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## Protocol Section ### Identification Module **NCT ID:** NCT06441968 **Brief Title:** Safety and Immunogenicity Trial of MPV/S-2P SARS-CoV-2 Vaccine in Adults **Official Title:** A Phase 1 Open-Label Safety and Immunogenicity Trial of MPV/S-2P, a Next Generation SARS-CoV-2 Booster Vaccine, in Previously Vaccinated Adults #### Organization Study ID Info **ID:** 23-1101 #### Organization **Class:** NIH **Full Name:** National Institute of Allergy and Infectious Diseases (NIAID) ### Status Module #### Completion Date **Date:** 2025-07-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-18 **Type:** ESTIMATED **Status Verified Date:** 2024-05-29 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-31 **Study First Submit QC Date:** 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** NIH **Name:** National Institute of Allergy and Infectious Diseases (NIAID) #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False ### Description Module **Brief Summary:** A clinical trial to evaluate the safety, reactogenicity, and immunogenicity of MPV/S-2P administered intranasally to adults who have previously received a primary series and at least one booster with an authorized or licensed mRNA SARS-CoV-2 parenteral vaccine. The primary objective is to evaluate the safety and reactogenicity of a single dose of MPV/S-2P in previously vaccinated healthy adults. **Detailed Description:** A phase I clinical trial to evaluate the safety, reactogenicity, and immunogenicity of MPV/S-2P administered intranasally to adults who have previously received a primary series and at least one booster with an authorized or licensed mRNA SARS-CoV-2 parenteral vaccine. The study is designed as a non-randomized, open-label, dose-escalation clinical trial in non-pregnant adult participants, 18-64 years of age (with a goal of 30 percent or more \>/=50 years of age), with or without prior SARS-CoV-2 infection, who are in good health and meet all other eligibility criteria. For the evaluation of three doses of MPV/S-2P vaccine, a sample size of 60 participants is anticipated. To evaluate for early safety signals vaccination will proceed in a staged fashion. For Cohort 1, three sentinel participants under 50 years of age will be enrolled over at least 2 days. A safety review of clinical data and virologic shedding data through at least Day 8 will be conducted by the Safety Review Committee (SRC) prior to enrollment of the remainder of the cohort. Once Cohort 1 is fully enrolled, progression to Cohort 2 will be based on evaluation of halting rules, and cumulative clinical safety and virologic shedding data from Cohort 1 through at least Day 8 by the SRC. Cohort 2 and 3 enrollment and safety oversight will proceed in the same fashion as Cohort 1. At the discretion of the SRC, additional participants in the cohort may be designated sentinels for any cohort. If halting rules are met the study will be paused for the SRC safety data review. The primary objective is to evaluate the safety and reactogenicity of a single dose of MPV/S-2P in previously vaccinated healthy adults. The secondary objectives are 1) To evaluate the systemic anti-Spike humoral immune responses after vaccination 2) To evaluate nasal mucosal IgA and IgG responses after vaccination 3) To assess the duration and magnitude of viral vector (vaccine) shedding 4) To assess the immune response towards the vector. ### Conditions Module **Conditions:** - COVID-19 **Keywords:** - adults - MPV/S-2P - phase 1 - SARS-CoV-2 - trial - vaccine ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Healthy adults between 18 - 64 years who have received a primary series and at least one booster with an authorized or licensed mRNA SARS-CoV-2 parenteral vaccine will receive 1 x 10\^4 PFU of MPV/S-2P administered intranasally (approximately 0.5 mL per nostril) using VaxINator (Teleflex) for 1 year. N=20 **Intervention Names:** - Biological: MPV/S-2P **Label:** Cohort 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Healthy adults between 18 - 64 years who have received a primary series and at least one booster with an authorized or licensed mRNA SARS-CoV-2 parenteral vaccine will receive 1 x 10\^5 PFU of MPV/S-2P administered intranasally (approximately 0.5 mL per nostril) using VaxINator (Teleflex) for 1 year. N=20 **Intervention Names:** - Biological: MPV/S-2P **Label:** Cohort 2 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Healthy adults between 18 - 64 years who have received a primary series and at least one booster with an authorized or licensed mRNA SARS-CoV-2 parenteral vaccine will receive 1 x 10\^6 PFU of MPV/S-2P administered intranasally (approximately 0.5 mL per nostril) using VaxINator (Teleflex) for 1 year. N=20 **Intervention Names:** - Biological: MPV/S-2P **Label:** Cohort 3 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Cohort 1 - Cohort 2 - Cohort 3 **Description:** A live murine pneumonia virus (MPV) vector expressing an additional SARS-CoV-2 S-protein, stabilized in its prefusion form, is being tested for its efficacy in protecting against the SARS-CoV-2 virus. It is speculated to be a next-generation vaccine for COVID-19. **Name:** MPV/S-2P **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Measure:** Frequency of abnormal clinical safety laboratory AEs **Time Frame:** Day 8 **Measure:** Frequency of solicited local adverse events (AEs) **Time Frame:** Through Day 14 following vaccination **Measure:** Frequency of systemic adverse events (AEs) **Time Frame:** Through Day 14 following vaccination **Measure:** Frequency of unsolicited AEs **Time Frame:** Through Day 28 following vaccination **Measure:** Occurrence of adverse events of special interest (AESIs) **Time Frame:** Through Month 12 after vaccination **Measure:** Occurrence of medically-attended adverse events (MAAEs) **Time Frame:** Through Month 12 after vaccination **Measure:** Occurrence of new-onset chronic medical conditions (NOCMCs) **Time Frame:** Through Month 12 after vaccination **Measure:** Occurrence of serious adverse events (SAEs) **Time Frame:** Through Month 12 after vaccination **Measure:** Severity of abnormal clinical safety laboratory AEs **Time Frame:** Day 8 **Measure:** Severity of solicited local adverse events (AEs) **Time Frame:** Through Day 14 following vaccination **Measure:** Severity of systemic adverse events (AEs) **Time Frame:** Through Day 14 following vaccination **Measure:** Severity of unsolicited AEs **Time Frame:** Through Day 28 following vaccination #### Secondary Outcomes **Measure:** Geometric Mean Fold Rise (GMFR) of anti-vector antibodies **Time Frame:** Through Day 366 **Measure:** Geometric Mean Fold Rise (GMFR) of mucosal anti-S binding antibodies (IgA, IgG) **Time Frame:** Through Day 366 **Measure:** Geometric Mean Fold Rise (GMFR) of serum anti-S binding antibody (IgA and IgG) **Time Frame:** Through Day 366 **Measure:** Geometric Mean Fold Rise (GMFR) of serum neutralizing antibodies to Spike variants **Time Frame:** Through Day 366 **Measure:** Geometric Mean Titer (GMT) of anti-vector antibodies **Time Frame:** Through Day 366 **Measure:** Geometric Mean Titer (GMT) of mucosal anti-S binding antibodies (IgA, IgG) **Time Frame:** Through Day 366 **Measure:** Geometric Mean Titer (GMT) of serum anti-S binding antibody (Immunoglobulin A (IgA) and Immunoglobulin G (IgG )) **Time Frame:** Through Day 366 **Measure:** Geometric Mean Titer (GMT) of serum neutralizing antibodies to Spike variants **Time Frame:** Through Day 366 **Measure:** Median nasal swab quantitative polymerase chain reaction (qPCR) copy number for murine pneumonia virus (MPV) **Time Frame:** Through Day 29 **Measure:** Percentage of participants positive for anti-vector antibodies **Time Frame:** Through Day 366 **Description:** Defined as a fourfold rise in serum neutralizing antibody titers **Measure:** Percentage of participants who seroconverted **Time Frame:** Day 29 **Measure:** Percentage of participants with polymerase chain reaction (PCR)-positive nasal swab for murine pneumonia virus (MPV) **Time Frame:** Through Day 29 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Provides written informed consent prior to initiation of any study procedures. 2. Able to understand and agrees to comply with planned study procedures and be available for all study visits. 3. Non-pregnant adults, 18-64 years of age at time of vaccination. 4. Participants of childbearing potential \* must agree to use or have practiced true abstinence \*\* or use at least one acceptable primary form of contraception \*\*\* \* These criteria are applicable to persons assigned female at birth who have sexual intercourse with a person assigned male at birth, and who are of childbearing potential. Not of childbearing potential include post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy, or Essure (R) placement) \*\* True abstinence is 100 percent of time no sexual intercourse (penis enters the vagina). Periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception \*\*\* Acceptable forms of primary contraception include monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more prior to the participant's vaccination, intrauterine devices, birth control pills, and injectable/implantable/insertable/transdermal hormonal birth control products. Must have used at least one acceptable primary form of contraception for at least 30 days prior to vaccination and agree to continue at least one acceptable primary form of contraception through 60 days after vaccination 5. Participants of childbearing potential must have a negative urine pregnancy test at screening and within 24 hours prior to study vaccination. 6. In general good health\*. \*As determined by medical history and physical examination, including vital signs, to evaluate acute or ongoing chronic medical diagnoses/conditions that have been present for at least 90 days, which would affect the assessment of safety of participants. Chronic medical diagnoses/ conditions should be stable for the last 30 days (i.e., no hospitalizations, ER, or urgent care for condition). This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis/condition in the 30 days before study vaccination. Any prescription change that is due to change of health care provider, insurance company, etc., or done for financial reasons, and in the same class of medication, will not be considered a deviation of this inclusion criterion. Participants may be on chronic or as needed (prn) medications if, in the opinion of the participating site PI or appropriate sub-investigator, they pose no additional risk to participant safety or assessment of reactogenicity and immunogenicity. 7. Receipt of a complete primary COVID-19 mRNA vaccine series and at least one mRNA booster\* with last vaccination at least 16 weeks prior to study vaccination. \*Booster may be either homologous or heterologous to the primary vaccine series and must be an FDA authorized/licensed mRNA vaccine though doses may have been received as part of a clinical trial. 8. Clinical screening laboratory evaluations are within normal reference ranges or grade 1 with no clinical significance (NCS) per investigator discretion\*. * White Blood Cells \[WBCs\] with differential, hemoglobin \[Hgb\], platelets \[PLTs\], Alanine Transaminase \[ALT\], Aspartate Transaminase \[AST\], Creatinine \[Cr\], Alkaline Phosphatase \[ALP\], Total Bilirubin \[T. Bili\]). ALT, AST, ALP, T. Bili and creatinine values that are below the reference range will not be exclusionary as these values below reference range are clinically insignificant. 9. Must agree to have samples stored for secondary research. 10. Non-smokers or non-habitual\* smokers of tobacco, e-cigarettes, or marijuana. \*Non-habitual smokers are those who smoke no more than four cigarettes, other tobacco products, e-cigarettes (to include vaping and Juuling products) or marijuana products in a week. 11. Must agree to wearing a surgical mask (or KN-95 or N-95) when in close proximity to others (within 6 feet) for 14 days after study vaccination, and potentially longer if asked by study team based on data gathered. Exclusion Criteria: 1. Positive SARS-CoV-2 PCR at screening. 2. Abnormal vital signs (Grade 1 or higher)\* \*Grade 1 or higher is equivalent to: Systolic blood pressure (SBP) \>/= 141 mmHg or \</= 89 mmHg Diastolic blood pressure (DBP) \>/= 91 mmHg Heart rate (HR) is \>/= 101 beats per minute or \</= 54 beats per minute Oral temperature \>/= 38.0°C (100.4°F) 3. History of SARS-CoV-2 infection or receipt of any COVID-19 vaccine \< 16 weeks prior to study vaccination. 4. Participant who is pregnant or breastfeeding. 5. Blood or plasma donation within 4 weeks prior to study vaccination. 6. Receipt of antibody or blood-derived products within 90 days prior to study vaccination. 7. Any self-reported or medically documented significant medical or psychiatric diseases\* or any other condition that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation. \*Significant medical or psychiatric conditions include but are not limited to respiratory disease (e.g., chronic obstructive pulmonary disease \[COPD\]) requiring daily medications currently, history of asthma in the past 5 years, or any treatment of respiratory disease exacerbations in the last 5 years. Significant kidney disease, liver disease, or cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease), including any history of myocarditis or pericarditis, or uncontrolled cardiac arrhythmia. Neurological or neurodevelopmental conditions (e.g., history of Bell's palsy, history of four or more migraine headaches in the past 12 months that interfered with normal daily activity or any migraine headache in the past 5 years that required emergency or inpatient medical care, epilepsy, seizures in the last 5 years, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis, transverse myelitis, stroke or transient ischemic attack, multiple sclerosis, Parkinson's disease, amyotrophic lateral sclerosis, Creutzfeldt-Jakob disease, or Alzheimer's disease). Ongoing malignancy or recent diagnosis of malignancy in the last five years excluding treated basal cell and squamous cell carcinoma of the skin, which are allowed. Any autoimmune disease, including hypothyroidism without a defined non-autoimmune cause. 8. Any significant nasal or upper airway disease\*. \*(Including, but not limited to, being prone to epistaxis, a history of inflammatory rhinitis (including allergic rhinitis) that requires daily medications, cochlear implants, head/neck radiation history, anosmia/dysosmia, conditions that require prescription or over the counter intranasal medication (intermittent use will be allowed if no use occurred for 30 days before study vaccination and participant agrees to not use intranasal medication (other than steroids) for 30 days after study vaccination and to not use intranasal steroids for 6 months after study vaccination), and certain ear, nose and throat (ENT) conditions, including significant upper airway/nasopharyngeal disease or abnormal anatomy such as CSF leak. 9. Has an acute illness, as determined by the site PI or appropriate sub-investigator within 72 hours prior to study vaccination\*. \*An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the participating site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol. 10. Has a positive test result for hepatitis B surface antigen, hepatitis C virus RNA (by reflex testing), or human immunodeficiency virus (HIV) antigen/antibody test at screening. 11. Has any confirmed or suspected immunosuppressive or immunodeficient state such as asplenia, recurrent severe infections and chronic\* immunosuppressant medication within the past 6 months\*\*. \*Chronic meaning more than 14 continuous days. \*\*Ophthalmic and topical steroids are allowed, see exclusion 19 for intranasal steroids. 12. Has received any investigational product within 60 days, or 5 half-lives, whichever is longer, before vaccination; or is planning to receive one during the study. 13. Has a history of hypersensitivity or severe allergic reaction\* to any previous licensed or unlicensed vaccine or to the candidate vaccine components. \*(e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) 14. Resides in or works in a nursing home or other skilled nursing facility. 15. Resides with or cares for immunocompromised persons, pregnant individuals, or children under 2 years of age (inclusive of health care workers and others with patient contact in health care settings). 16. People who handle rodents (laboratory workers, vivarium workers, pet store workers, etc.) or keep rodents as pets. 17. Received or plans to receive licensed inactivated/subunit vaccine within 14 days of study vaccine administration or live vaccine within 28 days of study vaccine administration. 18. Plan to receive a COVID-19 booster vaccine within the 180 days following study vaccination. 19. Regular use of intranasal medications including steroids\*. \*Participant must have had no intranasal medication use for 30 days prior to study vaccination and plans not to use intranasal medications for 30 days after study vaccination for medications other than steroids, and for 6 months after study vaccination for intranasal steroids (including over-the-counter Flonase). 20. Use of intranasal illicit drugs in the 5 years prior to study vaccination or plans to use during the study. 21. Planned international travel in the period between vaccination through Day 29 visit. **Healthy Volunteers:** True **Maximum Age:** 64 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Hana M El Sahly **Phone:** 17137982058 **Role:** CONTACT #### Locations **Location 1:** **City:** Decatur **Country:** United States **Facility:** The Hope Clinic of Emory University **State:** Georgia **Zip:** 30030-1705 **Location 2:** **City:** Mineola **Country:** United States **Facility:** NYU Grossman Long Island School of Medicine - Vaccine Center **State:** New York **Zip:** 11501 **Location 3:** **City:** Houston **Country:** United States **Facility:** Baylor College of Medicine **State:** Texas **Zip:** 77030-3411 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M2561 - Name: COVID-19 - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Browse Branches - Abbrev: VaCoAg - Name: Vasoconstrictor Agents - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M7992 - Name: Epinephrine - Relevance: LOW - As Found: Unknown - ID: M17360 - Name: Vaccines - Relevance: LOW - As Found: Unknown - ID: M1804 - Name: Carbamide Peroxide - Relevance: LOW - As Found: Unknown - ID: M30371 - Name: Racepinephrine - Relevance: LOW - As Found: Unknown - ID: M211043 - Name: Epinephryl borate - Relevance: LOW - As Found: Unknown - ID: M64702 - Name: Somatomedin B - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441955 **Brief Title:** Covid-19 Long Haul Preventative and Health Promotion Care Clinical Trial Acceleration Program. **Official Title:** Covid-19 Long Haul Syndrome: Undiagnosed Disorder Post Covid-19 Alternative Treatment Study. #### Organization Study ID Info **ID:** aou-rw-c6288c3f #### Organization **Class:** NETWORK **Full Name:** Well- Konnect Healthcare Services and Research Firm ### Status Module #### Completion Date **Date:** 2030-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-02 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2030-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-06-02 **Study First Submit QC Date:** 2024-06-02 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** All of Us Research Program at the National Institute of Health #### Lead Sponsor **Class:** NETWORK **Name:** Well- Konnect Healthcare Services and Research Firm #### 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:** We are conducting a study on alternative treatments for patients who have received an current or previous positive COVID-19 diagnosis with mild-serve symptoms or undiagnosable condition after testing positive for severe acute COVID-19 infection and are experiencing long-haul symptoms. The symptoms of long COVID can include extreme tiredness (fatigue), shortness of breath, memory and concentration issues (brain fog), heart palpitations, dizziness, joint pain, muscle aches, cough, headaches, anxiety, and depression. It's important to note that there are various other symptoms that individuals can experience after a COVID-19 infection, such as loss of smell, chest pain or tightness, difficulty sleeping (insomnia), pins and needles, depression, anxiety, tinnitus, earaches, nausea, diarrhea, stomach aches, loss of appetite, cough, headaches, sore throat, and changes to the sense of smell or taste. To be included in the study, participants must have had symptoms for more than 4 weeks. The goal of the study is to measure biomarkers, identify new ones through clinical trials, and individualize and optimize treatment plans, which may or may not include COVID-19 post-market antivirals, vaccines, and medical care. It's essential to conduct thorough clinical trials to understand the long-term effects of COVID-19 and to develop personalized treatment plans for individuals experiencing long-haul symptoms. **Detailed Description:** We are planning a comprehensive study to understand and address the long-term effects of COVID-19. You aim to recruit 25 to 100 participants who have tested positive or clinically diagnosed with COVID-19, regardless of whether they have received treatment with COVID-19 post-market antivirals, vaccines, or medical care. The study will involve conducting intake eligibility assessments and providing available treatments for COVID-19 to address the core morbidities associated with long-haul COVID-19. Your plan also includes collecting data from diverse participants to define seven biomarker categories and create a prognosis indicator for COVID-19 symptoms using precision medicine methods. The focus will be on neurological and respiratory symptoms affecting quality of life, with a special emphasis on women and men who are prone to developing Post COVID-19 long-haul syndrome. Additionally, you have outlined a diversity plan to ensure representation from a wide range of demographics. It's clear that you are dedicated to addressing the impact of long-haul COVID-19 and are taking a comprehensive approach to understand and treat the persistent symptoms experienced by individuals post-COVID-19 infection. ### Conditions Module **Conditions:** - COVID-19, Long Haul ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** A parallel study is a type of clinical study in which two or more groups of participants receive different interventions. Participants are assigned to one of the treatment arms at the beginning of the trial and continue in that arm throughout the length of the trial. Assignment to a group usually is randomized. Study participants are only exposed to the treatment that is assigned to the particular study arm they are enrolled in. For example, a two-arm parallel assignment involves two groups of participants. One group receives drug A, and the other group receives drug B. So during the trial, participants in one group receive drug A "in parallel" to participants in the other group, who receive drug B. ##### Masking Info **Masking:** NONE **Masking Description:** Covid-19 Long Haul Preventative and Health Promotion Care Clinical Trial Acceleration Program. **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Unvaccinated individuals: Two doses of Moderna COVID-19 Vaccine (2023-2024 Formula) are administered. The second dose is administered 1 month after the first. Moderna COVID-19 Vaccine to include the 2023-2024 formula. The Moderna COVID-19 Vaccine (2023-2024 Formula) includes a monovalent (single) component that corresponds to the Omicron variant XBB.1.5 of SARS-CoV-2. The Moderna COVID-19 Vaccine (2023-2024 Formula) is authorized for all doses administered to individuals 6 months through 11 years of age to prevent COVID-19. The Moderna COVID-19 Vaccine, Bivalent is no longer authorized for use in the United States. Moderna COVID-19 Vaccine is a suspension for injection. A single dose is 0.25 mL. (3) History of a severe allergic reaction (e.g., anaphylaxis) to any component of Moderna COVID-19 Vaccine or following a previous dose of a Moderna COVID-19 vaccine. **Intervention Names:** - Drug: Ritonavir-Boosted Nirmatrelvir (Paxlovid) - Diagnostic Test: Physiological Evaluation - Biological: Moderna COVID-19 Vaccine - Behavioral: Biopsychological - Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling) - Genetic: Genetic (including gene transfer, stem cell and recombinant DNA) - Combination Product: Multidisciplinary approach **Label:** Moderna COVID-19 Vaccine **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** The COVID-19 Treatment Guidelines Panel (the Panel) recommends using nirmatrelvir 300 mg with ritonavir 100 mg (Paxlovid) orally (PO) twice daily for 5 days in nonhospitalized adults with mild to moderate COVID-19 who are at high risk of disease progression (). Treatment should be initiated as soon as possible and within 5 days of symptom onset. Ritonavir-boosted nirmatrelvir is available through an FDA EUA for the treatment of mild to moderate COVID-19 in nonhospitalized adolescents aged 12 to 17 years and weighing ≥40 kg.4 For recommendations on using ritonavir-boosted nirmatrelvir in nonhospitalized children with COVID-19. **Intervention Names:** - Drug: Ritonavir-Boosted Nirmatrelvir (Paxlovid) - Diagnostic Test: Physiological Evaluation - Biological: Moderna COVID-19 Vaccine - Behavioral: Biopsychological - Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling) - Genetic: Genetic (including gene transfer, stem cell and recombinant DNA) - Combination Product: Multidisciplinary approach **Label:** Ritonavir-Boosted Nirmatrelvir (Paxlovid) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Moderna COVID-19 Vaccine - Ritonavir-Boosted Nirmatrelvir (Paxlovid) **Description:** Participant Selection and Baseline Data Collection: 6 months * Longitudinal Observation and Intervention Implementation: 24 months * Data Analysis and Findings Dissemination: 6 months Evaluate methodological advantages and limitations of an international pharmacosurveillance system based on electronic health records (EHRs). Adverse outcome; Electronic health record; Health informatics; Medication adherence; Pharmacoepidemiology; Pharmacosurveillance; Risk assessment. **Name:** Ritonavir-Boosted Nirmatrelvir (Paxlovid) **Other Names:** - Phramacotherapies **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Moderna COVID-19 Vaccine - Ritonavir-Boosted Nirmatrelvir (Paxlovid) **Description:** Common Medical laboratory work-up, Cancer screening test, Biomarkers, tissue biopsy, blood specimen, diagnostic imagining, Sensitivity and Specificity, HIV PCR, Viral load ( antigen), CD4- T cell count, while implementation of social mediators of prevention, promotion studies and conceptual models and quality of care. **Name:** Physiological Evaluation **Other Names:** - Immunologic Evaluation **Type:** DIAGNOSTIC_TEST #### Intervention 3 **Arm Group Labels:** - Moderna COVID-19 Vaccine - Ritonavir-Boosted Nirmatrelvir (Paxlovid) **Description:** Single dose, 0.25 mL If previously vaccinated, ≥2 months after receipt of the last previous dose of COVID-19 vaccine **Name:** Moderna COVID-19 Vaccine **Type:** BIOLOGICAL #### Intervention 4 **Arm Group Labels:** - Moderna COVID-19 Vaccine - Ritonavir-Boosted Nirmatrelvir (Paxlovid) **Description:** Diagnosis of developmental milestones is considered a missing element in care measurement or a determining factor in disease signs and symptoms in chronic care management. Cognitive mapping, variations of survey, assessments, cancer counseling, leading to the realization that adherence requires a whole-person approach to delivering high-quality and cost-effective care. the project aims to offer opportunities to individuals from diverse backgrounds, including those underrepresented in biomedical research, in an inclusive environment in which all trainees can contribute. The proposed training activities are designed to improve the research skills of the participants and encourage them to pursue further training and careers in biomedical and/or social/behavioral research. **Name:** Biopsychological **Type:** BEHAVIORAL #### Intervention 5 **Arm Group Labels:** - Moderna COVID-19 Vaccine - Ritonavir-Boosted Nirmatrelvir (Paxlovid) **Description:** Diagnosis of developmental milestones is considered a missing element in care measurement or a determining factor in disease signs and symptoms in chronic care management. Cognitive mapping, variations of survey, assessments, cancer counseling, leading to the realization that adherence requires a whole-person approach to delivering high-quality and cost-effective care. the project aims to offer opportunities to individuals from diverse backgrounds, including those underrepresented in biomedical research, in an inclusive environment in which all trainees can contribute. The proposed training activities are designed to improve the research skills of the participants and encourage them to pursue further training and careers in biomedical and/or social/behavioral research. **Name:** Behavioral (e.g., Psychotherapy, Lifestyle Counseling) **Other Names:** - Biopsychological **Type:** BEHAVIORAL #### Intervention 6 **Arm Group Labels:** - Moderna COVID-19 Vaccine - Ritonavir-Boosted Nirmatrelvir (Paxlovid) **Description:** Full genome sequencing, complete genome sequencing, or entire genome sequencing, is the process of determining the entirety, or nearly the entirety, of the DNA sequence of an organism's genome at a single time to address the intersection of genomics and health disparities, recognizing that genetic variations can contribute to health disparities in several ways. Understanding these genetic contributions to health disparities is crucial for developing targeted interventions and personalized healthcare strategies that can help address these disparities. genetics, epidemiology, public health, and social sciences, the study aims to shed light on the complex interplay between genomics and health equity. To evaluate cellular errors and the effects of myocardial DNA, you may need to consider tests such as DNA sequence. **Name:** Genetic (including gene transfer, stem cell and recombinant DNA) **Other Names:** - Whole Genome Sequence **Type:** GENETIC #### Intervention 7 **Arm Group Labels:** - Moderna COVID-19 Vaccine - Ritonavir-Boosted Nirmatrelvir (Paxlovid) **Description:** The aim of utilizes psychology-applied science and science in nursing frameworks to address health disparities and promote health and wellness across the health span to improve patient population outcomes, evaluate cost-effectiveness, and patient health literacy competencies. The experimental framework of a compilation of the bio-psychosocial model, Eric Erickson developmental stages, AI/AML, and cognitive learning theories address system decision making factors, for sound decision making and behavioral change cognitive behavioral therapies protocol segmentation demographic and urban areas affected by social-economic access to healthcare and related ethical stance of United States healthcare policy developmental outlines. Biology plays a role in the content of development stages, and the great debate of nurture vs. nature sets the foundation for addressing the psychosocial approach to healthcare integration as an applied science model for strengthening primary services and improving **Name:** Multidisciplinary approach **Type:** COMBINATION_PRODUCT ### Outcomes Module #### Other Outcomes **Description:** The research will delve into the impact of epigenetic factors on health outcomes, particularly in marginalized communities. By examining genomics and health equity, the study seeks to identify disparities in the prevalence and treatment of epigenetic conditions among different population groups. The goal is to develop targeted interventions and metrics to improve health outcomes and access to genomic interventions for all individuals, irrespective of their background or socioeconomic status. **Measure:** Patient Engagement **Time Frame:** - Participant Selection and Baseline Data Collection: 36 months - Longitudinal Observation and Intervention Implementation: 24 months - Data Analysis and Findings Dissemination: 36 months #### Primary Outcomes **Description:** Well-Konnect Biopsychosoical Framework and assessment tool (WKBF tool) compared to the APA biopsychological assessment. Health literacy surveillance care program evaluation tool aims to lay the groundwork for a more inclusive and equitable approach to leveraging genomic data and interventions to improve health outcomes for all individuals. **Measure:** Adherence **Time Frame:** - Participant Selection and Baseline Data Collection: 36 months - Longitudinal Observation and Intervention Implementation: 24 months - Data Analysis and Findings Dissemination: 36 months #### Secondary Outcomes **Description:** Evaluate methodological advantages and limitations of an international pharmacosurveillance system based on electronic health records (EHRs). Adverse outcome; Electronic health record; Health informatics; Medication adherence; Pharmacoepidemiology; Pharmacosurveillance; Risk assessment. **Measure:** Pharmaco surveillance **Time Frame:** - Participant Selection and Baseline Data Collection: 36 months - Longitudinal Observation and Intervention Implementation: 24 months - Data Analysis and Findings Dissemination: 36 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Inclusion of Men, Women, and Minorities * Participants must be at least 18 years old. * Participants must have a positive COVID-19 diagnosis or clinical diagnosis of COVID-19 * Participants must have experienced persistent symptoms after recovering from the acute phase of the illness. * Participants must be willing to provide informed consent to participate in the study. * Participants must be able to communicate effectively in English or have a translator available. * Participants must be able to attend follow-up appointments as required by the study protocol. * Participants must not have any medical conditions or take any medications that could interfere with the study results. Exclusion Criteria: * \>18 years of age * Medical History of Myocarditis * Medical History of Pericarditis * Medical History of Severe renal impairment (eGFR \<30 mL/min). **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bethesda **Country:** United States **Facility:** NIH Clinical Center **State:** Maryland **Zip:** 20892 #### Overall Officials **Official 1:** **Affiliation:** The National Institute of Health All of Us Research Program At Well-Konnect Healthcare Services and Research Center **Name:** Kawana J Williams, Ph.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Authorization for access to the registered and controlled data tiers will be user based, rather than project-based. Authorized users will receive a "data passport." A data passport is required for access to the registered and controlled data tiers and to set up workspaces to carry out research projects . As one of the first steps in initiating an All of Us registered and controlled tier project and setting up a workspace, users will be required to submit a description of their project. These descriptions will be made public and searchable for auditing purposes to facilitate public engagement. **Description:** No participant count of 1 to 20 can be published or distributed directly (a count of 0 is permitted); and No data or statistics can be reported that allow a participant count of 1 to 20 to be derived from other reported cells or information, including in text, tables, or figures. **Info Types:** - CSR - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** 10 years ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011024 - Term: Pneumonia, Viral - ID: D000011014 - Term: Pneumonia - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000014777 - Term: Virus Diseases - ID: D000018352 - Term: Coronavirus Infections - ID: D000003333 - Term: Coronaviridae Infections - ID: D000030341 - Term: Nidovirales Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M2561 - Name: COVID-19 - Relevance: HIGH - As Found: COVID-19 - ID: M13904 - Name: Pneumonia - Relevance: LOW - As Found: Unknown - ID: M13914 - Name: Pneumonia, Viral - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M20490 - Name: Coronavirus Infections - Relevance: LOW - As Found: Unknown - ID: M6555 - Name: Coronaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M23685 - Name: Nidovirales Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000086382 - Term: COVID-19 ### Intervention Browse Module - Ancestors - ID: D000017320 - Term: HIV Protease Inhibitors - ID: D000084762 - Term: Viral Protease Inhibitors - ID: D000011480 - Term: Protease Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000019380 - Term: Anti-HIV Agents - ID: D000044966 - Term: Anti-Retroviral Agents - ID: D000000998 - Term: Antiviral Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000065692 - Term: Cytochrome P-450 CYP3A Inhibitors - ID: D000065607 - Term: Cytochrome P-450 Enzyme Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21394 - Name: Ritonavir - Relevance: HIGH - As Found: 6 weeks - ID: M254018 - Name: Nirmatrelvir - Relevance: HIGH - As Found: IPT - ID: M17360 - Name: Vaccines - Relevance: LOW - As Found: Unknown - ID: M251802 - Name: Imidacloprid - Relevance: LOW - As Found: Unknown - ID: M266470 - Name: Nirmatrelvir and ritonavir drug combination - Relevance: HIGH - As Found: High Altitude - ID: M19609 - Name: HIV Protease Inhibitors - Relevance: LOW - As Found: Unknown - ID: M14343 - Name: Protease Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M21350 - Name: Anti-HIV Agents - Relevance: LOW - As Found: Unknown - ID: M25428 - Name: Anti-Retroviral Agents - Relevance: LOW - As Found: Unknown - ID: M4314 - Name: Antiviral Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M30564 - Name: Cytochrome P-450 CYP3A Inhibitors - Relevance: LOW - As Found: Unknown - ID: M30537 - Name: Cytochrome P-450 Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000019438 - Term: Ritonavir - ID: C000718217 - Term: Nirmatrelvir - ID: C000719967 - Term: Nirmatrelvir and ritonavir drug combination ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441942 **Acronym:** ACS GEDI **Brief Title:** Prospective Multicenter Registry of Gender, Diversity and Inclusion (GEDI) of Women With Acute Coronary Syndrome **Official Title:** Creation of a Prospective Multicenter Registry of Gender, Diversity and Inclusion (GEDI) in Phenotypic and Genetic Characterization of Acute Coronary Syndrome. #### Organization Study ID Info **ID:** PNRR-MCNT2-2023-12377431 #### Organization **Class:** OTHER **Full Name:** IRCCS San Raffaele ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-06 **Type:** ESTIMATED **Last Update Submit Date:** 2024-06-05 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-01 **Type:** ESTIMATED **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Federico II University #### Lead Sponsor **Class:** OTHER **Name:** IRCCS San Raffaele #### Responsible Party **Investigator Affiliation:** IRCCS San Raffaele **Investigator Full Name:** Chieffo Alaide **Investigator Title:** Prof. M.D. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Create a multicenter prospective registry that collects information from women affected by acute coronary syndrome (ACS). This registry aims to understand the diversity in the presentation of women with ACS. It proposes to conduct a thorough characterization of the women involved in the study through genetic, biochemical, and molecular analysis.This approach aims to identify any differences in the characteristics of women with ACS and to identify disease subtypes that may influence treatment options and clinical outcomes. **Detailed Description:** Create a multicenter prospective registry that collects information from women affected by acute coronary syndrome (ACS) from a wide range of cultural and ethnic backgrounds distributed across various Italian regions. This registry aims to understand the diversity in the presentation of women with ACS in Italy, providing valuable data for a better understanding of the disease. Additionally, it proposes to conduct a thorough characterization of the women involved in the study through genetic, biochemical, and molecular analysis. This analysis will be stratified by age and the etiology of coronary artery disease, distinguishing between obstructive and non-obstructive coronary artery disease. Specific aims of this proposal are: 1. To create a multicenter prospective registry including women with ACS from a variety of cultural and ethnical backgrounds in different Italian regions 2. To deeply characterize women with ACS through clinical, imaging, genetic, biochemical, and molecular phenotyping stratifying for age, etiology (obstructive vs non-obstructive CAD) and diversity. 3. To assess socioeconomic status, health literacy and awareness of risk factors among enrolled patients. ### Conditions Module **Conditions:** - Acute Coronary Syndrome - Gender - Genetic Predisposition **Keywords:** - ACS - GEDI - Genetic - DNA - mRNA - Proteomic - Metabolomic ### Design Module #### Bio Spec **Description:** DNA, mRNA, proteomic and metabolomic. **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 12 Months ### Arms Interventions Module #### Arm Group 1 **Description:** Female patient presenting with ACS (age \>/= 18) **Label:** Case ### Outcomes Module #### Primary Outcomes **Description:** The aim will be to create a prospective multicenter registry of gender, diversity and inclusion (GEDI) of women with Acute Coronary Syndrome **Measure:** Multicentric Registry **Time Frame:** 12 months of follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Women \>/= 18 years with ACS (STEMI, NSTEMI or Unstable Angina). Exclusion Criteria: * age \< 18 years and/or unwillingness to sign informed consent and/or unwillingness to make follow-up visits **Gender Based:** True **Gender Description:** Female patient \>/= 18 **Maximum Age:** 100 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study will include female patients presenting with ACS (according to ESC guidelines) ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Alaide Chieffo, MD **Phone:** +39/02/2643.7331 **Phone Ext:** 7362 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Vega Rusconi **Phone:** 0226439327 **Role:** CONTACT #### Locations **Location 1:** **City:** Milano **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Alaide Chieffo, Prof. M.D. - **Phone:** 02 26434840 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Vega Rusconi - **Phone:** 0226439327 - **Role:** CONTACT **Country:** Italy **Facility:** IRCCS San Raffaele Hospital **State:** Italy Milan **Zip:** 20132 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Weiss AM. Cardiovascular disease in women. Prim Care. 2009 Mar;36(1):73-102, viii. doi: 10.1016/j.pop.2008.10.012. **PMID:** 19231603 **Citation:** Vogel B, Acevedo M, Appelman Y, Bairey Merz CN, Chieffo A, Figtree GA, Guerrero M, Kunadian V, Lam CSP, Maas AHEM, Mihailidou AS, Olszanecka A, Poole JE, Saldarriaga C, Saw J, Zuhlke L, Mehran R. The Lancet women and cardiovascular disease Commission: reducing the global burden by 2030. Lancet. 2021 Jun 19;397(10292):2385-2438. doi: 10.1016/S0140-6736(21)00684-X. Epub 2021 May 16. **PMID:** 34010613 **Citation:** Graham G. Acute Coronary Syndromes in Women: Recent Treatment Trends and Outcomes. Clin Med Insights Cardiol. 2016 Feb 8;10:1-10. doi: 10.4137/CMC.S37145. eCollection 2016. **PMID:** 26884685 **Citation:** Vaccarino V, Parsons L, Every NR, Barron HV, Krumholz HM. Sex-based differences in early mortality after myocardial infarction. National Registry of Myocardial Infarction 2 Participants. N Engl J Med. 1999 Jul 22;341(4):217-25. doi: 10.1056/NEJM199907223410401. **PMID:** 10413733 **Citation:** Udell JA, Fonarow GC, Maddox TM, Cannon CP, Frank Peacock W, Laskey WK, Grau-Sepulveda MV, Smith EE, Hernandez AF, Peterson ED, Bhatt DL; Get With The Guidelines Steering Committee and Investigators. Sustained sex-based treatment differences in acute coronary syndrome care: Insights from the American Heart Association Get With The Guidelines Coronary Artery Disease Registry. Clin Cardiol. 2018 Jun;41(6):758-768. doi: 10.1002/clc.22938. Epub 2018 May 11. **PMID:** 29521450 **Citation:** Bavishi C, Bangalore S, Patel D, Chatterjee S, Trivedi V, Tamis-Holland JE. Short and long-term mortality in women and men undergoing primary angioplasty: A comprehensive meta-analysis. Int J Cardiol. 2015 Nov 1;198:123-30. doi: 10.1016/j.ijcard.2015.07.001. Epub 2015 Jul 4. **PMID:** 26163903 **Citation:** Renda G, Patti G, Lang IM, Siller-Matula JM, Hylek EM, Ambrosio G, Haas S, De Caterina R; Working Group on Thrombosis of the Italian Society of Cardiology. Thrombotic and hemorrhagic burden in women: Gender-related issues in the response to antithrombotic therapies. Int J Cardiol. 2019 Jul 1;286:198-207. doi: 10.1016/j.ijcard.2019.02.004. Epub 2019 Feb 8. **PMID:** 30777407 **Citation:** Smilowitz NR, Mahajan AM, Roe MT, Hellkamp AS, Chiswell K, Gulati M, Reynolds HR. Mortality of Myocardial Infarction by Sex, Age, and Obstructive Coronary Artery Disease Status in the ACTION Registry-GWTG (Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With the Guidelines). Circ Cardiovasc Qual Outcomes. 2017 Dec;10(12):e003443. doi: 10.1161/CIRCOUTCOMES.116.003443. **PMID:** 29246884 **Citation:** Wechkunanukul K, Grantham H, Damarell R, Clark RA. The association between ethnicity and delay in seeking medical care for chest pain: a systematic review. JBI Database System Rev Implement Rep. 2016 Jul;14(7):208-35. doi: 10.11124/JBISRIR-2016-003012. **PMID:** 27532797 **Citation:** Bonaccorsi G, Grazzini M, Pieri L, Santomauro F, Ciancio M, Lorini C. Assessment of Health Literacy and validation of single-item literacy screener (SILS) in a sample of Italian people. Ann Ist Super Sanita. 2017 Jul-Sep;53(3):205-212. doi: 10.4415/ANN_17_03_05. **PMID:** 28956799 **Citation:** Parker RM, Baker DW, Williams MV, Nurss JR. The test of functional health literacy in adults: a new instrument for measuring patients' literacy skills. J Gen Intern Med. 1995 Oct;10(10):537-41. doi: 10.1007/BF02640361. **PMID:** 8576769 **Citation:** Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available. Erratum In: Eur Heart J. 2024 Apr 1;45(13):1145. **PMID:** 37622654 **Citation:** Agewall S, Beltrame JF, Reynolds HR, Niessner A, Rosano G, Caforio AL, De Caterina R, Zimarino M, Roffi M, Kjeldsen K, Atar D, Kaski JC, Sechtem U, Tornvall P; WG on Cardiovascular Pharmacotherapy. ESC working group position paper on myocardial infarction with non-obstructive coronary arteries. Eur Heart J. 2017 Jan 14;38(3):143-153. doi: 10.1093/eurheartj/ehw149. No abstract available. **PMID:** 28158518 **Citation:** Collet JP, Thiele H, Barbato E, Barthelemy O, Bauersachs J, Bhatt DL, Dendale P, Dorobantu M, Edvardsen T, Folliguet T, Gale CP, Gilard M, Jobs A, Juni P, Lambrinou E, Lewis BS, Mehilli J, Meliga E, Merkely B, Mueller C, Roffi M, Rutten FH, Sibbing D, Siontis GCM; ESC Scientific Document Group. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2021 Apr 7;42(14):1289-1367. doi: 10.1093/eurheartj/ehaa575. No abstract available. Erratum In: Eur Heart J. 2021 May 14;42(19):1908. Eur Heart J. 2021 May 14;42(19):1925. Eur Heart J. 2021 May 13;: Eur Heart J. 2024 Feb 1;45(5):404-405. **PMID:** 32860058 **Citation:** Sousa-Uva M, Neumann FJ, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur J Cardiothorac Surg. 2019 Jan 1;55(1):4-90. doi: 10.1093/ejcts/ezy289. No abstract available. **PMID:** 30165632 #### See Also Links **Label:** Related Info **URL:** https://www.un.org/sustainabledevelopment/health/ **Label:** Related Info **URL:** https://healthliteracy.bu.edu/documents/13/Italian%20STOFHLA%20-%20last.pdf **Label:** Related Info **URL:** https://euroqol.org/information-and-support/euroqol-instruments/eq-5d-5l/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000017202 - Term: Myocardial Ischemia - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000004198 - Term: Disease Susceptibility - ID: D000020969 - Term: Disease Attributes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M21875 - Name: Genetic Predisposition to Disease - Relevance: HIGH - As Found: Genetic Predisposition - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M27545 - Name: Acute Coronary Syndrome - Relevance: HIGH - As Found: Acute Coronary Syndrome - ID: M7380 - Name: Disease Susceptibility - Relevance: LOW - As Found: Unknown - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M6546 - Name: Coronary Artery Disease - Relevance: LOW - As Found: Unknown - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000054058 - Term: Acute Coronary Syndrome - ID: D000013577 - Term: Syndrome - ID: D000020022 - Term: Genetic Predisposition to Disease ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441929 **Acronym:** 1/2024 **Brief Title:** Pregnancy Ultrasound Satisfaction Scoring System **Official Title:** How Difficult a Fetal Ultrasound Can be: Time for a Dedicated Classification System #### Organization Study ID Info **ID:** 1/2024 #### Organization **Class:** OTHER **Full Name:** Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis ### Status Module #### Completion Date **Date:** 2024-03-28 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-03-01 **Type:** ACTUAL #### Start Date **Date:** 2023-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis #### Responsible Party **Investigator Affiliation:** University of Bari Aldo Moro **Investigator Full Name:** Roberta Zupo **Investigator Title:** PhD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Sonographic imaging stands as the mainstay of fetal anatomical investigation and the primary screening tool for structural abnormalities early in pregnancy. This study aimed to evaluate the occurrence and effect of a cluster of maternal features on sonographic image quality and operator satisfaction. **Detailed Description:** This was a cross-sectional, single-center observational study of ultrasound scans performed on singleton pregnant women who underwent ultrasound imaging at 11-14 weeks and 19-21 weeks gestation. From March 2023 to March 2024, a convenience cohort of pregnant women who presented for prenatal care at the Fetal Medicine and Prenatal Diagnosis Unit of "Di Venere" Hospital in Bari (Apulia, Southern Italy) and the Obstetrics and Gynecology Unit of Vito Fazzi Hospital in Lecce (Apulia, Southern Italy) to receive routine gestational ultrasound was recruited for the present study. The inclusion criteria were singleton pregnancy and the presence of one or more of the risk factors widely described in the literature as limiting features, i.e., excess weight (BMI\>24.9 Kg/m2), retroverted uterus, the presence of myomas, a previous abdominal surgery, and a limited echo absorption. No exclusion criteria related to women's gestational age or ethnicity were applied. ### Conditions Module **Conditions:** - Ultrasound Satisfaction in Pregnant Women ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 500 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Operator ultrasound satisfaction, rating as "low", "good", or "very good" **Measure:** Operator ultrasound satisfaction **Time Frame:** baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Pregnant women presenting one or more of the risk factors widely described in the literature as limiting features, i.e., excess weight (BMI\>24.9 Kg/m2), retroverted uterus, the presence of myomas, previous abdominal surgery, and limited echo absorption. Exclusion Criteria: * No limiting factors described above * No pregnant women **Gender Based:** True **Gender Description:** Pregnant women presenting one or more of the risk factors widely described in the literature as limiting features, i.e., excess weight (BMI\>24.9 Kg/m2), retroverted uterus, the presence of myomas, previous abdominal surgery, and limited echo absorption. **Healthy Volunteers:** True **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** A cohort of pregnant women who underwent ultrasound imaging at 11-14 weeks and 19-21 weeks gestation ### Contacts Locations Module #### Locations **Location 1:** **City:** Bari **Country:** Italy **Facility:** University of Bari Aldo Moro ### 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:** NCT06441916 **Brief Title:** Bioequivalence Study of Dabigatran Etexilate Capsules 150 mg in Healthy Thai Volunteers Under Fasting Conditions **Official Title:** A Single Dose, Randomized, Open-label, Two-treatment, Four-period, Two-sequence, Replicate Crossover Bioequivalence Study of Generic Dabigatran Etexilate Capsules 150 mg and Reference Product (Pradaxa®) in Healthy Thai Volunteers Under Fasting Conditions and Under Pre-treatment With a Proton Pump Inhibitor #### Organization Study ID Info **ID:** BE24-008 #### Organization **Class:** NETWORK **Full Name:** International Bio service ### Status Module #### Completion Date **Date:** 2024-11-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-06 **Type:** ESTIMATED **Last Update Submit Date:** 2024-06-04 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-10-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-25 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-26 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** NETWORK **Name:** International Bio service #### 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 bioequivalence of Dabigatran Etexilate Capsules 150 mg to Boehringer Ingelheim's Pradaxa® will be assessed by a statistical comparison of various pharmacokinetic parameters derived from the plasma concentration-time curves of free dabigatran and total dabigatran. **Detailed Description:** Bioequivalence study is a research study that needs to compare the rate and extent to which the active substance or active moiety is absorbed from a pharmaceutical dosage form between innovator or reference product and test product when given in healthy subjects at the same dose and strength. The acceptance criteria in bioequivalence study will be done by comparing the pharmacokinetic parameters including maximal plasma concentration (Cmax) time at which the maximum plasma concentration occurs (Tmax) and area under the plasma concentration curve (AUC) either area under the plasma concentration curve from administration to last observed concentration at time t (AUC0-tlast) or area under the plasma concentration curve extrapolated to infinite time (AUC0-∞). Those parameters should be calculated only from the plasma concentration and time curve but cannot use other data obtained from in vitro study. By this reason, it is necessary to conduct the study in healthy subjects ### Conditions Module **Conditions:** - Healthy Volunteer - Dabigatran - Bioequivalence Study ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Each capsule contains Dabigatran Etexilate 150 mg **Intervention Names:** - Drug: Dabigatran Etexilate Capsules 150 mg **Label:** Dabigatran Etexilate Capsules 150 mg **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Dabigatran Etexilate **Intervention Names:** - Drug: Dabigatran Etexilate Capsules 150 mg **Label:** Pradaxa® **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Dabigatran Etexilate Capsules 150 mg - Pradaxa® **Description:** Dabigatran Etexilate **Name:** Dabigatran Etexilate Capsules 150 mg **Other Names:** - Dabigatran **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Maximum measured plasma concentration over the time span specified. **Measure:** Peak Plasma Concentration (Cmax) of Dabigatran **Time Frame:** Through 48 Hours Post Dose **Description:** The area under the plasma concentration versus time curve. **Measure:** Plasma Area Under the Curve AUC(0 to 48hr, AUC0-∞ **Time Frame:** Through 48 Hours Post Dose ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy Thai male or female subjects between the ages of 18 to 55 years. Subject must meet age requirements at the time of signing the initial informed consent and at the dosing day in Period 1. * Body mass index between 18.5 to 30.0 kg/m2 * Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study * Non-smoker and non-consumer of nicotine containing products. Non-smoker or non-consumer of nicotine containing products means any subject who has never smoked/consumed or stopped for at least 90 days. * Non-pregnant woman (negative pregnancy test) and not currently breast feeding. * Female subjects abstain from either hormonal methods of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to check-in in Period 1. Injectable contraceptives e.g. Depo-Provera® will be discontinued at least 6 months prior to check-in in Period 1. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to check-in in Period 1 until 7 days after the end of study in Period 4. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to check-in in Period 1: * Postmenopausal for at least 1 year or * Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months * Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after check-in in Period 1 until 7 days after the end of study in Period 4. * Able to understand and voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study. * Adequate venous access in both arms for the collection of a number of samples during the study. Exclusion Criteria: * History of hypersensitivity to dabigatran or dabigatran etexilate or to any of the excipients of product * History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hyper-/hypothyroid, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper-/hypotension), psychiatric (e.g. depression), neurologic (e.g. convulsant), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness. Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19. * History about administration of COVID-19 vaccine within 30 days prior to check-in in each Period. * Have eGFR (CKD-EPI) \< 50 mL/min/1.73 m2 based on serum creatinine results, at the screening laboratory test or during enrollment. * History or evidence of haemorrhagic manifestations, patients with a bleeding diathesis or patients with spontaneous or pharmacological impairment of haemostasis. * History or evidence of organ lesions at risk of clinically significant bleeding, including haemorrhagic stroke within the last 6 months. * History or evidence of surgery for prosthetic heart valve replacement. * History or evidence of surgery for knee or hip replacement. * History or evidence of venous thromboembolic events, deep vein thrombosis or pulmonary embolism. * History or evidence of stroke. * History or evidence of atrial fibrillation. * History of sensitivity to heparin or heparin-induced thrombocytopenia. * Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy. * History of diarrhea or vomiting within 24 hours prior to check-in in each period. * History of problems with swallowing tablet or capsule. * History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine). * 12-lead ECG demonstrating QTc \> 450 msec, a QRS interval \> 120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG will be repeated two more times and the average of the three QTc or QRS values will be used to determine the subject's eligibility. * Investigation with blood sample shows positive test for HBsAg. * Abnormal liver function, ≥1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test. History or evidence of alcoholism or harmful use of alcohol (less than 2 years) i.e., alcohol consumption of more than 14 standard drinks per week for men and 7 standard drinks per week for women (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 mL of 40% distilled spirits, such as rum, whisky, brandy etc.). * History or evidence of alcohol consumption or alcohol-containing products and cannot abstain for at least 48 hours prior to check-in and continued for entire duration of the study or alcohol breath test shows positive result In case of alcohol breath test result represents the alcohol concentration range of 1 - 10 mg% BAC and the physician carefully considers that the value came from other reasons, not from the alcohol drinking behavior of subjects, the test will be repeated two times separately, not more than 10 minutes. The result of the last time should be used for subject's eligibility which must be 0 mg%BAC. * History or evidence of habitual consume of any caffeine- or xanthine-containing products e.g. tea, coffee, chocolate, colas etc. and cannot abstain for at least 72 hours prior to check-in and continued for entire duration of the study. * Consume or drink juice of grapefruit or orange or pomelo or its supplement/ containing products and cannot abstain for at least 7 days prior to check-in and continued for entire duration of the study. * Use of prescription or nonprescription drugs (e.g. paracetamol, amiodarone, verapamil, quinidine, ketoconazole, dronedarone, ticagrelor, clarithromycin, other anticoagulants, NSAIDs, selective serotonin reuptake inhibitors, selective serotonin norepinephrine reuptake inhibitors, fibrinolytic agents and etc.), herbal medications or supplements (e.g. St. John's wort), vitamins or mineral (e.g. iron) or dietary supplements within 14 days prior to check-in in Period 1 and continued for entire duration of the study * Participated in other clinical trials within 90 days prior to check-in in Period 1 (except for the subjects who drop out or withdrawn from the previous study prior to Period 1 dosing) or still participates in the clinical trial or participates in other clinical trials during enrollment in this study * Blood donation or blood loss ≥ 1 unit (1 unit is equal to 350-450 mL of blood) within 90 days prior to check-in in Period 1 or during enrollment. * Subjects with poor venous access or intolerant to venipuncture. * Unwilling or unable to comply with schedule visit, treatment plan and other study procedures until end of study. * Inability to communicate well (i.e. language problem, poor mental development, psychiatric illness or poor cerebral function) that may impair the ability to provide written informed consent or cooperate with clinical team. **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Thanaporn Wongyai, M.Sc.Pharm **Phone:** 024415211 **Phone Ext:** 220 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Paweena Boonprakong, B.Sc. **Phone:** 024415211 **Phone Ext:** 220 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** International Bio Service Co., Ltd. **Name:** Porranee Puranajoti, Ph. D **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000000991 - Term: Antithrombins - ID: D000015842 - Term: Serine Proteinase Inhibitors - ID: D000011480 - Term: Protease Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000925 - Term: Anticoagulants ### Intervention Browse Module - Browse Branches - Abbrev: AnCoag - Name: Anticoagulants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M490 - Name: Dabigatran - Relevance: HIGH - As Found: Direct current - ID: M27630 - Name: Proton Pump Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4307 - Name: Antithrombins - Relevance: LOW - As Found: Unknown - ID: M4306 - Name: Antithrombin III - Relevance: LOW - As Found: Unknown - ID: M14343 - Name: Protease Inhibitors - Relevance: LOW - As Found: Unknown - ID: M18391 - Name: Serine Proteinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M19609 - Name: HIV Protease Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4244 - Name: Anticoagulants - Relevance: LOW - As Found: Unknown - ID: T18 - Name: Serine - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000069604 - Term: Dabigatran ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441903 **Acronym:** USPEC **Brief Title:** Connective Tissue of Pectoralis Major Muscle: Anatomical Study **Official Title:** Connective Tissue of Pectoralis Major Muscle: Anatomical Study #### Organization Study ID Info **ID:** 2024/02 #### Organization **Class:** OTHER **Full Name:** CMC Ambroise Paré ### Status Module #### Completion Date **Date:** 2025-01-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-03 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-01-20 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-06-03 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** CMC Ambroise Paré #### 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 delto-pectoral tendon (DPT) is a new tendon recently identified. It completes the insertion of the pectoralis major and perfectly explains the different injuries encountered. The objective of this observational study is to visualize this new tendon, the DPT, using ultrasound, to measure it, to characterize its role in the overall architecture of the pectoralis major muscle and to analyze its relationship with its main tendon and the anterior and posterior laminae. ### Conditions Module **Conditions:** - Pectoralis Muscle **Keywords:** - Anterior Deltoid Tendon - Anterior Lamina Pectoralis Major - Posterior Lamina Pectoralis Major - Pectoralis Major Tendon - Ultrasound - Deep Fascia Pectoralis Major - Delto Pectoral Tendon ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Ultrasound **Label:** Adults with no history of pectoralis major ### Interventions #### Intervention 1 **Arm Group Labels:** - Adults with no history of pectoralis major **Description:** Through systematic ultrasound visualization of the pectoralis major muscle, we seek to directly visualize and characterize the different intra- and extra-muscular connective structures of the muscle - Delto Pectoral Tendon (DPT) , Distal Pectoralis Major Tendon (PMT), Anterior Deltoid Tendon (ADT), Anterior Pretendinous Lamina of the Pectoralis Major (ALPM), Posterior Pretendinous Lamina of the Pectoralis Major (PLPM) and Deep Fascia of the Pectoral Major (DFPM) - constituting its connective skeleton, with particular attention to its distal portion near the humerus and on the search for this DPT tendon. **Name:** Ultrasound **Other Names:** - Shoulder ultrasound with focus on pectoralis major muscle connective skeleton and distal tendon **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Ultrasound visualization of Delto Pectoral Tendon **Time Frame:** 20 minutes #### Secondary Outcomes **Measure:** Measurement of DPT by ultrasonography (height, length and thickness in mm) **Time Frame:** 20 minutes **Measure:** Measurement of ADT by ultrasonography (height, length and thickness in mm) **Time Frame:** 20 minutes **Measure:** Measurement of PMT by ultrasonography (height, length and thickness in mm) **Time Frame:** 20 minutes **Measure:** Measurement of the distances in mm between the PMT humeral insertion and the different connective structures: ADT, DPT, ALPM, PLPM and DFPM **Time Frame:** 20 minutes **Measure:** Ultrasound visualization of the clavicular and sternal portions of the pectoralis major. **Time Frame:** 20 minutes ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patient \> 18 years, * Consultation for a musculoskeletal pathology of the upper limb Exclusion Criteria: * History of pathology of the pectoralis major or of the distal tendon of the pectoralis major * Pregnant or breastfeeding women * Patient under protection of the adults (guardianship, curators or safeguard of justice) * Unable to understand * Opposition by the patient **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adults with no history of pectoralis major and consulting for a musculoskeletal pathology of the upper limb ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Renaud GUIU, MD **Phone:** 0146415079 **Phone Ext:** +33 **Role:** CONTACT #### Locations **Location 1:** **City:** Neuilly-sur-Seine **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Renaud GUIU, MD - **Phone:** 0146415079 - **Phone Ext:** +33 - **Role:** CONTACT **Country:** France **Facility:** Ambroise Paré - Hartmann Private Hospital Group **State:** Ile De France **Zip:** 92200 ### 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:** NCT06441890 **Acronym:** BRE-10 **Brief Title:** BRE-10: Biomarker Optimization of Neoadjuvant Therapy in Breast Cancer **Official Title:** BRE-10: BIomarker OptimizatioN of NeOadjuVAnt Therapy in BrEast Cancer: The INNOVATE Trial #### Organization Study ID Info **ID:** 2023-1384 #### Organization **Class:** OTHER **Full Name:** University of Illinois at Chicago ### Status Module #### Completion Date **Date:** 2028-06 **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:** 2028-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Illinois at Chicago #### Responsible Party **Investigator Affiliation:** University of Illinois at Chicago **Investigator Full Name:** Kent F. Hoskins, MD **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Adult men and women with early-stage, IHC/FISH-defined HER2-positive breast cancer will have a MammaPrint®/BluePrint® assay performed on the diagnostic biopsy specimen, ordered by the treating Oncologist as standard care **Detailed Description:** Adult men and women with early-stage, IHC/FISH-defined HER2-positive breast cancer will have a MammaPrint®/BluePrint® assay performed on the diagnostic biopsy specimen, ordered by the treating Oncologist as standard care. Patients whose tumors have a HER2-enriched molecular subtype on the MammaPrint®/BluePrint® assay and are recommended for neoadjuvant chemotherapy by their treating Oncologist will be recruited for study enrollment ### Conditions Module **Conditions:** - Breast Cancer - HER2-positive Breast Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 28 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** One of the following Taxane options below per physician's choice * Paclitaxel 80mg/m2 IV D1, 8, 15 Q21 days * Nab-paclitaxel1 125mg/m2 IV D1, 8, 15 Q21 days * Docetaxel1 75mg/m2 IV D1 Q-21 days * Trastuzumab2 8mg/kg loading, then 6mg/kg IV/SQ D1 Q21 days * Pertuzumab2 840 mg loading, then 420mg IV/SQ D1 Q21 days * 1 may be substituted for paclitaxel for patients intolerant to paclitaxel or the steroid premed regimen, or at investigator discretion * 2 Pertuzumab, trastuzumab, and hyaluronidase injection for subcutaneous use may be substituted with dose per package insert **Intervention Names:** - Drug: Paclitaxel - Drug: Nab-paclitaxel - Drug: Docetaxel - Drug: Trastuzumab - Drug: Pertuzumab **Label:** Single Treatment Arm **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Single Treatment Arm **Description:** 80mg/m2 IV D1, 8, 15 **Name:** Paclitaxel **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Single Treatment Arm **Description:** 125mg/m2 IV D1, 8, 15 **Name:** Nab-paclitaxel **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Single Treatment Arm **Description:** 75mg/m2 IV D1 **Name:** Docetaxel **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Single Treatment Arm **Description:** 8mg/kg loading, then 6mg/kg IV/SQ D1 **Name:** Trastuzumab **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - Single Treatment Arm **Description:** 840 mg loading, then 420mg IV/SQ D1 **Name:** Pertuzumab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** This is defined as the absence of any residual invasive carcinomancer on hematoxylin and eosin evaluation of the resected breast specimen and any resected lymph node tissue **Measure:** Number of participants that have a pathological complete response (pCR) **Time Frame:** 16 weeks #### Secondary Outcomes **Description:** Number of participants having good outcome versus low outcomes. High score means worse health outcomes and low score means better health outcomes **Measure:** Participant outcomes using the Quality of Life (QOL) and EORTC QOL-C30 questionnaires **Time Frame:** Baseline **Description:** Number of participants having good outcome versus low outcomes. High score means worse health outcomes and low score means better health outcomes **Measure:** Participant outcomes using the Quality of Life (QOL) and EORTC QOL-C30 questionnaires **Time Frame:** 30 days post treatment **Description:** Number of participants having good outcome versus low outcomes. High score means worse health outcomes and low score means better health outcomes **Measure:** Participant outcomes using the Quality of Life (QOL) and EORTC QOL-C30 questionnaires **Time Frame:** 6 months post treatment **Description:** AEs will be evaluated using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5 **Measure:** Safety of the study treatment with be assessed by evaluating the number of participants experiencing Adverse Events (AEs) **Time Frame:** 30 days post treatment **Description:** Number of participants that have cycle treatment delays **Measure:** Treatment tolerability will be assessed **Time Frame:** 30 days post treatment **Description:** Number of participants that have cycle treatment cancelations **Measure:** Treatment tolerability will be assessed **Time Frame:** 30 days post treatment **Description:** Number of participants that have dose reductions **Measure:** Treatment tolerability will be assessed **Time Frame:** 30 days post treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥ 18 years of age at time of consent * ECOG performance status 0, 1, or 2 * Histologically confirmed invasive breast cancer documented by core needle or surgical biopsy with 90 days prior to study registration. * HER2-positive by IHC or FISH according to ASCO/CAP 2018 guidelines * HER2-enriched subtype on the MammaPrint/BluePrint gene expression profile within 90 days prior to study registration. * Curative resection of primary breast tumor(s) is planned; ipsilateral axillary nodes will be sampled by sentinel lymph node biopsy or axillary dissection * Treating Oncologist recommends neoadjuvant chemotherapy * No evidence of distant metastatic disease * AJCC clinical stage: cT1c-T3, cN0-N2 * Baseline left ventricular ejection fraction (LVEF) of at least 50% on Echo or MUGA scan within 90 days prior to registration. Adequate organ function as defined below: Leukocytes ≥2,000/mm3 Platelet count ≥ 75,000/mm3 Absolute Neutrophil Count (ANC) ≥ 1,000/mm3 Hemoglobin (Hgb) ≥ 9.0 g/dL Creatinine/Calculated Creatine clearance (CrCI) Cr \< 1.5 x upper limit of normal (ULN) or CrCl ≥ 50 mL/min using the Cockcroft-Gault formula Bilirubin ≤ 1.5 × ULN. Subjects with Gilbert's syndrome may have a bilirubin \> 1.5 × ULN, if no evidence of biliary obstruction exists Aspartate aminotransferase (AST) ≤ 2.5 × ULN Alanine aminotransferase (ALT) ≤ 2.5 × ULN * Patients with synchronous bilateral primary breast tumors or multiple ipsilateral primary breast tumors are eligible if the treating Oncologist determines that the assigned treatment regimen is appropriate therapy for all primary tumors requiring chemotherapy. * Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization. or the Legally Authorized Representative (LAR) is able to provide consent and HIPAA authorization. * Women of childbearing potential must agree to use a barrier form of contraception if they are sexually active with a male partner and cannot be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines. * As determined at the discretion of the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study. * Patients with history of HIV/AIDS (acquired immunodeficiency syndrome) are eligible for this study if they are receiving anti-retroviral therapy and it does not include any medications known to alter metabolism or tolerability of component drugs in the protocol treatment regimen and the following criteria is met: - Patients without a history of AIDS-defining opportunistic infections within the past 12 months. * Patients with Hepatitis B (HBV): chronic carriers of HBV infection (HBsAg-positive) or individuals who have serologic evidence of a resolved prior HBV infection (i.e., HBsAg-negative and anti-HBc-positive) are eligible if they are receiving appropriate suppressive antiviral therapy that does not include medications known to alter metabolism or tolerability of component drugs in the protocol treatment (see Appendix) prior to initiation of cancer therapy, and liver function tests meet study eligibility criteria. * Patients with Hepatitis C (HCV): patients with a history of HCV infection who have completed curative antiviral treatment are eligible if the HCV RNA viral load is below the limit of quantification within 90 days of study enrollment. Patients on concurrent HCV treatment must have HCV RNA viral load below the limit of quantification within 30 days of study enrollment. Patients must also meet liver function test eligibility requirements and antiviral therapy does not include medications known to alter metabolism or tolerability of component drugs in the protocol treatment Exclusion Criteria * Any prior therapy for this breast cancer * Active infection requiring systemic therapy at the time of study registration * Pregnant or nursing * Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist. * Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial. * Other major comorbidity (e.g., compromised liver function, major cardiovascular or cerebrovascular event within the past 6 months, uncontrolled diabetes mellitus or hypertension), as determined by treating physician. * Any contraindication for any chemotherapy drug used in the assigned regimen. * Baseline sensory neuropathy \> grade 1 * History of hypersensitivity to any of the drugs in the treatment regimen. Patients with history of hypersensitivity may be treated on this protocol with either nab-paclitaxel or docetaxel. * Prisoners **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** kent hoskins **Phone:** 3123550496 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Mercedes Carrasquillo, BS **Phone:** 3124131902 **Role:** CONTACT #### Locations **Location 1:** **City:** Chicago **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Kent Hoskins, MD - **Phone:** 312-355-0496 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Mercedes Carrasquillo, BS - **Phone:** 3124131902 - **Role:** CONTACT **Country:** United States **Facility:** University of Illinois **State:** Illinois **Status:** RECRUITING **Zip:** 60612 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms ### 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: D000074322 - Term: Antineoplastic Agents, Immunological ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M19537 - Name: Paclitaxel - Relevance: HIGH - As Found: Surgery - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: HIGH - As Found: Surgery - ID: M1668 - Name: Docetaxel - Relevance: HIGH - As Found: Physical - ID: M289243 - Name: Pertuzumab - Relevance: HIGH - As Found: Present - ID: M325 - Name: Trastuzumab - Relevance: HIGH - As Found: Quality - ID: M147959 - Name: Taxane - Relevance: LOW - As Found: Unknown - ID: M26197 - Name: Tubulin Modulators - Relevance: LOW - As Found: Unknown - ID: M26196 - Name: Antimitotic Agents - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000017239 - Term: Paclitaxel - ID: D000077143 - Term: Docetaxel - ID: D000068196 - Term: Albumin-Bound Paclitaxel - ID: D000068878 - Term: Trastuzumab - ID: C000485206 - Term: Pertuzumab ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441877 **Acronym:** 437_EsCom **Brief Title:** Community Spirit in Residence for the Elderly **Official Title:** The Elder at the Heart of His or Her Living Environment - Social Participation and Community Spirit in Residence for the Elderly #### Organization Study ID Info **ID:** 437_Esprit communauté #### Organization **Class:** OTHER **Full Name:** TOPMED ### Status Module #### Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-03 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-07 **Type:** ACTUAL **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-06-03 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** TOPMED #### 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 objective of our study is to observe and understand factors that emphasizes the creation of a community spirit. Specific objectives: 1. Explore and understand the facilitators and challenges of social participation in a residential context; 2. Explore and understand the facilitators and challenges of creating a sense of community in a residential setting. ### Conditions Module **Conditions:** - Sense of Community **Keywords:** - sense of community - social participation - sense of belonging - social cohesion ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Elderly residents who live in elderly home care service site 1 **Intervention Names:** - Other: No intervention **Label:** Residents site 1 #### Arm Group 2 **Description:** Elderly residents who live in elderly home care service site 2 **Intervention Names:** - Other: No intervention **Label:** Residents site 2 #### Arm Group 3 **Description:** Managers who work for the elderly home care service at site 1 **Intervention Names:** - Other: No intervention **Label:** Managers site 1 #### Arm Group 4 **Description:** Managers who work for the elderly home care service at site 2 **Intervention Names:** - Other: No intervention **Label:** Managers site 2 ### Interventions #### Intervention 1 **Arm Group Labels:** - Managers site 1 - Managers site 2 - Residents site 1 - Residents site 2 **Description:** There is no intervention, this is an observationnal study. **Name:** No intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** 13 items questionnaire with open questions in individual interview session format, factors are identified through qualitative analysis. **Measure:** Sense of community factors **Time Frame:** Up to 1 month after participants' recruitment **Description:** 10 items questionnaire used to measure the sense of community of the residents. Each item uses a 5 point scale (higher score means higher sense of community) **Measure:** Sense of community of the residents **Time Frame:** Up to two weeks prior to the interview session **Description:** 10 items questionnaire used to measure the managers' perception of the residents' sense of community. Each item uses a 5 point scale (higher score means perception of higher residents' sense of community) **Measure:** Managers' perception of the residents' sense of community **Time Frame:** Up to two weeks prior to the site residents' interview session #### Secondary Outcomes **Description:** 7 subitems asked in the questionnaire with open questions in individual interview session format, facilitators are identified through qualitative analysis. **Measure:** Sense of community facilitators **Time Frame:** Up to 1 month after participants' recruitment **Description:** 8 subitems asked in the questionnaire with open questions in individual interview session format, obstacles are identified through qualitative analysis. **Measure:** Sense of community obstacles **Time Frame:** Up to 1 month after participants' recruitment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: For site managers * Be a manager in the residences concerned * Be a department manager or * Hold a General Manager position or * Be a member of the partner's head office For residents * Residents of the autonomous wing of the targeted residences * Close caregiver of a resident of the residences included in the research project Exclusion Criteria: * Neurocognitive disorders * Significant language difficulties * Lack of verbal communication **Healthy Volunteers:** True **Minimum Age:** 40 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Elderly home care residents and the managers that work on site. The participants will be sampled from the selected community homes. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Edith Martin **Phone:** 4187801301 **Role:** CONTACT #### Locations **Location 1:** **City:** Québec **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Edith Martin, PhD - **Phone:** 4187801301 - **Role:** CONTACT **Country:** Canada **Facility:** TOPMED **State:** Quebec **Status:** RECRUITING **Zip:** G1S 1C1 ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441864 **Brief Title:** Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder **Official Title:** Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder #### Organization Study ID Info **ID:** STU00220863 #### Organization **Class:** OTHER **Full Name:** Northwestern University #### Secondary ID Infos **Domain:** Sleep Research Society Foundation **ID:** 09-SRG-23 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2025-03-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-03 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-03-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-28 **Study First Submit QC Date:** 2024-06-03 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Northwestern University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this clinical trial is learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD). People with RBD will be enrolled in the study along with their romantic partners. All participants will receive the treatment via videoconference and will complete 2 assessments. Participants with RBD will attend 7 sessions, and their partners will attend 2 of those sessions with them. ### Conditions Module **Conditions:** - Nightmare - Nightmare Disorder With Associated Other Sleep Disorder - REM Sleep Behavior Disorder **Keywords:** - Imagery Rehearsal Therapy - Cognitive Behavioral Therapy for Nightmares ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Multiple baseline single case experimental design ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive treatment after a 2-week baseline assessment period **Intervention Names:** - Behavioral: Cognitive Behavioral Therapy for Nightmares **Label:** 2-week baseline **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive treatment after a 4-week baseline assessment period **Intervention Names:** - Behavioral: Cognitive Behavioral Therapy for Nightmares **Label:** 4-week baseline **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 2-week baseline - 4-week baseline **Description:** The intervention will consist of 7 therapy sessions (once per week for 7 weeks) which will be delivered via videoconference. Partners will attend 2 of the 7 treatment sessions. During the sessions, participants will learn techniques for managing and changing nightmares. **Name:** Cognitive Behavioral Therapy for Nightmares **Other Names:** - Imagery Rehearsal Therapy **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The DDNSI is a questionnaire which measures the severity of nightmares. **Measure:** Disturbing Dream and Nightmare Severity Index (DDNSI) **Time Frame:** Through study completion (11-13 weeks) **Description:** The number of nightmares experienced each day will be collected on daily sleep diaries completed during each assessment period. **Measure:** Nightmare frequency (sleep diary) **Time Frame:** Through study completion (11-13 weeks) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosis of isolated RBD or RBD secondary to neurodegenerative disease * Age 18 or older * Speak, read, and write English * Live in the United States * Nightmare frequency ≥3 times per week * Disturbing Dream and Nightmare Severity Index score indicative of nightmare disorder * Sleep, neurological, and psychiatric medications stable for at least 1 month and willing to keep medications stable through the course of the study * Live with a romantic partner who is willing to participate in the study Exclusion Criteria: * Possible dementia * Narcolepsy * Posttraumatic stress disorder * Previous behavioral treatment for nightmares * Currently engaged in sleep- or trauma-focused psychotherapy * Taking a medication that could cause RBD, if the medication was started prior to onset of RBD symptoms Inclusion Criteria (Partners): * Live with a romantic partner who meets all of the above criteria * Age 18 or older * Speak, read, and write English * Live in the United States **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Chicago **Country:** United States **Facility:** Northwestern University **State:** Illinois **Zip:** 60611 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009422 - Term: Nervous System Diseases - ID: D000009461 - Term: Neurologic Manifestations - ID: D000020447 - Term: Parasomnias - ID: D000020923 - Term: REM Sleep Parasomnias ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - 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: M22015 - Name: REM Sleep Behavior Disorder - Relevance: HIGH - As Found: REM Sleep Behavior Disorder - ID: M22242 - Name: Parasomnias - Relevance: LOW - As Found: Unknown - ID: M15696 - Name: Sleep Wake Disorders - Relevance: HIGH - As Found: Sleep Disorders - ID: M4815 - Name: Mental Disorders - Relevance: HIGH - As Found: Behavior Disorder - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M22658 - Name: REM Sleep Parasomnias - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012893 - Term: Sleep Wake Disorders - ID: D000020187 - Term: REM Sleep Behavior Disorder - ID: D000001523 - Term: Mental Disorders ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441851 **Acronym:** VPN x RANP **Brief Title:** Study to Compare Two Partial Nephrectomy Techniques for Renal Tumors: Robot-assisted vs Videolaparoscopic **Official Title:** Randomized Clinical Trial to Compare Two Partial Nephrectomy Techniques for Renal Tumors: Robot-assisted vs Videolaparoscopic #### Organization Study ID Info **ID:** NP5030/2023 #### Organization **Class:** OTHER **Full Name:** Instituto do Cancer do Estado de São Paulo ### Status Module #### Completion Date **Date:** 2027-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-02 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-04-28 **Study First Submit QC Date:** 2024-06-02 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Instituto do Cancer do Estado de São Paulo #### Responsible Party **Investigator Affiliation:** Instituto do Cancer do Estado de São Paulo **Investigator Full Name:** MAURICIO DENER CORDEIRO **Investigator Title:** Principal Investigator, MD, PhD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Randomized, open-label clinical trial to compare renal volumetry pre and post operative in patients undergoing two types of partial nephrectomy techniques for renal tumors: robot-assisted vs videolaparoscopic. **Detailed Description:** Renal tumors are an important public health issue, representing approximately 4,2% of all newly diagnosed cancers around the world. Renal tumors are more prevalent in adults over 45 years old, and with higher frequency in men than women. Many risks factor have already been identified, including smoking (increase in twice the renal cancer risk), obesity, hypertension, and renal cancer familiar history. Surgery is one of the main treatment options for renal tumors and is considered the only curative treatment for localized ones. The most common surgeries used to treat it are Partial Nephrectomy (PN) and Radical Nephrectomy (RN). PN in indicated for smaller tumors (smaller than 4cm size) once it has already demonstrated renal function preservation and decrease chronic kidney disease (CDK) risk and cardiovascular events. Furthermore, RN is indicated for bigger tumors or for those who are centrally located in the middle of the kidney. In the last years, PN use have been increased and consequently, RN use has been decreased. According to a recent published study, PN use for T1a tumors increased from 20,2% in 2004, to 59,7% in 2015. Furthermore, 5-year cancer survival rates between patients undergone PN or RN was similar, with PN being more associated with lower general mortality rates. However, PN is technically more challenging and is associated with complications and local higher recurrence risks. Both are viable surgery options for renal tumors and the chosen technique of them should be considered according to surgeon expertise, patient's comorbidities, and tumor characteristics. There are some PN ways, including Open (OPN), Laparoscopic (LPN) and robot-assisted (RAPN), however the best technique is still unknown. Some studies have been comparing this three, and a recent 39-studies metanalysis evaluating 11.310 patients reported RAPN is which presented lower general complications, less warm ischemia period, and higher kidney function preservation rates in comparison with LPN or OPN. Other 29-studies metanalysis evaluating 5952 patients showed RAPN presented lower surgical and hospitalization periods compared to OPN and LPN. However, RANP is associated with higher costs and a longer learning curve than other NP techniques. Renal volumetry is an important measure for kidney function evaluation which aids on surgical approach choose for NP. In the present, there are some ways to evaluate pre and post operative kidney volumetry such as TC, RMN, and 3D ultrasonography (3DUS). A systematic review and metanalysis of 26 studies analyzed 1918 patients, and showed TC preoperative renal volumetry is the best way to predict postoperative kidney function and the need for a NP. Renal volumetry by TC and RMN postoperative also were considered good trustful measures to evaluate volumetry and remained kidney functions after PN. 3DUS appear to be a more economic and good measure to evaluate it with a good precision compared to what was found to TC and RMN. In general, pre and postoperative renal volumetry are an important measure to guide surgeons on the best surgery approach in PN, and right renal volumetry image evaluation should be considered according to costs available, patients characteristics and surgeon experience. Then, this study aims to compare NP techniques (VPN and RAPN) using renal volumetry pre and postoperative. ### Conditions Module **Conditions:** - Renal Cancer **Keywords:** - Renal cancer - Nephrectomy - Partial nephrectomy - Videolaparoscopic partial nephrectomy - Robot-assisted partial nephrectomy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients randomized to VPN group will be submitted to a videolaparoscopic partial nephrectomy in which lesion will be identified, renal artery will be selectively clamped and renal parenchyma will be section with scissors and cautery. Suture will be made in two planes with absorbable sutures. **Intervention Names:** - Procedure: Videolaparoscopic Partial Nephrectomy **Label:** Videolaparoscopic Partial Nephrectomy (VPN) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Patients randomized to RAN'P group will be submitted to a robot-assisted partial nephrectomy in which lesion will be identified, renal artery will be selectively clamped and renal parenchyma will be section with scissors and cautery. Suture will be made in two planes with absorbable sutures. **Intervention Names:** - Procedure: Robot-assisted Partial Nephrectomy **Label:** Robot-assisted Partial Nephrectomy (RANP) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Videolaparoscopic Partial Nephrectomy (VPN) **Description:** Videolaparoscopic partial nephrectomy **Name:** Videolaparoscopic Partial Nephrectomy **Other Names:** - VPN **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Robot-assisted Partial Nephrectomy (RANP) **Description:** Robot-assisted partial nephrectomy **Name:** Robot-assisted Partial Nephrectomy **Other Names:** - RAPN **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Renal volumetry measured by computadorized tomography **Measure:** Renal volumetry **Time Frame:** Up to 6 months after surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients between 18 and 99 years old; * Patients with non-metastatic renal cancer (confirmed by pre operatory TC); * Patients eligible for videolaparoscopic partial nephrectomy; * Patients who signed study informed consent form Exclusion Criteria: * Pregnant patients; * Patients with concomitant indications with nephrectomy; * Patients with a clinical condition that contraindicates nephrectomy; * Patients with a clinical condition that contraindicates robot-assisted surgeries (determined by urology team); * Patients with previous surgeries that contraindicates robot-assisted surgeries (determined by urology team); **Maximum Age:** 99 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Campbell S, Uzzo RG, Allaf ME, Bass EB, Cadeddu JA, Chang A, Clark PE, Davis BJ, Derweesh IH, Giambarresi L, Gervais DA, Hu SL, Lane BR, Leibovich BC, Pierorazio PM. Renal Mass and Localized Renal Cancer: AUA Guideline. J Urol. 2017 Sep;198(3):520-529. doi: 10.1016/j.juro.2017.04.100. Epub 2017 May 4. **PMID:** 28479239 **Citation:** Kutikov A, Uzzo RG. The R.E.N.A.L. nephrometry score: a comprehensive standardized system for quantitating renal tumor size, location and depth. J Urol. 2009 Sep;182(3):844-53. doi: 10.1016/j.juro.2009.05.035. Epub 2009 Jul 17. **PMID:** 19616235 **Citation:** Thompson RH, Lane BR, Lohse CM, Leibovich BC, Fergany A, Frank I, Gill IS, Blute ML, Campbell SC. Every minute counts when the renal hilum is clamped during partial nephrectomy. Eur Urol. 2010 Sep;58(3):340-5. doi: 10.1016/j.eururo.2010.05.047. Epub 2010 Jun 9. **PMID:** 20825756 **Citation:** Kim SP, Thompson RH, Boorjian SA, Weight CJ, Han LC, Murad MH, Shippee ND, Erwin PJ, Costello BA, Chow GK, Leibovich BC. Comparative effectiveness for survival and renal function of partial and radical nephrectomy for localized renal tumors: a systematic review and meta-analysis. J Urol. 2012 Jul;188(1):51-7. doi: 10.1016/j.juro.2012.03.006. Epub 2012 May 14. **PMID:** 22591957 **Citation:** Kutikov A, Egleston BL, Canter D, Smaldone MC, Wong YN, Uzzo RG. Competing risks of death in patients with localized renal cell carcinoma: a comorbidity based model. J Urol. 2012 Dec;188(6):2077-83. doi: 10.1016/j.juro.2012.07.100. Epub 2012 Oct 18. **PMID:** 23083850 **Citation:** Venkatesan AM, Kundu S, Sacks D, Wallace MJ, Wojak JC, Rose SC, Clark TW, d'Othee BJ, Itkin M, Jones RS, Miller DL, Owens CA, Rajan DK, Stokes LS, Swan TL, Towbin RB, Cardella JF; Society of Interventional Radiology Standards of Practice Committee. Practice guidelines for adult antibiotic prophylaxis during vascular and interventional radiology procedures. Written by the Standards of Practice Committee for the Society of Interventional Radiology and Endorsed by the Cardiovascular Interventional Radiological Society of Europe and Canadian Interventional Radiology Association [corrected]. J Vasc Interv Radiol. 2010 Nov;21(11):1611-30; quiz 1631. doi: 10.1016/j.jvir.2010.07.018. No abstract available. Erratum In: J Vasc Interv Radiol. 2011 Feb;22(2):263. **PMID:** 21029949 **Citation:** Lane BR, Abouassaly R, Gao T, Weight CJ, Hernandez AV, Larson BT, Kaouk JH, Gill IS, Campbell SC. Active treatment of localized renal tumors may not impact overall survival in patients aged 75 years or older. Cancer. 2010 Jul 1;116(13):3119-26. doi: 10.1002/cncr.25184. **PMID:** 20564627 **Citation:** Zini L, Perrotte P, Capitanio U, Jeldres C, Shariat SF, Antebi E, Saad F, Patard JJ, Montorsi F, Karakiewicz PI. Radical versus partial nephrectomy: effect on overall and noncancer mortality. Cancer. 2009 Apr 1;115(7):1465-71. doi: 10.1002/cncr.24035. **PMID:** 19195042 **Citation:** Ficarra V, Novara G, Secco S, Macchi V, Porzionato A, De Caro R, Artibani W. Preoperative aspects and dimensions used for an anatomical (PADUA) classification of renal tumours in patients who are candidates for nephron-sparing surgery. Eur Urol. 2009 Nov;56(5):786-93. doi: 10.1016/j.eururo.2009.07.040. Epub 2009 Aug 4. **PMID:** 19665284 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014571 - Term: Urologic Neoplasms - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000007674 - Term: Kidney Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000000230 - Term: Adenocarcinoma - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5548 - Name: Carcinoma, Renal Cell - Relevance: HIGH - As Found: Renal Cancer - ID: M10703 - Name: Kidney Neoplasms - Relevance: HIGH - As Found: Renal Cancer - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M17320 - Name: Urologic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M3585 - Name: Adenocarcinoma - 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: T4906 - Name: Renal Cell Carcinoma - Relevance: HIGH - As Found: Renal Cancer ### Condition Browse Module - Meshes - ID: D000007680 - Term: Kidney Neoplasms - ID: D000002292 - Term: Carcinoma, Renal Cell ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441838 **Brief Title:** The Effect of Listening to Surah Inshirah on Mental Health in Hemodialysis Patients. **Official Title:** The Effect of Listening to the Inshirah Surah on Depression, Anxiety, Stress and Mental Well-Being in Hemodialysis Patients. #### Organization Study ID Info **ID:** Mardin Artuklu Üniversitesi #### Organization **Class:** OTHER **Full Name:** Hasan Kalyoncu University ### Status Module #### Completion Date **Date:** 2024-03-23 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-03 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-03-23 **Type:** ACTUAL #### Start Date **Date:** 2024-02-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-04-20 **Study First Submit QC Date:** 2024-06-03 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hasan Kalyoncu University #### Responsible Party **Investigator Affiliation:** Mardin Artuklu University **Investigator Full Name:** Omer Tanriverdi **Investigator Title:** Asistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** In addition to physical symptoms, mental, social and economic problems may also occur in patients receiving hemodialysis treatment. The most prominent among these problems are psychological problems. It is known that depression and anxiety levels are high in hemodialysis patients.Non-pharmacological methods reduce the patient's pain and anxiety by creating a feeling of comfort and control in the patient. Relaxation techniques such as hypnosis, yoga and music are among these. The main purpose of these methods is to draw the attention of the individual in another direction. Praying is also one of the non-drug methods, and the number of studies on this subject is very limited, and there are studies where it has been determined that praying and praying reduces the anxiety levels of patients.Purpose: To examine the effect of listening to Surah Inshirah on depression, anxiety, stress and mental well-being of hemodialysis patients during treatment. Method: The population of the research will consist of hemodialysis patients who are treated at Mardin Training and Research Hospital, meet the inclusion criteria and volunteer to participate in the research. The study group of 60 people who will participate in the research will be divided into two equal groups according to the table of random numbers obtained from the computer-based Research Randomizer program. Experimental group patients; A patient descriptive characteristics form will be applied, and the pre-test depression, anxiety, stress and mental well-being scale will be applied. Then, Surah Inshirah will be listened to and the final test, the depression, anxiety, stress and mental well-being scale, will be applied. Control group patients; A patient descriptive characteristics form will be applied, and the depression, anxiety, stress and mental well-being scale will be applied. The final test will be applied to the depression, anxiety, stress and mental well-being scale without any intervention. ### Conditions Module **Conditions:** - Hemodialysis Patients ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 60 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Experimental group patients; A patient descriptive characteristics form will be administered, and the pre-test Depression, Stress, Anxiety Scale and Warwick-Edinburgh Mental Well-Being Scale will be administered. Then, Surah Inshirah will be listened to and the final test, Depression, Stress, Anxiety Scale and Warwick-Edinburgh Mental Well-Being Scale will be administered. **Intervention Names:** - Behavioral: Surah Inshirah **Label:** Listening to Surah Inshirah **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** intervention group patients; Patient descriptive characteristics form, Depression, Stress, Anxiety Scale and Warwick-Edinburgh Mental Well-Being Scale will be administered. Then, the Depression, Stress, Anxiety Scale and Warwick-Edinburgh Mental Well-Being Scale will be administered 1 month later without any intervention. **Label:** control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Listening to Surah Inshirah **Description:** The effects of Surah Al-Inshirah on patients' depression, anxiety, stress and mental well-being will be evaluated during hemodialysis in the experimental group. **Name:** Surah Inshirah **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** It consists of 14 questions **Measure:** mental well-being scale **Time Frame:** Baseline (It will be applied to patients before hemodialysis) #### Primary Outcomes **Description:** This form, created by the researcher with the support of the relevant literature, consists of 8 questions that question the patients' education level, age, gender, profession, marital status, income level, with whom they live, and duration of illness. **Measure:** patient information form **Time Frame:** Baseline (It will be applied to patients before hemodialysis) #### Secondary Outcomes **Description:** It consists of 7 depression, 7 anxiety and 7 stress questions. **Measure:** depression anxiety stress scale **Time Frame:** Baseline (It will be applied to patients before hemodialysis) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients who can be contacted,Patients aged 18 and over were included in the study. Exclusion Criteria: * Patients aged 18 and over were included in the study. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Mardin **Country:** Turkey **Facility:** Ömer TANRIVERDİ ## Derived Section ### 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: LOW - As Found: Unknown - ID: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441825 **Acronym:** POWER-MG **Brief Title:** Patient Observation With Environmental and Wearable Sensors in Myasthenia Gravis **Official Title:** Patient Observation With Environmental and Wearable Sensors in Myasthenia Gravis #### Organization Study ID Info **ID:** MPGv1.0 #### Organization **Class:** OTHER **Full Name:** Heinrich-Heine University, Duesseldorf ### Status Module #### Completion Date **Date:** 2025-10-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-10-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-02 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Heinrich-Heine University, Duesseldorf #### Responsible Party **Investigator Affiliation:** Heinrich-Heine University, Duesseldorf **Investigator Full Name:** Dr. med. Marc Günter Pawlitzki **Investigator Title:** Senior 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 observational study seeks to investigate the underlying processes of myasthenia gravis by employing multimodal monitoring techniques. By integrating digital biomarkers alongside clinical monitoring, we aim to enhance the detection of disease activity and establish correlations between digital measures, clinical scores and various questionnaires including sores on quality of life, sleep quality or activities of daily living. Primarily including patients treated with newly approved drugs, it aims at improving and monitoring the efficacy and safety of treatment and allowing a more individualized treatment. **Detailed Description:** Myasthenia Gravis (MG) is a chronic autoimmune disease characterized by muscle weakness and fatigue due to defective transmission at the neuromuscular junction. Typically, symptomatic assessments occur during clinical encounters, either as part of routine treatment assessments or in acute situations such as myasthenic crises. However, for a comprehensive understanding of mechanisms in MG and disease activity, continuous monitoring is essential. Utilization of digital biomarkers derived from wearable devices offers unprecedented insights into diseases like MG and allows us to establish correlations between digital measures, clinical scores such as the QMG scale and MGC, as well as various questionnaires addressing sleep quality, quality of life or activities of daily living. Data recorded by the used wearables (Withings Scanwatch 2) cover various parameters including activity-related data (step count, minutes in certain intensity levels), basic cardiovascular measurements such as heart rate, and sleep-related data (total time asleep, sleep quality, etc.). Prospectively, this study aims at improving patient care by gaining a deeper insight into Myasthenia Gravis and its dynamic disease activity while concurrently monitoring the efficacy and safety of treatments, particularly of the newly approved drugs for MG. In the future, wearables might hold the potential to improve treatment processes and optimize therapeutic approaches. For instance, digital biomarkers could serve as early warning signs for phenomena like heightened disease activity or end-of-dose phenomena, paving the way for personalized treatment strategies tailored to individual patient needs. ### Conditions Module **Conditions:** - Myasthenia Gravis - Myasthenic Syndrome - Lambert-Eaton Myasthenic Syndrome ### Design Module #### Bio Spec **Description:** - Blood serum **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Cohort to be characterized via clinical, serological and digital observations **Intervention Names:** - Other: Increased multimodal observation including digital monitoring **Label:** Myasthenic Syndromes Observational Cohort ### Interventions #### Intervention 1 **Arm Group Labels:** - Myasthenic Syndromes Observational Cohort **Description:** Digital monitoring combined with repeated clinical assessments and retrospective analysis of serological markers **Name:** Increased multimodal observation including digital monitoring **Other Names:** - Withings Scanwatch 2 **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The QMG-Score is a clinical tool to assess the severity of symptoms in MG. It evaluates muscle strength and function in specific muscle groups (ocular, oral, facial, neck and limb muscles), grip strength and vital capacity. It ranges from 0 to 39, with higher scores indicating an increased symptom load. **Measure:** QMG: Quantitative Myasthenia Gravis Scale **Time Frame:** 6 months, monthly **Description:** The MGC is a clinical tool to evaluate the severity and progression of MG. It ranges from 0 to 50, with higher scores indicating a higher severity of MG. **Measure:** MGC: Myasthenia Gravis Composite **Time Frame:** Baseline, after 3 and 6 months **Description:** The MGFA-PIS is a scoring system used to assess the status of patients with MG. It divides MG presentations into different classes, classifying outcome measures and treatment effectiveness. It has 8 classes; Minimal Manifestation can be further described within four dimensions. **Measure:** MGFA-PIS: Myasthenia Gravis Post intervention status **Time Frame:** Baseline, after 3 and 6 months **Description:** The MG-ADL is a tool used to assess the functional status of patients with MG in their daily activities. It consists of questions related to various activities of daily living such as speaking, chewing, swallowing, walking etc. It ranges from 0 to 24, with higher scores indicating a greater impairment in daily life. **Measure:** MG-ADL: Myasthenia Gravis Activities of Daily Living **Time Frame:** Baseline, after 3 and 6 months **Description:** The MG-QoL assesses the quality of life in patients with MG, covering various aspects of daily life such as physical functioning, social interactions, emotional well-being and overall satisfaction with life. It ranges from 0 to 60, with higher scores indicating a greater impact of MG on life quality. **Measure:** MG-QoL15: Myasthenia Gravis Quality of Life-15 **Time Frame:** Baseline, after 3 and 6 months #### Secondary Outcomes **Description:** The WHOQOL-BREF questionnaire measures quality of life across 4 domains: Physical health, psychological health, social relationships and environment. It also includes one question on overall QOL and one on general health. The WHOQOL-BREF scores correlate highly (.89 or above) with WHOQOL-100 scores, and demonstrate good discriminant validity, content validity, internal consistency and test-retest reliability. The four WHOQOL-BREF domain scores will be used as main outcome measure. The measure is calculated by summing the point values for the questions corresponding to each domain and then transforming the scores to a 0-100 point interval, with higher scores corresponding to greater QOL. **Measure:** WHOQoL-BREF: World Health Organization Quality of Life Questionnaire Brief Version **Time Frame:** Baseline, after 3 and 6 months **Description:** The HADSD is a self-assessment questionnaire measuring levels of anxiety and depression in patients. It contains two subscales: one for anxiety and one for depression. Total scores range from 0 to 42, with higher scores indicatiBAng higher levels of anxiety or depression. **Measure:** HADSD: Hospital Anxiety and Depression Scale **Time Frame:** Baseline, after 3 and 6 months **Description:** The EoD-Questionnaire assesses the effectiveness of a treatment at the end of its dosing interval and asks about an increase in symptoms. **Measure:** EoD-Questionnaire: End of Dose-Questionnaire **Time Frame:** Baseline, after 3 and 6 months **Description:** The Sleep-Questionnaire contain the Pittsburgh Sleep Quality Index (PSQI) as well as two Items on the perceived impact of the smartwatch on the patient´s sleep. The PSQI assesses the quality of sleep over a one-month interval and measures seven component scores: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Total score ranges from 0 to 21, with higher scores indicating a poorer sleep quality. **Measure:** Sleep-Questionnaire: **Time Frame:** Baseline, after 3 and 6 months **Measure:** 10. Questionnaire on Smartwatch Usage (after 6 Months) containing the System Usability Scale **Time Frame:** After 6 months **Measure:** Digital Measurements: Activity parameters - Longitudinal development of step count **Time Frame:** 6 months, continuously **Measure:** Digital Measurements: Activity parameters - longitudinal development of approximate distance travelled (meter) **Time Frame:** 6 months, continuously **Measure:** Digital Measurements: Activity parameters - longitudinal development of duration of soft activity (seconds) as defined by Withings **Time Frame:** 6 months, continuously **Measure:** Digital Measurements: Activity parameters - longitudinal development of duration of moderate activity (seconds) as defined by Withings **Time Frame:** 6 months, continuously **Measure:** Digital Measurements: Activity parameters - longitudinal development of duration of itnense activity (seconds) as defined by Withings **Time Frame:** 6 months, continuously **Measure:** Digital Measurements: Activity parameters - longitudinal development of active time (seconds) as defined by Withings **Time Frame:** 6 months, continuously **Measure:** Digital Measurements: Activity parameters - longitudinal development of approximate calories burned as defined by Withings **Time Frame:** 6 months, continuously **Measure:** Digital Measurements: Sleep parameters - longitudinal development of time awake (seconds) **Time Frame:** 6 months, continuously **Measure:** Digital Measurements: Sleep parameters - longitudinal development of number of times user woke up **Time Frame:** 6 months, continuously **Measure:** Digital Measurements: Sleep parameters - longitudinal development of time to sleep (seconds) **Time Frame:** 6 months, continuously **Measure:** Digital Measurements: Sleep parameters - longitudinal development of total time asleep (seconds) **Time Frame:** 6 months, continuously **Measure:** Digital Measurements: Sleep parameters - longitudinal development of total time in bed (seconds) **Time Frame:** 6 months, continuously **Measure:** Digital Measurements: Sleep parameters - longitudinal development of ratio of sleep/time in bed **Time Frame:** 6 months, continuously **Measure:** Digital Measurements: Sleep parameters - longitudinal development of time spent in bed before falling asleep (seconds) **Time Frame:** 6 months, continuously **Measure:** Digital Measurements: Sleep parameters - longitudinal development of time awake after first falling asleep (seconds) **Time Frame:** 6 months, continuously **Measure:** Digital Measurements: Sleep parameters - longitudinal development of Withings sleep Score as defined by Withings **Time Frame:** 6 months, continuously **Measure:** Digital Measurements: Cardiovascular parameters - longitudinal development of average heartrate (beats/min) **Time Frame:** 6 months, continuously **Measure:** Digital Measurements: Cardiovascular parameters - longitudinal development of maximal heartrate (beats/min) **Time Frame:** 6 months, continuously **Measure:** Digital Measurements: Cardiovascular parameters - longitudinal development of minimum heartrate (beats/min) **Time Frame:** 6 months, continuously **Measure:** Digital Measurements: Cardiovascular parameters - longitudinal development of time in light heartrate zone (seconds) **Time Frame:** 6 months, continuously **Measure:** Digital Measurements: Cardiovascular parameters - longitudinal development of time in moderate heartrate zone (seconds) **Time Frame:** 6 months, continuously **Measure:** Digital Measurements: Cardiovascular parameters - longitudinal development of time in intense heartrate zone (seconds) **Time Frame:** 6 months, continuously **Measure:** Digital Measurements: Cardiovascular parameters - longitudinal development of time in maximal heartrate zone (seconds) **Time Frame:** 6 months, continuously **Measure:** Digital Measurements: Cardiovascular parameters - longitudinal development of heart rate variability (milliseconds) **Time Frame:** 6 months, continuously **Description:** Wearing time of smartwatch (daily) **Measure:** Smartwatch adherence **Time Frame:** Continously 6 motnhs ### Eligibility Module **Eligibility Criteria:** * Formal diagnosis of generalized Myasthenia Gravis, with at least one of the following criteria: * Response to oral or intravenous administration of an acetylcholinesterase inhibitor * Evidence of pathological decrement/ elevated jitter * Evidence of Myasthenia Gravis-typical antibody (AChR, LRP4, MuSK, Titin) OR other diagnosed Myasthenic Syndrome * Age ≥ 18 * Usage of Smartphone with Android 8.1 (or higher) or IOS12.3 (or higher) * Able to provide informed consent, based on investigator´s judgment Exclusion Criteria: Patients who meet any of the following criteria will be excluded from participation: * Unable or unwilling to give informed consent * Unable or unwilling to use the smartphone app * Any significant comorbidity that might potentially interfere with the ability to successfully participate in the study, based on investigator´s judgment * Patient with exclusively ocular symptoms (ocular myasthenia gravis) **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with myasthenic syndromes treated at the University Clinic Duesseldorf. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Marc Pawlitzki, PD Dr. med. **Phone:** +49211 8117887 **Role:** CONTACT #### Locations **Location 1:** **City:** Duesseldorf **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Marc Günter Pawlitzki, PD Dr. med. - **Phone:** +49211 8117887 - **Role:** CONTACT ***Contact 2:*** - **Name:** Lars Masanneck, Dr. med. - **Role:** CONTACT **Country:** Germany **Facility:** Heinrich-Heine University, Duesseldorf **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - 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: D000020361 - Term: Paraneoplastic Syndromes, Nervous System - ID: D000009423 - Term: Nervous System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000010257 - Term: Paraneoplastic Syndromes - ID: D000020274 - Term: Autoimmune Diseases of the Nervous System - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000020511 - Term: Neuromuscular Junction Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M12112 - Name: Myasthenia Gravis - Relevance: HIGH - As Found: Myasthenia Gravis - ID: M18224 - Name: Lambert-Eaton Myasthenic Syndrome - Relevance: HIGH - As Found: Myasthenic Syndrome - ID: M20944 - Name: Muscle Weakness - Relevance: HIGH - As Found: Myasthenia - 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 - ID: M13170 - Name: Paraneoplastic Syndromes - Relevance: LOW - As Found: Unknown - ID: M22160 - Name: Paraneoplastic Syndromes, Nervous System - Relevance: LOW - As Found: Unknown - ID: M12367 - Name: Nervous System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M22094 - Name: Autoimmune Diseases of the Nervous System - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M22297 - Name: Neuromuscular Junction Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T3973 - Name: Myasthenia Gravis - Relevance: HIGH - As Found: Myasthenia Gravis - ID: T3299 - Name: Lambert Eaton Myasthenic Syndrome - Relevance: HIGH - As Found: Myasthenic Syndrome ### Condition Browse Module - Meshes - ID: D000009157 - Term: Myasthenia Gravis - ID: D000015624 - Term: Lambert-Eaton Myasthenic Syndrome - ID: D000018908 - Term: Muscle Weakness - ID: D000013577 - Term: Syndrome ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441812 **Brief Title:** A Study to Evaluate the Long-term Safety, Pharmacodynamics and Efficacy of SHR-1703 in Eosinophilic Asthma Patients **Official Title:** A Multicenter, Single-group Phase II Clinical Study to Evaluate the Long-term Safety, Pharmacodynamics and Efficacy of Multiple Subcutaneous Injections of SHR-1703 in Eosinophilic Asthma Patients #### Organization Study ID Info **ID:** SHR-1703-202 #### Organization **Class:** INDUSTRY **Full Name:** Guangdong Hengrui Pharmaceutical Co., Ltd ### Status Module #### Completion Date **Date:** 2027-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Guangdong Hengrui Pharmaceutical Co., Ltd #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The purpose of this study is to evaluation the long-term Safety, Pharmacodynamics and Efficacy of SHR-1703 in Eosinophilic Asthma Patients ### Conditions Module **Conditions:** - Eosinophilic Asthma Patients ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: SHR-1703 Injection **Label:** SHR-1703 Injection **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - SHR-1703 Injection **Description:** SHR-1703 Injection **Name:** SHR-1703 Injection **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Adverse Events in main peroid，about 1 year **Time Frame:** about 1 year #### Secondary Outcomes **Measure:** Absolute count of eosinophils , about 1 year **Time Frame:** about 1 year **Measure:** Change of FEV1 、FEV1%pred、FVC、PEF，about 1 year. **Time Frame:** about 1 year. **Measure:** Change of Fractional Exhaled Nitric Oxide (FeNO) ，about 1 year. **Time Frame:** about 1 year. **Measure:** Questionnaire about asthma，about 1 year . **Time Frame:** about 1 year . **Measure:** Frequency and time of asthma exacerbation , about 2 years **Time Frame:** about 2 years **Measure:** Reduction in asthma controller , about 1 year **Time Frame:** about 1 year **Measure:** Asthma remission, about 2 years **Time Frame:** about 2 years **Measure:** Daily OCS use and reduction, about 1 year. **Time Frame:** about 1 year. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. At least 18 years of age, Male or Femal. 