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## Protocol Section ### Identification Module **NCT ID:** NCT06439368 **Brief Title:** Effect of Dezocine Combined With Sufentanil on the Quality of Postoperative Recovery and Analgesic Effect in Patients Undergoing Thoracic Surgery **Official Title:** Effect of Dezocine Combined With Sufentanil on the Quality of Postoperative Recovery and Analgesic Effect in Patients Undergoing Thoracic Surgery: a Randomized, Double-blind, Parallel-controlled, Multicenter Clinical Study #### Organization Study ID Info **ID:** NFEC-2023-005 #### Organization **Class:** INDUSTRY **Full Name:** Yangtze River Pharmaceutical Group Co., Ltd. ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-01-05 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Nanfang Hospital, Southern Medical University #### Lead Sponsor **Class:** INDUSTRY **Name:** Yangtze River Pharmaceutical Group Co., Ltd. #### 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 evaluate the effect of dezocine combined with sufentanil on postoperative recovery quality and analgesic effect in patients undergoing thoracic surgery. It will also learn about the safety of dezocine. Researchers will compare drug dezocine to Sufentanil to see if dezocine works to Improve postoperative pain and recovery quality for patients. Participants will undergo elective surgery and receive PCIA postoperatively，taking dezocine combine with sufentanil,or only sufentanil respectively. Visit the VAS score after connecting the analgesic pump 24h and 48h，and evaluate the Quality of Recovery -15 score. ### Conditions Module **Conditions:** - Rehabilitation - Postoperative Pain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 210 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** At the end of the operation, dezocine 1.0 mg/kg + sufentanil 2.0 ug/kg (prepared as 200 ml, background volume 2 ml/h, single dose 2 ml/time, locking time 15 min) was uniformly administered by PCIA; 3 ml test dose was administered immediately after the analgesic pump was connected at the end of the operation, and continuous analgesia was performed for 48 hours after the operation. **Intervention Names:** - Drug: Dezocine **Label:** Test group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** At the end of the operation, sufentanil injection 3.0 ug/kg (prepared as 200 ml, background volume 2 ml/h, single dose 2 ml/time, locking time 15 min) was uniformly administered by PCIA; 3 ml test dose was immediately administered after the analgesic pump was connected at the end of the operation, and continuous analgesia was performed for 48 hours after the operation. **Intervention Names:** - Drug: Dezocine **Label:** Control group **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Control group - Test group **Description:** At the end of the operation, dezocine 1.0 mg/kg + sufentanil 2.0 ug/kg (prepared as 200 ml, background volume 2 ml/h, single dose 2 ml/time, locking time 15 min) was uniformly administered by PCIA; 3 ml test dose was administered immediately after the analgesic pump was connected at the end of the operation, and continuous analgesia was performed for 48 hours after the operation. **Name:** Dezocine **Other Names:** - sufentanil **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** QoR-15 is Quality of recovery-15,score ranges from 0 (QoR extremely poor) to 150 (QoR extremely good) **Measure:** QoR-15 score at 24 hours after connection to analgesic pump **Time Frame:** 24 hours #### Secondary Outcomes **Description:** QoR-15 is Quality of recovery-15,score ranges from 0 (QoR extremely poor) to 150 (QoR extremely good) **Measure:** QoR-15 score at 48 hours after connection to analgesic pump **Time Frame:** 48 hours **Description:** QoR-15 is Quality of recovery-15,score ranges from 0 (QoR extremely poor) to 150 (QoR extremely good) **Measure:** Proportion of patients with ≥ 8 points increase in QoR-15 score from baseline at 24hours and 48hours after connection to analgesic pump **Time Frame:** 24 hours and 48 hours **Measure:** Patient global impression of change score at 48 hours after connection to analgesia pump **Time Frame:** 48 hours **Measure:** Static NRS score at 2hours, 4hours, 6hours, 12hours, 24hours, 36hours, 48hours after connection to analgesia pump **Time Frame:** 2hours, 4hours, 6hours, 12hours, 24hours, 36hours, 48hours **Measure:** Number of effective compressions of analgesic pump with in 48 hours after connection of analgesic pump **Time Frame:** 48 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients undergoing elective thoracoscopic surgery under general anesthesia, and patients with moderate to severe pain requiring opioids or opioid-non-opioids combined analgesia after surgery as assessed by the investigator; 2. 18 to 65 years of age, male or female; 3. Body mass index (BMI) between 18-30 kg/m ² (BMI = body weight (kg)/height ² (m ²)), including borderline values; 4. Modified Mahalanobis score \< III; 5. ASA grade I \~ III; 6. Voluntarily signed informed consent. Exclusion Criteria: 1. Inability to understand the nature, significance, possible benefits, possible inconveniences and potential risks of the trial, or inability to understand the study procedures and pain-related assessment methods; 2. Patients who cannot accept the postoperative analgesia specified in the protocol; 3. Clinician judgment: liver and kidney dysfunction has clinical significance (ALT and AST \> 2 times the upper limit of normal; BUN and/or Urea \> 2 times the upper limit of normal, Cr \> 2 times the upper limit of normal; dialysis treatment within 28 days before surgery), or coagulation dysfunction has clinical significance (PT or APTT or TT \> the upper limit of normal), or poor blood pressure control (sitting SBP \> 160 mmHg or SBP \< 90 mmHg), or oxygen saturation (without oxygen) \< 94%; 4. Patients with high risk of respiratory depression or respiratory depression (such as sleep apnea syndrome); 5. Patients who are allergic to the test drugs (dezocine, sufentanil); 6. History of bronchial asthma; 7. Patients with hypothyroidism; 8. Patients with uncontrolled gastrointestinal ulcers, gastrointestinal bleeding or perforation before surgery; or patients with paralytic ileus; 9. Patients with chronic (continuous 3 months or intermittent up to 6 months) pain associated with non-surgical sites; 10. Craniocerebral injury, possible intracranial hypertension, cerebral aneurysm, cerebrovascular accident history or suffering from central nervous system diseases (such as epilepsy); 11. Suffering from mental system diseases (such as depression), or long-term use of psychotropic drugs; 12. Patients who cannot evaluate the pain intensity after surgery or are transferred to ICU; 13. Evidence of severe cardiac dysfunction (NYHA class III and IV), unstable angina pectoris or acute myocardial infarction within 6 months before enrollment; 14. Estimated operative blood loss greater than 1000 ml or other serious complications during surgery; 15. Patients with a history of drug abuse, drug abuse and alcohol abuse within 2 years before the start of the screening period; Alcohol abuse was defined as regular consumption of more than 14 drinks/week (1 drink = 150 mL wine or 360 mL beer or 45 mL spirits); 16. Patients who have been taking opioids for a long time (continuous use for 1 month or intermittent use for up to 3 months), or who are tolerant to opioids; 17. Patients who have used monoamine oxidase inhibitors within 2 weeks; 18. Participating in any clinical trial as a subject within 3 months; 19. Pregnant or lactating women or patients with fertility plan within 6 months (including men); 20. Patients who are judged unsuitable for participation by other investigators. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** fengsw@yangzijiang.com **Name:** Shiwei Feng **Phone:** +86 181 1598 6602 **Role:** CONTACT #### Locations **Location 1:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Email:** Licaisysu@163.com - **Name:** Cai Li - **Phone:** +86 150 6101 9142 - **Role:** CONTACT **Country:** China **Facility:** Nanfang Hospital of Southern Medical University **State:** Guangzhou **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Nanfang Hospital, Southern Medical University **Name:** Kexuan Liu **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M13069 - Name: Pain, Postoperative - Relevance: HIGH - As Found: Postoperative Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010149 - Term: Pain, Postoperative ### Intervention Browse Module - Ancestors - ID: 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: D000000759 - Term: Adjuvants, Anesthesia - ID: D000018686 - Term: Anesthetics, Intravenous - ID: D000018681 - Term: Anesthetics, General - ID: D000000777 - Term: Anesthetics ### Intervention Browse Module - Browse Branches - Abbrev: AdjAn - Name: Adjuvants, Anesthesia - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M19684 - Name: Sufentanil - Relevance: HIGH - As Found: Decrease - ID: M256070 - Name: Dezocine - Relevance: HIGH - As Found: CXCR4 - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M117729 - Name: Dsuvia - Relevance: LOW - As Found: Unknown - ID: M4033 - Name: Analgesics, Opioid - Relevance: LOW - As Found: Unknown - ID: M12245 - Name: Narcotics - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4089 - Name: Adjuvants, Anesthesia - Relevance: LOW - As Found: Unknown - ID: M20766 - Name: Anesthetics, Intravenous - Relevance: LOW - As Found: Unknown - ID: M20761 - Name: Anesthetics, General - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000017409 - Term: Sufentanil - ID: C000010827 - Term: Dezocine ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06439355 **Acronym:** PI-PEG **Brief Title:** Single-center Study of Gustation in Idiopathic Parkinson's Disease and Lewy Body Disease Using Gustatory Evoked Potential Analysis **Official Title:** Single-center Study of Gustation in Idiopathic Parkinson's Disease and Lewy Body Disease Using Gustatory Evoked Potential Analysis #### Organization Study ID Info **ID:** SCHNEIDER J'InvEST-I 2023 #### Organization **Class:** OTHER **Full Name:** Centre Hospitalier Universitaire Dijon ### Status Module #### Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **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:** Centre Hospitalier Universitaire Dijon #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The aim of the PI-PEG study is to explore the taste functions of the following 3 groups of participants: * healthy volunteers * patients with early Parkinson's disease * patients with incipient Lewy body disease. To this end, the results obtained from taste evoked potentials in each of the 3 groups of participants will be compared with each other and with different nutritional, motor and cognitive data. This study could reveal a difference in cortical processing of gustatory sensory information between patients who have had idiopathic Parkinson's disease progressing for 3 years or less, and patients who have had Lewy body disease progressing for 3 years or less. Indeed, a modification of taste evoked potentials (in terms of latencies) proportional to the degree of cerebral degeneration could be observed. ### Conditions Module **Conditions:** - Idiopathic Parkinson's Disease and Lewy Body Disease ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 66 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Biological: Fasting blood test - Other: Subject interview - Other: Motor assessment - Other: Neurocognitive assessment - Other: Nutritional assessment - Other: Taste tests **Label:** Healthy volunteers **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Biological: Fasting blood test - Other: Subject interview - Other: Motor assessment - Other: Neurocognitive assessment - Other: Nutritional assessment - Other: Taste tests **Label:** Patients with Idiopathic Parkinson's Disease (IPD) of course ≤ 3 years **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Biological: Fasting blood test - Other: Subject interview - Other: Motor assessment - Other: Neurocognitive assessment - Other: Nutritional assessment - Other: Taste tests **Label:** Patients with Lewy body disease (LBD) progressing ≤ 3 years **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Healthy volunteers - Patients with Idiopathic Parkinson's Disease (IPD) of course ≤ 3 years - Patients with Lewy body disease (LBD) progressing ≤ 3 years **Description:** metabolic assays determination of food intake hormones oxidative stress and neurodegeneration marker assays **Name:** Fasting blood test **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Healthy volunteers - Patients with Idiopathic Parkinson's Disease (IPD) of course ≤ 3 years - Patients with Lewy body disease (LBD) progressing ≤ 3 years **Description:** socio-demographic data, medical and family history, treatment taken **Name:** Subject interview **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Healthy volunteers - Patients with Idiopathic Parkinson's Disease (IPD) of course ≤ 3 years - Patients with Lewy body disease (LBD) progressing ≤ 3 years **Description:** MDS-UPDRS scale PART III **Name:** Motor assessment **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - Healthy volunteers - Patients with Idiopathic Parkinson's Disease (IPD) of course ≤ 3 years - Patients with Lewy body disease (LBD) progressing ≤ 3 years **Description:** MoCA and MMSE scales **Name:** Neurocognitive assessment **Type:** OTHER #### Intervention 5 **Arm Group Labels:** - Healthy volunteers - Patients with Idiopathic Parkinson's Disease (IPD) of course ≤ 3 years - Patients with Lewy body disease (LBD) progressing ≤ 3 years **Description:** anthropometric data (weight, height, BMI, waist circumference, hip circumference, android/gynoid ratio, triceps skin fold, brachial circumference), bioelectrical impedancemetry (fat mass, lean mass, water mass and bone mass) **Name:** Nutritional assessment **Type:** OTHER #### Intervention 6 **Arm Group Labels:** - Healthy volunteers - Patients with Idiopathic Parkinson's Disease (IPD) of course ≤ 3 years - Patients with Lewy body disease (LBD) progressing ≤ 3 years **Description:** Recording of PEGs in response to a sucrose solution and a free fatty acid solution (prepared beforehand) **Name:** Taste tests **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Average latency of taste-evoked potentials **Time Frame:** After a 2-hour fasting period ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Healthy volunteers: * Person who has given written consent * Adult * Enrolled in the national register of healthy volunteers * Fasting \> 2 hours before PEG measurement * Body Mass Index (BMI) \< 30 kg/m². * No cognitive complaints and normal neurological assessment Patients with idiopathic Parkinson's disease: * Person who has given written consent * Adult * Fasting \> 2 hours before PEG measurement * Body Mass Index (BMI) \< 30 kg/m². * Diagnostic criteria for established or probable IPD Patients with Lewy body disease: * Person who has given written consent * Adult * Fasting \> 2 hours prior to PEG measurement * Body Mass Index (BMI) \< 30 kg/m². * Diagnostic criteria for probable or possible LBD Exclusion Criteria: * Non-affiliated to national health insurance * Person under legal protection (curatorship, guardianship) * Person subject to a court order * Pregnant, parturient or breast-feeding women * Major unable to give consent * MMSE score \< 15 and/or MoCA \< 10 * Known infection with COVID-19 in the 6 months prior to inclusion * Active smoker (\> 4 cigarettes per day on a regular basis) * Subject with pacemaker (contraindication for bioelectrical impedancemetry) * Diabetic (type 1 or type 2) * Taking medication (in progress at the time of the study) that interferes with gustation **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** vincent.schneider@chu-dijon.fr **Name:** Vincent SCHNEIDER **Phone:** 03.80.29.30.89 **Role:** CONTACT #### Locations **Location 1:** **City:** Dijon **Contacts:** ***Contact 1:*** - **Email:** vincent.schneider@chu-dijon.fr - **Name:** Vincent SCHNEIDER - **Phone:** 03.80.29.30.89 - **Role:** CONTACT **Country:** France **Facility:** Chu Dijon Bourgogne ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020734 - Term: Parkinsonian Disorders - ID: D000001480 - Term: Basal Ganglia Diseases - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009069 - Term: Movement Disorders - ID: D000080874 - Term: Synucleinopathies - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000003704 - Term: Dementia - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M13213 - Name: Parkinson Disease - Relevance: HIGH - As Found: Idiopathic Parkinson's Disease - ID: M22693 - Name: Lewy Body Disease - Relevance: HIGH - As Found: Lewy Body Disease - ID: M22494 - Name: Parkinsonian Disorders - Relevance: LOW - As Found: Unknown - ID: M25603 - Name: Ganglion Cysts - Relevance: LOW - As Found: Unknown - ID: M16358 - Name: Synovial Cyst - Relevance: LOW - As Found: Unknown - ID: M4774 - Name: Basal Ganglia Diseases - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12029 - Name: Movement Disorders - Relevance: LOW - As Found: Unknown - ID: M2217 - Name: Synucleinopathies - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M6904 - Name: Dementia - Relevance: LOW - As Found: Unknown - ID: M21836 - Name: Neurocognitive Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010300 - Term: Parkinson Disease - ID: D000020961 - Term: Lewy Body Disease ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06439342 **Brief Title:** A Study of Maribavir in Chinese Adults With Cytomegalovirus (CMV) Infections **Official Title:** An Open-label, Single-arm Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Maribavir in Chinese Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Cidofovir or Foscarnet #### Organization Study ID Info **ID:** TAK-620-3002 #### Organization **Class:** INDUSTRY **Full Name:** Takeda ### Status Module #### Completion Date **Date:** 2027-02-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-06 **Type:** ESTIMATED **Last Update Submit Date:** 2024-06-05 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-02-05 **Type:** ESTIMATED #### Start Date **Date:** 2025-03-14 **Type:** ESTIMATED **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-03 **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:** 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:** The main aim of this study is to learn how safe maribavir is in Chinese adults who have undergone hematopoietic stem cell or organ transplantation and have a cytomegalovirus (CMV) infection and how well they tolerate treatment with maribavir. Other aims are to see how effective maribavir is in treating CMV infection and getting rid of the symptoms, the recurrence rate of CMV infection after treatment with maribavir and if the treatment is required again. Researchers will also check for changes (mutations) occurring in the virus which may cause treatment with maribavir to no longer work well or to not work at all (resistance to maribavir). The participants will be treated with maribavir for 8 weeks. During the study, participants will visit their study clinic 18 times. ### Conditions Module **Conditions:** - Cytomegalovirus (CMV) ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive maribavir 400 milligrams (mg), tablets, orally twice a day (BID) for up to 8 weeks. **Intervention Names:** - Drug: Maribavir **Label:** Maribavir **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Maribavir **Description:** Maribavir tablets **Name:** Maribavir **Other Names:** - TAK-620 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** TEAEs will be defined as those with a start date on or after the first dose of study treatment, or with a start date before the date of first dose of study treatment but increasing in severity after the first dose of study treatment. An SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above-mentioned criteria. AESIs is defined as any adverse event of special interest. **Measure:** Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAE), and Adverse Events of Special interest (AESIs) **Time Frame:** From first dose of study drug up to Week 20 **Description:** Vital signs will include temperature, arterial blood pressure (systolic and diastolic) and pulse. Any change in vital signs assessments which will be deemed clinically significant by the investigator will be reported. **Measure:** Number of Participants With Clinically Significant Changes in Vital Signs **Time Frame:** From first dose of study drug up to Week 20 **Description:** Clinical laboratory parameters will include chemistry, hematology, and urinalysis. Any clinical laboratory abnormalities which will be deemed clinically significant by the investigator will be recorded. **Measure:** Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters **Time Frame:** From first dose of study drug up to Week 20 **Description:** 12-lead ECG will be evaluated. Any ECG assessments which will be deemed clinically significant by the investigator will be reported. **Measure:** Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings **Time Frame:** From first dose of study drug up to Week 20 **Description:** Participants discontinuing the study drug treatment and the study will be reported. **Measure:** Number of Participants Who will Discontinue From the Study Drug and Study **Time Frame:** From first dose of study drug up to Week 20 #### Secondary Outcomes **Description:** Confirmed CMV viremia clearance is defined as plasma CMV DNA concentration below the lower limit of quantification (\<LLOQ), when assessed by CMV Test (Roche COBAS CMV 6800/8800) at a central specialty laboratory, in 2 consecutive postbaseline samples, separated by at least 5 days, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy. **Measure:** Percentage of Participants With Confirmed Clearance of Plasma CMV Deoxyribose Nucleic Acid (DNA) (CMV Viremia Clearance) at Week 8 **Time Frame:** At Week 8 **Description:** Confirmed CMV viremia clearance is defined as plasma CMV DNA concentration below the lower limit of quantification (\<LLOQ), when assessed by CMV Test (Roche COBAS CMV 6800/8800) at a central specialty laboratory, in 2 consecutive postbaseline samples, separated by at least 5 days, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy. Symptom control is defined as resolution or improvement of tissue invasive CMV disease or CMV syndrome for participants symptomatic at baseline or no new symptoms of tissue invasive CMV disease or CMV syndrome for participants asymptomatic at baseline. This outcome measure will be assessed regardless of whether participants complete the stipulated 8 weeks of study-assigned treatment. **Measure:** Percentage of Participants With Achievement of CMV Viremia Clearance and CMV Infection Symptom Control at Weeks 8, 12, 16, and 20 **Time Frame:** At Weeks 8, 12, 16 and 20 **Description:** Confirmed CMV viremia clearance will be defined as plasma CMV DNA concentration \<LLOQ, when assessed by CMV Test (Roche COBAS CMV 6800/8800) at a central specialty laboratory, in 2 consecutive postbaseline samples, separated by at least 5 days (after completion of 8 weeks therapy). Symptom control is defined as resolution or improvement of tissue invasive CMV disease or CMV syndrome for participants symptomatic at baseline or no new symptoms of tissue invasive CMV disease or CMV syndrome for participants asymptomatic at baseline. **Measure:** Percentage of Participants With Achievement of CMV Viremia Clearance and CMV Infection Symptom Control at Week 8 (After Completion of 8 Weeks Therapy) **Time Frame:** At Week 8 **Description:** Confirmed CMV viremia clearance will be defined as plasma CMV DNA concentration \<LLOQ, when assessed by CMV Test (Roche COBAS CMV 6800/8800) at a central specialty laboratory, in 2 consecutive postbaseline samples, separated by at least 5 days (after completion of 8 weeks therapy). Symptom control is defined as resolution or improvement of tissue invasive CMV disease or CMV syndrome for participants symptomatic at baseline or no new symptoms of tissue invasive CMV disease or CMV syndrome for participants asymptomatic at baseline. The maintenance of treatment effect will be based on the achievement of CMV viremia clearance and symptom control at Week 8 after completion of 8 weeks therapy, followed by maintenance of this treatment effect through Weeks 12, 16 and 20. **Measure:** Percentage of Participants With Achievement of CMV Viremia Clearance and CMV Infection Symptom Control After Completion of 8 weeks Therapy Followed by Maintenance of This Treatment Effect Through Weeks 12, 16 and 20 **Time Frame:** At Weeks 12, 16 and 20 **Description:** Recurrence of CMV viremia is defined as plasma CMV DNA concentrations greater than or equal to (\>=) LLOQ, when assessed by central specialty laboratory, in 2 consecutive plasma samples separated by at least 5 days after achieving confirmed viremia clearance. **Measure:** Percentage of Participants With Recurrence of CMV Viremia During the First 8 Weeks and Through Week 12 to Week 20 **Time Frame:** From first dose of study drug up to Week 8, and through Week 12 to Week 20 **Description:** Recurrence of CMV viremia is defined as plasma CMV DNA concentrations \>= LLOQ, when assessed by central specialty laboratory, in 2 consecutive plasma samples separated by at least 5 days after achieving confirmed viremia clearance. On treatment is the period over which participant received actual dosing (that can be before the stipulated 8 weeks of study-assigned treatment). Off treatment is the period after study treatment. **Measure:** Percentage of Participants With Recurrence of CMV Viremia During on Treatment and off Treatment **Time Frame:** From first dose of study drug up to Week 8 (on treatment) and Week 20 (off treatment) **Description:** Recurrence of CMV viremia is defined as plasma CMV DNA concentrations \>=LLOQ, when assessed by central specialty laboratory, in 2 consecutive plasma samples separated by at least 5 days after achieving confirmed viremia clearance. **Measure:** Percentage of Participants With Recurrence of CMV Viremia Requiring Alternative Treatment After Achieving CMV Viremia Clearance at Study Week 8 **Time Frame:** At Week 8 **Description:** Percentage of participants with mutations in the CMV genes conferring resistance to maribavir will be reported. **Measure:** Percentage of Participants With Mutations in the CMV Genes Conferring Resistance to Maribavir **Time Frame:** Up to Week 20 **Description:** All-cause mortality during the study will be reported. **Measure:** Number of Participants With All-cause Mortality During the Study **Time Frame:** Up to Week 20 **Description:** Cmax at steady state for maribavir will be assessed. **Measure:** Maximum Observed Plasma Concentration (Cmax) at Steady State for Maribavir **Time Frame:** Week 1, Day 7: Pre-dose, 0.5, 1.5, 3, 4, 6, 8, and 12 hours post-dose **Description:** Tmax at steady state of maribavir will be assessed. **Measure:** Time to Reach Cmax (Tmax) at Steady State for Maribavir **Time Frame:** Week 1, Day 7: Pre-dose, 0.5, 1.5, 3, 4, 6, 8 and 12 hours post-dose **Description:** Cmin of maribavir will be assessed. **Measure:** Minimum Observed Plasma Concentration (Cmin) for Maribavir **Time Frame:** Pre-dose and at Weeks 1, 4, and 8 **Description:** AUC0-t at steady state for maribavir will be assessed. **Measure:** Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Concentration Area (AUC0-t) at Steady State for Maribavir **Time Frame:** Week 1, Day 7: Pre-dose, 0.5, 1.5, 3, 4, 6, 8 and 12 hours post-dose **Description:** AUC0-tau at steady state for maribavir will be assessed. **Measure:** Area Under the Plasma Concentration-Time Curve Over 1 Dosing Interval of 12 Hours (AUC0-tau) at Steady State for Maribavir **Time Frame:** Week 1, Day 7: Pre-dose, 0.5, 1.5, 3, 4, 6, 8 and 12 hours post-dose **Description:** t1/2 at steady state for maribavir will be assessed. **Measure:** Half -life (t1/2) at Steady State for Maribavir **Time Frame:** Week 1, Day 7: Pre-dose, 0.5, 1.5, 3, 4, 6, 8 and 12 hours post-dose **Description:** Lambda z at steady state for maribavir will be assessed. **Measure:** Terminal Elimination Rate Constant (Lambda z) at Steady State for Maribavir **Time Frame:** Week 1, Day 7: Pre-dose, 0.5, 1.5, 3, 4, 6, 8 and 12 hours post-dose **Description:** Vz/F at steady state for maribavir will be assessed. **Measure:** Apparent Volume of Distribution (Vz/F) at Steady State for Maribavir **Time Frame:** Week 1, Day 7: Pre-dose, 0.5, 1.5, 3, 4, 6, 8 and 12 hours post-dose **Description:** CL/F at steady state for maribavir will be assessed. **Measure:** Apparent Oral Clearance (CL/F) at Steady State for Maribavir **Time Frame:** Week 1, Day 7: Pre-dose, 0.5, 1.5, 3, 4, 6, 8 and 12 hours post-dose ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria * The participant or the participant's legally acceptable representative is willing and able to understand and fully comply with study procedures and requirements, in the opinion of the investigator. * The participant/participant's legally representative has provided informed consent (that is, in writing, documented via a signed and dated informed consent form \[ICF\]) and any required privacy authorization prior to the initiation of any study procedures. * The participant is aged 18 years or older (ie, greater than or equal to \[\>=\] 18 years) at the time of signing the ICF. * The participant must be of Chinese descent, defined as born in China and having Chinese parents and Chinese maternal and paternal grandparents. * The participant must be a recipient of hematopoietic stem cell or solid organ transplant. * The participant must have a documented CMV infection in whole blood or plasma, with a screening value of \>=1,365 International unit per milliliter IU/mL in whole blood or \>=455 IU/mL in plasma in 2 consecutive assessments, separated by at least 1 day, as determined by local laboratory quantitative polymerase chain reaction (qPCR) or comparable quantitative CMV DNA results. Both samples should be taken within 14 days prior to receiving the investigational product with second sample obtained within 5 days prior to receiving the investigational product. The same laboratory and same sample type (whole blood or plasma) must be used for these assessments. * The participant must have a current CMV infection that is refractory to the most recently administered of the 4 anti-CMV treatment agent(s) eg, intravenous (IV) ganciclovir/oral valganciclovir, IV foscarnet, or IV cidofovir. Refractory is defined as documented failure to achieve greater than (\>) 1 log10 (common logarithm to base 10) decrease in CMV DNA level in whole blood or plasma after a 14 day or longer treatment period with the above 4 agents. * Participants who have documentation of 1 or more CMV genetic mutations associated with resistance to ganciclovir/valganciclovir, cidofovir, or foscarnet must also meet the definition of refractory CMV infection. * Have all the following results as part of screening laboratory assessments: * Absolute neutrophil count \>=1000 per cubic millimeter (/mm\^3) (1\*10\^9 per liter \[/L\]). * Platelet count \>= 25,000/mm\^3 (25\*10\^9/L) * Hemoglobin \>= 8 grams per deciliter (g/dL) * Estimated glomerular filtration rate \>= 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) as assessed by Modification of Diet in Renal Disease (MDRD) formula. * The participant must have life expectancy of at least 8 weeks. * The participant has a body weight of at least 35 kilogram (kg). * The female participant either be of nonchildbearing potential, or if of childbearing potential then have a negative serum human chorionic gonadotropin (hCG) or beta-hCG (β-hCG) pregnancy test at screening. Males, or nonpregnant, nonlactating female participants who are sexually active must agree to comply with the applicable contraceptive requirements of this protocol during the investigational product administration period and for 90 days after the last dose of investigational product. * The participant must be able to swallow tablets, or receive tablets crushed and/or dispersed in water via a nasogastric or orogastric tube. Exclusion Criteria: * The participant has CMV disease with central nervous system (CNS involvement) (eg, CMV encephalitis) or ophthalmic involvement (eg, CMV retinitis) as assessed by the investigator at the time of screening. * That participant has uncontrolled other type of infection as assessed by the investigator on the date of treatment assignment. * The participant has a history of clinically relevant alcohol or drug abuse that may interfere with treatment compliance or assessments with the protocol as determined by the investigator. * The participant has a known hypersensitivity to maribavir or to any excipients. * The participant has severe vomiting, diarrhea, or other severe gastrointestinal (GI) illness within 24 hours prior to the first dose of investigational product or a GI absorption abnormality that would preclude administration of oral medication. * The participant has any clinically significant medical or surgical condition that, in the investigator's opinion, could interfere with interpretation of study results, contraindicate the administration of the investigational product, or compromise the safety or well-being of the participant. * The participant is receiving valganciclovir, ganciclovir, cidofovir, foscarnet, letermovir, leflunomide, or artesunate when investigational product is initiated, or anticipated to require one of these agents during the 8-week treatment period. * The participant requires mechanical ventilation or vasopressors for hemodynamic support at the time of baseline. * The participant has previously received maribavir. * The participant has previously completed, discontinued, or have been withdrawn from this study. * The participant has received any investigational agent with known anti-CMV activity within 30 days before initiation of investigational product or CMV vaccine at any time. * The participant has received any investigational agent or device within 30 days before initiation of investigational product. * The participant has serum aspartate aminotransferase (AST) \>5 times upper limit of normal (ULN) at screening, or serum alanine aminotransferase (ALT) \>5 times ULN at screening, or total bilirubin \>=3.0 × ULN at screening (except for documented Gilbert's syndrome), by a local laboratory. Note: Participants with biopsy confirmed CMV hepatitis will not be excluded from study participation despite AST or ALT \>5 times ULN at screening. * The participant has known (previously documented) positive results for human immunodeficiency virus (HIV). Participant must have a confirmed negative HIV test result within 3 months of study entry or, if unavailable, be tested by a local laboratory during the screening period. * The participant has active malignancy with the exception of nonmelanoma skin cancer, as determined by the investigator. Participants who experience relapse or progression of their underlying malignancy (for which hematopoietic stem-cell transplantation (HSCT) or solid organ transplant (SOT) was performed), as determined by the investigator, are not to be enrolled. * The participant is undergoing treatment for acute or chronic hepatitis C and hepatitis B. * The participant is pregnant or expecting to conceive or nursing/breastfeeding. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** medinfoUS@takeda.com **Name:** Takeda Contact **Phone:** +1-877-825-3327 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** sunyuqian83@hotmail.com - **Name:** Site Contact - **Phone:** +86 137 1783 3825 - **Role:** CONTACT ***Contact 2:*** - **Name:** Yuqian Sun, Dr - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** Peking University People's Hospital **State:** North China **Zip:** 100044 #### 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/ ### References Module #### See Also Links **Label:** To obtain more information about this study, click this link **URL:** https://clinicaltrials.takeda.com/study-detail/912adfb97a4a4dae??page=1&idFilter=TAK-620-3002 ## 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: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M6791 - Name: Cytomegalovirus Infections - Relevance: HIGH - As Found: Cytomegalovirus (CMV) - 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 (CMV) ### Condition Browse Module - Meshes - ID: D000003586 - Term: Cytomegalovirus Infections ### Intervention Browse Module - Ancestors - ID: D000000998 - Term: Antiviral 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: M349332 - Name: Maribavir - Relevance: HIGH - As Found: Primary healthcare - ID: M18331 - Name: Ganciclovir - Relevance: LOW - As Found: Unknown - ID: M340476 - Name: Ganciclovir triphosphate - Relevance: LOW - As Found: Unknown - ID: M1840 - Name: Valganciclovir - Relevance: LOW - As Found: Unknown - ID: M1785 - Name: Cidofovir - Relevance: LOW - As Found: Unknown - ID: M19543 - Name: Foscarnet - Relevance: LOW - As Found: Unknown - ID: M13647 - Name: Phosphonoacetic Acid - 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: C000400401 - Term: Maribavir ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06439329 **Brief Title:** STOP (Shared Decision Making to Treat Or Prevent) HIV in Justice Populations **Official Title:** STOP (Shared Decision Making to Treat Or Prevent) HIV in Justice Populations #### Organization Study ID Info **ID:** 2000037052 #### Organization **Class:** OTHER **Full Name:** Yale University #### Secondary ID Infos **ID:** 1R61DA060625-01 **Link:** https://reporter.nih.gov/quickSearch/1R61DA060625-01 **Type:** NIH ### Status Module #### Completion Date **Date:** 2025-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-28 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institute on Drug Abuse (NIDA) #### Lead Sponsor **Class:** OTHER **Name:** Yale University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP/ART and substance use/substance use disorder (SU/SUD) treatment. A standardized Patient Navigation (PN) arm will be compared with a shared decision-making model in the form of Patient Choice (PC) through the offer of a menu of existing community-based health service delivery options. This design will offer providers, correctional and public health authorities, payers and policy makers' timely and relevant data to assess the effectiveness of Patient Navigation and Patient Choice models of care as potentially useful re-entry and relapse prevention treatment options. **Detailed Description:** This study will be done in two phases. Phase 1 the R61 portion of the project will be a Pilot Study, and Phase 2 the R33 portion of the project will be a Randomized Controlled Trail informed by the pilot. The focus of this registration is the pilot study. In Year 1 (R61; Aim 1) the intervention of the patient choice menu of options of PrEP/ART and SUD treatment services for justice involved people who use drugs (PWUD) to supplement established peer navigation (PN +PC) will be developed and pilot tested in Western Connecticut only (Fairfield, Litchfield, Southern New Haven Counties). Implementation procedures for this study include needs assessment survey and focus groups consisting of CAB members and PNs to assess the types of services available in their community, as well as gaps in services and ideas of how services can be improved. These needs assessment surveys and focus groups will occur 3 times throughout the study. ### Conditions Module **Conditions:** - Substance Use Disorders ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** PNs are "near-peer" professionals who have shared lived experiences with participants and help them overcome barriers to accessing and engaging in quality care. PNs are trained and linked to PrEP/ART and SUD services. This manualized PN approach provides appointment scheduling to brick and mortar services only, and not to MHU or telehealth services. **Intervention Names:** - Behavioral: Standard PN **Label:** Standard Patient Navigation (PN) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** PNs working in the PN + PC arm will be trained to engage participants in selecting from the menu of options developed in the pilot. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our CAB. **Intervention Names:** - Behavioral: Standard PN - Behavioral: Patient Choice **Label:** PN + Patient Choice (PC) (PN+PC) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - PN + Patient Choice (PC) (PN+PC) - Standard Patient Navigation (PN) **Description:** Standard of care **Name:** Standard PN **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - PN + Patient Choice (PC) (PN+PC) **Description:** Participants can select from a menu of options including brick and mortar services, Mobile Health Unit (MHU) or telehealth services. **Name:** Patient Choice **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Attitudes toward acceptability and feasibility of the PN and PN+PC menu of options will be surveyed from CAB members using the needs assessment created during project ACTION as a foundation. **Measure:** Feasibility/acceptability will be assessed using the CAB Community Needs Assessment **Time Frame:** 3 months **Description:** Organizational readiness for implementing change (ORIC) will be surveyed at start of preparation and sustainment phases with CAB members to evaluate confidence and commitment to using the PN+PC approach. **Measure:** Feasibility/acceptability will be assessed using the Organizational Readiness for Implementing Change (ORIC) from the JCOIN Common Measure survey **Time Frame:** 3 months **Description:** Participant attitudes toward the PN and PN+PC implementation approach (rapport, satisfaction, linkage to services, engagement) will be collected at 3 months using the Scales for Participant Alliance with Recovery Coach; SPARC. The SPARC is scored on a Likert scale (1 = strongly disagree to 5 = strongly agree), higher scores indicate a high perception of the recovery coach alliance. There are six domains (engagement, satisfaction, rapport, motivation and encouragement, role model, and community linkage), and each domain score is between 10 and 50. **Measure:** Participant attitudes toward the interventions will be assessed using the Scales for Participant Alliance with Recovery Coach (SPARC) **Time Frame:** 3 months **Description:** Utilization of Services and PN Engagement data will be used to assess the percentage of participants with access to PrEP/ART services. **Measure:** Percentage of participants with access to PrEP/ART services **Time Frame:** 3 months **Description:** Defined as participants that have received a prescription for PrEP/ART **Measure:** Percentage of participants with receipt of treatment **Time Frame:** 3 months #### Secondary Outcomes **Description:** Percentage of participants engaged in substance use disorder (SUD) treatment **Measure:** Substance use treatment **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * able to provide written informed consent in English or Spanish; * living in the community of Western, CT, Dallas and Tarrant Counties in TX and Madison County, KY (potential for Fayette county as well); * Those with current justice involvement (with in the past 6 months) (e.g., prison, jail, community supervision); * willing to have HIV testing to determine negative or positive status; * persons with HIV who report not currently taking ART and have a viral load \>200 copies/mL in past 6 months OR persons who test negative for HIV who report not taking PrEP that meet CDC PrEP eligibility criteria in past 6 months, including (i) condomless sexual intercourse; and/or (ii) sharing IDU equipment with HIV positive or unknown status partner; and/or (iii) bacterial STI and; * have a current DSM-5 SUD (opioid and/or stimulant). Implementation portion/CAB members: * able to provide written informed consent in English or Spanish; * working with persons with a history of justice involvement and substance use in the areas targeted for this project PN Participants: * able to provide written informed consent in English or Spanish; * be employed at a project research site as a Patient Navigator Exclusion Criteria: * severe medical or psychiatric disability making participation unsafe; * unable to provide consent. * persons self-reporting pregnancy Implementation portion/CAB members: * persons self-reporting pregnancy **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Sandra.springer@yale.edu **Name:** Sandra Springer, MD **Phone:** 203-687-6680 **Role:** CONTACT **Contact 2:** **Email:** Cyndi.frank@yale.edu **Name:** Cynthia Frank, PhD, RN **Phone:** 203-745-8630 **Role:** CONTACT #### Locations **Location 1:** **City:** New Haven **Country:** United States **Facility:** 135 College St., Suite 280 **State:** Connecticut **Zip:** 06510 #### Overall Officials **Official 1:** **Affiliation:** Yale School of Medicine **Name:** Sandra Springer, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000064419 - Term: Chemically-Induced Disorders - 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: BC25 - Name: Substance Related Disorders - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M18250 - Name: HIV Infections - Relevance: LOW - As Found: Unknown - ID: M3522 - Name: Acquired Immunodeficiency Syndrome - Relevance: LOW - As Found: Unknown - ID: M21837 - Name: Substance-Related Disorders - Relevance: HIGH - As Found: Substance Use Disorders - ID: M30302 - Name: Chemically-Induced Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000019966 - Term: Substance-Related Disorders ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06439316 **Brief Title:** Physical Function and Mental Health in Cancer Survivors **Official Title:** Joint Association Between Sedentary Behavior and Depressive Symptoms With Mortality Outcomes Among Cancer Survivors #### Organization Study ID Info **ID:** #2011-18 #### Organization **Class:** OTHER **Full Name:** West China Hospital ### Status Module #### Completion Date **Date:** 2018-12-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2018-12-31 **Type:** ACTUAL #### Start Date **Date:** 2007-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **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:** West China Hospital #### Responsible Party **Investigator Affiliation:** West China Hospital **Investigator Full Name:** Lei Liu **Investigator Title:** Director **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this observational study is to evaluate the joint prognostic effects of physical function and mental health on survival of cancer survivors. **Detailed Description:** Cancer survivors were selected from the National Health and Nutrition Examination Survey (NHANES) between 2007 and 2018. Total sedentary time was assessed by self-reported daily hours of sitting and depressive symptoms were assessed by Patient Health Questionnaire 9 (PHQ-9). Kaplan-Meier (KM) curves and the Cox regression analyses were used to evaluate the separate and joint prognostic effects of sedentary behavior and depressive symptoms with mortality outcomes of cancer survivors. ### Conditions Module **Conditions:** - Cancer - Sedentary Behavior - Depressive Symptoms - Survivorship ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 2932 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Total sedentary time was assessed by self-reported daily hours of sitting **Name:** Sedentary behavior **Type:** BEHAVIORAL #### Intervention 2 **Description:** depressive symptoms were assessed by Patient Health Questionnaire 9 scale **Name:** Depressive symptoms **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Joint association between sedentary behavior and depressive symptoms with all-cause mortality of cancer survivors **Measure:** All-cause mortality of cancer survivors **Time Frame:** Jan 1, 2007 to 31 Dec, 2019 **Description:** Joint association between sedentary behavior and depressive symptoms with cancer mortality of cancer survivors **Measure:** Cancer mortality of cancer survivors **Time Frame:** Jan 1, 2007 to 31 Dec, 2019 **Description:** Joint association between sedentary behavior and depressive symptoms with non-cancer mortality of cancer survivors **Measure:** Non-cancer mortality of cancer survivors **Time Frame:** Jan 1, 2007 to 31 Dec, 2019 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults with aged above 18 year old Exclusion Criteria: * Without a history of cancers * Without records of sedentary behavior or depressive symptoms test * Incomplete follow-up information **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Cancer survivors were selected from the National Health and Nutrition Examination Survey (NHANES) program between 2007 and 2018. ## 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: Depressive Symptoms - 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:** NCT06439303 **Brief Title:** Analysis and Evaluation of Smoking Treatment With Cytisine **Official Title:** Analysis and Evaluation of Smoking Treatment With Cytisine: Retrospective Observational Study #### Organization Study ID Info **ID:** RS104/IRE/24 #### Organization **Class:** OTHER **Full Name:** Regina Elena Cancer Institute ### Status Module #### Completion Date **Date:** 2024-06-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-20 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Regina Elena Cancer Institute #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The lack of clinical studies on the use of Cytisine in the treatment of the cessation of smoking, the need to find effective therapeutic alternatives and the opportunity to reduce costs related to the complications of cigarette smoking, represent the main reasons that led to the design of this study. **Detailed Description:** The study is observational, retrospective and monocentric, and aims to evaluate patients who performed an initial pneumological examination at the Anti-Smoking Center of the National Institute Regina Elena tumors due to smoking cessation in the reference period. To such patients, affected of moderate or severe tobacco use disorder, drug therapy was prescribed with Cytisine 1.5 mg, with the aim of evaluating treatment adherence, efficacy and tolerability of Cytisine as monotherapy in the treatment of moderate or moderate tobacco use disorder serious. Responding patients will be taken into consideration for the study consecutively to the criteria established and pertaining to the Anti-Smoking Center of the National Cancer Institute Regina Elena in the period between 02/01/2023 and 11/30/2023 on first and subsequent visits controls. ### Conditions Module **Conditions:** - Moderate or Severe Tobacco Use Disorder ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 65 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients hospitalized at the IRE anti-smoking center, National Cancer Institute "Regina Elena", suffering from moderate or severe tobacco use disorder, who are prescribed pharmacological therapy with Cytisine 1.5 mg. **Intervention Names:** - Drug: Cytisine 1,5 mg **Label:** Patients with moderate or severe tobacco use disorder. ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients with moderate or severe tobacco use disorder. **Description:** Administration of Cytisine as monotherapy in the treatment of moderate tobacco use disorder or serious **Name:** Cytisine 1,5 mg **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Evaluation of adherence to the prescribed drug therapy i.e. Cytisine 1.5 mg **Measure:** Therapeutic adherence **Time Frame:** 3 months #### Secondary Outcomes **Description:** Evaluation of the effectiveness of the therapy with the achievement of smoking cessation subsequent checks occurred after clinical evaluation and measurement of the monoxide value exhaled carbon. **Measure:** Evaluation of the effectiveness of the therapy. **Time Frame:** 3 months **Description:** Evaluation of adherence to Cytisine therapy in relation to the patient's motivation measured with the Mondor motivational test. **Measure:** Evaluation of therapeutic adherence in relation to motivation. **Time Frame:** 3 months **Description:** Evaluation of adherence to Cytisine therapy in relation to the addiction score physical measured with the Nicotine dependence questionnaire or Fagerström test. **Measure:** Assessment of adherence in relation to the dependency score physics. **Time Frame:** 3 months **Description:** Safety and Tolerability assessment describing any adverse reactions related to the intake of Cytisine. **Measure:** Safety and Tolerability assessment. **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients aged \> 18 years; * patients suffering from moderate or severe tobacco use disorder; * prescription of pharmacological therapy with Cytisine; * patients returned to the 1st check-up on schedule; Exclusion Criteria: * Patients with contraindications to taking Cytisine and partial receptor agonists nicotinic cholinergics; * Patients undergoing pharmacological or physical treatment for neoplastic pathology; * Pregnant or breastfeeding women; * Patients for whom specific information for objective assessments is not available; **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients who have referred to the Anti-smoking Center of the IRE, National Cancer Institute "Regina Elena", and that meet the following criteria. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** maria.papale@ifo.it **Name:** Maria Papale, Doctor **Phone:** 0652666903 **Phone Ext:** +39 **Role:** CONTACT #### Locations **Location 1:** **City:** Rome **Contacts:** ***Contact 1:*** - **Email:** maria.papale@ifo.it - **Name:** Maria Papale, Doctor - **Phone:** 0652666903 - **Phone Ext:** +39 - **Role:** CONTACT **Country:** Italy **Facility:** "Regina Elena" National Cancer Institute **Status:** RECRUITING **Zip:** 00144 ## Derived Section ### Condition Browse Module - Ancestors - 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: M16785 - Name: Tobacco Use Disorder - Relevance: HIGH - As Found: Tobacco Use Disorder - 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: D000014029 - Term: Tobacco Use Disorder ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06439290 **Brief Title:** Voice Outcome of Glottoplasty, Cricothyroid Approximation, Thyroplasty, and Chondrolaryngoplasty **Official Title:** Voice Outcome of Glottoplasty, Cricothyroid Approximation, Thyroplasty, and Chondrolaryngoplasty #### Organization Study ID Info **ID:** ONZ-2024-0049/ONZ-2024-0081 #### Organization **Class:** OTHER **Full Name:** University Ghent ### Status Module #### Completion Date **Date:** 2027-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-30 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-10 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Ghent #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to measure the short- and long-term voice outcome and outcome predictors of glottoplasty, cricothyroid approximation, thyroplasty, and chondrolaryngoplasty using a prospective non-randomized controlled trial and a multidimensional voice assessment protocol. Secondly, a laryngeal magnetic resonance imaging protocol will be developed to measure pre- and postoperative anatomical factors and compare them with the acoustic changes. **Detailed Description:** Gender-affirming voice surgery (such as glottoplasty, cricothyroid approximation, thyroplasty and chondrolaryngoplasty), in addition to gender-affirming voice training and hormone therapy, plays an important role in achieving a gender-congruent voice in transgender and gender diverse people. In addition, these interventions are sometimes performed on cisgender men or women who wish to change their voice. However, the impact of these interventions on broad voice characteristics needs to be further investigated. A thyroid chondroplasty is a procedure in which the cartilage of the larynx is flattened to make the larynx ("Adam's apple") less visible. This procedure is sometimes performed in combination with voice surgery. Although clinically in some cases we observe a temporary lowering of the pitch of the voice during thyroid chondroplasty, little is known in the literature about the impact of this surgery on voice characteristics. The first purpose is to measure the effect of glottoplasty, cricothyroid approximation, thyroplasty and/or thyroid chondroplasty on a) acoustic voice characteristics (such as the pitch and resonance of the voice), b) perception of femininity/masculinity, c) psychosocial well-being and satisfaction and d) the function of the vocal folds. Persons undergoing a glottoplasty, cricothyroid approximation, thyroplasty and/or thyroid chondroplasty in the head and neck surgery department are routinely invited to several pre- and postoperative check-up appointments in the head and neck surgery and ear, nose and throat department. These people will be invited to participate in the study in which the data, which are routinely collected preoperatively, 1 week, 1 month, 6 months and 12 months postoperatively during a speech-language pathology (SLP) consultation and a head and neck surgery consultation. These data will be used for scientific research to study the outcome of such surgery on phonation. These pre- and post-operative consultations are clinically standard. During these consultations, a voice assessment and videolaryngostroboscopic examination of the vocal folds are routinely performed. Recordings and images obtained through these studies can be further processed in the context of this scientific research (such as conducting a listening experiment, analyzing (e.g. using the VALI form) and measuring the video laryngostroboscopy results, etc.). Secondly, factors (determinants) that influence the effect of previous surgical interventions will be studied within this research. The third purpose of this study is to develop and validate a laryngeal magnetic resonance imaging (MRI) protocol using a laryngeal surface coil to measure pre- and postoperative anatomical factors (vocal fold length and thickness, thyroarytenoid muscle mass and area) and compare them with the acoustic changes. ### Conditions Module **Conditions:** - Surgery - Larynx - Transgenderism - Gender Dysphoria **Keywords:** - Transgender - Phonosurgery - Determinants - MRI ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Purpose 1: prospective non-randomized controlled trial. Experimental group: persons undergoing phonosurgery Control group: age-matched PFAB/PMAB undergoing mastectomy/breast augmentation Purpose 2: Predictors of the outcome of abovementioned surgery in the experimental group will be determined using correlational research (regression analysis). Purpose 3: After optimization of MRI sequences and testing in healthy participants (n=5), a segmentation and measurement workflow will be completed. Objective measurement of pre- and postoperative laryngeal anatomy: Anatomical outcome measures will be obtained and compared before and one month/6 months after surgery in the experimental group. ##### Masking Info **Masking:** SINGLE **Masking Description:** Assessments will be performed by an ENT specialist and SLP of the research group who is blinded to study evolution and group allocation. **Who Masked:** - CARE_PROVIDER **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 290 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Group undergoing phonosurgery (glottoplasty, cricothyroid approximation, thyroplasty or chondrolaryngoplasty) **Intervention Names:** - Procedure: Phonosurgery **Label:** Experimental group: phonosurgery **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Control group: age matched TGD PFAB/PMAB undergoing mastectomy or breast augmentation surgery with the same in- and exclusion criteria. **Intervention Names:** - Procedure: Mastectomy/breast augmentation **Label:** Control group: other surgery **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental group: phonosurgery **Description:** Gender-affirming voice surgery (such as glottoplasty, cricothyroid approximation, thyroplasty and chondrolaryngoplasty), in addition to gender-affirming voice training and hormone therapy, plays an important role in achieving a gender-congruent voice in transgender and gender diverse people. In addition, these interventions are sometimes performed on cisgender men or women who wish to change their voice. However, the impact of these interventions on broad voice characteristics needs to be further investigated. **Name:** Phonosurgery **Other Names:** - glottoplasty - thyroplasty - cricothyroid approximation - chondrolaryngoplasty **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Control group: other surgery **Description:** Control group of PFAB and PMAB persons undergoing a mastectomy or breast augmentation surgery. **Name:** Mastectomy/breast augmentation **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Speaking fundamental frequency **Measure:** Speaking fo **Time Frame:** pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year) **Description:** Formant frequencies 1-5 **Measure:** FF 1-5 **Time Frame:** pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year) **Description:** Self-perception and listener perceptions of femininity and masculinity. Visual analogue scale (0 = very masculine, 100 = very feminine). **Measure:** Perceptual femininity/masculinity score **Time Frame:** pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year) #### Secondary Outcomes **Description:** Dysphonia Severity Index, cut-off score 1.6 (above 1.6 is normophonic) **Measure:** Vocal capacity **Time Frame:** pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year) **Description:** Voice Range Profile (min-max of fo and intensity (SPL)) **Measure:** Vocal range **Time Frame:** pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year) **Description:** Acoustic Voice Quality Index, cut-off score 2.95 (below 2.95 is normophonic) **Measure:** Vocal quality **Time Frame:** pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year) **Description:** Flexible videolaryngostroboscopy **Measure:** Laryngeal function **Time Frame:** pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year) **Description:** Voice Handicap Index, score from 0-120, the higher the score, the worse. **Measure:** PROMs: Voice Handicap Index **Time Frame:** pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year) **Description:** Trans Woman Voice Questionnaire, score from 1-120, the higher the score, the worse. **Measure:** PROMs: Trans Woman Voice Questionnaire **Time Frame:** pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year) **Description:** Visual analogue scales to measure satisfaction (VAS with 0=strongly disagree, 100=strongly agree). **Measure:** Other PROMs **Time Frame:** pre, post 1 (1 week), post 2 (1 month), post 3 (6 months), post 4 (1 year) ### Eligibility Module **Eligibility Criteria:** PURPOSE 1: Inclusion criteria for surgery participants: * Persons who will soon undergo surgery on the vocal folds and/or larynx (including glottoplasty, cricothyroid approximation, thyroplasty and/or thyroid chondroplasty) at UZ Gent * At least 18 years old * Sufficient command of the Dutch language for understanding the informed consent letter and completing Dutch questionnaires Inclusion criteria for volunteers to provide speech samples: - Cisgender men or women Inclusion criteria for volunteer listeners for the listening experiment: * Dutch-speaking * Self-reported normal hearing PURPOSE 2: same as above. PURPOSE 3: Inclusion criteria for the healthy participants: * At least 18 years old * Sufficient command of the Dutch language to complete a Dutch questionnaire Exclusion criteria for the healthy participants: - One or more contraindications for an MRI examination. These contraindications are checked using a questionnaire (safety checklist). Inclusion criteria for the pre- and postoperative MRI participants: - Random selection of +- 10 participants of purpose 1. Exclusion criteria for the pre- and postoperative MRI participants: - One or more contraindications for an MRI examination. These contraindications are checked using a questionnaire (safety checklist). **Gender Based:** True **Gender Description:** Persons with both a masculine/feminine/nonbinary gender identity **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** evelien.dhaeseleer@ugent.be **Name:** Evelien D'haeseleer, PhD **Phone:** +32 9 332 24 67 **Role:** CONTACT **Contact 2:** **Email:** clara.leyns@ugent.be **Name:** Clara Leyns, PhD **Phone:** +3293320143 **Role:** CONTACT #### Locations **Location 1:** **City:** Ghent **Contacts:** ***Contact 1:*** - **Email:** clara.leyns@ugent.be - **Name:** Clara Leyns, PhD - **Role:** CONTACT **Country:** Belgium **Facility:** Ghent University Hospital **State:** East-Flanders **Status:** RECRUITING **Zip:** 9000 **Location 2:** **City:** Ghent **Contacts:** ***Contact 1:*** - **Email:** clara.leyns@ugent.be - **Name:** Clara Leyns, PhD - **Role:** CONTACT **Country:** Belgium **Facility:** Ghent University **State:** East-Flanders **Status:** RECRUITING **Zip:** 9000 #### Overall Officials **Official 1:** **Affiliation:** University Ghent **Name:** Clara Leyns, PhD **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** University Ghent **Name:** Evelien D'haeseleer, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** University Hospital, Ghent **Name:** Peter Tomassen, PhD, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020018 - Term: Sexual Dysfunctions, Psychological - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases ### Condition Browse Module - Browse Leaves - ID: M227 - Name: Gender Dysphoria - Relevance: HIGH - As Found: Gender Dysphoria - ID: M10835 - Name: Laryngeal Diseases - Relevance: LOW - As Found: Unknown - ID: M21873 - Name: Sexual Dysfunctions, Psychological - 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: D000068116 - Term: Gender Dysphoria ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06439277 **Brief Title:** A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2) **Official Title:** Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo for the Treatment of Obesity and Weight-Related Comorbidities in Adolescents: A Randomized, Double-Blind, Placebo- Controlled Trial (SURMOUNT-ADOLESCENTS-2) #### Organization Study ID Info **ID:** 18832 #### Organization **Class:** INDUSTRY **Full Name:** Eli Lilly and Company #### Secondary ID Infos **Domain:** Eli Lilly and Company **ID:** I8F-MC-GPIX **Type:** OTHER ### Status Module #### Completion Date **Date:** 2027-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **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:** Eli Lilly and Company #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of the study is to assess how tirzepatide impacts bodyweight and cardiovascular risk factors when used in conjunction with healthy nutrition and physical activity in adolescents with obesity and multiple weight related comorbidities. The study will last approximately 76 weeks and may include up to 23 visits. **Detailed Description:** The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity with multiple weight related comorbidities. ### Conditions Module **Conditions:** - Obesity - Weight Gain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive tirzepatide subcutaneously (SC). **Intervention Names:** - Drug: Tirzepatide **Label:** Tirzepatide **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive placebo SC. **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Tirzepatide **Description:** Administered SC **Name:** Tirzepatide **Other Names:** - LY3298176 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Administered SC **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Percent Change from Baseline in Body Mass Index (BMI) **Time Frame:** Baseline, Week 72 **Measure:** A Composite Endpoint of Normalization or Clinically Significant Improvement in At Least 2 Predefined Weight-Related Comorbidities Present at Screening Without Development of New Predefined Comorbidity or Worsening of Existing Predefined Comorbidity **Time Frame:** Baseline, Week 72 #### Secondary Outcomes **Measure:** Percentage of Participants Who Achieve BMI Reduction of ≥ 5% **Time Frame:** Week 72 **Measure:** Percentage of Participants Who Achieve BMI Reduction of ≥ 10% **Time Frame:** Week 72 **Measure:** Percentage of Participants Who Achieve BMI Reduction of ≥ 15% **Time Frame:** Week 72 **Measure:** Percentage of Participants Who Achieve BMI Reduction of ≥ 20% **Time Frame:** Week 72 **Measure:** Change from Baseline in Hemoglobin A1c (HbA1c) **Time Frame:** Baseline, Week 72 **Measure:** Percent Change from Baseline in Triglycerides **Time Frame:** Baseline, Week 72 **Measure:** Change from Baseline in Systolic Blood Pressure (SBP) **Time Frame:** Baseline, Week 72 **Measure:** Change from Baseline in Peripheral Apnea-Hypopnea Index (pAHI) **Time Frame:** Baseline, Week 72 **Measure:** Percent Change from Baseline in Total Body Fat Mass as Determined by Dual energy X-ray Absorptiometry (DXA) **Time Frame:** Baseline, Week 72 **Measure:** Change from Baseline in Diastolic Blood Pressure (DBP) **Time Frame:** Baseline, Week 72 **Measure:** Percent Change from Baseline in Body Weight **Time Frame:** Baseline, Week 72 **Measure:** Change from Baseline in Waist Circumference **Time Frame:** Baseline, Week 72 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Have body mass index (BMI) equal to or above the 95th percentile for age and sex (on age and gender-specific growth chart for diagnosis of obesity) with at least 2 of the following predefined weight-related comorbidities: hypertension, prediabetes and hypertriglyceridemia. * Have history of at least 1 self-reported unsuccessful dietary effort to lose weight. * Are capable of giving signed informed consent by a legal representative or assent by a study participant (when applicable). Exclusion Criteria: * Have undergone or plan to undergo a weight reduction procedure during the study, such as, but not limited to * gastric bypass * sleeve gastrectomy * restrictive bariatric surgery, such as Lap-Band gastric banding, or * any other procedure intended to result in weight reduction. * Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records * Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state * Have type 2 diabetes or have a HbA1c \> 6.4% at screening * Have a history of chronic or acute pancreatitis * Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 **Maximum Age:** 17 Years **Minimum Age:** 12 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ClinicalTrials.gov@lilly.com **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:** Los Angeles **Contacts:** ***Contact 1:*** - **Name:** Alaina Vidmar - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Children's Hospital Los Angeles **State:** California **Zip:** 90027 **Location 2:** **City:** Sacramento **Contacts:** ***Contact 1:*** - **Name:** Gnanagurudasan Prakasam - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Center Of Excellence in Diabetes and Endocrinology **State:** California **Zip:** 95821 **Location 3:** **City:** Wilmington **Contacts:** ***Contact 1:*** - **Name:** Chijioke Ikomi - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Nemours Children's Health - Delaware **State:** Delaware **Zip:** 19803 **Location 4:** **City:** Chicago **Contacts:** ***Contact 1:*** - **Name:** Jami Josefson - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Ann & Robert H. Lurie Children's Hospital of Chicago **State:** Illinois **Zip:** 60611 **Location 5:** **City:** Indianapolis **Contacts:** ***Contact 1:*** - **Name:** Tamara Hannon - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Indiana University Health University Hospital **State:** Indiana **Zip:** 46202 **Location 6:** **City:** Buffalo **Contacts:** ***Contact 1:*** - **Name:** Lucy Mastrandrea - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** UBMD Pediatrics **State:** New York **Zip:** 14203 **Location 7:** **City:** Syracuse **Contacts:** ***Contact 1:*** - **Name:** David Hansen - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** SUNY Upstate Medical University **State:** New York **Zip:** 13210 **Location 8:** **City:** Corpus Christi **Contacts:** ***Contact 1:*** - **Name:** Ana Paez - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Driscoll Children's Hospital **State:** Texas **Zip:** 78411 **Location 9:** **City:** Weslaco **Contacts:** ***Contact 1:*** - **Name:** Eduardo Luna - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Texas Valley Clinical Research **State:** Texas **Zip:** 78596 **Location 10:** **City:** Layton **Contacts:** ***Contact 1:*** - **Name:** Peter Silas - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Alliance for Multispecialty Research, LLC **State:** Utah **Zip:** 84041 **Location 11:** **City:** Ciudad Autónoma de Buenos Aires **Contacts:** ***Contact 1:*** - **Name:** Federico Perez Manghi - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Argentina **Facility:** Centro de Investigaciones Metabólicas (CINME) **State:** Buenos Aires **Zip:** 1056 **Location 12:** **City:** Ramos Mejía **Contacts:** ***Contact 1:*** - **Name:** Oscar Montaña - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Argentina **Facility:** DIM Clínica Privada **State:** Buenos Aires **Zip:** B1704ETD **Location 13:** **City:** Buenos Aires **Contacts:** ***Contact 1:*** - **Name:** Blanca Ozuna - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Argentina **Facility:** Investigaciones Medicas Imoba Srl **State:** Ciudad Autónoma De Buenos Aires **Zip:** C1056ABH **Location 14:** **City:** Ciudad Autonoma de Buenos Aires **Contacts:** ***Contact 1:*** - **Name:** Maria Coronel - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Argentina **Facility:** Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada **State:** Ciudad Autónoma De Buenos Aires **Zip:** C1425AGC **Location 15:** **City:** SAN M. DE Tucuman **Contacts:** ***Contact 1:*** - **Name:** Leonardo Serra - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Argentina **Facility:** Centro Medico Privado de Reumatologia **State:** Tucumán **Zip:** T4000AXL **Location 16:** **City:** Buenos Aires **Contacts:** ***Contact 1:*** - **Name:** Agustin Cardoso - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Argentina **Facility:** Fundación Respirar **Zip:** C1426ABP **Location 17:** **City:** Sydney **Contacts:** ***Contact 1:*** - **Name:** Tania Markovic - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Australia **Facility:** University of Sydney - Charles Perkins Centre **State:** New South Wales **Zip:** 2006 **Location 18:** **City:** Coorparoo **Contacts:** ***Contact 1:*** - **Name:** Young Jin Kim - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Australia **Facility:** Cornerstone Dermatology **State:** Queensland **Zip:** 4151 **Location 19:** **City:** Adelaide **Contacts:** ***Contact 1:*** - **Name:** Andrew Hamilton - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Australia **Facility:** Nightingale Research **State:** South Australia **Zip:** 5000 **Location 20:** **City:** Perth **Contacts:** ***Contact 1:*** - **Name:** Jacqueline Curran - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Australia **Facility:** Perth Children's Hospital **State:** Western Australia **Zip:** 6009 **Location 21:** **City:** Calgary **Contacts:** ***Contact 1:*** - **Name:** Josephine Ho - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Canada **Facility:** Alberta Children's Hospital Loc. 1 **State:** Alberta **Zip:** T3B 6A8 **Location 22:** **City:** Hamilton **Contacts:** ***Contact 1:*** - **Name:** Richard Tytus - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Canada **Facility:** Hamilton Medical Research Group **State:** Ontario **Zip:** L8M 1K7 **Location 23:** **City:** Montréal **Contacts:** ***Contact 1:*** - **Name:** Laurent Legault - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Canada **Facility:** McGill University Health Centre **State:** Quebec **Zip:** H4A 3J1 **Location 24:** **City:** Marseille **Contacts:** ***Contact 1:*** - **Name:** Rachel Reynaud - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone **State:** Bouches-du-Rhône **Zip:** 13385 **Location 25:** **City:** Toulouse **Contacts:** ***Contact 1:*** - **Name:** Beatrice Jouret - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** CHU de Toulouse - Hôpital des Enfants **State:** Haute-Garonne **Zip:** 31059 **Location 26:** **City:** Angers **Contacts:** ***Contact 1:*** - **Name:** Regis Coutant - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** Centre Hospitalier Universitaire d'Angers **State:** Maine-et-Loire **Zip:** 49933 **Location 27:** **City:** Lille **Contacts:** ***Contact 1:*** - **Name:** Iva Gueorguieva - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** Hôpital Jeanne de Flandre **State:** Nord-Pas-de-Calais **Zip:** 59000 **Location 28:** **City:** Bron **Contacts:** ***Contact 1:*** - **Name:** Marc Nicolino - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** Hospices Civils de Lyon - Hopital Louis Pradel **State:** Rhône **Zip:** 69677 **Location 29:** **City:** Paris **Contacts:** ***Contact 1:*** - **Name:** Beatrice Dubern - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** Hôpital Armand Trousseau **Zip:** 75012 **Location 30:** **City:** Paris **Contacts:** ***Contact 1:*** - **Name:** Jean-Claude Carel - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T **Zip:** 75019 **Location 31:** **City:** Ulm **Contacts:** ***Contact 1:*** - **Name:** Martin Wabitsch - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Germany **Facility:** Universitaetsklinikum Ulm **State:** Baden-Württemberg **Zip:** 89075 **Location 32:** **City:** Köln **Contacts:** ***Contact 1:*** - **Name:** Miriam Jackels - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Germany **Facility:** Klinik und Poliklinik für Kinder- und Jugendmedizin pädiatrische Endokrinologie und Diabetologie **State:** Nordrhein-Westfalen **Zip:** 50937 **Location 33:** **City:** Leipzig **Contacts:** ***Contact 1:*** - **Name:** Antje Körner - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Germany **Facility:** Universitätsklinikum Leipzig **State:** Sachsen **Zip:** 04103 **Location 34:** **City:** Be'er Sheva **Contacts:** ***Contact 1:*** - **Name:** Alon Haim - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Israel **Facility:** Soroka Medical Center **State:** HaDarom **Zip:** 8410101 **Location 35:** **City:** Beer Yaacov **Contacts:** ***Contact 1:*** - **Name:** Marianna Rachmiel - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Israel **Facility:** Yitzhak Shamir Medical Center **State:** HaMerkaz **Zip:** 70300 **Location 36:** **City:** Kfar Saba **Contacts:** ***Contact 1:*** - **Name:** Victor Vishlitzky - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Israel **Facility:** Meir Medical Center **State:** HaMerkaz **Zip:** 4428164 **Location 37:** **City:** Petah-Tikva **Contacts:** ***Contact 1:*** - **Name:** Moshe Phillip - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Israel **Facility:** Schneider Children's Medical Center **State:** HaMerkaz **Zip:** 4920235 **Location 38:** **City:** Ramat Gan **Contacts:** ***Contact 1:*** - **Name:** Orit Pinhas-Hamiel - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Israel **Facility:** Sheba Medical Center **State:** HaMerkaz **Zip:** 5262100 **Location 39:** **City:** Afula **Contacts:** ***Contact 1:*** - **Name:** Alina German - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Israel **Facility:** Emek Medical Center **State:** HaTsafon **Zip:** 1834111 **Location 40:** **City:** Haifa **Contacts:** ***Contact 1:*** - **Name:** Ram Weiss - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Israel **Facility:** Rambam Health Care Campus **State:** HaTsafon **Zip:** 3109601 **Location 41:** **City:** Jerusalem **Contacts:** ***Contact 1:*** - **Name:** Floris Levy-Khademi - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Israel **Facility:** Shaare Zedek Medical Center **State:** Yerushalayim **Zip:** 9013102 **Location 42:** **City:** Haifa **Contacts:** ***Contact 1:*** - **Name:** Ilana Zalmon Koren - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Israel **Facility:** Pediatrics Endocrinology **State:** Ḥeifā **Zip:** 3436212 **Location 43:** **City:** Zapopan **Contacts:** ***Contact 1:*** - **Name:** Emilia Pelayo Orozco - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Mexico **Facility:** Centro de Investigacion Medica de Occidente, S.C. **State:** Jalisco **Zip:** 44260 **Location 44:** **City:** Monterrey **Contacts:** ***Contact 1:*** - **Name:** Diego Gaytan-Saracho - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Mexico **Facility:** Christus - Latam Hub Center of Excellence and Innovation S.C. **State:** Nuevo León **Zip:** 64060 **Location 45:** **City:** Monterrey **Contacts:** ***Contact 1:*** - **Name:** Pedro Garcia - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Mexico **Facility:** Clínica García Flores SC **State:** Nuevo León **Zip:** 64610 **Location 46:** **City:** Aguascalientes **Contacts:** ***Contact 1:*** - **Name:** Ricardo Choza Romero - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Mexico **Facility:** Centro de Atención e Investigación Clínica **Zip:** 20129 **Location 47:** **City:** Puebla **Contacts:** ***Contact 1:*** - **Name:** Margarita Barrientos - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Mexico **Facility:** Consultorio Médico de Endocrinología y Pediatría **Zip:** 72190 **Location 48:** **City:** San Juan **Contacts:** ***Contact 1:*** - **Name:** Francisco Nieves-Rivera - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Puerto Rico **Facility:** University Pediatric Hospital **Zip:** 00935 **Location 49:** **City:** Cordoba **Contacts:** ***Contact 1:*** - **Name:** Ana Ariza-Jimenez - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital Universitario Reina Sofia **State:** Andalucía **Zip:** 14004 **Location 50:** **City:** Barcelona **Contacts:** ***Contact 1:*** - **Name:** ANDREEA CIUDIN - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital Universitari Vall d'Hebron **State:** Barcelona [Barcelona] **Zip:** 08035 **Location 51:** **City:** Madrid **Contacts:** ***Contact 1:*** - **Name:** Gabriel Martos-Moreno - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital Infantil Universitario Niño Jesús **State:** Madrid, Comunidad De **Zip:** 28009 **Location 52:** **City:** Málaga **Contacts:** ***Contact 1:*** - **Name:** Isabel Leiva - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital Regional Universitario **Zip:** 29011 **Location 53:** **City:** València **Contacts:** ***Contact 1:*** - **Name:** María Francisca Moreno Macián - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Hospital Universitari i Politecnic La Fe **Zip:** 46026 **Location 54:** **City:** Taichung **Contacts:** ***Contact 1:*** - **Name:** An-Chyi Chen - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Taiwan **Facility:** China Medical University Hospital **Zip:** 404332 **Location 55:** **City:** Tainan **Contacts:** ***Contact 1:*** - **Name:** Yen-Yin Chou - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Taiwan **Facility:** National Cheng-Kung Uni. Hosp. **Zip:** 704 **Location 56:** **City:** Taipei **Contacts:** ***Contact 1:*** - **Name:** Yen-Hsuan Ni - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Taiwan **Facility:** National Taiwan University Hospital **Zip:** 10002 **Location 57:** **City:** Taoyuan **Contacts:** ***Contact 1:*** - **Name:** Ming-Wei Lai - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Taiwan **Facility:** Chang Gung Medical Foundation-Linkou Branch **Zip:** 333 **Location 58:** **City:** Bristol **Contacts:** ***Contact 1:*** - **Name:** Dinesh Giri - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United Kingdom **Facility:** Women's and Children's Division Research Unit **State:** Bristol, City Of **Zip:** BS2 8AE **Location 59:** **City:** Cambridge **Contacts:** ***Contact 1:*** - **Name:** Ismaa Farooqi - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United Kingdom **Facility:** Addenbrooke's Hospital **State:** Cambridgeshire **Zip:** CB2 0SL **Location 60:** **City:** Southampton **Contacts:** ***Contact 1:*** - **Name:** Nikki Davis - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United Kingdom **Facility:** University Hospital Southampton **State:** Hampshire **Zip:** SO16 6YD **Location 61:** **City:** London **Contacts:** ***Contact 1:*** - **Name:** Billy White - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United Kingdom **Facility:** Paediatric and Adolescent OutpatientsElizabeth Garrett Anderson WingUniversity College Hospital **State:** London, City Of **Zip:** WC1E 6DB **Location 62:** **City:** Liverpool **Contacts:** ***Contact 1:*** - **Name:** Senthil Senniappan - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United Kingdom **Facility:** Alder Hey Children's Hospital **Zip:** L14 5AB #### 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: D000050177 - Term: Overweight - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001836 - Term: Body Weight Changes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M5114 - Name: Body Weight - Relevance: HIGH - As Found: Weight - ID: M12701 - Name: Obesity - Relevance: HIGH - As Found: Obesity - ID: M18101 - Name: Weight Gain - Relevance: HIGH - As Found: Weight Gain - ID: M26186 - Name: Overweight - Relevance: LOW - As Found: Unknown - ID: M25307 - Name: Overnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: M5115 - Name: Body Weight Changes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009765 - Term: Obesity - ID: D000001835 - Term: Body Weight - ID: D000015430 - Term: Weight Gain ### Intervention Browse Module - Ancestors - ID: D000054795 - Term: Incretins - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M204206 - Name: Tirzepatide - Relevance: HIGH - As Found: 1600 - ID: M27905 - Name: Incretins - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000629749 - Term: Tirzepatide ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06439264 **Brief Title:** Assessing the Clinical Efficacy of Bentonite Clay Gel on Bone Regeneration in the Treatment of Intra-bony Defects: A Clinico-radiograph Study **Official Title:** Assessing the Clinical Efficacy of Bentonite Clay Gel on Bone Regeneration in the Treatment of Intra-bony Defects: A Clinico-radiograph Study #### Organization Study ID Info **ID:** SVSInstituteDS #### Organization **Class:** OTHER **Full Name:** SVS Institute of Dental Sciences ### Status Module #### Completion Date **Date:** 2024-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05 **Type:** ESTIMATED #### Start Date **Date:** 2023-05-03 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Dr R Viswa Chandra #### Responsible Party **Investigator Affiliation:** SVS Institute of Dental Sciences **Investigator Full Name:** Dr R Viswa Chandra **Investigator Title:** PROFFESSOR AND HEAD OF THE DEPARTMENT **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The aim of this study is to evaluate osseous regeneration efficacy of bentonite gel with hydroxyapatite in comparison with hydroxyapatite incase of intrabony defects The test group includes patients with intrabony defects where flap surgery is will be performed and bentonite clay gel with HA will be placed and in control group only HA is placed. **Detailed Description:** Experimental: Main treatment group bentonite with hydroxyaatite is added into the defect site. Comparator: In patients allocated to control group,only hydroxyapatite is added. ### Conditions Module **Conditions:** - Bone Regeneration ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 24 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In test group, after reflection of flap and degranulation, bone graft i.e., bentonite clay gel with hydroxyapatite will be placed in the void created by the defect and sutures will be placed **Intervention Names:** - Other: bentonite clay gel with hydroxyapatite **Label:** test group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** In control group, after reflection of flap and degranulation, bone graft i.e., hydroxyapatite will be placed in the defect and sutures will be placed. **Intervention Names:** - Other: bentonite clay gel with hydroxyapatite **Label:** control group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - control group - test group **Description:** bentonite clay gel presents great potential for bone healing and it leads to the formation of interconnected microporous structure, which can promote native cell infiltration, proliferation, **Name:** bentonite clay gel with hydroxyapatite **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** 1. Radiovisiography will be used to assess bone regeneration achieved post operatively after 3 months and 6 months. **Measure:** RVG **Time Frame:** baseline , 3months,6months **Description:** 2. Assessment of probing depth using probe at baseline and postoperatively at 3 and 6 months **Measure:** probing depth **Time Frame:** baseline , 3months,6months **Description:** Assessment of clinical attachment level using probe at baseline and post operatively at 3 and 6 months. **Measure:** clinical attachment level **Time Frame:** baseline , 3months,6months #### Secondary Outcomes **Description:** 1. Assessment of plaque - according to Turesky modification of Quigley and Hein Plaque Index, 1970. 2. Assessment of Gingivitis - according to Loe H and Silness P, 1963. **Measure:** 1. Assessment of plaque - according to Turesky modification of Quigley and Hein Plaque Index, 1970. 2. Assessment of Gingivitis - according to Loe H and Silness P, 1963. **Time Frame:** baseline ,3months,6months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Systemically healthy male and female patients of age \>18 years 2. two-walled or three-walled intrabony defects and 3. probing pocket depths (PPD) of ≥ 5mm. Exclusion Criteria: 1. Medically compromised patients, 2. patients \<18 years of age, 3. pregnant women, 4. heavy smokers, and 5. patients who underwent radiotherapy or chemotherapy are excluded. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** viswachandra@hotmail.com **Name:** Dr.viswa chandra MDS **Phone:** 9912161007 **Role:** CONTACT #### Locations **Location 1:** **City:** Mahbūbnagar **Contacts:** ***Contact 1:*** - **Email:** rampalliviswa@gmail.com - **Name:** VISWA CHANDRA PROFESSOR - **Phone:** 9908183071 - **Role:** CONTACT **Country:** India **Facility:** Svs Dental College **State:** Telangana **Status:** RECRUITING **Zip:** 509002 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000000931 - Term: Antidotes - ID: D000020011 - Term: Protective Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4835 - Name: Bentonite - Relevance: HIGH - As Found: rIFN- - ID: M4250 - Name: Antidotes - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000001546 - Term: Bentonite ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06439251 **Brief Title:** Effects of Mulligan Technique With or Without Diclofenac Phonophoresis on Patellofemoral Pain Syndrome. **Official Title:** Effects of Mulligan Technique With or Without Diclofenac Phonophoresis on Pain, Range of Motion and Functional Disability of Knee Joint in Patients With Patellofemoral Pain Syndrome #### Organization Study ID Info **ID:** REC-UOL-546-10-2023 #### Organization **Class:** OTHER **Full Name:** University of Lahore ### Status Module #### Completion Date **Date:** 2024-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07 **Type:** ESTIMATED #### Start Date **Date:** 2023-10-18 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-02-27 **Study First Submit QC Date:** 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Lahore #### Responsible Party **Investigator Affiliation:** University of Lahore **Investigator Full Name:** Zunaira saeed **Investigator Title:** DR. Zunaira Saeed **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The patellofemoral pain syndrome (PFPS) is a common cause for "anterior knee pain" and mainly affects young women. the effectiveness of Mulligan technique with or without diclofenac phonophoresis on pain, range of motion and functional disability of knee joint in patients with patellofemoral pain syndrome is known little. This study, ethically approved, focused on patients with anterior knee pain referred to the Physical Therapy Department from Lahore General Hospital. After eligibility assessments and consent, participants were randomly assigned to Group A (Experimental) or Group B (Control). Over four weeks, three sessions per week, routine physiotherapy and specific exercises will be administered, with Group A receiving additional Phonophoresis using ultrasound and diclofenac gel. Outcome variables (Numeric Pain Rating Scale, KOOS-PF, Universal Goniometer) will be assessed by a blinded assessor at baseline and study completion. **Detailed Description:** Background: The patellofemoral pain syndrome (PFPS) is a common cause for "anterior knee pain" and mainly affects young women without any structural changes such as increased Q-angle or significant pathological changes in articular cartilage. Objective: To evaluate the effectiveness of Mulligan technique with or without diclofenac phonopheresis on pain, range of motion and functional disability of knee joint in patients with patellofemoral pain syndrome. Methodology: This study, ethically approved, focused on patients with anterior knee pain referred to the Physical Therapy Department from Lahore General Hospital. After eligibility assessments and consent, participants were randomly assigned to Group A (Experimental) or Group B (Control). Over four weeks, three sessions per week, routine physiotherapy and specific exercises were administered, with Group A receiving additional Phonophoresis using ultrasound and diclofenac gel. Outcome variables (Numeric Pain Rating Scale, KOOS-PF, Universal Goniometer) were assessed by a blinded assessor at baseline and study completion. ### Conditions Module **Conditions:** - Patellofemoral Pain Syndrome **Keywords:** - Patellofemoral Pain Syndrome, - Mulligan mobilization - Phonophoresis - diclofenac ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 68 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The participants randomly allocated in Group A were receive the Phonophoresis (Ultrasound with Diclofenac gel for 5 minutes and intensities 1 MHz and 1.5 W/cm² pulsed waves was used in the therapy sessions on affected knee with diclofenac gel on ultrasound head) as experimental technique **Intervention Names:** - Combination Product: Group 1 **Label:** Diclofenac Phonophoresis **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The treatment involved routine physiotherapy with TENS at 80 Hz and a pulse duration of 50-100 μs, followed by a 15-minute hot pack. It also included stretching exercises for the hamstring and calf muscles, isometric strengthening of the quadriceps and VMO, straight leg raises with traction, and tibial gliding techniques. The MWM technique consisted of SLR with traction, repeated 10 times with 3 sets and a 1-minute interval in between. **Intervention Names:** - Combination Product: Group 2 **Label:** Mulligan Technique **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Diclofenac Phonophoresis **Description:** The treatment included TENS therapy, hot pack application, stretching exercises, isometric strengthening, straight leg raises with traction, and tibial gliding techniques. Participants in Group A also received Phonophoresis as an experimental technique. **Name:** Group 1 **Type:** COMBINATION_PRODUCT #### Intervention 2 **Arm Group Labels:** - Mulligan Technique **Description:** The treatment included routine physiotherapy with TENS, hot pack application, stretching exercises, isometric strengthening, straight leg raises with traction, and tibial gliding techniques. **Name:** Group 2 **Type:** COMBINATION_PRODUCT ### Outcomes Module #### Primary Outcomes **Description:** The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). **Measure:** Numeric Pain Rating Scale **Time Frame:** 4 weeks **Description:** KOOS-PF is a subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) that specifically measures symptoms and function related to patellofemoral pain and osteoarthritis. It was developed to provide a more detailed assessment in this specific knee condition. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems. This direction, 100 indicating no problems. **Measure:** KOOS-PF Scale **Time Frame:** 4 weeks **Description:** It has a scale for the measurement of the angle. The scale can extend from 0 to 180 degrees for half-circle models or 0 to 360 degrees for full-circle models. **Measure:** Universal Goniometer **Time Frame:** 4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * • Patients of age range 20-45 years and both genders (Rehman, 2021 #171) * Unilateral anterior knee pain persisting for over two months, referred by orthopedic (Rehman, 2021 #171) * Pain scoring rate on numeric pain rating scale (NPRS) \>3 during at least two activities (Rehman, 2021 #171) * Patients with positive Clarke's test/ Patellar grind test (Rehman, 2021 #171) * Pain while going up and down stairs, when sitting with knees flexed and with squatting, kneeling or returning from squat. (Powers, 2017 #172) Exclusion Criteria: * • Patients with other knee pathologies; meniscus tears, bursitis, patellar tendon injury, ligamentous injury * Degenerative joint disorders; knee osteoarthritis, rheumatoid arthritis etc. * Patellofemoral dislocation and / or frequent subluxation. * Patients having undergone lower extremity surgery * Those taking any pain medications **Maximum Age:** 45 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** zunairasaeed444@gmail.com **Name:** Zunaira Saeed, Masters **Phone:** +923024728701 **Role:** CONTACT **Contact 2:** **Email:** dr.umber21@gmail.com **Name:** Umber Nawaz, PhD **Phone:** +923334888279 **Role:** CONTACT #### Locations **Location 1:** **City:** Lahore **Contacts:** ***Contact 1:*** - **Name:** Hafiz Ijaz Ahmed Burq, PhD - **Role:** CONTACT **Country:** Pakistan **Facility:** Lahore General Hospital **State:** Punjab **Status:** RECRUITING **Zip:** 57000 #### Overall Officials **Official 1:** **Affiliation:** University of Lahore **Name:** Zunaira Saeed, Masters **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** University of Lahore **Name:** Umber Nawaz, PhD Scholar **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** University of Lahore **Name:** Ashfaq Ahmad, PhD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Access Criteria:** by email **Description:** After the completion of the study **Info Types:** - STUDY_PROTOCOL - SAP **IPD Sharing:** YES **Time Frame:** After the completion of the study, tentatively in 2025 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000001523 - Term: Mental Disorders - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M25706 - Name: Patellofemoral Pain Syndrome - Relevance: HIGH - As Found: Patellofemoral Pain Syndrome - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M15803 - Name: Somatoform Disorders - Relevance: HIGH - As Found: Pain Syndrome - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000046788 - Term: Patellofemoral Pain Syndrome - ID: D000013577 - Term: Syndrome - ID: D000013001 - Term: Somatoform Disorders ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Analg - Name: Analgesics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M7197 - Name: Diclofenac - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06439238 **Brief Title:** Feasibility of Conducting a Pilot Telehealth Study Assessing the Removal of Filter Ventilation on Smoking Behavior and Biomarkers in Menthol Smokers Switched to Non-menthol Cigarettes **Official Title:** Feasibility of Conducting a Pilot Telehealth Study Assessing the Removal of Filter Ventilation on Smoking Behavior and Biomarkers in Menthol Smokers Switched to Non-menthol Cigarettes #### Organization Study ID Info **ID:** #2020LS110 #### Organization **Class:** OTHER **Full Name:** University of Minnesota ### Status Module #### Completion Date **Date:** 2025-03-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-03-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-08 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Minnesota #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This decentralized clinical trial assesses the feasibility of conducting a tobacco product evaluation study remotely via telehealth visits and mailed samples. This is an open label, between-subject, randomized pilot study to assess the effect of minimal filter ventilation vs. moderate filter ventilation on smoking behavior and biomarkers of exposure (e.g., nicotine, carbon monoxide) in menthol smokers switched to non-menthol cigarettes. Subjective measures, alveolar carbon monoxide, blood pressure and cigarettes smoked per day will be collected remotely. Biological samples will be collected at home and mailed into the clinic. ### Conditions Module **Conditions:** - Smoking ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This is an open label, between-subject, randomized pilot study ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Smokers regularly using menthol cigarettes (at least 80% of the time) who meet eligibility criteria will enter 2 weeks of monitoring of usual brand smoking. Randomized to ventilated non-menthol cigarettes **Intervention Names:** - Other: ventilated non-menthol cigarettes **Label:** Menthol cigarettes smokers group 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Smokers regularly using menthol cigarettes (at least 80% of the time) who meet eligibility criteria will enter 2 weeks of monitoring of usual brand smoking. Randomized to minimally ventilated non-menthol cigarettes **Intervention Names:** - Other: minimally ventilated non-menthol cigarettes **Label:** Menthol cigarettes smokers group 2 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Menthol cigarettes smokers group 1 **Description:** a 4-week intervention where participants will be using ventilated non-menthol cigarettes. Weekly telehealth visits will be conducted during baseline and the 4 weeks on study cigarettes to collect study measures followed by a follow-up one month after end of intervention. **Name:** ventilated non-menthol cigarettes **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Menthol cigarettes smokers group 2 **Description:** a 4-week intervention where participants will be using minimally ventilated non-menthol cigarettes. Weekly telehealth visits will be conducted during baseline and the 4 weeks on study cigarettes to collect study measures followed by a follow-up one month after end of intervention. **Name:** minimally ventilated non-menthol cigarettes **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Number of 24 hour quit attempts. **Measure:** quit attempts **Time Frame:** 10 weeks **Description:** This is a 7-question test that assesses physical nicotine dependence. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. In scoring the Fagerstrom Test for Nicotine Dependence, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine. **Measure:** Mean of the Fagerström Test for Nicotine Dependence (FTND) **Time Frame:** 4 weeks **Description:** It measures self-reported, subjective reinforcing and aversive effects of smoking. It contains 19 questions and answers vary from 1(not at all) to 7 (extremely). The higher the score, the greater the reinforcement of cigarette behavior. **Measure:** Mean of the subscales of the modified Cigarette Evaluation Questionnaire (mCEQ) **Time Frame:** 4 weeks **Description:** assesses perceived health risks of tobacco use, study brand of cigarettes. This scale involves rating the extent of perceived risk of a product for different lung cancer. It involves rating perceived disease risk on a 1-10 visual analogue scale with 1 anchored at very low risk for disease and 10 anchored at very high risk. **Measure:** Perceived health risks **Time Frame:** 4 weeks #### Primary Outcomes **Description:** Percent of drop-outs by 4 week visit **Measure:** feasibility- drop-out rate **Time Frame:** 4 weeks **Description:** Percent reporting difficulty collecting data in the Study Feasibility Questionnaire and Interview **Measure:** feasibility-date collection **Time Frame:** 4 weeks #### Secondary Outcomes **Description:** Change in mean cigarettes per day (CPD) based on 7 day ITR data before visit **Measure:** Cigarettes smoked **Time Frame:** baseline and week 4 visit **Description:** Change in cotinine from baseline to the week 4 visit. **Measure:** cotinine change **Time Frame:** 4 weeks **Description:** Change in carbon monoxide (CO) from baseline to the week 4 visit. **Measure:** carbon monoxide change **Time Frame:** 4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or females at least 21 years of age. * Smoking menthol cigarettes most of the time (80% of cigarette purchases). * Self-report of daily smoking of at least 5 - 25 cigarettes for \>= 3 months by self-report. * Carbon monoxide indicative of regular smoking (CO \> 6ppm) prior to randomization. * Has regular access to a smartphone or tablet for use with CO device and smartphone, tablet or computer with functioning camera and internet access for telehealth visits and surveys. Exclusion Criteria: * Unstable health conditions (any significant serious, unstable medical condition including, but not limited to, cardiovascular disease, liver or kidney disease, COPD, bronchitis, within the past 3 months, seizure disorder and cancer (cancer-free \<= years except some skin cancers can be within 5 years), or a COVID-19 positive test or COVID-19 symptoms in the last 30 days or as determined by the licensed medical professional at each site). * Purchased alternative nicotine products within the last month * Unstable mental health (to be determined by medical history, Patient Health Questionnaire-2 (Prime-MD) and GAD-2 after review by the licensed medical professional at each site). * Excessive drinking or problems with drinking or drugs (assessed by PI or licensed medical professional). * Currently pregnant, breastfeeding or intending to become pregnant for the duration of the study or unwilling to agree to use adequate protection to avoid pregnancy. * Taking exclusionary medications, unstable dosing of medications, or unstable control of symptoms for ongoing medical conditions (medications or conditions that would impact biomarkers or patient safety to be determined by the licensed medical professional). * Vital signs outside of the following range: i. Systolic BP greater than or equal to 160 ii. Diastolic BP greater than or equal to 100 iii. Systolic BP below 90 and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint) iv. Diastolic BP below 50 and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint) v. Heart rate greater than or equal to 105 bpm vi. Heart rate lower than 45 bpm and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint) (Participants failing for heart rate or blood pressure will be allowed to re-screen once). * Household member enrolled in the study concurrently. * Participated in prior research study during the past three months that would impact baseline smoking or response to study products. * Inability to independently read and comprehend the consent form and follow other written study instructions, materials or measures or behavior indicating inability to fully participate in study procedures. Participants are required to complete the protocol at home independently and must show ability to comply with directions. * Unstable living environment that would compromise the ability to sequester study products or complete study procedures. **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** dcarroll@umn.edu **Name:** Dana Carroll, PhD **Phone:** (612) 624-0132 **Role:** CONTACT #### Locations **Location 1:** **City:** Minneapolis **Contacts:** ***Contact 1:*** - **Email:** dcarroll@umn.edu - **Name:** Dana Carroll - **Role:** CONTACT **Country:** United States **Facility:** University of Minnesota **State:** Minnesota **Status:** RECRUITING **Zip:** 55414 #### Overall Officials **Official 1:** **Affiliation:** University of Minnesota **Name:** Dorothy Hatsukami, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11591 - Name: Menthol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06439225 **Acronym:** OPTION-DDR **Brief Title:** Platinum and Taxane Chemo in Met Castration Resistant Prostate Cancer Patients With Alterations in DNA Damage Response Genes **Official Title:** A Randomized Phase III Trial Investigating Platinum and Taxane Chemotherapy in Metastatic Castration Resistant Prostate Cancer Patients With Alterations in DNA Damage Response Genes #### Organization Study ID Info **ID:** PR25 #### Organization **Class:** NETWORK **Full Name:** Canadian Cancer Trials Group ### Status Module #### Completion Date **Date:** 2030-03-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2029-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-31 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Canadian Institutes of Health Research (CIHR) #### Lead Sponsor **Class:** NETWORK **Name:** Canadian Cancer Trials Group #### 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 usual approach for most patients who are not in a study is treatment with docetaxel. This study is being done to answer the following question: Can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual approach? This study is being done to find out if this approach is better or worse than the usual approach for prostate cancer. The usual approach is defined as the care most people get for prostate cancer. **Detailed Description:** If taking part in this study, the patient will either get docetaxel, or carboplatin in addition to docetaxel. In both cases, the cancer will be monitored by CT scans and bone scans every 9 weeks, and blood tests every 3 weeks. Study treatments, scans, and tests will continue until the disease gets worse. After finishing study treatment, even if treatment is stopped before the disease gets worse, the study doctor will continue to follow patients condition, watch for side effects and keep track of the health of the patient. If treatment is stopped before the disease got worse, patients will be asked to continue getting CT scans and bone scans every 9 weeks, and blood tests every 3 weeks, until the disease worsens. If the disease gets worse while receiving treatment, or after treatment is stopped, the patient will be contacted by phone every 3 months for the rest of their life to monitor their status. Patients may be seen more often if the study doctor thinks it is necessary. ### Conditions Module **Conditions:** - Metastatic Castration-resistant Prostate Cancer - Metastatic Prostate Cancer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 236 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Docetaxel **Label:** Docetaxel **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Drug: Docetaxel - Drug: Carboplatin **Label:** Carboplatin + Docetaxel **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Carboplatin + Docetaxel - Docetaxel **Description:** 75mg/m2 q21 days **Name:** Docetaxel **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Carboplatin + Docetaxel **Description:** AUC5 q21 days **Name:** Carboplatin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Overall Survival **Time Frame:** 5.25 years #### Secondary Outcomes **Description:** Defined as a reduction in PSA from baseline by 50% **Measure:** To compare the two treatment arms with respect to PSA response **Time Frame:** 5.25 years **Description:** as defined by PCWG3 and RECIST 1.1 **Measure:** To compare the two treatment arms with respect to progression free survival **Time Frame:** 5.25 years **Measure:** To compare the two treatment arms with respect to time to next systemic therapy **Time Frame:** 5.25 years **Description:** Utilizing CTCAE version 5.0 **Measure:** To compare the two treatment arms with respect to time to number and severity of adverse events **Time Frame:** 5.25 years **Measure:** To compare the two treatment arms with respect to patient-reported Quality of Life (QoL) quantified by FACT-P questionnaire **Time Frame:** 5.25 years **Measure:** To compare the two treatment arms with respect to patient-reported Quality of Life (QoL) quantified by FACT-Taxane questionnaire **Time Frame:** 5.25 years **Measure:** To compare the two treatment arms with respect to patient-reported Quality of Life (QoL) quantified by BPI-SF questionnaire **Time Frame:** 5.25 years **Description:** Health system resources will be identified as, but not limited to, clinic visits, treatments (radiation, surgery, medication), physician encounters, hospitalizations related to treatment and complications, emergent visits and diagnostics. **Measure:** Economic Evaluation of healthcare utilization **Time Frame:** 5.25 years **Measure:** Economic Evaluation of health utilities measured by Eq-5D-5L **Time Frame:** 5.25 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Histologic diagnosis of adenocarcinoma of the prostate. The presence of neuroendocrine or small cell carcinoma will be exclusionary * Prior treatment with any ARPI, such as abiraterone, enzalutamide, apalutamide, or darotlutamide, is required. * Participants must have recovered to ≤ grade 1 from all reversible toxicity related to prior systemic or radiation therapy, with the exception of chemotherapy induced alopecia and grade 2 peripheral neuropathy, and have adequate washout as follows: * Longest of one of the following: * Two weeks * 5 half lives for investigational agents * Standard cycle length of standard therapies * Previous major surgery is permitted provided that surgery occurred at least 28 days prior to participant enrollment and that wound healing has occurred * Prior external beam radiation is permitted provided a minimum of 7 days have elapsed between the last dose of radiation and date of enrollment * Radiologically documented presence of metastatic disease within 28 days prior to randomization * Disease progression after ARPI therapy as assessed by the investigator with at least one of the following: * PSA progression with a minimum of two rising PSA values at least 1 week apart, at least 25% and 2ug/L above baseline/nadir. * Radiographic progression of soft tissue disease by RECIST 1.1 criteria or bone metastases by PCWG3 criteria. * Medical or surgical castration with serum testosterone levels \<50ng/dL or \<1.7mmol/L * Qualifying Tier I or Tier II (clinically significant/likely clinically significant or pathogenic / likely pathogenic) germline or somatic alterations involving one or more of the following DDR genes: BRCA1, BRCA2, ATM, ATR, BRIP1, BARD1, CDK12, CHEK1, CHEK2, ERCC2, FANCA, FANCC, FANCD2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD54L. Monoallelic gene deletions in isolation will not be eligible. * Age 18 years or older. * Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2 * Participants must have adequate organ and marrow function measured within 14 days prior to enrolment * Life expectancy \> 12 weeks. * If the participant and the participant's partner are of childbearing potential, they must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 6 months after the last dose of study drug. * Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and health utility questionnaires in either English or French * Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrollment in the trial to document their willingness to participate. * Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up. * In accordance with CCTG policy, protocol treatment is to begin within 2 working days after participant enrolment. Exclusion Criteria: * Received prior platinum chemotherapy (i.e. carboplatin, cisplatin, oxaliplatin, satraplatin) at any time; received prior taxane chemotherapy (docetaxel, paclitaxel, cabazitaxel) with the exception of docetaxel for mCSPC as long as it was no more than 6 cycles and at least 12 months have elapsed from their last treatment to the date of enrollment. * Active anticancer systemic therapy or investigational agents within 14 days of randomization. * Uncontrolled intercurrent illness including, but not limited to: active infection, symptomatic congestive heart failure (NYHA Class III or IV heart disease), unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension or psychiatric illness/social situations that would limit compliance with study requirements. * Participants with myelodysplastic syndrome/acute myeloid leukemia. * Malignancy within the previous 2-years with a \> 30% probability of recurrence within 12 months, with the exception of non-melanoma skin cancer, and in-situ or superficial bladder cancer. * Participants with known symptomatic brain metastasis. However, participants with asymptomatic, treated brain metastases that have been stable for at least 12 weeks are eligible for study entry. * Participants with symptomatic or impending cord compression unless appropriately treated beforehand and clinically stable and asymptomatic. * Presence of a condition or situation, which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with participation in the study. * Live attenuated vaccination administered within 30 days prior to randomization. * For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. * Unable to obtain provincial reimbursement of carboplatin and docetaxel **Gender Based:** True **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** mjafri@ctg.queensu.ca **Name:** Mariam Jafri **Phone:** 613-533-6430 **Role:** CONTACT **Contact 2:** **Email:** wparulekar@ctg.queensu.ca **Name:** Wendy Parulekar **Phone:** 613-533-6430 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Cross Cancer Institute, Edmonton, Alberta, Canada **Name:** Michael Kolinsky **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Description:** As per CCTG policy **IPD Sharing:** YES **URL:** https://www.ctg.queensu.ca/docs/public/policies/DataSharingandAccessPolicy.pdf ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005834 - Term: Genital Neoplasms, Male - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000005832 - Term: Genital Diseases, Male - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000011469 - Term: Prostatic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14335 - Name: Prostatic Neoplasms - Relevance: HIGH - As Found: Prostate Cancer - ID: M8946 - Name: Genital Neoplasms, Male - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M8944 - Name: Genital Diseases, Male - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14333 - Name: Prostatic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011471 - Term: Prostatic Neoplasms ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000050257 - Term: Tubulin Modulators - ID: D000050256 - Term: Antimitotic Agents - ID: D000050258 - Term: Mitosis Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1668 - Name: Docetaxel - Relevance: HIGH - As Found: Physical - ID: M18650 - Name: Carboplatin - Relevance: HIGH - As Found: System - 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 ### Intervention Browse Module - Meshes - ID: D000016190 - Term: Carboplatin - ID: D000077143 - Term: Docetaxel ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06439212 **Brief Title:** the Efficacy of Ginger Powder as an Analgesic for Intraoperative and Post- Endodontic Pain Management **Official Title:** Assessing the Efficacy of Ginger Powder Capsules as an Analgesic for Intraoperative and Post- Endodontic Pain Management in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial #### Organization Study ID Info **ID:** Ginger as an Analgesic for EPM #### Organization **Class:** OTHER **Full Name:** Cairo University ### Status Module #### Completion Date **Date:** 2025-02-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-30 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-01-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-18 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cairo University #### Responsible Party **Investigator Affiliation:** Cairo University **Investigator Full Name:** Omar Alderbashi **Investigator Title:** Master degree student - Department of Endodontics - Faculty of Dentistry - Cairo University **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The aim of the study is to evaluate the analgesic effect of ginger powder capsules compared to placebo on intra-operative and post-operative pain of single-visit endodontic treatment of mandibular molars with symptomatic irreversible pulpitis. **Detailed Description:** The pharmacological pain management usually includes administration of systemic analgesics, anti-inflammatory drugs, or antibiotics drugs. The inhibition of the inflammatory process is one of the methods to reduce or prevent pain during and after treatment. Ginger has a lengthy history of use as a herbal medicine. Ginger has been used in traditional Chinese and Indian medicine to treat a variety of diseases, including arthritis, stomachaches, diarrhea, nausea, asthma, and respiratory problems. It was discovered that ginger also contains substances that prevent PG production. This discovery gave its anti-inflammatory benefits a solid scientific justification. Following research, it was discovered that some of the components of ginger share pharmacological traits with a novel family of dual-acting NSAIDs. These substances have significantly fewer adverse effects than traditional NSAIDs and can inhibit arachidonic acid metabolism via both the cyclooxygenase (COX) and lipoxygenase (LOX) pathways. Various animal studies have shown that taking dried ginger or ginger extract orally can decrease acute inflammation. Numerous clinical studies back up the effectiveness of ginger in treating osteoarthritis, and in some instances, a noticeable decrease in knee pain has been reported. In some of these studies, it was discovered that ginger, even when used for extended amounts of time, significantly reduced pain and swelling in patients with osteoarthritis, rheumatoid arthritis, and muscular pain. There have been no studies done to evaluate the impact of ginger powder on intra and post-endodontic pain. In order to find the effects of ginger powder capsules on pain after endodontic treatment, the current study was performed. ### Conditions Module **Conditions:** - Endodontic 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:** 50 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Choosing ginger as a pain analgesic is significant due to its anti-inflammatory properties. The presence of active compounds, like shogaols, suggests ginger could provide a clinically effective and safer alternative in managing intra-operative and post-endodontic pain. Patient will receive one capsule of 500mg ginger powder capsule thrice daily for two days. First dose will be administered 1 hour before starting endodontic treatment. **Intervention Names:** - Drug: Ginger powder capsule **Label:** Ginger **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patient will receive one capsule of placebo thrice daily for two days. First dose will be administered 1 hour before starting endodontic treatment. **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Ginger **Description:** Patient will receive one capsule of 500mg ginger powder capsule thrice daily for two days. First dose will be administered 1 hour before starting endodontic treatment. **Name:** Ginger powder capsule **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Patient will receive one capsule of placebo thrice daily for two days. First dose will be administered 1 hour before starting endodontic treatment. **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Pain will be assessed using Heft-Parker visual analog scale (HP-VAS). HP-VAS is an 170 mm scale consisting of numbers from 0 to 170. 