in an obstetric population. The score has been a growing recognition of the necessity for specialized risk assessment tools tailored specifically to obstetric populations that differ from other populations. For instance, both the Charlson/Romano comorbidity index or the Elixhauser comorbidity score and their adaptations are deficient in accounting for obstetric conditions, thereby limiting their ability to predict obstetric morbidity or mortality. The Obstetric Comorbidity Index has undergone thorough examination and validation across multiple nations. These findings collectively demonstrate the index's capacity for moderate to high predictive accuracy in anticipating maternal morbidities, accompanied by a commendable discriminative performance. However, within the context of Thailand, investigations concerning the Obstetric Comorbidity Index and its association with perioperative complications or morbidities in postpartum hemorrhage patients undergoing cesarean delivery remain unexplored. Therefore, this study aims to elucidate the correlation between the Obstetric Comorbidity Index and severe maternal morbidity, while also scrutinizing the prevalence of comorbidities during the perioperative period among patients undergoing cesarean delivery at the largest University hospital, in THAILAND. Predicting the rate of maternal morbidity would be advantageous for facilitating preparation and augmenting awareness of complications during the perioperative period. ### Conditions Module **Conditions:** - Cesarean Section Complications - Postpartum Hemorrhage - Morbidity;Perinatal **Keywords:** - cesarean section - postpartum hemorrhage - maternal morbidity - obstetrics comorbidity index ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 576 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with either one of severe maternal morbidity (severe hemorrhage, hypertension/neurologic, renal, sepsis, pulmonary, cardiac, intensive care unit, and anesthesia complications) **Intervention Names:** - Other: Obstetric comorbidity index **Label:** Patients with postpartum hemorrhage with severe maternal morbidity #### Arm Group 2 **Description:** Patients without the severe maternal morbidity conditions **Intervention Names:** - Other: Obstetric comorbidity index **Label:** Patients with postpartum hemorrhage without severe maternal morbidity ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients with postpartum hemorrhage with severe maternal morbidity - Patients with postpartum hemorrhage without severe maternal morbidity **Description:** Obstetric comorbidity index score **Name:** Obstetric comorbidity index **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The prediction of severe maternal morbidity using obstetric comorbidity index presented in C-statistic (AUC of ROC) **Measure:** The prediction of severe maternal morbidity using obstetric comorbidity index **Time Frame:** in 72 hours after cesarean delivery #### Secondary Outcomes **Description:** Perioperative red blood cells transfusion in units **Measure:** Rate of blood transfusion **Time Frame:** in 72 hours after cesarean delivery **Description:** Quantity of postpartum hemorrhage in ml. **Measure:** Quantity of postpartum hemorrhage **Time Frame:** in 24 hours after cesarean delivery **Description:** Main cause of postpartum hemorrhage **Measure:** Cause of postpartum hemorrhage **Time Frame:** in 24 hours after cesarean delivery **Description:** Rate of intensive care unit admission **Measure:** Rate of ICU admission **Time Frame:** in 24 hours after cesarean delivery **Description:** Post operative complications eg. congestive heart failure, TRALI, acute kidney injury **Measure:** Rate of Postoperative complications **Time Frame:** in 72 hours after cesarean delivery **Description:** Neonatal Apgar score from 0 - 10 **Measure:** Neonatal Apgar score **Time Frame:** at 1-minute and 5-minute after delivery **Description:** Maternal death rate **Measure:** Rate of maternal mortality **Time Frame:** in 72 hours after cesarean delivery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: The patients underwent cesarean delivery with the diagnosis of postpartum hemorrhage (ICD-10 coding O72.1) Exclusion Criteria: * Cesarean delivery at less than 24 weeks of gestation * A patient chart that does not contain primary outcome data eg. absence of anesthetic record * Blood loss less than 1,000 ml in the first 24 hours postpartum **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** The chart of patients who underwent cesarean delivery with the diagnosis of postpartum hemorrhage (bleeding \>, = 1,000 ml) and gestational age of more than 24 weeks. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Patchareya Nivatpumin, M.D. **Phone:** +66896662187 **Role:** CONTACT #### Locations **Location 1:** **City:** Bangkok Noi **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Patchareya Nivatpumin, M.D. - **Phone:** +66896662187 - **Role:** CONTACT **Country:** Thailand **Facility:** Faculty of Medicine Siriraj Hospital **State:** Bangkok **Zip:** 10700 #### Overall Officials **Official 1:** **Affiliation:** Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok THAILAND **Name:** Patchareya Nivatpumin, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** We may balance the potential benefits and risks for each request and then provide the data that could be shared, together with the permission from our hospital director. **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000007744 - Term: Obstetric Labor Complications - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000011644 - Term: Puerperal Disorders - ID: D000014592 - Term: Uterine Hemorrhage ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions ### Condition Browse Module - Browse Leaves - ID: M9556 - Name: Hemorrhage - Relevance: HIGH - As Found: Hemorrhage - ID: M9559 - Name: Postpartum Hemorrhage - Relevance: HIGH - As Found: Postpartum Hemorrhage - ID: M10764 - Name: Obstetric Labor Complications - 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: M14499 - Name: Puerperal Disorders - Relevance: LOW - As Found: Unknown - ID: M17340 - Name: Uterine Hemorrhage - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006473 - Term: Postpartum Hemorrhage - ID: D000006470 - Term: Hemorrhage ### 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:** NCT06431191 **Brief Title:** Does Medial Raw Anchor Necessary During Tendon Repair Combined With Microfracture **Official Title:** Does Medial Raw Anchor Necessary During Tendon Repair Combined With Microfracture in Small to Medium Size Rotator Cuff Tear #### Organization Study ID Info **ID:** luyi #### Organization **Class:** OTHER **Full Name:** Beijing Jishuitan Hospital ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2023-03-18 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Beijing Jishuitan Hospital #### Responsible Party **Investigator Affiliation:** Beijing Jishuitan Hospital **Investigator Full Name:** Yi Lu **Investigator Title:** Director of Sports Medicine Service of Beijing Jishuitan hospital **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study is a prospective randomized controlled study of rotator cuff repair with lateral raw or double raw combined with microfracture procedure. The patients with rotator cuff tear were randomly divided into groups before the operation. The patients were followed up before and, 3 months, 6 months, 12 months and 24 months after surgery. In different time periods, the quantitative and qualitative indicators including pain, functional score, muscle strength, MRI performance, etc. were compared between groups at the same time period to evaluate the difference in the effect of double raw or only lateral raw repair combined with microfracture on the treatment of rotator cuff. In order to figure out whether medial raw anchor necessary during tendon repair combined with microfracture in small to medium size rotator cuff tear. ### Conditions Module **Conditions:** - Full Rotator Cuff Tear - Microfracture Procedure - Double Raw Repair - Lateral Raw Repair ### 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:** lateral raw repair for full tear rotator cuff combined microfracture procedure **Intervention Names:** - Procedure: lateral raw **Label:** Study group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** double raw repair for full tear rotator cuff combined microfracture procedure **Intervention Names:** - Procedure: double raw **Label:** Control group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Study group **Description:** lateral raw repair for full tear rotator cuff combined microfracture procedure, without medial raw **Name:** lateral raw **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Control group **Description:** double raw repair for full tear rotator cuff combined microfracture procedure **Name:** double raw **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** the rotator cuff re-tear rate was measured by MRI, MRI was performed to identify the status of the tendon **Measure:** rotator cuff re-tear rate **Time Frame:** 6, 12, 24 months postoperatively #### Secondary Outcomes **Description:** A score used to evaluate the pain, higher scores mean a worse outcome. **Measure:** VAS (Visual Analogue Scale) **Time Frame:** 1,2,3,7 days postoperatively and 3,6,12,24 months postoperatively **Description:** A score used to evaluate the shoulder function, higher scores mean a better outcome. **Measure:** ASES(American Shoulder and Elbow Surgeons'Form) **Time Frame:** 3,6,12,24 months postoperatively **Description:** A score used to evaluate the shoulder function,higher scores mean a better outcome. **Measure:** Constant score **Time Frame:** 3,6,12,24 months postoperatively **Description:** A score used to evaluate the shoulder function **Measure:** UCLA (University LosAngeles scoring system) **Time Frame:** 3,6,12,24 months postoperatively **Description:** A score used to evaluate the shoulder function,higher scores mean a better **Measure:** SST (simple shoulder test) **Time Frame:** 3,6,12,24 months postoperatively **Description:** Use a dynamometer to measure in N **Measure:** front extension, external rotation and internal rotation strength of shoulder **Time Frame:** 6,12,24 months postoperatively **Description:** surgical time, describe with minute **Measure:** surgical time **Time Frame:** immediately after the surgery **Description:** payment during the hospital stay, Treatment fee is calculated in RMB **Measure:** Hospitalization expenses **Time Frame:** immediately after the patient discharge ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Arthroscopy confirmed small to medium full rotator cuff tear * Unilateral rotator cuff injury * Voluntarily accept randomized controlled grouping, cooperate with treatment and follow up patients * Young and middle-aged patients aged 20 to 60 Exclusion Criteria: * Previous shoulder surgery (incision or arthroscopy) * Combined with diseases of other parts of the same limb * Combined with Bankart injury, acromioclavicular joint disease, greater tuberosity fracture, glenoid fracture and so on * Bilateral onset * Unable or unwilling to receive clinical follow-up **Maximum Age:** 60 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Beijing **Country:** China **Facility:** Beijing Jishuitan hospital **State:** Beijing **Zip:** 100000 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012421 - Term: Rupture - ID: D000014947 - Term: Wounds and Injuries - ID: D000070599 - Term: Shoulder Injuries - ID: D000013708 - Term: Tendon Injuries - ID: D000050723 - Term: Fractures, Bone ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M15241 - Name: Rupture - Relevance: LOW - As Found: Unknown - ID: M22785 - Name: Lacerations - Relevance: LOW - As Found: Unknown - ID: M624 - Name: Rotator Cuff Injuries - Relevance: HIGH - As Found: Rotator Cuff Tears - ID: M26370 - Name: Fractures, Bone - Relevance: LOW - As Found: Unknown - ID: M18332 - Name: Fractures, Stress - Relevance: HIGH - As Found: Microfracture - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M602 - Name: Shoulder Injuries - Relevance: LOW - As Found: Unknown - ID: M16479 - Name: Tendon Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000070636 - Term: Rotator Cuff Injuries - ID: D000015775 - Term: Fractures, Stress ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431178 **Brief Title:** General Anesthesia Versus Sedation By Dexmedetomidine and Ketamine With Local Infiltration for Percutaneous Transcatheter Closure of Atrial Septal Defect in Pediatric Patients **Official Title:** A Comparative Study Between General Anesthesia Versus Sedation By Dexmedetomidine and Ketamine With Local Infiltration for Percutaneous Transcatheter Closure of Atrial Septal Defect in Pediatric Patients #### Organization Study ID Info **ID:** 36264MD57/3/23 #### Organization **Class:** OTHER **Full Name:** Tanta University ### Status Module #### Completion Date **Date:** 2025-05-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Tanta University #### Responsible Party **Investigator Affiliation:** Tanta University **Investigator Full Name:** Aya Ebrahim Abdelhafez Mashal **Investigator Title:** Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The aim of the present study is to compare between general anesthesia versus sedation with dexmedetomidine and ketamine with local infilteration at the catheter insertion site in pediatric patients undergoing transcutaneous closure of atrial septal defect on hemodynamic changes. **Detailed Description:** Atrial septal defect (ASD) is one of the most common types of congenital heart defects, occurring in about 25% of children General anaesthesia is usually obtained with tracheal intubation and mechanical ventilation or spontaneous breathing, the depth of anesthesia required to tolerate the presence of a tracheal tube will invariably lead to some reduction in myocardial contractility and alteration of respiratory mechanics. The goal of anesthetic technique is to provide sedation and analgesia during cardiac catheterization to ensure immobility and hemodynamic stability. Ketamine is an N-methyl-D-aspartate receptor (NMDA) antagonist with sedative, analgesic, and sympathomimetic effects. Among its benefits ,it has the ability to protect airway reflexes with minimal effect on ventilatory drive. Dexmedetomidine is a highly selective alpha-2 adrenoreceptor agonist with sedative, anxiolytic, and analgesic effect, it also blunts the sympathetic nervous system response to surgical stimulation. ### Conditions Module **Conditions:** - General Anesthesia - Dexmedetomidine - Ketamine - Local Infiltration - Atrial Septal Defect ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### 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:** General anesthesia will be induced by 6% sevoflurane with a face mask. An intravenous line(22-g cannula )will be inserted then fentanyl 1mcg-kg will be given . Endotracheal tube will be used to intubate the patient .Anesthesia will be maintained by 2%sevoflurane inhalation in an oxygen air compination 1:1 throught the operation. Crystalloid solution was used to replenish fluid according "4/2/1-rule". Monitoring during the procedure include , ejection fraction (EF),blood pressure, heart rate, respiratory rate, and O2 saturation are measured at baseline, after induction, 10 min after catheter insertion,30 min during procedure and post emergence. **Intervention Names:** - Other: General Anesthesia **Label:** General anesthesia **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** A nasal cannula was placed and oxygen delivered at 2 to 3 L/minute. An intravenous line will be inserted (22-g cannula). The sedation regimen will include loading dose of dexmedetomidine (1 mcg/kg) and ketamine (1mg/kg) over 10 minutes . The patient will receive an infusion of dexmedetomidine at 0.7 mcg/kg per hour and ketamine 0.5 mg/kg/hr as maintenance sedation .Local infilteration of xylocaine 2% at dose 2mg/kg will be given for vascular access in cardiac catheterization . After completion of the procedure the infusion pump will be stopped to ensure that the patient is fully awake and vitally stable **Intervention Names:** - Other: Local anesthesia **Label:** Local anesthesia **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - General anesthesia **Description:** General anesthesia will be induced by 6% sevoflurane with a face mask. An intravenous line(22-g cannula )will be inserted then fentanyl 1mcg-kg will be given . Endotracheal tube will be used to intubate the patient .Anesthesia will be maintained by 2%sevoflurane inhalation in an oxygen air compination 1:1 throught the operation . Crystalloid solution was used to replenish fluid according "4/2/1-rule". Monitoring during the procedure include , ejection fraction (EF),blood pressure, heart rate, respiratory rate, and O2 saturation are measured at baseline, after induction, 10 min after catheter insertion,30 min during procedure and post emergence. **Name:** General Anesthesia **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Local anesthesia **Description:** A nasal cannula was placed and oxygen delivered at 2 to 3 L/minute. An intravenous line will be inserted (22-g cannula). The sedation regimen will include loading dose of dexmedetomidine (1 mcg/kg) and ketamine (1mg/kg) over 10 minutes . The patient will receive an infusion of dexmedetomidine at 0.7 mcg/kg per hour and ketamine 0.5 mg/kg/hr as maintenance sedation .Local infilteration of xylocaine 2% at dose 2mg/kg will be given for vascular access in cardiac catheterization . After completion of the procedure the infusion pump will be stopped to ensure that the patient is fully awake and vitally stable **Name:** Local anesthesia **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Heart rate will be measured at baseline, after induction ,10 min after catheter insertion site,30 min during procedure and post emergence in both groups. **Measure:** Heart rate **Time Frame:** Immediately after the intervention #### Secondary Outcomes **Description:** Mean arterial blood pressure will be measured at baseline, after induction ,10 min after catheter insertion site,30 min during procedure and post emergence in both groups. **Measure:** Mean arterial blood pressure **Time Frame:** Immediately after the intervention **Description:** O2 saturation will be measured at baseline, after induction ,10 min after catheter insertion site,30 min during procedure and post emergence in both groups. **Measure:** O2 saturation **Time Frame:** Immediately after the intervention **Description:** Respiratory rate will be measured at baseline, after induction ,10 min after catheter insertion site,30 min during procedure and post emergence in both groups. **Measure:** Respiratory rate **Time Frame:** Immediately after the intervention **Description:** Length of hospital stay will be measured from admission till discharge from hospital **Measure:** Lengh of hospital stay **Time Frame:** 28 days postoperative **Description:** Recovery time will be measured from the end of surgery till discharge from post-anesthesia care unit (PACU). **Measure:** Recovery time **Time Frame:** Immediately after discharge from post-anesthesia care unit **Description:** Postoperative complications such as arrythmia, hypotension, bradycardia, nausea and vomiting will be measured. **Measure:** Complications **Time Frame:** 24 hours postoperative ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged 3-8 years old. * Both genders. * American Society of Anesthesiologists (ASA) physical status II-III * Pediatric patients scheduled for elective transcatheter atrial septal defect closure. Exclusion Criteria: * Patients with multiple congenital anomalies. * Patients with congestive heart failure * Patients with Organ dysfunction liver or renal disease or pulmonary disease. * Recent chest infection. * Airway abnormalities. **Maximum Age:** 8 Years **Minimum Age:** 3 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Aya E Mashal, Master **Phone:** 00201009167298 **Role:** CONTACT #### Locations **Location 1:** **City:** Tanta **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Aya E Mashal, Master - **Phone:** 00201009167298 - **Role:** CONTACT ***Contact 2:*** - **Name:** Mohammad E Okab, MD - **Role:** SUB_INVESTIGATOR ***Contact 3:*** - **Name:** Aymen A Abd Elmaksoud Yousef, MD - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Jehan M Darwish, MD - **Role:** SUB_INVESTIGATOR **Country:** Egypt **Facility:** Aya Ebrahim Abdelhafez Mashal **State:** El-Gharbia Governorate, Egypt **Status:** RECRUITING **Zip:** 31527 ### IPD Sharing Statement Module **Access Criteria:** The data will be available upon a reasonable request from the corresponding author **Description:** The data will be available upon a reasonable request from the corresponding author after the end of study for one year. **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES **Time Frame:** After the end of study for one year. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006330 - Term: Heart Defects, Congenital - ID: D000018376 - Term: Cardiovascular Abnormalities - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000006331 - Term: Heart Diseases - ID: D000000013 - Term: Congenital Abnormalities ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M9431 - Name: Heart Septal Defects - Relevance: HIGH - As Found: Septal Defect - ID: M9432 - Name: Heart Septal Defects, Atrial - Relevance: HIGH - As Found: Atrial Septal Defect - ID: M9418 - Name: Heart Defects, Congenital - Relevance: LOW - As Found: Unknown - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M20503 - Name: Cardiovascular Abnormalities - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006343 - Term: Heart Septal Defects - ID: D000006344 - Term: Heart Septal Defects, Atrial ### Intervention Browse Module - Ancestors - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs ### 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: PhSol - Name: Pharmaceutical Solutions - Abbrev: AdjAn - Name: Adjuvants, Anesthesia - Abbrev: Analg - Name: Analgesics - Abbrev: PlAggInh - Name: Platelet Aggregation Inhibitors ### Intervention Browse Module - Browse Leaves - ID: M11014 - Name: Lidocaine - Relevance: LOW - As Found: Unknown - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: HIGH - As Found: Function - ID: M8418 - Name: Fentanyl - Relevance: LOW - As Found: Unknown - ID: M22662 - Name: Dexmedetomidine - Relevance: LOW - As Found: Unknown - ID: M10674 - Name: Ketamine - Relevance: LOW - As Found: Unknown - ID: M1673 - Name: Sevoflurane - Relevance: LOW - As Found: Unknown ### 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:** NCT06431165 **Brief Title:** Effects of Different Doses of Intravenous Lidocaine Infusion on Peri-operative Pain and Incidence of Postoperative Chronic Pain Within ERAS Protocols, a Dose Finding Study. **Official Title:** Effects of Different Doses of Intravenous Lidocaine Infusion on Peri-operative Pain and Incidence of Postoperative Chronic Pain Within ERAS Protocols, a Dose Finding Study. #### Organization Study ID Info **ID:** Pain management #### Organization **Class:** OTHER **Full Name:** Cairo University ### Status Module #### Completion Date **Date:** 2025-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-25 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cairo University #### Responsible Party **Investigator Affiliation:** Cairo University **Investigator Full Name:** Omnia Yahia El Sayed Kamel **Investigator Title:** Lecturer of anesthesiology and surgical ICU and pain management **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study aimed To investigate the effects of different doses of Intraoperative intravenous lidocaine infusion on intraoperative opioid consumption, perioperative pain control and incidence of postoperative chronic pain. **Detailed Description:** Enhanced recovery after surgery (ERAS) protocols or fast track surgery are a number of interventions which are carried out in the perioperative period. They are aimed to decrease the harmful effects of surgery on the body and help the patient recover better after surgery. ERAS has been shown to reduce the length of hospital stay, overall hospital costs, opioid consumption in the perioperative period and to reduce complication rates. One of the most important components of ERAS is adequate perioperative pain control using a multi-modal analgesic approach to help decrease dependence on opioids and provide better recovery and less postoperative hospital stay. Also, the severity and duration of acute postoperative pain is one of the predictors of chronic postsurgical pain (CPSP). Neuroplasticity (spinal sensitization) following the trauma of surgery can transform an acute pain to chronic pain if not treated effectively by aggressive management of acute pain. Lidocaine (or 2-(diethylamino)-N-(2.6-dimethylphenyl) acetamide) is the main prototype of amino-amide local anesthetics. It has analgesic, anti-hyperalgesic and anti-inflammatory properties, which enable its use as a general anesthetic adjuvant. It can reduce nociception, cardiovascular responses to surgical stress, postoperative pain, and analgesic requirements. Accordingly, Lidocaine infusion can have a role in enhancing postoperative quality of recovery, decreasing incidence of chronic postoperative pain and even increasing overall survival in patients undergoing major surgeries like in pancreatectomy. The Systemic effects of intravenous Lidocaine infusion depends on its plasma level which is affected by the rate and dose of administration, drug interactions and speed of metabolism and elimination. Around 90% of lidocaine undergoes hepatic metabolism (CYP3A4), with the production of active metabolites. During lidocaine continuous infusion, the accumulation of these metabolites may inhibit its biotransformation and might be involved in some cases of intoxication. The clearance rate of lidocaine is approximately 0.85 L/kg/h. Finally, lidocaine is eliminated by the kidney (10% of lidocaine is eliminated unchanged in the urine). The target plasma concentrations for Lidocaine for providing effective analgesia is 2.4 ± 0.6 μg/mL, while side effects as - have been reported when the plasma concentration was higher than 5-8 μg/mL. The suggested dosing regimens mentioned in literature to achieve this effective plasma level while avoiding toxicity is a bolus of 1-2 mg/kg at surgery start followed by infusion of 1-2 mg/kg/h over the duration of the surgery which is a relatively wide range, specially, considering the wide variability in type and duration of surgeries, demographics, physical and medical status of patients and type of anesthetic agents and drugs used which all can affect Lidocaine activity, elimination \& toxicity. To the best of our knowledge, no evidence exist in the literature that can point towards the ideal dosing regimen for intravenous Lidocaine infusion that can achieve the desired valuable clinical effects while decreasing the incidence of adverse side effects among the wide variety of surgeries and patients encountered within ERAS protocols. ### Conditions Module **Conditions:** - Perioperative Pain Management ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** A prospective randomized controlled double blinded study ##### Masking Info **Masking:** TRIPLE **Masking Description:** Each patient will be assigned by a randomly computer generated number to one of the 3 groups and the group assignment will be put in a sealed envelope only accessible by the investigator responsible for preparing the drug syringes. The patient and data collectors will be blinded to the patient group allocation as well as the managing anesthiologists during the operation **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 69 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Group A: Bolus 10 ml Syringe with Lidocaine 0.5% (2.5 ml lidocaine 2% + 7.5 ml N.S), and infusion 50 ml Syringe with Lidocaine 0.5% (12.5 ml Lidocaine 2% + 37.5 ml N.S). **Intervention Names:** - Drug: Lidocaine IV **Label:** Group A **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Group B: Bolus 10 ml Syringe with Lidocaine 1% (5 ml lidocaine 2% + 5 ml N.S), and infusion 50 ml Syringe with Lidocaine 1% (25 ml Lidocaine 2% + 25 ml N.S). **Intervention Names:** - Drug: Lidocaine IV **Label:** Group B **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Group C: Bolus 10 ml Syringe with plain Lidocaine 2%, and infusion 50 ml Syringe with plain Lidocaine 2%. **Intervention Names:** - Drug: Lidocaine IV **Label:** Group C **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group A - Group B - Group C **Description:** After confirming patient history, type of operation and patient group allocation, standard ASA monitoring will be attached to the patient then the I.V induction of anesthesia will be commenced using standard doses of Propofol \&Tracrium in addition to 1 μg/kg Fentanyl and 1 ml/10 kg from the bolus Lidocaine syringe followed after 3 minutes by endotracheal intubation, then the Lidocaine infusion Syringe will be attached to a separate I.V line at an infusion rate of 1 ml/10 kg/h. The patient will receive 1 gm of I.V paracetamol and the surgery will be allowed to proceed. **Name:** Lidocaine IV **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Fentanyl doses of 0.5 mic/kg will be given when there is increase in hemodynamics by 20% of baseline and this will be reported **Measure:** Total Intraoperative opioid consumption (Fentanyl) **Time Frame:** Every five minutes #### Secondary Outcomes **Measure:** Total opioid consumption (Morphine) in the first 24 hours postoperative. **Time Frame:** Every one hour postoperative for 24 hours **Description:** Time between end of surgery and the first dose of rescue analgesia administered to the patient **Measure:** Time of first rescue analgesia used in the first 24 hours postoperative **Time Frame:** Every one hour postoperative for 24 hours **Measure:** Incidence of side effects related to Lidocaine infusion during the first 24 hours postoperative. **Time Frame:** Every one hour postoperative for 24 hours **Measure:** Incidence of chronic postoperative pain 2 months after the surgery. **Time Frame:** Every week for 2 months postoperative. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients age between 18 and 65. * Patients with ASA I and II status. * Patients undergoing open laparotomy surgeries (including open cholecystectomies). Exclusion Criteria: * Patients unable to comprehend the informed consent. * Patients on long term pre-operative opioid regimens. * Patients with impairment in hepatic or renal functions. * Patients who are planned to receive any form of regional block for the surgery. **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:** Alaa Magdy Ahmed Hassan, Master **Phone:** 01090282616 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Amany Ezzat Ayad Ibrahim, Professor **Phone:** 01223429325 **Role:** CONTACT #### Locations **Location 1:** **City:** Cairo **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Omnia Y Kamel, MD - **Phone:** 01270130326 - **Role:** CONTACT **Country:** Egypt **Facility:** Cairo University **Status:** RECRUITING **Zip:** 1111 #### Overall Officials **Official 1:** **Affiliation:** Cairo University **Name:** Mohammed Ahmed Mansour, Assistant professor **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Cairo University **Name:** Islam Ayman Mohammed Shawky, MD **Role:** STUDY_DIRECTOR **Official 3:** **Affiliation:** Cairo University **Name:** Nora Amr Agiza, MD **Role:** STUDY_DIRECTOR **Official 4:** **Affiliation:** Cairo University **Name:** Omnia Y Kamel, MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## 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 ### 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 - ID: D000000889 - Term: Anti-Arrhythmia Agents - ID: D000061567 - Term: Voltage-Gated Sodium Channel Blockers - ID: D000026941 - Term: Sodium Channel Blockers - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### 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: AdjAn - Name: Adjuvants, Anesthesia - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M11014 - Name: Lidocaine - Relevance: HIGH - As Found: Solution - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M8418 - Name: Fentanyl - Relevance: LOW - As Found: Unknown - ID: M18307 - Name: Propofol - Relevance: LOW - As Found: Unknown - ID: M4584 - Name: Atracurium - Relevance: LOW - As Found: Unknown - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown - ID: M4213 - Name: Anti-Arrhythmia Agents - Relevance: LOW - As Found: Unknown - ID: M23177 - Name: Sodium Channel Blockers - Relevance: LOW - As Found: Unknown - ID: M30025 - Name: Diuretics, Potassium Sparing - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000008012 - Term: Lidocaine ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431152 **Acronym:** EXO-OA01 **Brief Title:** Intra-articular Injection of UC-MSC Exosome in Knee Osteoarthritis **Official Title:** Administration of sEV Derived From UC-MSC in Patients With Osteoarthritis of the Knee: Safety Determination in a Pilot Dose-escalation Study #### Organization Study ID Info **ID:** EXO-OA01 #### Organization **Class:** OTHER **Full Name:** Universidad de los Andes, Chile ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** 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:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universidad de los Andes, Chile #### 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 aim to evaluate safety of exosomes (sEVs) from allogeneic mesenchymal stromal cells delivered by an intra-articular injection in the knee of patients with mild to moderate symptomatic osteoarthritis. The sEVs will be produced in a GMP-facility. The investigators expect to enroll 12 patients in this phase 1 trial open label dose-escalation pilot and the follow-up will be up to 12 months. **Detailed Description:** The clinical investigation will represent a Phase 1 trial focusing on small extracellular vesicles derived from mesenchymal stem cell (MSC-sEV) in patients with symptomatic Kellgren II-III knee OA. The phase 1 component of the study will be an open-label dose escalation pilot study in which three cohorts of subjects with OA will receive increasing doses of UC-MSC-sEV administered as a single intra-articular (IA) injection. Each cohort will comprise four participants. Eligible study subjects will be enrolled at the "Clinica Universidad de los Andes". The small extracellular vesicles derived from umbilical cord mesenchymal stem cell (UC-MSC-sEV) will be prepared in the "Clinica Universidad de los Andes" GMP facility. The sEV-based therapeutic for clinical use will be manufactured in compliance with standardized procedures based on Good Manufacture Practice (GMP) regulations and all quality controls aforementioned. The sEV therapeutic will be transported to the patient administration site under controlled conditions, ensuring maintenance of a temperature range between 2-8°C. The sEV injection is expected to be administered within the first 6 h of product manufacture. The primary study endpoints of this trial will focus on the safety, feasibility, and toxicity of the sEV-based product. The phase I will examine (1) the incidence of immediate post-infiltration adverse reactions in patients; (2) the occurrence of synovitis post-infiltration in patients at 24 and 48 hours, as well as on days 7 and 15; (3) the frequency of post-infiltration pain reported by patients at 24 and 48 h, and on days 7 and 15; and (4) the prevalence of adverse events related to sEV therapy occurring beyond IA infiltration at 24 and 48 h, and on days 7 and 15, as well as at months 2, 4, 6, 8, 10, and 12. The secondary study endpoint will be determine the optimal dose for phase II trials. The criteria that will be considered are (1) Safety profile at infiltration at 24 and 48 h, and on days 7 and 15, as well as at months 2, 4, 6, 8, 10, and 12; (2) changes in WOMAC scores at months 2, 4, 6, 8, 10, and 12; and (3) alterations in the Visual Analog Scale (VAS) pain scores at months 2, 4, 6, 8, 10, and 12. ### Conditions Module **Conditions:** - Osteo Arthritis Knee ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 12 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Intra-articular knee injection of exosomes (2 x 10e9 particles/dose) derived from allogeneic mesenchymal stromal cells. Single dose. 4 patients **Intervention Names:** - Biological: UC-MSC sEV **Label:** Low-Dose **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Intra-articular knee injection of exosomes (6 x 10e9 particles/dose) derived from allogeneic mesenchymal stromal cells. Single dose. 4 patients **Intervention Names:** - Biological: UC-MSC sEV **Label:** Medial-Dose **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Intra-articular knee injection of exosomes (2 x 10e10 particles/dose) derived from allogeneic mesenchymal stromal cells. Single dose. 4 patients **Intervention Names:** - Biological: UC-MSC sEV **Label:** High-Dose **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - High-Dose - Low-Dose - Medial-Dose **Description:** Small extracellular vesicles derived from allogenic mesenchymal stromal cells, single dose **Name:** UC-MSC sEV **Other Names:** - Cellistem®sEV-OA **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Occurrence of any adverse reactions within 12 months of treatment **Measure:** Adverse Event **Time Frame:** 12 month #### Secondary Outcomes **Description:** Pain measured by Visual Analogue Scale (VAS) (0-100mm) after first week of treatment **Measure:** Incidence of injection-related pain according to Visual Analogue Scale (VAS) (0-100mm) **Time Frame:** 1-2 weeks **Description:** Synovitis measured by effusion grading scale (zero to 3+) after first week of treatment **Measure:** Incidence of injection-related synovitis according to effusion grading scale of knee joint **Time Frame:** 1-2 weeks **Description:** Change in Visual Analogue Scale (VAS) (0-100mm) score every 2 months **Measure:** Pain change **Time Frame:** 12 months **Description:** Change in WOMAC subscale (Western Ontario and McMaster Universities Osteoarthritis IndexWomac) related to function (C) every 2 months Pain (0-20), Stiffness (0-8), functional capacity (0-68). **Measure:** Disability change **Time Frame:** 12 months **Description:** According to OMERACT-OARSI Criteria Index Response after 52 weeks **Measure:** Percentage of responders **Time Frame:** 52 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 30 to 70 years. * Kellgren-Lawrence grade II - III knee OA (Rosenberg view x-ray) * VAS for pain ≥ 40 mm, without surgical indication in the affected knee. * In case of bilateral involvement, the most affected knee will be treated. The contralateral knee should be asymptomatic or present a VAS ≤ 20 mm. * Stable knee with normal physical examination. * Signed Informed Consent Exclusion Criteria: * Symptomatic bilateral knee OA * BMI \> 30 kg/m2 * Joint instability at physical examination. * Mechanical meniscal tear on physical examination. * Associated conditions: active local or systemic infection, neoplasia, immunosuppression, pregnancy, anticoagulant therapy, coagulation disorders, inflammatory joint disease (autoimmune, by crystal or other), joint prosthesis, symptomatic spine or hip disease. * Recent use of intra-articular (last 6 months) or oral (last month) steroid therapy. * Recent use of intra-articular hyaluronic acid therapy (last 6 months) * Subchondral bone fracture. **Maximum Age:** 70 Years **Minimum Age:** 30 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jose Matas, MD **Phone:** +56 2 26183347 **Phone Ext:** 3347 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Francisco Espinoza, MD **Phone:** +56 2 26183347 **Phone Ext:** 3347 **Role:** CONTACT #### Locations **Location 1:** **City:** Santiago **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Bernardita Hurtado - **Phone:** 226182071 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Consuelo Covarrubias - **Phone:** 226182071 - **Role:** CONTACT **Country:** Chile **Facility:** Clinica Universidad de los Andes **State:** Las Condes **Status:** RECRUITING **Zip:** 2501 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M22168 - Name: Osteoarthritis, Knee - Relevance: HIGH - As Found: Osteo Arthritis Knee - ID: M12926 - Name: Osteoarthritis - Relevance: HIGH - As Found: Osteo Arthritis - ID: M4476 - Name: Arthritis - 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: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010003 - Term: Osteoarthritis - ID: D000020370 - Term: Osteoarthritis, Knee ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431139 **Acronym:** INSPIRE **Brief Title:** Intensive Physical Exercise Versus Standard Exercise During Rehabilitation of Patients With Traumatic Brain Injury **Official Title:** Intensive Physical Exercise Versus Standard Exercise During Rehabilitation of Patients With Traumatic Brain Injury - a Randomised Pilot and Feasibility Trial #### Organization Study ID Info **ID:** H-24001505 #### Organization **Class:** OTHER **Full Name:** Rigshospitalet, Denmark ### Status Module #### Completion Date **Date:** 2026-01-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-10-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Christian Riberholt #### Responsible Party **Investigator Affiliation:** Rigshospitalet, Denmark **Investigator Full Name:** Christian Riberholt **Investigator Title:** Head of therapy and senior researcher, PT, MR, PhD **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of this randomised multicentre clinical feasibility and pilot trial is to test if a sit-to-stand trial protocol is feasible regarding the increased intensity, trial recruitment, and completion of outcome data in patients with moderate to severe traumatic brain injury during the rehabilitation phase. For the trial to be feasible, all outcomes must be achieved. The primary hypothesis is that it is feasible to progressively increase the number of repetitions of sit-to-stand exercises in patients with moderate to severe traumatic brain injury admitted to a rehabilitation department during the intervention period. Furthermore, the investigators hypothesize that the increased number of repetitions will increase the participant's functional capabilities regarding sit-to-stand and walking, decrease resting heart rate, blood pressure, and metabolism, reduce inflammatory and brain injury biomarkers, and improve the cognitive performance. **Detailed Description:** This is a randomised multicentre clinical feasibility and pilot trial, where assessors and statisticians will be blinded. Forty-four participants with moderate to severe traumatic brain injury will be randomised to INSPIRE versus standard care as soon as they are able to understand and execute simple commands twice during one day. Participants in the INSPIRE group will undergo two weeks of intensive sit-to-stand exercise using an algorithm to increase the intensity daily. The trial uses predefined dose-limiting events to reduce training intensity in participants experiencing exercise-related adverse events that limit other daily activities and rehabilitation (e.g. muscle soreness and pain). Overall feasibility will be assessed by determining the inclusion rate, exercise completion rate, and completion of the Glasgow Outcome Scale - Extended. As exploratory clinical outcomes, the investigators will assess serious adverse events and adverse events not considered serious, physical function, cardiovascular and metabolic health, fatigue, and cognitive function. ### Conditions Module **Conditions:** - Traumatic Brain Injury **Keywords:** - Traumatic brain injury - Intensive exercise - Rehabilitation - Randomised trial - Feasibility - Pilot - Sit-to-stand exercise ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Masking Description:** The trial will use assessors blinded to the allocation and in charge of testing the following outcomes: 30 seconds chair stand test, 10-meter walk test, 6-minute walking test, and the Montreal Cognitive Assessment Scoring (MoCA) Two statisticians that will perform the statistical analysis are blinded to the allocation **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 44 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Intervention group. Daily intensive sit-to-stand exercises following a described algorithm and utilising motor-relearning principles of feedback to increase the participant's motivation. This exercise is an addition to standard care. **Intervention Names:** - Other: INSPIRE intervention protocol **Label:** INSPIRE group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Treatment in this group will be standard care interventions performed at the rehabilitation department. **Label:** Standard care group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - INSPIRE group **Description:** 2-week training program with daily sit-to-stand exercises. Each working day the participant's goals will be adjusted, until exercising a minimum of 100 repetitions using an exercise progression table. When participants complete one level, they will progress to the next level the following day. Participants who do not reach the goals at level one will continue to strive to reach the 100 repetitions. The number of repetitions can be split and performed throughout the day. As the participants' capacity for doing the exercises increases, so will the number of repetitions within each bout of sit-to-stand. Participants are allowed to do the number of repetitions from a higher exercise level if they can and will continue by progressing from that level on the next day. The repetitions will be done from a height that makes it possible to accomplish the sit-to-stand movement. Therefore, the height of the sitting surface will be adjusted according to the participant's abilities. **Name:** INSPIRE intervention protocol **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Examples of this could be fatigue or muscle pain that limits the participant in other activities of daily living and thereby reduces their amount of other rehabilitation services during the day **Measure:** Dose-limiting events **Time Frame:** during the intervention, 72-hours after end of intervention **Description:** The scale is a global scale evaluating the independent function after traumatic brain injury. **Measure:** Glasgow Outcome Scale - Extended **Time Frame:** at discharge, 6 months, 1 year **Description:** The total number of sit-to-stands in each group will be measured using an activity monitor placed on the participant's sternum and hip (Sens motion®, Copenhagen, Denmark) **Measure:** Number of sit-to-stand exercises in each group during the intervention period (continuous outcome) **Time Frame:** during the intervention **Description:** The test is administered using a stopwatch and a chair. The participant is instructed to do sit-to-stand movements for 30 seconds. Time begins when the participant initiates the movement. **Measure:** Number of sit-to-stand exercises during the 30-second chair stand test (continuous outcome) **Time Frame:** Baseline, 1 day after the intervention **Description:** Walkers are defined by the ability to walk at any pace, with any walking aid, over minimum 50 meters independently (i.e. independent from physical assistance). **Measure:** Walkers and non-walker (dichotomous outcome) **Time Frame:** Baseline, 1 day after the intervention **Description:** The walkers in each group will undergo a 10-meter walk test to assess walking speed **Measure:** 10-meter walk test (continuous outcome) **Time Frame:** Baseline, 1 day after the intervention **Description:** The walkers in each group will undergo a 6-minute walking test to assess and endurance **Measure:** 6-minute walking test (continuous outcome) **Time Frame:** Baseline, 1 day after the intervention **Description:** Resting blood pressure will be measured on both arms for 5 minutes continuously before the first training session (8 am) using photoplethysmography to measure beat-to-beat blood pressure non-invasively. **Measure:** Resting blood pressure **Time Frame:** Baseline, 1 day after the intervention **Description:** An ordinary electrocardiogram available at the respective departments will be used to measure resting heart rate. **Measure:** Resting heart rate **Time Frame:** Baseline, 1 day after the intervention **Description:** The blood samples will be analysed for high-sensitivity C-reactive protein, neutrophil-to-lymphocyte ratio, HbA1c, blood glucose, c-peptide insulin, blood lipids, inflammatory biomarkers, neuronal cell injury biomarkers, astroglia cell injury biomarkers, and axonal injury biomarkers. Finally, biomarkers associated with subacute/chronic traumatic brain injury phase will be analysed. **Measure:** Blood samples **Time Frame:** Baseline, 1 day after the intervention **Description:** The MoCA is a short cognitive questionnaire designed to test for mild cognitive impairments. **Measure:** The Montreal Cognitive Assessment (MoCA) **Time Frame:** Baseline, 1 day after the intervention, 6 months, 1 year **Description:** The Fatigue Severity Scale examines the severity of fatigue with a 9-item scale, and how it can affect a person's daily lifestyle when they have a chronic disease/disorder. **Measure:** Fatigue severity scale (FSS) **Time Frame:** Baseline, 1 day after the intervention, 6 months, 1 year #### Primary Outcomes **Description:** The difference in the number of sit-to-stand performed in the INSPIRE group compared to the control group using linear regression during the two-week intervention period. **Measure:** Number of sit-to-stand **Time Frame:** during the intervention #### Secondary Outcomes **Description:** Of all eligible patients, at least 76% (95% CI 63% to 86%, 1-sample proportions test with continuity correction) must consent (by themselves or by proxy) to inclusion in the trial, corresponding to 44/58 eligible patients included **Measure:** The number of participants included in the trial **Time Frame:** 1,5 years **Description:** The number of participants completing the Glasgow Outcome Scale extended at six months and one year must be above 89% (95% CI 76% to 96%), corresponding to 40/44 participants. **Measure:** Participants completing GOSE **Time Frame:** 6 months, 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Moderate to severe traumatic brain injury with Glasgow Coma Score \<13 within the first 24 hours (ICD10, DS06) * Admitted for rehabilitation at the Department of Brain and Spinal Cord Injury, Division of Brain Injury, Rigshospitalet, the Regional Hospital, Hammel Neurocentre or the Acquired Brain Injury Rehabilitation Centre, Alfred Hospital * 18 years old or older * Patients (or next of kin) should be able to understand written and spoken Danish or English to consent to participation in the trial validly * Specifically for Australian participants: eligibility for Medicare Exclusion Criteria: * Unstable fractures of the lower extremities * Amputation of lower extremity * Spinal cord injury * Total paralysis of both lower extremities * Agitated or combative behaviour * Diagnosed with a progressive neurological disorder (e.g. Alzheimer's, Parkinson's disease, multiple sclerosis) prior to traumatic brain injury, as it could potentially interfere with serum biomarker levels * Previous structural brain injury (e.g. stroke or brain surgery) * No valid consent from the participant or next of kin **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yasemin Ronahi Kücük, M.D **Phone:** +4527841237 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Christian G Riberholt, PT, MR, PhD **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Dept. of Brain and Spinal Cord Injury, Division of Brain Injury, Copenhagen University Hospital - Rigshospitalet **Name:** Christian G Riberholt, PT, MR, PhD **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Dept. of Brain and Spinal Cord Injury, Division of Brain Injury, Copenhagen University Hospital - Rigshospitalet **Name:** Christina G Kruuse, Professor **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000006259 - Term: Craniocerebral Trauma - ID: D000020196 - Term: Trauma, Nervous System ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5207 - Name: Brain Injuries - Relevance: HIGH - As Found: Brain Injury - ID: M628 - Name: Brain Injuries, Traumatic - Relevance: HIGH - As Found: Traumatic Brain Injury - ID: M17685 - Name: Wounds and Injuries - Relevance: HIGH - As Found: Injury - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M9349 - Name: Craniocerebral Trauma - Relevance: LOW - As Found: Unknown - ID: M22023 - Name: Trauma, Nervous System - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001930 - Term: Brain Injuries - ID: D000070642 - Term: Brain Injuries, Traumatic - ID: D000014947 - Term: Wounds and Injuries ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431126 **Brief Title:** Animal-assisted and Nature Based Activities **Official Title:** Animal-assisted and Nature Based Activities for Young Adults With Autism and Social Withdrawel #### Organization Study ID Info **ID:** RK-997623 #### Organization **Class:** OTHER_GOV **Full Name:** Kronoberg County Council ### Status Module #### Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2023-07-07 **Type:** ACTUAL #### Start Date **Date:** 2020-09-24 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Kronoberg County Council #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Neuropsychiatric impairments in young adults are common and can involve social withdrawal, and difficulties in receiving support from healthcare and municipal social care services. Collaboration is needed, but knowledge gaps exist concerning effective interventions. Participation in meaningful activities, as a complement to other treatment strategies can be a step towards studies/work. The aim of the trial is to explore the feasibility of a structured nature and animal-based activity on a farm for young adults with neuropsychiatric impairments. The intervention involves participation in nature and animal-assisted group activities, twice a week for 12 weeks. Data consists of interviews with participants prior to and after the intervention, as well as one year later. The one-year follow-up focus is on life situation, changes in everyday life and experiences of the intervention. In addition, interview-based experiences of the ordinary staff and supervisors on the farm are included. Analysis will be carried out with qualitative content analysis, as well as health-economic calculations. ### Conditions Module **Conditions:** - Neuropsychiatric Syndrome - Autism Spectrum Disorder **Keywords:** - complementary therapies - feasability - young adults ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 13 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Animal-assisted and nature based activities **Label:** Animal-assisted and nature based group activity for young adults with autism **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Animal-assisted and nature based group activity for young adults with autism **Description:** Supervised activities on a farm, 2 half day/week for 12 weeks **Name:** Animal-assisted and nature based activities **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Number of sessions with participation **Measure:** Attendance **Time Frame:** 12 weeks #### Secondary Outcomes **Description:** Interviews **Measure:** Experiences of participation **Time Frame:** 12 weeks **Description:** Interview **Measure:** Occupational level **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18-30 years * Autism Spectrum Disorder * Social withdrawn at least for one year * Social insurance benefits * Interest in being with animals Exclusion Criteria: * Ongoing drug abuse * Severe psychiatric comorbidity **Maximum Age:** 30 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Växjö **Country:** Sweden **Facility:** Kronoberg County Council **Zip:** 35242 #### Overall Officials **Official 1:** **Affiliation:** Kronoberg County Council **Name:** Birgitta Gunnarsson, PhD **Role:** PRINCIPAL_INVESTIGATOR ## 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 - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M4623 - Name: Autistic Disorder - Relevance: LOW - As Found: Unknown - ID: M206 - Name: Autism Spectrum Disorder - Relevance: HIGH - As Found: Autism Spectrum Disorder - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - 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 ### Condition Browse Module - Meshes - ID: D000067877 - Term: Autism Spectrum Disorder ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431113 **Brief Title:** Effect of Fixed Combination Citicoline Homotaurine and Pyrroloquinoline Quinone on Pattern-electroretinogram in Glaucoma **Official Title:** Effect of Fixed Combination Citicoline 500 mg, Homotaurine 50 mg, Pyrroloquinoline Quinone (Neuprozin Mito®) on Pattern Electroretinogram in Controlled Open Angle Glaucoma Patients:A Multicenter, Randomized, Single Blind, Cross-over Study #### Organization Study ID Info **ID:** NP-MITO #### Organization **Class:** OTHER **Full Name:** IRCCS Policlinico S. Matteo ### Status Module #### Completion Date **Date:** 2025-05-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-04-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-27 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Federico II University **Class:** OTHER **Name:** University of Roma La Sapienza #### Lead Sponsor **Class:** OTHER **Name:** IRCCS Policlinico S. Matteo #### Responsible Party **Investigator Affiliation:** IRCCS Policlinico S. Matteo **Investigator Full Name:** Rossi, Gemma Caterina Maria **Investigator Title:** Principal investigator, Ophthalmologist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to examine the effect of the fixed combination Citicoline 500 mg, Homotaurine 50 mg, Pyrroloquinoline quinone (PQQ) disodium salt (Neuprozin Mito®) on pattern electroretinogram (PERG) in patients with primary open angle glaucoma on well controlled intraocular pressure It will also learn about the safety of this fixed combination. The main questions it aims to answer are: Does the fixed combination Citicoline 500 mg, Homotaurine 50 mg, Pyrroloquinoline quinone (PQQ) disodium salt (Neuprozin Mito®) improve PERG amplitude and/or latency? Does the fixed combination act as neuromodulator in glaucoma patients based on electrophysiology? Does the fixed combination improve quality of life of glaucoma patients? Does the fixed combination have any effect on optical coherence tomography (OCT)? Researchers will compare the fixed combination Citicoline 500 mg, Homotaurine 50 mg, Pyrroloquinoline quinone (PQQ) disodium salt (Neuprozin Mito®) to citicoline 800 mg to see if the fixed combination works better than citicoline alone as neuroprotective agent in glaucoma. Participants will: Take the fixed combination or citicoline alone every day for 4 months After 4 months patients will be crossed over to the other treatment for 4 months. Visit the clinic at enrollment and once every 4 months (at month 4 and at month 8) for checkups and tests (visual field, OCT, PERG and quality of life questionnaire) **Detailed Description:** Our general purpose is to evaluate the potential beneficial effects of supplementation of a fixed combination of Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone on retinal ganglion cells (RGCs) function in subjects with glaucoma by pattern electroretinogram. Primary objective To compare the effects of adding the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone (Neuprozin Mito® - NPM) a tablet a day on PERG examination (p50 wave) at four months of therapy, compared to citicoline 800 mg alone (Cebrolux® - CIT), as add-on to standard topical therapy. Secondary objectives To compare the two treatments (Neuprozin Mito® - NPM vs citicoline - CIT - alone) in terms of: * visual acuity over time * visual field changes over time, if any * Quality of Life perception (National Eye Institute-Visual function questionnaire 25 item -NEI VFQ25 questionnaire) over time * optical coherence tomography - OCT- changes over time, if any * Safety (Incidence of adverse events) Study design and planning Multicentric, randomized, 2-sequence, 2-period, 2-treatment, crossover study, with blind outcome assessor. Centers 1. Azienda Ospedaliera Universitaria Federico II ; UOC Oculistica, Napoli 2. Clinica Oculistica dell'Università degli Studi di Pavia, IRCCS Policlinico San Matteo Foundation, Pavia. 3. Dipartimento di Scienze Medico-Chirurgiche e Medicina Traslazionale, Università di Roma "Sapienza", Roma Study duration Study duration ; 14 months Enrolment period: 6 months Minimum Follow-up: 8 months Total sample size: 40 patients ### Conditions Module **Conditions:** - Glaucoma - Neuroprotection **Keywords:** - glaucoma - neuroprotection - citicoline - homotaurine - Pyrroloquinoline quinone - visual field - pattern electroretinogram - oct - quality of life ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone (Neuprozin Mito® - NPM) fixed combination for 4 months followed by Cebrolux -CIT for 4 months, besides standard topical treatment **Intervention Names:** - Combination Product: Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone (Neuprozin Mito® ) **Label:** Citicoline 500 mg+Homotaurine 50 mg+Pyrroloquinoline quinone (Neuprozin Mito®-NPM) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Citicoline 800 (Cebrolux-CIT) for 4 months followed by Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone (Neuprozin Mito® - NPM) for 4 months, besides standard topical treatment **Intervention Names:** - Combination Product: Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone (Neuprozin Mito® ) **Label:** Cebrolux -CIT for 4 months **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Cebrolux -CIT for 4 months - Citicoline 500 mg+Homotaurine 50 mg+Pyrroloquinoline quinone (Neuprozin Mito®-NPM) **Description:** treatment for 4 months and then cross over to the other therapy **Name:** Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone (Neuprozin Mito® ) **Type:** COMBINATION_PRODUCT ### Outcomes Module #### Primary Outcomes **Description:** amplitude of PERG waves (microVolt) **Measure:** To compare the effects of adding the fixed combination of Citicoline 500 mg+Homotaurine 50 mg+Pyrroloquinoline quinone (Neuprozin Mito® - NPM) on pattern-electroretinogram -PERG- amplitudes **Time Frame:** 4 months **Description:** latency of PERG waves (milliseconds) **Measure:** To compare the effects of adding the fixed combination of Citicoline 500 mg+Homotaurine 50 mg+Pyrroloquinoline quinone (Neuprozin Mito® - NPM) on PERG latencies **Time Frame:** 4 months #### Secondary Outcomes **Description:** visual acuity evaluation **Measure:** To compare the two treatments in terms of: • visual acuity over time **Time Frame:** 4 months **Description:** Pattern Standard Deviation and Mean Deviation (deciBell) **Measure:** To compare the two treatments in terms of: • visual field changes over time, if any **Time Frame:** 4 months **Description:** quality of life with questionnaire national eye institute-visual function questionnaire 25 items (NEI-VFQ25) (from 0=worst score/quality of life to 100 better score/quality of life) **Measure:** To compare the two treatments in terms of: • Quality of Life perception national eye institute-visual function questionnaire 25 items (NEI VFQ25) over time **Time Frame:** 4 months **Description:** retinal nerve fiber layer (RNFL) and ganglion cells complex (GCC) **Measure:** To compare the two treatments in terms of: • optical coherence tomography - OCT changes over time, if any **Time Frame:** 4 months **Description:** adverse events onset **Measure:** To compare the two treatments in terms of: • Safety (Incidence of adverse events) **Time Frame:** 8 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * age \> 18 years; * diagnosis of primary OAG (POAG) from, at least, 3 years; * visual acuity \> 0.7 (7/10) decimals; * refractive error \< 5 Diopter (D) (spheric) and \< 2D (toric); * transparent diopter means (cornea and lens); * controlled intraocular pressure (IOP) (\<18 mmHg, morning value) with prostaglandin analogues as monotherapy; * stable intraocular pressure - IOP \< 18 mmHg in the last 2 years; * stable and unchanged topical therapy in the last 6 months; * at least two reliable visual fields (Humphrey 24-2 Swedish interactive threshold algorithm-SITA Standard) per year in the last 2 years; * early to moderate visual field defect (mean deviation, MD \<12 dB); * electrophysiological (pattern electroretinogram-PERG) parameters alterations similar to glaucomatous pathology; * written consent to participate to study procedures and data utilization in an anonymous form Exclusion Criteria: * ocular hypertension with normal optic nerve and visual field; angle closure glaucoma; congenital glaucoma; secondary glaucoma; normal tension glaucoma; * history of recurrent uveitis/scleritis/herpes infection; * pregnancy and breastfeeding; * contraindication to Citicoline and/or Homotaurine and/or pyrroloquinoline quinone -PQQ * contraindication to prostaglandine analogues * topical therapy with Brimonidine or beta-blockers as monotherapy or fixed combination * topical therapy with pilocarpine and aceclidine, monotherapy or fixed combination * systemic or topical treatment with another neuroprotective agent in the last 4 months prior to enrollment * systemic betablockers * systemic therapies affecting patients' performance in visual field examination (sedatives); * glaucomatous scotomas within 10 degree from fixation * any condition limiting the patient's ability to participate in the study; * other ocular causes of visual field and PERG changes, such as cataract, myopic chorioretinopathy, macular diseases, retinal vascular occlusion, diabetic retinopathy; * other systemic causes of visual field and PERG changes such as neurodegenerative disorders (Alzheimer's disease, Parkinson's disease, acute lateral sclerosis, multiple sclerosis) or pituitary disorders; * cerebral ischemia in the last 2 years * any change in topical therapy in the 6 months prior to enrollment or during the study period * concomitant participation to another clinical trial * any previous filtering and/or retinal surgery; * cataract surgery in the last 6 months; * any previous laser treatment for glaucoma in the last 5 years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Gemma Caterina Maria Rossi, MD **Phone:** +393284838186 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Gemma Caterina Maria Rossi, MD **Phone:** 3284838186 **Role:** CONTACT #### Locations **Location 1:** **City:** Pavia **Country:** Italy **Facility:** Gemma Caterina Maria Rossi **State:** PV **Status:** ACTIVE_NOT_RECRUITING **Zip:** 27100 **Location 2:** **City:** Napoli **Contacts:** ***Contact 1:*** - **Name:** Ciro Costagliola, MD - **Role:** CONTACT **Country:** Italy **Facility:** Clinica Oculistica Università Federico II **Status:** RECRUITING **Zip:** 80100 #### Overall Officials **Official 1:** **Affiliation:** Federico II University eye Clinic, Naples **Name:** Ciro Costagliola, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009798 - Term: Ocular Hypertension - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9013 - Name: Glaucoma - Relevance: HIGH - As Found: Glaucoma - ID: M9014 - Name: Glaucoma, Open-Angle - Relevance: LOW - As Found: Unknown - ID: M10024 - Name: Hypertension - Relevance: LOW - As Found: Unknown - ID: M12731 - Name: Ocular Hypertension - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005901 - Term: Glaucoma ### Intervention Browse Module - Ancestors - ID: D000018697 - Term: Nootropic Agents - ID: D000000927 - Term: Anticonvulsants - ID: D000018755 - Term: GABA Agonists - ID: D000018682 - Term: GABA Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: AntiConv - Name: Anticonvulsants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: NootAg - Name: Nootropic Agents - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: Lipd - Name: Lipid Regulating Agents - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M211514 - Name: Tramiprosate - Relevance: HIGH - As Found: Biodiversity - ID: M6771 - Name: Cytidine Diphosphate Choline - Relevance: HIGH - As Found: Fail - ID: M6034 - Name: Choline - Relevance: LOW - As Found: Unknown - ID: M20774 - Name: Nootropic Agents - Relevance: LOW - As Found: Unknown - ID: M4246 - Name: Anticonvulsants - Relevance: LOW - As Found: Unknown - ID: M20825 - Name: GABA Agonists - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: T443 - Name: Choline - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000001355 - Term: Tramiprosate - ID: D000003566 - Term: Cytidine Diphosphate Choline ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431100 **Acronym:** GK-01 **Brief Title:** a Single-arm, Single-center, Open Clinical Study **Official Title:** Clinical Study on the Safety and Efficacy of GK01 Autologous Tumor-reactive T Cells (TRT) in Patients With Advanced Solid Tumors #### Organization Study ID Info **ID:** GK-01 #### Organization **Class:** INDUSTRY **Full Name:** Beijing Geekgene Technology Co., LTD ### Status Module #### Completion Date **Date:** 2026-11-19 **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:** 2026-07-19 **Type:** ESTIMATED #### Start Date **Date:** 2023-07-19 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Beijing Geekgene Technology Co., LTD #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This trial plans to enroll many patients with advanced solid tumors to complete GK01 cell transfusion, including but not limited to advanced gastric cancer, esophageal cancer, cervical cancer, triple-negative breast cancer, and non-small cell lung cancer. For patients with advanced solid tumors eligible for inclusion, autologous tumor-reactive T cells (experimental drug GK01) were cultured and prepared, and a certain dose of GK01 cells was given according to the cell transfusion plan, and the safety and tolerability of the patients after transfusion were observed. Exploratory evaluation of pharmacokinetic/pharmacodynamic profiles following reinfusion and initial evaluation of efficacy of investigational drug GK01 cells according to RECIST 1.1 criteria. ### Conditions Module **Conditions:** - Gastric Cancer - Esophageal Cancer - Cervical Cancer - Non-Small Cell Lung Cancer NSCLC - Triple Negative Breast Cancer TNBC **Keywords:** - TRT - cell therapy - advanced tumor - safety - efficiency - adverse event ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 36 Months ### Arms Interventions Module #### Arm Group 1 **Description:** According to the cell transfusion protocol, GK01 cells were given at a certain dose level to observe the safety and tolerability of the patients after the transfusion, explore the pharmacokinetic/pharmacodynamic characteristics after the transfusion, and preliminarily evaluate the effectiveness of the experimental drug GK01 cells according to the RECIST 1.1 standard. **Intervention Names:** - Biological: TCR T-cells **Label:** cell therapy interventional single arm ### Interventions #### Intervention 1 **Arm Group Labels:** - cell therapy interventional single arm **Description:** The strengthened T cells are re-infused into the patient to achieve the killing effect **Name:** TCR T-cells **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** To evaluate the safety and tolerability of GK01 autologous tumor-reactive T cells (TRT) in patients with advanced solid tumors. **Measure:** safety and tolerability **Time Frame:** From enrollment to the end of follow-up visit at 22weaks or more #### Secondary Outcomes **Description:** To explore the specificity and persistence of GK01 autologous tumor-reactive T cells (TRT) expansion in patients with advanced solid tumors **Measure:** specificity and persistence **Time Frame:** From enrollment to the end of treatment at 28 days **Description:** To evaluate the initial efficacy of GK01 autologous tumor-reactive T cells (TRT) in the treatment of patients with advanced solid tumors based on RECIST 1.1 criteria **Measure:** initial efficacy **Time Frame:** From enrollment to the end of treatment at 28 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participants who meet all of the following criteria are eligible for admission to the study: 1. 18≤ age ≤75 years old, male or female; 2. Patients with incurable advanced gastric cancer, esophageal cancer, cervical cancer, triple-negative breast cancer, non-small cell lung cancer, and other malignancies who have failed standard treatment (standard treatment failure is defined as those treated according to the 2022 CSCO Guidelines and whose tumor efficacy is assessed as disease progression (PD) or tumor recurrence or inability to tolerate existing treatment options); 3. There are tumor tissues or cancerous exudative thoracoabdominal fluid that can be used to isolate TRTs: the total volume of the solid tissue taken must be \&amp;amp;gt; 0.5cm3 or the weight must be \&amp;amp;gt;0.5g, the cancerous exudative thoracoabdominal fluid taken should contain at least 5×10\^8 total cells, and the lesions taken have not been treated with oncolytic virus. 4. There is at least one measurable lesion (according to RECIST1.1 criteria) even after TRTs sampling/puncture biopsy; 5. ECOG score 0-1; 6. The expected survival period is greater than 3 months; 7. Sufficient hematology and end-organ function, as defined by the following laboratory test results, should be completed within 14 days prior to TRTs tumor tissue collection: 1. Blood routine: white blood cell count ≥2.5×10\^9/L; Absolute neutrophil count (ANC) ≥1.5×10\^9/L; Absolute lymphocyte count (ALC) ≥1.0×10\^9/L; Platelet (PLT) ≥80×10\^9/L; Hemoglobin (HGB) ≥90g/L; 2. Coagulation function: International standardized ratio of prothrombin time (INR) ≤1.5×ULN; Partial prothrombin time (APTT) ≤1.5×ULN, unless anticoagulant therapy has been received within the previous 7 days; 3. Renal function: serum creatinine ≤1.5mg/dL (or 132.6μmol/L) or creatinine clearance ≥60mL/ min; 4. Liver function: aspartate aminotransferase (AST/SGOT) ≤3×ULN; Alanine transaminase (ALT/SGPT) ≤3×ULN; Total bilirubin (TBIL) ≤1.5×ULN; Note: In patients with liver metastasis or primary liver tumor, aspartate and alanine aminotransferase should be ≤5×ULN; For patients with a history of Gilbert syndrome or suspected Gilbert syndrome, total bilirubin (TBIL) should be ≤3×ULN; 5. Urine routine: urinary protein \&amp;amp;lt;2+, or 24-hour urinary protein quantity \&amp;amp;lt;1g; 6. Left ventricular ejection fraction (LVEF) ≥50% by echocardiography; 7. Pulmonary function tests with FEV1\&amp;amp;gt;60% or FEV1/FVC\&amp;amp;gt;0.7; 8. Blood oxygen saturation ≥ 93%. 8. Women of childbearing age who have a negative urine pregnancy test during screening and baseline and agree to use highly effective contraception for at least 1 year after the infusion; Male subjects whose partners are fertile must agree to use effective contraceptive methods and refrain from sperm donation for at least 1 year after the infusion; 9. No absolute or relative contraindications to surgery or puncture; 10. Any treatment for malignant tumors, including radiotherapy, chemotherapy, endocrine therapy, targeted therapy, tumor embolization, or Chinese medicine/herbal therapy with anti-tumor indications, must be discontinued 7 days before TRT sampling; 11. Sign a written informed consent (ICF) voluntarily, and have good compliance with the protocol requirements for visits or planned visits and other relevant research procedures. Exclusion Criteria: * Subjects who meet any of the following criteria will not be eligible to participate in this clinical trial: 1. Prior allergy to cyclophosphamide, fludarabine and interleukin-2 contraindications or to any component of the infusion product formulation or to other drugs to be used during the study (antibiotics, human serum albumin, dextran 40, etc.); 2. Any NCI CTCAE5.0 immune-related adverse reaction (irAE) grade \&amp;amp;gt;3 that has been permanently discontinued during any previous immunotherapy; 3. Patients with prior primary immunodeficiency and active autoimmune disease; 4. Previous history of organ allotransplantation, allogeneic stem cell transplantation and kidney replacement therapy; 5. Patients with current or past irreversible interstitial lung disease (except those caused by radiotherapy); 6. Combined with 2 or more malignant tumors; (Except for the following cases: malignant tumors that have been cured, such as non-melanoma skin cancer and in situ cervical cancer, bladder cancer, breast cancer, thyroid cancer, etc. that have survived more than 5 years without disease.) 7. Uncontrolled co-morbidity includes, but is not limited to, uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg) even after standard treatment, or any unstable cardiovascular and cerebrovascular disease, including transient ischemic attack, cerebrovascular accident, myocardial infarction, and unstable angina pectoral, that has occurred in the 6 months prior to treatment induction; Congestive heart failure rated III or IV by the New York Heart Association (NYHA); Ejection fraction \&amp;amp;lt; 50%; Severe heart rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, degree II-III atrioventricular block, etc. Electrocardiogram results show clinically significant abnormalities, or QTcF≥450ms (if the first examination is abnormal, the interval of at least 5 minutes, retest twice, using the comprehensive result/average value to judge eligibility); 8. Patients with esophageal or gastric varices that require immediate intervention (such as ligation or sclerotherapy) or are considered by the investigator or gastroenterologist or hepatologist to be at high risk of bleeding, have evidence of portal hypertension (including splenomegalysis on imaging), or have a history of varicose bleeding must undergo endoscopic evaluation within 3 months prior to enrollment; 9. Uncontrolled metabolic disorders, such as in patients with diabetes, or other non-malignant organ or systemic disease or cancer secondary reactions that can lead to higher medical risk and/or uncertainty in the evaluation of survival; 10. Hepatic encephalopathy, hepatorenal syndrome or Child-Pugh grade C or more severe cirrhosis, liver failure; 11. Clinically uncontrollable third space effusion, such as pleural fluid and ascites that could not be controlled by drainage or other methods before enrollment; 12. Combined with other serious organic disease or mental illness; 13. Patients with central nervous system metastasis; 14. Uncontrolled systemic active infection; 15. Receive vaccination within 2 months before signing the informed consent, or plan to receive vaccination during the study; 16. Currently or within 30 days before signing the informed consent to participate in clinical trials of other drugs or biotherapeutics, except cell therapy that has been fully metabolized; 17. have used within 4 weeks prior to the treatment, or have concomitant disease or active autoimmune disease that the investigator determined required the use of glucocorticoids or other immunosuppressive drugs during the trial period, excluding local percutaneous absorption of glucocorticoids (i.e., no more than 5 mg/ day of prednisone or equivalent doses of other glucocorticoids); 18. Surgical treatment, interventional therapy, radiotherapy, chemotherapy and immunotherapy for the studied disease were performed within 2 weeks before the treatment; 19. HIV positive, serological test positive for syphilis, or clinically active hepatitis B or C, including carriers of the virus (for hepatitis B, HBsAg positive persons should be excluded; For hepatitis C, HCVAB-positive patients need to be excluded); 20. Women who are breastfeeding during pregnancy or lactation; 21. Poor compliance due to physiological, family, social, geographical and other factors, unable to cooperate with the study protocol and follow-up plan; 22. Other conditions deemed unsuitable for participation in this experiment by the researcher. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** GK01 cell transfusions were performed in 10 patients with advanced solid tumors, including but not limited to advanced non-small cell lung cancer, gastric cancer, and esophageal cancer. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yi Zhang, Doctor **Phone:** 86+15138928971 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Ge Zhang **Phone:** 0086+13633861412 **Role:** CONTACT #### Locations **Location 1:** **City:** Zhengzhou **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yi Zhang, Doctor - **Phone:** 626-491-5096 - **Role:** CONTACT **Country:** China **Facility:** First Affiliated Hospital of Zhengzhou University **State:** Henan **Status:** RECRUITING **Zip:** 450052 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001943 - Term: Breast Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16064 - Name: Stomach Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5220 - Name: Breast Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8088 - Name: Esophageal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: LOW - As Found: Unknown - ID: M30373 - Name: Triple Negative Breast Neoplasms - Relevance: HIGH - As Found: Triple Negative Breast Cancer - ID: M5830 - Name: Uterine Cervical Neoplasms - 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: T5486 - Name: Stomach Cancer - Relevance: LOW - As Found: Unknown - ID: T2141 - Name: Esophageal Cancer - Relevance: HIGH - As Found: Esophageal Cancer ### Condition Browse Module - Meshes - ID: D000064726 - Term: Triple Negative Breast Neoplasms ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431087 **Acronym:** GIS **Brief Title:** Effect of a Mindfulnes Program "Healthy Under Stress" on Stress: A Prospective Intervention Study **Official Title:** Effect of a Mindfulnes Program "Healthy Under Stress" on Stress and Stress-associated Parameters: A Prospective Intervention Study #### Organization Study ID Info **ID:** S00822-NIM #### Organization **Class:** OTHER **Full Name:** University Hospital Tuebingen ### Status Module #### Completion Date **Date:** 2028-02-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-08-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-08 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Robert Bosch Hospital Stuttgart #### Lead Sponsor **Class:** OTHER **Name:** University Hospital Tuebingen #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Stress describes a state of worry and mental tension that results from an imbalance between demands and coping strategies, as well as the disruption of physiological homeostasis. It represents an important ability to adapt to environmental factors, and chronically has negative psychological and physical consequences. The mind-body medical program "Healthy in Stress" according to Esch aims to strengthen the individual's ability to deal with stress through comprehensive training. The main target parameter is stress reduction, measured using the Perceived Stress Scale (PSS). **Detailed Description:** After baseline (t0), all participant will receive the following intervention: The intervention lasts eight weeks, with a two-hour session held once a week. The selected topics include nutrition, mindfulness, exercise, relaxation techniques, dealing with stressors, effective communication and the promotion of a supportive social network. t1 (at the end of the program). t2 (3 months after t0). ### Conditions Module **Conditions:** - Subjective Stress **Keywords:** - Mindfulness - Healthy Lifestyle ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Single-Center, an Arm, prospective intervention study. ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will have two-hour sessions for 8 weeks. **Intervention Names:** - Other: Mindfulness course **Label:** Mindfulnes "Healthy Under Stress" Stress Management Program **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Mindfulnes "Healthy Under Stress" Stress Management Program **Description:** Online or in presence Information on Mindfulness, healthy diet and exercise. **Name:** Mindfulness course **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The Perceived Stress Scale (PSS-10) is a scale records patients' subjective stress in the last month in four subscales: worries, anxiety, happiness and needs). Ten items are rating on a five-point scale (1 = never, 5 = very often). **Measure:** Perceived Stress Scale **Time Frame:** After 8 Weeks (end of intervention) #### Secondary Outcomes **Description:** The Perceived Stress Scale (PSS-10) is a scale records patients' subjective stress in the last month in four subscales: worries, anxiety, happiness and needs). Ten items are rating on a five-point scale (1 = never, 5 = very often). **Measure:** Perceived Stress Scale **Time Frame:** Follow-up 3 Moths after the intervention **Description:** Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire on the severity of symptoms of anxiety and depressive disorders in the past week. The 14 items (seven on depression and seven on anxiety) are rated on a four-point scale. Each question is scored between zero (no impairment) and four (severe impairment). **Measure:** Hospital Anxiety and Depression Scale **Time Frame:** After 8 Weeks (end of intervention) **Description:** Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire on the severity of symptoms of anxiety and depressive disorders in the past week. The 14 items (seven on depression and seven on anxiety) are rated on a four-point scale. Each question is scored between zero (no impairment) and four (severe impairment). **Measure:** Hospital Anxiety and Depression Scale **Time Frame:** Follow-up 3 Moths after the intervention **Description:** Quality of life Questionnaire (SF-36) includes one multi-item scale that assesses eight health concepts: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Scores range from 0 - 100 (Lower scores = more disability, higher scores = less disability). **Measure:** Quality of life Questionnaire **Time Frame:** After 8 Weeks (end of intervention) **Description:** Quality of life Questionnaire (SF-36) includes one multi-item scale that assesses eight health concepts: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Scores range from 0 - 100 (Lower scores = more disability, higher scores = less disability). **Measure:** Quality of life Questionnaire **Time Frame:** Follow-up 3 Moths after the intervention **Description:** The International Physical Activity Questionnaire (IPAQ) records physical activity over the past seven days using 8 questions. The duration of activities of moderate and high exertion as well as the duration of sitting are asked, and the result is indicated using the metabolic equivalent (MET). **Measure:** International Physical Activity Questionnaire **Time Frame:** After 8 Weeks (end of intervention) **Description:** The International Physical Activity Questionnaire (IPAQ) records physical activity over the past seven days using 8 questions. The duration of activities of moderate and high exertion as well as the duration of sitting are asked, and the result is indicated using the metabolic equivalent (MET). **Measure:** International Physical Activity Questionnaire **Time Frame:** Follow-up 3 Moths after the intervention **Description:** The Mediterranean Diet Adhrence Screener (MEDAS) is a questionnaire to assess adherence to the Mediterranean diet (DM). It consists of 14 items on eating habits, each of which is rated with one or zero points. The higher the score, the better the adherence to the MD. **Measure:** Mediterranean Diet Adhrence Screener **Time Frame:** After 8 Weeks (end of intervention) **Description:** The Mediterranean Diet Adhrence Screener (MEDAS) is a questionnaire to assess adherence to the Mediterranean diet (DM). It consists of 14 items on eating habits, each of which is rated with one or zero points. The higher the score, the better the adherence to the MD. **Measure:** Mediterranean Diet Adhrence Screener **Time Frame:** Follow-up 3 Moths after the intervention **Description:** The Mindful Attention and Awareness Scale (MAAS) is a questionnaire of 15 items on a six-point scale (1 = almost always, 6 = almost never) to measure the frequency of actual experiences. **Measure:** Mindful Attention and Awareness Scale **Time Frame:** After 8 Weeks (end of intervention) **Description:** The Mindful Attention and Awareness Scale (MAAS) is a questionnaire of 15 items on a six-point scale (1 = almost always, 6 = almost never) to measure the frequency of actual experiences. **Measure:** Mindful Attention and Awareness Scale **Time Frame:** Follow-up 3 Moths after the intervention **Description:** In order to evaluate the safety of the intervention, unforeseen events are documented. For this purpose participants are explicitly asked about the occurrence of these. **Measure:** Safety evaluation **Time Frame:** After 8 Weeks (end of intervention) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Employees, patients and family members of the Robert-Bosch-Krankenhaus (RBK) and Bosch Health Campus of all specialties. * Informed consent. Exclusion Criteria: * Physical or mental condition which, in the opinion of the investigator does not allow the patient to participate in the study. * Participation in other clinical studies with behavioral, psychological or complementary medical interventions. * Insufficient knowledge of the German language. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Marcela Winkler, Dr **Phone:** +49711 8181 **Phone Ext:** 2073 **Role:** CONTACT #### Locations **Location 1:** **City:** Stuttgart **Country:** Germany **Facility:** Robert-Bosch-Krankenhaus **State:** Baden Würtenberg **Zip:** 70341 #### Overall Officials **Official 1:** **Affiliation:** Robert Bosch Gesellschaft für Medizinische Forschung mbH **Name:** Marcela Winkler, Dr **Role:** STUDY_DIRECTOR ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431074 **Brief Title:** Radicle Calm 24: A Study of Health and Wellness Products on Feelings of Anxiety and Related Health Outcomes **Official Title:** Radicle Calm™ 24: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Feelings of Anxiety and Related Health Outcomes #### Organization Study ID Info **ID:** RADX-P-2402 #### Organization **Class:** INDUSTRY **Full Name:** Radicle Science ### Status Module #### Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-30 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Radicle Science #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on feelings of anxiety and related health outcomes **Detailed Description:** This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants will (1) endorse a desire for less feelings of anxiety (2) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study. Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded. Self-reported data are collected electronically from eligible participants over 7 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study. ### Conditions Module **Conditions:** - Anxiety - Stress ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Participants will be stratified based on gender at birth, then randomized to one of the study arms ##### Masking Info **Masking:** DOUBLE **Masking Description:** The investigator is blinded to the participants' study product assignment. Participants are blinded to the study product they are assigned. **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Calm Product Form 1 - control **Intervention Names:** - Dietary Supplement: Placebo Control Form 1 **Label:** Placebo Control 1 **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** Calm Product Form 1 - active product 1 **Intervention Names:** - Dietary Supplement: Calm Active Study Product 1.1 Usage **Label:** Active Product 1.1 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Placebo Control 1 **Description:** Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks. **Name:** Placebo Control Form 1 **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Active Product 1.1 **Description:** Participants will use their Radicle Calm Active Study Product 1.1 as directed for a period of 6 weeks. **Name:** Calm Active Study Product 1.1 Usage **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Other Outcomes **Description:** Mean difference in saliva concentration as assessed by saliva-based IgG (Immunoglobulin) biomarker. (Optional; among consented participants only). **Measure:** Change in saliva concentration of at-home (direct-to-consumer) specimen assay (1) **Time Frame:** 6 weeks **Description:** Mean difference in saliva concentration as assessed by saliva-based cytokines (Interleukin 1 beta, Interleukin 8, Tumor necrosis factor-alpha, and Interleukin 6) biomarker. (Optional; among consented participants only). **Measure:** Change in saliva concentration of at-home (direct-to-consumer) specimen assay (2) **Time Frame:** 6 weeks **Description:** Mean difference in saliva concentration as assessed by saliva-based dehydroepiandrosterone sulfate (DHEA-S) biomarker. (Optional; among consented participants only). **Measure:** Change in saliva concentration of at-home (direct-to-consumer) specimen assay (3) **Time Frame:** 6 weeks **Description:** Mean difference in saliva concentration as assessed by saliva-based estradiol biomarker. (Optional; among consented participants only). **Measure:** Change in saliva concentration of at-home (direct-to-consumer) specimen assay (4) **Time Frame:** 6 weeks **Description:** Mean difference in saliva concentration as assessed by saliva-based progesterone biomarker. (Optional; among consented participants only). **Measure:** Change in saliva concentration of at-home (direct-to-consumer) specimen assay (5) **Time Frame:** 6 weeks **Description:** Mean difference in saliva concentration as assessed by saliva-based testosterone biomarker. (Optional; among consented participants only). **Measure:** Change in saliva concentration of at-home (direct-to-consumer) specimen assay (6) **Time Frame:** 6 weeks **Description:** Mean difference in saliva concentration as assessed by saliva-based cortisol biomarker. (Optional; among consented participants only). **Measure:** Change in saliva concentration of at-home (direct-to-consumer) specimen assay (7) **Time Frame:** 6 weeks **Description:** Mean difference in saliva concentration as assessed by saliva-based melatonin biomarker. (Optional; among consented participants only). **Measure:** Change in saliva concentration of at-home (direct-to-consumer) specimen assay (8) **Time Frame:** 6 weeks **Description:** Mean difference in saliva concentration as assessed by saliva-based C-Reactive Protein (CRP) biomarker. (Optional; among consented participants only). **Measure:** Change in saliva concentration of at-home (direct-to-consumer) specimen assay (9) **Time Frame:** 6 weeks **Description:** Mean difference in blood concentration as assessed by blood-based cortisol biomarker (1 drop). (Optional; among consented participants only). **Measure:** Change in blood concentration of at-home (direct-to-consumer) specimen assay (1) **Time Frame:** 6 weeks **Description:** Mean difference in blood concentration as assessed by blood-based homocysteine biomarker (1 drop). (Optional; among consented participants only). **Measure:** Change in blood concentration of at-home (direct-to-consumer) specimen assay (2) **Time Frame:** 6 weeks **Description:** Mean difference in blood concentration as assessed by blood-based ferritin biomarker (1 drop). (Optional; among consented participants only). **Measure:** Change in blood concentration of at-home (direct-to-consumer) specimen assay (3) **Time Frame:** 6 weeks **Description:** Mean difference in blood concentration as assessed by blood-based thyroid stimulating hormone (TSH) biomarker (1 drop). (Optional; among consented participants only). **Measure:** Change in blood concentration of at-home (direct-to-consumer) specimen assay (4) **Time Frame:** 6 weeks **Description:** Mean difference in blood concentration as assessed by blood-based hemoglobin A1C (HbA1c) biomarker (1 drop). (Optional; among consented participants only). **Measure:** Change in blood concentration of at-home (direct-to-consumer) specimen assay (5) **Time Frame:** 6 weeks **Description:** Mean difference in blood concentration as assessed by blood-based insulin biomarker (1 drop). (Optional; among consented participants only). **Measure:** Change in blood concentration of at-home (direct-to-consumer) specimen assay (6) **Time Frame:** 6 weeks **Description:** Mean difference in blood concentration as assessed by blood-based vitamin D biomarker (1 drop). (Optional; among consented participants only). **Measure:** Change in blood concentration of at-home (direct-to-consumer) specimen assay (7) **Time Frame:** 6 weeks **Description:** Mean difference in blood concentration as assessed by blood-based dehydroepiandrosterone sulfate (DHEA-S) biomarker (1 drop). (Optional; among consented male participants only). **Measure:** Change in blood concentration of at-home (direct-to-consumer) specimen assay (8) **Time Frame:** 6 weeks **Description:** Mean difference in blood concentration as assessed by blood-based testosterone biomarker (1 drop) (Optional; among consented male participants only). **Measure:** Change in blood concentration of at-home (direct-to-consumer) specimen assay (9) **Time Frame:** 6 weeks **Description:** Mean difference in blood concentration as assessed by blood-based estradiol biomarker (1 drop). (Optional; among consented participants only). **Measure:** Change in blood concentration of at-home (direct-to-consumer) specimen assay (10) **Time Frame:** 6 weeks **Description:** Mean difference in blood concentration as assessed by blood-based follicle-stimulating hormone (FSH) biomarker (1 drop). (Optional; among consented female participants only). **Measure:** Change in blood concentration of at-home (direct-to-consumer) specimen assay (11) **Time Frame:** 6 weeks **Description:** Mean difference in blood concentration as assessed by blood-based total cholesterol (high-density lipoproteins (HDL) and low-density lipoproteins (LDL)) biomarker (1 drop). (Optional; among consented participants only). **Measure:** Change in blood concentration of at-home (direct-to-consumer) specimen assay (12) **Time Frame:** 6 weeks **Description:** Mean difference in blood concentration as assessed by blood-based triglycerides (apolipoprotein A1 (ApoA1) and apolipoprotein B (ApoB)) (1 drop). (Optional; among consented participants only). **Measure:** Change in blood concentration of at-home (direct-to-consumer) specimen assay (13) **Time Frame:** 6 weeks **Description:** Mean difference in stool concentration as assessed by a stool sample (microbial diversity) (Optional; among consented participants only). **Measure:** Change in stool concentration of at-home (direct-to-consumer) specimen assay **Time Frame:** 6 weeks #### Primary Outcomes **Description:** Mean difference in feelings of anxiety score as assessed by Patient Reported Outcome Measurement System (PROMIS) Anxiety 8A (scale 8-40; where lower scores correspond to less feelings of anxiety) **Measure:** Change in feelings of anxiety **Time Frame:** 6 weeks #### Secondary Outcomes **Description:** Mean difference in stress score as assessed by Perceived Stress Scale 4 (PSS-4) (scale 0-16; where lower scores correspond to less stress) **Measure:** Change in stress **Time Frame:** 6 weeks **Description:** Mean difference in sleep score as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance 4A (scale 4-20; where lower scores correspond to better sleep quality/less sleep disturbance) **Measure:** Change in sleep **Time Frame:** 6 weeks **Description:** Mean difference in mood score as assessed by Patient Reported Outcome Measurement System (PROMIS) Emotional Distress-Depression 4A (scale 4-20; where lower scores correspond to lower levels of emotional distress) **Measure:** Change in mood (emotional distress) **Time Frame:** 6 weeks **Description:** Likelihood of achieving a MCID in sleep disturbance, as measured by Patient Reported Outcome Measurement System (PROMIS) Anxiety 8A (scale 8-40; where lower scores correspond to less feelings of anxiety) **Measure:** Minimal clinically important difference (MCID) in feelings of anxiety **Time Frame:** 6 weeks **Description:** Likelihood of experiencing minimal clinically important difference in stress score as assessed by Perceived Stress Scale 4 (PSS-4) (scale 0-16; where lower scores correspond to less stress) **Measure:** Minimal clinically important difference (MCID) in stress **Time Frame:** 6 weeks **Description:** Likelihood of experiencing minimal clinically important difference in sleep score as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance 4A (scale 4-20; where lower scores correspond to better sleep quality/less sleep disturbance) **Measure:** Minimal clinically important difference (MCID) in sleep **Time Frame:** 6 weeks **Description:** Likelihood of experiencing minimal clinically important difference in mood score as assessed by Patient Reported Outcome Measurement System (PROMIS) Emotional Distress-Depression 4A (scale 4-20; where lower scores correspond to lower levels of emotional distress) **Measure:** Minimal clinically important difference (MCID) in mood (emotional distress) **Time Frame:** 6 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults, at least 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities. Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed * Resides in the United States * Endorses less anxiety as a primary desire * Has the opportunity for at least 20% improvement in their primary health outcome * Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study Exclusion Criteria: * Reports being pregnant, trying to become pregnant, or breastfeeding * Unable to provide a valid US shipping address and mobile phone number * Reports current enrollment in another clinical trial * Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day) * Unable to read and understand English * Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk. * Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients. NYHA (New York Heart Association) Class Ill or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure * Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients. Anticoagulants, antihypertensive, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOls (monoamine oxidase inhibitors), or thyroid products * Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) * Lack of reliable daily access to the internet **Healthy Volunteers:** True **Maximum Age:** 105 Years **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Study Manager **Phone:** 760-281-3898 **Role:** CONTACT #### Locations **Location 1:** **City:** Del Mar **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Study Management - **Phone:** 760-281-3898 - **Role:** CONTACT **Country:** United States **Facility:** Radicle Science, Inc **State:** California **Status:** RECRUITING **Zip:** 92014 #### Overall Officials **Official 1:** **Affiliation:** Radicle Science, Inc **Name:** Emily K. Pauli, PharmD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Data will not be shared with researchers outside of Radicle Collaborators on this study. **IPD Sharing:** NO ### References Module #### See Also Links **Label:** Radicle Science, Inc **URL:** http://radiclescience.com ## Derived Section ### Condition Browse Module - Ancestors - 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: M4324 - Name: Anxiety Disorders - Relevance: HIGH - As Found: Anxiety - 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: D000001008 - Term: Anxiety Disorders ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431061 **Brief Title:** Clinical Evaluation of Proclear Toric and Biofinity Toric **Official Title:** Clinical Evaluation of Proclear Toric and Biofinity Toric #### Organization Study ID Info **ID:** EX-MKTG-158 #### Organization **Class:** INDUSTRY **Full Name:** Coopervision, Inc. ### Status Module #### Completion Date **Date:** 2024-08-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-08-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Coopervision, Inc. #### Responsible Party **Type:** SPONSOR ### 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 aim of this study is to compare the short-term clinical performance of two Toric contact lenses. **Detailed Description:** The aim of the study is to evaluate and compare the performance of two soft toric contact lenses in existing soft toric lens wearers in a short term (15 minutes wear) study. ### Conditions Module **Conditions:** - Astigmatism ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** SINGLE **Masking Description:** Single **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All participants will wear lens A for 15 minutes (Period 1). **Intervention Names:** - Device: Lens A (omafilcon B) **Label:** Lens A (omafilcon B) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** All participants will wear lens B for 15 minutes (Period 2). **Intervention Names:** - Device: Lens B (comfilcon A) **Label:** Lens B (comfilcon A) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Lens A (omafilcon B) **Description:** 15 minutes of daily wear. **Name:** Lens A (omafilcon B) **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Lens B (comfilcon A) **Description:** 15 minutes of daily wear. **Name:** Lens B (comfilcon A) **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Overall fit acceptance will be measured on scale of (0-4) where (0=Should not be worn and 4=Perfect) **Measure:** Overall fit acceptance **Time Frame:** 15 Minutes ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Are at least 17 years of age and has full legal capacity to volunteer. 2. Have understood and signed an information consent letter. 3. Are willing and able to follow instructions and maintain the appointment schedule. 4. Are an adapted soft toric contact lens wearer. 5. Do not habitually wear either of the two study lens types. 6. Have a vertex-corrected contact lens prescription with a spherical component of +4.00D to -9.00D in combination with astigmatism of no less than -0.75D and no more than -2.25D in each eye. 7. Can achieve best corrected distance visual acuity of +0.10 logMAR (subjective refraction) or better in each eye. 8. Can be fitted with and achieve a distance visual acuity of +0.18 logMAR or better in each eye with the study contact lenses. Exclusion Criteria: 1. Are participating in any concurrent clinical or research study. 2. Have any known active ocular disease and/or infection or slit lamp findings that would contraindicate contact lens use. 3. Have a systemic condition that in the opinion of the investigator may affect a study outcome variable. 4. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable. 5. Have known sensitivity to the diagnostic pharmaceuticals to be used in the study. 6. Have a history of not achieving comfortable CL use (5 days per week; \> 8 hours/day) 7. Are an employee of the Centre for Ocular Research \& Education directly involved in the study (i.e. on the delegation log). **Minimum Age:** 17 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Waterloo **Country:** Canada **Facility:** University of Waterloo #### Overall Officials **Official 1:** **Affiliation:** Centre for Ocular Research and Education **Name:** Lyndon Jones **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012030 - Term: Refractive Errors - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4558 - Name: Astigmatism - Relevance: HIGH - As Found: Astigmatism - ID: M14872 - Name: Refractive Errors - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001251 - Term: Astigmatism ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431048 **Brief Title:** No DIET Trial: Dogmatic Interruption of Enteral nuTrition **Official Title:** No DIET Trial: Dogmatic Interruption of Enteral nuTrition #### Organization Study ID Info **ID:** 2101744 #### Organization **Class:** OTHER **Full Name:** University of Missouri-Columbia ### Status Module #### Completion Date **Date:** 2025-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **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:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Jeffrey Coughenour #### Responsible Party **Investigator Affiliation:** University of Missouri-Columbia **Investigator Full Name:** Jeffrey Coughenour **Investigator Title:** Associate Professor of Clinical Surgery **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** There is currently limited guidance on when to hold nutritional supplementation through for patients, who are receiving tube feeding, undergoing surgical procedures. This study aims to investigate which time would be the best to stop nutrition, if at all, before undergoing a surgical procedure. **Detailed Description:** The risk for malnutrition-associated complications is high for patients in the trauma- surgical-, and neurological intensive care units. Patients with persistent neurologic impairment often require nutritional supplementation through a variety of naso-enteral or surgical feeding tubes such as percutaneous endoscopic gastrostomy (PEG) tubes. In patients with a protected airway, enteral nutrition has been reported to continue during invasive surgical procedures. Nonetheless, University Hospital's current SOC for holding enteral nutrition prior to undergoing surgical procedures under anesthesia is 8 hours. However, the current American Society of Anesthesiologists (ASA) guidelines do not make provision for inpatients receiving supplemental enteral nutrition. Enteral nutrition contains protein, fat, and carbohydrates, mimicking what patients would consume with a solid food meal. Balancing the need of optimized nutrition in critically ill patients with an unprotected airway against the risk of aspiration during surgical procedures brings a need for clear guidance on when to hold enteral nutrition prior to undergoing a tracheostomy procedure. ### Conditions Module **Conditions:** - Gastrostomy - Tracheostomy **Keywords:** - Percutaneous Endoscopic Gastrostomy - Tracheostomy - Enteral feeding ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The five groups per arm in this study are: 1. Nutrition will not be stopped preoperatively, but in the operating room (OR) for scheduled procedure. 2. Nutrition will be stopped when the patient is called to the OR for scheduled procedure. 3. Nutrition will be stopped 4 hours before the scheduled procedure. 4. Nutrition will be stopped 6 hours before the scheduled procedure. 5. Nutrition will be stopped 8 hours before the scheduled procedure. ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Nutrition will not be stopped preoperatively, but in the operating room (OR) for scheduled procedure. - Other: Nutrition will be stopped when the patient is called to the OR for scheduled procedure. - Other: Nutrition will be stopped 4 hours before the scheduled procedure. - Other: Nutrition will be stopped 6 hours before the scheduled procedure. - Other: Nutrition will be stopped 8 hours before the scheduled procedure. **Label:** Patients receiving PEG nutrition, scheduled for tracheostomy placement. **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Other: Nutrition will not be stopped preoperatively, but in the operating room (OR) for scheduled procedure. - Other: Nutrition will be stopped when the patient is called to the OR for scheduled procedure. - Other: Nutrition will be stopped 4 hours before the scheduled procedure. - Other: Nutrition will be stopped 6 hours before the scheduled procedure. - Other: Nutrition will be stopped 8 hours before the scheduled procedure. **Label:** Patients receiving naso-enteral feeding, scheduled for PEG placement. **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients receiving PEG nutrition, scheduled for tracheostomy placement. - Patients receiving naso-enteral feeding, scheduled for PEG placement. **Description:** Nutrition will not be stopped preoperatively, but in the operating room (OR) for scheduled procedure. **Name:** Nutrition will not be stopped preoperatively, but in the operating room (OR) for scheduled procedure. **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Patients receiving PEG nutrition, scheduled for tracheostomy placement. - Patients receiving naso-enteral feeding, scheduled for PEG placement. **Description:** Nutrition will be stopped when the patient is called to the OR for scheduled procedure. **Name:** Nutrition will be stopped when the patient is called to the OR for scheduled procedure. **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Patients receiving PEG nutrition, scheduled for tracheostomy placement. - Patients receiving naso-enteral feeding, scheduled for PEG placement. **Description:** Nutrition will be stopped 4 hours before the scheduled procedure. **Name:** Nutrition will be stopped 4 hours before the scheduled procedure. **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - Patients receiving PEG nutrition, scheduled for tracheostomy placement. - Patients receiving naso-enteral feeding, scheduled for PEG placement. **Description:** Nutrition will be stopped 6 hours before the scheduled procedure. **Name:** Nutrition will be stopped 6 hours before the scheduled procedure. **Type:** OTHER #### Intervention 5 **Arm Group Labels:** - Patients receiving PEG nutrition, scheduled for tracheostomy placement. - Patients receiving naso-enteral feeding, scheduled for PEG placement. **Description:** Nutrition will be stopped 8 hours before the scheduled procedure. **Name:** Nutrition will be stopped 8 hours before the scheduled procedure. **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Measurement of stomach contents will be done with enteral feeding stopped at different time points prior to undergoing the surgical procedure. **Measure:** Measuring stomach contents in patients undergoing a tracheostomy and/or PEG placement. **Time Frame:** 0-8 hours ### Eligibility Module **Eligibility Criteria:** Inclusion criteria: * Patients aged \>18 years. * Patients who require a tracheostomy or PEG placement. Exclusion criteria: * Patients with gastric and/or bowel obstruction. * Patients unable to receive enteral nutrition. * Patients who are pregnant and/or breastfeeding. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Antoinette Burger, PhD **Phone:** 5738843740 **Role:** CONTACT #### Locations **Location 1:** **City:** Columbia **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Antoinette Burger, PhD - **Phone:** 573-884-3740 - **Role:** CONTACT ***Contact 2:*** - **Name:** Jeffrey Coughenour, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Patrick Ward, DO - **Role:** SUB_INVESTIGATOR **Country:** United States **Facility:** University of Missouri Hospital **State:** Missouri **Zip:** 65212 #### Overall Officials **Official 1:** **Affiliation:** University of Missouri-Columbia **Name:** Jeffrey Coughenour, MD **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:** NCT06431035 **Brief Title:** Caffeine & Bodybuilding Dehydration Ability **Official Title:** Effect of Caffeinated Chewing Gum on Dehydration Ability in Bodybuilding Athletes: a Crossover Trial #### Organization Study ID Info **ID:** 113-3 #### Organization **Class:** OTHER **Full Name:** National Taiwan Sport University ### Status Module #### Completion Date **Date:** 2024-07-31 **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:** 2024-07-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-08 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-04-08 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Chih-Hui Chiu #### Responsible Party **Investigator Affiliation:** National Taiwan Sport University **Investigator Full Name:** Chih-Hui Chiu **Investigator Title:** Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** 15-20 trained bodybuilding athletes were divided into caffeine gum trial (CAF) and placebo trial (PL) with a randomized, double-blind study design. The participants chewing either caffeine Gum (CAF trial, containing 5 mg/kg of caffeine) or placebo gum (PL) for 10 minutes. After rested for 15 minutes, Participants used the bicycle to adjust the pedal resistance and speed according to their own feelings until they were dehydrated to 2% of their original body weight. **Detailed Description:** The purpose of this study was to investigate the effect of caffeinated chewing gum on dehydration ability in bodybuilding athletes. Methods: 15-20 trained bodybuilding athletes were divided into caffeine gum trial (CAF) and placebo trial (PL) with a randomized, double-blind study design. The participants chewing either caffeine Gum (CAF trial, containing 5 mg/kg of caffeine) or placebo gum (PL) for 10 minutes. After rested for 15 minutes, Participants used the bicycle to adjust the pedal resistance and speed according to their own feelings until they were dehydrated to 2% of their original body weight. Record time from exercise to completion of dehydration, heart rate, HRV, energy expenditure, fat oxidation rate and carbohydrate oxidation rate. ### Conditions Module **Conditions:** - Caffeine - Placebo ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** The participants were divided into caffeine gum trial (CAF) and placebo trial (PL) with a randomized, double-blind study design. ##### Masking Info **Masking:** SINGLE **Masking Description:** Using placebo chewing gum **Who Masked:** - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Chewing caffeine Gum (CAF trial, containing 5 mg/kg of caffeine) for 10 minutes before test. **Intervention Names:** - Dietary Supplement: caffeine **Label:** caffeine gum **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Chewing placebo gum (without caffeine) for 10 minutes before test. **Intervention Names:** - Dietary Supplement: caffeine **Label:** placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - caffeine gum - placebo **Description:** The participants chewed either caffeine gum (5 mg/kg for 10 minutes per chew) or a placebo (10 minutes per chew, using regular gum). **Name:** caffeine **Other Names:** - plocabo gum **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** The participants start dehydration until dehydrated to 2% of their original body weight. **Measure:** dehydration speed **Time Frame:** 15 minutes after intervention #### Secondary Outcomes **Description:** The energy expenditure during dehydration **Measure:** energy expenditure **Time Frame:** 15 minutes after intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * having won the top 8 places in a national competition, * having no cardiovascular or joint diseases * being an adult male Exclusion Criteria: * no top 8 finishes at national level * cardiovascular or joint disease, or any other condition that could be impaired by exercise * female and underage participants * previous caffeine allergy **Healthy Volunteers:** True **Maximum Age:** 40 Years **Minimum Age:** 20 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** ChihHui Chiu, PhD **Phone:** +886-4-22213108 **Phone Ext:** 3486 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Che-Hsiu Chen, PhD **Phone:** +886-4-22213108 **Phone Ext:** 3108 **Role:** CONTACT #### Locations **Location 1:** **City:** Taichung **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** ChihHui Chiu, PhD - **Role:** CONTACT **Country:** Taiwan **Facility:** National Taiwan University of Sport **Status:** RECRUITING **Zip:** 404 #### Overall Officials **Official 1:** **Affiliation:** National Taiwan University of Sport **Name:** ChihHui Chiu, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Only participant number and experimental data are provided. **IPD Sharing:** NO ## Document Section ### Large Document Module #### Large Docs - Date: 2024-05-23 - Filename: Prot_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: False - Label: Study Protocol - Size: 488910 - Type Abbrev: Prot - Upload Date: 2024-05-24T06:10 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014883 - Term: Water-Electrolyte Imbalance - ID: D000008659 - Term: Metabolic Diseases - ID: D000010335 - Term: Pathologic Processes ### 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: M6883 - Name: Dehydration - Relevance: HIGH - As Found: Dehydration - ID: M17624 - Name: Water-Electrolyte Imbalance - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003681 - Term: Dehydration ### Intervention Browse Module - Ancestors - ID: D000000697 - Term: Central Nervous System Stimulants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000010726 - Term: Phosphodiesterase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000058915 - Term: Purinergic P1 Receptor Antagonists - ID: D000058914 - Term: Purinergic Antagonists - ID: D000058905 - Term: Purinergic Agents - ID: D000018377 - Term: Neurotransmitter Agents ### Intervention Browse Module - Browse Branches - Abbrev: CNSSti - Name: Central Nervous System Stimulants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M5373 - Name: Caffeine - Relevance: HIGH - As Found: Continued - ID: M4029 - Name: Central Nervous System Stimulants - Relevance: LOW - As Found: Unknown - ID: M13629 - Name: Phosphodiesterase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: T370 - Name: Caffeine - Relevance: HIGH - As Found: Continued ### Intervention Browse Module - Meshes - ID: D000002110 - Term: Caffeine ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431022 **Acronym:** webSTAIR **Brief Title:** Web-administered STAIR for Patients on Behavioral Health Waitlists **Official Title:** The Feasibility, Acceptability, and Initial Effectiveness of Web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR) for Posttraumatic Stress Disorder (PTSD) Administered to Patients on Behavioral Health Waitlists #### Organization Study ID Info **ID:** H-44467 #### Organization **Class:** OTHER **Full Name:** Boston Medical Center ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **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:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Boston 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:** Posttraumatic stress disorder (PTSD) is a significant public health challenge with population prevalence rates in the US between 6.1 to 9.2%. There are large racial and socioeconomic inequities in access to PTSD treatment, as up to half (30-50%) of patients in safety net clinical settings meet criteria for PTSD, yet only 13% receive any behavioral health treatment. Workforce shortages are one major barrier to accessing care. Additional barriers to care can include heightened mental health stigma and mistrust of health services. Digital mental health interventions (DMHIs) may be suitable within the continuum of care for PTSD in hospital settings, given their potential for rapid-access, scalability, and the high acceptability of DMHI among individuals with high stigma and social needs. Among the available DMHIs for PTSD, the investigators have selected web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR), based on emerging scientific evidence and a close collaboration with Boston Medinal Center (BMC) users (patients and providers) in a previous pilot study in primary care. The aim of this randomized study is to implement webSTAIR at BMC in the Recovery from Stress and Trauma through Outpatient Care, Research, and Education (RESTORE) Center's subspecialty clinic. ### Conditions Module **Conditions:** - Post Traumatic Stress Disorder **Keywords:** - Digital mental health intervention (DMHI) - Community health worker (CHW) - Web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR) - Stepped care ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### 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:** Participants on the Research, and Education Center (RESTORE) waitlist randomized to this arm will receive the self-managed web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR). **Intervention Names:** - Behavioral: webSTAIR **Label:** Self-directed webSTAIR **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants on the RESTORE waitlist randomized to this arm will receive the web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR) with coaching support from a CHW. **Intervention Names:** - Behavioral: webSTAIR - Behavioral: CHW coaching **Label:** webSTAIR with coaching from a Community Health Worker (CHW) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Self-directed webSTAIR - webSTAIR with coaching from a Community Health Worker (CHW) **Description:** WebSTAIR is a self-paced, brief skills-focused treatment for PTSD that focused on improving one's ability to manage emotions and relationships. **Name:** webSTAIR **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - webSTAIR with coaching from a Community Health Worker (CHW) **Description:** CHWs will provide webSTAIR coaching, which includes motivational, problem solving, and cognitive-behavioral strategies to enhance skills practice and engagement. **Name:** CHW coaching **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The recruitment rate will be calculated by dividing the number of participants by the total number of eligible participants. **Measure:** Feasibility based on recruitment rate **Time Frame:** 3 months **Description:** The proportion of assessments completed will be calculated by dividing the number of assessments completed by the total number of participants. **Measure:** Feasibility based on assessment completion rate **Time Frame:** 3 months, 6 months **Description:** The attendance rate will be calculated by dividing the number of webSTAIR sessions attended by the potential number of webSTAIR sessions for each participant. **Measure:** Feasibility based on attendance rate **Time Frame:** 3 months **Description:** Client satisfaction/acceptability will be measured by the Client Satisfaction Questionnaire (CSQ-8) which is an 8 item instrument with each item having 4 potential responses form 1 to 4. Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction. **Measure:** Client satisfaction **Time Frame:** 3 months, 6 months #### Secondary Outcomes **Description:** The PCL-5 is a 20-item self-report checklist of PTSD symptoms based on the DSM-5 criteria1. It measures the degree to which respondents have been bothered by each symptom over the past month or week. To score the PCL-5, a cut-off raw score of 38 is used for a provisional diagnosis of PTSD. Additionally, the DSM-5 diagnostic rule requires at least one symptom from cluster B (questions 1-5), one from cluster C (questions 6-7), two from cluster D (questions 8-14), and two from cluster E (questions 15-20). **Measure:** PTSD Checklist for DSM-5 (PCL-5) **Time Frame:** baseline, 3 months, 6 months **Description:** The Trauma Symptoms of Discrimination Scale (TSDS) is a 21 item self-report measure designed to assess the traumatizing impact of discrimination broadly by measuring anxiety-related symptoms of trauma due to discriminatory experiences. Participants report the frequency of their experience of discriminatory distress regarding trauma on a 4-point scale ranging from 0 (Never) to 3 (Often). Scores can range from 0 to 63 and higher scores are associated with more trauma symptoms of discrimination. **Measure:** Trauma Symptoms of Discrimination (TSDS) **Time Frame:** baseline, 3 months, 6 months **Description:** The WSAS is scored using a 9-point Likert-type scale ranging from 0 (no impairment) to 8 (severe impairment). Potential scores range from 0 to 40 with higher scores indicating higher levels of impairment in the assessed areas of a respondent's life. **Measure:** Work and Social Functioning (WSAS) **Time Frame:** baseline, 3 months, 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Client on the RESTORE Center waitlist at Boston Medical Center * Over 18 years of age * Able to receive therapy in English or Spanish (per participant report) * Exposure to trauma (as indicated by the Life Events Checklist for the DSM-5 \[LEC-5\]) * Probable PTSD (as indicated by the PTSD Checklist for the DSM-5 \[PCL-5\] based on PCL score of 33+). * Reasonable to access to technology (e.g., phone, computer, internet access). Exclusion Criteria: * Patient declines to be in the study. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Sarah Valentine, PhD **Phone:** (617) 414-1989 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Nuha Alshabani, PhD **Phone:** (617) 414-1989 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Boston Medical Center, Psychiatry Department **Name:** Sarah Valentine, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000068099 - Term: Trauma and Stressor Related Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M16103 - Name: Stress Disorders, Post-Traumatic - Relevance: HIGH - As Found: Post Traumatic Stress Disorder - ID: M24916 - Name: Stress Disorders, Traumatic - Relevance: HIGH - As Found: Stress Disorder - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M222 - Name: Trauma and Stressor Related 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: D000040921 - Term: Stress Disorders, Traumatic - ID: D000013313 - Term: Stress Disorders, Post-Traumatic ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06431009 **Acronym:** RMS **Brief Title:** The Danish Region Midt Schizophrenia Cohort **Official Title:** The Danish Region Midt Schizophrenia (RMS) Cohort: Representative Cohort of Patients With a First-episode Schizophrenia Spectrum Disorder With Long-term Follow-up #### Organization Study ID Info **ID:** 2024-001 #### Organization **Class:** OTHER **Full Name:** University of Aarhus ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-20 **Type:** ACTUAL **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-02-23 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Aarhus University Hospital #### Lead Sponsor **Class:** OTHER **Name:** University of Aarhus #### 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 objective of this study is to recruit patients at the first diagnosis with a schizophrenia spectrum disorder (SSD) and ultra-high risk patients (UHR), defined as patients with drug abuse and psychotic symptoms indicating a risk for developing schizophrenia. Thereby, the investigators aim to establish a large representative cohort of patients with a first-episode SSD or patients at UHR, enabling investigations of the etiology and long-term prognosis of SSDs. The primary aim is to learn more about the importance of adverse childhood experiences (ACEs) and the immune system in the etiology and course of schizophrenia. Patients will be followed with planned visits after 1, 2, 3, 12 and 24 months including online questionnaires after 2, 6, 10 and 26 weeks. There will be the possibility to contact patients again for subsequent follow-up visits. **Detailed Description:** Study design: Cohort study with pre-defined longitudinal follow-up visits. Patients: Patients with a SSD (ICD-10: F20-29) or patients at UHR (ICD: 1\*.5) aged ≥15 years. Sample size: Within the Central Denmark Region (CDR), approximately 700 patients are each year diagnosed with a SSD and 100 with UHR. The investigators will establish recruitment at all psychiatric hospitals in the CDR between January 2024 until June 2025. Our aim is to establish continued recruitment of 100-150 patients/year. Hence, the investigators expect to recruit 300-350 patients during the period 2024-2026. Procedures: Patients will be included within three months of the first SSD or UHR diagnosis at one of the psychiatric hospitals in the CDR. Before inclusion, an interview with the Schedules for Clinical Assessment in Neuropsychiatry (SCAN) interview will validate the diagnosis. At baseline and follow-up visits (details in the full protocol and Table 1), patients will be rated by use of the 6-item Positive and Negative Syndrome Scale (PANSS-6), the Clinical Global Impression Severity Scale (CGI-S), the Global Assessment of Functioning Scale (GAF), the Schizophrenia Quality of Life Scale (SQLS), Alcohol Use Disorders Identification Test (AUDIT), Drug Use Disorders Identification Test (DUDIT), Fagerström Test for Nicotine Dependence (FTND), Major Depression Inventory (MDI), the Aarhus Side effect Assessment Questionnaire (ASAQ), the "Udvalg for Kliniske Undersøgelser" side effect scale (UKU), and the Calgary Depression Scale for Schizophrenia (CDSS). Furthermore, patients will fill out the self-reported WHO Adverse Childhood Experience International Questionnaire (ACE-IQ) and the Insomnia Severity Index (ISI), the Epsworth Sleepiness Scale (ESS), and the Pittsburgh Sleep Quality Index (PSQI) to measure sleep. The Matrics Consensus Cognitive Battery (MCCB), which consists of 10 cognitive tests, will measure cognition. To measure consciousness, patients will fill out the Perceived Stress Scale (PSS), Toronto Alexithymia Scale (TAS-20), and Metacognition Superiority illusion. During the first three months, participants will wear an actigraph to have a proxy measure of activity and sleep. Blood sampling will be performed at baseline and after 3, 12 and 24 months to measure markers of inflammation and to enable genetic and epigenetic analyses. Heart rate, blood pressure, height, body weight, waist and hip circumference will be recorded. Patients will be treated according to clinical indication, i.e., they will receive routine clinical care at the local psychiatric hospital and participation in this study will not affect the treatment. Patients can be included in this study independent of whether they are treated with psychotropic drugs or not. Follow-up: Patients will be treated and followed according to normal clinical treatment guidelines at the local psychiatric hospitals, which will not be affected by participation in the RMS cohort. Patients will have follow-up visits for the RMS study after 1, 2, 3, 12 and 24 months after the individual inclusion date and fill out online questionnaires after 2, 6, 10, and 26 weeks. Endpoints: The primary endpoint is the correlation between ACEs and inflammatory markers measured at baseline with the change on PANSS-6 from baseline to follow-up visits. Key secondary endpoints include changes in genetic, epigenetics, cognition, PSQI and ISI. Additional secondary endpoints include changes in ASAQ, UKU, SQLS, CDSS, GAF, CGI-S, body weight, hip and waist circumference, blood pressure, and heart rate. For patients enrolled in the study, all endpoints will initially be collected and several repeated during the study duration. Safety: Patients will follow treatment-as-usual at their local hospital, with the clinicians from the local hospital being responsible for safety monitoring according to local treatment guidelines. Blood sample results will be obtained from the patient's medical record (MidtEPJ) at the study visits to monitor biochemical safety parameters for medical treatment. Between follow-up visits for the RMS cohort, patients will follow guideline-based safety monitoring at the local psychiatric hospital. Study duration: Continuous. The investigators aim to establish continuous recruitment and that all patients with a first-episode SSD or UHR diagnosis fulfilling inclusion criteria will be offered participation in the RMS Cohort. ### Conditions Module **Conditions:** - Schizophrenia **Keywords:** - Schizophrenia - Antipsychotics - Adverse Childhood Experiences (ACE) - Immune system ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 350 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with a SSD (ICD-10: F20-29) aged ≥15 years. **Intervention Names:** - Other: Treatment-as-usual **Label:** Schizophrenia #### Arm Group 2 **Description:** Patients at UHR (ICD: 1\*.5) aged ≥15 years. **Intervention Names:** - Other: Treatment-as-usual **Label:** Ultra High Risk ### Interventions #### Intervention 1 **Arm Group Labels:** - Schizophrenia - Ultra High Risk **Description:** Patients will be treated and followed according to normal clinical treatment guidelines at the local psychiatric hospitals, which will not be affected by participation in the RMS cohort. **Name:** Treatment-as-usual **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The primary endpoint is the correlation between adverse childhood experiences (ACEs, from 0 to 13 ACEs measured via the World Health Organization (WHO) ACE-IQ), reported at baseline, with the change on the 6-item positive and negative symptom scale (PANSS-6, minimum score=0, maximum score=30), with higher PANSS-6 scores indicating greater symptom severity **Measure:** Adverse childhood experiences (ACEs) **Time Frame:** from baseline to follow-up visits after 52 and 104 weeks. #### Secondary Outcomes **Description:** Changes in cognition, measured via matrics consensus cognitive battery (MCCB, presenting T-scores (minimum=0, maximum=60) for 7 different cognitive domains) with higher scores indicating better cognitive functioning **Measure:** Cognition **Time Frame:** from baseline to follow-up visits after 52 and 104 weeks. **Description:** Changes in sleep quality (measured via Pittsburgh Sleep Quality Index (PSQI, minimum score=0, maximum score=39) and Insomnia Severity Index (ISI, minimum score=0, maximum score=28), with both measures indicating worse sleep quality depending on higher scores on the scales) **Measure:** Sleep **Time Frame:** from baseline to follow-up visits after 52 and 104 weeks. **Description:** Changes in quality-of-life (measuring psychosocial quality-of-life, energy+motivation, and symptoms+side effects via the Schizophrenia Quality of Life Scale (SQLS, minimum score=0, maximum score=30), with higher scores indicating worse quality-of-life) **Measure:** Quality-of-life **Time Frame:** from baseline to follow-up visits after 52 and 104 weeks. **Description:** Changes in level of functioning, (measured via the Global Assessment of Functioning (GAF), with higher scores on a scale from 0 to 100 indicating better functioning) **Measure:** Level of functioning **Time Frame:** from baseline to follow-up visits after 52 and 104 weeks. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age ≥15 years 2. Diagnosed within the previous 3 months with first-episode SSD (ICD-10: F20-29) or UHR (ICD-10: F1X.5) 3. Able to give informed oral and written consent. Exclusion Criteria: 1. Any coercive measure including patients in forensic psychiatry 2. In a clinical condition where the treating clinician evaluates that the patient is not able to attend the research study. **Minimum Age:** 15 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Any patient aged ≥15 years diagnosed with first-episode SSD or UHR diagnosis and without any coercive measure at the time of inclusion will be relevant for inclusion in the study. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ole Köhler-Forsberg, MD, PhD **Phone:** 0045 78471610 **Role:** CONTACT #### Locations **Location 1:** **City:** Aarhus **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ole Köhler-Forsberg - **Phone:** 0045 78471610 - **Role:** CONTACT **Country:** Denmark **Facility:** Aarhus University Hospital Psychiatry **Status:** RECRUITING **Location 2:** **City:** Herning **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ole Köhler-Forsberg - **Phone:** 0045 78471610 - **Role:** CONTACT **Country:** Denmark **Facility:** Psychiatric Hospital Gødstrup **Status:** RECRUITING **Location 3:** **City:** Horsens **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ole Köhler-Forsberg - **Phone:** 0045 78471610 - **Role:** CONTACT **Country:** Denmark **Facility:** Psychiatric Hospital Horsens **Status:** RECRUITING **Location 4:** **City:** Randers **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ole Köhler-Forsberg - **Phone:** 0045 78471610 - **Role:** CONTACT **Country:** Denmark **Facility:** Psychiatric Hospital Randers **Status:** RECRUITING **Location 5:** **City:** Silkeborg **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ole Köhler-Forsberg - **Phone:** 0045 78471610 - **Role:** CONTACT **Country:** Denmark **Facility:** Psychiatric Hospital Midt **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019967 - Term: Schizophrenia Spectrum and Other Psychotic 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: M15376 - Name: Schizophrenia - Relevance: HIGH - As Found: Schizophrenia - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M21838 - Name: Schizophrenia Spectrum and Other Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012559 - Term: Schizophrenia ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M11982 - Name: Morphine - Relevance: LOW - As Found: Unknown - ID: M16904 - Name: Antipsychotic Agents - Relevance: LOW - As Found: Unknown - ID: M15642 - Name: Silver Sulfadiazine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430996 **Brief Title:** Caffeinated Chewing Gum on 400-meter Performance **Official Title:** Effects of Caffeinated Chewing Gum on 400-meter Performance and Fatigue Index of Sprinters: a Crossover Trial #### Organization Study ID Info **ID:** 113-2 #### Organization **Class:** OTHER **Full Name:** National Taiwan Sport University ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2024-08-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-08 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-04-08 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Collaborators **Class:** FED **Name:** National Science and Technology Council #### Lead Sponsor **Class:** OTHER **Name:** Chih-Hui Chiu #### Responsible Party **Investigator Affiliation:** National Taiwan Sport University **Investigator Full Name:** Chih-Hui Chiu **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:** 20 trained sprinter were divided into caffeine Gum trial (CAF) and Placebo trial (PL) with a randomized, double-blind study design. The participants chewing either caffeine Gum (CAF trial, containing 3 mg/kg of caffeine) or Placebo Gum (PL) for 10 minutes. The outcomes are Running-Based Anaerobic Sprint Test and 400-meter sprint test was performed. **Detailed Description:** The purpose of this study was to investigate the effect of caffeinated chewing gum on 400-meter sprint performance. 20 trained sprinter were divided into caffeine Gum trial (CAF) and Placebo trial (PL) with a randomized, double-blind study design. The participants chewing either caffeine Gum (CAF trial, containing 3 mg/kg of caffeine) or Placebo Gum (PL) for 10 minutes. After rested for 15 minutes, the participants underwent a Running-Based Anaerobic Sprint Test. After a 30-minute break, a 400-meter sprint test was performed. The blood lactate concentration were collected before and after 400-meter sprint from finger. Saliva samples were predicted to be collected before chewing gum, before the RAST, and after a 400-meter sprint. Saliva samples will be analyzed for caffeine and α-amylase concentrations in saliva. ### Conditions Module **Conditions:** - Caffeine - Placebo **Keywords:** - exercise performance - fatigue index - α amylase ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** SINGLE **Who Masked:** - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The participants chewing caffeine gum 10 minutes before exercise **Intervention Names:** - Dietary Supplement: caffeine **Label:** caffeine gum **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The participants chewing placebo gum 10 minutes before exercise **Intervention Names:** - Dietary Supplement: caffeine **Label:** placebo gum **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - caffeine gum - placebo gum **Description:** The participants chewing either caffeine Gum (CAF trial, containing 3 mg/kg of caffeine) or Placebo Gum (PL) for 10 minutes. After rested for 15 minutes, the participants underwent tests. **Name:** caffeine **Other Names:** - plocabo gum **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Measure the fatigue index (%) **Measure:** Running-Based Anaerobic Sprint Test (RAST) **Time Frame:** 15 minutes after intervention **Description:** Measure the 400-meter completion time (seconds) **Measure:** 400-meter sprinting **Time Frame:** 30 minutes after RAST ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 6 years of professional short sprinting training * 6 months of ongoing training, and * 3 months of recovery from sports injuries such as strains and sprains. Exclusion Criteria: * Non-specialized sprinters. * has not trained regularly for the past 6 months. * has recovered from an athletic injury. * less than 3 months of recovery from a sports injury, or participants with epilepsy, hypertension, hyperlipidemia, heart disease, arthritis, osteoporosis, brain injury, or a history of caffeine allergy. **Healthy Volunteers:** True **Maximum Age:** 30 Years **Minimum Age:** 20 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Taichung **Country:** Taiwan **Facility:** National Taiwan University of Sport **Zip:** 404 #### Overall Officials **Official 1:** **Affiliation:** Sport Science Research Center **Name:** ChihHui Chiu, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Only participant number and relevant experimental data are provided. **IPD Sharing:** NO ## Document Section ### Large Document Module #### Large Docs - Date: 2024-05-23 - Filename: Prot_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: False - Label: Study Protocol - Size: 467644 - Type Abbrev: Prot - Upload Date: 2024-05-24T06:04 ## 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: M8364 - Name: Fatigue - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - ID: D000000697 - Term: Central Nervous System Stimulants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000010726 - Term: Phosphodiesterase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000058915 - Term: Purinergic P1 Receptor Antagonists - ID: D000058914 - Term: Purinergic Antagonists - ID: D000058905 - Term: Purinergic Agents - ID: D000018377 - Term: Neurotransmitter Agents ### Intervention Browse Module - Browse Branches - Abbrev: CNSSti - Name: Central Nervous System Stimulants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M5373 - Name: Caffeine - Relevance: HIGH - As Found: Continued - ID: M4029 - Name: Central Nervous System Stimulants - Relevance: LOW - As Found: Unknown - ID: M13629 - Name: Phosphodiesterase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: T370 - Name: Caffeine - Relevance: HIGH - As Found: Continued ### Intervention Browse Module - Meshes - ID: D000002110 - Term: Caffeine ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430983 **Brief Title:** Recurrent Liver Cancer: Reconceptualization and Reevaluation **Official Title:** Recurrent Liver Cancer: Reconceptualization and Reevaluation #### Organization Study ID Info **ID:** 2024KY16401 #### Organization **Class:** OTHER **Full Name:** Nanjing Medical University ### Status Module #### Completion Date **Date:** 2027-10-01 **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:** 2026-08-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Nanjing Medical University #### Responsible Party **Investigator Affiliation:** Nanjing Medical University **Investigator Full Name:** Yewei Zhang **Investigator Title:** Chief Physician **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this observational study is to determine if a specific protein can serve as a novel indicator for the recurrence of liver cancer. The study will focus on recurrent liver cancer patients and compare participants to primary liver cancer patients as controls. The primary purpose is to assess whether the elevated levels of this protein can be used to monitor the recurrence of liver cancer. The main questions it aims to answer are: Is the levels of the protein significantly elevated in recurrent liver cancer patients compared to primary liver cancer patients? Can the protein be used as a reliable biomarker for the early detection of liver cancer recurrence? Researchers will compare the protein levels in the following groups: 50 recurrent liver cancer patients (training set) with abnormally high levels of the protein. 250 recurrent liver cancer patients (validation set) to confirm the protein's elevation in a separate cohort. Participants will be required to: * Provide blood samples for protein analysis. * Undergo regular follow-up visits for monitoring and data collection. * Allow access to their medical records for relevant clinical information. **Detailed Description:** As part of the patient registry, investigators will implement the following registration procedures and other quality factors: Screening and Recruitment: Eligible patients will be screened and recruited through hospital liver cancer outpatient clinics and wards. Patients must meet the diagnostic criteria for recurrent or primary liver cancer and be willing to participate in the study. Data Collection: Clinical information of participants will be collected, including demographic characteristics, medical history, treatment regimens, and follow-up outcomes. Data will be entered and verified by professionals to ensure accuracy and completeness. Quality Control: Strict quality control measures will be implemented, including data audits, sample management, and laboratory testing. Regular reviews and validations of the data will be conducted to ensure the reliability and replicability of the study results. Data Security: The privacy and personal information of participants will be protected. All data will be stored in a secure environment and comply with relevant laws, regulations, and ethical guidelines. Ethical Review: The research protocol has been approved by the ethics committee, ensuring that the conduct of the study meets ethical standards and the protection of patient rights. ### Conditions Module **Conditions:** - Recurrent Liver Cancer - Primary Liver Cancer **Keywords:** - Recurrent Liver Cancer - Primary Liver Cancer ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 2 Years ### Arms Interventions Module #### Arm Group 1 **Description:** The training set for recurrent liver cancer patients is a subset of data collected from individuals who have been diagnosed with liver cancer that has returned after a period of remission or initial treatment. This data set is used to train machine learning models or other statistical methods to identify patterns or biomarkers that are indicative of cancer recurrence. The training set typically includes information such as patient demographics, medical history, previous treatments, and biological data, such as genetic mutations, protein levels, or imaging results. The goal is to use this data to develop a model that can accurately predict the recurrence of liver cancer in other patients, which can then be validated and tested using a separate data set, known as the validation set. **Label:** Training Set for Recurrent Liver Cancer Patient #### Arm Group 2 **Description:** The validation set for recurrent liver cancer patients is a distinct subset of data that is used to assess the performance and generalizability of a model or hypothesis developed from a training set. This set includes data from patients with recurrent liver cancer who were not part of the original training set. The purpose of the validation set is to test the model's ability to accurately predict or classify cases of recurrent liver cancer in a population that it has not been exposed to during its training phase. **Label:** Validation Set for Recurrent Liver Cancer Patient ### Outcomes Module #### Primary Outcomes **Description:** The primary outcome is to determine the sensitivity and specificity of the novel protein indicator in predicting the recurrence of liver cancer. This will be assessed by constructing a Receiver Operating Characteristic (ROC) curve and establishing a threshold value that maximizes the true positive rate (sensitivity) and minimizes the false positive rate (1-specificity). The ROC curve will visually represent the trade-off between sensitivity and specificity for different threshold values. **Measure:** Sensitivity and Specificity of the Novel Protein Indicator **Time Frame:** Assessed at the end of the study (up to 3 years), once all patient data has been collected and analyzed. **Description:** The secondary outcome is to calculate the positive predictive value (PPV) and negative predictive value (NPV) of the novel protein indicator. The PPV represents the probability that patients with an elevated indicator level will experience cancer recurrence, while the NPV represents the probability that patients with a non-elevated indicator level will remain free of recurrence. These values will provide insight into the clinical utility of the indicator. **Measure:** Positive and Negative Predictive Values **Time Frame:** Calculated after the threshold value has been determined and applied to the patient data (up to 3 years). #### Secondary Outcomes **Description:** Overall survival (OS) is a critical endpoint that measures the length of time from the start of the study until the death of a patient. It provides an assessment of the long-term outcome for patients with liver cancer and will be used to evaluate the prognostic value of the novel protein indicator. **Measure:** Overall Survival (OS) **Time Frame:** Monitored throughout the study and reported at 1 year, 2 years, and study completion (up to 5 years). **Description:** Progression-free survival (PFS) is the length of time during and after the treatment of a disease that a patient lives without the disease getting worse. In the context of this study, PFS will be used to measure the time from study entry until the cancer progresses or the patient dies from any cause, providing an intermediate endpoint that reflects the control of disease progression. **Measure:** Progression-Free Survival (PFS) **Time Frame:** Assessed at each follow-up visit, every 3 months for the first 2 years, then every 6 months until study completion (up to 5 years). **Description:** Disease-free survival (DFS) is the period after treatment during which there is no evidence of active cancer. It is a measure of the effectiveness of treatment in eliminating cancer cells. DFS will be calculated from the time of treatment initiation until the first sign of cancer recurrence or the end of the study. **Measure:** Disease-Free Survival (DFS) **Time Frame:** Monitored and reported at 6 months, 1 year, 2 years, and study completion (up to 5 years). **Description:** Time to progression (TTP) is the interval from the start of treatment until the tumor progresses or the patient's condition worsens to a defined level. This endpoint is particularly relevant for evaluating the effectiveness of the novel protein indicator in predicting and monitoring disease progression. **Measure:** Time to Progression (TTP) **Time Frame:** Measured from the initiation of the study intervention until progression or defined worsening, assessed at each follow-up visit (every 3 months for the first 2 years, then every 6 months until study completion, up to 5 years). ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosed with primary hepatocellular carcinoma or diagnosed with non-HCC * The patient or the patient's legal representative must be able to read, understand, and sign the informed consent form * Agree to provide blood samples and have good clinical compliance * Complete clinical basic information, including: the patient's unique traceability number (ID card number/outpatient number/health insurance card number), age, gender, imaging and/or pathological diagnosis results (for patients with primary liver disease), imaging examination confirmed heteromorphic liver cancer (for non-HCC patients) Exclusion Criteria: * Pregnant women * Those who have received organ transplantation * Non-HCC patients diagnosed with other tumors * Patients with primary hepatocellular carcinoma complicated by other tumors * Those judged by the researcher as not meeting the inclusion criteria **Healthy Volunteers:** True **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study population includes patients with primary hepatocellular carcinoma (HCC) and non-HCC liver cancers. Inclusion criteria are: diagnosis of primary HCC or non-HCC, ability to provide informed consent, agreement to supply blood samples, and clinical data completeness. Exclusion criteria include pregnancy, organ transplantation, other tumor diagnoses in non-HCC patients, HCC with other tumors, and researcher-determined ineligibility. The sample size is limited to ensure data precision and study validity. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** zhang yewei, doctor **Phone:** +86 13813885788 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Nanjing Medical University **Name:** zhang yewei, doctor **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000008107 - Term: Liver 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 - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14850 - Name: Recurrence - Relevance: HIGH - As Found: Recurrent - ID: M11113 - Name: Liver Neoplasms - Relevance: HIGH - As Found: Liver Cancer - ID: M22700 - Name: Disease Attributes - 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: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown - ID: T4700 - Name: Primary Liver Cancer - Relevance: HIGH - As Found: Primary liver cancer ### Condition Browse Module - Meshes - ID: D000008113 - Term: Liver Neoplasms - ID: D000012008 - Term: Recurrence ### 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:** NCT06430970 **Brief Title:** Prevalence Of Significant Endoscopic and Histopathologic Findings in Patients Presenting With Unexplained Iron Deficiency Anemia **Official Title:** Prevalence Of Significant Endoscopic and Histopathologic Findings in Patients Presenting With Unexplained Iron Deficiency Anemia: A Single Center Prospective Study #### Organization Study ID Info **ID:** MS.22.05.2001 #### Organization **Class:** OTHER **Full Name:** Mansoura University ### Status Module #### Completion Date **Date:** 2025-01-01 **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:** 2025-01-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-18 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mansoura University #### Responsible Party **Investigator Affiliation:** Mansoura University **Investigator Full Name:** Asmaa Gameel **Investigator Title:** Dr **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Background In practice, however, not all anaemic patients undergo appropriate diagnostic tests for the detection of iron deficiency anemia (IDA), and a significant portion of patients with IDA do not receive endoscopic evaluations. Accordingly, this study aimed to detect the prevalence of significant endoscopic (upper and lower endoscopy) and pathological findings in patients presenting with unexplained iron deficiency anaemia. Methods One hundred twenty-four patients with confirmed IDA with no obvious cause who visited the Internal Medicine Clinic were randomly selected. Patients with active bleeding, pregnant or lactating females, or those with contraindications to sedation were excluded. Upper and lower endoscopy were held in the endoscopy unit of Specialized Medical Hospital and tissue biopsy from significant endoscopic findings was sent for histopathological examination. **Detailed Description:** Methods This is an open label prospective study conducted on one hundered twenty four patients with IDA who attended to the Endoscopy Unit, Specialized Medical hospital, Mansoura University. Patients with active bleeding, pregnant or lactating female, contraindication of sedation (uncontrolled diabetes mellitus, uncontrolled thyroid disorders, pregnancy, respiratory embarrassment) were excluded. The study protocol was approved by our ethical committee, and written consents were taken from all subjects before the procedure. Measures All patients underwent Complete blood count (CBC) with detection of specific hematological parameters Serum ferritin, Iron and Total iron binding capacity, INR, serum albumin and bilirubin levels, ALT (Alanine Aminotransferase), AST (Aspartate aminotransferase), ESR, serum creatinine, occult blood in stool (FOBT kits ) small sample of stool collected in clean container, usually taken on consecutive days with precaution before testing include stopping non-steroidal anti-inflammatory drugs, vitamin C tablets ,raw vegetables and fruits and red meat often 48h to 72hour before test as they give false positive test (5) using immunochemical assay which detect globin chain of hemoglobin (6). All those proved with unexplained iron deficiency anemia were prepared to perform upper endoscopy and colonoscopy in later appointment. Procedures Esophgogastroduodenoscopy and colonscopy were performed in our endoscopy unit by the same endoscopist under conscious sedation, Endoscopic examination was done by (PENTAX medical EPK-I 5000, Tokyo, Japan). We usually started with colonscopic examintion. Complete ileocolonscopy was done to all patients then esohgeogastroduoenoscopy , any macroscopic lesion was detedcted ,documented and tissue biopsy was taken and sent for histopathological examination by the same pathologist. ### Conditions Module **Conditions:** - Gastrointestinal Diseases ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 124 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Device: endoscopy **Label:** patients with iron deficiency anemia **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - patients with iron deficiency anemia **Description:** upper and lower endoscopy **Name:** endoscopy **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Measure:** diagnosis of the cause of anemia **Time Frame:** two years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * • Sex: both * Age: from 18 to 70 years * Cases confirmed iron deciency anemia with no obvious cause. * Significant UGI pathology includes Barrett's esophagus, esophagitis (LA class ≥ C), esophagogastric varices, peptic ulcer disease, duodenal ulcer, angioectasia , and cancer (Wuerth BA and Rockey DC,2018). * Significant LGI pathology includes adenomatous polyps \>1cm, angioectasias, rectal ulcer, IBS , colon polyps and cancer. ( Ghassemi KA and Jensen DM,2013). Exclusion Criteria: * Patients with active bleeding, pregnant or lactating female, contraindication of sedation (uncontrolled diabetes mellitus, uncontrolled thyroid disorders, pregnancy, respiratory embarrassment) were excluded. **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:** Asmaa Gameel, MD **Phone:** 01025835429 **Phone Ext:** 02 **Role:** CONTACT #### Locations **Location 1:** **City:** Mansoura **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Asmaa Gameel, MD - **Phone:** 01025835429 - **Role:** CONTACT **Country:** Egypt **Facility:** Mansoura University **State:** Dakhlia **Status:** RECRUITING **Zip:** 35516 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000000740 - Term: Anemia - ID: D000006402 - Term: Hematologic Diseases - ID: D000019189 - Term: Iron Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000000747 - Term: Anemia, Hypochromic ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System 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: M8883 - Name: Gastrointestinal Diseases - Relevance: HIGH - As Found: Gastrointestinal Diseases - ID: M7255 - Name: Digestive System Diseases - Relevance: HIGH - As Found: Gastrointestinal Diseases - ID: M20857 - Name: Anemia, Iron-Deficiency - Relevance: HIGH - As Found: Iron Deficiency Anemia - ID: M2781 - Name: Iron Deficiencies - Relevance: HIGH - As Found: Iron Deficiency - ID: M4070 - Name: Anemia - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic 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 ### Condition Browse Module - Meshes - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - 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 ### Intervention Browse Module - Browse Leaves - ID: M10533 - Name: Iron - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430957 **Brief Title:** OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia **Official Title:** Evaluation of OSA Risk Levels in the Preoperative Period of Adult Patients With Planned Dental Procedures Under Anesthesia and Correlation With Postoperative Complications; A Multicenter Study #### Organization Study ID Info **ID:** KU-ERKAN-002 #### Organization **Class:** OTHER **Full Name:** Kırıkkale University ### Status Module #### Completion Date **Date:** 2025-08-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-20 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** TC Erciyes University #### Lead Sponsor **Class:** OTHER **Name:** Kırıkkale University #### Responsible Party **Investigator Affiliation:** Kırıkkale University **Investigator Full Name:** Gözde Nur Erkan **Investigator Title:** Assistant Professor Doctor, 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:** Obstructive sleep apnea (OSA) is a sleep-related respiratory dysfunction. The prevalence of OSA is increasing with the increasing rates of obesity and elderly population worldwide. Perioperative anesthesia management should be adjusted to improve patient safety in patients with OSA. In OSA patients, positive pressure ventilation support may be required in the preoperative period, various ventilation strategies may be required in the intraoperative period, different pharmacologic agents may need to be avoided, and intensive care unit follow-up or noninvasive ventilation support may be required in the postoperative period. However, it is reported that a significant percentage of OSA patients remain undiagnosed. ASA (American Society of Anesthesiologists) has reported the criteria that should be questioned in order to determine the risk of patients in terms of OSA and to initiate the diagnostic process in risky patients and to make appropriate anesthesiologic arrangements in the perioperative period. In addition, the STOP-BANG assessment scale, which is widely used all over the world in OSA risk assessment, is also used in OSA risk assessment. It is thought that dental caries and extraction needs may be higher in OSA patients, especially since open-mouth sleeping accompanies the situation. In this respect, it is also important for patients to be diagnosed with OSA as it may prevent dental damage due to open-mouth sleeping in the future. Identifying patients at risk for OSA and directing them to the diagnostic process is very important for patient safety. Within the scope of the study, the criteria recommended by ASA and STOP-BANG score will be evaluated and recorded. Risk stratification in terms of STOP-BANG questionnaire and ASA criteria will be done separately for each patient and for each classification method. Patients at high risk will be consulted to the relevant medical department in the preoperative period for further investigation and treatment. In addition, it is aimed to correlate the risk levels determined in the study with postoperative respiratory complications and recovery time. ### Conditions Module **Conditions:** - Obstructive Sleep Apnea Risk Management - Postoperative Complications - Dental Caries Under General Anesthesia - Obstructive Sleep Apnea of Adult ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 240 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Study group including patients in the low-risk group in the assessment to be made with STOP-BANG questionnaire. **Intervention Names:** - Other: The STOP-BANG questionnaire for determining OSA risk level. - Other: Record of postoperative complications **Label:** Group lowSTOP-B #### Arm Group 2 **Description:** Study group including patients in the medium-risk group in the assessment to be made with STOP-BANG questionnaire. **Intervention Names:** - Other: The STOP-BANG questionnaire for determining OSA risk level. - Other: Record of postoperative complications **Label:** Group intermediateSTOP-B #### Arm Group 3 **Description:** Study group including patients in the high-risk group in the assessment to be made with STOP-BANG questionnaire. **Intervention Names:** - Other: The STOP-BANG questionnaire for determining OSA risk level. - Other: Record of postoperative complications **Label:** Group highSTOP-B #### Arm Group 4 **Description:** The study group that includes patients who are not at risk for OSA in the evaluation with the criteria recommended by the ASA. **Intervention Names:** - Other: ASA recommended criteria for determining OSA risk level. - Other: Record of postoperative complications **Label:** Group noneASA #### Arm Group 5 **Description:** Study group including patients in the mild-risk group for OSA in the evaluation with the criteria recommended by the ASA. **Intervention Names:** - Other: ASA recommended criteria for determining OSA risk level. - Other: Record of postoperative complications **Label:** Group mildASA #### Arm Group 6 **Description:** Study group including patients in the moderate-risk group for OSA in the evaluation with the criteria recommended by the ASA. **Intervention Names:** - Other: ASA recommended criteria for determining OSA risk level. - Other: Record of postoperative complications **Label:** Group moderateASA #### Arm Group 7 **Description:** Study group including patients in the severe-risk group for OSA in the evaluation with the criteria recommended by the ASA. **Intervention Names:** - Other: ASA recommended criteria for determining OSA risk level. - Other: Record of postoperative complications **Label:** Group severeASA ### Interventions #### Intervention 1 **Arm Group Labels:** - Group highSTOP-B - Group intermediateSTOP-B - Group lowSTOP-B **Description:** An assessment questionnaire including OSA-related physical characteristics and symptoms and signs to be questioned individually in each patient will be examined by the physician. **Name:** The STOP-BANG questionnaire for determining OSA risk level. **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Group mildASA - Group moderateASA - Group noneASA - Group severeASA **Description:** An assessment questionnaire including OSA-related physical characteristics and symptoms and signs to be questioned individually in each patient will be examined by the physician. **Name:** ASA recommended criteria for determining OSA risk level. **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Group highSTOP-B - Group intermediateSTOP-B - Group lowSTOP-B - Group mildASA - Group moderateASA - Group noneASA - Group severeASA **Description:** Respiratory complications as laryngospasm/bronchospasm, apnea, hypoxia, duration and amount of need for additional oxygen support and recovery time (duration of modified aldrete score of 9 and above) will be recorded. **Name:** Record of postoperative complications **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The STOP-BANG questionnaire and the criteria recommended by the ASA, which are recommended to be used routinely worldwide to determine OSA risk level, will be questioned in each patient. Patients with moderate and high risk scores from the STOP-BANG questionnaire and patients with significant OSA risk level according to ASA criteria will be referred to the pulmonology department and further evaluation will be requested. If deemed necessary by the Pulmonology department, a sleep test will be performed. With the sleep test result, the OSA risk level of the patients will be classified as none, mild, moderate and severe in terms of ASA criteria. **Measure:** Determination of OSA risk levels of patients **Time Frame:** Preoperative period **Description:** Respiratory complications including laryngospasm/bronchospasm, apnea, hypoxia that may develop in the postoperative period in patients, the duration of the need for additional oxygen support above the expected duration will be observed and recorded. **Measure:** Postoperative respiratory complications **Time Frame:** For 4 hours after the end of surgery **Description:** As indicators of airway obstruction; snoring/whistling respiration, hypertension and intercostal/sternal retractions will be observed and recorded in the study follow-up form. **Measure:** Follow-up of indicators of airway obstruction **Time Frame:** For 4 hours after the end of surgery **Description:** Duration of recovery (modified aldrete score of 9 and above) will be recorded **Measure:** Duration of recovery **Time Frame:** For 30 minutes after the end of surgery #### Secondary Outcomes **Description:** Patients who will receive an intermediate or high risk score from either of the two assessment questionnaires will be referred for further evaluation and diagnosis of suspected OSA. At the end of the diagnostic process, it is planned to investigate which of the two scoring systems more successfully identifies patients with OSA and assigns a higher risk. **Measure:** Comparison of the effectiveness of STOP-BANG questionnaire and ASA criteria in determining OSA risk level **Time Frame:** Perioperative period ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients between 18-80 years of age who apply to the anesthesia clinic for dental procedures planned to be performed under general anesthesia * Patients without a previous diagnosis of OSA Exclusion Criteria: * Individuals who do not want to participate in the study * Patients previously diagnosed with OSA * Necessity of emergency surgery **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients between the ages of 18-80 years who applied to the anesthesia clinic for dental procedures planned to be performed under general anesthesia and who had no previous diagnosis of OSA. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Gözde Nur Erkan, Asst. Prof. **Phone:** +905054334692 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## 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 - ID: D000010335 - Term: Pathologic Processes - ID: D000017001 - Term: Tooth Demineralization - ID: D000014076 - Term: Tooth Diseases - ID: D000009057 - Term: Stomatognathic 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: BC07 - Name: Mouth and Tooth Diseases - 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: M6928 - Name: Dental Caries - Relevance: HIGH - As Found: Dental Caries - ID: M14065 - Name: Postoperative Complications - Relevance: HIGH - As Found: Postoperative Complications - ID: M4361 - Name: Apnea - Relevance: HIGH - As Found: Apnea - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - 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 - ID: M19339 - Name: Tooth Demineralization - 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: D000003731 - Term: Dental Caries - ID: D000001049 - Term: Apnea - ID: D000012891 - Term: Sleep Apnea Syndromes - ID: D000020181 - Term: Sleep Apnea, Obstructive - ID: D000011183 - Term: Postoperative Complications ### 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:** NCT06430944 **Brief Title:** Comparative Study Between Single and Double Limb Hip Spica Cast in Fracture Femur in Young Children **Official Title:** Comparative Study Between Single and Double Limb Hip Spica Cast in Fracture Femur in Young Children #### Organization Study ID Info **ID:** MS-318-2023 #### Organization **Class:** OTHER **Full Name:** Kasr El Aini Hospital ### Status Module #### Completion Date **Date:** 2024-01-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-01-30 **Type:** ACTUAL #### Start Date **Date:** 2022-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Kasr El Aini Hospital #### Responsible Party **Investigator Affiliation:** Kasr El Aini Hospital **Investigator Full Name:** Ahmed Omar Sabry **Investigator Title:** Dr. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** We performed a randomized control trial including 84 children aged two to six years who presented with femoral fractures. They were randomized into two groups; the first was managed by single limb cast fixation (42 patients), and the second was managed by double limb cast fixation (42 patients). The primary outcomes were postprocedural functional outcomes and parents' satisfaction, while the secondary outcomes were the rates of complications. **Detailed Description:** Femoral fractures are frequent in children and compose 1% to 2% of all pediatric fractures. Conservative management is associated with good results, whether by single or double-limb cast fixations. We aim to compare both procedures regarding functional outcomes, complications, and parents' satisfaction. Eighty-four children were eligible to be included in our study; 42 underwent single limb spica casts, and the other 42 patients underwent double limb spica casts. Both groups had similar baseline characteristics like age, gender, fracture side, and fracture classification. ### Conditions Module **Conditions:** - Femur Fracture ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 84 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A folded towel was placed inside the tubular bandage over the centre of the abdomen, which helped create breathing space inside the cast. The towel's tail was brought towards the neck for easier removal. Then, a layer of the padded cast was applied using a large width for the body and a narrower one for the lower limb. A thick felt was added over this padding along the free edges of the chest and the leg. The first layer of the cast was applied to the leg and body in an eight-figure manner, taking care to connect the leg to the body securely. The reinforced cast slabs were applied between the body and the lower limb segments. The thigh segment was moulded to maintain a good reduction by keeping the anterolateral of the cast flat or slightly concave. Some clinicians moulded the segment enough to result in ten degrees of initial valgus. **Intervention Names:** - Procedure: Placing a hip spica cast for patients with femur fractures **Label:** Single limb spica casting: **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** One and a half cast was applied in a single limb spica cast, extending to the opposite leg to the knee. Reinforced slabs were applied to hip joints in both limbs **Intervention Names:** - Procedure: Placing a hip spica cast for patients with femur fractures **Label:** Double limb spica cast: **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Double limb spica cast: - Single limb spica casting: **Description:** Placing a hip spica cast for patients with femur fractures. These hip spicas are made for each patient to stabilize the fracture in pediatric patients **Name:** Placing a hip spica cast for patients with femur fractures **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The Flynn evaluation system is based on the presence of leg length inequality, malalignment, pain, and minor and major complications. Each of these criteria is either defined as Excellent, successful or poor. **Measure:** Flynn's score **Time Frame:** 6 months #### Secondary Outcomes **Description:** we do xrays to confirm if there is any loss of reduction of the fracture **Measure:** loss of reduction **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * children aged 2 to 6 years * Children with femur shaft fractures Exclusion Criteria: * Children younger than 2 years or older than 6 years * Articular fractures or fractures that cant be managed with a cast * Old fractures older than 3 weeks **Maximum Age:** 6 Years **Minimum Age:** 2 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Kasr Al Ainy-Cairo University- Faculty of Medicine **State:** Manial **Zip:** 11956 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014947 - Term: Wounds and Injuries - ID: D000007869 - Term: Leg Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M26370 - Name: Fractures, Bone - Relevance: HIGH - As Found: Fracture - ID: M8402 - Name: Femoral Fractures - Relevance: HIGH - As Found: Femur Fracture - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M10881 - Name: Leg Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000050723 - Term: Fractures, Bone - ID: D000005264 - Term: Femoral Fractures ### 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:** NCT06430931 **Acronym:** ProTex **Brief Title:** Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery **Official Title:** Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery: a Multicentre, Phase 11-111, Partially Randomised Patient Preference Trial #### Organization Study ID Info **ID:** NL79184.100.22 #### Organization **Class:** OTHER **Full Name:** Meander Medical Center ### Status Module #### Completion Date **Date:** 2026-07-01 **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:** 2026-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-12-06 **Type:** ACTUAL **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-02 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Health Holland #### Lead Sponsor **Class:** OTHER **Name:** Meander Medical Center #### Responsible Party **Investigator Affiliation:** Meander Medical Center **Investigator Full Name:** Esther Consten **Investigator Title:** Clinical Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This prospective study aims to assess the efficacy of the OviTex 1S permanent mesh in pelvic floor surgery in comparison with the current standard polypropylene mesh. **Detailed Description:** Minimal-invasive ventral mesh rectopexy (VMR) and sacrocolporectopexy (SCR) or cervicopexy are widely accepted treatments for patients suffering from pelvic prolapse. Choice of material used in VMR or SCRP - synthetic or biologic surgical mesh - remains subject of debate. Recent ban in the usage of non abdominal but transvaginal, mesh for pelvic organ prolapse (POP) in April 2019, by the Food and Drug Administration (FDA) has negatively influenced the perception on all sorts of surgical mesh. Currently, the most widely used mesh in VMR is synthetic and has shown good results regarding recurrence, mesh exposure and functional outcome. Although complication rates are low, the serious complications of fistulation, exposition, and dyspareunia are reasons to opt for a more expensive biological mesh. High-quality evidence of synthetic versus biological mesh is lacking, which does not stop resistance against synthetic mesh from growing. This has even led to concerns and questions about synthetic mesh use from the Dutch government addressed at the medical professionals and options for alternatives are being asked. Biological grafts are characterized by degradation of the implant and regeneration of host tissue. It is assumed that this process of degradation and remodeling decreases the risk of exposition and infection. However, this transformation may possibly lead to a higher chance of recurrence in the long term. Rate of recurrence, but also graft-related complications (GRC) to a lesser extent, largely depends on duration of follow-up. Since biological graft implementation in VMR and SCR is relatively new and its usage is restricted due to higher costs, evidence on biological mesh with long term follow-up is limited. In addition, there is a significant difference in various described biological meshes. This is important to keep in mind when comparing outcome of VMR or SCR with synthetic versus biologic mesh. In VMR there are no randomised controlled trials on synthetic versus biological mesh. The biological meshes studied thus far are Biodesign and Permacol. Mesh exposure rates after VMR with Biodesign and Permacol have both been studied in three studies in total (N = 349 and N = 425 in total respectively) and show low mesh exposure rates of 0 to 0.1%. In comparison, GRC after VMR with synthetic non-resorbable mesh (like polypropylene) are around 2%. Recurrence rates after synthetic mesh in VMR range between 2% and 14% after a median follow-up of 12-61 months. When comparing studies on biologic implants that report on recurrence rates there seems to be a slight difference in favor of Biodesign. Studies on Biodesign in VMR with a median follow-up ranging between 12 and 47 months show a recurrence rate around 5%. Literature on Permacol shows higher recurrence rates ranging between 5 to 14% after a median follow-up of 12 to 29 months. In sacrocolpopexy (SCP) allografts and xenografts have been investigated as an alternative for polypropylene. A randomised controlled trial compared SCP using polypropylene mesh with solvent cadaveric fascia lata. After one year of follow-up, polypropylene mesh had a higher anatomical cure rate than cadaveric fascia lata (91 percent versus 68 percent; p=0.007). Two GRC occurred in patients who received polypropylene mesh, while none occurred in the allograft group (p= 0.5). Another RCT with the same comparison and a follow-up of 5 years showed similar results, with considering cadaveric fascia not as strong of a support. Deprest et al. compared polypropylene mesh with porcine grafts in a prospective study and found xenografts to be associated with more apical failures and reoperations than with a polypropylene mesh (21 percent versus 3 percent; p = 0.01).However, there was no significant difference in functional outcomes between the two groups. An exposure rate of 11 percent was described in both groups. A more recent study concluded, by analyzing clinical outcomes and patients satisfaction, that a non-crosslinked ADM patch can be a good alternative to synthetic polypropylene mesh in patients undergoing SCP. Although Biodesign (Surgisis), Permacol and other are all grouped under the common denominator 'Biologic mesh', each of these products is unique. There are differences in tissue source, differences in the processes used to decellularize the tissue and differences in the final processing steps such as sterilization and preservation. As a result, there are significant variations in biological and clinical performance between these products. Permacol, which is purposely cross-linked pig dermis, behaves like a synthetic material in-vivo and induces a permanent foreign body response, leading to encapsulation. This prevents integration with and in the surrounding tissue. Consequently, high rates of mesh exposure occur with Permacol implants. Biodesign, one of the early biologics, is derived from small intestinal submucosa and is a non-cross-linked mesh. Likely due to its (proprietary) processing, Biodesign in practice often dissolves before healing and remodeling can take place. A novelty on the surgical mesh market is OviTex. It is produced by Aroa Biosurgery and consist of sterile sheep extracellular matrix (ECM) interwoven with a (absorbable or non-absorbable) synthetic fiber. OviTex comes with a grid of absorbable polyglycolic acid (PGA) or permanent polypropylene and with differing amounts of layers (Core, 1S and 2S). Unique to OviTex is its composition, which consists of essential components required for regeneration of host tissue. Additionally, the coupling of an ECM with a (absorbable) synthetic fiber provide strength without the need to cross-link the ECM. Moreover, OviTex is lower in costs than any other biological mesh on the market. Since the use of synthetic meshes in pelvic floor surgery has come under scrutiny, patients are tempted to undergo a resection rectopexy as an alternative to VMR with polypropylene. Apart from the fact that the resection is associated with a higher risk of complications due to the application of an anastomosis, the recovery time is much longer. The hospitalization period would be longer and therefore the costs compared to prolapse surgery with OviTex would be higher. Preliminary results of a recent pilot study at Meander MC showed that the use of an OviTex PGA (with absorbable grid) mesh in the pelvic floor is feasible and safe. Nevertheless, 2 out of 11 patients who completed follow-up of 6 months showed an early anatomical recurrence. This suggests that the use of permanent synthetic fiber may be necessary for a more durable repair and fewer recurrences than using OviTex PGA. Although resistance against synthetic grafts is growing, OviTex Permanent contains 96% sheep ECM and only 4% polymer, compared to the standard Prolene mesh which is 100% polymer (polymer areal density 16g/m2 OviTex 1S vs. 76g/m2 prolene). Furthermore, the polymer is embedded in the ECM which further attenuates any inflammatory response. Observations in primates show that the minimized amount of embedded synthetic reinforcement results in an implant that, histologically, behaves like a biologic mesh yet maintains its functional structure. This is the first prospective multicenter study using a OviTex 1S mesh. Although the material ovine was studies before, little is known about the feasibility of enrolling these patients into randomised studies in the Netherlands and about the feasibility, safety, and tolerance of the OviTex 1s is this setting. Therefore, the investigators decided to start with a phase II study. This allows for adequate monitoring of the feasibility, safety, and tolerance of the experimental treatment. There are no studies comparing OviTex to the current standard (Prolene, PMN3, Ethicon Inc Johnson \& Johnson, Amersfoort, The Netherlands) Therefore, a comparative study should be conducted before OviTex is used as a biologic alternative for polypropylene in VMR on a larger scale. Following the OviTex pilot study, the investigators aim to conduct a follow-up study (ProTex trial) in which, both in the short and longer term, the efficacy of the OviTex mesh in pelvic floor surgery will be assessed in comparison with the current standard polypropylene, by means of a non-inferiority test. ### Conditions Module **Conditions:** - Colorectal Disorders - Prolapse - Prolapse Rectal - Prolapse Genital - Prolapse Pelvic - Rectocele - Prolapse Uterus - Cystocele - Enterocele - Prolapse Bladder - Prolapse; Cervix **Keywords:** - Prolapse - Abdominal prolapse Surgery - Biological mesh - OviTex - VMR - sacrocolporectopexy ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Multi-centre prospective non-inferior patient-preference study ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 184 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Polypropylene mesh (Prolene, PMN3, Ethicon Inc Johnson \& Johnson, Amersfoort, The Netherlands; weight 78 g/m2) **Intervention Names:** - Procedure: Minimal invasive abdominal prolapse surgery using Polypropylene mesh **Label:** Polypropylene mesh **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** OviTex Reinforced BioScaffold, Permanent Polymer composed of ovine (sheep) forestomach extracellular matrix (ECM) and polypropylene. **Intervention Names:** - Procedure: Minimal invasive abdominal prolapse surgery using OviTex 1S permanent mesh **Label:** OviTex 1S permanent mesh **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Polypropylene mesh **Description:** All procedures will be performed with robotic assistance of the da Vinci Si-HD (intuitive Surgical, Inc, Sunnyvale, CA). **Name:** Minimal invasive abdominal prolapse surgery using Polypropylene mesh **Other Names:** - Ventral mesh rectopexy - Sacrocolporectopexy **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - OviTex 1S permanent mesh **Description:** All procedures will be performed with robotic assistance of the da Vinci Si-HD (intuitive Surgical, Inc, Sunnyvale, CA). **Name:** Minimal invasive abdominal prolapse surgery using OviTex 1S permanent mesh **Other Names:** - Ventral mesh rectopexy - Sacrocolporectopexy **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Post-operative complications. The Clavien Dindo Classification is used to rank the severity of a surgical complication **Measure:** Main study parameter/endpoint phase II: rate of complications **Time Frame:** 90days postoperative **Description:** Post-operative morbidity measured by reoperations, reinterventions, readmissions, **Measure:** Main study parameter/endpoint phase ll: number of participants with post-operative morbidity **Time Frame:** 90days postoperative **Description:** Constipation, incontinence and urogenital functioning (questionnaire, validated scoring system: Pelvic Floor Distress lnventory-20 (PFDl-20). The Pelvic Floor Distress Inventory-20 (PFDI-20) is a questionnaire used to assess the presence and severity of symptoms related to pelvic floor disorders. The PFDI-20 consists of 20 questions divided into three subscales: the Pelvic Organ Prolapse Distress Inventory (POPDI), the Colorectal-Anal Distress Inventory (CRADI), and the Urinary Distress Inventory (UDI). Scale Details: Minimum Score: 0 Maximum Score: 300 Interpretation: Higher scores indicate a worse outcome, reflecting greater distress or more severe symptoms. **Measure:** Main study parameter/endpoint phase Ill: Pelvic Floor Distress lnventory-20 score (PFDl-20) **Time Frame:** 12 months postoperative #### Secondary Outcomes **Description:** Questionnaire, validated scoring system: Altomare obstructive defecation score (ODS) with a maximum score of 31. A higher score on the Altomare scale indicates a greater severity of constipation. Scores will be compared before and after treatment. **Measure:** Constipation **Time Frame:** 12 months postoperative **Description:** Questionnaire, validated scoring system: Fecal Incontinence Severity Index (FISI) with a maximum score of 60. A higher FISI score indicates more severe fecal incontinence. Scores will be compared before and after treatment. **Measure:** Incontinence **Time Frame:** 12 months postoperative **Description:** Objectified primarily by the Patient Global Impression of Improvement (PGl-I). The PGI-I scale measures the patient's perception of improvement (or lack thereof) in their condition following treatment. 1 - Very much improved: Significant improvement in condition. 2 - Much improved: Noticeable improvement in condition. 3 - Minimally improved: Slight improvement in condition. 4 - No change: Condition has not changed. 5 - Minimally worse: Slight worsening of condition. 6 - Much worse: Noticeable worsening of condition. 7 - Very much worse: Significant worsening of condition. **Measure:** Quality of life (Qol) pre- and postoperatively by the Patient Global Impression of Improvement (PGl-I). **Time Frame:** 12 months postoperative **Description:** Objectified primarily by the Patient Global Impression of Severity (PGl-S). The PGI-S scale measures the patient's perception of the severity of their condition at a specific point in time. 1 - Normal: No symptoms. 2 - Borderline: Barely noticeable symptoms. 3 - Mild: Symptoms are present but do not significantly interfere with daily activities. 4 - Moderate: Symptoms are more noticeable and do interfere with daily activities. 5 - Severe: Symptoms are significant and very disruptive to daily activities. 6 - Very severe: Symptoms are extremely disruptive and may prevent daily activities. 7 - Extremely severe: Symptoms are debilitating. **Measure:** Quality of life (Qol) pre- and postoperatively by the Patient Global Impression of Severity (PGl-S). **Time Frame:** 12 months postoperative **Description:** Objectified primarily by the European Quality of Life Five Dimension (EQ-5D). The European Quality of Life Five Dimension (EQ-5D) measures health-related quality of life using a descriptive system with five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) rated at three severity levels, and an EQ visual analogue scale (EQ VAS) from 0 to 100 for overall health perception. **Measure:** Quality of life (Qol) pre- and postoperatively by the European Quality of Life Five Dimension (EQ-5D). **Time Frame:** 12 months postoperative **Description:** Objectified primarily by the Pelvic Floor impact Questionnaire (PFIQ-7). Higher scores on the PFIQ-7 indicate a greater negative impact of pelvic floor disorders on the patient's quality of life. **Measure:** Quality of life (Qol) pre- and postoperatively by the Pelvic Floor impact Questionnaire (PFIQ-7) **Time Frame:** 12 months postoperative **Description:** Measured by reoperations, reinterventions, readmissions, and serious adverse advents. **Measure:** Number of patients with post-operative morbidity **Time Frame:** 12 months postoperative **Description:** Measured by defecogram or MR defecography in rest and during Valsalva maneuver. **Measure:** Number of patients with anatomic recurrence of the rectal prolapse **Time Frame:** 12 months postoperative **Description:** Complaints, physical examination, addition research, re-operation and readmission **Measure:** Rate of rectal prolapse recurrence and complications **Time Frame:** 12 months postoperative **Description:** Using the simplified Pelvic Organ Prolapse Quantification (sPOPQ) **Measure:** Number of patients with anatomic recurrence of pelvic organ prolapse (POP) **Time Frame:** 12 months postoperative **Description:** By the questionnaire Prolapse Incontinence Sexual Inventory Questionnaire (PSIQ-IR). Lower Scores: Indicate greater sexual dysfunction and more issues related to the conditions. **Measure:** Sexual functioning pre- and postoperatively scores on the PSIQ-IR **Time Frame:** 12 months postoperative **Measure:** Length of hospital stay in days **Time Frame:** 12 months postoperative **Measure:** Rate of extra outpatient visits because of complaints **Time Frame:** 12 months postoperative ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Indication for VMR or SCR set by the treating surgeon/gynecologist in accordance to the current guidelines on rectal and pelvic prolapse; * Counselled for therapeutic options and given informed consent for VMR or SCR; * Counselled for different types of mesh (OviTex or Prolene) and randomisation; * Written informed consent for randomisation, OviTex implant or Prolene; * Written informed consent for observational data collection. Exclusion Criteria: * Mentally incompetent patients (unable to fulfil questionnaires). * Allergy to ovine rumen. * A medical history of pelvic radiation therapy. * Scheduled for a redo-rectopexy. * A medical history of previously implanted pelvic floor meshes or native tissue. * Language barrier **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Marije Boom, drs. **Phone:** + 31 33 850 1716 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Esther Consten, Prof.dr **Role:** CONTACT #### Locations **Location 1:** **City:** Amersfoort **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Marije Boom, drs. - **Phone:** +31 33 850 1716 - **Role:** CONTACT **Country:** Netherlands **Facility:** Meander Medisch Centrum **State:** Utrecht **Status:** RECRUITING **Zip:** 3813TZ #### Overall Officials **Official 1:** **Affiliation:** Meander Medisch Centrum **Name:** Esther Consten, Prof.dr **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000001745 - Term: Urinary Bladder Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000056887 - Term: Pelvic Organ Prolapse - ID: D000012002 - Term: Rectal Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions ### Condition Browse Module - Browse Leaves - ID: M14261 - Name: Prolapse - Relevance: HIGH - As Found: Prolapse - ID: M21893 - Name: Rectocele - Relevance: HIGH - As Found: Rectocele - ID: M27101 - Name: Cystocele - Relevance: HIGH - As Found: Cystocele - ID: M17344 - Name: Uterine Prolapse - Relevance: LOW - As Found: Unknown - ID: M14847 - Name: Rectal Prolapse - Relevance: LOW - As Found: Unknown - ID: M9625 - Name: Hernia - Relevance: HIGH - As Found: Enterocele - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M5026 - Name: Urinary Bladder Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M28618 - Name: Pelvic Organ Prolapse - Relevance: LOW - As Found: Unknown - ID: M14844 - Name: Rectal Diseases - 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 ### Condition Browse Module - Meshes - ID: D000020047 - Term: Rectocele - ID: D000052858 - Term: Cystocele - ID: D000011391 - Term: Prolapse - ID: D000006547 - Term: Hernia ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430918 **Brief Title:** Neuropathic Pain and it's Relation to Sleep Quality in Knee Osteoarthritis **Official Title:** Coexistence of Night Pain and Neuropathic Pain in Patients With Knee Osteoarthritis #### Organization Study ID Info **ID:** 226092BK #### Organization **Class:** OTHER **Full Name:** Bozyaka Training and Research Hospital ### Status Module #### Completion Date **Date:** 2025-05-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2025-03-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-16 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Bozyaka Training and Research Hospital #### Responsible Party **Investigator Affiliation:** Bozyaka Training and Research Hospital **Investigator Full Name:** Taciser Kaya **Investigator Title:** MD, 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 primary aim is to investigate the frequency and severity of neuropathic pain and its association with night pain in patients with knee osteoarthritis. For this purpose a progressive longitudinal study design was planned. The secondary aim is to investigate the relationship between night pain and neuropathic pain and sleep quality. **Detailed Description:** Osteoarthritis (OA) is the most common form of arthritis in the world. Classically, OA presents with joint pain and loss of function; however, the disease is clinically very variable and can present merely as an asymptomatic incidental finding to a devastating and permanently disabling disorder. The severity of knee pain caused by osteoarthritis, often does not correlate with the degree of degenerative changes in the joint. In patients reporting night pain, this may be related to inflammation, but in the absence of clinical and laboratory findings of inflammation, it is not possible to explain night pain only by the degree of joint damage. The existence of a relationship between night pain and neuropathic pain may be a guide in looking for neuropathic pain in patients who have night pain and experience this pain severely and thus for planning an appropriate treatment for the patient. Patients with stage 2-4 knee OA will be evaluated in terms of demographic variables and outcome measurement parameters specified in the case report form. The relationship between neuropathic pain scores and knee pain severity will be sought. It will be studied whether there is a difference in outcome measurement parameters between those with neuropathic pain and those without. Correlation analysis will be performed between sleep quality score and pain intensity scores. The determinants of sleep quality will be evaluated by regression analysis. American College of Rheumatology criteria will be recruited. Demographics and disease related variables will be recorded. ### Conditions Module **Conditions:** - Neuropathic Pain - Knee Osteoarthritis - Sleep Disturbance **Keywords:** - neuropathic pain - Knee Osteoarthritis - Sleep Disturbance ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Day ### Arms Interventions Module #### Arm Group 1 **Description:** Knee OA patients diagnosed according to the ACR Classification Criteria **Intervention Names:** - Other: physical examination, questionnaires and inventories **Label:** Patients with knee osteoarthritis ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients with knee osteoarthritis **Description:** Questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed. **Name:** physical examination, questionnaires and inventories **Other Names:** - Questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed. **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The DN4 questionnaire (4 Questions Neuropathic Pain Questionnaire) will be used. It is a clinician-administered questionnaire. It consists of ten items. Seven items related to pain quality (i.e. sensory and pain descriptors) are based on an interview with the patient. Three items are based on the clinical examination. The clinician assesses whether there is reduced sensation (hyposthesia) to touch or pinprick and whether light brushing increases or causes pain (allodynia). All of the positive items are scored as one point and total score is sum of the scores of these positive items. The diagnosis is based on 4/10 cut-off value. **Measure:** Neuropathic pain; 4 Questions Neuropathic Pain Questionnaire **Time Frame:** through study completion, an average of 1 year #### Secondary Outcomes **Description:** Jenkins Sleep Scale.The four-item questionnaire evaluates the frequency and intensity of certain sleep difficulties in respondents. Questions queries the number of days in which the patient was subjected to sleep problems. The maximum possible score is 20 and higher scores indicate much more sleep disturbance. A mean score of two or more is considered as sleep disturbance presence. **Measure:** Sleep quality **Time Frame:** through study completion, an average of 1 year **Description:** The Hospital Anxiety and Depression Scale (HADS) was developed by Zigmond and Snaith in 1983. It is used to detect whether the patient is in the depressive or anxious status. It is not a diagnostic tool but gives to physician an idea about the patient's emotional status. It consists of fourteen items. Seven items are related to anxiety and the other seven depression **Measure:** Depression and Anxiety; The Hospital Anxiety and Depression Scale (HADS) **Time Frame:** through study completion, an average of 1 year **Description:** KOOS evaluates the symptoms and functional problems related to knee OA and knee injury. It consists of five subscales. In this study authors intended to assess the life quality by using the quality of life level subscale of this scale. **Measure:** Quality of life level; KOOS (KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE) "Quality of Life" subgroup **Time Frame:** through study completion, an average of 1 year **Description:** Disability; KOOS (KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE) "Activities of Daily Life and Function" subgroup **Measure:** Disability; KOOS (KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE) "Activities of Daily Life and Function" subgroup **Time Frame:** through study completion, an average of 1 year **Description:** Participants will be asked to report the pain intensity that they feel on a line between 0 and 10, higher scores indicating more intense pain. **Measure:** Night pain (VAS, 0-10 cm) Participants will be asked to report the pain intensity that they feel on a line between 0 and 10, higher scores indicating more intense pain. **Time Frame:** through study completion, an average of 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Having a clinical diagnosis of knee osteoarthritis according to the American Rheumatology Association/ACR criteria 2. Knee OA is of Kellgren-Lawrence stage 2-4 3. The participant gives signed consent - Exclusion Criteria: Exclusion Criteria: 1. Having diabetes mellitus 2. Chronic kidney failure 3. Hypothyroidism 4. Presence of orthopedic disability (such as implant, prosthesis, contracture, shortness) in the lower extremity 4. Neurological diseases that can cause neuropathic pain 5. Presence of fibromyalgia 6. Malignancy 7. Pregnancy 8. Neurological deficit in the lower extremity 9. Drug use that may cause neuropathy (colchicine, etc.) İn the last 3 months 10. Drug use (antidepressant, antipsychotic, antiepileptic) due to sleep disturbance or widespread pain in the last 3 months. - **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with stage 2-4 knee OA will be evaluated in terms of demographic variables and outcome measurement parameters specified in the case report form. ### Contacts Locations Module #### Locations **Location 1:** **City:** Izmir **Country:** Turkey **Facility:** Izmir Bozyaka Training and Reseach Hospital **Zip:** 35300 #### Overall Officials **Official 1:** **Affiliation:** Izmir Bozyaka Training and Research Hospital İzmir, Turkey **Name:** Taciser Kaya, Prof. **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Izmir Bozyaka Training and Research Hospital İzmir, Turkey **Name:** Berna Kirilmaz Colak, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** Izmir Bozyaka Training and Research Hospital İzmir, Turkey **Name:** Bugra Ince, Assoc. prof. **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Hoper J, Schraml L, Gierthmuhlen J, Helfert SM, Rehm S, Hartig S, Schroder O, Lankes M, Traulsen FC, Seekamp A, Baron R. Changes of Somatosensory Phenotype in the Course of Disease in Osteoarthritis Patients. Int J Environ Res Public Health. 2020 Apr 29;17(9):3085. doi: 10.3390/ijerph17093085. **PMID:** 32365479 **Citation:** Wylde V, Palmer S, Learmonth ID, Dieppe P. Somatosensory abnormalities in knee OA. Rheumatology (Oxford). 2012 Mar;51(3):535-43. doi: 10.1093/rheumatology/ker343. Epub 2011 Nov 24. **PMID:** 22120461 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases - ID: D000010523 - Term: Peripheral Nervous System Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations - ID: D000012893 - Term: Sleep Wake Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal 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: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M22168 - Name: Osteoarthritis, Knee - Relevance: HIGH - As Found: Knee Osteoarthritis - ID: M12926 - Name: Osteoarthritis - Relevance: HIGH - As Found: Osteoarthritis - ID: M12381 - Name: Neuralgia - Relevance: HIGH - As Found: Neuropathic Pain - ID: M22242 - Name: Parasomnias - Relevance: HIGH - As Found: Sleep Disturbance - ID: M22655 - Name: Dyssomnias - Relevance: HIGH - As Found: Sleep Disturbance - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M4476 - Name: Arthritis - 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: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M13432 - Name: Peripheral Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M15696 - Name: Sleep Wake 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: D000010003 - Term: Osteoarthritis - ID: D000020370 - Term: Osteoarthritis, Knee - ID: D000009437 - Term: Neuralgia - ID: D000020920 - Term: Dyssomnias - ID: D000020447 - Term: Parasomnias ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430905 **Brief Title:** Safety, Reactogenicity and Immunogenicity of HB-502 and HB-501 Versus Placebo in People With HIV on Suppressive ART **Official Title:** A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Arenavirus-based Vector Therapy HB-502 and HB-501 in People With HIV on Suppressive Antiretroviral Treatment #### Organization Study ID Info **ID:** H-500-001 #### Organization **Class:** INDUSTRY **Full Name:** Hookipa Biotech GmbH ### Status Module #### Completion Date **Date:** 2025-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Hookipa Biotech GmbH #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a study of HB-502 and HB-501 alternating 2-vector therapy in people living with human immunodeficiency virus (HIV) who are taking antiretroviral treatment (ART). The benefits of available ART are short-lived and eventually there is a return of rapid HIV replication and higher viral copy number after a period of initial improvement of infection. The study treatment made of HB-502 and HB-501 is designed to train the body to recognize and fight parts from substances found in HIV. This trial studies the safety, tolerability, and ability of HB-502 and HB-501 to stimulate an immune response against HIV in people living with HIV. Participants will receive the study treatment by injection into the muscle every 8 weeks for a duration of 24 weeks, which is followed by another 24 weeks to continue looking closely at the safety profile and anti-HIV immune reaction after the last dose of study treatment. **Detailed Description:** This is a first-in-human Phase 1b, randomized, double-blind, placebo-controlled, multicenter study of HB-502 and HB-501 alternating 2-vector therapy in participants with HIV who are in overall good health and on suppressive ART. The study will evaluate the safety, reactogenicity, and immunogenicity of HB-502 and HB-501 alternating 2-vector therapy. HB-502 and HB-501 are genetically engineered replicating vectors based on the arenaviruses Pichinde virus and lymphocytic choriomeningitis virus, respectively. The HB-502 and HB-501 vectors have been engineered to deliver HIV antigens derived from parts of key, immunogenic regions of HIV type 1 (HIV-1) proteins that are highly conserved within HIV-1 clade B variants. The designed immunogens differ from each other by their amino acid sequence allowing for coverage of \>80% of circulating HIV-1 viral variants. Two different dose levels (Dose Level 1 and Dose Level 2) of HB-502 and HB-501 alternating 2-vector therapy or placebo will be administered intramuscularly every 8 weeks for 24 weeks (i.e., 4 doses at Weeks 0, 8, 16, and 24), which is followed by a 24-week follow-up period. In total, approximately 30 participants aged 18 to 65 years will be enrolled in this study to receive HB-502 and HB-501 alternating 2-vector therapy or placebo. About 5 Investigators and study sites in the United States are expected to participate in this study. ### Conditions Module **Conditions:** - Human Immunodeficiency Virus (HIV) Infection **Keywords:** - human immunodeficiency virus - HIV - vaccine - immunotherapy - arenavirus - genetic vector - antiretroviral therapy - ART ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Intramuscular injection of HB-502 and HB-501 alternating 2-vector therapy at Dose Level 1 OR placebo every 8 weeks for 24 weeks (injections at Weeks 0, 8, 16, and 24). **Intervention Names:** - Biological: HB-502 and HB-501 alternating 2-vector therapy Dose Level 1 - Other: Placebo **Label:** HB-502 and HB-501 alternating 2-vector therapy (Dose Level 1) OR placebo **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Intramuscular injection of HB-502 and HB-501 alternating 2-vector therapy at Dose Level 2 OR placebo every 8 weeks for 24 weeks (injections at Weeks 0, 8, 16, and 24). **Intervention Names:** - Biological: HB-502 and HB-501 alternating 2-vector therapy Dose Level 2 - Other: Placebo **Label:** HB-502 and HB-501 alternating 2-vector therapy (Dose Level 2) OR placebo **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - HB-502 and HB-501 alternating 2-vector therapy (Dose Level 1) OR placebo **Description:** Administration of HB-502 and HB-501 alternating 2-vector therapy to 10 participants. **Name:** HB-502 and HB-501 alternating 2-vector therapy Dose Level 1 **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - HB-502 and HB-501 alternating 2-vector therapy (Dose Level 2) OR placebo **Description:** Administration of HB-502 and HB-501 alternating 2-vector therapy to 10 participants. **Name:** HB-502 and HB-501 alternating 2-vector therapy Dose Level 2 **Type:** BIOLOGICAL #### Intervention 3 **Arm Group Labels:** - HB-502 and HB-501 alternating 2-vector therapy (Dose Level 1) OR placebo - HB-502 and HB-501 alternating 2-vector therapy (Dose Level 2) OR placebo **Description:** Administration of placebo to 5 participants. **Name:** Placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Assess the safety of HB-502 and HB-501 alternating 2-vector therapy compared with placebo by monitoring the type, frequency, and severity of unsolicited treatment-emergent and serious AEs, using the Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric AEs, Corrected Version 2.1, July 2017. **Measure:** Number of participants with adverse events (AEs) **Time Frame:** From first dosing until 48 weeks after first dosing **Description:** Assess the frequency and type of solicited local injection site reactions in response to HB-502 and HB-501 alternating 2-vector therapy compared with placebo, using the DAIDS Table for Grading the Severity of Adult and Pediatric AEs, Corrected Version 2.1, July 2017. **Measure:** Number of participants with local injection site reactions **Time Frame:** From first dosing until 48 weeks after first dosing **Description:** Assess the frequency and type of solicited systemic reactogenicity events in response to HB-502 and HB-501 alternating 2-vector therapy compared with placebo, using the DAIDS Table for Grading the Severity of Adult and Pediatric AEs, Corrected Version 2.1, July 2017. **Measure:** Number of participants with systemic reactogenicity events **Time Frame:** From first dosing until 48 weeks after first dosing #### Secondary Outcomes **Description:** Assess changes from baseline in the magnitude of T cell response specific to the transgenes harbored in HB-502 and HB-501. **Measure:** Determine the magnitude of the cellular immune response against HIV-1 induced by HB-502 and HB-501 alternating 2-vector therapy compared with placebo **Time Frame:** From first dosing until 48 weeks after first dosing **Description:** Assess changes from baseline in the breadth of T cell responses to the different transgenes harbored in HB-502 and HB-501. **Measure:** Determine the breadth of the cellular immune response against HIV-1 induced by HB-502 and HB-501 alternating 2-vector therapy compared with placebo **Time Frame:** From first dosing until 48 weeks after first dosing ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participants 18 to 65 years of age. * Confirmed HIV infection as documented by medical records or confirmatory HIV testing at screening. * Must be on stable suppressive antiretroviral treatment (ART) for at least 48 weeks prior to screening. * Must have plasma HIV RNA levels of \<50 copies/mL (or lower limit of quantitation) for at least 48 weeks prior to enrollment. * Must have a cluster of differentiation (CD)4+ cell count \>450 cells/mm3 and CD4+ cell % of ≥15% obtained within 40 days prior to enrollment. * Is in good general health according to the clinical judgment of the site Investigator. Exclusion Criteria: * History of hypersensitivity or other contraindication to any of the components of the study interventions as determined by the Investigator. * HIV-associated malignancy according to the National Cancer Institute (including Kaposi's sarcoma), and any type of lymphoma or virus-associated cancers. * History of HIV-associated neurocognitive disease or progressive multifocal leukoencephalopathy. * More than stage 2 HIV-related illness based on the Revised Surveillance Case Definition for HIV Infection (CDC 2014). * Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery within 156 weeks (i.e., 3 years) prior to enrollment. * Known history of hepatitis B virus (defined as hepatitis B surface antigen reactive) or known active hepatitis C virus infection (defined as hepatitis C virus RNA is detected \[qualitative\]). * Current untreated or incompletely treated active TB disease or untreated latent TB infection. * Has any serious or uncontrolled medical disorder that, in the opinion of the Investigator, may increase the risk associated with study participation or study treatment administration, impair the ability of the participant to receive study treatment, or interfere with the interpretation of the study results. * Is a previous or current recipient of an investigational HIV vaccine (previous placebo/control recipients are not excluded). * Received non-HIV experimental vaccine(s) within the last 1 year. * Has congenital or acquired immunodeficiency, including systemic medication use likely to impair immune response to vaccine in the opinion of the site Investigator, such as history of systemic corticosteroids (long-term use), immunosuppressive anti-cancer or other immunosuppressive agents, interleukins, systemic interferons, systemic chemotherapy, or other medications considered significant by the Investigator within 24 weeks prior to the start of study therapy. * Received blood products or immunoglobulin within 16 weeks prior to enrollment. * Received systemic steroids at a dose of ≥10 mg/day (prednisone equivalent) for \<30 within 14 days or for ≥30 days within 28 days of first dose of study treatment. * Received any vaccine within 4 weeks prior to enrollment. * Initiated antigen-based immunotherapy for allergies within the previous year (stable immunotherapy is not exclusionary). * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or contraindicate participation in this study, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator. * Is pregnant or breastfeeding or expecting to conceive or father children starting with the screening visit through a minimum of 12 weeks after the last dose of trial treatment. **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:** General Hookipa Contact **Phone:** +1 240-367-5320 **Role:** CONTACT #### Locations **Location 1:** **City:** Boston **Country:** United States **Facility:** Beth Israel Deaconness Medical Center **State:** Massachusetts **Zip:** 02215 #### Overall Officials **Official 1:** **Affiliation:** Hookipa Biotech GmbH **Name:** Head of Clinical Development **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007154 - Term: Immune System Diseases - ID: D000086982 - Term: Blood-Borne Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000007239 - Term: Infections - ID: D000015229 - Term: Sexually Transmitted Diseases, Viral - ID: D000012749 - Term: Sexually Transmitted Diseases - ID: D000016180 - Term: Lentivirus Infections - ID: D000012192 - Term: Retroviridae Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000014777 - Term: Virus Diseases - ID: D000012897 - Term: Slow Virus Diseases - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M18250 - Name: HIV Infections - Relevance: HIGH - As Found: Human Immunodeficiency Virus (HIV) Infection - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M3522 - Name: Acquired Immunodeficiency Syndrome - Relevance: HIGH - As Found: Human Immunodeficiency Virus (HIV) Infection - ID: M10199 - Name: Immunologic Deficiency Syndromes - Relevance: HIGH - As Found: Immunodeficiency - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M2593 - Name: Blood-Borne Infections - Relevance: LOW - As Found: Unknown - ID: M15558 - Name: Sexually Transmitted Diseases - Relevance: LOW - As Found: Unknown - ID: M17933 - Name: Sexually Transmitted Diseases, Viral - Relevance: LOW - As Found: Unknown - ID: M18640 - Name: Lentivirus Infections - Relevance: LOW - As Found: Unknown - ID: M15026 - Name: Retroviridae Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M15700 - Name: Slow Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000163 - Term: Acquired Immunodeficiency Syndrome - ID: D000015658 - Term: HIV Infections - ID: D000007153 - Term: Immunologic Deficiency Syndromes ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M17360 - Name: Vaccines - Relevance: LOW - As Found: Unknown - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: M25428 - Name: Anti-Retroviral Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430892 **Brief Title:** RAPID-POP a Randomized Controlled Trial **Official Title:** Efficacy of the Pressure Optimization Protocol (POP )Versus Conventional Stent Deployment Strategy During Primary Percutaneous Coronary Intervention. #### Organization Study ID Info **ID:** IRB-23/2024 #### Organization **Class:** OTHER **Full Name:** National Institute of Cardiovascular Diseases, Pakistan ### Status Module #### Completion Date **Date:** 2024-11 **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:** 2024-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** National Institute of Cardiovascular Diseases, Pakistan #### Responsible Party **Investigator Affiliation:** National Institute of Cardiovascular Diseases, Pakistan **Investigator Full Name:** Professor Abdul Hakeem **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:** Efficacy of the Pressure Optimization Protocol (POP) versus Conventional Stent Deployment Strategy during Primary PCI: An Open Label Randomized Clinical Trial The investigators will compare conventional rapid stent inflation/deflation during primary PCI with higher pressure and prolonged duration of stent deployment Study Hypothesis: The POP in stent deployment is superior to the conventional stent deployment approach with a significantly higher achievement of the TIMI III flow, significantly lesser occurrence of slow flow/no-reflow, and significantly higher rate of ST-Segment resolution during primary PCI. **Detailed Description:** Primary Objective The primary objective is to compare the rate of TIMI III flow achievement, slow flow/no-reflow, and ST-segment resolution between POP versus conventional stent deployment strategy during Primary PCI. Secondary Objective The secondary objective is in-hospital outcome (to compare the rate of major adverse cardiovascular events (MACE) during hospitalization between POP versus conventional stent deployment strategy during Primary PCI.) Material and Methods Study design: An open-label randomized controlled trial (RCT) with blinded outcome assessment Setting: Cath Lab NICVD Karachi ,Hyderabad and Sukkur Duration of study: 6 months Stent Deployment Protocol: Patients will be randomly assigned to either POP or conventional stent deployment approach groups in 1:1 ratio using the block randomization method. SAMPLE SIZE : 400 patients will be randomized into 2 groups with 1:1 Concealment: Allocation schema will remain accessible to the randomization and allocation team and will be communicated to the screening and recruitment team on a patient-on-patient basis. Blinding: This will be an open-label study, however, the outcome assessment will be blinded. A de-identified CD and post-PCI ECG with a unique tracking ID will be evaluated by the team of independent consultants, who will be blinded to the stent placement approach, and primary outcome variables i.e. TIMI flow, slow-flow/no-reflow, and ST-segment resolution will be assessed. Immediately post-procedure, a de-identified CD and post-PCI ECG with a unique tracking ID will be evaluated by the team of independent consultants, who will be blinded to the stent placement approach, and primary outcome variables i.e. TIMI flow, slow-flow/no-reflow, and ST-segment resolution will be assessed. All the patients will be followed at 30 days and incidence of MACE will be recorded. In order to ensure the integrity and reliability of the data, all procedures and imaging assessments will be carried out by clinicians and technicians trained and standardized in the respective methodologies. Moreover, data will be stored in a secure, electronic database with restricted access to maintain patient confidentiality and data security. Regular data audits will be conducted to ensure accuracy and consistency throughout the trial. Data Analysis: Firstly, patient demographics and baseline clinical characteristics will be summarized using means and standard deviations for continuous variables and frequencies with percentages for categorical variables. Kaplan-Meier survival analysis will be used to determine the time-to-event data for outcomes such as target vessel failure, target vessel revascularization, cardiac death, and myocardial infarction. Log-rank tests will be employed to compare survival curves between the POP and Rapid I/D groups. Cox proportional hazards models will be used to compute hazard ratios (HRs) and their 95% confidence intervals (CIs) for each outcome of interest, adjusting for potential confounders. For categorical outcomes, chi-squared tests or Fisher's exact tests will be used, as appropriate. Continuous outcomes will be assessed using t-tests or Mann-Whitney U tests based on data distribution. Any unmatched or imbalanced variables between the two groups will be controlled using propensity score matching. To address potential confounding factors and biases, a sensitivity analysis will be performed. Lastly, all statistical analyses will be two-tailed, with a significance level set at p \< 0.05. Statistical software such as SPSS or R will be utilized for the analysis. ### Conditions Module **Conditions:** - Myocardial Infarction, Acute ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Participants will be randomized into two groups in 1:1 , one arm will be treated with POP protocol and the other arm will be treated with conventional method. ##### Masking Info **Masking:** SINGLE **Masking Description:** This will be an open-label study, however, the outcome assessment will be blinded. A de-identified CD and post-PCI ECG with a unique tracking ID will be evaluated by the team of independent consultants, who will be blinded to the stent placement approach, and primary outcome variables i.e. TIMI flow, slow-flow/no-reflow, and ST-segment resolution will be assessed **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 400 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients in this arm will be treated according to the POP protocol for stent deployment **Intervention Names:** - Procedure: Primary Percutaneous Coronary Intervention (PPCI) **Label:** POP Protocol **Type:** OTHER #### Arm Group 2 **Description:** Patients in this arm will be treated with conventional method (rapid inflation-deflation protocol) for stent deployment **Intervention Names:** - Procedure: Primary Percutaneous Coronary Intervention (PPCI) **Label:** Conventional method **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Conventional method - POP Protocol **Description:** Patients presented with acute myocardial infarction undergoing primary percutaneous coronary intervention with stent deployment **Name:** Primary Percutaneous Coronary Intervention (PPCI) **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** To assess flow in the vessel after deployment of stent **Measure:** TIMI III flow: TIMI III flow is defined as normal flow with complete filling of the distal vascular bed. **Time Frame:** periprocedurally (after stent deployment) **Description:** To assess is there any Slow-flow/no-reflow phenomenon , which is TIMI flow grade \< 3 and as myocardial blushing grade (MBG) \< 2. **Measure:** Slow-flow/no-reflow **Time Frame:** periprocedurally (after stent deployment) **Description:** Assessment of ST-segment resolution , The electrocardiographic resolution of the ST-segment elevation is defined as a reduction of \> 50% of the ST-segment elevation in the same lead within 60 min after the index procedure **Measure:** ST-segment resolution **Time Frame:** Time frame:60minutes after the procedure #### Secondary Outcomes **Description:** cardiovascular death **Measure:** Cardiovascular death ( CV death) **Time Frame:** Time frame: during hospitalization (in-hospital) **Description:** Myocardial infarction of different territory **Measure:** Myocardial infarction **Time Frame:** Time frame: during hospitalization (in-hospital) **Description:** same territory Myocardial infarction **Measure:** Stent thrombosis **Time Frame:** Time frame: during hospitalization (in-hospital) **Description:** Cerebrovascular events during hospital stay **Measure:** Cerebrovascular accident ( CVA /Stroke) **Time Frame:** Time frame: during hospitalization (in-hospital) **Description:** Significant arrhythmias requiring treatment **Measure:** Arrhythmias **Time Frame:** Time frame: during hospitalization (in-hospital) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients aged 18 years and above. * Patients undergoing primary percutaneous coronary intervention (PCI) with stent implantation. * Presence of significant coronary artery stenosis (greater than 70% diameter reduction) confirmed by angiography. Exclusion Criteria: * Patients with Killip class IV * Patients with significant comorbidities such as end-stage renal disease or advanced liver disease which may interfere with the procedure or follow-up. * Prior history of coronary artery bypass grafting (CABG). * Refusal to give consent for study participation or procedure **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Abdul Hakeem, professor **Phone:** +923355554342 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Shakir Zada, fellow **Phone:** +923469467449 **Role:** CONTACT #### Locations **Location 1:** **City:** Karachi **Contacts:** ***Contact 1:*** - **Name:** Shakir Zada, FELLOW - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 2:*** - **Name:** HAROON ISHAQ, AP - **Role:** SUB_INVESTIGATOR ***Contact 3:*** - **Name:** AYAZ MIR, AP - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** FAIZA FAROOQ, AP - **Role:** SUB_INVESTIGATOR ***Contact 5:*** - **Name:** ABDUL HAMEED, FELLOW - **Role:** SUB_INVESTIGATOR ***Contact 6:*** - **Name:** FARAZ MEMON, AP - **Role:** SUB_INVESTIGATOR ***Contact 7:*** - **Name:** HASSAN BUT, AP - **Role:** SUB_INVESTIGATOR ***Contact 8:*** - **Name:** CHANDAR PARKASH, AP - **Role:** SUB_INVESTIGATOR ***Contact 9:*** - **Name:** QAMAR ZAMAN, FELLOW - **Role:** SUB_INVESTIGATOR **Country:** Pakistan **Facility:** National institute of cardiovascular diseases **State:** Sindh **Status:** RECRUITING **Zip:** 75510 #### Overall Officials **Official 1:** **Affiliation:** National Institute of Cardiovascular Diseases, Pakistan **Name:** ABDUL HAKEEM, PROF **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## 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: 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: D000007238 - Term: Infarction ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430879 **Acronym:** POWER-UP **Brief Title:** Performance Output With Haptics - Evaluating Athlete Response and Unrealized Potential **Official Title:** POWER-UP Trial (Performance Output With Haptics - Evaluating Athlete Response and Unrealized Potential) #### Organization Study ID Info **ID:** POWER-UP 001 #### Organization **Class:** INDUSTRY **Full Name:** SuperPatch Limited LLC ### Status Module #### Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-10 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Arizona **Class:** UNKNOWN **Name:** Clarity Science LLC #### Lead Sponsor **Class:** INDUSTRY **Name:** SuperPatch Limited LLC #### 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 minimal risk, randomized, double-blind, placebo controlled Institutional Review Board (IRB)-approved observational study with functional measurements, will evaluate athletic performance after use of a drug- free, non-invasive patch (VICTORY Patch; The Super Patch Company Inc.); using KangaTech, Catapult and Force Plates along with crossover control of trials within the same subject group not receiving an 'active' patch. **Detailed Description:** Emerging technologies that use haptic (skin pressure) technology have been studied and have shown positive improvements in stress levels, balance, sleep, and pain. The VICTORY patch (SuperPatch Company, Toronto, Canada) that also incorporates this technology has shown anecdotal promise to improve athlete performance. With the tools currently in use at the University of Arizona, team coaches and physicians can measure the true impact of neuromuscular changes suggested by the VICTORY patch. This study will measure quadriceps and hamstring strength in isolation as well as peak output in jumping and speed testing within in season training programs with and without VICTORY patch use. When combined with new methods of assessing individual muscle strength (KangaTech) and Force plate as well as Catapult measurements of compound movements of the investigational muscles, the investigators can evaluate the true performance and changes in football athletes with the SuperPatch technology. ### Conditions Module **Conditions:** - Muscle Strength - Muscle Weakness **Keywords:** - muscle - quadriceps - hamstrings - college athletes - elite athletes - haptic technology - vibrotactile trigger technology - VTT - neuromuscular changes ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** Randomized, double-blind, placebo controlled, crossover trial with functional measurements ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Data will be collected for athletes prior to first use of patch and then 2-3 days later with the active patch (VICTORY PATCH). Follow-up functional measurements will also be taken at 7 and 9-10 days after baseline with second crossover patch use 9-10 days post-baseline. **Intervention Names:** - Device: VICTORY PATCH **Label:** Active/Treatment **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Data will be collected for athletes prior to first use of patch and then 2-3 days later with the inactive patch. Follow-up functional measurements will also be taken at 7 and 9-10 days after baseline with second crossover patch use 9-10 days post-baseline. **Intervention Names:** - Device: Sham Patch without VTT **Label:** Non-Active/Control **Type:** SHAM_COMPARATOR #### Arm Group 3 **Description:** Data will be collected for athletes prior to first use of patch and then 2-3 days later with the active or inactive patch. Follow-up functional measurements will also be taken at 7 and 9-10 days after baseline with second crossover patch use 9-10 days post-baseline. **Intervention Names:** - Device: VICTORY PATCH - Device: Sham Patch without VTT **Label:** Crossover **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Active/Treatment - Crossover **Description:** Drug- free, non-invasive patch (VICTORY Patch) with haptic vibrotactile trigger technology (VTT) **Name:** VICTORY PATCH **Other Names:** - Haptic Vibrotactile Trigger Technology - VTT **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Crossover - Non-Active/Control **Description:** Sham Patch without haptic vibrotactile trigger technology (VTT) **Name:** Sham Patch without VTT **Other Names:** - Sham Comparator **Type:** DEVICE ### Outcomes Module #### Other Outcomes **Description:** Evaluation of reported side effects during study period based on self-report by subject or reported by clinician investigator. **Measure:** Any side effects reported by patients with be documented in athletic training electronic medical record and assessed by team physician and PI **Time Frame:** 10 days #### Primary Outcomes **Description:** Evaluation of change in quadriceps and hamstring function via KangaTech measurements (mm/Kg) **Measure:** Changes in subject performance and strength and intensity/interference scores among and between the treated group and the control group for the athlete. **Time Frame:** 10 days **Description:** Evaluation of change in max power of the Ground Reaction Force (GRF) in quadriceps and hamstring function measured by the Vald force plate (F = m \* a ; 1 m/s2). **Measure:** Changes in subject performance and strength and intensity/interference scores among and between the treated group and the control group for the athlete. **Time Frame:** 10 days **Description:** Evaluation of of Catapult Global Positioning System (GPS) and change in quadriceps and hamstring function to capture maximum acceleration and maximum speed (meters per second (m/s)) during their field workout. **Measure:** Changes in subject performance and strength and intensity/interference scores among and between the treated group and the control group for the athlete. **Time Frame:** 10 days **Description:** Evaluation of change in subject response to The Borg Rating of Perceived Exertion (RPE) (scale= 1- 10) **Measure:** Changes in subject performance and strength and intensity/interference scores among and between the treated group and the control group for the athlete. **Time Frame:** 10 days **Description:** Evaluation of performance (overall scores) based on concentration of patch placement among study subjects on either dominant medial forearm or dominant side, or mid-anterior thigh. **Measure:** Changes in performance based on patch location or playing position with the VICTORY Patch treatment. **Time Frame:** 10 days #### Secondary Outcomes **Description:** Evaluation of predictive baseline metrics of playing position and predictive modeling will be used to identify subject phenotype(s) with an optimal, and a least positive, response. The data used as inputs to construct the predictive models will be a collection of the survey results collected from patients at day 0. Optimal and least positive responses will be defined based on changes in performance and other functional measurement scores, and changes in concomitant medications used, in the treatment group between survey dates. **Measure:** Identification of subject phenotype(s) that will have the optimal response to treatment with the VICTORY Patch, as well as athletes having the least positive response. **Time Frame:** 10 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Adults 18 to 30, inclusive 2. Able to provide written informed consent 3. Have received a VICTORY Patch if in treatment group. 4. Is an athlete on a University of Arizona Varsity Athletic Team 5. Agree to having physical activity objectively measured for physical activity, as well as attendance, and participation in intervention. 6. Agree to place an adhesive patch on their skin, as instructed, based on selection group. Exclusion Criteria: 1. Use of drugs of abuse (illicit or prescription) 2. Have an implanted device, or wears, or adheres any electrical device to the body during the study, other than a hearing aid. 3. Any current medical or musculoskeletal injury that would prohibit athletic participation 4. Any significant injuries in the last month prior to the intervention that may impact tested performance measures. 5. New injuries that occur during the course of study testing that may impact performance measures. **Healthy Volunteers:** True **Maximum Age:** 30 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Peter Hurwitz **Phone:** 9177570521 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** University of Arizona **Name:** Mark Sakr, DO **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000020879 - Term: Neuromuscular Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M20944 - Name: Muscle Weakness - Relevance: HIGH - As Found: Muscle Weakness - ID: M4554 - Name: Asthenia - Relevance: LOW - As Found: Unknown - ID: M13204 - Name: Paresis - Relevance: LOW - As Found: Unknown - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M22619 - Name: Neuromuscular Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000018908 - Term: Muscle Weakness ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430866 **Acronym:** Eucalyptus **Brief Title:** Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab) **Official Title:** A Randomized, Double-blind Study to Compare the Pharmacokinetics Between ABP 234 and Keytruda® (Pembrolizumab) in Participants With Early-stage Non-squamous Non-small Cell Lung Cancer as Adjuvant Treatment Following Resection and Platinum-based Chemotherapy #### Organization Study ID Info **ID:** 20230127 #### Organization **Class:** INDUSTRY **Full Name:** Amgen ### Status Module #### Completion Date **Date:** 2026-10-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-04 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-17 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-03-15 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Amgen #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The primary objective of this study is to demonstrate pharmacokinetic (PK) similarity ABP 234 with pembrolizumab. ### Conditions Module **Conditions:** - Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC) **Keywords:** - NSCLC - Keytruda - Pembrolizumab - ABP 234 ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 154 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive ABP 234 every 3 weeks (Q3W) for up to 12 months. **Intervention Names:** - Drug: ABP 234 **Label:** ABP 234 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive pembrolizumab Q3W for up to 12 months. **Intervention Names:** - Drug: Pembrolizumab **Label:** Pembrolizumab **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - ABP 234 **Description:** Administered by intravenous (IV) injection. **Name:** ABP 234 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Pembrolizumab **Description:** Administered by IV injection. **Name:** Pembrolizumab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Area Under the Serum Concentration-time Curve (AUC) From Time 0 to 21 Days (AUC21d) Following the First Dose **Time Frame:** 21 days **Measure:** AUC at Steady State Between Week 16 and Week 19 (AUCtau_ss) **Time Frame:** Weeks 16-19 #### Secondary Outcomes **Measure:** Maximum Observed Serum Concentration (Cmax) Following the First Dose (Cmax_dose1) **Time Frame:** Up to 65 weeks **Measure:** Time to Maximum Serum Concentration (Tmax) Following the First Dose (Tmax_dose1) **Time Frame:** Up to 65 weeks **Measure:** Cmax at Steady State (Cmax_ss) **Time Frame:** Weeks 16-19 **Measure:** Tmax at Steady State (Tmax_ss) **Time Frame:** Weeks 16-19 **Measure:** Trough Serum Concentrations (Ctrough) at Pre-dose of Week 4 (Ctrough_w4) **Time Frame:** Week 4 pre-dose **Measure:** Ctrough at Stead State (Ctrough_ss) **Time Frame:** Weeks 16 and 19 pre-dose **Measure:** Number of Participants with Treatment-emergent Adverse Events **Time Frame:** Up to 16 months **Measure:** Number of Participants with Treatment-emergent Serious Adverse Events **Time Frame:** Up to 16 months **Measure:** Number of Participants with Treatment-emergent Adverse Events of Interest (EOIs) **Time Frame:** Up to 16 months **Measure:** Number of Participants with Andit-drug Antibodies **Time Frame:** Baseline and weeks 4, 7, 16, 19, 22, 28, 40, 52, and 65 **Measure:** Disease-free Survival **Time Frame:** Up to 65 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Males and females ≥ 18 years of age. * Pathological diagnosis of non-squamous NSCLC. * Stage IB (T2 ≥ 4 cm), II, or IIIA NSCLC after complete surgical resection and received platinum-based chemotherapy. * For programmed death-ligand 1 (PD-L1) testing, tumor tissue from the resected site of disease must be sent, received, and analyzed for biomarkers. * Treated with platinum-based chemotherapy: 1. Chemotherapy must have begun within 12 weeks after the resection surgery. 2. The last chemotherapy dose must have been completed at least 3 weeks and no more than 12 weeks before the participant is randomized. * Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1. * Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and ROS-1 negative. * Have adequate organ function as indicated by laboratory values. * Absence of severe comorbidities that in the opinion of the investigator might hamper participation in the study and/or treatment administration. * Participants must sign approved informed consent form (ICF). Exclusion Criteria: * Evidence of disease. * Prior treatment with anti-programmed cell death protein 1 and anti-PD-L1/2 modulating agents in adjuvant setting. * History or presence of immune-mediated disorders. * Participants with type 1 diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders not requiring systemic treatment are permitted to enroll. * Participant has positive screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C (HCV). * Medical conditions requiring systemic immunosuppression. * History of any other malignancy other than NSCLC within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, papillary thyroid cancer treated with surgery, etc. * Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis virus, current alcohol abuse or cirrhosis. * Surgery or chemotherapy-related toxicity not resolved to grade 1 with the exception of grade ≤ 2 alopecia, fatigue, neuropathy, and lack of appetite/nausea. * Woman of childbearing potential who is pregnant or is breast feeding. * Woman of childbearing potential who is not consenting to use highly effective methods of birth control. * Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control. * Participant has known hypersensitivity to monoclonal antibodies or to any of the excipients of the investigational product (IP). * Active cardiac disease or history of cardiac dysfunction, that in the judgment of the investigator would place the participant at additional risk when participating in the study. * Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current neumonitis/interstitial lung disease. * Live vaccine therapy within 4 weeks prior to IP administration. * Participation in another investigational drug study within 30 days prior to IP administration. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Amgen Call Center **Phone:** 866-572-6436 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Amgen **Name:** MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below. **Description:** De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES **Time Frame:** Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study. **URL:** http://www.amgen.com/datasharing ### References Module #### See Also Links **Label:** AmgenTrials clinical trials website **URL:** http://www.amgentrials.com ## 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 ### 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: Non-Small Cell Lung Cancer - 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 ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000082082 - Term: Immune Checkpoint Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M349416 - Name: Pembrolizumab - Relevance: HIGH - As Found: Mg/m2 - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000582435 - Term: Pembrolizumab ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430853 **Acronym:** PIP **Brief Title:** Psychobiological Interventions in Pregnancy **Official Title:** Psychobiological Effects of Lifestyle Interventions in Pregnancy #### Organization Study ID Info **ID:** IRB-74741 #### Organization **Class:** OTHER **Full Name:** Stanford University ### Status Module #### Completion Date **Date:** 2027-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-09 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) #### Lead Sponsor **Class:** OTHER **Name:** Stanford University #### Responsible Party **Investigator Affiliation:** Stanford University **Investigator Full Name:** Danielle Panelli **Investigator Title:** Instructor of Obstetrics and Gynecology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This randomized control trial will evaluate whether a physical activity intervention can improve mental health and biologic markers of stress in pregnant people with depressive or anxiety symptoms. The study will enroll participants if they are presenting for prenatal care at Stanford Children's Health Obstetrics Clinic with a singleton gestation. ### Conditions Module **Conditions:** - Pregnancy Complications - Mental Health Issue - Depression, Anxiety - Pregnancy, High Risk - Biological Clock Disturbance **Keywords:** - Pregnancy - Stress - Mental health - Depression - Anxiety - Telomeres - Cortisol - Physical activity - Exercise ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 88 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will wear an Actigraph accelerometer watch, but not be given a step count goal, between 20 and 37 weeks of gestation. They will receive monthly text reminders to wear their watch as much as possible. **Intervention Names:** - Device: Actigraph watch **Label:** Usual step count **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** Participants will be given a daily step count goal of 9,000 steps per day based on the Actigraph watch, between 20 and 37 weeks of gestation. They will receive monthly text reminders reminding them of the step count goal and offering ways to achieve this goal. **Intervention Names:** - Behavioral: Step count goal - Device: Actigraph watch **Label:** Step count goal **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Step count goal **Description:** The step count goal will be discussed at the beginning of the study, and participants will be able to see their step count on the Actigraph watch to facilitate achieving this goal. All participants will receive monthly reminders that are tailored for their intervention arm. **Name:** Step count goal **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Step count goal - Usual step count **Description:** Both groups will wear the watch. Adherence will be assessed via step counts from accelerometer watch. **Name:** Actigraph watch **Other Names:** - Actigraph GT9X Link Accelerometer **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The mean within person change in EPDS score between randomization and the end of the study will be compared between the 2 arms. The EPDS is a 10-question validated measure with a score range of 0-30 for depression and/or anxiety screening in pregnancy that has been translated into many languages. A score of \>=10 has been shown to be consistent with depressive symptoms. **Measure:** Change in Edinburgh Postpartum Depression Scale (EPDS) Score **Time Frame:** Randomization around 20 weeks gestation and end of study (around 37 weeks gestation). #### Secondary Outcomes **Description:** The mean within person change in Edinburgh Postpartum Depression Anxiety Subscale score between randomization and the end of the study will be compared between the 2 arms. The three-question anxiety subscale on the EPDS (EPDS 3A) has a score range between 0-9, and a score \>=5 has been shown to be consistent with anxiety symptoms. **Measure:** Change in EPDS Anxiety Subscale Score **Time Frame:** Randomization around 20 weeks gestation and end of study (around 37 weeks) **Description:** Mean within person change in STAI score between randomization and the end of the study will be compared between the 2 arms. The STAI is 40 questions, and the score ranges from 40 to 160. A STAI score \>=80 has been shown to be consistent with anxiety symptoms. **Measure:** Change in State-Trait Anxiety Inventory (STAI) Score **Time Frame:** Randomization around 20 weeks gestation and end of study (around 37 weeks) **Description:** Maternal leukocyte telomere length will be measured from saliva samples and analyzed via quantitative PCR. Mean within-person change in leukocyte telomere length will be compared between the two arms. **Measure:** Change in leukocyte telomere length **Time Frame:** Randomization around 20 weeks and end of study (around 37 weeks) **Description:** Maternal hair cortisol level will be measured from consecutive segments of hair strands. Mean within-person change in hair cortisol level will be compared between the two arms. **Measure:** Change in hair cortisol level **Time Frame:** Randomization around 20 weeks and end of study (around 37 weeks) **Description:** Frequency of pregnancy complications including hypertensive disorders, diabetes, fetal growth restriction, placental abruption, preterm birth, or stillbirth will be abstracted from the medical record **Measure:** Frequency of pregnancy complications **Time Frame:** 6 weeks postpartum **Description:** Frequency of neonatal complications including NICU admission, 5-minute Apgar \<7, low birthweight, need for mechanical ventilation, or neonatal demise will be abstracted from the medical record **Measure:** Frequency of neonatal complications **Time Frame:** 6 weeks postpartum ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Able to read and write in English or Spanish * Presenting for a prenatal visit with a viable singleton gestation (no known lethal fetal anomaly or plan for pregnancy termination) between 18 and 20 weeks 0 days * Any history of depression or anxiety, defined as: 1) documented depression or anxiety in the medical record within the preceding 2 years; 2) baseline EPDS score \>=10 at intake prenatal visit; 3) baseline EPDS anxiety subscale 3A score \>=5 Exclusion Criteria: * Known allergy to steel or rubber * Contraindication to physical activity such as a pre-existing cardiovascular condition or arrhythmia * Plan to relocate and/or deliver at another institution * Concurrent severe mental illness (diagnosis of bipolar disorder or schizophrenia) **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Stanford **Country:** United States **Facility:** Stanford University **State:** California **Zip:** 94305 #### Overall Officials **Official 1:** **Affiliation:** Stanford University **Name:** Danielle M Panelli, MD, MS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M14127 - Name: Pregnancy Complications - Relevance: HIGH - As Found: Pregnancy Complications - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M22703 - Name: Chronobiology Disorders - Relevance: HIGH - As Found: Biological Clock Disturbance - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000021081 - Term: Chronobiology Disorders - ID: D000011248 - Term: Pregnancy Complications - ID: D000003863 - Term: Depression ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M9912 - Name: Hydrocortisone - Relevance: LOW - As Found: Unknown - ID: M155245 - Name: Hydrocortisone 17-butyrate 21-propionate - Relevance: LOW - As Found: Unknown - ID: M228609 - Name: Hydrocortisone acetate - Relevance: LOW - As Found: Unknown - ID: M263259 - Name: Hydrocortisone hemisuccinate - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430840 **Acronym:** CAN-ASSIST **Brief Title:** Addressing Financial and Social Needs Among Patients With Cancer **Official Title:** Addressing Financial and Social Needs Among Patients With Cancer #### Organization Study ID Info **ID:** UCI-24-28 #### Organization **Class:** OTHER **Full Name:** University of California, Irvine #### Secondary ID Infos **Domain:** University of California Irvine IRB **ID:** 4937 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2026-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-10-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Chao Family Comprehensive Cancer Center #### Lead Sponsor **Class:** OTHER **Name:** University of California, Irvine #### Responsible Party **Investigator Affiliation:** University of California, Irvine **Investigator Full Name:** Gelareh Sadigh **Investigator Title:** Associate Professor In Residence **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Financial hardship and health-related social needs (e.g., insecurity about food, housing, transportation, utilities) are common among patients with cancer, resulting in health disparities in cancer outcomes. Our study will test the efficacy of a multicomponent financial navigation and counseling program delivered by a financial navigator (CostCOM), vs. direct patient access to financial education materials and comprehensive list of local resources in the absence of a financial navigator (FinEd) vs. practice usual care among newly diagnosed cancer patients who screen positive for financial hardship and social needs. Investigators anticipate that both CostCOM and FinEd compared to enhanced usual care will improve cost-related cancer care nonadherence, financial worry, health insurance literacy, quality of life and sleep quality and decrease number of missed appointments. **Detailed Description:** Financial hardship and health-related social needs (HRSNs) (e.g., insecurity about food, housing, transportation, and utilities) are common among patients with cancer, resulting in health disparities in cancer outcomes. Addressing financial hardship and HRSNs can mitigate their damaging health effects, yet screening for them is not the standard clinical practice. There is compelling evidence that out-of-pocket cost (OOPC) communication complemented by financial navigation and counseling delivered by a financial navigator (CostCOM intervention) will decrease financial hardship. However, implementation of this intervention is limited given shortage of financial navigators in many cancer centers. There is also evidence that patients with financial hardship have lower financial health literacy and financial self-efficacy. However, it is not clear whether direct access to local community or national resources and financial education (FinEd intervention) in the absence of financial navigators will meet patient's needs. Investigators propose a 3-arm pilot randomized controlled trial to assess potential efficacy differences in adherence, financial hardship, financial health literacy, quality of life, and sleep between CostCOM vs. FinEd vs. enhanced usual care (EUC) among 90 newly diagnosed cancer patients (1:1 non-metastatic vs. metastatic) who receive systemic or radiation therapy and are screened positive for financial and social needs. Our multidisciplinary team has experience with all facets of the proposed intervention. CostCOM patients will participate in two remote counseling sessions at baseline, and 3 months, and will receive (1) OOPC communication, individualized, patient-specific education of the anticipated medication OOPC; (2) Financial navigation, real-time professional guidance to identify financial assistance programs that will alleviate costs of care and discuss information to improve insurance coverage; and (3) Financial counseling to address the range of patients' financial concerns and enroll patients in financial assistance programs. FinEd patients will receive (1) a comprehensive list of local and national resources where patients can self-refer for financial and social needs; and (2) online and paper financial educational materials on topics such as health insurance and health insurance literacy, and navigating price estimator tools. EUC patients will receive usual care enhanced by screening for financial and social needs. Our goals are to compare the efficacy of CostCOM vs. FinEd vs. EUC at 6 months on (1) patient-reported cost-related cancer care nonadherence (defined as self-reported delay, forgo, stop or change in cancer care due to cost concerns), treatment completion and missed appointments (as obtained via medical record); (2) patient-reported financial worry, material hardship, health insurance literacy, and quality of life; and (3) patient-reported and objectively measured sleep quality using a sleep monitor. The study will support feasibility for a larger trial, and reveal efficacy estimates for potential CostCOM vs. FinEd differences in improving cancer patients' outcomes and approaches for incorporation into routine clinical practice. ### Conditions Module **Conditions:** - Cancer - Financial Hardship **Keywords:** - Sleep - Cancer - Financial Hardship - financial education - financial navigation - cost communication ### 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:** 90 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Usual care + pre-screening for financial hardship and social risks **Intervention Names:** - Other: Usual care - Other: Screening for financial and social needs **Label:** Arm A: Enhanced Usual Care (EUC) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Usual care + two 1-hour phone or video sessions with a remote financial counselor including out-of-pocket cost communication, financial navigation and counseling. **Intervention Names:** - Behavioral: CostCOM (Cost Communication, Financial navigation and counseling) - Other: Usual care - Other: Screening for financial and social needs **Label:** Arm B: CostCOM **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Usual care + access to local and national resources including (1) a detailed list of local and national resources for financial navigation, and social needs where patients can self-refer and (2) video and online /printed educational materials to improve financial health literacy **Intervention Names:** - Behavioral: Provision of local and national resources to address financial and social needs - Behavioral: Financial Education - Other: Usual care - Other: Screening for financial and social needs **Label:** Arm C: FinEd **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Arm B: CostCOM **Description:** Patients will receive two 1-hour, phone or video sessions with a remote financial counselor, each session will cover each of these 3 components of CostCOM. Out-of-pocket cost communication (OOPC): A review of insurance benefits and education of the patient-specific OOPC for anticipated treatment regimen if any (i.e., medication). The OOPC is provided as a total estimate and will be updated at 3-month session in case of changes in treatment or insurance. Financial navigation: Real-time professional guidance to identify financial assistance programs (e.g., co-pay, living expenses) that alleviate costs of care and discuss information to improve insurance coverage. Financial counseling: To address the range of patients' financial concerns and enroll patients in financial assistance programs. **Name:** CostCOM (Cost Communication, Financial navigation and counseling) **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Arm C: FinEd **Description:** Patients will be provided with a comprehensive list of local resources (in patients' preferred language) in Orange County that can help with food insecurity, ir transportation, as well as contact information for national non-profit organization where patients can self-refer for financial navigation (e.g., Patient Advocate Foundation (PAF) **Name:** Provision of local and national resources to address financial and social needs **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - Arm C: FinEd **Description:** Patient will receive online and paper educational materials on topics such as health insurance and health insurance literacy, navigating hospitals' price estimator tool. **Name:** Financial Education **Type:** BEHAVIORAL #### Intervention 4 **Arm Group Labels:** - Arm A: Enhanced Usual Care (EUC) - Arm B: CostCOM - Arm C: FinEd **Description:** Patients in all arms will receive usual care, which includes routine oncology visits, use of available ancillary staff, and internal or external resources for co-pay assistance or free medication per normal clinic procedures. **Name:** Usual care **Type:** OTHER #### Intervention 5 **Arm Group Labels:** - Arm A: Enhanced Usual Care (EUC) - Arm B: CostCOM - Arm C: FinEd **Description:** Patients will be screened for financial hardship and health-related social risks. **Name:** Screening for financial and social needs **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Patients experience and satisfaction with intervention components will be assessed through an interview process from a subset of patients of Arm C: FinEd. Results will be qualitatively measured. **Measure:** Patients' experience with intervention **Time Frame:** 6-8 months after randomization #### Primary Outcomes **Description:** Number of patients who report any incidence during the 6 months (measured at 3, and 6 months) when they self-reports a positive response to any of: (1) delay, (2) forego, (3) stop, or (4) change in cancer prescribed medication due to cost, (5) refuse recommended cancer tests, or (6) skip cancer office visits due to cost. **Measure:** Patients' Cost-Related Cancer Care Non-Adherence **Time Frame:** Within 6-months after randomization #### Secondary Outcomes **Description:** Number of patients who receive all the prescribed cycle of chemotherapy and/or radiation therapy due within the 6-month study period. **Measure:** Patients' Treatment Completion **Time Frame:** Within 6-months after randomization **Description:** Proportion of treatment appointments or office visits that is marked as cancellation or no show in the absence of chart note advising patient not to show up the appointment. **Measure:** Patients' Missed Appointments **Time Frame:** Within 6-months after randomization **Description:** Number of patients who report any incidence during the 6-months (measured 3, and 6 months) with a self-reported positive response to any of the following: (1) home sale, refinance or move to affordable rental, (2) loans, (3) reaching credit limits, and (4) bankruptcy) because of their cancer care, or its treatment **Measure:** Patients' Material Financial Hardship **Time Frame:** Within 6-months after randomization **Description:** Patients level of of financial worry regarding their cancer care will be measured using the Comprehensive Score for Financial Toxicity (COST) 11-item (score 0-44). Higher score= Lower financial worry **Measure:** Patients' Financial Worry **Time Frame:** Within 6-months after randomization **Description:** Patients level of health insurance literacy measured by 21 items Health Insurance Literacy Measure (Score range 21-84). Higher score= higher health insurance literacy **Measure:** Patients' Insurance Literacy **Time Frame:** Within 6-months after randomization **Description:** Quality of life will be measured using Patient-Reported Outcomes Measurement Information System (PROMIS)-10. T scores will be calculated ranging between 0-100. Higher score= higher quality of life. **Measure:** Patients' quality of life **Time Frame:** Within 6-months after randomization **Description:** Patients quality of sleep will be measured by an Insomnia Severity Index (ISI) that evaluates the severity of patients insomnia symptoms. (score 0-28). The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28). **Measure:** Patients' Sleep Quality (Subjective) **Time Frame:** Within 6-months after randomization **Description:** Patients total sleep time, sleep efficiency, nighttime awakening, and sleep latency, measured through a sleep ActiGraph **Measure:** Patients Sleep Quality (Objective) **Time Frame:** Within 6-months after randomization ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Speak English or Spanish * 18 years or older * Were diagnosed with any stage of cancer within the last 120 days * Getting treatment in University of California Irvine-affiliated oncology clinics * Have already started treatment like radiation, or cancer medication * Screen positive for financial hardship or health-related social needs Exclusion Criteria: * Patients with indolent cancer undergoing observation alone * Eastern Cooperative Oncology Group (ECOG) Performance status above 2 * Patients not receiving any cancer-directed therapy * Patients participating in other therapeutic clinical trials covering the cost of treatment. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Gelareh Sadigh **Phone:** 949-510-7925 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Richard J Echeverria **Phone:** 949-745-5066 **Role:** CONTACT #### Locations **Location 1:** **City:** Costa Mesa **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Omar Gutierrez - **Role:** CONTACT **Country:** United States **Facility:** UCI Health Cancer Center - Newport **State:** California **Zip:** 92627 **Location 2:** **City:** Orange **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Omar Gutierrez - **Role:** CONTACT **Country:** United States **Facility:** UCI Chao Family Comprehensive Cancer Center **State:** California **Zip:** 92868 **Location 3:** **City:** Yorba Linda **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Omar Gutierrez - **Role:** CONTACT **Country:** United States **Facility:** UCI Health - Yorba Linda **State:** California **Zip:** 92886 #### Overall Officials **Official 1:** **Affiliation:** University of California, Irvine **Name:** Gelareh Sadigh **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013315 - Term: Stress, Psychological - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M2567 - Name: Financial Stress - Relevance: HIGH - As Found: Financial Hardship - ID: M16105 - Name: Stress, Psychological - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000086522 - Term: Financial Stress ### Intervention Browse Module - Browse Branches - Abbrev: HB - Name: Herbal and Botanical - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T244 - Name: Orange - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430827 **Brief Title:** Clinical Study of Irinotecan Hydrochloride Liposome Combined With Capecitabine for Second-line Treatment in Patients With Advanced or Metastatic Biliary Tract Carcinoma **Official Title:** Clinical Study of Irinotecan Hydrochloride Liposome Injection Combined With Capecitabine for Second-line Treatment in Patients With Advanced or Metastatic Biliary Tract Carcinoma. #### Organization Study ID Info **ID:** CSPC-DNY-BTC-02 #### Organization **Class:** OTHER **Full Name:** Peking Union Medical College Hospital ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-04-15 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** CSPC Ouyi Pharmaceutical Co., Ltd. #### Lead Sponsor **Class:** OTHER **Name:** Ba Yi #### Responsible Party **Investigator Affiliation:** Peking Union Medical College Hospital **Investigator Full Name:** Ba Yi **Investigator Title:** Director **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** To evaluate the efficacy and safety of irinotecan hydrochloride liposome injection combined with Capecitabine for second-line treatment in Patients With advanced or metastatic biliary tract carcinoma. ### Conditions Module **Conditions:** - Biliary Tract Carcinoma ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will receive irinotecan hydrochloride liposome injection combined with Capecitabine therapy in a 2-week treatment cycle. **Intervention Names:** - Drug: irinotecan hydrochloride liposome injection - Drug: Capecitabine **Label:** Experimental **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental **Description:** rinotecan hydrochloride liposome injection (70mg/m\^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle. **Name:** irinotecan hydrochloride liposome injection **Other Names:** - duoenyi **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Experimental **Description:** Capecitabine (1000 mg/m\^2) will be administered orally in a 2-week treatment cycle, twice a day from day 1 to day 10 of each cycle **Name:** Capecitabine **Other Names:** - Kapeitabin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** To evaluate the efficacy of anti-tumor **Measure:** Progression-free survival (PFS) **Time Frame:** baseline up to approximately 6 months #### Secondary Outcomes **Description:** To evaluate the efficacy of anti-tumor **Measure:** Objective response rate (ORR) **Time Frame:** baseline up to approximately 6 months **Description:** To evaluate the efficacy of anti-tumor **Measure:** Overall survival (OS) **Time Frame:** baseline up to approximately 12 months **Description:** To identify the quality of life by QLQ-C30（V3.0） **Measure:** Quality of life (QoL) **Time Frame:** baseline up to approximately 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. The patient had good compliance, could understand the research process of this study, and signed a written informed consent. 2. Age ≥18 years. 3. Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer). 4. Subjects who had received gemcitabine prior first-line therapy and had not received fluorouracil drugs. 5. Subjects who have progressed after receiving previous first-line therapy, relapse within 6 months after the end of (neo) adjuvant therapy is considered as first-line therapy failure. 6. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1). 7. ECOG (Eastern Cooperative Oncology Group) performance status of 0-2. 8. Has a life expectancy of greater than 3 months. 9. LVEF≥50%. 10. Appropriate organ function is defined as follows: (Hematology and blood biochemistry tests must be completed within 14 days prior to enrollment, and the following criteria are met): 1. ANC ≥1.5×10\^9/L 2. Hb≥90g/L 3. PLT ≥100×10\^9/L 4. total bilirubin ≤1.5 x ULN 5. ALT/AST ≤ 2.5 x ULN; When there is liver metastasis, ALT/AST ≤ 5 x ULN 6. Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr) ≥50mL/min (according to Cockcroft-Gault fórmula) 7. Coagulation function: prothrombin time (PT), activated partial thromboplastin time (APTT) and international standardized ratio (INR) ≤1.5×ULN 11. Patients with biliary obstruction should receive adequate biliary drainage. 12. Adverse reactions caused by previous treatment must be restored to grade 1 or baseline according to CTCAE5.0 (except for toxicity such as alopecias, grade 2 and below peripheral neuropathy, which can be included after the investigator determines that there is no safety risk). 13. non-pregnant or lactating female; Effective contraception should be used by female/Male of childbearing age during the study period and for 6 months after the end of study treatment. 14. There were no contraindications for the use of irinotecan liposomes and capecitabine. Exclusion Criteria: 1. Patients who have had other malignant tumors within the previous 5 years (except cured carcinoma in situ and skin basal cell carcinoma). 2. Uncontrolled pleural effusion or ascites. 3. Any known brain or meningeal metastases. 4. Subjects were co-administering a potent CYP3A4 inducer within 3 weeks prior to first dosing, or a potent CYP3A4 inhibitor or a potent UGT1A1 inhibitor within 3 weeks prior to first dosing. 5. Subjects underwent large organ surgery (except needle biopsy, central venous catheterization, port catheterization, stenting for relief of biliary obstruction, percutaneous hepatobiliary drainage, and cholecystostomy) or an elective surgical program within 4 weeks before the first dose of the study drug. 6. Active, uncontrolled bacterial, viral, or fungal infections with systemic treatment, defined as persistent signs/symptoms associated with infection that do not go away despite the use of appropriate antibiotics, antiviral therapy, and/or other treatment, including patients with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). 7. Patients who are known to have dihydropyridine dehydrogenase (low activity) or deficiency. 8. There are serious concomitant diseases: such as uncontrolled diabetes after hypoglycemic drug treatment, uncontrolled hypertension, serious cardiovascular and cerebrovascular disease, kidney failure, liver failure, uncontrolled epilepsy, central nervous system disease or mental disorder history, clear gastrointestinal bleeding tendency, intestinal paralysis, intestinal obstruction, etc. 9. Grade 1 diarrhea with an increase in the number of stools \> 4 times per day compared to baseline; The moderate and severe effluents from stoma increased; Limited activities of daily living with the aid of tools or even self-rational activities of daily living; Life-threatening; Need urgent medical attention. 10. Had participated in other clinical investigators within 4 weeks before enrollment. 11. Unsuitable for participation in the trial by the investigator assessed. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yi Ba, PHD **Phone:** +86 010 69158705 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yi Ba, PHD - **Phone:** +86 010 69158705 - **Role:** CONTACT **Country:** China **Facility:** Peking Union Medicalcollege Hospital #### Overall Officials **Official 1:** **Affiliation:** PEKING UNION MEDICALCOLLEGE HOSPITAL **Name:** Yi Ba **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: 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 ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma ### 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: D000059004 - Term: Topoisomerase I Inhibitors - ID: D000059003 - Term: Topoisomerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M377 - Name: Capecitabine - Relevance: HIGH - As Found: Imaging - ID: M1671 - Name: Irinotecan - Relevance: HIGH - As Found: Emission - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown - ID: M29349 - Name: Topoisomerase I Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000069287 - Term: Capecitabine - ID: D000077146 - Term: Irinotecan ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430814 **Brief Title:** Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy **Official Title:** Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy #### Organization Study ID Info **ID:** AKF-403 #### Organization **Class:** OTHER **Full Name:** University of Southern Denmark ### Status Module #### Completion Date **Date:** 2026-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-09 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-04-25 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Odense University Hospital **Class:** OTHER **Name:** Sygehus Lillebaelt **Class:** UNKNOWN **Name:** Esbjerg Hospital **Class:** OTHER_GOV **Name:** Sonderborg Hospital #### Lead Sponsor **Class:** OTHER **Name:** University of Southern Denmark #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False ### Description Module **Brief Summary:** Investigation of which patients treated with paclitaxel have an increased risk of developing peripheral neuropathy. **Detailed Description:** The primary aim of this study is to validate the protein neurofilament light chain (NFL) as a biomarker of the side effect paclitaxel-induced peripheral neuropathy (PIPN) and its utility in predicting this side effect in patients with breast cancer. The investigators want to include 188 patients at four different trial sites. The patients must follow their normal treatment cycles while getting blood drawn during their treatment period however maximal 4 cycles. Blood samples are dawn before treatment initiation and once before each new cycle start in order to measure neurofilament light chain (NFL) before and during treatment. The investigators also want to take a skin biopsy before treatment start and after either cycle 3 or 4. The primary endpoint of the study is if serum NFL\>100 pg/ml after first cycle of paclitaxel can predict early termination of paclitaxel due to peripheral neuropathy. ### Conditions Module **Conditions:** - Chemotherapy-induced Peripheral Neuropathy ### Design Module #### Bio Spec **Description:** The investigators are taking blood samples to analyze the NFL level, paclitaxel concentration, and looking at DNA sequencing associated with PIPN. The investigators will also take skin biopsies to look at the nerve fiber density and if gene and protein expression of relevant genes changes following paclitaxel treatment. **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 188 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A total of 188 patients diagnosed with breast cancer who are scheduled for paclitaxel treatment, either as adjuvant or neo-adjuvant treatment, will be recruited across three trial sites. **Intervention Names:** - Other: No intervention **Label:** Breastcancer patients ### Interventions #### Intervention 1 **Arm Group Labels:** - Breastcancer patients **Description:** No intervention **Name:** No intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The primary endpoint of the study is if serum NFL\>100 pg/ml after first cycle (one cycle equals 3 weeks) of paclitaxel can predict early termination of paclitaxel due to peripheral neuropathy. **Measure:** NFL level correlation **Time Frame:** Before treatment start and during four cycles (one cycle equals 3 weeks) #### Secondary Outcomes **Description:** To measure if high concentration of paclitaxel exposure is correlated to high NFL level in blood **Measure:** Paclitaxel exposure **Time Frame:** Before treatment start and during four cycles (one cycle equals 3 weeks) **Description:** To measure if genetic variants in genes (e.g., CYP2C8\*3, EPHA4/5, FGD4) are associated with more server PIPN symptoms. **Measure:** Genes and PIPN **Time Frame:** Before treatment start and during four cycles (one cycle equals 3 weeks) **Description:** To measure if genetic variants in genes (e.g., CYP2C8\*3, EPHA4/5, FGD4) are associated with high NFL concentration in blood. **Measure:** Genes and NFL **Time Frame:** Before treatment start and during four cycles (one cycle equals 3 weeks) **Description:** To measure if genetic variants in genes (e.g., CYP2C8\*3, EPHA4/5, FGD4) are associated with high paclitaxel concentration in blood. **Measure:** Genes and Paclitaxel **Time Frame:** Before treatment start and during four cycles (one cycle equals 3 weeks) **Description:** Investigate if and which specific drug-drug interactions are correlated to developing PIPN. **Measure:** Drug-drug interactions **Time Frame:** Before treatment start and during four cycles (one cycle equals 3 weeks) **Description:** Obtain skin biopsies from patients to elucidate which molecular mechanisms and phenotypes are associated with PIPN. **Measure:** Skin biopsies **Time Frame:** Before treatment start and during four cycles (one cycle equals 3 weeks) **Description:** Obtain skin biopsies at baseline and at the beginning of cycle 3 or 4 (one cycle equals 3 weeks) to assess if the intraepidermal nerve fiber density (IENFD) changes during paclitaxel treatment. **Measure:** IENFD **Time Frame:** Before treatment start and during four cycles (one cycle equals 3 weeks) **Description:** To assess whether the patients who have a sensation of heat during cooling of the skin (PHS) are also those who experience neuropathic pain. **Measure:** PHS **Time Frame:** Before treatment start and during four cycles (one cycle equals 3 weeks) **Description:** To examine if increased NFL level is correlated to changes in small and large nerve fibers dysfunction. **Measure:** Nerve fiber dysfunction **Time Frame:** Before treatment start and during four cycles (one cycle equals 3 weeks) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age \> 18 years * Willing to give informed consent * Scheduled to receive neo-adjuvant or adjuvant paclitaxel treatment * Able to speak and understand Danish * Diagnosed with breast cancer * Paclitaxel naïve patients Exclusion Criteria: * Neurodegenerative diseases (e.g., neuropathy from another cause, previous apoplexy, disc herniation * Type 1 or 2 diabetes * Pregnant * Breastfeeding * Relapse of cancer diagnosis * Diagnosed with human immunodeficiency virus (HIV) * Participation in other clinical trials where the dose of paclitaxel is changed, or the aim is to prevent neuropathic pain or decrease NFL level (except if the intervention is to use cooling gloves). * Previous treatment with neurotoxic chemotherapy * Chronic pain from another cause * Metastatic cancer **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** A total of 188 patients diagnosed with breast cancer who are scheduled for paclitaxel treatment, either as adjuvant or neo-adjuvant treatment, will be recruited across four trial sites. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ditte Bork Iversen, MSc Pharm, PhD **Phone:** +45 65 50 23 52 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Tore B. Stage, Prof **Phone:** +45 65 50 36 78 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** University of Southern Denmark **Name:** Ditte Bork Iversen **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Description:** Data on individual participants is not allowed due to GDPR **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M13432 - Name: Peripheral Nervous System Diseases - Relevance: HIGH - As Found: Peripheral Neuropathy - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010523 - Term: Peripheral Nervous System Diseases ### 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 ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430801 **Brief Title:** A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008) **Official Title:** A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease #### Organization Study ID Info **ID:** 7240-008 #### Organization **Class:** INDUSTRY **Full Name:** Merck Sharp & Dohme LLC #### Secondary ID Infos **Domain:** Merck **ID:** MK-7240-008 **Type:** OTHER **Domain:** EU CT **ID:** 2023-508636-61 **Type:** REGISTRY **Domain:** UTN **ID:** U1111-1298-6080 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2029-09-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2029-09-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-11 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Merck Sharp & Dohme LLC #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. The primary hypotheses for Study 1 and Study 2 are that tulisokibart is superior to placebo in achieving the coprimary outcome measures of clinical remission by either Crohn's Disease Activity Index (CDAI, primary endpoint recommended by United States Food and Drug Administration \[US/FDA\]) or stool frequency and abdominal pain score (primary endpoint recommended by European Union European Medicines Agency \[EU/EMA\]) and endoscopic response. ### Conditions Module **Conditions:** - Crohn's Disease ### 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:** 1200 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants receive high dose induction of intravenous (IV) tulisokibart a total of 4 times on Day 1 and Weeks 2, 6, and 10. This is followed by a high dose maintenance of subcutaneous (SC) tulisokibart every 2 weeks (Q2W). **Intervention Names:** - Drug: IV Tulisokibart - Drug: SC Tulisokibart **Label:** Study 1: High Dose Induction, High Dose Maintenance **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants receive high dose induction of IV tulisokibart a total of 4 times on Day 1 and Weeks 2, 6, and 10. This is followed by a low dose maintenance of SC tulisokibart every 4 weeks (Q4W). **Intervention Names:** - Drug: IV Tulisokibart - Drug: SC Tulisokibart - Other: SC Placebo **Label:** Study 1: High Dose Induction, Low Dose Maintenance **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Participants receive low dose induction of IV tulisokibart a total of 4 times on Day 1 and Weeks 2, 6, and 10. This is followed by a low dose maintenance of SC tulisokibart Q4W. **Intervention Names:** - Drug: IV Tulisokibart - Drug: SC Tulisokibart - Other: SC Placebo **Label:** Study 1: Low Dose Induction, Low Dose Maintenance **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Participants receive IV placebo a total of 4 times on Day 1 and Weeks 2, 6, and 10. This is followed by SC placebo Q2W until week 52. In an extension, participants receive the low dose SC tulisokibart regimen. **Intervention Names:** - Other: IV Placebo - Other: SC Placebo **Label:** Study 1: Placebo **Type:** PLACEBO_COMPARATOR #### Arm Group 5 **Description:** Participants receive high dose induction of IV tulisokibart a total of 4 times on Day 1 and Weeks 2, 6, and 10. **Intervention Names:** - Drug: IV Tulisokibart - Drug: SC Tulisokibart **Label:** Study 2: High Dose Induction **Type:** EXPERIMENTAL #### Arm Group 6 **Description:** Participants receive low dose induction of IV tulisokibart a total of 4 times on Day 1 and Weeks 2, 6, and 10. **Intervention Names:** - Drug: IV Tulisokibart - Drug: SC Tulisokibart **Label:** Study 2: Low Dose Induction **Type:** EXPERIMENTAL #### Arm Group 7 **Description:** Participants receive IV placebo a total of 4 times on Day 1 and Weeks 2, 6, and 10. In an extension, participants receive the low dose SC tulisokibart regimen. **Intervention Names:** - Other: IV Placebo **Label:** Study 2: Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Study 1: High Dose Induction, High Dose Maintenance - Study 1: High Dose Induction, Low Dose Maintenance - Study 1: Low Dose Induction, Low Dose Maintenance - Study 2: High Dose Induction - Study 2: Low Dose Induction **Description:** Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously **Name:** IV Tulisokibart **Other Names:** - PRA023 - MK-7240 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Study 1: High Dose Induction, High Dose Maintenance - Study 1: High Dose Induction, Low Dose Maintenance - Study 1: Low Dose Induction, Low Dose Maintenance - Study 2: High Dose Induction - Study 2: Low Dose Induction **Description:** Humanized monoclonal antibody that binds human TL1A, administered subcutaneously **Name:** SC Tulisokibart **Other Names:** - PRA023 - MK-7240 **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Study 1: Placebo - Study 2: Placebo **Description:** Placebo matching IV tulisokibart **Name:** IV Placebo **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - Study 1: High Dose Induction, Low Dose Maintenance - Study 1: Low Dose Induction, Low Dose Maintenance - Study 1: Placebo **Description:** Placebo matching SC tulisokibart **Name:** SC Placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 1 will be presented. **Measure:** Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score at Week 52 **Time Frame:** Week 52 **Description:** The percentage of participants achieving clinical remission per stool frequency/abdominal pain score (SF/APS), as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 1 will be presented. **Measure:** Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52 **Time Frame:** Week 52 **Description:** The percentage of participants achieving endoscopic response, as defined by a 50% decrease in Simplified endoscopic score for Crohn's disease (SES-CD) from baseline for study 1 will be presented. **Measure:** Study 1: Percentage of Participants Achieving Endoscopic Response at Week 52 **Time Frame:** Week 52 **Description:** The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 1 will be presented. **Measure:** Study 1: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12 **Time Frame:** Week 12 **Description:** The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 1 will be presented. **Measure:** Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12 **Time Frame:** Week 12 **Description:** The percentage of participants achieving endoscopic response, as defined by a 50% decrease in SES-CD from baseline for study 1 will be presented. **Measure:** Study 1: Percentage of Participants Achieving Endoscopic Response at Week 12 **Time Frame:** Week 12 **Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE for study 1 will be presented. **Measure:** Study 1: Percentage of Participants Who Experienced an Adverse Event (AE) **Time Frame:** Up to approximately 222 weeks **Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study intervention due to an AE for study 1 will be presented. **Measure:** Study 1: Percentage of Participants who Discontinue Study Intervention due to an AE **Time Frame:** Up to approximately 208 weeks **Description:** The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 2 will be presented. **Measure:** Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12 **Time Frame:** Week 12 **Description:** The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 2 will be presented. **Measure:** Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12 **Time Frame:** Week 12 **Description:** The percentage of participants achieving endoscopic response, as defined by a 50% decrease in SES-CD from baseline for study 2 will be presented. **Measure:** Study 2: Percentage of Participants Achieving Endoscopic Response at Week 12 **Time Frame:** Week 12 **Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE for study 2 will be presented. **Measure:** Study 2: Percentage of Participants Who Experienced an AE **Time Frame:** Up to approximately 182 weeks **Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study intervention due to an AE for study 2 will be presented. **Measure:** Study 2: Percentage of Participants who Discontinue Study Intervention due to an AE **Time Frame:** Up to approximately 168 weeks #### Secondary Outcomes **Description:** The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 1 will be presented. **Measure:** Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12 **Time Frame:** Week 12 **Description:** The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 1 will be presented. **Measure:** Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12 **Time Frame:** Week 12 **Description:** The percentage of participants achieving a reduction in CDAI ≥100 points from baseline for study 1 will be presented. **Measure:** Study 1: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 12 **Time Frame:** Week 12 **Description:** The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0 to 52-point scale, with lower scores indicating greater fatigue. The mean change from baseline in FACIT-Fatigue score for study 1 will be presented. **Measure:** Study 1: Mean Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12 **Time Frame:** Baseline and Week 12 **Description:** The percentage of participants achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for study 1 will be presented. SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing), each on a scale from 0 to 3, in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, descending colon/sigmoid, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease. **Measure:** Study 1: Percentage of Participants Achieving Endoscopic Remission at Week 12 **Time Frame:** Week 12 **Description:** Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The percentage of Dx+ participants achieving clinical remission, as defined by CDAI score \<150 for study 1 and study 2 will be presented. **Measure:** Study 1 and 2: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Clinical Remission per CDAI at Week 12 **Time Frame:** Week 12 **Description:** Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The percentage of Dx+ participants achieving endoscopic response, as defined by a 50% decrease in simplified endoscopic score for Crohn's disease (CD) from baseline for study 1 and study 2 will be presented. **Measure:** Study 1 and 2: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Endoscopic Response at Week 12 **Time Frame:** Week 12 **Description:** The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 1 will be presented. **Measure:** Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52 **Time Frame:** Week 52 **Description:** The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 1 will be presented. **Measure:** Study 1: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 52 **Time Frame:** Week 52 **Description:** The percentage of participants achieving a reduction in CDAI ≥ 100 points from baseline for study 1 will be presented. **Measure:** Study 1: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 52 **Time Frame:** Week 52 **Description:** The percentage of participants achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for study 1 will be presented. SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing), each on a scale from 0 to 3, in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, descending colon/sigmoid, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease. **Measure:** Study 1: Percentage of Participants Achieving Endoscopic Remission at Week 52 **Time Frame:** Week 52 **Description:** The percentage of participants achieving sustained clinical remission, as defined by CDAI score \<150 for study 1 will be presented. **Measure:** Study 1: Percentage of Participants Achieving Sustained Clinical Remission per CDAI at Both Week 12 and Week 52 **Time Frame:** Week 12 and Week 52 **Description:** The percentage of participants who are in clinical remission as defined by CDAI score \<150 and without corticosteroid use for CD at least 90 days prior to that assessment for study 1 will be presented. **Measure:** Study 1: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per CDAI Score at Week 52 **Time Frame:** Week 52 **Description:** The percentage of participants who are in clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline and without corticosteroid use for CD at least 90 days prior to that assessment for study 1 will be presented. **Measure:** Study 1: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52 **Time Frame:** Week 52 **Description:** The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline and achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for study 1 will be presented. **Measure:** Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency, Abdominal Pain Score, and Endoscopic Remission at Week 52 **Time Frame:** Week 52 **Description:** The percentage of participants achieving clinical remission as defined by CDAI score \<150 and achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for study 1 will be presented. **Measure:** Study 1: Percentage of Participants Achieving Clinical Remission per CDAI and Endoscopic Remission at Week 52 **Time Frame:** Week 52 **Description:** The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0 to 52-point scale, with lower scores indicating greater. The mean change from baseline in FACIT-Fatigue score for study 1 will be presented. **Measure:** Study 1: Mean Change from Baseline in FACIT-Fatigue Score at Week 52 **Time Frame:** Baseline and Week 52 **Description:** The IBDQ measures health related quality of life in participants with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges between 32 to 224 with higher scores indicating a better quality of life. The mean change from baseline in IBDQ score for study 1 will be presented. **Measure:** Study 1: Mean Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 52 **Time Frame:** Baseline and Week 52 **Description:** The percentage of participants achieving ulcer-free endoscopy (mucosal healing), as defined by SES-CD ulcerated surface subscore of 0 in participants with SES-CD ulcerated surface subscore ≥1 at baseline for study 1 will be presented. **Measure:** Study 1: Percentage of Participants with Ulcer-Free Endoscopy at Week 52 **Time Frame:** Week 52 **Description:** The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 2 will be presented. **Measure:** Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12 **Time Frame:** Week 12 **Description:** The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 2 will be presented. **Measure:** Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12 **Time Frame:** Week 12 **Description:** The percentage of participants achieving a reduction in CDAI ≥ 100 points from baseline for study 2 will be presented. **Measure:** Study 2: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 12 **Time Frame:** Week 12 **Description:** The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0 to 52-point scale, with lower scores indicating greater. The mean change from baseline in FACIT-Fatigue score for study 2 will be presented. **Measure:** Study 2: Mean Change from Baseline in FACIT-Fatigue Score at Week 12 **Time Frame:** Baseline and Week 12 **Description:** The percentage of participants achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for study 2 will be presented. SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing), each on a scale from 0 to 3, in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, descending colon/sigmoid, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease. **Measure:** Study 2: Percentage of Participants Achieving Endoscopic Remission at Week 12 **Time Frame:** Week 12 **Description:** The IBDQ measures health related quality of life in participants with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges between 32 to 224 with higher scores indicating a better quality of life. The mean change from baseline in IBDQ score for study 2 will be presented. **Measure:** Study 2: Mean Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12 **Time Frame:** Baseline and Week 12 **Description:** The percentage of participants achieving a reduction in CDAI ≥ 100 points from baseline for study 2 will be presented. **Measure:** Study 2: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 6 **Time Frame:** Week 6 **Description:** The percentage of participants achieving ulcer-free endoscopy (mucosal healing), as defined by SES-CD ulcerated surface subscore of 0 in participants with SES-CD ulcerated surface subscore ≥1 at baseline for study 1 will be presented. **Measure:** Study 2: The percentage of Participants with Ulcer-Free Endoscopy at Week 12 **Time Frame:** Week 12 ### Eligibility Module **Eligibility Criteria:** The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Has had a diagnosis of CD at least 3 months before study. * Has moderately to severely active CD. * Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies. Exclusion Criteria: * Has diagnosis of ulcerative colitis (UC) or indeterminate colitis. * Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement. * Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study. * Has current stoma or need for colostomy or ileostomy. * Is missing \>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum. * Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides Crohn's disease. * Has surgical bowel resection within 3 months of study. * Has prior or current gastrointestinal dysplasia. * Has chronic infection requiring ongoing antimicrobial treatment. * Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years. * Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV). * Has active tuberculosis. * Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection. * Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-anti-TL1A antibody. **Maximum Age:** 75 Years **Minimum Age:** 16 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Merck Sharp & Dohme LLC **Name:** Medical Director **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf **IPD Sharing:** YES **URL:** http://engagezone.msd.com/ds_documentation.php ### References Module #### See Also Links **Label:** Merck Clinical Trials Information **URL:** https://www.merckclinicaltrials.com ## Derived Section ### Condition Browse Module - Ancestors - ID: D000015212 - Term: Inflammatory Bowel Diseases - ID: D000005759 - Term: Gastroenteritis - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000007410 - Term: Intestinal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6638 - Name: Crohn Disease - Relevance: HIGH - As Found: Crohn's Disease - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M17917 - Name: Inflammatory Bowel Diseases - Relevance: LOW - As Found: Unknown - ID: M8875 - Name: Gastroenteritis - 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 ### Condition Browse Module - Meshes - ID: D000003424 - Term: Crohn Disease ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4230 - Name: Antibodies, Monoclonal - Relevance: LOW - As Found: Unknown - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430788 **Brief Title:** A Study of Emapalumab for Pediatric Aplastic Anemia **Official Title:** Phase 2a/2b Study Emapalumab: A Window of Opportunity in Pediatric Aplastic Anemia #### Organization Study ID Info **ID:** 23-278 #### Organization **Class:** OTHER **Full Name:** Memorial Sloan Kettering Cancer Center ### Status Module #### Completion Date **Date:** 2029-05-21 **Type:** ESTIMATED #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2029-05-21 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-21 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Memorial Sloan Kettering Cancer Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** The purpose of this study is to find out whether upfront emapalumab treatment can help in sAA (Aplastic Anemia) treatment planning and increase the effectiveness of standard treatment options. ### Conditions Module **Conditions:** - Aplastic Anemia - Cytopenia - Hypocellular Marrow **Keywords:** - pediatric aplastic anemia - aplastic anemia - cytopenia - hypocellular marrow - Emapalumab - Memorial Sloan Kettering Cancer Center - 23-278 ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 55 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will first receive Emapalumab for 6 weeks. After treatment with emapalumab, participants will receive standard IST with drugs called equine anti-thymocyte globulin (hATG) and cyclosporin (CsA) in addition to a lower dose of emapalumab **Intervention Names:** - Biological: Emapalumab **Label:** Emapalumab, then Standard IST **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will first receive Emapalumab for 6 weeks. After treatment with emapalumab, participants will have a standard hematopoietic stem cell transplant (HCT). **Intervention Names:** - Biological: Emapalumab **Label:** Emapalumab, then HCT **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Emapalumab, then HCT - Emapalumab, then Standard IST **Description:** Emapalumab is an interferon gamma (IFNγ) blocking antibody **Name:** Emapalumab **Other Names:** - Gamifant **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** The primary objective of the study is to assess the efficacy of early upfront emapalumab on hematologic recovery within 6 weeks of starting therapy after a new diagnosis of Aplastic Anemia. Response will be determined by blood count. **Measure:** Best Response **Time Frame:** 6 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients undergoing workup for suspected newly diagnosed sAA: * Patients with severe cytopenias and a hypocellular marrow concerning for sAA * Patients that meet the definition for suspected sAA (Camitta Criteria) as follows: Marrow Cellularity: \<25%, or 25-50% with \<30% residual hematopoietic cells Peripheral cytopenias (at least 2 of 3) Absolute neutrophil count (ANC): \<500 x 10\^9/L Platelets: \<20 x 10\^9/L Absolute Reticulocyte Count: \<60 x 10\^9/L * Patients that do not have evidence of leukemia or MDS * Patients \< 25 years of age at time of diagnosis * Able to tolerate emapalumab and IST (with standard institutional organ function criteria) Exclusion Criteria: * Uncontrolled infection at presentation. * Patients who have undergone previous treatment for sAA. * Patients with known inherited bone marrow failure * Patient who has completed a full workup for sAA including having results back from telomere testing, DEB and genetics (when applicable), as well as having an appropriate willing and available donor and would otherwise be admitted for HSCT within 2 weeks of enrolling on the trial * Patients with leukemia or MDS * Patient or parent or guardian unable to give informed consent or unable to comply with the treatment protocol including research tests. **Healthy Volunteers:** True **Maximum Age:** 25 Years **Minimum Age:** 0 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Joseph Oved, MD **Phone:** 1-833-MSK-KIDS **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Jaap Jan Boelens, MD, PhD **Phone:** 1-833-MSK-KIDS **Role:** CONTACT #### Locations **Location 1:** **City:** New York **Contacts:** ***Contact 1:*** - **Name:** Joseph Oved, MD - **Phone:** 1-833-MSK-KIDS - **Role:** CONTACT **Country:** United States **Facility:** Memorial Sloan Kettering Cancer Center (All Protocol Activities) **State:** New York **Status:** RECRUITING **Zip:** 10065 **Location 2:** **City:** Cincinnati **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Anthony Sabulski, MD - **Phone:** 513-636-3200 - **Role:** CONTACT **Country:** United States **Facility:** Cincinnati Children's Hospital Medical Center (Data collection only) **State:** Ohio **Status:** NOT_YET_RECRUITING **Zip:** 45229 **Location 3:** **City:** Philadelphia **Contacts:** ***Contact 1:*** - **Name:** Tim Olson, MD, PhD - **Phone:** 800-879-2467 - **Role:** CONTACT **Country:** United States **Facility:** Children's Hospital of Philadelphia (Data Collection AND Specimen Analysis) **State:** Pennsylvania **Status:** NOT_YET_RECRUITING **Zip:** 19104 **Location 4:** **City:** Richmond **Contacts:** ***Contact 1:*** - **Name:** Joe Laver, MD, MHA - **Phone:** 804-828-9213 - **Role:** CONTACT **Country:** United States **Facility:** Virginia Commonwealth Univeristy (Data Collection Only ) **State:** Virginia **Status:** NOT_YET_RECRUITING **Zip:** 23219 **Location 5:** **City:** Milwaukee **Contacts:** ***Contact 1:*** - **Name:** Larisa Broglie, MD - **Phone:** 414-266-2420 - **Role:** CONTACT **Country:** United States **Facility:** Medical College of Wisconsin (Data Collection AND Data Analysis) **State:** Wisconsin **Status:** NOT_YET_RECRUITING **Zip:** 53226 #### Overall Officials **Official 1:** **Affiliation:** Memorial Sloan Kettering Cancer Center **Name:** Joseph Oved, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: [email protected]. **IPD Sharing:** YES ### References Module #### See Also Links **Label:** Memorial Sloan Kettering Cancer Center **URL:** http://www.mskcc.org ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006402 - Term: Hematologic Diseases - ID: D000080983 - Term: Bone Marrow Failure Disorders - ID: D000001855 - Term: Bone Marrow Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M3170 - Name: Cytopenia - Relevance: HIGH - As Found: Cytopenia - ID: M4070 - Name: Anemia - Relevance: HIGH - As Found: Anemia - ID: M4071 - Name: Anemia, Aplastic - Relevance: HIGH - As Found: Aplastic Anemia - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2241 - Name: Bone Marrow Failure Disorders - Relevance: LOW - As Found: Unknown - ID: M13118 - Name: Pancytopenia - Relevance: LOW - As Found: Unknown - ID: M5134 - Name: Bone Marrow Diseases - Relevance: LOW - As Found: Unknown - ID: T460 - Name: Aplastic Anemia - Relevance: HIGH - As Found: Aplastic Anemia ### Condition Browse Module - Meshes - ID: D000000740 - Term: Anemia - ID: D000000741 - Term: Anemia, Aplastic - ID: D000095542 - Term: Cytopenia ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: ANeo - Name: Antineoplastic Agents ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M18961 - Name: Cyclosporine - Relevance: LOW - As Found: Unknown - ID: M6730 - Name: Cyclosporins - Relevance: LOW - As Found: Unknown - ID: M10407 - Name: Interferons - Relevance: LOW - As Found: Unknown - ID: M4279 - Name: Antilymphocyte Serum - Relevance: LOW - As Found: Unknown - ID: M21134 - Name: Antibodies, Blocking - Relevance: LOW - As Found: Unknown - ID: M10406 - Name: Interferon-gamma - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430775 **Brief Title:** Exploring Prolonged AMR in ACL Reconstructed Patients **Official Title:** Exploring Prolonged Arthrogenic Muscle Responses and Associated Factors After Anterior Cruciate Ligament Reconstruction #### Organization Study ID Info **ID:** G086223N #### Organization **Class:** OTHER **Full Name:** University Ghent #### Secondary ID Infos **Domain:** Ethical committee Ghent University **ID:** ONZ-2023-0365 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Research Foundation Flanders #### Lead Sponsor **Class:** OTHER **Name:** University 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:** The goal of this observational study is to explore the significance of subject-reported outcomes and clinical parameters in relation to the occurence of prolonged presence of arthrogenic muscle responses (AMR) in anterior cruciate ligament (ACL) reconstructed patients. The main questions it aims to answer are: 1. Is there a link between the long-term occurence of AMR in ACL reconstructed patients and the level of kinesiophobia experienced before or after their ACL surgery? We hypothesize that ACL patients with higher levels of kinesiophobia are more likely to exhibit prolonged AMR as an unconscious reaction to protect their affected knee joint. 2. Is the long-term presence of AMR in ACL reconstructed patients linked to their subjective knee function and stability (at certain time points throughout their recovery)? Our hypothesis is that poorer subjective knee function and stability might be associated with the presence of prolonged arthrogenic muscle responses in ACL reconstructed patients. 3. Is the prolonged presence of AMR in ACL reconstructed patients linked to their pain levels (at certain time points throughout their recovery)? Our hypothesis is that ACL patients with higher pre- and/or postsurgical pain levels may exhibit a higher degree of long-lasting AMR. 4. Is the long-term presence of AMR in ACL reconstructed patients linked to clinical parameters such as swelling, isometrich quadriceps and hamstrings strength and knee range of motion (at certain time points throughout their recovery)? Our hypothesis is that ACL patients with poorer outcomes in terms of these clinical parameters may be more likely to exhibit prolonged AMR. Participants will: * Fill in the following questionnaires 1 week before surgery and at 1 and 3 months after surgery: * Demopgraphical information * Knee Injury and Osteoarthritis Outcome Score (KOOS) * Lysholm Score (only question 1) * Tegner Activity Scale (current activity level, pre-injury activity level and desired activity level after recovery) * Numeric Rating Score (NRS) for pain levels during the day \& during the night * ACL-Return to Sport after Injury Scale (ACL-RSI) * Complete a testing protocol 5 months after their surgery, which includes bilateral electromyographical measurements of the hamstrings and quadriceps during jumping tasks and a quadriceps inhibition measurement using the interpolated twitch method to evaluate the presence of prolonged AMR. ### Conditions Module **Conditions:** - Anterior Cruciate Ligament Injuries - Anterior Cruciate Ligament Rupture - Anterior Cruciate Ligament Tear - ACL - ACL Injury - ACL Tear - Anterior Cruciate Ligament Reconstruction - Arthrogenic Muscle Inhibition - Arthrogenic Muscle Responses ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 190 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 5 Months ### Arms Interventions Module #### Arm Group 1 **Description:** The participants to be studied will have an anterior cruciate ligament injury for which surgical treatment is scheduled. **Label:** ACLR-patients ### Outcomes Module #### Primary Outcomes **Description:** A torque-based isometric biodex measurement using the interpolated twitch technique. **Measure:** Voluntary quadriceps activation **Time Frame:** 5 months post ACL reconstruction **Description:** Electromyographical measurement of quadriceps and hamstrings activation during jumping tasks: bilateral countermovement jump, unilateral countermovement jump and unilateral vertical drop jump with a 90° medial turn. **Measure:** Quadriceps and hamstrings activity / cocontraction during jumping tasks **Time Frame:** 5 months post ACL reconstruction #### Secondary Outcomes **Description:** Concentric and isokinetic Biodex measurements of the quadriceps and hamstrings strength. **Measure:** Quadriceps and hamstrings strength **Time Frame:** 5 months post ACL reconstruction ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18-40 years old. * Having suffered an ACL rupture. * Undergoing a surgical ACL reconstruction in the AZ Delta hospital in Roeselare (Campus Brugsesteenweg). Exclusion Criteria: * Revision ACL reconstruction. * Other severe injuries to the lower limbs within the past year. * Muscular or neurological disorders affecting lower limb functioning. * Fibromyalgia or chronic fatigue syndrome. **Maximum Age:** 40 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** Patients aged between 18 and 40 who have suffered an ACL rupture and for whom ACL reconstructive surgery is planned at AZ Delta Hospital in Roeselare. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Erik Witvrouw, prof. dr. **Phone:** +32 9 332 2609 **Role:** CONTACT #### Locations **Location 1:** **City:** Roeselare **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Thomas Tampere, Dr. - **Phone:** 051 23 63 70 - **Role:** CONTACT **Country:** Belgium **Facility:** AZ Delta Hospital (Campus Brugsesteenweg) **State:** West-Vlaanderen **Status:** RECRUITING **Zip:** 8800 ### IPD Sharing Statement Module **Description:** All collected IPD that underlie results in a publication will be shared. **Info Types:** - STUDY_PROTOCOL - SAP **IPD Sharing:** YES **Time Frame:** The data will become available after publication. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007718 - Term: Knee Injuries - ID: D000007869 - Term: Leg Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M15241 - Name: Rupture - Relevance: HIGH - As Found: Rupture - ID: M22785 - Name: Lacerations - Relevance: LOW - As Found: Unknown - ID: M601 - Name: Anterior Cruciate Ligament Injuries - Relevance: HIGH - As Found: Anterior Cruciate Ligament Injuries - ID: M17685 - Name: Wounds and Injuries - Relevance: HIGH - As Found: Injury - ID: M10738 - Name: Knee Injuries - Relevance: LOW - As Found: Unknown - ID: M10881 - Name: Leg Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014947 - Term: Wounds and Injuries - ID: D000012421 - Term: Rupture - ID: D000070598 - Term: Anterior Cruciate Ligament Injuries ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430762 **Brief Title:** Therapeutic Exposures and Risk Factors in MRONJ **Official Title:** Identification of Therapeutic Exposures and Risk Factors Associated With Medication-Related Osteonecrosis of the Jaw #### Organization Study ID Info **ID:** CIBON-MAR-A.1 #### Organization **Class:** OTHER **Full Name:** Marmara University ### Status Module #### Completion Date **Date:** 2027-04-26 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-04-25 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-25 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Marmara University #### Responsible Party **Investigator Affiliation:** Marmara University **Investigator Full Name:** Ferit Bayram **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:** This study focuses on patients who have developed a condition called medication-related osteonecrosis of the jaw (MRONJ), which can occur after using certain medications. The purpose is to closely monitor these patients over time to better understand how they are diagnosed, treated, and followed up. By doing this, researchers hope to uncover how different factors such as a patient's background, lifestyle, and other health conditions might influence their recovery and overall quality of life. ### Conditions Module **Conditions:** - Medication-Related Osteonecrosis of Jaw ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 250 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** This outcome measures the overall health status and activity levels of patients with MRONJ using the Karnofsky Performance Scale (KPS). KPS rates patients on a scale from 0 to 100, where higher scores indicate greater independence and lower morbidity risk, while lower scores reflect dependency and the need for substantial medical intervention. The scale's aim is to quantify the extent to which patients can perform everyday life activities without assistance. At baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3), 18 and 24 months (T4, if required), the questionnaire will be taken. **Measure:** Change in Karnofsky Performance Status **Time Frame:** 24 months **Description:** A scale of 1 to 5 will be used to rate each of the 14 questions about how dental health affects quality of life (minimum score of 0, maximum score of 70). Higher ratings reflect a greater influence of the patient's dental health on their quality of life (higher scores, worse outcomes). At baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3), 18 and 24 months (T4, if required), the questionnaire will be taken. **Measure:** Change in Oral Health-related Quality of Life **Time Frame:** 24 months **Description:** Staging of the lesion in the mouth will be according to the definition of the American Association of Oral and Maxillofacial Surgeons (Ruggiero et al. 2022). Clinical examination will be performed at baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3), 18 and 24 months (T4, if necessary). **Measure:** Change in staging of MRONJ **Time Frame:** 24 months **Description:** Various biochemical markers indicative of bone metabolism and inflammatory response in patients with medication-related osteonecrosis of the jaw (MRONJ) will be evaluated. The markers include serum calcium, ionized calcium, parathyroid hormone (PTH), alkaline phosphatase, osteocalcin, C-telopeptide (CTX), Vitamin D3, C-reactive protein (CRP), and leukocyte count. Blood samples collected at baseline will be analyzed. **Measure:** Biochemical Markers Related to Bone Metabolism and Inflammatory Response **Time Frame:** Baseline **Description:** This outcome involves utilizing the Composite Radiographic Index to track and characterize the progression of lesions in patients with medication-related osteonecrosis of the jaw. This index evaluates: * Location of the lesion: Maxilla anterior, Maxilla posterior, Mandible anterior, Mandibular posterior. * Lyric changes: Scored as 0 (None), 1 (Localized), 2 (Widespread). * Sclerosis: Scored as 0 (None), 1 (Localized), 2 (Widespread). * Periosteal bone formation: Scored as 0 (None), 1 (Localized), 2 (Widespread). * Sequestration: Scored as 0 (None), 1 (Localized), 2 (Widespread). Radiographs will be taken at the initial visit to establish a baseline for each patient. Subsequent radiographs will be taken only if clinically indicated to monitor the presence and progression of osteonecrotic lesions. **Measure:** Change in the Assessment of Radiographic Changes Using the Composite Radiographic Index **Time Frame:** 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Individuals aged 18 and over * Male or female individuals * Individuals who apply to the Marmara University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery due to medication-related osteonecrosis of jaw during the study period * Individuals or their legal representatives who have given written consent to participate in the study Exclusion Criteria: * Non-drug-related osteonecrosis/osteomyelitis * Osteoradionecrosis * Metastasis to the oral region * Individuals who have not given written consent to participate in the study * Individuals under the age of 18 **Healthy Volunteers:** True **Maximum Age:** 110 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study population for this research comprises individuals aged 18 and over, both male and female, who present with medication-related osteonecrosis of the jaw (MRONJ) at the Oral and Maxillofacial Surgery Clinic of Marmara University Faculty of Dentistry. The study excludes individuals with non-drug-related osteonecrosis or osteomyelitis, osteoradionecrosis, those with metastasis to the oral region, individuals who have not provided consent, and those under the age of 18. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ferit Bayram, PhD **Phone:** 00902167775000 **Role:** CONTACT #### Locations **Location 1:** **City:** Istanbul **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ferit Bayram, Ph. D. - **Phone:** 2167775074 - **Role:** CONTACT ***Contact 2:*** - **Name:** Ahmet Akıcı, Prof. Dr. - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Tunç Akkoç, Prof. Dr. - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Korkut Ulucan, Prof. Dr. - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 5:*** - **Name:** Volkan Aydın, Assoc. Prof. - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 6:*** - **Name:** Gökhan Göçmen, Assoc. Prof. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Turkey **Facility:** Marmara University School of Dentistry **Status:** RECRUITING **Zip:** 34854 #### Overall Officials **Official 1:** **Affiliation:** Marmara University Faculty of Dentistry **Name:** Ferit Bayram, PhD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Ruggiero SL, Dodson TB, Aghaloo T, Carlson ER, Ward BB, Kademani D. American Association of Oral and Maxillofacial Surgeons' Position Paper on Medication-Related Osteonecrosis of the Jaws-2022 Update. J Oral Maxillofac Surg. 2022 May;80(5):920-943. doi: 10.1016/j.joms.2022.02.008. Epub 2022 Feb 21. **PMID:** 35300956 **Citation:** Friendlander AH, Ettinger RL. Karnofsky performance status scale. Spec Care Dentist. 