2. A minimum weight of 40kg. 3. Subjects with the clinical features of asthma that meets the diagnostic criteria of the "Guidelines for the Prevention and Treatment of Bronchial Asthma (2020 Edition)" and has a medical history of at least 1 year. 4. Documentation of current asthma controller medication \[medium or high dose ICS and at least one of additional controller such as long-acting muscarinic antagonist (LAMA), long-acting beta2-agonist (LABA) and leukotriene receptor antagonist (LTRA)\] for at least 1 stable month before first administration of SHR-1703. 5. At least one confirmed history of exacerbation within one year of initial administration of SHR-1703, occurring during the use of medium and high daily dose ICS. 6. Absolute count of eosinophils must be ≥0.15×109/L at visit 0 and visit 1. 7. A pre-bronchodilator FEV1 \<80% and ≥30% predicted at visit 0 and visit 1. 8. Female subjects with fertility agree to have no plan pregnancy and voluntarily adopt high-efficiency contraception measures from signing the informed consent form to 15 months after the last dose of SHR-1703, and male subjects with fertility as partners agree to have no plan pregnancy and voluntarily adopt high-efficiency contraception measures between the first dose of SHR-1703 and the last visit in the study. 9. Subjects must be able to give written informed consent prior to participation in the study. Exclusion Criteria: 1. Presence of a clinically important lung condition. This includes but is not limited to current infection, bronchiectasis, pulmonary fibrosis, (chronic obstructive pulmonary disease other than asthma) or a history of lung cancer. 2. A known immunodeficiency. 3. Presence of a clinically significant and uncontrolled serious cardiovascular and cerebrovascular disease, including but not limited to myocardial infarction, unstable angina, heart failure, stroke, and subarachnoid haemorrhage. 4. Within the first 4 weeks before visit 0, presence of exacerbation of allergic rhinitis or sinusitis, or a history of infections with clinical significance and/or requiring clinical intervention, including but not limited to respiratory infections. 5. A known parasitic infection within the first 6 months before visit 0. 6. A malignancy history within the first 5 years before visit 0 (Subjects that had localized basal carcinoma of the skin or cervical carcinoma in situ which was resected for cure will not be excluded). 7. Blood donation or significant blood loss (≥ 400ml) within the first 4 weeks before visit 0, or infusion of blood products or immunoglobulins. 8. Use systemic immunosuppressants (excluding systemic glucocorticoids used for asthma treatment and for non asthma treatment for less than 3 days) or immunomodulators, or biologics or Th2 cytokine inhibitors, including but not limited to methotrexate, cyclosporine, interferon-α, anti IL-5 monoclonal antibodies (including SHR-1703), anti IL-4R monoclonal antibodies, anti TSLP monoclonal antibodies, anti IgE monoclonal antibodies, metformin, etc., and within 5 half-lives of the drug before the first administration (refer to the longer drug instructions; for those with unknown half-lives, 12 weeks before the first administration shall prevail); 9. Subjects who have previously participated in any study and received Investigational Product within the first 30 days before visit 0. 10. There was a surgical plan or other treatment measures that the researcher believed may affect the subject's evaluation during the study period. 11. Laboratory examination shows obvious abnormalities at visit 0 and visit 1: 1. White blood cell count (WBC) \<3.0×109/L; 2. Hemoglobin≤90g/L； 3. Platelet\<100×109/L； 4. Alanine aminotransferase (ALT)\>2×ULN (upper limit of normal); 5. Aspartate aminotransferase (AST) \>2×ULN； 6. Total bilirubin (TBIL)\>1.5×ULN; 7. Prothrombin time (PT) \>ULN+3s； 8. Creatinin\>1.5×ULN; 9. Active hepatitis B (positive for hepatitis B virus deoxyribonucleic acid (HBV DNA) in peripheral blood), or positive for hepatitis C virus antibody, or positive for human immunodeficiency virus (HIV) antibody, or positive for treponema pallidum antibody； 12. ECG QTc\>450ms or other clinically significant abnormal results that may pose significant safety risks to the subjects at visit 0 or visit 1； 13. A history of drug addicts or substance abuse within 1 years prior to Visit 0； 14. Subjects who are pregnant (positive HCG test at visit 0 or visit 1) or breastfeeding should not be enrolled if they plan to become pregnant during the time of study participation； 15. Subjects with a known allergy or intolerance to anti IL-5 monoclonal antibody or other biologic； 16. Other reasons determined by the researcher as unsuitable for participation 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:** Tianqi Zheng **Phone:** +0518-81220121 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001982 - Term: Bronchial Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000008171 - Term: Lung Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases - ID: D000017681 - Term: Hypereosinophilic Syndrome - ID: D000004802 - Term: Eosinophilia - ID: D000007960 - Term: Leukocyte Disorders - ID: D000006402 - Term: Hematologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4556 - Name: Asthma - Relevance: HIGH - As Found: Asthma - ID: M14511 - Name: Pulmonary Eosinophilia - Relevance: HIGH - As Found: Eosinophilic Asthma - ID: M7961 - Name: Eosinophilia - Relevance: LOW - As Found: Unknown - ID: M5258 - Name: Bronchial Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M19901 - Name: Hypereosinophilic Syndrome - Relevance: LOW - As Found: Unknown - ID: M10963 - Name: Leukocyte Disorders - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: T2886 - Name: Hypereosinophilic Syndrome - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001249 - Term: Asthma - ID: D000011657 - Term: Pulmonary Eosinophilia ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441799 **Acronym:** YM-1 **Brief Title:** Study on the Safety, Efficacy of Home RF Cosmetic Instrument in the Treatment of Facial or Periorbital Wrinkles **Official Title:** A Prospective, Randomized, Rate-blind, Multicenter, Optimity-designed Clinical Trial Evaluating the Safety and Efficacy of RFskin Therapy Devices for the Reduction of Skin Wrinkles #### Organization Study ID Info **ID:** YM-1 #### Organization **Class:** INDUSTRY **Full Name:** Glomed(HN)Co.Ltd ### Status Module #### Completion Date **Date:** 2023-08-29 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-08-29 **Type:** ACTUAL #### Start Date **Date:** 2023-04-17 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Glomed(HN)Co.Ltd #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a multicenter trial with randomized control and evaluator blind method, which meets the screening criteria total of 224 subjects were enrolled and randomly divided into control group and experiment according to 1:1 ratio Group), the subjects in the control group used medical ultrasonic coupler, and the subjects in the test group used test instruments Combined with medical ultrasonic coupler, use 5 days per week according to the prescribed use method (duration:Use the whole face for 10 minutes, use twice a day, a total of 20 minutes), continuous use 12Week. The changes of relevant clinical indicators and laboratory instrument measurements were evaluated. Objective : To evaluate the efficacy of radiofRF in reducing skin wrinkles and treating loose skin after 12 weeks of use of the test product Effectiveness and safety of relaxation and firming of skin tissue. The subjects were adults aged 18 years and above, regardless of gender, and had obvious wrinkles on the skin around the face and eyes (according to the selection Standard confirmation). **Detailed Description:** The purpose of the clinical trial was to see if home radiofrequency beauty devices were effective in treating adults for reducing skin wrinkles. It will also learn about the safety of home RF beauty devices. The main questions it aims to answer are: 1. Reduction of facial or periocular wrinkles based on Fitzpatrick score (12 weeks); 2. Possible adverse reactions and satisfaction survey during the use of subjects; The researchers will compare the radiofrequency beauty device group with the control group (only medical ultrasonic coupling) to verify whether the home radiofrequency beauty device is effective in reducing skin wrinkles. Participants will: Receive home treatment according to the experimental group and continue to use it for 12 weeks. At the 6th and 12th week, they will visit the medical institution for questionnaire survey and skin test. Keep a diary of their symptoms and the number of times they use radiofrequency beauty device or medical ultrasonic coupling. ### Conditions Module **Conditions:** - Skin Wrinkles **Keywords:** - Rf beauty device for home use - Treatment of facial or periorbital wrinkles ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The method of randomized control and evaluator blindness is suitable for screening A total of 224 subjects were enrolled and randomly divided into control group and experiment according to 1:1 ratio Group) ##### Masking Info **Masking:** SINGLE **Masking Description:** Three doctors set up a blind evaluation group to evaluate the photos of the subjects before and after receiving the device treatment **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 224 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Radiofrequency skin therapy instrument with medical ultrasound coupler is used for 20 minutes a day, 5 days a week **Intervention Names:** - Device: Home radiofrequency skin treatment instrument **Label:** Home radiofrequency skin treatment instrument **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Medical ultrasound coupler is applied to the face for 20 minutes a day, 5 days a week **Intervention Names:** - Other: Ultrasonic coupler for medical purposes **Label:** Medical ultrasound coupler **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Home radiofrequency skin treatment instrument **Description:** Subjects in the experimental group were treated with the test instrument combined with medical ultrasonic coupler for 5 days a week according to the prescribed use method (duration of use: 10 minutes for the whole face, continuous use twice a day, a total of 20 minutes) for 12 weeks. To evaluate the reduction of wrinkles before and after treatment and the changes of laboratory instruments. **Name:** Home radiofrequency skin treatment instrument **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Medical ultrasound coupler **Description:** In control group, medical ultrasonic coupler was evenly applied on face and orbit for 5 days a week (duration: 20 minutes) for 12 consecutive days Week. To evaluate the reduction of wrinkles and the change of laboratory instruments before and after use. **Name:** Ultrasonic coupler for medical purposes **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** After 12 weeks of treatment, wrinkles were more severe on a 0-9 scale (Fitzpatrick scale) Percentage of subjects with at least one grade (1 point) reduction at baseline. **Measure:** Wrinkle reduction efficiency based on Fitzpatrick score **Time Frame:** 12th week #### Secondary Outcomes **Description:** After 6 weeks of treatment, wrinkles were more severe on a 0-9 scale (Fitzpatrick scale) Percentage of subjects with at least one grade (1 point) reduction at baseline. **Measure:** Wrinkle reduction efficiency based on Fitzpatrick score **Time Frame:** 6th week **Description:** The R2 and F4 values of the two groups were compared after 6 weeks /12 weeks after using the RF instrument. **Measure:** R2 and F4 values measured by the Cutometer dual MPA580 **Time Frame:** 6th week\12th week **Description:** PRIMOS-CR measured crow's feet and under-eye lines and compared the number of wrinkles between the two groups Quantity, length **Measure:** PRIMOS-CR measures the length and number of skin wrinkles **Time Frame:** 6th week\12th week **Description:** According to the researchers' Skin Aging Atlas (R.Busin, F.folament), skin aging Tu (Volume 2 Asian Edition). Translated by Qiu Huixia et al. \[M\]. Paris: MED 'com, 2010.) " To assess the severity of the subject's lower bilateral sagging. According to the researchers' Skin Aging Atlas (R.Busin, F.folament), skin aging Tu (Volume 2 Asian Edition). Translated by Qiu Huixia et al. \[M\]. Paris: MED 'com, 2010.) " To assess the severity of the subject's lower bilateral sagging. According to the researchers' Skin Aging Atlas (R.Busin, F.folament), skin aging Tu (Volume 2 Asian Edition). Translated by Qiu Huixia et al. \[M\]. Paris: MED 'com, 2010.) " To assess the severity of the subject's lower bilateral sagging **Measure:** Lower face sag evaluation **Time Frame:** 6th week\12th week **Description:** The participants received a questionnaire at the last visit, which mainly included the skin improvement effect of the product And the satisfaction degree of ease of operation **Measure:** Subject satisfaction evaluation **Time Frame:** 6th week\12th week ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * (1) Adults aged 18 and above, male or female; * (2) Fitzpatrick's wrinkles and elasticity scores around the face and eyes were 2-7 points (on-site assessment); * (3) To avoid sun exposure during the test; * (4) Be able to read Chinese and accurately understand, and sign the informed consent of the test; * (5) can cooperate with and participate in the test return visit time, and timely reflect their own health status or any changes in drugs, adverse reaction symptoms; * (6) Urine pregnancy reaction is negative (women of childbearing age). Exclusion Criteria: * (1) Abnormal vital signs (blood pressure, pulse, body temperature), except for minor abnormalities that are not clinically significant as determined by the doctor; * (2) There is a pacemaker or internal defibrillator in the body, or any other active electrical implant anywhere in the body; * (3) The treatment area has permanent implants, such as metal plates and screws (e.g. dentures, metal teeth), silicone implants or injected chemicals; * (4) There is or has been a history of skin cancer, or any other type of cancer, or malignant pre-nevus; * (5) serious comorbidities, such as heart disease, epilepsy, high blood pressure and liver or kidney disease; * (6) Plan to become pregnant or breastfeed during the study period, or less than 6 months after delivery; * (7) Have a history of bleeding and clotting, or long-term use of anticoagulation and antiplatelet drugs (aspirin ≤81mg daily is not excluded); * (8) Suffering from autoimmune diseases; * (9) have an immunosuppressive disease such as AIDS, or an impaired immune system caused by the use of immunosuppressive drugs (investigators' judgment); * (10) Subjects with a history of heat-stimulated disease, such as recurrent herpes simplex in the treatment area, should only be treated after a pre-prevention regimen; * (11) Poor control of diseases related to the endocrine system as determined by the investigator, such as diabetes or thyroid dysfunction; * (12) Any active condition in the treatment area identified by the investigator, such as ulcers, eczema, or other skin lesions; * (13) A history of skin diseases, such as keloid, abnormal wound healing, psoriasis, etc.; * (14) Any invasive or non-invasive treatment (such as hair removal, light rejuvenation, microneedles or chemical exfoliation, etc.) in the treated area within 3 months prior to treatment; * (15) Received RF microneedle therapy, injection of fillers or botulinum toxin within 6 months prior to treatment; * (16) Receive semi-permanent fillers (poly-l-lactic acid, calci-hydroxy-phospholite, etc.) within 24 months before treatment; * (17) Have undergone facial medical or cosmetic surgery (e.g. eyelid/eyebrow surgery, periorbital or perioral soft tissue enhancement, permanent fillers, permanent makeup, tattoos, etc.); * (18) Use of drugs that may trigger photosensitization during the study period (such as quinolones, aspirin, hyd rochlorothiazide or furosemide); * (19) Use of any medications that affect skin characteristics (e.g., vitamin A, steroids, thyroid medications, etc.) in the past 6 months; * (20) Participate in a clinical trial of another drug or device in which the last treatment of the investigational drug/device occurred 3 months before the start of treatment in the study; * (21) Plan to change previously used skin care products during the study period; * (22) Other conditions deemed unsuitable for inclusion by the researcher. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Guangzhou **Country:** China **Facility:** The Third Affiliated Hospital of Sun Yat-sen University **State:** Guangdong **Zip:** 510000 #### Overall Officials **Official 1:** **Affiliation:** Third Affiliated Hospital, Sun Yat-Sen University **Name:** Wei Lai, Doctor **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## 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: M21089 - Name: Facies - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441786 **Brief Title:** A Metacognitive Group Therapy of Depression and Anxiety in Youth With Autism **Official Title:** A Metacognitive Group Therapy of Depression and Anxiety in Youth With Autism: Feasibility, Acceptability and Effect in a Clinical Open Trial #### Organization Study ID Info **ID:** UUMCT001 #### Organization **Class:** OTHER **Full Name:** Uppsala University ### Status Module #### Completion Date **Date:** 2025-08-29 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-08-29 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-12 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-28 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Uppsala University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this open clinical trial is to try out and evaluate a group metacognitive treatment protocol, for adolescents aged 15-18 years of age with anxiety and/or depression and an autism diagnosis. The main questions it aims to answer are: 1. How does the recruitment to the study work and what is the retention rate? 2. What is the level of participant compliance? 3. Is the treatment adherence satisfactory, are there any practical problems with treatment delivery? 4. Are the outcome measures and assessment procedures feasible? 5. Do the participants accept the treatment, are there any reports of adverse effects? 6. What are the preliminary effects of the treatment regarding 1. Symptoms of anxiety and/or depression 2. Quality of life 3. Functional impairment 4. Subjective level of stress 5. Central metacognitive processes 7. Are changes in metacognitive processes related to changes in anxiety and depression? The participants will partake in metacognitive group treatment of 10 sessions following an initial screening. **Detailed Description:** Participants in the study are youth (15 to 18 years of age) seeking help for anxiety and depression within child and youth psychiatry. There will a consecutive inclusion to form 6 treatment groups with 6 persons in each. The groups will meet once every week. Assessments will take place at pre- and post-treatment as well as at 6-month follow-up. Some metacognitive processes will also be monitored at each group session. The therapists have undergone a specialist training in metacognitive therapy and are experienced in using the methods. The main focus of the study is on feasibility, acceptability and preliminary effects of the treatment. These will be analyzed with paired sample t-test on primary and secondary outcomes. ### Conditions Module **Conditions:** - Anxiety Depression ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** A clinical open trial evaluating feasibility, acceptability, as well as treatment effects measured before, after and at 6-month follow-up, for a 10-week group treatment based on metacognitive therapy, for adolescents aged 15-18 years of age with anxiety and/or depression and an autism diagnosis. The study is conducted at two psychiatric clinics for children and youth. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A within group design where one clinical manualized intervention, Metacognitive therapy (MCT) for anxiety and depression, is offered in a 10-session group format to adolescents. The therapists have received special training in MCT and are experienced in using the methods. The treatment is delivered face-to-face. **Intervention Names:** - Behavioral: A metacognitive group therapy of depression and anxiety in youth with autism **Label:** A metacognitive group therapy of depression and anxiety in youth with autism **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - A metacognitive group therapy of depression and anxiety in youth with autism **Description:** The treatment model is based on Adrian Wells' transdiagnostic A-M-C model and treatment structure described in Wells (2009) "Metacognitive therapy for anxiety and depression". The group treatment is delivered in 10 weekly sessions. **Name:** A metacognitive group therapy of depression and anxiety in youth with autism **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** A self-report measuring negative effects of the treatment and some aspects related to acceptability. **Measure:** Negative Effects Questionnaire, 20 items Child (NEQ 20C) **Time Frame:** After treatment completion at 10 weeks. #### Primary Outcomes **Description:** A self-report that measures symptoms of anxiety and depression. **Measure:** Revised Children's Anxiety and Depression Scale (RCADS) **Time Frame:** Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up #### Secondary Outcomes **Description:** A self-report measuring experienced quality of life. **Measure:** Brunnsviken Brief Quality of life questionnaire (BBQ) **Time Frame:** Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up **Description:** A self-report measuring metacognitive assumptions and processes. **Measure:** Metacognitions Questionnaire - 30 items version (MCQ-30) **Time Frame:** Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up **Description:** A self-report measuring the presence of Cognitive Attentional Syndrome **Measure:** Cognitive Attentional Syndrome Scale (CAS-1) **Time Frame:** Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up **Description:** A subjective appraisal of functional impairment related to familial, social and vocational aspects of life. **Measure:** Child Sheehan Disability Scale (CSDS) **Time Frame:** Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up **Description:** A self-report measuring subjective stress. **Measure:** Perceived Stress Scale 10 (PSS-10) **Time Frame:** Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age of 15 to 18 years * Seeking medical care PRIMA psychiatric clinic for children and youth in Stockholm * Diagnoses of anxiety disorder or depression as well as autism established in a clinical interview * Mastering the Swedish language enough to take part of the treatment * Willingness/ability to participate after receiving information about what participation entails Exclusion Criteria: * Assessed to meet one of the following diagnoses: Bipolar syndrome, alcohol use syndrome, substance use syndromes, psychotic symptoms and affective syndromes with psychotic symptoms and antisocial personality disorder. * Assessed to have a high suicide risk. * Assessed to have extensive self-harm behavior or moderate to high risk of such. * Participating in other psychological treatment or about to start such treatment during the time interval of the study. * Has not had stable medication in the last month or is planning a deposit/medication adjustment during the time interval of the study. **Maximum Age:** 18 Years **Minimum Age:** 15 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Timo Hursti, Ph.D. **Phone:** +46184717842 **Role:** CONTACT #### Locations **Location 1:** **City:** Haninge **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Markus Björnström - **Role:** CONTACT **Country:** Sweden **Facility:** PRIMA Child and Youth Psychiatry, Handen **State:** Stockholm **Zip:** 13640 #### Overall Officials **Official 1:** **Affiliation:** Uppsala University **Name:** Timo Hursti, Ph.D. **Role:** PRINCIPAL_INVESTIGATOR ## 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 ### 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: M4623 - Name: Autistic Disorder - Relevance: LOW - As Found: Unknown - ID: M4324 - Name: Anxiety Disorders - Relevance: HIGH - As Found: Anxiety - 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 ### Condition Browse Module - Meshes - ID: D000003863 - Term: Depression - ID: D000003866 - Term: Depressive Disorder - ID: D000001008 - Term: Anxiety Disorders ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441773 **Acronym:** REHABIM **Brief Title:** Impact of Respiratory Rehabilitation on Quality of Life in Patients With Metastatic Non-small Cell Lung Cancer Treated With Immunotherapy and Chemotherapy in the Maintenance Phase **Official Title:** Impact of Respiratory Rehabilitation on Quality of Life in Patients With Metastatic Non-small Cell Lung Cancer Treated With Immunotherapy and Chemotherapy in the Maintenance Phase #### Organization Study ID Info **ID:** 29BRC22.0255 #### Organization **Class:** OTHER **Full Name:** University Hospital, Brest #### Secondary ID Infos **Domain:** IDRCB **ID:** 2023-A02162-43 **Type:** REGISTRY ### Status Module #### Completion Date **Date:** 2024-11-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-11-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-11-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Brest #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Lung cancer is highly prevalent, with approximately 46,363 new cases in 2018, accounting for 20.6% of cancer deaths in France. At diagnosis, 70% of patients have advanced or metastatic cancer, treatable only by palliative care. Respiratory rehabilitation aims to reduce symptoms, enhance performance, increase autonomy, and improve patients\&amp;#39; quality of life. While effective for COPD patients and other conditions causing dyspnea, its benefits in advanced, non-operable lung cancer are less studied. Some studies have shown the feasibility and safety of respiratory rehabilitation, but few have compared its impact on non-operable lung cancer patients or assessed its effect on quality of life. The main objective of the proposed study is to evaluate the impact of a respiratory rehabilitation program on the quality of life of patients with non-small cell lung cancer (NSCLC) undergoing maintenance chemotherapy and immunotherapy, compared to a control group receiving standard care. **Detailed Description:** Lung cancer accounts for an estimated 46,363 new cases in 2018. At the time of diagnosis, 70% of patients have locally advanced or metastatic cancer that can no longer be treated by surgery, but only by palliative therapy. It is the 4th most common cancer in France, and the most common worldwide. Lung cancer accounts for 20.6% of all cancer deaths in France. Respiratory rehabilitation aims to minimize symptoms linked to the underlying pathology, and to enhance performance, increase autonomy and promote activities of daily living. It also aims to improve health-related quality of life and long-term maintenance of behavioral changes. It has been shown to be effective for COPD patients. Respiratory rehabilitation has also demonstrated its benefits in other pathologies whose common denominator is dyspnea, such as interstitial lung disease and pulmonary hypertension. In the case of operable lung cancers, numerous studies have focused on the preoperative and postoperative benefits. Very few studies have focused on its benefits in advanced, non-operable lung cancer. The team of Olivier et al. studied the benefits of home respiratory rehabilitation for 8 weeks in patients with advanced or metastatic lung cancer or mesothelioma treated with concomitant chemotherapy. Their study shows feasibility and safety for patients who complete the program, but the authors point out that the absence of a control arm and the small number of patients mean that the benefits of respiratory rehabilitation cannot be confirmed. The team of Edbrooke et al., in 2019, is studying the value of a home-based rehabilitation program. The aim of the study is to demonstrate the efficacy of respiratory rehabilitation compared with standard care, a randomized controlled superiority trial. The study showed no statistically significant difference at 9 weeks on the primary endpoint (the 6-min walk test), due to a lack of power in the trial. A final study (Park et al.) showed the feasibility of outpatient rehabilitation in twelve patients, but did not conclude on the value of respiratory rehabilitation. Thus, while a few studies have demonstrated the feasibility of respiratory rehabilitation in patients with bronchial cancer, few comparative studies have evaluated the impact of rehabilitation in patients with non-operable bronchial cancer, and no study has assessed the impact of respiratory rehabilitation on quality of life (as a primary endpoint), although this would appear to be an essential element in the care of these patients. The main objective of our study is to evaluate the impact of a respiratory rehabilitation program (rehabilitation group) in patients with non-small cell lung cancer (NSCLC) treated with chemotherapy and immunotherapy in the maintenance phase compared with patients with NSCLC treated with chemotherapy and immunotherapy in the maintenance phase (control group), on quality of life at 2 months (8 weeks). ### Conditions Module **Conditions:** - Cancer **Keywords:** - Respiratory rehabilitation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** A two-center, randomized, open-label, parallel-group, ratio-distributed (1:1) trial comparing the impact of respiratory rehabilitation (RR) on quality of life at 2 months in patients with advanced NSCLC associated with RR versus patients with advanced NSCLC without RR. ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 84 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Maintenance of chemotherapy and immunotherapy alone: without respiratory rehabilitation (control group) **Label:** Control **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Maintenance of chemotherapy and immunotherapy combined with a respiratory rehabilitation program of 2 sessions per week for 8 weeks (respiratory rehabilitation group) = 16 sessions **Intervention Names:** - Procedure: Respiratory Rehabilitation **Label:** Respiratory rehabilition **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Respiratory rehabilition **Description:** An initial assessment is conducted upon admission to personalize the program. This includes: Clinical examination Spirometry Maximum Inspiratory Pressure (PImax) measurement Multidimensional Dyspnea Profile questionnaire at end of TM6 Exercise Functional Testing Measurement of quadriceps strength and endurance Blood gases Educational interview and shared educational assessment London Chest Activity of Daily Living (LCADL) Tobacco and/or dietary consultation The respiratory rehabilitation program, performed twice a week, includes: Exercise training on an ergocycle and treadmill (30 minutes at ventilatory threshold for the ergocycle; 30 minutes at 60-80% walking speed for the treadmill; or dyspnea rated 4-6 on the Borg scale after endurance exercise) Quadriceps muscle strengthening Therapeutic education program Group gymnastics Smoking cessation assistance Socio-psychological and nutritional support **Name:** Respiratory Rehabilitation **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The primary endpoint is the measurement of quality of life, assessed by the composite score from the sum of EORTC QLQ-C30. The evaluation will be conducted by filling out the quality of life questionnaires at inclusion (=Week 0) and at 8 weeks **Measure:** Quality of Life Measurement Using EORTC QLQ-C30 **Time Frame:** Week 0 **Description:** The primary endpoint is the measurement of quality of life, assessed by the composite score from the sum of EORTC QLQ-LC13. The evaluation will be conducted by filling out the quality of life questionnaires at inclusion (=Week 0) and at 8 weeks **Measure:** Quality of Life Measurement Using EORTC QLQ-LC13 **Time Frame:** Week 0 **Description:** The primary endpoint is the measurement of quality of life, assessed by the composite score from the sum of EORTC QLQ-C30. The evaluation will be conducted by filling out the quality of life questionnaires at inclusion (=Week 0) and at 8 weeks **Measure:** Quality of Life Measurement Using EORTC QLQ-C30 **Time Frame:** Week 8 **Description:** The primary endpoint is the measurement of quality of life, assessed by the composite score from the sum of EORTC QLQ-LC13. The evaluation will be conducted by filling out the quality of life questionnaires at inclusion (=Week 0) and at 8 weeks **Measure:** Quality of Life Measurement Using EORTC QLQ-LC13 **Time Frame:** Week 8 #### Secondary Outcomes **Description:** Quality of life measurement using the functional scales and symptom scales of the QLQ-C30 questionnaire. **Measure:** Evaluation of quality of life using multiple modalities of the QLQ-C30. **Time Frame:** Week 0 **Description:** Quality of life measurement using the functional scales and symptom scales of the QLQ-C30 questionnaire. **Measure:** Evaluation of quality of life using multiple modalities of the QLQ-C30. **Time Frame:** Week 8 **Description:** Quality of life measurement using the functional scales and symptom scales of the QLQ-C30 questionnaire. **Measure:** Evaluation of quality of life using multiple modalities of the QLQ-C30. **Time Frame:** Month 6 **Description:** Quality of life measurement using the functional scales and symptom scales of the QLQ-C30 questionnaire. **Measure:** Evaluation of quality of life using multiple modalities of the QLQ-C30. **Time Frame:** Month 12 **Description:** Quality of life measurement using the functional scales and symptom scales of the QLQ-C13 questionnaire. **Measure:** Evaluation of quality of life using multiple modalities of the QLQ-C13. **Time Frame:** Week 0 **Description:** Quality of life measurement using the functional scales and symptom scales of the QLQ-C13 questionnaire. **Measure:** Evaluation of quality of life using multiple modalities of the QLQ-C13 **Time Frame:** Week 8 **Description:** Quality of life measurement using the functional scales and symptom scales of the QLQ-C13 questionnaire. **Measure:** Evaluation of quality of life using multiple modalities of the QLQ-C13 **Time Frame:** Month 6 **Description:** Quality of life measurement using the functional scales and symptom scales of the QLQ-C13 questionnaire. **Measure:** Evaluation of quality of life using multiple modalities of the QLQ-C13 **Time Frame:** Month 12 **Description:** Quality of life measurement using the global health score of the QLQ-C30 at 6 months and 1 year. **Measure:** Evaluation of quality of life using the global health score of the QLQ-C30 **Time Frame:** Month 6 **Description:** Quality of life measurement using the global health score of the QLQ-C30 at 6 months and 1 year. **Measure:** Evaluation of quality of life using the global health score of the QLQ-C30 **Time Frame:** Month 12 **Description:** Evaluation of the number of deceased and surviving patients throughout the study follow-up. **Measure:** Evaluation of the number of deceased and surviving patients throughout the study follow-up. **Time Frame:** Week 8 **Description:** Evaluation of the number of deceased and surviving patients throughout the study follow-up. **Measure:** Evaluation of the number of deceased and surviving patients throughout the study follow-up. **Time Frame:** Month 6 **Description:** Evaluation of the number of deceased and surviving patients throughout the study follow-up. **Measure:** Evaluation of the number of deceased and surviving patients throughout the study follow-up. **Time Frame:** Month 12 **Description:** Measurement of median Progression-Free Survival (based on RECIST criteria = tumor response evaluation) throughout the study follow-up. **Measure:** Study of tumor response evaluation **Time Frame:** Week 8 **Description:** Measurement of median Progression-Free Survival (based on RECIST criteria = tumor response evaluation) throughout the study follow-up. **Measure:** Study of tumor response evaluation **Time Frame:** Month 6 **Description:** Measurement of median Progression-Free Survival (based on RECIST criteria = tumor response evaluation) throughout the study follow-up. **Measure:** Study of tumor response evaluation **Time Frame:** Month 12 **Description:** Measurement of exercise capacity using the 6-Minute Walk Test (6MWT) at Week 0 and at 8 weeks (after 16 sessions for the respiratory rehabilitation group) **Measure:** Evaluation of exercise capacity using 6-Minute Walk Test **Time Frame:** Week 0 **Description:** Measurement of exercise capacity using the 6-Minute Walk Test (6MWT) at Week 0 and at 8 weeks (after 16 sessions for the respiratory rehabilitation group) **Measure:** Evaluation of exercise capacity using 6-Minute Walk Test **Time Frame:** Week 8 **Description:** Evaluation of the number of events of interest **Measure:** Evaluation of the number of events of interest **Time Frame:** Week 8 **Description:** Evaluation of the number of events of interest **Measure:** Evaluation of the number of events of interest **Time Frame:** Month 6 **Description:** Evaluation of the number of events of interest **Measure:** Evaluation of the number of events of interest **Time Frame:** Month 12 **Description:** Number of hospitalizations other than for maintenance treatment **Measure:** Evaluation of the number of hospitalizations **Time Frame:** Week 8 **Description:** Number of hospitalizations other than for maintenance treatment **Measure:** Evaluation of the number of hospitalizations **Time Frame:** Month 6 **Description:** Number of hospitalizations other than for maintenance treatment **Measure:** Evaluation of the number of hospitalizations **Time Frame:** Month 12 **Description:** Measurement of anxiety and depressive disorders (HAD questionnaire) between Week 0 and Week 8 **Measure:** Evaluation of anxiety and depressive disorders **Time Frame:** Week 0 **Description:** Measurement of anxiety and depressive disorders (HAD questionnaire) between Week 0 and Week 8 **Measure:** Evaluation of anxiety and depressive disorders **Time Frame:** Week 8 **Description:** Evaluation of dyspnea (MMRC scale) at Week 0 and at 8 weeks **Measure:** Evaluation of dyspnea with mMRC scale **Time Frame:** Week 0 **Description:** Evaluation of dyspnea (MMRC scale) at Week 0 and at 8 weeks **Measure:** Evaluation of dyspnea with mMRC scale **Time Frame:** Week 8 **Description:** Evaluation of dyspnea (Dyspnea-12 questionnaire) at Week 0 and at 8 weeks **Measure:** Evaluation of dyspnea with Dyspnea-12 questionnaire **Time Frame:** Week 0 **Description:** Evaluation of dyspnea (Dyspnea-12 questionnaire) at Week 0 and at 8 weeks **Measure:** Evaluation of dyspnea with Dyspnea-12 questionnaire **Time Frame:** Week 8 **Description:** Evaluation of self-esteem (ISP-6 questionnaire) at Week 0 and at 8 weeks **Measure:** Evaluation of self-esteem with ISP-6 questionnaire **Time Frame:** Week 0 **Description:** Evaluation of self-esteem (ISP-6 questionnaire) at Week 0 and at 8 weeks **Measure:** Evaluation of self-esteem with ISP-6 questionnaire **Time Frame:** Week 8 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Histologically proven stage IV non-small cell lung cancer patient * First-line treatment with chemotherapy combined with immunotherapy in the maintenance phase * Adenocarcinoma patient: maintenance with Alimta combined with pembrolizumab * Squamous cell carcinoma patient: maintenance with pembrolizumab alone * Age of at least 18 years * Performance status of 0 or 1 * Estimated life expectancy \> 12 weeks * No contraindications to respiratory rehabilitation * Adequate organ function, demonstrated by laboratory results within the last 3 weeks, allowing maintenance treatment: * Normal liver function: bilirubin \< 1.5 x ULN, ALT and AST \< 2.5 x ULN or \< 5 x ULN in the case of liver metastases. * Renal function (creatinine clearance calculation of at least \> 45 mL/min). * Hematological function: absolute neutrophil count \> 1.5 x 10\^9/L and/or platelets \> 100 x 10\^9/L, hemoglobin \> 8 g/dL. * Informed consent to participate in the study must be signed * Patient must be affiliated with or beneficiary of social security Exclusion Criteria: * Small cell lung cancer, mesothelioma, neuroendocrine lung cancer * Patients with orthopedic disorders preventing respiratory rehabilitation that, in the investigator's opinion, could interfere with respiratory rehabilitation * Unresolved toxicity from previous treatment of grade \> 1 (except alopecia) that, in the investigator's opinion, could interfere with respiratory rehabilitation * Symptomatic brain metastases (corticosteroid treatment is allowed if the doses administered are stable for at least one month before inclusion) * Bone metastases preventing respiratory rehabilitation * Contraindication to respiratory rehabilitation * Uncontrolled infection * Pregnancy and breastfeeding * Surgery within two months prior to inclusion that could interfere with respiratory rehabilitation * Persons under legal protection (guardianship or curatorship) or deprived of liberty **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Florence Jacquemine Péguet-Ménard **Phone:** 06.23.25.64.50 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441760 **Acronym:** R01 **Brief Title:** Simulation Trial of Telemedical Support for Paramedics **Official Title:** Efficacy of Teleconsultation to Improve Prehospital Patient Safety for Critically Ill Infants and Children - A Multicenter, Simulation-based Randomized Control Trial #### Organization Study ID Info **ID:** H-44972 #### Organization **Class:** OTHER **Full Name:** Boston Medical Center ### Status Module #### Completion Date **Date:** 2028-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) #### 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:** In the United States, the current standard of prehospital (i.e. outside of hospitals) emergency care for children with life-threatening illnesses in the community includes remote physician support for paramedics providing life-saving therapy while transporting the child to the hospital. Most prehospital emergency medical services (EMS) agencies use radio-based (audio only) communication between paramedics and physicians to augment this care. However, this communication strategy is inherently limited as the remote physician cannot visualize the patient for accurate assessment and to direct treatment. The purpose of this pilot randomized controlled trial (RCT) is to evaluate whether use of a 2-way audiovisual connection with a pediatric emergency medicine expert (intervention = "telemedical support") will improve the quality of care provided by paramedics to infant simulator mannequins with life threatening illness (respiratory failure). Paramedics receiving real-time telemedical support by a pediatric expert may provide better care due to decreased cognitive burden, critical action checking, protocol verification, and error correction. Because real pediatric life-threatening illnesses are rare, high stakes events and involve a vulnerable population (children), this RCT will test the effect of the intervention on paramedic performance in simulated cases of pediatric medical emergencies. The two specific aims for this research are: * Aim 1: To test the intervention efficacy by determining if there is a measurable difference in the frequency of serious safety events between study groups * Aim 2: To compare two safety event detection methods, medical record review, and video review ### Conditions Module **Conditions:** - Pediatric Emergencies - Cardiopulmonary Arrest - Acute Respiratory Failure - Status Epilepticus **Keywords:** - Prehospital emergency care - Emergency medical services (EMS) - Paramedics - Infant simulator mannequins - Telemedical support - Critically ill infants and children ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Single blind, parallel arm, multicenter simulation RCT of prehospital teams from 9 Pediatric Emergency Care Applied Research Network (PECARN) and non-PECARN sites ##### Masking Info **Masking:** SINGLE **Masking Description:** All participants will be blinded to the simulated transport scenarios. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 420 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Emergency Medical Services (EMS) providers randomized into this arm will receive video teleconsultation with Pediatric Emergency Medicine (PEM) physicians. **Intervention Names:** - Other: Video teleconsultation **Label:** Teleconsultation video arm with PEM physicians **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** EMS providers randomized into this arm will receive audio support by usual care Emergency Medicine (EM) physicians. **Intervention Names:** - Other: Audio support **Label:** Audio support arm with EM physicians **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Teleconsultation video arm with PEM physicians **Description:** Each team will participate in 4 video-recorded simulated transports in fully equipped ambulances. Each team will provide resuscitative care in 4 simulated high-risk pediatric transports. EMS personnel will provide care in the ambulance while PEM physicians will provide medical direction remotely using video to communicate with EMS personnel via tablet devices. **Name:** Video teleconsultation **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Audio support arm with EM physicians **Description:** Each team will participate in 4 video-recorded simulated transports in fully equipped ambulances. Each team will provide resuscitative care in 4 simulated high-risk pediatric transports. EMS personnel will provide care in the ambulance while EM physicians will provide medical direction remotely using audio to communicate with EMS personnel via tablet devices. **Name:** Audio support **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Serious safety events are defined as clinical care actions that reach the patient and have the potential to cause moderate-to-severe harm or death. An investigator developed predefined serious safety event checklist developed for each simulated transport scenario will be used to record serious safety events. Serious safety events will be scored as: present, absent, or not observable. **Measure:** Number of Serious Safety Events **Time Frame:** Post treatment usually 4 hours #### Secondary Outcomes **Description:** The composite team performance score is calculated from the modified Lammer's simulation checklist tool as the percentage of completed actions that can be observed during the simulation by either video review or in person observation. This checklist tool contains 171 items across 3 simulated transport scenarios that represent critical actions expected for optimal care performance. **Measure:** Composite team score **Time Frame:** Post treatment usually 4 hours **Description:** Errors in medication choice are measured by specific items within the modified Lammer's simulation checklist tool. These will be any incorrect type of medication used by a team during simulation, including unanticipated medication choices which raters feel was not indicated or potentially harmful by consensus opinion. This will be reported as the proportion or percentage of items scored as incomplete over all possible items related to medication choice. **Measure:** Error in medication choice **Time Frame:** Post treatment usually 4 hours **Description:** These are measured by specific items within modified Lammer's simulation checklist tool. These will be any error in pediatric weight-based dose calculation, including error in volume of administered drug. This will be reported as the proportion or percentage of items scored as incomplete over all possible items related to weight-based medication dosing. **Measure:** Error in weight-based medication dosing **Time Frame:** Post treatment usually 4 hours **Description:** These are measured by specific items within the modified Lammer's simulation checklist tool. These will be any error in size of equipment used during each case. This will be reported as the proportion or percentage of items scored as incomplete over all possible items related to equipment sizing **Measure:** Equipment size error **Time Frame:** Post treatment usually 4 hours **Description:** These are measured by specific items within the modified Lammer's simulation checklist tool. These will be any error observed omission, error, or deviation in offline and online EMS treatment protocols that could result in patient harm. This will be reported as the proportion or percentage of items scored as incomplete over all possible items related to selection of appropriate EMS protocols. **Measure:** EMS protocol error **Time Frame:** Post treatment usually 4 hours **Description:** These are measured by specific items within the modified Lammer's simulation checklist tool. These will be any error in equipment usage during each case. This will be reported as the proportion or percentage of items scored as incomplete over all possible items related to equipment use. **Measure:** Equipment Use Error **Time Frame:** Post treatment usually 4 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Certified Emergency Medical Technicians (EMTs), Advanced EMTs (AEMTs), and Paramedics (EMT-Ps) who provide direct scene response. * Board-certified Pediatric Emergency Medicine (PEM) and Emergency Medicine (EM) physicians whose practice includes online medical support for EMS are eligible. * The control arm will include physicians who provide radio/telephone support in usual care at each site. In the intervention arm, experts will be PEM with/without EMS board-certification as they have relevant pediatric training and experience. Exclusion Criteria: * EMS personnel providing interfacility transport and/or pediatric specialty transport * Resident physicians-in-training * Non-physician providers **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Tehnaz Boyle, MD PhD **Phone:** 617-414-3682 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Divya Gumudavelly, MPH **Phone:** 248-787-0876 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Bosotn Medical Center, Pediatrics Department **Name:** Tehnaz Boyle, 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: D000012120 - Term: Respiration Disorders - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000012640 - Term: Seizures - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14968 - Name: Respiratory Insufficiency - Relevance: HIGH - As Found: Respiratory Failure - ID: M9411 - Name: Heart Arrest - Relevance: HIGH - As Found: Cardiopulmonary Arrest - ID: M7796 - Name: Emergencies - Relevance: HIGH - As Found: Emergency - ID: M16018 - Name: Status Epilepticus - Relevance: HIGH - As Found: Status Epilepticus - ID: M19010 - Name: Critical Illness - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - 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: M15452 - Name: Seizures - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T5471 - Name: Status Epilepticus - Relevance: HIGH - As Found: Status Epilepticus ### Condition Browse Module - Meshes - ID: D000012131 - Term: Respiratory Insufficiency - ID: D000013226 - Term: Status Epilepticus - ID: D000006323 - Term: Heart Arrest - ID: D000004630 - Term: Emergencies ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441747 **Brief Title:** Phase II Study of the Combination of Durvalumab (MEDI4736) (PDL1 Inhibitor) and Olaparib (PARP Inhibitor) in Advanced Cholangiocarcinoma After Initial Chemotherapy and Durvalumab (BIL-PPP) **Official Title:** Phase II Study of the Combination of Durvalumab (MEDI4736) (PDL1 Inhibitor) and Olaparib (PARP Inhibitor) in Advanced Cholangiocarcinoma After Initial Chemotherapy and Durvalumab (BIL-PPP) #### Organization Study ID Info **ID:** BIL-PPP #### Organization **Class:** NETWORK **Full Name:** Australasian Gastro-Intestinal Trials Group ### Status Module #### Completion Date **Date:** 2028-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-08 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Wayne Elphinstone Research Fund **Class:** INDUSTRY **Name:** AstraZeneca #### Lead Sponsor **Class:** NETWORK **Name:** Australasian Gastro-Intestinal Trials Group #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The aim of this study is to investigate whether the combination of durvalumab and olaparib in the maintenance setting after initial chemotherapy and durvalumab will benefit patients with locally advanced or metastatic cholangiocarcinoma. **Detailed Description:** The primary objectives are (i) To describe the efficacy of PARPi and PDL1 inhibition in the maintenance setting of metastatic cholangiocarcinomas. (ii) To refine selection of the patient population who are most likely to benefit from the combination of PDL1 (Durvalumab) and PARP (Olaparib) inhibition in the maintenance setting following initial chemotherapy (cisplatin + gemcitabine + Durvalumab) (post hoc translational analysis). The secondary objectives are (i) To evaluate toxicity of the combination of durvalumab and olaparib. (ii) To evaluate progression-free and overall survival with the combination of durvalumab and olaparib (PFS, OS). ### Conditions Module **Conditions:** - Cholangiocarcinoma **Keywords:** - Advanced Cholangiocarcinoma ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This is a trial of Durvalumab in combination with olaparib. Durvalumab will be administered at a dose of 1500mg intravenously every 4 weeks. Olaparib will be administered orally at a dose of 300mg twice daily continuously. This combination will be administered for a maximum of two years unless unacceptable toxicities or progressive disease. **Intervention Names:** - Drug: Durvalumab - Drug: Olaparib **Label:** Durvalumab and Olaparib **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Durvalumab and Olaparib **Description:** Durvalumab will be administered at a dose of 1500mg intravenously every 4 weeks. **Name:** Durvalumab **Other Names:** - Imfinzi **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Durvalumab and Olaparib **Description:** Olaparib is administered at a dose of 300mg bd in a continuous 28-day cycle. On day 1 of each cycle, the morning dose of Olaparib should be taken no more than 1 hour prior to infusion of durvalumab. It is expected that patients will receive up to 24 months of a combination of olaparib and durvalumab, or until disease progression, unacceptable toxicities, or withdrawal of consent. **Name:** Olaparib **Other Names:** - Lynparza **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** To describe the efficacy of PARPi and PDL1 inhibition in the maintenance setting of metastatic cholangiocarcinomas. **Measure:** Primary Objective **Time Frame:** 12 months post randomisation **Description:** To refine selection of the patient population who are most likely to benefit from the combination of PDL1 (durvalumab) and PARP (olaparib) inhibition in the maintenance setting following initial chemotherapy (cisplatin + gemcitabine + durvalumab) (post hoc translational analysis). **Measure:** Evaluate benefit **Time Frame:** 12 months post randomisation #### Secondary Outcomes **Description:** To evaluate toxicity of the combination of durvalumab and olaparib. **Measure:** Evaluate toxicity **Time Frame:** 12 months post randomisation **Description:** To evaluate progression-free survival with the combination of durvalumab and olaparib (PFS). **Measure:** Progression free survival **Time Frame:** 12 months post randomisation **Description:** To evaluate overall survival with the combination of durvalumab and olaparib (OS). **Measure:** Overall survival **Time Frame:** 12 months post randomisation ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age ≥18 years, and life expectancy\>12 weeks 2. Weight: \>30kg 3. Histologically proven locally advanced or metastatic/unresectable cholangiocarcinoma 4. Documentation of RECISTv1.1 measurable disease 5. Must not have had radiologic progression after 6-8 cycles of gemcitabine and cisplatin and durvalumab 6. Adequate haematological and end-organ function as defined by the following parameters: 1. Haemoglobin ≥ 90g/L (without a transfusion in the past two weeks) 2. Platelets ≥100 x 109/L (without a transfusion in the past two weeks) 3. Neutrophils ≥ 1.0 x 109/L (without the use of G-CSF in the 4 weeks prior to first dose) 4. ALT/AST \<3x ULN irrespective of presence of liver metastases 5. Serum bilirubin ≤ 1.5x ULN except in cases of known Gilbert's Syndrome where total bilirubin must be \<4x ULN 6. Albumin ≥ 25 g/L 7. Serum Creatinine ≤1.5 x ULN or eGFR ≥ 30mL/min/1.73m2 as calculated by Cockcroft Gault Equation 7. Able to swallow oral medications without any difficulties or medical history associated with malabsorption or any conditions that may impact on compliance or absorption of the study treatment. 8. Women of Childbearing potential must be either totally abstinent or agree to use at least one highly effective method of birth control (e.g., oral contraceptive pill, barrier method) for the duration of the study and for at least 6 months after the final dose of study medication. They must also have a negative serum beta-hCG in the 7 days prior to first dose of study drug. 9. Non-sterile males and their female partners must also either be totally abstinent or agree to use at least one highly effective method of birth control (e.g., oral contraceptive pill, barrier method) for the duration of the study and for at least 6 months after the final dose of study medication. 10. Patient is willing and able to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations including follow up. 11. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations. Exclusion Criteria: 1. Previous use of a PARP inhibitor. 2. All prior treatment-related AEs must have resolved to a CTCAE v5 Grade 1 or less prior to commencement of study medication, with the exception of alopecia and peripheral neuropathy which can be grade 2 or less. i. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician. ii. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or olaparib may be included only after consultation with the Study Chairs. 3. Known symptomatic or progressive CNS metastases or leptomeningeal disease. Patients with treated brain metastases are eligible for inclusion in the study if they had received treatment \>4 weeks prior to commencement of study medication, and have a repeat MRI scan demonstrating stability in disease. 4. Patients with severe chronic or active infections requiring systemic antibiotics or antifungals in the two weeks prior to starting trial treatment. 5. Any of the following cardiovascular risk factors: 1. Acute myocardial infarction (MI) ≤6 months prior to study registration 2. New York Heart Association (NYHA) Heart Failure Class III-IV within ≤6 months of registration 3. History of cerebral vascular accident (CVA) within 6 months of first dose 6. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study, or during the follow-up period of an interventional study. 7. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug. 8. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable. 9. History of allogeneic organ transplantation. 10. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion: 1. Patients with vitiligo or alopecia. 2. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement. 3. Any chronic skin condition that does not require systemic therapy. 4. Patients without active disease in the last 5 years may be included but only after consultation with the study physician. 5. Patients with celiac disease controlled by diet alone. 11. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent. 12. History of another primary malignancy except for: 1. Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of IP and of low potential risk for recurrence. 2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. 3. Adequately treated carcinoma in situ without evidence of disease. 13. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart). 14. History of active primary immunodeficiency. 15. Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of anti HBc and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. 1. Participants co-infected with HBV and HCV, or co-infected with HBV and HDV, namely: HBV positive (presence of HBsAg and/or anti HBcAb with detectable HBV DNA); AND 2. HCV positive (presence of anti-HCV antibodies); OR 3. HDV positive (presence of anti-HDV antibodies). 16. Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice). Known HIV infection that is not well controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA load for 6 months prior, CD4+ count of \>500, no history of AIDS-defining opportunistic infection within the past 12 months, and stable for at least 6 months on the same anti-HIV medications. 17. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion: 1. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection) 2. Systemic corticosteroids at physiologic doses that do not exceed 10 mg/day of prednisolone or its equivalent. 3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) 18. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 90days after the last dose of IP.19. Female patients who are pregnant or breastfeeding, or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy. 20. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients. 21. Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Sukanya Sathyamurthie **Phone:** +61 2 7208 2719 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Miriam Roesner **Phone:** +61 7208 2727 **Role:** CONTACT #### Locations **Location 1:** **City:** Camperdown **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Sara Wahlroos - **Phone:** 0285140362 - **Role:** CONTACT ***Contact 2:*** - **Name:** Sara Wahlroos - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Australia **Facility:** Chris O'Brien Lifehouse **State:** New South Wales **Zip:** 2050 **Location 2:** **City:** Clayton **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Marion Harris - **Phone:** 0385722392 - **Role:** CONTACT ***Contact 2:*** - **Name:** Marion Harris - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Australia **Facility:** Monash Medical Centre **State:** New South Wales **Zip:** 3168 **Location 3:** **City:** Westmead **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Adnan Nagrial - **Phone:** 0403170371 - **Role:** CONTACT ***Contact 2:*** - **Name:** Adnan Nagrial - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Australia **Facility:** Westmead Hospital **State:** New South Wales **Zip:** 2145 **Location 4:** **City:** Wollongong **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Lorraine Chantrill - **Phone:** 0242225260 - **Role:** CONTACT ***Contact 2:*** - **Name:** Lorraine Chantrill - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Australia **Facility:** Wollongong Hospital **State:** New South Wales **Zip:** 2500 **Location 5:** **City:** Brisbane **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Matthew Burge - **Phone:** (07) 3636 8111 - **Role:** CONTACT ***Contact 2:*** - **Name:** Matthew Burge - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Australia **Facility:** Royal Brisbane Women's Hospital **State:** Queensland **Zip:** 4006 **Location 6:** **City:** Woolloongabba **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Laura Tam - **Phone:** 0413959140 - **Role:** CONTACT ***Contact 2:*** - **Name:** Laura Tam - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Australia **Facility:** Princess Alexandra Hospital **State:** Queensland **Zip:** 4102 **Location 7:** **City:** Bedford Park **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Amitesh Roy, Dr - **Phone:** 0406768463 - **Role:** CONTACT ***Contact 2:*** - **Name:** Amitesh Roy - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Australia **Facility:** Flinders Medical Centre **State:** South Australia **Location 8:** **City:** Melbourne **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Niall Tebbutt - **Phone:** 0394965763 - **Role:** CONTACT ***Contact 2:*** - **Name:** Niall Tebbutt - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Australia **Facility:** Austin Health **State:** Victoria **Zip:** 3084 **Location 9:** **City:** Saint Albans **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Lara Lipton - **Phone:** 0383456537 - **Role:** CONTACT ***Contact 2:*** - **Name:** Lara Lipton - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Australia **Facility:** Western Health **State:** Victoria **Zip:** 3021 **Location 10:** **City:** Perth **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Andrew Dean - **Phone:** 0864659200 - **Role:** CONTACT ***Contact 2:*** - **Name:** Andrew Dean - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Australia **Facility:** St John of God Hospital, Subiaco **State:** Western Australia ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000000230 - Term: Adenocarcinoma - ID: D000002277 - Term: Carcinoma - 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 - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M20426 - Name: Cholangiocarcinoma - Relevance: HIGH - As Found: Cholangiocarcinoma - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M5534 - Name: Carcinoma - 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: T755 - Name: Bile Duct Cancer - Relevance: HIGH - As Found: Cholangiocarcinoma ### Condition Browse Module - Meshes - ID: D000018281 - Term: Cholangiocarcinoma ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000067856 - Term: Poly(ADP-ribose) Polymerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M272500 - Name: Durvalumab - Relevance: HIGH - As Found: Docetaxel - ID: M233003 - Name: Olaparib - Relevance: HIGH - As Found: Irinotecan - ID: M205 - Name: Poly(ADP-ribose) Polymerase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000613593 - Term: Durvalumab - ID: C000531550 - Term: Olaparib ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441734 **Brief Title:** Iron Status in Autism Spectrum Disorders **Official Title:** Iron Status in Autism Spectrum Disorders in Children Attending Assiut Pediatric University Hospital #### Organization Study ID Info **ID:** anemia in autism #### Organization **Class:** OTHER **Full Name:** Assiut University ### Status Module #### Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-03 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-02 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-02 **Type:** ESTIMATED **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-06-03 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assiut University #### Responsible Party **Investigator Affiliation:** Assiut University **Investigator Full Name:** esraa hefzy shaker mostafa **Investigator Title:** principle investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** to evaluate the prevalence of iron deficiency anemia in group with autism spectrum disorders in comparison to normal children group ### Conditions Module **Conditions:** - Anemia, Iron Deficiency ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** OTHER #### Enrollment Info **Count:** 46 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Diagnostic Test: cbc serum ferritin serum iron **Label:** study group #### Arm Group 2 **Intervention Names:** - Diagnostic Test: cbc serum ferritin serum iron **Label:** control group ### Interventions #### Intervention 1 **Arm Group Labels:** - control group - study group **Description:** by using sample of blood to do cbc and serum ferritin and serum iron during 1year **Name:** cbc serum ferritin serum iron **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** by cbc serum ferritin serum iron **Measure:** iron status in autism spectrum disorders **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * children who are diagnosed with autism spectrum disorder according to DSM -V * not having infection inflammatory conditions chronic physical illness * children who are not receiving iron supplementation Exclusion Criteria: * age below 2 years and above 12 years * having an infection or inflammatory conditions chronic physical illness * receiving iron supplementation **Maximum Age:** 12 Years **Minimum Age:** 2 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD **Study Population:** children age from 2years to 12 years not having an infection or inflammatory conditions or physical illness ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** esraa hefzy shaker **Phone:** 01090930692 **Role:** CONTACT **Contact 2:** **Name:** emad eldeen mahmoud hammad, professor **Phone:** 01223559943 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Assiut University **Name:** khalaf abdelaal said, lecturer **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Al-Beltagi M. Autism medical comorbidities. World J Clin Pediatr. 2021 May 9;10(3):15-28. doi: 10.5409/wjcp.v10.i3.15. eCollection 2021 May 9. **PMID:** 33972922 #### See Also Links **Label:** Related Info **URL:** http://www.ncbi.nlm.nih.gov ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002659 - Term: Child Development Disorders, Pervasive - ID: D000065886 - Term: Neurodevelopmental Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000019189 - Term: Iron Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000000747 - Term: Anemia, Hypochromic - ID: D000000740 - Term: Anemia - ID: D000006402 - Term: Hematologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - 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: M4623 - Name: Autistic Disorder - Relevance: LOW - As Found: Unknown - ID: M206 - Name: Autism Spectrum Disorder - Relevance: HIGH - As Found: Autism Spectrum Disorder - ID: M20857 - Name: Anemia, Iron-Deficiency - Relevance: HIGH - As Found: Anemia, Iron Deficiency - ID: M2781 - Name: Iron Deficiencies - Relevance: HIGH - As Found: Iron Deficiency - ID: M4070 - Name: Anemia - 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 - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M21177 - Name: Iron Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M4077 - Name: Anemia, Hypochromic - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000018798 - Term: Anemia, Iron-Deficiency - ID: D000090463 - Term: Iron Deficiencies - ID: D000067877 - Term: Autism Spectrum Disorder ### 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:** NCT06441721 **Acronym:** Haemodialysis **Brief Title:** Vitamin B12 Status and Its Impact on Chronic Haemodialysis Patient **Official Title:** Vitamin b12 Deficency and Its Impact on Chronic Haemodialysis Patient and Its Effect on Anemia and Neuropathy #### Organization Study ID Info **ID:** Vitamin B12 and Haemodialysis #### Organization **Class:** OTHER **Full Name:** Assiut University ### Status Module #### Completion Date **Date:** 2025-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-06 **Type:** ESTIMATED **Last Update Submit Date:** 2024-06-04 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assiut University #### Responsible Party **Investigator Affiliation:** Assiut University **Investigator Full Name:** Afaf Bakry Amin Omer **Investigator Title:** Doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** To evaluate vitamin B12 level in haemodialysis patients and its impact on hematological and neurological manifestations **Detailed Description:** Vitamin B12 (cobalamin) is a water-soluble vitamin involved in several normal cellular functions (1). Vitamin B12 is required for the development, myelination, and function of the central nervous system; healthy red blood cell formation; and DNA synthesis (2- 4). Low levels of vitamin B12 have been associated with high concentrations of homocysteine (Hcy) and can lead to health complications (5). Hyperhomocysteinemia is an important risk factor for cardiovascular disease (6). Vitamin B12 and other B vitamins are involved in homocysteine metabolism, and researchers have hypothesized that supplementation with these micronutrients can reduce the risk of cardiovascular disease by lowering homocysteine levels (7, 8). Vitamin B12 deficiency is one of the causes of Macrocytic anaemia with increased mean corpuscular volume (MCV), defined as more than 100 fL, which is the hallmark of megaloblastic anaemia ### Conditions Module **Conditions:** - End Stage Renal Disease on Dialysis - Vitamin B 12 Deficiency ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Measure vitamin b12 in serum and its impact on Haemodialysis patient **Name:** Vitamin b12 measure **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** vitamin b12 evaluation vitamin b12 evaluation **Measure:** vitamin b12 in serum **Time Frame:** one year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * End stage renal disease on haemodialysis pts. * Parients more than 18 years . * CKD patients controled group stage 3and stage 4. Exclusion Criteria: * Recent renal transplantation patients. * Patients on sulpha drugs. * Patients on methotrexate. * Patients on anticonvulsant. * Patients on chemotherap agent. * Patients on colchicine. * Patients on bile acid sequestrant. * Patients on h2blockers. * Patients on metformin. * Patients on proton pump inhibitors . * Diabetic patients. * Parients with history of intestinal surgery. * Patients diagnosed with malabsorption syndrome. * Patient on vitamin b12 intake. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** evaluate vitamin b12 in serum in chronic haemodialysis patient not diabetic age group 18-80 years ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Afaf bakry amin, Resident **Phone:** 01093626639 **Role:** CONTACT **Contact 2:** **Name:** Alaa Eldin Abd Elmoniem, supervisor **Phone:** 0106287922 **Role:** CONTACT ### References Module #### References **Citation:** Juszczak AB, Kupczak M, Konecki T. Does Vitamin Supplementation Play a Role in Chronic Kidney Disease? Nutrients. 2023 Jun 23;15(13):2847. doi: 10.3390/nu15132847. **PMID:** 37447174 **Citation:** Fahndrich C, Gemperli A, Baumberger M, Harder M, Roth B, Schaefer DJ, Wettstein R, Scheel-Sailer A. Risk factors of major complications after flap surgery in the treatment of stage III and IV pressure injury in people with spinal cord injury/disorder: a retrospective cohort study. Spinal Cord. 2024 Jan;62(1):34-41. doi: 10.1038/s41393-023-00944-9. Epub 2023 Dec 20. **PMID:** 38123748 #### See Also Links **Label:** Annual dialysis data report 2015 jsdt renal data **URL:** http://doi.org/10.1186/s41100-018-0149-8 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007674 - Term: Kidney 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: D000051436 - Term: Renal Insufficiency, Chronic - ID: D000051437 - Term: Renal Insufficiency - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000014804 - Term: Vitamin B Deficiency - ID: D000001361 - Term: Avitaminosis - ID: D000003677 - Term: Deficiency Diseases - ID: D000044342 - Term: Malnutrition - ID: D000009748 - Term: Nutrition Disorders ### 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: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M10699 - Name: Kidney Failure, Chronic - Relevance: HIGH - As Found: End Stage Renal Disease - ID: M17549 - Name: Vitamin B 12 Deficiency - Relevance: HIGH - As Found: Vitamin B12 Deficiency - ID: M4070 - Name: Anemia - Relevance: LOW - As Found: Unknown - 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: M26717 - Name: Renal Insufficiency, Chronic - 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: M4660 - Name: Avitaminosis - Relevance: LOW - As Found: Unknown - ID: M6879 - Name: Deficiency Diseases - Relevance: LOW - As Found: Unknown - ID: M25306 - Name: Malnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007676 - Term: Kidney Failure, Chronic - ID: D000014806 - Term: Vitamin B 12 Deficiency ### Intervention Browse Module - Ancestors - ID: D000014815 - Term: Vitamins - ID: D000018977 - Term: Micronutrients - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000014803 - Term: Vitamin B Complex - ID: D000006397 - Term: Hematinics ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Hemat - Name: Hematinics - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M17558 - Name: Vitamins - Relevance: LOW - As Found: Unknown - ID: M17546 - Name: Vitamin B Complex - Relevance: LOW - As Found: Unknown - ID: M9934 - Name: Hydroxocobalamin - Relevance: HIGH - As Found: Variant - ID: M17548 - Name: Vitamin B 12 - Relevance: HIGH - As Found: Variant - ID: M21009 - Name: Micronutrients - Relevance: LOW - As Found: Unknown - ID: M16885 - Name: Trace Elements - Relevance: LOW - As Found: Unknown - ID: M8618 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: M9485 - Name: Hematinics - Relevance: LOW - As Found: Unknown - ID: T441 - Name: Cobalamin - Relevance: HIGH - As Found: Variant - ID: T444 - Name: Cyanocobalamin - Relevance: HIGH - As Found: Variant - ID: T476 - Name: Vitamin B12 - Relevance: HIGH - As Found: Variant - ID: T451 - Name: Methylcobalamin - Relevance: HIGH - As Found: Variant - 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: D000014805 - Term: Vitamin B 12 - ID: D000006879 - Term: Hydroxocobalamin ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441708 **Brief Title:** Neutrophil Extracellular Traps (NETs) Mediated Killing of Carbapenem-resistant Pseudomonas Aeruginosa. **Official Title:** Neutrophil Extracellular Traps (NETs) Mediated Killing of Carbapenem-resistant Pseudomonas Aeruginosa Isolated From Hospital Acquired Infections in Assiut University Hospitals #### Organization Study ID Info **ID:** Pseudomonas aeruginosa #### Organization **Class:** OTHER **Full Name:** Assiut University ### Status Module #### Completion Date **Date:** 2025-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-03 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-06-03 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assiut University #### Responsible Party **Investigator Affiliation:** Assiut University **Investigator Full Name:** NSHussein **Investigator Title:** Assistant Lecturer at medical Microbilogy and Immunology department **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Aim of the work: To determine the killing ability of neutrophils to ATCC 27853, carbapenem-resistant P. aeruginosa. To compare between the ability of ATCC 27853, carbapenem-resistant P. aeruginosa to induce NETs formation. To quantify NETS formation in response to PMA, ATCC 27853, carbapenem-resistant P. aeruginosa using immunofluorescence. To determine the killing ability of NETs on ATCC 27853, carbapenem-resistant P. aeruginosa. **Detailed Description:** Pseudomonas aeruginosa is one of the most common pathogens in healthcare-associated infections worldwide, causing ventilator-associated pneumonia, urinary tract infections in patients with long-term urinary catheterization, wound infections, bloodstream infections, and otitis (reynolds and kollef, 2021). Carbapenem-resistant-P. aeruginosa infection is a prominent disease connected to healthcare due to multiple mechanisms, such as target alteration, active efflux, decreased permeability, and enzyme degradation (Tenover et al., 2022). Neutrophils are the most prominent cellular component of the innate immune response and are essential for defense against bacterial infections (Chapple et al., 2023). In addition to traditional antimicrobial processes of neutrophils, a unique web-like structure, is termed neutrophil extracellular traps (NETs), formed and released by highly active neutrophils. NETs consist of extracellular deoxyribonucleic acid (eDNA) filaments coated with histones and neutrophil granule proteins such as Myeloperoxidase (MPO), neutrophil elastase (NE), lactoferrin, cathepsins, calprotectin, LL-37, and defensin (Papayannopoulos, 2018). MPO and NE are key components of NETs and play roles in their function and structure. MPO, a heme protein primarily stored in the granules of neutrophils, contributes significantly to microbial killing within NETs. It catalyzes the production of hypochlorous acid from hydrogen peroxide and chloride ions, a reaction central to the antimicrobial properties of NETs. NE, another granule protein extends to modulating inflammation and immune response (Islam et al., 2023). The role of NETs during bacterial infection is not completely clear. It promoted the clearance of bacteria by facilitating the entrapping and killing of these pathogens, However, it has been described that the granular proteins released within the NETs act mainly as a regulator of inflammation due to the action on different cytokines, rather than as a bactericidal mechanism (Clancy, 2018). P. aeruginosa-mediated factors contribute to the NETosis and release of a large amount of NETs. However, sequestration of P. aeruginosa by traps does not lead to the complete destruction of bacteria, but, it promotes their microcolonization, aggregation, and finally biofilm formation, leading to the formation of higher resistance to NETs-mediated bactericidal activity (Rahman and Gadjeva, 2014). Neutrophils formed a NET-barrier to keep bacteria outside in the form of biofilm and prevent their spread to the brain. Thus, the NET formation is probably a useful mechanism for protecting the brain against infections through the ocular route (Thanabalasuriar et al., 2019). ### Conditions Module **Conditions:** - Neutrophil Extracellular Traps Formation ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** OTHER #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** No intervention on patient **Name:** No intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Quantitification of neutrophils extracellular traps by indirect immunofluroscrnce **Measure:** Quantitification of neutrophils extracellular traps by immunofluroscrnce **Time Frame:** Three months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * isolates will be isolated from different clinical samples including wound respiratory tract urine and blood. _carbapenem-resistant P. aeruginosa isolates. Exclusion Criteria: * _carbapenem-sensitive P. aeruginosa isolates. **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Clinical isolates from different clinical samples including urine, blood, sputum, wound ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Noura Samir Hussein, Assistant lecturer **Phone:** 00201002606302 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000016905 - Term: Gram-Negative Bacterial Infections - ID: D000001424 - Term: Bacterial Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000007239 - Term: Infections ### 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: M14409 - Name: Pseudomonas Infections - Relevance: HIGH - As Found: Pseudomonas - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M19249 - Name: Gram-Negative Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011552 - Term: Pseudomonas Infections ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441695 **Brief Title:** Acute Effects of PLT Health Solutions zümXR Extended-Release Caffeine **Official Title:** The Acute Effects of PLT Health Solutions zümXR Extended-Release Caffeine on Side Effects, Mood and Alertness Following a Night of Suboptimal Sleep #### Organization Study ID Info **ID:** Pro00078903 #### Organization **Class:** INDUSTRY **Full Name:** Applied Science & Performance Institute ### Status Module #### Completion Date **Date:** 2024-09-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-03 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Applied Science & Performance 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:** This will be a (2 visit) double-blind, randomized, crossover design clinical study to assess the potential benefits of ER-CAFF versus IR-CAFF by assessing its impact on side effect profiles, mood states, alertness, and cognitive abilities following ingestion after a suboptimal night of sleep. This study will enroll 30 healthy men and women who will be recruited by word of mouth, email contact, and direct contact from the greater Tampa Bay Area. To account for potential dropouts, we aim to enroll approximately 20% over the desired sample size (total of 36 participants). The anticipated study period will last approximately 2 weeks. After initial pre-screening, participants will report to the laboratory on two separate occasions after an overnight fast (10 hours minimum). Participants will be required to have a night of partial sleep deprivation the night before (\<5 hours sleep), which will be confirmed by self reported sleep logs and objective multisensor (triaxial accelerometry and cardiac data) wearable devices to accurately measure sleep deficit data. Upon arrival, participants will undergo baseline (BL) testing and then ingest a bolus of one study product with 4-8 ounces of water: 400 mg zümXR extended-release caffeine (ER-CAFF), or 400 mg of immediate-release caffeine anhydrous (IR-CAFF) (2 group, crossover design). Thereafter, participants will undergo subsequent testing sessions at 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation. After the 4-hour (240 min) measurements, a caffeine-free food bar will be provided. This same food bar will also be offered to participants following the final 7-hour (420 min) measurements. The precise measures and timepoints for the measures are further defined below. There will be a one-week minimum washout period between treatments in the crossover design. **Detailed Description:** Pre-screening/enrollment (Day -30 to Day -1) The potential subject will present a health history / Caffeine Consumption / Morningness-Eveningness questionnaires to screen for study eligibility described in sections 5.2.1 (inclusion criteria) and 5.2.2 (exclusion criteria). The questionnaires will be reviewed by the Investigator or designee. If the subject is eligible, they will be contacted by phone to walk through the study requirements and answer any questions. If the subject qualifies and is amenable with the study requirements, we will obtain written consent via an IRB approved ICF. The potential subject will be given the opportunity to review the ICF, ask any questions they may have to the Investigator or designee. The potential subject will be required to sign the ICF for study enrollment and to proceed with study participation. Baseline assessment (Day 0, Visit 1) After initial pre-screening, participants will report to the laboratory on two separate occasions after an overnight fast (10 hours minimum). Participants will be required to have a night of partial sleep deprivation the night before (≤ 5 hours sleep), which will be confirmed by self reported sleep logs and objective multisensor (triaxial accelerometry and cardiac data) wearable devices to accurately measure sleep deficit data (Roberts et al., 2020). Upon arrival, participants will undergo baseline (BL) testing (Heart rate, blood pressure, Caffeine VAS, Samn-Perilli/Thayer's, PANAS, PVT, RVIP). Immediately after, subjects will ingest a bolus of one study product (either ER-CAFF or IR-CAFF) with 4-8 ounces of water: 400 mg zümXR extended-release caffeine (ER-CAFF), or 400 mg of immediate-release caffeine (IR-CAFF) (2 group, crossover design). Thereafter, participants will undergo subsequent testing sessions at 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation. This testing will include the vitals listed above, a subset of the BL tests according to the time point (see below, Table 2), and queried about adverse events. At the 4-hour (240 min) measurement, a standardized caffeine-free food bar will be provided. This food bar will also be offered to participants following the final 7-hour (420 min) measurements. After the completion of Day 0, There will be a one-week minimum washout period between treatments in the crossover design. Final Testing (Day 1, Visit 2): After the one-week minimum washout period, subjects will report back to the lab and will repeat Day 0 testing with the other supplement (either ER-CAFF or IR-CAFF). Following this testing, the subjects will have completed the study. ### Conditions Module **Conditions:** - Caffeine - Cognitive Change - Mood - Mood Change **Keywords:** - extended release caffeine - caffeine ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** extended release xumXR caffeine (200mg) capsule; subject receives 2 capsules totaling 400mg **Intervention Names:** - Dietary Supplement: xumXR extended release caffeine **Label:** Experimental Treatment **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** immediate release caffeine (200mg) capsule; subject receives 2 capsules totaling 400mg **Intervention Names:** - Dietary Supplement: immediate release caffeine **Label:** Control Treatment **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental Treatment **Description:** proprietary capsule for extended release of caffeine **Name:** xumXR extended release caffeine **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Control Treatment **Description:** immediate release caffeine capsule **Name:** immediate release caffeine **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Other Outcomes **Description:** Will be recorded based on observation and verbal subject questioning. Defined as participants self-reported adverse effects. Items that will be surveyed are headache, dizziness, nausea, vomiting, indigestion, blurred vision, lethargy, swelling, itching, chest pain, heart palpitations, difficulty breathing, lethargy, and muscle cramps. **Measure:** Adverse Events **Time Frame:** baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation. #### Primary Outcomes **Description:** The test consists of a horizontal line, with endpoints labeled as "no effect" or "extremely high effect" to represent the continuum of caffeine effects experienced by the subject. Users mark on the line to indicate their perception regarding caffeine effects. **Measure:** Changes in Alertness using Visual Analog Scale (VAS) **Time Frame:** baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation. **Description:** The test consists of a horizontal line, with endpoints labeled as "no effect" or "extremely high effect" to represent the continuum of caffeine effects experienced by the subject. Users mark on the line to indicate their perception regarding caffeine effects. **Measure:** Changes in Energy using Visual Analog Scale (VAS) **Time Frame:** baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation. **Description:** The test consists of a horizontal line, with endpoints labeled as "no effect" or "extremely high effect" to represent the continuum of caffeine effects experienced by the subject. Users mark on the line to indicate their perception regarding caffeine effects. **Measure:** Changes in Mood Enhancement using Visual Analog Scale (VAS) **Time Frame:** baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation. **Description:** The test consists of a horizontal line, with endpoints labeled as "no effect" or "extremely high effect" to represent the continuum of caffeine effects experienced by the subject. Users mark on the line to indicate their perception regarding caffeine effects. **Measure:** Changes in Jitteriness using Visual Analog Scale (VAS) **Time Frame:** baseline, 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation. **Description:** Changes in heart rate post supplementation; resting HR measured using pulse oximeter **Measure:** Heart rate (HR) **Time Frame:** baseline, 45, 60, 135, 240, 360, and 420 minutes post-supplementation **Description:** Changes in BP post supplementation. Resting blood pressure measured using an automated BP cuff. **Measure:** Blood Pressure (BP) **Time Frame:** baseline, 45, 60, 135, 240, 360, and 420 minutes post-supplementation #### Secondary Outcomes **Description:** This 12 minute test checks how well you can quickly spot specific patterns on a screen, helping measure your attention and focus. A participant is presented with a series of digits (1-9) on a computer screen. The presentation time is 100 digits/min (or 1digit/600ms). The participant's task is to press a response key (here: Spacebar) as soon as she detects a series of three consecutive odd or three consecutive even digits. **Measure:** Changes in Rapid Visual Information Processing **Time Frame:** baseline , 90 and 300 minutes post-supplementation. **Description:** This test measures how quickly and accurately you can respond to simple tasks, like pressing a button when you see a specific symbol. It assesses your reaction time and attention span. Participants are instructed to press the \<Spacebar\> as fast as possible after a red stopwatch appears on screen. A valid response (response occurs after a stopwatch appears) is followed by reaction time feedback. **Measure:** Changes in Psychomotor Vigilance Test **Time Frame:** baseline , 90 and 300 minutes post-supplementation. **Description:** This subjective assessment tool will be used to measure the subject's perceived level of sleepiness or alertness. This tool consists of seven statements or descriptions, each corresponding to a different level of sleepiness or alertness. Respondents are asked to select the statement that best describes their current level of alertness. The scale ranges from 1 to 7, with 1 indicating the highest level of alertness (feeling active, vital, alert, or wide awake) and 7 indicating the lowest level of alertness (no longer fighting sleep, sleep onset soon, having dream-like thoughts). **Measure:** Changes in Samn-Perelli/Thayer's scale (aka Stanford Sleepiness Scale) **Time Frame:** baseline, 90, 300, and 420 minutes post-supplementation. **Description:** This scale consists of a number of words that describe different feelings and emotions. Subject will choose a number 1 through 5 (1=Very slightly or not at all, 5=extremely) to describe the feeling/emotion listed. Overall positive and negative scores will be tallied for interpretation. **Measure:** Changes in Positive & Negative Affect Schedule (PANAS) **Time Frame:** baseline, 90, 300, and 420 minutes post-supplementation. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or female aged 35-50 years (both limits inclusive); * Body mass index (BMI) of 18.50-29.99 kg/m2 -Habitual moderate caffeine consumers (200-400 mg/day) assessed through caffeine assessment tool (Caffeine - * Consumption Questionnaire, CCQ); * Intermediate chronotype (\>31 or \<69 on Morningness-Eveningness Questionnaire). Exclusion Criteria: * Subjects presenting any of the following will not be included in the study: * No history of anxiety disorders or sleep disorders; * Non-smokers; * Alcohol consumption 72 hours prior to the start of study/consumption of study product; * No use of sleep medicines, melatonin, marijuana within two weeks of start of study; * No travel involving time zone change, shift work, or other life events that alter sleep schedule \>3 hours from the norm one week before the start of study (assessed using sleep-wake schedule diary for week prior to study); * Caffeine restricted past 12 PM from the day prior to the start of study (verify through caffeine diet history). **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 35 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Eric Sikorski, PhD **Phone:** 8138678888 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Matthew Sharp, MS **Phone:** 8138678888 **Role:** CONTACT #### Locations **Location 1:** **City:** Tampa **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Eric Sikorski, PhD - **Phone:** 813-867-8888 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Matthew Sharp, MS - **Phone:** 8138678888 - **Role:** CONTACT ***Contact 3:*** - **Name:** Eric Sikorski, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Jacob Wilson, PhD - **Role:** SUB_INVESTIGATOR **Country:** United States **Facility:** Applied Science & Performance Institute **State:** Florida **Status:** RECRUITING **Zip:** 33634 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: Rare - Name: Rare Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: T170 - Name: Acute Graft Versus Host Disease - 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: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CNSSti - Name: Central Nervous System Stimulants - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - 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:** NCT06441682 **Acronym:** ReALiSe **Brief Title:** A Safety and Efficacy Study of ARGX-119 in Adult Patients With Amyotrophic Lateral Sclerosis (ALS) **Official Title:** A Phase 2a, Double-Blinded, Randomized, Placebo-Controlled, and Active-Treatment Extension Study to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of ARGX-119 in Participants With Amyotrophic Lateral Sclerosis #### Organization Study ID Info **ID:** ARGX-119-2303 #### Organization **Class:** INDUSTRY **Full Name:** argenx #### Secondary ID Infos **ID:** 2024-511318-19-00 **Type:** CTIS ### Status Module #### Completion Date **Date:** 2027-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-02 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** argenx #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study aims to evaluate the safety of ARGX-119 in adults with ALS. The study will also assess the impact of ARGX-119 on ALS disease outcomes, including muscle function. The study consists of 2 periods: a treatment period when participants will receive one of three ARGX-119 doses or placebo and an extension period when all participants will receive the same dose of ARGX-119. Participation in the study will last up to approximately 100 weeks. ### Conditions Module **Conditions:** - Amyotrophic Lateral Sclerosis ### 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:** 60 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive first dosage level of ARGX-119 intravenously during the double blinded treatment period followed by ARGX-119 in active treatment extension period **Intervention Names:** - Biological: ARGX-119 **Label:** ARGX-119 - Dose 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive second dosage level of ARGX-119 intravenously during the double blinded treatment period followed by ARGX-119 in active treatment extension period **Intervention Names:** - Biological: ARGX-119 **Label:** ARGX-119 - Dose 2 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Participants will receive third dosage level of ARGX-119 intravenously during the double blinded treatment period followed by ARGX-119 in active treatment extension period **Intervention Names:** - Biological: ARGX-119 **Label:** ARGX-119 - Dose 3 **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Participants will receive placebo intravenously during the double-blinded treatment period followed by ARGX-119 in active treatment extension period **Intervention Names:** - Biological: ARGX-119 - Other: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - ARGX-119 - Dose 1 - ARGX-119 - Dose 2 - ARGX-119 - Dose 3 - Placebo **Description:** Intravenous infusion of ARGX-119 **Name:** ARGX-119 **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Intravenous infusion of placebo **Name:** Placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Assessment of adverse events (AEs) **Time Frame:** Up to week 96 #### Secondary Outcomes **Measure:** Rate of change from baseline in electrophysiological muscle scan (MScan)-derived motor unit number (MUN) **Time Frame:** Up to week 24 **Measure:** Maximum observed serum concentration (Cmax) of ARGX-119 **Time Frame:** Up to week 96 **Measure:** Incidence of anti-drug antibodies (ADA) against ARGX-119 in serum over time **Time Frame:** Up to week 96 **Measure:** Prevalence of anti-drug antibodies (ADA) against ARGX-119 in serum over time **Time Frame:** Up to week 96 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * The participant is at least 18 and ≤80 years of age * The participant is diagnosed with familial or sporadic ALS according to Gold Coast criteria * The participant has a Treatment Research Initiative to Cure ALS (TRICALS) risk profile of ≥ -6.0 to \< -2.0 * Slow vital capacity (SVC) of ≥ 60% of the predicted value according to Global Lung Function Initiative 2012 Exclusion Criteria: * Use of noninvasive ventilation more than 10 hours a day or use of a tracheostomy for ventilatory support * Any history of or current exposure to any gene or cell therapies (off-label use or investigational) for ALS * Pregnant or lactating state or intention to become pregnant during the study **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:** Sabine Coppieters, MD **Phone:** 857-350-4834 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000013118 - Term: Spinal Cord Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000057177 - Term: TDP-43 Proteinopathies - ID: D000057165 - Term: Proteostasis Deficiencies - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15415 - Name: Sclerosis - Relevance: HIGH - As Found: Sclerosis - ID: M18879 - Name: Motor Neuron Disease - Relevance: HIGH - As Found: Lateral Sclerosis - ID: M4024 - Name: Amyotrophic Lateral Sclerosis - Relevance: HIGH - As Found: Amyotrophic Lateral Sclerosis - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M15915 - Name: Spinal Cord Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M28759 - Name: TDP-43 Proteinopathies - Relevance: LOW - As Found: Unknown - ID: M28747 - Name: Proteostasis Deficiencies - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: T4699 - Name: Primary Lateral Sclerosis - Relevance: HIGH - As Found: Lateral Sclerosis - ID: T349 - Name: Amyotrophic Lateral Sclerosis - Relevance: HIGH - As Found: Amyotrophic Lateral Sclerosis ### Condition Browse Module - Meshes - ID: D000016472 - Term: Motor Neuron Disease - ID: D000000690 - Term: Amyotrophic Lateral Sclerosis - ID: D000012598 - Term: Sclerosis ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441669 **Brief Title:** Effect of Letermovir Prophylaxis on CMV-specific Immune Reconstitution Post UCBT **Official Title:** Effect of Letermovir Prophylaxis on Cytomegalovirus-specific Immune Reconstitution Post Unrelated Cord Blood Transplantation #### Organization Study ID Info **ID:** CBCMV001 #### Organization **Class:** OTHER_GOV **Full Name:** Anhui Provincial Hospital ### Status Module #### Completion Date **Date:** 2026-05-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-05-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Anhui Provincial 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:** To explore the effect of letermovir prophylaxis on cytomegalovirus-specific immune reconstitution post unrelated cord blood transplantation **Detailed Description:** To explore the effect of letermovir prophylaxis on cytomegalovirus-specific and other lymphocyte subsets immune reconstitution post unrelated cord blood transplantation, and to analyze the potential mechanism and risk factors of late CMV reactivation after letermovir discontinuation. ### Conditions Module **Conditions:** - Cytomegalovirus Infection Reactivation **Keywords:** - Cytomegalovirus Infection - Umbilical Cord Blood Transplantation - CMV-Specific Immune Reconstitution - Letermovir ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will be given Letermovir with a recommended dose of 480 mg per day (or 240 mg per day in patients taking cyclosporine or according to clinical instructions) from +1 day to +100 days after UCBT. **Intervention Names:** - Drug: Letermovir **Label:** letermovir group ### Interventions #### Intervention 1 **Arm Group Labels:** - letermovir group **Description:** Patients will be given Letermovir with a recommended dose from +1 day to +100 days after UCBT. **Name:** Letermovir **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** PBMCs from UCBT recipients were collected at 1 month, 2 month, 3 month, and 6 month and 12 month after HSCT, and tested for CMV-specific T cells, NK cells, T cells and other subsets. **Measure:** Numbers of immune cells in peripheral blood **Time Frame:** one year **Description:** CMV DNAemia is defined as the detection of CMV DNA in samples of plasma, whole blood or isolated peripheral blood leukocyte. **Measure:** CMV DNAemia **Time Frame:** one year **Description:** Refractory CMV infection is defined as CMV viral load remaining at the same level or increasing despite appropriately doses of antiviral therapy for at least 2 weeks **Measure:** Incidence of refractory CMV infection **Time Frame:** one year **Description:** Late CMV reactivation is defined as reactivation that occurs 100 days post UCBT, which means reactivation after discontinuing LET prophylaxis. **Measure:** late CMV reactivation **Time Frame:** one year #### Secondary Outcomes **Description:** Treatment-ralated mortality **Measure:** Treatment-ralated mortality **Time Frame:** one year **Description:** Other viral infection and viral-associated diseases including EBV, ADV, HHV-6, BKV and HSV **Measure:** Incidence of other viral infection and viral-associated disease **Time Frame:** one year **Description:** Overall survival **Measure:** Overall survival **Time Frame:** one year **Description:** The serum levels of IgG, IgM, and IgA were measured **Measure:** serum immunoglobulin assay **Time Frame:** 1,3,6,9 month post UCBT ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients are receiving a first unrelated cord blood transplantation (UCBT). * Patients start letemovir prophylaxis within 0-28 days post UCBT. Exclusion Criteria: * Patients having active CMV DNAemia at the time of letermovir initiation. * Patients recruited in a clinical study on an anti-CMV trial. **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** The study consists 60 cases recipients of UCBT. All patients will receive letermovir prophylaxis within 0-28 days post UCBT. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Xiaoyu Zhu, ph.D **Phone:** 15255456091 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Bingbing Yan **Phone:** 15993691727 **Role:** CONTACT #### Locations **Location 1:** **City:** Hefei **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Xiaoyu Zhu, ph.D - **Phone:** 15255456091 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Bingbing Yan - **Phone:** 15993691727 - **Role:** CONTACT **Country:** China **Facility:** Anhui Provincial Hospital **State:** Anhui **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** The First Affiliated Hospital of University of Science and Technology of China (Anhui Provicial Hospital) **Name:** Xiaoyu Zhu, ph.D **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007239 - Term: Infections - ID: D000006566 - Term: Herpesviridae Infections - ID: D000004266 - Term: DNA Virus Infections - ID: D000014777 - Term: Virus Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M6791 - Name: Cytomegalovirus Infections - Relevance: HIGH - As Found: Cytomegalovirus Infections - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M2512 - Name: Latent Infection - Relevance: HIGH - As Found: Infection Reactivation - ID: M9643 - Name: Herpesviridae 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: T1720 - Name: Cytomegalic Inclusion Disease - Relevance: HIGH - As Found: Cytomegalovirus Infections ### Condition Browse Module - Meshes - ID: D000003586 - Term: Cytomegalovirus Infections - ID: D000085343 - Term: Latent Infection ### Intervention Browse Module - Ancestors - ID: D000067856 - Term: Poly(ADP-ribose) Polymerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents - ID: D000000998 - Term: Antiviral Agents - ID: D000000890 - Term: Anti-Infective Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Derm - Name: Dermatologic Agents ### Intervention Browse Module - Browse Leaves - ID: M233992 - Name: Letermovir - Relevance: HIGH - As Found: Responsibility - ID: M18961 - Name: Cyclosporine - Relevance: LOW - As Found: Unknown - ID: M6730 - Name: Cyclosporins - Relevance: LOW - As Found: Unknown - ID: M205 - Name: Poly(ADP-ribose) Polymerase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4314 - Name: Antiviral Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000588473 - Term: Letermovir ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441656 **Acronym:** Flip and Fix **Brief Title:** The (Flip and Fix) Internal Limiting Flap Technique Versus the Classic Temporal Flap for Macular Hole Repair **Official Title:** The (Flip and Fix) Internal Limiting Flap Technique Versus the Classic Temporal Flap for Macular Hole Repair #### Organization Study ID Info **ID:** Flip and Fix ILM flap #### Organization **Class:** OTHER **Full Name:** Alexandria University ### Status Module #### Completion Date **Date:** 2023-02-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-02-01 **Type:** ACTUAL #### Start Date **Date:** 2021-02-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Alexandria University #### Responsible Party **Investigator Affiliation:** Alexandria University **Investigator Full Name:** Islam Shereen Hamdy **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Purpose To describe a novel technique of MH repair and compare it to the perfluorocarbon liquid (PFCL) assisted temporal ILM flap technique. Methods Twenty-two eyes of 22 patients with MH were randomized on 1:1 basis into two groups. Group A cases were treated using the (Flip and Fix) technique in which the single-layer ILM flap was (flipped), flattened over the macula using PFCL and (fixed) in place using 2 drops of autologous non-heparinized blood over the superonasal and the inferonasal edges of the flap (away from the MH center). Group B patients had the classic temporal ILM flap technique without using the PFCL or autologous blood. All patients were followed up for a period of 6 months after the surgery. Results No significant difference was observed in initial and final visual acuities between Groups A and B. Intraoperative flap displacement and did not occur in Group A and occurred in 2 eyes in Group B (18.2%) one of them showed failed MH closure and required reoperation, These 2 cases had a final (W shape) MH closure and a worse final vision than the remaining cases which had either (U shape) or (V shape) final MH closure. Conclusions The study results show that the (Flip and Fix) technique is as effective as the PFCL-assisted temporal ILM flap technique and is associated with less ILM flap displacement risk for the repair of macular holes. **Detailed Description:** We conducted a prospective randomized comparative interventional study in which we enrolled patients older than 50 years with idiopathic macular holes who presented to (Removed in the blinded version of manuscript) in the period between February 2021 and February 2022. Patients with previous macular surgeries and those with any other significant macular pathologies e.g., diabetic macular oedema, myopic maculopathy, choroidal neovascular membrane, or macula-off retinal detachment were excluded. The study protocol was reviewed and approved by the Ethics Committee of (Removed in the blinded version of manuscript). All patients signed an informed consent after explaining the procedures. The study was conducted in accordance with the tenets of the Declaration of Helsinki. For all the patients, a retina consultant (I. A.) masked to the procedure that will be done for the patient conducted a comprehensive ophthalmic examination, including best-corrected visual acuity (BCVA) (measured using the Snellen's chart and then converted to the LogMAR for the statistical analysis), slit-lamp examination, and fundus examination. All the patients had a pre-operative macular OCT scan done. The scans were assessed by the masked retina consultant (I. A.) to confirm the diagnosis and to measure the minimum MH diameter. The included patients were randomized by a research nurse on a 1:1 basis using the closed envelope technique to have either the new (Flip and fix) technique (Group A) or the PFCL assisted temporal inverted ILM flap technique (Group B). All the surgeries were done under general anaesthesia by a single surgeon (M. A.) using a wide-angle viewing non-contact system (Resight; Carl Zeiss Meditec AG, Jena, Germany) and 23 Gauge Alcon Constellation vitrectomy machine (Alcon Laboratories, Fort Worth, TX) to complete the core vitrectomy and induction of the posterior vitreous detachment if not already detached, this was followed by an injection the Brilliant Blue G (Tissueblue 0.025% DORC, Zuidland, The Netherland) to stain the ILM. In both groups, a single-layer ILM temporal flap of approximately 2 times the size of the optic disc was fashioned using an ILM forceps temporal to the macula. The nasal edge of the flap was not detached from the temporal MH edge. The flap was reflected nasally to cover the MH In the (Flip and Fix) technique group, the (flipped) ILM flap was secured in place and flattened over the macular surface using a 1.5 cc bubble of PFCL (Arcaline; Arcadophtha, Toulouse, France) injected over the flipped ILM flap. Then fluid air exchange with removal of the PFCL bubble was done followed by (fixing) the ILM flap over the macular surface using two drops of autologous non-heparinized blood -collected by the attending nurse or anaesthesiologist from one of the veins on the dorsum of the hand- one dropped over the superior-nasal and another at the inferior-nasal edges of the ILM flap (away from the MH center). On the other hand, in the classic temporal ILM flap group, PFCL and blood were not used to fix the ILM flap. Videos demonstrating the technique are provided as supplemental files 1 and 2. In both groups, at the conclusion of the surgery the air was exchanged for a non-expansile concentration (20%) of sulphur hexafluoride gas SF6 and the patient was asked to maintain a face -down position for 5 days postoperatively. The surgical steps of the (flap and fix) technique are summarized in Figure 1. For all the cases, intraoperative ILM flap displacement (defined as a significant displacement of the inverted ILM flap after its initial positioning over the MH that necessitated readjustment) was reported by the operating surgeon. All the patients were examined postoperatively at 1, 3, and 6 months by a retina consultant masked to the used surgical procedure (I. A). The best corrected visual acuity, slit-lamp examination, fundus examination and macular OCT scanning were done in each postoperative visit. According to the cross-sectional morphology on the postoperative macular OCT scan, foveal contour was classified into one of the following categories: U-shape, V-shape, and W-shape (irregular). The presence of a thin hyperreflective band of tissue extending on both sides of the previous MH Flap between the inner surface of the retina was assessed and considered a (membranous i.e., flap closure). The data about the pre-operative MH base size, minimum MH diameter, BCVA, post-operative closure rate, BCVA, and the pattern of the MH closure was collected. ### Conditions Module **Conditions:** - Hacular Hole Repair **Keywords:** - Macular hole, Internal limiting membrane, pars plana vitrectomy, perfluorocarbon liquid, non-heparinized blood ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Prospective comparative ##### Masking Info **Masking:** TRIPLE **Masking Description:** The investigator assessing the outcome was masked to the type of surgery done **Who Masked:** - PARTICIPANT - CARE_PROVIDER - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 22 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In the (Flip and Fix) technique group, the (flipped) ILM flap was secured in place and flattened over the macular surface using a 1.5 cc bubble of PFCL (Arcaline; Arcadophtha, Toulouse, France) injected over the flipped ILM flap. Then fluid air exchange with removal of the PFCL bubble was done followed by (fixing) the ILM flap over the macular surface using two drops of autologous non-heparinized blood -collected by the attending nurse or anaesthesiologist from one of the veins on the dorsum of the hand- one dropped over the superior-nasal and another at the inferior-nasal edges of the ILM flap (away from the MH center). **Intervention Names:** - Procedure: Vitrectomy with ILM flap **Label:** Flip and fix ILM flap **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** PFCL and blood were not used to fix the ILM flap **Intervention Names:** - Procedure: Vitrectomy with ILM flap **Label:** classic temporal ILM flap **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Flip and fix ILM flap - classic temporal ILM flap **Description:** In both groups, a single-layer ILM temporal flap of approximately 2 times the size of the optic disc was fashioned using an ILM forceps temporal to the macula. The nasal edge of the flap was not detached from the temporal MH edge. The flap was reflected nasally to cover the MH **Name:** Vitrectomy with ILM flap **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Macular OCT scan was used to assess the MH closure **Measure:** Macular hoe closure by OCT scan **Time Frame:** 1, 3, and six months postoperatively **Description:** Best corrected visual acuity was assessed using the LogMAR vision **Measure:** LogMAR visual acuity **Time Frame:** 1, 3, and six months postoperatively ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: patients with idiopathic macular holes who presented to (Removed in the blinded version of manuscript) in the period between February 2021 and February 2022. Exclusion Criteria: Patients with previous macular surgeries and those with any other significant macular pathologies e.g., diabetic macular oedema, myopic maculopathy, choroidal neovascular membrane, or macula-off retinal detachment - - **Maximum Age:** 100 Years **Minimum Age:** 50 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Alexandria **Country:** Egypt **Facility:** Faculty of Medicine Alexandria University #### Overall Officials **Official 1:** **Affiliation:** University of Alexandria **Name:** Islam SH Ahmed, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** The data are available upon request **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012164 - Term: Retinal Diseases - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M15002 - Name: Retinal Perforations - Relevance: HIGH - As Found: Macular Hole - ID: M14999 - Name: Retinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012167 - Term: Retinal Perforations ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441643 **Brief Title:** Next Generation Rocklatan **Official Title:** A Phase II, Prospective, Two-Stage, Double-Masked, Randomized, Multi-Center, Controlled, Dose-Response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-17043 and PG043 (AR-17043/Latanoprost) Ophthalmic Solutions in Subjects With Elevated Intraocular Pressure #### Organization Study ID Info **ID:** GLR305-E001 #### Organization **Class:** INDUSTRY **Full Name:** Alcon Research ### Status Module #### Completion Date **Date:** 2025-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-09 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Alcon Research #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this two-stage clinical trial is to assess the safety and hypotensive efficacy of AR-17043 and PG043 ophthalmic solutions in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT). **Detailed Description:** During Stage 1, approximately 100 adult subjects with OAG or OHT will be randomized to 5 arms: 3 different concentrations of AR-17043, placebo comparator, or netarsudil 0.02% (Rhopressa®) for a treatment duration of 7 days. During Stage 2, approximately 350 adult subjects with OAG or OHT will be randomized to 5 arms: low and high concentrations of PG043 (AR-17043/latanoprost 0.005%), AR-17043 high concentration, latanoprost, or netarsudil 0.02%/latanoprost 0.005% (Rocklatan®) for a treatment duration of 28 days. ### Conditions Module **Conditions:** - Open Angle Glaucoma - Ocular Hypertension **Keywords:** - Glaucoma - IOP ### 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:** 450 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7. **Intervention Names:** - Drug: AR-17043 Ophthalmic Solution **Label:** AR-17043 low concentration (Stage 1) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7. **Intervention Names:** - Drug: AR-17043 Ophthalmic Solution **Label:** AR-17043 medium concentration (Stage 1) **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7. **Intervention Names:** - Drug: AR-17043 Ophthalmic Solution **Label:** AR-17043 high concentration (Stage 1) **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** AR-17043 Vehicle, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7. **Intervention Names:** - Drug: AR-17043 Vehicle **Label:** AR-17043 vehicle (Stage 1) **Type:** PLACEBO_COMPARATOR #### Arm Group 5 **Description:** Netarsudil 0.02% Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7. **Intervention Names:** - Drug: Netarsudil 0.02% Ophthalmic Solution **Label:** Rhopressa (Stage 1) **Type:** ACTIVE_COMPARATOR #### Arm Group 6 **Description:** PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28. **Intervention Names:** - Drug: PG043 Ophthalmic Solution **Label:** PG043 low concentration (Stage 2) **Type:** EXPERIMENTAL #### Arm Group 7 **Description:** PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28. **Intervention Names:** - Drug: PG043 Ophthalmic Solution **Label:** PG043 high concentration (Stage 2) **Type:** EXPERIMENTAL #### Arm Group 8 **Description:** AR-17043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28. **Intervention Names:** - Drug: AR-17043 Ophthalmic Solution **Label:** AR-17043 high concentration (Stage 2) **Type:** ACTIVE_COMPARATOR #### Arm Group 9 **Description:** Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28. **Intervention Names:** - Drug: Latanoprost 0.005% Ophthalmic Solution **Label:** Latanoprost (Stage 2) **Type:** ACTIVE_COMPARATOR #### Arm Group 10 **Description:** Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28. **Intervention Names:** - Drug: Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution **Label:** Rocklatan (Stage 2) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - AR-17043 high concentration (Stage 1) - AR-17043 high concentration (Stage 2) - AR-17043 low concentration (Stage 1) - AR-17043 medium concentration (Stage 1) **Description:** Investigational monotherapy supplied in three concentration levels: low, medium, high **Name:** AR-17043 Ophthalmic Solution **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - PG043 high concentration (Stage 2) - PG043 low concentration (Stage 2) **Description:** Investigational fixed dose combination supplied in two concentration levels: low and high **Name:** PG043 Ophthalmic Solution **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Latanoprost (Stage 2) **Description:** Marketed monotherapy **Name:** Latanoprost 0.005% Ophthalmic Solution **Other Names:** - Latanoprost **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Rhopressa (Stage 1) **Description:** Marketed monotherapy **Name:** Netarsudil 0.02% Ophthalmic Solution **Other Names:** - Rhopressa® **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - Rocklatan (Stage 2) **Description:** Marketed fixed dose combination **Name:** Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution **Other Names:** - Rocklatan® **Type:** DRUG #### Intervention 6 **Arm Group Labels:** - AR-17043 vehicle (Stage 1) **Description:** Placebo comparator **Name:** AR-17043 Vehicle **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Intraocular pressure (IOP) will be measured with a Goldmann tonometer. Diurnal IOP will be calculated as the average of the four measurements. **Measure:** Mean diurnal IOP at Day 8 (Stage 1) **Time Frame:** Day 8 (8:00, 10:00, 12:00, 16:00) **Description:** Intraocular pressure (IOP) will be measured with a Goldmann tonometer. Diurnal IOP will be calculated as the average of the three measurements. **Measure:** Mean diurnal IOP at Day 29 (Stage 2) **Time Frame:** Day 29 (8:00, 10:00, 16:00) #### Secondary Outcomes **Description:** Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint. **Measure:** Mean IOP at each post-treatment timepoint (Stage 1) **Time Frame:** Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00) **Description:** Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment. **Measure:** Mean change from the diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1) **Time Frame:** Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00) **Description:** Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment. **Measure:** Mean percent change from diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1) **Time Frame:** Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00) **Description:** Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the four baseline measurements. Baseline is defined as the last visit prior to initiation of treatment. **Measure:** Mean change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 1) **Time Frame:** Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00) **Description:** Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the four baseline measurements. Baseline is defined as the last visit prior to initiation of treatment. **Measure:** Mean percent change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 1) **Time Frame:** Baseline (8:00, 10:00, 12:00, 16:00); Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00) **Description:** Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint. **Measure:** Mean IOP at each post-treatment timepoint (Stage 2) **Time Frame:** Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00) **Description:** Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment. **Measure:** Mean change from the diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 2) **Time Frame:** Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00) **Description:** Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment. **Measure:** Mean percent change from diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 2) **Time Frame:** Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00) **Description:** Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the three baseline measurements. Baseline is defined as the last visit prior to initiation of treatment. **Measure:** Mean change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 2) **Time Frame:** Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00) **Description:** Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the three baseline measurements. Baseline is defined as the last visit prior to initiation of treatment. **Measure:** Mean percent change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 2) **Time Frame:** Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00) ### Eligibility Module **Eligibility Criteria:** Stage 1 Key Inclusion Criteria; * Diagnosis of OAG or OHT in both eyes. * High unmedicated IOP measurements in the study eye as specified in the protocol. * Corrected visual acuity equal to or better than +1.0 logMAR (Snellen equivalent equal to or better than 20/200) in the study eye. * Other protocol-specified inclusion criteria may apply. Stage 2 Key Inclusion Criteria: * Diagnosis of OAG or OHT in both eyes. * High unmedicated IOP measurements in the study eye as specified in the protocol. * Corrected visual acuity equal to or better than +0.7 logMAR (Snellen equivalent equal to or better than 20/100) in the study eye. * Other protocol-specified inclusion criteria may apply. Stage 1 and Stage 2 Key Exclusion Criteria: * Current use of more than 2 ocular hypotensive medications within 30 days (either eye). * Intraocular pressure greater than 36 millimeters mercury (mmHg) at Screening. * Glaucoma other than OAG. * Previous glaucoma surgery. * Any abnormality preventing reliable measurements. * Unable to demonstrate proper eyedrop instillation. * Other protocol-specified exclusion criteria may apply. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Alcon Call Center **Phone:** 1-888-451-3937 **Role:** CONTACT #### Locations **Location 1:** **City:** Inglewood **Country:** United States **Facility:** United Medical Research Institute **State:** California **Zip:** 90301 **Location 2:** **City:** Newport Beach **Country:** United States **Facility:** Eye Research Foundation **State:** California **Zip:** 92663 **Location 3:** **City:** Fort Collins **Country:** United States **Facility:** Eye Center of Northern Colorado, PC **State:** Colorado **Zip:** 80528 **Location 4:** **City:** Roswell **Country:** United States **Facility:** Coastal Research Associates **State:** Georgia **Zip:** 30076 **Location 5:** **City:** Cranberry Township **Country:** United States **Facility:** Scott & Christie and Associates, PC **State:** Pennsylvania **Zip:** 16066 **Location 6:** **City:** Maryville **Country:** United States **Facility:** University Eye Specialists **State:** Tennessee **Zip:** 37803 **Location 7:** **City:** Lynchburg **Country:** United States **Facility:** Piedmont Eye Center **State:** Virginia **Zip:** 24502 #### Overall Officials **Official 1:** **Affiliation:** Alcon Research, LLC **Name:** Clinical Trial Lead, Pharma **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC11 - Name: Eye Diseases ### Condition Browse Module - Browse Leaves - ID: M10024 - Name: Hypertension - Relevance: LOW - As Found: Unknown - ID: M9013 - Name: Glaucoma - Relevance: HIGH - As Found: Glaucoma - ID: M9014 - Name: Glaucoma, Open-Angle - Relevance: HIGH - As Found: Open Angle Glaucoma - ID: M12731 - Name: Ocular Hypertension - Relevance: HIGH - As Found: Ocular Hypertension - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005901 - Term: Glaucoma - ID: D000005902 - Term: Glaucoma, Open-Angle - ID: D000009798 - Term: Ocular Hypertension ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AnAg - Name: Antihypertensive Agents ### Intervention Browse Module - Browse Leaves - ID: M12814 - Name: Ophthalmic Solutions - Relevance: HIGH - As Found: 14 days - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: HIGH - As Found: Procedure - ID: M1775 - Name: Latanoprost - Relevance: HIGH - As Found: Color - ID: M4277 - Name: Antihypertensive Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000019999 - Term: Pharmaceutical Solutions - ID: D000077338 - Term: Latanoprost - ID: D000009883 - Term: Ophthalmic Solutions ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441630 **Brief Title:** A Study to Evaluate the Efficacy and Safety of Co-administration of AD-227A and AD-227B **Official Title:** A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of AD-227A and AD-227B Combination Treatment in Patients With Essential Hypertension #### Organization Study ID Info **ID:** AD-227P3 #### Organization **Class:** INDUSTRY **Full Name:** Addpharma Inc. ### Status Module #### Completion Date **Date:** 2025-01-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-05 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-03 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-01-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-17 **Type:** ESTIMATED **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Addpharma Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The purpose of this study is to evaluate the efficacy and safety of co-administration of AD-227A and AD-227B in patients with essential hypertension **Detailed Description:** Essential Hypertension ### Conditions Module **Conditions:** - Essential Hypertension ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 251 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** AD-227A + AD-227B + Placebo of AD-227C **Intervention Names:** - Drug: AD-227A - Drug: AD-227B - Drug: Placebo of AD-227C **Label:** Co-administration of AD-227A and AD-227B **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** AD-227A + Placebo of AD-227B + Placebo of AD-227C **Intervention Names:** - Drug: AD-227A - Drug: Placebo of AD-227B - Drug: Placebo of AD-227C **Label:** AD-227A **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** AD-227A + Placebo of AD-227B + AD-227C **Intervention Names:** - Drug: AD-227A - Drug: AD-227C - Drug: Placebo of AD-227B **Label:** Co-administration of AD-227A and AD-227C **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - AD-227A - Co-administration of AD-227A and AD-227B - Co-administration of AD-227A and AD-227C **Description:** Per Oral, 1 Tablet, Once a day for 8 weeks **Name:** AD-227A **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Co-administration of AD-227A and AD-227B **Description:** Per Oral, 1 Tablet, Once a day for 8 weeks **Name:** AD-227B **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Co-administration of AD-227A and AD-227C **Description:** Per Oral, 1 Tablet, Once a day for 8 weeks **Name:** AD-227C **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - AD-227A - Co-administration of AD-227A and AD-227C **Description:** Per Oral, 1 Tablet, Once a day for 8 weeks **Name:** Placebo of AD-227B **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - AD-227A - Co-administration of AD-227A and AD-227B **Description:** Per Oral, 1 Tablet, Once a day for 8 weeks **Name:** Placebo of AD-227C **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Change from Baseline in Mean Sitting Systolic Blood Pressure **Measure:** Change in MSSBP **Time Frame:** Baseline to Week8 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Signed informed consent * Patients with Essential Hypertension * Other inclusions applied Exclusion Criteria: * Patient with Secondary Hypertension * Other exclusions applied **Minimum Age:** 19 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** JeongEun Park **Phone:** +82-31-891-6989 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Gangnam CHA Medical Center **Name:** Chong-Jin Kim **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10024 - Name: Hypertension - Relevance: HIGH - As Found: Hypertension - ID: M1470 - Name: Essential Hypertension - Relevance: HIGH - As Found: Essential Hypertension - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006973 - Term: Hypertension - ID: D000075222 - Term: Essential Hypertension ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441617 **Acronym:** CAFE-MS **Brief Title:** Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis **Official Title:** Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis #### Organization Study ID Info **ID:** ACP-CAFE-MS-001 #### Organization **Class:** OTHER **Full Name:** Accelerated Cure Project for Multiple Sclerosis #### Secondary ID Infos **Domain:** Congressionally Directed Medical Research Programs (CDMRP) **ID:** CDMRP- MS220136 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2027-09-14 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-02-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Collaborators **Class:** FED **Name:** Congressionally Directed Medical Research Programs **Class:** FED **Name:** United States Department of Defense **Class:** OTHER **Name:** Charite University, Berlin, Germany **Class:** OTHER **Name:** University Medical Center Goettingen **Class:** FED **Name:** US Department of Veterans Affairs #### Lead Sponsor **Class:** OTHER **Name:** Accelerated Cure Project for Multiple Sclerosis #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** CAFE-MS will assess the effectiveness of two online programs for fatigue in multiple sclerosis (MS). Although they differ, both of these online programs contain information about MS and fatigue intended to help people with MS understand and manage their fatigue. This large-scale, decentralized clinical trial is projected to enroll 2,000 people with MS. The collaboration between iConquerMS and 5 Veterans Affairs (VA) sites in the MS Centers of Excellence is designed to ensure sufficient representation of people with MS from populations traditionally under-represented in MS clinical trials. The study is a 3-arm, randomized controlled clinical trial with study participation lasting 1 year. Two of the trial arms will include one of two online programs for managing fatigue in MS added to the trial participants' usual MS treatment, and the third arm will include usual MS treatment alone. The online program phase of the trial lasts for 6 months after randomization followed by a final study visit at 12 months. Participants in the usual MS treatment alone arm for the first 6 months will have an opportunity to choose one of the online programs for the final 6 months of the trial. ### Conditions Module **Conditions:** - Multiple Sclerosis - Fatigue ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Masking Description:** Participants will be blinded with respect to Program A and Program B. However, the third arm of the trial, Treatment as Usual, will not be blinded. Since outcome assessments are collected online via surveys, the outcome assessor is a blinded entity. **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 2000 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** An MS-specific fatigue management program, delivered as a stand-alone, fully automated intervention via an internet-browser. **Intervention Names:** - Device: Online Therapy for Fatigue **Label:** Fatigue Program A added to Treatment as Usual **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Fatigue Program B will use a web-based interface with similar design and functionality as Fatigue Program A. **Intervention Names:** - Device: Online Therapy for Fatigue **Label:** Fatigue Program B added to Treatment as Usual **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Label:** Treatment as Usual **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Fatigue Program A added to Treatment as Usual - Fatigue Program B added to Treatment as Usual **Description:** An MS-specific fatigue management program, delivered as a stand-alone, fully automated intervention via an internet-browser. **Name:** Online Therapy for Fatigue **Type:** DEVICE ### Outcomes Module #### Other Outcomes **Description:** The Treatment Acceptability questionnaire consists of seven 5-point Likert items covering affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy. **Measure:** Treatment Acceptability **Time Frame:** Day 180 #### Primary Outcomes **Description:** The scale contains 11 items covering physical fatigue (items 1-7) and mental fatigue (items 8-11). **Measure:** Chalder Fatigue Scale **Time Frame:** Day 180 #### Secondary Outcomes **Description:** The PROMIS FatigueMS-8a questionnaire has eight 5-point Likert scale items on different aspects of fatigue. **Measure:** PROMIS FatigueMS-8a **Time Frame:** Day 180 **Description:** PROMIS MS Health has 14 domains, each comprising four 5-point Likert scale items, covering mobility limitations, spasticity, reduced hand and arm function, fatigue, pain, numbness, cognition issues, sleep disturbances, bowel and bladder dysfunction, vision problems, dizziness and vertigo, sexual dysfunction, mood and emotional changes plus a single 5-point Likert scale item for overall health. **Measure:** PROMIS MS Health **Time Frame:** Day 180 **Description:** SymptoMScreen has twelve 7-point Likert scale items covering how each of the following MS symptoms affects everyday life activities: walking, hand function, spasticity, pain, sensory function, bladder control, fatigue, vision, dizziness, cognitive function, depression and anxiety. **Measure:** SymptoMScreen **Time Frame:** Day 180 **Description:** The Frenchay Activities Index (FAI) is a measure of instrumental activities of daily living (IADL) for use with patients with neurological disorders. The FAI assesses a broad range of activities associated with everyday life that the patient has participated in within the recent past, broken into 3 domains: domestic chores, leisure/work, and outdoor activities. **Measure:** Frenchay Activities Index **Time Frame:** Day 180 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Informed consent by person with MS * Living in the US * Age ≥ 22 * Confirmed diagnosis of MS by a physician, who is a neurologist or has access to a neurologist's statement of diagnosis * Fatigue Severity Scale score at or above eligibility threshold * Fluent in English * Willingness to engage in self-administration of an online intervention for 24 weeks and complete follow-up assessments * Access to the internet and e-mail with a compatible device (smartphone, computer, or tablet) * No MS relapse / no steroid treatment in the 4 weeks prior to answering the screening questionnaire (self-reported) * No disease-modifying therapeutic (DMT) started in the 4 weeks prior to answering the screening questionnaire (self-reported) Exclusion Criteria: * Unwilling or unable to consent * Refusal to saving, processing and forwarding of pseudonymized data * Concurrent participation in another interventional trial **Minimum Age:** 22 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Grace Okafor **Phone:** 781-487-0008 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## 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: M8364 - Name: Fatigue - Relevance: HIGH - As Found: Fatigue - 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: D000012598 - Term: Sclerosis - ID: D000005221 - Term: Fatigue ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441604 **Brief Title:** Extended-release Buprenorphine as a Novel Low-dose Induction Strategy **Official Title:** Extended-release Buprenorphine as a Novel Low-dose Induction Strategy #### Organization Study ID Info **ID:** 2024P001078 #### Organization **Class:** OTHER **Full Name:** Brigham and Women's Hospital ### Status Module #### Completion Date **Date:** 2026-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-01 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-04 **Type:** ESTIMATED #### Start Date **Date:** 2024-09 **Type:** ESTIMATED **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-06-01 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Utah #### Lead Sponsor **Class:** OTHER **Name:** Brigham and Women's Hospital #### Responsible Party **Investigator Affiliation:** Brigham and Women's Hospital **Investigator Full Name:** Joji Suzuki, MD **Investigator Title:** Director, Division of Addiction Psychiatry **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a clinical trial to characterize the safety and pharmacokinetics of using extended-release buprenorphine (XR-BUP) as a novel low-dose buprenorphine induction strategy. Individuals with a DSM-5 diagnosis of OUD (n=30) will be admitted to an inpatient unit to complete study procedures over the course of 5 days. Participants will receive fentanyl to prevent the emergence of withdrawal. Each participant will then receive a single injection of XR-BUP after which study staff will monitor for any precipitated withdrawal. **Detailed Description:** The approach is to conduct a single ascending dose trial in a controlled human laboratory setting with individuals with a DSM-5 diagnosis of OUD (n=30) actively using illicit fentanyl. After obtaining informed consent and establishing eligibility, 10 participants will be scheduled for an inpatient visit lasting 5 days-4 nights and receive XR-BUP when not yet experiencing any opioid withdrawal. Participants will receive fentanyl to prevent the emergence of withdrawal, and on the following morning, receive XR-BUP 16mg in single-blind fashion. If at least 90% successfully complete induction (success defined as experiencing no precipitated withdrawal) with the 16mg dose, then we will proceed with 10 more participants to receive the 24mg dose. If at least 90% successfully complete induction the 24mg dose, then we will proceed with 10 more participants to the 32mg dose. Timed blood samples will be collected in heparinized Vacutainer tubes via a catheter in the antecubital vein at baseline, and at 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after the XR-BUP injection. ### Conditions Module **Conditions:** - Opioid Use Disorder **Keywords:** - Opioid Use Disorder - Buprenorphine ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL **Intervention Model Description:** Single-blind, fixed-order, dose-escalation design. All participants (n=10) will first receive XR-BUP 16mg in single-blind fashion. If at least 90% successfully complete induction (success defined as experiencing no BPOW) with the 16mg dose, then we will proceed to the 24mg dose. If at least 90% successfully complete induction the 24mg dose, then we will proceed to the 32mg dose. ##### Masking Info **Masking:** SINGLE **Masking Description:** Only the participant will be masked. **Who Masked:** - PARTICIPANT **Primary Purpose:** OTHER #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The first 10 participants will receive XR-BUP 16mg in single-blind fashion. **Intervention Names:** - Drug: Extended-release Buprenorphine **Label:** 16mg Extended-Release Buprenorphine **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** After first 10 participants have been completed, the next 10 participants will receive 24mg in a single-blind fashion. **Intervention Names:** - Drug: Extended-release Buprenorphine **Label:** 24mg Buprenorphine **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** After the 20 participants have been completed, the next 10 participants will receive 32mg in a single-blind fashion. **Intervention Names:** - Drug: Extended-release Buprenorphine **Label:** 32mg Buprenorphine **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 16mg Extended-Release Buprenorphine - 24mg Buprenorphine - 32mg Buprenorphine **Description:** First 10 participants will receive XR-BUP 16mg in single-blind fashion. If at least 90% of the participants who received 16mg successfully complete induction (success defined as experiencing no BPOW),10 additional participants will receive a 24mg dose in a single blind fashion. If at least 90% who received 24mg successfully complete induction (success defined as experiencing no BPOW), 10 additional participants will receive a 32mg dose in a single blind fashion. **Name:** Extended-release Buprenorphine **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The primary outcome is the proportion of participants who successfully complete induction, defined as experiencing no BPOW. BPOW is a score of 5 or more on the Clinical Opiate Withdrawal Scale (COWS) **Measure:** Safety and tolerability of XR-Buprenorphine **Time Frame:** For the duration of the inpatient admission, lasting 4 days after receipt of study drug. **Description:** The area under the plasma concentration curves (AUC) of buprenorphine will be determined. Timed blood samples will be collected in EDTA anticoagulant Vacutainer tubes via venipuncture at baseline, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after the XR-BUP injection. Samples will be centrifuged and frozen until analysis. **Measure:** Plasma-concentration curves (AUC) of buprenorphine. **Time Frame:** Baseline, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after study drug administration. #### Secondary Outcomes **Description:** Plasma data will be used to calculate maximum plasma concentration (Cmax) for buprenorphine, norbuprenorphine, and their glucuronides. **Measure:** Maximum Plasma Concentration **Time Frame:** Baseline, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after study drug administration. **Description:** Plasma data will be used to calculate minimum plasma concentration (Cmin) for buprenorphine, norbuprenorphine, and their glucuronides. **Measure:** Minimum Plasma Concentration (Cmin), **Time Frame:** Baseline, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after study drug administration. **Description:** Plasma data will be used to calculate time to maximum plasma concentration (Tmax) for buprenorphine, norbuprenorphine, and their glucuronides. **Measure:** Time to Maximum Plasma Concentration **Time Frame:** Baseline, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after study drug administration. **Description:** Plasma data will be used to calculate elimination half-life (t1/2) for buprenorphine, norbuprenorphine, and their glucuronides. **Measure:** Elimination half-life **Time Frame:** Baseline, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after study drug administration. **Description:** DNA testing to check 3A4 activity levels. **Measure:** Buccal Swab **Time Frame:** will be done once at the baseline visit. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * English speaking adults aged 18 and above. * DSM-5 diagnosis of opioid use disorder. * Self-reporting use of illicit opioids in \>21 days in the prior 30 days. * Provide urine toxicology testing positive for fentanyl at baseline. Exclusion Criteria: * Seeking medication treatment for opioid use disorder with sublingual buprenorphine or methadone. * Received buprenorphine or methadone treatment in prior 30 days. * Current DSM-5 diagnosis of alcohol or sedative/hypnotic use disorder. * Physical dependence on alcohol or sedative/hypnotics. * Psychotic disorder, active suicidality or homicidally or any psychiatric condition that impair ability to provide informed Consent. * Requiring treatment with opioids for acute or chronic pain. * History of hypersensitivity or allergy to buprenorphine or fentanyl. * Pregnant or breastfeeding. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Joji Suzuki **Phone:** 6177325752 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000079524 - Term: Narcotic-Related Disorders - ID: D000019966 - Term: Substance-Related Disorders - ID: D000064419 - Term: Chemically-Induced Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC25 - Name: Substance Related Disorders - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12244 - Name: Opioid-Related Disorders - Relevance: HIGH - As Found: Opioid Use Disorder - ID: M2057 - Name: Narcotic-Related Disorders - Relevance: LOW - As Found: Unknown - ID: M21837 - Name: Substance-Related Disorders - Relevance: LOW - As Found: Unknown - ID: M30302 - Name: Chemically-Induced Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009293 - Term: Opioid-Related Disorders ### Intervention Browse Module - Ancestors - ID: D000000701 - Term: Analgesics, Opioid - ID: D000009294 - Term: Narcotics - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000700 - Term: Analgesics - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000009292 - Term: Narcotic Antagonists ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: NarcAntag - Name: Narcotic Antagonists - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M5317 - Name: Buprenorphine - Relevance: HIGH - As Found: Incision - ID: M4033 - Name: Analgesics, Opioid - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M12245 - Name: Narcotics - Relevance: LOW - As Found: Unknown - ID: M12243 - Name: Narcotic Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000002047 - Term: Buprenorphine ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441591 **Brief Title:** Clinical Outcome of Vinpocetine in Diabetic Nephropathy **Official Title:** The Effect of Vinpocetine on the Clinical Outcome of Patients With Diabetic Nephropathy #### Organization Study ID Info **ID:** 238 #### Organization **Class:** OTHER **Full Name:** Ain Shams University ### Status Module #### Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-01 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-06-01 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ain Shams University #### Responsible Party **Investigator Affiliation:** Ain Shams University **Investigator Full Name:** Salma Hesham Bahram **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this controlled, randomized, clinical trial is to evaluate the effect of vinpocetine on clinical outcomes on the diabetic nephropathy patients. The following will be evaluated; anthropometrics, kidney functions, glucose panel, lipid panel, ICAM-1, quality of life. Participants will receive either vinpocetine or placebo, twice daily for 3 months. **Detailed Description:** Diabetes mellitus affects around 537 million people globally, projected to reach over 700 million by 2045. Egypt is notably impacted, ranking tenth in prevalence and contributing significantly to chronic kidney disease, blindness, and stroke. Diabetic nephropathy (DN) arises as a severe complication, affecting about 50% of type 2 diabetes patients and leading to end-stage kidney disease. Its pathogenesis involves complex mechanisms like persistent hyperglycemia, inflammation, oxidative stress, and endothelial dysfunction, culminating in kidney damage and subsequently fibrosis. Current treatments focus on managing blood glucose, pressure, and lipid levels, often using drugs that target the renin-angiotensin-aldosterone system. However, these therapies aren't always sufficient to prevent progression to end-stage renal disease. Therefore, exploring new approaches is crucial. Vinpocetine, a derivative of Vinca minor leaves, is a selective inhibitor of phosphodiesterase type 1 (PDE1). It has noteworthy antioxidant, anti-inflammatory, and anti-apoptotic properties. Clinical and experimental studies suggest its potential in various conditions, including neurodegenerative disorders, cardiovascular diseases, and inflammation-related ailments. Notably, it has shown promising effects in improving endothelial function and reducing inflammatory markers like TNF-α and IL-6. In kidney injury models, Vinpocetine has demonstrated nephroprotective effects, improving kidney function markers, reducing albumin excretion, and decreasing renal hypertrophy. It can also exert its antioxidant effects through the restoration of the depleted GSH content, and the attenuation of the increase in MDA levels. In a clinical trial investigating the effect of vinpocetine in acute ischemic stroke patients, vinpocetine inhibited the upregulation of TNF-α, IL-6, MCP-1, ICAM-1, VCAM-1, as well as CRP in blood plasma. It also appears to impact atherosclerosis by positively affecting lipid profiles and reducing atherosclerosis lesion formation through mechanisms like inhibition of NF-κB and modulation of ox-LDL receptors. Based on vinpocetine's promising profile and minimal reported side effects, this work aims to investigate the Vinpocetine's potential in treating diabetic nephropathy and associated complications. ### Conditions Module **Conditions:** - Diabetic Kidney Disease - Diabetic Nephropathies **Keywords:** - Vinpocetine - Diabetic nephropathy - diabetic kidney disease - UACR - ICAM ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 64 **Type:** ESTIMATED **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Vinpocetine capsules, 30 mg, twice daily, with meals for 3 months **Intervention Names:** - Drug: Vinpocetine - Drug: Standard Therapy **Label:** Vinpocetine + Standard Therapy **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Placebo, twice daily, with meals for 3 months **Intervention Names:** - Drug: Standard Therapy - Other: Placebo **Label:** Placebo + Standard Therapy **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Vinpocetine + Standard Therapy **Description:** Vinca derivative of apovincamine, phosphodiestrase 1 inhibitor, sodium-gated voltage channel **Name:** Vinpocetine **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo + Standard Therapy - Vinpocetine + Standard Therapy **Description:** Anti-hypertensive and anti-diabetic medications according to the the institution's protocol **Name:** Standard Therapy **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Placebo + Standard Therapy **Description:** Starch-filled capsules, matching those of the intervention **Name:** Placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** assessment of the amount of albumin excreted in urine **Measure:** level of Albuminuria **Time Frame:** Samples will be measured at baseline and after 12 weeks #### Secondary Outcomes **Description:** The urine ACR is calculated by dividing the urine albumin concentration by the urine creatinine concentration to account for differences in urine volume and more closely approximate the gold standard, 24-hour urine albumin excretion. **Measure:** Albumin: creatinine ratio (ACR) **Time Frame:** Samples will be measured at baseline and after 12 weeks **Description:** assessment of the serum level of creatinine **Measure:** Serum Creatinine **Time Frame:** Samples will be measured at baseline and after 12 weeks **Description:** assessment of the level of blood urea nitrogen in serum **Measure:** Blood urea nitrogen **Time Frame:** Samples will be measured at baseline and after 12 weeks **Description:** assessment of the level of glycated hemoglobin **Measure:** Hemoglobin A1c **Time Frame:** Samples will be measured at baseline and after 12 weeks **Description:** Evaluation of blood level glucose after 8-hrs fasting and 2-hrs postprandial **Measure:** Fasting and postprandial blood glucose **Time Frame:** Samples will be measured at baseline and after 12 weeks **Description:** Serum Low-density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Triglycerides **Measure:** Lipid panel **Time Frame:** Samples will be measured at baseline and after 12 weeks **Description:** The BMI will be calculated using the following formula BMI=Weight(kg)/ height(m)\^2 **Measure:** Body Mass index (BMI) **Time Frame:** Samples will be measured at baseline and after 12 weeks **Description:** Serum ICAM-1 using ELISA **Measure:** Assessment of endothelial functions **Time Frame:** Samples will be measured at baseline and after 12 weeks **Description:** Quality of Life (QoL) assessment using Diabetes-39 (D-39) Questionnaire. The D-39 questionnaire is a multi-dimensional, self-administrating, diabetes-specific scale. It consists of 39 items in five domains, namely energy, and mobility (15 items), diabetes control (12 items), anxiety and worry (4 items), social and peer burden (5 items), and sexual functioning (3 items). Scores are marked on a seven-point scale ranging from 1 (not affected at all) to 7 (extremely affected). The raw score resulting from the summation of each dimension will then be transformed linearly to 0 to 100 scales, using the following formula: (Raw score - minimum value)/(maximum value - minimum value) × 100 A score of 0 indicates the least impact on QoL, and a score of 100 indicates the maximum impact on QoL **Measure:** Quality of life (QoL) Assessment **Time Frame:** Samples will be measured at baseline and after 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥ 18 years, * Type II diabetic patients with CKD stage 3 (eGFR = 30 - 59 ml/min) or stage 4 (eGFR 15-29 ml/min), * Albumin/Creatinine ratio (ACR): 30 - 300 μg /mg (microalbuminuria), * Stable standard therapy for at least three months prior to inclusion in the study. Exclusion Criteria: * Kidney donor or recipient, * Active malignancy, * Pregnancy or breastfeeding, * Known intolerance or hypersensitivity to VPN, * Participation in other interventional trials, * Patients with inadequate liver function (ALT and AST three times greater than the upper normal limits), * Patients with severe comorbidities * Patients receiving warfarin **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Tamer El Said **Phone:** 201227366062 **Role:** CONTACT #### Locations **Location 1:** **City:** Cairo **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Tamer El Said - **Phone:** 01227366062 - **Role:** CONTACT **Country:** Egypt **Facility:** Ain Shams University Hospital **State:** Abbasseia **Status:** NOT_YET_RECRUITING **Zip:** 11588 **Location 2:** **City:** Cairo **Contacts:** ***Contact 1:*** - **Name:** Tamer El Said - **Phone:** 01227366062 - **Role:** CONTACT **Country:** Egypt **Facility:** Ain Shams Hospitals **State:** Abbasseya **Status:** RECRUITING **Zip:** 11588 ## 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: 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: 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: M7123 - Name: Diabetic Nephropathies - Relevance: HIGH - As Found: Diabetic Nephropathy - 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 ### Intervention Browse Module - Ancestors - ID: D000010726 - Term: Phosphodiesterase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000014665 - Term: Vasodilator Agents - ID: D000018696 - Term: Neuroprotective Agents - ID: D000020011 - Term: Protective Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018697 - Term: Nootropic Agents ### Intervention Browse Module - Browse Branches - Abbrev: VaDiAg - Name: Vasodilator Agents - Abbrev: NeuroAg - Name: Neuroprotective Agents - Abbrev: NootAg - Name: Nootropic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: AnAg - Name: Antihypertensive Agents ### Intervention Browse Module - Browse Leaves - ID: M228476 - Name: Vinpocetine - Relevance: HIGH - As Found: Occlusal Caries - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown - ID: M4277 - Name: Antihypertensive Agents - 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: M17412 - Name: Vasodilator Agents - Relevance: LOW - As Found: Unknown - ID: M20773 - Name: Neuroprotective Agents - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown - ID: M20774 - Name: Nootropic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000013983 - Term: Vinpocetine ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441578 **Brief Title:** A Survey of Recombinant ADAMTS13 in Participants With Congenital Thrombotic Thrombocytopenic Purpura **Official Title:** Special Drug Use Surveillance of ADZYNMA Intravenous 1500 (All-Case Investigation) #### Organization Study ID Info **ID:** TAK-755-4005 #### Organization **Class:** INDUSTRY **Full Name:** Takeda ### Status Module #### Completion Date **Date:** 2032-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2032-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Takeda #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is a survey in Japan of recombinant ADAMTS13 used to treat or to prevent participants with congenital thrombotic thrombocytopenic purpura (cTTP). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. The main aim of the study is to check for side effects related from recombinant ADAMTS13 and to check if recombinant ADAMTS13 improves or prevents cTTP. During the study, participants with cTTP will take recombinant ADAMTS13 intravenous injection according to their clinic's standard practice. The study doctors will check for side effects from recombinant ADAMTS13 for 18 months. ### Conditions Module **Conditions:** - Thrombotic Thrombocytopenic Purpura (TTP) ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive recombinant ADAMTS13 intravenous injection. **Intervention Names:** - Drug: Recombinant ADAMTS13 **Label:** Recombinant ADAMTS13 ### Interventions #### Intervention 1 **Arm Group Labels:** - Recombinant ADAMTS13 **Description:** Recombinant ADAMTS13, Intravenous injection **Name:** Recombinant ADAMTS13 **Other Names:** - ADZYNMA Intravenous 1500 - TAK-755 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE) **Time Frame:** Up to 18 Months #### Secondary Outcomes **Description:** Percent change in platelet count from baseline at the end of treatment will be reported. **Measure:** Percent Change in Observed Platelet Count from Baseline at the End of Treatment **Time Frame:** Up to 18 Months **Description:** Percent change in ADAMTS13 activity from baseline at the end of treatment will be reported. **Measure:** Percent Change in Observed ADAMTS13 Activity from Baseline at the End of Treatment **Time Frame:** Up to 18 Months **Description:** Percent change in ADAMTS13 inhibitor from baseline at the end of treatment will be reported. **Measure:** Percent Change in Observed ADAMTS13 Inhibitor from Baseline at the End of Treatment **Time Frame:** Up to 18 Months **Description:** Number of participants with TTP events on periodic replacement therapy will be reported. **Measure:** Number of Participants with Thrombotic Thrombocytopenic Purpura (TTP) Events on Periodic Replacement Therapy **Time Frame:** Up to 18 Months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: - All participants with congenital thrombotic thrombocytopenic purpura (cTTP), treated with recombinant ADAMTS13 Exclusion Criteria: - None **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** The population of this survey are all participants who meet the inclusion/exclusion criteria. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Takeda Contact **Phone:** +1-877-825-3327 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Takeda **Name:** Study Director **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement. **Description:** Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES **URL:** https://vivli.org/ourmember/takeda/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001778 - Term: Blood Coagulation Disorders - ID: D000006402 - Term: Hematologic Diseases - ID: D000006470 - Term: Hemorrhage - ID: D000010335 - Term: Pathologic Processes - ID: D000012877 - Term: Skin Manifestations - ID: D000057049 - Term: Thrombotic Microangiopathies - ID: D000013921 - Term: Thrombocytopenia - ID: D000001791 - Term: Blood Platelet Disorders - ID: D000095542 - Term: Cytopenia - ID: D000007154 - Term: Immune System Diseases - ID: D000019851 - Term: Thrombophilia ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - 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: M14547 - Name: Purpura - Relevance: HIGH - As Found: Purpura - ID: M14550 - Name: Purpura, Thrombocytopenic - Relevance: HIGH - As Found: Thrombocytopenic Purpura - ID: M14551 - Name: Purpura, Thrombotic Thrombocytopenic - Relevance: HIGH - As Found: Thrombotic Thrombocytopenic Purpura - ID: M21977 - Name: Hemostatic Disorders - Relevance: LOW - As Found: Unknown - ID: M5059 - Name: Blood Coagulation Disorders - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M9556 - Name: Hemorrhage - Relevance: LOW - As Found: Unknown - ID: M15680 - Name: Skin Manifestations - Relevance: LOW - As Found: Unknown - ID: M28682 - Name: Thrombotic Microangiopathies - Relevance: LOW - As Found: Unknown - ID: M16680 - Name: Thrombocytopenia - Relevance: LOW - As Found: Unknown - ID: M5072 - Name: Blood Platelet Disorders - Relevance: LOW - As Found: Unknown - ID: M3170 - Name: Cytopenia - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M21737 - Name: Thrombophilia - Relevance: LOW - As Found: Unknown - ID: T1552 - Name: Congenital Thrombotic Thrombocytopenic Purpura - Relevance: LOW - As Found: Unknown - ID: T5642 - Name: Thrombotic Thrombocytopenic Purpura, Acquired - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011693 - Term: Purpura - ID: D000011696 - Term: Purpura, Thrombocytopenic - ID: D000011697 - Term: Purpura, Thrombotic Thrombocytopenic ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441565 **Brief Title:** Fruquintinib With or Without HAI-FOLFOX for Refractory Colorectal Cancer **Official Title:** Fruquintinib Plus Arterial Infusion Therapy With Hepatic FOLFOX for Refractory Colorectal Cancer: The FAITH Randomized Clinical Trial #### Organization Study ID Info **ID:** FAITH-CRC #### Organization **Class:** OTHER **Full Name:** Sun Yat-sen University ### Status Module #### Completion Date **Date:** 2029-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-12-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-24 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-24 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Sun Yat-sen University #### Responsible Party **Investigator Affiliation:** Sun Yat-sen University **Investigator Full Name:** Yuhong Li **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The objective of this clinical trial is to evaluate the efficacy and safety of combining fruquintinib with hepatic artery infusion (HAI)-FOLFOX in the treatment of refractory colorectal cancer with liver metastasis. **Detailed Description:** Colorectal cancer (CRC) is the third most common cancer globally, accounting for approximately 10% of all cancer cases, and is the second leading cause of cancer-related deaths worldwide. Significant advancements have been made in treating metastatic colorectal cancer (mCRC) over the past two decades, primarily due to continuous improvements in first-line treatment regimens. However, treatment options are relatively limited for patients with mCRC who do not respond to standard first-line treatments or who develop chemotherapy resistance. Approved second-line treatments include regorafenib, fruquintinib, and TAS-102, but their reported efficacy and overall survival (OS) rates are not ideal. Fruquintinib is a novel small-molecule anticancer drug classified as a quinazoline, acting as a potent and highly selective inhibitor of vascular endothelial growth factor receptor (VEGFR) tyrosine kinase. Preclinical and clinical studies conducted in China and the United States have demonstrated significant anticancer activity of fruquintinib in solid tumors. The prospective randomized controlled clinical study FRESCO-2 showed that fruquintinib significantly improved median OS (7.4 months vs. 4.8 months; P \< 0.001) and median progression-free survival (PFS) (3.7 months vs. 1.8 months; P \< 0.001) compared to the placebo group. These results are consistent with previous FRESCO study findings. Although these studies provide strong evidence for fruquintinib in treating refractory mCRC patients, the overall improvement in survival is limited, with a 6-month PFS rate of only about 20% (FRESCO: 19.3%, FRESCO-2: 22.7%). Thus, there is a need for new second-line treatment options to further enhance efficacy and survival in refractory mCRC patients. Recent studies have shown that combining fruquintinib with paclitaxel as a second-line therapy demonstrates good efficacy and safety in advanced gastric cancer patients. Additionally, fruquintinib combined with sintilimab has shown some antitumor activity, particularly in mCRC patients with pMMR status. Therefore, combining fruquintinib with other anticancer drugs might offer a new treatment direction for refractory mCRC. Liver metastasis is the most common form of metastasis in colorectal cancer. Normal liver tissue primarily receives blood supply from the portal vein, while colorectal cancer liver metastases mainly receive blood from the hepatic artery. This dual blood supply characteristic has led to the development of hepatic artery infusion (HAI), a treatment method delivering high concentrations of chemotherapy drugs directly to liver metastases, minimizing toxicity to normal liver tissue and surrounding organs. For mCRC patients with chemotherapy resistance and liver-dominant metastasis, treatments such as yttrium-90 resin microsphere selective internal radiation therapy (Y-90 SIRT) are recommended by NCCN guidelines, although Y-90 SIRT is not yet widely available domestically. Fluorouracil (5-FU) and floxuridine (FUDR) are the most commonly used drugs for hepatic artery infusion chemotherapy (HAIC), with high first-pass metabolism rates and short half-lives, suitable for HAI. Studies have reported that HAIC combined with systemic chemotherapy shows high efficacy (76%) and a conversion surgery rate of 47% in mCRC patients who have undergone multiple lines of treatment. Cercek et al. found that mCRC patients resistant to at least three standard systemic treatments (n = 57) benefited from HAI-FUDR, with partial response (PR) and stable disease (SD) rates of 33% and 54%, respectively. However, many countries, including China, no longer produce FUDR injections, necessitating the search for alternative drugs or combinations for HAIC. Compared to systemic oxaliplatin chemotherapy, hepatic artery infusion chemotherapy with oxaliplatin has a high hepatic extraction rate of 0.47 and good safety. A phase II clinical study using oxaliplatin HAIC combined with intravenous 5-FU as first-line treatment showed an objective response rate (ORR) of 64% and a median OS of 27 months in patients with unresectable CRLM. Another study by the same team found that oxaliplatin HAIC had a disease control rate of 87% (n = 39) in CRLM patients who had previously received FOLFIRI or FOLFOX treatments, with 62% achieving partial response, suggesting that oxaliplatin-based HAIC could overcome resistance to previous oxaliplatin-containing systemic therapies. Due to these promising results, several prospective randomized clinical studies are currently underway, such as the phase II SULTAN study investigating oxaliplatin HAIC combined with systemic FOLFIRI as salvage therapy in patients with unresectable localized mCRC after systemic chemotherapy induction. Recent retrospective studies and randomized clinical trials have confirmed that HAI-FOLFOX alone or in combination with other drugs significantly improves the prognosis of patients with advanced hepatocellular carcinoma. Our previous retrospective analysis of 21 patients with recurrent, unresectable CRLM after multiple lines of treatment, who received oxaliplatin + 5-FU (FOLFOX) or FUDR HAIC with or without systemic chemotherapy, showed an ORR of 28.6%, with 7 patients successfully undergoing conversion surgery. The median PFS was 6.3 months, with a 6-month PFS rate of 61.9%. However, due to the limited sample size and retrospective design of our study, caution is needed when generalizing these results. To address the limitations of previous studies and provide more robust evidence, this prospective randomized clinical study will investigate the synergistic effects of combining fruquintinib with HAI-FOLFOX. The aim is to determine whether this combination improves the efficacy in CRLM patients who have progressed after standard systemic chemotherapy compared to fruquintinib monotherapy. By systematically observing a larger patient sample, we hope to understand the potential advantages of this treatment regimen in improving PFS, ORR, and OS. This prospective study will provide valuable insights into the potential clinical benefits of fruquintinib combined with HAI-FOLFOX, paving the way for new treatment strategies and advancing personalized treatment for patients with refractory metastatic colorectal cancer. ### Conditions Module **Conditions:** - Colorectal Cancer **Keywords:** - Colorectal cancer - Hepatic Arterial Infusion Chemotherapy - Randomized Clinical Study - Progression Free Surivival - Safety Profile ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Participants will be randomly assigned in a 1:1 ratio to either the fruquintinib monotherapy group (control group) or the fruquintinib plus HAI-FOLFOX treatment group (experimental group) ##### Masking Info **Masking:** NONE **Masking Description:** Open label **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 84 **Type:** ESTIMATED **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants in the fruquintinib monotherapy group will undergo a treatment cycle every 4 weeks, taking 4 mg orally once daily for 3 weeks, followed by a 1-week break. **Intervention Names:** - Drug: Fruquintinib **Label:** Fruquintinib monotherapy group (control group) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** The experimental group will receive fruquintinib plus HAI-FOLFOX, with HAI-FOLFOX given every 2 weeks **Intervention Names:** - Drug: Fruquintinib - Drug: Fluorouracil - Drug: Oxaliplatin **Label:** Fruquintinib plus HAI-FOLFOX treatment group (experimental group) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Fruquintinib monotherapy group (control group) - Fruquintinib plus HAI-FOLFOX treatment group (experimental group) **Description:** A treatment cycle of 4 weeks, with 4 mg orally once daily for 3 weeks, followed by a 1-week break **Name:** Fruquintinib **Other Names:** - Fruzaqla **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Fruquintinib plus HAI-FOLFOX treatment group (experimental group) **Description:** 2.8 g/m² (400mg bolus + 2.4g/m² continuous infusion) given every 2 weeks through hepatic arterial infusion **Name:** Fluorouracil **Other Names:** - 5-FU **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Fruquintinib plus HAI-FOLFOX treatment group (experimental group) **Description:** 85 mg/m² given every 2 weeks through hepatic arterial infusion **Name:** Oxaliplatin **Other Names:** - L01XA03 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The proportion of patients who remain alive and whose disease does not progress over a period of six months after starting treatment **Measure:** 6-month progression-free survival **Time Frame:** Assessed 6 months following treatment initiation #### Secondary Outcomes **Description:** Duration of time during which liver metastases remain stable without progression. **Measure:** Liver Lesion Progression-Free Survival **Time Frame:** Assessed throughout the study duration (5 years) **Description:** Duration of time during which metastases outside the liver remain stable without progression. **Measure:** Extrahepatic Lesion Progression-Free Survival (PFS) **Time Frame:** Assessed throughout the study duration (5 years) **Description:** Proportion of patients achieving partial or complete response in liver metastases per RECIST criteria. **Measure:** Liver Lesion Objective Response Rate **Time Frame:** Assessed throughout the study duration (5 years) **Description:** Proportion of patients achieving partial or complete response in extrahepatic metastases per RECIST criteria. **Measure:** Extrahepatic Lesion Objective Response Rate (ORR) **Time Frame:** Assessed throughout the study duration (5 years) **Description:** Time from treatment initiation to death from any cause or censored due to loss to follow up **Measure:** Overall Survival **Time Frame:** Assessed throughout the study duration (5 years) **Description:** Assessment of adverse events and their severity according to NCI CTCAE version 5.0 criteria. **Measure:** Adverse events (catheter related and chemotherapy related) **Time Frame:** Assessed throughout the study duration (5 years) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged between 18 and 75 years. * Histologically confirmed colorectal adenocarcinoma. * Radiologically or pathologically confirmed liver metastasis. * At least one measurable lesion (per RECIST v1.1 criteria). * No extrahepatic metastasis confirmed by CT, MRI, or PET/CT (if necessary). Patients with minimal extrahepatic metastatic burden (defined as the presence of lung metastasis and/or lymph node metastasis with lung lesion diameter not exceeding 1 cm, and lymph node metastasis with the longest diameter less than 2 cm) can be included. * Disease progression within 3 months or intolerance to standard treatment with fluoropyrimidine, irinotecan, oxaliplatin combined with targeted therapy (including bevacizumab and cetuximab (RAS/BRAF wild-type)), with previous oxaliplatin-induced neurotoxicity \< Grade 2. * Normal hematologic function (platelets \>90×10\^9/L; white blood cells \>3×10\^9/L; neutrophils \>1.5×10\^9/L). * Serum bilirubin ≤1.5 times the upper limit of normal (ULN), transaminases ≤5 times ULN, alkaline phosphatase ≤2.5 times ULN, no ascites, coagulation function: prothrombin time (PT) ≤1.5 ULN; international normalized ratio (INR) ≤1.5 ULN; activated partial thromboplastin time (APTT) ≤1.5 ULN, albumin ≥35 g/L. * Child-Pugh grade A liver function. * Serum creatinine less than ULN, or calculated creatinine clearance \>50 ml/min (using Cockcroft-Gault formula). * ECOG performance status 0-1. * Expected survival \>3 months. * Signed written informed consent. * Willing and able to undergo follow-up until death or study completion/termination. Exclusion Criteria: * Severe arterial embolism. * Bleeding tendency or coagulation disorders. * Hypertensive crisis or hypertensive encephalopathy. * Severe uncontrolled systemic complications such as infection or diabetes. * Clinically significant cardiovascular diseases such as cerebrovascular accident (within 6 months prior to enrollment), myocardial infarction (within 6 months prior to enrollment), uncontrolled hypertension despite appropriate medical therapy, unstable angina, congestive heart failure (NYHA Class 2-4), or arrhythmias requiring medication. * History or physical examination indicative of central nervous system diseases (e.g., primary brain tumors, uncontrolled seizures, any history of brain metastasis or stroke). * Other malignancies within the past 5 years (except for radically treated basal cell carcinoma of the skin and/or carcinoma in situ of the cervix). * Received any investigational drug treatment within 28 days prior to the study. * Residual toxicity from previous chemotherapy (excluding alopecia), such as peripheral neuropathy ≥ Grade 2 (NCI CTCAE v5.0), if considering an oxaliplatin-containing regimen. * Allergy to any of the study drugs. * Pregnant or breastfeeding women. * Women of childbearing potential not using or refusing to use effective non-hormonal contraception (intrauterine device, barrier method combined with spermicide, or sterilization) or men with reproductive potential. * Inability or unwillingness to comply with the study protocol. * Presence of any other diseases, functional impairment due to metastatic lesions, or findings on physical examination suggesting a contraindication to the use of the study drugs or putting the participant at high risk for treatment-related complications. **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:** Yuhong Li, PhD **Phone:** 87342487 **Phone Ext:** 020 **Role:** CONTACT #### Locations **Location 1:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yu-hong Li, MD, Ph D - **Phone:** 87342487 - **Phone Ext:** 020 - **Role:** CONTACT ***Contact 2:*** - **Name:** Yu-hong Li, MD, Ph D - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** Sun Yat-sen University Cancer Center **State:** Guangdong **Status:** RECRUITING **Zip:** 510060 ### IPD Sharing Statement Module **Description:** Data and materials used in this study can be made available following study completion upon reasonable request to the corresponding author, subject to ethical and legal considerations and applicable data-sharing agreements. **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007414 - Term: Intestinal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000012002 - Term: Rectal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M20559 - Name: Disease Progression - Relevance: LOW - As Found: Unknown - ID: M17890 - Name: Colorectal Neoplasms - Relevance: HIGH - As Found: Colorectal Cancer - ID: M10448 - Name: Intestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M14844 - Name: Rectal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015179 - Term: Colorectal Neoplasms ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1674 - Name: Oxaliplatin - Relevance: HIGH - As Found: Min - ID: M8600 - Name: Fluorouracil - Relevance: HIGH - As Found: According - ID: M4281 - Name: Antimetabolites - 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 ### Intervention Browse Module - Meshes - ID: D000077150 - Term: Oxaliplatin - ID: D000005472 - Term: Fluorouracil ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441552 **Acronym:** RESTRO **Brief Title:** The Natural History of Recovery After Stroke **Official Title:** Learning the Natural History of Recovery After Stroke - Cognitive, Motor and Sensory Function #### Organization Study ID Info **ID:** ADINEGEV-2023_106 #### Organization **Class:** OTHER **Full Name:** Adi Negev-Nahalat Eran #### Secondary ID Infos **Domain:** KB6NZDMMP3N8 **ID:** SIS70023GR0026 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2026-02 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-01 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-02 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-01 **Type:** ACTUAL **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-04-30 **Study First Submit QC Date:** 2024-06-01 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Ben-Gurion University of the Negev **Class:** OTHER **Name:** Technion, Israel Institute of Technology #### Lead Sponsor **Class:** OTHER **Name:** Adi Negev-Nahalat Eran #### 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 longitudinal observational study is to learn the course of recovery after stroke. Specifically, in this study we will learn and describe the changes in cognitive, motor and sensory function over time in stroke patients. **Detailed Description:** This study constitutes the first step in the RESTRO project: Evaluation of an accessible and affordable neurorehabilitation program to promote recovery and to enhance the quality of life after stroke. In this study, we will monitor sensorimotor and cognitive functions of Stroke patients along the first 6 to 12 month following their stroke. Data from three primary sites will be collected and compared in several time points, and its relation to the type and intensity of the rehabilitation program, usually provided in each site, will be tested. ### Conditions Module **Conditions:** - Cerebral Vascular Accident (CVA)/Stroke ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Year ### Arms Interventions Module #### Arm Group 1 **Description:** Non-interventional group, recruited at Adi-Negev Rehabilitation Center, Israel. **Intervention Names:** - Other: non-interventional **Label:** Ofakim #### Arm Group 2 **Description:** Non-interventional group, recruited at Rambam Health Care Campus, Israel. **Intervention Names:** - Other: non-interventional **Label:** Haifa #### Arm Group 3 **Description:** Non-interventional group, recruited through Green Land Society for Health Development, Palestine. **Intervention Names:** - Other: non-interventional **Label:** Hebron ### Interventions #### Intervention 1 **Arm Group Labels:** - Haifa - Hebron - Ofakim **Description:** non-interventional **Name:** non-interventional **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Fugl-Meyer Assessment: Motor score is on a 0-100 scale. High score is better. **Measure:** Fugl-Meyer Assessment (FMA) **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Action Research Arm Test Score is on a 0-57 scale. High score is better. **Measure:** Action Research Arm Test (ARAT) **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Outcome is the average walking velocity over 10 meters. Measured in m/sec. **Measure:** 10-meter walk test (10MWT) **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year #### Secondary Outcomes **Description:** measure of stroke severity on a 0-42 scale, with lower scores indicates lower severity (lower is better). **Measure:** National Institutes of Health Stroke Scale (NIHSS) **Time Frame:** Baseline (<3weeks) **Description:** This is a self-reported ability perception scale. Outcome range is 0-130 with higher scores indicate a better self-perceived ability. **Measure:** The Stroke Self-Efficacy Questionnaire (SSEQ) **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** This is an upper extremity dexterity test. Outcome is the time taken to complete the task. Measured in sec. **Measure:** The Nine Hole Peg Test (NHPT) **Time Frame:** Baseline (<3weeks), 1-year **Description:** This is an upper extremity dexterity test. Outcome is the time taken to complete the task. Measured in sec. **Measure:** The Functional Dexterity Test (FDT) **Time Frame:** Baseline (<3weeks), 1-year **Description:** This is an instrument aimed at detecting visual neglect. In this study we use only two subsections of the test: star cancellation (scored on a 0-54 scale) and representational drawing (scored on a 0-3 scale). For both, higher scores are better. **Measure:** The Behavioral Inattention Test (BIT) **Time Frame:** Baseline (<3weeks) **Description:** This instrument is used to detect spasticity (increased muscle tone). Outcome is 0-4 scale, with lower scores means better outcome (less spasticity). **Measure:** The Ashworth scale **Time Frame:** Baseline (<3weeks) **Description:** To measure fingers kinetics, we will use a custom-built device that measures finger force for flexion and extension. Outcome is the force in Newtons (N) generated by each finger. **Measure:** Kinetics-fingers1 **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** To measure fingers kinetics, we will use a custom-built device that measures finger force for flexion and extension. Outcome measure is the Individuation Index, measured in arbitrary units (a.u.). The individuation index is calculated as the ratio between the forces generated by the non-instructed digits and the force generated by the instructed digit. This index evaluates the ability to generate force in each digit independently of the other digits. **Measure:** Kinetics-fingers2 **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Grip force will be measured using the microFET Digital HandGrip Dynamometer (Hoggan Scientific). Outcome is the maximal force in Newtons. **Measure:** Kinetics-grip **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Kinematic measurements of upper extremity reaching task: Kinematic measures will be extracted using markerless pose estimation algorithms (such as OpenPose and MediaPipe). Reaching error (distance of the hand from the target) and reaching extent (maximum distance of the wriest from the shoulder). Measured in mm. **Measure:** Kinematics-reaching **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Kinematic measurements of upper extremity reaching tasks: Kinematic measures will be extracted using markerless pose estimation algorithms (such as OpenPose and MediaPipe). Reaching duration. Measured in seconds. **Measure:** Kinematics-duration **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Kinematic measurements of upper extremity reaching tasks: Kinematic measures will be extracted using markerless pose estimation algorithms (such as OpenPose and MediaPipe). Reaching smoothness as the integrated jerk (as described by Platz et al. 1994, Dimensions are L\^2/T\^6) and the spectral arch length (as described by Balasubramanian et al. 2015). **Measure:** Kinematics-smoothness **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Kinematic measurements of upper extremity reaching tasks: Kinematic measures will be extracted using markerless pose estimation algorithms (such as OpenPose and MediaPipe). Inter-joint coordination will be measured through computing the cross correlation between elbow, writs and shoulder joint angles and the proportion of time when joints flexed or extend together. Arbitrary units. **Measure:** Kinematics-Inter-joint coordination **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Number of rehabilitative sessions per week, in total and for each modality separately (e.g., physical therapy, occupational therapy, etc.) **Measure:** Rehabilitation-intensity **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Time, in minutes, of each therapy session. **Measure:** Rehabilitation-time **Time Frame:** one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Period of time (in month) for which the participant received therapy. **Measure:** Rehabilitation-period **Time Frame:** one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Age at admission, in years. **Measure:** Supporting data-age **Time Frame:** Baseline **Description:** Biological Male or Female **Measure:** Supporting data-sex **Time Frame:** Baseline **Description:** time from stroke onset in days **Measure:** Supporting data-time1 **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** other time periods (e.g., inpatient time, rehabilitation duration, etc.) in Months. **Measure:** Supporting data-time2 **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Height in cm **Measure:** anthropometric data-height **Time Frame:** Baseline **Description:** Weight in kg **Measure:** anthropometric data-weight **Time Frame:** Baseline **Description:** affected brain side: L/R/Both affected body side: L/R/Both hand dominance: L/R leg dominance: L/R **Measure:** supporting data-directional **Time Frame:** Baseline **Description:** Any relevant history of illnesses. **Measure:** supporting data-medical history **Time Frame:** Baseline **Description:** Montreal Cognitive Assessment (MoCA). 0-30 scale with higher values indicate better cognitive state. **Measure:** Cognition-impairment **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Percent correct responses in an anti-saccade computerized task. **Measure:** Cognition-inhibition1 **Time Frame:** one or more of : Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Reaction time (in msec) in an anti-saccade computerized task. **Measure:** Cognition-inhibition2 **Time Frame:** one or more of : Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Time taken to complete the TUG task. Measured in seconds. **Measure:** Timed up and Go test (TUG) **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** This is a questioner aimed at evaluating the attentional profile of the patient during walking. It has several subscales measured on a Likert 5-point scale. Total score range is 11-55 with lower values indicate better outcome. **Measure:** Gait Specific attentional profile (G-SAP) **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Gait analysis while participants are walking on a treadmill (Zebris FDM-T Treadmill, Zebris Medical GmbH, Germany) with an embedded force sensors array. Temporal measures include step and stride time. Measured in seconds. **Measure:** Gait analysis-temporal **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Gait analysis while participants are walking on a treadmill (Zebris FDM-T Treadmill, Zebris Medical GmbH, Germany) with an embedded force sensors array. Spatial measures include step and stride length and width. Measured in meters. **Measure:** Gait analysis-spatial **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Gait analysis while participants are walking on a treadmill (Zebris FDM-T Treadmill, Zebris Medical GmbH, Germany) with an embedded force sensors array. Steadiness is measured by calculating the maximal Lyapunov exponent of the center of pressure dynamics (as described by Rosenstein et al. 1993). Units of measure are arbitrary. **Measure:** Gait analysis-steadiness **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Gaze behavior during walking using a mobile eye-tracker (Pupil Invisible, Pupil Labs, Germany). Head, eye and gaze (head and eye combined) angles on the sagittal and horizontal planes will be measured. Outcome in degrees. **Measure:** Gaze-angle1 **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Gaze behavior during walking using a mobile eye-tracker (Pupil Invisible, Pupil Labs, Germany). Gaze angles will be measured relative to the vanishing point. Outcome in %. **Measure:** Gaze-angle2 **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Gaze behavior during walking using a mobile eye-tracker (Pupil Invisible, Pupil Labs, Germany). Time spent looking onto the walking surface. Outcome in %. **Measure:** Gaze-downward **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Gaze behavior during walking using a mobile eye-tracker (Pupil Invisible, Pupil Labs, Germany). Look-ahead distance. Outcome in meters. **Measure:** Gaze-look-ahead distance **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Berg Balance Scale (BBS) measured on a 0-56 scale with higher score represent better outcome. **Measure:** Balance-Berg **Time Frame:** baseline **Description:** Postural Sway (Zebris FDM-T Treadmill, Zebris Medical GmbH, Germany). Outcome is sway range in mm. **Measure:** Balance-postural steadiness1 **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Postural Sway (Zebris FDM-T Treadmill, Zebris Medical GmbH, Germany). Outcome is sway velocity in mm/sec. **Measure:** Balance-postural steadiness2 **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Postural Sway (Zebris FDM-T Treadmill, Zebris Medical GmbH, Germany). Outcome is sway area in mm\^2. **Measure:** Balance-postural steadiness3 **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Postural Sway (Zebris FDM-T Treadmill, Zebris Medical GmbH, Germany). Outcome is the short-term diffusion coefficients, as described by Collins and De-Luka (1993), measured in mm\^2/sec. **Measure:** Balance-postural steadiness4 **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Monitoring habitual activity during hospital stay. Time spent walking, sitting and laying in hours/day. Measured over 3-5 consecutive days. **Measure:** Habitual activity1 **Time Frame:** one or more of :Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Monitoring habitual activity during hospital stay. Distance walked in meters/day. Measured over 3-5 consecutive days. **Measure:** Habitual activity2 **Time Frame:** one or more of :Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Sensory acuity will be measured using Semmes-Weinstein monofilament. Outcome is in grams. **Measure:** Sensory-tactile **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** LEMOCOT- Lower Extremity Motor Coordinating Test. Outcome is the number of touches (count). **Measure:** Coordination-LE1 **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** LEMOCOT- Lower Extremity Motor Coordinating Test. Outcome is the touches' errors (distance from the middle of the target), measured in mm. To measure errors, the LEMOCOT will be performed on an array of force sensors (Zebris FDM-T Treadmill, Zebris Medical GmbH, Germany) that detects the touches position. **Measure:** Coordination-LE2 **Time Frame:** Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** Response enhancement following a startling auditory stimuli (StartReact measure). Reaction time is measured in msec based on EMG signal from the wrist extensors and biceps (gtech USB-Amp). The StartReact measure is the enhancement in reaction time in the startle condition (LED+105Db auditory stimulus) compared to a control condition (LED+80Db auditory stimulus) **Measure:** Reticulospinal excitability **Time Frame:** one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** The ability to control a cursor in a virtual environment using EMG recordings from wrist extensors and biceps (Trigno Wireless EMG System, Delsys, USA). Outcome is success rate in %. **Measure:** Muscle controllability1 **Time Frame:** one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** The ability to control a cursor in a virtual environment using EMG recordings from wrist extensors and biceps (Trigno Wireless EMG System, Delsys, USA). Outcome is time to target sec. **Measure:** Muscle controllability2 **Time Frame:** one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** The ability to control a cursor in a virtual environment using EMG recordings from wrist extensors and biceps (Trigno Wireless EMG System, Delsys, USA). Outcome is path length in cm. **Measure:** Muscle controllability3 **Time Frame:** one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year **Description:** CT/MRI based structural neuroimaging. Outcomes are the areas affected by stroke. **Measure:** Neuroimaging **Time Frame:** one or more of :1-month, 3-month, 6-month, 1-year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * \>18 years of age * Independent in all activities of daily living before the stroke. * In- and out-patients at Adi-Negev Nahalat-Eran rehabilitation center, with first ever stroke, or with a recurrent stroke that did not lead to disability (were independent in ADL before the second stroke). * Medically stable * Able to provide informed consent. Exclusion Criteria: * The presence of any degenerative neurological condition, neuropathy, myopathy or Polio that are not secondary to stroke, excluding diabetic related changes. * Traumatic brain injury and/or extra-cerebral hemorrhage. * Significant psychiatric condition, including alcoholism and drug abuse. * Any severe orthopedic condition (such as amputation or severe pain that limits activity) or chronic pain syndrome. * Participation in another interventional study. **Healthy Volunteers:** True **Maximum Age:** 85 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Stroke survivors and healthy adults. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Simona Bar-Haim, PhD **Phone:** 972-54-470-2553 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Lior Smuelof, PhD **Role:** CONTACT #### Locations **Location 1:** **City:** Haifa **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** David Tanne, MD - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Firas Mawase, PhD - **Phone:** 972-54-782-3017 - **Role:** CONTACT ***Contact 3:*** - **Name:** Firas Mawase, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Israel **Facility:** Rambam/Technion **Status:** NOT_YET_RECRUITING **Location 2:** **City:** Ofakim **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Shilo Kramer, MD - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Simona Bar-Haim, PhD - **Role:** CONTACT ***Contact 3:*** - **Name:** Lior Smuelof, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Israel **Facility:** Adi-Negev Nahalat Eran **Status:** RECRUITING **Location 3:** **City:** Hebron **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Akram Amro, PhD - **Role:** CONTACT **Country:** Palestinian Territory, occupied **Facility:** Al-Ahli hospital **Status:** NOT_YET_RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Ben-Gurion University of the Negev **Name:** Simona Bar-Haim, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Ben-Gurion University of the Negev **Name:** Lior Smuelof, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** Ben-Gurion University of the Negev **Name:** Shirley Handelzalts, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 4:** **Affiliation:** Technion, Israel Institute of Technology **Name:** Firas Mawase, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 5:** **Affiliation:** Green Land Society for Health Development **Name:** Akram Amro, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** all IPD that underlie results in a publication **Info Types:** - STUDY_PROTOCOL - SAP - CSR - ANALYTIC_CODE **IPD Sharing:** YES ### References Module #### References **Citation:** Rosenstein, M. T., Collins, J. J., & De Luca, C. J. (1993). A practical method for calculating largest Lyapunov exponents from small data sets. Physica D: Nonlinear Phenomena, 65(1-2), 117-134. **Citation:** Platz T, Denzler P, Kaden B, Mauritz KH. Motor learning after recovery from hemiparesis. Neuropsychologia. 1994 Oct;32(10):1209-23. doi: 10.1016/0028-3932(94)90103-1. **PMID:** 7845561 **Citation:** Balasubramanian S, Melendez-Calderon A, Roby-Brami A, Burdet E. On the analysis of movement smoothness. J Neuroeng Rehabil. 2015 Dec 9;12:112. doi: 10.1186/s12984-015-0090-9. **PMID:** 26651329 **Citation:** Collins JJ, De Luca CJ. Open-loop and closed-loop control of posture: a random-walk analysis of center-of-pressure trajectories. Exp Brain Res. 1993;95(2):308-18. doi: 10.1007/BF00229788. **PMID:** 8224055 ## 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:** NCT06441539 **Brief Title:** Bingo Drug-eluting Balloon Versus a Drug-eluting Stent for Coronary Bifurcation Lesions **Official Title:** Bingo Drug-eluting Balloon Versus a Drug-eluting Stent for Coronary Bifurcation Lesions: a Prospective, Multi-center, Randomized, Non-inferiority Trial #### Organization Study ID Info **ID:** LNYY2024001 #### Organization **Class:** INDUSTRY **Full Name:** Yinyi(Liaoning) Biotech Co., Ltd. ### Status Module #### Completion Date **Date:** 2026-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-02-28 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Yinyi(Liaoning) Biotech 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:** Bingo drug-eluting balloon versus a drug-eluting stent for coronary bifurcation lesions: a prospective, multi-center, randomized, non-inferiority trial ### Conditions Module **Conditions:** - Coronary Artery Disease **Keywords:** - Coronary bifurcation - Percutaneous coronary intervention - Drug-coated balloon ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 218 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Treat the main vessel and side branch of bifurcation lesion with drug-eluting balloon **Intervention Names:** - Device: Bingo® Paclitaxel coated balloon **Label:** drug-eluting balloon **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Treat the main vessel of bifurcation lesion with drug-eluting stent, and treat the side branch with uncoated balloon or drug-eluting stent **Intervention Names:** - Device: Xience® Alpine Everolimus Eluting Coronary Stent System **Label:** drug-eluting stent **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - drug-eluting balloon **Description:** Treat the main vessel and side branch of bifurcation lesion with drug-eluting balloon **Name:** Bingo® Paclitaxel coated balloon **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - drug-eluting stent **Description:** Treat the main vessel of bifurcation lesion with drug-eluting stent, and treat the side branch with uncoated balloon or drug-eluting stent **Name:** Xience® Alpine Everolimus Eluting Coronary Stent System **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** use quantitative coronary angiography by an independent core laboratory **Measure:** in-segment late lumen loss in main branch **Time Frame:** 9 months #### Secondary Outcomes **Description:** include device success, lesion success and clinical success **Measure:** Procedure success rates **Time Frame:** up to 7 days in-hospital **Description:** use quantitative coronary angiography by an independent core laboratory **Measure:** Minimal lumen diameter **Time Frame:** 9 months **Description:** use quantitative coronary angiography by an independent core laboratory **Measure:** Diameter stenosis **Time Frame:** 9 months **Description:** use quantitative coronary angiography by an independent core laboratory **Measure:** Dissection and type **Time Frame:** 9 months **Description:** use quantitative coronary angiography by an independent core laboratory **Measure:** in-segment late lumen loss in side branch **Time Frame:** 9 months **Description:** use quantitative coronary angiography by an independent core laboratory **Measure:** Binary restenosis **Time Frame:** 9 months **Description:** include cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization **Measure:** Target lesion failure **Time Frame:** 1, 6, 9 and 12 months **Description:** include acute, sub-acute, late and very late period **Measure:** Target lesion thrombosis **Time Frame:** 1, 6, 9 and 12 months **Description:** type 2, 3 or 5 **Measure:** BARC bleeds **Time Frame:** 1, 6, 9 and 12 months **Description:** any stroke **Measure:** Stroke **Time Frame:** 1, 6, 9 and 12 months **Description:** include peri-operation and 12 months **Measure:** Myocardial infarction **Time Frame:** Peri-operation and 12 months **Description:** include cardiac and all-cause death **Measure:** Death **Time Frame:** 1, 6, 9 and 12 months **Description:** composite endpoint with death, myocardial infarction and target vessel revascularization **Measure:** Major Adverse Cardiovascular Events **Time Frame:** 1, 6, 9 and 12 months ### Eligibility Module **Eligibility Criteria:** Clinical Inclusion Criteria: 1. Age 18 to 80 2. Patients with chronic stable coronary artery disease, or unstable angina, or NSTEMI (Grace score\<140), or STEMI more than one week 3. Subjects suitable for PCI 4. Subjects understand the trial purpose, volunteer to participate and sign informed consent form Angiographic Inclusion Criteria (by visual): 1. One coronary de novo bifurcation lesion (including Medina classification: 1,1,1 / 1,0,1 / 0,1,1, which need to be treated for both main and side branches) 2. The reference vessel diameter of main branch is between 2.5 to 4.0 mm, length ≤ 30 mm. Before lesion preparation, lesion diameter stenosis shall be ≥70%, or ≥50% with evidence of myocardial ischemia 3. The reference vessel diameter of side branch is ≥2.0 mm, length \<20 mm. Before lesion preparation, lesion diameter stenosis shall be ≥70% 4. No more than 3 lesions on the non-target vessel in the same operation, and shall be successfully treated before the target vessel 5. No more than 1 non-target lesion on the target vessel in the same operation, and shall be successfully prepared before the target lesion (successful preparation of non-target lesion is defined as residual stenosis ≤30% and TIMI flow 3). After randomization, the non-target lesion shall be treated according to the assigned group, for the experimental group, using the experimental DCB is recommended; for the control group, using DES is recommended; Independent lesion on the same coronary artery is defined as interval \>5 mm 6. The target lesions of main and side branches must be successfully prepared (successful preparation is defined as: residual stenosis ≤30% , without NHLBI type C or above dissection, and TIMI flow 3) Clinical Exclusion Criteria: 1. Severe heart failure (NYHA IV), cardiogenic shock or severe valvular heart disease 2. Left ventricular ejection fraction ≤35% 3. Severe renal insufficiency (eGFR \<30 ml/min) 4. Severe liver insufficiency (glutamate transaminase (ALT) or glutamate transaminase (AST) \>3 times the upper limit of normal) 5. Pregnant women or planned pregnancy 6. With a known allergy to heparin, contrast agent, paclitaxel and everolimus 7. Unable to receive antiplatelet agents and anticoagulants, bleeding tendency or coagulopathy 8. Life expectancy does not exceed 1 year 9. Participating in other drug or device clinical trials without reaching the primary endpoint 10. Subjects who had undergone coronary revascularization in the last 6 months 11. Subjects not eligible by the investigator for other reasons Angiographic Exclusion Criteria (by visual): 1. In-stent restenosis lesion 2. Left main bifurcation lesion 3. Chronic total occlusive lesion 4. Target vessel is severely distorted, angulated or calcified, which is anticipated difficult to cross for balloon or stent 5. Target lesion remains significant residual thrombus after preparation **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003327 - Term: Coronary Disease - ID: D000017202 - Term: Myocardial Ischemia - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000001161 - Term: Arteriosclerosis - ID: D000001157 - Term: Arterial Occlusive Diseases - ID: D000014652 - Term: Vascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M6546 - Name: Coronary Artery Disease - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown - ID: M6549 - Name: Coronary Disease - Relevance: LOW - As Found: Unknown - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M4469 - Name: Arteriosclerosis - Relevance: LOW - As Found: Unknown - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003324 - Term: Coronary Artery Disease ### 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: D000091203 - Term: MTOR Inhibitors - ID: D000047428 - Term: Protein Kinase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M19537 - Name: Paclitaxel - Relevance: HIGH - As Found: Surgery - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M255 - Name: Everolimus - Relevance: HIGH - As Found: Criteria - ID: M26197 - Name: Tubulin Modulators - Relevance: LOW - As Found: Unknown - ID: M26196 - Name: Antimitotic Agents - Relevance: LOW - As Found: Unknown - ID: M21960 - Name: Sirolimus - Relevance: LOW - As Found: Unknown - ID: M353695 - Name: Temsirolimus - Relevance: LOW - As Found: Unknown - ID: M2827 - Name: MTOR Inhibitors - Relevance: LOW - As Found: Unknown - ID: M25820 - Name: Protein Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000017239 - Term: Paclitaxel - ID: D000068338 - Term: Everolimus ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441526 **Acronym:** PISA-II **Brief Title:** Surgical Closure vs Anti-TNF in the Treatment of Perianal Fistulas in Crohn's Disease (PISA-II): a Comprehensive Cohort Design **Official Title:** Surgical Closure Versus Anti-TNF in the Treatment of Perianal Fistulas in Crohn's Disease (PISA-II): a Comprehensive Cohort Design #### Organization Study ID Info **ID:** NL66176.018.18 #### Organization **Class:** OTHER **Full Name:** Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) ### Status Module #### Completion Date **Date:** 2021-06-07 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-01 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-12-07 **Type:** ACTUAL #### Start Date **Date:** 2013-09-14 **Type:** ACTUAL **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2019-04-10 **Study First Submit QC Date:** 2024-06-01 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) #### Responsible Party **Investigator Affiliation:** Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) **Investigator Full Name:** Willem A. Bemelman **Investigator Title:** Principal investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** Currently, the treatment of Crohn's patients with perianal fistulas predominantly exists of anti-TNF medication. However, its efficiency has never been directly compared to surgical closure of the perianal fistula. The aim of this study is to compare radiological fistula healing at MRI after 18 months follow-up in Crohn's patients undergoing surgical closure to anti-TNF medication as treatment of perianal Crohn's fistulas. Study design: In this multicenter comprehensive cohort design (CCD) Crohn's patients with a (re)active high perianal fistula will be allocated to anti-TNF for 1 year or surgical closure after 2 months under a short course of anti-TNF. Patients with a distinct preference will be treated accordingly, whereas only indifferent patients will be randomised in the usual way. Main study parameters/endpoints: The primary outcome parameter is the number of patients with radiologically closed fistulas based on an evaluated MRI-score after 18 months. Secondary outcomes are clinical closure, number of patients undergoing surgical re-interventions and number of re-interventions, recurrences and quality of life based on the Perianal Disease Activity Index (PDAI). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All patients will receive one of the two standard treatment approaches that are currently used for Crohn's fistulas. All effort has been performed to ensure most optimal treatment, according to best available evidence and current guidelines. Since there is no experimental study-arm, there are no additional risks associated with participation. During the study, the medical staff and trial nurses will monitor the necessity of surgical interventions and hospitalizations. At baseline and after 18 months all patients will undergo a MRI to score the fistula. Secondary outcome parameters will be assessed during visits to the outpatient clinic or telephone consultations at baseline and at intervals of 3 months for the duration of the study period. Every 6 months patients were asked to fill out the PDAI questionnaire with their physician. Based on the available literature, radiological closure of fistulas is expected in 40% of patients in the surgical closure group compared to 15% in the anti-TNF group. The increase in closure rate from 15% to 40% is considered clinically relevant. Due to the combination of a preference and randomized cohort, the appropriate sample size to detect this 25% difference is flexible and is adjusted for a skewed distribution. The minimal sample size, in case of a 1:1 treatment allocation, needed to detect this difference with a Chi-square test equals 86 patients (alpha 0.05, power 80%). The maximal allowed skewed distribution is set at 1:4, which will result in a maximal sample size of 116 patients. ### Conditions Module **Conditions:** - Perianal Fistula - Crohn Disease **Keywords:** - Crohn's disease - Perianal fistula - Anti-TNF - Advancement plasty - LIFT-procedure - Fistula closure - Comprehensive cohort design ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This is an international, multicentre, prospective, comprehensive cohort design trial to identify the most optimal treatment of Crohn's high perianal fistulas. In a comprehensive cohort design patients with a preference will be treated accordingly, whereas only those indifferent to treatment will be randomised in the usual way (combined randomised and preference cohort). ##### Masking Info **Masking:** SINGLE **Masking Description:** The primary outcome is fistula closure based on MRI (completely fibrotic fistula tract). A radiologist blinded to treatment allocation will score fibrosis and inflammation of the tract based on MRI. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 94 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Seton placement, followed by anti-TNF medication (infliximab or adalimumab) in combination with a immunomodulator after ± 2 weeks. The seton will be removed after ± 6 weeks. Continuation of anti-TNF medication for at least 1 year, after one year continuation is at the discretion of treating physician. **Intervention Names:** - Drug: anti-tumour necrosis factor α antibodies **Label:** Anti-TNF **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Seton placement, followed by anti-TNF medication in combination with a immunomodulator after ± 2 weeks. After 8-10 weeks removal of seton and surgical closure (advancement plasty or ligation of the intersphincteric tract (LIFT) procedure). Anti-TNF in combination with a immunomodulator will be stopped after ± 4 months. **Intervention Names:** - Procedure: Advancement plasty **Label:** Surgical closure **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Anti-TNF **Description:** Biological drug **Name:** anti-tumour necrosis factor α antibodies **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Surgical closure **Description:** Surgical closure of the internal opening **Name:** Advancement plasty **Other Names:** - Ligation of the intersphincteric tract (LIFT) **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The number of patients with radiologically closed (completely fibrotic) fistula tract on MRI **Measure:** Fistula closure **Time Frame:** at 1,5 year #### Secondary Outcomes **Description:** The number of patients with clinical closure, defined as closure of the external opening without discharge of pus or faeces on palpation **Measure:** Clinical closure **Time Frame:** at 1,5 year **Description:** Amount of patients undergoing surgical re-intervention **Measure:** The number of patients undergoing surgical re-intervention **Time Frame:** at 1,5 year **Description:** Amount of re-interventions **Measure:** The number of re-intervention **Time Frame:** at 1,5 year **Description:** measured by the Perianal Disease Activity Index (PDAI score) **Measure:** The quality of life of a patient **Time Frame:** Every six months from baseline till 18 months **Description:** Amount of patients with a recurrence, defined as re-opening of the external opening after clinical closure **Measure:** The number of recurrences **Time Frame:** at 1,5 year ### Eligibility Module **Eligibility Criteria:** Inclusion criteria * ≥ 18 years * (re-)active perianal fistula * High perianal fistula tract (intersphincteric, transsphincteric, suprasphincteric) located in the upper two-thirds of the external sphincter or puborectal muscle * Fistula with one internal opening (based on MRI imaging). The number of external fistulas does not have to be taken into account * Written informed consent 4.3 Exclusion criteria * Proctitis (defined as any active mucosal inflammation or ulcer \> 5mm in the rectum) * Anorectal stenosis (defined as the impossibility to introduce a proctoscope) * Submucosal fistulas \& low intersphincteric fistulas (lower one-third of external sphincter) * Rectovaginal fistula * Multiple internal openings * Use of Anti-TNF medication for more than 3 months * Previous failure of Anti-TNF treatment for perianal fistula * Patients with a stoma * Dementia or altered mental status that would prohibit the understanding and giving of informed consent **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Amsterdam-Zuidoost **Country:** Netherlands **Facility:** Amsterdam UMC **State:** Noord Holland **Zip:** 1105AZ #### Overall Officials **Official 1:** **Affiliation:** Amsterdam UMC, location AMC **Name:** Willem Bemelman, MD PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES ## 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 - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000007412 - Term: Intestinal Fistula - ID: D000016154 - Term: Digestive System Fistula - ID: D000012002 - Term: Rectal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M6638 - Name: Crohn Disease - Relevance: HIGH - As Found: Crohn's Disease - ID: M8532 - Name: Fistula - Relevance: HIGH - As Found: Fistula - ID: M14845 - Name: Rectal Fistula - Relevance: HIGH - As Found: Perianal Fistula - 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 - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M10446 - Name: Intestinal Fistula - Relevance: LOW - As Found: Unknown - ID: M18616 - Name: Digestive System Fistula - Relevance: LOW - As Found: Unknown - ID: M14844 - Name: Rectal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003424 - Term: Crohn Disease - ID: D000012003 - Term: Rectal Fistula - ID: D000005402 - Term: Fistula ### Intervention Browse Module - Ancestors - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: HIGH - As Found: Given - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M326 - Name: Adalimumab - Relevance: LOW - As Found: Unknown - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: M375 - Name: Infliximab - Relevance: LOW - As Found: Unknown - ID: M3628 - Name: Adjuvants, Immunologic - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000906 - Term: Antibodies ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441513 **Brief Title:** The Preventive Effect of Chemotherapy-induced Hand-foot Syndrome **Official Title:** The Preventive Effect of Chinese Traditional Medicine Nursing Combined With Case Tracking Management on Chemotherapy-induced Hand-foot Syndrome: a Randomized Controlled Study #### Organization Study ID Info **ID:** LM2023104 #### Organization **Class:** OTHER **Full Name:** Peking University Third Hospital ### Status Module #### Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2021-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Peking University Third Hospital #### Responsible Party **Investigator Affiliation:** Peking University Third Hospital **Investigator Full Name:** Chen Yamei **Investigator Title:** Head nurse **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** this study will use traditional Chinese medicine bath with no obvious side effects combined with case tracking management mode to form nursing measures to prevent hand foot syndrome. A randomized controlled trial design will be used to collect cases of hand foot syndrome (HFS) that did not appear after chemotherapy in the ward of the Department of chemotherapy, Peking University Third Hospital, and carry out nursing intervention. **Detailed Description:** Chemotherapy drugs have achieved certain satisfactory clinical efficacy in the treatment of cancer, but they can also cause common side effects including digestive tract reactions, skin rashes, hand-foot syndrome, and bone marrow suppression. Among them, hand-foot syndrome (HFS) is a common chemotherapy complication with an incidence rate of up to 50%-60%6. About 17%-24% of patients may develop grade 3 HFS. The main clinical manifestation of HFS is characterized by red plaques and sensory abnormalities on the palms and soles of the hands and feet. The initial symptoms are hyperemia and erythema on the palms and soles, tingling sensation, sensory abnormalities/sensory insensitivity, numbness at the ends of the fingers/toes, followed by tension, pain, dryness, skin desquamation and peeling (small or large flakes of skin lifted) on the hands and feet. In severe cases, blisters, exudation, and even ulcers may occur, accompanied by severe pain. Patients may be unable to walk or hold objects due to pain, and even lose their ability to take care of themselves. Currently, HFS is mainly treated by interrupting chemotherapy, symptomatic analgesia, anti-inflammation, and preventing infection. The occurrence of HFS brings great inconvenience to patients' daily lives, not only affecting their ability to live independently (including general labor and work), but also adding additional economic expenses. More importantly, due to the impact of drug reduction or withdrawal, cancer treatment cannot be carried out smoothly, which has a negative impact on patients' quality of life. Therefore, paying attention to the prevention of hand-foot syndrome is of great clinical significance. At present, domestic and foreign scholars have adopted oral administration of vitamin, mecobalamin and other neuroprotective drugs to prevent HFS， but the incidence of HFS remains high. The analysis of the reasons found that due to the lack of effective management, patients have poor compliance, and patients are worried about the side effects of drugs, which further reduces their compliance. Many domestic studies have found that external treatment of traditional Chinese medicine (including bathing and application) is safe, effective and easy to implement. Moreover, more and more studies have found that traditional Chinese medicine can effectively treat hand-foot syndrome Case tracking management mode is a branch of tracking methodology, which refers to tracking the diagnosis, treatment and nursing process experienced by patients in the whole medical system, evaluating the nursing service of the hospital from the perspective of "patients", so that the evaluator can "see" the whole nursing process from the perspective of patients. In recent years, studies have found that the case tracking management model can quickly find and improve the quality of clinical nursing problems, and has a significant role in promoting high-quality nursing and nursing safety. Therefore, this study will use traditional Chinese medicine bath with no obvious side effects combined with case tracking management mode to form nursing measures to prevent hand foot syndrome. A randomized controlled trial design will be used to collect cases of hand foot syndrome (HFS) that did not appear after chemotherapy in the ward of the Department of chemotherapy, Peking University Third Hospital, and carry out nursing intervention. ### Conditions Module **Conditions:** - Cancer **Keywords:** - Hand foot syndrome - Case Tracking management - TCM External Treatment Nursing ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The process of randomization and concealment allocation was conducted by a research team who were not involved in the study. Spss26.0 software was used to program and generate a random number table, which was randomly divided into two groups. ##### Masking Info **Masking:** SINGLE **Masking Description:** Random numbers were sequentially sealed in a continuously numbered and opaque envelope. The envelopes were opened sequentially to allocate participants to the case tracking management or control group by the other researcher. Because of the nature of continuing care intervention, it was not possible to blind the participants about the intervention. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 130 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** On the basis of the intervention measures in the control group, we added the following measures. First, we set up a team for the prevention of hand foot syndrome, including 1 head nurse of the tumor chemotherapy department, 2 doctors, 16 nurses (16 nurses were divided into 4 groups, each group designated a team leader) and the researchers of this experiment. Doctors are responsible for the diagnosis of HFS and the determination of traditional Chinese medicine prescriptions, head nurses and team leaders are responsible for quality control, and nurses are responsible for the assessment, intervention and evaluation of patients. **Intervention Names:** - Other: Chinese traditional medicine nursing combined with case tracking management **Label:** Invention group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** We distributed traditional Chinese medicine to the control group and carried out health education, which mainly included elaborating the symptoms, mechanism and corresponding treatment measures of HFS for patients, reducing the fear of patients, helping them relax and adjust their mentality, and cooperating with observation. At the same time, we should also try to reduce the chance of skin damage on hands / feet, such as wearing long clothes and pants when going out to avoid direct sunlight; Wear loose shoes, socks and gloves to avoid frequent friction and excessive pressure of hands and feet; Avoid heavy physical labor and intense exercise; Avoid contact with supercooled, overheated, sharp and irritating objects. **Intervention Names:** - Other: Health Education **Label:** Control group **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Invention group **Description:** First, we set up a team for the prevention of hand foot syndrome, including 1 head nurse of the tumor chemotherapy department, 2 doctors, 16 nurses (16 nurses were divided into 4 groups, each group designated a team leader) and the researchers of this experiment. Doctors are responsible for the diagnosis of HFS and the determination of traditional Chinese medicine prescriptions, head nurses and team leaders are responsible for quality control, and nurses are responsible for the assessment, intervention and evaluation of patients. **Name:** Chinese traditional medicine nursing combined with case tracking management **Other Names:** - Health Education **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Control group **Description:** elaborating the symptoms, mechanism and corresponding treatment measures of HFS for patients, reducing the fear of patients, helping them relax and adjust their mentality, and cooperating with observation. **Name:** Health Education **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Number of HFS patients / total number of patients included in each group **Measure:** Incidence of HFS **Time Frame:** At the end of 42 days of chemotherapy for the patient #### Secondary Outcomes **Description:** QoL was measured by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire （EORTC-QOL-C30） **Measure:** EORTC-QOL-C30 **Time Frame:** At the end of 42 days of chemotherapy for the patient ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * (1) no HFS symptoms in chemotherapy patients; (2) Ages 18 to 65 years; (3) Estimated survival ≥ 3 months; (4) There was no dysfunction of major organs, heart, liver and kidney functions were basically normal, and the laboratory indicators met the following requirements: neutrophils \> 1.5 × 109/l, platelets \> 100 × 109/l, hemoglobin \> 90g/l; Bilirubin was normal or \< 1.5 × ULN; AST and alt \< 2.5 × ULN; Serum creatinine \< 1.5 × ULN; Endogenous creatinine clearance (CCR) ≥ 60ml/min. (5) Those who can understand the situation of this study, can cooperate in the assessment of HFS grading, and have signed the informed consent. Exclusion Criteria: * (1) history of nerve trauma before chemotherapy, diabetic neuropathy, spinal cord compression syndrome without surgical treatment, spinal canal stenosis or spinal cord nerve root compression, and central nervous system tumors; (2) Patients with skin lesions of hands and feet; (3) Those who have plans to use other drugs that may affect HFS (including urea cream, vitamin B6, celecoxib, compound Sophora flavescens injection, calf blood deproteinized extract intravenous injection); (4) Patients with severe, uncontrolled organic lesions or infections, such as decompensated heart, lung, renal failure, etc., that lead to intolerance to chemotherapy; (5) Those who participate in other clinical trials at present or within 4 weeks; (6) Obvious neurological and psychiatric history, including dementia or epilepsy that may affect understanding and informed consent; (7) Intolerant or allergic to the traditional Chinese medicine prescriptions in this study. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yamei Chen **Phone:** 13910003135 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Jing Wang **Phone:** 13699176380 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yamei Chen - **Phone:** 13910003135 - **Role:** CONTACT **Country:** China **Facility:** Peking University Third Hospital **State:** Beijing **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Peking University Third Hospital Library **Name:** Yamei Chen **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Description:** The data that support the findings of this study are available on reasonable request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions. **IPD Sharing:** NO ### References Module #### References **Citation:** Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. **PMID:** 33538338 **Citation:** Miller KK, Gorcey L, McLellan BN. Chemotherapy-induced hand-foot syndrome and nail changes: a review of clinical presentation, etiology, pathogenesis, and management. J Am Acad Dermatol. 2014 Oct;71(4):787-94. doi: 10.1016/j.jaad.2014.03.019. Epub 2014 May 1. **PMID:** 24795111 **Citation:** Kanbayashi Y, Taguchi T, Ishikawa T, Otsuji E, Takayama K. Risk Factors of Capecitabine-Induced Hand-Foot Syndrome: A Single-Institution, Retrospective Study. Oncology. 2023;101(7):407-414. doi: 10.1159/000529851. Epub 2023 Apr 19. **PMID:** 37075722 **Citation:** Kao YS, Lo CH, Tu YK, Hung CH. Pharmacological prevention strategy for capecitabine-induced hand-foot syndrome: A network meta-analysis of randomized control trials. Dermatol Ther. 2022 Oct;35(10):e15774. doi: 10.1111/dth.15774. Epub 2022 Aug 30. **PMID:** 36054263 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003875 - Term: Drug Eruptions - ID: D000003872 - Term: Dermatitis - ID: D000012871 - Term: Skin Diseases - ID: D000004342 - Term: Drug Hypersensitivity - ID: D000064420 - Term: Drug-Related Side Effects and Adverse Reactions - ID: D000064419 - Term: Chemically-Induced Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC25 - Name: Substance Related Disorders - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M29710 - Name: Hand-Foot Syndrome - Relevance: HIGH - As Found: Hand-foot Syndrome - ID: M8219 - Name: Exanthema - Relevance: LOW - As Found: Unknown - ID: M7070 - Name: Drug Eruptions - Relevance: LOW - As Found: Unknown - ID: M7067 - Name: Dermatitis - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M7517 - Name: Drug Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M30303 - Name: Drug-Related Side Effects and Adverse Reactions - Relevance: LOW - As Found: Unknown - ID: M30302 - Name: Chemically-Induced Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000060831 - Term: Hand-Foot Syndrome ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441500 **Acronym:** Smilebright **Brief Title:** Oral Health and Dental Caries Prevention Intervention for Children in Romania **Official Title:** Child Oral Health Pilot Programme - SmilebrightRO #### Organization Study ID Info **ID:** 18688/16.10.2023 #### Organization **Class:** OTHER **Full Name:** University of Medicine and Pharmacy "Victor Babes" Timisoara ### Status Module #### Completion Date **Date:** 2025-12-21 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-11-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-07 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-04-19 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Carol Davila University of Medicine and Pharmacy **Class:** OTHER **Name:** Grigore T. Popa University of Medicine and Pharmacy **Class:** OTHER **Name:** Iuliu Hatieganu University of Medicine and Pharmacy **Class:** OTHER **Name:** George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures **Class:** OTHER **Name:** University of Medicine and Pharmacy Craiova #### Lead Sponsor **Class:** OTHER **Name:** University of Medicine and Pharmacy "Victor Babes" Timisoara #### Responsible Party **Investigator Affiliation:** University of Medicine and Pharmacy "Victor Babes" Timisoara **Investigator Full Name:** Basaraba Gabriela Lavinia **Investigator Title:** Head of grant department **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** During 2019-2020, the National Oral Health Survey evaluated a significant sample of children aged 5, 6 and 12 years, gathering baseline data on oral health. Data was used to estimate the distribution and severity of dental caries, the need for community-oriented disease prevention and health promotion, and the nature of oral health intervention(s) required. The survey also established how younger age groups can be reached and evaluated. Only 14% of 6 years old children have dmft 0 and the SiC index of the same sample is 9.83. High prevalence of tooth decay with high severity scores, significant inequalities in oral health and poor use and access to services showed the need for a child oral health programme. The originality of the project lies in the vision of using fluoridated toothpaste not only as a means of preventing new carious lesions but also in the therapeutic effect of fluoridated toothpaste, which the study set out to evaluate. This programme could represent an example of good practice for the countries in our region, starting from downstream oral health interventions, such as clinical prevention and oral health promotion, and developing towards upstream interventions. The aim of the project is to improve oral health and reduce inequalities both in dental health and access to dental services by shifting the balance of care towards preventive care. The programme is structured on three levels: 1. Specific training for dental hygienists to deliver oral health promotion to children and nursery educators, focus on tailoring key messages outlined in the care pathway and practical preparation for delivering interventions in nurseries. 2. A toothpaste/toothbrushing scheme involving free daily toothbrushing to every 3 and 4-year old child attending nursery. 