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## Protocol Section ### Identification Module **NCT ID:** NCT06423742 **Brief Title:** Consecutive Dual-Session tDCS in Chronic Subjective Severe to Catastrophic Tinnitus With Normal Hearing **Official Title:** Consecutive Dual-Session tDCS in Chronic Subjective Severe to Catastrophic Tinnitus With Normal Hearing #### Organization Study ID Info **ID:** 2021-11-009 #### Organization **Class:** OTHER **Full Name:** Dongtan Sacred Heart Hospital ### Status Module #### Completion Date **Date:** 2022-09-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-09-30 **Type:** ACTUAL #### Start Date **Date:** 2021-12-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Dongtan Sacred Heart Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** We aimed to analyze the effect of continuous dual session tDCS in patients with severe chronic subjective tinnitus without any evidence of hearing loss in terms of relief of tinnitus perception, distress, and loudness. Also, we investigated the difference in the maintenance duration of the tinnitus suppression effect of consecutive dual session tDCS compared to other groups followed up for 2 months. **Detailed Description:** The participants were randomly allocated with three different arms (control, single-session, and dual session) using block to balance the size of each group. Pure tone audiometry, speech audiometry, tinnitogram (pitch matching, loudness, minimal masking level and residual inhibition), auditory evoked potential, THI, visual analogue scale (VAS) of loudness, awareness and annoyance, and BDI were evaluated as a baseline tests. Participants who assigned to the control group underwent dual sham stimulation per day, twice a week for 1 month. Patients were received sham and true stimulation once alternately in the single session group and two true stimulation per day in the dual session group for the same period as the control group. All subjects who enrolled this study were given a conventional treatment such as tinnitus retraining therapy, sound therapy using sound generator, and medications like clonazepam, selective serotonin reuptake inhibitors for patients who wanted to take for relief of symptoms. ### Conditions Module **Conditions:** - Tinnitus, Subjective **Keywords:** - Transcranial direct current stimulation - Tinnitus ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The participants were randomly allocated with three different arms (control, single-session, and dual session) using block to balance the size of each group. . Participants who assigned to the control group underwent dual sham stimulation per day, twice a week for 1 month. Patients were received sham and true stimulation once alternately in the single session group and two true stimulation per day in the dual session group for the same period as the control group. All subjects who enrolled this study were given a conventional treatment such as tinnitus retraining therapy, sound therapy using sound generator, and medications like clonazepam, selective serotonin reuptake inhibitors for patients who wanted to take for relief of symptoms. ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 42 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The subjects in control group were received two consecutive sessions of sham stimulation twice a week for 4 weeks (8 sessions in total). **Intervention Names:** - Device: Transcranial direct current stimulation **Label:** control **Type:** SHAM_COMPARATOR #### Arm Group 2 **Description:** Patients enrolled to the single-session group received tDCS on one random session out of two consecutive sessions. **Intervention Names:** - Device: Transcranial direct current stimulation **Label:** single-session **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** In the dual-session group, the patients underwent two consecutives tDCS. **Intervention Names:** - Device: Transcranial direct current stimulation **Label:** dual-session **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - control - dual-session - single-session **Description:** The device used for tDCS in this study was DC-Stimulator Plus (NeuroConn GmbH, Ilmenau, Germany). The localization of stimulation area (DLPFC) was determined according to the 10/20 EEG system. Non-conducting, elastic head strap was placed around the head to prevent displacement during stimulation. The recording electrode covered with 5 x 7 cm sized traditional rectangular sponge was soaked with 6-7 mL of 0.9% NaCl saline solution per side and placed on the F3 (anode, left frontal) and F4 (cathode, right frontal) EEG location. Subjects were given 2 mA stimulation intensity for 20 min per session including fade-in and fade-out times for 20 seconds each. Interval between each session was 20 min. Sham procedure has been adopted a Fade In of current, Short Stimulation, Fade Out (FISSFO) protocol that consist of initial ramp up for 20 seconds, 2 mA stimulation for 40 seconds, and 20 seconds for ramp down. To check to impendence, brief current of 110 µA over 15ms every 550ms was delivered. **Name:** Transcranial direct current stimulation **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** To achieve a more quantitative evaluation of tinnitus reduction, we assessed the Visual Analog Scale (VAS). **Measure:** Visual analogue scale (VAS) related to tinnitus **Time Frame:** All participants were checked the VAS immediately after the last stimulation of every week for 4 weeks and 8th week (4 weeks after the end of treatment). **Description:** The subjective improvement of tinnitus was evaluated using THI. **Measure:** Tinnitus Handicap Inventory (THI) **Time Frame:** THI was assessed at the 4th and 8th week visits. **Description:** To assess the association between tinnitus relief and depression, we evaluated the Beck Depression Inventory (BDI). **Measure:** Beck depression inventory (BDI) **Time Frame:** THI was assessed at the 4th and 8th week visits. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Individuals who have experienced subjective tinnitus for over 3 months. * Individuals with normal hearing, defined as an average pure tone threshold of less than 25 dB between 0.5-4 kHz, and the presence of the V wave at 30 dBnHL with a difference in V wave latency of less than 0.2 ms in both ears during the ABR test. * Individuals with severe tinnitus, as indicated by a Tinnitus Handicap Inventory (THI) score of 58 or higher, and who have been assessed for symptoms of anxiety and depressive mood using the Beck Depression Inventory (BDI) questionnaire. Exclusion Criteria: * Those requiring treatment for neurological disorders such as epilepsy, migraine, or intracranial masses. * Pregnant individuals on the day of providing consent and those with metal-based electric implantable prosthetics. * Individuals with objective or somatic tinnitus, auditory hallucinations, unwillingness to provide written consent, or unwillingness to continue the trial, and those who have participated in previous trials involving tDCS for tinnitus. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Hwaseong Si **Country:** Korea, Republic of **Facility:** Dongtan Sacred Heart Hospital **State:** Gyeonggi-Do **Zip:** 445-170 #### Overall Officials **Official 1:** **Affiliation:** University of Michigan **Name:** Sung Kyun Kim **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006311 - Term: Hearing Disorders - ID: D000004427 - Term: Ear Diseases - ID: D000010038 - Term: Otorhinolaryngologic Diseases - ID: D000012678 - Term: Sensation Disorders - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16769 - Name: Tinnitus - Relevance: HIGH - As Found: Tinnitus - ID: M9400 - Name: Hearing Disorders - Relevance: LOW - As Found: Unknown - ID: M7601 - Name: Ear Diseases - Relevance: LOW - As Found: Unknown - ID: M12961 - Name: Otorhinolaryngologic Diseases - Relevance: LOW - As Found: Unknown - ID: M15490 - Name: Sensation Disorders - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014012 - Term: Tinnitus ### 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:** NCT06423729 **Brief Title:** Effect of Nicorandil in Type 2 Diabetic Obese Patients **Official Title:** Clinical Study Evaluating the Effect of Nicorandil in Type 2 Diabetic Obese Patients Treated With Sulfonylurea #### Organization Study ID Info **ID:** Nicorandil in DM #### Organization **Class:** OTHER **Full Name:** Tanta University ### Status Module #### Completion Date **Date:** 2025-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Tanta University #### Responsible Party **Investigator Affiliation:** Tanta University **Investigator Full Name:** Merna Mohamed Seddik Ali **Investigator Title:** Merna Mohamed Seddik Ali , Master degree in Clinical Pharmacy, Tanta University **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** 1. Evaluating the effect of nicorandil on glycemic control of diabetic obese patients treated with sulfonylureas. 2. Investigating the effect of nicorandil on body weight of diabetic obese patients treated with sulfonylureas. ### Conditions Module **Conditions:** - Diabetes Mellitus, Type 2 **Keywords:** - Type 2 DM, Nicorandil, Obesity ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 46 **Type:** ESTIMATED **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 23 patients who will receive 2nd generation sulfonylureas only, for three months. **Label:** Control Arm **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** 23 patients who will receive a combination of 2nd generation sulfonylureas and nicorandil 10 mg twice daily,for three months. **Intervention Names:** - Drug: Nicorandil 10 MG **Label:** Nicorandil Arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Nicorandil Arm **Description:** Patients will receive oral Nicorandil 10 MG twice daily in addition to 2nd generation sulfonylureas , for 3 months. **Name:** Nicorandil 10 MG **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Change in HbA1c (From baseline to 12 weeks) **Measure:** Change in HbA1c level **Time Frame:** The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months. **Description:** Change in body weight (From baseline to 12 weeks). **Measure:** Change in body weight. **Time Frame:** The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months. **Description:** Change in Body mass index (BMI) (From baseline to 12 weeks). **Measure:** Change in Body mass index (BMI) **Time Frame:** The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months. **Description:** Change in Visceral adiposity index (VAI) (From baseline to 12 weeks). **Measure:** Change in Visceral adiposity index (VAI). **Time Frame:** The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months. #### Secondary Outcomes **Description:** Assessment of Adiponenctin, Interleukin-6 (IL-6) and Nitric oxide levels by ELISA Kits according to manufacturer's instructions. **Measure:** Change in Adiponenctin, Interleukin-6 (IL-6) and Nitric oxide (NO) serum levels. **Time Frame:** The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diabetes duration ranged from 1 to 10 years. * Body mass index (BMI) \>30 Kg/m2. * The selected patients are treated with sulfonylureas alone. * The age of selected patient ranged from 18 and 60 years. Exclusion Criteria: * Pregnant and lactating females. * Patients with hypersensitivity to nicorandil. * Uncontrolled hypertension and its antihypertensive medications * Severe renal or hepatic disease. **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Merna Mohamed Seddik Ali **Phone:** +201026064628 **Role:** CONTACT #### Locations **Location 1:** **City:** Tanta **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Merna Mohamed Seddik Ali, Master degree - **Phone:** +201026064628 - **Role:** CONTACT ***Contact 2:*** - **Name:** Merna Mohamed Seddik Ali - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Egypt **Facility:** Faculty of Pharmacy, Tanta University **Status:** RECRUITING **Zip:** 31511 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003920 - Term: Diabetes Mellitus - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: HIGH - As Found: Diabetes Mellitus, Type 2 - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003924 - Term: Diabetes Mellitus, Type 2 ### Intervention Browse Module - Ancestors - ID: D000000889 - Term: Anti-Arrhythmia Agents - ID: D000000959 - Term: Antihypertensive Agents - ID: D000014665 - Term: Vasodilator Agents - ID: D000014803 - Term: Vitamin B Complex - ID: D000014815 - Term: Vitamins - ID: D000018977 - Term: Micronutrients - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: AnAg - Name: Antihypertensive Agents - Abbrev: VaDiAg - Name: Vasodilator Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Hemat - Name: Hematinics - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M21946 - Name: Nicorandil - Relevance: HIGH - As Found: Anterior chamber - ID: M4213 - Name: Anti-Arrhythmia Agents - Relevance: LOW - As Found: Unknown - ID: M4277 - Name: Antihypertensive Agents - Relevance: LOW - As Found: Unknown - ID: M17412 - Name: Vasodilator 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: D000020108 - Term: Nicorandil ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423716 **Acronym:** RELIFE **Brief Title:** Effect of peRiopErative duLoxetIne Administration on Opioid Consumption Following Total kneE Arthroplasty (RELIFE) **Official Title:** Effect of Perioperative Duloxetine Administration on Opioid Consumption Following Total Knee Arthroplasty #### Organization Study ID Info **ID:** SBK 6156 #### Organization **Class:** OTHER **Full Name:** Sunnybrook Health Sciences Centre ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Sunnybrook Health Sciences Centre #### Responsible Party **Investigator Affiliation:** Sunnybrook Health Sciences Centre **Investigator Full Name:** Dr. Colin McCartney **Investigator Title:** Anesthesiologist, Pain Physician **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Knee replacement surgery for osteoarthritis is a commonly performed procedure in Canada with 75,000 of these surgeries performed each year. Success rate for knee replacement surgery is high but more than 20% of patients are still dissatisfied mainly due to reports of ongoing pain. Pain control following knee surgery is important in order to allow patients to engage in recovery and rehabilitation. The current standard of pain management after surgery centers around the use of opioids which is a concerning practice as highlighted by the opioid epidemic. Duloxetine is an antidepressant that has pain relieving properties and it has been studied in patients undergoing knee replacement surgery. Studies to date have not been designed optimally to demonstrate the full effects of opioid dose reduction and the use of duloxetine as a medication following knee replacement surgery. This research study seeks to start duloxetine before surgery, at the recommended therapeutic dose, and for the duration of the early rehabilitation period. If the study is successful, this low-cost medication can improve satisfaction rates and change the standard way the pain management is typically carried out for patients undergoing the knee replacement surgery. **Detailed Description:** The use of duloxetine around the time of total knee arthroplasty has emerged as a promising intervention to help with pain management after surgery and in particular as an opioid sparing agent. Duloxetine is an antidepressant with serotonin and norepinephrine reuptake inhibition effects that also independently exerts an analgesic effect. Duloxetine is Health Canada approved for several indications including pain arising from osteoarthritis of the knee. Pain inhibition action of duloxetine is believed to be a result of potentiation of descending inhibitory pain pathways within the central nervous system. Existing studies examining duloxetine use at the time of surgery has demonstrated statistically significant but less clinically meaningful impacts on opioid sparing and pain reduction. The deficiencies in study design of existing studies have either underdosed duloxetine (30mg instead of the recommended 60mg) and/or utilized non-standard duration of therapy (started too late, continued for only 2 weeks). Our study seeks to definitively address whether duloxetine administered 2 weeks preoperatively at 60mg once daily, in addition to standard analgesic practice, will decrease opioid consumption at 1 week postoperatively. Prospective, randomized, blinded (investigators, clinicians, participant, data collectors/analysts) trial. Primary Outcome •Cumulative opioid consumption at 1 week post-operatively. Secondary Outcomes * Nausea/vomiting * Discharged according to plan (ie. same day went home same day, or day 1 went home day 1) and if not, reason * Pain at rest and with activity (NRS-11) at 1, 6, and 12 weeks and 4.5 months * Additional analgesic use (anti-neuropathic medications, family physician or orthopaedic surgeon opioid prescription) * Physical function (BPI, Oxford Knee Scale, range of motion * Emotional function (GAD-7, PHQ-9 at 6 weeks and 12 weeks) * Number of rehabilitation sessions attended (in-person or virtual) * Patient satisfaction (PGIC) at 1, 6, and 12 weeks after medication initiation * Presence of neuropathic pain (S-LANSS) at 6 and 12 weeks * Presence of chronic post-surgical pain at 12 weeks (based on NRS \&gt; 0) * Adverse events relating to study medication (dizziness, drowsiness, nausea, vomiting, insomnia) * Intervention adherence Interventional medication supply: Duloxetine 60mg OD for 2 weeks preoperatively then 60mg OD for 6 weeks post-surgery. Standard of care: On the day of surgery, participants will be premedicated with acetaminophen (1000mg) and celecoxib (400mg). Per standard of care, all participants will receive an ultrasound guided adductor canal catheter (bolus ropivacaine 0.5% 10ml). This will be followed by a spinal anesthetic with mepivacaine 2% 3ml and 10mcg of fentanyl. Intraoperative sedation will consist of a propofol infusion titrated to SAS (Sedation Agitation Scale) of 3-4. All TKAs will be performed using a standard medial parapatellar approach and the same cemented total knee system. Tourniquet will be applied and used as part of the case. Periarticular local infiltration will be used per standard practice using ropivacaine 0.2% with 1:200 000 epinephrine up to 50ml. Post-surgery: Participants will be evaluated on POD-0, POD-1 and POD-2 while in hospital or at home through phone call and at 1, 6, and 12 weeks. Participant satisfaction will be assessed using the Patients' Global Impression of Change (PGIC) Scale at 1, 6, and 12 weeks post-surgery. Pain scores and opioid consumption will be recorded daily for 1 week post-operatively. Patients will record their pain and opioid consumption on a weekly basis until week 12 post-operatively. Physical function, emotional function, and presence of neuropathic pain will be collected at 6 and 12 weeks. Active and passive range of motion will be assessed by orthopedic surgeon using goniometer at 6 (+/-1 week) and 12 (+/-1 week) weeks and 4.5 month (+/-2 weeks) postoperatively. Group 1: Intervention Duloxetine 60mg OD for 2 weeks preoperatively then 60mg OD for 6 weeks post-surgery. Group 2: Control Placebo OD for 2 weeks preoperatively then OD for 6 weeks post-surgery. Both Groups: On the day of surgery, standard post-anesthetic care unit (PACU) orderset will be employed and the postoperative analgesic regimen will follow standard of care including: acetaminophen 1g QID, celecoxib 200mg BID, and hydromorphone 1-3mg PO q2h PRN. * Nurse administered IV hydromorphone push (0.3mg) followed by IV PCA hydromorphone if pain is not controlled * ACB catheter ropivacaine 0.15% at 5cc/hr, stopped at 6:00am on POD-1 Participants will be discharged on POD-0, POD-1 or POD-2 with acetaminophen 1000mg TID, celecoxib 100mg BID, and hydromorphone (2-4mg PO q4h PRN). Patients for same-day discharge (POD-0) will have ACB catheter bolus of 10cc of 0.5% ropivacaine prior to removal. ### Conditions Module **Conditions:** - Knee Osteoarthritis **Keywords:** - total knee arthroplasty - duloxetine - postoperative pain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Group 1: Intervention Duloxetine 60mg OD for 2 weeks preoperatively then 60mg OD for 6 weeks post-surgery. Group 2: Control Placebo OD for 2 weeks preoperatively then OD for 6 weeks post-surgery. ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Duloxetine 60mg OD for 2 weeks preoperatively then 60mg OD for 6 weeks post-surgery. **Intervention Names:** - Drug: Duloxetine **Label:** Intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Placebo OD for 2 weeks preoperatively then OD for 6 weeks post-surgery. **Intervention Names:** - Drug: Placebo **Label:** Control **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention **Description:** 60mg duloxetine given 2 weeks prior to total knee arthroplasty and continued for 6 weeks after surgery. **Name:** Duloxetine **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Control **Description:** Placebo given 2 weeks prior to total knee arthroplasty and continued for 6 weeks after surgery. **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Cumulative opioid consumption at 1 week post-operatively **Measure:** Opioid consumption **Time Frame:** Cumulative opioid consumption at 1 week post-operatively #### Secondary Outcomes **Description:** Presence of nausea or vomiting **Measure:** Nausea/vomiting **Time Frame:** 8 weeks (i.e., duration of study) **Description:** Maximum pain score on 0-10 Likert Scale (NRS) **Measure:** Pain at rest and with activity **Time Frame:** 10-14 days preoperative; 1,6,12 weeks and 4.5 months **Description:** Anti-neuropathic medications **Measure:** Additional analgesic use **Time Frame:** 8 weeks (i.e., duration of study) **Description:** Family physician or orthopaedic surgeon opioid prescription **Measure:** Additional analgesic use: opioid prescription **Time Frame:** 8 weeks (i.e., duration of study) **Description:** Brief Pain Inventory **Measure:** Physical function measured by BPI **Time Frame:** Preoperative, 6, 12 weeks and 4.5 months **Description:** Oxford Knee Scale **Measure:** Physical function measured by Oxford Knee Scale **Time Frame:** Preoperative, 6, 12 weeks and 4.5 months **Measure:** Range of motion: Physical function **Time Frame:** Preoperative, 6, 12 weeks and 4.5 months **Description:** GAD-7 **Measure:** Emotional function measured by GAD-7 **Time Frame:** Preoperative, 6, 12 weeks and 4.5 months **Description:** PHQ-9 **Measure:** Emotional function measured by PHQ-9 **Time Frame:** Preoperative, 6, 12 weeks and 4.5 months **Description:** Patient global impression of change (PGIC) **Measure:** Patient satisfaction **Time Frame:** 1, 6, and 12 weeks after surgery **Description:** Presence of neuropathic pain (S-LANSS) **Measure:** Neuropathic pain **Time Frame:** 6 and 12 weeks post-surgery **Description:** Presence of chronic post-surgical pain (based on NRS \> 0) **Measure:** Chronic post-surgical pain **Time Frame:** 12 weeks post-surgery **Description:** Adverse events relating to study medication (dizziness, drowsiness, nausea, vomiting, insomnia) **Measure:** Adverse events **Time Frame:** in hospital at POD1-3, 1 week post-discharge ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age \>=50 2. Presence of knee osteoarthritis 3. Planned for elective unilateral total knee arthroplasty 4. ASA I - III Exclusion Criteria: 1. Lack of patient consent; unlikely to comply with follow-up 2. Presence of contraindications to study drug use: * Known hypersensitivity to the drug or components of the product * Known liver disease - history of cirrhosis, non-alcoholic steatohepatitis * Uncontrolled narrow - angle glaucoma * Severe renal impairment (CrCl\<30mL/min) * Concurrent use of thioridazine * Concurrent use of potent CYP1A2 inhibitors (e.g. fluvoxamine) and some quinolone antibiotics (e.g. ciprofloxacin or enoxacin) * Concurrent use of antidepressants (e.g. MAOI, SSRI, SNRI, TCA, St. John's Wort, buspirone) * Concurrent use of triptan or lithium 3. Chronic and high dose opioid use (\&gt;30mg oral morphine equivalent per day) 4. Substance use disorder (cannabis and related products, alcohol use disorder, opioid used disorder, illicit drugs) 5. Uncontrolled hypertension (systolic BP \&gt; 180mmHg) 6. Untreated psychiatric illness (e.g. depression, suicidal ideation, bipolar disorder) 7. Involved in worker's compensation case/law suit (verbally declared by patient) **Minimum Age:** 50 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Howard Meng, MD **Phone:** 416-480-4864 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Stephen Choi **Phone:** 416-480 -4864 **Role:** CONTACT #### Locations **Location 1:** **City:** Toronto **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Lilia Kaustov, PhD - **Phone:** 416-480-6100 - **Phone Ext:** 89607 - **Role:** CONTACT ***Contact 2:*** - **Name:** Stephen Choi, MD - **Role:** SUB_INVESTIGATOR ***Contact 3:*** - **Name:** Sebastian Tomescu, MD - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Howard Meng, MD - **Role:** SUB_INVESTIGATOR **Country:** Canada **Facility:** Sunnybrook Health Sciences Centre **State:** Ontario **Zip:** M4N 3M5 ### IPD Sharing Statement Module **Access Criteria:** Contact study investigators **Description:** De-identified data will be available upon request **Info Types:** - STUDY_PROTOCOL - SAP - ICF **IPD Sharing:** YES **Time Frame:** Upon publication, no limit on time ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M13069 - Name: Pain, Postoperative - Relevance: LOW - As Found: Unknown - ID: M22168 - Name: Osteoarthritis, Knee - Relevance: HIGH - As Found: Knee Osteoarthritis - ID: M12926 - Name: Osteoarthritis - Relevance: HIGH - As Found: Osteoarthritis - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010003 - Term: Osteoarthritis - ID: D000020370 - Term: Osteoarthritis, Knee ### Intervention Browse Module - Ancestors - ID: D000068760 - Term: Serotonin and Noradrenaline Reuptake Inhibitors - ID: D000014179 - Term: Neurotransmitter Uptake Inhibitors - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000018377 - Term: Neurotransmitter Agents - 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: D000000928 - Term: Antidepressive Agents - ID: D000011619 - Term: Psychotropic Drugs - ID: D000015259 - Term: Dopamine Agents ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: VaCoAg - Name: Vasoconstrictor Agents - Abbrev: CaAg - Name: Cardiotonic Agents ### Intervention Browse Module - Browse Leaves - ID: M299 - Name: Duloxetine Hydrochloride - Relevance: HIGH - As Found: Arm 1 - ID: M4033 - Name: Analgesics, Opioid - Relevance: LOW - As Found: Unknown - ID: M12575 - Name: Norepinephrine - Relevance: LOW - As Found: Unknown - ID: M15512 - Name: Serotonin - Relevance: LOW - As Found: Unknown - ID: M305 - Name: Serotonin and Noradrenaline Reuptake Inhibitors - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M4247 - Name: Antidepressive Agents - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown - ID: M7473 - Name: Dopamine - Relevance: LOW - As Found: Unknown - ID: M17962 - Name: Dopamine Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000068736 - Term: Duloxetine Hydrochloride ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423703 **Acronym:** ALLEVIATE2 **Brief Title:** A Study of Cebranopadol for the Treatment of Acute Pain After Bunionectomy **Official Title:** A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of Cebranopadol for the Treatment of Moderate to Severe Acute Pain After Primary Unilateral Bunionectomy #### Organization Study ID Info **ID:** TRN-228-302 #### Organization **Class:** INDUSTRY **Full Name:** Tris Pharma, Inc. ### Status Module #### Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Tris Pharma, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to evaluate the efficacy and safety of Cebranopadol for acute pain after a bunionectomy. **Detailed Description:** This study is a Phase 3, multicenter, randomized, double-blind, placebo- and active-controlled parallel-group study to evaluate the efficacy and safety of cebranopadol in the treatment of postoperative pain following primary unilateral bunionectomy with first metatarsal osteotomy. The study will be conducted in 3 phases: Screening, Treatment, and Follow-up. ### Conditions Module **Conditions:** - Acute Pain **Keywords:** - Bunionectomy ### 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:** 240 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** once daily for 3 days **Intervention Names:** - Drug: Cebranopadol - Drug: Placebo **Label:** Cebranopadol **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** four times per day for 3 days **Intervention Names:** - Drug: Oxycodone IR **Label:** Oxycodone IR **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** three times per day 3 days (with cebranopadol); four times per day for 3 days (placebo arm) **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Cebranopadol **Description:** once daily for 3 days **Name:** Cebranopadol **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Oxycodone IR **Description:** four times per day for 3 days **Name:** Oxycodone IR **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Cebranopadol - Placebo **Description:** three times per day 3 days (with cebranopadol), four times per day for 3 days (placebo arm) **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Other Outcomes **Measure:** Incidence of Respiratory Safety Events **Time Frame:** 0-72 hours #### Primary Outcomes **Measure:** Pain NRS area under the curve: cebranopadol vs. placebo **Time Frame:** 2-48 hours #### Secondary Outcomes **Measure:** Proportion of subjects who require opioid rescue medication **Time Frame:** 0-72 hours **Measure:** Global Assessment of Satisfaction **Time Frame:** 0-72 hours **Measure:** Total oxycodone rescue consumption **Time Frame:** 0-72 hours ### Eligibility Module **Eligibility Criteria:** Key Inclusion Criteria Before Surgery: * Scheduled to undergo primary unilateral bunionectomy with first metatarsal osteotomy and internal fixation with no collateral procedures, using anesthesiologic and surgical procedures planned * Must be able to adhere to the visit schedule, complete all study assessments and protocol requirements, including self-reported questionnaires. Key Exclusion Criteria Before Surgery: * Any clinically significant disease, medical condition, or laboratory finding that in the investigator's opinion may interfere with the study procedures or data integrity, or compromise the safety of the subject. * Secondary (i.e., unrelated to bunion) current painful condition that could confound the interpretation of efficacy, safety, or tolerability data in the study, in the opinion of the investigator. * Subjects who require any analgesic for secondary (i.e., unrelated to bunion) painful condition that might impact the subject's ability to properly assess their postoperative pain, or that may require treatment during the Treatment Phase. * History of allergy or hypersensitivity to any opioid analgesics, anesthetics, ibuprofen, or other NSAIDs. Immediate Postoperative Exclusion Criteria: * Surgical, postsurgical, or anesthetic complication that could confound the interpretation of efficacy, safety, or tolerability data in the study. * Deviation from the surgical, postsurgical, or anesthetic protocol that could confound the interpretation of efficacy, safety, or tolerability data in the study. * Evidence of hemodynamic instability or respiratory insufficiency. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Antonio Pardo, MD **Phone:** 732-823-4755 **Role:** CONTACT #### Locations **Location 1:** **City:** Sheffield **Country:** United States **Facility:** ALLEVIATE 2 Site 001108 **State:** Alabama **Zip:** 35660 **Location 2:** **City:** Little Rock **Country:** United States **Facility:** ALLEVIATE 2 Site 001106 **State:** Arkansas **Zip:** 72211 **Location 3:** **City:** Tampa **Country:** United States **Facility:** ALLEVIATE 2 Site 001103 **State:** Florida **Zip:** 33613 **Location 4:** **City:** Atlanta **Country:** United States **Facility:** ALLEVIATE 2 Site 001102 **State:** Georgia **Zip:** 30331 **Location 5:** **City:** Overland Park **Country:** United States **Facility:** ALLEVIATE 2 Site 001107 **State:** Kansas **Zip:** 66212 **Location 6:** **City:** Pasadena **Country:** United States **Facility:** ALLEVIATE 2 Site 001105 **State:** Maryland **Zip:** 21122 **Location 7:** **City:** McAllen **Country:** United States **Facility:** ALLEVIATE 2 Site 001104 **State:** Texas **Zip:** 78501 **Location 8:** **City:** Salt Lake City **Country:** United States **Facility:** ALLEVIATE 2 Site 001101 **State:** Utah **Zip:** 84107 #### Overall Officials **Official 1:** **Affiliation:** CenExel JBR **Name:** Todd M Bertoch, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M29525 - Name: Acute Pain - Relevance: HIGH - As Found: Acute Pain - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000059787 - Term: Acute Pain ### 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 ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M13020 - Name: Oxycodone - Relevance: HIGH - As Found: Valve - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M4033 - Name: Analgesics, Opioid - Relevance: LOW - As Found: Unknown - ID: M12245 - Name: Narcotics - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000010098 - Term: Oxycodone ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423690 **Brief Title:** First in Human Study for the Assessment of Safety and Initial Performance of the EAS1 System **Official Title:** Snipe Medical First In Human Study #### Organization Study ID Info **ID:** PRC015 #### Organization **Class:** INDUSTRY **Full Name:** Snipe Medical ### Status Module #### Completion Date **Date:** 2025-02-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-01-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Snipe Medical #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** A Prospective, open label, multi center, single arm, First in Human study to assess the safety and initial performance of EAS1 system for Irreversible Electroporation (IRE) ablation of lung cancer in subjects eligible for tumor resection ### Conditions Module **Conditions:** - Lung Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 15 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Ablation of the lung tumor via Irreversible Electroporation (IRE) method, followed by resection of the tumor up to 14 days after the ablation **Intervention Names:** - Device: EAS1 System **Label:** Treatment Arm - Ablation with EAS1 System **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment Arm - Ablation with EAS1 System **Description:** tumor ablation system in IRE method **Name:** EAS1 System **Type:** DEVICE ### Outcomes Module #### Other Outcomes **Description:** Investigator satisfaction, as determined by completing an internal ease-of-use questionnaire following each procedure. The questionnaire consists of 10 questions, each ranging from 1 (not at all) to 5 (very much). Range of total score is 10-50, where the higher the total score, the more satisfied the investigator is from device use **Measure:** Investigator's Impression of the Treatment (Investigator's Satisfaction) **Time Frame:** 30 days **Description:** Immunological response, as determined by change from baseline to 30 day FU in immunological blood markers. **Measure:** Assessment of Immunological Response Following Ablation **Time Frame:** 30 days #### Primary Outcomes **Description:** Accumulative rate of device related Serious Adverse Events (SAEs) during the ablation and up to 48 hours post ablation **Measure:** Safety of the EAS1 System in Lung Tumor Ablation During Procedure **Time Frame:** 48 hours post procedure #### Secondary Outcomes **Description:** Rate of device related SAEs during the follow up period **Measure:** Safety of the EAS1 System in Lung Tumor Ablation Throughout Follow Up **Time Frame:** 30 days **Description:** - Technical success, defined as the investigator's ability to access the target tumor and successfully perform the irreversible electroporation, as confirmed by histology analysis **Measure:** Investigator's Ability to Approach and Ablate the Tumor (Technical Success) **Time Frame:** 30 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult male and female subjects (age ≥18 years at the date of informed consent signature) * Subject is capable and willing to provide an informed consent * Subjects with a known diagnosis of lung cancer at cT1a-T1c, cN0 stages * At least one pulmonary tumor (primary or metastasis) ≤ 30 mm in maximal diameter, as confirmed by the latest standard of care imaging (CT/MRI), performed preferably up to 30 days prior to screening * Subjects who are scheduled or deemed eligible by a thoracic surgeon for lung tumor resection * Subject is able and willing to comply with the study procedures and visits * There is ≥ 5mm of nodule-free lung parenchyma between target nodule and pleura or fissure, as confirmed by the latest standard of care imaging (CT/MRI), performed preferably up to 30 days prior to screening * ECOG 0-1 * Stable doses of concomitant medications for at least four (4) weeks prior to enrollment Exclusion Criteria: * An inability to provide informed consent * Subjects with contraindication for tumor resection * Subjects with life expectancy \<12 months * Target nodule is abutting main stem bronchus, main pulmonary vasculature, esophagus and/or trachea * Subjects with Forced Expiratory Volume (FEV1) \<50% * Total Lung Capacity (TLC)\< 80% of expected for age * Diffusing Capacity (DCO) \< 60% of expected * Oxygen saturation in free air of \<88%, or requiring more than 2 l/min oxygen to achieve saturation of 92% * PCO2 of ≥ 45mm/Hg * Subjects in exacerbations group E (high risk; ≥2 exacerbations per year or ≥1 requiring hospitalization and any level of symptoms) * Severe emphysema, Bullous Emphysema or chronic obstructive pulmonary disease (COPD) (GOLD III/IV) * Active and/or prolonged lung or bronchi infection, required an antibiotic treatment up to 21 days prior to screening and for more than 10 days of treatment * Known history or current evidence of a significant bronchiectasis * Evidence of lung Bullae the occupies more than one third of the lung intended for ablation * Previous surgery in the lung intended for ablation; thoracic major surgery at the side intended for ablation * Anticoagulation treatment that cannot be discontinued prior to the ablation, or a bleeding diathesis or platelets \<100 )K/µl) * Pregnant or breastfeeding female subjects or female subjects who plan pregnancy during participation in the study * Highly hypoxemic patients, according to investigator's discretion * Subjects with implanted metal or electronic thoracic devices objects (such as pacemaker) that cannot be removed prior to procedure * Subjects with contraindication for bronchoscopy * Participation in any other interventional clinical trial with medication, medical device and/or supplements within 30 days prior to informed consent signature * Any subject who, at the discretion of the investigator, may be jeopardized by study participation **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Emily Ben Shlomo **Phone:** 972523212687 **Role:** CONTACT #### Locations **Location 1:** **City:** Kfar Saba **Contacts:** ***Contact 1:*** - **Email:** "[email protected]" <[email protected]> - **Name:** Emily Ben Shlomo - **Role:** CONTACT ***Contact 2:*** - **Name:** Eyal Romem, Dr - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Israel **Facility:** Meir Medical Center **Location 2:** **City:** Salamanca **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Marcelo Jimenez, Dr - **Phone:** +34923291100 - **Phone Ext:** 55383 - **Role:** CONTACT ***Contact 2:*** - **Name:** Marcelo Jimenez, Dr. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** University Hospital Complex of Salamanca **Location 3:** **City:** London **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Anand Tana - **Phone:** +44 207 352 8121 - **Role:** CONTACT ***Contact 2:*** - **Name:** Pallav Shah, Dr - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United Kingdom **Facility:** Royal Brompton Hospital #### Overall Officials **Official 1:** **Affiliation:** Principal investigator at Meir Medical Center **Name:** Eyal Romem, Dr **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423677 **Brief Title:** Analgesic Efficacy of Serratus Posterior Superior Intercostal Plane (SPSIP) Block in Shoulder Arthroscopies **Official Title:** Evaluation of the Analgesic Efficacy of Serratus Posterior Superior Intercostal Plane (SPSIP) Block in Shoulder Arthroscopies: A Randomized Controlled Prospective Multicenter Study #### Organization Study ID Info **ID:** Serratus Posterior Superior #### Organization **Class:** OTHER **Full Name:** Kanuni Sultan Suleyman Training and Research Hospital ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-25 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Kanuni Sultan Suleyman Training and Research Hospital #### Responsible Party **Investigator Affiliation:** Kanuni Sultan Suleyman Training and Research Hospital **Investigator Full Name:** Engin Ihsan Turan **Investigator Title:** Specialist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Patients in the block group will be placed in a lateral position with the operated shoulder on top before awakening from surgery. After ensuring aseptic conditions (the block site will be wiped three times with 10% povidone-iodine), the linear ultrasound probe will be covered in a sterile manner. While performing the block, the Hitachi brand linear ultrasound probe will be placed parallel to the scapular spine on the surgical side and will be slid medially. After imaging the 2nd and 3rd ribs on the medial side of the scapular spine, the block needle will be advanced under ultrasound guidance onto the 3rd rib. After contacting the rib with the needle, it will be retracted by 1mm, and the block site will be confirmed by injecting sterile 0.9% NaCl. Subsequently, patients will be administered 30ml of 0.25% bupivacaine in a controlled manner. Before awakening, both the block group and the non-block group will be administered 1g of paracetamol and 1mg/kg of tramadol intravenously. In the postoperative period, these patients will be provided with multimodal analgesia, including intravenous patient-controlled analgesia (PCA) with 4mg/ml Tramadol HCl in 100ml NaCl. There will be no basal infusion, with bolus doses of 20mg and a lockout period of 20 minutes, and a total dose limitation of 200mg over 4 hours. Patients will be visited at 0, 1, 6, 12, and 24 hours, and they will be asked to draw their visual analog scale (VAS) score on a paper scale. The amount of opioid used in the PCA and the need for rescue analgesia (Arveles 50mg intravenously) will be assessed. Patients will routinely receive 4x1g paracetamol in the postoperative period. ### Conditions Module **Conditions:** - Pain, Postoperative - Shoulder Pain - Block ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 52 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** serratus posterior superior intercostal plane block will be administered to these group. after the extubation intravenous patient controlled analgesia (PCA) will also be administered to patients. **Intervention Names:** - Procedure: Serratus Posterior Superior Intercostal Plane Block - Device: patient controlled analgesia **Label:** serratus posterior superior intercostal plane block + intravenous patient controlled analgesia **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** After the extubation, only intravenous patient controlled analgesia (PCA) will be administered to patients. **Intervention Names:** - Device: patient controlled analgesia **Label:** intravenous patient controlled analgesia **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - serratus posterior superior intercostal plane block + intravenous patient controlled analgesia **Description:** The Serratus Posterior Superior Intercostal Plane Block will be performed under ultrasound guidance. During the block, a linear ultrasound probe will be placed parallel to the spine of the scapula on the surgical side and then slid medially. The block needle will be advanced under ultrasound guidance over the 3rd rib. After the needle touches the rib, it will be withdrawn by 1mm, and the block site will be confirmed by injecting sterile 0.9% NaCl. Subsequently, patients will be administered 50mg of bupivacaine and 100mg of lidocaine in a controlled manner. **Name:** Serratus Posterior Superior Intercostal Plane Block **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - intravenous patient controlled analgesia - serratus posterior superior intercostal plane block + intravenous patient controlled analgesia **Description:** intravenous patient-controlled analgesia (PCA) with 4mg/ml Tramadol HCl in 100ml NaCl. There will be no basal infusion, with bolus doses of 20mg and a lockout period of 20 minutes, and a total dose limitation of 200mg over 4 hours **Name:** patient controlled analgesia **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Patients will be visited at 0, 1, 6, 12, and 24 hours, and they will be asked to draw their visual analog scale (VAS) score on a paper scale.0 means no pain, 10 means the most intense pain. 4 or more Visual analog scale scores means patients need rescue analgesia. **Measure:** visual analog scale score **Time Frame:** 0, 1, 6, 12, and 24 hours **Description:** Patients will be visited at 0, 1, 6, 12, and 24 hours and opioid consumption in the patient controlled analgesia device will be noted.0 means no pain, 10 means the most intense pain. 4 or more Visual analog scale scores means patients need rescue analgesia. **Measure:** opioid consumption **Time Frame:** 0, 1, 6, 12, and 24 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Obtaining consent from the patient and their relative * ASA score of I-II * No bleeding diathesis * No history of anticoagulant use * No history of neuropathic diseases such as Diabetes Mellitus * Patients aged 18-65 years undergoing shoulder arthroscopy surgery Exclusion Criteria: * Lack of consent from the patient or their relative * Patients with an ASA score of III or above * Patients with a history of bleeding diathesis * Conditions where regional anesthesia is contraindicated * Patients with a history of neuropathic diseases * Patients under 18 years or over 65 years of age * Patients with a history of allergies to the aforementioned medications * Patients with an infection at the site where the block will be administered **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Engin ihsan Turan **Phone:** +9005382431114 **Role:** CONTACT #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital **Zip:** 34303 #### Overall Officials **Official 1:** **Affiliation:** Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital **Name:** Engin ihsan Turan **Role:** PRINCIPAL_INVESTIGATOR ## 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 - ID: D000018771 - Term: Arthralgia - 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: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M13069 - Name: Pain, Postoperative - Relevance: HIGH - As Found: Pain, Postoperative - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M21907 - Name: Shoulder Pain - Relevance: HIGH - As Found: Shoulder Pain - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M20833 - Name: Arthralgia - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000020069 - Term: Shoulder Pain - ID: D000010149 - Term: Pain, Postoperative ### 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: 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: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M16901 - Name: Tramadol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423664 **Acronym:** INTACT **Brief Title:** Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure **Official Title:** Pilot Feasibility Trial of Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure (INTACT) #### Organization Study ID Info **ID:** 276534 #### Organization **Class:** NETWORK **Full Name:** IDeA States Pediatric Clinical Trials Network ### Status Module #### Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-17 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of New Mexico **Class:** OTHER **Name:** University of Vermont **Class:** UNKNOWN **Name:** Avera Research Institute **Class:** NIH **Name:** National Institutes of Health (NIH) #### Lead Sponsor **Class:** NETWORK **Name:** IDeA States Pediatric Clinical Trials Network #### 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 INTACT trial is a multisite pilot feasibility study aimed at testing the effectiveness of the INTACT Intervention program in improving neurodevelopmental outcomes in infants prenatally exposed to cannabinoids. The trial will enroll 20 birthing parent/infant dyads across three sites and will evaluate feasibility endpoints rather than clinical outcomes. The study duration is 22 months, including study start-up, enrollment and intervention, and data analysis and manuscript preparation. **Detailed Description:** The INTACT trial is designed to address the need for interventions to improve neurodevelopmental outcomes in infants exposed to cannabinoids in utero. It is a multi-site pilot study conducted across three Institutional Development Award (IDeA) States Pediatric Clinical Trials Network (ISPCTN) sites. The trial aims to evaluate the feasibility of the INTACT Intervention program, which focuses on training birthing parents in contingent responding to promote early language, cognitive, and social development in their infants. The study intervention consists of 12 monthly INTACT intervention coaching sessions, each comprising online module completion followed by personalized coaching sessions with interventionists certified to deliver the Play and Learn Strategies (PALS) methodology, which forms the basis for the INTACT intervention. The online modules focus on strengthening effective parenting practices, while the coaching sessions guide birthing parents in contingent responding techniques, such as reading infant signals and responding with warm and sensitive behaviors. There are three objectives for this study, examining 1) Participant Recruitment, 2) Participant Completion, and 3) Participant Adherence. Objective 1 examines if birthing parents can be recruited and enrolled in the study. The endpoint of this objective is the percentage of potential participants approached for the study that are consented and determined to be eligible for study participation. Objective 2 evaluates participant completion, as measured by the percent of birthing parent/infant dyads that complete the coaching session scheduled when the child is 12 months of age. Objective 3 evaluates the number of individual INTACT intervention coaching sessions completed. The study duration is planned for 22 months, including 1-4 months for study development and start-up, 3 months for enrollment, 12 months for the intervention, and 3 months for data organization, clean-up, and manuscript preparation. The INTACT trial will not assess clinical outcomes but will inform the design of a future larger-scale clinical trial to evaluate the effectiveness of the INTACT Intervention program in improving neurodevelopmental outcomes in infants prenatally exposed to cannabinoids. ### Conditions Module **Conditions:** - Developmental Delay **Keywords:** - Infants exposed to cannabinoids in-utero and their birthing parent. ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** A single-arm pilot study to assess feasibility of study procedures. ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A novel program to train birthing parents in contingent responding with the goal of improving neurodevelopmental outcomes in infants prenatally exposed to cannabinoids. 1 personalized coaching session per month for 12 months. **Intervention Names:** - Behavioral: Play and Learn Strategies (PALS) Program **Label:** Personalized coaching sessions **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Personalized coaching sessions **Description:** Monthly modules and personalized coaching sessions designed to strengthen maternal responsiveness and sensitivity which, in turn, improves infant social-emotional behavior and development outcomes. **Name:** Play and Learn Strategies (PALS) Program **Other Names:** - ePALS **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Whether a potential participant approached for study participation will eventually be consented and determined to be eligible for study participation. **Measure:** Participant Recruitment **Time Frame:** 3 months **Description:** Whether a birthing parent/infant dyad will complete the final coaching session when the child is 12 months of age. **Measure:** Participant Completion **Time Frame:** 12 months following enrollment **Description:** Whether a participant will complete the sufficient number of INTACT intervention coaching sessions, defined as completion of at least 8 out of 12 coaching sessions. **Measure:** Participant Adherence **Time Frame:** 12 months following enrollment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Birthing Parent * Age of majority, as defined by the state of residency * Cannabinoid use during pregnancy confirmed with self-report * Have the ability to speak, read, and understand English * Birthing parent who delivered at one of the hospitals where study team members have clinical privileges to access medical records * Has parental custody of the infant * Singleton pregnancy with live birth * Has an electronic device capable of watching videos and able to stream/download videos for viewing and permitting video conferencing * Has study access to the internet Infant * Term infants at birth (\>37 weeks' gestation) * Biological child of the birthing parent Exclusion Criteria: Birthing Parent * Other illicit drug use, excluding cannabinoids, during pregnancy (such as heroin or cocaine) per self-reported or toxicology results * Opiate use (prescribed or unprescribed) per self-report or toxicology results during this pregnancy * Prolonged hospitalization following delivery longer than 7 days Infant * Has major birth defect(s) including physical anomalies including limb malformations/absence of limbs or chromosomal abnormalities * Diagnosed with neonatal encephalopathy, metabolic disorder, stroke, intracranial hemorrhage, or meningitis during birth hospitalization * Received any major surgical intervention during the birth hospitalization or required a prolonged birth hospitalization (prolonged hospitalization being any hospitalization longer than 7 days) **Healthy Volunteers:** True **Maximum Age:** 7 Days **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jessica Snowden, MD **Phone:** (501) 686-5647 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Matthew Henry, MSc **Phone:** (501) 686-5647 **Role:** CONTACT #### Locations **Location 1:** **City:** Albuquerque **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jessie Maxwell, MD - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Sandra Beauman, MSN - **Role:** CONTACT **Country:** United States **Facility:** University of New Mexico Health Sciences Center **State:** New Mexico **Zip:** 87131 **Location 2:** **City:** Sioux Falls **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Maria Barber, DO - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Meggie McCoy, BS - **Phone:** (605) 504-3154 - **Role:** CONTACT ***Contact 3:*** - **Name:** Maria Barber, DO - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Avera Research Institute **State:** South Dakota **Zip:** 57108 **Location 3:** **City:** Burlington **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Leigh-Anne Cioffredi, MD - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Laurie Chassereau, RN - **Role:** CONTACT **Country:** United States **Facility:** University of Vermont Medical Center **State:** Vermont **Zip:** 05401 #### Overall Officials **Official 1:** **Affiliation:** University of New Mexico **Name:** Jessie Maxwell, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** University of Vermont **Name:** Leigh-Anne Cioffredi, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** Avera Research Institute **Name:** Maria Barber, DO **Role:** PRINCIPAL_INVESTIGATOR **Official 4:** **Affiliation:** University of Arkansas **Name:** Song Ounpraseuth, PhD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** to be announced **Description:** We will conduct this trial in accordance with the following publication and data sharing policies and regulations: NIH Public Access Policy. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication. ECHO ISPCTN Publications and Presentations Policy. It ensures accurate, responsible, and efficient communication of findings from ECHO ISPCTN clinical trials. NIH Data Sharing Policy and the policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Resulting Information Submission Rule. Other researchers may request data from this trial by contacting Song Ounpraseugh, PhD, at the ISPCTN Data Coordinating and Operations Center (DCOC). **Info Types:** - SAP - ICF **IPD Sharing:** YES **Time Frame:** Per data sharing polices of NIH and the ISPCTN ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423651 **Acronym:** CR+MCTp **Brief Title:** Benefits of Combining MCT With CR in the Recovery of Patients With Psychotic Spectrum Disorders **Official Title:** Benefits of Combining Metacognitive Training (MCT) With Cognitive Remediation (CR) in the Recovery of Patients With Psychotic Spectrum Disorders (CR+MCTp) #### Organization Study ID Info **ID:** PID2020-118907RA-I00 #### Organization **Class:** OTHER **Full Name:** Universitat Autonoma de Barcelona ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2022-09-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Parc Sanitari Sant Joan de Déu **Class:** OTHER **Name:** Consorci Sanitari de Terrassa **Class:** OTHER **Name:** Hospital de Mataró **Class:** OTHER **Name:** Centre d'Higiene Mental Les Corts **Class:** UNKNOWN **Name:** Fundació Els 3 Turons **Class:** OTHER **Name:** Hospital San Carlos, Madrid **Class:** OTHER_GOV **Name:** Andaluz Health Service **Class:** OTHER **Name:** Institut d'Assistència Sanitària **Class:** UNKNOWN **Name:** Ministerio de Ciencia, Innovación y Universidades **Class:** OTHER **Name:** Hospital Son Espases **Class:** OTHER **Name:** Parc Taulí Hospital Universitari **Class:** OTHER **Name:** Servicio Cántabro de Salud #### Lead Sponsor **Class:** OTHER **Name:** Universitat Autonoma de Barcelona #### Responsible Party **Investigator Affiliation:** Universitat Autonoma de Barcelona **Investigator Full Name:** Ana Barajas Velez **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this clinical trial is to compare the efficacy of combined REHACOP + MCT alone in persons with nonaffective psychotic disorder in terms of recovery. The main questions it aims to answer are: * Does combined REHACOP + MCT therapy increase the clinical recovery in persons with nonaffective psychotic disorder (compared to MCT alone)? * What is the impact of combined REHACOP + MCT therapy compared to MCT therapy alone on personal/psychological recovery, cognitive biases, and social cognition, taking gender differences into account? * What is the durability of the effects of combined REHACOP + MCT therapy compared to MCT therapy alone on clinical recovery, personal recovery, cognitive biases, and social cognition in the long term? Researchers will compare REHACOP+MCT therapy to MCT alone to see if there are differences in personal/psychological recovery. Participants will: * Participate in Metacognitive Training or in combined REHACOP + Metacognitive training therapy. * Do 8 weekly sessions of 45-60 minutes (MCT group). * Do 12 weekly sessions of 45-60 minutes (RECHACOP+MCT group). * Visit the clinic for checkups and tests. * Answer self-administered tests. **Detailed Description:** This project is aimed at responding to one of the Challenges of the Spanish Strategy for Science, Technology and Innovation, specifically Challenge 1: Health, demographic change and well-being. One of the work areas that are located within this challenge is the Clinical and Translational Research based on the evidence of scientific and technological knowledge.The present proposal is clearly within the framework of clinical-translational investigation, since most of the entities participating attend persons with psychotic disorders, thereby ensuring the translation of investigation to the clinical setting. In addition, this project includes investigators with wide experience in psychological interventions in the target population and with previous experience in investigation in this area. Lastly, it is of note that the benefits of this investigation are not only of a scientific nature but also involve clinical investigation with a direct repercussion on improvement in the health care of people with psychotic disorders, enabling the design of new strategies of psychological interventions. Besides, the present proposal is aimed at responding to the challenges of our society, contributing to covering the needs of persons with psychotic disorder as well as developing the most effective therapeutic strategies to improve aspects related to clinical and personal recovery. Specifically, this project will allow making changes that will improve the quality of health care to the target population incorporating the combinated use of scientifically proven therapeutic strategies to health care services. In short, this project aims to promote innovation in the provision of mental health services, being the starting point in analyzing the efficacy of combined psychological therapies versus monotherapies address to improve of metacognitive processes. - General and specific objectives. General objective: Compare the efficacy of combined REHACOP + MCT therapy vs. MCT alone in persons with nonaffective psychotic disorder in terms of recovery. Specific objectives: * Evaluate the effects of combined REHACOP + MCT therapy vs. MCT alone on clinical recovery (clinical remission and functional recovery, the latter understood in terms of cognitive, occupational and social functioning). * Evaluate the effects of combined REHACOP + MCT therapy vs. MCT alone on personal/psychological recovery. * Evaluate the effects of combined REHACOP + MCT therapy vs. MCT alone on cognitive biases and social cognition. * Evaluate the effects of combined REHACOP + MCT therapy vs. MCT alone according to gender. * Evaluate the effects of combined REHACOP + MCT therapy vs. MCT alone according to self-esteem, quality of life and stigma. * Evaluate the maintenance of the effects of combined REHACOP + MCT therapy vs. MCT alone on clinical recovery, personal recovery, cognitive biases and social cognition in the long term. * Methodology Design: This will be a randomised clinical trial in which one group will receive combined REHACOP + MCT therapy and another group will receive therapy with MCT alone. The metacognitive treatment will have the same characteristics in the two treatment conditions. Randomisation of the patients for receiving one of the two treatments will be carried out using a random number list based on the order of access to their reference centre. The evaluator will be blinded to the treatment group to which the patient assessed belongs. Study subjects: The sample will be made up of people with non-affective psychotic disorder who are attended in any of the centres participating in the study which belong to the following entities:Consorci Sanitari de Terrassa; Hospital de Mataró; Instituto de Investigación Biomédica de Gerona (IdIBG); Parc Sanitari Sant Joan de Déu; Asociación Centro de Higiene Mental Les Corts; Hospital Sierrallana-Tres Mares; and UGC Salud Mental de Jaén. Sample size: Considering that the investigators have no preliminary data on our principal objective in relation to clinical and personal recovery, the score obtained in the global assessment of functioning (GAF) at follow-up will be taken as a measure of outcome, since it is implicated in both clinical and functional recovery. The investigators used the data published in the article by Ochoa et al. (2017) in order to calculate the required sample size for this study. In this article, a difference of means of 5.73 points (SD=11.51) is obtained in the GAF scale from baseline and the follow-up at 6 months after the intervention. With these data, the necessary sample size has been estimated with an alpha of 0.05 and a power of 0.8. Taking into account 20% of possible losses to follow-up, the sample size has been calculated as 160 cases, 80 in each experimental arm (REHACOP + MCT vs. MCT). In this way, taking into account that the intervention groups will be carried out in the health care centers of 7 different entities each will have to recruit 24 patients, 12 for each experimental condition. Data collection: the professional who makes the referral of the patients to the study will be responsible for reviewing fulfillment of the inclusion and exclusion criteria. Patients fulfilling the inclusion criteria will receive an explanation of the study and if they accept to participate, they must provide signed informed consent. The evaluation will be carried out at 3 time points: T0 (basal assessment, prior to initiation of treatment). All the previously described scales will be administered; T1 (post-treatment evaluation), all the scales will be administered and, in addition, the satisfaction perceived with the interventions received will be evaluated; T2 (follow-up evaluation ) at 6 months after completing the intervention all the scales will again be administered. In addition, the number of relapses and hospitalizations during the time interval will be registered. Assessment of the PANSS and GAF should take into account the temporal criterium mentioned in the section of 'Outcomes'. A contingency plan will be considered in the event that difficulties are detected in carrying out any of the phases of the study due to external causes, such as the continuity of the COVID-19 pandemic. This plan will consist of the implementation of interventions and evaluations making use of new technologies. All the centers already have the adequate infrastructure to carry out the project under these conditions. Data analysis: Firstly, the two groups will be compared with the aim of verifying that there are no significant differences at baseline to confirm that they are comparable after randomization. Comparisons of means for independent samples will be carried out using the Student's t-test for continuous variables and the Chi-square test for categorical variables. The variables of the principal analysis will be the difference between the scores of the two groups (REHACOP+MCT and MCT) in the scores of the scales assessing clinical and personal/psychological recovery. The secondary results will be the differences in other assessments of social functioning, cognitive biases, and social cognition on comparing the two experimental conditions. Changes in the scores of these scales will be analyzed using regression methods for repeated measures, with the post-treatment score of the scales as the dependent variable and the basal score and the REHACOP+MCT group as the co-variables. Temporal stability of the results at 6 months will be assessed using the follow-up score as the dependent variable and evaluating how this affects the basal score, post treatment and the experimental condition. The statistical analyses will be performed according to intention to treat (ITT) without imputing the lost values. Gender, antipsychotic medication, and disease evolution time will be considered as control variables. Limitations: One of the limitations of this clinical trial might be the loss to follow-up. To compensate for these losses the sample size will be increased by 20%. It is expected that the losses to follow-up will be similar in the two groups. Otherwise, this variable will be considered as an indicator of the acceptability of treatment. - Ethical considerations: All the people who participate in the trial will sign the informed consent that takes into account the Declaration of Helsinki and the Organic Law 03/2018 of December 5. In the cases of minors informed consent will be signed by the legal guardians The project will be evaluated by each of the Ethics Committees of the participating centers. Participants will be informed that the data obtained will only be used for purposes related to the investigation and data confidentiality will be guaranteed according to the provisions of Organic Law 03/2018, of December 5 and Regulation (EU) 2016/679 of the European Parliament and of the Council, of April 27, 2016 and data protection (RGPD). The data management plan generated by the project, all information will be stored and managed in a secure and confidential manner, in accordance with the provisions of Organic Law 03/2018. In order to scrupulously respect the current legislation, the following measures will be taken: 1. Personal data will be pseudonymized. The identifying data are separated from the variables studied in the study. Therefore, a technical and functional separation will be made between the research team and those who perform the pseudonymization and retain the information that allows the reidentification of the participant. Pseudonymized data will only be accessible to the research team when: i) there is an express commitment to confidentiality and no re-identification activity, and ii) specific security measures are taken to prevent re-identification and access to unauthorized personal. 2. The person receiving the informed consent and custody will be different from the person who will process the data, or if this is not possible, the entire research team will sign an express commitment of confidentiality not to carry out re-identification activities. The signed informed consents will be kept under lock and key and out of the reach of the research team in a generic sense. ### Conditions Module **Conditions:** - Schizophrenia - Schizophreniform Disorders - Delusional Disorder - Brief Psychotic Disorder - Schizoaffective Disorder - Schizophrenia Spectrum and Other Psychotic Disorders **Keywords:** - Metacognitive Training - MCT - Cognitive Remediation - Psychotic disorder - Psychosis - Cognitive functions - Cognitive biases - Neurocognitive improvement ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This will be a randomized clinical trial in which one group will receive combined REHACOP + MCT therapy and another group will receive therapy with MCT alone. The metacognitive treatment will have the same characteristics in the two treatment conditions. Randomisation of the patients for receiving one of the two treatments will be carried out using a random number list based on the order of access to their reference centre. The evaluator will be blinded to the treatment group to which the patient assessed belongs. ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 160 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The participants will receive a combined therapy: Metacognitive Training (MCT) with Cognitive Remediation (CR). **Intervention Names:** - Behavioral: Cognitive Remediation (REHACOP) - Behavioral: Metacognitive Training (MCT) **Label:** REHACOP+MCT therapy **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The participants will receive Metacognitive Training (MCT) **Intervention Names:** - Behavioral: Metacognitive Training (MCT) **Label:** MCT alone **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - REHACOP+MCT therapy **Description:** REHACOP is a structured neuropsychological rehabilitation program that covers most of the cognitive deficits present in psychotic disorder: attention, learning and memory, executive functions, language, social cognition, daily life activities, social skills and psychoeducation. The modules of language, social cognition and psychoeducation will not be used in the present clinical trial. Each module includes a hierarchy of exercises based on the cognitive subarea to be worked on and the grade of difficulty demanded for the performance of each task.The format of the sessions will be the same as MCT, that is, groups of 6-10 patients who will receive weekly sessions of 45-60 minutes in length. In this case, the duration of the intervention will be 12 sessions. **Name:** Cognitive Remediation (REHACOP) **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - MCT alone - REHACOP+MCT therapy **Description:** The MCT consists in 8 weekly sessions of 45-60 minutes in length. Each group of patients should be made up of 6-10 patients. The material of the training program is available online at: http://www.uke.de/mkt. The material contains 16 powerpoint presentations (2 per each module), one manual and 6 pamphlets of tasks to do at home. The modules are as follows: Module 1: Attribution; Module 2: Jumping to conclusions (1st part); Module 3: Changing beliefs; Module 4: To emphatise (1st part); Module 5: Memory; Module 6: To emphatise (2nd part); Module 7: Jumping to conclusions (2nd part); and Module 8: Self-esteem and mood. **Name:** Metacognitive Training (MCT) **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Includes: a) CLINICAL REMISSION: based on the criteria of the Remission in Schizophrenia Working Group (RSWA) of Andreasen et al. (2005), which includes one criterium of severity measured with 7 items of the PANSS scale and one temporal criterium that requires the maintenance of the criterium of severity during 6 months or more; and b) FUNCTIONAL RECOVERY: based on the criteria defined by the German Research Network on Schizophrenia (GRNS group) (Schennach-Wolff et al., 2009), which includes one criterium of severity based on the GAF scale and one temporal criterium of maintaining the criterium of severity during 6 months or more. **Measure:** CLINICAL RECOVERY **Time Frame:** It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. **Description:** To be measured with the STORI test. **Measure:** FUNCTIONAL RECOVERY **Time Frame:** It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. #### Secondary Outcomes **Description:** A sociodemographic and clinical questionnaire created by the investigators of this study will be given with the aim of collecting the following data: age, gender, education, civil status, coexistence, current professional situation, total number of psychotic episodes, age at the first episode, substance use, type of treatments received (past and present), duration of untreated psychosis (DUP), relapses, number of hospitalisations, diagnosis according to the DSM-5, referral centre, family history, grade of satisfaction with care received, among others. **Measure:** Assesment instruments **Time Frame:** It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. **Description:** The facial emotion recognition test will be used (Baron-Cohen et al., 1997; Huerta-Ramos et al., 2017) constituted by 20 photographs expressing 10 basic and 10 complex emotions. **Measure:** Social Cognition. Recognition of emotion **Time Frame:** It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. **Description:** Includes different stories for evaluating the interpretation of social situations. **Measure:** Social Cognition. Hinting Task (Corcoran et al., 1995; Gil et al., 2012) **Time Frame:** It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. **Description:** The IPSAQ has 32 items which describe 16 positive and 16 negative social situations. For each situation the person must decide whether the cause is internal, personal or situational. **Measure:** Social Cognition. Internal, Personal and Situational Attributions Questionnaire (IPSAQ) (Kinderman & Bentall, 1996; Diez-Alegría, 2006) **Time Frame:** It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. **Description:** Jumping to conclusions (JTC) will be evaluated with the ball task. This is a task of probabilities in which the persons have to make a decision as to which box a ball belongs. The task will be used with a probability of 85%-15%, 60%-40% and with emotional tasks. JTC will be considered as making a decision after the extraction of one or two balls (Dudley et al., 2016). **Measure:** Ball task (Dudley et al.,1997). **Time Frame:** It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. **Description:** This questionnaire evaluates themost frequent cognitive biases in psychotic disorders. intentionality, catastrophism, dichotomic thinking, JTC and reasoning based on emotions. **Measure:** Cognitive Bias Questionnaire (CBQ) (Peters et al., 2013; Gutiérrez-Zotes, in press). **Time Frame:** It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. **Description:** This is a self applied questionnaire including 15 items which collect information on the capacity to correct erroneous judgements in two subscales: self-reflection and self-certainty. **Measure:** Beck Cognitive Insight Scale (BCIS) (Beck et al., 2004; Guitiérrez-Zotes et al., 2012). **Time Frame:** It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. **Description:** This scale was designed with the aim of evaluating areas of social functioning that are crucial for persons with schizophrenia to remain in the community. **Measure:** Social Functioning Scale (SFS) (Birchwood et al., 1990; Torres and Olivares, 2000). **Time Frame:** It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. **Description:** A battery of neuropsychological tests will be carried out to evaluate the domain of general cognitive functioning (Weschler Intelligence Scale \[WAIS\] (Weschler, 1999), to estimate the IQ using 4 subtests (vocabulary, similarities, block design and matrix reasoning), and specific domains of cognitive functioning. **Measure:** Cognitive functioning. **Time Frame:** It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. **Description:** This scale measures the general functioning of the patient on a scale from 0 to 100, with higher scores indicating better functioning. This scale can offer a score on clinical functioning (GAF-C) and another on social functioning (GAF-S). **Measure:** Global Assessment Functioning (GAF) (Endicott et al., 1976). **Time Frame:** It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. **Description:** The PANSS evaluates positive and negative symptoms and provides a score of general psychopathology. **Measure:** Positive and negative syndrome scale (PANSS) (Kay et al., 1987; Peralta and Cuesta, 1995). **Time Frame:** It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. **Description:** Attention **Measure:** Continuous Performance Test II (CPT-II) (Conners, 2000); Trail Making Test (TMT) (Reitan,1993). **Time Frame:** It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. **Description:** Learning and verbal memory **Measure:** Rey Auditory Verbal Learning Test (RAVLT) (Rey, 1964) **Time Frame:** It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. **Description:** Executive functions **Measure:** Wisconsin Card Sorting Test (WCST) (Bergs et al., 1948) **Time Frame:** It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. **Description:** Executive functions **Measure:** Trail Making Test (TMT-B) (Reitan, 1993) **Time Frame:** It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. **Description:** Executive functions **Measure:** Stroop Color and Word Test (Stroop, 1935) **Time Frame:** It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. **Description:** Processing Speed **Measure:** Trail Making Test (TMT-A) (Reintan, 1993) **Time Frame:** It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. **Description:** Processing Speed **Measure:** Controlled Oral Word Association Test (COWAT) (Benton&Hamsher, 1976) **Time Frame:** It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. **Description:** Processing Speed **Measure:** Letter-number sequencing (Wechsler Adult Intelligence Scale [WAIS]) (Weschler, 1999) **Time Frame:** It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. **Description:** Will be used to assess 4 components (search and maintain hope, reestablishment of positive identity, find the meaning of life and assume responsibility of one's own life) and 5 stages of the recovery process (moratorium, awareness, preparation, rebuilding and growth). This instrument is made up of 50 items which score in the Likert type scale from 0 to 5. The resulting scores represent the 5 phases of personal/psychological recovery. The scale showing the highest score indicates the stage of recovery in which the patient is at that time. **Measure:** The Stages of Recovery Instrument (STORI) (Andresen et al., 2006; Lemos et al., 2015) **Time Frame:** It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. **Description:** Quality of life **Measure:** WHO Quality of Life-BREF 26. (WHOQOL-BREF) (Üstun et al., 1988; Vázquez-Barquero et al., 2000). **Time Frame:** It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. **Description:** It's an instrument designed to assess functioning and disability in six main domains: cognition, mobility, self-care, interpersonal relationships, activities of daily living, and participation in society. **Measure:** World Health Organization Disability Assessment Schedule (WHO-DAS-II) (Üstun et al., 1988; Vázquez-Barquero et al., 2000) **Time Frame:** It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. **Description:** Stigma **Measure:** Internalized Stigma of Mental Illness Scale (ISMI) (Ritsher, Otilingama, Grajalesa, 2003) **Time Frame:** It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. **Description:** Self-esteem **Measure:** Rosenberg self-esteem scale (RSES) (Rosenberg et al., 1965; Atienza, Balaguer & Moreno, 2000) **Time Frame:** It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Presence of one of the e following diagnostics according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5): schizophrenia, schizophreniform disorder, delusional disorder, brief psychotic disorder, schizoaffective disorder, and non specified schizophrenia spectrum disorder and other psychotic disorders. * Be in a stable clinical phase (without psychiatric hospitalization in the last 3 months). * Have good adherence to pharmacological treatment. * T-score \< 40 in any cognitive outcome measured by TAVEC, CPT-IP, TMT, Stroop, WSCT, FAS and WAIS (Vocabulary, Digit Forward, Digit Backwards and Digit Symbol Coding. * Willing to participate in the study expressed by providing signed informed consent. Exclusion Criteria: * Presence of traumatic brain lesion, dementia or intellectual discapacity (IQ \<70). * Positive and Negative Syndrome Scale (PANSS) score \>= 5 in hostility and lack of cooperation and \>= 6 in suspiciousness. * Presence of an additional diagnosis of severe disorder related to substances. * Having participated in a CR and/or MCT intervention in the year prior to incorporation into the study. **Maximum Age:** 55 Years **Minimum Age:** 16 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ana Barajas Velez **Phone:** +34935814452 **Role:** CONTACT #### Locations **Location 1:** **City:** Cerdanyola Del Vallès **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ana Barajas Velez - **Phone:** +34935814452 - **Role:** CONTACT **Country:** Spain **Facility:** Universitat Autonoma de Barcelona **State:** Barcelona **Status:** RECRUITING **Zip:** 08193 #### Overall Officials **Official 1:** **Affiliation:** Universitat Autonoma de Barcelona **Name:** Ana Barajas Velez **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M15376 - Name: Schizophrenia - Relevance: HIGH - As Found: Schizophrenia - ID: M4815 - Name: Mental Disorders - Relevance: HIGH - As Found: Psychotic - ID: M14473 - Name: Psychotic Disorders - Relevance: HIGH - As Found: Psychotic Disorders - ID: M21838 - Name: Schizophrenia Spectrum and Other Psychotic Disorders - Relevance: HIGH - As Found: Schizophrenia Spectrum and Other Psychotic Disorders - ID: M6902 - Name: Delusions - Relevance: LOW - As Found: Unknown - ID: M15380 - Name: Schizophrenia, Paranoid - Relevance: HIGH - As Found: Delusional Disorder ### Condition Browse Module - Meshes - ID: D000012559 - Term: Schizophrenia - ID: D000001523 - Term: Mental Disorders - ID: D000011618 - Term: Psychotic Disorders - ID: D000019967 - Term: Schizophrenia Spectrum and Other Psychotic Disorders - ID: D000012563 - Term: Schizophrenia, Paranoid ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423638 **Acronym:** TCERN **Brief Title:** Feasibility of Virtual Tai Chi Easy for Registered Nurses **Official Title:** The Feasibility of Tai Chi Easy Training for Registered Nurses #### Organization Study ID Info **ID:** STUDY00003718 #### Organization **Class:** OTHER **Full Name:** University of Arizona ### Status Module #### Completion Date **Date:** 2024-07-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-15 **Type:** ESTIMATED #### Start Date **Date:** 2023-12-22 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Arizona #### Responsible Party **Investigator Affiliation:** University of Arizona **Investigator Full Name:** Carlie Felion **Investigator Title:** PI **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 will examine the feasibility of virtual Tai Chi Easy training for registered nurses and see if participation results in changes in symptoms of transition shock, healthcare-related psychological traumatic stress, burnout, somatic symptoms, and intention to quit. Participants will do virtual Tai Chi Easy for 2 hours per week and practice on their own for 40 minutes per week. The study will last six weeks. Surveys will be completed in REDCap before, during, and after the intervention. **Detailed Description:** Nurses are the backbone of the healthcare system, comprising 59% of the healthcare workforce (Salmond, 2021); however, research indicates that 32.8% of newly hired Registered Nurses (RNs) voluntarily terminate their positions within the first year and must then be replaced (NSI Nursing Services, 2023). The turnover problem among nurses threatens the delivery of adequate, safe, and timely patient care, the health and well-being of nurses and other healthcare professionals, and the sustainability of the organizations for which they work. High job turnover among nurses is a problem that has inspired the design, implementation, and study of numerous organization/system-driven interventions over at least the past sixty years. Numerous researchers have identified the first year of practice as the most stressful time in a nurse\&#39;s career (Chesak, 2019), with the highest levels occurring at four and eight months of employment (Fang, 2022). These nurses can experience a phenomenon known as \&#39;transition shock,\&#39; comprising cognitive, psychological, and emotional distress (Duchscher, 2009). Transition shock can lead to nurses feeling overwhelmed by the stark and unanticipated realities of nursing practice, especially if that reality conflicts with previously held ideals, beliefs, and expectations. In addition to experiencing elevated stress levels and transition shock, exposure to healthcare-related psychological trauma plays a key role in why nurses have left and continue to leave their positions and the profession in droves (Foli, 2019). Burnout is a common phenomenon among nurses. Key contributors to the development of burnout among healthcare workers include exposure to traumatic events such as witnessing death and suffering, the psychological and physical demands of the job, shift work, low autonomy, inadequate social support, incivility in the workplace, low staffing, and poor communication and collaborative relationships with other healthcare professionals (Chesak, 2019). Despite the significant human and financial resources invested in solutions that attempt to mitigate nurse turnover, there is surprisingly little evidence in the published literature on the use of integrative mind-body self-care interventions to help individual nurses cope with prolonged or toxic levels of stress, burnout, traumatic stress, and somatic symptoms. Self-care deficits are common among nurses, who typically focus on helping and serving others. While altruism, compassion, and a commitment to help others draw many people to a career in nursing, the desire to help others deal with their health problems can sometimes overshadow a nurse\&#39;s motivation or ability to care for themselves (Crane, 2016). A 2017 survey by the American Nurses Association (ANA, 2017) found that 68% of nurses put their patients' safety, health, and wellness ahead of their own. Furthermore, although nurses are well-educated and often teach patients about the importance of health-promoting behaviors, that knowledge does not always translate into engagement in healthy lifestyle behaviors among nurses themselves (Albert, 2014). In the wake of the COVID-19 pandemic, when nurses are more traumatized, stressed, and spread thinner than ever (American Nurses Foundation, 2021), some are resorting to employing maladaptive coping strategies, such as substance or alcohol abuse, to cope with stress and negative emotions (Foli, 2021). This highly problematic engagement in maladaptive coping strategies highlights and underscores the need for safe, cost-effective, accessible, and acceptable self-care options for nurses. Mind-body psychoneuroimmunology-based interventions, such as Tai Chi, have been used for centuries by people all over the world and may be a feasible self-care intervention for new graduate nurses. Mind-body therapies are defined as those that emphasize using the brain in conjunction with the body to harness innate healing powers. Mind-body exercise often includes multiple components, such as breathing practices, focused attention, meditation, and gentle physical movements (Bower, 2016). Numerous conceptual models propose that the primary mechanism by which mind-body therapies produce their effects is through self-regulation, which has a top-down effect on numerous physiological processes that impact health and health behaviors (Bower, 2016). Mind-body modalities can improve nurses\&#39; general health and well-being and may help prevent or reduce burnout by reducing psychological stress and alleviating somatic symptoms (Jung, 2021) through alterations in inflammatory processes (Irwin, 2015). Tai Chi Easy™ (TCE) is a safe, cost-effective, non-pharmacological intervention developed by Dr. Roger Jahnke. TCE is a simplified and streamlined practice that draws from the four main recognized styles of tai chi (Ward, 2023). According to Jahnke (2003), the deliberate attention to breathing, movement, and meditation in tai chi integrates the nervous, endocrine, cardiovascular, digestive, and immune systems with the psyche. TCE practice comprises four baskets: Self-applied massage, mindful movement, breathing exercises, and meditation exercises (Ward, 2023). TCE is appropriate for people of all ages and health conditions because it is easy to learn and perform and is extremely adaptable (Ward, 2023).TCE is a cost-effective and sustainable mind-body intervention that does not require any special clothing, footwear, or equipment and can be practiced virtually anywhere, at any time. Therefore, TCE is the ideal behavioral intervention for this study to help new nurses cope with stress and improve their overall health and well-being. Offering TCE in an asynchronous, virtual format will allow nurses (who often work the night shift and may need to sleep when in-person classes would typically be offered) to allow for greater flexibility and opportunities to access the intervention. The purpose of this study is to a) gain a deeper understanding of factors contributing to high turnover among nurses, including past exposure to adverse childhood experiences and adverse life events, b) determine whether virtual TCE training is a feasible, acceptable, safe, and appropriate mind-body self-care intervention among NGNs, and c) explore whether changes in stress, transition shock, posttraumatic stress symptoms, and transition shock occur after participation in a six-week asynchronous virtual TCE training intervention. The specific aims of this study are as follows: Aim 1: Feasibility - Evaluate whether Tai Chi Easy™ is a feasible, acceptable, and appropriate self-care intervention for registered nurses. Recruitment, retention, intervention adherence, and safety data will also be obtained. Aim 2: Changes in Symptoms of Distress - Explore whether changes in stress, transition shock, burnout, somatic symptoms, posttraumatic stress symptoms, and intention to quit occur post-intervention. The results of this study will 1) fill an important knowledge gap in the nursing literature, 2) inform future studies regarding the use of virtual Tai Chi Easy™ as a safe, acceptable, cost-effective, and sustainable intervention for nurses who may be experiencing the phenomena of interest, and 3) provide information with potential utility for the academic and healthcare industry sectors. There is a demonstrated need to better prepare nurses for the tumultuous and highly stressful entry to professional practice and to guide the design and implementation of programs to help new nurses adjust and remain in their roles. ### Conditions Module **Conditions:** - Transition Shock - Nurses' Intention to Quit - Stress - Somatic Symptoms - Burnout - Trauma and Stressor Related Disorders **Keywords:** - Tai Chi Easy - Healthcare-Related Psychological Trauma - Virtual - Transition Shock - burnout - nurse - somatic symptoms - stress ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will complete two 60 minute virtual Tai Chi Easy classes per week and practice on their own 10 minutes per day on 4 other days each week for six weeks. **Intervention Names:** - Behavioral: Virtual Tai Chi Easy **Label:** Intervention **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention **Description:** The TCE intervention will be delivered asynchronously online. Participants can complete the classes at a time and in a location that is convenient for them. The classes will be offered for one hour twice weekly and were developed and recorded by a certified Tai Chi Easy practice leader. TCE is a simple form of mind-body self-care that focuses on four components: * Mindful movements that help to stretch, and relax the body while improving balance and coordination * Breathing practices that reduce stress by inducing a relaxation response while improving energy and circulation and enhancing innate healing responses * Self-applied massage to stimulate blood flow, relax the body, and improve circulation and energy * Meditation practices to relax the body, center the mind, and calm the emotions **Name:** Virtual Tai Chi Easy **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Evaluating the feasibility, acceptability, and appropriateness of intervention, as well as recruitment and retention **Measure:** Feasibility of Virtual Tai Chi Easy training **Time Frame:** 8 weeks #### Secondary Outcomes **Description:** Changes in characteristics of transition shock post-intervention **Measure:** Transition Shock **Time Frame:** 8 weeks **Description:** Changes in burnout symptoms post intervention **Measure:** Burnout **Time Frame:** 8 weeks **Description:** Changes in somatic symptoms post intervention **Measure:** Somatic Symptoms **Time Frame:** 8 weeks **Description:** Changes in intention to quit post-intervention **Measure:** Intention to Quit **Time Frame:** 8 weeks **Description:** Changes in stress and post-traumatic stress symptoms post-intervention **Measure:** Stress and post-traumatic stress symptoms **Time Frame:** 8 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Registered Nurses from any racial/ethnic, socioeconomic group, sex/gender. Access to a computer, tablet, or smartphone Reliable internet access Ability to read and write in English Exclusion Criteria: Refusal to provide informed consent Regularly participating in Tai Chi or other mind-body exercise (as defined by participating more than once per week) Refusal or inability to fully participate in the study protocol Previously diagnosed post-traumatic stress disorder not due to a healthcare-related exposure event, active substance use disorder, or serious mental illness. An acute or chronic medical or mental health condition that would otherwise limit the person's ability to fully participate in study activities. **Healthy Volunteers:** True **Maximum Age:** 99 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Carlie Felion, PhDc **Phone:** (480) 749-4550 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Ruth Taylor-Piliae, PhD **Phone:** (520) 626-4881 **Role:** CONTACT #### Locations **Location 1:** **City:** Tucson **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Carlie Felion, PhDc - **Phone:** 480-749-4550 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Ruth Taylor-Piliae, PhD - **Phone:** (520) 626-4881 - **Role:** CONTACT **Country:** United States **Facility:** University of Arizona **State:** Arizona **Status:** RECRUITING **Zip:** 85721 #### Overall Officials **Official 1:** **Affiliation:** University of Arizona **Name:** Carlie M Felion **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** No plan to share data with other researchers **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013315 - Term: Stress, Psychological - ID: D000001526 - Term: Behavioral Symptoms - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M15577 - Name: Shock - Relevance: LOW - As Found: Unknown - ID: M222 - Name: Trauma and Stressor Related Disorders - Relevance: HIGH - As Found: Trauma and Stressor Related Disorders - ID: M885 - Name: Medically Unexplained Symptoms - Relevance: HIGH - As Found: Somatic Symptom - ID: M1658 - Name: Burnout, Psychological - Relevance: HIGH - As Found: Burnout - ID: M113 - Name: Psychological Trauma - Relevance: LOW - As Found: Unknown - ID: M16105 - Name: Stress, Psychological - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - 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: D000071896 - Term: Medically Unexplained Symptoms - ID: D000077062 - Term: Burnout, Psychological - ID: D000068099 - Term: Trauma and Stressor Related Disorders ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423625 **Acronym:** MIRON-PREDICT **Brief Title:** Hemorrhagic MI Prediction Score Model **Official Title:** Developing a Prediction Score Model for Predicting the Likelihood of Hemorrhagic MI Before Percutaneous Coronary Reperfusion Therapy #### Organization Study ID Info **ID:** 19978d #### Organization **Class:** OTHER **Full Name:** Indiana University ### Status Module #### Completion Date **Date:** 2024-03-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-03-31 **Type:** ACTUAL #### Start Date **Date:** 2023-06-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Rohan Dharmakumar #### Responsible Party **Investigator Affiliation:** Indiana University School of Medicine **Investigator Full Name:** Rohan Dharmakumar **Investigator Title:** Executive Director, Krannert Cardiovascular Research Center **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Developing a prediction score model for predicting the likelihood of Hemorrhagic MI ### Conditions Module **Conditions:** - Acute Myocardial Infarction **Keywords:** - Acute Myocardial Infarction - Prediction Score - Machine Learning - Hemorrhagic MI ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 1100 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Percentage of MI patients confirmed as Hemorrhagic MI **Measure:** Hemorrhagic MI **Time Frame:** Emergency admission to Percutaneous Intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age \> 18 yrs * Index MI * Primary PCI Exclusion Criteria: * History of prior myocardial infarction, * Thrombolysis before PCI * Contraindication to Cardiac MRI **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study population consists of individuals aged 18 - 80 yrs who have been diagnosed with acute ST-elevation myocardial infarction (STEMI) and are scheduled for emergency percutaneous coronary intervention (PCI). ### Contacts Locations Module #### Locations **Location 1:** **City:** Indianapolis **Country:** United States **Facility:** Krannert Cardiovascular Research Center, Indiana University School of Medicine **State:** Indiana **Zip:** 46202 #### Overall Officials **Official 1:** **Affiliation:** Indiana University School of Medicine, Krannert Cardiovascular Research Center **Name:** Keyur P Vora, MD FACC **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007511 - Term: Ischemia - ID: D000010335 - Term: Pathologic Processes - ID: D000009336 - Term: Necrosis - ID: D000017202 - Term: Myocardial Ischemia - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000014652 - Term: Vascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12155 - Name: Myocardial Infarction - Relevance: HIGH - As Found: Myocardial Infarction - ID: M10282 - Name: Infarction - Relevance: HIGH - As Found: Infarction - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M12284 - Name: Necrosis - Relevance: LOW - As Found: Unknown - ID: M6546 - Name: Coronary Artery Disease - Relevance: LOW - As Found: Unknown - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009203 - Term: Myocardial Infarction - ID: D000007238 - Term: Infarction ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423612 **Acronym:** ROVING-PUMA **Brief Title:** Randomized Trial to Optimize Virologic Suppression Rates Using a Point-of-Care Urine Monitoring Assay (ROVING PUMA) **Official Title:** Randomized Trial to Optimize Virologic Suppression Rates Using a Point-of-Care Urine Monitoring Assay (ROVING PUMA) #### Organization Study ID Info **ID:** A143057 #### Organization **Class:** OTHER **Full Name:** University of California, San Francisco #### Secondary ID Infos **ID:** R01AI143340-06 **Link:** https://reporter.nih.gov/quickSearch/R01AI143340-06 **Type:** NIH ### Status Module #### Completion Date **Date:** 2029-08-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2029-08-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Desmond Tutu HIV Foundation **Class:** OTHER **Name:** University of Cape Town **Class:** NIH **Name:** National Institute of Allergy and Infectious Diseases (NIAID) #### Lead Sponsor **Class:** OTHER **Name:** University of California, San Francisco #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Antiretroviral therapy (ART) has significantly decreased the morbidity and mortality of HIV infection. However, adherence challenges in taking daily oral ART persist. A retrospective cohort study across 31 countries from 2010-19 reported that only 65% of people with HIV (PWH) on ART exhibited virologic suppression (VS) three years after starting ART;1 the rate of VS in South Africa among PWH on ART is 60-65%. Adherence barriers span individual and structural factors, such as stigma, recall difficulties, housing and/or food insecurity, mental illness, substance use, transportation, stock-outs, and other factors that vary by country and population. Adherence interventions can benefit from direct objective adherence monitoring. Pharmacologic metrics of adherence assess drug levels in plasma, dried blood spots, hair (a metric our group pioneered) or urine and predict outcomes more accurately than self-reported adherence. However, most of these metrics preclude real-time assessment, requiring expensive laboratory equipment and trained laboratory personnel. Thus, few adherence interventions have successfully incorporated objective metrics, likely due to laboratory and shipping delays. A low-cost (\<$2/test) point-of-care adherence metric - developed by our group - should allow for real-time biofeedback and improve the impact of metric-driven adherence interventions. **Detailed Description:** This is a randomized hybrid type 1 effectiveness study design to assess the factors related to implementation of a point-of-care urine TFV assay test into routine HIV clinical care. We plan to recruit a total of 500 adults living with HIV who received primary HIV care from one of the selected study clinics in BCM, Eastern Cape. Individuals who have been prescribed ART for at least 6 months who have not achieved VS will be randomized in a 1:1 fashion at the baseline visit to the intervention arm vs. the SoC arm. Total duration of the study is 18 months from the time of enrollment. ### Conditions Module **Conditions:** - ART Adherence **Keywords:** - ART - Adherence - South Africa - Viral Suppression - ART resistance - POC urine assay - TDF assay ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized hybrid type 1 effectiveness trial ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Conduct enhanced ART adherence counselling informed by the results of the point-of-care urine assay for TFV to increase viral suppression. **Intervention Names:** - Behavioral: POC urine assay informed enhanced ART adherence counselling for viral suppression **Label:** POC Urine Test Informed ART Adherence Counselling **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Follow South Africa's standard-of-care enhanced ART adherence counselling for viral suppression. **Label:** Standard-of-care Enhanced Adherence Counselling **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - POC Urine Test Informed ART Adherence Counselling **Description:** Collect urine on intervention participants and screen for presence of TFV. Feedback will be provided to the participant based on the results on their ART adherence with provision of enhanced ART adherence counseling for viral suppression. **Name:** POC urine assay informed enhanced ART adherence counselling for viral suppression **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The primary outcome of effectiveness will be viral suppression at 6 months. **Measure:** Viral Suppression at 6 months **Time Frame:** 18 months #### Secondary Outcomes **Description:** Durability of the 6-month intervention on viral suppression at 9, 12, and 18months **Measure:** Viral suppression at 9, 12, and 18months **Time Frame:** 18 months **Description:** The effect of the intervention on need for resistance testing and genotype results @ 6 and 18 months **Measure:** Resistance testing and genotype results @ 6 and 18 months **Time Frame:** 18 months **Description:** Assess the feasibility and acceptability of the intervention using a survey and in-depth interviews **Measure:** Feasibility and Acceptability of the intervention **Time Frame:** 18 months **Description:** Assess the cost per patient, cost per additional patient with VS, and cost per disability-adjusted life-year averted from a society perspective with using the urine-based TFV adherence assay to inform adherence counseling vs. standard of care counseling. **Measure:** Cost-effectiveness of the intervention **Time Frame:** 18 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Aim 1: Individuals ≥16 years of age at the initial screening visit living with HIV, prescribed ART for at least three months, and are not virally suppressed. Aim 2: Same as Aim 1 for the acceptability survey and in-depth interviews. HIV care providers in the selected clinic sites for the feasibility survey and in-depth interviews. Aim 3: Same as Aim 1 for the cost-effectiveness study. Exclusion Criteria: * Currently enrolled in another ART adherence intervention * Patients on ART regimen that does not include Tenofovir * HIV care providers from non-study sites Failure to provide written consent **Healthy Volunteers:** True **Minimum Age:** 16 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Monica Gandhi **Phone:** 415 476 4082 **Phone Ext:** 127 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Purba Chatterjee **Role:** CONTACT #### Locations **Location 1:** **City:** East London **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Sammy Nena - **Phone:** +27715153785 - **Role:** CONTACT ***Contact 2:*** - **Name:** Andrew Marino, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** South Africa **Facility:** Desmond Tutu HIV Foundation #### Overall Officials **Official 1:** **Affiliation:** University of California, San Francisco **Name:** Monica Gandhi **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Investigators conducting ART adherence research. **Description:** We will share de-identified data in publicly accessible databases once study is complete and study findings disseminated. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** 48 months from start of study ### References Module #### References **Citation:** Niu X, Kubiak RW, Siriprakaisil O, Klinbuyaem V, Sukrakanchana PO, Cressey R, Okochi H, Gandhi M, Cressey TR, Drain PK. Tenofovir-Diphosphate in Dried Blood Spots vs Tenofovir in Urine/Plasma for Oral Preexposure Prophylaxis Adherence Monitoring. Open Forum Infect Dis. 2022 Aug 10;9(8):ofac405. doi: 10.1093/ofid/ofac405. eCollection 2022 Aug. **PMID:** 36004315 **Citation:** Spinelli MA, Haberer JE, Chai PR, Castillo-Mancilla J, Anderson PL, Gandhi M. Approaches to Objectively Measure Antiretroviral Medication Adherence and Drive Adherence Interventions. Curr HIV/AIDS Rep. 2020 Aug;17(4):301-314. doi: 10.1007/s11904-020-00502-5. **PMID:** 32424549 **Citation:** Gandhi M, Wang G, King R, Rodrigues WC, Vincent M, Glidden DV, Cressey TR, Bacchetti P, Spinelli MA, Okochi H, Siriprakaisil O, Klinbuayaem V, Mugo NR, Ngure K, Drain PK, Baeten JM. Development and validation of the first point-of-care assay to objectively monitor adherence to HIV treatment and prevention in real-time in routine settings. AIDS. 2020 Feb 1;34(2):255-260. doi: 10.1097/QAD.0000000000002395. **PMID:** 31634188 **Citation:** Cressey TR, Siriprakaisil O, Kubiak RW, Klinbuayaem V, Sukrakanchana PO, Quame-Amaglo J, Okochi H, Tawon Y, Cressey R, Baeten JM, Gandhi M, Drain PK. Plasma pharmacokinetics and urinary excretion of tenofovir following cessation in adults with controlled levels of adherence to tenofovir disoproxil fumarate. Int J Infect Dis. 2020 Aug;97:365-370. doi: 10.1016/j.ijid.2020.06.037. Epub 2020 Jun 14. **PMID:** 32553717 **Citation:** Drain PK, Bardon AR, Simoni JM, Cressey TR, Anderson P, Sevenler D, Olanrewaju AO, Gandhi M, Celum C. Point-of-care and Near Real-time Testing for Antiretroviral Adherence Monitoring to HIV Treatment and Prevention. Curr HIV/AIDS Rep. 2020 Oct;17(5):487-498. doi: 10.1007/s11904-020-00512-3. **PMID:** 32627120 **Citation:** Drain P, Ngure K, Mugo N, Spinelli M, Chatterjee P, Bacchetti P, Glidden D, Baeten J, Gandhi M. Testing a Real-Time Tenofovir Urine Adherence Assay for Monitoring and Providing Feedback to Preexposure Prophylaxis in Kenya (PUMA): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2020 Apr 2;9(4):e15029. doi: 10.2196/15029. **PMID:** 32238341 ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423599 **Acronym:** FIT-HF **Brief Title:** Effect of Weight Loss on Physical and Cardiac Performance in People With Obesity and Heart Failure **Official Title:** Effect of Weight Loss on Physical and Cardiac Performance in People With Obesity and Heart Failure #### Organization Study ID Info **ID:** U1111-1298-6418 #### Organization **Class:** OTHER **Full Name:** Hvidovre University Hospital #### Secondary ID Infos **ID:** 2023-503753-35-01 **Type:** CTIS ### Status Module #### Completion Date **Date:** 2026-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-17 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Jens D Hove, MD,PHD #### Responsible Party **Investigator Affiliation:** Hvidovre University Hospital **Investigator Full Name:** Jens D Hove, MD,PHD **Investigator Title:** Chief Physician, Research associate Professor, MD, PhD **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The benefit of weight loss in patients with obesity and heart failure with reduced ejection fraction (HFrEF) is controversial. Semaglutide has shown cardiovascular (CV) risk-reduction and impact on CV risk factors including overweight, dysglycaemia and hypertension in subjects with type 2 diabetes (T2D). The STEP-HFpEF (Semaglutide Treatment Effect in People With Obesity and HFpEF) recently demonstrated, at 1-year, to not only reduce weight considerably, but also significantly improve health-related quality of life, functional status scores and 6-min walk distance in patients with heart failure with preserved ejection fraction (HFpEF). Also, the recently concluded SELECT trial was the first CV outcome trial with semaglutide in patients with overweight or obesity and established CV disease, including heart failure (but no T2D). Semaglutide demonstrated a 20% reduction in MACE, defined as the composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. These landmark findings have important implications for clinicians -as they mean that weight loss and/or semaglutide as anti-obesity pharmacotherapy could be a treatment strategy for secondary prevention of CV disease in patients with overweight or obesity. It is, however, unknown whether weight loss with either calorie-restricted diet or semaglutide has beneficial effects in obese subjects with heart failure and reduced ejection fraction. Also it is unclear whether semaglutide has cardiovascular benefits irrespective of starting weight and amount of weight loss. Purpose: The study aims to investigate whether weight loss treatment with semaglutide is superior to weight loss with calorie-restricted diet in improving peak oxygen uptake in patients with obesity and heart failure with reduced ejection fraction. **Detailed Description:** Background: The prevalence of overweight and obesity has reached pandemic proportions. Obesity is known to increase the risk for Type 2 diabetes and hypertension, as well as the risk for overt cardiovascular (CV) disease, including myocardial infarction, heart failure, and stroke. The rising prevalence of obesity may counteract the recent advances in primary and secondary prevention of CV disease. Overweight and obesity are common in patients with CV disease; however, cardiologists face several challenges in managing body weight in this population. Many may not consider obesity as a therapeutic target probably because there were no previous highly effective and safe pharmacologic interventions to consider. In addition, they may not have the expertise or resources to implement lifestyle interventions and may have limited familiarity with obesity pharmacotherapy. Moreover, the long-term CV effects of obesity pharmacotherapy remain uncertain due to limited CV outcome data with weight loss as the primary intervention. Although current CV guidelines recognize the importance of weight loss, they primarily focus on lifestyle modifications, with fewer details on strategies to utilize obesity pharmacotherapy and surgery. However, the recent 2022 American Diabetes Association/European Association for the Study of Diabetes consensus on the management of Type 2 diabetes has moved up weight management to the front of the treatment algorithm, by prioritizing the use of pharmacologic interventions such as glucagon-like peptide-1 receptor agonists and dual glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 receptor agonists, which have potent weight-lowering effects, in addition to glucose-lowering effects. Hypothesis: The investigators hypothesise that weight loss treatment with semaglutide is superior to weight loss with state-of-the-art calorie-restricted diet in improving the peak oxygen uptake (ml/min/kg) after 52 weeks as a marker of physical performance (and with prognostic implications) in patients with obesity and heart failure with reduced ejection fraction. Design: This is a investigator-initiated, parallel-group, 2-arm assessor-blinded, open-label, randomised, controlled trial (RCT) comparing the effect of weight loss using low-calorie replacement diet to weight loss using semaglutide in obese patients with heart failure with reduced ejection fraction. Subjects will be randomised in a 1:1 ratio to receive either low-calorie replacement diet or semaglutide.The subjects wil be followed for 52 weeks during the intervention period. The patients will be examined at 16 weeks (where the weight loss is anticipated to be approximately equal in the two groups) and after 52 weeks. Primary, secondary and exploratory objectives are listed below. The exploratory objectives are mostly embedded mechanistic studies of an exploratory nature and therefore hypothesis-generating in the RCT. Intervention: Subjects will be treated with semaglutide once weekly or a weight loss intervention consisting of a calorie-restricted diet and dietary advice on top of standard of care, which covers management of heart failure medication, CV risk factors and healthy lifestyle counselling. ### Conditions Module **Conditions:** - Heart Failure With Reduced Ejection Fraction - Obesity - Weight Loss - Chronic Heart Failure ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This is a investigator-initiated, parallel-group, 2-arm assessor-blinded, open-label, randomised, clinical trial ##### Masking Info **Masking:** SINGLE **Masking Description:** Anonymized data will be analyzed **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Dose-escalation of semaglutide will take place during the first 16 weeks after randomisation (week 0). Patients will start at the 0.25 mg once-weekly dose and follow dose-escalation schedule (0.25, 0.5, 1.0, 1.7 and 2.4 mg). For all subjects we aim at reaching the recommended target dose of 2.4 mg semaglutide once weekly for the rest of the period of total 52 weeks. **Intervention Names:** - Drug: Semaglutide Injectable Product **Label:** Semaglutide intervention group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** In short, the weight loss program in the calorie-restricted diet group consists of 3 phases after randomisation (week 0). An initial weight loss phase of 8 weeks with 800 calories/day, a food re-introduction phase for 8 weeks and a weight loss maintenance phase for the rest of the period of total 52 weeks. **Intervention Names:** - Dietary Supplement: Calorie-restricted diet **Label:** Calorie-restricted diet intervention group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Semaglutide intervention group **Description:** Weight loss using Semaglutide **Name:** Semaglutide Injectable Product **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Calorie-restricted diet intervention group **Description:** Weight loss by calorie-restricted diet program followed by a weight loss maintenance follow-up program **Name:** Calorie-restricted diet **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Other Outcomes **Measure:** Composite endpoint consisting of all-cause death, non-fatal myocardial infarction, non-fatal stroke, heart failure hospitalisation or urgent heart failure visit **Time Frame:** Follow-up at 52 weeks **Measure:** First occurrence of a composite heart failure endpoint consisting of: heart failure hospitalisation, urgent heart failure visit, ischemic events or CV death **Time Frame:** Follow-up at 52 weeks **Measure:** All-cause death **Time Frame:** Follow-up at 52 weeks **Measure:** Total number of hospitalised days **Time Frame:** Follow-up at 52 weeks **Measure:** Total number of hospitalisations **Time Frame:** Follow-up at 52 weeks **Measure:** Total number of Serious Adverse Events (SAEs) **Time Frame:** Follow-up at 52 weeks **Measure:** Change in heart failure medication **Time Frame:** Follow-up at 52 weeks **Description:** To examine the effect of a weight loss with either calorie-restricted diet or semaglutide on quality of life in patients with obesity and heart failure with reduced EF **Measure:** EuroQol five dimensions five level (EQ-5D-5L) questionnaire **Time Frame:** The patients will answer a questionnaire after 0, 16 and 52 weeks **Measure:** Effects of weight loss with either treatment on cardiac metabolism, fibrosis, inflammation, and diastolic function by Cardiac MRI and Cardiac Rubidium-PET **Time Frame:** The patients will be examined after 0, 16 and 52 weeks **Description:** Analysis of: Blood samples, pulmonary function test and body composition scan (DEXA) **Measure:** Potentially favorable changes in other organ systems caused by weight loss in this patient group **Time Frame:** The patients will be examined after 0, 16 and 52 weeks **Measure:** Feasibility and safety of two modern weight loss programs for aggressive weight lowering in patients with heart failure with reduced ejection fraction. **Time Frame:** Follow-up at 52 weeks **Measure:** Changes in systolic and diastolic function and cardiac morphology assessed by echocardiography **Time Frame:** The patients will be examined after 0, 16 and 52 weeks #### Primary Outcomes **Description:** To examine the effect of weight loss on mean change in peak oxygen uptake at 52 weeks between semaglutide and calorie-restricted group compared to baseline (Measured in ml O2/(kg x min)) **Measure:** Peak oxygen uptake **Time Frame:** The patients will be examined after 0, 16 and 52 weeks #### Secondary Outcomes **Description:** To compare the effect of weight loss on the mean change **Measure:** The Clinical Summary Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-CSS) **Time Frame:** The patients will be examined after 0, 16 and 52 weeks. **Description:** To compare the effect of weight loss on the mean change **Measure:** 6-min walk distance (6MWD) **Time Frame:** The patients will be examined after 0, 16 and 52 weeks **Description:** To compare the effect of weight loss on the mean change **Measure:** End-systolic volume of the left ventricle assessed by Cardiac MRI **Time Frame:** The patients will be examined after 0, 16 and 52 weeks **Description:** To compare the effect of weight loss on the mean change **Measure:** N-terminal pro-B-type natriuretic peptide (NT-proBNP) and C-reactive protein (CRP) change **Time Frame:** The patients will be examined after 0, 16 and 52 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or female, age ≥ 18 years at the time of signing informed consent * Body mass index (BMI) ≥ 30 kg/m2 * Heart failure with New York Heart Association (NYHA)-class 1-3 and reduced ejection fraction (EF≤40%) established by either: 1. echocardiography AND/OR 2. cardiac magnetic resonance * On stable optimal medical heart failure therapy for at least 4 weeks Exclusion Criteria: 1. Cardiovascular-related: * Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 6 months prior to the day of screening * Planned coronary, carotid or peripheral artery revascularisation known on the day of screening * Transient heart failure related to reversible mechanisms like tachycardia, sepsis, etc. 2. Glycaemia-related: * Type 1 diabetes * Treatment with any Glucagon-Like Peptide-1 (GLP-1) agonists within 90 days prior to the day of screening * Type 2 diabetes requiring other pharmacotherapy than metformin and Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors 3. General safety: * Pregnancy or planned pregnancy * History or presence of chronic pancreatitis * Presence of acute pancreatitis within the past 180 days prior to the day of screening * Kidney disease with eGFR \< 35ml/min * Presence or history of malignant neoplasms within the past 5 years prior to the day of screening (Basal and squamous cell skin cancer and any carcinoma in-situ are allowed) * Known or suspected hypersensitivity to trial product(s) or related products **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jens D Hove, MD, PhD **Phone:** +4538623218 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Mohammed El-Sheikh, MD **Phone:** +4552309685 **Role:** CONTACT #### Locations **Location 1:** **City:** Copenhagen **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jens D Hove, MD, PhD - **Phone:** +4538623218 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Mohammed El-Sheikh, MD - **Phone:** +4552309685 - **Role:** CONTACT **Country:** Denmark **Facility:** Amager and Hvidovre Hospital University of Copenhagen **Status:** RECRUITING **Zip:** DK-2650 #### Overall Officials **Official 1:** **Affiliation:** Amager-Hvidovre Universitetshospital **Name:** Jens D Hove **Role:** PRINCIPAL_INVESTIGATOR ### 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: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000001836 - Term: Body Weight Changes ### 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: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5114 - Name: Body Weight - Relevance: HIGH - As Found: Weight - ID: M9421 - Name: Heart Failure - Relevance: HIGH - As Found: Heart Failure - ID: M12701 - Name: Obesity - Relevance: HIGH - As Found: Obesity - ID: M18102 - Name: Weight Loss - Relevance: HIGH - As Found: Weight Loss - 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: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M5115 - Name: Body Weight Changes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006333 - Term: Heart Failure - ID: D000009765 - Term: Obesity - ID: D000001835 - Term: Body Weight - ID: D000015431 - Term: Weight Loss ### 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 ### 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: M353561 - Name: Semaglutide - Relevance: HIGH - As Found: Carbohydrate - 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 ### Intervention Browse Module - Meshes - ID: C000591245 - Term: Semaglutide ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423586 **Brief Title:** Effect of Lecithin-based Curcuma and Boswellia on Post-acute COVID-19 IBS **Official Title:** Positive Effect of Lecithin-based Delivery Form of Curcuma and Boswellia Extracts on Post-acute COVID-19 Irritable Bowel Syndrome. Two Cohorts of an Open-label Study. #### Organization Study ID Info **ID:** 0912/09052020 #### Organization **Class:** OTHER **Full Name:** Azienda di Servizi alla Persona di Pavia ### Status Module #### Completion Date **Date:** 2022-06-10 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-10-01 **Type:** ACTUAL #### Start Date **Date:** 2021-09-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Azienda di Servizi alla Persona di Pavia #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This open-label study investigates the effects of lecithin-based formulations of Curcuma longa (Meriva™) and Boswellia serrata (Casperome™) extracts on post-acute COVID-19 irritable bowel syndrome (PCIBS) and irritable bowel syndrome (IBS) without prior COVID-19 infection. A total of 44 participants, 16 with PCIBS and 28 controls with IBS, were supplemented for 30 days. Outcomes measured included abdominal bloating, abdominal pain, enteral dysbiosis, and global assessment of efficacy. The study found significant reductions in bloating and pain in both groups, with a notable decrease in dysbiosis only in the IBS group. This suggests potential benefits of the supplementation in managing gastrointestinal symptoms associated with PCIBS and IBS. **Detailed Description:** This study aims to evaluate the efficacy and safety of lecithin-based formulations of Curcuma longa (Meriva™) and Boswellia serrata (Casperome™) extracts in treating gastrointestinal symptoms in patients with post-acute COVID-19 irritable bowel syndrome (PCIBS) and irritable bowel syndrome (IBS) without prior COVID-19 infection. The study was conducted at the Department of Public Health of the University of Pavia, Italy. Participants included 16 PCIBS patients and 28 IBS controls, aged 18-75 years. They were administered 500 mg of Curcuma longa and 150 mg of Boswellia serrata extracts twice daily for 30 days, in conjunction with a low FODMAP diet. Key outcomes measured were reductions in abdominal bloating and pain, changes in enteral dysbiosis as indicated by urinary indican levels, and overall treatment efficacy as assessed by participants. The study found that both groups experienced significant reductions in abdominal bloating and pain. However, a notable decrease in enteral dysbiosis was observed only in the IBS control group. The treatment was well tolerated with no reported adverse effects. These findings suggest that the combination of Curcuma longa and Boswellia serrata extracts may provide significant benefits in managing gastrointestinal symptoms associated with PCIBS and IBS. ### Conditions Module **Conditions:** - Post-Acute COVID-19 Syndrome - Irritable Bowel Syndrome - Abdominal Pain - Dysbiosis **Keywords:** - abdominal pain - Bloating - Boswellia serrata - Covid-19 infection - Curcuma longa - Dysbiosis - IBS (irritable bowel syndrome) - Long Covid ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 44 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants with post-acute COVID-19 irritable bowel syndrome (PCIBS) supplemented with lecithin-based formulations of Curcuma longa (Meriva™) and Boswellia serrata (Casperome™) extracts. **Intervention Names:** - Dietary Supplement: Curcuma longa and Boswellia serrata extracts **Label:** PCIBS Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants with irritable bowel syndrome (IBS) without prior COVID-19 infection supplemented with lecithin-based formulations of Curcuma longa (Meriva™) and Boswellia serrata (Casperome™) extracts. **Intervention Names:** - Dietary Supplement: Curcuma longa and Boswellia serrata extracts **Label:** IBS Control Group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - IBS Control Group - PCIBS Group **Description:** Participants received 500 mg of Curcuma longa and 150 mg of Boswellia serrata extracts (Meriva™ and Casperome™) twice daily for 30 days. **Name:** Curcuma longa and Boswellia serrata extracts **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Other Outcomes **Description:** Assess the overall efficacy of the treatment using a 4-point scale (ineffective, moderately effective, effective, very effective). **Measure:** Global Assessment of Efficacy (GAE) **Time Frame:** 30 days #### Primary Outcomes **Description:** Measure the change in abdominal bloating severity from baseline to the end of the study using a validated questionnaire. **Measure:** Reduction in Abdominal Bloating **Time Frame:** 30 days #### Secondary Outcomes **Description:** Evaluate the change in urinary indican levels from baseline to the end of the study to assess enteral dysbiosis **Measure:** Change in Urinary Indican Levels **Time Frame:** 30 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age: 18-75 years, male or female. * Diagnosis of post-acute COVID-19 irritable bowel syndrome (PCIBS) 60-120 days after the end of infection. * Diagnosis of irritable bowel syndrome (IBS) without prior COVID-19 infection. * Evidence of functional abdominal bloating/distention (FAB/D) type of IBS according to Mearin et al. * Presence of enteral dysbiosis defined by increased urinary indican values with normal skatole urinary concentration. Exclusion Criteria: * Normal urinary indican values or increased urinary skatole values. * Subjects already on a low FODMAP diet or other dietary restrictions such as gluten-free diet or lactose-free diet within the past 6 months. * Allergies to soy, nuts, or seafood, or insulin-dependent diabetes. * Known history of celiac disease, symptomatic diverticular disease, inflammatory bowel disease, or microscopic colitis. * Prior small bowel or colonic surgery or cholecystectomy. * Presence of bloody diarrhea or severe vomiting. * Severe renal disease (serum creatinine \>1.5 mg/dL) or liver disease (altered liver function tests). **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Pavia **Country:** Italy **Facility:** Mariangela Rondanelli **State:** PV **Zip:** 27100 #### Overall Officials **Official 1:** **Affiliation:** Italian Diagnostic Center (CDI) **Name:** Giacosa Attilio **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000011024 - Term: Pneumonia, Viral - ID: D000011014 - Term: Pneumonia - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000014777 - Term: Virus Diseases - ID: D000018352 - Term: Coronavirus Infections - ID: D000003333 - Term: Coronaviridae Infections - ID: D000030341 - Term: Nidovirales Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000003109 - Term: Colonic Diseases, Functional - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations - ID: D000012817 - Term: Signs and Symptoms, Digestive - ID: D000094025 - Term: Post-Infectious Disorders - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes ### 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: BC06 - Name: Digestive System Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - 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: M3013 - Name: Post-Acute COVID-19 Syndrome - Relevance: HIGH - As Found: Post-Acute COVID-19 Syndrome - ID: M25118 - Name: Irritable Bowel Syndrome - Relevance: HIGH - As Found: Irritable Bowel Syndrome - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M18311 - Name: Abdominal Pain - Relevance: HIGH - As Found: Abdominal Pain - ID: M30405 - Name: Dysbiosis - Relevance: HIGH - As Found: Dysbiosis - 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: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M6337 - Name: Colonic Diseases, Functional - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M15622 - Name: Signs and Symptoms, Digestive - Relevance: LOW - As Found: Unknown - ID: M3014 - Name: Post-Infectious Disorders - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000086382 - Term: COVID-19 - ID: D000094024 - Term: Post-Acute COVID-19 Syndrome - ID: D000043183 - Term: Irritable Bowel Syndrome - ID: D000013577 - Term: Syndrome - ID: D000015746 - Term: Abdominal Pain - ID: D000064806 - Term: Dysbiosis ### Intervention Browse Module - Ancestors - ID: D000000975 - Term: Antioxidants - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000020011 - Term: Protective Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: HB - Name: Herbal and Botanical - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M342247 - Name: Turmeric extract - Relevance: HIGH - As Found: Dental prostheses - ID: M4292 - Name: Antioxidants - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown - ID: T319 - Name: Turmeric - Relevance: HIGH - As Found: Dental prostheses - ID: T198 - Name: Indian Frankincense - Relevance: HIGH - As Found: Long-term memory - ID: T404 - Name: Lecithin - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000012596 - Term: Turmeric extract ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423573 **Acronym:** FOSteR **Brief Title:** A Study to Assess the Incidence of Skin Cancers in Patients With Epidermolysis Bullosa Receiving Filsuvez **Official Title:** A Long-term Non-interventional Study to Assess the Incidence of Skin Malignancies in Patients With Dystrophic and Junctional Epidermolysis Bullosa Receiving Treatment With Filsuvez #### Organization Study ID Info **ID:** AEB-21 #### Organization **Class:** INDUSTRY **Full Name:** Amryt Pharma ### Status Module #### Completion Date **Date:** 2032-08-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2031-11-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-11-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Chiesi Farmaceutici S.p.A. #### Lead Sponsor **Class:** INDUSTRY **Name:** Amryt Pharma #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** In patients with epidermolysis bullosa (EB), collagen does not form properly, so their skin is very fragile and blisters easily. Such patients are also at greatly increased risk of developing skin cancers. Filsuvez is a topical gel used to promote healing of skin lesions in patients with certain types of EB. In this observational study, patients with either dystrophic EB (DEB) or junctional EB (JEB) will receive standard of care treatment, whether Filsuvez or something else, and will be followed for up to 5 years. The main purpose is to see if the use of Filsuvez affects the likelihood of developing skin malignancies in these patient populations. **Detailed Description:** Some forms of EB are associated with a greatly increased incidence of aggressive skin and mucosal squamous cell carcinoma (SCC), as well as increased incidence of other skin malignancies including basal cell carcinoma (BCC) and malignant melanoma (MM). This long-term non-interventional study will assess all types of skin malignancies (SCC, BCC, and MM) in DEB and JEB patients. It is an observational study of real-world treatment practices, in which patients will receive standard of care therapy whatever that may entail. Data will be obtained from two sources: clinical study centers in the European Union (EU) and the United Kingdom (UK), and pre-existing EB registries in the EU. Participants will be followed for up to 5 years, and information about the development and nature of skin malignancies will be collected over this time period both from patients who are taking and those who are not taking Filsuvez. ### Conditions Module **Conditions:** - Epidermolysis Bullosa, Dystrophic - Epidermolysis Bullosa, Junctional **Keywords:** - Filsuvez - Birch bark extract ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 580 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients in this cohort will be receiving treatment with Filsuvez for their EB. **Intervention Names:** - Drug: Filsuvez **Label:** Patients with dystrophic or junctional EB being treated with Filsuvez #### Arm Group 2 **Description:** Patients in this cohort will be receiving treatment other than Filsuvez or no treatment at all for their EB. **Label:** Patients with dystrophic or junctional EB not being treated with Filsuvez ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients with dystrophic or junctional EB being treated with Filsuvez **Description:** Topical gel **Name:** Filsuvez **Other Names:** - Birch bark extract **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Patients being treated with Filsuvez will be followed for occurrence of skin malignancies from the date of study enrolment until either the date of discontinuation (withdrawal of consent, withdrawal from the site or registry, physician decision, death, or lost to follow-up) or termination of the study **Measure:** Incidence of first skin malignancy during follow-up in EB patients receiving Filsuvez **Time Frame:** Up to 5 years #### Secondary Outcomes **Description:** Patients with EB who are not being treated with Filsuvez will be followed for occurrence of skin malignancies from the date of study enrolment until either the date of discontinuation (withdrawal of consent, withdrawal from the site or registry, physician decision, death, or lost to follow-up) or termination of the study **Measure:** Incidence of first skin malignancy during follow-up in EB patients not receiving Filsuvez **Time Frame:** Up to 5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with a confirmed diagnosis of dystrophic EB or junctional EB Exclusion Criteria: * None **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Patients with dystrophic EB or junctional EB, whether they are receiving Filsuvez, receiving another treatment for EB, or not receiving any treatment. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Chiesi Clinical Trials **Phone:** +3905212791 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012868 - Term: Skin Abnormalities - ID: D000000013 - Term: Congenital Abnormalities - ID: D000012873 - Term: Skin Diseases, Genetic - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000012871 - Term: Skin Diseases - ID: D000012872 - Term: Skin Diseases, Vesiculobullous - ID: D000003095 - Term: Collagen Diseases - ID: D000003240 - Term: Connective Tissue Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15681 - Name: Skin Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7976 - Name: Epidermolysis Bullosa - Relevance: HIGH - As Found: Epidermolysis Bullosa - ID: M18587 - Name: Epidermolysis Bullosa, Junctional - Relevance: HIGH - As Found: Epidermolysis Bullosa, Junctional - ID: M18586 - Name: Epidermolysis Bullosa Dystrophica - Relevance: HIGH - As Found: Epidermolysis Bullosa, Dystrophic - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M15672 - Name: Skin Abnormalities - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M15676 - Name: Skin Diseases, Genetic - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M15675 - Name: Skin Diseases, Vesiculobullous - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: T2098 - Name: Epidermolysis Bullosa - Relevance: HIGH - As Found: Epidermolysis Bullosa - ID: T3164 - Name: Junctional Epidermolysis Bullosa - Relevance: HIGH - As Found: Epidermolysis Bullosa, Junctional - ID: T1991 - Name: Dystrophic Epidermolysis Bullosa - Relevance: HIGH - As Found: Epidermolysis Bullosa, Dystrophic ### Condition Browse Module - Meshes - ID: D000004820 - Term: Epidermolysis Bullosa - ID: D000016109 - Term: Epidermolysis Bullosa, Junctional - ID: D000016108 - Term: Epidermolysis Bullosa Dystrophica ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423560 **Acronym:** SPIFFERO **Brief Title:** Pulmonary Fibrosis After Severe COVID-19 Pneumonia **Official Title:** Evaluation of Pulmonary Fibrosis After Severe Interstitial Pneumonia Due to COVID-19 (SARS-CoV-2) #### Organization Study ID Info **ID:** CET 145-2024 #### Organization **Class:** OTHER **Full Name:** IRCCS San Raffaele ### Status Module #### Completion Date **Date:** 2024-05-16 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-03-01 **Type:** ACTUAL #### Start Date **Date:** 2020-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** IRCCS San Raffaele #### Responsible Party **Investigator Affiliation:** IRCCS San Raffaele **Investigator Full Name:** Gabriele Fragasso **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Patients discharged after hospitalization for COVID-19 pneumonia were retrospectively selected by radiologically established criteria that at admission presented at chest computed tomography (CT) (i) normal lung parenchyma \<50% of total lung volume; and/or (ii) area of lung consolidation \> 10%. All At discharge and after 9 months, all subjects underwent cardiological evaluation, echocardiogram, pulmonary function tests (PFT) both atby 3 and by 12 months after discharge. Chest CT was performed by 12 months after discharge and chest CT. Specifically, the magnitude of pulmonary involvement between baseline and follow-up was considered the primary endpoint of this study. Secondary endpoints of the study were results of respiratory function testing, echocardiographic parametersparameters, and persistence of symptoms. ### Conditions Module **Conditions:** - Pulmonary Fibrosis - COVID-19 **Keywords:** - COVID-19 - Pulmonary fibrosis - ARDS - Computed tomography - pulmonary function test ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 61 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Radiation: Computed tomography **Label:** Residual disease > 20% of the total lung volume was considered pathological at follow-up CT #### Arm Group 2 **Intervention Names:** - Radiation: Computed tomography **Label:** Residual disease < 20% of the total lung volume was considered pathological at follow-up CT ### Interventions #### Intervention 1 **Arm Group Labels:** - Residual disease < 20% of the total lung volume was considered pathological at follow-up CT - Residual disease > 20% of the total lung volume was considered pathological at follow-up CT **Description:** Follow-up computed tomography at 3-6 months and 12 months **Name:** Computed tomography **Other Names:** - Pulmonary function test - Echocardiography **Type:** RADIATION ### Outcomes Module #### Primary Outcomes **Measure:** The magnitude of pulmonary involvement **Time Frame:** 12 months #### Secondary Outcomes **Measure:** results of respiratory function testing **Time Frame:** 12 months **Measure:** echocardiographic parameters **Time Frame:** 12 months **Measure:** persistence of symptoms **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥ 18 * Hospitalization for severe COVID-19 pneumonia * Computed tomography during index hospitalization that showed: (i) normale lung parenchyma \< 50% of total lung volume and/or (ii) parenchymal consolidation \> 10% * Cardiological and pneumological visit, echocardiography and pulmonary function test at 3 and 12 months from hospital discharge * Computed tomography by 12 months from hospital discharge Exclusion Criteria: * Age \< 18 * Absence of previously cited test. **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients hospitalized for sever COVID-19 pneumonia and successively discharge and with a 1-year follow-up ### Contacts Locations Module #### Locations **Location 1:** **City:** Milano **Country:** Italy **Facility:** IRCCS San Raffaele **State:** Lombardia **Zip:** 20132 #### Overall Officials **Official 1:** **Affiliation:** IRCCS San Raffaele **Name:** Gabriele Fragasso, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011024 - Term: Pneumonia, Viral - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000014777 - Term: Virus Diseases - ID: D000018352 - Term: Coronavirus Infections - ID: D000003333 - Term: Coronaviridae Infections - ID: D000030341 - Term: Nidovirales Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000010335 - Term: Pathologic Processes - ID: D000017563 - Term: Lung Diseases, Interstitial ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections ### Condition Browse Module - Browse Leaves - ID: M14512 - Name: Pulmonary Fibrosis - Relevance: HIGH - As Found: Pulmonary Fibrosis - ID: M8485 - Name: Fibrosis - Relevance: HIGH - As Found: Fibrosis - ID: M2561 - Name: COVID-19 - Relevance: HIGH - As Found: COVID-19 - ID: M13904 - Name: Pneumonia - Relevance: HIGH - As Found: Pneumonia - ID: M13914 - Name: Pneumonia, Viral - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M20490 - Name: Coronavirus Infections - Relevance: LOW - As Found: Unknown - ID: M6555 - Name: Coronaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M23685 - Name: Nidovirales Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M19813 - Name: Lung Diseases, Interstitial - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000086382 - Term: COVID-19 - ID: D000011014 - Term: Pneumonia - ID: D000011658 - Term: Pulmonary Fibrosis - ID: D000005355 - Term: Fibrosis ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423547 **Brief Title:** Risk Warning Model of Postoperative Delirium and Long-term Cognitive Dysfunction in Elderly Patients **Official Title:** Risk Warning Model of Postoperative Delirium and Long-term Cognitive Dysfunction in Elderly Patients Based on Autonomous Evolutionary Neural Network Algorithm #### Organization Study ID Info **ID:** 62376168 #### Organization **Class:** OTHER **Full Name:** Xuanwu Hospital, Beijing ### Status Module #### Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Chongqing Institute of Green and Intelligent Technology, Chinese Academy of Sciences #### Lead Sponsor **Class:** OTHER **Name:** Xuanwu Hospital, Beijing #### 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 incidence of postoperative delirium in elderly patients is high, which can lead to long-term postoperative neurocognitive disorders. Its high risk factors are not yet clear. At present, there is a lack of early diagnosis and alarm technology for perioperative neurocognitive disorders, which can not achieve early intervention and effective treatment. By artificial intelligence and autonomously evolutionary neural network algorithm, relying on multi-source clinical big data, we explored the use of Bayesian network to optimize the anesthesia decision-making system in enhanced recovery after surgery, and established risk prediction model for perioperative critical events. It is expected that this method will also help to establish a risk prediction model for postoperative delirium and long-term postoperative neurocognitive disorders. This project plans to collect the perioperative sensitive parameters of anesthesia machine, multi-parameter monitor, EEG monitor,fMRI and HIS system, to explore the evolution process of data characteristics by feature fusion.We also plan to quickly screen key perioperative risk characteristics of postoperative delirium from massive clinical data through feature selection, to explore the high risk factors of long-term postoperative neurocognitive disorders developing from postoperative delirium. Finally, with multi-center intelligent analysis，the risk prediction model of postoperative delirium and long-term postoperative neurocognitive disorders will be constructed. **Detailed Description:** This project intends to collect and identify clinical monitoring data of anesthesia machine, multi-parameter monitor and brain function monitor on the basis of the team's previous series of studies on cognitive function protection of elderly patients in perioperative period and the research on tracking and warning of critical illness events and decision support services based on artificial intelligence. HIS clinical data and classified and tracked fMRI imaging data were integrated to form a large data set related to perioperative cognitive function of elderly patients. Based on pNCD clinical diagnostic information and fMRI imaging diagnostic information, a brain adverse event prediction system capable of intelligent extraction of clinical key information and real-time early warning was established by using key technologies such as data quality control, real-time collection and identification of multi-source clinical monitoring data, and artificial intelligence adverse event prediction. ### Conditions Module **Conditions:** - Postoperative Delirium - Postoperative Neurocognitive Disorder - Surgery **Keywords:** - postoperative delirium; - postoperative neurocognitive disorder; - risk prediction model; - artificial intelligence; - evolutionary neural network ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 10000 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Year ### Arms Interventions Module #### Arm Group 1 **Description:** Delirium (CAM scale ) was assessed 7 days after surgery and divided into POD and non-POD groups; one of the above scenarios indicated postoperative delirium;The patients in the POD group were evaluated for cognitive function at 1 month and 12 months after surgery to determine whether pNCD occurred. The patients in the POD group were further divided into pNCD subgroup and non-PNCD subgroup, and EEG data collection and fMRI scanning were performed **Intervention Names:** - Other: no intervention **Label:** postoperative delirium(POD) and postoperative neurocognitive disorder(pNCD) ### Interventions #### Intervention 1 **Arm Group Labels:** - postoperative delirium(POD) and postoperative neurocognitive disorder(pNCD) **Description:** this is an observation study,no intervention **Name:** no intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The feature selection technique in artificial intelligence was used to screen and analyze data from a large dataset of clinical care after fusion The risk factors with the highest probability of PND occurrence can be screened from a large number of characteristics,By screening the risk factors that have the highest correlation with the probability of POD occurrence, combined with the comparison of fMRI imaging data of different groups of large sample size POD patients with long-term conversion to pNCD group and non-PNCD group, the brain network mechanism and perioperative high risk factors of POD conversion to long-term cognitive dysfunction were further explored. **Measure:** Screening for risk factors of perioperative cognitive dysfunction **Time Frame:** 2024.4.1-2027.12.31 **Description:** The monitoring data of surgical patients contains a large amount of medical information, and the analysis and modeling of the data can provide effective early warning and intervention. The project intends to adopt EEG time-frequency feature extraction and analysis, EEG micro-state analysis, and brain network analysis, and adopt feature fusion technology to fuse various features into unified features of patients. On this basis, a prediction model of adverse brain function events based on domain adaptation algorithm was constructed to realize real-time tracking, early diagnosis and early warning of postoperative delirium and long-term cognitive dysfunction in elderly patients **Measure:** Establish a prediction system for adverse brain function events **Time Frame:** 2025.1.1-2027.12.31 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients ≥65 years of age who have undergone surgical anesthesia; Sign informed consent Exclusion Criteria: * Inability to complete cognitive function assessment; Illiteracy, hearing impairment or visual impairment; He has a history of epilepsy, depression, schizophrenia, Alzheimer's disease and other psychiatric and neurological diseases **Maximum Age:** 100 Years **Minimum Age:** 65 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - OLDER_ADULT **Study Population:** Patients 65\~100 years of age who have undergone surgical anesthesia ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** lei zhao **Phone:** +8613811035886 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** xia li li **Phone:** +86818810616341 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** xuanwu hospital of capital medical university,Beijing **Name:** lei zhao **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** Chongqing Institute of Green and Intelligent Technology, Chinese Academy of Sciences **Name:** yong yang **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** xuanwu hospital of capital medical university,Beijing **Name:** yi an **Role:** PRINCIPAL_INVESTIGATOR **Official 4:** **Affiliation:** xuanwu hospital of capital medical university,Beijing **Name:** xia li li **Role:** PRINCIPAL_INVESTIGATOR **Official 5:** **Affiliation:** xuanwu hospital of capital medical university,Beijing **Name:** yang liu **Role:** PRINCIPAL_INVESTIGATOR **Official 6:** **Affiliation:** xuanwu hospital of capital medical university,Beijing **Name:** yi shu yang **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Patel A, Zhang M, Liao G, Karkache W, Montroy J, Fergusson DA, Khadaroo RG, Tran DTT, McIsaac DI, Lalu MM. A Systematic Review and Meta-analysis Examining the Impact of Age on Perioperative Inflammatory Biomarkers. Anesth Analg. 2022 Apr 1;134(4):751-764. doi: 10.1213/ANE.0000000000005832. **PMID:** 34962902 **Citation:** An Y, Zhao L, Wang T, Huang J, Xiao W, Wang P, Li L, Li Z, Chen X. Preemptive oxycodone is superior to equal dose of sufentanil to reduce visceral pain and inflammatory markers after surgery: a randomized controlled trail. BMC Anesthesiol. 2019 Jun 11;19(1):96. doi: 10.1186/s12871-019-0775-x. **PMID:** 31185942 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003221 - Term: Confusion - ID: D000019954 - Term: Neurobehavioral Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000001523 - Term: Mental Disorders - ID: D000003072 - Term: Cognition Disorders - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6894 - Name: Delirium - Relevance: HIGH - As Found: Delirium - ID: M29705 - Name: Cognitive Dysfunction - Relevance: HIGH - As Found: Cognitive Dysfunction - ID: M21836 - Name: Neurocognitive Disorders - Relevance: HIGH - As Found: Neurocognitive Disorders - ID: M772 - Name: Emergence Delirium - Relevance: HIGH - As Found: Postoperative Delirium - ID: M6446 - Name: Confusion - Relevance: LOW - As Found: Unknown - ID: M21826 - Name: Neurobehavioral Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M6301 - Name: Cognition Disorders - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003693 - Term: Delirium - ID: D000071257 - Term: Emergence Delirium - ID: D000060825 - Term: Cognitive Dysfunction - ID: D000019965 - Term: Neurocognitive Disorders ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423534 **Brief Title:** Empowering New Mothers: Exploring the Effect of Breastfeeding Health Educational Program on Practices and Feeding Self-Efficacy of Primigravida in Saudi Arabia **Official Title:** Empowering New Mothers: Exploring the Effect of Breastfeeding Health Educational Program on Practices and Feeding Self-Efficacy of Primigravida in Saudi Arabia #### Organization Study ID Info **ID:** H-2024-126 #### Organization **Class:** OTHER **Full Name:** Alexandria University ### Status Module #### Completion Date **Date:** 2024-08-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Alexandria University #### Responsible Party **Investigator Affiliation:** Alexandria University **Investigator Full Name:** Mahmoud Khedr **Investigator Title:** Lecturer **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Being pregnant causes a mother and her child to form a maternal tie, and the birth of the child fills the mother with an immense amount of love and happiness. Breastfeeding is how a mother and infant make their initial touch. Breastfeeding is a mother's priceless gift to her infant and nature's own method of nurturing a baby. **Detailed Description:** This study will be done to evaluate the primigravida mother's breastfeeding's knowledge, attitude and corrective technique through the implementation of an educational program and to ascertain the efficacy of such a program. ### Conditions Module **Conditions:** - Primigravida Women ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 70 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Each primigravida in the study group during the last three trimesters will receive three sessions of knowledge, breast care, and breastfeeding technique after filling out a questionnaire (pretest). During 1 month from delivery, we will conduct a post-test with them (after 2 weeks and after 4 weeks) to explore the effect of breastfeeding health educational programs on practices and breastfeeding self-efficacy **Intervention Names:** - Behavioral: Breastfeeding Health Educational Program **Label:** Study GROUP **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The control group was selected first and received a brochure leaflet delivered by the researcher. They didn't receive the health educational program **Intervention Names:** - Behavioral: Breastfeeding Health Educational Program **Label:** Control group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Control group - Study GROUP **Description:** Breastfeeding is a mother's priceless gift to her infant and nature's own method of nurturing a baby. Therefore, this study will be conducted to evaluate the primigravida mother's breastfeeding's knowledge, attitude and corrective technique through the implementation of an educational program and to ascertain the efficacy of such a program. **Name:** Breastfeeding Health Educational Program **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** It was developed by Tella et al. (2016) and comprised 12 questions that were assessed in various areas under various breastfeeding techniques practice. **Measure:** A preformatted structured questionnaire **Time Frame:** 3 months **Description:** It was adopted (Dennis, 2003) that assess maternal self-efficacy for breastfeeding throughout all stages of the study. The BSES-SF is a Likert scale with 14 items organized into two domains, namely: technical and intrapersonal thoughts. **Measure:** Self-Efficacy Scale - Short-Form (BSES-SF) **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Primigravida mothers who regularly visit maternity hospitals at Hail and Bisha City. * Primigravida mothers during last three trimester and 1 month after delivery * No problems during pregnant and have a healthy baby * Primigravida mothers who are not contraindicated to breastfeeding Exclusion Criteria: * Multigravida mothers and pregnant women during first and second trimester **Maximum Age:** 45 Years **Minimum Age:** 17 Years **Sex:** FEMALE **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Hail **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Asmaa Ali - **Phone:** 543132470 - **Role:** CONTACT **Country:** Saudi Arabia **Facility:** Faculty of Nursing, Hail university **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423521 **Acronym:** VAPUST **Brief Title:** Value Analysis in Patients Undergoing Self-Management Training Using a Coagulometer **Official Title:** Value Analysis in Patients Undergoing Anticoagulant Therapy: Impact of Self-management Training Using a Coagulometer #### Organization Study ID Info **ID:** 1057/2021 #### Organization **Class:** OTHER **Full Name:** Value for Health CoLAB ### Status Module #### Completion Date **Date:** 2024-04-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-05 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-04 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-04-01 **Type:** ACTUAL #### Start Date **Date:** 2021-10-10 **Type:** ACTUAL **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** NOVA Medical School **Class:** INDUSTRY **Name:** Roche Diagnostics GmbH #### Lead Sponsor **Class:** OTHER **Name:** Ana Rita Londral, PhD #### Responsible Party **Investigator Affiliation:** Value for Health CoLAB **Investigator Full Name:** Ana Rita Londral, PhD **Investigator Title:** Director **Type:** SPONSOR_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:** Prior research has not assessed the value of remote patient monitoring (RPM) systems for patients undergoing anticoagulation therapy after cardiac surgery. This study aims to assess whether the clinical follow-up through RPM yields comparable outcomes with the standard protocol. A crossover trial assigned participants to SOC-RPM or RPM-SOC, starting with the standard of care (SOC) for the first 6 months after surgery and using RPM for the following 6 months, or vice-versa, respectively. During RPM, patients used the Coaguchek© to accurately measure International Normalized Ratio values and a mobile text-based chatbot to report PROs and adjust the therapeutic dosage. The study assessed patients' and clinicians' experience with RPM and compared direct costs. **Detailed Description:** The main objective of this pilot study was to evaluate the outcomes and costs of a digital clinical service to support patients with anticoagulant therapy after cardiac surgery. This study used an RPM-based system with a portable coagulometer for clinical follow-up and self-management of INR control and compared with the standard of care (SOC). In addition, this study seeks to assess patients' and clinical teams' satisfaction and experience. Patients were recruited in sequential order based on their availability in the cardiothoracic surgery department. The participants were assigned into two arms: one would follow the SOC for the first six months and then receive the RPM intervention for the following six months (SOC-RPM); the other group would receive the intervention (RPM) for the first six months and then follow the SOC for the remaining six months (RPM-SOC). Blinding was not feasible due to the nature of the trial, and both patients and the clinical team were aware of the follow-up being conducted. In this study, it was decided that a washout period was not required. This was because withdrawing effective follow-up care for a washout period is not possible, as patients need to be constantly monitored to ensure effective treatment, thus preventing thromboembolic events. The study was conducted for twelve months, as follows: 1. Patients received a kit with a Coagulometer-CoaguChek® (Roche Diagnostics, Switzerland) and the necessary test strips for use during the period established, as well as written instructions on how to take the measurements, and were registered on the monitoring platform. 2. Patients received periodic text messages on their smartphones to report the INR value, and they responded to messages regarding their symptoms related to anticoagulant therapy and the INR value. 3. The clinical team received notifications if patients' reports had been assessed outside therapeutic standards and then sent a text message back with the medication adjustment. ### Conditions Module **Conditions:** - Post-Cardiac Surgery Patients **Keywords:** - Digital healthcare - Telemedice - Remote Patient Monitoring - Antocoagulation Therapy ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 28 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** SOC-RPM arm, would follow the Standard of Care (SOC) for the first six months and then receive the Remote Patient Monitoring (RPM). **Intervention Names:** - Other: Standard of Care (SOC) **Label:** SOC-RPM **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** RPM-SOC arm: would receive the intervention (RPM) for the first six months and then follow the SOC for the remaining six months. **Intervention Names:** - Other: Remote Patient Monitoring (RPM) **Label:** RPM-SOC **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - SOC-RPM **Description:** The SOC intervention constitutes the common clinical practice of care that is habitually performed after cardiac surgery to manage anticoagulation therapies. **Name:** Standard of Care (SOC) **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - RPM-SOC **Description:** The RPM intervention involves the use of a remote patient monitoring (RPM) system with a portable coagulometer for the clinical follow-up and self-management of International Normalized Ratio (INR) control in patients undergoing anticoagulant therapy post-cardiac surgery. Patients were provided with a Coagulometer-CoaguChek® (Roche Diagnostics, Switzerland) kit and test strips, along with written instructions for conducting measurements. They were also enrolled in a monitoring platform. Patients received regular text messages on their smartphones to report their INR values and symptoms related to anticoagulant therapy. The clinical team received notifications if patients\&amp;#39; reports fell outside therapeutic standards and then responded with medication adjustments via text message. **Name:** Remote Patient Monitoring (RPM) **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The primary endpoint was the patient's TTR for INR values among the programs, i.e., a comparison between SOC and RPM over time. The TTR for INR value was self-measured by the portable monitor and calculated by the Rosendaal method of lineal interpolation **Measure:** Time in Therapeutic Range (TTR) for International Normalized Ratio (INR) **Time Frame:** From enrollment to the end of treatment at 12 months #### Secondary Outcomes **Description:** Zero is equivalent to no hypoagulation symptoms and more than one indicates a symptom **Measure:** Number of events of hypocoagulation symptoms **Time Frame:** From enrollment to the end of treatment at 12 months **Description:** . A questionnaire with 13 self-reported questions was used to evaluate patient experience and satisfaction. The first four questions measured experience, while the following nine focused on satisfaction. The responses were rated on a scale of disagree to agree, with 1-4 points assigned to each response. To prevent ceiling and floor effects in our tool, the questions numbered '2', '11', and '12' were calculated as "inverted," and an optional open question was included. The questionnaire used to assess experience and satisfaction is not validated, precluding external validity. Still, it was used due to the lack of instruments in Portuguese language to assess the experience and satisfaction of digital health RPM-based systems. **Measure:** Patient Experience and Satisfaction **Time Frame:** From enrollment to the end of treatment at 12 months **Description:** The method used in the trial compared the average cost per patient in standard of care (SOC) versus remote patient monitoring (RPM) using the Time-Driven Activity-Based Costing (TDABC) method from the perspective of the Public National Healthcare Service (NHS). The method involved mapping patient pathway activities and identifying direct costs such as healthcare professionals, facilities, equipment and technology, and consumables. Costs for healthcare professionals, equipment and technology, and facilities were determined based on market value, depreciation rate, and public salary scale. Travel costs for patients undergoing SOC were considered, and all monetary values are in Euros as of 2023. **Measure:** Costs **Time Frame:** From enrollment to the end of treatment at 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * equal or more than 18 years old and with a smartphone Exclusion Criteria: * analphabetism, poor health, low digital literacy level and inability to use the RPM alone or with caregiver support **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Lisboa **Country:** Portugal **Facility:** Hospital de Santa Marta **Zip:** 1169-024 #### Overall Officials **Official 1:** **Affiliation:** Value for Health CoLAB **Name:** Ana Rita Londral, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Sharma P, Scotland G, Cruickshank M, Tassie E, Fraser C, Burton C, Croal B, Ramsay CR, Brazzelli M. Is self-monitoring an effective option for people receiving long-term vitamin K antagonist therapy? A systematic review and economic evaluation. BMJ Open. 2015 Jun 25;5(6):e007758. doi: 10.1136/bmjopen-2015-007758. **PMID:** 26112222 **Citation:** Menendez-Jandula B, Garcia-Erce JA, Zazo C, Larrad-Mur L. Long-term effectiveness and safety of self-management of oral anticoagulants in real-world settings. BMC Cardiovasc Disord. 2019 Aug 2;19(1):186. doi: 10.1186/s12872-019-1168-2. Erratum In: BMC Cardiovasc Disord. 2019 Nov 26;19(1):263. **PMID:** 31375070 **Citation:** Azevedo S, Guede-Fernandez F, von Hafe F, Dias P, Lopes I, Cardoso N, Coelho P, Santos J, Fragata J, Vital C, Semedo H, Gualdino A, Londral A. Scaling-up digital follow-up care services: collaborative development and implementation of Remote Patient Monitoring pilot initiatives to increase access to follow-up care. Front Digit Health. 2022 Dec 7;4:1006447. doi: 10.3389/fdgth.2022.1006447. eCollection 2022. **PMID:** 36569802 **Citation:** Wu Y, Wang X, Zhou M, Huang Z, Liu L, Cong L. Application of eHealth Tools in Anticoagulation Management After Cardiac Valve Replacement: Scoping Review Coupled With Bibliometric Analysis. JMIR Mhealth Uhealth. 2024 Jan 5;12:e48716. doi: 10.2196/48716. **PMID:** 38180783 **Citation:** Huang Y, Xie Y, Huang L, Han Z. The Value of Anticoagulation Management Combining Telemedicine and Self-Testing in Cardiovascular Diseases: A Meta-Analysis of Randomized Controlled Trials. Ther Clin Risk Manag. 2023 Mar 14;19:279-290. doi: 10.2147/TCRM.S395578. eCollection 2023. **PMID:** 36941980 ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: AnCoag - Name: Anticoagulants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4244 - Name: Anticoagulants - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423508 **Acronym:** PROTEGI **Brief Title:** PRObing The Efficacy of Commercial Stage Storage Buffers and Evaluating Gut Metaproteome Variability Between Individuals **Official Title:** PRObing The Efficacy of Commercial Stage Storage Buffers and Evaluating Gut Metaproteome Variability Between Individuals #### Organization Study ID Info **ID:** EK_01149_3/05/2024 #### Organization **Class:** OTHER **Full Name:** University of Vienna ### Status Module #### Completion Date **Date:** 2025-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-03 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Vienna #### Responsible Party **Investigator Affiliation:** University of Vienna **Investigator Full Name:** Giacomo Carta **Investigator Title:** Postdoc **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The study aims to assess the effectiveness of various commercial and non-hazardous buffers for the storage of human gut fecal samples over time. This evaluation will be conducted by comparing the performance of these buffers against directly frozen samples using metaproteomic analysis. The study is motivated by the need for standardized protocols for sample preservation in metaproteomic research, particularly focusing on protein preservation in fecal samples. By investigating proteomic, taxonomic, and functional identifications, the research seeks to provide insights into the reliability of these buffers as storage solutions. Additionally, the study plans to explore inter- and intra-individual variabilities at the proteome level by periodically collecting fecal samples from volunteers, complementing existing knowledge in metaproteomics. Overall, the study addresses a critical gap in the field and has the potential to enhance reproducibility and comparability across metaproteomic studies **Detailed Description:** A. Introduction: Metaproteomics studies the entire protein complement of a microbial community and offers insight into intricate ecosystems like the gut microbiome. Metaproteomics allows researchers to delve deep into gut microbiomes, providing insights into these microbial inhabitants, abundance and functional activities. This knowledge has been instrumental in elucidating the mechanisms underlying various diseases, such as inflammatory bowel disease, and obesity. Researchers can develop targeted strategies for personalized medicine and precision healthcare based on the underlying biology by identifying key protein signatures. In gut microbiome studies, standardized sample collection and preservation are particularly crucial to preserve the integrity of the microbial community and its proteome. Indeed, to obtain reliable results it must be considered the susceptibility to environmental influences like temperature and oxygen amount. For gut microbiome metaproteomic studies, non-invasive or minimally invasive methods are preferred to minimize disruption, or contamination, and preserve the native microbial composition and protein profiles. Also, the sample handling and storage strategies affect the degradation of proteins and the microbial population stability. For this reason, immediate freezing, or preservation at low temperatures (e.g., -80°C) is often recommended to maintain sample integrity until analysis. However, using a cold chain for storage and transportation is not compatible with an on-site sampling strategy that is necessary for large-scale and delocalized studies. Moreover, it is less ideal, more expensive, and logistically tedious than potential room temperature options. Furthermore, present knowledge of the fecal sample collection/preservation methods is based on preserving nucleic acids or metabolites during the transportation to the laboratory for analysis. However, protein preservation requires different strategies and studies are scarce and rely on adopting the devices or reagents used in the case of nucleic acids or metabolites analysis. Thus, tailored, and standardized protocols together with metadata collection are essential for ensuring reproducibility and comparability across metaproteomic studies. The present study aims to evaluate the fitness of several commercial and non-hazardous buffers for the storage of human gut fecal samples over time. Fecal samples will be stored in five different buffers and will be benchmarked with directly frozen samples. Using metaproteomics the investigators will compare the proteomic, taxonomic, and functional identifications to understand the potential of these buffers as a reliable storage solution for human feces. This research is unique and to the best of our knowledge, no similar study has addressed this demanding question. Preliminary evidence in humans has shown inter- and intra-individual variability of the proteomes of the host and microbiomes. In particular, the intra-individual taxonomic and functional variation in the gut microbiome seems to be lower than inter-individual variation over time. However, metatranscriptomics profiles exhibited comparable variability within and between subjects. Therefore, using metaproteomics, investigators aim to assess the inter- and intra-individual variabilities at the proteome level by studying fecal samples periodically collected from participants. B. The academic and social relevance: The first part of the study aims to define the most effective storage buffer for preserving protein integrity during sample transportation from the site of collection to the site of processing - a key factor in the future of metaproteomics applied to health and disease. Despite its importance, a similar evaluation has not been performed for proteomic applications. This knowledge will be critical for academic purposes to be used for large-scale human fecal proteomic studies. For people to have their gut health examined through metaproteomics and unlock the potential of microbial communities-based personalized medicine and therapeutic interventions there will be a requirement for consistent sample collection and this study will provide it. The second part of the study is designed to understand the variability that can be observed in the gut microbiome composition and functions from the proteomics perspective. The gut microbiome is dynamic and is known to be altered by multiple factors such as diet, age, genetics, environment, etc. These variations can be broadly classified into inter- and intra-individual. Inter-individual variability refers to the differences observed between individuals within a population or group, and they can encompass a wide range of characteristics, including genetic makeup, physiological parameters, lifestyle factors, and environmental exposures. Understanding inter-individual variability from people of the same "community" is essential in fields such as personalized medicine, where tailored interventions account for individual differences to optimize treatment outcomes. Intra-individual variability, on the other hand, refers to variations observed within the same individual over time or under different conditions and can arise from biological fluctuations, such as circadian rhythms, hormonal fluctuations, or physiological responses to stimuli. Recognizing and characterizing intra-individual variability is crucial for accurately interpreting research findings and assessing the reliability of biological measurements, particularly in longitudinal studies or clinical monitoring scenarios. This study aims to understand these variabilities through the proteomics data collected from participants' fecal samples and define the variables detected in the gut microbiome. C. Objectives: 1. To identify the effect of five different buffers used for the storage and transportation of collected human fecal material, by metaproteomic profiles. 2. To determine the variability in microbiota and host proteomes at the inter- and intra-individual levels. D. Study Design: For the first phase, the investigators will deploy the following protocol for on-site fecal sampling and transport preservation: The participants (recruited among the members of our laboratory/Division) will be provided with 18 tubes (numbered 1-18; 15 ml conical centrifuge tubes; Ref# 339650, Thermo Scientific and 18 easy-to-use commercial swabs (C1052-50, Zymo Research) or spatulas (DNAGenotek). The 18 tubes correspond to three storage time points of 6 different experimental conditions: an empty tube (without preservation liquid) as a control sample and 5 different non-hazardous fecal preservation liquids: (a) In-house buffer (called LB) with SDS and Urea, commercially obtained (b) Zymo DNA/RNA Shield (R1100, Zymo Research), (c) Copan Amies buffer (480CE, Copan Italia SpA), (d) OMNIgene•GUT (OM200, DNAGenotek), (e) OMNImet•GUT (ME200, DNAGenotek). Briefly, LB, Zymo Shield, and OM200 are known to contain detergents that help to preserve the biomolecules, Copan Amies buffer is a nutrient-free media known to keep the cells viable and shown to have applications in culturomics, and ME200 is solvent based useful in metabolomic applications. In addition, the participants will receive a commercial stool catcher that is displayed over the toilet for facilitating fecal sampling (Servoprax Stuhlfaenger, Reference number H7 61000-50 from www.medundorg.de) and a little box with ice packs in which the three Control samples will be stored and transported to the lab. These ice-stored Control samples are key to evaluating the performance of the different storage buffers. The participants will bring the samples to our laboratory in the following 24 hours. Upon reception in the lab, the Control samples will be stored at -80°C until further biochemical processing using established protocols. The rest of the samples will be stored at +20°C inside an orbital shaker incubator for a total of 2, 5, and 10 days (simulating different storage/transport times, thereof). At the end of these time points, the samples will be stored at -80°C until further biochemical processing using established protocols. The metaproteomic profiles (indicating the taxonomical and functional changes in the gut microbiome and the host physiology; as in the previous experiment from these samples will inform us about the best preservation liquid (defined as the one where the microbiome composition and function are more like the Control sample). This experiment is necessary for initiating Phase II of the study, and it is novel in the field as no guidelines are established for best in-house fecal sampling practices in metaproteomics. Six healthy participants (among the members of the Systems Biology of Pain laboratory, Division of Pharmacology \&amp; Toxicology, Department of Pharmaceutical Sciences) will be recruited. This is a randomized study with no participant groups. Samples will be collected once and distributed to 18 tubes representing different conditions. A sample size of 6 subjects will be enough to find the best preservation solution and the sampling will be performed one time under normal bowel movement by the participants. In addition, the participants will fill out a questionnaire (attached) that includes information like age, sex, Body Mass Index, the gastrointestinal symptoms rating scale (GSRS), administration of antibiotics in the last 30 days before sample collection, the Bristol stool form scale (BSFS), and the approximate time needed for sample collection in the 18 tubes (to account for potential effects due to oxidation processes). For the second phase, the participants will be expected to collect fecal samples for 4 weeks during their regular defecation (ten different times maximum). They will be provided with an adequate number of 15ml conical centrifuge tubes (339650, Thermo Scientific) containing the best-performing preservation buffer (as defined in the first phase of the study, see above), and a commercial collection device with a stool catcher. Upon reception in the lab, the samples will be stored at -80°C until further biochemical processing using established protocols. In addition, the participants will fill out a questionnaire (see above). Participants will take part voluntarily in the experiment after receiving an explanation of all the risks and benefits of participating in the present study, and after signing the written informed consent form according to the Declaration of Helsinki (see the consent form, attached). The participants will be instructed and provided with necessary sampling devices to collect stool samples (see above) and submit the samples to the Department of Pharmacology and Toxicology at the earliest opportunity. Participants will be expected to complete self-administered questionnaires that include information like the one described above. For the second phase, 46 healthy participants (among the members of our laboratory/Division) will be recruited from both sexes (23 males and females) considering a possible dropout rate of 20%. This is a randomized study with no participant groups. The sample size was calculated based on the threshold of Eggerthella estimates with time. The statistics procedure used is F tests - two-way ANOVA with repeated measures with the following values Cohens'd = 0.75, 1-β= 0.80, and α= 0.05. A total of 400 - 460 samples are expected to be collected. ### Conditions Module **Conditions:** - Gut Microbiome - Buffer - Methodology Study - Fecal Microbiota - Variability **Keywords:** - storage buffer - fecal samples - human gut microbiome - metaproteomics - intra-individual variability - inter-individual variability ### Design Module #### Bio Spec **Description:** human fecal samples **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 52 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Identifying the most effective storage buffer for preserving protein integrity during the transportation of fecal samples from collection to processing sites, is essential for establishing consistent sample collection protocols, particularly for large-scale human fecal proteomic studies. Achieving consistency in sample collection is crucial for enabling individuals to have their gut health assessed via metaproteomics, unlocking the potential for personalized medicine and therapeutic interventions based on microbial communities. **Label:** storage buffer standardisation #### Arm Group 2 **Description:** the aim is to explore the inter- and intra-individual variability observed in gut microbiome composition and functions from a proteomic perspective. Understanding inter-individual variability differences is crucial for personalized medicine. Recognizing and characterizing intra-individual variability is essential for accurately interpreting research findings, particularly in longitudinal studies or clinical monitoring scenarios. This study aims to elucidate these variabilities using proteomic data from volunteers' fecal samples, shedding light on the variables detected in the gut microbiome and providing insights into its dynamic nature **Label:** inter- and intra-individual variability ### Outcomes Module #### Primary Outcomes **Description:** Eggerthella abundance will be checked in to the Metaproteomic profile of each fecal samples and inter/intra-individual variability will be assessed **Measure:** Eggerthella abundance **Time Frame:** From enrollment to the end of treatment at 4 weeks #### Secondary Outcomes **Description:** Age will be collected from each participant during the first interview **Measure:** Age **Time Frame:** From enrollment to the end of treatment at 4 weeks **Description:** Sex will be collected from each participant during the first interview **Measure:** Sex **Time Frame:** From enrollment to the end of treatment at 4 weeks **Description:** BMI will be collected from each participant during the first interview **Measure:** Body Mass Index (BMI) **Time Frame:** From enrollment to the end of treatment at 4 weeks **Description:** Antibiotic use in the previous 1 month before the study enrollment, will be collected from each participant during the first interview **Measure:** Antibiotic use **Time Frame:** From enrollment to the end of treatment at 4 weeks **Description:** The Bristol Stool Form Scale (BSFS), or Bristol stool scale, is a chart that can help classify stools into seven groups. Characterizing the stool based on its consistency can help identify if it is a healthy bowel movement. It will be administerd refearring to the the day(s) of the fecal sample collection(s) **Measure:** Bristrol Stool Form Scale (BSFS) **Time Frame:** From enrollment to the end of treatment at 4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * agreeing to participate after signing the informed consent form and * being 18-70 years old. Exclusion Criteria: * take antibiotics during the previous 1 month * had undergone gastrointestinal surgery **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** healthy volunteers (among the members of our laboratory/Division) will be recruited ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** David Gomez Varela PhD. Senior Scientist, PhD **Phone:** 1427755361 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Ranjith Kumar Ravi Kumar PhD- postdoc, PhD **Phone:** 1427755318 **Role:** CONTACT #### Locations **Location 1:** **City:** Vienna **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** David Gomez Varela, PhD - **Phone:** 1427755361 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Ranjith Kumar Ravi Kumar, PhD - **Phone:** +43142-775-5318 - **Role:** CONTACT **Country:** Austria **Facility:** UVienna **State:** Wien **Zip:** 1090 #### Overall Officials **Official 1:** **Affiliation:** University of Vienna **Name:** Giacomo Carta, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** anonymized data will be provided under scientific plausible request sent by email to the principal investigator **IPD Sharing:** NO ### References Module #### References **Citation:** Gomez-Varela D, Xian F, Grundtner S, Sondermann JR, Carta G, Schmidt M. Increasing taxonomic and functional characterization of host-microbiome interactions by DIA-PASEF metaproteomics. Front Microbiol. 2023 Oct 16;14:1258703. doi: 10.3389/fmicb.2023.1258703. eCollection 2023. **PMID:** 37908546 ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423495 **Brief Title:** Efficacy of Photobiomodulation in the Rehabilitation of Olfactory Dysfunctions Induced by Long COVID-19 **Official Title:** Efficacy of Photobiomodulation in the Rehabilitation of Olfactory Dysfunctions Induced by Long COVID-19 #### Organization Study ID Info **ID:** GaffreeGuinleUH #### Organization **Class:** OTHER **Full Name:** Gaffree & Guinle Universitary Hospital ### Status Module #### Completion Date **Date:** 2024-12-22 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2023-12-22 **Type:** ACTUAL #### Start Date **Date:** 2022-06-05 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-02-22 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Rio de Janeiro State Research Supporting Foundation (FAPERJ) #### Lead Sponsor **Class:** OTHER **Name:** Gaffree & Guinle Universitary Hospital #### Responsible Party **Investigator Affiliation:** Gaffree & Guinle Universitary Hospital **Investigator Full Name:** Deborah Santos Sales **Investigator Title:** Deborah Santos Sales **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** On January 30, 2020, the WHO (World Health Organization) declared the new coronavirus pandemic as the sixth public health emergency of international concern. In February 2020, the virus was designated by the Coronavirus Study Group of the International Committee on Virus Taxonomy as severe acute respiratory syndrome coronavirus 2. Many reports have described the appearance of olfactory or gustatory dysfunction simultaneously with other pre-established symptoms of COVID-19. Symptoms such as loss of taste or smell may appear 2 to 14 days after being infected with COVID-19. Worldwide, evidence regarding anosmia (loss of smell) and dysgeusia (change in taste) has been associated with COVID-19 infection. OBJECTIVES: To evaluate the effectiveness of low-intensity laser in treating changes in smell and taste after COVID-19 infection and map which changes obtained the best results. MATERIAL AND METHODS: This is an intervention study whose sample will consist of 30 individuals with loss of smell and taste for more than 6 months after COVID-19 infection, aged 18 years or older. **Detailed Description:** objective: To evaluate the effectiveness of low-intensity laser in resolving chemosensory symptoms caused by COVID-19. This is an intervention study. The sample will consist of 30 individuals who will be allocated to the low-intensity laser treatment group. The patients will come from research at the COVID-19 outpatient clinic at the Gafree Guinle University Hospital - UNIRIO. Patients who agree to participate in the study will be informed about the objective of the research and will sign an informed consent form. ### Conditions Module **Conditions:** - Anosmia - Ageusia - COVID-19 - Rehabilitation - Laser Therapy **Keywords:** - Anosmia - ageusia - COVID-19 - Rehabilitation - Photobiomodulation ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SEQUENTIAL **Intervention Model Description:** The sample will consist of 30 individuals who will be allocated to the low-intensity laser treatment group. ##### 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:** This is an intervention study. The sample will consist of 30 individuals who will be allocated to the low-intensity laser treatment group. **Intervention Names:** - Device: low-intensity laser treatment **Label:** low-intensity laser treatment group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - low-intensity laser treatment group **Description:** The experimental group will be subjected to a total of up to 24 sessions (2x a week for up to 12 weeks) of irradiation with red and infrared laser pulsed radiation, with 820mm wavelength, 60w power and 6 energy cages, applied in both nostrils and in 10 points under the tongue. **Name:** low-intensity laser treatment **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** evaluate the effectiveness of low-intensity laser **Measure:** effectiveness of low-intensity laser in the treatment of olfactory dysfunction in long term covid-19 **Time Frame:** 20 minutes session with photobiomodulation therapy twice a week, for a total of 16 sessions ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients who complained of loss of smell and taste more than 6 months after COVID-19 infection, aged 18 years or older, with proof of infection by PCR, will be included in the study. Exclusion Criteria: * Patients with comorbidities prior to COVID-19 infection that could interfere with the functions of smell and taste will be excluded from the study; patients with a history of head and neck cancer, epileptic patients; mouth breathing patients; and pregnant women. **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** DEBORAH S SALES, phd **Phone:** +5521982161520 **Role:** CONTACT #### Locations **Location 1:** **City:** Rio de Janeiro **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** DEBORAH S SALES, PHD - **Phone:** +5521982161520 - **Role:** CONTACT **Country:** Brazil **Facility:** university hospital Gafree Guinle **Status:** RECRUITING **Zip:** 20270004 #### Overall Officials **Official 1:** **Affiliation:** federal university of the state of rio de janeiro - UNIRIO **Name:** Claudia CF Vasconcelos, PHD **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** University hospital Gafree Guinle - UNIRIO **Name:** Mariana B Hammerle, MD **Role:** STUDY_CHAIR **Official 3:** **Affiliation:** University hospital Gafree Guinle - UNIRIO **Name:** DEBORAH SANTOS SALES, PHD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Hammerle MB, Sales DS, Pinheiro PG, Gouvea EG, de Almeida PIFM, de Araujo Davico C, Souza RS, Spedo CT, Nicaretta DH, Alvarenga RMP, Pires KL, Thuler LCS, Vasconcelos CCF. Cognitive Complaints Assessment and Neuropsychiatric Disorders After Mild COVID-19 Infection. Arch Clin Neuropsychol. 2023 Feb 18;38(2):196-204. doi: 10.1093/arclin/acac093. **PMID:** 36464245 **Citation:** Vasconcelos CCF, Hammerle MB, Sales DS, Rueda Lopes FC, Pinheiro PG, Gouvea EG, Alves MCDF, Pereira TV, Schmidt SL, Alvarenga RMP, Pires KL. Post-COVID-19 olfactory dysfunction: carbamazepine as a treatment option in a series of cases. J Neurovirol. 2022 Apr;28(2):312-318. doi: 10.1007/s13365-022-01066-3. Epub 2022 Apr 2. **PMID:** 35366736 #### See Also Links **Label:** Post-COVID-19 Olfactory and Gustatory Dysfunction: Photobiomodulation Therapy as a Treatment Option in a Series of Cases **URL:** https://openneurologyjournal.com/VOLUME/17/ELOCATOR/e1874205X2309190/FULLTEXT/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011024 - Term: Pneumonia, Viral - ID: D000011014 - Term: Pneumonia - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000014777 - Term: Virus Diseases - ID: D000018352 - Term: Coronavirus Infections - ID: D000003333 - Term: Coronaviridae Infections - ID: D000030341 - Term: Nidovirales Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000094025 - Term: Post-Infectious Disorders - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000000857 - Term: Olfaction Disorders - ID: D000012678 - Term: Sensation Disorders - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000013651 - Term: Taste Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M2561 - Name: COVID-19 - Relevance: HIGH - As Found: COVID-19 - ID: M3013 - Name: Post-Acute COVID-19 Syndrome - Relevance: HIGH - As Found: Long COVID - ID: M2570 - Name: Anosmia - Relevance: HIGH - As Found: Anosmia - ID: M3720 - Name: Ageusia - Relevance: HIGH - As Found: Ageusia - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M13904 - Name: Pneumonia - Relevance: LOW - As Found: Unknown - ID: M13914 - Name: Pneumonia, Viral - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M20490 - Name: Coronavirus Infections - Relevance: LOW - As Found: Unknown - ID: M6555 - Name: Coronaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M23685 - Name: Nidovirales Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M3014 - Name: Post-Infectious Disorders - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M4183 - Name: Olfaction Disorders - Relevance: LOW - As Found: Unknown - ID: M15490 - Name: Sensation Disorders - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M16423 - Name: Taste Disorders - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000086382 - Term: COVID-19 - ID: D000094024 - Term: Post-Acute COVID-19 Syndrome - ID: D000086582 - Term: Anosmia - ID: D000000370 - Term: Ageusia ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423482 **Brief Title:** Digitization Accuracy and Scannability of Two Different Implant-Supported Prosthodontic Framework Materials **Official Title:** Digitization Accuracy and Scannability of Two Different Implant-Supported Prosthodontic Framework Materials #### Organization Study ID Info **ID:** 0796-11/2023 #### Organization **Class:** OTHER **Full Name:** Alexandria University ### Status Module #### Completion Date **Date:** 2025-05-14 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05-14 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-14 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Nourhan Samy #### Responsible Party **Investigator Affiliation:** Alexandria University **Investigator Full Name:** Nourhan Samy **Investigator Title:** Ph.D student **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The present study aims to clinically evaluate and compare the scanning accuracy and the scannability of 2 different materials used in constructing frameworks for implant-supported prosthesis (titanium and PEEK). The objective of the present study is to evaluate the digitization accuracy and scannability of milled titanium and PEEK implant-supported frameworks in intra-oral conditions and to evaluate the accuracy of the superstructures designed and constructed over the intraorally scanned framework. **Detailed Description:** Background: For implementing a fully digital workflow, intraoral scanning of prosthetic frameworks may be required for editing purposes in some clinical scenarios. Different materials can be used in constructing implant-supported prosthetic frameworks. However, the scannability and the influence of the material used on the accuracy of the intraoral scan are still unclear. Aim of the study: The purpose of this in vivo study is to evaluate the scanning accuracy and the scannability of different framework materials and to assess the marginal adaptation and accuracy of the superstructures designed and constructed over different scanned framework materials. Materials and methods: Two milled maxillary implant-supported frameworks constructed from 2 different materials will be used in this study. Group I will be constructed from titanium and group II from Poly-Ether-Ether-Ketone (PEEK). The frameworks will be digitized by using a desktop scanner (Tabletop Scanner, Medit T-310; Medit Corp). The STL file produced will be considered as a reference file. Each framework will be scanned intraorally (n=10) by using an intraoral scanner (IOS) (Medit i700; Medit Corp). The STL files obtained from the intraoral scanner will be compared to the reference STL file to assess the scannability. The unscanned surface area in a preset time limit will be used to determine the scannability of each framework. To evaluate the scanning accuracy, all STL files will be imported into a surface-matching software program (Medit Design v3.0.6 Build 286; Medit Corp) where deviation measurements in (μm) will be calculated. A total of 20 superstructures made of nano-ceramic hybrid resin (Flexcera™ Smile Ultra) will be 3D-printed from each STL file obtained from intraoral scanning of the frameworks and then the marginal adaptation will be evaluated by using a stereomicroscope (SZ1145TR; Olympus, Japan). The accuracy will also be assessed by using a surface-matching software program (Geomagic Control X v.2018.1.1; 3D Systems). Analysis: Data will be collected, tabulated, and statistically analyzed by using the appropriate statistical tests. Keywords: Digitization, accuracy, trueness, precision, scannability, implant-supported frameworks, superstructures, marginal adaptation, titanium, PEEK, digital workflow, editing, nano-ceramic hybrid resin. ### Conditions Module **Conditions:** - Digitalization Accuracy **Keywords:** - Digitization, accuracy, trueness, precision, scannability, implant-supported frameworks, superstructures, marginal adaptation, titanium, PEEK ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 1 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: PEEK bar **Label:** PEEK bar **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Other: Titanium bar **Label:** Titanium bar **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - PEEK bar **Description:** The framework will be constructed from Poly-Ether-Ether-Ketone (PEEK). The framework will be digitized by using a desktop scanner (Tabletop Scanner, Medit T-310; Medit Corp). The STL file produced will be considered as a reference file. Each framework will be scanned intraorally (n=10) by using an intraoral scanner (IOS) (Medit i700; Medit Corp). **Name:** PEEK bar **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Titanium bar **Description:** The framework will be constructed from titanium. The framework will be digitized by using a desktop scanner (Tabletop Scanner, Medit T-310; Medit Corp). The STL file produced will be considered as a reference file. Each framework will be scanned intraorally (n=10) by using an intraoral scanner (IOS) (Medit i700; Medit Corp). **Name:** Titanium bar **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** All scans obtained will be cropped eliminating soft tissue areas guided by the bar's finish line. The STL(D) file obtained from scanning the frameworks by using the desktop scanner will be used as reference scan for the assessment of trueness in the study, to measure the discrepancy with the corresponding 10 STLI files in each group. In each reference STL(D) file, the framework will be selected and used for alignment with their corresponding STL(I) with the best fit alignment algorithm to assess trueness, and then all the STL(I) in each material group will be superimposed to assess precision by using a specialized software program (Medit link). For the quantitative evaluation of 3D deviations between the reference STL(D) and the target data STL(I), the software program deviation display mode will be used to produce color-difference maps from which RMS (root mean square) will be calculated for statistical analysis. **Measure:** Digitization accuracy of the two different framework materials. **Time Frame:** one year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Maxillary edentulous adult patient with a good health status classified as ASA I or II physical status and having maxillary osseointegrated dental implants. 2. Adequate maxillary restorative space (6-8 mm). 3. Adequate zone of keratinized tissue (at least 2 mm). 4. Presence of an antagonistic dentate or rehabilitated arch. Exclusion Criteria: 1. A systemic disease that compromises osseointegration such as uncontrolled diabetes mellitus or metabolic bone diseases. 2. Improper implant position. 3. Heavy smoking. 4. Inability to obtain written informed consent. - **Healthy Volunteers:** True **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** nourhan Samy Emam, BDS, Msc, Ph.D student **Phone:** 01099671431 **Role:** CONTACT #### Locations **Location 1:** **City:** Alexandria **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** nourhan Samy Emam, BDS,Msc, Ph.D - **Phone:** 01099671431 - **Role:** CONTACT **Country:** Egypt **Facility:** Alexandria University **State:** Stanly **Status:** RECRUITING **Zip:** 21500 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### 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: M8134 - Name: Ether - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423469 **Brief Title:** Noninvasive Intracranial Pressure Waveforms Assessment in Traumatic Brain Injury **Official Title:** A Multicenter Observational Cohort for the Determination of Noninvasive Intracranial Pressure Waveforms Role in Traumatic Brain Injury #### Organization Study ID Info **ID:** 39348920.1.1001.0068 #### Organization **Class:** OTHER **Full Name:** University of Sao Paulo ### Status Module #### Completion Date **Date:** 2024-04-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-03-30 **Type:** ACTUAL #### Start Date **Date:** 2020-02-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Sergio Brasil, MD #### Responsible Party **Investigator Affiliation:** University of Sao Paulo **Investigator Full Name:** Sergio Brasil, MD **Investigator Title:** MD. PhD **Type:** SPONSOR_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:** In clinical practice, hospital admission of patients with altered level of consciousness ranging from drowsiness to decreasing response states or coma is extremely common. This clinical condition demands effective investigation and early treatment. Imaging and laboratory tests have played increasingly relevant roles in supporting clinical research. One of the main causes of coma is intracranial hypertension (IH), with traumatic brain injuries (TBI) and cerebral hemorrhages being the major contributors to its development. IH increases the risk of secondary damage in these populations, and consequently, morbidity and mortality. Clinical studies show that adequate intracranial pressure (ICP) control in TBI patients reduces mortality and increases functionality. Unfortunately, the most accurate way to measure and evaluate the ICP is through a catheter located inside the skull, and its perforation is required for this purpose. Several studies have attempted to identify noninvasive solutions for ICP monitoring; however, to date, none of the techniques gathered sufficient evidence to replace invasive monitors. Recently, an extensometer device has been developed, which only maintains contact with the skull's skin and therefore eliminates the need for its perforation, being able to obtain recordings of cranial dilatation at each heartbeat and consequently reflecting brain compliance. In vivo studies have identified excellent qualitative correlation with catheter ICP recordings. However, this device was evaluated only in a limited number of clinical cohorts and the correlations between the information provided by this device with patients outcomes is still poor. Therefore, this project aims primarily to evaluate the use of this noninvasive brain compliance monitoring system in a cohort of TBI patients. ### Conditions Module **Conditions:** - Traumatic Brain Injury **Keywords:** - traumatic brain injury - intracranial pressure - intracranial compliance - intracranial pressure waveforms - neurological noninvasive monitoring ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 345 **Type:** ACTUAL **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 6 Months ### Outcomes Module #### Other Outcomes **Description:** Are brain4care biometrics correlated with invasive intracranial pressure provided by ventricular catheters or parenchymal probes? **Measure:** Correlation with invasive information **Time Frame:** Fifteen days #### Primary Outcomes **Description:** Is in-hospital mortality correlated with poorer brain4care biometrics? **Measure:** In-hospital mortality **Time Frame:** One month #### Secondary Outcomes **Description:** Is morbidity correlated with poorer brain4care biometrics? **Measure:** Morbidity **Time Frame:** Six months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Moderate to severe traumatic brain injury with less than 24 hours. Exclusion Criteria: * Primary decompressive craniectomy * Brain death signs at admission * Severe hemodynamic instability **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients of any gender, older than 18 years, with very acute moderate or severe TBI will be included just after stabilization and any surgical evacuation procedure performed. ### IPD Sharing Statement Module **Description:** Possibly some anonymous data can be shared with other researchers upon reasonable request. **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Gulamali F, Jayaraman P, Sawant AS, Desman J, Fox B, Chang A, Soong BY, Arivazaghan N, Reynolds AS, Duong SQ, Vaid A, Kovatch P, Freeman R, Hofer IS, Sakhuja A, Dangayach NS, Reich DS, Charney AW, Nadkarni GN. Derivation, External Validation and Clinical Implications of a deep learning approach for intracranial pressure estimation using non-cranial waveform measurements. medRxiv [Preprint]. 2024 Jan 30:2024.01.30.24301974. doi: 10.1101/2024.01.30.24301974. **PMID:** 38352556 **Citation:** Kawoos U, McCarron RM, Auker CR, Chavko M. Advances in Intracranial Pressure Monitoring and Its Significance in Managing Traumatic Brain Injury. Int J Mol Sci. 2015 Dec 4;16(12):28979-97. doi: 10.3390/ijms161226146. **PMID:** 26690122 **Citation:** de Moraes FM, Rocha E, Barros FCD, Freitas FGR, Miranda M, Valiente RA, de Andrade JBC, Neto FEAC, Silva GS. Waveform Morphology as a Surrogate for ICP Monitoring: A Comparison Between an Invasive and a Noninvasive Method. Neurocrit Care. 2022 Aug;37(1):219-227. doi: 10.1007/s12028-022-01477-4. Epub 2022 Mar 24. **PMID:** 35332426 **Citation:** de Moraes FM, Brasil S, Frigieri G, Robba C, Paiva W, Silva GS. ICP wave morphology as a screening test to exclude intracranial hypertension in brain-injured patients: a non-invasive perspective. J Clin Monit Comput. 2024 Feb 14. doi: 10.1007/s10877-023-01120-3. Online ahead of print. **PMID:** 38355918 **Citation:** Brasil S, Solla DJF, Nogueira RC, Teixeira MJ, Malbouisson LMS, Paiva WDS. A Novel Noninvasive Technique for Intracranial Pressure Waveform Monitoring in Critical Care. J Pers Med. 2021 Dec 5;11(12):1302. doi: 10.3390/jpm11121302. **PMID:** 34945774 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000006259 - Term: Craniocerebral Trauma - ID: D000020196 - Term: Trauma, Nervous System ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5207 - Name: Brain Injuries - Relevance: HIGH - As Found: Brain Injury - ID: M628 - Name: Brain Injuries, Traumatic - Relevance: HIGH - As Found: Traumatic Brain Injury - ID: M17685 - Name: Wounds and Injuries - Relevance: HIGH - As Found: Injury - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M9349 - Name: Craniocerebral Trauma - Relevance: LOW - As Found: Unknown - ID: M22023 - Name: Trauma, Nervous System - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001930 - Term: Brain Injuries - ID: D000070642 - Term: Brain Injuries, Traumatic - ID: D000014947 - Term: Wounds and Injuries ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423456 **Brief Title:** Postoperative Pain Control Following Hysteroscopy **Official Title:** A New Alternative for Postoperative Pain Control Following Hysteroscopy;Preoperative Intravenous Lidocaine #### Organization Study ID Info **ID:** AFSU-OBGYN-BA-01 #### Organization **Class:** OTHER **Full Name:** Afyonkarahisar Health Sciences University ### Status Module #### Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Afyonkarahisar Health Sciences University #### Responsible Party **Investigator Affiliation:** Afyonkarahisar Health Sciences University **Investigator Full Name:** Betül Ahat **Investigator Title:** Assistant Doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False ### Description Module **Brief Summary:** Intraoperative lidocaine infusion is a frequently preferred method in surgical procedures due to its reducing the need for opioids, providing better postoperative pain control, reducing postoperative nausea and vomiting and increasing rapid recovery. Our aim in this study is to show the effect of intraoperative lidocaine infusion on reducing complications such as pain, nausea, vomiting, and the need for opioid analgesia that occur after hysteroscopy operations, which are often performed in gynecology clinics. **Detailed Description:** Hysteroscopy abnormal uterine bleeding, infertility, endometrial pathologies, uterine fibroids,it is a method that is often used in the diagnosis and treatment of pathologies such as intrauterine synechia. Hysteroscopy; observation of the inner layer of the uterus with a special optical instrument with a cold light source and it is the process of making intrauterine interventions using small hand tools. General anesthesia or with intrauterine fluid after dilating the cervix under regional (epidural/peridural) anesthesia it is filled and a thin telescope-like optical device (hysteroscope) is transmitted into the uterus. This way the uterine cavity is observed. Hysteroscopy is used for diagnostic purposes as well as for therapeutic purposes it can be applied. General Anesthesia (GA) is often the preferred method for operative hysteroscopy.Intraoperative lidocaine infusion reduces the need for opioids, postoperative pain control is better due to the fact that it reduces postoperative nausea, vomiting and increases rapid recovery, which is often preferred in surgical procedures. 150 patients who are scheduled to undergo hysteroscopy will be included in the study. Hysteroscopy the patients to be applied will be divided into two groups as research and control groups. To both groups 75 patients will be included each. General anesthesia during the procedure for patients in the research arm intravenous lidocaine of 0.15 ml/kg 1% will be administered intraoperatively before and during the procedure a 1% lidocaine infusion(at a dose of 0.2 ml/kg/hour) will be performed. In the control group, if 0.9% saline solution will be used instead of lidocaine. Pain measurement using visual analog scale (VAS) for postoperative pain after surgery will be done. At the same time, intraoperative analgesic use of patients, postoperative nausea-vomiting and antiemetic uses will be recorded. ### Conditions Module **Conditions:** - Postoperative Pain - Postoperative Nausea - Analgesia **Keywords:** - hysteroscopy - intraoperative lidocaine - postoperative pain - postoperative nausea ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Intraoperative lidocaine infusion is a frequently preferred method in surgical procedures due to its reducing the need for opioids, providing better postoperative pain control, reducing postoperative nausea and vomiting and increasing rapid recovery. Our aim in this study is to show the effect of intraoperative lidocaine infusion on reducing complications such as pain, nausea, vomiting, and the need for opioid analgesia that occur after hysteroscopy operations, which are often performed in gynecology clinics. ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 160 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** During the procedure, intravenous lidocaine of 0.15 ml/kg 1% will be administered intraoperatively before general anesthesia and infusion of lidocaine of 1%(at a dose of 0.2 ml/kg/hour) will be performed during the procedure. **Intervention Names:** - Drug: Lidocaine IV **Label:** Research group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** In the control group, 0.9% saline solution will be used instead of lidocaine. **Intervention Names:** - Drug: Saline **Label:** Control group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Research group **Description:** Pain measurement will be performed using a visual analog scale (VAS) for postoperative pain after the operation. At the same time, patients' intraoperative analgesic use, postoperative nausea-vomiting and antiemetic use will be recorded. **Name:** Lidocaine IV **Other Names:** - lidocaine HCl 2% **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Control group **Description:** Pain measurement will be performed using a visual analog scale (VAS) for postoperative pain after the operation. At the same time, patients' intraoperative analgesic use, postoperative nausea-vomiting and antiemetic use will be recorded. **Name:** Saline **Other Names:** - 0.09% Saline **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** After the hysteroscopy procedure is completed, in the postoperative anesthesia care room, postoperative, 30. and 60. in minutes, 4. per hour and 24. pain measurement will be performed for patients per hour using a visual analog scale (VAS) for postoperative pain. In this scale, patients' pain between 0-10 (0=no pain, 10=very severe pain) will be questioned. Dec. The doctor who performed the measurement will not know which drug infusion was made. NSAIDs will be administered to patients with a VAS score \> 4. Opioid analgesics will be administered to patients whose pain does not go away. At the same time, patients' intraoperative analgesic use, postoperative nausea-vomiting and antiemetic use will be recorded. **Measure:** Visual analog scale (VAS) **Time Frame:** 24 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Female patients with ASA I-II according to the American Society of Anesthesiologists (ASA) classification who are scheduled for elective hysteroscopy with indications such as * abnormal uterine bleeding * endometrial polyp * submucosal myoma * foreign body in the endometrial cavity * infertility * intrauterine synechia Exclusion Criteria: * Patients under the age of 18 * Who are allergic to lidocaine addicted to opioids or NSAIDs * Patients with chronic pain * Patients with severe systemic disease * Patients who do not approve **Gender Based:** True **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 19 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Betul Ahat **Phone:** +905467240341 **Role:** CONTACT #### Locations **Location 1:** **City:** Merkez **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Rıza Dur - **Phone:** +905326919591 - **Role:** CONTACT **Country:** Turkey **Facility:** Afyonkarahisar University of Health Science, school of medicine, hospital **State:** Afyonkarahi̇sar **Status:** RECRUITING **Zip:** 06330 #### Overall Officials **Official 1:** **Affiliation:** Afyonkarahisar University of Health Science, school of medicine **Name:** Betul Ahat **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Afyonkarahisar University of Health Science, school of medicine **Name:** Tuba Berra Sarıtaş **Role:** STUDY_CHAIR **Official 3:** **Affiliation:** Afyonkarahisar University of Health Science, school of medicine **Name:** Rıza Dur **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations - ID: D000012817 - Term: Signs and Symptoms, Digestive - ID: D000014839 - Term: Vomiting ### 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: M12273 - Name: Nausea - Relevance: HIGH - As Found: Nausea - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M17582 - Name: Vomiting - Relevance: LOW - As Found: Unknown - ID: M22074 - Name: Postoperative Nausea and Vomiting - Relevance: HIGH - As Found: Postoperative Nausea - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M15622 - Name: Signs and Symptoms, Digestive - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010149 - Term: Pain, Postoperative - ID: D000009325 - Term: Nausea - ID: D000020250 - Term: Postoperative Nausea and Vomiting ### Intervention Browse Module - Ancestors - ID: D000000779 - Term: Anesthetics, Local - ID: D000000777 - Term: Anesthetics - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000000889 - Term: Anti-Arrhythmia Agents - ID: D000061567 - Term: Voltage-Gated Sodium Channel Blockers - ID: D000026941 - Term: Sodium Channel Blockers - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: ChanBlk - Name: Channel Blockers - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: Analg - Name: Analgesics - Abbrev: AnEm - Name: Antiemetics - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M11014 - Name: Lidocaine - Relevance: HIGH - As Found: Solution - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M4251 - Name: Antiemetics - 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:** NCT06423443 **Brief Title:** Digital Cognitive Behavioral Therapy for Depressive Disorders **Official Title:** Digital Cognitive Behavioral Therapy for Depressive Disorders: A Randomized Controlled Trial #### Organization Study ID Info **ID:** ICBT2301 #### Organization **Class:** OTHER **Full Name:** Adai Technology (Beijing) Co., Ltd. ### Status Module #### Completion Date **Date:** 2025-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2023-12-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Adai Technology (Beijing) Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study aims to explore the effectiveness of digital interventions combined with medication in the treatment of patients with depressive disorders. Its main aim is to answer: Can digital interventions combined with medication effectively alleviate symptoms of depression? The experiment will compare the effects of medication combined with digital interventions to those combined with online mental health education to evaluate their relative effectiveness. Participants will be required to engage with the medication plus digital therapy for a duration of two months, and follow-up assessments will be conducted to evaluate the long-term effects of the treatments and monitor any changes in depressive symptoms. ### Conditions Module **Conditions:** - Depression - Anxiety ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 146 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: Digital Cognitive Behavioral Therapy - Drug: TAU **Label:** Digital Cognitive Behavioral Therapy **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Behavioral: Health Education - Drug: TAU **Label:** Health Education **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Digital Cognitive Behavioral Therapy **Description:** digital cognitive behavioral therapy app **Name:** Digital Cognitive Behavioral Therapy **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Health Education **Description:** traditional on-line health education app **Name:** Health Education **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - Digital Cognitive Behavioral Therapy - Health Education **Description:** treatment as usual **Name:** TAU **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Score Range: 0 (best outcome) to 60 (worst outcome) Higher scores indicate worse depression symptoms. **Measure:** Montgomery-Asberg Depression Rating Scale (MADRS) **Time Frame:** baseline and immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months #### Secondary Outcomes **Description:** PHQ-9 Score Range: 0 (best outcome) to 27 (worst outcome); higher scores indicate more severe depression symptoms. **Measure:** PHQ-9 (Patient Health Questionnaire-9) **Time Frame:** baseline and weekly assessments during the treatment period, assessed up to 8 weeks, and follow-ups at 4 weeks, 12 weeks, and 6 months **Description:** GAD-7 Score Range: 0 (best outcome) to 21 (worst outcome); higher scores indicate more severe generalized anxiety symptoms. **Measure:** GAD-7 (Generalized Anxiety Disorder-7) **Time Frame:** baseline and weekly assessments during the treatment period, assessed up to 8 weeks, and follow-ups at 4 weeks, 12 weeks, and 6 months **Description:** Score Range: 14 (best outcome) to 56 (worst outcome) Higher scores indicate greater levels of anhedonia (reduced ability to experience pleasure). **Measure:** Snaith-Hamilton Pleasure Scale (SHAPS) **Time Frame:** baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months **Description:** Score Range: 22 (best outcome) to 88 (worst outcome) Higher scores indicate higher levels of rumination. **Measure:** Rumination Response Scale (RRS) **Time Frame:** baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months **Description:** Score Range: 0 (best outcome) to 21 (worst outcome) Higher scores indicate poorer sleep quality. **Measure:** Pittsburgh Sleep Quality Index (PSQI) **Time Frame:** baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Meets the diagnostic criteria for depression according to the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), without psychotic symptoms, as recurrent outpatient or inpatient. 2. Patients with a Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 22 before randomization. 3. Age ≥ 18 and ≤ 65 years, regardless of gender. 4. Understands the trial and signs the informed consent form. Exclusion Criteria: 1. Meets criteria for other psychiatric disorders according to the DSM-5, including schizophrenia spectrum disorders, bipolar and related disorders, neurodevelopmental disorders, neurocognitive disorders, or depression due to substance and/or medication or other medical conditions. 2. History of substance and/or alcohol abuse within the past year. 3. Significant risk of suicide (MADRS item 10 score = 4). 4. Difficulty or inability to communicate verbally, understand or follow instructions, or cooperate with treatment and assessment. 5. Inability to use a smartphone. 6. Deemed unsuitable for participation by the researcher. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Liqun Zhang **Phone:** 010-85795371 **Role:** CONTACT #### Locations **Location 1:** **City:** Chengdu **Contacts:** ***Contact 1:*** - **Name:** Liqun Zhang - **Role:** CONTACT **Country:** China **Facility:** West China Hospital **State:** Sichuang **Status:** RECRUITING ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depressive Disorder - ID: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003866 - Term: Depressive Disorder ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423430 **Acronym:** TRANSCEND **Brief Title:** Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND) **Official Title:** Treatment ResistAnt Depression Subcallosal CingulatE Network DBS #### Organization Study ID Info **ID:** ABT-CIP-10494 #### Organization **Class:** INDUSTRY **Full Name:** Abbott Medical Devices ### Status Module #### Completion Date **Date:** 2029-04 **Type:** ESTIMATED #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-02 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-04 **Type:** ESTIMATED #### Start Date **Date:** 2024-08 **Type:** ESTIMATED **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Abbott Medical Devices #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this clinical trial is to evaluate the effectiveness and safety of bilateral stimulation of the subcallosal cingulate white matter (SCCwm) using Deep Brain Stimulation (DBS) as an adjunctive treatment of non-psychotic unipolar Major Depressive Disorder (MDD) in adults. **Detailed Description:** The aim of this prospective, multi-centered, double-blind, randomized, delayed-stimulation/ Sham-stimulation controlled 12-month study is to evaluate the effectiveness and safety of bilateral stimulation of the subcallosal cingulate white matter (SCCwm) using the Infinity™ Deep Brain Stimulation (DBS) system as an adjunctive treatment of non-psychotic unipolar Major Depressive Disorder (MDD) for adults who are experiencing a Major Depressive Episode (MDE) with inadequate response to 4 or more antidepressant treatments. In a double-blind fashion, half the subjects will receive active DBS therapy, while half will receive sham stimulation. After the 12-month endpoint, all subjects will be unblinded to their treatment group, and subjects in the control arm will receive active DBS therapy. ### Conditions Module **Conditions:** - Treatment Resistant Depression **Keywords:** - DBS - Major Depressive Disorder - Bilateral Stimulation - Antidepressant Treatment - neurostimulation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Group will be implanted with DBS system but device is not activated for the first 12 months. After 12 months, this group can receive stimulation. **Intervention Names:** - Device: Sham-stimulation **Label:** Sham-stimulation group **Type:** SHAM_COMPARATOR #### Arm Group 2 **Description:** Group will have DBS system activated 2 weeks post-implant. **Intervention Names:** - Device: Active-stimulation **Label:** Active-stimulation group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Sham-stimulation group **Description:** Sham-stimulation **Name:** Sham-stimulation **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Active-stimulation group **Description:** Active DBS **Name:** Active-stimulation **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The number of months in response divided by the total available months within the endpoint evaluation period. Response is defined as having at least a 50% reduction from baseline in MADRS total score **Measure:** Montgomery Asberg Depression Rating Scale (MADRS) Rate of Response **Time Frame:** 12 months #### Secondary Outcomes **Description:** Defined as ≥ 50% decrease in MADRS from baseline. **Measure:** MADRS Response Rates **Time Frame:** 12 months **Description:** Change in MADRS score over time **Measure:** Change in MADRS Score **Time Frame:** 12 months **Description:** Measured by MADRS, score ≤ 9 **Measure:** MADRS Remission Rates **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: The patient must be diagnosed with non-psychotic unipolar Major Depressive Disorder. The patient must be in a major depressive episode for ≥ 12 months or have had at least 3 lifetime depressive episodes. The patient has tried and failed a minimum of four different types of antidepressant treatments as measured by a tool designed for this purpose. Depression medication and treatment regimen must be stable for a minimum of 4 weeks before the first baseline visit Exclusion Criteria: Pregnant or those who plan to become pregnant during study Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that could limit participation in the study or interfere with adherence to the study protocol. Current or lifetime history of psychotic features in any Major Depressive Episode. Has an intracranial Central Nervous System disease that impairs motor, sensory or cognitive function or that requires intermittent or chronic medication. Significant acute suicide risk. Diagnosis of Substance Use Disorder or Alcohol Use Disorder without sustained remission (12 months or longer). Current and ongoing use of neurostimulation treatment that may interfere with DBS therapy/system. Treatment with another investigational device or investigational drugs. **Maximum Age:** 70 Years **Minimum Age:** 22 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Bradley White **Phone:** +6164432812 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Lyndahl Himes **Role:** CONTACT #### Locations **Location 1:** **City:** Los Angeles **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Sobell, Janet Laurie - **Phone:** 213-740-6000 - **Role:** CONTACT ***Contact 2:*** - **Name:** Adam Frank, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** USC University Hospital **State:** California **Zip:** 90033 **Location 2:** **City:** Los Angeles **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Broida Angela - **Phone:** 206-850-7392 - **Role:** CONTACT ***Contact 2:*** - **Name:** Andrew Leuchter, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** UCLA Department of Psychiatry **State:** California **Zip:** 90095 **Location 3:** **City:** Sacramento **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Beatty Jessica Anne - **Role:** CONTACT ***Contact 2:*** - **Name:** David Brandman, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of California at Davis **State:** California **Zip:** 95817 **Location 4:** **City:** Tampa **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yvonne Bannon - **Phone:** 813-974-2832 - **Role:** CONTACT ***Contact 2:*** - **Name:** Ryan Wagoner, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** USF Health **State:** Florida **Zip:** 33613 **Location 5:** **City:** Atlanta **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Sinead Quinn - **Phone:** 404-727-9228 - **Role:** CONTACT ***Contact 2:*** - **Name:** Patricio Riva Posse, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Emory University Hospital **State:** Georgia **Zip:** 30322 **Location 6:** **City:** Chicago **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Karen Neimanas - **Phone:** 312-563-2595 - **Role:** CONTACT ***Contact 2:*** - **Name:** John Zajecka, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Rush University Medical Center **State:** Illinois **Zip:** 60612 **Location 7:** **City:** Boston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Darin Dougherty, MD - **Phone:** 617-724-6143 - **Role:** CONTACT ***Contact 2:*** - **Name:** Darin Dougherty, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Massachusetts General Hospital **State:** Massachusetts **Zip:** 02114 **Location 8:** **City:** Boston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Anna George, RC - **Role:** CONTACT ***Contact 2:*** - **Name:** Joshua Aronson, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Beth Israel Deaconess Medical Center **State:** Massachusetts **Zip:** 02215 **Location 9:** **City:** Minneapolis **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** alik Widge, MD - **Phone:** 612-625-7594 - **Role:** CONTACT ***Contact 2:*** - **Name:** Alik Widge, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of Minnesota Medical Center Fairview **State:** Minnesota **Zip:** 55455 **Location 10:** **City:** Rochester **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Becca Ranfranz - **Role:** CONTACT ***Contact 2:*** - **Name:** Kendall Lee, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Mayo Clinic **State:** Minnesota **Zip:** 55905 **Location 11:** **City:** Saint Louis **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Britt Gott - **Phone:** 314-362-2463 - **Role:** CONTACT ***Contact 2:*** - **Name:** Charles Conway, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Washington University School of Medicine **State:** Missouri **Zip:** 63110 **Location 12:** **City:** New Brunswick **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Sherri Gzemski - **Role:** CONTACT ***Contact 2:*** - **Name:** Robert Gross, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Robert Wood Johnson University Hospital **State:** New Jersey **Zip:** 08901 **Location 13:** **City:** New York **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Laureen Pagan - **Role:** CONTACT ***Contact 2:*** - **Name:** Martijn Figee, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Mount Sinai Hospital **State:** New York **Zip:** 10019 **Location 14:** **City:** Cleveland **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Brian Barnett, MD - **Phone:** 216-636-5860 - **Role:** CONTACT ***Contact 2:*** - **Name:** Brian Barnett, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** The Cleveland Clinic Foundation **State:** Ohio **Zip:** 44195 **Location 15:** **City:** Philadelphia **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Marie Kerr - **Phone:** 215-829-6720 - **Role:** CONTACT ***Contact 2:*** - **Name:** Casey Halpern, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Hospital of the University of Pennsylvania **State:** Pennsylvania **Zip:** 19104 **Location 16:** **City:** Charleston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Morgan Dancy - **Phone:** 843-876-5141 - **Role:** CONTACT ***Contact 2:*** - **Name:** Mark George, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Medical University of South Carolina **State:** South Carolina **Zip:** 29425 **Location 17:** **City:** Dallas **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Hila Abush Segev - **Phone:** 214-648-0401 - **Role:** CONTACT ***Contact 2:*** - **Name:** Kala Bailey, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of Texas Southwestern Medical Center at Dallas **State:** Texas **Zip:** 75390 **Location 18:** **City:** Houston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Julia Page - **Phone:** 713-798-1075 - **Role:** CONTACT ***Contact 2:*** - **Name:** Sanjay Mathew, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** CHI St. Luke's Health Baylor College of Medicine Med. Ctr **State:** Texas **Zip:** 77030 **Location 19:** **City:** Houston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Amber Behne - **Role:** CONTACT ***Contact 2:*** - **Name:** Amir Faraji, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** The Methodist Hospital **State:** Texas **Zip:** 77030 **Location 20:** **City:** Salt Lake City **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Sarah Kwon - **Phone:** 801-829-7382 - **Role:** CONTACT ***Contact 2:*** - **Name:** Brian Mickey, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of Utah Hospital **State:** Utah **Zip:** 84132 #### Overall Officials **Official 1:** **Affiliation:** MOUNT SINAI HOSPITAL **Name:** Brian Kopell, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Medical University of South Carolina **Name:** Mark George, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depression - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M7060 - Name: Depressive Disorder, Major - Relevance: LOW - As Found: Unknown - ID: M29783 - Name: Depressive Disorder, Treatment-Resistant - Relevance: HIGH - As Found: Treatment Resistant Depression - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003863 - Term: Depression - ID: D000003866 - Term: Depressive Disorder - ID: D000061218 - Term: Depressive Disorder, Treatment-Resistant ### Intervention Browse Module - Browse Branches - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4247 - Name: Antidepressive Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423417 **Brief Title:** RCT: the Effectiveness of LifeHack in Improving Mental Wellbeing in University Students. **Official Title:** LifeHack: RCT Evaluating the Effectiveness of a Guided E-health Programme in Improving Mental Wellbeing in University Students. #### Organization Study ID Info **ID:** 2023-10-30-S.vanLuenen-V1-506 #### Organization **Class:** OTHER **Full Name:** Universiteit Leiden ### Status Module #### Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2023-11-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Maastricht University **Class:** OTHER **Name:** VU University of Amsterdam **Class:** OTHER **Name:** Utrecht University **Class:** OTHER **Name:** University of Amsterdam **Class:** OTHER **Name:** Rotterdam University of Applied Sciences **Class:** OTHER **Name:** Erasmus University Rotterdam **Class:** UNKNOWN **Name:** Avans University of applied sciences **Class:** UNKNOWN **Name:** InHolland University of Applied Sciences #### Lead Sponsor **Class:** OTHER **Name:** Universiteit Leiden #### Responsible Party **Investigator Affiliation:** Universiteit Leiden **Investigator Full Name:** Sanne van Luenen **Investigator Title:** assistant professor in the Clinical Psychology unit at the Institute of Psychology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Psychological issues are common among university students and affect mental wellbeing. The Caring Universities (CU) project, involving nine Dutch universities, aims to enhance students' mental health through an annual online questionnaire and a platform offering guided eHealth interventions. One intervention, LifeHack, utilizes cognitive behavioral therapy-based modules to improve mental wellbeing by enhancing resilience and life skills. The effects of LifeHack with pre-post measurements (total n = 216 at post-test) found found that LifeHack led to improvements in mental wellbeing, but dropout rates were influenced by lack of motivation and module relevance. A personalized version of LifeHack is being developed to address these issues and will be evaluated in an RCT to assess its effectiveness in improving mental wellbeing and related outcomes among university students. **Detailed Description:** Psychological problems are prevalent among university students and are associated with lower mental wellbeing and resilience. Universities provide an excellent environment for students to enhance mental wellbeing, resilience, and acquire life skills. Caring Universities (CU) is an internationally embedded consortium of nine Dutch universities aimed at improving students' mental wellbeing. The CU project consists of two components: 1) an annual online questionnaire assessing students' mental health; and 2) a platform offering free, guided eHealth interventions to enhance mental well-being. One of the interventions on the CU platform - called LifeHack - seeks to enhance mental wellbeing by increasing resilience, teaching life skills, and strengthening mental wellbeing. LifeHack is a guided eHealth intervention based on cognitive behavioural therapy, comprising 13 modules of approximately 30 minutes each focusing on four themes (mood management, productivity, self-worth, and relationships). We investigated the effects of LifeHack with pre-post measurements (total n = 216 at post-test) and found that after following LifeHack, mental wellbeing improved with small to moderate effect sizes. Additionally, students reported satisfaction with the programme and the eCoach. However, participants indicated lack of motivation and early symptom reduction as important reasons for drop-out. Furthermore, the diverse topics covered in LifeHack may not be relevant to all students, leading to more dropouts. Currently, there are two versions of LifeHack: one 'structured', where modules must be completed in order, and one 'free choice', where all modules are available from the start and none are mandatory. For the proposed study, the free choice version of LifeHack will be used and adapted in co-creation with students as follows: participants will be asked which topics they find most important and want to work on. Based on their answers, a personalized selection of modules will be presented, and students can choose which module to start with. Each module is standalone, allowing students to proceed to another module or stop after completing one or more. Each module has a clear structure, beginning with goal formulation and concluding with an action plan. The new adapted version of LifeHack will be personalized and tailored for each student, aiming to improve motivation and reduce dropout rates. With the current study, we aim to examine the effectiveness of the adapted version of LifeHack in an RCT to enhance mental wellbeing in university students. Secondary objectives include investigating differences between the intervention and control groups on students' self-report questionnaire resilience scores, depression scores, anxiety scores, stress-related scores, and mental health quality of life scores (pretest vs post-test). Additional outcomes include satisfaction with the programme and the eCoach, as well as adherence to the intervention. ### Conditions Module **Conditions:** - Internet-based Intervention - Waiting List Control Group - Depression - Anxiety - Stress - Quality of Life - Mental Wellbeing - Resilience ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The present study is a two-arm randomized controlled superiority trial. This trial will be conducted in a university setting. A guided web-based resilience and mental wellbeing programme (LifeHack) will be compared to a waiting list condition. Participants in the waiting list condition will start with the programme 4 weeks after randomization. ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 217 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** LifeHack is a guided (weekly feedback by a coach is provided) e-heath self-help application, which is based on cognitive behavioral techniques. The goal of LifeHack is to improve mental wellbeing. The guided internet-based self-help programme LifeHack was developed based on existing literature and adapted in collaboration with university students. The programme comprises twelve modules that are delivered via computer, laptop, tablet, or mobile phone. The modules take approximately 30 minutes on 4 themes (mood management, productivity, self-worth and relationships). Guidance: E-coaches will be trained clinical psychology master students. E-coaches will provide asynchronous written personalized feedback to each participant through the program platform within 48 hours (counting workdays only) after session completion. The aim of the written feedback is to increase motivation and adherence of the participants. **Intervention Names:** - Behavioral: LifeHack **Label:** LifeHack **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants in the waiting list control condition will start with the programme 4 weeks after randomization. **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - LifeHack **Description:** See arm description **Name:** LifeHack **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** Patient Health Questionnaire - 4 (Kroenke et al., 2009). After each module, the PHQ-4 will be assessed in both groups. **Measure:** Depression and anxiety (PHQ-4) after each module. **Time Frame:** After each module (approximately once per week) **Description:** The Client Satisfaction Questionnaire, CSQ-8 (Larsen et al., 1979) **Measure:** Client satisfaction (CSQ-8) **Time Frame:** 4 weeks post-baseline active group and 4 weeks post-T2 wait list group. **Description:** We will also ask participants to evaluate the e-coach at the post-test. The questions about e-coach evaluation will be based on the Working Alliance Inventory for Guided Internet Interventions (WAI-I) (Gómez Penedo et al., 2020) **Measure:** E-coach evaluation (WAI-I) **Time Frame:** 4 weeks post-baseline active group and 4 weeks post-T2 wait list group. **Description:** Adherence will be measured by the total number of completed sessions, time spent on the platform, and the number of logins. **Measure:** Adherence (Log info) **Time Frame:** T1 (4 weeks post-baseline active group), T2 (4 weeks post-baseline wait list group), T3 (4 weeks post-T2 wait list group), T4 (6 months post-baseline both groups) #### Primary Outcomes **Description:** Mental Health Continuum-Short Form, MHC-SF (Lamers et al., 2011). **Measure:** Mental wellbeing (MHC-SF) **Time Frame:** T0 (baseline), T1 (4 weeks post-baseline active group), T2 (4 weeks post-baseline wait list group), T3 (4 weeks post-T2 wait list group), T4 (6 months post-baseline both groups) #### Secondary Outcomes **Description:** Brief Resilience Scale (Smith et al., 2008). **Measure:** Resilience (BRS) **Time Frame:** T0 (baseline), T1 (4 weeks post-baseline active group), T2 (4 weeks post-baseline wait list group), T3 (4 weeks post-T2 wait list group), T4 (6 months post-baseline both groups) **Description:** Patient Health Questionnaire - 9, PHQ-9 (Kroenke et al., 2001). **Measure:** Depressive symptoms (PHQ-9) **Time Frame:** T0 (baseline), T1 (4 weeks post-baseline active group), T2 (4 weeks post-baseline wait list group), T3 (4 weeks post-T2 wait list group), T4 (6 months post-baseline both groups) **Description:** Perceived Stress Scale-10, PSS-10 (Cohen, 1988). **Measure:** Stress related symptoms (PSS-10) **Time Frame:** T0 (baseline), T1 (4 weeks post-baseline active group), T2 (4 weeks post-baseline wait list group), T3 (4 weeks post-T2 wait list group), T4 (6 months post-baseline both groups) **Description:** Generalized Anxiety Disorder-7 scale, GAD-7 (Spitzer et al., 2006). **Measure:** Symptoms of anxiety (GAD-7) **Time Frame:** T0 (baseline), T1 (4 weeks post-baseline active group), T2 (4 weeks post-baseline wait list group), T3 (4 weeks post-T2 wait list group), T4 (6 months post-baseline both groups) **Description:** Mental Health Quality of Life questionnaire, MHQoL (Krugten et al., 2022). **Measure:** Quality of life (MHQoL) **Time Frame:** T0 (baseline), T1 (4 weeks post-baseline active group), T2 (4 weeks post-baseline wait list group), T3 (4 weeks post-T2 wait list group), T4 (6 months post-baseline both groups) **Description:** E.g. gender, age, nationality **Measure:** Demographics **Time Frame:** T0 (baseline) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Being fluent in Dutch and/or English * Being enrolled as a student at one of the 9 participating universities * Being 16 years of age or older * Having access to a PC or mobile device with internet access * Provide informed consent before participation * Score of 50 or lower on the MHC-SF. This is 1 SD above the mean baseline score of participants of LifeHack. This inclusion criterion ensures no students with optimal mental wellbeing are included because they will not be able to show any change. **Healthy Volunteers:** True **Maximum Age:** 99 Years **Minimum Age:** 16 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Sanne van Luenen, PhD **Phone:** 0031-715277957 **Role:** CONTACT #### Locations **Location 1:** **City:** Amsterdam **Contacts:** ***Contact 1:*** - **Name:** Sanne van Luenen - **Role:** CONTACT **Country:** Netherlands **Facility:** VU Amsterdam **Status:** RECRUITING **Location 2:** **City:** Leiden **Contacts:** ***Contact 1:*** - **Name:** Sanne van Luenen - **Role:** CONTACT **Country:** Netherlands **Facility:** Leiden University **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Leiden University **Name:** Sanne van Luenen, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423404 **Brief Title:** Active Breaks on Mental Health and Classroom Climate in Chilean Schoolchildren Aged 6 to 10 **Official Title:** Video-Guided Active Breaks With Curricular Content on Mental Health and Classroom Climate in Chilean Schoolchildren Aged 6 to 10: Study Protocol for a Multicentre Randomized Controlled Trial #### Organization Study ID Info **ID:** Universidad de Concepción #### Organization **Class:** OTHER **Full Name:** Universidad de Concepcion ### Status Module #### Completion Date **Date:** 2024-08-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2024-08-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-04-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universidad de Concepcion #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Background: The incidence of mental health issues in children is increasing worldwide. In Chile, a recent surge in reports of deteriorating mental health among school populations and an increase in complaints related to poor school climate have been observed. Physical activity, specifically active breaks in the classroom, has shown positive effects on children's health. However, evidence regarding its impact on mental health and school climate in children is limited. Objective: This article outlines the design, measurements, intervention program, and potential efficacy of the Active Classes + School Climate and Mental Health project. This project will assess a 12-week program of active breaks through guided videos with curricular content in the school classroom, and its effects on mental health and school climate as its primary contributions. Additionally, it will measure physical activity, physical fitness, motor competence, and academic performance in students aged 6 to 10 years in the Biobío province, Chile, as secondary contributions. Methodology: It will be performed a multicenter randomized controlled trial involving students in the 1st to 4th grade (6 to 10 years old), encompassing a total of 48 classes across six schools (three intervention and three control) in the Biobío region, Chile. Video-guided active breaks will be implemented through the Active Classes; web platform, featuring curricular content, lasting 5 to 10 minutes and of moderate to vigorous intensity physical activity, twice a day, Monday to Friday, over a span of 12 weeks. Expected Results/Discussion: To our knowledge, this will be the first study in Chile to evaluate the effects of incorporating video-guided active breaks with curricular content on mental health variables and school climate in schoolchildren. Thus, this study contributes to the scarce evidence on the effects of video-guided active breaks on mental health variables and school climate in schoolchildren worldwide. Additionally, it will provide crucial information about active teaching methodologies that have the potential to positively contribute to the well-being of students, thus addressing the problems of mental health and climate in Chilean schools. ### Conditions Module **Conditions:** - Mental Health - School-age Children - School Health **Keywords:** - active break - mental health - school climate - schoolchildren - physical fitness - multicentre randomized controlled trial ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The project involves public primary schools with similar indices of school vulnerability (SVI) and medium to low socioeconomic status in the Biobío province, Chile. This selection was made because students attending these schools spend approximately eight hours per day (from 8:00 AM to 4:00 PM) with two 30-minute breaks and a longer one-hour lunch break. The intervention will focus on 1st to 4th grade classes. Six schools (three treatments and three controls) were recruited, estimating a sample size of 700 students (six schools × eight classes, with each class having 30 to 40 students). ##### Masking Info **Masking:** DOUBLE **Masking Description:** After schools agreed to participate, they were randomly assigned using a sequence generated by the IBM SPSS statistical package, with concealed allocation to one of two groups: 1) the Experimental Group (n=3), receiving a 12-week program of video-guided active breaks with curricular content in the school classroom; and 2) the Control Group (n=3), receiving the same intervention as the experimental group after the final data collection. A simple stratified randomization sequence by sex was used to achieve balance between males and females in both groups. The randomization sequence will be concealed through sequentially numbered, opaque, sealed envelopes, conduct by a project investigator with no contact with schools and participants. Significant differences in the quality of life, motor skills, and academic performance have been found in studies with similar samples. **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 700 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The Experimental Group, receiving a 12-week program of video-guided active breaks with curricular content in the school classroom **Intervention Names:** - Behavioral: the Experimental Group, receiving a 12-week program of video-guided active breaks with curricular content in the school classroom **Label:** Experimental Group: Active Break group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The Control Group, receiving the same intervention as the experimental group after the final data collection. During the time of the intervention, the waiting list group will receive the usual classes. **Intervention Names:** - Behavioral: the Experimental Group, receiving a 12-week program of video-guided active breaks with curricular content in the school classroom **Label:** Control group: waiting list group **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Control group: waiting list group - Experimental Group: Active Break group **Description:** The \&#34;Active Classes + School Climate and Mental Health\&#34; program was crafted following a comprehensive review by the research team on active breaks in the child school population. Based on the findings of this review, the optimal type and duration of intervention, frequency and intensity of the most effective exercises, and video-guided modalities with curricular content for active breaks will be established. Subsequently, a collaborative network was formed, involving researchers from education, sports science, social sciences, medicine, primary school teachers within the Chilean public school system, teams of educational leaders, parents, guardians, pedagogy students, and graduate students. The purpose was to create a team that systematically supports the development of various stages of the project from a multi and interdisciplinary perspective **Name:** the Experimental Group, receiving a 12-week program of video-guided active breaks with curricular content in the school classroom **Other Names:** - active break program **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** The sociodemographic instrument includes information related to characteristics of the students and their parents (i.e. economic level, educational level). In addition, physical activity and sedentary behavior, eating habits, sleeping and screen habits, type of transportation to the educational center. **Measure:** Sociodemographic **Time Frame:** From enrollment to the end of treatment at five months #### Primary Outcomes **Description:** School climate scale (ECLIS). 