2009 Jul-Aug;29(4):147-8. doi: 10.1111/j.1754-4505.2009.00088.x. No abstract available. **PMID:** 19573040 **Citation:** Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x. **PMID:** 9332805 #### See Also Links **Label:** AAOMS MRONJ staging **URL:** https://www.aaoms.org/docs/govt_affairs/advocacy_white_papers/mronj_position_paper.pdf ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000009336 - Term: Necrosis - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12943 - Name: Osteonecrosis - Relevance: HIGH - As Found: Osteonecrosis - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M12284 - Name: Necrosis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010020 - Term: Osteonecrosis ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430749 **Acronym:** MicroPro2 **Brief Title:** Targeted Microwave Tissue Coagulation for Prostate Cancer **Official Title:** Clinical Trial of Evaluating Efficacy and Safety for Percutaneously Prostate Cancer Lesion Targeted Microwave Tissue Coagulation as Prostate Functional Preservation #### Organization Study ID Info **ID:** CTREC-S220202 #### Organization **Class:** OTHER **Full Name:** Kyoto Prefectural University of Medicine #### Secondary ID Infos **Domain:** Japan Registry of Clincal Trials **ID:** jRCTs052240015 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2027-10-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-10-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Osamu Ukimura #### Responsible Party **Investigator Affiliation:** Kyoto Prefectural University of Medicine **Investigator Full Name:** Osamu Ukimura **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:** This clinical trial is to provide a minimally invasive treatment option in which the targeted prostate cancer tissue is killed by microwave only in the specific area of cancer "that should be treated for saving of life"; while, leaving a portion of the normal prostate tissue that is not cancerous. It is a treatment, named by "focal therapy" for "clinically localized prostate cancer". As this new treatment is aiming to treat only specific prostatic area of cancer, it is different from the invasive conventional treatment to remove the entire prostate gland. The goal is to achieve both to control of known cancer by treating only the cancerous area and to maintain of QOL (Quality-of-life) by leaving of the other normal prostate tissue and its surrounding organs intact resulting in prevention of urinary-leakage and sexual-dysfunction as the complications. **Detailed Description:** This trial will to provide an ultrasound-guided targeted microwave tissue coagulation of known cancer lesions in patients diagnosed with clinically localized prostate cancer, and this trial will assess efficacy and safety endpoints for up to post-operative 6 months. This trial will assess patient quality of life (QOL) as well. ### Conditions Module **Conditions:** - Prostate Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Single Group Assignment ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 65 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The Minimally invasive microwave coagulation surgery will be performed under general anesthesia for aiming to be provided total 65 patients. **Intervention Names:** - Device: Microtaze **Label:** Microwave Tissue Coagulation Arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Microwave Tissue Coagulation Arm **Description:** Targeted Microwave Tissue Coagultion **Name:** Microtaze **Other Names:** - AFM-712 **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Achievement of 1) serum marker, 2) imaging, and 3) histopathological examination, below 1. A 50% or greater reduction from the preoperative serum PSA level at postoperative 3 or 6 months 2. A reduction of PI-RADS category of the targeted prostate cancer lesion down to 3 or lower (Including 'difficult to judge' and 'change after treatment') at MRI images at postoperative 6 months 3. No cancer tissue in histopathological examination from the targeted prostate cancer lesion via a needle biopsy of the prostate performed at postoperative 6 months **Measure:** Disappearance of cancer at 6 month after microwave coagulation evaluated by combination of the responses in PSA, MRI, and Prostate biopsy **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients who have a single lesion of PI-RADS category 3 or 4 lesion on MRI image at enrollment and which is proved as a Gleason score 7 or 8 on histopathology of the prostate needle biopsy at enrollment; or, patients who have a single lesion of PI-RADS category 4 or 5 lesion on MRI image at enrollment and which is proved as a Gleason score 6 or 7 on histopathology of the prostate needle biopsy at enrollment 2. Patients with prostate cancer that is clinical stage T2c or lower (T1a-T2cN0M0) according to the TNM Classification as determined during enrollment 3. Patients between the ages of 20 and 85 when providing consent to participate in this trial 4. Patients from whom consent is obtained prior to enrollment in this trial Exclusion Criteria: 1. Patients to have a lesion identified as PI-RADS category 4 or 5 on MRI images at enrollment and which is a diameter of less than 10 mm and Gleason score of 6 on the histopathology of the prostate needle biopsy at enrollment (the lesion is referred to as 'non-target lesions') (the diameter of the lesion is defined as the longer one of the lesion diameter identified on MRI images at enrollment or the tumor length as measured on histopathology of prostate needle biopsy) 2. Patients to have 4 or more non-target lesions (non-target lesions are defined as the lesions defined in exclusion criterion 1, or lesions with PI-RADS category 3 on MRI image at enrollment and Gleason score 6 on biopsy at enrollment) 3. Patients to have a lesion with PI-RADS category 5 on MRI image at enrollment and Gleason score 8 on histopathology of prostate needle biopsy at enrollment (the lesion is referred 'excluded lesions') 4. Patients with a serum prostate-specific antigen (PSA) level over 20 ng/ml during enrollment 5. Patients in whom the distance from the target prostate cancer lesion to the rectum is 10 mm or less on MRI images (coronal or sagittal) obtained during enrollment 6. Patients who have received an antiandrogen for benign prostatic hyperplasia prior to enrollment 7. Patients who have received an antiandrogen for benign prostatic hyperplasia prior to enrollment 8. Patients who have undergone surgery, drug therapy, or radiation therapy for prostate cancer prior to enrollment 9. Patients with active multiple cancers 10. Patient who wear a pacemaker 11. Patients for whom MRI scans are contraindicated 12. Patients in whom transrectal ultrasound cannot be performed for some reason, such as a constricted rectum 13. Patients with a prothrombin time\<50% or platelet count\<60,000/mm3 during enrollment 14. Patients deemed to be ineligible by an investigator **Maximum Age:** 85 Years **Minimum Age:** 20 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Osamu Ukimura, Professor **Phone:** +81 75 251 5595 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Toshiko Ito-Ihara, M.D. **Phone:** +81 75 251 5308 **Role:** CONTACT #### Locations **Location 1:** **City:** Kyoto **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Osamu Ukimura, M.D., Ph.D. - **Phone:** +81 75 251 5595 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Toshiko Ito-Ihara, M.D., Ph.D. - **Phone:** +81 75 251 5308 - **Role:** CONTACT **Country:** Japan **Facility:** Kyoto Prefectural University of Medicine **Status:** RECRUITING **Zip:** 602-8566 #### Overall Officials **Official 1:** **Affiliation:** Kyoto Prefectural University of Medicine **Name:** Osamu Ukimura, Professor **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005834 - Term: Genital Neoplasms, Male - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000005832 - Term: Genital Diseases, Male - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000011469 - Term: Prostatic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14335 - Name: Prostatic Neoplasms - Relevance: HIGH - As Found: Prostate Cancer - ID: M8946 - Name: Genital Neoplasms, Male - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M8944 - Name: Genital Diseases, Male - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14333 - Name: Prostatic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011471 - Term: Prostatic Neoplasms ### 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:** NCT06430736 **Acronym:** PRONTO **Brief Title:** PRONTO Trial (PRophylactic Versus ON-demand Use of TOcilizumab) **Official Title:** Prospective Comparison Between Prophylactic and On-demand Use of Tocilizumab in CAR-T Recipients - a Randomized, Two Arm, Open-label, Single-center Trial #### Organization Study ID Info **ID:** PRONTO #### Organization **Class:** OTHER **Full Name:** Insel Gruppe AG, University Hospital Bern ### Status Module #### Completion Date **Date:** 2027-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Insel Gruppe AG, University Hospital Bern #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Despite the consequent use of Tocilizumab together with conventional antipyretics at early/first signs of emerging CRS, CRS (and eventually the subsequent development of ICANS) remain a major concern for patients. This study aims to identify safety and efficacy of prophylactic Tocilizumab treatment. In particular, to explore whether prophylactic Tocilizumab treatment can decrease the incidence and severity of CRS (and subsequent eventual neurotoxicity) following CAR-T-treatment. **Detailed Description:** Adoptive immunotherapy with CD19 (cluster of differentiation antigen 19) targeting chimeric antigen-receptor (CAR-)T cells is an effective therapeutic strategy against relapsed or refractory B-cell malignancies, including B-cell lymphomas, B-ALL (acute lymphoblastic leukemia) and myeloma. Currently, up to 50 commercial CAR-T-cell treatments are performed annually at the Inselspital in Bern, making it by far the largest center for CAR-T cell treatment in Switzerland. CAR-T treatment is associated with well-described acute adverse events, including cytokine release syndrome (CRS) and neurotoxicity, termed immune effector cell associated neurologic syndrome (ICANS). CRS (at all grades) occurs in between 42 to 93% of all patients with variations among available products, and ICANS can occur (at all grades) in 21% up to 64%. Acute complications of CAR-T cell therapy are the result of rapid CAR-T cell expansion and of a hyper-inflammatory state related to cell activation. Interleukin (IL-6) is a central mediator of cytokine-responses in CRS and ICANS together with other cytokines and chemokines involved. IL-6 interacts with its receptor (IL-6R) in either membrane-bound form, leading to "classic" IL-6 signaling after interacting with GP130, or soluble in plasma, where the IL-6 / IL-6R complex interacts with GP130 expressing cells in "trans" IL-6 signaling. Tocilizumab is a humanized monoclonal antibody that binds the IL-6R in both its soluble and membrane-bound forms. Tocilizumab treatment has become the standard of care for patients presenting with CRS (at all grades), together with antipyretic treatment (grades 1 or 2 at the regular ward) or with vasoactive and/or ventilation support at the intensive care unit (grades 3 and 4). The study aims to assess the incidence of CRS of all grades, as well as the incidence of ICANS of all grades, the duration of hospitalisation and the need of platelet and erythrocyte transfusion within the first three months after CAR-T treatment in patients receiving prophylactic Tocilizumab compared to patients receiving on-demand Tocilizumab. ### Conditions Module **Conditions:** - Myeloma - Lymphoma - Leukemia **Keywords:** - Tocilizumab - Myeloma - Leukemia - Lymphoma - CRS - ICANS ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized, two arm, open-label, single-center trial. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In the experimental arm, patients will receive a single standard dose of Tocilizumab (Actemra®) 8 mg/kg b.w. intravenously infused over 1 hour in 250 ml NaCl 0.9%, with completion of the infusion 1 hour prior to the infusion of the CAR-T cells. Prior to Tocilizumab administration, no specific premedication is given. The treatment of eventual subsequent CRS will be identical as in patients in the standard arm. **Intervention Names:** - Drug: Tocilizumab before CAR-T cell infusion **Label:** Tocilizumab prophylactic **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** In the standard arm, patients will receive conventional antipyretics and Tocilizumab at first clinical signs (being grade 1 or higher) of emerging CRS. Tocilizumab will be given at the standard-dose of 8 mg/kg b.w. intravenously over one hour in 250 ml NaCl 0.9%, and it will be repeated after 8 hours for a maximum of four administrations in patients with ongoing signs of CRS. Prior to Tocilizumab administration, no specific premedication is given. **Intervention Names:** - Drug: Tocilizumab at emerging CRS **Label:** Tocilizumab on demand **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Tocilizumab prophylactic **Description:** Tocilizumab will be given at the standard-dose of 8 mg/kg b.w. intravenously, with completion of the infusion 1 hour prior to infusion of CAR-T cells. Treatment of eventual subsequent CRS/ICANS will be identical as in patients in the standard arm. **Name:** Tocilizumab before CAR-T cell infusion **Other Names:** - Prophylactic **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Tocilizumab on demand **Description:** Tocilizumab will be given at the standard-dose of 8 mg/kg b.w. intravenously, and it will be repeated after 8 hours for a maximum of four administrations in patients with ongoing signs of CRS. **Name:** Tocilizumab at emerging CRS **Other Names:** - On demand **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Number of patients with CRS of any grade according to the ASTCT (American Society for Transplantation and Cellular Therapy ) Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells ; including use of antipyretics **Measure:** Incidence of CRS of all grades **Time Frame:** 30 days #### Secondary Outcomes **Description:** Number of patients with ICANS of any grade according to the ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells ; including use of antipyretics **Measure:** Incidence of ICANS of all grades **Time Frame:** 30 days **Description:** Number of days from admission to discharge from hospital **Measure:** Hospitalization duration **Time Frame:** 30 days **Description:** Number of transfusion (erythrocyte) given **Measure:** Erythrocyte transfusion needs **Time Frame:** 90 days **Description:** Number of transfusion (platelet) given **Measure:** Platelet transfusion needs **Time Frame:** 90 days **Description:** Number of admissions to the intensive care unit **Measure:** Incidence of admissions to the intensive care unit **Time Frame:** 30 days **Description:** Number of infections per patient **Measure:** Incidence of infections **Time Frame:** 90 days **Description:** Overall survival assessment are based on physician's reporting of the assessments of the various disease types involved at day 90 and day 180 **Measure:** Overall survival rates **Time Frame:** 180 days **Description:** Relapse assessment are based on physician's reporting of the assessments of the various disease types involved at day 90 and day 180 **Measure:** Progression-free survival rates **Time Frame:** 180 days **Description:** daily assessment of IL-6 during the hospitalisation and at day 90 and day 180 **Measure:** IL-6 to monitor CRS **Time Frame:** 180 days **Description:** Peripheral molecular DNA CAR-T level measurement performed at day 0, day 8 and once a month during months 2 to 6 **Measure:** Peripheral molecular CAR-T levels **Time Frame:** 180 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients planned to receive commercial CAR-T treatment for all registered indications comprising lymphomas, leukemias or myeloma at a single academic center (Bern Inselspital) * With written informed consent * Considered by the investigator to be clinically fit for this treatment * Patients aged ≥18 years Exclusion Criteria: * Previous Tocilizumab treatment within 3 months prior to CAR-T infusion * Patients with treatment with an investigational compound within 8 weeks prior to CAR-T infusion * Women who are pregnant or breast feeding, or women intending to become pregnant during the study period; or participants lacking safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases during study treatment and for a total of 12 months; Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential. * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * Previous enrolment into the current study * Enrolment of the investigator, his/her family members, employees and other dependent persons **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Thomas Pabst, Prof. **Phone:** +41 31 632 84 30 **Role:** CONTACT #### Locations **Location 1:** **City:** Bern **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Thomas Pabst, Prof. - **Phone:** 0041316328430 - **Role:** CONTACT **Country:** Switzerland **Facility:** Insel Gruppe AG **State:** BE **Zip:** 3010 #### Overall Officials **Official 1:** **Affiliation:** Insel Gruppe AG Bern Switzerland **Name:** Thomas Pabst, Prof. **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Access Criteria:** email contact: [email protected] **Info Types:** - STUDY_PROTOCOL - SAP - ICF **IPD Sharing:** YES **Time Frame:** 24 months ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000008206 - Term: Lymphatic Diseases - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases - ID: D000006402 - Term: Hematologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10945 - Name: Leukemia - Relevance: HIGH - As Found: Leukemia - ID: M11220 - Name: Lymphoma - Relevance: HIGH - As Found: Lymphoma - ID: M12058 - Name: Multiple Myeloma - Relevance: LOW - As Found: Unknown - ID: M27588 - Name: Neoplasms, Plasma Cell - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: T3543 - Name: Lymphosarcoma - Relevance: LOW - As Found: Unknown - ID: T3947 - Name: Multiple Myeloma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008223 - Term: Lymphoma - ID: D000007938 - Term: Leukemia ### Intervention Browse Module - Browse Branches - Abbrev: Antipy - Name: Antipyretics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M29176 - Name: Antipyretics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430723 **Brief Title:** The Impact of Obesity on Short Stem Total Hip Arthroplasty **Official Title:** Obesity and it's Impact on Subsidence and Clinical Outcomes After Short Stem Total Hip #### Organization Study ID Info **ID:** EK 1258/2023 #### Organization **Class:** OTHER **Full Name:** Krankenhaus Barmherzige Schwestern Linz ### Status Module #### Completion Date **Date:** 2024-01-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-12-31 **Type:** ACTUAL #### Start Date **Date:** 2018-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Krankenhaus Barmherzige Schwestern Linz #### 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 purpose of this study is to review the impact of obesity on subsidence and clinical outcome after short stem total hip arthroplasty. **Detailed Description:** Short stem total hip arthroplasty (THA) has gained popularity due to its bone-sparing technique, but its outcomes in obese patients remain uncertain. While studies on the mid-term outcome in a general patient cohort provide excellent results in terms of the clinical and radiological outcome as well as the complication rate of short stem THA, data on its use in obese patients is still rare and not sufficiently conclusive. Some studies have found no evidence of increased subsidence in obese patients, while other studies have shown contrary trends. In this context, the aim of this study was to investigate the relationship between BMI, postoperative subsidence and clinical outcomes in the setting of short stem THA. ### Conditions Module **Conditions:** - THA - Obesity **Keywords:** - subsidence - obesity - short stem total hip arthroplasty - tha ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 216 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Body mass index \< 30 kg/m2 **Intervention Names:** - Procedure: Total hip arthroplasty **Label:** Non-obese #### Arm Group 2 **Description:** Body mass index \>= 30 kg/m2 **Intervention Names:** - Procedure: Total hip arthroplasty **Label:** Obese ### Interventions #### Intervention 1 **Arm Group Labels:** - Non-obese - Obese **Description:** Total hip arthroplasty using short stem via an minimally invasive anterolateral approach **Name:** Total hip arthroplasty **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** subsidence of the short stem measured via EBRA (Einzelbild Röntgenanalyse), \[mm\] **Measure:** Subsidence **Time Frame:** 2 years **Description:** Clinical outcome, \[0-100points\] **Measure:** Harris Hip Score **Time Frame:** 2 years #### Secondary Outcomes **Description:** Surgery time from cut to skin closure, \[minutes\] **Measure:** surgery time **Time Frame:** 2 years **Description:** Length of postoperative stay in hospital \[days\] **Measure:** Length of stay **Time Frame:** 2 years **Description:** Blood loss calculated according to laboratory test results of hematocrit \[ml\] **Measure:** Blood loss **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. patients who underwent primary short stem hip arthroplasty with Mathys Optimys short stem between 01.01.2018 and 31.12.2020 2. availability of preoperative and postoperative radiographs for assessment of subsidence 3. a minimum BMI of 30kg/m2 for the obese group 4. a minimum follow-up of 24 months. Exclusion Criteria: 1. former surgeries of the hip in question 2. incomplete clinical data 3. incomplete radiological data **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The purpose of this study was to assess the subsidence rates in patients who underwent short stem hip arthroplasty and its association with obesity. To investigate this, an analysis of patient data was conducted together with a follow-up examination, focusing on clinical outcome and radiographic analysis of the subsidence of the stem in obese patients. Hence, two groups based on body mass index were retrospectively evaluated: obese (BMI ≥ 30 kg/m\^2) and non-obese (BMI \< 30 kg/m\^2), with an age of minimum 18 years, but no maximum age. ### Contacts Locations Module #### Locations **Location 1:** **City:** Linz **Country:** Austria **Facility:** Ordensklinikum Linz, Barmherzige Schwestern Abteilung Orthopädie **Zip:** 4010 ### IPD Sharing Statement Module **IPD Sharing:** NO ## 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: 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 ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430710 **Brief Title:** Tooth Borne Versus Temporary Anchorage Devices (TAD) Based Intrusion Systems for the Correction of Anterior Deep Overbite **Official Title:** Tooth Borne Versus Temporary Anchorage Devices Based Intrusion Systems for the Correction of Anterior Deep Overbite;Oral Hygiene, Pain and Treatment Effect #### Organization Study ID Info **ID:** ORTHO-109-2H #### Organization **Class:** OTHER_GOV **Full Name:** Faculty of Dental Medicine for Girls ### Status Module #### Completion Date **Date:** 2024-03-27 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-02-02 **Type:** ACTUAL #### Start Date **Date:** 2022-09-25 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Faculty of Dental Medicine for Girls #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Compare the tooth borne versus fixed orthodontic intrusive system (TADs) for the correction of anterior deep overbite **Detailed Description:** this study determined which method was more compliant, efficacy and comfortable. It was performed to evaluate intrusion of upper incisors with applying tooth borne system as Connecticut Intrusion Arch (CIA) and temporary anchorage devices (TADs) \[miniscrew\] and evaluate the dental and skeletal cephalometric effects of these intrusion methods on individuals with deep bite caused by supraocclusion of upper incisors. It also evaluated oral hygiene and pain sensation in the two groups during the study period. ### Conditions Module **Conditions:** - Deep Overbite **Keywords:** - Anterior deep bite - Intrusive arch - Miniscrews ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Sixteen patients with anterior deep over bite participated in two groups each group contains eight patients ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 16 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Miniscrews for incisor intrusion **Intervention Names:** - Device: Intrusion **Label:** Mninscrew **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Continuous arch technique for incisor intrusion **Intervention Names:** - Device: Intrusion **Label:** Intrusive arch **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intrusive arch - Mninscrew **Description:** 2 different methods for incisor intrusion **Name:** Intrusion **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** measure in mm the distance of apical movement **Measure:** Measure distance of insicors intrusion **Time Frame:** 2 years #### Secondary Outcomes **Description:** By unit on Visual Analogue Scale **Measure:** Pain intensity **Time Frame:** 8 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Class I or Class II malocclusion with minimal crowding. 2. 70% to 100% overbite. 3. High lip line with gingival display on smiling and super-eruption of maxillary incisors. 4. All patients had permanent dentition with average to vertical growth pattern and curve of Spee of 4mm or less. Exclusion Criteria: 1. Having missing teeth on the anterior maxillary area. 2. Any history of trauma or root canal treatment. 3. Previous orthodontic treatment. 4. Low lip line duing social smile. 5. Having any hormonal disorder or syndromes. **Healthy Volunteers:** True **Maximum Age:** 22 Years **Minimum Age:** 15 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Al-Azhar University ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008310 - Term: Malocclusion - 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: M28896 - Name: Overbite - Relevance: HIGH - As Found: Overbite - ID: M11303 - Name: Malocclusion, Angle Class II - Relevance: HIGH - As Found: Overbite - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M11301 - Name: Malocclusion - 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: D000057887 - Term: Overbite - ID: D000008312 - Term: Malocclusion, Angle Class II ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430697 **Acronym:** PAREA **Brief Title:** Hemodynamic Impact of the Administration of PAracetamol in Patients Hospitalized in the Intensive Resuscitation Medicine Department [PAREA] **Official Title:** Prospective Study Evaluating the Hemodynamic Impact of PAracetamol Administration in Patients Hospitalized in the REAnimation Intensive Care Unit #### Organization Study ID Info **ID:** 22-AOI-13 #### Organization **Class:** OTHER **Full Name:** Centre Hospitalier Universitaire de Nice ### Status Module #### Completion Date **Date:** 2027-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **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:** Centre Hospitalier Universitaire de Nice #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Paracetamol is commonly used in case of pain or fever. Few previously clinical studies has highlighted an arterial hypotension linked to intravenous administration of paracetamol. Currently, fewer data are available on the link of intravenous administration of paracetamol and effects on arterial tension. The aim of this study is to describe the frequency of occurrence of significative arterial hypotension within one hour following intravenous or per os administration of paracetamol . Other factors who can be associated to occurence of significative arterial hypotension will be also observe (for example age, weight, pain, vasopressor dosage or sedative...) ### Conditions Module **Conditions:** - Intensive Care Unit Syndrome **Keywords:** - Intensive Care Unit - PARACETAMOL - blood pressure ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: paracetamol administration **Label:** Treatment with paracetamol **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment with paracetamol **Description:** Patient hospitalized in Intensive Care Unit with a continuous measurement of blood pressure with a catheter and who have an administration of paracetamol by intravenous or per os **Name:** paracetamol administration **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Proportion of patients with clinically significant low blood pressure occurring within one hour of administration of paracetamol IV or per os. Clinically significant low blood pressure is defined as an average blood pressure of less than 60 mmHg and/or a decrease in average blood pressure of more than 15%, and/or need for vascular filling and/or initiation or increase of the dose of noradrenaline **Measure:** Measure frequency of low blood pressure following paracetamol administration **Time Frame:** One hour after administration of paracetamol #### Secondary Outcomes **Description:** Identify patients' predictors of low blood pressure following paracetamol administration : Patients' will be identified by measuring frequency of patients with low blood pressure following paracetamol administration, according to The IGS II score (Simplified Severity Index II) is a score used to assess the severity of a patient and is one of the scores used in intensive care and SOFA score. Components: The IGS II includes several variables, such as age, chronic health conditions, vital signs, and laboratory values. These factors are combined to calculate a numerical score. Scoring: The higher the IGS II score, the greater the predicted risk of mortality. The score ranges from 0 to 100, with higher values indicating more severe illness. **Measure:** Measure of blood pressure following paracetamol administration according to IGS II score **Time Frame:** One hour after administration of paracetamol **Description:** Measure of blood pressure to identify predictors by measuring frequency of patients with low blood pressure following paracetamol administration, according to administration's route **Measure:** identify predictors linked to paracetamol administration route **Time Frame:** One hour after administration of paracetamol **Description:** Measure of blood pressure to identify predictors by measuring frequency of patients with low blood pressure following paracetamol administration, according to dosage **Measure:** identify predictors linked to paracetamol dosage **Time Frame:** One hour after administration of paracetamol **Description:** Identify patients' predictors of low blood pressure following paracetamol administration : Patients' will be identified by measuring frequency of patients with low blood pressure following paracetamol administration, according to the SOFA score. The sequential organ failure assessment score (SOFA score), previously known as the sepsis-related organ failure assessment score,is used to track a person's status during the stay in an intensive care unit (ICU) to determine the extent of a person's organ function or rate of failure. Each system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). The worst physiological variables are collected serially every 24 hours of a patient's ICU admission12. The total SOFA score ranges from 0 (best) to 24 (worst) points. It's a valuable tool for predicting clinical outcomes in critically ill patients **Measure:** Measure of blood pressure following paracetamol administration according to SOFA score **Time Frame:** One hour after administration of paracetamol ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Inclusion: * 18 years of age or older * Patient with arterial catheter * Indication of paracetamol's administration by the patient's attending practitioner. * No opposition to patient or support person participation in the study if the patient is unable to participate ExclusionCriteria: * No Social Security Patient * Pregnant or nursing patient. * Patient with a legal protection measure * Hypersensitivity and/or allergy to paracetamol. * Contraindication to the use of paracetamol. * Patient opposition to health data collection. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Kamila BURDZENIDZE, Study nurse **Phone:** 04 92 03 92 20 **Role:** CONTACT #### Locations **Location 1:** **City:** Nice **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Kamila BURDZENIDZE, Study nurse - **Phone:** 04 92 03 92 20 - **Role:** CONTACT ***Contact 2:*** - **Name:** Kamila BURDZENIDZE - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** CHU de NICE ARCHET **Zip:** 06000 ## 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: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - 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: D000058633 - Term: Antipyretics ### Intervention Browse Module - Browse Branches - Abbrev: Antipy - Name: Antipyretics - Abbrev: Analg - Name: Analgesics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M2340 - Name: Acetaminophen - Relevance: HIGH - As Found: Endoscopic - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M20786 - Name: Analgesics, Non-Narcotic - Relevance: LOW - As Found: Unknown - ID: M29176 - Name: Antipyretics - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000082 - Term: Acetaminophen ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430684 **Acronym:** SGLT2I-IN-KIDS **Brief Title:** Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease **Official Title:** Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease #### Organization Study ID Info **ID:** SGLT2I-IN-KIDS #### Organization **Class:** OTHER **Full Name:** Ann & Robert H Lurie Children's Hospital of Chicago #### Secondary ID Infos **ID:** K23DK138313 **Link:** https://reporter.nih.gov/quickSearch/K23DK138313 **Type:** NIH ### Status Module #### Completion Date **Date:** 2028-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) #### Lead Sponsor **Class:** OTHER **Name:** Ann & Robert H Lurie Children's Hospital of Chicago #### Responsible Party **Investigator Affiliation:** Ann & Robert H Lurie Children's Hospital of Chicago **Investigator Full Name:** Alexander Kula **Investigator Title:** Assistant Professor of Pediatrics (Nephrology) **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this study is to learn if a clinical trial of sodium-glucose co-transporter 2 inhibitors (SGLT2i) is possible in youth with chronic kidney disease (CKD). The investigators also plan to explore whether treatment with SGLT2i (Empagliflozin) helps improve risk factors for worsening kidney and heart disease. The main questions are: 1. Is enrolling 40 youth with CKD into a clinical trial of empagliflozin feasible (ie achievable)? 2. Does taking empagliflozin for 3 months result in positive changes in blood, urine, and heart function tests? Participants will be randomly selected (like flipping a coin) to either receive empagliflozin or not start treatment with empagliflozin and remain on their usual care. Study Procedures Include * For participants randomly selected for treatment, take empagliflozin once daily for 3 months * Phone calls with researchers every 2 weeks for check-ins * For participants taking empagliflozin, clinic visits 4 and 8 weeks after starting for check-ups and tests * All study participants will have clinic visits at the beginning and end (3 months) where researchers will collect information about their health and perform tests ### Conditions Module **Conditions:** - Chronic Kidney Diseases - Pediatric Kidney Disease **Keywords:** - Sodium Glucose Co-Transporter 2 Inhibitor - SGLT2i - Pediatric CKD - Feasibility Study - Clinical Trial ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Empagliflozin 10mg daily for 3 months (n=20) **Intervention Names:** - Drug: Empagliflozin 10 MG **Label:** Treatment **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will not take empagliflozin (n=20) **Label:** Standard of Care **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment **Description:** Empagliflozin is a sodium glucose co-transporter 2 inhibitor (SGLT2i) that is approved for the treatment of chronic kidney disease (CKD) in persons aged 18 years or older **Name:** Empagliflozin 10 MG **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Compared to the number recruited, how many participants complete the study **Measure:** Percentage of participants who complete all study procedures **Time Frame:** 4 years #### Secondary Outcomes **Description:** In-clinic systolic blood pressure **Measure:** Systolic Blood Pressure **Time Frame:** 3 months **Measure:** Serum N-terminal pro-brain natruetic peptide (NT-proBNP) **Time Frame:** 3 months **Measure:** Urine Albumin to Creatinine Ratio (UACr) **Time Frame:** 3 months **Description:** Measuring using echocardiography **Measure:** Left Atrial Reservoir Strain **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Stage 3-4 CKD; estimated GFR using CKiD U25-creatinine equation 20-60mL/min/1.73m2 Exclusion Criteria: * Heart Disease * Diabetes * Pregnancy * Recipient of solid organ transplant * history of chemotherapy or stem cell transplant * moderate to severe persistent asthma * liver disease * class 2 or greater obesity * inability to follow study procedures due to cognitive impairment * obstructive uropathy or requirement for intermittent urinary catheterization * systolic blood pressure \<100mgHg * orthostatic hypotension * current use of an SGLT2i * anticipated need for titration of anti-hypertensives within 3 months * active use of any immunosuppressive medications * lack of clearance by primary nephrologist for participation **Maximum Age:** 25 Years **Minimum Age:** 12 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Alexander J Kula, MD, MHS **Phone:** 312-227-6160 **Role:** CONTACT #### Locations **Location 1:** **City:** Chicago **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Alexander J Kula, MD, MHS - **Phone:** 312-227-6160 - **Role:** CONTACT **Country:** United States **Facility:** Ann & Robert H. Lurie Children's Hospital of Chicago **State:** Illinois **Zip:** 60611 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000051437 - Term: Renal Insufficiency - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: HIGH - As Found: Kidney Disease - ID: M26717 - Name: Renal Insufficiency, Chronic - Relevance: HIGH - As Found: Chronic Kidney Disease - ID: M26718 - Name: Renal Insufficiency - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: 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: D000007674 - Term: Kidney Diseases - ID: D000051436 - Term: Renal Insufficiency, Chronic ### 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 ### Intervention Browse Module - Browse Leaves - ID: M258082 - Name: Empagliflozin - Relevance: HIGH - As Found: At home - 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: C000570240 - Term: Empagliflozin ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430671 **Acronym:** RED4MS **Brief Title:** Peptide-coupled Red Blood Cells for the Treatment of Multiple Sclerosis **Official Title:** Multicenter, Phase Ib/IIa Study on the Safety and Efficacy of Autologous Peptide-coupled Red Blood Cells in Patients With Relapsing Remitting Multiple Sclerosis - RED4MS Trial #### Organization Study ID Info **ID:** MSB-IG-H-2101 #### Organization **Class:** INDUSTRY **Full Name:** Cellerys AG ### Status Module #### Completion Date **Date:** 2027-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **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:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Novartis **Class:** INDUSTRY **Name:** Scope International AG **Class:** INDUSTRY **Name:** Tetec AG **Class:** INDUSTRY **Name:** Jung Diagnostics GmbH #### Lead Sponsor **Class:** INDUSTRY **Name:** Cellerys AG #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** RED4MS is a clinical trial to assess the safety, tolerability and efficacy of autologous peptide coupled red blood cells (CLS12311) in patients with relapsing remitting multiple sclerosis (RRMS). CLS12311 consists of autologous red blood cells (RBCs) chemically coupled with antigenic peptides and aims to treat RRMS by induction of antigen-specific immune tolerance. **Detailed Description:** The RED4MS trial is designed as a combination of a phase Ib (part A) and a phase IIa (part B) study. Part A is an open-label, dose-escalation study, enrolling 9 RRMS patients in three ascending dose groups. The first patient (sentinel) in each dose group will receive one cycle of the therapy, while the remaining patients will receive two treatment cycles. Part B is a baseline-to-treatment, dose-blinded, randomized study and is designed to test the safety and efficacy of three different doses of CLS12311. During baseline phase, a total of 45 patients with active disease on magnetic resonance imaging (MRI) will be selected for the treatment phase and randomized in a 1:1:1 ratio into one of three dosing groups. Each patient will receive two cycles of therapy. ### Conditions Module **Conditions:** - Relapsing-remitting Multiple Sclerosis (RRMS) ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Individual patients will be assigned to three parallel dose groups. In Part A patients will be allocated in the low, medium, high dose group according to the order of recruitment. In Part B patients will be randomized in a ratio 1:1:1 into one of the three dosing groups. ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** Part A is an open label Phase I trial Part B is randomized, dose-blinded Phase II trial **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 135 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Low dose CLS12311 **Intervention Names:** - Drug: CLS12311 low - Drug: uncoupled RBCs **Label:** CLS12311 low **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Medium dose CLS12311 **Intervention Names:** - Drug: CLS12311 medium - Drug: uncoupled RBCs **Label:** CLS12311 medium **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** High dose CLS12311 **Intervention Names:** - Drug: CLS12311 high **Label:** CLS12311 high **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - CLS12311 low **Description:** Peptide-coupled Red Blood Cells (RBCs) **Name:** CLS12311 low **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - CLS12311 medium **Description:** Peptide-coupled Red Blood Cells (RBCs) **Name:** CLS12311 medium **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - CLS12311 high **Description:** Peptide-coupled Red Blood Cells (RBCs) **Name:** CLS12311 high **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - CLS12311 low - CLS12311 medium **Description:** autologous Red Blood Cells (RBCs) **Name:** uncoupled RBCs **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Number and severity of adverse events (AEs) and serious adverse events (SAEs) and worsening of disease measured by clinical (relapses) and imaging (number \& size of brain MRI lesions) **Measure:** Incidence of treatment-related adverse events as assessed by CTCAE v4.0 and worsening of MS [Safety of CLS12311] **Time Frame:** on average 48 weeks **Description:** The cumulative number of new brain lesions on the MRI scans developed in the post-treatment phase during weeks 16-24 compared to pre-treatment number of new brain lesions developed during weeks -8 and 0 for any dose **Measure:** Overall reduction in the number of new brain lesions in treatment phase vs. pre-treatment phase [Efficacy of CLS12311] **Time Frame:** completion of treatment phase, on average 24 weeks #### Secondary Outcomes **Description:** Number and severity of treatment-emergent AEs (TEAEs) and treatment-emergent SAEs (TESAEs) in each dose group **Measure:** Incidence of treatment-related adverse events as assessed by CTCAE v4.0 in each dose group [Safety of CLS12311] **Time Frame:** on average 48 weeks **Description:** Number of confirmed relapses in the treatment phase in each dose group **Measure:** Incidence of patients experiencing worsening of MS in each dose group [Safety of CLS12311] **Time Frame:** on average 48 weeks **Description:** Change in Expanded Disability Status Scale (EDSS) in each dose group **Measure:** Incidence of patients experiencing worsening of EDSS in each dose group [Safety of CLS12311] **Time Frame:** on average 48 weeks **Description:** Change in Timed 25-Foot Walk (T25-FW) in each dose group **Measure:** Incidence of patients experiencing worsening of T25-FW in each dose group [Safety of CLS12311] **Time Frame:** on average 48 weeks **Description:** Change in 9-Hole Peg Test (9-HPT) in each dose group **Measure:** Incidence of patients experiencing worsening of 9-HPT in each dose group [Safety of CLS12311] **Time Frame:** on average 48 weeks **Description:** Change in Symbol Digit Modalities Test (SDMT) in each dose group **Measure:** Incidence of patients experiencing worsening of SDMT in each dose group [Safety of CLS12311] **Time Frame:** on average 48 weeks **Description:** Number of new lesions on brain MRI in weeks 16-24 in each dose group **Measure:** Efficacy of CLS12311 in reducing number of new brain lesions as a surogate for inflammatory disease activity **Time Frame:** completion of treatment phase, on average 24 weeks **Description:** Number of new brain lesions in defined subgroups, stratified for HLA or immunological parameters through the treatment phase **Measure:** Efficacy of CLS12311 in reducing the number of new brain lesions in defined subgroups **Time Frame:** completion of treatment phase, on average 24 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria (Part A and B): 1. RRMS according to the 2017 McDonald criteria 2. Male or female patients (assigned at birth) aged 18-55 years inclusive 3. Disease duration (since diagnosis) \<10 years 4. Expanded Disability Status Scale (EDSS) at baseline 0-5.5 5. ≥1 relapse or new CEL/T2 in previous 12 months (only Part B) 6. Untreated patients or patients being off therapy for the time-periods listed under exclusion criterion No. 2. Patients are either not eligible to receive approved therapies or have explicitly chosen not to receive such therapies after being adequately informed by the investigators 7. Only for female patients of childbearing potential (sexually mature, pre-menopausal and not surgically sterile): the patient is willing to use a highly effective method of contraception throughout the treatment phase or at least for 4 weeks after the last dose of the study drug 8. Male patients willing to use contraception (such as a condoms) throughout the treatment phase or at least for 4 weeks after the last dose of the study drug, unless surgically steril Exclusion Criteria (Part A and B): 1. Patients with an active chronic disease (or stable but treated with immunomodulatory/-suppressive therapy) of the immune system other than MS (e.g. rheumatoid arthritis, scleroderma, Crohn's disease, ulcerative colitis, etc.) or with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug-induced immune deficiency) 2. Prior treatment with any of the medications specified in the protocol 3. History of HIV, chronic or active Hepatitis, chronic or active Hepatitis B or Syphilis 4. Long-Covid19 syndrome 5. History of splenectomy or chronic liver disease 6. History of coronary artery disease, chronic heart failure, aortic stenosis 7. Current anticoagulation therapy 8. Uncontrolled grade II hypertension (≥160 systolic and/or ≥100 diastolic blood pressure according to the International Society of Hypertension (ISH) guidelines) despite treatment or without treatment 9. History of stroke 10. Pregnant female confirmed by a positive pregnancy test or breast-feeding 11. History of alcohol or drug abuse within the 1 year prior to screening visit 1 12. History of or existing malignancy within the last 5 years prior to enrolment except history of basal cell carcinoma and melanoma in situ 13. History of or existing relevant central nervous system disorder (other than MS) 14. Allergy to gadolinium-based contrast agents 15. Any other disease or condition, which could interfere with the participation in the study according to the study protocol, or with the ability of the patients to cooperate and comply with the study procedures. 16. Anemia, defined as hemoglobin levels ≤12.5 g/dl (7.25 mmol/l) for female and ≤13.5 g/dl (8.37 mmol/l) for male participants (may be repeated if 11.5-12.5 g/dl in females and 12.5-13.5 g/dl in males) 17. Erythrocyte count \<4.0 E12/L in female and \<4.5 E12/L in male patients (may be repeated if \>3.8 E12/L in female and \>4.3 E12/L in male) 18. Lymphopenia with total lymphocyte counts ≤1000/µl (may be repeated if \>800/µl) 19. Positive HIV testing 20. Positive results of baseline period testing for serological markers for hepatitis B, C, and Syphilis indicating acute or chronic infection 21. Patient is not eligible for blood donation according to local regulations 22. Having one or more of the following laboratory results: 1. Estimated glomerular filtration rate (eGFR)\< 60 mL/min/1.73 m2 (may be repeated if eGFR 45-59 mL/min/1.73 m2) 2. ALT or AST \>3x upper limit of normal (ULN; may be repeated if 3.1-4x ULN) 3. Total bilirubin greater than 2x ULN (may be repeated if 2.1-3x ULN), with the exception for patients with Gilbert's disease 4. Platelet count ≤100x109/L (may be repeated if 80-100x 109/L) 5. Abnormalities in hepatic synthetic function tests as judged by the Investigator to be clinically significant **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Andreas Lutterotti, MD **Phone:** +41 41 544 98 80 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Nathalie Fournichot **Phone:** +41 41 544 98 80 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000020278 - Term: Demyelinating Autoimmune Diseases, CNS - ID: D000020274 - Term: Autoimmune Diseases of the Nervous System - ID: D000009422 - Term: Nervous System Diseases - ID: D000003711 - Term: Demyelinating Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M12060 - Name: Multiple Sclerosis - Relevance: HIGH - As Found: Multiple Sclerosis - ID: M15415 - Name: Sclerosis - Relevance: HIGH - As Found: Sclerosis - ID: M22314 - Name: Multiple Sclerosis, Relapsing-Remitting - Relevance: HIGH - As Found: Relapsing Remitting Multiple Sclerosis - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M22098 - Name: Demyelinating Autoimmune Diseases, CNS - Relevance: LOW - As Found: Unknown - ID: M22094 - Name: Autoimmune Diseases of the Nervous System - Relevance: LOW - As Found: Unknown - ID: M6909 - Name: Demyelinating Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009103 - Term: Multiple Sclerosis - ID: D000020529 - Term: Multiple Sclerosis, Relapsing-Remitting - ID: D000012598 - Term: Sclerosis ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430658 **Acronym:** NEXUS-2 **Brief Title:** Neoadjuvant Comprehensive Treatment for Unresectable Esophageal Cancer **Official Title:** NEoadjuvant Total rX for Borderline Unresectable Esophageal Squamous Cell Carcinoma: a Prospective Randomized, Three-Arm, Open-Label Phase II Trial (NEXUS-2) #### Organization Study ID Info **ID:** NEXUS-2 #### Organization **Class:** OTHER **Full Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences ### Status Module #### Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences #### Responsible Party **Investigator Affiliation:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences **Investigator Full Name:** YIN LI **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:** Patients diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) that is deemed unresectable face a bleak prognosis. Recent phase 1/2 studies have demonstrated the efficacy and safety of augmenting neoadjuvant concurrent chemoradiotherapy with immunotherapy in treating resectable ESCC. The present study is a prospective, 3-arm, randomized trial that seeks to evaluate the efficacy of diverse conversion therapy modalities in patients with unresectable ESCC. The study objectives include R0 resection rate, treatment-related adverse events, morbidity and mortality, 1-year progression-free survival (PFS), and 1-year overall survival (OS) rates. Tislelizumab is a humanized IgG4 monoclonal antibody with high affinity/specificity for programmed cell death protein 1 (PD-1). Tislelizumab was specifically engineered to minimize binding to FcɤR on macrophages, thereby abrogating antibody-dependent phagocytosis, a potential mechanism of T-cell clearance and resistance to anti-PD-1 therapy. This trial will provide valuable insights into the effectiveness of the three conversion therapy modalities and help to inform clinical decision-making for patients with unresectable locally advanced ESCC. ### Conditions Module **Conditions:** - Esophagus Cancer **Keywords:** - Esophagus Cancer - Chemoradiotherapy - conversion surgery - immunotherapy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Surgery was evaluated after chemoradiotherapy (40-41.4Gy/1.8-2Gy/20-23 fractions) followed by two cycles of chemotherapy and immunotherapy **Intervention Names:** - Combination Product: Tislelizumab (BGB-A317) with chemoradiotherapy **Label:** ChemoRT+Immuno **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Surgery was evaluated after two cycles of chemotherapy and immunotherapy followed by chemoradiotherapy(40-41.4Gy/1.8-2Gy/20-23 fractions) **Intervention Names:** - Combination Product: Tislelizumab (BGB-A317) with chemoradiotherapy **Label:** Immuno+ChemoRT **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Surgery was evaluated after concurrent definitive chemoradiotherapy (50-50.4Gy/1.8-2Gy/25-28fractions) and immunotherapy. **Intervention Names:** - Combination Product: Tislelizumab (BGB-A317) with chemoradiotherapy **Label:** ChemoRT **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - ChemoRT - ChemoRT+Immuno - Immuno+ChemoRT **Description:** Different sequences and methods of treatment to convert surgery **Name:** Tislelizumab (BGB-A317) with chemoradiotherapy **Type:** COMBINATION_PRODUCT ### Outcomes Module #### Primary Outcomes **Description:** Minimal distance tumor/circumferential resection margin (CRM) \> 1 mm. **Measure:** R0 resection rate **Time Frame:** 4 months #### Secondary Outcomes **Description:** Defined as the proportion of patients still alive within one year from treatment initiation. **Measure:** 1-year OS rate **Time Frame:** 1 year after all treatment **Description:** Defined as the proportion of patients without disease progression or death within one year from treatment initiation. **Measure:** 1-year PFS **Time Frame:** 1 year after all treatment **Description:** To investigate whether ctDNA variation can be used for MRD monitoring in patients with unresectable locally advanced ESCC. **Measure:** Efficacy of circulating tumor DNA (ctDNA) in minimal residual disease (MRD) monitoring **Time Frame:** 6 month **Description:** Adverse event during chemoRT or immunotherapy **Measure:** Safety profile **Time Frame:** 4 month **Measure:** Pathological response **Time Frame:** 4 month **Measure:** Postoperative complications **Time Frame:** 4 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Histologically confirmed sorely ESCC without other histology subtypes. 2. Thoracic esophageal cancer. 3. No prior anti-cancer treatment, including but not limited to surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy. 4. Borderline unresectable locally advanced ESCC deemed by investigators as suspicious of but not confirmed T4b according to the American Joint Committee on Cancer (AJCC) 8th edition staging classification or extracapsular lymph node involvement (ELNI). 5. The Karnofsky Performance Scale (KPS) ≥70. 6. Normal primary organ functions, including but not limited to hemoglobin (Hb) ≥ 100g/L; white blood cell (WBC) ≥ 3.5×10\*9/L; neutrophil count (NEUT) ≥ 1.5×10\*9/L; platelets (PLT) ≥ 100×10\*9/L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5×UNL; total bilirubin (TBIL) ≤ 1.5×UNL; creatinine ≤ 1.5UNL; blood urea nitrogen (BUN) ≤ 1.0×UNL. Exclusion Criteria: 1. Synchronous and metachronous primary malignancies in but not limited to the upper aerodigestive tract, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix. 2. Patients have undergone any type of anti-cancer treatment. 3. Baseline clinical stage M1 per AJCC 8th edition of staging classification, including supraclavicular lymph node metastases. 4. Investigators assessed major vessel involvement with high-risk hemorrhage. 5. A higher probability of esophageal perforation during conversion therapy. 6. Active infectious diseases, including but not limited to tuberculosis, hepatitis B virus, or hepatitis C virus. 7. Allergic to anti-cancer agents, including but not limited to anti-PD-1 or chemotherapy agents. 8. Given cardiopulmonary dysfunction, patients can not tolerate conversion therapy or surgery. 9. Pregnant or lactating women and women of childbearing potential who lacked effective contraception. 10. Non-compliance with the inclusion criteria judged by investigators. **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:** Xin Wang, Doctor **Phone:** 13311583220 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Ziyu Zheng, B.M **Phone:** 13552252161 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Xin Wang, MD - **Phone:** +861013311583220 - **Role:** CONTACT **Country:** China **Facility:** Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) **Status:** RECRUITING **Zip:** 100021 ## 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: 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: LOW - As Found: Unknown - ID: M5550 - Name: Carcinoma, Squamous Cell - Relevance: LOW - As Found: Unknown - ID: M1733 - Name: Esophageal Squamous Cell Carcinoma - Relevance: LOW - As Found: Unknown - ID: M8088 - Name: Esophageal Neoplasms - Relevance: HIGH - As Found: Esophagus Cancer - 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: HIGH - As Found: Esophagus Cancer ### Condition Browse Module - Meshes - ID: D000004938 - Term: Esophageal Neoplasms ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M137899 - Name: Tislelizumab - Relevance: HIGH - As Found: Intensive Care - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000707970 - Term: Tislelizumab ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430645 **Brief Title:** Effects of Esketamine on Recovery of Consciousness After Propofol Anesthesia **Official Title:** Effects of Esketamine on Recovery of Consciousness After Propofol Anesthesia #### Organization Study ID Info **ID:** esketamine_2024 #### Organization **Class:** OTHER **Full Name:** Beijing Tiantan Hospital ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-10-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-05 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Beijing Tiantan Hospital #### Responsible Party **Investigator Affiliation:** Beijing Tiantan Hospital **Investigator Full Name:** Ruquan Han **Investigator Title:** Director of Anesthesiology Department **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Esketamine is an antagonist of N-methyl-d-aspartate (NMDA) receptor different from other gamma-aminobutyric acid (GABA) receptor agonists. Recent studies showed that subanesthetic doses of ketamine not only deepen anesthesia but also accelerate recovery from isoflurane anesthesia in mice. It is necessary to verify if it applies to human. Besides inducing behavioral unresponsiveness, an optimal and important goal of general anesthesia is to prevent connected consciousness. The results of many studies support the conclusion that anesthesia-related unconsciousness is a consistent functional disconnection of lateral frontoparietal networks.The goal of this clinical trial is to learn if subanaesthetic doses of esketamine works to accelerate the recovery of consciousness from propofol anesthesia. It will also learn about the change of brain network when administrated the esketamine during propofol anesthesia. The main questions it aims to answer are: 1. Does subanaesthetic doses of esketamine can accelerate recovery from propofol anaesthesia? 2. What will happen to brain network connection after different doses of esketamine during propofol anesthesia? ### Conditions Module **Conditions:** - Post-anesthesia Recovery ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Drug：esketamine (0.3mg/kg) **Intervention Names:** - Drug: Esketamine **Label:** low dose of esketamine **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Drug：esketamine(0.6mg/kg) **Intervention Names:** - Drug: Esketamine **Label:** high dose of esketamine **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Drug：0.9% saline **Intervention Names:** - Drug: Saline **Label:** control group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - low dose of esketamine **Description:** Sufentanil(0.1ug/kg) and flurbiprofen axetil(50mg) are administered before induction. Propofol (10 mg/ml) is infused via target-controlled infusions (TCIs). Esketamine hydrochloride (0.3mg/kg total body weight) single intravenous injection after stable plasma concentration of propofol deep sedation. **Name:** Esketamine **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - high dose of esketamine **Description:** Sufentanil(0.1ug/kg) and flurbiprofen axetil(50mg) are administered before induction. Propofol (10 mg/ml) is infused via target-controlled infusions (TCIs). Esketamine hydrochloride (0.6mg/kg total body weight) single intravenous injection after stable plasma concentration of propofol deep sedation. **Name:** Esketamine **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - control group **Description:** Sufentanil(0.1ug/kg) and flurbiprofen axetil(50mg) are administered before induction. Propofol (10 mg/ml) is infused via target-controlled infusions (TCIs). The same volume of 0.9% saline instead of esketamine will be given to the control group after stable plasma concentration of propofol deep sedation. **Name:** Saline **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Recovery time will be defined as the time from terminating propofol administration to opening eyes to verbal stimuli (participants addressed by name) or, if necessary, mild tactile stimuli (a tap in the shoulder) every 30 seconds. **Measure:** Recovery time **Time Frame:** 2 hours #### Secondary Outcomes **Description:** The task includes process-dissociation procedure with the word-stem completion. The value ranges from -1 to 1. If the value is less than or equal to 0, it means no memory. If the value is more than 0, it means memory is detected. **Measure:** Explicit memory scores and implicit memory scores **Time Frame:** 2 hours **Description:** The judges of structured interviews includes three main categories: reports of no recall of any experiences, white reports and reports with specific content. **Measure:** Subjective experience report **Time Frame:** 2 hours **Description:** Time to complete the Grooved Pegboard Test with dominant and non-dominant hand. **Measure:** Grooved Pegboard Test points **Time Frame:** 2 hours **Description:** Processed EEG will be recorded using Sedline (Masimo, Irvine, CA, USA). This includes patients state index (PSI), spectral edge frequency(SEF), and burst suppression duration. **Measure:** Patients state index **Time Frame:** 2 hours **Description:** Processed EEG will be recorded using Sedline (Masimo, Irvine, CA, USA). This includes patients state index (PSI), spectral edge frequency(SEF), and burst suppression duration. **Measure:** Spectral edge frequency **Time Frame:** 2 hours **Description:** Processed EEG will be recorded using Sedline (Masimo, Irvine, CA, USA). This includes patients state index (PSI), spectral edge frequency(SEF), and burst suppression duration. **Measure:** Burst suppression duration **Time Frame:** 2 hours **Description:** Four simultaneous channels of frontal EEG waveforms reflect electrical activity of the frontal and pre-frontal cortices of the brain. **Measure:** Original EEG **Time Frame:** 2 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged from 18 years to 50 years * Patients scheduled for elective operative hysteroscopy * Willing to sign informed consent Exclusion Criteria: * Contraindications of propofol and esketamine * Contraindications for EEG; * ASA≥III; * BMI≥30 kg/m2 or BMI\<18 kg/m2; * The MMSE scale score is lower than the normal value; * Alcohol or drug abuse; * Untreated or under-treated hypertension, hyperthyroidism, risk of increased intracranial pressure, audio-visual impairment, history of psychiatric disorders or neurological diseases, malignant tumors or other major diseases; * Use of other neurological drugs or drugs known to interact with propofol and esketamine in the past 2 weeks; * Pregnant and lactating women; * The operation duration is shorter than 15 minutes or longer than 60 minutes. **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yang Li, Master **Phone:** +86 18810637134 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ruquan Han, Ph.D - **Phone:** 86-13701285393 - **Role:** CONTACT **Country:** China **Facility:** Beijing Tiantan Hospital, Capital Medical University **State:** Beijing **Status:** RECRUITING **Zip:** 100070 #### Overall Officials **Official 1:** **Affiliation:** Beijing Tiantan Hospital **Name:** Ruquan Han, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000000928 - Term: Antidepressive Agents - ID: D000011619 - Term: Psychotropic Drugs ### Intervention Browse Module - Browse Branches - Abbrev: AdjAn - Name: Adjuvants, Anesthesia - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ARhu - Name: Antirheumatic Agents ### Intervention Browse Module - Browse Leaves - ID: M19684 - Name: Sufentanil - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M271980 - Name: Esketamine - Relevance: HIGH - As Found: Hrs - ID: M18307 - Name: Propofol - Relevance: LOW - As Found: Unknown - ID: M8608 - Name: Flurbiprofen - Relevance: LOW - As Found: Unknown - ID: M117729 - Name: Dsuvia - Relevance: LOW - As Found: Unknown - ID: M256863 - Name: Flurbiprofen axetil - Relevance: LOW - As Found: Unknown - ID: M4247 - Name: Antidepressive Agents - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000629870 - Term: Esketamine ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430632 **Acronym:** ERA Stroke **Brief Title:** Early Robotic Gait Training After Stroke **Official Title:** Early Robotic Gait Training After Stroke #### Organization Study ID Info **ID:** 023-471 #### Organization **Class:** OTHER **Full Name:** Baylor Research Institute #### Secondary ID Infos **Domain:** National Institute on Disability, Independent Living, and Rehabilitation Research **ID:** 90IFRE0074 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2026-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** FED **Name:** National Institute on Disability, Independent Living, and Rehabilitation Research #### Lead Sponsor **Class:** OTHER **Name:** Baylor Research Institute #### Responsible Party **Type:** SPONSOR ### 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 ERA Stroke project will compare the effects of robotic gait training (RGT) and usual care (UC) gait training in patients in the subacute phase of stroke recovery undergoing inpatient rehabilitation at the Baylor Scott \& White Institute for Rehabilitation (BSWIR). **Detailed Description:** Importance: Stroke is estimated to affect 6.6 million Americans, and around 795,000 new cases are reported each year. By 2030, annual stroke-related healthcare costs are expected to eclipse $240 billion, a staggering 445% increase from the current annual cost of $53.9 billion. Specialized stroke rehabilitation reduces long-term disability and stroke-related costs, making cost-efficient efforts to minimize functional deficits faced by people with stroke (e.g., gait impairment) a high priority. This project will provision preliminary evidence regarding the clinical use and efficacy of robotic gait training (RGT) during the subacute phase of stroke recovery as well as observational findings associated with the safety, tolerability, feasibility, and cost of delivering RGT during inpatient stroke rehabilitation. Its results will help with developing safe, tolerable, and cost-effective training protocols to improve walking function after stroke. Additionally, follow-up assessments after discharge will investigate any carryover effect of RGT, providing foundational data to evaluate the dose-response relationship for delivering RGT during inpatient rehabilitation after stroke. Altogether, this evidence will help stroke rehabilitation programs to assess their planning and budgeting needs prior to adopting RGT technology, improving outcomes and lowering lifetime care costs for patients with stroke. Aims: (1) Evaluate the safety, tolerability, and feasibility of delivering an RGT intervention that meets the unique needs of people after stroke during inpatient rehabilitation informed by an Advisory Board comprised of stakeholders living with stroke. (2) Examine the efficacy of RGT compared to usual care (UC) gait training during inpatient rehabilitation for people with stroke. (3) Conduct a cost analysis of delivering RGT during inpatient rehabilitation compared to UC. Methods: This randomized controlled trial will enroll 54 patients admitted to the Baylor Scott and White Institute for Rehabilitation following stroke. Participants will be randomized to either the experimental group receiving RGT or the control group receiving UC. Addition to State-of-the-Art: Expected products include a manualized, stakeholder-informed RGT intervention and cost-analysis template that can be replicated across early rehabilitation settings nationally for people with stroke. Sustained Approach: This project builds upon our earlier findings to achieve optimal walking recovery post-stroke during inpatient rehabilitation. The proposed work will generate preliminary efficacy, safety, tolerability, feasibility, and cost-analysis data concerning delivering an RGT intervention during the subacute phase for people with stroke. ### Conditions Module **Conditions:** - Stroke **Keywords:** - Exoskeleton - Gait training - Inpatient rehabilitation - Physical therapy - Physical rehabilitation and medicine - Randomized controlled trial - Robotic gait training ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Participants will be randomized to either the experimental group receiving robotic gait training or the control group receiving usual care gait training. ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 54 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive robotic gait training with a physical therapist for 90 minutes each week throughout the course of their inpatient rehabilitation stay. **Intervention Names:** - Device: Robotic Gait Training **Label:** Robotic Gait Training **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive usual care gait training with a physical therapist for 90 minutes each week throughout the course of their inpatient rehabilitation stay. **Intervention Names:** - Other: Usual Care Gait Training **Label:** Usual Care Gait Training **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Robotic Gait Training **Description:** Participants will complete standing and walking activities while wearing a robotic exoskeleton. Participants will also be asked to complete questionnaires about their walking and function. **Name:** Robotic Gait Training **Other Names:** - EksoNR Robotic Exoskeleton **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Usual Care Gait Training **Description:** Participants will complete standing and walking activities such as body weight-supported treadmill training and conventional overground walking. Participants will also be asked to complete questionnaires about their walking and function. **Name:** Usual Care Gait Training **Other Names:** - Standard of Care Gait Training **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** To supplement the study's measurements of RGT efficacy (10-meter walk test \[gait speed\], 6-minute walk test \[gait endurance\], and Functional Ambulation Category \[gait independence\]), the investigators will additionally measure gait quality. Improvements in quality of gait after a stroke are associated with gains in balance and functional mobility. Further, return to participation in life roles is largely associated with a patients' perspective on their recovery. Therefore, the most impactful way to capture gait quality for each participant will be to use a measure of self-report. Specifically, gait quality will be measured weekly on a visual analog scale from 1 ("my walking is the worst it has ever been") to 10 ("my walking is just like before my stroke"). **Measure:** Gait quality **Time Frame:** weekly until discharge from inpatient rehabilitation (an average of 2 weeks) **Description:** Pain after stroke is common and can result in reduced participation in activity. This change will allow the investigators to monitor the impact of pain on gait outcomes. Pain will be assessed following each RGT and UC session using a pain visual analog scale, as per standard of care in the investigators' inpatient rehabilitation hospital. **Measure:** Pain following each gait training session **Time Frame:** weekly until discharge from inpatient rehabilitation (an average of 2 weeks) **Description:** Number of adverse events occurring at baseline through study completion. **Measure:** Adverse event rate **Time Frame:** through study completion (up to 3.5 months) **Description:** Subjects will provide feedback on their tolerance of treatment sessions via a questionnaire that measures tolerability on a scale 0 (not tolerable at all) to 10 (maximally tolerable). A higher score means greater tolerability in robotic gait training. **Measure:** Treatment tolerability (RGT only) **Time Frame:** weekly until discharge from inpatient rehabilitation (an average of 2 weeks) **Description:** The number of sessions attended divided by the number of scheduled sessions. **Measure:** Treatment completion rate **Time Frame:** through study completion (up to 3.5 months) #### Primary Outcomes **Description:** The 10MWT assesses gait speed over a short duration. Gait speed (m/s) is correlated with ability to mobilize in the community, capacity to perform activities of daily living, and risk of falls, re-hospitalization, and cognitive decline. The 10MWT can be used to categorize individuals according to their ambulatory ability: household ambulators (\<0.4 m/s), limited community ambulators (0.4 to 0.8 m/s), and community ambulators (\>0.8 m/s). Score changes \>0.16 m/s exceed the MCID. Normal gait speed for adults older than 50 years is \>1.27 m/s. **Measure:** Gait speed via 10-Meter Walk Test (10MWT) **Time Frame:** within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation #### Secondary Outcomes **Description:** The FAC assesses functional ambulation in patients undergoing rehabilitation and has excellent reliability, good predictive validity, and good responsiveness in patients with stroke. Scores range from 0 (unable to walk) to 5 (independent walking anywhere). After 4 weeks of rehabilitation, FAC scores ≥4 predict community ambulation at 6 months with 100% sensitivity and 78% specificity. **Measure:** Functional Ambulation Category (FAC) **Time Frame:** within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation **Description:** The Section GG CARE is utilized in post-acute care settings for tracking progress across the continuum of care and is conducted at admission and discharge. The CARE addresses self-care (GG0130, 8 items) and functional mobility (GG0170, 17 items). Scores for each item range from 1 (dependent) to 6 (independent). Total scores for the CARE have strong positive correlations with total scores for the Functional Independence Measure. **Measure:** Continuity Assessment Record and Evaluation (CARE) **Time Frame:** within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation **Description:** The 6MWT assesses distance walked over 6 minutes as a sub-maximal test of walking capacity. Endurance (captured as walking capacity) is essential to participate in community-based activities. With excellent test-retest reliability (ICC = 0.99) for people with stroke, the established MCID is 34.4 meters. **Measure:** 6-Minute Walk Test (6MWT) **Time Frame:** within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation **Description:** The mRS measures the degree of disability or dependence in the daily activities of people who have had a stroke. The mRS is an ordinal scale with 6 categories ranging from 0 (no symptoms) to 5 (complete physical dependence). **Measure:** Modified Rankin Scale (mRS) **Time Frame:** within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation **Description:** The STREAM assesses upper and lower limb motor function along with basic mobility in people with stroke and has a very high inter-rater reliability (ICC = 0.96). MCID values have been established for the upper extremity (2.2 points), lower extremity (1.9 points), and mobility (4.8 points) subscales. **Measure:** Stroke Rehabilitation Assessment of Movement (STREAM) **Time Frame:** within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation **Description:** The 5TSST assesses lower extremity strength and is an indicator of postural control. People with stroke who score \>15 seconds are considered at risk for falls. Normal scores for individuals aged 60-80 years range from 11.4 to 12.7 seconds. The 5TSST has demonstrated excellent test-retest reliability (ICC = 0.95) with an established MDC95 of 2.3 seconds. **Measure:** 5 Times Sit-to-Stand Test (5TSST) **Time Frame:** within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation **Description:** The BBS is a 14-item objective measure that assesses static balance and fall risk in adults. With excellent reliability (ICC = 0.95), the BBS has a large responsiveness for acute stroke (effect size = 0.85) and a minimal detectable change of 6.9 points. Scores \<45/56 indicate a risk of falling. **Measure:** Berg Balance Scale (BBS) **Time Frame:** within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation **Description:** The SIS-16 assesses 4 dimensions of health-related QOLs specific to people who have had a stroke. It includes subscales that assess strength, hand function, mobility, and activities of daily living via 5-point Likert scales. **Measure:** Stroke Impact Scale - 16 (SIS-16) **Time Frame:** within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation **Description:** The Borg RPE is a 15-point scale with verbal descriptors to standardize perceived exertion across tasks and individuals. Participants will be asked to provide a self-reported intensity level on the Borg Rating of Perceived Exertion Scale during RGT and UC gait training sessions. A self-report of 12 to 14 on the RPE indicates moderate intensity. **Measure:** Rating of Perceived Exertion (RPE) **Time Frame:** immediately following every treatment session until discharge from inpatient rehabilitation (an average of 2 weeks) **Description:** The Ekso device records several data points for each session including number of steps, "Up" time (the amount of time spent standing in the device), "Walk" time (the amount of time spent walking in the device), and device assistance scores. While all of these data values will be recorded to describe each RGT session and tracked to monitor progression of the RGT intervention, the number of steps per session will be utilized as an indicator of RGT session intensity. **Measure:** Number of steps (RGT only) **Time Frame:** immediately following every treatment session until discharge from inpatient rehabilitation (an average of 2 weeks) **Description:** Distance walked will be recorded to describe each UC session, tracked to monitor progression of the UC intervention, and utilized as an indicator of UC session intensity. **Measure:** Distance walked (UC only) **Time Frame:** immediately following every treatment session until discharge from inpatient rehabilitation (an average of 2 weeks) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18-85 years of age * All types of stroke * Acute/subacute phase of recovery * Medically stable as deemed by a physician * Undergoing medical care and rehabilitation at BSWIR * All genders, races, and ethnicities * Meets Ekso robotic exoskeleton frame limitations * Continence or on a program for bladder and bowel management * Capacity and goal for walking recovery Exclusion Criteria: * Concurrent neurological diagnoses (e.g., TBI, degenerative, CNS neoplasm) * Profound cognitive impairment * Pregnancy **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:** Sara Baltz, MS **Phone:** (214) 820-5022 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Faith Meza, MPH **Phone:** (214) 820-9409 **Role:** CONTACT #### Locations **Location 1:** **City:** Dallas **Contacts:** ***Contact 1:*** - **Name:** Baylor Scott & White Institute for Rehabilitation - **Role:** CONTACT ***Contact 2:*** - **Name:** Chad Swank, PT, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Baylor Scott & White Institute for Rehabilitation **State:** Texas **Status:** RECRUITING **Zip:** 75246 ### 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:** NCT06430619 **Brief Title:** Can Novel Oxygenation Indices Guide the Diagnosis of Acute Respiratory Distress Syndrome **Official Title:** New Criteria for Classifying Acute Respiratory Distress Syndrome Severity Using a Machine Learning Approach: Novel Oxygenation and Saturation Indices #### Organization Study ID Info **ID:** 2024-40 #### Organization **Class:** OTHER_GOV **Full Name:** Başakşehir Çam & Sakura City Hospital ### Status Module #### Completion Date **Date:** 2024-05-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-02-01 **Type:** ACTUAL #### Start Date **Date:** 2012-06-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi #### Lead Sponsor **Class:** OTHER_GOV **Name:** Başakşehir Çam & Sakura City Hospital #### Responsible Party **Investigator Affiliation:** Başakşehir Çam & Sakura City Hospital **Investigator Full Name:** Furkan Tontu **Investigator Title:** Doctor of Anesthesiology and Reanimation **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study aims to determine the cut-off values of the new oxygenation indices and further investigate their capabilities in diagnosing ARDS and predicting its severity in ICU. Additionally, the investigators aim to compare these results with conventional oxygenation and saturation indices. **Detailed Description:** Recent studies have shown that mechanical power (MP) values below 17 J/min and driving pressure (DP) values below 15 cmH2O reduce intensive care unit (ICU) mortality. Asar et al. have introduced six new oxygenation indices utilizing MP and DP instead of Pmean (OSI-MPtot, OI-MPtot, OSI-ΔPinsp, OI-ΔPinsp, OSI-MPdyn, OI-MPdyn). They compared the predictive abilities of these new indices for ICU mortality in Covid-ARDS (C-ARDS) patients with conventional oxygenation indices (P/F, SpO2/FiO2, OI, OSI, PaO2/(FiO2xPEEP), and SpO2/FiO2xPEEP). OI-ΔPinsp, OSI-ΔPinsp, and OSI-MPdyn indices exhibited the highest predictive power for ICU mortality. However, cut-off values for the diagnosis and severity determination (mild, moderate, and severe) of ARDS patients have not been investigated. In this study, our objective is to determine the cut-off values of the new oxygenation indices and further investigate their capabilities in diagnosing ARDS and predicting its severity in ICU. Additionally, the investigators aim to compare these results with conventional oxygenation and saturation indices. ### Conditions Module **Conditions:** - Respiratory Distress Syndrome, Adult ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 2000 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The oxygenation indexes of the patients will be measured and the effectiveness of these indexes in diagnosing ARDS will be compared. **Label:** Patients diagnosed with Acute Respiratory Distress Syndrome (ARDS) according to Berlin criteria ### Outcomes Module #### Primary Outcomes **Description:** It was aimed to compare the oxygenation indexes of the patients. It will be examined which of these indices is more effective in diagnosing ARDS. **Measure:** Oxygenation indices **Time Frame:** During 28 days in the intensive care unit #### Secondary Outcomes **Description:** It was aimed to compare the sequential organ failure assessment scores of the patients. Score ranges from 0 (best outcome) to 24 (worst outcome) points. **Measure:** Other parameters **Time Frame:** During 28 days in the intensive care unit **Description:** It was aimed to compare the acute physiology and chronic health evaluation-II scores of the patients. Score ranges from 0 (best outcome) to 71 (worst outcome) points. **Measure:** acute physiology and chronic health evaluation-II **Time Frame:** During 28 days in the intensive care unit **Description:** It was aimed to compare the Charlson comorbidity index scores of the patients. Based on the Charlson comorbidity index score, the severity of comorbidity was categorized into three grades: mild, with Charlson comorbidity index scores of 1-2; moderate, with Charlson comorbidity index scores of 3-4; and severe, with Charlson comorbidity index scores ≥5. **Measure:** Charlson comorbidity index scores **Time Frame:** During 28 days in the intensive care unit **Description:** It was aimed to compare the Charlson comorbidity index of the patients. **Measure:** Other parameters **Time Frame:** During 28 days in the intensive care unit **Description:** It was aimed to compare the pH of the patients. **Measure:** arterial blood gas parameters **Time Frame:** During 28 days in the intensive care unit **Description:** It was aimed to compare the base excess of the patients. **Measure:** arterial blood gas parameters **Time Frame:** During 28 days in the intensive care unit **Description:** It was aimed to compare the lactate of the patients. **Measure:** arterial blood gas parameters **Time Frame:** During 28 days in the intensive care unit **Description:** It was aimed to compare the partial oxygen pressure of the patients. **Measure:** arterial blood gas parameters **Time Frame:** During 28 days in the intensive care unit ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients admitted to intensive care units diagnosed with ARDS / C-ARDS according to the Berlin criteria. 