3. Provision of clinical prevention activities delivered by dental hygienists for children attending nurseries. The evaluation of the programme consolidates and builds upon previous evaluation work of the National Oral Health Survey for children. Due to the fact that it is a pilot programme aiming to be further implemented at national level, an evolving model of evaluation is appropriate. This allows the evaluation to be responsive to issues emerging from its implementation and develops the programme as a result of the evaluation findings. **Detailed Description:** Until recently, Romania has lacked baseline data regarding the oral health status of children. A previous study by Petersen et al. was conducted in the 1990s covering only five major cities and without taking into account rural areas. Some local papers described a high caries prevalence. Only one longitudinal study assesses caries trends in Romanian schoolchildren. A contemporary assessment was therefore mandatory in order to advance scientific understanding and allow for the development of adequate public health policies. During 2019-2020, the National Oral Health Survey financed by The Borrow Foundation, evaluated a significant sample of children aged 5, 6 and 12 years, gathering baseline data on oral health according to the WHO guidelines. The data was used to estimate the distribution and severity of dental caries, the need for community-oriented disease prevention and health promotion, and the nature and urgency of the oral health intervention(s) required. The survey also established how younger age groups can be reached and evaluated. Unpublished data show that only 14% of 6 years old children have dmft 0 and the SiC index of the same sample is 9.83. High prevalence of tooth decay with high severity scores, significant inequalities in oral health and poor use and access to services showed the need for a child oral health programme. The main objectives of the program are to: 1. Reorient the traditional curative approach, which is basically pathogenic, and move towards a preventive promotional approach 2. Strengthen cross-sectoral collaboration across key settings, such as schools, communities and workplaces to promote habits and healthy lifestyles, integrating teachers and the family; 3. Raising the priority accorded to the prevention and control of oral diseases in regional and national agendas and development goals, through strengthened cooperation and advocacy. The programme is designed to deliver additional clinical prevention activities through dental hygienists, aimed at children aged three years and above attending priority nursery establishments in order to improve oral health of young children, and complemented the established national toothpaste/toothbrushing scheme. The programme will be implemented for a period of 24 months, under guidance from the WHO Collaborative Centre for Epidemiology and Community Dentistry Milan, Italy. Consent from the national and regional authorities will be obtained, nurseries will be informed and the informed consent of the parents will be asked. The total sample size will be calculated according to the WHO guidelines using a stratified sampling technique for examination sites in Bucharest, Timisoara, Cluj-Napoca, Craiova, Iasi, Targu Mures and the surrounding geographical area. The programme will be conducted in collaboration with the Universities of Medicine in the capital and the cities mentioned above, under supervision of the university staff. Data collection points will be 4 kindergartens in the Capital or metropolitan areas, 2 kindergartens in each of 2 large cities, and 1 kindergarten in each 4 villages from different geographic areas. The programme fits in the Oral Health Resolution of the Seventy-fourth World Health Assembly (WHA 74.5 - 31.05.2021) aiming at: * understanding and addressing the key risk factors for poor oral health and associated burden of disease; * fostering the integration of oral health within their national policies, including through the promotion of articulated interministerial and intersectoral work; * reorienting the traditional curative approach, which is basically pathogenic, and move towards a preventive promotional approach with risk identification for timely, comprehensive and inclusive care; * strengthen cross-sectoral collaboration across key settings, such as schools, communities and workplaces to promote habits and healthy lifestyles, integrating teachers and the family; The study design takes into consideration all principles stated in the WHO Implementation Manual "Ending childhood caries": Early diagnosis of caries lesions through clinical examinations in the nurseries, control of risk factors trough the evaluation of oral health related knowledge and behaviours and health education, arresting caries through the application of fluoride varnishes, developing primary care teams by introducing a new workforce - dental hygienists, building a framework to integrate prevention and control of dental caries into general health interventions. The project will be implemented in collaboration with the universities of Medicine and Pharmacy in the country to ensure a homogeneous distribution of evaluation sites. Selection of nurseries will be done according to the pathfinder sampling technique. This survey design is suitable for collection of data for planning purposes and monitoring of oral health programmes in all countries regardless of the level of disease, availability of resources or complexity of care. The principles of the sampling techniques are the following: * The study supposes a sample of 460 children; * There are 6 universities involved in data collection; * Data will be collected from 3 types of residential areas: metropolitan areas (180 evaluations); big cities (180 evaluations), rural areas (100 evaluations); * In metropolitan areas and big cities, 25 children have to be evaluated in the same kindergarten. * In rural areas, more than one kindergarten can be evaluated until the desired number of evaluations is obtained for the specific region. This principle has been added because kindergarten is not mandatory in Romania and the number of children enrolled in kindergarten in rural areas is quite low in some regions of the country. Distribution of data collection points: * University of Medicine and Pharmacy Bucharest will provide: * 25 evaluations in one kindergarten in Bucharest; * 25 evaluations in rural areas of surrounding counties * University of Medicine and Pharmacy Cluj will provide: * 25 evaluations in one kindergarten in Cluj Napoca; * 25 evaluations in rural areas of surrounding counties; * University of Medicine and Pharmacy Craiova will provide: * 25 evaluations in 2 kindergartens in Drobeta-Turnu Severin; * 25 in rural areas of surrounding counties; * University of Medicine and Pharmacy Iași will provide: * 25 evaluations in 2 kindergartens in Iași (2 X 25 = 50); * 25 in rural areas of surrounding counties; * University of Medicine and Pharmacy Targu Mures will provide: * 25 evaluations in one kindergarten in Targu Mures; * 25 evaluations Miercurea Ciuc; * University of Medicine and Pharmacy Timișoara will provide: * 25 evaluations in one kindergarten in Timișoara; * 25 evaluations in 2 kindergartens in Arad; According to the WHO STEPS approach, results from the first two steps - self-evaluation and collection of clinical data will be used to plan and evaluate further health interventions. Volunteer dental hygienists students will be trained deliver oral health promotion to nursery educators and oral health promotion activities for children, focusing on tailoring of key messages to the specific age and on practical preparation for delivering interventions in the nurseries along with implementing the toothpaste/tooth brushing scheme involving free daily tooth brushing to every 3 and 4-year old child attending nursery. The evaluation of the programme consolidates and builds upon previous evaluation work of the National Oral Health Survey for children. Due to the fact that it is a pilot programme aiming to be further implemented at national level, an evolving model of evaluation is appropriate. This allows the evaluation to be responsive to issues emerging from its implementation and develops the programme as a result of the evaluation findings. Methods used in the evaluation have to be formative - to adapt the programme, and summative - to assess its impact. Evaluation activity includes the collection of routine monitoring data linked with national data sets from the previous survey, assessment of the programme's impact at different time-intervals, and assessment of economical outcomes. One of the outcomes will be to assess oral health practices of children using the previously designed questionnaire from the National Oral Health Survey, meaning to describe oral health behaviour of the evaluated children in correlation to the 'County Development Index', residential area, type of residence, characteristics of the parents (education, working status) and characteristics of the child (age, gender). The County Developmental Index is a sociological index that combines county-level variables: education stock, life expectancy at birth, medium age of adult population, average living space, number of private cars to 1000 inhabitants, and average household gas consumption. Another secondary outcome will establish correlations between the levels of oral health knowledge and clinically detected oral health status and assess the impact of the intervention on the oral and general health status. Monitoring the quality of the intervention delivered by dental hygienist students will assure the necessary information to change/adapt their education to the necessary actions. Short term outcomes will be: * Increased level of knowledge and improved oral health behaviours for children in this age group * Reduced risk of new carious lesions and progression of existing lesions * Improved skills of a new profession - dental hygienists and shift of workforce * Improvement of the existing data base and implementation of a monitoring activity at national level Other potential outcomes: * Improved knowledge and behaviour within the families which might lead to an improvement of oral but also general health status * Reduced inequalities in oral health care * Reduced treatment needs and therefore reduced costs for dental treatment The research team proposed to incorporate sustainability into the process taking into account the fact that health interventions often include a number of unquantifiable variables, which add a layer of complexity in terms of environmental appraisals. The discrepancy between the existence of evidence-based health promotion interventions and their use in practice is present in almost all medical fields, but has been widely recognized as a challenge in dentistry. Clearly, the traditional modes of spreading information through scientific publication channels and passive instruction are not sufficient to reliably initiate and sustain new practices. In order to move evidence-based approaches into practice, more careful examinations of methods to introduce and sustain effective oral health practices are needed. For this project we suggested a framework multi-staged approach. This resource is designed to interweave with the many other point of the project that have been developed to guide oral health professionals and dental organizations. ### Conditions Module **Conditions:** - Dental Caries - Early Childhood Caries - Quality of Life **Keywords:** - dental caries - quality of life - diet - socio-economic status - county development index ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Children aged 3-5 years, enrolled in kindergartens. The pathfinder sampling technique has been used to obtain a representative sample. As suggested by the WHO, this survey design is suitable for collection of data for planning purposes and monitoring of oral health programmes in all countries regardless of the level of disease, availability of resources or complexity of care. Clinical examinations will be performed using ICDAS criteria by calibrated medical staff from each partner university. Caries incidence rate will be calculated on each tooth as the unit of analysis and evaluated using a multi-step approach: net increment for caries severity using ICDAS calculated at each follow-up examinations; Events defined as a new lesion or as the sum of the Δ-caries changes of status recorded at the baseline, at interim, and at the last examination. The number of events will be appraised by subtracting the number of caries-free teeth at last examination from those at baseline. **Intervention Names:** - Other: Daily tooth brushing programme **Label:** Kindergarten children **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Kindergarten children **Description:** Implementing the toothpaste/toothbrushing scheme involving free daily toothbrushing to every 3 - 5-year old child attending nursery. Free distribution of toothpaste/toothbrush packs to every child every 3 months. Collection of routine monitoring data linked with national data sets from the previous survey regarding caries prevalence and risk factors.2.Monitor caries activity - net caries increment for initial, moderate, and extensive caries severity. **Name:** Daily tooth brushing programme **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Prevalence will be determined for the specific age group after primary examination using ICDAS criteria after calibration. Children will be examined in a seated position, using a dental mirror and a probe, without air-drying. Thus, ICDAS codes 1 and 2 will be counted together as "A". To evaluate the outcomes, a statistical analysis will be performed. All the data will be input into a spreadsheet (Microsoft Excel 2021 for Mac, version 16.4.8).The total number of existing caries will serve for the calculation of the dmft index (decayed-missing-filled teeth index) and the SiC index (Significant caries index). **Measure:** Epidemiologic baseline data on caries prevalence **Time Frame:** 3 months **Description:** Clinical examinations will be performed using ICDAS criteria by calibrated medical staff from each partner university after calibration. Children will be examined in a seated position, using a dental mirror and a probe, without air-drying. Thus, ICDAS codes 1 and 2 will be counted together as "A". Statistical analysis will be performed after inputing the data into a sheet (Microsoft Excel 2021 for Mac, version 16.4.8). Severity will be determined for the specific age group after primary examination using ICDAS criteria. ICDAS codes of 0 represent sound teeth, codes of 1 and 2 represent initial reversible caries lesions, only affecting the enamel, codes of 3 represent initial microcavitation of the enamel, codes of 4 represent moderate carious lesions and codes of 5 and 6 represent extended lesions. **Measure:** Epidemiologic baseline data on caries severity **Time Frame:** 3 months **Description:** Self-assessment of oral health behaviours of children will be done using the previously designed questionnaire from the National Oral Health Survey. The working tool consists of 15 items that make up the two types of behaviour (prevention and diet), and family characteristics (parent's level of education, working status). Behaviours will be correlated with clinical indices that will help us to delimit the existence or lack of certain significant differences among children. For a better understanding of the risk factors the evaluation relates to specific elements of the child (gender, age, parental education, residence), and elements related to the objective living conditions (county development index, residence, etc.). Statistical analysis using Poisson regression will correlate data obtained from self assessment with clinical outcomes expressed by the dmft index. **Measure:** Epidemiologic baseline self assessment data **Time Frame:** 3 months **Description:** Follow-up data regarding changes in caries status: new lesions appearing or existing caries status changes at interim and last examination. Caries incidence rate will be calculated on each tooth as the unit of analysis and evaluated using a multi-step approach: A - The net caries increment for initial, moderate, and extensive caries severity using ICDAS (Δ-initial, Δ- moderate, and Δ- extensive) will be calculated at each follow-up examinations; B - Events will be defined as a tooth getting a lesion or as the sum of the Δ-caries changes of status recorded at the baseline examination, at interim, and at the last examination. The number of events will be appraised by subtracting the number of caries-free teeth at last examination from those at baseline. The non-parametric Mann-Whitney U test will be applied to assess the differences across mean number of events between groups. **Measure:** Monitor caries activity **Time Frame:** 18 months **Description:** The efficacy of the treatment will be assessed for those who fully followed the protocol (per-protocol subjects) by calculating the reduction in risk ratio (RR) and the related number needed to treat (NNT) value. An event is defined as the change of status at tooth level, i.e. the development of a new lesion or the progression of an existing lesion to a more severe stage. Cox Proportional Hazards models will be run to assess the factors associated with caries change of status. Estimates will be reported in the hazard ratio (HR) and their respective 95% confidence interval (95%CI). For all statistical analyses, the statistical significance will be set at α=0.05 **Measure:** Efficacy of the treatment **Time Frame:** 18 months #### Secondary Outcomes **Description:** Create a daily tooth brushing pattern in nurseries, with a particular focus on high risk communities * Habituation of daily tooth brushing in children * Skills in performing tooth brushing **Measure:** Daily tooth brushing pattern **Time Frame:** 12 months **Description:** Qualitative assessment of advantageds and barriers regarding the number of children who benefit from preventive measures will be done by means of interviews with the involved nursery staff **Measure:** Qualitative evaluation of the preventive activities in nurseries **Time Frame:** 12 months **Description:** Qualitative assessment of advantageds and barriers regarding the number of children who benefit from preventive measures will be done by means of interviews with the involved dental hygienists **Measure:** Qualitative evaluation of oral health promotion activities **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * children aged 3-5 years attending public nurseries in Romania Exclusion Criteria: * enamel fluorosis * enamel developmental defects * incapacity to perform tooth brushing by themselves **Healthy Volunteers:** True **Maximum Age:** 5 Years **Minimum Age:** 3 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ruxandra Sava-Rosianu, DMD, PhD **Phone:** 740315848 **Phone Ext:** 40 **Role:** CONTACT #### Locations **Location 1:** **City:** Cluj-Napoca **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Alexandrina Muntean, DMD, PhD - **Phone:** 721638054 - **Phone Ext:** 40 - **Role:** CONTACT **Country:** Romania **Facility:** University of Medicine and Pharmacy Cluj-Napoca **State:** Cluj **Status:** RECRUITING **Zip:** 400083 **Location 2:** **City:** Craiova **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Constantin Daguci, DMD, PhD - **Phone:** 728272222 - **Phone Ext:** 40 - **Role:** CONTACT **Country:** Romania **Facility:** University of Medicine and Pharmacy Craiova **State:** Dolj **Status:** RECRUITING **Zip:** 200349 **Location 3:** **City:** Iaşi **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Alice Murariu, DMD, PhD - **Phone:** 0746203437 - **Phone Ext:** 40 - **Role:** CONTACT **Country:** Romania **Facility:** County School Inspectorate Iasi **State:** Iasi **Status:** RECRUITING **Location 4:** **City:** Târgu-Mureş **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Daniela Esian, DMD, PhD - **Phone:** 729921317 - **Phone Ext:** 40 - **Role:** CONTACT **Country:** Romania **Facility:** University of Medicine and Pharmacy Targu Mures **State:** Mures **Status:** RECRUITING **Zip:** 540142 **Location 5:** **City:** Bucharest **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ruxandra Sfeatcu, DMD, PhD - **Phone:** 722576219 - **Phone Ext:** 40 - **Role:** CONTACT **Country:** Romania **Facility:** University of Medicine and Pharmacy Bucharest **Status:** RECRUITING **Zip:** 050037 #### Overall Officials **Official 1:** **Affiliation:** Victor Babes University if Medicine and Pharmacy Timisoara Romania **Name:** Ruxandra Sava-Rosianu **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000017001 - Term: Tooth Demineralization - 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: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M6928 - Name: Dental Caries - Relevance: HIGH - As Found: Dental Caries - 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 - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life ### Condition Browse Module - Meshes - ID: D000003731 - Term: Dental Caries ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441487 **Acronym:** mPATH-Cloud **Brief Title:** mPATH-Cloud for Colorectal Cancer Screening **Official Title:** Evaluating a Remotely Delivered, Digital Health CRC Screening Intervention Among Racially Diverse Patients of a Community Health Center #### Organization Study ID Info **ID:** 23-1969 #### Organization **Class:** OTHER **Full Name:** UNC Lineberger Comprehensive Cancer Center #### Secondary ID Infos **ID:** R01CA260822 **Link:** https://reporter.nih.gov/quickSearch/R01CA260822 **Type:** NIH ### Status Module #### Completion Date **Date:** 2029-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-07 **Type:** ESTIMATED #### Start Date **Date:** 2025-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institutes of Health (NIH) **Class:** NIH **Name:** National Cancer Institute (NCI) #### Lead Sponsor **Class:** OTHER **Name:** UNC Lineberger Comprehensive Cancer Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study assesses the effectiveness of colorectal cancer (CRC) screening intervention, mobile Patient Technology for Health (mPATH™-Cloud), compared to usual care among subjects who are overdue for CRC screening according to recommendations of the United States Preventive Services Taskforce (USPSTF). The trial randomly selects and enrolls 1,000 eligible subjects served by one federally qualified health center (FQHC) in North Carolina. Subjects are randomized to two study arms, Usual Care (Arm 1) or Mobile Health Decision Support (Arm 2). Usual care consists of a visit-based screening recommendation to complete a stool test (e.g., FOBT, FIT, Cologuard) or referral to a screening colonoscopy. Subjects randomized to the Mobile Health Decision Support (Arm 2) are sent a message by text or US mail, depending on their preferred communication mode as indicated in the electronic health record (EHR), to visit the mPATH™-Cloud website. Subjects who engage with mPATH™-Cloud are invited to answer brief questions to confirm their eligibility and then view a short decision aid video designed to help people choose the CRC screening test (FIT or colonoscopy) that they would like to receive. After watching the video, subjects can choose a CRC screening test. Their primary care provider at the FQHC orders the appropriate test and, where indicated, refers the subjects to a colonoscopy. Subjects who request FIT screening and subjects who do not select any test receive a FIT mailed to their home address. The primary outcome of interest is CRC screening completion within 6 months after randomization as assessed by EHR chart review. A completed screening is any of the following: colonoscopy completion (regardless of indication); 2) at least one FIT test with a normal result; or diagnostic colonoscopy following an abnormal FIT result. We hypothesize that we will observe a higher CRC screening completion rate in the Mobile Health Decision Support intervention arm (Arm 2). This study includes up to three annual rounds of screening eligibility assessment and outreach. Repeated intervention rounds allow us to evaluate whether the intervention can improve adherence to USPSTF recommendations over time. During the 3-year intervention phase, Arm 1 receives usual care only. **Detailed Description:** Subjects randomized to the Mobile Health Decision Support intervention arm (Arm 2) receive a link to mobile Patient Technology for Health (mPATH™-Cloud), a digital health platform designed to alleviate the implementation burden on clinical teams by automating many key steps in the CRC screening process. If the subject uses mPATH-Cloud to select a screening test, mPATH-Cloud notifies the subject's primary care provider at the FQHC. Subjects who request colonoscopy are then referred by their primary care provider to colonoscopy as appropriate. Subjects who request FIT receive a FIT mailed to their home. Primary outcome assessment: To assess intervention effectiveness, CRC screening completion within 6 months of randomization (primary outcome) is assessed by EHR chart review. Screening completion is defined as any of the following: colonoscopy completion (regardless of indication); at least one FIT test with a normal FIT result; or diagnostic colonoscopy following an abnormal FIT result. Secondary outcome assessment: To assess intervention effectiveness on adherence to USPSTF recommendations over time (secondary outcome), the Mobile Health Decision Support intervention is offered annually to Arm 2 subjects for up to 3 consecutive years so long as the subject remains eligible and due for CRC screening as determined by EHR review. CRC screening up-to-datedness will be assessed by EHR chart review over a period of three consecutive years. FIT should be repeated annually, and colonoscopy typically only needs to be repeated once every 10 years. Thus, subjects will be assigned one year per annual FIT completed (e.g., FIT in years 1, 2, and 3 would be assigned 3 years; FIT in year 1, and 3 would be assigned 2 years) and up to 3 years for colonoscopy depending on the year received (e.g., colonoscopy in year 1 would be assigned 3 years, colonoscopy in year 3 would be assigned 1 year). Subjects remain in their originally assigned study arms for the duration of up to three annual rounds of CRC screening outreach. Implementation assessment (exploratory outcome): This study will identify implementation processes and outcomes that will impact future dissemination and scalability. After the trial phase concludes, researchers will interview a subsample of up to 50 subjects to understand factors associated with CRC screening completion among subjects with varying needs and preferences. ### Conditions Module **Conditions:** - Colorectal Cancer **Keywords:** - screening - digital health platform - mPATH™ - Mobile Patient Technology for Health - fecal immunochemical tests - fecal occult blood test - Cancer Screening - Community Health Centers - Implementation Science - Rural health - Telemedicine - Minority Health ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized: Participants are assigned to intervention groups by chance. ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** SCREENING #### Enrollment Info **Count:** 1000 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects randomized to this arm receive a link to a mobile health decision support tool (mPATH™-Cloud). Within mPATH™-Cloud, subjects are invited to answer brief questions to confirm eligibility, view a video to help them identify their CRC screening preference, and request either colonoscopy or fecal immunochemical test (FIT) screening from their primary care provider. Subjects who do not click on the link or select a screening test receive a FIT mailed to their home address. **Intervention Names:** - Behavioral: Mobile Health Decision Support **Label:** Trial Mailed FIT Intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Subjects randomized to this arm receive usual care. Current usual care at the participating community health centers consists of a visit-based colorectal cancer screening recommendation and referral. **Intervention Names:** - Behavioral: Usual care **Label:** Trial Usual Care **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Trial Mailed FIT Intervention **Description:** Subjects randomized to this arm receive a link to a mobile health decision support tool (mPATH™- Cloud). Within mPATH™-Cloud, subjects are invited to answer brief questions to confirm eligibility, view a video to help them identify their CRC screening preference, and request either colonoscopy or fecal immunochemical test (FIT) screening from their primary care provider. Subjects who select FIT, as well as subjects who do not click on the link or select a screening test receive a FIT mailed to their home address. **Name:** Mobile Health Decision Support **Other Names:** - mPATH™-Cloud **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Trial Usual Care **Description:** The study team will send subjects a prompt to visit the mobile health decision support tool (mPATH™-Cloud). Subjects with a mobile phone (as determined by their electronic health record) will receive a link to mPATH-Cloud by text. Subjects with a mailing address, but no mobile phone number in the EHR, will receive a letter inviting them to access mPATH-Cloud via URL code. Within mPATH-Cloud, subjects are invited to answer brief questions to confirm eligibility, view a video to help them identify their CRC screening preference, and request either colonoscopy or fecal immunochemical test (FIT) screening from their primary care provider. Subjects who do not click on the link or select a screening test receive a FIT. **Name:** Usual care **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The proportion of individuals who completed CRC screening using any of the screening modalities recommended by the United States Preventive Service Task Force. Screening modalities could be fecal occult blood test (FIT), fecal occult blood test (FOBT), the stool DNA test combines the FIT ( FIT-DNA), colonoscopy, flexible sigmoidoscopy, flexible sigmoidoscopy with FIT, Computerized Tomography (CT) colonography. **Measure:** Colorectal cancer screening completion rate **Time Frame:** Up to 6 months #### Secondary Outcomes **Description:** Colorectal cancer screening coverage at the time of annual assessment. screening modalities recommended by the United States Preventive Service Task Force. Screening modalities could be fecal occult blood test (FIT), fecal occult blood test (FOBT), the stool DNA test combines the FIT ( FIT-DNA), colonoscopy, flexible sigmoidoscopy, flexible sigmoidoscopy with FIT, Computerized Tomography (CT) colonography. **Measure:** Colorectal cancer screening up-to-datedness **Time Frame:** Baseline,1 year, 2 years, 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 45-73 years at time of enrollment * At average risk for CRC ("average risk" is defined as those subjects who do not have any of the following: documented history in the EHR of CRC, colonic adenomas, family history of CRC, or diagnosis of inflammatory bowel disease) * No record in the EHR of fecal occult blood test (FOBT)/FIT within 12 months, FIT-DNA within 3 years, colonoscopy within 10 years, sigmoidoscopy within 5 years, barium enema within 5 years, or computed tomography (CT) colonography within 10 years of the EHR query date * No record in the EHR of any CRC diagnosis or total colectomy * Active patient of the clinic as documented in the EHR (seen at least 2 times within the past 12 months) * For the second and third study rounds only: No record of a positive (abnormal) CRC screening result in a previous study round Exclusion Criteria: * All individuals meeting any of the exclusion criteria at baseline will be excluded from study participation: * Age younger than 45 years or older than 73 years at the time of enrollment * Not at average risk for CRC ("average risk" is defined as those subjects who do not have any of the following: history with colorectal carcinoma, colonic adenomas, family history of colorectal carcinoma, or diagnosis of inflammatory bowel disease) * Colorectal carcinoma screening in last 12 months Record in the electronic health record (HER) of fecal occult blood test (FOBT)/FIT within 12 months, FIT-DNA within 3 years, colonoscopy within 10 years, sigmoidoscopy within 5 years, barium enema within 5 years, or computed tomography (CT) colonography within 10 years of the EHR query date * Record in the EHR any CRC diagnosis or total colectomy * Not an active client of the clinic as documented in the EHR (not seen at least 2 times within the past 12 months) * For second and third annual study rounds only: Record of a positive (abnormal) CRC screening result in a previous study round **Healthy Volunteers:** True **Maximum Age:** 73 Years **Minimum Age:** 45 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Alexis A Moore, MPH **Phone:** 919-962-5409 **Role:** CONTACT #### Locations **Location 1:** **City:** Chapel Hill **Contacts:** ***Contact 1:*** - **Name:** Alexis A Moor, MPH - **Role:** CONTACT ***Contact 2:*** - **Name:** Leah M Frerichs, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill **State:** North Carolina **Zip:** 27599 **Location 2:** **City:** Winston-Salem **Contacts:** ***Contact 1:*** - **Name:** Aliza Randazzo - **Phone:** 336-716-0844 - **Role:** CONTACT ***Contact 2:*** - **Name:** David P Miller, MD, MS - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Wake Forest University **State:** North Carolina **Zip:** 27157 #### Overall Officials **Official 1:** **Affiliation:** UNC Lineberger Comprehensive Cancer Center **Name:** Leah M Frerichs, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** All of the participant data collected during the trial, after de-identification, will be made available. IPD Sharing Supporting Information Type: Study Protocol, SAP, and Analytic Code. IPD Sharing Time Frame: Beginning 6 months after summary data are published or otherwise made available with no end date. IPD Sharing Access Criteria: Investigators who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to [email protected]. **IPD Sharing:** NO ### References Module #### See Also Links **Label:** Clinical trials at UNC Lineberger **URL:** http://unclineberger.org/patientcare/clinical-trials/clinical-trials ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007414 - Term: Intestinal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000012002 - Term: Rectal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M17890 - Name: Colorectal Neoplasms - Relevance: HIGH - As Found: Colorectal Cancer - ID: M10448 - Name: Intestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M14844 - Name: Rectal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015179 - Term: Colorectal Neoplasms ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441474 **Brief Title:** Understanding and Addressing Rejection of Personalized Breast Cancer Risk Information in Women **Official Title:** Understanding and Addressing Rejection of Personalized Cancer Risk Information #### Organization Study ID Info **ID:** 23-0345.cc #### Organization **Class:** OTHER **Full Name:** University of Colorado, Denver #### Secondary ID Infos **ID:** 1R01CA279953-01 **Link:** https://reporter.nih.gov/quickSearch/1R01CA279953-01 **Type:** NIH ### Status Module #### Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-12 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Cancer Institute (NCI) #### Lead Sponsor **Class:** OTHER **Name:** University of Colorado, Denver #### 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 Understanding and Addressing Rejection of Personalized Cancer Risk Information study is a longitudinal observational study conducted to understand the nature of phenomenon of personalized cancer risk rejection in the context of mammography screening. **Detailed Description:** The Understanding and Addressing Rejection of Personalized Cancer Risk Information study seeks to understand the nature of phenomenon of personalized cancer risk rejection in the context of mammography screening by 1) identifying demographic and psychological factors associated with risk rejection and 2) identify how risk rejection influences risk-concordant mammography seeking behavior. The study will test a priori theory-derived hypotheses about the precursors of risk rejection and the influence of rejection on real-life screening decision making. It will also determine whether, and if so why, risk rejection manifests differently among people of different racial backgrounds. The Breast Cancer Risk Assessment Tool (BCRAT) will be used to asses participant's risk in a Qualtrics survey platform, allowing integration of risk calculation, presentation of personal risk estimates, and survey data collection. This model is designed to estimate breast cancer risk in women 35-84, and uses the following predictors: 1) age, 2) age at first menstrual period, 3) age at first live birth, 4) first-degree relatives with breast cancer, 5) previous breast biopsy with atypical hyperplasia, and 6) race/ethnicity Participants will be required to complete the baseline survey then a 12-month follow-up survey. ### Conditions Module **Conditions:** - Breast Cancer Female **Keywords:** - Risk rejection - Screening behaviour ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 750 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Other Outcomes **Description:** Whether women talked to a health provider about their breast cancer risk and/or received additional breast health services. **Measure:** Number of Participants who engage in additional breast cancer seeking behavior **Time Frame:** After 12 month follow-up #### Primary Outcomes **Description:** Test the Theory of Motivated Reasoning, Bayesian Updating, Trust, and Personal relevance to why participants rejected their personal risk information. **Measure:** Number of Participants who reject their risk information. **Time Frame:** After baseline survey, an average of 1 week **Description:** Interaction of participant's estimated risk and risk rejection on information seeking behavior, screening intention, and screening behavior up to 1 year after the initial survey. **Measure:** Number of Participants who engage in Risk-concordant information seeking, screening intentions, and receipt of screening. **Time Frame:** After 12 month follow-up #### Secondary Outcomes **Description:** Lower educational attainment and lower numeracy are associated with poorer understanding of health information. We will verify that these socio-demographic variables are associated with risk comprehension and explore whether they are also associated with risk rejection **Measure:** Participant score on Objective numeracy **Time Frame:** After baseline survey, an average of 1 week **Description:** Lower educational attainment and lower numeracy are associated with poorer understanding of health information. We will verify that these socio-demographic variables are associated with risk comprehension and explore whether they are also associated with risk rejection **Measure:** Participant score on Subjective numeracy **Time Frame:** After baseline survey, an average of 1 week **Description:** Lower health literacy is associated with poorer understanding of health information. We will verify that these socio-demographic variables are associated with risk comprehension and explore whether they are also associated with risk rejection **Measure:** Participant score on Health literacy **Time Frame:** After baseline survey, an average of 1 week **Description:** Race is associated with education, numeracy and health literacy. We will verify that these socio-demographic variables are associated with risk comprehension and explore whether they are also associated with risk rejection **Measure:** Racial demographic of participants **Time Frame:** After baseline survey, an average of 1 week ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Female sex 2. Age 39-49 (i.e., people who are eligible for routine breast cancer screening and for whom guidelines recommend an informed, risk-based decision) 3. English literacy Exclusion Criteria: 1. Prior diagnosis of 1. breast cancer 2. Ductal carcinoma in situ (DCIS) 3. Lobular carcinoma in situ (LCIS) 4. Known BRCA1/2 gene mutation 5. Cowan syndrome 6. Li-Fraumeni syndrome 7. Having received previous chest radiation for treatment of Hodgkin's lymphoma. **Maximum Age:** 49 Years **Minimum Age:** 39 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT **Study Population:** The study population will be from a community sample and cite respective healthcare systems. Participants will be recruited from a community sample from UCHealth' s metro system and Washington University in St. Louis Barnes Jewish Healthcare system (BJC). Washington University in St. Louis will also recruit in person and through flyers around the community. We will aim for 40% (n=300) of participants identifying as Black. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Damilola Jolaoso, MSc **Phone:** 303-724-2504 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Michelle Eggers **Role:** CONTACT #### Locations **Location 1:** **City:** Aurora **Contacts:** ***Contact 1:*** - **Name:** Laura Scherer, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of Colorado Denver **State:** Colorado **Zip:** 80045 **Location 2:** **City:** Saint Louis **Contacts:** ***Contact 1:*** - **Name:** Erika Waters, PhD, MPH - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Washington University in St. Louis **State:** Missouri **Zip:** 63130 #### Overall Officials **Official 1:** **Affiliation:** University of Colorado, Denver **Name:** Laura Scherer, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Deciding whether or not to share all de-identified participant data. **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441461 **Acronym:** PPJob-II **Brief Title:** Informal Caregivers at Work - Phase 2 **Official Title:** Mental Health and Occupational Outcomes Among Informal Caregivers at Work - a Danish Nationwide Register-based Cohort Study #### Organization Study ID Info **ID:** TeamWorkingLifeDenmark #### Organization **Class:** INDUSTRY **Full Name:** Team Working Life Denmark ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Bispebjerg Hospital **Class:** OTHER **Name:** Herlev and Gentofte Hospital **Class:** UNKNOWN **Name:** HMW Health and Communication **Class:** OTHER_GOV **Name:** National Research Centre for the Working Environment, Denmark #### Lead Sponsor **Class:** INDUSTRY **Name:** Team Working Life Denmark #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Mental health problems are rising among children and adolescents. This may not only impact the child's level of daily functioning but also close family members. Informal caregiving is defined as unpaid care for a sick, disabled, or other closely related person. Providing long-term informal care has been associated with detrimental stress-related outcomes, and being simultaneously active in the labor market has been highlighted as an increased burden for the caregiver. Workplaces are poorly suited for dealing with private stressors despite their potential negative consequences for the caregiver's job status and health. There is a need for improving understanding of how long-term informal caregiving impacts job and health outcomes, as well as for measures minimizing potential negative consequences among at-risk occupational groups. **Detailed Description:** This Danish nationwide observational cohort study examines the associations between employees being a primary informal caregiver for a child or adolescent with mental health problems and the employees' occupational and health outcomes. In addition, we seek to identify modifying psychosocial risk factors at work as well as at-risk occupational groups. The study relies on pre-existing longitudinal data extracted from Danish national registers, including highly reliable information on occupational status, birth information, residence, public transfer payments, income, psychiatric treatment and services, treatment for substance abuse, psychotropic prescription drugs redeemed, as well as background information. In Denmark, all citizens are assigned with a unique identification number enabling merging of national register data included. Caregiver-child relationships are established based on merging of data from birth and household registers. In this study, register data are further merged with information on psychosocial work environment based on national survey data. All data are located at Statistics Denmark, and accessed and analyzed via a logged, secured platform, The Danish Occupational Cohort (DOC\*X) (www.DOC-X.dk). Exposed employees are compared to a reference group of employees without mental health problems at the familiy level matched according to age group, gender (female/male), and socio-occupational status. ### Conditions Module **Conditions:** - Work-Related Stress **Keywords:** - Mental health issue - Work-related illness - Loss of career progression ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 4386647 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All citizens aged 0-25 years and all adults aged 18-67 years residing in Denmark in the period from 2000 to 2008. **Intervention Names:** - Other: Primary informal caregiver at work. **Label:** Danish citizens ### Interventions #### Intervention 1 **Arm Group Labels:** - Danish citizens **Description:** Employees becoming a primary informal caregiver for a child or an adolescent with mental health problems in the period from 2000 to 2018. **Name:** Primary informal caregiver at work. **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Personal gross income is analyzed as series of annual statuses. **Measure:** Personal gross income (Level of analysis: primary informal caregiver) **Time Frame:** Up to 10 years of follow-up. **Description:** Employment is analyzed as series of annual statuses (i.e., number of weeks employed within each year during follow-up). **Measure:** Employment (Level of analysis: primary informal caregiver). **Time Frame:** Up to 10 years of follow-up. **Description:** Long-term sickness absence is analyzed as time-to-event from baseline on the week scale. **Measure:** Long-term sickness absence (Level of analysis: primary informal caregiver). **Time Frame:** Up to 10 years of follow-up. **Description:** Mental health is analyzed as time-to-event from baseline on the week scale whichever comes first: redeemed psychotropic drug prescriptions, treatment for substance abuse or psychiatric hospital services. **Measure:** Mental health (Level of analysis: primary informal caregiver). **Time Frame:** Up to 10 years of follow-up. #### Secondary Outcomes **Description:** Moderation of potential association by psychosocial work environment is based on age- and sex-specific job-exposure matrices (JEM). **Measure:** Moderation of potential associations by psychosocial work environment (Level of analysis: primary informal caregiver) **Time Frame:** JEMs were composed of national survey data collected in 2000 and 2005. **Description:** Moderation by occupational group is based on DISCO-88 codes (International Standard Classification of Occupation, Danish version 1988). **Measure:** Moderation of potential associations by occupational group (Level of analysis: primary informal caregiver). **Time Frame:** Annual data in the period between 2000 and 2018. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Children/adolescents: Citizens aged 0-25 years in the period between 2000 and 2018. Mental disorder is indicated by redeeming of psychotropic medication, treatment for substance abuse, and psychiatric services. Children of reference adult caregivers is defined by having no personal history of a mental disorder. We exclude children born outside of Denmark. * Adults: Citizens aged 18-67 years residing in Denmark, partaking in the work force in the period between 2000-2008, and living with a child in the household at any time until the child's 18th year or being a parent to a child at its birth. Exclusion Criteria: * We exclude all citizens born in the Faroe Islands and in Greenland. We exclude all citizens residing in the Faroe Islands and in Greenland in the period between 2000 and 2018. **Maximum Age:** 67 Years **Minimum Age:** 0 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** This is a nationalwide register-based study of occupational and mental health outcomes of all adult caregivers to children with and without mental health problems. ### Contacts Locations Module #### Locations **Location 1:** **City:** Valby **Country:** Denmark **Facility:** Team Working Life Denmark **Zip:** 2500 #### Overall Officials **Official 1:** **Affiliation:** Team Working Life Denmark **Name:** Johan H Jensen, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Occupational and Environmental Medicine, Copenhagen University Hospital - Bispebjerg & Frederiksberg **Name:** Johan H Jensen, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Statistics Denmark's extensive collections of registers contain a significant potential for research and analysis. In order to use this research and analysis potential in accordance with the current register legislation and Statistics Denmark's data confidentiality principles, Statistics Denmark has established special micro-data schemes (Research Scheme, Authority Scheme and Legislative Model). Through the micro-data schemes, microdata (i.e. individual/single company data) is made available for specific research, investigation and analysis tasks for authorised research/analysis environments. Foreign research/analysis environments cannot be authorised for the scheme, but under certain conditions, foreign users can access data. Further information: https://www.dst.dk/en/TilSalg/Forskningsservice/Dataadgang **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009784 - Term: Occupational Diseases - ID: D000013315 - Term: Stress, Psychological - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC24 - Name: Occupational Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M20559 - Name: Disease Progression - Relevance: LOW - As Found: Unknown - ID: M1167 - Name: Occupational Stress - Relevance: HIGH - As Found: Work Related Stress - ID: M12719 - Name: Occupational Diseases - Relevance: LOW - As Found: Unknown - ID: M16105 - Name: Stress, Psychological - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000073397 - Term: Occupational Stress ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441448 **Acronym:** potentiALS **Brief Title:** potentiALS - Quality of Life Among Patients With Amyotrophic Lateral Sclerosis **Official Title:** potentiALS - A Multi-method Participatory Aproach to Identify Potentials in Improving Quality of Life Among Patients With Amyotrophic Lateral Sclerosis #### Organization Study ID Info **ID:** 01KG2321 #### Organization **Class:** OTHER **Full Name:** University of Leipzig ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-08-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-01-05 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Leipzig University Medical Center #### Lead Sponsor **Class:** OTHER **Name:** University of Leipzig #### Responsible Party **Investigator Affiliation:** University of Leipzig **Investigator Full Name:** Anja Mehnert **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:** Amyotrophic lateral sclerosis (ALS) is a rapidly progressing and disabling disease with the majority of patients dying 3-5 years after symptom onset. Given the high symptom burden, many patients and its caregivers are highly distressed. However, few programs to improve mental health for this patient group exist, and the sparse research implies that programs effective in other medical conditions may not be feasible in ALS patients. Therefore, it is highly needed to involve ALS patients, caregivers and medical staff as contributors into the development of such programs to meet the needs they really have. The envisaged project has two aims: First, the investigators want to examine whether and how it is possible to involve ALS patients in the whole research process despite rapid disease progress and severe functional impairments. Second, the investigators are interested in how contributors (i.e., patients, caregivers and medical staff) would compile a concrete psychotherapeutic program, i.e., how they set priorities in terms of format, content and treatment techniques of such a program. The investigators will closely collaborate with contributors across the whole project in designing the research process, planning assessment as well as interpreting and disseminating the findings. At the end of the study, the investigators will gather contributor feedback on their experience with the participatory approach. Results will provide important information on how ALS patients can be effectively involved in psychosocial intervention research. Identified priorites regarding psychotherapeutic programs will serve as concrete starting points to develop and test a disease-specific program within a subsequent study. **Detailed Description:** Amyotrophic lateral sclerosis (ALS) is a neurogenerative multi-systemic disease with various symptoms including weakness, cramps, pain, inappropriate affect or speech problems. ALS is inevitably fatal, with the majority of patients dying within 3-5 years after symptom onset as a result of ventilatory failure. Given the symptom burden and the fatal nature of the disease, many patients are highly distressed. ALS patients show elevated rates of depressive symptoms and impaired quality of life, and levels of anxiety increase with progressing disease. About one third of patients suffer from moderate or severe hopelessness which in turn is associated with desire for hastened death. The mental burden warrants effective psychological treatments to improve quality of life (QoL) among this patient group. However, few psychosocial interventions studies exist whose results do not allow for strong recommendations due to issues regarding methodology and acceptability. Recently, our own working group failed to apply a psychotherapy effective in palliative cancer patients to ALS patients (publication in preparation, see https://clinicaltrials.gov/ct2/show/NCT03975608). Therefore, concepts feasible in other populations may not meet the specific needs of ALS patients. Indeed, various disease-specific facilitators have been identified such as flexible format, diseasespecific content tailoring, fostering of patient autonomy, but also barriers such as high effort in reaching and undergoing the intervention and functional decline. Based on such findings, psychotherapeutic programs for ALS patients should be co-designed within a participatory approach to overcome problems with feasibility and acceptability. However, the investigators identified only one study applying a similar approach; however, it was placed in a complete different health care context. The investigators herein envisage a conceptual phase closely collaborating with various contributors, i.e., patients, caregivers and medical staff. The first objective is to assess the ability and benefit in collaborating with ALS patients in psychosocial intervention research. As second objective, contributors will prioritize their needs in psychological interventions regarding format, content and techniques. Results will be used in an exploratory trial to co-design a psychotherapeutic program ensuring good feasibility and acceptability. The research questions of the first objective are the following: 1. How high is the response rate of contributors to be involved in this participatory project? 2. Which participative methods are applicable among ALS patients or need to be adapted? 3. How do contributors evaluate the possbility to collaborate in psychosocial intervention research? 4. What are the lessons learned and how can they be transferred to participatory psychosocial intervention research among severe (neurodegenerative) diseases? The main research questions related to the second objective are the following: 5. How do contributors prioritize treatment-related factors in format, content and techniques? 6. Which factor-specific barriers for feasibility and acceptability are anticipated by contributors? 7. What are the main findings to serve as starting point for co-designing a disease-specific treatment program within an exploratory future trial? ### Conditions Module **Conditions:** - Amyotrophic Lateral Sclerosis **Keywords:** - participatory aproach - quality of life - psychotherapeutic program ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 54 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** The study is in a monocentric, exploratory, participatory study conceptualization phase. Within the study, a mixed-methods assessment involves various interview and group exercise formats among scientists, medical personnel, affected individuals, and their caregivers to develop components for a future psychotherapeutic program for ALS patients and their caregivers. Therapists provide an overview of therapy forms by presenting components based on format, content, and applied techniques. Case studies and focus groups are used for practical experience for the participants. Participants qualitatively assess the significance of therapeutic approaches and make a quantitative prioritization to establish a ranking of therapy components. **Name:** case focus groups **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The investigators will assess the amount of eligible patients which are willing to participate in the study relative to the amount of patients who were invited to participate. **Measure:** Response rate **Time Frame:** through study completion, an average of 1 year #### Secondary Outcomes **Description:** Assessed by a questionnaire, the Amyotrophic Lateral Sclerosis Assessment Questionnaires - short form (ALSAQ-5). The total score across the 5 items, rated on a 4-point Likert scale, will be presented (range: 0 - 20). Higher values indicate higher quality of life.enable ranking of preferences as well as qualitative focus groups/interviews for in-depth analyses. **Measure:** Level of Quality of Life **Time Frame:** through study completion, an average of 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients met criteria for definite/laboratory-supported probable/clinically probable/possible familial or sporadic ALS (diagnostically synonymous with MND) or MND variants (progressive muscular atrophy or primary lateral sclerosis according to the revised El Escorial criteria * ≥ 18 years old * fluent in German * ability to communicate thoughts and feelings * ability to provide written consent * anticipated remaining lifespan of ≥ 9 months. Exclusion Criteria: * under 18 years old * had a clinical need for gastrostomy feeding or non-invasive ventilation * had a diagnosis of dementia * inability to consent **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study population includes 20 dyads of individuals affected by ALS and their caregivers, 4 expert patients, and 10 healthcare professionals. The recruitment is conducted through patient networks and personal contacts established by the patient representative and the project leader (e.g., within neuropalliative networks). The project leader will also invite medical personnel through his networks and in the course of his clinical work (e.g., within the "Clinic for Motor Neuron Diseases" at Leipzig University Hospital) to participate in the study. Affected individuals may also be invited to participate in the study by the project leader during their medical treatment. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Moritz Metelmann, PhD **Phone:** +49 341 97 24209 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Svenja Heyne, MSc. Psych **Phone:** +49 341 97 15438 **Role:** CONTACT #### Locations **Location 1:** **City:** Leipzig **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Moritz Metelmann, PhD - **Phone:** +49 341 - 97 24209 - **Role:** CONTACT ***Contact 2:*** - **Name:** Anja Mehnert, PhD - **Role:** SUB_INVESTIGATOR **Country:** Germany **Facility:** University Medical Center Leipzig **State:** Saxony **Status:** RECRUITING **Zip:** 04103 #### Overall Officials **Official 1:** **Affiliation:** Universitätsklinikum Leipzig **Name:** Moritz Metelmann, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000013118 - Term: Spinal Cord Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000057177 - Term: TDP-43 Proteinopathies - ID: D000057165 - Term: Proteostasis Deficiencies - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15415 - Name: Sclerosis - Relevance: HIGH - As Found: Sclerosis - ID: M18879 - Name: Motor Neuron Disease - Relevance: HIGH - As Found: Lateral Sclerosis - ID: M4024 - Name: Amyotrophic Lateral Sclerosis - Relevance: HIGH - As Found: Amyotrophic Lateral Sclerosis - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M15915 - Name: Spinal Cord Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M28759 - Name: TDP-43 Proteinopathies - Relevance: LOW - As Found: Unknown - ID: M28747 - Name: Proteostasis Deficiencies - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life - ID: T4699 - Name: Primary Lateral Sclerosis - Relevance: HIGH - As Found: Lateral Sclerosis - ID: T349 - Name: Amyotrophic Lateral Sclerosis - Relevance: HIGH - As Found: Amyotrophic Lateral Sclerosis ### Condition Browse Module - Meshes - ID: D000016472 - Term: Motor Neuron Disease - ID: D000000690 - Term: Amyotrophic Lateral Sclerosis - ID: D000012598 - Term: Sclerosis ### Intervention Browse Module - Browse Branches - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441435 **Brief Title:** The Effect of AC-134 in Chronic Kidney Diseases **Official Title:** To Investigate the Protective Effect of AC 134 in Chronic Kidney Diseases. #### Organization Study ID Info **ID:** SF23520C #### Organization **Class:** OTHER **Full Name:** Taichung Veterans General Hospital ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-24 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** All Clean Health Co., Ltd #### Lead Sponsor **Class:** OTHER **Name:** Taichung Veterans General 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 objective is to explore the effects of adding AC-134 on renal function, proteinuria, uremic toxins, and metabolism-related markers in chronic kidney disease. **Detailed Description:** Chronic kidney disease (CKD) management primarily focuses on addressing associated complications such as hypertension, diabetes mellitus, cardiovascular disease, and proteinuria. In addition to standard therapies, reducing the accumulation of toxins, particularly gut-derived uremic toxins like indoxyl sulfate (IS) and p-cresol sulfate (PCS), may help alleviate uremia symptoms. This study assesses the impact of oral AC-134 capsules containing activated charcoal adsorbent on CKD patients. The assessment will include evaluating changes in renal function, proteinuria, uremic toxins, and metabolism-related markers. ### Conditions Module **Conditions:** - Nephrology **Keywords:** - Chronic Kidney Diseases - Activated charcoal ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Low-protein diet strategies combined with AC-134 capsules **Intervention Names:** - Dietary Supplement: Low protein diet with AC-134 **Label:** Intervention group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Low-protein diet strategies **Intervention Names:** - Other: Standard treatment **Label:** Control group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention group **Description:** Low protein diet combined with AC-134 Dosage: 2 capsules,three times/day **Name:** Low protein diet with AC-134 **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Control group **Description:** Low protein diet **Name:** Standard treatment **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The eGFR level is a maker for kidney function **Measure:** Estimated glomerular filtration rate (eGFR) measurement **Time Frame:** Baseline to 3 months **Description:** Blood Urea Nitrogen **Measure:** Blood Urea Nitrogen (BUN) levels **Time Frame:** Baseline to 3 months **Description:** The concentration of p-cresol sulfate level, indoxyl sulfates level, and acrolein in the subjects' blood samples **Measure:** Uremic toxins assay **Time Frame:** Baseline to 3 months #### Secondary Outcomes **Description:** The concentration of ALT, AST, total bilirubin and direct bilirubin in the subjects' blood samples **Measure:** Liver function **Time Frame:** Baseline to 3 months **Description:** The concentration of inflammation makers in the subjects' blood samples **Measure:** Inflammation makers **Time Frame:** Baseline to 3 months **Description:** The concentration of albumin, wbc and uric acid in the subjects' blood samples **Measure:** Nutrition status **Time Frame:** Baseline to 3 months **Description:** The concentration of total cholesterol , triglyceride , HDL-cholesterol and LDL-cholesterol in the subjects' blood samples **Measure:** Lipid analysis **Time Frame:** Baseline to 3 months **Description:** The concentration of fasting sugar and HbA1C in the subjects' blood samples **Measure:** Sugar test **Time Frame:** Baseline to 3 months **Description:** It will measure by the Kidney Disease Quality of Life (\[KDQOL\]-SF™) questionnaire **Measure:** The quality of life **Time Frame:** Baseline to 3 months **Description:** The concentration of hemoglobin (Hb) in the subject's blood samples **Measure:** Anemia test **Time Frame:** Baseline to 3 months **Description:** Urine specimen collection will be evaluated on the spot and 24-hour urine protein **Measure:** Urine protein analysis **Time Frame:** Baseline to 3 months **Description:** There will be collected by food models or a photography atlas to estimate portion size **Measure:** 24-hour Dietary recall **Time Frame:** Baseline to 3 months **Description:** There will be collected by questionnaires symptoms or chief complaints **Measure:** Gastrointestinal symptoms measures **Time Frame:** Baseline to 3 months **Description:** Hand grip strength was measured by grip strength device **Measure:** Grip strength levels **Time Frame:** Baseline to 3 months **Description:** The concentration of blood gas test in the subject's blood samples **Measure:** Blood gas **Time Frame:** Baseline to 3 months **Description:** The concentration of electrolytes analysis in the subject's blood samples **Measure:** Electrolytes Analysis **Time Frame:** Baseline to 3 months **Description:** The concentration analysis in the subject's blood or urine samples, such as MDA **Measure:** Mitochondrial oxidative stress **Time Frame:** Baseline to 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged 20-90 years. * Diagnosed with stage 3-5 chronic kidney disease, excluding dialysis patients. * Signed informed consent is required before enrollment. Exclusion Criteria: * Use of other brand-activated charcoal supplements during the study period. * Pregnant or lactating women. * Patients who have undergone kidney transplantation. * Obstructive nephropathy within the past month. * Acute kidney injury within the past three months. * Gastrointestinal bleeding or severe constipation within the past three months. * Patients with active malignancy within the past two years. * Severe cardiovascular diseases such as congestive heart failure New York class III-IV or cerebrovascular disease * Severe liver disease, such as liver cirrhosis with ascites. * Active infectious disease **Maximum Age:** 90 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Wen-Ching Yang **Phone:** (04)23592525 **Phone Ext:** 2626 **Role:** CONTACT #### Locations **Location 1:** **City:** Taichung **Country:** Taiwan **Facility:** Taichung Veterans General Hospital **State:** ROC **Zip:** 40705 #### Overall Officials **Official 1:** **Affiliation:** Division of Nephrology in Taichung Veterans General Hospital **Name:** Cheng-Hsu Chen, MDPHD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: 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 - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M5852 - Name: Charcoal - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441422 **Brief Title:** Blood Flow Restriction Training for People With Disabilities **Official Title:** Effectiveness of Low Load Resistance Training With Blood Flow Restriction in Individuals With Disabilities #### Organization Study ID Info **ID:** PRO00051215 #### Organization **Class:** OTHER **Full Name:** Medical College of Wisconsin ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Medical College of Wisconsin #### Responsible Party **Investigator Affiliation:** Medical College of Wisconsin **Investigator Full Name:** Beth Weinman **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** A large portion of the American population live with disabilities. People with disabilities can find it difficult to perform standard exercise routines. Regular exercise is necessary to be healthy, especially as people age. Lack of exercise can lead to secondary health concerns, like loss of muscle mass, diabetes, heart attack or stroke, to name a few. For exercise to be most beneficial, a certain degree of intensity must be achieved. Low load blood flow restriction training may be able to mimic the intensity of beneficial exercise without actually exercising hard. It may be a good option for people with disabilities who find it difficult to exercise. **Detailed Description:** A significant portion of the American population currently lives with a disability. There are about 300,000 Americans living with a spinal cord injury (SCI) with approximately 18,000 new cases each year. Cerebrovascular accidents (CVA), or strokes, occur at 795,000 new cases per year in the USA with strokes being the third-leading cause of death and disability combined in the world3. There are about 750,000 US adults living with multiple sclerosis (MS), 30,000 US adults with ALS, about 1400 Americans are born each year with spina bifida, about 11,000 Americans are born each year with cerebral palsy, and there were 1.6 million American amputees as of 2005, with that number expected to double by 2050. These disabilities tend to reduce the activity levels of these individuals, which puts them at an increased risk of developing comorbidities such as obesity, insulin resistance, dyslipidemia, and more. These comorbidities are often already present in those who have had a CVA, and those who are older experience an even greater burden than those who are younger. Thus, exercise regimens are crucial to maintaining their health. Aging is associated with an increase in susceptibility to injury and a decrease in functional ability related to a decrease in muscle size and strength. This age-related decrease is also known as primary sarcopenia. Resistance exercise, such as weightlifting, has been shown to improve muscle size and strength and functional ability in elderly individuals, and resistance exercise is widely regarded as the best method to slow the progression of primary sarcopenia. Resistance exercise and physical activity has also been shown to reduce the odds of developing sarcopenia later in life, suggesting an impetus for beginning an exercise regimen while young, though any age will benefit. Blood flow restriction (BFR) training is a method of exercise that involves restricting the participant's blood flow to the target muscle group during exercise. Historically, training to increase muscle thickness and strength occurs at 70% of a person's 1 repetition maximum (1RM), which is the maximum weight someone can lift in one repetition (rep) of a given exercise. For example, if someone's 1RM for barbell biceps curl is 100lbs, he could train at 70lbs for 3 sets of 8-12 to increase his biceps curl 1RM and the size of his biceps. This training is hereto referred as high intensity resistance training (HLRT). Training at 30-50% 1RM with BFR, hereto referred as low load blood flow restriction training (LLBFR), increases muscle thickness similar to training at 50-80% 1RM without BFR. This also results in an increase in strength due to the increase in overall muscle mass. LLBFR training regimens also display greater increases in muscle size and strength when compared to identical exercise regimens but without BFR. So, training barbell biceps curl at 30-50lbs with blood flow restriction will increase biceps size similarly to our HLRT example. It will increase biceps strength too, but likely not to the same degree as our HLRT example. However, the increase in biceps strength and size in this LLBFR example will be greater than if this person trained at 30-50lbs but without BFR. Thus, LLBFR can induce similar benefits to traditional HLRT but with a much lighter load. Due to the efficacy and efficiency of LLBFR in increasing muscle size and strength, it has been proposed as an alternate exercise regimen for those unable to tolerate, or are contraindicated for, traditional HLRT, such as the elderly or individuals with disabilities. This study proposes to examine if LLBFR is beneficial when compared to traditional low load resistance training. ### Conditions Module **Conditions:** - Weakness, Muscle **Keywords:** - Disability - Blood flow restriction - Low load blood flow restriction training ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 24 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Low load resistance training routine at 30-50% of a person's 1-repetition maximum with arterial occlusion pressure at 80% **Intervention Names:** - Other: Blood flow restriction training **Label:** Low load resistance training with blood flow restriction **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Low load resistance training routine at 30-50% of a person's 1-repetition maximum **Intervention Names:** - Other: No blood flow restriction training **Label:** Low load resistance training **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Low load resistance training with blood flow restriction **Description:** Participants randomized to blood flow restriction training will complete low load resistance training exercises while the limb is occluded at 80% arterial occlusion pressure. **Name:** Blood flow restriction training **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Low load resistance training **Description:** Participants randomized to no blood flow restriction training will complete low load resistance without occlusion. **Name:** No blood flow restriction training **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** This outcome will measure the efficacy of low load blood flow restriction training (LLBFR) on muscle strength. The difference in muscle strength as measured by change in 1-repetition maximum weight in pounds will be compared in individuals training with LLBFR on their arm extensors and individuals training with low load resistance training (LLRT) on their arm extensors compared to their baseline. **Measure:** Difference in strength between low load blood flow restriction resistance training and low load resistance training **Time Frame:** 6 weeks **Description:** This outcome will measure the efficacy of low load blood flow restriction training (LLBFR) on arm circumference. The difference in arm circumference as measured by tape measure will be the change in centimeters in individuals training with LLBFR on their arm extensors compared to individuals training with low load resistance training (LLRT) on their arm extensors when compared to their respective baseline. **Measure:** Difference in arm circumference between low load blood flow restriction resistance training and low load resistance training **Time Frame:** 6 weeks **Description:** This outcome will measure the efficacy of low load blood flow restriction training (LLBFR) on muscle thickness. The difference in muscle thickness as measured by ultrasound will be the change in centimeters in individuals training with LLBFR on their arm extensors compared to individuals training with low load resistance training (LLRT) on their arm extensors when compared to their respective baseline. **Measure:** Difference in muscle thickness change between low load blood flow restriction resistance training and low load resistance training **Time Frame:** 6 weeks #### Secondary Outcomes **Description:** Response to training in individuals with disabilities. The results of LLBFR on muscle strength as measured by change in pounds of 1-repetition maximum to the arm extensors will be compared between those with disabilities and those without. **Measure:** The interaction effect between disability status (disable versus able-bodied) and training group (LLBFR and LLRT) on the change in strength. **Time Frame:** 6 weeks **Description:** Response to training in individuals with disabilities. The results of LLBFR on arm circumference as measured by change in centimeters as measured by tape measure to the arm extensors will be compared between those with disabilities and those without. **Measure:** The interaction effect between disability status (disable versus able-bodied) and training group (LLBFR and LLRT) on the change in arm circumference. **Time Frame:** 6 weeks **Description:** Response to training in individuals with disabilities. The results of LLBFR on muscle thickness as measured by ultrasound in change in centimeters to the muscle thickness will be compared between those with disabilities and those without. **Measure:** The interaction effect between disability status (disable versus able-bodied) and training group (LLBFR and LLRT) on the change in muscle thickness. **Time Frame:** 6 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or female * Age \> or = 18 * English speaking * Able to understand and perform upper extremity exercises Exclusion Criteria: * Pregnant * Body mass index \>40 kg·m-2 * Uncontrolled hypertension (\>150/90 mmHg) * Presence of neuromuscular junction and other muscle diseases * Myocardial infarction in the past 6 months * Unstable cardiovascular disease * History of an upper limb deep vein thrombosis * History of autonomic dysreflexia * Upper extremity fracture within the last 6 months **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:** Beth Weinman, DO **Phone:** 414-955-1922 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Meghann Sytsma **Phone:** 414-955-1922 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## 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: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M4554 - Name: Asthenia - Relevance: LOW - As Found: Unknown - ID: M20944 - Name: Muscle Weakness - Relevance: HIGH - As Found: Weakness, Muscle - 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:** NCT06441409 **Acronym:** MASLD **Brief Title:** Serum Ferritin Levels and Metabolic Dysfunction Associated Steatotic Liver Disease **Official Title:** Serum Ferritin Levels Can Predict Severity and Longterm Outcomes in Patients With Metabolic Dysfunction Associated Steatotic Liver Disease #### Organization Study ID Info **ID:** 22218 #### Organization **Class:** OTHER **Full Name:** The Third Xiangya Hospital of Central South University #### Secondary ID Infos **Domain:** the Natural Science Foundation of Hunan Province **ID:** No. 2022JJ40749 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2023-04-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-04-30 **Type:** ACTUAL #### Start Date **Date:** 2022-10-18 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-04-15 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The Third Xiangya Hospital of Central South University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to learn if serum ferritin levels has correlated with metabolic dysfunction associated steatotic liver disease（MASLD）. It will also learn about the effect of lifestyle intervention on serum ferritin levels and MASLD. The main questions it aims to answer are: Does serum ferritin levels predict the occurence and development of MASLD? Does liver iron overload has correlated with liver fat deposition? Does serum ferritin levels and MASLD got some degree of remission after weight lose with lifestyle intervention? Researchers will compare the liver fatty, liver iron depositon and serum ferritin levels after lifestyle intervention using self pre-and post-control . Participants will: Receive the lifestyle intervention in outpatient. Visit the clinic once after 6 months for checkups and tests. Keep a diary of their diet. **Detailed Description:** The diagnosis of MASLD was based on MRI. The diet scheme was formulated based on the results of body composition analysis. ### Conditions Module **Conditions:** - Nonalcoholic Fatty Liver Disease - Fertility Disorders ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Patients were intervened with lifestyle only. ##### Masking Info **Masking:** NONE **Masking Description:** open label **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 185 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients were intervened with lifestyle only and returned to clinic for tests in 6 months. Lifestyle intervention included the diet and exercise. Diet was an energy-restricted balanced diet. Exercise requires 5 days a week and 30 minutes every day. **Intervention Names:** - Behavioral: Lifestyle intervention **Label:** lifestyle intervention **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - lifestyle intervention **Description:** Patients were intervened with lifestyle only and returned to clinic for tests in 6 months. Lifestyle intervention included the diet and exercise. Diet was an energy-restricted balanced diet. Exercise requires 5 days a week and 30 minutes every day. **Name:** Lifestyle intervention **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Categorical variables were summarized as numbers (percentages), continuous variables with normal distributions as means (SDs), and continuous variables with non-normal distributions as medians (interquartile ranges \[IQRs\]). Treatment-induced changes were tested by the paired t test and Wilcoxon signed-rank test, as appropriate. The unpaired t test, Mann-Whitney U test, and Kruskal-Wallis test were used for group comparisons. Correlations between site-specific fat mobilization and clinical outcomes were investigated by calculating Pearson correlation coefficients and Pearson partial correlation coefficients. Two-sided P \< 0.05 was considered statistically significant. Statistical analyses were performed using R software version 4.1.2 (http://www.r-project.org/). **Measure:** The correlation between liver fat and liver iron. **Time Frame:** Patients were return to hospital for MRI after lifestyle intervention for 6 months. **Description:** Categorical variables were summarized as numbers (percentages), continuous variables with normal distributions as means (SDs), and continuous variables with non-normal distributions as medians (interquartile ranges \[IQRs\]). Treatment-induced changes were tested by the paired t test and Wilcoxon signed-rank test, as appropriate. The unpaired t test, Mann-Whitney U test, and Kruskal-Wallis test were used for group comparisons. Correlations between site-specific fat mobilization and clinical outcomes were investigated by calculating Pearson correlation coefficients and Pearson partial correlation coefficients. Two-sided P \< 0.05 was considered statistically significant. Statistical analyses were performed using R software version 4.1.2 (http://www.r-project.org/). **Measure:** The correlation between serum ferritin levels and liver fat. **Time Frame:** Patients were return to hospital for MRI and serum tests after lifestyle intervention for 6 months. #### Secondary Outcomes **Description:** defined by percentage MRI-based fat loss. Calculated as (initial measurement minus follow-up measurement) / (initial measurement) × 100 and predefined to be assessed at 6-month follow-up. MRI scans were acquired with an INGENIA ELITION X (Philips Medical Systems Nederland B.V.). **Measure:** The site-specific fat mobilization after 6 months' lifestyle intervention. **Time Frame:** After 6 months intervention, patients were return to hospital for MRI analysis. **Description:** Through self control, carry on the statistical analysis to the results of weight. For brevity, absolute changes of continuous variables were designated Δweight. **Measure:** The effect of lifestyle intervention on weight. **Time Frame:** After 6 months intervention, patients were return to hospital for Body composition analysis. **Description:** Through self control, carry on the statistical analysis to the results of fat mass.For brevity, absolute changes of continuous variables were designated ΔVFA（cm2）. **Measure:** The effect of lifestyle intervention on fat mass. **Time Frame:** After 6 months intervention, patients were return to hospital for MRI analysis. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * age between 18 and 80 years outpatients Exclusion Criteria: * previous diagnosis of diabetes acute and chronic complications acute and chronic inflammation long-term history of heavy alcohol consumption **Healthy Volunteers:** True **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Changsha **Country:** China **Facility:** the Third Xiangya Hospital of Central South University **State:** Hunan **Zip:** 410013 #### Overall Officials **Official 1:** **Affiliation:** The Third Xiangya Hospital of Central South University **Name:** Ping Jin **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004066 - Term: Digestive System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11107 - Name: Liver Diseases - Relevance: HIGH - As Found: Liver Disease - ID: M8375 - Name: Fatty Liver - Relevance: HIGH - As Found: Fatty Liver - ID: M30540 - Name: Non-alcoholic Fatty Liver Disease - Relevance: HIGH - As Found: Nonalcoholic Fatty Liver Disease - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: T5868 - Name: Visceral Steatosis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008107 - Term: Liver Diseases - ID: D000005234 - Term: Fatty Liver - ID: D000065626 - Term: Non-alcoholic Fatty Liver Disease ### 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:** NCT06441396 **Brief Title:** Comparison of Telerehabilitation and Video Basics and Exercise in Older Adult Individuals **Official Title:** Comparison of the Effects of Telerehabilitation and Video Fundamentals of Exercise on Physical Performance and Body Composition in Older Adult Individuals #### Organization Study ID Info **ID:** Hacettepe University-Ftr-Oe #### Organization **Class:** OTHER **Full Name:** Hacettepe University ### Status Module #### Completion Date **Date:** 2023-12-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-12-01 **Type:** ACTUAL #### Start Date **Date:** 2002-01-31 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-18 **Study First Submit QC Date:** 2024-05-31 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Lokman Hekim Üniversitesi #### Lead Sponsor **Class:** OTHER **Name:** Hacettepe University #### Responsible Party **Investigator Affiliation:** Hacettepe University **Investigator Full Name:** Özgün Elmas **Investigator Title:** Research assistant **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Researchers could not find a study in the literature examining the effectiveness of different technological methods in exercise practices in older adults. Based on this, the aim of this study is to compare the effect of exercise intervention using telerehabilitation and video-based rehabilitation method on physical performance, muscle mass, fat percentage and body mass index. **Detailed Description:** Telerehabilitation is defined as the use of information and telecommunication technologies to provide healthcare services over a long distance between a patient and a healthcare professional. It involves a multi-component approach such as remote monitoring, e-learning and tele-coaching. The American Telemedicine Association defines telerehabilitation as "the delivery of rehabilitation services through information and communication technologies." It also states that telerehabilitation encompasses a range of rehabilitation and habilitation services, including assessment, monitoring, prevention, intervention, supervision, education, counseling and counseling. In cases where access to healthcare services is limited, it is recommended to use telerehabilitation to provide effective rehabilitation services to patients. Telerehabilitation is an emerging field that is growing rapidly and becoming an important part of telemedicine and e-health. It is hypothesized that it may offer new possibilities to deliver intervention strategies across the continuum of rehabilitation and that the distance barrier can be minimized to increase access. Minimizing the distance barrier can be achieved through various modes of telecommunications, including voice, video and virtual reality. Telerehabilitation refers to services provided by occupational therapists, speech therapists, and physical therapists. It provides continuity of service throughout the entire rehabilitation cycle, including assessment, intervention, consultation and education, and has emerged as an effective support for providing home rehabilitation care to recently discharged patients. In the practice of telerehabilitation, it is assumed that patients have various advantages in many respects, as they have the opportunity to perform rehabilitation in their own social environment, can avoid transportation problems, can personally arrange their exercise hours, and are encouraged to self-manage their disease. The use of telerehabilitation can promote standardization, improve patient compliance with exercise programs, and reduce costs. Additionally, this type of technology can also facilitate participation in rehabilitation when patients cannot access traditional physical therapy services due to geographic challenges or inability to travel. A Cochrane review found that the technologies used in telerehabilitation interventions were well accepted by patients, but further studies were needed to increase the evidence base for clinical benefits. Participation in exercise is low in elderly individuals, and the Covid 19 pandemic has further reduced the low participation of the elderly in exercise. For this reason, telerehabilitation for the elderly is becoming more and more important day by day. Researchers could not find a study in the literature examining the effectiveness of different technological methods in exercise practices in older adults. Based on this, the aim of this study is to compare the effect of exercise intervention using telerehabilitation and video-based rehabilitation method on physical performance, muscle mass, fat percentage and body mass index. Location of the research: Hacettepe University Faculty of Physical Therapy and Rehabilitation Geriatric Rehabilitation Unit and Lokman Hekim University Population of the study, sample, research group: The minimum number of participates required to be included in the study was determined by power analysis. It is planned to include individuals applying to Hacettepe University Faculty of Physical Therapy and Rehabilitation Geriatric Rehabilitation Unit and Lokman Hekim University to participate in the research. Individuals who give their written consent and meet the inclusion criteria will be included in the study. Study design: Signed consent was obtained from the participants who agreed to participate in the research, and the research was conducted by the researchers within the framework of the ethical rules determined according to the Declaration of Helsinki. The researchers followed the instructions in the CONSORT checklist used in randomized controlled trials while writing the article. Individuals over 65 years old who participated in the study were divided into 2 groups (TR and VTR) by computer-generated randomization (allocation ratio of 1:1). The researchers sent only videotaped exercises to the VTR group and were asked to follow the exercises in the videos. In order to better understand the exercises, the researchers sent these recorded videos to the TR group, and the researchers also had the participants do the exercises online with the help of TR using the WhatsApp program. Before and after the intervention, the participants were evaluated by the researchers in terms of physical performance, muscle mass, fat ratio and BMI. These evaluation results were compared within and between groups. The exercises performed by both participant groups were performed for 25-45 minutes, 3 days a week for 6 weeks. Both participates groups were given the same exercises. ### Conditions Module **Conditions:** - Healthy **Keywords:** - Tele-rehabilitation - Exercise - Elderly ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Telerehabilitation is a group Video-based rehabilitation is the other group ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 30 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** It is a group that performs the given exercise program mutually with the physiotherapist via video connection. **Intervention Names:** - Other: Telerehabilitation **Label:** Telerehabilitation **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** This is the group that does the given exercises by watching the video. **Intervention Names:** - Other: Video-based rehabilitation (VTR) **Label:** Video-based rehabilitation **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Telerehabilitation **Description:** In the study, the VTR guru was given video footage of 15 exercises previously recorded on camera. The individuals in this group were made to do the exercises together online via the WhatsApp program. Exercises in both groups were planned for 6 weeks, 3 days a week, 25-45 minutes. The main program consists of 15 calisthenic exercises involving the lower extremity, upper extremity and trunk large muscle groups. Exercises in both groups were planned for 6 weeks, 3 days a week, 25-45 minutes. The number of repetitions of each exercise started with 10 and was increased by 5 repetitions every two weeks until it reached 20 repetitions. **Name:** Telerehabilitation **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Video-based rehabilitation **Description:** In the study, the VTR guru was given video footage of 15 exercises previously recorded on camera. Participants were asked to exercise by watching these videos. In addition, these individuals were interviewed once a week to check the progress of the exercise program. Video images were sent to the intervention group for informational purposes, and the individuals in this group were made to do the exercises together online via the WhatsApp program. **Name:** Video-based rehabilitation (VTR) **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Muscle strength was evaluated with a digital dynamometer for the deltoideus-anterior and quadricepsfemoris muscles. The tests were repeated three times on the right and left sides for each muscle, and the average of the three evaluations was recorded in Newtons (N). Jamar hand dynamometer recommended by the American Hand Therapists Association was used to evaluate hand grip strength. Hand grip strength was measured in a sitting position, with the shoulder in adduction and neutral rotation, the elbow in 90 degrees of flexion, the forearm in the middle position and supported, and the wrist in neutral. During the test, 3 measurements were made for hand grip, with a one-minute break between each measurement, and the average was recorded). **Measure:** Evaluation of muscle strength **Time Frame:** six weeks #### Primary Outcomes **Description:** It is performed to evaluate lower extremity endurance. The individual is asked to fully stand up from a chair without armrests and sit back down for 30 seconds. The exact number of standing up and sitting down during thirty seconds is recorded. An increase in the number of starts means better endurance **Measure:** Physical performance tests- 30 seconds chair stand test: **Time Frame:** six weeks **Description:** Time up \& go test (TUG): It is used to evaluate balance and functional mobility. The person is seated on a chair without armrests, then the person is asked to get up from the chair, walk 3 m, return to the chair and sit down. The time it takes to complete the test is recorded. Decreasing test completion time means better performance **Measure:** Physical performance tests- 30 seconds chair stand test-Time up & go test (TUG): **Time Frame:** six weeks **Description:** Single leg stance: Without shoes, they stand on one leg with their hands on their hips, one knee bent, and time is kept. It is performed 3 times for each extremity, the best score is recorded (16). **Measure:** Physical performance tests- Single leg stance: **Time Frame:** six weeks **Description:** It is used to determine the functional exercise capacities of participants. Participants are asked to walk quickly for 6 minutes. The distance walked during this time is measured in meters. Long distance indicates better physical performance **Measure:** Physical performance tests- Six-minute walk test: **Time Frame:** six weeks #### Secondary Outcomes **Description:** Researchers measure the participants' height using a meter. This recorded value in meters (m) will then be entered into the Inboby 120 device, which gives the participant's weight in kilograms (kg) to the researchers with the help of electrodes. **Measure:** Assessing the participants' height **Time Frame:** six weeks **Description:** Inbody 120 device shows the participant's body mass index Muscle mass (kg), fat percentage (%) and Body Mass Index (BMI) (kg/m²) values of the participants were measured with the InBody 120 (Biospace, California, USA) bioimpedance analyzer. The device analyzes via tetra polar bio-electrical impedance (BIA). The measurement frequency is between 20-100 kHz. Electric currents pass more easily through body tissues where there is a lot of water (such as blood, urine and muscles) than through other tissues (such as bone, fat or air). With this method, the speed and strength of electrical currents passing through the body are measured and these results are used to determine information such as height, weight, gender and body composition of the person. **Measure:** Evaluation of body mass index **Time Frame:** six weeks **Description:** Inbody 120 device shows the participant's general body weight. Muscle mass (kg), fat percentage (%) and Body Mass Index (BMI) (kg/m²) values of the participants were measured with the InBody 120 (Biospace, California, USA) bioimpedance analyzer. The device analyzes via tetra polar bio-electrical impedance (BIA). The measurement frequency is between 20-100 kHz. Electric currents pass more easily through body tissues where there is a lot of water (such as blood, urine and muscles) than through other tissues (such as bone, fat or air). With this method, the speed and strength of electrical currents passing through the body are measured and these results are used to determine information such as height, weight, gender and body composition of the person. **Measure:** Evaluation of height **Time Frame:** six weeks **Description:** Inbody 120 device shows the participant's muscle mass. Muscle mass (kg), fat percentage (%) and Body Mass Index (BMI) (kg/m²) values of the participants were measured with the InBody 120 (Biospace, California, USA) bioimpedance analyzer. The device analyzes via tetra polar bio-electrical impedance (BIA). The measurement frequency is between 20-100 kHz. Electric currents pass more easily through body tissues where there is a lot of water (such as blood, urine and muscles) than through other tissues (such as bone, fat or air). With this method, the speed and strength of electrical currents passing through the body are measured and these results are used to determine information such as height, weight, gender and body composition of the person. **Measure:** Evaluation of muscle mass **Time Frame:** six weeks **Description:** Inbody 120 device shows the participant's ratio. Muscle mass (kg), fat percentage (%) and Body Mass Index (BMI) (kg/m²) values of the participants were measured with the InBody 120 (Biospace, California, USA) bioimpedance analyzer. The device analyzes via tetra polar bio-electrical impedance (BIA). The measurement frequency is between 20-100 kHz. Electric currents pass more easily through body tissues where there is a lot of water (such as blood, urine and muscles) than through other tissues (such as bone, fat or air). With this method, the speed and strength of electrical currents passing through the body are measured and these results are used to determine information such as height, weight, gender and body composition of the person. **Measure:** Evaluation of fat ratio **Time Frame:** six weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Not having cognitive problems * Being over 65 years old * Volunteering to participate in the study Exclusion Criteria: * Amputees * Those who cannot communicate adequately * Having a neurological or orthopedic problem that will affect functionality * Those who cannot walk independently * Those who underwent surgery * Those with endoprosthesis **Healthy Volunteers:** True **Maximum Age:** 75 Years **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### 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:** NCT06441383 **Acronym:** SANDMAN **Brief Title:** Assessment of Sleep Disordersin People Living With HIV in the Era of New Antiretroviral Therapies in North of France. **Official Title:** Assessment of Sleep Disordersin People Living With HIV in the Era of New Antiretroviral Therapies in North of France. #### Organization Study ID Info **ID:** CHT/URC/2023/11 #### Organization **Class:** OTHER **Full Name:** Tourcoing Hospital ### Status Module #### Completion Date **Date:** 2025-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-28 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Tourcoing 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:** People living with HIV (PLHIV) appear to present with sleep-related complaints more frequently than the general population, with a prevalence of 50-70%. The latest French multi-center epidemiological data are dated. The prevalence of the different types of sleep disorders, however, is poorly documented, with the literature focusing mainly on insomnia and neuropsychological disorders that can lead to sleep disorder-like symptoms, and on the impact of antiretroviral drugs in particular. However, there are other sleep disorders such as sleep apnea syndrome (SAHOS) or restless legs syndrome. SAHOS has been studied in small series of patients. This multicenter, cross-sectional study will identify and update the functional complaints presented by PLHIV, estimate the prevalence of people at high risk of sleep apnea syndrome, and study the associated socio-demographic factors, in relation to HIV infection and antiretrovirals. This study could open up avenues for new management approaches and earlier detection of sleep disorders. ### Conditions Module **Conditions:** - HIV Infections - Sleep Disorder ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 1100 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** The the Pittsburg Sleep Quality Index (PSQI) questionnaire is a standardized tool for the subjective assessment of sleep. Sleep is described according to 7 components: subjective sleep quality, sleep onset latency, sleep duration, sleep efficiency, sleep disorders, medication use and daytime dysfunction. The sum of the scores for these 7 components gives an overall score of 21 points maximum. The presence of sleep disorders will be defined according to the results of the PSQI, with a value above 5 defining the presence of sleep disorders. **Name:** Pittsburgh Sleep Quality Index **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The presence of sleep disorders will be defined according to the results of the Pittsburg Sleep Quality Index (PSQI), with a value greater than 5 defining the presence of sleep disorders. **Measure:** Prevalence of sleep disorders **Time Frame:** at baseline #### Secondary Outcomes **Description:** The Berlin score defines the signs suggestive of Obstructive Sleep Apnea-Hypopnea Syndrome. A score ≥ 2 positive categories will define a high risk of Obstructive Sleep Apnea-Hypopnea Syndrome **Measure:** Prevalence of Obstructive Sleep Apnea-Hypopnea Syndrome **Time Frame:** at baseline **Description:** The International Restless Legs Syndrome (RLS) Severity Scale will identify patients with symptoms in favor of RLS. **Measure:** Prevalence of Restless Legs Syndrome **Time Frame:** at baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * PLHIV usually treated at referral centers in northern France. Exclusion Criteria: * Minor patient; * Patient with insufficient understanding of the French language, as judged by the investigator; * Patient unable to give free and informed consent; * Refusal to participate; * Patient under legal protection, guardianship or curatorship; * Pregnant and breast-feeding women. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The target population is all adults living with HIV. The study will be offered to all PLHIV at the time of their annual specialist consultation with their infectiologist in the referring hospital centers in northern France. ### Contacts Locations Module #### Locations **Location 1:** **City:** Tourcoing **Country:** France **Facility:** CH Tourcoing ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009422 - Term: Nervous System Diseases - ID: D000009461 - Term: Neurologic Manifestations - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M18250 - Name: HIV 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: M22242 - Name: Parasomnias - Relevance: LOW - As Found: Unknown - ID: M3522 - Name: Acquired Immunodeficiency Syndrome - Relevance: LOW - As Found: Unknown - ID: M15696 - Name: Sleep Wake Disorders - Relevance: HIGH - As Found: Sleep Disorders - ID: M12404 - Name: Neurologic Manifestations - 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: D000012893 - Term: Sleep Wake Disorders ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - 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:** NCT06441370 **Acronym:** AQUAMODA **Brief Title:** Patient Satisfaction During Physiological Water or Land Birth: a Prospective Study in an French Tertiary Maternity Unit. **Official Title:** Patient Satisfaction With Physiological Childbirth in Water or on Land a Prospective Study at the Tourcoing Hospital Maternity Unit #### Organization Study ID Info **ID:** 22.01415.000084 #### Organization **Class:** OTHER **Full Name:** Tourcoing Hospital ### Status Module #### Completion Date **Date:** 2026-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-04-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-28 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Tourcoing 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:** A study will be carried out to compare the level of satisfaction and psychological state of women who give birth in water with those who give birth out of water. The aim is to demonstrate the benefits of water birth and justify its place in the healthcare offering. ### Conditions Module **Conditions:** - Water Birth ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 1200 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Procedure: waterbirth **Label:** women with water births #### Arm Group 2 **Label:** women giving birth on land ### Interventions #### Intervention 1 **Arm Group Labels:** - women with water births **Description:** waterbirth: laboured for all or part of the first stage of labour and remained in the water for birth of newborn **Name:** waterbirth **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The "perception of control over childbirth" dimension of the QEVA (Quality and Experience of Childbirth), a long version with a total of 6 dimensions. The score associated with the "perception of control over childbirth" dimension is obtained by averaging responses to items 8, 10, 11, 12, 14 and 18 of the questionnaire. The response to each of these items is coded on a Likert scale from 1 to 4, with a high value corresponding to poor control. **Measure:** Perceived control over childbirth **Time Frame:** This questionnaire will be achieved by participating women within 3 days postpartum, before discharge from the maternity ward. #### Secondary Outcomes **Description:** The scores associated with the 5 other dimensions of the QEVA questionnaire: * Expectations, defined by items 9, 15 and 20; * Sensory experience, defined by items 3 and 16; * Relationship with caregivers, defined by items 5, 6, 7 and 13; * Emotions, defined by items 1, 2, 4, 21, 22, 23 and 24; * First moments with baby, defined by items 17, 18 and 19; Answers to the questions are coded on Likert scales from 1 to 4. Each score is calculated by averaging the responses to the questions in the dimension in question. **Measure:** Dimension of the quality and experience of childbirth within 3 days of delivery **Time Frame:** This questionnaire is to be completed within 3 days of delivery, before discharge from the maternity hospital. **Description:** The scores associated with the 5 other dimensions of the QEVA questionnaire: * Expectations, defined by items 9, 15 and 20; * Sensory experience, defined by items 3 and 16; * Relationship with caregivers, defined by items 5, 6, 7 and 13; * Emotions, defined by items 1, 2, 4, 21, 22, 23 and 24; * First moments with baby, defined by items 17, 18 and 19; Answers to the questions are coded on Likert scales from 1 to 4. Each score is calculated by averaging the responses to the questions in the dimension in question. **Measure:** Dimension of the quality and experience of childbirth within 2 months of delivery **Time Frame:** This questionnaire is to be completed within 2 months of delivery. **Description:** The Edinburgh Postnatal Depression Scale (EPDS) will be used to assess anxiety and depression and depression at 2 months postpartum in order to screen for possible postpartum depression. **Measure:** Anxiety and depression at 2 months of delivery. **Time Frame:** This questionnaire is to be completed within 2 months of delivery. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Major patient * Social security beneficiary * Presence of a companion * Delivery greater than or equal to 37 weeks of amenorhoea * Spontaneous labor * Cephalic presentation * Physiological delivery by woman's choice according to 2017 HAS criteria (French recommendations) Exclusion Criteria: * Patient under court protection * Patient under guardianship or curatorship * Placement of an epidural * Language barrier * Unexpected delivery (unwanted by the woman) * Scarred uterus * Meconium fluid * Maternal pathologies: epilepsy, MS (depending on neurological opinion), diabetes (types 1 and 2), herpes infection, HIV, HBV, HCV * History of delivery hemorrhage \> 1L * History of shoulder dystocia/clavicle fracture * Metrorrhagia * Administration of nalbuphine within 2 hours of birth. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** All patients who have chosen to give birth physiologically at the Maternity unit will be offered the study during their maternity stay. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Vitagliano JV Jean-Jacques, PhD **Phone:** 03.20.69.42.80 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Degrendel MD Maxime, MD **Phone:** 03.20.69.42.80 **Role:** CONTACT #### Locations **Location 1:** **City:** Tourcoing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Vitagliano JV Jean_Jacques, PhD - **Phone:** 03.20.69.42.80 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Degrendel MD Maxime, MD - **Phone:** 03.20.69.42.80 - **Role:** CONTACT **Country:** France **Facility:** Tourcoing Hospital **State:** Hauts De France **Status:** RECRUITING **Zip:** 59200 #### Overall Officials **Official 1:** **Affiliation:** Tourcoing Hospital **Name:** GOBERT JG julia, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Tourcoing Hospital **Name:** GAILLARD JG Julie **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:** NCT06441357 **Brief Title:** Differentiating the Invasiveness of Lung Adenocarcinoma by Dual Energy CT Parameter **Official Title:** Differentiating the Invasiveness of Lung Adenocarcinoma by Dual Energy CT Using Extracellular Volume Measured in Delay Phase #### Organization Study ID Info **ID:** TDFS20240328 #### Organization **Class:** OTHER **Full Name:** Tang-Du Hospital ### Status Module #### Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-12-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-28 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Tang-Du Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The core purpose of this study is to investigate whether the extracellular volume (ECV) fraction measured in delay phase by dual energy computed tomography (DECT) can distinguish precancerous lesions from early-stage lung adenocarcinomas, which could assist clinical decision making for surgery operation indication and strategy. **Detailed Description:** Although progression of lung adenocarcinoma (LUAD) depends on driver mutations, it is also affected by tumor microenvironment (TME), including vessels, immune cells and extracellular matrix (ECM). As major constituent of TME, ECM mediates interactions between cancer cells and stromal cells, promotes angiogenesis, epithelial-mesenchymal transition, causes metastasis and resistance to immune therapy. Along with the progression of LUAD histologic stages, from atypical adenomatous hyperplasia (AAH) and adenocarcinoma in situ (AIS) to minimally invasive adenocarcinoma (MIA), and finally to invasive adenocarcinoma (IA), the composition of the ECM changes a lot, which has some characterizations same as interstitial pulmonary fibrosis. Hence, identifying the pathological ECM status may help differentiating the invasiveness of lung adenocarcinomas. Based on the theory that in delay phase, the contrast medium is evenly distributed in the intravascular and extravascular-extracellular spaces and not entering the cell, extracellular volume (ECV) fraction is considered as a potential quantitative imaging parameter for ECM. It has been confirmed that ECV fraction is highly consistent with pathological fibrosis in cardiac and hepatic diseases. In other lesions with fibrosis such as pancreatic and thymic epithelial tumors, ECV fraction also has positive effects in malignancy prediction. It has been verified that ECV fraction is capable of differentiating lung cancer with benign lung lesions and classifying lung cancers into three subtypes. However, there has yet no study testified it as an invasion predictor. The core purpose of this study is to investigate whether ECV fraction can distinguish precancerous lesions from early-stage lung adenocarcinomas and compare it with other confirmed radiological features in prediction performance, which is clinically meaningful regarding optimal treatment selection and avoidance of unnecessary surgical procedures. ### Conditions Module **Conditions:** - Adenocarcinoma of Lung **Keywords:** - ECV, invasion, lung adenocarcinoma, DECT ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 2000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** preinvasive lung adenocarcinomas include atypical adenomatous hyperplasia (AAH), adenocarcinoma in situ (AIS) and minimally invasive adenocarcinoma (MIA) **Label:** Patients with preinvasive lung adenocarcinomas #### Arm Group 2 **Description:** invasive adenocarcinoma(IAC) **Label:** Patients with invasive lung adenocarcinomas ### Outcomes Module #### Other Outcomes **Description:** Including consolidation tumor ratio (CTR), nodule's maximum diameter, spiculation, lobulation, fibrosis, distortion or cut-off of vessels and bronchi. **Measure:** Acquire relative radiological features. **Time Frame:** 2 years #### Primary Outcomes **Description:** Including iodine concentration (IC) in delay phase, normalized IC (NIC), effective atomic number (Zeff), and CT attenuation values of nodules from virtual monochromatic images (VMIs) (energy range from 40 to 150 keV, 10keV as interval). **Measure:** Acquire DECT parameters in patients with pulmonary nodules. **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients older than 18 years old with pulmonary nodules (diameter≤3 cm). * pathologically confirmed as lung adenocarcinoma. * without history of other malignancies. * accurate hematocrit within 1 week before contrast enhanced dual energy CT examination. Exclusion Criteria: * with a history of allergy to iodine contrast agents and other reasons who are unable to complete the examination. * without histopathology of invasion stage, such as AAH, AIS, MIA and IAC. * history of chemotherapy, radiotherapy, or other anti-tumor therapy before contrast enhanced dual energy CT. * poor image quality. * contrast enhanced dual energy CT scans ≥ 4 weeks before surgery. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with pulmonary nodules who intend to have contrast enhanced CT in Tangdu hospital. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Cui Guangbin, Professor **Phone:** 18992898517 **Role:** CONTACT #### Locations **Location 1:** **City:** Xi'an **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Cui Guangbin, Professor - **Phone:** 18992898517 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Jiang Nan - **Phone:** 18093701139 - **Role:** CONTACT **Country:** China **Facility:** Tangdu Hospital **State:** Shaanxi **Status:** RECRUITING **Zip:** 710038 #### Overall Officials **Official 1:** **Affiliation:** ang-Du Hospital **Name:** Cui Guangbin **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000008175 - Term: Lung Neoplasms - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M3585 - Name: Adenocarcinoma - Relevance: HIGH - As Found: Adenocarcinoma - ID: M1687 - Name: Adenocarcinoma of Lung - Relevance: HIGH - As Found: Adenocarcinoma of Lung - ID: M5534 - Name: Carcinoma - 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: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: T3520 - Name: Lung Adenocarcinoma - Relevance: HIGH - As Found: Lung Adenocarcinoma ### Condition Browse Module - Meshes - ID: D000000230 - Term: Adenocarcinoma - ID: D000077192 - Term: Adenocarcinoma of Lung ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441344 **Acronym:** SCLC **Brief Title:** Toripalimab Plus Anlotinib for the Maintenance of Extensive Stage Small Cell **Official Title:** First-line Etoposide Combined With Platinum-based Chemotherapy Followed by Toripalimab Plus Anlotinib for the Maintenance of Extensive Stage Small Cell Carcinoma - A Randomized, Controlled, Multicenter Phase III Clinical Study #### Organization Study ID Info **ID:** SCLC-maintaine #### Organization **Class:** OTHER **Full Name:** Taizhou Hospital ### Status Module #### Completion Date **Date:** 2030-05-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-03-19 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Taizhou Hospital #### Responsible Party **Investigator Affiliation:** Taizhou Hospital **Investigator Full Name:** Dongqing Lv, MD **Investigator Title:** Chief medical officer **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a randomized, open, multicenter Phase III clinical study. A total of 136 participants are planned to be enrolled and randomly assigned to either the experimental group (platinum+etoposide → toripalimab plus anlotinib) or the control group (platinum+etoposide+ toripalimab → toripalimab) in a 1:1 ratio. The primary efficacy measures include PFS, while secondary endpoints include OS, DOR, ORR, DCR, progression free survival at 6 and 12 months, overall survival at 12 and 18 months, health-related quality of life (FACT-L), safety, etc. And in the III clinical study, tissue samples were collected before treatment, and tumor tissue and blood samples were taken from some patients after 3 cycles of maintenance treatment and treatment progression for single-cell sequencing and transcriptome sequencing to verify the underlying mechanism research **Detailed Description:** This study plans to enroll 136 subjects and randomly allocate them in a 1:1 ratio to the experimental group (platinum+etoposide → toripalimab plus anlotinib) and the control group (platinum+etoposide+ toripalimab → toripalimab). The experimental group was given etoposide (100 mg/m2) d1-3+carboplatin (AUC 5 d1)/cisplatin (25 mg/m2 D1-3) chemotherapy regimen, for patients who have received 4-6 cycles chemotherapy sessions (including PR, CR, SD), they will enter the maintenance treatment phase and receive an oral dose of 12 mg of anlotinib ( on days 1-14) combined with 240 mg toripalimab for maintenance treatment; The control group was given etoposide (100 mg/m2) d1-3+carboplatin (AUC 5) d1/cisplatin (25mg/m2) d1+toripalimab 240 mg d1 (including PR, CR, SD) who have been treated 4-6 cycles will enter the maintenance treatment period, and receive maintenance treatment with toripalimab 240 mg d1 . The above treatment regimen lasts for 21 days per cycle until disease progression or Intolerable adverse reactions occur or researchers believe that patients are not suitable for continued medication. After the subject terminates or withdraws from this study, the researcher may adopt reasonable follow-up treatment based on the subject's condition. All patients will be followed up until death or the deadline for data collection. Collect pathological tissue samples before treatment for genetic testing. Before using maintenance therapy medication, after 1 cycle of maintenance therapy and during progression, after 3 cycles of treatment, some patients are selected for puncture biopsy sampling after treatment progression Perform sequencing and biomarker inspection. Follow up on PFS, OS, ORR, DCR, adverse reactions, etc. in two groups of patients. Before maintenance therapy, researchers are allowed to perform local radiotherapy based on the patient's actual situation, such as cranial radiotherapy, bone metastasis radiotherapy, etc., but radiotherapy for the target lesion is not allowed. However, additional treatments related to tumors, including traditional Chinese medicine and radiation therapy, are not allowed during the maintenance treatment process. The primary endpoints of this study were objective progression free survival (PFS) and overall survival (OS) evaluated according to the RECIST v1.1 criteria, while secondary endpoints were duration of response (DOR), overall objective response rate (ORR), disease control rate (DCR)and safety. ### Conditions Module **Conditions:** - SCLC - Maintenance Treatment **Keywords:** - ES-SCLC - Maintenance Treatment - Toripalimab - Anlotinib ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 136 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The experimental group was given etoposide (100 mg/m2) d1-3+carboplatin (AUC 5 d1)/cisplatin (25 mg/m2)d1-3 Chemotherapy regimen, for patients who have received 4-6 cycles chemotherapy sessions (including PR, CR, SD), they will enter the maintenance treatment phase and receive an oral dose of 12 mg of anlotinib (d1-14) combined with intravenous infusion of toripalimab 240mg for maintenance treatment until progress or intolerable adverse reactions occur or died for other illnesses **Intervention Names:** - Drug: Toripalimab plus Anlotinib **Label:** platinum+etoposide → toripalimab plus anlotinib **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The control group was given etoposide (100 mg/m2) d1-3+carboplatin (AUC 5) d1/cisplatin (25mg/m2)+and toripalimab (240 mg) ,for patients who have received 4-6 cycles chemotherapy sessions (including PR, CR, SD), they will enter the maintenance treatment phase and receive maintenance treatment with toripalimab 240 mg d1 until progress or intolerable adverse reactions occur or died for other illnesses **Intervention Names:** - Drug: Toripalimab **Label:** platinum+etoposide+ toripalimab → toripalimab **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - platinum+etoposide → toripalimab plus anlotinib **Description:** For patients who did not progress after standard chemotherapy, toripalimab plus anlotinib maintenance therapy was used **Name:** Toripalimab plus Anlotinib **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - platinum+etoposide+ toripalimab → toripalimab **Description:** For patients who did not progress after standard chemotherapy+toripalimab, toripalimab maintenance therapy was used **Name:** Toripalimab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The time from the start of randomization until the first occurrence of disease. progression or death from any cause, whichever occurs first. **Measure:** progression free survival(PFS) **Time Frame:** 5 years from first patient randomized **Description:** The time from randomization to death from any cause **Measure:** overal survival time(OS) **Time Frame:** 5 years from first patient randomized #### Secondary Outcomes **Description:** The type, frequency, severity, and degree of treatment-related adverse events (according to CTCAE version 5.0) **Measure:** Adverse events **Time Frame:** Duration of time from the start of treatment to the end of study, assessed up to 5 years **Description:** The proportion of patients with a complete or partial response **Measure:** objective response rate(ORR) **Time Frame:** Duration of time from the start of treatment to the end of study, assessed up to 5 years **Description:** the proportion of patients with a complete response, partial response, or stable disease **Measure:** Disease control rate(DCR) **Time Frame:** Duration of time from the start of treatment to the end of study, assessed up to 5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or female aged ≥ 18 and\<80 years old. * The ECOG score is 0-1 points (including 0 and 1 points), and the expected survival period is not less than 3 months. * Confirmed as small cell lung cancer (SCLC) by histopathology or cytology and diagnosed as extensive after systemic evaluation. * I have not received first-line treatment for ES-SCLC systemic chemotherapy or immune checkpoint inhibitors in the past. * Limited stage SCLC progresses to extensive stage SCLC after receiving previous radiotherapy and chemotherapy aimed at cure,at least 6 months of no treatment period is required after the last radiotherapy and/or chemotherapy treatment. * Patients with previous active brain metastases have stabilized after treatment and do not require immediate or planned brain intervention during the study period Transfer for local treatment. * According to the criteria for evaluating the efficacy of solid tumors (RECIST v1.1), enrolled patients should have at least one tumor throughout their body The tumor lesion can meet the following requirements: it has not undergone local treatment such as radiotherapy in the past and is at baseline Can be accurately measured, with a baseline maximum diameter of ≥ 10mm (if it is a lymph node, a minimum diameter of ≥ 15mm is required). Lesions that have previously received local treatment (radiotherapy or other treatments), if the treatment is completed for at least 6 months If disease progression occurs later, the lesion in the area that has undergone local treatment can be considered a measurable lesion. * Patients should have sufficient bone marrow reserve function and no liver, kidney, or coagulation dysfunction, and laboratory tests should be conducted * The value must meet the following conditions: 1. Absolute neutrophil count ≥ 1.5 × 109/L, and white blood cell count ≥ 3 × 109/L; 2. Platelet count ≥ 100 × 109/L; 3. Hemoglobin ≥ 90g/L; 4. Serum creatinine (Cr) ≤ 1.5 x Upper limit of normal (ULN) or creatinine clearance rate (CrCl) ≥ 50ml/min (for patients with serum creatinine\>1.5 x ULN); 5. If there is no confirmed liver metastasis, AST and ALT ≤ 2.5 × ULN; If there is confirmed liver metastasis, AST,ALT ≤ 5 × ULN; 6. If there is no confirmed liver metastasis, total bilirubin ≤ 1.5 × ULN; If there is confirmed liver metastasis or patients with syndrome (high indirect bilirubinemia), total bilirubin ≤ 3 x ULN; 7. If there is no confirmed liver metastasis, alkaline phosphatase (ALP) ≤ 2.5 x ULN or ≤ 5 x ULN (bone metastasis) 8. Albumin (ALB)\>30g/dl; 9. 