0 readings represent "no pain" 1- 54 readings represent "mild pain" 55 - 114 readings represent "moderate pain" 115 - 170 readings represent "severe pain" No to mild pain will be considered as effective medication while moderate to severe pain will be regarded as not effective medication. **Measure:** Postoperative pain **Time Frame:** Pain will be assessed at 6 hours, 12 hours, 24 hours and 48 hours postoperatively #### Secondary Outcomes **Description:** Pain will be assessed using Heft-Parker visual analog scale (HP-VAS). HP-VAS is an 170 mm scale consisting of numbers from 0 to 170. 0 readings represent "no pain" 1- 54 readings represent "mild pain" 55 - 114 readings represent "moderate pain" 115 - 170 readings represent "severe pain" No to mild pain will be considered as effective medication while moderate to severe pain will be regarded as not effective medication. **Measure:** Intraoperative pain **Time Frame:** Pain will be assessed during the procedure **Description:** The patient will be asked if they needed a rescue analgesic or not, when and how many times. **Measure:** Rescue-analgesic intake by the patient after endodontic treatment. **Time Frame:** Taken after 48 hours post-operatively ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients aging between 18-45 years old. 2. Patients with mandibular molar with signs and symptoms of symptomatic irreversible pulpitis. 3. Systemically- healthy patients (ASA I or II). 4. Patients who agree to attend for recall appointments. 5. Patients who can understand pain scale and can sign the informed consent. Exclusion Criteria: 1. Pregnant or lactating female patients. 2. Patients allergic to ginger, articaine or any other medicament material used in the study. 3. History of peptic ulceration. 4. Periapical abscess or fistula. 5. Non-restorable teeth. 6. Moderate or severe marginal periodontitis i.e. pocket probe\>3mm. 7. Patients on Aspirin, Clopidogrel, Dalteparin and Warfarin. 8. Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification. **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** omar-ibrahim@dentistry.cu.edu.eg **Name:** Omar M Alderbashi, Bachelor **Phone:** 00201126831502 **Role:** CONTACT ### References Module #### References **Citation:** Menon P, Perayil J, Fenol A, Rajan Peter M, Lakshmi P, Suresh R. Effectiveness of ginger on pain following periodontal surgery - A randomized cross-over clinical trial. J Ayurveda Integr Med. 2021 Jan-Mar;12(1):65-69. doi: 10.1016/j.jaim.2020.05.003. Epub 2020 Jul 2. **PMID:** 32624375 **Citation:** Rayati F, Hajmanouchehri F, Najafi E. Comparison of anti-inflammatory and analgesic effects of Ginger powder and Ibuprofen in postsurgical pain model: A randomized, double-blind, case-control clinical trial. Dent Res J (Isfahan). 2017 Jan-Feb;14(1):1-7. doi: 10.4103/1735-3327.201135. **PMID:** 28348610 **Citation:** Alshibani N, Al-Kattan R, Alssum L, Basudan A, Shaheen M, Alqutub MN, Al Dahash F. Postoperative Analgesic and Anti-inflammatory Effectiveness of Ginger (Zingiber officinale) and NSAIDs as Adjuncts to Nonsurgical Periodontal Therapy for the Management of Periodontitis. Oral Health Prev Dent. 2022 Jun 13;20(1):227-232. doi: 10.3290/j.ohpd.b3125633. **PMID:** 35695692 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014076 - Term: Tooth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M6984 - Name: Dental Pulp Diseases - Relevance: HIGH - As Found: Endodontic Disease - ID: M14525 - Name: Pulpitis - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M16831 - Name: Tooth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003788 - Term: Dental Pulp Diseases ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Analg - Name: Analgesics - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: T166 - Name: Ginger - Relevance: HIGH - As Found: Liver resection ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06439199 **Acronym:** CYTOK-AZA **Brief Title:** Biological, Prospective Study Evaluating the Dosage of Plasma Cytokines Including the FLT3 Ligand and IL6 of Patients Treated With Non-intensive Chemotherapy **Official Title:** Single-center, Biological, Uncontrolled, Prospective Study Evaluating the Dosage of Plasma Cytokines Including the FLT3 (FMS-like Tyrosine Kinase 3) Ligand and IL6 With a View to Making a First Estimate of Their Prognostic Value on the Outcome of Patients Treated With Non-intensive Chemotherapy Such as Azacytidine for Acute Myelogenous Leukemia (AML), High Risk Myelodysplastic Syndrome (HR-MDS) or Chronic Myelomonocytic Leukemia (CMML) #### Organization Study ID Info **ID:** RC23_0332 #### Organization **Class:** OTHER **Full Name:** Nantes University Hospital ### Status Module #### Completion Date **Date:** 2026-12-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-04-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-02-09 **Study First Submit QC Date:** 2024-05-31 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Institut National de la Santé Et de la Recherche Médicale, France #### Lead Sponsor **Class:** OTHER **Name:** Nantes University Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** There are 2 possible treatments for the treatment of Acute Myelogenous Leukemia (AML), high-risk myelodysplastic syndromes (HR-MDS) or chronic myelomonocytic leukemia (CMML): intensive curative chemotherapy , and for over-aged or co-morbid patients , non-intensive palliative chemotherapy with a hypomethylating agent (Azacytidine) associated or not with venetoclax. Pro-inflammatory cytokines and in particular IL-6 (Interleukin 6) seem to play a key role in the chemoresistance of solid cancers and AML : it would be associated with a poor prognosis of AML , would promote the proliferation of leukemic blasts , and would promote the progression of MDS to AML . In AML treated with intensive chemotherapy, researchers demonstrated that a particular kinetic profile of the FLT3 ligand and IL6 at day 22 could very significantly predict the survival of patients with AML . It therefore seems interesting to study the plasma cytokine profiles in patients with AML, HR-MDS or CMML treated non-intensively, and to see if researchers observe the same prognostic correlation as during intensive chemotherapy. **Detailed Description:** Patients will be divided into 2 groups treated according to a non-intensive chemotherapy : Group 1 : 40 patients treated with Azacytidine and Venetoclax +/- another molecule according to the following schedule: * Azacytidine 75 mg/m² D1 to D7 SC * Venetoclax: 400 mg/day orally in 1 dose between 14 and 28 days per cycle. The cycles will be 28 days long and will be carried out until relapse or death. Cytokine assays will be carried out on D1, D8, D15 and D22 of each cycle for 2 cycles. Group 2 : 20 patients treated with Azacytidine +/- another molecule according to the following schedule: • Azacytidine 75 mg/m² D1 to D7 SC The cycles will be 28 days long and will be carried out until relapse or death. The cytokine assays will be carried out on D1, D8, D15 and D22 of each cycle for 3 cycles. The duration of follow-up for a patient is 12 months from day 1 of the first cycle. ### Conditions Module **Conditions:** - Acute Myeloid Leukemia - Myelodysplastic Syndromes - Chronic Myelomonocytic Leukemia **Keywords:** - Cytokine - IL 6 - FLT3 Ligand - AML - CMML - HR MDS - Azacytidine ### Design Module #### Bio Spec **Description:** During the weekly blood samples taken in the day hospital as part of the treatment, an additional 9 ml EDTA tube will be taken, during the first 2 cycles for group 1 and during the first 3 cycles for group 2.This additional tube will be used to supply this biocollection and to promote the development of knowledge in the field of acute myeloidblastic leukemia, myelodysplasia and chronic myelomonocytic leukemia. **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 40 patients treated with Azacytidine and Venetoclax +/- another molecule according to the following schedule: * Azacytidine 75 mg/m² D1 to D7 SC * Venetoclax: 400 mg/day orally in 1 dose between 14 and 28 days per cycle. The cycles will be 28 days long and will be carried out until relapse or death. Cytokine assays will be carried out on D1, D8, D15 and D22 of each cycle for 2 cycles. **Label:** Azacytidine and Venetoclax #### Arm Group 2 **Description:** 20 patients treated with Azacytidine +/- another molecule according to the following schedule: • Azacytidine 75 mg/m² D1 to D7 SC The cycles will be 28 days long and will be carried out until relapse or death. The cytokine assays will be carried out on D1, D8, D15 and D22 of each cycle for 3 cycles. The duration of follow-up for a patient is 12 months from day 1 of the first cycle. **Label:** Azacytidine ### Outcomes Module #### Primary Outcomes **Description:** Determination of plasma cytokines (Flt3-L, IL1beta, IL6, IL8/CXCL8, IL10, IL15, IL17A, IL17E, IL17-F, IL18, GM-CSF (granulocyte-monocyte colony-stimulating factor, TNFalpha) by Luminex at diagnosis and during treatment of adult patients with of AML, SMD-HR (High risk myelodysplastic syndrome) or CMML(Chronic myelomonocytic leukemia) treated non-intensively **Measure:** Evaluation of cytokine profiles (Flt3-L, IL (Interleukin) 1beta, IL6, IL8/CXCL8, IL10, IL15, IL17A, IL17E, IL17-F, IL18, GM-CSF, TNFalpha) in patients treated non-intensively for AML, SMD-HR or an LMMC. **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria : * Age \>=18 years * AML or SMD-HR or CMML in first line or in relapse receiving a hypomethylating agent +/- another molecule or a hypomethylating agent in combination with venetoclax +/- another molecule. * Patient having agreed to participate in the study (information note signature) and having signed the biocollection consent Exclusion Criteria : * No social security or any other regime * Pregnant women or patient unable to take contraception in case of fertility * Breastfeeding women * Minors * Adults under guardianship, curators or safeguard of justice **Maximum Age:** 99 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** 40 patients treated with Azacytidine and Venetoclax +/- another molecule and 20 patients treated with Azacytidine +/- another molecule. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** alice.garnier@chu-nantes.fr **Name:** Alice GARNIER, PH **Phone:** 33 2 44 76 80 81 **Role:** CONTACT #### Locations **Location 1:** **City:** Nantes **Contacts:** ***Contact 1:*** - **Email:** alice.garnier@chu-nantes.fr - **Name:** Alice GARNIER, PH - **Phone:** 33 2 44 76 80 81 - **Role:** CONTACT **Country:** France **Facility:** Nantes University Hospital **State:** Loire-Atlantique **Zip:** 44093 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000006402 - Term: Hematologic Diseases - ID: D000007951 - Term: Leukemia, Myeloid - ID: D000001855 - Term: Bone Marrow Diseases - ID: D000011230 - Term: Precancerous Conditions - ID: D000054437 - Term: Myelodysplastic-Myeloproliferative Diseases - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10945 - Name: Leukemia - Relevance: HIGH - As Found: Leukemia - ID: M10955 - Name: Leukemia, Myeloid - Relevance: LOW - As Found: Unknown - ID: M18127 - Name: Leukemia, Myeloid, Acute - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M14164 - Name: Preleukemia - Relevance: HIGH - As Found: Myelodysplastic Syndrome - ID: M18132 - Name: Leukemia, Myelomonocytic, Chronic - Relevance: HIGH - As Found: Chronic Myelomonocytic Leukemia - ID: M27706 - Name: Leukemia, Myelomonocytic, Juvenile - Relevance: HIGH - As Found: Chronic Myelomonocytic Leukemia - ID: M12145 - Name: Myelodysplastic Syndromes - Relevance: HIGH - As Found: Myelodysplastic Syndrome - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M5134 - Name: Bone Marrow Diseases - Relevance: LOW - As Found: Unknown - ID: M14111 - Name: Precancerous Conditions - Relevance: LOW - As Found: Unknown - ID: M12149 - Name: Myeloproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M27707 - Name: Myelodysplastic-Myeloproliferative 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: T3995 - Name: Myeloid Leukemia - Relevance: LOW - As Found: Unknown - ID: T182 - Name: Acute Myeloid Leukemia - Relevance: HIGH - As Found: Acute Myeloid Leukemia - ID: T188 - Name: Acute Non Lymphoblastic Leukemia - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T3993 - Name: Myelodysplastic Syndromes - Relevance: HIGH - As Found: Myelodysplastic Syndrome - ID: T1310 - Name: Chronic Myelomonocytic Leukemia - Relevance: HIGH - As Found: Chronic Myelomonocytic Leukemia - ID: T3174 - Name: Juvenile Myelomonocytic Leukemia - Relevance: HIGH - As Found: Chronic Myelomonocytic Leukemia - ID: T1311 - Name: Chronic Myeloproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: T3994 - Name: Myelodysplastic/myeloproliferative Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007938 - Term: Leukemia - ID: D000011289 - Term: Preleukemia - ID: D000015477 - Term: Leukemia, Myelomonocytic, Chronic - ID: D000054429 - Term: Leukemia, Myelomonocytic, Juvenile - ID: D000009190 - Term: Myelodysplastic Syndromes ### 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: M249656 - Name: Venetoclax - Relevance: LOW - As Found: Unknown - ID: M4673 - Name: Azacitidine - Relevance: LOW - As Found: Unknown - ID: M247427 - Name: Flt3 ligand protein - Relevance: LOW - As Found: Unknown - ID: T22 - Name: Tyrosine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06439186 **Brief Title:** The Use of Infiltrative Anesthesia Instead of Inferior Alveolar Block **Official Title:** Infiltrative Anesthesia With Lidocaine Can Replace The Inferior Alveolar Nerve Block In Extraction of Devitalized Mandibular Molar Teeth #### Organization Study ID Info **ID:** KonyaNEU 2 #### Organization **Class:** OTHER **Full Name:** Konya Necmettin Erbakan Üniversitesi ### Status Module #### Completion Date **Date:** 2023-10-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-05-01 **Type:** ACTUAL #### Start Date **Date:** 2022-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-02 **Study First Submit QC Date:** 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Konya Necmettin Erbakan Üniversitesi #### Responsible Party **Investigator Affiliation:** Konya Necmettin Erbakan Üniversitesi **Investigator Full Name:** Kubilay Isik **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:** Generally it is accepted that infiltrative anesthesia (IA) is not sufficient for extraction of lower molars and that an inferior alveolar nerve block (IANB) is needed. In this study, it was aimed to compare the effectiveness of IANB and IA in extraction of devitalized mandibular molars. Sixty subjects are randomly divided into study (n=30) and control (n=30) groups. Lidocaine with epinephrine is used for all injections. In the study group only vestibular and lingual IA will be used. In the control group, IANB will be applied. Teeth were extracted as usual. The pain felt during extraction will be compared. **Detailed Description:** It has been taught in dental curricula that using only infiltrative anesthesia (IA) is not sufficient for extraction of lower molars and that an inferior alveolar nerve block (IANB) is needed. However, it is also well-known that dental implants can be inserted into mandibular posterior region using only IA. It can be claimed that there is no difference regarding the need for anesthesia between extracting a devitalized tooth and placing an implant in the same area. In this study, it was aimed to compare the effectiveness of IANB and IA in extraction of mandibular molars that had previously undergone root canal treatment. The study is as a prospective, randomized, and non blinded clinical trial. All procedures are carried out at Necmettin Erbakan University, Faculty of Dentistry. The inclusion criteria are: age \> 18 years, the tooth to be extracted is a mandibular first or second molar with a previously completed root canal treatment. The patients allergic to local anesthetics, those with severely mobile teeth, those had severe pain due to an acute infection, and the patients using psychotropic drugs are excluded. Sixty subjects are randomly divided into study (n=30) and control (n=30) groups. An anesthetic solution containing 20 mg/mL of lidocaine and 0.0125 mg/mL of epinephrine was used in all subjects. In the study group only vestibular and lingual IA will be used. In the control group, IANB will be applied. The teeth will be extracted as usual. Using a visual analog scale (VAS), the pain felt during extraction will be separately recorded. Mann-Whitney U test will be used for statistical analysis. Statistical significance is defined as p\<.05. ### Conditions Module **Conditions:** - Local Infiltration ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ACTUAL **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In the first group, inferior alveolar anesthesia is used. In the second group, infiltrative anesthesia is used. In both groups, one dose of lidocaine HCl contained in 2 mL ampule is used. It is a standard drug. **Intervention Names:** - Drug: Lidocain **Label:** Anesthesia **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** In both groups, the patient is asked to evaluate the pain she/he experienced during the extraction. This evaluation is done immediately after the extraction, by using a "visual analogue scale" (detailed in other sections of this trial record). **Intervention Names:** - Drug: Lidocain **Label:** tooth extraction pain **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Anesthesia - tooth extraction pain **Description:** Local anesthesia **Name:** Lidocain **Other Names:** - Lidocaine **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** This is a 100 mm linear scale used to measure pain. On the left end is a description: "No pain at all. On the right end, there is the description "The worst pain imaginable." The patient will be asked to mark the pain on this line and then the distance from the left end to the mark will be measured. **Measure:** Visual analogue scale **Time Frame:** Immediately after the tooth extraction. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * the patient is older than 18 years * the tooth to be extracted is a mandibular first or second molar with a previously completed root canal treatment Exclusion Criteria: * The patients allergic to local anesthetics * Those with severely mobile teeth * Those had severe pain due to an acute infection * The patients using psychotropic drugs **Healthy Volunteers:** True **Maximum Age:** 62 Years **Minimum Age:** 19 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Konya **Country:** Turkey **Facility:** Necmettin Erbakan University, Faculty of Dentistry #### Overall Officials **Official 1:** **Affiliation:** Necmettin Erbakan University **Name:** Ali R Tunçdemir, PhD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000000779 - Term: Anesthetics, Local - ID: D000000777 - Term: Anesthetics - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000000889 - Term: Anti-Arrhythmia Agents - ID: D000061567 - Term: Voltage-Gated Sodium Channel Blockers - ID: D000026941 - Term: Sodium Channel Blockers - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: ChanBlk - Name: Channel Blockers - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11014 - Name: Lidocaine - Relevance: HIGH - As Found: Solution - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown - ID: M4213 - Name: Anti-Arrhythmia Agents - Relevance: LOW - As Found: Unknown - ID: M23177 - Name: Sodium Channel Blockers - Relevance: LOW - As Found: Unknown - ID: M30025 - Name: Diuretics, Potassium Sparing - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000008012 - Term: Lidocaine ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06439173 **Brief Title:** Study of the Hematopoietic Niche and the Role of Inflammation in the Pathophysiology of Cytopenias After CAR-T Cell Therapy: Potential of Therapies Directed to Repair the Bone Marrow Microenvironment **Official Title:** Study of the Hematopoietic Niche and the Role of Inflammation in the Pathophysiology of Cytopenias After CAR-T Cell Therapy: Potential of Therapies Directed to Repair the Bone Marrow Microenvironment #### Organization Study ID Info **ID:** PI23/01107 #### Organization **Class:** OTHER **Full Name:** Instituto de Investigación Biomédica de Salamanca #### Secondary ID Infos **Domain:** Ethics Committee for Drug Research of the Salamanca Health Area **ID:** PI2024 03 1552 **Type:** REGISTRY ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-04-18 **Study First Submit QC Date:** 2024-05-31 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Carlos III Health Institute #### Lead Sponsor **Class:** OTHER **Name:** Instituto de Investigación Biomédica de Salamanca #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Immunotherapy with chimeric antigen receptor T-cells (CAR-T) has revolutionized the treatment of oncohematological diseases and its applications in solid tumors and non-neoplastic diseases are advancing. Cytopenias after CAR-T therapy are the most frequent complication in the medium and long term after treatment, they are a cause of morbimortality, and there are no effective therapies available. The general objective of the present research project is to analyze, in a series of 40 patients with diffuse large B-cell lymphoma undergoing consecutive commercial CAR-T therapy at the University Hospital of Salamanca, the characteristics of the hematopoietic niche and the systemic and bone marrow inflammatory status in patients with prolonged cytopenias after CAR-T cell therapy with respect to those without cytopenias and with respect to the pre-treatment situation (performing quantitative and functional analysis of the stroma by immunohistochemistry, flow cytometry and genomic studies, in addition to functional hematopoietic assays-clonogenic assays, long-term cultures-), and to evaluate both in vitro (by co-culturing with macrophages activated by CAR-T/tumor cell interaction and assessing cytokines) and in vivo (in an animal model of lymphoma and CRS) the therapeutic potential of therapies aimed at repairing the hematopoietic bone marrow microenvironment, such as the use of allogeneic mesenchymal cells (MSC) from healthy donors and MSC-derived extracellular vesicles (MSC-EV) studying their effects on inflammatory mediators, hematopoiesis and the cytotoxic effect of CAR-T. ### Conditions Module **Conditions:** - Diffuse Large B Cell Lymphoma **Keywords:** - Lymphoma B Cell - CAR-T Therapy - Cytopenia - Hematopoietic Niche - Inflammation ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Patients with diffuse large B-cell lymphoma undergoing consecutive commercial CAR-T therapy at the University Hospital of Salamanca **Name:** CAR-T cell therapy **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** To analyze the characteristics of the hematopoietic niche in patients experiencing prolonged cytopenias post CAR-T cell therapy compared to those without cytopenias and their pre-treatment status. **Measure:** Characterizing hematopoietic niche post CAR-T Therapy **Time Frame:** 36 months **Description:** To analyze the characteristics of systemic inflammatory status in patients experiencing prolonged cytopenias post CAR-T cell therapy compared to those without cytopenias and their pre-treatment status. **Measure:** Characterizing systemic inflammation post CAR-T Therapy **Time Frame:** 36 months **Description:** To analyze the characteristics of medullary inflammatory status in patients experiencing prolonged cytopenias post CAR-T cell therapy compared to those without cytopenias and their pre-treatment status. **Measure:** Characterizing medullary inflammation post CAR-T Therapy **Time Frame:** 36 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with diffuse large B-cell lymphoma undergoing consecutive commercial CAR-T therapy * Over 18 years old * Sign the informed consent Exclusion Criteria: * Under 18 years old * Do not sign the informed consent **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with diffuse large B-cell lymphoma undergoing consecutive commercial CAR-T therapy at the University Hospital of Salamanca ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ferminsg@usal.es **Name:** Fermín Sánchez-Guijo Martín, PhD MD **Phone:** +34 923 291384 **Role:** CONTACT **Contact 2:** **Email:** smuntion@usal.es **Name:** Sandra Muntión Olave, PhD **Phone:** +34 923 291200 **Phone Ext:** 55031 **Role:** CONTACT #### Locations **Location 1:** **City:** Salamanca **Contacts:** ***Contact 1:*** - **Email:** ferminsg@usal.es - **Name:** Fermín Sánchez-Guijo Martín, PhD MD - **Phone:** +34 923 291384 - **Role:** CONTACT ***Contact 2:*** - **Email:** smuntion@usal.es - **Name:** Sandra Muntión Olave, PhD - **Phone:** +34 923 291200 - **Phone Ext:** 55015 - **Role:** CONTACT **Country:** Spain **Facility:** Complejo Asistencial Universitario de Salamanca **Status:** RECRUITING **Zip:** 37007 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008223 - Term: Lymphoma - 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: D000010335 - Term: Pathologic Processes - ID: D000016393 - Term: Lymphoma, B-Cell - ID: D000008228 - Term: Lymphoma, Non-Hodgkin - ID: D000006402 - Term: Hematologic Diseases ### 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: BC20 - Name: Immune System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10293 - Name: Inflammation - Relevance: HIGH - As Found: Inflammation - ID: M11220 - Name: Lymphoma - Relevance: LOW - As Found: Unknown - ID: M18828 - Name: Lymphoma, B-Cell - Relevance: LOW - As Found: Unknown - ID: M18831 - Name: Lymphoma, Large B-Cell, Diffuse - Relevance: HIGH - As Found: Diffuse Large B-Cell Lymphoma - ID: M3170 - Name: Cytopenia - Relevance: HIGH - As Found: Cytopenia - 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: M9490 - Name: Hematologic Diseases - 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: D000016403 - Term: Lymphoma, Large B-Cell, Diffuse - ID: D000095542 - Term: Cytopenia - ID: D000007249 - Term: Inflammation ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06439160 **Acronym:** SOCINTERACAN **Brief Title:** Exploring the Changes in Social Interaction and Its Protective Features in Anorexia Nervosa **Official Title:** Exploring the Changes in Social Interaction and Its Protective Features in Anorexia Nervosa #### Organization Study ID Info **ID:** 49C401 #### Organization **Class:** OTHER **Full Name:** Istituto Auxologico Italiano ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-05 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-04 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-01-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-10 **Type:** ACTUAL **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-31 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Turin, Italy **Class:** OTHER **Name:** Catholic University of the Sacred Heart #### Lead Sponsor **Class:** OTHER **Name:** Istituto Auxologico Italiano #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Anorexia Nervosa (AN) is an eating disorder often characterised by restriction of food intake, being underweight, body image uneasiness, and the possibility of binge eating, purging, fasting behaviours, and excessive exercising. Despite weight and eating habits being one, and perhaps the most recognizable, components of AN, AN is a multidimensional disease. For example, individuals affected by AN might show psychological suffering, such as depression and anxiety. For example, social anxiety disorder/social phobia is the first or second most common comorbid anxiety in AN (i.e. prevalence rates ranging from 16% to 88.2% in AN against 12% in the general population). Moreover, the highest the level of social anxiety the highest the severity of the eating disorder psychopathology. This latter component resonates with findings on the difficulties observed in people affected by AN in creating and maintaining satisfactory relationships with others. These evidences tell us the importance to take into account the social components/skills of people affected by AN. The development of social components/skills of people affected by AN during their recovery can be considered as a protective factor for future relapse. This would be of relevance for the creation of rehabilitative programs. **Detailed Description:** Anorexia Nervosa (AN) is an eating disorder often characterised by restriction of food intake, being underweight, body image uneasiness, and the possibility of binge eating, purging, fasting behaviours, and excessive exercising. AN is of relevance for the health care system because of the high mortality rates, high psychiatric comorbidity, high suicide risk, and because of the high costs for the health system. Despite weight and eating habits being one, and perhaps the most recognizable, components of AN, AN is a multidimensional disease. For example, individuals affected by AN might show psychological suffering, such as depression and anxiety. For example, social anxiety disorder/social phobia is the first or second most common comorbid anxiety in AN (i.e. prevalence rates ranging from 16% to 88.2% in AN against 12% in the general population). Moreover, the highest the level of social anxiety the highest the severity of the eating disorder psychopathology. This latter component resonates with findings on the difficulties observed in people affected by AN in creating and maintaining satisfactory relationships with others. These evidences tell us the importance to take into account the social components/skills of people affected by AN. Therefore, we believe it would be relevant to understand whether our treatments change the social components/skills of the people affected by AN who access our ward's multidisciplinary inpatient intensive rehabilitation treatment. Moreover, it would be important to evaluate the protective role of participants' social components/skills in the changes in their psychopathology. Despite our rehabilitative activities not having a specific focus on sociality, the activities are conducted on a 1:1 or group basis. This means that our activities have an intrinsic relational and socializing value. The purpose of the study lays on two outcomes: * Primary outcome: evaluation of the short-term effects (T0 vs T1) of the multidisciplinary inpatient intensive rehabilitation treatment on the social components/skills of people affected by AN. * Secondary outcome: evaluation of the long-term effects (T0 vs T2) of the multidisciplinary inpatient intensive rehabilitation treatment on the social components/skills of people affected by AN. The development of social components/skills of people affected by AN during their recovery can be considered as a protective factor for future relapse. This would be of relevance for the creation of rehabilitative programs ### Conditions Module **Conditions:** - Anorexia Nervosa **Keywords:** - Anorexia nervosa - Social interaction - Rehabilitation ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 45 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Individuals of both biological sexes affected by AN who will take part in the multidisciplinary inpatient intensive rehabilitation treatment as offered by the U.O. dei Disturbi del Comportamento Alimentare, San Giuseppe Hospital, Piancavallo (VCO), Italy. Inclusion Criteria: i) age between 18 and 65 years old; ii) diagnosis of AN, as per DSM V criteria (APA, 2013); iii) BMI ≤ 17 Kg/m2; iv) adherence to the rehabilitation program, meaning participating at the 75% of the proposed activities. Exclusion criteria: i) presence of other pathologies not associated with AN (i.e., neurodegenerative diseases); ii) severe psychopathologies other than AN (i.e., schizophrenia); iii) spontaneous dropout from the multidisciplinary inpatient intensive rehabilitation treatment. **Intervention Names:** - Other: Participants will be asked to complete a series of questionnaires at t0, t1 and t2 **Label:** anorexia nervosa/AN ### Interventions #### Intervention 1 **Arm Group Labels:** - anorexia nervosa/AN **Description:** Individuals will be people who voluntarily will take part in a residential three to six weeks multidisciplinary inpatient intensive rehabilitation treatment targeting the improvement of psychological well-being, body image, and psychopathology for anorexia nervosa. Therefore, at T0 (at the beginning of the treatment) and T1 (at the end of the rehabilitation programme), participants will fill out some self-report questionnaires to evaluate the effect of the multidisciplinary inpatient intensive rehabilitation treatment on different outcomes (i.e. psychological well-being, eating pathology, body image, and comorbidities), among which their social components/skills. Moreover, we will ask participants to complete 3 months after discharge the questionnaires related to the social components/skills only. Participants will be contacted by email, within the email participants will find a link to click on for the completion of the questionnaires. **Name:** Participants will be asked to complete a series of questionnaires at t0, t1 and t2 **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Social anhedonia will be evaluated by the Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS). This self-report questionnaire is made up of 17-item for measuring individuals' tendency to look forward to interactions with others (anticipatory interpersonal pleasure - 7 items) and the experienced pleasure in social interactions (consummatory interpersonal pleasure - 10 items). The ACIPS is scored on a six-point Likert scale ranging from 1 (very false for me) to 6 (very true for me). **Measure:** Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS) **Time Frame:** Through study completion, an average of 4 months **Description:** The scale will be used to assess anxiety about being negatively evaluated by others because of one's overall appearance, including body shape (e.g., "I am concerned people would not like me because of the way I look and I am afraid that people find me unattractive"). The scale contains 16 items rated on a 5-points Likert scale ranging from 1 = not at all to 5 = extremely, with higher scores reflecting a higher social appearance anxiety scale. **Measure:** The Social Appearance Anxiety Scale (SAAS) **Time Frame:** Through study completion, an average of 4 months **Description:** The scale will be used to assess the fear of interacting in dyads and groups (e.g., ''I have difficulty talking with other people''). The scale contains 20 items rated on a 5-points Likert scale ranging from 0 = not at all to 4 = extremely, with a higher score indicating greater social interaction anxiety **Measure:** The Social Interaction Anxiety Scale (SIAS) **Time Frame:** Through study completion, an average of 4 months **Description:** We will administer the scale to evaluate the fear of being scrutinized by others during routine activities, such as eating, drinking, or writing (e.g., ''I become anxious if I have to write in front of other people''). The scale is made up of 20 items rated on a five-points Likert scale ranging from 0 = not at all to 4 = extremely, with a higher score indicating greater fear of scrutiny. **Measure:** Social Phobia Scale (SPS) **Time Frame:** Through study completion, an average of 4 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * age between 18 and 65 years old; * diagnosis of AN, as per DSM V criteria (APA, 2013); * BMI ≤ 17 Kg/m2; * adherence to the rehabilitation program, meaning participating at the 75% of the proposed activities. Exclusion criteria: * presence of other pathologies not associated with AN (i.e., neurodegenerative diseases); * severe psychopathologies other than AN (i.e., schizophrenia); * spontaneous dropout from the multidisciplinary inpatient intensive rehabilitation treatment. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Individuals of both biological sexes affected by AN who will take part in the multidisciplinary inpatient intensive rehabilitation treatment as offered by the U.O. dei Disturbi del Comportamento Alimentare, San Giuseppe Hospital, Piancavallo (VCO), Italy. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** f.brusa@auxologico.it **Name:** Federico Brusa, Ph.D **Phone:** +393517797622 **Role:** CONTACT #### Locations **Location 1:** **City:** Milano **Contacts:** ***Contact 1:*** - **Name:** Istituto Auxologico Italiano - **Role:** CONTACT **Country:** Italy **Facility:** istituto Auxologico italiano IRCSS **State:** MI **Status:** RECRUITING **Zip:** 20145 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012817 - Term: Signs and Symptoms, Digestive - ID: D000001068 - Term: Feeding and Eating Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M4181 - Name: Anorexia - Relevance: HIGH - As Found: Anorexia - ID: M4182 - Name: Anorexia Nervosa - Relevance: HIGH - As Found: Anorexia Nervosa - ID: M15622 - Name: Signs and Symptoms, Digestive - Relevance: LOW - As Found: Unknown - ID: M4380 - Name: Feeding and Eating 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: D000000855 - Term: Anorexia - ID: D000000856 - Term: Anorexia Nervosa ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06439147 **Brief Title:** Comparison Between Two Techniques of Capsulotomy During Capsulorrhaphy in Cases of Developmental Dysplasia of the Hip **Official Title:** U-shaped vs T-shaped Capsular Incision in Capsulorrhaphy During Surgery for Developmental Dysplasia of the Hip, Randomized Controlled Trial #### Organization Study ID Info **ID:** Capsulorrhaphy in DDH #### Organization **Class:** OTHER **Full Name:** Assiut University ### Status Module #### Completion Date **Date:** 2025-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-30 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2024-11 **Type:** ESTIMATED #### Start Date **Date:** 2023-10-11 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assiut University #### Responsible Party **Investigator Affiliation:** Assiut University **Investigator Full Name:** Ahmed Mostafa Thabet Hussien **Investigator Title:** Orthopedic surgery resident **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** comparison of the outcome between using U-shaped incision and T-shaped incision for capsulorrhaphy in management of Developmental dysplasia of the hip **Detailed Description:** Developmental dysplasia of the hip: Developmental dysplasia of the hip is a spectrum of abnormalities of the developing hip joint that ranges from shallowness of the acetabulum to capsular laxity and instability to frank dislocation . Developmental dysplasia of the hip is relatively common, occurring in 1 of 1000 live births. When surgical intervention is decided, open reduction is needed to remove any obstacle that hinders hip reduction. Capsulorrhaphy is an essential step for minimizing instability of the hip after reduction The classic T-shaped capsular incision is done by two incisions: Vertical limb parallel to femoral neck axis and a transverse one parallel to the inguinal ligament resulting into two layers . Suturing them back is somewhat cumbersome after femoral head reduction. Therefore, the suggested technique utilizes a U-shaped incision to make re-suturing of the capsule easier with multiple stitches, and this study compares the outcome between using T-shaped incision and U-shaped incision for capsulorrhaphy after open reduction Femoral osteotomy or Pelvic osteotomy can be used in certain circumstances. ### Conditions Module **Conditions:** - Developmental Dysplasia of the Hip ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** randomized clinical trial ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants on which U shaped capsular incision will be used during capsulorrhaphy **Intervention Names:** - Procedure: U shaped capsular incision during capsulorrhaphy **Label:** U-shaped group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Participants on which T shaped incision will be used during capsulorrhaphy **Intervention Names:** - Procedure: T-shaped capsular incision diuring capsulorraphy **Label:** T-shaped group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - U-shaped group **Description:** Incision of the capsule of the hip during open reduction of Developmental Dysplasia of the Hip,Incision is done with its base proximally. The transverse limb is 1 cm proximal to femoral neck base **Name:** U shaped capsular incision during capsulorrhaphy **Other Names:** - U-shaped Capsulotomy **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - T-shaped group **Description:** Incision of the capsule of the hip during open reduction of Developmental Dysplasia of the Hip done by two incisions: Vertical limb parallel to femoral neck axis and a transverse one parallel to the inguinal ligament resulting into two flabs. **Name:** T-shaped capsular incision diuring capsulorraphy **Other Names:** - T-shaped Capsulotomy **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Postoperative clinical evaluation Grade 1(Excellent):Painless,stable hip,no limp,more than 15 degrees of internal rotation Grade 2(Good):Painless,stable hip,slight limp or decreased motion;negative trendelenburg's sign Grade 3(Fair):Minimum pain,moderate stiffness;Positive trendelenburg sign Grade 4(Poor):Significant pain **Measure:** Modified Mackay's criteria as a clinical evaluation method **Time Frame:** 1 year #### Secondary Outcomes **Description:** calculate the time needed to close the capsule of the hip **Measure:** Operative time ofcapsulorrhaphy **Time Frame:** 1 year **Measure:** Number of stitches taken during capsulorrhaphy **Time Frame:** 1 year **Description:** Recurrent dislocation,pain,Avascular necrosis of the hip **Measure:** any complication detected **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients older than 1 year and younger than 4 years * Unilateral or bilateral cases Exclusion Criteria: * Patients younger than 1 year and older than 4 years old * Secondary hip dislocation ,neuromuscular disorders (as cerebral palsy, myelodysplasia or arthrogryposis). * Patients who will undergo femoral shortening. **Maximum Age:** 4 Years **Minimum Age:** 1 Year **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Assiut **Country:** Egypt **Facility:** Assiut university hospital **Zip:** 71111 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** McKay DW. A comparison of the innominate and the pericapsular osteotomy in the treatment of congenital dislocation of the hip. Clin Orthop Relat Res. 1974 Jan-Feb;(98):124-32. doi: 10.1097/00003086-197401000-00013. No abstract available. **PMID:** 4817221 **Citation:** Glorion C. Surgical reduction of congenital hip dislocation. Orthop Traumatol Surg Res. 2018 Feb;104(1S):S147-S157. doi: 10.1016/j.otsr.2017.04.021. Epub 2017 Dec 2. **PMID:** 29203431 **Citation:** Elbaseet HM, Abdelzaher MA. U-shaped hip capsular incision: An easier way to do hip capsulorrhaphy in developmental dysplasia of the hip - Technical note. Orthop Traumatol Surg Res. 2023 Apr 21:103625. doi: 10.1016/j.otsr.2023.103625. Online ahead of print. **PMID:** 37086945 **Citation:** Zargarbashi R, Bozorgmanesh M, Panjavi B, Vosoughi F. The path to minimizing instability in developmental dysplasia of the hip: is Capsulorrhaphy a necessity or a futile habit? BMC Musculoskelet Disord. 2021 Feb 17;22(1):199. doi: 10.1186/s12891-021-04065-3. **PMID:** 33596895 **Citation:** Li Y, Hu W, Xun F, Lin X, Li J, Yuan Z, Liu Y, Canavese F, Xu H. Risk factors associated with unsatisfactory hip function in children with late-diagnosed developmental dislocation of the hip treated by open reduction. Orthop Traumatol Surg Res. 2020 Nov;106(7):1373-1381. doi: 10.1016/j.otsr.2020.03.018. Epub 2020 Jun 19. **PMID:** 32571742 #### See Also Links **Label:** Smith's anesthesia for infants and children **URL:** https://pubs.asahq.org/anesthesiology/article/105/4/863/6744/Smith-s-Anesthesia-for-Infants-and-Children-7th **Label:** 6-Articular mobility in an African population. **URL:** https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1006136/ **Label:** 7-persistent joint laxity and congenital dislocation of the hip **URL:** https://boneandjoint.org.uk/article/10.1302/0301-620x.46b1.40 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006617 - Term: Hip Dislocation - ID: D000004204 - Term: Joint Dislocations - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000009139 - Term: Musculoskeletal Abnormalities - ID: D000000013 - Term: Congenital Abnormalities ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M2363 - Name: Developmental Dysplasia of the Hip - Relevance: HIGH - As Found: Developmental Dysplasia of the Hip - ID: M9694 - Name: Hip Dislocation, Congenital - Relevance: HIGH - As Found: Developmental Dysplasia of the Hip - ID: M1112 - Name: Surgical Wound - Relevance: LOW - As Found: Unknown - ID: M7385 - Name: Joint Dislocations - Relevance: LOW - As Found: Unknown - ID: M9693 - Name: Hip Dislocation - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M12096 - Name: Musculoskeletal Abnormalities - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000082602 - Term: Developmental Dysplasia of the Hip - ID: D000006618 - Term: Hip Dislocation, Congenital ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06439134 **Brief Title:** Evaluation Of The Chronic Effects Of Covıd-19 Infection On The Respiratory System **Official Title:** Evaluation Of The Chronic Effects Of Covıd-19 Infection On The Respiratory System By Pulmonary Ultrasound, Pulmonary Function Tests and Cytokine Level Measurement #### Organization Study ID Info **ID:** Inflammation and Post COVID-19 #### Organization **Class:** OTHER **Full Name:** Yeditepe University ### Status Module #### Completion Date **Date:** 2023-09-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-30 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-06-01 **Type:** ACTUAL #### Start Date **Date:** 2022-06-01 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-04-02 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Yeditepe University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The aim of this study is to evaluate whether there are chronic effects in the pulmonary system and systemic level in individuals in the post COVID19 period in order to elucidate the involvement of inflammation after recovery. In addition, a perspective on the utility of pulmonary function testing and pulmonary ultrasound in the evaluation of chronic effects and patient follow-up will is aimed to be provided. By measuring the protein levels of inflammatory markers along with the data abovementioned, a foresight regarding the long-term effects of the previous infection at both functional and immunological levels will be obtained, allowing us to evaluate the post-COVID period from different angles. Volunteers who recovered from COVID-19 and those who didn't have COVID-19 were compared by evaluating chest x-ray scores (CXR), lung ultrasound scores (LUSS), pulmonary function tests and inflammatory cytokine levels (TNF-α, IL-1, IL-6, IL-17A). **Detailed Description:** Objective: The aim of this study is to evaluate whether there are chronic effects in the pulmonary system and systemic level in individuals in the post COVID19 period in order to elucidate the involvement of inflammation after recovery. In addition, a perspective on the utility of pulmonary function testing and pulmonary ultrasound in the evaluation of chronic effects and patient follow-up will is aimed to be provided. By measuring the protein levels of inflammatory markers along with the data abovementioned, a foresight regarding the long-term effects of the previous infection at both functional and immunological levels will be obtained, allowing us to evaluate the post-COVID period from different angles. Materials and Methods: Volunteers who recovered from COVID-19 infection at least 3 months or more were included in the study, while healthy volunteers who did not have the infection were enrolled as the control group. Two groups were compared by evaluating chest x-ray scores (CXR), lung ultrasound scores (LUSS), pulmonary function tests and inflammatory cytokine levels (TNF-α, IL-1, IL-6, IL-17A). ### Conditions Module **Conditions:** - Post-COVID-19 Syndrome - COVID-19 **Keywords:** - COVID-19 - Post-COVID-19 Syndrome - Pulmonary Ultrasound - Chest X-ray - Respiratory Function Test ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ACTUAL **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Year ### Arms Interventions Module #### Arm Group 1 **Description:** The group which consists of volunteers who has not been infected by COVID-19 virus **Intervention Names:** - Diagnostic Test: Pulmonary Ultrasound, Respiratory Function Test **Label:** Non-COVID-19 group #### Arm Group 2 **Description:** The group which consists of volunteers who has been infected by COVID-19 virus and has at least 3 months or more post-COVID period **Intervention Names:** - Diagnostic Test: Pulmonary Ultrasound, Respiratory Function Test **Label:** Post COVID-19 group ### Interventions #### Intervention 1 **Arm Group Labels:** - Non-COVID-19 group - Post COVID-19 group **Description:** Volunteers underwent pulmonary ultrasound and respiratory function test **Name:** Pulmonary Ultrasound, Respiratory Function Test **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Pulmonary Ultrasound is going to be made and evaluated by using LUSS score. LUSS score is an evlatuation score for pulmonary ultrasound. For the study, both hemithoraces of the patient will divided into eight areas in total. The evaluation is going to be performed in the right hemithorax upper anterior, right hemithorax lower anterior, right hemithorax upper lateral, right hemithorax lower lateral, left hemithorax upper anterior, left hemithorax lower anterior, left hemithorax upper lateral, and left hemithorax lower lateral regions, respectively. During the assessment, the researcher is going to be positioned on the right side of the patient for the right hemithorax assessment and on the left side for the left hemithorax assessment. Each area will be scored between 0-3 and for final score, score for each zone will be collected . 24 is the worst score and 0 is the best score. **Measure:** Pulmonary Ultrasound **Time Frame:** 1 month **Description:** Respiratory Function Test results are going to be recorded. The recorded values will be FEV1, FVC, FEV1/FVC, PEF, FRC and TLC values. **Measure:** Respiratory Function Test **Time Frame:** 1 month **Description:** Chest X-ray evaluation is going to be made according to CXR score. During the evaluation of chest radiography, the pulmonary parenchyma is going to be divided into a total of six regions as right/left and apical region/mid region/basal region. Post COVID-19 changes are going to be taken into consideration when scoring criteria is made; 0- No abnormal findings 1. Interstitial infiltrates (Septal thickening and focal or extensional opacity) 2. Interstitial and alveolar infiltrates (Interstitial predominant) 3. Interstitial and alveolar infiltrates (Alveolar predominance) The criteria looked at as A points will be scored. Each zone is going to be evaluated with a score defined as A score and the scores of each zone is going to be summed to obtain a total score. Thus, each radiograph will be given a score between 0-18 by scoring all six defined zones and an evaluation will be made. **Measure:** Chest X-ray Evaluation **Time Frame:** 1 month **Description:** Blood Cytokine Result Analysis is going to be made by Cytokine-Bead Array. The measured cytokines will be TNF-α, IL-1, IL-6 and IL-17A **Measure:** Blood Cytokine Result Analysis **Time Frame:** 1 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria:For the control group; * Age range: 18-60 years old * Not having had COVID-19 infection * (For female patients) No pregnancy or puerperium * Consent for the study * To be able to complete the pulmonary function test successfully * Vital signs at the stage of lung ultrasound or pulmonary function testing during the study no change in findings * Not having an active infection at the time of the workplace examination * No abnormal findings in the chest radiograph taken before the study * Absence of existing autoimmune or rheumatological disorders For the experimental group; * Age range: Being between 18-60 years old * Having had COVID-19 infection and post infectious period of 3 months or more to be * (For female patients) No pregnancy or puerperium * Consent for the study * To be able to complete the pulmonary function test successfully * Vital signs at the stage of lung ultrasound or pulmonary function testing during the study no change in findings * Not having an active infection at the time of the workplace examination * Abnormal findings on chest radiography taken in the pre-infectious period before the study absence of * Absence of existing autoimmune or rheumatological disorders Exclusion Criteria: * Age range: Being outside the 18-60 age range * (for the experimental group) COVID-19 infection and 3 days of post infectious period under the month * (For female patients) Pregnancy or puerperium * Lack of consent for the study * Failure to complete the pulmonary function test (dizziness, incompatibility, etc.) reasons) * Vital signs at the stage of lung ultrasound or pulmonary function testing during the study change in findings * Having an active infection at the time of the workplace examination * Abnormal chest radiographs taken in the pre-infectious period before the study the presence of findings * Existing autoimmune or rheumatological disease **Healthy Volunteers:** True **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** The applicants was selected beneath the emplyees of Zonguldak Obstetrics and Gynecology Hospital. The sample was formed by retrospective screening of patient records. (sample size: 372). There are two groups in the study, ones who had COVID-19 infection previously (N:50) and ones who didn't have COVID-19 infection. There was no gender discrimination in randomization. ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Yeditepe University ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007239 - Term: Infections - ID: D000011024 - Term: Pneumonia, Viral - ID: D000011014 - Term: Pneumonia - ID: D000012141 - Term: Respiratory Tract Infections - ID: 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 - Abbrev: Rare - Name: Rare 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: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M13904 - Name: Pneumonia - Relevance: LOW - As Found: Unknown - ID: M13914 - Name: Pneumonia, Viral - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M20490 - Name: Coronavirus Infections - Relevance: LOW - As Found: Unknown - ID: M6555 - Name: Coronaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M23685 - Name: Nidovirales Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000086382 - Term: COVID-19 ### Intervention Browse Module - Browse Branches - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21137 - Name: Respiratory System Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06439121 **Acronym:** Pain **Brief Title:** The 4-7-8 Breathing Technique on Pain and Nausea-Vomiting **Official Title:** Effect of the 4-7-8 Breathing Technique on Pain and Nausea-Vomiting in Patients After Bariatric Surgery #### Organization Study ID Info **ID:** PAINVOMIT #### Organization **Class:** OTHER **Full Name:** Ankara Yildirim Beyazıt University ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-30 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-03 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ankara Yildirim Beyazıt University #### Responsible Party **Investigator Affiliation:** Ankara Yildirim Beyazıt University **Investigator Full Name:** Eda Özyürek **Investigator Title:** Ankara Yildirim Beyazıt University **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is planned as a randomized controlled trial to determine the effect of the 4-7-8 breathing technique applied to patients after bariatric surgery on pain and nausea and vomiting. The research will be conducted on 60 patients who underwent bariatric surgery between 05.2024-12.2024. Randomization will be ensured for students who meet the inclusion criteria, and they will be divided into two random groups: the experimental group (n=30) and the control group (n=30). After obtaining consent with the "Informed Consent Form," patients who agree to participate in the study will have the "Patient Introduction Form" filled out by researchers, and they will be provided with training on the 4-7-8 breathing technique. Patients will be instructed to practice the 4-7-8 breathing technique once per hour (4 breaths) post-surgery. Pain and nausea-vomiting will be monitored at 0, 2, 6, 12, and 24 hours during their 24-hour hospital stay. The control group, after consenting with the "Informed Consent Form" the day before surgery, will have the "Patient Introduction Form" filled out by researchers, and their pain and nausea-vomiting status will be monitored at the same intervals during their hospital stay. No interventions will be made for the control group; they will receive routine nursing care during their hospital stay. **Detailed Description:** Obesity is a significant health issue globally, ranking second among preventable causes of death (Güven, Akyolcu 2020). According to the World Health Organization (WHO) data for 2022, more than 2.5 billion adults are overweight, and 890 million are obese. It is known that 43% of adults (43% of men and 44% of women) are overweight (WHO, 2022). The severity of the situation in Turkey is highlighted in the World Health Organization report, where Turkey ranks first in Europe with a 32% obesity rate (WHO European Regional Obesity Report 2022). Obesity increases the risk of life-threatening diseases and chronic conditions (WHO, 2006). In 2019, an estimated 5 million deaths occurred due to diseases caused by obesity, such as cardiovascular diseases, diabetes, cancers, neurological disorders, chronic respiratory diseases, and digestive disorders (Collaborators, G. B. D., \& Ärnlöv, 2020). Bariatric surgery is considered the most effective and permanent method for weight loss in obesity treatment (Güngör 2012). The role of nurses is crucial in preventing complications after bariatric surgery (cardiopulmonary complications, venous thromboembolism, anastomotic leakage, electrolyte imbalance) and providing appropriate care when complications occur. Additionally, nurses play a key role in other important aspects of care after bariatric surgery, such as pain management, wound care, drain monitoring, early mobilization, fluid monitoring, nutrition, nausea-vomiting monitoring, continuous education, and psychosocial support (Yılmaz Güven, Arık, Çelik 2021). Pain caused by tissue damage in bariatric surgery patients, considered the fifth vital sign, should be carefully evaluated and recorded (Berk Özcan 2021). In a study by Steyer et al., it was found that nurses most commonly diagnosed pain in patients undergoing bariatric surgery (Steyer et al., 2016). Surgical pain that interferes with patients' physical movement and daily life activities can prolong the recovery process and lead to complications. Therefore, it is important to regularly assess pain levels with pain scales within the first 24 hours after surgery and manage pain accordingly (Usta 2014; Schulman and Thompson 2017). Postoperative nausea and vomiting in patients due to surgical intervention and anesthesia continue to be a common problem (Grindel and Grindel 2006; Varner KL, March AL 2020). Horizontal resection of the stomach, pressure applied by stapling and suturing lines to the stomach tissue, and the pressure applied to the abdomen by insufflation with CO2 during laparoscopic procedures in bariatric surgery increase the risk of postoperative nausea-vomiting (Aftab et al. 2019; Kushner et al. 2020). Post-bariatric surgery, especially within the first 24 hours, nausea and vomiting can be observed in 65% of patients (Ruhaiyem et al. 2016). The importance of performing correct and regular breathing exercises to minimize these problems is significant. Upon reviewing the literature, it is observed that there are a limited number of studies using the 4-7-8 Breathing Technique after bariatric surgery (Kurt Aktaş, Eskici İlgin 2023; Eskici İlgin, Yayla 2023). In one study, it was observed that the 4-7-8 Breathing Technique reduced the anxiety levels of patients after bariatric surgery (Kurt Aktaş, Eskici İlgin 2023). In another study, it was determined that the 4-7-8 breathing exercise reduced post-laparoscopic bariatric surgery pain and improved sleep quality (Eskici İlgin, Yayla 2023). Materials and Methods Study Design This research will be conducted using an experimental research model to determine the effect of the 4-7-8 breathing technique on pain and nausea-vomiting in patients after bariatric surgery. Population and Sample of the Study The population of the study will consist of patients who will undergo bariatric surgery admitted to the General Surgery Clinic of T.C. Ministry of Health Etlik City Hospital. There are 11 nurses working in the General Surgery Clinic where the research will be conducted, and it has a capacity of 22 beds. The sample of the study will consist of patients who underwent bariatric surgery between May 2024 and October 2024 and meet the criteria for participation in the study. The sample size was calculated using the G-power 3.1 program before the study, and based on the data of Doğan and Arslan (2022), with 80% power, 0.05 error, and 0.30 effect size, the sample size was determined as 46 patients. Considering the possibility of missing data, the sample will be increased by 30%, and thus, 60 patients will be included in the study. Patients who meet the research criteria will be assigned to the experimental and control groups in a 1:1 ratio by block randomization, using a computer program-generated (https://www.random.org) sequence. Inclusion criteria for the study: Being 18 years of age and older, and under 65 years of age, Undergoing laparoscopic general surgery under general anesthesia (such as laparoscopic sleeve gastrectomy, Laparoscopic Roux-en-Y gastric bypass), Being ASA Score I or II, Being willing to participate in the study Exclusion criteria for the study: Not undergoing laparoscopic surgical intervention, Having neurological or psychological problems, Transferred to the intensive care unit after surgery, Emergency and unplanned cases, Patients diagnosed with cancer will be excluded from the study. Data Collection Tools The patient identification form will be used to collect research data. This form consists of 3 sections. The first section will include sociodemographic characteristics consisting of 6 questions, including gender, age, BMI, education level, smoking status, and family history of obesity. The second section will include medical characteristics consisting of 7 questions, including the presence of chronic disease, ASA score, duration of stay under general anesthesia, type of surgery performed, history of surgical complications, and length of hospital stay. The third section will include 3 questions to evaluate pain and nausea-vomiting. Visual analog scale will be used to evaluate pain and nausea. The scale consists of a horizontal line 10 cm in length, and the distance between the far left end of the scale and the point marked by the patient determines the score. The score range from this scale is between 0-10, and higher scores indicate increased severity of the symptoms being evaluated. This scale can be used to evaluate various symptoms such as pain, anxiety, fatigue, nausea, vomiting. Vomiting will be evaluated as "present" or "absent". Ethics of the Study Permission obtained from the Ankara Yıldırım Beyazıt University Ethics Committee and the management of Etlik City Hospital where the study will be conducted. Patients will be informed about the research and their consent will be obtained. Data Evaluation IBM SPSS Statistics 23.0 software will be used for statistical analysis and calculations. Frequency distribution (number, percentage) will be provided for categorical variables, and descriptive statistics (mean, standard deviation) will be provided for numerical variables during data evaluation. The normal distribution status of the data will be evaluated using the Shapiro-Wilk test. In cases where the data does not follow a normal distribution, the Mann Whitney-U test and Spearman correlation analysis will be used to determine differences between the two groups. A significance level of p\<0.05 will be accepted. Data Collection For the experimental group, after obtaining permission with the "Informed Consent Form" the day before surgery, patients who agree to participate in the research will be provided with a "Patient Introduction Form" and will be given training on the 4-7-8 breathing technique. Patients will be instructed to apply the 4-7-8 breathing technique as 1 set (4 breaths) per hour after surgery. Pain and nausea-vomiting status will be monitored at 0, 2, 6, 12, and 24 hours during the 24-hour period of hospitalization. Holding the breath for a period helps renew the body's oxygen. The 4-7-8 breathing technique provides the oxygen support needed by organs and tissues and helps to expel CO2. In the 4-7-8 breathing technique, a breath is taken for 4 seconds, held for 7 seconds, and exhaled in 8 seconds (How to use the 4-7-8 breathing technique to reduce stress https://www.medicalnewstoday.com/articles/324417. March 22, 2024). For the control group, after obtaining permission with the "Informed Consent Form" the day before surgery, patients who agree to participate in the research will be provided with a "Patient Introduction Form". Pain and nausea-vomiting status will be monitored at 0, 2, 6, 12, and 24 hours during the 24-hour period of hospitalization. No intervention will be made for patients in the control group, and they will receive routine nursing care provided at the hospital. ### Conditions Module **Conditions:** - Pain - Vomiting - Nausea - Post Operative Pain - Vomiting, Postoperative - Nausea, Postoperative ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The Patient Introduction Form comprises three sections. The first section covers sociodemographic characteristics, including gender, age, BMI, education level, smoking status, and family history of obesity (6 questions). The second section addresses medical characteristics such as chronic diseases, ASA score, duration of general anesthesia, type of surgery, surgical complications history, and length of hospital stay (7 questions). The third section evaluates pain and nausea-vomiting using the Visual Analog Scale, a 10 cm horizontal line where patients mark their severity level. Scores range from 0-10, with higher scores indicating increased symptom severity. The scale is versatile, assessing symptoms like pain, anxiety, fatigue, and nausea-vomiting, with vomiting assessed as "present" or "absent." Patients will be taught the 4-7-8 breathing technique pre-surgery and asked to practice it post-surgery. Their responses to the third section's questions will be recorded. **Intervention Names:** - Procedure: 4-7-8 Breathing Technique **Label:** 4-7-8 Breathing Technique **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The Patient Introduction Form comprises three sections: 1. Sociodemographic characteristics, encompassing gender, age, BMI, education level, smoking status, and family history of obesity (6 questions). 2. Medical characteristics, including the presence of chronic diseases, ASA score, duration of general anesthesia, type of surgery performed, history of surgical complications, and length of hospital stay (7 questions). 3. Evaluation of pain and nausea-vomiting using the Visual Analog Scale, which entails a 10 cm horizontal line where patients mark their severity level. Scores range from 0-10, with higher scores indicating increased symptom severity. Vomiting will be assessed as "present" or "absent." Patients in the control group will undergo routine monitoring and treatments without interventions, and their responses to the questions from the third section will be recorded. **Label:** Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - 4-7-8 Breathing Technique **Description:** Patients will be instructed to practice the 4-7-8 breathing technique once per hour (4 breaths) post-surgery. Pain and nausea-vomiting will be monitored at 0, 2, 6, 12, and 24 hours during their 24-hour hospital stay. **Name:** 4-7-8 Breathing Technique **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** During the 24-hour hospital stay, the patient's pain level will be assessed at 0, 2, 6, 12, and 24 hours, and the pain intensity, ranging from 0 for no pain to 10 for severe pain, as indicated by the patient, will be recorded. **Measure:** Pain Scale **Time Frame:** just before operation, just after operation **Description:** During the 24-hour hospital stay, the patient's nausea level will be observed at 0, 2, 6, 12, and 24 hours, and the occurrence of vomiting, noted as either present or absent, will be recorded. **Measure:** Vomitting **Time Frame:** just before operation, just after operation **Description:** During the 24-hour hospital stay, the patient's nausea level will be assessed at 0, 2, 6, 12, and 24 hours, and the severity of nausea, ranging from 0 for no nausea to 10 for severe nausea as indicated by the patient, will be recorded. **Measure:** Nausea **Time Frame:** just before operation, just after operation ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Being aged 18 and above, and under 65 years old * Patients undergoing laparoscopic general surgery under general anesthesia (such as laparoscopic sleeve gastrectomy, Laparoscopic Roux-en-Y gastric bypass) will be included in the study. * Having an ASA Score of I or II * Being willing to participate in the study Exclusion Criteria: * Not undergoing laparoscopic surgical intervention, * Having neurological or psychological issues, * Transferred to the intensive care unit after surgery, * Emergency and unplanned cases, * Patients diagnosed with cancer will be excluded from the scope of the study. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** tyilmazer@aybu.edu.tr **Name:** Tuba Yilmazer, PhD **Phone:** 5079552804 **Role:** CONTACT **Contact 2:** **Email:** eda-ozyurek1907@hotmail.com **Name:** Eda Özyürek **Phone:** 5348374046 **Role:** CONTACT #### Locations **Location 1:** **City:** Yeni̇mahalle **Country:** Turkey **Facility:** Ankara YBU **State:** Ankara **Zip:** 6010 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012817 - Term: Signs and Symptoms, Digestive - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M13069 - Name: Pain, Postoperative - Relevance: HIGH - As Found: Post Operative Pain - ID: M17582 - Name: Vomiting - Relevance: HIGH - As Found: Vomiting - ID: M12273 - Name: Nausea - Relevance: HIGH - As Found: Nausea - ID: M27137 - Name: Respiratory Aspiration - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M22074 - Name: Postoperative Nausea and Vomiting - Relevance: HIGH - As Found: Vomiting, Postoperative - ID: M15622 - Name: Signs and Symptoms, Digestive - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009325 - Term: Nausea - ID: D000014839 - Term: Vomiting - ID: D000010149 - Term: Pain, Postoperative - ID: D000020250 - Term: Postoperative Nausea and Vomiting ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06439108 **Brief Title:** Single vs Double Symphyseal Plating in Management of Vertically Unstable Open Book Pelvic Ring Injuries: **Official Title:** Single Versus Double Symphyseal Plating in Management of Vertically Unstable Open Book Pelvic Ring Injuries: A Randomized Controlled Trial #### Organization Study ID Info **ID:** FMASU R65/2023 #### Organization **Class:** OTHER **Full Name:** Ain Shams University ### Status Module #### Completion Date **Date:** 2024-07-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-30 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-04-15 **Type:** ACTUAL #### Start Date **Date:** 2023-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-26 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ain Shams University #### Responsible Party **Investigator Affiliation:** Ain Shams University **Investigator Full Name:** Islam Moussa **Investigator Title:** lecturer of orthopedic surgery **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** compare functional, radiological outcomes, implant failure and the incidence of recurrent diastasis of single superior symphyseal plate versus double plating in management of vertically unstable open book injuries **Detailed Description:** The real algorithm was the necessity for double superior \& anterior plating versus single superior symphyseal plate in management of APC III pelvic ring injuries, whether the incidence of intraoperative and short-term postoperative complications, recurrent diastasis, radiological and functional outcomes differed between these two methods. Our hypothesis was that the use of an additional anterior symphyseal plating could provide a more rigid fixation, with less complications of recurrent diastasis or implant failure. Also it will be applied through the same incision without increasing the patient overall morbidity. ### Conditions Module **Conditions:** - Evaluation of Single Symphyseal Plating in APC III Injuries **Keywords:** - APC III pelvic ring injuries - single symphyseal plating - double symphyseal plating - functional outcome - Majeed pelvic score ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** An independent doctor created the randomization sequence using Excel 2016 (computerized random numbers) with a 1:1 allocation via random block sizes of 2, 4, and 6; he assigned the sample numbers equally to each group and assigned the block. Patients and physicians allocated to each intervention group were aware of the allocation; however, the data analysts and the outcome assessors were kept blinded to the allocation. The investigators prospectively carried out this study on 30 patients with APC III pelvic ring injuries between March 2022 and May 2023 that met our inclusion criteria. The independent doctor allocated the 30 cases to two groups: Group A (15 cases): single superior symphyseal plate, group B (15 cases): double superior \& anterior symphyseal plate ##### Masking Info **Masking:** DOUBLE **Masking Description:** Patients and physicians allocated to each intervention group were aware of the allocation; however, the data analysts and the outcome assessors were kept blinded to the allocation. **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 15 cases undergoing single superior symphyseal plate, reduction of the posterior ring was either closed reduction in SI joint dislocations \& fracture-dislocations and sacral fractures or open reduction in iliac wing fractures through the lateral window of the ilioinguinal approach.Anterior pelvic ring reduction and fixation was done via the classic Pfannenstiel approach **Intervention Names:** - Procedure: single symphyseal plating in management of vertically unsable open book pelvic ring injuries **Label:** single superior symphyseal plate **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** 15 cases undergoing double superior \& anterior symphyseal plates, 15 cases undergoing double superior \& anterior symphyseal plates, reduction of the posterior ring was either closed reduction in SI joint dislocations \& fracture-dislocations and sacral fractures or open reduction in iliac wing fractures through the lateral window of the ilioinguinal approach.Anterior pelvic ring reduction and fixation was done via the classic Pfannenstiel approach **Intervention Names:** - Procedure: single symphyseal plating in management of vertically unsable open book pelvic ring injuries **Label:** double superior & anterior symphyseal plates **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - double superior & anterior symphyseal plates - single superior symphyseal plate **Description:** open book pelvic ring injuries can be managed via the two techniques. **Name:** single symphyseal plating in management of vertically unsable open book pelvic ring injuries **Other Names:** - double symphyseal plating in management of vertically unsable open book pelvic ring injuries **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** clinical assessment by Majeed pelvic scoring system evaluated and calculated at each follow-up visit with the mean value presented **Measure:** Rate of Excellent, Good, Fair or Poor clinical outcome **Time Frame:** 1 year postoperative **Description:** Radiological assessment using Matta \& Tornetta radiological principles via plain x-ray pelvis showing both hips: anteroposterior, inlet and outlet views \& CT pelvis if available; we evaluated five criteria on X-ray films postoperatively: residual posterior displacement, vertical displacement, pubic symphyseal translation, sagittal rotation, and gapping of the sacroiliac joint; according to the grading of Matta and Tornetta, we classified the results into Excellent (less than or equal 4 mm), Good (4-10 mm), Fair (10-20 mm), and Poor (more than 20 mm). **Measure:** Rate of Excellent, Good, Fair or Poor radiological outcome **Time Frame:** 1 year postoperative **Description:** rate of symphyseal translation was measured \& compared between the two study groups **Measure:** Rate of recurrent diastasis **Time Frame:** throughout study completion, average one year postoperative #### Secondary Outcomes **Description:** The mean blood loss was calculated in milliliters and compared between the two study groups, it was measured intraoperative and postoperative from suction drains **Measure:** Mean intraoperative blood loss **Time Frame:** up to 5 days post-operative **Description:** The mean operation time was calculated in minutes and compared between the two study groups **Measure:** Mean operative time **Time Frame:** It was calculated intra-operative **Description:** We focused the evaluation of Postoperative complications on the local complications related to fixation principles and technique: LLD, implant failure, wound infection, residual malunion or non-union of the anterior ring, and loss of reduction (2ry SI dislocation or any rotational or vertical re-displacement) **Measure:** postoperative complications' rate **Time Frame:** 1 year post-operative ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Anterior ring symphyses diastasis * Tile C pelvic ring injuries * Age between 16-60 years' old Exclusion Criteria: * Tile B pelvic ring injuries * Isolated bony fractures of the anterior pelvic ring * Open fractures * Age less than 14 years and older than 60 years * Associated internal organ injuries that require definitive intervention **Healthy Volunteers:** True **Maximum Age:** 60 Years **Minimum Age:** 16 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Islam Sayed Moussa **State:** Abassia **Zip:** 1234 #### Overall Officials **Official 1:** **Affiliation:** no funding recieved **Name:** Islam S Moussa, MD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Access Criteria:** full access **Description:** share the plan **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** 1 year ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M17685 - Name: Wounds and Injuries - Relevance: HIGH - As Found: Injury ### Condition Browse Module - Meshes - ID: D000014947 - Term: Wounds and Injuries ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06439095 **Brief Title:** Interleukin-2 (IL-2), Interleukin-5 (IL-5) and Interleukin-17 (IL-17) Levels of Patients With Stainless Steel Crowns **Official Title:** Evaluation of IL-2, IL-5 and IL-17 Expression Levels in Saliva of Patients Treated With Stainless Steel Crowns #### Organization Study ID Info **ID:** YYU-BAVCI-01 #### Organization **Class:** OTHER **Full Name:** Yuzuncu Yıl University ### Status Module #### Completion Date **Date:** 2024-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Yuzuncu Yıl University #### Responsible Party **Investigator Affiliation:** Yuzuncu Yıl University **Investigator Full Name:** Burçin AVCI **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of this study is to investigate whether nickel hypersensitivity following stainless steel crown treatment in children aged 7-13 leads to an increase in IL-2, IL-5, and IL-17 levels by analyzing saliva samples. By doing so, the study seeks to prevent potential hypersensitivity reactions after stainless steel crown treatment. The main question it aims to answer is: Which interleukin level increases in the controls 1 week after stainless steel crowns are applied? Researchers will investigate whether there is a significant increase in interleukin levels in children's saliva before and after the procedure. Participants will: They will provide saliva samples before stainless steel crowns are applied They will visit the clinic after 1 week for check-ups and tests. **Detailed Description:** Expression levels of IL-2, IL-5 and IL-17 in the saliva of individuals aged 7-13 years who underwent stainless steel crown will be recorded before and after the procedure. Before the saliva sample collection procedure, the patient will be asked to rinse their mouth with sterile water and then spit into sterile plastic cups. After collecting approximately 3 ml of saliva, the saliva will be transferred to appropriate eppendorfs and stored at -40 degrees Celsius. For the second post-procedure, the same algorithms will be applied for saliva collection seven days after the crown procedure. Also ph value and ion levels of saliva will be measured ### Conditions Module **Conditions:** - Saliva - Dental Crown **Keywords:** - Saliva - Dental crown - Gene expression ### Design Module #### Bio Spec **Description:** Saliva of patients using stainless steel crown **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** CASE_CROSSOVER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 12 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Salivary IL-2, IL-5 and IL-17 expression levels of patients will be recorded **Intervention Names:** - Genetic: Salivary Collection - Diagnostic Test: Ph and ion level measurement of saliva **Label:** Patients prior to placement of stainless steel crowns #### Arm Group 2 **Description:** Salivary IL-2, IL-5 and IL-17 expression levels of patients will be recorded **Intervention Names:** - Genetic: Salivary Collection - Diagnostic Test: Ph and ion level measurement of saliva **Label:** Follow-up patients after placement of stainless steel crowns ### Interventions #### Intervention 1 **Arm Group Labels:** - Follow-up patients after placement of stainless steel crowns - Patients prior to placement of stainless steel crowns **Description:** Expression levels of IL-2, IL-5 and IL-17 in the saliva of individuals aged 7-13 years who underwent stainless steel crown will be recorded before and after the procedure. Before the saliva sample collection procedure, the patient will be asked to rinse their mouth with sterile water and then spit into sterile plastic cups. After collecting approximately 3 ml of saliva, the saliva will be transferred to appropriate eppendorfs and stored at -40 degrees Celsius. For the second post-procedure, the same algorithms will be applied for saliva collection seven days after the crown procedure. **Name:** Salivary Collection **Type:** GENETIC #### Intervention 2 **Arm Group Labels:** - Follow-up patients after placement of stainless steel crowns - Patients prior to placement of stainless steel crowns **Description:** Salivary concentration of nickel, chrome, cobalt and palladium ions will be measured using an atomic absorption spectrophotometer. Salivary pH will be measured with the help of a digital pH meter **Name:** Ph and ion level measurement of saliva **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Relative gene expression analysis will be performed. Quantitative polymerase chain reaction (qPCR) Master Mix will be used for this purpose. Primers to be used in polymerase chain reaction (PCR) analysis and their properties are given below. The total volume of each PCR reaction will be set to 25 µL consisting of 12.5 µL qPCR Master Mix, 1 µL forward and reverse primers, 6.5 µL ultrapure water and 5 µL complementary DNA (cDNA). In the first step of the PCR protocol, after an initial incubation step at 95 °C for 10 minutes, PCR cycles will be performed at 94 °C for 15 seconds and 60 °C for 30 seconds in 40 replicates. The threshold for gene expression analysis will be set as auto-detection. According to the housekeeping gene, IL-2, IL-5, IL-17 gene expression values will be determined. **Measure:** Level of salivary gene expression **Time Frame:** Sample collection during 1 day examination, approximately a week later second sample collection #### Secondary Outcomes **Description:** Salivary concentration of nickel, chrome, cobalt and palladium ions will be measured using an atomic absorption spectrophotometer **Measure:** Level of salivary ions **Time Frame:** Sample collection during 1 day examination, approximately a week later second sample collection **Description:** Salivary pH will be measured with the help of a digital pH meter **Measure:** Level of salivary potential of hydrogen (pH) **Time Frame:** Sample collection during 1 day examination, approximately a week later second sample collection ### Eligibility Module **Eligibility Criteria:** \*\*Inclusion Criteria:\*\* * Patients with teeth requiring stainless steel crowns due to having caries on two or more surfaces. * Pediatric patients between 7-13 years old \*\*Exclusion Criteria:\*\* * Patients having any dental materials, such as fillings, fissure sealants, root canal treatments, or space maintainers * Patients with known allergies to various foods and materials. * Patients with systemic diseases that affect the immune system. * Patients with a history of chemotherapy or radiotherapy. **Maximum Age:** 13 Years **Minimum Age:** 7 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD **Study Population:** The patients living in Van city ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** burcinavci@yyu.edu.tr **Name:** Burçin Avcı, DDS, MSc **Phone:** 4322251744 **Role:** CONTACT #### Locations **Location 1:** **City:** Van **Contacts:** ***Contact 1:*** - **Email:** burcinavci@yyu.edu.tr - **Name:** Burçin Avcı, DDS, MSc - **Phone:** 4322251744 - **Role:** CONTACT ***Contact 2:*** - **Name:** Burçin Avcı, DDS, MSc - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Alaettin Koç, DDS, MSc - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Sema Kaya, DDS, PhD - **Role:** SUB_INVESTIGATOR **Country:** Turkey **Facility:** Yüzüncü Yil University **State:** Tuşba **Status:** RECRUITING **Zip:** 65080 #### Overall Officials **Official 1:** **Affiliation:** Yuzuncu Yıl University **Name:** Burçin Avcı, DDS, MSc **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: Analg - Name: Analgesics - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Micro - Name: Micronutrients ### Intervention Browse Module - Browse Leaves - ID: M10411 - Name: Interleukin-2 - Relevance: LOW - As Found: Unknown - ID: M6265 - Name: Cobalt - Relevance: LOW - As Found: Unknown - ID: M12472 - Name: Nickel - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06439082 **Acronym:** SPARKLE **Brief Title:** A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg/kg) Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises (SPARKLE) **Official Title:** A Phase III, Multicenter, Randomized, Placebo Controlled, Double-blind Study to Assess Efficacy and Safety of Crizanlizumab (5 mg/kg) Versus Placebo, With or Without Hydroxyurea/Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients With Frequent Vaso-Occlusive Crises #### Organization Study ID Info **ID:** CSEG101A2303 #### Organization **Class:** INDUSTRY **Full Name:** Novartis ### Status Module #### Completion Date **Date:** 2030-04-19 **Type:** ESTIMATED #### Expanded Access Info **Has Expanded Access:** True **Status For NCT ID:** AVAILABLE #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2029-03-23 **Type:** ESTIMATED #### Start Date **Date:** 2024-10-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Novartis Pharmaceuticals #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** A phase III, multi-center, randomized, placebo-controlled, double-blind study to assess efficacy and safety of crizanlizumab (5 mg/kg) versus placebo, with or without hydroxyurea/hydroxycarbamide therapy, in adolescent and adult Sickle Cell Disease patients with frequent vaso-occlusive crises. **Detailed Description:** Study CSEG101A2303 (SPARKLE) is a Phase III, multicenter, randomized, double-blind study to assess efficacy and safety of crizanlizumab 5 mg/kg versus placebo, with or without hydroxyurea/ hydroxycarbamide therapy (HU/HC), in Sickle Cell Disease patients aged 12 years and older with frequent vaso-occlusive crises (4-12 events in 12 months prior to the screening visit). Participants will be randomized in a 2:1 ratio to the crizanlizumab 5 mg/kg or placebo treatment arm. Central randomization will be stratified by concomitant HU/HC usage (yes/no) and region (South America, North America, and sub-Saharan Africa) at baseline. ### Conditions Module **Conditions:** - Sickle Cell Disease **Keywords:** - Sickle Cell Disease - SCD - SEG101 - Crizanlizumab - Hydroxyurea/ Hydroxycarbamide Therapy - Vaso-Occlusive Crises - Sickle Cell Anemia - blood disorders - hemoglobin - red blood cells - sickle-like shape - mutation in hemoglobin gene - sickle-cell trait - sickle-cell crisis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** Double-blind Study **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 315 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants receive Crizanlizumab (SEG101) at 5.0 mg/kg and standard of care. **Intervention Names:** - Biological: Crizanlizumab **Label:** Crizanlizumab (SEG101) at 5.0 mg/kg **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants receive the placebo drug and standard of care. **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Crizanlizumab (SEG101) at 5.0 mg/kg **Description:** Crizanlizumab is supplied in single use 10 mL glass vials at a concentration of 10 mg/mL. One vial contains 100 mg of crizanlizumab. This is a concentrate for solution for IV infusion. **Name:** Crizanlizumab **Other Names:** - SEG101, Adakveo®, Ryverna® **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Placebo is supplied in single use 10 mL glass vials at a concentration of 0 mg/mL. This is a concentrate for solution for IV infusion. **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Vaso oclusive crisis (VOC) is defined as a pain crisis (acute onset of pain for which there is no other medically determined explanation other than vaso-occlusion) lasting for at least 4 hours which is treated as per local guidelines with standard of care therapy used to treat VOC. Acute chest syndrome (ACS), priapism and hepatic or splenic sequestration will be considered VOC in this study. VOCs included are those HCP-managed in a healthcare facility and HCP-managed via remote consultation. Annualized rate of VOC events = (Number of VOC events \* 365)/(number of days in the observation period). Observation period = time from date of randomization to minimum of (last dose date until treatment discontinuation + 27 days, date of initiation or discontinuation of HU/HC or L-Glutamine (or other therapies such as Voxelotor and erythropoietin therapies to treat SCD and/or to prevent/reduce VOCs), date of randomization + 365 days). **Measure:** Annualized rate of VOCs that are healthcare professional (HCP)-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) in each treatment arm **Time Frame:** 1 year #### Secondary Outcomes **Description:** VOCs can be categorized as those HCP-managed in a healthcare facility, HCP-managed via remote consultation, or self-managed without recommendations from HCP during the event. Annualized rate of VOC events = (Number of VOC events \* 365)/(number of days in the observation period). To capture VOC events that are self-managed, and in order to avoid VOC recall bias and to make sure the pain events are captured in real-time, a cloud-based application will be used and setup an account for each participant. **Measure:** The annualized rate of all VOCs including VOCs that are HCP-managed (either at a health care facility or via remote consultation) as well as those that are self-managed without recommendations from HCP during the event in each treatment arm **Time Frame:** 1 year **Description:** Vaso oclusive crisis (VOC) is defined as a pain crisis lasting for at least 4 hours which is treated as per local guidelines with standard of care therapy. Acute chest syndrome (ACS), priapism and hepatic or splenic sequestration will be considered VOC in this study. VOCs can be categorized as those HCP-managed in a healthcare facility, HCP-managed via remote consultation, or self-managed without recommendations from HCP during the event. Annualized rate of VOC is the number of VOC events during a year period. **Measure:** Annualized rate of VOC by subtype of management in each treatment arm over the planned 52-week period. **Time Frame:** 1 year **Description:** VOC is defined as a pain crisis lasting for at least 4 hours which is treated as per local guidelines with standard of care therapy. ACS, priapism and hepatic or splenic sequestration will be considered VOC in this study. VOCs included are those HCP-managed in a healthcare facility and HCP-managed via remote consultation. Time to first occurrence of VOC that is HCP-managed (either at a health care facility or via remote consultation) is defined as the time from the date of randomization to the date of the first occurrence of the VOC. **Measure:** The time to first VOC that is HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms. **Time Frame:** 1 year **Description:** To assess the number of participants free from VOCs leading to healthcare visit. VOC is defined as a pain crisis lasting for at least 4 hours which is treated as per local guidelines with standard of care therapy. ACS, priapism and hepatic or splenic sequestration will be considered VOC in this study. A participant is free from VOC if they do not have a VOC crisis. **Measure:** Proportion of participants free from VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) in each treatment arm over the planned 52-week treatment period. **Time Frame:** 1 year **Description:** VOC is defined as a pain crisis lasting for at least 4 hours which is treated as per local guidelines with standard of care therapy. ACS, priapism and hepatic or splenic sequestration will be considered VOC in this study. Duration of HCP-managed VOC is defined as end date of the VOC - start date of the VOC + 1 day. **Measure:** Duration of VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) in each treatment arm over the planned 52-week treatment period. **Time Frame:** 1 year **Description:** Immunogenicity: measurement of anti-drug antibodies (ADA) to crizanlizumab. **Measure:** Number of participants with anti-SEG101 (crizanlizumab) antibodies (any time) **Time Frame:** 2 years **Description:** Incidence and severity of AEs and SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs), and laboratory results qualifying and reported as AEs. **Measure:** Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) **Time Frame:** 2 years **Description:** Assessment of safety of SEG101 **Measure:** Absolute change from baseline in hemoglobin **Time Frame:** Baseline, 2 years ### Eligibility Module **Eligibility Criteria:** Key Inclusion Criteria: 1. Participants must be aged 12 years and older on the day of signing informed consent. Adolescents include participants aged 12 to \<18 years old and adults include participants aged 18 years and older. 2. Confirmed diagnosis of SCD by Hb electrophoresis or high-performance liquid chromatography (HPLC) (performed locally or by central laboratory if not available locally). All SCD genotypes are eligible. 3. Experienced 4 to 12 VOCs (refer to Section 8.3.1 for study definition of VOC) that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) within the 12 months prior to the screening visit. Baseline VOCs are determined by medical history and are required to be documented at source. 4. If the participant is on HU/HC, they must be taking it for at least 6 months and at stable dose for at least 3 months prior to the Screening visit and plan to continue taking it at the same dose and schedule until at least the participant has reached 52 weeks of the planned study treatment. Participants who have initiated HU/HC 6-12 months prior to the screening visit must have evidence of insufficient control of acute pain despite initiation. These participants must have a cumulative of 4-12 VOCs in the 12 months prior to the screening period, with at least 2 during the last 6 months while on HU/HC. If receiving erythropoietin stimulating agent, the participant must have been receiving the drug for at least 6 months prior to screening visit and plan to continue taking the drug at the same dose and schedule until the participant has reached 52 weeks of the planned study treatment. Participants who have not been receiving HU/HC, and/or erythropoietin stimulating agent must not have received it for at least 6 months prior to screening visit. Key Exclusion Criteria: 1. Fewer than 4 or more than 12 VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) within the 12 months prior to screening visit as determined by medical history and documented at source. 2. History of stem cell transplant and/or gene therapy. 3. Received blood products within 30 days prior to Week 1 Day 1 dosing. 4. Any documented history of a clinical stroke or intracranial hemorrhage, or an uninvestigated neurologic finding within the past 12 months before screening visit. Silent infarct only present on imaging is not excluded. 5. Participating in a chronic transfusion program (pre-planned series of transfusions for prophylactic purposes) and/or planning to undergo an exchange transfusion during the duration of the study; episodic transfusion in response to worsened anemia or VOC is permitted. 6. Contraindication or hypersensitivity to any drug or metabolites from similar class as study drug or to any excipients of the study drug formulation. History of severe hypersensitivity reaction to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction. **Minimum Age:** 12 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** novartis.email@novartis.com **Name:** Novartis Pharmaceuticals **Phone:** 1-888-669-6682 **Role:** CONTACT **Contact 2:** **Name:** Novartis Pharmaceuticals **Phone:** +41613241111 **Role:** CONTACT ### IPD Sharing Statement Module **Description:** Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com **IPD Sharing:** YES **URL:** https://www.clinicalstudydatarequest.com ## Derived Section ### Condition Browse Module - Ancestors - ID: D000000745 - Term: Anemia, Hemolytic, Congenital - ID: D000000743 - Term: Anemia, Hemolytic - ID: D000000740 - Term: Anemia - ID: D000006402 - Term: Hematologic Diseases - ID: D000006453 - Term: Hemoglobinopathies - ID: D000030342 - Term: Genetic Diseases, Inborn ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4085 - Name: Anemia, Sickle Cell - Relevance: HIGH - As Found: Sickle Cell Disease - ID: M4070 - Name: Anemia - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M15611 - Name: Sickle Cell Trait - Relevance: LOW - As Found: Unknown - ID: M9547 - Name: Hemolysis - Relevance: LOW - As Found: Unknown - ID: M4073 - Name: Anemia, Hemolytic - Relevance: LOW - As Found: Unknown - ID: M4075 - Name: Anemia, Hemolytic, Congenital - Relevance: LOW - As Found: Unknown - ID: M9539 - Name: Hemoglobinopathies - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: T5229 - Name: Sickle Cell Anemia - Relevance: HIGH - As Found: Sickle Cell Disease ### Condition Browse Module - Meshes - ID: D000000755 - Term: Anemia, Sickle Cell ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Analg - Name: Analgesics - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: AnSickAg - Name: Antisickling Agents ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M207501 - Name: Chrysarobin - Relevance: LOW - As Found: Unknown - ID: M9969 - Name: Hydroxyurea - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06439069 **Acronym:** BETTER-HF **Brief Title:** BMI-Driven Tolerability and Efficacy of Entresto in Heart Failure Patients **Official Title:** BMI-Driven Tolerability and Efficacy of Entresto in Heart Failure Patients #### Organization Study ID Info **ID:** LUHSKC- 405 #### Organization **Class:** OTHER **Full Name:** Lithuanian University of Health Sciences ### Status Module #### Completion Date **Date:** 2024-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-11-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-08-10 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Sligo General Hospital **Class:** UNKNOWN **Name:** KlaipÄ-da University #### Lead Sponsor **Class:** OTHER **Name:** Lithuanian University of Health Sciences #### Responsible Party **Investigator Affiliation:** Lithuanian University of Health Sciences **Investigator Full Name:** Ali Aldujeli **Investigator Title:** Consultant Cardiologist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study aims to determine if patients with higher BMI can tolerate higher doses of Entresto (sacubitril/valsartan) and experience better symptomatic and functional outcomes compared to patients with lower BMI. **Detailed Description:** This prospective cohort study will enroll heart failure patients with reduced ejection fraction (HFrEF) to evaluate the tolerability and efficacy of Entresto uptitration across different BMI categories (Normal weight, Overweight, Obese, and Very Obese). Primary outcomes include the maximum tolerable dose and incidence of adverse drug reactions. Secondary outcomes include changes in heart failure symptoms, functional capacity measured by the 6-minute walk test, hospitalization rates, and mortality. ### Conditions Module **Conditions:** - Heart Failure - Obesity **Keywords:** - Heart failure - Entresto - Obese - Sacubitril/Valsartan - BMI - Tolerability - Efficacy - NT-proBNP ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 340 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants with a BMI between 18.5 and 24.9. This group will serve as a reference for normal weight individuals, providing baseline data for comparison with higher BMI categories regarding the tolerability and efficacy of Entresto. **Label:** Normal Weight (BMI 18.5-24.9) #### Arm Group 2 **Description:** Participants with a BMI between 25 and 29.9. This group will assess the impact of being overweight on the tolerability and efficacy of Entresto in heart failure patients. **Label:** Overweight (BMI 25-29.9) #### Arm Group 3 **Description:** Participants with a BMI between 30 and 34.9. This group will evaluate the effects of obesity on the tolerability and efficacy of Entresto, providing insights into how increased body weight influences treatment outcomes. **Label:** Obese (BMI 30-34.9) #### Arm Group 4 **Description:** Participants with a BMI of 35 or higher. This group will explore the challenges and potential benefits of Entresto uptitration in very obese individuals, focusing on the highest BMI category. **Label:** Very Obese (BMI ≥ 35) ### Outcomes Module #### Primary Outcomes **Description:** This outcome measures the highest dose of Entresto that patients in each BMI category can tolerate without experiencing significant adverse drug reactions (ADRs). The dose will be recorded at the end of the titration period, which is expected to last up to 24 weeks. **Measure:** Maximum tolerable dose of Entresto achieved **Time Frame:** up to 24 weeks #### Secondary Outcomes **Description:** This outcome assesses the changes in heart failure symptoms based on the New York Heart Association (NYHA) classification at baseline and at 1 year follow-up visit. Improvement or worsening of symptoms will be tracked. **Measure:** Changes in Heart Failure Symptoms (NYHA Classification) **Time Frame:** up to 24 weeks **Description:** This outcome measures the distance walked during the 6-minute walk test (6MWT) at baseline and at 1 year follow-up visit. It evaluates the functional capacity and exercise tolerance of participants. **Measure:** Changes in Functional Capacity (6-Minute Walk Test Distance) **Time Frame:** up to 24 weeks **Description:** This outcome assesses changes in the quality of life related to heart failure symptoms, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Scores will be recorded at baseline and at 1 year follow-up visit. **Measure:** Changes in Quality of Life (KCCQ Score) **Time Frame:** up to 24 weeks **Description:** This outcome tracks the number of hospitalizations due to heart failure or related conditions during the study period. It provides an indicator of disease progression and treatment efficacy. **Measure:** Hospitalization Rates **Time Frame:** up to 24 weeks **Description:** This outcome measures the changes in B-type natriuretic peptide (BNP) or N-terminal pro b-type natriuretic peptide (NT-proBNP) levels, which are biomarkers for heart failure severity, at baseline and at 1 year follow-up visit. **Measure:** Changes in BNP/NT-proBNP Levels **Time Frame:** up to 24 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults aged 18 and older * Diagnosed with heart failure with reduced ejection fraction (HFrEF) (LVEF ≤ 35%) * Naïve to Entresto therapy or willing to switch from previous ACE inhibitor/ARB therapy * Ability to provide informed consent Exclusion Criteria: * Severe renal or hepatic impairment (e.g., eGFR \&lt; 30 mL/min/1.73m², severe liver disease) * History of angioedema * Pregnant or breastfeeding women * Patients with malignancies or other severe comorbid conditions * Non-compliance with medication regimen **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study includes adult patients diagnosed with heart failure with reduced ejection fraction (HFrEF) and left ventricular ejection fraction (LVEF) ≤ 40%. Participants are either naïve to Entresto therapy or willing to switch from previous ACE inhibitor/ARB therapy. They will be categorized into four BMI groups: Normal Weight (BMI 18.5-24.9), Overweight (BMI 25-29.9), Obese (BMI 30-34.9), and Very Obese (BMI ≥ 35). Exclusion criteria include severe renal (eGFR \&lt; 30 mL/min/1.73m²) or hepatic impairment, history of angioedema, pregnancy, breastfeeding, active malignancies, severe comorbid conditions, and non-compliance with medication regimens. The study aims to enroll approximately 340 participants, with about 85 in each BMI category. Participants will be recruited from multiple cardiology clinics and hospitals. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ali.aldujeli@kaunoklinikos.lt **Name:** Ali Aldujeli, MD., MSc **Phone:** +37064874874 **Role:** CONTACT #### Locations **Location 1:** **City:** Kaunas **Contacts:** ***Contact 1:*** - **Email:** ali.aldujeli@kaunoklinikos.lt - **Name:** Ali Aldujeli, MD., MSc - **Phone:** +37064874874 - **Role:** CONTACT **Country:** Lithuania **Facility:** Hospital of Lithuanian University of Health Sciences Kaunas Clinics **Status:** RECRUITING **Zip:** LT-50161 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M9421 - Name: Heart Failure - Relevance: HIGH - As Found: Heart Failure - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006333 - Term: Heart Failure ### Intervention Browse Module - Browse Branches - Abbrev: AnAg - Name: Antihypertensive Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M301 - Name: Valsartan - Relevance: LOW - As Found: Unknown - ID: M350410 - Name: Sacubitril and valsartan sodium hydrate drug combination - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06439056 **Brief Title:** Phase 1 Study Assessing the Pharmacokinetics of NEX-22A in Subjects With T2D **Official Title:** An Open, Single Ascending Dose, Phase 1 Study to Assess the Pharmacokinetics, Safety, and Tolerability of NEX-22A, a Subcutaneous Prolonged-release Injection, in Male and Female Participants With Type 2 Diabetes #### Organization Study ID Info **ID:** NEX-22-01 #### Organization **Class:** INDUSTRY **Full Name:** Nanexa AB ### Status Module #### Completion Date **Date:** 2024-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-31 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Profil Institut für Stoffwechselforschung GmbH #### Lead Sponsor **Class:** INDUSTRY **Name:** Nanexa AB #### 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 with the study is to assess pharmacokinetics of NEX-22A in patients with type 2 diabetes. **Detailed Description:** The trial is a single-centre, open-label, single ascending dose study. After being informed about the study and potential risks, all patients given written informed consent will undergo a screening to determine eligibility for study entry. Each subject will be enrolled in one of the three sequential cohorts, comprising one single dose of NEX-22A liraglutide injection. Each cohort will have a sentinel participant. NEX-22A will be administered in sequential cohorts. Before initiating a new dose cohort, safety, tolerability and PK data for all treated subjects must have been reviewed by the dose escalation committee. Blood samples for PK analysis will be withdrawn at specified timepoints over a period of 36 days ### Conditions Module **Conditions:** - Type 2 Diabetes **Keywords:** - Type 2 diabetes - PK study - Long acting injectable - Liraglutid - GLP-1 ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Single ascending dose study including 3 cohorts (3 patients/cohort). The subjects will be enrolled in the respective cohorts, starting with cohort 1. NEX-22A will be administered in a sentinel fashion within the cohorts. A single participant will be dosed first in every cohort. If there are no safety concerns as judged by the investigator, the remaining subjects will be dosed at least 10 days after the sentinel. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 9 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The trial is single ascending dose study where the dose is escalated depending on previous cohorts PK data. **Intervention Names:** - Drug: NEX-22A, a prolonged release formulation of liraglutide **Label:** Single dose of NEX-22-01 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Single dose of NEX-22-01 **Description:** NEX-22A, a prolonged release formulation of liraglutide **Name:** NEX-22A, a prolonged release formulation of liraglutide **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Blood samples will be collected in order to calculate a PK profile. Maximum observed plasma concentration (Cmax) **Measure:** To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes **Time Frame:** From administration of study drug until 36 days **Description:** Blood samples will be collected in order to calculate a PK profile. Time of occurrence of Cmax (Tmax) **Measure:** To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes **Time Frame:** From administration of study drug until 36 days **Description:** Blood samples will be collected in order to calculate a PK profile. occurrence of Area under the plasma concentration vs. time curve (AUC) from time 0 to 8 hours (AUC0-8h) **Measure:** To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes **Time Frame:** From administration of study drug until 36 days **Description:** Blood samples will be collected in order to calculate a PK profile. AUC from time 0 to 12 hours (AUC0-12h) **Measure:** To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes **Time Frame:** From administration of study drug until 36 days **Description:** Blood samples will be collected in order to calculate a PK profile. AUC from time 0 to 24 hours (AUC0-24h) **Measure:** To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes **Time Frame:** From administration of study drug until 36 days **Description:** Blood samples will be collected in order to calculate a PK profile. AUC from time 0 to 72 hours (AUC0-72h) **Measure:** To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes **Time Frame:** From administration of study drug until 36 days **Description:** Blood samples will be collected in order to calculate a PK profile. AUC from time 0 to 7 days (AUC0-7days) **Measure:** To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes **Time Frame:** From administration of study drug until 36 days **Description:** Blood samples will be collected in order to calculate a PK profile. AUC from 0 to time of last measurable plasma concentration (AUClast) **Measure:** To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes **Time Frame:** From administration of study drug until 36 days **Description:** Blood samples will be collected in order to calculate a PK profile. AUC from time 0 to infinity (AUCinf) **Measure:** To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes **Time Frame:** From administration of study drug until 36 days **Description:** Blood samples will be collected in order to calculate a PK profile. Terminal elimination half-life (T1/2) **Measure:** To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes **Time Frame:** From administration of study drug until 36 days #### Secondary Outcomes **Description:** Number of events.Descriptive individual data. **Measure:** Number of subjects with treatment-related adverse events a assessed by frequency **Time Frame:** From administration of study drug until 36 days **Description:** Seriousness of adverse events. Descriptive individual data. **Measure:** Number of subjects with treatment-related adverse events a assessed by seriouness **Time Frame:** From administration of study drug until 36 days **Description:** Intensity of adverse events. Descriptive individual data. **Measure:** Number of subjects with treatment-related adverse events a assessed by intensity **Time Frame:** From administration of study drug until 36 days **Description:** Relationship to study treatment. Descriptive individual data. **Measure:** Number of subjects with treatment-related adverse events a assessed by relationship to study treatment **Time Frame:** From administration of study drug until 36 days **Description:** Measured in mmHg after 10 minutes supine rest. Descriptive individual data. **Measure:** Number of subjects with a clinical significant change from baseline in the systolic blood pressure at 36 days **Time Frame:** From administration of study drug until 36 days **Description:** Measured in mmHg after 10 minutes supine rest. Descriptive individual data. **Measure:** Number of subjects with a clinical significant change from baseline in in the diastolic blood pressure at 36 days **Time Frame:** From administration of study drug until 36 days **Description:** Measured in ms in supine position after 5 minutes of rest using an ECG machine. Descriptive individual data. **Measure:** Number of subjects with a clinical significant change from baseline in the ECG parameter PQ/PR at 36 days **Time Frame:** From administration of study drug until 36 days **Description:** Measured in ms in supine position after 5 minutes of rest using an ECG machine. Descriptive individual data. **Measure:** Number of subjects with a clinical significant change from baseline in the ECG parameter QRS at 36 days **Time Frame:** From administration of study drug until 36 days **Description:** Measured in ms in supine position after 5 minutes of rest using an ECG machine. Descriptive individual data. **Measure:** Number of subjects with a clinical significant change from baseline in the ECG parameter QT at 36 days **Time Frame:** From administration of study drug until 36 days **Description:** Measured in ms in supine position after 5 minutes of rest using an ECG machine. Descriptive individual data. **Measure:** Number of subjects with a clinical significant change from baseline in the ECG parameter QTcB at 36 days **Time Frame:** From administration of study drug until 36 days **Description:** Measured in ms in supine position after 5 minutes of rest using an ECG machine. Descriptive individual data. **Measure:** Number of subjects with a clinical significant change from baseline in the ECG parameter heart rate at 36 days **Time Frame:** From administration of study drug until 36 days **Description:** Blood samples for the analysis of haematology parameters will be collected through venepuncture or an indwelling venous catheter. Descriptive individual data. **Measure:** Number of subjects with a clinical significant change from baseline in the haematology blood parameters measurements at 36 days **Time Frame:** From administration of study drug until 36 days **Description:** Blood samples for the analysis of clinical chemistry parameters will be collected through venepuncture or an indwelling venous catheter. Descriptive individual data. **Measure:** Number of subjects with a clinical significant change from baseline in the clinical chemistry blood laboratory measurements at 36 days **Time Frame:** From administration of study drug until 36 days **Description:** Blood samples for the analysis of coagulation parameters will be collected through venepuncture or an indwelling venous catheter. Descriptive individual data. **Measure:** Number of subjects with a clinical significant change from baseline in the coagulation blood laboratory measurements at 36 days **Time Frame:** From administration of study drug until 36 days **Description:** Blood samples for the analysis of plasma glucos will be collected through venepuncture or an indwelling venous catheter. Descriptive individual data. **Measure:** Number of subjects with a clinical significant change from baseline in plasma glucose measurement at 36 days **Time Frame:** From administration of study drug until 36 days **Description:** Physical examination including assessment of the head. Descriptive individual data. **Measure:** Number of subjects with a clinical significant change from baseline in the physical examination of the head at 36 days **Time Frame:** From administration of study drug until 36 days **Description:** Physical examination including assessment of the eyes. Descriptive individual data. **Measure:** Number of subjects with a clinical significant change from baseline in the physical examination of the eyes at 36 days **Time Frame:** From administration of study drug until 36 days **Description:** Physical examination including assessment of the ears. Descriptive individual data. **Measure:** Number of subjects with a clinical significant change from baseline in the physical examination of the ears at 36 days **Time Frame:** From administration of study drug until 36 days **Description:** Physical examination including assessment of the nose. Descriptive individual data. **Measure:** Number of subjects with a clinical significant change from baseline in the physical examination of the nose at 36 days **Time Frame:** From administration of study drug until 36 days **Description:** Physical examination including assessment of the throat. Descriptive individual data. **Measure:** Number of subjects with a clinical significant change from baseline in the physical examination of the throat at 36 days **Time Frame:** From administration of study drug until 36 days **Description:** Physical examination including assessment of the skin and mucosae. Descriptive individual data. **Measure:** Number of subjects with a clinical significant change from baseline in the physical examination of the skin and mucosae at 36 days **Time Frame:** From administration of study drug until 36 days **Description:** Physical examination including assessment of the tyroid. Descriptive individual data. **Measure:** Number of subjects with a clinical significant change from baseline in the physical examination of the tyroid at 36 days **Time Frame:** From administration of study drug until 36 days **Description:** Physical examination including assessment of the neurological status. Descriptive individual data. **Measure:** Number of subjects with a clinical significant change from baseline in the physical examination of the neurological status at 36 days **Time Frame:** From administration of study drug until 36 days **Description:** Physical examination including assessment of the lungs. Descriptive individual data. **Measure:** Number of subjects with a clinical significant change from baseline in the physical examination of the lungs at 36 days **Time Frame:** From administration of study drug until 36 days **Description:** Physical examination including assessment of the cardiovascular system including inspection, palpation, and auscultation.Descriptive individual data. **Measure:** Number of subjects with a clinical significant change from baseline in the physical examination of the cardiovascular system at 36 days **Time Frame:** From administration of study drug until 36 days **Description:** Physical examination including palpation of the gastrointestinal system incl mouth check. Descriptive individual data. **Measure:** Number of subjects with a clinical significant change from baseline in the physical examination of the gastrointestinal system incl mouth at 36 days **Time Frame:** From administration of study drug until 36 days **Description:** Physical examination including palpation of the lymfh nodes. Descriptive individual data. **Measure:** Number of subjects with a clinical significant change from baseline in the physical examination of the lymfh nodes incl mouth at 36 days **Time Frame:** From administration of study drug until 36 days **Description:** Physical examination of the musculoskeletal system. Descriptive individual data. **Measure:** Number of subjects with a clinical significant change from baseline in the musculoskeletal system at 36 days. **Time Frame:** From administration of study drug until 36 days **Description:** Visual inspection. Descriptive individual data. **Measure:** Number of subjects with a clinical significant change from baseline in local tolerability i.e skin reactions assessed by visual inspection. **Time Frame:** From administration of study drug until 36 days **Description:** Photography of injection site Descriptive individual data. **Measure:** Number of subjects with a clinical significant change from baseline in local tolerability i.e skin reactions assessed by photography. **Time Frame:** From administration of study drug until 36 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Signed and dated informed consent obtained before any trial-related activities. Trial-related activities are any procedures that would not have been done during normal management of the subject. 