82 items with a four-level Likert-type response format (ranging from all to none). **Measure:** School climate **Time Frame:** From enrollment to the end of treatment at five months **Description:** This outcome will be measurement with School Self-Esteem Test (SSET) and Self-report of socioemotional well-being. The raw score sum is transformed into a T score according to age norms, categorizing students as follows: normal self-esteem, ≥ 40 points; low self-esteem, 30-39 points; and very low self-esteem, ≤ 29 points. **Measure:** Mental health **Time Frame:** From enrollment to the end of treatment at five months #### Secondary Outcomes **Description:** The academic performance of the students will be measured using Integral Learning Diagnosis. For this study, only the reading test (2nd, 3rd, and 4th grades) and mathematics test (3rd and 4th grades) were used, measured at the beginning and end of the school year. The grading scale is from 1 as a minimum value to 7 as a maximum value. **Measure:** Academic performance **Time Frame:** From enrollment to the end of treatment at five months **Description:** This outcome will be measurement using the Alpha Fitness Test battery protocol, which includes measurements of cardiorespiratory, musculoskeletal, and motor condition. **Measure:** Physical health **Time Frame:** From enrollment to the end of treatment at five months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: - a) Regular male or female students in primary education, from first to fourth grade, at a public school in one of the three provinces of the Biobío region, willing to participate and with parental consent. b) Students spend at least 38 hours per week in classes (6.5 hours daily) and have at least two short breaks (10-15 minutes) per day. Exclusion Criteria: * a) Students with a medical diagnosis of spinal pathologies, vertigo, or uncontrolled hypertension. b) Students with severe intellectual disabilities prevented them from following the program instructions. c) Students participating simultaneously in another project with similar objectives. **Healthy Volunteers:** True **Maximum Age:** 10 Years **Minimum Age:** 6 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Concepción **Country:** Chile **Facility:** Universidad de Concepción **State:** Biobio **Zip:** 4030000 **Location 2:** **City:** Concepción **Country:** Chile **Facility:** Universidad de Concepción **State:** Biobio **Zip:** 4070371 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Reyes-Amigo T, Ibarra-Mora J, Aguilar-Farias N, Gomez-Alvarez N, Carrasco-Beltran H, Zapata-Lamana R, Hurtado-Almonacid J, Paez-Herrera J, Yanez-Sepulveda R, Cortes G, Rolle-Caceres G, Bezerra A. An active break program (ACTIVA-MENTE) at elementary schools in Chile: study protocol for a pilot cluster randomized controlled trial. Front Public Health. 2024 Jan 8;11:1243592. doi: 10.3389/fpubh.2023.1243592. eCollection 2023. **PMID:** 38259740 ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423391 **Acronym:** NeuOst **Brief Title:** Multimodal Intervention for Painful Diabetic Neuropathy: NeuOst Feasibility Trial **Official Title:** A Multimodal Manual Therapy-Based Intervention for People With Painful Diabetic Neuropathy: Feasibility of a Randomised Controlled Efficacy Trial #### Organization Study ID Info **ID:** NeuOst feasib V 1.0 March 2024 #### Organization **Class:** OTHER **Full Name:** University College of Osteopathy ### Status Module #### Completion Date **Date:** 2024-11-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-10-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-30 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Imperial College London **Class:** OTHER **Name:** King's College London **Class:** OTHER **Name:** University of Oxford **Class:** OTHER **Name:** Universität Münster #### Lead Sponsor **Class:** OTHER **Name:** University College of Osteopathy #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is the feasibility study of a single-site parallel three-armed participant-blinded controlled randomised efficacy trial of a 5-week course of the 'NeuOst treatment', compared to a designated control intervention, and to usual care only, for adults with pDPN. **Detailed Description:** Eligible participants are adults diagnosed with diabetes and pDPN, as evaluated with clinical questionnaires during an initial telephone screening. Participants with foot ulcerations, amputations, and advanced organ failure are excluded. Twelve participants per arm (36 in total) will be recruited via social media, local print media, and a poster and leaflet campaign in relevant clinics. Blocked randomisation will allocate participants in a 1:1:1 ratio, using permuted block sizes. The test intervention consists of five weekly 1-hour sessions of semi-standardised augmented manual therapy with a specifically trained provider (NeuOst), in addition to participants' continued usual care. The control intervention will be specifically matched following current guidance, replicating the NeuOst intervention in all aspects except selected components which the study aims to investigate. Providers will be UK-registered osteopaths. Both test and control intervention were developed with extensive involvement of people with pDPN and practitioners. The third study arm will be a Usual Care (UC) group, consisting of baseline and follow-up assessments only. All trial participants can continue their usual care outside the trial, although participants will be asked to not alter their medication regimens or nonpharmacological management if possible. An independent combined steering \& data-monitoring committee (TSC/DMC) will monitor the trial throughout and include a stakeholder representative. Participants will be reimbursed for their travel expenses but not time. Screening and follow-up data collection will be conducted electronically or via the phone to minimise trial burden. The timepoints of follow-up are immediately after treatment completion, and at 8 and 16 weeks from randomisation. Key methodological and reporting guidance for feasibility trials will be followed, and a protocol pre-registered. Ethical approval was obtained from the institutional Research Ethics Committee. Feasibility of a definite trial will be judged according to pre-specified criteria regarding the primary feasibility outcomes following pre-specified progression rules: Recruitment, consent rates, treatment completion, retention rates, interventionist fidelity in treatment delivery, data completeness, treatment acceptability, blinding success, and adverse events. Secondary outcomes include measures of pain intensity, interference, and quality, sleep, quality of life, and fear of falling. The sample size of 36 was a pragmatic decision based on available funding and the trial is not powered to detect meaningful differences in clinical outcomes. Analysis of feasibility outcomes will be largely descriptive. For clinical outcomes, a pre-specified blinded analysis will provide estimates of changes in clinical outcome measures and their variance, modelling differently sized confidence intervals and presenting them as forest plot with the MCID indicated. This information can then be used for sample size calculations for a potential full-scale trial. Qualitative data from interviews with volunteering participants and trial interventionists will provide further nuance for progression decisions or intervention refinement. ### Conditions Module **Conditions:** - Painful Diabetic Neuropathy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** feasibility study of a single-site parallel three-armed participant-blinded controlled randomised trial ##### Masking Info **Masking:** TRIPLE **Masking Description:** The following stakeholders will be blinded to participants' group allocation in the test intervention and control intervention groups. Allocation to the Usual Care group will not be concealed from staff or participants, except for the trial statistician: * Trial participants (except in usual care arm) * Clinical support and administration staff * Outcome assessors (collecting data at end-of-treatment and follow-up) * Trial statistician * Provider blinding will not be possible as providers will have to actively deliver both the test and the control intervention. However, extensive pre-trial training and supervision during the trial will ensure that providers understand the purpose of the control intervention and are supported to deliver it with high fidelity. **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The tested treatment is a manual therapy-based intervention, drawing on core manual therapy components and integrating psychologically informed approaches to pain management and elements from diabetes education, foot care, and exercise rehabilitation. This intervention is called 'Augmented manual therapy for people with painful diabetic neuropathy', or NeuOst. NeuOst components will be taught to fully qualified UK-registered osteopaths who then deliver the intervention according to a treatment manual in 1:1 appointments, lasting 45-60 minutes each (90 mins first appointment). Up to 5 treatment sessions will be provided per patient, at weekly intervals and at maximum over 10n weeks. The treatment manual specifies obligatory and optional elements for each of the 5 study treatment sessions. Exercise components will be rehearsed in the clinic with providers. Participants will then be encouraged to complete a progressive home-exercise programme according to the manual. **Intervention Names:** - Other: NeuOst **Label:** Tested intervention (NeuOst treatment) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The objectives of the control intervention are to replicate the contextual elements of the test intervention (to test efficacy), and to blind participants to group allocation. Trial providers will be trained in its delivery. As per CoPPS guidance, the control intervention will resemble the tested intervention in all aspects but for the components whose effect the trial is designed to study. These excluded components of interest, and their respective adaptations in the control intervention, are specified in the detailed pre-registered protocol. Control intervention components will be taught to fully qualified UK-registered osteopaths who then deliver the intervention according to a treatment manual in 1:1 appointments, lasting 45-60 minutes each (90 mins first appointment). Up to 5 treatment sessions will be provided per patient, at weekly intervals and at maximum over 10 weeks. **Intervention Names:** - Other: Control Intervention **Label:** Control intervention **Type:** SHAM_COMPARATOR #### Arm Group 3 **Description:** Participants randomized to this study arm will only undergo baseline and follow-up assessments but will receive no further attention as part of this trial. As in all other trial arms, they are free to continue their usual medical care but will be encouraged to not change their analgesic regime or nonpharmacological management as far as possible. **Intervention Names:** - Other: Usual Care **Label:** Usual care comparator **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Tested intervention (NeuOst treatment) **Description:** As above **Name:** NeuOst **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Control intervention **Description:** As above **Name:** Control Intervention **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Usual care comparator **Description:** As above **Name:** Usual Care **Other Names:** - Treatment as Usual **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Patient's Global Impression of Change scale **Measure:** Global Impression of Change **Time Frame:** 5, 8, 16 weeks **Description:** Concomitant medication and intervention use via self-reported questionnaire **Measure:** Concomitant medication and intervention use **Time Frame:** 5, 8, 16 weeks **Description:** measured as number of days with 'bothersome' and 'intolerable' pain in past week **Measure:** Pain Bothersomeness **Time Frame:** 1, 2, 3, 4, 5, 8, 16 weeks **Description:** measured as number of days with 'intolerable' pain in past week **Measure:** Pain Intolerability **Time Frame:** 1, 2, 3, 4, 5, 8, 16 weeks **Description:** Participant feedback form and semi-structured interviews on NeuOst and trial-related aspects **Measure:** Participant experiences **Time Frame:** 16 weeks #### Primary Outcomes **Description:** Using pre-defined set of feasibility criteria, measuring recruitment, consent rates, treatment completion, retention rates, interventionist fidelity in treatment delivery, treatment acceptability, blinding success, data completeness, adverse events, and participant acceptability. **Measure:** Study Feasibility **Time Frame:** 12 months from recruitment start #### Secondary Outcomes **Description:** measured on the Brief Pain Inventory (Short Form) **Measure:** Pain intensity (average in past week) **Time Frame:** 1, 2, 3, 4, 5, 8, 16 weeks **Description:** measured on the Diabetic Peripheral Neuropathic Pain Impact (DPNPI) measure **Measure:** Impact of Diabetic Neuropathic Pain **Time Frame:** 5, 8, 16 weeks **Description:** Neuropathy- and foot ulcer-specific quality of life instrument (NeuroQoL) **Measure:** Neuropathy- and Foot Ulcer-Specific Quality of Life **Time Frame:** 5, 8, 16 weeks **Description:** Falls Efficacy Scale (FES-I, short form) **Measure:** Fear of Falling **Time Frame:** 5, 8, 16 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Medical diagnosis of diabetes mellitus (type 1 or type 2) as per patient self-report. * Distal symmetrical peripheral neuropathy (defined as a score of ≥4 on the Michigan Neuropathy Screening Instrument (questionnaire part) (Herman et al., 2012)). * Neuropathic pain as assessed by DN4 questionnaire (defined as a score of ≥3 of 7 self-reported items) (Spallone et al., 2012). * Stable analgesic medication regimen for at least 3 weeks prior to anticipated study enrolment and no revision of regimen planned within the next 3 months. * Stable attendance of out-of-study nonpharmacological therapies for neuropathic pain or professional exercise programmes (including gym classes and manual therapy) for at least 3 weeks prior to anticipated study enrolment and no revision of routine planned within the next 3 months. * Participants capable of giving informed consent themselves. * Participants able to speak, understand, and read English at conversational levels. * Age: 18 and older. Exclusion Criteria: * Contraindications to manual therapy and conservative pain management (as determined by recruiting staff during screening calls or the trial provider at the initial or any other appointment; May include medical emergencies and suspected severe pathology, advanced osteoporosis, and active foot ulcerations) * Past or scheduled amputations * Advanced renal failure * Recent physical trauma and suspected fracture * Currently experiencing severe depressive or other current and severe psychopathology such as bipolar/psychosis, and/or presenting with active suicidal risk * Carpal Tunnel Syndrome diagnosis or symptoms as the only source of neuropathic pain * Unable or unwilling to provide consent for study participation * Unable to attend in-person appointments at treatment site (for health reasons) * Unable to attend in-person appointments at treatment site (for organisational reasons) * Knowing other participants signed up to the study (to avoid group contamination) * Concomitant participation in another clinical intervention study * Changes in medication or physical activity programmes in the past 1 month or planned for the next 3 months. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** David Hohenschurz-Schmidt, PhD **Phone:** +44 (0)20 7089 5330 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Steven Vogel, DO **Phone:** +44 (0)20 7089 5330 **Role:** CONTACT #### Locations **Location 1:** **City:** London **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** David Hohenschurz-Schmidt, PhD - **Role:** CONTACT **Country:** United Kingdom **Facility:** University College of Osteopathy **Status:** RECRUITING **Zip:** SE1 1HX #### Overall Officials **Official 1:** **Affiliation:** University College of Osteopathy / Imperial College London **Name:** David Hohenschurz-Schmidt, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Anyone can access **Description:** The sharing of trial data, specifically anonymised individual patient data and summary data, is permissible once the final report of all analyses specified in this report has been published in a scientific journal. External parties can request access to this dataset or the dataset may be shared on an online repository (OSF.io). **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** Once the final report of all analyses specified in this report has been published in a scientific journal. **URL:** https://osf.io/sbqce/ ### References Module #### See Also Links **Label:** Full protocol (embargoed until Nov 2024) **URL:** https://osf.io/sbqce/ **Label:** Study website **URL:** https://www.uco.ac.uk/NeuOst ## Document Section ### Large Document Module #### Large Docs - Date: 2024-03-20 - Filename: ICF_000.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 120443 - Type Abbrev: ICF - Upload Date: 2024-05-08T16:00 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010523 - Term: Peripheral Nervous System Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009461 - Term: Neurologic Manifestations - ID: D000048909 - Term: Diabetes Complications - ID: D000003920 - Term: Diabetes Mellitus - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M7124 - Name: Diabetic Neuropathies - Relevance: HIGH - As Found: Diabetic Neuropathy - ID: M13066 - Name: Pain - Relevance: HIGH - As Found: Painful - ID: M13432 - Name: Peripheral Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M26004 - Name: Diabetes Complications - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003929 - Term: Diabetic Neuropathies - ID: D000010146 - Term: Pain ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423378 **Brief Title:** Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee **Official Title:** Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee #### Organization Study ID Info **ID:** OSSIOfiber Kneebar #### Organization **Class:** OTHER **Full Name:** Vanderbilt University Medical Center ### Status Module #### Completion Date **Date:** 2025-12-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-03 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Vanderbilt University Medical Center #### Responsible Party **Investigator Affiliation:** Vanderbilt University Medical Center **Investigator Full Name:** Lance LeClere **Investigator Title:** Dr. Lance LeClere, MD; Principal Investigator, Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The OSSIOfiber® Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis and bone grafts in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast, brace). Our hypothesis is that the use of OSSIOfiber® Trimmable Fixation Nails for treating subchondral insufficiency of the knee will result in improvement of patient-reported outcomes and imaging findings. The primary objective of this study is to evaluate the effectiveness of implanting bio-integrative OSSIOfiber® Trimmable Fixation Nails, organized in a bi-cortical rafter formation within the tibia or femur for the management of subchondral insufficiency. The OSSIOfiber® Trimmable Fixation Nails used in this study will be considered on-label. ### Conditions Module **Conditions:** - Subchondral Insufficiency Fracture ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Subjects will be treated with cannulated nails before or after arthroscopic management of their concomitant pathology at the discretion of the investigator. Technique described below. Following nail placement, tissue layers will be closed in standard fashion. 1. Preop MRI views used to estimate the proper depth \& location of nail placement on the femur and/or tibia 2. Exposure is gained to medial tibia 3. 1.4 mm K-Wire is placed through medial tibia parallel to the articular joint surface \~ 1 cm distal to the articular joint line 4. A depth gauge is placed over K-Wire to determine required length of cannulated nail 5. A 4.0 mm cannulated drill bit used over K-Wire to prepare the pilot hole 6. Tamp is used to insert pre-trimmed 4.0 mm cannulated nail into the pilot hole and K-Wire is subsequently removed 7. Intraop fluoroscopy can confirm adequate nail placement prior to removing K-wire 8. Repeat steps for additional nails **Name:** OSSIOfiber® Trimmable Fixation Nails **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The overall KOOS score combines pain and function domains. KOOS is out 100, where 0 equates to extreme pain and 100 equates to no pain. **Measure:** Knee injury and Osteoarthritis Outcome Score (KOOS) **Time Frame:** 3 months post-operatively **Description:** The overall KOOS score combines pain and function domains. KOOS is out 100, where 0 equates to extreme pain and 100 equates to no pain. **Measure:** Knee injury and Osteoarthritis Outcome Scale Score (KOOS) **Time Frame:** 6 months post-operatively #### Secondary Outcomes **Description:** Measures the knee health of individuals following surgery **Measure:** Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) **Time Frame:** 6 months post-operatively **Description:** IKDC measures: symptoms, athletic activity, and knee function. **Measure:** International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form **Time Frame:** 6 months post-operatively **Description:** VR-12 combines measures of general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, fatigue , social functioning, and mental health **Measure:** Veterans Rand-12 (VR-12) Health Survey Scale Score **Time Frame:** 6 months post-operatively **Description:** Measures a subject's perceived pain level. This score is usually on a scale of 0-10 with 0 equating to no pain and 10 equating to the worst pain imaginable. **Measure:** Numeric Pain Reported Scale Score **Time Frame:** 6 months post-operatively **Description:** Measures what level pain hinders a patient's engagement in several activities including social, cognitive, physical, and recreational activities. There are 7 sub items and each are rated from a scale of 0-10 where 0 means it does not interfere and 10 means it completely interferes. These contribute to a final score ranging anywhere from 0-70. **Measure:** PROMIS Pain Interference Score **Time Frame:** 6 months post-operatively **Description:** Measures self-reported negative mood (sadness, guilt), views of self (self- criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40. Higher scores indicate greater severity of depression. **Measure:** PROMIS Depression Score **Time Frame:** 6 months post-operatively **Description:** Measures the level of physical function for patients with a wide variety of impairments that may limit the patient's physical capability. This score is on a scale from 0-100 with 0 equating to no physical function and 100 equating to optimal physical function. **Measure:** PROMIS Physical Function Score **Time Frame:** 6 months post-operatively **Description:** Assessment of the incidence of re-operations, revision surgeries, or additional management of the study knee outside of postoperative rehabilitation. **Measure:** Incidence Assessments **Time Frame:** Up to 6 month post-operatively **Description:** To see how the knee ligament is healing by MRI assessment. **Measure:** Degree of knee ligament healing **Time Frame:** Baseline and 6 months post-operatively **Description:** Rate of postoperative adverse events and complications **Measure:** Adverse Events **Time Frame:** Up to 6 month post-operatively ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Agree to study participation and consent obtained. * Able to attend all postoperative clinical visits, undergo imaging procedures, and complete relevant questionnaires. * Subjects between the ages of 18 to 75 years. * Body Mass Index \< 40. * Has knee pain in the study knee lasting at least 3 months and has had at least moderate pain recorded on a standard of care (SOC) preoperative Knee Injury and Osteoarthritis Outcome Score (KOOS) and/or Numeric Pain Reported Scale (0-10) questionnaire. The study team may utilize these verbal pain scores collected during the clinic intake process for screening purposes. If the patient was not administered the verbal pain score, the patient will be consented, administered the pain survey, and withdrawn if moderate pain score was not recorded. * At least 3-months without steroid injection or any other non-surgical intervention administered to study knee. * Candidate for knee arthroscopy due to meniscal tear, loose body, unstable articular cartilage or mechanical symptoms. * Uni-compartmental Kellgren-Lawrence grade 2-3 osteoarthritis in the study tibia or femur. * Bone Marrow Lesion (BML) confirmed on magnetic resonance imaging in the femur, tibia or both. * Cartilage lesion on the tibial or femoral condyle(s) of a grading ≤4 by either the International Cartilage Repair Society or Outerbridge classifications verified at the time of arthroscopy. Exclusion Criteria: * Imaging evidence of the study knee that includes any of the following: 1. Kellgren-Lawrence grade 4 osteoarthritis. 2. Collapse of subchondral bone. 3. Avascular Necrosis (AVN). 4. Osteochondral defect overlying the BML 5. BML located at ACL or PCL insertions * Clinical evidence of the study knee that includes any of the following: 1. History of rheumatoid arthritis, septic arthritis, reactive arthritis, gout or pseudogout, secondary arthropathy (e.g., hemochromatosis, hemophilia, or psoriasis). 2. Osteochondritis dissecans. 3. Frank ligamentous instability. 4. Neuromuscular deficiency or other that would limit the ability to do a functional assessment. * Bi-cortical nail implantation cannot be achieved, including where the required nail length is not yet available. * Current tobacco use or has quit within 3 months of study enrolment. * Substance abuse history. * Diabetes mellitus, HbA1c\>8 * High surgical risk due to pre-existing conditions. * Currently pregnant or has plans to become pregnant prior to surgery. * Active infection or history of chronic infection in study knee. * Will require concomitant procedures within study knee, including but not limited to ligament reconstruction, tendon repair, meniscus repair, microfracture, osteotomy, or osteochondral transplantation (Meniscal tears, including chronic, are acceptable if no repair is required) * Significant malalignment (varus or valgus) of the knee (\>8°) * Use of augmentation or concomitant biologic therapy during surgery. * Contraindications to magnetic resonance imaging. * Any condition which in the view of the treating physician makes it inadvisable for the subject to participate in the study. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Lindsey Agnew, MS **Phone:** 6158751996 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000050723 - Term: Fractures, Bone - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M26370 - Name: Fractures, Bone - Relevance: LOW - As Found: Unknown - ID: M18332 - Name: Fractures, Stress - Relevance: HIGH - As Found: Insufficiency Fractures - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015775 - Term: Fractures, Stress ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423365 **Brief Title:** A Tool to Help Patients With Muscle Symptoms After Taking a Statin Medication. **Official Title:** Development, Testing, and Implementation of Virtual Statin Associated Muscle Symptom Management #### Organization Study ID Info **ID:** R01HL157439 **Link:** https://reporter.nih.gov/quickSearch/R01HL157439 **Type:** NIH #### Organization **Class:** OTHER **Full Name:** University of Utah ### Status Module #### Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-04-20 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Kaiser Permanente #### Lead Sponsor **Class:** OTHER **Name:** University of Utah #### Responsible Party **Investigator Affiliation:** University of Utah **Investigator Full Name:** Jordan King **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 clinical trial is to learn if an educational website can help patients make an informed decision and engage in shared decision-making with their healthcare provider regarding cholesterol lowering medication use after they have stopped statin therapy due to self-reported muscle symptoms from taking a statin medication. The main questions the trial aims to answer are: 1. Compared to usual care, are patients who engage with the website after experiencing statin-associated muscle symptoms (SAMS) more likely to retry statin therapy? 2. Compared to usual care, are patients who retry statin therapy after engaging with the website more likely to persist on statin therapy? Researchers will compare people randomized to use the website to those who are receiving usual care to see if statin re-start and persistence rates change. All participants will take baseline questionnaires and receive usual care as they would if they were not in the study (e.g., visit their doctor, get labs drawn, take medication as prescribed). Patients randomized to the website arm will be asked to engage with content in a website which is anticipated to take most patients approximately 30-minutes. Their clinician will then contact them for a follow-up visit as needed. ### Conditions Module **Conditions:** - Hydroxymethylglutaryl-CoA Reductase Inhibitors - Hypercholesterolemia - Cardiovascular Diseases - Pharmacists - Placebo Effect ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 816 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants randomized to usual care will continue to receive usual care at Kaiser Permanente Colorado as they would under normal, non-study conditions. **Label:** Usual care **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Participants randomized to usual care + virtual statin management (VSM) will continue to receive usual care at Kaiser Permanente Colorado as they would under normal, non-study conditions, and they will also be given a link to engage with the VSM website. The VSM website is an educational tool which has four principal components: 1) learning how to distinguish if and when muscle symptoms are caused by the statin; 2) learning the essentials about heart disease, focusing on causes, risk factors, and the crucial role of cholesterol management in prevention; exploring various cholesterol lowering options, including when it makes sense to retry a statin and what options exist beyond statins; and 4) learning to engage in productive discussions with healthcare providers and set effective treatment goals together. **Intervention Names:** - Other: Virtual Statin Management (VSM) **Label:** Usual Care + Virtual Statin Management (VSM) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Usual Care + Virtual Statin Management (VSM) **Description:** VSM is a web-based decision aid to help manage statin therapy after experiencing muscle pain perceived to be caused or worsened by their statin therapy. The introduction will feature a brief explanation of the tool and what they can expect. The modules are: 1. General education (lipids, heart disease, medications) 2. Side effects (causes, diagnosis). 3. Statin modifications. VSM will guide patients to understand their lipid-lowering options, particularly their statin options that may best match patients' stated preferences. 4. ASCVD risk \& statin benefit. Finally, the VSM experience will end by providing the patient with a summary of the results of their use of the tool, which can be used during discussions with their healthcare provider. The information gathered from the VSM will remain confidential and will not be disclosed to anyone other than the patient. **Name:** Virtual Statin Management (VSM) **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Assessed using two questions inspired by the Treatment Satisfaction with Medication Questionnaire. Participants the degree to which they agree or disagree (5-point Likert) regarding their satisfaction with cholesterol-lowering medication. **Measure:** Proportion of participants satisfied with their treatment **Time Frame:** 6 months post-enrollment **Description:** Assessed using the Decisional Conflict Scale, 10-item, 3-response (https://decisionaid.ohri.ca/docs/develop/Tools/DCS_LowLiteracy_English.pdf). Participants indicate "yes", "unsure", or "no" to 10 questions assessing their decisional conflict regarding their decision to use cholesterol-lowering medication. **Measure:** Participant-reported decisional conflict **Time Frame:** 1 month post-enrollment **Description:** Measured using the Decision Self-Efficacy Scale, 11-item, 3-response (https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decision_SelfEfficacy.pdf). Participants indicate their level of confidence from 0 (not at all confident) to 4 (very confident) regarding their decision to use cholesterol-lowering medication. **Measure:** Participant-reported decision self-efficacy **Time Frame:** 6 months post-enrollment **Description:** Adapted from 3 questions used in the Prospective Assessment of Lipid Management (PALM) registry (https://classic.clinicaltrials.gov/ct2/show/NCT02341664). Participants indicate their perceived risk for having a heart disease event. **Measure:** Participant-reported perception of cardiovascular disease risk **Time Frame:** 6 months post-enrollment **Description:** Measured using the Trust in Physician Scale, 11-item (https://pubmed.ncbi.nlm.nih.gov/2084735/). Participants indicate the degree to which they agree or disagree (5-point Likert scale) with statements regarding their trust in healthcare personnel. **Measure:** Participant-reported degree of trust in healthcare **Time Frame:** 6 months post-enrollment **Description:** Participants indicate the degree to which they agree or disagree with 18 statements regarding potential statin-related harms or conspiracies. Answer options of strongly disagree, disagree, neither agree nor disagree, agree, strongly agree, or Not sure. Agreement with the statement indicates a negative belief about statins. **Measure:** Participant-reported statin conspiracy beliefs **Time Frame:** 6 months post-enrollment **Description:** Measured using the Decision Regret Scale, 5-item, 5-response (https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Regret_Scale.pdf). Participant indicate the degree to which they agree or disagree (5-point Likert Scale) with 5 statements regarding their choice to use cholesterol-lowering medication. **Measure:** Participant-reported decision regret **Time Frame:** 6 months post-enrollment #### Primary Outcomes **Description:** Measured using pharmacy dispensing records **Measure:** Number of participants who retry statin therapy **Time Frame:** 30 days post-enrollment **Description:** Measured using pharmacy dispensing records **Measure:** Number of participants who continue to take statin therapy **Time Frame:** 6 months post-enrollment #### Secondary Outcomes **Description:** Measured using pharmacy dispensing records, using the proportion of days' covered calculation metric (range: 0-100%, where 100% means perfectly adherent) **Measure:** How adherent participants are to prescribed statin therapy **Time Frame:** 6 months post-enrollment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * KPCO member * Sold a statin from KPCO pharmacy in the previous six months * Have a gap of \>1.0x the days' supply in refilling their statin * Patient who stopped therapy (or delayed filling prescription) due to some perceived side effect * Has email address available in kp.org (and therefore has access to a computer with internet) Exclusion Criteria: * Unable to verbalize comprehension of study or impaired decision-making * Non-English speaking * Limited life expectancy (e.g. hospice or palliative care) * Pregnant or planning to become pregnant * Patients on Kaiser Permanente's "do not call" list for research will also be excluded. **Healthy Volunteers:** True **Maximum Age:** 80 Years **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jordan B King, PharmD, MS **Phone:** 801-213-8797 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Catherine G Derington, PharmD, MS **Phone:** 303-550-1980 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** University of Utah **Name:** Jordan B King, PharmD, MS **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006949 - Term: Hyperlipidemias - ID: D000050171 - Term: Dyslipidemias - ID: D000052439 - Term: Lipid Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M9988 - Name: Hypercholesterolemia - Relevance: HIGH - As Found: Hypercholesterolemia - ID: M10002 - Name: Hyperlipoproteinemias - Relevance: LOW - As Found: Unknown - ID: M10000 - Name: Hyperlipidemias - Relevance: LOW - As Found: Unknown - ID: M26181 - Name: Dyslipidemias - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M27029 - Name: Lipid Metabolism Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000006937 - Term: Hypercholesterolemia ### Intervention Browse Module - Browse Branches - Abbrev: Lipd - Name: Lipid Regulating Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21155 - Name: Hydroxymethylglutaryl-CoA Reductase Inhibitors - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423352 **Brief Title:** A Study to Evaluate Zilebesiran in Japanese Patients With Mild to Moderate Hypertension **Official Title:** A Phase 1/2, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacodynamics, and Pharmacokinetics of Zilebesiran in Japanese Patients With Mild to Moderate Hypertension #### Organization Study ID Info **ID:** ALN-AGT01-006 #### Organization **Class:** INDUSTRY **Full Name:** Alnylam Pharmaceuticals ### Status Module #### Completion Date **Date:** 2025-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Alnylam Pharmaceuticals #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True ### Description Module **Brief Summary:** The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacodynamics (PD) and pharmacokinetics (PK) of zilebesiran in Japanese patients with mild to moderate hypertension. ### Conditions Module **Conditions:** - Mild to Moderate Hypertension **Keywords:** - High blood pressure - Hypertension - Hypertensive - siRNA - Angiotensinogen - AGT ### 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:** 36 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will be administered a single dose of zilebesiran. **Intervention Names:** - Drug: Zilebesiran **Label:** Zilebesiran **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will be administered a single dose of placebo. **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Zilebesiran **Description:** Zilebesiran administered by subcutaneous (SC) injection **Name:** Zilebesiran **Other Names:** - ALN-AGT01 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Placebo administered by SC injection **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Frequency of Adverse Events (AEs) **Time Frame:** Up to 12 months #### Secondary Outcomes **Measure:** Percent Change from Baseline in Serum Angiotensinogen (AGT) at Month 3 and Month 6 **Time Frame:** Baseline and Month 3 and Month 6 **Measure:** Change from Baseline at Month 3 and Month 6 in 24-hour Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Assessed by Ambulatory Blood Pressure Monitoring (ABPM) **Time Frame:** Baseline and Month 3 and Month 6 **Measure:** Change from Baseline at Month 3 and Month 6 in SBP and DBP Assessed by Office Blood Pressure **Time Frame:** Baseline and Month 3 and Month 6 **Measure:** Pharmacokinetics of Zilebesiran and its Metabolite assessed by Plasma Concentration **Time Frame:** Predose and up to 3 days postdose ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Must have been born in Japan, and their biological parents and grandparents must have been of Japanese origin * Has mean systolic office blood pressure (SBP) of \>130 and \<=165 mmHg by automated office blood pressure measurement, after a minimum of 3 weeks of washout if taking hypertensive medication * Has 24-hour mean SBP ≥130 mmHg by ambulatory blood pressure monitoring (ABPM), without antihypertensive medication Exclusion Criteria: * Has secondary hypertension, symptomatic orthostatic hypotension * Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2× upper limit of normal (ULN) * Has elevated serum potassium \>5 mmol/L * Has estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73m\^2 * Has received an investigational agent within the last 30 days * Has Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus or newly diagnosed Type 2 diabetes mellitus * Has history of intolerance to SC injection(s) **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Alnylam Clinical Trial Information Line **Phone:** 1-877-ALNYLAM **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Alnylam Clinical Trial Information Line **Phone:** 1-877-256-9526 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Alnylam Pharmaceuticals **Name:** Medical Director **Role:** STUDY_DIRECTOR ### 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: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006973 - Term: Hypertension ### Intervention Browse Module - Browse Branches - Abbrev: VaCoAg - Name: Vasoconstrictor Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4132 - Name: Angiotensin II - Relevance: LOW - As Found: Unknown - ID: M4135 - Name: Angiotensinogen - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423339 **Brief Title:** Comparison Between Genicular Nerve Block Combined With (IPACK) Block Versus Adductor Canal Block **Official Title:** A Comparative Study Between Ultrasound Guided Genicular Nerve Block Combined With Interspace Between the Popliteal Artery and the Capsule of the Posterior Knee Block Versus Adductor Canal Block in Total Knee Replacement #### Organization Study ID Info **ID:** FAMSU R80/2024 #### Organization **Class:** OTHER **Full Name:** Ain Shams University ### Status Module #### Completion Date **Date:** 2024-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-10 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-04-27 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ain Shams University #### Responsible Party **Investigator Affiliation:** Ain Shams University **Investigator Full Name:** riham fathy galal **Investigator Title:** Lecturer **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The patients will be randomized into 2 groups, named group A, B. Group A: The patients will receive Ultrasound guided Genicular nerves block combined with Ultrasound guided IPACK block. Group B: The patients will receive Adductor canal block which will be the control group. The Numerical Rating Scale (NRS) will be used to assess pain intensity. Preoperatively, all study subjects will be trained to use NRS pain scores. The spinal block will be performed. In group A, 15 mL of bupivacaine 0.25% with 2.5 g/mL adrenaline at a concentration 1:4,00,000 will be administered immediately following skin closure. GNB will be performed by using the linear ultrasound probe (10-15 MHz) Sono site M-turbo ultrasonography to scan the long bone shaft with up and down movement to recognize the epicondyle of the tibia and femur. The junctions between the epicondyle and the shafts of the femur and tibia are where the genicular arteries are located; these junctions will be defined as the periosteal areas. The superior lateral, superior medial and inferior medial genicular arteries accompany each genicular nerve. After confirmation of the genicular artery by color Doppler, the needle will be introduced using the in-plane approach and presented in the long axis view. The target point of the needle insertion will be the needle tip beside a genicular artery. Then, a 5 mL volume will be administered after gentle aspiration to prevent a faulty intra-arterial injection at 3 target locations: the superior lateral, superior medial and inferior medial genicular nerves. This will be Followed by the procedure for the IPACK block. In group B, A 22 Gauge 80 mm needle will be guided from lateral to medial to this area called the adductor canal using in-plane technique. 20 mL of 0.5% bupivacaine will be injected with peri-arterial spread after negative aspiration under sterile conditions. TKA will be performed by an orthopedic surgeon by placing three-compartment prostheses with a minimally invasive mini-midvastus approach and using hand-mixed cementing techniques. **Detailed Description:** The patients will be randomized into 2 equal groups by a computer-generated random numbers table, named group A, B. An independent data manager of computer generated software will be responsible for randomization, assigning the patients to the groups using sequentially numbered, sealed, opaque envelopes containing computer generated random numbers, accessible only to the anesthesiologist performing the block. The subjects will be randomly allocated to one of the two groups. Group A: The patients will receive Ultrasound guided Genicular nerves block combined with Ultrasound guided IPACK block. Group B: The patients will receive Adductor canal block which will be the control group. History taking, clinical examination and routine laboratory investigation will be performed preoperatively, and the patients will be instructed to fast for 8 hours preoperative for solids and 2 hours for clear fluids. On arrival to the operation room, intravenous access will be established and acetated ringer will be infused by rate 10ml/kg. ECG, noninvasive blood pressure and arterial oxygen saturation will be monitored routinely. The Numerical Rating Scale (NRS) will be used to assess pain intensity. Preoperatively, all study subjects will be trained to use NRS pain scores. In the operating room, a peripheral 20 G intravenous (IV) cannula will be inserted. The baseline parameters of five lead electrocardiogram (ECG), non invasive blood pressure and peripheral oxygen saturation will be recorded. IV midazolam 0.02 mg/kg will be administered. The spinal block will be performed using either a 25 or 27 G spinal needle in the sitting position at the L3-L4 or L4-L5 intervertebral space with a 2.5-3 mL hyperbaric bupivacaine 0.5%. The sensory block (to cold and pinprick) to the 10th thoracic dermatome or above will be the target of the spinal block to start the surgery. Hypotension will be defined as ≥20% decrease in blood pressure from baseline measurements and managed by IV Ephedrine6 mg boluses. In group A, 15 mL of bupivacaine 0.25% with 2.5 g/mL adrenaline at a concentration 1:4,00,000 will be administered immediately following skin closure. GNB will be performed by using the linear ultrasound probe (10-15 MHz) Sono site M-turbo ultrasonography to scan the long bone shaft with up and down movement to recognize the epicondyle of the tibia and femur. The junctions between the epicondyle and the shafts of the femur and tibia are where the genicular arteries are located; these junctions will be defined as the periosteal areas. The superior lateral, superior medial and inferior medial genicular arteries accompany each genicular nerve. After confirmation of the genicular artery by color Doppler, the needle will be introduced using the in plane approach and presented in the long axis view. The target point of the needle insertion will be the needle tip beside a genicular artery. Then, a 5 mL volume will be administered after gentle aspiration to prevent a faulty intra arterial injection at 3 target locations: the superior lateral, superior medial and inferior medial genicular nerves. This will be Followed by the procedure for the IPACK block initiated by the visualization of the popliteal artery and posterior surface of the distal femur. Then, the image of the femoral condyles and the popliteal artery will be obtained. A 20G 22G 80 mm needle will be inserted in a medial to the lateral plane, parallel to the femur in the middle area between the popliteal artery and the femur. 20 mL of the local anesthetic solution will be given into this space in increments, ensuring the adequate and equal distribution of the anesthetic agent. In group B, after placing the patients in the supine position, the linear probe of ultrasound (13-6 MHz) will be moved from cephalad to caudal and the superficial femoral artery will be visualized in the short axis, medial to the vastus medialis, lateral to the sartorius muscle, and anterior to the adductor magnus muscle. A 22 Gauge 80 mm needle will be guided from lateral to medial to this area called the adductor canal using in-plane technique. 20 mL of 0.5% bupivacaine will be injected to with peri-arterial spread after negative aspiration under sterile conditions. TKA will be performed by an orthopedic surgeon by placing three-compartment prostheses with a minimally invasive mini-midvastus approach and using hand-mixed cementing techniques. The outcome: The primary outcome will be the total postoperative morphine consumption during the first two postoperative days. NRS will be assessed at 0, 6, 12, 24 and 48 h postoperatively. The period between the end of surgery and the first request for rescue analgesia (NRS \>3) will be considered the time to the first request. Postoperative analgesia, IV paracetamol (1 g/6 h) and IV ketorolac (30 mg/12 h), will be administered to all patients. The pain will be assessed at rest and during movement using NRS (metric score 0-10 for pain severity assessment: mild pain = 1-3, moderate = 4-7 and severe = 8 and above) on the first and second days. When NRS will be \>3, rescue analgesia (morphine 3 mg IV) will be given and repeated whenever required. The secondary outcome will be assessment of Postoperative functional outcomes and knee rehabilitation parameters including quadriceps motor strength score measured by straight leg raising (SLR), knee range of motion (ROM) and time up and go (TUG) test. SLR will be assessed on a scale ranging from 0 to 5 as follows: 0 = unable to contract muscles, 1 = muscles twitch, the limb does not move, 2 = able to move the limb with gravity elimination and passive assistance, 3 = able to move the limb against gravity without resistance (no cuff weights weight wrapped around your thigh just above your kneecap), 4 = move the limb against some resistance (cuff weights weight wrapped around your thigh just above your kneecap) and 5 = normal motor strength against resistance. TUG is a performance test to measure functional mobility. The test requirements will be presented as the subject rises from a chair, walks 3.0 m easily to reach a mark placed on the floor, turns around at the 3.0 m mark, returns to the starting point and sits on the chair. The time the subject takes to complete the test is defined as the TUG score. Patients' movement with aid within 24 h will be encouraged when the motor strength was at least two. The postoperative patient satisfaction and incidence of adverse effects will be recorded. Patient satisfaction will be measured by a self administered satisfaction scale (very satisfied, somewhat satisfied, somewhat dissatisfied, very dissatisfied). ### Conditions Module **Conditions:** - Post Operative Pain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Group A will receive genicular nerve block combined with interspace between the popliteal artery and the capsule of the posterior knee block(IPACK) **Intervention Names:** - Procedure: Ultrasound guided Genicular nerve block - Procedure: Interspace between the popliteal artery and the capsule of the popliteal artery and the capsule of the posterior knee - Drug: Bupivacaine Hydrochloride **Label:** Group A **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Group B will receive ultrasound guided sub-sartorial Adductor canal block (ACB) **Intervention Names:** - Procedure: Adductor canal block - Drug: Bupivacaine Hydrochloride **Label:** Group B **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Group A **Description:** Ultrasound guided genicular nerve block **Name:** Ultrasound guided Genicular nerve block **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Group A **Description:** Ultrasound guided Interspace between the popliteal artery and the capsule of the popliteal artery and the capsule of the posterior knee **Name:** Interspace between the popliteal artery and the capsule of the popliteal artery and the capsule of the posterior knee **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Group B **Description:** Ultrasound guided sub-sartorial Adductor canal block **Name:** Adductor canal block **Type:** PROCEDURE #### Intervention 4 **Arm Group Labels:** - Group A - Group B **Description:** Pupivacaine 0.5% in 20 ml vial **Name:** Bupivacaine Hydrochloride **Other Names:** - Sunnypivacaine **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The primary outcome will be the total postoperative morphine consumption during the first two postoperative days. **Measure:** The primary outcome will be the total postoperative morphine consumption during the first two postoperative days. **Time Frame:** 48 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients American Society of anesthesiologists' physical status (ASA) I to III. 2. Aged 40 to 70 years. 3. Both sexes. 4. Patients scheduled for unilateral total knee replacement. Exclusion Criteria: 1. Patients with spinal malformation 2. Patients with liver impairment 3. Patients with renal impairment 4. Patients younger than 40 years or older than 70 years 5. Patients with hypersensitivity to one of the used drugs 6. Patients with neuromuscular disorders and 7. Coagulopathy disorders 8. Patients scheduled for revision knee arthroplasty or those who had a past history of previous surgery or trauma to the knee **Maximum Age:** 70 Years **Minimum Age:** 40 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Riham F. Galal, MD **Phone:** 01022739211 **Phone Ext:** +2 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Ahmad M Ehab, MD **Phone:** 01111897888 **Phone Ext:** +2 **Role:** CONTACT #### Locations **Location 1:** **City:** Cairo **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Riham F. Galal, MD - **Phone:** 01022739211 - **Phone Ext:** +2 - **Role:** CONTACT **Country:** Egypt **Facility:** Ain shams university hospitals **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M13069 - Name: Pain, Postoperative - Relevance: HIGH - As Found: Post Operative Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010149 - Term: Pain, Postoperative ### Intervention Browse Module - Ancestors - ID: D000000779 - Term: Anesthetics, Local - ID: D000000777 - Term: Anesthetics - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M5315 - Name: Bupivacaine - Relevance: HIGH - As Found: IFN - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000002045 - Term: Bupivacaine ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423326 **Brief Title:** Gemcitabine, Cisplatin and Nab-Paclitaxel as Neoadjuvant Treatment for Patients With Resectable or Borderline Resectable Pancreatic Cancer **Official Title:** A Single-Arm Phase II Clinical Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel as Neoadjuvant Therapy for Pancreatic Ductal Adenocarcinoma #### Organization Study ID Info **ID:** STUDY00006976 #### Organization **Class:** OTHER **Full Name:** Emory University #### Secondary ID Infos **Domain:** CTRP (Clinical Trial Reporting Program) **ID:** NCI-2024-02082 **Type:** REGISTRY **Domain:** Emory University Hospital/Winship Cancer Institute **ID:** WINSHIP6093-23 **Type:** OTHER **ID:** P30CA138292 **Link:** https://reporter.nih.gov/quickSearch/P30CA138292 **Type:** NIH **Domain:** Emory University Hospital/Winship Cancer Institute **ID:** STUDY00006976 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-04-10 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Cancer Institute (NCI) #### Lead Sponsor **Class:** OTHER **Name:** Emory University #### Responsible Party **Investigator Affiliation:** Emory University **Investigator Full Name:** Mihir M. Shah, MD, FACS, FSSO **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False ### Description Module **Brief Summary:** This phase II trial tests how well gemcitabine, cisplatin and nab-paclitaxel given before surgery (neoadjuvant) works in treating patients with pancreatic cancer that can be removed by surgery (resectable) or that is borderline resectable. The standard treatment for resectable and borderline resectable pancreatic cancer is a combination of surgery and chemotherapy. Neoadjuvant therapy has been shown to improve overall survival compared to patients receiving surgery first. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel, an antimicrotubule agent that stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel may have fewer side effects and work better than other forms of paclitaxel. Gemcitabine, cisplatin and nab-paclitaxel may be an effective neoadjuvant treatment option for patients with resectable or borderline resectable pancreatic cancer. **Detailed Description:** PRIMARY OBJECTIVE: I. Determine the major pathological response rate, feasibility and safety of biweekly gemcitabine, cisplatin and nab-paclitaxel (GCN) in the neoadjuvant setting for patients with resectable and borderline resectable pancreatic ductal adenocarcinoma. SECONDARY OBJECTIVE: I. Determine if neoadjuvant GCN increases tumoral infiltration of lymphocytes with local and systemic phenotypic features that assist in the antitumor immune response. OUTLINE: Patients receive nab-paclitaxel intravenously (IV) over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine IV over 30 minutes on days 1 and 15 of each cycle. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease, partial or complete response undergo surgical resection per standard of care. Additionally, patients undergo biopsy on study and undergo blood sample collection and computed tomography (CT) or magnetic resonance imaging (MRI) at pre-study and on study. After completion of study treatment, patients are followed up every 3-4 months for up to 24 months. ### Conditions Module **Conditions:** - Borderline Resectable Pancreatic Ductal Adenocarcinoma - Resectable Pancreatic Adenocarcinoma - Stage I Pancreatic Cancer AJCC v8 - Stage II Pancreatic Cancer AJCC v8 - Stage III Pancreatic Cancer AJCC v8 ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 44 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients receive nab-paclitaxel IV over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine IV over 30 minutes on days 1 and 15 of each cycle. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease, partial or complete response undergo surgical resection per standard of care. Additionally, patients undergo biopsy on study and undergo blood sample collection and CT or MRI at pre-study and on study. **Intervention Names:** - Procedure: Biopsy - Procedure: Biospecimen Collection - Drug: Cisplatin - Procedure: Computed Tomography - Drug: Gemcitabine - Procedure: Magnetic Resonance Imaging - Drug: Nab-paclitaxel - Procedure: Pancreatic Surgical Procedure **Label:** Treatment (nab-paclitaxel, cisplatin, gemcitabine) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment (nab-paclitaxel, cisplatin, gemcitabine) **Description:** Undergo biopsy **Name:** Biopsy **Other Names:** - BIOPSY_TYPE - Bx **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Treatment (nab-paclitaxel, cisplatin, gemcitabine) **Description:** Undergo blood sample collection **Name:** Biospecimen Collection **Other Names:** - Biological Sample Collection - Biospecimen Collected - Specimen Collection **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Treatment (nab-paclitaxel, cisplatin, gemcitabine) **Description:** Given IV **Name:** Cisplatin **Other Names:** - Abiplatin - Blastolem - Briplatin - CDDP - Cis-diammine-dichloroplatinum - Cis-diamminedichloridoplatinum - Cis-diamminedichloro Platinum (II) - Cis-diamminedichloroplatinum - Cis-dichloroammine Platinum (II) - Cis-platinous Diamine Dichloride - Cis-platinum - Cis-platinum II - Cis-platinum II Diamine Dichloride - Cismaplat - Cisplatina - Cisplatinum - Cisplatyl - Citoplatino - Citosin - Cysplatyna - DDP - Lederplatin - Metaplatin - Neoplatin - Peyrone's Chloride - Peyrone's Salt - Placis - Plastistil - Platamine - Platiblastin - Platiblastin-S - Platinex - Platinol - Platinol- AQ - Platinol-AQ - Platinol-AQ VHA Plus - Platinoxan - Platinum - Platinum Diamminodichloride - Platiran - Platistin - Platosin **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Treatment (nab-paclitaxel, cisplatin, gemcitabine) **Description:** Undergo CT **Name:** Computed Tomography **Other Names:** - CAT - CAT Scan - Computed Axial Tomography - Computerized Axial Tomography - Computerized axial tomography (procedure) - Computerized Tomography - Computerized Tomography (CT) scan - CT - CT Scan - tomography **Type:** PROCEDURE #### Intervention 5 **Arm Group Labels:** - Treatment (nab-paclitaxel, cisplatin, gemcitabine) **Description:** Given IV **Name:** Gemcitabine **Other Names:** - dFdC - dFdCyd - Difluorodeoxycytidine **Type:** DRUG #### Intervention 6 **Arm Group Labels:** - Treatment (nab-paclitaxel, cisplatin, gemcitabine) **Description:** Undergo MRI **Name:** Magnetic Resonance Imaging **Other Names:** - Magnetic Resonance - Magnetic Resonance Imaging (MRI) - Magnetic resonance imaging (procedure) - Magnetic Resonance Imaging Scan - Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance - MR - MR Imaging - MRI - MRI Scan - MRIs - NMR Imaging - NMRI - Nuclear Magnetic Resonance Imaging - sMRI - Structural MRI **Type:** PROCEDURE #### Intervention 7 **Arm Group Labels:** - Treatment (nab-paclitaxel, cisplatin, gemcitabine) **Description:** Given IV **Name:** Nab-paclitaxel **Other Names:** - ABI 007 - ABI-007 - Abraxane - Albumin-bound Paclitaxel - Albumin-Stabilized Nanoparticle Paclitaxel - Nanoparticle Albumin-bound Paclitaxel - Nanoparticle Paclitaxel - Paclitaxel Albumin - paclitaxel albumin-stabilized nanoparticle formulation - Paclitaxel Nanoparticle Albumin-bound - Paclitaxel Protein-Bound - Protein-bound Paclitaxel **Type:** DRUG #### Intervention 8 **Arm Group Labels:** - Treatment (nab-paclitaxel, cisplatin, gemcitabine) **Description:** Undergo surgical resection **Name:** Pancreatic Surgical Procedure **Other Names:** - Pancreatic Surgery **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Pathologic response rate will be defined by College of American Pathologists scoring system as 0 (complete response), 1 (near complete response), 2 (partial response) and 3 (poor or no response). Pathologic response rate will be reported as a proportion of 0 and 1, with and exact 90% confidence interval estimated using the Clopper-Pearson method. **Measure:** Pathologic response rate **Time Frame:** At time of surgery #### Secondary Outcomes **Description:** Feasibility will be defined as completion of all preoperative and operative therapy. Treatment completion will reported as a proportion, with an exact 95% confidence interval estimated using the Clopper-Pearson method. **Measure:** Treatment completion **Time Frame:** Up to 24 months **Description:** AEs, with severity will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Descriptive statistics will be reported, using frequencies and percentages for each toxicity. **Measure:** Incidence of adverse events (AEs) **Time Frame:** Up to 28 days after last dose of study treatment **Description:** Radiological response rate will be defined as complete response, partial response or stable disease after study treatment evaluated using Response Evaluation Criteria in Solid Tumors version 1.1. Radiologic response rate will be reported as a proportion, with an exact 95% confidence interval estimated using the Clopper-Pearson method. **Measure:** Radiologic response rate **Time Frame:** Up to 24 months **Description:** R0 resection indicates a microscopically margin-negative resection. R0 resection rate will reported as a proportion, with an exact 95% confidence interval estimated using the Clopper-Pearson method. **Measure:** R0 resection rate **Time Frame:** At time of surgery **Description:** N0, N1, and N2 will be reported using frequencies and percentages. **Measure:** Nodal status **Time Frame:** Up to 24 months **Description:** RFS will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median RFS will be estimated using the Brookmeyer-Crowley approach. **Measure:** Recurrence-free survival (RFS) **Time Frame:** From surgery to recurrence or death, assessed up to 24 months **Description:** OS will be estimated using the Kaplan-Meier method, and median survival will be calculated. A 95% confidence interval will be estimated using the Brookmeyer-Crowley approach. **Measure:** Overall survival (OS) rate **Time Frame:** From study treatment start to date of death, assessed up to 24 months **Description:** CA19-9 response will be defined as \> 50% decrease from baseline will be correlated with tumor response. CA19-9 will be reported as a proportion, with an exact 95% confidence interval estimated using the Clopper-Pearson method. CA19-9 will be correlated with RFS and OS using log-rank tests and Cox proportional hazards regression. Model assumptions will be checked and verified. **Measure:** Carbohydrate antigen (CA)19-9 response **Time Frame:** Up to 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Histologically or cytologically confirmed - resectable and borderline resectable pancreatic ductal adenocarcinoma * Resectability will be defined as per National Comprehensive Cancer Network (NCCN) guidelines using cross-sectional imaging (contrast-enhanced computed tomography or magnetic resonance imaging scans of the abdomen, and pelvis) * Decisions about resectability status will be made in consensus at multidisciplinary meetings/discussions Resectable disease will be defined as: * No interface of the tumor with celiac artery, common hepatic artery (CHA), or superior mesenteric arteries (SMA) (and, if present, variants) * Less than 180° interface between tumor and vessel wall of the portal or superior mesenteric veins (SMV) without vein contour irregularity * For tumors of the body and tail of the pancreas, interface with the splenic artery and splenic vein of any degree will be considered resectable disease Borderline resectable disease will be defined as: * To include at least one of the following: * Tumor abutment \< 180° of the superior mesenteric artery or celiac axis * Solid tumor contact with CHA without extension to celiac artery (CA) or hepatic artery bifurcation allowing for safe and complete resection and reconstruction * Solid tumor contact with variant arterial anatomy (ex: accessory right hepatic artery, replaced right hepatic artery, replaced CHA, and the origin of replaced or accessory artery) * Tumor induced narrowing of SMV, portal vein (PV) or SMV-PV of \> 180˚ of the diameter of the vessel * Short segment occlusion of the SMV, PV or SMV-PV with a suitable PV above and SMV below, for reconstruction * Solid tumor contact with inferior vena cava * Biopsy proven N1 disease (regional lymph nodes involved) from pre-referral biopsy or endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA) * No distant extrapancreatic disease (M0) * Adults \> 18 years of age * Able to give informed consent * Able to adhere to study visit schedule and other protocol requirements * Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1 * Absolute neutrophil count (ANC) ≥ 1,500 cells/ul * Platelet count ≥ 100,000 cells/ul * Hemoglobin ≥ 9 g/dL * Serum total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN * Albumin ≥ 3 g/dl * Creatinine ≤ 1.5 x ULN * Male, or a non-pregnant and non-lactating female * Women of child-bearing potential - defined as a sexually mature woman who has not undergone hysterectomy - the surgical removal of the uterus or bilateral oophorectomy - the surgical removal of both ovaries or has not been naturally postmenopausal for at least 24 consecutive months, i.e., has had menses at any time during the preceding 24 consecutive months, must commit to true abstinence from heterosexual contact, or agree to use, and be able to comply with, effective contraception without interruption for 28 days prior to starting gemcitabine/cisplatin/nab- paclitaxel (including dose interruptions) until treatment with gemcitabine/cisplatin/nab-paclitaxel is complete * Male subjects must practice true abstinence or agree to use a condom during sexual contact with a female of childbearing potential or a pregnant female while on treatment (including during dose interruptions) with gemcitabine/cisplatin/nab-paclitaxel and for 6 months following gemcitabine/cisplatin/nab- paclitaxel discontinuation, even if he has undergone a successful vasectomy Exclusion Criteria: * Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 4.0. In CTCAE version 4.0 grade 2 sensory neuropathy is defined as "moderate symptoms; limiting instrumental activities of daily living (ADLs)" * Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study such as unstable angina, myocardial infarction within 6 months, unstable symptomatic arrhythmia, symptomatic congestive heart failure, uncontrolled diabetes, serious active, uncontrolled infection after inadequate biliary drainage if tumor obstructing bile duct, or psychiatric illness/social situations * Pregnancy (positive pregnancy test) or lactation * Known central nervous system (CNS) disease, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (radiosurgery \[RS\]; Gamma Knife, linear accelerator \[LINAC\], or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to day 1 will be excluded * Previous (within the past 5 years) or concurrent presence of other untreated cancer, except nonmelanoma skin cancer and in situ carcinomas * History of allergy or hypersensitivity to any of the study drugs * Current abuse of alcohol or illicit drugs * Inability or unwillingness to sign the informed consent form **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Mihir M. Shah, MD **Phone:** 404-778-3307 **Role:** CONTACT #### Locations **Location 1:** **City:** Atlanta **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Kathleen M. Coleman - **Role:** CONTACT ***Contact 2:*** - **Name:** Mihir M. Shah, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Emory University Hospital/Winship Cancer Institute **State:** Georgia **Zip:** 30322 #### Overall Officials **Official 1:** **Affiliation:** Emory University Hospital/Winship Cancer Institute **Name:** Mihir M Shah, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000010182 - Term: Pancreatic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - 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: M3585 - Name: Adenocarcinoma - Relevance: HIGH - As Found: Adenocarcinoma - ID: M13110 - Name: Pancreatic Neoplasms - Relevance: HIGH - As Found: Pancreatic Cancer - 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: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M13102 - Name: Pancreatic Diseases - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: T4387 - Name: Pancreatic Cancer - Relevance: HIGH - As Found: Pancreatic Cancer ### Condition Browse Module - Meshes - ID: D000000230 - Term: Adenocarcinoma - ID: D000010190 - Term: Pancreatic Neoplasms ### Intervention Browse Module - Ancestors - ID: D000000972 - Term: Antineoplastic Agents, Phytogenic - ID: D000000970 - Term: Antineoplastic Agents - ID: D000050257 - Term: Tubulin Modulators - ID: D000050256 - Term: Antimitotic Agents - ID: D000050258 - Term: Mitosis Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000000963 - Term: Antimetabolites ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M19537 - Name: Paclitaxel - Relevance: HIGH - As Found: Surgery - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: HIGH - As Found: CD19 - ID: M6182 - Name: Cisplatin - Relevance: HIGH - As Found: Locally Advanced - ID: M2985 - Name: Gemcitabine - Relevance: HIGH - As Found: Activity - ID: M26197 - Name: Tubulin Modulators - Relevance: LOW - As Found: Unknown - ID: M26196 - Name: Antimitotic Agents - Relevance: LOW - As Found: Unknown - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000017239 - Term: Paclitaxel - ID: D000068196 - Term: Albumin-Bound Paclitaxel - ID: D000002945 - Term: Cisplatin - ID: D000093542 - Term: Gemcitabine ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423313 **Brief Title:** Effects of Anesthesia Type on QoR-40 **Official Title:** The Comparison of Total Intravenous Anesthesia and Inhalation Anesthesia Effects on Postoperative Recovery by Quality of Recovery (QoR-40) in Septorhinoplasty #### Organization Study ID Info **ID:** 2024/07-1 #### Organization **Class:** OTHER **Full Name:** Zonguldak Bulent Ecevit University ### Status Module #### Completion Date **Date:** 2024-10-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-08-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Zonguldak Bulent Ecevit University #### Responsible Party **Investigator Affiliation:** Zonguldak Bulent Ecevit University **Investigator Full Name:** Çağdaş Baytar **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** To compare the effects of total intravenous anesthesia and inhalation anesthesia used for maintenance on postoperative recovery in patients undergoing septorhinoplasty surgery under general anesthesia, using the recovery quality score (QoR-40). ### Conditions Module **Conditions:** - General Anesthesia - İnhalation Anesthetics - Quality of Recovery **Keywords:** - total intravenous anesthesia - anesthesia maintenance - inhalation anesthesia - quality of recovery-40 ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 1 **Type:** ACTUAL **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Day ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Procedure: maintenance of anesthesia **Label:** Group TIVA #### Arm Group 2 **Intervention Names:** - Procedure: maintenance of anesthesia **Label:** Group Inhalation ### Interventions #### Intervention 1 **Arm Group Labels:** - Group Inhalation - Group TIVA **Description:** Types used to maintain anesthesia **Name:** maintenance of anesthesia **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** measurement of recovery quality in the first 24 hours after extubation **Measure:** quality of recovery-40 questionnaire **Time Frame:** up to 24 hour after surgery #### Secondary Outcomes **Description:** complications that may occur in the postoperative period **Measure:** postoperative complications **Time Frame:** up to 24 hour after surgery **Description:** time between the last suture and extubation **Measure:** duration of extubation **Time Frame:** end of the surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18-65 years old * ASA I-II-III risk group * Patients whose consent was obtained with an informed consent form * Patients who will undergo septorhinoplasty surgery Exclusion Criteria: * -ASA \>3 * Psychiatric illness that prevents them from answering the questionnaire * Patients with a history of chronic opioid and benzodiazepine use as it may affect recovery time * Severe renal and hepatic insufficiency * Severe respiratory and cardiovascular disease * Patients with a body mass index \>30 kg m2 * Patients with a known history of allergy or contraindication to any of the drugs to be used in the study **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study will include intubated patients who will undergo septorhinoplasty surgery under general anesthesia, aged 18-65 years, in the American Society of Anesthesiology (ASA) I-II-III risk class. ### Contacts Locations Module #### Locations **Location 1:** **City:** Zonguldak **Country:** Turkey **Facility:** Zonguldak Bülent Ecevit University Medicine Faculty **State:** Kozlu **Zip:** 67600 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012120 - Term: Respiration Disorders - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M27137 - Name: Respiratory Aspiration - Relevance: HIGH - As Found: Inhalation - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000053120 - Term: Respiratory Aspiration ### 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 - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: HIGH - As Found: Function - ID: M4854 - Name: Benzocaine - Relevance: LOW - As Found: Unknown - ID: T433 - Name: Tannic Acid - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000777 - Term: Anesthetics ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423300 **Brief Title:** [Trial of device that is not approved or cleared by the U.S. FDA] **Official Title:** [Trial of device that is not approved or cleared by the U.S. FDA] #### Organization Study ID Info **ID:** CIP0001 #### Organization **Full Name:** [Redacted] ### Status Module **Delayed Posting:** True #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** WITHHELD #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-04-24 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Name:** [Redacted] #### Responsible Party **Old Name Title:** [Redacted] **Old Organization:** [Redacted] ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423287 **Acronym:** TRELO **Brief Title:** Effects of TRE With Lactobacillus Plantarum LP-KFY04 Supplementation on Overweight / Obese Individuals **Official Title:** Effects of Time-Restricted Eating With Lactobacillus Plantarum LP-KFY04 Supplementation on Overweight / Obese Individuals : A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial #### Organization Study ID Info **ID:** 2024LX0016_GY #### Organization **Class:** OTHER **Full Name:** Zhujiang Hospital ### Status Module #### Completion Date **Date:** 2025-01-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-01-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-04-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Zhujiang Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** With the improvement of the quality of life, multi-nutritional dietary intake today has provided people with a solid foundation for their health profiles. Time-restricted eating is found to be an effective method to prevent and control obesity, helping obese patients to lose weight in a way of reshaping the gut microbiota. Regulation of gut microbiota, as a valid weight-loss strategy, can be achieved by oral supplementation of probiotics. This study aims to evaluate the effectiveness of time-restricted eating combined with Lactobacillus Plantarum LP-KFY04 on overweight/obese population through a multi-center, randomized and double-blind clinical trial. **Detailed Description:** With the improvement of the quality of life, multi-nutritional dietary intake today has provided people with a solid foundation for their health profiles. Time-restricted eating is found to be an effective method to prevent and control obesity, helping obese patients to lose weight in a way of reshaping the gut microbiota. Regulation of gut microbiota, as a valid weight-loss strategy, can be achieved by oral supplementation of probiotics. This study aims to evaluate the effectiveness of time-restricted eating combined with Lactobacillus Plantarum LP-KFY04 on overweight/obese population through a multi-center, randomized and double-blind clinical trial.Patients in the treatment group will be instructed to eat in an 8-hour time window (a set period of time decided by the patients) with supplementation of Lactobacillus plantarum LP-KFY04 over 12 weeks'trial.Patients in the control group will be instructed to eat in an 8-hour time window (a set period of time decided by the patients) with supplementation of placebo over 12 weeks' trial. ### Conditions Module **Conditions:** - Obesity **Keywords:** - Obesity - Time-restricted Diet - Probiotic Compound LP-KFY04 - Weight Loss ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 160 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients in the treatment group will be instructed to eat in an 8-hour time window (a set period of time decided by the patients) with supplementation of Lactobacillus plantarum LP-KFY04 over 12 weeks' trial. **Intervention Names:** - Dietary Supplement: Lactobacillus plantarum LP-KFY04 **Label:** Lactobacillus plantarum LP-KFY04 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients in the control group will be instructed to eat in an 8-hour time window (a set period of time decided by the patients) with supplementation of placebo over 12 weeks' trial. **Intervention Names:** - Other: Take placebo in addition to the limited diet. **Label:** placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Lactobacillus plantarum LP-KFY04 **Description:** Patients in the treatment group will be instructed to eat in an 8-hour time window (a set period of time decided by the patients) with supplementation of Lactobacillus plantarum LP-KFY04 over 12 weeks' trial. **Name:** Lactobacillus plantarum LP-KFY04 **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - placebo **Description:** Patients in the control group will be instructed to eat in an 8-hour time window (a set period of time decided by the patients) with supplementation of placebo over 12 weeks'trial. **Name:** Take placebo in addition to the limited diet. **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Change of body weight from baseline to 12 weeks after intervention **Time Frame:** 12 weeks #### Secondary Outcomes **Measure:** Changes of BMI compared with baseline in subjects **Time Frame:** 12 weeks **Measure:** Changes of waist circumference compared with baseline in subjects **Time Frame:** 12 weeks **Measure:** Changes of body fat percentage (BF%) compared with baseline assessed by dual-energy X-ray absorptiometry (DEXA) **Time Frame:** 12 weeks **Measure:** Change of subjects' HOMA-IR compared with baseline **Time Frame:** 12 weeks **Measure:** Changes of blood pressure in subjects compared with baseline **Time Frame:** 12 weeks **Measure:** Changes of blood glucose in subjects compared with baseline **Time Frame:** 12 weeks **Description:** Blood lipids includes total cholesterol、triglyceride、LDL-c、HDL-c. **Measure:** Changes of blood lipids in subjects compared with baseline **Time Frame:** 12 weeks **Description:** Species of intestinal microbial includes Firmicutes、Bacteroidetes、Proteobacteria、Actinobacteriota、Verrucomicrobia、Fusobacteria. **Measure:** Changes of intestinal microbial composition compared with baseline in subjects **Time Frame:** 12 weeks **Description:** Proportion of intestinal microbial such as Firmicutes、Bacteroidetes、Proteobacteria、Actinobacteriota、Verrucomicrobia、Fusobacteria **Measure:** Changes of intestinal microbial abundance compared with baseline in subjects **Time Frame:** 12 weeks **Description:** Plasma metabolite includes arachidonic acid 、betaine、glutathione and so on. **Measure:** Changes of plasma metabolite compared with baseline in subjects **Time Frame:** 12 weeks **Measure:** The incidence of adverse events in two groups of subjects **Time Frame:** 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Men or women aged 18 to 65 years old 2. BMI 24.0 to 40kg/m2 3. Patients who are aware of the purpose of the trail, willing to participate in the trial and sign informed consent forms, and comply with all requirements (including those during follow-up and evaluation investigations) Exclusion Criteria: 1. History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis; 2. Diagnosis of type 1 or type 2 diabetes and prescribing hypoglycemic therapy 3. History of malignant tumors 4. Serious liver dysfunction or chronic kidney disease (aspartate aminotransferase (AST) or alanine transaminase (ALT) \> 3 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m2) 5. History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction, or stroke) within the past 6 months 6. History of serious gastrointestinal disease or gastrointestinal surgery within the past 12 months 7. History of Cushing's syndrome, hypothyroidism, acromegaly, and hypothalamic obesity 8. Smoking or have smoked within the past 3 months of the screening period 9. Drinking alcohol or drinking more than 15 grams of alcohol per day within the past 3 months of the screening period 10. Taking any medicine that may affect weight or metabolism within the past 6 months, including weight loss medications, antipsychotics, or other medications identified by the researchers 11. Currently involving in a weight loss program or having significant weight change within the past 3 months (\> 5% of current weight) 12. Women who are pregnant or planning for pregnant 13. Patients who are unable to complete 12-week follow-up (due to health conditions or immigration reasons) 14. Patients who are unwilling or unable to provide informed consent **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Hong Chen, MD **Phone:** 13602759769 **Role:** CONTACT #### Locations **Location 1:** **City:** Guangzhou **Country:** China **Facility:** Zhujiang Hospital of Southern Medical University **State:** Guangdong **Status:** RECRUITING **Zip:** 510000 #### Overall Officials **Official 1:** **Affiliation:** Zhujiang Hospital **Name:** Hong Chen, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight ### Condition Browse Module - Browse Branches - Abbrev: 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: LOW - As Found: Unknown - ID: M26186 - Name: Overweight - Relevance: HIGH - As Found: Overweight - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M18102 - Name: Weight Loss - Relevance: LOW - As Found: Unknown - ID: M25307 - Name: Overnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000050177 - Term: Overweight ### Intervention Browse Module - Browse Branches - Abbrev: Ot - Name: Other Dietary Supplements - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T355 - Name: Acidophilus - Relevance: HIGH - As Found: Next ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423274 **Brief Title:** Comparing Artificial Intelligence for Assisted Diagnosis of Diabetic Retinopathy **Official Title:** A Comparative Analysis of the Diagnostic Outcomes of Artificial Intelligence-assisted Fundus Photography for Diabetic Retinopathy and Diabetic Macular Edema Versus Other Imaging Devices in Ophthalmology: A Controlled Trial #### Organization Study ID Info **ID:** DR artificial intelligence #### Organization **Class:** OTHER **Full Name:** Zhejiang University ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-10 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Zhejiang University #### Responsible Party **Investigator Affiliation:** Second Affiliated Hospital, School of Medicine, Zhejiang University **Investigator Full Name:** Wu Hongkang **Investigator Title:** Director **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 plans to compare the accuracy of artificial intelligence (AI)-assisted fundus images with other ophthalmic devices such as optical coherence tomography (OCT) and fundus fluorescence angiography (FFA) in the diagnosis of diabetic retinopathy and diabetic macular edema. **Detailed Description:** This study plans to compare the accuracy of artificial intelligence (AI)-assisted fundus images with other ophthalmic devices such as optical coherence tomography (OCT) and fundus fluorescence angiography (FFA) in the diagnosis of diabetic retinopathy and diabetic macular edema. This study was conducted as a prospective study. Participants meeting eligibility criteria will be recruited from sites staffed by trained photographers. After assessing eligibility and obtaining informed consent, fundus photographs will be taken using a non-dilated fundus camera. And optical coherence tomography or fundus fluorescence angiography will be performed. ### Conditions Module **Conditions:** - Diabetic Retinopathy - Diabetic Macular Edema **Keywords:** - diabetic retinopathy - diabetic macular edema - artificial intelligence ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 1000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Artificial intelligence-assisted fundus photography in patients with diabetic retinopathy **Intervention Names:** - Diagnostic Test: fundus photography **Label:** artificial intelligence-assisted fundus photography #### Arm Group 2 **Description:** optical coherence tomography in patients with diabetic retinopathy **Intervention Names:** - Diagnostic Test: optical coherence tomography **Label:** optical coherence tomography #### Arm Group 3 **Description:** fundus fluorescence angiography in patients with diabetic retinopathy **Intervention Names:** - Diagnostic Test: fundus fluorescence angiography **Label:** fundus fluorescence angiography ### Interventions #### Intervention 1 **Arm Group Labels:** - artificial intelligence-assisted fundus photography **Description:** using artificial intelligence to identify diabetic retinopathy using fundus photography **Name:** fundus photography **Type:** DIAGNOSTIC_TEST #### Intervention 2 **Arm Group Labels:** - optical coherence tomography **Description:** detect diabetic retinopathy and diabetic macular edema by optical coherence tomography **Name:** optical coherence tomography **Type:** DIAGNOSTIC_TEST #### Intervention 3 **Arm Group Labels:** - fundus fluorescence angiography **Description:** detect diabetic retinopathy by fundus fluorescence angiography **Name:** fundus fluorescence angiography **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Detection of DR accuracy using fundus photography, optical coherence tomography, and fundus fluorescence angiography **Measure:** The accuracy **Time Frame:** Baseline-Month 12 #### Secondary Outcomes **Description:** Detection of DME accuracy using fundus photography, optical coherence tomography, and fundus fluorescence angiography **Measure:** The accuracy **Time Frame:** Baseline-Month 12 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Diagnostic for diabetes: Type 1 diabetes of a lest 5 years of evolution; or Type 2 diabetes; 2. Obtaining informed consent; 3. Patient age 18 or above. Exclusion Criteria: 1. Patients under 18 years of age; 2. Failure to Obtain informed consent; 3. Presence of other retinal diseases; 4. A patient who has already undergone the treatment. **Healthy Volunteers:** True **Maximum Age:** 90 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** It is planned to include 1,000 participants in the study, all of whom will undergo fundus photography, 500 additional patients will undergo fundus fluorescence angiography, and 500 additional patients will undergo optical coherence tomography. All participants met inclusion and exclusion criteria. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Hongkang Wu, MMS **Phone:** +8618969978676 **Role:** CONTACT #### Locations **Location 1:** **City:** Hangzhou **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Hongkang Wu, MMS - **Phone:** 18969978676 - **Role:** CONTACT **Country:** China **Facility:** The Second Affiliated Hospital Zhejiang University School of Medicine **State:** Zhejiang **Zip:** 310000 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003920 - Term: Diabetes Mellitus - ID: D000004700 - Term: Endocrine System Diseases - ID: D000008268 - Term: Macular Degeneration - ID: D000012162 - Term: Retinal Degeneration - ID: D000005128 - Term: Eye Diseases - ID: D000003925 - Term: Diabetic Angiopathies - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000048909 - Term: Diabetes Complications ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M11261 - Name: Macular Edema - Relevance: HIGH - As Found: Macular Edema - ID: M7657 - Name: Edema - Relevance: HIGH - As Found: Edema - ID: M7125 - Name: Diabetic Retinopathy - Relevance: HIGH - As Found: Diabetic Retinopathy - ID: M14999 - Name: Retinal Diseases - Relevance: HIGH - As Found: Retinopathy - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M11260 - Name: Macular Degeneration - Relevance: LOW - As Found: Unknown - ID: M14997 - Name: Retinal Degeneration - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: M7120 - Name: Diabetic Angiopathies - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M26004 - Name: Diabetes Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008269 - Term: Macular Edema - ID: D000012164 - Term: Retinal Diseases - ID: D000003930 - Term: Diabetic Retinopathy - ID: D000004487 - Term: Edema ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423261 **Brief Title:** Safety, Tolerability, Pharmacokinetics and Immunogenicity Study of GB002 Recombinant Peptide Inhalation Solution in Healthy Subjects **Official Title:** Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of GB002 Recombinant Polypeptide Inhalation Solution in a Randomized, Double-blind, Placebo-controlled, Dose-increasing Single and Multiple Administration in Chinese Healthy Adult Subjects. #### Organization Study ID Info **ID:** YKSW-GB002-R01 #### Organization **Class:** INDUSTRY **Full Name:** Zhejiang Echon Biopharm Limited ### Status Module #### Completion Date **Date:** 2024-07-29 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2023-08-24 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-04-30 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Zhejiang Echon Biopharm Limited #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This trial is conducted in China. The purpose of this clinical trial is to evaluate the safety and tolerability, pharmacokinetic (PK) characteristics, and immunogenicity of single/multiple inhalation of different doses of GB002 recombinant peptide in healthy subjects. ### Conditions Module **Conditions:** - Healthy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Each subject will receive one single administration of GB002 recombinant peptide inhalation solution. The dosage of each group is 0.625mg, 1.25mg, 2.5mg, 5.0mg,7.5mg, respectively. **Intervention Names:** - Drug: GB002 Recombinant Peptide Inhalation Solution - Drug: Placebo **Label:** Single Ascending Dose of GB002 Recombinant Peptide Inhalation Solution **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The subjects will receive multiple doses of GB002 recombinant peptide inhalation solution, administered twice a day for 6 consecutive days. The dosage for each group is 2.5mg, 5.0mg, and 6.5mg, respectively. **Intervention Names:** - Drug: GB002 Recombinant Peptide Inhalation Solution - Drug: Placebo **Label:** Multiple Ascending Dose of GB002 Recombinant Peptide Inhalation Solution **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Multiple Ascending Dose of GB002 Recombinant Peptide Inhalation Solution - Single Ascending Dose of GB002 Recombinant Peptide Inhalation Solution **Description:** Inhalation administration **Name:** GB002 Recombinant Peptide Inhalation Solution **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Multiple Ascending Dose of GB002 Recombinant Peptide Inhalation Solution - Single Ascending Dose of GB002 Recombinant Peptide Inhalation Solution **Description:** Inhalation administration **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Other Outcomes **Measure:** GB002 Recombinant Peptide concentrations in induced sputum **Time Frame:** Day 1 to Day 7 #### Primary Outcomes **Measure:** Number of participants with adverse events **Time Frame:** Day 1 to Day 28 #### Secondary Outcomes **Measure:** Plasma GB002 Recombinant Peptide concentrations **Time Frame:** Day 1 to Day 7 **Description:** Anti-drug antibody（ADA）and neutralizing antibody Nab **Measure:** Immunogenicity **Time Frame:** Day 14 and Day 28 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Chinese healthy subjects aged 18 years and above (including 18 years old), both male and female; 2. Male weight ≥50kg, female weight ≥45kg, and body mass index (BMI) in the range of 19-26kg /m² (including the critical value), body mass index (BMI) = weight (kg)/height 2 (m²); 3. Sign informed consent before the test, and fully understand the test content, process and possible adverse reactions; 4. The subjects were able to maintain good communication with the investigators, and understood and complied with the requirements of the clinical trial. Exclusion Criteria: 1. Participants in any drug clinical trial or use of investigational drug within 3 months prior to the use of investigational drug; 2. Have a history of respiratory disease, such as acute exacerbation of chronic obstructive pulmonary disease, pulmonary fibrosis, pulmonary hypertension, pulmonary hydroedema, pulmonary interstitial disease, bronchial asthma, paradoxical bronchospasm, or throat ulcers, edema, or edema, or have undergone throat, trachea/bronchus, or lung surgery, or within 4 weeks prior to the use of the study drug, Patients with a history of upper and lower respiratory tract infection or acute sinusitis caused by viruses or bacteria, which is considered clinically significant by researchers; 3. Patients with a medical history of cardiovascular system, digestive system, endocrine system, urinary system, nervous system, hematology, immunology (including personal or family history of inherited immune deficiency), metabolic abnormalities, and researchers believe that the current clinical significance; 4. Allergy to any of the ingredients of the drug, or a history of allergy to drugs, foods, pollen or other substances, in particular a known allergy to protein foods, or a history of respiratory allergic disease; 5. Patients who cannot tolerate venipunctures or have a history of fainting needles and fainting blood; 6. Patients who have undergone surgery within 6 months prior to the use of the investigational drug that researchers judge will affect drug absorption, distribution, metabolism, and excretion; Or have undergone surgical procedures within 4 weeks prior to the use of the investigational drug; Or plan to undergo surgical procedures during the study period; 7. Used any drug (including prescription drugs, over-the-counter drugs, Chinese herbs, health care products, etc.) within 14 days before the use of the experimental drug; 8. Persons who have received the vaccine or live attenuated vaccine within 14 days prior to the use of the investigational product, or who plan to receive the vaccine during the trial period; 9. People who donated blood or lost a large amount of blood (\>400mL) within 3 months prior to the use of the investigational drug, received blood transfusions or used blood products, or intended to donate blood or blood components during or within 3 months after the end of the trial; 10. Drug abusers or those who have used soft drugs (e.g., cannabis) or hard drugs (e.g., cocaine, PCP, etc.) within one year prior to the use of the investigatory drug; 11. Smokers or smokers who smoked more than 5 cigarettes per day in the 3 months prior to the use of the experimental drug, or who could not stop using any tobacco products during the test period; 12. Alcoholics or regular drinkers in the six months prior to the use of the experimental drug, i.e. drinking more than 14 units of alcohol per week (1 unit =360mL beer or 45mL spirits with 40% alcohol or 150mL wine); Or unwilling to stop drinking alcohol or any products containing alcohol during the trial; 13. Those who consumed excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250mL) per day, or did not agree to stop drinking tea, coffee and/or caffeinated beverages during the study period; 14. Eat any diet (including grapefruit or grapefruit products, dragon fruit, mango, grapefruit, orange, etc.) that may affect the metabolism of the drug in the body within 7 days prior to the use of the investigatory drug, or any other diet that the researcher considers to affect the absorption, distribution, metabolism or excretion of the drug, or do not agree to stop eating the above diet during the trial period; 15. Those who have special requirements for diet and cannot comply with a unified diet; 16. Subjects (or their partners) have pregnancy plans, sperm and egg donation plans, or do not wish to use one or more non-drug contraceptive methods (such as total abstinence, condoms, pregnancy avoidance rings, partner ligation, etc.) during the trial period to 3 months after the trial ends; 17. Female subjects are pregnant or lactating women; Or had unprotected sex within 2 weeks prior to the use of the investigational drug; Use of oral contraceptives within 30 days prior to the use of the investigational drug or use of long-acting estrogen or progesterone injections or implants within 6 months prior to the use of the investigational drug; 18. Patients with clinically significant abnormalities in physical examination, 12-lead electrocardiogram, vital signs (blood pressure, pulse, body temperature, SpO2), chest X-ray, laboratory examination, and pulmonary function examination (as determined by the clinician); 19. Pulmonary function examination: FEV1 measured value /FEV1 estimated value ≤80% or FVC≤ 80% of the estimated value; 20. Positive results of tobacco test; 21. Positive urine screening test; 22. Positive alcohol breath test; 23. Failure to use the inhalant delivery device correctly or unqualified inhalant delivery training; 24. Subjects may not be able to complete the study for other reasons or may have other reasons deemed inappropriate by the investigator. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Changsha **Country:** China **Facility:** The Third Hospital of Changsha **State:** Hunan **Zip:** 410015 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012120 - Term: Respiration Disorders - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M27137 - Name: Respiratory Aspiration - Relevance: HIGH - As Found: Inhalation - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000053120 - Term: Respiratory Aspiration ### 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:** NCT06423248 **Brief Title:** Culinary Spices in Metabolic Syndrome. **Official Title:** The Effect of Therapeutic Doses of Culinary Spices in Metabolic Syndrome: A Randomized Controlled Trial. #### Organization Study ID Info **ID:** Protocol Number: 15/22 #### Organization **Class:** OTHER **Full Name:** United Arab Emirates University ### Status Module #### Completion Date **Date:** 2016-11-13 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2016-11-13 **Type:** ACTUAL #### Start Date **Date:** 2015-05-10 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** United Arab Emirates University #### Responsible Party **Investigator Affiliation:** United Arab Emirates University **Investigator Full Name:** Ayesha Salem Al Dhaheri **Investigator Title:** Professor, Associate Provost, Student Affairs **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This double blind, placebo controlled randomized controlled trial aims to evaluate the effect of three commonly used culinary spices - ginger (Zingiber officinale), cinnamon (Cinnamomum) and black seed (Nigella sativa) on the cardiometabolic parameters of individuals with risk factors of metabolic syndrome. Participants consume their assigned treatment for 12 weeks, and key cardiovascular and glucometabolic parameters are recorded at baseline, week 6, and week 12 of the study. ### Conditions Module **Conditions:** - Metabolic Syndrome ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Masking Description:** Both patient and investigators were blind to treatment allocation, with an independent researcher providing the allocated treatments to the participants. **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 120 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants consumed 3g of dried powdered Ginger (Zingiber officinale) daily for 12 weeks. **Intervention Names:** - Dietary Supplement: Culinary spices **Label:** Ginger **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Participants consumed 3g of dried powdered Cinnamon (Cinnamomum) daily for 12 weeks. **Intervention Names:** - Dietary Supplement: Culinary spices **Label:** Cinnamon **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Participants consumed 3g of dried powdered Black Seed (Nigella sativa) daily for 12 weeks. **Intervention Names:** - Dietary Supplement: Culinary spices **Label:** Black Seed **Type:** ACTIVE_COMPARATOR #### Arm Group 4 **Description:** Participants consumed 3g of powdered corn starch daily for 12 weeks. **Intervention Names:** - Dietary Supplement: Culinary spices **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Black Seed - Cinnamon - Ginger - Placebo **Description:** Powdered culinary spices **Name:** Culinary spices **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Fasting plasma glucose blood test taken at baseline, week 6 and week 12. **Measure:** Mean Change in Fasting Blood Glucose at 12 weeks **Time Frame:** Baseline, Week 6 and Week 12 **Description:** Glycated Haemoglobin blood test taken at baseline, week 6 and week 12. **Measure:** Mean Change in HbA1c at 12 weeks **Time Frame:** Baseline, Week 6 and Week 12 #### Secondary Outcomes **Description:** Systolic and diastolic blood pressure taken at baseline, week 6 and week 12. **Measure:** Mean Change in Blood Pressure at 12 weeks **Time Frame:** Baseline, Week 6 and Week 12 **Description:** Total Cholesterol Blood Test taken at baseline, week 6 and week 12. **Measure:** Mean Change in Total Cholesterol at 12 weeks **Time Frame:** Baseline, Week 6 and Week 12 **Description:** Low Density Lipoprotein Blood Test taken at baseline, week 6 and week 12. **Measure:** Mean Change in LDL Cholesterol at 12 weeks **Time Frame:** Baseline, Week 6 and Week 12 **Description:** High Density Lipoprotein Blood Test taken at baseline, week 6 and week 12. **Measure:** Mean Change in HDL Cholesterol at 12 weeks **Time Frame:** Baseline, Week 6 and Week 12 **Description:** Triglyceride Blood Test taken at baseline, week 6 and week 12. **Measure:** Mean Change in Triglyceride concentrations at 12 weeks **Time Frame:** Baseline, Week 6 and Week 12 **Description:** Weight taken at baseline, week 6 and week 12. **Measure:** Mean Change in Weight at 12 weeks **Time Frame:** Baseline, Week 6 and Week 12 **Description:** Weight taken at baseline, week 6 and week 12, and BMI calculated as weight divided by height squared. **Measure:** Mean Change in Body Mass Index at 12 weeks **Time Frame:** Baseline, Week 6 and Week 12 **Description:** Waist Circumference taken at baseline, week 6 and week 12. **Measure:** Mean Change in Waist Circumference at 12 weeks **Time Frame:** Baseline, Week 6 and Week 12 **Description:** Waist and Hip Circumference taken at baseline, week 6 and week 12, and Waist-Hip ratio calculated. **Measure:** Mean Change in Waist to Hip ratio at 12 weeks **Time Frame:** Baseline, Week 6 and Week 12 **Description:** Dual Energy Xray Absorptiometry performed at baseline, week 6 and week 12, and Fat mass, body fat percentage, visceral fat, fat free mass, and skeletal muscle mass calculated. **Measure:** Mean Change in Densitometric Body Composition at 12 weeks **Time Frame:** Baseline, Week 6 and Week 12 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * age (18-50 years) and had 2 or more of MetS diagnostic criteria: high waist circumference (\>80 cm for female and \>94 cm for males), elevated blood pressure (equal to or greater than 130/85 mm Hg or use of medication for hypertension), high fasting blood glucose (equal to or greater than 100 mg/dL \[5.6 mmol/L\] or use of medication for hyperglycemia), lowered HDL cholesterol (less than 40 mg/dL \[1.03 mmol/L\] for men and less than 50 mg/dL \[1.29 mmol/L\] for women) and increased triglycerides (equal to or greater than 150 mg/dL \[1.7 mmol/L\]). Participants who had at least three risk factors out of five or had two risk factors and one borderline were included in the study. Exclusion Criteria: * did not meet the following inclusion criteria, older than 50 years old or younger than 17 years old and did not meet the metabolic syndrome diagnostic criteria. Additionally, participants were excluded if they are allergic to spices, current smokers, pregnant women, lactating women or currently taking medication and if they refused to provide blood sample. Also, participants with any acute illnesses or any chronic diseases such as kidney, liver, cardiovascular and gastrointestinal diseases were excluded from the study **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Al Ain **Country:** United Arab Emirates **Facility:** United Arab Emirates University **State:** Abu Dhabi ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000007333 - Term: Insulin Resistance - ID: D000006946 - Term: Hyperinsulinism - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M23005 - Name: Metabolic Syndrome - Relevance: HIGH - As Found: Metabolic Syndrome - ID: M10370 - Name: Insulin Resistance - Relevance: LOW - As Found: Unknown - ID: M9997 - Name: Hyperinsulinism - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000024821 - Term: Metabolic Syndrome - ID: D000013577 - Term: Syndrome ### Intervention Browse Module - Browse Branches - Abbrev: HB - Name: Herbal and Botanical - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T166 - Name: Ginger - Relevance: LOW - As Found: Unknown - ID: T238 - Name: Nigella - Relevance: LOW - As Found: Unknown - ID: T115 - Name: Cinnamon - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423235 **Acronym:** ESPTTN **Brief Title:** Efficacy and Safety of Prunella Oral Liquid in the Treatment of Thyroid Nodules **Official Title:** Efficacy and Safety of Prunella Oral Liquid in the Treatment of Thyroid Nodules: a Multicenter, Prospective, Randomized, Double-blind, Placebo-controlled Study #### Organization Study ID Info **ID:** XK-22-A-002-YJ-002 #### Organization **Class:** INDUSTRY **Full Name:** Xintian Pharmaceutical ### Status Module #### Completion Date **Date:** 2028-07-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-04-07 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Xintian Pharmaceutical #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** A multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial was designed to evaluate the efficacy and safety of Prunella oral liquid in patients with benign thyroid nodules, which belongs to the post-marketing reevaluation clinical study. In this study, 426 subjects will be enrolled by competitive enrollment at several research centers across China. The main inclusion criteria are: ① Thyroid ultrasound examination found thyroid nodules, can be accompanied by goiter, and the nodules meet the following conditions: 1) There were dominant nodules in single or multiple nodules (the largest diameter of the second largest nodules was not more than 50% of the largest nodules), 2) solid nodules, 3) the longest diameter of nodules was ≥1cm and \< 3cm, 4) C-TIRADS 3\~4A nodules. ② Patients who met the puncture indication were confirmed by fine needle aspiration biopsy (FNAB) as benign nodules (Bethesda II). ③ Levels of TSH, FT3 and FT4 were normal, and the antibody titers of TgAb and TPOAb were normal. Eligible subjects will be randomly assigned on a 1:1:2:2 scale to: Group A (placebo conventional dose group, 10 mL/times, 2 times/day), group B (placebo 2x dose group, 10ml/times, 2 times/day), group C (conventional dose group of Prunella oral liquid), group D (Prunella oral liquid 2x dose group). All subjects will receive the treatment for 9 months and follow up at 3rd, 6th, 9th and 12th month. The primary efficacy endpoint of this study was the rate of change in thyroid nodule volume from baseline at 6 months of treatment. The rate of change in thyroid nodule volume from baseline at 3 and 9 months of treatment was a secondary efficacy endpoint. Other secondary efficacy endpoints included maximum thyroid nodule diameter, number of thyroid nodules, proportion of patients with reduced thyroid nodule volume or ≥50% from baseline, thyroid volume, thyroid function (serum TSH, FT3, FT4, thyroid egg levels (Tg), thyroid antibody levels (TgAb, TPOAb), quality of life evaluation (SF-36), etc. Safety endpoints included incidence of AE/ serious adverse events (SAE), causality, and outcomes. Incidence of AE/SAE leading to discontinuation. Changes in safety laboratory test values from baseline. ### Conditions Module **Conditions:** - Thyroid Nodule ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 426 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: regular dose of placebo **Label:** placebo regular dose group **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Intervention Names:** - Drug: 2x regular dose of placebo **Label:** placebo 2x regular dose group **Type:** PLACEBO_COMPARATOR #### Arm Group 3 **Intervention Names:** - Drug: regular dose of JiRui® Prunella oral liquid **Label:** regular dose group of Prunella oral liquid group **Type:** ACTIVE_COMPARATOR #### Arm Group 4 **Intervention Names:** - Drug: 2x regular dose of JiRui® Prunella oral liquid **Label:** 2x regular dose group of Prunella oral liquid group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - regular dose group of Prunella oral liquid group **Description:** Take 10ml twice a day **Name:** regular dose of JiRui® Prunella oral liquid **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - 2x regular dose group of Prunella oral liquid group **Description:** Take 20ml twice a day **Name:** 2x regular dose of JiRui® Prunella oral liquid **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - placebo regular dose group **Description:** Take 10ml twice a day **Name:** regular dose of placebo **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - placebo 2x regular dose group **Description:** Take 20ml twice a day **Name:** 2x regular dose of placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Rate of change in thyroid nodule volume from baseline at 6 months of treatment. **Time Frame:** 180 ± 10 days #### Secondary Outcomes **Measure:** Rate of change in thyroid nodule volume from baseline at 3 months of treatment. **Time Frame:** 90 ± 7 days. **Measure:** Rate of change in thyroid nodule volume from baseline at 9 months of treatment. **Time Frame:** 270 ± 14 days. **Measure:** Rate of change in thyroid nodule volume from baseline at 12 months of treatment. **Time Frame:** 360 ± 14 days. **Measure:** The change value of the maximum diameter of thyroid nodules from baseline at 3 months of treatment. **Time Frame:** 90 ± 7 days **Measure:** The change value of the maximum diameter of thyroid nodules from baseline at 6 months of treatment. **Time Frame:** 180 ± 10 days **Measure:** The change value of the maximum diameter of thyroid nodules from baseline at 9 months of treatment. **Time Frame:** 270 ± 14 days **Measure:** The change value of the maximum diameter of thyroid nodules from baseline at 12 months of treatment. **Time Frame:** 360 ± 14 days **Measure:** Proportion of patients with reduced thyroid nodule volume from baseline at 3 months of treatment. **Time Frame:** 90 ± 7 days **Measure:** Proportion of patients with reduced thyroid nodule volume from baseline at 6 months of treatment. **Time Frame:** 180 ± 10 days **Measure:** Proportion of patients with reduced thyroid nodule volume from baseline at 9 months of treatment. **Time Frame:** 270 ± 14 days **Measure:** Proportion of patients with reduced thyroid nodule volume from baseline at 12 months of treatment. **Time Frame:** 360 ± 14 days **Measure:** Proportion of patients with reduced thyroid nodule volume ≥50% from baseline at 3 months of treatment. **Time Frame:** 90 ± 7 days **Measure:** The proportion of patients with reduced thyroid nodule volume ≥50% from baseline at 6 months of treatment. **Time Frame:** 180 ± 10 days **Measure:** Proportion of patients with reduced thyroid nodule volume ≥50% from baseline at 9 months of treatment. **Time Frame:** 270 ± 14 days **Measure:** Proportion of patients with reduced thyroid nodule volume ≥50% from baseline at 12 months of treatment. **Time Frame:** 360 ± 14 days **Measure:** Changes in the number of thyroid nodules from baseline at the 3 months of treatment. **Time Frame:** 90 ± 7 days **Measure:** Changes in the number of thyroid nodules from baseline at the 6 months of treatment. **Time Frame:** 180 ± 10 days **Measure:** Changes in the number of thyroid nodules from baseline at the 9 months of treatment. **Time Frame:** 270 ± 14 days **Measure:** Changes in the number of thyroid nodules from baseline at the 12 months of treatment. **Time Frame:** 360 ± 14 days **Measure:** Proportion of patients with thyroid nodule progression (greater than 50% in volume or greater than 20% in at least 2 diameters from baseline) at 3 months of treatment. **Time Frame:** 90 ± 7 days **Measure:** Proportion of patients with thyroid nodule progression (greater than 50% in volume or greater than 20% in at least 2 diameters from baseline) at 6 months of treatment. **Time Frame:** 180 ± 10 days **Measure:** Proportion of patients with thyroid nodule progression (greater than 50% in volume or greater than 20% in at least 2 diameters from baseline) at 9 months of treatment. **Time Frame:** 270 ± 14 days **Measure:** Proportion of patients with thyroid nodule progression (greater than 50% in volume or greater than 20% in at least 2 diameters from baseline) at 12 months of treatment. **Time Frame:** 360 ± 14 days **Measure:** Rate of change in thyroid volume from baseline at 3 months of treatment. **Time Frame:** 90 ± 7 days **Measure:** Rate of change in thyroid volume from baseline at 6 months of treatment. **Time Frame:** 180 ± 10 days **Measure:** Rate of change in thyroid volume from baseline at 9 months of treatment. **Time Frame:** 270 ± 14 days **Measure:** Rate of change in thyroid volume from baseline at 12 months of treatment. **Time Frame:** 360 ± 14 days **Measure:** Changes in serum TSH, FT3 and FT4 from baseline at the months of treatment. **Time Frame:** 90 ± 7 days **Measure:** Changes in serum TSH, FT3 and FT4 from baseline at the months of treatment. **Time Frame:** 180 ± 10 days **Measure:** Changes in serum TSH, FT3 and FT4 from baseline at 9 months of treatment. **Time Frame:** 270 ± 14 days **Measure:** Changes in serum TSH, FT3 and FT4 from baseline at 12 months of treatment. **Time Frame:** 360 ± 14 days **Measure:** Changes in Tg, TgAb and TPOAb levels from baseline at the 6th month of treatment. **Time Frame:** 180 ± 10 days **Measure:** Proportion of patients with normal thyroid function at 3 months of treatment. **Time Frame:** 90 ± 7 days **Measure:** Proportion of patients with normal thyroid function at 6 months of treatment. **Time Frame:** 180 ± 10 days **Measure:** Proportion of patients with normal thyroid function at 9 months of treatment. **Time Frame:** 270 ± 14 days **Measure:** Proportion of patients with normal thyroid function at 12 months of treatment. **Time Frame:** 360 ± 14 days **Measure:** Subjects' quality of life scores (SF-36) at 3 months of treatment. **Time Frame:** 90 ± 7 days **Measure:** Subjects' quality of life scores (SF-36) at 6 months of treatment. **Time Frame:** 180 ± 10 days **Measure:** Subjects' quality of life scores (SF-36) at 9 months of treatment. **Time Frame:** 270 ± 14 days **Measure:** Subjects' quality of life scores (SF-36) at 12 months of treatment. **Time Frame:** 360 ± 14 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18 years old ≤65 years old; * Thyroid ultrasonography found thyroid nodules, may be accompanied by goiter, and the nodules meet the following conditions: 1) single nodules, or dominant nodules in multiple nodules (the largest diameter of the second largest nodules does not exceed 50% of the largest nodules), 2) solid nodules, 3) the longest diameter of nodules ≥1cm and \< 3cm, 4) C-TIRADS 3\~4A nodules; * Patients who met the puncture indications were confirmed by fine needle aspiration biopsy (FNAB) as benign nodules (Bethesda Class II); * Serum TSH, free thyroid hormone (FT3, FT4) levels were normal, anti-thyroglobulin (TgAb) and anti-thyroid peroxidase (TPOAb) antibody titers were normal; * Meet the diagnostic criteria of thyroid nodules in TCM; * Sign the informed consent. Exclusion Criteria: * Exclude the patients with Deficiency of Yang syndrome, and the following two conditions can be diagnosed: Shortness of breath, abdominal pain and diarrhea, diarrhea with undigested food, Insufficiency with chills, exhaustion and lethargy, pale tongue and white fur, deep and weak pulse * Those who have reproductive needs during pregnancy, lactation and within the last 12 months; * Patients with high possibility of thyroid cancer indicated by ultrasonic signs and malignant confirmed by fine needle biopsy; * Patients who meet the indications for thyroid nodule surgery, such as local compression symptoms obviously related to the nodule, the tumor is located behind the sternum or in the mediastinum, or strongly require surgery due to appearance or ideological concerns affecting normal life; * Patients who have taken prunella preparations or other similar Chinese medicines to treat the disease within the past 1 month; Patients using glucocorticoids in the last 3 months; * Patients who have had or plan to take thyroid hormone, iodine compound, or antithyroid drug therapy during the study period; * Patients who have previously or plan to undergo ablation, neck radiation, surgery and other non-drug treatments during the study period; * Patients with parathyroid tumor (PTA), medullary thyroid cancer (MTC) or other malignant tumors, or patients with serious cardiovascular disease, liver and kidney disease, osteoporosis, or patients with a history of mental illness; * Patients with a family history of thyroid cancer or thyroid cancer syndrome; * Laboratory test index ALT, AST \> 1.5 times the upper limit of reference value or blood creatinine (Scr) \> the upper limit of reference value; * Persons who are known to be allergic to the investigational drug or its ingredients; * Other patients determined by the investigator to be unsuitable for participation in the study. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Wenjing Ji **Phone:** +86 18365572279 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Biao Chen **Phone:** +86 13915637727 **Role:** CONTACT #### Locations **Location 1:** **City:** Chongqing **Contacts:** ***Contact 1:*** - **Name:** Hongting Zheng - **Role:** SUB_INVESTIGATOR **Country:** China **Facility:** Second Hospital of Army Military Medical University **State:** Chongqing **Location 2:** **City:** Xiamen **Contacts:** ***Contact 1:*** - **Name:** Tianchi Hu - **Role:** SUB_INVESTIGATOR **Country:** China **Facility:** Xiamen Hospital of Traditional Chinese Medicine **State:** Fujian **Location 3:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Phone:** （020）83827812 - **Role:** CONTACT ***Contact 2:*** - **Name:** Haixia Guan - **Role:** SUB_INVESTIGATOR **Country:** China **Facility:** People's Hospital of Guangdong Province **State:** Guangdong **Location 4:** **City:** Shenzhen **Contacts:** ***Contact 1:*** - **Name:** Fan Zhang - **Role:** SUB_INVESTIGATOR **Country:** China **Facility:** Shenzhen Hospital of Peking University **State:** Guangdong **Location 5:** **City:** Shunde **Contacts:** ***Contact 1:*** - **Phone:** 0757-22318000 - **Role:** CONTACT ***Contact 2:*** - **Name:** Jie Shen - **Role:** SUB_INVESTIGATOR **Country:** China **Facility:** Shunde Hospital of Southern Medical University **State:** Guangdong **Location 6:** **City:** Wuhan **Contacts:** ***Contact 1:*** - **Name:** Mingsong Gao - **Role:** SUB_INVESTIGATOR **Country:** China **Facility:** Wuhan First Hospital **State:** Hubei **Location 7:** **City:** Nanjing **Contacts:** ***Contact 1:*** - **Name:** Chao Liu - **Role:** SUB_INVESTIGATOR **Country:** China **Facility:** Jiangsu Province Hospital of Integrated Chinese and Western Medicine **State:** Jiangsu **Location 8:** **City:** Xuzhou **Contacts:** ***Contact 1:*** - **Name:** Hongwei Lin - **Role:** SUB_INVESTIGATOR **Country:** China **Facility:** Xuzhou Medical University Hospital **State:** Jiangsu **Location 9:** **City:** Dalian **Country:** China **Facility:** The Second Hospital of Dalian Medical University **State:** Liaoning **Location 10:** **City:** Shenyang **Contacts:** ***Contact 1:*** - **Name:** Yuqing Li - **Phone:** +86 15140139773 - **Role:** CONTACT ***Contact 2:*** - **Name:** Zhongyan Shan - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** The First Hospital of China Medical University **State:** Liaoning **Zip:** 200032 **Location 11:** **City:** Shenyang **Contacts:** ***Contact 1:*** - **Phone:** 82961387 - **Role:** CONTACT ***Contact 2:*** - **Name:** Tianshu Gao - **Role:** SUB_INVESTIGATOR **Country:** China **Facility:** Hospital of Liaoning University of Chinese Medicine **State:** Liaoning **Location 12:** **City:** Shenyang **Contacts:** ***Contact 1:*** - **Phone:** 024-24016001 - **Role:** CONTACT ***Contact 2:*** - **Name:** Binhong Wen - **Role:** SUB_INVESTIGATOR **Country:** China **Facility:** People's Hospital of Liaoning Province **State:** Liaoning **Location 13:** **City:** Qingdao **Contacts:** ***Contact 1:*** - **Name:** Jie Zhu - **Role:** CONTACT ***Contact 2:*** - **Name:** Yangang Wang - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** The First Hospital of Qingdao University **State:** Shandong **Location 14:** **City:** Weifang **Contacts:** ***Contact 1:*** - **Phone:** 963360 - **Role:** CONTACT ***Contact 2:*** - **Name:** Haixia Liu - **Role:** SUB_INVESTIGATOR **Country:** China **Facility:** Weifang People's Hospital **State:** Shandong **Location 15:** **City:** Weihai **Contacts:** ***Contact 1:*** - **Phone:** 0631-5287120 - **Role:** CONTACT ***Contact 2:*** - **Name:** Yachao Yang - **Role:** SUB_INVESTIGATOR **Country:** China **Facility:** Weihai Hospital **State:** Shandong **Location 16:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Phone:** 02163864050-510905 - **Role:** CONTACT ***Contact 2:*** - **Name:** Dongjie Shen - **Role:** SUB_INVESTIGATOR **Country:** China **Facility:** Ruijin Hospital Luwan Branch, Shanghai Jiao Tong University School of Medicine **State:** Shanghai **Location 17:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Name:** Shen Qu - **Role:** SUB_INVESTIGATOR **Country:** China **Facility:** Shanghai 10th People's Hospital **State:** Shanghai **Location 18:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Name:** Yongde Peng - **Role:** SUB_INVESTIGATOR **Country:** China **Facility:** Shanghai First People's Hospital **State:** Shanghai **Location 19:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Name:** Jin'an Zhang - **Role:** SUB_INVESTIGATOR **Country:** China **Facility:** Shanghai Pudong Zhoupu Hospital **State:** Shanghai **Location 20:** **City:** Kunming **Contacts:** ***Contact 1:*** - **Name:** Heng Su - **Role:** SUB_INVESTIGATOR **Country:** China **Facility:** First People's Hospital of Yunnan Province **State:** Yunnan **Location 21:** **City:** Kunming **Contacts:** ***Contact 1:*** - **Phone:** 0871-65324888 - **Role:** CONTACT ***Contact 2:*** - **Name:** Yushan Xu - **Role:** SUB_INVESTIGATOR **Country:** China **Facility:** The First Hospital of Kunming Medical University **State:** Yunnan **Location 22:** **City:** Hangzhou **Contacts:** ***Contact 1:*** - **Name:** Xin Mu - **Role:** SUB_INVESTIGATOR **Country:** China **Facility:** Zhejiang Province Hospital of Integrated Chinese and Western Medicine **State:** Zhejiang ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004700 - Term: Endocrine System Diseases - ID: D000013964 - Term: Thyroid Neoplasms - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000006258 - Term: Head and Neck Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms ### Condition Browse Module - Browse Leaves - ID: M16718 - Name: Thyroid Diseases - Relevance: HIGH - As Found: Thyroid - ID: M18986 - Name: Thyroid Nodule - Relevance: HIGH - As Found: Thyroid Nodules - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M16723 - Name: Thyroid Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016606 - Term: Thyroid Nodule - ID: D000013959 - Term: Thyroid Diseases ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423222 **Brief Title:** Anal Incontinence and Its Impact on Quality of Life and Physical Activity Among Hungarian Women and the Hungarian Language Validation of the International Consultation on Incontinence Modular Questionnaire-Bowels (ICIQ-B) **Official Title:** Prevalence of Anal Incontinence and Its Impact on Quality of Life and Physical Activity Among Hungarian Women Who Have Given Birth, and the Hungarian Language Validation of the International Consultation on Incontinence Modular Questionnaire-Bowels (ICIQ-B) #### Organization Study ID Info **ID:** BM/5814-3/2024 #### Organization **Class:** OTHER **Full Name:** University of Pecs ### Status Module #### Completion Date **Date:** 2027-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-22 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-05 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Pecs #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of the study is to assess the prevalence of anal incontinence among Hungarian women who have given birth at least once before, and to examine the impact of anal incontinence on the quality of life and physical activity of these women. A further aim of our study is to adapt the Hungarian version of the International Consultation on Incontinence Modular Questionnaire - Bowels (ICIQ-B) and to assess its validity and reliability. ### Conditions Module **Conditions:** - Anal Incontinence **Keywords:** - Anal Incontinence - Quality of Life - Physical Activity - Questionnaire ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 250 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Assessing with questionnaire: International Consultation on Incontinence Modular Questionnaire-Bowels (ICIQ-B). The ICIQ-B is a patient-completed questionnaire to assess the symptoms and impact on quality of life (QoL) of anal incontinence (including flatus incontinence). The ICIQ-B consists of 21 items, divided into three domains: Bowel pattern (1 - 21), bowel control (0 - 28), Quality of life (0 - 26). Seventeen items are scored items and the remaining four are unscored. Higher scores indicate more symptoms. **Measure:** Anal Incontinence Impact on Quality of Life **Time Frame:** Through study completion, an average of 3 years **Description:** Assessing with questionnaire: Global Physical Activity Questionnaire (GPAQ). The Global Physical Activity Questionnaire was developed by WHO to monitor physical activity in countries. It collects information from 16 questions (P1-P16) on participation in physical activity in three domains (Workplace activity, Travel to and from places, Leisure activities) and sedentary behavior. Metabolic equivalent (MET) values are applied to the time variables according to the intensity of the activity (moderate or high). The application of MET values to activity levels allows the calculation of total physical activity. **Measure:** Anal Incontinence Impact on Physical Activity **Time Frame:** Through study completion, an average of 3 years **Description:** Evaluating with statistical analysis the content/face validity, internal consistency, construct validity, test-retest reproducibility, discriminant validity and convergent validity. **Measure:** Adaptation, validity and reliability of the Hungarian version of the International Consultation on Incontinence Modular Questionnaire-Bowels (ICIQ-B) **Time Frame:** Through study completion, an average of 3 years #### Secondary Outcomes **Description:** Assessing with questionnaire: The Hungarian version of the Australian Pelvic Floor Questionnaire (APFQ-H). The APFQ-H consists of four domains: bladder function (15 items), bowel function (12 items), prolapse symptoms (5 items) and sexual function (10 items). Thirty-eight of the items assess pelvic floor symptoms and four questions assess the bother caused by symptoms in each domain. Most items in the questionnaire use a 4-point scoring system. The score obtained for each domain ranges from 0 to 10. The sum of the subscores in the four domains gives the APFQ-H global score. The higher the score, the more severe the pelvic floor symptoms. **Measure:** Additional pelvic floor symptoms **Time Frame:** Through study completion, an average of 3 years **Description:** Assessing with questionnaire: Hungarian WHOQOL-BREF. The WHOQOL-BREF is a self-administered questionnaire that contains 26 questions about an individual's health and well-being over the previous two weeks. Answers to the questions are given on a Likert scale of 1-5. The WHOQOL-BREF covers four domains (physical health, psychological, social relationships, environment). Scores in each of the 4 domains are converted into a scale ranging from 0 to 100. A score of 0 represents the worst possible health status, while a score of 100 represents the best possible health status for that domain. **Measure:** Global Quality of Life **Time Frame:** Through study completion, an average of 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Have given birth at least once before * Native Hungarian language Exclusion Criteria: * Menopause * Irritable Bowel Syndrome (IBS) * Chron's disease * Ulcerative colitis * Developmental abnormalities at the level of the pelvic organs * Uninvestigated pelvic pain * Malignant pelvic tumor * Radiotherapy involving the pelvis * Neurological diseases with muscle weakness * Parkinson's disease * Intellectual disability **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT **Study Population:** We plan to include subjects who are female, over the age of 18, under the age of 50 and who have given birth at least once before. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Márta Hock, PhD **Phone:** +36-30-7213156 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Eszter Ambrus **Role:** CONTACT #### Locations **Location 1:** **City:** Pécs **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Márta Hock, Phd - **Phone:** +36-30-7213156 - **Role:** CONTACT **Country:** Hungary **Facility:** Doctoral School of Health Sciences, Faculty of Health Sciences, University of Pécs **State:** Baranya **Status:** RECRUITING **Zip:** H-7621 #### Overall Officials **Official 1:** **Affiliation:** University of Pécs Faculty of Health Sciences **Name:** Márta Hock, PhD **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Doctoral School of Health Sciences, Faculty of Health Sciences, University of Pécs, Pécs, Hungary **Name:** Eszter Ambrus **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012002 - Term: Rectal Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M8381 - Name: Fecal Incontinence - Relevance: HIGH - As Found: Anal Incontinence - ID: M14844 - Name: Rectal Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life ### Condition Browse Module - Meshes - ID: D000005242 - Term: Fecal Incontinence ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423209 **Acronym:** Vegan **Brief Title:** Efficacy of a Training Program in Adults Following a Vegan Diet Versus an Omnivorous Diet **Official Title:** Efficacy of an Omnivorous Versus a Vegan Diet in the Prevention or Treatment of Sarcopenia in Chilean Adults Following a Strength Training Program #### Organization Study ID Info **ID:** CEBB 1068-2021 #### Organization **Class:** OTHER **Full Name:** Universidad de Concepcion ### Status Module #### Completion Date **Date:** 2022-10-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-05-02 **Type:** ACTUAL #### Start Date **Date:** 2022-02-02 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universidad de Concepcion #### 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 consisted of a non-randomized controlled clinical trial with measurements at baseline and at the end of a 16 week intervention. Participants will be assigned to the intervention or control group according to their own choice and convenience. A 4 arm split was performed where the Veg-Int group was composed of people on a vegan diet who participated in the intervention, the Veg-Con group was composed of people on a vegan diet who were part of the control group, the Omn-Int group was composed of people on an omnivorous diet who participated in the intervention, and the Omn-Con group was composed of people on an omnivorous diet who were part of the control group. The Veg-Int and Omn-Int intervention groups, participated in a physical exercise program in remote modality through a digital mHealth platform. During the 16 weeks of intervention, a total of 50 training sessions were carried out, distributed in three sessions per week, with a duration per session ranging from 40 to 50 minutes. The exercise program was designed and supervised by a physical education teacher and focused on strength training using body weight exercises targeting the major muscle groups, including upper body, lower body and abdominals. The platform recorded participants attendance and the time they spent on each exercise session. At the end of the sessions, participants had the option to evaluate and share their perception of effort during the workout through a Modified Borg scale (0-10). In addition, they were given the opportunity to communicate with the teacher via phone call, text message or e-mail, to receive feedback or raise doubts. **Detailed Description:** All participants were evaluated in weeks 0 and 17, immediately after the intervention program, under the same conditions in terms of protocol, calibrated instruments and the same evaluator. The evaluation of nutritional status was carried out using the body mass index (BMI, Kg/m2), while the waist circumference was measured by passing a measuring tape at the height of the navel, midpoint between the costal margin and the crest. iliac, at the end of a normal expiration and recorded in centimeters. Body composition analysis was obtained by the bioimpedance method, using a segmented bioimpedance meter. The measurements were carried out under fasting conditions for at least 4 hours, without having performed physical exercise in the last 12 hours, without consuming stimulating drinks such as caffeine and avoiding the menstrual period. From the body composition information, the data Percentage of Fat Mass, Kilos of Fat Mass and Kilos of Lean Mass were recorded. The level of physical activity was assessed through a self-report questionnaire of physical activity and sitting time in the last 7 days, using the abbreviated version of the International Physical Activity Questionnaire (. The questionnaire was administered by a physical activity professional, and the data were reported in minutes per day to estimate the total PA performed, and the time reported was corrected by its metabolic equivalent . The type of diet was corroborated through a quantified food consumption trend survey, which included 14 groups; vegetables, fruits, dairy and vegetable options, meat-fish-seafood and egg, legumes, vegan protein preparations, grains and cereals, fats and oils, nuts, sugars and sweets, alcohol, snacks, coffee and infusions, food supplements. The questionnaire was administered individually by a dietitian nutritionist to each participant. ### Conditions Module **Conditions:** - Physical Activity **Keywords:** - vegan diet - omnivorous diet - strength training ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The study consisted of a 4-arm non-randomized controlled clinical trial, with measurements at the beginning and end of a 16-week intervention. ##### Masking Info **Masking:** DOUBLE **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 83 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The intervention group is composed of people who follow a vegan diet and who will be part of an intervention program for 16 weeks, consisting of a physical exercise program of strength resistance with 3 sessions per week. Each session will be guided by a physical activity professional and will last from 45 to 50 minutes. **Intervention Names:** - Other: Strength training program **Label:** Vegan Intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The intervention group is composed of people who follow a omnivorous diet and who will be part of an intervention program for 16 weeks, consisting of a physical exercise program of strength resistance with 3 sessions per week. Each session will be guided by a physical activity professional and will last from 45 to 50 minutes. **Intervention Names:** - Other: Strength training program **Label:** omnivorous intervention **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** People who follow an vegan diet who were part of the control group. They were evaluated before and after the intervention. **Label:** vegan control **Type:** NO_INTERVENTION #### Arm Group 4 **Description:** People who follow an omnivorous diet who were part of the control group. They were evaluated before and after the intervention. **Label:** omnivorous control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Vegan Intervention - omnivorous intervention **Description:** Strength training program to be developed during 16 weeks. There will be 3 exercise sessions per week and those participants who perform at least 2 sessions during the program will be considered for the statistical analysis. **Name:** Strength training program **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Differential between kg of body weight before and after the development of the intervention **Measure:** Body weight **Time Frame:** 16 weeks of intervention **Description:** Differential between centimeters of waist circumference before and after the development of the intervention **Measure:** waist circumference **Time Frame:** 16 weeks of intervention **Description:** Differential of the percentage of fat mass before and after the intervention **Measure:** fat mass **Time Frame:** 16 weeks of intervention **Description:** Differential of kilograms of lean mass before and after the intervention **Measure:** Lean mass **Time Frame:** 16 weeks of intervention **Description:** Differential of kilograms of maximum strength by biceps curl exercise **Measure:** maximum strength **Time Frame:** 16 weeks of intervention **Description:** Differential of manual grip strength of both hands using a hydraulic dynamometer. **Measure:** Manual grip strength **Time Frame:** 16 weeks of intervention **Description:** Differential evaluation of muscle power by means of a vertical jump **Measure:** Vertical jump **Time Frame:** 16 weeks of intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria:People between 18 and 59 years old who follow a vegan or omnivorous diet for at least the last 6 months prior to the study. - Exclusion Criteria: Those who were doing strength training or doing less than 3 hours of vigorous exercise per week did not have health compatible with the activities of this study. People with a diagnosis of diabetes, uncontrolled hypertension (Systolic Blood Pressure ≥150 and/or Diastolic Blood Pressure ≥90 mmHg). People who were undergoing treatment for cancer, chronic kidney failure, or who reported a health problem in the previous fitness for physical activity questionnaire (PAR-Q). - **Healthy Volunteers:** True **Maximum Age:** 59 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Concepción **Country:** Chile **Facility:** Richar Carcamo Regla **State:** Concepcion **Zip:** 4030000 #### Overall Officials **Official 1:** **Affiliation:** Universidad de Concepcion **Name:** Rafael E Zapata Lamana, Doctor **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** Has not been considered or discussed yet **IPD Sharing:** NO ### References Module #### References **Citation:** Boutros GH, Landry-Duval MA, Garzon M, Karelis AD. Is a vegan diet detrimental to endurance and muscle strength? Eur J Clin Nutr. 2020 Nov;74(11):1550-1555. doi: 10.1038/s41430-020-0639-y. Epub 2020 Apr 24. **PMID:** 32332862 **Citation:** Hevia-Larrain V, Gualano B, Longobardi I, Gil S, Fernandes AL, Costa LAR, Pereira RMR, Artioli GG, Phillips SM, Roschel H. High-Protein Plant-Based Diet Versus a Protein-Matched Omnivorous Diet to Support Resistance Training Adaptations: A Comparison Between Habitual Vegans and Omnivores. Sports Med. 2021 Jun;51(6):1317-1330. doi: 10.1007/s40279-021-01434-9. Epub 2021 Feb 18. **PMID:** 33599941 **Citation:** Reid-McCann RJ, Brennan SF, McKinley MC, McEvoy CT. The effect of animal versus plant protein on muscle mass, muscle strength, physical performance and sarcopenia in adults: protocol for a systematic review. Syst Rev. 2022 Apr 13;11(1):64. doi: 10.1186/s13643-022-01951-2. **PMID:** 35418173 **Citation:** van de Brekel JA, Duurkens VA, Vanderschueren RG. Pneumothorax. Results of thoracoscopy and pleurodesis with talc poudrage and thoracotomy. Chest. 1993 Feb;103(2):345-7. doi: 10.1378/chest.103.2.345. **PMID:** 8432116 **Citation:** Hannaian SJ, Churchward-Venne TA. Meatless Muscle Growth: Building Muscle Size and Strength on a Mycoprotein-Rich Vegan Diet. J Nutr. 2023 Jun;153(6):1665-1667. doi: 10.1016/j.tjnut.2023.04.011. Epub 2023 Apr 14. No abstract available. **PMID:** 37062484 **Citation:** Pohl A, Schunemann F, Bersiner K, Gehlert S. The Impact of Vegan and Vegetarian Diets on Physical Performance and Molecular Signaling in Skeletal Muscle. Nutrients. 2021 Oct 29;13(11):3884. doi: 10.3390/nu13113884. **PMID:** 34836139 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M28396 - Name: Sarcopenia - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423196 **Brief Title:** Upper Limb Blood Flow Restriction in Handball Players **Official Title:** Efficacy of Upper Limb Blood Flow Restriction in Handball Players. Randomised Clinical Study #### Organization Study ID Info **ID:** Floss-Hand #### Organization **Class:** OTHER **Full Name:** Universidad Católica San Antonio de Murcia ### Status Module #### Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-06-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-19 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universidad Católica San Antonio de Murcia #### Responsible Party **Investigator Affiliation:** Universidad Católica San Antonio de Murcia **Investigator Full Name:** Rubén Cuesta-Barriuso, PhD **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Introduction. Blood flow restriction therapy involves the use of an occlusion cuff placed over an extremity resulting in a partial reduction of arterial blood flow and total restriction of venous return. Objectives. To analyse the efficacy of a physiotherapy intervention using blood flow restriction in improving upper limb strength in adult handball players. Methods. Randomised, single-blind, clinical study. 20 athletes will be recruited and randomly assigned to the experimental and control groups. The intervention of the experimental group will consist of performing an exercise protocol after blood flow restriction. The intervention period will last 4 weeks, with a periodicity of 2 weekly sessions of 30 minutes each. The primary variable will be the strength of the triceps, epicondyle and epitrochlear musculature (pressure hand dynamometer). The secondary variable will be the muscle activation of this musculature (surface electromyography). ### Conditions Module **Conditions:** - Sports Physical Therapy **Keywords:** - Handball - Blood flow restriction - Muscle strength - Muscle activation - Upper limbs - Physiotherapy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Masking Description:** Three assessments will be made throughout the study: before the intervention (T0), after the experimental phase (T1) and after a 4-week follow-up period (T2). All variables will be assessed by an evaluator blinded to the assignment of the athletes to the study groups. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The intervention of the experimental group will consist of performing an exercise protocol after carrying out the blood flow restriction. A total of 6 muscle strength exercises will be performed for the proximal (triceps brachii) and forearm (epitrochlear and epicondylar muscles). **Intervention Names:** - Other: Experimental group **Label:** Experimental group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients included in the control group will continue with their pre-study training and activities, without modifying their routine. **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental group **Description:** In the development of the exercises, the players will mobilise dumbbells of different weights that will be estimated according to the calculation of 30% of 1 RM. This workload with dumbbells is based on previous work where blood flow restriction was used in healthy athletes. **Name:** Experimental group **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Muscle strength will be assessed with a pressure dynamometer (Lafayette Manual Muscle model). The strength of the triceps brachii, epicondyle and epitrochlear musculature will be measured. The evaluation protocol used by Morin et al. will be used. The unit of measurement is the Newton (the higher the value, the greater the muscle strength). The measurements are taken bilaterally. The mean value of the 2 measurements taken shall be used as a measure. **Measure:** Assess the muscle strength at screening visit **Time Frame:** Screening visit, within the first seven days after treatment and after four weeks follow-up #### Secondary Outcomes **Description:** Muscle activation will be measured by surface electromyography (model SHIMMMER2, Shimmer, Ireland). Electrode placement will be marked on standing subjects, and will be positioned according to European recommendations for the use of surface electromyography. A bipolar SEMG system will be used with circular electrodes of 10 mm diameter, 20 mm apart, placed longitudinally, in the direction of the muscle fibres under study, and with a reference electrode at a distance. The unit of measurement is µV, where the higher the score, the greater the muscle activation. **Measure:** Assess the muscle activation at screening visit **Time Frame:** Screening visit, within the first seven days after treatment and after four weeks follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Athletes over 18 years of age. * Federated in handball at the time of the study. * No lower limb injuries in the three months prior to the study. * Signing the informed consent document. Exclusion Criteria: * Athletes who have undergone surgery in the year prior to the study. * People who do not attend at least 80% of the treatment sessions. * Players who are receiving physiotherapy treatment in parallel to the physical preparation of the team they are playing for. **Healthy Volunteers:** True **Maximum Age:** 30 Years **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Rubén Cuesta-Barriuso, PhD **Phone:** 607547274 **Role:** CONTACT #### Locations **Location 1:** **City:** Murcia **Country:** Spain **Facility:** Universidad Católica San Antonio, Murcia **Zip:** 30107 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423183 **Acronym:** IMPACT **Brief Title:** Interprofessional Mindfulness Practices Advancing Cancer Teamwork **Official Title:** Interprofessional Mindfulness Practices Advancing Cancer Teamwork (IMPACT Study) #### Organization Study ID Info **ID:** 2024-0517 #### Organization **Class:** OTHER **Full Name:** University of Wisconsin, Madison #### Secondary ID Infos **Domain:** UW Madison **ID:** A539713 **Type:** OTHER **Domain:** UW Madison **ID:** Protocol Version **Type:** OTHER ### Status Module #### Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### 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 ### Description Module **Brief Summary:** The purpose of the research is to understand if mindfulness team training can improve the well-being and teamwork in caring for oncology patients. This study will enroll healthcare professionals in oncology teams, including clinic nurses, nurse managers, medical assistants, social workers, technicians, patient navigators, advanced practice providers, and physicians at UW Madison. Participants will be on study for up to approximately 6 months. **Detailed Description:** Aim 1: Determine the effect of resilience training on team resilience and well-being. The investigators test the hypothesis that resilience training provided to interprofessional oncology care teams will improve team resilience and individual well-being. Aim 2: Determine the feasibility and acceptability of a resilience training on team resilience. The investigators test the hypothesis that resilience training is feasible and acceptable in interprofessional oncology care teams. ### Conditions Module **Conditions:** - Burn Out **Keywords:** - oncology - health care - clinicians - mindfulness - well-being ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** This study is a prospective, pre-post study at a single institution ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: A Mindful Approach to Building a Resilient Healthcare Workforce (RENEW) **Label:** Mindfulness-Based Team Resilience Training **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Mindfulness-Based Team Resilience Training **Description:** Synchronous, 4-month intervention that teaches skills in mindfulness, stress management, and resilience as an individual and as a team. Sessions occur monthly and include a 1 hour in-person introductory session followed by 3 50-minute virtual sessions. **Name:** A Mindful Approach to Building a Resilient Healthcare Workforce (RENEW) **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** 4-item Edmondson's psychology safety scale is scored on a likert scale from 1 (strongly disagree) to 7 (strongly agree), where higher scores indicate higher psychology safety **Measure:** Change in Teamwork Measure **Time Frame:** baseline (pre-intervention), post-intervention (3 months), follow up (6 months) **Description:** Session 1 baseline, session 2 at 1 month, session 3 at 2 months, session 4 at 3 months **Measure:** Number of Participants Who Attend Each Session **Time Frame:** up to 3 months **Description:** AIM is a 4-item survey scored on a 5 point likert scale from 1 (completely disagree) to 5 (completely agree), where higher scores indicate greater acceptability. **Measure:** Acceptability of Intervention Measure (AIM) **Time Frame:** up to 3 months **Description:** IAM is a 4-item survey scored on a 5 point likert scale from 1 (completely disagree) to 5 (completely agree), where higher scores indicate greater appropriateness. **Measure:** Intervention Appropriateness Measure (IAM) **Time Frame:** up to 3 months **Description:** FIM is a 4-item survey scored on a 5 point likert scale from 1 (completely disagree) to 5 (completely agree), where higher scores indicate greater feasibility. **Measure:** Feasibility of Intervention Measure (FIM) **Time Frame:** up to 3 months #### Secondary Outcomes **Description:** PSS is a 10-item survey scored from 0 (never) to 4 (very often) for a total possible range of scores from 0-40 where higher scores indicate higher perceived stress. **Measure:** Change in Stress measured by Perceived Stress Scale (PSS) **Time Frame:** baseline (pre-intervention), post-intervention (3 months), follow up (6 months) **Description:** This is a 2-item survey scored from 0-6 where higher scores indicate increased burnout. **Measure:** Change in Burnout measured by Maslach Burnout Inventory **Time Frame:** baseline (pre-intervention), post-intervention (3 months), follow up (6 months) **Description:** CD-RISC 2 is a 2-item survey each scored on a 5 point likert scale from 0 (not true at all) to 4 (true nearly all of the time), higher scores indicate increased resilience. **Measure:** Change in Resilience measured by Connor Davidson Resilience Scale (CD-RISC 2) **Time Frame:** baseline (pre-intervention), post-intervention (3 months), follow up (6 months) **Description:** Flourishing measure is a 12-item survey that measure well being in each of 6 domains: happiness and life satisfaction; mental and physical health; meaning and purpose; character and virtue; close social relationships; financial and material stability. Each domain is scored from 0 - 10 where higher numbers are indicative of increased well being. **Measure:** Change in Well-being measured by Flourishing Index **Time Frame:** baseline (pre-intervention), post-intervention (3 months), follow up (6 months) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * A care provider in an oncology clinic team (clinic nurse, nurse manager, medical assistant, technician, social worker, patient navigator, advanced practice provider, physician) Exclusion Criteria: * Does not participate in patient care or support services **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Syndey Tan, MD **Phone:** 608-263-7502 **Role:** CONTACT #### Locations **Location 1:** **City:** Madison **Country:** United States **Facility:** UW Carbone Cancer Center **State:** Wisconsin **Zip:** 53792 #### Overall Officials **Official 1:** **Affiliation:** UW Carbone Cancer Center **Name:** Lee Wilke, MD, FACS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013315 - Term: Stress, Psychological - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M5326 - Name: Burns - Relevance: LOW - As Found: Unknown - ID: M1658 - Name: Burnout, Psychological - Relevance: HIGH - As Found: Burn Out - ID: M16105 - Name: Stress, Psychological - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000077062 - Term: Burnout, Psychological ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423170 **Brief Title:** A Single-arm Phase II Clinical Study of the Efficacy and Safety of Camrelizumab Combined With GEMOX for Unresectable GBCs **Official Title:** Camrelizumab Plus Gemcitabine and Oxaliplatin (GEMOX) in Patients for Unresectable Gallbladder Cancer: a Single-arm, Phase II Trial #### Organization Study ID Info **ID:** SYSKY-2022-516 #### Organization **Class:** OTHER **Full Name:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-06-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 was to evaluate the efficacy and safety of Camrelizumab combined with gemcitabine and oxaliplatin (GEMOX) for unresectable gallbladder cancer. Patients with unresectable gallbladder cancer were enrolled to receive gemcitabine 1000mg/m2 D1+oxaliplatin 100mg/m2, D1+Camrelizumab 200mg, D1, in 21-day cycles for 6-8 cycles, with serum tumour markers assessed at each course and abdominal CTA performed every two courses, until tumour progression occurs.The primary indicators of this study are radical tumor resection rate; secondary indicators are disease control rate, objective response rate,progression-free survival and overall survival; safety indicators: incidence and severity of adverse events (AEs) and serious adverse events (SAEs) according to NCI-CTCAEv5.0 criteria. 37 patients are expected to be recruited for this study. ### Conditions Module **Conditions:** - Unresectable Gallbladder Cancer **Keywords:** - PD-1；GEMOX；Unresectable gallbladder cancer. ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 37 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Camrelizumab plus GEMOX was given as conversion therapy for unresectable gallbladder cancer **Intervention Names:** - Drug: Camrelizumab plus GEMOX **Label:** Camrelizumab plus GEMOX **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Camrelizumab plus GEMOX **Description:** 1. Camrelizumab：200mg，D1，intravenous infusion, the administration time is 60 (+15) minutes. 2. GEMOX chemotherapy : oxaliplatin 100mg/m2，D1, gemcitabine1000mg/m2，D1，intravenous infusion. 3. Carrilizumab and GEMOX chemotherapy will be intravenous infused atone day. Three weeks is a course of treatment,a total of 6-8 courses. **Name:** Camrelizumab plus GEMOX **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The proportion of patients with negative surgical resection margins in the study group **Measure:** radical tumor resection rate **Time Frame:** 6 months #### Secondary Outcomes **Description:** The proportion of patients whose tumours shrink or remain stable for a certain period of time and includes cases of complete remission (CR), partial remission (PR) and stable (SD). **Measure:** Disease Control Rate，DCR **Time Frame:** 6 months **Description:** The time between the start of treatment for disease and the observation of disease progression or the occurrence of death from any cause **Measure:** Progress Free Survival，PFS **Time Frame:** 6 months **Description:** The time between the start of the diagnosis of unresectable gallbladder cancerand death from any cause **Measure:** Overall Survival，OS **Time Frame:** 6 months **Description:** The proportion of patients whose tumour volume shrinks to a pre-defined value and who are able to maintain the minimum time requirement is the sum of the proportion in complete remission (CR) and partial remission (PR) **Measure:** Objective response rate，ORR **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients aged 18-75 years 2. Patients with unresectable gallbladder cancer clearly diagnosed by puncture pathology or the presence of tumour cells in the bile 3. No history of chemotherapy or immunotherapy 4. ECOG score 0-1 within 1 week prior to enrollment 5. Expected survival \> 3 months 6. The functional indicators of important organs meet the following requirements： (1)Neutrophils≥1.5\*109/L; platelets≥100\*109/L; hemoglobin≥9g/dl; serum albumin≥3g/dl; (2)Thyroid-stimulating hormone (TSH) ≤ 2 times the upper limit of normal, and T3 and T4 are in the normal range; (3)Bilirubin ≤ 1.5 times the upper limit of normal; ALT and AST ≤ 3 times the upper limit of normal; (4)Serum creatinine ≤ 1.5 times the upper limit of normal, and creatinine clearance ≥ 60ml/min(calculated by Cockcroft-Gault formula); 7. Female subjects of childbearing potential must have had a negative serum pregnancy study within 14 days prior to the start of study treatment and be willing to use a reliable method of contraception during the study and for 60 days after the final administration of study drug 8. Male subjects whose partner is a woman of childbearing age should agree to use a reliable method of contraception for the duration of the study and for 120 days after the last dose of study drug 9. Subjects who voluntarily enter the study, sign an informed consent form, are compliant and willing to cooperate with follow-up Exclusion Criteria: 1. Past or simultaneous suffering from other malignant tumors, except for fully treated non-melanoma skin cancer, cervical carcinoma in situ, and thyroid papillary carcinoma; 2. Have used gemcitabine-based chemotherapy or have used PD-1 monoclonal antibody or PD-L1 monoclonal antibody treatment within 6 months; 3. Severe cardiopulmonary and renal dysfunction; 4. Hypertension that is difficult to control with drugs (systolic blood pressure (BP) ≥140 mmHg and/or diastolic blood pressure≥90mmHg) (based on the average of ≥3 BP readings obtained by ≥2measurements); 5. Abnormal coagulation function (PT\>14s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy; 6. After antiviral treatment, HBV DNA\>2000 copies/ml, HCV RNA\>1000; 7. A history of esophageal and gastric varices, significant clinically significant bleeding symptoms or a clear tendency to appear within 3 months before enrollment; 8. Active infections requiring systemic treatment; patients with active tuberculosis infection within 1 year before enrollment; a history of active tuberculosis infection more than 1 year before enrollment, and no formal anti-tuberculosis treatment or tuberculosis Still in the active period; 9. Human immunodeficiency virus (HIV, HIV1/2 antibody) positive; 10. A history of psychotropic drug abuse, alcohol or drug abuse; 11. Known to have a history of severe allergies to any monoclonal antibodies, platinum drugs, or gemcitabine; 12. Other factors judged by the investigator may affect the safety of the subjects or the compliance of the trial. Such as serious diseases (including mental illness) that require combined treatment, serious laboratory abnormalities, or other family or social factors. - **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Zhang Rui, PhD **Phone:** 020-34078840 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Ye Yanfang **Phone:** 02081332587 **Role:** CONTACT #### Locations **Location 1:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Zhang Rui, PhD - **Phone:** 020-34078840 - **Role:** CONTACT **Country:** China **Facility:** Sun Yat-sen Memorial Hospital, Sun Yat-sen University **State:** Guangdong **Status:** RECRUITING **Zip:** 510288 #### Overall Officials **Official 1:** **Affiliation:** Department of Biliary and Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University **Name:** Zhang Rui, PhD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001661 - Term: Biliary Tract Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001660 - Term: Biliary Tract Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000005705 - Term: Gallbladder Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M8824 - Name: Gallbladder Neoplasms - Relevance: HIGH - As Found: Gallbladder Cancer - ID: M4947 - Name: Biliary Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M4946 - Name: Biliary Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8823 - Name: Gallbladder Diseases - Relevance: LOW - As Found: Unknown - ID: T2425 - Name: Gallbladder Cancer - Relevance: HIGH - As Found: Gallbladder Cancer ### Condition Browse Module - Meshes - ID: D000005706 - Term: Gallbladder Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M2985 - Name: Gemcitabine - Relevance: LOW - As Found: Unknown - ID: M1674 - Name: Oxaliplatin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423157 **Brief Title:** Plyometric and Stability Exercise Protocol in Female Basketball Players **Official Title:** Efficacy of a Plyometric and Stability Exercise Protocol in Female Basketball Players. A Controlled Clinical Study. #### Organization Study ID Info **ID:** PlyoBask #### Organization **Class:** OTHER **Full Name:** Universidad Católica San Antonio de Murcia ### Status Module #### Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-06-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-19 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universidad Católica San Antonio de Murcia #### Responsible Party **Investigator Affiliation:** Universidad Católica San Antonio de Murcia **Investigator Full Name:** Rubén Cuesta-Barriuso, PhD **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Introduction. Basketball is a high intensity intermittent sport, requiring jumping, running, accelerations and decelerations with changes of direction and lateral movements. Plyometric exercises are a training technique that consists of a cycle of muscle stretching and shortening in which the energy stored in the eccentric phase (lengthening) is released facilitating the production of maximum power in the concentric phase (shortening). Objective. To analyse the efficacy of a physiotherapy intervention through a protocol of plyometric and stability exercises in the improvement of vertical jump, stability, flexibility and agility in federated female basketball players. The primary variable will be the vertical jump (My jump 2.0). Secondary variables will be stability (Y balance test), flexibility (Sit and Reach) and agility (T-Test). Methods. Controlled, single-blind clinical study. 20 athletes will be randomised to the experimental and control groups. The intervention of the experimental group will consist of a protocol using plyometric and stability exercises. The athletes included in the control group will not perform any intervention and will continue with their usual routine. The intervention period will last 6 weeks, with a periodicity of 2 weekly sessions of 20 minutes each. ### Conditions Module **Conditions:** - Sports Physical Therapy **Keywords:** - Basketball - Plyometric Exercises - Stability - Flexibility - Agility - Physiotherapy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Masking Description:** Three assessments will be made throughout the study: before the intervention (T0), after the experimental phase (T1) and after a 6-week follow-up period (T2). All variables will be assessed by an evaluator blinded to the assignment of the athletes to the study groups. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The intervention period will last 6 weeks, with a periodicity of 2 weekly sessions of 20 minutes each. All interventions will take place at the Palacio de los Deportes de Murcia. All interventions will be carried out by the same physiotherapist, following the same protocol. The intervention of the experimental group will consist of a protocol using plyometric and stability exercises. **Intervention Names:** - Other: Intervention **Label:** Experimental group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The athletes included in the control group will not undergo any intervention and will continue with their usual routine. **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental group **Description:** The intervention period will last 6 weeks, with a periodicity of 2 weekly sessions of 20 minutes each. All interventions will take place at the Palacio de los Deportes de Murcia. All interventions will be carried out by the same physiotherapist, following the same protocol. The intervention of the experimental group will consist of a protocol using plyometric and stability exercises. **Name:** Intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The vertical jump will be measured with the My jump 2.0® application. The athlete will be asked to jump as high as possible from a standing position, raising the body in the air by means of an impulse generated by the leg muscles. The evaluation consists of the recording of the jump, the calculation of the height of the vertical jump and the athlete's strength and speed levels. The unit of measurement of this tool is the centimetre, where the greater the distance, the higher the vertical jump. **Measure:** Assess the changes in vertical jump **Time Frame:** Screening visit, within the first seven days after treatment and after six weeks follow-up #### Secondary Outcomes **Description:** Stability is measured using the Y balance test. Three strips of adhesive tape are placed on the floor in a Y shape. The athlete, placed in the centre of the Y, will maintain unipodal balance while with the contralateral leg trying to reach the farthest point in each direction (anterior, posteromedial and posterolateral), without lifting the heel of the supporting foot which is the one being evaluated. Three attempts shall be made with each leg. The distance is measured with a tape measure, in centimetres (19), where the greater the distance, the greater the stability. **Measure:** Assess the changes in stability **Time Frame:** Screening visit, within the first seven days after treatment and after six weeks follow-up **Description:** Flexibility will be assessed with the Sit and Reach test. The athlete will sit on the floor, with her knees straight and her feet placed against the edge of a box. From this position, the participant shall progressively perform a trunk flexion, trying to reach as far as possible with the tips of her hands on the scale graduated in centimetres on the box. The unit of measurement for this test is the centimetre, where the greater the distance reached, the greater the flexibility. **Measure:** Assess the changes in flexibility **Time Frame:** Screening visit, within the first seven days after treatment and after six weeks follow-up **Description:** Agility will be assessed with the T-Test. Four cones should be placed in a T-shape: A at the starting point; B at 9.14 m forward; and C and D at the sides of this at 4.57 m the other two cones. The athlete must go as fast as possible to cone B and touch it with the tip with her right hand, then she must go to the sides touching cones C and D with the hand of the same side, return to touch cone B with the left hand and lastly, move backwards and go over cone A. The unit of measurement is the second, where lower times indicate efficient agility. **Measure:** Assess the changes in agility **Time Frame:** Screening visit, within the first seven days after treatment and after six weeks follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Female players over 18 years of age. * That during the study period they play basketball competing in the 1st Women's Division 1 category of the Basketball Federation of the Region of Murcia. * That they perform strength exercises at least once a week. * That they sign the informed consent document. Exclusion Criteria: * Players with knee or ankle injuries in the 6 months prior to the study. * Players who use ankle or knee braces regularly. * Players with lower limb surgery in the last year. * Players whose participation is contraindicated by the team doctor, physiotherapist or physical trainer. **Healthy Volunteers:** True **Maximum Age:** 30 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Rubén Cuesta-Barriuso, PhD **Phone:** 607547274 **Role:** CONTACT #### Locations **Location 1:** **City:** Murcia **Country:** Spain **Facility:** Universidad Católica San Antonio, Murcia **Zip:** 30107 ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423144 **Brief Title:** PD-1/PD-L1 Inhibitors and Anti-angiogenic Therapy Combined With/Without TACE/HAIC in Patients With BCLC B/C Hepatocellular Carcinoma Beyond Up-to-7 **Official Title:** A Retrospective Study Comparing Interventional Therapy (TACE/HAIC) Combined With PD-1/PD-L1 Inhibitors and Anti-angiogenic Agents Versus PD-1/PD-L1 Inhibitors and Anti-angiogenic Agents Alone in the First-line Treatment of Intermediate and Advanced Hepatocellular Carcinoma Beyond up to Seven #### Organization Study ID Info **ID:** ZL-2024-06 #### Organization **Class:** OTHER **Full Name:** Shanghai Zhongshan Hospital ### Status Module #### Completion Date **Date:** 2024-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Shanghai Zhongshan Hospital #### Responsible Party **Investigator Affiliation:** Shanghai Zhongshan Hospital **Investigator Full Name:** Lan Zhang **Investigator Title:** Chief physician **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is a retrospective study that retrospectively included patients with intermediate and advanced HCC beyond up to seven who received first-line treatment with PD-1/PD-L1 inhibitors and anti-angiogenic agents combined with/without TACE/HAIC from January 01, 2019 to December 31, 2023 in the Department of Hepatic Oncology and Department of Liver Cancer Surgery, Zhongshan Hospital, Fudan University. ### Conditions Module **Conditions:** - Hepatocellular Carcinoma ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Logical therapy combined with systemic therapy **Intervention Names:** - Procedure: TACE/HAIC - Drug: PD-1/PD-L1 inhibits and anti-angiogenic agents **Label:** Group LS #### Arm Group 2 **Description:** Systemic therapy alone（PD-1/PD-L1 inhibits and anti-angiogenic agents） **Intervention Names:** - Drug: PD-1/PD-L1 inhibits and anti-angiogenic agents **Label:** Group S ### Interventions #### Intervention 1 **Arm Group Labels:** - Group LS **Description:** TACE/HAIC were performed within 1 month prior/after the first PD-1/PD-L 1 inhibitor/antiangiogenic drug treatment; **Name:** TACE/HAIC **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Group LS - Group S **Description:** Agents were administrated based on the instructions recommended **Name:** PD-1/PD-L1 inhibits and anti-angiogenic agents **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The time from the beginning of treatment to the time of tumor progression or death from any cause (according to mRECIST and RECIST v1.1) **Measure:** PFS **Time Frame:** Up to 48 months **Description:** The percentage of patients who have best overall response of complete response (CR) or partial response (PR) according to mRECIST and RECIST v1.1 **Measure:** ORR **Time Frame:** Up to 48 months #### Secondary Outcomes **Description:** OS was defined as the interval from the date of the initial administration of any drug/procedure to death from any cause. **Measure:** OS **Time Frame:** Up to 48 months **Description:** Safety was defined the incidence and severity of adverse events (AEs) and serious adverse events (SAEs). The severity of AEs were evaluated based on the National Cancer Institute Common Terminology Criteria for Adverse Events version (NCI-CTCAE) v5.0. **Measure:** Safety **Time Frame:** Up to 48 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients who have been diagnosed with advanced hepatocarcinoma (HCC), confirmed histologically or clinically. * Patients with Barcelona (BCLC) stage B and C beyond up to seven; * Have not received any prior systemic therapy for HCC (including: chemotherapy, molecular targeted therapy, immunotherapy); * Receiving only post-marketing PD-1/PD-L1 inhibitors in combination with anti-angiogenic agents (including, but not limited to, drugs containing hepatocellular carcinoma indications); \*The interval between the first use of PD-1/PD-L 1 inhibitors and the use of anti-angiogenic drugs is ≤ 1 week * TACE was performed within 1 month prior/after the first PD-1/PD-L 1 inhibitor/antiangiogenic drug treatment; * TACE treatment followed by at least 1 cycle of combination therapy, including: cTACE and DEB-TACE; * There is at least 1 measurable lesion in the liver according to RECIST v1.1 criteria Exclusion Criteria: * Cholangiocellular carcinoma, mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or hepatic fibrous laminar carcinoma that has been pathologically/histologically confirmed; * Patients who do not meet the above definition of combination therapy; * Patients had malignant tumors other than HCC within 5 years prior to enrollment (except cured limited tumors, including cervical carcinoma in situ, basal cell carcinoma of the skin, and prostate carcinoma in situ) **Maximum Age:** 100 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with intermediate and advanced hepatocellular carcinoma beyond up to seven ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Lan Zhang, MD, Ph.D **Phone:** 13918876432 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000000230 - Term: Adenocarcinoma - ID: D000008113 - Term: Liver Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000004066 - Term: Digestive System Diseases - ID: D000008107 - Term: Liver Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M9613 - Name: Carcinoma, Hepatocellular - Relevance: HIGH - As Found: Hepatocellular Carcinoma - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M11113 - Name: Liver Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000006528 - Term: Carcinoma, Hepatocellular ### Intervention Browse Module - Ancestors - ID: D000043924 - Term: Angiogenesis Modulating Agents - ID: D000006133 - Term: Growth Substances - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000006131 - Term: Growth Inhibitors - 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: M22318 - Name: Angiogenesis Inhibitors - Relevance: HIGH - As Found: Approved protocol - ID: M5982 - Name: Chlorotrianisene - Relevance: LOW - As Found: Unknown - ID: M9231 - Name: Growth Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000020533 - Term: Angiogenesis Inhibitors ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423131 **Brief Title:** Prospective Clinical Trial for Children With TCRαβ Depleted vs Traditional Haplo Identicle HSCT **Official Title:** TCRαβ+ Cell Deleted Versus Traditional Haploidentical Hematopoietic Stem Cell Transplantation ：A Single-center, Prospective, Non-randomized Controlled Clinical Study #### Organization Study ID Info **ID:** SCMCIRB-K2024030-2 #### Organization **Class:** OTHER **Full Name:** Shanghai Jiao Tong University School of Medicine ### Status Module #### Completion Date **Date:** 2028-03-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-26 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-03-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-26 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Sijia Gu #### Responsible Party **Investigator Affiliation:** Shanghai Jiao Tong University School of Medicine **Investigator Full Name:** Sijia Gu **Investigator Title:** Principal investigator **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a single-center prospective, non-randomized controlled clinical study in China using CliniMACS TCRα/β+ cell depleted stem cell haploidentical donors versus conventional Beijing protocol for haploidentical hematopoietic stem cell transplantation in children. **Detailed Description:** 1:1 non-randomized controlled clinical study in single center using CliniMACS TCRα/β+ cell depleted stem cell versus conventional Beijing protocol for haploidentical hematopoietic stem cell transplant. The purpose of this study is to obtain 30% decrease grade II-IV aGVHD and better qulity of life for TCRα/β+ cell depleted haploidentical stem cell transplantaion. ### Conditions Module **Conditions:** - Graft-Versus-Host Disease - Hematopoietic Stem Cell Transplantation - Child, Only - Haploidentical Hematopoietic Stem Cell Transplantation ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** TCRαβ depleted HSCT compare to traditional Beijing haploidentical HSCT ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 110 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Beijing haploidenticla HCT is the routinely traditional way used for haploidentical HCT **Label:** Traditional Haplo identicle HCT **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** TCRαβ Depleted haploidentical HCT is experimental used to decrease GVHD and obtain better qulity of life for children with haploidentical HCT. **Intervention Names:** - Procedure: TCRαβ Depleted haploidentical HCT **Label:** TCRαβ Depleted haploidentical HCT **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - TCRαβ Depleted haploidentical HCT **Description:** Use the CliniMACS TCRα/β deplete from the mobilized peripheral blood stem cells of haploidentical donor in children **Name:** TCRαβ Depleted haploidentical HCT **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Incidence of grade II-IV acute graft-versus-host disease (GVHD) until Day 100 post-transplantation. **Measure:** Incidence of grade II-IV acute GVHD **Time Frame:** day+100 **Description:** compare the incidence of TRM until Day 100 post-transplantation **Measure:** incidence of treatment related mortality(TRM) **Time Frame:** day +100 #### Secondary Outcomes **Description:** compare the incidence of GRFS and OS post HSCT 1y and 2y **Measure:** post HSCT day 1y and 2y GRFS and OS **Time Frame:** day +1y and +2y **Description:** compare the incidence of cGVHD post HSCT 1y and 2y **Measure:** cGVHD post day 1y and 2y **Time Frame:** day +1y and +2y **Description:** compre the incidence of TRM post HSCT day 1y and 2y **Measure:** TRM post day +1y and +2y **Time Frame:** day +1y and +2y ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 8 weeks to 18 years * Children who meet the indicators haploidentical hematopoietic cell transplantation * No HLA ≥ 9/10 donor or not suitable for this type of donor due to illness * Informed consent must be signed (by the patient or legal representative) Exclusion Criteria: * Liver function abnormalities with bilirubin \>2 mg/dL and elevation of transaminases higher than 400 U/L * Chronic active viral hepatitis * Ejection fraction \<50% * Respiratory failure necessitating supplemental oxygen * Patients with a history of psychiatric illness or a condition which could interfere with their ability to understand the requirements of the study * Patients unwilling or unable to comply with the protocol or unable to give informed consent * Concurrent severe or uncontrolled infection **Maximum Age:** 18 Years **Minimum Age:** 8 Weeks **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jing Chen, PhD **Phone:** 38626161 **Phone Ext:** 82073 **Role:** CONTACT #### Locations **Location 1:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** J Chen, PhD - **Phone:** 38626161 - **Phone Ext:** 82073 - **Role:** CONTACT **Country:** China **Facility:** Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University **State:** Shanghai **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Shanghai Children's Medical Center **Name:** Jing Chen, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9189 - Name: Graft vs Host Disease - Relevance: HIGH - As Found: Graft Versus Host Disease - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T2832 - Name: Homologous Wasting Disease - Relevance: HIGH - As Found: Graft Versus Host Disease ### Condition Browse Module - Meshes - ID: D000006086 - Term: Graft vs Host Disease ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423118 **Brief Title:** Sleep Apnea and Cognition in Older Adults **Official Title:** Cross-sectional Investigation of Sleep Apnea and Cognition in Older Adults Using the ANNE Vital Sign System #### Organization Study ID Info **ID:** 5140 #### Organization **Class:** OTHER **Full Name:** Sunnybrook Health Sciences Centre ### Status Module #### Completion Date **Date:** 2034-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2034-04 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-09 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Alzheimer Society of Canada #### Lead Sponsor **Class:** OTHER **Name:** Sunnybrook Health Sciences Centre #### Responsible Party **Investigator Affiliation:** Sunnybrook Health Sciences Centre **Investigator Full Name:** Dr. Jennifer Rabin **Investigator Title:** Scientist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this cross-sectional, observational, medical device trial is to examine the association of several sleep parameters, including specific respiratory events and an apnea-hypopnea index, with cognitive performance in older adults. The main question the study aims to answer is: Is there an association between sleep parameters with cognitive performance? Researchers will collect sleep parameters from participants using a device called the ANNE Vital Sign System and will test whether they are associated with performance on different memory and thinking tasks. Participants will: Complete a battery of cognitive tests to assess their memory and thinking performance. Wear the ANNE Vital Sign System continuously for a period of 24 hours. **Detailed Description:** Nearly a third of older adults experience difficulty initiating or maintaining sleep and nearly half have sleep apnea. However, current reliance on gold-standard in-lab polysomnography has been a barrier to detecting, quantifying, and measuring these sleep problems. Polysomnography is difficult for many older adults to tolerate, requires specialized technologists to obtain and analyze the recordings, is labour intensive and expensive, and not widely available in many jurisdictions, all of which impede use by primary care clinicians or end-users. Recent advances in wearable sensor development have led to a new generation of wearable sensors that have good potential to overcome these barriers. Accumulating evidence suggests that poor sleep quality increases the risk of cognitive impairment and dementia, however studies in older adults linking objectively measured sleep function with comprehensive cognitive testing are lacking. The primary objective of this cross-sectional study is to examine the association of several objectively measured sleep parameters (e.g., sleep apnea) with cognitive performance. The Advanced NeoNatal Epidermal (ANNE) Vital Sign System was created for the purposes of providing real-time vital signs monitoring in the paediatric intensive care unit. The ANNE Vital Sign System integrates simultaneous synchronized ambulatory measurement of electrocardiography, photoplethysmography with derived pulse oximetry, pulse arrival time with derived beat-to-beat blood pressure, triaxial accelerometry, respiratory rate, and temperature, to enable accurate measurement of sleep apnea. The characteristics that make the ANNE Vital Sign System ideal for use in children (non-invasive, flexible, ease of use, comfort, skin safety) also make it ideal for use in adults. Compelling in-laboratory preliminary data from our collaborator at Sunnybrook Research Institute (SRI) has demonstrated the capacity for ANNE to detect and characterize sleep apnea in older adults. After the informed consent process, participants will complete a 1-hour battery of cognitive tests. If participants have completed the same set of cognitive tests in the past year at SRI no cognitive testing will take place. Following testing, participants will be shown how to affix and remove the sensors to their chest and dominant index finger (or non-dominant if dominant is not available) according to manufacturer recommendations. Participants will be given the device to take home and asked to wear the sensors for a 24-hour period. They will also be provided with ANNE chest adhesive, ANNE limb adhesive, and a clinical waterproof 3M Tegaderm dressing. Participation in the study concludes after the device is worn for the 24-hour period. Though there are no substantial benefits for participants, this study may lead to a better understanding of the association between sleep apnea and cognition in older adults. Given that poor sleep quality is a risk factor for dementia, there is a need to better characterize the relationship between objective sleep parameters and cognition. ### Conditions Module **Conditions:** - Sleep - Cognition - Aging **Keywords:** - sleep - cognition - aging ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** * Age 55-85 * 8+ years of education * No frank cognitive impairment or dementia **Intervention Names:** - Device: ANNE Vital Sign System **Label:** Healthy Older Adults ### Interventions #### Intervention 1 **Arm Group Labels:** - Healthy Older Adults **Description:** The ANNE Vital Sign System is a pair of non-invasive, flexible sensors originally designed for vital signs monitoring in the paediatric intensive care unit. **Name:** ANNE Vital Sign System **Other Names:** - ANNE One **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** An apnea-hypopnea index, the combined average number of apneas and hypopneas that occur per hour of sleep, will be calculated from ANNE Vital Sign System data. Study staff will annotate apneas and hypopneas to calculate the index using an EEG annotation tool. A linear regression model will be constructed to examine the association between apnea-hypopnea index and performance on a battery of neuropsychological tests, which includes: 1. Montreal Cognitive Assessment 2. Free and Cued Selective Reminding Test 3. Benson Complex Figure Copy 4. Doors Test, Parts A and B 5. WAIS-III Symbol Digit Coding 6. Benson Complex Figure Delay 7. Benson Complex Figure Recognition 8. 7-24 Spatial Recall Test 9. Colour Trails Test, parts 1 and 2 10. Controlled Oral Word Association Test (FAS) 11. Semantic Fluency (Animals) 12. Trail Making Test, parts A and B **Measure:** Association between apnea-hypopnea index and cognitive performance **Time Frame:** 24 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Sufficient knowledge of English to understand and provide informed consent 2. Competent to provide consent 3. Aged 55-85, Male and Female 4. ≥ 8 years of education 5. Capable of cooperating for the duration of the study procedures and assessments 6. No frank cognitive impairment or dementia 7. Sufficient (corrected) vision to participate in cognitive testing 8. Sufficient (corrected) hearing to participate in cognitive testing Exclusion Criteria: 1. Cannot read and comprehend English language instructions 2. Major cardio- or cerebro-vascular event (heart attack, stroke, significant white matter changes) 3. Unstable diseases (e.g., pulmonary, endocrine disorder) 4. Active malignancy or infectious diseases 5. History of significant learning disability 6. Major psychiatric/neurologic/degenerative disorder, including a diagnosis of mild cognitive impairment or dementia 7. History of significant head trauma or recurrent concussions requiring hospitalization followed by persistent neurologic defaults or known structural brain abnormalities 8. Pain or sleep disorder that could interfere with cognitive testing 9. Major medical concerns that might interfere with cognitive testing 10. Recent history of substance/drug abuse 11. Known nickel allergy 12. Known cardiac implantable device 13. Known arrhythmias 14. Outside the included age range 15. Pregnant or breast feeding 16. Otherwise unable to use the ANNE sensors; for example, finger amputations. **Healthy Volunteers:** True **Maximum Age:** 85 Years **Minimum Age:** 55 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Healthy older adults between the ages of 55-85, with 8+ years of education and no frank cognitive impairment or dementia. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Alexander Nyman, BSc **Phone:** 416-480-6100 **Role:** CONTACT #### Locations **Location 1:** **City:** Toronto **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Silina Boshmaf, BSc - **Phone:** 416-480-6100 - **Role:** CONTACT ***Contact 2:*** - **Name:** Jennifer Rabin, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Canada **Facility:** Sunnybrook Health Sciences Centre **State:** Ontario **Status:** RECRUITING **Zip:** M6G3T6 #### Overall Officials **Official 1:** **Affiliation:** Sunnybrook Research Institute **Name:** Jennifer Rabin, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Foley DJ, Monjan AA, Brown SL, Simonsick EM, Wallace RB, Blazer DG. Sleep complaints among elderly persons: an epidemiologic study of three communities. Sleep. 1995 Jul;18(6):425-32. doi: 10.1093/sleep/18.6.425. **PMID:** 7481413 **Citation:** Senaratna CV, Perret JL, Lodge CJ, Lowe AJ, Campbell BE, Matheson MC, Hamilton GS, Dharmage SC. Prevalence of obstructive sleep apnea in the general population: A systematic review. Sleep Med Rev. 2017 Aug;34:70-81. doi: 10.1016/j.smrv.2016.07.002. Epub 2016 Jul 18. **PMID:** 27568340 **Citation:** Oosterman JM, van Someren EJ, Vogels RL, Van Harten B, Scherder EJ. Fragmentation of the rest-activity rhythm correlates with age-related cognitive deficits. J Sleep Res. 2009 Mar;18(1):129-35. doi: 10.1111/j.1365-2869.2008.00704.x. **PMID:** 19250179 **Citation:** Shi L, Chen SJ, Ma MY, Bao YP, Han Y, Wang YM, Shi J, Vitiello MV, Lu L. Sleep disturbances increase the risk of dementia: A systematic review and meta-analysis. Sleep Med Rev. 2018 Aug;40:4-16. doi: 10.1016/j.smrv.2017.06.010. Epub 2017 Jul 6. **PMID:** 28890168 **Citation:** Sindi S, Kareholt I, Johansson L, Skoog J, Sjoberg L, Wang HX, Johansson B, Fratiglioni L, Soininen H, Solomon A, Skoog I, Kivipelto M. Sleep disturbances and dementia risk: A multicenter study. Alzheimers Dement. 2018 Oct;14(10):1235-1242. doi: 10.1016/j.jalz.2018.05.012. Epub 2018 Jul 17. **PMID:** 30030112 **Citation:** Zhu X, Zhao Y. Sleep-disordered breathing and the risk of cognitive decline: a meta-analysis of 19,940 participants. Sleep Breath. 2018 Mar;22(1):165-173. doi: 10.1007/s11325-017-1562-x. Epub 2017 Sep 13. **PMID:** 28905231 **Citation:** Chung HU, Kim BH, Lee JY, Lee J, Xie Z, Ibler EM, Lee K, Banks A, Jeong JY, Kim J, Ogle C, Grande D, Yu Y, Jang H, Assem P, Ryu D, Kwak JW, Namkoong M, Park JB, Lee Y, Kim DH, Ryu A, Jeong J, You K, Ji B, Liu Z, Huo Q, Feng X, Deng Y, Xu Y, Jang KI, Kim J, Zhang Y, Ghaffari R, Rand CM, Schau M, Hamvas A, Weese-Mayer DE, Huang Y, Lee SM, Lee CH, Shanbhag NR, Paller AS, Xu S, Rogers JA. Binodal, wireless epidermal electronic systems with in-sensor analytics for neonatal intensive care. Science. 2019 Mar 1;363(6430):eaau0780. doi: 10.1126/science.aau0780. **PMID:** 30819934 ## Document Section ### Large Document Module #### Large Docs - Date: 2023-03-17 - Filename: ICF_000.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 483122 - Type Abbrev: ICF - Upload Date: 2024-04-24T15:01 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001049 - Term: Apnea - ID: D000012120 - Term: Respiration Disorders - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000020919 - Term: Sleep Disorders, Intrinsic - ID: D000020920 - Term: Dyssomnias - ID: D000012893 - Term: Sleep Wake Disorders - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15694 - Name: Sleep Apnea Syndromes - Relevance: HIGH - As Found: Sleep Apnea - ID: M4361 - Name: Apnea - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M22242 - Name: Parasomnias - Relevance: LOW - As Found: Unknown - ID: M22654 - Name: Sleep Disorders, Intrinsic - Relevance: LOW - As Found: Unknown - ID: M22655 - Name: Dyssomnias - Relevance: LOW - As Found: Unknown - ID: M15696 - Name: Sleep Wake Disorders - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012891 - Term: Sleep Apnea Syndromes ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423105 **Brief Title:** Influencing Factors and Prediction Model of False-negative Central Lymph Nodes in Thyroid Cancer Patients **Official Title:** Influencing Factors and Prediction Model of False-negative Central Lymph Nodes in Thyroid Cancer Patients: a Cohort Study #### Organization Study ID Info **ID:** NO.SWYX2024-225 #### Organization **Class:** OTHER_GOV **Full Name:** Shandong Provincial Hospital ### Status Module #### Completion Date **Date:** 2024-04-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-12-31 **Type:** ACTUAL #### Start Date **Date:** 2013-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Shandong University #### Lead Sponsor **Class:** OTHER_GOV **Name:** Ningning Ren #### Responsible Party **Investigator Affiliation:** Shandong Provincial Hospital **Investigator Full Name:** Ningning Ren **Investigator Title:** Principal Investigator **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The problem of false-negative lymph nodes in the central region (CLN) refers to the inability to detect lymph nodes (LN) metastasis during preoperative ultrasound examination but is confirmed by surgical and postoperative pathological examination. According to this study, the false-negative rate of CLN of patients with TC was relatively high at approximately 71.7%. The high proportion of false-negatives indicates limitations in the sensitivity of ultrasound examination, especially for detecting small LN or small metastases. The presence of false-negative CLN directly affects clinical practice. First, it may lead to insufficient selection of treatment strategies for patients with TC, thereby affecting their prognosis. Second, such false-negative results may lead surgeons to overly trust ultrasound examination during preoperative evaluation, neglecting the importance of comprehensive clinical information, and thus affecting the formulation of treatment plans. This study aimed to explore the factors influencing false-negative CLN through a cohort study and to establish a predictive model. **Detailed Description:** Setting and Population This study collected 6369 patients admitted to the Breast and Thyroid Surgery Department of Shandong Provincial Hospital between January 2013 and December 2023, who were diagnosed with TC through postoperative pathology. (SDC, Figure 1) All patients included in the study signed a written informed consent form before surgery. Ethical approval for this study (NO.SWYX2024-225) was provided by the Ethical Committee of Shandong Provincial Hospital, Jinan, China on 15 April 2024. According to the relevant literature, the criteria for identifying abnormal cervical LN under ultrasound are: disappearance of the LN hilum structure or abnormalities in the skin and medulla, LN becoming round or having an increased aspect ratio, microcalcifications in the LN, cystic changes present in LN, and abnormal blood flow signals in LN.17 The inclusion and exclusion criteria are: all cases are newly diagnosed TC cases; all cases underwent preoperative thyroid and neck LN examinations by the Ultrasound Department of Shandong Provincial Hospital; all cases underwent thyroid surgery for the first time; all cases were diagnosed with TC through postoperative pathological examination; excluding cases of other combined tumors or major diseases. This study used the postoperative paraffin pathology results as the gold standard for diagnostic testing. All ultrasound examinations were performed by two ultrasound physicians. When two ultrasound physicians had different opinions, a third senior ultrasound physician was requested to assist in the evaluation. Data Collection After obtaining written consent, we recorded the patient\&#39;s relevant information in detail and followed up on the patient\&#39;s postoperative paraffin pathology results. The collected and organized items included: 1) sex, age, and past medical history; 2) preoperative ultrasound information; 3) preoperative fine-needle biopsy information; 4) surgical information; 5) postoperative pathological information; and 6) immunohistochemical information. Statistical Analysis This study first analyzed the baseline data of the included patients and obtained descriptive data on the current status of patients with TC. (Table 1) This study also analyzed the efficacy of ultrasound and fine-needle aspiration (FNA) for the evaluation of cervical LN. (Table 2) Subsequently, analysis was conducted on 52 factors that may cause false-negative CLN of TC. (Table 3) A total of 16 statistically significant influencing factors were identified. (Table 4) To construct a predictive model for the occurrence of false-negative CLN of the thyroid gland, we selected five preoperative influencing factors with predictive significance from eight preoperative influencing factors and drew a forest chart for data visualization and outcome prediction. This study was analyzed using IBM SPSS 29.0 software. Quantitative data are represented by mean ± standard deviation when it follows a normal distribution and homogeneity of variance, and an independent sample t-test is used for comparison between the two groups; the median (P25, P75) is used to represent non-normal distributions, and a non-parametric Mann-Whitney test is used for comparison between the two groups. Qualitative data were expressed as percentages (%), and intergroup comparisons were conducted using the chi-square or Fisher\&#39;s exact test. Variables with statistical significance in the univariate analysis and those professionally considered to have an impact on the outcome were included in the logistic regression model to explore the independent factors influencing the outcome. The test level P was set at 0.05. A forest map was drawn using Graphpad Prism 10.12 software, and a column chart and credibility analysis were drawn using R Studio 4.3 software. ### Conditions Module **Conditions:** - Thyroid Cancer **Keywords:** - thyroid cancer - central lymph nodes - false negative ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 6369 **Type:** ACTUAL **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 5 Years ### Arms Interventions Module #### Arm Group 1 **Description:** This article defines cases that preoperative ultrasound indicates no suspicious malignant enlargement of central lymph nodes and postoperative paraffin pathology indicates the presence of metastatic cancer in central lymph nodes as false-negative cases. **Label:** false negative ### Outcomes Module #### Primary Outcomes **Description:** This article defines cases that preoperative ultrasound indicates no suspicious malignant enlargement of central lymph nodes and postoperative paraffin pathology indicates the presence of metastatic cancer in central lymph nodes as false-negative cases. **Measure:** Pathological results **Time Frame:** From enrollment to the end of treatment at 5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. All cases are new cases of thyroid cancer. 2. All clinical data and research materials of the cases are complete. 3. All cases underwent preoperative thyroid and neck lymph node examinations by the Ultrasound Department of Shandong Provincial Hospital. 4. All cases showed no swelling in the central lymph node status on preoperative ultrasound. 5. All cases underwent initial surgical treatment. 6. All cases were diagnosed with thyroid cancer through postoperative pathological examination. Exclusion Criteria: 1. Except for cases of recurrence. 2. Cases with incomplete clinical data and research materials are excluded. 3. Cases that have not undergone thyroid and neck lymph node examination by the ultrasound department of Shandong Provincial Hospital before surgery are excluded. 4. Cases with enlarged lymph nodes in the central thyroid region indicated by preoperative ultrasound are excluded. 5. Excluding cases of secondary surgery. 6. Cases with postoperative pathological diagnosis of benign thyroid tumors are excluded. **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** This study collected 6369 patients admitted to the Breast and Thyroid Surgery Department of Shandong Provincial Hospital between January 2013 and December 2023, who were diagnosed with TC through postoperative pathology. ### IPD Sharing Statement Module **Description:** for privacy **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004700 - Term: Endocrine System Diseases - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000006258 - Term: Head and Neck Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M16723 - Name: Thyroid Neoplasms - Relevance: HIGH - As Found: Thyroid Cancer - ID: M16718 - Name: Thyroid Diseases - Relevance: HIGH - As Found: Thyroid - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013964 - Term: Thyroid Neoplasms - ID: D000013959 - Term: Thyroid Diseases ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423092 **Brief Title:** Music Therapy Songwriting and Mental Health in Neonatel Intensive Care Unit (NICU) Parents **Official Title:** Short-term Effectiveness of Music Therapy Songwriting on Mental Health Outcomes of At-risk Parents in the Neonatal Intensive Care Unit: an International Multicenter Mixed-methods Study. #### Organization Study ID Info **ID:** 166-23 UNV #### Organization **Class:** OTHER **Full Name:** Sanitas University ### Status Module #### Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Sanitas University #### Lead Sponsor **Class:** OTHER **Name:** Claudia Aristizábal #### Responsible Party **Investigator Affiliation:** Sanitas University **Investigator Full Name:** Claudia Aristizábal **Investigator Title:** Director **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The mental health of parents of preterm newborns (PTNB) is negatively affected by prolonged hospitalization of the PTNB in the intensive care unit. This produces changes in the role of the parents and the bond with the newborn, leading to states of depression, anxiety, and stress. Several strategies, including music therapy, have been implemented to mitigate the negative impact on the parents' mental health. The main objectives of the proposed trial are to determine whether Music Therapy (MT) songwriting combined with standard care (SC) during NICU stay is superior to SC alone in reducing the risk of postpartum depression in at-risk parents of preterm children at the end of treatment, and understand the lived experiences of participating parents who received music therapy for their mental health. **Detailed Description:** This study employs a multicenter, mixed-method approach, with a quantitative component that will be a pragmatic parallel controlled randomized clinical trial (RCT) and a qualitative component that will include phenomenological study. The quantitative component will assess depression and anxiety, which will be evaluated with the Edinburgh Postnatal Depression Scale (EPDS) and the Generalized Anxiety Disorder Scale (GAD-7), respectively. Secondary outcomes will be resilience, coping, stress, and mental well-being. These outcomes will be measured in the first week of hospitalization (baseline measure) and then in weeks 1, 2, and 3 of the intervention. Changes in scores will be assessed to identify the effect, and mediating variables will be determined by multivariate analysis. Semi-structured interviews will be conducted on the parents' experience of music therapy songwriting for the baby. The study will provide data on the effect of music therapy songwriting on the mental health of parents of neonates with brain injuries (PTNB) versus standard care and will document the lived experience of music therapy songs. The results may inform the standardization of this strategy in neonatal intensive care units (NICUs) to support and accompany parents and decrease the impact on their mental health. ### Conditions Module **Conditions:** - Mental Health Impairment ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 102 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The music therapy songwriting is a method frequently employed in music therapy sessions. This method involves the collaborative creation of lyrics and/or music with the participants. The intervention will consist of nine sessions, each of which will last approximately 30 to 45 minutes. Three sessions will be conducted per week until a minimum of six and a maximum of nine sessions are achieved. **Intervention Names:** - Other: Music therapy songwriting **Label:** Music therapy songwriting + standard care **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Standard care is the usual care provided to parents of newborns hospitalized in a neonatal intensive care unit (NICU). This care includes providing information about the baby's health status and recommendations during contact with the baby. Additionally, when a health professional identifies symptoms of mental health disturbance in the parents, they are referred to a mental health professional for appropriate management. **Label:** Standard care **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Music therapy songwriting + standard care **Description:** Session 1: The goal of the first music therapy session is to know the parents musically and to provide information about song creation. This is achieved by exploring their favorite songs. Options for creating a song (original song or song parody) are presented and possibilities for creating lyrics are discussed. Sessions 2-7: The structure of the song will be created and discussed with the parents. Parents will also be invited to include written messages from other family members in the lyrics if they wish. In each session, the developing welcome song is sung together with the parents, accompanied by the music therapist, who provides vocal or instrumental support. The final sessions (Sessions 8-9) are dedicated to singing the final version of the song with the parents and their infant. Should the parents desire, a final recording of the song will also be made and the digital songbook will be created. **Name:** Music therapy songwriting **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Postpartum depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS). **Measure:** Postpartum depression **Time Frame:** It will be measured during the first week of hospitalization (baseline measurement) and at weeks 1, 2, and 3 of the intervention. #### Secondary Outcomes **Description:** Anxiety will be assessed with the Generalized Anxiety Disorder Scale (GAD-7). **Measure:** Anxiety **Time Frame:** It will be measured during the first week of hospitalization (baseline measurement) and at weeks 2 and 3 of the intervention. **Description:** The Warwick Edinburgh Mental Well-Being Scale (WEMWBS) will be employed to assess well-being. **Measure:** Well-being **Time Frame:** It will be measured during the first week of hospitalization (baseline measurement) and at weeks 2 and 3 of the intervention. **Description:** Resilience will be assessed with the Brief Resilience Scale (BRS). **Measure:** Resilience **Time Frame:** It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention. **Description:** Stress will be assessed with the 10-item Perceived Stress Scale (PSS-10). **Measure:** Stress **Time Frame:** It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention. **Description:** Stress response will be assessed with the Brief COPE Inventory (Brief-COPE). **Measure:** Coping **Time Frame:** It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * The study population consisted of parents/caregivers of newborns hospitalized in neonatal intensive care units (NICUs) with gestational ages of ≤32 weeks and expected hospitalizations of at least three weeks. In the case of a twin pregnancy, the firstborn infant was randomly assigned to one of the intervention groups, while both infants received the same treatment according to the outcome of randomization. * Mother a total score of ≥10 and/or father a total score of ≥7 on the EPDS (Edinburgh Postnatal Depression Scale) * Mother and/or father a total score of ≥8 on the GAD-7 (Generalized Anxiety Disorder Scale) Exclusion Criteria: * Parents/caregivers with known auditory problems that prevent participation in MT. Moreover parents/caregivers with a documented mental illness or cognitive impairment that prevents them from being able to complete the study intervention or outcome assessments. * Parents/caregivers of premature infants in palliative or end-of-life care, infants with known hearing impairment, or infants in the custody of social services. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Mark Ettenberger, PhD **Phone:** +57 311 284 7635 **Role:** CONTACT #### Locations **Location 1:** **City:** Barranquilla **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Mark Ettenberger, PhD - **Phone:** +57 605 3319424 - **Role:** CONTACT **Country:** Colombia **Facility:** Clínica Iberoamérica en Colombia **State:** Atlántico **Location 2:** **City:** Bogotá **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Mark Ettenberger, PhD - **Phone:** (+57) 601 745 5100 - **Role:** CONTACT **Country:** Colombia **Facility:** Clinica Pediátrica **State:** Cundinamarca **Location 3:** **City:** Bogotá **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Mark Ettenberger - **Phone:** (+57) 6015948650 - **Role:** CONTACT ***Contact 2:*** - **Name:** Marcela Beltrán, MSc - **Role:** SUB_INVESTIGATOR ***Contact 3:*** - **Name:** Mark Ettenberger, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Angélica Hernández, MSc - **Role:** SUB_INVESTIGATOR ***Contact 5:*** - **Name:** Ana María Diaz, MSc - **Role:** SUB_INVESTIGATOR ***Contact 6:*** - **Name:** Johana Benavides, MSc - **Role:** SUB_INVESTIGATOR **Country:** Colombia **Facility:** Clínica Universitaria Colombia **State:** Cundinamarca **Location 4:** **City:** Ibagué **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Mark Ettenberger, PhD - **Phone:** +57 60 1 646 6060 - **Role:** CONTACT **Country:** Colombia **Facility:** Clínica Keralty Ibagué **State:** Tolima **Location 5:** **City:** Gdańsk **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Łucja Bieleninik, PhD - **Phone:** +48 58 523 30 00 - **Role:** CONTACT ***Contact 2:*** - **Name:** Łucja Bieleninik, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Ilona Poćwierz-Marciniak, PhD - **Role:** SUB_INVESTIGATOR **Country:** Poland **Facility:** University of Gdańsk ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423079 **Brief Title:** Scleral Fixation for Intraocular Lens-Bag Dislocation **Official Title:** Complex Intaocular Lens-Bag Fixation With Siepser's Scleral Sliding Knots #### Organization Study ID Info **ID:** Siep_001 #### Organization **Class:** OTHER **Full Name:** University of Naples ### Status Module #### Completion Date **Date:** 2022-05-10 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-05-10 **Type:** ACTUAL #### Start Date **Date:** 2017-05-10 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Naples #### Responsible Party **Investigator Affiliation:** University of Naples **Investigator Full Name:** Luca D'Andrea **Investigator Title:** Prinicipal investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Novel introflective sutures offer a minimally invasive approach for stable fixation of dislocated bag-IOL complexes, preserving visual acuity and reducing corneal complications in patients with pseudoexfoliation syndrome. **Detailed Description:** To assess the one-month outcomes of visual performance and positional stability of capsule-fixated intraocular lenses (IOLs) in patients with IOL-Bag complex dislocation. Patients with intraoperative complications or prior posterior capsule Nd-YAG laser were excluded. Surgical intervention involved creating a superior service keratotomy and using introflective sutures for IOL fixation. Best Corrected Visual acuity (BCVA), endothelial cell counts, and tonometry were assessed at multiple postoperative time points. We also evaluated the mean spherical equivalent (SE), and the residual cylinder and sphere at each follow-up. ### Conditions Module **Conditions:** - Pseudoexfoliation Syndrome ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 36 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients affected by pseudoexfoliation syndrome, with inferior dislocation of the bag-IOL complex. **Intervention Names:** - Procedure: Siepser knots **Label:** IOL-Bag Dislocation patients ### Interventions #### Intervention 1 **Arm Group Labels:** - IOL-Bag Dislocation patients **Description:** Surgical intervention involved creating a superior service keratotomy and using introflective sutures for IOL fixation **Name:** Siepser knots **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** to evaluate the best corrected visual acuity after the surgery **Measure:** Best corrected visual acuity **Time Frame:** 1 year #### Secondary Outcomes **Description:** to evaluate the Endothelial cells count after the surgery **Measure:** Endothelial cells count **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients affected by pseudoexfoliation syndrome, with inferior dislocation of the bag-IOL complex Exclusion Criteria: * patients who underwent intraoperative complications, * dislocation in the vitreous chamber of the bag-IOL complex, * patients who had already undergone posterior capsule Nd-YAG laser **Maximum Age:** 90 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** patients affected by pseudoexfoliation syndrome, with inferior dislocation of the bag-IOL complex after cataract surgery. ### Contacts Locations Module #### Locations **Location 1:** **City:** NAples **Country:** Italy **Facility:** University of Naples Federico II **Zip:** 80131 ### IPD Sharing Statement Module **Access Criteria:** available on request **Description:** all collected IPD **IPD Sharing:** YES **Time Frame:** 5 years **URL:** https://guides.lib.umich.edu/datamanagement/clinicaltrials ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007499 - Term: Iris Diseases - ID: D000014603 - Term: Uveal Diseases - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC11 - Name: Eye Diseases - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M20069 - Name: Exfoliation Syndrome - Relevance: HIGH - As Found: Pseudoexfoliation Syndrome - ID: M7385 - Name: Joint Dislocations - Relevance: LOW - As Found: Unknown - ID: M10531 - Name: Iris Diseases - Relevance: LOW - As Found: Unknown - ID: M17351 - Name: Uveal Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: T5824 - Name: Uveal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000017889 - Term: Exfoliation Syndrome ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423066 **Brief Title:** Developing a Machine Learning Model to Predict Pleural Adhesion Preoperatively Using Pleural Ultrasound **Official Title:** Developing a Machine Learning Model to Predict Pleural Adhesion Preoperatively Using Pleural Ultrasound: a Prospective Observational Study #### Organization Study ID Info **ID:** USPDPA01 #### Organization **Class:** OTHER **Full Name:** Peking Union Medical College Hospital ### Status Module #### Completion Date **Date:** 2026-03-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Peking Union Medical College Hospital #### Responsible Party **Investigator Affiliation:** Peking Union Medical College Hospital **Investigator Full Name:** Xuehan Gao **Investigator Title:** Research Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study aims to investigate the accuracy of using pleural ultrasound (USP) to identify pleural adhesions in patients who plan to receive video-assisted thoracoscopic surgery. It employs three-dimensional convolutional neural network (3D-CNN) technology to process USP-related images and video data for machine learning, and to establish a diagnostic model for identifying pleural adhesions using 3D-CNN-USP. The study will determine the sensitivity, specificity, positive predictive value, and negative predictive value of 3D-CNN-USP in identifying pleural adhesions. Additionally, it will explore the feasibility and effectiveness of using 3D-CNN-USP for preoperative identification of pleural adhesions in VATS, thereby supporting the implementation of day surgery in thoracic surgery and ultimately serving clinical practice. **Detailed Description:** Lung cancer is currently the leading cause of death from malignant tumors worldwide. Surgery is the primary treatment method for lung cancer, and breakthroughs in thoracic surgical techniques play a crucial role in the diagnosis and treatment of lung cancer. Medical ultrasound technology, due to its non-invasive, flexible, convenient, and economical characteristics, is widely used in clinical practice. With the advancement of ultrasound technology and the need to address clinical challenges, ultrasound imaging technology has seen new developments in the field of thoracoscopic surgery. In the era of minimally invasive surgery, intraoperative pleural adhesions are one of the main factors affecting the implementation of video-assisted thoracoscopic surgery (VATS). Especially under the concept of enhanced recovery after surgery (ERAS), the day surgery model for VATS has gradually taken shape. However, pleural adhesions significantly increase intraoperative trauma and prolong hospital stays. Additionally, pleural adhesions increase the risk of lung injury during VATS and, in severe cases, may hinder access to the pleural space, necessitating conversion to open thoracotomy. Pleural adhesions increase intraoperative time and morbidity in thoracic surgery due to poor visibility, bleeding, and lung and vascular injuries. The presence, location, and degree of pleural adhesions are useful for determining the initial port placement or choosing between open or VATS approaches. Therefore, accurately predicting the presence and specific location of pleural adhesions preoperatively is crucial for the development of day surgery under thoracic ERAS, ensuring the safety and efficiency of future VATS day surgeries. Previous studies have shown that chest CT is difficult to predict pleural adhesions, with a sensitivity of only 72% and a sensitivity of only 46% for determining adhesions at specific locations. In contrast, ultrasonography of the pleura (USP) can dynamically display pleural sliding and adhesions with surrounding lung tissue, and has real-time monitoring capabilities based on movement, providing unique advantages for detecting pleural adhesions. Preoperative prediction of pleural adhesions using USP has significant application value. Studies have already demonstrated the advantages of using transthoracic pleural ultrasound to identify pleural adhesions. Nicola et al. conducted 1,192 ultrasounds to predict pleural adhesions, confirming 1,124 positive cases and 68 negative cases, with a sensitivity of 80.6%, specificity of 96.1%, positive predictive value of 73.2%, and negative predictive value of 97.4%. However, there are still some issues with using USP to predict pleural adhesions. Physicians who can identify pleural adhesions need to be trained in lung ultrasound, and ultrasound examination and interpretation are skill-dependent techniques. The burden of training thoracic ultrasound physicians remains a clinical challenge. Three-dimensional convolutional neural network (3D-CNN) technology is an emerging technology in the field of artificial intelligence and machine learning. Unlike traditional convolutional neural networks (CNN), 3D-CNN can process three-dimensional data that includes a time dimension, making it suitable for analyzing the real-time dynamic image features of ultrasound images. This technology holds promise for developing a machine learning model to interpret USP images, potentially replacing physician interpretation and improving the accuracy of USP in identifying pleural adhesions. In summary, this study intends to use USP for preoperative identification of pleural adhesions in patients scheduled for VATS surgery. It aims to investigate the accuracy of USP in predicting intraoperative pleural adhesions and to develop a diagnostic model using 3D-CNN technology to process USP-related images and video data for machine learning. The study will explore the sensitivity, specificity, positive predictive value, and negative predictive value of the 3D-CNN-USP model in identifying pleural adhesions. Additionally, it will examine the feasibility and effectiveness of using 3D-CNN-USP for preoperative identification of pleural adhesions to support the implementation of day surgery in thoracic surgery. ### Conditions Module **Conditions:** - Pleural Diseases - Lung Cancer - Machine Learning **Keywords:** - pleural adhesion - 3D-CNN - machine learning - VATS ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Sensitivity of three-dimensional convolutional neural network (3D-CNN) in identifying pleural adhesions using pleural ultrasound (USP). The sensitivity value ranges from 0 to 100, with higher values indicating greater sensitivity. **Measure:** Sensitivity **Time Frame:** From enrollment to the end of surgery. #### Secondary Outcomes **Description:** Specificity off 3D-CNN in identifying pleural adhesions using USP. The specificity value ranges from 0 to 100, with higher values indicating greater specificity. **Measure:** Specificity **Time Frame:** From enrollment to the end of surgery. **Description:** Positive predictive value (PPV) of 3D-CNN in identifying pleural adhesions using USP. PPV is calculated by dividing the number of true positive results by the total number of positive test results. A higher PPV means that the test is more reliable in correctly identifying those with the condition. **Measure:** Positive predictive value **Time Frame:** From enrollment to the end of surgery. **Description:** Negative predictive value (NPV) of 3D-CNN in identifying pleural adhesions using USP. NPV is calculated by dividing the number of true negative results by the total number of negative test results. A higher NPV means that the test is more reliable in correctly identifying those without the condition. **Measure:** Negative predictive value **Time Frame:** From enrollment to the end of surgery. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients who plan to accept VATS surgery. Exclusion Criteria: 1. Patients who can not obtain detailed clinical information; 2. Patients or their family members who can not understand the conditions and objectives of the study or refuse to participate in the study; 3. Patients with conditions affecting observation, such as skin lesions, infections, or scars in the area of the chest wall to be examined. **Maximum Age:** 80 Years **Minimum Age:** 12 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Patients who plan to accept VATS surgery in Peking Union Medical college Hospital, and agree to perform preoperative plerual ultrasound examination. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Xuehan Gao, MD **Phone:** 18801341299 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Yuanjing Gao, MD **Phone:** 16619765781 **Role:** CONTACT ### IPD Sharing Statement Module **Description:** The data of this study will be used in future analyses and be published in academic article. **IPD Sharing:** NO ### References Module #### References **Citation:** Mason AC, Miller BH, Krasna MJ, White CS. Accuracy of CT for the detection of pleural adhesions: correlation with video-assisted thoracoscopic surgery. Chest. 1999 Feb;115(2):423-7. doi: 10.1378/chest.115.2.423. **PMID:** 10027442 **Citation:** Cassanelli N, Caroli G, Dolci G, Dell'Amore A, Luciano G, Bini A, Stella F. Accuracy of transthoracic ultrasound for the detection of pleural adhesions. Eur J Cardiothorac Surg. 2012 Nov;42(5):813-8; discussion 818. doi: 10.1093/ejcts/ezs144. Epub 2012 Apr 19. **PMID:** 22518039 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002921 - Term: Cicatrix - ID: D000005355 - Term: Fibrosis - ID: D000010335 - Term: Pathologic Processes - 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 - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M13885 - Name: Pleural Diseases - Relevance: HIGH - As Found: Pleural Diseases - ID: M3620 - Name: Tissue Adhesions - Relevance: HIGH - As Found: Adhesion - ID: M6160 - Name: Cicatrix - Relevance: LOW - As Found: Unknown - ID: M8485 - Name: Fibrosis - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010995 - Term: Pleural Diseases - ID: D000000267 - Term: Tissue Adhesions ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423053 **Brief Title:** A Randomized Trial of a College Biology Course With Integrated Mindfulness **Official Title:** A Randomized Trial of a College Biology Course With Integrated Mindfulness Practice on Student Mindfulness, Learning-Related Anxiety, and Well-Being #### Organization Study ID Info **ID:** STUDY00032944 #### Organization **Class:** OTHER **Full Name:** Trustees of Dartmouth College ### Status Module #### Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-21 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-03-21 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Trustees of Dartmouth College #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The proposed study aims to evaluate whether integrating mindfulness practice into an undergraduate biology course influences student levels of mindfulness, stress, positive academic emotions, and physical, mental, and social health outcomes. These outcomes will be evaluated for students who enroll in the biology course compared to students who attempted to register but were waitlisted. **Detailed Description:** The proposed study aims to evaluate whether integrating mindfulness practice into an undergraduate biology course influences student levels of mindfulness, learning-related anxiety and well-being. A two-arm design will look at students who receive the intervention (academic course) plus usual care and a control group of waitlisted students for the course who will only receive university wellness resources. Participants all attempted to register for the course during a set course selection period at the college and were randomly registered or waitlisted by the College Registrar. Students registered and waitlisted for the course will be recruited for the study and those that provide informed consent will be enrolled. Data relating to mindfulness, learning-related anxiety, and well-being will be collected at baseline, mid-intervention (\~5 weeks), at the conclusion of the intervention (\~10 weeks), and at \~20 weeks. The primary analyses will evaluate whether there is a greater 1. increase in mindfulness, 2. increase in composite well-being score, and 3. decrease in learning-related anxiety in the intervention arm compared to the control arm. The secondary analyses will evaluate whether there is a greater 1. increase in heart rate variability and 2. reduction in hair cortisol in the intervention arm compared to the control arm. Secondary analyses will also evaluate differential changes in individual well-being score components (including physical activity, sleep, diet, alcohol use, media use, perceived stress, overall mental well-being, and loneliness). The analytical approach will examine if changes in outcomes are greater in the intervention group than in the usual care group via linear mixed-effect or linear regression models, as appropriate, adjusting for covariates. Statistical analyses will follow an "intention-to-treat" approach and include all participants, regardless of intervention completion. A p-value of \<.05 will be used as the threshold for statistical significance for all tests. In addition, any outcomes with observed statically significant differences between the arms will be re-collected and analyzed for differences at \~10 weeks post-intervention. ### Conditions Module **Conditions:** - Mindfulness - Stress Psychological - Stress, Physiological ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Students who attempted to enroll in Biology 3: Mindful Physiology at Dartmouth College during the course selection period were randomly assigned to the class or waitlist by the college registrar. The intervention is participation in Biology 3, a college biology course with integrated mindfulness practices along with usual access to the College's wellness offerings. The control condition is the waitlist for Biology 3 along with usual access to the College's wellness offerings. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This arm consists of students enrolled in Dartmouth College's Biology 3 course during Spring 2024 term, who will have access to course offerings and usual university wellness resources (as described for the control arm). **Intervention Names:** - Behavioral: Biology Course with Integrated Mindfulness **Label:** Biology 3 students **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** This arm consists of students waitlisted for Dartmouth College's Biology 3 course during Spring 2024 term. They will receive university wellness resources as usual. These include access to wellness counselors, mental health advisors, and psychiatrists at the university's counseling center, wellness advising at the student wellness center, and campus-wide wellness programs, such as weekly group yoga and meditation sessions and a free subscription to the Headspace app. The 4-hr mindfulness retreat will also be advertised to and open to all Dartmouth students. **Label:** Biology 3 waitlisted students **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Biology 3 students **Description:** This intervention is a college biology course with embedded mindfulness practice. There are 17 class sessions, each 1 hr and 50 min. long, over 9.5 weeks. Students will be taught human physiology through didactic lectures, laboratory activities, and written tests typical for a college course. Each class meeting will have \~20 min. of mindfulness practice in Thich Nhat Hanh's Plum Village tradition. Students are recommended to practice mindfulness for 15 minutes daily. Students are assigned a daily log of their mindfulness practice, and they are given full credit for each log completion regardless of the minutes of mindfulness practices. Students are assigned a weekly written reflection to reflect on the physiology course content and/or their mindfulness practice. All students in the class are required to attend a 4-hr mindfulness retreat Students in the intervention arm will also receive university wellness resources as usual as described for the control arm below. **Name:** Biology Course with Integrated Mindfulness **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Trait mindfulness will be measured via the Five Facet Mindfulness Questionnaire (FFMQ; total possible score range: 1-5; higher scores indicate higher trait mindfulness). **Measure:** Trait Mindfulness **Time Frame:** Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks) **Description:** Application of mindfulness in everyday life will be measured via the Applied Mindfulness Process Scale (AMPS; total possible score range: 0-60; higher scores indicate more application of mindfulness practice in daily life). **Measure:** Applied Mindfulness **Time Frame:** Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks) **Description:** A well-being score assessing physical, emotional, and social health and behaviors, adapted from Loucks et al. (2021): sleep (5-day accelerometry and/or Pittsburg Sleep Quality Index, total possible score range: 0-21; higher scores indicate poorer sleep quality), physical activity (International Physical Activity Questionnaire and/or 5-day accelerometry), diet (short Health Eating Index; range: 0-100; higher scores indicate higher diet quality), alcohol intake (Quick Drinking Screen), media use (Bergen Social Media Addiction Scale; range: 6-30; higher scores indicate more problematic media use), stress (Perceived Stress Scale-10; range: 0-40; higher scores indicate more perceived stress), mental well-being (Warwick-Edinburgh Mental Well-being Scale; range: 14-70; higher scores show more mental well-being), and loneliness (UCLA-Loneliness Scale; range: 0-60; higher scores show more perceived loneliness). This composite score will be the mean z-score across the above-mentioned measures. **Measure:** Composite Well-Being Score **Time Frame:** Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks) **Description:** Learning-related anxiety subscale from the Achievement Emotion Questionnaire-short version (AEQ-S; total possible score range: 1-5; higher scores indicate greater learning-related anxiety). **Measure:** Learning-Related Anxiety **Time Frame:** Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks) #### Secondary Outcomes **Description:** Measured via a polar chest strap for 24 hours **Measure:** Physiologic Stress (HRV) **Time Frame:** Baseline and intervention completion(~10 weeks) **Description:** Measured via hair cortisol concentration **Measure:** Physiologic Stress (Cortisol) **Time Frame:** Baseline and intervention completion (~10 weeks) **Description:** Measured via Self-Compassion Scale (; total possible score range: 1-5; higher scores indicate higher levels of self-compassion) **Measure:** Self-Compassion **Time Frame:** Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks) **Description:** Measured via Gratitude Questionnaire (GQ-6; total possible score range: 1-7; higher scores indicate higher levels of trait gratitude) **Measure:** Trait Gratitude **Time Frame:** Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks) **Description:** Measured via Mindful Eating Questionnaire (MEQ; total possible score range: 1-4; higher scores indicate more mindful eating) **Measure:** Mindful Eating **Time Frame:** Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks) **Description:** Each component of the composite well-being score described above will be assessed separately in secondary analyses. **Measure:** Components of Composite Well-Being Score **Time Frame:** Baseline, mid-intervention (~5 weeks), and intervention completion (~10 weeks) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Current Dartmouth student who selected Biology 3: Mindful Physiology during 2024 Spring term course enrollment period. Exclusion Criteria: - **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Hanover **Country:** United States **Facility:** Media and Health Behaviors Lab at Dartmouth **State:** New Hampshire **Zip:** 03755 #### Overall Officials **Official 1:** **Affiliation:** Dartmouth College **Name:** Diane I Gilbert-Diamond, ScD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Data Sharing Agreement Institutional Human Subjects Research Protocol Approval **Description:** De-identified participant data will be made available to other researchers upon request to the Principal Investigator with a data sharing agreement provided that the researchers have appropriate human subjects research approval. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** Data will become available October 1, 2026. ### References Module #### References **Citation:** Baer R. Assessment of mindfulness by self-report. Curr Opin Psychol. 2019 Aug;28:42-48. doi: 10.1016/j.copsyc.2018.10.015. Epub 2018 Nov 2. **PMID:** 30423507 **Citation:** Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504. **PMID:** 16443717 **Citation:** Bamber, M. D., & Schneider, J. K. (2022). College students' perceptions of mindfulness-based interventions: A narrative review of the qualitative research. Current Psychology, 41(2), 667-680. https://doi.org/10.1007/s12144-019-00592-4 **Citation:** Black, D. S. (2015). Mindfulness Training for Children and Adolsecents: A State-of-the-Science Review. In Handbook of Mindfulness: Theory, Research, and Practice (pp. 283-310). Guilford Publications. **Citation:** Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. **PMID:** 2748771 **Citation:** Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available. **PMID:** 6668417 **Citation:** Colby S, Zhou W, Allison C, Mathews AE, Olfert MD, Morrell JS, Byrd-Bredbenner C, Greene G, Brown O, Kattelmann K, Shelnutt K. Development and Validation of the Short Healthy Eating Index Survey with a College Population to Assess Dietary Quality and Intake. Nutrients. 2020 Aug 27;12(9):2611. doi: 10.3390/nu12092611. **PMID:** 32867172 **Citation:** Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB. **PMID:** 12900694 **Citation:** Dawson AF, Brown WW, Anderson J, Datta B, Donald JN, Hong K, Allan S, Mole TB, Jones PB, Galante J. Mindfulness-Based Interventions for University Students: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. Appl Psychol Health Well Being. 2020 Jul;12(2):384-410. doi: 10.1111/aphw.12188. Epub 2019 Nov 19. **PMID:** 31743957 **Citation:** Dum M, Sobell LC, Sobell MB, Heinecke N, Voluse A, Johnson K. A Quick Drinking Screen for identifying women at risk for an alcohol-exposed pregnancy. Addict Behav. 2009 Sep;34(9):714-6. doi: 10.1016/j.addbeh.2009.04.001. Epub 2009 Apr 8. **PMID:** 19406583 **Citation:** Framson C, Kristal AR, Schenk JM, Littman AJ, Zeliadt S, Benitez D. Development and validation of the mindful eating questionnaire. J Am Diet Assoc. 2009 Aug;109(8):1439-44. doi: 10.1016/j.jada.2009.05.006. **PMID:** 19631053 **Citation:** Galante J, Dufour G, Vainre M, Wagner AP, Stochl J, Benton A, Lathia N, Howarth E, Jones PB. A mindfulness-based intervention to increase resilience to stress in university students (the Mindful Student Study): a pragmatic randomised controlled trial. Lancet Public Health. 2018 Feb;3(2):e72-e81. doi: 10.1016/S2468-2667(17)30231-1. Epub 2017 Dec 19. **PMID:** 29422189 **Citation:** Lee EH. Review of the psychometric evidence of the perceived stress scale. Asian Nurs Res (Korean Soc Nurs Sci). 2012 Dec;6(4):121-7. doi: 10.1016/j.anr.2012.08.004. Epub 2012 Sep 18. **PMID:** 25031113 **Citation:** Letourneau B, Sobell LC, Sobell MB, Agrawal S, Gioia CJ. Two Brief Measures of Alcohol Use Produce Different Results: AUDIT-C and Quick Drinking Screen. Alcohol Clin Exp Res. 2017 May;41(5):1035-1043. doi: 10.1111/acer.13364. Epub 2017 Mar 31. **PMID:** 28247424 **Citation:** Li MJ, Black DS, Garland EL. The Applied Mindfulness Process Scale (AMPS): A process measure for evaluating mindfulness-based interventions. Pers Individ Dif. 2016 Apr 1;93:6-15. doi: 10.1016/j.paid.2015.10.027. **PMID:** 26858469 **Citation:** Liu D, Kahathuduwa C, Vazsonyi AT. The Pittsburgh Sleep Quality Index (PSQI): Psychometric and clinical risk score applications among college students. Psychol Assess. 2021 Sep;33(9):816-826. doi: 10.1037/pas0001027. Epub 2021 May 20. **PMID:** 34014747 **Citation:** Shapiro, S. L., & Jazaieri, H. (2015). Mindfulness-Based Stress Reduction for Healthy Stressed Adults. In Handbook of mindfulness: Theory, research, and practice (pp. 269-282). The Guilford Press. **Citation:** Sobell LC, Agrawal S, Sobell MB, Leo GI, Young LJ, Cunningham JA, Simco ER. Comparison of a quick drinking screen with the timeline followback for individuals with alcohol problems. J Stud Alcohol. 2003 Nov;64(6):858-61. doi: 10.15288/jsa.2003.64.858. **PMID:** 14743950 **Citation:** Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63. **PMID:** 18042300 **Citation:** Loucks EB, Nardi WR, Gutman R, Saadeh FB, Li Y, Vago DR, Fiske LB, Spas JJ, Harrison A. Mindfulness-Based College: A Stage 1 Randomized Controlled Trial for University Student Well-Being. Psychosom Med. 2021 Jul-Aug 01;83(6):602-614. doi: 10.1097/PSY.0000000000000860. **PMID:** 32947581 **Citation:** Bieleke, M., Gogol, K., Goetz, T., & Pekrun, R. (in press). The AEQ-S: A short version of the Achievement Emotions Questionnaire. Contemporary Educational Psychology, 101940. Advance online publication. https://doi.org/10.1016/j.cedpsych.2020.101940 **Citation:** Greeson JM, Juberg MK, Maytan M, James K, Rogers H. A randomized controlled trial of Koru: a mindfulness program for college students and other emerging adults. J Am Coll Health. 2014;62(4):222-33. doi: 10.1080/07448481.2014.887571. **PMID:** 24499130 **Citation:** John D, Tang Q, Albinali F, Intille S. An Open-Source Monitor-Independent Movement Summary for Accelerometer Data Processing. J Meas Phys Behav. 2019 Dec;2(4):268-281. doi: 10.1123/jmpb.2018-0068. **PMID:** 34308270 **Citation:** Wright KD, Hickman R, Laudenslager ML. Hair Cortisol Analysis: A Promising Biomarker of HPA Activation in Older Adults. Gerontologist. 2015 Jun;55 Suppl 1(Suppl 1):S140-5. doi: 10.1093/geront/gnu174. **PMID:** 26055775 **Citation:** Li K, Cardoso C, Moctezuma-Ramirez A, Elgalad A, Perin E. Heart Rate Variability Measurement through a Smart Wearable Device: Another Breakthrough for Personal Health Monitoring? Int J Environ Res Public Health. 2023 Dec 6;20(24):7146. doi: 10.3390/ijerph20247146. **PMID:** 38131698 **Citation:** Mccullough ME, Emmons RA, Tsang JA. The grateful disposition: a conceptual and empirical topography. J Pers Soc Psychol. 2002 Jan;82(1):112-27. doi: 10.1037//0022-3514.82.1.112. **PMID:** 11811629 **Citation:** Neff, K.D. The Self-Compassion Scale is a Valid and Theoretically Coherent Measure of Self-Compassion. Mindfulness 7, 264-274 (2016). https://doi.org/10.1007/s12671-015-0479-3 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423040 **Brief Title:** Social Media Chatbot on Physical Activity Education for Older Adults **Official Title:** Exploring the Effectiveness of Applying Social Media Chatbot for Providing Real-Time Feedback on Physical Activity Education for Older Adults #### Organization Study ID Info **ID:** N202403043 #### Organization **Class:** OTHER **Full Name:** Taipei Medical University ### Status Module #### Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Taipei Medical University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** In this study, a social media chatbot was used to provide a continuous and real-time multimedia health education program on physical activity for the older adults, as well as supportive messages and feedbacks, to improve physical activity and exercise self-efficacy among the older adults. This study was a cluster randomized trial, and participants were recruited from community care stations and activity centers in Taipei City. The experimental group was involved in an 8-week, 5-day-a-week intervention with a total of 40 multimedia physical activity education programs, and users were provided with real-time feedback interactions and regular physical activity education guidelines, and self-administered questionnaires were used for data collection. The research instruments include basic personal information, International Physical Activity Questionnaire, Exercise Self-Efficacy Scale, Behavioral regulation in exercise questionnaire-2, Exercise Benefits/Barriers Scale, and the statistical methods will be descriptive statistics, independent sample t-test, paired sample t-test, and one-way analysis of covariance. ### Conditions Module **Conditions:** - Exercise - Self Efficacy - Behavioral Regulation - Healthy Aging ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 104 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Label:** Control **Type:** NO_INTERVENTION #### Arm Group 2 **Intervention Names:** - Other: Social Media Chatbot on Physical Activity Education **Label:** Experiment **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Experiment **Description:** a social media chatbot was used to provide a continuous and real-time multimedia health education program on physical activity for the older adults, as well as supportive messages and feedbacks. **Name:** Social Media Chatbot on Physical Activity Education **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** International Physical Activity Questionnaire **Measure:** Physical activity **Time Frame:** up to 8 weeks **Description:** Exercise Self-Efficacy Scale **Measure:** Self-Efficacy **Time Frame:** up to 8 weeks **Description:** Behavioral regulation in exercise questionnaire-2 **Measure:** Behavioral regulation **Time Frame:** up to 8 weeks **Description:** Exercise Benefits/Barriers Scale **Measure:** Benefits/Barriers **Time Frame:** up to 8 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Persons aged 60 to 85 years old living in Taipei City, healthy or with chronic conditions 2. Those who can listen, read and write Chinese 3. Those who have used smartphones in the past month and can use Line social software 4. Those who voluntarily participate in this study, can understand the research content after explanation and explanation, and sign the subject consent form Exclusion Criteria: 1. Those who are advised by a doctor not to exercise 2. Those who must exercise under the supervision of medical personnel 3. Patients with severe cardiovascular disease 4. Anyone with disability or cognitive impairment 5. Persons living in long-term care institutions **Healthy Volunteers:** True **Maximum Age:** 85 Years **Minimum Age:** 60 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423027 **Brief Title:** Nature-Oriented Chatbots on Older Adults' Mental Health **Official Title:** Exploring the Influence of Nature-Oriented Chatbots on the Mental Health of Older Adults Living Alone #### Organization Study ID Info **ID:** N202403042 #### Organization **Class:** OTHER **Full Name:** Taipei Medical University ### Status Module #### Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Taipei Medical University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study aims to explore the influence of nature-oriented chatbots on the mental health of older adults residing alone. Leveraging the therapeutic potential of nature exposure and the interactive capabilities of chatbot technology, our research seeks to investigate whether engaging with nature-oriented chatbots can mitigate feelings of depression, and loneliness while enhancing overall psychological well-being and quality of life. Through a combination of experimental interventions and psychological assessments, the investigators will assess the impact of nature-oriented chatbots on participants' mental health outcomes. ### Conditions Module **Conditions:** - Depression - Loneliness - Happiness - Connection With Nature - Anxiety ### 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 **Label:** Control **Type:** NO_INTERVENTION #### Arm Group 2 **Intervention Names:** - Behavioral: Nature-Oriented Chatbots **Label:** Experiment **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Experiment **Description:** Nature-oriented chatbots are an intervention with nature-based video delivered by self-developed chatbots **Name:** Nature-Oriented Chatbots **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The Geriatric Depression Scale **Measure:** Depression **Time Frame:** up to 8 weeks **Description:** UCLA loneliness (ULS-8) **Measure:** loneliness **Time Frame:** up to 8 weeks **Description:** Well-being of Older People measure (WOOP) **Measure:** happiness **Time Frame:** up to 8 weeks **Description:** Connectedness with nature scale (CNS） **Measure:** connection with nature **Time Frame:** up to 8 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Individuals aged 60 years and above who live alone. 2. Regular users of smartphones, with internet access, and proficient in using LINE. 3. Individuals who consent to participate in the study and sign the consent form. 4. Capable of understanding interactive messages and the content of pre- and post-test questionnaires. Exclusion Criteria: 1. Individuals without smartphones, internet access, or not using LINE. 2. Diagnosed with sensory impairments. 