24-hour urine protein quantification\<1g (if urine protein ≥ 2+, additional 24-hour urine protein testing is required) 10. Serum lipase or amylase ≤ 1.5 x ULN or\>1.5 x ULN (clinical or imaging diagnosis of pancreas) 11. International standardized ratio (INR) ≤ 1.5, and activated partial prothrombin time (APTT)≤ 1.5 x ULN. * Female subjects with reproductive ability have a negative blood pregnancy result within 7 days before starting the study treatment, and are willing to From the time of signing the informed consent form until the end of the last medication use, abstain from sexual activity or take medication for a period of 6 months medically recognized and efficient contraceptive measures (such as intrauterine devices, condoms, etc.), but the use of hormones is prohibited Using similar drugs for contraception; Male subjects are willing to take informed consent from the time of signing until the end of the last medication use Within the next 6 months, abstain from sexual activity or use medically recognized and effective contraceptive measures (such as condoms),and during this period, no sperm will be donated;. * The subjects are able to understand and voluntarily sign a written informed consent form (the informed consent form must be completed before conducting the study) Sign before any program specified in the plan. * Be able to voluntarily complete the research procedures and follow-up examinations according to the requirements of the research protocol. Exclusion Criteria: * Mixed small cell lung cancer diagnosed by histology or cytology; * A history of severe allergic diseases, severe drug (including unmarketed investigational drugs) allergies, or known adverse reactions to this medication Allergy to any component of the investigational drug: presence of etoposide, platinum based drugs (carboplatin/cisplatin), or anlotinib.Individuals who are contraindicated to the use of anlotide or Toripalimab; * Previously received treatment with immune checkpoint agonists (such as CD137 agonists) or immune checkpoint inhibitors.Preparation therapy (such as single/dual antibodies against CTLA-4, PD-1, PD-L1, LAG3, etc.) or anti VEGF targeted drugs; * Previously received curative radiotherapy (excluding those who met the inclusion criteria of 5), or before receiving study treatment.Has undergone extensive palliative radiotherapy within 4 weeks, or plans to undergo chest radiotherapy during the study period * Need or plan to undergo elective surgical treatment during the trial period; * Received the following treatments or medications before starting the research treatment: 1. Received important organ surgery (excluding puncture) within 28 days before starting the study and treatment Inspection; 2. Received attenuated live vaccine within 28 days prior to starting treatment; 3. Have used intravenous broad-spectrum antibiotics for at least 7 days within 14 days before starting the study treatment; 4. Starting the study on systemic corticosteroids (prednisone\>10) received within 14 days prior to treatment Mg/day or equivalent dose of similar drugs or other immunosuppressive treatments; Except for the following situations External: Treatment with local, ocular, intra-articular, intranasal, and inhaled corticosteroids; short Regular use of glucocorticoids for preventive treatment (such as preventing contrast agent allergies); 5. Received palliative radiotherapy for bone metastases within 14 days prior to starting the study treatment; * Currently, there is spinal cord compression or superior vena cava syndrome; * Currently, there are clear cases of interstitial lung disease or non infectious pneumonia, except for those caused by local radiotherapy; * There are brain metastases in the midbrain, pons, medulla oblongata, spinal cord, meninges, and meninges, or symptomatic large brain metastases Brain or cerebellar metastasis (such as manifested as cerebral edema and/or progressive growth); Central nervous system conversion Individuals limited to the brain and cerebellum can participate in screening if they meet the following conditions: a. Asymptomatic brain metastases (asymptomatic central nervous system progressive symptoms caused by brain metastases, also not necessary) Using corticosteroids or antiepileptic drugs for treatment; b. Symptoms stabilize for at least 2 weeks after radiotherapy for brain metastases, and corticosteroids or antiepileptic drugs are discontinued Drug discontinuation for at least 2 weeks; * Evidence of significant coagulation disorders or other significant bleeding risks: 1. History of intracranial hemorrhage or spinal cord hemorrhage; 2. Patients with tumor lesions invading large blood vessels and having a significant risk of bleeding; 3. Within the 6 months prior to the start of the study treatment, there have been incidents of thrombosis or embolism (asymptomatic and none) Except for intramuscular venous thrombosis that requires treatment, there is no absorption during follow-up examination, or significant vascular disease is present (For aortic aneurysm, aortic dissection, etc. that require surgical repair); 4. Clinically significant hemoptysis or tumor development for any reason within the first 3 months prior to starting the study treatment Blood; 5. Within 14 days prior to the start of the study, use anticoagulant therapy for therapeutic purposes (with low prophylactic use) Excluding molecular weight heparin; * Past or current active autoimmune diseases or immunodeficiency, including but not limited to severe muscle disease Weakness, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammation Sexually transmitted bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sj ö gren syndrome, Grimm Barr syndrome Li syndrome or multiple sclerosis; Except for: a Autoimmune related hypothyroidism Subjects with a history of withdrawal and currently taking thyroid replacement hormone; b. Stable status receiving insulin treatment 30% of subjects with type I diabetes. * Lesions limited to subjects with eczema, psoriasis, chronic simple lichen, and vitiligo on the skin (if diseased) When the damage has already affected parts or organs outside the skin (such as psoriasis, arthritis, etc.), it cannot be included in the group: i. Fever of unknown origin\>38.5 ℃ (fever caused by tumor can be included in the group); * Within 6 months prior to starting the study of drug therapy, the following situations occurred: 1. Suffering from congestive heart failure, severe/unstable angina, cerebrovascular accident, New York, USA Cardiac insufficiency classified by the Society of Cardiology (NYHA) as Grade II or above (including Grade II), Or other structural heart diseases that have been determined by researchers to be at high risk; 2. History of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or abdominal abscess; 3. There is uncontrollable tumor related pain, and if painkillers are needed, they should be stable during screening A prescribed pain relief treatment plan; Asymptomatic metastatic lesions, if further grown, may lead to Causing functional impairment or stubborn pain (such as epidural metastases that are currently unrelated to spinal cord compression), If appropriate, local treatment should be considered before screening; * Within the 5 years prior to starting the research on drug therapy, if there were other active malignant tumors, local treatment may be necessary Except for malignant tumors that have been treated and cured (such as basal cell or squamous cell carcinoma of the skin, superficial or non malignant) Invasive bladder cancer cancer, cervical carcinoma in situ, breast intraductal carcinoma in situ, thyroid papillary carcinoma); * Individuals who have received allogeneic hematopoietic stem cell transplantation or organ transplantation in the past; * Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); * Syphilis antibody positive and active syphilis infection present; * Individuals with active pulmonary tuberculosis or a history of pulmonary tuberculosis infection that cannot be controlled after treatment; * 20 HBsAg or HBcAb positive, and HBV-DNA\>2000 IU/mL (for For patients with HBV DNA\>500 IU/mL, the subject must agree to at least 7 days prior to the start of the study drug Continuously receiving antiviral treatment other than interferon during the research period is necessary to participate in screening; HCV antibodies Positive and HCV-RNA higher than the lower limit of detection in the experimental center (if the center is unable to detect HCV) RNA, acceptable external hospital results, relevant reports should be provided); * Expected to receive any other form of anti-tumor drug treatment during the trial period; * Known to have a history of alcohol abuse, psychotropic substance abuse, or drug use; * Individuals with mental disorders or poor compliance; * Pregnant or lactating women * According to the judgment of the researchers, the basic condition of the subjects may increase their risk of receiving study drug treatment,Or confusion caused by the occurrence of toxic reactions and the explanation of AE; * Other researchers deemed it unsuitable to participate in this experiment; **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:** Dongqing Lv, Dr. **Phone:** 13867622009 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M28323 - Name: Small Cell Lung Carcinoma - Relevance: LOW - As Found: Unknown - ID: M20433 - Name: Carcinoma, Small Cell - Relevance: LOW - As Found: Unknown - ID: T5271 - Name: Small Cell Lung Cancer - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M6182 - Name: Cisplatin - Relevance: LOW - As Found: Unknown - ID: M18650 - Name: Carboplatin - Relevance: LOW - As Found: Unknown - ID: M8191 - Name: Etoposide - Relevance: LOW - As Found: Unknown - ID: M341643 - Name: Etoposide phosphate - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441331 **Acronym:** KinLET **Brief Title:** Phase I Trial to Determine the Dose and Evaluate the PK of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors **Official Title:** A Multicenter, Open-label, Interventional Phase I Trial to Determine the Dose and Evaluate the Pharmacokinetics (PK) and Safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as Monotherapy or Following Standard of Care (SoC) for the Treatment of Somatostatin Receptor-positive Tumors in the Pediatric Population (KinLET). #### Organization Study ID Info **ID:** ITM-1191-01 #### Organization **Class:** INDUSTRY **Full Name:** ITM Solucin GmbH ### Status Module #### Completion Date **Date:** 2034-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** ITM Solucin 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:** The purpose of the study is to determine the appropriate pediatric dosage and evaluate the pharmacokinetics (PK) and safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as a monotherapy or following standard of care (SoC) in participants ≥2 to \<18 years of age with somatostatin receptor (SSTR)-positive tumors. **Detailed Description:** Determine the dose, pharmacokinetics and safety of Lutetium Lu 177 Edotreotide as monotherapy or following sequential standard of care in pediatric participants with recurrent, progressive or refractory NET, CNS, lymphoma and other solid tumors that express SSTRs by immunohistochemistry and demonstrate uptake by somatostatin receptor imaging. Lutetium Lu 177 Edotreotide will be given intravenously once every 8 weeks for a total of up to 6 doses over an average of 48 weeks in participants aged 2-18 years. ### Conditions Module **Conditions:** - NET - Lymphoma - Solid Tumor, Childhood - Somatostatin Receptor Positive - CNS Tumor **Keywords:** - Pediatric - CNS tumors - Solid tumors - Lymphoma - Somatostatin Receptor (SSTR)-positive Tumors - Lutetium Lu 177 Edotreotide - Targeted RPT - ITM - GEP-NET - Neuroendocrine tumors - Radiopharmaceutical Therapy ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Three sequential age cohorts: 1. ≥ 12 to \< 18 years old 2. ≥ 6 years to \< 12 years old 3. ≥ 2 to \< 6 years old A minimum of 20 participants with SSTR-positive tumors of which at least six participants will have gastroenteropancreatic neuroendocrine tumors (GEP-NETs). A minimum of six participants will be required in each age cohort. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Arms are based upon age at enrollment. The opening of the 2nd and 3rd cohort will depend on the recruitment of at least four participants with dosimetry and safety data for cycle 1, in the previous cohort. 1. ≥ 12 to \< 18 years old 2. ≥ 6 years to \< 12 years old 3. ≥ 2 to \< 6 years old **Intervention Names:** - Drug: Lutetium Lu 177-Edotreotide - Other: Amino Acid Solution **Label:** Three sequential age cohorts **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Three sequential age cohorts **Description:** lutetium Lu 177 edotreotide At least two cycles and a maximum of six cycles at eight-week (± 2 we-ek) intervals. Extrapolation from standard maximum adult dose of 100 Megabecquerel(MBq)/kg for a 75 kg adult for the first cohort. Dosing decision for the subsequent cohorts by Data Monitoring Committee (DMC), based on (at least) cycle 1 dosimetry and safety data from at least four participants of the preceding cohort. Route of administration: Intravenous (IV) infusion. Duration of treatment: 16-48 weeks **Name:** Lutetium Lu 177-Edotreotide **Other Names:** - 177Lu-edotreotide **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Three sequential age cohorts **Description:** The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution. **Name:** Amino Acid Solution **Other Names:** - Arginine-Lysine Solution **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Safety evaluation of Lutetium Lu 177 edotreotide targeted RPT as monotherapy or following standard of care **Measure:** Rate of adverse events **Time Frame:** From treatment start until 4 weeks after End of Last Treatment. **Description:** Additional preliminary efficacy evaluation of lutetium Lu 177 Edotreotide targeted RPT as monotherapy or following SoC **Measure:** Overall Survival, Progression-Free Survival and Duration of Response **Time Frame:** Every 9 ± 3 weeks from enrollment until disease progression or for up to two years, whichever came first. #### Primary Outcomes **Description:** Progression-Free Survival is monitored by anatomical/functional imaging. **Measure:** Progression-Free Survival **Time Frame:** Morphological/functional imaging (9 ± 3 weeks of 1st RPT,repeated 9 ± 3 weeks up to 2 years after End of Last Treatment Visit, or disease progression. Progression-Free Survival Follow Up is discontinued, then simple Follow-up for five years. #### Secondary Outcomes **Description:** Assess preliminary anti-tumor activity by tumor type **Measure:** Objective Response Rate **Time Frame:** At the end of Cycle 2 (each cycle is 28 days) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participants aged ≥ 24 months and \< 18 years * Confirmed diagnosis somatostatin receptor-positive (SSTR-positive) disease. * Tumor which is relapsed or is refractory to at least one line of previous therapy * Positive SSTR protein expression confirmed by immunohistochemistry of a tumor histology sample * Radioactivity uptake within the primary tumor or metastatic tumor sites measured by locally available SRIs ( 111In-based, 99mTc-based, or 68Ga-based SSTR single-photon emission computed tomography (SPECT)/ computed tomography (CT) or positron emission tomography (PET)/CT imaging, which is higher than the liver uptake) * Participants must have recovered from the acute treatment related toxicities (defined as ≤ grade 1 if not defined in eligibility criteria, excluding alopecia, stable treated electrolyte abnormalities on replacement and stable treated hypothyroidism) of all prior treatment modality prior to entering this trial * In case of sequential treatment followed by SoC or prior therapy, washout period applies before starting targeted RPT Screening Consent Participant/legal guardian is willing to sign a screening consent. The screening consent is to be obtained according to institutional guidelines. Assent, when appropriate, will be obtained according to institutional guidelines. Exclusion Criteria: * Known hypersensitivity to Lutetium Lu 177 Edotreotide, DOTA/Edotreotide, or excipients * Previous history of acute leukemia unless in remission for at least two years * Extensive bone/bone marrow involvement as per Investigator's judgement unless peripheral blood stem cells (PBSC) are available at a minimum of 2.5x106 CD34+ cells/kg * Patients who have received previous systemic targeted RPT * Previous treatment with metaiodobenzyl guanidine (MIBG) if the predicted overall exposure is expected to exceed 2 Gy (gray) to the bone marrow or 23 Gy to the kidney. * Previous treatment with external beam radiation therapy (EBRT) if the predicted overall exposure is expected to exceed more than 2 Gy to the bone marrow or 23 Gy to the kidney. * Previous treatment with oncologic immune vaccine or CAR-T cell therapy * Bulky disease in the CNS * Presence of severe renal, hepatic, electrolyte, cardiovascular, or hematological dysfunction * Participants who have received a live-attenuated vaccine up to four weeks prior to enrolment * Pregnant or breastfeeding women. * Other known malignancies. * Serious non-malignant disease. **Maximum Age:** 18 Years **Minimum Age:** 24 Months **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Shahanaz Rahman **Phone:** 089 32989866000 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Serhii Melnyk, PhD **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Director Clinical Operations and Alliance Management **Name:** Nicolas Schneider, PhD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009423 - Term: Nervous System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11220 - Name: Lymphoma - Relevance: LOW - As Found: Unknown - ID: M18937 - Name: Central Nervous System Neoplasms - Relevance: HIGH - As Found: CNS Tumors - ID: M20495 - Name: Neuroendocrine Tumors - Relevance: LOW - As Found: Unknown - ID: M12367 - Name: Nervous System Neoplasms - Relevance: LOW - As Found: Unknown - ID: T3543 - Name: Lymphosarcoma - Relevance: LOW - As Found: Unknown - ID: T4091 - Name: Neuroendocrine Tumor - Relevance: LOW - As Found: Unknown - ID: T2442 - Name: Gastro-enteropancreatic Neuroendocrine Tumor - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms - ID: D000016543 - Term: Central Nervous System Neoplasms ### Intervention Browse Module - Ancestors - ID: D000019275 - Term: Radiopharmaceuticals - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000005765 - Term: Gastrointestinal Agents - ID: D000018931 - Term: Antineoplastic Agents, Hormonal - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: HIGH - As Found: Procedure - ID: M211320 - Name: Edotreotide - Relevance: HIGH - As Found: Systemic Inflammatory Response Syndrome - ID: M254743 - Name: Edotreotide lutetium LU-177 - Relevance: HIGH - As Found: Flowering - ID: M15806 - Name: Somatostatin - Relevance: LOW - As Found: Unknown - ID: M21258 - Name: Radiopharmaceuticals - Relevance: LOW - As Found: Unknown - ID: M17982 - Name: Octreotide - Relevance: HIGH - As Found: Systemic Inflammatory Response Syndrome - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown - ID: M20966 - Name: Antineoplastic Agents, Hormonal - Relevance: LOW - As Found: Unknown - ID: T1 - Name: Arginine - Relevance: HIGH - As Found: Every 21 days - ID: T11 - Name: Lysine - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000015282 - Term: Octreotide - ID: D000019999 - Term: Pharmaceutical Solutions - ID: C000106246 - Term: Edotreotide - ID: C000712521 - Term: Edotreotide lutetium LU-177 ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441318 **Brief Title:** A Study to Evaluate the Effect of Povorcitinib on the QT/QTc Interval in Healthy Participants **Official Title:** A Phase 1, Randomized, Partially Double-Blind, Placebo- and Positive-Controlled, Parallel Study to Evaluate the Effect of Povorcitinib on the QT/QTc Interval in Healthy Participants #### Organization Study ID Info **ID:** INCB54707-107 #### Organization **Class:** INDUSTRY **Full Name:** Incyte Corporation ### Status Module #### Completion Date **Date:** 2024-09-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-12 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Incyte Corporation #### 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 evaluate the effect of povorcitinib on the QT/QTc Interval in healthy participants. ### Conditions Module **Conditions:** - Healthy Participants **Keywords:** - INCB054707 ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 128 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Povorcitinib and placebo will be administered at the protocol defined doses. **Intervention Names:** - Drug: Povorcitinib - Drug: Placebo **Label:** Treatment Group 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Povorcitinib will be administered at the protocol defined doses. **Intervention Names:** - Drug: Povorcitinib **Label:** Treatment Group 2 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Placebo will be administered at the protocol defined doses. **Intervention Names:** - Drug: Placebo **Label:** Treatment Group 3 **Type:** PLACEBO_COMPARATOR #### Arm Group 4 **Description:** Moxifloxacin will be administered at the protocol defined doses. **Intervention Names:** - Drug: Moxifloxacin **Label:** Treatment Group 4 **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment Group 1 - Treatment Group 2 **Description:** Povorcitinib will be administered at protocol defined dose. **Name:** Povorcitinib **Other Names:** - INCB054707 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Treatment Group 1 - Treatment Group 3 **Description:** Placebo will be administered at protocol defined dose. **Name:** Placebo **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Treatment Group 4 **Description:** Moxifloxacin will be administered at protocol defined dose. **Name:** Moxifloxacin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Electrocardiogram measurement of the maximum absolute change from baseline in Fridericia's correction for QT interval (QTcF) **Measure:** Change from Baseline in QT interval corrected using Fridericia's formula (QTcF) **Time Frame:** Up to Day 3 **Description:** Electrocardiogram measurement of change from baseline in HR. **Measure:** Change from Baseline in heart rate (HR) **Time Frame:** Up to Day 3 **Description:** Electrocardiogram measurement of change from baseline in PR. **Measure:** Change from Baseline in the PR Interval (PR) **Time Frame:** Up to Day 3 **Description:** Electrocardiogram measurement of change from baseline in QRS. **Measure:** Change from Baseline in the QRS interval (QRS) **Time Frame:** Up to Day 3 #### Secondary Outcomes **Description:** An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a subject provides informed consent. **Measure:** Safety and tolerability as measured by the frequency, duration, and severity of adverse events (AEs) **Time Frame:** Up to Day 22 **Description:** Povorcitinib concentration in plasma. **Measure:** Povorcitinib concentration in plasma **Time Frame:** Up to Day 7 **Description:** Moxifloxacin concentration in plasma. **Measure:** Moxifloxacin concentration in plasma **Time Frame:** Up to Day 7 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Ability to comprehend and willingness to sign a written ICF for the study. * Age 18 to 55 years inclusive at the time of signing the ICF. * Body mass index between 18.0 and 30.5 kg/m2, inclusive. * No clinically significant findings on screening evaluations as determined by the investigator (clinical, laboratory, and ECG). * Ability to swallow and retain oral medication. Exclusion Criteria: * History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening. Participants with any history of myasthenia gravis will be excluded. * Presence or history of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn disease or chronic pancreatitis). * Current or recent (within 3 months of screening) clinically significant gastrointestinal disease or surgery (including cholecystectomy and excluding appendectomy and hernia repair) that could affect the absorption of study drug or moxifloxacin. * History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease or uncontrolled hypertension (systolic blood pressure \> 140 mm Hg or diastolic blood pressure \> 90 mm Hg at screening, confirmed by repeat testing). * Positive test for HBV, HCV, or HIV. Participants whose results are compatible with prior immunization for or immunity due to infection with HBV may be included at the discretion of the investigator. * History of tobacco- or nicotine-containing product-use within 1 month before screening. * Pregnant or breastfeeding. Other protocol-defined Inclusion/Exclusion Criteria may apply. **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Incyte Corporation Call Center (US) **Phone:** 1.855.463.3463 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Incyte Corporation Call Center (ex-US) **Phone:** +800 00027423 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Incyte Corporation **Name:** Incyte Medical Monitor **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000059005 - Term: Topoisomerase II Inhibitors - ID: D000059003 - Term: Topoisomerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Repr - Name: Reproductive Control Agents ### Intervention Browse Module - Browse Leaves - ID: M1722 - Name: Moxifloxacin - Relevance: HIGH - As Found: COPD - ID: M266292 - Name: Norgestimate, ethinyl estradiol drug combination - Relevance: LOW - As Found: Unknown - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077266 - Term: Moxifloxacin ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441305 **Acronym:** R-SWITCH **Brief Title:** Expanding Coverage of Severe Acute Malnutrition (SAM) Treatment in Kenya **Official Title:** Assessing the Impact, Implementation and Cost of Empowering Community Health Promoters to Improve Wasting Treatment Coverage in Turkana County Through Family-led MUAC Scale-up, Weight-for-age Screening, and Defaulters' Follow-up #### Organization Study ID Info **ID:** RSWITCH-Kenya #### Organization **Class:** OTHER **Full Name:** International Food Policy Research Institute ### Status Module #### Completion Date **Date:** 2027-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-03 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** UNICEF **Class:** OTHER **Name:** Kenyatta University #### Lead Sponsor **Class:** OTHER **Name:** International Food Policy 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:** Child wasting is a type of malnutrition which occurs when a child becomes too thin. This medical condition increases the risk of becoming sick or dying. A child with severe wasting needs to be seen in a medical consultation to check on health status and to receive some medicine and a medical food supplement for daily consumption until cured. Yet, only a small proportion of children suffering from severe wasting are presently receiving appropriate treatment. In Kenya, there is an opportunity to build on the existing network of community health promoters (CHPs) to increase the number of children with wasting who are identified and treated. In intervention areas, CHPs will be equipped with smartphones and an application which provides guidance on household members to visit and simple actions to take, related to health. CHPs will distribute color-coded mid-upper arm circumference tapes to households with young children and train caregivers on how to use it. After training, CHPs will send Short Message Services (SMS) to remind caregivers to regularly measure the arm circumference of the child. In addition, CHPs will receive a scale to measure the weight of children every month. Finally, wasted children registered in the treatment program who fail to attend a planned consultation will be flagged to their CHP through the phone application, and CHPs will conduct a specific home visit to investigate and help solve potential issues. The study will assess whether this community intervention (called SWITCH) allows to identify and treat more children suffering from severe wasting. Before the start of the intervention, the proportion of wasted children receiving treatment in 40 community units in Turkana South, Turkana East and Aroo will be assessed. After this survey, a computer will randomly select 20 community units where the intervention will be scaled up. The survey will be repeated after 2 years to assess if the proportion of severely wasted children receiving treatment is higher in the area where the intervention was scaled up compared to the area where it was not scaled up. In addition, after 1 year of implementation, the study will assess how the intervention was scaled up, what are the main challenges, and what are the overall perceptions on the intervention in the community among those who receive it and those who deliver it. Finally, costs of the various components of the intervention will be measured for all actors involved, including for caregivers. **Detailed Description:** Despite the burden and impact of child wasting on morbidity and mortality, only a small proportion of severely wasted children are presently receiving treatment. In Kenya, there is an opportunity to strengthen the screening for wasting and the identification and treatment of wasted children (SWITCH) through community health promoters (CHPs) who, per policy, are trained, equipped, incentivized and supervised by community health agents (CHAs). An intervention package will be implemented including: 1) Digitization to support CHPs, 2) Family-led Mid-Upper Arm Circumference (MUAC) enhanced by digitization, with a two-way messaging platform between CHP and caregivers, and reminders for timely training at 6 months of age, 3) Equipment of CHPs with a baby-mother scale for measurement of weight-for-age to detect likely wasting, and 4) Real-time follow-up in the community (facilitated by digitization) of defaulters and non-respondent children enrolled for wasting treatment. A randomized controlled trial will be used to assess the impact of the SWITCH intervention on severe wasting treatment coverage in Turkana. Twenty randomly selected community units of 40 will receive the intervention. An exhaustive screening campaign conducted at baseline and endline (after 2 years) in the 40 community units will identify children with severe wasting (MUAC \< 115 mm or Weight-for-Height Z-score \< -3 or bilateral pitting oedema) or recovering from severe wasting (defined by receipt and consumption of Ready-to-Use Therapeutic Food), who will be enrolled in a survey assessing treatment coverage, program exposure and other pathways to impact, and confounders. In addition, the study will assess the reach, adoption by CHPs, and implementation challenges of the SWITCH package through additional qualitative (interviews and observations) and quantitative data collection at all levels of program delivery (beneficiaries, CHPs, CHAs, program implementers); and the unit cost of the SWITCH package per beneficiary (and cost-effectiveness if the package is effective) through an activity-based costing-ingredients approach. ### Conditions Module **Conditions:** - Acute Malnutrition, Severe - Malnutrition, Child - Wasting **Keywords:** - Outpatient Therapeutic Feeding Program - Treatment - Screening - Wasting - Severe acute malnutrition ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Cluster randomized controlled trial. Unit/cluster of assignment is community unit catchment area. Parallel Assignment: baseline-endline design ##### Masking Info **Masking:** NONE **Masking Description:** Evaluator teams will be blinded from intervention allocation **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 1600 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** * Register-based household registration (census) by CHP every 12 months * Some family MUAC of variable and unknown coverage/frequency, national guidance developed. * Some passive screening using weight-for-height z-score at Health Facility and during outreach during Malezi bora (child health week every 6 months). * Monthly compilation by CHA (supervisors) of the list of defaulters and non-respondents for transmission to relevant community health promoter (CHP) during monthly in-person meeting. **Label:** Standard of Care **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** * Addition of digital monitoring \& supervision by CHA * Digitized registration of households by CHPs every 6 months * Digital reminders to CHP to conduct home visit if a child has never been visited in 3 mo. * Digital reminder for timely training to family MUAC of all family members through home visit by CHP when child turns 6 months of age. * Platform for 2-ways messaging: biweekly SMS reminders to caregivers through the CHP's app; feedback by caregiver * Community level screening based on weight and weight-for-age (WAZ) led by CHP every other month (aligned with Community Action Days), * Digital calculation of WAZ. * CHP and Growth Monitoring and Promotion refer to health facility if WAZ\<-3 to check on WHZ eligibility * At the end of every wasting treatment consultation, compilation of the list of defaulters and non-respondents, for immediate transmission by CHA to relevant CHP through digital task of an instruction for immediate follow-up. **Intervention Names:** - Behavioral: SWITCH intervention package **Label:** SWITCH intervention package **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - SWITCH intervention package **Description:** * Addition of digital monitoring \& supervision by CHA * Digitized registration of households by CHPs every 6 months * Digital reminders to CHP to conduct home visit if a child has never been visited in 3 mo. * Digital reminder for timely training to family MUAC of all family members through home visit by CHP when child turns 6 months of age. * Platform for 2-ways messaging: biweekly SMS reminders to caregivers through the CHP's app; feedback by caregiver * Community level screening based on weight and weight-for-age (WAZ) led by CHP every other month (aligned with Community Action Days), * Digital calculation of WAZ. * CHP and Growth Monitoring and Promotion refer to health facility if WAZ\<-3 to check on WHZ eligibility * At the end of every wasting treatment consultation, compilation of the list of defaulters and non-respondents, for immediate transmission by CHA to relevant CHP through digital task of an instruction for immediate follow-up. **Name:** SWITCH intervention package **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** defined as the proportion of children suffering from SAM or recovering from SAM who currently receive treatment. • SAM defined by weight-for-height Z-score (WHZ) \<-3 (relative to World Health Organization (WHO) 2006 reference) or MUAC \<115 mm or by the presence of bilateral edema. Children recovering from SAM through treatment will be considered to receive treatment for an initial SAM condition if they both attended an IMAM consultation in the previous 15 days (as reported by caregiver OR by a consultation card) AND either: * consumed RUTF at least once in the previous 3 days (as reported by the caregiver AND confirmed by observation of \>= 1 full or 2 empty RUTF sachets) OR * consumed RUSF at least once in the previous 3 days (as reported by the caregiver AND confirmed by observation by the enumerator of \>= 1 full or 2 empty RUSF sachets) AND child was previously enrolled for SAM treatment immediately prior to MAM treatment (as confirmed by treatment card OR reported by the mother **Measure:** Period prevalence of severe wasting (SAM) treatment coverage in children 6-59 months of age **Time Frame:** After 24 months of program implementation #### Secondary Outcomes **Description:** Defined as the proportion of children with SAM at the time of the survey that are under treatment (see definition under primary outcome) **Measure:** Point prevalence of SAM outpatient therapeutic program (OTP) treatment coverage in children 6-59 months of age **Time Frame:** After 24 months of program implementation **Description:** Defined as the proportion of children aged 6-59 months suffering from SAM ((currently or on their way to recovery from SAM through treatment for an initial SAM condition) ) screened for wasting over the last 30 days (as reported by the caregiver) **Measure:** Screening coverage of SAM **Time Frame:** After 24 months of program implementation **Description:** Defined as the proportion of children aged 6-59 months with SAM (defined as WHZ \<-3 (relative to World Health Organization (WHO) 2006 reference) or a MUAC \< 115 mm or the presence of bilateral pitting edema). **Measure:** Prevalence of SAM **Time Frame:** After 24 months of program implementation **Description:** Defined as the proportion of children aged 6-59 months with WHZ \<-3 (relative to World Health Organization (WHO) 2006 reference). **Measure:** Prevalence of very low WHZ **Time Frame:** After 24 months of program implementation **Description:** Defined as the proportion of children aged 6-59 months with MUAC\<115 mm **Measure:** Prevalence of very low MUAC **Time Frame:** After 24 months of program implementation **Description:** Defined as the proportion of children aged 6-59 months with MAM (defined as -3\<= WHZ \<-2 (relative to World Health Organization (WHO) 2006 reference) or 115\<= MUAC \< 125 mm). **Measure:** Prevalence of moderate acute malnutrition (MAM) **Time Frame:** After 24 months of program implementation **Description:** Defined as the proportion of children aged 6-59 months with wasting (defined as WHZ \<-2 (relative to World Health Organization (WHO) 2006 reference) or a MUAC \< 125 mm or the presence of bilateral pitting edema). **Measure:** Prevalence of wasting **Time Frame:** After 24 months of program implementation **Description:** Defined as the proportion of children aged 6-59 months suffering from SAM or recovering from SAM with stunting (defined as height-for-age Z-scores (HAZ) \<-2 or a MUAC \< 125 mm or the presence of bilateral pitting edema). To calculate HAZ scores the 2006 WHO growth reference will be used **Measure:** Prevalence of stunting **Time Frame:** After 24 months of program implementation **Description:** Defined as the proportion of children aged 6-59 months suffering from SAM or recovering from SAM with underweight (defined as weight-for-age Z-scores (WAZ) \<-2 ) and severe underweight (defined as WAZ \<-3 ). To calculate WAZ scores the 2006 WHO growth reference will be used **Measure:** Prevalence of underweight and severe underweight **Time Frame:** After 24 months of program implementation **Description:** In 6-59 months old children suffering from SAM or recovering from SAM. Scores will be calculated relative to World Health Organization (WHO) 2006 reference, with a higher score meaning a better outcome **Measure:** Mean height-for-age Z-score (HAZ) **Time Frame:** After 24 months of program implementation **Description:** In 6-59 months old children.To calculate WHZ scores the 2006 WHO growth reference will be used **Measure:** Mean weight-for-height Z-score (WHZ) **Time Frame:** After 24 months of program implementation **Description:** In 6-59 months old children.To calculate WAZ scores the 2006 WHO growth reference will be used **Measure:** Mean weight-for-age Z-score (WAZ) **Time Frame:** After 24 months of program implementation **Description:** In 6-59 months old children. **Measure:** Mean mid-upper arm circumference (MUAC) **Time Frame:** After 24 months of program implementation **Description:** The score will be calculated by adding one point for each right answer to a series of questions related to infant and child feeding, child health and hygiene, the condition of severe acute malnutrition, outpatient therapeutic programs, screening of wasting. Questions were specifically developed for the study based on program activities and asked to caregiver of children aged 6-59 months suffering from SAM or recovering from SAM **Measure:** Caregiver's knowledge score **Time Frame:** After 24 months of program implementation **Description:** Proportion of children aged 6-18 months with SAM or enrolled in SAM OTP who received all recommended immunizations **Measure:** Prevalence of appropriate immunization **Time Frame:** After 24 months of program implementation **Description:** proportion of children aged 6-59 months suffering from SAM or recovering from SAM who attended an IMAM consultation in the previous 15 days (as reported by the caregiver or by an IMAM treatment card) **Measure:** Coverage of the integrated management of acute malnutrition (IMAM) platform **Time Frame:** After 24 months of program implementation **Description:** proportion of children aged 6-59 months suffering from SAM or recovering from SAM in contact with a CHP in the 2 months preceding the survey for community care-related matter (as reported by the caregiver) **Measure:** Coverage of the community unit platform **Time Frame:** After 24 months of program implementation **Description:** proportion of children aged 6-59 months suffering from SAM or recovering from SAM screened in the month preceding the survey by a family member using a MUAC tape (as reported by the caregiver) **Measure:** Coverage of family MUAC **Time Frame:** After 24 months of program implementation **Description:** proportion of children aged 6-59 months suffering from SAM or recovering from SAM for which at least one family member was trained to use MUAC tape (as reported by the caregiver) **Measure:** Coverage of family MUAC training **Time Frame:** After 24 months of program implementation **Description:** proportion of children aged 6-59 months suffering from SAM or recovering from SAM for which at least one family member owns a MUAC tape (as reported by the caregiver AND confirmed by observation) **Measure:** Coverage of MUAC tapes **Time Frame:** After 24 months of program implementation **Description:** proportion of children aged 6-59 months suffering from SAM or recovering from SAM weighed in the 2 months preceding the survey by a CHP or a health staff using a scale (as reported by the caregiver) **Measure:** Coverage of WAZ screening **Time Frame:** After 24 months of program implementation **Description:** In children aged 6-59 months suffering from SAM or recovering from SAM, defined as the number of days of illness (acute respiratory infections, fever, diarrhea, vomiting) in the past 3 days (as reported by the caregiver) divided by the total number of days of report (usually 3). A diarrheal episode is defined as at least three loose stools in the last 24 hours, or stools with blood. Fever will be measured by a thermometer by enumerators and the history of fever in the previous days will also be recalled from the mother. The presence of an acute respiratory infection (ARI) will be assessed by recalling the specific symptoms associated with ARI (cough, difficulty breathing, rapid breathing, runny nose). **Measure:** Mean longitudinal prevalence of child morbidity **Time Frame:** After 24 months of program implementation ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Household in a village of the study area covered by a CHP (although the child may or may not be registered by a CHP) AND * Child is 6-59.9 months of age AND * Caregiver consents to be part of the study AND * any of the following: * WHZ \< -3 (relative to WHO 2006 reference) OR * MUAC \<115 mm OR * Presence of bilateral edema OR * receiving treatment as follow-up for an initial SAM condition on the way to full recovery exclusion criteria is: * Congenital malformation that makes anthropometric measurements impossible. * Length is below 54 cm or height is above 120cm. **Healthy Volunteers:** True **Maximum Age:** 5 Years **Minimum Age:** 6 Months **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Elodie Becquey, PhD **Phone:** 778487085 **Phone Ext:** +221 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Sophie Ochola, PhD **Phone:** 0721449803 **Phone Ext:** +254 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** International Food Policy Research Institute **Name:** Elodie Becquey, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Kenyatta University **Name:** Sophie Ochola, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** All data will be carefully anonymized and de-identified so that the privacy of participants and research subjects is fully protected. Databases will be anonymized using identification codes. No names, GPS coordinates, dates of birth or other identifying data will be stored in the databases. At the time of publication of scientific articles presenting primary results, the fully anonymized databases (quantitative data) will become a public good and will be made available to the scientific community, government, and partners. **Info Types:** - STUDY_PROTOCOL - SAP **IPD Sharing:** YES **Time Frame:** At the time of publication of scientific articles presenting primary results. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009748 - Term: Nutrition Disorders - ID: D000015431 - Term: Weight Loss - ID: D000001836 - Term: Body Weight Changes - ID: D000001835 - Term: Body Weight - ID: D000013851 - Term: Thinness - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown - ID: M25306 - Name: Malnutrition - Relevance: HIGH - As Found: Malnutrition - ID: M21265 - Name: Wasting Syndrome - Relevance: HIGH - As Found: Wasting - ID: M106 - Name: Severe Acute Malnutrition - Relevance: HIGH - As Found: Severe Acute Malnutrition - ID: M5363 - Name: Cachexia - Relevance: HIGH - As Found: Wasting - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M18049 - Name: Child Nutrition Disorders - Relevance: HIGH - As Found: Malnutrition, Child - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: M18102 - Name: Weight Loss - Relevance: LOW - As Found: Unknown - ID: M5115 - Name: Body Weight Changes - Relevance: LOW - As Found: Unknown - ID: M16614 - Name: Thinness - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000044342 - Term: Malnutrition - ID: D000019282 - Term: Wasting Syndrome - ID: D000067011 - Term: Severe Acute Malnutrition - ID: D000015362 - Term: Child Nutrition Disorders - ID: D000002100 - Term: Cachexia ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441292 **Brief Title:** Multi-Modal Image Fusion for Precision Prostate Biopsy Navigation **Official Title:** Study on Prostate Targeted Biopsy Precision Navigation Method Based on Multi-Modal Image Fusion Deep Learning Using Multi-Parameter Ultrasound and MRI #### Organization Study ID Info **ID:** PB-NAV-MMIF-01 #### Organization **Class:** OTHER **Full Name:** Shanghai East Hospital ### Status Module #### Completion Date **Date:** 2025-07-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-28 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Shanghai East Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study is a prospective randomized controlled clinical trial aimed at comparing the detection rates of clinically significant prostate cancer between conventional biopsy methods and AI-assisted biopsy methods in patients undergoing initial prostate biopsy who meet the indications for prostate biopsy. **Detailed Description:** This study is a prospective randomized controlled clinical trial designed to investigate the efficacy of AI-assisted biopsy methods compared to conventional biopsy methods in detecting clinically significant prostate cancer. The target population includes patients undergoing their initial prostate biopsy who meet established indications for prostate biopsy. ### Conditions Module **Conditions:** - Prostate Cancer **Keywords:** - Prostate Cancer - targeted biopsy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 602 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** undergo standard prostate biopsy procedures without additional technological assistance **Intervention Names:** - Procedure: Non-AI-assisted **Label:** conventional biopsy group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** utilize advanced deep learning models that integrate multi-modal image fusion from multi-parameter ultrasound and MRI to guide the biopsy process **Intervention Names:** - Procedure: AI-assisted **Label:** AI-assisted biopsy group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - AI-assisted biopsy group **Description:** utilize advanced deep learning models that integrate multi-modal image fusion from multi-parameter ultrasound and MRI to guide the biopsy process **Name:** AI-assisted **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - conventional biopsy group **Description:** undergo standard prostate biopsy procedures without additional technological assistance **Name:** Non-AI-assisted **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The proportion of men with a Gleason score ≥3+4 in pathological assessment for targeted biopsy samples **Measure:** The detection rate of clinically significant prostate cancer by targeted biopsy alone **Time Frame:** 2-3 weeks post-biopsy #### Secondary Outcomes **Description:** The proportion of men with a Gleason score ≥3+4 in pathological assessment for combined targeted biopsy samples **Measure:** The detection rate of clinically significant prostate cancer by targeted biopsy combined with template biopsy **Time Frame:** 2-3 weeks post-biopsy **Description:** The proportion of men with a Gleason score ≥3+3 in pathological assessment for targeted biopsy samples **Measure:** The detection rate of any prostate cancer by targeted biopsy alone **Time Frame:** 2-3 weeks post-biopsy **Description:** The proportion of men with a Gleason score ≥3+3 in pathological assessment for combined targeted biopsy samples **Measure:** The detection rate of any prostate cancer by targeted biopsy combined with template biopsy **Time Frame:** 2-3 weeks post-biopsy ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age \> 18 2. PSA \> 4 ng/ml and/or abnormal DRE 3. Sign the informed consent Exclusion Criteria: 1. Have acute or chronic prostatitis 2. Contraindications to prostate biopsy 3. Contraindications to MRI 4. Other reasons that not suitable for this trial **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** shuaidong wang **Phone:** 15102100859 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** haifeng wang **Phone:** 13681750891 **Role:** CONTACT #### Locations **Location 1:** **City:** Shanghai **Country:** China **Facility:** Shanghai East Hospital, Tongji University School of Medicine **Zip:** 200120 ### 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 ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441279 **Brief Title:** Treatment of Tempromandibular Joint Anterior Disc Displacement With Different Materials **Official Title:** Hyaluronic Acid Versus Platelet Lysate in The Treatment of Temporomandibular Joint Anterior Disc Displacement With Reduction: A Randomized Clinical Trial #### Organization Study ID Info **ID:** A0103024OS #### Organization **Class:** OTHER **Full Name:** Mansoura University ### Status Module #### Completion Date **Date:** 2024-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mansoura University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** comparing the clinical efficacy of intra-articular injection of platelet lysate (PL), versus Hyaluronic Acid after arthrocentesis in the management of patients with anterior disc displacement with reduction. ### Conditions Module **Conditions:** - TMJ Disc Disorder ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 30 patients that will have intra-articular injection of 2 ml of Platelet lysate (PL). **Intervention Names:** - Procedure: intra-articular injection with Platelet lysate (PL). **Label:** group 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 30 patients that will have intra-articular injection of Hyaluronic Acid. **Intervention Names:** - Procedure: intra-articular injection with Hyaluronic Acid. **Label:** group 2 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - group 1 **Description:** 2 ml of Platelet lysate will be deposited into the superior joint space (SJS) in the affected joint at the entry point slowly **Name:** intra-articular injection with Platelet lysate (PL). **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - group 2 **Description:** 2 ml of Hyaluronic Acid will be deposited into the superior joint space (SJS) in the affected joint at the entry point slowly. **Name:** intra-articular injection with Hyaluronic Acid. **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Maximum inter-incisal opening will be measured by Vernier caliper and this will be recorded by photographs. **Measure:** Maximum inter-incisal opening **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients that will be diagnosed with anterior disc displacement with reduction (ADDWR) both clinically and through magnetic resonance imaging scan (MRI). * Patients who will not respond to a previous conservative therapy. * Patients with pain in temporomandibular joints. * Patients with normal or limitation in mouth opening. * Patients with clicking sound. Exclusion Criteria: * Patients with previous invasive TMJ surgical procedures. * Patients with inflammatory or connective tissue diseases. * Patients with neurologic disorders. * Patients with history of bony or fibrous adhesion. * Patients having gross mechanical restrictions and condylar fractures. * Patients with psychological problems. * Patients receiving anti-coagulation treatment, non-steroidal anti-inflammatory drugs within 48 hours pre-operatively, corticosteroid injection at the treatment site within one month or systemic use of corticosteroids within 2 weeks. **Healthy Volunteers:** True **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** heba elsheikh, assistant professor **Phone:** 00201024461010 **Role:** CONTACT #### Locations **Location 1:** **City:** Mansoura, Egypt **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** heba elsheikh, assistant professor - **Phone:** 00201024461010 - **Role:** CONTACT **Country:** Egypt **Facility:** Heba Elsheikh **Status:** RECRUITING **Zip:** 002 ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000000276 - Term: Adjuvants, Immunologic - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000055675 - Term: Viscosupplements - ID: D000020011 - Term: Protective Agents ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M9878 - Name: Hyaluronic Acid - Relevance: HIGH - As Found: Users - ID: M3628 - Name: Adjuvants, Immunologic - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M28295 - Name: Viscosupplements - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000006820 - Term: Hyaluronic Acid ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441266 **Brief Title:** M-PART in Head and Neck Cancer Patients Treated With KeraStat Cream for Acute Radiation Dermatitis **Official Title:** Pilot Study of Multi-platform Assessment of Radiation Toxicity (M-PART) in Head and Neck Cancer Patients Treated With KeraStat® Cream for Acute Radiation Dermatitis #### Organization Study ID Info **ID:** ONC-HN-2404 #### Organization **Class:** OTHER **Full Name:** Wake Forest University Health Sciences #### Secondary ID Infos **ID:** P30CA012197 **Link:** https://reporter.nih.gov/quickSearch/P30CA012197 **Type:** NIH ### Status Module #### Completion Date **Date:** 2026-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-08 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Cancer Institute (NCI) #### Lead Sponsor **Class:** OTHER **Name:** Wake Forest University Health Sciences #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this research study is to test the ability of a mobile device application (MyCap) to collect patient information about their radiation skin rash in patients with head and neck cancer being treated with radiation therapy. **Detailed Description:** Primary Objective: To determine the feasibility of M-PART for the assessment of acute radiation dermatitis in patients treated with radiotherapy for head and neck cancer via MyCap. Secondary Objectives: * To assess agreement between site clinician-rated CTCAE G2+ radiation dermatitis with moist desquamation and patient-reported moist desquamation (a and b above). * To assess the proportion of patient-submitted photographs of skin in the irradiated area that are evaluable for radiation dermatitis assessments by central review. * To assess agreement between clinician-rated radiation dermatitis grading, central review of patient-submitted photographs, and central review of standardized clinic photographs (methods a, c, and d above). * To measure the level of interval (i.e., optional engagement in between scheduled collection) patient engagement in the collection of radiation toxicity outcomes using the M-PART methodology. * To measure patient and research staff satisfaction, perceptions, and preferences with regard to the M-PART data collection framework. ### Conditions Module **Conditions:** - Radiation Dermatitis ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 16 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Assessment through the MyCap app to assess radiation dermatitis with the use of Kerastat cream. **Intervention Names:** - Device: KeraStat cream - Device: M-PART Assessments via MyCap - Other: Clinical Assessments - Other: Feedback phone interview **Label:** M-PART Assessment via MyCap **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - M-PART Assessment via MyCap **Description:** KeraStat Cream is a non-sterile, non-implantable, emollient-based wound dressing intended to act as a protective covering in the management of a variety of skin conditions. The intervention is a topical cream applied at least twice daily starting at start of radiation therapy until 1-month from the end of radiation therapy completion **Name:** KeraStat cream **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - M-PART Assessment via MyCap **Description:** The M-PART approach harnesses the remote data collection capabilities of MyCap to facilitate remote collection or data including but not limited to toxicity assessments, quality of life surveys, and patient-provided photographs of the skin in the treated area **Name:** M-PART Assessments via MyCap **Type:** DEVICE #### Intervention 3 **Arm Group Labels:** - M-PART Assessment via MyCap **Description:** Participants will undergo assessments at baseline (prior to radiation therapy start), weekly during and after radiation therapy until 1-month post-radiation therapy. Medical history will be collected at baseline including primary cancer site, HPV status (if oropharyngeal cancer primary), laterality, TNM classification, stage, surgical resection prior to radiation therapy, weight, body mass index and patient self-reported Fitzpatrick skin phototype. **Name:** Clinical Assessments **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - M-PART Assessment via MyCap **Description:** Participant satisfaction, perceptions and preferences with using M-PART will be discussed. **Name:** Feedback phone interview **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Participants to complete 75% or more of required assessments over the course of the study will be calculated in two steps. First, investigators will separate patients into two groups, those who have completed 75% or more of their scheduled assessments over all time periods, and those who have not. Investigators will then divide the former number by the total number of patients who completed the study (i.e., completed their radiation treatment) with a final anticipated analyzable number of 16, using a 95% confidence interval. Thus, if 50% or more of the patients in the sample have completed at least 75% of scheduled assessments, the study will be deemed feasible to conduct a future study using M-PART. **Measure:** Number of Participants that Complete Scheduled Study Assessments to Measure for Feasibility **Time Frame:** 2 years #### Secondary Outcomes **Description:** To measure agreement between site clinician reported grade 2+ radiation dermatitis with moist desquamation (yes/no) and patient-reported moist desquamation (any/none) at each weekly visit, investigators will use McNemar's test, which tests the null hypothesis that there is no difference between site clinician-reported and patient-reported presence of moist desquamation. Investigators will also estimate sensitivity and specificity (relative to the gold standard site clinician report) of the participant's self-reported moist desquamation yes/no. We will also examine whether agreement appears to vary meaningfully by week. **Measure:** Number of Participants to Self-Report Presence of Radiation Dermatitis Compared to Site Clinician Reported Radiation Dermatitis. **Time Frame:** At baseline, weekly during radiation therapy, weekly for 4 weeks post radiation therapy, up to 2 years **Description:** The number of scheduled patient-submitted photographs (submitted through MyCap as part of the scheduled/required assessments) that are evaluable (if the central reviewer is able to provide a radiation dermatitis grade) in at least two different ways. First, in the most straightforward calculation, investigators will use as the denominator the total number of patient-submitted photographs that were scheduled, with the numerator being the number of photographs that are able to be graded for radiation dermatitis by a central reviewer. Second, to examine the possibility of intra-person correlation in evaluable photographs, investigators will compute for each individual patient the proportion of their photographs that were deemed evaluable and examine the distribution of these individual-level proportions in the sample. Finally, we will also carry out the above two calculations considering all photographs (scheduled and interval). **Measure:** Percentage of Participant-Submitted Photographs Evaluable for Radiation Dermatitis Grading **Time Frame:** At baseline, weekly during radiation therapy, weekly for 4 weeks post radiation therapy, up to 2 years **Description:** To assess agreement between the three different methods of grading (clinician-rated radiation dermatitis grading, participant-submitted photographs and standardized clinic photographs) investigators will compare two methods at a time in a contingency table, and estimate proportion agreeing by focusing on the diagonal where ratings of grade were identical. Investigators will also dichotomize the ordinal grades into grade 2+ yes/no and compute McNemar's test for each dichotomous comparison of ratings. Finally, investigators will also compute measures of sensitivity and specificity regarding grade 2+ yes/no again considering site clinician ratings as the gold standard. **Measure:** Proportion of Agreement in Grading Methods for Radiation Dermatitis **Time Frame:** At baseline, weekly during radiation therapy, weekly for 4 weeks post radiation therapy, up to 2 years **Description:** To measure the level of patient engagement in the interval collection of radiation dermatitis outcomes, investigators will estimate the proportion of the total samples who provide any (vs no) interval assessment information through MyCap, and will also examine the frequency distribution of the number of such interval assessments provided among the whole sample. Additionally, investigators will make the denominator more specific by utilizing the question on the weekly scheduled patient-reported outcomes form that asks patients if they have noticed the starting or ending of moist desquamation in the interval between clinical visits, and examine what proportion of patients who answer yes on this question sent in interval information (pictures, patient-reported outcomes) during the relevant interval. **Measure:** Number of Skin Assessments Provided Through MyCap - Patient Engagement **Time Frame:** At baseline, weekly during radiation therapy, weekly for 4 weeks post radiation therapy, up to 2 years **Description:** The analysis of patient satisfaction, perceptions and preferences will depend on the measure of collection. For the semi-quantitative survey, investigators will compile simple descriptive statistics showing frequencies and proportions of participants in each category of response to each question. **Measure:** Frequency in Responses to Satisfaction with M-PART - Semi-Quantitative Survey **Time Frame:** 4 weeks after completion of radiation therapy, up to 2 years **Description:** For the qualitative interviews of patients and staff, investigators will analyze the transcripts using a thematic analysis approach. Trained qualitative researchers will review the interview transcripts and use a combined inductive-deductive approach to develop a codebook of concepts important to patient and staff satisfaction and experience with M-PART. Codes will be applied to data in a multifunctional data management and analysis software, and the codebook will be revised as needed during the analysis to best categorize and interpret the data. All transcripts will be independently coded by two researchers, and coding discrepancies will be discussed and resolved iteratively. Segments of text will be abstracted by code or groups of codes, summarized, and synthesized into themes. **Measure:** Frequency in Responses to Satisfaction with M-PART - Qualitative Interviews **Time Frame:** 4 weeks after completion of radiation therapy, up to 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: - Histological or cytological diagnosis of head and neck cancer (of any part of the oral cavity, pharynx, larynx, or sinuses) planned to receive conventionally fractionated radiation therapy (RT) targeting the head and neck to a total prescribed dose of at least 60 Gy. The 60 Gy RT target must include at least a part of the unilateral and/or bilateral lymph node regions of the head/neck. Planned prescribed dose will be reviewed and approved by the study PI. NOTE: Patients without a clear pathologic diagnosis of invasive disease (i.e., biopsy showing at least carcinoma in situ) but with clinically diagnosed head and neck cancer planned for treatment as above are also eligible. * Age ≥ 18 years at the time of enrollment. * Able and willing to complete electronic toxicity and quality of life assessments in the MyCap application using their personal mobile device. * Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative) in English. Exclusion Criteria: * Early stage (Stage I-II) squamous cell carcinoma of the glottic larynx planned for treatment with limited field radiation therapy alone. These participants are excluded since they are expected to receive a more limited exposure to radiation therapy. * Patients planned for treatment to the primary site alone without regional lymph node targeting. * Previous radiation therapy to the area in the head and neck to be treated with radiation therapy. * Active use of topical corticosteroids in the irradiation area at the time of registration. * History of scleroderma or active lupus requiring systemic medication at the time of registration. * Planned concurrent treatment with anti-EGFR biologic therapy (e.g., cetuximab) for head and neck cancer. * Individuals who are pregnant or plan to become pregnant. Radiotherapy is contraindicated in this patient population. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Principal Investigator **Phone:** 336-713-3600 **Role:** CONTACT #### Locations **Location 1:** **City:** Winston-Salem **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Principal Investigator - **Phone:** 336-713-3600 - **Role:** CONTACT ***Contact 2:*** - **Name:** Ryan T. Hughes, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Wake Forest Baptist Comprehensive Cancer Center **State:** North Carolina **Zip:** 27157 #### Overall Officials **Official 1:** **Affiliation:** Wake Forest Baptist Comprehensive Cancer Center **Name:** Ryan T Hughes, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000012871 - Term: Skin Diseases - ID: D000011832 - Term: Radiation Injuries - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: HIGH - As Found: Head and Neck Cancer - ID: M7067 - Name: Dermatitis - Relevance: HIGH - As Found: Dermatitis - ID: M14701 - Name: Radiodermatitis - Relevance: HIGH - As Found: Radiation Dermatitis - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M14679 - Name: Radiation Injuries - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000003872 - Term: Dermatitis - ID: D000011855 - Term: Radiodermatitis ### Intervention Browse Module - Browse Branches - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M7809 - Name: Emollients - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441253 **Brief Title:** Development and Evaluation of a Portable Wedge Device for Calf Stretching to Alleviate Strain and Spasms **Official Title:** Development and Evaluation of a Portable Wedge Device for Calf Stretching to Alleviate Strain and Spasms: A RCT Study #### Organization Study ID Info **ID:** MSRSW/Batch-Fall22/718 #### Organization **Class:** OTHER **Full Name:** Superior University ### Status Module #### Completion Date **Date:** 2024-10-29 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-03 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-05-01 **Type:** ACTUAL #### Start Date **Date:** 2023-11-01 **Type:** ACTUAL **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-25 **Study First Submit QC Date:** 2024-06-03 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Superior University #### Responsible Party **Investigator Affiliation:** Superior University **Investigator Full Name:** Muhammad Naveed Babur **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:** This research aimed to contribute valuable insights into the potential benefits of incorporating the portable wedge device into preventive or therapeutic interventions for calf-related musculoskeletal issues. **Detailed Description:** By combining economical, ergonomic principles and user-friendly features, the proposed device offered individuals a convenient and efficient means to enhance their calf flexibility, ultimately mitigating strain and reducing spasms. Developing and successfully integrating a portable wedge device could mark a significant breakthrough in preventive and rehabilitative care for musculoskeletal problems associated with the calf region. This innovative device can enhance the overall well-being and musculoskeletal health of individuals suffering from such issues, providing a more effective and convenient treatment solution. ### Conditions Module **Conditions:** - Spasm ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 26 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Diagnostic Test: Deep Friction massage **Label:** Deep Friction massage **Type:** OTHER #### Arm Group 2 **Intervention Names:** - Combination Product: Therapeutic exercises **Label:** Therapeutic exercises **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Deep Friction massage **Description:** The calf muscles received a firm, deep-circulation massage with fingertip pressure **Name:** Deep Friction massage **Type:** DIAGNOSTIC_TEST #### Intervention 2 **Arm Group Labels:** - Therapeutic exercises **Description:** Four stretching exercises were performed for twenty minutes, five minutes for each technique, and eight to ten repetitions of each exercise (calf wall stretch, back knee straight, bilateral calf stretches, knees straight, ankle plantarflexion/dorsiflexion) **Name:** Therapeutic exercises **Type:** COMBINATION_PRODUCT ### Outcomes Module #### Primary Outcomes **Description:** subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 for "no pain" and 10 for "worst pain". **Measure:** Visual Analog Scale **Time Frame:** 12 Months **Description:** The FADI has 26 items. Each item is scored from 0 (unable to do) to 4 (no difficulty at all). The 4 pain items of the FADI are scored 0 (unbearable) to 4 (none). The FADI has a total point value of 104 points, whereas the FADI Sport has a total point value of 32 points. **Measure:** Functional Disability Scale for Ankle (FADI) **Time Frame:** 12 months **Description:** This tool measures the angle of dorsiflexion before and after the intervention, offering insights into the functional improvements resulting from the use of the portable wedge device. Additionally, participant satisfaction and compliance will be assessed through a structured questionnaire. **Measure:** Range of motion (ROM) **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male and female patients diagnosed with Calf Strain and Spasm * Age above 18 * Participants who are volunteer for the study * Patients who suffer from leg pain or functional disability Exclusion Criteria: * Unconscious patients * Patients with difficulty in seeing and hearing * Patients having a history of mental illnesses (Stroke, Multiple sclerosis, Parkinsonism, Alzheimer's Disease) * Patient history of severe mobility disorder * Systemic illness (Liver Failure, Active cancer, Cardiopulmonary distress) * Decline to participate in this study * Active fracture and dislocations * Arthritic disorders (such as osteoarthritis, Rheumatoid Arthritis, Psoriatic Arthritis, and Fibromyalgia) **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Lahore **Country:** Pakistan **Facility:** Faqraj Sharif Hospital (Trust) Physiotherapy and Orthopedic Department and Ramay Clinic (Physiotherapy and Orthopedic Department) **State:** Punjab ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020879 - Term: Neuromuscular Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases ### Condition Browse Module - Browse Leaves - ID: M15837 - Name: Spasm - Relevance: HIGH - As Found: Spasm - ID: M12077 - Name: Muscle Cramp - 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: D000013035 - Term: Spasm ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441240 **Acronym:** NEORISK **Brief Title:** Evaluation of Recurrence Risk Factors in Locally Advanced Breast Cancer Patients Underwent Neoadjuvant Chemotherapy. **Official Title:** Evaluation of Recurrence Risk Factors in Locally Advanced Breast Cancer Patients Underwent Neoadjuvant Chemotherapy. The NEORISK Study. #### Organization Study ID Info **ID:** 6081 #### Organization **Class:** OTHER **Full Name:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Status Module #### Completion Date **Date:** 2026-03-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-11-01 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-04-29 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** INTRODUCTION Breast cancer (BC) is the leading cause of cancer-related death in women. Since the early 1980s, the implementation of screening programs has reduced the number of patients diagnosed with locally advanced breast cancer. Currently, the treatment for these patients involves initial neoadjuvant chemotherapy (NACT) followed by surgical treatment. In recent years, NACT has also been used for highly chemoresponsive tumors such as triple-negative (TN) and HER2-positive (HER2+) breast cancer. The widespread use of NACT has led to additional benefits, including downstaging of breast and axillary neoplasms, resulting in reduced morbidity; improved cosmetic outcomes due to increased use of conservative interventions; and personalized adjuvant chemotherapy treatment. Several studies have shown that response to chemotherapy predicts better systemic outcomes. Complete pathological response (pCR), defined as the absence of invasive neoplastic residue in the surgical specimen, has been predictive of better distant outcomes. Limited evidence exists regarding other predictive factors for distant outcomes. Given the significant impact of disease recurrence on patient prognosis, efforts have been made to understand the factors contributing to recurrence and to predict which patients are more prone to relapse. In this context, the term "Early Disease Recurrence" (EDR) has been coined to define the occurrence of disease recurrence, both locally and distantly, within 3 years after completing treatment. In recent years, the potential of radiomic analysis in aiding diagnostic and therapeutic decision-making processes in BC has been demonstrated. Specifically, radiomic features obtained from Magnetic Resonance Imaging (MRI) images appear capable of predicting tumor receptor status, differentiating tumor subtypes, and predicting response to NACT. Although the role of radiomics in predicting recurrence has been investigated, research is still in its early stages, and there are variations in technology and methodology for extracting radiomic features. Additionally, to date, no studies have evaluated the feasibility and reliability of using radiomic models combined with clinical and radiological variables to predict disease recurrence in BC patients undergoing NACT. ### Conditions Module **Conditions:** - Breast Cancer - Chemotherapy Effect - Triple Negative Breast Cancer - Recurrence, Local Neoplasm - Risk Factors ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 933 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients undergoing neoadjuvant chemotherapy and subsequent surgical treatment. Patients must have undergone radiological evaluation by MRI at the beginning and end of chemotherapy treatment **Intervention Names:** - Diagnostic Test: MRI **Label:** Breast cancer patients underwent neoadjuvant chemotherapy ### Interventions #### Intervention 1 **Arm Group Labels:** - Breast cancer patients underwent neoadjuvant chemotherapy **Description:** Breast MRI **Name:** MRI **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Frequency of molecular subtypes (Her2 positive, hormone receptor-positive/Her2 negative, Triple Negative) in the considered cases **Measure:** Description of molecular subtypes **Time Frame:** 7 years **Description:** Association between radiomic features extracted from pre-operative MRI and the onset of disease recurrence within 3 years from the end of neoadjuvant treatment **Measure:** Association between radiomic features and risk of recurrence **Time Frame:** 7 years #### Secondary Outcomes **Description:** Evaluate whether clinical features (divided into: age assessed in years, menopausal status divided into menopausal or fertile age), radiological features such as initial extent of disease and lymph node involvement at diagnosis) and biomolecular features (such as histotype: divided into ductal, lobular or nonspecial type, grading, hormone receptor status) influence response to neoadjuvant chemotherapy Translated with DeepL.com (free version) **Measure:** Association between chemotherapy and neoplastic characteristics **Time Frame:** 7 years **Description:** Frequency of radiological response according to molecular subtype, treatment, type of imaging examination used, and initial staging. **Measure:** Evaluation of radiological response **Time Frame:** 7 years **Description:** Frequency of complete pathological response according to molecular subtype, treatment, and initial staging. **Measure:** Frequency of complete pathological response **Time Frame:** 7 years **Description:** Frequency of surgical procedures based on radiological response, molecular subtypes, and initial staging. **Measure:** Description of surgical treatment according to the cancer characteristics **Time Frame:** 7 years **Description:** Frequency of adjuvant therapies based on neoadjuvant treatment, molecular subtypes, and initial staging. **Measure:** Description of adjuvant treatments **Time Frame:** 7 years **Description:** Disease-free survival (DFS) measured from the start of neoadjuvant therapy to the first evidence of disease recurrence or death, whichever occurs first. **Measure:** Evaluation of oncological outcomes **Time Frame:** 7 years **Description:** Accuracy of pure models (radiomic/clinical/radiological) and combined models in predicting disease recurrence within 3 years from the end of neoadjuvant treatment **Measure:** Assessment of risk of recurrence using models **Time Frame:** 7 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Histological diagnosis of locally advanced Luminal or HER2+ or Triple-negative breast cancer (cT2, T3, T4 N0 or any T N1, N2, N3, M0), clinical stage of disease from I to III. * Patient undergoing neoadjuvant chemotherapy treatment from January 1, 2014, to June 30, 2021. * Age \> 18 years * Availability of clinical data, staging MRI diagnostic images (for the radiomic sub-study), and biomolecular data. Exclusion Criteria: * Previous or synchronous history of systemic malignancies. * History of ipsilateral or contralateral breast neoplasia. * Evidence of metastatic disease (Stage IV). * Neoadjuvant treatment with hormone therapy. * Patients with unavailable or low-quality MRI images that did not allow lesion identification (for the radiomic study only). **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** All patients with breast cancer (Stage I, II, and III) undergoing NACT at our center between January 2014 and June 2021 will be included, for an estimated total of 933 patients. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Alessandra Fabi **Phone:** 0630157337 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Antonio Franco **Phone:** 0630157337 **Role:** CONTACT #### Locations **Location 1:** **City:** Roma **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Alessandra Fabi - **Phone:** +390630153773 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Alessandra Fabi - **Phone:** +390630155701 - **Role:** CONTACT **Country:** Italy **Facility:** Fondazione Policlinico Universitario A. Gemelli - IRCCS **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Policlinico Gemelli **Name:** Alessandra Fabi **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: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000009385 - Term: Neoplastic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M14850 - Name: Recurrence - Relevance: HIGH - As Found: Recurrence - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M30373 - Name: Triple Negative Breast Neoplasms - Relevance: HIGH - As Found: Triple Negative Breast Cancer - ID: M12309 - Name: Neoplasm Recurrence, Local - Relevance: HIGH - As Found: Recurrence, Local Neoplasm - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M12330 - Name: Neoplastic Processes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms - ID: D000064726 - Term: Triple Negative Breast Neoplasms - ID: D000009364 - Term: Neoplasm Recurrence, Local - ID: D000012008 - Term: Recurrence ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441227 **Brief Title:** Safety and Tolerance of Increased Doses of HRS-5346 Tablets in Healthy Subjects **Official Title:** Phase I Clinical Study on the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics and Food Effects of Single and Multiple Oral HRS-5346 Tablets in Healthy Subjects #### Organization Study ID Info **ID:** HRS-5346-101 #### Organization **Class:** INDUSTRY **Full Name:** Shandong Suncadia Medicine Co., Ltd. ### Status Module #### Completion Date **Date:** 2025-01-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-28 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Shandong Suncadia Medicine Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is a randomized, double-blind, placebo-controlled phase I clinical study. The primary objective is to evaluate the safety, tolerability, PK, and PD of single- and multiple-dose HRS-5346 in healthy subjects, and to evaluate the food effects on PK of HRS-5346. ### Conditions Module **Conditions:** - Lipoprotein Disorder Disease ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** HRS-5346 tablets or placebo single dose **Intervention Names:** - Drug: HRS-5346 tablets - Drug: placebo **Label:** Part 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** HRS-5346 tablets or placebo single dose with food effects **Intervention Names:** - Drug: HRS-5346 tablets - Drug: placebo **Label:** Part 2 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** HRS-5346 tablets or placebo multiple doses **Intervention Names:** - Drug: HRS-5346 tablets - Drug: placebo **Label:** Part 3 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Part 1 - Part 2 - Part 3 **Description:** Part 1: single dose. Part 2: single dose with food effects. Part 3: single dose multiple doses. **Name:** HRS-5346 tablets **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Part 1 - Part 2 - Part 3 **Description:** Part 1: single dose. Part 2: single dose with food effects. Part 3: single dose multiple doses. **Name:** placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Assess the incidence and severity of adverse events in healthy subjects after single and multiple doses of HRS-5346 tablets **Time Frame:** About three months from the first medication to the evaluation #### Secondary Outcomes **Measure:** Evaluation of AUC0-t of HRS-5346 in plasma and urine **Time Frame:** About three months after the first dose **Measure:** Evaluation of AUC0-inf of HRS-5346 in plasma **Time Frame:** About three months after the first dose **Measure:** Evaluation of Tmax of HRS-5346 in plasma **Time Frame:** About three months after the first dose **Measure:** Evaluation of Cmax of HRS-5346 in plasma **Time Frame:** About three months after the first dose **Measure:** Evaluation of t1/2 of HRS-5346 in plasma **Time Frame:** About three months after the first dose **Measure:** Evaluation of CL/F of HRS-5346 in plasma **Time Frame:** About three months after the first dose **Measure:** Evaluation of Vz/F of HRS-5346 in plasma **Time Frame:** About three months after the first dose **Measure:** Evaluation of Ae of HRS-5346 in urine **Time Frame:** About three months after the first dose **Measure:** Evaluation of fe of HRS-5346 in urine **Time Frame:** About three months after the first dose **Measure:** Evaluation of CLR of HRS-5346 in urine **Time Frame:** About three months after the first dose ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Understand the specific process of the test, voluntarily participate in this test, and sign the informed consent in writing. 2. Age ≥ 18 and ≤ 55 years old on the day of signing the informed consent (including boundary value). 3. Male subjects weigh ≥ 50 kg, female subjects weigh ≥ 45kg, and BMI is in the range of 19\~30 kg/m2 (including boundary values). 4. Subjects (including partners) are willing to voluntarily take effective contraceptive measures within 6 months from the time of signing the informed consent form to the last time the drug is given; the female subject's blood pregnancy test must be negative and non-lactation. 5. Normal or abnormality such as vital signs, physical examination and laboratory examination have no clinical significance. Exclusion Criteria: 1. Those who suffer from any serious clinical diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities, or any other disease or medical history that can interfere with the test results or any significant laboratory abnormality that is judged by researchers to be of clinical significance. 2. Previous history of malignant tumors. 3. Those who have taken any prescription drugs, over-the-counter drugs and Chinese herbs within 14 days before taking the study drug, or within 5 half-life of the drug at the time of screening; those who plan to take non-study drugs during the trial period. 4. Those who have participated in the clinical trial of any drug or medical device within 3 months before screening, or have not been within 5 half-life of the drug before screening (when both standards are met, the standard shall be based on the long-term standard). 5. Subjects received siRNA in the past 12 months, or antisense oligonucleotide drugs in the past six months. 6. The abnormal upper limit of hypersensitive C-reactive protein during the screening period is \>1.5 times the normal upper limit, or the normal upper limit of prothrombin time/international standard ratio (PT/INR), activated partial thrombin time (aPTT) \> 1.25 times normal upper limit. 7. Screening for infectious diseases during the screening period (including hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, syphilis spirochete antibody). 8. 12-lead electrocardiogram abnormal and clinical significance, or electrocardiogram QT interval (QTcF) male \> 450 ms, female \> 470 ms. 9. The total amount of blood donated or blood loss ≥ 200 mL within 1 month before administration, or the total amount of blood donation or blood loss ≥ 400 mL within 3 months before administration, or received blood transfusion within 8 weeks. 10. Those who have a serious infection, serious trauma or major surgery within 3 months before administration; those who plan to undergo surgery within two weeks during and after the end of the trial. 11. Suspected people with a history of allergy to research drugs or any ingredients in research drugs, allergies or previous history of serious drug allergies. 12. People who have had blood collection difficulties or cannot tolerate venous punctures in the past, such as needle fainting and blood fainting. 13. Glomerular filtration rate (eGFR) is lower than GFR 60 mL/min/1.73 m2. 14. Smoke an average of ≥ 5 cigarettes per day in the first three months of administration; the average daily intake of alcohol in the first month before administration exceeded 15 grams. 15. Screening and visiting drug screening test is positive or alcohol breath test is positive. 16. Other circumstances in which the researcher believes that the subject is not suitable to participate in this experiment. **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Honghui Wang **Phone:** 0518-82342973 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441214 **Brief Title:** Retrospective-prospective Study to Evaluate Treatment Management and Outcomes of Patients With Waldenström's Macroglobulinemia (WM) Treated in Italy According to the Zanubrutinib (Brukinsa®) Compassionate Use Program (CUP) and in Common Practice Following Commercial Approval. **Official Title:** Retrospective-prospective Study to Evaluate Treatment Management and Outcomes of Patients With Waldenström's Macroglobulinemia (WM) Treated in Italy According to the Zanubrutinib (Brukinsa®) Compassionate Use Program (CUP) and in Common Practice Following Commercial Approval #### Organization Study ID Info **ID:** FIL_BRUCE-ITA #### Organization **Class:** OTHER **Full Name:** Fondazione Italiana Linfomi - ETS ### Status Module #### Completion Date **Date:** 2026-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Fondazione Italiana Linfomi - ETS #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a non-interventional, observational, retrospective and prospective multicenter Italian study, to describe treatment management and outcomes of Waldenström's Macroglobulinemia (WM) patients treated according to the Italian Compassionate Use Program (CUP) and receiving zanubrutinib following its commercial approval. ### Conditions Module **Conditions:** - Waldenström's Macroglobulinemia (WM) ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** OTHER #### Enrollment Info **Count:** 125 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All patients with Waldenström's macroglobulinemia enrolled in Pre-Reimbursement Access Program (PRAP) of Zanubrutinib, as per Compassionate Use Program (CUP) of Zanubrutinib, and patients treated with commercial drug (Brukinsa®) from PRAP closure to the study start. **Label:** Retrospective cohort #### Arm Group 2 **Description:** Patients with Waldenström's macroglobulinemia treated with Zanubrutinibin clinical practice enrolled from the study start up to 12 months. **Intervention Names:** - Drug: Zanubrutinib **Label:** Prospective cohort ### Interventions #### Intervention 1 **Arm Group Labels:** - Prospective cohort **Description:** Patients will be treated with Zanubrutinib as per routine clinical practice. **Name:** Zanubrutinib **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Cumulative incidence of treatment discontinuation due to toxicity **Measure:** Cumulative incidence of treatment discontinuation due to toxicity **Time Frame:** From the date of first zanubrutinib administration to the date of definitive treatment discontinuation or dose reduction for any cause or death from any cause, from october 2020 up to 24 months since study start #### Secondary Outcomes **Description:** Incidence of adverse events (AEs) **Measure:** Incidence of adverse events (AEs) **Time Frame:** Retrospective cohort: from october 2020 until the study start. Prospective cohort: up to 24 months (duration of study) **Description:** Incidence of adverse events related to zanubrutinib. **Measure:** Incidence of adverse events related to zanubrutinib. **Time Frame:** Retrospective cohort: from october 2020 until the study start. Prospective cohort: up to 24 months (duration of study) **Description:** Incidence of relevant adverse events. **Measure:** Incidence of relevant adverse events. **Time Frame:** Retrospective cohort: from october 2020 until the study start. Prospective cohort: up to 24 months (duration of study) **Description:** Incidence of serious adverse events (SAEs). **Measure:** Incidence of serious adverse events (SAEs). **Time Frame:** Retrospective cohort: from october 2020 until the study start. Prospective cohort: up to 24 months (duration of study) **Description:** Incidence of adverse events leading to death. **Measure:** Incidence of adverse events leading to death. **Time Frame:** Retrospective cohort: from october 2020 until the study start. Prospective cohort: up to 24 months (duration of study) **Description:** Incidence of adverse events leading to treatment discontinuation. **Measure:** Incidence of adverse events leading to treatment discontinuation. **Time Frame:** Retrospective cohort: from october 2020 until the study start. Prospective cohort: up to 24 months (duration of study) **Description:** Incidence of adverse events leading to dose reduction/interruption. **Measure:** Incidence of adverse events leading to dose reduction/interruption. **Time Frame:** Retrospective cohort: from october 2020 until the study start. Prospective cohort: up to 24 months (duration of study) **Description:** Time to first onset of relevant adverse event. **Measure:** Time to first onset of relevant adverse event. **Time Frame:** Retrospective cohort: from october 2020 until the study start. Prospective cohort: up to 24 months (duration of study) **Description:** AEs ≥ G3 Hematological and non-hematological. **Measure:** AEs ≥ G3 Hematological and non-hematological. **Time Frame:** Retrospective cohort: from october 2020 until the study start. Prospective cohort: up to 24 months (duration of study) **Description:** Impact of patients' characteristics and comorbidities on G3 or higher AEs and relevant adverse events development. **Measure:** Impact of patients' characteristics and comorbidities on G3 or higher AEs and relevant adverse events development. **Time Frame:** Retrospective cohort: from october 2020 until the study start. Prospective cohort: up to 24 months (duration of study) **Description:** Frequency of transformation of WM to an aggressive lymphoma and frequency of secondary malignancies. **Measure:** Frequency of transformation of WM to an aggressive lymphoma and frequency of secondary malignancies. **Time Frame:** Retrospective cohort: from october 2020 until the study start. Prospective cohort: up to 24 months (duration of study) **Description:** Major response rate (MRR) (≥PR) (best reported response). **Measure:** Major response rate (MRR) **Time Frame:** Retrospective cohort: from october 2020 until the study start. Prospective cohort: up to 24 months (duration of study) **Description:** Overall response rate (ORR, defined as MRR plus minor response rate) **Measure:** Overall response rate (ORR) **Time Frame:** Retrospective cohort: from october 2020 until the study start. Prospective cohort: up to 24 months (duration of study) **Description:** Best response (best reported response). **Measure:** Best response **Time Frame:** Retrospective cohort: from october 2020 until the study start. Prospective cohort: up to 24 months (duration of study) **Description:** Progression-free survival (PFS) including 6, 12, and 24-month PFS rate **Measure:** Progression-free survival (PFS) **Time Frame:** Retrospective cohort: from october 2020 until the study start. Prospective cohort: up to 24 months (duration of study) **Description:** Overall survival (OS) including 6, 12, and 24-month OS rate. **Measure:** Overall survival (OS) **Time Frame:** Retrospective cohort: from october 2020 until the study start. Prospective cohort: up to 24 months (duration of study) **Description:** Time to treatment failure (any treatment definitive discontinuation, incl. patient or investigator decision, toxicity, progression or death). **Measure:** Time to treatment failure **Time Frame:** Retrospective cohort: from october 2020 until the study start. Prospective cohort: up to 24 months (duration of study) **Description:** Duration of response (DOR) **Measure:** Duration of response (DOR) **Time Frame:** Retrospective cohort: from october 2020 until the study start. Prospective cohort: up to 24 months (duration of study) **Description:** Change of IgM levels until end of zanubrutinib treatment. **Measure:** Change of IgM levels until end of zanubrutinib treatment. **Time Frame:** Retrospective cohort: from october 2020 until the study start. Prospective cohort: up to 24 months (duration of study) **Description:** Impact of patients and disease characteristics, and biomarker test results (MYD88 and CXCR4, if available) on treatment response. **Measure:** Impact of patients and disease characteristics, and biomarker test results (MYD88 and CXCR4, if available) on treatment response. **Time Frame:** Retrospective cohort: from october 2020 until the study start. Prospective cohort: up to 24 months (duration of study) **Description:** Hospital stays comprises all planned and unplanned hospitalizations as well as emergency unit visits, regardless of whether there is an association with WM or not. All hospitalizations and emergency unit visits that started during therapy with zanubrutinib will be considered for hospital stays. **Measure:** Hospital stays **Time Frame:** Retrospective cohort: from october 2020 until the study start. Prospective cohort: up to 24 months (duration of study) **Description:** Quality of life (QoL) assessed with EORTC-QLQ-C30 questionnaire **Measure:** EORTC-QLQ-C30 **Time Frame:** Prospective cohort: up to 24 months (duration of study) **Description:** Quality of life (QoL) assessed with EQ-5D-5L questionnaire **Measure:** EQ-5D-5L **Time Frame:** Prospective cohort: up to 24 months (duration of study) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Signed and dated informed consent form * Waldenström's macroglobulinemia diagnosis in need of treatment according to ESMO (European Society for Medical Oncology) guideline 2018 * Patients who received Zanubrutinib according to the Italian CUP or in common practice following Zanubrutinib commercial approval * Treatment with zanubrutinib according to current SmPC (Summary of Product Characteristics) * Treatment decision before inclusion into this non-interventional study * Age ≥18 years Exclusion Criteria: * Contraindications according to SmPC for patients with WM * Participation in an interventional clinical trial during zanubrutinib treatment * Patients with disease progression during a BTKi treatment (if pre-treated with BTK, only those intolerants are considered eligible) **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with Waldenström's Macroglobulinemia (WM) treated in Italy according to the Zanubrutinib (Brukinsa®) compassionate use program (CUP) and in common practice following commercial approval. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Samantha Dattoli **Phone:** +390599769916 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Iolanda De Martino **Phone:** +390131033153 **Role:** CONTACT #### Locations **Location 1:** **City:** Alessandria **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Gioacchino Catania - **Role:** CONTACT **Country:** Italy **Facility:** A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C.D.U. Ematologia **Location 2:** **City:** Ancona **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Guido Gini - **Role:** CONTACT **Country:** Italy **Facility:** A.O.U. Ospedali Riuniti - Clinica di Ematologia **Location 3:** **City:** Ascoli Piceno **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Piero Galieni - **Role:** CONTACT **Country:** Italy **Facility:** Ospedale C. e G. Mazzoni - U.O.C. di Ematologia **Location 4:** **City:** Bari **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Pellegrino Musto - **Role:** CONTACT **Country:** Italy **Facility:** AOU Policlinico Consorziale - U.O. Ematologia con Trapianto **Location 5:** **City:** Biella **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Annarita Conconi - **Role:** CONTACT **Country:** Italy **Facility:** Nuovo Ospedale degli Infermi - SSD Ematologia **Location 6:** **City:** Bologna **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Pier Luigi Zinzani - **Role:** CONTACT **Country:** Italy **Facility:** Policlinico S. Orsola-Malpighi - Istituto di Ematologia "Seragnoli" **Location 7:** **City:** Bolzano **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Gloria Turri - **Role:** CONTACT **Country:** Italy **Facility:** Ospedale Centrale di Bolzano - Divisione di Ematologia e T.M.O. **Location 8:** **City:** Catania **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Vittorio Del Fabro - **Role:** CONTACT **Country:** Italy **Facility:** Azienda Ospedaliera Universitaria Policlinico - S. Marco - UOC di Ematologia **Location 9:** **City:** Ferrara **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Giulia Daghia - **Role:** CONTACT **Country:** Italy **Facility:** Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna - Ematologia e fisiopatologia della coagulazione **Location 10:** **City:** Firenze **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Benedetta Puccini - **Role:** CONTACT **Country:** Italy **Facility:** Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia **Location 11:** **City:** Genova **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Adalberto Ibatici - **Role:** CONTACT **Country:** Italy **Facility:** Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l'Oncologia - Ematologia e terapie cellulari **Location 12:** **City:** Milano **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Anna Maria Frustaci - **Role:** CONTACT **Country:** Italy **Facility:** ASST Grande Ospedale Metropolitano Niguarda - S.C. Ematologia **Location 13:** **City:** Milano **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Enrico Derenzini - **Role:** CONTACT **Country:** Italy **Facility:** IEO Istituto Europeo di Oncologia - Divisione Ematoncologia **Location 14:** **City:** Milano **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Michele Merli - **Role:** CONTACT **Country:** Italy **Facility:** Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda - Ematologia **Location 15:** **City:** Novara **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Gloria Margiotta Casaluci - **Role:** CONTACT **Country:** Italy **Facility:** AOU Maggiore della Carità di Novara - SCDU Ematologia **Location 16:** **City:** Padova **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Francesco Piazza - **Role:** CONTACT **Country:** Italy **Facility:** AOU di Padova - Ematologia **Location 17:** **City:** Palermo **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Caterina Patti - **Role:** CONTACT **Country:** Italy **Facility:** A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia **Location 18:** **City:** Pavia **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Marzia Varettoni - **Role:** CONTACT **Country:** Italy **Facility:** RCCS Policlinico S. Matteo di Pavia - Div. di Ematologia **Location 19:** **City:** Pescara **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ricciuti Giuseppina - **Role:** CONTACT **Country:** Italy **Facility:** P.O. Spirito Santo di Pescara - UOC Ematologia Dipartimento Oncologico Ematologico - ASL Pescara **Location 20:** **City:** Pisa **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Claudia Barate' - **Role:** CONTACT **Country:** Italy **Facility:** AOU Pisana - U.O. Ematologia **Location 21:** **City:** Ravenna **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Monica Tani - **Role:** CONTACT **Country:** Italy **Facility:** Ospedale delle Croci - Ematologia **Location 22:** **City:** Reggio Emilia **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Angela Ferrari - **Role:** CONTACT **Country:** Italy **Facility:** Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia **Location 23:** **City:** Roma **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Francesco Autore - **Role:** CONTACT **Country:** Italy **Facility:** Università Cattolica Sacro Cuore - Ematologia **Location 24:** **City:** Siena **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Emanuele Cencini - **Role:** CONTACT **Country:** Italy **Facility:** AOU Senese - U.O.C. Ematologia **Location 25:** **City:** Teramo **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Angelo Fama - **Role:** CONTACT **Country:** Italy **Facility:** Ospedale "G. Mazzini" - UOS Ematologia **Location 26:** **City:** Torino **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Simone Ferrero - **Role:** CONTACT **Country:** Italy **Facility:** A.O.U. Città della Salute e della Scienza di Torino - Ematologia Universitaria **Location 27:** **City:** Torino **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Maura Nicolosi - **Role:** CONTACT **Country:** Italy **Facility:** A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia **Location 28:** **City:** Udine **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jacopo Olivieri - **Role:** CONTACT **Country:** Italy **Facility:** Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica #### Overall Officials **Official 1:** **Affiliation:** ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy **Name:** Anna Maria Frustaci **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000054219 - Term: Neoplasms, Plasma Cell - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000020141 - Term: Hemostatic Disorders - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010265 - Term: Paraproteinemias - ID: D000001796 - Term: Blood Protein Disorders - ID: D000006402 - Term: Hematologic Diseases - ID: D000006474 - Term: Hemorrhagic Disorders - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000008206 - Term: Lymphatic Diseases - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11251 - Name: Waldenstrom Macroglobulinemia - Relevance: HIGH - As Found: Waldenstrom Macroglobulinemia - ID: M27588 - Name: Neoplasms, Plasma Cell - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M21977 - Name: Hemostatic Disorders - Relevance: LOW - As Found: Unknown - ID: M5059 - Name: Blood Coagulation Disorders - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M13178 - Name: Paraproteinemias - Relevance: LOW - As Found: Unknown - ID: M5077 - Name: Blood Protein Disorders - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M9560 - Name: Hemorrhagic Disorders - 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: T5887 - Name: Waldenstrom Macroglobulinemia - Relevance: HIGH - As Found: Waldenstrom Macroglobulinemia ### Condition Browse Module - Meshes - ID: D000008258 - Term: Waldenstrom Macroglobulinemia ### Intervention Browse Module - Ancestors - ID: D000092004 - Term: Tyrosine Kinase Inhibitors - ID: D000047428 - Term: Protein Kinase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M42199 - Name: Zanubrutinib - Relevance: HIGH - As Found: Mobile Health - ID: M2889 - Name: Tyrosine Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M25820 - Name: Protein Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: T22 - Name: Tyrosine - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000629551 - Term: Zanubrutinib ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441201 **Brief Title:** Acute Gastrointestinal Bleeding Peripheral Pulse Volume Changes **Official Title:** Peripheral Pulse Volume Changes in Acute Gastrointestinal Bleeding #### Organization Study ID Info **ID:** 23-005579 #### Organization **Class:** OTHER **Full Name:** Mayo Clinic ### Status Module #### Completion Date **Date:** 2024-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** ENROLLING_BY_INVITATION #### 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:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mayo Clinic #### Responsible Party **Investigator Affiliation:** Mayo Clinic **Investigator Full Name:** Andrew C. Storm **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose and aim of this study are to compare changes in pulse volume to non-invasively predict active bleeding or high-risk stigmata in patients undergoing a gastrointestinal endoscopy to assess feasibility of the flow meter clinically. **Detailed Description:** The maximum change in volume of a limb segment during the cardiac cycle - pulse volume - will be monitored non-invasively along with standard vitals in patients with a suspected gastrointestinal bleed undergoing endoscopy. Pulse volume and vitals will be collected prior to and following endoscopy up to the point of dismissal from the endoscopy unit so that the data may be correlated with the endoscopic and clinical findings. ### Conditions Module **Conditions:** - GastroIntestinal Bleeding ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subject undergoing an emergency endoscopic evaluation for active gastrointestinal bleeding will have their peripheral pulse volumes monitored using a pulse flowmeter throughout the procedure and 2 hours after the procedure. **Intervention Names:** - Diagnostic Test: Pulse flowmeter **Label:** Gastrointestinal Bleeding Peripheral Pulse Volume ### Interventions #### Intervention 1 **Arm Group Labels:** - Gastrointestinal Bleeding Peripheral Pulse Volume **Description:** Measures peripheral pulse volumes by an electrode applied non-invasively to the lower extremity (left or right) at the beginning of the endoscopic evaluation for the duration of the procedure, and up to 2 hours after the completion of the procedure. **Name:** Pulse flowmeter **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Peripheral pulse volume as measured by pulse flowmeter (uL/cm) pre and post endoscopic evaluation **Measure:** Changes in peripheral pulse volume with and without active bleeding **Time Frame:** Baseline, approximately 2 hours post endoscopy ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: - Adults (age \>18yr) undergoing emergent endoscopy for active GI bleeding. Exclusion Criteria: * Patients with pre-existing heart failure (ejection fraction \<40%), cardiac rhythm abnormalities and peripheral vascular disease. * Patients with underlying implanted cardiac electrical devices and spinal cord stimulators. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Subjects undergoing emergent endoscopic evaluation for active gastrointestinal bleeding at Mayo Clinic, Rochester, Minnesota. ### Contacts Locations Module #### Locations **Location 1:** **City:** Rochester **Country:** United States **Facility:** Mayo Clinic Minnesota **State:** Minnesota **Zip:** 55905 #### Overall Officials **Official 1:** **Affiliation:** Mayo Clinic **Name:** Andrew Storm, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - 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: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9556 - Name: Hemorrhage - Relevance: HIGH - As Found: Bleeding - ID: M9557 - Name: Gastrointestinal Hemorrhage - Relevance: HIGH - As Found: Gastrointestinal Bleeding - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006471 - Term: Gastrointestinal Hemorrhage - ID: D000006470 - Term: Hemorrhage ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441188 **Brief Title:** Sonography of the Nipple Areolar Complex **Official Title:** Sonography of the Nipple Areolar Complex (SONAC) Study #### Organization Study ID Info **ID:** 24-004909 #### Organization **Class:** OTHER **Full Name:** Mayo Clinic ### Status Module #### Completion Date **Date:** 2025-03-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-02-28 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mayo Clinic #### Responsible Party **Investigator Affiliation:** Mayo Clinic **Investigator Full Name:** Christine U. Lee **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to determine ultrasound scanning techniques of the nipple areolar complex (NAC) that provide optimal diagnostic imaging features. ### Conditions Module **Conditions:** - Healthy **Keywords:** - Nipple ultrasound imaging ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** SCREENING #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Healthy volunteers with no breast cancer or breast symptoms. Subjects will undergo 1 hour of non-invasive ultrasound scanning of the nipple and its adjacent tissues. **Intervention Names:** - Diagnostic Test: Thin layer conventional ultrasound coupling gel - Diagnostic Test: Thick layer of conventional ultrasound coupling gel - Diagnostic Test: Thin conventional ultrasound coupling gel pad - Diagnostic Test: Thick conventional ultrasound coupling gel pad **Label:** Healthy Subjects **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Healthy Subjects **Description:** The GE Logiq E10 ultrasound scanner and the ML6-15 linear probe will be used to collect B-mode images of the nipple-areolar complex following routine clinical imaging practice, using a thin layer of conventional ultrasound coupling gel. **Name:** Thin layer conventional ultrasound coupling gel **Type:** DIAGNOSTIC_TEST #### Intervention 2 **Arm Group Labels:** - Healthy Subjects **Description:** The GE Logiq E10 ultrasound scanner and the ML6-15 linear probe will be used to collect B-mode images of the nipple-areolar complex following routine clinical imaging practice, using a thick layer of conventional ultrasound coupling gel. **Name:** Thick layer of conventional ultrasound coupling gel **Type:** DIAGNOSTIC_TEST #### Intervention 3 **Arm Group Labels:** - Healthy Subjects **Description:** The GE Logiq E10 ultrasound scanner and the ML6-15 linear probe will be used to collect B-mode images of the nipple-areolar complex following routine clinical imaging practice, using a thin conventional ultrasound coupling gel pad. **Name:** Thin conventional ultrasound coupling gel pad **Type:** DIAGNOSTIC_TEST #### Intervention 4 **Arm Group Labels:** - Healthy Subjects **Description:** The GE Logiq E10 ultrasound scanner and the ML6-15 linear probe will be used to collect B-mode images of the nipple-areolar complex following routine clinical imaging practice, using a thick conventional ultrasound coupling gel pad. **Name:** Thick conventional ultrasound coupling gel pad **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Images will be ranked by three independent radiologists and scored from 1 to 4 respectively (1 is the least satisfactory, 4 is the most satisfactory). **Measure:** Image quality satisfaction **Time Frame:** Baseline #### Secondary Outcomes **Description:** The total number of minutes ultrasound is performed on the subjects. **Measure:** Ultrasound exam length of time **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Female, Age of 18 or older; no breast cancer; no breast symptom. Exclusion Criteria: Subjects lacking capacity to consent; vulnerable subjects such as prisoners. Note: Other protocol defined Inclusion/Exclusion Criteria may apply. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Rochester **Country:** United States **Facility:** Mayo Clinic in Rochester **State:** Minnesota **Zip:** 55905 #### Overall Officials **Official 1:** **Affiliation:** Mayo Clinic **Name:** Christine Lee, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Mayo Clinic **Name:** Shigao Chen, 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:** NCT06441175 **Brief Title:** Effectiveness of Cricoid Pressure During Videolaryngoscopy Versus Direct Laryngoscopy **Official Title:** Comparison of the Effectiveness of Cricoid Pressure on Upper Esophageal Obstruction During Videolaryngoscopy Versus Direct Laryngoscopy: a Randomized, Crossover Study #### Organization Study ID Info **ID:** CP during videolaryngoscopy #### Organization **Class:** OTHER **Full Name:** Seoul National University Hospital ### Status Module #### Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-28 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** SMG-SNU Boramae Medical Center #### Lead Sponsor **Class:** OTHER **Name:** Seoul National University Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Compare the success rate of upper esophageal obstruction with cricoid pressure during videolaryngoscopy and direct laryngoscopy. **Detailed Description:** Even with appropriate cricoid pressure, the lifting force of the laryngoscope during direct laryngoscopy for tracheal intubation may counteract the cricoid pressure, making esophageal obstruction ineffective. Compared to direct laryngoscopy, videolaryngoscopy requires less lifting force, and thus, the success rate of esophageal obstruction may be higher. This study aims to compare the success rate of upper esophageal obstruction with cricoid pressure during videolaryngoscopy and direct laryngoscopy. ### Conditions Module **Conditions:** - Cricoid Pressure ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 140 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** the group that performs direct laryngoscopy first and then videolaryngoscopy **Intervention Names:** - Other: Intubation device order **Label:** D-V group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** the group that performs videolaryngoscopy first and then directlaryngoscopy **Intervention Names:** - Other: Intubation device order **Label:** V-D group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - D-V group - V-D group **Description:** D-V group: the group that performs direct laryngoscopy first and then videolaryngoscopy. V-D group: the group that performs video laryngoscopy first and then directlaryngoscopy." **Name:** Intubation device order **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Success rate of esophageal obstruction during cricoid pressure **Measure:** Success rate of esophageal obstruction during cricoid pressure **Time Frame:** During general anesthesia induction #### Secondary Outcomes **Description:** Esophageal diameter measured by ultrasound **Measure:** Esophageal diameter **Time Frame:** During cricoid pressure **Description:** percentage of glottic opening **Measure:** percentage of glottic opening score **Time Frame:** During cricoid pressure **Description:** views obtained by laryngoscopy **Measure:** Cormack-Lehane grade **Time Frame:** During cricoid pressure ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult patients scheduled to have general anesthesia with tracheal intubation Exclusion Criteria: * Gastroesophageal reflux disease, achalasia, bowel obstruction, * BMI \> 35 kg/m2 * Uncontrolled diabetes * Pregnancy * Previous esophageal, and gastric surgery * Dental damage or anticipated difficult airways * Who do not consent to the study **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** TAE KYONG KIM **Phone:** 82-2-870-2519 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** SMG-SNU Boramae Medical Center **Name:** TAE KYONG KIM **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441162 **Brief Title:** Efficacy Of Combined Nebulized Hypertonic Saline and Chest Percussion Therapy in Acute Viral Bronchiolitis **Official Title:** A Pilot, Non-randomized, Single-site Clinical Study Investigating the Efficacy of Combined Therapy of Nebulized 3% Hypertonic Saline and Chest Percussion Therapy in Pediatric Patients With Acute Viral Bronchiolitis. #### Organization Study ID Info **ID:** 23-01357 #### Organization **Class:** OTHER **Full Name:** NYU Langone Health ### Status Module #### Completion Date **Date:** 2025-05-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** NYU Langone Health #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study will examine the efficacy of combined nebulized hypertonic saline with chest percussion therapy in patients age 0 to 24 months admitted to the general inpatient pediatrics unit with acute bronchiolitis. 