2. Male or female subject with type 2 diabetes mellitus. 3. Metformin therapy without change in dose for the last 3 months. 4. Age between 18 and 65 years, both inclusive. 5. Body Mass Index (BMI) between 18.5 and 35.0 kg/m\^2, both inclusive. 6. HbA1c \&gt; 6.5% and \&lt;= 9.0%. 7. Diabetes duration of at least 1 year. Exclusion Criteria: 1. Known or suspected hypersensitivity to the IMP or any of the excipients or to any component of the IMP formulation. 2. Previous participation in this trial. Participation is defined as being dosed. 3. Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before enrolment in this trial. 4. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction. 5. Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the investigator. 6. Clinically relevant comorbidity, capable of constituting a risk for the subject when participating in the trial or of interfering with the interpretation of data. 7. Signs of acute illness as judged by the investigator. 8. Any serious systemic infectious disease during four weeks prior to first dosing of the trial drug, as judged by the investigator. 9. Subjects with dermatological conditions, tattoos or large scars on the abdomen that would limit the evaluation of local tolerability, as judged by the investigator. 10. Clinically significant abnormal values for haematology, biochemistry, coagulation, or urinalysis at screening as judged by the investigator. 11. Systolic blood pressure \&lt; 90 mmHg or \&gt;160 mmHg and/or diastolic blood pressure \&lt; 50 mmHg or \&gt; 95 mmHg at screening (one repeat test will be acceptable in case of suspected white-coat hypertension). 12. Heart rate at rest (as measured in vital sign assessment at screening) outside the range of 50-90 beats per minute. 13. Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening, as judged by the investigator. 14. Proliferative retinopathy or maculopathy as judged by the investigator based on a recent (\&lt;1.5 years) ophthalmologic examination. 15. Severe neuropathy, in particular autonomic neuropathy, as judged by the investigator. 16. Former or current use of liraglutide or any other GLP-1 receptor agonists (exenatide, semaglutide) except for the use in clinical trials. 17. Current use of any insulin or sulfonylureas. 18. Significant history of alcoholism or drug abuse as judged by the investigator or consuming more than 24.0 grams alcohol/day (for males), 12.0 grams alcohol/day (for females) on average. 19. A positive result in the alcohol and/or urine drug screen at the screening visit. 20. Smoking more than 5 cigarettes or the equivalent per day. 21. Inability or unwillingness to refrain from smoking and use of nicotine substitute products one day before and during the inpatient period. 22. Tested positive for hepatitis Bs antigen. 23. Tested positive for hepatitis C antibodies. (Presence of hepatitis C antibodies will not lead to exclusion if liver function tests are normal and a hepatitis C polymerase chain reaction is negative). 24. Positive result to the test for HIV-1/2 antibodies or HIV-1 antigen. 25. Any medication (prescription and non-prescription drugs) within 14 days before IMP administration and/or anticoagulant therapy. 26. Blood donation or blood loss of more than 500 mL within the last 3 months. 27. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation. 28. Committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. 29. Women of childbearing potential. 30. Trial site personnel directly affiliated with this trial and their immediate families (spouse, biological or legal guardian, child, or sibling). 31. The investigator considers a subject as unsuitable for inclusion in the trial for any other reason. Explanatory note on Exclusion Criterion 25: Exceptions are stable doses of metformin, SGLT2-blockers, low dose aspirin, antihypertensives, statins, thyroid hormones or occasional use of paracetamol or ibuprofen, and ,if female, with the exception of menopausal hormone replacement therapy. Explanatory note on Exclusion Criterion 29: A woman is considered of childbearing potential following menarche and until becoming postmenopausal unless permanently sterile due to hysterectomy, or bilateral salpingectomy, or bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** info@nanexa.se **Name:** David Westberg CEO **Phone:** + 46 (0)18-10 03 00 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003920 - Term: Diabetes Mellitus - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: HIGH - As Found: Type 2 Diabetes - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003924 - Term: Diabetes Mellitus, Type 2 ### Intervention Browse Module - Ancestors - ID: D000097789 - Term: Glucagon-Like Peptide-1 Receptor Agonists - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000054795 - Term: Incretins - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M419 - Name: Liraglutide - Relevance: HIGH - As Found: Due - ID: M26997 - Name: Glucagon-Like Peptide 1 - Relevance: LOW - As Found: Unknown - ID: M9043 - Name: Glucagon - Relevance: LOW - As Found: Unknown - ID: M3401 - Name: Glucagon-Like Peptide-1 Receptor Agonists - Relevance: LOW - As Found: Unknown - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown - ID: M27905 - Name: Incretins - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000069450 - Term: Liraglutide ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06439043 **Acronym:** EMDR **Brief Title:** Cultural Adaptation of EMDR for Major Depressive Disorder and Compaire Its Online and Face-to-Face Testing **Official Title:** Developing a Culturally and Methodologically Adapted EMDR Protocol for the Treatment of Major Depressive Disorder and Determining Its Efficacy by Testing it Through Online and Face-to-face Modes of EMDR Therapy #### Organization Study ID Info **ID:** 1213 #### Organization **Class:** OTHER **Full Name:** Khushal Khan Khattak Univeristy, Karak, Pakistan ### Status Module #### Completion Date **Date:** 2025-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Khushal Khan Khattak Univeristy, Karak, Pakistan #### Responsible Party **Investigator Affiliation:** University Malaysia Sarawak **Investigator Full Name:** Dr. Anwar Khan **Investigator Title:** PhD Student **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The present study aims to develop a culturally and methodologically adapted EMDR therapy protocol, determine its treatment fidelity, and then clinically test its efficacy in the treatment of Major Depressive Disorder in Pakistan by utilizing both in-person and online modalities of EMDR therapy. **Detailed Description:** Background and Aim: Major Depressive Disorder(MDD) is a globally leading cause of disability. Currently, psychotherapies like Eye Movement Desensitization and Reprocessing(EMDR) and Cognitive Behavioral Therapy(CBT) are widely available. Since EMDR originated in the United States, it may not be completely appropriate for non-Western countries like Pakistan, necessitating possible modifications. Moreover, therapists have long practiced face-to-face EMDR, but recently, online EMDR modalities have emerged. Nonetheless, it is surprising that there is a dearth of research not only on adaptations of EMDR in Pakistan but also on testing its clinical efficacy, particularly its online modalities. Considering this, the present study aims to develop a culturally and methodologically adapted EMDR therapy protocol, and clinically evaluate its efficacy in treating MDD in Pakistan by comparatively administering it through in-person and online modalities. Methods: This study will employ a mixed mode Randomized Controlled Trial design with a consecutive sample of (n=90). Patients will be treated by using adapted EMDR therapy protocol. Patients will be randomly allocated to in-person and online modes of EMDR. Various qualitative methods and quantitative techniques will be employed to data. Conclusion: This study is likely to make significant contributions by delivering insights about how to develop culturally and methodologically adapted EMDR. This study will extend our knowledge about the comparative effectiveness of EMDR in Pakistan. ### Conditions Module **Conditions:** - Major Depressive Disorder **Keywords:** - EMDR, Major Depressive Disorder, Online Psychotherapy, Cultural Adaptations, Fidelity Analysis, Non-inferiority Analysis, Pakistan. ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The adapted EMDR treatment protocol will be administered both online and face-to-face. Patients will be randomly allocated to either the face-to-face mode or the online mode of EMDR at the same time. ##### Masking Info **Masking:** SINGLE **Masking Description:** It will be a single-blinded study in which only the participants will be unaware of certain aspects of the research design. Typically, this means that the participants will not know which treatment they are receiving or the mode of treatment (online or face-to-face), while the researchers administering the treatment and collecting data will be aware. **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The face-to-face Eye Movement Desensitization and Reprocessing (EMDR) therapy will be administered by the psychotherapist at their clinic. The treatment will consist of a total of 12 to 13 sessions, with one session conducted per week. **Intervention Names:** - Other: EMDR Psychotherapy **Label:** Face to Face Eye Movement Desensitization & Reprocessing Therapy **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The online Eye Movement Desensitization and Reprocessing (EMDR) therapy will be administered by the psychotherapist using BilateralBase software. The treatment will consist of 12 to 13 online sessions, with one session conducted per week. **Intervention Names:** - Other: Online EMDR Psychotherapy **Label:** Online Eye Movement Desensitization and Reprocessing therapy **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Face to Face Eye Movement Desensitization & Reprocessing Therapy **Description:** EMDR psychotherapy will be delivered in person by the psychotherapist to treat symptoms of Major Depressive Disorder, consisting of 12 weekly sessions. **Name:** EMDR Psychotherapy **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Online Eye Movement Desensitization and Reprocessing therapy **Description:** Online EMDR Psychotherapy will be delivered online by the psychotherapist to treat symptoms of Major Depressive Disorder, consisting of 12 weekly sessions. **Name:** Online EMDR Psychotherapy **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Major Depressive Disorder will be assess by Hamilton Depression rating scale with score more than 30 as cut off point **Measure:** Major Depressive Disorder **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. The patient should exhibit symptoms of Major Depressive Disorder. 2. Male and female patients will be chosen equally. 3. Patients between the ages of 20 and 50 will be selected. 4. Patients should preferable be "treatment-naïve," meaning they have no recent history of any psychotherapy or medication. Exclusion Criteria: a. There must be no significant neuropsychological or cognitive disorders among the patients **Gender Based:** True **Gender Description:** both male and female patients will be selected **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000001526 - Term: Behavioral Symptoms ### 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: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depressive Disorder - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depressive Disorder - ID: M7060 - Name: Depressive Disorder, Major - Relevance: HIGH - As Found: Major Depressive Disorder - ID: M21089 - Name: Facies - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003866 - Term: Depressive Disorder - ID: D000003863 - Term: Depression - ID: D000003865 - Term: Depressive Disorder, Major ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06439030 **Brief Title:** Mobile and Web-Based Healing Program on University Students Affected by Earthquakes **Official Title:** Examining the Impact of a Mobile and Web-Based Healing Program on University Students Affected by Earthquakes and Experiencing High Levels of Trauma #### Organization Study ID Info **ID:** FiratU-PSOYLAR-001 #### Organization **Class:** OTHER **Full Name:** Firat University ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-01-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Firat University #### Responsible Party **Investigator Affiliation:** Firat University **Investigator Full Name:** Pınar Soylar **Investigator Title:** Associate Professor, Head of Nursing Department **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This research is a randomized controlled study that will be conducted in an online environment. The study comprises five stages. The first stage, PREPARATION, involves obtaining ethical approval and permissions from universities, preparing data collection tools, and identifying scholarship recipients. The second stage is the development of the MOBILE AND WEB-BASED application. The third stage is the SITUATION ASSESSMENT stage. In this stage, the post-earthquake trauma level, coping skill level, emotional eating levels, and the status of healthy lifestyle behavior of students enrolled in the Nursing Departments of firat University, Osmaniye Korkut Ata University, and Ankara University will be determined using one of the quantitative data collection tools, PETLDS (Objectives 1, 2, 3, and 4). The fourth stage is the INTERVENTION stage, where the prepared training and applications will be implemented within the program (Objectives 5, 6, 7, and 8). The fifth stage is the EVALUATION stage, involving the collection of final test data and analysis. **Detailed Description:** The aim of this research is to investigate the effect of a mobile and web-based recovery program applied to university students affected by post-disaster earthquakes and with high trauma levels on their post-earthquake trauma level, coping skills, emotional eating situations and healthy lifestyle behaviors. This research is a randomized controlled study that will be conducted in an online environment. The population of the research consists of students continuing their education in the Nursing Departments of Osmaniye Korkut Ata University, Fırat University Faculty of Health Sciences, and Ankara University Faculty of Nursing. The Post-Earthquake Trauma Level Determination Scale (PETLDS) will be administered to the entire population. The sample of the research will be stratified according to those who score high on the PETLDS (52 points and above) for each of the three universities and will be weighted according to the number of nursing students. Using a random sampling method, students will be assigned to experimental and control groups. It is planned to include a total of 80 students in the study, with 40 in the experimental group and 40 in the control group. The study comprises five stages. The first stage, PREPARATION, involves obtaining ethical approval and permissions from universities, preparing data collection tools, and identifying scholarship recipients. The second stage is the development of the MOBILE AND WEB-BASED application. The third stage is the SITUATION ASSESSMENT stage. In this stage, the post-earthquake trauma level, coping skill level, emotional eating levels, and the status of healthy lifestyle behavior of students enrolled in the Nursing Departments of Fırat University, Osmaniye Korkut Ata University, and Ankara University will be determined using one of the quantitative data collection tools, PETLDS (Objectives 1, 2, 3, and 4). The fourth stage is the INTERVENTION stage, where the prepared training and applications will be implemented within the program (Objectives 5, 6, 7, and 8). The fifth stage is the EVALUATION stage, involving the collection of final test data and analysis. In the proposed project, quantitative data will be collected through the Post-Earthquake Trauma Level Determination Scale, Earthquake Coping Strategies Scale, Healthy Lifestyle Behaviors Scale, and Emotional Eating Scale. In this research project, psychosocial interventions will be implemented for students under the "Recovery Program" for a duration of 12 weeks. A mobile and web-based application program will be developed for the "Recovery Program", and all interventions will be conducted through this program. The Recovery Program will include activities such as screening of movies, laughter yoga, stress coping techniques training, progressive relaxation exercises, education on loss/grief processes, expressive art therapy applications, and training on healthy lifestyle behaviors. The proposed Project has a duration of 16 months and consists of 5 work packages. It is anticipated that the proposed project will have significant social, economic, and scientific impacts. It is thought that the mobile and web-based application program to be implemented in this research will create a social support environment for students, provide professional psychosocial support, support the rehabilitation of students, set an example for post-traumatic intervention programs with different groups in the future, and can be included in national / provincial disaster action plans. The fact that the sample consists of students continuing their education in the same field will enhance interaction among students and contribute to their awareness of what can be done after a disaster in the future, thus also contributing to the identity of healthcare personnel. Among the suggested broader impacts of the proposed project are the publication of results in SSCI/SCI-E indexed journals and the training of researchers based on the findings of the research. ### Conditions Module **Conditions:** - Trauma - Stress **Keywords:** - earthquake - Post-traumatic stress - Psychosocial support ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This is the group to which the interventions in the recovery program are applied. **Intervention Names:** - Behavioral: Recovery program **Label:** Recovery group **Type:** EXPERIMENTAL #### Arm Group 2 **Label:** Control Group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Recovery group **Description:** The practices included in the program are: Cinema Film Screening and Emotion/Thought Sharing, Laughter Yoga Practice, Stress Coping Techniques Training, Progressive Relaxation, Loss/Mourning Process Training, Expressive Art Therapy Practice, Healthy Lifestyle Behaviors Training. **Name:** Recovery program **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The scale developed by Tanhan and Kayri (2013) to quickly and easily evaluate PTSD symptoms in individuals, especially after the earthquake, consists of 20 items and 5 dimensions. These dimensions are Behavioral Problems, Excitatory Limitation, Affective, Cognitive Configuration and Sleep Problems. There are five-point Likert style expressions such as "I strongly disagree", "I slightly agree", "I moderately agree", "I strongly agree" and "I completely agree". Items 11 and 12 are reverse scored. The lowest score that can be obtained from the scale is 20 and the highest score is 100. Cronbach's alpha of the scale was found to be 0.87. Increasing scores from the scale indicate that individuals' level of exposure to earthquakes increases (Tanhan and Kayri, 2013). **Measure:** Post-Earthquake Trauma Level Determination Scale (PETLDS) **Time Frame:** At the end of week 1 **Description:** The scale developed by Tanhan and Kayri (2013) to quickly and easily evaluate PTSD symptoms in individuals, especially after the earthquake, consists of 20 items and 5 dimensions. These dimensions are Behavioral Problems, Excitatory Limitation, Affective, Cognitive Configuration and Sleep Problems. There are five-point Likert style expressions such as "I strongly disagree", "I slightly agree", "I moderately agree", "I strongly agree" and "I completely agree". Items 11 and 12 are reverse scored. The lowest score that can be obtained from the scale is 20 and the highest score is 100. Cronbach's alpha of the scale was found to be 0.87. Increasing scores from the scale indicate that individuals' level of exposure to earthquakes increases (Tanhan and Kayri, 2013). **Measure:** Post-Earthquake Trauma Level Determination Scale (PETLDS) **Time Frame:** At the end of week 12 **Description:** The scale, consisting of 16 items and 3 sub-dimensions, was developed by Yöndem and Eren (2008). **Measure:** Earthquake Stress Coping Strategies Scale (ESCSS) **Time Frame:** At the end of week 1 **Description:** The scale, consisting of 16 items and 3 sub-dimensions, was developed by Yöndem and Eren (2008). **Measure:** Earthquake Stress Coping Strategies Scale (ESCSS) **Time Frame:** At the end of week 12 #### Secondary Outcomes **Description:** Turkish validity Bahar et al. The scale made by has 52 items and six factors. These; spiritual development, interpersonal relationships, nutrition, physical activity, health responsibility and stress management. The overall score of the scale gives the score for healthy lifestyle behaviors. All items of the scale are positive. The rating is in the form of a 4-point Likert and is accepted as never (1), sometimes (2), often (3), and regularly (4). The lowest score for the entire scale is 52 and the highest score is 208. The Cronbach Alpha coefficient of the scale is 0.92; The reliability coefficients of the sub-dimensions are; Health responsibility was found to be 0.77, Physical Activity 0.79, Nutrition 0.68, Spiritual Development 0.79, Interpersonal Relations 0.80, Stress Management 0.64 (Bahar, 2008). **Measure:** Health Lifestyle Behavior Scale **Time Frame:** At the end of week 1 **Description:** Turkish validity Bahar et al. The scale made by has 52 items and six factors. These; spiritual development, interpersonal relationships, nutrition, physical activity, health responsibility and stress management. The overall score of the scale gives the score for healthy lifestyle behaviors. All items of the scale are positive. The rating is in the form of a 4-point Likert and is accepted as never (1), sometimes (2), often (3), and regularly (4). The lowest score for the entire scale is 52 and the highest score is 208. The Cronbach Alpha coefficient of the scale is 0.92; The reliability coefficients of the sub-dimensions are; Health responsibility was found to be 0.77, Physical Activity 0.79, Nutrition 0.68, Spiritual Development 0.79, Interpersonal Relations 0.80, Stress Management 0.64 (Bahar, 2008). **Measure:** Health Lifestyle Behavior Scale **Time Frame:** At the end of week 12 **Description:** The scale, validated in Turkish by Bilgen (2018), consists of four subscales and 30 items. The highest score from the scale can be 150 and the lowest score can be 30. Subdimensions of the scale; It consists of the dimensions of eating in situations of tension (11 items), eating to cope with negative emotions (10 items), self-control (6 items), and control in the face of stimuli (3 items). Cronbach's alpha number of the scale was found to be 0.95 (Bilgen, 2018) **Measure:** Emotional Eating Scale: **Time Frame:** At the end of week 1 **Description:** The scale, validated in Turkish by Bilgen (2018), consists of four subscales and 30 items. The highest score from the scale can be 150 and the lowest score can be 30. Subdimensions of the scale; It consists of the dimensions of eating in situations of tension (11 items), eating to cope with negative emotions (10 items), self-control (6 items), and control in the face of stimuli (3 items). Cronbach's alpha number of the scale was found to be 0.95 (Bilgen, 2018) **Measure:** Emotional Eating Scale: **Time Frame:** At the end of week 12 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Continuing education at all three universities where the research will be conducted * The score obtained from the Post-Earthquake Trauma Level Determination Scale must be higher than the threshold value (52.38±5.05). Exclusion Criteria: • Students who have an existing psychiatric diagnosis and are in their final year will be excluded from the study. **Maximum Age:** 28 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** psoylar@firat.edu.tr **Name:** pınar soylar **Phone:** 05053124192 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M17685 - Name: Wounds and Injuries - Relevance: HIGH - As Found: Trauma ### Condition Browse Module - Meshes - ID: D000014947 - Term: Wounds and Injuries ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06439017 **Brief Title:** Passive Thoughts in Functional Movement Disorders **Official Title:** Passive Thoughts in Functional Movement Disorders #### Organization Study ID Info **ID:** 125294 #### Organization **Class:** OTHER **Full Name:** Western University ### Status Module #### Completion Date **Date:** 2025-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Western University #### Responsible Party **Investigator Affiliation:** Western University **Investigator Full Name:** Aditya Murgai **Investigator Title:** Passive thoughts in functional movement disorders **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Functional movement disorders (FMD) involve unusual movements or walking difficulties that are not caused by a specific brain or nerve injury. Passive thoughts are those that occur spontaneously, and often repetitively. They are different from active thoughts, which are purposeful and intentional, such as those required for tasks like making a cup of coffee or catching a bus. This concept can be paralleled with body movements. Active movements are voluntary and purposeful, while involuntary movements can be seen as passive, arising spontaneously and not under voluntary control. The study aims to explore whether individuals with functional movement disorders experience a higher frequency of passive thoughts compared to normal healthy individuals. A structured questionnaire focused on passive thoughts will be administered to patients with functional movement disorders and to healthy controls. **Detailed Description:** This study aims to measure passive thoughts and their effects in patients with functional movement disorders, using a questionnaire designed to assess passive thoughts. The study will involve completing an online questionnaire, which will take about 5 minutes to complete. The individual responses will remain anonymous. The link will be emailed to the participants and they will be able to complete the questionnaire from their mobile phone, tablet, or computer. The scores from each question and the overall questionnaire score will be compared between FMD patients and healthy controls. ### Conditions Module **Conditions:** - Functional Movement Disorder ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The study will involve completing an online questionnaire, which will take about 5 minutes to complete. The individual responses will remain anonymous. **Intervention Names:** - Other: Questionaire **Label:** Cases with functional movement disorders #### Arm Group 2 **Description:** The study will involve completing an online questionnaire, which will take about 5 minutes to complete. The individual responses will remain anonymous. **Intervention Names:** - Other: Questionaire **Label:** Healthy controls ### Interventions #### Intervention 1 **Arm Group Labels:** - Cases with functional movement disorders - Healthy controls **Description:** The study will involve completing an online questionnaire, which will take about 5 minutes to complete. **Name:** Questionaire **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The Passive Thoughts Questionnaire assesses the severity of passive thoughts and their impact on daily life. **Measure:** Passive thoughts questionnaire **Time Frame:** Day 1 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Diagnosed with a functional movement disorder by the neurologist. 2. Able to understand and read English. Exclusion Criteria: 1. Unable to understand and read English. 2. Diagnosed with dementia **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients diagnosed with functional movement disorder will be included in the study ### Contacts Locations Module #### Locations **Location 1:** **City:** London **Country:** Canada **Facility:** Aditya Murgai **State:** Ontario **Zip:** N6A5A5 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000013001 - Term: Somatoform Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000006677 - Term: Histrionic Personality Disorder - ID: D000010554 - Term: Personality Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12029 - Name: Movement Disorders - Relevance: HIGH - As Found: Movement Disorders - ID: M6515 - Name: Conversion Disorder - Relevance: HIGH - As Found: Functional Movement Disorders - ID: M10096 - Name: Hysteria - Relevance: HIGH - As Found: Functional Movement Disorders - ID: M7394 - Name: Dissociative Disorders - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M15803 - Name: Somatoform 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: M13462 - Name: Personality Disorders - Relevance: LOW - As Found: Unknown - ID: T1568 - Name: Conversion Disorder - Relevance: HIGH - As Found: Functional Movement Disorders ### Condition Browse Module - Meshes - ID: D000009069 - Term: Movement Disorders - ID: D000003291 - Term: Conversion Disorder - ID: D000007046 - Term: Hysteria ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06439004 **Brief Title:** The Use of QST to Characterize Somatosensory Functionality **Official Title:** The Use of Quantitative Sensory Testing to Characterize Somatosensory Functionality #### Organization Study ID Info **ID:** S69194 #### Organization **Class:** OTHER **Full Name:** Universitaire Ziekenhuizen KU Leuven ### Status Module #### Completion Date **Date:** 2024-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universitaire Ziekenhuizen KU Leuven #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Pain has a significant impact on quality of life and poses an enormous burden on the healthcare system. The subjective nature of pain complicates its mapping and treatment. Quantitative Sensory Testing (QST) aims to characterize the somatosensory phenotype using calibrated stimuli and subjective thresholds. This set of procedures enables quantification of the somatosensory function in small fibers (thinly myelinated Aδ and unmyelinated C), as well as large fibers (thickly myelinated Aβ). In this way, sensory loss (hypoesthesia, hypoalgesia) or sensory gain (hyperesthesia, hyperalgesia, allodynia) can be detected. In this study, the inter-period reproducibility of thirteen QST parameters will be determined on the dominant hand, right forearm, right flank and lower back of 20 healthy volunteers. ### Conditions Module **Conditions:** - Pain ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Healthy volunteers to evaluate the inter-period reproducibility of thirteen QST parameters. **Intervention Names:** - Other: Quantitative Sensory Testing **Label:** Healthy volunteers **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Healthy volunteers **Description:** Performing QST on the dominant hand, right forearm, right flank and lower back. **Name:** Quantitative Sensory Testing **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Inter-period reproducibility of thirteen different QST parameters on the dominant hand, right forearm, right flank and lower back of healthy volunteers. **Measure:** Inter-period reproducibility of QST **Time Frame:** Interval of 7 - 21 days between both periods ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Voluntary written informed consent has been obtained prior to any screening procedures. * Subject is ≥ 18 years and ≤ 25 years of age. * Subject is a non-smoker for at least 6 months before the start of the study. * Subject has a body mass index (BMI) between 18-30 kg/m². * Subject is in good general health, based on medical history and vital signs. Exclusion Criteria: * Subject has a history of any illness which, in the investigator's opinion, might confound the results of the study, including conditions which affect the normal somatosensory functionality. * Subject has eczema, scleroderma, psoriasis, dermatitis, or any other abnormality on the skin of the dominant hand, right forearm, right flank or lower back which, in the investigator's opinion, might interfere with the study assessments. * Subject is unable to refrain from drinking alcohol 24 hours prior to each study visit, is currently a user of drugs, or has a history of alcohol and/or drug abuse. * Subject is unable to refrain from drinking caffeinated beverages 24 hours prior to each study visit. * Subject has used concomitant drugs and/or treatments that may interfere, in the investigator's opinion, with the study results. * Subject is in a situation or has a condition which, in the investigator's opinion, may interfere with safe and optimal participation in the study. * Female subject who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and is not using an adequate contraceptive method. * Subject is participating in another trial which, in the investigator's opinion, might confound the results of the study. **Healthy Volunteers:** True **Maximum Age:** 25 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** flore.vanolmen@uzleuven.be **Name:** Flore Van Olmen, MSc **Phone:** + 32 (0)16 34 22 01 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** UZ Leuven **Name:** Jan de Hoon, MD, PhD, MSc **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: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438991 **Brief Title:** Spinal Cord Stimulation for Lower Extremity Function **Official Title:** Epidural Spinal Cord Stimulation for Lower Extremity Motor Function in Spinal Cord Injury #### Organization Study ID Info **ID:** 2024P000184 #### Organization **Class:** OTHER **Full Name:** Brigham and Women's Hospital ### Status Module #### Completion Date **Date:** 2028-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Brigham and Women's Hospital #### Responsible Party **Investigator Affiliation:** Brigham and Women's Hospital **Investigator Full Name:** Yi Lu, MD PhD **Investigator Title:** Director of Neurosurgical Trauma, Associate Professor of Neurosurgery **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This prospective clinical study will investigate the ability of different spine imaging characteristics to predict ambulation recovery responsiveness using epidural spinal cord stimulator (SCS) in patients with chronic incomplete spinal cord injury (SCI). Epidural spinal cord stimulation below the level of injury can restore previously lost lower extremity voluntary motor function for some patients. The goal of this study is to establish whether spine imaging can be utilized as a biomarker to predict which patients will respond to spinal cord stimulation. **Detailed Description:** Ten patients with chronic spinal cord injury who are scheduled to receive a spinal cord stimulator for refractory chronic pain will be recruited throughout the Mass General Brigham health system. At baseline, participants will undergo a neurologic strength exam, Magnetic Resonance Imaging (MRI) of the spine and brain, electromyography (EMG) of the lower extremities, and will complete a battery of pain, motor function and quality of life questionnaires. Phase 1: The SCS Optimization phase consists of weekly research visits during the first month post-SCS implant. Settings of the spinal cord stimulator parameters will be modified for activation and optimal voluntary control of lower extremity muscles. Phase 2: The Individualized Neurorehabilitation phase consists of 4 weekly visits for a 5-month period. Participants will undergo neurorehabilitation with the stimulation settings turned on for motor control. Neurorehabilitation will be individualized and will progressively increase participants' physical activity, including assisted/independent standing, stepping and ambulation within safe limits. Participants will undergo monthly muscle strength and surface EMG testing. At the end of each research visit or neurorehabilitation session, SCS settings will be adjusted to the original pain management parameters. At the 6-month follow up participants will undergo a neurologic strength exam, MRI of the spine and brain, EMG of the lower extremities and a battery of questionnaires. After the last follow up visit, participants will have the opportunity to continue a long-term follow up or exit the study. SCS parameters will be adjusted to the pain management settings. ### Conditions Module **Conditions:** - Spinal Cord Injury **Keywords:** - epidural spinal cord stimulation ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** All subjects will receive a spinal cord stimulator. Muscle strength will be assessed with the stimulation turned on and off. Parameters for motor function will be assessed with the stimulation turned on and off. ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Baseline: participants will undergo lower extremity muscle strength testing, electromyography, spine and brain MRI, and complete a battery of questionnaires All participants will undergo a clinically indicated spinal cord stimulator implanted for refractory chronic pain. SCS Optimization phase consists of weekly research visits for 1 month. SCS parameters will be optimized for voluntary control of lower extremity muscles. Individualized Neurorehabilitation phase consists of 4 x weekly visits for 5-months. With the SCS settings turned on for muscle activation, participants will undergo progressive neurorehabilitation by a spinal cord specialized physical therapist. All participants who complete the 6-month timepoint will be invited to continue long-term follow up. **Intervention Names:** - Other: Adjustment of spinal cord stimulation parameters for voluntary motor control **Label:** All participants **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - All participants **Description:** All patients will receive a spinal cord stimulator and undergo adjustment of stimulation parameters for optimal voluntary lower extremity motor control during research visits. Muscle strength will be assessed with the stimulation turned on and off. **Name:** Adjustment of spinal cord stimulation parameters for voluntary motor control **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The primary endpoint of this study is the safety of stimulation parameters for motor function assessed with the number of adverse events for the duration of the study. Relatedness of adverse events to treatment is determined by the principal investigator. **Measure:** Incidence of treatment-related adverse events **Time Frame:** 0-6 months after baseline #### Secondary Outcomes **Description:** The ability to restore previously lost voluntary motor function of the lower extremity will be measured with the Medical Research Council (MRC) grade and compared to baseline. MRC grades range from 0 (no visible muscle contraction) to 5 (normal muscle strength against full resistance). A higher grade indicates a better outcome. **Measure:** Muscle Strength **Time Frame:** 1-6 months after baseline **Description:** Assessment of the functional integrity of corticospinal tracts with spine and brain Magnetic Resonance Imaging (MRI) will be performed at baseline and at the last follow up. MRI volumetric measures are quantified in mm\^2. **Measure:** Neuroimaging volumetric measures **Time Frame:** 0-6 months after baseline **Description:** Functional change assessed with the total score on the American Spinal Injury Association Impairment Scale (AIS) of each participant before spinal cord stimulation (SCS) and after SCS augmented with neurorehabilitation therapy. The AIS scale ranges from A (no sensory or motor function is preserved in sacral segments of S4-S5) to E (sensation and motor testing are normal in all segments), with A representing the worst outcome and E representing the best outcome. **Measure:** Voluntary Motor Function **Time Frame:** 0-6 months after baseline **Description:** Stimulation amplitude required for voluntary motor function measured in mA (miliAmperes) when supine, assisted/independent standing, stepping, walking. **Measure:** Optimized stimulation amplitude for voluntary motor function **Time Frame:** 1-6 months after baseline **Description:** Stimulation frequency required for voluntary motor function measured in Hz (Hertz) when supine, assisted/independent standing, stepping, walking. **Measure:** Optimized stimulation frequency for voluntary motor function **Time Frame:** 1-6 months after baseline **Description:** Stimulation pulse width required for voluntary motor function measured in microseconds when supine, assisted/independent standing, stepping, walking. **Measure:** Optimized stimulation pulse width for voluntary motor function **Time Frame:** 1-6 months after baseline **Description:** Ability to stand, step, or walk either assisted or unassisted assessed with the Walking Index for Spinal Cord Injury II (WISCI II) scale. The WISCI II scale ranges from minimum score of 0 (unable to stand) to maximum score of 20 (ambulates with no devices, brace or assistance). A higher score represents a better outcome. **Measure:** Locomotive ability **Time Frame:** 1-6 months after baseline **Description:** Serious adverse events related to the post-SCS implant neurorehabilitation therapy. **Measure:** Serious adverse events **Time Frame:** 1-6 months after baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age \>18 years * Provides informed consent * Eligible for and undergoes SCS implant for chronic low back or leg pain refractory to first-line therapy * Stable SCI secondary to a single insult * C6-T10 level of injury * SCI has occurred \>12 months prior to enrollment * Chronic low back pain refractory to first-line therapy * Current AIS grade B-C, with spared sensation * Willingness and ability to adhere to the protocol Exclusion Criteria: * History or diagnosis of Central Nervous System malignancy * Diagnosis that is a contraindication to SCS implantation or surgery * Diagnosis that precludes the subject from full participation in physical therapy * Known osteopenia/osteoporosis * Impairment in post-operative recovery per clinical evaluation by the principal investigator * Inability to participate in the protocol, including but not limited to all study visits and assessments **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jchalif@bwh.harvard.edu **Name:** Joshua I. Chalif, MD, PhD **Phone:** 617-525-7378 **Role:** CONTACT **Contact 2:** **Email:** bjohnston2@mgb.org **Name:** Benjamin R Johnston, MD, PhD **Phone:** 617-525-7378 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Brigham and Women's Hospital/Harvard Medical School **Name:** Yi Lu, MD, PhD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Description:** Individual participant data will not be shared other than published de-identified data. **IPD Sharing:** NO ### References Module #### References **Citation:** Chalif JI, Chavarro VS, Mensah E, Johnston B, Fields DP, Chalif EJ, Chiang M, Sutton O, Yong R, Trumbower R, Lu Y. Epidural Spinal Cord Stimulation for Spinal Cord Injury in Humans: A Systematic Review. J Clin Med. 2024 Feb 14;13(4):1090. doi: 10.3390/jcm13041090. **PMID:** 38398403 **Citation:** Wagner FB, Mignardot JB, Le Goff-Mignardot CG, Demesmaeker R, Komi S, Capogrosso M, Rowald A, Seanez I, Caban M, Pirondini E, Vat M, McCracken LA, Heimgartner R, Fodor I, Watrin A, Seguin P, Paoles E, Van Den Keybus K, Eberle G, Schurch B, Pralong E, Becce F, Prior J, Buse N, Buschman R, Neufeld E, Kuster N, Carda S, von Zitzewitz J, Delattre V, Denison T, Lambert H, Minassian K, Bloch J, Courtine G. Targeted neurotechnology restores walking in humans with spinal cord injury. Nature. 2018 Nov;563(7729):65-71. doi: 10.1038/s41586-018-0649-2. Epub 2018 Oct 31. **PMID:** 30382197 **Citation:** Angeli CA, Edgerton VR, Gerasimenko YP, Harkema SJ. Altering spinal cord excitability enables voluntary movements after chronic complete paralysis in humans. Brain. 2014 May;137(Pt 5):1394-409. doi: 10.1093/brain/awu038. Epub 2014 Apr 8. Erratum In: Brain. 2015 Feb;138(Pt 2):e330. **PMID:** 24713270 **Citation:** Calvert JS, Grahn PJ, Strommen JA, Lavrov IA, Beck LA, Gill ML, Linde MB, Brown DA, Van Straaten MG, Veith DD, Lopez C, Sayenko DG, Gerasimenko YP, Edgerton VR, Zhao KD, Lee KH. Electrophysiological Guidance of Epidural Electrode Array Implantation over the Human Lumbosacral Spinal Cord to Enable Motor Function after Chronic Paralysis. J Neurotrauma. 2019 May 1;36(9):1451-1460. doi: 10.1089/neu.2018.5921. Epub 2018 Dec 15. **PMID:** 30430902 **Citation:** Darrow D, Balser D, Netoff TI, Krassioukov A, Phillips A, Parr A, Samadani U. Epidural Spinal Cord Stimulation Facilitates Immediate Restoration of Dormant Motor and Autonomic Supraspinal Pathways after Chronic Neurologically Complete Spinal Cord Injury. J Neurotrauma. 2019 Aug 1;36(15):2325-2336. doi: 10.1089/neu.2018.6006. Epub 2019 Mar 6. **PMID:** 30667299 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013118 - Term: Spinal Cord Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000020196 - Term: Trauma, Nervous System - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M15916 - Name: Spinal Cord Injuries - Relevance: HIGH - As Found: Spinal Cord Injury - ID: M15915 - Name: Spinal Cord Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M22023 - Name: Trauma, Nervous System - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013119 - Term: Spinal Cord Injuries ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438978 **Acronym:** BBV169/2023 **Brief Title:** Tuberculosis Vaccine in Healthy Indian Adults **Official Title:** An Open-Labelled, Phase I Clinical Trial to Assess the Safety Reactogenicity, Tolerability and Immunogenicity of a Tuberculosis Vaccine BBV169 (MTBVAC), in Healthy Indian Adults #### Organization Study ID Info **ID:** BBIL/MTBVAC/2023 #### Organization **Class:** INDUSTRY **Full Name:** Bharat Biotech International Limited #### Secondary ID Infos **Domain:** Bharat Biotech International Limited **ID:** BBIL/MTBVAC/2023 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2024-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-01-29 **Type:** ACTUAL #### Start Date **Date:** 2024-01-19 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2023-12-11 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Bharat Biotech International Limited #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** An Open-labelled, Phase I Clinical Trial to Assess the Safety, Reactogenicity, Tolerability, and Immunogenicity of MTBVAC in healthy Indian adult volunteers A total of 30 subjects with Quantiferon®-TB Gold Plus assay negative and ages 18 to 65 years will be enrolled in this trial. All the subjects will receive a single dose of MTBVAC via the intradermal route in the right deltoid region. DSMB meetings will be conducted after Day 28 , Day 90 \& Day 180 after vaccinating all subjects. **Detailed Description:** An Open-labelled, Phase I Clinical Trial to Assess the Safety, Reactogenicity, Tolerability, and Immunogenicity of MTBVAC in healthy Indian adult volunteers A total of 30 subjects with Quantiferon®-TB Gold Plus assay negative and ages 18 to 65 years will be enrolled in this trial. All the subjects will receive a single dose of MTBVAC via the intradermal route in the right deltoid region. DSMB meetings will be conducted after Day 28 , Day 90 \& Day 180 after vaccinating all subjects. Study Objectives: Primary Objective To evaluate the safety and reactogenicity of MTBVAC End points: 1. The occurrence of immediate adverse events within 30mins of vaccination \[Time Frame: 30 mins\]. 2. The occurrence of solicited adverse events within fourteen days of vaccination \[Time Frame: daily follow- up for 14 days\]. 3. The injection site reactions will be followed-up for 90 days. 4. The occurrence of any unsolicited adverse events throughout the study duration \[Time Frame: throughout the trial duration\]. 5. The occurrence of serious adverse events (SAEs) \[Time Frame: throughout the trial duration\]. 6. AESI (Adverse Event of Special Interest) is to be considered throughout the trial period. 7. Hematological, biochemical safety test levels before and after vaccination Study design: An Open-labelled, Phase I Clinical Trial to Assess the Safety, Reactogenicity, Tolerability, and Immunogenicity of MTBVAC in healthy Indian adult volunteers A total of 30 subjects with Quantiferon-TB Gold Plus assay negative and ages 18 to 65 years will be enrolled in this trial. All the subjects will receive a single dose of MTBVAC via the intradermal route in the right deltoid region. DSMB meetings will be conducted after Day 28 , Day 90 \& Day 180 after vaccinating all subjects 1. Safety Lab investigations -10ml of blood on Day of screening, Day 28, 90,180. 2. Sputum GeneXpert Ultra Test - Sputum sample at screening for all participants and participants with suspected TB 3. Urine test- CUE for all participants at screening, Day 28,90,180 and UPT (female participant of the child bearing age group) on Day0 ,28,90,180 4. Quantiferon Gold Plus assay -5ml of blood on Day of screening, Day 28,90 ,180. 5. Antigen specific CD4/CD8 response--10ml of blood atDay0, 28,90 180. Study Procedure: Visit1: Screening-7 to 0 1. Screening of healthy adults of age 18-65 years to assess eligibility by inclusion and exclusion criteria for the trial will take place. 2. After obtaining written informed consent from the healthy participants, 3. Demographic information (age, gender, date of birth, weight \[kg\], and height \[cm\], body mass index, address(corresponding and permanent), Contact number, alcohol consumption/substance use, and smoking status/tobacco use),medical history, co-morbid conditions and concomitant medication will be noted, 4. A physical examination of the subject will be carried out. ECG, Chest X-ray, USG abdomen, and sputum for AFB \& GeneXpert ultra test will be done for all subjects. 5. 10ml of the blood sample will be collected for screening lab investigations which include CBP, liver function tests, kidney function tests, lipid profile, ESR, RBS, CRP, CUE, TSH, beta HCG (female subjects of, child bearing age group), and serology for HIV1 and 2, HbsAg and HCV. 6. 5ml of the blood sample will be collected for Quantiferon Gold Plus assay. 7. QFT Plus negative subjects will be recruited. Visit 2:Baseline Day 0 1. From the eligible subjects (in good general health or stable preexisting disease as per the discretion of the principal investigator), blood samples will be withdrawn for Immunogenicity analysis, and urine for UPT \[for females of child bearing potential\] will be done before vaccination. 2. After administration of the trial vaccine, the subjects will remain at the trial site for at least 30 minutes of observation to record any immediate adverse event. 3. An injection site Photograph will be captured after the assessment of injection site reactions. 4. Diary cards will be distributed to the subjects. 5. Telephonic follow-up is done for 6 days to assess the solicited events and health status. Visit3: Day7+1 1. The subjects will visit the trial site 7 days after vaccination for safety assessment, which includes solicited and unsolicited adverse events, medical history, vital signs, physical examination, and concomitant medications. The participant will be interviewed for any suspected TB symptoms and concomitant medication. During this visit, the trial personnel will review and collect the diary card. 2. New Diary card will be distributed. 3. An injection site photograph will be captured after the assessment of injection site reactions. 4. Telephonic follow-up will be done for next 7 days to assess the solicited events and health status Visit4: Day 28±2 1. The subjects will visit the trial site 28±2 days after vaccination. During this visit, the subjects will be examined physically and the history of any adverse events, suspected TB symptoms, and concomitant medications will be asked. The trial personnel will review and collect the diary card. Blood samples will be withdrawn to assess Immunogenicity and safety lab investigations-CBP, Liver function tests, Kidney function tests, Lipid Profile, ESR, CRP and RBS. 2. An injection site photograph will be captured after assessment of injection site reactions 3. Urine samples will be collected for complete urine examination for all and UPT \[wherever required\] Visit5: Day 90+7 1. The subjects will visit the trial site 90+7 days after vaccination. During these visits, the subjects will be physically examined and a history of any adverse events, suspected TB symptoms and concomitant medications will be asked. Injection site Photograph will be captured after assessment of injection site reactions. Blood samples will be withdrawn to assess Immunogenicity and safety lab investigations- CBP, Liver function tests, Kidney function tests, Lipid Profile, ESR, CRP and RBS. 2. Urine samples will be collected for complete urine examination for all and UPT \[wherever required\] Visit6:Day180+7 1. The subjects will visit the trial site 6 months after vaccination. During this visit, the subjects will be physically examined and the history of any adverse events suspected TB symptoms, and concomitant medications will be asked. Injection site Photograph will be captured after assessment of injection site reactions. Blood samples will be withdrawn to assess Immunogenicity and safety lab investigations-CBP, Liver function tests, Kidney function tests, Lipid Profile, ESR, CRP and RBS 2. Urine samples will be collected for complete urine examination for all and UPT \[wherever required\] Visit for Clinically suspected TB during follow-up: 1. If any participant develops TB symptoms (including but not limited to persistent cough, hemoptysis, fever, unintended weight loss, fatigue or lethargy, night sweats, or pleuritic chest pain) during the follow-up after vaccination, he/she will be advised to report to the trial clinic. 2. A detailed medical history with a thorough physical examination will be done. Based on the results subjects will be classified as follows: 1. In suspected PTB, the trial investigator will undertake investigations (bacteriological, microbiological, and radiological) as per National Tuberculosis Elimination Program (NTEP) guidelines for confirming PTB. If confirmed, the trial investigator will provide/refer participant to concerned department for the required treatment as per NTEP guidelines and will ensure safety follow-up till the end of the trial. 2. In suspected EPTB, the trial investigator will undertake the required investigations for confirming the diagnosis of EPTB as per NTEP guidelines. If confirmed, the trial investigator will provide/refer participant to concerned department for the required treatment as per NTEP guidelines and will ensure safety followup till the end of the trial. 3. If any subject is confirmed with any form of TB, they will not be assessed for Immunogenicity further, But safety will be followed up to 180days 4. If the participant is not diagnosed with TB (PTB or EPTB) as per NTEP guidelines, he/she will be continued in to the trial and followed up till the end of the trial period. 5. All the TB cases will be reviewed by the Adjudication committee ### Conditions Module **Conditions:** - Tuberculosis ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 30 healthy, BCG vaccinated, HIV negative, adults, aged 18 - 65 years, in whom LTB Infection has been excluded by negative QuantiFERON® (QFT) Gold-Plus assay. **Intervention Names:** - Biological: Tuberculosis Vaccine **Label:** MTBVAC **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - MTBVAC **Description:** 1. Live, attenuated Mycobacterium tuberculosis (M. tb)- MTBVAC (MTBVAC)01 strain 2. 3-17x105CFU (Per dose) Sucrose Sodium glutamate 3. Lyophilized pellet in vials (10doses) 4. 0.1 mL/dose (After reconstitution with 1 mL/vial sterilized water for injection) **Name:** Tuberculosis Vaccine **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Adverse reactions after administration of each dose **Measure:** To evaluate the safety and reactogenicity of MTBVAC Immediate reaction **Time Frame:** 30 Minutes of vaccination. **Description:** Incidence, intensity, and the causality of all solicited adverse events during the 14-day follow up period after each dose. **Measure:** To evaluate the safety and reactogenicity of MTBVAC-Solicited adverse events **Time Frame:** 14 days **Description:** The injection site reactions will be followed-up for 90days. **Measure:** To evaluate the safety and reactogenicity of MTBVAC-injection site reactions **Time Frame:** 90 Days **Description:** The occurrence of any unsolicited adverse events throughout the study duration **Measure:** To evaluate the safety and reactogenicity of MTBVAC-unsolicited adverse events **Time Frame:** Through out the trial duration till Day180 Days **Description:** Incidence, intensity, and the causality of all adverse events and Serious Adverse Events (SAEs) during the entire study period. **Measure:** To evaluate the safety and reactogenicity of MTBVAC-Serious Adverse Events (SAEs) **Time Frame:** Through out the trial duration till Day180 Days **Description:** AESI (Adverse Event of Special Interest) is to be considered throughout the trial period. **Measure:** To evaluate the safety and reactogenicity of MTBVAC-AESI (Adverse Event of Special Interest) **Time Frame:** Through out the trial period till Day180 Days **Description:** Hematological safety test levels before and after vaccination **Measure:** To evaluate the safety and reactogenicity of MTBVAC-Hematological safety test levels before and after vaccination **Time Frame:** before and after vaccination on Day 0 **Description:** Biochemical safety test levels before and after vaccination **Measure:** To evaluate the safety and reactogenicity of MTBVAC-Biochemical safety test levels before and after vaccination **Time Frame:** before and after vaccination on Day 0 #### Secondary Outcomes **Description:** Cellular immune responses \[QFT Plus \] at Days 28 **Measure:** Cellular immune responses **Time Frame:** Days 28 **Description:** Cellular immune responses \[QFT Plus \] at Days 90 **Measure:** Cellular immune responses **Time Frame:** Days 90 **Description:** Cellular immune responses \[QFT Plus \] at Days 180. **Measure:** Cellular immune responses **Time Frame:** Days 180 **Description:** Antigen-specificCD4/CD8responseatDays0, 28, 90 and 180 **Measure:** Antigen-specificCD4/CD8 response **Time Frame:** Days 0,28,90 and 180 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Ability to provide written informed consent.\[Audio video consent for vulnerable subjects\] 2. Participants of either gender of age between ≥18 to ≤65years. 3. Only QFT negative participants will be included 4. Good general health as determined by the discretion of the investigator (vital signs (heart rate ≥60 to≤100 bpm; blood pressure systolic ≥90 mm Hg and \<140 mm Hg; diastolic ≥ 60 mm Hg and \<90 mm Hg; oral temperature \<100.4ºF), medical history, and physical examination). 5. Expressed interest and availability to fulfill the study requirements. 6. For a female participant of childbearing potential, planning to avoid pregnancy (use of an effective method of contraception or abstinence) from the time of study enrolment until at least 3 months after IP administration. 7. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from IP administration until 3 months. 8. No evidence of active TB disease during screening - Normal chest radiograph and no bacteriological positivity by Genexpert plus test of sputum for M. tb 9. Clinically acceptable laboratory values for blood tests and a negative pregnancy test (for childbearing-age women) 10. Seronegative for human immunodeficiency virus 1 and -2 (HIV- 1/2) antibodies, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibodies. 11. Had BCG vaccination at Birth, documented through medical history or presence of scar. - Exclusion Criteria: 1. Any chronic febrile illness with oral temperature \> 100°F on the day of enrollment. 2. Evidence of pulmonary pathology as confirmed by chest X-ray. 3. History of any form of TB Disease. 4. Prior or present anti-TB treatment 5. Received Tuberculin Skin Test (TST) within 3 months (90 days) prior to Study Day 0. 6. Clinical evidence of Active TB 7. Subjects with house hold contacts of Active TB 8. History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations (any vaccine). 9. QFT Plus positive subjects. 10. History of allergic disease or reactions. 11. History of previous administration of experimental Mycobacterium tuberculosis vaccines. 12. Use of any investigational or non-registered product (drug or vaccine) in another experimental protocol other than the trial vaccines within 30 days preceding the vaccination, or planned use during the trial period. 13. Any chronic drug therapy to be continued during the trial period. 14. Chronic administration of immune suppressors or other immune- modifying drugs. 15. Administration of any immunoglobulins, any immunotherapy, and/or any blood products within the three months preceding the vaccination, or planned administrations during the trial period. 16. Any confirmed or suspected immunosuppressive or immunodeficient condition (including HIV) based on medical history and physical examination. 17. Any condition or history of any acute or chronic illness or medication, which, in the opinion of the Investigator, may interfere with the evaluation of the trial objectives. 18. A family history of congenital or hereditary immunodeficiency. 19. History of any neurologic disorders or seizures. 20. History of chronic alcohol consumption and/or drug abuse. 21. Major congenital defects. 22. Pregnant or lactating female. 23. Female planning to become pregnant or planning to discontinue contraceptive precautions until 3 months. 24. Those who have been vaccinated with live attenuated vaccines within 30 days of trial vaccine administration and those who are planning to take live attenuated vaccine within 30 days after trial vaccine administration 25 . Administration of any vaccines that are not live attenuated 30 Days before trial vaccine administration - **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Hyderabad **Country:** India **Facility:** NIMS, Hyderabad **State:** Telangana **Zip:** 500082 #### Overall Officials **Official 1:** **Affiliation:** Bharat Biotech International Limited **Name:** Dr.V.Krishna Mohan, PhD **Role:** STUDY_DIRECTOR ### 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 ### 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: M17127 - Name: Tuberculosis - Relevance: HIGH - As Found: Tuberculosis - 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 ### Condition Browse Module - Meshes - ID: D000014376 - Term: Tuberculosis ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M4793 - Name: BCG Vaccine - Relevance: LOW - As Found: Unknown - ID: M17360 - Name: Vaccines - Relevance: LOW - As Found: Unknown - ID: T5 - Name: Glutamic Acid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438965 **Brief Title:** MSOT as Non-invasive Biomarker for Diagnosis and Monitoring of Neuromuscular Diseases **Official Title:** Multispectral Optoacoustic Imaging (MSOT) as Non-invasive Biomarker for Diagnosis and Monitoring of Neuromuscular Diseases (MSOT-NMD) #### Organization Study ID Info **ID:** MSOT-01 #### Organization **Class:** OTHER **Full Name:** Children's Hospital of Eastern Ontario ### Status Module #### Completion Date **Date:** 2028-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Children's Hospital of Eastern Ontario #### Responsible Party **Investigator Affiliation:** Children's Hospital of Eastern Ontario **Investigator Full Name:** Hanns Lochmuller **Investigator Title:** Professor of Neurology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this study is to learn if Multispectral Optoacoustic Tomographs (MSOT) works to diagnose and follow the course of neuromuscular diseases (NMDs) in children. MSOT scans will be obtained from muscle region to measure hemo/myoglobin, collagen and lipid content/signal and oxygenation in patients with neuromuscular diseases. No additional research activities -other than MSOT - will be done during this study. Existing clinical, laboratory and imaging data from standard-of-care procedures will be correlated with the MSOT data. The expected total duration of the study is approximately 36 months. Repeated measurements will be done to evaluate disease progression and the value of MSOT in NMD. ### Conditions Module **Conditions:** - Neuromuscular Diseases ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 240 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Muscle regions of the patients with neuromuscular diseases will be imaged using the MSOT device. Repeated measurements will be done after 6-12 months. **Intervention Names:** - Device: Multispectral Optoacoustic Tomography (MSOT) **Label:** Patient with neuromuscular disease ### Interventions #### Intervention 1 **Arm Group Labels:** - Patient with neuromuscular disease **Description:** MSOT scans will be obtained from two muscle region to measure hemo/myoglobin, collagen and lipid content/signal and oxygenation in patient with neuromuscular diseases. **Name:** Multispectral Optoacoustic Tomography (MSOT) **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Comparison of the quantitative proportion of collagen, lipid, and hemo/myoglobin signal determined by MSOT in muscle tissue of patients with different neuromuscular diseases with their clinical data. **Measure:** Comparison of the quantitative proportion of collagen, lipid, and hemo/myoglobin signal **Time Frame:** Every 6-12 month, assessed up to 36 months. Some people might be in the study for a very short time, some might be in it for 36 months depending on the time they join the study #### Secondary Outcomes **Description:** Comparison of the quantitative amount of lipid and collagen signal determined by MSOT in muscle tissue of children with different neuromuscular diseases. **Measure:** Comparison of the quantitative amount of lipid and collagen signal **Time Frame:** Every 6-12 month, assessed up to 36 months. Some people might be in the study for a very short time, some might be in it for 36 months depending on the time they join the study **Description:** Comparison of the quantitative proportion of oxygenated/deoxygenated hemo/myoglobin signal in muscle tissue of children with different neuromuscular diseases. **Measure:** Comparison of the quantitative proportion of oxygenated/deoxygenated hemo/myoglobin signal **Time Frame:** Every 6-12 month, assessed up to 36 months. Some people might be in the study for a very short time, some might be in it for 36 months depending on the time they join the study **Description:** Comparison of the quantitative amount of oxygenated/deoxygenated hemo/myoglobin signal determined by MSOT in muscle tissue of children with different neuromuscular diseases **Measure:** Comparison of the quantitative amount of oxygenated/deoxygenated hemo/myoglobin signal **Time Frame:** Every 6-12 month, assessed up to 36 months. Some people might be in the study for a very short time, some might be in it for 36 months depending on the time they join the study **Description:** Comparison of the MSOT-determined quantitative amount of hemo/myoglobin, lipid, and collagen signal at different positions /muscle groups intraindividually in children with different neuromuscular diseases, to identify disease specific distribution patterns **Measure:** Comparison of the MSOT-determined quantitative amount of hemo/myoglobin, lipid, and collagen signal at different positions /muscle groups intraindividually **Time Frame:** Every 6-12 month, assessed up to 36 months. Some people might be in the study for a very short time, some might be in it for 36 months depending on the time they join the study **Description:** Comparison of the quantitative proportion of oxygenated/deoxygenated hemo/myoglobin, lipid, and collagen signal determined by MSOT at different positions /muscle groups intraindividually in children with different neuromuscular diseases, to identify disease specific distribution patterns **Measure:** Comparison of the quantitative proportion of oxygenated/deoxygenated hemo/myoglobin, lipid, and collagen signal determined by MSOT at different positions /muscle groups intraindividually **Time Frame:** Every 6-12 month, assessed up to 36 months. Some people might be in the study for a very short time, some might be in it for 36 months depending on the time they join the study **Description:** Correlation of the collagen signal determined with MSOT with clinical assessments performed on a routine level during visits. **Measure:** Correlation of the collagen signal **Time Frame:** Every 6-12 month, assessed up to 36 months. Some people might be in the study for a very short time, some might be in it for 36 months depending on the time they join the study **Description:** Correlation of the oxygenated/deoxygenated hemo/myoglobin signal determined with MSOT clinical assessments performed on a routine level during visits. **Measure:** Correlation of the oxygenated/deoxygenated hemo/myoglobin signal determined with MSOT clinical assessments **Time Frame:** Every 6-12 month, assessed up to 36 months. Some people might be in the study for a very short time, some might be in it for 36 months depending on the time they join the study **Description:** Correlation of the collagen signal determined with MSOT with routine laboratory tests such as blood creatine kinase (CK) levels, transaminases. **Measure:** Correlation of the collagen signal determined with MSOT with routine laboratory tests **Time Frame:** Every 6-12 month, assessed up to 36 months. Some people might be in the study for a very short time, some might be in it for 36 months depending on the time they join the study **Description:** Correlation of the oxygenated/deoxygenated hemo/myoglobin signal determined by MSOT with routine laboratory tests such as blood CK levels, transaminases. **Measure:** Correlation of the oxygenated/deoxygenated hemo/myoglobin signal determined by MSOT with routine laboratory tests **Time Frame:** Every 6-12 month, assessed up to 36 months. Some people might be in the study for a very short time, some might be in it for 36 months depending on the time they join the study **Description:** Correlation of the collagen signal determined with MSOT with patient reported outcome measures. **Measure:** Correlation of the collagen signal determined with MSOT with patient reported outcome measures. **Time Frame:** Every 6-12 month, assessed up to 36 months. Some people might be in the study for a very short time, some might be in it for 36 months depending on the time they join the study **Description:** Correlation of the oxygenated/deoxygenated hemo/myoglobin signal determined by MSOT with patient reported outcome measures. **Measure:** Correlation of the oxygenated/deoxygenated hemo/myoglobin signal determined by MSOT with patient reported outcome measures. **Time Frame:** Every 6-12 month, assessed up to 36 months. Some people might be in the study for a very short time, some might be in it for 36 months depending on the time they join the study **Description:** Correlation of the collagen signal determined with MSOT with the current treatment regimen in patients with NMD. **Measure:** Correlation of the collagen signal determined with MSOT with the current treatment regimen **Time Frame:** Every 6-12 month, assessed up to 36 months. Some people might be in the study for a very short time, some might be in it for 36 months depending on the time they join the study **Description:** Correlation of the oxygenated/deoxygenated hemo/myoglobin signal determined by MSOT with the current treatment regimen in patients with NMD. **Measure:** Correlation of the oxygenated/deoxygenated hemo/myoglobin signal determined by MSOT with the current treatment regimen **Time Frame:** Every 6-12 month, assessed up to 36 months. Some people might be in the study for a very short time, some might be in it for 36 months depending on the time they join the study ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Patients with neuromuscular disease * Children (from birth (infants that are born term) to 18 years of age) participants or consent through authorized guardian * Confirmed or suspected diagnosis of a neuromuscular disease (through molecular genetics, biopsy, clinical examination) Exclusion Criteria: Participants: * Diagnosis is not consistent with a confirmed or suspected neuromuscular disease * Patients with active skin lesions (e.g. infections, trauma) or confirmed genetic disorders (e.g. epidermolysis bullosa) that predisposes to skin lesion * Medically unstable patients * Tattoo on skin overlying the area to be examined * Missing consent form * Exclusion due to safety concerns of the investigator (subject who has any condition, including any physical, psychological, or psychiatric condition, which in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data and renders the subject an unsuitable candidate for the study) * Medication leading to increased light sensitivity **Maximum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT **Study Population:** Children with various neuromuscular diseases who are seen at the Children's Hospital of Eastern Ontario will be offered to participate in the study as part of their diagnostic work-up and at regular intervals during their ongoing care. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** hlochmuller@toh.ca **Name:** Hanns Lochmuller, Dr. **Phone:** (613) 737-7600 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12411 - Name: Neuromuscular Diseases - Relevance: HIGH - As Found: Neuromuscular Diseases ### Condition Browse Module - Meshes - ID: D000009468 - Term: Neuromuscular Diseases ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438952 **Brief Title:** Efficacy and Duration of Pain Relief in Transforaminal and Lumbar Sympathetic Blocks **Official Title:** Efficacy and Duration of Pain Relief in Transforaminal and Lumbar Sympathetic Blocks #### Organization Study ID Info **ID:** E.142568 #### Organization **Class:** OTHER **Full Name:** Bezmialem Vakif University ### Status Module #### Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Bezmialem Vakif 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:** Low back pain is a symptom that is frequently seen in the general population and reduces the quality of life of patients. Conventional medical treatment for patients with low back pain includes oral medication, lifestyle modification, education, exercises, lumbar traction and manual manipulation, heat application, and other interventional procedures. Epidural injections, one of the interventional procedures, are one of the common treatment methods for low back pain, especially caused by disc prolapse. Steroids are commonly used to reduce inflammation in the epidural space. Epidural steroid injection can be given to the lumbar epidural space via transforaminal, interlaminar and caudal routes, and the effectiveness rate of each is different. These interventional methods used to treat low back pain can be applied in combination. The main purpose of this study is to observe how adding lumbar sympathetic blockade will affect the patient's pain in the postoperative period in patients to whom we applied caudal epidural and transforaminal steroid injection. **Detailed Description:** Low back pain is a symptom that is frequently seen in the general population and reduces the quality of life of patients. Conventional medical treatment for patients with low back pain includes oral medication, lifestyle modification, education, exercises, lumbar traction and manual manipulation, heat application, and other interventional procedures \[1, 2\]. Epidural injections, one of the interventional procedures, are one of the common treatment methods for low back pain, especially caused by disc prolapse. Steroids are widely used to reduce inflammation in the epidural space \[3, 4\]. Epidural steroid injection can be administered to the lumbar epidural space via transforaminal, interlaminar and caudal routes, and each has different efficacy rates \[5-7\]. Sympathetically maintained pain, including lumbar sympathetic ganglion block (LSGB), complex regional pain syndrome (CRPS) types I and II, neuropathies (such as postherpetic neuralgia, stump or phantom limb pain), diabetic polyneuropathy, and ischemic pain from vascular insufficiency in the lower leg It is a widely applied procedure for diagnosing and managing diseases \[8\]. The autonomic nervous system consists of sympathetic and parasympathetic departments. As the name suggests, blood supply to the lower extremity increases after lumbar sympathetic block. This is useful in sympathetic system-mediated treatment of pain \[9\]. The most important reason for adding fentanyl and magnesium as adjvams is to improve the quality of analgesia and provide analgesia for a longer period of time. Both fentanyl and magnesium have the ability to modulate neurotransmitter release and affect neuronal excitability. Fentanyl demonstrates the role of the sympathetic nervous system in modulating pain by increasing the effectiveness of endogenous opioids in the sympathetic ganglia and central nervous system. Magnesium competes with calcium; It reduces the release of neurotransmitters such as acetylcholine. Magnesium's ability to inhibit the release of acetylcholine contributes to its anticonvulsant properties. Additionally, blocking NMDA receptors contributes to its analgesic effects. Additionally, magnesium's ability to enhance the effects of local anesthetics has been studied. By increasing the firing threshold in nerves and causing hyperpolarization, magnesium enhances the effect of local anesthetics, thereby improving nerve blockade. This enhancement of nerve blockade is particularly evident when magnesium is added to agents such as bupivacaine \[10, 11\]. These interventional methods used to treat low back pain can be applied in combination. There is not enough research on this subject. ### Conditions Module **Conditions:** - Low Back Pain - Lumbar Disc Herniation **Keywords:** - Transforaminal Steroid İnjection - Lumbar Sympathetic Blockade - Lumbar Disc Herniation - Neuropathic Pain Questionnaire - Numerical Rating Scale ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The patient will receive both transforaminal steroid injection and lumbar sympathetic blockade. **Intervention Names:** - Procedure: Transforaminal steroid injection combined with lumbar sympathetic blockade **Label:** Addition of lumbar sympathetic blockade to transforaminal steroid injection **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** The patient will only receive transforaminal steroid injection. **Intervention Names:** - Procedure: Transforaminal steroid injection only **Label:** Transforaminal steroid injection only **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Addition of lumbar sympathetic blockade to transforaminal steroid injection **Description:** Transforaminal steroid injection will be made with 2 mg dexamethason + 20 mg lidocaine + 5mg bupivacaine + 5 mcg fentanyl + 100mg magnesium under US-guidance Lumbar sympathetic blockade will be made with 5 ml 0.5% bupivacaine + 6 mg dexamethason + 10 ml NaCl **Name:** Transforaminal steroid injection combined with lumbar sympathetic blockade **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Transforaminal steroid injection only **Description:** Transforaminal steroid injection will be made with 2 mg dexamethason + 20 mg lidocaine + 5mg bupivacaine + 5 mcg fentanyl + 100mg magnesium under US-guidance **Name:** Transforaminal steroid injection only **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Postoperative pain assessed with numeric rating scale (NRS 0: no pain 10:pain as bad as can be ) **Measure:** Pain intensity score **Time Frame:** Preoperative and postoperative 24th hour, 1st week, 1st month and 6th month #### Secondary Outcomes **Measure:** Oswestry Disability Index (ODI) **Time Frame:** Preoperative and postoperative 24th hour, 1st week, 1st month and 6th month **Measure:** Neuropathic pain questionnaire **Time Frame:** Preoperative and postoperative 24th hour, 1st week, 1st month and 6th month **Description:** The patient is asked to give a score between 1 and 10 in terms of satisfaction with the procedure (1 = I am not satisfied with the procedure, 10 = I am very satisfied with the procedure). **Measure:** Patient satisfaction **Time Frame:** Patient satisfaction measured using a numeric rating scale 0 to 10 (0 = unsatisfied; 10 =very satisfied) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ASA I-II-III * Patients who underwent facet joint injection and transforaminal injection due to lumbar disc herniation Exclusion Criteria: * Patients with known allergies to the drugs to be used in treatment * Infection near the puncture site * Known coagulation disorders * Patients with internal fixation or severe anatomical variation such as scoliosis and tumor * History of sympathetic chemical or thermal neurolysis * Alcohol and drug use * Disorder of consciousness * Liver failure, renal failure, advanced cardiac failure * Uncontrolled diabetes mellitus * Morbid obesity (body mass index (BMI) \> 35 kg m-2) * Female patients during pregnancy and breastfeeding * Not approving the informed consent form **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** etikkurul@bezmialem.edu.tr **Name:** Zübeyde Özdemir **Phone:** +90 2125232288 **Phone Ext:** 3238 **Role:** CONTACT #### Locations **Location 1:** **City:** Istanbul **Contacts:** ***Contact 1:*** - **Email:** aylincerensanli@hotmail.com - **Name:** Aylin C Sanli, Asist Dr - **Phone:** +0905496522412 - **Role:** CONTACT **Country:** Turkey **Facility:** Aylin Ceren Şanlı **Status:** RECRUITING **Location 2:** **City:** Istanbul **Country:** Turkey **Facility:** Aylin Ceren **Status:** COMPLETED #### Overall Officials **Official 1:** **Affiliation:** ethics committee chairman **Name:** Zübeyde Özdemir **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Description:** yes **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001416 - Term: Back Pain - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000013122 - Term: Spinal Diseases - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal 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: BC05 - Name: Musculoskeletal Diseases ### Condition Browse Module - Browse Leaves - ID: M4714 - Name: Back Pain - Relevance: LOW - As Found: Unknown - ID: M19433 - Name: Low Back Pain - Relevance: HIGH - As Found: Low Back Pain - ID: M12381 - Name: Neuralgia - Relevance: LOW - As Found: Unknown - ID: M9625 - Name: Hernia - Relevance: HIGH - As Found: Herniation - ID: M10439 - Name: Intervertebral Disc Displacement - Relevance: HIGH - As Found: Disc Herniation - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: 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: D000007405 - Term: Intervertebral Disc Displacement - ID: D000017116 - Term: Low Back Pain - ID: D000006547 - Term: Hernia ### Intervention Browse Module - Browse Branches - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: ChanBlk - Name: Channel Blockers - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AdjAn - Name: Adjuvants, Anesthesia - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M11014 - Name: Lidocaine - Relevance: LOW - As Found: Unknown - ID: M5315 - Name: Bupivacaine - Relevance: LOW - As Found: Unknown - ID: M8418 - Name: Fentanyl - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438939 **Acronym:** NBI_Oral **Brief Title:** NBI for Early Diagnosis of OPMD/OSCC **Official Title:** Narrow Band Imaging (NBI) for Early Diagnosis of Oral Squamous Cell Carcinoma (OSCC) and Oral Potentially Malignant Disorders (OPMD) #### Organization Study ID Info **ID:** 06/24 #### Organization **Class:** OTHER **Full Name:** Cardarelli Hospital ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-08-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cardarelli Hospital #### Responsible Party **Investigator Affiliation:** Cardarelli Hospital **Investigator Full Name:** Agostino Guida **Investigator Title:** Consultant **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Early detection - possibly at its pre-malignant stages (Oral Potentially Malignant Disorders, OPMD) - with periodic surveillance is thus fundamental for limiting disease burden, hopefully reducing the incidence of advanced stages OSCC and increasing survival. Narrow Band Imaging (NBI) has proved itself as promising tool for helping clinician both for diagnosis and therapy. Yet, there is no definitive scientific evidence that NBI is superior to common oral examination with white light (WLOE) for diagnosing OSCC/OPMD. We thus propose a randomised clinical trial understand its role in this field. **Detailed Description:** Introduction Oral squamous cell carcinoma (OSCC) is a malignant condition arising from the mucosal lining of the mouth. It is the most frequent malignancy that affects the oral cavity, with more than 350,000 new incident cases estimated worldwide yearly, causing over 150,000 deaths in 2020. The 5-year overall survival rate of OSCC - around 60%- has not significantly improved during the last decades, despite general clinical and therapeutic advances. Considering that patients with initial stages (I-II) of OSCC show survival rates of 80-90%, while advanced-stages (III-IV) survival stands lower than 50%, it is apparent that the overall survival low value reflects that most cases are diagnosed at advanced stages. Early detection - possibly at its pre-malignant stages (Oral Potentially Malignant Disorders, OPMD) - with periodic surveillance is thus fundamental for limiting disease burden, hopefully reducing the incidence of advanced stages OSCC and increasing survival. Narrow Band Imaging (NBI) is a non-invasive imaging fiberoptic technique which allows the analysis of the thin sub-epithelial vascularisation through visual magnification. There is high scientific evidence that NBI fibroscopy facilitate early diagnosis of squamous cancers of the upper aerodigestive tract. In the oral cavity, it has proved itself as promising tool for helping clinician both for diagnosis and therapy. Yet, there is no definitive scientific evidence that NBI is superior to common oral examination with white light (WLOE) for diagnosing OSCC/OPMD. Materials \& Methods The primary outcome of this study is a comparison of the detection rates of OSCC or an OPMD using oral examination with white light (WLOE) and Narrow Band Imaging (NBI). The secondary outcome is to estimate the overall diagnostic accuracy (sensitivity, specificity, NPV, PPV) of the two methods, according to the presenting condition: * patients with any oral mucosal lesions necessitating an initial diagnosis; * patients with known OPMDs or had their OPMDs excised. * patients with history of Head \& Neck (HN)SCC * high risk patients (heavy smokers, drinkers, individuals with Fanconi anaemia, dyskeratosis congenita, xeroderma pigmentosum, Li-Fraumeni syndrome, Bloom syndrome, ataxia-telangiectasia, and Cowden syndrome) with no oral lesion/disease at the time of examination. To evaluate diagnostic accuracy, we propose to use the histologic diagnosis from a biopsy specimen as the gold standard diagnosis. Study Design This clinical trial, once approved by Ethical Committee, will be registered on ClinicalTrial.gov online platform. Patients will be randomly assigned to receive primary WLOE or primary NBI. To improve the quality of the reporting in the diagnostic accuracy study, we complied with the Standards for Reporting of Diagnostic Accuracy (STARD) initiative. We set WLOE as reference standard and NBI as index test. Random assignment will be performed for each case by an investigator using National Insitute of Health (NIH) - National Cancer Institute Clinical Trial Randomization Tool (https://ctrandomization.cancer.gov/tool). This Web site is available only to the study participants. Using a minimization algorithm, the selection of the primary examination is balanced with respect to five stratification variables: institution, age, sex, alcohol consumption, and smoking habit. In order to give patients the highest possible standard of care, we will perform both imaging methods in a back-to-back fashion so that primary WLOE is followed by NBI and primary NBI is followed by WLOE. To avoid any bias, the report of the first examination is completed before the second imaging is started. Study population and study design are summarised in the flowchart. Study Populations The protocol and consent form for this study has been approved by the Ethical committee of the A.O.R.N. "ANTONIO CARDARELLI" Hospital (n°06/24), Naples, Italy; written informed consent is obtained from all patients. The inclusion criteria are: * Patients with soft tissue, mucosal lesions of the oral cavity, who arrive for an initial first diagnosis (group 1); * Patients with history OPMD (clinically evident lesion/s group 2a, lesion/s excised group 2b), who are in follow-up (OPMDs included are eg. Leukoplakia, erythroleukoplakia, erythroplakia, oral lichen planus, oral lichenoid lesion); * Patients with history of HNSCC (OSCC group 3a, sinonasal, nasopharynx, oropharynx, larynx, oesophagus group 3b); * High risk (see above) individuals with no known oral mucosal disease (group 4); Exclusion criteria will be: * patients who did not need a biopsy nor after WLOE (e.g. normal mucosa, anatomical variation) nor after NBI (pattern I) * patients who, despite indication, were not suitable to undergo biopsy given his / her systemic conditions The pathologists will be blinded to the endoscopic information. In case biopsy showed OSCC, patients would be directed for subsequent diagnostic/therapeutic pathway. OPMD cases will be managed in the unit under routine care. Calculation of the Sample Size For the purposes of this study, we set the probability for error (alfa) to .05 with a power of 0.80 (reflecting a beta error of .2). We estimated that the NBI system would increase the detection yield for superficial cancer by at least threefold compared with conventional WLOE. This resulted in a calculated sample size of 125 patients per category WLOE/NBI, rounded up in 60 (30 WLOE + 30 NBI) patients per group 1/2/3/4. Endoscopic Examination All NBI observations will include the whole oral cavity including mucosal aspect of lips. NBI system consist in a flexible fiberscope, producing magnified images to a fullHD monitor. Angle of the fiberscope, emitting light (WL, NBI) and recording is controlled throug a joystick at fiberscope's grip. NBI imaging for Intrapapillary capillary loops (IPCL) patterns of each lesion will be determined according to modifications made by Farah of the system proposed by Takano, as it proved to be the most effective system for oral lesions: * type 0 (IPCL not detectable) * type I (physiological arborisation of IPCL) * type II (meandering or dilated IPCL) * type III (convoluted/winding and/or elongated IPCL) * type IV (complete loss of organisation/annihilation of IPCL). The biopsy sample will be taken from the area of highest NBI pattern detected during NBI examination. To maintain the quality of the NBI inspection and to reduce risk of operator-dependent bias, before the study is started, all the participating operators will be trained by an expert. Each NBI fibroscopy is recorded and reviewed by an expert (AG), blinded to the result of an eventual biopsy and to the other evaluation result. Expert review is then sent back to the initial operator. Differences in determination of IPCL pattern will be resolved through discussion, obtaining a consensus pattern. In case the consensus pattern showed necessity for biopsy (pattern III, IV), if not already performed, the patient is re-called to undergo biopsy. Pathologic Evaluation Biopsy specimens are taken from each lesion after the completion of both types of imaging and then reviewed by an experienced pathologist according to the WHO Blue book (2024) classification . Statistical Analysis The absolute and relative frequencies for qualitative variables were calculated for each group. Statistical analysis was performed using SPSS version 17 software (SPSS, Chicago, IL). The continuous variables are expressed as medians and ranges. Continuous data were compared using the MannWhitney U test. Pearson's 2 test or Fisher's exact test was used to analyze categoric data to compare proportions. All P values were two-tailed, and a P value of .05 was considered significant. Concordance between operators' NBI pattern was evaluated with Fleiss' fixed-marginal Kappa test (with Gwet's variance formula, 95% CI), considering values ≤0 as indicating no agreement, 0.01-0.20 as none to slight, 0.21-0.40 as fair, 0.41-0.60 as moderate, 0.61-0.80 as substantial and 0.81-1.00 as almost perfect agreement. ### Conditions Module **Conditions:** - Oral Squamous Cell Carcinoma - Oral Potentially Malignant Disorder **Keywords:** - narrow band imaging - OSCC - OPMD - NBI ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 480 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will undergo commone WLOE examination prior to do a required biopsy (see protocol for patients characteristics). **Intervention Names:** - Other: Biopsy for diagnostical purposes **Label:** White Light Oral Examination (WLOE) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Patients will have their biopsy guided by NBI (see protocol for patients characteristics). **Intervention Names:** - Other: Biopsy for diagnostical purposes **Label:** Narrow Band Imaging (NBI) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Narrow Band Imaging (NBI) - White Light Oral Examination (WLOE) **Description:** Incisional biopsy is the current golden standard for OPMD/OSCC diagnosis. Yet, the site it shall be performed is choosen by clinician at naked eyes. We will compare and study the results of performing the common golden standard biopsy site when guided by NBI. **Name:** Biopsy for diagnostical purposes **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Comparison of detection rates WLOE vs. NBI **Measure:** Detection rates of OPMD and OSCC **Time Frame:** through study completion, an average of 2 year #### Secondary Outcomes **Description:** N° of true positives OSCC detected by WLOE divided by (true positives + false negatives) vs. same data for NBI **Measure:** sensitivity **Time Frame:** through study completion, an average of 2 year **Description:** n° true negatives OSCC detected by WLOE divided by (true negatives+false positives) vs. same data for NBI **Measure:** specificity **Time Frame:** through study completion, an average of 2 year **Description:** N° of true positives OSCC detected by WLOE divided by (true positives + false positives) vs. same data for NBI **Measure:** NPV **Time Frame:** through study completion, an average of 2 year **Description:** n° true negatives OSCC detected by WLOE divided by (true negatives+false negatives)vs. same data for NBI **Measure:** PPV **Time Frame:** through study completion, an average of 2 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with soft tissue, mucosal lesions of the oral cavity, who arrive for an initial first diagnosis (group 1); * Patients with history OPMD (clinically evident lesion/s group 2a, lesion/s excised group 2b), who are in follow-up (OPMDs included are eg. Leukoplakia, erythroleukoplakia, erythroplakia, oral lichen planus, oral lichenoid lesion); * Patients with history of HNSCC (OSCC group 3a, sinonasal, nasopharynx, oropharynx, larynx, oesophagus group 3b); * High risk (see above) individuals with no known oral mucosal disease (group 4); Exclusion Criteria: * patients who did not need a biopsy nor after WLOE (e.g. normal mucosa, anatomical variation) nor after NBI (pattern I) * patients who, despite indication, were not suitable to undergo biopsy given his / her systemic conditions **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Napoli **Contacts:** ***Contact 1:*** - **Email:** agostino.guida@aocardarelli.it - **Name:** Agostino Guida, DMD, PhD, MSc - **Phone:** +393333835451 - **Role:** CONTACT **Country:** Italy **Facility:** Agostino Guida **Zip:** 80131 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000018307 - Term: Neoplasms, Squamous Cell - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000009371 - Term: Neoplasms by Site ### 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: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M5550 - Name: Carcinoma, Squamous Cell - Relevance: HIGH - As Found: Squamous Cell Carcinoma - ID: M1689 - Name: Squamous Cell Carcinoma of Head and Neck - Relevance: HIGH - As Found: Oral Squamous Cell Carcinoma - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M20451 - Name: Neoplasms, Squamous Cell - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown - ID: T4267 - Name: Oral Squamous Cell Carcinoma - Relevance: HIGH - As Found: Oral Squamous Cell Carcinoma ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000002294 - Term: Carcinoma, Squamous Cell - ID: D000077195 - Term: Squamous Cell Carcinoma of Head and Neck ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438926 **Brief Title:** Prevalence of Dental Caries in Patients With Dental Crowding **Official Title:** Prevalence of Dental Caries in Patients With Dental Crowding #### Organization Study ID Info **ID:** Caries with dental crowding #### Organization **Class:** OTHER **Full Name:** Cairo University ### Status Module #### Completion Date **Date:** 2025-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-09 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cairo University #### Responsible Party **Investigator Affiliation:** Cairo University **Investigator Full Name:** Reem Mohamed Mossaad **Investigator Title:** Principal investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Dental crowding causes limited access for the toothbrush, and the natural cleansing effect of the teeth by the tongue and saliva is also limited. This malposition allows for prolonged food accumulation, bacterial and plaque retention, which are important factors for the initiation and progression of dental caries. **Detailed Description:** Dental crowding causes limited access for the toothbrush, and the natural cleansing effect of the teeth by the tongue and saliva is also limited. This malposition allows for prolonged food accumulation, bacterial and plaque retention, which are important factors for the initiation and progression of dental caries . According to the World Health Organization, the main dental problems should be subjected to periodic epidemiological surveys. Knowledge of a population's epidemiological situation is vital for planning and providing prevention and treatment services . However, only few studies investigated the correlation between caries and crowding.Yet, their findings were inconsistent and still contradictory. Previous systematic review concluded that there is no reliable evidence regarding the association between dental caries and crowding and further studies with adequate sample size are required. Another systematic review found an association between caries and crowding but only in the adolescent group . As caries is a preventable disease, improving the understanding of this possible association would be beneficial for dental practitioners, public health policy makers and the general population as it will help in the application of medical model. This Cross-sectional study can detect one of predictors of dental caries early as crowding so the dentists can prohibit future carious lesions \& help in caries prevention through orthodontic treatment \& proper oral hygiene measures. ### Conditions Module **Conditions:** - Caries ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 325 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** DMF index developed by WHO health organization using numbered scores **Measure:** Dental Caries **Time Frame:** throughout study completion an average of 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Young adults range from 12-30 years. * Females or Males. * Anterior dental crowding. Exclusion Criteria: * Patients undergoing orthodontic treatment. * Patients who have any missing anterior teeth. * Patients who have any physical or mental disabilities. **Healthy Volunteers:** True **Maximum Age:** 30 Years **Minimum Age:** 12 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT **Study Population:** Young adults range from 12-30 years,Females or Males with anterior dental crowding. ### References Module #### References **Citation:** Hafez HS, Shaarawy SM, Al-Sakiti AA, Mostafa YA. Dental crowding as a caries risk factor: a systematic review. Am J Orthod Dentofacial Orthop. 2012 Oct;142(4):443-50. doi: 10.1016/j.ajodo.2012.04.018. **PMID:** 22999666 **Citation:** Caplin JL, Evans CA, Begole EA. The Relationship between Caries and Malocclusion in Chinese Migrant Workers' Children in Shanghai. Chin J Dent Res. 2015;18(2):103-10. **PMID:** 26167548 ## 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 ### 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 ### 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:** NCT06438913 **Brief Title:** Tezepelumab Treatment in Korean Severe Asthma Patients **Official Title:** The Improvement of Cough Outcomes After Tezepelumab Treatment in Korean Severe Asthma Patients With Airway Hyperresponsiveness #### Organization Study ID Info **ID:** 2024-0215 #### Organization **Class:** OTHER **Full Name:** Asan Medical Center ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-12 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Asan Medical Center #### Responsible Party **Investigator Affiliation:** Asan Medical Center **Investigator Full Name:** Tae-Bum Kim **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:** False ### Description Module **Brief Summary:** There is no study that systematically evaluated the effect of Tezepelumab on cough, and based on this background, the present researchers aimed to evaluate the effect of Tezepelumab treatment in patients with severe asthma who complain of cough using the Leicester Cough Questionnaire, a cough-related quality of life measurement tool. ### Conditions Module **Conditions:** - Asthma ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Year ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Tezepelumab blocks thymic stromal lymphopoietin (TSLP), an epithelial cytokine suggested to be important in the initiation and continuation of airway inflammation. **Name:** Tezepelumab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The effectiveness of Tezepelumab on cough was assessed by comparing the LCQ score at 1 and 12 months of administration with the LCQ score at the time of registration. **Measure:** Effects of Tezepeluma on Cough **Time Frame:** 1years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Severe asthma patients aged 19 or older and 79 or younger 2. Cases diagnosed as asthma by an expert and classified as severe asthma according to the 2014 ATS/ERS guidelines - Patients who require the use of high-dose inhaled steroids and additional control agents or systemic steroids for more than 50% of the year to control symptoms. Or, if asthma is not controlled even with the medication. Here, uncontrolled asthma means that any one of the following is satisfied. 1. ACT score less than 20 or 'not well controlled' according to GINA guideline 2. frequent exacerbations; Requires systemic steroid administration (over 3 consecutive days) more than twice in the previous year If you did 3. severe exacerbation; A condition that required hospitalization, admission to an intensive care unit, or application of a ventilator in the previous year If you have been angry at least once 4. airflow restrictions; FEV1 \< 80% 3. If a cough is due to asthma according to a doctor and the cough onset scale (cough visual analogue scale, cough VAS) satisfies 30 or more points out of 100. 4. If a positive result is confirmed in the methacholine (or mannitol) bronchial challenge test (if the bronchial challenge test result is not available or the test is difficult to proceed, it can be replaced with a positive bronchodilator response test) Exclusion Criteria: 1. Minors under 19 years of age, senior citizens over 79 years of age 2. If there is a history of use of other biological agents within 3 months prior to study registration 3. Cases where there was an acute exacerbation requiring a steroid burst (total 90mg prednisolone or more) during the 4-week screening period before study registration (possible for long-term prednisolone users) 4. Cases accompanied by clinically serious respiratory disease in addition to severe asthma 5. When accompanied by hypereosinophilic syndrome, ABPA, EGPA 6. When it is difficult to evaluate asthma alone due to severe respiratory disease 7. Pregnant women **Maximum Age:** 79 Years **Minimum Age:** 19 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** 1) ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001982 - Term: Bronchial Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000008171 - Term: Lung Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M4556 - Name: Asthma - Relevance: HIGH - As Found: Asthma - ID: M6590 - Name: Cough - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - 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: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001249 - Term: Asthma ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438900 **Acronym:** Westernage **Brief Title:** Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity **Official Title:** Fighting Western-diet Derived AGEs to Mitigate Muscle Wasting in Sarcobesity:Observational Study on the Relationship Between AGE Levels and Sarcobesity in an Adult Population Affected by Obesity and Type 2 Diabetes Mellitus #### Organization Study ID Info **ID:** CE049/2024 #### Organization **Class:** OTHER **Full Name:** Azienda Ospedaliero Universitaria Maggiore della Carita ### Status Module #### Completion Date **Date:** 2026-05-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Azienda Ospedaliero Universitaria Maggiore della Carita #### Responsible Party **Investigator Affiliation:** Azienda Ospedaliero Universitaria Maggiore della Carita **Investigator Full Name:** Flavia Prodam **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The study aims to explore whether a high level of AGEs (Advanced Glycation end products) derived from the diet may mediate diet-related muscle loss in Western-type diet, influencing the onset and progression of sarcopenia, predisposing to earlier and more severe metabolic consequences, including type 2 diabetes (T2D). The primary objective of the study is to investigate how the accumulation of AGEs is correlated with muscle loss in adult patients with obesity and type 2 diabetes or lipodystrophy in order to identify possible targets to mitigate the metabolic alterations caused by the Western diet (WD). Specifically, circulating AGEs levels on the skin will be evaluated and correlated with the stage of sarcopenia in a group of patients with obesity and a T2D diagnosis. Furthermore, the relationship between disease duration and AGE levels will be assessed. A secondary objective will be to analyze the clinical data obtained to identify metabolites and metabolic pathways responsible for the phenotype induced by the WD. The ultimate aim of the study is therefore to verify whether high levels of AGEs are correlated with an early and/or more pronounced onset of sarcopenia, concurrently with an increase in inflammation and oxidative stress. **Detailed Description:** The study in question is of a cross-sectional observational type. The reference population is defined by patients with obesity and a diagnosis of T2D within 15 years of entry into the study or patients with concomitant type 2 diabetes and lipodystrophy syndrome. This population was chosen because they are at high risk of sarcopenia. Lipodystrophy includes a heterogeneous spectrum of genetic and acquired diseases characterized by loss of subcutaneous adipose tissue, ectopic fat accumulation, insulin resistance, metabolic and cardiovascular diseases, premature aging, sarcopenia, muscle pain, high-grade inflammation, epigenetic dysregulation, and mitochondrial dysfunction. Therefore, patients with T2D and lipodystrophy are highly inflamed as they generally present with a more severe T2D phenotype, presumed sarcopenic, and with a high rate of endogenous AGE production. Patients with concurrent lipodystrophy and T2D will be recruited as sarcopenic and obese subjects, representing an excellent strategy for comparison with diabetic individuals without lipodystrophy. SUBJECTS AND METHODS A total of 195 consecutive subjects will be enrolled in the study from the Endocrinology Unit of the University of Eastern Piedmont between April 2024 and April 2026, who meet the inclusion criteria. Study duration: The study will last for two years corresponding to the enrollment period given the cross-sectional nature of the study. Statistical Analysis Descriptive statistics will be used to summarize sociodemographic, anthropometric, clinical, and lifestyle-related information collected. Categorical variables will be summarized using absolute frequencies and percentages, while numerical variables will be summarized using mean and standard deviation or median and interquartile range if not normally distributed according to the Shapiro-Wilk test and after observation of Q-Q plots (quantile-quantile plot). The Pearson correlation coefficient or the corresponding non-parametric Spearman rank correlation coefficient and confidence intervals will be initially calculated to assess the correlation between the levels of individual AGEs and skeletal muscle mass (SMM), handgrip strength (HGS), parameters of body composition, and functional parameters of skeletal muscle. Subsequently, linear regression models will be used to evaluate the relationship between AGEs and sarcopenia-defining indices adjusted for age, sex, duration of diabetes, and other potential confounding factors such as inflammation, adherence to the Western diet, and levels of physical activity. The LASSO method will be used for variable selection in multivariable regression models. Univariable and multivariable Poisson regression models with robust variance will be used to estimate relative prevalence risks for the association between AGEs and patient characteristics with sarcopenia presence and the corresponding confidence intervals. An integration of clinical data, biochemical data, AGE levels, and patient omic signatures will be performed to develop a multifactorial diagnostic model using multivariate statistical analysis (e.g., factor analysis, principal component analysis, cluster analysis, discriminant analysis, partial least squares analysis, logistic regression) and data-driven approaches. Machine learning algorithms will be applied to prioritize and weigh risk factors. These analyses will be conducted with internal statistical consultation already utilized by the group. Expected Results With this study, the investigators expect to obtain further information and correlations between nutritional assessment and its impact on inflammation, sarcopenia definition, and progression, obesity, and T2D, based on body measurements and clinical parameters. Through biochemical, hormonal, and metabolomic analyses conducted on biological samples, te investigators expect to identify possible markers related to the presence of AGEs. In conclusion, the primary expected outcome would be to identify a positive correlation between AGE accumulation in at least one compartment (skin, plasma, urine) and the severity of sarcopenia, thus obtaining a rapid and non-invasive method to identify individuals at high risk of developing muscle wasting (MW) and identify correlations between AGE levels and other metabolic characteristics, even in lipodystrophic pathology. ### Conditions Module **Conditions:** - Sarcopenia - Obesity **Keywords:** - Advanced glycation end products - Sarcobesity - Obesity - Sarcopenic ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 195 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Functional parameters of skeletal muscle defined by muscle strength measured through hand grip strength (HGS) The test requires the patient to tighten the handle the dynamometer with the maximum possible force, then maintaining the contraction for at least 5 seconds; you should repeat the test on the other hand (it is normal that the dominant expresses a higher force) and possibly repeat the test 2-3 times, with a break between different attempts, then going to calculate the average oh the kg moved with the dynamometer **Measure:** Skeletal mass functionality for sarcopenia definition **Time Frame:** evaluation of sarcopenia state through study completion, an average of 1 year **Description:** Functional parameters of skeletal muscle defined by the chair test: five-times sit-to-stand test; time duration 30-second chair stand test. You measure by considering the ability in seconds to get up and sit down from the chair properly **Measure:** Skeletall mass fuctionality for sarcopenia definition **Time Frame:** evaluation of sarcopenia state through study completion, an average of 1 year **Description:** The percentage of skeletal muscle mass relative to body mass will be considered. Skeletal mass will be calculated as follows: SM(Kg)=\[(h\^2/(BIA resistance)0.401)+(gender3.825)+(age\*0.071)\]+5.102 Where h indicates height measured in cm, gender is a dichotomous variable taking a value of 1 for males and 0 for females, and age is measured in years. From this measurement, the percentage of skeletal muscle mass (%SMM) will be calculated: %SMM=(SM (Kg))/(Body mass (Kg))\*100 **Measure:** Skeletall mass calculation for sarcopenia definition **Time Frame:** evaluation of sarcopenia state through study completion, an average of 1 year **Description:** According to consensus statement of European Society for Clinical Nutrition and Metabolism (ESPEN) and dell' European Association for the Study of Obesity (EASO) guidelines, individuals with altered skeletal muscle functionality parameters (HGS \< 16 kg for females and \< 27 kg for males or chair test \>15 seconds for both males and females \[27\]), altered %BF(body fat) (≥ 25% for males and ≥35% for females \[28\]), and altered %SMM (\<35.6% (≤28.7% severe sarcopenia) for males, \<28.4% (≤23% severe sarcopenia) for females) will be defined as sarcopenic. **Measure:** Number of participants with sarcopenia **Time Frame:** evaluation of sarcopenia state through study completion, an average of 1 year **Description:** AGE levels will be measured using skin fluorescence, using the "AGE reader mu" device (range from 1.3 to 5 level of AGEs respect to the patient's age). **Measure:** Advanced glycation end products quantification **Time Frame:** evaluation of AGEs through study completion, an average of 1 year **Description:** AGEs will also be assessed at the plasma level in free form (ELISA, fluorescence assay) or bound to hemoglobin (HbA1c clinical practice test), both measured in pg/mL **Measure:** Endogenous and exogenous AGEs plasma quantification **Time Frame:** evaluation of AGEs through study completion, an average of 1 year #### Secondary Outcomes **Description:** Gender, date of birth, date of diabetes diagnosis (for diabetic subjects) are assessed through questionnaires and medical record **Measure:** With questionnaires assessment of socio-demographic characteristics **Time Frame:** evaluation of socio-demographic characteristics through study completion, an average of 1 year **Description:** weight is assessed in Kg with the use of the bioimpedance balance **Measure:** Anthropometric measurements **Time Frame:** evaluation of weight and body composition through study completion, an average of 1 year **Description:** the height is measured in cm through a wall altimeter **Measure:** Anthropometric measurements **Time Frame:** evaluation of height through study completion, an average of 1 year **Description:** the BMI (body mass index) is calculated by making the ratio of the weight to the square of the height **Measure:** Anthropometric measurements **Time Frame:** evaluation of BMI (body mass index) through study completion, an average of 1 year **Description:** waist, hip, arm, and calf circumference are measured using an anelastic meter **Measure:** Anthropometric measurements **Time Frame:** evaluation of circumferences through study completion, an average of 1 year **Description:** Calculated using Alternative Healthy Eating Index-2010 (AHEI-2010) derived from basal metabolism assessment through fasting morning indirect calorimetry. **Measure:** Dietary Inflammatory Index (DII) **Time Frame:** evaluation of DII through study completion, an average of 1 year **Description:** Assessed with the use of questionnaire. EPIC is used for the bromatology evaluation of the diet, so there aren't scales but only indication about the macro and micronutrient composition. This is a qualitative questionnaires and not quantitative. **Measure:** Adherence level to the Western diet with European Prospective Investigation into Cancer and Nutrition (EPIC) questionnaires **Time Frame:** evaluation of DII through study completion, an average of 1 year **Description:** Assessed with the use of questionnaires. 