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## Protocol Section ### Identification Module **NCT ID:** NCT06415032 **Acronym:** BE-Quilt **Brief Title:** Quilting Sutures After Mastectomy **Official Title:** Comparison of 'Quilting Sutures' With 'Conventional Sutures and Drain Placement' After Mastectomy: a Multicentre, Pragmatic Randomised Controlled Trial #### Organization Study ID Info **ID:** S66948 #### Organization **Class:** OTHER **Full Name:** Universitaire Ziekenhuizen KU Leuven ### Status Module #### Completion Date **Date:** 2027-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Belgium Health Care Knowledge Centre #### Lead Sponsor **Class:** OTHER **Name:** Universitaire Ziekenhuizen KU Leuven #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The use of wound drains after mastectomy is common practice in Belgium. However, placement of suction drainage has several disadvantages. Skin bacteria can enter via the drain and cause infection, or the drain itself can cause discomfort and a need for daily nursing. After drain removal, seroma is the most common complication following breast cancer surgery. Seromas are collections of serous fluid that frequently develop under the skin or in the axillary space formed after mastectomy and/or axillary lymph node dissection, resulting from surgical trauma to blood/lymphatic vessels and post-traumatic inflammation. Seroma formation can cause discomfort and limitations in shoulder function. Moreover, it is associated with surgical site infections, often requires treatment and increases healthcare consumption. Wound healing problems might be a cause of postponement of adjuvant therapy. The quilting suture technique, in which the skin is sutured to the pectoralis muscle and drain placement is not needed, may lead to a significant reduction of seroma with a decrease in the number of aspirations and surgical site infections. In this national multicentric study, we will compare mastectomy with placement of suction drains, a standard technique used in the vast majority of Belgian hospitals, with the new quilting suture technique without placement of suction drains. We will focus on 3 distinct primary outcomes: * Pain of the mastectomy area 6 months after surgery * Upper limb function 6 months after surgery * Cosmetic outcome scored by the patient 6 months after surgery. The goal of this study is to demonstrate the absence of long-term negative effects of the quilting suture technique on shoulder function, cosmetic outcome, and pain management. ### Conditions Module **Conditions:** - Breast Cancer **Keywords:** - Mastectomy - Drain policy - Pain - Upper limb function - Cosmetic outcome - Quilting ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** A multicentre, pragmatic randomised controlled trial ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 296 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Procedure: Mastectomy with Quilting sutures without drain placement **Label:** Quilting sutures without drain placement **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Procedure: Mastectomy with Conventional sutures with drain placement **Label:** Conventional sutures with drain placement **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Quilting sutures without drain placement **Description:** The nipple-areola complex is removed, and dissection of skin flaps is performed using electrocautery. The breast tissue, including the prepectoral fascia is removed from the pectoral muscle. After the mastectomy, the skin flaps are sutured onto the pectoral muscle using polyfilament absorbable sutures (e.g. Stratafix PDS® 1 CT needle) placed at 4- to 5-cm intervals in two or three rows depending on the extent of the skin flaps. Care is taken to prevent dimpling of the skin. The axillary region is also approximated. Care is taken to prevent damage to nerves and blood vessels. No suction drains are placed. For skin closure, the edges are sutured using absorbable monofilament sutures (e.g. Biosyn l® 3-0, Monocryl® 3-0) depending on the surgeon's preference. **Name:** Mastectomy with Quilting sutures without drain placement **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Conventional sutures with drain placement **Description:** The nipple-areola complex is removed, and dissection of skin flaps is performed using electrocautery. The breast tissue, including the prepectoral fascia is removed from the pectoral muscle. After mastectomy no flap fixation is performed. The skin is closed in a conventional manner using an absorbable skin suture. One or two suction drains are placed before skin closure. The drains are placed in the mastectomy gutter lateral to the pectoral muscle and/or in the prepectoral area. For skin closure, the edges are sutured using absorbable monofilament sutures (e.g. Biosyn l® 3-0, Monocryl® 3-0) depending on the surgeon's preference. Drain output is recorded daily. Drain removal policy varies among participating centres. In some centres drain removal is