3% nebulized hypertonic saline treatments combined with 3 minutes of chest percussion therapy will be administered every 6 hours of patients selected for the study. ### Conditions Module **Conditions:** - Acute Bronchiolitis **Keywords:** - acute bronchiolitis - nebulized hypertonic saline - chest percussion therapy ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 114 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants with acute viral bronchiolitis will receive 3% nebulized hypertonic saline treatments combined with 3 minutes of chest percussion therapy. This will be administered every 6 hours. **Intervention Names:** - Drug: Nebulized 3% sodium chloride solution - Device: Chest percussion cups **Label:** Nebulized Hypertonic Saline + Chest Percussion Therapy **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants in the control arm will be analyzed via retrospective chart review; these participants will not be consented nor enrolled in the trial. **Label:** Control Arm **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Nebulized Hypertonic Saline + Chest Percussion Therapy **Description:** Standardized dose of nebulized 3% sodium chloride will be provided from 4 mL vial and administered be every 6 hours. **Name:** Nebulized 3% sodium chloride solution **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Nebulized Hypertonic Saline + Chest Percussion Therapy **Description:** The chest percussion cup is a small, flexible cup made of vinyl that is used to provide gentle chest wall vibrations to assist with airway clearance and is utilized in patients of all ages with sputum production, such as those with acute bronchiolitis. Administered every 6 hours while on supplemental oxygen therapy. **Name:** Chest percussion cups **Other Names:** - MC-2247 Pediatric Manual Percussor Cup **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Measured in days from from time of admission to the general inpatient pediatrics unit until time of discharge from the general inpatient pediatrics unit. **Measure:** Length of Hospital Stay **Time Frame:** Up to time of discharge (Approximately 1-5 days on average) **Description:** Measured in days from from time of admission to the general inpatient pediatrics unit until time of discharge from the general inpatient pediatrics unit. **Measure:** Time on Supplemental Oxygen Support **Time Frame:** Up to time of discharge (Approximately 1-5 days on average) #### Secondary Outcomes **Description:** Assessed every 4 hours and as needed in addition. **Measure:** Average Respiratory Rate **Time Frame:** Up to time of discharge (Approximately 1-5 days on average) **Description:** Assessed every 4 hours and as needed in addition. **Measure:** Average Heart Rate **Time Frame:** Up to time of discharge (Approximately 1-5 days on average) **Description:** Assessed every 4 hours and as needed in addition. **Measure:** Average Pulse Oximetry Reading **Time Frame:** Up to time of discharge (Approximately 1-5 days on average) **Description:** Caregivers will be given a survey in which they will rate their child's overall response following the treatments as "Improved," "Unchanged," or "Worsened." **Measure:** Number of Caregivers who Rate Child's Response as "Improved" **Time Frame:** Time of discharge (Approximately 1-5 days on average) **Description:** Caregivers will be given a survey in which they will rate their child's overall response following the treatments as "Improved," "Unchanged," or "Worsened." **Measure:** Number of Physicians who Rate Child's Response as "Improved" **Time Frame:** Time of discharge (Approximately 1-5 days on average) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: In order to be eligible to participate in this study (experimental arm), an individual must meet all of the following criteria: * Age 0 to 24 months * Admitted to the general inpatient pediatrics unit * Has a diagnosis of acute bronchiolitis * Receiving supplemental oxygen support Data collected for the control arm will be obtained via retrospective chart review for patients meeting the following inclusion criteria: * Age 0 to 24 months * Admitted to the general inpatient pediatrics unit * Has a diagnosis of acute bronchiolitis * Receiving supplemental oxygen support Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: * Admitted to the pediatric intensive care unit * Has an underlying pre-existing condition that may affect the respiratory system (includes bronchopulmonary dysplasia, reactive airways disease, asthma, restrictive lung diseases, other chronic lung diseases, etc.) * Has other comorbid conditions upon admission that may affect the respiratory system (includes pneumonia or other bacterial or fungal lung infections, acute exacerbation of reactive airways disease, acute exacerbation of asthma, pulmonary edema, pleural effusion, etc.) * Has an absolute contraindication to nebulized 3% hypertonic saline, for example, a history of an allergic or anaphylactic reaction * Is receiving other respiratory treatments such as bronchodilator treatments (i.e. albuterol or levalbuterol) * Is receiving other adjuvant therapy such as antibiotics, antivirals, glucocorticoids, corticosteroids, or diuretics A potential study subject in the control arm via retrospective chart review who meets any of the following criteria will be excluded from this study: * Admitted to the pediatric intensive care unit * Has an underlying pre-existing condition that may affect the respiratory system (includes bronchopulmonary dysplasia, reactive airways disease, asthma, restrictive lung diseases, other chronic lung diseases, etc.) * Has other comorbid conditions upon admission that may affect the respiratory system (includes pneumonia or other bacterial or fungal lung infections, acute exacerbation of reactive airways disease, acute exacerbation of asthma, pulmonary edema, pleural effusion, etc.) * Has an absolute contraindication to nebulized 3% hypertonic saline, for example, a history of an allergic or anaphylactic reaction * Is receiving other respiratory treatments such as bronchodilator treatments (i.e. albuterol or levalbuterol) * Is receiving other adjuvant therapy such as antibiotics, antivirals, glucocorticoids, corticosteroids, or diuretics **Maximum Age:** 24 Months **Minimum Age:** 0 Months **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Tuan Nguyen **Phone:** 405-535-7093 **Role:** CONTACT #### Locations **Location 1:** **City:** Mineola **Country:** United States **Facility:** NYU Langone Health **State:** New York **Zip:** 11501 #### Overall Officials **Official 1:** **Affiliation:** NYU Langone Health **Name:** Tuan Nguyen **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to [email protected]. To gain access, data requestors will need to sign a data access agreement. **Description:** The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Tuan Nguyen [email protected] 405-535-7093 The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES **Time Frame:** Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001991 - Term: Bronchitis - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000001982 - Term: Bronchial Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000008171 - Term: Lung Diseases - ID: D000014777 - Term: Virus Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5264 - Name: Bronchiolitis - Relevance: HIGH - As Found: Bronchiolitis - ID: M5266 - Name: Bronchiolitis, Viral - Relevance: HIGH - As Found: Viral Bronchiolitis - ID: M5267 - Name: Bronchitis - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M5258 - Name: Bronchial Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001988 - Term: Bronchiolitis - ID: D000001990 - Term: Bronchiolitis, Viral ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441149 **Brief Title:** Individualized Data-based High Simulation of Bronchoscopy Operations in Preoperative Bronchoscopy Informed Consent **Official Title:** The Impact of a Personalized Data-Based Bronchoscopy Simulation Operation System on Perioperative Anxiety and Satisfaction in Bronchoscopy：a Randomised Controlled Trial #### Organization Study ID Info **ID:** 2024-AI-informed consent #### Organization **Class:** OTHER **Full Name:** China-Japan Friendship Hospital ### Status Module #### Completion Date **Date:** 2024-08-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-07-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-14 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** China-Japan Friendship Hospital #### Responsible Party **Investigator Affiliation:** China-Japan Friendship Hospital **Investigator Full Name:** Gang Hou **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** A prospective randomized controlled study was conducted to investigate whether preoperative replacement of patients based on AI training instruments could alleviate preoperative anxiety. Patients who met the criteria were randomly assigned to either the personalized data-based group or the control group. Prior to the preoperative account examination, each patient's anxiety level was assessed, after which a 30-40-minute informed consent form was read. The traditional group underwent a preoperative account and question-and-answer session with an experienced bronchoscopy laboratory physician, after which the scale was reassessed. The experimental group underwent a simulated surgical procedure on an AI simulation instrument based on the patient's CT personalized data, performed by an experienced bronchoscopist. The bronchoscopist explained the surgical precautions and answered the patient's questions throughout the procedure. Following the responses to the questions, the scale was reassessed. Following surgery, patients are invited to complete a satisfaction survey prior to discharge or following the discussion of bronchoscopy findings. ### Conditions Module **Conditions:** - Bronchoscopy **Keywords:** - Communication - Informed Consent - Physician-Patient Relations - AI - bronchoscopy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 122 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** standard informed consent **Intervention Names:** - Other: Standard informed consent **Label:** standard informed consent **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients receiving personalized data-based informed consent procedure before bronchoscopy **Intervention Names:** - Other: AI-based informed consent **Label:** AI-based informed consent **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - AI-based informed consent **Description:** Patients receiving personalized data-based informed consent procedure before bronchoscopy **Name:** AI-based informed consent **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - standard informed consent **Description:** Standard informed consent **Name:** Standard informed consent **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The modified APAIS questionnaire and the VAS scale were employed to assess anxiety levels before and after informed consent. **Measure:** The level of the patient's anxiety **Time Frame:** 1 days before Bronchoscopic procedures #### Secondary Outcomes **Description:** The post-surgical satisfaction questionnaire consisted of four questions on a 5-point Likert scale, with responses ranging from "strongly agree" to "strongly disagree." **Measure:** The level of the patient's satisfication **Time Frame:** 1 days after Bronchoscopic procedures ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * requiring elective bronchoscopy * Older than 18 years Exclusion Criteria: · Dementia, limited speech, or other problems affecting communication **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Gang Hou, MD **Phone:** 010-84205729 **Role:** CONTACT #### Locations **Location 1:** **City:** BeiJing **Country:** China **Facility:** China-Japan Friendship Hospital **State:** Beijing **Zip:** 100029 ## Derived Section ### 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: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441136 **Brief Title:** Characterizing the Impact of Presbyphonia on Social Interaction **Official Title:** Characterizing the Impact of Presbyphonia on Social Interaction #### Organization Study ID Info **ID:** 202307188 #### Organization **Class:** OTHER **Full Name:** University of Iowa ### Status Module #### Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-05 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-03 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-28 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Matthew R. Hoffman #### Responsible Party **Investigator Affiliation:** University of Iowa **Investigator Full Name:** Matthew R. Hoffman **Investigator Title:** Assistant Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to determine if presbyphonia, or voice disorder caused by age-related change in the larynx, is associated with change in social interaction. This proposal investigates the impact of voice impairment in older adults on social interaction, loneliness, social disconnectedness, and depression. A series of questionnaires, voice assessments, and interviews will be performed to improve our understanding of how voice disorders affect older adults and how treatment of voice impairment with voice therapy may improve quality of life. **Detailed Description:** During the study visit, all subjects (including the control group) will be given ten questionnaires asking them to rate their loneliness and quality of life in relation to the changes in their voice. All participants will undergo audiometry to assess hearing (with hearing aids if used at home). If they do not pass the hearing test, they will be screened out of the study. Participants will then provide a required voice sample using sustained vowels for 3-5 seconds 5 times each, repeating six standard sentences, and 20 seconds of natural conversational speech. Using this voice recording, the following assessments and measurements will be obtained: CAPE-V rating (Consensus auditory perceptual evaluation of voice), Cepstral peak prominence (measurement of dysphonia), fundamental frequency, signal-to-noise ratio, and voice type components (captures breathiness). Subjects will then be asked to produce a train of /pi pi pi/ at a comfortable pitch and loudness into a mask with an intra-oral mouthpiece to record both pressure and airflow. Five trials will be performed. The following measurements will be obtained: mean flow rate, subglottal pressure, and vocal efficiency. Subjects will then undergo an awake videostroboscopy using a small flexible camera passed through the nose to view the vocal folds. During this procedure, the nose is anesthetized and the subject is asked to produce sustained vowels for 3-5 seconds. This part of the study takes about 2 minutes to complete. The parameters to be measured for this are: bowing index of the vocal folds and normalized glottal gap. For the second part of this study, subjects from the presbyphonia population only will be recruited to participate in the phonation resistance training exercises or PhoRTE voice therapy. Prior to therapy, for two weeks, participants will take pictures when their voice disorder may be affecting them or ability to socialize. Brief journal entry will be completed. Photos will be collected, printed, and used as memory recall tool for a pre-treatment semi-structured interview. Interviews will be conducted, approximately 45-60 minutes induration. Both online and in-person options will be available to facilitate participation. An interview guide will include questions designed to assess participants' perception of voice and how voice affects social participation. Subjects will then complete PhoRTE therapy. Participants perform 5 vocal exercises at individualized target vocal intensity. Goals of therapy are to increase muscular workload on vocal mechanism and target the respiratory and laryngeal muscular deficits that result from aging. Participants practice 6 days per week at home and meet with speech pathologist weekly for 4 weeks. Following therapy, participants will participate in 60-75-minute semi-structured small group interviews approximately 3 months after voice therapy. Interviews will address experience with voice therapy, and any changes after voice therapy. ### Conditions Module **Conditions:** - Presbyphonia **Keywords:** - voice therapy - aging voice - voice disorder - speech ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 25 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** PhoRTE is a voice therapy program administered by a speech language pathologist for participants with presbyphonia. During sessions, participants perform five vocal exercises at individualized target vocal intensity. Goals of therapy are to increase muscular workload on vocal mechanism and target the respiratory and laryngeal muscular deficits that result from aging. Participants practice 6 days per week at home and meet with speech pathologist weekly for 4 weeks. **Intervention Names:** - Other: PhoRTE Program - Other: University of California Los Angeles (UCLA) Loneliness Scale - Other: Social Disconnectedness Scale - Other: Patient Health Questionnaire 9 - Other: Aging Voice Index - Other: The Edmonton Frail Scale - Other: Vocal Effort Scale - Other: Montreal Cognitive Assessment - Other: Voice Handicap Index-10 - Other: Voice Problem Impact Scales - Other: Cough Severity Index - Procedure: Laryngoscopy - Other: Acoustic, perceptual, and aerodynamic assessments **Label:** Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program **Description:** Speech therapy program guided by a speech language pathologist. This program includes in person or virtual visits and at home exercises. **Name:** PhoRTE Program **Other Names:** - Speech Therapy Program **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program **Description:** A questionnaire measuring levels of loneliness. **Name:** University of California Los Angeles (UCLA) Loneliness Scale **Other Names:** - UCLA Loneliness Scale **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program **Description:** A questionnaire that asks about social network size and the frequency of social activities attended. **Name:** Social Disconnectedness Scale **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program **Description:** A questionnaire measuring levels of depression. **Name:** Patient Health Questionnaire 9 **Other Names:** - PHQ-9 **Type:** OTHER #### Intervention 5 **Arm Group Labels:** - Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program **Description:** A questionnaire of patient-reported voice outcome measures designed to capture the quality of life impact of dysphonia in older adults. **Name:** Aging Voice Index **Type:** OTHER #### Intervention 6 **Arm Group Labels:** - Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program **Description:** A questionnaire that measures frailty levels. **Name:** The Edmonton Frail Scale **Type:** OTHER #### Intervention 7 **Arm Group Labels:** - Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program **Description:** A picture based questionnaire scale that asks the subject to rate their perceived effort when using their voice. **Name:** Vocal Effort Scale **Type:** OTHER #### Intervention 8 **Arm Group Labels:** - Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program **Description:** A screening tool used to test for cognitive impairment. **Name:** Montreal Cognitive Assessment **Other Names:** - MOCA **Type:** OTHER #### Intervention 9 **Arm Group Labels:** - Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program **Description:** A questionnaire used to measure quality of life impact of dysphonia. **Name:** Voice Handicap Index-10 **Other Names:** - VHI-10 **Type:** OTHER #### Intervention 10 **Arm Group Labels:** - Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program **Description:** A 4 question survey that captures impact of voice on four domains - work/daily activities, social life, home, and overall quality of life. **Name:** Voice Problem Impact Scales **Other Names:** - VPIS **Type:** OTHER #### Intervention 11 **Arm Group Labels:** - Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program **Description:** A 10 question survey asking to rate severity of cough. **Name:** Cough Severity Index **Type:** OTHER #### Intervention 12 **Arm Group Labels:** - Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program **Description:** Nose is anesthetized and a flexible endoscope is passed to visualize the larynx at rest and during sustained vowel production (/i/) for 3-5 seconds. This will be used to measure bowing index and normalized glottal gap of the vocal folds. **Name:** Laryngoscopy **Other Names:** - Flexible transnasal videostroboscopy **Type:** PROCEDURE #### Intervention 13 **Arm Group Labels:** - Phonation Resistance Training Exercises (PhoRTE) Voice Therapy Program **Description:** Participants will complete voice recording tasks including sustained vowel production, six standard sentences, and 20 seconds of natural conversational speech. This will be used to measure CAPE-V rating, Cepstral peak prominence, fundamental frequency, signal-to-noise ratio, voice type components, mean flow rate, subglottal pressure, and vocal efficiency. **Name:** Acoustic, perceptual, and aerodynamic assessments **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Loneliness will be measured using the University of California - Los Angeles (UCLA) Loneliness Scale questionnaire at baseline and at the end of the 4-week PhoRTE program. The UCLA Loneliness Scale is a 20-item scale with each item rated on a 4-point Likert scale (ranging from 1, "never," to 4, "often") and the total score can range from 20 to 80, with higher scores indicating greater feelings of loneliness. **Measure:** The Effect on Loneliness with the PhoRTE Voice Therapy Program **Time Frame:** Baseline and at 3 months #### Secondary Outcomes **Description:** Social disconnectedness will be measured using the Social Disconnectedness Scale questionnaire at baseline and at the end of the 4 week PhoRTE program. The Social Disconnectedness Scale is based on a 15-item scale with each item rated on their own scale depending on the question asked (ex: ranging from 0, "never" to 7, "several times a week" or indicating number of individuals in a social network). The total score can range from 2 to 72, with lower scores indicating greater levels of social disconnectedness. **Measure:** The Effect on Social Disconnectedness with the PhoRTE Voice Therapy Program **Time Frame:** Baseline and at 3 months **Description:** Levels of depression will be measured using the Patient Health Questionnaire-9 (PHQ-9) at baseline and at the end of the 4 week PhoRTE program. The PHQ-9 is a 9-item scale with each item rated on a scale (ranging from 0, "not at all," to 3, "nearly every day") and the total score can range from 0-27 with higher scores indicating greater feelings of depression. **Measure:** The Effect on Depression with the PhoRTE Voice Therapy Program **Time Frame:** Baseline and at 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosis of presbyphonia with findings of presbylaryngis on videostroboscopy, with findings of bilateral true vocal fold atrophy and normal vocal fold motion bilaterally * Able to complete all questionnaires and voice assessment tasks * Normal to mild hearing loss in aided condition (with hearing aids) Exclusion Criteria: * Liquid dysphagia or pneumonia in the last year * Vocal fold lesion/scar/motion impairment * Neurologic disorder affecting the voice * Montreal cognitive assessment score \<26 or \<25 if 12 or fewer years of formal education **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Matthew R Hoffman, MD, PhD **Phone:** 319-356-2201 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Emma L Thayer, BS **Phone:** 319-678-7518 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** University of Iowa **Name:** Matthew R Hoffman, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** email principal investigator a non-disclosure and/or data usage agreement will most likely be required **Description:** Any data or resources, shared upon request, will be de-identified and released only after appropriate data sharing agreements are completed by the relevant parties. Users must agree to the conditions of use governing access to the public release data. This includes restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, proper acknowledgement of the data resource, information provided to users will not be used for commercial purposes, and will not be redistributed to third parties. **Info Types:** - STUDY_PROTOCOL - SAP - CSR **IPD Sharing:** YES **Time Frame:** after study completion ### References Module #### References **Citation:** Awan SN, Roy N, Dromey C. Estimating dysphonia severity in continuous speech: application of a multi-parameter spectral/cepstral model. Clin Linguist Phon. 2009 Nov;23(11):825-41. doi: 10.3109/02699200903242988. **PMID:** 19891523 **Citation:** Baertsch HC, Bhatt NK, Giliberto JP, Dixon C, Merati AL, Sauder C. Quantification of Vocal Fold Atrophy in Age-Related and Parkinson's Disease-Related Vocal Atrophy. 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Epub 2014 Jan 29. **PMID:** 24375313 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - 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: M17575 - Name: Voice Disorders - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441123 **Acronym:** TatLat **Brief Title:** Development of a New Family of HIV Latency Regulators (LRAs) Targeting the Tat Viral Protein **Official Title:** Development of a New Family of HIV Latency Regulators (LRAs) Targeting the Tat Viral Protein #### Organization Study ID Info **ID:** RECHMPL23_0276 #### Organization **Class:** OTHER **Full Name:** University Hospital, Montpellier ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-03-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-28 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Centre National de la Recherche Scientifique, France **Class:** OTHER **Name:** Université Montpellier #### 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:** Antiretroviral therapy (ART) prevents HIV from multiplying. However, if people living with HIV stop taking ART, the virus quickly reappears in their blood due to the random activation of hidden infected cells. These hidden cells contain HIV that is not active and do not produce the virus. These cells are a major challenge in finding a cure for HIV. One of the most promising ways to get rid of these hidden infected cells is by activating them with special drugs called latency-reversing agents (LRAs). This process, known as the "shock-and-kill" strategy, involves waking up the hidden virus ("shock" phase) so that it can be destroyed by the body's immune system or by the virus itself ("kill" phase). Investigators are developing new LRAs that target and activate a viral protein called Tat, which is necessary for the virus to start producing again and for reversing its dormant state.The lead compound, named D10, is the first of its kind to target the Tat protein. This compound has been patented and has shown activity in activating the virus in lab-grown cells. Now, investigators need to test its effectiveness on real target cells from people living with HIV. **Detailed Description:** 20 ml of blood (5 tubes of 4 ml each) will be collected from 24 people living with HIV who are on ART. The inclusion criteria for this study are: being HIV-positive, having an undetectable viral load for more than 12 months, and having a history of very low T-CD4 counts (nadir \< 200 cells/mm³). In the lab, investigators will isolate immune cells (PBMCs) from the blood using a special technique. These cells will then be placed in small wells and treated with LRAs for 18-20 hours. Investigators will measure the virus produced in the cell supernatant using two methods: q-RT-PCR for viral RNA and p24 ELISA for viral protein. The results will be analyzed using conventional statistical methods. ### Conditions Module **Conditions:** - HIV Infections **Keywords:** - HIV-1 - Tat - latency - latency reversing agents - transcription ### Design Module #### Bio Spec **Description:** 20 ml of blood (5 tubes of 4 ml each) from 24 people living with HIV who are on AntiRetroviral Therapy **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 24 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** 20 ml of blood (5 tubes of 4 ml) will be collected once. **Name:** Blood Sampling **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Viral production is considered significant if the signal obtained from the p24 ELISA of these supernatants is more than twice the background observed in the absence of LRA **Measure:** Quantity of p24 in the cell supernatant 18-20 hours after the addition of the LRAs (Latency Reversing Agents) **Time Frame:** INCLUSION VISIT #### Secondary Outcomes **Description:** quantity of viral RNA in the cell supernatant 18-20 hours after the addition of LRAs. **Measure:** Quantity of viral RNA in the cell supernatant 18-20 hours after the addition of LRAs. **Time Frame:** INCLUSION VISIT **Description:** effective dose of D10 to reverse the latency of latent HIV-infected PBMCs **Measure:** Measure the effective dose of D10 to reverse the latency of latent HIV-infected PBMCs **Time Frame:** INCLUSION VISIT ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patient aged 18 years or older * HIV-positive * On ART (antiretroviral therapy) * HIV-1 RNA undetectable for more than 12 months * Nadir CD4 count \< 200/µL Exclusion Criteria: * Lack of antiretroviral treatment * Immunosuppressive treatments * History of cancer less than 5 years old * Pregnant or breast-feeding women * Persons protected by law (under guardianship or curators), persons under court protection * Participating in another research project with an ongoing exclusion period * Refusal to participate in research * Subject not affiliated to a social security scheme, or not benefiting from such a scheme. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The target population is aviremic HIV-positive individuals, with no age criterion, having a long history of HIV infection (nadir \< 200 CD4/µL ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Alain MAKINSON, Pr **Phone:** 04 67 33 83 40 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Bruno BEAUMELLE **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - 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: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000007153 - Term: Immunologic Deficiency Syndromes - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M18250 - Name: HIV Infections - Relevance: HIGH - As Found: HIV Infections - 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: 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: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - 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: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M10199 - Name: Immunologic Deficiency Syndromes - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015658 - Term: HIV Infections ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441110 **Brief Title:** Multicenter Clinical Trial on the Effectiveness and Safety of Instillation of BCG and Alternative BCG Protocols for Intermediate and High-risk Non-muscle Invasive Bladder Cancer **Official Title:** Multicentre Clinical Trial of the Efficacy and Safety of Tislelizumab in Combination With BCG Bladder Instillation in the Prevention of Postoperative Recurrence in Intermediate and High-risk Non-muscle Invasive Bladder Cancer #### Organization Study ID Info **ID:** 2023XHYG0045-02 #### Organization **Class:** OTHER **Full Name:** Fujian Medical University Union Hospital ### Status Module #### Completion Date **Date:** 2035-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-03 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-06-01 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-06-03 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Fujian Medical University Union Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Previous studies have reported the efficacy of Bacillus Calmette-Guérin (BCG) combined with other drugs for the treatment of bladder cancer. However, research on the combination of tislelizumab and BCG for bladder cancer treatment has largely been retrospective. Currently, ongoing clinical trials have not discussed the effectiveness of PD-1/PD-L1 inhibitors combined with BCG instillation in reducing postoperative recurrence in intermediate-risk NMIBC. Therefore, this study aims to explore the clinical efficacy and safety of tislelizumab combined with BCG in the treatment of intermediate and high-risk NMIBC. For this purpose, investigators have established strict screening criteria to include eligible patients in the study and have recruited suitable patients from multiple medical centers.Investigators have also developed a meticulous implementation process and follow-up considerations, hoping to better verify the clinical efficacy and safety of the combined use of these two drugs. ### Conditions Module **Conditions:** - Urinary Bladder Neoplasms - BCG Vaccine - Immunotherapy, Active - Multicenter Study - Treatment Outcome - Neoplasm Recurrence, Local ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 76 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Tislelizumab in Combination with Bacillus Calmette-Guérin for the Treatment of Intermediate and High-Risk NMIBC Group **Intervention Names:** - Drug: Tislelizumab in Combination with Bacillus Calmette-Guérin **Label:** Postoperative Instillation Therapy Group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Postoperative Instillation Therapy Group **Description:** Postoperative immediate instillation of epirubicin (50mg) is administered. Postoperatively, 200mg of tislelizumab injection is given intravenously every 3 weeks, with each 21-day period constituting one cycle. The medication is administered on day 1 of each cycle, continuing for one year. Eligible patients for the single-arm group (N = 76) begin BCG instillation after 2 weeks, with a dosage of 120mg per instillation, totaling 19 instillations: this starts with a 6-week induction phase of weekly BCG instillations, followed by BCG instillations every 2 weeks for three consecutive times; thereafter, maintenance instillation therapy commences, involving monthly BCG instillations for a total of ten times. **Name:** Tislelizumab in Combination with Bacillus Calmette-Guérin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The time from postoperative cystoscopic examination to the first documented recurrence of bladder tumor. **Measure:** Relapse-Free Survival(RFS) **Time Frame:** From date of postoperative cystoscopic examination to the first documented recurrence of bladder tumor,assessed up to 60 months. #### Secondary Outcomes **Description:** The time recorded from postoperative cystoscopic and pathological examinations to the first progression of bladder tumor, defined in this trial as the occurrence of muscle-invasive growth in NMIBC (Non-Muscle Invasive Bladder Cancer) patients. **Measure:** Progression-Free Survival(PFS) **Time Frame:** From date of postoperative cystoscopic and pathological examinations to the first progression of bladder tumor, assessed up to 60 months. **Description:** The duration from post-surgery to the time of death due to any cause. For participants who are lost to follow-up prior to death, the time of their last follow-up is typically considered as the time of death for calculation purposes. **Measure:** Overall survival **Time Frame:** From date of post-surgery to the time of death due to any cause,assessed up to 60 months **Description:** An adverse event (AE) is defined according to the toxicity grading standards set by the National Cancer Institute of the United States. This includes a spectrum of adverse reactions associated with antineoplastic therapy. Specific grading of adverse reactions refers to the Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) developed by the National Cancer Institute (NCI). **Measure:** Adverse event（AS) **Time Frame:** From date of post-surgery to the time of death due to any cause,assessed up to 60 months. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Voluntary participation in the trial with signed informed consent; 2. Patients aged ≥18 and ≤75 years, regardless of gender, with an expected survival of ≥2 years; 3. Histologically confirmed non-muscle-invasive bladder urothelial carcinoma with positive PD-L1 expression. According to the 2014 guidelines of the Chinese Urological Association (CUA), patients are assessed as having a medium to high risk of recurrence or progression. (For patients considering a second transurethral resection, they may be included in the study after completing the procedure and if pathology confirms medium to high risk non-muscle-invasive bladder urothelial carcinoma); 4. Performance status score (Eastern Cooperative Oncology Group, ECOG) of 0-2; 5. Completion of screening-related examinations (complete blood count, coagulation function, liver and kidney function, infectious disease screening, 12-lead ECG, urinary system ultrasound, pelvic MR, and tissue pathology examination), without surgical contraindications. Exclusion Criteria: 1. Any of the following conditions: Immune deficiency or impairment (such as AIDS patients), current use of immunosuppressive drugs or radiation therapy that may cause systemic BCG disease reaction; allergy to BCG components; patients with fever and acute infectious diseases, including active tuberculosis or those undergoing anti-tuberculosis treatment; those with severe chronic cardiovascular or cerebrovascular diseases or chronic kidney disease; 2. Concurrent urogenital system tumors or tumors in other organs; 3. Muscle-invasive bladder urothelial carcinoma (stage T2 and above) patients; 4. Patients who have received chemotherapy, radiotherapy, or immunotherapy within the past 4 weeks (except immediate postoperative bladder instillation chemotherapy); 5. Pregnant or lactating women, women of childbearing age not using effective contraception, or those planning to conceive during the trial period (including male participant partners); 6. Known or suspected intraoperative bladder perforation; 7. Presence of gross hematuria prior to enrollment, suspected unhealed surgical wounds or damaged urinary mucosa; 8. Severe urethral stricture preventing cystoscopy, history of bladder contracture, or functional bladder volume less than 100mL; 9. Accompanying cystitis, or those who have received other bladder instillation medications and have severe bladder irritation signs expected to affect the assessment of this study; 10. Patients with various mental disorders, severe coagulation function, liver and kidney function, hematopoietic function disorders, etc., that cannot tolerate surgical treatment; 11. Participation in other drug clinical trials within 3 months before enrollment; 12. Known or suspected opioid or alcohol dependence; 13. Any condition that the researcher believes may increase the risk to the participant or interfere with the execution of the clinical trial. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jiabing Zheng **Phone:** +8613799422519 **Role:** CONTACT #### Locations **Location 1:** **City:** Fuzhou **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jiabing Zheng - **Phone:** +8613799422519 - **Role:** CONTACT **Country:** China **Facility:** Department of Urology, Fujian Union Hospital, Fujian Medical University **State:** Fujian **Status:** RECRUITING **Zip:** 350000 #### Overall Officials **Official 1:** **Affiliation:** Department of Urology, Fujian Union Hospital, Fujian Medical University **Name:** Zhenlin Chen **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014571 - Term: Urologic Neoplasms - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000001745 - Term: Urinary Bladder Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009385 - Term: Neoplastic 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 ### Condition Browse Module - Browse Leaves - ID: M14850 - Name: Recurrence - Relevance: HIGH - As Found: Recurrence - ID: M5030 - Name: Urinary Bladder Neoplasms - Relevance: HIGH - As Found: Urinary Bladder Neoplasms - ID: M12309 - Name: Neoplasm Recurrence, Local - Relevance: HIGH - As Found: Neoplasm Recurrence, Local - ID: M2976 - Name: Non-Muscle Invasive Bladder Neoplasms - Relevance: HIGH - As Found: Non-muscle Invasive Bladder Cancer - ID: M17320 - Name: Urologic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M5026 - Name: Urinary Bladder Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M5534 - Name: Carcinoma - 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: M12330 - Name: Neoplastic Processes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms - ID: D000001749 - Term: Urinary Bladder Neoplasms - ID: D000093284 - Term: Non-Muscle Invasive Bladder Neoplasms - ID: D000009364 - Term: Neoplasm Recurrence, Local - ID: D000012008 - Term: Recurrence ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000000276 - Term: Adjuvants, Immunologic - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M137899 - Name: Tislelizumab - Relevance: HIGH - As Found: Intensive Care - ID: M4793 - Name: BCG Vaccine - Relevance: HIGH - As Found: Sharp - ID: M17954 - Name: Epirubicin - Relevance: LOW - As Found: Unknown - ID: M17360 - Name: Vaccines - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M3628 - Name: Adjuvants, Immunologic - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000707970 - Term: Tislelizumab - ID: D000001500 - Term: BCG Vaccine ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441097 **Brief Title:** Efficacy of Pola-RCHP-X vs Pola-RCHP in Untreated DLBCL **Official Title:** A Study to Evaluate the Efficacy and Safety of Genotype-guided Targeted Agents in Combination With POLA-RCHP VERSUS POLA-RCHP in Patients With Previously Untreated Diffuse Large B-cell Lymphoma #### Organization Study ID Info **ID:** GUIDANCE-005 #### Organization **Class:** OTHER **Full Name:** Ruijin Hospital ### Status Module #### Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-02 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-12-31 **Type:** ESTIMATED **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-26 **Study First Submit QC Date:** 2024-06-02 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ruijin Hospital #### Responsible Party **Investigator Affiliation:** Ruijin Hospital **Investigator Full Name:** Zhao Weili **Investigator Title:** M.D **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 purpose of this study is to compare the efficacy and safety of genotype-guided targeted agents in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola RCHP-X) versus Pola RCHP in Chinese patients with previously untreated diffuse large B-cell lymphoma (DLBCL). ### Conditions Module **Conditions:** - Diffuse Large B-Cell Lymphoma ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 152 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day2, rituximab 375 milligrams per square meter (mg/m²) IV on Day 1, cyclophosphamide 750 mg/m² IV on Day 2， doxorubicin 50 mg/m² IV on Day 2 and prednisone 100 milligrams per day (mg/day) orally (PO) on Days 2-6 of every 21-day cycle for the first cycle. For the remaining 5 cycles, they will receive Acalabrutinib 100 mg BID PO on days 1-21, or lenalidomide 25 mg/day PO on days 1-10, or decitabine 10 mg/m²/day IV on days -5 to -1 followed by standard Pola-RCHP of every 21-day cycle. **Intervention Names:** - Drug: Polatuzumab vedotin - Drug: Rituximab - Drug: Cyclophosphamide - Drug: Doxorubicin - Drug: Prednisone - Drug: Acalabrutinib - Drug: Lenalidomide - Drug: Decitabine **Label:** Pola-RCHP-X **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day2, rituximab 375 milligrams per square meter (mg/m²) IV on Day 1, cyclophosphamide 750 mg/m² IV on Day 2， doxorubicin 50 mg/m² IV on Day 2 and prednisone 100 milligrams per day (mg/day) orally (PO) on Days 2-6 of every 21-day cycle for 6 cycles. **Intervention Names:** - Drug: Polatuzumab vedotin - Drug: Rituximab - Drug: Cyclophosphamide - Drug: Doxorubicin - Drug: Prednisone **Label:** Pola-RCHP **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Pola-RCHP - Pola-RCHP-X **Description:** Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm. **Name:** Polatuzumab vedotin **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Pola-RCHP - Pola-RCHP-X **Description:** Rituximab IV infusion will be administered as per the schedule specified in the respective arm. **Name:** Rituximab **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Pola-RCHP - Pola-RCHP-X **Description:** Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm. **Name:** Cyclophosphamide **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Pola-RCHP - Pola-RCHP-X **Description:** Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm. **Name:** Doxorubicin **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - Pola-RCHP - Pola-RCHP-X **Description:** Prednisone PO will be administered as per the schedule specified in the respective arm. **Name:** Prednisone **Type:** DRUG #### Intervention 6 **Arm Group Labels:** - Pola-RCHP-X **Description:** Acalabrutinib PO will be administered as per the schedule specified in the respective arm. **Name:** Acalabrutinib **Type:** DRUG #### Intervention 7 **Arm Group Labels:** - Pola-RCHP-X **Description:** Lenalidomide PO will be administered as per the schedule specified in the respective arm. **Name:** Lenalidomide **Type:** DRUG #### Intervention 8 **Arm Group Labels:** - Pola-RCHP-X **Description:** Decitabine IV infusion will be administered as per the schedule specified in the respective arm. **Name:** Decitabine **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** PFS, defined as the time from randomization to the first occurrence of disease progression or relapse using the 2014 Lugano Response Criteria or death due to any cause, whichever occurs first; as determined by the investigator **Measure:** Progression-free survival（by IRC） **Time Frame:** From randomization to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (up to 24 months) #### Secondary Outcomes **Description:** PFS, defined as the time from randomization to the first occurrence of disease progression or relapse using the 2014 Lugano Response Criteria or death due to any cause, whichever occurs first; as determined by the investigator **Measure:** Progression-free survival（by the investigator） **Time Frame:** From randomization to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (up to 24 months) **Description:** defined as the time from date of randomization to the earliest occurrence of any of the following: * Disease progression/relapse as determined by the investigator and IRC (separately) * Death due to any cause * The primary efficacy reason determined by the investigator, other than disease progression/relapse, that leads to initiation of NALT * If biopsy is obtained after treatment completion and is positive for residual disease regardless of whether NALT is initiated or not **Measure:** Event-free survival **Time Frame:** up to approximately 24 months **Description:** CR rate at the end of treatment by FDG-PET defined as the proportion of participants with CR at the end of treatment according to the 2014 Lugano Response Criteria; as determined by the investigator and IRC (separately) **Measure:** Complete response rate **Time Frame:** End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days] **Description:** ORR at treatment completion or discontinuation defined as the proportion of participants with partial response (PR) or CR at the end of treatment according to the 2014 Lugano Response Criteria; as determined by the investigator and IRC(separately) **Measure:** Objective response rate **Time Frame:** End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days] **Description:** OS defined as the time from randomization to death from any cause **Measure:** Overall survival **Time Frame:** up to approximately 2 years **Description:** An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. **Measure:** Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 **Time Frame:** From enrollment to study completion, a maximum of 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Signed Informed Consent Form * Age 18-75 years at the time of signing Informed Consent Form and willingness to comply with study protocol procedures * Previously untreated participants with CD20-positive DLBCL * IPI score 2-5 * ECOG Performance Status of 0, 1, or 2 * After 1 cycle of Pola-R-CHP, ctDNA decreased by \< 3.0 LFC * Life expectancy ≥ 6 months * Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO) * Adequate hematologic function (unless due to underlying disease, as established for example, by extensive bone marrow involvement or due to hypersplenism secondary to involvement of the spleen by DLBCL per the investigator for which blood product transfusions are permitted) defined as follows: * Hemoglobin ≥ 9.0 g/dL without packed RBC transfusion during 7 days before first treatment * ANC ≥ 1.0 x 10\^9/L * PLT ≥ 75 x 10\^9/L Exclusion Criteria: * Contraindication to any of the individual components of Pola-RCHP or Acalabrutinib/Lenalidomide/ Decitabine * Prior solid organ transplantation or SCT * Current diagnosis of the following: Follicular lymphoma grade 3B; mediastinal grey zone lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; PCNSL * History of other malignancy that could affect compliance with the protocol or interpretation of results * Participants with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix at any time prior to the study are eligible * Participants with low-grade, early-stage prostate cancer (Gleason score 6 or below, Stage 1 or 2) with no requirement for therapy at any time prior to study are eligible * Participants receiving adjuvant endocrine therapy for non-metastatic, hormone receptor-positive breast cancer for ≥ 2 years prior to enrollment are eligible * Participants with any other malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for ≥ 2 years prior to enrollment are eligible * Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 6 months prior to the start of Cycle 1, unstable arrhythmias, or unstable angina * Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. - Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurological deficits, as judged by the investigator, are allowed * History or presence of an abnormal ECG that is clinically significant in the investigator's opinion * History of treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents, as follows: - Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or significant infections within 4 weeks before the start of Cycle 1 * Active autoimmune disease which is not well controlled by therapy * Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone may be eligible * Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study * Participants with active autoimmune disease with dermatologic manifestations are eligible for the study * Participants with a history of autoimmune hepatitis, systemic lupus erythematosus, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, multiple sclerosis, or glomerulonephritis will be excluded * Participants with a history of immune thrombocytopenic purpura, autoimmune hemolytic anemia, Guillain-Barré syndrome, myasthenia gravis, myositis, rheumatoid arthritis, vasculitis, or other autoimmune disease will be excluded unless they have not required systemic therapy in the last 12 months * Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma): * ANC \< 1.0 x 10\^9/L * PLT \< 75 x 10\^9/L * Serum AST and ALT ≥ 2.5 x ULN * Total bilirubin ≥ 1.5 x ULN * Serum creatinine clearance \< 30 mL/min (using Cockcroft-Gault formula) * Any active infection within 7 days prior to Cycle 1 Day 1 that would impact participant safety * Suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay) * Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \[HBsAg\] serology) - Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HbsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. Such participants must be willing to undergo HBV DNA testing every month and appropriate antiviral therapy as indicated * Positive test results for hepatitis C (hepatitis C virus \[HCV\] antibody serology testing) - Participants positive for HCV antibody are eligible only if PCR is negative for HCV RNA * Participants with a history of progressive multifocal leukoencephalopathy * Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 12 months after final dose of Pola-RCHP-X * Other concurrent and uncontrolled medical conditions that, in the opinion of the investigator, would affect the patient's participation in 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:** Weili Zhao **Phone:** +862164370045 **Phone Ext:** 610707 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Pengpeng Xu **Phone:** +862164370045 **Phone Ext:** 610707 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## 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: D000008228 - Term: Lymphoma, Non-Hodgkin ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11220 - Name: Lymphoma - Relevance: HIGH - As Found: Lymphoma - ID: M18828 - Name: Lymphoma, B-Cell - Relevance: HIGH - As Found: B-cell Lymphoma - ID: M18831 - Name: Lymphoma, Large B-Cell, Diffuse - Relevance: HIGH - As Found: Diffuse Large B-Cell Lymphoma - 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: M11222 - Name: Lymphoma, Non-Hodgkin - Relevance: LOW - As Found: Unknown - ID: T3543 - Name: Lymphosarcoma - Relevance: LOW - As Found: Unknown - ID: T640 - Name: B-cell Lymphoma - Relevance: HIGH - As Found: B-cell Lymphoma - ID: T1866 - Name: Diffuse Large B-Cell Lymphoma - Relevance: HIGH - As Found: Diffuse Large B-Cell Lymphoma ### Condition Browse Module - Meshes - ID: D000008223 - Term: Lymphoma - ID: D000016393 - Term: Lymphoma, B-Cell - ID: D000016403 - Term: Lymphoma, Large B-Cell, Diffuse ### Intervention Browse Module - Ancestors - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018501 - Term: Antirheumatic Agents - ID: D000018906 - Term: Antineoplastic Agents, Alkylating - ID: D000000477 - Term: Alkylating Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents - ID: D000019653 - Term: Myeloablative Agonists - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000903 - Term: Antibiotics, Antineoplastic - ID: D000059005 - Term: Topoisomerase II Inhibitors - ID: D000059003 - Term: Topoisomerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000005938 - Term: Glucocorticoids - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000018931 - Term: Antineoplastic Agents, Hormonal - ID: D000020533 - Term: Angiogenesis Inhibitors - ID: D000043924 - Term: Angiogenesis Modulating Agents - ID: D000006133 - Term: Growth Substances - ID: D000006131 - Term: Growth Inhibitors - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000000963 - Term: Antimetabolites - ID: D000092004 - Term: Tyrosine Kinase Inhibitors - ID: D000047428 - Term: Protein Kinase Inhibitors - ID: D000018796 - Term: Immunoconjugates ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M6727 - Name: Cyclophosphamide - Relevance: HIGH - As Found: Cycle - ID: M1697 - Name: Decitabine - Relevance: HIGH - As Found: Marrow - ID: M14121 - Name: Prednisone - Relevance: HIGH - As Found: Outcomes - ID: M373 - Name: Rituximab - Relevance: HIGH - As Found: Healthy - ID: M7492 - Name: Doxorubicin - Relevance: HIGH - As Found: Cognitive - ID: M1725 - Name: Lenalidomide - Relevance: HIGH - As Found: Mg/day - ID: M42185 - Name: Acalabrutinib - Relevance: HIGH - As Found: Varenicline - ID: M289652 - Name: Polatuzumab vedotin - Relevance: HIGH - As Found: Posttraumatic Stress Disorder - ID: M227339 - Name: Liposomal doxorubicin - Relevance: LOW - As Found: Unknown - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: M20942 - Name: Antineoplastic Agents, Alkylating - Relevance: LOW - As Found: Unknown - ID: M3820 - Name: Alkylating Agents - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - 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: M20966 - Name: Antineoplastic Agents, Hormonal - Relevance: LOW - As Found: Unknown - ID: M22318 - Name: Angiogenesis Inhibitors - Relevance: LOW - As Found: Unknown - ID: M9231 - Name: Growth Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown - ID: M2889 - Name: Tyrosine Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M25820 - Name: Protein Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M20855 - Name: Immunoconjugates - Relevance: LOW - As Found: Unknown - ID: T22 - Name: Tyrosine - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000011241 - Term: Prednisone - ID: D000003520 - Term: Cyclophosphamide - ID: D000069283 - Term: Rituximab - ID: D000004317 - Term: Doxorubicin - ID: D000077269 - Term: Lenalidomide - ID: D000077209 - Term: Decitabine - ID: C000604908 - Term: Acalabrutinib - ID: C000600736 - Term: Polatuzumab vedotin ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441084 **Brief Title:** A Trial to Evaluate the Safety and Efficacy of NCR300 in Preventing Recurrence of Acute Myeloid Leukemia（AML) After Transplantation **Official Title:** A Phase I or II Clinical Trial Evaluating the Safety and Efficacy of NCR300 Injection in Preventing Recurrence of Acute Myeloid Leukemia After Allogeneic Blood Stem Cell Transplantation #### Organization Study ID Info **ID:** NCR300-2002 #### Organization **Class:** INDUSTRY **Full Name:** Nuwacell Biotechnologies Co., Ltd. ### Status Module #### Completion Date **Date:** 2031-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-02 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-06-02 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Beijing Friendship Hospital #### Lead Sponsor **Class:** INDUSTRY **Name:** Nuwacell Biotechnologies Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** A Trial to Evaluate the Safety and Efficacy of iNK in the Treatment of Subjects for Preventing Recurrence of Acute Myeloid Leukemia After Allogeneic Blood Stem Cell Transplantation. **Detailed Description:** This is an open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability and preliminary efficacy of NCR300 injection. ### Conditions Module **Conditions:** - Acute Myeloid Leukemia **Keywords:** - iNK ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 15 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Cohort1: Low dose NCR300 injection; Cohort2: Mid-low dose NCR300 injection; Cohort3: Mid-high dose NCR300 injection; Cohort4: High dose NCR300 injection. **Intervention Names:** - Biological: NCR300 injection **Label:** NCR300 injection **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - NCR300 injection **Description:** Subjects will receive at least 1 cycle of NCR300 injection. **Name:** NCR300 injection **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Number of participants with Dose-limiting toxicity in 28 days after first infusion **Measure:** Dose-Limiting Toxicity(DLT) **Time Frame:** 4 weeks after initial infusion **Description:** Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0 **Measure:** Adverse Event(AE) or Serious Adverse Event(SAE) **Time Frame:** From the date of initial infusion to a year after initial infusion #### Secondary Outcomes **Description:** Maximum plasma concentration of NCR300 in peripheral blood **Measure:** Maximum plasma concentration(Cmax) **Time Frame:** 2 hours before initial infusion;4 hours ,24 hous, 3 Days after initial infusion.2 hours before second infusion; 24 hous, 3 Days after second infusion. **Description:** Time after doing at which maximun plasma concentration of NCR300 in peripheral blood is reached **Measure:** Time after doing at which maximun plasma concentration is reached(Tmax) **Time Frame:** 2 hours before initial infusion;4 hours ,24 hous, 3 Days after initial infusion.2 hours before second infusion; 24 hous, 3 Days after second infusion. **Description:** The proportion of patients with hematological recurrence within 6 months after initial infusion to all patients **Measure:** Cumulative Incidence of Relapse(CIR) **Time Frame:** 6 Months After Initial Infusion **Description:** Changes in MRD before and after treatment **Measure:** Minimal Residual Disease(MRD) **Time Frame:** From the date of screening to a year after initial infusion ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1.Subjects who understand and voluntarily sign the Informed Consent Form(ICF); 2.18-65years; 3.Clinical diagnosis of AML; 4.Accepted allogeneic blood stem cell transplantation within 60 to 28 days prior before initial infusion; 5.Complete donor chimerism and with high-risk recurrence factors prior to transplantation , or bone marrow examination shows positive MRD； 6.Have already recovered from the adverse reactions of previous treatment； 7.Having appropriate organ functions； 8.Eastern Cooperative Oncology Group(ECOG)\<3; 9.Subjects who are able to comply with contraceptives from the study period to 6 months after the end of this study; Exclusion Criteria: 1. Bone marrow examination shows hematological recurrence; 2. Have malignant tumors within 5 years before screening; 3. Subjects with acute promyelocytic leukemia(APL); 4. Subjects with severe respiratory diseases; 5. Subjects with clear history of neurological or psychiatric disorders in the past; 6. Active central nervous system involvement； 7. HIV(human immunodeficiency virus) antibody positive,treponema pallidum(TP) antibody positive.Have active hepatitis B or hepatitis C; 8. Allergies to NCR300 or its excipients; 9. Subjects with active cardiovascular and cerebrovascular diseases; 10. Received organ transplantation or planned transplantation； 11. Received other treatment drugs after transplantation； 12. Graft-Versus-Host Disease (GVHD)\>II grades; 13. Subjects with active nervous system autoimmune or inflammatory diseases; 14. Expected survival period within 3 months; 15. Have alcohol or drug addiction or with a clear history of mental disorders or with a history of drug abuse or drug use of psychotropic substances; 16. Having mental illness； 17. Having uncontrollable active infections; 18. Subjects whose state is not suitable for entering the study; 19. Other situations determined by investigator that it is not suitable to enter 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:** Xiaowen Gong **Phone:** 15221195602 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Capital Medical University **Name:** Zhao Wang, Doctor **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000006402 - Term: Hematologic Diseases - 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: BC15 - Name: Blood and Lymph Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14850 - Name: Recurrence - Relevance: HIGH - As Found: Recurrence - ID: M10945 - Name: Leukemia - Relevance: HIGH - As Found: Leukemia - ID: M10955 - Name: Leukemia, Myeloid - Relevance: HIGH - As Found: Myeloid Leukemia - ID: M18127 - Name: Leukemia, Myeloid, Acute - Relevance: HIGH - As Found: Acute Myeloid Leukemia - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T3995 - Name: Myeloid Leukemia - Relevance: HIGH - As Found: Myeloid Leukemia - ID: T182 - Name: Acute Myeloid Leukemia - Relevance: HIGH - As Found: Acute Myeloid Leukemia - ID: T188 - Name: Acute Non Lymphoblastic Leukemia - Relevance: HIGH - As Found: Acute Myeloid Leukemia - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007938 - Term: Leukemia - ID: D000007951 - Term: Leukemia, Myeloid - ID: D000015470 - Term: Leukemia, Myeloid, Acute - ID: D000012008 - Term: Recurrence ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441071 **Brief Title:** Patients' Positions on Analgesic Efficacy of ESPB **Official Title:** Effect of Different Patient's Positions on Postoperative Analgesia of Ultrasound-guided Erector Spinae Plane Block #### Organization Study ID Info **ID:** KY20240419-03 #### Organization **Class:** OTHER **Full Name:** Nanjing First Hospital, Nanjing Medical University ### Status Module #### Completion Date **Date:** 2026-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-02 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-04-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-14 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-06-02 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Nanjing First Hospital, Nanjing Medical University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to learn if patients remaining different positions for 30min after receiving ultrasound-guided erector spinae plane block influenced the postoperative analgesia. The main questions it aims to answer are: Does patients maintain prone position or supine position for 30 min after ESPB provided superior analgesic effect than in the supine position? Is ESPB not inferior to PVB considering postoperative opioid consumption ? Researchers will compare the opioid consumption 24h postoperatively among the patients remaining supine, lateral, prone position after ESPB and PVB to see if patients maintaining lateral or prone position provided excellent postoperative analgesia. Participants will: Maintaining supine lateral or prone position for 30 min following ESPB or receiving PVB. Receiving postoperative NRS and QoR assessment **Detailed Description:** After signed the informed consent form, 120 patients scheduled for elective thoracoscopic lobectomy were randomly divided into four groups: supine position group (group S, n = 30), prone position group (group P, n = 30), lateral position group (group L, n = 30) and paravertebral block group (group C, n = 30). After ESPB block, the corresponding position was maintained for 30 minutes. Ultrasound-guided ESPB was performed 30min before general anesthesia. Ultrasound-guided ESPB methods: The ultrasonic high-frequency linear array probe (5-13 MHZ, Sonosite, USA) was placed parallel to the spine on the surface of the transverse process tip of the fifth thoracic vertebra. Under ultrasound, the transverse process and the surface of the erector spinae were clearly exposed. Then a short beved-plane needle was used, and the needle was inserted from the head side. 2ml of normal saline was injected using the water separation technique to confirm the position of the needle tip, and then 30ml 0.375% ropivacaine was injected. After completion of the block, patients in group S were kept in the supine position for 30min, patients in group L were kept in the upper lateral position for 30min, and patients in group P were kept in the prone position for 30min. After 30 minutes of observation, an anesthesiologist who was unaware of the grouping used an ice cube to determine the extent of sensory block. General anesthesia was then performed. General anesthesia was performed as follows: routine ECG monitoring was performed after the patient was admitted to the operating room, and invasive arterial blood pressure was monitored by radial artery puncture and catheterization. General anesthesia was induced with dexamethasone 10mg, midazolam 0.5mg.kg-1, propofol 1.5-2.0 mg.kg-1, sufentanil 0.4 mg.kg-1, cisatracurium 0.2 mg.kg-1, and then a double-luminal bronchial tube was inserted under a video laryngoscope and mechanically ventilated (tidal volume: 6ml.kg-1,PEEP: 3-5 cm H2O). Anesthesia was maintained with propofol (2-4 mg.kg-1.h-1), remifentanil (0.12-0.2 mg.kg-1.min-1) and miuclosamine (0.2mg.kg-1. Intraoperative hemodynamics was maintained within 30% of baseline. Flurbiprofen axetil 50mg was given intravenously for analgesia and tropisetron 4mg was given to prevent nausea and vomiting when there were no contraindications during the operation. Intraoperative infusion was limited to 6ml.kg-1.h-1. Oxycodone 3mg was administered intravenously 30min before the end of the procedure. At the end of the operation, the patient was transferred to PACU with an endotracheal tube. After neuromuscular blocking antagonism, the tracheal tube was extubated. NRS was used to evaluate the pain scores at rest and during movement at 1, 3, 6, 12 and 24h ，48h after operation by a nurse who was unaware of the grouping. Oxycodone 30mg diluted to 150ml was used for patient-controlled intravenous analgesia after operation. The parameters of analgesia pump were set as background dose 1ml.h-1, bolus 5ml, lockout time 8min. If NRS≥4 at rest after surgery, patient-controlled analgesia (PCA) was performed by pressing the PCA pump. When NRS≥4 at rest was still ≥4 after two times of PCA, oxycodone 1mg was given once as rescue analgesia, and the patients were reevaluated until NRS≤3. ### Conditions Module **Conditions:** - Erector Spinae Plane Block **Keywords:** - Paravertebral thoracic block - Clinical application - Perioperative analgesia - Erector spinae plane block ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** After completion of the erector spinae plane block, patients in group S remained in the supine position for 30 minutes. **Intervention Names:** - Procedure: position **Label:** Group S **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** After completion of the erector spinae plane block, patients in group L remained in the lateral position for 30 minutes. **Intervention Names:** - Procedure: position **Label:** Group L **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** After completion of the erector spinae plane block, patients in group P remained in the prone position for 30 minutes. **Intervention Names:** - Procedure: position **Label:** Group P **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** After completion of the paravertebral block, patients in group C remained in the supine position for 30 minutes. **Intervention Names:** - Procedure: position **Label:** Group C **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Group C - Group L - Group P - Group S **Description:** Patients undergoing Video-assisted Thoracoscopic Surgery were selected for the study, and nerve block was performed before surgery, followed by holding different positions for 30 min, after which the effect of the block was measured. **Name:** position **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Cumulative oxycodone dosage 24 hour postoperatively **Measure:** Postoperative Oxycodone dosage **Time Frame:** 24 hour postoperatively #### Secondary Outcomes **Description:** The sensation to cold was assessed with ice. The area include the anterior chest wall (midclavicular line), lateral chest wall (posterior axillary line), and posterior chest wall (paraspinal zone) by a researcher who was blinded to group allocation. **Measure:** Loss to cold sensation of skin **Time Frame:** 30 minute after block **Description:** Postoperative 1, 3, 6, 12, 24, 48 hour NRS (Numeric Rating Scales) score. Numerical Rating Scale (NRS): This scale is composed of 11 numbers from 0 to 10, with higher numbers increasing the severity of pain. **Measure:** NRS(Numeric Rating Scales) score **Time Frame:** Postoperative 1, 3, 6, 12, 24, 48 hour **Description:** This includes dizziness, nausea, vomiting, etc. **Measure:** Adverse reaction **Time Frame:** 24, 48 hour postoperatively **Description:** Postoperative QoR-15(Quality of Recovery) score was used to evaluate the quality of early postoperative recovery on postoperative day 1 and 2. . The QoR-15 score(Quality of Recovery,QoR) included 5 dimensions including emotional state, physical comfort, psychological support, physical independence and pain, with a total of 15 items. Each item scored from 0 to 10, with higher scores being better. **Measure:** QoR-15 score(Quality of Recovery,QoR) **Time Frame:** Day 1 and 2 postoperatively **Description:** Postoperative opioid consumption dosage. **Measure:** Opioid dosage **Time Frame:** 1, 3, 6, 12, 24, 48 hour postoperatively ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Patients undergoing Video-assisted Thoracoscopic Surgery under elective general anaesthesia were selected, regardless of sex, age 18-80 years, BMI: 18-30 kg.m-2, ASA classification I-III. Exclusion Criteria: 1. Allergy to the study drug or allergy to local anaesthetics; 2. History of opioid abuse; 3. Previous nerve block puncture with puncture site infection； 4. Peripheral neuropathy； 5. Coagulation abnormalities, defined as prothrombin time or partial activation time prothrombin time exceeding standard values or international normalised ratio (INR) ≥ 1.4, or platelet count ≤ 70 x 109 L-1. **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:** Xinyi Bu, MD **Phone:** +8618360868010 **Role:** CONTACT #### Locations **Location 1:** **City:** Nanjing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Xinyi Bu, MD - **Phone:** +8618360868010 - **Role:** CONTACT **Country:** China **Facility:** Nanjing First Hospital **State:** Jiangsu **Zip:** 210006 #### Overall Officials **Official 1:** **Affiliation:** Nanjing First Hospital, Nanjing Medical University **Name:** Tao Shan **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### 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: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441058 **Brief Title:** Retrospective Database Study: Influence of Post-endodontic Restoration Placement on Survival of Root Canal-treated Teeth **Official Title:** Influence of the Timing of Post-endodontic Restoration Placement on the Survival of Root Canal-treated Teeth #### Organization Study ID Info **ID:** Timing-post-endodontic #### Organization **Class:** OTHER **Full Name:** University of Göttingen #### Secondary ID Infos **Domain:** Local Ethics Commission **ID:** 20/2/20 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **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:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-28 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Göttingen #### Responsible Party **Investigator Affiliation:** University Medical Center Goettingen **Investigator Full Name:** Philipp Kanzow, PD Dr. med. dent., Dr. rer. medic. **Investigator Title:** Senior Lecturer **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The aim of this study is to assess the influence (i.e. type and timing) of post-endodontic restorations on the survival of root canal-treated teeth and to determine the influence of patient-, tooth-, treatment-, and restoration-specific parameters on longevity. Patients who received a root-canal treatment between 1998 and 1999 with subsequent placement of an indirect restoration (e.g. crown, partial crown) will be retrospectively analyzed. Patient-, tooth-, treatment-, and restoration-specific parameters will be obtained from digital and paper-based dental records. Survival and success of the root-canal treatments will be assessed using Kaplan-Meier statistics. Mean annual failure rates (mAFR) and median survival time will be calculated (Kaplan-Meier statistics). Potential predictive factors will be tested using log-rank tests and multi-variate Cox-regression analysis. ### Conditions Module **Conditions:** - Root Canal Treatment ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 1000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Indirect post-endodontic restorations (e.g. crown, partial crown). **Intervention Names:** - Other: No patient treatment is associated with the study **Label:** Indirect post-endodontic restorations ### Interventions #### Intervention 1 **Arm Group Labels:** - Indirect post-endodontic restorations **Description:** No patient treatment is associated with the study. **Name:** No patient treatment is associated with the study **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Success is defined as the time-interval without a subsequent endodontic re-intervention or extraction of the tooth. **Measure:** Success of endodontic treatment **Time Frame:** 1998-2023 #### Secondary Outcomes **Description:** Survival of the tooth is defined as the time-interval without extraction of the tooth. **Measure:** Survival of the tooth **Time Frame:** 1998-2023 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients who received a root-canal treatment followed by the placement of an indirect post-endodontic restoration (e.g. partial crowns, crowns) within the Department of Preventive Dentistry, Periodontology and Cariology between 1998 and 1999. Exclusion Criteria: * None. **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Patients who received a root-canal treatment followed by the placement of an indirect post-endodontic restoration (e.g. partial crowns, crowns) within the Department of Preventive Dentistry, Periodontology and Cariology between 1998 and 1999. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Philipp Kanzow, PD Dr. Dr. med. dent., M.Sc. **Phone:** 01149-55139 **Phone Ext:** 60890 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Philipp Kanzow, Prof. Dr. med. dent. **Phone:** 01149-55139 **Phone Ext:** 60884 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441045 **Brief Title:** Double Dose of Third-generation EGFR-TKI Plus Intrathecal Pemetrexed Versus Double Dose of Third-generation EGFR-TKI in Patients With LM Progression Following the Treatment of Routine Dose of Third-generation EGFR-TKI **Official Title:** Double Dose of Third-generation EGFR-TKI Plus Intrathecal Pemetrexed Versus Double Dose of Third-generation EGFR-TKI in NSCLC Patients With Leptomeningeal Progression Following the Treatment of Routine Dose of Third-generation EGFR-TKI: a Phase II Randomized, Multicenter Study #### Organization Study ID Info **ID:** SQS2024-175 #### Organization **Class:** OTHER_GOV **Full Name:** Fujian Cancer Hospital ### Status Module #### Completion Date **Date:** 2028-10-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-03 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-04-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-10-01 **Type:** ESTIMATED **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-06-03 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Fujian Cancer Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False ### Description Module **Brief Summary:** We aim to compare the efficacy and safety of double Dose of Third-generation EGFR-TKI Plus Intrathecal Pemetrexed Versus double Dose of Third-generation EGFR-TKI in patients with leptomeningeal progression following the treatment of routine dose of EGFR-TKI, ### Conditions Module **Conditions:** - Leptomeningeal Metastasis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 112 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Double Dose of Third-generation EGFR-TKI - Drug: Intrathecal Pemetrexed **Label:** Double Dose of Third-generation EGFR-TKI Plus Intrathecal Pemetrexed **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Double Dose of Third-generation EGFR-TKI **Label:** Double Dose of Third-generation EGFR-TKI **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Double Dose of Third-generation EGFR-TKI - Double Dose of Third-generation EGFR-TKI Plus Intrathecal Pemetrexed **Description:** Double Dose of Third-generation EGFR-TKI **Name:** Double Dose of Third-generation EGFR-TKI **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Double Dose of Third-generation EGFR-TKI Plus Intrathecal Pemetrexed **Description:** Intrathecal Pemetrexed **Name:** Intrathecal Pemetrexed **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Overall Survival **Time Frame:** From date of randomization until the date of death from any cause assessed up to 12 months after the last patient enrollment #### Secondary Outcomes **Description:** By using QLC 30 questionnaire to investigate the impact of treatment on patients' QoL specifically the physical and neurological function in patients **Measure:** Quality of life by using QLC 30 questionnaire **Time Frame:** every 4 weeks, from date of randomization until the date of first documented progression or date of death from any cause, whichever came first assessed up to 12 months after the last patient enrollment **Measure:** LM-PFS **Time Frame:** From date of randomization until the date of first documented LM progression or date of death from any cause, whichever came first assessed up to 12 months after the last patient enrollment **Measure:** LM-ORR **Time Frame:** From date of randomization until the date of first documented LM progression assessed up to 12 months after the last patient enrollment **Description:** Safety and tolerability **Measure:** Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 **Time Frame:** From date of randomization until the date of first documented LM progression or date of death from any cause, whichever came first assessed up to 12 months after the last patient enrollment **Measure:** exLM-PFS **Time Frame:** From date of randomization until the date of first documented non-LM progression or date of death from any cause, whichever came first assessed up to 12 months after the last patient enrollment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 18 years at the time of signing informed consent, both sexes; * advanced or metastatic NSCLC, TNM stage IV according to the eighth edition of IASLC 2015; * with EGFR sensitive mutation (exon 19 deletion or L858R mutation), LM progression after conventional doses of three generation EGFR targeted agents (after 1 + 3,2 + 3 or direct 3-generation targeted therapy). There is no limit on the number of chemotherapy lines. The enrolled patients required brain parenchyma and extracranial lesion stable * ECOG PS score: 0-3 * Normal main organ function, That is, the following criteria are met: 1. routine blood examination (no blood transfusion within 14 days, no hematopoietic stimulating factor drugs are corrected state): hemoglobin (Hb) 90g / L; Absolute neutrophil count (ANC) 1.5109 / L; Platelet (PLT) 100109 / L; White blood cell count (WBC) 3.0109 / L; 2. Biochemical examination: alanine transaminotransferase (ALT) and alanine transaminotransferase (AST) 2.5 upper limit of normal (ULN); Serum total bilirubin (TBIL) 1.5 ULN; Serum creatinine (Cr) of 1.5 ULN or creatinine clearance of 50 ml/min; If any liver metastasis, Then, the total bilirubin 3 ULN, ALT and AST 5 ULN; C) Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time 12 (PT) 1.5 ULN; d) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) 50%; * If previously treated with chemotherapy, A washout period of at least 21 days between the last chemotherapy dose and enrollment (if the patient does not receive radiotherapy) is required; Patients who treated brain parenchymal metastases with local radiotherapy or surgery before enrollment, Must be completed and fully recovered from the acute toxicity of radiotherapy / surgery. A minimum 14-day washout period is required between the end of radiotherapy and enrollment. A minimum 30-day washout period is required between the end of surgery and enrollment. * Expected survival of not less than 3 months * patients can swallow oral medication (if not oral, can be ground by gastric tube) * Women of childbearing age must have negative pregnancy test (serum or urine) within 14 days before observation period and 3 months after the last administration; for men, they should undergo surgical sterilization or agree to use appropriate contraception during the observation period and 3 months after the last administration of study drug * patients voluntarily participate and sign an informed consent (or legal agent), expected to have good compliance and able to cooperate with the study according to the protocol requirements. Exclusion Criteria: * Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the study program; * Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS) * patient with active bacterial infection, fungal infection (intravenous antibiotics required at initiation of study treatment); * past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring steroid therapy, Or any signs of clinically active interstitial lung disease; * arterial / venous thrombosis events within 6 months prior to enrollment, Such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; * congestive heart failure (NYHA grade\> 2); unstable angina pectoris; a myocardial infarction within 3 months prior to signing an ICF; any 12 supraventricular or ventricular arrhythmia requiring treatment or intervention; Mean QTcF\> 470ms from 3 ECG recordings * other systemic malignancies in the last 5 years, (Except for cured skin basal cell carcinoma and cervical situ carcinoma and ovarian carcinoma); * Use drugs or supplements known to be the main cause of CYP3A4. * Persons known to be allergic to any test drug or its excipients; * pregnant, lactating, reproductive patients unwilling to use effective contraception; ●a clear prior history of neurological or psychiatric disorders, including epilepsy and dementia; * other conditions considered inappropriate by the investigator. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Gen Lin **Phone:** 13313786157 **Role:** CONTACT #### Locations **Location 1:** **City:** Fuzhou **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Gen Lin - **Role:** CONTACT **Country:** China **Facility:** Gen Lin **State:** Fujian #### Overall Officials **Official 1:** **Affiliation:** Fujian Provincial Cancer Hospital, Fuzhou, Fujian, China **Name:** Gen Lin **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009385 - Term: Neoplastic Processes - ID: D000009369 - Term: Neoplasms - 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 ### Condition Browse Module - Browse Leaves - ID: M20559 - Name: Disease Progression - Relevance: LOW - As Found: Unknown - ID: M12307 - Name: Neoplasm Metastasis - Relevance: HIGH - As Found: Metastases - ID: M12330 - Name: Neoplastic Processes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009362 - Term: Neoplasm Metastasis ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - 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: M264 - Name: Pemetrexed - Relevance: HIGH - As Found: New - 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: D000068437 - Term: Pemetrexed ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441032 **Brief Title:** Retrospective Database Study: Survival of Cast Restorations - Restorations Made of Precious Metal vs. Non-precious Metal **Official Title:** Survival of Cast Restorations - Restorations Made of Precious Metal vs. Non-precious Metal #### Organization Study ID Info **ID:** Survival-Cast-Restorations #### Organization **Class:** OTHER **Full Name:** University of Göttingen #### Secondary ID Infos **Domain:** Local Ethics Commission **ID:** 21/11/22 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **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:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-28 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Göttingen #### Responsible Party **Investigator Affiliation:** University Medical Center Goettingen **Investigator Full Name:** Philipp Kanzow, PD Dr. med. dent., Dr. rer. medic. **Investigator Title:** Senior Lecturer **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The aim of this study is to determine and compare the longevity of single-tooth cast restorations made of precious metal vs. non-precious metal (e.g. partial crowns, crowns) and to determine the influence of patient-, tooth-, treatment-, and restoration-specific parameters on longevity. Patients who received single-tooth cast restorations made of precious metal or non-precious metal (e.g. partial crowns, crowns) between 1997 and 2022 will be retrospectively analyzed. Patient-, tooth-, treatment-, and restoration-specific parameters will be obtained from digital and paper-based dental records. Survival and success of the restorations will be assessed using Kaplan-Meier statistics. Mean annual failure rates (mAFR) and median survival time will be calculated (Kaplan-Meier statistics). Potential predictive factors will be tested using log-rank tests and multi-variate Cox-regression analysis. **Detailed Description:** No patient treatment is associated with the study. ### Conditions Module **Conditions:** - Dental Restoration Failure ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 4000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Single-tooth cast restorations made of precious metal. **Intervention Names:** - Other: No patient treatment is associated with the study **Label:** Precious metal #### Arm Group 2 **Description:** Single-tooth cast restorations made of non-precious metal **Intervention Names:** - Other: No patient treatment is associated with the study **Label:** Non-precious metal ### Interventions #### Intervention 1 **Arm Group Labels:** - Non-precious metal - Precious metal **Description:** No patient treatment is associated with the study. **Name:** No patient treatment is associated with the study **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Success is defined as the time-interval without a subsequent re-intervention of the restoration or extraction of the tooth. **Measure:** Success of restoration **Time Frame:** 1997-2023 #### Secondary Outcomes **Description:** Survival is defined as the time-interval without replacement of the restoration or extraction of the tooth. **Measure:** Survival of restoration **Time Frame:** 1997-2023 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients insured in the statutory health insurance. * Patients who received single-tooth cast restorations made of precious metal or non-precious metal (e.g. partial crowns, crowns) within the Department of Preventive Dentistry, Periodontology and Cariology between 1997 and 2022. Exclusion Criteria: * None. **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Patients insured in the statutory health insurance who received single-tooth cast restorations made of precious metal or non-precious metal (e.g. partial crowns, crowns) within the Department of Preventive Dentistry, Periodontology and Cariology between 1997 and 2022. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Philipp Kanzow, PD Dr. Dr. med. dent., M.Sc. **Phone:** 01149-55139 **Phone Ext:** 60890 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Annette Wiegand, Prof. Dr. med. dent. **Phone:** 01149-55139 **Phone Ext:** 60884 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441019 **Brief Title:** Efficacy and Safety of HAIC in Combination With TQB2868 and Ramucirumab for Second-line Treatment of Advanced Hepatocellular Carcinoma **Official Title:** Efficacy and Safety of HAIC in Combination With TQB2868 and Ramucirumab for Second-line Treatment of Advanced Hepatocellular Carcinoma: an Open, Single-arm Exploratory Study #### Organization Study ID Info **ID:** 2403292-19 #### Organization **Class:** OTHER **Full Name:** Fudan University ### Status Module #### Completion Date **Date:** 2026-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-03 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-28 **Study First Submit QC Date:** 2024-06-03 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Fudan University #### Responsible Party **Investigator Affiliation:** Fudan University **Investigator Full Name:** Lu Wang, MD, PhD **Investigator Title:** Chief physician **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** In recent years, with the emergence of various new targeted and immunotherapy drugs, drug therapy for advanced Hepatocellular carcinoma has also seen continuous breakthroughs. The effective rate, progression free survival, and overall survival of advanced Hepatocellular carcinoma have all significantly improved. At present, internationally recognized first-line treatments available include atezolizumab+bevacizumab (T+A), lenvatinib, sorafenib, Durvalumab+tremelimumab, etc. However, the effective rate of first-line treatment has not exceeded 50%, and most patients face difficulties such as drug resistance or treatment failure. Second line treatment for Hepatocellular carcinoma still faces many difficulties and challenges. The aim of this study is to explore the effectiveness and safety of HAIC combined with TQB2868 and Ramucirumab in second-line treatment of advanced HCC patients. ### Conditions Module **Conditions:** - Hepatocellular Carcinoma，Bispecific Antibodies, HAIC, Ramucirumab ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 42 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: HAIC（Oxaliplatin+ Raltitrexed）、TQB2868、Ramucirumab **Label:** HAIC combined with TQB2868 and Ramucirumab **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - HAIC combined with TQB2868 and Ramucirumab **Description:** The patient will receive combined treatment with HAIC, TQB2868, and Ramucirumab. After enrollment, the patient will undergo routine hepatic artery angiography via femoral artery catheterization and placement of a hepatic artery catheter，they will then receive 150ml of 5% sodium bicarbonate + Oxaliplatin (85mg/m2) for 4-6 hours + Raltitrexed (2mg/m2) for 2-4 hours . This will be done every 3-4 weeks for at least 2 cycles. Systemic treatment will be administered every 21 days, with TQB2868 injection given on the first day of each cycle (1-7 days after HAIC). The fixed dose of TQB2868 will be 300mg, and Ramucirumab will be given at a dose of 500mg (initial intravenous infusion for 60 minutes, followed by 30 minutes if tolerated). **Name:** HAIC（Oxaliplatin+ Raltitrexed）、TQB2868、Ramucirumab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including complete response and partial response **Measure:** Objective response rate **Time Frame:** 24 months #### Secondary Outcomes **Description:** Time from enrollment to death **Measure:** Overall Survival (OS) **Time Frame:** Up to approximately 2 years **Description:** Disease Control Rate (DCR) based on RECIST v1.1 assessment **Measure:** Disease Control Rate (DCR) **Time Frame:** 6 months **Description:** Progression-Free Survival (PFS) **Measure:** Progression-Free Survival (PFS) **Time Frame:** Up to approximately 1 years **Description:** Safety and tolerability **Measure:** Incidence of Adverse Events and Treatment-Emergent Adverse Events **Time Frame:** Up to approximately 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or non-pregnant female aged 18-80 years or older; * Signed informed consent form; * The investigator believes that the patient is capable of complying with the study protocol; * Histologically or cytologically confirmed advanced hepatocellular carcinoma (HCC); * Patients who have received first-line treatment for hepatocellular carcinoma and have treatment failure or intolerance; * No prior treatment with HAIC including oxaliplatin; * Prior treatment with tyrosine kinase inhibitors (TKIs) and/or immunotherapy is allowed; * At least one measurable, untreated lesion according to RECIST 1.1 criteria; * Availability of pretreatment tumor tissue sample, if available. If tumor tissue is not available (e.g., exhausted by previous diagnostic testing), the patient remains eligible for participation in the study; * ECOG performance status of 0 or 1 within 14 days prior to enrollment; * Child-Pugh class A or B ≤7 within 14 days prior to enrollment; * Adequate hematologic and organ function; * Any acute clinically significant treatment-related toxicity (from prior therapy) must have resolved to ≤Grade 1 prior to enrollment, except for alopecia; * Negative HIV antibody test result at screening; * Patients with active hepatitis B virus (HBV) infection: HBV DNA \<2000 IU/mL obtained within 28 days prior to starting study treatment and at least 7 days of antiviral treatment (according to local standard of care, e.g., entecavir) prior to enrollment and willingness to continue treatment during the study; Patients with active hepatitis C virus (HCV) infection: HCV RNA \<2000 IU/mL obtained within 28 days prior to starting study treatment and at least 7 days of antiviral treatment prior to enrollment and willingness to continue treatment during the study; * Women of childbearing potential must have a negative pregnancy test (β-HCG) prior to initiation of treatment, and women of childbearing potential and men (who engage in sexual intercourse with women of childbearing potential) must agree to use effective contraception continuously during the treatment period and for 6 months after the last dose of treatment. Exclusion Criteria: * Previous treatment with HAIC containing oxaliplatin; * Expected survival time less than 3 months * History of meningitis; * Current or past autoimmune diseases or immunodeficiency; * Idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on screening computed tomography (CT) scan. Prior radiation pneumonitis in the radiation field (fibrosis) is allowed; * Known active tuberculosis; * Significant cardiovascular disease within 3 months prior to starting study treatment (e.g., New York Heart Association Class II or greater heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmia, or unstable angina; * History of congenital long QT syndrome or corrected QT interval \>500ms (calculated using Fridericia's method) at screening; * History of uncorrectable electrolyte disturbances such as serum potassium, calcium, or magnesium imbalances; * Major surgery within 4 weeks prior to starting study treatment (excluding diagnostic procedures) or anticipation of need for major surgical procedure during the course of the study; * History of malignancy other than HCC within 5 years prior to screening, unless the risk of recurrence or death from the previous malignancy is considered negligible (e.g., 5-year overall survival rate \>90%) and adequately treated in situ cervical cancer, non-melanoma skin cancer, localized prostate cancer, in situ ductal carcinoma, or stage I uterine cancer; * Severe infection within 4 weeks prior to starting study treatment, including but not limited to hospitalization for complications of infection, sepsis, or severe pneumonia; * Treatment with therapeutic antibiotics orally or intravenously within 2 weeks prior to starting study treatment. Patients receiving prophylactic antibiotics (e.g., for prevention of urinary tract infection or exacerbation of chronic obstructive pulmonary disease) are eligible for participation in the study; * Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation; * Receipt of attenuated live vaccines within 4 weeks prior to starting study treatment or anticipated need for such vaccines within 5 months after the last dose of PD-1 antibody therapy; * Untreated or incompletely treated esophageal and/or gastric varices associated with bleeding or patients at high risk of bleeding; * Concurrent HBV and HCV infection. Patients with a history of HCV infection but negative HCV RNA PCR results can be considered not infected with HCV; * Symptomatic, untreated, or gradually progressing central nervous system (CNS) metastases; * Inability to comply with follow-up or concurrent participation in another clinical trial that may interfere with this study; * The investigator deems the patient unsuitable for enrollment. **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:** Lu Wang, MD **Phone:** 181 2129 9555 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Ti Zhang, MD **Role:** CONTACT #### Locations **Location 1:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Lu Wang, MD - **Phone:** 0086-18121299555 - **Role:** CONTACT **Country:** China **Facility:** Fudan University Shanghai Cancer Center **State:** Shanghai **Zip:** 200032 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000000230 - Term: Adenocarcinoma - ID: D000008113 - Term: Liver Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000004066 - Term: Digestive System Diseases - ID: D000008107 - Term: Liver Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M9613 - Name: Carcinoma, Hepatocellular - Relevance: HIGH - As Found: Hepatocellular Carcinoma - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M11113 - Name: Liver Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000006528 - Term: Carcinoma, Hepatocellular ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000020533 - Term: Angiogenesis Inhibitors - ID: D000043924 - Term: Angiogenesis Modulating Agents - ID: D000006133 - Term: Growth Substances - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000006131 - Term: Growth Inhibitors - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000005493 - Term: Folic Acid Antagonists - ID: D000004791 - Term: Enzyme Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Micro - Name: Micronutrients - Abbrev: Hemat - Name: Hematinics - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M1674 - Name: Oxaliplatin - Relevance: HIGH - As Found: Min - ID: M3246 - Name: Ramucirumab - Relevance: HIGH - As Found: Adjuvant therapy - ID: M252094 - Name: Raltitrexed - Relevance: HIGH - As Found: Acrylic - ID: M22318 - Name: Angiogenesis Inhibitors - Relevance: LOW - As Found: Unknown - ID: M9231 - Name: Growth Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown - ID: M17546 - Name: Vitamin B Complex - Relevance: LOW - As Found: Unknown - ID: M8618 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: M8619 - Name: Folic Acid Antagonists - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: T447 - Name: Folinic Acid - Relevance: LOW - As Found: Unknown - ID: T446 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: T448 - Name: Folate - Relevance: LOW - As Found: Unknown - ID: T475 - Name: Vitamin B9 - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077150 - Term: Oxaliplatin - ID: D000096662 - Term: Ramucirumab - ID: C000068874 - Term: Raltitrexed ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06441006 **Acronym:** PRISM-TB **Brief Title:** Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis **Official Title:** Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis (PRISM-TB) #### Organization Study ID Info **ID:** 24-41176 #### Organization **Class:** OTHER **Full Name:** University of California, San Francisco #### Secondary ID Infos **Domain:** USAID **ID:** 7200AA22CA00005 (USAID) **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2029-11-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2029-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-11-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-28 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Johns Hopkins University #### Lead Sponsor **Class:** OTHER **Name:** University of California, San Francisco #### 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:** PRISM-TB is an international, multicenter, open-label, randomized, controlled, pragmatic, stratified medicine, treatment shortening, noninferiority Phase 3 clinical trial for fluoroquinolone-susceptible multidrug-resistant/rifampin-resistant pulmonary tuberculosis (FQ-S MDR/RR-TB). The trial objective is to evaluate whether stratified medicine treatment strategies for FQ-S MDR/RR-TB, defined by a pre-specified risk stratification algorithm, have noninferior efficacy to a one-size-fits-all control regimen (the local standard-of-care \[SOC\] regimen consistent with preferred regimen(s) in international guidelines), as measured by TB-related unfavorable outcomes at Week 73. **Detailed Description:** 690 participants will be randomized to the following arms in a 1:1:1 randomization: Strategy 1 (control strategy): Control regimen for all with FQ-S MDR/RR-TB. The local SOC regimen consistent with preferred regimen(s) in international guidelines. In most cases this will be 26 weeks of bedaquiline, pretomanid, linezolid, and moxifloxacin (6BPaLM). Doses and durations of each component may change based on the latest WHO guidelines and the local SOC. Strategy 2 (investigational strategy): 4BPaLM for all with FQ-S MDR/RR-TB. 17 weeks of bedaquiline, pretomanid, linezolid, and moxifloxacin (4BPaLM). Strategy 3 (investigational strategy): 3BPaLM or 6BPaLM stratified medicine strategy for those with FQ-S MDR/RR-TB. 13 weeks of bedaquiline, pretomanid, linezolid, and moxifloxacin (3BPaLM) for participants classified as having easier-to-treat TB and 26 weeks of bedaquiline, pretomanid, linezolid, and moxifloxacin (6BPaLM) for participants classified as having harder-to-treat TB. ### Conditions Module **Conditions:** - Tuberculosis, Pulmonary - Tuberculosis, Multidrug-Resistant - Tuberculosis, MDR **Keywords:** - Tuberculosis - BPaLM - Bedaquiline - Pretomanid - Linezolid - Moxifloxacin ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Masking Description:** PRISM-TB will not include any placebo. Participants, providers, and pharmacists will be aware of strategy and treatment allocation. Masking of participants to treatment allocation would obscure differences in durations and affect behavior in shortened regimens that would not be reflective of future use and is therefore not included as a feature of this trial. **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 690 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The local SOC regimen consistent with preferred regimen(s) in international guidelines. In most cases this will be 26 weeks of bedaquiline, pretomanid, linezolid, and moxifloxacin (6BPaLM). Doses and durations of each component may change based on the latest WHO guidelines and the local SOC. **Intervention Names:** - Drug: Control Arm FQ-S MDR/RR-TB regimen, designed according to latest WHO guidelines **Label:** Strategy 1: Control regimen for all with FQ-S MDR/RR-TB **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** 17 weeks of bedaquiline, pretomanid, linezolid, and moxifloxacin (4BPaLM). Bedaquiline 400 mg orally once daily for 2 weeks, then 200 mg once daily; pretomanid 200 mg orally once daily; linezolid 600 mg orally once daily; and moxifloxacin 400 mg orally once daily. **Intervention Names:** - Drug: Bedaquiline - Drug: Linezolid - Drug: Pretomanid - Drug: Moxifloxacin **Label:** Strategy 2: 4BPaLM for all with FQ-S MDR/RR-TB **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** 13 weeks of bedaquiline, pretomanid, linezolid, and moxifloxacin (3BPaLM) for participants classified as having easier-to-treat TB and 26 weeks of bedaquiline, pretomanid, linezolid, and moxifloxacin (6BPaLM) for participants classified as having harder-to-treat TB. 3BPaLM: 13 weeks of bedaquiline 400 mg orally once daily for 2 weeks, then 200 mg once daily; pretomanid 200 mg orally once daily, linezolid 600 mg orally once daily, and moxifloxacin 400 mg orally once daily. 6BPaLM: 26 weeks of bedaquiline 400 mg orally once daily for 2 weeks, then 200 mg once daily; pretomanid 200 mg orally once daily, linezolid 600 mg orally once daily, and moxifloxacin 400 mg orally once daily. **Intervention Names:** - Drug: Bedaquiline - Drug: Linezolid - Drug: Pretomanid - Drug: Moxifloxacin **Label:** Strategy 3: 3BPaLM or 6BPaLM stratified medicine strategy for those with FQ-S MDR/RR-TB **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Strategy 2: 4BPaLM for all with FQ-S MDR/RR-TB - Strategy 3: 3BPaLM or 6BPaLM stratified medicine strategy for those with FQ-S MDR/RR-TB **Description:** Frequency: daily Route of administration: oral **Name:** Bedaquiline **Other Names:** - Sirturo **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Strategy 2: 4BPaLM for all with FQ-S MDR/RR-TB - Strategy 3: 3BPaLM or 6BPaLM stratified medicine strategy for those with FQ-S MDR/RR-TB **Description:** Frequency: daily Route of administration: oral **Name:** Linezolid **Other Names:** - Zyvox **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Strategy 2: 4BPaLM for all with FQ-S MDR/RR-TB - Strategy 3: 3BPaLM or 6BPaLM stratified medicine strategy for those with FQ-S MDR/RR-TB **Description:** Frequency: daily Route of administration: oral **Name:** Pretomanid **Other Names:** - Pretamyl **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Strategy 2: 4BPaLM for all with FQ-S MDR/RR-TB - Strategy 3: 3BPaLM or 6BPaLM stratified medicine strategy for those with FQ-S MDR/RR-TB **Description:** Frequency: daily Route of administration: oral **Name:** Moxifloxacin **Other Names:** - Avelox **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - Strategy 1: Control regimen for all with FQ-S MDR/RR-TB **Description:** The local SOC regimen consistent with preferred regimen(s) in international guidelines. In most cases this will be 26 weeks of bedaquiline, pretomanid, linezolid, and moxifloxacin (6BPaLM). Doses and durations of each component may change based on the latest WHO guidelines and the local SOC. **Name:** Control Arm FQ-S MDR/RR-TB regimen, designed according to latest WHO guidelines **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** TB-related unfavorable outcome at 73 weeks post-randomization, defined as death, treatment failure, or recurrence of tuberculosis. **Measure:** Primary Efficacy Outcome: TB-Related Unfavorable Outcome at 73 Weeks **Time Frame:** 73 weeks #### Secondary Outcomes **Description:** TB-related unfavorable outcome at 52 weeks post-randomization, defined as death, treatment failure, or recurrence of tuberculosis. **Measure:** TB-Related Unfavorable Outcome at 52 Weeks **Time Frame:** 52 weeks **Description:** TB-related unfavorable outcome at 104 weeks post-randomization, defined as death, treatment failure, or recurrence of tuberculosis. **Measure:** TB-Related Unfavorable Outcome at 104 Weeks **Time Frame:** 104 weeks **Description:** Mortality **Measure:** Mortality **Time Frame:** 104 weeks **Description:** All Grade 3 or higher AEs up to 30 weeks post-randomization. **Measure:** All Grade 3 or Higher AEs up to 30 Weeks **Time Frame:** 30 weeks **Description:** All Grade 3 or higher AEs up to 52 weeks post-randomization. **Measure:** All Grade 3 or Higher AEs up to 52 Weeks **Time Frame:** 52 weeks **Description:** All AESIs up to 30 weeks post-randomization. **Measure:** All AESIs up to 30 Weeks **Time Frame:** 30 weeks **Description:** All AESIs up to 52 weeks post-randomization. **Measure:** All AESIs up to 52 Weeks **Time Frame:** 52 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: An individual must meet all of the following inclusion criteria at the time of enrollment in order to participate in this study: 1. Confirmed fluoroquinolone-susceptible rifampicin-resistant pulmonary tuberculosis, based on sputum Xpert MTB/RIF and Xpert MTB/XDR, and/or other validated molecular test, and/or phenotypic drug susceptibility testing. a. NOTE: TB diagnosis for purposes of meeting this inclusion criterion can be from a study testing laboratory or from an outside laboratory. 2. Aged ≥ 14 years. 3. A verifiable address or residence location that is readily accessible for visiting, willingness to consent to home visits and phone calls, and willingness to inform the study team of any change of address during the treatment and follow-up period. 4. Ability and willingness of individual to provide written informed consent or written consent from a parent, guardian, or caregiver and assent of the child participant per local ethics committee guidance. 5. Documentation of negative HIV infection status within 30 days prior to study entry or documentation confirming HIV infection at any time before study entry. 6. For individuals with HIV: CD4+ cell count ≥ 100 cells/mm3 based on testing performed within 30 days prior to study entry. 7. For individuals with HIV: Currently being treated with dolutegravir-based antiretroviral therapy (ART), or plan to initiate dolutegravir-based ART at or before study week 8. a. NOTE: Dosing of ART and chemoprophylaxis for opportunistic infections should be reflective of local standard of care based on WHO or national guidelines. The following antiretrovirals are disallowed given significant drug-drug interactions with bedaquiline: efavirenz, etravirine, all protease inhibitors, and cobicistat-boosted elvitegravir. The following antiretroviral is disallowed given risk of myelosuppression with linezolid: zidovudine. 8. For individuals who are pregnant: at screening, evidence by ultrasound of a viable singleton pregnancy with an estimated gestational age at enrollment of ≥ 14 weeks as per screening ultrasound. 9. Chest radiograph obtained within 14 days prior to study entry. Exclusion Criteria: An individual meeting any of the following exclusion criteria at the time of enrollment or initiation of study drugs will be excluded from study participation: 1. Known allergy/sensitivity, intolerance, or any hypersensitivity to components of study TB drugs or their formulation. 2. One or more of the following laboratory parameters: 1. Absolute neutrophil count (ANC) \< 1000/mm3. 2. Hemoglobin level \< 8.0 g/dL. 3. Serum or plasma alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 times the upper limit of normal. 4. Serum or plasma total bilirubin ≥ 3 times the upper limit of normal. 5. Serum or plasma creatinine level ≥ 3 times the upper limit of normal. 6. Evidence of laboratory values consistent with or equivalent to grade 4 toxicity (i.e., potentially life-threatening). 7. NOTE: Persons found not to be eligible due to laboratory abnormalities may be reevaluated within the screening window. 3. QTcF interval ≥ 480 ms within 5 days prior to study entry. 4. One or more risk factors for QT prolongation (apart from age and sex) or other uncorrected risk factors for torsades de pointes: evidence of ventricular pre-excitation (Wolff-Parkinson-White syndrome); electrocardiographic evidence of either complete left bundle branch block or right bundle branch block, or incomplete left bundle branch block or right bundle branch block and QRS complex duration ≥ 120 ms on at least one ECG; current pacemaker implant; congestive heart failure; evidence of second- or third-degree heart block; bradycardia defined by sinus rate less than 50 bpm; personal or family history of long QT syndrome; personal history of arrhythmic cardiac disease, with the exception of sinus arrhythmia; personal history of syncope (i.e., cardiac syncope not including syncope due to vasovagal or epileptic causes). 5. Current grade 2 or higher peripheral neuropathy. a. NOTE: Peripheral neuropathy assessment must be obtained within 7 days prior to study entry. 6. Documentation of Karnofsky Performance Status Score \< 50 obtained within 14 days prior to study entry. 7. Known resistance to bedaquiline, pretomanid, delamanid, linezolid, or fluoroquinolones. 8. Previous use of any second-line anti-TB drugs for more than 14 days during the 12 months prior to the screening visit date. 9. Known or presumed central nervous system TB, osteoarticular TB, or miliary/disseminated TB in the current TB episode. 10. Taking any medication that is contraindicated with study medicines which cannot be stopped (with or without replacement) or requires a washout period longer than 2 weeks (See Section 9.4). 11. Any condition (social or medical or psychological) which, in the opinion of the investigator, would make participation unsafe or interfere with adherence to study requirements. 12. Current enrollment in other therapeutic trials will not be eligible. a. NOTE: Current enrollment of index cases in prevention trials will be allowed on a case-by-case basis, provided that the prevention trial does not include a therapeutic intervention that could affect response to TB treatment. All persons who are not eligible for the PRISM-TB trial will be managed according to local routine practice and may enroll in other studies. Criteria for Exclusion after Entry ('Late Exclusion'): Enrolled individuals who are subsequently determined to meet the following criteria will be classified as 'late exclusions' and study treatment will be discontinued: 1. Bedaquiline, pretomanid, delamanid, linezolid, or fluoroquinolone resistance on phenotypic or molecular drug- susceptibility testing from samples collected up to 4 weeks after randomization. **Minimum Age:** 14 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Gustavo E Velásquez, MD, MPH **Phone:** (628) 206-2400 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Ariana F Austin, MS **Role:** CONTACT #### Locations **Location 1:** **City:** Chisinau **Contacts:** ***Contact 1:*** - **Name:** Elena Tudor - **Role:** CONTACT **Country:** Moldova, Republic of **Facility:** Institute of Phthisiopneumology Chiril Dragniuc **Location 2:** **City:** Ulaanbaatar **Contacts:** ***Contact 1:*** - **Name:** Bazarrahchaa Tsogt - **Role:** CONTACT **Country:** Mongolia **Facility:** National Center for Communicable Diseases **Location 3:** **City:** Kotri **Contacts:** ***Contact 1:*** - **Name:** Uzma Khan - **Role:** CONTACT **Country:** Pakistan **Facility:** Institute of Chest Disease **Location 4:** **City:** Mirpur **Contacts:** ***Contact 1:*** - **Name:** Uzma Khan - **Role:** CONTACT **Country:** Pakistan **Facility:** Civil Hospital Mirpurkhas **Location 5:** **City:** Lima **Contacts:** ***Contact 1:*** - **Name:** Leonid Lecca - **Role:** CONTACT ***Contact 2:*** - **Name:** Dante Vargas - **Role:** CONTACT **Country:** Peru **Facility:** Hospital Nacional Hipólito Unanue **Location 6:** **City:** Lima **Contacts:** ***Contact 1:*** - **Name:** Leonid Lecca - **Role:** CONTACT ***Contact 2:*** - **Name:** Olivia Peña - **Role:** CONTACT **Country:** Peru **Facility:** Hospital Nacional Sergio E. Bernales **Location 7:** **City:** Lima **Contacts:** ***Contact 1:*** - **Name:** Leonid Lecca - **Role:** CONTACT ***Contact 2:*** - **Name:** Rosa Infante - **Role:** CONTACT **Country:** Peru **Facility:** Policlínico SES **Location 8:** **City:** Dasmariñas **Contacts:** ***Contact 1:*** - **Name:** Maria Tarcela S Gler - **Role:** CONTACT **Country:** Philippines **Facility:** TB HIV Research Unit at De La Salle Medical and Health Sciences Institute **Location 9:** **City:** Durban **Country:** South Africa **Facility:** King Dinuzulu Hospital Complex **Location 10:** **City:** Klerksdorp **Contacts:** ***Contact 1:*** - **Name:** Tumelo Moloantoa - **Role:** CONTACT **Country:** South Africa **Facility:** Perinatal HIV Research Unit Matlosana **Location 11:** **City:** Port Elizabeth **Contacts:** ***Contact 1:*** - **Name:** Judith Nomthandazo Dlamini-Miti - **Role:** CONTACT **Country:** South Africa **Facility:** Isango Lethemba TB Research Unit at Jose Pearson TB Hospital **Location 12:** **City:** Hanoi **Contacts:** ***Contact 1:*** - **Name:** Dinh Van Luong - **Role:** CONTACT ***Contact 2:*** - **Name:** Nguyen Binh Hoa - **Role:** CONTACT **Country:** Vietnam **Facility:** Hanoi Lung Hospital #### Overall Officials **Official 1:** **Affiliation:** University of California, San Francisco **Name:** Gustavo E Velásquez, MD, MPH **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009164 - Term: Mycobacterium Infections - ID: D000000193 - Term: Actinomycetales Infections - ID: D000016908 - Term: Gram-Positive Bacterial Infections - ID: D000001424 - Term: Bacterial Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000007239 - Term: Infections - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M17127 - Name: Tuberculosis - Relevance: HIGH - As Found: Tuberculosis - ID: M17147 - Name: Tuberculosis, Pulmonary - Relevance: HIGH - As Found: Tuberculosis, Pulmonary - ID: M20243 - Name: Tuberculosis, Multidrug-Resistant - Relevance: HIGH - As Found: Tuberculosis, Multidrug-Resistant - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M12119 - Name: Mycobacterium Infections - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M19252 - Name: Gram-Positive Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014376 - Term: Tuberculosis - ID: D000014397 - Term: Tuberculosis, Pulmonary - ID: D000018088 - Term: Tuberculosis, Multidrug-Resistant ### Intervention Browse Module - Ancestors - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000059005 - Term: Topoisomerase II Inhibitors - ID: D000059003 - Term: Topoisomerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents - ID: D000011500 - Term: Protein Synthesis Inhibitors - ID: D000000995 - Term: Antitubercular Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: Repr - Name: Reproductive Control Agents ### Intervention Browse Module - Browse Leaves - ID: M400 - Name: Linezolid - Relevance: HIGH - As Found: In vivo - ID: M1722 - Name: Moxifloxacin - Relevance: HIGH - As Found: COPD - ID: M341494 - Name: Bedaquiline - Relevance: HIGH - As Found: Sunscreen - ID: M15118 - Name: Rifampin - Relevance: LOW - As Found: Unknown - ID: M266292 - Name: Norgestimate, ethinyl estradiol drug combination - Relevance: LOW - As Found: Unknown - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4311 - Name: Antitubercular Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077266 - Term: Moxifloxacin - ID: D000069349 - Term: Linezolid - ID: C000493870 - Term: Bedaquiline ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06440993 **Brief Title:** Durvalumab + Intraductal Radiofrequency Ablation (ID-RFA) in Extrahepatic Cholangiocarcinoma **Official Title:** The CLEAN-DUCT / TRITICC-3 Trial - Phase IIa, Prospective, Single Arm, Open Label, Non-randomized, Multi-center Pilot Study of Durvalumab (MEDI4736) + Intraductal Radiofrequency Ablation (ID-RFA) in Extrahepatic Cholangiocarcinoma #### Organization Study ID Info **ID:** CLEAN-DUCT / TRITICC-3 #### Organization **Class:** OTHER **Full Name:** Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest #### Secondary ID Infos **ID:** 2023-509165-21-00 **Type:** CTIS **Domain:** AstraZeneca **ID:** ESR-23-22156 **Type:** OTHER_GRANT **Domain:** IKF Trial ID **ID:** IKF-t070 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2028-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-03 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-06-03 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Universitätsklinikum Düsseldorf, Germany **Class:** UNKNOWN **Name:** Universitätsklinikum Köln, Germany **Class:** INDUSTRY **Name:** AstraZeneca #### Lead Sponsor **Class:** OTHER **Name:** Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest #### 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 present clinical trial is a prospective, investigator-initiated, single-arm, open-label, multicenter phase II trial. Patients with unresectable perihilar and/or ductal CCA with indication for bile duct stenting and palliative systemic therapy as determined by the local multidisciplinary team (MDT), who already resolved cholestasis due to RFA + Stent will be enrolled. We hypothesize that in patients with extrahepatic cholangiocarcinoma, the use of a combination radiofrequency ablation followed by systemic treatment with chemotherapy plus durvalumab might further increase the anti-tumor activity. ### Conditions Module **Conditions:** - Extrahepatic Cholangiocarcinoma - Unresectable Perihilar or Ductal CCA ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 42 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** systemic treatment: - combination treatment for 8 cycles (Q3W): * Gemcitabine, 1,000 mg/m2 IV, on day 1 and 8, * Cisplatin, 25 mg/m2 IV, on day 1 and 8 * Durvalumab, 1,500 mg IV, on day 1 followed by * Durvalumab maintenance, 1,500 mg IV, PLUS • 2 endoscopic intraductal RFA **Intervention Names:** - Drug: Gemcitabine - Drug: Cisplatin - Drug: Durvalumab - Procedure: ID-RFA **Label:** systemic plus ID-RFA **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - systemic plus ID-RFA **Description:** Gemcitabine, 1,000 mg/m2 IV **Name:** Gemcitabine **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - systemic plus ID-RFA **Description:** Cisplatin, 25 mg/m2 IV **Name:** Cisplatin **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - systemic plus ID-RFA **Description:** Durvalumab, 1,500 mg IV **Name:** Durvalumab **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - systemic plus ID-RFA **Description:** endoscopic intraductal RFA **Name:** ID-RFA **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Overall survival rate after 12 months (OS@12months) defined as proportion of patients alive 12 months after enrollment **Measure:** Overall survival rate **Time Frame:** at 12 months #### Secondary Outcomes **Description:** Progression-free survival (PFS) defined as time from enrollment to the date of disease progression or death from any cause **Measure:** Progression-free survival (PFS) **Time Frame:** at study end **Description:** Overall survival (OS) Defined as time from enrollment to the date of death from any cause **Measure:** Overall survival (OS) **Time Frame:** at study end **Description:** Assessment of safety of the treatment as determined by the incidence, nature, causality, frequency, timing and severity of adverse events using NCI CTCAE 5.0 **Measure:** Incidence and nature of adverse events using NCI CTCAE 5.0 **Time Frame:** through study completion, up to 3years **Description:** Time to cholangitis Defined as time from enrollment to the date of confirmed cholangitis **Measure:** Time to cholangitis **Time Frame:** from enrollment to first cholangitis event, up to 3 years **Description:** To assess quality of life (QoL) data from patients using EORTC QLQ-BIL21 **Measure:** To assess quality of life (QoL) data from patients using EORTC QLQ-BIL21 **Time Frame:** through study completion, up to 3years **Description:** To assess quality of life (QoL) data from patients using EORTC QLQ-C30 **Measure:** To assess quality of life (QoL) data from patients using EORTC QLQ-C30 **Time Frame:** through study completion, up to 3years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patient\* has given written informed consent. 2. Patient is ≥ 18 years of age at time of signing the written informed consent. 3. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. 4. Patient has been diagnosed with histologically or cytologically confirmed 1. histologically or cytologically confirmed cholangiocarcinoma as adenocarcinoma of pancreatobiliary type 2. unresectable perihilar and/or ductal cholangiocarcinoma with indication for bile duct stenting and palliative systemic therapy as determined by the local multidisciplinary team (MDT) and already resolved cholestasis due to RFA + stent 5. Patient tolerated RFA prior to inclusion and is eligible for repeat RFA during the study (does not have any contraindications) as determined by investigator. 6. Patient is eligible for palliative systemic therapy based on clinical and laboratory parameters (except hyperbilirubinemia) as determined by the local MDT 7. Patient has a ECOG ≤ 1. 8. Patient has life expectancy of ≥ 12 weeks 9. Patient has body weight \> 30 kg 10. Adequate blood count, liver-enzymes, and renal function: 1. ANC \> 1,500 cells/μL without the use of hematopoietic growth factors 2. Platelet count ≥ 100 x 109/L (\>100,000 per mm3) 3. Hemoglobin ≥ 9 g/dL 4. Serum total bilirubin ≤ 3x upper normal limit (ULN) (biliary drainage is allowed for biliary obstruction; elevated bilirubin should be caused by obstruction not impaired liver function as assessed by albumin and INR values) 5. Albumin levels ≥ 2.8 g/dL 6. Patients not receiving therapeutic anticoagulation must have an INR\< 2.0 ULN and PTT \< 1.5 ULN within 7 days prior to randomization. The use of full dose anticoagulants is allowed as long as the INR or PTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose for anticoagulants for at least three weeks at the time of inclusion 7. AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional ULN unless liver metastases are present, in which case it must be ≤ 5x ULN 8. Serum Creatinine ≤ 1.5 x ULN and a calculated creatinine clearance rate ≥ 60 mL /min 11. Female patients defined as women of childbearing potential (WOCBP) or male patients with WOCBP partners must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 6 months after the last dose of chemotherapy or for at least 3 months after last dose of durvalumab, whatever happens last. Male patients must refrain from donating sperm during this same period. Male patients with a pregnant partner must agree to remain abstinent or to use a condom for the duration of the pregnancy. Exclusion Criteria: 1. Patient received previous or simultaneous endobiliary treatment other than RFA (e.g. PDT or brachytherapy) 2. Patient received previous systemic therapy with a PD-1, PD-L1 inhibitor (including durvalumab) or CTLA4 inhibitor or classical chemotherapy agents like platinum, fluoropyrimidine or gemcitabine-based regimens. 3. Patient receives any concurrent chemotherapy, investigational product or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer related conditions (e.g., hormone replace therapy) is acceptable. 4. Patient has known hypersensitivity to any component of the durvalumab formulation as well as a known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion protein and/or any known contraindication (including hypersensitivity) to gemcitabine or cisplatin. 5. Patient has history of primary immunodeficiency 6. Patient has stage B cirrhosis according to Child-Pugh criteria (or worse) or cirrhosis (of any grade) with a history of hepatic encephalopathy or clinically significant ascites resulting from cirrhosis. Clinically significant ascites is defined as ascites resulting from cirrhosis requiring diuretics or paracentesis. 7. Patient has any unresolved NCI CTCAE grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and laboratory values defined in the inclusion criteria 1. Patients with grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the Lead Investigator 2. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Lead Investigator. 8. Patient had a prior allogeneic bone marrow transplantation or prior solid organ transplantation. 9. Patient has active or history of autoimmune or inflammatory disorders (including, but not limited to, inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis\]) . The following are exceptions: 1. Patients with vitiligo or alopecia 2. Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement 3. Patients with any chronic skin condition that does not require systemic therapy 4. Patients with celiac disease controlled by diet alone 5. Patients without active disease in the last 5 years may be included but only after consultation with the Lead Investigator 10. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Christoph Roderburg, Prof. Dr. **Phone:** +49 211 8108030 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Johanna Riedel, Dr. **Phone:** +49 69 5899 787 **Phone Ext:** 57 **Role:** CONTACT #### Locations **Location 1:** **City:** Düsseldorf **Contacts:** ***Contact 1:*** - **Name:** Christoph Roderburg, Prof. Dr. - **Role:** CONTACT **Country:** Germany **Facility:** Universitätsklinikum Düsseldorf **Location 2:** **City:** Köln **Contacts:** ***Contact 1:*** - **Name:** Dirk Waldschmidt, Dr. - **Role:** CONTACT **Country:** Germany **Facility:** Universitätsklinikum Köln #### Overall Officials **Official 1:** **Affiliation:** Frankfurter Institut fuer Klinische Krebsforschung IKF GmbH **Name:** Salah-Eddin SE Al-Batran, Prof. Dr. **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000000230 - Term: Adenocarcinoma - ID: D000002277 - Term: Carcinoma - 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 - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M20426 - Name: Cholangiocarcinoma - Relevance: HIGH - As Found: Extrahepatic Cholangiocarcinoma - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M5534 - Name: Carcinoma - 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: T755 - Name: Bile Duct Cancer - Relevance: HIGH - As Found: Cholangiocarcinoma ### Condition Browse Module - Meshes - ID: D000018281 - Term: Cholangiocarcinoma ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000074322 - Term: Antineoplastic Agents, Immunological ### 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: M272500 - Name: Durvalumab - Relevance: HIGH - As Found: Docetaxel - ID: M2985 - Name: Gemcitabine - Relevance: HIGH - As Found: Activity - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000093542 - Term: Gemcitabine - ID: C000613593 - Term: Durvalumab ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06440980 **Brief Title:** A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight **Official Title:** A Multiple-Dose Study to Investigate the Bioequivalence of Orforglipron (LY3502970) Capsules and Orforglipron Tablets in Participants With Obesity or Overweight Who Are Otherwise Healthy. #### Organization Study ID Info **ID:** 18617 #### Organization **Class:** INDUSTRY **Full Name:** Eli Lilly and Company #### Secondary ID Infos **Domain:** Eli Lilly and Company **ID:** J2A-MC-GZPI **Type:** OTHER ### Status Module #### Completion Date **Date:** 2025-05-21 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05-21 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-24 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Eli Lilly and Company #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The main purpose of this study is to see how much of orforglipron (study drug) gets into the bloodstream and how long it takes the body to get rid of it when given as capsules compared to tablets in healthy overweight and obese participants. The safety and tolerability (side effects) of orforglipron when given as capsules and tablets will also be evaluated. The study will be conducted in two parts, with part A and B lasting up to approximately 25 and 22 weeks each, including the screening period. ### Conditions Module **Conditions:** - Healthy - Obese - Overweight - Obesity **Keywords:** - Pharmacokinetics ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 508 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive different sequence of orforglipron doses administered either tablet or capsule at different dose levels. **Intervention Names:** - Drug: Orforglipron **Label:** Part A: Relative bioavailability study: Cohort 1 and 2: Orforglipron **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive different sequence of orforglipron doses administered either tablet (different dose levels) or capsule (test dose levels 1 to 6). **Intervention Names:** - Drug: Orforglipron **Label:** Part B: BE (bioequivalence) study: Cohort 1 and 2: Orforglipron **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Part A: Relative bioavailability study: Cohort 1 and 2: Orforglipron - Part B: BE (bioequivalence) study: Cohort 1 and 2: Orforglipron **Description:** Administered orally **Name:** Orforglipron **Other Names:** - LY3502970 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** τ is 24 hours for once daily (QD) dosing **Measure:** Part B: Pharmacokinetics (PK): Steady-state area under the concentration versus time curve from time 0 to τ hour time point AUC(0-τ) of Orforglipron capsule at test dose levels 2,3,4 and 6 along with the corresponding tablet dose strengths **Time Frame:** Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2) **Measure:** Part B: PK: Steady-state Maximum Observed Concentration (Cmax) of Orforglipron capsule at test dose levels 2,3,4 and 6 along with the corresponding tablet dose strengths **Time Frame:** Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2) #### Secondary Outcomes **Description:** τ is 24 hours for QD dosing **Measure:** Part B: PK: Steady-state AUC(0-τ) of Orforglipron capsule at test dose levels 1 and 5 along with the corresponding tablet dose strengths **Time Frame:** Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2) **Measure:** Part B: PK: Steady-state Cmax of Orforglipron capsule at test dose levels 1 and 5 along with the corresponding tablet dose strengths **Time Frame:** Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participants who are overtly healthy as determined by medical history and physical examination. * Have a stable body weight for one month prior to screening (less than or equal to 5 percent body weight gain or loss) and Body Mass Index (BMI) in range of 27 to 40 kilogram per meter square (kg/m²). * Participants must be reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures. * Have venous access sufficient to allow for blood sampling. Exclusion Criteria: * Have hemoglobin A1c (HbA1c) level of 6.5 percent (%) or greater. * Have significant history of or currently have major depressive disorder or psychiatric disorder within the last 2 years. * Obesity induced by other endocrine disorders, such as Cushing's syndrome or Prader-Willi syndrome. * Have known clinically significant gastric emptying abnormality. * Have undergone bariatric surgery (for example: Lap-Band, Gastric Bypass) * Have a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or any form of thyroid cancer. * Have an abnormal 12-lead electrocardiogram (ECG) at screening. * Have history of pancreatitis. * Judged by the study investigator to be at serious suicidal risk and have answered "Yes" to either question 4 or 5 on the Columbia-Suicide Severity Rating Scale \[C-SSRS\]). * Have difficulty swallowing capsules or tablets. **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:** There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or **Phone:** 1-317-615-4559 **Role:** CONTACT #### Locations **Location 1:** **City:** Daytona Beach **Contacts:** ***Contact 1:*** - **Phone:** 386-366-6490 - **Role:** CONTACT ***Contact 2:*** - **Name:** Kathleen Doisy - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Fortrea CRU, Inc. **State:** Florida **Zip:** 32117 #### Overall Officials **Official 1:** **Affiliation:** Eli Lilly and Company **Name:** Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M26186 - Name: Overweight - Relevance: HIGH - As Found: Overweight - ID: M12701 - Name: Obesity - Relevance: HIGH - As Found: Obesity - ID: M25307 - Name: Overnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009765 - Term: Obesity - ID: D000050177 - Term: Overweight ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06440967 **Brief Title:** A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy **Official Title:** A Randomized, Placebo-controlled, Double-blind, Phase 3 Clinical Study to Investigate the Efficacy and Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms (Hot Flashes) in Women With Stage 0 to 3 Hormone Receptor-positive Breast Cancer Who Are Receiving Adjuvant Endocrine Therapy #### Organization Study ID Info **ID:** 2693-CL-1303 #### Organization **Class:** INDUSTRY **Full Name:** Astellas Pharma Inc ### Status Module #### Completion Date **Date:** 2027-08-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-10-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-29 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Astellas Pharma Global Development, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** One of the standard treatments for women with breast cancer is hormone therapy, but this treatment can cause hot flashes. Hormone replacement therapy, or HRT, is most often prescribed for hot flashes for women in menopause but cannot be given to women on hormone therapy for breast cancer. Fezolinetant, an alternative to HRT, treats hot flashes for women in menopause. As hot flashes happen in the same way for women on hormone therapy for breast cancer, fezolinetant could help these women. In this study, women on hormone therapy for breast cancer who have moderate to severe hot flashes will take part. They will either take fezolinetant or a placebo to treat their hot flashes. The placebo looks like fezolinetant but doesn't have any medicine in it. The main aim of this study is to confirm if women who take fezolinetant have fewer hot flashes that are less severe compared to women who take the placebo. Women 18 years or older seeking treatment for hot flashes. They can take part in the study if they have an average of 7 or more moderate to severe hot flashes each day. They are having hormone therapy for breast cancer from stage 0 (cancer cells that have not spread to nearby tissue) up to stage 3+ (the cancer has spread from the breast to the lymph nodes near the breast or the chest wall). The women will be assigned 1 of 2 study treatments (fezolinetant or placebo) by chance alone. Treatment will be double-blinded. That means that the women in the study and the study doctors will not know who takes which of the study treatments (fezolinetant or placebo). Women who take part in the study will take 1 tablet every day for 52 weeks (1 year). Each woman will be given an electronic handheld device with an app to track their hot flashes. Some women may be able to use the app on their own smartphone. In the last 10 days before their next clinic visit, the women will record information about their hot flashes. They will also use another device to answer questions about how hot flashes affect their daily life. During the study, the women will visit their study clinic about every 4 weeks for a health check. This will include some blood tests. Some visits will also include a bone scan (called a DXA scan) and a liver ultrasound. Women who have a womb (uterus) will also have a test called a transvaginal ultrasound. A probe is gently placed inside the vagina. Sound waves will create a picture of the organs in the pelvis. This will allow the study doctor to look more closely at the uterus and surrounding organs. The last clinic visit will be 3 weeks after the women take their last tablet of study treatment (fezolinetant or placebo). ### Conditions Module **Conditions:** - Hot Flashes **Keywords:** - ESN364; - vasomotor symptoms; - fezolinetant; - VEOZAH™ ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 540 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants taking tamoxifen or an aromatase inhibitor will receive fezolinetant once daily for 52 weeks. **Intervention Names:** - Drug: Fezolinetant - Drug: Tamoxifen - Drug: Aromatase inhibitor **Label:** Fezolinetant **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants taking tamoxifen or an aromatase inhibitor will receive matching placebo once daily for 52 weeks. **Intervention Names:** - Drug: Placebo - Drug: Tamoxifen - Drug: Aromatase inhibitor **Label:** Plabebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Fezolinetant **Description:** oral **Name:** Fezolinetant **Other Names:** - ESN364; - VEOZAH™ **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Plabebo **Description:** oral **Name:** Placebo **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Fezolinetant - Plabebo **Description:** oral **Name:** Tamoxifen **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Fezolinetant - Plabebo **Description:** oral **Name:** Aromatase inhibitor **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Frequency of moderate and severe vasomotor symptoms (VMS) events will be calculated as the sum of moderate and severe VMS events per day. **Measure:** Mean change from Baseline to Week 4 in the frequency of moderate to severe VMS **Time Frame:** Baseline to Week 4 **Description:** Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day. **Measure:** Mean change from Baseline to Week 12 in the frequency of moderate to severe VMS **Time Frame:** Baseline to Week 12 **Description:** The severity of VMS will be calculated using a weighted average of VMS events. **Measure:** Mean change from Baseline to Week 4 in the severity of moderate to severe VMS **Time Frame:** Baseline to Week 4 **Description:** The severity of VMS will be calculated using a weighted average of VMS events. **Measure:** Mean change from Baseline to Week 12 in the severity of moderate to severe VMS **Time Frame:** Baseline to Week 12 #### Secondary Outcomes **Description:** The Menopause-specific Quality of Life Questionnaire (MENQOL) is a 29-item patient-reported outcome (PRO) measure that assesses the impact of 4 domains of menopausal symptoms, as experienced over the last week: vasomotor, psychosocial, physical and sexual. Each item score ranges from 1 to 8, and each domain is scored separately; each domain mean ranges from 1 to 8. The overall questionnaire score is the mean of the domain means. Higher scores represent more bothersome menopausal symptoms. A reduction (improvement) of 1 is the minimum clinically important difference in MENQoL. **Measure:** Mean change from Baseline to Week 12 in the MENQOL VMS 1 week recall domain score **Time Frame:** Baseline to Week 12 **Description:** The Patient-reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b (PROMIS SD SF 8b) assesses self-reported sleep disturbance over the past 7 days and includes perceptions of: restless sleep; satisfaction with sleep; refreshing sleep; difficulties sleeping, getting to sleep or staying asleep; amount of sleep; and sleep quality. Responses to each of the 8 items range from 1 to 5 and the range of possible summed raw scores is 8 to 40. Higher scores on the PROMIS SD SF 8b indicate more of the concept measured (disturbed sleep). **Measure:** Mean Change from Baseline to Week 12 in the PROMIS SD SF 8b Total Score **Time Frame:** Baseline to Week 12 **Description:** Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day. **Measure:** Mean change from Baseline to Week 24 in the frequency of moderate to severe VMS **Time Frame:** Baseline to Week 24 **Description:** The severity of VMS will be calculated using a weighted average of VMS events. **Measure:** Mean Change from Baseline to Week 24 in the severity of moderate to severe VMS **Time Frame:** Baseline to Week 24 **Description:** A TEAE is defined as Adverse Event (AE) observed after starting administration of the investigational study intervention and up to 21 days after the last dose of investigational study intervention. **Measure:** Number of participants with Treatment Emergent Adverse Events (TEAEs) **Time Frame:** Up to Week 55 **Description:** AEs of special interest in this study will include: Progression of breast cancer including metastasis; Adverse events of uterine bleeding; Adverse events of liver test elevations; Any liver AE leading to discontinuation. **Measure:** Number of participants with Adverse Events of Special Interest (AESIs) **Time Frame:** Up to Week 55 **Description:** Number of participants with potentially clinically significant laboratory values. **Measure:** Number of participants with laboratory value abnormalities and/or adverse events (AEs) **Time Frame:** Up to Week 55 **Description:** Number of participants with potentially clinically significant vital sign values. **Measure:** Number of participants with vital sign abnormalities and/or adverse events (AEs) **Time Frame:** Up to Week 55 **Description:** Number of participants with potentially clinically significant ECG values. **Measure:** Number of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs) **Time Frame:** Up to Week 52 **Description:** Number of participants with potentially clinically significant mammogram or breast ultrasound values. **Measure:** Number of participants with mammogram or breast ultrasound abnormalities and/or adverse events (AEs) **Time Frame:** Day 1 **Description:** Number of participants with potentially clinically significant TVU values. **Measure:** Number of participants with transvaginal ultrasound (TVU) abnormalities and/or adverse events (AEs) **Time Frame:** Up to Week 52 **Description:** Number of participants with potentially clinically significant DXA values. **Measure:** Number of participants with dual-energy X-ray absorptiometry (DXA) abnormalities and/or adverse events (AEs) **Time Frame:** Up to Week 52 **Description:** Number of participants with potentially clinically significant liver ultrasound values. **Measure:** Number of participants with liver ultrasound abnormalities and/or adverse events (AEs) **Time Frame:** Up to Week 52 **Description:** Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day. **Measure:** Mean change from Baseline in the frequency of moderate to severe VMS to the average frequency of moderate to severe VMS over Weeks 1 to 3 **Time Frame:** Baseline and Weeks 1 to 3 **Description:** Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day. **Measure:** Mean Change from Baseline in the frequency of moderate to severe VMS to the average frequency of moderate to severe VMS over Weeks 5 to 11 **Time Frame:** Baseline and Weeks 5 to 11 **Description:** The severity of VMS will be calculated using a weighted average of VMS events. **Measure:** Mean change from Baseline in the severity of moderate to severe VMS to the average severity of moderate to severe VMS over weeks 1 to 3 **Time Frame:** Baseline and Weeks 1 to 3 **Description:** The severity of VMS will be calculated using a weighted average of VMS events. **Measure:** Mean Change from Baseline in the severity of moderate to severe VMS to the average severity of moderate to severe VMS over weeks 5 to 11 **Time Frame:** Baseline and Weeks 5 to 11 **Description:** Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day. Percent reduction of \>/= 50% will be reported. **Measure:** Percent reduction >/= 50% in the frequency of moderate and severe VMS from baseline **Time Frame:** Baseline to Weeks 1, 4, 8 and 12 **Description:** Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day. Percent reduction of \>/= 75% will be reported. **Measure:** Percent reduction >/= 75% in the frequency of moderate and severe VMS from baseline **Time Frame:** Baseline to Weeks 1, 4, 8 and 12 **Description:** Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day. Percent reduction of 100% will be reported. **Measure:** Percent reduction at 100% in the frequency of moderate and severe VMS from baseline **Time Frame:** Baseline to Weeks 1, 4, 8 and 12 **Description:** CL/F will be recorded from the PK plasma samples collected. **Measure:** Pharmacokinetics (PK) of Fezolinetant in Plasma: Apparent Clearance (CL/F) **Time Frame:** Up to Week 24 **Description:** Vc/F will be recorded from the PK plasma samples collected. **Measure:** PK of Fezolinetant in Plasma: apparent volume of distribution (Vc/F) **Time Frame:** Up to Week 24 **Description:** Cavg will be recorded from the PK plasma samples collected. **Measure:** PK of Fezolinetant in Plasma: average concentration (Cavg) for participants taking tamoxifen **Time Frame:** Up to Week 24 **Description:** Cavg will be recorded from the PK plasma samples collected. **Measure:** PK of Fezolinetant in Plasma: Cavg for participants taking aromatase inhibitors **Time Frame:** Up to Week 24 **Description:** Ctrough will be recorded from the PK plasma samples collected. **Measure:** PK of Fezolinetant in Plasma: trough concentration (Ctrough) for participants taking tamoxifen **Time Frame:** Up to Week 24 **Description:** Ctrough will be recorded from the PK plasma samples collected. **Measure:** PK of Fezolinetant in Plasma: Ctrough for participants taking tamoxifen **Time Frame:** Up to Week 24 **Description:** CL/F will be recorded from the PK plasma samples collected. **Measure:** PK of tamoxifen in Plasma: CL/F **Time Frame:** Up to Week 24 **Description:** Vc/F will be recorded from the PK plasma samples collected. **Measure:** PK of tamoxifen in Plasma: Vc/F **Time Frame:** Up to Week 24 **Description:** Cavg will be recorded from the PK plasma samples collected. **Measure:** PK of tamoxifen in Plasma: Cavg **Time Frame:** Up to Week 24 **Description:** Ctrough will be recorded from the PK plasma samples collected. **Measure:** PK of tamoxifen in Plasma: Ctrough **Time Frame:** Up to Week 24 **Description:** CL/F will be recorded from the PK plasma samples collected. **Measure:** PK of tamoxifen Metabolite 4-OH tamoxifen in Plasma: CL/F **Time Frame:** Up to Week 24 **Description:** Vc/F will be recorded from the PK plasma samples collected. **Measure:** PK of tamoxifen Metabolite 4-OH tamoxifen in Plasma: Vc/F **Time Frame:** Up to Week 24 **Description:** Cavg will be recorded from the PK plasma samples collected. **Measure:** PK of tamoxifen Metabolite 4-OH tamoxifen in Plasma: Cavg **Time Frame:** Up to Week 24 **Description:** Ctrough will be recorded from the PK plasma samples collected. **Measure:** PK of tamoxifen Metabolite 4-OH tamoxifen in Plasma: Ctrough **Time Frame:** Up to Week 24 **Description:** CL/F will be recorded from the PK plasma samples collected. **Measure:** PK of tamoxifen Metabolite N-desmethyltamoxifen in Plasma: CL/F **Time Frame:** Up to Week 24 **Description:** Vc/F will be recorded from the PK plasma samples collected. **Measure:** PK of tamoxifen Metabolite N-desmethyltamoxifen in Plasma: Vc/F **Time Frame:** Up to Week 24 **Description:** Cavg will be recorded from the PK plasma samples collected. **Measure:** PK of tamoxifen Metabolite N-desmethyltamoxifen in Plasma: Cavg **Time Frame:** Up to Week 24 **Description:** Ctrough will be recorded from the PK plasma samples collected. **Measure:** PK of tamoxifen Metabolite N-desmethyltamoxifen in Plasma: Ctrough **Time Frame:** Up to Week 24 **Description:** CL/F will be recorded from the PK plasma samples collected. **Measure:** PK of tamoxifen Metabolite endoxifen in Plasma: CL/F **Time Frame:** Up to Week 24 **Description:** Vc/F will be recorded from the PK plasma samples collected. **Measure:** PK of tamoxifen Metabolite endoxifen in Plasma: Vc/F **Time Frame:** Up to Week 24 **Description:** Cavg will be recorded from the PK plasma samples collected. **Measure:** PK of tamoxifen Metabolite endoxifen in Plasma: Cavg **Time Frame:** Up to Week 24 **Description:** Ctrough will be recorded from the PK plasma samples collected. **Measure:** PK of tamoxifen Metabolite endoxifen in Plasma: Ctrough **Time Frame:** Up to Week 24 **Description:** CL/F will be recorded from the PK plasma samples collected. **Measure:** PK of aromatase inhibitors in Plasma: CL/F **Time Frame:** Up to Week 24 **Description:** Vc/F will be recorded from the PK plasma samples collected. **Measure:** PK of aromatase inhibitors in Plasma: Vc/F **Time Frame:** Up to Week 24 **Description:** Cavg will be recorded from the PK plasma samples collected. **Measure:** PK of aromatase inhibitors in Plasma: Cavg **Time Frame:** Up to Week 24 **Description:** Ctrough will be recorded from the PK plasma samples collected. **Measure:** PK of aromatase inhibitors in Plasma: Ctrough **Time Frame:** Up to Week 24 **Description:** The MENQOL is a 29-item PRO measure that assesses the impact of 4 domains of menopausal symptoms, as experienced over the last week: vasomotor, psychosocial, physical and sexual. The total score is the mean of the domain means. Higher scores represent more bothersome menopausal symptoms. A reduction (improvement) of 1 is the minimum clinically important difference for the MENQoL. **Measure:** Mean change from Baseline in the MENQOL Total Score **Time Frame:** Baseline to Weeks 4, 8, 12 and 24 **Description:** The MENQOL is a 29-item PRO measure that assesses the impact of 4 domains of menopausal symptoms, as experienced over the last week: vasomotor, psychosocial, physical and sexual. Each item score ranges from 1 to 8, and each domain is scored separately; each domain mean ranges from 1 to 8. Higher scores represent more bothersome menopausal symptoms. **Measure:** Mean change from Baseline in the MENQOL VMS 1-week recall domain score **Time Frame:** Baseline to Weeks 4, 8 and 24 **Description:** The MENQOL is a 29-item PRO measure that assesses the impact of 4 domains of menopausal symptoms, as experienced over the last week: vasomotor, psychosocial, physical and sexual. Each item score ranges from 1 to 8, and each domain is scored separately; each domain mean ranges from 1 to 8. Higher scores represent more bothersome menopausal symptoms. **Measure:** Mean change from Baseline in the MENQOL psychosocial 1-week recall domain score **Time Frame:** Baseline to Weeks 4, 8, 12 and 24 **Description:** The MENQOL is a 29-item PRO measure that assesses the impact of 4 domains of menopausal symptoms, as experienced over the last week: vasomotor, psychosocial, physical and sexual. Each item score ranges from 1 to 8, and each domain is scored separately; each domain mean ranges from 1 to 8. Higher scores represent more bothersome menopausal symptoms. **Measure:** Mean change from Baseline in the MENQOL physical 1-week recall domain score **Time Frame:** Baseline to Weeks 4, 8, 12 and 24 **Description:** The MENQOL is a 29-item PRO measure that assesses the impact of 4 domains of menopausal symptoms, as experienced over the last week: vasomotor, psychosocial, physical and sexual. Each item score ranges from 1 to 8, and each domain is scored separately; each domain mean ranges from 1 to 8. Higher scores represent more bothersome menopausal symptoms. **Measure:** Mean change from Baseline in the MENQOL sexual 1-week recall domain score **Time Frame:** Baseline to Weeks 4, 8, 12 and 24 **Description:** The PROMIS SD SF 8b assesses self reported sleep disturbance over the past 7 days and includes perceptions of: restless sleep; satisfaction with sleep; refreshing sleep; difficulties sleeping, getting to sleep or staying asleep; amount of sleep; and sleep quality. Responses to each of the 8 items range from 1 to 5 and the range of possible summed raw scores is 8 to 40. Higher scores on the PROMIS SD SF 8b indicate more of the concept measured (disturbed sleep). **Measure:** Mean change from Baseline in the PROMIS SD SF 8b Total Score **Time Frame:** Baseline to Weeks 4, 8 and 24 **Description:** The PGI-C VMS evaluates patient perceived change in hot flashes/night sweats from the initiation of treatment. Ratings range from (1) much better to (7) much worse. **Measure:** Scores on the Patient Global Impression of Change (PGI-C) VMS **Time Frame:** Up to Week 24 **Description:** The PGI-S VMS evaluates patient perceived severity of hot flashes/night sweats. Ratings range from (1) no problems to (4) severe problems. **Measure:** Change from Baseline in the Patient Global Impression of Severity (PGI-S) VMS Score **Time Frame:** Baseline to Weeks 4, 8, 12 and 24 **Description:** PGI-C SD evaluates patient perceived change in sleep disturbance from the initiation of treatment. Ratings range from (1) much better to (7) much worse. **Measure:** Scores on the PGI-C sleep disturbance (SD) **Time Frame:** Up to Week 24 **Description:** The PGI-S SD evaluates patient perceived severity of sleep disturbance. Ratings range from (1) no problems to (4) severe problems. **Measure:** Change from Baseline in the PGI-S SD Score **Time Frame:** Baseline to Weeks 4, 8, 12 and 24 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participant has a personal history of stage 0-3 hormone receptor positive (HR+), either human epidermal growth factor receptor (HER)-2+ or HER-2- breast cancer; appropriate documentation includes a written or electronic report. * Participant must be receiving stable maintenance adjuvant endocrine therapy (tamoxifen 20 mg daily or aromatase inhibitors, such as anastrozole, letrozole and exemestane) with or without gonadotropin-releasing hormone (GnRH) agonists/antagonists for a minimum of 4 months and be planning to continue on adjuvant endocrine therapy for the duration of the trial without change to therapy, brand or dose. Add-on therapies for breast cancer adjuvant treatment (e.g., cyclin dependent kinase-4 (CDK4) inhibitors) are allowed. * Participant has a minimum average of 7 moderate to severe hot flashes (HFs) (vasomotor symptoms (VMS)) per day as recorded in the electronic daily diary (data must be available for at least 7 of the last 10 days prior to randomization). * Has an European Cooperative Oncology Group (ECOG) score 0 or 1. * Has at least 12-month life expectation. * Participant is born female. * Female participant: Is not pregnant and at least 1 of the following conditions apply: * Not a woman of childbearing potential (WOCBP) * WOCBP who has a negative urine or serum pregnancy test at screening and day 1 and agrees to follow the contraceptive guidance from the time of informed consent through at least 30 days after final study intervention administration. * Female participant: Must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 30 days after final study intervention administration. * Female participant: Must not donate ova starting at first administration of study intervention and throughout the investigational period and for 30 days after final study intervention administration. * Participant agrees not to participate in another interventional study while participating in the present study. * Participant has a body mass index (BMI) range of 18 kg/m2 to 38 kg/m2 inclusive at screening. * Participant's condition is stable as determined on the basis of medical history and general physical examination (including a bimanual clinical pelvic examination devoid of relevant clinical findings performed at the screening visit), hematology and biochemistry parameters, pulse rate and/or blood pressure and electrocardiogram (ECG) (or showing no clinically relevant deviations obtained within the last 3 months or at screening). * Participant has no new clinically significant findings on breast examination or from imaging (mammogram or breast ultrasound). Results indicate that the participant is a good candidate for the study. Appropriate documentation includes a written or electronic report. In case of double mastectomy, imaging is not needed. * Participant has no clinically significant findings on a transvaginal ultrasound (TVU) result obtained within the last 3 months or at screening. Results indicate that the participant is a good candidate for the study. This is not required for participants who have had a partial (supra-cervical) or total hysterectomy. * Participant has a negative serology panel (including hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody and human immunodeficiency virus (HIV) antibody screens). Exclusion Criteria: * Participant has diagnosis of metastatic breast cancer (stage 4). * Participant has current or history (except complete remission for 5 years or more prior to signing informed consent) of any malignancy except for HR+ breast cancer (stage 0 to 3) or basal cell carcinoma. * Participant has had surgery or non-surgical (chemotherapy or radiotherapy) treatment for breast cancer within the last 3 months prior to signing informed consent. * Participant has active liver disease, jaundice, or elevated liver aminotransferases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST)), elevated total bilirubin (TBL) or direct bilirubin (DBL), elevated international normalized ratio (INR) or elevated alkaline phosphatase (ALP) at screening. A participant with mildly elevated ALT or AST up to \< 2 × upper limit of normal (ULN) can be enrolled if TBL and DBL are normal. Participant with mildly elevated ALP (up to \< 1.5 × ULN) can be enrolled if cholestatic liver disease is excluded and no cause other than fatty liver is diagnosed. Participant with Gilbert's syndrome with elevated TBL may be enrolled as long as DBL, hemoglobin and reticulocytes are normal. * Participant has creatinine \> 1.5 x ULN; or estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease formula \< 30 mL/min/1.73 m2 at the screening visit. * Participant has a history of endometrial hyperplasia or uterine/endometrial cancer. * Participant has a medical condition or chronic disease (including history of neurological \[including cognitive\], hepatic, renal, cardiovascular, gastrointestinal, pulmonary \[e.g., moderate asthma\], endocrine, or gynecological disease) or malignancy that could confound interpretation of the study outcome. * Participant uses a prohibited therapy (menopause hormone therapy (MHT), estradiol-containing hormonal contraceptive progestin and progesterone-only medicines, any treatment for VMS \[prescription medications, over-the-counter, or herbal\] or CYP1A2 (cytochrome P450) inhibitors) or is not willing to wash out such drugs; in addition, medications that are contraindicated due to underlying breast cancer diagnosis and the adjuvant endocrine therapy. * Participant has a known substance abuse or alcohol addiction within 6 months of screening. * Participant has received any investigational therapy within 90 days or 5 half-lives, whichever is longer, prior to screening. * Participant has any condition, which makes the participant unsuitable for study participation. * Participant has a known or suspected hypersensitivity to fezolinetant, the adjuvant endocrine therapy being used, or any components of the formulations used. **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Astellas Pharma Global Development, Inc. **Phone:** 800-888-7704 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Astellas Pharma Global Development, Inc. **Name:** Medical Director **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement. **Description:** Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com **Info Types:** - STUDY_PROTOCOL - SAP - CSR **IPD Sharing:** YES **Time Frame:** Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data. **URL:** https://www.clinicalstudydatarequest.com ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: LOW - As Found: Unknown - ID: M21519 - Name: Hot Flashes - Relevance: HIGH - As Found: Hot Flashes ### Condition Browse Module - Meshes - ID: D000019584 - Term: Hot Flashes ### Intervention Browse Module - Ancestors - ID: D000004965 - Term: Estrogen Antagonists - ID: D000006727 - Term: Hormone Antagonists - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018931 - Term: Antineoplastic Agents, Hormonal - ID: D000000970 - Term: Antineoplastic Agents - ID: D000020845 - Term: Selective Estrogen Receptor Modulators - ID: D000020847 - Term: Estrogen Receptor Modulators - ID: D000050071 - Term: Bone Density Conservation Agents - ID: D000065088 - Term: Steroid Synthesis Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: BDCA - Name: Bone Density Conservation Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M16403 - Name: Tamoxifen - Relevance: HIGH - As Found: Less than - ID: M25769 - Name: Aromatase Inhibitors - Relevance: HIGH - As Found: Antihypertensive - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M8116 - Name: Estrogens - Relevance: LOW - As Found: Unknown - ID: M8114 - Name: Estrogen Antagonists - Relevance: LOW - As Found: Unknown - ID: M30483 - Name: Estrogen Receptor Antagonists - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M20966 - Name: Antineoplastic Agents, Hormonal - Relevance: LOW - As Found: Unknown - ID: M22597 - Name: Selective Estrogen Receptor Modulators - Relevance: LOW - As Found: Unknown - ID: M22599 - Name: Estrogen Receptor Modulators - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000013629 - Term: Tamoxifen - ID: D000047072 - Term: Aromatase Inhibitors ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06440954 **Acronym:** EPIC **Brief Title:** Efficacy and Resistance Mechanisms of IP in NSCLC With Leptomeningeal Metastases **Official Title:** To Investigate the Efficacy and Resistance Mechanisms of Intrathecal Pemetrexed in Advanced Non-small Cell Lung Cancer (NSCLC) Patients Harboring Oncogenic Mutations With Leptomeningeal Metastases #### Organization Study ID Info **ID:** 20240442 #### Organization **Class:** OTHER **Full Name:** Hunan Province Tumor Hospital ### Status Module #### Completion Date **Date:** 2027-04-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-04-23 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Hunan Cancer Hospital #### Lead Sponsor **Class:** OTHER **Name:** Hunan Province Tumor Hospital #### Responsible Party **Investigator Affiliation:** Hunan Province Tumor Hospital **Investigator Full Name:** Yongchang Zhang **Investigator Title:** professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is a prospective interventional study clinical study to investigate the efficacy and resistance mechanisms of intrathecal pemetrexed in patients with driver gene mutations advanced NSCLC with leptomeningeal metastases. **Detailed Description:** This is a prospective interventional clinical study aimed at investigating the efficacy and resistance mechanisms of intrathecal pemetrexed in advanced NSCLC patients with EGFR, ALK, and ROS1 mutations presenting leptomeningeal metastases. Approximately 30 advanced NSCLC patients with EGFR, ALK, and ROS1 mutations, who have developed leptomeningeal metastases following TKI resistance, will receive intrathecal pemetrexed. Cerebrospinal fluid samples will be collected before and after pemetrexed resistance to analyze molecular mechanisms and differences. Second-generation gene detection will be performed to identify potential resistance mechanisms to pemetrexed. The study is expected to commence recruitment in mainland China around April 2024, with an anticipated completion date in April 2025. ### Conditions Module **Conditions:** - Non-Small Cell Lung Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 220 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Intrathecal pemetrexed **Intervention Names:** - Drug: Intrathecal pemetrexed **Label:** Intrathecal pemetrexed **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intrathecal pemetrexed **Description:** Intrathecal pemetrexed(50mg) twice a week for 1 week (day 1 and day 5) as induction treatment, then once monthly until progressive disease. **Name:** Intrathecal pemetrexed **Other Names:** - pemetrexed **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Overall Survival Time was defined as the duration from the start of IP to patient death **Measure:** Overall Survival Time **Time Frame:** Time from first subject dose to study completion, or up to 36 month #### Primary Outcomes **Description:** Intracranial progression-free survival was defined as the duration from the start of IP to the worsening of neurological symptoms, radiological confirmation of brain progression, or patient death **Measure:** Intracranial progression-free survival (I-PFS) **Time Frame:** Time from first subject dose to study completion, or up to 36 month #### Secondary Outcomes **Description:** System progression-free survival was defined as the duration from the start of IP to the worsening of neurological symptoms, radiological confirmation of brain progression, or patient death **Measure:** System progression-free survival (s-PFS) **Time Frame:** Time from first subject dose to study completion, or up to 36 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age ≥ 18 years. 2. Histopathology or cytology confirmed metastatic non-small cell lung cancer with leptomeningeal metastasis after TKI resistant. 3. EGFR mutant, ALK fusion, ROS1 fusion, and other oncogenic alterations including RET fusion, BRAF mutation, NTRK fusion, KRAS mutation was confirmed by an accredited local laboratory. 4. Adequate bone marrow hematopoiesis and organ function 5. Agree to receive intrathecal pemetrexed 6. ECOG 0 - 2. 7. Predicted survival ≥ 12 weeks. Exclusion Criteria: 1. Previously received intrathecal pemetrexed therapy for locally advanced or metastatic disease. 2. Subjects who have received any of the following treatments must be excluded: Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose. 3. Presence of spinal cord compression or meningeal metastasis. 4. History of other malignant tumors within 2 years. 5. Adverse events (except alopecia of any degree) of CTCAE \> grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose. 6. History of stroke or intracranial hemorrhage within 6 months prior to the first dose. 7. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator. 8. Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection. 9. Heart-related diseases or abnormalities 10. Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy. 11. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection. 12. Live vaccine was given 2 weeks before the first medication. 13. Women who are breastfeeding or pregnant. 14. Hypersensitivity to the test drug and the ingredients. 15. Other conditions assessed by the investigator to be unsuitable for participation 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:** Zhang Yongchang, professor **Phone:** 13873123436 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Liang Zeng **Phone:** 15974139200 **Role:** CONTACT #### Locations **Location 1:** **City:** Changsha **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yongchang Zhang, MD - **Phone:** +86 731 89762323 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Role:** CONTACT ***Contact 3:*** - **Name:** Yongchang Zhang, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** Hunan Cancer Hospital **State:** Hunan **Status:** RECRUITING **Zip:** 410013 #### Overall Officials **Official 1:** **Affiliation:** Hunan Cancer Hospital **Name:** Yongchang Zhang **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000002283 - Term: Carcinoma, Bronchogenic - ID: D000001984 - Term: Bronchial Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M11172 - Name: Lung Neoplasms - Relevance: HIGH - As Found: Lung Cancer - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: HIGH - As Found: Non-Small Cell Lung Cancer - ID: M12307 - Name: Neoplasm Metastasis - Relevance: LOW - As Found: Unknown - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M5540 - Name: Carcinoma, Bronchogenic - Relevance: LOW - As Found: Unknown - ID: M5260 - Name: Bronchial Neoplasms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008175 - Term: Lung Neoplasms - ID: D000002289 - Term: Carcinoma, Non-Small-Cell Lung ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - 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: M264 - Name: Pemetrexed - Relevance: HIGH - As Found: New - 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: D000068437 - Term: Pemetrexed ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06440941 **Brief Title:** Chatbot-based Mindfulness Programme for Depressive University Students: Pilot Intervention Study **Official Title:** Chatbot-based Mindfulness-based Stress Reduction Programme for University Students With Depressive Symptoms: Intervention Development and Pilot Evaluation #### Organization Study ID Info **ID:** HSEARS20221027007 #### Organization **Class:** OTHER **Full Name:** The Hong Kong Polytechnic University ### Status Module #### Completion Date **Date:** 2023-06-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-03-31 **Type:** ACTUAL #### Start Date **Date:** 2022-12-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The Hong Kong Polytechnic University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this study is to evaluate the feasibility, acceptability, safety and preliminary efficacy of a chatbot-based mindfulness-based stress reduction (MBSR) intervention for university students with depressive symptoms. A rule-based MBSR chatbot will be developed and evaluated with a single-group pretest-posttest study for university students aged 18 or above in Hong Kong reporting depressive symptoms, followed by the collection of their subjective feedback. The intervention will last eight weeks. The primary clinical outcome is depression levels, with a range of secondary outcomes including stress, anxiety and mindfulness levels. **Detailed Description:** Depression is a growing concern among university students. Chatbots provide flexible, accessible, personalized psychosocial support. Delivering Mindfulness-based Stress Reduction (MBSR) sessions via chatbots may reduce depressive symptoms in university students. This study consists of two phases. In the first phase, a rule-based automated chatbot will be developed to facilitate MBSR interventions. The second phase will employ a single-group pretest-posttest design to evaluate the feasibility, acceptability, safety and preliminary effectiveness of the chatbot-based MBSR intervention for university students with self-reported depressive symptoms. The study will be guided by the CONSORT 2010 checklist-extension for pilot and feasibility studies of information to include when reporting a pilot or feasibility trial. This study specifically targets university students in Hong Kong. Phase One: Development of the Chatbot-based MBSR Intervention Phase one focuses on developing a chatbot-based MBSR intervention using an interactive system named Power Virtual Agents, integrated within the Microsoft Teams platform. We will first conduct a comprehensive literature review to inform the integration of chatbot conversational flows with the content of MBSR sessions and craft a comprehensive chatbot-mediated conversational flow structure to guide participants through the MBSR sessions. The sessions will be delivered in audio format (Cantonese) via the chatbot programmed to operate in Traditional Chinese. Subsequently, we will employ a logical algorithm to establish coherent flows for the intervention sessions. Each session will be programmed with specific triggers, keywords, and queries to effectively engage users. The chatbot incorporates natural language understanding capabilities to analyze user input and guide the conversation accordingly. Additionally, a lightweight database will be integrated to track and maintain user progress and facilitate continuity across the MBSR sessions. The usability of the chatbot-based MBSR intervention will be evaluated through backend data analysis from the chatbot system and qualitative feedback from users. All steps will be supervised by the authors to ensure the reliability and accuracy of the development process. Phase Two: A Feasibility Clinical Trial Participant Recruitment Posters will be displayed across various key locations within our university. These posters include a concise overview of the study and a quick response (QR) code for assessing participant eligibility. Additionally, the study will be promoted on social media platforms such as Facebook and Instagram. Eligible participants who complete the programme will be offered coupons. The recruitment period is expected to extend for four months. Participate Screening Eligible participants must be students aged over 18 years pursuing a bachelor degree, associate degree, or higher diploma, with self-reported depressive symptoms. The depressive symptoms are assessed pre-intervention using the 9-item Patient Health Questionnaire, with cumulative scores of 5 or higher indicating depressive symptoms. Participants must also be able to provide informed consent, read Chinese, listen to Cantonese, and ensure internet access during the study. Participants will be excluded if they had been diagnosed with a clinical psychotic condition pre-intervention or are currently involved in any mindfulness-based or other psychosocial interventions. Sample Size According to previous single-group pre-post pilot studies, this study aims to recruit 20-40 participants to assess the feasibility, acceptability, and preliminary effectiveness of the chatbot-based MBSR programme. Intervention Development and Content Description Recruited participants need to sign consent forms and complete baseline assessments. Instructions for interacting with the chatbot via Microsoft TEAMS® will be provided. During the intervention, participants will first undergo a single-item assessment to verify the stability of their mental states for subsequent MBSR sessions, deemed stable if rated as excellent, very good or good; They will then engage in conversations with the chatbot, responding to prompts like What is the most recent thing that made you happy? to foster interactive communication and relaxation. Subsequently, participants need to follow guided MBSR sessions and are encouraged to interact with the chatbot for at least one hour daily; all interactions will be monitored and recorded. After eight weeks, a post-intervention assessment will be conducted, followed by pre-post statistical analyses. A total of ten participants with the most and least significant changes in depression levels will be selected for an open-ended questionnaire. Assessments Feasibility and Acceptability and Safety： The feasibility of participant recruitment and follow-up will be assessed through three metrics: (1) the time taken to recruit the target sample size; (2) the recruitment rate and (3) the retention rate. The acceptability of the intervention will be evaluated using the following criteria (1) adherence rate and (2) the specifically designed open-ended questionnaire for a targeted group of participants. The safety of the intervention will be evaluated by recording any adverse events reported by participants during the study and determining whether any events are directly associated with the intervention or with participation in the study more generally. Socio-demographics: Participant socio-demographics will be collected using a self-designed questionnaire, including gender, marital status, current grade level, religion, faculty, year of study, living situation, and personal net monthly income. Primary Clinical Outcome: Depression: The depression levels of the participants will be assessed using the Patient Health Questionnaire (PHQ-9) in Chinese. Secondary Clinical Outcomes: Stress: The stress levels of the participants will be evaluated with the Perceived Stress Scale (PSS-14) in Chinese. Anxiety: The anxiety levels of the participants will be measured using the Generalized Anxiety Disorder Scale (GAD-7) in Chinese. Mindfulness: The mindfulness levels of the participants will be assessed using the Five-Facet Mindfulness Questionnaire (FFMQ-39) in Chinese. Statistical Analysis Descriptive statistics will be used to summarize participant demographic information and total scores on different assessment tools. Statistical analysis will be conducted using Statistical Package for the Social Sciences (SPSS), version 27.0 (IBM Corp). The Shapiro-Wilk test will be employed to assess the normality of continuous data, including scores from the PHQ-9, PSS-14, GAD-7, and FFMQ. Subsequently, a t-test will be performed to evaluate changes between pre- and post-intervention scores for these measures. A chi-square test will be used to identify the severity differences regarding depression, anxiety and stress levels. A p-value of ≤.05 is considered statistically significant. Imputation will be considered for missing values. Participant responses to open-ended questions will be compiled and analyzed to gather feedback. Ethical consideration This study will be conducted in accordance with the Declaration of Helsinki. Ethical approval for this study was granted by the Hong Kong Polytechnic University Human Subjects Ethics Review Board (No. HSEARS20221027007). Before the baseline assessments, all participants need to provide informed consent, confirming their participation and their understanding of their right to withdraw at any time without penalty. Participants will be assured of confidentiality, with their identities and data protected anonymously. Only authorized personnel have access to the data for analysis. Participants will be informed about the likelihood of encountering emotional distress during the study and will be encouraged to report any discomfort to the research team. If necessary, participants would be referred to clinical mental health services. All data collected from the chatbot will be de-identified. Usage data will be aggregated and not linked to specific participants. Implications for Practice The pilot findings of this study will lay the groundwork for developing a more optimized chatbot intervention in future research. All data and feedback collected in this pilot study will be used to refine the application of MBSR for a future clinical trial examining its efficacy. Insights from this chatbot-based MBSR programme will also inform researchers and healthcare professionals to develop innovative digital mental health interventions to address the rising mental health challenges among university students. ### Conditions Module **Conditions:** - Depression **Keywords:** - Mindfulness - Chatbot - Depression - University Student ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 30 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This study consists of two phases. In the first phase, a rule-based automated chatbot will be developed to facilitate mindfulness-based stress reduction (MBSR) interventions. The second phase will employ a single-group pretest-posttest design to evaluate the feasibility, acceptability, safety and preliminary efficacy of the chatbot-based MBSR intervention for university students with self-reported depressive symptoms. The study will be guided by the 'CONSORT 2010 checklist of information to include when reporting a pilot or feasibility trial'. This study specifically targets university students in Hong Kong and the intervention lasts eight weeks. **Intervention Names:** - Other: chatbot-based mindfulness-based stress reduction **Label:** one arm pre-post test **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - one arm pre-post test **Description:** During the intervention, participants will be involved in a developed chatbot and undergo a single-item assessment to verify the stability of their mental states for subsequent mindfulness-based stress reduction (MBSR) sessions, deemed stable if rated as excellent, very good, or good; They will then engage in conversations with the chatbot, responding to prompts like What is the most recent thing that made you happy? to foster interactive communication and relaxation. Subsequently, participants need to follow guided MBSR sessions and are encouraged to interact with the chatbot for at least one hour daily; all interactions will be monitored and recorded. After eight weeks, a post-intervention assessment will be conducted, followed by pre-post statistical analyses. A total of ten participants with the most and least significant changes in depression levels will be selected for an open-ended questionnaire. **Name:** chatbot-based mindfulness-based stress reduction **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The depression levels of the participants will be assessed using the Patient Health Questionnaire (PHQ-9) in Chinese. Items are rated on a scale from 0 (not at all) to 3 (nearly every day), with total scores categorizing depression severity: 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), and ≥20 (severe). Higher scores mean a worse outcome. **Measure:** Patient Health Questionnaire (PHQ-9) **Time Frame:** The pre-intervention/baseline assessment using this measure will be conducted one week before the start of the intervention. The post-intervention assessment using this measure will be conducted upon the completion of the 8-week intervention. #### Secondary Outcomes **Description:** The anxiety levels of the participants will be measured using the Generalized Anxiety Disorder Scale (GAD-7) in Chinese. Items are rated on a scale from 0 (not at all) to 3 (nearly every day), with total scores categorizing anxiety severity as minimal (0-4), mild (5-9), moderate (10-14), and severe (≥15). Higher scores mean a worse outcome. **Measure:** Generalized Anxiety Disorder Scale (GAD-7) **Time Frame:** The pre-intervention/baseline assessment using this measure will be conducted one week before the start of the intervention. The post-intervention assessment using this measure will be conducted upon the completion of the 8-week intervention. **Description:** The stress levels of the participants will be evaluated with the Perceived Stress Scale (PSS-14) in Chinese. It uses a 5-point Likert scale ranging from 0 (never) to 4 (very often), categorizing total scores into low stress (0-13), moderate stress (14-26), and high stress (27-40). Higher scores mean a worse outcome. **Measure:** Perceived Stress Scale (PSS-14) **Time Frame:** The pre-intervention/baseline assessment using this measure will be conducted one week before the start of the intervention. The post-intervention assessment using this measure will be conducted upon the completion of the 8-week intervention. **Description:** The mindfulness levels of the participants will be assessed using the Five-Facet Mindfulness Questionnaire (FFMQ-39) in Chinese, which rates items from 1 (never or very rarely true) to 5 (very often or always true) across five facets: observing, describing, acting with awareness, non-judgmental, and nonreactivity. Higher scores mean a better outcome. **Measure:** Five-Facet Mindfulness Questionnaire (FFMQ-39) **Time Frame:** The pre-intervention/baseline assessment using this measure will be conducted one week before the start of the intervention. The post-intervention assessment using this measure will be conducted upon the completion of the 8-week intervention. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * University students aged over 18 years * University students pursuing a bachelor degree, associate degree, or higher diploma in Hong Kong * University students with self-reported depressive symptoms (The depressive symptoms are assessed pre-intervention using the 9-item Patient Health Questionnaire, with cumulative scores of 5 or higher indicating at least mild depressive symptoms.) * Be able to provide informed consent, read Chinese, listen to Cantonese * Ensure internet access during the study Exclusion Criteria: * University students who have been diagnosed with a clinical psychotic condition pre-intervention * University students who are currently involved in any mindfulness-based or other psychosocial interventions **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Hong Kong **Country:** Hong Kong **Facility:** School of Nursing, The Hong Kong Polytechnic Unviersity ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - 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: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003863 - Term: Depression ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06440928 **Brief Title:** Results of Cervical Segmental Mobilization in Patients With Chronic Lateral Epicondylitis **Official Title:** Investigation of the Effect of Cervical Segmental Mobilization on Pain, Functionality, Grip Strength and Quality of Life in Patients With Chronic Lateral Epicondylitis #### Organization Study ID Info **ID:** 2023/106 #### Organization **Class:** OTHER **Full Name:** Halic University ### Status Module #### Completion Date **Date:** 2024-10-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-03 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-08-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-05 **Study First Submit QC Date:** 2024-06-03 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Halic University #### Responsible Party **Investigator Affiliation:** Halic University **Investigator Full Name:** Mustafa Yığılıtaş **Investigator Title:** lecturer **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The aim of our study was to investigate the effect of cervical segmental mobilization on pain, functionality, grip strength and quality of life in patients with chronic lateral epicondylitis. It was planned as a randomized controlled experimental study. ### Conditions Module **Conditions:** - Epicondylitis of the Elbow - Servical Segmental Mobilization **Keywords:** - Lateral epicondylitis - Servical segmental mobilization - Pain - Quality of life - Grip strenght - Functionality ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** randomised controlled and experimental study ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Mobilisation specifically on the C7 segment will be performed by the physiotherapist 2 times a week for 3 weeks, making decisions on the choice of key parameters including treatment technique, spinal level, degree, direction, side and duration. **Intervention Names:** - Behavioral: mobilization - Other: standard treatment **Label:** intervention grup: standart treatment and segmental mobilization grup **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The patients were asked to stretch for 20 s with the other hand with the shoulder in internal rotation, elbow in extension, forearm in pronation, wrist in flexion and ulnar deviation. In the first week, stretching exercises were recommended to be performed 3 sets a day, 5⨯20 s in one set and 45 s rest interval before strengthening exercises. The application will be performed with the thumb in the transverse direction, with the pressure tolerated by the individual, for 10 minutes after numbness is obtained, the treatment lasts approximately 10-15 minutes. **Intervention Names:** - Other: standard treatment - Other: deep friction **Label:** intervention grup : standart treatment and deep friction **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** The patients were asked to stretch for 20 s with the other hand with the shoulder in internal rotation, elbow in extension, forearm in pronation, wrist in flexion and ulnar deviation. In the first week, stretching exercises were recommended to be performed 3 sets a day, 5⨯20 s in one set and 45 s rest interval before strengthening exercises. Starting from the 2nd week of treatment, it will be requested to be performed 3 sets a day, 5⨯20 s in one set, 5⨯20 s before exercise and 5⨯20 s after exercise. **Intervention Names:** - Other: standard treatment **Label:** intervention grup: standart treatment. **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - intervention grup: standart treatment and segmental mobilization grup **Description:** mobilization and exercise to be applied to patients with chronic lateral epicondylitis **Name:** mobilization **Other Names:** - excersize **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - intervention grup : standart treatment and deep friction - intervention grup: standart treatment and segmental mobilization grup - intervention grup: standart treatment. **Description:** standard treatment **Name:** standard treatment **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - intervention grup : standart treatment and deep friction **Description:** deep friction **Name:** deep friction **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** In the assessment of pain, the "Visuel Analog Scale (VAS)" will be used and people will be asked to indicate the severity of their pain in the last 24 hours on a 10 cm chart. Before and after the session, VAS will be evaluated and recorded with the values measured with algometer. According to the pain scale in VAS application; "0" means no pain and "10" means the presence of unbearable pain, while patients will be asked to mark the pain they feel numerically between 0-10. **Measure:** Assessment of Pain **Time Frame:** 3 weeks **Description:** The scale consists of 36 statements. The scale has 8 dimensions including physical functioning (FF), social functioning (SF), role limitations related to physical functioning (RRF), role limitations related to emotional problems (ERR), mental health (MS), vitality (C), bodily pain (BA) and general health perception (GS). Quality of life increases as the scores on the scale increase. Minimum score is 0 and maximum score is 100. **Measure:** Quality of Life Short Form-36 **Time Frame:** 3 weeks **Description:** Duruöz Hand Index (DEI) specifically for rheumatoid arthritis patients. The index includes hand dexterity in the kitchen, during dressing, while maintaining personal hygiene, at work and other general movements. Participants rate 18 items from 0 (no difficulty) to 5 (impossible to do). The total score ranges from 0-90. A high score indicates impaired hand function. **Measure:** Assessment of Functionality **Time Frame:** 3 weeks **Description:** Grip strength will be evaluated with Jamar Hand Dynamometer. In the grip strength evaluations of the hand, measurements will be taken from both the patient and the healthy side. In the measurements made from the patient side, painless grip strength and maximum grip strength will be evaluated separately in the elbow flexion position and elbow extension position. On the healthy side, maximum grip strength will be evaluated in both positions. Patients will be positioned and evaluated according to the holding and gripping force of the dynamometer to be used. The patient will be asked to squeeze the dynamometer as strongly as possible for 5 seconds, first with the intact and then with the affected side, and 3 measurements will be made with one-minute breaks between the measurements and the averages will be recorded. **Measure:** Grip Strength **Time Frame:** 3 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Being between the ages of 25-44 * Being diagnosed with LE by a physician * Not having any defined pathology in the cervical region * No neurological problems in the upper extremities * No history of cervical surgery Exclusion Criteria: * Those with a history of infection, tumor, trauma in the cervical area * Fibromyalgia patients * Congenital or acquired deformities of the upper extremity * History of shoulder or elbow surgery or dislocation * Cervical radiculopathy * Having had Wiplash **Maximum Age:** 44 Years **Minimum Age:** 25 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** mustafa yığılıtaş, doctorate **Phone:** 05309782720 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** seda saka, asst.prof **Role:** CONTACT #### Locations **Location 1:** **City:** Yalova **Contacts:** ***Contact 1:*** - **Name:** Mustafa Yığılıtaş, Doctorate - **Phone:** 05309782720 - **Role:** CONTACT **Country:** Turkey **Facility:** Yalova University **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000070639 - Term: Elbow Tendinopathy - ID: D000052256 - Term: Tendinopathy - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000092464 - Term: Elbow Injuries - ID: D000001134 - Term: Arm Injuries - ID: D000014947 - Term: Wounds and Injuries - ID: D000013708 - Term: Tendon Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M10295 - Name: Influenza, Human - Relevance: LOW - As Found: Unknown - ID: M16486 - Name: Tennis Elbow - Relevance: HIGH - As Found: Lateral Epicondylitis - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M27013 - Name: Tendinopathy - Relevance: LOW - As Found: Unknown - ID: M627 - Name: Elbow Tendinopathy - 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: M2926 - Name: Elbow Injuries - Relevance: LOW - As Found: Unknown - ID: M4444 - Name: Arm Injuries - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M16479 - Name: Tendon Injuries - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013716 - Term: Tennis Elbow ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06440915 **Brief Title:** Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children **Official Title:** Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children #### Organization Study ID Info **ID:** YJK-001 #### Organization **Class:** OTHER **Full Name:** Shanghai Children's Medical Center ### Status Module #### Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-01 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-06-01 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Shanghai Children's Medical Center #### Responsible Party **Investigator Affiliation:** Shanghai Children's Medical Center **Investigator Full Name:** Juan Wu, PhD **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 this clinical trial is to learn the plasma concentration of isavuconazole in pediatric patients. It will also learn about the relationship of isavuconazole plasma concentrations to efficacy and safety in pediatric patients. The main questions it aims to answer are: What is the plasma concentration after using isavuconazole in pediatric patients? What is the effective range of plasma concentration of isavuconazole in pediatric patients? What is the safe range of plasma concentration of isavuconazole in pediatric patients? Researchers will measure the plasma concentration of isavuconazole to see whether it is appropriate. Participants will: Take drug isavuconazole as prescribed by the doctor; 1mL of blood is drawn 30min before the next dose. **Detailed Description:** Objectives of Study: Main objective: To monitor the plasma concentration of isavuconazole in children, and to study the pharmacokinetic characteristics of isavuconazole in children, so as to provide basis for the optimization of individualized drug administration. Secondary objective: To evaluate the relevance of isavuconazole plasma concentrations to efficacy and safety in pediatric patients. ### Conditions Module **Conditions:** - Aspergillosis Invasive - Mucormycosis ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SEQUENTIAL ##### 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:** Theraputic drug monitoring **Intervention Names:** - Other: Theraputic drug monitoring - Drug: Isavuconazole **Label:** Isavuconazole group **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Isavuconazole group **Description:** High Performance Liquid Chromatography (HPLC) is used to determine the plasma concentrations of isavuconazole **Name:** Theraputic drug monitoring **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Isavuconazole group **Description:** Isavuconazole **Name:** Isavuconazole **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** High Performance Liquid Chromatography is used to determine the plasma concentrations of isavuconazole **Measure:** Plasma concentrations of isavuconazole **Time Frame:** 30 minutes before next dosing #### Secondary Outcomes **Description:** Percentage of patients who were assessed by the study physician as clinically cured and improved **Measure:** Treatment success rates for IMI **Time Frame:** 6 months **Description:** Number and percentage of AE and SAE **Measure:** AE and SAE **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients who intend to take isavuconazole for the treatment of invasive mycosis; * Aged 0-18 years, gender unlimited; * The subject and his/her guardian are willing to comply with the procedures and operations specified in the study protocol; * The guardian of the subject and the subject of independent informed age are willing and able to provide written informed consent to participate in the study. Exclusion Criteria: * The subject is known to be allergic to any azole antifungal therapy or other ingredients contained in the study drug; * The researcher believes that the condition of the child may interfere with study participation or other inappropriate conditions. **Maximum Age:** 18 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Juan Wu, PhD **Phone:** +8618918397709 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Shanghai Children's Medical Center **Name:** Juan Wu, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Contact the investigator for request **Description:** Date of sharing: after publication of the study results; Way of sharing: Contact the investigator for request **Info Types:** - STUDY_PROTOCOL - CSR **IPD Sharing:** YES **Time Frame:** After publication of the study results ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009181 - Term: Mycoses - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000007239 - Term: Infections - ID: D000020096 - Term: Zygomycosis ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4535 - Name: Aspergillosis - Relevance: HIGH - As Found: Aspergillosis - ID: M12048 - Name: Mucormycosis - Relevance: HIGH - As Found: Mucormycosis - ID: M21934 - Name: Zygomycosis - Relevance: LOW - As Found: Unknown - 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: T511 - Name: Aspergillosis - Relevance: HIGH - As Found: Aspergillosis - ID: T3913 - Name: Mucormycosis - Relevance: HIGH - As Found: Mucormycosis ### Condition Browse Module - Meshes - ID: D000001228 - Term: Aspergillosis - ID: D000009091 - Term: Mucormycosis ### Intervention Browse Module - Ancestors - ID: D000000935 - Term: Antifungal Agents - ID: D000000890 - Term: Anti-Infective Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M349205 - Name: Isavuconazole - Relevance: HIGH - As Found: Represent - 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 ### Intervention Browse Module - Meshes - ID: C000508735 - Term: Isavuconazole ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06440902 **Brief Title:** Exploration of Therapeutic Strategies for NeoRAS Wild-type Metastatic Colorectal Cancer Based on Circulating Tumor DNA **Official Title:** Exploration of Therapeutic Strategies for NeoRAS Wild-type Metastatic Colorectal Cancer Based on Circulating Tumor DNA: an Open, Prospective, Phase II Study #### Organization Study ID Info **ID:** ctDNA-neoRASCRC #### Organization **Class:** OTHER **Full Name:** Fudan University ### Status Module #### Completion Date **Date:** 2028-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2028-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-12-28 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-02-22 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Fudan University #### Responsible Party **Investigator Affiliation:** Fudan University **Investigator Full Name:** Junjie Peng **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Following systemic therapy in metastatic colorectal cancer(mCRC),RAS (including KRAS, NRAS and HRAS gene) status may change from a mutant(MT) to a wild-type(WT),a phenomenon known as "NeoRAS WT"mCRC.NeoRAS WT can be detected by longitudinal circulating tumor DNA(ctDNA) analysis.Therefore, this prospective phase II Study was design to explore the detection rate of peripheral blood ctDNA testing for NeoRAS WT and its guiding value for subsequent treatment for mCRC. ### Conditions Module **Conditions:** - Colorectal Cancer Metastatic ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 1100 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** RAS mutated metastatic colorectal cancer were routinely treated after enrollment. When the disease progression was confirmed by imaging, peripheral blood ctDNA detection was performed to observe whether they were transformed into NeoRAS wild-type patients. If NeoRAS wild- type was detected, the anti-EGFR therapy may be considered as the following therapy for patients. **Intervention Names:** - Drug: Cetuximab **Label:** RAS mutated metastatic colorectal cancer **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - RAS mutated metastatic colorectal cancer **Description:** Cetuximab is given In patients with NeoRAS WT **Name:** Cetuximab **Other Names:** - C225 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Proportion of occurrence of neoRAS WT **Measure:** Detection rate of NeoRAS WT **Time Frame:** up to 60 months #### Secondary Outcomes **Description:** Objective response rate of NeoRAS wild-type patients receiving anti-EGFR (epidermal growth factor receptor) therapy **Measure:** Objective response rate(ORR) of NeoRAS wild-type patients receiving anti-EGFR therapy **Time Frame:** Follow-up was conducted for 2 years after enrollment **Description:** Progression-free survival (PFS) : time from enrollment to disease progression from any cause **Measure:** Progression-free survival (PFS) in NeoRAS WT patients **Time Frame:** Follow-up was conducted for 2 years after enrollment **Description:** Overall survival (OS) : time from enrollment to death from any cause, loss of participants, and time of last follow-up **Measure:** Overall survival (OS) in NeoRAS WT patients **Time Frame:** Follow-up was conducted for 2 years after enrollment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Metastatic colorectal cancer with tissue RAS mutation-type; 2. ECOG (Eastern Cooperative Oncology Group) performance score is 0-1; 3. Obtaining informed consent; 4. Surgical specimens or punctured tissue specimens containing tumors can be obtained; 10ml of peripheral blood can be obtained Exclusion Criteria: 1. The pathology was not confirmed by colonoscopy biopsy or biopsy of metastasis; 2. Colorectal cancer patients with clinical stage I-III;Patients with RAS wild-type metastatic colorectal cancer confirmed by histological genetic testing;Lack of adequate organ functions, such as severe abnormalities in blood, liver and kidney function **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Junjie Peng, PhD **Phone:** +86 13917373312 **Role:** CONTACT #### Locations **Location 1:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Junjie Peng, PhD - **Phone:** +86 13917373312 - **Role:** CONTACT **Country:** China **Facility:** Fudan University Shanghai Cancer Center **State:** Shanghai **Status:** RECRUITING **Zip:** 200032 #### Overall Officials **Official 1:** **Affiliation:** Fudan University **Name:** Junjie Peng, PhD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. **PMID:** 33538338 **Citation:** Osumi H, Takashima A, Ooki A, Yoshinari Y, Wakatsuki T, Hirano H, Nakayama I, Okita N, Sawada R, Ouchi K, Fukuda K, Fukuoka S, Ogura M, Takahari D, Chin K, Shoji H, Kato K, Ishizuka N, Boku N, Yamaguchi K, Shinozaki E. A multi-institutional observational study evaluating the incidence and the clinicopathological characteristics of NeoRAS wild-type metastatic colorectal cancer. Transl Oncol. 2023 Sep;35:101718. doi: 10.1016/j.tranon.2023.101718. Epub 2023 Jun 24. **PMID:** 37364334 **Citation:** Nicolazzo C, Magri V, Marino L, Belardinilli F, Di Nicolantonio F, De Renzi G, Caponnetto S, De Meo M, Giannini G, Santini D, Cortesi E, Gazzaniga P. Genomic landscape and survival analysis of ctDNA "neo-RAS wild-type" patients with originally RAS mutant metastatic colorectal cancer. Front Oncol. 2023 Mar 29;13:1160673. doi: 10.3389/fonc.2023.1160673. eCollection 2023. **PMID:** 37064137 **Citation:** Osumi H, Vecchione L, Keilholz U, Vollbrecht C, Alig AHS, von Einem JC, Stahler A, Striefler JK, Kurreck A, Kind A, Modest DP, Stintzing S, Jelas I. NeoRAS wild-type in metastatic colorectal cancer: Myth or truth?-Case series and review of the literature. Eur J Cancer. 2021 Aug;153:86-95. doi: 10.1016/j.ejca.2021.05.010. Epub 2021 Jun 18. **PMID:** 34153718 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007414 - Term: Intestinal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000012002 - Term: Rectal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M17890 - Name: Colorectal Neoplasms - Relevance: HIGH - As Found: Colorectal Cancer - ID: M10448 - Name: Intestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M14844 - Name: Rectal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015179 - Term: Colorectal Neoplasms ### Intervention Browse Module - 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: M315 - Name: Cetuximab - Relevance: HIGH - As Found: Side - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000068818 - Term: Cetuximab ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06440889 **Brief Title:** A Clinical Study to Determine the Safety and Efficacy of Bio-Ray Knee Guard in Panelists With Varicose Vein and Knee Pain. **Official Title:** Prospective, Open-Label, Control-group, Proof-Of-Science, Real-life Setting, Clinical Safety and Efficacy Study of a Bio-Ray Knee Guard in Panelists With Varicose Vein and Self-Declared Knee Pain. #### Organization Study ID Info **ID:** NB240023-WU #### Organization **Class:** OTHER **Full Name:** NovoBliss Research Pvt Ltd ### Status Module #### Completion Date **Date:** 2024-07-21 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-01 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-06-21 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-25 **Type:** ESTIMATED **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-06-01 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Winnox Cosmeceutics Sdn. Bhd #### Lead Sponsor **Class:** OTHER **Name:** NovoBliss Research Pvt Ltd #### Responsible Party **Investigator Affiliation:** NovoBliss Research Pvt Ltd **Investigator Full Name:** Dr Nayan Patel **Investigator Title:** Sub-Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Prospective, Open-Label, Control-group, Proof-Of-Science, Real-life Setting Clinical Safety and Efficacy Study of a Bio-Ray Knee Guard in Panelists with varicose vein and Self-Declared Knee Pain. Sample size for this proof-of-science study is kept 32 panelists aged 35 to 70 years with self-declared knee pain and varicose veins will be enrolled and 32 healthy panelists will be enrolled. **Detailed Description:** Potential panelists will undergo screening based on predefined inclusion and exclusion criteria only after obtaining written informed consent. Panelists shall be instructed to visit the facility for the following scheduled visits: Visit 01 (Day 01): Screening, enrolment, evaluations at baseline, test product and \*subject diary distribution, followed by evaluations after 1 hour (+10 minutes). Visit 02 (Day 03 +1 day): Evaluations at Day 03 (+1 day). Visit 03 (07 ±2 days): 1-week evaluations at Day 07 (±2 days). Visit 04 (28±2 days): Subject diary review, followed by end of study evaluations. ### Conditions Module **Conditions:** - Varicose Veins With Self-declared Knee Pain ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Prospective, Open-Label, Control-group, Proof-Of-Science, Real-life Setting, Clinical Safety and Efficacy Study ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 62 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Ebene Bio-Ray Knee Guard Wear the test product in the daytime for about 1-2 hours. Then, proceed to gradually lengthen the duration of wear to 4-6 and 6-8 hours. **Intervention Names:** - Device: Bio-Ray Knee Guard **Label:** Varicose Vein Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Ebene Bio-Ray Knee Guard Wear the test product in the daytime for about 1-2 hours. Then, proceed to gradually lengthen the duration of wear to 4-6 and 6-8 hours. **Intervention Names:** - Device: Bio-Ray Knee Guard **Label:** Healthy Group **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Healthy Group - Varicose Vein Group **Description:** Wear the metal guard (test product) for 1-2 hours during the first week, and then for 6-8 hours thereafter. (minimum for 4 hours) **Name:** Bio-Ray Knee Guard **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** To assess the effectiveness of the test product in terms of determining the biomarker D-dimer. **Measure:** Change in Blood Parameters (D-dimer) **Time Frame:** On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group. **Description:** To assess the effectiveness of the test product in terms of determining the biomarker C-reactive protein. **Measure:** Change in Blood Parameters (C-reactive protein) **Time Frame:** On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group. **Description:** To assess the effectiveness of the test product in terms of determining the biomarker rheumatoid factor. **Measure:** Change in Blood Parameters (Rheumatoid factor) **Time Frame:** On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group. **Description:** To assess the effectiveness of the test product in terms of determining the biomarker anti-CCP antibodies. **Measure:** Change in Blood Parameters (anti-CCP antibodies) **Time Frame:** On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group. **Description:** To assess the effectiveness of the test product in terms of determining the biomarker MCP-1. **Measure:** Change in Blood Parameters (MCP-1) **Time Frame:** On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group. **Description:** To assess the effectiveness of the test product in terms of determining the biomarker IL-6. **Measure:** Change in Blood Parameters (IL-6) **Time Frame:** On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group. **Description:** To assess the effectiveness of the test product in terms of determining the biomarker TNF-α. **Measure:** Change in Blood Parameters (TNF-α) **Time Frame:** On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group. **Description:** To assess the effectiveness of the test product in terms of change in blood circulation of saphenofemoral junction by duplex ultrasound. **Measure:** Change in Blood Circulation (SFJ) **Time Frame:** On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group. **Description:** To assess the effectiveness of the test product in terms of change in blood circulation of great saphenous vein by duplex ultrasound. **Measure:** Change in Blood Circulation (GSV) **Time Frame:** On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group. **Description:** To assess the effectiveness of the test product in terms of change in blood circulation of small saphenous veins by duplex ultrasound. **Measure:** Change in Blood Circulation (SSV) **Time Frame:** On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group. **Description:** To assess the effectiveness of the test product in terms of change in blood valve function of saphenofemoral junction by duplex ultrasound. **Measure:** Change in blood valve function (SFJ) **Time Frame:** On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group. **Description:** To assess the effectiveness of the test product in terms of change in blood valve function of great saphenous vein by duplex ultrasound. **Measure:** Change in blood valve function (GSV) **Time Frame:** On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group. **Description:** To assess the effectiveness of the test product in terms of change in blood valve function of small saphenous vein by duplex ultrasound. **Measure:** Change in blood valve function (SSV) **Time Frame:** On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group. **Description:** To assess the effectiveness of the test product in terms of change in vessel anatomy of saphenofemoral junction by duplex ultrasound. **Measure:** Change in vessel anatomy (SFJ) **Time Frame:** On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group. **Description:** To assess the effectiveness of the test product in terms of change in vessel anatomy of great saphenous vein by duplex ultrasound. **Measure:** Change in vessel anatomy (GSV) **Time Frame:** On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group. **Description:** To assess the effectiveness of the test product in terms of change in vessel anatomy of small saphenous vein by duplex ultrasound. **Measure:** Change in vessel anatomy (SSV) **Time Frame:** On Day 01 (Baseline) before usage and at Day 28 (±2 days) of test product usage, within group and between group. **Description:** To assess the effectiveness of the test product in terms of change in overall health of knee joint based on questionnaire. **Measure:** Change in overall health of knee joint. **Time Frame:** On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage. **Description:** To assess the effectiveness of the test product in terms of change in VAS pain score of Knee. Where 0= No pain 10 = worst pain **Measure:** Change in VAS pain score (only for vericose vain panelist) **Time Frame:** On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage. **Description:** To assess effectiveness of the test product in terms of change in CEAP classification of the severity of varicose vein. C0 = No visible or palpable signs of venous disease, C1= Telangiectasias or reticular veins C2 = Varicose vein and **Measure:** Change in CEAP classification (Clinical-Etiology-Anatomy-Pathophysiology) **Time Frame:** On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage. #### Secondary Outcomes **Description:** To assess the effectiveness of the test product in terms of change in blood pressure of upper leg (standing or sitting). **Measure:** Change in blood pressure **Time Frame:** On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage, within group and between group. **Description:** To assess the effectiveness of the test product in terms of change in blood pressure of lower leg (standing or sitting). **Measure:** Change in blood pressure **Time Frame:** On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage, within group and between group. **Description:** To assess the effectiveness of the test product in terms of change in ankle-brachial index. **Measure:** Change in ankle-brachial index **Time Frame:** On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage, within group and between group. **Description:** To assess the effectiveness of the test product in terms of change in body leg temperature by Infrared camera (thermal image). **Measure:** Change in body leg temperature **Time Frame:** On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage, within group and between group. **Description:** To assess the effectiveness of the test product in terms of overall improvement in symptoms and satisfaction with the use of test product using subjective perception questionnaire. **Measure:** Overall improvement in symptoms and satisfaction with the use of test product **Time Frame:** On Day 01 (Baseline) before usage, at 1-hour (+10 minutes), Day 03 (+1 days), Day 07 (±2 days) and Day 28 (±2 days) of test product usage. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Panelists of either gender, aged from 35 to 70 years (both inclusive) at the time of informed consent. 2. Non-pregnant and non-lactating adult females having a self-reported negative urine pregnancy test. 3. Panelist of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, vasectomy or abstinence). 4. 32 panelists with clinical diagnosis of varicose veins in any of the leg with C2 class as per CEAP classification (Appendix II), with self-declared knee pain. 5. 32 healthy panelists will be enrolled. 6. Documented written informed consent from the panelists. 7. Panelists having willingness and ability to adhere to study directions, and agreeing not to use any other or wear any other similar product at the same designated site for this study and returning for all specified visits for follow-up. 8. Panelists are currently not enrolled in an active investigational study or have participated in similar investigational study within 30 days prior to enrolment. Exclusion Criteria: 1. Any significant or serious cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological or psychiatric disease which, in the opinion of the PI, renders the panelists unfit to take part in the study. 2. Any recent surgery which may hinder in the study specific assessments and overall outcome. 3. Panelists with class C3 to C6 of CEAP classification. 4. Panelists who are currently on medication therapy for varicose veins, deep vein thrombosis or chronic venous insufficiency. 5. Panelists taking or have taken medication(s) which, in the Investigator's judgment, make them ineligible or places them at undue risk. 6. Panelists are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrolment. 7. Females who are pregnant or breastfeeding or planning to become pregnant during the study period. 8. Panelists who are not willing to adhere to the study protocol. **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 35 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Maheshvari N Patel **Phone:** 9909013236 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Sheetal J Khandwala J Khandwala **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** NovoBliss Research Pvt Ltd **Name:** Dr. Nayan K Patel K Patel **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 ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M17396 - Name: Varicose Veins - Relevance: HIGH - As Found: Varicose Veins - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014648 - Term: Varicose Veins ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06440876 **Acronym:** IMAGINE **Brief Title:** Music and Imagery for Veterans With Migraine Headache **Official Title:** Interactive Music And Guided Imagery for Nonpharma Headache Ease #### Organization Study ID Info **ID:** 19092 #### Organization **Class:** FED **Full Name:** Richard L. Roudebush VA Medical Center ### Status Module #### Completion Date **Date:** 2025-08-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-28 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Collaborators **Class:** FED **Name:** VA Connecticut Healthcare System #### Lead Sponsor **Class:** FED **Name:** Richard L. Roudebush VA Medical Center #### Responsible Party **Investigator Affiliation:** Richard L. Roudebush VA Medical Center **Investigator Full Name:** Kristin Story **Investigator Title:** Kristin Maya Story **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to determine feasibility and acceptability of telehealth music imagery for migraine (Aim 1) and to explore whether there are clinically meaningful changes in headache frequency and associated patient-centered outcomes (Aim 2). **Detailed Description:** IMAGINE is a single arm pilot trial. At least 10 and up to 25 Veterans with migraine headache will participate in 8-weekly one-to-one telehealth MI sessions. Sessions will be conducted via a private channel in VA Microsoft Teams, which is a VA approved platform. Each 60-minute MI session is facilitated by a music therapist and consists of 1) a verbal check-in 2) music listening (Veteran patient and therapist choose music together) 3) processing imagery elicited by music, which is done through optional artwork or discussion of the imagery 4) identification of ways to continue to work with music and imagery independently between sessions. Feasibility metrics related to recruitment, retention, engagement, and completion of treatment protocols and assessments will be evaluated. Acceptability will be measured through brief feedback from participant interviews. Qualitative interviews will be conducted to attain Veteran experiences, including perceived benefits, barriers and facilitators. Interview transcripts will be coded and analyzed for emergent themes. Aim 2 outcomes will be explored through changes in headache frequency and associated symptoms from baseline to follow-up immediately following completion of MI sessions. Descriptive statistics will be used to report outcomes. This study is not powered to detect differences in outcomes. ### Conditions Module **Conditions:** - Migraine ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 25 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** MI sessions will be delivered by board-certified music therapists with specialized training in MI and the study treatment protocol. The 8-session protocol has two stages. Stage 1 (sessions 1-4) is focused on learning to use music and imagery for self-regulation. Once the Veteran has demonstrated skill in using music for self-regulation, Stage 2 (sessions 5-8) shifts to identify and deepen their inner resources and how they can use those resources for self-care. **Intervention Names:** - Behavioral: Music and Imagery **Label:** Music and Imagery **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Music and Imagery **Description:** See music and imagery arm description. **Name:** Music and Imagery **Other Names:** - MI; Supportive MI **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Percentage of contacted and eligible Veterans consent to study participation, attend intervention sessions, and complete the treatment protocol and scheduled outcome assessments **Measure:** Feasibility metrics **Time Frame:** 2 months **Description:** Veterans will be interviewed after completing study sessions to assess experiences of telehealth MI; aspects of the intervention, especially virtually delivery, that Veterans perceive to be most/least helpful or most/least liked; barriers and facilitators to study participation; how the music interventions compare to other migraine treatments already tried. **Measure:** Acceptability interviews **Time Frame:** 6 month #### Secondary Outcomes **Description:** Log of headache frequency and characteristics **Measure:** Headache Diary **Time Frame:** Baseline and 3 months **Description:** Log of music listening frequency **Measure:** Music Diary **Time Frame:** During active music intervention (months 1-2) **Description:** Depression, self-reported assessment **Measure:** Patient Health Questionnaire (PHQ-9) **Time Frame:** 3 month **Description:** 5 item self reported assessment for headache-related disability **Measure:** Migraine Disability Assessment **Time Frame:** baseline and 3 month **Description:** 12-item, self-report measure of health-related quality life **Measure:** Veterans RAND 12-item (VR-12) **Time Frame:** baseline and 3 month **Description:** 7-item, self-report measure of anxiety **Measure:** Generalized Anxiety Disorder Screener (GAD-7) **Time Frame:** baseline and 3 month **Description:** a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD **Measure:** Post-Traumatic Stress Disorder Checklist (PCL-5) **Time Frame:** baseline and 3 month **Description:** The HPCS is a 13-item self-report measure of catastrophic thinking related to headache **Measure:** Headache Pain Catastrophizing Scale (HPCS) **Time Frame:** baseline and 3 month **Description:** a 25-item self-report questionnaire related to a person's confidence in their ability to manage their headache symptoms **Measure:** Headache Management Self-Efficacy Scale (HMSE) **Time Frame:** baseline and 3 month **Description:** single item scale measures the participant's perception of improvement since the start of the study **Measure:** Patient Global Perception of Change (PGPC) **Time Frame:** 3 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * A migraine headache ICD-10 diagnosis, and confirmed by the American Migraine Prevalence and Prevention (AMPP) assessment. * Completion of at least 28 headache diary days * A confirmed frequency of ≥4 headache days per month * Confirmed access to a smartphone, computer/tablet * A primary pain complaint of headache. Patients must be stabilized on their headache medications. Patients must be on their current headache medications for the last 3 months and have no known future changes to those medications for the next 3 months from the start of enrollment. Exclusion Criteria: * Non-Veterans * Veterans without a migraine headache ICD-10 diagnosis * Veterans without a migraine headache confirmation from AMPP * Veterans whose primary pain complaint is not headache * Veterans who do not speak English * Veterans with a significant cognitive impairment based on EHR ICD10 diagnosis \[Mild Cognitive Impairment G31.84; Dementia F03.90; Alzheimer's Dementia G30.9\] and confirmed by the Short Portable Mental Status Questionnaire (SPMSQ)19 cognitive screener during the initial baseline assessment. Veterans with a hearing deficit that would impair participation in the MI intervention * Veterans who have a diagnosis of Traumatic Brain Injury ≤ 1 year before diagnosis of migraine or worsening of migraine as indicated by post-traumatic headache screening tool * Veterans currently suffering from a disabling psychiatric illness (as noted by clinician); or psychiatric hospitalization in the last 6 months * Veterans who have active psychotic symptoms, suicidality, or severe depressive symptoms (PHQ score \>20) per patient report and/or EHR notes * Veterans who have had suicidal and/or homicidal ideation in the past 6 months. * Veterans who decline to or cannot pass the tech screening4b * Veterans receiving hospice or palliative care * Veterans who do not have access to smartphone, computer/tablet **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Kristin M Story, PhD **Phone:** 317-554-0000 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000051270 - Term: Headache Disorders, Primary - ID: D000020773 - Term: Headache Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M11852 - Name: Migraine Disorders - Relevance: HIGH - As Found: Migraine - ID: M9351 - Name: Headache - Relevance: HIGH - As Found: Headache - ID: M22529 - Name: Headache Disorders - Relevance: LOW - As Found: Unknown - ID: M26657 - Name: Headache Disorders, Primary - 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: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008881 - Term: Migraine Disorders - ID: D000006261 - Term: Headache ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06440863 **Brief Title:** Postoperative BMI Changes and Functional Outcomes in Knee and Hip Arthroplasty **Official Title:** The Effect of Changes in Body Mass Index After Total Knee and Hip Arthroplasty on Patient Functional Scores #### Organization Study ID Info **ID:** Y7MQG7gO #### Organization **Class:** OTHER **Full Name:** Istanbul University - Cerrahpasa (IUC) ### Status Module #### Completion Date **Date:** 2024-05-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-01 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-12-30 **Type:** ACTUAL #### Start Date **Date:** 2018-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-06-01 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Istanbul University - Cerrahpasa (IUC) #### Responsible Party **Investigator Affiliation:** Istanbul University - Cerrahpasa (IUC) **Investigator Full Name:** Mete Ozer **Investigator Title:** Research Assistant **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** PURPOSE Obesity poses challenges to preoperative mobility and functional recovery for arthroplasty patients, yet postoperative weight loss remains elusive. This study aims to investigate postoperative weight changes and their impact on functional scores following knee and hip arthroplasty, exploring factors influencing these changes. METHODS A total of 459 knee and hip arthroplasty cases with a 2-year follow-up were analyzed. BMI and Oxford scores were tracked, alongside factors including comorbidities, corticosteroid use, physiotherapy, and unilateral vs. bilateral surgery. EXPECTED OUTCOMES Based on the study's design and the data available, we anticipate observing the impact of changes in patients' BMI on clinical scores as an independent variable. Additionally, we aim to elucidate the effects of comorbidities, corticosteroid use, physiatrist follow-up, and the type of surgical procedure on both BMI and clinical outcomes. Through this analysis, we expect to gain a comprehensive understanding of how these factors interplay to influence postoperative recovery and overall patient health. ### Conditions Module **Conditions:** - Arthropathy - Obesity **Keywords:** - Total Hip Arthroplasty - Total Knee Arthroplasty - Weight Loss - Obesity - Body Mass Index ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 459 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients indicated for total knee arthroplasty. **Intervention Names:** - Procedure: Total Knee Arthroplasty **Label:** Total Knee Arthroplasty **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Patients indicated for total hip arthroplasty. **Intervention Names:** - Procedure: Total Hip arthroplasty **Label:** Total Hip Arthroplasty **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Total Knee Arthroplasty **Description:** Patients undergoing total knee arthroplasty **Name:** Total Knee Arthroplasty **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Total Hip Arthroplasty **Description:** Patients undergoing total hip arthroplasty **Name:** Total Hip arthroplasty **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. **Measure:** BMI **Time Frame:** 2 years **Description:** It is scored between 0 and 48. 48 is the best function. **Measure:** Oxford hip and knee scores **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients who underwent primary TKA and THA with a 2-year follow-up were included Exclusion Criteria: * Patients who underwent bariatric surgery before or after the surgery * Incomplete 2-year follow-up * Whom BMI or Oxford scores could not be accessed **Maximum Age:** 80 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine **State:** Fatih **Zip:** 34098 #### Overall Officials **Official 1:** **Affiliation:** Istanbul University - Cerrahpasa (IUC) **Name:** Cumhur Deniz Davulcu **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Yes All demographic data, clinical scores, and BMI measurement results will be shared. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES ### References Module #### References **Citation:** Woodruff MJ, Stone MH. Comparison of weight changes after total hip or knee arthroplasty. J Arthroplasty. 2001 Jan;16(1):22-4. doi: 10.1054/arth.2001.9826. **PMID:** 11172266 **Citation:** Riddle DL, Singh JA, Harmsen WS, Schleck CD, Lewallen DG. Clinically important body weight gain following knee arthroplasty: a five-year comparative cohort study. Arthritis Care Res (Hoboken). 2013 May;65(5):669-77. doi: 10.1002/acr.21880. **PMID:** 23203539 **Citation:** Inacio MC, Silverstein DK, Raman R, Macera CA, Nichols JF, Shaffer RA, Fithian D. Weight patterns before and after total joint arthroplasty and characteristics associated with weight change. Perm J. 2014 Winter;18(1):25-31. doi: 10.7812/TPP/13-082. **PMID:** 24626069 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009140 - Term: Musculoskeletal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC05 - Name: Musculoskeletal Diseases ### Condition Browse Module - Browse Leaves - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: HIGH - As Found: Arthropathy - ID: M18102 - Name: Weight Loss - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007592 - Term: Joint Diseases ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06440850 **Brief Title:** Vemurafenib and Cobimetinib for the Treatment of Patients With High Risk Differentiated Thyroid Carcinoma With BRAFV600E Mutation **Official Title:** A Pilot Clinical Trial of Vemurafenib and Cobimetinib as a Redifferentiation Strategy in High-Risk, Radioactive Iodine (RAI) Naïve, BRAFV600E Mutated Differentiated Thyroid Carcinoma Patients Undergoing Initial RAI Therapy #### Organization Study ID Info **ID:** 21522 #### Organization **Class:** OTHER **Full Name:** City of Hope Medical Center #### Secondary ID Infos **Domain:** CTRP (Clinical Trial Reporting Program) **ID:** NCI-2024-02359 **Type:** REGISTRY **Domain:** City of Hope Medical Center **ID:** 21522 **Type:** OTHER **ID:** P30CA033572 **Link:** https://reporter.nih.gov/quickSearch/P30CA033572 **Type:** NIH ### Status Module #### Completion Date **Date:** 2026-11-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-01 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-11-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-11-30 **Type:** ESTIMATED **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-04-19 **Study First Submit QC Date:** 2024-06-01 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Cancer Institute (NCI) #### Lead Sponsor **Class:** OTHER **Name:** City of Hope Medical Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This phase II trial tests how well vemurafenib and cobimetinib work in treating patients with high risk differentiated thyroid carcinoma with BRAFV600E mutation, in preparation for radioactive iodine therapy. Vemurafenib and cobimetinib are used in patients whose cancer has a mutated (changed) form of a gene called BRAF. They are in a class of medications called kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving vemurafenib and cobimetinib may work better to treat patients with high risk differentiated thyroid carcinoma with BRAFV600E mutation, in preparation for radioactive iodine therapy. **Detailed Description:** PRIMARY OBJECTIVE: I. The proportion of BRAF mutated high-risk differentiated thyroid carcinoma patients who achieve excellent or indeterminate response with vemurafenib and cobimetinib treatment prior to initial radioactive iodine (RAI) therapy as defined by American Thyroid Association guideline. SECONDARY OBJECTIVES: I. The proportion of patients who had significant change on their I-123 scan before and after the targeted therapy. II. To evaluate the safety and tolerability as determined by adverse events related to vemurafenib and cobimetinib combination therapy. III. To evaluate the efficacy of vemurafenib and cobimetinib in enhancing RAI avidity by assessing the progression-free survival. IV. To evaluate the diagnostic and prognostic value of thyroglobulin level as determined by thyroglobulin changes associated with treatment response. V. To evaluate the tumor molecular characteristics in treatment responders as compared to non-responders. OUTLINE: Patients receive vemurafenib orally (PO) twice per day (BID) for 6 weeks and cobimetinib PO once per day (QD) for 3 weeks, followed by 1 week off, and then continuing for 2 weeks. Patients then receive iodine 131 PO followed by 3 additional days of vemurafenib PO BID and cobimetinib PO QD. Patients receive thyrogen intramuscularly (IM) daily for 2 days followed by I-123 diagnostic scan during screening and on study. Patients also undergo magnetic resonance imaging (MRI) during screening, positron emission tomography (PET) scan or computed tomography (CT) scan and blood sample collection throughout the study and ultrasound imaging and I-131 whole body scan during follow up. After completion of study treatment, patients are followed up every 3 months for up to 12 months. ### Conditions Module **Conditions:** - Thyroid Gland Follicular Carcinoma - Thyroid Gland Oncocytic Carcinoma - Thyroid Gland Papillary Carcinoma ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 21 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients receive vemurafenib PO BID for 6 weeks and cobimetinib PO QD for 3 weeks, followed by 1 week off, and then continuing for 2 weeks. Patients then receive iodine 131 PO followed by 3 additional days of vemurafenib PO BID and cobimetinib PO QD. Patients receive thyrogen IM daily for 2 days followed by I-123 diagnostic scan during screening and on study. Patients also undergo MRI during screening, PET scan or CT scan and blood sample collection throughout the study and ultrasound imaging and I-131 whole body scan during follow up. **Intervention Names:** - Procedure: Biospecimen Collection - Drug: Cobimetinib - Procedure: Computed Tomography - Procedure: Diagnostic Imaging - Procedure: I-131 Uptake Test - Radiation: Iodine I-131 - Procedure: Magnetic Resonance Imaging - Procedure: Positron Emission Tomography - Biological: Recombinant Thyrotropin Alfa - Procedure: Ultrasound Imaging - Drug: Vemurafenib **Label:** Treatment (vemurafenib and cobimetinib) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment (vemurafenib and cobimetinib) **Description:** Undergo blood sample collection **Name:** Biospecimen Collection **Other Names:** - Biological Sample Collection - Biospecimen Collected - Specimen Collection **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Treatment (vemurafenib and cobimetinib) **Description:** Given PO **Name:** Cobimetinib **Other Names:** - Cotellic - GDC-0973 - MEK Inhibitor GDC-0973 - XL518 **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Treatment (vemurafenib and cobimetinib) **Description:** Undergo CT scan **Name:** Computed Tomography **Other Names:** - CAT - CAT Scan - Computed Axial Tomography - Computerized Axial Tomography - Computerized axial tomography (procedure) - Computerized Tomography - Computerized Tomography (CT) scan - CT - CT Scan - tomography **Type:** PROCEDURE #### Intervention 4 **Arm Group Labels:** - Treatment (vemurafenib and cobimetinib) **Description:** Undergo I-123 diagnostic scan **Name:** Diagnostic Imaging **Other Names:** - Medical Imaging **Type:** PROCEDURE #### Intervention 5 **Arm Group Labels:** - Treatment (vemurafenib and cobimetinib) **Description:** Undergo I-131 whole body scan **Name:** I-131 Uptake Test **Other Names:** - I 131 Uptake - I-131 Uptake and Scan - Radioactive Iodine Uptake **Type:** PROCEDURE #### Intervention 6 **Arm Group Labels:** - Treatment (vemurafenib and cobimetinib) **Description:** Given PO **Name:** Iodine I-131 **Other Names:** - 131-Iodine - Bound Iodide I-131 - I 131 - I-131 - Iodide I-131 - Iodide, I-131 - Iodine 131 - Iodine-131 - Iodotope - Iodotrope **Type:** RADIATION #### Intervention 7 **Arm Group Labels:** - Treatment (vemurafenib and cobimetinib) **Description:** Undergo MRI **Name:** Magnetic Resonance Imaging **Other Names:** - Magnetic Resonance - Magnetic Resonance Imaging (MRI) - Magnetic resonance imaging (procedure) - Magnetic Resonance Imaging Scan - Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance - MR - MR Imaging - MRI - MRI Scan - MRIs - NMR Imaging - NMRI - Nuclear Magnetic Resonance Imaging - sMRI - Structural MRI **Type:** PROCEDURE #### Intervention 8 **Arm Group Labels:** - Treatment (vemurafenib and cobimetinib) **Description:** Undergo PET scan **Name:** Positron Emission Tomography **Other Names:** - Medical Imaging, Positron Emission Tomography - PET - PET Scan - Positron emission tomography (procedure) - Positron Emission Tomography Scan - Positron-Emission Tomography - proton magnetic resonance spectroscopic imaging - PT **Type:** PROCEDURE #### Intervention 9 **Arm Group Labels:** - Treatment (vemurafenib and cobimetinib) **Description:** Given IM **Name:** Recombinant Thyrotropin Alfa **Other Names:** - Recombinant Thyrotropin Alpha - Recombinant TSH Alpha - Thyrogen - Thyroid Stimulating Hormone Alpha - Thyrotropin Alfa - TSH-alpha **Type:** BIOLOGICAL #### Intervention 10 **Arm Group Labels:** - Treatment (vemurafenib and cobimetinib) **Description:** Undergo neck ultrasound **Name:** Ultrasound Imaging **Other Names:** - 2-Dimensional Grayscale Ultrasound Imaging - 2-Dimensional Ultrasound Imaging - 2D-US - Ultrasonography - Ultrasound - Ultrasound Test - Ultrasound, Medical - US **Type:** PROCEDURE #### Intervention 11 **Arm Group Labels:** - Treatment (vemurafenib and cobimetinib) **Description:** Given PO **Name:** Vemurafenib **Other Names:** - BRAF (V600E) kinase inhibitor RO5185426 - BRAF(V600E) Kinase Inhibitor RO5185426 - PLX-4032 - PLX4032 - RG 7204 - RG7204 - RO 5185426 - Zelboraf **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Excellent and indeterminate responses are defined by 2015 American Thyroid Association Management Guildelines for Differentiated Thyroid Cancer: * Excellent: Negative imaging and either suppresed thyroglobulin \< 0.2 ng/mL or TSH-stimulated thyroglobulin \< 1 ng/mL * Indeterminate: Nonspecific findings on imaging studies, faint uptake in thyroid bed on RAI scans, nonstimulated thyroglobulin detectable, but \<1 ng/mL, stimulated thyroglobulin detectable but \<10 ng/mL or thyroglobulin antibodies stable or declining in the absence of structural or functional disease **Measure:** Patients who achieve excellent or indeterminate response with vemurafenib and cobimetinib treatment prior to radioactive iodine therapy **Time Frame:** Up to completion of 6 week vemurafenib and cobimetinib therapy #### Secondary Outcomes **Measure:** Proportion of patients who achieve increased iodine incorporation to a predicted lesion absorbed dose of 2000 cGy with I-131 dose of ≤ 300 mCi **Time Frame:** Up to completion of 6 week vemurafenib and cobimetinib therapy **Description:** Will be summarized by type, severity (by Common Terminology Criteria for Adverse Events version 5.0 and nadir or maximum values for lab measures), date of onset, duration, reversibility, and attribution. **Measure:** Incidence of treatment related adverse events **Time Frame:** Up to completion of 6 week vemurafenib and cobimetinib therapy and 3 days of post-radioactive iodine therapy **Description:** From initiation of study therapy to the first observation of disease relapse/progression or death from any cause, whichever occurs first. **Measure:** Progression free survival **Time Frame:** Up to one year after treatment **Measure:** Changes in thyroglobulin levels **Time Frame:** Baseline, 3, 6, 9, months post-treatment up to one year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Willingness to be followed for about 14 months * Males or females aged ≥ 18 years at the time of informed consent * Patients with thyroid carcinoma of follicular origin (papillary, follicular or Hurthle cell) * Known positive BRAFV600E mutation (determined on a previous analysis and/or on a representative formalin-fixed paraffin embedded (FFPE) tumor samples or on a biopsy sample) * High risk for recurrence according to the American Thyroid Association (ATA) guideline defined as having one or more of the features below: * Gross extrathyroidal extension * FTC with extensive vascular invasion (\> 4), although less likely to have BRAF mutation * PTC with vascular invasion * Advanced nodal disease of (any node \>3 cm, \> 4 nodes, or extra-nodal extension) * BRAF+TERT promoter mutation * Post op thyroglobulin (TG) suggestive of distant metastasis * Distant metastatic sites (only for exploratory arm) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Blood pressure (BP) ≤ 140/90 mm Hg at screening with or without antihypertensive medications and no change in antihypertensive medications within 1 week prior to treatment start * Creatinine clearance ≥ 50 mL/min according to the Cockcroft and Gault formula * Absolute neutrophil count (ANC) ≥ 1.5 x 109/L * Hemoglobin ≥ 9.0 g/dL * Platelet count ≥ 100 x 109/L * Normal blood coagulation function as evidenced by an International Normalized Ratio (INR) ≤ 1.5 * Bilirubin ≤ 1.5 × upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert's syndrome * Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 3 × ULN (≤ 5 × ULN if subject has liver metastases) * Women of childbearing potential must have a negative urine or serum β-HCG pregnancy test within 7 days prior to the administration of the first study treatment * Agreement by women of childbearing potential (WOCBP) and males of childbearing potential\* to use an effective\*\* method of birth control\*\* for at least 3 months prior to screening through 1 year of study follow-up. * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only) * Effective birth control defined as hormonal and/or barrier contraception * Non-English speaking persons and adults lacking capacity to consent are not excluded from participation Exclusion Criteria: * Prior RAI treatment * Prior anti-BRAF, anti-MEK treatment such as sorafenib, dabrafenib, vemurafenib, encorafenib, binimetinib, cobimetinib, trametinib, d selumitinib and other TKIs like, lenvatinib, sunitinib, axitinib, cabozantenib, vandatinib, pazopanib use * Low to intermediate risk differentiated thyroid cancer (DTC) cases (not having the high-risk features as described above) * RAI contraindication * Undifferentiated or Medullary (MTC) carcinoma of the thyroid * Major surgery within 4 weeks prior to the first dose of treatment * Subjects having \> 1 + proteinuria on urine dipstick testing will undergo 24 h urine collection for quantitative assessment of proteinuria. Subjects with urine protein ≥ 1 g/24 h will be ineligible * Need for locoregional treatment such as surgery, external beam radiation or thermoablation at inclusion * External beam radiation, for thyroid cancer, \<4 weeks prior initiation of treatment * Gastrointestinal malabsorption or any other condition that in the opinion of the investigator might affect the absorption of the drugs * History of congestive heart failure greater or equal to than New York Heart association (NYHA) Class II, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of treatment, or cardiac arrhythmia associated with significant cardiovascular impairment and uncontrolled hypertension * Electrocardiogram (ECG) with QT interval (QTc) interval ≥ 480 msec * Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 2 months prior to the first dose of treatment and any other active bleeding, coagulopathy or pathologic condition that would confer a high risk of bleeding * Active infection requiring systemic therapy * Active malignancy (except for DTC, or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or bladder) within the past 24 months * Any history of or concomitant medical condition that, in the opinion of the investigator, would compromise subject's ability to safely complete the protocol * Females who are pregnant or breastfeeding * Patients with an injection of radio-contrast agent within 12 weeks prior to enrollment (can be enrolled after 12 weeks) * Previous history of retinal vein occlusion * Previous history of central serious retinopathy * Known hypersensitivity to the study drugs or to any of the excipients * Any other condition (including psychosocial condition) that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * Any other condition that would confound study results * Noncompliance * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics) **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Duarte **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Sasan Fazeli - **Phone:** 626-256-4673 - **Phone Ext:** 82251 - **Role:** CONTACT ***Contact 2:*** - **Name:** Sasan Fazeli - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** City of Hope Medical Center **State:** California **Status:** RECRUITING **Zip:** 91010 #### Overall Officials **Official 1:** **Affiliation:** City of Hope Medical Center **Name:** Sasan Fazeli **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000004700 - Term: Endocrine System Diseases - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000018307 - Term: Neoplasms, Squamous Cell - ID: D000000231 - Term: Adenocarcinoma, Papillary - ID: D000000230 - Term: Adenocarcinoma ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M16723 - Name: Thyroid Neoplasms - Relevance: HIGH - As Found: Thyroid Carcinoma - ID: M16718 - Name: Thyroid Diseases - Relevance: HIGH - As Found: Thyroid - ID: M5547 - Name: Carcinoma, Papillary - Relevance: HIGH - As Found: Papillary Carcinoma - ID: M1729 - Name: Thyroid Cancer, Papillary - Relevance: HIGH - As Found: Thyroid Gland Papillary Carcinoma - ID: M20409 - Name: Adenocarcinoma, Follicular - Relevance: HIGH - As Found: Thyroid Gland Follicular Carcinoma - ID: M3585 - Name: Adenocarcinoma - 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: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown - ID: M20451 - Name: Neoplasms, Squamous Cell - Relevance: LOW - As Found: Unknown - ID: M3586 - Name: Adenocarcinoma, Papillary - Relevance: LOW - As Found: Unknown - ID: T4401 - Name: Papillary Thyroid Carcinoma - Relevance: HIGH - As Found: Thyroid Gland Papillary Carcinoma ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000013964 - Term: Thyroid Neoplasms - ID: D000002291 - Term: Carcinoma, Papillary - ID: D000077273 - Term: Thyroid Cancer, Papillary - ID: D000018263 - Term: Adenocarcinoma, Follicular - ID: D000013959 - Term: Thyroid Diseases ### Intervention Browse Module - Ancestors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000891 - Term: Anti-Infective Agents, Local - ID: D000000890 - Term: Anti-Infective Agents - ID: D000014131 - Term: Trace Elements - ID: D000018977 - Term: Micronutrients - ID: D000000970 - Term: Antineoplastic Agents - ID: D000047428 - Term: Protein Kinase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents ### Intervention Browse Module - Browse Leaves - ID: M10488 - Name: Iodine - Relevance: HIGH - As Found: Needed - ID: M229695 - Name: Cadexomer iodine - Relevance: HIGH - As Found: Needed - ID: M1810 - Name: Vemurafenib - Relevance: HIGH - As Found: Eating habits - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M4215 - Name: Anti-Infective Agents, Local - Relevance: LOW - As Found: Unknown - ID: M21009 - Name: Micronutrients - Relevance: LOW - As Found: Unknown - ID: M16885 - Name: Trace Elements - Relevance: LOW - As Found: Unknown - ID: M25820 - Name: Protein Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000007455 - Term: Iodine - ID: C000038634 - Term: Cadexomer iodine - ID: D000077484 - Term: Vemurafenib ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06440837 **Acronym:** IMB **Brief Title:** Effectiveness of Stress Self-management Health Education Based on IMB Theory Among Nursing Students **Official Title:** Effectiveness of Stress Self-management Health Education Based on IMB Theory Among Nursing Students, Shanxi Province, China #### Organization Study ID Info **ID:** ChangzhiMC #### Organization **Class:** OTHER **Full Name:** Changzhi Medical College ### Status Module #### Completion Date **Date:** 2026-08-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-03 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-10-10 **Type:** ESTIMATED **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-28 **Study First Submit QC Date:** 2024-06-03 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Changzhi Medical College #### Responsible Party **Investigator Affiliation:** Changzhi Medical College **Investigator Full Name:** Dong Xiujuan **Investigator Title:** research leader **Type:** PRINCIPAL_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 cluster randomized controlled study is to test the effectiveness of IMB stress self-management health education on nursing students registered in first semester. The main question aims to answer are: Does IMB stress self-management health education program improving stress in nursing students? Researcher will compare wait-list group without any intervention to experimental group which received IMB stress self-management health education, to see if IMB stress self-management health education works to improving stress among nursing students. Participants will Attend IMB stress self-management health education program once a week for 8 weeks. In addition, complete questionnaires at pre-intervention, post-intervention, 1-month post-intervention, 3-months post-intervention, 6-months post-intervention. **Detailed Description:** This study intends to select first-year undergraduate nursing students registered in October 2024 at Changzhi Medical College in Shanxi as the sampling population. A total of 120 eligible individual samples in eligible clusters will be screened according to inclusion and exclusion criteria, and the cluster samples will be randomly assigned to either the wait-list group or the intervention group. Participants in wait-list group will not receive any intervention, while participants in intervention group will receive IMB-based stress self-management health education. The intervention will last for 8 weeks, with one module delivers by weeks. Each module will include a 30-40 minute lecture combined with exercises, discussions, and role-playing activities. Measurements will be taken before the intervention, immediately after the intervention, and at 1 month, 3 months, and 6 months post-intervention. These measurements will include the Stress Knowledge Questionnaire, the Multidimensional Scale of Perceived Social Support, the Self-Compassion Scale, the Resilience Scale, and the stress sub-scale of the Depression Anxiety Stress Scale. The study data will be analyzed using the intention-to-treat (ITT) method. Continuous data will be described using mean (standard deviation) or median (interquartile range), and categorical data will be described using frequency and percentage. Repeated measures ANOVA will be used to compare differences between the two groups before the intervention, immediately after the intervention, and at 1 month, 3 months, and 6 months post-intervention. Generalized linear models (GMM) will be utilized to determine the effects of IMB-based stress self-management health education on the variables immediately post-intervention, and at 1 month, 3 months, and 6 months post-intervention, while controlling for confounding variables. Sensitivity analysis will be performed and reported. The mean estimates will be set with a 95% confidence interval, and the significance level will be set at P \< 0.05. This study aims to explore new low-cost approaches for current college student mental health education, improve stress self-management abilities and stress levels among nursing students, prevent mental disorders, and promote mental health. To ensure the safety of participants throughout the study, the research team will strictly adhere to ethical standards and undergo review and supervision by the ethics committee. Informed consent will be obtained from participants, and their privacy and personal information will be kept confidential, not disclosed or misused. Regular safety monitoring and risk assessments will be conducted. The research protocol will be strictly followed, and psychological counseling services will be provided to participants. ### Conditions Module **Conditions:** - Psychological Stress - Nursing Students **Keywords:** - health education - IMB model - cluster-randomized controlled study ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The random sequence generation will be implemented at the cluster level rather than the individual level to prevent sample contamination. Dormitories meeting the eligibility criteria will be coded and randomly assigned to either the intervention group or the control group. The random assignment will be executed using computer-generated software on a research randomization website, with a 1:1 allocation ratio. ##### Masking Info **Masking:** DOUBLE **Masking Description:** To ensure allocation concealment, an external party using a "third-party" allocation approach will be employed. This involves using a research assistant to maintain allocation concealment. The list of eligible dormitories will be sent to a second research assistant, who will then carry out the sequence generation described above. Neither the researchers nor other research personnel will be aware of the specific dormitory group assignments. **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** participant in this group will not accept any psychological intervention content during experimental period. After the study, the intervention will be distributed for free. **Label:** wait-list **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Participants in this arm will receive an online "IMB stress self-management health education" program. The health education intervention program contains eight module topics. **Intervention Names:** - Behavioral: IMB stress self-management health education **Label:** IMB stress self-management health education **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - IMB stress self-management health education **Description:** The health education intervention program contains eight module topics: stress-related knowledge, the thinking and mentality under stress, social support, take care of your suffering, manage your difficult emotions, acceptance, embrace a better life, ending. One topic or session is delivered by weeks, each session lasting 30-40 minutes. **Name:** IMB stress self-management health education **Other Names:** - "information-motivation-behavioral skills" stress self-management health education **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The DASS-42 is a 42 item self-report scale is designed to measure the emotional states of depression, anxiety and stress. Each of the 42 questions in DASS is scored on a 4-point scale ranging from 0("Did not apply to me at all") to 3("Applied to me very much, or most of the time"). Scores for Stress is calculated by summing the scores for the 14 items: 1, 6, 8, 11, 12, 14, 18, 22, 27, 29, 32, 33, 35, 39. Total score of the stress subscale ranged from 0 to 42, the level of stress can be categorized five level based on total score actually measured: normal (score from 0 to 14), mild (score from 15 to 18), moderate (score from 19 to 25), Sever (score from 26 to 33), extreme sever (score from 34 above), therefore, higher score indicate higher level of stress. **Measure:** stress sub-scale of DASS-21 **Time Frame:** baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention. #### Secondary Outcomes **Description:** Stress Knowledge Questionnaire (SKQ) is used to assess people's knowledge of stress. The questionnaire is consisting of 7 questions using true/false options as answer. **Measure:** Stress Knowledge Questionnaire **Time Frame:** baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention. **Description:** Stress Mindset Measure- General is a self-reported instrument used to measure individual's belief toward stress. It is an 8-item tool to address the extent to which an individual adopts a mindset that the effects of stress are enhancing or debilitating. Each item rated in form of 5-Likert scale, ranging from 0=strongly disagree to 4=strongly agree. The item 1, 3, 5, 7 is negative items while the item 2, 4, 6, 8 is positive item. The total score is obtained by reverse scoring the four negative items and then taking the mean of all 8 items. Higher scores represent the mindset that stress is enhancing. **Measure:** Stress Mindset Measure-General **Time Frame:** baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention. **Description:** Multidimensional Scale of Perceived Social Support (MSPSS) is a self-report measure of social support scale that emphasizes individual subjective understanding and feelings. The questionnaire is a 12-item scale which designed to assess three perceived sources of supports: family (Items 3, 4, 8, and 11), friends (Items 6, 7, 9, and 12) and significant others (Items 1, 2, 5, and 10). Each item is scored from 1 (extremely disagree) to 7 (extremely agree). Three level of support can be categorized by the mean scale score. The mean scale score ranged from 1 to 2.9 could be considered low support; a score of 3 to 5 could be considered moderate support; a score from 5.1 to 7 could be considered high support. **Measure:** Multidimensional Scale of Perceived Social Support **Time Frame:** baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention. **Description:** The Chinese version of Self-Compassion Scale consists 12 items on five-point Likert scale (0= 'almost never' to 5= 'almost always') to record how often you behave kindly and caring toward yourself in difficult situations. It could be used to test three dimensions of self-compassion: Common Humanity, Mindfulness, and Self-Kindly. Item 2, 4, 5, 8, 11 are reverse scored item. The total score of the instrument ranged from 12 to 60, higher score indicates higher self-compassion, vice versa. The Chinese version SCS-SF exhibit high reliability and validity. **Measure:** Self-Compassion Scale Short Form **Time Frame:** baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention. **Description:** The 10-item psychological resilience scale is used to measure the ability to cope with illness, stress, failure, etc. The scale is a 5-point Likert (0= 'almost never' to 4= 'almost most') self-reported questionnaire; The total score of the scale is the sum of the response of each item, ranged from 0 to 40; Higher total score indicates higher resilience capacity. **Measure:** Connor-Davidson Resilience Scale **Time Frame:** baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. cluster * dormitories located in Changzhi Medical College * The residents in the dormitory are all nursing students that registered in fist-semester 2. individual * Registered in undergraduate nursing program * Registered in the first-semester study * Have a mobile device that can access internet * Voluntarily participated in this study Exclusion Criteria: 1. cluster * The residents in the dormitory are mixed with students from other majors except nursing. * The residents in the dormitory are mixed with nursing students from other grade. 