24h recall questionnaire is used for the bromatology evaluation of the diet, so there aren't scales but only indication about the macro and micronutrient composition. This is a qualitative questionnaires and not quantitative. **Measure:** Adherence level to the Western diet with 24h recall questionnaires **Time Frame:** evaluation of DII through study completion, an average of 1 year **Description:** Physical activity is assessed using the International Physical Activity Questionnaire (IPAQ), which provides results in Metabolic Equivalent of Tasks (METs). The questions refer to activities over the past 7 days, including work, transportation, and leisure time. Moderate physical activity: Requires moderate effort and a slightly higher breathing rate than normal. One can speak but not sing during this activity. Intense physical activity: Requires significant effort and a much higher breathing rate, causing sweating and making it difficult to talk. The METs scale is as follows: Less than 700 METs: Inactive 700 to 2519 METs: Sufficiently active More than 2520 METs: Active **Measure:** Level of physical activity, related to sarcopenia,using a questionnaire **Time Frame:** evaluation of METs through study completion, an average of 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients of both sexes. * Adults. * BMI compatible with obesity and a diagnosis of type 2 diabetes under good metabolic control (HbA1c \< 7.5%) within 15 years of entry into the study or diagnosis of lipodystrophy (included in the European Consortium of Lipodystrophies (ECLip) Registry (eclip-web.org)) Exclusion Criteria: * Age under 18 years. * Secondary obesity or genetic diseases (Prader-Willi Syndrome, Down Syndrome); metabolic and endocrine disorders (Cushing's syndrome, hypothyroidism). * Subjects with: Inflammatory Bowel Disease (IBD), cancer. * Confirmed or planned pregnancy during the study participation months. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Given a type I error rate (α) of 0.05 and a power of 80%, 195 subjects will be needed to observe a significant correlation between AGE levels and sarcobesity indices of at least 0.2. Considering the low prevalence of lipodystrophy and a recruitment duration of one year, approximately 35 subjects with this condition are expected to be included. The remaining 160 subjects will have diabetes and obesity. Furthermore, considering that the duration of diabetes may influence AGE levels and sarcobesity, both subjects with long-standing diabetes (80 patients) and those with less than one year of diagnosis (80 patients) will be selected, which can be considered comparable to subjects in pre-diabetes. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** flavia.prodam@med.uniupo.it **Name:** Flavia Prodam, MD PhD **Phone:** +39-0321-660693 **Role:** CONTACT #### Locations **Location 1:** **City:** Novara **Country:** Italy **Facility:** SCDU Endocrinology, AOU Ospedale Maggiore della Carità **Zip:** 28100 #### Overall Officials **Official 1:** **Affiliation:** AOU Maggiore della Carità di Novara **Name:** Flavia Prodam, MD PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Frontera WR, Ochala J. Skeletal muscle: a brief review of structure and function. Calcif Tissue Int. 2015 Mar;96(3):183-95. doi: 10.1007/s00223-014-9915-y. Epub 2014 Oct 8. **PMID:** 25294644 **Citation:** Merz KE, Thurmond DC. Role of Skeletal Muscle in Insulin Resistance and Glucose Uptake. Compr Physiol. 2020 Jul 8;10(3):785-809. doi: 10.1002/cphy.c190029. **PMID:** 32940941 **Citation:** Bonaldo P, Sandri M. Cellular and molecular mechanisms of muscle atrophy. Dis Model Mech. 2013 Jan;6(1):25-39. doi: 10.1242/dmm.010389. **PMID:** 23268536 **Citation:** Cohen S, Nathan JA, Goldberg AL. Muscle wasting in disease: molecular mechanisms and promising therapies. Nat Rev Drug Discov. 2015 Jan;14(1):58-74. doi: 10.1038/nrd4467. **PMID:** 25549588 **Citation:** Dutt V, Gupta S, Dabur R, Injeti E, Mittal A. Skeletal muscle atrophy: Potential therapeutic agents and their mechanisms of action. Pharmacol Res. 2015 Sep;99:86-100. doi: 10.1016/j.phrs.2015.05.010. Epub 2015 Jun 2. **PMID:** 26048279 **Citation:** Lecker SH, Jagoe RT, Gilbert A, Gomes M, Baracos V, Bailey J, Price SR, Mitch WE, Goldberg AL. Multiple types of skeletal muscle atrophy involve a common program of changes in gene expression. FASEB J. 2004 Jan;18(1):39-51. doi: 10.1096/fj.03-0610com. **PMID:** 14718385 **Citation:** Hosseini Z, Whiting SJ, Vatanparast H. Current evidence on the association of the metabolic syndrome and dietary patterns in a global perspective. Nutr Res Rev. 2016 Dec;29(2):152-162. doi: 10.1017/S095442241600007X. **PMID:** 27955720 **Citation:** Tsilingiris D, Tzeravini E, Koliaki C, Dalamaga M, Kokkinos A. The Role of Mitochondrial Adaptation and Metabolic Flexibility in the Pathophysiology of Obesity and Insulin Resistance: an Updated Overview. Curr Obes Rep. 2021 Sep;10(3):191-213. doi: 10.1007/s13679-021-00434-0. Epub 2021 Apr 10. **PMID:** 33840072 **Citation:** Peppa M, Mavroeidi I. Experimental Animal Studies Support the Role of Dietary Advanced Glycation End Products in Health and Disease. Nutrients. 2021 Sep 29;13(10):3467. doi: 10.3390/nu13103467. **PMID:** 34684468 **Citation:** Muthyalaiah YS, Jonnalagadda B, John CM, Arockiasamy S. Impact of Advanced Glycation End products (AGEs) and its receptor (RAGE) on cancer metabolic signaling pathways and its progression. Glycoconj J. 2021 Dec;38(6):717-734. doi: 10.1007/s10719-021-10031-x. Epub 2022 Jan 22. **PMID:** 35064413 **Citation:** Mori H, Kuroda A, Ishizu M, Ohishi M, Takashi Y, Otsuka Y, Taniguchi S, Tamaki M, Kurahashi K, Yoshida S, Endo I, Aihara KI, Funaki M, Akehi Y, Matsuhisa M. Association of accumulated advanced glycation end-products with a high prevalence of sarcopenia and dynapenia in patients with type 2 diabetes. J Diabetes Investig. 2019 Sep;10(5):1332-1340. doi: 10.1111/jdi.13014. Epub 2019 Feb 19. **PMID:** 30677242 **Citation:** Waqas K, Chen J, Trajanoska K, Ikram MA, Uitterlinden AG, Rivadeneira F, Zillikens MC. Skin Autofluorescence, a Noninvasive Biomarker for Advanced Glycation End-products, Is Associated With Sarcopenia. J Clin Endocrinol Metab. 2022 Jan 18;107(2):e793-e803. doi: 10.1210/clinem/dgab632. **PMID:** 34453164 **Citation:** Chiu CY, Yang RS, Sheu ML, Chan DC, Yang TH, Tsai KS, Chiang CK, Liu SH. Advanced glycation end-products induce skeletal muscle atrophy and dysfunction in diabetic mice via a RAGE-mediated, AMPK-down-regulated, Akt pathway. J Pathol. 2016 Feb;238(3):470-82. doi: 10.1002/path.4674. Epub 2015 Dec 31. **PMID:** 26586640 **Citation:** Chiappalupi S, Sorci G, Vukasinovic A, Salvadori L, Sagheddu R, Coletti D, Renga G, Romani L, Donato R, Riuzzi F. Targeting RAGE prevents muscle wasting and prolongs survival in cancer cachexia. J Cachexia Sarcopenia Muscle. 2020 Aug;11(4):929-946. doi: 10.1002/jcsm.12561. Epub 2020 Mar 11. **PMID:** 32159297 **Citation:** Egawa T, Tsuda S, Goto A, Ohno Y, Yokoyama S, Goto K, Hayashi T. Potential involvement of dietary advanced glycation end products in impairment of skeletal muscle growth and muscle contractile function in mice. Br J Nutr. 2017 Jan;117(1):21-29. doi: 10.1017/S0007114516004591. Epub 2017 Jan 17. **PMID:** 28093090 **Citation:** Mastrocola R, Nigro D, Chiazza F, Medana C, Dal Bello F, Boccuzzi G, Collino M, Aragno M. Fructose-derived advanced glycation end-products drive lipogenesis and skeletal muscle reprogramming via SREBP-1c dysregulation in mice. Free Radic Biol Med. 2016 Feb;91:224-35. doi: 10.1016/j.freeradbiomed.2015.12.022. Epub 2015 Dec 22. **PMID:** 26721591 **Citation:** Clayton ZS, Gioscia-Ryan RA, Justice JN, Lubieniecki KL, Hutton DA, Rossman MJ, Zigler MC, Seals DR. Lifelong physical activity attenuates age- and Western-style diet-related declines in physical function and adverse changes in skeletal muscle mass and inflammation. Exp Gerontol. 2022 Jan;157:111632. doi: 10.1016/j.exger.2021.111632. Epub 2021 Nov 22. **PMID:** 34822971 **Citation:** Roseno SL, Davis PR, Bollinger LM, Powell JJ, Witczak CA, Brault JJ. Short-term, high-fat diet accelerates disuse atrophy and protein degradation in a muscle-specific manner in mice. Nutr Metab (Lond). 2015 Nov 4;12:39. doi: 10.1186/s12986-015-0037-y. eCollection 2015. **PMID:** 26539241 **Citation:** M V, Wang K. Dietary natural products as a potential inhibitor towards advanced glycation end products and hyperglycemic complications: A phytotherapy approaches. Biomed Pharmacother. 2021 Dec;144:112336. doi: 10.1016/j.biopha.2021.112336. Epub 2021 Oct 19. **PMID:** 34678719 **Citation:** Garvey WT. New Horizons. A New Paradigm for Treating to Target with Second-Generation Obesity Medications. J Clin Endocrinol Metab. 2022 Mar 24;107(4):e1339-e1347. doi: 10.1210/clinem/dgab848. **PMID:** 34865050 **Citation:** Donini LM, Busetto L, Bischoff SC, Cederholm T, Ballesteros-Pomar MD, Batsis JA, Bauer JM, Boirie Y, Cruz-Jentoft AJ, Dicker D, Frara S, Fruhbeck G, Genton L, Gepner Y, Giustina A, Gonzalez MC, Han HS, Heymsfield SB, Higashiguchi T, Laviano A, Lenzi A, Nyulasi I, Parrinello E, Poggiogalle E, Prado CM, Salvador J, Rolland Y, Santini F, Serlie MJ, Shi H, Sieber CC, Siervo M, Vettor R, Villareal DT, Volkert D, Yu J, Zamboni M, Barazzoni R. Definition and Diagnostic Criteria for Sarcopenic Obesity: ESPEN and EASO Consensus Statement. Obes Facts. 2022;15(3):321-335. doi: 10.1159/000521241. Epub 2022 Feb 23. **PMID:** 35196654 **Citation:** Donini LM, Poggiogalle E, Del Balzo V, Lubrano C, Faliva M, Opizzi A, Perna S, Pinto A, Rondanelli M. How to estimate fat mass in overweight and obese subjects. Int J Endocrinol. 2013;2013:285680. doi: 10.1155/2013/285680. Epub 2013 Apr 10. **PMID:** 23662101 **Citation:** De Rosa E, Santarpia L, Marra M, Sammarco R, Amato V, Onufrio M, De Simone G, Contaldo F, Pasanisi F. Preliminary evaluation of the prevalence of sarcopenia in obese patients from Southern Italy. Nutrition. 2015 Jan;31(1):79-83. doi: 10.1016/j.nut.2014.04.025. Epub 2014 May 10. **PMID:** 25441590 ## Document Section ### Large Document Module #### Large Docs - Date: 2024-04-15 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 354689 - Type Abbrev: Prot_SAP - Upload Date: 2024-05-09T09:20 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000050177 - Term: Overweight - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight - ID: D000020879 - Term: Neuromuscular Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000001284 - Term: Atrophy - ID: D000020763 - Term: Pathological Conditions, Anatomical ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: LOW - As Found: Unknown - ID: M12701 - Name: Obesity - Relevance: HIGH - As Found: Obesity - ID: M21265 - Name: Wasting Syndrome - Relevance: LOW - As Found: Unknown - ID: M5363 - Name: Cachexia - Relevance: LOW - As Found: Unknown - ID: M28396 - Name: Sarcopenia - Relevance: HIGH - As Found: Sarcopenia - ID: M12090 - Name: Muscular Atrophy - Relevance: HIGH - As Found: Muscle Wasting - ID: M4589 - Name: Atrophy - Relevance: LOW - As Found: Unknown - ID: M26186 - Name: Overweight - Relevance: LOW - As Found: Unknown - ID: M25307 - Name: Overnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown - ID: M22619 - Name: Neuromuscular Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000055948 - Term: Sarcopenia - ID: D000009133 - Term: Muscular Atrophy - ID: D000009765 - Term: Obesity ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438887 **Brief Title:** Strategic Ingestion of Creatine Supplementation and Resistance Training in Trained Young Adults **Official Title:** Strategic Ingestion of Creatine Supplementation and Resistance Training in Trained Young Adults #### Organization Study ID Info **ID:** Bio-REB 4641 #### Organization **Class:** OTHER **Full Name:** University of Regina ### Status Module #### Completion Date **Date:** 2025-08-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Regina #### Responsible Party **Investigator Affiliation:** University of Regina **Investigator Full Name:** Darren Candow **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:** Creatine supplementation improves measures of muscle accretion and performance compared to placebo during a resistance training program. However, the optimal creatine supplementation protocol for maximizing these improvements is unknown. **Detailed Description:** Creatine is a naturally occurring nitrogen containing compound endogenously produced in the body through reactions involving the amino acids arginine, glycine and methionine. Alternatively, creatine can be consumed in the diet (primarily from red meat and seafood) or through commercially manufactured creatine. It has been proposed that the strategic ingestion of creatine supplementation may be an important factor to consider during a resistance training program to increase muscle growth and performance. There is evidence that creatine supplementation only on training days has greater muscle benefits compared to placebo in healthy older adults. However, the effects of creatine on training days (compared to creatine on non-training days or placebo) in healthy young adults is unknown. Further, pre- and post-exercise creatine supplementation appears to produce similar muscle benefits (compared to placebo) in healthy older adults. It remains to be determined whether the timing of creatine ingestion (immediately before vs. immediately following training sessions) influences the physiological adaptations from resistance training compared to placebo in young healthy adults. It is also unknown whether differences exist in supplementing with creatine immediately before, during or immediately following resistance training sessions in young healthy adults. ### Conditions Module **Conditions:** - Strength - Muscle ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Double-blind, randomized controlled trial ##### Masking Info **Masking:** TRIPLE **Masking Description:** blinding **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 52 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 5 grams of creatine monohydrate + 3 grams of placebo immediately before training sessions; 8 grams of placebo immediately after training sessions; 8 grams of placebo on non-training days. **Intervention Names:** - Dietary Supplement: Placebo - Dietary Supplement: Creatine monohydrate **Label:** Creatine Before Training **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 5 grams of creatine monohydrate + 3 grams of placebo immediately after training sessions; 8 grams of placebo immediately before training sessions; 8 grams of placebo on non-training days. **Intervention Names:** - Dietary Supplement: Placebo - Dietary Supplement: Creatine monohydrate **Label:** Creatine After Training **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** 5 grams of creatine monohydrate + 3 grams of placebo on non-training days; 8 grams of placebo immediately before training sessions; 8 grams of placebo immediately after training sessions. **Intervention Names:** - Dietary Supplement: Placebo - Dietary Supplement: Creatine monohydrate **Label:** Creatine Non-Training **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** 8 grams of placebo immediately before training sessions; 8 grams of placebo immediately after training sessions; 8 grams of placebo on non-training days **Intervention Names:** - Dietary Supplement: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Creatine After Training - Creatine Before Training - Creatine Non-Training - Placebo **Description:** Corn-Starch Maltodextrin **Name:** Placebo **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Creatine After Training - Creatine Before Training - Creatine Non-Training **Description:** Creatine **Name:** Creatine monohydrate **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Whole-body lean mass (kg) using bioelectrical impedance analysis **Measure:** Body Composition **Time Frame:** baseline, week 16 **Description:** Muscle thickness of the biceps, triceps, quadriceps, hamstrings and calf muscle using B-mode ultrasound (cm) **Measure:** Muscle Hypertrophy **Time Frame:** baseline, week 16 **Description:** 1-repetition maximum leg press and chest press (kg) **Measure:** Strength **Time Frame:** baseline, week 16 **Description:** Repetitions to fatigue for leg press and chest press (total number) **Measure:** Endurance **Time Frame:** baseline, week 16 **Description:** Medicine ball throw (cm) **Measure:** Power **Time Frame:** baseline, week 16 **Description:** Total body water (kg) using bioelectrical impedance analysis **Measure:** Hydration **Time Frame:** baseline, week 16 **Description:** Vertical jump (watts) **Measure:** Power **Time Frame:** baseline, weekn 16 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Physically active (performing structured resistance training \> 2x/week for ≥ 4 weeks) * Males and females (age 18-39) Exclusion Criteria: * Pregnant or nursing * Have consumed creatine monohydrate within 30 days prior to the start of the study * Pre-existing allergies to the placebo **Healthy Volunteers:** True **Maximum Age:** 39 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Darren.Candow@uregina.ca **Name:** Darren Candow **Phone:** 3062090280 **Role:** CONTACT #### Locations **Location 1:** **City:** Regina **Contacts:** ***Contact 1:*** - **Email:** Darren.Candow@uregina.ca - **Name:** Darren G Candow, PhD - **Phone:** 3062090280 - **Role:** CONTACT ***Contact 2:*** - **Name:** Darren G Candow, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Canada **Facility:** University of Regina **State:** Saskatchewan **Status:** RECRUITING **Zip:** S4S4H4 **Location 2:** **City:** Regina **Contacts:** ***Contact 1:*** - **Email:** Darren.Candow@uregina.ca - **Name:** Darren Candow - **Role:** CONTACT **Country:** Canada **Facility:** University of Regina **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** University of Regina **Name:** Darren Candow **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Ot - Name: Other Dietary Supplements - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T385 - Name: Creatine - Relevance: HIGH - As Found: Hold ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438874 **Brief Title:** Type 2 Diabetes Post Exercise Arterial Stiffness **Official Title:** Type 2 Diabetes Post Exercise Arterial Stiffness #### Organization Study ID Info **ID:** STUDY2024-0610 #### Organization **Class:** OTHER **Full Name:** University of Illinois at Chicago ### Status Module #### Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Illinois at Chicago #### 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 overall aim of this research proposal is to determine the impact of GLP1 agonists on post-exercise arterial stiffness. Therefore, the investigators will examine the cardiovascular responses to exercise in individuals with Type 2 Diabetes mellitus (T2DM) taking these medications during and following a graded maximal exercise test. **Detailed Description:** Type 2 diabetes mellitus (T2DM) is a significant public health concern associated with increased cardiovascular morbidity and mortality. Notably, individuals with T2DM often exhibit increased arterial stiffness, a key indicator of cardiovascular risk. Pharmacological interventions such as GLP1 agonists have emerged as crucial treatments for T2DM, offering glycemic control and potential cardiovascular benefits, including improvements in blood pressure and arterial stiffness. However, while the effects of GLP1 agonists on glycemic control and blood pressure regulation have been explored, their impact on arterial stiffness, specifically in response to exercise, remains largely unexplored in individuals with T2DM. Arterial stiffness is a critical marker of cardiovascular health, and its reduction is associated with decreased cardiovascular risk which include lowered blood pressure. Therefore, the overall aim of this research is to investigate whether GLP1 agonists attenuate arterial stiffness post exercise and reduce peak exercise blood pressure in individuals with T2DM. ### Conditions Module **Conditions:** - Type 2 Diabetes ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** The study will involve individuals diagnosed with type 2 diabetes mellitus (T2DM) who are currently receiving treatment with a glucagon-like peptide 1 (GLP1) agonist compared to a control group of individuals diagnosed with type 2 diabetes mellitus (T2DM) who are receiving treatment with drugs other than glucagon-like peptide 1 (GLP1) agonists. The study will not involve changes to medications for the participants. ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Individuals diagnosed with type 2 diabetes mellitus (T2DM) who are currently receiving treatment with a glucagon-like peptide 1 (GLP1) agonist. **Intervention Names:** - Other: Exercise Test **Label:** GLP-1 Treatment **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - GLP-1 Treatment **Description:** Exercise capacity will be measured as peak oxygen consumption (peakVO2) using an incremental exercise test on a cycle ergometer with an open-circuit spirometry system (TrueOne, Parvo Medics, Sandy, UT) to analyze expired gases. Exercise testing will follow the American College of Sports Medicine and American Heart Association guidelines. The investigators will use a graded protocol, starting with a warm-up at 0 watts for 5 minutes, followed by 15 watt increments every 2 minutes until volitional fatigue. **Name:** Exercise Test **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Measured via pulse wave velocity **Measure:** Arterial stiffness **Time Frame:** Baseline and up to 20 minutes post exercise #### Secondary Outcomes **Description:** Peak exercise blood pressure **Measure:** Blood pressure **Time Frame:** Through exercise test completion, an average of 10 minutes ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Individuals diagnosed with type 2 diabetes mellitus (T2DM). * Age between 18 and 60 years old. * Currently receiving treatment with a glucagon-like peptide 1 (GLP1) agonist for the management of T2DM for a minimum duration of six months. * For control group no current use of a glucagon-like peptide 1 (GLP1) agonist for the management of type 2 diabetes mellitus (T2DM). * HbA1c levels between 6.5-8% * Body Mass Index (BMI) within the range of 25 to 40 kg/m2. Exclusion Criteria: * Coronary heart disease. * Pulmonary disease (e.g. asthma, chronic obstructive pulmonary disease) * Neurological disorders (e.g. Alzheimer's disease, dementia) * Congestive heart failure. * Peripheral vascular disease. * Liver failure. * Kidney failure. * Alcohol abuse. * Drug abuse. * Smoking. * Hypertension (defined as Systolic Blood Pressure ≥ 140 mmHg or Diastolic Blood Pressure ≥ 90 mmHg) * Insulin therapy for the management of T2DM * Severe obesity (defined as Body Mass Index \>40 kg/m2); * Pregnancy * Non-English speaking individuals **Healthy Volunteers:** True **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** rjacks40@uic.edu **Name:** Ronald E Jackson, PhD **Phone:** 708-536-0594 **Role:** CONTACT **Contact 2:** **Email:** psc@uic.edu **Name:** Philip Clifford, PhD **Phone:** 414-975-6782 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** University of Illinois Chicago **Name:** Ronald E Jackson, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: HIGH - As Found: Type 2 Diabetes - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003924 - Term: Diabetes Mellitus, Type 2 ### Intervention Browse Module - Browse Branches - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M9043 - Name: Glucagon - Relevance: LOW - As Found: Unknown - ID: M26997 - Name: Glucagon-Like Peptide 1 - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438861 **Brief Title:** Role of Combination Therapy in Women With Refractory Overactive Bladder **Official Title:** Exploring the Additive Effect of Vibegron to Intradetrusor OnabotulinumtoxinA in Women With Refractory Overactive Bladder #### Organization Study ID Info **ID:** IRB-300012698 #### Organization **Class:** OTHER **Full Name:** University of Alabama at Birmingham #### Secondary ID Infos **Domain:** Pending **ID:** Pending **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2026-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-09 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Alabama at Birmingham #### Responsible Party **Investigator Affiliation:** University of Alabama at Birmingham **Investigator Full Name:** Katelyn Donaldson, MD **Investigator Title:** Urogynecology Fellow **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:** Defined by the International Continence Society (ICS) as urinary "urgency, with or without urge incontinence, usually with frequency and nocturia", overactive bladder (OAB) presents as challenging syndrome to treat. OAB is a very prevalent condition, affecting between 11.8% to 16% of the population with equal impact on women and men and growing prevalence with age. OAB is associated with a significant financial burden to both patients and the health care system with a estimated cost of US $82.6 billion in 2020. Traditionally, a stepwise approach has been taken in managing OAB; starting first with lifestyle modifications, followed by anticholinergic or beta-3-agonist medications as the second line, and lastly, intradetrusor onabotulinumtoxinA injections, percutaneous tibial nerve stimulation (PTNS), and sacral neuromodulation (SNM) as third line options. Given the limitations of this stepwise approach in patients with refractory OAB, combination therapy offers patients an increasing number of treatment options but the literature surrounding the efficacy of combination therapy is somewhat limited. A 2019 systematic review revealed there were only 32 studies in the current OAB literature that explored the role of combination therapy, and the majority of these studies examined the effect of lifestyle modifications with another intervention strategy, highlighting an untapped area of research5. To date, there has only been a single pilot study conducted in Taiwan examining the effect of intradetrusor onabotulinumtoxinA injections with the addition of mirabegron for patients with refractory OAB. This study by Wang et al. explored the therapeutic impact of adding either an anticholinergic, solifenacin, or a beta-3 agonist, mirabegron, to intradetrusor onabotulinumtoxinA injections as compared to each other as well as patients receiving onabotulinumtoxinA alone. Ninety patients were enrolled with 30 patients allocated to the solifenacin arm, 31 to the mirabegron arm, and 29 to the control group. While the baseline data among the three arms was comparable, the percentage of OAB wet in the mirabegron plus onabotulinumtoxinA group was significantly less at 3-, 6-, 9-, and 12-month intervals than the solifenacin plus onabotulinumtoxinA and the onabotulinumtoxinA alone groups. While this pilot study reveals the potential additive benefit of a beta-3 agonist to intradetrusor onabotulinumtoxinA, no further studies have been performed to date and there are no studies regarding the additive benefit of vibegron, which has a more tolerable side effect profile and is not as limited by as many contraindications as mirabegron. If vibegron can potentiate the effect of intradetrusor onabotulinumtoxinA, this presents a new treatment strategy for OAB and could offer patients an additional line of therapy before having to pursue more invasive and costly management option of sacral neuro modulation. **Detailed Description:** The study will be a prospective double-blinded randomized control trial to examine the effect of administering vibegron versus placebo in conjunction with intradetrusor onabotulinumtoxinA injections for the management of refractory OAB. Patients who present to the University of Alabama at Birmingham urogynecology practice with refractory OAB undergoing the standard 100U intradetrusor onabotulinumtoxinA will be offered enrollment to either the onabotulinumtoxinA plus vibegron or the onabotulinumtoxinA plus placebo groups. Prior to onabotulinumtoxinA injections, patients' baseline demographics will be documented and their genitourinary symptoms will be assessed using the previously validated Urinary Distress Inventory Short Form (UDI-6), the Incontinence Impact Questionnaire Short Form (IIQ-7), the Overactive Bladder Questionnaire (The OAB-q), and a 3 day voiding diary. Patients will be blinded to which cohort they are randomized to. Each patient will undergo intradetrusor onabotulinumtoxinA injections of 100U either in the office or in the operating room depending on patient and provider preference. Patients will begin taking vibegron or a placebo pill daily starting the day of their procedure. At 12 weeks, patients will complete a 3 day voiding diary as well as the UDI-6, IIQ-7, and OAB-q questionnaires. Patient charts will be queried for timing of repeat onabotulinumtoxinA injection as another secondary outcome. Primary outcome: Change in mean urinary urgency incontinence episodes at 12 weeks based on 3 day voiding diary Secondary outcomes: Mean change in UDI-6 responses at 12 weeks, mean change in IIQ-7 responses at 12 weeks, mean change in OAB-q responses at 12 weeks, duration to repeat onabotulinumtoxinA injection Sample Size Calculation: It is anticipated that women randomized to the 100U intradetrusor onabotulinumtoxinA plus vibegron arm will experience a greater improvement in UUI episodes compared to the 100U intradetrusor onabotulinumtoxinA plus placebo cohort. A recent study comparing the PTNS plus mirabegron to PTNS plus placebo performed a sample size calculation using existing data 7,8. In that calculation, a 2-sided alpha=0.05, the estimate for that difference in improvement had been estimated to be 2.5 UUI episodes over a 3-day bladder diary pre-vs. post-treatment with a standard deviation of 3 and a power of 0.80 and given the assumed attrition rate of 10%, the total N per arm was estimated to be 27 subjects for the study. Given the similarities between this study and our proposed study, the sample size calculation was felt be applicable to this study. ### Conditions Module **Conditions:** - Overactive Bladder Syndrome **Keywords:** - Refractory Overactive Bladder Syndrome ### 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:** 54 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Each patient will undergo intradetrusor onabotulinumtoxinA injections of 100U either in the office or in the operating room depending on patient and provider preference. Patients randomized to this arm will begin taking vibegron 75mg daily, which is the standard dose, starting the day of their procedure and continue for 3 months. **Intervention Names:** - Drug: Vibegron 75mg **Label:** 100U intradetrusor onabotulinumtoxinA plus vibegron **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Each patient will undergo intradetrusor onabotulinumtoxinA injections of 100U either in the office or in the operating room depending on patient and provider preference. Patients randomized to this arm will begin taking a placebo pill daily starting the day of their procedure and continue for 3 months. **Intervention Names:** - Drug: Placebo **Label:** 100U intradetrusor onabotulinumtoxinA plus placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - 100U intradetrusor onabotulinumtoxinA plus vibegron **Description:** Each patient will undergo intradetrusor onabotulinumtoxinA injections of 100U either in the office or in the operating room depending on patient and provider preference. Patients will begin taking vibegron 75mg daily or a placebo pill daily starting the day of their procedure and continue for 3 months. **Name:** Vibegron 75mg **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - 100U intradetrusor onabotulinumtoxinA plus placebo **Description:** Each patient will undergo intradetrusor onabotulinumtoxinA injections of 100U either in the office or in the operating room depending on patient and provider preference. Patients will begin taking vibegron 75mg daily or a placebo pill daily starting the day of their procedure and continue for 3 months. **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Patients will be asked to complete a 3 day voiding diary at baseline and at 12 weeks following intradetrusor onabotulinumtoxinA injections and oral medication. The mean change in UUI episodes will be compared between the onabotulinumtoxinA injection plus vibegron verus onabotulinumtoxinA injection plus placebo groups. **Measure:** Change in urinary urgency incontinence (UUI) episodes on 3 day voiding diary at 12 weeks after starting treatment as compared to baseline **Time Frame:** Pre-intervention baseline to 12 weeks following initiation of intervention #### Secondary Outcomes **Description:** The UDI-6 is the short form validated patient questionnaire that was developed from the urogenital distress inventory (UDI). It consists of six questions that focus on lower urinary tract dysfunction including obstructive, irritative, and stress symptoms. The responses are scored as follows: (0) not at all, (1) slightly, (2) moderately, (3) greatly. The mean score is multiplied by 33 1/3 to convert to a 0 to 100 scale with higher scores indicative of more symptoms distress. Subjects will complete the UDI-6 survey at baseline and at 12 weeks post-intervention. The mean change in UDI-6 responses will be compared. **Measure:** Change in Symptom Distress as Measured by the Urogenital Distress Index (UDI-6) Questionnaire Pre-Intervention versus 12 weeks Post-Intervention **Time Frame:** Pre-intervention baseline to 12 weeks following initiation of intervention **Description:** The IIQ-7 is the short form validated patient questionnaire that was developed from the incontinence impact questionnaire (IIQ). It consists of seven questions that focus on the impact of UUI on physical activity, travel, relationships, and emotional health. The responses are scored as follows: (0) not at all, (1) slightly, (2) moderately, (3) greatly. The mean score is multiplied by 33 1/3 to convert to a 0 to 100 scale with higher scores indicative of more symptoms distress. Subjects will complete the IIQ-7 survey at baseline and at 12 weeks post-intervention. The mean change in IIQ-7 responses will be compared. **Measure:** Change in UUI (Urge Urinary Incontinence)/OAB (Overactive Bladder) Quality of Life as Measured by the Incontinence Impact Questionnaire Short Form (IIQ-7) Questionnaire Pre-Intervention versus 12 weeks Post-Intervention **Time Frame:** Pre-intervention baseline to 12 weeks following initiation of intervention **Description:** The OAB-q SF is the short form validated patient questionnaire that was developed from the Overactive Bladder Questionnaire (OAB-q). It consists of six questions that focus on the impact of bladder symptoms over the past 4 weeks. The responses are scored as follows: (1) not at all, (2) a little bit, (3) somewhat, (4) quite a bit, (5) a great deal, (6) a very great deal. The mean score is converted to a 0 to 100 scale with higher scores indicative of more symptoms distress. Subjects will complete the OAB-q SF survey at baseline and at 12 weeks post-intervention. The mean change in OAB-q SF responses will be compared. **Measure:** hange in UUI (Urge Urinary Incontinence)/OAB (Overactive Bladder) Quality of Life as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF) Questionnaire Pre-Intervention versus 12 weeks Post-Intervention **Time Frame:** Pre-intervention baseline to 12 weeks following initiation of intervention **Description:** Patient require repeat intradetrusor onabotulinumtoxinA injection to treat refractory OAB. A chart review will be performed to determine time interval between initial onabotulinumtoxinA injection and subsequent injection to see if there is a difference with the addition of vibegron as compared to placebo. **Measure:** Duration to repeat onabotulinumtoxinA injection **Time Frame:** Initiation of intervention until repeat injection, anticipate average of 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Women undergoing intradetrusor botulinum injections for refractory OAB 2. Age 18 years old or greater 3. Fluency and literacy in English 4. Capacity to provide consent Exclusion Criteria: 1. Allergy to Vibegron 2. Currently pregnant or planning to become pregnant 3. Breastfeeding 4. Current digoxin use **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available. **PMID:** 12559262 **Citation:** Coyne KS, Wein A, Nicholson S, Kvasz M, Chen CI, Milsom I. Economic burden of urgency urinary incontinence in the United States: a systematic review. J Manag Care Pharm. 2014 Feb;20(2):130-40. doi: 10.18553/jmcp.2014.20.2.130. **PMID:** 24456314 **Citation:** Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2. **PMID:** 17049716 **Citation:** Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, Hunt TL, Wein AJ. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003 May;20(6):327-36. doi: 10.1007/s00345-002-0301-4. Epub 2002 Nov 15. **PMID:** 12811491 **Citation:** Kasman A, Stave C, Elliott CS. Combination therapy in overactive bladder-untapped research opportunities: A systematic review of the literature. Neurourol Urodyn. 2019 Nov;38(8):2083-2092. doi: 10.1002/nau.24158. Epub 2019 Sep 4. **PMID:** 31483070 **Citation:** Wang CC, Lee CL, Hwang YT, Kuo HC. Adding mirabegron after intravesical onabotulinumtoxinA injection improves therapeutic effects in patients with refractory overactive bladder. Low Urin Tract Symptoms. 2021 Oct;13(4):440-447. doi: 10.1111/luts.12384. Epub 2021 May 6. **PMID:** 33960119 **Citation:** Sancaktar M, Ceyhan ST, Akyol I, Muhcu M, Alanbay I, Mutlu Ercan C, Atay V. The outcome of adding peripheral neuromodulation (Stoller afferent neuro-stimulation) to anti-muscarinic therapy in women with severe overactive bladder. Gynecol Endocrinol. 2010 Oct;26(10):729-32. doi: 10.3109/09513591003649815. **PMID:** 20210697 **Citation:** Stanley R, Richter HE, Meyer I, Blanchard C. Posterior Tibial Nerve Stimulation With versus Without Mirabegron in Women with Refractory UUI and OAB-wet: A Randomized Controlled Trial. International Continence Society 2023; 2023; Toronto, Canada. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001745 - Term: Urinary Bladder Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000059411 - Term: Lower Urinary Tract Symptoms - ID: D000020924 - Term: Urological Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M27167 - Name: Urinary Bladder, Overactive - Relevance: HIGH - As Found: Overactive Bladder - ID: M5026 - Name: Urinary Bladder Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M29464 - Name: Lower Urinary Tract Symptoms - Relevance: LOW - As Found: Unknown - ID: M22659 - Name: Urological Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000053201 - Term: Urinary Bladder, Overactive ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21257 - Name: Botulinum Toxins, Type A - Relevance: LOW - As Found: Unknown - ID: M250193 - Name: abobotulinumtoxinA - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438848 **Brief Title:** Effects of Lymph Drainage on Patients With Axillary Web Syndrome **Official Title:** Effects of a Physical Therapy Program Combined With Manual Lymphatic Drainage on Shoulder Function, , and Pain in Breast Cancer Patients With Axillary Web Syndrome Following Axillary Dissection: A Randomized Controlled Trial #### Organization Study ID Info **ID:** 24-1241 #### Organization **Class:** OTHER **Full Name:** Taif University ### Status Module #### Completion Date **Date:** 2024-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Taif University #### Responsible Party **Investigator Affiliation:** Taif University **Investigator Full Name:** Ibrahim Mohammad Alkayshan **Investigator Title:** Physical therapist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Effects of a physical therapy program combined with manual lymphatic drainage on shoulder pain and function, quality of life, lymphedema incidence in breast cancer patients with axillary web syndrome following axillary dissection: A randomized controlled trial. **Detailed Description:** This study's objective is to assess the effectiveness of physical therapy (PT) combined with manual lymphatic drainage (MLD) on shoulder pain and function, lymphedema, visible cords, and quality of life (QOL), compared to physical therapy alone, in subjects with breast cancer and suffering of axillary web syndrome (AWS). ### Conditions Module **Conditions:** - Movement Disorders ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Controlled parallel groups ##### Masking Info **Masking:** DOUBLE **Masking Description:** Double blinded **Who Masked:** - PARTICIPANT - CARE_PROVIDER **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 34 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** group will be prescribed a usual physical therapy program three times a week for four weeks, which will be conducted in the clinic. The program consists of eight sessions comprising warm-up and cool-down, stretching activities, and strengthening exercises, and manual therapy. The program will start with 10-minute warm-up and 10-minute cool-down periods of physical therapy sessions **Intervention Names:** - Other: Physical therapy program **Label:** Physical therapy program **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** physical therapy program three times a week for four weeks, which will be conducted in the clinic. The program consists of eight sessions comprising warm-up and cool-down, stretching activities, and strengthening exercises,And manual lymphatic drainage prescribed 20 minutes of MLD daily. The program will be prescribed five times a week, for four weeks **Intervention Names:** - Other: Physical therapy program with lymphedema drainage **Label:** Physical therapy program with lymphedema drainage **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Physical therapy program **Description:** group will be prescribed a usual physical therapy program three times a week for four weeks, which will be conducted in the clinic. The program consists of eight sessions comprising warm-up and cool-down, stretching activities, and strengthening exercises, and manual therapy. The program will start with 10-minute warm-up and 10-minute cool-down periods of physical therapy sessions **Name:** Physical therapy program **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Physical therapy program with lymphedema drainage **Description:** physical therapy program three times a week for four weeks, which will be conducted in the clinic. The program consists of eight sessions comprising warm-up and cool-down, stretching activities, and strengthening exercises,And manual lymphatic drainage prescribed 20 minutes of MLD daily. The program will be prescribed five times a week, for four weeks **Name:** Physical therapy program with lymphedema drainage **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Pain intensity will be assessed using the NRS (0-10). A score of 0 means there is no pain, while a score of 10 means presence of severe pain. **Measure:** Pain intensity **Time Frame:** 5 weeks **Description:** Assessment of disability will be done using the Arabic Quick-DASH questionnaire which is an 11-item self-report questionnaire, The DASH has five response options for each item from 0=no difficulty to perform or no symptoms to 5=unable to do. A higher score reflects greater disability. **Measure:** Disability **Time Frame:** 5 weeks #### Secondary Outcomes **Description:** The limb girth will be measured using the tape measurement. Upper limb volumes will be calculated from circumference measurements taken at 4-cm intervals from the dorsum of the wrist to the axilla. The diagnostic criterion for lymphedema was ≥3 % volume increase from baseline in the affected upper limb. **Measure:** Limb Girth **Time Frame:** 4 weeks **Description:** lymphedema therapist (PT/CLT) will examine the arm and axilla for any visible or palpable cords. The findings will be either positive for cording or negative. It is a nominal qualitative variable. **Measure:** Cording **Time Frame:** 5 weeks **Description:** Using a hand-held dynamometer, the maximum voluntary isometric contraction of the muscles will be used to assess their strength. **Measure:** Muscular strength **Time Frame:** 5 weeks **Description:** The active ROM (AROM) will be assessed using a goniometer which has been proved to have reliability and concurrent validity for measuring shoulder mobility measurements **Measure:** Range of motion **Time Frame:** 5 weeks **Description:** The EORTC QLQ-C30 is a 30-item questionnaire including measuring Global Health status (2 items), Functional scales (15 items) and Symptoms scales/items (13 items). Items were measured using a 4-point Likert Scale ranging from Not at all (1) to Very much (4) **Measure:** Quality of life for participants **Time Frame:** 5 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * had a breast cancer dissection with lymphadenectomy and/or sentinel lymph node biopsy and a subsequent appearance of AWS (diagnosed by physical examination and also by using the Screening Test AWS (ST-AWS)) \[35\]. * suffering of pain that exceeds 6-8 points (measured by the numeric rating scale (NRS)) in the region of the cording on the upper/lower arm, elbow, and dorsum site, and * have visible or palpable cords in the arm or breast. Exclusion Criteria: * suffering of both acute thrombosis and lymphedema, * suffering of skin issues like infections or musculoskeletal conditions like adhesive capsulitis, rheumatoid arthritis, pectoral muscle tightness, and diseases of the rotator cuff, and/or * having cording that doesn't involve an arm and only affects the chest or side of the thorax. **Maximum Age:** 65 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Ibrahim.alkayshan@gmail.com **Name:** Ibrahim Alkayshan, Bachelorette **Phone:** 0096650127261 **Role:** CONTACT **Contact 2:** **Email:** Alaa.s.baboor@hotmail.com **Name:** Alaa Baboor, Bachelorette **Phone:** 00966596628155 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Taif University **Name:** Hassan Alzahrani, PHD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M12029 - Name: Movement Disorders - Relevance: HIGH - As Found: Movement Disorders - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M29453 - Name: Mastodynia - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009069 - Term: Movement Disorders ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438835 **Brief Title:** Development & Evaluation of Pneumatic Artificial Muscle(PAM) for Patients With Ankle Foot Orthosis(AFO) **Official Title:** Development & Evaluation of Pneumatic Artificial Muscle(PAM) for Patients With Ankle Foot Orthosis(AFO) #### Organization Study ID Info **ID:** MSRSW/Batch-Fall22/703 #### Organization **Class:** OTHER **Full Name:** Superior University ### Status Module #### Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-04-01 **Type:** ACTUAL #### Start Date **Date:** 2023-10-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-05-29 ### 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:** Pneumatic Artificial Muscles (PAMs), inspired by the structure and function of natural muscles, offer a lightweight and adaptable solution compared to traditional rigid Ankle Foot Orthosis(AFOs). **Detailed Description:** The development process involves design optimization to ensure proper, fit, functionality and durability. Researchers utilize advanced materials and manufacturing techniques to create PAMs that mimic the natural movement of the ankle joint while providing sufficient support and flexibility. Evaluation of PAMs involves rigorous testing in both laboratory settings and real world environments. Bio-mechanical analysis assesses the performance of PAMs during various activities such as walking, running and stair negotiation. Critical trails involving patients with AFOs provide valueable feedback on usability, comfort and overall satisfaction. Additionally, long-term studied monitor the durability and reliability of PAMs over extended periods of use. Overall, the development and evaluation of PAMs for patient with AFOs represent a significant advancement in assistive technology. By offering a more natural and adaptive solution for gait assistance, PAMs enhance mobility, independence and quality of life for individuals with mobility impairments. ### Conditions Module **Conditions:** - Orthopedic Disorder ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 4 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Diagnostic Test: PneuFlex AFO Assist **Label:** PneuFlex AFO Assist **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - PneuFlex AFO Assist **Description:** It features a pneumatic artificial muscle designed to enhance ankle foot orthosis functionally for patients with mobility issues. **Name:** PneuFlex AFO Assist **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Functional mobility is a person's physiological ability to move independently and safely in a variety of environments in order to accomplish functional activities or tasks and to participate in the activities of daily living, at home, work and in the community **Measure:** Functional Mobility **Time Frame:** 12 months **Description:** Range of motion means the extent or limit to which a part of the body can be moved around a joint or a fixed point; the totality of movement a joint is capable of doing. Range of motion of a joint is gauged during passive ROM (assisted) PROM or active ROM (independent) AROM. **Measure:** Range of motion (ROM) **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosis of droop foot * Ability to tolerate pneumatic pressure * Sufficient muscle strength activation Exclusion Criteria: * Allergy to materials used in device fabrication * Severe muscle weakness preventing activation * Uncontrolled hypertension, pregnancy. **Maximum Age:** 65 Years **Minimum Age:** 14 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Faisalābad **Country:** Pakistan **Facility:** Al-Ghani rehabilitation centre. Opposite to Misaq-ul-mall **State:** Punjab ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: HIGH - As Found: Orthopedic Disorder ### Condition Browse Module - Meshes - ID: D000009140 - Term: Musculoskeletal Diseases ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438822 **Brief Title:** Cadonilimab Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracil for Advanced Cholangiocarcinoma **Official Title:** Second-line Treatment of PD-1 and CTLA-4 Blockade Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracil for Advanced Cholangiocarcinoma: a Single-arm, Prospective Phase II Trial #### Organization Study ID Info **ID:** 2024（791） #### Organization **Class:** OTHER **Full Name:** West China Hospital ### Status Module #### Completion Date **Date:** 2026-11-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-08-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-28 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** West China Hospital #### Responsible Party **Investigator Affiliation:** West China Hospital **Investigator Full Name:** Dan Cao **Investigator Title:** Chief physician **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study aimed to evaluate the efficacy and safety of the combination of cadonilimab with liposomal irinotecan plus fluorouracil and leucovorin for the treatment of advanced biliary tract cancer. ### Conditions Module **Conditions:** - Cholangiocarcinoma ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 51 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** There will be two cohorts. Cohort 1 includes patients who have failed first-line treatment with gemcitabine-based chemotherapy combined with PD-L1/PD-1 monoclonal antibody immunotherapy. Cohort 2 includes patients who have failed chemotherapy with gemcitabine-based chemotherapy as a first-line treatment and who had not been treated with PD-L1/PD-1 monoclonal antibody immunotherapy. **Intervention Names:** - Combination Product: Cadonilimab Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracil **Label:** Cadonilimab+NIFU regimen **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Cadonilimab+NIFU regimen **Description:** cadonilimab at a dosage of 6 mg/kg on day 1 of each 21-day cycle combined with intravenous liposomal irinotecan at a dosage of 70 mg/m2 for 90 min on day 1 plus leucovorin at a dosage of 400 mg/m2 for 30 min on day 1 and fluorouracil at a dosage of 400 mg/m2 for 46 h every 2 weeks. **Name:** Cadonilimab Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracil **Type:** COMBINATION_PRODUCT ### Outcomes Module #### Primary Outcomes **Description:** The total number of participants in the intention-to-treat (ITT) population who achieve a complete response (CR) or partial response (PR) will be considered valid, and the statistical results were used to calculate the ORR based on imaging (CT/MRI) using the RECIST v1.1 criteria. **Measure:** overall response rate (ORR) **Time Frame:** Up to 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Diagnosed with pathologically confirmed locally advanced unresectable or metastatic adenocarcinoma of the bile ducts, gallbladder, or cholangiocellular carcinoma, with primary tumors located in the intrahepatic bile ducts, hilar bile ducts, distal bile ducts, or gallbladder; 2. Progression after prior gemcitabine-based systemic chemotherapy and refused or were intolerable to initial treatment with gemcitabine-based chemotherapy regimens; 3. At least one measurable objective lesion of the tumor according to the RECIST version 1.1 criteria, which must have a maximum diameter of ≥1 cm for spiral CT or ≥2 cm for plain CT or MRI; and should be performed within 28 days prior to enrollment; 4. Aged 18 to 75 years old; 5. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1; 6. Life expectancy of greater than 3 months; 7. Must be able to participate the study voluntarily and sign the informed consent document; 8. Adequate organ and bone marrow function as below: Absolute neutrophil count ≥1.5\*109/L , platelet count ≥75\*109/L , hemoglobin ≥90g/L; Alanine aminotransferase, and aspartate aminotransferase ≤2.5 × upper limit of normal; Total bilirubin and serum creatinine ≤1.5 × upper limit of normal. Exclusion Criteria: 1. Disease-free survival within 5 years due to other malignancies (except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix); 2. Serious or uncontrolled infectious disease (HIV, HBV DNA \> 500IU/ml); 3. Severe uncontrolled acute infection (infection causing a fever of 38℃ or higher)； 4. Severe hepatic or renal insufficiency; or recent history of myocardial infarction (within 3 months)； 5. Current or past autoimmune disease and susceptibility to its reoccurrence; 6. Serious or uncontrolled pleural effusion or ascites; 7. Subjects with a history of active tuberculosis infection within 1 year prior to the first administration of study drug. If in the judgment of the investigator, subjects with more than 1 year prior to the first administration of study drug were considered suitable for enrollment; Subjects with a long history of chronic diarrhea or the presence of complete intestinal obstruction; 8. Subjects requiring systemic therapy with corticosteroids (\> 10 mg/day prednisone equivalent dose) or other immunosuppressive drugs within 14 days prior to administration of study drug. 9. Combined with other serious medical and surgical conditions that affected organ function; 10. Participated in other clinical trial within 4 weeks; 11. Pregnant or breastfeeding women or subjects of childbearing potential (males or females with less than 1 year of menopause) who were unwilling to use contraception; 12. Subjects with a history of allergic or hypersensitivity reactions to components of the study drug; **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ## 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: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000000970 - Term: Antineoplastic Agents - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000059004 - Term: Topoisomerase I Inhibitors - ID: D000059003 - Term: Topoisomerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000000931 - Term: Antidotes - ID: D000020011 - Term: Protective Agents - ID: D000014803 - Term: Vitamin B Complex - ID: D000014815 - Term: Vitamins - ID: D000018977 - Term: Micronutrients ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: Micro - Name: Micronutrients - Abbrev: Hemat - Name: Hematinics - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M4230 - Name: Antibodies, Monoclonal - Relevance: LOW - As Found: Unknown - ID: M2985 - Name: Gemcitabine - Relevance: LOW - As Found: Unknown - ID: M1671 - Name: Irinotecan - Relevance: HIGH - As Found: Infection - ID: M8600 - Name: Fluorouracil - Relevance: HIGH - As Found: According - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M6191 - Name: Leucovorin - Relevance: HIGH - As Found: Video - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - 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 - ID: M29349 - Name: Topoisomerase I Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4250 - Name: Antidotes - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown - ID: M17558 - Name: Vitamins - 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: M21009 - Name: Micronutrients - Relevance: LOW - As Found: Unknown - ID: M16885 - Name: Trace Elements - 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: D000002955 - Term: Leucovorin - ID: D000005472 - Term: Fluorouracil - ID: D000077146 - Term: Irinotecan ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438809 **Brief Title:** Umbilical-Cord-Derived Mesenchymal Stem Cells Injection for Chronic Radiation Proctitis **Official Title:** Safety and Preliminary Efficacy of Umbilical-Cord-Derived Mesenchymal Stem Cells Injection for Chronic Radiation Proctitis #### Organization Study ID Info **ID:** TH-SC01-RP-I/II-03 #### Organization **Class:** INDUSTRY **Full Name:** Jiangsu Topcel-KH Pharmaceutical Co., Ltd. ### Status Module #### Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Jiangsu Topcel-KH Pharmaceutical Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** A Phase I/II study to evaluate the safety and preliminary efficacy of human umbilical cord-derived mesenchymal stem cell injection for the treatment of chronic radiation proctitis. **Detailed Description:** Radiation therapy is frequently used to treat pelvic cancers such as anal, cervical, prostate, and rectal cancer. While effective in controlling local tumors, it can also cause collateral damage to the gastrointestinal tract. The rectum is particularly vulnerable to radiation damage due to its fixed position in the pelvis. In the acute phase, radiation can lead to proctitis, an inflammatory condition characterized by mucosal ulceration, edema, and loss of microvilli. Patients typically present within three months of radiation therapy with symptoms like diarrhea, urgency, and tenesmus. Chronic radiation proctitis can either follow the acute phase or appear after a symptom-free period, typically 8 to 12 months post-radiation treatment. This chronic condition results from radiation-induced small-vessel injury, causing ischemia, obliterative endarteritis, fibrosis, and neovascularization. Rectal bleeding is a common symptom of chronic radiation proctitis. Clinical studies have demonstrated that mesenchymal stem cell (MSC) treatment offers significant benefits, including anti-inflammatory, immune modulation, and tissue repair effects. Recent research indicates that intralesional injection of MSC is effective in treating radiation proctitis, reducing pain and bleeding without causing severe adverse events. This suggests that MSC treatment could be a promising option for radiation proctitis. This is a phase I/II study designed to evaluate the safety and preliminary efficacy of MSC treatment for radiation proctitis. Patients will be followed up for 24 months after treatment. ### Conditions Module **Conditions:** - Chronic Radiation Proctitis ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 24 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All patients will receive a single injection of umbilical cord-derived mesenchymal stem cells (120 million cells), and their therapeutic response will be monitored over a period of 24 months. **Intervention Names:** - Biological: Mesenchymal Stem Cells (MSCs) **Label:** Open label single arm study **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Open label single arm study **Description:** MSC suspension single does injection. **Name:** Mesenchymal Stem Cells (MSCs) **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Adverse events are any unexpected medical occurrences in a participant that may not be directly caused by the trial intervention. Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 is a grading scale which can be utilized for adverse event (AE) reporting. It ranges from grade 1 (mild) to grade 5 (death related to AE) , and higher grade means the AE is more severe. **Measure:** The severity of adverse events after administration as assessed by CTCAE v5.0. **Time Frame:** 28 days (1 month) **Description:** Adverse events are any unexpected medical occurrences in a participant that may not be directly caused by the trial intervention. **Measure:** The incidence of adverse events after administration. **Time Frame:** 28 days (1 month) #### Secondary Outcomes **Description:** Adverse events are any unexpected medical occurrences in a participant that may not be directly caused by the trial intervention. Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 is a grading scale which can be utilized for adverse event (AE) reporting. It ranges from grade 1 (mild) to grade 5 (death related to AE) , and higher grade means the AE is more severe. **Measure:** The severity of adverse events after administration as assessed by CTCAE v5.0. **Time Frame:** 112 days (4 month) **Description:** Adverse events are any unexpected medical occurrences in a participant that may not be directly caused by the trial intervention. **Measure:** The incidence of adverse events after administration. **Time Frame:** 112 days (4 month) **Description:** The recurrence means that subjects who were previously cured or relieved are diagnosed again by the investigator, clinically, as having chronic radiation proctitis. **Measure:** The recurrence of chronic radiation proctitis symptoms after administration. **Time Frame:** Day 112 (month 4) **Description:** The deterioration means that the symptoms of chronic radiation proctitis have worsened compared to baseline. **Measure:** The deterioration of chronic radiation proctitis symptoms after administration. **Time Frame:** Day 112 (month 4) **Description:** The Late Effects Normal Tissue/Subjective Objective Management Analytic (LENT/SOMA) is used for grading radiation therapy (RT)-induced side effects. It is graded on a 4-point scale ranging from occasional (score of 1) to refractory (score of 4), with a higher score indicating more severe disease. No improvement means no improvement of the score comparing to the baseline level. **Measure:** No improvement of chronic radiation proctitis symptoms after administration as assessed by LENT-SOMA score. **Time Frame:** Day 112 (month 4) **Description:** The Vienna Rectoscopy Score (VRS) is a feasible and effective tool for detecting and classifying pathological changes in the rectal mucosa after radiotherapy (RT). It is graded on a 5-point scale, ranging from 0 to 5, with a higher score indicating more severe disease. No improvement means that the score does not improve compared to the baseline level. **Measure:** No improvement of chronic radiation proctitis symptoms after administration as assessed by VRS. **Time Frame:** Day 112 (month 4) **Description:** A specific scoring system that assesses the intensity of morphological features has been developed. The total score ranging from 0 to 10 , and a higher score indicates more severe disease. No improvement means that the score does not improve compared to the baseline level. **Measure:** No improvement of chronic radiation proctitis symptoms after administration as assessed by a semi-quantitative scoring system for radiotherapy-induced rectal pathological damage. **Time Frame:** Day 112 (month 4) **Description:** The rectal telangiectasia density (RTD) grading scale ranges from 0 to 3, and a higher score indicates the disease is more severe. No improvement means that the score does not improve compared to the baseline level. **Measure:** No improvement of chronic radiation proctitis symptoms after administration as assessed by a RTD grading scale. **Time Frame:** Day 112 (month 4) **Description:** The Visual Analogue Scale (VAS) is commonly used to assess the intensity of a patient's pain, ranging from none to extreme. It is graded on an 11-point scale,ranging from 0 to 10,with higher scores indicating more severe pain. No improvement means that the score does not improve compared to the baseline level. **Measure:** No improvement of chronic radiation proctitis symptoms after administration as assessed by VAS score. **Time Frame:** Day 112 (month 4) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Fully understand and sign the informed consent form; 2. Age ≥18 years and \<80 years; 3. Good physical condition (WHO performance status score 0-1); 4. Pathologically diagnosed with pelvic malignant tumors and received radiotherapy; 5. Diagnosed with chronic radiation proctitis after at least 6 months of endoscopic examination following the completion of radiotherapy and ineffective conventional treatment; 6. Screening period LENT-SOMA score ≥1; 7. Subjects and their spouses or partners have no plans for conception from screening to 6 months after the end of the trial, no plans for sperm or egg donation, and agree to use effective non-pharmacological contraceptive measures during the trial. Exclusion Criteria: 1. Patients with severe liver or kidney dysfunction during the screening period; 2. Patients with severe congestive heart failure or coronary artery disease during the screening period; 3. Patients with allergic constitution or severe systemic immune diseases; 4. Patients with active gastrointestinal bleeding or acute intestinal obstruction during the screening period; 5. Pregnant patients; 6. Patients with rectal stenosis or fistula formation requiring surgical treatment that limits endoscopic therapy; 7. Patients with a screening period LENT-SOMA score of 4; 8. Patients with tumor recurrence or metastasis; 9. Patients currently participating in other clinical trials at the time of screening or who have not been out of another clinical trial for less than 1 month; 10. Other situations deemed unsuitable for inclusion in this study by the investigator. **Maximum Age:** 79 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** zhsl@vip.163.com **Name:** Zhaoshen Li, MD **Phone:** 021-81873241 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005759 - Term: Gastroenteritis - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000012002 - Term: Rectal Diseases - ID: D000007410 - Term: Intestinal 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: M14222 - Name: Proctitis - Relevance: HIGH - As Found: Proctitis - 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: M14844 - Name: Rectal Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011349 - Term: Proctitis ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438796 **Brief Title:** Blinatumomab Maintenance After Allo-HSCT **Official Title:** Efficacy and Safety of Blinatumomab Maintenanceafter Allogeneic Hematopoietic Stem Cell Transplantation for High-risk Acute B-lymphoblastic Leukemia: a Multicenter, Open-label, Randomized Controlled Study #### Organization Study ID Info **ID:** TROPHY-ALL01 #### Organization **Class:** OTHER **Full Name:** Ruijin Hospital ### Status Module #### Completion Date **Date:** 2028-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-30 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ruijin Hospital #### Responsible Party **Investigator Affiliation:** Ruijin Hospital **Investigator Full Name:** Hu Xiaoxia **Investigator Title:** Principal Investigator **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:** To evaluate the safety and efficacy of Blinatumomab maintenance after allogeneic hematopoietic stem cell transplantation for high-risk acute B-lymphoblastic leukemia. **Detailed Description:** Blinatumomab is a novel immunological antibody based on BiTE. CD19 is a surface antigen expressed throughout the development of B lymphocytes, making it an ideal target for immunotherapy. Blinatumomab was approved by the FDA for the treatment of adults with relapsed/refractory cancers. Open-label, single-arm, multicenter phase II clinical study (BLAST study) , enrolling 116 adult patients with precursor B-ALL in complete hematologic remission after at least 3 doses of intense chemotherapy but persistently positive for Measurable Residual Disease (MRD) (MRD ≥10-3 ), which is the first ALL international multicenter clinical trial. In August 2022, China's National Medicines and Pharmaceutical Administration (NMPA) Approved Blinatumomab for the treatment of relapsed/refractory precursor B-cell ALL in adults. Blinatumomab is mostly used for preemptive therapy after post-transplant MRD conversion, and fewer prospective studies have been conducted in the area of maintenance therapy. A prospective single-arm clinical study (NCT02807883) with Blinatumomab as maintenance therapy (up to 4 cycles) after allogeneic transplantation, concluded by MD Anderson in August 2021, had the primary endpoints of safety (acute graft-versus-host disease \[aGVHD\] and non-relapse mortality \[NRM\]) and the secondary endpoints of efficacy (PFS, OS, etc.), a total of 23 patients were enrolled in patients who received at least 1 cycle of Blinatumomab, the interval between transplantation and the first cycle of Blinatumomab use was 78 days (44-105), 57% of the patients completed 4 cycles of treatment, the median follow-up was 14.3 months, the 1-year NRM was 0%, the incidence of grade 3-4 aGVHD was 5%, the 1-year OS was 85%, and the 1-year PFS was 71%. There was a trend toward benefit in PFS and OS curves between the two groups. Although this study is an exploratory study, data from applied studies in the post-transplantation maintenance phase suggest that this immunotherapy may be termed as a new, better and safer option. Therefore, the investigators conducted a multicenter, randomized, controlled study based on retrospective research to further explore and validate the safety and efficacy of Blinatumomab as a maintenance therapy after high-risk B-ALL allogeneic transplantation. ### Conditions Module **Conditions:** - High Risk Acute Lymphoblastic Leukemia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 59 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Blinatumomab group (Blinatumomab): 9 μg/d intravenously over 24 hours until the end of d14 days of dosing. Repeat every 3 months for a total of 4 courses. (Basis for Dose Selection: The recommended dose of blinatumomab for MRD-negative patients is 9ug/d) **Intervention Names:** - Drug: Blinatumomab **Label:** Blinatumomab group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Maintenance therapy in the control group was based on the routine maintenance therapy in each center (including but not limited to decitabine, sorafenib, prophylactic DLI, except for all types of CD19 mono- and dual-antibodies and CD22-ADC drugs). **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Blinatumomab group **Description:** Maintenance therapy with Blinatumomab initiation: 90 days to 120 days post-transplantation **Name:** Blinatumomab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** 2-year Event-free survival **Time Frame:** through study completion, an average of 2 year #### Secondary Outcomes **Measure:** 2-year relapse rate **Time Frame:** through study completion, an average of 2 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age 16-65 years 2. Diagnosis with acute B-lymphoblastic leukemia (B-ALL) expressed CD19 3. High-risk group B-ALL 4. Have suitable hematopoietic stem cell donors 5. No dysfunction of vital organs Exclusion Criteria: 1. CR/MRD negative before blinatumomab maintenance 2. Active hepatitis B 3. HIV-infected 4. Active infections; acute and chronic GVHD requiring systemic immunosuppressive therapy; 5. severe impairment of vital organ function 6. Those judged by the investigator to be unsuitable for participation in this trial. **Maximum Age:** 65 Years **Minimum Age:** 16 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000006402 - Term: Hematologic Diseases - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000008206 - Term: Lymphatic Diseases - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10945 - Name: Leukemia - Relevance: HIGH - As Found: Leukemia - ID: M27585 - Name: Precursor Cell Lymphoblastic Leukemia-Lymphoma - Relevance: HIGH - As Found: Lymphoblastic Leukemia - ID: M10951 - Name: Leukemia, Lymphoid - Relevance: HIGH - As Found: Lymphoblastic Leukemia - ID: M11220 - Name: Lymphoma - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T175 - Name: Acute Lymphoblastic Leukemia - Relevance: HIGH - As Found: Acute Lymphoblastic Leukemia - ID: T3533 - Name: Lymphoblastic Lymphoma - Relevance: HIGH - As Found: Lymphoblastic Leukemia - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T3543 - Name: Lymphosarcoma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007938 - Term: Leukemia - ID: D000054198 - Term: Precursor Cell Lymphoblastic Leukemia-Lymphoma - ID: D000007945 - Term: Leukemia, Lymphoid ### Intervention Browse Module - Ancestors - ID: 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: M1697 - Name: Decitabine - Relevance: LOW - As Found: Unknown - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M287547 - Name: Blinatumomab - Relevance: HIGH - As Found: Coffee - ID: M1680 - Name: Sorafenib - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000510808 - Term: Blinatumomab ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438783 **Brief Title:** TQB2928 Injection Combined Anlotinib Hydrochloride Capsule in Recurrent/Metastatic Osteosarcoma and Other Solid Tumors **Official Title:** A Multicenter, Open-label, Multi-cohort Phase Ib Trial Evaluating the Efficacy and Safety of TQB2928 Injection Combined With Anlotinib Hydrochloride Capsule in Relapsed/Metastatic Osteosarcoma and Other Relapsed/Metastatic Solid Tumors #### Organization Study ID Info **ID:** TQB2928-ALTN-Ib-01 #### Organization **Class:** INDUSTRY **Full Name:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ### Status Module #### Completion Date **Date:** 2026-02 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-30 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-15 **Type:** ACTUAL **Status Verified Date:** 2023-09 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is a multicenter, open-label, multi-cohort Phase Ib trial to evaluate the efficacy and safety of TQB2928 injection combined with anlotinib hydrochloride capsule in patients with relapsed/metastatic osteosarcoma and other relapsed/metastatic solid tumors. ### Conditions Module **Conditions:** - Osteosarcoma - Other Solid Tumors ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 43 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 21 days as a treatment cycle. **Intervention Names:** - Drug: 1200mg of TQB2928 injection+Anlotinib **Label:** 1200mg of TQB2928 injection +Anlotinib **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 21 days as a treatment cycle. **Intervention Names:** - Drug: 1800mg of TQB2928 injection+Anlotinib **Label:** 1800mg of TQB2928 injection+Anlotinib **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 1200mg of TQB2928 injection +Anlotinib **Description:** TQB2928 is a novel humanized immunoglobulin G4 (IgG4) subtype monoclonal antibody targeting Cluster of Differentiation 47 (CD47). **Name:** 1200mg of TQB2928 injection+Anlotinib **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - 1800mg of TQB2928 injection+Anlotinib **Description:** TQB2928 is a novel humanized igG4 subtype monoclonal antibody targeting CD47. **Name:** 1800mg of TQB2928 injection+Anlotinib **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Cohort 1: Kaplan-Meier method was used to plot the survival curve, in which the cumulative survival rate and 95% confidence interval corresponding to the progression-free survival time of 6 months were obtained. **Measure:** Cohort 1: Progression-Free Survival (PFS) of 6 months **Time Frame:** Up to 6 months **Description:** Cohort 2: The percentage of subjects with complete (CR) or partial response (PR) as determined by the investigator according to the RECIST 1.1 criteria. **Measure:** Cohort 2: Overall response rate (ORR) **Time Frame:** Up to 6 months #### Secondary Outcomes **Description:** Cohort 1: Survival curve was plotted using Kaplan-Meier method. In the curve, the corresponding cumulative survival rate and 95% confidence interval for progression-free survival of 4 months were obtained. **Measure:** Cohort 1: Progression-Free Survival (PFS) of 4 months **Time Frame:** Up to 4 months **Description:** Cohort 1: The percentage of subjects with complete (CR) or partial response (PR) as determined by the investigator according to the RECIST 1.1 criteria. **Measure:** Cohort 1: Overall response rate (ORR) **Time Frame:** Baseline up to 96 weeks **Description:** Cohort 2: Kaplan-Meier method was used to plot the survival curve with the corresponding cumulative survival rate and 95% confidence interval (95% CI) when the progression-free survival time was 6 months. The overall population and 2 dose groups were counted separately (including participants in the safe introduction period and the extended period). **Measure:** Cohort 2: Progression-Free Survival (PFS) of 6 months **Time Frame:** Up to 6 months **Description:** The time between medication or random initiation and objective progression of disease or death from any cause, whichever comes first. **Measure:** Progression-Free Survival (PFS) of Cohort 1 and Cohort 2 **Time Frame:** Up to 96 weeks **Description:** The percentage of subjects with complete response (CR), partial response (PR), or stable disease (SD) for 6 weeks or more as determined by the investigator based on RECIST 1.1. **Measure:** Disease control rate (DCR) of Cohort 1 and Cohort 2 **Time Frame:** Up to 6 weeks **Description:** For subjects whose optimal response was complete response (CR) or partial response (PR), defined as from the date when tumor response was first documented to the date when disease progression was first documented or the date of death from any cause, whichever came first. **Measure:** Duration of response(DOR) of Cohort 1 and Cohort 2 **Time Frame:** Baseline up to 96 weeks **Description:** From randomization to the time of death from any cause. **Measure:** Overall survival (OS) of Cohort 1 and Cohort 2 **Time Frame:** Baseline up to 96 weeks **Description:** Incidence and severity of adverse events (AES) and serious adverse events (SAEs), abnormal laboratory test indicators and treatment-related adverse events (TEAEs). **Measure:** Adverse event rate of Cohort 1 and Cohort 2 **Time Frame:** Baseline up to 96 weeks **Description:** The positive rates of immunogenicity (ADA and NAb) in subjects were summarized and descriptive statistical analysis was performed. **Measure:** Incidence of Anti-drug antibody (ADA )and Neutralizing Antibody( NAb ) **Time Frame:** 30 minutes before administration on day 1 of cycles 1, 2, 4 and 8 (each cycle is 21 days), day 90 after the last administration (±7 days) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Pathological diagnosis of high-grade osteosarcoma(cohort I),dedifferentiated liposarcoma or polytypic liposarcoma(cohort II),unsuitable for local treatment; * The requirements for front-line treatment received by subjects are as follows: 1. Subjects with osteosarcoma have failed at least first-line chemotherapy and are not suitable for re-receiving first-line chemotherapy ,or progression within 6 months of the end of first-line therapy; 2. Subjects with dedifferentiated liposarcoma or polytype liposarcoma who have received at least first-line chemotherapy failure for recurrent/metastatic sites or relapse during postoperative adjuvant chemotherapy or within 6 months after treatment(considered first-line treatment failure). Exclusion Criteria: * History of hemolytic anemia from any cause (including Evans syndrome) within 3 months prior to first dosing; * Subjects with osteosarcoma or dedifferentiated liposarcoma/polytype liposarcoma who have previously used antiangiogenic tyrosine kinase inhibitors (TKI) or bevacizumab or its biosimilar, such as anlotinib, apatinib, lenvatinib, sorafenib, sunitinib, regorafenib, fruquintinib; * Previous antibody or fusion protein or small molecule drug targeting CD47 or Signal-regulatory protein α (SIRRP-α). **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** xie.lu@hotmail.com **Name:** Lu Xie, Doctor **Phone:** 13401044719 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** niuxiaohuiJST@163.com - **Name:** Xiaohui Niu, Doctor - **Phone:** 13801132522 - **Role:** CONTACT **Country:** China **Facility:** Beijing jishuitan hospital **State:** Beijing **Status:** NOT_YET_RECRUITING **Zip:** 100035 **Location 2:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** xie.lu@hotmail.com - **Name:** Lu Xie - **Phone:** 13401044719 - **Role:** CONTACT **Country:** China **Facility:** Pekjing university people's hospital **State:** Beijing **Status:** RECRUITING **Zip:** 100044 **Location 3:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** silu15_silu@126.com - **Name:** Lu Si, Doctor - **Phone:** 13810700214 - **Role:** CONTACT **Country:** China **Facility:** Beijing cancer hospital **State:** Beijing **Status:** NOT_YET_RECRUITING **Zip:** 100142 **Location 4:** **City:** Changsha **Contacts:** ***Contact 1:*** - **Email:** lixianan2001@163.com - **Name:** Xianan Li, Doctor - **Phone:** 18874933879 - **Role:** CONTACT **Country:** China **Facility:** Hunan cancer hospital **State:** Hunan **Status:** NOT_YET_RECRUITING **Zip:** 410031 **Location 5:** **City:** Tianjin **Contacts:** ***Contact 1:*** - **Email:** wgwhrb@163.com - **Name:** Guowen Wang, Doctor - **Phone:** 18622221109 - **Role:** CONTACT **Country:** China **Facility:** Tianjin medical university cancer institute&hospital **State:** Tianjin **Status:** NOT_YET_RECRUITING **Zip:** 300181 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009369 - Term: Neoplasms - ID: D000018213 - Term: Neoplasms, Bone Tissue - ID: D000009372 - Term: Neoplasms, Connective Tissue - ID: D000018204 - Term: Neoplasms, Connective and Soft Tissue - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000012509 - Term: Sarcoma ### 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 - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M15334 - Name: Osteosarcoma - Relevance: HIGH - As Found: Osteosarcoma - ID: M20359 - Name: Neoplasms, Bone Tissue - Relevance: LOW - As Found: Unknown - ID: M12317 - Name: Neoplasms, Connective Tissue - Relevance: LOW - As Found: Unknown - ID: M20350 - Name: Neoplasms, Connective and Soft Tissue - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M15327 - Name: Sarcoma - Relevance: LOW - As Found: Unknown - ID: T4340 - Name: Osteosarcoma - Relevance: HIGH - As Found: Osteosarcoma - ID: T5284 - Name: Soft Tissue Sarcoma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012516 - Term: Osteosarcoma ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4230 - Name: Antibodies, Monoclonal - Relevance: LOW - As Found: Unknown - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M10122 - Name: Immunoglobulin G - Relevance: LOW - As Found: Unknown - ID: M19117 - Name: Immunoglobulins, Intravenous - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438770 **Brief Title:** Prediction of Gait After Stroke; an External Validation **Official Title:** Predicting Independent Gait After Stroke: External Validation of a Multivariable Prediction Model #### Organization Study ID Info **ID:** 2020-01966 #### Organization **Class:** OTHER **Full Name:** Kantonsspital Winterthur KSW ### Status Module #### Completion Date **Date:** 2023-09-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-09-15 **Type:** ACTUAL #### Start Date **Date:** 2020-07-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Kantonsspital Winterthur KSW #### Responsible Party **Investigator Affiliation:** Kantonsspital Winterthur KSW **Investigator Full Name:** Martina Betschart **Investigator Title:** Dr. **Type:** PRINCIPAL_INVESTIGATOR ### Description Module **Brief Summary:** The aim of this observational study is to perform a temporal and geographical external validation of the EPOS (Early Prediction of Outcome after Stroke) model for the prediction of independent gait after stroke. The EPOS model measures the early presence of leg strength on the affected side and sitting ability to predict recovery of independent walking six months after stroke. Compared to the EPOS model development study, the prediction time point of independent gait in this study will be three months rather than six months post-stroke and the patients will be more heterogeneous. Due to the differences in the new cohort, it is expected that the performance of the models will be lower than in the development cohort, but still be adequate. **Detailed Description:** Worldwide, stroke is the second leading cause of death and is also the third leading cause of death and disability combined. According to the Global Burden of Disease, Injuries, and Risk Factors Study (GBD) by the Collaborator Network on the topic of stroke, the absolute number of incidence strokes and their deaths have steadily increased in recent years. The most important risk factors include high blood pressure, a high body-mass index, high plasma glucose, fine dust pollution and smoking. In Switzerland, an average of 20'423 people suffered a stroke per year between 2016 and 2020. Due to the growth and ageing of the population, the number of hospitalizations due to cardiovascular diseases is increasing, but deaths have decreased over time. According to a recent study, 75% of stroke survivors are able to walk independently after three months. On average, independent walking is achieved six days post-stroke whereby stroke severity is most strongly associated with recovery of gait. In recent years, a large number of studies have been published showing that prognosis is of growing interest in stroke rehabilitation. Medical prognostic models are used to inform patients and their families about the course of their disease and to plan possible treatments. Early prognosis of recovery after stroke enables early discharge planning and efficient use of health care resources. In addition, therapy goals can be realistically formulated and thus recommendations for care or adaptations of the home environment can be made. Currently, prognostic models are rarely used in clinical practice. This is partly because most of the models have not been externally validated, which is a prerequisite for implementation in practice. External validation involves using new data from a similar population to investigate the generalizability of the model. In summary, a good and useful prognostic model should be accurate, generalizable and ideally clinically effective. A narrative review described six prognostic models for independent gait after stroke. Only three of these models measure predictor and outcome variables at a specifically defined time point: the Australian model, the TWIST model and the EPOS model. The Australian model and the TWIST model have been updated but not externally validated and the EPOS model has been externally validated once. According to the review above, the EPOS model seems to be a promising model for predicting independent gait after a stroke. This is due to the early and fixed time point of simple and fast clinical tests as well as the prognosis time point of six months. The EPOS model shows that early presence of lower limb strength and sitting ability can predict recovery of independent walking six months after stroke. Predictive variables were measured using the Trunk Control Test with the item "sitting balance" (TCT-s) and the Motricity Index leg score (MI leg). The dependent outcome variable was the Functional Ambulation Categories (FAC). In the external validation, the dependent outcome variable FAC was measured after three months. The results show good performance of the model from the third day onwards for predicting independent gait three months after stroke. In summary, these findings raise the question of whether the use of the EPOS model in post-stroke patients within the first 72 hours is accurate and generalizable for predicting independent walking three months after stroke. Although this first external validation shows promising results, further external validation studies need to be undertaken before the model can be applied in clinical practice. The aim of this study is to perform a temporal and geographical external validation of the EPOS prediction model for independent gait after stroke. Compared to the development study, this study will be conducted in Switzerland and the prediction of independent gait will be based on the time point of three months rather than six months post-stroke. In addition, all post-stroke patients will be included, regardless of the type of stroke, the affected circulation or positive stroke history. Furthermore, patients with pre-existing comorbidities are also being considered, as long as they were ambulatory before the stroke. ### Conditions Module **Conditions:** - Stroke **Keywords:** - prediction model - external validation ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 136 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Other Outcomes **Description:** trunk movement and control **Measure:** Trunk Control Test (0-100 points, higher scores being better) **Time Frame:** within 72 hours poststroke **Description:** lower extremity limb strength **Measure:** Motricity Index - lower extremity subscale (0-100 points, higher scores being better) **Time Frame:** within 72 hours poststroke #### Primary Outcomes **Description:** functional gait **Measure:** Functional Ambulation Categories (0-5 points, higher scores being better) **Time Frame:** 3 months poststroke ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. aged 18 years or older 2. having suffered an ischemic or hemorrhagic stroke, confirmed by computerized tomography and/ or magnetic resonance imaging 3. being unable to walk independently (FAC \< 4) within 72 hours 4. giving written informed consent to participate Exclusion Criteria: 1. not able to walk independently before hospital admission (FAC \< 4) 2. clinically significant comorbidities that prevent walking ability 3. deficits in cognition or communication, so consent cannot be given for study participation **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** admitted to hospital with an acute stroke ### Contacts Locations Module #### Locations **Location 1:** **City:** Winterthur **Country:** Switzerland **Facility:** Kantonsspital Winterthur **State:** Zürich **Zip:** 8401 ### References Module #### References **Citation:** GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3. **PMID:** 34487721 **Citation:** Kennedy C, Bernhardt J, Churilov L, Collier JM, Ellery F, Rethnam V, Carvalho LB, Donnan GA, Hayward KS. Factors associated with time to independent walking recovery post-stroke. J Neurol Neurosurg Psychiatry. 2021 Jul;92(7):702-708. doi: 10.1136/jnnp-2020-325125. Epub 2021 Mar 17. **PMID:** 33737383 **Citation:** Ramspek CL, Jager KJ, Dekker FW, Zoccali C, van Diepen M. External validation of prognostic models: what, why, how, when and where? Clin Kidney J. 2020 Nov 24;14(1):49-58. doi: 10.1093/ckj/sfaa188. eCollection 2021 Jan. **PMID:** 33564405 **Citation:** Moons KG, Royston P, Vergouwe Y, Grobbee DE, Altman DG. Prognosis and prognostic research: what, why, and how? BMJ. 2009 Feb 23;338:b375. doi: 10.1136/bmj.b375. No abstract available. **PMID:** 19237405 **Citation:** Kwah LK, Herbert RD. Prediction of Walking and Arm Recovery after Stroke: A Critical Review. Brain Sci. 2016 Nov 2;6(4):53. doi: 10.3390/brainsci6040053. **PMID:** 27827835 **Citation:** Altman DG, Vergouwe Y, Royston P, Moons KG. Prognosis and prognostic research: validating a prognostic model. BMJ. 2009 May 28;338:b605. doi: 10.1136/bmj.b605. No abstract available. **PMID:** 19477892 **Citation:** Langerak AJ, McCambridge AB, Stubbs PW, Fabricius J, Rogers K, Quel de Oliveira C, Nielsen JF, Verhagen AP. Externally validated model predicting gait independence after stroke showed fair performance and improved after updating. J Clin Epidemiol. 2021 Sep;137:73-82. doi: 10.1016/j.jclinepi.2021.03.022. Epub 2021 Mar 31. **PMID:** 33812010 **Citation:** Kwah LK, Harvey LA, Diong J, Herbert RD. Models containing age and NIHSS predict recovery of ambulation and upper limb function six months after stroke: an observational study. J Physiother. 2013 Sep;59(3):189-97. doi: 10.1016/S1836-9553(13)70183-8. Erratum In: J Physiother. 2013 Dec;59(4):218. **PMID:** 23896334 **Citation:** Veerbeek JM, Van Wegen EE, Harmeling-Van der Wel BC, Kwakkel G; EPOS Investigators. Is accurate prediction of gait in nonambulatory stroke patients possible within 72 hours poststroke? The EPOS study. Neurorehabil Neural Repair. 2011 Mar-Apr;25(3):268-74. doi: 10.1177/1545968310384271. Epub 2010 Dec 26. **PMID:** 21186329 **Citation:** Stinear CM, Smith MC, Byblow WD. Prediction Tools for Stroke Rehabilitation. Stroke. 2019 Nov;50(11):3314-3322. doi: 10.1161/STROKEAHA.119.025696. Epub 2019 Oct 15. No abstract available. **PMID:** 31610763 **Citation:** Smith MC, Barber AP, Scrivener BJ, Stinear CM. The TWIST Tool Predicts When Patients Will Recover Independent Walking After Stroke: An Observational Study. Neurorehabil Neural Repair. 2022 Jul;36(7):461-471. doi: 10.1177/15459683221085287. Epub 2022 May 18. **PMID:** 35586876 **Citation:** Veerbeek JM, Pohl J, Held JPO, Luft AR. External Validation of the Early Prediction of Functional Outcome After Stroke Prediction Model for Independent Gait at 3 Months After Stroke. Front Neurol. 2022 May 2;13:797791. doi: 10.3389/fneur.2022.797791. eCollection 2022. **PMID:** 35585839 **Citation:** Smith MC, Barber PA, Stinear CM. The TWIST Algorithm Predicts Time to Walking Independently After Stroke. Neurorehabil Neural Repair. 2017 Oct-Nov;31(10-11):955-964. doi: 10.1177/1545968317736820. Epub 2017 Nov 1. **PMID:** 29090654 #### See Also Links **Label:** Schweizerisches Gesundheitsobservatorium **URL:** https://ind.obsan.admin.ch/ **Label:** Bundesamt für Statistik **URL:** https://www.bfs.admin.ch/bfs/de/home/statistiken/gesundheit/gesundheitszustand/krankheiten/herz-kreislauf-erkrankungen.html ## 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:** NCT06438757 **Brief Title:** Trial of JYB1904 in Allergic Asthma **Official Title:** Phase IIa Trial to Evaluate the Pharmacokinetic/Pharmacodynamic Characteristics and Safety of JYB1904 in Patients With Allergic Asthma #### Organization Study ID Info **ID:** JYB1904-201 #### Organization **Class:** INDUSTRY **Full Name:** Jemincare ### 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:** 2024-06-02 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-10-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-21 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Jemincare #### 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 phase IIa trial is meant to evaluate the pharmacokinetics, pharmacodynamics and safety of JYB1904 in patients with allergic asthma. ### Conditions Module **Conditions:** - Allergic Asthma ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: JYB1904 **Label:** JYB1904: Dose-1 **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: JYB1904 **Label:** JYB1904: Dose-2 **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Drug: JYB1904 **Label:** JYB1904: Dose-3 **Type:** EXPERIMENTAL #### Arm Group 4 **Intervention Names:** - Drug: Omalizumab **Label:** Omalizumab **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - JYB1904: Dose-1 - JYB1904: Dose-2 - JYB1904: Dose-3 **Description:** Participants will receive JYB1904 every 8 weeks for 24 weeks. **Name:** JYB1904 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Omalizumab **Description:** Participants will receive Omalizumab every 2/4 weeks for 24 weeks. **Name:** Omalizumab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Serum concentrations of JYB1904, assessed by pre-specified methods **Measure:** Serum concentrations of JYB1904 **Time Frame:** Baseline through 337 days post-dose **Description:** Serum concentrations of IgE, assessed by pre-specified methods **Measure:** Serum concentrations of IgE **Time Frame:** Baseline through 337 days post-dose **Description:** Incidence and features of AEs assessed by CTCAE v5.0, and related safety parameters analysis **Measure:** Adverse Events(AEs) **Time Frame:** Baseline through 337 days post-dose #### Secondary Outcomes **Description:** Times of protocol-defined asthma exacerbations during the 24-week treatment period **Measure:** Times of protocol-defined asthma exacerbations during the 24-week treatment period **Time Frame:** Baseline through 168 days post-dose **Description:** forced expiratory volume in one second (FEV1) **Measure:** Change in spirometry measures of forced expiratory volume in one second (FEV1) in 24 weeks **Time Frame:** Baseline through 24 weeks post-dose **Description:** Serum ADA assessed by pre-specified methods, and related immunogenic features analysis **Measure:** Serum concentrations of anti-drug antibody (ADA) **Time Frame:** Baseline through 337 days post-dose ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Able to provide written informed consent voluntarily; * Aged 18-75 years, weight ≥ 40 kg, male or female; * Diagnosed Allergic asthma. Exclusion Criteria: * Prior exposure to anti-IgE therapy within 1 year; * Allergic to anti-IgE biologics; * Current smokers, or quit smoking within 1 year; * Combined with other non-allergic diseases that cause IgE elevation； * History of malignancy, autoimmune diseases, Immune complex mediated diseases, Hypereosinophilic syndrome; * Other conditions unsuitable for the trial judged by the investigator. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** wangguorui@jemincare.com **Name:** Guorui Wang **Phone:** +8618115772113 **Role:** CONTACT #### Locations **Location 1:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Email:** 13482345145@163.com - **Name:** Min Zhang - **Phone:** +8613482345145 - **Role:** CONTACT ***Contact 2:*** - **Email:** 13701756821@163.com - **Name:** Xin Zhou - **Phone:** +8613701756821 - **Role:** CONTACT **Country:** China **Facility:** Shanghai General Hospital **State:** Shanghai **Zip:** 201203 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001982 - Term: Bronchial Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000008171 - Term: Lung Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4556 - Name: Asthma - Relevance: HIGH - As Found: Asthma - ID: M5258 - Name: Bronchial Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001249 - Term: Asthma ### Intervention Browse Module - Ancestors - ID: D000018926 - Term: Anti-Allergic Agents - ID: D000018927 - Term: Anti-Asthmatic Agents - ID: D000019141 - Term: Respiratory System Agents ### Intervention Browse Module - Browse Branches - Abbrev: AAll - Name: Anti-Allergic Agents - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M413 - Name: Omalizumab - Relevance: HIGH - As Found: Tea - ID: M20962 - Name: Anti-Allergic Agents - Relevance: LOW - As Found: Unknown - ID: M20963 - Name: Anti-Asthmatic Agents - Relevance: LOW - As Found: Unknown - ID: M21137 - Name: Respiratory System Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000069444 - Term: Omalizumab ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438744 **Brief Title:** The Role of Thread Embedding Acupuncture for Pain and Quality of Life in Endometriosis Patients **Official Title:** The Role of Thread Embedding Acupuncture for Pain and Quality of Life in Endometriosis Patients #### Organization Study ID Info **ID:** 23-10-1610 #### Organization **Class:** OTHER **Full Name:** Indonesia University ### Status Module #### Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-11 **Type:** ESTIMATED #### Start Date **Date:** 2023-12-18 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Indonesia University #### Responsible Party **Investigator Affiliation:** Indonesia University **Investigator Full Name:** Marshellia Setiawan **Investigator Title:** Medical Doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Endometriosis is a common gynecological problem, with pain as the main problem. Pain can be felt for years, in high intensity, continuous, unpredictable, and disrupts the patient's daily life, thereby reducing the quality of life. Dienogest is a progestin-derived drug, the first line therapy for endometriosis pain. Other therapy options include hormonal, non-hormonal therapy, and surgery, but they have a high risk of side effects and recurrence. In cases of endometriosis, acupuncture has an analgesic effect, modulates hormones and neurotransmitters, strengthens immune cells, and reduces inflammation, therefore improves quality of life. However, the effectiveness of thread embedding acupuncture for endometriosis pain is still rarely published. This research was conducted to determine the effectiveness of thread embedding acupuncture for pain and quality of life in endometriosis patients. **Detailed Description:** This study is a one-group pretest-posttest clinical trial. Research subjects will receive a one-time thread embedding acupuncture (TEA) combined with dienogest as standard therapy for 8 weeks. The outcomes assessed will be pain intensity (NRS score) and quality of life score (Endometriosis Health Profile-30 core score) 4 and 8 weeks after receiving TEA combined with standard therapy (posttest), compared with standard therapy alone (pretest). ### Conditions Module **Conditions:** - Endometriosis-related Pain **Keywords:** - endometriosis - pain - ehp30 - acupuncture - thread embedding acupuncture ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** One-group pretest-posttest clinical trial ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 22 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** TEA combined with standard therapy **Intervention Names:** - Procedure: Thread embedding acupuncture (TEA) + standard therapy **Label:** Experimental **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental **Description:** * TEA : one-time TEA using 30 gauge TEA needle with 30 mm polydioxanone thread at CV3 through CV4, SP6 and ST36 bilaterally * Standard therapy : 2 mg dienogest daily for 8 weeks after TEA **Name:** Thread embedding acupuncture (TEA) + standard therapy **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Pain intensity measurement scale consists of 11 points (0-10). The higher the score, the more severe the pain intensity. A score of 0 means there is no pain at all, while a score of 10 means the pain is unbearable. **Measure:** Numeric rating scale (NRS) score **Time Frame:** Before treatment, week 4, week 8 #### Secondary Outcomes **Description:** Questionnaire measuring quality of life related to health status, specific for patients with endometriosis. The larger the number, the worse the health status. **Measure:** Endometriosis Health Profile-30 (EHP-30) score **Time Frame:** Before treatment, week 4, week 8 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Women aged 18-45 years. 2. Subjects diagnosed with endometriosis from laparoscopy, ultrasound, or histopathology. 3. Subjects experience at least one type of pain including pelvic pain, dysmenorrhoea, dyspareunia, dyschezia, or dysuria with a minimum NRS score of 4. 4. The subject has undergone endometriosis therapy with dienogest for at least 1 month but the NRS score is still ≥4. 5. Subjects are willing to follow research procedures and sign the informed consent form. Exclusion Criteria: 1. Subjects who have wounds, inflammation, infection, lumps, or eczema at the puncture site. 2. Pregnant or breastfeeding women. 3. Subjects with blood clotting disorders or who are taking blood thinning medication. 4. Have a history of diabetes mellitus, malignancy, psychiatric disorders, keloids, allergies to stainless steel or PDO threads. 5. Subjects who received surgical therapy in the last 3 months. 6. Subjects who have been undergoing acupuncture therapy in the last 2 weeks or TEA in the last 6 months. **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** setiawanmarshellia@gmail.com **Name:** Marshellia Setiawan, MD **Phone:** 6281221792616 **Role:** CONTACT **Contact 2:** **Email:** ec_fkui@yahoo.com **Name:** Marshellia Setiawan, MD **Phone:** 62213157008 **Role:** CONTACT #### Locations **Location 1:** **City:** Jakarta Pusat **Contacts:** ***Contact 1:*** - **Email:** ec_fkui@yahoo.com - **Name:** Cipto Mangunkusumo Hospital - **Phone:** 1 500 135 - **Role:** CONTACT **Country:** Indonesia **Facility:** Cipto Mangunkusumo Hospital **State:** Jakarta **Status:** RECRUITING **Zip:** 10430 #### Overall Officials **Official 1:** **Affiliation:** Indonesia University **Name:** Marshellia Setiawan, MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000091662 - Term: Genital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M7877 - Name: Endometriosis - Relevance: HIGH - As Found: Endometriosis - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life ### Condition Browse Module - Meshes - ID: D000004715 - Term: Endometriosis ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: M230930 - Name: Dienogest - Relevance: LOW - As Found: Unknown - ID: T312 - Name: Tea - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438731 **Brief Title:** Comparison of Two Methods in Pain Caused by Orogastric Tube Placement in Preterm Newborns **Official Title:** The Effect of Breast Milk and Knitted Octopus on the Pain Caused by Orogastric Tube Insertion in Preterm Newborns #### Organization Study ID Info **ID:** AIBU-SBF-MG-01 #### Organization **Class:** OTHER **Full Name:** Pamukkale University ### Status Module #### Completion Date **Date:** 2026-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-29 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Pamukkale University #### Responsible Party **Investigator Affiliation:** Pamukkale University **Investigator Full Name:** Melek Nur Guzel **Investigator Title:** researcher **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Aim : This study will be conducted to determine the effect of breast milk and knitted octopus in reducing pain caused by routine orogastric tube insertion in preterm newborns. Method : This study was planned as a randomized controlled trial. The study group will consist of 66 preterms with a gestational age of 32-34 weeks fed by orogastric tube. Informed Consent Form, Preterm Newborn Introduction Form, Physiologic Parameters Measurement Form and Premature Infant Pain Profile (PIPP) will be used in the study. The research will be conducted in the Neonatal Intensive Care Unit of a university hospital in Denizli province. Newborns in the breast milk group will be given oral breast milk before the procedure. Newborns in the knitted octopus group will be provided with the octopus touching various parts of their bodies as a tactile stimulation before the procedure. No intervention will be performed on newborns in the control group. Data will be obtained by the researcher from camera recording and patient file. In evaluating the data, continuous variables will be given as mean ± standard deviation and categorical variables will be given as number and percentage. Parametric and non-parametric tests will be used to examine the differences between groups. Hypothesis: It is expected to contribute to the development of a new approach in the pain management of preterm newborns by evaluating the effectiveness of breast milk and knitted octopus in reducing the pain caused by orogastric tube insertion in preterm newborns. **Detailed Description:** İNTRODUCTİON Preterm babies experience many problems in the postnatal period because they are anatomically and physiologically immature.Nutritional problems have an important place among these problems.In the first days of life, they are fed enterally via orogastric tube. Enteral nutrition is the process of giving the newborn's nutrition through a nasogastric (NG), orogastric (OG) or transpyloric tube.Baby feeding tube insertion causes pain.Although in the past years it was said that the newborn did not feel pain, the prenatal starts to feel it from the 20th week. When pain is not detected, the growth and development of the newborn is negatively affected.There are pharmacological and non-pharmacological methods in pain management. Touch is considered the most basic communication and is well developed. Breast milk increases immunity and ensures growth and development.The sense of taste is highly developed even in premature babies. There is no study in the literature comparing breast milk and the knitting octopus method together.Considering that orogastric tube application in newborns is a common clinical practice, it is important to minimize the side effects of this treatment method and increase the comfort of babies. Aim of the study: This study will be conducted to determine the effect of breast milk and knitted octopus in reducing pain caused by routine orogastric tube insertion in preterm neonates. Materials and Methods Type of Research The research will be conducted as a randomized controlled study. Location Characteristics and Time Where the Research Was Conducted The study will be conducted between March 2024 and March 2026 in preterm neonates who received an orogastric tube in the neonatal intensive care unit of a university hospital in a province in the western region of Turkey. In the hospital where the study was conducted, there are level 3, level 2 and maternal adaptation room in the neonatal intensive care unit. Approximately 31 nurses and 2 specialist doctors work in the neonatal intensive care unit. Population and Sample of the Study The study population will consist of newborns who received treatment and care in the Neonatal Intensive Care Unit of a university hospital in a province in the western region of Turkey between March 2024 and March 2026 and who meet the case selection criteria. The study sample will consist of preterm newborns with a gestational age of 32-34 weeks treated in the Neonatal Intensive Care Unit of the same hospital. Infants fed with orogastric catheter in the neonatal intensive care unit will be included in the sample. The effect size obtained in the reference study was found to be strong (F=0.695) (Şener Taplak and Erdem 2017). Assuming that a lower effect size (F=0.4) could be obtained, as a result of the power analysis performed for 3 groups, it was calculated that 80% power could be obtained at 95% confidence level when at least 66 infants (at least 22 infants for each group) were included in the study. Randomization Randomization in the research will be provided by the sealed envelope method. In the case of an infant meeting the sampling criteria, after obtaining signed informed consent from the parent, the researcher will give the newborn a letter placed in a sealed envelope and the newborns will be randomly assigned to groups. Which letter will represent which group will be determined at the beginning of the study using the closed opaque envelope method. Accordingly, letter C will be used for the control group, letter B for the knitted octopus group and letter A for the breast milk group. Blinding Single blinding (participants) will be used in the study. Participants will not be informed about which group they are in. Research Inclusion Criteria * Gestational week between 32-34 weeks * Postnatal age ≤ 37 weeks * Having breast milk * Weighing 1000 grams or more * Spontaneous breathing * Being fed with an orogastric tube * Not being exposed to a painful procedure at least half an hour before the interventions * Parental consent for the newborn to participate in the study Criteria for Exclusion from the Study * Having received ventilator support (may have received it before) * Any congenital anomaly of the face or oral cavity * Grade 3 and 4 intraventricular hemorrhage * Taking opioid or non-opioid analgesics * Repeated orogastric tube placement Application After the parents accept the study and complete the Informed Consent Form, the Preterm Newborn Introduction Form will be completed.Pain level will be evaluated by interpreting the camera image in accordance with the physiologic parameters measurement form and Premature Infant Pain Profile. Orogastric tube application is applied in neonatal intensive care unit to babies who cannot take by mouth.Orogastric tubes can be changed daily or during the day according to the needs of the newborn. Since the pain level of breast milk, knitted octopus and control group will be recorded with a camera during the orogastric catheter insertion procedure, the procedure will be performed only once. Breast Milk Group Preterm newborns in this group will be administered their own mother's milk with a sterile syringe as 1 ml single dose 2 minutes before orogastric tube insertion. During administration, the baby will not be allowed to suck the tip of the syringe and breast milk will be dripped onto the tongue. Nothing oral will be given 30 minutes before the procedure. Preterm newborn will be monitored by camera recording for 5 minutes before, during and 5 minutes after the procedure. Knitted Octopus Group The knitted octopus method will be applied to preterm newborns in this group before orogastric tube insertion. The arms of the knitted octopus will wrap around the baby's arms and legs, and its head will be on the baby's body. The preterm newborn will be monitored by camera recording for 5 minutes before the procedure, and for 5 minutes during and after the procedure. Control Group For preterm newborns in this group, no method will be applied before orogastric tube insertion and routine procedures will be performed. The preterm will be monitored for 5 minutes before birth, during the procedure cycle, and then by camera recording for 5 minutes. Data Collection Tools Informed Consent Form (Annex 1) It will include information such as the purpose of the research, that participation is voluntary, and that personal information will be kept confidential. Preterm Newborn Introduction Form (Annex 2) The form prepared by the researcher will include the group in which the newborn is included, mode of delivery, 1st and 5th minute apgar score, birth weight, gender, gestational age, postnatal age and duration of orogastric catheter insertion. Physiological Parameters Measurement Form (Annex 3) This form prepared by the researcher will help evaluate the pain, heart rate and oxygen saturation value while the orogastric tube is inserted. This form is preterm It was created to record the baby's heart rate and oxygen saturation value. During orogastric tube insertion, heart rate and oxygen saturation will be recorded 1 minute before the procedure, during the procedure, and 1 and 2 minutes after the procedure Premature Infant Pain Profile (PIPP) (Appendix 4) Stevens et al. Premature Baby Pain Scale ( Premature ) by (1996) baby Pain Profile - PIPP) has been developed. Stevens et al. (1996) found the Cronbach alpha value to be 0.71 for all items of the PIPP. (Apaydın Cırık 2019). Turkish validity and reliability study was conducted by Akcan and Yiğit (2015). In the study conducted by Akcan and Yiğit on preterm newborns between 26-36 weeks and 0-28 days old, the PIPP score was 4.0, 15.0 and 7.0 before, during and after invasive intervention. They found consistency between PIPP elements to be between 0.68 and 0.78, and homogeneity to be between 0.48 and 0.95 (Akcan and Yiğit 2015). In order to evaluate the baby's pain, the PIPP scale questions 7 items such as gestational age, behavioral status, highest heart rate value, lowest oxygen saturation value, forehead wrinkling, squinting of the eyes and widening of the nose wings. Each item; It is scored as 0, 1, 2 and 3, from best to worst. According to the Premature Baby Pain Profile, the baby's pain is evaluated based on the total score. Accordingly, the highest is 21 points and the lowest is 0 points. If the Premature Baby Pain Profile is between 0 and 6 points, the pain is considered mild, between 7 and 12 points, it is considered moderate, and between 13 and 21 points, the pain is considered severe. Preterm recorded with a camera device The behavioral responses of newborns at the 1st minute before the procedure , during the procedure, and at the 1st and 2nd minute after the procedure will be evaluated with PIPP. Tools and equipment to be used in the study; Camera Pulse Oximeter Device Oxygen Saturation Probe Injector Knitted Octopus Knitted octopus: The material must be washable and sterilizable so that the octopus can share the same space with the babies in the incubator, octopus parts such as eyes and mouth should be sewn, not plastic. Knitted octopuses must be crocheted from cotton yarns (100% cotton), 8/4 or 8/8 cotton, acrylic (washable at 60°C and must be hypoallergenic), fiber-filled 3.0 mm or 3.5 mm in size and protected from accidents . To avoid this, it is recommended that the tentacles (Junior \&Coelho 2020) be 20 to 22 centimeters long and consist of 8 tentacles with a head of 8 to 10 centimeters (Siqueira 2019). In line with this data, it is planned to knit 3 octopuses initially and use them alternately after appropriate cleaning methods. Ethical Dimension Ethical approval for the conduct of the research was received from Pamukkale University Non-Interventional Clinical Research Ethics Committee (10.01.2024 Decision number: E-60116787-020-474228) ; Institutional permission was obtained from Pamukkale University Hospital for the intensive care unit where the study will be conducted. Analysis Data will be analyzed with the SPSS 25.0 (IBM SPSS Statistics 25 software (Armonk, NY: IBM Corp.)) package program.Continuous variables will be given as mean ± standard deviation and categorical variables will be given as number and percentage. In examining the differences between groups, the significance test of the difference between two means and one-way analysis of variance will be used when parametric test assumptions are met, and Mann Whitney U test and Kruskal Wallis Analysis of Variance will be used when parametric test assumptions are not met. Differences between categorical variables will be examined with Chi square analysis. p \<0.05 will be considered statistically significant. Hypothesis: This study aims to investigate the effect of breast milk and knitted octopus on pain caused by orogastric tube insertion in premature newborns. However, there is no study in the literature comparing breast milk and the octopus knitting method together. Considering that orogastric tube application in newborns is a common clinical practice, it is important to minimize the side effects of this treatment method and increase the comfort of babies. After the completion of the study, it is thought that breast milk and knitted octopus will reduce the pain during orogastric tube insertion and can be used as a common practice in the clinic. ### Conditions Module **Conditions:** - Pain **Keywords:** - Pain - Knitted Octopus - Orogastric Tube - Breast Milk - Preterm ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Breast Mılk, Knıtted Octopus And Control Group ##### Masking Info **Masking:** SINGLE **Masking Description:** Single blinding (participants) will be used in the study. Participants will not be informed about which group they are in. **Who Masked:** - PARTICIPANT **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 66 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Preterm newborns in this group will be administered their own mother's milk with a sterile syringe as 1 ml single dose 2 minutes before orogastric tube insertion. During administration, the baby will not be allowed to suck the tip of the syringe and breast milk will be dripped onto the tongue. Nothing oral will be given 30 minutes before the procedure. **Intervention Names:** - Other: BREAST MILK **Label:** Breast Milk Group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** The knitted octopus method will be applied to preterm newborns in this group before orogastric tube insertion. The arms of the knitted octopus will wrap around the baby's arms and legs, and its head will be on the baby's body. **Intervention Names:** - Other: KNITTED OCTOPUS **Label:** Knitted Octopus Group **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** For preterm newborns in this group, no method will be applied before orogastric tube insertion and routine procedures will be performed. **Label:** Control Group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Breast Milk Group **Description:** The preterm will be monitored for 5 minutes before birth, during the procedure cycle, and then by camera recording for 5 minutes **Name:** BREAST MILK **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Knitted Octopus Group **Description:** The preterm will be monitored for 5 minutes before birth, during the procedure cycle, and then by camera recording for 5 minutes **Name:** KNITTED OCTOPUS **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** In order to evaluate the baby's pain, the PIPP scale questions 7 items such as gestational age, behavioral status, highest heart rate value, lowest oxygen saturation value, forehead wrinkling, squinting of the eyes and widening of the nose wings. Each item; It is scored as 0, 1, 2 and 3, from best to worst. According to the Premature Baby Pain Profile, the baby's pain is evaluated based on the total score. Accordingly, the highest is 21 points and the lowest is 0 points. If the Premature Baby Pain Profile is between 0 and 6 points, the pain is considered mild, between 7 and 12 points, it is considered moderate, and between 13 and 21 points, the pain is considered severe. **Measure:** Premature Infant Pain Profile (PIPP) **Time Frame:** one year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Gestational week between 32-34 weeks * Postnatal age ≤ 37 weeks * Having breast milk * Weighing 1000 grams or more * Spontaneous breathing * Being fed with an orogastric tube * Not being exposed to a painful procedure at least half an hour before the interventions * Parental consent for the newborn to participate in the study Exclusion Criteria: * Having received ventilator support (may have received it before) * Any congenital anomaly of the face or oral cavity * Grade 3 and 4 intraventricular hemorrhage * Taking opioid or non-opioid analgesics * Repeated orogastric tube placement **Maximum Age:** 34 Weeks **Minimum Age:** 32 Weeks **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** makyol162@posta.pau.edu.tr **Name:** Melek Nur GÜZEL **Phone:** 5346247995 **Role:** CONTACT **Contact 2:** **Email:** saltundag@pau.edu.tr **Name:** Sebahat ALTUNDAĞ **Role:** CONTACT #### Locations **Location 1:** **City:** Denizli **Contacts:** ***Contact 1:*** - **Email:** makyol162@posta.pau.edu.tr - **Name:** Melek Nur GÜZEL - **Role:** CONTACT **Country:** Turkey **Facility:** Pamukkale University Hospital **State:** Pamukkale **Status:** RECRUITING **Zip:** 20160 #### Overall Officials **Official 1:** **Affiliation:** BAĞLANTISIZ **Name:** Melek Nur GÜZEL **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** BAĞLANTISIZ **Name:** Sebahat ALTUNDAĞ **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Akkaya-Gul A, Ozyazicioglu N. Effect of pacifier and pacifier with dextrose in reducing pain during orogastric tube insertion in newborns: a randomized controlled trial. J Perinatol. 