3. Diagnosed with mental illnesses requiring continuous treatment. **Healthy Volunteers:** True **Maximum Age:** 90 Years **Minimum Age:** 60 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ## 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: 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:** NCT06423014 **Brief Title:** Smart mHealth Strategy for Physical Activity and Health Promotion **Official Title:** Smart mHealth Strategy in the Delivery of Behavior Change Techniques for Physical Activity and Health Promotion #### Organization Study ID Info **ID:** N202303041 #### Organization **Class:** OTHER **Full Name:** Taipei Medical University ### Status Module #### Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-07 **Type:** ESTIMATED #### Start Date **Date:** 2023-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Taipei Medical University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The purpose of this study is to develop a Smart mHealth Strategy that delivers behavior change techniques through wearable physical activity trackers and social media chatbots, including self-monitoring, real-time feedback and reminders, goal-setting, competition and rewards, social support, and health coaching. This study also aims to explore the effect of the Smart mHealth Strategy on the behavioral outcomes and psychological factors of physical activity, and physical and mental health. The study design is a three-stage randomized controlled trial. In each stage, 120 are recruited and randomly assigned to control and experimental groups. Participants are adults with insufficient physical activity and a sedentary lifestyle. The Smart mHealth Strategy uses smartwatches and self-developed chatbots. The constrained dialogue content is designed to finally deliver the six behavior change techniques. Data are collected in the pre-, mid-, and post-tests. The measurement includes self-administered questionnaires, Actigraphy GT9X, Inbody 270S, OMRON HEM-7130, and heart rate variability monitors. ### Conditions Module **Conditions:** - Health Behavior Change - Wearable Technology - Chatbot - Social Media - Sedentary Lifestyle ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 360 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Label:** Control **Type:** NO_INTERVENTION #### Arm Group 2 **Intervention Names:** - Behavioral: Wearable devices only - Behavioral: Wearable devices with the 1st behavior change technique - Behavioral: Wearable devices with the 2nd behavior change technique - Behavioral: Wearable devices with the 3rd behavior change technique - Behavioral: Wearable devices with the 4th behavior change technique - Behavioral: Wearable devices with the 5th behavior change technique - Behavioral: Wearable devices with all behavior change techniques **Label:** Wearable devices only **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Intervention Names:** - Behavioral: Wearable devices only - Behavioral: Wearable devices with all behavior change techniques **Label:** Wearable devices with the 1st behavior change technique **Type:** EXPERIMENTAL #### Arm Group 4 **Intervention Names:** - Behavioral: Wearable devices only - Behavioral: Wearable devices with all behavior change techniques **Label:** Wearable devices with the 2nd behavior change technique **Type:** EXPERIMENTAL #### Arm Group 5 **Intervention Names:** - Behavioral: Wearable devices only - Behavioral: Wearable devices with all behavior change techniques **Label:** Wearable devices with the 3rd behavior change technique **Type:** EXPERIMENTAL #### Arm Group 6 **Intervention Names:** - Behavioral: Wearable devices only - Behavioral: Wearable devices with all behavior change techniques **Label:** Wearable devices with the 4th behavior change technique **Type:** EXPERIMENTAL #### Arm Group 7 **Intervention Names:** - Behavioral: Wearable devices only - Behavioral: Wearable devices with all behavior change techniques **Label:** Wearable devices with the 5th behavior change technique **Type:** EXPERIMENTAL #### Arm Group 8 **Intervention Names:** - Behavioral: Wearable devices only - Behavioral: Wearable devices with all behavior change techniques **Label:** Wearable devices with all behavior change techniques **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Wearable devices only - Wearable devices with all behavior change techniques - Wearable devices with the 1st behavior change technique - Wearable devices with the 2nd behavior change technique - Wearable devices with the 3rd behavior change technique - Wearable devices with the 4th behavior change technique - Wearable devices with the 5th behavior change technique **Description:** self-monitoring **Name:** Wearable devices only **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Wearable devices only **Description:** reminder **Name:** Wearable devices with the 1st behavior change technique **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - Wearable devices only **Description:** social support **Name:** Wearable devices with the 2nd behavior change technique **Type:** BEHAVIORAL #### Intervention 4 **Arm Group Labels:** - Wearable devices only **Description:** Competition **Name:** Wearable devices with the 3rd behavior change technique **Type:** BEHAVIORAL #### Intervention 5 **Arm Group Labels:** - Wearable devices only **Description:** Goal-setting **Name:** Wearable devices with the 4th behavior change technique **Type:** BEHAVIORAL #### Intervention 6 **Arm Group Labels:** - Wearable devices only **Description:** health coach **Name:** Wearable devices with the 5th behavior change technique **Type:** BEHAVIORAL #### Intervention 7 **Arm Group Labels:** - Wearable devices only - Wearable devices with all behavior change techniques - Wearable devices with the 1st behavior change technique - Wearable devices with the 2nd behavior change technique - Wearable devices with the 3rd behavior change technique - Wearable devices with the 4th behavior change technique - Wearable devices with the 5th behavior change technique **Description:** Self-monitoring, health coach, goal-setting, competition, social support, and reminder **Name:** Wearable devices with all behavior change techniques **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** International Physical Activity Questionnaire (IPAQ-SF, MET-minute/week) **Measure:** Subjective physical activity **Time Frame:** up to 12 weeks **Description:** Actigraphy GT9X and GT3X (MET-minute/week) **Measure:** Objective physical activity **Time Frame:** up to 12 weeks **Description:** Higher score higher benefits and barriers **Measure:** Exercise Benefits/Barriers Scale-Concise (EBBS-C) **Time Frame:** up to 12 weeks **Description:** Higher score higher self-efficacy **Measure:** Exercise self-efficacy scale (EXSE) **Time Frame:** up to 12 weeks **Description:** Higher score higher Self-Regulation **Measure:** Physical Activity Self-Regulation Scale (PASR) **Time Frame:** up to 12 weeks **Description:** Higher score higher Behavioural Regulation **Measure:** Behavioural Regulation in Exercise Questionnaire (BREQ-3) **Time Frame:** up to 12 weeks #### Secondary Outcomes **Description:** Body mass index (BMI, kg/m\^2), skeletal muscle index (SMI, kg/m\^2), body fat percentage (%), body fat mass (kg), and fat-free mass (kg) **Measure:** body composition (Inbody) **Time Frame:** up to 12 weeks **Description:** Systolic and diastolic blood pressure (mmHg) **Measure:** blood pressure **Time Frame:** up to 12 weeks **Description:** Total power (TP, 0-0.5 Hz), low-frequency power (LF, 0.04-0.15 Hz), high-frequency power (HF, 0.15-0.40 Hz), the ratio of low frequency to high frequency (LF/HF), and the standard deviation of all normal-to-normal intervals (SDNN) **Measure:** heart rate variability **Time Frame:** up to 12 weeks **Description:** Higher score worse mental health **Measure:** Depression Anxiety Stress Scale (DASS) **Time Frame:** up to 12 weeks **Description:** Higher score higher Quality of Life **Measure:** World Health Organization Quality of Life Scale (WHOQOL-BREF) **Time Frame:** up to 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Adults who is the age of majority, with insufficient physical activity, and a sedentary lifestyle who have smartphones Exclusion Criteria: * Individuals' health conditions may affect physical activity in daily living and the experiment, such as disability, serious health problems * There are unconventional life plans during the experiment, such as going abroad for vacation, pregnancy, and surgery. * Individuals have using experiences in any wearable physical activity trackers in the past six months ④ People who have ever had severe allergies to any wearable device ⑤ Professional athletes or student-athletes **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Hsin-Yen Yen, PhD **Phone:** 886-2-2736-1661 **Phone Ext:** 6326 **Role:** CONTACT #### Locations **Location 1:** **City:** Taipei City **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Hsin-Yen Yen, PhD - **Phone:** 886-2-2736-1661 - **Phone Ext:** 6326 - **Role:** CONTACT **Country:** Taiwan **Facility:** Taipei Medical University **Status:** RECRUITING **Zip:** 110 ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06423001 **Acronym:** prePO23 **Brief Title:** Efficacy and Safety of Oral Administration of Postibiotic by FOS Fermentation From Lactobacillus Paracasei in the Treatment of Irritable Bowel Syndrome. **Official Title:** A Randomized, Cross-over, Placebo-Controlled, Double-Blind Clinical Trial on the Efficacy and Safety of Oral Administration of Postibiotic by FOS Fermentation From Lactobacillus Paracasei in the Treatment of Irritable Bowel Syndrome. #### Organization Study ID Info **ID:** ID 2939 #### Organization **Class:** OTHER **Full Name:** Istituto Clinico Humanitas ### Status Module #### Completion Date **Date:** 2026-05-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-04-24 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Istituto Clinico Humanitas #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Irritable bowel syndrome (IBS) is a highly prevalent functional pathology which currently has no real standardized and effective therapy, despite having a significant impact on quality of life and on social-health costs. Post-biotics have demonstrated in various in vitro and in vivo studies the ability to modulate the microbiota, the intestinal barrier function, the immune response as well as having systemic effects, with prospects for good efficacy in treatment of IBS. **Detailed Description:** PostbiotiX Slowing is a food supplement based on Fermented FOS from Lactobacillus paracasei CNCM I-5220, mallow and chamomile. The Fermented FOS from Lactobacillus paracasei CNCM I-5220 (postbiotic) is the result of a controlled fermentation. The fermentation process allows to eliminate all the individual variability that depends on the microbiota, the diet and the psycho-physical conditions of the single individual, offering a mixture of bacterial metabolites and fermented fiber (postbiotic), which has the functional activity. In addition, as FOS is already fermented it does not induce the formation of gas typical of fiber fermentation in IBS patients, thus providing all the beneficial effects of the fiber without its side effects. The fermented FOS from Lactobacillus paracasei CNCM I-5220 (postbiotic) is easily absorbed by the gut. Dosage and method of use: PostbiotiX Slowing 4 g sachets, administered at the dosage of one sachet a day. To pour the contents of the sachet in a glass, add 150 ml of water, mix until complete dissolution of the powder and taken immediately, preferably as soon as awakened, and away from meals. Ingredients: Maltodextrin, Aroma, Fermented FOS from Lactobacillus paracasei CNCM I-5220, mallow (Malva sylvestris L.) flowers and leaves d.e. tit. 20% polysaccharides, chamomile (Matricaria chamomilla L.) flowers d.e. tit. 0.3% apigenin, acidity regulator: citric acid; anti-caking agent: silicon dioxide; sweetener: sucralose. Conservation method: to be kept in a cool and dry place, away from light, humidity, and direct sources of heat. ### Conditions Module **Conditions:** - IBS - Irritable Bowel Syndrome ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** OTHER #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Each patient will be supplied with the investigational product at Visit 0 (V0, Kit V0, PostibiotiX Slowing) and at visit 3 (V3, Kit V3, Placebo), based on the outcome of the randomization at V0 (Sequence AB, PostbiotiX Slowing/Placebo). **Intervention Names:** - Dietary Supplement: PostbiotiX Slowing 4 g sachets PostbiotiX Slowing is a food supplement based on Fermented FOS from Lactobacillus paracasei CNCM I-5220. **Label:** PostbiotiX Slowing (Treatment A) Sequence AB **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Each patient will be supplied with the investigational product at Visit 0 (V0, Kit V0, Placebo) and at visit 3 (V3, Kit V3, PostibiotiX Slowing), based on the outcome of the randomization at V0 (Sequence BA, Placebo/PostbiotiX Slowing). **Intervention Names:** - Dietary Supplement: PostbiotiX Slowing 4 g sachets PostbiotiX Slowing is a food supplement based on Fermented FOS from Lactobacillus paracasei CNCM I-5220. **Label:** Placebo (Tratment B) Sequence BA **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Placebo (Tratment B) Sequence BA - PostbiotiX Slowing (Treatment A) Sequence AB **Description:** Each patient will be supplied with the investigational product at Visit 0, PostibiotiX Slowing and at visit 3, based on the outcome of the randomization at V0 (Sequence AB, PostbiotiX Slowing/Placebo; Sequence BA, Placebo/PostbiotiX Slowing). **Name:** PostbiotiX Slowing 4 g sachets PostbiotiX Slowing is a food supplement based on Fermented FOS from Lactobacillus paracasei CNCM I-5220. **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Evaluated using a symptom measurement scale, at each visit, on a 4-point Likert scale (IBS symptom scale; 4 symptoms for a minimum sum score of 0, maximum 12). **Measure:** Reduction in symptom intensity **Time Frame:** 10 weeks #### Secondary Outcomes **Description:** IBS-SSS is a five-item questionnaire measuring frequency and intensity of abdominal pain, the severity of abdominal distension, dissatisfaction with bowel habits, and the interference of IBS with daily life, scoring from 0 to 500. **Measure:** Change from baseline in IBS-SSS (symptom severity score) **Time Frame:** up to 4 weeks **Description:** To assess adequate overall relief, patients will be asked weekly to answer the question "Compared to how you usually felt before taking the treatment, how would you rate your symptom relief (abdominal pain, bowel habits, and other symptoms of IBS) in the past 10 days?" Possible answers: 1, very relieved; 2, relieved; 3, somewhat relieved; 4, unchanged; 5, slightly worsened; 6, worsened; 7, much worsened. **Measure:** Adequate overall symptom relief after treatment, **Time Frame:** up to 10 days **Description:** Severity score of each of the individual symptoms included in the IBS-SSS (VAS sub-scores), assessed by numeric rating scale (NRS) from 0 to 100 **Measure:** Change from baseline after treatment in NRS: **Time Frame:** up to 10 days **Description:** Quality of life as assessed by IBS-QoL: The individual responses to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life **Measure:** Change from baseline after treatment in QqL: **Time Frame:** up to 10 days **Description:** Hospital anxiety and depression scale (HADS): HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score \>8 denotes anxiety or depression. **Measure:** Change from baseline after treatment in HADS: **Time Frame:** up to 10 days **Description:** Additional functional parameters in stool analysis differences before and after treatment (for example: digestive residues, bile acids, proteic composition) **Measure:** Fecal metagenomics: **Time Frame:** up to 10 days **Description:** Differences before and after treatment in the Sieric/plasma molecules such as for example Zonulin, soluble CD14, plasmatic inflammatory cytokines, bacterial DNA in the blood, and PBMCs analysis **Measure:** Analyses of metabolomic: **Time Frame:** up to 10 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18-75 years * IBS diagnosis according to ROME IV criteria * Mild-moderate disease defined by IBS-SSS questionnaire at the baseline visit and after the washout period * Signed Informed Consent * Patients' ability to comply with the study procedures * Stable diet within two months prior to the screening visit * Negative colonoscopy (only \> 50 years old patients) Exclusion Criteria: * Therapy with drugs or supplements included in the prohibited list * Malignancy or history of malignancy, except patients with a history of surgically removed extraintestinal malignancy and a 5-year disease-free interval * Unstable psychiatric pathology * Organic bowel disease * Major abdominal surgery, except appendectomy and cholecystectomy * Relevant organic, systemic, metabolic pathologies or significant laboratory test abnormalities * Pregnant or nursing women * Patients with known hypersensitivity to one or more components of the product **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Alessandro Repici, MD **Phone:** 0282247493 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Vincenzo Craviotto, MD **Phone:** 0282243113 **Role:** CONTACT #### Locations **Location 1:** **City:** Rozzano **Country:** Italy **Facility:** Department of Gastroenterology, Humanitas Research Hospital **State:** Milano **Zip:** 20089 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Lacy BE, Pimentel M, Brenner DM, Chey WD, Keefer LA, Long MD, Moshiree B. ACG Clinical Guideline: Management of Irritable Bowel Syndrome. Am J Gastroenterol. 2021 Jan 1;116(1):17-44. doi: 10.14309/ajg.0000000000001036. **PMID:** 33315591 **Citation:** Oka P, Parr H, Barberio B, Black CJ, Savarino EV, Ford AC. Global prevalence of irritable bowel syndrome according to Rome III or IV criteria: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2020 Oct;5(10):908-917. doi: 10.1016/S2468-1253(20)30217-X. Epub 2020 Jul 20. Erratum In: Lancet Gastroenterol Hepatol. 2020 Dec;5(12):e8. **PMID:** 32702295 **Citation:** Inadomi JM, Fennerty MB, Bjorkman D. Systematic review: the economic impact of irritable bowel syndrome. Aliment Pharmacol Ther. 2003 Oct 1;18(7):671-82. doi: 10.1046/j.1365-2036.2003.t01-1-01736.x. **PMID:** 14510740 **Citation:** Camilleri M. Management Options for Irritable Bowel Syndrome. Mayo Clin Proc. 2018 Dec;93(12):1858-1872. doi: 10.1016/j.mayocp.2018.04.032. **PMID:** 30522596 **Citation:** Salminen S, Collado MC, Endo A, Hill C, Lebeer S, Quigley EMM, Sanders ME, Shamir R, Swann JR, Szajewska H, Vinderola G. The International Scientific Association of Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of postbiotics. Nat Rev Gastroenterol Hepatol. 2021 Sep;18(9):649-667. doi: 10.1038/s41575-021-00440-6. Epub 2021 May 4. Erratum In: Nat Rev Gastroenterol Hepatol. 2021 Jun 15;: Nat Rev Gastroenterol Hepatol. 2022 Aug;19(8):551. **PMID:** 33948025 **Citation:** Tsilingiri K, Barbosa T, Penna G, Caprioli F, Sonzogni A, Viale G, Rescigno M. Probiotic and postbiotic activity in health and disease: comparison on a novel polarised ex-vivo organ culture model. Gut. 2012 Jul;61(7):1007-15. doi: 10.1136/gutjnl-2011-300971. Epub 2012 Feb 1. **PMID:** 22301383 **Citation:** Tsilingiri K, Rescigno M. Postbiotics: what else? Benef Microbes. 2013 Mar 1;4(1):101-7. doi: 10.3920/BM2012.0046. **PMID:** 23271068 **Citation:** Aguilar-Toala JE, Arioli S, Behare P, Belzer C, Berni Canani R, Chatel JM, D'Auria E, de Freitas MQ, Elinav E, Esmerino EA, Garcia HS, da Cruz AG, Gonzalez-Cordova AF, Guglielmetti S, de Toledo Guimaraes J, Hernandez-Mendoza A, Langella P, Liceaga AM, Magnani M, Martin R, Mohamad Lal MT, Mora D, Moradi M, Morelli L, Mosca F, Nazzaro F, Pimentel TC, Ran C, Ranadheera CS, Rescigno M, Salas A, Sant'Ana AS, Sivieri K, Sokol H, Taverniti V, Vallejo-Cordoba B, Zelenka J, Zhou Z. Postbiotics - when simplification fails to clarify. Nat Rev Gastroenterol Hepatol. 2021 Nov;18(11):825-826. doi: 10.1038/s41575-021-00521-6. No abstract available. **PMID:** 34556825 **Citation:** Ma L, Tu H, Chen T. Postbiotics in Human Health: A Narrative Review. Nutrients. 2023 Jan 6;15(2):291. doi: 10.3390/nu15020291. **PMID:** 36678162 **Citation:** Adams CA. The probiotic paradox: live and dead cells are biological response modifiers. Nutr Res Rev. 2010 Jun;23(1):37-46. doi: 10.1017/S0954422410000090. Epub 2010 Apr 20. **PMID:** 20403231 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000003109 - Term: Colonic Diseases, Functional - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M25118 - Name: Irritable Bowel Syndrome - Relevance: HIGH - As Found: Irritable Bowel Syndrome - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M6337 - Name: Colonic Diseases, Functional - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000043183 - Term: Irritable Bowel Syndrome - ID: D000013577 - Term: Syndrome ### Intervention Browse Module - Browse Branches - Abbrev: Ot - Name: Other Dietary Supplements - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T355 - Name: Acidophilus - Relevance: HIGH - As Found: Next ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422988 **Brief Title:** Do Probiotics Reduce The Risk Of Severe Necrotising Enterocolitis (NEC) In Infants Born Before 32 Weeks Gestation? **Official Title:** Do Probiotics Reduce The Risk Of Severe Necrotising Enterocolitis (NEC) In Infants Born Before 32 Weeks Gestation? An Observational Study Using Routinely Collected Data. #### Organization Study ID Info **ID:** IRAS323099 #### Organization **Class:** OTHER **Full Name:** Imperial College London ### Status Module #### Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-18 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2024-07-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-04-24 **Study First Submit QC Date:** 2024-05-18 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Nottingham **Class:** OTHER **Name:** Newcastle University **Class:** OTHER **Name:** Queen Mary University of London #### Lead Sponsor **Class:** OTHER **Name:** Imperial College London #### Responsible Party **Investigator Affiliation:** Imperial College London **Investigator Full Name:** Cheryl Battersby **Investigator Title:** Clinical Senior Lecturer **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Necrotising enterocolitis (NEC) is one of the leading causes of mortality and morbidity in very preterm infants. This study aims to determine whether NEC rates are different between infants who receive probiotics versus infants who do not receive probiotics. The study has a retrospective cohort design and will utilise routinely collected data from the UK National Neonatal Research Database (NNRD). The cohort will comprise all infants born before 32 weeks gestation and cared for in neonatal units in England and Wales between 2016 and 2022. A propensity score matched approach will be used to conduct two comparisons: i) the risk of necrotising enterocolitis (NEC) between who do and those who do not receive probiotics in the first 14 days of life ii) the risk of NEC between babies who receive the two most common probiotic products used in UK units, (Labinic and Proprems). ### Conditions Module **Conditions:** - Enterocolitis, Necrotizing **Keywords:** - Probiotics ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 48000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Receipt of any probiotic in the first 14 days of life. Probiotics to include: Labinic, Proprems probiotic, Acidophillus, Bifidobacterium, Bio-kult, Infloran, LB2. To address potential recording error, infants whose NNRD records show minimal (one day) of probiotic exposure will only be classed as exposed if they are cared for in a probiotic unit. Probiotic units are defined as: * units who have confirmed that a guideline was in place to provide probiotics to infants born before 32 weeks gestation and that the guideline was in place at any point in the year that the infant was born OR * units where more than 50% of the infants eligible to be part of the cohort received probiotics in the six months after the infant was born. **Intervention Names:** - Dietary Supplement: Probiotics **Label:** Exposed to probiotics #### Arm Group 2 **Description:** Did not receive any probiotic in the first 14 days of life. **Intervention Names:** - Dietary Supplement: Probiotics **Label:** No probiotic exposure ### Interventions #### Intervention 1 **Arm Group Labels:** - Exposed to probiotics - No probiotic exposure **Description:** Any exposure to probiotics in first 14 days of life **Name:** Probiotics **Other Names:** - Labinic - Proprems - Acidophillus - Bifidobacterium - Bio-kult - Infloran - LB2 **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** NEC confirmed at surgery or postmortem or listed as a cause of death **Measure:** Severe necrotising enterocolitis (NEC) **Time Frame:** From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months #### Secondary Outcomes **Description:** NEC diagnosed at postmortem or NEC diagnosed during surgery or NEC diagnosed using clinical and radiographic features (where the infant has at least one clinical feature (bilious gastric aspirate or emesis, abdominal distension, occult, gross blood in stool) and at least one radiographic feature (pneumatosis, hepato-biliary gas, pneumoperitoneum)). **Measure:** Necrotising enterocolitis (NNAP definition) **Time Frame:** From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months **Description:** Infants who had a recorded diagnosis of necrotising enterocolitis and received at least 5 consecutive days of antibiotics whilst also nil by mouth **Measure:** Pragmatically defined NEC **Time Frame:** From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months **Description:** HQIP NNAP case definition **Measure:** Late onset sepsis **Time Frame:** From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months **Description:** Growth of any organisms that appear in the NNAP lists of "Clearly pathogenic organisms" and "Other organisms" **Measure:** Pragmatically defined late onset sepsis **Time Frame:** From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months **Measure:** Survival to discharge home **Time Frame:** On date of discharge from final neonatal unit, assessed up to 24 months **Description:** LOS is defined according to the Healthcare Quality Improvement Partnership (HQIP) National Neonatal Audit Programme (NNAP) case definition i.e. blood stream or cerebrospinal fluid confirmed pure growth in culture after first three days of life **Measure:** Survival without severe NEC or late onset sepsis (LOS) **Time Frame:** From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months **Description:** NEC is defined as per the NNAP definition **Measure:** Survival without any NEC **Time Frame:** From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months **Description:** Either left or right grade 3 or higher intra-ventricular haemorrhage or cystic periventricular leukomalacia **Measure:** Brain injury **Time Frame:** From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months **Description:** Defined as cryotherapy, laser therapy or injection of anti-vascular endothelial growth factor therapy for ROP in either or both eyes **Measure:** Treated retinopathy of prematurity **Time Frame:** From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months **Measure:** Stage of retinopathy of prematurity **Time Frame:** From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months **Description:** Defined as any respiratory or ventilatory support or supplemental oxygen at 36 weeks postmenstrual age **Measure:** Bronchopulmonary dysplasia **Time Frame:** 36 weeks postmenstrual age **Description:** Defined as ventilation via endotracheal tube or trachestomy, and excluding non-invasive support or CPAP, at 36 weeks postmenstrual age **Measure:** Severe bronchopulmonary dysplasia **Time Frame:** 36 weeks postmenstrual age **Description:** Number of days between first neonatal unit admission and final neonatal unit discharge for surviving infants **Measure:** Length of stay **Time Frame:** From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months **Description:** Defined as the number of days until an infant is recorded as not requiring any parenteral nutrition or fluid (i.e. no parenteral nutrition or intravenous dextrose) **Measure:** Time to full feeds **Time Frame:** Before discharge from final neonatal unit **Description:** Weight for post-menstrual age standard deviation score **Measure:** Growth **Time Frame:** 36 weeks corrected gestational age ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Eligible infants must have been born at less than 32 weeks gestation and be cared for in a English or Welsh unit which contributes data to the National Neonatal Research Database (this includes all NHS neonatal units in England and Wales). * Infants born in the period January 1st, 2016, to December 31st, 2022 (7 years) will be included. Exclusion Criteria: * They have missing data for any of: gestational age at birth, birth weight, year of birth and date of death (for those that died). * Their NNRD record does not include details of their first admission or begins after Day 3 of life. * The absolute value of their recorded birthweight for gestational age z score exceeds 4 or is missing. * They die in the first two postnatal days of life. * They have a major congenital abnormality **Maximum Age:** 32 Weeks **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD **Study Population:** Infants born very preterm i.e. before 32 weeks gestation ### Contacts Locations Module #### Locations **Location 1:** **City:** London **Country:** United Kingdom **Facility:** Imperial College **Zip:** SW10 9NH ### IPD Sharing Statement Module **Description:** Study protocol available now. Analysis code will be available after publication of results. **IPD Sharing:** UNDECIDED ## Document Section ### Large Document Module #### Large Docs - Date: 2024-04-12 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 1459636 - Type Abbrev: Prot_SAP - Upload Date: 2024-04-23T05:17 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005759 - Term: Gastroenteritis - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000007410 - Term: Intestinal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M7922 - Name: Enterocolitis - Relevance: HIGH - As Found: Enterocolitis - ID: M22151 - Name: Enterocolitis, Necrotizing - Relevance: HIGH - As Found: Enterocolitis, Necrotizing - 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: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: T4055 - Name: Necrotizing Enterocolitis - Relevance: HIGH - As Found: Enterocolitis, Necrotizing ### Condition Browse Module - Meshes - ID: D000004760 - Term: Enterocolitis - ID: D000020345 - Term: Enterocolitis, Necrotizing ### Intervention Browse Module - Browse Branches - Abbrev: Ot - Name: Other Dietary Supplements - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T367 - Name: Bifidobacterium - Relevance: HIGH - As Found: Neural ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422975 **Brief Title:** Registry of Patients in Shock Treated With Vasopressin **Official Title:** Prospective Multicentre Observational Study of Patients Treated With Vasopressin in Critical Care Units #### Organization Study ID Info **ID:** VASOPRES REGISTRY #### Organization **Class:** OTHER **Full Name:** Hospital Universitario 12 de Octubre ### Status Module #### Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-04-29 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hospital Universitario 12 de Octubre #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Arginine-vasopressin (AVP) is a non-catecholaminergic hormone produced in the hypothalamus and released into the circulation via the neurohypophysis. It has different actions depending on the receptors through which it acts: V1 (vasoconstriction, platelet aggregation, efferent arteriole constriction of the renal glomerulus, glycogenolysis); V2 (water reabsorption, release of von Willebrand factor and factor VIII); V3 (increased cortisol and insulin). Septic shock is the most common cause of vasoplegic shock and its management includes control of the focus, early antibiotic therapy, volume resuscitation, vasopressor therapy, support of various organ dysfunctions, as well as monitoring and follow-up. The Surviving Sepsis Campaign (a global initiative to improve sepsis management) recommends noradrenaline as the first line of vasopressor therapy and early addition of AVP as a second line rather than further up-titration of noradrenaline when signs of hypoperfusion persist, through its action primarily on V1. The rationale for its use in septic shock would be: * endogenous vasopressin deficiency present in septic shock; * as a catecholamine-sparing strategy, reducing the side effects of catecholamines; * its potential nephroprotective effect; * its use should be early. The uncertainties surrounding the use of AVP in septic shock and other types of shock are many, hence the need for this registry. **Detailed Description:** The main objective is to characterise the routine clinical practice of vasopressin use in the context of shock in a multicentre observational study. By collecting clinical, analytical and echocardiographic data in a uniform manner, describing the time sequence of vasopressin and/or noradrenaline use; how long vasopressin is used; and which vasoconstrictor is more frequently withdrawn earlier: vasopressin or noradrenaline. The secondary objectives are: * to assess what motivated the decision to initiate AVP: type of shock, perfusion parameters, noradrenaline dose; * to define the impact of initiating AVP on noradrenaline dose (whether the dose can be reduced or not), on cardiac function (whether echocardiographic data improve or worsen) and on perfusion data (whether laboratory and clinical data such as lactate, capillary refill time, mottling score or diuresis improve or worsen); * estimate what is the dose range of AVP used and what is the maximum dose used in routine clinical practice; * observe when AVP is stopped, how (abruptly or progressively); * describe the incidence of side effects of AVP, whether it is related to the dose of AVP and the comorbidities of the patients; * assess medium/long-term outcomes: 28- and 90-day mortality, ICU and hospital stay, days of vasopressor support, days of mechanical ventilation, days of renal replacement. ### Conditions Module **Conditions:** - Vasopressin Causing Adverse Effects in Therapeutic Use - Shock - Vasopressor Adverse Reaction - Vasopressin Deficiency **Keywords:** - Vasopressin - Shock ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 90 Days ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Patients treated with vasopressin **Name:** Vasopressin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Describing the time sequence of vasopressin and/or noradrenaline use (what is initiated first) during shock **Measure:** Characterise the clinical practice of vasopressin use in the context of shock in a multicentre observational study. **Time Frame:** 90 days #### Secondary Outcomes **Description:** Assess what prompted the decision to initiate AVP: type of shock (vasoplegic, hypovolemic,...), perfusion parameters (as lactate) or noradrenaline dose (microgram/kg/minute) **Measure:** Assess what prompted the decision to initiate AVP **Time Frame:** Up to 7 days **Description:** Define the impact of starting AVP on noradrenaline dose (microgram/kg/minute) **Measure:** Define the impact of starting AVP on noradrenaline dose **Time Frame:** Up to 7 days **Description:** Define the impact of starting AVP on lactate level (mmol/L) **Measure:** Define the impact of starting AVP on lactate level **Time Frame:** Up to 7 days **Description:** Describe number of participants what AVP is discontinued first and how (abruptly or progressively) **Measure:** Observe when AVP is discontinued and how **Time Frame:** Up to 7 days **Description:** Estimate the range of doses of AVP used and the maximum dose used in routine clinical practice. **Measure:** Estimate the range of doses of AVP used **Time Frame:** Up to 7 days **Description:** Describe the incidence of side effects, whether it is related to AVP dose and patients' comorbidities. **Measure:** Incidence of side effects **Time Frame:** Up to 7 days **Description:** Death on or before study day 28 **Measure:** 28-day all-cause mortality **Time Frame:** 28 days **Description:** Death on or before study day 90 **Measure:** 90-day all-cause mortality **Time Frame:** 90 days **Description:** New receipt of renal replacement therapy after onset of shock **Measure:** Incidence of new renal replacement therapy **Time Frame:** From onset of shock until hospital discharge, an average of 2 weeks **Description:** Number of days between day 28 and the end of the last period of vasopressor therapy prior to day 28 **Measure:** Vasopressor-free days to day 28 **Time Frame:** 28 days **Description:** Number of days between day 28 and the end of the last period of intensive care unit admission prior to day 28. **Measure:** Intensive care unit-free days to day 28 **Time Frame:** 28 days **Description:** Number of days between day 28 and the end of the last period of hospital admission prior to day 28 **Measure:** Hospital-free days to day 28 **Time Frame:** 28 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Any patient over 18 years of age who is in shock and requires the administration of vasoconstrictors, to whom vasopressin is administered in the operating theatre and/or critical care unit, according to best clinical practice. Exclusion Criteria: * Non-consent by patient/legal representatives **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients in shock receiving vasopressin ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Raquel García Álvarez, MD **Phone:** +34913908243 **Role:** CONTACT #### Locations **Location 1:** **City:** A Coruña **Contacts:** ***Contact 1:*** - **Name:** Pablo Rama Maceiras - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Universitario de A Coruña **Location 2:** **City:** Baracaldo **Contacts:** ***Contact 1:*** - **Name:** Gontzal Tamayo - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Universitario de Cruces **Location 3:** **City:** Barcelona **Contacts:** ***Contact 1:*** - **Name:** Marta Giné Servén - **Role:** CONTACT **Country:** Spain **Facility:** Hospital de Sant Pau **Location 4:** **City:** Barcelona **Contacts:** ***Contact 1:*** - **Name:** Ramón Adalia - **Role:** CONTACT **Country:** Spain **Facility:** Hospital del Mar **Location 5:** **City:** Barcelona **Country:** Spain **Facility:** Hospital Universitario Valle de Hebrón **Location 6:** **City:** Bilbao **Contacts:** ***Contact 1:*** - **Name:** Felipe Ortega Palacios - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Universitario de Basurto **Location 7:** **City:** Donostia **Contacts:** ***Contact 1:*** - **Name:** Cristina García Fernández - **Role:** CONTACT **Country:** Spain **Facility:** Hospital de Donostia **Location 8:** **City:** Elche **Contacts:** ***Contact 1:*** - **Name:** Ana Pérez Carbonell - **Role:** CONTACT **Country:** Spain **Facility:** Hospital General Universitario de Elche **Location 9:** **City:** Gijón **Country:** Spain **Facility:** Hospital Universitario de Cabueñes **Location 10:** **City:** León **Contacts:** ***Contact 1:*** - **Name:** Rafael González de Castro - **Role:** CONTACT **Country:** Spain **Facility:** Complejo Asistencial Universitario de León **Location 11:** **City:** Lugo **Contacts:** ***Contact 1:*** - **Name:** Lorena Mouritz - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Lucus Augustus **Location 12:** **City:** Madrid **Contacts:** ***Contact 1:*** - **Name:** Carlos Alberto Calvo García - **Role:** CONTACT **Country:** Spain **Facility:** Hospital General Universitario Gregorio Marañón **Location 13:** **City:** Madrid **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Raquel García Álvarez - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Universitario 12 de Octubre **Location 14:** **City:** Madrid **Contacts:** ***Contact 1:*** - **Name:** Fernando Ramasco Rueda - **Role:** CONTACT ***Contact 2:*** - **Name:** Jesús Nieves Alonso - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Universitario La Princesa **Location 15:** **City:** Madrid **Country:** Spain **Facility:** Hospital Universitario Ramón y Cajal **Location 16:** **City:** Majadahonda **Contacts:** ***Contact 1:*** - **Name:** Reyes Iranzo - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Universitario Puerta de Hierro Majadahonda **Location 17:** **City:** Ourense **Contacts:** ***Contact 1:*** - **Name:** Concepción Alonso - **Role:** CONTACT **Country:** Spain **Facility:** Complexo Hospitalario Universitario de Ourense **Location 18:** **City:** Oviedo **Contacts:** ***Contact 1:*** - **Name:** Beatriz Mancha Getino - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Universitario Central de Asturias **Location 19:** **City:** Santa Cruz De Tenerife **Contacts:** ***Contact 1:*** - **Name:** David Domínguez - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Universitario Nuestra Señora de Candelaria **Location 20:** **City:** Santander **Contacts:** ***Contact 1:*** - **Name:** Adriana Ixquic Reyes Echeverria - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Universitario Marqués de Valdecilla **Location 21:** **City:** Santiago De Compostela **Contacts:** ***Contact 1:*** - **Name:** Manuel Taboada - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Clínico Universitario de Santiago **Location 22:** **City:** Tarragona **Contacts:** ***Contact 1:*** - **Name:** Diego Prendes Fernández - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Universitario Joan XXIII **Location 23:** **City:** Valencia **Contacts:** ***Contact 1:*** - **Name:** Gerardo Aguilar - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Clínico Universitario de Valencia **Location 24:** **City:** Valencia **Contacts:** ***Contact 1:*** - **Name:** Miguel Ángel Rodenas - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Universitari i Politècnic La Fe #### Overall Officials **Official 1:** **Affiliation:** Hospital Universitario 12 de Octubre **Name:** Raquel García Álvarez **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Garcia-Alvarez R, Arboleda-Salazar R. Vasopressin in Sepsis and Other Shock States: State of the Art. J Pers Med. 2023 Oct 29;13(11):1548. doi: 10.3390/jpm13111548. **PMID:** 38003863 **Citation:** Treschan TA, Peters J. The vasopressin system: physiology and clinical strategies. Anesthesiology. 2006 Sep;105(3):599-612; quiz 639-40. doi: 10.1097/00000542-200609000-00026. **PMID:** 16931995 **Citation:** Dunser MW, Lindner KH, Wenzel V. A century of arginine vasopressin research leading to new therapeutic strategies. Anesthesiology. 2006 Sep;105(3):444-5. doi: 10.1097/00000542-200609000-00004. No abstract available. **PMID:** 16931974 **Citation:** Ramasco F, Nieves-Alonso J, Garcia-Villabona E, Vallejo C, Kattan E, Mendez R. Challenges in Septic Shock: From New Hemodynamics to Blood Purification Therapies. J Pers Med. 2024 Feb 3;14(2):176. doi: 10.3390/jpm14020176. **PMID:** 38392609 **Citation:** Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available. **PMID:** 34599691 **Citation:** Sharshar T, Blanchard A, Paillard M, Raphael JC, Gajdos P, Annane D. Circulating vasopressin levels in septic shock. Crit Care Med. 2003 Jun;31(6):1752-8. doi: 10.1097/01.CCM.0000063046.82359.4A. **PMID:** 12794416 **Citation:** Holmes CL, Patel BM, Russell JA, Walley KR. Physiology of vasopressin relevant to management of septic shock. Chest. 2001 Sep;120(3):989-1002. doi: 10.1378/chest.120.3.989. **PMID:** 11555538 **Citation:** Martin C, Medam S, Antonini F, Alingrin J, Haddam M, Hammad E, Meyssignac B, Vigne C, Zieleskiewicz L, Leone M. NOREPINEPHRINE: NOT TOO MUCH, TOO LONG. Shock. 2015 Oct;44(4):305-9. doi: 10.1097/SHK.0000000000000426. **PMID:** 26125087 **Citation:** Russell JA, Walley KR, Singer J, Gordon AC, Hebert PC, Cooper DJ, Holmes CL, Mehta S, Granton JT, Storms MM, Cook DJ, Presneill JJ, Ayers D; VASST Investigators. Vasopressin versus norepinephrine infusion in patients with septic shock. N Engl J Med. 2008 Feb 28;358(9):877-87. doi: 10.1056/NEJMoa067373. **PMID:** 18305265 **Citation:** Demiselle J, Fage N, Radermacher P, Asfar P. Vasopressin and its analogues in shock states: a review. Ann Intensive Care. 2020 Jan 22;10(1):9. doi: 10.1186/s13613-020-0628-2. **PMID:** 31970567 **Citation:** Gordon AC, Russell JA, Walley KR, Singer J, Ayers D, Storms MM, Holmes CL, Hebert PC, Cooper DJ, Mehta S, Granton JT, Cook DJ, Presneill JJ. The effects of vasopressin on acute kidney injury in septic shock. Intensive Care Med. 2010 Jan;36(1):83-91. doi: 10.1007/s00134-009-1687-x. Epub 2009 Oct 20. **PMID:** 19841897 **Citation:** Hamzaoui O, Goury A, Teboul JL. The Eight Unanswered and Answered Questions about the Use of Vasopressors in Septic Shock. J Clin Med. 2023 Jul 10;12(14):4589. doi: 10.3390/jcm12144589. **PMID:** 37510705 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000003919 - Term: Diabetes Insipidus - ID: D000007674 - Term: Kidney Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000010900 - Term: Pituitary Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15577 - Name: Shock - Relevance: HIGH - As Found: Shock - ID: M22545 - Name: Diabetes Insipidus, Neurogenic - Relevance: HIGH - As Found: Vasopressin Deficiency - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M7114 - Name: Diabetes Insipidus - Relevance: LOW - As Found: Unknown - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M13791 - Name: Pituitary Diseases - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: T1030 - Name: Central Diabetes Insipidus - Relevance: HIGH - As Found: Vasopressin Deficiency ### Condition Browse Module - Meshes - ID: D000020790 - Term: Diabetes Insipidus, Neurogenic - ID: D000012769 - Term: Shock ### Intervention Browse Module - Ancestors - ID: D000006490 - Term: Hemostatics - ID: D000003029 - Term: Coagulants - ID: D000014662 - Term: Vasoconstrictor Agents - ID: D000050034 - Term: Antidiuretic Agents - ID: D000045283 - Term: Natriuretic Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: NaAg - Name: Natriuretic Agents - Abbrev: VaCoAg - Name: Vasoconstrictor Agents - Abbrev: Coag - Name: Coagulants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M17414 - Name: Vasopressins - Relevance: HIGH - As Found: Oximetry - ID: M4437 - Name: Arginine Vasopressin - Relevance: HIGH - As Found: Oximetry - ID: M9576 - Name: Hemostatics - Relevance: LOW - As Found: Unknown - ID: M6259 - Name: Coagulants - Relevance: LOW - As Found: Unknown - ID: M17409 - Name: Vasoconstrictor Agents - Relevance: LOW - As Found: Unknown - ID: T1 - Name: Arginine - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000014667 - Term: Vasopressins - ID: D000001127 - Term: Arginine Vasopressin ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422962 **Brief Title:** [Trial of device that is not approved or cleared by the U.S. FDA] **Official Title:** [Trial of device that is not approved or cleared by the U.S. FDA] #### Organization Study ID Info **ID:** OTO-03 #### Organization **Full Name:** [Redacted] ### Status Module **Delayed Posting:** True #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** WITHHELD #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Name:** [Redacted] #### Responsible Party **Old Name Title:** [Redacted] **Old Organization:** [Redacted] ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422949 **Brief Title:** Efficacy and Safety of HILOTERM® Device for the Prevention of Peripheral Neuropathy **Official Title:** A Study on the Efficacy and Safety of HILOTERM® Device for the Prevention of Chemotherapy-induced Peripheral Neuropathy in Early Breast Cancer Patients #### Organization Study ID Info **ID:** IEO 1974 #### Organization **Class:** OTHER **Full Name:** European Institute of Oncology ### Status Module #### Completion Date **Date:** 2027-08-15 **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:** 2027-08-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** European Institute of Oncology #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Taxol is a very effective drug in breast cancer, but it can cause peripheral neuropathy (PN). This toxicity is often dose-limiting. Symptoms of PN usually improve after taxol discontinuation, but \>80% of affected women experience symptoms 1-3 years after treatment stop. The intensity, the duration and the type of symptoms related to PN are very different and they can strongly interfere with patients' quality of life. The application of cold to the hands and feet seems to be able to reduce the incidence of PN. Hilotherm® is a machine that allows to cool hands and feet. The aim of this study is to verify whether the use of Hilotherm® is able to reduce the incidence of moderate and severe PN and to evaluate the tolerability of Hilotherm® and its impact on quality of life. **Detailed Description:** Taxol is a very effective drug in breast cancer, but it can cause peripheral neuropathy (PN), that is damage to the nerves of the hands and feet. This toxicity can begin a few days to months after starting taxol treatment and is often dose-limiting. Symptoms of chemotherapy-induced peripheral neuropathy (CIPN) usually improve after taxol discontinuation, but \>80% of affected women experience symptoms 1-3 years after treatment stop. The intensity, the duration and the type of symptoms related to PN are very different and they range from mild and transient symptoms to more severe and persistent symptoms. These symptoms can strongly interfere with patients' quality of life and can create difficulties in carrying out activities of daily living. Despite numerous pharmacological approaches, no substance has proven capable of counteracting the onset of PN in patients eligible to receive chemotherapy with taxol. Some clinical studies have shown that the application of cold to the hands and feet is able to reduce the incidence of PN because the cold-induced constriction of the vessels leads to a reduction of blood flow and consequently to a reduced inflow of drug at the level of the hands and feet. Hilotherm® is a machine that allows to keep hands and feet at a constant temperature of 10°C. The aim of this study is to verify whether the use of Hilotherm® is able to reduce the incidence of moderate and severe PN and to evaluate the tolerability of Hilotherm® and its impact on quality of life. ### Conditions Module **Conditions:** - Breast Cancer - Neuropathy;Peripheral **Keywords:** - Early stage breast cancer - Paclitaxel - Chemotherapy-induced peripheral neuropathy ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Cooling treatment with Hilotherm® at hands and feet level **Intervention Names:** - Device: Hilotherm® Cooling treatment **Label:** Hilotherm® Cooling treatment **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Hilotherm® Cooling treatment **Description:** Patient will receive cooling treatment with Hilotherm® at hands and feet level from half an hour before taxol treatment start until half an hour after treatment end **Name:** Hilotherm® Cooling treatment **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Severity of PN evaluated using the CTCAE scale, version 5 **Measure:** Overall incidence of grade 2 or 3 CIPN **Time Frame:** 12 months #### Secondary Outcomes **Description:** Number of patients withdrawing Hilotherapy due to cold intolerance **Measure:** Incidence of withdrawal from Hilotherapy **Time Frame:** 12 weeks **Description:** Collection of EORTC QLQ-C30 \[European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire\] (minimum value: 1, maximum value: 4 - higher scores mean a worse outcome) **Measure:** Patients' physical, psychological and social functions evaluation **Time Frame:** 12 months **Description:** Collection of EORTC-BR23 \[European Organization for Research and Treatment of Cancer - Breast Cancer specific Module\] (minimum value: 1, maximum value: 4 - higher scores mean a worse outcome) **Measure:** Side effects impact evaluation **Time Frame:** 12 months **Description:** Collection of Brief Pain Inventory (BPI) questionnaire (minimum value: 0, maximum value: 10 - higher scores mean a worse outcome) **Measure:** Pain assessment **Time Frame:** 12 months **Description:** Collection of Technology Acceptance Model Questionnaire (minimum value: 1, maximum value: 7 - higher scores mean a lower agreement with the statement) **Measure:** Technology acceptance and perception evaluation **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Women \> 18 years of age * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 * Radically operated infiltrating breast cancer, pT1-T3, pN0-2, M0 * Candidate to adjuvant chemotherapy that includes weekly paclitaxel 80 mg/m2 intravenous for 12 weeks \[either following anthracyclines and/or in association with trastuzumab\] * Negative pregnancy test at baseline (in fertile women) * Willing and able to sign informed consent for protocol treatment Exclusion Criteria: * Evidence of metastatic disease (M1) * pT4 and/or pN3 * Previous or concomitant malignancy of any other type * Previous treatment with chemotherapy, hormonal therapy or an investigational drug for any type of malignancy * Plans to use a chemotherapy regimen other than those specified in the inclusion criteria * Any serious concurrent infection or any clinically significant medical illness (in particular clinically significant liver disease, clinically significant renal dysfunction, clinically significant cardiovascular disease, uncontrolled infections) which would jeopardize the ability of the patient to complete the planned therapy and follow-up * Pre-existing motor or sensory neuropathy of any grade, for any reason * Participation in any other clinical investigation or exposure to other investigational agents, drugs, device or procedure that may cause PN * History of Raynaud phenomenon, either primary or secondary to autoimmune or connective tissue diseases such as systemic lupus erythematous, scleroderma, Buerger disease, Sjögren syndrome, rheumatoid arthritis, occlusive vascular disease, such as atherosclerosis, polymyositis, cold agglutinin disease or cryoglobulinemia, thyroid disorders, pulmonary hypertension * Cold urticaria / cold contact urticaria * Severe arterial disease * Trophic tissue lesions * Diabetes mellitus * Alcohol abuse * History of severe allergic, anaphylactic, or other hypersensitivity reactions to the components of Hilotherm Chemo care device * Simultaneous use of Dignicap system to prevent hair loss from chemotherapy **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Silvia Dellapasqua, MD **Phone:** +39 0257489970 **Role:** CONTACT #### Locations **Location 1:** **City:** Milan **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Silvia Dellapasqua, MD - **Phone:** +39 0257489970 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Mara Negri - **Phone:** +39 0257489536 - **Role:** CONTACT **Country:** Italy **Facility:** European Institute of Oncology **Zip:** 20141 #### Overall Officials **Official 1:** **Affiliation:** European Istitute of Oncology **Name:** Silvia Dellapasqua, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases - ID: D000009468 - Term: Neuromuscular 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: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M13432 - Name: Peripheral Nervous System Diseases - Relevance: HIGH - As Found: Peripheral Neuropathy - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms - ID: D000010523 - Term: Peripheral Nervous System Diseases ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M19537 - Name: Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422936 **Acronym:** SPOTLIGHT204 **Brief Title:** Clinical Trial to Evaluate BO-112 in Patients With Basal Cell Carcinoma (BCC) **Official Title:** SPOTLIGHT 204: A Multicenter, Phase 2b, Open-label, Non-randomized, Clinical Trial to Evaluate Safety, Tolerability and Preliminary Efficacy of Intra-lesional BO-112 in Patients With Resectable Primary Low and High Risk Basal Cell Carcinoma #### Organization Study ID Info **ID:** BOT-112-204 #### Organization **Class:** INDUSTRY **Full Name:** Highlight Therapeutics ### Status Module #### Completion Date **Date:** 2028-06 **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:** 2026-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-27 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Highlight Therapeutics #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a multicenter, phase 2b, open-label, non-randomized, clinical trial to evaluate safety, tolerability, pharmacodynamics and preliminary efficacy of intra-lesional BO-112 in patients with resectable primary low and high risk basal cell carcinoma. * primary endpoint is complete visual and pathological response \[at surgery\] on patient level assessed by central review * secondary endpoints are 1. Occurrence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation or death on patient level. 2. Pathological response \[at surgery\] on patient level assessed by the investigator and central review, respectively, and visual response \[during the study and at surgery\] on patient level assessed by the investigator and central review, respectively. 3. Recurrence \[at 12 and 24 months\] after surgery on patient level assessed by the investigator. ### Conditions Module **Conditions:** - Basal Cell Carcinoma ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Parallel group design with same treatment and study procedures ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** patients with low risk nodular BCC **Intervention Names:** - Drug: BO-112 **Label:** Cohort I **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** patients with high risk BCC **Intervention Names:** - Drug: BO-112 **Label:** Cohort II **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Cohort I - Cohort II **Description:** Noncoding double-stranded (ds) RNA based on polyinosinic-polycytidylic acid (Poly I:C), formulated with polyethylenimine (PEI) for intra-lesional injection **Name:** BO-112 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Complete visual and pathological response of all treated BCC lesions on participant level assessed by central review **Measure:** Number of Participants with Complete Visual and Pathological Response **Time Frame:** at 24 weeks #### Secondary Outcomes **Description:** Occurrence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation or death on participant level. **Measure:** Number of Participants with Treatment-Related Adverse Events assessed by CTCAE 5.0 **Time Frame:** through study completion, average 7 months **Description:** Pathological response on participant level assessed by the investigator and central review, respectively, using a 4-point scale 1. Pathologic Complete Response (pCR): No Residual Viable Tumor (RVT) 2. Major Pathologic Response (MPR)/ "near-pCR": \<= 10% RVT 3. Pathologic Partial Response (pPR): 10% \< RVT \<= 50% " 4. Pathologic Non-Response" (pNR): \>50% RVT **Measure:** Extent of Pathological Response **Time Frame:** at 24 weeks **Description:** Visual response \[during the study and at surgery\] on participant level assessed by the investigator and central review, respectively. **Measure:** Change of Visual Lesion Appearance **Time Frame:** at baseline and at 24 weeks **Description:** Recurrence after surgery on participant level assessed by the investigator **Measure:** Number of Participants with BCC Recurrence **Time Frame:** at 12 and 24 months after surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Participant must be ≥ 18 years old \[or the legal age of consent in the jurisdiction in which the study is taking place\], at the time of signing the informed consent. Type of Participant and Disease Condition 2. Has primary resectable low or high risk basal cell carcinoma according to the protocol definition 3. Has diagnostic punch biopsy of all lesions intended for injection available prior to the first dose of BO-112. 4. Has adequate organ function defined as defined per protocol 5. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 24 hours prior to the start of study drug. 6. Women of childbearing potential must be willing to use two effective methods of birth control while treated with BO-112 and for 4 weeks after the last treatment. The two forms of birth control authorized are defined as the use of a barrier method of contraception (condom with spermicide) in association with one of the following methods of birth control: bilateral tubal ligation; combined oral contraceptives (estrogens and progesterone) or implanted or injectable contraceptives from the time of informed consent. 7. Male patients with female partners of childbearing potential must be willing to use two adequate contraception methods while treated with BO-112 and for 4 weeks after treatment completion. Informed Consent 8. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 9. Able and willing to comply with all study requirements, including surgical removal of lesion/lesion site at completion of study. Exclusion Criteria: 1. Has history of hypersensitivity to BO-112 or its excipients/vehicle. 2. Has any BCC lesion(s) in site of prior radiation and/or any BCC lesion(s) within 2 cm of the open eyelid margins 4. Has Gorlin's syndrome 5. Has clinically active or uncontrolled skin disease or tattoos that would interfere with evaluation of the area surrounding the target lesion 6. Has another malignant disease requiring treatment 7. Has a history of immunological disorder, severe allergic reaction, moderate or severe asthma or known history of anaphylaxis or any other serious adverse reactions to the investigational products. 8. Female participants: lactating or pregnant. 9. Has received a live vaccine or messenger ribonucleic acid (mRNA) Corona virus disease (COVID) vaccine within 7 days prior to the first dose of study drug or has a vaccination planned during treatment with BO-112 and within 7 days after the last study drug administration. 10. Is immunocompromised. Systemic corticosteroids at \>10 mg/day prednisone or equivalent within 1 week prior to the first dose of BO-112. 11. Has any prior systemic anti-lesion therapy or local treatment for study lesions prior to first dose; any chemotherapy or immunotherapy for any other malignancy within 24 months prior to the first dose of BO-112. 12. Has any experimental or investigational agents within one month of first BO-112 injection. 13. Has received or is expected to receive treatment with psoralen plus ultraviolet A (UVA) or ultraviolet B (UVB) therapy within 6 months prior to the first dose of BO-112. 14. Requires / or has used topical products within 5 cm of a treatment-targeted BCC lesion or systemic therapies that might interfere with the evaluation of the study medication during the study. 15. Has any other concurrent anti-cancer therapy (chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational \[used for a not approved indication and in the context of a research investigation\]) within 28 days of first study drug administration; or plans to participate in an experimental drug study while enrolled in this study. 16. Has any medical contraindications to surgery **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Marisol Quintero, PhD **Phone:** +34 682 544 814 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Zuzana Jirakova Trnkova, MD, PhD **Phone:** +34 682 544 814 **Role:** CONTACT #### Locations **Location 1:** **City:** Be'er Sheva **Contacts:** ***Contact 1:*** - **Name:** Adi Saadia, MD - **Role:** CONTACT **Country:** Israel **Facility:** Soroka Medical Center **Status:** RECRUITING **Location 2:** **City:** Haifa **Contacts:** ***Contact 1:*** - **Name:** Michal Ramon, MD - **Role:** CONTACT **Country:** Israel **Facility:** Rambam Medical Center **Status:** NOT_YET_RECRUITING **Location 3:** **City:** Jerusalem **Contacts:** ***Contact 1:*** - **Name:** Sharon Merims, MD - **Role:** CONTACT **Country:** Israel **Facility:** Hadassah Ein Kerem Medical Center **Status:** NOT_YET_RECRUITING **Location 4:** **City:** Tel Aviv **Contacts:** ***Contact 1:*** - **Name:** Gila Isman-Nelkenbaum, MD - **Role:** CONTACT **Country:** Israel **Facility:** Sourasky Medical Center **Status:** NOT_YET_RECRUITING ### 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: D000018295 - Term: Neoplasms, Basal Cell ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M5537 - Name: Carcinoma, Basal Cell - Relevance: HIGH - As Found: Basal 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: M20439 - Name: Neoplasms, Basal Cell - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000002280 - Term: Carcinoma, Basal Cell ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M13957 - Name: Poly I-C - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422923 **Brief Title:** Effect of NRTX-1001, a Cellular Therapy Product, for the Treatment of Refractory Bilateral TLE **Official Title:** A Study of Inhibitory Interneurons (NRTX-1001) for the Treatment of Drug-resistant Bilateral Temporal Lobe Focal Seizures #### Organization Study ID Info **ID:** NTE002 #### Organization **Class:** INDUSTRY **Full Name:** Neurona Therapeutics ### Status Module #### Completion Date **Date:** 2040-07-15 **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:** 2026-07-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Neurona Therapeutics #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study is designed to obtain open-label feasibility, safety, and seizure frequency data in patients with drug-resistant bilateral mesial temporal lobe epilepsy (MTLE) administered NRTX-1001. **Detailed Description:** This is an open-label study of the bilateral intrahippocampal administration of NRTX1001, with the primary endpoint to evaluate safety and a secondary endpoint to evaluate seizure metrics. ### Conditions Module **Conditions:** - Epilepsy, Temporal Lobe **Keywords:** - Bilateral Temporal Lobe Epilepsy - Bilateral MTLE - Refractory Bilateral MTLE ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This is an open-label study of the bilateral intrahippocampal administration of NRTX-1001 in a single dose cohort of up to 10 subjects. Subjects will be temporarily immunosuppressed after surgery. **Intervention Names:** - Biological: NRTX-1001 **Label:** Treatment Arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment Arm **Description:** Cellular therapy consisting of GABAergic Inhibitory Interneurons **Name:** NRTX-1001 **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Safety **Measure:** Incidence of Serious Adverse Events at end of month 12 **Time Frame:** 12 months after treatment #### Secondary Outcomes **Description:** Seizure frequency change during months 7-12, compared to frequency of clinical seizures in the 6-month baseline period. **Measure:** Change in frequency of clinical seizures **Time Frame:** 12 months after treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Male or female, age 18-75 years. 2. Subjects of childbearing potential will use highly effective contraception (defined as documented failure rate ≤1%) while taking immunosuppressants. For females using enzyme-inducing anti-seizure medications (EI-ASM), hormonal contraception will not be considered as effective (EI-ASM determined from US Prescribing Information). 3. Proven history of focal seizures of hippocampal origin with bilateral seizure foci confirmed by scalp or intracranial ictal EEG (including confirmation by recordings from responsive neurostimulation \[RNS\] electrodes when applicable). 4. Either 1. bilateral hippocampal sclerosis on MRI (evidenced by increased FLAIR signal intensity in both hippocampi or by visual assessment showing reduced volume compared to normal) or 2. bilateral temporal hypometabolism on 18-Flourodeoxyglucose Positron Emission Tomography (FDG PET) (assessed by visual assessment, comparing temporal regions to frontal/parietal lobe neocortex). In this case, ictal EEG recordings must also include intracranial confirmation. or 3. a combination of unilateral instances of the evidence described in a. and b. (e.g., one side can be evidenced by criterion a. and the other side by criterion b.) MRI or PET scans used for assessment must have been acquired within 3 years of screening. 5. For subjects with unilateral RNS, the contralateral side must meet one of the descriptions listed in inclusion criterion 4. 6. For subjects with RNS, the electrodes are in (or near) hippocampi and have been in place for ≥12 months prior to screening. 7. For subjects with RNS, the RNS device is MRI-conditional (RNS Neurostimulator model 320). Subjects with RNS® Neurostimulator, model RNS-300 devices are not eligible. Patients with other RNS model devices may be eligible depending on confirmation of MRI compatibility. 8. For subjects with RNS, RNS system batteries are not expected to need replacement during year 1 of this trial. 9. For subjects with RNS, settings for ES detection and stimulation have not changed in the past 6 months and should be held constant over the first 2 years after NRTX-1001 administration. 10. Subject has maintained a diary (written or electronic) recording clinical seizure frequency for at least 1 month prior to surgery. 11. Subject has had at least four clinical focal seizures, including at least two clinical focal seizures with objective manifestations, on average, per month for the 6 months prior to screening. 12. Subject has previously had adequate (in opinion of investigator) therapeutic trials of at least two Anti-Seizure Medicines (ASMs). 13. Current ASM regimen, and doses of other drugs known to affect seizure frequency (e.g., antidepressants), have been stable for at least three months prior to enrollment. 14. Subject has received Shingrix vaccine (first dose by at least 7 days prior to start of immunosuppression). 15. Subject can converse and read in English or Spanish. Able to participate in required study procedures and provide signed informed consent. 16. Subject has either 10th grade education or equivalent or full-scale intelligence quotient (IQ) ≥70, assessed either within 1 year of screening, or during the screening period. 17. Subject can comply with study visits \& procedures (may have caregiver assist). Exclusion Criteria: 1. Evidence of seizure focus outside hippocampus (either by seizure semiology or EEG findings). 2. MRI indicating potential malignant lesion (low-grade glioma of any type is excluded) in any location or non-malignant potentially epileptogenic lesion outside the hippocampus. Small (\<2 cm) non invasive meningioma, remote from the affected temporal lobe, is not exclusionary. 3. Seizures of non-focal origin. 4. History of status epilepticus in the year prior to screening, as guided by ILAE criteria (Trinka 2015) in the judgement of the PI. A history of cluster seizures is permitted. 5. Clinical diagnosis of autoimmune epilepsy, supported by the presence of serum antibodies detected on a standard test panel (Labcorp Autoimmune Epilepsy Evaluation Profile test 505490, or Mayo Clinic Laboratories Epilepsy, Autoimmune/Paraneoplastic Evaluation test EPS2, or similar with approval from Sponsor), either within 3 years of screening or during the baseline period. 6. Psychogenic Non-Epileptic Seizures (PNES) within the past 3 years. 7. Severe psychiatric disorders. 8. Primary or secondary immunodeficiency. 9. Evidence of active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection (symptomatic or asymptomatic as demonstrated by positive plasma polymerase chain reaction \[PCR\] or plasma Nucleic Acid Amplification Test \[NAAT\] and immunoglobulin M \[IgM\] tests). Subjects may re-screen after infection is resolved. 10. Substance use disorder (including alcohol) per the Diagnostic and Statistical Manual of Mental Illnesses (DSM-5) criteria. 11. Planned surgery within one year of enrollment. 12. Current pregnancy, or lactation. 13. Prior exposure to NRTX-1001 product, or other cell or gene therapy treatments (of any kind). 14. Participation in another investigational trial within past 30 days, excepting non-interventional studies. 15. Detection of clinically relevant donor-specific allo-HLA reactive antibodies. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Holly Finefrock, BSHS **Phone:** 650-436-3045 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Sheri Madrid, BS, BA **Phone:** 949-500-0027 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Neurona Therapeutics **Name:** John Hixson, MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000004828 - Term: Epilepsies, Partial - ID: D000073376 - Term: Epileptic Syndromes ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M7983 - Name: Epilepsy - Relevance: HIGH - As Found: Epilepsy - ID: M15452 - Name: Seizures - Relevance: LOW - As Found: Unknown - ID: M7989 - Name: Epilepsy, Temporal Lobe - Relevance: HIGH - As Found: Epilepsy, Temporal Lobe - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M7984 - Name: Epilepsies, Partial - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M1165 - Name: Epileptic Syndromes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004827 - Term: Epilepsy - ID: D000004833 - Term: Epilepsy, Temporal Lobe ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422910 **Brief Title:** Video Exercise Mobile Application for People With Knee Osteoarthritis **Official Title:** Development and Investigation of the Effectiveness of Video Exercise Mobile Application for People With Knee Osteoarthritis #### Organization Study ID Info **ID:** Tubitak diz OA #### Organization **Class:** OTHER **Full Name:** Muğla Sıtkı Koçman University ### Status Module #### Completion Date **Date:** 2024-05-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-04-30 **Type:** ACTUAL #### Start Date **Date:** 2023-05-02 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** The Scientific and Technological Research Council of Turkey #### Lead Sponsor **Class:** OTHER **Name:** Fatih Ozden #### Responsible Party **Investigator Affiliation:** Muğla Sıtkı Koçman University **Investigator Full Name:** Fatih Ozden **Investigator Title:** Assistant Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of our study is to realize an exercise training and follow-up system that individuals with knee OA can easily adapt. ### Conditions Module **Conditions:** - Telerehabilitation - Osteoarthritis, Knee ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 52 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Telerehabilitation **Label:** Intervention Group **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Other: Telerehabilitation **Label:** Control Group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Control Group - Intervention Group **Description:** Home exercises will be delivered through a video mobile application. In this application, exercises for knee osteoarthritis will be presented according to their types (stretching, strengthening, etc.). Videos deemed appropriate by the physiotherapist will be added to the exercise prescription and sent to the patients via message. Patients will have the opportunity to remotely access their own exercise prescription with visual, auditory and written commands. Translated with DeepL.com (free version) **Name:** Telerehabilitation **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** On a 0 cm straight line or numeric scale, the patient is asked to mark the pain they feel (0: no pain, 10: excruciating pain). **Measure:** Visual Analog Scale (VAS) **Time Frame:** Change from Baseline VAS at 8 weeks **Description:** WOMAC consists of 3 main headings: pain intensity, stiffness and physical function. The total score ranges from 0 (no disability) to 96 (complete disability). **Measure:** The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) **Time Frame:** Change from Baseline WOMAC at 8 weeks **Description:** On a 0 cm straight line or numeric scale, the patient will be asked to mark their pre-treatment expectation and post-treatment satisfaction level. 0 will represent the lowest expectation and satisfaction and 10 the highest expectation or satisfaction. **Measure:** Satisfaction and expectation assessment **Time Frame:** Change from Baseline Satisfaction and expectation assessment at 8 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosis of primary knee osteoarthritis (OA) according to the American College of Rheumatology (ACR) criteria * Be qualified to use the mobile application and agree to use the application Exclusion Criteria: * Individuals with poor cognitive function or inadequate reading skills * Individuals with neurological disorders that may affect mobility skills * Individuals who have undergone knee joint surgery and individuals with traumatic injuries **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Muğla **Country:** Turkey **Facility:** Fethiye State Hospital **State:** Fethiye #### Overall Officials **Official 1:** **Affiliation:** Muğla Sıtkı Koçman University **Name:** Fatih Özden, PhD **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** Muğla Sıtkı Koçman University **Name:** Baki Umut Tuğay, PhD **Role:** STUDY_DIRECTOR **Official 3:** **Affiliation:** Muğla Sıtkı Koçman University **Name:** Barış Ethem Süzek, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 4:** **Affiliation:** Sanko University **Name:** Nazan Tuğay, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 5:** **Affiliation:** Marmara University **Name:** Zübeyir Sarı, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 6:** **Affiliation:** Haliç University **Name:** İrem Çetinkaya, MSc **Role:** PRINCIPAL_INVESTIGATOR **Official 7:** **Affiliation:** İstanbul Medeniyet University **Name:** Gülser Cinbaz, MSc **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M22168 - Name: Osteoarthritis, Knee - Relevance: HIGH - As Found: Osteoarthritis, Knee - ID: M12926 - Name: Osteoarthritis - Relevance: HIGH - As Found: Osteoarthritis - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010003 - Term: Osteoarthritis - ID: D000020370 - Term: Osteoarthritis, Knee ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422897 **Acronym:** OCT **Brief Title:** Role of AS-OCT in Assessment of Corneal Perforation **Official Title:** Role of Anterior Segment Optical Coherence Tomography in Assessment of Healing of Thin or Perforated Cornea Treated by Amniotic Membrane Graft and Platelet Rich Plasma Clot #### Organization Study ID Info **ID:** 1133/04/2024 #### Organization **Class:** OTHER **Full Name:** Minia University ### Status Module #### Completion Date **Date:** 2024-06-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Minia University #### Responsible Party **Investigator Affiliation:** Minia University **Investigator Full Name:** Ahemd Abdelghany **Investigator Title:** Associate professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Assessment of healing of thin and perforated cornea after surgical treatment by anterior segment optical coherence tomography **Detailed Description:** * thin and perforated cornea (small perforation) is surgically treated by amniotic membrane graft and platelet rich plasma clot * anterior segment optical coherence tomography is performed preoperative and 1 month postoperative to assess healing ### Conditions Module **Conditions:** - Corneal Perforation ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 15 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** cases are assessed by Anterior segment optical coherence tomography 1 month after surgical managemnt **Intervention Names:** - Other: anterior segment optical coherence tomography **Label:** cases after surgical management ### Interventions #### Intervention 1 **Arm Group Labels:** - cases after surgical management **Description:** surgically treated corneal perforation by amniotic membrane graft and platelet rich plasma clot is assessed by anterior segment optical coherence tomography 1 month postoperative **Name:** anterior segment optical coherence tomography **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** complete corneal healing **Measure:** healing **Time Frame:** 1 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * thin cornea about to perforate * small corneal perforation Exclusion Criteria: * active infection **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** patients from both sexes was thin cornea or small corneal perforation surgically treated by amniotic membrane graft and platelet rich plasma clot ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ahmed A Abdelghany, professor **Phone:** 00201020009630 **Role:** CONTACT #### Locations **Location 1:** **City:** Minya **Contacts:** ***Contact 1:*** - **Name:** Ahmed Abdelghany, Ass prof - **Role:** CONTACT **Country:** Egypt **Facility:** Faculty of Medicine **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** professor **Name:** Ahmed A Abdelghany, professor **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Abdelghany AA, Bahrawy ME, Alio JL. Combined Platelet Rich Plasma and Amniotic membrane in the treatment of Perforated Corneal Ulcers. Eur J Ophthalmol. 2022 Jul;32(4):2148-2152. doi: 10.1177/11206721211049100. Epub 2021 Oct 8. **PMID:** 34623187 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000065306 - Term: Corneal Injuries - ID: D000005131 - Term: Eye Injuries - ID: D000005151 - Term: Facial Injuries - ID: D000006259 - Term: Craniocerebral Trauma - ID: D000020196 - Term: Trauma, Nervous System - ID: D000009422 - Term: Nervous System Diseases - ID: D000003316 - Term: Corneal Diseases - ID: D000005128 - Term: Eye Diseases - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC11 - Name: Eye 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: M28724 - Name: Corneal Perforation - Relevance: HIGH - As Found: Corneal Perforation - ID: M6539 - Name: Corneal Diseases - Relevance: LOW - As Found: Unknown - ID: M30499 - Name: Corneal Injuries - Relevance: LOW - As Found: Unknown - ID: M8274 - Name: Eye Injuries - Relevance: LOW - As Found: Unknown - ID: M21089 - Name: Facies - Relevance: LOW - As Found: Unknown - ID: M8294 - Name: Facial Injuries - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M9349 - Name: Craniocerebral Trauma - Relevance: LOW - As Found: Unknown - ID: M22023 - Name: Trauma, Nervous System - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000057112 - Term: Corneal Perforation ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422884 **Brief Title:** A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial) **Official Title:** A Phase 2, Multi-Center, Randomized, Double-Blind, Controlled Trial Evaluating the Safety and Efficacy of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial) #### Organization Study ID Info **ID:** ENV-IPF-103 #### Organization **Class:** INDUSTRY **Full Name:** Endeavor Biomedicines, Inc. ### Status Module #### Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-09 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Endeavor Biomedicines, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this clinical trial is to evaluate the impact that ENV-101 has on lung function and key measures of fibrosis in adult patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). Another goal of this study is to better understand the safety and tolerability of ENV-101 in these patient populations. **Detailed Description:** This trial is a 6-month, randomized, double-blind, controlled, dose-ranging trial of ENV-101 in two parallel cohorts of adult patients with lung fibrosis: idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). Patients are allowed to continue treatment with approved standard of care (e.g., nintedanib, pirfenidone) during the trial. Patients will be randomized to one of 3 dose levels of ENV-101 or placebo at baseline. The objectives of this trial are to characterize the efficacy, antifibrotic activity, and safety of ENV-101 to select the Phase 3 dose of ENV-101 in each indication. ### Conditions Module **Conditions:** - Idiopathic Pulmonary Fibrosis - Progressive Pulmonary Fibrosis - Progressive Fibrosing Interstitial Lung Disease ### 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:** 320 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: ENV-101 **Label:** ENV-101 Low Dose (IPF Population) **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: ENV-101 **Label:** ENV-101 Mid Dose (IPF Population) **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Drug: ENV-101 **Label:** ENV-101 High Dose (IPF Population) **Type:** EXPERIMENTAL #### Arm Group 4 **Intervention Names:** - Drug: Placebo **Label:** Placebo (IPF Population) **Type:** PLACEBO_COMPARATOR #### Arm Group 5 **Intervention Names:** - Drug: ENV-101 **Label:** ENV-101 Low Dose (PPF Population) **Type:** EXPERIMENTAL #### Arm Group 6 **Intervention Names:** - Drug: ENV-101 **Label:** ENV-101 Mid Dose (PPF Population) **Type:** EXPERIMENTAL #### Arm Group 7 **Intervention Names:** - Drug: ENV-101 **Label:** ENV-101 High Dose (PPF Population) **Type:** EXPERIMENTAL #### Arm Group 8 **Intervention Names:** - Drug: Placebo **Label:** Placebo (PPF Population) **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - ENV-101 High Dose (IPF Population) - ENV-101 High Dose (PPF Population) - ENV-101 Low Dose (IPF Population) - ENV-101 Low Dose (PPF Population) - ENV-101 Mid Dose (IPF Population) - ENV-101 Mid Dose (PPF Population) **Description:** oral tablet, dosed once a day **Name:** ENV-101 **Other Names:** - taladegib **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo (IPF Population) - Placebo (PPF Population) **Description:** oral tablet, dosed once a day **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** ppFVC is a measure of lung function **Measure:** IPF Population Primary Endpoint: Rate of change in percent predicted forced vital capacity (ppFVC) compared to placebo **Time Frame:** Baseline and Week 24 **Description:** The incidence, severity, and relationship of treatment-emergent adverse events (TEAEs), and treatment-emergent and clinically significant changes in lab parameters, vital signs, electrocardiogram (ECG), and oxygen saturation **Measure:** PPF Population Primary Endpoint: Safety **Time Frame:** Baseline and Week 24 #### Secondary Outcomes **Measure:** PPF Population: Rate of change in ppFVC compared to placebo **Time Frame:** Baseline and Week 24 **Description:** FVC is a measure of lung function **Measure:** Absolute change in FVC (mL) compared to placebo **Time Frame:** Baseline and Week 24 **Measure:** Time to disease progression (absolute decline in ppFVC >10%, IPF-related hospitalization, or death) compared to placebo **Time Frame:** Baseline and Week 24 **Description:** The L-PF Symptoms Questionnaire Cough domain consists of 6 questions regarding a subject's experience with cough over the prior 24 hours. Questions have response options on a five-point numeric rating scale with an anchor of 0 ("Not at all") to 4 ("Extremely"). Total score for the Cough domain is normalized to the range 0 to 100, with higher scores indicating greater impairment. **Measure:** Absolute change in the Living with Pulmonary Fibrosis Symptoms (L-PF Symptoms) Questionnaire Cough domain score compared to placebo **Time Frame:** Baseline and Week 24 **Description:** The L-PF Symptoms Questionnaire Dyspnea domain consists of 12 questions regarding a subject's experience with dyspnea (shortness of breath) over the prior 24 hours. Questions have response options on a five-point numeric rating scale with an anchor of 0 ("Not at all") to 4 ("Extremely"). Total score for the Dyspnea domain is normalized to the range 0 to 100, with higher scores indicating greater impairment. **Measure:** Absolute change in the L-PF Symptoms Questionnaire Dyspnea domain score compared to placebo **Time Frame:** Baseline and Week 24 **Description:** The L-PF Symptoms Questionnaire Fatigue domain consists of 5 questions regarding a subject's experience with fatigue over the prior 24 hours. Questions have response options on a five-point numeric rating scale with an anchor of 0 ("Not at all") to 4 ("Extremely"). Total score for the Fatigue domain is normalized to the range 0 to 100, with higher scores indicating greater impairment. **Measure:** Absolute change in the L-PF Symptoms Questionnaire Fatigue domain score compared to placebo **Time Frame:** Baseline and Week 24 **Description:** HRCT is a method of imaging which is more precise than chest x-ray in the diagnosis and monitoring of diseases of the lung tissue and the airways. **Measure:** Absolute change in total lung capacity (TLC) by chest high-resolution computed tomography (HRCT) imaging compared to placebo **Time Frame:** Baseline and Week 24 **Measure:** Absolute change in % quantitative interstitial lung disease (QILD) by chest HRCT imaging compared to placebo compared to placebo **Time Frame:** Baseline and Week 24 **Measure:** Absolute change in % quantitative ground glass opacity (QGG) by chest HRCT imaging compared to placebo **Time Frame:** Baseline and Week 24 **Measure:** Absolute change in % quantitative lung fibrosis (QLF) by chest HRCT imaging compared to placebo **Time Frame:** Baseline and Week 24 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * IPF Population: Patients ≥ 40 years old with an IPF diagnosis as confirmed by the Investigator. * PPF Population: Patients ≥ 18 years old (or the minimum legal adult age, whichever is greater) with a diagnosis of PPF, as confirmed by the Investigator. * Percent predicted FVC of ≥ 45% at study start. * Percent predicted diffusing capacity of lung for carbon monoxide (DLCO) ≥ 25%, adjusted for hemoglobin (Hgb) at study start. * Ability to perform spirometry tests. * Either stable treatment with standard of care (SoC) \[i.e., antifibrotics, immunosuppressants (PPF only)\] for at least 3 months prior to study start or not treated with SoC for at least 8 weeks prior to study start. Exclusion Criteria: * IPF Population: Evidence of other known causes of interstitial lung disease (ILD) * Forced expiratory volume in one second (FEV1)/FVC ratio \<0.7 at study start. * History of malignancy, including carcinoma during the preceding 5 years from study start, with the following exceptions: 1. Prior history of in situ melanoma, basal or squamous cell skin cancer if treated with curative therapy. 2. Patients with prostate cancer that are managed by surveillance. 3. Patients with ductal carcinoma in situ, treated surgically with curative intent. * Patients with moderate to severe hepatic impairment (Child-Pugh B and C). * Smoking (including vaping) within 6 months of study start; current smoker, or unwillingness to refrain from smoking during the clinical trial duration. * Active or suspected alcohol or drug abuse in the opinion of the Investigator. * Currently enrolled in another investigational device or drug trial, or less than 3 months from study start since ending another investigational device or drug trial(s) or receiving other investigational treatment(s). * Presence of active infection at study start or confirmed active human immunodeficiency virus (HIV), Hepatitis B virus (HBV) or Hepatitis C virus (HCV). * Major surgery requiring hospitalization (according to the Investigator) performed within 3 months prior to study start or planned during the course of the trial. Being on a transplant list is allowed. * Occurrence of serious illness requiring hospitalization within 90 days prior to study start. * Current or previous use (within 28 days prior to study start) of the following: 1. Endothelin receptor antagonist 2. Riociguat 3. Prostacyclin or prostacyclin analogue 4. Radiation to the lungs 5. Oral corticosteroids \>15 mg/day * Use of cyclophosphamide or tocilizumab within 8 weeks, or rituximab within 6 months, prior to study start. * Use of drugs that are known moderate or stronger CYP3A4 inhibitors or inducers within 14 days prior to study start. Patients must also agree not to eat fruits that inhibit CYP3A4 such as grapefruit, Seville oranges, pomelo and star fruit. * Patients of reproductive potential who are sexually active and unwilling to use birth control for the duration of the study and for 3 months after their final dose of study drug. * Females that are pregnant or nursing. * Patients that are unwilling to refrain from blood or blood product donation for the duration of the study and for 30 days after their final dose of study drug. * Males who are unwilling to refrain from sperm donation and females who are unwilling to refrain from egg donation for the duration of the study and for 3 months after their final dose of study drug. * Patients with a history of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of ENV-101. * Patients who have previously taken ENV-101. **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Endeavor Clinical Trials **Phone:** 1-858-727-3199 **Role:** CONTACT #### Locations **Location 1:** **City:** Birmingham **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 858-727-3199 - **Role:** CONTACT **Country:** United States **Facility:** Research Site **State:** Alabama **Zip:** 35233 **Location 2:** **City:** Phoenix **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 858-727-3199 - **Role:** CONTACT **Country:** United States **Facility:** Research Site **State:** Arizona **Zip:** 85013 **Location 3:** **City:** Gainesville **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 858-727-3199 - **Role:** CONTACT **Country:** United States **Facility:** Research Site **State:** Florida **Zip:** 32608 **Location 4:** **City:** Maywood **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 858-727-3199 - **Role:** CONTACT **Country:** United States **Facility:** Research Site **State:** Illinois **Zip:** 60153 **Location 5:** **City:** Kansas City **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 858-727-3199 - **Role:** CONTACT **Country:** United States **Facility:** Research Site **State:** Kansas **Zip:** 66160 **Location 6:** **City:** Ann Arbor **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 858-727-3199 - **Role:** CONTACT **Country:** United States **Facility:** Research Site **State:** Michigan **Zip:** 48109 **Location 7:** **City:** Royal Oak **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 858-727-3199 - **Role:** CONTACT **Country:** United States **Facility:** Research Site **State:** Michigan **Zip:** 48073 **Location 8:** **City:** Portland **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Studies - **Phone:** 858-727-3199 - **Role:** CONTACT **Country:** United States **Facility:** Research Site **State:** Oregon **Zip:** 97220 **Location 9:** **City:** Philadelphia **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 858-727-3199 - **Role:** CONTACT **Country:** United States **Facility:** Research Site **State:** Pennsylvania **Zip:** 19107 **Location 10:** **City:** Philadelphia **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 858-727-3199 - **Role:** CONTACT **Country:** United States **Facility:** Research Site **State:** Pennsylvania **Zip:** 19140 **Location 11:** **City:** Dallas **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 858-727-3199 - **Role:** CONTACT **Country:** United States **Facility:** Research Site **State:** Texas **Zip:** 75246 **Location 12:** **City:** San Antonio **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 858-727-3199 - **Role:** CONTACT **Country:** United States **Facility:** Research Site **State:** Texas **Zip:** 78229 **Location 13:** **City:** South Brisbane **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** Australia **Facility:** Research Site **State:** Queensland **Zip:** 4101 **Location 14:** **City:** Adelaide **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** Australia **Facility:** Research Site **State:** South Australia **Zip:** 5000 **Location 15:** **City:** Box Hill **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** Australia **Facility:** Research Site **State:** Victoria **Zip:** 3128 **Location 16:** **City:** Melbourne **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** Australia **Facility:** Research Site **State:** Victoria **Zip:** 3004 **Location 17:** **City:** Nedlands **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** Australia **Facility:** Research Site **State:** Western Australia **Zip:** 6009 **Location 18:** **City:** Vienna **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** Austria **Facility:** Research Site **Zip:** 1090 **Location 19:** **City:** Vancouver **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** Canada **Facility:** Research Site **State:** British Columbia **Zip:** V6Z 2K5 **Location 20:** **City:** Sherbrooke **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** Canada **Facility:** Research Site **State:** Quebec **Zip:** J1H 5N4 **Location 21:** **City:** Munich **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** Germany **Facility:** Research Site **Zip:** 81377 **Location 22:** **City:** Dublin **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** Ireland **Facility:** Research Site **Zip:** D04 T6F4 **Location 23:** **City:** Ulsan **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** Korea, Republic of **Facility:** Research Site **State:** (Dong District) **Zip:** 44033 **Location 24:** **City:** Seoul **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** Korea, Republic of **Facility:** Research Site **State:** (Gangnam District) **Zip:** 135-710 **Location 25:** **City:** Busan **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** Korea, Republic of **Facility:** Research Site **State:** (Haeundae District) **Location 26:** **City:** Seoul **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** Korea, Republic of **Facility:** Research Site **State:** (Seongbuk District) **Zip:** 02841 **Location 27:** **City:** Seoul **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** Korea, Republic of **Facility:** Research Site **State:** (Songpa District) **Zip:** 05505 **Location 28:** **City:** Seoul **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** Korea, Republic of **Facility:** Research Site **State:** (Yongsan District) **Zip:** 04401 **Location 29:** **City:** Kuala Lumpur **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** Malaysia **Facility:** Research Site **Zip:** 50590 **Location 30:** **City:** Selayang Baru Utara **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** Malaysia **Facility:** Research Site **Location 31:** **City:** Monterrey **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** Mexico **Facility:** Research Site **State:** Nuevo Leon **Zip:** 64060 **Location 32:** **City:** Monterrey **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** Mexico **Facility:** Research Site **State:** Nuevo Leon **Zip:** 64718 **Location 33:** **City:** San Nicolás De Los Garza **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** Mexico **Facility:** Research Site **State:** Nuevo Leon **Zip:** 66465 **Location 34:** **City:** San Juan Del Río **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** Mexico **Facility:** Research Site **State:** Queretaro **Zip:** 76800 **Location 35:** **City:** Chihuahua **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** Mexico **Facility:** Research Site **Zip:** 31203 **Location 36:** **City:** Mexico City **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** Mexico **Facility:** Research Site **Zip:** 14080 **Location 37:** **City:** Oaxaca **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** Mexico **Facility:** Research Site **Zip:** 68000 **Location 38:** **City:** Puebla **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** Mexico **Facility:** Research Site **Zip:** 72180 **Location 39:** **City:** Bern **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** Switzerland **Facility:** Research Site **Zip:** 3010 **Location 40:** **City:** Edinburgh **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** United Kingdom **Facility:** Research Site **Zip:** EH1 3EG **Location 41:** **City:** Exeter **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** United Kingdom **Facility:** Research Site **Zip:** EX2 5DW **Location 42:** **City:** London **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Endeavor Clinical Trials - **Phone:** 1-858-727-3199 - **Role:** CONTACT **Country:** United Kingdom **Facility:** Research Site **Zip:** SW3 6NP #### Overall Officials **Official 1:** **Affiliation:** Endeavor Biomedicines **Name:** Paul Frohna, M.D., Ph.D., Pharm.D. **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14512 - Name: Pulmonary Fibrosis - Relevance: HIGH - As Found: Pulmonary Fibrosis - ID: M27989 - Name: Idiopathic Pulmonary Fibrosis - Relevance: HIGH - As Found: Idiopathic Pulmonary Fibrosis - ID: M8485 - Name: Fibrosis - Relevance: HIGH - As Found: Fibrosis - ID: M11168 - Name: Lung Diseases - Relevance: HIGH - As Found: Lung Disease - ID: M19813 - Name: Lung Diseases, Interstitial - Relevance: HIGH - As Found: Interstitial Lung Disease - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: T3003 - Name: Idiopathic Pulmonary Fibrosis - Relevance: HIGH - As Found: Idiopathic Pulmonary Fibrosis ### Condition Browse Module - Meshes - ID: D000008171 - Term: Lung Diseases - ID: D000011658 - Term: Pulmonary Fibrosis - ID: D000054990 - Term: Idiopathic Pulmonary Fibrosis - ID: D000017563 - Term: Lung Diseases, Interstitial - ID: D000005355 - Term: Fibrosis ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422871 **Acronym:** PReSeRVE-HD **Brief Title:** Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis **Official Title:** PReSeRVE-HD: PRospective, Multicenter, Observational Study of the Merit HeRO® Graft and Super HeRO® EValuated in End-Stage Renal Disease Patients on HemoDialysis #### Organization Study ID Info **ID:** CVO-P4-23-02 #### Organization **Class:** INDUSTRY **Full Name:** Merit Medical Systems, Inc. ### Status Module #### Completion Date **Date:** 2028-07-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-01-15 **Type:** ESTIMATED #### Start Date **Date:** 2025-02-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Merit Medical Systems, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this observational study is to increase the understanding of the safety and performance of Merit Medical's HeRO Graft System (HeRO) and Super HeRO Adaptor and Support Seal System (Super HeRO) devices. This study includes adults that are being treated with one of these devices as part of their regular medical care for maintaining long-term dialysis access when all other dialysis access options have failed. Patients in the study will return to their study center 4 times over 2 years for follow-up visits to check their current health and dialysis status. ### Conditions Module **Conditions:** - End Stage Renal Disease - Hemodialysis Access Failure ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 175 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects who meet all inclusion criteria and none of the exclusion criteria and treatment is attempted with the HeRO® Graft or Super HeRO® device. **Intervention Names:** - Device: HeRO® Graft System or Super HeRO® System **Label:** HeRO® / Super HeRO® ### Interventions #### Intervention 1 **Arm Group Labels:** - HeRO® / Super HeRO® **Description:** Treatment attempted with the HeRO® or Super HeRO® device. **Name:** HeRO® Graft System or Super HeRO® System **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Proportion of subjects with cumulative patency **Measure:** Effectiveness Endpoint **Time Frame:** 6 months **Description:** Proportion of subjects with device-related infection-free survival **Measure:** Safety Endpoint **Time Frame:** 6 months #### Secondary Outcomes **Measure:** Proportion of subjects with primary patency **Time Frame:** 12 and 24 months **Measure:** Proportion of subjects with cumulative patency **Time Frame:** 12 and 24 months **Measure:** Device-related safety events **Time Frame:** 24 months ### Eligibility Module **Eligibility Criteria:** Key Inclusion Criteria: * Subject provides written informed consent * Subject is ≥ 18 years * Subject is end-stage renal disease patient on hemodialysis. * Subject is treated with HeRO Graft or Super HeRO System in accordance with device instructions for use (IFU) Key Exclusion Criteria: * Subject has a previously placed HeRO or Super HeRO device that is undergoing revision or replacement * Subject has a topical or subcutaneous infection associated with the implantation site * Subject has known or suspected systemic infection, bacteremia or septicemia **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** End-stage renal disease patients on hemodialysis who have exhausted all other access options. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** PReSeRVE-HD Clinical Affairs Team **Phone:** 978-758-6166 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Baylor Scott and White Health **Name:** Stephen Hohmann, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000051436 - Term: Renal Insufficiency, Chronic - ID: D000051437 - Term: Renal Insufficiency - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### 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: Renal Disease - ID: M10699 - Name: Kidney Failure, Chronic - Relevance: HIGH - As Found: End Stage Renal Disease - ID: M26718 - Name: Renal Insufficiency - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M26717 - Name: Renal Insufficiency, Chronic - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007674 - Term: Kidney Diseases - ID: D000007676 - Term: Kidney Failure, Chronic ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422858 **Acronym:** Stars **Brief Title:** Sequential Tegafur-gimeracil-oteracil Potassium Capsule (s-1) and Serplulimab Following Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma **Official Title:** Sequential Tegafur-gimeracil-oteracil Potassium Capsule (s-1) and Serplulimab Following Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Inoperable Esophageal Squamous Cell Carcinoma: A Single-Arm Phase II Clinical Trial #### Organization Study ID Info **ID:** STARS-CCRT-ESCC #### Organization **Class:** OTHER **Full Name:** Zhejiang Cancer Hospital ### Status Module #### Completion Date **Date:** 2026-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-04 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Zhejiang Cancer Hospital #### Responsible Party **Investigator Affiliation:** Zhejiang Cancer Hospital **Investigator Full Name:** Ji Yongling **Investigator Title:** Dr **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This Phase II trial evaluates the efficacy and safety of Serplulimab combined with S1 chemotherapy in patients with inoperable, locally advanced esophageal squamous cell carcinoma after concurrent chemoradiation. The primary endpoint is the one-year progression-free survival rate. Secondary measures include clinical response rates, overall survival, duration of response, and safety profiles. Exploratory goals focus on the potential of biomarkers like PD-L1 and ctDNA to predict treatment outcomes. Treatment involves initial chemoradiation followed by consolidation with Serplulimab and S1, continuing for up to 12 months or until disease progression or unacceptable toxicity. **Detailed Description:** Detailed Description: This single-arm, Phase II study is designed to assess the efficacy and safety of the combination of Serplulimab (an anti-PD-1 antibody) and S1 (an oral fluoropyrimidine derivative) in patients with locally advanced, inoperable esophageal squamous cell carcinoma (ESCC), following concurrent chemoradiation therapy. Study Treatment Regimen: Patients enrolled in the study will first undergo concurrent chemoradiation, which includes a total radiation dose of 50.4 Gy delivered in 28 fractions over six weeks. Radiation will be administered using modern techniques such as image-guided radiation therapy (IGRT), intensity-modulated radiation therapy (IMRT), volumetric modulated arc therapy (VMAT), or helical tomotherapy (TOMO), ensuring precise targeting of the tumor and surrounding lymph nodes. Concurrent chemotherapy consists of cisplatin (75 mg/m2 on day 1) and S1 (60 mg/m2 per day, given in two divided doses from day 1 to day 14, repeated every 28 days). Following chemoradiation, patients will receive consolidation therapy with Serplulimab administered at a fixed dose of 300 mg every three weeks via intravenous infusion, alongside S1 (60 mg/m2 per day, on days 1-14 of a 21-day cycle). This consolidation phase will continue for up to 12 months or 17 cycles, unless there is disease progression, patient withdrawal, onset of unacceptable toxicity, or initiation of new anti-cancer treatment. ### Conditions Module **Conditions:** - Locally Advanced Inoperable Esophageal Squamous Cell Carcinoma ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 37 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Serplulimab - Drug: Tegafur-gimeracil-oteracil potassium capsule(S1) - Radiation: Radiotherapy - Drug: Cisplatin **Label:** Serplulimab and S1 Chemotherapy Post-Concurrent Chemoradiation **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Serplulimab and S1 Chemotherapy Post-Concurrent Chemoradiation **Description:** Serplulimab will be administered as a fixed dose of 300 mg via intravenous infusion every three weeks, continuing for up to 12 months or until disease progression, unacceptable toxicity, or withdrawal of consent **Name:** Serplulimab **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Serplulimab and S1 Chemotherapy Post-Concurrent Chemoradiation **Description:** S1 will be administered at a dose of 60 mg/m2 per day, taken orally in two divided doses on day 1 concurrent with radiotherapy, repeated every 28 days; and from day 1 to day 14 of each 21-day cycle, for up to 12 months or until disease progression, unacceptable toxicity, or withdrawal of consent **Name:** Tegafur-gimeracil-oteracil potassium capsule(S1) **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Serplulimab and S1 Chemotherapy Post-Concurrent Chemoradiation **Description:** Radiotherapy will be delivered as a total dose of 50.4 Gy in 28 fractions over six weeks using techniques such as IGRT, IMRT, VMAT, or TOMO, targeting the primary tumor and associated lymph nodes **Name:** Radiotherapy **Type:** RADIATION #### Intervention 4 **Arm Group Labels:** - Serplulimab and S1 Chemotherapy Post-Concurrent Chemoradiation **Description:** Cisplatin will be administered at a dose of 75 mg/m\^2 on day 1 concurrent with radiotherapy, repeated every 28 days **Name:** Cisplatin **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** The study will implement a pre-specified safety threshold where if the incidence of Grade 3 pneumonia, as categorized by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), exceeds 15% of participants, the trial may be modified or halted to assess and mitigate risks to patient safety. **Measure:** Grade 3 Pneumonia Incidence [Safety and Tolerability] **Time Frame:** through study completion, an average of 1 year #### Primary Outcomes **Description:** The primary outcome measure is the proportion of participants who are alive and free from disease progression at one year after initiating treatment. Progression is defined according to RECIST v1.1 criteria as a 20% increase in the sum of diameters of target lesions, the appearance of new lesions, or the worsening of non-target disease **Measure:** One-Year Progression-Free Survival (PFS) **Time Frame:** 1 year #### Secondary Outcomes **Description:** The rate of participants achieving a clinical complete response assessed by RECIST v1.1 criteria. A clinical complete response is defined as the disappearance of all target lesions and normalization of tumor marker levels. **Measure:** Incidence of Clinical Complete Response Rate (cCR) at 3 months after treatment initiation **Time Frame:** Assessed at 3 months after treatment initiation **Description:** Overall survival is defined as the time from the start of treatment to the date of death from any cause. If a patient is not known to have died, survival time will be censored at the date of the last known follow-up. **Measure:** Overall Survival (OS) **Time Frame:** From the start of treatment up to 3 years **Description:** Duration of response is measured from the time measurement criteria are first met for Complete Response or Partial Response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. **Measure:** Duration of Response (DoR) **Time Frame:** From the first documented response up to 2 years **Description:** The incidence and severity of adverse events categorized by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. **Measure:** Incidence of Treatment-Emergent Adverse Events **Time Frame:** Throughout the study, estimated at 12 months **Description:** Qualitasured using validated instruments such as the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30). The quality of life score is calculated based on the rules set by EORTC (range 0-100). A lower score indicates better quality of life on the symptom scales, while a higher score indicates better quality of life scores on the overall health and functional scales. **Measure:** EORTC-QoL-C30 Score(Quality of Life) **Time Frame:** At baseline, 6 months, and 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Able to understand and voluntarily sign a written informed consent form, which must be signed before initiating any study-specific procedures. * Male or female participants aged between 18 and 70 years at the time of informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Histologically or cytologically confirmed diagnosis of locally advanced esophageal squamous cell carcinoma (ESCC); or patients who refuse surgery; staged as T1-4bN1-3M0 (according to AJCC 8th edition). * Medically inoperable or refusal of surgery. * No prior anti-tumor treatment. * Expected survival of at least 6 months. * At least one measurable lesion as defined by RECIST v1.1. * Participants must provide either archived (within the last 2 years) or freshly obtained tumor tissue samples, with at least three unstained FFPE pathology slides. * Adequate organ function defined as follows: a. Hematology (no blood transfusions or growth factor support within 7 days before starting study treatment): i. Absolute Neutrophil Count (ANC) ≥1.5×10\^9/L (1500/mm³); ii. Platelet count ≥100×10\^9/L (100000/mm³); iii. Hemoglobin ≥90 g/L. b. Renal: i. Calculated creatinine clearance (CrCl) ≥50 mL/min using the Cockcroft-Gault formula: CrCl (mL/min) = {(140-age) × weight (kg) × F} / (SCr (mg/dL) × 72), where F=1 for males and 0.85 for females; SCr=serum creatinine. ii. Urinary protein \<2+ or 24-hour urinary protein quantification \<1.0 g. c. Liver: i. Total bilirubin (TBiL) ≤1.5×ULN; ii. AST and ALT ≤2.5×ULN (≤5×ULN for participants with liver metastases); iii. Serum albumin (ALB) ≥28 g/L. d. Coagulation: International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN, unless the participant is receiving anticoagulant therapy and INR and APTT are within the expected range of their therapeutic use. e. Cardiac: Left Ventricular Ejection Fraction (LVEF) ≥50%. * Female participants of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose of study medication. If urine test is not conclusive, a serum test will be administered. If sexually active with a non-sterilized male partner, the participant must agree to use effective contraception during the study and for 120 days after the last dose of study medication. Discussion with the researcher is required regarding cessation of contraception after this point. * Male participants with female partners of childbearing potential must agree to use effective contraception from screening to 120 days after the last dose of study medication. Discussion with the researcher is required regarding cessation of contraception after this point. * Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: * Previous anti-tumor treatment (including chemotherapy, radiation therapy, surgery, or immunotherapy). * Initial diagnosis with metastases to vital organs such as the liver, bones, lungs, brain, adrenal glands, etc. (stage IVb esophageal cancer). * History of thoracic radiotherapy. * Presence of an esophageal mediastinal fistula and/or esophageal tracheal fistula before treatment. * Known or suspected allergy to any component of S1, serplulimab, or cisplatin. * Pregnant or breastfeeding women. * Inability to provide informed consent due to psychological, familial, or social reasons. * History of any malignancy other than esophageal cancer within the past 5 years, except for adequately treated non-melanoma skin cancer, in-situ cervical cancer, or cured early-stage prostate cancer. * Unable to tolerate chemoradiation due to severe cardiac, pulmonary, hepatic, renal dysfunctions, hematological diseases, or cachexia. * Active autoimmune diseases, history of autoimmune diseases (including but not limited to colitis, hepatitis, hyperthyroidism, or syndromes), history of immunodeficiency (including positive HIV test), or other acquired or congenital immunodeficiency diseases, history of organ transplant or allogeneic bone marrow transplant. * Active hepatitis B (HBV DNA ≥ 2000IU/mL or 10×10\^4 copies/mL), positive hepatitis C antibody with elevated HCV RNA levels above the lower limit of detection. History of immunodeficiency; positive HIV antibody; current long-term use of systemic corticosteroids or other immunosuppressants. * Serious infection within 4 weeks before the first administration of study medication, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective treatment within 2 weeks before the first dose (excluding antiviral treatment for hepatitis B or C). Known active tuberculosis (TB), suspected active TB requiring clinical exclusion; known active syphilis infection. * Vaccination with live or attenuated live vaccines within 30 days before the first dose of study medication or planning to receive such vaccines during the study period; inactivated vaccines are permitted. * History of interstitial lung disease or non-infectious pneumonia. * History of myocarditis, cardiomyopathy, malignant arrhythmias, unstable angina, myocardial infarction within the past 12 months, congestive heart failure as determined by NYHA Class II or higher, or vascular diseases such as aortic aneurysm at risk of rupture, or other cardiac damage that could compromise the safety evaluation of the study medication (such as poorly controlled arrhythmia or myocardial ischemia). * Known history of mental illness, drug abuse, alcoholism, or drug addiction. * Non-malignant systemic diseases or symptoms secondary to tumors that could pose a higher medical risk or confound the assessment of survival, such as leukemic reaction (white cell count \>20×10\^9/L) or cachexia manifestations (known weight loss exceeding 10% in the 3 months prior to screening). * Any condition that, in the opinion of the investigator, might pose a risk to the participant, interfere with the evaluation of the study medication, or confound the interpretation of study results. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jin Wang, Dr **Phone:** 86-571-88122564 **Role:** CONTACT #### Locations **Location 1:** **City:** Hangzhou **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jin Wang, MD - **Phone:** 0086-571-88122088 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Yongling JI, MD - **Phone:** 0086-571-88122088 - **Role:** CONTACT ***Contact 3:*** - **Name:** Yongling JI, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** Zhejiang Cancer Hospital **State:** Zhejiang **Status:** RECRUITING **Zip:** 310022 #### Overall Officials **Official 1:** **Affiliation:** Zhejiang Cancer Hospital **Name:** Yongling Ji **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: D000018307 - Term: Neoplasms, Squamous Cell - ID: D000004938 - Term: Esophageal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000004935 - Term: Esophageal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M5550 - Name: Carcinoma, Squamous Cell - Relevance: HIGH - As Found: Squamous Cell Carcinoma - ID: M1733 - Name: Esophageal Squamous Cell Carcinoma - Relevance: HIGH - As Found: Esophageal Squamous Cell Carcinoma - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M20451 - Name: Neoplasms, Squamous Cell - Relevance: LOW - As Found: Unknown - ID: M8088 - Name: Esophageal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8085 - Name: Esophageal Diseases - Relevance: LOW - As Found: Unknown - ID: T2141 - Name: Esophageal Cancer - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000002294 - Term: Carcinoma, Squamous Cell - ID: D000077277 - Term: Esophageal Squamous Cell Carcinoma ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M6182 - Name: Cisplatin - Relevance: LOW - As Found: Unknown - ID: M8760 - Name: Tegafur - Relevance: HIGH - As Found: Nail - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000005641 - Term: Tegafur ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422845 **Acronym:** SCDB **Brief Title:** Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis **Official Title:** A Prospective, Multicenter, Single-Arm Target Value Clinical Study to Evaluate the Safety and Effectiveness of Peripheral Scoring Drug-coated Balloon Dilation Catheter in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis #### Organization Study ID Info **ID:** VP-P-24-012 #### Organization **Class:** INDUSTRY **Full Name:** DK Medical Technology (Suzhou) Co., Ltd. ### Status Module #### Completion Date **Date:** 2027-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** DK Medical Technology (Suzhou) 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 prospective, multi-center, single-arm target value clinical study to study the safety and effectiveness of Peripheral Scoring Drug-coated Balloon dilatation catheters in the treatment of hemodialysis arteriovenous fistula stenosis. **Detailed Description:** This is a prospective, multi-center, single-arm target value clinical study to study the safety and effectiveness of Peripheral Scoring Drug-coated Balloon dilatation catheters (SDCB) in the treatment of hemodialysis arteriovenous fistula stenosis. A total of 328 participants will be enrolled across multiple clinical trial sites. Participants will undergo a surgical procedure using a peripheral scoring drug-coated balloon dilation catheter, with follow-up within 5 days, at 1 month, and 6 months after the procedure, then at 12, 18, and 24 months post-procedure. The target lesion primary patency (TLPP) at 6 months post-procedure is the defined primary endpoint to evaluate the safety and effectiveness of the peripheral scoring drug balloon dilatation catheter. ### Conditions Module **Conditions:** - Arteriovenous Fistula Stenosis **Keywords:** - arteriovenous fistula stenosis - scoring - hemodialysis - drug-coated balloon ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 328 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects in this group are treated with Dissolve AV Peripheral Scoring Drug-coated Balloon dilatation catheter **Intervention Names:** - Device: Dissolve AV Peripheral Scoring Drug-coated Balloon **Label:** Dissolve AV Peripheral Scoring Drug-coated Balloon **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Dissolve AV Peripheral Scoring Drug-coated Balloon **Description:** Subjects in the test group are treated with Dissolve AV Peripheral Scoring Drug-coated Balloon **Name:** Dissolve AV Peripheral Scoring Drug-coated Balloon **Other Names:** - Scoring Drug-coated Balloon **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Target Lesion Primary Patency is defined as freedom from clinically driven Target Lesion Failure (TLF) (including +/-5mm proximal or distal of the target lesion) or Vascular Access Thrombosis. TLF is defined as the presence of at least one clinical symptom, sign or indicator (defined according to the NKF-K/DOQI guideline) due to target lesion stenosis (≥ 50% stenosis of the target lesion assessed by contrast angiography or ultrasound), including a significant increase in venous pressure during dialysis, high blood pressure, abnormal physical examination, decreased pump-controlled blood flow, decreased dialysis adequacy, brachial artery blood flow \< 600 ml/min or decreased by 25% compared with the previous follow-up, etc. **Measure:** Target Lesion Primary Patency (TLPP) at 6 months post-procedure **Time Frame:** 6 months post-procedure #### Secondary Outcomes **Description:** TLF is defined as the presence of at least one clinical symptom, sign or indicator (defined according to the NKF-K/DOQI guideline) due to target lesion stenosis (≥ 50% stenosis of the target lesion assessed by contrast angiography or ultrasound), including a significant increase in venous pressure during dialysis, high blood pressure, abnormal physical examination, decreased pump-controlled blood flow, decreased dialysis adequacy, brachial artery blood flow \< 600 ml/min or decreased by 25% compared with the previous follow-up, etc. **Measure:** Target Lesion Primary Patency (TLPP) **Time Frame:** 12, 24 months post-procedure **Description:** Proportion of patients whose peak systolic flow velocity ratio (PSVR) ≤ 2.0, as determined by Doppler ultrasound (DUS), at 6, 12, and 24 months post-procedure, so as to confirm the absence of restenosis. **Measure:** Proportion of patients whose peak systolic flow velocity ratio (PSVR) ≤ 2.0, as determined by Doppler ultrasound (DUS), so as to confirm the absence of restenosis **Time Frame:** 6, 12, 24 months post-procedure **Description:** Any reintervention of a target lesion (including +/-5 mm proximal or distal to the target lesion) as determined by clinical symptoms or dialysis indicators indicating that it is unable to perform dialysis. **Measure:** Clinically-driven Target Lesion Revascularization (CD-TLR) **Time Frame:** 1, 6, 12, 18, and 24 months post-procedure **Measure:** Clinically-driven Target Shunt Revascularization (CD-TSR) **Time Frame:** 1, 6, 12, 18, and 24 months post-procedure **Description:** Defined as the ability of the balloon to reach the target lesion, be successfully expanded without rupture, and be successfully withdrawn. Evaluation is based on single balloon dilation catheter. **Measure:** Device Success **Time Frame:** During the procedure **Description:** Defined as residual stenosis of the target lesion post-procedure is ≤ 30%, and no serious adverse events related to the trial device occurred during the perioperative period. **Measure:** Technical Success **Time Frame:** 0-5 days post-procedure **Description:** Defined as ability to complete at least one successful hemodialysis session post-procedure. **Measure:** Clinical Success **Time Frame:** 0-5 days post-procedure ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age ≥ 18 and ≤ 80 years old; 2. The patient's AVF/AVG is mature and has successfully completed hemodialysis at least once; 3. The target lesion is located at the AVF/AVG return vein and venous side anastomosis; 4. Hemodynamically significant AVF/AVG return vein stenosis ≥ 50% as assessed by ultrasound or contrast imaging, and any of the following clinical symptoms, signs or indicators are present, including significant increase in venous pressure during dialysis, abnormal physical examination, decreased pump-controlled blood flow, decreased adequacy of dialysis, brachial artery blood flow \< 600 ml/min or decreased by 25% compared with the previous follow-up visit, etc.; 5. The target lesion is a primary or restenotic lesion, consisting of one or more tandem lesions (if the total length of adjacent tandem lesions is ≤ 60 mm, it can be considered a single target lesion); 6. Visual inspection of the reference blood vessel diameter of the target lesion is between 4.0-8.0mm, and the total length of the target lesion is ≤ 60mm; 7. The patient voluntarily signs the informed consent form. Exclusion Criteria: 1. Women of childbearing age whose preoperative pregnancy test is not negative, and women who are breastfeeding; 2. Patients who have undergone major surgical treatment within 30 days before inclusion in the study; 3. Calcified lesions that are not expected to be expandable with balloons; 4. Patients with thrombosis at the access stenosis site; 5. The target lesion is located at the blood supply artery and arterial anastomosis; 6. Patients known to be allergic to or intolerant to contrast media and paclitaxel; 7. The patient's life expectancy is less than 2 years; 8. Patients with systemic lupus erythematosus and antineutrophil cytoplasmic antibody (ANCA)-associated small vessel vasculitis; 9. Patients with kidney transplantation or those who planned to undergo kidney transplantation or switch to peritoneal dialysis; 10. Vascular access infection or systemic active infection; 11. Those who have participated in unfinished clinical trials of other drugs or devices; 12. Patients with other medical conditions that the investigator believes are not suitable to participate in this study. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yuzhu Wang, MD **Phone:** 18701387950 **Role:** CONTACT #### Locations **Location 1:** **City:** Hefei **Contacts:** ***Contact 1:*** - **Name:** Liang Yuan - **Role:** CONTACT **Country:** China **Facility:** The Second Hospital of Anhui Medical University **State:** Anhui **Location 2:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yuzhu Wang, MD - **Phone:** 18701387950 - **Role:** CONTACT **Country:** China **Facility:** Beijing Haidian Hospital **State:** Beijing **Location 3:** **City:** Chongqing **Contacts:** ***Contact 1:*** - **Name:** Qining Fu - **Role:** CONTACT **Country:** China **Facility:** The First Affiliated Hospital of Chongqing Medical University **State:** Chongqing **Location 4:** **City:** Guanzhou **Contacts:** ***Contact 1:*** - **Name:** Riguang Liu - **Role:** CONTACT **Country:** China **Facility:** Guangzhou First People's Hospital **State:** Guangdong **Location 5:** **City:** Huizhou **Contacts:** ***Contact 1:*** - **Name:** Qiming Chen - **Role:** CONTACT **Country:** China **Facility:** Huizhou Central People's Hospital **State:** Guangdong **Location 6:** **City:** Shenzhen **Contacts:** ***Contact 1:*** - **Name:** Wei Liang - **Role:** CONTACT **Country:** China **Facility:** Peking University Shenzhen Hospital **State:** Guangdong **Location 7:** **City:** Shenzhen **Contacts:** ***Contact 1:*** - **Name:** Tiecheng Yang - **Role:** CONTACT **Country:** China **Facility:** The Eighth Affiliated Hospital, Sun Yat-sen University **State:** Guangdong **Location 8:** **City:** Liuzhou **Contacts:** ***Contact 1:*** - **Name:** Yuhong Chen - **Role:** CONTACT **Country:** China **Facility:** Liuzhou Traditional Chinese Medical Hospital **State:** Guangxi **Location 9:** **City:** Nanning **Contacts:** ***Contact 1:*** - **Name:** Xiaomei Peng - **Role:** CONTACT **Country:** China **Facility:** Foresea Life Insurance Guangxi Hospital **State:** Guangxi **Location 10:** **City:** Guiyang **Contacts:** ***Contact 1:*** - **Name:** Zongyang Liu - **Role:** CONTACT **Country:** China **Facility:** The Affiliated Cancer Hospital of Guizhou Medical University **State:** Guizhou **Location 11:** **City:** Zhengzhou **Contacts:** ***Contact 1:*** - **Name:** Hongtao Zhang - **Role:** CONTACT **Country:** China **Facility:** Henan Provincial People's Hospital **State:** Henan **Location 12:** **City:** Wuhan **Contacts:** ***Contact 1:*** - **Name:** Fan He - **Role:** CONTACT **Country:** China **Facility:** Tongji Hospital Affiliated To Tongji Medical College HUST **State:** Hubei **Location 13:** **City:** Changsha **Contacts:** ***Contact 1:*** - **Name:** Yong Xu - **Role:** CONTACT **Country:** China **Facility:** Changsha Jieao Kidney Disease Hospital **State:** Hunan **Location 14:** **City:** Changsha **Contacts:** ***Contact 1:*** - **Name:** Xun Luo - **Role:** CONTACT **Country:** China **Facility:** Hunan Provincial People's Hospital **State:** Hunan **Location 15:** **City:** Changsha **Contacts:** ***Contact 1:*** - **Name:** Hong Wu - **Role:** CONTACT **Country:** China **Facility:** The Second Xiangya Hospital of Central South University **State:** Hunan **Location 16:** **City:** Nanchang **Contacts:** ***Contact 1:*** - **Name:** Yan Yan - **Role:** CONTACT **Country:** China **Facility:** The First Affiliated Hospital of Nanchang University **State:** Jiangxi **Location 17:** **City:** Changchun **Contacts:** ***Contact 1:*** - **Name:** Mingxin Chang - **Role:** CONTACT **Country:** China **Facility:** The Affiliated Hospital To Changchun University of Chinese Medicine **State:** Jilin **Location 18:** **City:** Xi'an **Contacts:** ***Contact 1:*** - **Name:** Shifeng Yang - **Role:** CONTACT **Country:** China **Facility:** The First Affiliated Hospital of Xi'an Jiaotong University **State:** Shaanxi **Location 19:** **City:** Dezhou **Contacts:** ***Contact 1:*** - **Name:** Jing Sun - **Role:** CONTACT **Country:** China **Facility:** Qilu Hospital of Shandong University Dezhou Hospital **State:** Shandong **Location 20:** **City:** Jinan **Contacts:** ***Contact 1:*** - **Name:** Xiaoping Wang - **Role:** CONTACT **Country:** China **Facility:** Central Hospital Affiliated To Shandong First Medical University **State:** Shandong **Location 21:** **City:** Jinan **Contacts:** ***Contact 1:*** - **Name:** Zunsong Wang - **Role:** CONTACT **Country:** China **Facility:** The First Affiliated Hospital of Shandong First Medical University **State:** Shandong **Location 22:** **City:** Qingdao **Contacts:** ***Contact 1:*** - **Name:** Jian Sun - **Role:** CONTACT **Country:** China **Facility:** Qingdao Municipal Hospital **State:** Shandong **Location 23:** **City:** Rizhao **Contacts:** ***Contact 1:*** - **Name:** Hong Zhang - **Role:** CONTACT **Country:** China **Facility:** People's Hospital of Rizhao **State:** Shandong **Location 24:** **City:** Taiyuan **Contacts:** ***Contact 1:*** - **Name:** Hua Chen - **Role:** CONTACT **Country:** China **Facility:** Shanxi Bethune Hospital **State:** Shanxi **Location 25:** **City:** Chengdu **Contacts:** ***Contact 1:*** - **Name:** Qiang He - **Role:** CONTACT **Country:** China **Facility:** Sichuan Academy of Medical Sciences Sichuan Provincial People's Hospital **State:** Sichuan **Location 26:** **City:** Chengdu **Contacts:** ***Contact 1:*** - **Name:** Ping Fu - **Role:** CONTACT **Country:** China **Facility:** West China Hospital Sichuan University **State:** Sichuan **Location 27:** **City:** Mianyang **Contacts:** ***Contact 1:*** - **Name:** Dan Liao - **Role:** CONTACT **Country:** China **Facility:** Mianyang Central Hospital **State:** Sichuan **Location 28:** **City:** Nanchong **Contacts:** ***Contact 1:*** - **Name:** Heping Zhang - **Role:** CONTACT **Country:** China **Facility:** Affiliated Hospital of North Sichuan Medical College **State:** Sichuan **Location 29:** **City:** Hangzhou **Contacts:** ***Contact 1:*** - **Name:** Hua Li - **Role:** CONTACT **Country:** China **Facility:** Sir Run Run Shaw Hospital Zhejiang University School of medicine **State:** Zhejiang **Location 30:** **City:** Hangzhou **Contacts:** ***Contact 1:*** - **Name:** Hua Jiang - **Role:** CONTACT **Country:** China **Facility:** The First Affiliated Hospital, Zhejiang University School of Medicine **State:** Zhejiang **Location 31:** **City:** Jinhua **Contacts:** ***Contact 1:*** - **Name:** Yangbiao He - **Role:** CONTACT **Country:** China **Facility:** Jinhua Hospital of TCM **State:** Zhejiang **Location 32:** **City:** Taizhou **Contacts:** ***Contact 1:*** - **Name:** Liyun Xu - **Role:** CONTACT **Country:** China **Facility:** Taizhou Hospital of Zhejiang Province **State:** Zhejiang **Location 33:** **City:** Ürümqi **Contacts:** ***Contact 1:*** - **Name:** Alpati - **Role:** CONTACT **Country:** China **Facility:** The First Affiliated Hospital of Xinjiang Medical University **State:** Ürümqi #### Overall Officials **Official 1:** **Affiliation:** Beijing Haidian Hospital **Name:** Yuzhu Wang, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000001165 - Term: Arteriovenous Malformations - ID: D000054079 - Term: Vascular Malformations - ID: D000018376 - Term: Cardiovascular Abnormalities - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000016157 - Term: Vascular Fistula - ID: D000014652 - Term: Vascular Diseases - ID: D000000013 - Term: Congenital Abnormalities ### 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: BC16 - Name: Diseases and Abnormalities at or Before Birth ### Condition Browse Module - Browse Leaves - ID: M6475 - Name: Constriction, Pathologic - Relevance: HIGH - As Found: Stenosis - ID: M8532 - Name: Fistula - Relevance: HIGH - As Found: Fistula - ID: M4472 - Name: Arteriovenous Fistula - Relevance: HIGH - As Found: Arteriovenous Fistula - ID: M7292 - Name: Dilatation, Pathologic - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M4473 - Name: Arteriovenous Malformations - Relevance: LOW - As Found: Unknown - ID: M27558 - Name: Vascular Malformations - Relevance: LOW - As Found: Unknown - ID: M20503 - Name: Cardiovascular Abnormalities - Relevance: LOW - As Found: Unknown - ID: M18619 - Name: Vascular Fistula - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001164 - Term: Arteriovenous Fistula - ID: D000003251 - Term: Constriction, Pathologic - ID: D000005402 - Term: Fistula ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422832 **Acronym:** REMOTI-HF **Brief Title:** Remote Monitoring To Identify Worsening Heart Failure The REMOTI-HF Randomized Clinical Trial **Official Title:** Remote Monitoring To Identify Worsening Heart Failure: The REMOTI-HF Randomized Clinical Trial #### Organization Study ID Info **ID:** RHF230808 #### Organization **Class:** OTHER **Full Name:** Centro Hospitalar e Universitário de Coimbra, E.P.E. ### Status Module #### Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-02-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Centro Hospitalar e Universitário de Coimbra, E.P.E. #### Responsible Party **Investigator Affiliation:** Centro Hospitalar e Universitário de Coimbra, E.P.E. **Investigator Full Name:** Goncalo Terleira Batista **Investigator Title:** Cardiology Resident **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:** Heart failure, characterized by high mortality and morbidity rates, frequent hospital admissions, and prolonged stays in cardiology wards, significantly impacts patients' quality of life. The REMOTI-HF is a single-center randomized controlled trial designed to assess the impact of remote monitoring, utilizing the HeartLogic and TriageHF algorithms, in patients with heart failure with implantable cardioverter defibrillator or cardiac resynchronization therapy. The primary endpoints include mortality, hospital admissions related to heart failure, and visits for worsening heart failure. Moreover, we will explore the full capabilities of these algorithms, by analysing the association of physical activity, measured by the devices, with the same key outcomes. Additionally, the research will explore the relationship between the absolute values provided by the algorithms and NT-proBNP values. **Detailed Description:** Patients will be randomized into two arms: one with the activation of the algorithm and the other with no active algorithm. The algorithm is programmed to alert our team upon detecting a patient at risk of worsening heart failure. When an alarm is triggered, the patient will receive a telephone call from the investigation team. Subsequently, the patient may be scheduled for a hospital visit, or ambulatory medication adjustments can be made. For patients in whom the algorithm is deactivated, no such alarm mechanism will be in place. Patients in both arms will undergo comparison based on relevant heart failure events, defined as follows: * All-Cause Mortality * Hospital Admission for Heart Failure * Hospital Visit for Worsening Heart Failure * Ventricular Arrhythmias * Atrial Arrhythmias Additionally, the study will explore the association between physical activity measured by the devices and these specified events. In addition to evaluating patient outcomes, a correlation analysis will be conducted to examine the relationship between the absolute value provided by the algorithm and absolute NT-proBNP values. This analysis aims to assess the concordance and potential predictive value of the algorithm's output with established biomarkers, specifically NT-proBNP, in the context of heart failure progression and severity (if possible). ### Conditions Module **Conditions:** - Heart Failure - Arrythmia **Keywords:** - Heart Failure - Remote Monitoring - ICD - CRT ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Masking Description:** Patients will not know whether the algorithms was activated or not at the beginning of the study. However, if a contact with the patient is made due to the algorithm, the patient will then understand they are not on the control group. The person responsible for contacts will also know if an individual patient is on the control or intervention group. **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 270 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In this group the respective algorithm will be activated and alerts will be sent according to its design **Intervention Names:** - Other: HeartLogic or TriageHF Algorithms for implantable devices **Label:** Interventional group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The algorithm will not be activated and follow-up will continue as if the patient was not included in the study. **Label:** Control Group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Interventional group **Description:** Activation of the HeartLogic and TriageHF algorithms for implantable devices and correctly act according to its design **Name:** HeartLogic or TriageHF Algorithms for implantable devices **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** All-cause mortality, Hospital Admission for Heart Failure, Ventricular Arrhythmias and Worsening Heart Failure as defined in the secondary outcome area. **Measure:** Primary Composite Outcome **Time Frame:** 2 years #### Secondary Outcomes **Description:** All-cause mortality **Measure:** All-cause mortality **Time Frame:** 2 years **Description:** Patient admission to the hospital with symptoms or signs of congestive heart failure, needing intravenous drugs for symptom relief, ultrafiltration therapy, or other parenteral therapy **Measure:** Hospital admission for Heart Failure **Time Frame:** 2 years **Description:** Unscheduled hospital visit (to the emergency department or unscheduled consultation) due to signs or symptoms of heart failure, where intravenous diuretics were administered or ambulatory diuretic dosage was increased. **Measure:** Worsening Heart failure **Time Frame:** 2 eras **Description:** Detection of any ventricular arrhythmia through hospital visit, appropriate device therapy or device detection **Measure:** Ventricular Arrhythmias **Time Frame:** 2 years **Description:** Occurrence of any atrial arrhythmia prompting medical evaluation. **Measure:** Atrial Arrhytmias **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Possession of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device that is compatible with the HeartLogic or TriageHF algorithms. * Left ventricular ejection fraction at the time of device implantation must be equal to or less than 35%. Exclusion Criteria: * Younger than 18 years old or older than 85 years old. * Unable to be contacted when out of the hospital. * Presence of severe cognitive impairment. * Currently on the heart transplant waiting list **Maximum Age:** 85 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Gonçalo Batista, MD **Phone:** 963596295 **Phone Ext:** 00351 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** ULS Coimbra **Name:** Gonçalo Batista, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## 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: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M9421 - Name: Heart Failure - Relevance: HIGH - As Found: Heart Failure - ID: M4453 - Name: Arrhythmias, Cardiac - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006333 - Term: Heart Failure ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422819 **Acronym:** HRV_BFB_FND **Brief Title:** Clinical Evaluation of HRV Biofeedback in Functional Neurological Disorders Compared to Placebo **Official Title:** Probing the Heart Rate Variability Biofeedback as an Innovative and Non-invasive Treatment for Functional Neurological Disorders Guided by a Multimodal Approach of Autonomic Nervous System. #### Organization Study ID Info **ID:** 2024-12156 #### Organization **Class:** OTHER **Full Name:** Centre hospitalier de l'Université de Montréal (CHUM) ### Status Module #### Completion Date **Date:** 2027-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **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:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Laboratoire de Psychologie et NeuroCognition #### Lead Sponsor **Class:** OTHER **Name:** Centre hospitalier de l'Université de Montréal (CHUM) #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Evaluation of the clinical effects of the Heart Rate Variability biofeedback training with patients suffering from Functional neurological Disorders compared with placebo. **Detailed Description:** Although Functional Neurological Disorders (FND) represent one of the most common reasons for consultation in Neurology, the pathological mechanisms remain unexplained. Recent studies suggest disrupted emotional processes in patients with FND and disturbed autonomic nervous system profiles, highligting the hypothesis of autonomic endophenotypes among the FND population. The Heart Rate Variability Biofeedback (HRV-BFB) is an innovative and non-invasive approach, based on the self-regulation of autonomic physiological processes. It has shown promising results in clinical and non-clinical populations but has never been assessed in an adult FND population. Therefore, this approach appears particularly promising for understanding the mechanisms underlying FND and developing personalized therapy. The main objective is to investigate the clinical effects of HRV-BFB on FND patients compared to placebo in a single-blind crossover design. The investigators predict that depending on their autonomic profile, patients will respond to HRV-BFB to varying degrees. Firstly, patients with FND will prospectively undergo an comprehensive clinical evaluation considering symptoms, functional capacity, quality of life, and an assessment of the physical and psychological comorbidities. Then patients will complete an emotional task and undergo multimodal autonomic measures. Cluster analyses will be conducted to identify both dysfunctional and functional autonomic profiles associated with the clinical exploration, enabling confirmation of the endophenotypes hypothesis and allowing for specific characterization of the profils. The clinical evaluation of the beneficial effects of HRV BFB will rely on repeated mesures of symptoms, functional capacity, and quality of life at scheduled points in time before and after the both interventions (HRV-BFB and pseudo-BFB). The emotional task and autonomic measures will be repeated simultaneously. ### Conditions Module **Conditions:** - Functional Neurological Disorder **Keywords:** - Functional Neurological Disorder - Emotional dysregulation - Autonomic nervous system - Endophenotypes - Biofeedback of Heart Rate Variability - Transdiagnostic approach ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** This study consists of 5 visits (V1, V2, V3, V4, V5). At V1, participants will be randomized into two groups: HRV-BFB (experimental group) or Pseudo HRV-BFB (control group). Participants will remain single-blinded after randomization. Depending on the assigned group, participants will practice one specific intervention during the first 30-day period (V1-V2). At V2, participants will switch to the other arm and practice the second intervention during the second 30-day period (V2-V3). At V3, both interventions will end, and participants will be unblinded and encouraged to continue HRV-BFB at home. Clinical evaluation will be repeated 5 times at day 1 (V1), days 30 +/- 10 (V2), days 60 +/- 10 (V2), 6 months (V4) and 1 year (V5). The research team will exercise extreme caution to ensure consistent instructions and feedback, minimizing biases associated with lack of double-blinding. ##### Masking Info **Masking:** SINGLE **Masking Description:** The participants won't be informed of the condition to which they belong. A debriefing will be done at the end of the last intervention (V3) for each participant. **Who Masked:** - PARTICIPANT **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 31 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants assigned to the experimental group will undergo HRV Biofeedback training using the Inner Balance Coherence Plus® software. This software incorporates a Bluetooth plethysmograph ear sensor, which will transmit cardiac pulse data to the Inner Balance Coherence Plus smartphone app, where the EmWave Pro® Plus software will extract HRV in real-time. This software will display the participant's HRV-BFB curve on their smartphone. The installation of the program and necessary instructions for its use will be provided at the first visit (V1). Fractional training sessions of 8 minutes will be recommended, twice daily for 30 days (during the period V1-V2 or the period V2-V3). Respiratory instructions will differ between the two interventions. During the HRV-BFB intervention, participants will be instructed to maximize their HRV. **Intervention Names:** - Other: Heart rate variability Biofeedback [HRV-BFB] **Label:** Experimental group (HRV-BFB training) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants assigned to the placebo group will undergo a pseudo HRV Biofeedback training using the same Inner Balance Coherence Plus® software and ear sensor. The software will similarly display the participant's HRV-BFB curve on their smartphone. The installation of the program and necessary instructions for its use will be provided at the first visit (V1). To manage placebo effects, the same fractional training sessions of 8 minutes will be recommended, twice daily for 30 days (during the period V1-V2 or the period V2-V3). Respiratory instructions will differ between the two interventions. During the placebo pseudo BFB training, participants will be instructed to no have specific effect on HRV. **Intervention Names:** - Other: Pseudo HRV-BFB **Label:** Placebo Control group (Pseudo HRV-BFB training) **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental group (HRV-BFB training) **Description:** Biofeedback (BFB), sometimes referred to as "biological feedback technique," is a non-invasive and non-pharmacological approach based on physiological recordings that provide real-time feedback enabling people to learn how to control their physiological processes, which are typically unconscious and beyond their control. HRV-BFB specifically targets heart rate variability (HRV), which can help regulate the autonomic nervous system (including vagal tone and sympathetic-parasympathetic balance) as well as emotional states. HRV-BFB has been clinically and experimentally validated as a physiological intervention and has demonstrated its effectiveness. However, it has never been studied in an adult FND population. **Name:** Heart rate variability Biofeedback [HRV-BFB] **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Placebo Control group (Pseudo HRV-BFB training) **Description:** The pseudo HRV-BFB intervention aims to implement the same HRV BFB methods with no specific effect on HRV. **Name:** Pseudo HRV-BFB **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The impression improvement and severity of the core symptoms will be measured by the participant using the Clinical Global Impression Improvement and/or Severity scale (CGI-I \& CGI-S; French version Busner \& Targum, 2007). This scale includes 2 items. **Measure:** Patient Clinical Global Impression Score **Time Frame:** Day 1 (V1) **Description:** The impression improvement and severity of the core symptoms will be measured by the participant using the Clinical Global Impression Improvement and/or Severity scale ( (CGI-I \& CGI-S; French version Busner \& Targum, 2007). This scale includes 2 items. **Measure:** Patient Clinical Global Impression Score **Time Frame:** Up to 40 days from V1 (V2) **Description:** The impression improvement and severity of the core symptoms will be measured by the participant using the Clinical Global Impression Improvement and/or Severity scale ( (CGI-I \& CGI-S; French version Busner \& Targum, 2007). This scale includes 2 items. **Measure:** Patient Clinical Global Impression Score **Time Frame:** Up to 80 days from V1 (V3) **Description:** The impression improvement and severity of the core symptoms will be measured by the participant using the Clinical Global Impression Improvement and/or Severity scale ( (CGI-I \& CGI-S; French version Busner \& Targum, 2007). This scale includes 2 items. **Measure:** Patient Clinical Global Impression Score **Time Frame:** Up to 180 days from V1 (V4) **Description:** The impression improvement and severity of the core symptoms will be measured by the participant using the Clinical Global Impression Improvement and/or Severity scale ( (CGI-I \& CGI-S; French version Busner \& Targum, 2007). This scale includes 2 items. **Measure:** Patient Clinical Global Impression Score **Time Frame:** Up to 360 days from V1 (V5) **Description:** The impression improvement and severity of the core symptoms will be measured by the clinician using the Clinical Global Impression Improvement and/or Severity scale (CGI; French version Busner \& Targum, 2007). This scale includes 2 items. **Measure:** Clinician Clinical Global Impression Score **Time Frame:** Day 1 (V1) **Description:** The impression improvement and severity of the core symptoms will be measured by the clinician using the Clinical Global Impression Improvement and/or Severity scale (CGI; French version Busner \& Targum, 2007). This scale includes 2 items. **Measure:** Clinician Clinical Global Impression Score **Time Frame:** Up to 40 days from V1 (V2) **Description:** The impression improvement and severity of the core symptoms will be measured by the clinician using the Clinical Global Impression Improvement and/or Severity scale (CGI; French version Busner \& Targum, 2007). This scale includes 2 items. **Measure:** Clinician Clinical Global Impression Score **Time Frame:** Up to 80 days from V1 (V3) **Description:** The impression improvement and severity of the core symptoms will be measured by the clinician using the Clinical Global Impression Improvement and/or Severity scale (CGI; French version Busner \& Targum, 2007). This scale includes 2 items. **Measure:** Clinician Clinical Global Impression Score **Time Frame:** Up to 180 days from V1 (V4) **Description:** The impression improvement and severity of the core symptoms will be measured by the clinician using the Clinical Global Impression Improvement and/or Severity scale (CGI; French version Busner \& Targum, 2007). This scale includes 2 items. **Measure:** Clinician Clinical Global Impression Score **Time Frame:** Up to 360 days from V1 (V5) **Description:** The Quality of life Score will be measured using the 36-Item Short Form Survey (SF-36; Jenkinson et al., 1993; French version Leplège et al., 1998). This scale includes 36 items. **Measure:** Quality of life Score **Time Frame:** Day 1 (V1) **Description:** The Quality of life Score will be measured using the 36-Item Short Form Survey (SF-36; Jenkinson et al., 1993; French version Leplège et al., 1998). This scale includes 36 items. **Measure:** Quality of life Score **Time Frame:** Up to 40 days from V1 (V2) **Description:** The Quality of life Score will be measured using the 36-Item Short Form Survey (SF-36; Jenkinson et al., 1993; French version Leplège et al., 1998). This scale includes 36 items. **Measure:** Quality of life Score **Time Frame:** Up to 80 days from V1 (V3) **Description:** The Quality of life Score will be measured using the 36-Item Short Form Survey (SF-36; Jenkinson et al., 1993; French version Leplège et al., 1998). This scale includes 36 items. **Measure:** Quality of life Score **Time Frame:** Up to 180 days from V1 (V4) **Description:** The Quality of life Score will be measured using the 36-Item Short Form Survey (SF-36; Jenkinson et al., 1993; French version Leplège et al., 1998). This scale includes 36 items. **Measure:** Quality of life Score **Time Frame:** Up to 360 days from V1 (V5) **Description:** The Self-perception of Occupation will be measured using the Occupational Self- Assessment scale (OSA; French version Baron et al.,2006). This scale includes 21 items. **Measure:** Self-perception of Occupation Score **Time Frame:** Day 1 (V1) **Description:** The Self-perception of Occupation will be measured using the Occupational Self- Assessment scale (OSA; French version Baron et al.,2006). This scale includes 21 items. **Measure:** Self-perception of Occupation Score **Time Frame:** Up to 40 days from V1 (V2) **Description:** The Self-perception of Occupation will be measured using the Occupational Self- Assessment scale (OSA; French version Baron et al.,2006). This scale includes 21 items. **Measure:** Self-perception of Occupation Score **Time Frame:** Up to 80 days from V1 (V3) **Description:** The Self-perception of Occupation will be measured using the Occupational Self- Assessment scale (OSA; French version Baron et al.,2006). This scale includes 21 items. **Measure:** Self-perception of Occupation Score **Time Frame:** Up to 180 days from V1 (V4) **Description:** The Self-perception of Occupation will be measured using the Occupational Self- Assessment scale (OSA; French version Baron et al.,2006). This scale includes 21 items. **Measure:** Self-perception of Occupation Score **Time Frame:** Up to 360 days from V1 (V5) #### Secondary Outcomes **Description:** The other physical symptoms will be measured using the Patient Health Questionnaire (PHQ-15; French version Kroenke et al., 2002). This scale includes 15 items. **Measure:** Other physical symptoms score **Time Frame:** Day 1 (V1) **Description:** The other physical symptoms will be measured using the Patient Health Questionnaire (PHQ-15; French version Kroenke et al., 2002). This scale includes 15 items. **Measure:** Other physical symptoms score **Time Frame:** Up to 40 days from V1 (V2) **Description:** The other physical symptoms will be measured using the Patient Health Questionnaire (PHQ-15; French version Kroenke et al., 2002). This scale includes 15 items. **Measure:** Other physical symptoms score **Time Frame:** Up to 80 days from V1 (V3) **Description:** The other physical symptoms will be measured using the Patient Health Questionnaire (PHQ-15; French version Kroenke et al., 2002). This scale includes 15 items. **Measure:** Other physical symptoms score **Time Frame:** Up to 180 days from V1 (V4) **Description:** The other physical symptoms will be measured using the Patient Health Questionnaire (PHQ-15; French version Kroenke et al., 2002). This scale includes 15 items. **Measure:** Other physical symptoms score **Time Frame:** Up to 360 days from V1 (V5) **Description:** The Depressive symptoms score will be measured using the for Epidemiologic Studies-- Depression (CES-D; Radloff, 1977; French version Führer \& Rouillon, 1989). This scale includes 20 items. **Measure:** Depressive symptoms score **Time Frame:** Day 1 (V1) **Description:** The Depressive symptoms score will be measured using the for Epidemiologic Studies-- Depression (CES-D; Radloff, 1977; French version Führer \& Rouillon, 1989). This scale includes 20 items. **Measure:** Depressive symptoms score **Time Frame:** Up to 40 days from V1 (V2) **Description:** The Depressive symptoms score will be measured using the for Epidemiologic Studies-- Depression (CES-D; Radloff, 1977; French version Führer \& Rouillon, 1989). This scale includes 20 items. **Measure:** Depressive symptoms score **Time Frame:** Up to 80 days from V1 (V3) **Description:** The Depressive symptoms score will be measured using the for Epidemiologic Studies-- Depression (CES-D; Radloff, 1977; French version Führer \& Rouillon, 1989). This scale includes 20 items. **Measure:** Depressive symptoms score **Time Frame:** Up to 180 days from V1 (V4) **Description:** The Depressive symptoms score will be measured using the for Epidemiologic Studies-- Depression (CES-D; Radloff, 1977; French version Führer \& Rouillon, 1989). This scale includes 20 items. **Measure:** Depressive symptoms score **Time Frame:** Up to 360 days from V1 (V5) **Description:** The Trait anxiety score will be measured using the Trait Anxiety Inventory (STAI- B; Spielberger, 1989; French version Bruchon-Schweitzer \& Paulhan, 1993; Huyghe Lydie, 2021). This scale includes 20 items. **Measure:** Trait anxiety score **Time Frame:** Day 1 (V1) **Description:** The Trait anxiety score will be measured using the Trait Anxiety Inventory (STAI- B; Spielberger, 1989; French version Bruchon-Schweitzer \& Paulhan, 1993; Huyghe Lydie, 2021). This scale includes 20 items. **Measure:** Trait anxiety score **Time Frame:** Up to 40 days from V1 (V2) **Description:** The Trait anxiety score will be measured using the Trait Anxiety Inventory (STAI- B; Spielberger, 1989; French version Bruchon-Schweitzer \& Paulhan, 1993; Huyghe Lydie, 2021). This scale includes 20 items. **Measure:** Trait anxiety score **Time Frame:** Up to 80 days from V1 (V3) **Description:** The Trait anxiety score will be measured using the Trait Anxiety Inventory (STAI- B; Spielberger, 1989; French version Bruchon-Schweitzer \& Paulhan, 1993; Huyghe Lydie, 2021). This scale includes 20 items. **Measure:** Trait anxiety score **Time Frame:** Up to 180 days from V1 (V4) **Description:** The Trait anxiety score will be measured using the Trait Anxiety Inventory (STAI- B; Spielberger, 1989; French version Bruchon-Schweitzer \& Paulhan, 1993; Huyghe Lydie, 2021). This scale includes 20 items. **Measure:** Trait anxiety score **Time Frame:** Up to 360 days from V1 (V5) **Description:** The quality of sleep will be measured using the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 2002, French versionAit-Aoudia et al., 2013). This scale includes 7 items. **Measure:** Quality of sleep measure **Time Frame:** Day 1 (V1) **Description:** The quality of sleep will be measured using the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 2002, French versionAit-Aoudia et al., 2013). This scale includes 7 items. **Measure:** Quality of sleep measure **Time Frame:** Up to 40 days from V1 (V2) **Description:** The quality of sleep measure will be measure using the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 2002, French versionAit-Aoudia et al., 2013). This scale includes 7 items. **Measure:** Quality of sleep measure **Time Frame:** Up to 80 days from V1 (V3) **Description:** The quality of sleep will be measured using the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 2002, French versionAit-Aoudia et al., 2013). This scale includes 7 items. **Measure:** Quality of sleep measure **Time Frame:** Up to 180 days from V1 (V4) **Description:** The quality of sleep will be measured using the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 2002, French versionAit-Aoudia et al., 2013). This scale includes 7 items. **Measure:** Quality of sleep measure **Time Frame:** Up to 360 days from V1 (V5) **Description:** The Dissociative Experiences will be measured using the Dissociative Experiences Scale EDS; Steinberg et al., 1991; french version Eve Bernstein Carlson et Frank W. Putnam, 1986). This scale includes 28 items. **Measure:** Dissociative Experiences **Time Frame:** Day 1 (V1) **Description:** The Dissociative Experiences will be measured using the Dissociative Experiences Scale EDS; Steinberg et al., 1991; french version Eve Bernstein Carlson et Frank W. Putnam, 1986). This scale includes 28 items. **Measure:** Dissociative Experiences **Time Frame:** Up to 40 days from V1 (V2) **Description:** The Dissociative Experiences will be measured using the Dissociative Experiences Scale EDS; Steinberg et al., 1991; french version Eve Bernstein Carlson et Frank W. Putnam, 1986). This scale includes 28 items. **Measure:** Dissociative Experiences **Time Frame:** Up to 80 days from V1 (V3) **Description:** The Dissociative Experiences will be measured using the Dissociative Experiences Scale EDS; Steinberg et al., 1991; french version Eve Bernstein Carlson et Frank W. Putnam, 1986). This scale includes 28 items. **Measure:** Dissociative Experiences **Time Frame:** Up to 180 days from V1 (V4) **Description:** The Dissociative Experiences will be measured using the Dissociative Experiences Scale EDS; Steinberg et al., 1991; french version Eve Bernstein Carlson et Frank W. Putnam, 1986). This scale includes 28 items. **Measure:** Dissociative Experiences **Time Frame:** Up to 360 days from V1 (V5) **Description:** Alexithymia score will be measured using the Toronto Alexithymia Scale (TAS-20; French version Loas, 1996). This scale includes 20 items. **Measure:** Alexithymia score **Time Frame:** Day 1 (V1) **Description:** Brief Illness Perception score will be measured using the Brief Illness Perception Questionnaire (B-IPQ) (Moss-Morris et al., 2002 ; French version Demoulin et al., 2015). This scale includes 9 items. **Measure:** Brief Illness Perception score **Time Frame:** Day 1 (V1) **Description:** Brief Illness Perception score will be measured using the Brief Illness Perception Questionnaire (B-IPQ) (Moss-Morris et al., 2002 ; French version Demoulin et al., 2015). This scale includes 9 items. **Measure:** Brief Illness Perception score **Time Frame:** Up to 40 days from V1 (V2) **Description:** Brief Illness Perception score will be measured using the Brief Illness Perception Questionnaire (B-IPQ) (Moss-Morris et al., 2002 ; French version Demoulin et al., 2015). This scale includes 9 items. **Measure:** Brief Illness Perception score **Time Frame:** Up to 80 days from V1 (V3) **Description:** Brief Illness Perception score will be measured using the Brief Illness Perception Questionnaire (B-IPQ) (Moss-Morris et al., 2002 ; French version Demoulin et al., 2015). This scale includes 9 items. **Measure:** Brief Illness Perception score **Time Frame:** Up to 180 days from V1 (V4) **Description:** Brief Illness Perception score will be measured using the Brief Illness Perception Questionnaire (B-IPQ) (Moss-Morris et al., 2002 ; French version Demoulin et al., 2015). This scale includes 9 items. **Measure:** Brief Illness Perception score **Time Frame:** Up to 360 days from V1 (V5) **Description:** The Emotion Regulation Profile score will be measured using the Emotion Regulation Profile-Revised (ERP-R) (French version Nelis et al., 2011). This scale includes 15 items. **Measure:** Emotion Regulation Profile **Time Frame:** Day 1 (V1) **Description:** The Emotion Regulation Profile score will be measured using the Emotion Regulation Profile-Revised (ERP-R) (French version Nelis et al., 2011). This scale includes 15 items. **Measure:** Emotion Regulation Profile **Time Frame:** Up to 40 days from V1 (V2) **Description:** The Emotion Regulation Profile score will be measured using the Emotion Regulation Profile-Revised (ERP-R) (French version Nelis et al., 2011). This scale includes 15 items. **Measure:** Emotion Regulation Profile **Time Frame:** Up to 80 days from V1 (V3) **Description:** The Emotion Regulation Profile score will be measured using the Emotion Regulation Profile-Revised (ERP-R) (French version Nelis et al., 2011). This scale includes 15 items. **Measure:** Emotion Regulation Profile **Time Frame:** Up to 180 days from V1 (V4) **Description:** The Emotion Regulation Profile score will be measured using the Emotion Regulation Profile-Revised (ERP-R) (French version Nelis et al., 2011). This scale includes 15 items. **Measure:** Emotion Regulation Profile **Time Frame:** Up to 360 days from V1 (V5) **Description:** The Childhood Trauma profile will be measured using the Childhood Trauma Questionnaire-Short Form (CTQ; Frenc version Paquette et al., 2004). This scale includes 28 items. **Measure:** Childhood Trauma profile **Time Frame:** Day 1 (V1) **Description:** The Positive Affect and Negative Affects will be measured using the Positive Affect and Negative Affect Schedule (PANAS; Watson et al., 1988. French version Caci \& Bayle, 2007). To measure a global affective state, a score of positivity will be calculated by subtracting negative affect score from positive affect score. This scale includes 20 items. **Measure:** Positive Affect and Negative Affects **Time Frame:** Day 1 (V1) before the emotional induction task **Description:** The Positive Affect and Negative Affects will be measured using the Positive Affect and Negative Affect Schedule (PANAS; Watson et al., 1988. French version Caci \& Bayle, 2007). To measure a global affective state, a score of positivity will be calculated by subtracting negative affect score from positive affect score. This scale includes 20 items. **Measure:** Positive Affect and Negative Affects **Time Frame:** Day 1 (V1) after the emotional induction task **Description:** The Positive Affect and Negative Affects will be measured using the Positive Affect and Negative Affect Schedule (PANAS; Watson et al., 1988. French version Caci \& Bayle, 2007). To measure a global affective state, a score of positivity will be calculated by subtracting negative affect score from positive affect score. This scale includes 20 items. **Measure:** Positive Affect and Negative Affects **Time Frame:** Up to 40 days from V1 (V2) before the emotional re-exposure task **Description:** The Positive Affect and Negative Affects will be measured using the Positive Affect and Negative Affect Schedule (PANAS; Watson et al., 1988. French version Caci \& Bayle, 2007). To measure a global affective state, a score of positivity will be calculated by subtracting negative affect score from positive affect score. This scale includes 20 items. **Measure:** Positive Affect and Negative Affects **Time Frame:** Up to 40 days from V1 (V2) after the emotional re-exposure task **Description:** High Frequency (\>0.15 Hz), frequency-domain parameter. HF will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\]. **Measure:** High Frequency [HF] (>0.15 Hz) **Time Frame:** Day 1 (V1) **Description:** High Frequency (\>0.15 Hz), frequency-domain parameter. HF will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\]. **Measure:** High Frequency [HF] (>0.15 Hz) **Time Frame:** Up to 40 days from V1 (V2) **Description:** High Frequency (\>0.15 Hz), frequency-domain parameter. HF will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\]. **Measure:** High Frequency [HF] (>0.15 Hz) **Time Frame:** Up to 80 days from V1 (V3) **Description:** High Frequency (\>0.15 Hz), frequency-domain parameter. HF will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\]. **Measure:** High Frequency [HF] (>0.15 Hz) **Time Frame:** Up to 180 days from V1 (V4) **Description:** High Frequency (\>0.15 Hz), frequency-domain parameter. HF will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\]. **Measure:** High Frequency [HF] (>0.15 Hz) **Time Frame:** Up to 360 days from V1 (V5) **Description:** Root Mean Square of Successive Differences, Frequency-domain parameter. RMSSD will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\]. **Measure:** Root Mean Square of Successive Differences [RMSSD] **Time Frame:** Day 1 (V1) **Description:** Root Mean Square of Successive Differences, Frequency-domain parameter. RMSSD will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\]. **Measure:** Root Mean Square of Successive Differences [RMSSD] **Time Frame:** Up to 40 days from V1 (V2) **Description:** Root Mean Square of Successive Differences, Frequency-domain parameter. RMSSD will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\]. **Measure:** Root Mean Square of Successive Differences [RMSSD] **Time Frame:** Up to 80 days from V1 (V3) **Description:** Root Mean Square of Successive Differences, Frequency-domain parameter. RMSSD will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\]. **Measure:** Root Mean Square of Successive Differences [RMSSD] **Time Frame:** Up to 180 days from V1 (V4) **Description:** Root Mean Square of Successive Differences, Frequency-domain parameter. RMSSD will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\]. **Measure:** Root Mean Square of Successive Differences [RMSSD] **Time Frame:** Up to 360 days from V1 (V5) **Description:** Skin conductance responses \[SCR\] frequency : number of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR). **Measure:** Skin conductance responses [SCR] frequency **Time Frame:** Day 1 (V1) **Description:** Skin conductance responses \[SCR\] frequency : number of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR). **Measure:** Skin conductance responses [SCR] frequency **Time Frame:** Up to 40 days from V1 (V2) **Description:** Skin conductance responses \[SCR\] frequency : number of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR). **Measure:** Skin conductance responses [SCR] frequency **Time Frame:** Up to 80 days from V1 (V3) **Description:** Skin conductance responses \[SCR\] frequency : number of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR). **Measure:** Skin conductance responses [SCR] frequency **Time Frame:** Up to 180 days from V1 (V4) **Description:** Skin conductance responses \[SCR\] frequency : number of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR). **Measure:** Skin conductance responses [SCR] frequency **Time Frame:** Up to 360 days from V1 (V5) **Description:** Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR). **Measure:** Skin conductance responses [SCR] amplitude **Time Frame:** Day 1 (V1) **Description:** Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR). **Measure:** Skin conductance responses [SCR] amplitude **Time Frame:** Up to 40 days from V1 (V2) **Description:** Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR). **Measure:** Skin conductance responses [SCR] amplitude **Time Frame:** Up to 80 days from V1 (V3) **Description:** Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR). **Measure:** Skin conductance responses [SCR] amplitude **Time Frame:** Up to 180 days from V1 (V4) **Description:** Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR). **Measure:** Skin conductance responses [SCR] amplitude **Time Frame:** Up to 360 days from V1 (V5) **Description:** Delta frequency 0-4 Hertz band Delta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Delta frequency (0-4Hz) **Time Frame:** Day 1 (V1) **Description:** Delta frequency 0-4 Hertz band Delta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Delta frequency (0-4Hz) **Time Frame:** Up to 40 days from V1 (V2) **Description:** Delta frequency 0-4 Hertz band Delta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Delta frequency (0-4Hz) **Time Frame:** Up to 80 days from V1 (V3) **Description:** Theta frequency 4-7 Hertz band Theta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Theta frequency (4-7Hz) **Time Frame:** Day 1 (V1) **Description:** Theta frequency 4-7 Hertz band Theta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Theta frequency (4-7Hz) **Time Frame:** Up to 40 days from V1 (V2) **Description:** Theta frequency 4-7 Hertz band Theta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Theta frequency (4-7Hz) **Time Frame:** Up to 80 days from V1 (V3) **Description:** Alpha frequency 8-12 Hertz band Alpha frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Alpha frequency (8-12Hz) **Time Frame:** Day 1 (V1) **Description:** Alpha frequency 8-12 Hertz band Alpha frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Alpha frequency (8-12Hz) **Time Frame:** Up to 40 days from V1 (V2) **Description:** Alpha frequency 8-12 Hertz band Alpha frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Alpha frequency (8-12Hz) **Time Frame:** Up to 80 days from V1 (V3) **Description:** Beta frequency 13-30 Hertz band Beta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Beta frequency (13-30Hz) **Time Frame:** Day 1 (V1) **Description:** Beta frequency 13-30 Hertz band Beta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Beta frequency (13-30Hz) **Time Frame:** Up to 40 days from V1 (V2) **Description:** Beta frequency 13-30 Hertz band Beta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Beta frequency (13-30Hz) **Time Frame:** Up to 80 days from V1 (V3) **Description:** Gamma frequency \>30 Hertz band Gamma frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Gamma frequency (>30Hz) **Time Frame:** Day 1 (V1) **Description:** Gamma frequency \>30 Hertz band Gamma frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Gamma frequency (>30Hz) **Time Frame:** Up to 40 days from V1 (V2) **Description:** Gamma frequency \>30 Hertz band Gamma frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning. **Measure:** Gamma frequency (>30Hz) **Time Frame:** Up to 80 days from V1 (V3) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Functional Neurological Disorders (FND) diagnosis must be medically established * Participants must have a smartphone (android ou Iphone) * Participants must be of the age of majority * Participants must have signed an informed consent * Sufficiently fluent in French to understand study documents and instructions * Consistency in performing repeated questionnaires * Normal or corrected-to-normal visual acuity Exclusion Criteria: * Specially protected participants: juveniles, pregnant womens, nursing mothers, law's protection peoples * Participants suffering from a severe psychiatric disease needing specialised attention * History of severe neurosurgical pathology * Alcohol dependence or drug use * Participants suffering from or have suffered from a severe disease causing autonomic dysfunctions (heart failure, asthma, blood disease, renal failure, peripheral neuropathy, vagotomy, thyroid disorder, alcoholism, liver disease, amyloidosis) * Participants taking medication which could be impact autonomic nervous system activity (anticholinergic, antiarrhythmics, clonidine, beta-blockers, tricyclic anti-depressants, metronidazole) * Participants placing under judicial or administrative supervisions **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jasmine Carlier, PhD student **Phone:** (+33)680891913 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Dang Khoa Nguyen, Pr **Phone:** 514-890-8000 **Phone Ext:** 28404 **Role:** CONTACT #### Locations **Location 1:** **City:** Montréal **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jasmine Carlier, MD - **Phone:** (+33)680891913 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Dang Khoa Nguyen, Md, PhD, Pr - **Phone:** H2X 0C1 - **Phone Ext:** 28404 - **Role:** CONTACT ***Contact 3:*** - **Name:** Dang Khoa Nguyen, Pr - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Pascal Hot, Pr - **Role:** SUB_INVESTIGATOR **Country:** Canada **Facility:** Université de Montréal's affiliated Hospital Research Centre (CRCHUM) **State:** Quebec **Zip:** H2X 0C1 #### Overall Officials **Official 1:** **Affiliation:** Université de Montréal's affiliated hospital research centre **Name:** Dang Khoa Nguyen **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available. **PMID:** 8598068 **Citation:** Lehrer P, Kaur K, Sharma A, Shah K, Huseby R, Bhavsar J, Sgobba P, Zhang Y. Heart Rate Variability Biofeedback Improves Emotional and Physical Health and Performance: A Systematic Review and Meta Analysis. Appl Psychophysiol Biofeedback. 2020 Sep;45(3):109-129. doi: 10.1007/s10484-020-09466-z. Erratum In: Appl Psychophysiol Biofeedback. 2021 Dec;46(4):389. **PMID:** 32385728 **Citation:** Laborde S, Mosley E, Thayer JF. Heart Rate Variability and Cardiac Vagal Tone in Psychophysiological Research - Recommendations for Experiment Planning, Data Analysis, and Data Reporting. Front Psychol. 2017 Feb 20;8:213. doi: 10.3389/fpsyg.2017.00213. eCollection 2017. **PMID:** 28265249 **Citation:** Pick S, Anderson DG, Asadi-Pooya AA, Aybek S, Baslet G, Bloem BR, Bradley-Westguard A, Brown RJ, Carson AJ, Chalder T, Damianova M, David AS, Edwards MJ, Epstein SA, Espay AJ, Garcin B, Goldstein LH, Hallett M, Jankovic J, Joyce EM, Kanaan RA, Keynejad RC, Kozlowska K, LaFaver K, LaFrance WC Jr, Lang AE, Lehn A, Lidstone S, Maurer CW, Mildon B, Morgante F, Myers L, Nicholson C, Nielsen G, Perez DL, Popkirov S, Reuber M, Rommelfanger KS, Schwingenshuh P, Serranova T, Shotbolt P, Stebbins GT, Stone J, Tijssen MA, Tinazzi M, Nicholson TR. Outcome measurement in functional neurological disorder: a systematic review and recommendations. J Neurol Neurosurg Psychiatry. 2020 Jun;91(6):638-649. doi: 10.1136/jnnp-2019-322180. Epub 2020 Feb 28. **PMID:** 32111637 **Citation:** Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37. **PMID:** 20526405 **Citation:** Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66. doi: 10.1097/00006842-200203000-00008. **PMID:** 11914441 **Citation:** Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. **PMID:** 2748771 **Citation:** Steinberg M, Rounsaville B, Cicchetti D. Detection of dissociative disorders in psychiatric patients by a screening instrument and a structured diagnostic interview. Am J Psychiatry. 1991 Aug;148(8):1050-4. doi: 10.1176/ajp.148.8.1050. **PMID:** 1853955 **Citation:** Loas G, Otmani O, Verrier A, Fremaux D, Marchand MP. Factor analysis of the French version of the 20-Item Toronto Alexithymia Scale (TAS-20). Psychopathology. 1996;29(2):139-44. doi: 10.1159/000284983. **PMID:** 8861519 **Citation:** Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063. **PMID:** 3397865 **Citation:** Boucsein W, Fowles DC, Grimnes S, Ben-Shakhar G, roth WT, Dawson ME, Filion DL; Society for Psychophysiological Research Ad Hoc Committee on Electrodermal Measures. Publication recommendations for electrodermal measurements. Psychophysiology. 2012 Aug;49(8):1017-34. doi: 10.1111/j.1469-8986.2012.01384.x. Epub 2012 Jun 8. **PMID:** 22680988 **Citation:** American Clinical Neurophysiology Society. Guideline 6: A proposal for standard montages to be used in clinical EEG. J Clin Neurophysiol. 2006 Apr;23(2):111-7. doi: 10.1097/00004691-200604000-00007. No abstract available. **PMID:** 16612227 #### See Also Links **Label:** Radloff LS. The CES-D scale: a self report depression scale for research in the general population. App Psycho Meas 1977;1:384-401. **URL:** http://conservancy.umn.edu/handle/11299/98561 **Label:** Paul Lehrer. Protocol for Heart Rate Variability Biofeedback Training. DOI:10.5298/1081-5937-41.3.08 **URL:** http://www.researchgate.net/publication/289937389_Protocol_for_Heart_Rate_Variability_Biofeedback_Training **Label:** Alain Leplège 2001. Le questionnaire MOS SF-36, manuel d'utilisation et guide d'interprétation des scores **URL:** http://www.researchgate.net/publication/281433197_Le_questionnaire_MOS_SF-36_manuel_d'utilisation_et_guide_d'interpretation_des_scores_French **Label:** Kathi Baron 2006 A User's Manual for the Occupational Self Assessment (OSA) : (Version 2.2) **URL:** http://search.worldcat.org/fr/title/A-User%27s-Manual-for-the-Occupational-Self-Assessment-(OSA)-:-(Version-2.2)/oclc/475547618 **Label:** C Demoulin 2017. Traduction en français du " Brief Illness Perceived Questionnaire " adapté aux patients lombalgiques et étude de ses qualités métrologiques. Doi : 10.1016/S1169-8330(16)30511-7 **URL:** http://www.em-consulte.com/article/1100188/traduction-en-francais-du-%C2%A0brief-illness-perceived **Label:** Daniel Paquette 2004. Validation de la version française du CTQ et prévalence de l'histoire de maltraitance. DOI: 10.7202/008831ar **URL:** http://www.erudit.org/fr/revues/smq/2004-v29-n1-smq755/008831ar/ ## Derived Section ### Condition Browse Module - Ancestors - 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: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M6515 - Name: Conversion Disorder - Relevance: HIGH - As Found: Functional Neurological Disorder - ID: M10096 - Name: Hysteria - Relevance: HIGH - As Found: Functional Neurological Disorder - ID: M7394 - Name: Dissociative Disorders - 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 Neurological Disorder ### Condition Browse Module - Meshes - ID: D000009422 - Term: Nervous System Diseases - 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:** NCT06422806 **Brief Title:** Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas **Official Title:** A Randomized Phase II Trial of Doxorubicin + Pembrolizumab Versus Doxorubicin Alone for the Treatment of Undifferentiated Pleomorphic Sarcoma (UPS) and Related Poorly Differentiated Sarcomas #### Organization Study ID Info **ID:** NCI-2023-06412 #### Organization **Class:** NIH **Full Name:** National Cancer Institute (NCI) #### Secondary ID Infos **Domain:** CTRP (Clinical Trial Reporting Program) **ID:** NCI-2023-06412 **Type:** REGISTRY **Domain:** ECOG-ACRIN Cancer Research Group **ID:** EA7222 **Type:** OTHER **Domain:** CTEP **ID:** EA7222 **Type:** OTHER **ID:** U10CA180820 **Link:** https://reporter.nih.gov/quickSearch/U10CA180820 **Type:** NIH ### Status Module #### Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-18 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-14 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-18 **Study First Submit QC Date:** 2024-05-18 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** NIH **Name:** National Cancer Institute (NCI) #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This phase II trial compares the effect of immunotherapy (pembrolizumab) plus chemotherapy (doxorubicin) to chemotherapy (doxorubicin) alone in treating patients with undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma that has spread from where it first started to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding immunotherapy (pembrolizumab) to the standard chemotherapy (doxorubicin) may help patients with metastatic or unresectable UPS or a related poorly differentiated sarcoma live longer without having disease progression. **Detailed Description:** PRIMARY OBJECTIVE: I. To assess whether the combination of doxorubicin and pembrolizumab will improve progression free survival (PFS) in UPS and related poorly differentiated sarcomas relative to doxorubicin alone. KEY SECONDARY OBJECTIVE: I. To assess whether the combination of doxorubicin and pembrolizumab versus (vs) the re-introduction of pembrolizumab in the doxorubicin alone arm at disease progression (i.e., upfront pembrolizumab vs second line pembrolizumab) improves overall survival (OS). SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability in each treatment arm. II. To quantify overall response rate (ORR) and durability of response (DOR) in each treatment. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive doxorubicin intravenously (IV) over 3-10 minutes or up to 3 hours on day 1 of each cycle. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive doxorubicin IV over 3-10 minutes or up to 3 hours on day 1 of each cycle. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. At time of disease progression, patients may begin receiving pembrolizumab alone IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of additional progression or unacceptable toxicity. Patients in both arms also undergo echocardiogram (ECHO) or multigated acquisition (MUGA) scan during screening, as well as standard imaging scans and blood sample collection throughout the study. After completion of study treatment, patients are followed up periodically for up to 5 years. ### Conditions Module **Conditions:** - Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 - Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 - Undifferentiated Pleomorphic Sarcoma ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 160 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients receive doxorubicin IV over 3-10 minutes or up to 3 hours on day 1 of each cycle. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO or MUGA scan during screening, as well as standard imaging scans and blood sample collection throughout the study. **Intervention Names:** - Procedure: Biospecimen Collection - Procedure: Diagnostic Imaging - Drug: Doxorubicin - Procedure: Echocardiography - Procedure: Multigated Acquisition Scan - Biological: Pembrolizumab **Label:** Arm A (doxorubicin and pembrolizumab **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients receive doxorubicin IV over 3-10 minutes or up to 3 hours on day 1 of each cycle. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. At time of disease progression, patients may begin receiving pembrolizumab alone IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of additional progression or unacceptable toxicity. Patients also undergo ECHO or MUGA scan during screening, as well as standard imaging scans and blood sample collection throughout the study. **Intervention Names:** - Procedure: Biospecimen Collection - Procedure: Diagnostic Imaging - Drug: Doxorubicin - Procedure: Echocardiography - Procedure: Multigated Acquisition Scan **Label:** Arm B (doxorubicin) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Arm A (doxorubicin and pembrolizumab - Arm B (doxorubicin) **Description:** Undergo blood sample collection **Name:** Biospecimen Collection **Other Names:** - Biological Sample Collection - Biospecimen Collected - Specimen Collection **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Arm A (doxorubicin and pembrolizumab - Arm B (doxorubicin) **Description:** Undergo standard imaging scans **Name:** Diagnostic Imaging **Other Names:** - Medical Imaging **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Arm A (doxorubicin and pembrolizumab - Arm B (doxorubicin) **Description:** Given IV **Name:** Doxorubicin **Other Names:** - Adriablastin - Hydroxydaunomycin - Hydroxyl Daunorubicin - Hydroxyldaunorubicin **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Arm A (doxorubicin and pembrolizumab - Arm B (doxorubicin) **Description:** Undergo ECHO **Name:** Echocardiography **Other Names:** - EC **Type:** PROCEDURE #### Intervention 5 **Arm Group Labels:** - Arm A (doxorubicin and pembrolizumab - Arm B (doxorubicin) **Description:** Undergo MUGA scan **Name:** Multigated Acquisition Scan **Other Names:** - Blood Pool Scan - Equilibrium Radionuclide Angiography - Gated Blood Pool Imaging - Gated Heart Pool Scan - MUGA - MUGA Scan - Multi-Gated Acquisition Scan - Radionuclide Ventriculogram Scan - Radionuclide Ventriculography - RNVG - SYMA Scanning - Synchronized Multigated Acquisition Scanning **Type:** PROCEDURE #### Intervention 6 **Arm Group Labels:** - Arm A (doxorubicin and pembrolizumab **Description:** Given IV **Name:** Pembrolizumab **Other Names:** - BCD-201 - Keytruda - Lambrolizumab - MK-3475 - Pembrolizumab Biosimilar BCD-201 - Pembrolizumab Biosimilar QL2107 - QL2107 - SCH 900475 **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Will be compared between the treatment arms (doxorubicin + pembrolizumab versus \[vs\] doxorubicin alone). The comparison of PFS between treatment arms will be done using a stratified (on Eastern Cooperative Oncology group \[ECOG\] performance status \[0 vs 1\]) log-rank test with a 5% type I error (1-sided). **Measure:** Progression free survival (PFS) **Time Frame:** From randomization to documented progression (per Response Evaluation Criteria in Solid Tumors [RECIST] version [v] 1.1 or death from any cause without prior progression, up to 5 years #### Secondary Outcomes **Description:** Will be compared between doxorubicin + pembrolizumab vs doxorubicin alone to test the strategy of upfront pembrolizumab vs second line pembrolizumab. **Measure:** Overall survival **Time Frame:** From randomization to death, up to 5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patient must be \>= 18 years of age * Patient must have a confirmed histopathologic diagnosis of undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma. Because UPS can sometimes exist in a spectrum among related diagnoses, the following additional diagnostic will be allowed, but not limited to: * Pleomorphic sarcoma with inflammation or with limited areas of differentiation * Pleomorphic sarcoma with giant cells * Malignant fibrous histiocytoma (including storiform-pleomorphic and inflammatory subtypes) * Myxofibrosarcoma, poorly differentiated sarcoma not otherwise specified (NOS) * Undifferentiated spindle cell sarcoma * Pleomorphic dermal sarcoma * Poorly differentiated spindle cell sarcoma NOS Any of these subtypes may have areas of focal myogenic differentiation * Patient must have metastatic or unresectable sarcoma * Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: * Has achieved menarche at some point * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Patient must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. Contraception measures must continue for 6 months after the last dose of doxorubicin for patients of child bearing potential and for 3 months after the last dose of doxorubicin for male patients with partners of child bearing potential. Contraception measures must also continue for 4 months after the last dose of pembrolizumab for patients of child bearing potential * Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible * Patient must have a left ventricular ejection Fraction (LVEF) \> 50% by either MUGA scan or echocardiogram obtained within 28 days prior to randomization * Absolute neutrophil count (ANC) ≥ 1,500 cells/m\^3 (must be obtained ≤ 7 days prior to protocol randomization) * Platelets ≥ 75,000 cells/m\^3 (must be obtained ≤ 7 days prior to protocol randomization) * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (must be obtained ≤ 7 days prior to protocol randomization) * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/ Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3.0 × institutional ULN (labs must be obtained ≤ 7 days prior to protocol randomization) * Creatinine ≤ 1.5 x institutional ULN or creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (labs must be obtained ≤ 7 days prior to protocol randomization) * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression * Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better * Patient must have measurable disease. Baseline imaging, including a chest CT, of all measurable and non-measurable disease must be obtained within 28 days prior to randomization * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Patient must not have had prior treatment with an anthracycline * Patient must not have a diagnosis of clinically significant immunodeficiency or an autoimmune disorder requiring the patient to use systemic steroid chronically, or systemic steroids within 7 days prior to randomization * Patient must not have a known history of active TB (Bacillus Tuberculosis) * Patient must not have a known hypersensitivity to doxorubicin or pembrolizumab or any of their excipients * Patients who have received prior chemotherapy, targeted small molecule therapy or radiation therapy must have recovered from the prior therapy at the time of randomization * Patient must have recovered adequately from any prior major surgery prior to randomization * Patient must not have received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA4 agent * Patient must not have an autoimmune or other disease that requires the use of daily corticosteroids of \> 10 mg of prednisone (or equivalent). Patients who are on an active steroid taper at the time of randomization must finish prior to beginning study treatment. Patients who require inhaled or topical steroids are eligible **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** ECOG-ACRIN Cancer Research Group **Name:** Seth M Pollack **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page. **IPD Sharing:** YES **URL:** https://grants.nih.gov/policy/sharing.htm ## Derived Section ### Condition Browse Module - Ancestors - ID: D000018204 - Term: Neoplasms, Connective and Soft Tissue - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000051642 - Term: Histiocytoma - ID: D000018218 - Term: Neoplasms, Fibrous Tissue - ID: D000009372 - Term: Neoplasms, Connective Tissue ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15327 - Name: Sarcoma - Relevance: HIGH - As Found: Sarcoma - ID: M26812 - Name: Histiocytoma, Malignant Fibrous - Relevance: HIGH - As Found: Undifferentiated Pleomorphic Sarcoma - ID: M3724 - Name: Aggression - Relevance: LOW - As Found: Unknown - ID: M26795 - Name: Histiocytoma - 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: M20364 - Name: Neoplasms, Fibrous Tissue - Relevance: LOW - As Found: Unknown - ID: M12317 - Name: Neoplasms, Connective Tissue - Relevance: LOW - As Found: Unknown - ID: T5284 - Name: Soft Tissue Sarcoma - Relevance: HIGH - As Found: Sarcoma - ID: T5790 - Name: Undifferentiated Pleomorphic Sarcoma - Relevance: HIGH - As Found: Undifferentiated Pleomorphic Sarcoma ### Condition Browse Module - Meshes - ID: D000012509 - Term: Sarcoma - ID: D000051677 - Term: Histiocytoma, Malignant Fibrous ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000082082 - Term: Immune Checkpoint Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000903 - Term: Antibiotics, Antineoplastic - ID: D000059005 - Term: Topoisomerase II Inhibitors - ID: D000059003 - Term: Topoisomerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M349416 - Name: Pembrolizumab - Relevance: HIGH - As Found: Mg/m2 - ID: M7492 - Name: Doxorubicin - Relevance: HIGH - As Found: Cognitive - ID: M227339 - Name: Liposomal doxorubicin - Relevance: HIGH - As Found: Neupogen - ID: M6832 - Name: Daunorubicin - Relevance: HIGH - As Found: Implementation - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000582435 - Term: Pembrolizumab - ID: D000004317 - Term: Doxorubicin - ID: C000506643 - Term: Liposomal doxorubicin - ID: D000003630 - Term: Daunorubicin ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422793 **Brief Title:** The Impact of Nasogastric Tube Gastric Decompression on Postoperative Nausea and Vomiting in Orthognathic Surgery **Official Title:** The Impact of Nasogastric Tube Gastric Decompression on Postoperative Nausea and Vomiting in Orthognathic Surgery #### Organization Study ID Info **ID:** 60940 #### Organization **Class:** OTHER **Full Name:** Nova Scotia Health Authority ### Status Module #### Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-31 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Nova Scotia Health Authority #### Responsible Party **Investigator Affiliation:** Nova Scotia Health Authority **Investigator Full Name:** Katherine Curry **Investigator Title:** Dr. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Postoperative nausea and vomiting (PONV) is a major concern for patients undergoing orthognathic surgery (corrective jaw surgery). These symptoms affect up to 60% of jaw surgery patients and can be quite distressing. The mechanisms underlying PONV are complex, but it is thought that surgical site bleeding and blood pooling in the stomach is the primary stimulus in this type of surgery. Nasogastric (NG) tubes have been used to suction out pooled blood in the stomach (gastric decompression), in hopes of minimizing symptoms. However, new research shows that NG tube gastric decompression may not demonstrate any benefit, and may even worsen PONV. Our study aims to directly compare PONV in participants undergoing gastric decompression or not. Participants will be randomized into two groups, either no NG tube gastric decompression or NG tube gastric decompression throughout the surgery and removed approximately one hour postoperatively. It is hypothesized that there will be less PONV in the group that does not undergo gastric decompression. We hope that the results from this study will better patient outcomes for this common postoperative problem and guide future practices for NG tube gastric decompression in orthognathic surgery. **Detailed Description:** Orthognathic surgery is a common surgical procedure performed to correct dentofacial deformities. Patients are held in maxillomandibular fixation with elastics for several weeks following surgery, limiting mouth opening during the postoperative period. Although fixation can be released, if necessary, PONV is distressing in this patient population and many patients voice concern around the idea of emesis. Patients who suffer from nausea and vomiting often have poor oral intake of fluids and analgesic medications, demonstrated by dehydration and suboptimal pain control. From a surgical perspective, vomiting puts tension on fragile oral wounds that can provoke wound dehiscence and surgical site bleeding, in turn worsening symptoms. Occasionally, PONV can necessitate increased length of stay in hospital thereby increasing costs to the healthcare system. The pathophysiology underlying nausea and vomiting is complex and multifactorial involving both centrally mediated and peripherally mediated pathways. Mechanisms that trigger emesis include, but are not limited to, activation of chemoreceptors and mechanoreceptors in the oropharynx and stomach by ingested blood and intraoperative manipulation, direct stimulation of the chemoreceptor trigger zone in the area postrema and stimulation of the glossopharyngeal and vagus nerves. In the gastrointestinal system, vagal afferents are activated by numerous emetogenic substances, of which blood is thought to be the strongest peripheral emetic stimulus. Activation of this pathway induces nausea and/or vomiting and is thought to be of particular importance in oral surgeries, specifically orthognathic surgery. Despite best hemostatic efforts with airway protection, thorough suctioning and primary wound closure, orthognathic surgery generates intraoral bleeding and ingestion of blood that is often seen in evacuated gastric contents. Gastric pooling of blood is thought to be one of the primary mechanisms by which orthognathic surgery stimulates PONV. Patient specific factors, anesthetic medications, and postoperative opioids are also thought to play key roles. In orthognathic surgery literature, prevalence of PONV is relatively high, documented at 40-60%. This is more than with general postoperative incidence of 50% for nausea and 30% for vomiting for all surgeries. Postoperative nausea and vomiting typically occur within the first 24 hours after surgery, although this is most prevalent in the first 2 hours following orthognathic surgery. This is generally considered to be early PONV, whereas delayed PONV occurs from 2 to 24 hours postoperatively. It has traditionally been believed that gastric evacuation of ingested blood using a NG tube should minimize PONV and increase patient comfort. Nasogastric tube insertion involves passing the NG tube through one nostril and maneuvering it down the oropharynx into the esophagus until adequately positioned in the stomach. It can then be hooked up to suction to remove gastric contents, a process commonly known as gastric decompression. Nasogastric tube insertion is a routine procedure that is minimally invasive, although major and minor complications have been documented in the literature. Nasogastric tube insertion has been associated with pain, tearing of the nasal mucosa, submucosal insertion, pulmonary insertion, and aspiration. Additionally, its presence can be anxiety-provoking for many patients. Several studies have previously evaluated the impact of NG tube gastric decompression on PONV for various surgical specialties. In anesthesia literature, one study looked at more than 1000 patients undergoing various surgeries and found strong evidence that the use of NG tubes does not decrease PONV. Based on this study, the routine use of NG tubes is no longer supported by the Consensus Guidelines for Management of PONV. In orthognathic surgery literature, there have been several studies with conflicting results. One retrospective study evaluated PONV in 772 orthognathic surgery patients with and without gastric suction and found that PONV was significantly worse in the group that did not have NG tube gastric decompression. Conversely, a randomized control trial evaluated PONV in 24 orthognathic surgery patients with and without gastric suction and could not associate gastric decompression with any meaningful decrease in PONV. Furthermore, another prospective study compared the incidence of PONV in 29 orthognathic surgery patients with and without NG tube gastric decompression and concluded that the presence of the NG tube instead increased the prevalence and severity of PONV. It is postulated that this may be related to stimulation of the glossopharyngeal nerve activating the gag reflex. At our institution, surgeons follow a variety of protocols for NG tube gastric decompression in orthognathic surgery. Historically, a NG tube was used in all cases, although practices have changed over the past several years. Whether a NG tube is used or not is dependent on the surgeon's expert judgement and experience. Common protocols include no NG tube and NG tube insertion at the start of surgery with intermittent suction and removal within the first hour postoperatively after transfer to the post anesthesia care unit (PACU). Our routine practices are in keeping with Canadian standards of practice. We recently conducted a survey of the Canadian Association of Oral and Maxillofacial Surgeons to better understand common practices and protocols relating to this topic. It was found 73% of respondents routinely use NG tube for gastric decompression and either remove the NG tube prior to extubation or in the PACU. The remaining 27% of respondents did not believe there is any benefit to gastric decompression and routinely do not use NG tubes for orthognathic surgery. To our knowledge, there has yet to be a randomized control trial directly comparing PONV in orthognathic surgery patients subject to these common NG tube regimens. An evidence-based protocol addressing the impact of NG tube gastric decompression in orthognathic surgery has yet to be determined. Oral and Maxillofacial Surgeons (OMFS) are using a variety of practices, including omitting NG tube gastric decompression altogether. Available literature is conflicting and some suggests that NG tube gastric decompression may worsen PONV. Further studies in this field have been recommended but not carried out to date. The aim of this study is to determine how NG tube gastric decompression impacts PONV. The results of this study will guide procedures and protocols that optimize care of this patient population at our institution, and possibly across other institutions in the future. As PONV can increase length of stay in hospital, this study may be helpful to decrease the occurrence of prolonged admission and its associated costs to the healthcare system. This research will benefit patients directly by determining a perioperative protocol to minimize PONV and may negate the need for NG tube insertion, possibly improving patient safety and outcomes. Research Question The aim of this study is to determine if nasogastric tube gastric decompression has any impact on PONV within the first 24 hours following orthognathic surgery. More specifically, this will be achieved by comparing the incidence of PONV in orthognathic surgery patients randomized into one of two study groups: A. No NG tube gastric decompression; B. NG tube insertion before surgery with intermittent suction and removal within the first hour post-operatively. Research Plan Study Arms This is a prospective study for all patients undergoing orthognathic surgery who meet inclusion criteria. Patients will be asked whether they would like to enroll in this study at their routine preadmission appointment, which typically occurs 1-2 weeks before their scheduled surgery date. Orthognathic surgery patients always require this appointment to take final measurements, models and photos that help the surgical team determine a precise final surgical plan. Another important part of this visit is reviewing the patient's past medical and surgical history, medications, allergies, smoking status, and other social history pertinent to surgery. This appointment allows ample time to thoroughly discuss our proposed study with all eligible patients and answer any questions they may have prior to consenting for enrollment. They will also be provided with a document explaining the nature of the study and will be informed they can withdraw from the study at any given time. If patients choose not to enroll, the decision around NG tube gastric decompression will be at the discretion of the surgical and anesthesia teams the day of surgery. If they do choose to enroll, their Apfel score will be calculated to determine pre-existing risk of PONV based on sex, smoking status, history of PONV or motion sickness, and use of postoperative opioid analgesics. They will be randomized into one of two study groups using a random treatment sequence determined on www.randomization.com. This randomization sequence is stratified with a 1:1(No NG: NG in at beginning of surgery and removed in PACU) allocation using random block sizes of 6 to ensure balance among groups of 14 blocks. Participants will be sequentially assigned to the next protocol group listed by the random generator at the time of enrollment. Participants will be blinded from their treatment group to minimize placebo effect, although they may later recall NG tube presence/removal if they belong in the group that gets the NG tube. Surgeons and anesthesiologists will not be blinded, as the nature of the study is not conducive to a double-blinded method. Pre-Operative and Intra-Operative Management All participants will be seen by the surgical team and the anesthesiologist the day of their surgery before being brought into the operating room. All participants receive Ibuprofen 600mg and Acetaminophen 975mg one hour pre-operatively. As all participants require nasal endotracheal intubation for orthognathic surgery, 0.1% Xylometazoline nasal spray (a topical vasoconstrictor) is administered in each nostril to minimize the likelihood of epistaxis from insertion of the nasal endotracheal tube and the NG tube, if applicable. All participants will receive a standard dose of pre-operative steroids (125-1000mg Methylprednisolone) and intravenous antibiotics (2g Cefazolin), with three doses of post-operative Cefazolin 2g IV every 8 hours. The anesthetic regimen will be determined by the attending anesthesiologist and may include total intravenous anesthetic or combined volatile and intravenous anesthesia. All participants are given a single dose of Ondansetron 4mg IV 15-30 minutes prior to completion of surgery as a prophylactic antiemetic as per anesthesia practice standards. Any given medications are documented on the Anesthesia Record accessible for later review. The surgery will be performed by one of 5 attending surgeons with a resident or fellow assist. The length of surgery often ranges from 1-3 hours depending on the procedure and its complexity. A mean arterial pressure of 60 is targeted throughout the procedure to minimize blood loss, particularly during the time of osteotomies. A throat pack is inserted and remains in place until surgery is complete to minimize the ingestion of blood from intraoral wounds. When surgery is complete, the throat pack is removed and thorough suctioning of the oropharynx using a Yankauer suction is carried out. Most patients will have an acrylic occlusal splint fixated to their maxillary orthodontic arch wire to guide their bite and are placed into maxillomandibular fixation (MMF) using a range from tight elastics to loose guiding elastics. The type of MMF depends on their pre-existing deformity, stability of the movement, surgeon preference and other patient specific factors. Participants will be assigned to their respective study arm at the time of surgery. The attending surgeon and resident /fellow will be aware of which group the participant is in and will inform the anesthesiologist before the patient is brought into the operating room. Group A: Participants in group A (No NG) will not have any intervention in the operating room. Group B: Participants in Group B will have a NG tube placed. In this group, participants will be anesthetized, intubated, and a NG tube will be inserted in the naris opposite the nasotracheal tube. A #14 French NG tube will be used, as the size allows for adequate suction while minimizing trauma on nasal passage. This measures 48 inches in length (122 cm) and is 4.7mm in diameter. Once inserted, it will be hooked up to low suction to confirm placement. If in the correct position, gastric contents will be seen in suction tubing. If no gastric contents are seen, the NG tube will be adjusted until appropriately positioned. The NG tube will be connected to suction until all stomach contents are effectively removed, as demonstrated by no new secretions in the suction tubing. The NG tube will be secured with tape throughout surgery and will be temporarily hooked back up to suction at the end of surgery to confirm its position and suction any stomach contents present. The NG tube will then be secured to the participant's nose using NG tape and will be left in place during extubation and transfer to PACU. The PACU nursing team will be asked to connect the NG tube to low intermittent suction and to complete the Study Form. The OMFS resident will complete the Study Form to document NG placement details and any complications. Post-Operative Management Orthognathic surgery patients are held in PACU for up to several hours following surgery, until they are suitable to be transferred to the inpatient unit. While in PACU, they are monitored by nursing for pain and PONV. Medications available in PACU are ordered by the attending anesthesiologist. Orders for multimodal analgesia often include acetaminophen, short-acting opioids, and long-acting opioids in keeping with routine anesthesia practice. Orders for antiemetics often include haloperidol, dimenhydrinate and ondansetron in keeping with routine anesthesia practice. While in PACU, nursing will be asked to fill out the Study Form to indicate whether the participant experienced nausea or emesis in the first 2 hours postoperatively. Episodes of nausea, vomiting, and antiemetics administered and associated time will be recorded on the Study Form. As per our routine practices, nursing will be instructed to remove the NG tube within the first hour post-operatively before transfer to the inpatient floor. Timing of removal is guided by signs and symptoms of PONV, participant comfort/ability to tolerate the tube, and quantity of gastric secretions. Once participants are transferred to the inpatient unit, their assigned nurse will be responsible for continuing completion of the Study Form. Patients are routinely ordered analgesics including Acetaminophen 650mg PO (orally) q6h (every 6 hours), Ibuprofen 600mg PO q6h, and Hydromorphone 2-4mg PO q6H as needed. Antiemetics are also available including Dimenhydrinate 25-50mg PO/IV q6h as needed and Ondansetron 4mg IV q8h as needed. All episodes of nausea, emesis and any antiemetics given with associated times will be documented on the Study Form. During morning rounds on postoperative day one, the surgical resident team will also ask the participant if they experienced nausea or emesis in the delayed postoperative period (2-24 hours postoperatively) to ensure no symptoms were missed and will document this information on the Study Form. Although most participants will not have completed a full 24-hour postoperative course at this time, this information should be representative of the delayed postoperative period. It unlikely to impact study results, as participants must not be reliant on antiemetics to manage PONV and must be tolerating adequate oral intake of fluids to meet discharge criteria from hospital. If any participant experiences delayed discharge secondary to PONV, this will be recorded on the Study Form. Patients are given post-operative instructions by an OMFS resident prior to discharge home, including instructions pertaining to management of PONV. Diet for the first several weeks is strictly liquid to allow for appropriate healing but is equally beneficial by preventing vomiting of solid foods in the postoperative period. Participants are sent home with suture scissors and are instructed that elastic MMF can be cut and released if there is ever airway concern. Under these circumstances, they are instructed to notify the OMFS resident on call and immediately proceed to the nearest emergency department. Participants are not routinely discharged with prescriptions for antiemetic medications since PONV should have largely resolved while in hospital for the patient to meet discharge criteria. If a participant has delayed discharge due to PONV, this will be considered an adverse event and will be recorded on the Study Form. Chart Review The Anesthesia Record and Progress Notes from each participant's surgery and subsequent hospital admission will be reviewed by the research team. Data collected from this review will include the type of anesthetic administered, the medication administration record, and nursing notes describing the patient's course in hospital. This information is necessary to better understand the course of PONV (if any) and to help minimize confounding variables by further evaluating study groups based on general anesthesia protocol and number of prophylactic antiemetics given. This information can only be accessed through the Nova Scotia Health Authority (NSHA) web-based application OneContent, which is password protected through NSHA Intranet. This data will be reviewed within two weeks of discharge home, once available in the OneContent system. Data Collection and Analysis Data will be obtained from pre-admission and inpatient records including the history and physical record, the anesthesia record, the intra-operative record, progress notes, study forms, and the medication administration record. Data collected will include the patient's age (years), weight (kg), sex, smoking status (smoker or non-smoker), history of PONV or motion sickness, length of time taken to insert NG tube successfully (seconds), complications arising from NG tube insertion, length of surgery (from first incision to closure), type of orthognathic surgery (LeFort, BSSO, or both), type of general anesthesia (total intravenous anesthetic vs combined volatile/ intravenous anesthetic), length of stay in hospital (hours), episodes of nausea or vomiting (yes or no) during two different time intervals (0-2 hours postoperatively and 2-24 hours postoperatively), and amount and frequency of antiemetics taken for the first 24 hours in hospital or until discharge home. This study will use descriptive statistics in the form of percentages and counts for categorical variables and means and standard deviations for continuous variables. Differences between groups will be analyzed with a chi square test. Final data analysis plan to be determined in conjunction with a biostatistician. Informed Consent Participants will be recruited and enrolled in this study during their routine preadmission appointment several days prior to their scheduled surgery. The consent discussion will be conducted by the resident completing the preoperative assessment. The resident having this discussion will have previously completed training regarding the study protocol and all aspects of the consent form. A SOP will be provided to all staff members outlining the procedures for obtaining informed consent, and all questions can be addressed at the training session or later by contacting the principal or supervising investigators. Contact information for the research team will be provided and available to all research team members. Documentation of training will be completed. Study enrollment and consent to participate will be completely voluntary and free of coercion or undue influence. Prior to consenting, all aspects of the study will be thoroughly discussed by the resident completing the assessment. The aim of this study, potential benefits and harms, group allocation and probability of assignment, expectations of participants, duration of participation, voluntariness of participation and ability to withdrawal any time will be addressed. Participants will be made aware that their surgical plan will be uninfluenced, and their care will be held to the same standard regardless of study enrollment. Potential participants will also be made aware that should they choose not to enroll in the study, the decision regarding nasogastric tube gastric decompression will be made by their surgical and anesthesia teams the day of surgery. Potential participants will be given a printed handout addressing all aspects of the study and a copy of the consent form to review. The study will be discussed in simple language, in keeping with the participant's health literacy. All questions will be answered as clearly as possible and potential participants will be given as much time as needed to decide whether to enroll. If a participant chooses to enroll, they will sign the consent form with a witness present. Participants will be made aware that they are able to withdraw from the study at any time. Participants will be given a phone number where they are able to contact the principal or supervising investigators, who will then assist them with withdrawal from the study as per their wishes. The quality of care they receive will not be affected by withdrawal from the study. Confidentiality Participants will be de-identified using a study number. No dates of birth will be recorded. Data described in the "Data Analysis" section will be obtained with only necessary information recorded. All electronic data will be stored on an encrypted, password protected NSHA computer located in a locked resident office in the Department of Oral and Maxillofacial Surgery at the Victoria General Hospital. Only research team members directly involved in patient care will have access to the office and computer. All hard copy data will be kept in a locked filing cabinet. Data will be kept for 15 years following completion of the study as per NSHA policy. When the data retention period is completed, the Director of Health Information Services will be contacted and all data will be destroyed in a way that is not recognizable, retrievable, or reconstructed. All electronic data will be wiped from the encrypted folder and computer, and all paper records will be shredded. Patient Benefits This study aims to establish an evidence-based protocol for nasogastric tube gastric decompression that can help to minimize PONV in patients undergoing orthognathic surgery. If one study arm is found to be superior to the others, future patients will benefit from their surgical team following this protocol. For study participants, potential benefits are dependent on study outcomes. The interventions proposed by this study are in keeping with routine practices at our institution. If one regimen is superior, participants in this group will benefit from decreased PONV, which is a major concern for many orthognathic surgery patients associated with suboptimal pain control, poor oral intake, increased length of stay in hospital, and poor overall experience. If the "No NG" group is found to be superior, patients in this group will benefit from not requiring insertion of the NG tube which is invasive, has potential complications, and is generally associated with patient anxiety. Patient Harms There are no hams to this study that differ from pre-existing risks for all orthognathic surgery patients. Interventions in both study arms are in keeping with current standards of practice at our institution. The decision around NG tube gastric decompression is currently decided by surgeon and anesthetist preference, which will instead be randomized for this study. As per our knowledge, to date, there has been no significant harm to patients who have not undergone NG tube gastric decompression. In case of patients experiencing PONV, the same antiemetic medications are available to both study groups. Patients are also provided with scissors and undergo teaching on how to cut MMF elastics in case of airway concern during vomiting. Patients are on a fully liquid diet, so there is little risk of aspirating any solids. For the study arm with NG tube insertion, there are potential complications associated with this procedure, including pain and epistaxis, and rarely, submucosal insertion or aspiration. Some patients may also voice anxiety around NG tube insertion. All NG tubes will be inserted when the patient is anesthetized, so they will not recall the insertion. Any complications that do arise will be recorded and managed appropriately by the surgical team. ### Conditions Module **Conditions:** - Postoperative Nausea - Postoperative Vomiting **Keywords:** - nasogastric tube - orthognathic surgery - gastric decompression ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This is a prospective study for all patients undergoing orthognathic surgery who meet inclusion criteria. If they choose to enroll, they will be randomized into one of two study groups using a random treatment sequence determined on www.randomization.com. This randomization sequence is stratified with a 1:1 (No NG: NG in at beginning of surgery and removed in PACU) allocation using random block sizes of 6 to ensure balance among groups in 14 blocks. Participants will be sequentially assigned to the next protocol group listed by the random generator at the time of enrollment. ##### Masking Info **Masking:** SINGLE **Masking Description:** Participants will be blinded from their treatment group to minimize placebo effect, although they may later recall NG tube presence/removal if they belong in the NG group. Surgeons and anesthesiologists will not be blinded, as the nature of the study is not conducive to a double-blinded method. **Who Masked:** - PARTICIPANT **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 84 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** No NG tube gastric decompression for orthognathic surgery. This group will not have a NG tube inserted. The remainder of their surgical care will be identical to the other group. PONV will be evaluated by nursing and surgical team at two time points in the 24 hour postoperative period (early \[0-2 hours\] and delayed \[2-24 hours\]). **Intervention Names:** - Procedure: No NG tube gastric decompression **Label:** No NG Gastric Decompression **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will undergo NG tube gastric decompression according to our institution's typical gastric decompression regimen. Once patients are anesthetized and intubated, and a #14 French NG tube will be inserted in the naris opposite the nasotracheal tube and hooked up to low suction to confirm placement. If in the correct position, gastric contents will be seen in suction tubing. If no gastric contents are seen, the NG tube will be adjusted accordingly. The NG tube will be connected to suction until all stomach contents are effectively removed, as demonstrated by no new secretions in the suction tubing. It will then be disconnected from suction, secured with tape throughout surgery and temporarily hooked back up to suction at the end of surgery to reconfirm position and suction stomach contents present. The NG tube will then be secured to the participant's nose and left in place during extubation and transfer to PACU. **Label:** NG Gastric Decompression **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - No NG Gastric Decompression **Description:** Participants in this group will not undergo gastric decompression following orthognathic surgery at our institution. **Name:** No NG tube gastric decompression **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The primary outcome for this study is PONV characterized by nausea and/or emesis in participants subject to one of two NG tube gastric decompression protocols during the 24-hour postoperative period. This will be characterized by indicating presence of nausea or vomiting with "yes" or "no" at two different time points (early vs delayed PONV). **Measure:** Postoperative Nausea and Vomiting **Time Frame:** Participants will be assessed for early PONV (0-2 hours postoperatively) and delayed PONV (2-24 hours postoperatively). #### Secondary Outcomes **Description:** Evaluating factors related to NG tubes including the incidence of NG tube-related complications and the length of time taken to successfully insert a NG tube. Any complications will be documented. Length of time taken to insert the tube will be recorded in seconds. This data will be described using percent for incidence and descriptive statistics. **Measure:** NG Tube Related Complications/Factors **Time Frame:** Intraoperative documentation during NG tube insertion. **Description:** Evaluate whether participants tend to experience more early (0-2h) or delayed (2-24h) PONV, increasing our understanding of possible precipitants. This will be characterized by indicating presence of nausea or vomiting with "yes" or "no" at two different time points (early \[0-2 hours postoperatively\] vs delayed \[2-24 hours postoperatively\]). **Measure:** Incidence of Early vs Delayed PONV in our Study Population **Time Frame:** Participants will be assessed for early PONV (0-2 hours postoperatively) and delayed PONV (2-24 hours postoperatively). **Description:** Gain better understanding how patient demographics, length of surgery, type of surgery, and type of general anesthesia impact PONV in our study population. Participant's age (years), sex (male or female), smoking status (smoker or non-smoker), history of PONV or motion sickness (positive or negative), length of surgery (from first incision to closure), type of orthognathic surgery (LeFort, BSSO, or both), type of general anesthesia (total intravenous anesthetic vs combined volatile/ intravenous anesthetic) will be evaluated for correlation to PONV in the 24 hour postoperative period. **Measure:** Other Factors Impacting PONV **Time Frame:** Participants will be assessed for early PONV (0-2 hours postoperatively) and delayed PONV (2-24 hours postoperatively). **Description:** Evaluating whether Apfel scores correlate to PONV and can function as an accurate predictor of PONV in our study population.The Apfel score (0-4) will be documented for each patient. Apfel score means for groups experiencing nausea and/or vomiting will be compared to Apfel score means for participants who do not experience nausea and/or vomiting. **Measure:** Apfel Score as a Predictor of PONV in our Study Population **Time Frame:** Apfel score will be determined preoperatively. Participants will be assessed for early PONV (0-2 hours postoperatively) and delayed PONV (2-24 hours postoperatively). ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients over the age of 16 undergoing orthognathic surgery for the correction of dentofacial deformities at the Victoria General Hospital during the study period. Orthognathic surgery to include: 1. Patients who receive single-jaw surgery (i.e. BSSO \[Bilateral Sagittal Split Osteotomy\] only, or LeFort only). 2. Patients receiving double-jaw surgery (i.e. BSSO and LeFort). 3. Patients undergoing a functional genioplasty in addition to another osteotomy (i.e. BSSO and/or LeFort). Exclusion Criteria: * Patients will be excluded if they do not meet inclusion criteria or if they have risk factors known to directly impact PONV and/or cause delayed gastric emptying: 1. Patients under the age of 16 at the time of surgery. 2. Patients contraindicated to undergo elective surgery, including pregnant patients. 3. Patients undergoing a functional genioplasty procedure only. 4. Patients with a history of vertigo or migraines. 5. Patients taking Semaglutide (Ozempic). 6. Patients with known diabetic gastroparesis. **Healthy Volunteers:** True **Minimum Age:** 16 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Katherine A Curry, DDS **Phone:** 9024732070 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** NSHA **Name:** Katherine A Curry, DDS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** This data will be anonymous. Participants will only be consenting to participate in this study. There is no future studies planned using this study data. **IPD Sharing:** NO ### References Module #### References **Citation:** Koivuranta M, Laara E, Snare L, Alahuhta S. A survey of postoperative nausea and vomiting. Anaesthesia. 1997 May;52(5):443-9. doi: 10.1111/j.1365-2044.1997.117-az0113.x. **PMID:** 9165963 **Citation:** Becker DE. Nausea, vomiting, and hiccups: a review of mechanisms and treatment. Anesth Prog. 2010 Winter;57(4):150-6; quiz 157. doi: 10.2344/0003-3006-57.4.150. **PMID:** 21174569 **Citation:** Ghosh S, Rai KK, Shivakumar HR, Upasi AP, Naik VG, Bharat A. Incidence and risk factors for postoperative nausea and vomiting in orthognathic surgery: a 10-year retrospective study. J Korean Assoc Oral Maxillofac Surg. 2020 Apr 30;46(2):116-124. doi: 10.5125/jkaoms.2020.46.2.116. **PMID:** 32364351 **Citation:** Fortier J, Chung F, Su J. Unanticipated admission after ambulatory surgery--a prospective study. Can J Anaesth. 1998 Jul;45(7):612-9. doi: 10.1007/BF03012088. **PMID:** 9717590 **Citation:** Kovac AL. Prevention and treatment of postoperative nausea and vomiting. Drugs. 2000 Feb;59(2):213-43. doi: 10.2165/00003495-200059020-00005. **PMID:** 10730546 **Citation:** Apipan B, Rummasak D, Wongsirichat N. Postoperative nausea and vomiting after general anesthesia for oral and maxillofacial surgery. J Dent Anesth Pain Med. 2016 Dec;16(4):273-281. doi: 10.17245/jdapm.2016.16.4.273. Epub 2016 Dec 31. **PMID:** 28879315 **Citation:** Zhong W, Shahbaz O, Teskey G, Beever A, Kachour N, Venketaraman V, Darmani NA. Mechanisms of Nausea and Vomiting: Current Knowledge and Recent Advances in Intracellular Emetic Signaling Systems. Int J Mol Sci. 2021 May 28;22(11):5797. doi: 10.3390/ijms22115797. **PMID:** 34071460 **Citation:** Dobbeleir M, De Coster J, Coucke W, Politis C. Postoperative nausea and vomiting after oral and maxillofacial surgery: a prospective study. Int J Oral Maxillofac Surg. 2018 Jun;47(6):721-725. doi: 10.1016/j.ijom.2017.11.018. Epub 2018 Jan 1. **PMID:** 29301675 **Citation:** Silva AC, O'Ryan F, Poor DB. Postoperative nausea and vomiting (PONV) after orthognathic surgery: a retrospective study and literature review. J Oral Maxillofac Surg. 2006 Sep;64(9):1385-97. doi: 10.1016/j.joms.2006.05.024. **PMID:** 16916674 **Citation:** Apfel CC, Roewer N. Risk assessment of postoperative nausea and vomiting. Int Anesthesiol Clin. 2003 Fall;41(4):13-32. doi: 10.1097/00004311-200341040-00004. No abstract available. **PMID:** 14574212 **Citation:** Laskin DM, Carrico CK, Wood J. Predicting postoperative nausea and vomiting in patients undergoing oral and maxillofacial surgery. Int J Oral Maxillofac Surg. 2020 Jan;49(1):22-27. doi: 10.1016/j.ijom.2019.06.016. Epub 2019 Jun 21. **PMID:** 31230771 **Citation:** Pourtaheri N, Peck CJ, Maniskas S, Park KE, Allam O, Chandler L, Smetona J, Yang J, Wilson A, Dinis J, Lopez J, Steinbacher DM. A Comprehensive Single-Center Analysis of Postoperative Nausea and Vomiting Following Orthognathic Surgery. J Craniofac Surg. 2022 Mar-Apr 01;33(2):584-587. doi: 10.1097/SCS.0000000000008052. **PMID:** 34510064 **Citation:** Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramer MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002. Erratum In: Anesth Analg. 2014 Mar;118(3):689. Anesth Analg. 2015 Feb;120(2):494. **PMID:** 24356162 **Citation:** Sanaie S, Mahmoodpoor A, Najafi M. Nasogastric tube insertion in anaesthetized patients: a comprehensive review. Anaesthesiol Intensive Ther. 2017;49(1):57-65. doi: 10.5603/AIT.a2017.0001. Epub 2017 Jan 13. **PMID:** 28084614 **Citation:** Kerger KH, Mascha E, Steinbrecher B, Frietsch T, Radke OC, Stoecklein K, Frenkel C, Fritz G, Danner K, Turan A, Apfel CC; IMPACT Investigators. Routine use of nasogastric tubes does not reduce postoperative nausea and vomiting. Anesth Analg. 2009 Sep;109(3):768-73. doi: 10.1213/ane.0b013e3181aed43b. **PMID:** 19690245 **Citation:** Wang J, Zhang Z. Gastric Negative Pressure Suction Method Reduces the Incidence of PONV after Orthognathic Surgery. Front Surg. 2022 May 20;9:882726. doi: 10.3389/fsurg.2022.882726. eCollection 2022. **PMID:** 35669253 **Citation:** Schmitt ARM, Ritto FG, de Azevedo JGRL, Medeiros PJD, de Mesquita MCM. Efficacy of Gastric Aspiration in Reducing Postoperative Nausea and Vomiting After Orthognathic Surgery: A Double-Blind Prospective Study. J Oral Maxillofac Surg. 2017 Apr;75(4):701-708. doi: 10.1016/j.joms.2016.10.002. Epub 2016 Oct 12. **PMID:** 27816732 **Citation:** Maza, C., López, A. M., Kulyapina, A., Leno, B., Tousidonis, M., Garcia, A. & Salmerón, J. I. (2013). Orthognathic surgery: nasogastric tube responsible of the nausea and vomiting?. International Journal of Oral and Maxillofacial Surgery, 42(10), 1333. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012817 - Term: Signs and Symptoms, Digestive - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M17582 - Name: Vomiting - Relevance: HIGH - As Found: Vomiting - ID: M22074 - Name: Postoperative Nausea and Vomiting - Relevance: HIGH - As Found: Postoperative Nausea - ID: M12273 - Name: Nausea - Relevance: HIGH - As Found: Nausea - ID: M15622 - Name: Signs and Symptoms, Digestive - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009325 - Term: Nausea - ID: D000014839 - Term: Vomiting - ID: D000020250 - Term: Postoperative Nausea and Vomiting ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422780 **Brief Title:** Comparison of Maternal Role Preparation and Awareness-Centred Occupational Therapy Trainings in Pregnant Women **Official Title:** Comparison of Maternal Role Preparation and Awareness-Centred Occupational Therapy Trainings in Pregnant Women: Randomised Controlled Trial With Postpartum Follow-up #### Organization Study ID Info **ID:** HÜ-ERG-AK-01 #### Organization **Class:** OTHER **Full Name:** Çankırı Karatekin University ### Status Module #### Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-03 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Çankırı Karatekin University #### Responsible Party **Investigator Affiliation:** Çankırı Karatekin University **Investigator Full Name:** Aysenur KARAKUS **Investigator Title:** Lecturer **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 was to compare maternal role preparation and mindfulness-centred occupational therapy trainings in pregnant women: a randomised controlled trial with postpartum follow-up. **Detailed Description:** Pregnancy and postpartum are a major change and crisis process for women. Women undergo hormonal, vascular, anatomical, physiological, and psychological changes for 40 weeks to meet the biochemical needs of the developing fetus, maintain homeostasis, and prepare for childbirth and lactation. These changes occurring during pregnancy are necessary to protect the health of mother and baby, as well as to prepare women for childbirth and maternity. Psychological changes that vary from trimester to trimester, accompanied by physiological changes in pregnancy. Especially in the second and third trimester, changes in the biopsychosocial balance, affecting family and work roles, taking on new responsibilities, trying to adapt to new roles and meeting the baby increased perceived depression, anxiety and stress. These physiological and psychological symptoms during pregnancy have been to adversely affect the quality of life of pregnant women. In literature, participation in meaningful and purposeful activities, which is an important indicator of quality of life, is also believed to have an impact on occupational performance during pregnancy. During pregnancy, post-partum and postpartum, the mother is expected to adapt to the physiological and psychological changes she experiences, to be able to take care of herself and her baby, to play the role of mother and to accept her baby. Physical activity levels, sleep and quality of life during pregnancy are also likely to be affected by maternal role adaptation and participation in social life. In this context, it should be taken into account that the period of pregnancy is an important milestone for the end of childbirth and the postpartum period. Postpartum physical problems occur in 70% of women, while 17% of women are accompanied by emotional problems.Especially in the postpartum period, emotional changes have been to occur in between 24% and 89% of women with post-partum depression (PPD), between 40% and 50% of mothers and between 9% and 30% of female with anxiety. Emotional problems can also arise as a result of a mother's physical problems, such as providing baby care, creating a safe environment for the baby, communicating with the child, learning new roles, developing family sensitivity, and dealing with problems related to the baby. Therefore, the postpartum period can become a crisis life for the family, just like pregnancy.Physical and emotional symptoms may adversely affect family, work, and social life, thereby reducing quality of life. (14,15,24). Physical and emotional symptoms have also been to negatively affect the maternal bond between the mother and the baby, the mother's sense of self, occupational balance, and occupational performance. Occupational Theraphy is a health care profession that supports an individual's ability to sustain occupational performance through various interventions and person-centric practices, helping the individual to adapt to changes that are constantly encountered within and around him. In this context, one of the interventions used to enhance pregnancy coherence is maternal role preparation training. Maternal role preparation is an occupational training that focuses on improving motherhood competence and living a successful role-to-mother harmony when the mother becomes a mother for the first time. One of the other interventions used in occupational therapy is a person-centric occupation therapy. In today's occupational therapy interventions, person-centric practices have always been a key element. With a person-centric approach, consultants and therapists work together to identify the nature of their occupational performance problems, the focus and need of the intervention, and the consequences of the preferred treatment. In this context, the study was planned to study tangible behavioral changes resulting from interventions in healthy pregnant women and their impact on participation in daily life activities. Our study aims to study the effectiveness of maternal role preparation training and awareness-based occupational therapy and post-partum follow-up. This study is important for the continuation of valuable activities and roles within pregnant women's daily routines, for the development of new strategies to make them feel better during pregnancy, and for a clinically integrated approach. ### Conditions Module **Conditions:** - Pregnancy Related - Postpartum Complication **Keywords:** - pregnancy - postpartum period - occupational therapy - quality of life ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** Randomised controlled trial with follow-up ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 66 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Pregnant women in the second trimester (14-27th week) will be included in the trainings. **Intervention Names:** - Other: Maternal Role Preparation Training **Label:** Maternal Role Preparation Training Group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Pregnant women in the second trimester (14-27th week) will be included in the trainings. **Intervention Names:** - Other: Awareness Centred Occupational Therapy Group **Label:** Awareness Centred Occupational Therapy Group **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Pregnant women in the second trimester (14-27th week) will be included in the trainings. **Label:** Control Group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Maternal Role Preparation Training Group **Description:** Maternal Role Preparation Training: Maternal Role Preparation Training (MRHE) is an occupational training programme aimed at increasing the competence of first-time mothers regarding motherhood. In this four-session programme, pregnant women will be provided with written materials, face-to-face talks and practical training covering topics related to their babies (maternal attachment, training on the sensory and developmental abilities of babies) and themselves (training on adopting a new role as a mother).The sessions will be applied 2 days a week, each session 1 hour, a total of 8 weeks-16 sessions. **Name:** Maternal Role Preparation Training **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Awareness Centred Occupational Therapy Group **Description:** Awareness Centred Occupational Therapy (FME); In FME, areas that affect the occupational performance of pregnant women in their daily lives will be identified and appropriate occupational therapy interventions will be applied. Awareness training on the applications will be given before starting the sessions. The sessions will be applied 2 days a week, each session 1 hour, a total of 8 weeks-16 sessions. Awareness training will be given before starting the sessions. **Name:** Awareness Centred Occupational Therapy Group **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The Nottingham Health Profile will be used to assess the awareness of pregnant women about their own health status. The Nottingham Health Profile assesses self-perceived health status and includes subsections on pain, emotional reactions, sleep, social isolation, physical activity and energy. These sub-sections make up the more intensively used section 1, while work life, household chores, social life, home life, sexual life, interests and holidays make up section 2. Each section is scored on a scale of 0-100. In the sections consisting of questions answered yes and no, the highest score can be 0 and the lowest score can be 100 (40,41). Turkish adaptation was performed by Küçükdeveci et al. in 1997. **Measure:** Nothingham Health Profile(NHP) **Time Frame:** 3 weeks #### Secondary Outcomes **Description:** Physical, demographic and obstetric information of pregnant women will be recorded. In the physical information section, the height (m), body weight (kg) before pregnancy and at the time of assessment will be recorded. In the demographic information section, the age, marital status ("married" and "single"), educational status of the pregnant woman and the father, employment status ("working" and "not working") and occupation of the pregnant woman and the father will be questioned. Educational status will be recorded categorically as "only literate", "primary school", "secondary school", "high school", "associate degree", "bachelor's degree", "master's degree" and "doctorate" **Measure:** Demographic Data Form **Time Frame:** 1 weeks **Description:** The validity and reliability study of the Turkish version, developed by Wagman and Hakansson (2012), was carried out by Günal et al. (2019). The test-re-test reliability ratio for the Turkish version of the scale was 0.922, with the Cronbach alpha value being 0.785. The room is a self-reporting scale that evaluates a person's occupational balance in different dimensions. It is used to measure the satisfaction a person receives from the number and variety of daily activities and to determine the occupational balance based on the results obtained. The scale consists of 11 items rated at a 4-point range ranging from 0 (I totally disagree) to 3 (I absolutely agree). The scale's total score is the sum of the individual scores given to the questions and ranges from 0-33. High scores indicate a better occupational balance. **Measure:** Occupational Balance Questionnaire(OBQ11-T) **Time Frame:** 3 weeks **Description:** Time management of individuals will be evaluated by Time Management Questionnaire (TMQ) consisting of 27-items. Developed by Britton and Tesser (1991), Alay and Koçak (2002) conducted a Turkish reliability and validity study. The reliability coefficient calculated by Cronbach's alpha correlations was found to be 0.88 for Time Planning, 0.66 for Time Attitudes subscale and 0.87 for the whole scale. The ATI is an inventory with 3 subscales: 16-item Time Planning, 7-item Time Attitudes and 4-item Time Spenders. Each item is scored out of 5 and a five-point scale consisting of "always, often, sometimes, rarely and never" options is formed. In scoring, 5 is given to the answer at the end of the scale, while 1 is given to the answer on the other side of the scale. The maximum score that can be obtained from the RIQ is 135 and the minimum score is 27. **Measure:** Time Management Questionnaire(TMQ) **Time Frame:** 3 weeks **Description:** Hospital Anxiety and Depression Scale (HADS): HAD was developed by Zigmond and Snaith (47) in 1983. Turkish validity and reliability of the scale was performed by Aydemir in 1997. The scale consists of 14 items. Odd numbered items in the scale investigate anxiety and even numbered items investigate depression. Seven items measure anxiety and seven items measure depression. In the Turkish validity and reliability study of the scale, the cronbach alpha coefficient was found to be 0.85 for the anxiety subscale and 0.77 for the depression subscale. In this study, the cronbach alpha values of the scale sub-dimensions were found to be 0.88 for the anxiety sub-dimension and 0.79 for the depression sub-dimension. **Measure:** The Hospital Anxiety and Depression Scale(HADS) **Time Frame:** 3 weeks **Description:** It was developed by Garnefski, Kraaij, and Spinhoven (2001) and adapted into Turkish by Tuna and Bozo (2012) (50, 51). When the scale was analysed in terms of reliability, Cronbach's alpha coefficients of the subscales ranged between .68 and .86 in various populations. The five-point Likert-type scale (1= almost never, 2= rarely, 3= sometimes, 4= often, 5= almost always) consists of a total of 36 items. Each subscale consists of four items representing different emotion regulation strategies: self-blame, acceptance, rumination, perspective taking, positive refocusing, planning refocusing, positive reappraisal, catastrophising and blaming others. Subscale scores are obtained by summing the item scores corresponding to the relevant subscale and each subscale receives a score between 4 and 20. Higher scores on the subscales indicate a higher frequency of using the relevant emotion regulation strategy. **Measure:** The Cognitive Emotion Regulation Questionnaire **Time Frame:** 3 weeks **Description:** It is a 4-point Likert-type scale that evaluates individuals' coping styles with stress (44, 45). This scale was developed by Folkman and Lazarus (1988) and Turkish reliability and validity study was conducted by Şahin and Durak (1995). Cronbach alpha internal consistency coefficients were reported to be between 0.49-0.68 for optimistic approach, 0.62-0.80 for self-confident approach, 0.64-0.73 for helpless approach, 0.47-0.72 for submissive approach and 0.45-0.47 for social support seeking factor. SBSAS consists of 5 factors: self-confident approach, helpless approach, submissive approach, optimistic approach and seeking social support. The scale is a 5-point Likert-type self-report scale consisting of 31 items. The scale includes a metric measurement from "I Never Use" (0) to "I Always Use" (4). The scores obtained from the scale vary between 0-124. **Measure:** Coping Style Scales **Time Frame:** 3 weeks **Description:** The pain intensity of the pregnant women was questioned with a 10 cm visual analogue scale (VAS). In this scale, the beginning of the line indicates "no pain" (score 0) and the end of the line indicates "unbearable pain" (score 10). Pregnant women will be asked to mark the intensity of the pain they feel on the VAS. The marked point will be measured with a ruler and the results will be recorded in cm. **Measure:** Visual Pain Scale(VPS) **Time Frame:** 3 weeks **Description:** The degree of sleep problems of the pregnant women will be evaluated using a VAS consisting of a 10 cm line. On this 10 cm line, the pregnant women will be told that the point "0" means that there is no problem with sleep and the point "10" means a very severe sleep problem and they will be asked to mark their sleep problems on this line. The marking point will be measured with the help of a ruler and the value obtained will be recorded in cm. In addition, the total amount of sleep of the pregnant women and how much sleep they wake up at night will be questioned in hours. **Measure:** Visual Sleep Scale(VSS) **Time Frame:** 3 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion criteria for pregnant women: * 18 to 35 years of age * Having conceived naturally * Being between 14-27 weeks of gestation * To be literate * Being primiparous * Reading and understanding Turkish * Volunteering to participate in the study * To have attended 80% of the trainings given Inclusion criteria for women in the postpartum period: * Giving birth at term * Having a healthy newborn (newborn born at 38-42 weeks of gestation, without low birth weight, without any disease) * Providing active care to the newborn baby with or without assistance Exclusion criteria for pregnant women * Having a risky pregnancy (gestational diabetes, eclampsia, pre-eclampsia, threatened preterm birth, premature rupture of membranes, placental anomalies etc.) * Having a maternal physical anomaly * Communication difficulties and mental deficiency * Having a medical history of mental illness * Having a foetal abnormality during pregnancy * Having a disease/complication that developed during pregnancy Exclusion criteria for women in the postpartum period: * Experiencing a traumatic event within 6-8 weeks postpartum (loss/death of a close person, natural disasters, accident, assault) * Stillbirth or having a baby with anomalies * Having a baby that requires an intensive care environment in a hospital * Mothers diagnosed with psychiatric illness (schizophrenia, depression, anxiety, panic attacks) **Healthy Volunteers:** True **Maximum Age:** 35 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Aysenur KARAKUS, MSc **Phone:** +90 5073663434 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Gokcen+ AKYUREK, Assoc Prof **Role:** CONTACT #### Locations **Location 1:** **City:** Çankırı **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Aysenur Karakus KARAKUŞ, MSc - **Phone:** +90 376 218 95 00 - **Role:** CONTACT ***Contact 2:*** - **Name:** Gokcen Akyurek, Assoc Prof - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Turkey **Facility:** Çankırı Karatekin University Occupational Therapy Department **Status:** RECRUITING **Zip:** 18100 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422767 **Brief Title:** Study to Evaluate the Effect of Bepirovirsen on Cardiac Conduction as Assessed by 12-lead Electrocardiogram in Healthy Volunteers **Official Title:** A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Bepirovirsen on Cardiac Conduction as Assessed by 12-lead Electrocardiogram in Healthy Volunteers #### Organization Study ID Info **ID:** 205873 #### Organization **Class:** INDUSTRY **Full Name:** GlaxoSmithKline ### Status Module #### Completion Date **Date:** 2024-10-08 **Type:** ESTIMATED #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-20 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-03 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** PPD **Class:** INDUSTRY **Name:** Laboratory Corporation of America #### Lead Sponsor **Class:** INDUSTRY **Name:** GlaxoSmithKline #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study will evaluate the effect of a single dose of bepirovirsen on the QT interval corrected by Fridericia's formula (QTcF) as compared to placebo. The data generated will be used to model the relationship between bepirovirsen concentration and QTcF. ### Conditions Module **Conditions:** - Hepatitis B **Keywords:** - Bepirovirsen - Cardiac Conduction - Electrocardiogram - QT interval corrected by Fridericia's formula - Hepatitis B virus ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Masking Description:** This will be a double-blind study. **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Bepirovirsen **Label:** Participants receiving Bepirovirsen **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Placebo **Label:** Participants receiving Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Participants receiving Bepirovirsen **Description:** Bepirovirsen will be administered. **Name:** Bepirovirsen **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Participants receiving Placebo **Description:** Placebo will be administered. **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Change from Baseline in QT interval corrected by Fridericia's formula (QTcF) **Time Frame:** Baseline (Day 1) and up to Day 4 #### Secondary Outcomes **Measure:** Change from Baseline in heart rate (HR) using by-time point analysis **Time Frame:** Baseline (Day 1) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose **Measure:** Change from Baseline in QT interval, corrected by Fridericia's formula (QTcF), using by-time point analysis **Time Frame:** Baseline (Day 1) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose **Measure:** Change from Baseline in PR interval using by-time point analysis **Time Frame:** Baseline (Day 1) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose **Measure:** Change from Baseline in QRS duration using by-time point analysis **Time Frame:** Baseline (Day 1) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose **Measure:** Number of participants with outlier results for QT interval, corrected by Fridericia's formula (QTcF), HR, PR and QRS **Time Frame:** Up to Day 4 **Measure:** Number of participants with treatment emergent changes of T wave morphology and U-wave presence **Time Frame:** Up to Day 4 **Measure:** Plasma concentrations of Bepirovirsen **Time Frame:** Up to Day 4 **Measure:** Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-infinity]) of Bepirovirsen **Time Frame:** Up to Day 4 **Measure:** Area under the concentration-time curve from time zero (pre-dose) to 24 hours post-dose (AUC[0-24]) of Bepirovirsen **Time Frame:** Up to 24 hours **Measure:** Maximum concentration (Cmax) of Bepirovirsen in plasma **Time Frame:** Up to Day 4 **Measure:** Time to reach Cmax (Tmax) of Bepirovirsen **Time Frame:** Up to Day 4 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent. * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, Electrocardiogram (ECGs) and vital signs. * Body weight greater than equal to (\>=) 50 Kilograms (kg) and Body mass index (BMI) within the range 19-32 Kilograms per square meter (kg/m\^2) (inclusive). * Male Participants: There are no contraceptive requirements for male participants. * A female participant is eligible to participate: * if she is not pregnant or breastfeeding and 1 of the following conditions applies: 1. is a woman of non-childbearing potential (WONCBP). OR 2. is a WOCBP and using a contraceptive method. * Capable of giving signed informed consent. Exclusion Criteria: * History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data. * History of vasculitis or presence of symptoms and signs of potential vasculitis * A sustained supine systolic blood pressure greater than (\>)150 millimeters of mercury (mmHg) or less than (\<)90 mmHg or a supine diastolic blood pressure \>95 mmHg or \<50 mmHg at Screening or Check-in (Day -2). * Lymphoma, leukemia, or any malignancy except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. * Participants with any other medical conditions which, in the judgement of the investigator and/or Medical Monitor, could jeopardize the integrity of the data derived from that participant or the safety of the participant. * Platelets \<140 x 10\^9 cells/liter (L). * Serum calcium, magnesium or potassium levels outside the normal reference range at screening. * Past, current or intended use of over-the-counter or prescription medication, including herbal medications within 7 days or 5 half-lives (whichever is longer) before dosing. * Current or prior use of creatine-containing supplements, or intended use up to 50 days post-dosing. * Prior treatment with any oligonucleotide or small interfering Ribonucleic acid (RNA) (siRNA) within 12 months before dosing. * Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day * Current enrollment or past participation in another investigational study in which an investigational intervention (e.g., drug, vaccine, invasive device) was administered within 5 half-lives (if known) or twice the duration of biological effect (if known), whichever is longer, or within the last 90 days (if half-life and duration of biological effect are unknown), before signing of consent in any other clinical study involving an investigational study intervention or any other type of medical research. * Current enrollment or past participation in this clinical study. * Positive pre-clinical drug/alcohol screen, including Tetrahydrocannabinol (tetrahydrocannabinol). * Positive Human Immunodeficiency Virus antibody test. * Cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening. * Regular alcohol consumption within 6 months prior to screening defined as an average weekly intake of \>14 units for males or females. * Regular use of known drugs of abuse, including tetrahydrocannabinol. * Sensitivity to heparin or history of heparin-induced thrombocytopenia. * History of sensitivity to bepirovirsen or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor contraindicates their participation. * Alanine aminotransaminase (ALT) \>1.5x Upper Limit of Normal (ULN). * Total bilirubin \>1.5xULN; Participants with Gilbert's syndrome can be included with total bilirubin \>1.5x ULN as long as direct bilirubin is less than equal to (\<=) 1.5xULN. * Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * Presence of Hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention. * Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention. * Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention. * Known history of heart disease, including ischemic heart disease, cardiomyopathy, clinically significant cardiac arrhythmias, clinically significant valvular disease, or hypertensive heart disease. 