based on volume of drained fluids while in other centres it depends on the postoperative time **Name:** Mastectomy with Conventional sutures with drain placement **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** A non-inferiority margin of 10 mm was adopted, which implies that a difference between both arms up to 10 mm in favour of the standard approach would be clinically acceptable **Measure:** Pain in the mastectomy area scored by VAS **Time Frame:** 6 months postoperative **Description:** A non-inferiority margin of 10 points was adopted, which implies that a difference between both arms up to 10 points in favour of the standard approach would be clinically acceptable. **Measure:** Upper limb function scored by QuickDASH **Time Frame:** 6 months postoperative **Description:** A non-inferiority margin of 1 point on the 10-point scale was adopted which implies that a difference between both arms up to 1 point in favour of the standard approach would be clinically acceptable **Measure:** Cosmetic outcome scored by the patient on a 10-point scale **Time Frame:** 6 months postoperative ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * capable of giving written informed consent * age ≥ 18 years * scheduled for unilateral mastectomy without immediate breast reconstruction with or without axillary surgery (sentinel lymph node biopsy or axillary lymph node dissection) Exclusion Criteria: * scheduled for mastectomy with immediate breast reconstruction * scheduled for synchronous bilateral breast and/or axillary surgery **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Leuven **Contacts:** ***Contact 1:*** - **Email:** hanne.vos@uzleuven.be - **Name:** Hanne Vos, PhD - **Phone:** 016340903 - **Role:** CONTACT ***Contact 2:*** - **Name:** Ann Smeets, MD, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Belgium **Facility:** Surgical Oncology, UZ Leuven **Zip:** 3000 #### Overall Officials **Official 1:** **Affiliation:** UZ Leuven **Name:** Ann Smeets, MD,PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06415019 **Brief Title:** A Study to Learn About Whether BAY H006689 Causes an Allergic Reaction When Applied as a Topical Gel in Healthy Participants **Official Title:** A Randomized, Controlled Study to Evaluate the Sensitizing Potential of BAY H006689, Naproxen 10% Topical Gel in Healthy Subjects Using a Repeat Insult Patch Test Design #### Organization Study ID Info **ID:** 22640 #### Organization **Class:** INDUSTRY **Full Name:** Bayer ### Status Module #### Completion Date **Date:** 2024-07-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-07-20 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-21 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Bayer #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** Researchers are looking for a better way to treat muscle and joint pain. Researchers have seen that medicines which help reduce pain and inflammation could be safer when applied directly to the skin, called topical application, than when taken by mouth. However, recent studies have found that using these medicines on the skin can sometimes cause skin reactions such as redness, itching, or irritation in the area where the medicine is applied. However, reports of more serious side effects, affecting the entire body, from using these topical medicines are uncommon. The study treatment BAYH006689 is under development to treat muscle and joint pain. In this study, participants will be healthy and will not benefit from BAYH006689. However, the study will provide information on how to test BAYH006689 in future studies in people with muscle and joint pain. The main purpose of this study is to check if BAYH006689 topical gel causes any skin reactions in healthy participants. The skin reactions will be assessed using a scale. This scale will provide scores for redness, swelling, and other signs of skin irritation. In this study, researchers will randomly assign 3 sites, adjacent to each other, on the back of participants' bodies just below the shoulder blades. The following gels will be applied 10 times at these sites as a patch three times a week for 21 days and once after 14-17 days: * BAYH006689 * Placebo, which looks like the study drug but does not have any medicine in it. * 0.9 % saline Each participant will be in the study for around 6 to 8 weeks. During this time they will: * receive assigned treatment gels at the identified skin sites * have their skin reaction symptoms assessed During the study, the doctors and their study team will: * check the medical history of the participants * check participants' health by performing urine tests * ask the participants questions about how they are feeling and 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 or not to the study treatment. ### Conditions Module **Conditions:** - Pain - Healthy Volunteers ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Masking Description:** The treatments (IPs and control) will not be blinded to investigative personnel involved