2024 May;44(5):717-723. doi: 10.1038/s41372-024-01948-w. Epub 2024 Mar 29. **PMID:** 38553602 **Citation:** Sener Taplak A, Erdem E. A Comparison of Breast Milk and Sucrose in Reducing Neonatal Pain During Eye Exam for Retinopathy of Prematurity. Breastfeed Med. 2017 Jun;12:305-310. doi: 10.1089/bfm.2016.0122. Epub 2017 Apr 17. **PMID:** 28414522 **Citation:** Srivastava G, Garg A, Chhavi N, Faridi M. Effect of kangaroo mother care on pain during orogastric tube insertion in low-birthweight newborns: An open label, randomised trial. J Paediatr Child Health. 2022 Dec;58(12):2248-2253. doi: 10.1111/jpc.16212. Epub 2022 Sep 21. **PMID:** 36131630 **Citation:** Bueno M. Combined non-pharmacological interventions minimise pain during orogastric tube insertion in preterm neonates. Evid Based Nurs. 2020 Aug 12:ebnurs-2020-103267. doi: 10.1136/ebnurs-2020-103267. Online ahead of print. No abstract available. **PMID:** 32796001 **Citation:** Calik C, Esenay F. The clinical effect of pacifier use on orogastric tube-fed preterm infants: A randomized controlled trial. J Pak Med Assoc. 2019 Jun;69(6):771-776. **PMID:** 31189280 #### See Also Links **Label:** THE EFFECT OF BREAST MILKING, WRAPPING AND FETAL POSITIONING METHODS IN REDUCING THE PAIN DUE TO OROGASTRIC TUBE INSERTION IN PRETERM NEWBORN. **URL:** http://acikerisim.akdeniz.edu.tr/bitstream/handle/123456789/4204/T05378.pdf?sequence=1&isAllowed=y **Label:** Effect of Mothers' Heartbeats Combined with Swaddling Technique on Orogastric Tube Insertion Pain among Preterm Neonates **URL:** https://ejhc.journals.ekb.eg/article_228203_86b0d67cb5eba3c36c41dfacc2c9dca4.pdf **Label:** Crochet octopuses help soothe premature babies in Araçatuba **URL:** https://g1.globo.com/sao-paulo/sao-jose-do-rio-preto-aracatuba/noticia/polvos-de-croche-ajudam-a-acalmar-bebes-prematuros-em-aracatuba.ghtml **Label:** Use of octopus as a humanization resource in the immediate response of vital signs of premature children in the neonatal intensive care unit **URL:** https://www.researchgate.net/publication/346101375_UTILIZACAO_DO_OCTOPUS_COMO_RECURSO_DE_HUMANIZACAO_NA_RESPOSTA_IMEDIATA_DOS_SINAIS_VITAIS_DE_PREMATUROS_NA_UNIDADE_DE_TERAPIA_INTENSIVA_NEONATAL/fulltext/5fbbc223299bf104cf6d7bb5/UTILIZACAO-DO-OCTOPUS-COMO-RECURSO-DE-HUMANIZACAO-NA-RESPOSTA-IMEDIATA-DOS-SINAIS-VITAIS-DE-PREMATUROS-NA-UNIDADE-DE-TERAPIA-INTENSIVA-NEONATAL.pdf **Label:** Use of crochet octopus for premature babies in the neonatal unit: an electronic news analysis **URL:** https://www.e-publicacoes.uerj.br/index.php/enfermagemuerj/article/download/43566/33044 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007752 - Term: Obstetric Labor, Premature - ID: D000007744 - Term: Obstetric Labor Complications - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases ### 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 ### Condition Browse Module - Browse Leaves - ID: M25869 - Name: Premature Birth - Relevance: HIGH - As Found: Preterm - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M10772 - Name: Obstetric Labor, Premature - Relevance: LOW - As Found: Unknown - ID: M10764 - Name: Obstetric Labor Complications - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000047928 - Term: Premature Birth ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438718 **Brief Title:** Spanish Linguistic Validation, Validity and Reliability Test of Frail´BESTest in Elderly Institutionalized Frail People **Official Title:** Spanish Language Validation, Validity and Reliability Testing of Frail´BESTest in Frail Institutionalized Residents Over 60 Years of Age With Mild Cognitive Impairment #### Organization Study ID Info **ID:** Validation Frail´BESTest #### Organization **Class:** OTHER **Full Name:** Instituto de Investigación Sanitaria Aragón ### Status Module #### Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Instituto de Investigación Sanitaria Aragón #### Responsible Party **Investigator Affiliation:** Instituto de Investigación Sanitaria Aragón **Investigator Full Name:** Sandra Calvo Carrión **Investigator Title:** PhD in Health Sciences **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aging of the global population presents significant social and health challenges. In Aragón, 15% of the population is between 65 and 79 years old, and the over-aging index is 16.6%, higher than the national average. This aging necessitates promoting healthy aging and maintaining functional capacity in advanced ages. Currently, 15% of the Aragonese population is potentially dependent, a figure that rises to 26% among those over 85 years old. The decline in functional capacity is due to auditory, visual, joint, and proprioceptive issues, resulting in increased vulnerability to falls, which are a significant cause of death among the elderly. The frailty syndrome, although common with aging, is not inevitable and is characterized by the loss of functional capacity and increased risk of falls and hospitalization. To assess this capacity in frail individuals, specific tools like the Mini-Motor Test, the Morton Mobility Index, and the Elderly Mobility Scale exist. The BESTest, developed in 2009, evaluates balance but is time-consuming to administer, leading to the creation of a shorter version, the Mini BESTest. However, both can be limiting for frail individuals. To address these limitations, the Frail'BESTest was developed, evaluating six balance subsystems and being suitable for frail individuals, making it a valid and sensitive tool in clinical practice. This research project aims to develop tools that identify balance problems in frail individuals with mild cognitive impairment, allowing for specific interventions to reduce the risk of falls. **Detailed Description:** This is a cross-sectional study consisting of two phases. In the first phase, the linguistic-transcultural validation of the Frail'BESTest will be carried out in a population (which we will call group A), which will be made up of people over 65 years of age who live in a community, who do not present cognitive impairment and whose physical functional state is preserved. In a second phase of the study, the validity and reliability of the test will be analysed in frail institutionalised people with mild cognitive impairment. For this purpose, frail people with mild cognitive impairment (group B) and frail people with no cognitive impairment (group C), all of them over 65 years of age, will be selected. ### Conditions Module **Conditions:** - Frail Elderly Syndrome - Mild Cognitive Impairment **Keywords:** - Fragility - Mild Cognitive Impairment - Older adult - Institutionalised ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 230 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This Cross-sectional study consists of five phases. PHASE 1 \[T1\] Consist on the linguistic validation and it will be carried out the transcultural adaptation of Frail'BESTest in a population sample (named group A), which will be made up of 30 individuals over 60 years of age, community living independently in their houses, cognition preserved, who have a preserved physical functional status, and able to stand up still, without assistive devices for 10s or over (Group A). PHASE 2 \[T2\] consist on reliability. One subgroup (GROUP B and GROUP C) of institutionalized frail aged participants, n=30 with mild cognitive impairment (named group B) and 30 without mild cognitive impairment (named group C) will be tested. We will examine between raters reliability and test-retest reliability. PHASE 3 \[T3\] consisting on construct validity. PHASE 4 \[T4\] consisting on predictive falls/concurrent validity. PHASE 5 \[T4\] consisting on predictive decease/concurrent validity. **Label:** Validation group ### Outcomes Module #### Primary Outcomes **Description:** 6 balance systems are tested, with between 2-6 tests per balance system. The balance systems tested are: A: anticipations, B: reactions, C: locomotion, D: sensorial orientation, E: biomechanical constraints and F: gait symmetry. All tests or criteria are scored dichotomously, with 0 for negative results and 1 for positive results. The highest and best possible score for the Frail'BESTest is 26 and the lowest is 0. A. Proactive motor control anticipatory maximum score is 5 and the minimum score is 0 (equivalent to 19%). B. Reactive motor control - reactions - maximum score 2 and minimum score 0 (equivalent to 8%). C. Locomotion and gait - maximum score 6 and minimum score 0 (equivalent to 23%) D. Static postural control maximum score 3 and minimum score 0 (equivalent to 12%). E. Biomechanical restrictions maximum score is 6 and the minimum score is 0 (equivalent to 23%). F. Gait symmetry maximum score is 4 and the minimum score is 0 (equivalent to 15%). **Measure:** Frail'BESTest: assesses static, dynamic balance and mobility **Time Frame:** Baseline (T0) and 7 days (T1) following baseline. #### Secondary Outcomes **Description:** It is a battery that evaluates functional performance in three functional activities and measures the ability to: 1) maintain three different conditions of static balance for 10 seconds, 2) the time it takes to walk 4 meters and 3) stand up and sit down from a chair 5 consecutive times. Depending on the result, each of the activities is scored from 0 to 4 points, with the maximum possible score being 12 points. **Measure:** The Short Physical Performance Battery (SPPB): assesses functional performance **Time Frame:** Baseline (T0) and 7 days (T1) following baseline. **Description:** The TUG test (Timed Up and go (TUG) measures the functional mobility of the lower limbs. The patient sits on the chair and leans back against the back of the chair; the soles of the feet must be on the floor. On the command "Go"," the patient gets up from the chair (he is not restricted when getting up from the chair, he can use his upper extremities), walks 3 m at a fast, safe pace, turns around, goes back to the chair and sits down. The patient chooses the side on which the turn is to be performed. The timing starts with the instruction "Go" and ends when the patient is seated (buttocks touching the chair). **Measure:** Timed up and Go test (TUG): assess lower limb function **Time Frame:** Baseline (T0) and 7 days (T1) following baseline. **Description:** To calculate dual-task costs of naming on gait, two tests of gait are required. Test 1. Test of single gait at comfortable speed. A test of gait speed assesses an individual's functional mobility. Gait speed is calculated with the time taken to walk 10m distance on level surfaces at their comfortable speed over the entire distance. Examinees will be time once the first foot passes path line; the time is stopped once the first foot enters the 10m path line. Two trials are given. Analysis maximum speed obtained. Test 2. Test of gait speed dual task assesses an individual's functional mobility while naming cities from the country patients belong (cognitive activity). The procedure to record time will be the same before. Gait speed will be calculated: * Dual task gait speed (m·s-1) = 10m /Time taken to walk 10m naming cities * Dual Task Cost of naming on Gait Speed (DTC-GS) will be calculated using the formula: * DTC-GS \[%\] = 100 · (single-task value - dual-task value)/single-task value **Measure:** Dual task cost of naming on gait speed: assesses the ability of executing two tasks (naming and walking) in this case the effect of cognitive task on gait speed. **Time Frame:** Baseline (T0) and 7 days (T1) following baseline. **Description:** Quantifies subjects' ability executing two tasks concurrently (naming and walking). Test-1: The test of single cognitive task consists of naming towns for 30 seconds. The patient will be seated on a chair. The calculation of the number of towns correctly named per second will be recorded. DT Number of towns per seg = number of towns /10m gait dual task (seg) Test-2. Test of gait speed dual task results. While the patient performs the test it will record the time taken to walk 10m distance on level surfaces and the number of cities in the country correctly named, repeated during the 10-meter march. The calculation of the number of towns correctly named per second will be recorded Only one trial is given Dual task cost of gait on naming (DTC-N): * Dual-task Number of cities per sec = correct number of cities /10m gait dual task (seg) * Dual Task Cost of Gait on Naming (DTC-N) will be calculated: * DTC-N \[%\] = 100 · (single-task value - dual-task value)/single-task value **Measure:** Dual task cost of gait on naming: is the ability executing two tasks (naming and walking) and the effect gait activity on naming task. **Time Frame:** Baseline (T0) and 7 days (T1) following baseline. **Description:** The MiniBESTest was developed, and it is having been validated as a shorter version of the original BESTest to assess complementary systems that contribute to balance function. It aims to target and identify 6 different balance control systems so that specific rehabilitation approaches can be designed for different balance deficits. The tests include functional tasks involving several high-level exercises to assess the balance function, which may be even more difficult in case of frailty 1.1. TASKS Mini BESTest is a 14-item test scored on a 3-level ordinal scale (0-2) Total score = 32 points per test directions as we will specify use of both left and right data, thus calculating data based on 32. Assesses dynamic balance, a unidimensional construct and includes 14 items addressing 4 of the 6 sections of the original BESTest: I) Anticipatory postural adjustments II) Reactive postural control III) Sensory orientation IV) Dynamic gait. **Measure:** The Mini Balance Evaluation System (MiniBESTest): assess complementary systems that contribute to balance function using static, dynamic balance test and mobility test **Time Frame:** Baseline (T0) and 7 days (T1) following baseline. **Description:** The patient can use any assistive devices during the test. The test comprises two short sections that contain one examining static balance abilities in a chair and then standing, and the other gait. Total POMA consists of 16 items: 9 balance (POMA-B) and 7 gait (POMA-G) items. A 3-point ordinal scale, ranging from 0-2, where highest score indicates independence with each test item. 2.1. TASKS POMA has 2 sections 1) Assesses balance abilities in a chair and in standing position and 2) Assesses dynamic balance during gait. Total balance score is16 and gait 12; total Test score 28. Balance Subscale The patient is to sit in an armless chair and will be asked to rise and stay standing. The patient will then turn 360° and then sit back down. This is to test the patients' balance. At gait sub-scale the patient will have to walk a few meters at a normal speed, followed by turning and walking back at a "fast but safe" speed. The patient will then sit back down. **Measure:** Performance Oriented Mobility Assessment (POMA): is also known as Tinetti test. It assesses balance and mobility. **Time Frame:** Baseline (T0) and 7 days (T1) following baseline. **Description:** Falls are defined as an unexpected event in which the participants come to rest on the ground, floor, or lower level. The number of falls, will be obtain from medical history records of nursing homes. **Measure:** Falls. **Time Frame:** 6 months (T2) Following baseline Test. **Description:** Deceases and time to patient's decease will be obtain from medical history records of nursing homes. **Measure:** Patient's decease. **Time Frame:** 1 year (T3) following baseline. **Description:** Subjects' ability for executing two tasks concurrently (counting backwards in threes while doing a mobility test named TUG. To calculate dual-task costs of counting backwards on TUG The test is conducted single (TUG) and dual tasking, counting backwards in three (TUG-3). Two trials will be record for each condition and the best them will use for further analysis. Test-1-TUG. The patient sits with his/her back against the chair; the soles of feet must be on the ground. On the command "Go," the patient rises from the chair, walks at fast pace safe manner for 3m, turns, walks back to the chair and sits down. Test-2-TUG-3. Records time needed to complete TUG test while counting backward by threes. Different starting numbers will be use for the counting tasks. Dual Task Cost of counting backwards in threes on TUG (DTC-3-TUG) will be calculate using the formula: DTC-3-TUG \[%\] = 100 · ((single-task value - dual-task value)/single-task value)). **Measure:** Dual task cost of counting backwards on Timed up and Go (TUG): assesses the ability of executing two tasks (counting backwards and performing a mobility test) on the mobility task. **Time Frame:** Baseline (T0) and 7 days (T1) following baseline. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participants should be able to maintain 10seconds stand feet apart without assistance The Validity of FRAILBESTest in mild cognitive impairment institutionalized patients will be made of subgroup categories: Frail/Non-frail; Cognition preserved/Mild cognitive impairment patients and Institutionalized patients/community living individuals. * Frailty will be determine by Fried phenotype Those scoring 3 or more out of 5 will be classify as frail and those scoring 2 or less as non-frail individuals. Mini-Mental State Examination (MMSE) cognition status could be preserved or altered (Score \>24-30). * Community living individuals will be non-frail and cognition should preserved they will be assign to Group A. * Frail institutionalized individual's (scoring from 24 to 26 at MMSE) will be assign to Group B Frail institutionalized individual's (scoring = or \> to 27 at MMSE) will be assign to Group C Non frail Institutionalized individuals with cognition preserved (scoring = or \> to 27 at MMSE) will be assign to group D. Exclusion Criteria: * Orthopedic unstable conditions * Moderate or severe cognitive status Score \<24 at MMSE * Inability to understand indications or communicate with testers. * Sustaining severe cardiac, vascular or respiratory diseases or conditions that contraindicate physical activity * Presenting a condition for which, in the opinion of the researchers, the evaluation may pose a risk to their health * Not having autonomy to decide about their voluntary participation in the study **Healthy Volunteers:** True **Maximum Age:** 100 Years **Minimum Age:** 60 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** * Group A: Community Living, Non-Frail individuals Cognition preserved (n=30). * Group B: Institutionalized Frail with mild cognitive impairment n=240 (divided in two groups, n= 30 and n=210). * Group C: Institutionalized Frail without cognitive impairment (n=40). * Group B: will be obtained from the users of the residences for the elderly of the Fundación Rey Ardid in Zaragoza: Residencia Rosales and Residencia Juslibol. The recruitment will screen by the physiotherapist working in both residences by a verbal invitation. . * Group C: will be obtained from the users of Casa Amparo (Zaragoza) and the residences of the Federico Ozanam Foundation: Perpetuo Socorro (Garrapinillos), CAI-Ozanam Oliver, San Antonio de Padua, Ibercaja Ozanam La Magdalena, Ozanam Santa Isabel and María Auxiliadora (María de Huerva), Hermanitas de los pobres desamparados and the Mazaruba residence in Zaragoza. The authorised health personnel from each of the centres will screen participants and invite them. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** sandracalvo@unizar.es **Name:** Sandra Calvo, PhD **Phone:** +34 661833194 **Role:** CONTACT **Contact 2:** **Email:** mpdomin@unizar.es **Name:** María del Pilar Domínguez Oliván, PhD **Phone:** +34 876554461 **Role:** CONTACT #### Locations **Location 1:** **City:** Zaragoza **Contacts:** ***Contact 1:*** - **Email:** sandracalvo@unizar.es - **Name:** Sandra Calvo, PhD - **Phone:** +34 661833194 - **Role:** CONTACT ***Contact 2:*** - **Email:** mpdomin@unizar.es - **Name:** María del Pilar Domínguez Oliván, PhD - **Phone:** +34 876554461 - **Role:** CONTACT **Country:** Spain **Facility:** Universidad de Zaragoza **Status:** RECRUITING **Zip:** 50009 #### Overall Officials **Official 1:** **Affiliation:** Universidad de Zaragoza **Name:** María del Pilar Domínguez Oliván, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003072 - Term: Cognition Disorders - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M29705 - Name: Cognitive Dysfunction - Relevance: HIGH - As Found: Mild Cognitive Impairment - 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 ### Condition Browse Module - Meshes - ID: D000060825 - Term: Cognitive Dysfunction ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438705 **Brief Title:** 99mTc Labeled FAP Targeted Molecular Probe in Early Diagnosis of Tumors **Official Title:** Clinical Application of a Novel 99mTc Labeled Fibroblast Activating Protein (FAP) Targeted Molecular Probe in Early Diagnosis of Tumors #### Organization Study ID Info **ID:** KY20240419-08 #### Organization **Class:** OTHER **Full Name:** Nanjing First Hospital, Nanjing Medical University ### Status Module #### Completion Date **Date:** 2026-01-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-01-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Nanjing First Hospital, Nanjing Medical University #### Responsible Party **Investigator Affiliation:** Nanjing First Hospital, Nanjing Medical University **Investigator Full Name:** Feng Wang **Investigator Title:** Chief physician **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** At present, radiopharmaceuticals targeting FAP have been developed for the diagnosis and treatment of various tumors. Considering the problems of fast tumor tissue clearance and short retention time in small molecule FAP inhibitors based on quinoline rings, this project optimized their ligands and developed a new FAP targeted technetium labeled molecular imaging probe for SPECT/CT imaging research to evaluate its safety in clinical application and its effectiveness in tumor diagnosis. ### Conditions Module **Conditions:** - Head and Neck Tumor - Lung Cancer - Pancreatic Cancer ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** The subjects were intravenously injected with 99mTc labeled FAPI imaging agent, and drank 300-500ml of water after administration. SPECT-CT imaging was performed 60 minutes later **Name:** SPECT-CT imaging **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Compare the lesion site with surrounding normal tissue to evaluate whether there is a significant increase in radioactive uptake. Select the lesion in the abnormal area of the image and draw a 3D area of interest (ROI) to obtain the average lesion volume count (T). Calculate the tumor target/non target value (T/NT) statistically **Measure:** Tumor uptake **Time Frame:** 1 hour after administering the probe ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Voluntary subjects, patients or their legal representatives sign informed consent; * Volunteers are of any gender and aged between 18 and 75 years old, including the cut-off value; * Other imaging methods found tumor occupying; * Patients with pre-treatment tumors for whom surgery or biopsy may be performed to obtain final pathological results. * Kidney glomerular filtration rate(GFR)\>50 ml/min, effective renal plasma flow(ERPF)\>280 ml/min, platelet count (PLT) \>75 000/μL, white blood cell (WBC) \>3000/μL, alanine aminotransferase ALT, aspartate aminotransferase AST less than 3 times the normal value. Exclusion Criteria: * People who have a history of allergy to similar drugs , allergic constitution or are currently suffering from allergic diseases; * Is conducting clinical research on other drugs, or has participated in clinical research on any drugs (excluding vitamins and minerals); * Have other clinical problems that are difficult to control (such as hepatitis C virus infection or active hepatitis B, or other serious chronic infections and serious mental, neurological, cardiovascular, respiratory and other diseases); * Obvious abnormal liver and kidney function, GFR less than 50 ml/min; * Tumor load is greater than 50%, or there is obvious spinal cord compression; * The expected survival period is less than half a year; Chemotherapy was performed within 6 months. * Have severe acute concomitant diseases or serious refractory mental disorders; * Pregnant and lactating women (where pregnancy is defined as a positive urine pregnancy study); * Patients whose physical condition is not suitable for radiological examination; * Other situations deemed inappropriate by the investigator to participate in the trial. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** This study was mainly conducted by SPECT CT imaging, and a total of 20 cases were planned to be enrolled, which were evaluated by 2 attending physicians of nuclear medicine or above according to various measurement data of the subjects ### Contacts Locations Module #### Locations **Location 1:** **City:** Nanjing **Contacts:** ***Contact 1:*** - **Email:** fengwangcn@hotmail.com - **Name:** Feng Wang, Ph.D. - **Phone:** 86-025-52271455 - **Role:** CONTACT **Country:** China **Facility:** Nanjing First Hospital **State:** Jiangsu **Status:** RECRUITING **Zip:** 210006 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: HIGH - As Found: Head and Neck Tumors - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M13110 - Name: Pancreatic Neoplasms - Relevance: LOW - As Found: Unknown - ID: T4387 - Name: Pancreatic Cancer - Relevance: HIGH - As Found: Pancreatic Cancer ### Condition Browse Module - Meshes - ID: D000006258 - Term: Head and Neck Neoplasms ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438692 **Brief Title:** Ablation Strategies for Persistent Atrial Fibrillation Combined With Heart Failure **Official Title:** Clinical Study on the 2C3L Strategy Based on Marshall Venous Chemoablation for the Treatment of Persistent Atrial Fibrillation Combined With Heart Failure #### Organization Study ID Info **ID:** 05949801 #### Organization **Class:** OTHER **Full Name:** Qianfoshan Hospital ### Status Module #### Completion Date **Date:** 2025-06-16 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-06-16 **Type:** ESTIMATED #### Start Date **Date:** 2022-06-16 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-01-02 **Study First Submit QC Date:** 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Qianfoshan Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** (1) To evaluate the efficacy and safety of "2C3L" strategy combined with VOM anhydrous ethanol chemical ablation for persistent atrial fibrillation complicated with heart failure; (2) To evaluate the effectiveness of high-efficiency ablation of atrial fibrillation complicated with heart failure. **Detailed Description:** 2C3L ablation strategy: The electroanatomical mapping system was the Carto 3 V6 system of Johnson \& Johnson, and the high-density mapping electrode (Pentaray) and cold saline perfusion pressure catheter (ST-SF) were used for ablation. Ablation parameters were set as follows: ablation power of 45 to 50 Watts (reduced to 25 Watts in the coronary vein and 35 Watts in the endocardium of the mitral isthmus), upper temperature limit of 43 ° C, and saline infusion rate of 15 mL/ min (changed to 30 mL/min in coronary veins), the pressure was controlled at 5-15 g, and the target AI was set: 480-500 for the anterior wall of the pulmonary vein, 350-380 for the posterior wall, 450 for the top of the left atrium, 600 for the mitral valve isthmus, and 450 for the tricuspid valve isthmus. A single catheter procedure was performed in the left atrium, and the ablation endpoint was to achieve continuous bilateral circumferential pulmonary vein damage with loss of intrapulmonary vein potential, which was further confirmed after conversion to sinus rhythm. During left pulmonary vein ablation, the top and posterior wall of left pulmonary vein were ablated first. If pulmonary vein isolation was achieved, no further intervention was performed on the anterior edge of left pulmonary vein. The ablation of the mitral annulus started from about 1 cm away from the junction between the VOM and the coronary vein, and continued to the low-voltage area. Ablation was performed in the corresponding epicardium, namely the coronary vein. Finally, the isthmus of the tricuspid valve was ablated from 6:00 to the inferior vena cava. If the patient still had atrial fibrillation or atrial flutter after the above ablation, 200 J direct current was used to cardioversion the sinus rhythm, and the complete block of each ablation path was verified by pacing during sinus rhythm. In the ablation-only group, catheter ablation was used only to these end points. The operation time was from the start of venipuncture to the removal of sheath tube. The melting time was the cumulative ablation time. VOM absolute ethanol chemical ablation: The SL1 long sheath was delivered to the opening of the coronary sinus through the right femoral vein, and the right coronary finger guide tube (JR4) was placed to the opening of the coronary sinus. The guide tube was rotated clockwise, and the tip of the guide catheter was pointed in the posterior-superior direction under the right anterior oblique 30 degree fluoroscopy. The BMW guide wire was sent to the proximal end of VOM, and the OTW balloon was sent to the middle and distal end of VOM. The balloon was expanded, and after the BMW guide wire was removed, the course of VOM and whether there was regurgitation were observed by angiography to ensure the complete occlusion of VOM. Anhydrous ethanol was injected in fractions via the OTW balloon. ### Conditions Module **Conditions:** - Atrial Fibrillation - Heart Failure ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 130 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Ablation Procedure：2C3L **Intervention Names:** - Procedure: 2C3L **Label:** 2C3L group **Type:** SHAM_COMPARATOR #### Arm Group 2 **Description:** Ablation Procedure：2C3L combined with Marshall ethanol ablation **Intervention Names:** - Procedure: VOM ethanol chemical ablation and 2C3L **Label:** 2C3L-plus group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 2C3L-plus group **Description:** Annular pulmonary vein ablation, mitral isthmus line ablation, tricuspid isthmus line ablation, apex line ablation，anhydrous alcohol ablation of VOM **Name:** VOM ethanol chemical ablation and 2C3L **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - 2C3L group **Description:** Annular pulmonary vein ablation, mitral isthmus line ablation, tricuspid isthmus line ablation, apex line ablation **Name:** 2C3L **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Postoperative recurrence rate was evaluated by holter monitoring. **Measure:** Postoperative recurrence rate **Time Frame:** 12 months after operation ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. age:18y-80y 2. First ablation on non valvular atrial fibrillation 3. Persistent atrial fibrillation with LVEF≤40% 4. The patient has symptoms related to atrial fibrillation, including but not limited to palpitations, premonitory syncope, syncope, fatigue, and shortness of breath, and is evaluated for clinical cardiac function between NYHA II-IV levels 5. No response to antiarrhythmic drugs, unacceptable side effects, or unwillingness to take antiarrhythmic drugs. Exclusion Criteria: 1. Paroxysmal atrial fibrillation 2. Atrial fibrillation secondary to obvious reversible causes 3. Echocardiography: Parasternal long axis section, left atrial diameter ≥ 60mm 4. LVEF \>40% 5. Receiving dual antithrombotic therapy 6. Contraindications to the use of oral anticoagulants 7. Contraindications to right or left cardiac catheterization 8. pregnancy 9. Life expectancy\<1 year (such as advanced malignant tumors, advanced kidney disease, etc.) 10. Unable to discontinue antiarrhythmic drugs due to reasons other than atrial fibrillation **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** hyperhhs@163.com **Name:** Hesheng Hu **Phone:** 13589112300 **Role:** CONTACT **Contact 2:** **Email:** xinran0207@126.com **Name:** Xinran Li **Phone:** 17686619036 **Role:** CONTACT #### Locations **Location 1:** **City:** Jinan **Contacts:** ***Contact 1:*** - **Name:** Hesheng Hu - **Phone:** 13589112300 - **Role:** CONTACT **Country:** China **Facility:** Hesheng Hu **State:** Shandong **Status:** RECRUITING **Zip:** 250012 #### Overall Officials **Official 1:** **Affiliation:** The First Affiliated Hospital of Shandong First Medical University **Name:** Hesheng Hu **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000001145 - Term: Arrhythmias, Cardiac - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4586 - Name: Atrial Fibrillation - Relevance: HIGH - As Found: Atrial Fibrillation - ID: M9421 - Name: Heart Failure - Relevance: HIGH - As Found: Heart Failure - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M4453 - Name: Arrhythmias, Cardiac - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006333 - Term: Heart Failure - ID: D000001281 - Term: Atrial Fibrillation ### Intervention Browse Module - Ancestors - ID: D000000891 - Term: Anti-Infective Agents, Local - ID: D000000890 - Term: Anti-Infective Agents - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M3777 - Name: Ethanol - Relevance: HIGH - As Found: Chronic Kidney Disease - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M4215 - Name: Anti-Infective Agents, Local - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000431 - Term: Ethanol ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438679 **Brief Title:** 3T Therapy in the Treatment of MDA5-positive Dermatomyositis **Official Title:** A Single-centric Prospective Single-arm Study of 3T Therapy in the Treatment of MDA5-positive Dermatomyositis #### Organization Study ID Info **ID:** IRB2024-0285 #### Organization **Class:** OTHER **Full Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University ### Status Module #### Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2024-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-19 **Type:** ACTUAL **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University #### 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:** The goal of this clinical trial is to learn if a combination of tacrolimus, tafocitinib and thalidomide (3T therapy) works to treat severe MDA5 positive dermatomyositis in adults. It will also learn about the safety of 3T therapy. The main questions it aims to answer are: Does 3T therapy prolong the overall survival time of MDA5 positive dermatomyositis? What medical problems do participants have when taking 3T therapy? Participants will: Take 3T therapy every day for 12 months Visit the clinic once every 2 weeks for checkups and tests ### Conditions Module **Conditions:** - Dermatomyositis **Keywords:** - MDA5 - dermatomyositis - 3T therapy - effectiveness ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 133 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This is a single arm experiment **Intervention Names:** - Drug: Tofacitinib 5 MG **Label:** 3T therapy arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 3T therapy arm **Description:** Tofacitinib 5mg BID+thalidomide 50mg BID+tacrolimus 0.1mg/kg QD per oral **Name:** Tofacitinib 5 MG **Other Names:** - tacrolimus - thalidomide **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The overall survival rate at the end of observation **Measure:** Overall survival rate **Time Frame:** 26 weeks **Description:** The overall treatment associated adverse effects incidence during the clinical trial **Measure:** Overall TE incidence **Time Frame:** 26 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged 18 or above at the time of screening * Diagnosis of MDA5-positive dermatomyositis (EULAR/ACR) during screening, and the following 3 items are met at the same time: 1. The MDA5 titer during screening is ++ or +++; 2. Mild or above decrease in pulmonary diffusing function at screening and baseline; 3. Interstitial extravasation seen on chest CT at screening and baseline * Agree to receive highly effective contraception or sterilized * Subjects are willing and able to comply with study visits and related procedures * Subjects have the ability to understand the research requirements and procedures, voluntarily participate in clinical trials and sign the ICF Exclusion Criteria: * Have received any drug in 3T treatment in the past, but had poor response (including treatment failure or unacceptable treatment-related adverse reactions) * Have received lenalidomide, cyclosporine, or other highly selective or pan-selective JAK inhibitors such as lenalidomide or cyclosporine or other highly selective or pan-selective JAK inhibitors such as baricitinib within 2 weeks before visit D1 or within 5 drug half-lives (if known) agent. * Have received treatment with an immune cell depleting agent (such as rituximab) within 6 months before the D1 visit. * Have received any investigational drug/treatment within 4 weeks or 5 drug half-lives (if known) before visit D1, whichever is longer. * Known or suspected history of immunosuppression/deficiency (including but not limited to invasive opportunistic infections such as aspergillosis, coccidioidomycosis, histoplasmosis, AIDS, listeriosis, even if the infection has resolved) within 6 months prior to visit D1, or there are unusually frequent recurring or persistent infections. * There is a history of malignant tumors within 5 years before the D1 visit (except for completely cured cervical carcinoma in situ or non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma or thyroid malignant tumors or other malignant tumors considered by the researcher to be amenable to 3T treatment). * Positive hepatitis B surface antigen (HBsAg) during screening; or positive hepatitis B core antibody (HBcAb) and positive HBV-DNA; or positive hepatitis C antibody and positive HCV ribonucleic acid (RNA) polymerase chain reaction; or human immune HIV-deficiency virus (HIV) serology was positive. * Subjects with active tuberculosis, latent tuberculosis, or a history of non-tuberculous mycobacterial infection at the time of screening. * Have a history of systemic hypersensitivity reaction to any drug or matrix or excipient in 3T therapy. * Have been vaccinated within 12 weeks before the D1 visit, or plan to receive a live (attenuated) vaccine during the study. * Pregnant or lactating women, or subjects who plan to become pregnant or lactating during the study. * Any other circumstances in which the researcher determines that it is not appropriate to participate in this study **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Hangzhou **Country:** China **Facility:** Zhejiang University School of Medicine Second Affiliated Hospital **State:** Zhejiang **Zip:** 310009 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000017285 - Term: Polymyositis - ID: D000009220 - Term: Myositis - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M7077 - Name: Dermatomyositis - Relevance: HIGH - As Found: Dermatomyositis - ID: M19579 - Name: Polymyositis - Relevance: LOW - As Found: Unknown - ID: M12172 - Name: Myositis - 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: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: T1814 - Name: Dermatomyositis - Relevance: HIGH - As Found: Dermatomyositis - ID: T4623 - Name: Polymyositis - Relevance: LOW - As Found: Unknown - ID: T3001 - Name: Idiopathic Inflammatory Myopathy - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003882 - Term: Dermatomyositis ### Intervention Browse Module - Ancestors - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000065095 - Term: Calcineurin Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000007917 - Term: Leprostatic Agents - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000020533 - Term: Angiogenesis Inhibitors - ID: D000043924 - Term: Angiogenesis Modulating Agents - ID: D000006133 - Term: Growth Substances - ID: D000006131 - Term: Growth Inhibitors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000075242 - Term: Janus Kinase Inhibitors - ID: D000047428 - Term: Protein Kinase Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M16559 - Name: Thalidomide - Relevance: HIGH - As Found: Open-Label Study - ID: M18950 - Name: Tacrolimus - Relevance: HIGH - As Found: 3 weeks - ID: M258018 - Name: Tofacitinib - Relevance: HIGH - As Found: Periodontitis - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M30452 - Name: Calcineurin Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - 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: M22318 - Name: Angiogenesis Inhibitors - Relevance: LOW - As Found: Unknown - ID: M9231 - Name: Growth Inhibitors - Relevance: LOW - As Found: Unknown - ID: M1474 - Name: Janus Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M25820 - Name: Protein Kinase Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000013792 - Term: Thalidomide - ID: D000016559 - Term: Tacrolimus - ID: C000479163 - Term: Tofacitinib ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438666 **Acronym:** PeditCDS **Brief Title:** Effects Obtained at Manual Function After Applying Anodic Transcranial Direct Current Stimulation (tCDS) in Children With Spastic Hemiparetic Cerebral Palsy **Official Title:** A Quasi Experimental Study About the Effects Obtained at Manual Function After Applying Anodic Transcranial Direct Current Stimulation in Children With Spastic Hemiparetic Cerebral Palsy #### Organization Study ID Info **ID:** tDCS_2024UMA #### Organization **Class:** OTHER **Full Name:** University of Malaga ### Status Module #### Completion Date **Date:** 2027-03-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-12-23 **Type:** ESTIMATED #### Start Date **Date:** 2025-03-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-31 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Jorge Manuel Góngora Rodríguez #### Lead Sponsor **Class:** OTHER **Name:** University of Malaga #### Responsible Party **Investigator Affiliation:** University of Malaga **Investigator Full Name:** Rocío Martín Valero **Investigator Title:** Director **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False ### Description Module **Brief Summary:** Spastic Hemiparetic Cerebral Palsy (SHCP) uses to limit the manual function. Using anodic transcranial direct current stimulation, it is possible to activate certain cerebral areas depending on where the electrodes are. This study will use this kind of stimulation on the contralateral primary motor cortex of the affected upper limb and analyze the effects. **Detailed Description:** It has been designed a single-arm prospective longitudinal quasi-experimental pilot clinical study following the SPIRIT 2013 statement. It will value the time that the children spend doing the bimanual activities described by the Children's Hand-Use Experience Questionnaire (CHEQ), it will also value the subjective experience doing those activities; it will analyze the active movement (Fugl-Meyer for upper limb), spasticity (modified Ashworth), manual strength (dynamometry) and the recruitment improvement (surface electromyography) too. This study will apply the anodic transcranial direct current stimulation over 20 children between 14-18 years old. The protocol that it will follow is the next one: 3 days to value the outcome measures, 4 days (1 session per day of 17 minutes and 30 seconds) to apply the protocol of anodic transcranial direct current stimulation (0,6 mA of intensity). It will use the EPTE V07 Bipolar System by IONCLINICS ®; 3 days to value the outcome measures studying the effects produced at the affected upper limb. Another evaluation will be realized 3 weeks after the last session of anodic transcranial direct current stimulation to know if the effects obtained last at medium-long term. ### Conditions Module **Conditions:** - Hemiparetic Cerebral Palsy **Keywords:** - Cerebral Palsy - Transcranial Direct Current Stimulation - Upper Limb ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** 20 participants between 14-18 years old will receive 4 sessions of anodic transcranial direct current stimulation. The results will be measured before and after the 4 sessions. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** This study will apply the anodic transcranial direct current stimulation over 20 children between 14-18 years old. The protocol that it will follow is the next one: 3 days to value the outcome measures, 4 days (1 sessions per day of 17 minutes and 30 seconds) to apply the protocol of anodic transcranial direct current stimulation (0,6 mA of intensity). It will use the EPTE V07 Bipolar System by IONCLINICS ®; 3 days to value the outcome measures studying the effects produced at the affected upper limb. Another evaluation will be realized 3 weeks after the last sessions of anodic transcranial direct current stimulation to know if the effects obtained last at medium-long term. **Name:** Anodic Transcranial Direct Current Stimulation **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** CHEQ is a questionnaire analyze the time it takes the children (between 6-18 years old) to do 29 functional activities; it also values the subjective experience of the children doing theses activities. It has a punctuation that goes from 1 to 4 (the maximum score is 348). If the score is higher, it means that the children's status is better. **Measure:** Changes in the timing that children use to complete the 29 items of the Children's Hand-Use Experience Questionnaire (CHEQ). **Time Frame:** Baseline, after 4 days (after de foruth sessions planned) and 3 weeks later #### Secondary Outcomes **Description:** Ashworth modified scale is a scale that values the spasticity. It has a punctuation that goes from 0 to 4. If the score is higher, it means that the spasticity is worse. **Measure:** Changes at the spasticity **Time Frame:** Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later **Description:** Fugl-Meyer scale for upper limb Is a scale that values the active movement, the sensibility, joints pain and passive movement of the upper limb. It has a punctuation that goes from 0 to 2 (the maximun score is 126). If the score is higher, it means that all it values are fine. **Measure:** Changes at the active movement **Time Frame:** Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later **Description:** Dynamometry is a test that values the hand strength. **Measure:** Changes at the manual strength **Time Frame:** Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later **Description:** Surface electromyography is a test that values the improvement in the recruitment of the motor units. **Measure:** Changes at the recruitment of the motor units. **Time Frame:** Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Children between 14-18 years old. * Children with spastic hemiparetic cerebral palsy diagnosis. * Children with a cognitive level high enough to understand and to do the activities to value them. * Children hemodynamically stable. * Children forming part of levels II-IV of the Manual Ability Classification System (MACS). Exclusion Criteria: * Children with defibrillator. * Children with pacemaker. * Children with cerebral stimulator. * Children with intracranial metallic implants. * Children with opened cranial after clambering. * Children that receive another treatment (pharmacological or physiotherapical) that could interfere or disrupt the results. * Another circumstance where the electrotherapy treatment is contraindicated. **Maximum Age:** 18 Years **Minimum Age:** 14 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** rovalemas@uma.es **Name:** Rocío Martín Valero, PhD **Phone:** 951952858 **Role:** CONTACT #### Locations **Location 1:** **City:** Málaga **Contacts:** ***Contact 1:*** - **Email:** rovalemas@uma.es - **Name:** Rocío Martín Valero, PhD - **Phone:** 951952858 - **Role:** CONTACT **Country:** Spain **Facility:** Rocío Martín Valero **Zip:** 29071 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### See Also Links **Label:** Mediline Plus **URL:** https://medlineplus.gov/spanish/ **Label:** Cerebral Palsy **URL:** https://www.ninds.nih.gov/health-information/disorders/cerebral-palsy **Label:** Brain Stimulation Therapies **URL:** https://www.nimh.nih.gov/health/topics/brain-stimulation-therapies/brain-stimulation-therapies **Label:** Noninvasive Brain Stimulation **URL:** https://www.ninds.nih.gov/news-events/directors-messages/all-directors-messages/noninvasive-brain-stimulation-applications-and-implications **Label:** Transcranial Direct Current Stimulation **URL:** https://www.ninds.nih.gov/health-information/clinical-trials/transcranial-direct-current-stimulation-improve-hand-movement-stroke-patients ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000001925 - Term: Brain Damage, Chronic - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5796 - Name: Cerebral Palsy - Relevance: HIGH - As Found: Cerebral Palsy - ID: M13157 - Name: Paralysis - Relevance: HIGH - As Found: Palsy - ID: M12085 - Name: Muscle Spasticity - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M5207 - Name: Brain Injuries - Relevance: LOW - As Found: Unknown - ID: M5202 - Name: Brain Damage, Chronic - 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: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010243 - Term: Paralysis - ID: D000002547 - Term: Cerebral Palsy ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438653 **Brief Title:** Reinterventions of Thoracic Endovascular Aortic Repair: a Retrospective Multicenter Cohort Study **Official Title:** Reinterventions of Thoracic Endovascular Aortic Repair: a Retrospective Multicenter Cohort Study #### Organization Study ID Info **ID:** 202312072RIND #### Organization **Class:** OTHER **Full Name:** National Taiwan University Hospital ### Status Module #### Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-20 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-18 **Type:** ACTUAL **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** National Taiwan University Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** We aimed to investigate the incidence of reinterventions in patients who underwent thoracic endovascular aortic repair (TEVAR) in multiple centers across Taiwan **Detailed Description:** This study analyzed the multicenter data set for TEVAR procedures performed between 2012 and 2017. Each patient's survival was verified with a query to the national data set. Student's t-test and χ2 analysis were used to compare continuous and categorical variables between the groups that required reintervention and those that did not, respectively. Kaplan-Meier methods were applied to analyze freedom from reintervention and survival rates.We aimed to investigate the incidence of reinterventions in patients who underwent thoracic endovascular aortic repair (TEVAR) in multiple centers across Taiwan ### Conditions Module **Conditions:** - Thoracic Endovascular Aortic Repair **Keywords:** - Thoracic endovascular aortic repair - Reinterventions ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 600 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: No-intervenyion **Label:** Thoracic endovascular aortic repair ### Interventions #### Intervention 1 **Arm Group Labels:** - Thoracic endovascular aortic repair **Description:** No-intervenyion **Name:** No-intervenyion **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The incidence of reinterventions in patients who underwent thoracic endovascular aortic repair (TEVAR) **Measure:** Reintervention **Time Frame:** 7 years #### Secondary Outcomes **Measure:** Mortality **Time Frame:** 7 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients who underwent thoracic endovascular aortic repair (TEVAR) Exclusion Criteria: * No thoracic endovascular aortic repair (TEVAR) **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients who underwent thoracic endovascular aortic repair (TEVAR) in multiple centers across Taiwan. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** chanchihyang@gmail.com **Name:** Chih-Yang Chan, phd **Phone:** +88672651147 **Role:** CONTACT #### Locations **Location 1:** **City:** Taipei **Contacts:** ***Contact 1:*** - **Name:** Chih-Yang Chan, MD Phd - **Role:** CONTACT **Country:** Taiwan **Facility:** National Taiwan University Hospital **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** National Taiwan University Hospital **Name:** Chih-Yang Chan, phd **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Ancestors - ID: D000094665 - Term: Dissection, Blood Vessel - ID: D000000783 - Term: Aneurysm - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000094683 - Term: Acute Aortic Syndrome - ID: D000001018 - Term: Aortic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4114 - Name: Aortic Dissection - Relevance: HIGH - As Found: Thoracic - ID: M3081 - Name: Dissection, Blood Vessel - Relevance: LOW - As Found: Unknown - ID: M4113 - Name: Aneurysm - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M3085 - Name: Acute Aortic Syndrome - Relevance: LOW - As Found: Unknown - ID: M4334 - Name: Aortic Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000784 - Term: Aortic Dissection ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438640 **Brief Title:** Evaluating a Strategy to Improve Pre-Anesthesia Care Discussions (My Anesthesia Choice-Hip Fracture) **Official Title:** Implementation and Evaluation of a Strategy to Improve Pre-Anesthesia Care Discussions (My Anesthesia Choice-Hip Fracture) #### Organization Study ID Info **ID:** 855203 #### Organization **Class:** OTHER **Full Name:** University of Pennsylvania ### Status Module #### Completion Date **Date:** 2028-05-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-05-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Wake Forest University Health Sciences **Class:** OTHER **Name:** University of Florida **Class:** OTHER **Name:** Dartmouth-Hitchcock Medical Center **Class:** OTHER **Name:** Henry Ford Health System **Class:** OTHER **Name:** The Cleveland Clinic **Class:** OTHER **Name:** Dartmouth College **Class:** OTHER **Name:** Washington University School of Medicine #### Lead Sponsor **Class:** OTHER **Name:** University of Pennsylvania #### 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 this study is to assess the implementation process for and the effectiveness of a quality improvement (QI) strategy to increase shared decision-making around anesthesia options for hip fracture surgery at 6 US hospitals. The QI strategy is to be facilitated by a clinician-administered 1-page bedside conversation aid designed to improve the quality of physician-patient communication, paired with brief clinician training. The evaluation will occur via a stepped wedge, cluster randomized trial to be carried out over a period of 27 months. **Detailed Description:** The objective of this study is to assess the implementation process for and the effectiveness of a quality improvement (QI) strategy to increase shared decision-making around anesthesia options for hip fracture surgery at 6 US hospitals. The QI strategy is to be facilitated by a clinician-administered 1-page bedside conversation aid designed to improve the quality of physician-patient communication, paired with brief clinician training. The evaluation will occur via a stepped wedge, cluster randomized trial to be carried out over a period of 27 months. Activities at each site will be divided into three phases: Pre-Implementation; Active Implementation; and Sustainment. Data collection will occur across all study phases at each site, although specific data elements collected will vary across phases. To facilitate evaluation, sites will be randomly assigned to one of three possible timing sequences (A, B, C) for project implementation (2 sites/sequence). The duration of the active implementation phase will be the same for each sequence (12 months); however, the duration of pre-implementation and sustainment phases will vary across sequences. During the pre-implementation phase, data collection on selected outcome variables will occur but no interventions will be delivered. During the implementation phase, site clinicians will undergo training in use of the My Anesthesia Choice-HF tool and the tool will be made available for use in clinical areas with eligible patients. Data collection on key outcomes will continue over this period, and clinicians will receive reminders to encourage tool use. During Sustainment, the tool will remain available for use and outcomes will continue to be measured to assess sustainment of the intervention over time. ### Conditions Module **Conditions:** - Hip Fractures - Femoral Neck Fractures - Intertrochanteric Fractures - Subtrochanteric Fractures **Keywords:** - hip fracture - femoral neck - intertrochanteric - subtrochanteric - fracture - anesthesia - observational study - survey - shared decision making - My Anesthesia Choice - MAC-HF ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SEQUENTIAL **Intervention Model Description:** Stepped Wedge Cluster Randomized Trial ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 3548 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Usual care will be delivered at each site during the pre-intervention phase. Patients treated in this arm will undergo pre-anesthesia care discussions as per existing clinical routine at each site. **Label:** Usual Care **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** During the intervention and sustainment phases, site clinicians will receive standardized in-personal or virtual training on shared decision making theory and approaches. The My Anesthesia Choice-HF tool will be made available for use during preoperative conversations. Clinicians will receive encouragement to use the tool on study-eligible patients based on their assessment of clinical appropriateness. **Intervention Names:** - Behavioral: My Anesthesia Choice-HF Model **Label:** My Anesthesia Choice- HF **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - My Anesthesia Choice- HF **Description:** Brief clinician training on shared decision making, paired with provision of a 1-page tabular format conversation aid listing answers to frequently asked questions regarding common anesthesia options for hip fracture surgery (spinal anesthesia; general anesthesia) **Name:** My Anesthesia Choice-HF Model **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** The fraction of patients reporting decisional conflict about anesthesia pre-implementation versus active implementation periods will be assessed via the 4-item SURE measure. **Measure:** Decisional conflict **Time Frame:** Postoperative day 0-3 **Description:** Patient-reported knowledge about anesthesia options during the pre-implementation versus active implementation periods will be assessed by a 6-item brief knowledge evaluation **Measure:** Knowledge regarding anesthesia options **Time Frame:** Postoperative day 0-3 **Description:** Patient satisfaction with anesthesia care during the pre-implementation versus active implementation periods will be assessed by a single-item "willingness to recommend to friends and family" satisfaction measure. **Measure:** Willingness to recommend anesthesia type **Time Frame:** Postoperative day 0-3 **Description:** The fraction of patients receiving general versus spinal anesthesia will be compared during the pre-implementation versus active implementation periods. **Measure:** Anesthesia type received **Time Frame:** Day of surgery **Description:** The fraction of patients who are able to ambulate independently (i.e. without human assistance) at first clinic follow up between 30 and 90 days after surgery will be compared during the pre-implementation versus implementation periods. **Measure:** Recovery of ambulation **Time Frame:** Postoperative day 30 to 90 **Description:** Fidelity of implementation to recommended best practices during active implementation and sustainment phases, assessed via the 9-item UPFRONT Fidelity Assessment. This item will be assessed on approximately 10% of patients treated in each phase **Measure:** Fidelity of intervention delivery **Time Frame:** Day of surgery **Description:** The percentage of eligible patients receiving the strategy during the sustainment phase **Measure:** Sustainment of intervention **Time Frame:** Day of surgery **Description:** Study clinicians' perceptions regarding sustainability of the intervention will be assessed during the implementation and sustainment phases via the 23-item NoMAD sustainability assessment. **Measure:** Perceived sustainability of the intervention **Time Frame:** Study months 12-27 #### Primary Outcomes **Description:** Reach of the intervention will be assessed as the rate of use of the conversation aid during the active implementation phase at each site among eligible patients during the pre-anesthesia evaluation. Data will be collected during the implementation phase at each site. **Measure:** Intervention reach (primary implementation outcome) **Time Frame:** Day of surgery **Description:** SDMP is a 4-item measure of shared decision making; this will be assessed on eligible patients during the pre-implementation and implementation phases of the study to allow for comparison of scores among eligible patients treated in the two periods **Measure:** Shared Decision-Making Process scale score (SDMP; primary effectiveness outcome) **Time Frame:** Postoperative day 0-3 #### Secondary Outcomes **Description:** A 3-item measure of shared decision making; this will be assessed on eligible patients during the pre-implementation and implementation phases of the study to allow for comparison of scores among eligible patients treated in the two periods **Measure:** CollaboRATE shared decision making scale score (secondary effectiveness outcome). **Time Frame:** Postoperative day 0-3 ### Eligibility Module **Eligibility Criteria:** Inclusion: Age 50 and older Planned surgery to treat a hip fracture Exclusion: Contraindication to spinal anesthesia: current anticoagulant therapy or coagulopathy Contraindication to spinal anesthesia: critical aortic stenosis Contraindication to spinal anesthesia: skin infection over the lumbar spine **Minimum Age:** 50 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** neumanm@pennmedicine.upenn.edu **Name:** Mark Neuman, MD **Phone:** 215-746-7468 **Role:** CONTACT **Contact 2:** **Email:** james.baraldi@pennmedicine.upenn.edu **Name:** James Baraldi **Role:** CONTACT #### Locations **Location 1:** **City:** Gainesville **Contacts:** ***Contact 1:*** - **Name:** Joshua Sappenfield - **Role:** CONTACT ***Contact 2:*** - **Name:** Joshua Sapenfield, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of Florida Gainesville **State:** Florida **Zip:** 32608 **Location 2:** **City:** Detroit **Contacts:** ***Contact 1:*** - **Name:** Carlos Guerra Londono - **Role:** CONTACT ***Contact 2:*** - **Name:** Carlos Guerra Londono, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Henry Ford Hospital **State:** Michigan **Zip:** 48202 **Location 3:** **City:** Lebanon **Contacts:** ***Contact 1:*** - **Name:** Stacie G Deiner - **Role:** CONTACT **Country:** United States **Facility:** Dartmouth Hitchcock Medical Center **State:** New Hampshire **Zip:** 03766 **Location 4:** **City:** Winston-Salem **Contacts:** ***Contact 1:*** - **Name:** Lynette Harris, BSN - **Role:** CONTACT ***Contact 2:*** - **Name:** Christopher Edwards, MD - **Role:** SUB_INVESTIGATOR **Country:** United States **Facility:** Wake Forest University Baptist Medical Center **State:** North Carolina **Zip:** 27157 **Location 5:** **City:** Cleveland **Contacts:** ***Contact 1:*** - **Name:** Sabry Ayad - **Role:** CONTACT ***Contact 2:*** - **Name:** Sabry Ayad, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Cleveland Clinic-Fairview **State:** Ohio **Zip:** 44195 **Location 6:** **City:** Philadelphia **Contacts:** ***Contact 1:*** - **Name:** James Baraldi, PhD - **Role:** CONTACT ***Contact 2:*** - **Name:** Mark Neuman, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Veena Graff, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Penn Presbyterian Medical Center **State:** Pennsylvania **Zip:** 19104 #### Overall Officials **Official 1:** **Affiliation:** University of Pennsylvania **Name:** Mark Neuman, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014947 - Term: Wounds and Injuries - ID: D000005264 - Term: Femoral Fractures - ID: D000025981 - Term: Hip Injuries - ID: D000007869 - Term: Leg Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M26370 - Name: Fractures, Bone - Relevance: HIGH - As Found: Fracture - ID: M9696 - Name: Hip Fractures - Relevance: HIGH - As Found: Hip Fracture - ID: M8403 - Name: Femoral Neck Fractures - Relevance: HIGH - As Found: Femoral Neck Fractures - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M8402 - Name: Femoral Fractures - Relevance: LOW - As Found: Unknown - ID: M23105 - Name: Hip Injuries - Relevance: LOW - As Found: Unknown - ID: M10881 - Name: Leg Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000050723 - Term: Fractures, Bone - ID: D000006620 - Term: Hip Fractures - ID: D000005265 - Term: Femoral Neck Fractures ### Intervention Browse Module - Ancestors - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: HIGH - As Found: Function ### Intervention Browse Module - Meshes - ID: D000000777 - Term: Anesthetics ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438627 **Brief Title:** Efficacy and Safety of TPC+Apatinib+Camrelizumab vs GP+ Camrelizumab for High-Risk Nasopharyngeal Carcinoma: A Phase 3 Trial **Official Title:** Efficacy and Safety of Nab-Paclitaxel, Cisplatin, and Capecitabine Chemotherapy Combined With Apatinib and Camrelizumab vs Gemcitabine, Cisplatin Combined With Camrelizumab for Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in High-Risk Nasopharyngeal Carcinoma: A Prospective, Controlled, Open-Label, Multicenter Phase 3 Clinical Trial #### Organization Study ID Info **ID:** SYSKY-2024-267-02 #### Organization **Class:** OTHER **Full Name:** Sun Yat-sen University ### Status Module #### Completion Date **Date:** 2029-05-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-30 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-24 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** XIANG YANQUN #### Responsible Party **Investigator Affiliation:** Sun Yat-sen University **Investigator Full Name:** XIANG YANQUN **Investigator Title:** Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study aims to evaluate the efficacy and safety of the TPC regimen (nab-paclitaxel, cisplatin, and capecitabine) combined with apatinib and camrelizumab versus the GP regimen (gemcitabine and cisplatin) combined with camrelizumab for the treatment of high-risk regionally advanced nasopharyngeal carcinoma with a high risk of distant metastasis. The evaluation will be conducted through a prospective, controlled, open-label, multicenter phase 3 clinical trial in areas with high incidence of nasopharyngeal carcinoma. **Detailed Description:** IMPORTANCE: Safe and effective therapies for untreated, advanced locally advanced nasopharyngeal carcinoma remain an unmet need. OBJECTIVE:This study aims to evaluate the efficacy and safety of the TPC regimen (nab-paclitaxel, cisplatin, and capecitabine) combined with apatinib and camrelizumab versus the GP regimen (gemcitabine and cisplatin) combined with camrelizumab for the treatment of high-risk regionally advanced nasopharyngeal carcinoma with a high risk of distant metastasis. The evaluation will be conducted through a prospective, controlled, open-label, multicenter phase 3 clinical trial in areas with high incidence of nasopharyngeal carcinoma. ### Conditions Module **Conditions:** - Nasopharyngeal Carcinoma ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 164 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Radiation: IMRT Drug: Nab-Paclitaxel, Cisplatin, and Capecitabine Chemotherapy Combined With Apatinib and Camrelizumab (Induction chemotherapy) **Intervention Names:** - Drug: TPC combined with Apatinib and Camrelizumab **Label:** TPC+Apatinib+Camrelizumab **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Radiation: IMRT Drug: Gemcitabine, Cisplatin Combined With Camrelizumab (Induction chemotherapy) **Intervention Names:** - Drug: GP Combined With Camrelizumab **Label:** GP+ Camrelizumab **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - TPC+Apatinib+Camrelizumab **Description:** Nab-Paclitaxel, Cisplatin, and Capecitabine Chemotherapy Combined With Apatinib and Camrelizumab **Name:** TPC combined with Apatinib and Camrelizumab **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - GP+ Camrelizumab **Description:** Gemcitabine, Cisplatin regimen Combined With Camrelizumab **Name:** GP Combined With Camrelizumab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** 3-years failure-free survival rate **Measure:** 3-years FFS **Time Frame:** up to 3 years #### Secondary Outcomes **Description:** Distant metastasis-free survival rate **Measure:** DMFS **Time Frame:** up to 3 years **Description:** Overall survival rate **Measure:** OS **Time Frame:** up to 3 years **Description:** locoregional progression-free survival rate **Measure:** LRFS **Time Frame:** up to 3 years **Description:** Objective response rate **Measure:** ORR **Time Frame:** up to 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Pathologically confirmed WHO type II or III; 2. Staging TanyN3M0 (UICC/AJCC 8th edition); 3. Treatment-naive patients with no history of other malignancies; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; 5. Age 18-65 years; 6. Neutrophils ≥1.5×10\^9/L, platelets ≥100×10\^9/L, hemoglobin ≥90 g/L, transaminases \<2.5 times the upper limit of normal, total bilirubin \<1.5 times the upper limit of normal, creatinine \<1.5 times the upper limit of normal; activated partial thromboplastin time and international normalized ratio \<1.5 times the upper limit of normal; 7. Signed informed consent form. Exclusion Criteria: 1. Known or suspected allergy to the study drugs, or pregnant/perinatal women; 2. Inability to comply with regular follow-up due to psychological, social, familial, or geographical reasons; 3. Severe dysfunction of critical organs such as the heart, lungs, liver, or kidneys (e.g., decompensated heart, lung, renal, or liver failure) that precludes tolerance to chemoradiotherapy; 4. Severe uncontrolled infection or internal medical disease; 5. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); untreated active hepatitis (hepatitis B defined as HBV-DNA ≥500 IU/ml, exclusion if normal liver function and on antiviral medication for more than one week; hepatitis C defined as HCV-RNA above the lower limit of detection) or coinfection with hepatitis B and C; 6. Factors affecting drug administration, distribution, metabolism, or excretion such as psychiatric disorders, central nervous system abnormalities, chronic diarrhea, ascites, or pleural effusion; 7. Poorly controlled hypertension despite antihypertensive treatment (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg); 8. Long-term use of immunosuppressants post-organ transplantation; 9. Known history of substance abuse or drug addiction; 10. History of other malignancies prior to enrollment; 11. Presence of other severe physical or mental illnesses or abnormal laboratory findings that may increase the risk of study participation, interfere with study results, or deemed unsuitable for participation by the investigator. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** xiangyq@syscc.org.cn **Name:** Yanqun Xiang **Phone:** 18666096623 **Role:** CONTACT **Contact 2:** **Email:** liugy0109@163.com **Name:** Guoying Liu **Phone:** 18127919832 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** SunYat-sen U **Name:** Yanqun Xiang **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009303 - Term: Nasopharyngeal Neoplasms - ID: D000010610 - Term: Pharyngeal Neoplasms - ID: D000010039 - Term: Otorhinolaryngologic Neoplasms - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009302 - Term: Nasopharyngeal Diseases - ID: D000010608 - Term: Pharyngeal Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000010038 - Term: Otorhinolaryngologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M1730 - Name: Nasopharyngeal Carcinoma - Relevance: HIGH - As Found: Nasopharyngeal 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: M12254 - Name: Nasopharyngeal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M13517 - Name: Pharyngeal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12962 - Name: Otorhinolaryngologic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12253 - Name: Nasopharyngeal Diseases - Relevance: LOW - As Found: Unknown - ID: M13515 - Name: Pharyngeal Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M12961 - Name: Otorhinolaryngologic Diseases - Relevance: LOW - As Found: Unknown - ID: T4047 - Name: Nasopharyngeal Carcinoma - Relevance: HIGH - As Found: Nasopharyngeal Carcinoma ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000077274 - Term: Nasopharyngeal Carcinoma ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000047428 - Term: Protein Kinase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M19537 - Name: Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M6182 - Name: Cisplatin - Relevance: LOW - As Found: Unknown - ID: M2985 - Name: Gemcitabine - Relevance: LOW - As Found: Unknown - ID: M377 - Name: Capecitabine - Relevance: LOW - As Found: Unknown - ID: M288166 - Name: Apatinib - Relevance: HIGH - As Found: HER2 - ID: M25820 - Name: Protein Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000553458 - Term: Apatinib ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438614 **Acronym:** NICE **Brief Title:** A Study Of Naxitamab , Granulocyte Macrophage Colony Stimulating Factor For Patients With Relapsed /Refractory , Soft Tissue or Anti GD2 Immunotherapy Refractory Neuroblastoma **Official Title:** A Phase II Single Center Study Of Naxitamab , Granulocyte Macrophage Colony Stimulating Factor (GM CSF and Ifosfamide Carboplatin Etoposide) For Patients With Relapsed Refractory , Soft Tissue or Anti GD2 Immunotherapy Refractory Neuroblastoma #### Organization Study ID Info **ID:** HSJD HR NB.2 2019 #### Organization **Class:** OTHER **Full Name:** Fundació Sant Joan de Déu ### Status Module #### Completion Date **Date:** 2023-10-24 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-30 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-07-20 **Type:** ACTUAL #### Start Date **Date:** 2020-08-20 **Type:** ACTUAL **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-03-21 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Fundació Sant Joan de Déu #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to evaluate safety and efficacy of naxitamab, granulocyte macrophage Colony Stimulating Factor (GM CSF) and Isofosfamide/Carboplatin/Etoposide (NICE) for Patients With Relapsed /Refractory, soft tissue or anti GD2 immunotherapy refractory Neuroblastoma **Detailed Description:** The anti-GD2 monoclonal antibody Naxitamab (also known as hu3F8) in combination with macrophage colony-stimulating factor (GM-CSF) is currently under pivotal phase 3 investigation for the treatment of High-Risk Neuroblastoma Patients with Primary or Secondary Refractory Osteomedullary Disease. A subset of patients with high-risk, resistant disease, i.e., relapsed or refractory Neuroblastoma with soft tissue involvement as measured by 123I-MIBG, 18F-FDG avid or measurable CT/MRI tumors outside of the bone marrow, or disease refractory to Naxitamab in combination with GM-CSF has shown significant response rates to a chemoimmunotherapy combination of Naxitamab, GM-CSF, irinotecan and temozolomide (HITS- Hu3F8, irinotecan, temozolomide and sargramostim) (NCT03189706). Treatment is administered on an outpatient basis and toxicities include those expected from I/T (myelosuppression and diarrhea) as well as pain and hypertension expected with Naxitamab. No other greater than grade 2 related toxicities occurred in this study (n=46). Early responses, assessed after 2 cycles, were documented in 18 (39%) patients and here complete (n = 9), partial (n = 8), and mixed (n = 1) and 13 patients had stable disease. Responses were achieved in refractory (3/7;43%) and progressive disease (15/39;38%) subgroups, in patients who had previously received I/T (12/34;35%) and/or anti-GD2 MoAb (14/36;39%), and in soft tissue (6/22; 27%) MIBG-avid skeletal sites (20/36;56%) and on bone marrow histology (9/12;75%). While encouraging, new strategies are warranted to further treat resistant disease. A high-dose combination of ifosfamide, carboplatin, and etoposide (ICE) has activity against Neuroblastoma without cross-resistance to widely used chemotherapy regimens. Through compassionate use, 4 patients with progression of disease or refractory disease after HITS therapy, have been further treated with two cycles of a combination of naxitamab, Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) and ifosfamide/Carboplatin/Etoposide (NICE). The first patient showed a complete response. Toxicity included G2 prolonged aplasia and G3 hypertension, both expected from the chemotherapy agents and hu3F8. One patient progressed after the 2 cycles and the other 2 showed stable disease, according to the revised (2017) INRC criteria. In this formal trial, we will investigate whether the combination of Naxitamab and GM-CSF with ICE has a synergistic treatment effect in relapsed or refractory disease. The safety and efficacy of NICE (Naxitamab, Ifosfamide/Carboplatin/Etoposide) in patients that have not achieved complete remission with HITS chemo-immunotherapy will be assessed. ### Conditions Module **Conditions:** - Refractory Neuroblastoma - Soft Tissue Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Subjects will receive 2 cycles of HITS. Each cycle of HITS (4 doses of hu3F8, 5 doses of irinotecan and temozolomide and 5 doses of GM-CSF). Patients with CR after 2 or 4 cycles of HITS will receive 5 cycles of Naxitamab + GM-CSF cycles. Patients that do not have an objective response (CR/PR) will receive NICE within 3 weeks from last dose. Each cycle of NICE consists of 4 doses of hu3F8, 5 doses of GM-CSF, 1 dose of carboplatin, and 3 doses each of ifosfamide and etoposide. Patients with less than CR response (PR/SD) will receive 2 more cycles of NICE and evaluated after 4th cycle. Patients with no objective response at these timepoints will be removed from the study. Patients with CR will receive 5 cycles of Naxitamab consolidation cycles consisting of GM-CSF250mcg/m2/day SC administered from day -4 to day 0 and GM-CSF500mcg/m2/day SC administered from day 1 to day 5. Three doses of hu3F83 mg/kg IVwill be administrated, specifically on days 1, 3 and 5. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 47 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Treatment involves 2 cycles of HITS: hu3F8, irinotecan, temozolomide, and GM-CSF. Irinotecan and temozolomide are given for 5 days, and hu3F8 and GM-CSF on specific days. Following this, 5 cycles of Naxitamab + GM-CSF are administered. Patients without a response receive NICE: hu3F8, GM-CSF, carboplatin, ifosfamide, and etoposide for 4 cycles. Patients with a complete response (CR) move to Naxitamab consolidation (5 cycles). This involves GM-CSF before and after, and hu3F8 on days 1, 3, and 5. Those with less than CR undergo 2 more NICE cycles, evaluated after the 4th. Lack of response leads to removal from the study. **Intervention Names:** - Drug: HITS - Drug: Naxitamab + GM-CSF cycles - Drug: NICE **Label:** Arm 1 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Arm 1 **Description:** Four doses of hu3F8, five doses each of irinotecan and temozolomide and five doses of GM-CSF. Irinotecan 50mg/m2/day IV will be administered from day 1-5concurrently with temozolomide 150mg/m2/day orally. Hu3F8 2.25mg/kg IV will be administered on days 2, 4, 9and11. GM-CSF 250mcg/m2/day SC will be administered on days 7-11 **Name:** HITS **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Arm 1 **Description:** Patients that achieve CR after 2 or 4 cycles of HITS will move on to 5 cycles of Naxitamab + GM-CSF cycles. **Name:** Naxitamab + GM-CSF cycles **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Arm 1 **Description:** Patients that do not have an objective response (CR/PR) will receive NICE within 3 weeks from last dose. Each cycle of NICE consists of four doses of hu3F8, five doses of GM-CSF, one dose of carboplatin, and 3 doses each of ifosfamide and etoposide (table 2). Hu3F8 2.25mg/kg IV will be administered on days 2, 4, 9and 11. GM-CSF 250mcg/m2/day SC will be administered on days 7-11. Ifosfamide 1.5 gr/m2/day IV will be administered from day 1-3 concurrently with etoposide 100 mg/m2/day IV. Carboplatin 400 mg/m2/day IV will be administered on day 1 **Name:** NICE **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The safety and tolerability of the treatment will be determined by means of type, incidence, severity, timing, seriousness, and relatedness of reported AEs, physical examinations, and laboratory tests. Toxicity will be graded and tabulated by the NCI CTCA E v 5 .0 **Measure:** Number of Participants with Serious and Non-Serious Adverse Events **Time Frame:** 14 months after ICF signature **Description:** Best Overall Response is defined as the best response recorded from the start of the study treatment **Measure:** Best Overall Response (at the end of HITS treatment) **Time Frame:** From first day of treatment with HITS until completion of HITS (39 days). **Description:** The number and proportion of patients with CR as Best Overall Response at the end of HITS treatment **Measure:** Best Overall Response of Complete Response (CR) (at the end of HITS treatment) **Time Frame:** From first day of treatment with HITS until completion of HITS(39 days). **Description:** Objective Response Rate is defined as the proportion of patients with Best Overall Response of CR (complete response) or PR (partial response). **Measure:** Objective Response Rate (at the end of HITS treatment) **Time Frame:** From first day of treatment with HITS until completion of HITS (39 days). **Description:** Clinical Benefit Rate is defined as the proportion of patients with Best Overall Response of CR (complete response) or PR (partial response) or SD (stable disease) ≥ 24 w **Measure:** Clinical Benefit Rate (at the end of HITS treatment) **Time Frame:** From first day of treatment with HITS until completion of HITS (39 days). **Description:** Best Overall Response is defined as the best response recorded from the start of the study treatment **Measure:** Best Overall Response (at the end of NICE treatment) **Time Frame:** From first day of treatment with NICE until completion of NICE (39 days). **Description:** The number and proportion of patients with CR as Best Overall Response at the end of NICE treatment **Measure:** Best Overall Response of Complete Response (CR) (at the end of NICE treatment) **Time Frame:** From first day of treatment with NICE until completion of NICE (39 days). **Description:** Objective Response Rate is defined as the proportion of patients with Best Overall Response of CR (complete response) or PR (partial response). **Measure:** Objective Response Rate (at the end of NICE treatment) **Time Frame:** From first day of treatment with NICE until completion of NICE (39 days). **Description:** Clinical Benefit Rate is defined as the proportion of patients with Best Overall Response of CR (complete response) or PR (partial response) or SD (stable disease) ≥ 24 w **Measure:** Clinical Benefit Rate (at the end of NICE treatment) **Time Frame:** From first day of treatment with NICE until completion of NICE (39 days). #### Secondary Outcomes **Measure:** To evaluate serum cytokines in patients receiving NICE **Time Frame:** From first day of treatment with NICE, until day 11 post administration. **Description:** Minimal residual disease for NB will be evaluated using the Revised International NB Response Criteria (JCO August 1, 2017) **Measure:** To measure MRD after HITS **Time Frame:** From first day of treatment with HITS until completion of HITS (39 days). **Description:** Minimal residual disease for NB will be evaluated using the Revised International NB Response Criteria (JCO August 1, 2017) **Measure:** To measure MRD after NICE **Time Frame:** From first day of treatment with NICE until completion of NICE (39 days). ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Diagnosis of NB as defined per INRC as 1. histopathology of tumor biopsy, or 2. BM aspirate or biopsy indicative of NB by histology plus high blood or urine catecholamine metabolite levels or MYCN amplification, or 3. FDG, MIBG avid lesion(s) 2. High-risk NB as defined as any of the following: 1. Stage 4 with MYCN amplification 2. Stage 4 without MYC amplification \>1.5 y of age 3. Stage 3 with MYCN amplification 3. Relapsed/refractory Neuroblastoma with 1. Evidence of soft tissue disease or 2. Progessive disease/incomplete response/relapsed to previous treatment with Naxitamab plus GM-CSF 4. Prior treatment with murine and hu3F8 is allowed 5. Prior treatment with irinotecan or temozolomide or ICE is permitted 6. Evaluable (microscopic marrow metastasis, elevated tumor markers, positive MIBG or PET scans) or measurable (CT, MRI) disease documented after completion of prior systemic therapy 7. Age ≥18 months 8. Acceptable hematological status defined as: 1. Hemoglobin ≥8 g/dL (5.0 mmol/L) 2. White blood cell count ≥1000/μL 3. ANC ≥500/μL 4. Platelet count ≥50,000/μL 9. Acceptable liver function defined as: 1. ALT and AST ≤5 times ULN 2. Bilirubin ≤1.5 x ULN 10. Acceptable kidney function defined as: a. eGFR \>60 mL/min/1.73 m2 calculated by the 2009 revised Bedside Schwartz Equation 11. Written informed consent from legal guardian(s) and/or patient in accordance with local regulations. Children must provide assent as required by local regulations (≥ 12 years old). Exclusion Criteria: 1. Existing major organ dysfunction \> grade 2, with the exception of hearing loss and hematologic toxicity (defined as suppression of all subtypes of WBCs, RBCs, and platelets). 2. Active life-threatening infection. 3. Pregnant women or women who are breast-feeding. 4. Inability to comply with protocol requirements, including genetic studies. 5. History of allergy to GM-CSF ≥ G4 (CTCAE) or does not respond to treatment. 6. ANC \< 500/uL . 7. Platelet count \<50,000/uL. 8. Patients with relapsed/refractory Neuroblastoma with solely bone marrow/bone involvement. Only patients with B/BM compartiment disease who show progressive disease/incomplete response/relapsed to previous treatment with Naxitamab plus GM-CSF may be eligible (inclusion critèrium #3). **Minimum Age:** 18 Months **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Esplugues De Llobregat **Country:** Spain **Facility:** Hospital Sant Joan de Déu **State:** Barcelona **Zip:** 08950 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000018241 - Term: Neuroectodermal Tumors, Primitive, Peripheral - ID: D000018242 - Term: Neuroectodermal Tumors, Primitive - ID: D000018302 - Term: Neoplasms, Neuroepithelial - ID: D000017599 - Term: Neuroectodermal Tumors - ID: D000009373 - Term: Neoplasms, Germ Cell and Embryonal - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009380 - Term: Neoplasms, Nerve Tissue - ID: D000018204 - Term: Neoplasms, Connective and Soft Tissue ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15327 - Name: Sarcoma - Relevance: HIGH - As Found: Soft Tissue Cancer - ID: M12391 - Name: Neuroblastoma - Relevance: HIGH - As Found: Neuroblastoma - ID: M20387 - Name: Neuroectodermal Tumors, Primitive, Peripheral - Relevance: LOW - As Found: Unknown - ID: M19845 - Name: Neuroectodermal Tumors - Relevance: LOW - As Found: Unknown - ID: M20388 - Name: Neuroectodermal Tumors, Primitive - Relevance: LOW - As Found: Unknown - ID: M20446 - Name: Neoplasms, Neuroepithelial - Relevance: LOW - As Found: Unknown - ID: M12318 - Name: Neoplasms, Germ Cell and Embryonal - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12325 - Name: Neoplasms, Nerve Tissue - Relevance: LOW - As Found: Unknown - ID: M20350 - Name: Neoplasms, Connective and Soft Tissue - Relevance: LOW - As Found: Unknown - ID: T4085 - Name: Neuroblastoma - Relevance: HIGH - As Found: Neuroblastoma - ID: T2453 - Name: Gaucher Disease Type 2 - Relevance: LOW - As Found: Unknown - ID: T5284 - Name: Soft Tissue Sarcoma - Relevance: LOW - As Found: Unknown - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009447 - Term: Neuroblastoma - ID: D000012509 - Term: Sarcoma ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M18650 - Name: Carboplatin - Relevance: LOW - As Found: Unknown - ID: M1692 - Name: Temozolomide - Relevance: LOW - As Found: Unknown - ID: M1671 - Name: Irinotecan - Relevance: LOW - As Found: Unknown - ID: M8191 - Name: Etoposide - Relevance: LOW - As Found: Unknown - ID: M257633 - Name: Molgramostim - Relevance: LOW - As Found: Unknown - ID: M219218 - Name: Sargramostim - Relevance: LOW - As Found: Unknown - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: M10117 - Name: Ifosfamide - Relevance: LOW - As Found: Unknown - ID: M341643 - Name: Etoposide phosphate - Relevance: LOW - As Found: Unknown - ID: M230811 - Name: Isophosphamide mustard - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438601 **Brief Title:** A Clinical Comparison of Two Multifocal Toric Soft Contact Lenses **Official Title:** A Clinical Comparison of Two Multifocal Toric Soft Contact Lenses #### Organization Study ID Info **ID:** EX-MKTG-159 #### Organization **Class:** INDUSTRY **Full Name:** Coopervision, Inc. ### Status Module #### Completion Date **Date:** 2024-07-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-30 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-07-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-25 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-24 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Coopervision, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study aims to compare the short-term clinical performance of the two study contact lenses. **Detailed Description:** The aim of this study is to evaluate the short-term clinical performance of two multifocal toric soft contact lenses after 15 minutes of daily wear each. ### Conditions Module **Conditions:** - Astigmatism - Presbyopia ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All participants will wear lens A for 15 minutes (Period 1). **Intervention Names:** - Device: Lens A (omafilcon A) **Label:** Lens A (omafilcon A) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** All participants will wear lens B for 15 minutes (Period 2). **Intervention Names:** - Device: Lens B (comfilcon A) **Label:** Lens B (comfilcon A) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Lens A (omafilcon A) **Description:** 15 minutes of daily wear **Name:** Lens A (omafilcon A) **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Lens B (comfilcon A) **Description:** 15 minutes of daily wear **Name:** Lens B (comfilcon A) **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Subjective Distance Vision will be measured on a scale from 0-100 (Where 0= Extremely poor. Intolerable. Lenses cannot be worn. 100= Excellent. Unaware of any visual loss). **Measure:** Subjective Distance Vision **Time Frame:** At the end of 15 minutes of daily wear ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. They are aged 35 years or over and have capacity to volunteer. 2. They understand their rights as a subject and are willing to sign a Statement of Informed Consent. 3. They are willing and able to follow the protocol. 4. They agree not to participate in other clinical research for the duration of this study. 5. They are currently wearing soft contact lenses or have done so within the past 12 months. 6. They have a spherical prescription between +10.00 and -10.00DS inclusive, (based on the ocular refraction). 7. They have astigmatism of between -0.75 and -5.75DC (based on the ocular refraction) in each eye. 8. They have a reading addition component to their spectacle refraction of between +0.75 and +2.50DS. 9. They can be satisfactorily fitted with the study lenses. 10. They own a wearable pair of spectacles. Exclusion Criteria: 1. They have an ocular disorder which would normally contraindicate contact lens wear. 2. They have a systemic disorder which would normally contra-indicate contact lens wear. 3. They are using any topical medications such as eye drops or ointment. 4. They have had cataract surgery. 5. They have had corneal refractive surgery. 6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. 7. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. 8. They have eye or health conditions including immunosuppressive or infectious diseases which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction. 9. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study. **Minimum Age:** 35 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Manchester **Country:** United Kingdom **Facility:** The University of Manchester #### Overall Officials **Official 1:** **Affiliation:** Eurolens Research **Name:** Carole Maldonado-Codina, PhD,MCOptom **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012030 - Term: Refractive Errors - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4558 - Name: Astigmatism - Relevance: HIGH - As Found: Astigmatism - ID: M14179 - Name: Presbyopia - Relevance: HIGH - As Found: Presbyopia - ID: M14872 - Name: Refractive Errors - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001251 - Term: Astigmatism - ID: D000011305 - Term: Presbyopia ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438588 **Brief Title:** Fasting Mimicking Diet for Reducing Immune Related Adverse Events for Cancer Patients on Immune Checkpoint Inhibitors, FMD-ICI Trial **Official Title:** Effect of Fasting Mimicking Diet (FMD) on Immune Related Adverse Events for Cancer Patients on Immune Checkpoint Inhibitors: The FMD-ICI Feasibility Pilot Study #### Organization Study ID Info **ID:** 20-012936 #### Organization **Class:** OTHER **Full Name:** Mayo Clinic #### Secondary ID Infos **Domain:** CTRP (Clinical Trial Reporting Program) **ID:** NCI-2024-03515 **Type:** REGISTRY **Domain:** Mayo Clinic Institutional Review Board **ID:** 20-012936 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2027-03-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-03-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-06 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-31 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mayo Clinic #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This clinical trial assesses an effective and translatable care model to understand and reduce the adverse effects that cancer patients experience during their treatment therapies and thereby enhance their well-being and quality of life. Excessive immune activation can affect multiple organs with the most common adverse effects being skin rash, diarrhea, colitis, fatigue, hypothyroidism and anorexia. A restrictive calorie diet, mostly of fat and complex carbohydrates, will mimic fasting and increase resiliency to protect patients from the adverse effects of cancer treatments, by managing the adverse side effects of immune checkpoint inhibitors (ICI) treatments in select cancer patients. The fast mimicking diet (FMD) (Xentigen®) is a calorie restrictive, low-calorie, low-protein, high complex carbohydrate, high-fat diet. The FMD program is a plant-based diet program designed to attain fasting-like effects while providing both macro- and micronutrients to minimize the burden of fasting and adverse effects. The FMD consists of 100% ingredients which are generally regarded as safe (GRAS) and comprises mainly of vegetable-based soups and broths, energy bars, energy drinks, cracker snacks, herbal teas, and supplements. Following a FMD may reduce the adverse effects that some cancer patients experience while following immunotherapy treatments. **Detailed Description:** PRIMARY OBJECTIVES: I. Assess the impact of immunotherapy + FMD/Xentigen® on immune related adverse events rates (irAEs) (including immune-mediated colitis). II. Appraise the impact of immunotherapy + FMD/Xentigen® on the patient's physical function and quality of life. III. Evaluate the impact of immunotherapy + FMD/Xentigen® on surrogate markers of inflammation (i.e., fecal calprotectin) as a predictive marker of immune-mediated colitis. OUTLINE: Patients receive nutrition counseling with a nutritionist over 60 minutes, receive FMD over 4 days for 3 cycles of immunotherapy and educational guidelines for day 5 to transition to a regular diet. Patients undergo blood sample collection throughout the study. Upon completion of study intervention, patients are followed up at 6 months. ### Conditions Module **Conditions:** - Lung Non-Small Cell Carcinoma - Lung Small Cell Carcinoma - Malignant Solid Neoplasm - Melanoma - Renal Cell Carcinoma - Urothelial Carcinoma ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients receive nutrition counseling with a nutritionist over 60 minutes, receive FMD over 4 days for 3 cycles of immunotherapy and educational guidelines for day 5 to transition to a regular diet. Patients undergo blood sample collection throughout the study. **Intervention Names:** - Procedure: Biospecimen Collection - Other: Dietary Intervention - Other: Educational Intervention - Other: Electronic Health Record Review - Other: Interview - Other: Nutritional Assessment - Other: Questionnaire Administration **Label:** Supportive Care (FMD) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Supportive Care (FMD) **Description:** Undergo blood sample collection **Name:** Biospecimen Collection **Other Names:** - Biological Sample Collection - Biospecimen Collected - Specimen Collection **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Supportive Care (FMD) **Description:** Given FMD **Name:** Dietary Intervention **Other Names:** - Dietary Modification - intervention, dietary - Nutrition Intervention - Nutrition Interventions - Nutritional Interventions **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Supportive Care (FMD) **Description:** Receive educational guidelines **Name:** Educational Intervention **Other Names:** - Education for Intervention - Intervention by Education - Intervention through Education - Intervention, Educational **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - Supportive Care (FMD) **Description:** Ancillary studies **Name:** Electronic Health Record Review **Type:** OTHER #### Intervention 5 **Arm Group Labels:** - Supportive Care (FMD) **Description:** Ancillary studies **Name:** Interview **Type:** OTHER #### Intervention 6 **Arm Group Labels:** - Supportive Care (FMD) **Description:** Receive nutrition counseling **Name:** Nutritional Assessment **Other Names:** - Dietary Assessment - dietary counseling - nutritional counseling **Type:** OTHER #### Intervention 7 **Arm Group Labels:** - Supportive Care (FMD) **Description:** Ancillary studies **Name:** Questionnaire Administration **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Symptoms will be measured using a modified version of the Memorial Symptom Assessment Scale. The modified version will contain specific items related to side effects of immune checkpoint inhibitors (ICIs) including twelve GI symptoms, skin changes, and fatigue. The scale includes 24 items for which the participant reports on whether a symptom (e.g., pain, lack of energy, shortness of breath) occurred during the previous week, as well as any distress it may have caused. Questions are answered on a 0-4 or 0-4 scale (e.g., 1=Rarely, 2=Occasionally, 3=Frequently, 4=Almost Constantly). **Measure:** Symptom Measurement **Time Frame:** Up to 6 months **Description:** Will grade the severity of symptoms using the CTCAE v3.0 scale. Will report descriptive analysis of rates and means. Patients will also be asked to report on any incidences of involuntary fasting due to their symptoms. **Measure:** Incidence of adverse events **Time Frame:** Up to 6 months **Description:** Physical function will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function, a 10-item measure of mobility and extremity function that was specifically developed for use in cancer, populations. Items are scored from 1-5 each with higher scores indicating better physical function. **Measure:** Physical function **Time Frame:** Up to 6 months **Description:** Quality of life will be measured using the seven item Functional Assessment of Cancer Therapy (FACT-G), an abbreviated version of the FACT-G. Each item is scored from 0 (not at all) to 4 (very much). Higher overall scores correspond with better quality of life. **Measure:** Quality of life - FACT-G **Time Frame:** Up to 6 months **Description:** Fecal calprotectin will be measured by patients who develop diarrhea or the gastrointestinal side effects. Will be obtained as standard of care to assess for immune mediated colitis if CTCAE v3.0 score is greater than 1. **Measure:** Fecal calprotectin **Time Frame:** At baseline, week 12 and week 24 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥ 18 years * Histological confirmation of melanoma, renal cell carcinoma, urothelial carcinoma, non-small cell lung carcinoma (squamous or adenocarcinoma), and small cell lung carcinoma * Advanced stage disease (stage 3 or 4) appropriate for the following types of immunotherapy: PD-1 antibody (nivolumab, pembrolizumab), PD-L1 antibody (atezolizumab, avelumab, durvalumab), CTLA-4 antibody (ipilimumab) or any combination thereof Exclusion Criteria: * Age \< 18 years * Pregnant women * Nursing mothers * Persons of childbearing potential who are unwilling to employ adequate contraception * Patients will be excluded if diabetic, if they have allergies to any of the components in the FMD, if there is unacceptable deterioration of their nutritional status and cancer progression **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Jacksonville **Contacts:** ***Contact 1:*** - **Email:** mayocliniccancerstudies@mayo.edu - **Name:** Clinical Trials Referral Office - **Phone:** 855-776-0015 - **Role:** CONTACT ***Contact 2:*** - **Name:** Francis A. Farraye, MD, MS - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Mayo Clinic in Florida **State:** Florida **Status:** RECRUITING **Zip:** 32224-9980 #### Overall Officials **Official 1:** **Affiliation:** Mayo Clinic **Name:** Francis A. Farraye, MD, MS **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### See Also Links **Label:** Mayo Clinic Clinical Trials **URL:** https://www.mayo.edu/research/clinical-trials ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000000230 - Term: Adenocarcinoma - ID: D000007680 - Term: Kidney Neoplasms - ID: D000014571 - Term: Urologic Neoplasms - ID: D000014565 - Term: Urogenital 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: D000002283 - Term: Carcinoma, Bronchogenic - ID: D000001984 - Term: Bronchial Neoplasms - ID: D000008175 - Term: Lung Neoplasms - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M5548 - Name: Carcinoma, Renal Cell - Relevance: HIGH - As Found: Renal Cell Carcinoma - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: HIGH - As Found: Lung Non-Small Cell Carcinoma - ID: M28323 - Name: Small Cell Lung Carcinoma - Relevance: HIGH - As Found: Lung Small Cell Carcinoma - ID: M11528 - Name: Melanoma - Relevance: LOW - As Found: Unknown - ID: M5551 - Name: Carcinoma, Transitional Cell - Relevance: LOW - As Found: Unknown - ID: M20433 - Name: Carcinoma, Small Cell - Relevance: HIGH - As Found: Small Cell Carcinoma - ID: M11172 - Name: Lung Neoplasms - 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: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M10703 - Name: Kidney Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17320 - Name: Urologic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M5540 - Name: Carcinoma, Bronchogenic - Relevance: LOW - As Found: Unknown - ID: M5260 - Name: Bronchial Neoplasms - Relevance: LOW - As Found: Unknown - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: T4906 - Name: Renal Cell Carcinoma - Relevance: HIGH - As Found: Renal Cell Carcinoma - ID: T1341 - Name: Clear Cell Renal Cell Carcinoma - Relevance: LOW - As Found: Unknown - ID: T5271 - Name: Small Cell Lung Cancer - Relevance: HIGH - As Found: Lung Small Cell Carcinoma - ID: T5693 - Name: Transitional Cell Carcinoma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000002292 - Term: Carcinoma, Renal Cell - ID: D000002289 - Term: Carcinoma, Non-Small-Cell Lung - ID: D000018288 - Term: Carcinoma, Small Cell - ID: D000055752 - Term: Small Cell Lung Carcinoma ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: LOW - As Found: Unknown - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438575 **Acronym:** PAT **Brief Title:** Point of Care Diagnosis of Vaginal Infections **Official Title:** Point of Care Diagnosis of Vaginal Infections to Ensure Accurate Treatment: (PAT Study) #### Organization Study ID Info **ID:** STUDY24010118 #### Organization **Class:** OTHER **Full Name:** University of Pittsburgh ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-24 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Cepheid #### Lead Sponsor **Class:** OTHER **Name:** Sharon L Hillier #### Responsible Party **Investigator Affiliation:** University of Pittsburgh **Investigator Full Name:** Sharon L Hillier **Investigator Title:** Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Vaginal infections are a common gynecologic issue and may cause significant symptoms and discomfort for individuals. Point of care tests are used to diagnose infections in the office, with an advantage of quick diagnosis and treatment. Examples of point of care tests are urine pregnancy, rapid strep and COVID-19 tests. This study will enroll persons with vaginal complaints and compare diagnosis and treatment based on usual care to diagnosis and treatment using a Food and Drug Administration-approved point of care test for the diagnosis of vaginitis. The study is being done to better understand diagnosis, treatment, and satisfaction using point of care tests compared to usual care. Participants will be randomized to one of two study arms: Arm 1: the healthcare provider will perform their usual evaluation and tests to make the diagnosis and provide treatment, as needed. Arm 2: the provider will be asked to use the results of the point-of-care test being used in the study to make the diagnosis and provide treatment, as needed. Regardless of arm, all diagnoses and treatment will be provided through the healthcare provider. All participants will be contacted 2 weeks later to answer a questionnaire related to diagnosis, treatment, current symptoms, and satisfaction with their visit. Medical records related to vaginal complaints, up to 30 days from enrollment, will be reviewed by the study team to obtain information on symptoms, tests performed, results, and treatments prescribed. **Detailed Description:** The goal of this randomized clinical trial is to evaluate whether same day testing using the Xpert® Xpress MVP test in a patient care setting results in a higher degree of appropriate treatment of vaginitis compared to standard of care for persons having vaginitis symptoms. Approximately 300 individuals who are complaining of vaginitis symptoms and are seeking care at one of the study participating offices within Magee-Womens Hospital will be invited to participate. In this study, the office visit will serve as the enrollment visit. After obtaining informed consent, participants will complete a brief questionnaire and self-collect three vaginal swabs for three tests that are FDA-cleared for vaginitis diagnosis: Xpert® Xpress MVP, BD MAX™ Vaginal Panel, and BD AffirmTM VPIII Microbial Identification Test. Participants will be randomized (1:1) into one of two arms after collecting swabs: Arm 1, vaginitis diagnosis and treatment will be based on usual provider evaluation and treatment during the office visit. The Xpert® Xpress MVP test will be batched with delayed results made available to the provider following the participant's 2-week study follow-up telephone contact . Arm 2, the Xpert® Xpress MVP test will be run in real time as a point of care test at the time of the office visit and the results will be made available to the provider in approximately one hour. Providers will be asked to use the MVP test result for diagnosis and treatment of the participant All participants, regardless of arm, will complete a follow-up telephone contact approximately two weeks after their office visit to assess symptom resolution and satisfaction. Review and collection of electronic medical record information related to the office visit evaluation, testing, diagnosis and treatment will also be included. A Healthcare Provider Sub study will also be performed. The sub study will include a baseline questionnaire completed by clinicians at participating offices and then a follow-up questionnaire administered to clinicians who provided care for at least one study participant. The sub study will help investigators understand how providers feel about point-of-care testing for vaginitis. ### Conditions Module **Conditions:** - Vaginitis - Bacterial Vaginosis - Yeast Vaginitis - Trichomonas Vaginitis **Keywords:** - Point-of-care diagnosis - Vaginitis - Symptomatic ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 350 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Vaginitis diagnosis and treatment will be based on usual provider evaluation and treatment during the office visit **Intervention Names:** - Diagnostic Test: Usual Care **Label:** Usual Care **Type:** OTHER #### Arm Group 2 **Description:** the Xpert® Xpress MVP test will be run in real time as a point of care test at the time of the office visit and the results will be made available to the provider in approximately one hour. Providers will be asked to use the MVP test result for diagnosis and treatment of the participant. **Intervention Names:** - Diagnostic Test: Xpert® Xpress MVP test **Label:** Same Day Results **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Same Day Results **Description:** The Xpert® Xpress MVP is an FDA-cleared point-of-care test for vaginitis diagnosis **Name:** Xpert® Xpress MVP test **Type:** DIAGNOSTIC_TEST #### Intervention 2 **Arm Group Labels:** - Usual Care **Description:** Usual methods used by the healthcare provider for vaginitis diagnosis **Name:** Usual Care **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Other Outcomes **Description:** Number of healthcare providers that respond that they are satisfied or very satisfied with using the Xpert® Xpress MVP to diagnose and treat their patients' vaginitis. Satisfaction is evaluated on a 5-point Likert scale with 1 being very satisfied and 5 being very dissatisfied. **Measure:** Number of healthcare providers that are satisfied with Xpert® Xpress MVP test **Time Frame:** Approximately 14 months #### Primary Outcomes **Description:** Number of participants prescribed appropriate treatment at index visit or within 24 hours of index visit. Appropriate treatment is defined as Centers For Disease Control recommended, or Food and Drug Administration approved treatment based on diagnosis from the self-collected samples. **Measure:** Number of participants prescribed appropriate treatment **Time Frame:** Approximately 24 hours #### Secondary Outcomes **Description:** Number of participants whose vaginitis is correctly diagnosed by their healthcare provider. A positive result from both the Xpert® Xpress MVP and the BD MAX™ Vaginal Panel will be considered the gold standard for diagnosis of vaginitis/vaginosis. **Measure:** Number of participants that receive correct diagnosis of vaginitis **Time Frame:** Approximately 2 weeks **Description:** Number of participants who experience resolution of vaginitis symptoms at the two week follow up contact assessed by participant's self-report. **Measure:** Number of participants who experience resolution of vaginitis symptoms **Time Frame:** Approximately 2 weeks **Description:** Number of participants that respond that they are satisfied or very satisfied with their diagnosis and treatment for vaginitis at the 2-week follow-up visit. Satisfaction is evaluated on a 5-point Likert scale with 1 being very satisfied and 5 being very dissatisfied. **Measure:** Number of participants that are satisfied with their office visit **Time Frame:** Approximately 2 weeks **Description:** Number of participant samples for which the BD AffirmTM VPIII test results agree with the results from the gold standard, defined as a concordant positive or negative result from both the Xpert® Xpress MVP and the BD MAX™ Vaginal Panel. **Measure:** Number of accurate BD AffirmTM VPIII test results **Time Frame:** Approximately 2 weeks ### Eligibility Module **Eligibility Criteria:** Primary study Inclusion Criteria: * Complaining of at least one symptom of vaginitis: vaginal discharge, vaginal odor, vulvar or vaginal itch. Women having vulvar or vaginal discomfort such as irritation, burning, pain of less than 2 months duration are also eligible. Pregnant participants who complain of vaginal discharge will be required to have at least one additional vaginal symptom to be eligible. * Seeking care at one of the participating offices. * Able and willing to provide informed consent. * Willing to undergo all study-related assessments and procedures, including self-collection of vaginal swabs, answering questions/surveys, agreeing to the review and collection of information from their medical record from the office (enrollment/index) visit and up to 4 weeks after the office visit. Exclusion Criteria: * Previous participation in this study. * Any condition, that in the opinion of the investigator, would preclude provision of consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives Healthcare Provider Sub-study Inclusion Criteria: * Able and willing to provide informed consent * Provided clinical care to at least one study participant on the date of their study enrollment * Willing to undergo all study-related assessments including answering questions/surveys **Minimum Age:** 14 Years **Sex:** FEMALE **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** maciis@upmc.edu **Name:** Ingrid Macio, PA-C **Phone:** 4126415455 **Role:** CONTACT **Contact 2:** **Email:** burija@upmc.edu **Name:** Jamie Haggerty **Phone:** 4126415378 **Role:** CONTACT #### Locations **Location 1:** **City:** Pittsburgh **Contacts:** ***Contact 1:*** - **Email:** imacio@mail.magee.edu - **Name:** Ingrid Macio, PA-C - **Phone:** 412-641-5455 - **Role:** CONTACT ***Contact 2:*** - **Email:** jhaggerty@mail.magee.edu - **Name:** Jamie Haggerty - **Phone:** 412-641-5378 - **Role:** CONTACT ***Contact 3:*** - **Name:** Sharon L Hillier, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Magee-Womens Hospital of UPMC **State:** Pennsylvania **Zip:** 15213 #### Overall Officials **Official 1:** **Affiliation:** University of Pittsburgh **Name:** Sharon L Hillier, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Hillier SL, Austin M, Macio I, Meyn LA, Badway D, Beigi R. Diagnosis and Treatment of Vaginal Discharge Syndromes in Community Practice Settings. Clin Infect Dis. 2021 May 4;72(9):1538-1543. doi: 10.1093/cid/ciaa260. **PMID:** 32350529 **Citation:** Schwebke JR, Gaydos CA, Nyirjesy P, Paradis S, Kodsi S, Cooper CK. Diagnostic Performance of a Molecular Test versus Clinician Assessment of Vaginitis. J Clin Microbiol. 