1. History of palpitations associated with presyncope or syncope, or history of unexplained syncope. 2. History of Brugada syndrome, ventricular pre-excitation syndromes, personal or family history of long QT syndrome, or family history of sudden cardiac death. * Exclusion criteria for Screening ECG: 1. A supine mean heart rate outside the range 50 to 100 beats per minute (bpm). A HR from 100 to 110 bpm can be rechecked by ECG or vital signs within 2 hours to verify eligibility. 2. QT interval corrected by Fridericia's formula (QTcF) \>450 milliseconds (msec). 3. QRS interval \>120 msec 4. PR interval \>210 msec 5. An uninterpretable ECG or any significant arrhythmia or conduction abnormality which, in the opinion of the investigator or GlaxoSmithKline (GSK) Medical Monitor, will interfere with the safety of the individual participant. **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** US GSK Clinical Trials Call Center **Phone:** 877-379-3718 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** EU GSK Clinical Trials Call Center **Phone:** +44 (0) 20 89904466 **Role:** CONTACT #### Locations **Location 1:** **City:** Austin **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Brian Spears - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** GSK Investigational Site **State:** Texas **Zip:** 78744 ### IPD Sharing Statement Module **Access Criteria:** Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months. **Description:** Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/ **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES **Time Frame:** Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications. **URL:** https://www.gsk.com/en-gb/innovation/trials/data-transparency/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008107 - Term: Liver Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000006525 - Term: Hepatitis, Viral, Human - ID: D000014777 - Term: Virus Diseases - ID: D000007239 - Term: Infections - ID: D000086982 - Term: Blood-Borne Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000018347 - Term: Hepadnaviridae Infections - ID: D000004266 - Term: DNA Virus Infections ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M9592 - Name: Hepatitis A - Relevance: LOW - As Found: Unknown - ID: M9591 - Name: Hepatitis - Relevance: HIGH - As Found: Hepatitis - ID: M9595 - Name: Hepatitis B - Relevance: HIGH - As Found: Hepatitis B - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M9610 - Name: Hepatitis, Viral, Human - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M2593 - Name: Blood-Borne Infections - Relevance: LOW - As Found: Unknown - ID: M20487 - Name: Hepadnaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M7442 - Name: DNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: T2787 - Name: Herpes Simiae (B Virus) - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006509 - Term: Hepatitis B - ID: D000006505 - Term: Hepatitis ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422754 **Brief Title:** THE EFFECT OF VIRTUAL REALITY APPLICATIONS ON SITTING BALANCE IN HEMIPLEGIA: A RANDOMIZED CONTROLLED STUDY **Official Title:** THE EFFECT OF VIRTUAL REALITY APPLICATIONS ON SITTING BALANCE IN HEMIPLEGIA: A RANDOMIZED CONTROLLED STUDY #### Organization Study ID Info **ID:** GaziosmanpasaTREH-FTR-EK-01 #### Organization **Class:** OTHER_GOV **Full Name:** Gaziosmanpasa Research and Education Hospital ### Status Module #### Completion Date **Date:** 2024-08-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-08-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-29 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Gaziosmanpasa Research and Education Hospital #### 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:** Objective: The aim of this study was to investigate the effects of virtual reality application on quality of life and functionality, especially sitting balance, in hemiplegic patients. **Detailed Description:** This study was planned as a single-blind randomized controlled prospective study. Patients over 18 years of age with a diagnosis of hemiplegia who applied to Gaziosmanpaşa Training and Research Hospital PTR outpatient clinic and were hospitalized in the rehabilitation service and started a rehabilitation program; will be evaluated with Modified Ashworth, Tardiue Scale, Brunstrom assessment, Stroke Specific Quality of Life Scale, Beck Anxiety Scale, Functional Independence Scale, Mini Mental State Test (MMDT), Mini Mental Test for the Uneducated, Postural Assessment Scale in Stroke Patients, Rivermead Motor Assessment Scale, Sitting Function Test, Berg Balance Scale, System Usability Scale before and after the program. Patients who apply to the rehabilitation program will be randomly selected by closed envelope method. The first group will receive conventional rehabilitation program and home program. Conventional exercises\* of the first group will be performed for 30 sessions of 1 hour every day, in addition to this, the patient will be given a home program. In the second group, conventional exercises will be performed for 30 sessions of 1 hour every day. In addition to conventional exercises, this group will be enrolled in a balance game group using the Becure Balance System application and the WI balance board for 45 minutes 5 sessions a week.The necessary software and equipment for the virtual reality program were donated by Becure GmbH. Both groups will be reassessed after 30 sessions. The physician performing the evaluation will be completed blindly by physiotherapists who apply the conventional exercises and the virtual reality program. The study is a single-center clinical study using prospective data. Between 01.05.2024-01.08.2024, 36 patients are planned to be enrolled in the study. \*:Conventional exercise therapy includes range of motion, stretching, strengthening and balance exercises in patients with hemiplegia. ### Conditions Module **Conditions:** - Hemiplegia **Keywords:** - virtual reality - hemiplegia - sitting balance ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The first group will receive 30 sessions of conventional exercises for 1 hour every day. In addition, the patient will be given a home program. **Intervention Names:** - Device: Becure GmbH **Label:** Conventional Group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** In the second group, conventional exercises will be applied for 1 hour and 30 sessions every day. In addition to conventional exercise, this group will be enrolled in the balance game group using the Becure Balance System application and Wİ balance board for 45 minutes 5 sessions a week. **Intervention Names:** - Device: Becure GmbH **Label:** Virtual Reality Group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Conventional Group - Virtual Reality Group **Description:** Becure Balance System **Name:** Becure GmbH **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone. **Measure:** modified ashworth scale **Time Frame:** 1 month **Description:** The Brunnstrom recovery stages (BRS) is a short and easily administered measure for assessing motor function. **Measure:** Brunnstrom Stages **Time Frame:** 1 month **Description:** The QOLS was originally a 15-item instrument that measured five conceptual domains of quality of life: material and physical well-being, relationships with other people, social, community and civic activities, personal development and fulfillment, and recreation. **Measure:** stroke-specific quality of life **Time Frame:** 1 month **Description:** The Beck Anxiety Inventory (BAI) consists of 21 self-reported items (four-point scale) used to assess the intensity of physical and cognitive anxiety symptoms during the past week. Scores may range from 0 to 63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63). **Measure:** beck anxiety inventory **Time Frame:** 1 month **Description:** The instrument includes measures of independence for self-care, including sphincter control, transfers, locomotion, communication, and social cognition. **Measure:** The Functional Independence Measure **Time Frame:** 1 month **Description:** The maximum score for the MMSE is 30. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment. **Measure:** mini mental state examination **Time Frame:** 1 month **Description:** It contains 12 four-level items of varying difficulty for assessing ability to maintain or change a given lying, sitting or standing posture. **Measure:** Postural Assessment Scale for Stroke **Time Frame:** 1 month **Description:** The Motor Assessment Scale (MAS) is a clinical assessment tool that evaluates eight areas of motor function in recovering stroke patients **Measure:** Rivermead Motor Assessment Scale **Time Frame:** 1 month **Description:** The FIST tests balance in seated position. The patient should perform items with their best posture and balance, and while moving in a seated position. The therapist will give them occasional light pushes to test for balance reactions. The therapist will make sure they won't lose their balance. **Measure:** function in sitting test **Time Frame:** 1 month **Description:** The Berg Balance Scale is a testing tool with high validity and reliability used to measure balance. **Measure:** berg balance scale **Time Frame:** 1 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 1. Stable medical condition 2. Over 18 years of age 3. A score of 23 or above on the mini mental state test (MMDT) or the mini mental state test for the untrained (MMDT-E) 4. Within the period of 1-18 months after stroke 5. A score of 3 or 4 on the 3rd item of the Berg Balance Scale (BBS), which evaluates the balance of sitting without support (3= can sit for 2 minutes under supervision, 4= can sit safely for 2 minutes). Exclusion Criteria: * 1. Previous history of stroke 2. Aphasic patients in whom information exchange is not possible 3. Patients with impaired vision, hearing and vestibular system 4. Musculoskeletal and nervous system disorders other than stroke that may cause physical disability 5. Patients with a history of epilepsy 6. Cerebrovascular attack involving more than one hemisphere 7. Presence of cerebellar lesions or impaired cerebellar tests **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** ERVA KAHRAMAN, MD - **Phone:** +905392339083 - **Role:** CONTACT ***Contact 2:*** - **Name:** EBRU YILMAZ YALCINKAYA, PROF - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Turkey **Facility:** Erva Kahraman **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Sheehy L, Taillon-Hobson A, Sveistrup H, Bilodeau M, Fergusson D, Levac D, Finestone H. Does the addition of virtual reality training to a standard program of inpatient rehabilitation improve sitting balance ability and function after stroke? Protocol for a single-blind randomized controlled trial. BMC Neurol. 2016 Mar 31;16:42. doi: 10.1186/s12883-016-0563-x. **PMID:** 27036515 **Citation:** Karasu AU, Batur EB, Karatas GK. Effectiveness of Wii-based rehabilitation in stroke: A randomized controlled study. J Rehabil Med. 2018 May 8;50(5):406-412. doi: 10.2340/16501977-2331. **PMID:** 29620137 **Citation:** Marques-Sule E, Arnal-Gomez A, Buitrago-Jimenez G, Suso-Marti L, Cuenca-Martinez F, Espi-Lopez GV. Effectiveness of Nintendo Wii and Physical Therapy in Functionality, Balance, and Daily Activities in Chronic Stroke Patients. J Am Med Dir Assoc. 2021 May;22(5):1073-1080. doi: 10.1016/j.jamda.2021.01.076. Epub 2021 Feb 24. **PMID:** 33639116 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010243 - Term: Paralysis - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M9515 - Name: Hemiplegia - Relevance: HIGH - As Found: Hemiplegia - ID: M13157 - Name: Paralysis - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006429 - Term: Hemiplegia ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422741 **Acronym:** CIRCAFENOL **Brief Title:** Effect of a Grape Seed Proanthocyanidin Extract (GSPE) on LDL Cholesterol Levels in Rotating Night Shift Workers **Official Title:** Effect of a Grape Seed Proanthocyanidin Extract (GSPE) on LDL Cholesterol Levels in Rotating Night Shift Workers With Moderate Hypercholesterolemia. Randomized, Crossover, Controlled and Triple Blind Study.(CIRCAFENOL) #### Organization Study ID Info **ID:** CIRCAFENOL #### Organization **Class:** OTHER **Full Name:** Fundació Eurecat ### Status Module #### Completion Date **Date:** 2025-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University Rovira i Virgili #### Lead Sponsor **Class:** OTHER **Name:** Fundació Eurecat #### 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 physiological processes of the body present daily oscillations called circadian rhythm. The circadian rhythm is essential for maintaining the vital functions of organisms, intervening directly and indirectly in a multitude of key processes, such as hormone secretion, cycles of activity and rest throughout the day, body temperature, the metabolism or absorption, processing and detoxification of nutrients. There are factors such as certain work schedules, prolonged exposure to screens, certain eating patterns or social jetlag, which have a negative impact on the circadian rhythm, causing its disruption and favoring the appearance of health alterations. Thus, there is evidence that associates night shift work with a higher incidence of risk factors for developing metabolic syndrome and cardiovascular diseases, including obesity, elevated blood levels of glucose, triglycerides, and low-density lipoprotein cholesterol (LDL-C), as well as lower levels of high-density lipoprotein cholesterol (HDL-C). In addition, disorders in the sleep cycle are associated with the development of hypertension and type 2 diabetes. Several previous studies show that a grape seed proanthocyanidin extract (GSPE) has beneficial effects on different parameters by restoring the circadian rhythm. **Detailed Description:** The main objective of the study is to evaluate the effect of daily GSPE intake, in combined with dietary recommendations, on LDL-C levels in individuals with rotating night shift work. The secondary objectives are to evaluate the effects of GSPE on: anthropometric parameters,blood pressure, heart rate and endothelial function, markers of lipid and carbohydrate metabolism and insulin resistance, atherogenic indices, circulating levels of sex hormones and those related to hunger, satiety and stress; markers of systemic inflammation; circadian rhythm markers and sleep quality; level of physical activity, energy consumption, and changes in gene expression of key metabolic enzymes. A randomized, crossover, placebo-controlled, triple-blind nutritional intervention study will be conducted. The study will be carried out in a population of 22 volunteers. Men and women aged 18 years or older, who are working a rotating night shift for at least 1 year and with blood levels of LDL-C between 116 and 190 mg/dL may participate. Each volunteer will make 5 visits to the facilities of the EURECAT Nutrition and Health Technological Unit, in accordance with the study design: * A pre-selection visit (to check inclusion/exclusion criteria), and if the inclusion criteria are met. * Two study visits during consumption of the first product (GSPE or placebo), which will take place on the first day of study (visit 1) and after 6 weeks of treatment (visit 2). * Two study visits during consumption of the second product (GSPE or placebo), which will take place after a three-week washout period (visit 3), and after 6 weeks of treatment (visit 4). The main variable of the CIRCAFENOL study is circulating LDL-C levels. ### Conditions Module **Conditions:** - Cardiovascular Diseases - Circadian Rhythm Sleep Disorder, Shift Work Type - Cholesterol Level, High **Keywords:** - Proanthocyanidins - Circadian Rhythm - Metabolic Syndrome - Melatonin - Polyphenols ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 22 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive the grape seed proanthocyanidin extract (GSPE) for 6 weeks. **Intervention Names:** - Dietary Supplement: grape seed proanthocyanidin extract **Label:** grape seed proanthocyanidin extract **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive the placebo for 6 weeks. **Intervention Names:** - Dietary Supplement: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - grape seed proanthocyanidin extract **Description:** 250 mg of product presented in capsule form will be given. **Name:** grape seed proanthocyanidin extract **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** 165 mg of cellulose will be given presented in capsule form. **Name:** Placebo **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Serum LDL cholesterol levels will be measured by commercial colorimetric kit. **Measure:** Change in LDL cholesterol levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). #### Secondary Outcomes **Description:** Body weight will be measured by standardized method. **Measure:** Change in body weight. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Height will be measured by standardized method. **Measure:** Height. **Time Frame:** At week 1. **Description:** Weight and height will be combined to report BMI in kg/m\^2. **Measure:** Change in BMI. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Waist circumference will be measured using a measuring tape. **Measure:** Change in waist circumference. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Weight, height and waist circumference will be combined to report Conicity index. **Measure:** Change in conicity index. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Waist circumference and height will be combined to report Waist circumference to Height ratio. **Measure:** Change in waist circumference to height ratio. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Body fat will be measured by TANITA SC330. **Measure:** Change in the amount of body fat. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Muscle mass will be measured by TANITA SC330. **Measure:** Change in the amount of muscle mass. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Bone mass will be measured by TANITA SC330. **Measure:** Change in the amount of bone mass. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Total body water will be measured by TANITA SC330. **Measure:** Change in the amount of total body water. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Systolic blood pressure will be measured using an automatic sphygmomanometer. **Measure:** Change in systolic blood pressure. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Diastolic blood pressure will be measured using an automatic sphygmomanometer. **Measure:** Change in diastolic blood pressure. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Resting heart rate will be measured using an automatic sphygmomanometer. **Measure:** Change in resting heart rate. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Endothelial function will be measured using the Laser-Doppler technique. **Measure:** Change in endothelial function. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum total cholesterol levels will be measured by standardized ultraviolet-visible spectrophotometry methods. **Measure:** Change in serum total cholesterol levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum HDL-c levels will be measured by standardized ultraviolet-visible spectrophotometry methods. **Measure:** Change in serum HDL-c levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum triglycerides levels will be measured by standardized ultraviolet-visible spectrophotometry methods. **Measure:** Change in serum Triglycerides levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Total cholesterol and HDL-c values will be combined to report Total cholesterol to HDL-c ratio. **Measure:** Change in total cholesterol to HDL-c ratio. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** LDL-c and HDL-c values will be combined to report LDL-c to HDL-c ratio. **Measure:** Change in LDL-c to HDL-c ratio. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Plasma atherogenic index will be calculated as the logarithm of the triglycerides levels to HDL-c levels ratio. **Measure:** Change in Plasma atherogenic index. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum glucose levels will be measured by standardized ultraviolet-visible spectrophotometry methods. **Measure:** Change in serum glucose levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum insulin levels will be measured by spectrophotometry methods. **Measure:** Change in serum insulin levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum glycosylated hemoglobin levels will be measured by commercial kits. **Measure:** Change in serum glycosylated hemoglobin levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** HOMA-IR will be calculated using serum glucose and insulin levels. **Measure:** Change in Homeostatic Model Assessment from Insulin Resistance Index (HOMA-IR). **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum C-Reactive protein levels will be measured by plate test and by the agglutination of latex particles. **Measure:** Change in serum high sensitivity c-reactive protein levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum ghrelin levels will be measured by ELISA kits. **Measure:** Change in serum ghrelin levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum leptin levels will be measured by ELISA kits. **Measure:** Change in serum leptin levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum T3 levels will be measured by liquid chromatography coupled to mass spectrometry with triple quadrupole detector (LC-TQD-MS/MS). **Measure:** Change in circulating thyroid hormone T3 levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** SerumT4 levels will be measured by liquid chromatography coupled to mass spectrometry with triple quadrupole detector (LC-TQD-MS/MS). **Measure:** Change in circulating thyroid hormone T4 levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum testosterone levels will be measured by liquid chromatography coupled to mass spectrometry with triple quadrupole detector (LC-TQD-MS/MS). **Measure:** Change in circulating testosterone levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum estrone levels will be measured by liquid chromatography coupled to mass spectrometry with triple quadrupole detector (LC-TQD-MS/MS). **Measure:** Change in circulating estrone levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum 17-β-Estradiol levels will be measured by liquid chromatography coupled to mass spectrometry with triple quadrupole detector (LC-TQD-MS/MS). **Measure:** Change in circulating 17-β-Estradiol levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum estriol levels will be measured by liquid chromatography coupled to mass spectrometry with triple quadrupole detector (LC-TQD-MS/MS). **Measure:** Change in circulating estriol levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Serum melatonin levels will be measured by liquid chromatography coupled to mass spectrometry with triple quadrupole detector (LC-TQD-MS/MS). **Measure:** Change in serum melatonin levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** 6-Sulfatoxymelatonin levels will be measured in spontaneous urine samples from two times of the day: morning and night by ELISA kit. **Measure:** Change in urine 6-Sulfatoxymelatonin levels. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Activity and rest cycles will be measured subjectively by dream diaries. The sleep diary will be self-completed by the participant and will determine the time at which the person attempted to sleep, the duration and interruptions of nighttime sleep, the person's sleep pattern, and how much of the day the person was active. **Measure:** Change in activity and rest cycles (subjective measurement). **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Activity and rest cycles will be measured objectively by actigraphs. The wrist actigraphs will be worn 24 hours a day and will measure heart rate, which will give an idea of the amount of time the person was asleep and active. **Measure:** Change in activity and rest cycles (objective measurement). **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** It is a validated scale that measures the usual sleep habits during the past month. It consist of 7 areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. It contains a total of 19 items, grouped into 10 questions where each of the areas evaluated is a scored between 0 and 3. The scores from the seven areas are finally added up to give an overall score. The component score are summed to produce a global score (range 0 to 21). Higher score indicate worse sleep quality. **Measure:** Pittsburgh Sleep Quality Index. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** The chronotype will be evaluated using the Horne-Ostberg Morningness-Eveningness Questionnaire. Which consists of 19 questions that will allow volunteers to be classified into morning, night or intermediate people. **Measure:** Chronotype. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** GSPE metabolites will be measured by LC-TQD-MS/MS. **Measure:** Change in circulating GSPE metabolites. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Food consumption will be evaluated through a 3-day food record. **Measure:** Change in food consumption habits. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Physical activity will be evaluated through the Physical Activity Questionnaire, Quick Physical Activity Classifier, adapted from the PEFS guide of the Generalitat de Catalunya. The questionnaire asks about three specific types of activity (walking, moderate-intensity activities and vigorous intensity activities) in the set domains leisure time, domestic and gardening (yard) activities, work-related and transport-related activities. Frequency and duration are collected separately for each specific type of activity. **Measure:** Change in Physical activity. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Body temperature will be measured using a infrared thermometer according to a standardized measurement protocol. **Measure:** Change in body temperature. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** The expression of key genes in lipid and carbohydrate metabolism and regulation of the circadian rhythm will be measured through transcriptomic analysis, performing RNA extraction, conversion to cDNA and subsequent analysis. **Measure:** Change in gene expression in peripheral blood mononuclear cells. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** serum metabolites will be determined by LC-TQD-MS/MS. **Measure:** Change in serum metabolite profile. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Possible adverse events derived from taking study's products will be recorded. **Measure:** Adverse events **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Dietary supplements consumed during the study will be recorded in the case report form. **Measure:** Consumption of dietary supplements. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Concomitant medication will be recorded in the case report form. **Measure:** Concomitant medication. **Time Frame:** Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo). **Description:** Age will be recorded in years. It will be recorded in the case report form. **Measure:** Age. **Time Frame:** At week 1. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Men and women aged 18 years or older. * Follow a rotating night shift work schedule\* for at least one year before the start of the study. \* shift workers with at least 5 night shifts per month alternating with day and/or afternoon shifts, with a seniority equal to or greater than one year. * Have no intention of changing the work shift during the course of the study. * Circulating LDL-C levels between 116 -190 mg/dL\*, without pharmacological treatment with antihypertensives and/or lipid-lowering agents. \*Values of 116 to 190 mg/dl indicate moderate alteration in the lipid profile and a greater risk of suffering from cardiovascular diseases, according to the European Society of Cardiology, and the European Society of Atherosclerosis. * Have signed the informed consent before starting the study. * Know how to read, write and speak in Catalan or Spanish Exclusion Criteria: * BMI values \> 30 kg/m2 * Take supplements, multivitamin supplements (Vit.D, Vit. E and Vit.C), mineral supplements (Zinc, Selenium), essential fatty acids (omega-3), polyphenols, natural plant extracts, or phytotherapeutic products that interfere with the treatment under study. * Consumption of alcoholic beverages: * Men: consume 4 or more Standard Beverage Units daily or 28 Standard Beverage Units weekly. * Women: Consume 2 or more Standard Beverage Units daily or 17 Standard Beverage Units weekly. * Be an active smoker. * Having lost more than 3 kg of weight in the last 3 months. * Present food intolerances and/or allergies related to the study products, such as hypersensitivity to cellulose or proanthocyanidins. * Present any chronic or autoimmune disease in clinical manifestation that may affect the results of the study such as diabetes (type I or II), cardiovascular disease, chronic kidney disease, hyper or hypothyroidism, chronic gastrointestinal diseases or cancer. * Present familial hypercholesterolemia. * Present hypertension (Systolic ≥140 mmHg; Diastolic ≥90 mmHg) * Present any previous cardiovascular disease defined as myocardial infarction, angina pectoris, stroke or peripheral arterial disease. * Individuals with treatment in the last 3 months before the start of the study with lipid-lowering, antidiabetic and/or antihypertensive drugs, or other drugs that may interfere with the results of the study. * Taking supplements with polyphenol components or those aimed at lipid or blood pressure control in the last 3 months before the start of the study or during participation in the study. * Follow a diet to lose weight, or very restrictive types of eating, such as intermittent fasting, ketogenic diet, etc. * Being pregnant or intending to become pregnant. * Being breastfeeding. * Be participating or have participated in a clinical trial with medications or nutritional intervention study in the last 30 days before inclusion in the study. * Suffering from eating disorders or psychiatric disorders. * Being unable to follow study guidelines. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Antoni Caimari Palou, PhD **Phone:** 0034 977 300 805 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Anna Crescenti, PhD **Phone:** 0034 977 300 431 **Role:** CONTACT #### Locations **Location 1:** **City:** Reus **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Antoni Caimari Palou, PhD - **Phone:** 0034977300805 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Anna Crescenti, PhD - **Phone:** 0034977300431 - **Role:** CONTACT **Country:** Spain **Facility:** Eurecat **State:** Tarragona **Zip:** 43204 #### Overall Officials **Official 1:** **Affiliation:** UTNS (Eurecat, Reus) **Name:** Antoni Caimari Palou, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### See Also Links **Label:** Description Technological Centre of Nutrition and Health. Eurecat_Reus **URL:** http://eurecat.org ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009422 - Term: Nervous System Diseases - ID: D000009461 - Term: Neurologic Manifestations - ID: D000001523 - Term: Mental Disorders - ID: D000021081 - Term: Chronobiology Disorders - ID: D000020920 - Term: Dyssomnias - ID: D000009784 - Term: Occupational Diseases - ID: D000006949 - Term: Hyperlipidemias - ID: D000050171 - Term: Dyslipidemias - ID: D000052439 - Term: Lipid Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC24 - Name: Occupational Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M23005 - Name: Metabolic Syndrome - Relevance: LOW - As Found: Unknown - ID: M9988 - Name: Hypercholesterolemia - Relevance: HIGH - As Found: Cholesterol Level, High - ID: M22242 - Name: Parasomnias - Relevance: LOW - As Found: Unknown - ID: M22007 - Name: Sleep Disorders, Circadian Rhythm - Relevance: HIGH - As Found: Circadian Rhythm Sleep Disorder - ID: M15696 - Name: Sleep Wake Disorders - Relevance: HIGH - As Found: Sleep Disorders - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M22703 - Name: Chronobiology Disorders - Relevance: LOW - As Found: Unknown - ID: M22655 - Name: Dyssomnias - Relevance: LOW - As Found: Unknown - ID: M12719 - Name: Occupational Diseases - Relevance: LOW - As Found: Unknown - ID: M10002 - Name: Hyperlipoproteinemias - Relevance: LOW - As Found: Unknown - ID: M10000 - Name: Hyperlipidemias - Relevance: LOW - As Found: Unknown - ID: M26181 - Name: Dyslipidemias - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M27029 - Name: Lipid Metabolism Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012893 - Term: Sleep Wake Disorders - ID: D000020178 - Term: Sleep Disorders, Circadian Rhythm - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000006937 - Term: Hypercholesterolemia ### Intervention Browse Module - Ancestors - ID: D000000975 - Term: Antioxidants - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000020011 - Term: Protective Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000981 - Term: Antiprotozoal Agents - ID: D000000977 - Term: Antiparasitic Agents - ID: D000000890 - Term: Anti-Infective Agents ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: Ot - Name: Other Dietary Supplements - Abbrev: Fl - Name: Flavonoid - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: M11533 - Name: Melatonin - Relevance: LOW - As Found: Unknown - ID: M170641 - Name: Proanthocyanidin - Relevance: HIGH - As Found: S100B - ID: M266073 - Name: Procyanidin - Relevance: HIGH - As Found: S100B - ID: M4292 - Name: Antioxidants - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown - ID: M4298 - Name: Antiprotozoal Agents - Relevance: LOW - As Found: Unknown - ID: M4294 - Name: Antiparasitic Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: T410 - Name: Melatonin - Relevance: LOW - As Found: Unknown - ID: T39 - Name: Proanthocyanidin - Relevance: HIGH - As Found: S100B - ID: T40 - Name: Procyanidin - Relevance: HIGH - As Found: S100B - ID: T24 - Name: Anthocyanidin - Relevance: HIGH - As Found: S100B - ID: T173 - Name: Grape - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000013221 - Term: Proanthocyanidin - ID: C000017674 - Term: Procyanidin ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422728 **Brief Title:** The Effectiveness of Transdiagnostic CBT Protocol on Anxiety Disorders **Official Title:** The Effectiveness of Transdiagnostic CBT Protocol on Anxiety Disorders #### Organization Study ID Info **ID:** E-71395021-050.06.04-35012 #### Organization **Class:** OTHER **Full Name:** Ibn Haldun University ### Status Module #### Completion Date **Date:** 2025-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ibn Haldun University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The transdiagnostic approach argues that the common features are needed to be taken into account \[e.g. distress intolerance (DI), intolerance of uncertainty (IU), worry)\] underlying emotional disorders rather than evaluating them separately due to the fact that the dissection of anxiety disorders has increased with each emerging version of the Diagnostic and Statistical Manual of Mental Disorders (DSM), in which the classification of anxiety disorders resulted in an increased number of intervention protocols for each disorder. This also caused an increase of comorbidity among anxiety disorders. Transdiagnostic approach offers a unified protocol (UP) for strengthening the common features, and thereby both preventing the emergence of emotional disorders or intervening the symptom severity of emotional disorders, which can be applied to different types of emotional disorders. The main aim of this study is to develop a UP which is planned to be applied as a group therapy. The UP will include interventions developing the levels of common transdiagnostic features (DI, IU and worry). The study's second aim is to investigate the effect of the developed UP on DI, IU and worry. The third one is to search the effect of the developed UP on symptom severity levels of anxiety disorders. Fourthly, this study will search if the levels of transdiagnostic common features (DI, IU and worry) will predict the levels of symptom severity of anxiety disorders'. **Detailed Description:** The transdiagnostic approach argues that common features are needed to be taken into account \[e.g. distress intolerance (DI), intolerance of uncertainty (IU), worry\] underlying emotional disorders rather than evaluating them separately since the dissection of anxiety disorders has increased with each emerging version of the Diagnostic and Statistical Manual of Mental Disorders (DSM), in which the classification of anxiety disorders resulted in an increased number of intervention protocols for each disorder. That is why an increase in comorbidity among anxiety disorders is observed. The transdiagnostic approach offers a unified protocol (UP) for strengthening the common features, thereby preventing the emergence and intervening in several emotional disorders. As part of dissertation, the main aim of this study is to develop UP in Turkish, and measure the effectiveness of the UP on anxiety disorders and the transdiagnostic features. The UP is planned in group therapy format and includes interventions strengthening the common transdiagnostic features (DI, IU, and worry). This protocol is based on cognitive behavioral therapy (CBT) model. The sessions in the protocol are planned as follows: Session 1 is assessment session and Session 2 is on psychoeducation, which mainly intend to introduce the CBT model. In session 3, emotions are discussed, revealing that emotions point out what is important for us in life. In session 4, 5 and 6, thoughts are worked on. The participants learn to deal with worry and to challenge unfunctional thoughts and generate alternative explanations. Session 7 focuses on behaviors, in which the role of behaviors and the things that can/cannot be controlled are discussed. Session 8 includes a review of what has been learnt during the group therapy and an evaluation on maintaining the accomplishments. In addition, a follow-up session is planned after one month. In this study, there will be an intervention (UP) group and a control group. The participants will be assigned to the groups randomly. The measurements are the Distress Intolerance Scale (DTS), Intolerance of Uncertainty Scale-12 (IUS-12), Penn State Worry Questionnaire (PSWQ), Metacognitions Questionnaire-30 (MCQ-30), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder Assessment (GAD-7). The uniqueness of this protocol is to be the first UP in Turkish with its own order. It is expected to promote transdiagnostic studies in Turkey. This research is also important in contributing to the literature on transdiagnostic studies, which offer an alternative to comorbidity and a decrease in the symptom severity of anxiety disorders. ### Conditions Module **Conditions:** - Anxiety Disorders - Social Anxiety Disorder - Generalized Anxiety Disorder - Panic Disorder - Anxiety Disorder NOS **Keywords:** - transdiagnostic approach - unified protocol, - anxiety disorders - CBT - cognitive behavioral therapy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This study will search the effectiveness of the unified protocol on anxiety disorders. For this purpose, there will be an intervention group (unified protocol will be applied) and a control group. The participants will be assigned randomly to the groups. ##### Masking Info **Masking:** SINGLE **Masking Description:** In this study, single-blined procedure will be applied to reduce biases. For this purpose, participants will be informed only about the general procedure of group therapy (e.g. general focus of the group therapy, number of sessions, duration of sessions, number of participants) but will not be informed about which intervention they receive and which group they are assigned. **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The intervention group will receive the transdiagnostic unified protocol (UP) for anxiety disorders that is developed in this study. The UP is based on CBT model and will last for 8 weeks and there will be a follow-up session after one month. Each session will last 1 and a half hours. The pre-, post- and follow-up tests will be given to them to test the effectiveness of the UP. **Intervention Names:** - Other: Unified Protocol for Anxiety Disorders **Label:** Transdiagnostic Unified Protocol **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The supportive therapy group will also last for 8 weeks and there will be a follow-up session after one month. Each session will last 1 and a half hours. The pre-, post- and follow-up tests will be given to them, too. **Intervention Names:** - Other: Client-centered Supportive Therapy **Label:** Client-Centered Supportive Therapy **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Transdiagnostic Unified Protocol **Description:** The UP is planned in group therapy format and includes interventions on common transdiagnostic features. The sessions in the protocol are planned as follows: Session 1 - Assessment: introduction, talking on group rules and the process, setting goals Session 2 - Psychoeducation: the CBT model is introduced. Session 3 - Emotions: the role of emotions are discussed. Session 4, 5 \& 6 - Thoughts: the role of thoughts is mentioned. The participants learn to challenge unfunctional thoughts and generate alternative explanations. Also, exercises on excessive worry are applied. Session 7 - Behaviors: the role of behaviors and the things that can/cannot be controlled are discussed. Session 8 - Evaluation \& Maintaining Accomplishments: includes a review of what has been learnt during the group therapy and an evaluation on maintaining the accomplishments. Session 9 - Follow-up session: one month later. **Name:** Unified Protocol for Anxiety Disorders **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Client-Centered Supportive Therapy **Description:** Client-entered therapy provides a non-directive supportive environment for the participants, that includes reflective listening and nonjudgemental and empathic communication. In this group, no CBT intervention will be applied. Through the supportive and non-directive environment, only the effect of relationship will be investigated as a common factor in psychotherapy. **Name:** Client-centered Supportive Therapy **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Generalized Anxiety Disorder-7 (GAD-7) scale will be used to measure anxiety level. GAD-7 is a self-report scale consisting of 7 items. It is a 4-point Likert type scale. Items are scored between 0 (Not at all) and 3 (Nearly every day). Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety. In the total score, the cut-off score for GAD diagnosis is 10. **Measure:** Anxiety **Time Frame:** pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test) **Description:** Distress Tolerance Scale (DTS) scale will be used to measure distress tolerance level. DTS consists of a total of 15 items. Each item is rated on a 5-point Likert scale range from 1 (Strongly disagree) to 5 (Strongly disagree). A low total score indicates low distress tolerance level. **Measure:** Distress Tolerance **Time Frame:** pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test) **Description:** Intolerance of Uncertainty Scale (IUS) - Short Version will be used to measure the level of intolerance of uncertainty. IUS-12 is a self-report scale consisting of 12 items in total. It is a 5-point Likert scale. Each item is scored between 1 (not at all characteristic of me) to 5 (entirely characteristic of me). A high total score indicates a high level of intolerance to uncertainty. **Measure:** Intolerance of Uncertainty **Time Frame:** pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test) **Description:** Penn State Worry Questionnaire will be used to measure the level of worry. PSWQ is a self-report scale with a 5-point Likert-type, consisting of a total of 16 items. Scale items are scored between 1 (Not at all typical) - 5 (Very typical of me). An increase in the PSWQ total score indicates a high level of worry. **Measure:** Worry **Time Frame:** pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test) **Description:** Metacognition Questionnaire-30 Short Form will be used to measure metacognitive beliefs. MCQ-30, consisting of a total of 30 items, has a 4-point Likert-type scale. Each item is scored between 1 (Do not agree) and 4 (Agree very much). An increase in scale scores indicates an increase in pathological metacognitive activity. **Measure:** Metacognition **Time Frame:** pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test) **Description:** Patient Health Questionnaire-9 (PHQ-9) will be used to measure the level of depression. PHQ-9 consists of 9 questions which is a 4-point Likert type scale. Each item is scored between 0 (Not at all) - 3 (Nearly every day). As the total score increases, the severity of depression increases. **Measure:** Depression **Time Frame:** pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Being diagnosed with at least one of the following disorders in the pre-interview (SCID 5 interview for diagnosis): generalized anxiety disorder (GAD), panic disorder (PD), social anxiety disorder (SAD) or anxiety disorder not otherwise specified (NOS). Exclusion Criteria: * Active substance use or having a psychiatric history related to substance use * Having a co-diagnosis of psychotic disorders or bipolar disorders * Receiving active psychotherapy support * Being not graduated from primary school **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Iclal AYDIN, MA **Phone:** 00905353746285 **Role:** CONTACT #### Locations **Location 1:** **City:** Zeyti̇nburnu **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Iclal AYDIN, MA - **Phone:** 00905353746285 - **Role:** CONTACT **Country:** Turkey **Facility:** Iclal AYDIN **State:** İstanbul **Zip:** 34025 #### Overall Officials **Official 1:** **Affiliation:** İbn Haldun University **Name:** Iclal AYDIN, MA **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** There is no plan to share because of the ethical concerns of the participants' privacy. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001523 - Term: Mental Disorders - ID: D000010698 - Term: Phobic Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: HIGH - As Found: Anxiety Disorder - ID: M18970 - Name: Panic Disorder - Relevance: HIGH - As Found: Panic Disorder - ID: M1117 - Name: Phobia, Social - Relevance: HIGH - As Found: Social Anxiety Disorder - ID: M13603 - Name: Phobic 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: D000001008 - Term: Anxiety Disorders - ID: D000016584 - Term: Panic Disorder - ID: D000072861 - Term: Phobia, Social ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422715 **Acronym:** FIL_PTLD **Brief Title:** PTLD: Multicentric Retrospective Study **Official Title:** Post-transplant Lymphoproliferative Disorders (PTLD): Multicentric Observational Retrospective Cohort Study #### Organization Study ID Info **ID:** FIL_PTLD #### Organization **Class:** OTHER **Full Name:** Fondazione Italiana Linfomi - ETS ### Status Module #### Completion Date **Date:** 2026-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Pierre Fabre Pharma AG #### Lead Sponsor **Class:** OTHER **Name:** Fondazione Italiana Linfomi - ETS #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a multicentric observational retrospective cohort study of patients with histological diagnosis of PTLD. The aim of the study is to analyze the clinical features and survival of patients who received a PTLD diagnosis with the target to assess a survival outcome, to obtain an epidemiologic and clinical characterization of the subpopulations affected by PTLD, to recognize unfavorable properties, to report the current treatment strategies, to provide rationale for the design of a prospective registry in order to develop future novel treatments. **Detailed Description:** This is a multicentric observational retrospective cohort study of patients with histological diagnosis of PTLD. Retrospective data will be collected for all cases of PTLD diagnosed during a 10 years period since 1st January 2011 to 31th December 2021. The following clinical characteristics of the patient at the time of PTLD diagnosis and pathology will be taken into consideration: positivity of EBV virus, serum LDH concentration, PTLD subtype (early lesion, polymorphic or monomorphic PTLD), lymphoma histotype, stage of disease according to the Ann Arbor classification and localization (nodal or extranodal), immunosuppressive regimen taken by the patient since the transplant, therapeutic approach adopted, and response obtained. ### Conditions Module **Conditions:** - PTLD **Keywords:** - PTLD - lymphoproliferative disorders - transplant ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** patients with histological diagnosis obtained from a biopsy sample in 10 years' time frame (from 01/01/2011 to 31/12/2021) of PTLD (from allogeneic transplantation (both SOT and HSCT)) **Label:** patients with histological diagnosis of PTLD ### Outcomes Module #### Primary Outcomes **Description:** survival after PTLD incidence rating **Measure:** Rate of Overall Survival **Time Frame:** from diagnosis of PTLD to patient's death / last FUP - up to 18 months. **Description:** analyze the clinical and epidemiological features (e.g. positivity of EBV virus, serum LDH concentration, PTLD subtype (early lesion, polymorphic or monomorphic PTLD), lymphoma histotype, stage of disease according to the Ann Arbor classification and localization (nodal or extranodal), immunosuppressive regimen taken by the patient since the transplant, therapeutic approach adopted and response obtained) of PTLD patients **Measure:** clinical and epidemiological features **Time Frame:** from diagnosis of PTLD to patient's death/ last FUP - up to 18 months. #### Secondary Outcomes **Description:** compare outcomes according to treatment approaches **Measure:** Rate of Progression Free Survival **Time Frame:** from diagnosis of PTLD to patient's death/ last FUP - up to 18 months. **Description:** investigate potential treatment effect modifications on outcomes according to patient characteristics **Measure:** Overall Response Rate **Time Frame:** from treatment of PTLD to patient's death / last FUP - up to 18 months. **Description:** investigate potential treatment effect modifications on outcomes according to patient **Measure:** Complete Response Rate to first and subsequent treatments **Time Frame:** from treatment of PTLD to patient's death / last FUP - up to 18 months. **Description:** Overall Survival assessment stratified by prognostic factors (EBV, LDH, IPI, age, type of transplant) **Measure:** Overall Survival stratified by prognostic factors **Time Frame:** from diagnosis of PTLD to patient's death/ last FUP - up to 18 months. **Description:** Progression Free Survival assessment stratified by prognostic factors (EBV, LDH, IPI, age, type of transplant) **Measure:** Progression Free Survival stratified by prognostic factors **Time Frame:** from diagnosis of PTLD to patient's death/ last FUP - up to 18 months. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * histological diagnosis of PTLD obtained from a biopsy sample (availability of stocked biopsy sample is requested but not mandatory); * age over 18 years at time of diagnosis of PTLD; * previously subjected to allogeneic transplantation (both SOT and HSCT); * diagnosis of PTLD obtained in 10 years' time frame (from 01/01/2011 to 31/12/2021); * free and voluntary written informed consent (included unreachable subjects according to Art. 36 UE Regulation 2016/679 and to the current Italian Privacy Regulation). Exclusion Criteria: * Patients not meeting the above-mentioned inclusion criteria. **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Population will be composed by patients with histological diagnosis of PTLD. The following clinical characteristics of the patient at the diagnosis of PTLD and pathology will be taken into consideration: positivity of EBV virus, serum LDH concentration, PTLD subtype (early lesion, polymorphic or monomorphic PTLD), lymphoma histotype, stage of disease according to the Ann Arbor classification and localization (nodal or extranodal), immunosuppressive regimen taken by the patient since the transplant, therapeutic approach adopted and response obtained. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Uffici Studi FIL **Phone:** 0131033153 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Uffici Studi FIL **Phone:** 059 976 9910 **Role:** CONTACT #### Locations **Location 1:** **City:** Milano **Country:** Italy **Facility:** Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Ematologia **State:** MI **Zip:** 20122 **Location 2:** **City:** Ancona **Country:** Italy **Facility:** A.O. UNIVERSITARIA OSPEDALI RIUNITI - OSPEDALE UMBERTO I DI ANCONA - Clinica di Ematologia **Zip:** 60126 **Location 3:** **City:** Aviano **Country:** Italy **Facility:** Centro Di Riferimento Oncologico Di Aviano, S.O.C. Oncologia Medica e dei Tumori Immunocorrelati **Location 4:** **City:** Bergamo **Country:** Italy **Facility:** Azienda Ospedaliera Papa Giovanni XXIII - Ematologia **Zip:** 24127 **Location 5:** **City:** Bologna **Country:** Italy **Facility:** A.O. UNIVERSITARIA POLICLINICO S.ORSOLA-MALPIGHI DI BOLOGNA - Istituto di Ematologia "Seragnoli" **Zip:** 40138 **Location 6:** **City:** Brescia **Country:** Italy **Facility:** A.O. Spedali Civili di Brescia - Ematologia **Location 7:** **City:** Cagliari **Country:** Italy **Facility:** Ospedale Businco - Divisione di Ematologia **Location 8:** **City:** Cuneo **Country:** Italy **Facility:** A.O. S. Croce e Carle - S.C. di Ematologia e Trapianto di Midollo Osseo **Location 9:** **City:** Firenze **Country:** Italy **Facility:** A.O. UNIVERSITARIA CAREGGI DI FIRENZE - Unità funzionale di Ematologia **Zip:** 50139 **Location 10:** **City:** Miano **Country:** Italy **Facility:** ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia **Location 11:** **City:** Milano **Country:** Italy **Facility:** Istituto Scientifico San Raffaele - Unitа Linfomi - Dipartimento Oncoematologia **Zip:** 20132 **Location 12:** **City:** Novara **Country:** Italy **Facility:** AOU Maggiore della Caritа di Novara - SCDU Ematologia **Location 13:** **City:** Padova **Country:** Italy **Facility:** IRCCS ISTITUTO ONCOLOGICO VENETO (IOV) - Oncologia 1 **Zip:** 35128 **Location 14:** **City:** Pavia **Country:** Italy **Facility:** IRCCS Policlinico San Matteo - Divisione di Ematologia **Location 15:** **City:** Roma **Country:** Italy **Facility:** Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare **Zip:** 00128 **Location 16:** **City:** Roma **Country:** Italy **Facility:** Dipartimento di Medicina Traslazionale e di Precisione - Policlinico Umberto I - Università "La Sapienza" Istituto Ematologia **Zip:** 00161 **Location 17:** **City:** Roma **Country:** Italy **Facility:** Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica S. Cuore - Ematologia **Location 18:** **City:** Siena **Country:** Italy **Facility:** AOU Senese - U.O.C. Ematologia **Zip:** 53100 **Location 19:** **City:** Torino **Country:** Italy **Facility:** A.O. UNIVERSITARIA CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - SC Ematologia **Zip:** 10126 **Location 20:** **City:** Torino **Country:** Italy **Facility:** A.O. Città della Salute e della Scienza - Ematologia Universitaria **Location 21:** **City:** Udine **Country:** Italy **Facility:** Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica **Zip:** 33100 **Location 22:** **City:** Vicenza **Country:** Italy **Facility:** ULSS 8 Berica - Ospedale S. Bortolo - Ematologia **Zip:** 36100 #### Overall Officials **Official 1:** **Affiliation:** Ematologia Universitaria - A.O.U. Citta della Salute e della Scienza di Torino **Name:** Federica Cavallo, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008206 - Term: Lymphatic Diseases - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: HIGH - As Found: Lymphoproliferative Disorders - 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: T4650 - Name: Post-transplant Lymphoproliferative Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008232 - Term: Lymphoproliferative Disorders ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422702 **Brief Title:** The Effect of a Psychosomatic Symptom Intervention Program on the Primary Treatment of Differentiated Thyroid Cancer **Official Title:** A Prospective, Randomized, Single-blind Study on the Effects of Psychosomatic Symptom Interventions on Patients With Differentiated Thyroid Cancer During the Initial Treatment Period #### Organization Study ID Info **ID:** HMUDQ20231116204 #### Organization **Class:** OTHER **Full Name:** Harbin Medical University #### Secondary ID Infos **Domain:** National Natural Science Foundation of China **ID:** 72004047 **Type:** OTHER_GRANT **Domain:** Fundamental Research Funds for the Provincial Universities，Heilongjiang,China **ID:** JFCX202303 **Type:** OTHER_GRANT **Domain:** Postgraduate Research & Practice Innovation Program of Harbin Medical University **ID:** YJSCX2023-295HYD **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2024-08-22 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-01-22 **Type:** ACTUAL #### Start Date **Date:** 2023-08-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-12 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Harbin Medical University #### Responsible Party **Investigator Affiliation:** Harbin Medical University **Investigator Full Name:** Shuhua Luo **Investigator Title:** researcher **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Dear Sir/Madam, You are cordially invited to participate in a clinical study. Before deciding whether to participate, it is important that you understand this study. Please read the following information carefully. If you have fully understood the study, have no further questions, and decide to participate, you will need to sign an informed consent form. 1. Study Background Thyroid cancer is the most common malignant tumor of the endocrine system, with differentiated thyroid cancer (DTC) accounting for over 95% of cases. The initial treatment phase typically refers to the first year after patients undergo surgery, TSH suppression therapy, or radioactive iodine treatment. Studies have found that DTC patients may experience a variety of health-related issues during this stage. For instance, many patients not only suffer from neck discomfort and pain post-surgery but may also face risks of postoperative bleeding, nerve damage, reduced bone density, and other physical complications. They are more susceptible to anxiety, depression, sleep disturbances, and fear of recurrence. These psychological and physical symptoms can affect patients' ability to achieve target TSH levels, which is crucial for their prognosis. Therefore, this study aims to design an intervention plan for the psychosomatic symptoms of DTC patients in the initial treatment phase to improve their physiological discomfort and negative psychological experiences, enhance their self-management efficacy, and promote TSH suppression therapy compliance and overall health. 2. Study Objectives * To explore the impact of the psychosomatic symptom intervention plan on TSH levels, anxiety, depression, and self-management efficacy in patients with differentiated thyroid cancer during the initial treatment phase. * To provide a basis for improving the physical and mental health of DTC patients in the initial treatment phase. 3. Study Design and Process This study targets patients with differentiated thyroid cancer in the initial treatment phase. Participants will be divided into an intervention group and a control group using a block randomization method. The effectiveness of the plan will be tested through a 3-month intervention in a randomized controlled trial. Data collection points are baseline, at the end of the intervention, and 3 months post-intervention. The primary outcome measure is TSH levels, with secondary outcomes including anxiety, depression, and self-management efficacy. This could provide a basis for formulating scientifically sound health service policies, rational allocation and utilization of health resources, reducing the burden of medical services, and establishing a fair and efficient healthcare system. 4. Potential Benefits and Risks We will provide necessary advice for your current concerns and offer information related to differentiated thyroid cancer. Should you experience any discomfort during the study, please provide feedback to the medical staff in the research team promptly. We will dynamically assess your physiological and psychological changes and address them promptly, so there is no need for concern. 5. Handling of Harm The study involves a psychosomatic intervention lasting 12 weeks, with two sessions per week, each approximately 30 minutes. If you have any concerns during the intervention, you may contact us at any time. Our researchers, after various assessments, believe that this study will not harm your physical health. Even if you have signed this informed consent, you still retain all your legal rights. 6. Principles of Privacy and Confidentiality Your personal health information will be stored at Harbin Medical University and may be accessed by researchers, regulatory authorities, and the ethics committee. Any public reports on the results of this study will not disclose your personal identity. We will make every effort to protect your personal privacy within the legally permitted scope. By signing this informed consent, you agree to the use of your personal and health information as described above. 7. Voluntary Principle Participation in this study is entirely voluntary. You may refuse to participate or opt out of the study at any time without any reason. This decision will not affect your future daily life. However, it is hoped that you will complete this study unless there are special reasons. If you decide to withdraw under any circumstances, please inform the researchers. 8. Participant's Responsibilities Once you agree to participate in this study, you should cooperate with the researchers to complete the intervention study and promptly feedback your health recovery status to the researchers during the intervention. 9. Consultation about the Study If you have any questions related to this study, please contact the project leader: Shuhua Luo, at 17382839336. ### Conditions Module **Conditions:** - Pathologically Confirmed Differentiated Thyroid Carcinoma - All Patients Are in the Initial Treatment Phase - Normal Cognitive and Communicative Abilities, Capable of Reading and Understanding Questionnaires in Chinese - Ability to Use a Smartphone - Voluntary Participation in the Study and Signed Informed Consent **Keywords:** - Differentiated thyroid cancer - Anxiety - Depression - Thyroid stimulating hormone - Randomized block design ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** OTHER #### Enrollment Info **Count:** 84 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Implementation of a psychosomatic symptom intervention with a duration of three months. **Intervention Names:** - Other: Psychosomatic Symptoms Intervention **Label:** intervention group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The control group implemented continuity of supportive care based on primary care **Intervention Names:** - Other: Extended supportive care **Label:** control group **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - intervention group **Description:** Psychosomatic symptoms included intervention of negative psychological symptoms and intervention of physical discomfort symptoms. **Name:** Psychosomatic Symptoms Intervention **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - control group **Description:** The control group implemented continuity of supportive care based on primary care **Name:** Extended supportive care **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** This study is based on the recommended by 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer. First, in patients with a structural incomplete response to therapy, the serum TSH should be maintained below 0.1 mU/L. Secondly, in patients with a biochemical incomplete response to therapy, the serum TSH should be maintained between 0.1 and 0.5 mU/L. In patients with an excellent (clinically and biochemically free of disease) or indeterminate response to therapy, the serum TSH may be kept within the low reference range (0.5-2 mU/L). Finally, in patients who have not undergone remnant ablation, the serum TSH can be allowed to rise to the low reference range (0.5-2 mU/L). **Measure:** TSH **Time Frame:** Before the start of the intervention (T0), at the end of the intervention (up to 12 weeks of intervention, i.e., three months postoperatively, T1), and six months after the end of the intervention (i.e., nine months postoperatively, T2). #### Secondary Outcomes **Description:** The Hospital Anxiety and Depression Scale (HADS) was used to assess the anxiety and depression levels of DTC patients. The scale was developed by Zigmond in 1983 and is primarily used to assess the anxiety and depression of the subjects over the past month. A total of 14 items were included, comprising an anxiety subscale and a depression subscale, each containing 7 items. According to the frequency of occurrence, the situation is divided into four levels, namely "1 to 4", scored from 0 to 3 points, and the two subscales range from 0 to 21 points. The lowest possible score is 0, while the highest is 42. Higher scores on the scale indicate more severe levels of anxiety and depression. **Measure:** anxiety and depression **Time Frame:** Before the beginning of the intervention (T0), at the end of the intervention (12 weeks of intervention, T1), and 3 and 6 months after the end of the intervention (T2 and T3). **Description:** The Chinese version of Strategies Used by People to Promote Health (C-SUPPH) was used to evaluate the self-management efficacy of DTC patients. The scale was developed in 1996, and the Chinese version was revised by Huijuan Qian et al. There were 28 items in total, including 3 dimensions of positive attitude (items 7, 15 to 28), self-decision-making (items 10 to 12) and self-decompression (items 1 to 6, 8, 14). Each item was scored using the Likert 5 scale, with a score of 1 indicating no confidence and a score of 5 indicating very confident. The total score ranged from 28 to 140, ranging from 0 to 55 (low level), from 55 to 112 (medium level), and from \>112 (high level), with higher scores indicating greater confidence in the individual to perform self-care. **Measure:** Self-management efficacy **Time Frame:** Before the beginning of the intervention (T0), at the end of the intervention (12 weeks of intervention, T1), and 3 and 6 months after the end of the intervention (T2 and T3). **Description:** The Constant-Murley Shoulder Function Scale (CMS) was used to assess the shoulder joint activity of the two groups. The scale includes two dimensions: subjective evaluation and objective evaluation. Subjective evaluation included pain levels and activities of daily living. Objective evaluation included assessing shoulder range of motion and muscle strength. The lowest score is 0, the highest score is 100, higher scores indicate better shoulder function. **Measure:** Shoulder function **Time Frame:** Before the beginning of the intervention (T0), at the end of the intervention (12 weeks of intervention, T1), and 3 and 6 months after the end of the intervention (T2 and T3). ### Eligibility Module **Eligibility Criteria:** Inclusion criteria: 1. Clinical diagnosis of differentiated thyroid cancer 2. Participants had to be in the initial treatment phase 3. Cognitive and communication skills are normal 4. Can use a smartphone 5. Voluntary participation in the study Exclusion criteria: 1. History of neck or shoulder trauma 2. Coexisting serious heart, brain, or lung diseases 3. History of a major psychological disorder or mental illness 4. Patients taking hypnotics or psychotropic medications 5. have recently participated in a similar intervention or are receiving other psychotherapy **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Harbin **Country:** China **Facility:** Harbin Medical University **State:** Heilongjiang **Zip:** 150000 ## Document Section ### Large Document Module #### Large Docs - Date: 2023-05-01 - Filename: Prot_SAP_ICF_000.pdf - Has ICF: True - Has Protocol: True - Has SAP: True - Label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Size: 191154 - Type Abbrev: Prot_SAP_ICF - Upload Date: 2024-05-15T22:50 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004700 - Term: Endocrine System Diseases - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000006258 - Term: Head and Neck Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC19 - Name: Gland and Hormone Related Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M16723 - Name: Thyroid Neoplasms - Relevance: HIGH - As Found: Thyroid Cancer - ID: M16718 - Name: Thyroid Diseases - Relevance: HIGH - As Found: Thyroid - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013964 - Term: Thyroid Neoplasms - ID: D000013959 - Term: Thyroid Diseases ### 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:** NCT06422689 **Acronym:** ANCHOR **Brief Title:** Combination Short-Acting BroNchodilator and Inhaled Corticosteroid Rescue Therapy on Health Outcomes in Routine Care **Official Title:** ANCHOR - Assessment of Combination Short-Acting BroNchodilator and Inhaled Corticosteroid Rescue Therapy on Health Outcomes in Routine Care #### Organization Study ID Info **ID:** D6930L00001 #### Organization **Class:** INDUSTRY **Full Name:** AstraZeneca ### Status Module #### Completion Date **Date:** 2026-04-29 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-04-29 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-10 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-04-10 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Premier HealthCare Solutions Inc. #### Lead Sponsor **Class:** INDUSTRY **Name:** AstraZeneca #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** ANCHOR is a prospective, multi-center, phase IV, interventional, single-arm, open-label study of 2,000 adult participants with symptomatic asthma requiring the use of rescue therapy aimed to compare the asthma exacerbation rates before and after switching from albuterol or levalbuterol to albuterol plus budesonide inhalation aerosol as rescue therapy. **Detailed Description:** This study will primarily compare rates of asthma exacerbation during 12-month pre-switch period and 12-month post switch period among participants with asthma needing a rescue therapy. Other outcomes of interest for comparison between the pre- and post-switch periods include asthma-related oral corticosteroids (OCS) use, asthma exacerbation-related hospitalizations, emergency department (ED) visits, urgent care visits, outpatient visits, telehealth visits, and asthma-related and asthma exacerbation-related healthcare costs. The use of asthma control and rescue medications will be collected to understand treatment patterns in the real-world US context. ### Conditions Module **Conditions:** - Asthma **Keywords:** - Effectiveness - Asthma - Exacerbation - Healthcare resource utilization - Cost - Albuterol/budesonide - Short-acting beta-agonist (SABA) - Inhaled corticosteroids (ICS) - Rescue - Switch - Oral corticosteroid - Patients reported asthma symptoms - PT027 ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 2000 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive a fixed-dose combination of albuterol (90mcg) and budesonide (80mcg) administered as 2 inhalations (180mcg/160mcg) via pressurized metered dose inhaler (pMDI) as needed for asthma symptoms, for up to 12 inhalations (6 doses) in a 24-hour period. **Intervention Names:** - Drug: Albuterol and budesonide inhalation aerosol **Label:** Albuterol and budesonide inhalation aerosol **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Albuterol and budesonide inhalation aerosol **Description:** Participants will receive a fixed-dose combination of albuterol (90mcg) and budesonide (80mcg) administered as 2 inhalations (180mcg/160mcg) via pressurized metered dose inhaler (pMDI) as needed for asthma symptoms, for up to 12 inhalations (6 doses) in a 24-hour period. **Name:** Albuterol and budesonide inhalation aerosol **Other Names:** - PT027 **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Percentage of patients who reported improvement in asthma symptoms and satisfaction with albuterol and budesonide treatment as rescue therapy **Measure:** Improvement in patient reported asthma symptoms and treatment satisfaction using the ANCHOR PRO Questionnaire **Time Frame:** at 3-, 6-, 9-, and 12-month post-switch **Description:** Number of fills of asthma-related controllers and rescue medications **Measure:** Asthma-related controller and rescue medication use **Time Frame:** During 12-month pre-switch and 12-month post switch periods separately #### Primary Outcomes **Description:** Annualized Severe Asthma exacerbation rate **Measure:** Asthma exacerbation **Time Frame:** During 12-month pre-switch and 12-month post-switch periods #### Secondary Outcomes **Description:** Percentage of patients with Asthma exacerbation-related HCRU **Measure:** Asthma exacerbation-related HCRU **Time Frame:** During 12-month pre-switch and 12-mont post switch periods **Description:** Asthma exacerbation-related cost in US Dollars **Measure:** Asthma exacerbation-related cost **Time Frame:** During 12-month pre-switch and 12-month post-switch periods **Description:** Asthma-related cost in US Dollars **Measure:** Asthma-related cost **Time Frame:** During 12-month pre-switch and 12-month post-switch periods **Description:** Mean number of Asthma- related Oral Corticosteroid (OCS) prescriptions **Measure:** Asthma- related Oral Corticosteroid (OCS) use **Time Frame:** During 12-month pre-switch and 12-month post-switch periods **Description:** Percentage of patients with Asthma exacerbation-related HCRU at the health system level **Measure:** Change in asthma exacerbation-related HCRU at health system level **Time Frame:** During 12-month pre-switch and 12-month post-switch periods ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Adults aged 18 years and above as of enrollment date. 2. At least 1 visit with primary or secondary diagnosis of asthma on or within 12 months prior to the enrollment date. 3. At least 1 prescription filled for Short-acting beta-agonist (SABA)-only inhaler (i.e., albuterol-only or levalbuterol only inhalers) within 12 months before enrollment date. 4. At least 1 asthma exacerbation within 12 months before enrollment date. 5. Had both medical and pharmacy insurance coverage (e.g., Medicare, Medicaid, and commercial insurance) for at least 12 months before enrollment date and without foreseeable plans to discontinue insurance coverage within 12 months after enrollment date. 6. Participants also need to meet each of the following inclusion criteria: 1. Willingness to use albuterol and budesonide as rescue as instructed by their physician, prescribing information, and United States instruction for use (USIFU). 2. Willingness to respond to quarterly safety inquiries. 3. Willingness to participate in quarterly electronic patient-reported outcome (PRO) surveys via email or text. 4. Physician decision that participant is eligible for treatment with albuterol and budesonide as rescue according to the approved United States prescribing information (USPI). Exclusion Criteria: 1. Conditions with major respiratory diagnoses including chronic obstructive pulmonary disease (COPD), cystic fibrosis, pulmonary fibrosis, bronchiectasis, respiratory tract cancer, bronchopulmonary dysplasia, sarcoidosis, lung cancer, interstitial lung disease, pulmonary hypertension, and tuberculosis in 12 months before the enrollment date. 2. Inpatient admission or emergency department or urgent care visit due to asthma in the 10 days before enrollment date, or self-reported use of systemic corticosteroid for the treatment of asthma in the 10 days before enrollment date. Participants who were screen-failed due to this criterion may be re-screened once the participant is more than 10 days post asthma-related inpatient admission, emergency department or urgent care visit, or systemic corticosteroid use. 3. Chronic use of oral corticosteroids (for any condition) within 3 months before enrollment date. Chronic use of oral corticosteroids is defined as: daily or every other day use for 14 days or longer. 4. History of albuterol and budesonide as rescue use within 12 months before enrollment date. 5. History of any malignancy (except non-melanoma neoplasms of skin) in 12 months before the enrollment date. 6. For females only - currently pregnant or breastfeeding on enrollment date. Participants are excluded from the study if any of the following criteria apply. **Maximum Age:** 130 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** AstraZeneca Clinical Study Information Center **Phone:** 1-877-240-9479 **Role:** CONTACT #### Locations **Location 1:** **City:** Flint **Country:** United States **Facility:** Research Site **State:** Michigan **Status:** RECRUITING **Zip:** 48532 **Location 2:** **City:** Minneapolis **Country:** United States **Facility:** Research Site **State:** Minnesota **Status:** NOT_YET_RECRUITING **Zip:** 55425 #### Overall Officials **Official 1:** **Affiliation:** University of Michigan, Michigan, USA **Name:** Njira Lugogo, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Jefferson Health, Pennsylvania, USA **Name:** Neil Skolnik, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. **Description:** Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved. **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES **Time Frame:** AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. **URL:** https://vivli.org/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001982 - Term: Bronchial Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000008171 - Term: Lung Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M27137 - Name: Respiratory Aspiration - Relevance: LOW - As Found: Unknown - ID: M4556 - Name: Asthma - Relevance: HIGH - As Found: Asthma - ID: M5258 - Name: Bronchial Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001249 - Term: Asthma ### Intervention Browse Module - Ancestors - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000001993 - Term: Bronchodilator Agents - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018927 - Term: Anti-Asthmatic Agents - ID: D000019141 - Term: Respiratory System Agents - ID: D000005938 - Term: Glucocorticoids - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000015149 - Term: Tocolytic Agents - ID: D000012102 - Term: Reproductive Control Agents - ID: D000058666 - Term: Adrenergic beta-2 Receptor Agonists - ID: D000000318 - Term: Adrenergic beta-Agonists - ID: D000000322 - Term: Adrenergic Agonists - ID: D000018663 - Term: Adrenergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infl - Name: Anti-Inflammatory Agents ### Intervention Browse Module - Browse Leaves - ID: M3767 - Name: Albuterol - Relevance: HIGH - As Found: Unresectable - ID: M21711 - Name: Budesonide - Relevance: HIGH - As Found: Metabolic - ID: M5269 - Name: Bronchodilator Agents - Relevance: LOW - As Found: Unknown - ID: M4217 - Name: Anti-Inflammatory 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 - ID: M9047 - Name: Glucocorticoids - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M17869 - Name: Tocolytic Agents - Relevance: LOW - As Found: Unknown - ID: M20746 - Name: Adrenergic Agents - Relevance: LOW - As Found: Unknown - ID: M3670 - Name: Adrenergic beta-Agonists - Relevance: LOW - As Found: Unknown - ID: M3673 - Name: Adrenergic Agonists - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000019819 - Term: Budesonide - ID: D000000420 - Term: Albuterol ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422676 **Acronym:** MINERVA **Brief Title:** MultIceNtre Non-intERVentional Study for Efficacy,Safety Evaluation of BREZTRI in Pts With COPD in RussiA **Official Title:** Open-label Single-arm, Non-interventional, Multi-centre, Cohort Study for Evaluation of Clinical and Patient Reported Outcomes in New Users of BREZTRI (Budesonide / Glycopyrronium / Formoterol) in Routine Care Settings #### Organization Study ID Info **ID:** D5980R00097 #### Organization **Class:** INDUSTRY **Full Name:** AstraZeneca ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-12-29 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-02-29 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** AstraZeneca #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is a retrospective-prospective, non-interventional, multi-centre study that will be conducted in routine clinical settings in Russia. Eligible patients with moderate to severe COPD routinely treated with BREZTRI will be observed according to routine clinical practice for up to 24 weeks. **Detailed Description:** Chronic obstructive pulmonary disease (COPD) is a disease characterized by persistent airflow limitation that is usually progresses and is a consequence of a chronic inflammatory response of the respiratory pathways and lung tissue to the effects of inhaled harmful particles or gases. Exacerbations and comorbid conditions are an integral part of the disease and contribute significantly to the clinical picture and prognosis \[1\]. Patient-reported outcomes (both symptom-based and health-related quality of life-specific) are essential to evaluate symptoms, impact of symptoms on activities of daily living, and treatment response in COPD patients \[12\]. There is a need to evaluate the patient-reported outcomes during a triple therapy with budesonide + glycopyrronium bromide + formoterol (Breztri) in a real-life clinical practice. The aim of the study is to evaluate clinical and patient-reported outcomes of treatment with BREZTRI through effectiveness measures assessed pre- and post-treatment initiation and safety monitoring. The study results will be interpreted in the context of an open label, single arm study design where multiple factors, in addition to the new treatment, may contribute to the treatment effect. ### Conditions Module **Conditions:** - Chronic Obstructive Pulmonary Disease **Keywords:** - Chronic obstructive pulmonary disease - COPD - BREZTRI ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Change from baseline to 24 weeks in the CAT score. Minimum value - "0", maximum value - "5". Higher scores mean worse outcome. **Measure:** Change in COPD Assessment Test (CAT) score **Time Frame:** 24 weeks #### Secondary Outcomes **Description:** Change from baseline to 12 weeks in the CAT score. Minimum value - "0", maximum value - "5". Higher scores mean worse outcome. **Measure:** Change in COPD Assessment Test (CAT) score **Time Frame:** 12 weeks **Description:** Change from baseline to 24 weeks in FEV1 **Measure:** Change in FEV1 **Time Frame:** 24 weeks **Description:** Change from baseline to 24 weeks in the TSQM score. Minimum score - "1", maximum score - "7". Higher scores mean better outcome. **Measure:** Change in the Treatment Satisfaction Questionnaire for Medication (TSQM) score **Time Frame:** 24 weeks **Description:** • Percent of responders using the CAT who achieved MCID (minimal clinically important difference) = 2 or more points after 24 weeks of treatment **Measure:** MCID >= 2 **Time Frame:** 24 weeks of treatment **Description:** Percent of patients who are high adherent to therapy (who received 20 or more points at MARS) during 24 weeks; **Measure:** >= 20 points at MARS **Time Frame:** 24 weeks **Description:** Percent of patients with response (any category better than "no change") at the PGI-C after 24 weeks of treatment **Measure:** PGI-C - any improvement **Time Frame:** 24 weeks of treatment **Description:** • Percent of patients with change from baseline (before Breztri treatment start) in the severity of general COPD symptoms at the PGI-S after 24 weeks of treatment **Measure:** PGI-S - change from baseline **Time Frame:** after 24 weeks of treatment **Description:** to monitor AE frequency **Measure:** To describe treatment safety by AE (adverse events) monitoring **Time Frame:** AEs will be collected from the day when the informed consent has been signed (Visit 0) until the time last visit (Visit 2- 24 (+2) weeks after index date) has occurred **Description:** to collect information on treatment discontinuation due to AE **Measure:** Treatment safety by AE monitoring **Time Frame:** AEs will be collected from the day when the informed consent has been signed (Visit 0) until the time last visit (Visit 2- 24 (+2) weeks after index date) has occurred ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Physician-diagnosed COPD no less than 12 months before BREZTRI treatment start; 2. Patients who have not achieved adequate disease control when treated with a combination of ICS and LABA or a combination of LABA and LAMA 3. Initiated treatment with BREZTRI ≤12 weeks before inclusion as prescribed according to the label; 4. CAT score not more than 1 week before BREZTRI start is available; 5. Patients must be able and willing to read, comprehend and follow written instructions, and to comprehend and complete the questionnaires required by the protocol 6. Have signed a written Informed Consent Form (ICF). Exclusion Criteria: 1. Documented COPD due to α-1 antitrypsin deficiency; 2. Previous treatment with triple fixed-dose combination in 12 months prior to inclusion; 3. Pregnancy or lactation period; 4. Concomitant uncontrolled disease; 5. A diagnosis of bronchiectasis, sarcoidosis, interstitial lung disease, or idiopathic pulmonary fibrosis; 6. Participation in other non-interventional observational trials that might, in the investigator's opinion, influence the assessment for the current study, or participation in any observational or clinical trial in the last 30 days prior to inclusion. **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Patients \>= 18 y.o. with moderate to severe COPD who are eligible for BREZTRI therapy ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** AstraZeneca Clinical Study Information Center **Phone:** 1-877-240-9479 **Role:** CONTACT #### Locations **Location 1:** **City:** Saint-Petersburg **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Role:** CONTACT ***Contact 2:*** - **Name:** Veronika Popova - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Russian Federation **Facility:** Reavita Medical Centre **Status:** RECRUITING ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11168 - Name: Lung Diseases - Relevance: HIGH - As Found: Pulmonary Disease - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: HIGH - As Found: Obstructive Pulmonary Disease - ID: M23449 - Name: Pulmonary Disease, Chronic Obstructive - Relevance: HIGH - As Found: Chronic Obstructive Pulmonary Disease - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008171 - Term: Lung Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000029424 - Term: Pulmonary Disease, Chronic Obstructive ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21711 - Name: Budesonide - Relevance: LOW - As Found: Unknown - ID: M304 - Name: Formoterol Fumarate - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422663 **Acronym:** PRESENT **Brief Title:** A Study To Evaluate The Treatment Pattern Of Moderate-to-Severe Asthma Patients In China **Official Title:** A Prospective, Observational, Multicentre Study To Evaluate The Treatment Pattern Of Moderate-to-Severe Asthma Patients In China #### Organization Study ID Info **ID:** D2287R00198 #### Organization **Class:** INDUSTRY **Full Name:** AstraZeneca ### Status Module #### Completion Date **Date:** 2025-02-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-02-28 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-22 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-03-19 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** AstraZeneca #### 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 Prospective, Observational, Multicentre Study to describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients in China. Sponsor by Astrazeneca Investment(China) Co., LTD. **Detailed Description:** This is a prospective, observational, multicentre study. Approximately 500 moderate-to-severe asthma patients from 30 sites across China. Patients will be treated following routine clinical practice. Study measures will be collected at week 0, week 12 and week 24. The primary objective of PRESENT study is to describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients in China. ### Conditions Module **Conditions:** - Moderate-to-Severe Asthma ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** enroll 500 subjects **Label:** Moderate-to-Severe Asthma ### Outcomes Module #### Other Outcomes **Description:** To summarize the safety data, including frequency of adverse events **Measure:** Frequency of adverse events **Time Frame:** week 0, week 12 and week 24 **Description:** To summarize the safety data, including percentage of adverse events. **Measure:** Percentage of adverse events. **Time Frame:** week 0, week 12 and week 24 **Description:** To summarize the safety data, including frequency of serious adverse events. **Measure:** Frequency of serious adverse events. **Time Frame:** week 0, week 12 and week 24. **Description:** To summarize the safety data, including percentage of serious adverse events. **Measure:** Percentage of serious adverse events. **Time Frame:** week 0, week 12 and week 24 #### Primary Outcomes **Description:** To describe treatment modification of uncontrolled moderate-to-severe asthma patients in China. **Measure:** Proportion of uncontrolled patients with treatment modification, which is indicated by maintenance drug dosage change, switch, add-on, discontinue from week 0 to week 24 **Time Frame:** week 0, week 12 and week 24. #### Secondary Outcomes **Description:** To describe disease burden of moderate-to-severe-asthma patients and to describe by different subgroups. To describe disease burden and treatment patterns by stratification of baseline EOS and baseline eosinophilic phenotype at week 0,12\&24. To describe disease burden and treatment patterns by baseline asthma severity(moderate or severe) at each follow-up assessment. To describe disease burden and treatment patterns by regions (south, west, east, north, central) **Measure:** Ashma disease burden: Exacerbation rate **Time Frame:** week 0, week 12 and week 24 **Description:** To describe the proportion of severe asthma among all patients according to GINA 2023 \& CN 2020 guidelines **Measure:** Proportions of severe asthma (GINA 2023 & CN 2020 guideline) at baseline & each follow-up assessment **Time Frame:** week 0, week 12 and week 24 **Description:** To describe EOS levels and proportion of eosinophilic phenotype patients at week 0,12\&24 **Measure:** Levels of bEOS at each follow-up assessment. Proportions of eosinophilic phenotype **Time Frame:** week 0, week 12 and week 24 **Description:** To describe healthcare utilization by baseline asthma severity (moderate or severe) **Measure:** Asthma-related emergency visit. **Time Frame:** week 0, week 12 and week 24 **Description:** To describe disease burden of moderate-to-severe-asthma patients and to describe by different subgroups. To describe disease burden and treatment patterns by stratification of baseline EOS and baseline eosinophilic phenotype at week 0,12\&24. To describe disease burden and treatment patterns by baseline asthma severity(moderate or severe) at each follow-up assessment. To describe disease burden and treatment patterns by regions (south, west, east, north, central) **Measure:** Ashma disease burden: Asthma Control Test **Time Frame:** week 0, week 12 and week 24 **Description:** To describe disease burden of moderate-to-severe-asthma patients and to describe by different subgroups. To describe disease burden and treatment patterns by stratification of baseline EOS and baseline eosinophilic phenotype at week 0,12\&24. To describe disease burden and treatment patterns by baseline asthma severity(moderate or severe) at each follow-up assessment. To describe disease burden and treatment patterns by regions (south, west, east, north, central) **Measure:** Ashma disease burden: Lung function (FEV1) **Time Frame:** week 0, week 12 and week 24 **Description:** To describe disease burden and treatment patterns by stratification of baseline EOS and baseline eosinophilic phenotype at week 0,12\&24. To describe disease burden and treatment patterns by baseline asthma severity(moderate or severe) at each follow-up assessment. To describe disease burden and treatment patterns by regions (south, west, east, north, central) **Measure:** Asthma disease burden: Treatment patterns **Time Frame:** week 0, week 12 and week 24 **Description:** To describe healthcare utilization by baseline asthma severity (moderate or severe) **Measure:** Asthma-related outpatient visit. **Time Frame:** week 0, week 12 and week 24 **Description:** To describe healthcare utilization by baseline asthma severity (moderate or severe) **Measure:** Asthma-related hospitalization: Length of stay, Invasive and non-invasive ventilator use. **Time Frame:** week 0, week 12 and week 24 **Description:** To describe healthcare utilization by baseline asthma severity (moderate or severe) **Measure:** Asthma-related diagnostic tests (X-ray, CT scan, et al.) **Time Frame:** week 0, week 12 and week 24 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Physician-confirmed asthma diagnosis with documented evidence of variable expiratory airflow limitation (e.g., from bronchodilator reversibility testing or other tests) 2. Written informed consent 3. Moderate-to-severe asthma (asthma patients with treatment of GINA Step 3-5) 4. Age 12 years old and above Exclusion Criteria: 1. Previous diagnosis of chronic obstructive pulmonary disease (COPD) or other clinically relevant chronic respiratory disease other than asthma 2. Received an investigational therapy for asthma, allergy, atopic disease, or eosinophilic disease as part of a clinical trial during the 6 months prior to enrolment. (Once enrolled in the PRESENT Study, patients should not enrol in any investigational trials.) 3. Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate in the study 4. Disease or condition other than asthma that requires treatment with systemic or oral steroids 5. Patients with poor inhaler skills and adherence **Maximum Age:** 130 Years **Minimum Age:** 12 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Moderate-to-Severe Asthma Patients ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** AstraZeneca Clinical Study Information Center **Phone:** 1-877-240-9479 **Role:** CONTACT #### Locations **Location 1:** **City:** Shanghai **Country:** China **Facility:** Shanghai Tongji Hospital **State:** Shanghai **Status:** RECRUITING **Zip:** 20000 ### IPD Sharing Statement Module **Access Criteria:** When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. URL: https://vivli.org/ **Description:** Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved. **IPD Sharing:** YES **Time Frame:** AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. **URL:** https://vivli.org/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001982 - Term: Bronchial Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000008171 - Term: Lung Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4556 - Name: Asthma - Relevance: HIGH - As Found: Asthma - ID: M5258 - Name: Bronchial Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001249 - Term: Asthma ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422650 **Brief Title:** Effect of Nigella Sativa in Atorvastatin Treated Hyperlipidaemia **Official Title:** Effect of Nigella Sativa on Blood Lipids as an add-on Therapy in Atorvastatin Treated Hyperlipidaemic Patients. A Randomized Controlled Trial #### Organization Study ID Info **ID:** BSMMU/2023/11004 #### Organization **Class:** OTHER **Full Name:** Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh ### Status Module #### Completion Date **Date:** 2024-08-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-08-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-08-24 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh #### Responsible Party **Investigator Affiliation:** Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh **Investigator Full Name:** Farzana Siddiqua **Investigator Title:** Resident, MD, Pharmacology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study will be 8 weeks randomized, double-blind, placebo-controlled trail to assess the effect of Nigella Sativa in 84 Hyperlipidaemic patients. Participants will be assessed at baseline and after 8 weeks of intervention. Subjects will be randomized to receive either Nigella Sativa 500 mg capsule daily or placebo capsule identical to Nigella Sativa twice daily for 8 weeks. Evaluation of lipid profile, SGPT, S.Creatinine will be before and after 8 weeks of intervention. Nigella Sativa related adverse events will be identified. Study outcome will establish safety and efficacy of Nigella Sativa in atorvastatin treated hyperlipidaemic patients **Detailed Description:** Hyperlipidemia is one of the most important risk factors to cause atherosclerosis that ultimately triggers cardiovascular complications like myocardial infarction, ischemic stroke, peripheral vascular disease etc. These are considered as the leading cause of mortality and morbidity worldwide. Nigella sativa has both lipid lowering and anti-oxidant potentials. In this regard Nigella Sativa can be given with standard therapy to regulate blood lipids. Aim of this study: This proposed study is therefore an effort to find out the safety and efficacy of Nigella Sativa in patient with hyperlipidemia.This study will be a single center study, utilizing a randomized, double-blind, placebo controlled trial. It will be conducted in the department of pharmacology, BSMMU in collaboration with the department of cardiology, BSMMU from the day of approval by the Institutional Review Board to June, 2024. The study will involve a total of Eighty four (84) patients attended in the outpatient department of cardiology, BSMMU, diagnosed as hyperlipidemia, with 42 of them receiving standard treatment along with a twice daily dose of 500mg of Nigella Sativa capsule for 8 weeks. The remaining 42 patients will undergo standard treatment along with a placebo over the same duration. The data collected will be analyzed through descriptive statistical techniques, offering a comprehensive summary of the results. In this study we will assess various sociodemographic characteristics of all the participants, including like age, sex, body mass index (BMI).In addition to these factors we will also evaluate their lipid profile, serum glutamic pyruvic transaminase (SGPT), serum creatinine level at baseline and after 8 weeks of interventions. Addition of Nigella Sativa with the conventional treatment of Statin could potentially reduce blood lipids in patients with hyperlipidemia. ### Conditions Module **Conditions:** - Hyperlipidemia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 84 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will receive Nigella Sativa (500mg) capsule twice daily for 8 weeks. **Intervention Names:** - Drug: Nigella Sativa capsule 500mg **Label:** Nigella Sativa **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients will receive capsules of placebo twice daily for 8 weeks. **Intervention Names:** - Drug: Placebo **Label:** Control **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Nigella Sativa **Description:** Nigella Sativa capsule 500mg twice daily for 8 weeks **Name:** Nigella Sativa capsule 500mg **Other Names:** - Black seed oil **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Control **Description:** Oral placebo identical to astaxanthin **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** 84 atorvastatin treated hyperlipidaemic patients will randomly receive 8 weeks oral twice daily course of either Nigella Sativa 500 mg capsule or placebo.Change in blood lipids will be measured by spectrophotometer. **Measure:** Change in blood lipids **Time Frame:** 8 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Newly diagnosed hyperlipidaemic patient. 2. Both male and female 3. Hyperlipidemic patients suffering from ischemic heart disease, diabetes mellitus, hypertension 4. Diagnostic criteria for dyslipidemic patients 1. Total cholesterol 200mg/dl 2. LDL-C 140mg/dl 3. Triglyceride 150mg/dl 4. HDL \<40mg/dl Exclusion Criteria: 1. Patients with renal impairment 2. Patients with active liver disease 3. Patients having history of hypersensitivity on any member of statins 4. Pregnant woman. 5. lactating mother **Healthy Volunteers:** True **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Farzana Siddiqua, MBBS **Phone:** 01842378736 **Role:** CONTACT **Contact 2:** **Name:** Adhir K Das **Phone:** 01711961097 **Role:** CONTACT #### Locations **Location 1:** **City:** Dhaka **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Farzana Siddiqua, MBBS - **Phone:** 01842378736 - **Role:** CONTACT **Country:** Bangladesh **Facility:** BSMMU **Status:** RECRUITING **Zip:** 1000 #### Overall Officials **Official 1:** **Affiliation:** Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh **Name:** Farzana Siddiqua, MBBS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000050171 - Term: Dyslipidemias - ID: D000052439 - Term: Lipid Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10002 - Name: Hyperlipoproteinemias - Relevance: HIGH - As Found: Hyperlipidemia - ID: M10000 - Name: Hyperlipidemias - Relevance: HIGH - As Found: Hyperlipidemia - ID: M26181 - Name: Dyslipidemias - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M27029 - Name: Lipid Metabolism Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006949 - Term: Hyperlipidemias - ID: D000006951 - Term: Hyperlipoproteinemias ### Intervention Browse Module - Browse Branches - Abbrev: Lipd - Name: Lipid Regulating Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: M351 - Name: Atorvastatin - Relevance: LOW - As Found: Unknown - ID: T238 - Name: Nigella - Relevance: HIGH - As Found: Topical anesthesia ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422637 **Brief Title:** A Prospective Interventional Study on Early Screening for Lung Cancer Using Liquid Biopsy **Official Title:** INFORM: A Prospective Interventional Study on Early Screening for Lung Cancer Using Liquid Biopsy #### Organization Study ID Info **ID:** ES-2024-025-02 #### Organization **Class:** OTHER **Full Name:** The First Affiliated Hospital of Guangzhou Medical University ### Status Module #### Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-19 ### 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:** Jianxing He **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This project aims to establish the MERCURY pilot screening program as part of the "Love Lung Project," employing a novel concept of lung cancer screening with the assistance of low-dose computer tomography (LDCT). By using clinical pathology as the gold standard, it will parallelly compare the performance (with a sensitivity of ≥90%) of the MERCURY early lung cancer screening model against the LDCT-only screening group within the "Love Lung Project." Ultimately, the objective is to reduce the proportion of overtreatment, achieve earlier staging, and extend patient survival, thus enhancing clinical value. **Detailed Description:** This study is the first international prospective interventional study for lung cancer screening. It designates the "Love Lung Program" using Low-Dose Computed Tomography (LDCT) screening as the control group and the MERCURY screening group as the intervention group. Participants from the general population were enrolled and randomly assigned to either group in a 1:1 ratio. The MERCURY group plans to collect baseline peripheral blood samples from 2,972 individuals for whole genome sequencing (WGS) based on plasma circulating free DNA (cfDNA). This will facilitate a comprehensive analysis of the fragmentomics characteristics of cfDNA. Through the MERCURY early lung cancer screening model, individuals potentially at early stages of lung cancer will be identified. Those showing positive signs will subsequently undergo sequential LDCT to further confirm lung cancer status, eventually confirmed via surgery or pathology. To minimize ethical risks, the negative cases will receive additional LDCT after three months to further confirm their lung status. The control group under the "Love Lung Program" will follow standard LDCT screening procedures with the same number of participants; those with positive LDCT results will undergo clinical diagnosis, while those with negative results will only be followed up for lung status. Relying on the "Love Lung Program," the objective is to establish a new concept of lung cancer screening that precedes with MERCURY screening assisted by LDCT diagnostics. ### Conditions Module **Conditions:** - Liquid Biopsy for Early Screening of Lung Cancer **Keywords:** - Lung Cancer - Liquid Biopsy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** SCREENING #### Enrollment Info **Count:** 5944 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** By collecting 2,972 peripheral blood samples from a natural population baseline, a comprehensive analysis of the fragmentomic characteristics of cfDNA was conducted based on whole-genome sequencing (WGS) of plasma cfDNA. **Intervention Names:** - Diagnostic Test: Liquid Biopsy Early Screening **Label:** Intervention group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 2972 individuals were enrolled from the general population for routine LDCT screening. **Label:** control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention group **Description:** An early screening model for lung cancer aids in identifying individuals with early-stage lung cancer. Those with positive indications of lung cancer will subsequently undergo confirmatory clinical assessments using Low-Dose Computed Tomography (LDCT) in sequence. Ultimately, a definitive diagnosis of lung cancer is established through surgical and pathological examination. **Name:** Liquid Biopsy Early Screening **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** When a test result indicates that a patient is positive, the probability that the true condition is positive. **Measure:** Positive Predictive Value **Time Frame:** 2 years #### Secondary Outcomes **Description:** the proportion of patients diagnosed with lung cancer through clinical pathology in both the intervention group and the control group. **Measure:** Detection rate of non-stage 0 lung cancer within 2 years **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age greater than 40 years old and less than 75 years old, regardless of gender. * Sign the informed consent form. Exclusion Criteria: * Pregnant women; * Individuals currently diagnosed with any tumors other than lung cancer, or who have a history of cancer; * Those who have undergone LDCT/CT screening within the past 1-3 years; * Individuals currently suffering from a febrile illness, or who have had an acute inflammatory disease episode requiring internal medicine treatment within the last 14 days prior to blood draw; * Individuals who have taken corticosteroids orally or through intravenous injection within the 14 days prior to blood draw; * Organ transplant recipients or those who have previously received a non-autologous (allogeneic) bone marrow or stem cell transplant; * Individuals in poor health or not suitable for blood drawing; * Any other clinically significant disease or condition considered by the researchers to potentially affect adherence to the protocol, impact the patient's ability to provide informed consent, or render the patient unsuitable for participation in the clinical trial. **Healthy Volunteers:** True **Maximum Age:** 75 Years **Minimum Age:** 40 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jianxing He, MD **Phone:** 86-20-83337792 **Role:** CONTACT #### Locations **Location 1:** **City:** Guangzhou **Country:** China **Facility:** Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College **State:** Guangdong **Zip:** 510120 #### Overall Officials **Official 1:** **Affiliation:** Department of Medical Oncology of Respiratory, Guangxi Medical University Cancer Hospital **Name:** Jianxing He, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** publish an article **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M11172 - Name: Lung Neoplasms - Relevance: HIGH - As Found: Lung Cancer - ID: 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: D000008175 - Term: Lung Neoplasms ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422624 **Brief Title:** A Study to Evaluate Safety, Tolerability and pK of Semaglutide ER Injectable Suspension in Healthy, Adult Human Subjects **Official Title:** An Open Label, Single Dose, Dose Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Semaglutide Extended-release Injectable Suspension in Normal Healthy, Adult, Human Study Participants Under Fasting Condition #### Organization Study ID Info **ID:** 15403/23-24 #### Organization **Class:** INDUSTRY **Full Name:** Bostal Drug Delivery Co., Ltd ### Status Module #### Completion Date **Date:** 2024-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-08 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Bostal Drug Delivery Co., Ltd #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** The purpose of the trail is to evaluate the safety, tolerability and pharmacokinetics of a single escalated doses of semaglutide extended-release injectable suspension in healthy adult, human study participants under fasting condition. ### Conditions Module **Conditions:** - Diabetes Mellitus, Type 2 ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 14 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants receive a single of semaglutide ER injectable suspension at a lower dose 1 mg for safety, tolerability and pharmacokinetics assessements **Intervention Names:** - Drug: Semaglutide Extended-release for Injectable Suspension, 1 mg **Label:** Semaglutide ER Injectable Suspension, 1 mg **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants receive a single of semaglutide ER injectable suspension at a medium dose 4 mg for safety, tolerability and pharmacokinetics assessements **Intervention Names:** - Drug: Semaglutide Extended-release for Injectable Suspension, 4 mg **Label:** Semaglutide ER Injectable Suspension, 4 mg **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Participants receive a single of semaglutide ER injectable suspension at a higher dose 8 mg for safety, tolerability and pharmacokinetics assessements **Intervention Names:** - Drug: Semaglutide Extended-release for Injectable Suspension, 8 mg **Label:** Semaglutide ER Injectable Suspension, 8 mg **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Semaglutide ER Injectable Suspension, 1 mg **Description:** Singel-dose; Subcutaneous **Name:** Semaglutide Extended-release for Injectable Suspension, 1 mg **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Semaglutide ER Injectable Suspension, 4 mg **Description:** Singel-dose; Subcutaneous **Name:** Semaglutide Extended-release for Injectable Suspension, 4 mg **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Semaglutide ER Injectable Suspension, 8 mg **Description:** Singel-dose; Subcutaneous **Name:** Semaglutide Extended-release for Injectable Suspension, 8 mg **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Maximum plasma concentration **Measure:** Cmax **Time Frame:** From time zero up to the last time point with measurable concentration **Description:** Area under the plasma concentration time curve from time zero to the last measurable concentration **Measure:** AUC0-t **Time Frame:** From time zero up to the last time point with measurable concentration **Description:** Area under the plasma concentration-time curve from time zero to infinity **Measure:** AUC0-inf **Time Frame:** From time zero up to the last time point with measurable concentration ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. He/She should provide written informed consent. 2. He/She must be a healthy adult human male or non-pregnant, non-lactating females,18 - 45 years of age (both years inclusive). 3. He/She should have a body mass index ≥ 18.5 kg/m2 and ≤ 24.9 kg/m2 with body weight at least 55 kg for men and at least 48 kg for women. 4. He/She should have a baseline systolic blood pressure with upper limit of less than 140 mmHg and lower limit of more than or equal to 100 mm Hg. Similarly baseline diastolic blood pressure with upper limit less than 90 mm Hg and lower limit more than or equal to 60 mmHg. 5. He/She should have pulse rate not less than 60 beats/min and not more than 100 beats/min and respiratory rate not less than 14 breaths/min and not more than 18 breaths/min. 6. He/She must be of normal health as determined by medical history (including medication history) and physical examination performed within 21 days prior to the dosing. 7. He/She should have normal ECG, chest X-ray and vital signs. 8. He/She should have normal or clinically non-significant thyroid function tests (T3, T4 and TSH). 9. Availability of a study volunteer for the entire study duration and willingness to adhere to protocol requirements as evidenced by written informed consent. 10. If study volunteer is a female and is of child bearing potential practicing an acceptable method of birth control such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence for the duration of the study as judged by the investigator(s), or If she is postmenopausal with spontaneous amenorrhea for at least 01 year. or If she is surgically sterile (had a bilateral tubal ligation, bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 06 months). Exclusion Criteria: 1. He/She is incapable of understanding the informed consent. 2. He/She has a history of hypersensitivity (e.g. anaphylactic reactions, angioedema and serious skin reactions) or idiosyncratic reaction to active or inactive ingredient in the Semaglutide extended-release injectable suspension or any other related drugs. 3. He/She has a history of impairment of renal, hepatic, cardiac, pulmonary or gastrointestinal function. 4. He/She has a history of tuberculosis, epilepsy, asthma, diabetes, psychosis and eye disorders. 5. He/She has history of any pulmonary disorder (COPD, Asthma, Bronchitis, other respiratory disorders) and skin related disorders. 6. He/She has a personal or family history of Medullary Thyroid Carcinoma (MTC) or any other thyroid tumors or Multiple Endocrine Neoplasia 2 (MEN 2) or any other endocrine disorders. 7. He/She has a history of pancreatitis, diabetic retinopathy, gall bladder disease. 8. He/She has undergone surgery within the past 3 months prior to screening, or those planning to undergo surgery during the trial period. 9. He/She has any difficulty in swallowing. 10. He/She regularly smokes more than 10 cigarettes daily or has difficulty in abstaining from tobacco for the entire study duration. 11. He/She has taken over the counter or prescribed medications, including vitamins, herbal supplements, insulin or drugs which promote insulin secretion, Sulfonylureas, any oral medications or any systemic medication within the past 30 days prior to dosing. 12. He/She has a history of any psychiatric illness, which may impair the ability to provide written, informed consent. 13. He/She has a history of alcohol or substance abuse within the last 05 years. 14. He/she using prohibited medications (e.g., sedative hypnotics, CNS depressants, including but not limited to opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, sedating antiepileptic drugs, general anesthetics, muscle relaxants, and/or illicit CNS depressants). 15. He/She has clinically significant abnormal values of laboratory parameters. 16. He/She has participated in any other clinical investigation using experimental drug or had bled more than 350 mL in the past 90 days. 17. He/She is unable to or unlikely to be compliant with protocol requirements or restrictions. 18. He/She, in whom study drug is contraindicated for medical reasons. 19. He/She is intolerant to venipuncture. 20. Positive results at screening for HIV, hepatitis B surface antigen (HBsAg), hepatitis C Virus (HCV) or syphilis. 21. Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 06 months prior to study or used oral contraceptives within 14 days before dosing. 22. Female volunteer who demonstrates a positive pregnancy test. 23. Female study volunteer who is pregnant, breast-feeding or who is likely to become pregnant during the study. 24. Female using Hormonal IUD (Mirena), Norplant and other hormones, Depo-Provera, OCPs. (Females of child bearing age will be required to use 2 reliable forms of contraception such as condom and spermicidal or barrier method and spermicidal if sexually active. However, the use of Copper IUD or Tubal ligation are sufficient). **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ## 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: Diabetes Mellitus, Type 2 - 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 ### 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: M353561 - Name: Semaglutide - Relevance: HIGH - As Found: Carbohydrate - 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 ### Intervention Browse Module - Meshes - ID: C000591245 - Term: Semaglutide ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422611 **Acronym:** Digital **Brief Title:** Comparing Dental Impression Methods for Children **Official Title:** Comparison of Traditional and Digital Impression Methods for Pediatric Patients in Terms of Satisfaction #### Organization Study ID Info **ID:** Ege U. Ethical Com. 23-4.1/5 #### Organization **Class:** OTHER **Full Name:** Ege University ### Status Module #### Completion Date **Date:** 2023-08-20 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-05-30 **Type:** ACTUAL #### Start Date **Date:** 2023-04-20 **Type:** ACTUAL **Status Verified Date:** 2023-04 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-02-16 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ege University #### Responsible Party **Investigator Affiliation:** Ege University **Investigator Full Name:** Dilsah Cogulu **Investigator Title:** Professsor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The precision of dental restorations and the production of dental models has improved due to the acceleration of technical advancement and the introduction of computer-aided manufacturing. The study's objective is to compare the conventional imprint approach with a digital one in order to compare patients' comfort levels, preferences, and treatment times among pediatric patients. **Detailed Description:** In this study, 60 volunteers without any prior exposure to traditional or digital impressions took part. Using a C-type impression medium, conventional impressions of the maxillary and mandibular dental arches were taken. Digital impressions are taken using an intra-oral scanner at the same appointment. Following the impressions, a standardized questionnaire was used to assess the individuals' attitudes, preferences, and perceptions of the impression procedures. The Wong-Baker Pain Rating Scale was used to assess the perceived source of stress and Frankl Behavioural Scale was used for assessing behaviour. After taking the impression, the processing phases of the impression techniques (working time, etc.), and parental satisfaction were noted. ### Conditions Module **Conditions:** - Dental Impression, Pediatric Dentistry, Satisfaction ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 60 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Impression was taken with intraoral scanners **Intervention Names:** - Device: Impression methods **Label:** Digital #### Arm Group 2 **Description:** Impression was taken with silicone impression material **Intervention Names:** - Device: Impression methods **Label:** Conventional ### Interventions #### Intervention 1 **Arm Group Labels:** - Conventional - Digital **Description:** Both digital and conventional impressions were taken from same patients **Name:** Impression methods **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Parental satisfaction was measured with a structured questionnaire.The Wong-Baker Pain Rating Scale was used to assess the perceived source of stress and Frankl Behavioural Scale was used for assessing behaviour. A survey was designed to test 3 areas of patient satisfaction regarding the impression experience: comfort, time, and novelty. The survey consisted of 7 statements with a 100-mm visual analog scale (VAS) below each statement anchored with "agree" and "disagree." The survey also included questions to determine whether the patient had previous experience with impressions. **Measure:** Assessing patient preference and treatment comfort **Time Frame:** March 2023-June 2023 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * not to have a history of digital or conventional impression taking * not to have temporomandibular joint and periodontal discomfort * not to be using psychiatric or neuropathic drugs Exclusion Criteria: * history of digital or conventional impression taking * TMJ disorder * Using any kind of drug that interferes pain perception **Healthy Volunteers:** True **Maximum Age:** 12 Years **Minimum Age:** 7 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD **Study Population:** Patients who needed routine diagnostic records were included in our study. ### Contacts Locations Module #### Locations **Location 1:** **City:** Izmir **Country:** Turkey **Facility:** Ege University **Zip:** 35040 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422598 **Acronym:** BADAS **Brief Title:** Prevalence and Management Practice of Diabetic Kidney Disease at BADAS Affiliated Healthcare Centres in Bangladesh **Official Title:** Prevalence and Management Practice of Diabetic Kidney Disease at BADAS Affiliated Healthcare Centres in Bangladesh - An Exploratory Cross-Sectional Study #### Organization Study ID Info **ID:** BADAS-ERC/EC/24/23 #### Organization **Class:** OTHER **Full Name:** Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders #### Secondary ID Infos **Domain:** The Diabetic Association of Bangladesh (BADAS) **ID:** BADAS-ERC/EC/24/23 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2024-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-11 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Ibrahim Medical College #### Lead Sponsor **Class:** OTHER **Name:** Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders #### Responsible Party **Investigator Affiliation:** Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders **Investigator Full Name:** Wasim Md Mohosin Ul Haque **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:** Background: Diabetes is a growing public health concern in Bangladesh, with millions affected. Diabetic Kidney Disease (DKD) is a severe complication of diabetes, affecting approximately 21.3% of the diabetic population. To address this issue, a comprehensive assessment of DKD within the Bangladesh Diabetic Association\&#39;s (BADAS) affiliated healthcare centres is necessary. Objective: The study\&#39;s general objective is to determine the prevalence of DKD and evaluate its management at BADAS-affiliated healthcare centers. Specific objectives include assessing risk factors, screening practices, disease staging, management approaches, patient education, and providing evidence-based recommendations. Methodology: * Study Design: Cross-sectional * Study Population: All diabetic patients at BADAS-affiliated centers * Exclusion Criteria: Patients unwilling to participate or with kidney disease from other causes and with acute illness * Sample Size: \&#34;Forty patients will be selected from each center, resulting in a total sample size of 320 patients across eight centers, with one center randomly selected from each of the eight divisions in Bangladesh.