2. Adult patients aged between 18 and 80 years Exclusion Criteria: 1. Patients under the age of 18 2. Pregnant patients 3. Patients without ARDS 4. Patients with missing data 5. Patients transferred to another hospital 6. Patients discharged from the ICU within 72 hours 7. Patients receiving extracorporeal membrane oxygenation (ECMO) support. 8. Patients were on mechanical ventilation for less than 24 hours **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients admitted to the intensive care unit of Istanbul Bakırköy Dr. Sadi Konuk Training and Research Hospital with a preliminary diagnosis of ARDS/C-ARDS between June 01, 2012, and February 01, 2024 ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Basaksehir Cam Sakura City Hospital ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** DesPrez K, McNeil JB, Wang C, Bastarache JA, Shaver CM, Ware LB. Oxygenation Saturation Index Predicts Clinical Outcomes in ARDS. Chest. 2017 Dec;152(6):1151-1158. doi: 10.1016/j.chest.2017.08.002. Epub 2017 Aug 16. Erratum In: Chest. 2018 Mar;153(3):768. **PMID:** 28823812 **Citation:** Chen WL, Lin WT, Kung SC, Lai CC, Chao CM. The Value of Oxygenation Saturation Index in Predicting the Outcomes of Patients with Acute Respiratory Distress Syndrome. J Clin Med. 2018 Aug 8;7(8):205. doi: 10.3390/jcm7080205. **PMID:** 30096809 **Citation:** Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639. **PMID:** 25693014 **Citation:** ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669. **PMID:** 22797452 **Citation:** Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291. Erratum In: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350. **PMID:** 26903337 **Citation:** Sayed M, Riano D, Villar J. Novel criteria to classify ARDS severity using a machine learning approach. Crit Care. 2021 Apr 20;25(1):150. doi: 10.1186/s13054-021-03566-w. **PMID:** 33879214 **Citation:** Serpa Neto A, Deliberato RO, Johnson AEW, Bos LD, Amorim P, Pereira SM, Cazati DC, Cordioli RL, Correa TD, Pollard TJ, Schettino GPP, Timenetsky KT, Celi LA, Pelosi P, Gama de Abreu M, Schultz MJ; PROVE Network Investigators. Mechanical power of ventilation is associated with mortality in critically ill patients: an analysis of patients in two observational cohorts. Intensive Care Med. 2018 Nov;44(11):1914-1922. doi: 10.1007/s00134-018-5375-6. Epub 2018 Oct 5. **PMID:** 30291378 **Citation:** Asar S, Rahim F, Rahimi P, Acicbe O, Tontu F, Cukurova Z. Novel Oxygenation and Saturation Indices for Mortality Prediction in COVID-19 ARDS Patients: The Impact of Driving Pressure and Mechanical Power. J Intensive Care Med. 2024 Jun;39(6):595-608. doi: 10.1177/08850666231223498. Epub 2024 Jan 5. **PMID:** 38179691 **Citation:** Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12. **PMID:** 27620287 **Citation:** Asar S, Acicbe O, Cukurova Z, Hergunsel GO, Canan E, Cakar N. Bedside dynamic calculation of mechanical power: A validation study. J Crit Care. 2020 Apr;56:167-170. doi: 10.1016/j.jcrc.2019.12.027. Epub 2020 Jan 2. **PMID:** 31931417 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000012120 - Term: Respiration Disorders - ID: D000007235 - Term: Infant, Premature, Diseases - ID: D000007232 - Term: Infant, Newborn, Diseases - ID: D000055370 - Term: Lung Injury ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14965 - Name: Respiratory Distress Syndrome - Relevance: HIGH - As Found: Respiratory Distress Syndrome - ID: M14964 - Name: Respiratory Distress Syndrome, Newborn - Relevance: HIGH - As Found: Respiratory Distress Syndrome - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M28144 - Name: Acute Lung Injury - Relevance: HIGH - As Found: Respiratory Distress Syndrome, Adult - ID: M28143 - Name: 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: M14957 - Name: Respiration Disorders - 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: M10276 - Name: Infant, Newborn, Diseases - Relevance: LOW - As Found: Unknown - ID: T4927 - Name: Respiratory Distress Syndrome, Infant - Relevance: HIGH - As Found: Respiratory Distress Syndrome - ID: T192 - Name: Acute Respiratory Distress Syndrome - Relevance: HIGH - As Found: Respiratory Distress Syndrome - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012128 - Term: Respiratory Distress Syndrome - ID: D000012127 - Term: Respiratory Distress Syndrome, Newborn - ID: D000055371 - Term: Acute Lung Injury - ID: D000013577 - Term: Syndrome ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430606 **Brief Title:** Novel Oxygenation Indices in Robot-Assisted Laparoscopic Surgeries **Official Title:** How Do Novel Oxygenation Indices Change With Trendelenburg Position in Robot-Assisted Laparoscopic Surgeries? #### Organization Study ID Info **ID:** 2024-05- #### Organization **Class:** OTHER_GOV **Full Name:** Başakşehir Çam & Sakura City Hospital ### Status Module #### Completion Date **Date:** 2024-07-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Başakşehir Çam & Sakura City Hospital #### Responsible Party **Investigator Affiliation:** Başakşehir Çam & Sakura City Hospital **Investigator Full Name:** Furkan Tontu **Investigator Title:** Doctor of Anesthesiology and Reanimation **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** In this study, changes in new oxygenation indices investigated by Asar et al. will be compared with conventional oxygenation and saturation indices in patients undergoing robot-assisted laparoscopic surgery due to pneumoperitoneum and Trendelenburg position. **Detailed Description:** During the intraoperative period, optimal oxygenation should be achieved while avoiding the harmful effects of hypoxia and hyperoxia in patients. The PaO2/FiO2 and SpO2/FiO2 ratios have been traditionally used to assess this condition. Subsequently, oxygenation indices incorporating mean airway pressure have been developed, such as the oxygenation index (OI = (FiO2 × Pmean) / PaO2) and oxygenation saturation index (OSI = (FiO2 × Pmean) / SpO2). More recently, Asar et al. have defined 8 novel oxygenation indices using mean power (MP) and driving pressure (DP) instead of Pmean (OSI-MPtot, OI-MPtot, OSI-ΔPinsp, OI-ΔPinsp, OSI-MPdyn, OI-MPdyn, PaO2/(FiO2xPEEP), and SpO2/FiO2xPEEP). They compared the predictive power of these new indices for intensive care unit (ICU) mortality in COVID-ARDS (C-ARDS) patients with conventional oxygenation indices (PaO2/FiO2, SpO2/FiO2, OI, OSI). OI-ΔPinsp, OSI-ΔPinsp, and OSI-MPdyn indices were found to have the highest predictive power for ICU mortality. However, there is currently no study investigating the changes of these new indices during the intraoperative period. ### Conditions Module **Conditions:** - Ventilator-Induced Lung Injury **Keywords:** - trendelenburg - robot-assisted laparoscopic surgery ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 42 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Day ### Arms Interventions Module #### Arm Group 1 **Description:** The patients consist of ASA I-II or III group undergoing robotic-assisted laparoscopic surgery. **Intervention Names:** - Procedure: Tint Time - Procedure: T0 Time - Procedure: T1 **Label:** Patients undergoing robotic-assisted laparoscopic surgery ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients undergoing robotic-assisted laparoscopic surgery **Description:** Arterial blood gas was obtained immediately after intubation(Tint) in supine position. Ventilator parameters and hemodynamic parameters were recorded. **Name:** Tint Time **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Patients undergoing robotic-assisted laparoscopic surgery **Description:** Arterial blood gas was obtained immediately after pneumoperitoneum in trendelenburg position. Ventilator parameters and hemodynamic parameters were recorded. **Name:** T0 Time **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Patients undergoing robotic-assisted laparoscopic surgery **Description:** Arterial blood gas was obtained immediately after pneumoperitoneum in trendelenburg position. Ventilator parameters and hemodynamic parameters were recorded. **Name:** T1 **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum OSI-MPtot in ASA I-III patients undergoing robot-assisted laparoscopic surgery. **Measure:** Oxygenation indices **Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours) **Description:** This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on OI-MPtot in ASA I-III patients undergoing robot-assisted laparoscopic surgery. **Measure:** Oxygenation indices **Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours) **Description:** This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on OSI-ΔPinsp in ASA I-III patients undergoing robot-assisted laparoscopic surgery. **Measure:** Oxygenation indices **Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours) **Description:** This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on OI-ΔPinsp in ASA I-III patients undergoing robot-assisted laparoscopic surgery. **Measure:** Oxygenation indices **Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours) **Description:** This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on OSI-MPdyn in ASA I-III patients undergoing robot-assisted laparoscopic surgery. **Measure:** Oxygenation indices **Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours) **Description:** This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on OI-MPdyn in ASA I-III patients undergoing robot-assisted laparoscopic surgery. **Measure:** Oxygenation indices **Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours) **Description:** This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on PaO2/(FiO2xPEEP) in ASA I-III patients undergoing robot-assisted laparoscopic surgery. **Measure:** Oxygenation indices **Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours) **Description:** This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on SpO2/FiO2xPEEP in ASA I-III patients undergoing robot-assisted laparoscopic surgery. **Measure:** Oxygenation indices **Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours) **Description:** This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on SpO2/FiO2 in ASA I-III patients undergoing robot-assisted laparoscopic surgery. **Measure:** Oxygenation indices **Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours) **Description:** This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on OI (oxygenation index) in ASA I-III patients undergoing robot-assisted laparoscopic surgery. **Measure:** Oxygenation indices **Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours) **Description:** This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on OSI (oxygenation saturation index) in ASA I-III patients undergoing robot-assisted laparoscopic surgery. **Measure:** Oxygenation indices **Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours) #### Secondary Outcomes **Description:** Change in PEEP (cmH2O) with Trendelenburg position and pneumoperitoneum **Measure:** Mechanical ventilator parameters **Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours) **Description:** Change in compliance (mL/cmH2O) with Trendelenburg position and pneumoperitoneum **Measure:** Mechanical ventilator parameters **Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours) **Description:** Change in peak pressure (cmH2O) with Trendelenburg position and pneumoperitoneum **Measure:** Mechanical ventilator parameters **Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours) **Description:** Change in the pH with Trendelenburg position and pneumoperitoneum **Measure:** Arterial blood gas parameters **Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours) **Description:** Change in the base excess(mmol/lt) with Trendelenburg position and pneumoperitoneum **Measure:** Arterial blood gas parameters **Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours) **Description:** Change in the partial oxgyen(mmHg) with Trendelenburg position and pneumoperitoneum **Measure:** Arterial blood gas parameters **Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours) **Description:** Change in the partial carbon dioxide(mmHg) with Trendelenburg position and pneumoperitoneum **Measure:** Arterial blood gas parameters **Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours) **Description:** Change in the lactate(mmol/lt) with Trendelenburg position and pneumoperitoneum **Measure:** Arterial blood gas parameters **Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours) **Description:** Change in the heart rate with Trendelenburg position and pneumoperitoneum **Measure:** Hemodynamic parameters **Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours) **Description:** Change in the mean arterial blood pressure with Trendelenburg position and pneumoperitoneum **Measure:** Hemodynamic parameters **Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ASA (American Society of Anesthesiologists) class I-III * Age between 18-75 years * Signed informed consent form Exclusion Criteria: * Diagnosis of COPD (Chronic Obstructive Pulmonary Disease) and asthma * History of thoracic surgery * Body mass index (BMI) \> 35 * Development of hemodynamic instability or desaturation (SpO2 \< 92) during the operation **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Study Population The study will include 42 volunteer patients, aged over 18, classified under the American Society of Anesthesiologists Physical Status Classification (ASA) I-III risk groups, who are scheduled to undergo robot-assisted laparoscopic surgery at the Health Sciences University Basaksehir Cam and Sakura City Hospital operating room. ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Basaksehir Cam Sakura City Hospital ### IPD Sharing Statement Module **Description:** Not decided yet **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. No abstract available. Erratum In: N Engl J Med. 2014 Apr 24;370(17):1668-9. **PMID:** 24283226 **Citation:** Kalmar AF, Foubert L, Hendrickx JF, Mottrie A, Absalom A, Mortier EP, Struys MM. Influence of steep Trendelenburg position and CO(2) pneumoperitoneum on cardiovascular, cerebrovascular, and respiratory homeostasis during robotic prostatectomy. Br J Anaesth. 2010 Apr;104(4):433-9. doi: 10.1093/bja/aeq018. Epub 2010 Feb 18. **PMID:** 20167583 **Citation:** Queiroz VNF, da Costa LGV, Barbosa RP, Takaoka F, De Baerdemaeker L, Cesar DS, D'Orto UC, Galdi JR, Gottumukkala V, Cata JP, Hemmes SNT, Hollman MW, Kalmar A, Moura LAB, Mariano RM, Matot I, Mazzinari G, Mills GH, Posso IP, Teruya A, Vidal Melo MF, Sprung J, Weingarten TN, Treschan TA, Koopman S, Eidelman L, Chen LL, Lee JW, Arino Irujo JJ, Tena B, Groeben H, Pelosi P, de Abreu MG, Schultz MJ, Serpa Neto A; AVATaR and PROVE Network investigators. International multicenter observational study on assessment of ventilatory management during general anaesthesia for robotic surgery and its effects on postoperative pulmonary complication (AVATaR): study protocol and statistical analysis plan. BMJ Open. 2018 Aug 23;8(8):e021643. doi: 10.1136/bmjopen-2018-021643. **PMID:** 30139899 **Citation:** Serpa Neto A, Hemmes SN, Barbas CS, Beiderlinden M, Biehl M, Binnekade JM, Canet J, Fernandez-Bustamante A, Futier E, Gajic O, Hedenstierna G, Hollmann MW, Jaber S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Putensen C, Ranieri M, Scavonetto F, Schilling T, Schmid W, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Gama de Abreu M, Pelosi P, Schultz MJ; PROVE Network Investigators. Protective versus Conventional Ventilation for Surgery: A Systematic Review and Individual Patient Data Meta-analysis. Anesthesiology. 2015 Jul;123(1):66-78. doi: 10.1097/ALN.0000000000000706. **PMID:** 25978326 **Citation:** O'Gara B, Talmor D. Perioperative lung protective ventilation. BMJ. 2018 Sep 10;362:k3030. doi: 10.1136/bmj.k3030. **PMID:** 30201797 **Citation:** Tartler TM, Ahrens E, Munoz-Acuna R, Azizi BA, Chen G, Suleiman A, Wachtendorf LJ, Costa ELV, Talmor DS, Amato MBP, Baedorf-Kassis EN, Schaefer MS. High Mechanical Power and Driving Pressures are Associated With Postoperative Respiratory Failure Independent From Patients' Respiratory System Mechanics. Crit Care Med. 2024 Jan 1;52(1):68-79. doi: 10.1097/CCM.0000000000006038. Epub 2023 Sep 11. **PMID:** 37695139 **Citation:** Asar S, Rahim F, Rahimi P, Acicbe O, Tontu F, Cukurova Z. Novel Oxygenation and Saturation Indices for Mortality Prediction in COVID-19 ARDS Patients: The Impact of Driving Pressure and Mechanical Power. J Intensive Care Med. 2024 Jun;39(6):595-608. doi: 10.1177/08850666231223498. Epub 2024 Jan 5. **PMID:** 38179691 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000013898 - Term: Thoracic Injuries - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M28143 - Name: Lung Injury - Relevance: HIGH - As Found: Lung Injury - ID: M28152 - Name: Ventilator-Induced Lung Injury - Relevance: HIGH - As Found: Ventilator-Induced Lung Injury - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M16657 - Name: Thoracic Injuries - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000055370 - Term: Lung Injury - ID: D000055397 - Term: Ventilator-Induced Lung Injury ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430593 **Brief Title:** Evaluation of Low Flow and Normal Flow Anesthesia Management in Robotic Assisted Laparoscopic Surgeries **Official Title:** Evaluation of Low Flow and Normal Flow Anesthesia Management in Robotic Assisted Laparoscopic Surgeries #### Organization Study ID Info **ID:** 2024- 183 #### Organization **Class:** OTHER_GOV **Full Name:** Başakşehir Çam & Sakura City Hospital ### Status Module #### Completion Date **Date:** 2024-09-25 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-25 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Başakşehir Çam & Sakura City Hospital #### Responsible Party **Investigator Affiliation:** Başakşehir Çam & Sakura City Hospital **Investigator Full Name:** Hilal AKCA **Investigator Title:** Anesthesiologist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Robotic-assisted laparoscopic surgery has many advantages compared to conventional open surgery, such as less postoperative pain, shorter hospital stays, and faster recovery times. Robot-assisted surgeries require general anesthesia. In our clinic, we routinely apply low-flow anesthesia methods in addition to normal flow methods in many surgical applications, according to clinician preferences. The aim of this study is to determine the effects of low flow (0.5 lt/min) and normal flow (\>1 lt/min) anesthesia applications in robotic-assisted laparoscopic surgeries. To compare perioperative hemodynamic and respiratory parameters in terms of inhalation agent and soda lime consumption. **Detailed Description:** Robotic surgery is the performance of laparoscopic surgery using a robotic interface. The robotic surgery system used today is called Da Vinci S. In surgeries performed with the help of a robot, the surgeon can work more precisely and with greater maneuverability. Therefore, an operation can be performed that is less traumatic for the patient than other methods.Robotic-assisted laparoscopic surgery has many advantages compared to conventional open surgery, such as less postoperative pain, shorter hospital stays, and faster recovery times. Robot-assisted surgeries require general anesthesia. In these applications, fresh gas flow in anesthesia systems can be made with traditional high, normal or low flow strategies, depending on the preference of the clinicians.Low-flow anesthesia creates a breathing air closer to physiological conditions during anesthesia by heating and humidifying the inhaled gases. In addition, it provides cost advantage by reducing inhalation agent consumption and reduces atmospheric pollution. It is suggested that the use of both fresh gas flow amounts does not pose a safety risk for patients, and that the use of low-flow anesthesia methods should be more widespread due to the advantages it provides. In our clinic, investigators routinely apply low-flow anesthesia methods in addition to normal flow methods in many surgical applications, according to clinician preferences. The aim of this study is to determine the effects of low flow (0.5 lt/min) and normal flow (\>1 lt/min) anesthesia applications in robotic-assisted laparoscopic surgeries. To compare perioperative hemodynamic and respiratory parameters in terms of inhalation agent and soda lime consumption. ### Conditions Module **Conditions:** - Oncology **Keywords:** - low-flow anesthesia - robotic-assisted surgery - general anesthesia ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 68 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 6 Months ### Arms Interventions Module #### Arm Group 1 **Description:** 0,5 lt/min **Intervention Names:** - Procedure: low-flow anesthesia **Label:** low-flow anesthesia #### Arm Group 2 **Description:** \>1 lt/min **Intervention Names:** - Procedure: low-flow anesthesia **Label:** normal flow anesthesia ### Interventions #### Intervention 1 **Arm Group Labels:** - low-flow anesthesia - normal flow anesthesia **Description:** 0,5 l/min \>1 l/min **Name:** low-flow anesthesia **Other Names:** - normal flow anesthesia **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** It was aimed to compare heart rates in patients undergoing low flow (0.5 lt/min) and normal flow (\>1 lt/min) anesthesia. **Measure:** Hemodynamic Parameters **Time Frame:** Perioperative period(approximately 3-6 hours) **Description:** It was aimed to compare blood pressure in patients undergoing low flow (0.5 lt/min) and normal flow (\>1 lt/min) anesthesia. **Measure:** Hemodynamic Parameters **Time Frame:** Perioperative period(approximately 3-6 hours) **Description:** It was aimed to compare oxygen saturation in patients undergoing low flow (0.5 lt/min) and normal flow (\>1 lt/min) anesthesia. **Measure:** Respiratory parameters **Time Frame:** Perioperative period(approximately 3-6 hours) **Description:** It was aimed to compare endtidal carbon dioxide in patients undergoing low flow (0.5 lt/min) and normal flow (\>1 lt/min) anesthesia. **Measure:** Respiratory parameters **Time Frame:** Perioperative period(approximately 3-6 hours) **Description:** It was aimed to compare inhalation agent (sevoflurane) consumption (lt) in patients undergoing low flow (0.5 lt/min) and normal flow (\>1 lt/min) anesthesia. **Measure:** Inhalation agent (sevoflurane) consumption **Time Frame:** Perioperative period(approximately 3-6 hours) **Description:** It was aimed to compare soda lime consumption in patients undergoing low flow (0.5 lt/min) and normal flow (\>1 lt/min) anesthesia. Soda lime consumption refers to the number of changes of the soda lime canister. **Measure:** Soda lime consumption **Time Frame:** Perioperative period(approximately 3-6 hours) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Ages 18-75 * ASA I,II * Patients undergoing robotic-assisted laparoscopic surgery Exclusion Criteria: * ASA III,IV,V * Those with serious cardiac, respiratory, hepatic, renal disease * People with mental status disorders, psychiatric illnesses * Patients with hearing problems and glaucoma * Desire to be out of work **Healthy Volunteers:** True **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Ages 18-75, ASA I,II, Patients undergoing robotic-assisted laparoscopic surgery ## Derived Section ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### 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:** NCT06430580 **Acronym:** COBRAS **Brief Title:** Cannabinoids and Biological Reactivity to Stress **Official Title:** Cannabinoids and Biological Reactivity to Stress #### Organization Study ID Info **ID:** 20241368 #### Organization **Class:** OTHER **Full Name:** Auburn University #### Secondary ID Infos **ID:** R21DA058780-01A1 **Link:** https://reporter.nih.gov/quickSearch/R21DA058780-01A1 **Type:** NIH ### Status Module #### Completion Date **Date:** 2026-03-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-03-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Wayne State University **Class:** NIH **Name:** National Institute on Drug Abuse (NIDA) #### Lead Sponsor **Class:** OTHER **Name:** Auburn University #### Responsible Party **Investigator Affiliation:** Auburn University **Investigator Full Name:** Richard Macatee **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this study is to test the impact of two drugs that produce temporary stress-like symptoms, both in isolation and together, on cannabis use motivation in individuals with Cannabis Use Disorder. The main questions it will answer are: 1. How do different forms of stress affect cannabis use motivation? 2. How do different forms of stress affect the body's natural cannabinoids? Researchers will compare a placebo to both drugs in isolation, as well as together, across four separate lab visits. Participants will: 1) Complete a clinical screening interview (by phone or in-person) and visit the lab for a medical screening, and if eligible: a) Visit the lab four times where they will: i). Take one of four drug combinations ii). Complete an interview, questionnaires, and computerized tasks iii). Have their brain activity recorded with an EEG cap iv). Provide three blood samples **Detailed Description:** The prevalence of daily cannabis use and cannabis use disorder (CUD) has increased in the United States over the past two decades. Unfortunately, psychosocial treatments produce minimal long-term abstinence rates and no FDA-approved medications for CUD exist. Thus, identifying novel CUD treatment targets is an increasingly urgent public health need. Stress-elicited cannabis use motivation has been implicated in worse CUD outcomes, but a mechanistic understanding of how acute stress increases cannabis use motivation in CUD is limited. Prior work has demonstrated that acute psychosocial stress enhancement of subsequent cannabis cue incentive salience, as indexed by the late positive potential (neural measure of approach-motivated attention recorded using electroencephalography \[EEG\]), was associated with worse CUD severity and intervention response, independent of subjective craving. Moreover, hypothalamic pituitary adrenal \[HPA\]-axis, rather than noradrenergic or subjective reactivity to the psychosocial stressor was associated with subsequent potentiation of the cannabis cue-elicited late positive potential. These studies suggest that non-genomic, rapid glucocorticoid effects may be a contributing mechanism in stress amplification of neural drug-cue reactivity, but their correlational designs preclude causal inference. Further, psychosocial stressors are unable to isolate HPA-axis vs. noradrenergic components of stress reactivity. To isolate HPA-axis activation and test causality, pharmacological manipulations, common in animal models but rare in human studies, will be used to produce separate and co-operative glucocorticoid (20mg hydrocortisone) and noradrenergic (54mg yohimbine) activation. The investigators will employ a 2x2 randomized, placebo-controlled double-blind crossover design in 36 participants with severe CUD. The primary aim is to test the causal potentiating effect of glucocorticoids on drug-cue reactivity and drug use motivation, and further determine if the effect depends on co-occurring noradrenergic stimulation. Preclinical work indicates that glucocorticoids can potentiate reward motivation via mobilization of endocannabinoid activity (primary target of cannabis). Thus, as an exploratory aim, the investigators will obtain plasma samples to test the impact of pharmacological stress on circulating endocannabinoids (2-AG, AEA) and their mediating role in glucocorticoid potentiation of drug-cue reactivity and drug use motivation. This project represents a highly novel integration of a rigorous pharmacological challenge design with biological markers of drug-cue incentive salience and endocannabinoid system activity. If hypotheses are confirmed, one causal mechanism through which stress increases neural cannabis cue reactivity will be known, which has immediate implications for testing experimental therapeutics. The long-term goal is to understand how a stress-related mechanism predictive of worse CUD phenotype is generated and can be blocked in CUD. Development of this model will provide a valid, efficient and (relative to other neuroimaging methods) low-cost approach to screen candidate medications and optimize psychosocial drug cue exposure therapies. ### Conditions Module **Conditions:** - Cannabis Use Disorder ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** 2x2 randomized double-blind within-subject crossover ##### Masking Info **Masking:** TRIPLE **Masking Description:** Double-blind **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 20mg hydrocortisone, single oral dose 54mg yohimbine hcl, single oral dose **Intervention Names:** - Drug: Hydrocortisone Oral - Drug: Yohimbine Hydrochloride **Label:** 20mg hydrocortisone + 54mg yohimbine hcl **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 20mg hydrocortisone, single oral dose 54mg cornstarch placebo, single oral dose **Intervention Names:** - Drug: Hydrocortisone Oral - Drug: Cornstarch Placebo 54mg **Label:** 20mg hydrocortisone + 54mg placebo **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** 20mg cornstarch placebo, single oral dose 54mg yohimbine hcl, single oral dose **Intervention Names:** - Drug: Yohimbine Hydrochloride - Drug: Cornstarch Placebo 20mg **Label:** 20mg placebo + 54mg yohimbine hcl **Type:** ACTIVE_COMPARATOR #### Arm Group 4 **Description:** 20mg cornstarch placebo, single oral dose 54mg cornstarch placebo, single oral dose **Intervention Names:** - Drug: Cornstarch Placebo 20mg - Drug: Cornstarch Placebo 54mg **Label:** 20mg placebo + 54mg placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - 20mg hydrocortisone + 54mg placebo - 20mg hydrocortisone + 54mg yohimbine hcl **Description:** 20mg hydrocortisone, single oral dose **Name:** Hydrocortisone Oral **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - 20mg hydrocortisone + 54mg yohimbine hcl - 20mg placebo + 54mg yohimbine hcl **Description:** 54mg yohimbine hcl, single oral dose **Name:** Yohimbine Hydrochloride **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - 20mg placebo + 54mg placebo - 20mg placebo + 54mg yohimbine hcl **Description:** 20mg cornstarch placebo, single oral dose **Name:** Cornstarch Placebo 20mg **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - 20mg hydrocortisone + 54mg placebo - 20mg placebo + 54mg placebo **Description:** 54mg cornstarch placebo, single oral dose **Name:** Cornstarch Placebo 54mg **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Change in electroencephalography-recorded (EEG) late positive potential amplitude to cannabis cue images after hydrocortisone (with or without yohimbine) compared to placebo+placebo and yohimbine+placebo conditions (higher amplitudes indicate worse outcome) **Measure:** Amplitude of neurophysiological response to cannabis cues (μV) **Time Frame:** Late positive potential amplitude outcome is assessed at each of the four lab visits, which take place over the study period (10-22 days) **Description:** Marijuana purchase task-derived Intensity after hydrocortisone administration (with or without yohimbine) compared to placebo+placebo and yohimbine+placebo (increased Intensity indicates worse outcome) **Measure:** Amplitude of Demand Intensity for Cannabis (# of hits at $0) **Time Frame:** Intensity is assessed at each of the four lab visits, which take place over the study period (10-22 days) **Description:** Marijuana purchase task-derived OMax after hydrocortisone administration (with or without yohimbine) compared to placebo+placebo and yohimbine+placebo (increased OMax indicates worse outcome) **Measure:** Peak Total Monetary Expenditure for Cannabis (total amount of money spent on hits) **Time Frame:** OMax is assessed at each of the four lab visits, which take place over the study period (10-22 days) **Description:** Marijuana purchase task-derived Breakpoint after hydrocortisone administration (with or without yohimbine) compared to placebo+placebo and yohimbine+placebo (increased Breakpoint indicates worse outcome) **Measure:** Breakpoint of Monetary Expenditure for Cannabis (price at which no hits are purchased) **Time Frame:** Breakpoint is assessed at each of the four lab visits, which take place over the study period (10-22 days) **Description:** Marijuana purchase task-derived Elasticity after hydrocortisone administration (with or without yohimbine) compared to placebo+placebo and yohimbine+placebo (decreased Elasticity indicates worse outcome) **Measure:** Sensitivity of Cannabis Hit Purchasing Behavior to Price Increases **Time Frame:** Elasticity is assessed at each of the four lab visits, which take place over the study period (10-22 days) **Description:** Change in cannabis image selections on the Implicit Image Choice Task (computerized behavioral task; range 0-30; higher scores indicate worse outcome) after hydrocortisone administration (with and without yohimbine) compared to placebo+placebo and yohimbine+placebo **Measure:** Frequency of implicit cannabis image choice **Time Frame:** Implicit choice task # of cannabis image selections outcome is assessed at each of the four lab visits, which take place over the study period (10-22 days) **Description:** Change in cannabis image selections on the Explicit Image Choice Task (computerized behavioral task; range 0-30; higher scores indicate worse outcome) after hydrocortisone administration (with and without yohimbine) compared to placebo+placebo and yohimbine+placebo **Measure:** Frequency of explicit cannabis image choice **Time Frame:** Explicit choice task # of cannabis image selections outcome is assessed at each of the four lab visits, which take place over the study period (10-22 days) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Meets criteria for current, severe Cannabis Use Disorder (CUD) as assessed by the Structured Clinical Interview (SCID) for the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) during the screening interview. * Reports engagement in daily cannabis use. * Provide a urine sample positive for THC. * Must be adequately informed of the nature and risks of the study and given written informed consent prior to screening. * Able to read and write in English. Exclusion Criteria: * Has a history of serious psychiatric problems (i.e., psychosis, Bipolar Disorder I), as assessed by the SCID-V-RV. * Reports current active suicidal ideation. * Meets DSM-5 criteria for any other current substance use disorder (other than CUD or Tobacco Use Disorder) * Has a positive result urine drug screen for all other drugs aside from THC (i.e., amphetamine, methamphetamine, benzodiazepine, cocaine, MDMA, morphine, oxycodone, methadone, buprenorphine) at screening or at any lab visit. * Has structural brain abnormalities (e.g., neoplasms), stroke, seizures, infectious disease, a history of other neurological diseases, or a history of head trauma resulting in unconsciousness. * Has a history of cardiovascular disease, myocardial infarction, chest pain, or palpitations on exertion or drug use, edema, hypertension, resting heart rate \<50 BPM or \>90 BPM. Cardiovascular diseases include: . a. Benign prostatic hyperplasia (BPH) b. Post-myocardial infarction * Demonstrates systolic BP outside of acceptable range (80-160mmHG), or diastolic BP outside of acceptable range (50-90 mmHG) * Has a history of obstructive pulmonary disease, cor pulmonale, dyspnea, orthopnea, tachypnea (\>24 breaths per minute), or asthma. * Currently taking any daily psychotropic medication * Currently taking any of the following medications: 1. Angiotensin-Converting Enzyme (ACE) inhibitors including Lisinopril, Enalapril, Benazepril, and Bamipril 2. Angiotensin II Receptor Blockers (ARB) including Losartan, Valsartan, and Olmesartan 3. Thiazide Diuretics including Hydrochlorothiazide (HCTZ), Chlorthalidone 4. Calcium Channel Blockers including Amlodipine, Diltiazem, and Verapamil 5. Beta-blockers including Carvedilol, Metoprolol, Atenolol, Propranolol 6. Anti-Arrythmic Medication including Disopyramide, Flecainide, and Mexiletine 7. Edema (Diuretics) 8. Thiazide Diuretics (as above) 9. Loop Diuretics including Furosemide and Torsemide 10. Potassium Sparing Diuretics: Spironolactone and Eplerenone 11. Anti-Platelet Medications such as Clopidogrel, Prasugrel, and Ticagrelor * Reproductively capable candidates who are pregnant (based on urine test at screening or at any lab visit) or are heterosexually active and not using medically approved birth control measures (oral contraceptives, IUD, condom, sterilization). * Self-reports currently seeking or engaging in CUD treatment or any other alcohol or drug treatment. * Self-reports intent to imminently quit cannabis use. * Has a Blood-Injection-Injury Phobia, as determined by scores greater than 15 on the Injection and Blood Draw subscale of the Medical Fear Survey **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Julia Gorday, MS **Phone:** (334)-844-6642 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Auburn University **Name:** Richard J Macatee, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC25 - Name: Substance Related Disorders - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5449 - Name: Marijuana Abuse - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000009184 - Term: Mydriatics - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000058669 - Term: Adrenergic alpha-2 Receptor Antagonists - ID: D000000317 - Term: Adrenergic alpha-Antagonists - ID: D000018674 - Term: Adrenergic Antagonists - ID: D000018663 - Term: Adrenergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000064804 - Term: Urological Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Urol - Name: Urological Agents - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: M9912 - Name: Hydrocortisone - Relevance: HIGH - As Found: Aortic - ID: M155245 - Name: Hydrocortisone 17-butyrate 21-propionate - Relevance: LOW - As Found: Unknown - ID: M228609 - Name: Hydrocortisone acetate - Relevance: LOW - As Found: Unknown - ID: M263259 - Name: Hydrocortisone hemisuccinate - Relevance: LOW - As Found: Unknown - ID: M17752 - Name: Yohimbine - Relevance: HIGH - As Found: AVP-923 - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M12139 - Name: Mydriatics - Relevance: LOW - As Found: Unknown - ID: M20746 - Name: Adrenergic Agents - Relevance: LOW - As Found: Unknown - ID: M29195 - Name: Adrenergic alpha-2 Receptor Antagonists - Relevance: LOW - As Found: Unknown - ID: M3669 - Name: Adrenergic alpha-Antagonists - Relevance: LOW - As Found: Unknown - ID: M20755 - Name: Adrenergic Antagonists - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: T332 - Name: Yohimbe - Relevance: HIGH - As Found: AVP-923 ### Intervention Browse Module - Meshes - ID: D000006854 - Term: Hydrocortisone - ID: D000015016 - Term: Yohimbine ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430567 **Acronym:** BFR **Brief Title:** Blood Flow Restriction in Post-surgery Rehabilitation of Latarjet Procedure **Official Title:** Comparing the Effectiveness of Blood Flow Restriction Training and Traditional Resistance Training in Post-surgery Rehabilitation of Latarjet Procedure #### Organization Study ID Info **ID:** EHC Morges BFR #### Organization **Class:** OTHER **Full Name:** Ensemble Hospitalier de la Côte ### Status Module #### Completion Date **Date:** 2027-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-10 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **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:** Ensemble Hospitalier de la Côte #### Responsible Party **Investigator Affiliation:** Ensemble Hospitalier de la Côte **Investigator Full Name:** Arnaud Meylan **Investigator Title:** Doctor **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:** The goal of this clinical trial is to evaluate the effects of Blood Flow Restriction (BFR) training on post-surgery rehabilitation following the Latarjet procedure in athletes aged 18-35. The main questions it aims to answer are: Does BFR training improve scapular belt muscle strength post-surgery? Does BFR training enhance shoulder function during rehabilitation? Researchers will compare three groups: BFR Group with 50% AOP \[arterial occlusion pressure\] compression BFR Placebo Group with 10% AOP compression Control Group Participants will: Perform the same four strengthening exercises twice a week Complete 16 semi-autonomous strength training sessions over 8 weeks Undergo isokinetic and isometric strength tests, shoulder mobility assessments, and complete self-assessment questionnaires. ### Conditions Module **Conditions:** - Shoulder Dislocation **Keywords:** - Blood flow restriction - Latarjet surgery - Rehabilitation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Masking Description:** Participants between placebo and intervention group will be blinded **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patient will not use BFR **Label:** Control **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Patient will use BFR sub optimally as described in the literature **Intervention Names:** - Device: Blood flow restriction (10% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability **Label:** Placebo 10% of pressure for arterial occlusion **Type:** PLACEBO_COMPARATOR #### Arm Group 3 **Description:** Patient will use the minimal pressure of 50% of arterial occlusion known to be effective in the literature **Intervention Names:** - Device: Blood flow restriction (50% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability **Label:** Interventional 50% of pressure for arterial occlusion **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Interventional 50% of pressure for arterial occlusion **Description:** Participants undergoing shoulder instability surgery (Latarjet procedure) by a single surgeon will receive standard physiotherapy (2 sessions per week) before being randomized into 3 groups at their 6th postoperative week check-up: Group 1) BFR Group with 50% AOP compression Group 1 will perform a 30-minute strengthening session twice weekly during postoperative weeks 7 to 14. They will do 4 exercises, completing 4 sets with 30-second rest intervals and 1 minute between exercises, following 30-15-15-15 at 40% 1RM (repetition maximum) Exercise : External rotation with pulley/band Internal rotation with pulley/band Frontal elevation with hyperpronation Diagonal abduction-external rotation with pulley/band BFR training will use the MadUp© system, placing the band proximally on the operated arm, with a central unit continuously monitoring and calibrating arm pressure. **Name:** Blood flow restriction (50% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Placebo 10% of pressure for arterial occlusion **Description:** Participants undergoing shoulder instability surgery (Latarjet procedure) by a single surgeon will receive standard physiotherapy (2 sessions per week) before being randomized into 3 groups at their 6th postoperative week check-up: Group 2) BFR Group with 10% AOP compression Group 2 will perform a 30-minute strengthening session twice weekly during postoperative weeks 7 to 14. They will do 4 exercises, completing 4 sets with 30-second rest intervals and 1 minute between exercises, following 15-15-15-15 at 70% 1RM Exercise : External rotation with pulley/band Internal rotation with pulley/band Frontal elevation with hyperpronation Diagonal abduction-external rotation with pulley/band BFR training will use the MadUp© system, placing the band proximally on the operated arm, with a central unit continuously monitoring and calibrating arm pressure. **Name:** Blood flow restriction (10% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Concentric peak torque (Nm) IR-ER at 60°/sec **Measure:** Isokinetic strength **Time Frame:** Preoperative and at 14 weeks postoperative **Description:** Concentric peak torque (Nm) IR-ER at 240°/sec **Measure:** Isokinetic strength **Time Frame:** Preoperative and at 14 weeks postoperative **Description:** Eccentric peak torque (Nm) IR-ER at 60°/sec **Measure:** Isokinetic strength **Time Frame:** Preoperative and at 14 weeks postoperative **Description:** Concentric ratio (ER conc 60°/ IR conc 60°) **Measure:** Isokinetic strength **Time Frame:** Preoperative and at 14 weeks postoperative **Description:** Cocking gesture ratio (IR exc 60° /ER conc 240°) **Measure:** Isokinetic strength **Time Frame:** Preoperative and at 14 weeks postoperative **Description:** Flexion in the scapular plane (Nm) **Measure:** Isometric strength **Time Frame:** Preoperative and at 14 weeks postoperative **Description:** Athletic shoulder test (positions I, Y, T) (Nm) **Measure:** Isometric strength **Time Frame:** Preoperative and at 14 weeks postoperative **Description:** Grip test (Nm) **Measure:** Isometric strength **Time Frame:** Preoperative and at 14 weeks postoperative #### Secondary Outcomes **Description:** Flexion **Measure:** Shoulder mobility **Time Frame:** Preoperative and at 14 weeks postoperative **Description:** Abduction **Measure:** Shoulder mobility **Time Frame:** Preoperative and at 14 weeks postoperative **Description:** Internal rotation at 90° abduction **Measure:** Shoulder mobility **Time Frame:** Preoperative and at 14 weeks postoperative **Description:** External rotation at 90° abduction **Measure:** Shoulder mobility **Time Frame:** Preoperative and at 14 weeks postoperative **Description:** Scapular dyskinesis test (SDT) **Measure:** Shoulder mobility **Time Frame:** Preoperative and at 14 weeks postoperative **Description:** Modified closed kinetic upper extremity stability test **Measure:** Scapular girdle stability **Time Frame:** Preoperative and at 14 weeks postoperative **Description:** Shoulder Instability Return to Sport Index (SIRSI) **Measure:** Scapular girdle stability **Time Frame:** Preoperative and at 14 weeks postoperative **Description:** Western Ontario Shoulder Instability Index (WOSI) **Measure:** Scapular girdle stability **Time Frame:** Preoperative and at 14 weeks postoperative ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age: 18-35 years * Indication for shoulder stabilization surgery using the Latarjet procedure (documented anterior dislocations with proof of emergency reduction, with or without hypermobility and confirmation of traumatic capsulo-ligamentous injury by MRI). * Regular exercise (min. 1x / week) * Signed the informed consent form for the study. Exclusion Criteria: * Pregnant or breast-feeding women * Active oncological disease under treatment. (Patient with stable oncological disease eligible) * Adverse events during the 6-week post-operative period such as:-Fracture/displacement of the reconstructed bone-Luxation of the operated shoulder-Requirement for emergency hospitalization * History of deep vein thrombosis/pulmonary embolism * Inability to follow study procedures, due to language problems, psychological disorders, dementia. * Need for skin grafting following shoulder stabilization surgery * Coronary heart disease * Unstable hypertension * Peripheral vascular disease * Hypercoagulable states (blood coagulation disorders) * Left ventricular dysfunction * Hemophilia **Maximum Age:** 35 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Bauer Stefan, MD **Phone:** 0787105993 **Phone Ext:** +41 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Arnaud Meylan, MD **Phone:** 0792092956 **Phone Ext:** +41 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** EHC Morges **Name:** Bauer Stefan, MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004204 - Term: Joint Dislocations - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000014947 - Term: Wounds and Injuries - ID: D000070599 - Term: Shoulder Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M15591 - Name: Shoulder Dislocation - Relevance: HIGH - As Found: Shoulder Dislocation - ID: M7385 - Name: Joint Dislocations - 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: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M602 - Name: Shoulder Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012783 - Term: Shoulder Dislocation ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430554 **Brief Title:** Personalized Ventilation Based on Ventilation-perfusion Mismatch and Lung Recruitability **Official Title:** Personalized Ventilatory Strategy Based on Ventilation-perfusion Mismatch and Lung Recruitability in Moderate-to-severe ARDS Patients #### Organization Study ID Info **ID:** 2024ZDSYLL044-P01 #### Organization **Class:** OTHER **Full Name:** Zhongda Hospital ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Zhongda Hospital #### Responsible Party **Investigator Affiliation:** Zhongda Hospital **Investigator Full Name:** Fengmei Guo **Investigator Title:** Director of Intensive Care Unit, Principal Investigator, Clinical Professor, Zhongda Hospital, Southeast University, China **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This observational study will explore the effects of PEEP and position on regional lung ventilation-perfusion mismatch by electrical impedance tomography (EIT) in moderate-to-severe ARDS patients with different lung recruitability. **Detailed Description:** Acute respiratory distress syndrome (ARDS) is characterized by impaired ventilation-perfusion matching, which not only indicates the severity of the condition but also contributes to ventilation-induced lung injury. Higher positive end-expiratory pressure (PEEP) and prone position could improve ventilation-perfusion mismatch by recruiting collapsed lungs and facilitating more homogeneous ventilation, but these benefits might depend on lung recruitability. The present study aims to elucidate the regional effect of PEEP(low and high) and body position(supine and prone) on the ventilation-perfusion matching. Also endeavors to establish correlations between alterations in ventilation-perfusion matching patterns and the inherent lung recruitability. Participants will be deeply sedated and paralyzed, ventilated in volume-controlled with protective ventilation (tidal volume=6-8 mL/Kg of predicted body weight and respiratory rate set to obtain normal pH). Then the patients will be sequentially assigned to each of four conditions as follows: Low PEEP, supine position; High PEEP, supine position; Low PEEP, prone position; High PEEP, prone position. High PEEP and low PEEP is defined as 15 cmH2O and 5 cmH2O (or airway opening pressure, either of which was higher) respectively. Each measurement (e.g., arterial blood gas analysis, respiratory parameters, hemodynamics, EIT measurements) will be performed at least 15 minutes after changing ventilator settings and at least 1 hour after changing body positions. The timing of turning patients from supine to prone position is determined by the clinical team. To assess lung recruitability, a single-breath derecruitment maneuver will be performed by changing PEEP 15 to 5 cmH2O (or airway opening pressure, either of which was higher) in supine position. Patients with recruitment-inflation ratio over the median value are defined as high recruiters. EIT data will be collected by standard device (Infinity C500, Drager, Germany) with a sample rate of 50 Hz. The EIT belt will be placed directly below the armpits, between the third and fifth intercostal spaces. This positioning of the EIT belt will be maintained consistently during both supine and prone positions. A bolus of 10 ml 5% NaCl will be injected during a respiratory pause (≥8 s) through the central venous catheter to assess lung ventilation and perfusion distributions. The primary endpoint is EIT-based ventilation-perfusion matching (V/Q match%). ### Conditions Module **Conditions:** - Respiratory Distress Syndrome - Positive-Pressure Respiration - Mechanical Ventilation **Keywords:** - Acute respiratory distress syndrome;Positive end expiratory pressure; Prone Position; Ventilation/perfusion matching. ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** corresponding to the pixels that are both ventilated and perfused divided by the total number of pixels ventilated and/or perfused **Measure:** Ventilation-perfusion matching (V/Q match%) **Time Frame:** Through study completion (within 24 hours) #### Secondary Outcomes **Description:** corresponding to the ventilated but nonperfused pixels divided by the total number of pixels ventilated and/or perfused **Measure:** percentage of dead space **Time Frame:** Through study completion (within 24 hours) **Description:** corresponding to the perfused but nonventilated pixels divided by the total number of pixels ventilated and/or perfused **Measure:** percentage of shunt **Time Frame:** Through study completion (within 24 hours) **Description:** The compliance of respiratory system **Measure:** Respiratory system compliance **Time Frame:** Through study completion (within 24 hours) **Description:** PaO2/FiO2 ratio **Measure:** PaO2/FiO2 ratio **Time Frame:** Through study completion (within 24 hours) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. age ≥18 years 2. Moderate-to-severe ARDS as per the 2023 ESICM definition 3. Undergoing invasive mechanical ventilation 4. Planned prone position based on the attending physicians' decisions 5. Signed informed consent Exclusion Criteria: 1. age ≥85 years 2. Pregnancy 3. Severe hemodynamic instability (\> 30% increase in vasopressors in the last 6 hours or norepinephrine \> 0.5 µg/kg/min) 4. Clinically suspected elevated intracranial pressure (\>18 mm Hg) 5. Bronchopleural fistula 6. Contraindication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode belt placement) 7. Severe hypernatremia (\>170mmol/L) 8. Re-admission of patients already enrolled in this study, or patients who are participating in other studies **Maximum Age:** 85 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Intubated mechanically ventilated ARDS patients. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Fengmei Guo, PhD, MD **Phone:** +8613813841261 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Zhiqian Zha, MM **Phone:** +8615505083904 **Role:** CONTACT #### Locations **Location 1:** **City:** Nanjing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Fengmei Guo, Ph.D - **Phone:** +8613813841261 - **Role:** CONTACT **Country:** China **Facility:** Zhongda Hospital, Southeast University **State:** Jiangsu **Status:** RECRUITING **Zip:** 210009 #### Overall Officials **Official 1:** **Affiliation:** Nanjing Zhongda Hospital, Southeast University **Name:** Fengmei Guo, PhD, MD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000012120 - Term: Respiration Disorders - ID: D000007235 - Term: Infant, Premature, Diseases - ID: D000007232 - Term: Infant, Newborn, Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14965 - Name: Respiratory Distress Syndrome - Relevance: HIGH - As Found: Respiratory Distress Syndrome - ID: M14964 - Name: Respiratory Distress Syndrome, Newborn - Relevance: HIGH - As Found: Respiratory Distress Syndrome - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M28144 - Name: Acute 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: M14957 - Name: Respiration Disorders - 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: M10276 - Name: Infant, Newborn, Diseases - Relevance: LOW - As Found: Unknown - ID: T4927 - Name: Respiratory Distress Syndrome, Infant - Relevance: HIGH - As Found: Respiratory Distress Syndrome - ID: T192 - Name: Acute Respiratory Distress Syndrome - Relevance: HIGH - As Found: Respiratory Distress Syndrome - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012128 - Term: Respiratory Distress Syndrome - ID: D000012127 - Term: Respiratory Distress Syndrome, Newborn ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430541 **Brief Title:** A Phase 1b Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence **Official Title:** A Phase 1b Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence in Patients Diagnosed With Early-stage Breast Cancer and Ovarian Cancer in Remission #### Organization Study ID Info **ID:** 23-1455.cc #### Organization **Class:** OTHER **Full Name:** University of Colorado, Denver ### Status Module #### Completion Date **Date:** 2028-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-12 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Usona Institute #### Lead Sponsor **Class:** OTHER **Name:** University of Colorado, Denver #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this clinical trial is to test whether psilocybin along with therapy in women with early breast cancer and ovarian cancer in remission can improve their fear of recurrence. The main question\[s\] it aims to answer \[is/are\]: Does psilocybin assisted therapy improve fear of cancer recurrence? Does psilocybin assisted therapy improve anxiety, depression, and quality of life? Participants will complete a series of survey measures, participate in preparatory therapy. After prep therapy is complete, they will receive a moderately high dose of psilocybin in a monitored and supportive environment. After the dosing day, they will complete 4 sessions of integrative therapy and complete survey measures. ### Conditions Module **Conditions:** - Breast Cancer - Ovarian Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 25mg cGMP Psilocybin in combination with manualized therapy **Intervention Names:** - Drug: Psilocybin **Label:** Psilocybin Assisted Psychotherapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Psilocybin Assisted Psychotherapy **Description:** A tryptamine that produces its behavioral effects primarily by acting as post-synaptic agonists at serotonin 5-HT2A and 5-HT2c receptors. **Name:** Psilocybin **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Symptoms of depression as measured by HADS-D **Measure:** Depression **Time Frame:** Baseline, 1-week, 4-weeks, 8-weeks, 12-weeks, and 24-weeks **Description:** Symptoms of anxiety as measured by HADS-A **Measure:** Anxiety **Time Frame:** Baseline, 1-week, 4-weeks, 8-weeks, 12-weeks, and 24-weeks **Description:** Demoralization Syndrome will be measured with the Demoralization Scale Version II (DS-II) **Measure:** Cancer-related Existential Distress **Time Frame:** Baseline, 1-week, 4-weeks, 8-weeks, 12-weeks, and 24-weeks **Description:** Quality of life as measured by FACT-G **Measure:** Quality of Life-FACT-G **Time Frame:** Baseline, 1-week, 4-weeks, 8-weeks, 12-weeks, and 24-weeks **Description:** Spirituality as measured by FACT-Sp **Measure:** Spirituality **Time Frame:** Baseline, 1-week, 4-weeks, 8-weeks, 12-weeks, and 24-weeks #### Primary Outcomes **Description:** Measured by change in core on the Fear of Recurrence Inventory completed at screening and baseline. **Measure:** Change in Fear of Cancer Recurrence Inventory **Time Frame:** 1-week, 4-weeks, 8-weeks* (primary outcome time point), 12-weeks, and 24-weeks. #### Secondary Outcomes **Description:** Assess Adverse Events, Treatment Emergent Adverse Events, Serious Adverse Events **Measure:** Safety as measured by adverse events **Time Frame:** for the duration of study participation -6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1, Aged ≥ 21 2. Diagnosis of: * early-stage breast cancer at low risk of recurrence * defined as clinical stage 1 or 2 * completed primary treatment (surgery, chemotherapy \[adjuvant, patients may continue to be treated with neoadjuvant\], and/or radiation) \> 6 months ago * oncologist reported risk of recurrence at 10 years \< 20% * late-stage ovarian cancer at high risk of recurrence * defined as Clinical stage 3 or 4 * currently in remission * oncologist reported risk of recurrence at 10 years \> 80% 2. Functional Status defined as: * Eastern Cooperative Oncology Group (ECOG) ≤1 * Palliative Performance Scale (PPS) ≥60% * Ability to tolerate PO medication administration 4. Fear of recurrence at screening and baseline 5. Have an identified support person * Agree to be accompanied home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing 6. Participants of childbearing potential must agree to practice an effective means of birth control throughout the duration of the study. Exclusion Criteria: 1. Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or EKG that in the opinion of the study physician would preclude safe participation in the trial. Some examples include: * Congestive heart failure * Valvular heart disease * Clinically significant arrhythmias (e.g., ventricular fibrillation, torsades) or clinically significant EKG abnormality (i.e., QTC interval \> 450) * Recent acute myocardial infarction or evidence of ischemia * Malignant hypertension * Congenital long QT syndrome * Acute renal failure * Severe hepatic impairment * Respiratory failure * eGFR \< 50 mL/min/1.73m2 * LFTs \> 1.5 x ULN * WBC \< 5 x 10\*9/L * Hemoglobin \< 8.0 g/dL * Platelets \< 150 x 10\*9/L 2. Risk for hypertensive crisis defined as: Screening, Baseline, Medication session (predose) blood pressure \>140/90 mmHg 3. Significant central nervous system (CNS) pathology Examples include: * Primary or secondary cerebral neoplasm * Epilepsy * History of stroke * Cerebral aneurysm * Dementia * Delirium 4. Primary psychotic or affective psychotic disorders Examples include current or past DSM-5 criteria for: * Schizophrenia spectrum disorders * Schizoaffective disorder * Bipolar I or bipolar II disorder * Major Depressive Disorder with psychotic features * Prior history of psychosis due to medical condition or substance use 5. Family history of psychotic or serious bipolar spectrum illnesses. Examples include first-degree relative with: * Schizophrenia spectrum disorders * Schizoaffective disorder * Bipolar I disorder with psychotic features 6. High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation and judgement. Examples include: * Agitation * Violent behavior 7. Active substance use disorders (SUDs) defined as: * DSM-5 criteria for moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine) within the past year * DAST-10 score of 3 or higher * Two or more "yes" responses to CAGE screening questionnaire 8. Extensive use of serotonergic hallucinogens (e.g., LSD, psilocybin) defined as: * Any use in the last 12 months * \>25 lifetime uses 9. Clinically significant suicidality or high risk of completed suicide defined as: * 'Yes' to C-SSRS Suicidal Ideation items 4 or 5 within the last 2 months at Screening or 'since last visit' at Baseline * Any C-SSRS Suicidal Behavior item within the past 12 months at Screening or 'since last visit' at Baseline, as defined by 'Yes' to any of the following on the C-SSRS: actual attempt, interrupted attempt, aborted attempt, or preparatory acts * Have any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self-injurious behavior 10. History of hallucinogen persisting perception disorder (HPPD) 11. Pregnancy/lactation 12. Cognitive impairment as defined by: • Montreal Cognitive Assessment Test (MoCA) \< 23 13. Concurrent Medications * Antidepressants * Centrally-acting serotonergic agents (e.g., MAO inhibitors) * Serotonin-acting dietary supplements (such as 5-hydroxy-tryptophan or St. John's wort) * Antipsychotics (e.g., first and second generation) * Mood stabilizers (e.g., lithium, valproic acid) * Aldehyde dehydrogenase inhibitors (e.g., disulfiram) * Significant inhibitors of UGT 1A0 or UGT 1A10 * Efavirenz 14. Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Cannabis, Methamphetamine, MDMA, Methadone, Opiates (Morphine, Oxycodone), and Phencyclidine (PCP). 15. Have a psychiatric condition judged to be incompatible with establishment of rapport with the study therapists or safe exposure to psilocybin 16. Have any psychological or physical symptom, medication, or other relevant finding , based on the clinical judgment of the PI or relevant clinical study staff that would make a participant unsuitable for the study. 17. Have an allergy or intolerance to any of the materials contained in the drug product 18. Non-English speaking individual 19. Be enrolled in another clinical trial assessing intervention(s) for anxiety, depression, and/or existential distress (e.g., pharmacologic or psychotherapeutic interventions) **Gender Based:** True **Minimum Age:** 21 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Mary Mancuso **Phone:** 303-724-5729 **Role:** CONTACT #### Locations **Location 1:** **City:** Aurora **Contacts:** ***Contact 1:*** - **Name:** Stacy Fischer, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Outpatient CTRC **State:** Colorado **Zip:** 80045 **Location 2:** **City:** Aurora **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Stacy Fischer, MD - **Phone:** 303-724-6353 - **Role:** CONTACT ***Contact 2:*** - **Name:** Stacy Fischer, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of Colorado Cancer Center **State:** Colorado **Zip:** 80045 #### Overall Officials **Official 1:** **Affiliation:** University of Colorado, Denver **Name:** Stacy Fischer, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases - ID: D000004701 - Term: Endocrine Gland 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: D000005833 - Term: Genital Neoplasms, Female - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000091662 - Term: Genital Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000006058 - Term: Gonadal Disorders - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14850 - Name: Recurrence - Relevance: HIGH - As Found: Recurrence - ID: M12974 - Name: Ovarian Neoplasms - Relevance: HIGH - As Found: Ovarian Cancer - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M1704 - Name: Carcinoma, Ovarian Epithelial - Relevance: HIGH - As Found: Ovarian Cancer - ID: M5534 - Name: Carcinoma - 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: M7863 - Name: Endocrine Gland Neoplasms - 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: M8945 - Name: Genital Neoplasms, Female - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M9163 - Name: Gonadal Disorders - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T4352 - Name: Ovarian Cancer - Relevance: HIGH - As Found: Ovarian Cancer - ID: T4354 - Name: Ovarian Epithelial Cancer - Relevance: HIGH - As Found: Ovarian Cancer ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms - ID: D000010051 - Term: Ovarian Neoplasms - ID: D000077216 - Term: Carcinoma, Ovarian Epithelial - ID: D000012008 - Term: Recurrence ### Intervention Browse Module - Ancestors - ID: D000006213 - Term: Hallucinogens - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000011619 - Term: Psychotropic Drugs ### Intervention Browse Module - Browse Branches - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M14419 - Name: Psilocybin - Relevance: HIGH - As Found: Frozen - ID: M15512 - Name: Serotonin - Relevance: LOW - As Found: Unknown - ID: M9305 - Name: Hallucinogens - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000011562 - Term: Psilocybin ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430528 **Brief Title:** A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement **Official Title:** A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement #### Organization Study ID Info **ID:** HUM00246263 #### Organization **Class:** OTHER **Full Name:** University of Michigan ### Status Module #### Completion Date **Date:** 2027-08 **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:** 2027-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-04-24 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Recordati Rare Diseases #### Lead Sponsor **Class:** OTHER **Name:** University of Michigan #### Responsible Party **Investigator Affiliation:** University of Michigan **Investigator Full Name:** Richard J. Auchus, MD PhD **Investigator Title:** Professor of Translational Medicine, Professor of Internal Medicine and Professor of Pharmacology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The major goal of this study is to determine the incidence of adrenal insufficiency in patients with endogenous Cushing syndrome receiving osilodrostat treatment combined with a replacement of glucocorticoid (block-and-replace approach). The investigators are also evaluating new biomarker steroids to reflect adequate osilodrostat dosing, the durability and safety, and clinical improvement during treatment. **Detailed Description:** Phase 1 (Titration): Participants will provide written informed consent and receive the first dose of osilodrostat (1-2 mg) in the evening. The following morning, participants will add treatment with at least a physiologic replacement dose of methylprednisolone (4-6 mg/d based on body size in not more than 2 divided doses) and concurrently continue 1-2 mg BID of osilodrostat. Frequent communication is maintained with each participant, at least twice weekly for the first 3 months and weekly thereafter until target osilodrostat dose is reached. Study personnel will ask targeted questions related to the primary endpoint with parameters to notify the study physicians for early signs of adrenal insufficiency. Participants are instructed to double their methylprednisolone dose for intercurrent illness and for symptoms of cortisol deficiency or withdrawal that do not resolve with pausing osilodrostat dosing. Every 4-12 weeks, an AM cortisol, as well as a research sample for steroid profiling (including 11OHA4), is obtained prior to the first doses of methylprednisolone and osilodrostat. The osilodrostat dose is up-titrated as necessary to achieve an AM cortisol goal of \<5 µg/dL. Once the AM cortisol is at goal, a late-night saliva cortisol (LNSC) and 24 h urine free cortisol (UFC) is obtained per standard of care. Osilodrostat titration is continued if necessary until the UFC is also at goal of \<10 µg/24h. Once the AM cortisol and UFC are at goals (\<5 µg/dL and \<10 µg/24h, respectively), the primary endpoint measures are completed, and the participant enters Phase 2. Phase 2 (Maintenance): Once the participant reaches what the investigator considers the maintenance doses of osilodrostat and methylprednisolone, participants are followed for a total of 48 weeks from the first osilodrostat dose before being considered at the end of study. The AM serum cortisol, UFC, and LNSC are repeated at the end of the 48-week period and as clinically indicated throughout Phase 2, generally every 3-6 months. ### Conditions Module **Conditions:** - Endogenous Cushing Syndrome - Adrenal Insufficiency - Hypercortisolism **Keywords:** - Osilodrostat - Glucocorticoid - Methylprednisolone - Medrol ### Design Module #### Bio Spec **Description:** Serum samples for steroid measurements. **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 12 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants with Cushing syndrome consented to participate in block-and-replace osilodrostat therapy. **Intervention Names:** - Drug: Osilodrostat **Label:** Observational cohort ### Interventions #### Intervention 1 **Arm Group Labels:** - Observational cohort **Description:** Add methylprednisolone to osilodrostat therapy after first dose and continue during osilodrostat titration. **Name:** Osilodrostat **Other Names:** - Isturisa **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** based on evidence of hypotension (systolic BP \<90 mmHg) and/or hypoglycemia (glucose \<45 mg/dL) with antecedent symptoms (examples: anorexia, nausea, abdominal pain, orthostasis) and with a resolution of signs upon receiving rescue glucocorticoid therapy **Measure:** Percent of participants who experience an adrenal insufficiency event during Phase 1 (titration phase) **Time Frame:** Through phase 1, approximately 24 weeks #### Secondary Outcomes **Description:** compare biomarkers measured by mass spectrometry. This may be calculated Upon 12 participants completing phase 1 or at the end of the study, whichever comes first. **Measure:** Correlation between AM cortisol and 11OHA4 measurements **Time Frame:** Up to end of study, approximately 48 weeks **Description:** based on evidence of hypotension (systolic BP \<90 mmHg) and/or hypoglycemia (glucose \<45 mg/dL) with antecedent symptoms (examples: anorexia, nausea, abdominal pain, orthostasis) and with a resolution of signs upon receiving rescue glucocorticoid therapy **Measure:** Adrenal insufficiency episodes during Phase 2 (maintenance) **Time Frame:** Up to end of phase 2 (approximately 48 weeks) **Description:** Based on patient-reported outcomes **Measure:** Frequency of cortisol withdrawal symptoms **Time Frame:** Up to end of phase 2 (approximately 48 weeks) **Description:** Based on clinic measurements **Measure:** Change in weight **Time Frame:** Baseline, end of phase 2 (approximately 48 weeks) **Description:** Based on clinic measurements **Measure:** Change in diastolic blood pressure **Time Frame:** Baseline, end of phase 2 (approximately 48 weeks) **Description:** Based on clinic measurements **Measure:** Change in systolic blood pressure **Time Frame:** Baseline, end of phase 2 (approximately 48 weeks) **Description:** Based on clinical laboratory measurements **Measure:** Change in HgbA1c **Time Frame:** Baseline, end of phase 2 (approximately 48 weeks) **Description:** Based on clinic notes, total number of medications used to treat Cushing syndrome comorbidities **Measure:** Change in number of concomitant medications **Time Frame:** Baseline, end of phase 2 (approximately 48 weeks) **Description:** Custom questionnaire for adrenal insufficiency- 4 Likert questions with scores ranging from 4-20. Higher scores indicate worse symptoms. **Measure:** Adrenal Insufficiency Assessment Questionnaire scores **Time Frame:** Up to end of study, approximately 48 weeks **Description:** The 36-Item Short Form Health Survey (SF-36) is standard RAND form used clinically. It is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 with higher scores indicating a better Health-related Quality of Life. **Measure:** RAND Short Form (SF)-36 scores **Time Frame:** Up to end of study, approximately 48 weeks **Description:** Investigators' judgment (1-5 scale) **Measure:** Ease of titration **Time Frame:** Up to end of phase 1 (approximately 48 weeks) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Endogenous Cushing syndrome, either following surgery or not candidates for surgery * Under consideration to receive osilodrostat as part of their clinical care * Able to provide informed consent. Exclusion Criteria: * Treatment with other investigational drugs within 30 days or five half-lives (whichever is longer). * A history of hypersensitivity to osilodrostat or therapies of a similar chemical class. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients receiving care at the University of Michigan. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Eyad Alsafadi **Phone:** 734-647-5661 **Role:** CONTACT #### Locations **Location 1:** **City:** Ann Arbor **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Eyad Alsafadi - **Phone:** 734-647-5661 - **Role:** CONTACT ***Contact 2:*** - **Name:** Richard Auchus, MD, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of Michigan **State:** Michigan **Status:** RECRUITING **Zip:** 48109 #### Overall Officials **Official 1:** **Affiliation:** University of Michigan **Name:** Richard Auchus, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000000307 - Term: Adrenal Gland Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M3661 - Name: Adrenal Insufficiency - Relevance: HIGH - As Found: Adrenal Insufficiency - ID: M6689 - Name: Cushing Syndrome - Relevance: HIGH - As Found: Cushing's Syndrome - ID: M3660 - Name: Adrenocortical Hyperfunction - Relevance: HIGH - As Found: Hypercortisolism - ID: M3659 - Name: Adrenal Gland Diseases - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: T1679 - Name: Cushing's Syndrome - Relevance: HIGH - As Found: Cushing's Syndrome - ID: T2879 - Name: Hyperadrenalism - Relevance: HIGH - As Found: Hypercortisolism ### Condition Browse Module - Meshes - ID: D000000309 - Term: Adrenal Insufficiency - ID: D000003480 - Term: Cushing Syndrome - ID: D000000308 - Term: Adrenocortical Hyperfunction ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AnEm - Name: Antiemetics - Abbrev: NeuroAg - Name: Neuroprotective Agents - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M14120 - Name: Prednisolone - Relevance: LOW - As Found: Unknown - ID: M9047 - Name: Glucocorticoids - Relevance: LOW - As Found: Unknown - ID: M11749 - Name: Methylprednisolone - Relevance: LOW - As Found: Unknown - ID: M1833 - Name: Methylprednisolone Acetate - Relevance: LOW - As Found: Unknown - ID: M11750 - Name: Methylprednisolone Hemisuccinate - Relevance: LOW - As Found: Unknown - ID: M229449 - Name: Prednisolone acetate - Relevance: LOW - As Found: Unknown - ID: M211887 - Name: Prednisolone hemisuccinate - Relevance: LOW - As Found: Unknown - ID: M248881 - Name: Prednisolone phosphate - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430515 **Brief Title:** The Clinical Efficacy and Safety of Intratumoral Injection of Chemotherapy for Advanced Solid Tumors **Official Title:** The Clinical Efficacy and Safety of Intratumoral Injection of Chemotherapy for Advanced Solid Tumors Through Fine Needle Puncture #### Organization Study ID Info **ID:** KY23197 #### Organization **Class:** OTHER **Full Name:** Wuxi People's Hospital ### Status Module #### Completion Date **Date:** 2028-12-31 **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:** 2027-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-09-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Wuxi People's Hospital #### 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 investigate the clinical efficacy of intra-tumoural injection of chemotherapeutic agents (e.g. cisplatin, oxaliplatin, etc.)via fine needle aspiration guided by CT or ultrasound in patients with advanced solid cancers to validate the safety and efficacy. **Detailed Description:** Malignant solid tumours including lung and liver cancers are the most common malignant tumours worldwide and have a very high mortality rate. Currently,the clinical practice mainly relies on systemic administration of chemotherapeutic agents usually by intravenous infusion for patients with solid cancer with multiple metastases,but the overall efficiency is not high.Single or multiple chemotherapeutic agents are infused intratumourally to increase the local drug concentration in the tumour, improve efficacy and reduce drug resistance and systemic adverse effects. This project intends to investigate the clinical efficacy of intra-tumoural injection of chemotherapeutic agents (e.g. cisplatin, oxaliplatin, etc.)via fine needle aspiration guided by CT or ultrasound in patients with advanced solid cancers to validate the safety and efficacy. ### Conditions Module **Conditions:** - Intratumoral Injection - Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Fine-needle puncture guided by CT or ultrasound and infusion of chemotherapeutic agents (e.g. cisplatin, oxaliplatin, etc.) via the tumour increases the local drug concentration in the tumour, improves therapeutic efficacy and reduces drug resistance and systemic adverse effects. **Intervention Names:** - Procedure: Intratumoral Injection of Chemotherapy **Label:** Intratumoral Injection of Chemotherapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intratumoral Injection of Chemotherapy **Description:** This project intends to investigate the clinical efficacy of intra-tumoural injection of chemotherapeutic agents (e.g. cisplatin, oxaliplatin, etc.)via fine needle aspiration guided by CT or ultrasound in patients with advanced solid cancers to validate the safety and efficacy. **Name:** Intratumoral Injection of Chemotherapy **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST1.1） **Measure:** Relief degree of tumors **Time Frame:** through study completion, an average of 5 year #### Secondary Outcomes **Description:** The duration from the beginning of treatment to cancer recurrence or progression **Measure:** Progress free survival（PFS） **Time Frame:** 3 years, year 3 **Description:** The duration from the beginning of treatment to patient death **Measure:** Overall survival（OS） **Time Frame:** 5 years, year 5 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Male or female aged 18-75 years; 2. Subjects must have histologically- or cytologically-confirmed diagnosis of advanced solid tumor(s) and have progressed on or is not eligible for available standard therapy; 3. Subjects have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (non-nodal lesions with longest diameter ≥ 10 mm, or nodal lesions with short diameter ≥ 15 mm); 4. ECOG score of 0-2, lifespan \> 12 weeks; 5. Women of childbearing age who have a negative pregnancy test within 7 days before treatment. Female patients of childbearing age, and male patients with partners of childbearing age must agree to use at least one medically recognized contraceptive method during study treatment and within at least 6 months after the last dose of investigational drug; 6. Voluntarily participated in this study, signed the informed consent form, had good compliance, and cooperated with the follow-up. Exclusion Criteria: 1. The patient is diagnosed with central nervous system leukemia(symptoms, signs, imaging, cerebrospinal fluid); 2. White blood cell count ≥ 50×10\^9/ L or patients with rapid disease progression can't be guaranteed to complete a full treatment cycle; 3. Patients with fungal, bacterial, viral or other uncontrollable infections or requiring four-level isolation treatment. 