2018 May 25;56(6):e00252-18. doi: 10.1128/JCM.00252-18. Print 2018 Jun. **PMID:** 29643195 **Citation:** Wiesenfeld HC, Macio I. The infrequent use of office-based diagnostic tests for vaginitis. Am J Obstet Gynecol. 1999 Jul;181(1):39-41. doi: 10.1016/s0002-9378(99)70433-3. **PMID:** 10411793 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007239 - Term: Infections - ID: D000014623 - Term: Vaginal Diseases - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000091662 - Term: Genital Diseases - ID: D000001424 - Term: Bacterial Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000014245 - Term: Trichomonas Infections - ID: D000011528 - Term: Protozoan Infections - ID: D000010272 - Term: Parasitic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M18971 - Name: Vaginosis, Bacterial - Relevance: HIGH - As Found: Bacterial Vaginosis - ID: M16999 - Name: Trichomonas Vaginitis - Relevance: HIGH - As Found: Trichomonas Vaginitis - ID: M17375 - Name: Vaginitis - Relevance: HIGH - As Found: Vaginitis - ID: M17371 - Name: Vaginal Diseases - Relevance: LOW - As Found: Unknown - ID: M16997 - Name: Trichomonas Infections - Relevance: LOW - As Found: Unknown - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: 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: M14388 - Name: Protozoan Infections - Relevance: LOW - As Found: Unknown - ID: M13185 - Name: Parasitic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016585 - Term: Vaginosis, Bacterial - ID: D000014247 - Term: Trichomonas Vaginitis - ID: D000014627 - Term: Vaginitis ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438562 **Brief Title:** Evaluation of Vitamin A Absorption From Fortified Bouillon **Official Title:** Evaluation of Vitamin A Absorption From Fortified Bouillon Using Post-prandial Retinyl Ester Response in Comparison With an Oil-based Vitamin A Supplement #### Organization Study ID Info **ID:** 2023-0327 #### Organization **Class:** OTHER **Full Name:** University of Wisconsin, Madison #### Secondary ID Infos **Domain:** UW- Madison **ID:** A074600 **Type:** OTHER **Domain:** UW- Madison **ID:** CALS/NUTRITIONAL SCIENCES **Type:** OTHER **Domain:** UW- Madison **ID:** Version 10/19/2023 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Particles for Humanity, PBC **Class:** OTHER_GOV **Name:** Tropical Diseases Research Centre, Zambia #### Lead Sponsor **Class:** OTHER **Name:** University of Wisconsin, Madison #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to measure how well different formulations of vitamin A (VA) are absorbed by the body when they are added to bouillon (broth) as vitamin A palmitate (VAP). Fortifying bouillon cubes with VA is one potential approach to addressing VA deficiency, which is a major public health issue in many low- and lower-income countries. The main question this study aims to answer is to compare the amount of VA that is absorbed by the body from three different VAP formulations that are added to bouillon. Participants will consume different formulations of VA and have multiple blood collections. **Detailed Description:** This study is being conducted to help characterize the absorption of 3 different formulations of VAP (PFH-VAP and BASF-VAP250 vs a positive control) when prepared as broth with an oil dose containing VAP or placebo (referred to as the "study treatments") and consumed by healthy adult women of reproductive age (ages 18 - 49 years). Participants will undergo 3 treatment periods and will be blinded to treatment sequence using a 3-period, 3-treatment crossover design to receive all 3 treatments. All 3 treatment periods will include blood sampling to measure VA levels from pre- through 24 hours post-broth consumption. ### Conditions Module **Conditions:** - Healthy Volunteers - Vitamin A ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** Participants will receive all 3 study treatments over 3 treatment periods. ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** Participants will be randomized and blinded to all treatments and treatment sequence. Care providers and investigators are blinded to experimental treatments and treatment sequence. Outcome assessors are blinded to all treatments and treatment sequence. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Bouillon fortified with vitamin A formulation #1 plus unfortified oil **Intervention Names:** - Dietary Supplement: Bouillon fortified with vitamin A #1 plus unfortified oil **Label:** Vitamin A #1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Bouillon fortified with vitamin A formulation #2 plus unfortified oil **Intervention Names:** - Dietary Supplement: Bouillon fortified with vitamin A #2 plus unfortified oil **Label:** Vitamin A #2 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Unfortified bouillon plus vitamin A fortified oil **Intervention Names:** - Dietary Supplement: Unfortified bouillon plus vitamin A in oil **Label:** Unfortified bouillon positive control **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Unfortified bouillon positive control **Description:** Participants consume unfortified bouillon with vitamin A oil **Name:** Unfortified bouillon plus vitamin A in oil **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Vitamin A #1 **Description:** Participants consume vitamin A #1 fortified bouillon plus unfortified oil **Name:** Bouillon fortified with vitamin A #1 plus unfortified oil **Type:** DIETARY_SUPPLEMENT #### Intervention 3 **Arm Group Labels:** - Vitamin A #2 **Description:** Participants consume vitamin A #2 fortified bouillon plus unfortified oil **Name:** Bouillon fortified with vitamin A #2 plus unfortified oil **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Other Outcomes **Description:** The retinol isotope dilution test provides an estimate of total body stores of vitamin A, (umol) **Measure:** Total body vitamin A using retinol isotope dilution **Time Frame:** Baseline **Description:** The retinol isotope dilution test provides an estimate of liver vitamin A concentrations, (umol/g) **Measure:** Liver vitamin A concentrations using retinol isotope dilution **Time Frame:** Baseline **Description:** To determine inflammation at each treatment visit, (mg/L) **Measure:** C-reactive protein **Time Frame:** Baseline **Description:** Serum carotenoid concentrations will be measured using high-performance liquid chromatography at baseline for each treatment visit, (nmol/L) **Measure:** Serum carotenoids **Time Frame:** Baseline #### Primary Outcomes **Description:** The serum retinyl ester area-under-the-effect-curve (corrected for baseline retinyl ester concentrations) will be calculated for each treatment to determine relative absorption of vitamin A, (nmol/L\*h) **Measure:** Serum retinyl ester area-under-the-effect-curve **Time Frame:** Baseline to 8 hours **Description:** The serum retinyl ester area-under-the-effect-curve (corrected for baseline retinyl ester concentrations) will be calculated for each treatment to determine relative absorption of vitamin A, (nmol/L\*h) **Measure:** Serum retinyl ester area-under-the-effect-curve **Time Frame:** Baseline to 24 hours #### Secondary Outcomes **Description:** Maximum serum retinol concentration observed, (µmol/L) **Measure:** Serum retinol maximum concentration (Cmax) **Time Frame:** Baseline to 24 hours **Description:** Maximum serum retinyl ester concentration observed, (nmol/L) **Measure:** Serum retinyl ester maximum concentration (Cmax) **Time Frame:** Baseline to 24 hours **Description:** Time to maximum serum retinol concentration, (h) **Measure:** Time to maximum serum retinol concentration (Tmax) **Time Frame:** Baseline to 24 hours **Description:** Time to maximum serum retinyl ester concentration, (h) **Measure:** Time to serum retinyl ester maximum concentration (Tmax) **Time Frame:** Baseline to 24 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy, nonpregnant women * ≥18 and \<49 years of age * Able and willing to provide informed consent * Body mass index (BMI) between 20 to 30 kg/m2 * Willing and able to undergo study procedures, including: repeated blood sampling, a baseline hemoglobin and pregnancy test, adherence to a low-vitamin A diet at specified times throughout the study, consumption of provided meals (specifically, a breakfast of bouillon, peanut butter, and a bagel or bread), and, except for the Screening visit, foregoing alcohol for at least 2 days before each visit and fasting for ≥8 hours before each visit Exclusion Criteria: * Currently pregnant * Breastfeeding a child under 1 year of age * Allergic to soy or peanut butter * Current use of smoking tobacco products or any other form of nicotine * Active eating disorder diagnosis * Current diagnosis of acute or chronic illness, including hepatitis, Celiac's disease, Crohn's disease, and cystic fibrosis * Moderate or severe anemia according to World Health Organization guidelines (i.e., hemoglobin ≤10.9 g/dL) * Unable or unwilling to refrain from consuming alcohol when required * Unable or unwilling to discontinue consumption of foods that are high in vitamin A and of vitamin A supplements when required during the study * Taking prescription oral medication that includes a retinoid, e.g., isotretinoin/ Accutane * Taking proton pump inhibitors. * Unable/unwilling to avoid taking antacids during the fasting period prior to sample collection * Unable/unwilling to fast for periods of at least 10 hours at a time * Status relationship with a member of the study team. * Unable to fulfill study requirements per the judgment of the investigator **Healthy Volunteers:** True **Maximum Age:** 49 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** bgannon@wisc.edu **Name:** Bryan Gannon, PhD **Phone:** 608-265-2026 **Role:** CONTACT #### Locations **Location 1:** **City:** Madison **Contacts:** ***Contact 1:*** - **Email:** bgannon@wisc.edu - **Name:** Bryan Gannon, PhD - **Phone:** 608-265-2026 - **Role:** CONTACT ***Contact 2:*** - **Name:** Sherry A Tanumihardjo, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Bryan M Gannon, PhD - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Luke M Funk, MD, MPH - **Role:** SUB_INVESTIGATOR **Country:** United States **Facility:** University of Wisconsin-Madison **State:** Wisconsin **Zip:** 53706 **Location 2:** **City:** Ndola **Contacts:** ***Contact 1:*** - **Email:** jbchile@yahoo.com - **Name:** Justin Chileshe, PhD - **Role:** CONTACT ***Contact 2:*** - **Name:** Justin Chileshe, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Zambia **Facility:** Tropical Diseases Research Centre **Location 3:** **City:** Rufunsa **Contacts:** ***Contact 1:*** - **Email:** jbchile@yahoo.com - **Name:** Justin Chileshe, PhD - **Role:** CONTACT ***Contact 2:*** - **Name:** Justin Chileshe, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Zambia **Facility:** Tropical Diseases Research Centre - Field Office #### Overall Officials **Official 1:** **Affiliation:** University of Wisconsin, Madison **Name:** Sherry Tanumihardjo, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** University of Wisconsin, Madison **Name:** Bryan M Gannon, PhD **Role:** STUDY_DIRECTOR **Official 3:** **Affiliation:** University of Wisconsin, Madison **Name:** Luke M Funk, MD, MPH **Role:** STUDY_DIRECTOR **Official 4:** **Affiliation:** Tropical Diseases Research Centre, Zambia **Name:** Justin Chileshe, PhD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000018977 - Term: Micronutrients - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000975 - Term: Antioxidants - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000020011 - Term: Protective Agents - ID: D000016588 - Term: Anticarcinogenic Agents - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M17558 - Name: Vitamins - Relevance: HIGH - As Found: Period - ID: M17544 - Name: Vitamin A - Relevance: HIGH - As Found: Good - ID: M302395 - Name: Retinol palmitate - Relevance: HIGH - As Found: Good - ID: M21319 - Name: Acetic Acid - Relevance: LOW - As Found: Unknown - ID: M303111 - Name: Retinol acetate - 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: M4292 - Name: Antioxidants - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown - ID: T468 - Name: Vitamin A - Relevance: HIGH - As Found: Good - ID: T462 - Name: Retinol - Relevance: HIGH - As Found: Good - ID: T436 - Name: Acetic Acid - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000014815 - Term: Vitamins - ID: D000014801 - Term: Vitamin A - ID: C000014794 - Term: Retinol palmitate ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438549 **Acronym:** SFHOPE **Brief Title:** Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation **Official Title:** Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation: A Pilot Feasibility Study #### Organization Study ID Info **ID:** 5220112 #### Organization **Class:** OTHER **Full Name:** Loma Linda University #### Secondary ID Infos **Domain:** Tobacco-related Disease Research Program (TRDRP) **ID:** T32KT4784 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2025-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-02 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-24 **Type:** ACTUAL **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-04-18 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of California, San Francisco **Class:** OTHER **Name:** Riverside University Health System Medical Center #### Lead Sponsor **Class:** OTHER **Name:** Loma Linda University #### Responsible Party **Investigator Affiliation:** Loma Linda University **Investigator Full Name:** Anne Berit Petersen **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This develops a novel behavioral tobacco cessation program for pregnant smokers in San Bernardino County. **Detailed Description:** This study seeks to address the disparities in the maternal smoking cessation outcomes of previous research by developing an innovative maternal tobacco cessation program that expands the outreach by integrating home visits by community health workers (CHW) into the prenatal healthcare model. The overall aim is to conduct a pilot randomized control trial to test the feasibility, acceptability, and efficacy of a Healthcare Provider-Community Health Worker (HCP-CHW) intervention model that expands outreach by adding eight home visits by CHWs to provide tobacco cessation support services before and after the quit date. ### Conditions Module **Conditions:** - Tobacco Use - Tobacco Use Cessation - Tobacco Use in Childbirth **Keywords:** - prevention - treatment - disparities and social inequality - tobacco use cessation - community health worker - pregnant smokers ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The model compares the integration of CHW Home visits into healthcare provider-directed clinical care and a schedule of CHW home visits to provide behavioral smoking cessation for pregnant people and adult household members before, during, and after a quit date vs Standard of Care. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 105 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** CHW visit with brief tobacco cessation intervention. **Intervention Names:** - Behavioral: HCP-CHW Integration into Prenatal Care for Smoking Cessation **Label:** Integrated HCP-CHW Intervention Arm **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Standard of Care **Intervention Names:** - Other: Control Arm **Label:** Control arm **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Integrated HCP-CHW Intervention Arm **Description:** CHWs will be integrated into primary care, and subjects will receive CHW home visits (up to 8) that will provide brief behavioral smoking cessation interventions before, during, and after a quit date. This brief behavioral intervention will include watching a video and reviewing self-help materials. **Name:** HCP-CHW Integration into Prenatal Care for Smoking Cessation **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Control arm **Description:** Standard of Care which provides referrals to community-based smoking cessation resources. **Name:** Control Arm **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The 7 Day Point Prevalence Abstinence (PPA) questionnaire will be administered to subjects to assess the following: Tobacco use within past seven days **Measure:** Self-Report Tobacco Abstinence **Time Frame:** Change between baseline enrollment and 1 month postpartum visit, typically ten months #### Secondary Outcomes **Description:** Breathalyzer test will be administered to subjects to determine CO level. Subjects will then be classified per CO level as: Nonsmoker = 0 to 3 Borderline = 4 to 6 Smoker = 7 and above Smoker Low Addiction = 7 to 10 Smoker Moderate Addiction = 11 to 15 Smoker Heavily Addicted = 16 to 25 Smoker Very heavily Addicted = 26+ **Measure:** Carbon Monoxide Level **Time Frame:** Change between baseline and 1 month postpartum visit, typically ten months **Description:** The acceptability of the intervention will be assessed using composite Likert scale measures of process outcomes such as 1) overall patient satisfaction, 2) increasing patient motivation and confidence, and 3) willingness to recommend the program to others. Likert scale interpretations for overall satisfaction: 1=Very Dissatisfied; 2=Dissatisfied; 3=Neutral; 4=Satisfied; 5=Very Satisfied. Likert scale interpretation for patient motivation and confidence: 1=Strongly Disagree (The intervention did not increase motivation/confidence at all); 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree (The intervention significantly increased motivation/confidence). Likert scale interpretation for Willingness to Recommend the Program to Others: 1=Not at all likely; 2=Unlikely; 3=Neutral; 4=Likely; 5=Very Likely. **Measure:** Arm 1 Satisfaction with CHW visit **Time Frame:** Baseline; during the intervention; through study completion, an average of 10 months. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * \< 24 weeks pregnant * age \> 18 years, * current smokers (100 cigarettes in their lifetime and \>3 cigarettes per day in the last 7 days; including poly-tobacco use, combining cigarettes with non-combustible products) confirmed by expired carbon monoxide (CO) * willing to quit smoking and set a quit date in the next 2 weeks upon enrolling * enrolled in prenatal care at Loma Linda University Health (LLUH) or Riverside University Health System (RUHS) Exclusion Criteria: * severe mental health problems that prevent informed consent and/or CHW intervention * women who were on Nicotine Replacement Therapy (NRT) or enrolled in a cessation program within 30 days * unwillingness to participate in audio-recorded key informant interviews or focus groups **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** abpetersen@llu.edu **Name:** Anne Berit Petersen **Phone:** 909 558 1000 **Phone Ext:** 42846 **Role:** CONTACT **Contact 2:** **Email:** psingh@llu.edu **Name:** Pramil Singh **Role:** CONTACT #### Locations **Location 1:** **City:** Loma Linda **Contacts:** ***Contact 1:*** - **Email:** COUMartin@llu.edu - **Name:** Courtney Martin, DO - **Phone:** 909-558-1000 - **Phone Ext:** 15504 - **Role:** CONTACT **Country:** United States **Facility:** Loma Linda University Medical Center **State:** California **Status:** RECRUITING **Zip:** 92350 **Location 2:** **City:** Moreno Valley **Contacts:** ***Contact 1:*** - **Email:** B.Oshiro@ruhealth.org - **Name:** Bryan Oshiro, MD - **Role:** CONTACT **Country:** United States **Facility:** Riverside University Health Systems **State:** California **Status:** NOT_YET_RECRUITING **Zip:** 92555 #### Overall Officials **Official 1:** **Affiliation:** Loma Linda University **Name:** Anne Berit Petersen, PhD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### See Also Links **Label:** Study website **URL:** https://smokefreehope.org/ ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438536 **Acronym:** STEPS **Brief Title:** STEPS: A Virtual Reality-based Intervention for Adults With Autism. **Official Title:** STEPS (Social Cognitive Training Enhancing Pro-functional Skills): A Clinical Randomized Trial Evaluating the Effect of a Virtual Reality-based Intervention for Adults With Autism. #### Organization Study ID Info **ID:** H-23055504 #### Organization **Class:** OTHER **Full Name:** Mental Health Services in the Capital Region, Denmark ### Status Module #### Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-30 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-02 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mental Health Services in the Capital Region, Denmark #### Responsible Party **Investigator Affiliation:** Mental Health Services in the Capital Region, Denmark **Investigator Full Name:** Louise Birkedal Glenthoej **Investigator Title:** DMSc, PhD, psychologist with specialization in psychiatry and specialist in psychotherapy **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 clinical trial is to learn if a new Virtual Reality-based intervention will be effective in treating social cognitive challenges in adults with autism. The main questions it aims to answer are: 1. Is Virtual Reality-based social cognitive training effective in reducing social cognitive deficits and improving psychosocial functioning, quality of life, and clinical symptoms in adults with ASD? 2. Is Virtual Reality-based social cognitive training cost-effective? Researchers will compare Virtual Reality-based pro-functional, Social Cognitive Training (VRSCT) to treatment as usual (TAU) to evaluate effectiveness. Participants will be allocated to receive either VRSCT once a week in addition to treatment as usual (TAU) or TAU alone for 3 months. All participants will undergo a thorough assessment at baseline, and at 3 and 6 months post-baseline. **Detailed Description:** Adults with autism spectrum disorders (ASD) constitute an increasingly recognized population with largely unaddressed public health needs. Research on effective interventions for adults with ASD lags far behind that dedicated to children with ASD, as well as other psychiatric disorders. Adults with ASD show prominent social cognitive deficits that impede their daily functioning such as being able to interact socially, to achieve adequate vocational functioning (i.e. job/educational achievements) as well as inflicting immensely on their quality of life. At current, no robust and replicated evidence exists on a pro-functional treatment targeting social cognitive deficits in adults with ASD. Virtual reality-based treatment offers the possibility of creating artificial experiences in real time, that make the user feel immersed and able to interact as if it was the real world. Additionally, virtual reality therapy allows for personalization of the therapy to match the specific social challenges of each patient. Preliminary findings suggest virtual reality exposure to lead to faster symptom reduction than traditional therapy and may therefore be cost-effective. While the potential beneficial effects of virtual reality exposure to challenging social situations, that taps social cognitive functions, are evident and virtual reality therapies are promising in general, the research field is in urgent need of evidence on the effectiveness of virtual reality therapy in adults with ASD. The STEPS trial evaluates the effect of a Virtual Reality-based pro-functional, Social Cognitive Training (VRSCT) versus treatment as usual. We expect to find VRSCT to be more beneficial in improving social cognitive deficits, daily life functioning, and quality of life in adults with ASD. If the results of the current trial are positive, this short-term, manualised treatment using well-tested VR-software, can easily be implemented in clinical practice, that is in the psychiatric out-patient facilities or in community-based facilities where it can benefit a large group of suffering ASD patients. Additionally, it can be adapted for use in related clinical target groups such as adolescents with ASD or patients with psychosis experiencing social cognitive and functional deficits. ### Conditions Module **Conditions:** - Autism Spectrum Disorder **Keywords:** - Randomized clinical trial (RCT) - Virtual Reality (VR) - Social cognitive training - Cognitive remediation - Digital intervention ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The study is a high-quality randomized, assessor-blinded parallel-groups superiority clinical trial fulfilling the CONSORT criteria for non-pharmacological treatment. A total of 140 adults with ASD will be allocated to receive either 12 weeks of Virtual Reality-based Social Cognitive Training (VRSCT) + treatment as usual (TAU) or TAU. All participants will be assessed at baseline and at 3- and 6-months post-baseline. ##### Masking Info **Masking:** DOUBLE **Masking Description:** Stratified block randomization with concealed randomization sequences will be conducted after baseline assessment. Independent assessors blinded to the treatment will evaluate outcomes. Analysis of outcomes will be carried out following the intention-to-treat principles. **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 140 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients in the experimental group will be offered 10 individual sessions of targeted, virtual reality assisted psychotherapy embedded in cognitive behavioral therapy (CBT), that aims at enhancing social cognition and daily life functioning. If the patient consents, two additional sessions will be offered in which the patient's relatives are invited to participate (one in the beginning of treatment and one at the end of treatment). The aim of the relative involvement is to enhance transfer from the therapy to the patients daily life. The treatment will be conducted by psychologists with an extensive knowledge in providing virtual reality assisted therapy. The treatment is manualized, and the therapists will receive ongoing supervision by a senior clinician having ≥ 25 years of experience in conducting assessment, treatment, and research with the autism spectrum population. **Intervention Names:** - Behavioral: Virtual Reality-based Social Cognitive Training **Label:** Virtual Reality-based Social Cognitive Training (VRSCT) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The treatment-as-usual (TAU) group will receive the standard treatment offered to adults diagnosed with ASD in Denmark. This commonly consists of four psychoeducational sessions as well as limited supportive counseling. Some adults with ASD also receive practical help in daily life situations in community settings. The TAU will be mapped upon trial completion. **Label:** Treatment as Usual (TAU) **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Virtual Reality-based Social Cognitive Training (VRSCT) **Description:** Virtual reality assisted social cognitive training embedded in cognitive behavioral therapy, that aims at enhancing social cognition and daily life functioning. **Name:** Virtual Reality-based Social Cognitive Training **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** The Camouflaging Autistic Traits Questionnaire (CAT-Q) is a 25-item self-report measure of social camouflaging behaviours for individuals of age 16 and above. Each item is rated on a likert scale from 1 (Strongly Disagree) to 7 (Strongly Agree). The total score ranges from 25-175 with higher scores reflecting greater degree of camouflaging. **Measure:** CAT-Q (Camouflaging Autistic Traits Questionnaire) **Time Frame:** Baseline, 3 month follow-up and 6 month follow-up **Description:** The SR-AS is a self-report instrument for sensory reactivity. It can be used for evaluation of sensory symptoms as described in DSM-5 for autism spectrum conditions. The instrument comprises statements about reactions to sensory input. The task is to self-rate the statements rated on a likert scale from 0 (Totally Disagree) to 3 (Totally Agree). Total scores ranges from 0 - 96. **Measure:** SR-AS (Questionnaire on sensory reactions) **Time Frame:** Baseline, 3 month follow-up and 6 month follow-up **Description:** The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Each item is rated on a 4-point scale from 0 (symptom absent) to 3 (severe symptoms). The total score ranges from 0 to 63, with higher scores reflecting greater degree of depressive symptoms. **Measure:** Beck Depression Inventory (BDI) **Time Frame:** Baseline, 3 month follow-up and 6 month follow-up **Description:** The Intolerance of Uncertainty Scale (IUS-12) is a 12-item, self-report questionnaire measuring the tendency to think or react negatively toward uncertain events. IUS-12 consists of 12 items (e.g., "It frustrates me not having all the information I need") and is scored on a 5-point Likert scale from 1 ("Not at all characteristic of me") to 5 ("Very Characteristic of me"). The total score ranges from 12 to 60. A greater score indicates a greater level of negative reactions towards uncertainty. **Measure:** Intolerance of Uncertainty Scale (IUS-12) **Time Frame:** Baseline, 3 month follow-up and 6 month follow-up **Description:** The General Alexithymia Factor Score (GAFS-8) is a 8-item, self-administered questionnaire that measures alexithymia. Each item is scored on a 5-point Likert-type scale 1 (strongly disagree) to 5 (strongly agree). Total score is ranging from 8 to 4, with higher scores indicating greater impairment/challenges. **Measure:** General Alexithymia Factor Score (GAFS-8) **Time Frame:** Baseline, 3 month follow-up and 6 month follow-up **Description:** RBQ-3 is a 20-item self-report questionnaire that measures of restricted and repetitive behaviours and interests (RRBIs). All items are scored on a 4-point Likert-type scale ranging from 1 (Never or rarely) to 5 (30 or more times daily/Serious or extreme/Serious or severe). RBQ-3 Mean Total Score is obtained adding each individual's score of 1, 2, 3 or 4 across every item in the questionnaire. This total is then divided by the number of items completed for each individual. A score of between1-4 is generated. A higher mean score reflects higher level of RRBIS. **Measure:** The Repetitive Behaviour Questionnaire-3 (RBQ-3) **Time Frame:** Baseline, 3 month follow-up and 6 month follow-up **Description:** Inventory of Psychotic-Like Anomalous Self-Experiences (IPASE) is a self-report measure of minimal self-disturbance. IPASE consists of 57-item self-report scale in which participants indicate how much they agree with statements on a scale ranging from 1 (strongly disagree) to 5 (strongly agree). Total score ranges from 57 to 285. Higher scores reflects more psychotic-like anomalous self-experiences. **Measure:** Inventory of Psychotic-Like Anomalous Self-Experiences (IPASE) **Time Frame:** Baseline, 3 month follow-up and 6 month follow-up **Description:** The Green Paranoid Thought Scale consists of a 32 item self-report measure of paranoia designed for both clinical and non-clinical populations. Part A assesses ideas of reference (e.g. 'It was hard to stop thinking about people talking about me behind my back') and Part B assesses ideas of persecution (e.g. 'I was convinced there was a conspiracy against me'). Each item is rated on a five-point scale (1-5). Scores on each scale can range from 16 to 80. Higher scores indicate greater levels of paranoid thinking. **Measure:** Green Paranoid Thought Scale (GPTS) **Time Frame:** Baseline, 3 month follow-up and 6 month follow-up **Description:** The Adult ADHD Self-Report Scale (ASRS) is an 18-item self-report questionnaire designed to assess Attention Deficit Hyperactivity Disorder (ADHD) symptoms in adults. The ASRS consists of an 18-item scale evaluating the dimensions of inattention and hyperactivity-impulsiveness subtypes of ADHD in adults. The ASRS full edition consists of nine items that represent symptoms related to inattention (items 1-4 and 7-11), and nine items assessing symptoms of hyperactivity-impulsiveness (items 5-6 and 12-18). Each of the items is scored on a five-point Likert rating scale with 0="never", 1="rarely", 2="sometimes", 3="often", and 4="very often" based on the participant's experiences over the last 6 months. A high score indicates a greater severity of self-reported ADHD symptoms. Assessments will comprise ratings of the previous 1-month period. **Measure:** Adult ADHD Self-Report Scale (ASRS) **Time Frame:** Baseline, 3 month follow-up and 6 month follow-up **Description:** The SSPA is a performance-based test, that measure social behaviour. SSPA consists of two communication scenarios: One that involves the participants introducing themselves to a new neighbour and one that involves the participants requesting their landlord to fix a leak after the landlord had previously agreed to fix the leak but had never completed the task. The test is measuring both social competence and appropriateness and is scored on 17 items in total. All items are rated on a five-point (1-5) scale, with 1 as the lowest and 5 as the highest score. In scenario one the minimum score is 1\*8=8. The maximum score: 5\*8=40. In scenario two, the minimum score: 1\*9=9. Maximum score: 5\*9=45. The SSPA Total score ranges from 17 to 85. Higher scores reflect higher social competence and appropriateness. **Measure:** Social Skills Performance Assessment (SSPA) **Time Frame:** Baseline, 3 month follow-up and 6 month follow-up **Description:** WHO-5 is a self-report questionnaire assessing subjective psychological well-being. The questionnaire consists of 5 items and is scored from 0 (At no time) to 5 (all of the time). The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being. **Measure:** WHO-5 Well-Being Index (WHO-5) **Time Frame:** Baseline, 3 month follow-up and 6 month follow-up **Description:** GSE is a self-report questionnaire assessing perceived self-efficacy. GSE consists of 10 items rated on a Likert scale ranging from 1 (not at all true) to 4 (exactly true). Higher scores indicate greater self-efficacy. Total score ranges from 10 to 40. **Measure:** General Self Efficacy Scale (GSE) **Time Frame:** Baseline, 3 month follow-up and 6 month follow-up **Description:** EQ-5D is a self-report questionnaire measuring health-related quality of life. The questionnaire is a description of the subject's current health in 5 dimensions i.e., mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The subject is asked to grade their own current level of function in each dimension into one of three degrees of disability (severe, moderate or none). The combination of these with the conditions "death" and "unconscious" enables description of 245 different health states. The EQ-5D will be used for health outcomes studies and economic analyses **Measure:** EuroQOL five dimensions questionnaire (EQ-5D) **Time Frame:** Baseline, 3 month follow-up and 6 month follow-up **Description:** DPAS contains 15 items assessing an individual's tendency to overgeneralize from past failures to expected future failures (e.g. "If I fail partly, it is as bad as being a complete failure", "People will probably think less of me if I make a mistake", "If I ask a question, it makes me look inferior"). Scoring for these items is on a 7 point scale (1-7) with higher scores indicating greater severity of defeatist attitudes (range for DPAS total = 15-105). **Measure:** Defeatist Performance Attitude Scale (DPAS) **Time Frame:** Baseline, 3 month follow-up and 6 month follow-up **Description:** TUCP is a self-report questionnaire measuring participation in community activities during the last 30 days. TUCP assess 26 areas of life, such as working for pay, going to a movie and going to a library with 26 items. **Measure:** Temple University Community Participation Measure (TUCP) **Time Frame:** Baseline, 3 month follow-up and 6 month follow-up **Description:** PSP is a a semi-structured interview assessing daily life social functioning in the domains social relations, job/education, personal hygiene, aggressive behaviour. Scores ranging from 1-100, with a score of 100 reflecting the best personal and social functioning **Measure:** Personal and Social Performance Scale (PSP) **Time Frame:** Baseline, 3 month follow-up and 6 month follow-up **Description:** DACOBS is a self-report questionnaire measuring cognitive biases. 42 Items are rated on a 7-point Likert scale, ranging from 1 (Strongly disagree) to 7 (Strongly agree) with higher scores indicating more strongly held cognitive biases. Total scores ranging from 42-294. **Measure:** Davos Assessment of the Cognitive Biases Scale (DACOBS) **Time Frame:** Baseline, 3 month follow-up and 6 month follow-up **Description:** The TASIT-S is a measure of emotion perception and Theory of Mind. The TASIT-S part 2 Social Inference - Minimal is a Theory of Mind task, that is comprised of 9 video clips depicting sincere (4 items) and sarcastic interactions (5items) between two actors. For each video 4-items is scored. Total scores ranging from 4\*0 = 0 to 4\*9=36. **Measure:** The Awareness of Social Inference Test - Short Form, part 2 Social Inference, Minimal (TASIT-S) **Time Frame:** Baseline, 3 month follow-up and 6 month follow-up **Description:** The Hinting task measures ability to infer others' true intentions from indirect speech. Participants read 10 vignettes of two characters interacting, ending with one character hinting at his or her true thoughts, feelings, or intentions. Participants give open-ended responses of what the character truly meant, and if their answer is wrong, the experimenter reads a second hint. Answering correctly on the first hint yields two points, while the second hint yields one. The hinting task is scored for total correct out of 20. Minimum score is 0 and maximum score is 20. **Measure:** The Hinting Task **Time Frame:** Baseline, 3 month follow-up and 6 month follow-up **Description:** BRIEF-A is a self-report questionnaire, that includes 75 items assessing executive function. Participants rate whether a specific behavior is a problem on a 3-point Likert scale (0 = Never, 1 = Sometimes, 2 = Often). The global score (General Executive Function) ranges from 0-225. Higher scores indicate more problems with executive functioning. **Measure:** Behavior Rating Inventory of Executive Function - Adult Version, Self-Report (BRIEF-A, Self-Report) **Time Frame:** Baseline, 3 month follow-up and 6 month follow-up **Description:** CSQ is an 8 item self-report measuring client satisfaction with the intervention. All items are scored on a 4-point Likert scale ranging from bad (1) to excellent (4). Higher scores indicate higher satisfaction. **Measure:** Client Satisfaction Questionnaire (CSQ) **Time Frame:** 3 month follow-up **Description:** NEQ is a 32-item self-report questionnaire measuring negative events and outcomes in the participants life during the intervention period. All items are rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Higher score reflects higher rate of negative events. **Measure:** Negative Effects Questionnaire (NEQ) **Time Frame:** 3 month follow-up **Description:** MPS-MSDV is a self-report questionnaire measuring presence in virtual reality. The modified, shortened Danish Version consist of 10 selected items scored on a 5-point Likert Scale ranging from 1 (Strongly disagree) to 5 (Strongly agree). Higher scores reflect higher degree of presence in Virtual Reality. The MPS-MSDV will be administered only to participants in the experimental group. **Measure:** Multimodal Presence Scale, Modified Shortened Danish Version (MPS-MSDV) **Time Frame:** 3 and 10 weeks post baseline **Description:** VRSSQ-MDV is a is a self-report questionnaire measuring virtual reality simulation sickness. The Modified Danish Version consist of 9 items rated on a 4-point Likert Scale ranging from 0 (not at all) to 3 (a lot). Higher scores reflect higher degree of virtual reality simulation sickness. The VRSSQ-MDV will be administered only to participants in the experimental group. **Measure:** Virtual Reality Simulation Sickness Questionnaire, Modified Danish Version (VRSSQ-MDV) **Time Frame:** 3 and 10 weeks post baseline **Description:** RTQ is a 6-item self-report questionnaire measuring the participants positive attitude and preparedness to enter therapy for the purpose of resolving problems. Each item is scored on a 5-point Likert scale ranging from strongly disagree (0) to strongly agree (4). Item 2, 3 and 6 are reversed scored. A higher score indicated greater readiness for therapy. The RTQ will be administered only to participants in the experimental group. **Measure:** Readiness for Therapy Questionnaire (RTQ) **Time Frame:** 1 week post baseline #### Primary Outcomes **Description:** The primary outcome is level of social impairment is measured by the Social Responsiveness Scale, Second Edition, Adult version, Self-report (SRS-2A) at cessation of treatment at 3-months. SRS-2A measures the presence and severity of social impairment in everyday life. The SRS-2A is a commonly used measure in autism spectrum research and has demonstrated good reliability and validity. SRS-2A is a 65-item rating scale, scored on on a 4-point Likert Scale (0-3). Each item is scaled from 0 (never true) to 3 (almost always true), generating a total score ranging from 0 to 195. The SRS-2A is provides a continuous measure of social impairment, where a higher score reflects a greater degree of difficulties with social interactions in everyday life. Follow-up assessments will comprise ratings of the previous two-week period. **Measure:** Social Responsiveness Scale, Adult Version, Self-report **Time Frame:** Baseline, 3 month follow-up and 6 month follow-up #### Secondary Outcomes **Description:** Social Responsiveness Scale, Adult Version, Informant Report is a 65-item rating scale, scored on on a 4-point Likert Scale (0-3). Each item is scaled from 0 (never true) to 3 (almost always true), generating a total score ranging from 0 to 195. The SRS-2A is provides a continuous measure of social impairment, where a higher score reflects a greater degree of difficulties with social interactions in everyday life. Follow-up assessments will comprise ratings of the previous two-week period. **Measure:** Social Responsiveness Scale, Adult Version, Informant Report **Time Frame:** Baseline, 3 month follow-up and 6 month follow-up **Description:** SIAS is a self-report questionnaire measuring social anxiety in social interaction. SIAS consists of 20 items that are rated on a 5-point Likert scale ranging from 0 (not at all characteristic of me) to 4 (extremely characteristic of me). Item 5, 9 and 11 are positively worded items and have reverse scoring. A total SIAS score is generated by summing the ratings ranging from 0 to 80. Higher scores reflects a higher degree of social anxiety in social interaction. **Measure:** Social Interaction Anxiety Scale (SIAS) **Time Frame:** Baseline, 3 month follow-up and 6 month follow-up **Description:** The Empathy Quotient (EQ) is a 60-item questionnaire designed to measure empathy in adults. Each item is scored on a 4-point scale (strongly agree, slightly agree, slightly disagree, strongly disagree). Items 1, 6, 19, 22, 25, 26, 35, 36, 37, 38, 41, 42, 43, 44, 52, 54, 55, 57, 58, 59, and 60 are assigned two points if rated as 'strongly agree' and one point if rated 'slightly agree.' Items 4, 8, 10, 11, 12, 14, 15, 18, 21, 27, 28, 29, 32, 34, 39, 46, 48, 49, and 50 are assigned two points if rated as 'strongly disagree' and one point if rated 'slightly disagree.' The minimum score achievable is 0, and the maximum score is 80. A higher score indicates higher levels of empathy in adults. **Measure:** The Empathy Quotient **Time Frame:** Baseline, 3 month follow-up and 6 month follow-up **Description:** The High Risk Social Challenge task (HiSoC) is a standardized, performance-based task assessing social skills in terms of affect, odd behaviour and language and social-interpersonal skills. Following a short verbal instruction, the participants are being video-taped for 45 seconds while performing a task. HiSoC consists of 16 items that are rated on a 5-point Likert scale from 1 to 5. Smaller ratings reflect low levels of appropriate, effective social behavior. Larger ratings reflect high levels of appropriate, effective social behavior. A total HiSoC score is generated by summing the rating ranging from 16 to 80. Higher scores reflects a higher degree of social skills. **Measure:** The High Risk Social Challenge Task (HiSoC) **Time Frame:** Baseline, 3 month follow-up and 6 month follow-up **Description:** Computer-morphed images derived from the facial features of real individuals, each showing a specific emotion, are displayed on the screen, one at a time. Each face is displayed for 200ms and then immediately covered up to prevent residual processing of the image. The participant must select which emotion the face displayed from 6 options (sadness, happiness, fear, anger, disgust or surprise).The outcome measures for ERT cover percentage and number correct or incorrect and overall response latencies, which can be looked at either across individual emotions or across all emotions at once. **Measure:** Emotion Recognition Task (CANTAB ERT) **Time Frame:** Baseline, 3 month follow-up and 6 month follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age of 18 years or older 2. Ability to give informed consent 3. Diagnosis of an autism spectrum disorder (ICD-10 code F84.0; F84.1; F84.5; F84.8) 4. T-score on SRS-A self-report ≥ 60 Exclusion Criteria: 1. Rejecting informed consent 2. A diagnosis of organic brain disease 3. Intellectual disability (IQ ˂ 70) 4. A command of spoken Danish or English inadequate for engaging in therapy 5. ADHD-diagnosis with untreated symptoms 6. Displaying an imminent homicidal or suicidal risk **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** johannes.andresen@regionh.dk **Name:** Johannes Andresen, MSc Psych **Phone:** 20360116 **Phone Ext:** +45 **Role:** CONTACT **Contact 2:** **Email:** alberte.cathrine.ehrhardt.jeppesen@regionh.dk **Name:** Alberte Cathrine E. Jeppesen, MSc Psych **Phone:** 20311064 **Phone Ext:** +45 **Role:** CONTACT #### Locations **Location 1:** **City:** Copenhagen **Country:** Denmark **Facility:** Copenhagen Research Centre for Mental Health (CORE), Mental Health Centre Copenhagen, Mental Health Services in the Capital Region, Denmark **State:** Hellerup **Status:** RECRUITING **Zip:** 2900 #### Overall Officials **Official 1:** **Affiliation:** Copenhagen Research Centre for Mental Health (CORE), Mental Health Centre Copenhagen **Name:** Louise B. Glenthøj, DrMSc **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002659 - Term: Child Development Disorders, Pervasive - ID: D000065886 - Term: Neurodevelopmental Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4623 - Name: Autistic Disorder - Relevance: HIGH - As Found: Autism - ID: M206 - Name: Autism Spectrum Disorder - Relevance: HIGH - As Found: Autism Spectrum Disorder - ID: M5903 - Name: Child Development Disorders, Pervasive - Relevance: LOW - As Found: Unknown - ID: M5902 - Name: Developmental Disabilities - Relevance: LOW - As Found: Unknown - ID: M30644 - Name: Neurodevelopmental Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001321 - Term: Autistic Disorder - ID: D000067877 - Term: Autism Spectrum Disorder ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438523 **Brief Title:** A-prf,Nanochitosan Combined With A-prf Compared to Chitosan for Symptomatic Irreversible Pulpitis of Mature Teeth **Official Title:** A-prf,Nanochitosan Combined With A-prf Scaffold Compared to Chitosan in Vital Pulp Therapy for Symptomatic Irreversible Pulpitis of Mature Permanent Mandibular First Molar Teeth .Randomized Controlled Trials #### Organization Study ID Info **ID:** 29 #### Organization **Class:** OTHER **Full Name:** Future University in Egypt ### Status Module #### Completion Date **Date:** 2025-09-02 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-30 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05-02 **Type:** ESTIMATED #### Start Date **Date:** 2023-09-02 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Future University in Egypt #### Responsible Party **Investigator Affiliation:** Future University in Egypt **Investigator Full Name:** Mai Sherif **Investigator Title:** Researcher **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:** Clinical and radiographic assessment of A-prf,A-prf combined with nanochitosan compared to chitosan for symptomatic irreversible pulpits in lower permanent first molar **Detailed Description:** 3 groups are allocated using : Aprf Aprf combined with nanochitosan Chitosan Each group will be subjected to tests: Tooth sensibility via EPT (electrical pulp tester)and thermal test Radiolucency in digital radiograph Pain in NRS(6-12-24-72h)for 1 week ### Conditions Module **Conditions:** - Pulpitis - Irreversible ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Intervention: Intervention 1 : Vital pulp therapy using A-PRF as capping material. Intervention 2 : Vital pulp therapy using A-PRF mixed with Nano-Chitosan as capping material. Control/Comparator: Vital pulp therapy using Chitosan as capping material. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A-PRF will be prepared according to Choukroun's technique by drawing whole blood from the median cubital vein into a 10 ml plain plastic test tubes (non-citrated) without the addition of an anticoagulant reagent . To prevent the blood from coagulating, it will be centrifuged immediately using a table top centrifuge at 1500 rpm for 14 minute. **Intervention Names:** - Procedure: PULPOTOMY OF MATURE PERMENANT TEETH **Label:** Advanced Platelet rich fibrin,A-prf,A-PRF scaffold **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** A-PRF will be prepared according to Choukroun's technique by drawing whole blood from the median cubital vein into a 10 ml plain plastic test tubes (non-citrated) without the addition of an anticoagulant reagent . To prevent the blood from coagulating, it will be centrifuged immediately using a table top centrifuge at 1500 rpm for 14 minute then mixed with nanochitosan **Intervention Names:** - Procedure: PULPOTOMY OF MATURE PERMENANT TEETH **Label:** A-prf mixed with nano chitosan **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** he access cavity will be prepared up to the level of pulp chamber floor using sterile round diamond bur size 1 in high-speed hand piece with coolant.Once the pulp has been reached, a sharp sterile excavator should be used to remove the pulp tissue to the level of the radicular/root canal orifices then chitosan will be applied **Intervention Names:** - Procedure: PULPOTOMY OF MATURE PERMENANT TEETH **Label:** chitosan **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - A-prf mixed with nano chitosan - Advanced Platelet rich fibrin,A-prf,A-PRF scaffold - chitosan **Description:** Removal of coronal pulp and expose the orifices to apply the materials with aim to preserve vitality of remaining pulp **Name:** PULPOTOMY OF MATURE PERMENANT TEETH **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Pain assessment using numerical rate scale **Measure:** pain assessment **Time Frame:** 6,12,24,72hours and 7 days postoperative #### Secondary Outcomes **Description:** It includes clinical and radiographic success if either of them failed the case will considered failed. Clinical failure :signs and symptoms of inflammation or infection Radiograph success and failure based on periapical index **Measure:** Clinical and radiographic success **Time Frame:** 1,3,6,9and 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients suffering from Symptomatic irreversible pulpitis in mature mandibular molars only will be involved. * Patients of either gender aged from 15-30. * Tooth should give positive response to cold test. * Haemostasias should be achieved after total pulpotomy. * The tooth is restorable and free from advanced periodontal disease, cracks and splits. * Patients should be free from any systemic disease that may affect normal healing and predictable outcome. * Patients who will agree to the consent and will commit to follow-up period. * Patients with mature root. * Patients with no internal or external resorption and no periapical lesions. * Soft tissues around the tooth are normal with no swelling or sinus tract. Exclusion Criteria: * Patients with immature roots. * Haemostasias after 10 minutes can not be controlled after total pulpotomy * Patients with any systemic disease that may affect normal healing. * Patients with periapical lesions or infections. * Pregnant females. * Patients who could/would not participate in a 6 months follow-up. * Patients with fistula or swelling * Patients with necrotic pulp. * Patients with old age. **Healthy Volunteers:** True **Maximum Age:** 30 Years **Minimum Age:** 15 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** memo_141997@HOTMAIL.COM **Name:** mai S abdelwahed, Bachelor **Phone:** 01068609957 **Phone Ext:** 01010604352 **Role:** CONTACT **Contact 2:** **Email:** MSNAHLARIAD@HOTMAIL.COM **Name:** Hala s abdelwahed, student **Phone:** 01068609957 **Phone Ext:** 01010604352 **Role:** CONTACT #### Locations **Location 1:** **City:** Cairo **Contacts:** ***Contact 1:*** - **Name:** Mai Sheriff Abdelwahed, Researcher - **Role:** CONTACT **Country:** Egypt **Facility:** Future university **State:** Fifth Settlement **Status:** RECRUITING **Zip:** 11813 #### Overall Officials **Official 1:** **Affiliation:** Future University in Egypt **Name:** wael H Kamel, Prof. **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Future University in Egypt **Name:** Hani s sadek, Prof. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003788 - Term: Dental Pulp Diseases - ID: D000014076 - Term: Tooth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14525 - Name: Pulpitis - Relevance: HIGH - As Found: Pulpitis - ID: M6984 - Name: Dental Pulp Diseases - Relevance: LOW - As Found: Unknown - ID: M16831 - Name: Tooth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011671 - Term: Pulpitis ### Intervention Browse Module - Browse Branches - Abbrev: Coag - Name: Coagulants - Abbrev: Lipd - Name: Lipid Regulating Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AnCoag - Name: Anticoagulants - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M25928 - Name: Chitosan - Relevance: LOW - As Found: Unknown - ID: M4244 - Name: Anticoagulants - Relevance: LOW - As Found: Unknown - ID: T377 - Name: Chitosan - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438510 **Acronym:** FULNESS **Brief Title:** The Fulness Trial (Fundus mUcosaL abLation aNd Endoscopic Sleeve Gastroplasty) **Official Title:** A Pilot Study to Evaluate the Impact of Gastric Mucosal Ablation (GMA) of the Fundus With Hybrid Argon Plasma Coagulation (HybridAPC) Combined With Endoscopic Sleeve Gastroplasty (ESG) on Obesity #### Organization Study ID Info **ID:** 5646 #### Organization **Class:** OTHER **Full Name:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Status Module #### Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-30 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-01-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-10-08 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2023-06-15 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS #### Responsible Party **Investigator Affiliation:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS **Investigator Full Name:** BOSKOSKI IVO **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False ### Description Module **Brief Summary:** Ablation of the gastric fundus mucosa with hybrid argon plasma coagulation (HYBRIDAPC) in obese patients undergoing ESG could result in restoration of ghrelin cell function in the gastric fundus. This could improve long-term outcomes in terms of body weight loss and comorbidity reduction in obese patients undergoing ESG. **Detailed Description:** Obesity is one of the most prevalent diseases worldwide with a major impact on the health care system in many countries. Bariatric surgery is currently the first treatment option in obese patients because it offers lasting results on body weight loss and reduces disease-related comorbidities. In recent years, however, endoscopic sleeve gastroplasty (ESG) has emerged as a safe and effective method in treating obese patients. Considering the lower complication rate compared with bariatric surgery and the greater weight loss compared with medical therapy, ESG finds indication as a treatment in cases of class I and II obesity. In cases of BMI \> 40 or higher, bariatric surgery is actually the best option to achieve lasting weight loss but may be burdened by significant morbidity and mortality related to the surgery itself. Ghrelin is a potent oressigenic hormone produced and secreted mainly by the endocrine cells of the gastric glands at the bottom of the stomach and acts in the brain to regulate food intake. Gastric ghrelin plays a key role in glucose metabolism. Obese patients generally show reduced levels of ghrelin and a high percentage of these patients are insulin-resistant, have high circulating levels of insulin, hyperglycemia or diabetes. Through gene expression data and electron microscopy the activity of GPCs (ghrelin-like cells) could be increased in obese patients and correlates with glycemic levels. A positive correlation has been suggested between ghrelin gene expression, glycemic values and body mass index in obese patients. Taken together, these data indicate that ghrelin overproduction by the stomach may be involved in the weight gain and pathogenesis of type 2 diabetes in obese patients. This study aims to demonstrate how further ablation of the gastric fundus mucosa with hybrid argon plasma coagulation (HYBRIDAPC) in obese patients undergoing ESG could result in restoration of ghrelin cell function in the gastric fundus. Indeed, HybridAPC could stimulate fundus stem cells to produce new ghrelin-secreting endocrine cells with normal secretory activity as in lean subjects. Thus normalizing ghrelin signaling to appetite/hunger areas in the brain relayed through the gut brain axis. This could improve long-term outcomes in terms of body weight loss and comorbidity reduction in obese patients undergoing ESG. ### Conditions Module **Conditions:** - Obesity ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### 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:** All patients undergo Endoscopic Sleeve Gastroplasty (ESG) and HybridAPC. ESG will be performed using a flexible endoscopic suturing system (OverStitchTM; Apollo Endosurgery, Austin, TX, USA) connected to a gastroscope. Full- thickness sutures will be placed from the angulus to the gastric fundus using a U-shaped pattern with 2.0 nonabsorbable suture thread. Biopsy tissue will be collected from the gastric fundus and the samples will be fixed for histopathologic examination. HybridAPC is an highly controlled mucosal lift applied by the waterjet function and the subsequent thermal ablation applied by APC. First the fluid cushion is injected into submucosa until a size in the range of 2 - 3 cm is achieved (pressure setting of E20 up to E 30). Second the mucosa is being ablated on the surface of this fluid cushion (30 - 50 Watts, argon gas flow 0.8 L/min) **Intervention Names:** - Procedure: Gastric Mucosal Ablation (GMA) of the fundus with Hybrid Argon Plasma Coagulation (HybridAPC) combined with Endoscopic Sleeve Gastroplasty (ESG) **Label:** Single arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Single arm **Description:** All endoscopic procedures will be performed with the patient in the supine position, under general anesthesia, with endotracheal intubation, in CO2 using a flexible endoscopic suturing system (OverStitchTM; Apollo Endosurgery, Austin, TX, USA) connected to a dual-channel endoscope (GIF-2TH180 or GIF-2TH160; Olympus, Center Valley, PA, USA ). The HybridAPC with submucosal injection and APC will be delivered by ErbeJet®2. ESG will be obtained by placing full-thickness sutures in the body gastric wall, from the angulus to the gastric fundus. Biopsy tissue will be collected from the gastric fundus and the samples will be fixed for histopathologic examination. In the next step HybridAPC to the gastric mucosa of the fundus is applied. **Name:** Gastric Mucosal Ablation (GMA) of the fundus with Hybrid Argon Plasma Coagulation (HybridAPC) combined with Endoscopic Sleeve Gastroplasty (ESG) **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Safety, Tolerability and Efficacy of HybridAPC for gastric mucosa ablation of the fundus in patients undergoing endoscopic sleeve gastroplasty **Measure:** Incidence of Adverse Events **Time Frame:** 18 months **Description:** To assess the additional effect of gastric mucosa ablation in the fundus by HybridAPC upon ESG on total body weight (Kilograms) over time **Measure:** HybridAPC **Time Frame:** 18 months #### Secondary Outcomes **Description:** assess changes in plasma levels of gastric hormones. Fasting blood samples will be taken at baseline and 1, 6 and 12 months follow up visits and stored at -80℃ until assayed. Hormone measurement will be conducted using enzyme-linked immunosorbent assay (ELISA). Assay validation is performed by the manufacturer, testing the precision of the assay and its sensitivity. Ghrelin levels will be measured by ELISA (Lifespan Biosciences, Seattle, WA) with a sensitivity \< 0.094 ng/ml and an intra- and inter-assay precision \<10% and \<10%, respectively. Leptin levels will be measured by ELISA (Lifespan Biosciences, Seattle, WA) with a sensitivity \< 10 pg/ml and an intra- and inter-assay precision \<6.4% and \<7.4%, respectively. GLP-1 levels will be measured by ELISA (Lifespan Biosciences, Seattle, WA) with a sensitivity \< 0.31 ng/ml and an intra- and inter-assay precision \<9.09% and \<8.33%, respectively. **Measure:** Gastric Hormones **Time Frame:** 18 months **Description:** assess quality of life changes at baseline and 1,6,12 months follow up using the BAROS, SF-36 and IWQOL-Lite-CT questionnaire. **Measure:** Life changes **Time Frame:** 18 months **Description:** Comorbidity improvements after ESG and Hybrid APC: Hypertension improvement was considered upon reaching values of PA \< 130/80 mmHg or if antihypertensive therapy was discontinued while maintaining pressure values \<130/80 mmHg. Hyperinsulinemia improvement was considered if the achieved HOMA score was \< 1.8 at any time during follow-up after ESG. Type 2 diabetes mellitus (DMT2) improvement will be considered if the achieved fasting blood glucose will be on values \< 126 mg/dl in at least 2 different measurements or if the glycated hemoglobin value will be \< 6 % or if medical therapy will discontinue. Obstructive sleep apnea syndrome (OSAS) improvement will be considered if nocturnal pO2 \> 92% or if symptoms will disappear without the use of CPAP. **Measure:** Comorbidity **Time Frame:** 18 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 1. Male or females patients in the range of class Class I to Class II obesity (30 ≤ BMI ≤ 39.9). * Age between 18 and 65 years (both inclusive). * Treatment naïve for bariatric surgery or endoscopic bariatric therapy. * Patients that have been evaluated by the local MDT and have indication to ESG. * Willingness to comply with the substantial behavioral modifications program as required by the procedure. * Agree to avoid any use of weight loss medications such as Meridia, Saxenda, Januvia, Xenical, or over the counter weight loss medications or supplements throughout the study. * Women of childbearing potential should have negative urine beta human chorionic gonadotropin (hCG) pregnancy test and must agree to use acceptable contraception methods throughout the study duration. * Able to comply with study requirements and understand and sign the Informed Consent Form. Exclusion Criteria: * Previous upper GI surgery (except uncomplicated cholecystectomy or appendectomy), or other endoscopic bariatric procedures or conditions, * Prior intra-gastric balloon or another gastric implant. * History of a structural or functional disorder of the esophagus or pharynx that may impede passage of the device such as achalasia, stricture/stenosis, esophageal varices, esophageal diverticula, esophageal perforation, severe or intractable gastro-esophageal reflux symptoms while on maximal medical therapy, uncontrolled GERD defined as LA grade C esophagitis or greater. * History of a structural or functional disorder of the stomach including gastric polyps \> 1 cm in size, gastroparesis, gastric ulcer, gastric cancer, chronic gastritis, gastric varices, hiatal hernia (\>4 cm) of axial displacement of the z-line above the diaphragm. * Active H. pylori infection (subjects with active H. pylori may continue with the screening process if they are treated with an appropriate antibiotic regimen, and eradication has been confirmed). * Patients with history of intestinal stricture/stenosis, small bowel or colonic obstruction or any other obstructive disorder of the GI tract such as adhesive peritonitis and/or abdominal adhesions. * Patients with any inflammatory disease (IBD). * Autoimmune disease, including but not limited to celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder. * Active hepatitis, active liver disease, hepatic insufficiency , or cirrhosis. * Untreated/inadequately treated hypothyroidism, defined as an elevated Thyroid-Stimulating Hormone (TSH) level at Screening; if on thyroid hormone replacement therapy, must be on stable dose for at least 6 weeks prior to Screening. * Patients with PCOS (hormonal dis-balances). * Persistent Anemia, defined as Hemoglobin \<10 g/dL. * Significant cardiovascular disease including known history of valvular disease, or myocardial infarction, heart failure, transient ischemic attack or stroke within the last 6 months. * Moderate or severe chronic kidney disease (CKD), with estimated glomerular filtration rate (eGFR) \<45 ml/min/1.73m2 (estimated by MDRD). * Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy or radiotherapy within the past 12 months, who have clinically-significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the subject a poor candidate for clinical trial participation in the opinion of the Investigator. * HbA1c \> 8.5 %. * Patients requiring exogenous insulin. * Use of glucose-lowering drugs for diabetes mellitus treatment with the exception of sulfonylurea (SU), biguanides and sodium dependent glucose co-transporter 2 (SGLT-2) inhibitors. * Coagulopathy, congenital or acquired intestinal telangiectasia. * Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit. * Pregnant or breast-feeding woman. * Patients with history or current abuse of drugs or alcohol. * Patients who are taking medications that cause weight loss such as Meridia, Saxenda, Januvia, Xenical, or over the counter weight loss medications or supplements throughout the study. * Patients who are taking medication that cause weight gain such as anti-depressants * Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study. * Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ivo.boskoski@policlinicogemelli.it **Name:** Ivo Boskoski **Phone:** +390630156580 **Role:** CONTACT **Contact 2:** **Email:** vo.boskoski@policlinicogemelli.it **Name:** Ivo Boskoski **Phone:** +390630156580 **Role:** CONTACT #### Locations **Location 1:** **City:** Rome **Contacts:** ***Contact 1:*** - **Email:** ivo.boskoski@policlinicogemelli.it - **Name:** Ivo Boskoski - **Phone:** +390630156580 - **Role:** CONTACT **Country:** Italy **Facility:** Fondazione Policlinico Universitario A. Gemelli IRCCS **Status:** RECRUITING **Zip:** 00168 #### Overall Officials **Official 1:** **Affiliation:** Fondazione Policlinico Gemelli IRCCS **Name:** ivo boskoski **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000050177 - Term: Overweight - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: HIGH - As Found: Obesity - ID: M26186 - Name: Overweight - Relevance: LOW - As Found: Unknown - ID: M25307 - Name: Overnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009765 - Term: Obesity ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438497 **Brief Title:** The Effect of Different Body Positions and Channel Sheaths on RIRS **Official Title:** The Effect of Different Body Positions and Channel Sheaths on Retrograde Intrarenal Stone Surgery(RIRS) Treatment of Lower Pole Renal Stones: a Randomized Controlled Trial #### Organization Study ID Info **ID:** MRER(84)2024 #### Organization **Class:** OTHER **Full Name:** The First Affiliated Hospital of Guangzhou Medical University ### Status Module #### Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-30 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-23 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-24 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The First Affiliated Hospital of Guangzhou Medical University #### Responsible Party **Investigator Affiliation:** The First Affiliated Hospital of Guangzhou Medical University **Investigator Full Name:** Guohua Zeng **Investigator Title:** Vice president **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Retrograde flexible ureteroscopy (RIRS) is currently the first-line treatment for renal stones \< 2cm. Lower pole renal stones(LPS) are a difficult problem for urologists. The flexible negative pressure suction ureteral sheath(f-UAS) can facilitate RIRS to flush out the fragments and dust in time, and provide a clear vision and reduce the renal pelvis pressure(RPP) during operation.Standard lithotomy position is the most commonly used position for RIRS. Besides, T-tilt position is also available for RIRS in special cases. Investigators were inspired by this and proposed the lateral position, which is available in cases of LPS.In long-term practice, investigators have found that the change of position and the use of f-UAS can improve stone-free rate(SFR). Investigators aimed to conduct a prospective randomized controlled trial to compare the SFR of different positions and different ureteral sheaths. **Detailed Description:** Urolithiasis was one of the most frequently noted diseases in urology clinic, with an incidence ranged from 5 to 15% around the world. Retrograde flexible ureteroscopy (RIRS) is currently the first-line treatment for renal stones \< 2cm in size. Lower pole renal stones(LPS) are a difficult problem for urologists. The inborn sharp infundibular-pelvic angle (IPA) designated an inferior stone-free rate(SFR) of 65-82.5% in LPS when compared to middle and/or upper pole stone. The flexible negative pressure suction ureteral sheath(f-URS) can facilitate RIRS to flush out the fragments and dust in time, and provide a clear vision and reduce the renal pelvis pressure(RPP) during operation. Therefore, in cases of LPS, f-URS combined with RIRS may show advantages. However, there is currently a lack of relevant prospective randomized controlled studies. Standard lithotomy position is the most commonly used position for RIRS. Besides the standard lithotomy position, other positions, such as the T-tilt position, are also available for RIRS in special cases. Investigators were inspired by this and proposed the lateral position, which is available for RIRS in cases of LPS.Theoretically, in standard lithotomy position, the renal pelvis and renal calyces were mostly distributed in a '-\<' shaped structure on the horizontal plane. However, the renal pelvis and renal calyxes would be stood up in a 'Y'-shaped structure when patients laid in lateral position. And gravity will make the calyceal stones at the dome fall into the renal pelvis naturally during the lithotripsy. In long-term clinical practice, researchers have found that the change of position and the use of f-UAS can improve SFR. The investigators aimed to conduct a prospective randomized controlled trial to compare the SFR of different positions and different ureteral sheaths. ### Conditions Module **Conditions:** - Urolithiasis **Keywords:** - RIRS - lower pole renal stones - stone-free rate - ureteral access sheath - flexible negative-pressure - lateral position ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In group 1, patients were placed on operating table in lateral position. A flexible negative-pressure suction ureteric access sheath (f-UAS) is placed under the pelvi-ureteral junction (PUJ) in RIRS. **Intervention Names:** - Procedure: RIRS with f-UAS, lateral position **Label:** RIRS with f-UAS, lateral position **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** In group 2, patients were placed on operating table in lithotomy position. A flexible negative-pressure suction ureteral access sheath (f-UAS) is placed under the pelvi-ureteric junction (PUJ) in RIRS. **Intervention Names:** - Procedure: RIRS with f-UAS, lithotomy position **Label:** RIRS with f-UAS, lithotomy position **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** In group 3, patients were placed on operating table in lithotomy position. A traditional ureteral access sheath (UAS) is placed under the pelvi-ureteric junction (PUJ) in RIRS. **Intervention Names:** - Procedure: RIRS with traditional UAS, lithotomy position **Label:** RIRS with traditional UAS, lithotomy position **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - RIRS with f-UAS, lateral position **Description:** In this intervention, patients were placed on operating table in lateral position. The coronal plane of the patient body was perpendicular to the operating table. The upper limbs were extended and fxed with brackets. A f-UAS is placed under the pelvi-ureteric junction (PUJ) in RIRS. The tip of the UAS has good flexibility and deformability. It can passively bend with the bending of the flexible ureteroscope (f-URS). **Name:** RIRS with f-UAS, lateral position **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - RIRS with f-UAS, lithotomy position **Description:** In this intervention, patients were placed on operating table in lithotomy position. This position is common and standard. A f-UAS is placed under the pelvi-ureteric junction (PUJ) in RIRS. The tip of the UAS has good flexibility and deformability. It can passively bend with the bending of the flexible ureteroscope (f-URS). **Name:** RIRS with f-UAS, lithotomy position **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - RIRS with traditional UAS, lithotomy position **Description:** In this intervention, patients were placed on operating table in lithotomy position. This position is common and standard. **Name:** RIRS with traditional UAS, lithotomy position **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** A low-dose and ultrathin 2-mm spiral CT was performed at 1 day postoperatively for evaluation of fnal SFR. Stone-free status was defined as no fragments observed or clinically insignifcant residual fragments (CIRF)\<2 mm. **Measure:** Stone-free rate **Time Frame:** 1 day **Description:** A low-dose and ultrathin 2-mm spiral CT was performed at 1 month postoperatively for evaluation of fnal SFR. Stone-free status was defined as no fragments observed or clinically insignifcant residual fragments (CIRF)\<2 mm. **Measure:** Stone-free rate **Time Frame:** 1 month #### Secondary Outcomes **Description:** Surgery duration, minutes **Measure:** Operative time **Time Frame:** During surgery **Description:** Change of hemoglobin level 1 day after surgery comparing to pre-operative value, g/L **Measure:** Hemoglobin drop **Time Frame:** 1 day after surgery **Description:** Duration of hospital stay after surgery, days **Measure:** Hospital stay **Time Frame:** 1 week **Description:** Complication is defined as any adverse event occurred intraoperatively or ≤1 month postoperatively, including intraoperative bleeding, postoperative pain and so on.The investigator will invaluate perioperative complications by modified Clavien system **Measure:** Complication rate **Time Frame:** 1 month after sugery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * LPS with a diameter of 10-20 mm * American Society of Anesthesiologists(ASA) score Ⅰ,Ⅱ and Ⅲ * Adult patients Exclusion Criteria: * Ureteric stricture * Urethral deformity * Renal malformation, including horseshoe kidney, ectopic kidney and transplanted kidney * Pregnancy * Multiple stones in diferent calyces, including upper pole and middle pole **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** gzgyzgh@vip.tom.com **Name:** Guohua Zeng, Ph.D and M.D **Phone:** +8613802916676 **Role:** CONTACT **Contact 2:** **Email:** gzgyzhongwen@163.com **Name:** Wen Zhong, Ph.D and M.D **Phone:** +8613631320020 **Role:** CONTACT #### Locations **Location 1:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Email:** gzgyzhongwen@163.com - **Name:** Zhong Wen, Ph.D & MD. - **Phone:** +8613631320020 - **Role:** CONTACT **Country:** China **Facility:** Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University **State:** Guangdong **Status:** RECRUITING **Zip:** 510230 ## 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 ### 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 ### Condition Browse Module - Browse Leaves - ID: M27103 - Name: Urolithiasis - Relevance: HIGH - As Found: Urolithiasis - ID: M10693 - Name: Kidney Calculi - Relevance: LOW - As Found: Unknown - ID: M27126 - Name: Nephrolithiasis - Relevance: LOW - As Found: Unknown - ID: M5399 - Name: Calculi - Relevance: LOW - As Found: Unknown - ID: M17295 - Name: Urinary Calculi - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000052878 - Term: Urolithiasis ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438484 **Brief Title:** The Challenges of Evidence-based Prehabilitation in a Real-life Context for Patients Preparing for Colorectal Surgery **Official Title:** The Challenges of Evidence-based Prehabilitation in a Real-life Context for Patients Preparing for Colorectal Surgery - a Cohort Study and Multiple Case Analysis #### Organization Study ID Info **ID:** NUTNS #### Organization **Class:** OTHER **Full Name:** Nij Smellinghe Hosptial ### Status Module #### Completion Date **Date:** 2023-06-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-30 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-06-30 **Type:** ACTUAL #### Start Date **Date:** 2023-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Nij Smellinghe Hosptial #### Responsible Party **Investigator Affiliation:** Nij Smellinghe Hosptial **Investigator Full Name:** Aletta Danielle Talen **Investigator Title:** Mac clinical health scientist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Background: Multimodal prehabilitation programs are effective in reducing complications after colorectal surgery in patients with high risk of postoperative complications due to low aerobic capacity and/or malnutrition. However, high implementation fidelity is needed to achieve these effects in real-life practice. Therefore, this study aimed to investigate the implementation fidelity of an evidence-based prehabilitation program in the real-life context of a regional hospital. Methods: In this observational cohort study with multiple case analysis, we enrolled all patients who underwent surgery for colorectal cancer from January 2023 to June 2023, in one Dutch peripheral hospital. Patients meeting criteria for low aerobic capacity or malnutrition were advised to participate in a personalized prehabilitation program. Implementation fidelity was investigated on four domains; 1) coverage (participation rate), 2) duration (number of days following the prehabilitation program), 3) content (delivery of prescribed intervention modalities), and 4) frequency (attendance of sessions and compliance with prescribed parameters). An aggregated percentage of content and frequency was calculated to determine overall adherence. The intended outcomes were improvement in preoperative aerobic capacity and malnutrition, and improved postoperative recovery (i.e., reducing complications, length of stay, and time to functional recovery). **Detailed Description:** Study design and patients This observational cohort study was conducted from January 2023 to June 2023 with case analysis on the high-risk patients following the prehabilitation program in Nij Smellinghe (NS). The study was approved by the Local Ethic Committee of NS. The first author was a physiotherapist, who acted as an embedded scientist in the colorectal pathway25. For the period of this study, only one physiotherapist and dietitian performed the prehabilitation program to prevent provider-dependent bias. All patients, both high-risk and low-risk, of 18 years or older scheduled for elective colorectal surgery in NS were asked for their informed consent to be included in the cohort. No exclusion criteria were applied. The STrengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline for reporting observational studies was followed26. Study setting NS is a regional hospital with 339 beds in The Netherlands, where annually 150 patients undergo colorectal surgery27. NS is an innovative hospital in the field of perioperative care and the Enhanced Recovery After Surgery (ERAS) protocol has been implemented into usual care since 201828. In January 2023, following new scientific insights, an evidence-based multimodal prehabilitation program was implemented in the colorectal pathway. This pathway included assessment of patients on their risk of postoperative complications and offering a multimodal prehabilitation program for high-risk patients. Preoperative risk assessment When patients were indicated for colorectal surgery, a physiotherapist and dietitian conducted risk assessment for postoperative complications. Patients meeting criteria for low aerobic capacity and/or high risk of malnutrition were advised to participate in a personalized prehabilitation program2,29. The physiotherapist assessed aerobic capacity. Aerobic capacity was measured by the cardiopulmonary exercise test (CPET) or modified steep ramp test (SRT), following the protocol of previous research on preoperative risk assessment2,15,30. Patients with a low aerobic capacity, indicated by a work at peak exercise achieved at the modified SRT ≤1.5W/kg or an oxygen uptake at the VAT ≤11mL/kg/min at the CPET, were indicated as high-risk patients. The dietitian evaluated risk of malnutrition by using the Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF). Based on the Global Leadership Initiative on Malnutrition (GLIM) criteria, patients were diagnosed with malnutrition, thus indicating the nutrition-modality of prehabilitation31. According to the GLIM-criteria, malnutrition is defined as the presence of one phenotypic criterion (non-volitional weight loss, low body mass index, and reduced muscle mass) and one etiologic criterion (reduced food intake or assimilation, and inflammation or disease burden)32. Muscle mass and body composition was assessed with the bioelectrical impedance analysis (BIA) (Bodygram Plus, Akern, Italy). Patients with high-risk profile: multimodal prehabilitation program High-risk patients followed an evidence-based multimodal prehabilitation program for five weeks, incorporating modalities tailored to address their impairments2,12,15. Patients performed physical exercise training and/or received dietary counseling for five weeks, provided by a trained physiotherapist and dietitian (both \>15 years experience). The physical exercise training consisted of high-intensity interval training (HIIT) three times a week and functional strengthening exercises. Patients visited the hospital two times a week and performed home exercise training five times a week on a stationary cycle ergometer (Corival Home+, Lode BV, Groningen, The Netherlands). The dietary intervention consisted of optimization of energy and protein intake, optimization of timing of eating protein-rich products, and if necessary additional protein and vitamin supplements. Individual protein requirements were set at 1.5-1.9 g/kg fat free mass. Patients used the eiFIT-application or a food diary to track their protein intake33. Treating patients with low hemoglobin levels, offering alcohol- and smoking cessation interventions, and giving psychological support were also elements of the prehabilitation program in NS. However, this is already part of usual care since implementation of the ERAS-protocol and therefore not specifically evaluated in this study. A detailed description of the complete pathway is provided in Appendix 1. Statistical analysis All data were analyzed using descriptive statistics. For patient characteristics continuous data were tested for normality by the Shapiro-Wilk test and QQ-plot. Median and interquartile range (IQR) or mean and standard deviation were reported accordingly. To report the fidelity of the prehabilitation program, absolute values and percentages were given. To prevent selection bias, NS reimbursed the expenses of prehabilitation for people who otherwise could not afford it, as insurance companies did not reimburse prehabilitation in The Netherlands during the study period. Data were analyzed using R Framework 4.2.2 for macOS (version 2022, Vienna)42. ### Conditions Module **Conditions:** - Colorectal Surgery **Keywords:** - Preoperative Exercise ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 43 **Type:** ACTUAL **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 7 Weeks ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with high aerobic capacity and good nutritional status were given the advice to eat healthy and stay active until surgery. Postoperative data were collected for evaluative purposes. **Label:** Low risk #### Arm Group 2 **Description:** High-risk patients followed an evidence-based multimodal prehabilitation program for five weeks, incorporating modalities tailored to address their impairments. Patients performed physical exercise training and/or received dietary counseling for five weeks, provided by a trained physiotherapist and dietitian (both \>15 years experience). **Intervention Names:** - Behavioral: multimodal prehabilitation program **Label:** High risk ### Interventions #### Intervention 1 **Arm Group Labels:** - High risk **Description:** Patients performed physical exercise training and/or received dietary counseling for five weeks, provided by a trained physiotherapist and dietitian (both \>15 years experience). The physical exercise training consisted of high-intensity interval training (HIIT) three times a week and functional strengthening exercises. Patients visited the hospital two times a week and performed home exercise training five times a week on a stationary cycle ergometer (Corival Home+, Lode BV, Groningen, The Netherlands). The dietary intervention consisted of optimization of energy and protein intake, optimization of timing of eating protein-rich products, and if necessary additional protein and vitamin supplements. Individual protein requirements were set at 1.5-1.9 g/kg fat free mass. Patients used the eiFIT-application or a food diary to track their protein intake. **Name:** multimodal prehabilitation program **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** age(years) **Measure:** patiënt characteristics, age **Time Frame:** january 2023 - june 2023 **Description:** sex (male or female) **Measure:** patiënt characteristics, sex **Time Frame:** january 2023 - june 2023 **Description:** living situation(together or alone) **Measure:** patiënt characteristics, living situation **Time Frame:** january 2023 - june 2023 **Description:** body mass index(BMI) **Measure:** patiënt characteristics, BMI **Time Frame:** january 2023 - june 2023 **Description:** comorbidities(age-adjusted Charlson Comorbidity index) **Measure:** patiënt characteristics, comorbidities **Time Frame:** january 2023 - june 2023 **Description:** haemoglobin level(mmol/L) **Measure:** patiënt characteristics, hb **Time Frame:** january 2023 - june 2023 **Description:** tumor location(rectal or colon) **Measure:** patiënt characteristics, tumor location **Time Frame:** january 2023 - june 2023 **Description:** ASA score(I-IV) **Measure:** patiënt characteristics, ASA **Time Frame:** january 2023 - june 2023 **Description:** surgical procedure (open or laparoscopic) **Measure:** patiënt characteristics, surgical procedure **Time Frame:** january 2023 - june 2023 #### Primary Outcomes **Description:** Coverage was defined as 'the participation rate in the innovation by the intended audience' and was determined as the percentage of eligible patients who were assessed and able to follow the suitable prehabilitation pathway. Reasons for drop-out and non-participation were reported. **Measure:** Coverage **Time Frame:** january 2023 - june 2023 **Description:** , which can be subdivided into coverage, duration, content, and frequency. Duration was measured by the number of days between assessment and surgery and should be at least thirty days. **Measure:** Duration **Time Frame:** january 2023 - june 2023 **Description:** Content was measured by the number of different components of the intervention delivered. **Measure:** Content **Time Frame:** january 2023 - june 2023 **Description:** Frequency was measured by the percentage of times when the training intensity as prescribed, time, and the days on which nutritional requirements were achieved **Measure:** Frequency **Time Frame:** january 2023 - june 2023 #### Secondary Outcomes **Description:** Preoperative aerobic capacity was measured before and after the prehabilitation program by the Steep Ramp Test. The maximum wattage will be reported. **Measure:** Preoperative aerobic capacity **Time Frame:** january 2023 - june 2023 **Description:** Preoperative risk of malnutrition was measured before and after the prehabilitation program by the the patient generated subjective global assessment short form (PG-SGA SF). This is a validated instrument used by dietitians for the assessment of malnutrition and monitoring of interventions. A low score means a low risk of malnutrition. **Measure:** Preoperative nutritional status **Time Frame:** january 2023 - june 2023 **Description:** The occurrence of complications was reported, and complications were categorized according to the Clavien-Dindo classification. **Measure:** Complications **Time Frame:** january 2023 - june 2023 **Description:** Length of stay was defined as days admitted to the hospital2. **Measure:** Length of stay **Time Frame:** january 2023 - june 2023 **Description:** Time to recovery of physical functioning was measured by the modified Iowa level of assistance scale (mILAS) and was reported as time in days between surgery and full inhospital recovery of physical functioning. **Measure:** Time to recovery of physical functioning **Time Frame:** january 2023 - june 2023 **Description:** Facilitation strategies are strategies to optimize implementation aimed at barriers known from previous research, which are logistical and financial challenges. The physiotherapist, dietitian and embedded researcher documented their observations on influencing factors in a logbook. **Measure:** Facilitation strategies **Time Frame:** january 2023 - june 2023 **Description:** Practitioner responsiveness is defined as 'engagement to the intervention'. Practitioner responsiveness was measured by a short questionnaire for the physiotherapist and dietitian based on a measurement instrument for determinants of innovation at the end of the study period. Participant responsiveness was measured by a short questionnaire after finishing their prehabilitation program, based on questionnaires in comparable studies **Measure:** Practitioner responsiveness **Time Frame:** january 2023 - june 2023 **Description:** Participant responsiveness is defined as 'engagement to the intervention'. Participant responsiveness was measured by a short questionnaire after finishing their prehabilitation program, based on questionnaires in comparable studies **Measure:** Participant responsiveness **Time Frame:** january 2023 - june 2023 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * a patient must be awaiting CRC surgery in NS * be 18 years or older Exclusion Criteria: * Patient data will only be excluded if they do not permit the usage of their data. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** patients following the prehabilitation program in Nij Smellinghe ### Contacts Locations Module #### Locations **Location 1:** **City:** Drachten **Country:** Netherlands **Facility:** Nij Smellinghe hospital **State:** Friesland **Zip:** 9202 NN #### Overall Officials **Official 1:** **Affiliation:** Nij Smellinghe **Name:** Aletta Danielle Talen, drs **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Data are pseudonymized and stored in a secured environment. The data that support the findings of this study are available from Nij Smellinghe, but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of Nij Smellinghe. **IPD Sharing:** UNDECIDED ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M17558 - Name: Vitamins - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438471 **Brief Title:** Novel Soluble Epoxide Hydrolase Inhibitor for Neuropathic Pain in Patients With Spinal Cord Injury **Official Title:** Development of a Novel Soluble Epoxide Hydrolase Inhibitor as a Strategy for Treating Neuropathic Pain in Patients With SCI #### Organization Study ID Info **ID:** EC5026-1-04 #### Organization **Class:** INDUSTRY **Full Name:** EicOsis Human Health Inc. ### Status Module #### Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-30 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-24 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** EicOsis Human Health Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this clinical trial is to evaluate safety and tolerability of multiple oral doses of EC5026 in male and female patients with neuropathic pain due to spinal cord injury. The main question it aims to answer is whether EC5026 is safe and well tolerated in SCI patients with neuropathic pain. In addition, this trial will also study the effects of EC5026 on pain. Researchers will compare EC5026 to placebo. Participants will be asked to: * Take EC5026 or placebo in a masked fashion, once daily, for 14 consecutive days. * Undergo physical exams, vital signs assessments, ECGs, and blood draws * Complete assessments of pain, sleep, functional status, and perception of change **Detailed Description:** EC5026 has been shown to be effective in preclinical pain models of pain, including inflammatory and neuropathic pain subtypes. Three Phase 1 studies of EC5026 have been conducted in healthy volunteers; a Phase 1a Single Ascending Dose (SAD) study, a Phase 1a Fed-Fasted study, and a Phase 1b Multiple Ascending Dose (MAD) study. The Phase 1b MAD study evaluated the safety, tolerability, and PK of 2 sequential ascending dose regimens of oral EC5026, administered once daily for 7 consecutive days, in healthy volunteers. The present study will evaluate the safety and tolerability, as well as target engagement and pharmacodynamics, of EC5026 administered as multiple doses in subjects with neuropathic pain due to spinal cord injury. ### Conditions Module **Conditions:** - Spinal Cord Injuries - Neuropathic Pain ### 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:** 36 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Multiple oral doses of EC5026 **Intervention Names:** - Drug: EC5026 oral tablet **Label:** EC5026 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Matching oral placebo **Intervention Names:** - Drug: Placebo oral tablet **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - EC5026 **Description:** There will be two ascending dose regimens of EC5026, which will be administered over two consecutive Treatment Periods. During each Treatment Period, EC5026 will be administered orally once daily for 7 consecutive days, with a loading dose on Day 1 and a maintenance dose on Days 2-7 of each treatment period. All study subjects will be enrolled in both Treatment Periods and will receive both dose regimens consecutively, for a total duration of 14 days. Oral doses of EC5026 tested in each Treatment Period: Treatment Period 1: 6 mg loading dose on Day 1 / 2 mg Maintenance dose on Days 2-7 Treatment Period 2: 8 mg loading dose on Day 8 / 4 mg Maintenance dose on Days 9-14 **Name:** EC5026 oral tablet **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Participants will be administered a matching oral placebo for 14 consecutive days. **Name:** Placebo oral tablet **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Standard validated EC5026 measurement platform will be used. **Measure:** Effects of 2 ascending multiple dose regimens of EC5026 versus placebo on plasma levels of EC5026 **Time Frame:** 30 days **Description:** Standard validated oxylipin measurement platform will be used. **Measure:** Effects of 2 ascending multiple dose regimens of EC5026 versus placebo on oxylipin biomarkers. **Time Frame:** 30 days **Description:** Target engagement biomarkers will include epoxi fatty acids(EpFA):diol ratio **Measure:** Effects of 2 ascending multiple dose regimens of EC5026 versus placebo on target engagement biomarkers. **Time Frame:** 30 days **Measure:** Effects of 2 ascending multiple dose regimens of EC5026 versus placebo on inflammatory biomarkers: C-Reactive Protein **Time Frame:** 30 days **Measure:** Effects of 2 ascending multiple dose regimens of EC5026 versus placebo on inflammatory biomarkers: IL-6 **Time Frame:** 30 days **Measure:** Effects of 2 ascending multiple dose regimens of EC5026 versus placebo on inflammatory biomarkers: TNF alpha **Time Frame:** 30 days **Description:** The average daily pain will be measured as part of the Brief Pain Inventory - Short Form (BPI-SF). This scale uses a 11-point numeric rating scale (NRS) from 0 to 10 to rate pain from "no pain" (score = 0) to "pain as bad as you can imagine" (score = 10). **Measure:** Change in average daily pain from baseline to Day 4 **Time Frame:** 4 days **Description:** The average daily pain will be measured as part of the Brief Pain Inventory - Short Form (BPI-SF). This scale uses a 11-point numeric rating scale (NRS) from 0 to 10 to rate pain from "no pain" (score = 0) to "pain as bad as you can imagine" (score = 10). **Measure:** Change in average daily pain from baseline to Day 8 **Time Frame:** 8 days **Description:** The average daily pain will be measured as part of the Brief Pain Inventory - Short Form (BPI-SF). This scale uses a 11-point numeric rating scale (NRS) from 0 to 10 to rate pain from "no pain" (score = 0) to "pain as bad as you can imagine" (score = 10). **Measure:** Change in average daily pain from baseline to Day 11 **Time Frame:** 11 days **Description:** The average daily pain will be measured as part of the Brief Pain Inventory - Short Form (BPI-SF). This scale uses a 11-point numeric rating scale (NRS) from 0 to 10 to rate pain from "no pain" (score = 0) to "pain as bad as you can imagine" (score = 10). **Measure:** Change in average daily pain from baseline to Day 14 **Time Frame:** 14 days **Description:** The average daily pain will be measured as part of the Brief Pain Inventory - Short Form (BPI-SF). This scale uses a 11-point numeric rating scale (NRS) from 0 to 10 to rate pain from "no pain" (score = 0) to "pain as bad as you can imagine" (score = 10). **Measure:** Change in average daily pain from baseline to Day 21 **Time Frame:** 21 days **Description:** The average daily pain will be measured as part of the Brief Pain Inventory - Short Form (BPI-SF). This scale uses a 11-point numeric rating scale (NRS) from 0 to 10 to rate pain from "no pain" (score = 0) to "pain as bad as you can imagine" (score = 10). **Measure:** Change in average daily pain from baseline to Day 28 **Time Frame:** 28 days **Description:** The worst daily pain will be measured as part of the Brief Pain Inventory - Short Form (BPI-SF). This scale uses a 11-point numeric rating scale (NRS) from 0 to 10 to rate pain from "no pain" (score = 0) to "pain as bad as you can imagine" (score = 10). **Measure:** Change in worst daily pain from baseline to Day 4. **Time Frame:** 4 days **Description:** The worst daily pain will be measured as part of the Brief Pain Inventory - Short Form (BPI-SF). This scale uses a 11-point numeric rating scale (NRS) from 0 to 10 to rate pain from "no pain" (score = 0) to "pain as bad as you can imagine" (score = 10). **Measure:** Change in worst daily pain from baseline to Day 8. **Time Frame:** 8 days **Description:** The worst daily pain will be measured as part of the Brief Pain Inventory - Short Form (BPI-SF). This scale uses a 11-point numeric rating scale (NRS) from 0 to 10 to rate pain from "no pain" (score = 0) to "pain as bad as you can imagine" (score = 10). **Measure:** Change in worst daily pain from baseline to Day 11. **Time Frame:** 11 days **Description:** The worst daily pain will be measured as part of the Brief Pain Inventory - Short Form (BPI-SF). This scale uses a 11-point numeric rating scale (NRS) from 0 to 10 to rate pain from "no pain" (score = 0) to "pain as bad as you can imagine" (score = 10). **Measure:** Change in worst daily pain from baseline to Day 14. **Time Frame:** 14 days **Description:** The worst daily pain will be measured as part of the Brief Pain Inventory - Short Form (BPI-SF). This scale uses a 11-point numeric rating scale (NRS) from 0 to 10 to rate pain from "no pain" (score = 0) to "pain as bad as you can imagine" (score = 10). **Measure:** Change in worst daily pain from baseline to Day 21. **Time Frame:** 21 days **Description:** The worst daily pain will be measured as part of the Brief Pain Inventory - Short Form (BPI-SF). This scale uses a 11-point numeric rating scale (NRS) from 0 to 10 to rate pain from "no pain" (score = 0) to "pain as bad as you can imagine" (score = 10). **Measure:** Change in worst daily pain from baseline to Day 28. **Time Frame:** 28 days **Description:** The Neuropathic Pain Symptom Inventory (NPSI) is a questionnaire that assesses neuropathic pain. The total score on the NPSI ranges from 0 to 100, with higher scores indicating more severe pain. **Measure:** Change in Neuropathic Pain Symptom Inventory (NPSI) total score from baseline to Day 4. **Time Frame:** 4 days **Description:** The Neuropathic Pain Symptom Inventory (NPSI) is a questionnaire that assesses neuropathic pain. The total score on the NPSI ranges from 0 to 100, with higher scores indicating more severe pain. **Measure:** Change in Neuropathic Pain Symptom Inventory (NPSI) total score from baseline to Day 8. **Time Frame:** 8 days **Description:** The Neuropathic Pain Symptom Inventory (NPSI) is a questionnaire that assesses neuropathic pain. The total score on the NPSI ranges from 0 to 100, with higher scores indicating more severe pain. **Measure:** Change in Neuropathic Pain Symptom Inventory (NPSI) total score from baseline to Day 11. **Time Frame:** 11 days **Description:** The Neuropathic Pain Symptom Inventory (NPSI) is a questionnaire that assesses neuropathic pain. The total score on the NPSI ranges from 0 to 100, with higher scores indicating more severe pain. **Measure:** Change in Neuropathic Pain Symptom Inventory (NPSI) total score from baseline to Day 14. **Time Frame:** 14 days **Description:** The Neuropathic Pain Symptom Inventory (NPSI) is a questionnaire that assesses neuropathic pain. The total score on the NPSI ranges from 0 to 100, with higher scores indicating more severe pain. **Measure:** Change in Neuropathic Pain Symptom Inventory (NPSI) total score from baseline to Day 21. **Time Frame:** 21 days **Description:** The Neuropathic Pain Symptom Inventory (NPSI) is a questionnaire that assesses neuropathic pain. The total score on the NPSI ranges from 0 to 100, with higher scores indicating more severe pain. **Measure:** Change in Neuropathic Pain Symptom Inventory (NPSI) total score from baseline to Day 28. **Time Frame:** 28 days #### Primary Outcomes **Description:** All AEs reported or observed during the study will be recorded on the electronic case report forms (eCRF). Information to be collected includes drug treatment, type of event, time of onset, dosage, investigator-specified assessment of severity and relationship to study drug, time of resolution of the event, seriousness, any required treatment or evaluations, and outcome. Any AEs resulting from concurrent illnesses, reactions to concurrent illnesses, reactions to concurrent medications, or progression of disease states must also be reported. All AEs will be followed until they are resolved, stable, or judged by the investigator to be not clinically significant. The Medical Dictionary for Regulatory Activities will be used to code all AEs. **Measure:** Incidence of Adverse Events (AEs) and Serious Adverse Events (SAE) [Safety and Tolerability] **Time Frame:** 30 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Each subject must meet all of the following criteria to be enrolled in this study: 1. Male and female United States Veterans 18 and older. 2. Subjects must be willing to provide written informed consent to participate in the study. 3. Subjects must be able to provide own transportation to study site every day for the duration of the study. 4. Subjects must have a complete or incomplete C2-T12 SCI of at least 12 months duration, with below-level neuropathic pain identified by the International Spinal Cord Injury Pain (ISCIP) classification criteria. 5. Subjects must have completed a minimum of 6 of the 7 daily assessments for average and worst daily pain prior to final screening, using an 11-point numerical rating scale (NRS) for average daily pain intensity, and the arithmetic average daily SCI neuropathic pain score must be ≥4 and ≤9, with a standard deviation less than or equal to 1.2. Daily pain assessment screenings will be done over the phone with the study coordinator after informed consent is obtained. 6. Subjects must be in overall stable condition, as determined by pre-study medical history, physical examination, clinical laboratory tests, and 12-lead ECG measurements. 7. Subjects must have normal or not clinically significant clinical laboratory test results, as determined by the study investigator, including coagulation panel, blood cell counts, comprehensive metabolic panel analytes, and creatinine clearance (60 cm3/min or greater). Clinical laboratory tests results that are consistent with known, stable comorbidities will be allowed as long as the comorbidities do not represent an exclusion criteria per se. 8. Subjects must have a negative screening for HIV, Hepatitis C, and Hepatitis B within 30 days of randomization. 9. Subjects must have a negative urinary drug screen (UDS) for illicit drugs (marihuana/THC are allowed) and serum ethanol level \<80 mg/dL. 10. Male subjects who are not surgically sterile (vasectomized) and their female sexual partners must agree to use contraception during the study period and for 2 months afterward. 11. Male subjects must not donate sperm during the study and for 12 months after receiving the last dose of study drug. 12. Female subjects must be non-pregnant, non-lactating, and either postmenopausal for at least 1 year, or surgically sterile (bilateral tubal ligation ('clipping or tying tubes' or hysterectomy) for at least 3 months, or they must agree to use a highly effective contraception method (less than 1 pregnancy per 100 people using the method for one year), from 28 days and/or their last confirmed menstrual period prior to study enrollment (whichever is longer) until 2 months after clinic discharge. Exclusion Criteria: Subjects meeting any of the following criteria will be excluded from the study: 1. Ventilator-dependent subjects, with the exception of nocturnal use of CPAP or BiPAP. 2. Subjects with pain that is not present every day (chronic) or where the pain description does not have a classic neuropathic phenotype. 3. Subjects with other chronic neuropathic pain conditions, including painful diabetic neuropathy, HIV-associated neuropathic pain, chemotherapy or ethanol-associated neuropathy. 4. Subjects with other pain syndromes that may confound assessment or self-evaluation of the SCI neuropathic pain. 5. Subjects with only negative symptoms, defined as numbness without clear evidence of spontaneous pain, either constant or episodic. 6. Subjects using opioid medications on a regular basis or pro re nata (PRN). Non-opioid pain medications will be allowed if at a fixed stable dose for more than 1 month prior to Screening with no anticipation of the dose changing during the study, and if they do not interfere with the subject's ability to rate pain as per Investigator's discretion. Allowed non-opioid medications include gabapentin, pregabalin, duloxetine, acetaminophen, ibuprofen, celecoxib, meloxicam, other antidepressants including amitriptyline and other antiepileptics, as well as topical capsaicin and topical lidocaine. 7. Subjects with active Hepatitis A, Hepatitis B and/or Hepatitis C. 8. Subjects with any clinically unstable or significant cardiovascular (including acute coronary syndrome within the prior year to Screening), renal, hepatic, respiratory, gastrointestinal, hematological, endocrine, or infectious disease (including HIV infection). 9. Subjects with clinically significant abnormalities on screening vital signs, laboratory tests, and/or ECG. Subjects with poor venous access will also be excluded. 10. Subjects with a history of disorders of the hypothalamic-pituitary-adrenal axis, including adrenal insufficiency and Cushing's. 11. Subjects who have used chemotherapy agents, or who have a personal history of cancer or cancer in first degree relatives suggestive of elevated cancer risk, other than nonmetastatic skin cancer that has been completely excised, within 5 years prior to Screening. 12. Subjects with a history of bacterial, fungal, or viral infection requiring treatment with antibiotics, antifungal agents, or antivirals within 1 month prior to randomization. 13. Subjects who have used (within 14 days of randomization) or plan on using during the duration of the study any prescription or over-the-counter drugs that are moderate-strong CYP3A4 inducers or inhibitors. 14. Subjects who have used (within 14 days of randomization) or plan on using during the duration of the study any dietary aids, supplements, or foods that are moderate-strong CYP3A4 inhibitors (e.g., grapefruit juice). 15. Subjects with difficulty in swallowing oral medications. 16. Subjects with serious psychosocial comorbidities as determined by the Investigator. 17. Subjects with current cognitive or major psychiatric disorders, or any other condition that could interfere with compliance with study procedures. 18. Subjects with a positive drug or alcohol test (\>80 mg/dL) during Screening and/or admission (a positive THC test will be allowed as long as it consists of minimal social use, per discretion of Investigator), or with a recent history of binge drinking within 1 week of randomization. 19. Subjects who have used any other investigational drug within 1 month prior to enrollment. If the investigational drug is known to have a long half life, a longer washout period will be done. 20. Subjects with a presence or history of active gastrointestinal disorder, including esophageal or gastroduodenal ulceration, or renal, hepatic, or coagulant disorder within 1 month prior to enrollment. 21. Subjects with a family history of significant cardiac disease (i.e., sudden death in first degree relative; myocardial infarction before the age of 50). 22. Subjects with confirmed COVID-19, or suspected COVID-19 (e.g., developed symptoms of a respiratory infection such as cough, sore throat, shortness of breath, or fever, but did not get tested for COVID-19) within 30 days of randomization. 23. Subjects who have received a COVID-19 vaccine within 30 days of randomization or are planning on receiving it during the study duration. 24. Subjects who are not Veterans **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** LCARBONE@augusta.edu **Name:** Laura Carbone, MD, MS, FACP **Phone:** 706-721-6909 **Role:** CONTACT #### Locations **Location 1:** **City:** Augusta **Contacts:** ***Contact 1:*** - **Email:** LCARBONE@augusta.edu - **Name:** Laura Carbone, MD, MS, FACP - **Phone:** 706-721-6909 - **Role:** CONTACT **Country:** United States **Facility:** AU Medical Center **State:** Georgia **Status:** RECRUITING **Zip:** 30912 #### Overall Officials **Official 1:** **Affiliation:** EicOsis Human Health Inc. **Name:** William K Schmidt, PhD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014947 - Term: Wounds and Injuries - ID: D000013118 - Term: Spinal Cord Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000020196 - Term: Trauma, Nervous System - ID: D000010523 - Term: Peripheral Nervous System Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M15916 - Name: Spinal Cord Injuries - Relevance: HIGH - As Found: Spinal Cord Injury - ID: M12381 - Name: Neuralgia - Relevance: HIGH - As Found: Neuropathic Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - 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: M22023 - Name: Trauma, Nervous System - Relevance: LOW - As Found: Unknown - ID: M13432 - Name: Peripheral Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013119 - Term: Spinal Cord Injuries - ID: D000009437 - Term: Neuralgia ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438458 **Brief Title:** Effect of Postural Change on Hemoglobin Level in Patients on the Intensive Care Unit **Official Title:** Effect of Postural Change on Hemoglobin Level in Patients on the Intensive Care Unit #### Organization Study ID Info **ID:** NL86966 #### Organization **Class:** OTHER **Full Name:** Deventer Ziekenhuis ### Status Module #### Completion Date **Date:** 2024-10-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-30 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-10-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-17 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Deventer Ziekenhuis #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Monitoring hemoglobin levels (Hb) is important to identify anemia in hospitalized patients. Changes in posture and mobilization efforts, as demonstrated by previous research, can lead to significant shifts in Hb concentrations. This phenomenon has not been studied in ICU patients. This study aims to investigate whether postural changes and mobilisation affect Hb in ICU patients. We hypothesize that significant Hb shifts may occur, potentially leading to misinterpretations of anemia and unnecessary diagnostic and therapeutic workup. Understanding this impact can guide clinical practice and prevent unwarranted interventions. **Detailed Description:** Rationale: Monitoring hemoglobin levels (Hb) is important to identify anemia in hospitalized patients. Changes in posture and mobilization efforts, as demonstrated by previous research, can lead to significant shifts in Hb concentrations. Low Hb levels due to these shifts are termed 'postural pseudoanemia'. This phenomenon has not been studied in ICU patients. Many factors may affect Hb concentrations in ICU patients, including plasma volume shifts, bleeding, repeated phlebotomies, hemolysis, bone marrow suppression and functional iron deficiency. When this leads to significant anemia, patients may be treated with red blood cell transfusions. However, blood transfusions have been associated with adverse reactions and should only be performed for appropriate indications. If postural pseudoanemia occurs in ICU patients this could lead to patient harm through inadvertent investigations and red blood cell transfusions. The occurrence of postural pseudoanemia in ICU patients may differ from previous studies because ICU patients are more frequently immobilized for more prolonged periods. This study aims to investigate whether postural changes affect Hb in ICU patients. We hypothesize that significant Hb shifts may occur, potentially leading to misinterpretations of anemia and unnecessary diagnostic and therapeutic workup. Understanding this impact can guide clinical practice and prevent unwarranted interventions. Objective: Main objective: To assess Hb levels in ICU patients upon a change in posture from supine to upright and following mobilization to a chair. Secondary objectives: To seek correlations between hemoglobin shifts and changes in serum albumin concentrations upon a change in posture from supine to sitting and following mobilization to a chair. To seek correlations between hemoglobin shifts and changes in serum uric acid concentrations upon a change in posture from supine to sitting and following mobilization to a chair. To seek correlations between hemoglobin shifts and levels of CRP and ESR upon a change in posture from supine to sitting and following mobilization to a chair. To compare hemoglobin concentrations following \> 6 hours in supine position at 24 hours with pre-intervention levels for patients remaining in the ICU. Any other changes seen in the lab measurements or vital parameters upon a change in posture? Study design: Prospective uncontrolled interventional study. Study population: Patients \> 18 years old, admitted to the intensive care unit. Intervention: All patients will undergo a change in posture from supine to upright, followed by mobilization to a chair. Main study parameters/endpoints: Relative percentage change in Hb. ### Conditions Module **Conditions:** - Anemia **Keywords:** - Blood composition - Circulatory physiology ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SEQUENTIAL **Intervention Model Description:** Blood samples are taken before and after the interventions ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 24 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Hemoglobin concentration after sitting in bed (passively) for \>30 min, and after mobilization to a chair for \>30 min **Intervention Names:** - Procedure: Postural change from supine to sitting - Procedure: Mobilization to a chair **Label:** Hb in different positions **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Hb in different positions **Description:** Patients go from supine to sitting position in bed (passive) **Name:** Postural change from supine to sitting **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Hb in different positions **Description:** Patients go from the bed to sitting in a chair (active) **Name:** Mobilization to a chair **Type:** PROCEDURE ### Outcomes Module #### Other Outcomes **Description:** Uric acid concentration **Measure:** Uric acid **Time Frame:** 3 hours #### Primary Outcomes **Description:** Hemoglobin concentration **Measure:** Hemoglobin **Time Frame:** 3 hours #### Secondary Outcomes **Description:** Albumin concentration **Measure:** Albumin **Time Frame:** 3 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age over 18 years, of any gender and ethnic background * Admitted to the intensive care unit * Able to give informed consent * Patients with an arterial line as part of their treatment plan. * Patients able to remain seated in chair for at least 30 minutes * Patients able to remain supine overnight for at least 6 hours Exclusion Criteria: * Delirium or inability to give informed consent * Inability to understand written information in Dutch * Patients on artificial ventilation * Orotracheally intubated patients (spontaneous breathing through a tracheostomy cannula is allowed) * Patients treated with noradrenaline \> 0.05 ug/kg/min * Patients treated with argipressin * Patients who received a blood transfusion within 24 hours before measurements * Patients who received \> 3 L of fluids within 24 hours before measurements * Patients who received \> 500 ml of iv fluids within 4 hours of measurements * Severe restlessness or inability to remain supine for 6 hours before initial blood sampling * Patients being treated with diuretics * Patients admitted with: * Decompensated right heart failure * Pulmonary hypertension * Pulmonary embolism * Active bleeding or risk of \>100 ml blood loss * Hematological disorder/malignancy **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** f.steveninckvan@dz.nl **Name:** Alfred L van Steveninck, M.D., Ph.D. **Phone:** +31570535346 **Role:** CONTACT **Contact 2:** **Email:** h.vandenoever@dz.nl **Name:** Huub LA van den Oever, M.D. **Phone:** +31570535346 **Role:** CONTACT #### Locations **Location 1:** **City:** Deventer **Contacts:** ***Contact 1:*** - **Email:** f.steveninckvan@dz.nl - **Name:** Alfred L van Steveninck, M.D., Ph.D. - **Phone:** +31570535346 - **Role:** CONTACT ***Contact 2:*** - **Email:** h.vandenoever@dz.nl - **Name:** Huub LA van den Oever, M.D. - **Phone:** +31570535346 - **Role:** CONTACT **Country:** Netherlands **Facility:** Deventer Hospital **Zip:** 7416SE #### Overall Officials **Official 1:** **Affiliation:** Deventer Ziekenhuis **Name:** Alfred L van Steveninck, M.D., Ph.