in the preparation/application and removal of treatments. However, the Investigator and trained evaluator involved in the evaluation of responses, will remain blinded during the course of the study until Database Lock and finalization of the Statistical Analysis Plan. **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 240 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Topical application of BAYH006689 naproxen 10% topical gel on the intact skin **Intervention Names:** - Drug: Naproxen (BAYH006689) **Label:** BAYHO06689 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Topical application of placebo gel which contains 0% of naproxen on the intact skin **Intervention Names:** - Drug: Placebo Gel **Label:** Placebo **Type:** PLACEBO_COMPARATOR #### Arm Group 3 **Description:** Topical application of the sterile 0.9% saline (negative control) on the intact skin **Intervention Names:** - Drug: A solution of 0.9% Saline **Label:** Negative control **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - BAYHO06689 **Description:** BAYH006689 gel will be dispensed directly on the patch **Name:** Naproxen (BAYH006689) **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Placebo gel will be dispensed directly on the patch **Name:** Placebo Gel **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Negative control **Description:** 0.9% Saline will be dispensed directly on the patch. **Name:** A solution of 0.9% Saline **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Skin sensitization will be based on specific scoring criteria. **Measure:** Skin sensitization potential **Time Frame:** Up to 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy adult * Is 18 years of age or older * Free of any systemic or dermatological disorder that may interfere with results or increase risk of adverse events (AEs) Exclusion Criteria: * Has a condition and/or is using medications that may interfere with the study results * Pregnant or planning to get pregnant or breastfeeding * Is currently participating in any clinical testing **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** clinical-trials-contact@bayer.com **Name:** Bayer Clinical Trials Contact **Phone:** (+)1-888-84 22937 **Role:** CONTACT #### Locations **Location 1:** **City:** Fair Lawn **Country:** United States **Facility:** TKL Research, Inc. **State:** New Jersey **Zip:** 07410 ### 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 ### References Module #### See Also Links **Label:** Click here to find further information and, after study completion, the study results according to Bayer's transparency standards **URL:** https://clinicaltrials.bayer.com/study/22640 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - ID: D000000894 - Term: Anti-Inflammatory Agents, Non-Steroidal - ID: D000018712 - Term: Analgesics, Non-Narcotic - ID: D000000700 - Term: Analgesics - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000018501 - Term: Antirheumatic Agents - ID: D000006074 - Term: Gout Suppressants - ID: D000016861 - Term: Cyclooxygenase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Analg - Name: Analgesics - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PhSol - Name: Pharmaceutical Solutions ### Intervention Browse Module - Browse Leaves - ID: M12239 - Name: Naproxen - Relevance: HIGH - As Found: ACT - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M4218 - Name: Anti-Inflammatory Agents, Non-Steroidal - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M20786 - Name: Analgesics, Non-Narcotic - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: M19209 - Name: Cyclooxygenase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000009288 - Term: Naproxen ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06415006 **Brief Title:** Can Shock Indices Be Prognostic Indicators in Sepsis/Septic Shock? **Official Title:** Can Shock Indices Be Prognostic Indicators in Sepsis/Septic Shock? #### Organization Study ID Info **ID:** 2023-24-20 #### Organization **Class:** OTHER_GOV **Full Name:** Başakşehir Çam & Sakura City Hospital ### Status Module #### Completion Date **Date:** 2024-02-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-11-01 **Type:** ACTUAL #### Start Date **Date:** 2012-12-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi #### Lead Sponsor **Class:** OTHER_GOV **Name:** Başakşehir Çam & Sakura City Hospital #### Responsible Party **Investigator Affiliation:** Başakşehir Çam & Sakura City Hospital **Investigator Full Name:** Furkan Tontu **Investigator Title:** Doctor of Anesthesiology and Reanimation **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** We evaluated the ability of shock indices and hemodynamic parameters to predict 28-day ICU mortality. **Detailed Description:** Shock indices and hemodynamic parameters are significant determinants of mortality in adult ICU patients. This study aimed to evaluate the potential of four known shock indices Shock Index (SI), Age-adjusted Shock Index (aSI), Diastolic Shock Index (dSI), and hemodynamic parameters including Heart Rate (HR), Systolic Arterial Blood Pressure (ABPsys), Diastolic Arterial Blood Pressure (ABPdias), and Mean Arterial Blood Pressure (ABPmean) in predicting 28-day ICU mortality in patients diagnosed with sepsis and septic shock. ### Conditions Module **Conditions:** - Shock, Septic - Hemodynamic Instability ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 1522 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The group consists of 1,522 patients treated in the intensive care unit for sepsis/septic shock. **Intervention Names:** - Procedure: Measurement of hemodynamic parameters. **Label:** Group Sepsis ### Interventions #### Intervention 1 **Arm Group Labels:** - Group Sepsis **Description:** The measurement and recording of Heart Rate (HR), Systolic Arterial Blood Pressure (ABPsys), Diastolic Arterial Blood Pressure (ABPdias), Mean Arterial Blood Pressure (ABPmean), and age parameters. **Name:** Measurement of hemodynamic parameters. **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The predictive power of the Shock Index (SI) parameter for 28-day mortality in sepsis patients treated in the intensive care unit. **Measure:** Shock Index (SI) **Time Frame:** During the first 7 hours in the ICU **Description:** The predictive power of the Age-adjusted Shock Index (aSI) parameter for 28-day mortality in sepsis patients treated in the intensive care unit. **Measure:** Age-adjusted Shock Index (aSI) **Time Frame:** During the first 7 hours in the ICU **Description:** The predictive power of the Diastolic Shock Index (dSI) parameter for 28-day mortality in sepsis patients treated in the intensive care unit. **Measure:** Diastolic Shock Index (dSI) **Time Frame:** During the first 7 hours in the ICU **Description:** The predictive power of the modified Shock Index (mSI) parameter for 28-day mortality in sepsis patients treated in the intensive care unit. **Measure:** modified Shock Index (mSI) **Time Frame:** During the first 7 hours in the ICU #### Secondary Outcomes **Description:** The predictive power of the Heart Rate (HR) parameter for 28-day mortality in sepsis patients treated in the intensive care unit. **Measure:** Heart Rate (HR) **Time Frame:** During the first 7 hours in the ICU **Description:** The predictive power of the Systolic Arterial Blood Pressure (ABPsys) parameter for 28-day mortality in sepsis patients treated in the intensive care unit. **Measure:** Systolic Arterial Blood Pressure (ABPsys) **Time Frame:** During the first 7 hours in the ICU **Description:** The predictive power of the Diastolic Arterial Blood Pressure (ABPdias) parameter for 28-day mortality in sepsis patients treated in the intensive care unit. **Measure:** Diastolic Arterial Blood Pressure (ABPdias) **Time Frame:** During the first 7 hours in the ICU **Description:** The predictive power of the Mean Arterial Blood Pressure (ABPmean) parameter for 28-day mortality in sepsis patients treated in the intensive care unit. **Measure:** Mean Arterial Blood Pressure (ABPmean) **Time Frame:** During the first 7 hours in the ICU **Description:** The predictive power of the age for 28-day mortality in sepsis patients treated in the intensive care unit. **Measure:** Age **Time Frame:** During the first 7 hours in the ICU ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients with a preliminary diagnosis of sepsis/septic shock in the intensive care unit 2. Adult patients aged between 18 and 80 years Exclusion Criteria: 1. Patients under 18 years old 2. Pregnant patients 3. Patients suspected of having COVID-19 pneumonia 4. Patients with incomplete data 5. Patients for whom outcome information is unavailable due to referral to an external center 6. Patients with confirmed COVID-19, validated by thoracic computed tomography images and nasal swab PCR results 7. Patients discharged from the intensive care unit within 24 hours **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** "1,522 patients treated for sepsis/septic shock in the Anesthesiology and Reanimation intensive care unit at Bakırköy Dr. Sadi Konuk Training and Research Hospital." ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Basaksehir Cam Sakura City Hospital ### IPD Sharing Statement Module **Description:** Not decided yet **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Sadeh R, Shashar S, Shaer E, Slutsky T, Sagy I, Novack V, Zeldetz V. Modified Shock Index as a Predictor for Mortality and Hospitalization Among Patients With Dementia. J Emerg Med. 2022 May;62(5):590-599. doi: 10.1016/j.jemermed.2021.12.023. Epub 2022 Feb 16. **PMID:** 35181187 **Citation:** Bondariyan N, Vakhshoori M, Sadeghpour N, Shafie D. Prognostic Value of Shock Index, Modified Shock Index, and Age-Adjusted Derivatives in Prediction of In-Hospital Mortality in Patients with Acute Decompensated Heart Failure: Persian Registry of Cardiovascular Disease/ Heart Failure Study. Anatol J Cardiol. 