\&#34; * Data Collection: Demographics, comorbidities, kidney function, blood pressure, HbA1c levels, medication records, treatment guideline adherence * Data Analysis: prevalence of diabetic kidney disease, factors affecting management, and potential barriers * Ethical Considerations: Ensure patient data privacy, obtain approvals, and informed consent Implications: The study aims to provide insights into the current state of magnitude (prevalence) of DKD, its management, highlighting areas for improvement in patient care, guideline adherence, and ultimately enhancing the well-being of diabetic patients in Bangladesh. **Detailed Description:** Background: Diabetes mellitus represents a significant public health challenge globally, and Bangladesh is no exception to this growing epidemic. According to the International Diabetes Federation (IDF), about 13.1 million people in Bangladesh have diabetes, and this number is expected to increase to 22.3 million by 2045(Sun et al., 2022). One of the most serious complications of diabetes is Diabetic Kidney Disease (DKD), which can lead to chronic kidney disease and end-stage renal disease (ESRD). DKD not only imposes a heavy burden on the healthcare system but also affects the economic and social well-being of the patients and their families. The prevalence of kidney disease among the diabetic population of Bangladesh is estimated to be around 21.3%. This number is based on a single center study conducted at the Bangladesh Institute of Health Sciences (BIHS) hospital in Dhaka, Bangladesh(Islam et al., 2021). This high prevalence highlights the need for a comprehensive evaluation of DKD within the centers affiliated with the Bangladesh diabetic association (BADAS), which is the largest non-governmental organization providing diabetes care and research in the country. The Bangladesh Diabetic Association (BADAS), with its extensive network of diabetes care centers and healthcare professionals, has long been at the forefront of addressing diabetes-related health concerns in the country. As a nation-wide institution dedicated to diabetes care, BADAS plays a pivotal role in delivering healthcare services and shaping the well-being of diabetic patients in Bangladesh. A comprehensive understanding of DKD prevalence and management status within BADAS centers is essential to enhance the quality of care for diabetic patients. Identifying areas for improvement is the first step towards effecting positive change. Our ultimate plan is to implement a nationwide DKD prevention program through affiliated diabetic centers. To achieve this, a comprehensive assessment of the current situation is an imperative foundation for program design, planning, and execution. The study will provide a rich dataset upon which evidence-based recommendations for preventing and managing DKD within BADAS-affiliated centers can be developed. These recommendations are essential for improving patient outcomes and ensuring the success of the future prevention program. In conclusion, the proposed study is a crucial undertaking aimed at addressing the pressing issue of DKD within the context of BADAS-affiliated healthcare centers. It serves as the first step towards the larger goal of implementing a nationwide DKD prevention program, with the potential to positively impact the health and well-being of diabetic patients across Bangladesh. Objective: General Objective: To determine the prevalence of diabetic kidney disease and assess the management status of diabetic kidney disease in patients attending affiliated healthcare centers of the Bangladesh Diabetic Associations. Specific Objectives: Determine the Prevalence of Diabetic Kidney Disease: Calculate the prevalence of DKD among diabetic patients visiting BADAS-affiliated healthcare centers using clinical and laboratory assessments. Assess Risk Factors for DKD: Identify and analyze demographic and clinical factors associated with the development of DKD in the study population. Evaluate Screening Practices: Evaluate the extent to which BADAS-affiliated healthcare centers conduct regular screening of registered diabetic patients for DKD and assess the effectiveness of current screening protocols. Characterize Disease Staging: Determine the stages of DKD among patients diagnosed with the condition and assess the proportion of patients with various stages of renal impairment. Analyze Management Approaches: Investigate the treatment modalities, including pharmacological interventions, lifestyle modifications, and patient education, used to manage DKD in the healthcare centers. Assess Healthcare Professional Awareness: Evaluate the awareness and knowledge of healthcare professionals working in BADAS-affiliated centres regarding DKD prevention, diagnosis, and management. Assess the infrastructural support of BADAS-affiliated centres regarding DKD prevention, diagnosis, and management. Examine Patient Education and Engagement: Assess the level of patient education and engagement in DKD management programs, including lifestyle modification guidance and adherence to treatment plans. Provide Recommendations: Based on the study findings, generate evidence-based recommendations for improving the prevention, early detection, and management of DKD in BADAS-affiliated healthcare centers to enhance the quality of care for diabetic patients. Material and Methodology: Study Design: Cross-sectional study design. Study Population: All registered diabetic patients receiving care at affiliated healthcare centres of Bangladesh Diabetic Associations. Exclusion criteria: Unwilling to participate in the study. Presence of AKI or acute illness Presence of Known kidney disease due to other cause. Sampling method: Multi-stage sampling. Sample size calculation: The formula to calculate the sample size: Where: n = required sample size Z = Z-score corresponding to the desired confidence level (e.g., 1.96 for a 95% confidence level) p = expected prevalence (in decimal form) E = margin of error (in decimal form) Expected prevalence of DKD to be 21.3% (0.213 in decimal form) Confidence level 95% Margin of error of 5% (0.05 in decimal form) Using these values, the sample size calculation would look like this: = 292 However, we will select forty patients from each centre, resulting in a total sample size of 320 patients across eight centres, with one centre will be randomly selected from each of the eight divisions in Bangladesh. Data Collection: Gather patient data, including demographics, comorbidities, kidney function (eGFR, UACR), blood pressure measurements, and HbA1c levels. Review medication records to determine the use of anti-proteinuric medications (e.g., ACE inhibitors, angiotensin receptor blockers, SGLT2i, nonsteroidal mineralocorticoids receptor antagonists and GLP analogues). Assess adherence to recommended treatment guidelines for diabetic kidney disease management. Collect data on healthcare professionals\&#39; awareness and knowledge of DKD prevention, diagnosis, and management. Gather data on the infrastructure available in BADAS-affiliated centres for DKD prevention, diagnosis, and management. Screening for the presence of DKD The diagnostic criteria for diabetic kidney disease (DKD)(McGrath and Edi, 2019, ElSayed et al., 2022): DKD is usually a clinical diagnosis in a patient with long-standing diabetes (\&gt;10 years) with albuminuria and/or reduced eGFR in the absence of signs or symptoms of other primary causes of kidney damage. Albuminuria: Increased urinary albumin excretion is defined as ≥30 mg/g. (2 out of 3 in 3 to 6 months). Reduced estimated Glomerular Filtration Rate (eGFR): \&lt;60ml/minute/1.73m2. for more than 3 months Duration of Diabetes: DKD is typically associated with a long duration of diabetes (\&gt;10 years' duration of type 1 diabetes; may be present at diagnosis in type 2 diabetes). Presence of Retinopathy: DKD is typically associated with retinopathy however the absence of retinopathy does not exclude DKD in type 2 diabetes. Data Analysis: Evaluate the proportion of patients achieving target blood pressure control (e.g., \&lt;130/80 mm Hg), glycaemic control (e.g., HbA1c \&lt;7%), and receiving appropriate anti-proteinuric medications. Examine factors associated with successful management, including age, gender, duration of diabetes, and comorbidities. Identify potential barriers to achieving optimal management. Ethical Considerations: Ensure patient data privacy and confidentiality. Obtain necessary approvals and informed consent for data access and analysis. Implications: Provide insights into the current magnitude and state of diabetic kidney disease management, specifically focusing on blood pressure and glycaemic control and the utilization of anti-proteinuric medications among diabetic patients. Highlight areas for improvement in patient care and guideline adherence to enhance diabetic kidney disease management. ### Conditions Module **Conditions:** - Diabetic Kidney Disease **Keywords:** - diabetes - Diabetic kidney disease - Prevalence - management ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 320 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Calculate the prevalence of DKD among diabetic patients visiting BADAS-affiliated healthcare centers using clinical and laboratory assessments. **Measure:** Prevalence of diabetic kidney disease **Time Frame:** Day 1 #### Secondary Outcomes **Description:** Identify and analyze demographic and clinical factors associated with the development of DKD in the study population. **Measure:** Risk Factors for DKD **Time Frame:** Day 1 **Description:** Evaluate the extent to which BADAS-affiliated healthcare centers conduct regular screening of registered diabetic patients for DKD and assess the effectiveness of current screening protocols. **Measure:** Screening Practices **Time Frame:** Day 1 **Description:** Investigate the treatment modalities, including pharmacological interventions, lifestyle modifications, and patient education, used to manage DKD in the healthcare centers. **Measure:** Management Approaches **Time Frame:** Day 1 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: • All registered diabetic patients receiving care at affiliated healthcare centres of Bangladesh Diabetic Associations. Exclusion Criteria: * Unwilling to participate in the study. * Presence of AKI or acute illness * Presence of Known kidney disease due to other cause. * Pregnancy **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** We will select forty patients from each centre, resulting in a total sample size of 320 patients across eight centres, with one centre will be randomly selected from each of the eight divisions in Bangladesh ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Wasim MM Haque, MBBS, FCPS **Phone:** +8801915472750 **Role:** CONTACT #### Locations **Location 1:** **City:** Chapainawabganj **Contacts:** ***Contact 1:*** - **Name:** Khokon - **Role:** CONTACT **Country:** Bangladesh **Facility:** Chapainawabganj Diabetes Center **Status:** RECRUITING **Location 2:** **City:** Cox's Bazar **Contacts:** ***Contact 1:*** - **Name:** Bivision - **Role:** CONTACT **Country:** Bangladesh **Facility:** Cox's Bazar Diabetic Hospital **Status:** RECRUITING **Location 3:** **City:** Meherpur **Contacts:** ***Contact 1:*** - **Name:** Jiptaho - **Role:** CONTACT **Country:** Bangladesh **Facility:** Meherpur diabetes hospital **Status:** NOT_YET_RECRUITING **Location 4:** **City:** Narayanganj **Contacts:** ***Contact 1:*** - **Name:** Rafiq - **Role:** CONTACT **Country:** Bangladesh **Facility:** Narayanganj Diabetic Hospital **Status:** RECRUITING **Location 5:** **City:** Panchagarh **Contacts:** ***Contact 1:*** - **Name:** Rowshan - **Role:** CONTACT **Country:** Bangladesh **Facility:** Diabetic Hospital Panchagarh **Status:** NOT_YET_RECRUITING **Location 6:** **City:** Pirojpur **Contacts:** ***Contact 1:*** - **Name:** Uzzal - **Role:** CONTACT **Country:** Bangladesh **Facility:** Pirojpur Diabetic Samiti **Status:** NOT_YET_RECRUITING **Location 7:** **City:** Rajbari **Contacts:** ***Contact 1:*** - **Name:** Shahid - **Role:** CONTACT **Country:** Bangladesh **Facility:** Rajbari Diabetes Center **Status:** RECRUITING **Location 8:** **City:** Sherpur **Contacts:** ***Contact 1:*** - **Name:** Ashish - **Role:** CONTACT **Country:** Bangladesh **Facility:** Sherpur Diabetic Hospital **Status:** NOT_YET_RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders **Name:** Wasim MM Haque, MBBS, FCPS **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Jeffrie Seley J, Stanton RC, Gabbay RA, on behalf of the American Diabetes Association. 15. Management of Diabetes in Pregnancy: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Suppl 1):S254-S266. doi: 10.2337/dc23-S015. **PMID:** 36507645 **Citation:** Islam SMS, Salehin M, Zaman SB, Tansi T, Gupta RD, Barua L, Banik PC, Uddin R. Factors Associated with Chronic Kidney Disease in Patients with Type 2 Diabetes in Bangladesh. Int J Environ Res Public Health. 2021 Nov 23;18(23):12277. doi: 10.3390/ijerph182312277. **PMID:** 34886001 **Citation:** McGrath K, Edi R. Diabetic Kidney Disease: Diagnosis, Treatment, and Prevention. Am Fam Physician. 2019 Jun 15;99(12):751-759. **PMID:** 31194487 **Citation:** Sun H, Saeedi P, Karuranga S, Pinkepank M, Ogurtsova K, Duncan BB, Stein C, Basit A, Chan JCN, Mbanya JC, Pavkov ME, Ramachandaran A, Wild SH, James S, Herman WH, Zhang P, Bommer C, Kuo S, Boyko EJ, Magliano DJ. IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract. 2022 Jan;183:109119. doi: 10.1016/j.diabres.2021.109119. Epub 2021 Dec 6. Erratum In: Diabetes Res Clin Pract. 2023 Oct;204:110945. **PMID:** 34879977 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000048909 - Term: Diabetes Complications - ID: D000003920 - Term: Diabetes Mellitus - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: HIGH - As Found: Kidney Disease - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M7123 - Name: Diabetic Nephropathies - Relevance: HIGH - As Found: Diabetic Kidney Disease - 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: M26004 - Name: Diabetes Complications - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007674 - Term: Kidney Diseases - ID: D000003928 - Term: Diabetic Nephropathies ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422585 **Brief Title:** Comparison of Different Analgesic Nerve Blocks in Total Knee Replacement Surgery **Official Title:** Comparison of Three Different Analgesic Nerve Blocks in Total Knee Replacement Surgery #### Organization Study ID Info **ID:** PGBLOCK #### Organization **Class:** OTHER **Full Name:** Azienda Ospedaliero, Universitaria Pisana ### Status Module #### Completion Date **Date:** 2025-02 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-02 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-04-26 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Azienda Ospedaliero, Universitaria Pisana #### Responsible Party **Investigator Affiliation:** Azienda Ospedaliero, Universitaria Pisana **Investigator Full Name:** Serena Ricalzone **Investigator Title:** principal investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this observational study is to compare the equivalent analgesic efficacy of three regional anesthesia techniques in total knee replacement surgery. The main question it aims to answer is: • Non inferiority of each technique in relation to the others Participants will receive selective spinal anesthesia and the antalgic nerve block depending on the group they happen to be in. Researchers will compare the Femoral Nerve Group+IPACK block, the Saphenous Nerve block+IPACK and the Subsartorial Block groups to see if there is any difference in the pain control in the 24 hours after the surgery. **Detailed Description:** After adequate venous access is obtained, a light sedation with Midazolam 1-2 mg is administered. The patient will be monitored and a selective spinal anesthesia will be performed. After the neuraxial procedure the antalgic block of choice is performed with about 40 mL of long acting local anesthetic. Magnesium Solfate 1g and Dexametasone 4mg are administered after the block. If the patient wishes, a propofol continuos infusion may be administered for sedation during the surgery. Before the patient leaves the OR, Ketorolac 30mg will be administered. Pain control after surgery will be achieved with acetaminophen 1g t.i.d., Ketorolac 30mg on demand, and Morphine solfate if NRS \>5 after Ketorolac. Every 6 hours the patient will be monitored by the anesthesia team. After 24 hours the antalgic effect of the nerve block is reasonably thought to be over, so the follow up is interrupted. ### Conditions Module **Conditions:** - Knee Prosthesis - Pain, Procedural **Keywords:** - Knee - Post procedural pain - Regional anesthesia ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 180 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** After adequate venous access has been obtained, spinal anesthesia with Levobupivacaine will be performed. After which antalgic Femoral Nerve Block and IPACK Block will be performed. **Label:** Femoral Nerve Block + IPACK Block #### Arm Group 2 **Description:** After adequate venous access has been obtained, spinal anesthesia with Levobupivacaine will be performed. After which Saphenous and IPACK Block will be performed. **Label:** Saphenous (Adductor Canal) Block + IPACK Block #### Arm Group 3 **Description:** After adequate venous access has been obtained, spinal anesthesia with Levobupivacaine will be performed. After which Dual Subsartorial Block will be performed. **Label:** Dual Subsartorial Block ### Outcomes Module #### Primary Outcomes **Description:** To compare the analgesic effect at 24 hours, of a nerve block technique compared to others after selective spinal anesthetic is administerd to achieve surgical anesthesia.Evaluate pain for every group in the first 24 hours post surgery using the Numeric Pain Scale (NRS) assigning a numeric value between zero (no pain) and ten (the worst pain ever felt). Absence of relevant pain is considered a NRS less than three. Success of the block was defined as NRS≤3. **Measure:** NRS **Time Frame:** Baseline, every 6 hours for the first 24 hours after surgery #### Secondary Outcomes **Description:** Monitoring the onset of side effects (nausea/vomiting/hypotension/dizziness/sensitive impareiment) in every group of patients in the first 24 hours every six hours **Measure:** side effect **Time Frame:** 24 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age \> 18 y/o * Total knee replacement elective surgery * Informed consent Exclusion Criteria: * Age \< 18 y/o * Surgery with general anesthesia * Patients with coagulopaties * Patients in chronic opioid therapy * Refuse to sign informed consent form * Unable to sign informed consent form * Know allergies to medication used for analgesia **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** All patients meeting the inclusion criteria ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Serena Ricalzone, MD **Phone:** 050.997881 **Role:** CONTACT #### Locations **Location 1:** **City:** Pisa **Contacts:** ***Contact 1:*** - **Name:** Serena Ricalzone, MD - **Phone:** 050.997881 - **Role:** CONTACT **Country:** Italy **Facility:** Edificio 3 - Azienda Ospedaliero Universitaria Pisana Cisanello **State:** Toscana **Status:** RECRUITING **Zip:** 56124 #### Overall Officials **Official 1:** **Affiliation:** Azienda Ospedaliera Universitaria Pisana **Name:** Silvia Nardi, MD **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Scuola Specializzazione - Università di Pisa **Name:** Alessandro Cardu, MD **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M1219 - Name: Pain, Procedural - Relevance: HIGH - As Found: Pain, Procedural - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000073818 - Term: Pain, Procedural ### 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: M1832 - Name: Levobupivacaine - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422572 **Brief Title:** Tissue Kallikrein Protect Against Ischemic Stroke **Official Title:** The Role of Tissue Kallikrein - Bradykinin System Targeting the Protection of Neurovascular Units in Ischemic Areas of Stroke #### Organization Study ID Info **ID:** TJ-IRB202303109 #### Organization **Class:** OTHER **Full Name:** Tongji Hospital ### Status Module #### Completion Date **Date:** 2023-12-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-18 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-12-30 **Type:** ACTUAL #### Start Date **Date:** 2023-05-01 **Type:** ACTUAL **Status Verified Date:** 2023-03 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-18 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** National Natural Science Foundation of China #### Lead Sponsor **Class:** OTHER **Name:** Qin Zhang #### Responsible Party **Investigator Affiliation:** Tongji Hospital **Investigator Full Name:** Qin Zhang **Investigator Title:** PROFESSOR **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The results of previous studies were used to assess the causal association between TK levels and stroke occurrence at 5 and 12 years of follow-up, respectively. **Detailed Description:** Analyze the data of a 5-year follow-up on 2115 control individuals from the case-control study of the previous research. We completed the 5-year follow-up on this group in 2016 (whether they had a stroke, whether they are alive, and the cause of death). Conduct a 12-year follow-up on 6487 community individuals from the previous study (whether they had a stroke within 12 years, whether they are alive, and the cause of death). We collaborated with the hospital platform's computer center to conduct follow-up through AI questionnaire surveys, followed by supplementing AI questionnaire data with telephone questionnaire surveys for those lost to follow-up. Utilize R language R Studio 4.11 for statistical analysis and plotting. Evaluate the distribution of TK levels in the control group and its relationship with the 10-year predicted risk of stroke and the predictive role for stroke events within 5 years. Evaluate the distribution of TK levels in the community group and its relationship with the 10-year predicted risk of stroke and the predictive role for stroke events within 12 years. ### Conditions Module **Conditions:** - Stroke, Ischemic **Keywords:** - Stroke ### Design Module #### Bio Spec **Description:** Part of the sample consisted of 1210 stroke controls and 905 coronary heart disease controls enrolled from December 2000 to November 2001 in the previous study. The other part comes from 6,487 cases of community population in Rizhao area from May to August 2010. **Retention:** NONE_RETAINED #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 8602 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 1. Control population in a case-controlled study of prior stroke ; 2. Control population in a case-controlled study of preexisting coronary heart disease; 3. Population in previous community cross-sectional studies . **Intervention Names:** - Other: No Intervention **Label:** Population without stroke ### Interventions #### Intervention 1 **Arm Group Labels:** - Population without stroke **Description:** No Intervention **Name:** No Intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The primary outcome measure will be the occurrence of stroke during the 5-year follow-up period. Stroke events will be assessed and recorded based on predetermined diagnostic criteria, such as clinical symptoms, imaging findings, and/or medical records review. The data will be aggregated and reported as the total number of stroke cases observed in the study population. **Measure:** Incidence of Stroke **Time Frame:** 5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 1) Control population in the previous stroke case-control study; * 2) The CHD case-control population in the previous study; * 3) The population in the community cross-sectional study of the previous study. Exclusion Criteria: * Stroke patient **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** 1. Control population in the previous stroke case-control study; 2. The CHD case-control population in the previous study; 3. The population in the community cross-sectional study of the previous study. ### Contacts Locations Module #### Locations **Location 1:** **City:** Wuhan **Country:** China **Facility:** Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology **State:** Hubei **Zip:** 430030 #### Overall Officials **Official 1:** **Affiliation:** Tongji Hospital **Name:** QIN Zhang, phd **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002561 - Term: Cerebrovascular Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases ### Condition Browse Module - Browse Leaves - ID: M10543 - Name: Ischemia - Relevance: HIGH - As Found: Ischemic - ID: M22306 - Name: Stroke - Relevance: HIGH - As Found: Stroke - ID: M2400 - Name: Ischemic Stroke - Relevance: HIGH - As Found: Stroke, Ischemic - 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 - ID: D000083242 - Term: Ischemic Stroke - ID: D000007511 - Term: Ischemia ### Intervention Browse Module - Browse Branches - Abbrev: Coag - Name: Coagulants - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: VaDiAg - Name: Vasodilator Agents ### Intervention Browse Module - Browse Leaves - ID: M10638 - Name: Kallikreins - Relevance: LOW - As Found: Unknown - ID: M5197 - Name: Bradykinin - Relevance: LOW - As Found: Unknown - ID: M10725 - Name: Kininogens - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422559 **Brief Title:** Accelerated Intermittent Theta Burst Stimulation in Unipolar Versus Bipolar Depression **Official Title:** Accelerated Intermittent Theta Burst Stimulation in Unipolar Versus Bipolar Depression #### Organization Study ID Info **ID:** MD.22.12.731 #### Organization **Class:** OTHER **Full Name:** Mansoura University ### Status Module #### Completion Date **Date:** 2025-01-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-18 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-04-23 **Study First Submit QC Date:** 2024-05-18 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mansoura University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** True ### Description Module **Brief Summary:** The goal of this interventional study is to learn if accelerated Intermittent Theta Burst Stimulation can improve symptoms of 30 participants with Unipolar depression in higher manner than symptoms of 30 participants with bipolar depression **Detailed Description:** We will apply stimulatory TMS protocol for participants with Unipolar depression and participants with bipolar depression using MagVenture MagPro R30 stimulator with the Cool-B65 coil ### Conditions Module **Conditions:** - Depressive Disorder ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants with Unipolar depression will receive 30 sessions of TMS.10 sessions a week for 3 weeks **Intervention Names:** - Device: Transmagnetic stimulation - Device: TMS **Label:** Participants with unipolar depression **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants with bipolar depression will receive 30 sessions of TMS.10 sessions a week for 3 weeks **Intervention Names:** - Device: Transmagnetic stimulation - Device: TMS **Label:** Participants with bipolar depression **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Participants with bipolar depression - Participants with unipolar depression **Description:** Stimulatory TMS protocol using MagVenture MagPro R30 stimulator with the Cool-B65 coil **Name:** Transmagnetic stimulation **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Participants with bipolar depression - Participants with unipolar depression **Description:** Stimulatory TMS protocol using MagVenture MagPro R30 stimulator with the Cool-B65 coil **Name:** TMS **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** We will use Young Mania Rating Scale._Young Mania Rating Scale:assess severity of manic symptoms, clinician rated,\<=12(remission)13_19(minimal symptoms)20_25(mild mania)26_37(moderate mania)38_60 severe mania **Measure:** Comparison of severity of manic symptoms before and after treatment **Time Frame:** One year for completion of the study **Description:** We will use Clinical Global Impression Severity Scale._Clinical Global Impression Severity Scale:rate the severity of the patient's illness at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis,1 normal not at all ill,2 borderline mentally ill,3 mildly ill,4 moderately ill,5 markedly ill,6 severely ill,7 extremely ill **Measure:** Comparison of the severity of the patient's illness at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis. **Time Frame:** One year for completion of the study **Description:** We will use Insomnia Severity Index scale._Insomnia Severity Index:assess the nature, severity and impact of insomnia,0_7(absence insomnia) 8_14(subthreshold insomnia)15_21(moderate insomnia)22_28(severe insomnia) **Measure:** Comparison of severity and impact of insomnia before and after treatment **Time Frame:** One year for completion of the study **Description:** We will use Hamilton Depression Rating Scale._Hamilton Depression Rating Scale:assess the severity of depressive symptoms, clinician rated,0_7(normal range)8_16(mild severity)17_23(moderate severity)\>23(severe depression) **Measure:** Comparison of depressive symptoms before and after treatment **Time Frame:** One year for completion of the study ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age:18_65 years * Sex:male and female * Patients with Unipolar depression and bipolar depression diagnosis confirmed by SCID according to DSM5 * No pharmacological change in the last 4 weeks before the beginning of the stimulantion cycle * Pharmacological resistance Exclusion Criteria: * Patients complaining of psychosis.Substance Use Disorder.current suicidal ideation.major medical and neurological disorder * Patients complaining of epilepsy * pregnancy and breastfeeding * peacemaker spinal or bladder stimulator * History of skull surgery and trauma * presence of metallic foreign body **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Shaimaa E. Mohamed **Phone:** Egypt 01014947026 **Role:** CONTACT **Contact 2:** **Name:** Warda F. Aboelez **Phone:** 01018186408 **Role:** CONTACT #### Locations **Location 1:** **City:** Mansoura **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Institutional R. Board - **Phone:** Egypt +2050-2202773:2202746 - **Role:** CONTACT ***Contact 2:*** - **Name:** Warda F. Aboelez - **Phone:** 01018186408 - **Role:** CONTACT ***Contact 3:*** - **Name:** Shaimaa E. Mohamed - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Egypt **Facility:** Mansoura University **Zip:** 35516 #### Overall Officials **Official 1:** **Affiliation:** Professor **Name:** Hala A. El-boraie **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** Assistant professor **Name:** Ibrahim H. Rashed **Role:** STUDY_DIRECTOR **Official 3:** **Affiliation:** Lecturer **Name:** Hassan M. Sonbol **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Chang J, Chu Y, Ren Y, Li C, Wang Y, Chu XP. Maintenance treatment of transcranial magnetic stimulation (TMS) for treatment-resistant depression patients responding to acute TMS treatment. Int J Physiol Pathophysiol Pharmacol. 2020 Oct 15;12(5):128-133. eCollection 2020. **PMID:** 33224435 #### See Also Links **Label:** PMC 7675193 **URL:** https://pubmed.ncbi.nlm.nih.gov/33224435/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000068105 - Term: Bipolar and Related Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depressive Disorder - ID: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M4996 - Name: Bipolar Disorder - Relevance: HIGH - As Found: Bipolar Depression - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M226 - Name: Bipolar and Related Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003866 - Term: Depressive Disorder - ID: D000001714 - Term: Bipolar Disorder ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422546 **Acronym:** pre-FLAME **Brief Title:** A Prospective, Multicenter, Non-interventional, Real-world Study to Characterize Changes in Molecular Markers After Three Weeks of Targeted Therapy With Oxitinib in EGFRm NSCLC **Official Title:** A Prospective, Multicenter, Non-interventional, Real-world Study to Characterize Changes in Molecular Markers After Three Weeks of Targeted Therapy With Oxitinib in Chinese Patients With Stage IV Metastatic or Recurrent Non-squamous EGFR-positive NSCLC #### Organization Study ID Info **ID:** pre-FLAME #### Organization **Class:** OTHER **Full Name:** Beijing Cancer Prevention & Treatment Society ### Status Module #### Completion Date **Date:** 2025-06-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-31 **Type:** ESTIMATED #### Start Date **Date:** 2022-01-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences #### Lead Sponsor **Class:** OTHER **Name:** Beijing Cancer Prevention & Treatment Society #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** To evaluate the characteristics of genetic variationmutations at baseline and 3 weeks after oxitinib treatment in EGFRm NSCLC **Detailed Description:** Characteristics of EGFR gene mutation and efficacy of oxitinib treatment at baseline and after 3 weeks of treatment.To evaluate the mechanism of oxitinib treatment resistance and describe the characteristics of genetic variation associated with oxitinib treatment at baseline and 3 weeks after treatment. ### Conditions Module **Conditions:** - Non Small Cell Lung Cancer ### Design Module #### Bio Spec **Description:** EGFR mutation in plasma **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 950 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Other Outcomes **Description:** To evaluate the mechanism of oxitinib treatment resistance and describe the characteristics of genetic variation associated with oxitinib treatment at baseline and 3 weeks after treatment **Measure:** describe the characteristics of genetic variation associated with oxitinib treatment **Time Frame:** baseline and 3 weeks after oxitinib treatment #### Primary Outcomes **Description:** To characterize the changes in EGFR gene mutations at baseline and 3 weeks after oxitinib treatment **Measure:** changes in EGFR gene mutations **Time Frame:** baseline and 3 weeks after oxitinib treatment #### Secondary Outcomes **Description:** Characteristics of EGFR gene mutation and efficacy of oxitinib treatment at baseline and after 3 weeks of treatment **Measure:** Characteristics of EGFR gene mutation and efficacy of oxitinib treatment **Time Frame:** baseline and 3 weeks after oxitinib treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. ≥18 years old male or female 2. Stage IV metastatic or recurrent non-squamous NSCLC that is newly diagnosed, histologically proven and not suitable for radical surgery or radiotherapy (AJCC V8); 3. Without prior systemic antitumor therapy including EGFR-TKI or immunotherapy; 4. EGFR positive in blood or tissue tested in local laboratory; 5. Sufficient blood samples can be provided for molecular detection; 6. Signed informed consent forms are available. Exclusion Criteria: 1. Patients were unable to collect plasma samples at baseline; 2. The EGFR mutant status of the patient's blood specimen at baseline has not been verified by the central laboratory; 3. The patient refused subsequent treatment with oxitinib; 4）The investigator determines that may affect the conduct of the clinical study and the judgement of the study results. **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** stage IV metastatic or recurrent non-squamous EGFR-positive NSCLC ### Contacts Locations Module #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Qu Liudi - **Phone:** 18519773872 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Du Xueying - **Phone:** 18811792675 - **Role:** CONTACT **Country:** China **Facility:** Beijing Cancer Prevention society **State:** Beijing **Status:** RECRUITING **Zip:** 100021 ### 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: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases ### Condition Browse Module - Browse Leaves - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - 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:** NCT06422533 **Brief Title:** Ceftolozane/Tazobactam vs. Piperacillin/Tazobactam for the Treatment of Bacteremia in Hemato-oncological Patients **Official Title:** Ceftolozane/Tazobactam vs. Piperacillin/Tazobactam for the Treatment of Bacteremia Due to Enterobacteriaceae and Pseudomonas Aeruginosa in Hemato-oncological Patients With Severe Neutropenia and Fever: Non-inferiority Study #### Organization Study ID Info **ID:** CI0565-2023 #### Organization **Class:** OTHER **Full Name:** Instituto Nacional de Cancerologia de Mexico ### Status Module #### Completion Date **Date:** 2025-08-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-02 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-07-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-11-07 **Type:** ACTUAL **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-04-25 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Instituto Nacional de Cancerologia de Mexico #### Responsible Party **Investigator Affiliation:** Instituto Nacional de Cancerologia de Mexico **Investigator Full Name:** Patricia Cornejo Juarez **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:** Patients with hematological malignancies receive highly myelotoxic chemotherapy regimens that cause periods of severe myelosuppression, which places them at high risk of developing bacteremia. At a global level, a very significant increase in multidrug-resistant (MDR) Gram-negative microorganisms, particularly Enterobacteriaceae producing extended-spectrum beta-lactamases (ESBL) and MDR P.aeruginosa, have been described during the last decade. Among the strategies to reduce bacterial resistance, ceftolozane/tazobactam (C/T) as a "carbapenem-sparing" antibiotic has been proposed. C/T has broad-spectrum activity since it has action against ESBL-producing Enterobacteriaceae and MDR P. aeruginosa. Studies carried out in the real world using this antibiotic in patients with hematological malignancies have demonstrated clinical success in reports and case series, considered a therapeutic option in patients with Enterobacteriaceae and P. aeruginosa infections, particularly in MDR pathogens. At the National Cancer Institute (in Spanish, Instituto Nacional de Cancerologia), Gram-negative bacilli have been identified for more than 20 years as the pathogens most frequently associated with bacteremia. Escherichia coli occupies the first place in 25% (41% ESBL), followed by Klebsiella spp. in 5.6% (11.2% ESBL) and P. aeruginosa in 5.6% (11.2% MDR). The protocol for approaching and treating hematological malignancy patients with severe neutropenia and fever is to initiate an antimicrobial regimen with piperacillin/tazobactam (P/T). In patients who persist with fever after 48 to 72 hours of starting antibiotics, who present with clinical deterioration, or in whom P/T-resistant bacteria are identified, this is escalated to carbapenem. Therefore, it is proposed to compare the clinical and microbiological response in patients with hematological malignancies who present with severe neutropenia and fever and who present clinical data of bacteremia, with empirical treatment with C/T vs. P/T, trying to reduce the use of carbapenems in this group of patients. **Detailed Description:** At a global level, a very significant increase in multidrug-resistant (MDR) Gram-negative microorganisms has been described during the last decade, particularly Enterobacteriaceae producing extended-spectrum beta-lactamases (ESBL) and MDR Pseudomonas aeruginosa. This is directly related to the use of broad-spectrum antimicrobials, particularly carbapenems. Among the strategies to reduce bacterial resistance, using ceftolozane/tazobactam (C/T) as a "carbapenem-sparing" antibiotic is proposed. C/T has been administered in hemato-oncological patients with severe neutropenia, colonized by resistant strains in centers with a high prevalence of Enterobacteriaceae-ESBL and P. aeruginosa MDR. The study's purpose is to demonstrate non-inferiority between ceftolozane/tazobactam vs. piperacillin/tazobactam for patients with hematological malignancies who present severe neutropenia and fever, including those patients who have bacteremia due to Enterobacteriaceae and Pseudomonas aeruginosa. C/T is a combination antibiotic with a new cephalosporin, structurally similar to ceftazidime, plus tazobactam. The FDA approved This known beta-lactamase inhibitor in 2018 to treat intra-abdominal and complicated urinary infections. In 2019, its indication was expanded to nosocomial pneumonia and those associated with mechanical ventilation. In Mexico, it was approved for marketing in June 2019. C/T has broad-spectrum activity since it has action against ESBL-producing Enterobacteria and MDR P. aeruginosa. Studies carried out in the real world using this antibiotic in patients with hematological malignancies have demonstrated clinical success in reports and case series, considered a therapeutic option in patients with Enterobacteriaceae and P. aeruginosa infections, particularly in MDR pathogens. At the National Cancer Institute, Gram-negative bacilli have been identified for more than 20 years as the pathogens most frequently associated with bacteremia, with Escherichia coli occupying first place at 25% (41% ESBL), followed by Klebsiella sp. in 5.6% (11.2% ESBL), and P. aeruginosa in 5.6% (11.2% MDR). The protocol for approaching and treating hemato-oncological patients with severe neutropenia and fever is to initiate an antimicrobial regimen with piperacillin/tazobactam (P/T) if they are hemodynamically stable. In patients who persist with fever after 48 to 72 hours of starting antibiotics, who present with clinical deterioration, or in whom P/T-resistant bacteria are identified, this is escalated to a carbapenem (usually meropenem). A randomized, open, non-inferiority clinical trial comparing 1:1 two antibiotics, P/T vs. C/T, for the treatment of severe neutropenia and fever and/or developing Enterobacteriaceae or P. aeruginosa bacteremia in patients with hematologic malignancies Methodological strategies All patients who come to the National Cancer Institute with signs of severe neutropenia (polymorphonuclear cells \<500 cells/mm3) and fever (≥38.3 degrees Celsius in one measure or ≥38 degrees Celsius in at least two measures) will be considered for inclusion. Blood cultures will be taken upon admission (catheter and peripheral in those with the same), or two peripherals with a difference of 15 minutes between each one. Blood cultures will be requested before signing the informed consent since they are part of the initial approach to these patients, regardless of whether they enter the study. They will be taken before the administration of antimicrobials. Medical staff from the infectious disease department will evaluate the inclusion and exclusion criteria and invite the candidate to the study. If the patient accepts, they will be provided informed consent to review it in detail, explaining any doubts. If they agree to participate, the corresponding signatures will be made. Randomization will be done based on a stratified method in two groups: Group 1, patients with leukemia, and Group 2, patients with other hemato-oncological pathologies. They will be randomized into ten blocks and divided into the two groups above. The administration of the P/T or C/T antimicrobial regimen will begin depending on the group to which they have been assigned, following the manufacturer's instructions and according to the administration standards at INCan. The clinical and microbiological response will be evaluated in the first 72-96 hours (taking randomization as day +1), defined as patient survival plus resolution of fever plus sterilization of blood cultures (taken within the first 72-96 hours). If patients have been fever-free for at least 48 hours and have no growth in blood cultures, they will receive at least five days of antibiotic treatment. The administration time will be at least seven days in patients with P. aeruginosa or Enterobacteriaceae growth in blood cultures. Patients whose blood cultures report growth of bacteria different from the previous ones, yeast, or polymicrobial growth will be excluded from the study. Treatment failure will be considered, and the following will be included in the intention-to-treat analysis: * If the growth in the blood culture is Enterobacteriaceae or P. aeruginosa, resistant to the antibiotic assigned. * There is growth of the same bacteria in control blood cultures taken 72-96 hours after starting antibiotics. * If, during treatment, the patient presents signs of hemodynamic instability, respiratory failure, clinical deterioration, or septic shock, changing the antimicrobial regimen will be considered. The following will be considered a relapse and will be included in the intention-to-treat analysis: * When the same microorganism is isolated at the beginning, it grows in blood cultures after having negative blood cultures. * Or in the first 30 days after completing the antibiotic regimen, considering the resolution of the primary infectious focus. During treatment, they will not be able to receive any other Gram-negative antibiotic except prophylaxis against P. jirovecii (400/80 mg/day TMP/SMX or 800/160 mg every 48 h). The number of days of antibiotics will be counted. It will be documented when an antibiotic is modified and the reason for the change (microbiological failure, clinical deterioration, drug-related adverse events, and others). The appearance of diarrhea will be monitored, and Glutamate dehydrogenase (GDH) and toxin for Clostridiodes difficile will be requested. Patients will be evaluated daily until fever resolution and until hospital discharge (if this occurs in the first 14 days), recording fever and adverse events, including diarrhea, leukocytes, and neutrophils. Follow-up will be carried out until day +30 from the patient's inclusion in the study. If the patient is discharged before this date, a telephone call will be made on day +30 to verify the clinical status. The evolution will be classified as alive without infection, alive with clinical or microbiological data of infection, also considering C. difficile infection, dead from infection without neutropenia, dead from infection with neutropenia, dead from terminal illness, or dead from another cause. ### Conditions Module **Conditions:** - Hematologic Neoplasms - Neutropenia **Keywords:** - ceftolozane/tazobactam - piperacillin/tazobactam - neutropenia - hematologic neoplasms ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized, open, non-inferiority clinical trial comparing 1:1 two antibiotics, piperacillin/tazobactam vs. ceftolozane/tazobactam ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 226 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Ceftozolane/tazobactam (C/T) is a combination antibiotic with a new cephalosporin, structurally similar to ceftazidime, plus tazobactam. The FDA approved This known beta-lactamase inhibitor in 2018 to treat intra-abdominal and complicated urinary infections. In 2019, its indication was expanded to nosocomial pneumonia and those associated with mechanical ventilation. In Mexico, it was approved for marketing in June 2019. C/T has broad-spectrum activity since it has action against ESBL-producing Enterobacteria and MDR P. aeruginosa. Studies carried out in the real world using this antibiotic in patients with hematological malignancies have demonstrated clinical success in reports and case series, considered a therapeutic option in patients with Enterobacteriaceae and P. aeruginosa infections, particularly in MDR pathogens. **Intervention Names:** - Drug: Ceftolozane/tazobactam **Label:** Ceftolozane/tazobactam **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** At our hospital, Piperacillin/tazobactam is the primary drug used as an empirical treatment in patients with severe neutropenia and fever, according to Clinical Practice Guidelines for the use of antimicrobial agents in neutropenic patients with cancer. **Intervention Names:** - Drug: Piperacillin/tazobactam **Label:** Piperacillin/tazobactam **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Ceftolozane/tazobactam **Description:** Ceftolozane/tazobactam 1.5 g tid IV infusion for 1 hour during 5 to 7 days **Name:** Ceftolozane/tazobactam **Other Names:** - Zerbaxa **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Piperacillin/tazobactam **Description:** Piperacillin/tazobactam 4.5 g qid IV infusion for 30 minutes during 5 to 7 days **Name:** Piperacillin/tazobactam **Other Names:** - Tazocin - Pipertazo - Tazonam - Tazovak **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Number of patients who develop diarrhea or abdominal pain or distended abdomen, with a test positive for C. difficile (toxin/GDH C. difficile test). **Measure:** Clostridioides difficile infection documented through toxin/GDH C. difficile test in those patients who develop diarrhea, abdominal pain and/or distended abdomen. **Time Frame:** Day 1 to day 30 #### Primary Outcomes **Description:** To assess the number of patients who will be alive or dead in the first 30 days. On day 30, a physical visit will be made to the patient's bedside if the patient is hospitalized. If the patient is not hospitalized, the clinical record will be evaluated, and one of the investigators will make a phone call to ensure the patient's status for that date. **Measure:** Mortality of all patients at day 30 **Time Frame:** Day 30 #### Secondary Outcomes **Description:** Number of patients that will have repeated blood cultures sterilized (no growth of the same bacteria isolated in the first set of blood cultures taken in day 1). **Measure:** Microbiological response through the sterilization of repeated blood cultures take **Time Frame:** Day 3 to day 4 **Description:** The presence of fever (\>38 Celsius degree) will be evaluated according to nursing records that are carried out three times a day (morning, afternoon, and night shifts). Clinical failure will be considered when the patient persists with fever (\>38 Celsius degrees) on day four after starting the antimicrobial regimen. Clinical success will be considered when the fever resolves between day 1 and day 3 of starting antibiotics. **Measure:** Clinical response measured through fever resolution **Time Frame:** Day 4 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All patients \>18 years old * Diagnosis of any hematological malignancy * Severe neutropenia (polymorphonuclear \<500 cells/mm3) * Fever (≥38.3 degrees Celsius in one measure, or ≥38 degrees Celsius in at least two measures) * Median arterial pressure ≥65 mmHg on admission * A life expectancy ≥ 5 days * Agree to participate in the study Exclusion Criteria: * Known hypersensitivity to cephalosporins or anaphylaxis with beta-lactams * Clinical signs related to hemodynamic instability * Concomitant use of another antibiotic with activity against Gram-negatives (except Trimethoprim/Sulfamethoxazole (TMP/SMX) as prophylaxis for P. jirovecii * Patients with end-stage chronic renal failure (\<10 ml/min by creatinine clearance-ACCr) or on renal replacement therapy. * Patients with grade IV mucositis **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Diana Vilar Compte, M.D.,M.Sc. **Phone:** +52 5628 0400 **Phone Ext:** 12110 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Patricia Volkow, M.D. **Phone:** +52 5628 0400 **Phone Ext:** 12120 **Role:** CONTACT #### Locations **Location 1:** **City:** Mexico City **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Diana Vilar Compte, M.D., M.Sc. - **Phone:** +52 56280400 - **Phone Ext:** 12110 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Patricia Volkow, M.D. - **Phone:** +52 56280400 - **Phone Ext:** 12120 - **Role:** CONTACT ***Contact 3:*** - **Name:** Beda D Islas-Muñoz, M.D., M.Sc - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Pamela Alatorre-Fernández, M.D. - **Role:** SUB_INVESTIGATOR **Country:** Mexico **Facility:** Instituto Nacional de Cancerologia **State:** Tlalpan **Status:** RECRUITING **Zip:** 14080 #### Overall Officials **Official 1:** **Affiliation:** Instituto Nacional de Cancerología, Mexico **Name:** Patricia Cornejo-Juarez, M.D.,M.Sc. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** The data requisition must be carried out with a solid foundation for which the information will be used. The investigators and sub-investigators will review the criteria. **Description:** Individual participant data (IPD) could be shared with other researchers. **Info Types:** - STUDY_PROTOCOL - ICF **IPD Sharing:** YES **Time Frame:** The data will become available at the end of the study. The plan is to finish the analysis and write the manuscript at the end of 2025. ### References Module #### References **Citation:** Karaiskos I, Giamarellou H. Carbapenem-Sparing Strategies for ESBL Producers: When and How. Antibiotics (Basel). 2020 Feb 5;9(2):61. doi: 10.3390/antibiotics9020061. **PMID:** 32033322 **Citation:** Xie O, Cisera K, Taylor L, Hughes C, Rogers B. Clinical syndromes and treatment location predict utility of carbapenem sparing therapies in ceftriaxone-non-susceptible Escherichia coli bloodstream infection. Ann Clin Microbiol Antimicrob. 2020 Nov 30;19(1):57. doi: 10.1186/s12941-020-00400-z. **PMID:** 33256752 **Citation:** Giacobbe DR, Bassetti M, De Rosa FG, Del Bono V, Grossi PA, Menichetti F, Pea F, Rossolini GM, Tumbarello M, Viale P, Viscoli C; ISGRI-SITA (Italian Study Group on Resistant Infections of the Societa Italiana Terapia Antinfettiva). Ceftolozane/tazobactam: place in therapy. Expert Rev Anti Infect Ther. 2018 Apr;16(4):307-320. doi: 10.1080/14787210.2018.1447381. Epub 2018 Mar 9. **PMID:** 29493397 **Citation:** Shortridge D, Pfaller MA, Castanheira M, Flamm RK. Antimicrobial Activity of Ceftolozane-Tazobactam Tested Against Enterobacteriaceae and Pseudomonas aeruginosa with Various Resistance Patterns Isolated in U.S. Hospitals (2013-2016) as Part of the Surveillance Program: Program to Assess Ceftolozane-Tazobactam Susceptibility. Microb Drug Resist. 2018 Jun;24(5):563-577. doi: 10.1089/mdr.2017.0266. Epub 2017 Oct 17. **PMID:** 29039729 **Citation:** Pfaller MA, Bassetti M, Duncan LR, Castanheira M. Ceftolozane/tazobactam activity against drug-resistant Enterobacteriaceae and Pseudomonas aeruginosa causing urinary tract and intraabdominal infections in Europe: report from an antimicrobial surveillance programme (2012-15). J Antimicrob Chemother. 2017 May 1;72(5):1386-1395. doi: 10.1093/jac/dkx009. **PMID:** 28165526 **Citation:** Livermore DM, Mushtaq S, Meunier D, Hopkins KL, Hill R, Adkin R, Chaudhry A, Pike R, Staves P, Woodford N; BSAC Resistance Surveillance Standing Committee. Activity of ceftolozane/tazobactam against surveillance and 'problem' Enterobacteriaceae, Pseudomonas aeruginosa and non-fermenters from the British Isles. J Antimicrob Chemother. 2017 Aug 1;72(8):2278-2289. doi: 10.1093/jac/dkx136. **PMID:** 28520867 **Citation:** Pfaller MA, Shortridge D, Sader HS, Flamm RK, Castanheira M. Ceftolozane-tazobactam activity against drug-resistant Enterobacteriaceae and Pseudomonas aeruginosa causing healthcare-associated infections in Australia and New Zealand: Report from an Antimicrobial Surveillance Program (2013-2015). J Glob Antimicrob Resist. 2017 Sep;10:186-194. doi: 10.1016/j.jgar.2017.05.025. Epub 2017 Jul 19. **PMID:** 28735046 **Citation:** Pfaller MA, Shortridge D, Sader HS, Gales A, Castanheira M, Flamm RK. Ceftolozane-tazobactam activity against drug-resistant Enterobacteriaceae and Pseudomonas aeruginosa causing healthcare-associated infections in Latin America: report from an antimicrobial surveillance program (2013-2015). Braz J Infect Dis. 2017 Nov-Dec;21(6):627-637. doi: 10.1016/j.bjid.2017.06.008. Epub 2017 Sep 21. **PMID:** 28941394 **Citation:** Seifert H, Korber-Irrgang B, Kresken M; German Ceftolozane/Tazobactam Study Group. In-vitro activity of ceftolozane/tazobactam against Pseudomonas aeruginosa and Enterobacteriaceae isolates recovered from hospitalized patients in Germany. Int J Antimicrob Agents. 2018 Feb;51(2):227-234. doi: 10.1016/j.ijantimicag.2017.06.024. Epub 2017 Jul 10. **PMID:** 28705666 **Citation:** Fernandez-Cruz A, Alba N, Semiglia-Chong MA, Padilla B, Rodriguez-Macias G, Kwon M, Cercenado E, Chamorro-de-Vega E, Machado M, Perez-Lago L, Garcia de Viedma D, Diez Martin JL, Munoz P. A Case-Control Study of Real-Life Experience with Ceftolozane-Tazobactam in Patients with Hematologic Malignancy and Pseudomonas aeruginosa Infection. Antimicrob Agents Chemother. 2019 Jan 29;63(2):e02340-18. doi: 10.1128/AAC.02340-18. Print 2019 Feb. **PMID:** 30530598 **Citation:** Bergas A, Albasanz-Puig A, Fernandez-Cruz A, Machado M, Novo A, van Duin D, Garcia-Vidal C, Hakki M, Ruiz-Camps I, Del Pozo JL, Oltolini C, DeVoe C, Drgona L, Gasch O, Mikulska M, Martin-Davila P, Peghin M, Vazquez L, Laporte-Amargos J, Dura-Miralles X, Pallares N, Gonzalez-Barca E, Alvarez-Uria A, Puerta-Alcalde P, Aguilar-Company J, Carmona-Torre F, Clerici TD, Doernberg SB, Petrikova L, Capilla S, Magnasco L, Fortun J, Castaldo N, Carratala J, Gudiol C. Real-Life Use of Ceftolozane/Tazobactam for the Treatment of Bloodstream Infection Due to Pseudomonas aeruginosa in Neutropenic Hematologic Patients: a Matched Control Study (ZENITH Study). Microbiol Spectr. 2022 Jun 29;10(3):e0229221. doi: 10.1128/spectrum.02292-21. Epub 2022 Apr 27. **PMID:** 35475683 **Citation:** Criscuolo M, Trecarichi EM. Ceftazidime/Avibactam and Ceftolozane/Tazobactam for Multidrug-Resistant Gram Negatives in Patients with Hematological Malignancies: Current Experiences. Antibiotics (Basel). 2020 Feb 3;9(2):58. doi: 10.3390/antibiotics9020058. **PMID:** 32028615 **Citation:** Marchesi F, Toma L, Di Domenico EG, Cavallo I, Spadea A, Prignano G, Pimpinelli F, Papa E, Terrenato I, Ensoli F, Mengarelli A. Ceftolozane-Tazobactam for Febrile Neutropenia Treatment in Hematologic Malignancy Patients Colonized by Multi-Resistant Enterobacteriaceae: Preliminary Results from a Prospective Cohort Study. Mediterr J Hematol Infect Dis. 2020 Sep 1;12(1):e2020065. doi: 10.4084/MJHID.2020.065. eCollection 2020. No abstract available. **PMID:** 32952976 **Citation:** Clerici D, Oltolini C, Greco R, Ripa M, Giglio F, Mastaglio S, Lorentino F, Pavesi F, Farina F, Liberatore C, Castiglion B, Tassan Din C, Bernardi M, Corti C, Peccatori J, Scarpellini P, Ciceri F, Castagna A. The place of ceftazidime/avibactam and ceftolozane/tazobactam for therapy of haematological patients with febrile neutropenia. Int J Antimicrob Agents. 2021 Jun;57(6):106335. doi: 10.1016/j.ijantimicag.2021.106335. Epub 2021 Apr 7. **PMID:** 33838223 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009369 - Term: Neoplasms - ID: D000000380 - Term: Agranulocytosis - ID: D000007970 - Term: Leukopenia - ID: D000095542 - Term: Cytopenia - ID: D000006402 - Term: Hematologic Diseases - ID: D000007960 - Term: Leukocyte Disorders - ID: D000001424 - Term: Bacterial Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000007239 - Term: Infections - ID: D000018805 - Term: Sepsis - ID: D000018746 - Term: Systemic Inflammatory Response Syndrome - ID: D000007249 - Term: Inflammation - ID: D000010335 - Term: Pathologic Processes - ID: D000009371 - Term: Neoplasms by Site ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M2454 - Name: Hyperthermia - Relevance: LOW - As Found: Unknown - ID: M8464 - Name: Fever - Relevance: LOW - As Found: Unknown - ID: M14409 - Name: Pseudomonas Infections - Relevance: LOW - As Found: Unknown - ID: M21314 - Name: Hematologic Neoplasms - Relevance: HIGH - As Found: Hematologic Neoplasms - ID: M18877 - Name: Bacteremia - Relevance: HIGH - As Found: Bacteremia - ID: M12443 - Name: Neutropenia - Relevance: HIGH - As Found: Neutropenia - ID: M3730 - Name: Agranulocytosis - Relevance: LOW - As Found: Unknown - ID: M10973 - Name: Leukopenia - Relevance: LOW - As Found: Unknown - ID: M3170 - Name: Cytopenia - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M10963 - Name: Leukocyte Disorders - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown - ID: M20864 - Name: Sepsis - Relevance: LOW - As Found: Unknown - ID: M16869 - Name: Toxemia - Relevance: LOW - As Found: Unknown - ID: M20818 - Name: Systemic Inflammatory Response Syndrome - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown - ID: T2606 - Name: Granulocytopenia - Relevance: HIGH - As Found: Neutropenia ### Condition Browse Module - Meshes - ID: D000016470 - Term: Bacteremia - ID: D000019337 - Term: Hematologic Neoplasms - ID: D000009503 - Term: Neutropenia ### Intervention Browse Module - Ancestors - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000065093 - Term: beta-Lactamase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000892 - Term: Anti-Infective Agents, Urinary ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M1938 - Name: Tazobactam - Relevance: HIGH - As Found: Tocilizumab - ID: M13772 - Name: Piperacillin - Relevance: HIGH - As Found: Prompt - ID: M261814 - Name: Ceftolozane - Relevance: HIGH - As Found: Squamous Cell Cancer - ID: M255449 - Name: Ceftolozane, tazobactam drug combination - Relevance: HIGH - As Found: Aftercare - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M5692 - Name: Ceftazidime - Relevance: LOW - As Found: Unknown - ID: M5760 - Name: Cephalosporins - Relevance: LOW - As Found: Unknown - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M30450 - Name: beta-Lactamase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M1885 - Name: Piperacillin, Tazobactam Drug Combination - Relevance: HIGH - As Found: Monocyte - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000078142 - Term: Tazobactam - ID: D000010878 - Term: Piperacillin - ID: D000077725 - Term: Piperacillin, Tazobactam Drug Combination - ID: C000519491 - Term: Ceftolozane - ID: C000594038 - Term: Ceftolozane, tazobactam drug combination ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422520 **Brief Title:** Phase 1 First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors **Official Title:** A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BGB-C354, an Antibody-Drug Conjugate Targeting B7H3, Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors #### Organization Study ID Info **ID:** BGB-C354-101 #### Organization **Class:** INDUSTRY **Full Name:** BeiGene #### Secondary ID Infos **ID:** 2024-513280-11-00 **Type:** CTIS ### Status Module #### Completion Date **Date:** 2026-11-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-11-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-24 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** BeiGene #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a first-in-human, Phase 1a/1b study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BGB-C354 alone and in combination with tislelizumab in participants with advanced solid tumors. Study details include: * The study will be conducted in 2 phases: Phase 1a (Monotherapy Dose Escalation and Safety Expansion) and Phase 1b (Dose Expansion). * The visit frequency will be approximately every 21 days during study treatment, and higher frequencies may be considered based on emerging data. The maximum treatment duration will be up to 2 years. * The study duration is estimated to be approximately 5 years. ### Conditions Module **Conditions:** - Advanced Solid Tumor **Keywords:** - BGB-C354 - Tislelizumab - First-in-human - Advanced solid tumor - Anti-PD-1 Monoclonal Antibody - B7H3 - antibody drug conjugate ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 62 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** BGB-C354 monotherapy doses at sequentially increasing levels. **Intervention Names:** - Drug: BGB-C354 **Label:** Phase 1a: Part A (Monotherapy Dose Escalation) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will enroll at safe dose levels recommended by the Safety Monitoring Committee (SMC) for further evaluation. **Intervention Names:** - Drug: BGB-C354 **Label:** Phase 1a: Part B (Safety Expansion) **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** The dose expansion phase begins after determining the recommended dose for expansion (RDFE) and schedule from Phase 1a, exploring at least 2 dose levels for optimization. **Intervention Names:** - Drug: BGB-C354 **Label:** Phase 1b: Part C (Monotherapy Expansion) **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** BGB-C354 and tislelizumab will start at the RDFE-1 level set by the SMC using Phase 1a data, or at a dose level lower than the highest tolerable level established in Part A. **Intervention Names:** - Drug: BGB-C354 - Drug: Tislelizumab **Label:** Phase 1b: Part D (Combination Therapy Expansion) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Phase 1a: Part A (Monotherapy Dose Escalation) - Phase 1a: Part B (Safety Expansion) - Phase 1b: Part C (Monotherapy Expansion) - Phase 1b: Part D (Combination Therapy Expansion) **Description:** Administered by intravenous infusion **Name:** BGB-C354 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Phase 1b: Part D (Combination Therapy Expansion) **Description:** Administered by intravenous infusion **Name:** Tislelizumab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Number of participants with AEs and SAEs characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 \[NCI-CTCAE v 5.0\]), timing, seriousness, and relationship to study drug(s); physical examinations; electrocardiograms (ECGs); and laboratory assessments as needed; and adverse events meeting protocol-defined dose-limitingtoxicity (DLT) criteria **Measure:** Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) **Time Frame:** Up to approximately 2 years **Description:** Defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30% or the highest dose administered, respectively **Measure:** Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-C354 **Time Frame:** Up to approximately 2 years **Description:** The potential RDFE(s) of BGB-C354 will be determined based on the MTD or MAD, taking into consideration the long-term tolerability, pharmacokinetics (PK), preliminary antitumor activity, and any other relevant data, as available **Measure:** Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-C354 **Time Frame:** Up to approximately 2 years **Description:** ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1). **Measure:** Phase 1b: Overall Response Rate (ORR) **Time Frame:** Up to approximately 2 years **Description:** The RP2D of BGB-C354 will be determined based on safety, PK, pharmacodynamics, preliminary antitumor activity, and other relevant data, as available. **Measure:** Phase 1b: Recommended Phase 2 dose (RP2D) of BGB-C354 alone and in combination with tislelizumab **Time Frame:** Up to approximately 2 years #### Secondary Outcomes **Description:** ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1. **Measure:** Phase 1a: ORR **Time Frame:** Up to approximately 2 years **Description:** DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator. **Measure:** Duration of Response (DOR) **Time Frame:** Up to approximately 2 years **Description:** DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease as determined from tumor assessments by the investigator using RECIST v1.1. **Measure:** Disease Control Rate (DCR) **Time Frame:** Up to approximately 2 years **Description:** PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first.determined from tumor assessments by the investigator using RECIST v1.1. **Measure:** Phase 1b: Progression Free Survival (PFS) **Time Frame:** Up to approximately 2 years **Description:** Number of participants with AEs and SAEs characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 \[NCI-CTCAE v 5.0\]), timing, seriousness, and relationship to study drug(s); physical examinations; electrocardiograms (ECGs); and laboratory assessments as needed; and adverse events meeting protocol-defined dose-limitingtoxicity (DLT) criteria **Measure:** Phase 1b: Number of Participants with Adverse Events (AEs) and Serious Adverse Events **Time Frame:** Up to approximately 2 years **Measure:** Maximum observed plasma concentration (Cmax) for BGB-C354 **Time Frame:** Up to approximately 2 years **Measure:** Minimum observed plasma concentration (Cmin) for BGB-C354 **Time Frame:** Up to approximately 2 years **Measure:** Time to maximum plasma concentration (Tmax) for BGB-C354 **Time Frame:** Up to approximately 2 years **Measure:** Half-life (t1/2) for BGB-C354 **Time Frame:** Up to approximately 2 years **Measure:** Area under the concentration-time curve (AUC) for BGB-C354 **Time Frame:** Up to approximately 2 years **Measure:** Apparent clearance (CL/F) for BGB-C354 **Time Frame:** Up to approximately 2 years **Measure:** Apparent volume of distribution (Vz/F) for BGB-C354 **Time Frame:** Up to approximately 2 years **Measure:** Accumulation ratio for BGB-C354 **Time Frame:** Up to approximately 2 years **Measure:** Number of participants with anti-drug antibodies (ADAs) to BGB-C354 **Time Frame:** Up to approximately 2 years **Measure:** Serum concentration of BGB-C354 **Time Frame:** Up to approximately 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 3. Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, whose cancer is not amenable to therapy with curative intent: 4. ≥ 1 measurable lesion per RECIST v1.1. 5. Able to provide an archived tumor tissue sample. 6. Adequate organ function. 7. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 7 months after the last dose of study drug(s). 8. Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 4 months after the last dose of study drug(s). Exclusion Criteria: 1. Prior treatment with B7H3-targeted therapy. 2. For Part B and Phase 1b: Prior treatment with antibody drug conjugates (ADCs) with topoisomerase I inhibitor payload (for Phase 1b, unless otherwise specified for specific cohorts). 3. Participants with spinal cord compressions, active leptomeningeal disease or uncontrolled, or untreated brain metastasis 4. Any malignancy ≤ 2 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast). 5. History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygen saturation at rest \< 92%, or requirement for supplemental oxygen at baseline 6. Uncontrolled diabetes, or \> Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium levels despite standard medical management ≤ 14 days before the first dose of study drug(s). 7. Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s). Note: Other protocol defined Inclusion/Exclusion criteria may apply. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Study Director **Phone:** 1.877.828.5568 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** BeiGene **Name:** Study Director **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents ### Intervention Browse Module - Browse Leaves - ID: M4230 - Name: Antibodies, Monoclonal - Relevance: LOW - As Found: Unknown - ID: M137899 - Name: Tislelizumab - Relevance: HIGH - As Found: Intensive Care - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000707970 - Term: Tislelizumab ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422507 **Acronym:** PHOTONiC **Brief Title:** A Study to Learn More About How Well 8 Milligram Aflibercept Works and How Safe it is in Chinese Participants With Diabetic Macular Edema **Official Title:** Multi-Center, Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of 8 mg Aflibercept in Chinese Participants With Diabetic Macular Edema #### Organization Study ID Info **ID:** 21583 #### Organization **Class:** INDUSTRY **Full Name:** Bayer ### Status Module #### Completion Date **Date:** 2026-05-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-23 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Regeneron Pharmaceuticals #### Lead Sponsor **Class:** INDUSTRY **Name:** Bayer #### 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:** Researchers are looking for a better way to treat people who have diabetic macular edema. Diabetic macular edema (DME) is a diabetes-related eye disorder. In DME, the macula, which is the central part of the retina at the back of the eye, swells up resulting in vision problems. This happens due to leakage of fluid from damaged blood vessels. The study treatment, 8 milligram (mg) aflibercept is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth and leakage of blood vessels at the back of the eye. A lower dose of aflibercept (2 mg) is already approved for the treatment of DME. Based on the findings of another study, the higher dose of aflibercept (8 mg) is expected to reduce the frequency of injections required for treating DME while being equally safe and working as well as the lower dose. The higher dose could make it easier to treat DME and improve quality of life for people with DME. The main purpose of this study is to learn if high-dose (8 mg) aflibercept given every 16 weeks works as well as low-dose (2 mg) aflibercept given every 8 weeks in Chinese participants. For this, the researchers will compare the change in participants' 'best corrected visual acuity' (BCVA) after 48 weeks of starting the treatment. BCVA is the clearest vision a participant can have with the help of corrective lenses, such as glasses. It will be measured by the number of letters the participant can read on an eye chart. This is known as their Early Treatment Diabetic Retinopathy Study (ETDRS) letter score. Participants will be randomly (by chance) assigned to one of two treatment groups to receive study treatment as an injection into the eye up to Week 56: * 2 mg aflibercept every 8 weeks after receiving 5 initial monthly doses * 8 mg aflibercept every 16 weeks after receiving 3 initial monthly doses Each participant will be in the study for around 63 weeks with up to 18 visits to the study site. This includes: * one visit up to 21 days before the treatment starts during which the doctors will confirm that the participant can take part in the study * 16 visits during which the treatment will be given. Most of these visits will have a gap of 4 weeks except for one visit that will happen a few days after the previous visit * one visit 4 weeks after the treatment ends During the study, the doctors and their study team will: * check the participants' vision and their overall eye health using different eye tests * check participants' health by performing tests such as blood and urine tests * ask the participants questions about the disease and study treatment and how these impact their quality of life * ask the participants what adverse events they are having An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think they are related to the study treatment. Access to study treatment after the end of this study is not planned. Participants can switch to available approved treatments for DME. **Detailed Description:** EYLEA (aflibercept 40 mg/mL solution for injection) at a dosage level of 2 mg administered intravitreally (IVT) is approved in over 100 countries for the treatment of DME. Despite the proven efficacy and safety of EYLEA in patients with DME, there remains an unmet need for alternative therapies that can decrease the burden of DME treatment via a reduction in the required frequency of IVT injections, while improving visual and anatomic outcomes. The overall one and two year results of PHOTON, a global phase 2/3 trial evaluating high dose (HD or 8 mg) aflibercept in participants with center-involved diabetic macular edema (DME), demonstrate the benefit of HD aflibercept for reducing the frequency of injections required for the treatment of DME while providing visual and anatomic outcomes non-inferior to and a safety profile indistinguishable from EYLEA, 2 mg aflibercept, the established standard of care for the treatment of DME. The observed reduction in the number of HD aflibercept injections required for the treatment of DME over 2 years in PHOTON is expected to translate into the benefit of reducing the burden of treatment and, thereby improving the quality of life for DME patients, their caregivers and health care providers. This study aims to investigate the efficacy and safety of HD aflibercept in Chinese participants with DME over 60 weeks with the primary objective of achieving non-inferior best corrected visual acuity (BCVA) with an extended dosing interval (every 16 weeks after 3 initial monthly injections) vs. 2 mg aflibercept (every 8 weeks after 5 initial monthly injections) similar to the results obtained in PHOTON. This study is designed to support the registration of HD aflibercept for the treatment of DME in China. Primary Objective: The primary objective of the study is to determine if treatment with HD aflibercept at intervals of 16 weeks provides non-inferior best-corrected visual acuity (BCVA) compared to 2 mg aflibercept dosed every 8 weeks in Chinese participants Secondary Objectives: * To determine the effect of HD aflibercept vs. 2 mg aflibercept on anatomic and other visual measures of response; * To evaluate the safety, immunogenicity and pharmacokinetics (PK) of HD aflibercept in Chinese participants. Primary endpoint: * Change from baseline in BCVA by ETDRS letter score at Week 48 Secondary endpoints: * Change from baseline in BCVA by ETDRS letter score at Week 60 * Participants gaining ≥15 letters at Week 48 and Week 60 * Participants achieving an ETDRS letter score of at least 69 (approximate 20/40 Snellen equivalent) at Week 48 * Participants with no IRF and/or no SRF in the center subfield at Week 48 * Change from baseline in central subfield thickness (CST) at Week 48 * Change from baseline in leakage on fluorescein angiography (FA) at Week 48 * Change from baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ) total score at Week 48 * Occurrence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Weeks 48 and 60 * Participants developing a treatment-emergent ADA response or Nabs to aflibercept through EOS at Week 60 * Systemic exposure to aflibercept as assessed by plasma concentrations of free, adjusted bound, and total aflibercept from baseline through Week 48 This study is a phase 3, multi-center, randomized, double-masked, active-controlled study in Chinese participants with DME involving the center of the macula to investigate the efficacy and safety of HD aflibercept versus 2 mg aflibercept. The primary objective of the study is to determine if treatment with HD aflibercept at 16 week intervals provides non-inferior BCVA compared to 2 mg aflibercept dosed every 8 weeks in Chinese participants. 322 eligible participants randomized in a 1:1 ratio to the following 2 treatment groups: 1. 2q8: 2 mg aflibercept every 8 weeks following 5 initial monthly doses (n=161) and 2. HDq16: HD aflibercept every 16 weeks following 3 initial monthly doses (n=161). The study consists of a screening period, a treatment period, and an end of study (EOS) visit at Week 60. The study duration for a participant is approximately 63 weeks. The EOS is defined as the last visit of the last participant. No study treatment will be administered at the EOS visit at Week 60. HD aflibercept is the sponsor's study intervention under investigation. The following intervention groups are included in the study: * 2 mg aflibercept every 8 weeks (2q8) * 8 mg aflibercept every 16 weeks (HDq16) ### Conditions Module **Conditions:** - Diabetic Macular Edema **Keywords:** - DME ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The study duration for a participant is approx 63 weeks. EOS is defined as the last visit of the last participant. HD aflibercept is the sponsor's study intervention under investigation. 322 participants will be randomized into 2 treatment groups in a ratio of 1:1 to receive either 2 mg aflibercept every 8 weeks following 5 initial monthly doses (2q8) or HD aflibercept (8mg) every 16 weeks following 3 initial monthly doses (HDq16). Randomization will be stratified according to baseline Central subfield thickness (CST \<400µm, ≥400µm), baseline BCVA (\<60 vs ≥60 ETDRS letters) and prior treatment for DME. Only 1 eye per participant is identified as the study eye. If a participant's fellow (non-study) eye has DME or Neovascular age-related macular degeneration (nAMD) that requires anti-Vascular endothelial growth factor (VEGF) treatment during the participant's involvement in the study, this eye should be treated with EYLEA (2mg aflibercept) and won't be considered an additional study eye. ##### Masking Info **Masking:** DOUBLE **Masking Description:** The study will be conducted in double-masked fashion. Study participants and masked study site personnel will remain masked to all randomization assignments throughout the study. The Sponsor personnel who are in regular contact with the study site will remain masked to all participant randomization assignments. The operational conduct of the study after the primary analysis at Week 48 will be maintained by a masked team. No decisions on data will be taken by any of the unmasked study personnel. To preserve masking, sham injections will be performed for all participants at treatment visits in which participants do not receive an active injection through Week 56. **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 322 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants that will be enrolled to this treatment arm will receive 2 mg aflibercept every 8 weeks following 5 initial monthly doses starting at Baseline (visit 2) (2q8) for the chosen "study eye". Randomization will be stratified according to baseline Central subfield thickness (CST) (\<400 µm, ≥400 µm), baseline Best corrected visual acuity (BCVA) (\<60 vs. ≥60 ETDRS letters) and prior treatment for DME. **Intervention Names:** - Drug: 2 mg aflibercept (EYLEA, BAY 86-5321) - Other: Sham **Label:** 2 mg aflibercept **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Participants that will be enrolled to this treatment arm will receive 8 mg (high dose - HD) aflibercept every 16 weeks following 3 initial monthly doses, starting at Baseline (Visit 2) (HDq16) for the chosen "study eye". Randomization will be stratified according to baseline Central subfield thickness (CST) (\<400 µm, ≥400 µm), baseline Best corrected visual acuity (BCVA) (\<60 vs. ≥60 ETDRS letters) and prior treatment for DME. **Intervention Names:** - Drug: 8 mg aflibercept (BAY 86-5321) (High Dose) - Other: Sham **Label:** 8 mg aflibercept (high dose) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 8 mg aflibercept (high dose) **Description:** High-dose (HD) aflibercept is the sponsor's study intervention under investigation. Dose formulation: solution in vial. Unit dose strength: 114.3 mg/mL, Dosage Level: 8 mg (70 µL), Route of Administration: Intravitreal (IVT) injection every 16 weeks following 3 initial monthly doses. Packaging/ Labeling: Study Intervention will be provided in sterile 3 mL glass vials. Each vial will be labeled as required per country requirement. **Name:** 8 mg aflibercept (BAY 86-5321) (High Dose) **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - 2 mg aflibercept **Description:** Aflibercept 2 mg is the sponsor's active comparator. Dose formulation: solution in vial. Unit dose strength: 40 mg/mL, Dosage Level: 2 mg (50 µL), Route of Administration: Intravitreal (IVT) injection every 8 weeks following 5 initial monthly doses. Packaging/ Labeling: Study Intervention will be provided in sterile 2 mL glass vials. Each vial will be labeled as required per country requirement. Aflibercept 2 mg for the non-study "fellow eye" treatment is considered an auxiliary medicinal product (AxMP) in this study. Fellow eye treatment will be allowed with 2 mg aflibercept, at the investigator's discretion for indications approved by governing authorities. The treated fellow eye will not be considered an additional study eye. **Name:** 2 mg aflibercept (EYLEA, BAY 86-5321) **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - 2 mg aflibercept - 8 mg aflibercept (high dose) **Description:** To preserve masking, sham injections will be performed for all participants at treatment visits in which participants do not receive an active injection through Week 56. Sham kits will be assigned for visits requiring sham injections. The sham kits are empty but should be handled in the same way as the active study intervention kits. Sham injections will be given on visits when an active injection is not planned. During the study treatment period all participants will receive either an active injection (8 mg or 2 mg aflibercept) or a sham injection (for masking purposes) following their assigned treatment group and eligibility for Dose regimen modification (DRM). **Name:** Sham **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The primary endpoint is the change from baseline in BCVA at Week 48. Efficacy analyses will be conducted using the Full analysis set (FAS). The primary efficacy analysis will be a comparison between 2 comparative arms: HDq16 vs. 2q8. The primary efficacy variable (Change from baseline in BCVA by ETDRS letter score at Week 48) will be analyzed using FAS with an Mixed Model for Repeated Measurements (MMRM) analysis model. The model includes baseline BCVA as a covariate, treatment group, baseline CST category, baseline BCVA category, prior DME treatment, and visit as fixed effects, and interaction terms for treatment by visit and baseline BCVA by visit. A Kenward-Roger approximation will be used for the denominator degrees of freedom. **Measure:** Change from baseline in Best corrected visual acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score at Week 48 **Time Frame:** Week 0 (Baseline) to Week 48 #### Secondary Outcomes **Measure:** Change from baseline in BCVA by ETDRS letter score at Week 60 **Time Frame:** Week 0 (Baseline) to Week 60 **Measure:** Participants gaining ≥15 letters at Week 48 and Week 60 **Time Frame:** Week 48 and Week 60 **Measure:** Participants achieving an ETDRS letter score of at least 69 (approximate 20/40 Snellen equivalent) at Week 48 **Time Frame:** Week 48 **Measure:** Participants with no Intraretinal fluid (IRF) and/or no Subretinal fluid (SRF) in the center subfield at Week 48 **Time Frame:** Week 48 **Measure:** Change from baseline in central subfield thickness (CST) at Week 48 **Time Frame:** Week 0 (Baseline) to Week 48 **Measure:** Change from baseline in leakage on fluorescein angiography (FA) at Week 48 **Time Frame:** Week 0 (Baseline) to Week 48 **Measure:** Change from baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ) total score at Week 48 **Time Frame:** Week 0 (Baseline) to Week 48 **Measure:** Occurrence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Weeks 48 and 60 **Time Frame:** Week 48 to Week 60 **Measure:** Participants developing a treatment-emergent Anti-drug antibody (ADA) response or Nabs to aflibercept through EOS at Week 60 **Time Frame:** Week 60 **Measure:** Systemic exposure to aflibercept as assessed by plasma concentrations of free, adjusted bound, and total aflibercept from baseline through Week 48 **Time Frame:** Week 0 (Baseline) to Week 48 ### Eligibility Module **Eligibility Criteria:** Key Inclusion Criteria: * Men or women ≥18 years of age * Chinese participants with type 1 or type 2 diabetes mellitus and diabetic macular edema (DME) with central involvement defined as CST ≥300 µm (or ≥320 µm on Heidelberg Spectralis) in the study eye as determined by the reading center at the screening visit and confirmed by the site at baseline visit * BCVA early treatment diabetic retinopathy study (ETDRS) letter score of 78 to 24 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye at the screening and baseline visits with decreased vision determined to be primarily the result of DME * Women of childbearing potential (WOCBP) or men who are sexually active with partners of childbearing potential must agree to use highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 4 months after the last administration of study intervention. Key Exclusion Criteria: * Evidence of macular edema due to any cause other than diabetes mellitus in either eye * Active proliferative diabetic retinopathy in the study eye * Panretinal laser photocoagulation (PRP) or macular laser photocoagulation in the study eye within 12 weeks (84 days) of the screening visit * IVT anti-VEGF treatment (aflibercept, ranibizumab, bevacizumab, conbercept, faricimab, brolucizumab, pegaptanib sodium) in the study eye within 12 weeks (84 days) of the screening visit * Previous use of topical steroids within 4 weeks (28 days) of the screening visit or of intraocular or periocular corticosteroids in the study eye within 16 weeks (112 days) of the screening visit, or ILUVIEN or OZURDEX IVT implants at any time * Prior ocular investigational agents (that have not been approved) in either eye (e.g., IVT, suprachoroidal injections, ocular implants, etc.) at any time. * Previous treatment with an investigational or approved intraocular gene therapy or cell therapy in either eye at any time. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Bayer Clinical Trials Contact **Phone:** (+)1-888-84 22937 **Role:** CONTACT ### IPD Sharing Statement Module **Description:** Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008268 - Term: Macular Degeneration - ID: D000012162 - Term: Retinal Degeneration - ID: D000012164 - Term: Retinal Diseases - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M11261 - Name: Macular Edema - Relevance: HIGH - As Found: Macular Edema - ID: M7657 - Name: Edema - Relevance: HIGH - As Found: Edema - ID: M11260 - Name: Macular Degeneration - Relevance: LOW - As Found: Unknown - ID: M14997 - Name: Retinal Degeneration - Relevance: LOW - As Found: Unknown - ID: M14999 - Name: Retinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008269 - Term: Macular Edema - ID: D000004487 - Term: Edema ### Intervention Browse Module - Ancestors - ID: D000020533 - Term: Angiogenesis Inhibitors - ID: D000043924 - Term: Angiogenesis Modulating Agents - ID: D000006133 - Term: Growth Substances - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000006131 - Term: Growth Inhibitors - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M257727 - Name: Aflibercept - Relevance: HIGH - As Found: Pregnant - ID: M22318 - Name: Angiogenesis Inhibitors - Relevance: LOW - As Found: Unknown - ID: M9231 - Name: Growth Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000533178 - Term: Aflibercept ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422494 **Acronym:** RAID-II **Brief Title:** The Role of the Adrenergic System in Hypoglycaemia Induced Inflammatory Response in People With Type 1 Diabetes and People Without Type 1 Diabetes-RAID-II **Official Title:** The Role of the Adrenergic System in Hypoglycaemia Induced Inflammatory Response in People With Type 1 Diabetes and People Without Type 1 Diabetes-RAID-II #### Organization Study ID Info **ID:** 115142 #### Organization **Class:** OTHER **Full Name:** Radboud University Medical Center ### Status Module #### Completion Date **Date:** 2025-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **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:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Radboud University Medical Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this trial is to study the effect that adrenaline has on the immune reaction seen during a low blood sugar. People with type 1 diabetes do not produce their own insulin. The cells in the pancreas that produce insulin are destroyed. People with type 1 diabetes require daily insulin administration. As a consequence of this insulin therapy the blood sugar can dip too low, causing symptoms such as confusion, irritation and tiredness. This is called hypoglycaemia. Hypoglycaemia has been associated with an increased risk for cardiovascular disease such as heart attacks. During hypoglycaemia the immune system is activated. The immune system consists of white blood cells which produce cytokines, these are proteins used to kill pathogens such as bacteria. During hypoglycaemia there are no pathogens but the cytokines are still produced, leading to unwanted damage. A previous study performed by our research group showed that the immune system activation caused by hypoglycaemia is associated with the stress hormone adrenaline. Adrenaline is released by the body in moments of stress such as during running or bungee jumping. Adrenaline is also released by the body during hypoglycaemia to increase the sugar level. Our hypothesis is that adrenaline activates the immune system during hypoglycaemia. Adrenaline acts in the body through two receivers, these are called alpha and beta receptors. These are present on almost all cells in the body especially on the immune cells. With the study we want to study the situation where there is a hypoglycaemia without the adrenaline. We will achieve this by lowering the blood sugar in participants. During the low blood sugar we will administer two drugs, which will attach themselves to the adrenaline receivers, the alpha and beta receptor. With this method we hope to block the adrenaline effects and with that block the immune response caused by adrenaline. **Detailed Description:** Rationale: Hypoglycaemia has shown to cause a sustained pro-inflammatory response which could promote a pro-atherogenic state and explain the association between hypoglycaemia and cardiovascular events. This pro-inflammatory response has been linked to the adrenaline response to hypoglycaemia. Adrenergic blockade with α and β adrenergic receptor antagonists (ARA) has shown to blunt the leukocyte response after hypoglycaemia induction and adrenaline administration. Whether and to what degree a combined blockade blunts the hypoglycaemia induced pro-inflammatory response is unknown. Objective: to examine the effect of adrenergic inhibition on the hypoglycaemia induced inflammatory response (e.g. leukocyte phenotype, cytokines, inflammatory proteins) by performing a hyperinsulinaemic hypoglycaemic glucose clamp alongside infusion of α-ARA and β-ARA. Secondary objectives consist of the effect of adrenergic blockade during hypoglycaemia on atherogenic parameters and glucose metrics ( e.g. time in range). Study design: Intervention study with a cross-over design Study population: Potentially eligible adult ( 16 - 75 years) participants will be recruited through social media, the Radboudumc outpatient clinic and other advertisements. We will recruit a total of 24 individuals, i.e. 12 healthy participants and 12 participants with type 1 diabetes. Participants with type 1 diabetes will be twice ( as there are two investigational days) equipped with a blinded continuous glucose monitoring device (CGM) during the test, which will measure interstitial glucose levels for a total of 10 days. Intervention: All participants will undergo a hyperinsulinaemic hypoglycaemic glucose clamp ( nadir 2.8 mmol/L). During the clamp the participants will be randomized to receive an infusion of saline or an infusion of phentolamine and propranolol. This will be done using a cross-over design. The participants will undergo both the saline and adrenergic blockade. Main study parameters/endpoints: The main study parameter will be the monocyte count after 60 minutes hyperinsulinaemic hypoglycaemic clamp and adrenergic blockade during the clamp. ### Conditions Module **Conditions:** - Diabetes Mellitus, Type 1 - Inflammation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** Potentially eligible adult ( 16 - 75 years) participants will be recruited through social media, the Radboudumc outpatient clinic and other advertisements. We will recruit a total of 24 individuals, i.e. 12 healthy participants and 12 participants with type 1 diabetes. Participants with type 1 diabetes will be twice ( as there are two investigational days) equipped with a blinded continuous glucose monitoring device (CGM) during the test, which will measure interstitial glucose levels for a total of 10 days. ##### Masking Info **Masking:** SINGLE **Masking Description:** Participants will be blinded tot the co-infusion during hypoglycaemia. This will be achieved by similar labelling, with phentolamine having the label infusion A and the propranolol infusion having the label infusion B. When administering saline the 50 milliliter syringes will be filled with saline instead of the solution containing either phentolamine or propranolol. Both saline syringes will still have the labels infusion A and infusion B. The investigators will not be blinded as they will be preparing the adrenergic solutions and the saline solutions. The participants will receive the same amount of millilitres during both infusions, determined by the amount infused during adrenergic blockade. Participants will be block-randomized with blocks of 2 using a randomisation list allocated to receive either the adrenergic blockade or the saline first. The coordinating investigator will have access to this list. **Who Masked:** - PARTICIPANT **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 24 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The participants without type 1 diabetes **Intervention Names:** - Drug: hyperinsulinaemic hypoglycaemic clamp - Drug: Propranolol Hydrochloride 1 MG/ML - Drug: Phentolamine **Label:** Participants without type 1 diabetes **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Participants with type 1 diabetes **Intervention Names:** - Drug: hyperinsulinaemic hypoglycaemic clamp - Drug: Propranolol Hydrochloride 1 MG/ML - Drug: Phentolamine **Label:** Participants with type 1 diabetes **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Participants with type 1 diabetes - Participants without type 1 diabetes **Description:** Insulin will be infused at a continuous rate of 60 mU∙m-2 ∙min-1 and glucose 20% will be infused at a variable rate, aiming for stable plasma glucose levels of 5.0 mmol/L. The infusion rate of glucose will be adjusted by plasma glucose levels, measured at 5-minute intervals. After 30 minutes of stable euglycaemia, plasma glucose levels will be allowed to drop gradually to 2.8 mmol/L and will be maintained at this level for 60 minutes. Then, insulin infusion and adrenergic blockade infusions will be stopped. Glucose infusion will be increased and then tapered until stable euglycaemia plasma levels are reached. **Name:** hyperinsulinaemic hypoglycaemic clamp **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Participants with type 1 diabetes - Participants without type 1 diabetes **Description:** When euglycaemic level of 5.0mmol/L is achieved we will start the adrenergic blockade which will continue throughout euglycaemia and hypoglycaemia. The participants will be administered a bolus of phentolamine of 70µg/kg followed by a dose of 7.0µg/kg/min continuous infusion and a bolus of propranolol of 14µg/kg followed by a dose of 1.4µg/kg/min. **Name:** Propranolol Hydrochloride 1 MG/ML **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Participants with type 1 diabetes - Participants without type 1 diabetes **Description:** When euglycaemic level of 5.0mmol/L is achieved we will start the adrenergic blockade which will continue throughout euglycaemia and hypoglycaemia. The participants will be administered a bolus of phentolamine of 70µg/kg followed by a dose of 7.0µg/kg/min continuous infusion and a bolus of propranolol of 14µg/kg followed by a dose of 1.4µg/kg/min. **Name:** Phentolamine **Type:** DRUG ### Outcomes Module #### Other Outcomes **Measure:** HbA1c expressed in mmol/L **Time Frame:** At screening **Measure:** Serum creatinine for kidney function expressed in umol/L **Time Frame:** Once at the screening at least 1 week before the hypoglycaemia **Description:** Measured by automatic sphygmomanometer **Measure:** Vitals ( blood pressure and heart rate) **Time Frame:** At both investigational days, every 15 minutes during each investigational day for a total of 8 hours. **Description:** Using length and weight expressed in kg/m\^2 **Measure:** Body mass index **Time Frame:** Once at the screening at least 1 week before the hypoglycaemia **Measure:** Age **Time Frame:** Once at the screening at least 1 week before the hypoglycaemia **Description:** Male or female **Measure:** Sex **Time Frame:** Once at the screening at least 1 week before the hypoglycaemia **Measure:** Duration of diabetes ( years) **Time Frame:** Once at the screening at least 1 week before the hypoglycaemia #### Primary Outcomes **Description:** The number of monocytes following 60 minutes hypoglycaemia and adrenergic blockade compared to baseline. Adrenergic blockade using Phentolamine and Propranolol intravenously. Expressed in 10\^3/µl measured using a sysmex machine. **Measure:** Monocyte count after 60 minutes of hypoglycaemia and adrenergic blockade **Time Frame:** After 60 minutes of hypoglycaemia and adrenergic blockade #### Secondary Outcomes **Description:** Leukocyte count at the time points 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia, +1 day, +3 days and 1 week after of hypoglycaemia (e.g. Monocytes, granulocytes, lymphocytes). **Measure:** Leukocyte count at the time points **Time Frame:** 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia, +1 day, +3 days and 1 week after of hypoglycaemia **Description:** Ex vivo production of pro- and anti-inflammatory cytokines and chemokines after ex vivo stimulation of isolated leukocytes, including Tumor necrosis factor-α, Interleukin-6, Interleukin-10 and Interleukin-1β, 1β **Measure:** Ex vivo production of pro- and anti-inflammatory cytokines and chemokines **Time Frame:** 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia, +1 day, +3 days and 1 week after of hypoglycaemia **Description:** 92 circulating inflammatory proteins using Olink Proteomics inflammation panel **Measure:** 92 circulating inflammatory proteins **Time Frame:** 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia **Description:** Inflammatory plasma protein using ELISA,(e.g high sensitive-crp) **Measure:** Inflammatory plasma protein ( e.g. high-sensitive crp) **Time Frame:** 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia **Description:** Atherogenic parameters using ELISA including but not limited to, vascular endothelial cell adhesion molecule-1, vascular endothelial cell adhesion molecule-1, E-Selectin, P-selectin, Plasminogen activator inhibitor-1, Plasma Endothelin **Measure:** Atherogenic parameters **Time Frame:** 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia **Description:** Plasma levels of hormones ( Cortisol, insulin, glucagon, growth-hormone, adrenaline, noradrenaline) **Measure:** Plasma levels of hormones **Time Frame:** 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia **Description:** Amount of events **Measure:** Amount of hypoglycaemic events measured by the blinded continuous glucose monitor **Time Frame:** During the full study, 3 days before and 7 days after each investigational day **Description:** Variability of glucose expressed as a standard deviation of the mean glucose **Measure:** Variability measured by the blinded continuous glucose monitor **Time Frame:** During the full study, 3 days before and 7 days after each investigational day **Description:** Average glucose during the 10 days of measuring expressed as mmol/L **Measure:** Average glucose measured by the blinded continuous glucose monitor **Time Frame:** During the full study, 3 days before and 7 days after each investigational day **Description:** Amount of time that glucose is between 3.8 and 10 mmol/L expressed as a percentage **Measure:** Time in range measured by the blinded continuous glucose monitor **Time Frame:** During the full study, 3 days before and 7 days after each investigational day **Description:** Amount of plasma glycerol during and after hypoglycaemia **Measure:** Amount of plasma glycerol **Time Frame:** 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia **Description:** Amount of Non-esterified fatty acids (NEFAs) during and after hypoglycaemia **Measure:** Amount of Non-esterified fatty acids **Time Frame:** 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia **Description:** Measuring a panel of amino acids **Measure:** Untargeted metabolomics profiling **Time Frame:** 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia **Description:** Gene expression changes in leukocytes (e.g. using RNA sequencing, quantitative PCR) **Measure:** Gene expression changes in leukocytes **Time Frame:** 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia **Description:** Epigenetic changes in leukocytes (e.g. using Assay for Transposase- Accessible Chromatin using sequencing (ATACseq), DNA methylation analysis) **Measure:** Epigenetic changes in leukocytes **Time Frame:** 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia **Description:** Functional changes in monocytes (e.g. using adhesion assays, differentiation experiments) **Measure:** Functional changes in monocytes **Time Frame:** 0, 30 minutes after euglycaemia, 60 minutes during hypoglycaemia **Measure:** Adrenergic symptoms assessed using the validated Edinburgh Hypoglycaemia Score **Time Frame:** 0, 30 minutes after euglycaemia, 30 minutes and 60 minutes during hypoglycaemia **Measure:** Hypoglycaemia awareness using the modified Clarke score **Time Frame:** At screening ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Overall inclusion criteria: * Ability to provide written informed consent * Body-Mass Index: 18,5-35 kg/m2 * Age ≥16 years, ≤ 75 years * Blood pressure: \<140/90 mmHg * Non-smoking * Electrocardiogram not showing any serious arrythmias (premature ventricular complexes and premature atrial complexes accepted) Diabetes group specific criteria: * Insulin treatment according to basal-bolus insulin regimen (injections or insulin pump) * Duration of diabetes \> 1 year * HbA1c \< 100 mmol/mol, Exclusion Criteria: * Any event of cardiovascular disease in the past 5 years (e.g. myocardial infarction, stroke, symptomatic peripheral arterial disease) * Pregnancy or breastfeeding or unwillingness to undertake measures for birth control * Active epilepsy ( with the need for treatment) * Allergy for sulphite * Active asthma with use of β2-bronchodilators or obstructive lung disease * Current treatment with Alpha- or beta-blockers (e.g. doxazosin, propranolol) * History of clinical significant Arrhythmias * Use of immune-modifying drugs or antibiotics * Use of antidepressants ( Including monoamine oxidase inhibitors, tricyclic antidepressants and serotonin-reuptake inhibitors) * Use of antipsychotics * Use of statins with the inability to stop statins \>2 weeks before the investigational day. * Proliferative retinopathy * Nephropathy with an estimated glomerular filtration rate (by Chronic Kidney Disease Epidemiology Collaboration equation, CKD-EPI) ˂60ml/min/1.73m2 **Gender Based:** True **Gender Description:** We aim to match our participants with each other to have comparable groups. So we aim to have the same amount of males and females. **Healthy Volunteers:** True **Maximum Age:** 75 Years **Minimum Age:** 16 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ilyas Mustafajev, M.D. **Phone:** 0629669369 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Rick Meijer, MD, PhD **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Radboud University Medical Center (Radboudumc) **Name:** Cees Tack, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** The coordinating researcher will review access requests. Seeing as the data are all anonymized access will be granted for additional research in the field of inflammation or diabetes. **Description:** We will share the study protocol using a data repository accessible through the research team on demand. Starting around 6 months after publication. **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES **Time Frame:** 6 months after publication ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000010335 - Term: Pathologic Processes - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M10293 - Name: Inflammation - Relevance: HIGH - As Found: Inflammation - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes - ID: M7117 - Name: Diabetes Mellitus, Type 1 - Relevance: HIGH - As Found: Diabetes Mellitus, Type 1 - ID: M10053 - Name: Hypoglycemia - Relevance: HIGH - As Found: Hypoglycemia - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003922 - Term: Diabetes Mellitus, Type 1 - ID: D000007003 - Term: Hypoglycemia - ID: D000007249 - Term: Inflammation ### Intervention Browse Module - Ancestors - ID: D000000319 - Term: Adrenergic beta-Antagonists - ID: D000018674 - Term: Adrenergic Antagonists - ID: D000018663 - Term: Adrenergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000889 - Term: Anti-Arrhythmia Agents - ID: D000000959 - Term: Antihypertensive Agents - ID: D000014665 - Term: Vasodilator Agents - ID: D000000317 - Term: Adrenergic alpha-Antagonists ### Intervention Browse Module - Browse Branches - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: AnAg - Name: Antihypertensive Agents - Abbrev: VaDiAg - Name: Vasodilator Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Hypo - Name: Hypoglycemic Agents ### Intervention Browse Module - Browse Leaves - ID: M14298 - Name: Propranolol - Relevance: HIGH - As Found: Entinostat - ID: M10365 - Name: Insulin - Relevance: LOW - As Found: Unknown - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: LOW - As Found: Unknown - ID: M10054 - Name: Hypoglycemic Agents - Relevance: HIGH - As Found: Incisional - ID: M13551 - Name: Phentolamine - Relevance: HIGH - As Found: Cis-platinum - ID: M20746 - Name: Adrenergic Agents - Relevance: LOW - As Found: Unknown - ID: M3671 - Name: Adrenergic beta-Antagonists - Relevance: LOW - As Found: Unknown - ID: M20755 - Name: Adrenergic Antagonists - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: M4213 - Name: Anti-Arrhythmia Agents - Relevance: LOW - As Found: Unknown - ID: M4277 - Name: Antihypertensive Agents - Relevance: LOW - As Found: Unknown - ID: M17412 - Name: Vasodilator Agents - Relevance: LOW - As Found: Unknown - ID: M3669 - Name: Adrenergic alpha-Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000011433 - Term: Propranolol - ID: D000010646 - Term: Phentolamine ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422481 **Acronym:** MYOLOAD **Brief Title:** Echocardiographic Measurement of Myocardial Work **Official Title:** Non-invasive Measurement of Myocardial Work Using Transthoracic Echocardiography in Critically Ill Patients: the MYOLOAD Study #### Organization Study ID Info **ID:** 24-PP-04 #### Organization **Class:** OTHER **Full Name:** Centre Hospitalier Universitaire de Nice ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Centre Hospitalier Universitaire de Nice #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Echocardiography is recommended for the hemodynamic management of patients with shock. Recently, a new echocardiographic method has been proposed that provides a non-invasive measurement of myocardial work incorporating different components, namely total myocardial work (GWI), constructive myocardial work (GCW), lost myocardial work (GWW) and effective myocardial work (GWE). Echocardiographic measurement of myocardial work takes into account both myocardial deformation and left ventricular afterload (estimated by measuring systolic blood pressure) and, unlike the measurement of left ventricular ejection fraction and global longitudinal strain, could be less dependent on cardiac load conditions, particularly left ventricular afterload. To date, non-invasive measurement of myocardial work has never been validated in critically ill patients, and no study has assessed the effects of different therapies (fluids administration, administration of norepinephrine) on the different components of myocardial work in patients admitted to intensive care unit. ### Conditions Module **Conditions:** - Cardiovascular Physiological Phenomena - Intensive Care Unit Syndrome ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 110 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Fluid administration **Label:** Fluids **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Other: Norepinephrine administration or increase in norepinephrine dosage **Label:** Norepinephrine **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Fluids **Description:** Patients will receive fluid administration (500 mL of saline over 30 minutes). The indication of fluid administration will be left to the discretion of the attending physician. **Name:** Fluid administration **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Norepinephrine **Description:** Patients will receive norepinephrine or norepinephrine dosage will be increased if necessary to achieve the appropriate mean arterial pressure level. The indication of norepinephrine administration or increase in norepinephrine dosage will be left to the discretion of the attending physician. **Name:** Norepinephrine administration or increase in norepinephrine dosage **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The primary outcome will be assess by evaluating the proportion of patients in whom non-invasive echocardiographic measurement of myocardial work is obtained. **Measure:** Determine the feasibility of echocardiographic measurement **Time Frame:** through study completion, an average of 1 year #### Secondary Outcomes **Description:** The measurement of myocardial work will be performed non-invasively by cardiac ultrasound. The secondary outcomes will be assess the impact of fluid administration on the different components of myocardial work. as follows: (i) fluid-induced changes in the different components of myocardial work, (ii) concordance between changes in myocardial work and changes in cardiac output induced by fluid administration (iii), the ability of the different components of myocardial work to predict fluid responsiveness. **Measure:** measurement of myocardial by cardiac ultrasound during fluid administration **Time Frame:** through study completion, an average of 1 year **Description:** The measurement of myocardial work will be performed non-invasively by cardiac ultrasound. The secondary outcomes will be assess the impact of norepinephrine administration on the different components of myocardial work. as follows: (i) norepinephrine-induced changes in the different components of myocardial work, (ii) concordance between changes in myocardial work and changes in cardiac output induced by norepinephrine and (iii), the ability of the different components of myocardial work to predict fluid responsiveness. **Measure:** measurement of myocardial by cardiac ultrasound norepinephrine administration **Time Frame:** through study completion, an average of 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Indication to fluid administration left to the discretion of the attending physician * Indication to norepinephrine administration or increase in norepinephrine dosage left to the discretion of the attending physician. Exclusion Criteria: * Patients under protection. * Patients with do not ressuscitate order. * Patients with severe left-side or right-side valvulopathy. * Patients with atrial fibrillation. * Patients with ventricular aneuvrysm or severe regional wall motion abnormalities. * Patients with a pacemaker. * Patients' objections to the collection of their health data. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Mathieu Jozwiak, MD **Phone:** +33492035510 **Role:** CONTACT #### Locations **Location 1:** **City:** Nice **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Mathieu Jozwiak, MD - **Phone:** +33492035510 - **Role:** CONTACT ***Contact 2:*** - **Name:** THOMAS CITTI - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** CHU de NICE ARCHET **State:** CHU De Nice **Zip:** 06000 **Location 2:** **City:** Nice **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** DENIS DOYEN, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** DENIS DOYEN, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** CHU de NICE PASTEUR **State:** CHU De Nice **Zip:** 06000 **Location 3:** **City:** Marseille **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** CYRIL NAFATI, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** CYRIL NAFATI, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** Aphm Hopital La Timone ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M19010 - Name: Critical Illness - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - ID: D000000316 - Term: Adrenergic alpha-Agonists - ID: D000000322 - Term: Adrenergic Agonists - ID: D000018663 - Term: Adrenergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000013566 - Term: Sympathomimetics - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000014662 - Term: Vasoconstrictor Agents ### Intervention Browse Module - Browse Branches - Abbrev: VaCoAg - Name: Vasoconstrictor Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M12575 - Name: Norepinephrine - Relevance: HIGH - As Found: Health education - ID: M20746 - Name: Adrenergic Agents - Relevance: LOW - As Found: Unknown - ID: M3668 - Name: Adrenergic alpha-Agonists - Relevance: LOW - As Found: Unknown - ID: M3673 - Name: Adrenergic Agonists - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: M16345 - Name: Sympathomimetics - Relevance: LOW - As Found: Unknown - ID: M17409 - Name: Vasoconstrictor Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000009638 - Term: Norepinephrine ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422468 **Acronym:** CARDS-pilot **Brief Title:** Combining Accelerometer, Gyroscope, Sound, Electrocardiography and Photoplethysmography Data in Cardiac Monitoring **Official Title:** Combining Accelerometer, Gyroscope, Sound, Electrocardiography and Photoplethysmography Data in Cardiac Monitoring: a Pilot Study #### Organization Study ID Info **ID:** Z-2023103 #### Organization **Class:** INDUSTRY **Full Name:** Qompium NV ### Status Module #### Completion Date **Date:** 2024-08-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-08-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-21 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-02-08 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Qompium NV #### 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 interventional clinical trial is to investigate whether combining photoplethysmography (PPG) signals with accelerometer (ACC), gyroscope (GYR), sound, and electrocardiography (ECG) derived smartphone data provides additional insights into the cardiac condition of individuals with and without atrial fibrillation (AF). ### Conditions Module **Conditions:** - Atrial Fibrillation **Keywords:** - Photoplethysmography - Single-lead Electrocardiography ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 125 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Device: FibriCheck recordings **Label:** FibriCheck recordings **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - FibriCheck recordings **Description:** PPG, ACC, GYR, ECG and sound measurements **Name:** FibriCheck recordings **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Detect or identify specific morphologic characteristics (changes or correlations) by the comparison of PPG signals, accelerometer signals, gyroscope signals, sound signals and ECG signals, derived via the smartphone data. **Measure:** Identification of morphologic characteristics of smartphone generated signals **Time Frame:** 1 day #### Secondary Outcomes **Description:** Evaluate the performance of our PPG FibriCheck Algorithm in cardiology patients and healthy volunteers, based on simultaneously recorded ECG data (RR intervals). **Measure:** Evaluate the performance of the FibriCheck Algorithm **Time Frame:** 1 day ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Inclusion criteria applicable for all groups: * At least 18 years old * Participants must have the ability to understand and provide written informed consent * Participants must have the ability to understand Dutch Group specific inclusion criteria: Group 1: Healthy volunteers * No cardiac conditions based on medical history. Group 2: Cardiology patients * Patients at the consultation or ambulatory unit of Cardiology (pre- cardioversion, pre-pulmonary vein isolation) with AF. * Patients without AF but with a current cardiac condition (e.g. heart failure with a reduced or preserved ejection fraction) or a history of a cardiac condition (e.g. history of myocardial infarction). Exclusion Criteria: * Individuals with unnaturally coloured fingers (i.e. tattoos, ink); this may weaken the signal and may interfere with the effectiveness of the device * Persons with conditions causing tremors or the inability to hold their hand still for at least 60 seconds (e.g. Parkinson or dementia) as, in this case, the device may not be able to accurately process a measurement * Persons with reduced blood flow in the fingertips (e.g. perniosis or severe callus formation) as the device may not be able to detect the intensity variations induced by the blood flow * Persons that have a disability to perform the measurements according to the instructions for use * Persons with cardiac pacemakers, implantable cardioverter-defibrillators, or other implanted electronic devices as these can control the natural heart rhythm **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Lars Grieten, PhD **Phone:** +3211485953 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Annelies Geeraerts, PhD **Phone:** +3211485953 **Role:** CONTACT #### Locations **Location 1:** **City:** Genk **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Pieter Vandervoort, MD - **Phone:** 089/325050 - **Role:** CONTACT **Country:** Belgium **Facility:** Ziekenhuis Oost Limburg **State:** Limburg **Status:** RECRUITING **Zip:** 3600 #### Overall Officials **Official 1:** **Affiliation:** Ziekenhuis Oost-Limburg **Name:** Pieter Vandervoort, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001145 - Term: Arrhythmias, Cardiac - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - 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: M4453 - Name: Arrhythmias, Cardiac - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001281 - Term: Atrial Fibrillation ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06422455 **Brief Title:** Access to Genetic Testing in Underserved Patients With Cancer **Official Title:** Increasing Access to Genetic Testing in Underserved Patients Using a Multilingual Conversational Agent #### Organization Study ID Info **ID:** 19PS-22-3 #### Organization **Class:** OTHER **Full Name:** University of Southern California #### Secondary ID Infos **Domain:** CTRP (Clinical Trial Reporting Program) **ID:** NCI-2024-02187 **Type:** REGISTRY **Domain:** USC / Norris Comprehensive Cancer Center **ID:** 19PS-22-3 **Type:** OTHER **ID:** P30CA014089 **Link:** https://reporter.nih.gov/quickSearch/P30CA014089 **Type:** NIH **ID:** R01CA263532 **Link:** https://reporter.nih.gov/quickSearch/R01CA263532 **Type:** NIH ### Status Module #### Completion Date **Date:** 2027-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Cancer Institute (NCI) #### Lead Sponsor **Class:** OTHER **Name:** University of Southern California #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study compares the experiences of people who receive information about genetic testing from a computer-generated character to patients who receive information from a human genetics healthcare provider. Patients with cancer are increasingly recommended for genetic testing as standard of care. Multiple factors contribute to low usage of genetic testing but for many patients the lack of access to genetic counseling and testing is an important and flexible factor. Lack of access is especially relevant to racial/ethnic minority patients and those living in non-metropolitan rural settings who are frequently cared for at safety-net hospitals with limited genetics services. Alternative delivery models are necessary to improve rates of access to genetic testing in patients with cancer. Health information technology is under used by genetics providers. A patient-facing relational agent (PERLA) will provide pre-test genetics education in both English and Spanish across two clinical settings to facilitate more timely access to genetic testing. Using the PERLA intervention may help researchers learn different ways to provide education about genetic testing to patients with cancer compared to usual care. **Detailed Description:** PRIMARY OBJECTIVES: I. To obtain patient and provider input on the optimal content and format of a new relational agent (RA) intervention ("PERLA") for automated pre-test genetics education. II. To obtain patient feedback on the usability of the English- and Spanish-language PERLAs. III. To determine the acceptability of the newly designed English- and Spanish-language PERLAs among patients with cancer. IV. To evaluate the impact of the English- and Spanish-language PERLAs on the proportion of patients who meet cancer-based genetic testing guidelines who receive genetic test results within 3 months of initiating cancer care. V. To evaluate the potential barriers and facilitators to implementation of PERLA in the clinical setting. OUTLINE: DEVELOPMENT PHASE: Participants attend focus groups and provide feedback on the content, format, and usability of the PERLAs to enable to tailor the design of the intervention. USABILITY PHASE: Participants attend usability testing and provide feedback through cognitive interviews. PILOT TESTING PHASE: Participants evaluate the newly developed PERLAs and provide feedback through focused interviews and structured assessment. INTERVENTION PHASE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive access to PERLA comprising pre-test genetics education and standard post-test provider-based genetic counseling over 20-60 minutes. ARM B: Patients receive access to usual care pre- and post-test provider-based genetic counseling. IMPLEMENTATION PHASE: Participants complete qualitative interviews to evaluate potential barriers and facilitators to implementation of PERLA in the clinic. After completion of study intervention, patients are followed up at 1, 3, and 6 months. ### Conditions Module **Conditions:** - Breast Carcinoma - Male Breast Carcinoma - Malignant Solid Neoplasm - Metastatic Prostate Carcinoma - Ovarian Carcinoma - Pancreatic Exocrine Neoplasm - Stage IVB Prostate Cancer American Joint Committee on Cancer v8 - Triple-Negative Breast Carcinoma ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 800 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients receive access to PERLA comprising pre-test genetics education and standard post-test provider-based genetic counseling over 20-60 minutes. . **Intervention Names:** - Other: Educational Intervention - Other: Electronic Health Record Review - Other: Genetic Counseling - Other: Interview - Other: Survey Administration **Label:** Intervention Phase Arm A (PERLA) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients receive access to usual care pre- and post-test provider-based genetic counseling. **Intervention Names:** - Other: Best Practice - Other: Electronic Health Record Review - Other: Survey Administration **Label:** Intervention Phase Arm B (usual care) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention Phase Arm B (usual care) **Description:** Receive provider-based genetic counseling **Name:** Best Practice **Other Names:** - standard of care - standard therapy **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Intervention Phase Arm A (PERLA) **Description:** Receive genetics education **Name:** Educational Intervention **Other Names:** - Education for Intervention - Intervention by Education - Intervention through Education - Intervention, Educational **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Intervention Phase Arm A (PERLA) - Intervention Phase Arm B (usual care) **Description:** Ancillary studies **Name:** Electronic Health Record Review **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - Intervention Phase Arm A (PERLA) **Description:** Receive provider-based genetic counseling **Name:** Genetic Counseling **Type:** OTHER #### Intervention 5 **Arm Group Labels:** - Intervention Phase Arm A (PERLA) **Description:** Ancillary studies **Name:** Interview **Type:** OTHER #### Intervention 6 **Arm Group Labels:** - Intervention Phase Arm A (PERLA) - Intervention Phase Arm B (usual care) **Description:** Ancillary studies **Name:** Survey Administration **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The proportion of participants who receive genetic testing will be reported. **Measure:** Proportion of participants who receive genetic testing **Time Frame:** Up 3 months #### Secondary Outcomes **Description:** Correlations with patient level factors, such as education, literacy, acculturation, and language will be examined. **Measure:** Patient-reported outcomes **Time Frame:** Up to 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age \> 18 years old * Diagnosed with least one of the following: * Epithelial ovarian cancer * Exocrine pancreatic cancer * Metastatic or high or very high-risk prostate cancer * Breast cancer at or before age 50 * Bilateral breast cancer * Triple negative breast cancer * Male breast cancer OR * Healthcare provider who treats patients with any of the above types of cancer * Able to read and write in English or Spanish * Able to provide informed consent Exclusion Criteria: * Patients who cannot provide informed consent * Patients who cannot see, read, or write * Patients who have the cancer and clinical characteristics defined in the inclusion criteria, but who do not speak English or Spanish * Patients with none of the listed cancer diagnoses and clinical characteristics * Healthcare provider who do not treats cancer patients **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Charite Ricker, MS **Phone:** 323-409-7710 **Role:** CONTACT #### Locations **Location 1:** **City:** Los Angeles **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Charite Ricker - **Phone:** 323-409-7710 - **Role:** CONTACT ***Contact 2:*** - **Name:** Charite Ricker - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** USC / Norris Comprehensive Cancer Center **State:** California **Zip:** 90033 **Location 2:** **City:** Rochester **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Meghan L. Underhill - **Role:** CONTACT ***Contact 2:*** - **Name:** Meghan L. Underhill - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of Rochester **State:** New York **Zip:** 14642 #### Overall Officials **Official 1:** **Affiliation:** University of Southern California **Name:** Charite Ricker, MS **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009371 - Term: Neoplasms by Site - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin 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: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M12974 - Name: Ovarian Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Carcinoma - ID: M14335 - Name: Prostatic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M1704 - Name: Carcinoma, Ovarian Epithelial - Relevance: LOW - As Found: Unknown - ID: M20665 - Name: Breast Neoplasms, Male - Relevance: HIGH - As Found: Male Breast Carcinoma - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: T4352 - Name: Ovarian Cancer - Relevance: LOW - As Found: Unknown - ID: T4354 - Name: Ovarian Epithelial Cancer - Relevance: LOW - As Found: Unknown - ID: T861 - Name: Breast Cancer, Male - Relevance: HIGH - As Found: Male Breast Carcinoma ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000009369 - Term: Neoplasms - ID: D000001943 - Term: Breast Neoplasms - ID: D000018567 - Term: Breast Neoplasms, Male ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False