2. individual * Diagnosed with mental problems or severe physical problems, e.g., depression, generalized anxiety disorder, or diabetes * Previous participation in other stress intervention studies **Healthy Volunteers:** True **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Dong Xiujuan, Master **Phone:** +8618334526688 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** University Putra Malaysia **Name:** binti Ahmad Norliza, Dr **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u. **PMID:** 7726811 **Citation:** Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113. **PMID:** 12964174 **Citation:** Crum AJ, Salovey P, Achor S. Rethinking stress: the role of mindsets in determining the stress response. J Pers Soc Psychol. 2013 Apr;104(4):716-33. doi: 10.1037/a0031201. Epub 2013 Feb 25. **PMID:** 23437923 **Citation:** Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the Multidimensional Scale of Perceived Social Support. J Pers Assess. 1990 Winter;55(3-4):610-7. doi: 10.1080/00223891.1990.9674095. **PMID:** 2280326 ## Derived Section ### Condition Browse Module - Ancestors - 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: M16105 - Name: Stress, Psychological - Relevance: HIGH - As Found: Psychological Stress - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013315 - Term: Stress, Psychological ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06440824 **Brief Title:** A Multicenter Randomized Controlled Study on the Treatment of Refractory CTIT With Romiplostim N01 Compared to Recombinant Human Thrombopoietin **Official Title:** A Multicenter Randomized Controlled Study on the Treatment of Refractory CTIT With Romiplostim N01 Compared to Recombinant Human Thrombopoietin #### Organization Study ID Info **ID:** QLMA-CIT-IIT-001 #### Organization **Class:** OTHER **Full Name:** Shandong University ### Status Module #### Completion Date **Date:** 2025-11-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-03 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-06-03 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Shandong University #### Responsible Party **Investigator Affiliation:** Shandong University **Investigator Full Name:** Ming Hou **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** A Multicenter Randomized Controlled Study on the Treatment of Refractory CTIT With Romiplostim N01 Compared to Recombinant Human Thrombopoietin ### Conditions Module **Conditions:** - CTIT-Chemotherapy Induced Thrombocytopenia **Keywords:** - Romiplostim N01，Recombinant Human Thrombopoietin，CTIT ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Romiplostim N01 **Label:** Romiplostim N01 **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Recombinant Human Thrombopoietin **Label:** Recombinant Human Thrombopoietin **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Romiplostim N01 **Description:** 2.0 µg/kg, subcutaneous injection, once a week, up to a maximum of 8 weeks. Stop medication when platelet count increases by 50 × 109/L or more compared to before medication **Name:** Romiplostim N01 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Recombinant Human Thrombopoietin **Description:** 30000 U/d, subcutaneously injected once a day, for a maximum of 8 weeks. Medication should be stopped when platelets increase by 50 × 109/L or more compared to before medication **Name:** Recombinant Human Thrombopoietin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** The proportion of patients with PLT ≥ 50 × 109/L within 4 weeks after receiving treatment **Time Frame:** Within 4 weeks after receiving treatment #### Secondary Outcomes **Measure:** The time required for PLT to recover to 50 × 109/L or above after treatment **Time Frame:** up to 8 weeks **Measure:** The proportion of patients with PLT ≥ 50 × 109/L after 2 weeks of treatment **Time Frame:** 2 weeks after receiving treatment **Measure:** The proportion of patients with PLT ≥ 50 × 109/L after 12 weeks of treatment **Time Frame:** 12 weeks after receiving treatment **Measure:** The lowest platelet count from receiving treatment to the end of treatment **Time Frame:** up to 8 weeks **Measure:** The proportion of patients receiving platelet transfusion **Time Frame:** through study completion, an average of 5 months **Measure:** The proportion of restoring anti-tumor treatment for at least 2 cycles without recurrence of CTIT **Time Frame:** through study completion, an average of 5 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Sign a written informed consent form before enrollment; 2. Age range from 18 to 75 years old; 3. Solid tumors or hematological tumors confirmed by tissue or pathology; 4. CTIT patients caused by anti-tumor therapy; 5. At least 2 weeks of treatment with two types of platelet growth factors and no response (including rhTPO or TPO-RA) 6. Have not received treatment with Roptistine/Roptistine N01; 7. ECOG PS score: 0-2; 8. Platelet value\<30 × 109/L; 9. Estimated survival time during screening is ≥ 12 weeks; 10. Subjects of childbearing age agree to take reliable contraceptive measures (including male or female condoms, contraceptive foam, contraceptive gel, contraceptive film, contraceptive cream, contraceptive suppository, abstinence and the placement of intrauterine devices, etc.) throughout the study period; Excluding female participants who have undergone hysterectomy, bilateral salpingectomy, bilateral tubal ligation, or more than 1 year after menopause, as well as male participants who have undergone bilateral salpingectomy or ligation; 11. Voluntarily participate in this study, sign an informed consent form, and have good compliance. Exclusion Criteria: - Patients with any of the following conditions are not eligible for inclusion in this study: 1. Suffering from hematopoietic system diseases other than thrombocytopenia (CIT) caused by tumor chemotherapy drugs, including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome; 2. Screening for thrombocytopenia caused by causes other than CIT within the first 6 months, including but not limited to chronic liver disease, splenic hyperfunction, infection, and bleeding; 3. Bone marrow invasion or metastasis; 4. Have received pelvic and spinal radiation therapy, as well as bone field radiation therapy, or are currently/expected to receive radiation therapy within the three months prior to screening; 5. Screening for a history of severe cardiovascular disease within the first 6 months, such as congestive heart failure (NYHA heart function score III-IV), known arrhythmias that increase the risk of thromboembolism, such as atrial fibrillation, after coronary stent implantation, angioplasty, and coronary artery bypass grafting; 6. Any history of arterial or venous thrombosis occurring within the first 6 months of screening; 7. Screening for clinical manifestations of severe bleeding within the first two weeks, such as gastrointestinal or central nervous system bleeding; 8. Brain tumors or brain metastases; 9. Urgent treatment is required, such as vena cava syndrome and spinal cord compression syndrome; 10. Neutrophil absolute value \< 1.0 × 109/L, hemoglobin \< 80g/L, allowing the use of granulocyte colony-stimulating factors and red blood cells that comply with clinical norms EPO infusion therapy; 11. Significant abnormalities in liver function: patients without liver metastasis, ALT/AST\>3ULN (upper limit of normal value), TBIL\>3ULN； Patients with liver metastasis are present, ALT/AST≥5ULN，TBIL≥5ULN； 12. Renal dysfunction: blood creatinine ≥ 1.5ULN or eGFR ≤ 60 ml/min (Cockcroft Gault formula); 13. Within the first month prior to screening, patients who have received treatment with loperstine/loperstine N01 or recombinant human thrombopoietin (rhTPO); 14. Received platelet transfusion within the first 3 days of randomization; 15. Patients who are known or expected to be allergic or intolerant to Roxetine N01 or rhTPO excipients 16. HIV infected individuals; 17. Pregnant or lactating women; 18. Participated in any clinical study of any other investigational drug or device three months prior to screening; 19. The researchers believe that participating in the trial poses a significant risk to the health or safety of the subjects, or other circumstances that may affect the efficacy evaluation. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001791 - Term: Blood Platelet Disorders - ID: D000006402 - Term: Hematologic Diseases - ID: D000095542 - Term: Cytopenia ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M16680 - Name: Thrombocytopenia - Relevance: HIGH - As Found: Thrombocytopenia - ID: M5072 - Name: Blood Platelet Disorders - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M3170 - Name: Cytopenia - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013921 - Term: Thrombocytopenia ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06440811 **Brief Title:** Preoperative Adjuvant SOX Plus PL-1 Antibody and FLOT Plus PD-1 Antibody for Locally Advanced dMMR Gastric Cancer **Official Title:** Safety and Efficacy of Preoperative Adjuvant SOX Regimen Combined With PD-1 Antibody Versus FLOT Regimen With PD-1 Antibody for the Treatment of Localized Deficient Mismatch Repair Gastric Cancer: a Chinese Trial #### Organization Study ID Info **ID:** loong-101 #### Organization **Class:** OTHER **Full Name:** Xijing Hospital ### Status Module #### Completion Date **Date:** 2025-03-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-03 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-01-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-01 **Type:** ACTUAL **Status Verified Date:** 2023-12 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-04-06 **Study First Submit QC Date:** 2024-06-03 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Xijing Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of the study is to learn about Safety and efficacy of preoperative adjuvant SOX regimen combined with PD-1 antibody versus FLOT Regimen with PD-1 antibody in localized deficient mismatch repair gastric cancer. The main question it aims to answer are: * Safety and efficacy of preoperative adjuvant SOX regimen combined with PD-1 antibody versus FLOT regimen with PD-1 antibody for the treatment of localized deficient mismatch repair gastric cancer * Disease-free survival of preoperative adjuvant SOX plus PD-1 antibody and FLOT plus PD-1 antibody for dMMR and locally advanced gastric cancer. Participants will be divided into two groups to use a FLOT chemotherapy regimen plus PD-1 antibody and a SOX chemotherapy regimen plus PD-1 antibody. Researchers would compare tumor regression grade, adverse effects and survival benefit of two preoperative adjuvant regimens. ### Conditions Module **Conditions:** - Gastric Cancer - Immune-related Adverse Event - Chemotherapeutic Toxicity **Keywords:** - neoadjuvant chemotherapy - Nivolumab - SOX - FLOT - deficient Mismatch Repair - locally advanced ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients in the FLOT group received 4 cycles of standard FLOT chemotherapy, the FLOT chemotherapy cycle consists of: day 1: intravenous 5-FU 2600 mg/m² inserted through a peripherally inserted central catheter (PICC) for 24 hours intravenous folic acid 200 mg/m2 intravenous OXA 85 mg/m² intravenous TXT 50 mg/m². The next cycle of chemotherapy was repeated on day 15. PD-1 antibody: 360 mg every 3 weeks. **Intervention Names:** - Drug: FLOT+PD-1 antibody **Label:** FLOT+PD-1 antibody **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Patients in the SOX group received 3 cycles of S-1 + OXA chemotherapy prior to radical gastrectomy.The SOX chemotherapy cycle consists of: day 1: intravenous OXA 130 mg/m² days 1-14: oral S-1 80 mg/m², 2 times/Day. Repeat next chemotherapy on day 22. PD-1 antibody: 360 mg every 3 weeks. **Intervention Names:** - Drug: SOX+PD-1 antibody **Label:** SOX+PD-1 antibody **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - SOX+PD-1 antibody **Description:** Patients would be allocated to the SOX+PD-1 antibody group. **Name:** SOX+PD-1 antibody **Other Names:** - SOX+Nivolumab **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - FLOT+PD-1 antibody **Description:** Patients would be allocated to the FLOT+PD-1 antibody group **Name:** FLOT+PD-1 antibody **Other Names:** - FLOT+Nivolumab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** adverse event caused by FLOT, SOX or PD-1 antibody treatment, which were coded using the Medical Dictionary Regulatory Activities version 20.1 and adverse event grade according to the National Cancer Institute Common Terminology Criteria for Adverse Events **Measure:** adverse event **Time Frame:** From the preoperative chemotherapy until the occurrence of adverse events, assessed up to 180 days #### Secondary Outcomes **Description:** Residual tumor components in post-radiotherapy samples and the proportion of fibrosis **Measure:** tumor regression grade **Time Frame:** From the surgery to evaluation of tumor regression grade, assessed up to 1 week **Description:** from diagnosis to recurrence or death **Measure:** disease-free survival **Time Frame:** From date of diagnosis until the first documented recurrence or death, assessed up to 120 months **Description:** objective response rate defined as the proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST). **Measure:** objective response rate **Time Frame:** From the surgery to evaluation of objective response rate, assessed up to 1 week **Description:** Duration of response **Measure:** Duration of response **Time Frame:** From the first assessment of the tumor as CR or PR to the first assessment of PD (Progressive Disease) or death from any cause, assessed up to 120 months. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 1. Age \>=18 years and \<100 years. * 2. Diagnosed with locally advanced gastric cancer. * 3. Eastern Cooperative Oncology Group ECOG PS score 0-1. * 4. adoption of preoperative chemotherapy treatment and PD-1 antibody therapy. * 5. deficient mismatch repair identified by pathological detection. Exclusion Criteria: * 1. Locally advanced unable to resect or metastatic tumors. * 2. Patients with recurrence of residual gastric cancer * 3. Patients refusing surgical resection after preoperative chemotherapy therapy. * 4. Have received any anti-tumor therapy such as chemotherapy, radiotherapy, immunotherapy, etc., or have been more than 180 days since the last treatment. * 5. Patients with confirmed allergy to the study drug and/or its excipients. * 6. Severe malnutrition and active autoimmune diseases. * 7. Pregnant or lactating women. * 8. Patients with medical systemic diseases and psychiatric diseases that are not amenable to chemotherapy. * 9. Patients with acute infections requiring antibiotic treatment. * 10. Patients with acute infections requiring antibiotic treatment. * 11. Patients who are concomitantly receiving other immunotherapy, corticosteroids, and other anticancer therapies during the trial. * 12. Positive test result for hepatitis B or hepatitis C virus. * 13. Untreated central nervous system metastatic peripheral neuropathy (\>grade 1). * 14. History of malignancy within the past 5 years (with the exception of curative, localized cancer). * 15. Patients who are not expected to achieve R0 resection. * 16. Weight loss greater than or equal to 20% within 4 weeks before the first dose. * 17. Patients with multiple factors affecting oral medication. * 18. Vaccination within 4 weeks prior to the first dose of study drug. * 19. Patients who have received immune checkpoint inhibitors and develop serious adverse reactions after treatment and need to be permanently disabled. * 20. The investigator believes that the subject has other serious systemic diseases or other reasons and is not suitable for this clinical study. **Maximum Age:** 100 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jipeng Li, Doctor **Phone:** 13991316190 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Jun Zhu, Doctor **Phone:** 1509033172 **Role:** CONTACT #### Locations **Location 1:** **City:** Xi'an **Country:** China **Facility:** Tangdu hospital **State:** Shaanxi **Status:** ACTIVE_NOT_RECRUITING **Zip:** 710032 **Location 2:** **City:** Xi'an **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jiawei Song, Doctor - **Phone:** 15281929912 - **Role:** CONTACT **Country:** China **Facility:** Shaanxi Provincial People's Hospital **State:** Shaanxi **Status:** RECRUITING **Location 3:** **City:** Xi'an **Contacts:** ***Contact 1:*** - **Name:** Jipeng Li - **Phone:** +86-029-84771533 - **Role:** CONTACT **Country:** China **Facility:** Xijing hospital **State:** Shaanxi **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Xijing Hospital **Name:** Jipeng Li, Doctor **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000013272 - Term: Stomach Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16064 - Name: Stomach Neoplasms - Relevance: HIGH - As Found: Gastric Cancer - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M16062 - Name: Stomach Diseases - Relevance: LOW - As Found: Unknown - ID: T5486 - Name: Stomach Cancer - Relevance: HIGH - As Found: Gastric Cancer ### Condition Browse Module - Meshes - ID: D000013274 - Term: Stomach Neoplasms ### Intervention Browse Module - Ancestors - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - 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: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: Hemat - Name: Hematinics - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M17546 - Name: Vitamin B Complex - Relevance: LOW - As Found: Unknown - ID: M8600 - Name: Fluorouracil - Relevance: LOW - As Found: Unknown - ID: M4225 - Name: Antibodies - Relevance: HIGH - As Found: Given - ID: M1854 - Name: Nivolumab - Relevance: HIGH - As Found: Prospective - ID: M10184 - Name: Immunoglobulins - Relevance: HIGH - As Found: Given - ID: M8618 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: M19117 - Name: Immunoglobulins, Intravenous - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: LOW - As Found: Unknown - ID: T447 - Name: Folinic Acid - Relevance: LOW - As Found: Unknown - ID: T446 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: T448 - Name: Folate - Relevance: LOW - As Found: Unknown - ID: T475 - Name: Vitamin B9 - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077594 - Term: Nivolumab - ID: D000000906 - Term: Antibodies - ID: D000007136 - Term: Immunoglobulins ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06440798 **Brief Title:** Mental Health Content and Mental Health Outcomes **Official Title:** Examining the Effects of Mental Health Content on Help-Seeking and Self-Diagnosing Behavior: Cross-sectional Survey Study #### Organization Study ID Info **ID:** NUS-IRB-2023-864 #### Organization **Class:** OTHER **Full Name:** Yale-NUS College ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-03 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-06-03 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Yale-NUS College #### 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 will aim to explore the relationship between mental health content on social media and health behavior, addressing a gap in empirical research. Using the Theory of Planned Behavior, a survey with over 600 participants will examine associations between exposure to mental health content and behaviors like help-seeking and self-diagnosis. **Detailed Description:** Background: Mental health content has recently surged in popularity across social media. However, current empirical research lacks a comprehensive understanding of the relationship between mental health content and health behaviour. Objective: This study will aim to address this gap by examining different types of mental health content and their relationship to behavior. Specifically, it will explore whether exposure to mental health content will be associated with either positive behaviors, like help-seeking, or maladaptive ones, such as self-diagnosing. Methods: Utilizing the Theory of Planned Behavior, a cross-sectional epidemiological survey will be conducted with over 600 participants to answer the research questions. Baseline measures will include participants' exposure to various types of mental health content, and mental well-being (depression, anxiety, and scores from the DASS-21). The outcome measures of interest will be help-seeking attitude (IASMHS) and self-diagnosing (SELF-I) behavior. ### Conditions Module **Conditions:** - Help-Seeking Behavior - Psych - Depression - Anxiety - Stress **Keywords:** - Mental Health Content ### Design Module #### Design Info **Observational Model:** ECOLOGIC_OR_COMMUNITY **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 600 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Inventory of Attitudes toward Seeking Mental Health Services (IASMHS). Items were on a 5-point Likert scale ranging from 0 ("Somewhat Disagree") to 4 ("Agree"). **Measure:** Help-Seeking Behaviors **Time Frame:** Through study completion, an average of 1 year **Description:** Self-identification as having a Mental Illness (SELF-I) scale. Items were on 5-point Likert scale ranging from 1 (Not true at all) to 5 (Completely True) **Measure:** Self-Diagnosing Behaviors for Mental Health **Time Frame:** Through study completion, an average of 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Enrollment is restricted to healthy adults between 21-34 (or 18-34 for university students) * Use at least one social media platform (e.g., Facebook, Instagram, LinkedIn, X) * Participants need to be able to read and understand English. * Participants must also have lived in Singapore for at least 2 years. Exclusion Criteria: * Anyone who does not feel comfortable answering questions related to mental health and exposure to mental health-related content online. **Healthy Volunteers:** True **Maximum Age:** 34 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** Recruiting a representative sample of around 600 people through the National University of Singapore (NUS) and the general public in Singapore through physical posters or online platforms (e.g., the university's Work Scheme website, and research groups on Telegram). ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Sundarimaa Erdembileg **Phone:** +65 6601 1000 **Role:** CONTACT #### Locations **Location 1:** **City:** Singapore **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jean Liu, PhD - **Phone:** +65 6601-3694 - **Role:** CONTACT **Country:** Singapore **Facility:** Yale-NUS **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Yale-NUS College **Name:** Sundarimaa Erdembileg **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Given the sensitivity of mental health disclosures and the age of the population, no individual participant data will be shared as agreed upon with the IRB. Results will be published by the investigators in academic journals. Sharing of generated study data can be made available upon request by writing to the investigator(s). **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare 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: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003863 - Term: Depression ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06440785 **Brief Title:** Taylor Swift and Mental Health Outcomes **Official Title:** The Relation Between Following Taylor Swift on Social Media, Connecting With Her Music and Mental Health Outcomes in Youths: Cross-sectional Survey Study #### Organization Study ID Info **ID:** NUS-IRB-2023-864B #### Organization **Class:** OTHER **Full Name:** Yale-NUS College ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-03 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-06-03 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Yale-NUS College #### 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 in Singapore will explore the potential of pop culture, particularly Taylor Swift's music, in influencing young adults' attitudes toward mental health. With the highest prevalence of mental illness among this age group, the study will aim to investigate whether engagement with Swift's songs and social media will be associated with attitudes crucial for help-seeking, such as recognizing mental health issues and being open to professional services. Conducting a survey of over 600 young adults, the researchers will assess participants' mental health symptoms, engagement with Swift's content, social media and demographics, mental health help-seeking attitude and mental health self-diagnosing behavior. **Detailed Description:** Background: Epidemiological surveys suggest that young adulthood is the age group with the highest prevalence of mental illness. However, many young adults have negative views towards help-seeking and do not access professional services. To address this gap, popular culture may provide population-level levers to improve mental health outcomes. Objective: In this study, we will focus on Taylor Swift - a singer whose songs explore themes related to mental health. As the first objective, we will seek to understand whether young adults will feel a personal connection to her mental health-themed songs and follow her on social media. We will then examine whether these forms of engagement will predict attitudes critical for help-seeking: namely, acknowledgement that one may have a mental illness, and willingness to seek professional services as needed. Methods: In the months leading up to Taylor Swift's concerts, we will conduct a survey of over 600 young adults in Singapore (aged 18 to 34). As the primary outcome measures, participants will complete the Self-Identification as Having Mental Illness Scale (SELFI) and the Inventory of Attitudes toward Seeking Mental Health Services scale (IASMHS). As predictor variables, participants will answer questions related to: (i) their baseline symptoms of depression, anxiety, and stress; (ii) their engagement with Taylor Swift's songs and social media content; and (iii) their demographics. ### Conditions Module **Conditions:** - Social Stigma - Psych - Depression, Anxiety - Stress **Keywords:** - Pop-Culture - Music - Mental Health literacy - Adolescent Health ### Design Module #### Design Info **Observational Model:** ECOLOGIC_OR_COMMUNITY **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 600 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Inventory of Attitudes toward Seeking Mental Health Services (IASMHS). Items were on a 5-point Likert scale ranging from 0 ("Somewhat Disagree") to 4 ("Agree"). **Measure:** Help-Seeking Behaviors **Time Frame:** Through study completion, an average of 1 year **Description:** Self-identification as having a Mental Illness (SELF-I) scale. Items were on 5-point Likert scale ranging from 1 (Not true at all) to 5 (Completely True) **Measure:** Self-Diagnosing Behaviors for Mental Health **Time Frame:** Through study completion, an average of 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Enrollment is restricted to healthy adults between 18-34 * Use at least one of the following social media platforms: Facebook, Instagram, LinkedIn, X (Twitter), TikTok * Have lived in Singapore for at least 2 years. * Participants need to be able to read and understand English. Exclusion Criteria: * Anyone who does not feel comfortable answering questions related to mental health and exposure to mental health-related content online. **Healthy Volunteers:** True **Maximum Age:** 34 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** Recruiting a representative sample of around 600 people through the National University of Singapore (NUS) and the general public in Singapore through physical posters or online platforms (e.g., the university's Work Scheme website, and research groups on Telegram). ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Sundarimaa Erdembileg **Phone:** +65 6601-1000 **Role:** CONTACT #### Locations **Location 1:** **City:** Singapore **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jean Liu, PhD - **Phone:** +65 6601-3694 - **Role:** CONTACT **Country:** Singapore **Facility:** Yale-NUS **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Yale-NUS College **Name:** Sundarimaa Erdembileg **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Given the sensitivity of mental health disclosures and the age of the population, no individual participant data will be shared as agreed upon with the IRB. Results will be published by the investigators in academic journals. Sharing of generated study data can be made available upon request by writing to the investigator(s). **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare 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: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003863 - Term: Depression ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06440772 **Brief Title:** Portal Vein Pulsatility Index to Assess Fluid Intolerance **Official Title:** Assessing Fluid Intolerance Using Portal Vein Pulsatility Index Post-Passive Leg Raising Test in Fluid Responders: A Prospective Cohort Study #### Organization Study ID Info **ID:** 9593/04.04.2024 #### Organization **Class:** OTHER **Full Name:** Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu ### Status Module #### Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-01 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-07-01 **Type:** ACTUAL **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-30 **Study First Submit QC Date:** 2024-06-01 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu #### Responsible Party **Investigator Affiliation:** Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu **Investigator Full Name:** Balan Ion Cosmin **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:** This study uses the portal vein pulsatility index (PVPI) to assess fluid intolerance amongst fluid responders. **Detailed Description:** This prospective observational study aims to use the portal vein pulsatility index (PVPI) to assess fluid intolerance in fluid responders. The investigators will enroll mechanically ventilated postoperative adult patients within 6 hours of ICU admission after cardiac surgery. Patients will undergo a Passive Leg Raising (PLR) test and Left Ventricular Outflow Tract (LVOT) recording using transthoracic echocardiography. The main objective is to predict fluid intolerance after a fluid challenge of 7 ml/kg Ringer Lactate over 10 minutes in initially tolerant fluid responders. ### Conditions Module **Conditions:** - Venous Congestion **Keywords:** - congestion - portal vein pulsatility - ultrasound - fluid responsiveness - fluid tolerance ### 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:** Patients who are both responsive and tolerant to fluid. **Intervention Names:** - Drug: Ringer's Lactate Crystalloid Solutions **Label:** Tolerant Fluid Responders ### Interventions #### Intervention 1 **Arm Group Labels:** - Tolerant Fluid Responders **Description:** 7 ml/kg ml of Ringer's Lactate is given in 10 min amongst initially tolerant fluid responders. **Name:** Ringer's Lactate Crystalloid Solutions **Other Names:** - Fluid challenge **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** A portal vein pulsatility index greater than 50%, calculated as (Vmax - Vmin) / Vmax, with no upper limit and 0% as the minimum limit. Higher values indicate worse outcomes. Ultrasonographic portal spectral waveform was used to measure Vmax and Vmin. **Measure:** Fluid Intolerance **Time Frame:** 10 minutes after 7 ml/kg Ringer's Lactate ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Informed consent. * Mechanically ventilated patients within 6 hours after ICU admission following surgery who are considered for fluid administration to optimize haemodynamics. * Sinus rhythm. Exclusion Criteria: * A condition known to interfere with portal vein flow assessment or interpretation (liver cirrhosis or chronic hepatic disease, suprahepatic or portal vein thrombosis). * Any mechanical circulatory support. * Cardiac transplant. * Poor transthoracic echocardiographic window. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Mechanically ventilated postoperative adult patients after cardiac surgery within 6 hours after intensive care unit admission. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Cosmin Balan, PhD **Phone:** +40722751501 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Bianca Morosanu **Phone:** +40734619519 **Role:** CONTACT #### Locations **Location 1:** **City:** Bucharest **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Cosmin Balan, PhD - **Phone:** +40722751501 - **Role:** CONTACT **Country:** Romania **Facility:** "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases **Status:** RECRUITING **Zip:** 022328 #### Overall Officials **Official 1:** **Affiliation:** "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases **Name:** Cosmin Balan, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases **Name:** Serban-Ion Bubenek-Turconi, Professor **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M9991 - Name: Hyperemia - Relevance: HIGH - As Found: Venous Congestion - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006940 - Term: Hyperemia ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06440759 **Brief Title:** To Compare the Efficacy and Safety of Using oXiris and M100 During CRRT **Official Title:** Evaluation of Efficacy and Safety Using oXiris Versus M100 Filter in Pneumonia-induced Acute Kidney Injury (AKI) Patients Requiring Continuous Renal Replacement Therapy (CRRT) #### Organization Study ID Info **ID:** USM/JEPeM/KK/23090718 #### Organization **Class:** OTHER **Full Name:** Universiti Sains Malaysia ### Status Module #### Completion Date **Date:** 2025-10-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-04-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-04-30 **Study First Submit QC Date:** 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mohd Zulfakar Mazlan, MBBS #### Responsible Party **Investigator Affiliation:** Universiti Sains Malaysia **Investigator Full Name:** Mohd Zulfakar Mazlan, MBBS **Investigator Title:** Associate Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study aimed to compare the efficacy of Oxiris (Baxter) and M100 filters on IL-6 as primary outcomes and other blood cell counts, blood biochemistry (serum urea, creatinine, potassium, sodium), inflammation indicators (CRP, PCT), as secondary outcomes and safety (28 days mortality as a primary outcome and coagulopathy, lifespan of filter, usage of vasopressor, clinical conditions (ventilator-free days, ICU and hospital- length of stay) as a secondary outcome), clinical conditions (ventilator-free days, ICU and hospital- length of stay), and mortality of patients with pneumonia-related AKI. **Detailed Description:** The type of hemofilter will be decided using a simple randomization. For the intervention group, only the oxiris filter will be used during the treatment period, while for the control group, the M100 filter will be used throughout the treatment. If the filter becomes clogged within 24 hours, the investigator will replace it with the same filter as the previous one. However, if the filter becomes clogged after 24 hours and the patient still requires CRRT, the investigator will replace it with M100. This change in filter type will not affect the study results, as only the blood parameters during the first 24 hours of treatment will be evaluated for objective one. The oxiris filter will be used for the first 24 hours, or whichever is longer, and will be replaced with an M100 filter if indicated for both groups. Therefore, it will not affect the outcome of objective two compared to the standard arm group Termination of CRRT will be done according to recent studies once the patient fulfills either one or more of these criteria: urine output and serum creatinine are indicative of kidney recovery, vasopressor cessation, increased urine output ≥500ml/24H without diuretics, correction of fluid overload, hemodynamic stability and the possible need to shift to intermittent dialysis. The patient will be followed up until 28 days following ICU admission. To avoid any missing data, at least 3 contact numbers will be made available. If unable to get in contact with the patient, the application status of alive or dead will be applied to a national registry. ### Conditions Module **Conditions:** - AKI - Acute Kidney Injury - Pneumonia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Masking Description:** single-blinding (patient) **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Continuous Renal Replacement Therapy with the adsorption membrane filter Oxiris. The specific septic biomarkers such as interleukin 6(IL-6), procalcitonin (PCT), C-reactive protein (CRP) along with other routine blood investigation results taken at the beginning of therapy and 24 hours after the treatment will be compared. The 28-day mortality will be recorded following treatment. **Intervention Names:** - Device: oXiris filter **Label:** oXiris filter **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Continuous Renal Replacement Therapy with the adsorption membrane filter M100. The specific septic biomarkers such as interleukin 6(IL-6), procalcitonin (PCT), C-reactive protein (CRP) along with other routine blood investigation results taken at the beginning of therapy and 24 hours after the treatment will be compared. The 28-day mortality will be recorded following treatment. **Intervention Names:** - Device: M100 filter **Label:** M100 filter **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - oXiris filter **Description:** Continuous Renal Replacement Therapy with the adsorption membrane filter Oxiris. The specific septic biomarkers such as interleukin 6(IL-6), procalcitonin (PCT), C-reactive protein (CRP) along with other routine blood investigation results taken at the beginning of therapy and 24 hours after the treatment will be compared. **Name:** oXiris filter **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - M100 filter **Description:** Continuous Renal Replacement Therapy with the adsorption membrane filter M100. The specific septic biomarkers such as interleukin 6(IL-6), procalcitonin (PCT), C-reactive protein (CRP) along with other routine blood investigation results taken at the beginning of therapy and 24 hours after the treatment will be compared. **Name:** M100 filter **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** To measure the effectiveness of oxiris filter compared to the M100 filter in reducing the septic biomarker levels during CRRT. The baseline IL6 will be measured immediately before CRRT and post-CRRT **Measure:** To measure the effectiveness of the oxiris filter in reducing septic biomarker levels IL-6 **Time Frame:** 24 hours **Description:** To measure the 28-day mortality rate when using oxiris and M100 filter for CRRT. The 28-day mortality rate is calculated based on the number of deaths occurring within 28 days from a defined starting point, the start of CRRT. **Measure:** To compare the 28-days mortality of using oxiris filter during CRRT **Time Frame:** 28 days #### Secondary Outcomes **Description:** To measure the risk of infection rate when using oxiris filter for CRRT. An infection is defined as an infection of the CRRT catheter such as CRBSI. **Measure:** To compare the risk infection of by using oxiris during CRRT **Time Frame:** 28 days **Description:** To measure the risk of bleeding rate when using oxiris filter for CRRT. Bleeding is defined as any bleeding noted such as gastrointestinal, urinary bleeding or respiratory tract bleeding. **Measure:** To compare the risk bleeding of using oxiris during CRRT **Time Frame:** 28 days **Description:** To measure the risk of ventilator-free day rate when using oxiris filter for CRRT. It is defined as the number of days within a specific period (usually 28 days) during which a patient is both alive and free from mechanical ventilation. For example, if a patient is on mechanical ventilation for 10 days and survives the entire 28-day period, they would have 18 ventilator-free days (28 - 10 = 18). If a patient dies at any point within the 28 days, their VFDs would be zero. **Measure:** To compare the risk of ventilator-free days of using oxiris during CRRT **Time Frame:** 28 days **Description:** To measure the effectiveness of oxiris filter compared to the M100 filter in reducing the septic biomarker levels during CRRT. The baseline PCT will be measured immediately before CRRT and post-CRRT **Measure:** To measure the effectiveness of the oxiris filter in reducing septic biomarker levels PCT **Time Frame:** 24 hours **Description:** To measure the effectiveness of oxiris filter compared to the M100 filter in reducing the septic biomarker levels during CRRT. The baseline CRP will be measured immediately before CRRT and Post CRRT **Measure:** To measure the effectiveness of the oxiris filter in reducing septic biomarker levels CRP **Time Frame:** 24 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All adult patients aged\>18 years old * Diagnosis of septic shock * Diagnosis of KDIGO stage 3 acute renal failure Exclusion Criteria: * Moribund patient or patient that is expected to die within 72 hours * Pregnancy * patient with a bleeding tendency or known allergy to heparin **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Marina Azidah Mat Zaid, MBBS **Phone:** 0199870715 **Role:** CONTACT #### Locations **Location 1:** **City:** Kubang Kerian **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Mohd Zulfakar Mazlan, MBBS - **Phone:** +6097673000 - **Phone Ext:** 6104 - **Role:** CONTACT **Country:** Malaysia **Facility:** Hospital Universiti Sains Malaysia (HUSM) **State:** Kelantan **Status:** RECRUITING **Zip:** 16150 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000051437 - Term: Renal Insufficiency - ID: D000007674 - Term: Kidney Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M28998 - Name: Acute Kidney Injury - Relevance: HIGH - As Found: Acute Kidney Injury - ID: M13904 - Name: Pneumonia - Relevance: HIGH - As Found: Pneumonia - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M26718 - Name: Renal Insufficiency - Relevance: LOW - As Found: Unknown - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: 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: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011014 - Term: Pneumonia - ID: D000058186 - Term: Acute Kidney Injury ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06440746 **Brief Title:** Efficacy and Safety of Olokizumab in Patients With Progressive Fibrosing Interstitial Lung Diseases **Official Title:** A Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Phase 2/3 Study of Efficacy and Safety of Olokizumab in Subjects With Progressive Fibrosing Interstitial Lung Diseases #### Organization Study ID Info **ID:** CL04041109 #### Organization **Class:** INDUSTRY **Full Name:** R-Pharm ### Status Module #### Completion Date **Date:** 2026-12-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-06-20 **Type:** ESTIMATED #### Start Date **Date:** 2023-08-23 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-28 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** R-Pharm **Class:** UNKNOWN **Name:** Exacte Labs LLC **Class:** INDUSTRY **Name:** Data Management 365 **Class:** UNKNOWN **Name:** Keystat, LLC #### Lead Sponsor **Class:** INDUSTRY **Name:** R-Pharm International, LLC #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to evaluate efficacy and safety of olokizumab (OKZ) compared to placebo in patients progressive fibrosing Interstitial lung diseases (ILD). **Detailed Description:** This is a phase 2/3 study with double-blind parallel-group adaptive design. The study will include the following periods: 1. Screening period (4 weeks) Screening period (before the first administration of the test drug). Before being included in the study, patients will be provided with complete information about this clinical trial and signs the Informed consent Form (IF). After that the researcher will decide whether or not the patient can be randomized into the study. 2. Double-blind Treatment period (48 weeks). Following the completion of a Treatment period, all patients will be enrolled in Follow-up Period (FU). 3. Follow-up Period (24 weeks). During the FU Period, patients will visit study sites after 4,12 and 24 weeks after the end of the Treatment Period to complete FU-1 (Week 52), FU-2 (Week 60) and FU-3 (Week 72) visits. The overall study duration for the patients will be approximately 76 weeks (including the 4 weeks screening period) The analysis will be conducted in two sequential steps: * the interim analysis after 60 percent (%) of patients have completed the Treatment period (not including the FU period) * the final analysis when all patients have completed all periods (the Treatment and the FU periods). ### Conditions Module **Conditions:** - Lung Diseases, Interstitial **Keywords:** - Progressive Fibrosing Interstitial Lung Diseases - Olokizumab - Forced vital capacity ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 116 **Type:** ESTIMATED **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** SC injections of OKZ 64 mg q4w **Intervention Names:** - Drug: Subcutaneous (SC) injections of OKZ 64 milligrams (mg) every 4 weeks (q4w), one injection of 0.4 millilitre (mL) **Label:** Arm1:OKZ 64 mg q4w **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** SC injections of Placebo q4w **Intervention Names:** - Drug: SC injections of Placebo every 4 weeks (q4w), one injection of 0.4 mL **Label:** Arm2:Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Arm1:OKZ 64 mg q4w **Description:** Olokizumab is a sterile solution for subcutaneous injection in a 2-mL clear Type I glass vial, containing a target fill volume of 0.5 mL (for withdrawal of no less than 0.4 mL) of olokizumab drug substance at a concentration of 160 milligrams (mg)/mL. **Name:** Subcutaneous (SC) injections of OKZ 64 milligrams (mg) every 4 weeks (q4w), one injection of 0.4 millilitre (mL) **Other Names:** - Artlegia **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Arm2:Placebo **Description:** Placebo (sodium chloride 0.9 %) does not contain any active pharmaceutical ingredients. Placebo will be supplied in 2-mL, 5-mL, or 10-mL ampoules made of low-density polyethylene or polypropylene. **Name:** SC injections of Placebo every 4 weeks (q4w), one injection of 0.4 mL **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** FVC decline rate assessed over 48 weeks of therapy. FVC is the maximum amount of air that can be exhaled when blowing out as fast as possible. **Measure:** The rate of forced vital capacity (FVC) **Time Frame:** 48 weeks #### Secondary Outcomes **Description:** Absolute change in FVC from baseline at treatment weeks 24 and 48. **Measure:** Change in FVC from baseline **Time Frame:** 24, 48 weeks. **Description:** Change in FVC% predicted from baseline at treatment weeks 24 and 48. **Measure:** Change in FVC.% predicted **Time Frame:** 24,48 weeks **Description:** Number of patients (in %) with a decrease in FVC of ≥10 % predicted.at treatment week 48. **Measure:** Number of patients (in %) with a decrease in FVC **Time Frame:** 48 weeks **Description:** Number of patients (in %) with improved pulmonary function (change from baseline in FVC \>0% predicted. **Measure:** Number of patients (in %) with improved pulmonary function **Time Frame:** 48 weeks **Description:** Change in absolute values of DLCO from baseline at treatment weeks 24 and 48. **Measure:** Change of Diffusing capacity of the lungs for carbon monoxide (DLCO) **Time Frame:** 24,48 weeks **Description:** Change in the values of quantitative assessment of lung fibrosis from baseline based on high-resolution computed tomography (HRCT) data at treatment week 48. **Measure:** Change in the values of quantitative assessment of lung fibrosis from baseline **Time Frame:** 48 weeks **Description:** Proportion of patients with progression or death: the first event defined as death. Progression is a decrease in FVC ≥10% predicted, or decrease in DLCO ≥15% predicted from their baseline values. **Measure:** Proportion of patients with progression or death **Time Frame:** 48 weeks **Description:** Time to progression or death assessed over 48 weeks of treatment. **Measure:** Time to progression or death assessed over 48 weeks of treatment **Time Frame:** 48 weeks **Description:** An exacerbation of idiopathic lung fibrosis and other ILDs is defined as worsening shortness of breath over the past 30 days combined with evidence of new bilateral lesions appearing as ground-glass opacities and/or consolidations on a chest HRCT scan without other alternative causes (infections and other). **Measure:** Time to exacerbation over 48 weeks of treatment **Time Frame:** 48 weeks **Description:** Proportion of patients with exacerbation over 48 weeks of treatment. **Measure:** Proportion of patients with exacerbation at treatment weeks 24 and 48 **Time Frame:** 24,48 weeks **Description:** FACIT-Dyspnea questionnaire includes Dyspnea subscale, that measures the severity of dyspnea when doing everyday activities, and Functional Limitations subscale that measures the amount of difficulty experienced while doing these activities due to dyspnea in the past 7 days. Both subscales contain 10 items scored from 0 (best) to 4 (worst). A raw score (normal-worst range 0-30) is calculated as: Sum individual item scores \* 10 / number of items answered. Raw scores are then converted to scale scores using the table included in the FACIT Dyspnoea Scale Short Form Scoring Guideline. Scale score range: Dyspnea subscale from 27.7 (normal condition) to 75.9 (severe symptoms); Functional Limitations subscale from 29.7 (not limited) to 76.7 (severely limited) **Measure:** Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea scores from baseline at treatment weeks 24 and 48 **Time Frame:** 24,48 weeks **Description:** 36-Item Short-Form Health Survey (SF-36) is a patient reported survey of health consisting of 36 items that taps eight health concepts (domains): vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. It also includes a single item that provides an indication of perceived change in health. For each domain a scaled score is calculated as the weighted sum of the questions in this section. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. **Measure:** Change in Short Form-36 (SF-36) scores from baseline at treatment weeks 24 and 48 **Time Frame:** 24,48 weeks **Description:** Modified Medical Research Council (mMRC) Dyspnea Scale is used to assess perceived degree of baseline functional disability due to dyspnea. Participants indicate a score on 5-point scale according to the severity of their symptoms: none = 0; mild = 1; moderate = 2; severe =3; very severe = 4 **Measure:** Change in Modified Medical Research Council ( mMRC) dyspnea score from baseline at treatment weeks 24 and 48 **Time Frame:** 24,48 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. The patient has signed the Informed Consent Form 2. Progressive fibrosing ILD confirmed by high-resolution computed tomography (HRCT) documented evidence of \>10% lung tissue affected at Screening: A. Patients with an usual interstitial pneumonia (UIP) -like radiological pattern described in the 2022 American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines for the management Idiopathic pulmonary fibrosis (IPF) that do not have an identified primary condition В. Patients with progressive interstitial pneumonia with autoimmune features (IPAF) as defined in the American Thoracic Society/European Respiratory Society Statement, 2015 С. Patients with progressive lung fibrosis associated with different disorders (c) such as systemic connective tissue diseases, chronic fibrosin hypersensitivity pneumonitis (HP), idiopathic non-specific interstitial pneumonia (iNSIP) or sarcoidosis. Disease progression will be established based on a combination of criterion (I)(a) and criterion (II) or criterion (III)(b) I. Clinically significant decrease in FVC% predicted defined as absolute decrease of ≥ 5% within 12 months prior to screening or an absolute decrease DLCO (corrected for hemoglobin) of ≥10% predicted within 12 months prior to screening. II. Worsening respiratory symptoms without an alternative explanation within 12 months prior to screening. III. Increased area affected with fibrosis on chest HRCT (b) (according to the 2022 American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines) within 24 months prior to screening. 1. To assess this criterion (I), patient's pulmonary function test (PFT) results obtained within 12 months prior to screening must available. If data from multiple PFTs are available, the earliest results must be used for assessment. 2. Patients' results of at least one chest HRCT investigation performed no earlier than 24 months before randomization must be available for review. If results of multiple HRCT examinations are available, patient eligibility must be based on the earliest results. 3. stable course of the main disease not requiring a change in maintenance treatment. 3. ILD duration of no more than 5 years from the onset of respiratory symptoms by the date screening begins. 4. Elevated acute phase reactants at screening not related to other causes: C-reactive protein level ≥6 mg/l or Erythrocyte Sedimentation Rate (ESR) ≥28 millimeters per hour (mm/hour). 5. FVC ≥ 45% and ≤ 80% predicted at screening. Exclusion Criteria: 1. Hemoglobin-corrected DLCO \< 40% predicted at screening. 2. Significant airway obstruction at screening defined as a Forced expiratory volume in 1 second (FEV1) / FVC ratio of \<70 %. 3. Use of interleukin-6(IL-6 )inhibitors or IL-6 receptor inhibitors except for CoronaVirus Disease2019 (COVID-19) treatment. If those medications are used to treat COVID-19, the last administration of IL-6 inhibitors or IL-6 receptor inhibitors must have occurred at least 6 months prior to screening. 4. Administration of rituximab within less than 12 months prior to screening. 5. Treatment with systemic glucocorticosteroids (GCS) at \>10 mg/day calculated for prednisolone; or a change in the dose of GCS within 4 weeks before/during the screening period; or planned dose changes during the trial. 6. A history of bone marrow transplantation, total lymphoid tissue irradiation, or administration of ablative ultra-high doses of cyclophosphamide. 7. Initiation of mycophenolate mofetil or antifibrotic agents (for patients receiving mycophenolate mofetil and/or antifibrotics at study entry) less than 12 months prior to screening. 8. Discontinuation of previously prescribed antifibrotic agents within 6 months prior to screening (for patients not receiving antifibrotic drugs at study entry). 9. Participation in any other clinical trial less than 30 days prior to the baseline assessment or less than 5 half-lives of the medication examined in another clinical trial, whichever is longer. 10. Laboratory abnormalities as follows: * Alanine Aminotransferase (ALT) or Aspartate Aminotransferase(AST) ≥ 1.5×Upper Limit Normal (ULN) * Platelet count \<100×10\^9/litre (l) (\<100000/cubic millimetre (mm\^3) * Leukocyte count \<3.5×10\^9/l * Absolute neutrophil count \<2000×10\^6/l (\<2000/mm\^3). 11. Concurrent malignancy or a history of malignancy within the last 5 years. 12. Any acute infection at screening or exacerbation of a chronic infection, any infection requiring oral antibiotics or antivirals within 4 weeks prior to screening, injection of antimicrobial agents within 6 weeks before randomization, severe or recurrent infections requiring hospital admission within 6 months before randomization. 13. Patients with evidence of disseminated herpes zoster infection, herpes zoster with encephalitis, meningitis, or other forms of herpes zoster infection that do not resolve without treatment and occurred within 6 months prior to screening. 14. Evidence of any other chronic infection (including sepsis, invasive fungal infection, histoplasmosis, osteomyelitis) which, in the opinion of the Investigator, may increase the risk of infectious complications during the trial. 15. Patients with diverticulitis or other symptomatic gastrointestinal diseases that may lead to perforation, including such history (for example, diverticulitis, gastrointestinal perforation, ulcerative colitis). 16. Women of child-bearing potential or men whose partners are women of child-bearing potential who do not want to use highly effective methods of contraception during the trial and for at least 3 months after the last administration of the investigational product. 17. Known hypersensitivity to OKZ or any other component of the product or placebo. 18. History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies. 19. Other protocol-defined exclusion criteria apply. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yana Deloveri **Phone:** + 7 (968) 585-13-49 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Maria Lemak **Phone:** +7 (903) 709-20-43 **Role:** CONTACT #### Locations **Location 1:** **City:** Chelyabinsk **Country:** Russian Federation **Facility:** Regional Clinic Hospital№3 **Status:** RECRUITING **Zip:** 454001 **Location 2:** **City:** Chelyabinsk **Country:** Russian Federation **Facility:** Chelyabinsk Regional Clinical Hospital **Status:** RECRUITING **Zip:** 454048 **Location 3:** **City:** Izhevsk **Country:** Russian Federation **Facility:** LLC" Medsi-Izhevsk" **Status:** RECRUITING **Zip:** 426011, **Location 4:** **City:** Kemerovo **Country:** Russian Federation **Facility:** Kuzbass Clinical Hospital Emergency Medical Care named after Podgorbunsky M.A **Status:** RECRUITING **Zip:** 650000 **Location 5:** **City:** Moscow **Country:** Russian Federation **Facility:** City Clinical Hospital named after Pletnev D.D. **Status:** RECRUITING **Zip:** 105077 **Location 6:** **City:** Moscow **Country:** Russian Federation **Facility:** City Clinical Hospital named after Davydovsky I.V. **Status:** RECRUITING **Zip:** 109240 **Location 7:** **City:** Moscow **Country:** Russian Federation **Facility:** Scientific Research Institute of Reumatology named after Nasonova V.A **Status:** RECRUITING **Zip:** 115522 **Location 8:** **City:** Moscow **Country:** Russian Federation **Facility:** Moscow City Clinic №52 **Status:** RECRUITING **Zip:** 117546 **Location 9:** **City:** Moscow **Country:** Russian Federation **Facility:** Clinical Hospital №4 of Sechenov University **Status:** RECRUITING **Zip:** 119048 **Location 10:** **City:** Moscow **Country:** Russian Federation **Facility:** Clinical Hospital №3 of Sechenov University **Status:** RECRUITING **Zip:** 119435 **Location 11:** **City:** Moscow **Country:** Russian Federation **Facility:** City Clinical hospital №52 **Status:** RECRUITING **Zip:** 123182 **Location 12:** **City:** Moscow **Country:** Russian Federation **Facility:** FSBEI HE "Russian University of Medicine", MoH of Russia **Status:** RECRUITING **Zip:** 127473 **Location 13:** **City:** Moscow **Country:** Russian Federation **Facility:** Moscow Regional Research and Clinical Institute "MONIKI" **Status:** RECRUITING **Zip:** 129110 **Location 14:** **City:** Novosibirsk **Country:** Russian Federation **Facility:** Federal Research Center Institute of Cytologyand Genetics,Siberian Branch of Russian Academy of Sciences **Status:** RECRUITING **Zip:** 630117 **Location 15:** **City:** Petrozavodsk **Country:** Russian Federation **Facility:** Republican Hospital named after V.A. Baranov **Status:** RECRUITING **Zip:** 185019 **Location 16:** **City:** Saint Petersburg **Country:** Russian Federation **Facility:** Saint-Petersburg State Research Institute of Phthisiopulmonology of the Ministry of Healthcare of the Russian Federation **Status:** RECRUITING **Zip:** 139036 **Location 17:** **City:** Saint Petersburg **Country:** Russian Federation **Facility:** LLC"My Medical Center" **Status:** RECRUITING **Zip:** 191186 **Location 18:** **City:** Saint Petersburg **Country:** Russian Federation **Facility:** LLC"Energy of Health" **Status:** RECRUITING **Zip:** 194156 **Location 19:** **City:** Saint Petersburg **Country:** Russian Federation **Facility:** Medical Center "Interleukin" **Status:** RECRUITING **Zip:** 194214 **Location 20:** **City:** Saint Petersburg **Country:** Russian Federation **Facility:** City Multidisciplinary Hospital №2-Expert Center in the field of Pulmonology **Status:** RECRUITING **Zip:** 194354 **Location 21:** **City:** Saint Petersburg **Country:** Russian Federation **Facility:** LLC"Kurator" **Status:** RECRUITING **Zip:** 196240, **Location 22:** **City:** Saint Petersburg **Country:** Russian Federation **Facility:** Pavlov First Saint Petersburg State Medical University(Pavlov University) **Status:** RECRUITING **Zip:** 197022 **Location 23:** **City:** Yaroslavl **Country:** Russian Federation **Facility:** Clinical Hospital of Emergency Medical Care named after Solovyov N.V **Status:** RECRUITING **Zip:** 150003 #### Overall Officials **Official 1:** **Affiliation:** R-Pharm **Name:** Mikhail Samsonov **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M11168 - Name: Lung Diseases - Relevance: HIGH - As Found: Lung Disease - ID: M19813 - Name: Lung Diseases, Interstitial - Relevance: HIGH - As Found: Lung Diseases, Interstitial - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008171 - Term: Lung Diseases - ID: D000017563 - Term: Lung Diseases, Interstitial ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06440733 **Acronym:** GERYPHYSIO **Brief Title:** Effectiveness of 8 Week Multicomponent Exercise Program in Older Adults With Frailty and Cognitive Impairment **Official Title:** Effectiveness of 8 Week Multicomponent Exercise Program on the General Health and Balance of a Group of Older Adults With Frailty and Cognitive Impairment: a Quasi-experimental Pilot Study #### Organization Study ID Info **ID:** UMalagaGER #### Organization **Class:** OTHER **Full Name:** University of Malaga ### Status Module #### Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-08-19 **Type:** ESTIMATED #### Start Date **Date:** 2023-09-30 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Malaga #### Responsible Party **Investigator Affiliation:** University of Malaga **Investigator Full Name:** Rocío Martín Valero **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Multicomponent exercise program in a frail population. It is analyzed whether there is an improvement in different parameters of the daily life of the study subjects, analyzing the variables of: physical condition, fragility, balance, quality of life, upper limb strength, autonomy, cognitive state and depression. **Detailed Description:** In this study, an 8-week multicomponent exercise program will be carried out focused on improving the general physical condition and balance of older adult subjects, in order to try to reduce the risk of falls and improve the quality of life of a group. of older adults made up of 17 participants. During these 8 weeks, this intervention program will be carried out at least 3 times a week, for 50-55 minutes, which will consist of 4 typical sessions, based mainly on 5 large groups: weights, magic rings, elastic bands, ballasts and pikes... Each of these sessions will be carried out taking into account the main physiotherapy objectives, such as gaining strength in both upper and lower limbs, as well as proprioception, balance, and promoting a pleasant and safe social environment where these older people feel valid, capable of carrying out the program and everything is provided to them in a friendly and fun way, and always taking into account as far as possible , the individual characteristics of each study participant. All sessions will begin with a 5-minute aerobic exercise and end with a stretching program for another 5 minutes, to ensure you return to calm, along with breathing exercises. The intervention will begin by carrying out an initial evaluation already developed previously, and after this, standard sessions will begin, in which they will all begin and end in the same way. It will begin with a general warm-up based on general joint mobility of the head and neck, shoulders, trunk, elbows, hands, wrists, hips, knees and ankles to begin to accustom the body to the physical work environment. And at the end of the sessions, a stretching program will be carried out, and it will end with a return to calm with a respiratory training program, in which you will be instructed to take in air through the nose and release it through the mouth, while the room is silent, and thus promote self-awareness. ### Conditions Module **Conditions:** - Old Age; Debility **Keywords:** - Multicomponent exercise program - Fragility - Elderly - Balance - Quality of life - Autonomy - Functionality ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 17 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In this study, an 8-week multicomponent exercise program will be carried out focused on improving the general physical condition and balance of older adult subjects, in order to try to reduce the risk of falls and improve the quality of life of a group. of older adults made up of 17 participants. **Intervention Names:** - Other: Multicomponent exercise program focused in elderly. **Label:** Older adults with frailty and cognitive impairment **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Older adults with frailty and cognitive impairment **Description:** Each of these sessions will be carried out taking into account the main physiotherapy objectives, such as gaining strength in both upper and lower limbs, as well as proprioception, balance, and promoting a pleasant and safe social environment where these older people feel valid. All sessions will begin with a 5-minutes. It will begin with a general warm-up based on general joint mobility of the head and neck, shoulders, trunk, elbows, hands, wrists, hips, knees and ankles to begin to accustom the body to the physical work environment. And at the end of the sessions, a stretching program will be carried out, and it will end with a return to calm with a respiratory training program, in which you will be instructed to take in air through the nose and release it through the mouth, while the room is silent, and thus promote self-awareness. **Name:** Multicomponent exercise program focused in elderly. **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Analyze if there are changes in general physical condition and frailty after an 8 week multicomponent exercise program in a group of older adults before and after carrying it out using the Short Physical Performance Battery questionnaire. The score obtained with this geriatric evaluation test ranges between 0 and 12 points, and can be interpreted depending on the result obtained as: severe limitation or disabled between 0-3, moderate limitation or fragile/vulnerable between 4-6, limitation mild or pre-frail between 7-9, minimal limitation or autonomous/healthy between 10-12. However, if the participant obtains a score of less than 10 on the SPPB, it can be used as a mortality assessment criterion in studies that need to quantify the health benefits and improvements of specific treatments or rehabilitation programs, such as case of this present study. **Measure:** Short Physical Performance Battery **Time Frame:** Baseline up to 8 weeks. **Description:** Analyze the risks of falling before performing the multicomponent exercise program and after it, seeing if there is variation in it in the group of older adults using the Tinetti scale for balance and gait. The maximum score achievable with this scale is 28 points and 16 of them coming from the balance sphere, and 12 points coming from the gait sphere. So: High risk of falling: score less than 19 points, Average risk of falling: 19 to 23 points, and Low risk of falling: 24 to 28 points. **Measure:** Tinetti scale **Time Frame:** Baseline up to 8 weeks #### Secondary Outcomes **Description:** Check the influence of the multicomponent exercise program on the quality of life of the group of older adults using the Short-Form questionnaire . In this study, a variant of the questionnaire will be used in which Z scores are provided, that is, scores that compare with the average of the population, in this case comparing with the American population, being in both cases an average of 50. Everything that is close to 50 will be considered standard quality of life, everything that is above 50 will be considered good quality of life and everything that is below 50 will be considered bad quality of life. **Measure:** Short Form 12 Questionnaire **Time Frame:** Baseline, up to 8 weeks. **Description:** Analyze changes in the muscle strength of the upper limbs of a group of older adults before and after the multicomponent exercise program using a Jamar hand-held dynamometer. To analyze the muscular strength of the upper limbs of the study subjects, a Jamar dynamometer requested as study material from the University of Malaga will be used, and it will be carried out in a specific pattern. The patient will be placed in a sitting position, with a 90º flexion of the elbow and with the hand making a grip on the handle of the device. **Measure:** Strength in hands. **Time Frame:** Baseline, up to 8 weeks. **Description:** Prove the changes in the autonomy of a group of older adults before and after a multicomponent exercise program thanks to the Barthel index for basic activities of daily living. The Barthel index contains 10 items, including bathing, toileting, dressing, feeding, bladder control, toileting, chair or bed transfers, stair climbing, and ambulation. Its items are scored based on the degree of dependence that the patient presents, with a score that can range from 0 to 100, with 0 being a maximum level of dependence and 100 being a maximum level of independence according to the scale. **Measure:** Barthel Index **Time Frame:** Baseline, up to 8 weeks. **Description:** Check the changes at a cognitive, emotional and social level before and after the multicomponent exercise program using Yesavage Geriatric Depression Scale. This scale is scored from 0 to 15, with a score less than 5 being the range of normality, between 5-9 being the range of mild depression, and a score higher than 10 being indicative of moderate to severe depression, being questions with a dichotomous response to items 1, 5, 7, 11, and 13 are considered indicative of depression. **Measure:** Yesavage depression scale **Time Frame:** Baseline, up to 8 weeks. **Description:** Analyze changes at a cognitive, emotional and social level before and after the multicomponent exercise program using Lobo Mini Cognitive Examination. The Lobo Mini Cognitive Examination (MEC) is a test that analyzes the cognitive deterioration of patients, coming from the adaptation of the original test "Mini-Mental State Examination" (MMSE) created by Folstein , performed by Lobo in 1979 .The initial test Mini-Mental State Examination consists of 30 points, unlike the Mini Cognitive Examination, which presents up to a score of 35, analyzing 6 cognitive abilities, plus five more questions on attention, calculation and language, also presenting a completion time of between 10 and 15 minutes. Cognitive impairment is considered to exist when the score is less than 23 points. **Measure:** Lobo Mini Cognitive Examination **Time Frame:** Baseline, up to 8 weeks. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults over 65 years of age. * People with frailty according to the Short Physical Performance Battery, * who have the ability to walk (autonomous or with external aids), * and who obtain a score greater than or equal to 15 in the Lobo Mini Cognitive Examination (MEC-35 of Lobo). * patients with a resolved hip fracture, with Parkinson's, * Patients who are committed and motivated to carry out the study, as well as patients who agree to sign the informed consent and the report sheet prior to carrying out the study. Exclusion Criteria: * Old Adults under 65 years of age. * Patients who do not present frailty or the ability to walk (autonomous or with external aids). * People who obtain a score of less than 15 in the Lobo Mini Cognitive Exam therefore presenting a serious deterioration of the emotional and cognitive state. * Older adults who are under treatment with tranquilizers or sedatives, non-diuretic hypotensive agents or antidepressants. * Patients with amyotrophic lateral sclerosis, multiple sclerosis, diabetic neuropathy, severe sensory deficit, and study subjects without motivation or interest in participating in the study. * Older adults who do not agree to sign the study, will also be excluded from the study. informed consent and the report sheet prior to carrying out the study **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Cristian Carmona Cantalejo **Phone:** 681180357 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Rocío Martín Valero, PhD **Phone:** 951952858 **Role:** CONTACT #### Locations **Location 1:** **City:** Estación de Cártama **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Cristian Carmona Cantalejo - **Phone:** 681180357 - **Role:** CONTACT **Country:** Spain **Facility:** Cristian Carmona Cantalejo **State:** Málaga **Status:** RECRUITING **Zip:** 29580 #### Overall Officials **Official 1:** **Affiliation:** University of Malaga **Name:** Rocío Martín Valero **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003072 - Term: Cognition Disorders - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M29705 - Name: Cognitive Dysfunction - Relevance: HIGH - As Found: Cognitive Impairment - ID: M1175 - Name: Frailty - Relevance: HIGH - As Found: Frailty - ID: M6301 - Name: Cognition Disorders - Relevance: LOW - As Found: Unknown - ID: M21836 - Name: Neurocognitive Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000073496 - Term: Frailty - ID: D000060825 - Term: Cognitive Dysfunction ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06440720 **Acronym:** ELDOA **Brief Title:** COMPARATIVE EFFECTS OF ELDOA VERSES UPPER THORACIC MOBILIZATION AND MOBILITY EXERCISE FOR THE TREATMENT OF FHP **Official Title:** COMPARATIVE EFFECTS OF ELONGATION LONGITUDINAUX AVEC DECOAPTION OSTEO ARTICULAIRE VERSUS UPPER THORACIC MOBILIZATION AND MOBILITY EXERCISE FOR THE TREATMENT OF FORWARD HEAD POSTURES #### Organization Study ID Info **ID:** TUF/DR/SA/MSPP/2024/380 #### Organization **Class:** OTHER **Full Name:** University of Faisalabad ### Status Module #### Completion Date **Date:** 2024-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Faisalabad #### Responsible Party **Investigator Affiliation:** University of Faisalabad **Investigator Full Name:** Faiza Khalid **Investigator Title:** FAIZA KHALID **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study will compare the effectiveness of the Elongation Longitudinaux Avec Decoaptation Osteo Articulaire (ELDOA) method and upper thoracic mobilization and mobility exercises in correcting forward head posture (FHP). This study aims to evaluate the effectiveness of these methods in reducing forward head posture. The total sample size will be 36, with each group consisting of 18 participants. This study will be a randomized clinical trial. Participants who meet the inclusion criteria will be selected through screening and then assessed for outcomes using NPRS, a goniometer, the Neck Disability Index (NDI), and Web Plot Digitizer (WPD) Software. Statistical analysis will be conducted using SPSS version 27. **Detailed Description:** Study Title Comparative Effectiveness of the ELDOA Method and Upper Thoracic Mobilization and Mobility Exercises in Correcting Forward Head Posture: A Randomized Clinical Trial Introduction Forward Head Posture (FHP) is a common postural deformity characterized by an anterior positioning of the head relative to the vertical axis of the body. This condition can lead to various musculoskeletal issues, including neck pain, reduced range of motion, and increased disability. The Elongation Longitudinaux Avec Decoaptation Osteo Articulaire (ELDOA) method and upper thoracic mobilization and mobility exercises are two interventions aimed at correcting FHP. This study aims to compare the effectiveness of these two methods in reducing FHP and associated symptoms. Objectives The primary objective of this study is to evaluate and compare the effectiveness of the ELDOA method and upper thoracic mobilization and mobility exercises in reducing FHP. Secondary objectives include assessing improvements in pain levels, neck disability, and range of motion. Study Design This study is a randomized clinical trial. Participants A total of 36 participants will be recruited and randomly assigned to one of two intervention groups, each consisting of 18 participants. Inclusion Criteria * Adults aged 20-40 years * Diagnosed with forward head posture * Able to provide informed consent * No history of recent neck or upper thoracic surgery Exclusion Criteria * Severe musculoskeletal or neurological disorders * Recent injury to the neck or upper back * Pregnant or breastfeeding women Interventions Group A (ELDOA Method): Participants will undergo the ELDOA method, which involves specific postural exercises designed to create fascial tension and decompress the spine. Group B (Upper Thoracic Mobilization and Mobility Exercises)\*\*: Participants will receive upper thoracic mobilization techniques combined with mobility exercises aimed at improving posture and reducing FHP. Outcome Measures 1. Numerical Pain Rating Scale (NPRS): To assess the intensity of pain experienced by participants. 2. Goniometer: To measure the range of motion of the cervical spine. 3. Neck Disability Index (NDI): To evaluate the level of disability associated with neck pain. 4. Web Plot Digitizer (WPD) Software : To analyze and quantify postural changes from photographic data. Procedure 1. Screening and Baseline Assessment: Participants will be screened for eligibility and baseline measurements will be taken using NPRS, a goniometer, NDI, and WPD. 2. Randomization: Eligible participants will be randomly assigned to either the ELDOA group or the upper thoracic mobilization and mobility exercises group. 3. Intervention Period: Both groups will participate in their respective interventions over a period of 8 weeks, with sessions conducted twice a week. 4. Follow-Up Assessments : Outcomes will be reassessed at the end of the intervention period and compared to baseline values. Statistical Analysis Data will be analyzed using SPSS version 27. Descriptive statistics will be used to summarize baseline characteristics. Paired t-tests or Wilcoxon signed-rank tests will be used to compare pre- and post-intervention outcomes within groups. Independent t-tests or Mann-Whitney U tests will be employed to compare outcomes between the two groups. A significance level of p \< 0.05 will be considered statistically significant. Expected Outcomes It is hypothesized that both interventions will result in significant improvements in FHP, pain reduction, and decreased neck disability. However, the study aims to determine if one method is superior in achieving these outcomes. Ethical Considerations This study will adhere to ethical guidelines for clinical research. Informed consent will be obtained from all participants, and the study protocol will be reviewed and approved by an appropriate ethics committee. Conclusion This randomized clinical trial will provide valuable insights into the comparative effectiveness of the ELDOA method and upper thoracic mobilization and mobility exercises in correcting forward head posture. The findings could inform clinical practice and guide the development of targeted interventions for FHP. ### Conditions Module **Conditions:** - Postural, Thoracic Kyphosis - Postural; Defect **Keywords:** - Thoracic Mobilization - ELDOA - Mobility Exercise - Posture correction ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Study Design: Parallel Two-Group Randomized Controlled Trial Objective: To compare the effectiveness of the Elongation Longitudinaux Avec Decoaptation Osteo Articulaire (ELDOA) method versus upper thoracic mobilization and mobility exercises in treating forward head posture (FHP). Participants: Total sample size: 36 (18 in each group) Inclusion: Males and females, ages 20-40 years Exclusion: History of neck surgery, severe neck trauma Randomization: Participants will be randomly assigned to either the ELDOA group or the upper thoracic mobilization group using a computer-generated sequence. Interventions: Group A (ELDOA): Specific ELDOA exercises for FHP Group B (Upper Thoracic Mobilization): Exercises targeting thoracic mobility and FHP Outcome Measures: Primary outcomes: Numeric Pain Rating Scale (NPRS), goniometer measurements, Neck Disability Index (NDI), Web Plot Digitizer (WPD) Software ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 36 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Group A will receive ELDOA exercises. At first hot pack will applied for 7-8 minutes after that participants will explain specific body movements. Four ELDOA positions will once shown to the participants then ask them to maintain that positions. Once they make these positions stop watch will be set for one minute for each position. these positions will apply for three times per week for four weeks. **Intervention Names:** - Other: ELDOA ,UPPER THORACIC MOBILIZATION AND MOBILITY EXERCISE **Label:** Group A **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Group B will receive the UPPER THORACIC MOBILIZATION AND MOBILITY exercise. At first, a hot pack will be applied for 7-8 minutes after that participants will be in a prone position and the physiotherapist will stand toward the side where mobilization will be applied and the index and middle finger of the left hand of the physiotherapist will be placed on the vertebral transverse processes of the participants to the caudal side. The lateral side of the palm of the right hand will be placed over the left-hand index and middle finger and then thoracic mobilization after that mobility exercise will be performed. **Intervention Names:** - Other: ELDOA ,UPPER THORACIC MOBILIZATION AND MOBILITY EXERCISE **Label:** Group-B **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Group A - Group-B **Description:** Already mentioned **Name:** ELDOA ,UPPER THORACIC MOBILIZATION AND MOBILITY EXERCISE **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The primary outcome measure was the CVA, which was calculated using each participant's profile photo. The self-balanced posture assessment method was used to force the participants to maintain their typical head posture. By drawing a vertical line from Targus to the seventh cervical vertebrae and a horizontal line across them, the angle between them may be calculated to determine the CVA angle. The CVA measurement was shown to have excellent reliability in a prior research. **Measure:** Craniovertebral angle **Time Frame:** 5 Minutes #### Secondary Outcomes **Description:** Cervical ranges of motion ( CROM) cervical flexion, extension, right Side bending, left Side bending, right rotation and left rotation were measured using goniometer **Measure:** Cervical ranges of motion **Time Frame:** 20 Minutes **Description:** The NPRS scale, which has good reliability and validity in prior research, was utilized to measure the degree of present pain. 0: No pain 1 - 3: Mild pain 4 - 6: Moderate pain 7 - 10: Severe pain **Measure:** Numeric Pain Rating Scale **Time Frame:** 5 Minutes **Description:** The cervical spine's disability index was assessed using the NDI. It consists of 10 items, each scored on a 0 to 5 scale, with the total score ranging from 0 to 50. The NDI score can be expressed as a percentage by multiplying the raw score by 2. The interpretation of the NDI score is typically as follows: 0 - 4 (0% - 8%): No disability 5 - 14 (10% - 28%): Mild disability 15 - 24 (30% - 48%): Moderate disability 25 - 34 (50% - 68%): Severe disability 35 - 50 (70% - 100%): Complete disability **Measure:** Neck disability Index **Time Frame:** 10 minutes ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Both males and females. * Age between 20 to 40 years. * Patients having complain of neck pain * Patients having forward head posture * Patients having limited Cervical range of motion * Patients having Craniovertebral angle CVA less than 50. * Pain more than 3 on NPRS scale with FHP Exclusion Criteria: * History of whiplash injury within 3 months of examination. * History of tumor * History of surgery of cervical or thoracic spine. * Positive neurological signs * Congenital deformity * Patients having pathology and infection in spine. * Patients having severe osteoporosis **Healthy Volunteers:** True **Maximum Age:** 40 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Faisalābad **Country:** Pakistan **Facility:** Govt Teaching Hospital GM Abad **State:** Punjab **Zip:** 38000 #### Overall Officials **Official 1:** **Affiliation:** The University of Faisalabad **Name:** Faiza Khalid, MSPT **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Kripa S KH. Identifying relations between posture and pain in lower back pain patients: a narrative review. Bulletin of Faculty of Physical Therapy. **Citation:** Waqar S, Faculty of Rehabilitation & Allied Health Sciences RIU, Islamabad. Pakistan, Khalid M, Faculty of Rehabilitation & Allied Health Sciences RIU, Islamabad. Pakistan, Khalid N, Islamabad Physiotherapy & Rehabilitation Centre BT. EFFECTIVENESS OF ELONGATION LONGITUDINAUX AVEC DECOAPTION OSTEOARTICULAIRE IN CORRECTING FORWARD HEAD POSTURE. The Rehabilitation Journal. 2022;volume no.6. **Citation:** Cho J, Lee E, Lee S. Upper thoracic spine mobilization and mobility exercise versus upper cervical spine mobilization and stabilization exercise in individuals with forward head posture: a randomized clinical trial. BMC Musculoskelet Disord. 2017 Dec 12;18(1):525. doi: 10.1186/s12891-017-1889-2. **PMID:** 29233164 **Citation:** Weon JH, Oh JS, Cynn HS, Kim YW, Kwon OY, Yi CH. Influence of forward head posture on scapular upward rotators during isometric shoulder flexion. J Bodyw Mov Ther. 2010 Oct;14(4):367-74. doi: 10.1016/j.jbmt.2009.06.006. Epub 2009 Jul 22. **PMID:** 20850044 **Citation:** Farooq M, Bashir MS, Arif A, Kashif M, Manzoor N, Abid F. Effects of elongation longitudinaux avec decoaption osteo-articulaire and post-facilitation stretching technique on pain and functional disability in mobile users with text neck syndrome during COVID-19 pandemic: A randomized controlled trial. Medicine (Baltimore). 2023 Mar 24;102(12):e33073. doi: 10.1097/MD.0000000000033073. **PMID:** 36961169 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013121 - Term: Spinal Curvatures - ID: D000013122 - Term: Spinal Diseases - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10758 - Name: Kyphosis - Relevance: HIGH - As Found: Kyphosis - ID: M15918 - Name: Spinal Curvatures - Relevance: LOW - As Found: Unknown - ID: M15919 - Name: Spinal Diseases - Relevance: LOW - As Found: Unknown - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007738 - Term: Kyphosis ### 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:** NCT06440707 **Brief Title:** [Trial of device that is not approved or cleared by the U.S. FDA] **Official Title:** [Trial of device that is not approved or cleared by the U.S. FDA] #### Organization Study ID Info **ID:** 24-000780 #### Organization **Full Name:** [Redacted] ### Status Module **Delayed Posting:** True #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-05 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-03 **Overall Status:** WITHHELD #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor **Name:** [Redacted] #### Responsible Party **Old Name Title:** [Redacted] **Old Organization:** [Redacted] ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06440694 **Brief Title:** Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis (The Conquer-DVT Pilot Trial) **Official Title:** Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis: A Randomized Controlled Pilot Trial #### Organization Study ID Info **ID:** CONQUER-DVT Pilot #### Organization **Class:** OTHER **Full Name:** Ottawa Hospital Research Institute ### Status Module #### Completion Date **Date:** 2027-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-03 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-28 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ottawa Hospital Research Institute #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Purpose of the pilot trial: To assess the feasibility of a full-scale, double-blind, placebo-controlled, randomized trial assessing whether low-dose colchicine (0.5 mg daily) reduces the risk of post-thrombotic syndrome (PTS) in patients with proximal lower extremity deep vein thrombosis (DVT). **Detailed Description:** Eligible and consenting patients will be randomized via a central web-based randomization system (1:1 ratio) to receive one tablet of colchicine 0.5 mg or identical matching placebo daily starting within 7 days of initiation of anticoagulation for acute, symptomatic, proximal lower extremity Deep Vein Thrombosis (DVT) for a treatment course of 180 days (+/- 7 days). Study drug will start within 24 hours of randomization. The type, dose, and duration of anticoagulant therapy : unfractionated heparin, Low Molecular Weight Heparin (LMWH), fondaparinux, Direct Oral Anticoagulation (DOAC) or Vitamin K Agonist (VKA) will be left to the discretion of the treating physician or local investigator. The study drug will be continued until the end of the treatment period (180 days +/- 7 days). All patients will be observed until the end of study follow-up (365 days +/- 7 days). ### Conditions Module **Conditions:** - Venous Thromboembolism **Keywords:** - Proximal Lower Extremity Deep Vein Thrombosis - Randomized Trial - Colchicine - Post Thrombotic Syndrome - Inflammation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized Controlled Pilot Trial comparing two groups - Colchicine 0.5 mg po once daily for 180 days vs Placebo 0.5 mg po once daily for 180 days. ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Colchicine 0.5 mg po once daily for 180 days. After the Day - 180 follow up, the study treatment will be discontinued and subsequent treatment will be at the discretion of the attending physician. **Intervention Names:** - Drug: Colchicine 0.5 mg po **Label:** Experimental Arm: Colchicine **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Placebo 0.5 mg po once daily for 180 days. After the Day - 180 follow up, the study treatment will be discontinued and subsequent treatment will be at the discretion of the attending physician. **Intervention Names:** - Drug: Placebo 0.5 mg po **Label:** Control Arm : Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental Arm: Colchicine **Description:** Colchicine 0.5 mg po once daily for 180 days. **Name:** Colchicine 0.5 mg po **Other Names:** - Myinfla tablet 0.5 mg po daily **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Control Arm : Placebo **Description:** Placebo 0.5 mg po once daily for 180 days. **Name:** Placebo 0.5 mg po **Other Names:** - Placebo 0.5 mg po daily **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Mean number of participants recruited per site per month **Measure:** Pilot Trial Primary Outcome: Recruitment Rate **Time Frame:** 12 months **Description:** V. score ≥5 **Measure:** Full-Scale Trial Primary Outcome: Post Thrombotic Syndrome **Time Frame:** 180 days #### Secondary Outcomes **Description:** Proportion of screened patients who are eligible **Measure:** Pilot Trial Secondary Outcome: Eligibility Rate **Time Frame:** 12 months **Description:** Proportion of eligible patients who provide consent **Measure:** Pilot Trial Secondary Outcome: Consent Rate **Time Frame:** 12 months **Description:** Proportion of participants retained at follow-up **Measure:** Pilot Trial Secondary Outcome: Retention Rate **Time Frame:** 12 months **Description:** Proportion of participants who completed all study procedures **Measure:** Pilot Trial Secondary Outcome: Study Completion Rate **Time Frame:** 12 months **Description:** Adherence to study drug measured by pill count at the end of follow-up **Measure:** Pilot Trial Secondary Outcome: Adherence Rate **Time Frame:** 12 months **Description:** Pilot Trial Secondary Outcome: Reasons for declining participation **Measure:** Pilot Trial Secondary Outcome: Reasons for declining participation **Time Frame:** 12 months **Description:** V. score ≥5 **Measure:** Full-Scale Trial Secondary Outcome: Post Thrombotic Syndrome **Time Frame:** 365 days **Description:** V. score ≥ 15 or presence of ulcer **Measure:** Full-Scale Trial Secondary Outcome: Severe Post Thrombotic Syndrome **Time Frame:** 180 and 365 days **Description:** Continuous V. score **Measure:** Full-Scale Trial Secondary Outcome: Severity of Post Thrombotic Syndrome **Time Frame:** 180 and 365 days **Description:** Full-Scale Trial Secondary Outcome: Patient Reported V. Scale **Measure:** Full-Scale Trial Secondary Outcome: Patient Reported V. Scale **Time Frame:** 180 and 365 days **Description:** Full-Scale Trial Secondary Outcome: Recurrent Venous Thromboembolism **Measure:** Full-Scale Trial Secondary Outcome: Recurrent Venous Thromboembolism **Time Frame:** 180 and 365 days **Description:** As per International Society on Thrombosis and Haemostasis (ISTH) definition **Measure:** Full-Scale Trial Secondary Outcome: Major Bleeding **Time Frame:** 180 and 365 days **Description:** As per ISTH definition **Measure:** Full-Scale Trial Secondary Outcome: Clinically Relevant Non-Major Bleeding **Time Frame:** 180 and 365 days **Description:** Full-Scale Trial Secondary Outcome: Overall Mortality **Measure:** Full-Scale Trial Secondary Outcome: Overall Mortality **Time Frame:** 180 and 365 days **Description:** Scoring using VEINES-QOL/Sym **Measure:** Full-Scale Trial Secondary Outcome: Venous disease Specific Quality of Life **Time Frame:** 180 and 365 days **Description:** Scoring using EuroQoL-EQ-5D-5L **Measure:** Full-Scale Trial Secondary Outcome: Health-Related Quality of Life **Time Frame:** 180 and 365 days **Description:** Full-Scale Trial Secondary Outcome: Incremental Cost-Effectiveness Ratio (ICER) **Measure:** Full-Scale Trial Secondary Outcome: Incremental Cost-Effectiveness Ratio (ICER) **Time Frame:** 180 and 365 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Consenting patients 18 years of age or older with a first, acute, symptomatic proximal (popliteal vein or more proximal) objectively confirmed DVT of the lower extremity will be eligible to participate in the study. Exclusion Criteria: 1. History of an allergic reaction or significant sensitivity to colchicine. 2. Requirement of colchicine for other indications. 3. Active or chronic diarrhea, or documented inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis), collagenous colitis or irritable bowel syndrome or existing blood dyscrasias. 4. Known or suspected, recent (\<30 days) or active infections (acute or chronic). 5. History of cirrhosis, chronic active hepatitis, or severe liver disease. 6. Recent (\<30 days) or chronic use of systemic (oral, intravenous) immunosuppressive drugs (including but not limited to steroids, tumor necrosis factor-alpha blockers, cyclosporine). 7. Known active cancer. 8. Any of the following as measured within the past 1-3 months or at screening: alanine, or aspartate aminotransferase \>3 times the upper limit of normal, total bilirubin \>2 times the upper limit of normal and a creatinine clearance by Cockcroft-Gault formula \<30 mL/min. 9. Pregnancy, breast feeding or may be considering pregnancy during the study period or women of childbearing potential unwilling to use appropriate contraception during sex; 10. The use of medication with known drug-to-drug interactions (including but not limited to erythromycin or clarithromycin). 11. Unable or unwilling to provide consent. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Marc Carrier, MD, MSc **Phone:** 6137378899 **Phone Ext:** Ext. 73668 **Role:** CONTACT #### Locations **Location 1:** **City:** Ottawa **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Marc Carrier, MD,MSc - **Phone:** 6137378899 - **Phone Ext:** Ext. 73668 - **Role:** CONTACT **Country:** Canada **Facility:** The Ottawa Hospital General Campus **State:** Ontario **Zip:** K1H 8L6 #### Overall Officials **Official 1:** **Affiliation:** Ottawa Hospital Research Institute / Division of Hematology- The Ottawa Hospital **Name:** Marc Carrier, MD, MSc **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Contact Principal Investigator **Description:** To be developed **Info Types:** - STUDY_PROTOCOL - SAP - CSR **IPD Sharing:** YES **Time Frame:** Upon completion of the full-scale trial ## Derived Section ### Condition Browse Module - Ancestors - ID: D000016769 - Term: Embolism and Thrombosis - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases ### Condition Browse Module - Browse Leaves - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M16682 - Name: Thromboembolism - Relevance: HIGH - As Found: Thromboembolism - ID: M27780 - Name: Venous Thromboembolism - Relevance: HIGH - As Found: Venous Thromboembolism - ID: M16686 - Name: Thrombosis - Relevance: HIGH - As Found: Thrombosis - ID: M22071 - Name: Venous Thrombosis - Relevance: HIGH - As Found: Deep Vein Thrombosis - ID: M27556 - Name: Postthrombotic Syndrome - Relevance: LOW - As Found: Unknown - ID: M14068 - Name: Postphlebitic Syndrome - Relevance: LOW - As Found: Unknown - ID: M7784 - Name: Embolism - Relevance: LOW - As Found: Unknown - ID: M19128 - Name: Embolism and Thrombosis - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013927 - Term: Thrombosis - ID: D000013923 - Term: Thromboembolism - ID: D000054556 - Term: Venous Thromboembolism - ID: D000020246 - Term: Venous Thrombosis ### Intervention Browse Module - Ancestors - ID: D000006074 - Term: Gout Suppressants - ID: D000018501 - Term: Antirheumatic Agents - ID: D000050257 - Term: Tubulin Modulators - ID: D000050256 - Term: Antimitotic Agents - ID: D000050258 - Term: Mitosis Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M6307 - Name: Colchicine - Relevance: HIGH - As Found: Observed - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: M26197 - Name: Tubulin Modulators - Relevance: LOW - As Found: Unknown - ID: M26196 - Name: Antimitotic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000003078 - Term: Colchicine ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06440681 **Brief Title:** Effects of Lifestyle Intervention in the Biological Aging in Prediabetes **Official Title:** Effects of a 6-month Lifestyle Intervention Program in the DNAm PhenoAge, SOST, and GDF15 Markers of Biological Aging in Adults With Prediabetes #### Organization Study ID Info **ID:** IRB log Number:2024-8 #### Organization **Class:** OTHER **Full Name:** King Saud University ### Status Module #### Completion Date **Date:** 2025-11-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-08-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** King Saud University #### Responsible Party **Investigator Affiliation:** King Saud University **Investigator Full Name:** Ahmed Shafi Alenezi **Investigator Title:** Dr **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Lifestyle modifications, including dietary changes and increased physical activity, play a crucial role in controlling complications to reduce or eliminate them. As well as controlling disturbances in biochemical markers such as DNAm PhenoAge, and signs of aging such as circulating sclerostin (SOST) and growth differentiation factor 15 (GDF15). This study seeks to address this dilemma by focusing on specific groups of elderly Saudis with prediabetes . Lifestyle changes in elderly Saudis with prediabetes show promise in reducing or eliminating complications. The potential insights derived from this research extend beyond academia, offering tangible benefits for clinical practice and public health The proposed study will be implemented to achieve the following objective: 1. To determine changes in DNAm PhenoAge of elderly Saudis with prediabetes who underwent a 6-month lifestyle modification program. 2. To determine changes in other candidate senescence markers such as circulating sclerostin (SOST) and growth differentiation factor 15 (GDF15) of elderly Saudis with prediabetes who underwent a 6-month lifestyle modification program. **Detailed Description:** Data Collection Baseline assessments will include anthropometric measurements, blood pressure, blood sample tests and submission of self-administered questionnaires which included demographics and medical history, as well as assessment of dietary intake via a validated food frequency questionnaire. The assessments will be repeated twice (at baseline and 6 months) in both groups. Anthropometrics Anthropometric measurements will be conducted by well-trained medical staff. Height (m) and weight (kg) will be measured with light clothing without shoes. Waist and hip circumferences (cm) will be measured using standard tape measure. BMI will be calculated by dividing weight in kg by the height in meters squared. Blood pressure will be measured at each visit after sufficient rest. Blood Collection Fasting blood samples will be collected using a sterile vacutainer blood collection apparatus. Biological age blood tests will be measured by auto-analysers at the in-house laboratory of participating primary health centres (PHCs). The tests will include complete blood count, serum albumin, creatinine, fasting glucose,C reactive protein and alkaline phosphatase . From these tests the DNAm PhenoAge will be calculated through an online platform (httas://thrivous.com/pages/biological-age calculator). Other senescence markers such as SOST and DGF-15 will be measure using commercially available assays. Outcomes: DNAm PhenoAge (primary), SOST and GDF15 (secondary) Blood tests for biological age will be performed in the Arar Central Hospital laboratory (North Medical Tower) by the following apparatus : * Sysmex XN-1000 to perform CBC tests, and the analysis Techniques as follows: * Size-based cell counting analysis is done using flow cytometry Technique. * Hemoglobin measurement analysis is done using spectrophotometry. * Differential counting analysis using Histochemistry technique. * The other tests are done through mathematical equations. Roch Cobas C501 and SIEMENS Dimension EXL200 for performing chemistry analyzes (FBS, albumin, creatinine and alkaline phosphatase), and these analyzes work with Spectrophotometry technology. SIEMENS BN ProSpec NEPH630 to perform C reactive protein analysis using Turbidimetry technology. Also, all devices undergo daily control tests, as well as monthly external quality tests using Randox International Quality Assessment Scheme ( RIQAS ), and annual validation tests according to approved protocols. Note: that Arar Central Hospital has an accreditation certificate from the Saudi Central Broad for Accreditation of Health Institutions (CBAHI). Intervention A 6-month lifestyle modification program will be launched at primary health centers in Arar, Saudi Arabia. 500 participants will be involved and all participants will be advised to: 1. Reducing weight (5% of the basic weight), 2. Exercise (4 hours/week), 3. Moderate fat consumption (total fat 30% of total energy intake and saturated fat 10%). % of total energy consumed), 4. A diet rich in fiber (15 g/1000 calories). 5. Participants will receive individual, detailed, ongoing nutritional counseling by the study dietitian every two weeks. 6. They will also be encouraged to participate in physical activities. The table below shows the detailed intervention for both groups. Finally, the participants will be divided into two groups: 7. Lifestyle Modification Group (LMP): those who agreed and followed the previous instructions and advice. 8. Control group (CG): those who did not receive health education or did not follow previous instructions or advice. ### Conditions Module **Conditions:** - PreDiabetes - Marker; Structural **Keywords:** - DNAm PhenoAge, Lifestyle modification ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** A 6-month lifestyle modification program will be launched at primary health centers in Arar, Saudi Arabia. 500 participants will be involved and all participants will be advised to: Reducing weight (5% of the basic weight), Exercise (4 hours/week), Moderate fat consumption (total fat 30% of total energy intake and saturated fat 10%). % of total energy consumed), A diet rich in fiber (15 g/1000 calories). Participants will receive individual, detailed, ongoing nutritional counseling by the study dietitian every two weeks. They will also be encouraged to participate in physical activities. The table below shows the detailed intervention for both groups. Finally, the participants will be divided into two groups: Lifestyle Modification Group (LMP): those who agreed and followed the previous instructions and advice. Control group (CG): those who did not receive health education or did not follow previous instructions or advice. ##### Masking Info **Masking:** SINGLE **Masking Description:** There is nothing masked to study **Who Masked:** - PARTICIPANT **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** They are the people who will follow the lifestyle modification program, which is: Dietary counseling and monitoring: reduce fat intake (30% of total energy and saturated fat 10% of total energy) and increase fiber intake (15 g/1000 kcal) in the diet Physical activity: moderate exercise (150 minutes/week) **Intervention Names:** - Other: Providing nutritional counselling, monitoring and counseling on physical activity **Label:** Lifestyle Modification Group (LMP) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** They are people who will not follow the lifestyle modification program or they did not know about this program **Intervention Names:** - Other: Providing nutritional counselling, monitoring and counseling on physical activity **Label:** Control group (CG) **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Control group (CG) - Lifestyle Modification Group (LMP) **Description:** Intervention is lifestyle modification Dietary counseling and monitoring: reduce fat intake (30% of total energy and saturated fat 10% of total energy) and increase fiber intake (15 g/1000 kcal) in the diet Physical activity: moderate exercise (150 minutes/week) Anthropometric measurements will be taken and a blood sample will be taken to perform biological age tests, which are: Albumin Creatinine Glucose (fasting) C-Reactive Protein Lymphocyte (%) Mean Cell Volume (MCV) Red Cell Distribution Width (RDW) Alkaline Phosphatase White Blood Cell Count (WBC) Age (years) It is done twice at the beginning and after six months **Name:** Providing nutritional counselling, monitoring and counseling on physical activity **Other Names:** - Biological Age markers **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Change in Albumin (g/L) **Measure:** Change in Age marker Albumin post intervention **Time Frame:** 6 months **Description:** Change in fasting glucose (mmol/L) **Measure:** Change in Age marker fasting glucose post intervention **Time Frame:** 6 months **Description:** Change in Creatinine (umol/L) **Measure:** Change in Age marker Creatinine post intervention **Time Frame:** 6 months **Description:** Change in C-Reactive Protein (mg/dL) **Measure:** Change in Age marker C-Reactive Protein post intervention **Time Frame:** 6 months **Description:** Change in Alkaline Phosphatase (U/L) **Measure:** Change in Age marker Alkaline Phosphatase post intervention **Time Frame:** 6 months **Description:** Change in White Blood Cell Count (WBC) (10\^3/uL) **Measure:** Change in Age marker White Blood Cell Count (WBC) post intervention **Time Frame:** 6 months **Description:** Change in Lymphocyte (%) **Measure:** Change in Age marker Lymphocyte post intervention **Time Frame:** 6 months **Description:** Change in Mean Cell Volume (MCV) (fL) **Measure:** Change in Age marker Mean Cell Volume (MCV) post intervention **Time Frame:** 6 months **Description:** Change in Red Cell Distribution Width (RDW) (%) **Measure:** Change in Age marker Red Cell Distribution Width (RDW) post intervention **Time Frame:** 6 months #### Secondary Outcomes **Description:** Change in SOST(pmol/L) **Measure:** Change in Age marker SOST post intervention **Time Frame:** 6 months **Description:** Change in GDF15 (10\^3 pg/mL) **Measure:** Change in Age marker GDF15 post intervention **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Clinical diagnosis of pre-diabetes for all Saudis aged 30 years and above, males and females 2. They must be able to exercise and be able to follow a diet Exclusion Criteria 1. Insulin-dependent diabetes and non-diabetic patients 2. People with diseases that prevent them from participating and doing exercises **Maximum Age:** 80 Years **Minimum Age:** 30 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ahmed S Alenezi, PhD **Phone:** 00966505384985 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Shaun B Sabico, M.D.PhD **Phone:** 00966114675939 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** King Saud University **Name:** Shaun B Sabico, M.D.PhD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003920 - Term: Diabetes Mellitus - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000006943 - Term: Hyperglycemia ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14117 - Name: Prediabetic State - Relevance: HIGH - As Found: Prediabetes - ID: M20295 - Name: Glucose Intolerance - Relevance: HIGH - As Found: Prediabetes - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M9994 - Name: Hyperglycemia - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011236 - Term: Prediabetic State - ID: D000018149 - Term: Glucose Intolerance ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False