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** A written request must be sent to the principal investigator. **Description:** Data can be obtained from the principal investigator upon request. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** After preparation of the manuscript. ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4070 - Name: Anemia - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Analg - Name: Analgesics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M207501 - Name: Chrysarobin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438445 **Brief Title:** Effects of Royal Jelly Supplementation in Chronic Kidney Disease **Official Title:** Effects of Royal Jelly Supplementation on Inflammation and Cellular Senescence in Chronic Kidney Disease Patients Under Hemodialysis #### Organization Study ID Info **ID:** Interventional #### Organization **Class:** OTHER **Full Name:** Universidade Federal Fluminense ### Status Module #### Completion Date **Date:** 2024-12-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universidade Federal Fluminense #### 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 this study is to evaluate the effects of royal jelly on inflammation and cellular senescence in patients with chronic kidney disease (CKD) on hemodialysis (HD). **Detailed Description:** Royal jelly is a substance produced in the hypopharyngeal glands of bees that operate young, and rich in bioactive compounds such as polyphenols, free fatty acids and exclusive peptides capable of mitigating inflammation and premature aging (genomic instability, mitochondrial dysfunction, shortening of telomeres) existing in patients with chronic kidney disease (CKD) on hemodialysis. However, to date there are no studies evaluating the effects of royal jelly on such complications in patients with RDC. Objectives: To evaluate the effects of royal jelly on inflammation and cellular senescence in patients with CKD. Methods: Clinical, longitudinal, randomized study, with washout and crossover period. Patients with CKD on HD received 140 mL bottles containing propolis and turmeric, and were instructed to take 10 mL/day (dosing cup), containing a dose equivalent to 110 mg/day of standardized green propolis extract (EPP-AF) plus 130 mg of curcuminoids/day or placebo for 8 weeks. After this supplementation, patients will enter the washout period (8 weeks) and after this period, the intervention group will receive placebo and vice versa. The collection of biological material (blood and feces) will be done before and after each study period. The mRNA expression of the transcription factors Nrf2 and NF-κB, as well as their target genes, antioxidant enzymes, inflammatory cytokines and the expression of genes and proteins that modulate the protein will be evaluated using rtPCR, western blotting and assay methods. multiplex. Uremic toxins from the intestinal microbiota such as indoxyl sulfate (IS), p-cresyl sulfate (p-CS) and Indole-3-acetic acid (IAA) will be confirmed by HPLC and plasma lipopolysaccharide (LPS) levels will be analyzed by ELISA. The determination of antioxidant capacity will be determined by the FRAP, ORAC AND DPPH methods. The analysis of the composition of the intestinal microbiota will be evaluated by high-throughput sequencing of the V4-V5 region of the 16S ribosomal RNA gene. Nutritional status and dietary intake will also be assessed. ### Conditions Module **Conditions:** - Kidney Failure, Chronic - Oxidative Stress - Hemodialysis **Keywords:** - Cellular Senescence - Renal Dialysis - Renal Insufficiency, Chronic - Oxidative Stress ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with chronic kidney disease on hemodialysis will receive capsules containing 500mg of royal jelly/day for two months. **Intervention Names:** - Dietary Supplement: Real Jelly **Label:** Real Jelly Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients with chronic kidney disease on hemodialysis will receive capsules containing 500mg of placebo/ day for two months. **Intervention Names:** - Dietary Supplement: Placebo **Label:** Placebo group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Real Jelly Group **Description:** Participants will receive 500mg of royal jelly capsules per day for two months. **Name:** Real Jelly **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Placebo group **Description:** Participants will receive 500mg of placebo capsules per day for two months. **Name:** Placebo **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** The mRNA levels of Nrf2, Keap1, Bach1, NLPR3, NF-kB, HO-1, NQO1, p14, p16, p21 and p53 as well as VCAM, ICAM and E-selectin and TLR-4, TNFR and AhR receptors will be evaluated from peripheral blood mononuclear cells. **Measure:** Change in inflammatory biomarkers **Time Frame:** 6 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients with CKD undergoing hemodialysis for more than 6 months * patients with arteriovenous fistula (AVF) as vascular access. Exclusion Criteria: * pregnant, * lactating, * smoker * patients using antibiotics and antioxidant supplements in the last three months * patients with autoimmune and infectious diseases, * patients with cancer, liver disease, and AIDS **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** dmafra30@gmail.com **Name:** Denise Mafra **Phone:** 21985683003 **Role:** CONTACT #### Locations **Location 1:** **City:** Rio de Janeiro **Country:** Brazil **Facility:** Denise Mafra **State:** RJ **Zip:** 22260050 ## 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: 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: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown - ID: M10699 - Name: Kidney Failure, Chronic - Relevance: HIGH - As Found: Kidney Failure, Chronic - ID: M26718 - Name: Renal Insufficiency - Relevance: HIGH - As Found: Kidney Failure - 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: HIGH - As Found: Chronic ### Condition Browse Module - Meshes - ID: D000007674 - Term: Kidney Diseases - ID: D000051436 - Term: Renal Insufficiency, Chronic - ID: D000051437 - Term: Renal Insufficiency - ID: D000007676 - Term: Kidney Failure, Chronic ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M14295 - Name: Propolis - Relevance: LOW - As Found: Unknown - ID: T364 - Name: Bee Products - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438432 **Acronym:** Activ'Tronc **Brief Title:** Trunk Activity Rehabilitation in Young Children With Cerebral Palsy **Official Title:** Trunk Activity Rehabilitation in Young Children With Cerebral Palsy #### Organization Study ID Info **ID:** RR-Flavigny-2023-2 #### Organization **Class:** OTHER **Full Name:** Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est ### Status Module #### Completion Date **Date:** 2024-10-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-10-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-25 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Children with CP exhibit trunk control issues from early childhood, affecting their balance and gait. These issues manifest as unstable walking, increased step width, and more pronounced anterior deceleration of the sternum. Previous studies have shown that early action of the triceps surae compensates for the deficit in trunk postural control. Rehabilitation targeting the trunk has shown significant improvements in postural control and gait. The main objective is to demonstrate that RAIT significantly reduces the peak anterior deceleration of the sternum at the beginning of the stance phase during barefoot spontaneous walking, with an enhanced effect from prolonged RAIT duration. Secondary objectives include reducing the downward deceleration of the fifth lumbar vertebra (L5), step width, gait variability index, and improving scores on the early clinical balance scale and the global motor function evaluation. Participants, children with spastic paraparesis or spastic hemiparesis capable of walking independently, are divided into two groups: one group continuing their usual rehabilitation for 3 months followed by RAIT for 9 months (RH-RAIT), and one group following RAIT for 12 months (RAIT-RAIT). RH involves rehabilitation exercises for lower limb muscles, while RAIT focuses on improving trunk postural control through activities involving intermediate postures. Functional motor assessments will be conducted initially, then at 3, 6, and 12 months. These include clinical evaluations, gait analysis (step width, gait variability index, anterior foot support), and an analysis of static standing displacement using an inertial sensor placed at L5. At M0, children with CP are expected to show higher values for deceleration peaks and gait variability indices, and lower scores on evaluation scales compared to typically developing (TD) children. After RAIT, an improvement in judgment criteria is expected: reduction in deceleration peaks, cycle width, gait variability index, anterior foot support, and an increase in scores on the ECPE and EMFG-66-SI. This study aims to confirm that rehabilitation through trunk-involving activities is more effective than usual rehabilitation in improving postural control and gait dynamics in young children with cerebral palsy, suggesting that this approach could become a standard rehabilitation practice from early childhood. ### Conditions Module **Conditions:** - Children With Cerebral Palsy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 32 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A first group of children will continue their usual rehabilitation (RH) for the first 3 months and then have RAIT for the following 9 months. **Intervention Names:** - Other: RAIT **Label:** RH-RAIT **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The second group of children will have RAIT from the outset during the 12 months of the study. **Intervention Names:** - Other: RAIT **Label:** RAIT-RAIT **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - RAIT-RAIT - RH-RAIT **Description:** The RAIT program focuses on improving postural control and balance of the entire body, including the trunk and other affected muscles, through autonomous actions in intermediate postures. This approach uses fundamental automatic control of postural support and balance to enhance the use of affected muscles during all postural and locomotor tasks. The child controls their balance during various voluntary actions from intermediate postures like alternating between four-legged and cobra postures, or swinging from the camel posture. These actions, less difficult than standing and walking, are expected to benefit the latter. The child also performs more challenging trunk movements, requiring dissociation of scapular and pelvic girdle movements or reducing lumbar lordosis. **Name:** RAIT **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Varaible obtained via the analysis of walking on a zeno treadmill. A reduced value is expected after RAIT rehabilitation. **Measure:** Peak anterior deceleration of the sternum at the start of weight-bearing **Time Frame:** At inclusion, then 3, 6 and 12 months later #### Secondary Outcomes **Description:** The Evaluation Motrice Fonctionnelle Globale 66 (EMFG-66) is a standardized 66-item clinical score used to assess global motor function and its evolution over time in children with cerebral palsy. The EMFG-66-SI is a faster (approx. 20 to 30 minutes vs. 60 to 80 minutes), validated scoring method for the EMFG-66, using 15 to 39 items. The higher the score, the better. **Measure:** EMFG-66-SI **Time Frame:** At inclusion, then 3, 6 and 12 months later **Description:** This is a 13-item clinical scale for assessing postural stability (balance ability) in children with cerebral palsy, with two subscales: one dedicated to head and trunk postural control, the other to sitting and standing postural control.The scale has been validated for children aged 1.5 to 11, regardless of GMFCS level (40,47). The scale has been validated for children aged 1.5 to 11, regardless of GMFCS level.)The optimal score is 100. Administering the scale takes around 15 minutes. The higher the score, the better. **Measure:** The Early Clinical Balance Scale **Time Frame:** At inclusion, then 3, 6 and 12 months later **Description:** This questionnaire for parents, based on the child's voluntary movements for sitting, transferring and mobility, provides a 5-level classification of the severity of the child's cerebral palsy. Score between 1 and 5. The higher the score, the more severe the cerebral palsy. **Measure:** Global Motor Function Classification System family report questionnaire **Time Frame:** At inclusion **Description:** This is a questionnaire designed for parents to assess the upper limb and hand abilities in different functional situations of their child with CP. This questionnaire, validated for children with CP from the age of 2, will help to assess the expected improvement in hand and upper limb function linked to RAIT. The higher the score, the better. **Measure:** "Reach out" questionnaire **Time Frame:** At inclusion, then 3, 6 and 12 months later **Description:** This examination consists of measuring the amplitude of movement of the main joints in one or more planes, using a goniometer. Check against standards for each joint **Measure:** Neuro-orthopaedic assessment **Time Frame:** At inclusion, then 3, 6 and 12 months later **Description:** This examination consists of measuring spasticity of the main muscles, by mobilizing a joint at slow and then fast speed to elicit a stretch reflex. Score between 0 and 4. 4 indicates the highest level of spasticity. **Measure:** Neuro-orthopaedic assessment **Time Frame:** At inclusion, then 3, 6 and 12 months later **Description:** This examination consists of measuring the muscular strength of the main muscle groups, by asking the subject to mobilize a joint against resistance. Score between 0 and 5. The higher the score, the better. **Measure:** Neuro-orthopaedic assessment **Time Frame:** At inclusion, then 3, 6 and 12 months later **Description:** varaible obtained via the analysis of walking on a zeno treadmill. A reduced value is expected after RAIT rehabilitation. **Measure:** peak downward deceleration of L5 at the start of support **Time Frame:** At inclusion, then 3, 6 and 12 months later **Description:** Composite score based on 9 spatio-temporal parameters that quantifies the distance between the amount of variability observed in an asymptomatic reference group and the amount of variability observed in the patient. This index assesses gait instability and the risk of falling. It is usually high in children with CP. **Measure:** Gait variability index **Time Frame:** At inclusion, then 3, 6 and 12 months later **Description:** Varaible obtained via the analysis of walking on a zeno treadmill. A reduced value is expected after RAIT rehabilitation. **Measure:** Cycle width **Time Frame:** At inclusion, then 3, 6 and 12 months later **Description:** Ratio between the integrated pressure of the forefoot and the integrated pressure of the whole foot during the 1st double support. This variable will be higher the more the foot is supported on the ground by the forefoot, as in the PC child, and lower the more the foot is supported by the heel, as in the typically developing child. **Measure:** Anterior support of the foot during 1st double support **Time Frame:** At inclusion, then 3, 6 and 12 months later **Description:** Score developed for children with cerebral palsy, assessing the extent of kinematic deviations compared to typically developing children. (0 = normal, 1 = moderate or mild pathology, 2 = severe pathology). So 0 here means the best EVGS score. **Measure:** Edinburgh walk visual score **Time Frame:** At inclusion, then 3, 6 and 12 months later ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: For children with CP * Age between 18 months and 5 years 6 months * CP type: spastic paraparesis or spastic hemiparesis, GMFCS I to II * No or moderate retraction of the sural triceps (ankle dorsiflexion: \> 5° on clinical examination, knee straight) * Sufficient level of understanding to carry out activities involving the trunk in the form of self-exercises (rehabilitation protocol), as well as clinical assessments and functional explorations. * Acceptance by the physiotherapist in charge of the child's follow-up to collaborate in carrying out the RAIT. * Affiliated with a social security scheme For children with DT * Age between 18 months and 5 years 6 months * Walking acquired before age 18 months * Sufficient level of understanding to perform clinical assessments and functional explorations * Affiliated with a social security scheme Exclusion Criteria: For children with CP * Previous surgery on lower limbs less than 1 year ago * Botulinum toxin A injection less than 6 months ago * Any change in rehabilitative and/or orthopedic management in the last 2 months * Hip flessum \> 20 * Presence of subacute or chronic pain on standing or walking For children with DT - Neurological and/or orthopedic disorders that may influence gait **Healthy Volunteers:** True **Maximum Age:** 6 Years **Minimum Age:** 18 Months **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jonathan.pierret@ugecam.assurance-maladie.fr **Name:** Jonathan Pierret, PhD **Phone:** +33 3 83 52 6761 **Role:** CONTACT **Contact 2:** **Name:** Christian Beyaert, PU-PH **Role:** CONTACT #### Locations **Location 1:** **City:** Nancy **Contacts:** ***Contact 1:*** - **Email:** jonathan.pierret@ugecam.assurance-maladie.fr - **Name:** Jonathan Pierret, PhD - **Phone:** +33 3 82 52 6761 - **Role:** CONTACT ***Contact 2:*** - **Name:** Christian Beyaert, PU-PH - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** Institut Régional de Médecine Physique et de Réadaptation **Status:** RECRUITING **Zip:** 54000 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009422 - Term: Nervous System Diseases - ID: D000001925 - Term: Brain Damage, Chronic - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5796 - Name: Cerebral Palsy - Relevance: HIGH - As Found: Cerebral Palsy - ID: M13157 - Name: Paralysis - Relevance: LOW - As Found: Unknown - ID: M5207 - Name: Brain Injuries - Relevance: LOW - As Found: Unknown - ID: M5202 - Name: Brain Damage, Chronic - 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: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002547 - Term: Cerebral Palsy ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438419 **Acronym:** MOVOSCILLCBGT **Brief Title:** Parkinsonism-Related Oscillations in the Cortico-Basal Ganglia-Thalamic Network During Movement: Beyond the Frequency Range **Official Title:** Parkinsonism-Related Oscillations in the Cortico-Basal Ganglia-Thalamic Network During Movement: Beyond the Frequency Range #### Organization Study ID Info **ID:** CHUBX 2023/63 #### Organization **Class:** OTHER **Full Name:** University Hospital, Bordeaux ### Status Module #### Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Université de Bordeaux, IMN, UMR CNRS 5293 #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Bordeaux #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Expression of hypokinetic and hyperkinetic motor symptoms in Parkinson's disease (PD) is associated with pathological synchronous oscillations of neuronal activity (local field potential/LFP) in the cortico-subcortical network with a wide frequency range. In the present project, we propose to study cortico-subcortical oscillations and their synchronization in patients operated for PD (subthalamic deep brain stimulation (STN-DBS)) during distinct pharmacological and stimulation conditions (hypokinetic and hyperkinetic), using a simple motor task. **Detailed Description:** To define the link between the characteristics of neuronal oscillations (frequency, amplitude, phase relationship) within the cortico-subcortical network and the movement, we designed a simple motor task of gripping/pulling a lever. The LFPs will be collected at the cortical and subcortical levels (STN) during the motor task using a high-resolution EEG (HR-EEG) and the Percept™ system (Medtronic). Recordings will be realized in four conditions: without pharmacological treatment and without stimulation (Off condition), without pharmacological treatment and during stimulation (DBS condition), during pharmacological treatment and without stimulation (DOPA condition) and during pharmacological treatment and stimulation (DOPA+DBS condition). ### Conditions Module **Conditions:** - Parkinson Disease - Hyperkinesis - Hypokinesia **Keywords:** - Parkinson disease - hypokinetic disorders - dyskinesia - networks - basal ganglia ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patient with idiopathic Parkinson's disease and having a STN DBS with a PERCEPT™ for less than a year or being candidate for subthalamic nucleus deep brain stimulation with the PERCEPT™ device (first-implantation) **Intervention Names:** - Other: Electrophysiological recordings **Label:** Recruited patient **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Recruited patient **Description:** Electrophysiological recordings will be made during a motor task in four different conditions: 1. without pharmacological treatment and without stimulation (Off condition), 2. without pharmacological treatment and during stimulation (DBS condition), 3. during pharmacological treatment and without stimulation (DOPA condition), 4. during pharmacological treatment and stimulation (DOPA+DBS condition). **Name:** Electrophysiological recordings **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Statistically significant difference in the cortico-subcortical electrophysiological coherence value between a movement performed in hypokinetic condition and a movement performed in hyperkinetic condition **Measure:** Cortico-subcortical electrophysiological coherence **Time Frame:** At inclusion (D0) #### Secondary Outcomes **Description:** Demonstration of a significant difference in spectral signal power between movement in hypokinetic and hyperkinetic conditions. **Measure:** Spectral signal power **Time Frame:** At inclusion (D0) **Description:** Demonstration of a significant effect of STN-DBS on spectral signal power and cortico-subcortical synchronization during movement in hypokinetic or hyperkinetic conditions **Measure:** Effect of STN-DBS on spectral signal power **Time Frame:** At inclusion (D0) **Description:** Demonstration of a statistical correlation between semiological characteristics (hypo- and hyperkinesia, movement parameters (reaction time and movement time)) and electrophysiological characteristics. **Measure:** Correlation between semiological characteristics **Time Frame:** At inclusion (D0) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or Female * 18 to 75 years-old * With idiopathic Parkinson's disease * Having a STN-DBS with a PERCEPT™ for less than a year or being candidate for STN-DBS with the PERCEPT™ device (first-implantation) * Able to perform the simple motor task * Patients covered by a health insurance scheme * Giving free, informed, written consent signed by the participant and the investigator. Exclusion Criteria: * Be incapable of giving consent personally. * Be subject to a legal protection measure (curatorship, guardianship) or be placed under judicial protection. * Being pregnant or breastfeeding * Present a serious and/or decompensated somatic or psychiatric illness. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** dominique.guehl@chu-bordeaux.fr **Name:** GUEHL Dominique, Pr **Phone:** 5 57 82 12 42 **Phone Ext:** +33 **Role:** CONTACT **Contact 2:** **Email:** claire.brandet@chu-bordeaux.fr **Name:** Claire BRANDET **Role:** CONTACT #### Locations **Location 1:** **City:** Bordeaux **Contacts:** ***Contact 1:*** - **Email:** dominique.guehl@chu-bordeaux.fr - **Name:** Dominique Guehl, Pr - **Role:** CONTACT ***Contact 2:*** - **Email:** claire.brandet@chu-bordeaux.fr - **Name:** Claire BRANDET - **Role:** CONTACT **Country:** France **Facility:** Bordeaux University Hospital ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001480 - Term: Basal Ganglia Diseases - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009069 - Term: Movement Disorders - ID: D000080874 - Term: Synucleinopathies - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000003560 - Term: Cysts - ID: D000009369 - Term: Neoplasms - ID: D000017520 - Term: Mucinoses - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000020820 - Term: Dyskinesias - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M13213 - Name: Parkinson Disease - Relevance: HIGH - As Found: Parkinson's Disease - ID: M25603 - Name: Ganglion Cysts - Relevance: HIGH - As Found: Ganglion - ID: M22494 - Name: Parkinsonian Disorders - Relevance: HIGH - As Found: Parkinsonism - ID: M20582 - Name: Hypokinesia - Relevance: HIGH - As Found: Hypokinesia - ID: M9999 - Name: Hyperkinesis - Relevance: HIGH - As Found: Hyperkinesis - ID: M22574 - Name: Dyskinesias - Relevance: LOW - As Found: Unknown - ID: M16358 - Name: Synovial Cyst - Relevance: LOW - As Found: Unknown - ID: M6765 - Name: Cysts - Relevance: LOW - As Found: Unknown - ID: M4774 - Name: Basal Ganglia Diseases - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12029 - Name: Movement Disorders - Relevance: LOW - As Found: Unknown - ID: M2217 - Name: Synucleinopathies - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M19781 - Name: Mucinoses - Relevance: LOW - As Found: Unknown - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000045888 - Term: Ganglion Cysts - ID: D000010300 - Term: Parkinson Disease - ID: D000020734 - Term: Parkinsonian Disorders - ID: D000018476 - Term: Hypokinesia - ID: D000006948 - Term: Hyperkinesis ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M7471 - Name: Dihydroxyphenylalanine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438406 **Brief Title:** Postural Assessment, Therapeutic Exercise and Orthotic Devices in the Prevention of Haemophilic Arthropathy **Official Title:** Postural Assessment, Therapeutic Exercise and Orthotic Devices in the Prevention of Haemophilic Arthropathy #### Organization Study ID Info **ID:** MFR052024 #### Organization **Class:** OTHER **Full Name:** University of Palermo ### Status Module #### Completion Date **Date:** 2024-05-27 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-10-30 **Type:** ACTUAL #### Start Date **Date:** 2023-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Palermo #### Responsible Party **Investigator Affiliation:** University of Palermo **Investigator Full Name:** Prof.ssa Giulia Letizia Mauro **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Haemophilic arthropathy (HA) is the most frequent complication of haemophilia and is often associated with a severe deterioration in quality of life. It is caused by repeated joint bleeding resulting in chronic proliferative synovitis and progressive destruction of articular cartilage. The most frequently affected joints are the knees, ankles and elbows. The aim of this study is to verify the use of lower limb orthoses in combination with postural rehabilitation, assessing the incidence of spontaneous haemarthroses and haematomas as the primary endpoint and pain and QoL as secondary endpoints. We conducted a prospective observational, randomised and controlled study on outpatients attending the UOC of Recovery and Functional Rehabilitation of the AOUP Paolo Giaccone of Palermo for haemophilic arthropathy sent by the UO of Haematology of the same hospital. The study period was between January 2017 and March 2023. The patients recruited were randomly divided into two groups by means of a computer-generated random number system: group A, consisting of patients who were prescribed orthoses and a 20-session rehabilitation programme; group B, consisting of patients who were only prescribed orthoses for the lower limbs. The rehabilitation programme was based on the Back School method. All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2). Two arthropathic-specific scales were used to assess outcomes, namely the Hemophilia Joint Health Score (HJHS), which reflects joint function and status, and the Functional Independence Score in Hemophilia (FISH), which relates to the patient\&#39;s quality of life. We also used the Numerical Rating Scale (NRS) for joint pain. Finally, postural assessment was performed in static posture, observing the patient\&#39;s alignment in different planes and using the APECS (AI Posture Evaluation and Correction System ®) mobile app. During the re-evaluations, any new haemarthroses and haematomas were also assessed. ### Conditions Module **Conditions:** - Haemophilic Arthropathy - Orthosis - Foot Malalignment **Keywords:** - haemophilic arthropathy - orthosis - postural assestment - foot malalignment - therapeutic exercise - haemarthroses - haematomas - HJHS - FISH ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 15 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Group A consisting of patients who were prescribed orthoses, to use gradually, and a 20-session rehabilitation programme, based on the Back School method **Intervention Names:** - Device: Orthotic devices and therapeutic exercise (Group A) - Device: Orthotic devices (Group B) **Label:** Orthotic devices and therapeutic exercise (Group A) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Group B consisting of patients who were only prescribed orthoses for the lower limbs **Intervention Names:** - Device: Orthotic devices and therapeutic exercise (Group A) - Device: Orthotic devices (Group B) **Label:** Orthotic devices (Group B) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Orthotic devices (Group B) - Orthotic devices and therapeutic exercise (Group A) **Description:** Group A consisting of patients who were prescribed orthoses, to use gradually, and a 20-session rehabilitation programme, based on the Back School method **Name:** Orthotic devices and therapeutic exercise (Group A) **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Orthotic devices (Group B) - Orthotic devices and therapeutic exercise (Group A) **Description:** Group B consisting of patients who were only prescribed orthoses for the lower limbs **Name:** Orthotic devices (Group B) **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** During re-evaluations, the possible appearance of new haemarthroses and haematomas was assessed ,which were absent at the baseline examination **Measure:** prevention of haemophilic arthropathy **Time Frame:** All patients were assessed at 3 months (T1) and after 6 months (T2). #### Secondary Outcomes **Description:** This score is a performance-based assessment tool used to measure the functional ability of patients. The maximum score is 32 (the greatest autonomy). **Measure:** Functional Independence Score in Hemophilia (FISH) **Time Frame:** All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2) **Description:** The Hemophilia Joint Health Score is a rating scale that measures joint health in the domains of anatomical structure and function (biomechanics) of the joints most frequently affected by haemorrhage in haemophilia: knees, ankles, elbows. **Measure:** Hemophilia Joint Health Score (HJHS) **Time Frame:** All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2) **Description:** The NRS scale is a one-dimensional 11-point scale that assesses pain intensity in adults, with a range from 0 to 10, corresponding to 'no pain' and 'worst pain imaginable' **Measure:** Numerical Rating Scale (NRS) **Time Frame:** All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * diagnosis of severe haemophilia A or B; * age ≥ 6 years and ≤ 50 years; * presence of hindfoot and/or arch misalignment; * prophylaxis with factor deficient (VIII or IX). Exclusion Criteria: * patients with prosthetic implants/synthetic means * uncooperative patients **Gender Based:** True **Maximum Age:** 50 Years **Minimum Age:** 6 Years **Sex:** MALE **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Palermo **Country:** Italy **Facility:** A.O.U.P. Paolo Giaccone **Zip:** 90127 ### IPD Sharing Statement Module **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR - ANALYTIC_CODE **IPD Sharing:** YES **URL:** https://www.unipa.it/persone/docenti/l/giulia.letiziamauro/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009140 - Term: Musculoskeletal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10621 - Name: Joint Diseases - Relevance: HIGH - As Found: Arthropathy - ID: M9493 - Name: Hematoma - Relevance: LOW - As Found: Unknown - ID: M9483 - Name: Hemarthrosis - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: T2713 - Name: Hemophilic Arthropathy - Relevance: HIGH - As Found: Hemophilic Arthropathy ### 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:** NCT06438393 **Acronym:** SAFE-CT **Brief Title:** Screening Coronary Artery Disease Using artiFicial intelligencE in Non-contrast Computed Tomography **Official Title:** Screening Coronary Artery Disease Using artiFicial intelligencE in Non-contrast Computed Tomography #### Organization Study ID Info **ID:** SAFE-CT #### Organization **Class:** OTHER **Full Name:** Universidade do Porto ### Status Module #### Completion Date **Date:** 2027-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Oxford **Class:** OTHER **Name:** University of Edinburgh #### Lead Sponsor **Class:** OTHER **Name:** Universidade do Porto #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This project aims to improve direct patient care by reducing the risks of futile exposure to ionizing radiation and iodinated contrast in patients referred for coronary computed tomography angiography **Detailed Description:** Since the last NICE guidelines update recommending computed tomography coronary angiography (CTCA) as the first line of investigation for patients with suspected coronary artery disease (CAD), there has been a high burden in the healthcare system and unnecessary exposition to radiation and iodine-containing contrast medium, especially in the youngest. Around 35% of patients who currently undergo CTCA have normal coronaries which means those patients were unnecessary exposed to radiation and contrast. A CTCA screening strategy to rule out CAD is needed to comply with the ALARA ("As Low As Reasonable Achievable") principles preventing radiation risks, reducing unnecessary scans and directing healthcare resources to those who will benefit from a CTCA. We designed the SAFE-CT (Screening coronary Artery disease using artiFicial intelligencE in noncontrast Computed Tomography) study to develop a state-of-art artificial intelligence method to detect CAD as defined on CTCA using high-dimensional data (radiomics) extracted from the non-contrast cardiac computed tomography (CT). The model will be trained in 15,000 subjects scanned with paired non-contrast CT and CTCA and externally validated in an independent cohort of 1,000 subjects. In a preliminary analysis, non-contrast CT radiomics improved calcium score performance and discriminated CAD with an AUC of 0.91 (95% CI: 0.83-1.00). The algorithm will be converted into a user-friendly plugin to automatically decide whether the patient needs contrast. A real-world multicentre cohort study will be planned for software prospective validation and the creation of a large-scale proteomic biobank to support the translation of imaging biomarkers worldwide. SAFE-CT can change the current CT scanning workflow by creating software that accurately rules out any CAD in \>1/3 of patients referred for CTCA with low radiation and no contrast. This accurate machine learning model will be optimized to reach \>90% sensitivity and negative predictive value and will bring several advantages for patients and the healthcare system: * Prevention of radiation and contrast exposition. * Increased CTCA scanning capacity for complex cases. * Widespread use of CT for CAD exclusion in the emergency department and in outpatient clinics of centres with no CTCA. * Improved screening tool for CAD in asymptomatic subjects. * Up- and downstream cost reduction. The SAFE-CT project proposes a safer, low-cost, and personalized CTCA scanning strategy that fosters scientific and technological innovation with the potential to bring improvement to patient care and clinical practice, and, thereby, societal, and economic impact. ### Conditions Module **Conditions:** - Coronary Artery Disease - Coronary Atheroscleroses **Keywords:** - Artificial intelligence - Radiomics - Deep learning - Coronary artery disease - Non-contrast computed tomography ### Design Module #### Bio Spec **Description:** Peripheral blood samples for proteomics analysis **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** OTHER **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 1000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** CAD: Presence of minimal coronary artery disease (i.e., coronary stenosis 0-25%) Normal coronary arteries: No visible coronary atherosclerosis **Intervention Names:** - Diagnostic Test: CT coronary angiography and non-contrast CT **Label:** Stable chest pain and unknown CAD who underwent CTCA and CCS in the same scanning session ### Interventions #### Intervention 1 **Arm Group Labels:** - Stable chest pain and unknown CAD who underwent CTCA and CCS in the same scanning session **Description:** A CTCA is an X-ray computed tomography of the coronary arteries that allows visualization of coronary plaques with high temporal and spatial resolution, however, it implies the use of iodine contrast and exposition to clinically significant ionizing radiation. Non-contrast ECG-gated CT ("calcium score" - CCS image). A non-contrast cardiac CT for CCS can be performed very quickly with significantly lower radiation (\~6 times lower) than CTCA and without the need for contrast. **Name:** CT coronary angiography and non-contrast CT **Other Names:** - Non-contrast computed tomography **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Measure:** Build a non-contrast CT radiomic signature of CAD **Time Frame:** 3 years **Measure:** Implement a machine learning model to discriminate patients with no CAD from patients with at least minimal disease (CAD-RADS=0 vs. CAD-RADS>0). **Time Frame:** 3 years **Measure:** Implement a machine learning model to detect coronary inflammation as defined using the Fat Attenuation Index (FAI ≥ -70.1 HU) in patients with no visible coronary plaque (CAD-RADS=0). **Time Frame:** 3 years **Measure:** Build a user-friendly plugin to facilitate users experience and distribution of our technology in clinical practice. **Time Frame:** 3 years **Measure:** Evaluate the real-world operationality and performance of the plugin in an international multicentre prospective cohort study. **Time Frame:** 3 years **Measure:** Create a national registry of cardiac CT **Time Frame:** 3 years #### Secondary Outcomes **Measure:** Setup a human blood biobank to identify the peripheral blood mononuclear cells (PBMCs) and plasma proteomics associated with CT data and clinical outcomes. **Time Frame:** 3 years **Measure:** Setup a public CT imaging repository **Time Frame:** 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: - Patient with stable chest pain who underwent a CTCA Exclusion Criteria: * Missing non-contrast CT image (coronary calcium score image) * Known coronary artery disease * Prior myocardial infarction * Prior PCI or CABG **Healthy Volunteers:** True **Maximum Age:** 100 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Stable chest pain patients with unknown CAD who underwent a CTCA with paired non-contrast CT ### Contacts Locations Module #### Locations **Location 1:** **City:** Porto **Country:** Portugal **Facility:** Faculty of Medicine of Porto ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000001161 - Term: Arteriosclerosis - ID: D000001157 - Term: Arterial Occlusive Diseases - ID: D000014652 - Term: Vascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M6546 - Name: Coronary Artery Disease - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M26188 - Name: Atherosclerosis - Relevance: HIGH - As Found: Atherosclerosis - ID: M19506 - Name: Myocardial Ischemia - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M6549 - Name: Coronary Disease - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M4469 - Name: Arteriosclerosis - Relevance: LOW - As Found: Unknown - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003324 - Term: Coronary Artery Disease - ID: D000017202 - Term: Myocardial Ischemia - ID: D000003327 - Term: Coronary Disease - ID: D000050197 - Term: Atherosclerosis ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: BDCA - Name: Bone Density Conservation Agents ### Intervention Browse Module - Browse Leaves - ID: M10488 - Name: Iodine - Relevance: LOW - As Found: Unknown - ID: M229695 - Name: Cadexomer iodine - Relevance: LOW - As Found: Unknown - ID: M5381 - Name: Calcium - Relevance: LOW - As Found: Unknown - ID: M5398 - Name: Calcium, Dietary - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438380 **Brief Title:** User Experience of a Telemedicine Platform for the Follow-up of Post Intensive Care Syndrome (PICS) **Official Title:** Experience of Critically Ill Patients in the Use of a Telemedicine Platform for the Follow-up of Post Intensive Care Syndrome (PICS) After ICU Discharge #### Organization Study ID Info **ID:** 2023/5126 #### Organization **Class:** NETWORK **Full Name:** Parc Tauli Research and Innovation Institute Foundation ### Status Module #### Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** NETWORK **Name:** Parc Tauli Research and Innovation Institute Foundation #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Survivors of critical illness may present with a set of physical, emotional and cognitive sequelae, known as Post Intensive Care Syndrome (PICS). These alterations can become chronic over time and significantly affect patients' quality of life. Therefore, follow-up and monitoring of critically ill patients after ICU discharge, for example through telemedicine, could be essential for the prevention, early detection and management of PICS. Our main objective is to evaluate the suitability and user experience of a telemedicine platform from the perspective of critically ill patients. This study proposes the participation of ICU survivors in the design and improvement of a telemedicine platform for PICS follow-up through a qualitative approach. Participants will test the platform in person three months after discharge from the ICU and then undergo a semi-structured interview to assess their experience. The findings derived from this study may contribute to improve both the content and the format of the platform, optimizing resources and facilitating the management of post-ICU sequelae, which will have a positive impact on the patient's recovery process. ### Conditions Module **Conditions:** - Critical Illness **Keywords:** - Qualitative research - Post-Intensive Care Syndrome ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 14 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** To evaluate the user experience of a telemedicine platform for monitoring post-intensive care syndrome from the perspective of critically ill patients after ICU discharge through semi-structured interviews **Measure:** 1:1 semi-structured interviews **Time Frame:** 3 months after ICU discharge ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult patients (≥18 years) * Admitted to a medical/surgical ICU * For respiratory failure, cardiogenic shock, or septic shock * With an expected ICU stay of ≥48 hours * Catalan and/or Spanish speakers * Who are able to give informed consent by themselves Exclusion Criteria: * History of intellectual disability or other neurodevelopmental disorders, such as autism spectrum disorder * History of neurological disorders, dementia or other neurodegenerative diseases, such as epilepsy, Alzheimer's disease, Parkinson's disease or multiple sclerosis * History of brain damage, such as traumatic brain injury or stroke * History of severe psychiatric illness, such as psychotic, bipolar, depressive, obsessive-compulsive, post-traumatic or personality disorder * Suspected or confirmed substance use disorder * Suspected or confirmed communicable disease in an isolated patient * Uncorrected hearing or visual impairment * Enrolled in another trial that does not allow co-enrollment **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Critically ill patients admitted to the ICU of the Parc Tauli Hospital (Sabadell, Spain). ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** mrgodoy@tauli.cat **Name:** Marta Godoy-González, PhD student **Phone:** +34937236673 **Role:** CONTACT **Contact 2:** **Email:** msfernandez@tauli.cat **Name:** Sol Fernández-Gonzalo, PhD **Phone:** +34937236673 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000020969 - Term: Disease Attributes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M19010 - Name: Critical Illness - Relevance: HIGH - As Found: Critical Illness - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016638 - Term: Critical Illness ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438367 **Brief Title:** TGRX-326 Pharmacokinetic Mass Balance **Official Title:** Mass Balance Study of [14C]TGRX-326 in Healthy Adult Chinese Male Participants #### Organization Study ID Info **ID:** TGRX-326-1004 #### Organization **Class:** INDUSTRY **Full Name:** Shenzhen TargetRx, Inc. ### Status Module #### Completion Date **Date:** 2024-10-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-08-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** The First Affiliated Hospital of Soochow University #### Lead Sponsor **Class:** INDUSTRY **Name:** Shenzhen TargetRx, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is a pharmacokinetic study for TGRX-326 on mass balance to evaluate distribution, metabolism and excretion of TGRX-326, an ALK inhibitor indicated for treatment of Non-small cell lung cancer. **Detailed Description:** This study is designed as a single-center, single-dose, non-randomized and open-label study. The study will be conducted in healthy male participants to evaluate distribution, metabolic pathways and route of excretion of TGRX-326 using the Carbon-14 labelled isotope of TGRX-326 compound. Safety evaluation will also be conducted. ### 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:** 6 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** healthy subjects will be given 60mg/100uCi\[14C\]TGRX-326 in suspension **Intervention Names:** - Drug: [14C]TGRX-326 **Label:** Experimental: TGRX-326 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental: TGRX-326 **Description:** Healthy subjects will be given TGRX-326 60 mg orally on day 1. **Name:** [14C]TGRX-326 **Other Names:** - TGRX-326 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** \[C14\]TGRX-326 radioactivity detected in urine **Measure:** Urine radioactivity **Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing **Description:** \[C14\]TGRX-326 radioactivity detected in feces **Measure:** Fecal radioactivity **Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing **Description:** percentage of \[C14\]TGRX-326 radioactivity in plasma **Measure:** Plasma AUC (Area under curve) percentage **Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing **Description:** percentage of \[C14\]TGRX-326 radioactivity in urine **Measure:** Urine %Dose **Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing **Description:** percentage of \[C14\]TGRX-326 radioactivity in feces **Measure:** Fecal %Dose **Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing **Description:** Maximum concentration of \[C14\]TGRX-326 measured in plasma **Measure:** Plasma Cmax **Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing **Description:** Time to maximum concentration of \[C14\]TGRX-326 measured in plasma **Measure:** Plasma Tmax **Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing #### Secondary Outcomes **Description:** to record and analyse subjects with adverse events (AEs) and serious adverse events (SAEs) **Measure:** Adverse events/serious adverse events **Time Frame:** From screening through completion of study, an average of 1 to 1.5 months. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy adult males * Age between 18 and 45 years old (both limits included) * Body weight index between 19.0 and 26.0 kg/m2 (both limits included), and body weight not less than 50.0kg * Willing to consent * Able to communicate with investigator and complete study according to study protocol Exclusion Criteria: * Clinically significant results from comprehensive physical and clinical examinations * Positive results on hepatitis, HIV or syphilis * Clinically significant results from eye examination * Usage of inducer or inhibitor drugs to drug metabolism with 30 days prior to screening * Usage of any prescription or non-prescription drug, Chinese herbal medicine or dietary supplements * Presence of any significant medical history or clinical conditions that could affect study results per investigators' judgement * Presence of any condition that could affect drug absorption * Reception of major surgery within 6 months before screening, or surgical wounds not completely healed * Presence of allergic reactions or may be allergic to ingredients in the investigational drug * Presence of hemorrhoids, or having history of or is having conditions that cause bloody feces * Habitual congestion or diarrhea * Alcohol abuse or excessive alcohol consumption within 6 months before screening * Excessive smoking within 3 months before screening * Substance abuse or positive results on urine substance test * Habits of grapefruit juice consumption or excessive caffeinated drinks consumption * History of long-term exposure under radiation; or significant radiation exposure 1 year before this study; or participation in other radioactive drug studies * Having difficulties to receive venous needle puncture, or cannot tolerate venous needle puncture, or history of hematophobia or needle sickness * Participation in any other clinical studies within 3 months before screening * Reception of vaccine within 1 months before screening, or planning to be vaccinated during the study * Planning to have children or donate sperms during the study and within 1 year after the study, or Not agreeing to take contraceptive measures during and within 1 year after study completion * Blood donation or blood loss of \> 400 ml within 3 months before screening; blood donation or blood loss of \> 200 ml within 1 month before screening; reception of blood transfusion within 1 months before screening, or planning to donate blood within 3 months after study completion * Having special dietary requirements and unable to follow the uniform dietary plan in the study * Any conditions that the investigator deemed unfit for the study **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** haifang.guo@tjrbiosciences.com **Name:** Haifang Guo, PhD **Phone:** +86-18762407693 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** The First Affiliated Hospital of Soochow University **Name:** Liyan Miao, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002283 - Term: Carcinoma, Bronchogenic - ID: D000001984 - Term: Bronchial Neoplasms - ID: D000008175 - Term: Lung Neoplasms - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: HIGH - As Found: Non-Small Cell Lung Cancer - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M5540 - Name: Carcinoma, Bronchogenic - Relevance: LOW - As Found: Unknown - ID: M5260 - Name: Bronchial Neoplasms - Relevance: LOW - As Found: Unknown - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002289 - Term: Carcinoma, Non-Small-Cell Lung ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438354 **Brief Title:** Non-surgical Step 3 Periodontal Treatment With/Without Adjunctive Protocol - Pilot RCT. **Official Title:** Non-surgical Treatment of Residual Periodontal Pockets Using Sodium Hypochlorite/Amino Acid Gel and Cross-linked Hyaluronic Acid - a 9-month Randomized Controlled Clinical Trial. #### Organization Study ID Info **ID:** 64/2022 #### Organization **Class:** OTHER **Full Name:** University of Witten/Herdecke ### Status Module #### Completion Date **Date:** 2024-02-29 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-10-30 **Type:** ACTUAL #### Start Date **Date:** 2022-08-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Witten/Herdecke #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Study conducted in patients recruited at private praxis setting after completed step 2 periodontal therapy. Residual pockets ≥4mm with positive bleeding or such \>5mm randomly allocated to either conventional subgingival re-instrumentation (controls) or to same mechanical treatment with adjectively applied hypochlorite/aminoacid gel for antiseptic reason followed by subginigival placement of cross linked hyaluronic acid gel for sealing the site after instrumentation. Re-evaluations at 3 and 9 months controlled for clinical parameters such as Periodontal Probing Depth (PPD) (CAL), Clinical Attachment Level, Gingival Recession (GR), Bleeding on Probing (BOP). The hypothesis is, sites treated with adjunctive protocol show greater PPD reduction and greater CAL gain at 9-month evaluation. ### Conditions Module **Conditions:** - Periodontal Pocket ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 52 **Type:** ACTUAL **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Test arm, patients undergo subgingival instrumentation of residual active site together with an adjunctive treatment protocol. **Intervention Names:** - Biological: subgingival instrumentation plus Perisolv / hyaDent BG **Label:** Group A **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Control arm, patients undergo subgingival instrumentation of residual active site only. **Intervention Names:** - Procedure: subgingival instrumentation **Label:** Group B **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group A **Description:** Group A: Perisolv is applied prior to subgingival instrumentation for disinfecting purpose, hyaDent BG seals the site for accelerated blood clot stabilisation and support of cell proliferation. **Name:** subgingival instrumentation plus Perisolv / hyaDent BG **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Group B **Description:** Group B: sites requiring re-treatment are subjected to subgingival scaling **Name:** subgingival instrumentation **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Greater amount of CAL gain in the test group A vs. control group B anticipated **Measure:** Clinical Attachment Level **Time Frame:** 9 month post-op #### Secondary Outcomes **Description:** Greater reduction in PPD for group A vs. Group B anticipated **Measure:** Periodontal Probing Depth **Time Frame:** 9 months post-op **Description:** Similar change in the GR depth anticipated for both groups **Measure:** Gingival Recession **Time Frame:** 9 months post-op **Description:** greater reduction in BOP anticipated for group A vs. group B patients. **Measure:** Bleeding on Probing **Time Frame:** 9 months post-op ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * systemically healthy individuals, smokers and non-smokers, HbA1c \<7.5%, compliant and adhering to systematic periodontal treatment protocol incl. SPT visits, patients willing to complete a 9-month post-op observation period Exclusion Criteria: * rheumatoid arthritis, HbA1c ≥7.5%, treatment of periodontitis within past 12 months, use of systemic antibiotics in past 6 months, pregnant and lactating individuals **Healthy Volunteers:** True **Maximum Age:** 80 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Munich **Country:** Germany **Facility:** Implantat Competence Centrum München **Zip:** 80333 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Ramanauskaite E, Machiulskiene V, Shirakata Y, Dvyliene UM, Nedzelskiene I, Sculean A. Clinical evaluation of sodium hypochlorite/amino acids and cross-linked hyaluronic acid adjunctive to non-surgical periodontal treatment: a randomized controlled clinical trial. Clin Oral Investig. 2023 Nov;27(11):6645-6656. doi: 10.1007/s00784-023-05271-0. Epub 2023 Sep 23. **PMID:** 37740107 **Citation:** Shirakata Y, Nakamura T, Setoguchi F, Imafuji T, Shinohara Y, Matsumura S, Iwata M, Noguchi K, Ramanauskaite E, Sculean A. Histological evaluation of nonsurgical periodontal treatment with and without the use of sodium hypochlorite / amino acids and cross-linked hyaluronic acid gels in dogs. Clin Oral Investig. 2024 Apr 27;28(5):281. doi: 10.1007/s00784-024-05674-7. **PMID:** 38676852 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010518 - Term: Periodontitis - ID: D000010510 - Term: Periodontal Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13423 - Name: Periodontal Pocket - Relevance: HIGH - As Found: Periodontal Pocket - ID: M13427 - Name: Periodontitis - Relevance: LOW - As Found: Unknown - ID: M13419 - Name: Periodontal Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010514 - Term: Periodontal Pocket ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M9878 - Name: Hyaluronic Acid - Relevance: LOW - As Found: Unknown - ID: M15775 - Name: Sodium Hypochlorite - Relevance: LOW - As Found: Unknown - ID: M44557 - Name: Eusol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438341 **Brief Title:** Preliminary Evaluation of the Safety and Tolerability of SPOT-mRNA01 Subcutaneously Administered in Healthy Subjects **Official Title:** A Randomized, Double-blind, Placebo-controlled Exploratory Clinical Study to Evaluate the Safety and Tolerability of SPOT-mRNA01 Injection in Healthy Adult Subjects #### Organization Study ID Info **ID:** FM-T1-SH #### Organization **Class:** INDUSTRY **Full Name:** Spot Biosystems Ltd. ### Status Module #### Completion Date **Date:** 2025-12-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-30 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University #### Lead Sponsor **Class:** INDUSTRY **Name:** Spot Biosystems 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 first-in-human, randomized, double-blind, placebo-controlled clinical study to evaluate the Safety and Tolerability of SPOT-mRNA01 injection in healthy adult volunteers. **Detailed Description:** SPOT-mRNA01 (collagen 1 alpha 1 (COL1A1) mRNA-loaded EVs) can induce collagen protein grafts in dermal tissue, thereby supplementing collagen and reducing wrinkle formation in collagen-depleted skin. Therefore, SPOT-mRNA01 can provide a source of human collagen intradermally for cosmetic anti-aging use. This is a first-in-human randomized, double-blind, placebo-controlled, single-dose, dose ascending, exploratory clinical study to evaluate the Safety and Tolerability of SPOT-mRNA01 administered by subcutaneous injection to healthy adult volunteers. ### Conditions Module **Conditions:** - Skin Aging **Keywords:** - SPOT-mRNA01 - EVs - COL1A1 mRNA ### 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:** 10 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** SPOT-mRNA01 (COL1A1 mRNA-loaded EVs) **Intervention Names:** - Biological: SPOT-mRNA01 **Label:** SPOT-mRNA01 **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Sterile isotonic solution **Intervention Names:** - Other: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - SPOT-mRNA01 **Description:** SPOT-mRNA01 (COL1A1 mRNA-loaded EVs) ,single-dose subcutaneous injection **Name:** SPOT-mRNA01 **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Sterile isotonic solution **Name:** Placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The investigator will collect a description of the events, time of onset and resolution, assessment of severity and causal relationship to SPOT-mRNA01. **Measure:** Assessment of the safety and tolerability of SPOT-mRNA01 by recording adverse events **Time Frame:** 3 months #### Secondary Outcomes **Description:** Local collagen expression in injection area biopsy by ELISA detection **Measure:** Assessment of changes in collagen expression level after subcutaneous injection of SPOT-mRNA01 **Time Frame:** Days 4, 7 and 31 **Description:** Detecting local skin thickness in injection area biopsy by Masson trichrome stain **Measure:** Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01 **Time Frame:** Days 4, 7 and 31 **Description:** Detecting local skin thickness by Skin ultrasound **Measure:** Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01 **Time Frame:** Baseline and days 7, 15, 31, 61 and 91 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Aged 18 to 75 years inclusive at the time of informed consent. Exclusion Criteria: 1. Any transient or chronic skin condition, disorder, or infection within 20 cm of the target areas before treatment that, in the opinion of the investigator, may confound study results. 2. History of laser treatment or chemical peels or any cosmetic anti-aging treatments to the target areas within six months of the study treatment. 3. History of surgical procedures to target areas, including removal of benign or malignant skin cancers that, in the opinion of the investigator, may confound study results. 4. Participant with a history of heavy smoking, alcohol or drug abuse or steroid treatment. 5. Pregnant or breast-feeding females. 6. History of anaphylaxis or allergic reactions to any constituent of the study product and/or local anesthetics, and/or history of severe abnormal drug reaction. 7. Those who have participated in clinical trials of other investigational drugs within 3 months before the study treatment. 8. Those who are not suitable for subcutaneous injection and biopsy. 9. Any condition that the investigator or primary physician believes may not be appropriate for participating the study. - **Healthy Volunteers:** True **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ## Document Section ### Large Document Module #### Large Docs - Date: 2023-08-14 - Filename: Prot_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: False - Label: Study Protocol - Size: 687192 - Type Abbrev: Prot - Upload Date: 2024-05-24T07:36 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M8219 - Name: Exanthema - Relevance: LOW - As Found: Unknown ### 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:** NCT06438328 **Brief Title:** Effectiveness of Scapular Muscle Training in Improving Grip Strength Among Lateral Epicondylitis Patients **Official Title:** Effectiveness of Scapular Muscle Training in Improving Grip Strength Among Lateral Epicondylitis Patients #### Organization Study ID Info **ID:** MSRSW/Batch-Fall22/710 #### Organization **Class:** OTHER **Full Name:** Superior University ### Status Module #### Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-04-01 **Type:** ACTUAL #### Start Date **Date:** 2023-11-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Muhammad Naveed Babur #### Responsible Party **Investigator Affiliation:** Superior University **Investigator Full Name:** Muhammad Naveed Babur **Investigator Title:** Principal Investigator **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The effectiveness of scapular muscular training along with conventional physiotherapy on the improving the grip strength of the patients suffering with the lateral epicondylitis was assessed by diving 56 patinets in two grousp as Group A (n=28) was treated with conventional physiotherapy treatment and Group B (n=28) was treated with Scapular strengthening and conventional physiotherapy protocol. ### Conditions Module **Conditions:** - Lateral Epicondylitis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 56 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Diagnostic Test: Left/ Right affected arm **Label:** Left/ Right affected arm **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Other: Grip strength **Label:** Grip strength **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Left/ Right affected arm **Description:** Therapeutic exercises: eccentric and concentric exercises and wrist isometrics 10 repetitions of 3 sets with 10 seconds interval **Name:** Left/ Right affected arm **Type:** DIAGNOSTIC_TEST #### Intervention 2 **Arm Group Labels:** - Grip strength **Description:** assessed by using modified sphygmomanometer in which it first inflated to 100 mmHg with closed valve. The pressure was reduced to 20mmHg and the resisted wrist extension performed at baseline and at the 4th week. **Name:** Grip strength **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Measured by Patient-Rated Tennis Elbow Evaluation (PRTEE)from the scoring between 0-100 at baseline and at the 4th week. **Measure:** Severity of Disability **Time Frame:** 12 Months **Description:** assessed by using modified sphygmomanometer in which it first inflated to 100 mmHg with closed valve. The pressure was reduced to 20mmHg and the resisted wrist extension performed at baseline and at the 4th week. **Measure:** Grip strength: **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age: 20-50 years * Gender: Male and Female * Pain on the lateral epicondyle * VAS scoring more than 4 * Positive test: Tomson test, Mill's test , Cozen;s sign and Maudsley's test Exclusion Criteria: * Any neurological/ Radiculopathy signs in upper limb * Cervical pain * Bilateral elbow pain * History of elbow or wrist surgery * Receiving any corticosteroid injection within last 6 months **Maximum Age:** 50 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bhakkar **Country:** Pakistan **Facility:** Fatima medical center near green town **State:** Punjab ### 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: BC10 - Name: Nervous System Diseases ### 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: 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 ### 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:** NCT06438315 **Acronym:** SSCORE **Brief Title:** SuperSaturated Oxygen Comprehensive Observational Registry **Official Title:** SuperSaturated Oxygen Comprehensive Observational Registry #### Organization Study ID Info **ID:** EDC-5731 #### Organization **Class:** INDUSTRY **Full Name:** TherOx ### Status Module #### Completion Date **Date:** 2029-03-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-30 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** TherOx #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The SuperSaturated Oxygen Comprehensive Observational Registry (SSCORE) registry, a prospectively designed observational study, aims to evaluate the clinical utility and effectiveness of SuperSaturated Oxygen (SSO2) Therapy versus percutaneous coronary intervention (PCI) alone among patients with anterior acute myocardial infarction (AMI) in routine clinical practice. The goal is to collect real-world data from patients treated with SSO2 Therapy to determine its impact on the overall heart failure (HF) burden on patients and healthcare systems compared with usual care for treatment of patients with AMI. The SSCORE Registry will generate effectiveness and healthcare resource utilization data that will be used in cost-effectiveness analysis modeling. ### Conditions Module **Conditions:** - STEMI - ST Elevation Myocardial Infarction - AMI ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 1000 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 2 Years ### Arms Interventions Module #### Arm Group 1 **Description:** Treated with SSO2 **Intervention Names:** - Other: No intervention **Label:** SuperSaturated Oxygen (SSO2) Therapy #### Arm Group 2 **Description:** Not treated with SSO2 **Intervention Names:** - Other: No intervention **Label:** Control ### Interventions #### Intervention 1 **Arm Group Labels:** - Control - SuperSaturated Oxygen (SSO2) Therapy **Description:** No intervention **Name:** No intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Rate of composite of CV death, new onset HF, any new inpatient or outpatient treatment for HF, or worsening of HF **Measure:** Cardiovascular (CV) death or Heart Failure (HF) burden at 1 year **Time Frame:** 1 year #### Secondary Outcomes **Description:** Days to the composite of CV death, new onset HF, any new inpatient or outpatient treatment for HF, or worsening of HF **Measure:** Time to Cardiovascular (CV) death or HF burden **Time Frame:** 2 years **Description:** Rate of all cause mortality **Measure:** Rate of all cause mortality **Time Frame:** 2 years **Description:** Rate of All-cause Hospitalization **Measure:** Rate of All-cause Hospitalization **Time Frame:** 2 years **Description:** Rate of cardiovascular death **Measure:** Rate of cardiovascular death **Time Frame:** 2 years **Description:** Rate of Hospitalization for Heart Failure **Measure:** Rate of Hospitalization for Heart Failure **Time Frame:** 2 years **Description:** composite of rates of CV death, reinfarction, or HF hospitalization **Measure:** Major Adverse Cardiovascular Events (MACE) **Time Frame:** 2 years **Description:** Rate of Reinfarction **Measure:** Rate of Reinfarction **Time Frame:** 2 years **Description:** Patient reported outcome, 0 to1, where 0 is death and 1 is perfect health **Measure:** Change in EQ5D-3L Score **Time Frame:** 2 years **Description:** Heart related patient reported outcome, scaled from 0 to 100, with 0 representing the worst symptoms and function and 100 representing the best **Measure:** Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-23) Score **Time Frame:** 2 years **Description:** Rate of change of LVEF from baseline to time point **Measure:** Change in % of Left ventricular ejection fraction (LVEF) **Time Frame:** 2 years **Description:** Rate of change of NHYA classification from baseline to time point **Measure:** Change in New York Heart Association (NYHA) classification scale, I-IV **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Men or women aged 18 years or older * Presentation with acute myocardial infarction (AMI) and successful revascularization of the infarct-related artery with percutaneous coronary intervention (PCI) * The subject or their legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided and signed written informed consent, approved by the appropriate Institutional Review Board (IRB) Exclusion Criteria: * Life expectancy of less than 2 years * No access to medical records from either the index hospitalization or subsequent outpatient visits * Currently participating in an investigational drug or device trial **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study will aim to prospectively enroll 500 subjects not treated with SuperSaturated Oxygen (SSO2) Therapy (Prospective Control Cohort), 500 subjects who received SSO2 Therapy in accordance with the product label (SSO2 Treated On-Label) and any subjects that receive SSO2 at an institution that meet criteria inclusion/exclusion (IE) criteria. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jgardner@zoll.com **Name:** Jennifer Gardner **Phone:** 949-300-2811 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Henry Ford Hospital **Name:** William W O'Neill, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Stone GW, Martin JL, de Boer MJ, Margheri M, Bramucci E, Blankenship JC, Metzger DC, Gibbons RJ, Lindsay BS, Weiner BH, Lansky AJ, Krucoff MW, Fahy M, Boscardin WJ; AMIHOT-II Trial Investigators. Effect of supersaturated oxygen delivery on infarct size after percutaneous coronary intervention in acute myocardial infarction. Circ Cardiovasc Interv. 2009 Oct;2(5):366-75. doi: 10.1161/CIRCINTERVENTIONS.108.840066. Epub 2009 Sep 15. **PMID:** 20031745 **Citation:** David SW, Khan ZA, Patel NC, Metzger DC, Wood FO, Wasserman HS, Lotfi AS, Hanson ID, Dixon SR, LaLonde TA, Genereux P, Ozan MO, Maehara A, Stone GW. Evaluation of intracoronary hyperoxemic oxygen therapy in acute anterior myocardial infarction: The IC-HOT study. Catheter Cardiovasc Interv. 2019 Apr 1;93(5):882-890. doi: 10.1002/ccd.27905. Epub 2018 Sep 28. **PMID:** 30265429 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007511 - Term: Ischemia - ID: D000010335 - Term: Pathologic Processes - ID: D000009336 - Term: Necrosis - ID: D000017202 - Term: Myocardial Ischemia - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000014652 - Term: Vascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12155 - Name: Myocardial Infarction - Relevance: HIGH - As Found: Myocardial Infarction - ID: M10282 - Name: Infarction - Relevance: HIGH - As Found: Infarction - ID: M1072 - Name: ST Elevation Myocardial Infarction - Relevance: HIGH - As Found: ST Elevation Myocardial Infarction - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M12284 - Name: Necrosis - Relevance: LOW - As Found: Unknown - ID: M6546 - Name: Coronary Artery Disease - Relevance: LOW - As Found: Unknown - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009203 - Term: Myocardial Infarction - ID: D000072657 - Term: ST Elevation Myocardial Infarction - ID: D000007238 - Term: Infarction ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438302 **Acronym:** VENTINA **Brief Title:** Effects of Nasal Ventilation on Cerebral and Pulmonary Function in Orally Intubated Patients **Official Title:** Effects of Nasal Ventilation on Cerebral and Pulmonary Function in Orally Intubated Patients #### Organization Study ID Info **ID:** APHP240271 #### Organization **Class:** OTHER **Full Name:** Assistance Publique - Hôpitaux de Paris ### Status Module #### Completion Date **Date:** 2025-06-22 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-22 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-21 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assistance Publique - Hôpitaux de Paris #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The passage of air through the nasal cavity generates rhythmic oscillations transmitted by the olfactory bulb to the brain, which induces cerebral activation in functional areas and is associated with better cognitive performance compared to oral breathing. Consequently, the abolition of nasal ventilation in patients intubated via the orotracheal route could have deleterious effects on brain activity. Besides the loss of olfaction, the abolition of nasal ventilation could affect brain activity and respiratory control, consequently altering regional pulmonary ventilation. The hypothesis of the study is that nasal ventilation through the passage of humidified nasal airflow in patients intubated via the orotracheal route would be associated with modulation of cerebral electrical activity and tissue oxygenation and a modification of regional pulmonary ventilation. **Detailed Description:** The effects of nasal ventilation on cerebral activity will be studied on orally intubated and sedated patients in six experimental conditions. The first condition consists of nociceptive stimulation of the left upper limb as a negative control. In three conditions, the inspired fraction of oxygen (FiO2) will remain at 21% while applying three different rates of humidified nasal air at 0L/min, 30L/min and 60L/min respectively. The last two conditions consist of applying humidified nasal air at 30L/min and 60L/min with a FiO2 of 100%. The primary objective of this study is to evaluate the effects of high-flow humidified nasal air on electroencephalogram activity (root mean square gamma frequency) in sedated, orally intubated patients. The secondary objectives of the study are to evaluate the effects of high-flow humidified nasal air on cerebral perfusion and oxygenation, gas exchange and regional pulmonary ventilation in the same patients. ### Conditions Module **Conditions:** - Hypoxemic Acute Respiratory Failure **Keywords:** - nasal ventilation - orotracheal intubation - brain activity ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 22 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The study population will be adult patients with acute respiratory failure who are orally intubated and sedated. These patients should be free of neurological and psychiatric diseases prior to ICU admission. The choice of this particular population is justified by its exposure to mechanical ventilation and continuous sedation, which are recognized risk factors for brain damage. **Intervention Names:** - Device: EEG activity measurement **Label:** Major mechanically ventilated patients intubated orotracheally ### Interventions #### Intervention 1 **Arm Group Labels:** - Major mechanically ventilated patients intubated orotracheally **Description:** The nasal ventilation device (placed as part of the research) (AIRVO 2; Fisher and Paykel Healthcare, Auckland, New Zealand) will be positioned via nasal cannulas adapted to the patient's anatomy. The FiO2 will be set at 21% and the flow rate will be fixed at 0 L/min at the inclusion visit. The temperature of the humidified nasal oxygenator will be set at 37°C. Six 30-minute experimental conditions will be performed successively: 1) 0 L/min flow, FiO2 21%, 2) 30 L/min flow, FiO2 21%, 3) 30 L/min flow, FiO2 100%, 4) 60 L/min flow, FiO2 21%, 5) 60 L/min flow, FiO2 100%, 6) Negative control. At the end of each condition, a 10-minute thoracic electrical impedance tomography recording, a 10-minute EEG recording, a 10-minute cerebral NIRS recording and an instantaneous temporal Doppler velocity measurement will be performed. A blood gas (1.5 mL) will also be taken at the end of each condition. **Name:** EEG activity measurement **Other Names:** - Post-intubation nasal ventilation - Additional blood samples (from care catheter 1.5 mL) - Electrical impedance tomography **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** EEG spectral density spectrum of gamma frequency. **Measure:** Study the effects of nasal ventilation on brain electrical activity using electroencephalogram recording (EEG) in sedated orotracheally intubated patients. **Time Frame:** At inclusion (day 1) - step 1 to 6 #### Secondary Outcomes **Description:** This outcome will be assessed by the evaluation of the Index of Pulsatility (IP) (IP=(Vs-Vd)/Vm: Vs: Systolic velocity; Vd: Diastolic Velocity; Vm: Mean Velocity) **Measure:** Study the effects of nasal ventilation on cerebral perfusion **Time Frame:** At inclusion (day 1) - step 1 to 6 **Description:** Cerebral tissue oxygenation (% of O2) measured by NIRS (Near Infrared Spectroscopy) electrodes **Measure:** Study the effects of nasal ventilation on cerebral tissue oxygenation **Time Frame:** At inclusion (day 1) - step 1 to 6 **Description:** Ratio of PaO2 (partial pressure of O2) /FiO2 (inspired oxygen fraction) **Measure:** Study the effects of nasal ventilation on gas exchange **Time Frame:** At inclusion (day 1) - step 1 to 6 **Description:** Evaluation of PaCO2 (partial pressure of CO2) (mmHG) **Measure:** Study the effects of nasal ventilation on gas exchange **Time Frame:** At inclusion (day 1) - step 1 to 6 **Description:** Evaluation of impedance variation by thoracic electrical impedance tomography. **Measure:** Study the effects of nasal ventilation on regional lung ventilation distribution **Time Frame:** At inclusion (day 1) - step 1 to 6 **Description:** Evaluation of ventilation homogeneity by I thoracic electrical impedance tomography. **Measure:** Study the effects of nasal ventilation on regional lung ventilation distribution **Time Frame:** At inclusion (day 1) - step 1 to 6 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age ≥ 18 years old 2. Hypoxemic acute respiratory failure 3. Intubation and mechanical ventilation since less than 4 days 4. PaO2/FiO2 ratio less than 150 5. RASS\<-4 6. Consent obtained from next of kin 7. Patient with health insurance Exclusion Criteria: 1. Central nervous system diseases (stroke, MS, epilepsy) 2. Psychiatric illnesses (psychosis, depression) (indicated on patient's medical record) 3. Hemodynamic instability (noradrenalin\>2mg/h) 4. Patient on AME 5. Patients under legal protection (guardianship/curators) 6. Pregnant or breast-feeding women **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study population will be adult patients with acute respiratory failure who are orally intubated and sedated. These patients should be free of neurological and psychiatric diseases prior to ICU admission. The choice of this particular population is justified by its exposure to mechanical ventilation and continuous sedation, which are recognized risk factors for brain damage. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** martin.dres@aphp.fr **Name:** Martin Dres **Phone:** 0142167809 **Role:** CONTACT ### IPD Sharing Statement Module **Access Criteria:** Researchers who provide a methodologically sound proposal. **Description:** The procedures carried out with the French data privacy authority (CNIL, "Commission nationale de l'informatique et des libertés") do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations **Info Types:** - STUDY_PROTOCOL - ICF **IPD Sharing:** YES **Time Frame:** Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012120 - Term: Respiration Disorders - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14968 - Name: Respiratory Insufficiency - Relevance: HIGH - As Found: Hypoxemic Acute Respiratory Failure - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012131 - Term: Respiratory Insufficiency ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438289 **Acronym:** DISLOTIP **Brief Title:** Ultrasound to Investigate Tip Dislodgment of Epicutaneous-caval Catheter. **Official Title:** Use of Ultrasound to Investigate Tip Dislodgment of Epicutaneous-caval Catheter: a Multicentric Study #### Organization Study ID Info **ID:** Protocol 335 #### Organization **Class:** OTHER **Full Name:** Federico II University ### Status Module #### Completion Date **Date:** 2025-01-17 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-01-17 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-17 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **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:** Federico II University #### Responsible Party **Investigator Affiliation:** Federico II University **Investigator Full Name:** Francesco Raimondi **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a non-pharmacological, non-profit, prospective, observational multicenter study. Primarily, the study aims to demonstrate the feasibility of ultrasound methodology to study the secondary malposition of epicutaneous-caval catheters (ECC) in neonates. After obtaining informed consent, the study involves performing ultrasound tip location on newborns who had an ECC placed. This will occur immediately after the placement and, if in a central position, subsequently at 60-120 minutes, 48-72 hours and 6-8 days post-placement. Data will be collected on various variables. Each Center will contribute at least 20 cases to the cohort and all data will be recorded in a database. The study is expected to last for 12 months **Detailed Description:** Epicutaneous-caval catheters (ECCs) are among the most common central venous catheters used in neonatology. It is known that they can experience malpositioning over time from the moment of placement, leading to complications. In all studies conducted so far, tip location has been performed using X-ray. Ultrasound would be the ideal method for serial, bedside and radiatIon-free evaluation of ECC tip location to intercept any migrations. The primary endpoint of the study is to demonstrate the feasibility of ultrasound method for the assessment of secondary ECC malposition. Secondary endpoints include validating the results of previous Investigators monocentric study on the feasibility of ultrasound tip location applied to ECC and establishing the incidence of secondary malpositioning and the optimal timing for reassessing tip position after ECC placement. All neonates undergoing placement of 28 Gauge/1 French ECCs with a standardized securement system are included in the study, while neonates with major malformation are excluded. The study includes: obtaining written informed consent; performing ultrasound tip location using a standardized protocol (high right parasternal, apical four-chamber, short-axis left parasternal and bicaval subcostal views); If the tip is in a central position, repeating ultrasound tip location (using the same protocol) at 60-120 minutes, 48-72 hours and 6-8 days post-placement; collecting variables including sex, site of ECC insertion, weight at placement and at each tip location, postmenstrual age at placement and at each tip location, days of life at placement and at each tip location, respiratory support at placement and at each tip location, feasibility of ultrasound tip location for each ECC and for each specified time, ultrasound tip location result for each ECC and for each specified time and any displacement relative to the time of placement, as wall as any reported complications associated with secondary malpositioning. All ultrasound will be performed with the newborn in a standardized position: limb adducted and elbow extended if the catheter is placed from the upper limb, limb adducted and knee extended if the catheter is placed from the lower limb, neutral position if the catheter is placed from the scalp. The records of the ultrasound exams at each time for the first five cases enrolled by each Center will be sent to the Coordinator Center for evaluation of protocol compliance. Using the exact binomial method and setting a margin of error of 4% for a 95% of confidence interval, the investigators calculated that the sample size should be 196. The collected data will be recorded anonymously in an Excel database. Continuous variables will be expressed as means with minimum and maximum ranges, while categorical variables will be expressed as frequencies with percentages. Each case will be identified with an alphanumeric code to ensure data confidentiality. The principal investigator is the only person able to link the code to the identity of the patient. Parents, relative or guardians of eligible patients will be provided with all explanations regarding the experimental protocol by the study staff before enrollment. Information will be provided and parents will be given up to 12 hours to give their consent. The principal investigator will be responsible for the overall monitoring of data and the safety of the study participants. No funding or additional costs beyond common current practice are anticipated. ### Conditions Module **Conditions:** - Migration of Implant or Internal Device **Keywords:** - tip location - ultrasound - epicutaneous-caval catheter - tip secondary migration - newborn - ECC ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 196 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** percentage, from 0% to 100% **Measure:** Percentage of cases in which ultrasound tip location is feasible to study ECC secondary malposition **Time Frame:** 8 days from the ECC placement ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * neonates undergoing placement of 28 G/1 Fr ECCs with a standardized securement system Exclusion Criteria: * neonates with major malformation **Healthy Volunteers:** True **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** neonates undergoing placement of 28G/1 Fr ECCs with a standardized securement system ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** raimondi@unina.it **Name:** Francesco Raimondi **Phone:** +393392683848 **Role:** CONTACT **Contact 2:** **Email:** fiorentino.grasso89@gmail.com **Name:** Fiorentino Grasso **Phone:** +393290710660 **Role:** CONTACT #### Locations **Location 1:** **City:** Naples **Contacts:** ***Contact 1:*** - **Email:** raimondi@unina.it - **Name:** Francesco Raimondi, Professor - **Phone:** +393392683848 - **Role:** CONTACT ***Contact 2:*** - **Email:** fiorentino.grasso89@gmail.com - **Name:** Fiorentino Grasso, MD - **Phone:** +393290710660 - **Role:** CONTACT **Country:** Italy **Facility:** AOU Federico II- Neonatal Intensive Care Unit **Status:** RECRUITING **Zip:** 80131 ### References Module #### References **Citation:** Practice Guidelines for Central Venous Access 2020: An Updated Report by the American Society of Anesthesiologists Task Force on Central Venous Access. Anesthesiology. 2020 Jan;132(1):8-43. doi: 10.1097/ALN.0000000000002864. No abstract available. **PMID:** 31821240 **Citation:** Barone G, Pittiruti M. Epicutaneo-caval catheters in neonates: New insights and new suggestions from the recent literature. J Vasc Access. 2020 Nov;21(6):805-809. doi: 10.1177/1129729819891546. Epub 2019 Dec 5. **PMID:** 31804149 **Citation:** Costello JM, Clapper TC, Wypij D. Minimizing complications associated with percutaneous central venous catheter placement in children: recent advances. Pediatr Crit Care Med. 2013 Mar;14(3):273-83. doi: 10.1097/PCC.0b013e318272009b. **PMID:** 23392365 **Citation:** de Jonge RC, Polderman KH, Gemke RJ. Central venous catheter use in the pediatric patient: mechanical and infectious complications. Pediatr Crit Care Med. 2005 May;6(3):329-39. doi: 10.1097/01.PCC.0000161074.94315.0A. **PMID:** 15857534 **Citation:** Acun C, Baker A, Brown LS, Iglesia KA, Sisman J. Peripherally inserted central cathether migration in neonates: Incidence, timing and risk factors. J Neonatal Perinatal Med. 2021;14(3):411-417. doi: 10.3233/NPM-200684. **PMID:** 33459671 **Citation:** Gupta R, Drendel AL, Hoffmann RG, Quijano CV, Uhing MR. Migration of Central Venous Catheters in Neonates: A Radiographic Assessment. Am J Perinatol. 2016 May;33(6):600-4. doi: 10.1055/s-0035-1570341. Epub 2016 Jan 5. **PMID:** 26731179 **Citation:** Srinivasan HB, Tjin-A-Tam A, Galang R, Hecht A, Srinivasan G. Migration patterns of peripherally inserted central venous catheters at 24 hours postinsertion in neonates. Am J Perinatol. 2013 Nov;30(10):871-4. doi: 10.1055/s-0033-1333672. Epub 2013 Feb 4. **PMID:** 23381907 **Citation:** Grasso F, Capasso A, Pacella D, Borgia F, Salome S, Capasso L, Raimondi F. Ultrasound Guided Catheter Tip Location in Neonates: A Prospective Cohort Study. J Pediatr. 2022 May;244:86-91.e2. doi: 10.1016/j.jpeds.2021.12.059. Epub 2021 Dec 28. **PMID:** 34971654 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12307 - Name: Neoplasm Metastasis - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438276 **Acronym:** JAPSY **Brief Title:** Psychiatric Outreach Nurses Supporting Adolescent Mental Health **Official Title:** Supporting Adolescent Mental Health by Psychiatric Outreach Nurses: A Mixed Method Evaluation Study #### Organization Study ID Info **ID:** JAPSY_20230 #### Organization **Class:** OTHER **Full Name:** University of Eastern Finland ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-06 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Wellbeing Services County of North Savo **Class:** UNKNOWN **Name:** The Foundation for Municipal Development #### Lead Sponsor **Class:** OTHER **Name:** University of Eastern Finland #### 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 evaluates the effectiveness and cost-effectiveness of the outreach work of psychiatric registered nurses (RN) and the experiences of professionals in the field. The service is provided in school environment. First, the study will assess the effectiveness of brief interventions provided by psychiatric outreach nurses on the perceived mental health and quality of life of adolescents (12-16 year old pupils) and their use of social and health services, compared to the support/treatment provided by conventional student welfare services at 6 and 12 months follow-up. The intervention is an outreach service provided by psychiatric nurses. In the intervention, the psychiatric registered nurse will implement interventions such as usual care, discussion, psychoeducation, substance abuse skills and various methods (such as interpersonal psychotherapy = IPT-N and Cool Kids) and motivational interviewing. Secondly, an economic evaluation of the service will be carried out at 6 and 12 months follow-up. The economic evaluation will be carried out from the perspective of the Wellbeing Services County, including the costs of implementing the intervention model and its effects on adolescents' use of student welfare services as well as other social and health services. Primarily, the economic evaluation will use quality-weighted life years as a measure of effectiveness. Also analysis using depression, anxiety and substance use measures will be conducted. Thirdly, the study will explore the experiences of psychiatric nurses implementing the service as well as the experiences of their collaborators in schools (public health nurses, school social workers, psychologists, doctors and teachers) about the service and its implementation. **Detailed Description:** Quantitative research data will be used to evaluate the effectiveness of the psychiatric outreach care compared to conventional care (TAU). Psychiatric outreach registered nurses are currently available in some schools in several municipalities in the North Savo region in Finland. In the other schools, support is provided by so-called "usual" counselling and other support/treatment, e.g. by public health nurses, school social workers, school psychologists and school doctors. The study design is a clustered controlled setting. The target sample size for quantitative data is 160 participants. The intervention group (n = 80) will consist of pupils receiving support/treatment from psychiatric outreach nurses. The control group (n = 80) will consist of pupils whose schools provide standard student welfare services and whose mental health status and support needs are similar to those of the intervention group. The data will be collected through questionnaires administered to secondary school pupils to assess their mental health status and quality of life. The adolescents' service use in terms of student welfare services as well as Wellbeing Services County's social and health care services will be collected through questionnaires. At baseline, the use of services will be surveyed retrospectively over a six-month period. The primary outcome variable of the intervention is the adolescent's perceived mental health status as assessed by the PHQ-9-A (Patient Health Questionnaire) measure of depression and the GAD-7 (generalized anxiety disorder) measure of anxiety. The secondary outcome variables are the adolescent's perceived quality of life (EQ-5D-Y, five dimensional quality of life measure) and substance use (ADSUME, Adolescents´ Substance Use Measurement). The study will primarily investigate the effect of psychiatric outreach nurses on treatment response. Secondarily, subgroups of at least 20 participants will be examined (e.g. controls for gender, age or other background variables). Participants are assigned to the intervention or control group based on whether the services of an psychiatric outreach nurse is available in their school (intervention) or not (control). For similarities and differences between the intervention and control groups, a descriptive analysis is performed using the chi-square test to compare categorical variables and the t-test or Mann-Whitney U-test to compare continuous variables. The effectiveness of the intervention will be analysed using statistical methods appropriate for panel data, taking into account the effects of possible correlation/multicollinearity on the results. Statistical methods will be used to control for the possible selection of a non-standardised design by including control variables in the models. The economic evaluation of the intervention will use data on the use of social and health services, student welfare services and the cost of the intervention. Data on the costs of the intervention will be obtained from the Wellbeing Services County of North Savo. The costs of health and social services and student welfare services are calculated on the basis of the number of services used and the unit costs. The cost-effectiveness of the intervention is analysed in relation to the treatment as usual provided by student welfare services using incremental net monetary benefit or incremental net health benefit evaluation to examine differences in costs and/or health benefits between groups and in the above-mentioned outcomes at 6-month and 12-month follow-up. Primarily, the economic evaluation will use the EQ-5D-Y measure to calculate quality-weighted life-years. In addition, the results of the PHQ-9-A, GAD-7 and ADSUME measures will be analysed. Eligibility Criteria: Pupils (12-16 years old) who seek help from a student welfare service due to mood disorders. In addition, a representative of the student welfare service (e.g. a public health nurse, school social worker, psychologist or doctor) or a representative of the student welfare service and an psychiatric outreach nurse assess together a person's eligibility for the study, taking into account the inclusion and exclusion criteria. Inclusion criteria for the intervention and control groups will be one or more of the following symptoms: prolonged and/or complicated anxiety, mood symptoms, obsessive-compulsive and/or eating disorder symptoms, mild to moderate self-harm (e.g. death wishes or cutting). In addition, the young person's motivation to receive the service is an admission criterion. Exclusion criteria: The psychiatric outreach nurse service is not suitable for persons with one or more of the following needs or life situations: pupils who need light support and guidance, young people with a single problem of low motivation for school, young people with a stressful life situation or relationship problems. On the other hand, the service is not intended for pupils who are in acute need of specialist care or for pupils with multidisciplinary problems for whom support measures have already been put in place, because of their mental health symptoms (e.g. severe depression, psychotic symptoms, severe and acute suicidal tendencies or a clear suicide plan). Exclusion criteria for the intervention and control groups also include situations where the young person has a long-lasting, already established mental health problem and/or a need for further treatment after a period of specialised hospital care. Exclusion criteria also include behavioural disorders where there is a clear underlying cause other than a mental disorder. The qualitative perspective of the study focuses on those implementing the service (psychiatric outreach nurses) and their collaborators in schools (e.g. school social workers, public health nurses, school psychologists, doctors and teachers). The total number of interviewees is estimated to be 15-20. Data collection consists of individual semi-structured interviews to describe the interviewees' experiences of applying the new service approach in the school setting. As the approach is new in the Wellbeing Services County of North Savo, it is necessary to explore the experiences of both those implementing as well as their collaborators in terms of introducing the service, operation of the service, the perceived needs for the service as well as the needs for development of the service. The interviews will be carried out at the beginning of the study and at 12-month follow-up. ### Conditions Module **Conditions:** - Depression - Anxiety **Keywords:** - mental health - mental disorders - adolescent - outreach service - school-based - effectiveness - economic evaluation ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 160 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Intervention group receiving psychiatric outreach nurse services: adolescents (12-16 years old) who seek help from student welfare services due to mood disorders and have access to psychiatric outreach nurse's service. Control group receiving TAU: adolescents (12-16 years old) who seek help from student welfare services due to mood disorders and have no access to psychiatric outreach nurse's service. **Intervention Names:** - Behavioral: Psychiatric outreach nurse service **Label:** Adolescents with mood disorders seeking help in student welfare services ### Interventions #### Intervention 1 **Arm Group Labels:** - Adolescents with mood disorders seeking help in student welfare services **Description:** Mental health service provided by psychiatric outreach nurses for 12-16 year old students in secondary schools **Name:** Psychiatric outreach nurse service **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The effects of the outreach psychiatric nurse service on adolescent's perceived mental health status assessed by the Patient Health Questionnaire modified for adolescent (PHQ-9-A) measure of depression in 6-month and 12-month follow-up. The minimum value of the measure is 0 and maximum value 27. Higher scores is worse outcome. **Measure:** Patient Health Questionnaire modified for adolescent to measure perceived mental health **Time Frame:** 6-month and 12-month follow-up **Description:** The effects of the outreach psychiatric nurse service on adolescent's perceived mental health status assessed by the Generalized Anxiety Disorder 7-item (GAD-7) measure of anxiety in 6-month and 12-month follow-up. The minimum value of the measure is 0 and maximum value 21. Higher scores is worse outcome. **Measure:** Generalized Anxiety Disorder 7-item to measure adolescent's perceived mental health **Time Frame:** 6-month and 12-month follow-up #### Secondary Outcomes **Description:** The effects of the outreach psychiatric nurse service on adolescent's perceived quality of life and substance use assessed by EuroQol- 5-Dimension 3-Level modified for adolescent (EQ-5D-Y-3L) measure in 6-month and 12-month follow-up. EQ-5D-Y will be converted to index-values \[theoretical range 0-1\] by using suitable value set. The higher value means better health related quality of life. **Measure:** EuroQol-5-Dimension 3-Level modified for adolescent to measure perceived quality of life **Time Frame:** 6-month and 12-month follow-up **Description:** The effects of the outreach psychiatric nurse service on adolescent's substance use assessed by Adolescents' Substance Use Measurement (ADSUME) measure in 6-month and 12-month follow-up.The minimum value of the measure is 0 and maximum value 90. Higher scores is worse outcome **Measure:** Adolescents' Substance Use Measurement to measure substance use **Time Frame:** 6-month and 12-month follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adolescents (12-16 years old) who seek help from student welfare services due to mood disorders and who have one or more of the following conditions: prolonged and/or complicated anxiety, mood symptoms, obsessive-compulsive and/or eating disorder symptoms, mild to moderate self-harm (e.g. death wishes or cutting). In addition, person's motivation to receive the service provided is an admission criterion. Exclusion Criteria: * Persons with one or more of the following needs or life situations: adolescents who need light support and guidance, young people with a single problem of low motivation for school, young people with a stressful life situation or relationship problems. On the other hand, adolescents who are in acute need of specialist care or for adolescents with multidisciplinary problems for whom support measures have already been put in place, because of their mental health symptoms (e.g. severe depression, psychotic symptoms, severe and acute suicidal tendencies or a clear suicide plan). * Exclusion criteria for the intervention and control groups also include situations where the adolescent has a long-lasting, already established mental health problem and/or a need for further treatment after a period of specialised hospital care. * Exclusion criteria also include behavioural disorders where there is a clear underlying cause other than a mental disorder. **Maximum Age:** 16 Years **Minimum Age:** 12 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD **Study Population:** Adolescent (12-16 year old) students of secondary schools in the municipalities of North Savo Wellbeing County who seek help from student welfare services due to mood disorders. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** anne.surakka@uef.fi **Name:** Anne Surakka, M.Soc.Sc, MHS (Health Econ.) **Phone:** +358505292553 **Role:** CONTACT #### Locations **Location 1:** **City:** Kuopio **Contacts:** ***Contact 1:*** - **Email:** sanna.kukkonen@pshyvinvointialue.fi - **Name:** Sanna Kukkonen, MHS - **Phone:** +35817173311 - **Role:** CONTACT ***Contact 2:*** - **Email:** sanna.voutilainen@pshyvinvointialue.fi - **Name:** Sanna Voutilainen - **Phone:** +35817173311 - **Role:** CONTACT **Country:** Finland **Facility:** Wellbeing Services County of North Savo **State:** North Savo **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** University of Eastern Finland **Name:** Johanna Lammintakanen, PhD, Professor **Role:** PRINCIPAL_INVESTIGATOR ### 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: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - 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:** NCT06438263 **Brief Title:** A Study to Evaluate Bioavailability of Rocatinlimab Autoinjector and Vial in Healthy Participants **Official Title:** An Open-label, Phase 1, Single Dose, Randomized, Parallel-group Study to Assess the Relative Bioavailability of Rocatinlimab (AMG 451) Autoinjector and Vial in Healthy Subjects #### Organization Study ID Info **ID:** 20220014 #### Organization **Class:** INDUSTRY **Full Name:** Amgen ### Status Module #### Completion Date **Date:** 2025-01-16 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-01-16 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Amgen #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** The main objective of this study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) autoinjector dose compared to vial in healthy participants. ### Conditions Module **Conditions:** - Atopic Dermatitis **Keywords:** - Rocatinlimab ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 230 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will be randomized to receive a single dose of rocatinlimab vial solution for SC injection. **Intervention Names:** - Drug: Rocatinlimab **Label:** Treatment A **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will be randomized to receive a single dose of rocatinlimab autoinjector for SC injection. **Intervention Names:** - Drug: Rocatinlimab **Label:** Treatment B **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment A **Description:** Vial supplied as a single-use preservative free solution for SC injection. **Name:** Rocatinlimab **Other Names:** - AMG 451 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Treatment B **Description:** Autoinjector for SC injection. **Name:** Rocatinlimab **Other Names:** - AMG 451 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Maximum Plasma Concentration (Cmax) of Rocatinlimab **Time Frame:** Up to approximately 112 days **Measure:** Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab **Time Frame:** Up to approximately 112 days **Measure:** AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab **Time Frame:** Up to approximately 112 days #### Secondary Outcomes **Description:** TEAEs are any adverse events (AEs) that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECG), and clinical laboratory tests that occurred after study treatment administration will be recorded as TEAEs. A serious AE (SAE) is defined as any AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above. **Measure:** Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) **Time Frame:** Approximately 20 weeks **Measure:** Number of Participants with Anti-rocatinlimab Antibodies **Time Frame:** Up to approximately Day 112 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Participant has provided informed consent before initiation of any study-specific activities/procedures. 2. Healthy male or female participants, between 18 and 65 years of age (inclusive) 3. Body mass index between 18 and 32 kg/m2 (inclusive) Exclusion Criteria: 1. History or evidence, at Screening or Check-in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion. 2. History or evidence of clinically significant arrhythmia at Screening, including any clinically significant findings on the ECG taken at Check-in. 3. A QT interval corrected for heart rate using Fridericia's method (QTcF) \> 450 msec in male participants or \> 470 msec in female participants or history/evidence of long QT syndrome at Screening or Check-in. 4. Systolic blood pressure ≥ 140 mmHg or ≤ 90 mmHg, or diastolic blood pressure ≥ 90 mmHg or ≤ 50 mmHg, or pulse rate ≥ 100 bpm or ≤ 40 bpm 5. History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Participants with seasonal allergies will be permitted. 6. Estimated glomerular filtration rate less than 70 mL/min/1.73 m2 7. Alanine aminotransferase or aspartate aminotransferase \> 1.5 times the upper limit of normal at Screening or Check-in. 8. Positive hepatitis B or hepatitis C panel (including positive hepatitis B surface antigen \[HBsAg\] and/or positive hepatitis C antibody) and/or positive human immunodeficiency virus test at Screening. Participants whose results are compatible with prior hepatitis B vaccination (positive hepatitis B surface antibody, negative hepatitis B core antibody, negative HBsAg) or prior infection (positive hepatitis B core antibody, positive hepatitis B surface antibody, negative HBsAg) may be included. 9. Participants who have received live vaccines within 5 weeks prior to Screening, or plan to receive live vaccines within 90 days after administration of an investigational product. Inactive vaccination (e.g., non-live or nonreplicating agent), including coronavirus-2019 (COVID-19) vaccination, is allowed. 10. History of latent tuberculosis or active chronic, recurrent, or acute infection requiring treatment with systemic antibiotics, antiviral, antiparasitic, antiprotozoal, or antifungals which has not completely resolved, or for which therapy has not been completed, within 4 weeks before Screening. 11. Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before Check-in, excluding the following: 1. Acetaminophen (paracetamol) (up to 2 g per day) for analgesia will be allowed. 2. Hormonal contraception listed in Appendix 3 will be allowed. 3. Hormone replacement therapy (e.g., estrogen) and hormonal contraceptives will be allowed. 12. All herbal medicines (e.g., St. John's wort), vitamins, and supplements consumed by the participant within the 30 days prior to Check-in, unless deemed acceptable by the Investigator (or designee) and in consultation with the Sponsor. 13. Participant has received a dose of an investigational drug within the past 90 days or 5 half-lives, whichever is longer, prior to Check-in. 14. Have previously completed or withdrawn from this study or any other study investigating rocatinlimab or have previously received rocatinlimab. **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:** medinfo@amgen.com **Name:** Amgen Call Center **Phone:** 866-572-6436 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Amgen **Name:** MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below. **Description:** De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES **Time Frame:** Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study. **URL:** http://www.amgen.com/datasharing ### References Module #### See Also Links **Label:** AmgenTrials clinical trials website **URL:** http://www.amgentrials.com ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7071 - Name: Dermatitis, Atopic - Relevance: LOW - As Found: Unknown - ID: M7067 - Name: Dermatitis - Relevance: HIGH - As Found: Dermatitis - ID: M7655 - Name: Eczema - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003872 - Term: Dermatitis ### 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:** NCT06438250 **Brief Title:** 68Ga-FAPI-JH04 PET/CT: Dosimetry and Biodistribution Studies **Official Title:** 68Ga-FAPI-JH04 PET/CT: Dosimetry and Biodistribution Study in Patients With Various Cancers #### Organization Study ID Info **ID:** FirstAHFujian-68Ga-FAPI-JH04 #### Organization **Class:** OTHER **Full Name:** First Affiliated Hospital of Fujian Medical University ### Status Module #### Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** First Affiliated Hospital of Fujian Medical University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** 68Ga-FAPI-JH04 is a novel radiotracer targeting fibroblast activation protein (FAP). In this study, we observed the safety, biodistribution, and radiation dosimetry of 68Ga-JH040182 in patients with different types of cancer. **Detailed Description:** Carcinoma-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment, and fibroblast activation protein (FAP), as a specific marker of CAFs, is overexpressed in more than 90% of epithelial malignant tumors' CAFs, with limited expression in normal tissues, making it an appropriate target for various tumors. Currently, several tracers targeting FAP for diagnostic purposes have been developed, such as 68Ga-FAPI-04, 68Ga-FAPI-02, and showed high efficacy in tumor staging and restaging. 68Ga-FAPI-JH04, a novel radiopharmaceutical targeting FAP, demostrated high stability in vitro and in vivo, and can accumulate specifically in tumors with high binding affinity, safety, and selectivity in preclinical studies. In this study, the safety, biodistribution, and radiation dosimetry of 68Ga-FAPI-JH04 in patients with different types of cancer were observed to evaluate the dosimetric characteristics of 68Ga-FAPI-JH04. ### Conditions Module **Conditions:** - Malignant Neoplasm ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Drug: 68Ga-FAPI-JH04 ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 5 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** PET imaging will begin at 3 min (30s/bed), 15min (1min/bed), 30min (2 min/bed), 60min (2 min/bed) and 150min (2 min/bed) after injection **Intervention Names:** - Drug: 68Ga-FAPI-JH04 **Label:** dynamic PET scans **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - dynamic PET scans **Description:** The dose will be 148-222 MBq given intravenously. **Name:** 68Ga-FAPI-JH04 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The safety evaluation of 68Ga-FAPI-JH04 PET/CT was performed for all patients based on the Common Toxicity Criteria for Adverse Events 5.0 (CTCAE 5.0) from baseline to follow up, including vital signs, health conditions, and laboratory tests. **Measure:** safety and tolerability **Time Frame:** Up to 1 week #### Secondary Outcomes **Description:** reported as relative uptake values per organ at 3min, 15min, 30min, 60min and 150 min per individual subject and as a mean over all subjects **Measure:** Human biodistribution **Time Frame:** From right after tracer injection to 150 min at post-injection **Description:** radiation dose to individual organs and the equivalent dose for the whole body of each subject and as a mean over all subjects. Dosimetry will be calculated using the Hybrid-Dosimetry software. **Measure:** Human dosimetry **Time Frame:** From right after tracer injection to 150 min at post-injection ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Various solid tumors with available histopathological findings * Signed informed consent Exclusion Criteria: * pregnant or lactational women * who suffered from severe hepatic and renal insufficiency **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** miaoweibing@126.com **Name:** Weibing Miao, MD **Phone:** +86-0591-87981618 **Role:** CONTACT **Contact 2:** **Email:** guochang1007@163.com **Name:** Guochang Wang, PhD **Phone:** +86-0591-87981619 **Role:** CONTACT #### Locations **Location 1:** **City:** Fuzhou **Contacts:** ***Contact 1:*** - **Email:** miaoweibing@126.com - **Name:** Weibing Miao, MD - **Phone:** +86 591 87981618 - **Role:** CONTACT ***Contact 2:*** - **Email:** guochang1007@163.com - **Name:** Guochang Wang, MD - **Phone:** +86 591 87981619 - **Role:** CONTACT **Country:** China **Facility:** Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University **State:** Fujian **Status:** RECRUITING **Zip:** 350005 #### Overall Officials **Official 1:** **Affiliation:** The First Affiliated Hospital, Fujian Medical University **Name:** Weibing Miao, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438237 **Brief Title:** Validation of a Prediction Model for Inadequate Bowel Preparation **Official Title:** Validation of a Prediction Model for Inadequate Bowel Preparation Before Colonoscopy Based on a Systematic Review and Meta-analysis #### Organization Study ID Info **ID:** V-PMIBP #### Organization **Class:** OTHER **Full Name:** General Hospital of Shenyang Military Region ### Status Module #### Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-06 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** General Hospital of Shenyang Military Region #### Responsible Party **Investigator Affiliation:** General Hospital of Shenyang Military Region **Investigator Full Name:** Xingshun Qi **Investigator Title:** Director of Gastroenterology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** We have developed a novel inadequate bowel preparation prediction model based on a systematic review and meta-analysis. The goal of this observational study is to validate the accuracy of this model. **Detailed Description:** A total of 615 patients undergoing colonoscopy will be enrolled. The primary outcome is quality of bowel preparation. The secondary outcomes include polyp/adenoma detection rate, willingness of undergoing colonoscopy again and adverse events. ### Conditions Module **Conditions:** - Bowel Preparation - Colonoscopy **Keywords:** - Bowel preparation for colonoscopy ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 615 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients were informed to eat semi-liquid and non-slag diet for breakfast and lunch and full-liquid diet for dinner on the day before colonoscopy, and be fasting on the day of colonoscopy. A split-dose 3 L PEG regimen was used for all patients. **Intervention Names:** - Procedure: Bowel preparation before colonoscopy **Label:** Patients undergoing colonoscopy ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients undergoing colonoscopy **Description:** Patients use purgative for bowel cleansing before colonoscopy. **Name:** Bowel preparation before colonoscopy **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** A total BBPS score ≥6 with BBPS score ≥2 for each colon segment was considered to have adequate bowel preparation. **Measure:** Quality of bowel preparation **Time Frame:** During the procedure of colonoscopy #### Secondary Outcomes **Description:** Proportion of patients with at least one adenoma and/or polyp detected during colonoscopy **Measure:** Adenoma and/or polyp detection rate **Time Frame:** During the procedure of colonoscopy **Description:** Number of polyps and/or adenomas detected during colonoscopy **Measure:** Number of polyps and/or adenomas **Time Frame:** During the procedure of colonoscopy **Description:** Incidence of abdominal pain, bloating, nausea/vomiting after intake of PEG. **Measure:** Adverse events **Time Frame:** Before the procedure of colonoscopy ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. adult patients (age is ≥18 years old); 2. patients undergoing colonoscopy; 3. written informed consent. Exclusion Criteria: 1. patients undergoing emergent colonoscopy; 2. patients with major psychiatric disorders; 3. pregnant or breast feeding patients; 4. patients with contraindications for colonoscopy (e.g., heart failure, renal insufficiency); 5. patients suspected to have intestinal obstruction, stenosis or perforation; 6. patients previously enrolled in this study. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adult patients undergoing colonoscopy ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** xingshunqi@126.com **Name:** Xingshun Qi **Phone:** 18909881019 **Role:** CONTACT **Contact 2:** **Email:** 373302698@qq.com **Name:** Weiyi Wang **Phone:** 13019441024 **Role:** CONTACT #### Locations **Location 1:** **City:** Shenyang **Contacts:** ***Contact 1:*** - **Email:** xingshunqi@126.com - **Name:** Xingshun Qi - **Phone:** 18909881019 - **Role:** CONTACT ***Contact 2:*** - **Email:** 373302698@qq.com - **Name:** Weiyiy Wang - **Phone:** 13019441024 - **Role:** CONTACT **Country:** China **Facility:** Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area) **State:** Liaoning **Status:** RECRUITING **Zip:** 110840 #### Overall Officials **Official 1:** **Affiliation:** Department of Gastroenterology, General Hospital of Northern Theater Command **Name:** Xingshun Qi **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10. **PMID:** 19136102 ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M27664 - Name: Laxatives - Relevance: LOW - As Found: Unknown - ID: M5651 - Name: Cathartics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438224 **Brief Title:** Clinical Utility of Extracorporeal Shock Wave Therapy in Restoring Hand Function of Patients With Nerve Injury and Hypertrophic Scars Due to Burns **Official Title:** Clinical Utility of Extracorporeal Shock Wave Therapy in Restoring Hand Function of Patients With Nerve Injury and Hypertrophic Scars Due to Burns #### Organization Study ID Info **ID:** HangangSHH-18 #### Organization **Class:** OTHER **Full Name:** Hangang Sacred Heart Hospital ### Status Module #### Completion Date **Date:** 2024-05-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05-15 **Type:** ACTUAL #### Start Date **Date:** 2023-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hangang Sacred Heart 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:** Joint contractures and nerve injuries are common after hand burns. Extracorporeal shock wave therapy (ESWT) is effective not only for the regeneration of various tissues, including scar tissues, but also for reducing pain and pruritus in patients with burns. Researchers have attempted to explore the effects of ESWT on hand dysfunction caused by nerve injury following burns. We planned to evaluate the effects of ESWT (compared to sham stimulation) on hands with nerve injury and hypertrophic scars and thereby on hand function. The ESWT parameters were as follows: energy flux density, 0.05-0.30 mJ/mm2; frequency, 4 Hz; 1000 to 2000 impulses per treatment; and 12 treatments, one/week for 12 weeks. Outcome measures were as follows: 10-point visual analog scale for pain, Jebsen-Taylor hand function test, grip strength, Purdue Pegboard test, ultrasound measurement of scar thickness, and skin characteristics before and immediately after 12 weeks of treatment. **Detailed Description:** Burns that occur in the hand cause early joint range-of-motion (ROM) limitations and hand muscle weakness that significantly affect quality of life. Hand burns, though restricted to a small total body surface area (TBSA), can have significant functional consequences. Joint contractures and nerve injuries are common after hand burns. Extracorporeal shock wave therapy (ESWT) is effective not only for the regeneration of various tissues, including scar tissues, but also for reducing pain and pruritus in patients with burns. Researchers have attempted to explore the effects of ESWT on hand dysfunction caused by nerve injury following burns. We planned to evaluate the effects of ESWT (compared to sham stimulation) on hands with nerve injury and hypertrophic scars and thereby on hand function. The ESWT parameters were as follows: energy flux density, 0.05-0.30 mJ/mm2; frequency, 4 Hz; 1000 to 2000 impulses per treatment; and 12 treatments, one/week for 12 weeks. Outcome measures were as follows: 10-point visual analog scale for pain, Jebsen-Taylor hand function test, grip strength, Purdue Pegboard test, ultrasound measurement of scar thickness, and skin characteristics before and immediately after 12 weeks of treatment. ### Conditions Module **Conditions:** - Hand Injuries - Extracorporeal Shock Wave Therapy - Burns **Keywords:** - Extracorporeal shock wave therapy - hypertrophic scar - burns - hand function - nerve injury ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen, Switzerland), with an electromagnetic cylindrical coil source used to focus the shock wave. ESWT was performed around the primary treatment site, at an intensity of 100 impulses/cm2, an energy flux density (EFD) of 0.05 to 0.30 mJ/mm2, and frequency of 4 Hz. Regarding the volume of treatment, 1000-3000 impulses were administered per session for 12 sessions held at 1-week intervals. As in previous studies, the sham group was treated using an adapter that had the same shape but did not emit any energy ##### Masking Info **Masking:** DOUBLE **Masking Description:** The outcome measurements and data analyses were performed by a trained and blinded outcome assessor who was not involved in the intervention. **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:** Those in the ESWT group were asked to select the most hypertrophic and retracting scars for treatment. ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen, Switzerland), with an electromagnetic cylindrical coil source used to focus the shock wave. ESWT was performed around the primary treatment site, at an intensity of 100 impulses/cm2, an energy flux density (EFD) of 0.05 to 0.30 mJ/mm2, and frequency of 4 Hz. Regarding the volume of treatment, 1000-3000 impulses were administered per session for 12 sessions held at 1-week intervals. **Intervention Names:** - Other: Extracorporeal shock wave therapy (ESWT) **Label:** Extracorporeal shock wave therapy (ESWT) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** the sham group was treated using an adapter that had the same shape but did not emit any energy **Intervention Names:** - Other: sham stimulation **Label:** sham group **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Extracorporeal shock wave therapy (ESWT) **Description:** Those in the ESWT group were asked to select the most hypertrophic and retracting scars for treatment. ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen, Switzerland), with an electromagnetic cylindrical coil source used to focus the shock wave. ESWT was performed around the primary treatment site, at an intensity of 100 impulses/cm2, an energy flux density (EFD) of 0.05 to 0.30 mJ/mm2, and frequency of 4 Hz. Regarding the volume of treatment, 1000-3000 impulses were administered per session for 12 sessions held at 1-week intervals. **Name:** Extracorporeal shock wave therapy (ESWT) **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - sham group **Description:** the sham group was treated using an adapter that had the same shape but did not emit any energy **Name:** sham stimulation **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** self-reported pain severity, ratings ranging from 0 (no pain) to 10 (unbearable pain **Measure:** 10-point visual analog scale (VAS) **Time Frame:** 12 weeks #### Secondary Outcomes **Description:** range of motion measurement **Measure:** the total active motion (TAM) scoring system **Time Frame:** 12 weeks **Description:** The JTT consists of seven subtests, each scored on a 0-15-point scale, with higher scores indicating better hand function **Measure:** Jebsen-Taylor hand function test (JTT) **Time Frame:** 12 weeks **Description:** quantified using a hand-held dynamometer (Lafayette Instrument, USA), with higher socres indicating more stronger **Measure:** Grip and pinch strengths **Time Frame:** 12 weeks **Description:** quantified using ultrasonography (128 BW1 US system, Medison, Korea) **Measure:** Scar thickness **Time Frame:** 12 weeks **Description:** Mexameter®(MX18, Courage-Khazaka Electronics GmbH, Germany) was used to measure the melanin levels and the severity of erythema. Higher values indicated darker and redder skin. **Measure:** erythema and pigementation **Time Frame:** 12 weeks **Description:** measured using a Tewameter® (Courage-Khazaka Electronic GmbH, Germany) to evaluate water evaporation. **Measure:** Trans-epidermal water loss (TEWL) **Time Frame:** 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ≥ 18 years old * had sustained a deep partial-thickness (second-degree) or a full-thickness (third-degree) burn in the right dominant hand, which had been treated with a split-thickness skin graft (STSG) after the thermal injury * nerve injury to the hand was confirmed by electromyography * \< 6 months prior to the enrollment Exclusion Criteria: * musculoskeletal diseases (fracture, amputation, rheumatoid arthritis, and degenerative joint diseases) of the hands * acute infection * malignant tumors * coagulopathy * pregnancy * potential for additional skin damage if exposed to ESWT and conventional occupational therapy. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** sung6652@hallym.or.kr **Name:** Sung Rakyum **Phone:** 82-2-2639-5900 **Role:** CONTACT #### Locations **Location 1:** **City:** Seoul **Contacts:** ***Contact 1:*** - **Email:** sung6652@hallym.or.kr - **Name:** Ragyem Sung - **Phone:** 82-10-5939-2541 - **Role:** CONTACT **Country:** Korea, Republic of **Facility:** Hangang sacred heart hodpital **Status:** RECRUITING **Zip:** 07247 #### Overall Officials **Official 1:** **Affiliation:** handgang sacred heart hospital **Name:** SO YOUNG JOO **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Thiele S, Thiele R, Gerdesmeyer L. Lateral epicondylitis: This is still a main indication for extracorporeal shockwave therapy. Int J Surg. 2015 Dec;24(Pt B):165-70. doi: 10.1016/j.ijsu.2015.09.034. Epub 2015 Oct 9. **PMID:** 26455532 **Citation:** Cui HS, Hong AR, Kim JB, Yu JH, Cho YS, Joo SY, Seo CH. Extracorporeal Shock Wave Therapy Alters the Expression of Fibrosis-Related Molecules in Fibroblast Derived from Human Hypertrophic Scar. Int J Mol Sci. 2018 Jan 2;19(1):124. doi: 10.3390/ijms19010124. **PMID:** 29301325 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000002921 - Term: Cicatrix - ID: D000005355 - Term: Fibrosis ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M15577 - Name: Shock - Relevance: HIGH - As Found: Shock - ID: M5326 - Name: Burns - Relevance: HIGH - As Found: Burn - ID: M10035 - Name: Hypertrophy - Relevance: HIGH - As Found: Hypertrophic - ID: M19708 - Name: Cicatrix, Hypertrophic - Relevance: HIGH - As Found: Hypertrophic Scar - ID: M9322 - Name: Hand Injuries - Relevance: HIGH - As Found: Hand Injuries - ID: M6160 - Name: Cicatrix - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: HIGH - As Found: Injury - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M8485 - Name: Fibrosis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012769 - Term: Shock - ID: D000006984 - Term: Hypertrophy - ID: D000017439 - Term: Cicatrix, Hypertrophic - ID: D000014947 - Term: Wounds and Injuries - ID: D000002056 - Term: Burns - ID: D000006230 - Term: Hand Injuries ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438211 **Brief Title:** Comparison of Postoperative Analgesic Effectiveness of Superficial and Deep Serratus Plane Blocks for Mastectomy **Official Title:** Comparison of Postoperative Analgesic Effectiveness of Superficial and Deep Serratus Plane Blocks in Patients Undergoing Mastectomy #### Organization Study ID Info **ID:** 2024/58 #### Organization **Class:** OTHER **Full Name:** TC Erciyes University ### Status Module #### Completion Date **Date:** 2025-05-25 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-02-24 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-24 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** TC Erciyes University #### Responsible Party **Investigator Affiliation:** TC Erciyes University **Investigator Full Name:** Ayse Ulgey **Investigator Title:** Professor doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Pain after breast surgery can be quite severe and can significantly affect quality of life. By successfully treating acute pain, it is aimed to prevent the formation of pain memory and to ensure that chronic pain never occurs. It is known that by using regional techniques, the use of general anesthetics and opioids can be reduced and their harmful effects can be limited. In this study, it will be compared the analgesic effectiveness of superficial and deep serratus plane blocks in the postoperative acute and chronic periods. **Detailed Description:** Acute and chronic pain is a serious problem in patients undergoing breast surgery. Apart from the feeling of pain, it also causes psychological difficulties, increased hospital stays, delays or difficulties in mobilization, and so on. Due to all these reasons, postoperative pain control is very important. Although opioids are the gold standard in the treatment of pain, their side effect profiles (sedation, respiratory depression, constipation, tolerance development, etc.) limit their use and different searches are on the agenda. There are studies showing that superficial and deep serratus plane blocks are effective in mastectomy operations. In this study, patients who underwent mastectomy these two blocks will be compared to see which one is superior and to investigate the differences that may occur in the acute and chronic periods. After general anesthesia induction, a superficial serratus plane block will be performed on the first group of patients undergoing surgery by applying local anesthetic to the fascia between the serratus anterior and latissimus dorsi muscles at the level of the 4th and 5th ribs under ultrasound. then the patient will undergo surgical procedure. Likewise, for the second group of patients, after general anesthesia induction, a deep serratus plane block will be performed by applying local anesthetic between the rib and the serratus anterior muscle at the level of the 4th and 5th ribs, under ultrasound guidance, and the patient will be taken into surgery. Both groups of patients will be monitored for 24 hours after the operation with a patient-controlled analgesia device. Patients' pain scores, satisfaction scores, nausea and vomiting scores, and additional analgesic needs will be recorded 24 hours postoperatively. ### Conditions Module **Conditions:** - Mastectomy - Postoperative Pain - Analgesia **Keywords:** - serratus anterior plane block - local anesthetic - regional anesthesia - postoperative analgesia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** OTHER #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Single-shot ultrasound (Esaote Mylab30) guided Superficial SAP block with 30 ml 0.25% bupivacain (Marcain 0.5%, Astra Zeneca, Turkey) at the T4- T5 ribs level (between the latissimus dorsi muscle and the serratus anterior muscle) was performed preoperatively to patients in the Superficial SAP group (Group I) **Intervention Names:** - Procedure: superficial or deep serratus anterior plane block for mastectomy **Label:** Group I (superficial serratus anterior plane block) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Single- shot ultrasound (Esaote Mylab30) guided Deep SAP block with 30 ml 0.25% bupivacain (Marcain 0.5%, Astra Zeneca, Turkey) at the T4- T5 ribs level ( between the serratus anterior muscle and the ribs) was performed preoperatively to patients in the Deep SAP group (Group I) **Intervention Names:** - Procedure: superficial or deep serratus anterior plane block for mastectomy **Label:** Group II (deep serratus anterior plane block) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group I (superficial serratus anterior plane block) - Group II (deep serratus anterior plane block) **Description:** group I: superficial SAP Block for postoperative analgesia for mastectomy group II: deep SAP Block for postoperative analgesia for mastectomy **Name:** superficial or deep serratus anterior plane block for mastectomy **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** How much morphine the patient consumed in the first 24 hours postoperatively with a patient-controlled anesthesia device **Measure:** postoperative morphine consumption **Time Frame:** 24 hours #### Secondary Outcomes **Description:** Determining patients' pain levels with a visual analog scale (VAS) between the scale of 1-10 **Measure:** measuring pain scors **Time Frame:** 24 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients who will undergo mastectomy surgery * patients who agreed to participate in the study * ASA I-II patients Exclusion Criteria: * Patients planned for bilateral breast surgery * Patients who have had previous breast surgery * Patients with existing neuropathic pain or receiving treatment for neuropathic pain * Patients with psychiatric disorders * Patients with opioid addiction * Patients allergic to local anesthetics **Gender Based:** True **Gender Description:** Since breast cancer is much more common in women than men and to ensure homogenization in the study, only female patients will be included. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** aulgey@erciyes.edu.tr **Name:** Ayşe Ülgey, MD **Phone:** 05378201751 **Role:** CONTACT #### Locations **Location 1:** **City:** Kayseri **Country:** Turkey **Facility:** University of Erciyes **State:** Talas **Zip:** 38100 #### Overall Officials **Official 1:** **Affiliation:** TC Erciyes University **Name:** Ayşe Ülgey, MD **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M13069 - Name: Pain, Postoperative - Relevance: HIGH - As Found: Postoperative Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010149 - Term: Pain, Postoperative ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M5315 - Name: Bupivacaine - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438198 **Acronym:** SWITCH-SAFE **Brief Title:** Early Switch From Controlled to Assisted Ventilation **Official Title:** Unraveling the (Patho)Physiological Mechanisms and Potential Clinical Benefits of an Early Switch From Controlled to Assisted Ventilation #### Organization Study ID Info **ID:** MEC-2024-0011 #### Organization **Class:** OTHER **Full Name:** Erasmus Medical Center ### Status Module #### Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-04 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Erasmus Medical Center #### Responsible Party **Investigator Affiliation:** Erasmus Medical Center **Investigator Full Name:** Annemijn Jonkman **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this physiological intervention study is to unravel the (patho)physiological mechanisms and potential clinical benefits of a pre-specified early switch from controlled to assisted ventilation in mechanically ventilated adult patients with acute hypoxemic respiratory failure (PaO2/FiO2 ratio \< 200 mmHg). The intervention is that participants will be switched from controlled to assisted ventilation when PaO2/FiO2 ratio \> 200 mmHg. The primary endpoint is the change in regional lung stress (as derived by electrical impedance tomography) when switching from controlled to assisted ventilation and until a successful or failed switch. **Detailed Description:** A crucial milestone in the trajectory of the mechanically ventilated patient is the switch from fully controlled mechanical ventilation to assisted ventilation. This switch should be made as early as feasible and safe, to limit the detrimental effects from prolonged controlled ventilation and sedation. However, there is also indirect evidence that excessive breathing effort during assisted ventilation may worsen lung injury (P-SILI). There are no guidelines that address this important switch moment. Therefore, the overall aim of this physiological intervention study is to unravel the (patho)physiological mechanisms and potential clinical benefits of a pre-specified early switch from controlled to assisted ventilation in mechanically ventilated adult patients with acute hypoxemic respiratory failure (PaO2/FiO2 ratio \< 200 mmHg). Participants will be switched from controlled to assisted ventilation switch when PaO2/FiO2 ratio \> 200 mmHg and will be monitored continuously using electrical impedance tomography, and oesophageal and gastric pressure until 4 hours post-switch and twice daily for 72 hours or until switch failure (switch back to controlled ventilation within 72 hours). The primary endpoint is the change in regional lung stress (as derived by electrical impedance tomography) when switching from controlled to assisted ventilation and until a successful or failed switch. ### Conditions Module **Conditions:** - Acute Hypoxemic Respiratory Failure - Mechanical Ventilation **Keywords:** - Electrical Impedance Tomography - Esophageal manometry - Controlled Mechanical Ventilation - Assisted Mechanical Ventilation - Respiratory Monitoring ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Switch from controlled to assisted mechanical ventilation when PaO2/FiO2-ratio \> 200 mmHg. Before switch (on controlled ventilation) participants will undergo an electrical impedance tomography (EIT) perfusion measurement as well as a photon-counting CT (PCCT) scan to assess lung perfusion and ventilation/perfusion mismatch. From 15 minutes before until 4 hours after switch and 30 minutes twice daily for 72 hours or until switch failure participants will be monitored continuously using EIT, esophageal pressure and gastric pressure. **Intervention Names:** - Other: Pre-specified switch from controlled to assisted ventilation when PaO2/FiO2-ratio > 200 mmHg **Label:** Mechanically ventilated adults **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Mechanically ventilated adults **Description:** A pre-specified switch from controlled to assisted ventilation will be initiated when PaO2/FiO2-ratio \> 200 mmHg. The moment of switch is pre-specified but patient management and ventilator settings are up to the clinical team. Switch is complete when the patient triggers all breaths spontaneously. Switch success is defined if patient reaches 72 hours on assisted ventilation. Switch failure is defined if patient switches back to controlled ventilation for more than 2 hours before 72 hours. **Name:** Pre-specified switch from controlled to assisted ventilation when PaO2/FiO2-ratio > 200 mmHg **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The change in regional lung stress as derived from EIT recordings by computing the regional ventilation distribution (ventral-to-dorsal ratio). **Measure:** Regional lung stress **Time Frame:** 72 hours #### Secondary Outcomes **Description:** Change in EIT parameters after transition from controlled to assisted ventilation (%) **Measure:** Electrical Impedance Tomography (EIT) parameters **Time Frame:** 72 hours **Description:** Ventilation/perfusion mismatch during controlled ventilation measured with photon-counting CT scan **Measure:** Photon-Counting Computed Tomography (PCCT)-derived ventilation/perfusion mismatch **Time Frame:** 30 minutes **Description:** Ventilation/perfusion mismatch during controlled ventilation measured with EIT **Measure:** Electrical Impedance Tomography (EIT)-derived ventilation/perfusion mismatch **Time Frame:** 30 minutes **Description:** Change in respiratory mechanics after transition from controlled to assisted ventilation (cmH2O) **Measure:** Respiratory mechanics **Time Frame:** 72 hours **Description:** Time-course of breathing effort during assisted ventilation as measured with esophageal manometry (cmH2O). **Measure:** Breathing effort **Time Frame:** 72 hours **Description:** Percentage of asynchronous breaths during assisted ventilation **Measure:** Patient-ventilator asynchrony **Time Frame:** 72 hours **Description:** Change in gas exchange after transition from controlled to assisted ventilation (%) **Measure:** Gas exchange **Time Frame:** 72 hours **Description:** Change in hemodynamics after transition from controlled to assisted ventilation (%) **Measure:** Hemodynamics **Time Frame:** 72 hours **Description:** Blood biomarkers concentrations including cytokines and chemokines (i.e., interleukins, TNF-alpha, MCP-1 and MIP-1beta, CD14) measured as the difference between baseline vs. 72h (%) **Measure:** Blood inflammatory biomarkers **Time Frame:** 72 hours **Description:** Swivel-derived exhaled-breath condensate biomarkers concentrations including cytokines and chemokines (i.e., interleukins, TNF-alpha, MCP-1 and MIP-1beta, CD14) measured as the difference between baseline vs. 72h (%) **Measure:** Breath condensate inflammatory biomarkers **Time Frame:** 72 hours **Description:** Ventilator-free days at day 28 **Measure:** Ventilator-free days **Time Frame:** 28 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18 years old * Written informed consent from a legal representative * Mechanical ventilation via an endotracheal tube * Acute hypoxemic respiratory failure with PaO2/FiO2 ratio \< 200 mmHg * Under continuous sedation with or without paralysis Exclusion Criteria: * Expected mechanical ventilation duration of \<48 hours * Pure chronic obstructive pulmonary disease exacerbation * Pre-existent respiratory muscle disease * Contraindication to EIT monitoring (as per clinical protocol, e.g. pacemaker, burns or thoracic wounds limiting electrode placement) * Contra-indications to oesophageal manometry (as per clinical protocol, e.g., recent oesophageal surgery, oesophageal varices, severe bleeding disorders) * Known pregnancy * Anticipating withdrawal of life support and/or shift to palliation as the goal of care **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** a.jonkman@erasmusmc.nl **Name:** Annemijn Jonkman, PhD **Phone:** +3110-7035142 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Erasmus Medical Center **Name:** Annemijn Jonkman, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012120 - Term: Respiration Disorders - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14968 - Name: Respiratory Insufficiency - Relevance: HIGH - As Found: Acute Hypoxemic Respiratory Failure - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012131 - Term: Respiratory Insufficiency ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438185 **Brief Title:** Efficacy And Safety of An IRE System For Treatment of Inferior Turbinate Hypertrophy **Official Title:** Evaluation of The Efficacy And Safety of An Irreversible Electroporation (IRE) System For Treatment of Inferior Turbinate Hypertrophy With Nasal Obstruction #### Organization Study ID Info **ID:** CLN 0157 #### Organization **Class:** INDUSTRY **Full Name:** ENTire Medical Ltd. ### Status Module #### Completion Date **Date:** 2026-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-07 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** ENTire Medical 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:** The purpose of the IRE System is to address the clinical need for reducing the volume of hypertrophic inferior turbinate(s) causing nasal obstruction while minimizing side effects and complications. Procedure time will also be reduced. The IRE System is designed to be more comfortable for patients, as it employs a noninvasive procedure using a high voltage pulsed electric field to create irreversible nanopores in the cell membrane, leading to cell death and the reduction of the inferior turbinate volume. **Detailed Description:** The purpose of the IRE System is to address the clinical need for reducing the volume of hypertrophic inferior turbinate(s) causing nasal obstruction while minimizing side effects and complications. Procedure time will also be reduced. The IRE System is designed to be more comfortable for patients, as it employs a noninvasive procedure using a high voltage pulsed electric field to create irreversible nanopores in the cell membrane, leading to cell death and the reduction of tonsil volume. On basis of these finding and in view of the known safety profile (refer to Chen et.al ) and efficacy of current technologies, the purpose of the current study is to prospectively determine the efficacy and safety of the IRE System in interior turbinate reduction. ### Conditions Module **Conditions:** - Inferior Turbinate Hypertrophy - Nasal Obstruction - Turbinate; Hypertrophy Mucous Membrane ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Irreversible Electroporation (IRE) System for Inferior Turbinate Hypertrophy with Nasal Obstruction ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The bi-polar IRE System locally applies short, high-voltage (HV) pulses, increasing the permeability of tissue cells, creating non-thermal irreversible electroporation (NTIRE). The energy is transferred via bipolar forceps and causes irreversible cell membrane perforation and apoptosis. This results in tissue reduction within 2-4 weeks after treatment. **Intervention Names:** - Device: IRE System **Label:** Enlarged Inferior Turbinate(s) will be reduced by ENTire IRE System. **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Enlarged Inferior Turbinate(s) will be reduced by ENTire IRE System. **Description:** Irreversible Electroporation (IRE) System for Inferior Turbinate Hypertrophy with Nasal Obstruction. **Name:** IRE System **Other Names:** - ENtire IRE System **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** A reduction of \> 20% in Nasal Obstruction Symptom Evaluation Scale scale and a \> 20% in the Nasal Obstruction VAS score as compared to screening visit. **Measure:** Reduction in Nasal Obstruction Symptom Evaluation Scale (NOSE) **Time Frame:** 3 months post treatment #### Secondary Outcomes **Description:** A Sinonasal Outcome Test (SNOT-22) score improvement 3 months post treatment. **Measure:** A Sinonasal Outcome Test (SNOT-22) score **Time Frame:** 3 months post treatment **Description:** Low to moderate Pain VAS (VAS/Pain VAS) score post treatment. **Measure:** Pain Visual Analog Scale (VAS) **Time Frame:** up to 1 week post treatment and through study subject completion ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 18 - 70 years. * Nasal Obstruction Symptom Evaluation (NOSE) score of ≥ 60 at the Baseline. * Hypertrophy of the inferior turbinate is the primary cause of the patient's nasal obstruction based on vasoconstriction test. * Did not improve with medical treatment, including topical nasal steroids for nasal obstruction for at least three months. Exclusion Criteria: * Age below 18 years * Patients with a pacemaker or similar electro stimulator * Patients with caudal septal deviation that narrows the anterior nasal valve. * Patients with nasal polyps/tumors. * Patients with chronic rhinosinusitis. * Patients with Eosinophilia * Patients for whom the anesthesia involves high risk. * Patients with Epilepsy or other condition involving convulsions. * Patients with an inability to give informed consent and to complete self-reported questionnaires. * Patients with an inability to cooperate for treatment and follow-up. * Patients with severe heart disease. * Pregnancy or breastfeeding. * Previous inferior turbinate surgery. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Danielle@carbo-fix.com **Name:** Danielle Vales **Phone:** +972 0508881100 **Role:** CONTACT #### Locations **Location 1:** **City:** Tel Aviv **Contacts:** ***Contact 1:*** - **Email:** Navac@tlvmc.gov.il - **Phone:** +972 03-6974444 - **Role:** CONTACT **Country:** Israel **Facility:** Tel Aviv Sourasky Medical Center **Status:** RECRUITING **Location 2:** **City:** Vilnius **Contacts:** ***Contact 1:*** - **Email:** info@santa.lt - **Phone:** +370 852365010 - **Role:** CONTACT **Country:** Lithuania **Facility:** Vilnius University Hospital Santaros Klinikos **Status:** NOT_YET_RECRUITING **Zip:** 08661 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000009668 - Term: Nose Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000000402 - Term: Airway Obstruction - ID: D000012131 - Term: Respiratory Insufficiency - ID: D000012120 - Term: Respiration Disorders - ID: D000010038 - Term: Otorhinolaryngologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases ### Condition Browse Module - Browse Leaves - ID: M10035 - Name: Hypertrophy - Relevance: HIGH - As Found: Hypertrophy - ID: M18157 - Name: Nasal Obstruction - Relevance: HIGH - As Found: Nasal Obstruction - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M12604 - Name: Nose Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M3750 - Name: Airway Obstruction - Relevance: LOW - As Found: Unknown - ID: M14968 - Name: Respiratory Insufficiency - Relevance: LOW - As Found: Unknown - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M12961 - Name: Otorhinolaryngologic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015508 - Term: Nasal Obstruction - ID: D000006984 - Term: Hypertrophy ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438172 **Acronym:** HM_APOLLO **Brief Title:** A Study to Evaluate Efficacy and Safety of HCP1803 Compared to RLD2001-1 in Patients With Essential Hypertension **Official Title:** A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate Efficacy and Safety of HCP1803 Compared to RLD2001-1 in Patients With Essential Hypertension #### Organization Study ID Info **ID:** HM-APOLLO-302 #### Organization **Class:** INDUSTRY **Full Name:** Hanmi Pharmaceutical Company Limited ### Status Module #### Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-25 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Hanmi Pharmaceutical Company Limited #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HCP1803 compared to RLD2001-1 in patients with essential hypertension ### Conditions Module **Conditions:** - Hypertension ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 220 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** HCP1803-3 **Intervention Names:** - Drug: HCP1803-3 - Drug: HPP2002-1 **Label:** Experimental **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** RLD2001-1 **Intervention Names:** - Drug: RLD2001-1 - Drug: HPP2003-3 **Label:** Active Comparator **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental **Description:** Take it once daily for 8 weeks orally. **Name:** HCP1803-3 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Active Comparator **Description:** Take it once daily for 8 weeks orally. **Name:** RLD2001-1 **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Active Comparator **Description:** Placebo drug. Take it once daily for 8 weeks orally. **Name:** HPP2003-3 **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Experimental **Description:** Placebo drug. Take it once daily for 8 weeks orally. **Name:** HPP2002-1 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Change from baseline in sitting systolic blood pressure **Time Frame:** baseline, 8 weeks #### Secondary Outcomes **Measure:** Change from baseline in sitting systolic blood pressure **Time Frame:** baseline, 4 weeks **Measure:** Change from baseline in sitting distolic blood pressure **Time Frame:** baseline, 4 weeks, 8 weeks **Measure:** Proportion of subjects achieving blood pressure control **Time Frame:** 4 weeks, 8 weeks **Measure:** Blood pressure response rate **Time Frame:** 4 weeks, 8 weeks **Measure:** Treatment response rate **Time Frame:** 4 weeks, 8 weeks **Measure:** Change from baseline in pulse pressure **Time Frame:** baseline, 4 weeks, 8 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients with essential hypertension whose blood pressure measured in visit1 corresponds to the following conditions * mean sitSBP \<180 mmHg and mean sitDBP \< 110 mmHg for patients receiving any BP-lowering drug within 1 month prior to Visit 1 * 140 mmHg ≤ mean sitSBP \< 180 mmHg and 60 mmHg ≤ mean sitDBP \< 110 mmHg for patients not receiving BP-lowering drugs within 1 month prior to Visit 1 2. Patients with essential hypertension who meet 140 mmHg ≤ mean sitSBP \< 180 mmHg and 60 mmHg ≤ mean sitDBP \< 110 mmHg at Visit 2 Exclusion Criteria: 1. Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1 2. Orthostatic hypotension with symptoms within 3 months prior to visit 1. 3. Secondary hypertensive patient or suspected to be 4. Uncontrolled diabetes mellitus(HbA1c \> 9%) or type I diabetes mellitus 5. Active gout or hyperuricemia (uric acid ≥ 9mg/dL) 6. Severe heart disease or severe neurovascular disease 7. Moderate or malignant retinopathy 8. Clinically significant hematological finding 9. Severe renal diseases (eGFR\<30mL/min/1.73m2) 10. Severe or active hepatopathy (AST or ALT ≥ 3 times of normal range) 11. Hypokalemia or Hyperkalemia(K\<3.5mmol/L or K ≥ 5.5mmol/L) 12. Hyponatremia or Hypernatremia(Na\<135mmol/L or Na ≥ 155mmol/L) 13. Hypercalcemia 14. History of malignancy tumor 15. History of autoimmune disease 16. History of alcohol or drug abuse 17. Positive to pregnancy test, nursing mother, intention on pregnancy 18. Considered by investigator as not appropriate to participate in the clinical study with other reason **Minimum Age:** 19 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** skyko7@hanmi.co.kr **Name:** Na Young Kim **Phone:** 82-2-410-9165 **Role:** CONTACT #### Locations **Location 1:** **City:** Goyang-si **Contacts:** ***Contact 1:*** - **Email:** mooyong.rhee@gmail.com - **Name:** Moo-Yong Rhee, M.D., Ph.D. - **Phone:** 82-31-961-5775 - **Role:** CONTACT **Country:** Korea, Republic of **Facility:** Donggguk University Ilsan Hospital **State:** Gyeonggi-do **Status:** RECRUITING **Zip:** 10326 #### Overall Officials **Official 1:** **Affiliation:** Donggguk University Ilsan Hospital **Name:** Moo-Yong Rhee, M.D., Ph.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### 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:** NCT06438159 **Acronym:** CARDIO-MBSR **Brief Title:** Impact of Mindfulness-Based Stress Reduction Meditation Practice on Patients After Cardiac Rehabilitation. **Official Title:** Impact of Mindfulness-Based Stress Reduction Meditation Practice on Medium- and Long-term Follow-up of Cardiac Patients After Cardiac Rehabilitation. #### Organization Study ID Info **ID:** CARDIO-MBSR #### Organization **Class:** OTHER **Full Name:** Elsan ### Status Module #### Completion Date **Date:** 2026-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Elsan #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Cardiac rehabilitation is a major component of treatment for patients suffering from coronary pathology revealed by myocardial infarction or acute coronary syndrome warranting transluminal coronary angioplasty, as well as in the aftermath of cardiac surgery. A significant proportion of patients in this situation (40%) suffer from varying degrees of anxiety and depression, which are difficult to treat. These impair their quality of life and can make it more difficult for them to take part in the rehabilitation program, compromising the results that can be expected. Finally, they are often associated with lax compliance with medical treatment, less control of risk factors and less regular exercise. Cardiac rehabilitation teams are well aware of this anxiety-depressive picture, and various therapies such as sophrology, relaxation and yoga have been proposed as alternatives to conventional medical treatments to help patients through this period. Among these alternatives is the concept of "Mindfulness-Based Meditation", based on the Mindfulness-Based Stress Reduction (MBSR) protocol described by Dr. JKabat Zinn. It has been the subject of several prospective randomized studies, which have demonstrated that it is suitable for the management of patients in this situation, and that it has measurable beneficial effects on their sense of well-being. To our knowledge, the MBSR program used in cardiac rehabilitation has never been the subject of a randomized comparative study in France to assess its effectiveness on medium- and long-term anxiety-depressive disorders. This is the objective of this study. ### Conditions Module **Conditions:** - Cardiac Disease **Keywords:** - cardiac rehabilitation - MBSR ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 74 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Conventional cardiac rehabilitation over 4 weeks with the introduction of MBSR over 8 weeks **Intervention Names:** - Other: Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR) **Label:** Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Conventional cardiac rehabilitation over 4 weeks **Intervention Names:** - Other: Conventional cardiac rehabilitation **Label:** Conventional cardiac rehabilitation **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR) **Description:** The MBSR program is as follows: * 8 weekly group sessions of 2h30 led by the mindfulness instructor, * Sessions of around 45 minutes a day to be carried out by the patient, at home, for personal training, * An intensive day between the 6th and 7th sessions to explore certain practices more intensively, in order to support participants in effectively integrating mindfulness meditation into various life situations. **Name:** Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR) **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Conventional cardiac rehabilitation **Description:** The usual cardiac rehabilitation program combines exercise training and therapeutic education workshops, with a daily session for four weeks. **Name:** Conventional cardiac rehabilitation **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** HADS (Hospital Anxiety and Depression Scale) is a self questionnaire including 14 items which identifies and quantifies the depression and anxiety from which a person suffers. **Measure:** Change from baseline of HADS anxiety and depression scores **Time Frame:** Baseline and 12 months #### Secondary Outcomes **Description:** The patients' quality of life will be measured by the MQOL-R questionnaire, which is a 14-point tool forming 4 subscales: physical, psychological, existential and social. **Measure:** To assess the quality of life **Time Frame:** Baseline, 1 month, 6 months and 12 months **Description:** The patients' compliance to their medical treatment will be measured by the GIRERD self-questionnaire including 6 questions, to assess compliance, i.e. whether treatment is taken regularly and as prescribed. **Measure:** Medical treatment compliance **Time Frame:** Baseline, 1 month, 6 months and 12 months **Description:** fasting blood glucose (in g/L) **Measure:** Changes from baseline of cardiac risk factor "fasting blood glucose" **Time Frame:** Baseline, 1 month, 6 months and 12 months **Description:** glycosylated hemoglobin (% of total hemoglobin) **Measure:** Changes from baseline of cardiac risk factor "glycosylated hemoglobin" **Time Frame:** Baseline, 1 month, 6 months and 12 months **Description:** Low Density Lipoprotein cholesterol (g/l) * Tobacco consumption (in packs.year) * BMI * Ricci Gagnon scale and 6-minute walk test **Measure:** Changes from baseline of cardiac risk factor "Lipid profile LDLc" **Time Frame:** Baseline, 1 month, 6 months and 12 months **Description:** High Density Lipoprotein cholesterol (g/l) **Measure:** Changes from baseline of cardiac risk factor "Lipid profile HDLc" **Time Frame:** Baseline, 1 month, 6 months and 12 months **Description:** BMI ( weight and height will be combined to report BMI in kg/m2) **Measure:** Changes from baseline of cardiac risk factor "BMI" **Time Frame:** Baseline, 1 month, 6 months and 12 months **Description:** 6-minute walk test **Measure:** Changes from baseline of cardiac risk factor "effort" **Time Frame:** Baseline, 1 month, 6 months and 12 months **Description:** Ricci Gagnon scale: self questionnaire including 9 questions to evaluate if the subject has an inactive, active or very active profile **Measure:** Changes from baseline of cardiac risk factor "activity" **Time Frame:** Baseline, 1 month, 6 months and 12 months **Description:** Tobacco consumption (in packs.year) **Measure:** Changes from baseline of cardiac risk factor "Tobacco consumption" **Time Frame:** Baseline, 1 month, 6 months and 12 months **Description:** Blood pressure **Measure:** Changes from baseline of cardiac risk factor "Blood pressure measurement" **Time Frame:** Baseline, 1 month, 6 months and 12 months **Description:** HADS anxiety score **Measure:** To assess the patient's anxiety **Time Frame:** Baseline, 1 months and 6 months **Description:** HADS depression score **Measure:** To assess the patient's depression **Time Frame:** Baseline, 1 months and 6 months **Description:** Patients of the MBSR group will be asked two questions : "Do you still do formal meditation practices?" "Do you still do informal meditation practices?" **Measure:** To evaluate the continuation of formal and informal mindfulness meditation practices in patients who have benefited from the MBSR program. **Time Frame:** 3 months, 6 months and 12 months **Description:** FFMQ (Five Facets Mindfulness Questionnaire) questionnaire, which includes 39 questions, which assess the 5 facets which constitute mindfulness as a construct: * Describe the experience: talk about the experience in words. * Acting mindfully: performing actions with active attention to each step. * Non-judgment: absence of positive or negative comments on the thoughts and emotions experienced. * Non-reactivity to private events: allowing thoughts and emotions to exist without responding to them automatically. * Observation: remaining aware and focused on the experience, even when it is aversive or painful. **Measure:** To evaluate the patient's "mindfulness" and its impact on vital aspects in patients who have benefited from the MBSR program. **Time Frame:** 3 months, 6 months and 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Cardiac patients eligible for cardiac rehabilitation, 2. Patient with a Hospital Anxiety and Depression Scale (HADS) score for the anxiety dimension (HADS-A) \>7 or a score for the depression dimension (HADS-D) \> 7 3. Age ≥ 18 years 4. Affiliated with a social security scheme or beneficiary of such a scheme 5. Patient signed free and informed consent form Exclusion Criteria: 1. Patients already treated for severe psychiatric disorders (major depression, psychosis, schizophrenia) 2. Inability to follow the 8-week MBSR program 3. Protected patient: minor, adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision 4. Medical conditions which may interfere with the conduct of the study and the investigator's judgment, and which may render the patient unfit to participate in the study. 5. Pregnant or breast-feeding patient 6. Refusal to participate in the study or inability to comply with the study protocol for any reason whatsoever **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** cardiotmkb@me.com **Name:** Bernard Truong, MD **Phone:** +33622079508 **Role:** CONTACT **Contact 2:** **Name:** Bernard Truong, MD **Role:** CONTACT #### Locations **Location 1:** **City:** Aressy **Contacts:** ***Contact 1:*** - **Email:** cardiotmk@me.com - **Name:** Bernard Truong, MD - **Phone:** +33622079508 - **Role:** CONTACT ***Contact 2:*** - **Name:** Bernard Truong, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** Clinique d'Aressy **Zip:** 64320 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M9419 - Name: Heart Diseases - Relevance: HIGH - As Found: Cardiac Disease ### Condition Browse Module - Meshes - ID: D000006331 - Term: Heart Diseases ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438146 **Acronym:** LIROH **Brief Title:** LIROH - Liraglutide for Obesity in HIV **Official Title:** Liraglutide for Management of Obesity in People Living With HIV on Dolutegravir-based Antiretroviral Therapy: a Single-arm Acceptability Study in South Africa #### Organization Study ID Info **ID:** 2023P002985 #### Organization **Class:** OTHER **Full Name:** Brigham and Women's Hospital #### Secondary ID Infos **ID:** K23DK125162 **Link:** https://reporter.nih.gov/quickSearch/K23DK125162 **Type:** NIH ### Status Module #### Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-02 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-05-02 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) #### Lead Sponsor **Class:** OTHER **Name:** Brigham and Women's Hospital #### Responsible Party **Investigator Affiliation:** Brigham and Women's Hospital **Investigator Full Name:** Jennifer M. Manne-Goehler, MD, SCD **Investigator Title:** Assistant Professor of Medicine **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 goal of this single-arm, open label pilot study is to evaluate liraglutide at the recommended dosage administered subcutaneously + lifestyle counselling for the management of people living with HIV (PLWH) with obesity defined by a BMI ≥30 kg/m2 who are on dolutegravir-based ART. Following individual informed consent, all participants will undergo a series of basic cardiometabolic labs. They will then be initiated on liraglutide 0.6 mg administered subcutaneously, and this dose will be gradually increased over a period of 4 weeks to a dose of 3.0 mg daily. Alongside drug administration, participants will receive lifestyle counselling regarding diet and physical activity. Following completion of a 12-week "on treatment" period, liraglutide will be stopped and participants will be followed for an additional 12-weeks off treatment. Body weight, cardiometabolic risk parameters, and a suite of patient-reported outcomes regarding diet, physical activity, sleep, and quality of life will be assessed periodically over the course of the study. **Detailed Description:** South Africa has the largest population of PLWH globally, with a prevalence of 17% in adults or 7.2 million PLWH. The rapid scale-up of ART programs has resulted in \>6 million PLWH on treatment, significant gains in life expectancy, and a large population of aging PLWH. With increasing life expectancy, obesity and type 2 diabetes have become growing threats for PLWH in South Africa and globally. One recent study found that 63% of PLWH are overweight or obese, and 6% have diabetes in this setting. This elevated risk of obesity in PLWH in South Africa is likely due to a confluence of both general considerations and HIV-specific factors. First, South Africa has experienced an accelerated background epidemic of metabolic disease in the general population with a prevalence of overweight and obesity that is nearly equal to that of high-income countries. Additionally, the International Diabetes Federation estimates that approximately 15.5 million adults are living with diabetes in the African Region, and projects it to grow to 41 million by 2045. As part of this background epidemic of metabolic disease, South Africa is also experiencing a nutrition transition, with widespread availability of processed and refined foods as well as sugar-sweetened beverages. Regarding HIV-specific issues, in 2019 the first-line ART regimen for the South African national HIV treatment program transitioned to TLD. TLD is generally very safe and well-tolerated and has a high barrier to HIV resistance but this transition to this regimen has been associated with risk of excess weight gain at the population level. Both clinical trials and observational studies conducted in South Africa have shown substantial increases in body weight in those who are initiating this ART regimen newly and among those who are suppressed and switched, especially women. Given this, there is a growing risk of obesity in PLWH in this context and a need for management strategies to address this increasingly prevalent comorbidity. Preventing the metabolic complications of HIV in South Africa and worldwide requires urgent solutions. To date, obesity management and diabetes prevention have largely consisted of behavioural interventions such as the Diabetes Prevention Program and related lifestyle modification efforts, focused on improving diet and increasing physical activity. However, in the past several years, novel anti-obesity pharmacologic agents such as the glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have shown enormous promise for obesity management and diabetes prevention in people who are HIV-negative (8-10). However, this drug class has a very limited evidence base in PLWH and relatively scant data from sub-Saharan African populations. Currently, liraglutide is the only GLP-1 RA approved for obesity management in South Africa and this protocol proposes to use the drug for its labelled indication of "weight loss in addition to diet and exercise in adults aged 18 and above who have: (1) a BMI of 30 or greater (obese) or (2) a BMI of greater than 27 and less than 30 (overweight) and weight related health problems (such as diabetes, high blood pressure, hypercholesterolemia, or obstructive sleep apnoea). This evidence gap motivates further inquiry into GLP-1 RAs such as liraglutide as one potential approach to obesity management and prevention of diabetes in PLWH who have comorbid obesity in South Africa, with implications for PLWH in other contexts. In this proposal, the investigators seek to further this important area of inquiry by evaluating the acceptability of liraglutide along with lifestyle counselling in PLWH who have obesity and are stable on dolutegravir-based ART in South Africa. ### Conditions Module **Conditions:** - Obesity - HIV Infections **Keywords:** - HIV - Obesity - Liraglutide - Behavior - Exercise - Lifestyle counseling ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Following individual informed consent, all participants will undergo a series of basic cardiometabolic labs. They will then be initiated on liraglutide 0.6 mg administered subcutaneously, and this dose will be gradually increased over a period of 4 weeks to a dose of 3.0mg daily. Alongside drug administration, participants will receive lifestyle counselling regarding diet and physical activity. Following completion of a 12-week "on treatment" period, liraglutide will be stopped and participants will be followed for an additional 12-weeks off treatment. Body weight, cardiometabolic risk parameters, and a suite of patient-reported outcomes regarding diet, physical activity, sleep, and quality of life will be assessed periodically over the course of the study. **Intervention Names:** - Drug: Liraglutide **Label:** Lirgalutide **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Lirgalutide **Description:** Dosing regimen: In this study protocol, liraglutide dosing will be implemented as follows: Liraglutide will be started at a dose of 0.6 mg per day. Participants will be taught to use the injection pen and will be observed giving the first injection. The dose will then be increased by 0.6 mg each week to a maximum dosage of 3.0 mg per day at the end of 4 weeks. This corresponds to the following dosing schedule: Week 1: 0.6 mg per day for one week Week 2: 1.2 mg per day for one week Week 3: 1.8 mg per day for one week Week 4: 2.4 mg per day for one week Week 5-12: 3.0 mg per day for 8 weeks Week 13-24: No drug administration **Name:** Liraglutide **Other Names:** - Saxenda **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Systolic blood pressure change in mm Hg **Measure:** Change in blood pressure following 12 weeks on treatment **Time Frame:** Measured at Visit 4 at 12 weeks **Description:** Blood pressure change in mm Hg **Measure:** Change in blood pressure over 24 weeks (12 weeks on + 12 weeks off treatment) **Time Frame:** Measured at End of Study at 24 weeks **Description:** Change in total cholesterol **Measure:** Change in lipids following 12 weeks on treatment **Time Frame:** Measured at Visit 4 at 12 weeks **Description:** Change in total cholesterol **Measure:** Change in lipids over 24 weeks (12 weeks on + 12 weeks off treatment) **Time Frame:** Measured at End of Study at 24 weeks **Description:** Change in waist circumference in cm **Measure:** Change in waist circumference following 12 weeks on treatment **Time Frame:** Measured at Visit 4 at 12 weeks **Description:** Change in waist circumference in cm **Measure:** Change in waist circumference over 24 weeks (12 weeks on + 12 weeks off treatment) **Time Frame:** Measured at End of Study at 24 weeks **Description:** Change in quality of life scale score (scale of 0 - 100) **Measure:** Change in quality of life following 12 weeks on treatment per the World Health Organization's Quality of Life Instrument in HIV Infection **Time Frame:** Measured at Visit 4 at 12 weeks **Description:** Change in quality of life scale score (scale of 0 - 100) **Measure:** Change in quality of life over 24 weeks (12 weeks on + 12 weeks off treatment) per the World Health Organization's Quality of Life Instrument in HIV Infection **Time Frame:** Measured at End of Study at 24 weeks **Description:** Change in sleep quality scale score (global score range of 0 to 21 where score of 5 or greater indicates poor sleep) **Measure:** Change in sleep quality following 12 weeks on treatment per the Pittsburgh Sleep Quality Index **Time Frame:** Measured at Visit 4 at 12 weeks **Description:** Change in sleep quality scale score (global score range of 0 to 21 where score of 5 or greater indicates poor sleep) **Measure:** Change in sleep quality over 24 weeks (12 weeks on + 12 weeks off treatment) per the Pittsburgh Sleep Quality Index **Time Frame:** Measured at End of Study at 24 weeks #### Primary Outcomes **Description:** This will be expressed in terms of the proportion of participants who attend screening and enrolment visits among the total number who are approached regarding interest in study participation. **Measure:** Proportion of participants who screen and enroll among those approached **Time Frame:** Measured at screening **Measure:** Time to reach study enrollment target **Time Frame:** Measured at enrollment **Description:** This will be expressed as a proportion of participants who remain in the study after the 12 week "on treatment" period among those enrolled. **Measure:** Study retention rate at 12 weeks **Time Frame:** Measured at Visit 4 at 12 weeks **Description:** This will be expressed as a proportion of participants who remain in the study after the full 24 weeks of study procedures are completed among those enrolled. **Measure:** Study retention rate at 24 weeks **Time Frame:** Measured at End of Study at 24 weeks **Description:** The investigators will assess volume remaining in the injector pens and provide a percentage of doses per participant that remained unused at the end of the 12-week period on treatment. **Measure:** Rate of adherence to treatment over 12 weeks **Time Frame:** Measured at Visit 4 at 12 weeks **Description:** This will be open-ended responses to a brief exit interview about acceptability and feasibility. **Measure:** Embedded qualitative interviews regarding the acceptability of liraglutide for obesity management **Time Frame:** Measured at End of Study at 24 weeks #### Secondary Outcomes **Description:** The investigators will report incidence of TEAEs up to 24 weeks (12 weeks on + 12 weeks off treatment) **Measure:** Incidence of treatment-emergent adverse events as defined in this protocol **Time Frame:** From the initiation of treatment until the date of a treatment-emergent adverse event, assessed up to 24 weeks. **Description:** The investigators will report incidence of SAEs up to 24 weeks (12 weeks on + 12 weeks off treatment) **Measure:** Incidence of serious adverse events (SAEs), as defined in this protocol **Time Frame:** From the initiation of treatment until the date of a serious adverse event, assessed up to 24 weeks. **Description:** Body weight will be measured in the study at both enrolment and after 12 weeks on treatment (Visit 4); these will be used to calculate a continuous change in kg. **Measure:** Change in body weight following 12 weeks on treatment **Time Frame:** Measured at Visit 4 at 12 weeks **Description:** Body weight will be measured in the study at both enrolment and after 24 weeks on treatment (EOS); these will be used to calculate a continuous change in kg. **Measure:** Change in body weight over 24 weeks (12 weeks on + 12 weeks off treatment) **Time Frame:** Measured at End of Study at 24 weeks **Description:** HbA1c will be measured at enrolment and at Visit 4; here investigators will calculate the difference between these measures (in %). **Measure:** Change in HbA1c following 12 weeks on treatment **Time Frame:** Measured at Visit 4 at 12 weeks **Description:** HbA1c will be measured at enrolment and at EOS; here investigators will calculate the difference between these measures (in %). **Measure:** Change in HbA1c over 24 weeks (12 weeks on + 12 weeks off treatment) **Time Frame:** Measured at End of Study at 24 weeks **Description:** Fasting glucose will be measured at enrolment and at Visit 4; investigators will calculate the difference between these measures (in mmol/L). **Measure:** Change in fasting plasma glucose following 12 weeks on treatment **Time Frame:** Measured at Visit 4 at 12 weeks **Description:** Fasting glucose will be measured at enrolment and at EOS; investigators will calculate the difference between these measures (in mmol/L). **Measure:** Change in fasting plasma glucose over 24 weeks (12 weeks on + 12 weeks off treatment) **Time Frame:** Measured at End of Study at 24 weeks **Description:** This will be defined as the difference in depression score per the Patient Health Questionnaire (PHQ-9) at enrolment and Visit 4. The minimum value is 1 and the maximum is 27, where the greater the total score, the greater severity of depression. **Measure:** Change in depressive symptoms following 12 weeks on treatment **Time Frame:** Measured at Visit 4 at 12 weeks **Description:** This will be defined as the difference in depression score per the Patient Health Questionnaire (PHQ-9) at enrolment and EOS. The minimum value is 1 and the maximum is 27, where the greater the total score, the greater severity of depression. **Measure:** Change in depressive symptoms over 24 weeks (12 weeks on + 12 weeks off treatment) **Time Frame:** Measured at End of Study at 24 weeks **Description:** This will be defined as the difference in physical activity expressed in MET-minutes per week, where MET minutes represent the amount of energy expended carrying out physical activity, per the International Physical Activity Questionnaire (IPAQ) at enrolment and Visit 4. **Measure:** Change in physical activity level following 12 weeks on treatment **Time Frame:** Measured at Visit 4 at 12 weeks **Description:** This will be defined as the difference in physical activity expressed in MET-minutes, where MET minutes represent the amount of energy expended carrying out physical activity, per week per the International Physical Activity Questionnaire (IPAQ) at enrolment and EOS. **Measure:** Change in physical activity level over 24 weeks (12 weeks on + 12 weeks off treatment) **Time Frame:** Measured at End of Study at 24 weeks **Description:** This will be defined as the difference in total servings of fruits and vegetables, change in frequency of sugar-sweetened beverage intake, and change frequency of fast food intake from enrolment to Visit 4. **Measure:** Change in dietary habits following 12 weeks on treatment **Time Frame:** Measured at Visit 4 at 12 weeks **Description:** This will be defined as the difference in total servings of fruits and vegetables, change in frequency of sugar-sweetened beverage intake, and change frequency of fast food intake from enrolment to EOS. **Measure:** Change in dietary habits over 24 weeks (12 weeks on + 12 weeks off treatment) **Time Frame:** Measured at End of Study at 24 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Able to give written informed consent to participate in the study 2. Able to comply with all study procedures, including daily subcutaneous injections 3. Adults ≥18 years old 4. PLWH on dolutegravir-based ART for ≥6 months 5. Documented HIV-1 viral load in the past 6 months confirming the participant is virologically suppressed 6. BMI ≥30 kg/m2 7. Desiring weight loss 8. Willing to undertake lifestyle change 9. Not on any weight loss agent for the duration of the study Exclusion Criteria: 1. Self-reported history of diabetes 2. Current use of medications for diabetes 3. Known contraindications to liraglutide, such as hypersensitivity to a component of the drug 4. Current pregnancy or desire to become pregnant 5. History of pancreatitis 6. History of thyroid disease 7. History of harmful use of alcohol 8. Clinically unstable in the opinion of the investigator **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jmanne@bwh.harvard.edu **Name:** Jennifer Manne-Goehler, MD, ScD **Phone:** 7542246060 **Role:** CONTACT #### Locations **Location 1:** **City:** Mtubatuba **Contacts:** ***Contact 1:*** - **Email:** ngundu.behuhuma@ahri.org - **Name:** Ngundu Behuhuma, MBChB - **Phone:** 082 964 0652 - **Role:** CONTACT ***Contact 2:*** - **Name:** Ngundu Behuhuma, MBChB - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Mark Siedner, MD, MPH - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Limakatso Lebina, MBChB - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 5:*** - **Name:** Jennifer Manne-Goehler, MD, ScD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** South Africa **Facility:** Africa Health Research Institute Clinical Trials Unit **Status:** RECRUITING **Zip:** 3935 #### Overall Officials **Official 1:** **Affiliation:** Brigham and Women's Hospital **Name:** Jennifer Manne-Goehler, MD, ScD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Access to the IPD and the associated documents will require completion of the online data access application form accessible on the AHRI Data repository. AHRI bona fide data users are required to abide by the data use conditions stipulated on the application for access to the data. **Description:** Anonymized data as allowable **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES **Time Frame:** The IPD data will be shared in accordance with AHRI Data Access Policy and Data Management Plan within two years of completion. **URL:** https://data.ahri.org/ ### References Module #### References **Citation:** Venter WDF, Moorhouse M, Sokhela S, Fairlie L, Mashabane N, Masenya M, Serenata C, Akpomiemie G, Qavi A, Chandiwana N, Norris S, Chersich M, Clayden P, Abrams E, Arulappan N, Vos A, McCann K, Simmons B, Hill A. Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV. N Engl J Med. 2019 Aug 29;381(9):803-815. doi: 10.1056/NEJMoa1902824. Epub 2019 Jul 24. **PMID:** 31339677 **Citation:** Venter WDF, Sokhela S, Simmons B, Moorhouse M, Fairlie L, Mashabane N, Serenata C, Akpomiemie G, Masenya M, Qavi A, Chandiwana N, McCann K, Norris S, Chersich M, Maartens G, Lalla-Edward S, Vos A, Clayden P, Abrams E, Arulappan N, Hill A. Dolutegravir with emtricitabine and tenofovir alafenamide or tenofovir disoproxil fumarate versus efavirenz, emtricitabine, and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection (ADVANCE): week 96 results from a randomised, phase 3, non-inferiority trial. Lancet HIV. 2020 Oct;7(10):e666-e676. doi: 10.1016/S2352-3018(20)30241-1. **PMID:** 33010240 **Citation:** Manne-Goehler J, Rahim N, van Empel E, de Vlieg R, Chamberlin G, Ihama A, Castle A, Mabweazara S, Venter WDF, Chandiwana N, Levitt NS, Siedner M. Perceptions of Health, Body Size, and Nutritional Risk Factors for Obesity in People with HIV in South Africa. AIDS Behav. 2024 Jan;28(1):367-375. doi: 10.1007/s10461-023-04152-7. Epub 2023 Aug 26. **PMID:** 37632604 **Citation:** Chandiwana NC, Siedner MJ, Marconi VC, Hill A, Ali MK, Batterham RL, Venter WDF. Weight Gain After HIV Therapy Initiation: Pathophysiology and Implications. J Clin Endocrinol Metab. 2024 Jan 18;109(2):e478-e487. doi: 10.1210/clinem/dgad411. **PMID:** 37437159 **Citation:** Magodoro IM, Olivier S, Gareta D, Koole O, Modise TH, Gunda R, Herbst K, Pillay D, Wong EB, Siedner MJ. Linkage to HIV care and hypertension and diabetes control in rural South Africa: Results from the population-based Vukuzazi Study. PLOS Glob Public Health. 2022 Nov 2;2(11):e0001221. doi: 10.1371/journal.pgph.0001221. eCollection 2022. **PMID:** 36962629 **Citation:** Rubino DM, Greenway FL, Khalid U, O'Neil PM, Rosenstock J, Sorrig R, Wadden TA, Wizert A, Garvey WT; STEP 8 Investigators. Effect of Weekly Subcutaneous Semaglutide vs Daily Liraglutide on Body Weight in Adults With Overweight or Obesity Without Diabetes: The STEP 8 Randomized Clinical Trial. JAMA. 2022 Jan 11;327(2):138-150. doi: 10.1001/jama.2021.23619. **PMID:** 35015037 **Citation:** Wadden TA, Bailey TS, Billings LK, Davies M, Frias JP, Koroleva A, Lingvay I, O'Neil PM, Rubino DM, Skovgaard D, Wallenstein SOR, Garvey WT; STEP 3 Investigators. Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity: The STEP 3 Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1403-1413. doi: 10.1001/jama.2021.1831. **PMID:** 33625476 **Citation:** Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10. **PMID:** 33567185 **Citation:** Hyle EP, Bekker LG, Martey EB, Huang M, Xu A, Parker RA, Walensky RP, Middelkoop K. Cardiovascular risk factors among ART-experienced people with HIV in South Africa. J Int AIDS Soc. 2019 Apr;22(4):e25274. doi: 10.1002/jia2.25274. **PMID:** 30990252 **Citation:** Bailin SS, Gabriel CL, Wanjalla CN, Koethe JR. Obesity and Weight Gain in Persons with HIV. Curr HIV/AIDS Rep. 2020 Apr;17(2):138-150. doi: 10.1007/s11904-020-00483-5. **PMID:** 32072466 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000050177 - Term: Overweight - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: HIGH - As Found: Obesity - 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: M3522 - Name: Acquired Immunodeficiency Syndrome - Relevance: LOW - As Found: Unknown - ID: M26186 - Name: Overweight - Relevance: LOW - As Found: Unknown - ID: M25307 - Name: Overnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009765 - Term: Obesity ### Intervention Browse Module - Ancestors - ID: D000097789 - Term: Glucagon-Like Peptide-1 Receptor Agonists - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000054795 - Term: Incretins - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M419 - Name: Liraglutide - Relevance: HIGH - As Found: Due - ID: M347662 - Name: Dolutegravir - Relevance: LOW - As Found: Unknown - ID: M25428 - Name: Anti-Retroviral Agents - Relevance: LOW - As Found: Unknown - ID: M9043 - Name: Glucagon - Relevance: LOW - As Found: Unknown - ID: M3401 - Name: Glucagon-Like Peptide-1 Receptor Agonists - Relevance: LOW - As Found: Unknown - ID: M26997 - Name: Glucagon-Like Peptide 1 - Relevance: LOW - As Found: Unknown - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown - ID: M27905 - Name: Incretins - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000069450 - Term: Liraglutide ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438133 **Acronym:** CIMON **Brief Title:** Digital Supported Compression Bandaging in Patients With Chronic Edema in the Lower Limbs **Official Title:** Digital Supported Compression Bandaging in Patients With Chronic Edema in the Lower Limbs - Assessment of Measurement Properties of a Novel Sensor #### Organization Study ID Info **ID:** CIMON #### Organization **Class:** OTHER **Full Name:** Herlev and Gentofte Hospital ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-03 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Rigshospitalet, Denmark **Class:** OTHER **Name:** Hvidovre University Hospital **Class:** OTHER **Name:** Bispebjerg Hospital **Class:** OTHER **Name:** Odense University Hospital #### Lead Sponsor **Class:** OTHER **Name:** Carsten Bogh Juhl #### Responsible Party **Investigator Affiliation:** Herlev and Gentofte Hospital **Investigator Full Name:** Carsten Bogh Juhl **Investigator Title:** Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Patients with chronic edema of the lower limb referred to compression bandaging in a hospital setting will be invited to participate in the validation study of a novel sensor (CIMON), which have been developed for assessing the effect of compression bandaging. Participants will have the sensor applied to the lower limb before initiation of compression bandaging and will receive usual compression treatment according to severity of the edema and usual practice at the treatment site. Duration of participation is 14 days. **Detailed Description:** The CIMON sensor is developed with the purpose of monitoring the effectiveness of compression bandaging (CB) in patients with chronic edema by application to the widest circumference of the calf. CIMON measures the difference in capacitance by stretching the circumferential sensor. Data from the sensor is transferred by Bluetooth technology to a secured webserver, where healthcare professionals can monitor the effect of compression bandaging. The study aims to assess the psychometric properties of the CIMON (reliability, validity and responsiveness) and assess the correlation between edema reduction and physical activity during compression bandaging. ### Conditions Module **Conditions:** - Compression; Vein - Venous Insufficiency - Lymphedema of Leg - Digital Technology **Keywords:** - Compression therapy - Compression bandaging - Chronic edema - Psychometrics ### 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 with chronic edema of the lower limbs referred to compression bandaging in a hospital setting. **Intervention Names:** - Other: CIMON - Other: Sens Motion **Label:** Patients with chronic edema of the lower limbs ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients with chronic edema of the lower limbs **Description:** The sensor assess changes in the circumference of the limb and will be applied to the lower limb before compression bandaging is applied. **Name:** CIMON **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Patients with chronic edema of the lower limbs **Description:** The sensor assess physical activity and the amount of time spent at rest, standing, walking, running and count steps. **Name:** Sens Motion **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Assessed by Cimon sensor (in capacitans, pF) **Measure:** Edema reduction **Time Frame:** 14 days #### Secondary Outcomes **Description:** Assessed by tape measurement (in cm), converted to volume by formula of truncated cone **Measure:** Edema reduction **Time Frame:** 14 days **Description:** Assessed by perometry (in ml) **Measure:** Edema reduction **Time Frame:** 14 days **Description:** Assessed by Dual energy X-ray Absorptiometry (in kg) **Measure:** Edema reduction **Time Frame:** 14 days **Description:** Self-reported pain, tension and heaviness **Measure:** Symptoms related to chronic edema **Time Frame:** 14 days **Description:** Assessed by Sens Motion sensor (PA by sedentary time, low+moderate and high intensity in minutes) **Measure:** Physical Activity (PA) **Time Frame:** 14 days **Description:** Any adverse events related to compression bandaging and the application of sensors **Measure:** Adverse events **Time Frame:** 14 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Chronic edema of the lower limb * Referred to compression bandaging * Circumference of widest point of the lower leg between 35-75 cm Exclusion Criteria: * Wounds at the lower leg (at the widest circumference of the lower leg) * Acute deep venous thrombosis in the leg * Untreated cellulitis * Severe heart- or kidneyfailure * Severe peripheral neuropathy in the lower limbs **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with chronic edema of the lower limbs referred to compression bandaging in a hospital setting. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** merete.celano.wittenkamp@regionh.dk **Name:** Merete Celano Wittenkamp, MPH **Phone:** +93911784 **Role:** CONTACT **Contact 2:** **Email:** carsten.bogh.juhl@regionh.dk **Name:** Carsten Bogh Juhl, Professor **Role:** CONTACT #### Locations **Location 1:** **City:** Bispebjerg **Contacts:** ***Contact 1:*** - **Name:** Mette L Joergensen, RN - **Role:** CONTACT **Country:** Denmark **Facility:** Department of Dermatology, Frederiksberg Bispebjerg Hospital **State:** Capital Region **Location 2:** **City:** Copenhagen **Contacts:** ***Contact 1:*** - **Name:** Jan Christensen, Phd - **Role:** CONTACT **Country:** Denmark **Facility:** Department of Physiotherapy and Occupational Therapy, Rigshospitalet **State:** Capital Region **Zip:** 2100 **Location 3:** **City:** Herlev **Contacts:** ***Contact 1:*** - **Email:** merete.celano.wittenkamp@regionh.dk - **Name:** Merete C Wittenkamp, MPH - **Phone:** +4593911784 - **Role:** CONTACT **Country:** Denmark **Facility:** Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital **State:** Capital Region **Zip:** 2730 **Location 4:** **City:** Hvidovre **Contacts:** ***Contact 1:*** - **Name:** Kira Marie Milandt Skibdal, Msc - **Role:** CONTACT **Country:** Denmark **Facility:** Department of Physiotherapy and Occupational Therapy, Amager Hvidovre Hospital **State:** Capital Region **Location 5:** **City:** Odense **Contacts:** ***Contact 1:*** - **Name:** Marianne Holt, Msc - **Role:** CONTACT **Country:** Denmark **Facility:** Department of Oncology, Unit of Lymphedema care, Odense University Hospital **State:** Region Of Southern Denmark #### Overall Officials **Official 1:** **Affiliation:** Herlev and Gentofte Hospital **Name:** Carsten Bogh Juhl, Professor **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008206 - Term: Lymphatic Diseases - 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 - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M7657 - Name: Edema - Relevance: LOW - As Found: Unknown - ID: M17435 - Name: Venous Insufficiency - Relevance: HIGH - As Found: Venous Insufficiency - ID: M11206 - Name: Lymphedema - Relevance: HIGH - As Found: Lymphedema - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014689 - Term: Venous Insufficiency - ID: D000008209 - Term: Lymphedema ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438120 **Brief Title:** Chatbot-based Positive Psychology Intervention in Caregivers of Children With Autism Spectrum Disorder **Official Title:** Chatbot-based Positive Psychology Intervention to Promote Well-being in Caregivers of Children With Autism Spectrum Disorder: A Pilot Feasibility Study #### Organization Study ID Info **ID:** RD/2023/1.20 #### Organization **Class:** OTHER **Full Name:** Hong Kong Metropolitan University ### Status Module #### Completion Date **Date:** 2025-07-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-05 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-04 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hong Kong Metropolitan University #### Responsible Party **Investigator Affiliation:** Hong Kong Metropolitan University **Investigator Full Name:** Dr Wendy Zhang Wen **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This project aims to evaluate the feasibility and preliminary effectiveness of chatbot-based positive psychology intervention. **Detailed Description:** According to a World Health Organization report, one in 100 children is diagnosed with Autism Spectrum Disorder (ASD), which is characterized by varying degrees of disability and deviation in social communication and interaction. Half of the parents of children with ASD have reported showing depression and high levels of anxiety. Lower well-being and poor quality-of-life have also been reported. Thus, there is an urgent need to find applicable interventions to reduce depressive symptoms and promote mental health in caregivers of children with ASD. Positive psychology intervention uses positive psychological skills, such as savoring, gratitude, forgiveness, optimism, personal strength, and attainable goals, to identify meaning and value in life events and to promote positive emotions, cognitions and behaviors. Considering the convenience, low cost and popularity of chatbot, chatbot-based positive psychology intervention will be applied in this study. A pilot feasibility study will be proposed to evaluate the feasibility of chatbot-based positive psychology intervention. The primary objective is to evaluate the feasibility and preliminary effectiveness of chatbot-based positive psychology intervention in promoting well-being in caregivers of children with ASD (Primary). The secondary objectives are: To test if the intervention reduces perceived stress in caregivers of children with ASD; To test if the intervention reduces depressive symptoms of caregivers of children with ASD; To test if the intervention improves quality of life in caregivers of children with ASD. ### Conditions Module **Conditions:** - Autism Spectrum Disorder ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Participants will receive chatbot-based positive psychology exercises including positive introduction, personal strengths, using strengths, three good things, gratitude letter/visit, hope and optimism, active/constructive responding, and savoring. ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In this group, participants will receive chatbot-based positive psychology intervention. **Intervention Names:** - Behavioral: Chatbot-based positive psychology intervention **Label:** Chatbot group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Chatbot group **Description:** Eight positive psychology exercises will be delivered, including positive introduction, personal strengths, using strengths, three good things, gratitude, hope and optimism, active/constructive responding, and savoring. **Name:** Chatbot-based positive psychology intervention **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Feasibility will be assessed by 2 items modified from the Feasibility of Intervention Measure, and the semi-structured interview will be conducted immediately after the intervention (9-week follow-up). Barriers and facilitators to participant adherence and retention will be discussed to collect feedback. These 2 items will ask participants to evaluate that the Chatbot is implementable and easy to use via a 5-point Likert scale from completely disagree (1) to completely agree (5). The score range is 2 to 10 and higher scores indicate greater feasibility. **Measure:** The score of feasibility **Time Frame:** Baseline and after the intervention immediately (8-week follow-up) **Description:** The focus group will be conducted to learn about the barriers and facilitators to participant adherence, and retention will be discussed to collect feedback. The perspectives on potential feasibility, acceptability, facilitators, barriers, priority domains, and suggestions for the Chatbot will be discussed. **Measure:** Qualitative results of feasibility **Time Frame:** Baseline and after the intervention immediately (8-week follow-up) **Description:** Well-being will be measured by the World Health Organization-5 Well-being Index to evaluate vitality (being active and waking up fresh and rested), being interested in things, and having a pleasant attitude. Each item is scored using a 6-point Likert scale from at no time (0) to all of the time (5). The total score ranges from 0 to 25, with higher scores suggesting better self-perceived well-being. **Measure:** The score of well-being **Time Frame:** Baseline and after the intervention immediately (8-week follow-up) #### Secondary Outcomes **Description:** Perceived Stress will be assessed by a 10-item Perceived Stress Scale (PSS-10) with a 5-point Likert scale from never (0) to very often (4). The total score is from 0 to 40 and a higher score reflects a higher level of perceived stress. **Measure:** Perceived Stress **Time Frame:** Baseline and after the intervention immediately (8-week follow-up) **Description:** Depressive symptoms will be measured by the Patient Health Questionnaire-9 (PHQ-9), which evaluates the frequency of occurrence of main depressive symptoms over the past 2 weeks via a 4-point Likert scale from not at all (0) to nearly every day (3). The total score is from 0 to 27 and the higher scores indicate more severe depressive symptoms. **Measure:** Depressive symptoms **Time Frame:** Baseline and after the intervention immediately (8-week follow-up) **Description:** Quality of life will be measured by the Chinese version of Short Form-8(SF-8), including 8 sub-scales: general health perception, physical function, bodily pain, role limitations due to physical health problems, vitality, role limitations due to emotional problems, social function, and mental health. A norm-based scoring method will be applied to calculate physical summary scores and mental summary scores. The sub-scale score can be represented as T-scores(mean =50, standard deviation =10) and a higher score indicating better QoL. **Measure:** The score of Quality of life **Time Frame:** Baseline and after the intervention immediately (8-week follow-up) ### Eligibility Module **Eligibility Criteria:** Inclusion criteria: Primary caregivers * (i) providing long-term care for the primary-school-age child (6-11 years old) diagnosed with ASD; * (ii) who are over 18 years old; * (iii) who have the ability to communicate and read in Chinese; * (iv) who have at least one mobile phone with an internet connection. Exclusion criteria: Primary caregivers * (i) who participate in a similar psychological intervention within one year; * (ii) currently on regular psychotropic medications. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** wwzhang@hkmu.edu.hk **Name:** Wen Zhang, PhD **Phone:** +852-3970-2945 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000065886 - Term: Neurodevelopmental Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4623 - Name: Autistic Disorder - Relevance: HIGH - As Found: Autism - ID: M206 - Name: Autism Spectrum Disorder - Relevance: HIGH - As Found: Autism Spectrum Disorder - ID: M5903 - Name: Child Development Disorders, Pervasive - Relevance: HIGH - As Found: Autism Spectrum Disorder - ID: M5902 - Name: Developmental Disabilities - Relevance: LOW - As Found: Unknown - ID: M30644 - Name: Neurodevelopmental Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001321 - Term: Autistic Disorder - ID: D000067877 - Term: Autism Spectrum Disorder - ID: D000002659 - Term: Child Development Disorders, Pervasive ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438107 **Brief Title:** Deep Phenotyping of the Renal Allograft to Prognosticate Clinical Outcomes **Official Title:** Deep Phenotyping of the Renal Allograft to Prognosticate Clinical Outcomes #### Organization Study ID Info **ID:** STUDY21090074 #### Organization **Class:** OTHER **Full Name:** University of Pittsburgh ### Status Module #### Completion Date **Date:** 2029-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-26 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-02-19 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Pittsburgh #### Responsible Party **Investigator Affiliation:** University of Pittsburgh **Investigator Full Name:** Aravind Cherukuri **Investigator Title:** Assistant Professor of Medicine and Surgery **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this observational study is to determine phenotypic, transcriptional, and epigenetic underpinnings of renal allograft rejection in renal transplant rejection. The main questions it aims to answer are: * To determine the phenotype, frequency, location, and the inter-cellular interactions between the cells that constitute intra-graft inflammatory infiltrate in acute ejection. * To determine the phenotype, frequency, location, and the inter-cellular interactions between the cells that constitute intra-graft inflammatory infiltrate in recurrent/recalcitrant rejection vs. rejection that resolves with therapy. * To generate a scRNA sequencing (scRNAseq) map of the intra-graft immune cells and the renal parenchymal cells and compare the transcriptional and epigenetic changes within these cells in recurrent/recalcitrant rejection vs. rejection that resolves with therapy. * To determine phenotypic changes associated with chronic rejection. Participants will be asked to provide the following research specimens: * Renal biopsy specimens at the following timepoints: day of transplantation (pre-implantation and post-perfusion); routine protocol biopsies at 3 months and 12 months; and clinically indicated for-cause biopsies at any timepoint from time-0 to 1-yr post-transplantation. The 1st research core will be used for routine histopathological examination and left over tissue from this core will be used for deep phenotyping using multiparameter immunophenotyping, and digital spatial profiling. The second research core will be used for extraction of cells and nuclei for scRNAseq and snATACseq. * Blood samples will be processed to obtain plasma (for cytokine, chemokine and DSA measurements) and PBMC (for deep phenotyping and molecular analyses). For each collection timepoint, up to 75 mL (about 5 tablespoons) will be collected. * Prospective clinical data and outcomes will be collected from participant medical records. * Follow-Up Period: For-cause biopsies from 1-yr to 5-yr post-transplantation (by the transplant nephrologist): no additional cores will be obtained for research from these biopsies. The left-over tissue from the clinically indicated biopsy cores will be analyzed by deep phenotyping and digital spatial profiling. Blood samples will be processed to obtain plasma (for cytokine, chemokine and DSA measurements) and PBMC (for deep phenotyping and molecular analyses). **Detailed Description:** This study is exploratory in nature and aims to elucidate the phenotypic, transcriptional, and epigenetic underpinnings of renal transplant rejection. The study is designed to provide improved understanding of the regulation of intra-graft alloimmune response in the renal transplant recipients. In this single center, prospective, longitudinal, observational cohort study, sequential assessment of renal biopsies will be performed at baseline (pre-implantation), 3 months and at one-year post-transplantation in addition to any for-cause biopsies within the first five years post-transplantation. Blood samples will be also collected at the time of renal biopsies for comparison analyses. HYPOTHESIS It is proposed that unique phenotypic, transcriptional, and epigenetic changes within the parenchymal and the infiltrating nonparenchymal inflammatory cells dictate the evolution of renal allograft inflammation and rejection. The following research specimens will be obtained from each study participant: 1. The day of transplantation (by the UPMC operating surgeon): Pre-implantation core renal biopsy and post-perfusion core renal biopsy: Two research cores for each biopsy will be taken from the transplanted kidney. The pre-implantation biopsy specimens are obtained on the back table, and the post-perfusion cores are taken prior to closure of the surgical incision. The 1st research core will be used for routine histopathological examination and left over tissue from this core will be used for deep phenotyping using multiparameter immunophenotyping, and digital spatial profiling. The second research core will be used for extraction of cells and nuclei for scRNAseq and snATACseq. Blood samples will be processed to obtain plasma (for cytokine, chemokine and DSA measurements) and PBMC (for deep phenotyping and molecular analyses). For each collection timepoint, up to 75 mL (about 5 tablespoons) will be collected. 2. Protocol biopsies at 3 months and 12 months (by the transplant nephrologist): Renal transplant recipients at UPMC routinely undergo clinical post-transplant biopsies at 3 months and at 12 months. An additional research core will be collected along with the clinically indicated biopsy cores at both these time points (3 total passes of the biopsy needle for each collection). Left over tissue from the clinically indicated core will be used for deep phenotyping using multiparameter immunophenotyping, and digital spatial profiling. The research core will be used for extraction of cells and nuclei for scRNAseq and snATACseq. Blood samples will be processed to obtain plasma (for cytokine, chemokine and DSA measurements) and PBMC (for deep phenotyping and molecular analyses). 3. For-cause biopsies from time-0 to 1-yr post-transplantation (by the transplant nephrologist): Along with the protocol biopsies, UPMC renal transplant patients also undergo biopsies for clinical indication (for-cause biopsies). Again, an additional research core will be collected along with the clinically indicated biopsy cores whenever a patient undergoes any for-cause biopsy between time-0 and 1-year post-transplantation (3 total passes of the biopsy needle for each collection). Left over tissue from the clinically indicated core will be used for deep phenotyping using multiparameter immunophenotyping, and digital spatial profiling. The research core will be used for extraction of cells and nuclei for scRNAseq and snATACseq. Blood samples will be processed to obtain plasma (for cytokine, chemokine and DSA measurements) and PBMC (for deep phenotyping and molecular analyses). The investigators will review procedures associated with the consent with participants again at the time of each of these biopsies to confirm their continued interest in participation. As these procedures are a part of the standard of care biopsies that the patients undergo, no additional hospital visits are expected. The research specimens will be delivered to and processed by laboratory research members. Prospective clinical data and outcomes will be collected from participant medical records. The following clinical data will be collected from each research participant: 1. Demographic characteristics (e.g., age, gender, ethnicity, cause of renal disease) 2. Pre-transplant clinical variables (e.g., h/o prior transplant, HLA mismatches, panel reactive antibodies, prior use of immunosuppression, cold ischemia time, warm ischemia time) 3. De-identified donor data (e.g., donor age, gender, ethnicity, donor type, KDPI) as available at time of transplant 4. Immunosuppression details (e.g., induction and maintenance agents, trough CNI levels through the 1st post-transplant year) 5. Clinical outcomes (e.g., DGF; detection of DSA; biopsy clinical reports; Serum Creatinine and eGFR at 1, 3, 6, and 12 months, and then at 2, 3, 4, and 5 years; graft and patient survival at 5 years) Follow-Up Period For-cause biopsies from 1-yr to 5-yr post-transplantation (by the transplant nephrologist): These are the standard-of-care indication biopsies that are performed beyond the 1st post-transplant year, up to 5 years post-transplantation. While no additional cores will be obtained for research from these biopsies (about 2 passes of the biopsy needle per standard practices), we will analyze the left-over tissue from the clinically indicated biopsy cores by deep phenotyping (Marcus Clark Lab, University of Chicago; MTA in place) and digital spatial profiling (Randhawa Lab, University of Pittsburgh). Blood samples will be processed to obtain plasma (for cytokine, chemokine and DSA measurements) and PBMC (for deep phenotyping and molecular analyses). STUDY AIMS Aim 1. To determine phenotypic, transcriptional, and epigenetic underpinnings of renal allograft rejection. 1. A) To determine the phenotype, frequency, location, and the inter-cellular interactions between the cells that constitute intra-graft inflammatory infiltrate in acute ejection. (1B) To generate a scRNA sequencing (scRNAseq) map of the intra-graft immune cells and the renal parenchymal cells and determine the transcriptional and epigenetic changes within these cells at baseline, prior to the diagnosis, and at the diagnosis of acute rejection. Analysis of these changes longitudinally through the 1st post-transplant year will allow us to delineate the natural history of renal allograft rejection. Aim 2. To determine phenotypic, transcriptional, and epigenetic differences that underlie persistence vs. resolution of acute rejection after renal transplantation. 2. A) To determine the phenotype, frequency, location, and the inter-cellular interactions between the cells that constitute intra-graft inflammatory infiltrate in recurrent/recalcitrant rejection vs. rejection that resolves with therapy. (2B) To generate a scRNA sequencing (scRNAseq) map of the intra-graft immune cells and the renal parenchymal cells and compare the transcriptional and epigenetic changes within these cells in recurrent/recalcitrant rejection vs. rejection that resolves with therapy. Aim 3. To determine phenotypic changes associated with chronic rejection. In a subset of patient in whom for-cause transplant biopsies are available past the 1st year and up to 5 years after transplantation, we will perform multi-parameter immunophenotyping and spatial transcriptional analysis to explore cellular infiltrate and transcriptional changes associated with chronic rejection. Exploratory Endpoints: 1. To correlate the frequency and phenotype of the intra-graft inflammatory infiltrate with histological diagnosis within the 1st post-transplant year (acute rejection vs. borderline rejection vs. no acute rejection). 2. To determine the transcriptional and epigenetic changes within intra-graft immune cells and graft parenchymal cells at baseline, prior to and at the diagnosis of acute rejection or borderline rejection in comparison to no rejection. 3. To determine phenotypic, transcriptional, and epigenetic differences that underlie persistence vs. resolution of acute rejection in the 1st post-transplant year. 4. To determine the phenotypic and transcriptional changes associated with chronic rejection. 5. To correlate histological phenotypes with peripheral blood phenotypes. ### Conditions Module **Conditions:** - Renal Transplant Rejection **Keywords:** - Organ rejection - Acute rejection ### Design Module #### Bio Spec **Description:** Renal biopsy core tissue specimens, blood plasma and PBMC samples **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 24 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Living donor and deceased donor renal transplant recipients. There is no intervention to be administered. **Label:** Renal transplantation recipients ### Outcomes Module #### Primary Outcomes **Description:** Percentage biopsy proven acute rejection either on a surveillance biopsy or a for-cause biopsy in the First Post-Transplant Year **Measure:** Percentage of Participants with Biopsy Proven Acute Rejection at one year **Time Frame:** 1 year **Description:** Degree of Correlation of Transcriptional Changes Within the Infiltrating Inflammatory Cells Assessed by scRNA Sequencing in the First Post-Transplant Year **Measure:** Degree of Correlation of Acute Rejection Transcriptional Changes Within the Infiltrating Inflammatory Cells at one year **Time Frame:** 1 year **Description:** Percentage Correlation of Acute Rejection Transcriptional Changes Within the Renal Parenchymal Cells Assessed by scRNA Sequencing in the First Post-Transplant Year **Measure:** Percentage of Correlation of Transcriptional Changes Within the Renal Parenchymal Cells at one year **Time Frame:** 1 year #### Secondary Outcomes **Description:** Percentage Histological Persistence of Rejection in the First Post-Transplant Year **Measure:** Percentage of Histological Persistence of Rejection at one year **Time Frame:** 1 year **Description:** Degree of Correlation of Histological Transcriptional Changes Within the Infiltrating Inflammatory Cells in the First Post-Transplant Year **Measure:** Degree of Correlation of Histological Transcriptional Changes Within the Infiltrating Inflammatory Cells at one year **Time Frame:** 1 Year **Description:** Degree of Correlation of Histological Transcriptional Changes Within the Renal Parenchymal Cells in the First Post-Transplant Year **Measure:** Degree of Correlation of Histological Transcriptional Changes Within the Renal Parenchymal Cells at one year **Time Frame:** 1 Year **Description:** Percentage biopsy proven acute rejection either on a surveillance biopsy or a for-cause biopsy in the Third Post-Transplant Year **Measure:** Percentage of Participants with Biopsy Proven Acute Rejection at Year 3 **Time Frame:** 3 Years **Description:** Degree Correlation of Transcriptional Changes Within the Infiltrating Inflammatory Cells Assessed by scRNA Sequencing in the Third Post-Transplant Year **Measure:** Degree of Correlation of Acute Rejection Transcriptional Changes Within the Infiltrating Inflammatory Cells at Year 3 **Time Frame:** 3 Years **Description:** Degree of Correlation of Acute Rejection Transcriptional Changes Within the Renal Parenchymal Cells Assessed by scRNA Sequencing in the Third Post-Transplant Year **Measure:** Degree of Correlation of Transcriptional Changes Within the Renal Parenchymal Cells at Year 3 **Time Frame:** 3 Years **Description:** Degree of Correlation of Transcriptional Changes Within the Infiltrating Inflammatory Cells of Allograft Biopsy as Assessed by Digital Spatial Transcriptomic Analysis in the Third Post-Transplant Year **Measure:** Degree of Correlation of Acute Rejection Transcriptional Changes Within the Infiltrating Inflammatory Cells at year 3 **Time Frame:** 3 Years **Description:** Degree of Correlation of Transcriptional Changes Within the Renal Parenchymal Cells with Persistence or Resolution of Allograft Inflammation as Assessed by Digital Spatial Transcriptomic Analysis in the Third Post-Transplant Year **Measure:** Degree of Correlation of Acute Rejection Transcriptional Changes Within the Renal Parenchymal Cells **Time Frame:** 3 Years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. All adult living or deceased donor renal transplant recipients (age ≥ 18 years), irrespective of gender, race, or ethnic background. 2. Able to understand and provide inform consent. Exclusion Criteria: 1. Medical contraindications to undergo renal biopsy (use of long-term anticoagulation, low platelet count of \<100,000/uL) 2. Cause of ESRD likely to recur in transplant: Hemolytic uremic syndrome (HUS) 3. Not maintained on standard of care immunosuppression therapy (Thymoglobulin induction followed by tacrolimus and mycophenolate maintenance) **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adult living donor or deceased donor renal transplant recipients ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** elinbd@upmc.edu **Name:** Beth Elinoff, RN **Phone:** 412-624-6611 **Role:** CONTACT **Contact 2:** **Email:** cherukuria@upmc.edu **Name:** Aravind Cherukuri, MD **Phone:** 4125250671 **Role:** CONTACT #### Locations **Location 1:** **City:** Pittsburgh **Contacts:** ***Contact 1:*** - **Email:** elinbd@upmc.edu - **Name:** Beth Elinoff, RN - **Phone:** 412-624-6611 - **Role:** CONTACT **Country:** United States **Facility:** UPMC **State:** Pennsylvania **Zip:** 15213 #### Overall Officials **Official 1:** **Affiliation:** University of Pittsburgh **Name:** Aravind Cherukuri, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Subject research data/samples may be shared with investigators conducting other research; this information will be shared without identifiable information. Subjects will not be identified in any publication or in the sharing of data about this study. These samples and data will be under the control of the listed investigators. Researchers must present a scientifically valid written request to the PI of this study, who will then either approve or deny the request. **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 ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438094 **Brief Title:** The Influence of Non-Carious Cervical Lesions on Root Coverage **Official Title:** The Influence of Non-Carious Cervical Lesions on Root Coverage by Means of Coronally Advanced Flap and a Connective Tissue Graft: A Prospective Cohort Study #### Organization Study ID Info **ID:** PER-ECL-2022-01 #### Organization **Class:** OTHER **Full Name:** Universitat Internacional de Catalunya ### Status Module #### Completion Date **Date:** 2026-05-25 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-02 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-05-25 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-26 **Type:** ACTUAL **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-05-26 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Gonzalo Blasi #### Responsible Party **Investigator Affiliation:** Universitat Internacional de Catalunya **Investigator Full Name:** Gonzalo Blasi **Investigator Title:** Clinical professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this prospective cohort study is to evaluate the effect of non-carious cervical lesions (NCCLs) on the outcome of root coverage therapy. The main question it aims to answer is: In gingival recessions associated with NCCLs, characterized by an undetectable cemento-enamel junction (CEJ), reconstruction of the CEJ with a cervical composite restoration, prior to root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft (CAF+CTG), provides similar clinical and patient-reported outcomes, as compared to the treatment of gingival recessions associated with NCCLs, characterized by a visible CEJ, with root coverage surgery only, by means of a CAF+CTG. In NCCLs where the CEJ is undetectable (B-type defect), the CEJ will be reconstructed before surgery with a cervical composite restoration mimicking the anatomic features of the contralateral, homologous tooth. CAF+CTG treatment will be performed in all cases. Participants will be assessed at 6 weeks, 3 months, and 6 months to evaluate clinical, volumetric, and patient-centred outcomes. **Detailed Description:** In this investigation, a prospective cohort study, several key outcomes will be assessed. First, we seek to determine whether restoring the cementoenamel junction (CEJ) in Class B GRs before root coverage therapy yields comparable clinical and volumetric outcomes to Class A GRs with detectable CEJ. In addition, the influence of the CEJ restoration on dentin sensitivity and aesthetic satisfaction of the patient will be investigated. To our knowledge, it will be the first clinical study to use Pini Prato et al.'s surface discrepancy classification as a decision-making tool to guide periodontal-restorative procedures. ### Conditions Module **Conditions:** - Gingival Recession ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** There are two treatments but they are based on the tooth-level ##### Masking Info **Masking:** DOUBLE **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 56 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Gingival recession defects that present with a visible CEJ. These defects will receive root coverage surgery only. **Intervention Names:** - Procedure: Root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft **Label:** Type A gingival recession defects **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Gingival recession defects that do not present a visible CEJ. A cervical composite restoration will be done prior to root coverage surgery. **Intervention Names:** - Procedure: Reconstruction of the CEJ with a composite restoration followed by root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft **Label:** Type B gingival recession defects **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Type A gingival recession defects **Description:** A root coverage surgery will be performed using Zucchelli et al.'s coronally advanced flap combined with a connective tissue graft from the palate. **Name:** Root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Type B gingival recession defects **Description:** Reconstruction of the CEJ with a composite restoration will be performed in B+ and B- defects prior to root coverage surgery. A root coverage surgery will be performed using Zucchelli et al.'s coronally advanced flap combined with a connective tissue graft from the palate. **Name:** Reconstruction of the CEJ with a composite restoration followed by root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Mean root coverage assessed in percentage **Measure:** Mean Root Coverage (MRC) **Time Frame:** 6 months #### Secondary Outcomes **Description:** Complete Root Coverage assessed in percentage **Measure:** Complete Root Coverage (CRC) **Time Frame:** 6 months **Description:** Change in keratinized tissue width assessed digitally in mm **Measure:** Change in keratinized tissue width (ΔKTW) **Time Frame:** 6 weeks, 3 months, 6 months **Description:** Change in marginal gingival thickness assessed at 1, 2, and 3 mm from the gingival margin in mm **Measure:** Change in marginal gingival thickness (ΔMGT) **Time Frame:** 6 weeks, 3 months, 6 months **Description:** Change in recession depth assessed digitally in mm **Measure:** Change in recession depth (ΔRD) **Time Frame:** 6 weeks, 3 months, 6 months **Description:** change in recession area assessed digitally in mm\^2 **Measure:** Change in recession area (ΔRA) **Time Frame:** 6 weeks, 3 months, 6 months **Description:** change in mucosal volume assessed digitally in mm\^3 **Measure:** Change in mucosal volume (ΔMV) **Time Frame:** 6 weeks, 3 months, 6 months **Description:** probing pocket depth assessed clinically in mm using a periodontal probe **Measure:** Probing pocket depth (PPD) **Time Frame:** 6 months **Description:** Clinical attachment level assessed clinically in mm (sum of probing pocket depth and recession) **Measure:** Clinical attachment level (CAL) **Time Frame:** 6 months **Description:** Dentin sensitivity assessed on each tooth after directing an air blast from a triple syringe at the buccal cervical areas, maintaining a distance of 1 cm for 5 seconds, using a Visual Analog Scale \[0-100\] **Measure:** Dentin sensitivity as assessed by VAS (Visual Analog Scale) **Time Frame:** Initial, 6 months **Description:** Patient aesthetic satisfaction assessed using a Visual Analog Scale \[0-100\] **Measure:** Patient aesthetic satisfaction as assessed by VAS (Visual Analog Scale) **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Systemically healthy individuals older than 18 years old; * Healthy periodontal status according to the AAP/EFP definition; * Full-mouth plaque (FMPS) and bleeding scores (FMBS) ≤ 20%; * At least one facial RT1 GR in single-rooted teeth with a minimum depth of 2 mm, associated with a NCCL; * No history of periodontal surgery at the experimental site(s). Exclusion Criteria: * Pregnancy or lactation; * Self-reported smoking ≥10 cigarettes/day; * Metabolic diseases that negatively affect soft tissue healing (i.e., diabetes mellitus); * Any medication that may interfere with wound healing; * Prosthetic crown at experimental teeth; * Ongoing orthodontic therapy. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** gonzaloblasi@uic.es **Name:** Gonzalo Blasi **Phone:** 620387688 **Role:** CONTACT **Contact 2:** **Email:** lory.abrahamian@uic.es **Name:** Lory Abrahamian **Phone:** 722528012 **Role:** CONTACT #### Locations **Location 1:** **City:** Barcelona **Contacts:** ***Contact 1:*** - **Email:** gonzaloblasi@uic.es - **Name:** Gonzalo Blasi - **Phone:** 620387688 - **Role:** CONTACT **Country:** Spain **Facility:** BLASI Clínica Dental Barcelona **Status:** RECRUITING **Zip:** 08021 #### Overall Officials **Official 1:** **Affiliation:** Universitat Internacional de Catalunya **Name:** Gonzalo Blasi **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Universitat Internacional de Catalunya **Name:** José Nart **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005882 - Term: Gingival Diseases - ID: D000010510 - Term: Periodontal Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000055093 - Term: Periodontal Atrophy ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M9001 - Name: Gingival Recession - Relevance: HIGH - As Found: Gingival Recession - ID: M8994 - Name: Gingival Diseases - Relevance: LOW - As Found: Unknown - ID: M13419 - Name: Periodontal Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M4589 - Name: Atrophy - Relevance: LOW - As Found: Unknown - ID: M28025 - Name: Periodontal Atrophy - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005889 - Term: Gingival Recession ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06438081 **Brief Title:** Comparison Between Propess and Cook Double-balloon Catheter for Cervical Priming: a Randomized Controlled Trial **Official Title:** Comparison Between Propess (Dinoprostone Controlled Release Pessary) and Cook Double-balloon Catheter for Cervical Priming: a Randomized Controlled Trial #### Organization Study ID Info **ID:** UW 24-172 #### Organization **Class:** OTHER **Full Name:** The University of Hong Kong ### Status Module #### Completion Date **Date:** 2025-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-26 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Study First Submit Date:** 2024-05-26 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The University of Hong Kong #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** True **Is US Export:** True ### Description Module **Brief Summary:** We aimed to compare efficacy and safety of Propess versus Cooks double-balloon catheter for cervical ripening with an unfavorable cervix in term pregnancy. **Detailed Description:** Previous studies focused on use of PGE2 instead of Propess, which is a preparation of PGE2 packaged in a hydrogel polymer matrix and release 10mg dinoprostone at 0.3mg per hour for 24 hours. Compared with PGE2, Propess can achieve a shorter induction-to-birth interval, a higher rate of vaginal delivery within 24 hours, and a smaller number of vaginal examinations during delivery. However local studies comparing the efficacy and satisfaction of cervical priming between Cook double-balloon catheter and Propess were lacking. We aimed to compare efficacy and safety of Propess versus Cooks double-balloon catheter for cervical ripening with an unfavorable cervix in term pregnancy. ### Conditions Module **Conditions:** - Delivery Problem ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** We did a pilot study to compare 5 patients using Cook double-catheter balloon priming and 5 patients using Propess. We found the mean priming to delivery interval was 1971.6 minutes in Propess group and 1212.0 minutes in Cook double-catheter balloon group. We assumed ratio of sample size in Propess and Cook double-catheter balloon was 1:1. In order to achieve 35% reduction of priming to delivery interval, a sample size of 28 is required for Type I error of 0.05, and Type II error of 0.2. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 28 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participant is placed in lithotomy position, then to clean vulval and vaginal area, followed by inserting vaginal speculum. Cook double-balloon catheter will be inserted under standard technique. Doctor or midwife guide the cervical ripening balloon with stylet to pass through the cervix. Uterine balloon should be place above level of internal os, then to remove the stylet before further advancing the catheter. Cook double-balloon catheter is further advancing through the cervix until both balloons entered cervical canal. Uterine and vaginal balloons are both inflated with up to 80ml normal saline according to manufacturer recommendation. Maximal duration of balloon placement will be 12 hours. If cervix remains unfavorable after Cook double-catheter balloons, she will be given another Cook double-catheter balloons priming the next day. If cervix remains unfavourable after two balloon priming, elective Caesarean section will be advised. **Intervention Names:** - Combination Product: Cook double-balloon catheter **Label:** Cook double-balloon catheter **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Participant will be firstly confirmed reactive tracing and without regular contraction by non-stress test for 20mins. Propess will be checked its integrity and applied with lubricating jelly before insertion. Propess is inserted to the posterior vaginal fornix. Woman should inform medical staff if they have leaking sensation. After insertion, woman will be advised to lie down and perform non-stress test for 2 hours. Propess will be removed after 24 hours post insertion. Cervical assessment is performed the next day after removal of Propess. Patient with favourable cervix, i.e. Bishop score \>= 7, will start artificial rupture of membrane and syntocinon infusion. Patient with unfavorable cervix, i.e. Bishop score \<7 is arranged another day of priming by PGE2. If the cervix remains unfavorable after 2 days of pharmacological priming, women will be given a rest day or continued priming by Cook double-balloon catheter. **Intervention Names:** - Combination Product: Cook double-balloon catheter **Label:** Propess **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Cook double-balloon catheter - Propess **Description:** To compare whether Cook double-balloon catheter or Propess able to achieve vaginal delivery with a shorter priming to delivery interval **Name:** Cook double-balloon catheter **Type:** COMBINATION_PRODUCT ### Outcomes Module #### Primary Outcomes **Description:** Time for priming (device placement) to delivery interval **Measure:** Priming to delivery interval **Time Frame:** 1 year #### Secondary Outcomes **Description:** delivery within 24 hours **Measure:** Vaginal delivery within 24 hours after priming **Time Frame:** 1 year **Description:** need of resort to Caesarean section and the corresponding indication **Measure:** Caesarean section rate **Time Frame:** 1 year **Description:** included instrumental delivery, e.g. vacuum extraction, forcep delivery **Measure:** Vaginal delivery rate **Time Frame:** 1 year **Description:** Time from priming to induction **Measure:** Priming to induction interval **Time Frame:** 1 year **Description:** Chance of going into spontaneous labor after priming **Measure:** Need of induction with oxytocin **Time Frame:** 1 year **Description:** calculate the amount of oxytocin use **Measure:** Amount of oxytocin use **Time Frame:** 1 year **Description:** to confirm if cephalic presentation before start of induction **Measure:** Malpresentation after priming **Time Frame:** 1 year **Description:** defined as cervix failed to dilate to more than 3cm after 12 hours use of oxytocin **Measure:** Failed induction rate **Time Frame:** 1 year **Description:** defined by a single contraction lasting for more than 2 minutes or more than 5 contractions in 10 minutes for 30 minutes **Measure:** Uterine hyperstimulation **Time Frame:** 1 year **Description:** infection rate that require antibiotics treatment **Measure:** Suspected intrauterine infection rate **Time Frame:** 1 year **Description:** Blood loss \>500ml within 24 hours of delivery **Measure:** Primary postpartum haemorrhage **Time Frame:** 1 year **Description:** calculate length of hospital stay after delivery **Measure:** Length of hospital stay **Time Frame:** 1 year **Description:** on a visual analogue scale of 0-10, 10 is most satisfactory **Measure:** Maternal satisfaction with the procedure **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Viable singleton pregnancy * Cephalic presentation * Bishop score \<7 * At term (\>=37+0 weeks of gestation) * Nulliparous women Exclusion Criteria: * Gestation \<37weeks * Multiple pregnancy * Bishop score \<7 * Malpresentation * Contraindication to vaginal delivery * Previous Caesarean section * History of myomectomy * Maternal fever * Suspected infection * Abnormal fetal heart-rate patterns * Rupture of membranes * Intrauterine growth restriction * Not fit for giving consent * Allergic to Propess or PGE2 **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** lyf971@hku.hk **Name:** Yin Fong Leung, MBBS **Phone:** 852 22554517 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** The University of Hong Kong **Name:** Yin Fong Leung, MBBS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007744 - Term: Obstetric Labor Complications - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7594 - Name: Dystocia - Relevance: HIGH - As Found: Delivery Problem - ID: M10764 - Name: Obstetric Labor Complications - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004420 - Term: Dystocia ### Intervention Browse Module - Browse Branches - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M13041 - Name: Oxytocin - Relevance: LOW - As Found: Unknown - ID: M17936 - Name: Dinoprostone - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False