2022 Mar;26(3):210-217. doi: 10.5152/AnatolJCardiol.2021.671. **PMID:** 35346907 **Citation:** Pramudyo M, Marindani V, Achmad C, Putra ICS. Modified Shock Index as Simple Clinical Independent Predictor of In-Hospital Mortality in Acute Coronary Syndrome Patients: A Retrospective Cohort Study. Front Cardiovasc Med. 2022 Jun 9;9:915881. doi: 10.3389/fcvm.2022.915881. eCollection 2022. **PMID:** 35757344 **Citation:** Kurt E, Bahadirli S. The Usefulness of Shock Index and Modified Shock Index in Predicting the Outcome of COVID-19 Patients. Disaster Med Public Health Prep. 2022 Aug;16(4):1558-1563. doi: 10.1017/dmp.2021.187. Epub 2021 Jun 8. **PMID:** 34099089 **Citation:** Gokcek K, Gokcek A, Demir A, Yildirim B, Acar E, Alatas OD. In-hospital mortality of acute pulmonary embolism: Predictive value of shock index, modified shock index, and age shock index scores. Med Clin (Barc). 2022 Apr 22;158(8):351-355. doi: 10.1016/j.medcli.2021.04.035. Epub 2021 Aug 14. English, Spanish. **PMID:** 34404518 **Citation:** Kocaoglu S, Karadas A. Comparison of the Effectiveness of Shock Index, Modified Shock Index, and Age Shock Index in COPD Exacerbations. J Coll Physicians Surg Pak. 2022 Sep;32(9):1187-1190. doi: 10.29271/jcpsp.2022.09.1187. **PMID:** 36089718 **Citation:** Vang M, Ostberg M, Steinmetz J, Rasmussen LS. Shock index as a predictor for mortality in trauma patients: a systematic review and meta-analysis. Eur J Trauma Emerg Surg. 2022 Aug;48(4):2559-2566. doi: 10.1007/s00068-022-01932-z. Epub 2022 Mar 8. **PMID:** 35258641 **Citation:** Zhang TN, Hao PH, Gao SY, Liu CF, Yang N. Evaluation of SI, MSI and DSI for very early (3-day) mortality in patients with septic shock. Eur J Med Res. 2022 Nov 3;27(1):227. doi: 10.1186/s40001-022-00857-y. **PMID:** 36329534 **Citation:** Althunayyan SM, Alsofayan YM, Khan AA. Shock index and modified shock index as triage screening tools for sepsis. J Infect Public Health. 2019 Nov-Dec;12(6):822-826. doi: 10.1016/j.jiph.2019.05.002. Epub 2019 May 18. **PMID:** 31113741 **Citation:** Georgette N, Michelson K, Monuteaux M, Eisenberg M. A Temperature- and Age-Adjusted Shock Index for Emergency Department Identification of Pediatric Sepsis. Ann Emerg Med. 2023 Oct;82(4):494-502. doi: 10.1016/j.annemergmed.2023.03.026. Epub 2023 May 12. **PMID:** 37178098 **Citation:** Gupta S, Alam A. Shock Index-A Useful Noninvasive Marker Associated With Age-Specific Early Mortality in Children With Severe Sepsis and Septic Shock: Age-Specific Shock Index Cut-Offs. J Intensive Care Med. 2020 Oct;35(10):984-991. doi: 10.1177/0885066618802779. Epub 2018 Oct 2. **PMID:** 30278814 **Citation:** Avci M, Doganay F. Prognostic Performance of Shock Index, Diastolic Shock Index, Age Shock Index, and Modified Shock Index in COVID-19 Pneumonia. Disaster Med Public Health Prep. 2022 May 2;17:e189. doi: 10.1017/dmp.2022.110. **PMID:** 35492010 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000018805 - Term: Sepsis - ID: D000007239 - Term: Infections - ID: D000018746 - Term: Systemic Inflammatory Response Syndrome - ID: D000007249 - Term: Inflammation - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections ### Condition Browse Module - Browse Leaves - ID: M15577 - Name: Shock - Relevance: HIGH - As Found: Shock - ID: M15580 - Name: Shock, Septic - Relevance: HIGH - As Found: Shock, Septic - ID: M20864 - Name: Sepsis - Relevance: LOW - As Found: Unknown - ID: M16869 - Name: Toxemia - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M20818 - Name: Systemic Inflammatory Response Syndrome - Relevance: LOW - As Found: Unknown - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012772 - Term: Shock, Septic - ID: D000012769 - Term: Shock ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414993 **Acronym:** Launch **Brief Title:** Leveraging Parents and Peers to Increase Recovery Capital in Emerging Adults **Official Title:** Leveraging Parents and Peer Recovery Supports to Increase Recovery Capital in Emerging Adults With Polysubstance Use: Feasibility, Acceptability, and Scaling up of Launch #### Organization Study ID Info **ID:** R34DA057639 **Link:** https://reporter.nih.gov/quickSearch/R34DA057639 **Type:** NIH #### Organization **Class:** OTHER **Full Name:** Chestnut Health Systems #### Secondary ID Infos **ID:** R34DA057639 **Link:** https://reporter.nih.gov/quickSearch/R34DA057639 **Type:** NIH ### Status Module #### Completion Date **Date:** 2025-05-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institute on Drug Abuse (NIDA) #### Lead Sponsor **Class:** OTHER **Name:** Chestnut Health Systems #### Responsible Party **Investigator Affiliation:** Chestnut Health Systems **Investigator Full Name:** Tess Drazdowski **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:** Emerging adults (EAs; aged 18-26) are the highest-risk population for poly-substance use (misuse of more than one drug), compared to all other age groups and are the least-served population for substance use services. The overarching purpose of this pilot study is to assess whether an innovative services