4. HIV, HBV and HCV positive; 5. Patients with diseases of the central nervous system or autoimmune central nervous system lesions, Including stroke, epilepsy, dementia; 6. Patients have myocardial infection, cardiac angiography or stents, active angina or other obvious clinical symptoms, or have cardiopathic asthma or cardiovascular lymphocytic infiltrates，within 12 months; 7. Patients are on anticoagulation or have severe coagulopathy (APTT\>70); 8. Patients in any condition requiring systemic treatment with corticosteroids or other immunosuppressive agents within 2weeks prior to investigational drug administration; 9. Subjects having any serious uncontrolled disease or in other conditions that would preclude them from receiving study treatment and are considered unsuitable for this study in the opinion of the investigator; 10. Subjects in other conditions that are considered unsuitable for this study by the investigator. **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:** Peihua Lu **Phone:** 13621500031 **Phone Ext:** +86 **Role:** CONTACT #### Locations **Location 1:** **City:** Wuxi **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Peihua Lu, MD - **Phone:** 13621500031 - **Role:** CONTACT **Country:** China **Facility:** Wuxi People's Hospital **State:** Jiangsu **Status:** RECRUITING **Zip:** 214043 ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M6182 - Name: Cisplatin - Relevance: LOW - As Found: Unknown - ID: M1674 - Name: Oxaliplatin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430502 **Brief Title:** Clinical Efficacy of Tumour Treatment Vaccine (TTV) Combined With PD-1 in the Treatment of Relapsed Refractory Advanced Solid Tumours **Official Title:** Clinical Efficacy of Tumour Treatment Vaccine (TTV) Combined With PD-1 in the Treatment of Relapsed Refractory Advanced Solid Tumours #### Organization Study ID Info **ID:** KY23189 #### Organization **Class:** OTHER **Full Name:** Wuxi People's Hospital ### Status Module #### Completion Date **Date:** 2027-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-07 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Wuxi People's Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study is intended to investigate the clinical efficacy of TTV vaccine combined with PD-1/PD-L1 inhibitor in the treatment of relapsed and refractory advanced solid tumours from a clinical perspective. **Detailed Description:** The innovative invention of Tumour Treatment Vaccine (TTV) has been verified in previous studies that the TTV vaccine can play a good role in enhancing the anti-tumour effect of immune checkpoint inhibitor therapy, and the tumour suppression rate of combined anti-PD-1 inhibitor reaches 75.96%. Therefore, this study is intended to investigate the clinical efficacy of TTV vaccine combined with PD-1/PD-L1 inhibitor in the treatment of relapsed and refractory advanced solid tumours from a clinical perspective. ### Conditions Module **Conditions:** - Cancer - PD-L1 Gene Mutation ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Tumor treatment vaccine(TTV) would be given deep subcutaneously in the arm or near the tumor. Use PD-1/L1 inhibitors in accordance with the drug indication. **Intervention Names:** - Biological: Tumor Treatment Vaccine; PD-1/L1 inhibitors **Label:** Tumor treatment vaccine combined with PD-1/L1 inhibitor for patients with advanced solid tumors **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Tumor treatment vaccine combined with PD-1/L1 inhibitor for patients with advanced solid tumors **Description:** Before and after the patient's treatment period using PD-1 inhibitors，patients will receive tumor treatment vaccine(TTV), which would be given deep subcutaneously in the arm or near the tumor.The initial dose is 1ml each time, if the reaction isn't obvious, the dose can be appropriately increased to 2.5-4.0ml each time.The interval between injections can be shortened or extended depending on the patient's condition and response. **Name:** Tumor Treatment Vaccine; PD-1/L1 inhibitors **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST1.1） **Measure:** Relief degree of tumors **Time Frame:** immediately after the last treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Male or female aged 18-75 years; 2. Subjects must have histologically- or cytologically-confirmed diagnosis of advanced solid tumor(s) and have progressed on or is not eligible for available standard therapy; 3. Subjects have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (non-nodal lesions with longest diameter ≥ 10 mm, or nodal lesions with short diameter ≥ 15 mm); 4. ECOG score of 0-2, lifespan \> 12 weeks; 5. Women of childbearing age who have a negative pregnancy test within 7 days before treatment. Female patients of childbearing age, and male patients with partners of childbearing age must agree to use at least one medically recognized contraceptive method during study treatment and within at least 6 months after the last dose of investigational drug; 6. Voluntarily participated in this study, signed the informed consent form, had good compliance, and cooperated with the follow-up. Exclusion Criteria: 1. The patient is diagnosed with central nervous system leukemia(symptoms, signs, imaging, cerebrospinal fluid); 2. White blood cell count ≥ 50×10\^9/ L or patients with rapid disease progression can't be guaranteed to complete a full treatment cycle; 3. Patients with fungal, bacterial, viral or other uncontrollable infections or requiring four-level isolation treatment. 4. HIV, HBV and HCV positive; 5. Patients with diseases of the central nervous system or autoimmune central nervous system lesions, Including stroke, epilepsy, dementia; 6. Patients have myocardial infection, cardiac angiography or stents, active angina or other obvious clinical symptoms, or have cardiopathic asthma or cardiovascular lymphocytic infiltrates，within 12 months; 7. Patients are on anticoagulation or have severe coagulopathy (APTT\>70); 8. Patients in any condition requiring systemic treatment with corticosteroids or other immunosuppressive agents within 2weeks prior to investigational drug administration; 9. Patients were infected with covid-19 within 2weeks prior to investigational drug administration; 10. Subjects having any serious uncontrolled disease or in other conditions that would preclude them from receiving study treatment and are considered unsuitable for this study in the opinion of the investigator; 11. Subjects in other conditions that are considered unsuitable for this study by the investigator. **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:** Peihua Lu **Phone:** 0510-85350495 **Role:** CONTACT #### Locations **Location 1:** **City:** Wuxi **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Peihua Lu, MD - **Phone:** 13621500031 - **Role:** CONTACT **Country:** China **Facility:** Wuxi People's Hospital **State:** Jiangsu **Status:** RECRUITING **Zip:** 214043 ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M17360 - Name: Vaccines - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430489 **Acronym:** PROTORISC **Brief Title:** Treatment of Suicidal Ideation in the Emergency Department Using Nitrous Oxide **Official Title:** Treatment of Suicidal Ideation in the Emergency Department Using Nitrous Oxide - PROTORISC Pilote #### Organization Study ID Info **ID:** DR230123 #### Organization **Class:** OTHER **Full Name:** University Hospital, Tours ### Status Module #### Completion Date **Date:** 2026-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-04-26 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Tours #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Suicide prevention is a major public health concern, with nearly 9,000 suicides and over 200,000 suicide attempts reported each year in France. Suicide attempts and suicidal ideation are among the most frequent reasons for emergency room visits and psychiatric hospitalizations. Although there is no approved pharmacological treatment for suicidal crises, some psychiatric treatments appear promising. Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has shown promising results in reducing suicidal ideation. However, its use is limited due to its side effects. Nitrous oxide, another NMDA receptor inhibitor commonly used in anesthesia and pain management, has demonstrated rapid antidepressant effects and few side effects. Given its rapid and lasting effects, nitrous oxide could swiftly alleviate suicidal ideation. ### Conditions Module **Conditions:** - Suicidal Ideation - Emergency Psychiatric - Nitrous Oxide ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Medical air **Label:** Control **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Intervention Names:** - Drug: Nitrous oxide **Label:** Experimental **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental **Description:** inhaled nitrous oxide (1 hour at 50% concentration) **Name:** Nitrous oxide **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Control **Description:** inhaled medical air (1 hour) **Name:** Medical air **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Suicidal ideation severity decrease (SSI) **Measure:** suicidal ideation severity **Time Frame:** At Hour 4 #### Secondary Outcomes **Description:** Suicidal ideation severity decrease (SSI): The score ranges from 0 to 38. The higher the total score, the greater the severity of suicide ideation **Measure:** suicidal ideation severity **Time Frame:** At Hour 24, at Hour 48, at Day 7 and at Month 1 **Measure:** Suicidal ideation assessed by the SSI scale. **Time Frame:** At Hour 24, at Hour 48, at Day 7 and at Month 1 **Measure:** Suicidal ideation assessed by the Columbia Suicidal Risk Severity Scale (C-SSRS). **Time Frame:** At Day 0 et Day 7 **Description:** The higher the total score, the greater the severity of depression **Measure:** Depressive symptoms measured by hetero-assessment using the "Montgomery-Asberg Depression Rating Scale" (MADRS). **Time Frame:** At Day 0 et Day 7 **Description:** The higher the total score, the greater the severity of depression **Measure:** Depressive symptoms measured by the "Patient Health Questionnaire" PHQ-9 self-administered questionnaire. **Time Frame:** At Day 0, At Hour 4, at Hour 24, at Hour 48 et at Day 7 **Description:** The higher the total score, the greater the severity of anxiety **Measure:** Intensity of anxiety measured by the "State and Trait Anxiety Inventory" (STAI) scale. **Time Frame:** At Day 0 up to Hour 4, at Hour 24, at Hour 48 et at Day 7 **Description:** The higher the score, the more the clinical condition has worsened **Measure:** Overall improvement measured by change in Clinical Global Impression - Improvement (CGI) scale score. **Time Frame:** At Day 0 up to Hour 4, at Hour 24, at Hour 48 et at Day 7 **Description:** Number of suicide attempts and methods in the month following the intervention **Measure:** Commitment to suicidal action in the month following inclusion **Time Frame:** in the month following Day 0 **Measure:** Consumption of psychotropic medication for anxiolytic or sedative purposes. **Time Frame:** At Hour 0 up to Hour 4 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Active suicidal ideations * Beck Scale for Suicidal Ideation score greater than or equal to 8 * French speaking * Patient admitted to psychiatric emergency department * Capable of wearing a facial mask * Having signed an informed consent * Affiliated with social security Exclusion Criteria: * Psychotic disorder, neurodegenerative disease, known substance use disorder (excluding caffeine or tobacco), substance intoxication, unstable somatic pathology * Pregnancy or breastfeeding * Contraindication to the use of nitrous oxide * Legal incapacity * Participation in another drug clinical trial * Patient subject to compulsory care measures **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** ANAIS VANDEVELDE, MD, PHD **Phone:** +33247474747 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Stellina AUGIS **Phone:** 02.47.47.46.38 **Phone Ext:** +33 **Role:** CONTACT #### Locations **Location 1:** **City:** Tours **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** ANAÏS VANDEVELDE, MD PhD - **Phone:** 02.47.47.95.08 - **Phone Ext:** +33 - **Role:** CONTACT **Country:** France **Facility:** Psychiatric Emergencies **Zip:** 37044 #### Overall Officials **Official 1:** **Affiliation:** CHRU de Tours **Name:** ANAIS VANDEVELDE, MD, PHD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000013405 - Term: Suicide - ID: D000016728 - Term: Self-Injurious Behavior - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M7796 - Name: Emergencies - Relevance: HIGH - As Found: Emergency - ID: M29364 - Name: Suicidal Ideation - Relevance: HIGH - As Found: Suicidal Ideation - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M16191 - Name: Suicide - Relevance: LOW - As Found: Unknown - ID: M19089 - Name: Self-Injurious Behavior - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004630 - Term: Emergencies - ID: D000059020 - Term: Suicidal Ideation ### Intervention Browse Module - Ancestors - ID: D000018685 - Term: Anesthetics, Inhalation - ID: D000018681 - Term: Anesthetics, General - ID: D000000777 - Term: Anesthetics - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018712 - Term: Analgesics, Non-Narcotic - ID: D000000700 - Term: Analgesics - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M12546 - Name: Nitrous Oxide - Relevance: HIGH - As Found: Cleared - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M20765 - Name: Anesthetics, Inhalation - Relevance: LOW - As Found: Unknown - ID: M20761 - Name: Anesthetics, General - 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 ### Intervention Browse Module - Meshes - ID: D000009609 - Term: Nitrous Oxide ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430476 **Brief Title:** EMI Therapy for Depression in Hong Kong **Official Title:** Ecological Momentary Intervention (EMI) as Augmentative Therapy for Depression in Clinical Sample in Hong Kong #### Organization Study ID Info **ID:** EMI_depression #### Organization **Class:** OTHER **Full Name:** The University of Hong Kong ### Status Module #### Completion Date **Date:** 2024-08-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-05 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-03 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-08-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-31 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The University of Hong Kong #### 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 if a two-week ecological momentary intervention (two EMA + one EMI daily) as augmentation to treatment as usual would reduce depressive symptoms, rumination levels, and functioning in subjects with mild to moderate depression, as compared to active controls receiving three EMA prompts daily. **Detailed Description:** Background: Major Depressive Disorder (MDD) is the leading contributors to disability-adjusted life years, with a burden comparable to that of cardiovascular disease. Among the core symptoms of MDD, rumination stands out as a particularly pernicious factor. Rumination is dysfunctional disturbing thinking; a maladaptive pattern of regulating thoughts and emotions characterized by a repetitive focus on negative thoughts, such as dwelling on negative memories and analyzing events without taking actions. Rumination amplifies negative cognitions and attenuates the effect of adapting problem-solving strategy, decreasing the motivation of patients to cope with stressful encounters and become more vulnerable to momentary low mood. Interventional strategies (such as Cognitive Bias Modification) targeting rumination involves increases one's ability to become aware of their own rumination and supporting them to adapt alternative thinking habits. Complementary techniques such as mindfulness and relaxation do not involve the reframing of negative thoughts but rather promote the acceptance of these thoughts, in this way, it allows one become more aware of distractions and repetitive past or future thinking events. The ESM, a structured self-report diary technique several times a day over a number of days using mobile devices zooming in on the micro-level of experience and behavior, presents a novel and promising approach to accurately track symptoms and experience by minimizing recall bias and capturing the natural fluctuations of symptom on a more immediate, granular level. The ESM-derived intervention (ESM-I), uses personalized mobile feedback to effectively treat depressive symptoms. Importantly, increasing evidence from randomised controlled trials (RCTs) have shown ESM-I as effective means to augment interventions in depression. While improving rumination is key the core depression symptom, ESM-I has yet to specifically target rumination, and the mechanisms by which ESM-I exert therapeutic effects warrant further investigation. Objectives: Our study aims to investigate the efficacy of a newly developed smartphone based 2-week Ecological Momentary Intervention (EMI) in comparison with an active control group receiving only ESM, as an innovative, online-based, accessible, and augmentative treatment for depression. This intervention is designed to be both timely and adaptive, targeting the core symptom of anhedonia in a clinical sample within Hong Kong. Design: This is a single-center, randomized, double-blind, sham-controlled trial with three assessment time points: Baseline (T0), post-intervention (T1) and 1-month post-intervention (T2). Ecological Momentary Assessment (EMA): After providing informed consent, participants will install the "m-path" smartphone-based application, which is an open-source ESM program developed by KU Leuven. Following a briefing and practise run, participants will be randomly prompted within designated 3-hour blocks three times daily to complete a 5-minute questionnaire assessing their momentary affect, rumination levels, and suicidality, using visual analogue scales ranging from 0 (lowest) to 100 (highest). There will be 14 EMA questions covering affect (8 questions), suicidality (2 questions), and rumination (4 questions). Ecological Momentary Intervention (EMI): Embedded within the last EMA survey, the EMI arm will include interactive tasks when a participant's computed rumination score (i.e., mean score of the four EMA rumination questions) reaches above the 80th percentile of their own cumulative score, or if the raw rumination score reach above 70 out of 100. The intervention comprises of short exercises (most can be completed within 1-3 minutes) rooted in cognitive bias modification (CBM) techniques. Participants will interact with instructions and multimedia formats based on CBM module framework based on reflection / brooding. Participants will continue treatment with their psychiatrists who will be blinded to group allocation. Variables: * Hamilton Depression Rating Scale (HDRS) * Montgomery-Åsberg Depression Rating Scale (MADRS) * Social and Occupational Functioning Assessment scale (SOFAS) * Role Functioning Scale (RFS) * Global Functioning: Social Scale and Role Scale * Short Form Health Survey (SF-12) * General Self Efficacy Scale * Rumination Response Scale (RRS) * System Usability Scale - Chinese version * Beck Scale for Suicidal Ideation ### Conditions Module **Conditions:** - Mild to Moderate Depression **Keywords:** - Depression - Ecological momentary intervention - Rumination - Hong Kong ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** EMA arm: participants will receive three ecological momentary assessment (EMA) prompts daily with the prompts spread out throughout the day. Within each prompt, participants will answer 14 questions regarding affect, suicidality, and rumination. Afterwards, they will be shown a video clip extracted from a popular and longstanding soap opera in Chinese that lasts between three to four minutes. Each prompt would take around 8 minutes to complete. In total, participants will complete 70 EMA prompts during the intervention period. EMI arm: participants will receive two EMA prompts and one EMI prompt daily. The EMA prompts would be identical to the ones in the EMA arm without the video clip at the end. The EMI prompt would contain an interactive task designed to counter ruminative thoughts. ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** masking: Participants will be notified that they would engage in a diary recording activity for two weeks, but would be blinded to whether they were receiving the intervention or active control version. Participants will also be instructed not to reveal their exercise components (i.e., relaxation exercises or rumination exercises) to the trained research assistants, who will also be responsible for obtaining outcomes. Trained research assistents would assess outcomes and the principal investigator would randomise participants to the two conditions based on anonymised IDs. Treatment provided to participants as usual by their usual care providers (e.g., doctors) would not be notified about the randomisation conditions. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Ecological momentary assessment (EMA) arm: participants will receive three ecological momentary assessment (EMA) prompts daily within three time blocks spread out throughout the day. Within each prompt, participants will answer 14 questions regarding affect, suicidality, and rumination. Afterwards, they will be shown a video clip extracted from a popular and longstanding soap opera in Chinese that lasts between three to four minutes. Each prompt would take around 8 minutes to complete. In total, participants will complete 70 EMA prompts during the intervention period. **Intervention Names:** - Other: EMA **Label:** EMA **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** EMI arm: participants in this arm will receive two ecological momentary assessment (EMA) prompts and one econological momentary intervention (EMI) prompt daily. The EMA prompts would be identical to the ones in the EMA arm without the video clip at the end. The EMI prompt would contain an interactive task designed to counter ruminative thoughts. Examples of the interactive tasks include: mindfulness exercises (mindful walking), cognitive reappriasal, strengths recognition, etc. Each EMI prompt would last around 3-5 minutes. **Intervention Names:** - Other: EMI **Label:** EMI **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - EMI **Description:** A phone-based intervention containing exercises meant to reduce ruminative thoughts carried out on an experience sampling platform m-Path **Name:** EMI **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - EMA **Description:** A phone-based exercise containing relaxation videos carried out on an experience sampling platform m-Path **Name:** EMA **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Gold standard for measuring depressive symptoms, score ranges from 0 (minimum) to 53 (maximum); higher score indicates more severe depressive symptoms. **Measure:** Hamilton Depression Rating Scale (HDRS) - 17 items **Time Frame:** T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up) **Description:** Average score among the following aspects: positive and negative affect (four questions each), active and passive suicidality (one question each), rumination (four questions); score ranges from 0 (minimal) to 100 (maximum), with a higher score indicating a greater value of measured aspect. **Measure:** Ecological Momentary Assessment (EMA) outcomes **Time Frame:** During intervention #### Secondary Outcomes **Description:** Measures social and occupational functioning across work functioning, independent functioning, immediate and extended social network functioning; score ranges from 0 (minimum) to 100 (maximum), higher score indicates higher social and occupational functioning ability. **Measure:** Social and Occupational Functioning Assessment scale (SOFAS) **Time Frame:** T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up) **Description:** Measures role functioning in four areas: work productivity, independent living, immediate and extended social network relationships; score ranges from 0 (minimum) to 7 (maximum) on each aspect, higher score indicates better role functioning **Measure:** Role Functioning Scale (RFS) **Time Frame:** T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up) **Description:** Measures social and role functioning; score ranges from 1 (minimum) to 10 (maximum); higher score indicates better social/role functioning **Measure:** Global Functioning: Social Scale and Role Scale **Time Frame:** T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up) **Description:** Measures impacts of overall physical and emotional health on individuals' day to day living; score ranges from 0 (minimum) to 100 (maximum), higher score indicates better physical and mental health functioning **Measure:** Short Form Health Survey (SF-12) **Time Frame:** T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up) **Description:** Measures self-reported self-efficacy; score ranges from 10 (minimum) to 40 (maximum), with higher scores indicating more self-efficacy **Measure:** General Self Efficacy Scale **Time Frame:** T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up) **Description:** Measures self-reported rumination responses; score ranges from 10 (minimum) to 40 (maximum), with higher scores indicating higher levels of ruminative responses styles. **Measure:** Rumination Response Scale (RRS) **Time Frame:** T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up) **Description:** Measures self-reported suicidal ideation; score ranges from 0 (minimum) to 38 (maximum), with higher scores indicating a greater risk of suicide. **Measure:** Beck Scale for Suicidal Ideation **Time Frame:** T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up) **Description:** to assess acceptability and feedback regarding conducting EMA and EMI on mPath platform; scores ranges from 10 (minimum) to 50 (maximum), with higher scores indicating higher perceived usability of the systems involved. **Measure:** System Usability Scale - Chinese version **Time Frame:** T1 (immedately after intervention); T2 (one-month after intervention follow-up) **Description:** Measures the severity of illness and global improvement following an intervention; scores ranges from 1 (normal/very much improved) to 7 (most severely ill/very much worse), with higher scores indicating worse outcome. **Measure:** Clinical Global Impression Scale **Time Frame:** T1 (immedately after intervention); T2 (one-month after intervention follow-up) **Description:** Measuring change in depressive symptoms; score ranges from 0 (minimum) to 60 (maximum); higher score indicates more severe depressive symptoms. **Measure:** Montgomery-Åsberg Depression Rating Scale (MADRS) **Time Frame:** T0 (baseline); T1 (immedately after intervention); T2 (one-month after intervention follow-up) **Description:** A four-question self-rated scale; measures intervention expectancy and credibility of intervention used; score ranges from 1 - 9 for questions 1-3 in the and from 0% to 100% for the last question. A higher value or percentage indicates higher agreement with the statement in the question. **Measure:** Credibility Expectancy Questionnaire (CEQ) - Chinese translated **Time Frame:** Immediately after first day of intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged 16-65 years * Cantonese-speaking ethnic Chinese * Diagnosis of major depressive episode (MDE) established by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorder 5th Edition (DSM-V) * 17-item Hamilton Depression Rating Scale (HDRS) ≥ 14 at screening and at baseline (i.e. moderate to severe depression) * Having a smartphone with Internet access and iOS or Android operating system. Exclusion Criteria: * Patients who could not read Chinese, are unable to provide informed consents * Comorbid with other Axis I diagnoses (especially schizoaffective disorder) * With an unstable medical condition or current substance abuse * Have a score of ≥4 on any one of the three items on Positive and Negative Syndrome Scale (P1 Delusion, P2 Conceptual disorganization, P3 Hallucination) * Marked risk of self-harm or suicide that could not be safely managed in an outpatient clinic setting * Currently receiving any other weekly psychosocial therapy * Unable to use a smartphone-based application due to cognitive impairment or learning disability or inadequate vision. **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 16 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Hong Kong **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ka Ying Heidi Lo - **Phone:** 2255 4486 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Phone:** 2255 4486 - **Role:** CONTACT **Country:** Hong Kong **Facility:** University of Hong Kong **Status:** RECRUITING ### References Module #### References **Citation:** Morosini PL, Magliano L, Brambilla L, Ugolini S, Pioli R. Development, reliability and acceptability of a new version of the DSM-IV Social and Occupational Functioning Assessment Scale (SOFAS) to assess routine social functioning. Acta Psychiatr Scand. 2000 Apr;101(4):323-9. **PMID:** 10782554 **Citation:** Wang, Y., Lei, T., & Liu, X. (2020). Chinese System Usability Scale: Translation, Revision, Psychological Measurement. International Journal of Human-Computer Interaction, 36(10), 953-963. https://doi.org/10.1080/10447318.2019.1700644 **Citation:** American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). https://doi.org/10.1176/appi.books.9780890425596 **Citation:** Mestdagh M, Verdonck S, Piot M, Niemeijer K, Kilani G, Tuerlinckx F, Kuppens P, Dejonckheere E. m-Path: an easy-to-use and highly tailorable platform for ecological momentary assessment and intervention in behavioral research and clinical practice. Front Digit Health. 2023 Oct 18;5:1182175. doi: 10.3389/fdgth.2023.1182175. eCollection 2023. **PMID:** 37920867 **Citation:** Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4. **PMID:** 11132119 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms - 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 - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depression - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M2062 - Name: Rumination Syndrome - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: T5077 - Name: Rumination Disorder - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003863 - Term: Depression - ID: D000003866 - Term: Depressive Disorder ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430463 **Brief Title:** Impact of Interscalenous Block Anesthesia on Hearing **Official Title:** Effect of Interscalenous Block Anesthesia on Hearing Levels #### Organization Study ID Info **ID:** 02-2024/11 #### Organization **Class:** OTHER **Full Name:** Karaman Training and Research Hospital ### Status Module #### Completion Date **Date:** 2024-11-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-06 **Type:** ESTIMATED **Last Update Submit Date:** 2024-06-05 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-11-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-05 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Karaman Training and Research Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Interscalene brachial plexus block (ISBPB) is used frequently in shoulder, clavicle and upper arm surgeries to obtain analgesia in the postoperative period. Our primary aim in this study is to evaluate if interscalene block anesthesia has an effect on hearing levels of patients undergoing orthopedic shoulder surgeries. **Detailed Description:** Interscalene brachial plexus block (ISBPB) is used for both anesthesia and analgesia purposes in shoulder, clavicle and upper arm surgeries. It is also frequently used to obtain analgesia in the postoperative period especially in patients undergoing shoulder surgeries. Thus, it provides decrease in opioid need and opioid related side effects in the perioperative period. The effect of IBPB on hearing is probably not caused by an effect on the vestibulocochlear nerve because of its central location. The innervation area of the greater auricular nerve, a derivative of the cervical plexus, is often involved in an IBPB. However, this nerve is not known to affect hearing. The nerves supplying the outer ear canal and the tympanic membrane (branches of the mandibular, facial and vagal nerves) are located far enough from the IBPB injection site to make their involvement unlikely. However, sound conduction through the middle ear to the inner ear, and functioning of the spiral organ of the cochlea may be indirectly affected by regional sympathetic block that is most likely seen after IBPB. Sympathetic block may cause vasodilatation and swelling of the mucosal membranes of the middle ear and the eustachian tube with deterioration of hearing. The patient will be examined by ENT physician on the morning of the operation, after a detailed anamnesis. otoscopic examination will be performed, pure tone audiometry, speech audiometry and tympanometric examination will be performed and recorded.The same tests will be performed at the next day after the surgery but before the discharge and also when he/she applies for the first week check-up. Ultrasaoun guided Interscalene block anesthesia will be applied to all patients. Each patient will be treated with the same multimodal analgesia method at the postoperative period. ### Conditions Module **Conditions:** - Hearing Loss **Keywords:** - hearing level - interscalene block anesthesia ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Ultrasound-guided Interscalene block will be applied to all patientsand also every patients will be treated with the same multimodal analgesia for postoperative pain control. The patient will be examined by ENT physician on the morning of the operation, after a detailed anamnesis. otoscopic examination will be performed, pure tone audiometry, speech audiometry and tympanometric examination will be performed and recorded.The same tests will be performed at the next day after the surgery but before the discharge and also when he/she applies for the first week check-up. **Intervention Names:** - Diagnostic Test: pure tone audiometry levels **Label:** patients undergoing shoulder surgery with interscalene block ### Interventions #### Intervention 1 **Arm Group Labels:** - patients undergoing shoulder surgery with interscalene block **Description:** The patient will be examined by ENT physician on the morning of the operation, otoscopic examination will be performed, pure tone audiometry, speech audiometry and tympanometric examination will be performed and recorded.The same tests will be performed at the next day after the surgery but before the discharge and also when he/she applies for the first week check-up. **Name:** pure tone audiometry levels **Other Names:** - speech audiometry - tympanometry - otoscopic examnation **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** pure tone audiometry measurements at all frequencies measured via MADSEN Astera2 device **Measure:** Number of Participants with a Difference of 10 dB or more between Pre- and Post-surgery pure tone audiometry measurements at any Frequency **Time Frame:** pre-surgery, a day after surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * participants are undergoing a shoulder surgery. * ASA I and II patients without uncontrolled diabetes and hypertension * participants have normal or near-normal hearing thresholds in the un-operated ear Exclusion Criteria: * participants have hearing loss (PTA \> 35 dB HL) in pure tone audiometry testing before surgery in any side * participants have medical conditions after the surgery which prevents having hearing tests * participants have abnormal tympanometric results * participants with chronic otitis media or a history of ear surgery **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Participants undergoing shoulder surgery with ultrasoun-guided interscalene brachial plexus block. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Arife Sezgin **Phone:** +905304069461 **Role:** CONTACT #### Locations **Location 1:** **City:** Karaman **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Arife Sezgin - **Phone:** 5304069461 - **Role:** CONTACT ***Contact 2:*** - **Name:** Arife Sezgin - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Umman Menendi - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Tayfun Et - **Role:** SUB_INVESTIGATOR ***Contact 5:*** - **Name:** Betül Başaran - **Role:** SUB_INVESTIGATOR ***Contact 6:*** - **Name:** Fatih Yücedağ - **Role:** SUB_INVESTIGATOR **Country:** Turkey **Facility:** Karaman training and research hospital **State:** Merkez **Status:** RECRUITING **Zip:** 70200 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006311 - Term: Hearing Disorders - ID: D000004427 - Term: Ear Diseases - ID: D000010038 - Term: Otorhinolaryngologic Diseases - ID: D000012678 - Term: Sensation Disorders - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M24420 - Name: Hearing Loss - Relevance: HIGH - As Found: Hearing Loss - ID: M6840 - Name: Deafness - Relevance: LOW - As Found: Unknown - ID: M9400 - Name: Hearing Disorders - Relevance: LOW - As Found: Unknown - ID: M7601 - Name: Ear Diseases - Relevance: LOW - As Found: Unknown - ID: M12961 - Name: Otorhinolaryngologic Diseases - 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 ### Condition Browse Module - Meshes - ID: D000034381 - Term: Hearing Loss ### 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:** NCT06430450 **Brief Title:** Determination of Salivary Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible Factor-1 Alpha (HIF-1α), E-cadherin, Galectin 3, IL-4, IL-10 and TNF-α Levels in Individuals With Different Degrees of Periodontal Disease **Official Title:** Determination of Salivary Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible Factor-1 Alpha (HIF-1α), E-cadherin, Galectin 3, IL-4, IL-10 and TNF-α Levels in Individuals With Different Degrees of Periodontal Disease #### Organization Study ID Info **ID:** ISMAILKMU #### Organization **Class:** OTHER **Full Name:** Karamanoğlu Mehmetbey University ### Status Module #### Completion Date **Date:** 2025-01-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-11-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Karamanoğlu Mehmetbey University #### Responsible Party **Investigator Affiliation:** Karamanoğlu Mehmetbey University **Investigator Full Name:** İsmail Taşdemir **Investigator Title:** Assistant professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The aim of this clinical study is; Comparatively comparing salivary Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible factor-1 alpha (HIF-1α), E-cadherin, galectin 3, IL-4, IL-10 and TNF-α levels in individuals with different Periodontal Disease Degrees and to evaluate and analyze correlations with clinical parameters. In our study, saliva samples will be taken from a total of 80 systemically healthy volunteers, 20 of patients are periodontal healthy, 20 of patients have degree A periodontitis, 20 of patients have degree B periodontitis and 20 of patients have degree C periodontitis, along with the measurement of whole mouth clinical parameters. Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible factor-1 alpha (HIF-1α), E-cadherin, galectin 3, IL-4, IL-10 and TNF-α levels in the samples taken will be subjected to enzyme-related immunoassay ( It will be determined by ELISA). Cytokine levels between different groups will then be interpreted as a result of statistical analysis. Possible significant differences shed light on future studies with Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible factor-1 alpha (HIF-1α), E-cadherin, galectin 3, IL-4, IL-10 and TNF-α. These cytokines may help develop different diagnostic methods or treatment strategies in future periodontal treatments. **Detailed Description:** The study included patients between the ages of 18 and 70 who applied to Karamanoğlu Mehmetbey University Ahmet Keleşoğlu Faculty of Dentistry Department of Periodontology, were non-smokers, had no systemic problems, had not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 3 months, were not pregnant, had not received periodontal treatment in the last 6 months, and having at least 20 teeth in its mouth; for grade A periodontitis group; 20 individuals with a probing pocket depth of 5 mm or more in at least 2 teeth in each quadrant of the jaw, attachment loss, and radiological bone loss percentage/age ratio \<0.25 in the tooth with the most bone loss; for grade B periodontitis group; 20 individuals with a probing pocket depth of 5 mm or more in at least 2 teeth in each quadrant jaw, attachment loss, and a radiological bone loss percentage/age ratio of 0.25-1.0 in the tooth with the most bone loss; for grade C periodontitis group; 20 individuals with a probing pocket depth of 5 mm or more in at least 2 teeth in each quadrant of the jaw, attachment loss, and radiological bone loss percentage/age ratio \>1.0 in the tooth with the most bone loss; For the healthy group; According to the evaluation made in 6 regions of each tooth, including 20 individuals who show bleeding on probing in less than 20% of the area, have a probing depth of less than 4 mm, and have no attachment loss. The healthy and periodontal disease group will consist of 80 patients in total.Anamnesis will be taken from individuals at the beginning of the interview, and individuals who meet the specified criteria after the anamnesis will be included in the study. After being informed about the study, an informed consent form will be obtained from the individuals. After the anamnesis is taken, clinical periodontal evaluations will be performed on individuals who are deemed to meet the inclusion criteria. Clinically, plaque index (Sillness and Löe 1964), gingival index (Löe and Sillness 1963), pocket depth and bleeding on probing index(Ainamo\&Bay, 1975) will be recorded. Saliva samples will be taken from individuals divided into groups for biochemical examinations. Saliva samples will be taken from each patient, first frozen at -20ºC and than stored at -28ºC until the day of analysis. Cytokine levels in the samples collected from the patients will be determined by the enzyme-related immune test "Enzyme Linked-Immuno-Sorbent Assay" (ELISA). ### Conditions Module **Conditions:** - Periodontitis - Periodontal Diseases **Keywords:** - Periodontitis - Saliva - Cytokine ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 5 Months ### Arms Interventions Module #### Arm Group 1 **Description:** Individuals who have no clinical signs of inflammation in the periodontal tissues and the number of areas showing bleeding on probing does not exceed 20%. **Intervention Names:** - Diagnostic Test: Clinical measurements and saliva samples collection **Label:** Healty #### Arm Group 2 **Description:** Individuals with a probing pocket depth of 5 mm or more in at least 2 teeth in each quadrant of the jaw, attachment loss, and radiological bone loss percentage/age ratio in the tooth with the most bone loss \<0.25 **Intervention Names:** - Diagnostic Test: Clinical measurements and saliva samples collection **Label:** Grade A #### Arm Group 3 **Description:** Individuals with a probing pocket depth of 5 mm or more in at least 2 teeth in each quadrant jaw, attachment loss, and a radiological bone loss percentage/age ratio of 0.25-1.0 in the tooth with the most bone loss. **Intervention Names:** - Diagnostic Test: Clinical measurements and saliva samples collection **Label:** Grade B #### Arm Group 4 **Description:** Individuals with a probing pocket depth of 5 mm or more in at least 2 teeth in each quadrant of the jaw, attachment loss, and a radiological bone loss percentage/age ratio \>1.0 in the tooth with the most bone loss. **Intervention Names:** - Diagnostic Test: Clinical measurements and saliva samples collection **Label:** Grade C ### Interventions #### Intervention 1 **Arm Group Labels:** - Grade A - Grade B - Grade C - Healty **Description:** Clinical measurements will be taken from all patients and saliva samples will be collected for biochemical analysis. **Name:** Clinical measurements and saliva samples collection **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Comparatively comparing salivary Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible factor-1 alpha (HIF-1α), E-cadherin, galectin 3, IL-4, IL-10 and TNF-α levels in individuals with different Periodontal Disease Degrees. To examine and determine the correlation of these cytokines with clinical measurements. **Measure:** Outcome 1 **Time Frame:** First 5 months #### Secondary Outcomes **Description:** By investigating the changes in these cytokine levels in the presence of periodontal disease, they can be used in disease diagnosis in the future or to provide preliminary information on possible treatments that can be performed through these cytokine pathways. **Measure:** Outcome 2 **Time Frame:** Two months after the study was completed ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with a varying degree of periodontal status (periodontally healthy, gingivitis, and chronic periodontitis). * Have no systemic disease. * No smoking/ not using any tobacco products or alcohol. * No periodontal therapy in last 6 months. * Not using any anti-inflammatory drugs in last 3 months and antibiotics in last 6 months. * Not to be pregnant or in lactation period. * Having ≥20 permanent teeth. Exclusion Criteria: * Having any systemic disease. * Smokers, other tobacco product, and alcohol consumers. * Having any periodontal therapy in last 6 months. * Using any anti-inflammatory drugs in last 3 months and antibiotics in last 6 months. * Being pregnant or in lactation period. * Having ˂20 permanent teeth. **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** * 20 healty patients * 20 Grade A periodontitis * 20 Grade B periodontitis * 20 Grade C periodontitis ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** ismail taşdemir, assistant professor **Phone:** +905455694573 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000012818 - Term: Signs and Symptoms, Respiratory ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC07 - Name: Mouth and Tooth Diseases ### Condition Browse Module - Browse Leaves - ID: M4185 - Name: Hypoxia - Relevance: HIGH - As Found: Hypoxia - ID: M13427 - Name: Periodontitis - Relevance: HIGH - As Found: Periodontitis - ID: M13419 - Name: Periodontal Diseases - Relevance: HIGH - As Found: Periodontal Diseases - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M15623 - Name: Signs and Symptoms, Respiratory - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010518 - Term: Periodontitis - ID: D000010510 - Term: Periodontal Diseases - ID: D000000860 - Term: Hypoxia ### 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 ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430437 **Brief Title:** A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations **Official Title:** A Randomized, Open-Label, Multicenter Phase III Study of SHR-A1811 for First-Line Treatment in Subjects With HER2-Mutated Advanced or Metastatic Non-Small Cell Lung Cancer #### Organization Study ID Info **ID:** SHR-A1811-310 #### Organization **Class:** INDUSTRY **Full Name:** Jiangsu HengRui Medicine Co., Ltd. ### Status Module #### Completion Date **Date:** 2027-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-02 **Type:** ESTIMATED #### Start Date **Date:** 2024-08 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Jiangsu HengRui Medicine Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The study is being conducted to evaluate the efficacy, and safety of SHR-A1811 versus Standard of Care as first-line treatment of advanced or metastatic Non-Small Cell Lung Cancer with HER2- Mutations ### Conditions Module **Conditions:** - Non-Small Cell Lung Cancer With HER2- Mutations ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: SHR-A1811 **Label:** SHR-A1811 **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Camrelizumab、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin **Label:** Standard of Care（Camrelizumab、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin） **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - SHR-A1811 **Description:** Drug: SHR-A1811 administered intravenously every 3 weeks (Q3W) **Name:** SHR-A1811 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Standard of Care（Camrelizumab、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin） **Description:** Drug: Camrelizumab administered intravenously every 3 weeks (Q3W) Drug: Pemetrexed Based on the investigator's choice was administered intravenously every 3 weeks (Q3W) Drug: Paclitaxel Based on the investigator's choice was administered intravenously every 3 weeks (Q3W) Drug: Carboplatin Based on the investigator's choice was administered intravenously every 3 weeks (Q3W) Drug: Cisplatin Based on the investigator's choice was administered intravenously every 3 weeks (Q3W) **Name:** Camrelizumab、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Defined as time from randomization until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR) **Measure:** Progression-free survival (PFS) based on blinded independent central review (BICR) **Time Frame:** Until progression, assessed up to approximately 2 years #### Secondary Outcomes **Description:** Defined as time from randomization until the date of death due to any cause **Measure:** Overall Survival (OS) **Time Frame:** Until death, assessed up to approximately 3 years **Description:** Defined as time from randomization until progression per RECIST 1.1 as assessed by the investigator **Measure:** Progression Free Survival (PFS) by investigator assessment **Time Frame:** Until progression, assessed up to approximately 2 years **Description:** Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 **Measure:** Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) **Time Frame:** until to 90 days after the last dose，assessed up to approximately 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Able and willing to provide a written informed consent 2. 18-75 years old (inclusive of both ends) 3. ECOG score of 0 or 1. 4. Patients with histologically or cytologically confirmed advanced or metastatic NSCLC. 5. Subjects with central laboratory- confirmed functional HER2 mutations 6. No prior systemic antitumor therapy (including investigational agents) for advanced or metastatic NSCLC. 7. Have at least one measurable lesion outside the central nervous system that meets the criteria defined by RECIST v1.1 8. Protocol-defined adequate organ function including cardiac, renal, hepatic function Exclusion Criteria: 1. Mixed lung cancer with small cell components and sarcomatoid carcinoma confirmed by histology or cytology. 2. Concurrently carrying other driver gene mutations, and targeted drugs for such driver gene mutations have been approved for market release. 3. Subjects with untreated or active metastasis of central nervous system (CNS) tumors, or a history of meningeal metastasis or current meningeal metastasis. 4. With poorly controlled tumor-related pain. 5. previous or current with other malignancies. 6. Subjects with a history of interstitial pneumonia/non-infectious pneumonia requiring hormone therapy, or current interstitial pneumonia/non-infectious pneumonia. 7. Subjects with active or previous autoimmune diseases. 8. Subjects with uncontrolled or severe cardiovascular diseases. 9. Subjects with active hepatitis B or hepatitis C. **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:** You Li **Phone:** 0518-81220121 **Role:** CONTACT #### Locations **Location 1:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Name:** Shun Lu - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** Shanghai Chest Hospital **State:** Shanghai **Zip:** 200030 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## 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 ### 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: Non-Small Cell Lung Cancer - 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 ### Intervention Browse Module - Ancestors - ID: D000000972 - Term: Antineoplastic Agents, Phytogenic - ID: D000000970 - Term: Antineoplastic Agents - ID: D000050257 - Term: Tubulin Modulators - ID: D000050256 - Term: Antimitotic Agents - ID: D000050258 - Term: Mitosis Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000005493 - Term: Folic Acid Antagonists - ID: D000019384 - Term: Nucleic Acid Synthesis 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: M19537 - Name: Paclitaxel - Relevance: HIGH - As Found: Surgery - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M6182 - Name: Cisplatin - Relevance: LOW - As Found: Unknown - ID: M18650 - Name: Carboplatin - Relevance: HIGH - As Found: System - ID: M264 - Name: Pemetrexed - Relevance: HIGH - As Found: New - ID: M26197 - Name: Tubulin Modulators - Relevance: LOW - As Found: Unknown - ID: M26196 - Name: Antimitotic 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: 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: D000017239 - Term: Paclitaxel - ID: D000016190 - Term: Carboplatin - ID: D000068437 - Term: Pemetrexed ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430424 **Acronym:** GBrecurr **Brief Title:** Study of Metabolic, Transcriptomic and Proteomic Characteristics in Relapsed Glioblastoma **Official Title:** Study of Metabolic, Genomic and Proteomic Modifications in Relapsed Glioblastoma. Identification or Prognostic Markers in Patients Undergoing Surgery for Relapsed Glioblastoma. #### Organization Study ID Info **ID:** CHUBX 2023/79 #### Organization **Class:** OTHER **Full Name:** University Hospital, Bordeaux ### Status Module #### Completion Date **Date:** 2026-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-03-27 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Bordeaux #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Glioblastomas are the most frequent and aggressive malignant tumors of the CNS in adults, with almost systematic relapse despite treatment with surgery followed by radio-chemotherapy (STUPP protocol). The aim of this study is to better characterize transcriptomic, proteomic and metabolic changes in relapsed glioblastoma compared to the initial tumor, in order to identify new prognostic markers and potential new therapeutic targets. **Detailed Description:** Glioblastomas are the most frequent and aggressive malignant Central Nervous System (CNS) tumors in adults, with a median survival of only 14 months. Current treatment is based on surgery followed by radiochemotherapy (STUPP protocol), unchanged since 2005. Clinical trials evaluating immune checkpoint inhibitors and targeted therapies have largely failed to demonstrate efficacy in these tumors. In order to better understand the oncogenesis of glioblastoma and identify potential new therapeutic targets, the study of the characteristics of relapsed tumors compared with the initial tumor seems relevant. The aim of this retrospective study is to investigate the transcriptomic, proteomic and metabolic characteristics of relapsed glioblastomas reoperated at the University Hospital of Bordeaux, France, between 2005 and 2023, for which tumor material is available. These analyses will be correlated with relapse-free and overall survival of the patients. ### Conditions Module **Conditions:** - Relapsed Cancer - Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype **Keywords:** - Recurrent glioblastoma - Prognostic - Metabolism - Proteomic - Transcriptomic - Microbiota ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients operated for both primary and recurrent glioblastoma between 2005 and 2023 at the CHU de Bordeaux **Intervention Names:** - Biological: Relapsed glioblastoma **Label:** Patients operated for primary and recurrent glioblastoma ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients operated for primary and recurrent glioblastoma **Description:** Paired tumor samples diagnosis/relapse **Name:** Relapsed glioblastoma **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Relative abondance of metabolite and differential enzyme expression in a recurrence versus primary sample **Measure:** Evaluation of metabolic changes involved in glioblastoma relapse **Time Frame:** Up to 2 years after the start of the study #### Secondary Outcomes **Description:** Progression-free survival of patients who underwent surgery for relapse glioblastoma after the surgery of relapse measured at time of inclusion **Measure:** Progression-free survival **Time Frame:** From date of the second surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years **Description:** Overall survival of patients who underwent surgery for relapse glioblastoma after the surgery of relapse **Measure:** Overall survival **Time Frame:** From date of the second surgery until the date of death from any cause, assessed up to 5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * age \> 18 years * surgery for both primary and recurrent glioblastoma between 2005 and 2023 at the CHU de Bordeaux Exclusion Criteria: * systemic therapy received for non-glioblastoma tumor **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with relapsed glioblastomas reoperated at the University Hospital of Bordeaux, France, between 2005 and 2023, for which tumor material is available ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Mathieu LARROQUETTE **Phone:** +33 5 56 79 58 08 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Julien ENGELHARDT **Role:** CONTACT #### Locations **Location 1:** **City:** Bordeaux **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Mathieu LARROQUETTE - **Role:** CONTACT **Country:** France **Facility:** CHU de Bordeaux - Hôpital Saint-André, Service d'Oncologie Médicale **Zip:** 33000 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001254 - Term: Astrocytoma - ID: D000005910 - Term: Glioma - ID: D000018302 - Term: Neoplasms, Neuroepithelial - ID: D000017599 - Term: Neuroectodermal Tumors - ID: D000009373 - Term: Neoplasms, Germ Cell and Embryonal - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009380 - Term: Neoplasms, Nerve Tissue ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M9019 - Name: Glioblastoma - Relevance: HIGH - As Found: Glioblastoma - ID: M4561 - Name: Astrocytoma - Relevance: LOW - As Found: Unknown - ID: M9020 - Name: Glioma - Relevance: LOW - As Found: Unknown - ID: M20446 - Name: Neoplasms, Neuroepithelial - Relevance: LOW - As Found: Unknown - ID: M19845 - Name: Neuroectodermal Tumors - Relevance: LOW - As Found: Unknown - ID: M20388 - Name: Neuroectodermal Tumors, Primitive - Relevance: LOW - As Found: Unknown - ID: M12318 - Name: Neoplasms, Germ Cell and Embryonal - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12325 - Name: Neoplasms, Nerve Tissue - Relevance: LOW - As Found: Unknown - ID: T2518 - Name: Glioblastoma - Relevance: HIGH - As Found: Glioblastoma - ID: T2519 - Name: Glioma - Relevance: LOW - As Found: Unknown - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005909 - Term: Glioblastoma ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430411 **Acronym:** OLIGOMET **Brief Title:** Outcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: OLIGOMET Study **Official Title:** Outcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: OLIGOMET Study #### Organization Study ID Info **ID:** 1336/2022 #### Organization **Class:** OTHER **Full Name:** Medical University of Vienna ### Status Module #### Completion Date **Date:** 2031-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2031-01-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-31 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-04-02 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** IRCCS Ospedale San Raffaele **Class:** OTHER **Name:** University Hospital of Cologne **Class:** OTHER **Name:** St. Antonius Hospital **Class:** OTHER **Name:** Istituto Europeo di Oncologia **Class:** OTHER **Name:** University Hospital, Udine, Italy **Class:** OTHER **Name:** Azienda Ospedaliera San Giovanni Battista **Class:** OTHER **Name:** Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice **Class:** OTHER **Name:** Lund University **Class:** OTHER **Name:** Medical University of Warsaw **Class:** OTHER **Name:** Ziekenhuis Netwerk Antwerpen (ZNA) #### Lead Sponsor **Class:** OTHER **Name:** Medical University of Vienna #### Responsible Party **Investigator Affiliation:** Medical University of Vienna **Investigator Full Name:** Dr. Pawel G. Rajwa **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:** PSMA-PET/CT or PSMA-PET/MRI are more accurate imaging modalities compared to CT/BS; in approximately 10-20% of high-risk patients diagnosed using conventional imaging PSMA-PET up-stages the disease. Therefore a substantial proportion of high-risk patients previously considered as non-metastatic are expected to be diagnosed with oligometastatic disease. While standard treatment pathways exist for patients with non-metastatic or oligometastatic disease confirmed using conventional imaging, less is known about the optimal management of patients with oligometastatic prostate cancer on PSMA-PET. Currently, data on the safety, effectiveness and oncologic outcomes of local therapies in oligometastatic patients diagnosed using PSMA-PET have been poorly reported so far. Thus, there is a need for a prospectively maintained database to collect real-world clinical data to produce high-quality research on the optimal management in oligometastatic prostate cancer who underwent PSMA-PET for primary staging and subsequent local therapy. This database will allow centers to retro- and prospectively collect data to facilitate analysis and assessment of the outcomes of oligometastatic patients managed with local therapy. **Detailed Description:** The Emerging Role of PSMA-PET in Prostate Cancer Imaging PSMA-PET, in conjunction with CT or MRI, has significantly enhanced the precision of prostate cancer staging. Traditional imaging modalities, such as CT or BS, often fail to accurately determine the disease's extent. In contrast, PSMA-PET offers a more precise diagnostic alternative, especially in identifying oligometastatic cases among high-risk prostate cancer patients. Remarkably, 10-20% of patients with unfavorable prostate cancer initially classified as non-metastatic through conventional imaging are reclassified as oligometastatic when reassessed with PSMA-PET. This reclassification is pivotal, possibly influencing treatment decisions and prognostic outcomes. The Need for a Focused Study Oligometastatic prostate cancer represents an intermediate stage between localized and systemic disease, reflecting an early phase in metastatic progression. These tumors not only exhibit unique biological characteristics but also constitute a distinct clinical entity, offering possibilities for long-term control or even cure. Numerous studies demonstrated benefits from combining local and metastasis-directed therapies with systemic treatment in oligometastatic prostate cancer patients diagnosed with conventional imaging. However, despite diagnostic advancements and the evolving uptake of PSMA-PET, substantial gaps persist in the understanding of optimal management for oligometastatic prostate cancer identified with next-generation imaging. Due to the diagnostics advancements and dynamically changing treatment landscape with various local, systemic, and metastasis-directed therapies, this topic requires a prospective multicenter registry. To address this, the investigators have initiated this prospective cohort study focusing on the efficacy and safety of local therapies in oligometastatic prostate cancer patients diagnosed with PSMA-PET, performed under the umbrella of EAU Young Academic Urologists (YAU) Prostate Cancer Working Group. Study Design and Objectives This multicenter, prospective observational cohort study aims primarily to evaluate time to castration-resistance, clinical and radiological progression-free survival in patients with oligometastatic prostate cancer identified using PSMA-PET. Secondary objectives include assessing complications of local therapies, pathological, functional, and oncologic outcomes among others. Eligible patients are those diagnosed with primary oligometastatic prostate cancer with PSMA-PET and treated with local therapies such as radical prostatectomy or radiation. The oligometastatic state is defined as cM1a and/or cM1b with ≤5 bone metastases and/or M1c with ≤3 lung lesions, with or without cN positivity. Key exclusion criteria include the presence of visceral metastases (other than lungs) or neoadjuvant therapy before initial PSMA-PET assessment. The study aims to answer pivotal questions about oncological, functional, and safety outcomes after local treatment in oligometastatic prostate cancer patients on PSMA-PET. Furthermore, the goal is to report treatment strategies for this disease state in this dynamically changing field, and to identify factors predicting improved outcomes. Data Collection and Management Data will be meticulously collected and managed using the Castor electronic case report form platform, provided by the European Association of Urology Foundation for Urological Research, ensuring pseudonymization and security. With the study starting in 2024, the investigators aim to collect data until end of 2030. Estimated Impact of the Study This study is anticipated to substantially contribute to the understanding of oligometastatic prostate cancer and the role of PSMA-PET in its diagnosis and management. In a recent multicenter EAU-YAU study closely related to OLIGOMET project, the investigators have shown that patients with oligometastatic prostate cancer diagnosed with PSMA-PET and treated with radical prostatectomy have overall favorable oncologic outcomes. Nevertheless, a portion of these patients still faced a risk of early progression, emphasizing the need for multimodal therapy. The study illustrated the lack of evidence and precise clinical guidance in this distinct disease stage; there existed significant heterogeneity in the treatment approach among participating tertiary referral centers, with the majority of patients receiving multimodal therapy. While the combination of radiation and systemic therapy can be considered the current standard of care in oligometastatic patients on conventional imaging, the preferred management of patients with a small metastatic burden on PSMA-PET remains unknown. Therefore, the investigators believe that evaluating the effectiveness of local therapies in patients diagnosed with next-generation imaging can pave the way for personalized, and effective treatment strategies of oligometastatic disease in the future. Moreover, the use of PSMA-PET may allow for early identification and intervention, potentially altering the natural history of the disease and improving oncologic control. Finally, the investigators expect that by understanding the role of combination therapies and identifying predictive factors to guide treatment selection, could lead to extended survival and improved quality of life of patients. ### Conditions Module **Conditions:** - Prostate Cancer Metastatic - Prostate Cancer Metastatic to Bone - Prostate Cancer - Prostate Neoplasm - Oligometastatic Disease - Oligometastasis **Keywords:** - prostate - oligometastatic - oligometastasis - oligomet - prostatectomy - irradiation - abiraterone - enzalutamide - darolutamide - apalutamide - androgen deprivation therapy - ADT - docetaxel - PSMA PET ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 5 Years ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Removal of the prostate and seminal vesicles. **Name:** Radical prostatectomy **Type:** PROCEDURE #### Intervention 2 **Description:** Radiation therapy of the prostate. **Name:** Prostate irradiation **Type:** RADIATION #### Intervention 3 **Description:** Surgical removal of metastases. **Name:** Surgical metastasectomy **Type:** PROCEDURE #### Intervention 4 **Description:** Radiation therapy of metastases. **Name:** Irradiation of metastases **Type:** RADIATION #### Intervention 5 **Description:** Administered as part of multimodal treatment for oligometastatic prostate cancer **Name:** Abiraterone acetate **Type:** DRUG #### Intervention 6 **Description:** Administered as part of multimodal treatment for oligometastatic prostate cancer **Name:** Enzalutamide **Type:** DRUG #### Intervention 7 **Description:** Administered as part of multimodal treatment for oligometastatic prostate cancer **Name:** Darolutamide **Type:** DRUG #### Intervention 8 **Description:** Administered as part of multimodal treatment for oligometastatic prostate cancer **Name:** Apalutamide **Type:** DRUG #### Intervention 9 **Description:** Administered as part of multimodal treatment for oligometastatic prostate cancer **Name:** Docetaxel **Type:** DRUG #### Intervention 10 **Description:** Administered as part of multimodal treatment for oligometastatic prostate cancer **Name:** Lutetium-PSMA **Type:** DRUG #### Intervention 11 **Description:** Administered as part of multimodal treatment for oligometastatic prostate cancer **Name:** Androgen deprivation treatment **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Defined as increase in size of existing lesion or appearance of new lesion (on any subsequent follow-up imaging modality used for baseline assessment), or death. **Measure:** Radiographic progression-free survival (rPFS) **Time Frame:** From date of diagnosis until the date of first documented radiographic progression or date of death from any cause, whichever came first, assessed up to 100 months **Description:** Defined as new prostate cancer-related symptom, radiographic progression, initiation of new treatment, or death. **Measure:** Clinical progression-free survival (cPFS) **Time Frame:** From date of diagnosis until the date of first documented clinical progression or date of death from any cause, whichever came first, assessed up to 100 months **Description:** Castration resistance is defined as: castrate serum testosterone \<50ng/dL or 1.7nmol/L, plus either biochemical progression (three consecutive rises in PSA at least one week apart resulting in two 50% increases over the nadir, and a PSA \> 2ng/mL) or radiographic progression (\> 2 new bone lesions or a new soft tissue lesion). **Measure:** Castration resistance-free survival (CRPC-FS) **Time Frame:** From date of diagnosis until the date of castration resistance or date of death from any cause, whichever came first, assessed up to 100 months #### Secondary Outcomes **Description:** Local therapy complications are assessed using Clavien-Dindo classification for radical prostatectomy and RTOG/EORTC Radiation Toxicity Grading for radiation therapy. **Measure:** Local therapy complications **Time Frame:** From the time of local therapy to 30 days after treatment. **Description:** Change of pathological stage **Measure:** Pathological response to systemic therapy **Time Frame:** Measured immediately after the surgery **Description:** Defined as prostate cancer downstaging and/or decrease in number of metastasis lesions due to the effect of systemic therapy. Time Frame: Measured from the administration of systemic treatment until the end of treatment, assessed up to 100 months **Measure:** Imaging response to systemic therapy **Time Frame:** Measured from the administration of systemic treatment until the end of treatment, assessed up to 100 months **Description:** Defined as continence rate (no incontinence 0 pads/24h, mild 1 pads/24h, moderate 2-3 pads/24h, severe \>3 pads/24h). **Measure:** Functional outcomes - continence **Time Frame:** 6 months, 1, 2, and 3 years after local therapy. **Description:** Defined as potency (potent ( IIEF-EF=\>22), inpotent (IIEF-EF \<22) **Measure:** Functional outcomes - potency **Time Frame:** 6 months, 1, 2, and 3 years after local therapy. **Description:** Time from oligometastasis diagnosis to death from prostate cancer. **Measure:** Cancer-specific survival **Time Frame:** From date of diagnosis until the date of death from prostate cancer, assessed up to 100 months **Description:** Time from oligometastasis diagnosis to death of any cause. **Measure:** Overall survival **Time Frame:** From date of diagnosis until the date of death from any cause, assessed up to 100 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Oligometastatic prostate cancer diagnosed using PSMA PET defined as cM1a and/or cM1b with ≤5 osseous metastases and/or M1c with ≤3 lung lesions, with or without cN positivity. * Oligometastatic prostate cancer treated with primary local therapy such as radical prostatectomy or radiation therapy. * Any Gleason Score, any cT stage, any PSA Exclusion Criteria: * Visceral metastases (apart from lungs). * Neoadjuvant therapy prior to first PSMA PET. * Non-metastatic prostate cancer. * Patients who did not undergo imaging before local treatment. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Oligometastatic prostate cancer patients treated with local therapy across Europe. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Tamás Fazekas, MD **Phone:** +36-70-611-8524 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Pawel G Rajwa, MD PhD **Phone:** +48-604-090-416 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Medical University of Vienna **Name:** Shahrokh F Shariat, MD PhD DDsc **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Medical University of Vienna **Name:** Pawel G Rajwa, MD PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005834 - Term: Genital Neoplasms, Male - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000005832 - Term: Genital Diseases, Male - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000011469 - Term: Prostatic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14335 - Name: Prostatic Neoplasms - Relevance: HIGH - As Found: Prostate Cancer - ID: M8946 - Name: Genital Neoplasms, Male - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M8944 - Name: Genital Diseases, Male - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14333 - Name: Prostatic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011471 - Term: Prostatic Neoplasms - ID: D000009369 - Term: Neoplasms ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000050257 - Term: Tubulin Modulators - ID: D000050256 - Term: Antimitotic Agents - ID: D000050258 - Term: Mitosis Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000065088 - Term: Steroid Synthesis Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000006727 - Term: Hormone Antagonists - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000065607 - Term: Cytochrome P-450 Enzyme Inhibitors - ID: D000006728 - Term: Hormones ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1668 - Name: Docetaxel - Relevance: HIGH - As Found: Physical - ID: M4059 - Name: Androgens - Relevance: HIGH - As Found: Geriatric - ID: M451 - Name: Abiraterone Acetate - Relevance: HIGH - As Found: Interleukin- - ID: M26197 - Name: Tubulin Modulators - Relevance: LOW - As Found: Unknown - ID: M26196 - Name: Antimitotic Agents - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - 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: M30537 - Name: Cytochrome P-450 Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077143 - Term: Docetaxel - ID: D000069501 - Term: Abiraterone Acetate - ID: D000000728 - Term: Androgens ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430398 **Acronym:** PREMEM **Brief Title:** A Novel Multiomic AI Approach for Early Preeclampsia Prediction in Pregnancy **Official Title:** Ruolo Del Microbiota Materno Sulla Risposta Immunitaria e Sul Metabolismo Nei Disordini Ipertensivi #### Organization Study ID Info **ID:** 0011882 #### Organization **Class:** OTHER **Full Name:** Istituto Clinico Humanitas ### Status Module #### Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico #### Lead Sponsor **Class:** OTHER **Name:** Istituto Clinico Humanitas #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Preeclampsia (PE) is a leading cause of maternal-fetal morbidity and mortality, affecting 3-8% of pregnancies and causing over 76,000 maternal deaths annually. PE is characterized by high blood pressure and proteinuria or organ damage/intrauterine growth restriction (IUGR). There are two phenotypes: placental PE, caused by abnormal trophoblast invasion, often leading to early pregnancy complications and IUGR, and metabolic PE, associated with maternal metabolic issues like visceral obesity and metabolic syndrome, leading to low-grade inflammation and insulin resistance. Recent research highlights the role of maternal gut microbiota in these conditions, suggesting that gut dysbiosis-altered microbial balance-can influence systemic immune responses and contribute to PE. This study aims to characterize the maternal gut microbiota in the two PE phenotypes to better understand their distinct etiologies and improve prediction and prevention strategies. **Detailed Description:** Preeclampsia (PE) is one of the leading causes of maternal-fetal morbidity and mortality. It is defined as systolic blood pressure (SBP) ≥ 140 and diastolic blood pressure (DBP) ≥ 90 in two consecutive measurements taken 6 hours apart, associated with proteinuria \>300 mg/24 h or 2++ detected by a urine dipstick, or the presence of organ damage or intrauterine growth restriction (IUGR). Preeclampsia complicates 3-8% of pregnancies and is responsible for over 76,000 maternal deaths each year. Scientific evidence suggests the existence of two distinct phenotypes of the condition: placental preeclampsia and metabolic preeclampsia. The first phenotype is caused by abnormal invasion of the maternal endometrium by the trophoblast, leading to preeclampsia often associated with early presentation in pregnancy, intrauterine growth restriction, and the need for delivery at early gestational ages. Fetal growth restriction due to likely placental insufficiency is defined by the Delphi criteria: estimated fetal weight (EFW) \< 3rd percentile, or at least two of the following criteria: EFW \< 10th percentile, a decrease in EFW by at least 40 percentiles even if above the 10th percentile, cerebro-placental ratio (CPR) ≤ 1 (5th percentile) or umbilical artery pulsatility index (PI) ≥ 95th percentile, uterine arteries with PI ≥ 95th percentile. Beyond the hypothesis of abnormal placentation at the beginning of pregnancy, it is now recognized that maternal metabolic risk factors may cause placental malfunction later in pregnancy. The second phenotype is rooted in a metabolic basis, representing about 4% of hypertensive disorders of pregnancy (HDP), and depends on a maternal predisposition in patients with visceral obesity and metabolic syndrome. Visceral obesity is associated with a state of chronic low-grade inflammation, which contributes to insulin resistance, altered glucose homeostasis, and cardiovascular complications. Metabolic preeclampsia occurs in patients with a pre-existing state of low-grade inflammation related to trunk obesity and metabolic syndrome, compounded by the inflammation and insulin resistance typical of pregnancy. Scientific evidence has shown that in the placentas of these patients, there is a higher density of tertiary villi compared to physiological pregnancies, with reduced intervillous spaces, resulting in hypoperfusion and oxidative stress. Differentiation between these clinical phenotypes can be identified during pregnancy by studying fetal growth as an index of placental function, as well as maternal cardiovascular adaptation to pregnancy in terms of hemodynamic parameters and body water, and finally by studying placental histology after delivery. Hypertensive disorders of pregnancy associated with intrauterine growth restriction (HDP-IUGR) and hypertensive disorders of pregnancy with appropriate-for-gestational-age fetuses (HDP-AGA) are distinguished. Currently, starting from the first trimester of pregnancy, maternal cardiovascular and hemodynamic function can be assessed with a non-invasive and harmless method for both mother and fetus using the USCOM (Ultra Sonic Cardiac Output Monitor) system. This provides real-time data on numerous central and peripheral hemodynamic parameters such as cardiac output and stroke volume beat-to-beat. It allows measurement of cardiac output from both the right and left heart, systolic stroke volume (SV), systemic vascular resistance, and inotropic index. Its use in pregnancy has already been validated and will significantly enhance the quality of care provided to women with high-risk or pathological pregnancies. However, there is still discordance among scientific societies regarding the classification of preeclampsia and its potential different clinical phenotypes, making a personalized clinical approach to this condition challenging. While diagnostic criteria have been codified by major national and international scientific societies, it is increasingly important to identify high-risk groups early on, not only to plan a close diagnostic follow-up but also to define appropriate therapeutic strategies based on the etiology. Recently, a screening method at 11-13 weeks of gestation has been developed, capable of predicting 75% of pregnancies that will develop preterm preeclampsia (\<37 weeks of gestation). This is based on a risk calculation algorithm that combines measurements of weight and height, mean arterial pressure measured with automated devices, blood sampling for PLGF levels, and Doppler ultrasound measurement of the mean pulsatility index (PI) of the uterine arteries. However, this screening can only predict a subset of patients who will develop preeclampsia \<37 weeks and who may benefit from aspirin administration if taken at doses \>100mg and before 16 weeks. To date, it is still not possible to effectively predict and prevent preeclampsia manifesting \>37 weeks, and the etiology of this serious obstetric condition remains a topic of debate and scientific research. Among emerging etiological hypotheses, numerous scientific publications support that an alteration in maternal immunity and immune tolerance underlies hypertensive disorders in pregnancy. Studies on animal models have shown that the activation and expansion of aberrant B cells can trigger inflammatory events leading to preeclampsia. IFN-γ produced by NK cells plays an essential role in spiral arterial remodeling in murine pregnancy. Studies on NK cell-deficient mice have shown defective placental vascular remodeling, characterized by narrow vascular lumens, thick vascular walls, and retention of vascular smooth muscle actin. Recent discoveries suggest that changes in the maternal gut microbiota, a commensal microbial community capable of modulating the host's immune responses, underlie these immunological alterations. It has been widely described how changes in the diversity and composition of the host gut microbiota-a phenomenon called "dysbiosis," commonly induced by dietary changes or antibiotic treatment-affect systemic immune responses and can disrupt the balance between pro-inflammatory and anti-inflammatory activation. Gut dysbiosis can be associated with excessive weight gain during pregnancy and promote metabolic disorders such as gestational diabetes and preeclampsia, with risks of metabolic alterations in the newborn. Based on these premises, this study aims to define the characteristics of the maternal gut microbiota in the two different clinical phenotypes of preeclampsia: placental preeclampsia, where the hypertensive disorder is associated with growth restriction, and metabolic preeclampsia, where the hypertensive disorder is associated with a fetus of appropriate weight for gestational age. ### Conditions Module **Conditions:** - Preeclampsia ### Design Module #### Bio Spec **Description:** The protocol involves the analysis of maternal microbiota and metabolome from saliva and fecal samples, as well as blood samples collected from consenting women during scheduled obstetric visits conducted by the study's responsible physicians until delivery. At each visit, as per protocol, saliva and fecal samples will be collected and frozen at -80°C, and a 7 ml whole peripheral blood sample in EDTA will be collected and kept at room temperature. The blood will be centrifuged to separate plasma from the cellular fraction. The isolated plasma will be frozen at -80°C for subsequent metabolomic and microbiota analyses, while the cells will be resuspended in phosphate-buffered saline (PBS) in equal volume to the isolated plasma. **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 600 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Age \> 18 years Singleton pregnancy Live fetus at 11-13 weeks of pregnancy Women identified as high-risk during first-trimester screening for preeclampsia and fetal growth restriction **Label:** Case #### Arm Group 2 **Description:** Low-risk pregnancies at first-trimester screening for preeclampsia and fetal growth restriction, which will undergo physiological monitoring in subsequent follow-up visits until delivery (homogeneous control sample). **Label:** Control ### Outcomes Module #### Primary Outcomes **Description:** Identifying biomarkers useful for predicting different clinical phenotypes of preeclampsia that could assist in innovative preventive strategies and/or future therapeutic targets. **Measure:** Identification of Biomarkers for Predicting Clinical Phenotypes of Preeclampsia: Implications for Innovative Preventive Strategies and Future Therapeutic Targets **Time Frame:** through study completion, an average of 1 year #### Secondary Outcomes **Description:** Evaluation of microbiota changes in patients at high risk during first-trimester screening for preeclampsia or fetal growth restriction **Measure:** Assessment of first trimester microbiota characteristics **Time Frame:** through study completion, an average of 1 year **Description:** Evaluation of metabolites in patients at high risk during first-trimester screening for preeclampsia or fetal growth restriction **Measure:** Assessment of first trimester metaboloma characteristics **Time Frame:** through study completion, an average of 1 year **Description:** Evaluation of maternal immune cells in patients at high risk during first-trimester screening for preeclampsia or fetal growth restriction **Measure:** Assessment of first trimester immune system characteristics **Time Frame:** through study completion, an average of 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age \> 18 years * Singleton pregnancy * Live fetus at 11-13 weeks of gestation * Women identified as high-risk during first-trimester screening for preeclampsia and subsequent low risk * Written Informed Consent Exclusion Criteria: * Multiple pregnancy * Pregnancy complicated by major fetal anomalies identified during the evaluation at 11-13 weeks gestation, * Unconscious or severely ill women, women with learning difficulties, and severe psychiatric disorders, * Age \<18 years * - Women who will not have signed the informed consent for the study Women with HIV, HBV, HCV infection * Women with a history of leukemia and lymphoma * Women with immunodeficiency * Women who have used corticosteroids or other immunosuppressants in the past 3 months **Gender Based:** True **Gender Description:** Pregnancy **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Women identified as high risk for developing preeclampsia from the first trimester of pregnancy will be offered the opportunity to participate in the study. To obtain a control sample, an equal number (1:1 ratio) of pregnant women identified as low risk during the first-trimester screening for preeclampsia and fetal growth restriction, and who will present physiological check-ups in subsequent follow-up visits until delivery, will also be invited to participate. Recruitment of controls will follow an alternating principle: high risk-low risk-high risk-low risk. Patients will be followed up according to a defined schedule, varying depending on the underlying condition, while high-risk patients and controls will be seen once per trimester if the pregnancy remains uncomplicated. ### Contacts Locations Module #### Locations **Location 1:** **City:** Pieve Emanuele **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Silvia Giugliano, PhD - **Phone:** +390282243190 - **Role:** CONTACT ***Contact 2:*** - **Name:** Silvia Giugliano, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Italy **Facility:** Hunanitas University **State:** Milan **Status:** RECRUITING **Zip:** 20072 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000046110 - Term: Hypertension, Pregnancy-Induced - 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: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14106 - Name: Pre-Eclampsia - Relevance: HIGH - As Found: Preeclampsia - ID: M7633 - Name: Eclampsia - Relevance: LOW - As Found: Unknown - ID: M10024 - Name: Hypertension - Relevance: LOW - As Found: Unknown - ID: M25635 - Name: Hypertension, Pregnancy-Induced - 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: T2019 - Name: Eclampsia - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011225 - Term: Pre-Eclampsia ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430385 **Brief Title:** ATTUNE: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intrathecally-Administered ION440 in Participants With Methyl CpG Binding Protein 2 (MECP2) Duplication Syndrome (MDS) **Official Title:** A Phase 1-2, Double-Blind, Sham-Controlled Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intrathecally-Administered ION440 in Patients With MECP2 Duplication Syndrome #### Organization Study ID Info **ID:** ION440-CS1 #### Organization **Class:** INDUSTRY **Full Name:** Ionis Pharmaceuticals, Inc. #### Secondary ID Infos **ID:** 2023-507192-22 **Type:** EUDRACT_NUMBER ### Status Module #### Completion Date **Date:** 2030-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-08 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Ionis Pharmaceuticals, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The primary purpose of this study is to evaluate the safety and tolerability of ION440. **Detailed Description:** This is a phase 1-2 randomized, double-blind, sham-controlled, multiple-ascending dose (MAD) study to evaluate ION440 in pediatric and adult participants with MECP2 Duplication Syndrome (MDS) and will be conducted in two parts. During Part 1 (MAD) (36 weeks), participants will be randomized in a 3:1 ratio to receive ION440 or sham. Individuals who complete Part 1 may enter Part 2, an open label long-term extension study (LTE), where they will receive ION440 for up to approximately 156 weeks. Multiple dose cohorts (Dose A, Dose B, and Dose C) will be evaluated in the study. All dosing cohorts will be further subdivided by age. Sub cohort A will include participants 8 years of age and older and sub cohort B will include participants 2 through 7 years of age. Dosing cohorts will be enrolled sequentially with sub cohort A initiating prior to sub cohort B. ### Conditions Module **Conditions:** - Methyl CpG Binding Protein 2 (MECP2) Duplication Syndrome ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 48 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive ION440 intrathecally at Dose A during Part 1/MAD, followed by ION440 Dose A during Part 2/LTE. **Intervention Names:** - Drug: ION440 **Label:** Cohort 1: ION440 Dose A **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive ION440 intrathecally at Dose B during Part 1/MAD, followed by ION440 Dose B during Part 2/LTE. **Intervention Names:** - Drug: ION440 **Label:** Cohort 2: ION440 Dose B **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Participants will receive ION440 intrathecally at Dose C during Part 1/MAD, followed by ION440 Dose C during Part 2/LTE. **Intervention Names:** - Drug: ION440 **Label:** Cohort 3: ION440 Dose C **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** During the Part 1/MAD period, a lumbar procedure (LP) will be performed at the same frequency as ION440 administration. Participants will not receive ITB injections during this period. It will be followed by the open-label Part 2/LTE period, where participants will receive ION440 at the same dose as their enrolled cohort (e.g. Dose A, Dose B or Dose C). **Intervention Names:** - Procedure: Sham procedure **Label:** Sham Procedure **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Cohort 1: ION440 Dose A - Cohort 2: ION440 Dose B - Cohort 3: ION440 Dose C **Description:** ION440 will be administered by intrathecal bolus (ITB) injection. **Name:** ION440 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Sham Procedure **Description:** An LP will be performed with CSF collection but will not be followed by the administration of study treatment by ITB injection. **Name:** Sham procedure **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Measure:** Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) **Time Frame:** Up to approximately 36 weeks **Measure:** Part 1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs **Time Frame:** Baseline up to approximately 36 weeks **Measure:** Part 1: Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings **Time Frame:** Baseline up to approximately 36 weeks **Measure:** Part 1: Number of Participants With Clinically Significant Change from Baseline in Laboratory Assessments **Time Frame:** Baseline up to approximately 36 weeks **Measure:** Part 1: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) **Time Frame:** Baseline up to approximately 36 weeks **Measure:** Part 2: Number of Participants With TEAEs **Time Frame:** Up to approximately 192 weeks **Measure:** Part 2: Number of Participants With Clinically Significant Change From Baseline in Vital Signs **Time Frame:** Baseline up to approximately 192 weeks **Measure:** Part 2: Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings **Time Frame:** Baseline up to approximately 192 weeks **Measure:** Part 2: Number of Participants With Clinically Significant Change from Baseline in Laboratory Assessments **Time Frame:** Baseline up to approximately 192 weeks **Measure:** Part 2: Number of Participants With Clinically Significant Change From Baseline in ECG **Time Frame:** Baseline up to approximately 192 weeks #### Secondary Outcomes **Measure:** Part 1: Maximum Observed Concentration (Cmax) of ION440 in Plasma **Time Frame:** Pre-dose and at multiple points post-dose up to Week 36 **Measure:** Part 1: Area Under the Concentration-time Curve (AUC) of ION440 in Plasma **Time Frame:** Pre-dose and at multiple points post-dose up to Week 36 **Measure:** Part 1: Plasma Terminal Elimination Half-life (t½) of ION440 **Time Frame:** Pre-dose and at multiple points post-dose up to Week 36 **Measure:** Part 1: Trough Concentration (Ctrough) of ION440 in Plasma and CSF **Time Frame:** Pre-dose and at multiple points post-dose up to Week 36 **Measure:** Part 1: Plasma Concentration of ION440 **Time Frame:** Pre-dose and at multiple points post-dose up to Week 36 **Measure:** Part 2: Trough Concentration (Ctrough) of ION440 in Plasma and CSF **Time Frame:** Up to approximately 192 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion criteria for Part 1: 1. Males age ≥ 2 years to ≤ 65 years old, depending on specific cohort and group, at the time of informed consent. 1. Group A: ≥ 8 to ≤ 65 years old 2. Group B: 2 to 7 years old, inclusive 2. Participant has at least one parent or caregiver ≥ 18 years old capable of providing informed consent (signed and dated), and able to attend all scheduled study visits and provide feedback regarding the participant's symptoms and performance as described in the protocol, and able to comply with all study requirements and activities, 3. Participant has a documented diagnosis of MDS, with genetic confirmation of MECP2 duplication 4. Is currently receiving stable doses of concomitant medications for at least 3 months prior to baseline. If recent changes (\< 3 months stable) in medications, the participant may be allowed per Investigator judgment in consult with Sponsor Medical Monitor. 5. Able to complete all study procedures, measurements and visits and caregiver/participant has adequately supportive psychosocial circumstances, in the opinion of the Investigator. Exclusion criteria for Part 1: 1. Documented diagnosis of complex MECP2 duplications including terminal duplication and/or translocation or MECP2 triplication OR clinical features associated with complex variant structure including (a) onset of seizures prior to age 5 (for those age 5 and above at signing of ICF), (b) oxygen dependence, (c) microcephaly, IF MECP2 genetic structure information is unavailable. 2. Clinically significant vital sign or ECG abnormality at Screening \[including heart rate (HR) \< 45 beats per minute; systolic blood pressure \< 90 millimeters of mercury (mmHg); confirmed blood pressure readings \> 170/105 mmHg\] 3. Known brain or spinal disease that would interfere with the LP procedure, or CSF circulation or presence of other factors would affect the safety of the LP procedure. 4. Has any concomitant disease or condition or circumstance, or any finding at Screening that, in the opinion of the Investigator, makes the participant unsuitable for enrollment or that could interfere with the conduct of the study or that would pose an unacceptable risk to the participant in this study. 5. Treatment with an investigational drug, biological agent, or device within 30 days of Screening, or 5 half-lives of investigational agent, whichever is longer. 6. Previous treatment with an oligonucleotide (including siRNA) within 4 months of Screening if single dose received, or within 12 months of Screening if multiple doses received (this exclusion does not apply to vaccines - both mRNA and viral vector vaccines are allowed including COVID-19). For centrally administered ASOs, a minimum of 12 months washout is required irrespective of the number of doses received. 7. Currently enrolled in a clinical trial of an investigational agent or device or has used any investigational agent or device within 5 half-lives of investigational agent, whichever is longer. 8. Has a history of gene therapy or cell transplantation or any other experimental brain surgery. 9. Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Baseline (Day 1). 10. Has experienced Status Epilepticus in the past 6 months. Inclusion criteria for Part 2: 1. Completed ION440-CS1, Part 1/MAD. Completers are defined as participants who received at least one dose of Study Drug and attended all study visits through Follow Up. 2. All inclusion criteria in Part 1/MAD apply (participants will not be required to undergo new Screening bloodwork). Exclusion criteria for Part 2: 1. Has developed any concomitant disease (e.g., gastrointestinal, renal, hepatic, endocrine, respiratory, or cardiovascular system disease) or condition or circumstance, or any finding during Part 1/MAD that, in the opinion of the Investigator, makes the participant unsuitable for continued treatment (e.g. could interfere with the conduct of the study or that would pose an unacceptable risk to the participant in this study). **Gender Based:** True **Gender Description:** Only males are included for this disease condition. **Maximum Age:** 65 Years **Minimum Age:** 2 Years **Sex:** MALE **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ionis Pharmaceuticals **Phone:** (844) 779-1497 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000038901 - Term: Mental Retardation, X-Linked - ID: D000008607 - Term: Intellectual Disability - ID: D000019954 - Term: Neurobehavioral Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000040181 - Term: Genetic Diseases, X-Linked - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000020271 - Term: Heredodegenerative Disorders, Nervous System ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M18163 - Name: Rett Syndrome - Relevance: HIGH - As Found: Methyl CpG Binding Protein 2 - ID: M11589 - Name: Intellectual Disability - Relevance: LOW - As Found: Unknown - ID: M24774 - Name: Mental Retardation, X-Linked - 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: M24877 - Name: Genetic Diseases, X-Linked - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M22092 - Name: Heredodegenerative Disorders, Nervous System - Relevance: LOW - As Found: Unknown - ID: T4987 - Name: Rett Syndrome - Relevance: HIGH - As Found: Methyl CpG Binding Protein 2 - ID: T3658 - Name: MECP2 Duplication Syndrome - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015518 - Term: Rett Syndrome - ID: D000013577 - Term: Syndrome ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430372 **Brief Title:** Study of VEGF-A Targeting NIR-II Fluorescence Endoscopy in the Gastrointestinal Tract **Official Title:** Study of Vascular Endothelial Growth Factor A Targeting NIR-II Fluorescence in the Endoscopy of Gastrointestinal Tract #### Organization Study ID Info **ID:** NIR-II-ENDO #### Organization **Class:** OTHER **Full Name:** Institute of Automation, Chinese Academy of Sciences ### Status Module #### Completion Date **Date:** 2026-05-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Institute of Automation, Chinese Academy of Sciences #### Responsible Party **Investigator Affiliation:** Institute of Automation, Chinese Academy of Sciences **Investigator Full Name:** Zhenhua Hu **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 study, the investigators are studying new ways to look for abnormal tissues of the gastrointestinal tract during an endoscopy. We are using a VEGF-A targeting fluorescent probe and a NIR-II fluorescent endoscope to help detect abnormal tissues that are hard to see by the naked eye. The main purposes of this study include: 1. To translate the NIR-II approach into the endoscopy, and understand its advantages and limitations on detecting abnormal tissues in gastrointestinal. 2. To validate whether topical administration of a targeting probe can stick to abnormal tissues and be detected by the NIR-II endoscope. 3. To validate the safety and effectiveness of the topical administration of VEGF-A targeting probes for clinical application. ### Conditions Module **Conditions:** - Gastrointestinal Carcinoma - Dysplasia - Gastrointestinal Polyp ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** SCREENING #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The patients will receive a topical administration of probe (Bev-ICG) during the endoscopy. Then fluorescence imaging will be performed to guide the detection. **Intervention Names:** - Drug: Bev-ICG - Device: NIR-II fluorescence endoscopy platform **Label:** Bev-ICG NIR-II Endoscopy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Bev-ICG NIR-II Endoscopy **Description:** Probe targeting VEGF-A that is topically administrated during the endoscopy **Name:** Bev-ICG **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Bev-ICG NIR-II Endoscopy **Description:** An endoscopic detection device which can detect and visualize NIR-II fluorescent signal during the endoscopy **Name:** NIR-II fluorescence endoscopy platform **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Demonstrate the feasibility of using the NIR-II endoscope and VEGF-A targeting fluorescent probe to image abnormal tissues of the gastrointestinal tract. **Measure:** Validation of NIR-II endoscope and probe targeting VEGF-A **Time Frame:** During endoscopy ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Known or suspected gastrointestinal lesions. * Scheduled for a clinically-indicated endoscopy. * Mentally competent person, 18 years or older. * Approved to sign the informed consent. * Adequate potential for follow-up. Exclusion Criteria: * Subjects with known allergy or negative reaction to ICG or derivatives. * Undesirable function of heart, lung, kidney, or any other organs. * Enrolled in other trials in the past 3 months. * Pregnant or trying to conceive. * Unable to tolerate an endoscopy. * Medical or psychiatric conditions that compromise the patient's ability to give informed consent. * The researchers considered inappropriate to be included. **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:** Lidan Fu **Phone:** 17754927702 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Lidan Fu - **Phone:** 17754927702 - **Role:** CONTACT **Country:** China **Facility:** Lidan Fu **State:** Beijing **Status:** RECRUITING **Zip:** 100190 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M14011 - Name: Polyps - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M18681 - Name: Endothelial Growth Factors - 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:** NCT06430359 **Acronym:** VARCUWIC **Brief Title:** Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients **Official Title:** Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients Treated With Chelators or Zinc Salts #### Organization Study ID Info **ID:** 69HCL23_1227 #### Organization **Class:** OTHER **Full Name:** Hospices Civils de Lyon ### Status Module #### Completion Date **Date:** 2025-08-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-08-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hospices Civils de Lyon #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Wilson's disease (WD) is a genetic disorder characterized by an accumulation of copper in the body, mainly in the liver and brain. Patients suffering from this disease are monitored by liver function tests, blood copper levels, and 24-hour urinary copper determinations. Treatment is based either on chelating the copper accumulated in the body using D-penicillamine or Trientine or on limiting intestinal copper absorption with zinc salts. Monitoring copper elimination in urine collected over 24 hours is essential for estimating a patient's copper load, adapting treatment dosage, and detecting any copper deficiency. Nevertheless, urine collection is often complicated for patients, given the obvious constraints of collecting urine over 24 hours. Without this, clinical decisions are usually made based on spot urine. There is no official recommendation for monitoring urinary copper elimination other than on 24-hour urine. According to studies on healthy volunteers under physiological conditions, urinary copper elimination occurs according to a circadian rhythm, with minimal copper elimination between 8 pm and 4 am and maximum between 8 am and noon. The study would aim to find the period of the day best correlated with 24h urinary copper excretion ### Conditions Module **Conditions:** - Wilson Disease **Keywords:** - Wilson disease - urinary copper - chelator ### Design Module #### Bio Spec **Description:** 3 urine collections of an 8h period. One blood sample for liver function test and copper assessment **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4 ). Aged between 6 years and 70 years. Treated with D-Pencillamine **Intervention Names:** - Diagnostic Test: urine and blood test **Label:** Group 1 - DP #### Arm Group 2 **Description:** Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4 ). Aged between 6 years and 70 years. Treated with Trientine **Intervention Names:** - Diagnostic Test: urine and blood test **Label:** Group 2 - Trientine #### Arm Group 3 **Description:** Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4 ). Aged between 6 years and 70 years. Treated with Zinc. **Intervention Names:** - Diagnostic Test: urine and blood test **Label:** Group 3 - ZINC ### Interventions #### Intervention 1 **Arm Group Labels:** - Group 1 - DP - Group 2 - Trientine - Group 3 - ZINC **Description:** 3 urine collections of an 8h period. One blood sample for liver function test and copper assessment **Name:** urine and blood test **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Correlation between 24-hour urinary copper excretion and 8-hour urinary copper excretion collected between midnight and 8 am). **Measure:** Correlation factor **Time Frame:** Two 24-hour urine recollection ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4). * Age ≥ 6 years and ≤70 years. * Patient able to perform 24h urine. * Current treatment with D-Pencillamine, Trientine or Zinc. * Non-opposition of patient and/or legal representatives for minor patients. Exclusion Criteria: * Patients who had a change in treatment within the last 6 months before the inclusion * Patients who have undergone liver transplantation * Patients with known chronic renal failure (GFR \< 30 ml/min) * Patients on long-term diuretic or corticosteroid therapy * Persons deprived of liberty by a judicial or administrative decision * Patient under judicial protection, unable to express consent **Maximum Age:** 70 Years **Minimum Age:** 6 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** - Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4). ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Eduardo COUCHONNAL, Dr **Phone:** 04 27 35 70 50 **Phone Ext:** +33 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Abdelouahed BELMALIH, PhD **Phone:** 04 27 85 62 67 **Phone Ext:** +33 **Role:** CONTACT #### Locations **Location 1:** **City:** Bron **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Eduardo Couchonnal, Dr - **Phone:** 04 27 35 70 50 - **Phone Ext:** +33 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Abdelouahed BELMALIH, PhD - **Phone:** 04 27 85 62 67 - **Phone Ext:** +33 - **Role:** CONTACT **Country:** France **Facility:** Service de Gastroentérologie, Hépatologie et Nutrition Pédiatriques - Hôpital Femme Mère Enfant **State:** Rhone **Zip:** 69500 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008107 - Term: Liver Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000001480 - Term: Basal Ganglia Diseases - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000020739 - Term: Brain Diseases, Metabolic, Inborn - ID: D000001928 - Term: Brain Diseases, Metabolic - ID: D000009069 - Term: Movement Disorders - ID: D000020271 - Term: Heredodegenerative Disorders, Nervous System - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000008661 - Term: Metabolism, Inborn Errors - ID: D000008664 - Term: Metal Metabolism, Inborn Errors - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9612 - Name: Hepatolenticular Degeneration - Relevance: HIGH - As Found: Wilson Disease - ID: M11107 - Name: Liver 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: M25603 - Name: Ganglion Cysts - Relevance: LOW - As Found: Unknown - ID: M16358 - Name: Synovial Cyst - Relevance: LOW - As Found: Unknown - ID: M4774 - Name: Basal Ganglia Diseases - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M5205 - Name: Brain Diseases, Metabolic - Relevance: LOW - As Found: Unknown - ID: M22498 - Name: Brain Diseases, Metabolic, Inborn - Relevance: LOW - As Found: Unknown - ID: M12029 - Name: Movement Disorders - Relevance: LOW - As Found: Unknown - ID: M22092 - Name: Heredodegenerative Disorders, Nervous System - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M11641 - Name: Metabolism, Inborn Errors - Relevance: LOW - As Found: Unknown - ID: M11644 - Name: Metal Metabolism, Inborn Errors - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: T5933 - Name: Wilson Disease - Relevance: HIGH - As Found: Wilson Disease ### Condition Browse Module - Meshes - ID: D000006527 - Term: Hepatolenticular Degeneration ### Intervention Browse Module - Browse Branches - Abbrev: Hemat - Name: Hematinics - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Micro - Name: Micronutrients - Abbrev: Mi - Name: Mineral ### Intervention Browse Module - Browse Leaves - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown - ID: M5860 - Name: Chelating Agents - Relevance: LOW - As Found: Unknown - ID: M17768 - Name: Zinc - Relevance: LOW - As Found: Unknown - ID: M6523 - Name: Copper - Relevance: LOW - As Found: Unknown - ID: M17018 - Name: Trientine - Relevance: LOW - As Found: Unknown - ID: T338 - Name: Copper Supplement - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430346 **Brief Title:** Exercise Prehabilitation for Locoregional Esophageal Cancer **Official Title:** Exercise Prehabilitation for Locoregional Esophageal Cancer: A Pilot Study #### Organization Study ID Info **ID:** MCC-23121 #### Organization **Class:** OTHER **Full Name:** H. Lee Moffitt Cancer Center and Research Institute ### Status Module #### Completion Date **Date:** 2027-05 **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:** 2027-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-21 **Type:** ACTUAL **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** H. Lee Moffitt Cancer Center and Research Institute #### 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 purpose of the study is to examine the feasibility and acceptability of exercise "prehabilitation" for patients preparing for esophageal cancer resection (removal). ### Conditions Module **Conditions:** - Esophageal Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In this trial participants will participate in an exercise program for 5 to 17 weeks, varying with treatment plans. Participants will receive resistance training equipment and participate in resistance training sessions twice per week (approximately 30-45 minutes per session). A Fitbit device will be provided to monitor step counts. **Intervention Names:** - Behavioral: Exercise **Label:** Exercise prehabilitation **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Exercise prehabilitation **Description:** Physical activity and resistance training **Name:** Exercise **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The number of participants who complete T0 and T1 measures. **Measure:** Retention **Time Frame:** Up to 11 weeks #### Secondary Outcomes **Description:** The number of participants who demonstrate improvements in exploratory outcome measures. **Measure:** Exploratory outcomes and changes **Time Frame:** Up to 17 weeks **Description:** Chi-square testing will be used to determine if there's a difference in perioperative outcomes between groups. **Measure:** Clinical and treatment outcomes **Time Frame:** Up to 17 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Biopsy-proven locoregional esophageal cancer (LEC) * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Treatment plan including neoadjuvant chemoradiation therapy and surgical resection * Ability to read and speak English Exclusion Criteria: * Regular engagement in resistance training (2x/week targeting all major muscle groups) * Screen failure for exercise safety based on PAR-Q * Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease * Recent fracture or acute musculoskeletal injury that precludes ability to participate in resistance training safely * Numeric pain rating scale of 7 or more out of 10 * Myopathic or rheumatologic disease that impacts physical function **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Nathan Parker, PhD **Phone:** 813-745-6849 **Role:** CONTACT #### Locations **Location 1:** **City:** Tampa **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Nathan Parker, PhD - **Phone:** 813-745-0527 - **Role:** CONTACT ***Contact 2:*** - **Name:** Nathan Parker, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Jose Pimiento, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Moffitt Cancer Center **State:** Florida **Status:** RECRUITING **Zip:** 33612 #### Overall Officials **Official 1:** **Affiliation:** Moffitt Cancer Center **Name:** Nathan Parker, PhD **Role:** PRINCIPAL_INVESTIGATOR ## 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: 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: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M8088 - Name: Esophageal Neoplasms - Relevance: HIGH - As Found: Esophageal Cancer - 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: HIGH - As Found: Esophageal Cancer ### Condition Browse Module - Meshes - ID: D000004938 - Term: Esophageal Neoplasms ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430333 **Acronym:** STRIDE P **Brief Title:** Sleep to Reduce Incident Depression Effectively in Peripartum **Official Title:** Sleep to Reduce Incident Depression Effectively in Peripartum #### Organization Study ID Info **ID:** STRIDE P #### Organization **Class:** OTHER **Full Name:** Henry Ford Health System ### Status Module #### Completion Date **Date:** 2028-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2025-10-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Henry Ford Health System #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Perinatal depression (PND) is the most common complication in pregnancy and postpartum, which increases risk for adverse perinatal outcomes such as preterm birth, maternal suicidal thoughts, and impaired mother-infant bonding. Insomnia often precedes PND cases and may serve as an entry point for interventions preventing PND. The proposed project is a large-scale clinical trial to test the effectiveness of a mindfulness-based sleep program designed for pregnant women to improve sleep and alleviate cognitive arousal to reduce risk for PND across pregnancy and postpartum. **Detailed Description:** Perinatal depression (PND) affects nearly 20% of pregnant and postpartum women, with estimates soaring above 30% during the COVID-19 pandemic. Prospective data show insomnia often precedes PND incidence and relapse cases by more than doubling risk for major depression. This is highly relevant to a large segment of the pregnant population as \~20% of women meet diagnostic criteria for insomnia disorder by the end of pregnancy. Fortunately, insomnia is a modifiable risk factor for PND, and insomnia may serve as an entry point to prevent PND incidence and relapse. Our team has identified cognitive arousal as a promising candidate factor for alleviating insomnia and preventing depression via insomnia therapy. Indeed, undertreatment of cognitive arousal in pregnancy is associated with insomnia non-remission and continued depression after therapy. Moreover, patient stakeholders identify 'calming a busy mind at night' as a critical target for improving sleep during pregnancy. In effort to enhance alleviation of cognitive arousal to optimize clinical outcomes, we developed Perinatal Understanding of Mindful Awareness for Sleep (PUMAS). PUMAS places behavioral sleep strategies within a mindfulness intervention framework to develop an insomnia therapy specifically for pregnant women: RCT data show that PUMAS yields large effects on insomnia, depression, and cognitive arousal. This study is a hybrid effectiveness-implementation RCT of 500 women with DSM-5 insomnia disorder (without PND) who are randomized to PUMAS or treatment-as-usual. We will evaluate the effectiveness of PUMAS for alleviating insomnia and preventing PND across pregnancy and the first postpartum year. We will also investigate whether PUMAS engages a key candidate mechanism (high cognitive arousal) that is operative for addressing these clinical outcomes in the effectiveness context. ### Conditions Module **Conditions:** - Insomnia - Depression **Keywords:** - pregnancy - postpartum - sleep - worry - rumination ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** PUMAS is a clinician-administered psychotherapy intervention for prenatal insomnia that includes six weekly 60-minute sessions in an individual format. PUMAS combines behavioral sleep strategies with mindfulness exercises and tailors all components to pregnancy to improve sleep quality. PUMAS will be delivered via telemedicine video. **Intervention Names:** - Behavioral: Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) **Label:** Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** TAU reflects real-world care where patients and their providers make their own treatment decisions for treating prenatal insomnia. Common TAU options include over-the-counter sleep aids, sleep hygiene education, melatonin, and cognitive-behavioral therapy for insomnia. The TAU group will be well-characterized (i.e., we will monitor interventions administered by the usual care providers and collect information on dosage, frequency, duration, adherence) to best describe treatment options sought and completed in the real world. **Intervention Names:** - Other: Treatment-as-usual (TAU) **Label:** Treatment-as-usual (TAU) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) **Description:** Mindfulness-based sleep program for pregnant women. **Name:** Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Treatment-as-usual (TAU) **Description:** Usual practices from real-world care experiences. **Name:** Treatment-as-usual (TAU) **Other Names:** - Usual care practice **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The Insomnia Severity Index is a commonly used self-report measure of insomnia symptoms that has been validated in peripartum. ISI scores range from 0 to 28 with higher scores indicating greater insomnia severity. **Measure:** Insomnia effectiveness **Time Frame:** We will examine change in ISI from Pretreatment Baseline to Posttreatment (8 weeks after baseline), and monthly across the first postpartum year. **Description:** The Edinburgh Postnatal Depression Scale (EDPS) is the most widely use depression measure in pregnancy and postpartum. EPDS scores range from 0 to 30 with higher scores indicating greater depression severity. **Measure:** Depression prevention **Time Frame:** We will examine onset of major depression (EPDS scores 13 or higher) at posttreatment (8 weeks after baseline) and assessed monthly across the first postpartum year. #### Secondary Outcomes **Description:** The Pre-Sleep Arousal Scale's Cognitive factor (PSASC) is a self-report measure of nocturnal cognitive arousal that has been validated in peripartum. PSASC scores range 8 to 40 with higHEr scores indicating greater pre-sleep cognitive arousal. **Measure:** Pre-sleep cognitive arousal **Time Frame:** We will examine change in PSASC from pretreatment to posttreatment (8 weeks later). ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Singleton pregnancy, gestational week 14-31 at screening. 2. DSM-5 Insomnia Disorder (≥1 month duration). 3. Insomnia Severity Index (ISI) score ≥ 11. 4. Edinburgh Postnatal Depression Scale score\<13 at screening. 5. No current DSM-5 Major Depression. 6. Reliable internet access for treatment and assessments. 7. Not currently engaged in therapy for major depression or insomnia disorder. Exclusion Criteria: 1. High risk pregnancy (pre-eclampsia, placenta previa w/ hemorrhage, other conditions deemed serious risk to mother or fetus; hypertension and diabetes are allowed). 2. Active suicidal intent. 3. Night or rotating shift work, anticipated travel across time 3 or more time zones in the 2 months after baseline screening. 4. Untreated RLS (treated RLS is OK). 5. Excessive daytime sleepiness; Epworth Sleepiness Scale\>15. 6. Uncontrolled sleep or mental disorder inappropriate or unsafe for sleep restriction (narcolepsy, bipolar, epilepsy, etc.). **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** David A Kalmbach, PhD **Phone:** 248-325-3938 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Christopher L Drake, PhD **Phone:** 248-344-6672 **Role:** CONTACT #### Locations **Location 1:** **City:** Novi **Country:** United States **Facility:** Henry Ford Medical Center **State:** Michigan **Zip:** 48377 #### Overall Officials **Official 1:** **Affiliation:** Henry Ford Health **Name:** David A Kalmbach, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** N/A - We do not plan to share individual participant data to other researchers. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms - 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 - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depression - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M2062 - Name: Rumination Syndrome - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: T5077 - Name: Rumination Disorder - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003863 - Term: Depression - ID: D000003866 - Term: Depressive Disorder ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AAll - Name: Anti-Allergic Agents - Abbrev: AnEm - Name: Antiemetics - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M11533 - Name: Melatonin - Relevance: LOW - As Found: Unknown - ID: M7338 - Name: Diphenhydramine - Relevance: LOW - As Found: Unknown - ID: M14268 - Name: Promethazine - Relevance: LOW - As Found: Unknown - ID: T410 - Name: Melatonin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430320 **Acronym:** ALOFT **Brief Title:** Ascertaining Longterm Outcomes of Fibroid Treatments **Official Title:** Long Term Effectiveness of Uterine Sparing Fibroid Treatments #### Organization Study ID Info **ID:** R9NXPE2GTCN9 #### Organization **Class:** OTHER **Full Name:** Henry Ford Health System ### Status Module #### Completion Date **Date:** 2027-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2025-02 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Mayo Clinic **Class:** OTHER **Name:** University of California, San Francisco **Class:** OTHER **Name:** University of North Carolina, Chapel Hill #### Lead Sponsor **Class:** OTHER **Name:** Henry Ford Health System #### 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 the ALOFT study is to understand the health of women in the 12 years following a uterine fibroid (UF) treatment. ALOFT is a multi-center, prospective, observational cohort study of approximately 700 women who have undergone uterine-sparing treatment procedures for UF and previously participated in the longitudinal studies COMPARE-UF (NCT02260752) or ULTRA (NCT02100904). The primary uterine sparing treatment procedures undergone by study participants are myomectomy, endometrial ablation (EA), uterine artery embolization (UAE) and laparoscopic radiofrequency ablation (RFA). A smaller number of women may be studied who underwent focused ultrasound, intrauterine device (IUD), and medical management. Two follow-up study contacts with COMPARE-UF and ULTRA participants will occur to assess changes in UF symptoms and treatment failure which is defined as the need for another UF treatment procedure. Questionnaires will be used to collect data on patient-reported characteristics and outcomes and quality of life. The study's analyses will focus on comparisons of primary and secondary outcomes among women. ### Conditions Module **Conditions:** - Uterine Fibroid **Keywords:** - Uterine fibroid treatment - Multi-center, prospective, observational cohort study - Uterine-sparing treatment procedures - Patient-reported outcomes - Quality of life ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 700 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** NA- no intervention **Name:** NA- no intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The need for another uterine fibroid treatment procedure **Measure:** Time to treatment failure **Time Frame:** Up to 12 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participant has to have been enrolled in either the COMPARE-UF or ULTRA study * Participant had a uterine-sparing fibroid treatment at enrollment in COMPARE-UF or ULTRA study Exclusion Criteria: * Individuals who were not consented into the original COMPARE-UF or ULTRA study * Individuals who did not have a uterine-sparing fibroid treatment at enrollment in COMPARE-UF or ULTRA study **Gender Based:** True **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Participants who were previously enrolled in either the COMPARE-UF or ULTRA study ### Contacts Locations Module #### Locations **Location 1:** **City:** San Francisco **Country:** United States **Facility:** University of California San Francisco **State:** California **Zip:** 94143 **Location 2:** **City:** Detroit **Country:** United States **Facility:** Henry Ford Health **State:** Michigan **Zip:** 48202 **Location 3:** **City:** Rochester **Country:** United States **Facility:** Mayo Clinic **State:** Minnesota **Zip:** 55905 **Location 4:** **City:** Chapel Hill **Country:** United States **Facility:** The University of North Carolina at Chapel Hill **State:** North Carolina **Zip:** 27514 #### Overall Officials **Official 1:** **Affiliation:** Henry Ford Health **Name:** Ganesa Wegienka, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### See Also Links **Label:** ALOFT study landing page **URL:** https://www.henryford.com/hcp/research/aloft-study ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009379 - Term: Neoplasms, Muscle Tissue - ID: D000018204 - Term: Neoplasms, Connective and Soft Tissue - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009372 - Term: Neoplasms, Connective Tissue - ID: D000003240 - Term: Connective Tissue Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M10901 - Name: Leiomyoma - Relevance: HIGH - As Found: Fibroids - ID: M25846 - Name: Myofibroma - Relevance: HIGH - As Found: Fibroids - ID: M20350 - Name: Neoplasms, Connective and Soft Tissue - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M12317 - Name: Neoplasms, Connective Tissue - Relevance: LOW - As Found: Unknown - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007889 - Term: Leiomyoma - ID: D000047708 - Term: Myofibroma ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430307 **Brief Title:** Efficacy and Safety of Saussurea Involucrata Liquid Tonic in Patient With Postpartum Rheumatism **Official Title:** A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study of Saussurea Involucrata Liquid Tonic in the Treatment of Postpartum Rheumatism #### Organization Study ID Info **ID:** 2022014P7A01 #### Organization **Class:** OTHER **Full Name:** Guang'anmen Hospital of China Academy of Chinese Medical Sciences ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Quan Jiang #### Responsible Party **Investigator Affiliation:** Guang'anmen Hospital of China Academy of Chinese Medical Sciences **Investigator Full Name:** Quan Jiang **Investigator Title:** chief physician **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 is a multi-center, randomized, double-blinded, controlled trial with two parallel arms. The study aims to evaluate the efficacy and safety of Involucrata Liquid Tonic in patients with Postpartum Rheumatism. ### Conditions Module **Conditions:** - Postpartum Rheumatism **Keywords:** - Saussurea Involucrata Liquid Tonic - Traditional Chinese Medicine - Postpartum Rheumatism ### 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:** 128 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Saussurea Involucrata Liquid Tonic 20ml/time, 2 times a day, orally on an empty stomach. Total treatments 8 weeks, followed up to 12 weeks. **Intervention Names:** - Drug: Saussurea Involucrata Liquid Tonic **Label:** Saussurea Involucrata Liquid Tonic **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** placebo of Saussurea Involucrata Liquid Tonic 20ml/time, 2 times a day, orally on an empty stomach. Total treatments 8 weeks, followed up to 12 weeks. **Intervention Names:** - Drug: Saussurea Involucrata Liquid Tonic **Label:** placebo of Saussurea Involucrata Liquid Tonic **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Saussurea Involucrata Liquid Tonic - placebo of Saussurea Involucrata Liquid Tonic **Description:** This product is a single preparation of Saussurea Involucrata Liquid Tonic. It is used for rheumatoid arthritis, rheumatoid arthritis and dysmenorrhea caused by insufficient kidney yang and cold-damp stasis. **Name:** Saussurea Involucrata Liquid Tonic **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The number of cases with pain VAS (visual analog scale) improvement ≥30%/number of enrolled cases × 100%. **Measure:** VAS (visual analog scale) **Time Frame:** 8 weeks #### Secondary Outcomes **Description:** the MOS item short from health survey, SF-36 **Measure:** SF-36 **Time Frame:** 8 weeks **Description:** Hospital Anxiety and Depression Scale **Measure:** HADS **Time Frame:** 8 weeks **Description:** Stanford Health Assessment Questionnaire **Measure:** HAQ **Time Frame:** 8 weeks **Description:** Visual Analogue Score **Measure:** VAS **Time Frame:** 8 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Women experience joint and muscle pain, soreness, heaviness, numbness, etc. within 1 year after childbirth, miscarriage or induction of labor; with or without sensitivity to external stimuli such as wind, cold, moisture, etc., which may be induced or aggravated by emotional fluctuations * Meets the diagnostic criteria for Yang Qi deficiency and cold-dampness syndrome. * Age 18-50 * Pain VAS score ≥4cm Exclusion Criteria: * Those in the puerperium (within 42 days after delivery). * Those who have rheumatoid arthritis, ankylosing spondylitis, osteitis density, polymyalgia rheumatica, reactive arthritis, myofasciitis, fibromyalgia syndrome and other rheumatic immune diseases before pregnancy. * Severe abnormalities in blood routine and electrocardiogram, active liver disease or abnormal liver function, AST, ALT or GGT higher than 1.2 times the upper limit of normal value; abnormal renal function, serum creatinine (sCr) higher than 1.2 times the upper limit of normal value. Patients whose white blood cell count \< 3.0×109/L, or hemoglobin \< 90 g/L, or platelet count \< 100.0×109/L in routine blood examination * Combined with serious underlying diseases, primary diseases and postpartum diseases, such as uncontrollable hypertension, heart disease, kidney disease, puerperal fever, mastitis, moderate to severe postpartum depression diagnosed by a psychiatric department, etc. * Those who have a history of using glucocorticoids, immunosuppressants and other drugs within 4 weeks. * Those who are allergic to the ingredients of the test drug or have a high-sensitivity constitution. * Existing or past history of cancer. * Those who have participated in other clinical drug studies in the past 2 months. * Those who do not use the medication as prescribed, or who have incomplete information that affects the judgment of efficacy. **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000003240 - Term: Connective Tissue Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M15045 - Name: Rheumatic Diseases - Relevance: HIGH - As Found: Rheumatism - ID: M6323 - Name: Collagen Diseases - Relevance: HIGH - As Found: Rheumatism - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012216 - Term: Rheumatic Diseases - ID: D000003095 - Term: Collagen Diseases ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430294 **Brief Title:** Caracteristics of Pediatric Spinal Mobilizations **Official Title:** Force-time Characteristics of Spinal Mobilizations Delivered on Pediatric Manikins #### Organization Study ID Info **ID:** UQTR_IP_SIMULATIONS_2024 #### Organization **Class:** OTHER **Full Name:** Université du Québec à Trois-Rivières ### Status Module #### Completion Date **Date:** 2024-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Université du Québec à Trois-Rivières #### Responsible Party **Investigator Affiliation:** Université du Québec à Trois-Rivières **Investigator Full Name:** Isabelle Pagé **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:** This observational study aims to create simulations using pediatric manikins to teach pediatric spinal mobilizations. We'll measure the force and duration of spinal mobilizations applied by chiropractors on pediatric manikins. Another objective is to gather feedback from both students and teachers on the effectiveness of using manikins for teaching. The main questions it aims to answer are: 1. How much force and for how long do chiropractors apply spinal mobilizations on pediatric manikins? **Detailed Description:** This project aims to initiate the development of low-fidelity simulations to enhance the learning of skills associated with performing pediatric spinal mobilizations. This will be achieved by gathering target values for the force and duration of spinal mobilizations performed by chiropractors on pediatric manikins. ### Conditions Module **Conditions:** - Spinal Mobilization **Keywords:** - Chiropractic - Pediatric - Simulations ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 12 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Chiropractors will perform spinal mobilizations on three different pediatric-sized manikins while a sensor will measure the force and time parameters used. **Intervention Names:** - Other: Spinal mobilisation **Label:** Participants ### Interventions #### Intervention 1 **Arm Group Labels:** - Participants **Description:** Application of a force on pediatric manikins. **Name:** Spinal mobilisation **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The spinal mobilization will be delivered on a force sensor (Loadpad(R)) that will measured the force-time characteristics. The peak force reached during the therapy will be extracted. **Measure:** Peak force (N) reached during the spinal mobilization measured by a force sensor **Time Frame:** During the spinal mobilization **Description:** The spinal mobilization will be delivered on a force sensor (Loadpad(R)) that will measured the force-time characteristics. The duration of the therapy will be extracted. **Measure:** Duration (s) of spinal mobilization measured by a force sensor **Time Frame:** During the spinal mobilization ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Being a chiropractor in private practice and a member of the Ordre des chiropraticiens du Québec Exclusion Criteria: * Not been able to perform pediatric spinal mobilizations **Healthy Volunteers:** True **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Licensed chiropractors ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Isabelle Pagé, DC, PhD **Phone:** 819-376-5011 **Phone Ext:** 3885 **Role:** CONTACT #### Locations **Location 1:** **City:** Trois-Rivières **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Isabelle Pagé, DC, PhD - **Phone:** 819-376-5011 - **Phone Ext:** 3885 - **Role:** CONTACT **Country:** Canada **Facility:** Université Québec à Trois-Rivières **State:** Quebec **Status:** RECRUITING **Zip:** G8Z4M3 #### Overall Officials **Official 1:** **Affiliation:** Université du Québec à Trois-Rivières **Name:** Isabelle Pagé, DC, 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:** NCT06430281 **Brief Title:** Manual Therapy Force Perception Scale **Official Title:** Development and Pre-testing of a Manual Therapy Force Perception Scale #### Organization Study ID Info **ID:** UQTR_IP_EchelleTM_2024 #### Organization **Class:** OTHER **Full Name:** Université du Québec à Trois-Rivières ### Status Module #### Completion Date **Date:** 2024-07-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-04 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Université du Québec à Trois-Rivières #### Responsible Party **Investigator Affiliation:** Université du Québec à Trois-Rivières **Investigator Full Name:** Isabelle Pagé **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 objective of this observational study is to pilot a scale designed to assist clinicians in evaluating the force they perceive during manual therapy. The main question it aims to answer is: - Are clinicians able to evaluate the force they use when delivering manual therapies to their patients using a scale? For the pilot test, licensed chiropractors administer manual therapies on a manikin. **Detailed Description:** The aim of this observational study is to pilot test an ordinal scale (the Manual Therapy Force Perception \[MTFP\] scale) intended to enable clinicians to assign ordinal rankings to their patients based on their perception of the force they applied during manual therapy . This involved evaluating the agreement between the force applied by clinicians during spinal manipulations and mobilizations delivered on a manikin and their subjective perception of force, as determined using the MTFP scale. Additionally, the pilot study aimed to seek feedback on the MTFP scale from clinicians who are its potential users. ### Conditions Module **Conditions:** - Manual Therapy **Keywords:** - Chiropractic - Spinal mobilization - Spinal manipulation - force sensor ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 12 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Chiropractors will administer manual therapies on a manikin utilizing three distinct levels of force (typical force, low force, high force), determined by the trial label on the scale. A sensor will gauge the magnitude of force applied. **Intervention Names:** - Other: Manual therapy **Label:** Participants ### Interventions #### Intervention 1 **Arm Group Labels:** - Participants **Description:** A manual force will be applied to a manikin positioned on a chiropractic treatment table. The force exerted during the manual therapy must align with the trial label indicated on the Manual Therapy Force Perception \[MTFP\] scale. **Name:** Manual therapy **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The therapy will be delivered on a force sensor (Loadpad(R)) which will measured the force applied. The peak force reached during the therapy will be extracted. **Measure:** Peak force measured by a force sensor during the manual therapy **Time Frame:** During the manual therapy ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Licensed chiropractors with a private practice within the province of Quebec, Canada. Exclusion Criteria: * Having a condition that prevents the execution of approximately 50 manual therapies over a 1-hour period. **Healthy Volunteers:** True **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Licensed chiropractors ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Isabelle Pagé, DC, PhD **Phone:** 819-376-5011 **Phone Ext:** 3885 **Role:** CONTACT #### Locations **Location 1:** **City:** Trois-Rivières **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Isabelle Pagé, DC, PhD - **Phone:** 819-376-5011 - **Phone Ext:** 3885 - **Role:** CONTACT ***Contact 2:*** - **Name:** Isabelle Pagé, DC, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Canada **Facility:** Université du Québec à Trois-Rivières **State:** Quebec **Status:** RECRUITING **Zip:** G8Z 4M3 #### Overall Officials **Official 1:** **Affiliation:** Université du Québec à Trois-Rivières **Name:** Isabelle Pagé, DC, 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:** NCT06430268 **Brief Title:** Efficacy of Non-surgical and Surgical Surface Decontamination Methods on Peri-implantitis-affected Implants **Official Title:** Efficacy of Non-surgical and Surgical Surface Decontamination Methods on Peri-implantitis-affected Implants: A Randomized Clinical Trial #### Organization Study ID Info **ID:** STUDY23100029 #### Organization **Class:** OTHER **Full Name:** University of Pittsburgh ### Status Module #### Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-21 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Association for Dental Infection Control #### Lead Sponsor **Class:** OTHER **Name:** Andrea Ravida #### Responsible Party **Investigator Affiliation:** University of Pittsburgh **Investigator Full Name:** Andrea Ravida **Investigator Title:** Assistant Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study will compare 2 methods to clean contaminated implant surfaces: air-polishing device versus titanium curette. Both of these methods will be used in the non-surgical and surgical setting, followed by implant removal. Then, in-vitro analysis to assess the efficacy of surface decontamination will be performed. **Detailed Description:** A screening visit will be performed to determine the elegibility of the individuals to participate in the study. Information related to the target implant (e.g., brand, material, surface, dimensions, time of function, history of treatment of peri-implantitis) and reconstruction (e.g., cemented or screwed prosthesis, single, multi-unit or full-arch) will be collected. Intra-oral radiographs will be obtained or exported from patients' dental records, and the marginal bone level (MBL) will be measured at the mesial and distal aspects of the implants by one calibrated investigator using an image analysis software (Image J; National Institutes of Health, Bethesda, MD, USA). The anatomy of the bone defect will be determined. Randomization will be performed in a stratified manner, in sets of 10 implants, by a computer software, to obtain equally balanced groups based on implant characteristics (site, brand, design). A researcher not involved in the clinical interventions will be responsible for randomization. At the day of implant removal, a single calibrated examiner will assess the following parameters at six sites around each experimental implant using an UNC 15 periodontal probe: (1) Plaque accumulation, using the modified plaque index \[mPI\]; (2) Probing depth (mm); (3) Bleeding on probing, using the modified gingival index \[mGI\] ; (4) Suppuration; (5) Recession (mm). The width of keratinized mucosa (KM) will be obtained in the mid-buccal and mid-lingal aspect of the implants (mm). A standard tessellation language (STL) file of the arch of interest using an intraoral optical scanner (Trios 3, 3Shape, Denmark) will be obtained. Surface decontamination protocols: All cleaning procedures will be performed without the suprastructures. A notch will be performed on the buccal side of all implant shoulders with the aid of a bur, in order to distinguish the different implant surfaces during the microbiological and biocompatibility analysis phases. Following local anesthesia, implants will be randomly assigned to the following study groups: 1. Non-surgical decontamination with titanium curettes prior to implant removal (n = 20); 2. Non-surgical decontamination with erythritol powder prior to implant removal (n = 20); 3. Surgical decontamination with titanium curettes prior to implant removal (n = 20); 4. Surgical decontamination with erythritol powder prior to implant removal (n = 20); 5. No decontamination prior to implant removal (n=10). In the surgical groups, intra-sulcular and, if necessary, vertical releasing incisions will be performed. Full-thickness flaps will be elevated in the buccal and lingual aspects and the granulation tissue will be removed. All giant (visible) calculus will be removed with an ultrasonic tip in advance, without touching the implant surface directly. Copious irrigation with saline will be performed in both groups prior to implant decontamination. All implants will be cleaned by the same operator with the aid of dental surgical loupes. The time needed for the operator to consider the implant surface clean will be recorded. * Titanium curettes (Hu-Friedy, Chicago, Illinois, USA) will be used for supra and submucosal around the implants. * Air-polishing (Airflow Prophylaxis Master, EMS, Nyon, Switzerland) will be carried out with AIR-FLOW powder PLUS (EMS) containing erythritol (sugar alcohol, 14 μm), amorphous silica and 0.3% chlorhexidine. The device will be adjusted to a power setting of 5 bar static pressure and a maximum level of irrigation with water. * Non-surgical group: The supramucosal implant surfaces will be cleaned with the Airflow handpiece, while for the submucosal areas, a Perioflow handpiece and nozzle for submucosal instrumentation will be used. The nozzle will be changed after cleaning each implant. * Surgical group: The Airflow handpiece will be moved in a horizontal direction along implant threads from an apical to a coronal position. The angulation of the handpiece and working distance will not be standardized as they may vary according to the area being cleaned. Implant removal: Once the decontamination procedure has been completed, all the implants will be explanted with the aid of a reverse torque device (Implant Removal Kit; Zimmer Biomet); no trephines will be used. During the procedure, care will be taken to avoid damage to the implant and its surface. The retrieved implants will be immersed in a transport medium (Dulbecco's Modified Eagle Medium) and stored in sterile plastic vials at 4°C until further analysis. In all study groups, the explanted sites will be again curetted and the soft tissues will be sutured with interrupted or crossed sutures. Subjects will receive detailed verbal and written postoperative instructions, as well as a prescription for anti-inflammatory medication (ibuprofen \[600mg\], for 3-5 days, as needed for pain control). Patients will be instructed to rinse gently with 0.12% chlorhexidine twice daily for 1 week. Sutures will be removed after 2 weeks. Subsequently, a second randomization will take place to direct each implant (n = 10 in each decontamination group) for microbiological/elementary composition analysis and biocompatibility analysis. In-vitro analysis post surface decontamination includes assessing the cleaning efficacy, microbiological analysis, biocompatibility analysis including cultivation of cells, RNA extraction, Reverse Transcription (RT) and Real-Time RT-Polymerase Chain Reaction (Real-Time RT-PCR) , and elementary composition analysis including implant surface degradation, corrosion performance and atomic composition. ### Conditions Module **Conditions:** - Peri-Implantitis - Dental Implant Failed **Keywords:** - Peri-implantitis - Decontamination - Implant Surface ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Titanium curettes (Hu-Friedy, Chicago, Illinois, USA) will be used for supra and submucosal around the implants without any flap elevation. **Intervention Names:** - Procedure: implant decontamination with titanium curette **Label:** Non-surgical decontamination with titanium curettes followed by explantation **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Without any flap elevation, the supramucosal implant surfaces will be cleaned with the Airflow handpiece, while for the submucosal areas, a Perioflow handpiece and nozzle for submucosal instrumentation will be used. The nozzle will be changed after cleaning each implant. **Intervention Names:** - Device: implant decontamination with Air-Flow device **Label:** : Non-surgical decontamination with erythritol powder prior to implant removal **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Intra-sulcular and, if necessary, vertical releasing incisions will be performed. Full-thickness flaps will be elevated in the buccal and lingual aspects and the granulation tissue will be removed. Titanium curettes (Hu-Friedy, Chicago, Illinois, USA) will be used for supra and submucosal around the implants **Intervention Names:** - Procedure: implant decontamination with titanium curette **Label:** Surgical decontamination with titanium curettes prior to implant removal **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Intra-sulcular and, if necessary, vertical releasing incisions will be performed. Full-thickness flaps will be elevated in the buccal and lingual aspects and the granulation tissue will be removed.The Airflow handpiece will be moved in a horizontal direction along implant threads from an apical to a coronal position. The angulation of the handpiece and working distance will not be standardized as they may vary according to the area being cleaned. **Intervention Names:** - Device: implant decontamination with Air-Flow device **Label:** Surgical decontamination with erythritol powder prior to implant removal **Type:** EXPERIMENTAL #### Arm Group 5 **Description:** No decontamination will be performed on implants in this group. **Label:** No decontamination prior to implant removal **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Non-surgical decontamination with titanium curettes followed by explantation - Surgical decontamination with titanium curettes prior to implant removal **Description:** Titanium curettes (Hu-Friedy, Chicago, Illinois, USA) will be used for supra and submucosal around the implant, with and without flap elevation. **Name:** implant decontamination with titanium curette **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - : Non-surgical decontamination with erythritol powder prior to implant removal - Surgical decontamination with erythritol powder prior to implant removal **Description:** Air-polishing (Airflow Prophylaxis Master, EMS, Nyon, Switzerland) will be carried out with AIR-FLOW powder PLUS (EMS) containing erythritol (sugar alcohol, 14 μm), amorphous silica and 0.3% chlorhexidine to decontaminate implants with and without flap elevation. The device will be adjusted to a power setting of 5 bar static pressure and a maximum level of irrigation with water. **Name:** implant decontamination with Air-Flow device **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The cleaned surface area will be planimetrically recorded, and the percentage presence/absence of mineralized deposits as well as scratches on the decontaminated implant surfaces will be determined with the aid of a stereomicroscope. **Measure:** Percentage of clean implant surface area following implant decontamination approaches **Time Frame:** Right after decontamination and implant removal (T0) #### Secondary Outcomes **Description:** Shotgun metagenomic sequencing will be used to identify the bacterial composition in the residual biofilms. **Measure:** Bacterial composition of the implants **Time Frame:** Right after decontamination and implant removal (T0) **Description:** Cultivation of osteoblastic cells will be performed and assessed on the implants. **Measure:** Biocompatibility analysis of the implant **Time Frame:** Right after decontamination and implant removal (T0) **Description:** SEM images of the surfaces of negative control implants (brand new) and treated implants for each decontamination method will be exemplarily taken after instrumentation and cell culture. **Measure:** Scanning electron microscopy analysis of the cells and residual bacterial deposits **Time Frame:** Right after decontamination and implant removal (T0) **Description:** Patients will be asked to fill out a questionnaire. **Measure:** Patient satisfaction with the decontamination devices **Time Frame:** Right after decontamination and implant removal (T0) **Description:** Incidence of complications will be recorded by the clinician performing the intervention. **Measure:** Incidence of complications **Time Frame:** Right after decontamination and implant removal (T0) **Description:** Three-dimensional images and roughness line profiles will be acquired by laser scanning confocal microscopy. **Measure:** Implant surface degradation **Time Frame:** Right after decontamination and implant removal (T0) **Description:** In vitro electrochemical tests will be conducted to determine the corrosion performance. **Measure:** Corrosion performance **Time Frame:** Right after decontamination and implant removal (T0) **Description:** The atomic composition of the surface of the decontaminated implants will be examined using energy-dispersive x-ray spectroscopy (EDS). **Measure:** Atomic composition of the implants after removal **Time Frame:** Right after decontamination and implant removal (T0) ### Eligibility Module **Eligibility Criteria:** Inclusion criteria: (1) Adult individuals between 18 and 80 years of age who require the explantation of at least one titanium or titanium alloy implant due to severe peri-implantitis (\> 50% bone loss and signs of inflammation); (2) Individuals who did not undergo surgical or non-surgical peri-implant therapy in the previous 6 months. Exclusion criteria: (1) Acute infection associated with adjacent teeth; (2) Any technical complication that does not allow implant removal using a reverse torque device; (3) Active infectious diseases of any kind; (4) Medical conditions which requires premedication prior to dental treatments/visits; (5) Pregnant women or planning to become pregnant (self-reported); (6) History of radiotherapy in the head and neck or chemotherapy in the last 3 years; (7) Any other diseases or medications that may contraindicate the surgical procedure or compromise wound healing. **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:** Andrea Ravida, DDS MS PhD **Phone:** (734) 730-9678 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Carla Sanchez, MS **Phone:** (412) 624-1179 **Role:** CONTACT #### Locations **Location 1:** **City:** Pittsburgh **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Andrea Ravida, DDS,MSc, PhD - **Phone:** 734-730-9678 - **Role:** CONTACT **Country:** United States **Facility:** University of Pittsburgh, School of Dental Medicine **State:** Pennsylvania **Status:** RECRUITING **Zip:** 15213 #### Overall Officials **Official 1:** **Affiliation:** University of Pittsburgh **Name:** Andrea Ravida, DDS MS PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010510 - Term: Periodontal Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M28893 - Name: Peri-Implantitis - Relevance: HIGH - As Found: Peri-implantitis - 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: D000057873 - Term: Peri-Implantitis ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: VaDiAg - Name: Vasodilator Agents ### Intervention Browse Module - Browse Leaves - ID: M5953 - Name: Chlorhexidine - Relevance: LOW - As Found: Unknown - ID: M344731 - Name: Chlorhexidine gluconate - Relevance: LOW - As Found: Unknown - ID: M3777 - Name: Ethanol - Relevance: LOW - As Found: Unknown - ID: M8050 - Name: Erythritol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06430255 **Brief Title:** Effects of Global Postural Re-education Versus Laser-guided Exercise in Non-specific Chronic Low Back Pain **Official Title:** Effects of Global Postural Re-education Versus Laser-guided Supervised Exercise in Individuals With Non-specific Chronic Low Back Pain: A Randomized Controlled Clinical Trial #### Organization Study ID Info **ID:** 24-1243 #### Organization **Class:** OTHER **Full Name:** Taif University ### Status Module #### Completion Date **Date:** 2024-06-25 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-06-25 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-16 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Taif University #### Responsible Party **Investigator Affiliation:** Taif University **Investigator Full Name:** Alaa Saleh Baboor **Investigator Title:** Physical Therapist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Effects of Global Postural Re-education Versus Laser-guided Supervised Exercise in Individuals With Non-specific Chronic Low Back Pain **Detailed Description:** The objective of this study will be to investigate the effectiveness of GPR or LGE, in addition to PNE and home exercise program. The primary outcomes will be pain intensity, disability, and fingertip to floor test. The secondary outcomes will be pain catastrophizing, kinesiophobia and depression. ### Conditions Module **Conditions:** - Pain, Back ### 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:** is a physical therapy method developed in France by Philippe-Emmanuel Souchard. This therapy method is founded on an integrated concept of the muscular system, which is composed of muscle chains. These muscle chains are susceptible to shortening as a result of constitutional, behavioral, and psychological factors, Patients allocated to this group will be having a GPR method course of 8 sessions, two sessions per week for a four-week period. Each session will consist of 3 therapeutic postures, lying, sitting, or standing, to be held for 15-20 minutes each. The postures used are considered the most effective in lengthening the posterior chain, which is usually shortened in patients with LBP. **Intervention Names:** - Other: Global Postural Re-education **Label:** Global Postural Re-education **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients allocated to this group will be having a LGSE method course of 8 sessions, two sessions per week for a four-week period. Each session will consist of lumbar movement control exercises. The physiotherapist responsible for the intervention corrected each participant individually as required when performing the movement control exercises to ensure the correct technique. The exercises is progress from the supine position through to standing, 4-point kneeling. The program consists of 8 exercises first starting with abdominal-diaphragmatic breathing and isolated contraction of the transversus abdominis contractions of 10 seconds' duration 5 repetition, Abdominal preparation, Pelvic elevation with previous transversus abdominis contraction and neutral pelvis, **Intervention Names:** - Other: Laser-guided Supervised Exercise **Label:** Laser-guided Supervised Exercise **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Global Postural Re-education **Description:** Program for treatment **Name:** Global Postural Re-education **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Laser-guided Supervised Exercise **Description:** Program for treatment **Name:** Laser-guided Supervised Exercise **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** assessed using the Numerical Pain Rating Scale which goes from 0 ("no pain at all") to 10 ("worst imaginable pain") **Measure:** Pain intensity **Time Frame:** One month **Description:** modified Oswestry Low Back Pain Disability (ODI) questionnaire Each part has six statements rated from 0 (least difficult to accomplish action) to 5 (most difficult) The overall score goes from 0 to 50 (the greatest impairment) In individuals with LBP **Measure:** Disability **Time Frame:** 7 weeks **Description:** excellent metric properties for LBP **Measure:** Fingertip-to-floor test **Time Frame:** 7 weeks #### Secondary Outcomes **Description:** will be used to measure pain catastrophizing. Scores range from 0 (never) to 4 (always) for each item (total score = 0-52). Higher ratings reflect more catastrophizing of pain **Measure:** Pain catastrophizing **Time Frame:** One month **Description:** will be assessed using the 11 items that make up the TSK-11. The overall score is between 11 and 44 points. A higher score indicates a greater fear of discomfort, movement, and harm. **Measure:** Kinesiophobia **Time Frame:** One month **Description:** Patient Health Questionnaire (PHQ-9), The PHQ-9 is a self-administered 9-item questionnaire with four statements ranging from 0 (not at all) to 3 (nearly every day) for each item. A higher total score (20-27) suggests that the patient is suffering from severe depression. **Measure:** Depression **Time Frame:** 4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged between 18 and 45 years. * Diagnosed with NSLBP. * Experiencing NSCLBP for ≥ 3 months and score at least 3/10 on the Numerical Pain Rating Scale (NPRS). Exclusion Criteria: * Diagnosed with a condition that hinders their ability to engage in physical exercise (e.g., uncontrolled diabetes, cardiovascular disease, orthopedic impairments; balancing problems). * Diagnosed with severe spine conditions (such as fractures, tumors, ankylosing spondylitis, or inflammatory disorders). * Diagnosed with neurological problems (such as spine nerve problems or cauda equina syndrome) * Diagnosed with mental illness or severe cognitive impairment that made it impossible to follow the PNE program. * With a physical condition that made it impossible to complete the PNE program (the timed "up and go" test had to be completed in 10 seconds at a minimum). * Receiving alternate therapy for related pathologies (myopathies and neurological diseases) that prevented them from completing the PNE program. **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Alaa Baboor **Phone:** 966596628155 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Ibrahim Alkayshan **Phone:** 966501272615 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Taif University **Name:** Hosam Alzahrani, Dr **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## 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: M4714 - Name: Back Pain - Relevance: HIGH - As Found: Pain, Back - 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 - ID: T1303 - Name: Chronic Graft Versus Host Disease - 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