package, Launch, can reasonably work (is feasible) and whether providers and participants like it (acceptability). Launch works with both EAs and a supportive parent (or parental figure) and delivers peer recovery support services (PRSS) to EAs while helping parents use an effective, evidence-based program called contingency management, adapted for EAs, at home with their EA child. This study will also lay the groundwork for a future large-scale trial of Launch services. **Detailed Description:** The objective of the study is to investigate a scalable service that can be used in rural communities called Launch. Launch is an innovative adaptation of current evidence-based services for Emerging Adults (EAs), ages 18-26 years old with polysubstance use (poly-SU); with a particular emphasis on increasing their recovery capital. Recovery capital is the resources available to promote substance use recovery (e.g., vocational/educational skills, recovery-supportive community). Launch leverages (1) parents of EAs and (2) peer recovery support services (PRSS), while ensuring services are equitable and scalable by using digital technology and existing substance use services infrastructure. Participants will be 48 families that include an EA struggling with poly-SU and a parent or parental figure supportive of their EA child's recovery journey. Families will be randomized to one of three conditions detailed further in the attached materials that include either: (1) Virtual Parent Contingency Management for Emerging Adults (CM-EA) Coach for parents only, (2) In-Person PRSS for EAs only, or (3) a combination of Virtual Parent CM-EA Coach for parents and In-Person PRSS for EAs. Quantitative and qualitative measures will assess the feasibility and acceptability of Launch. Additionally, payors/providers of substance use services will be interviewed in this study with the aim of improving future uptake and implementation of the service should it be deemed effective. The aims of the study are as follows: 1. Adapt and evaluate the Launch parent coach and PRSS training protocols/adherence tools. 2. Assess the feasibility and acceptability of (a) a virtual study protocol for recruiting, assessing, and retaining parents and EAs and (b) Launch components. 3. Determine from payors and providers the data needed for future funding and delivery of Launch, as well as develop a site recruitment pool for a rigorous R01 trial. ### Conditions Module **Conditions:** - Polysubstance Drug Use (Indiscriminate Drug Use) **Keywords:** - Contingency management - Emerging adults - Polysubstance use - Peer recovery support services ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 48 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The parents in this group will receive CM-EA delivered virtually by a parent coach approximately weekly (20-40 minute sessions) for 6 months. **Intervention Names:** - Behavioral: Contingency Management for Emerging Adults (CM-EA) **Label:** Contingency Management for Emerging Adults (CM-EA) Only **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The EAs in this group will receive PRSS+Vocational/Educational (V/E) Skill Building delivered by peer workers in-person in the local community approximately weekly (1 hour sessions) for 6 months. **Intervention Names:** - Behavioral: Standard Peer Recovery Support Services (PRSS) +Vocational/Educational (V/E) Skill Building services **Label:** Standard Peer Recovery Support Services (PRSS)+Vocational/Educational (V/E) Skill Building **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Families receive both CM-EA and PRSS + V/E as described above. **Intervention Names:** - Behavioral: Contingency Management for Emerging Adults (CM-EA) - Behavioral: Standard Peer Recovery Support Services (PRSS) +Vocational/Educational (V/E) Skill Building services **Label:** CM-EA and PRSS+V/E **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - CM-EA and PRSS+V/E - Contingency Management for Emerging Adults (CM-EA) Only **Description:** After CM-EA is introduced, a contingency contract is developed between a parent and emerging adult (EA) that provides EAs with rewards for negative drug screens and completion of developmentally appropriate goals to build recovery capital, along with disincentives for positive screens or engaging in inappropriate behaviors. Concurrently, parents are taught to conduct random urine drug screens. Additionally, parents are trained to complete functional analyses in collaboration with their EA to identify the EA's triggers for poly-substance use and negative behaviors. Individualized triggers are targeted via self-management planning and drug refusal skills training. At the end of CM-EA, plans are made with the family for sustaining abstinence and improvements in other behaviors. **Name:** Contingency Management for Emerging Adults (CM-EA) **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - CM-EA and PRSS+V/E - Standard Peer Recovery Support Services (PRSS)+Vocational/Educational (V/E) Skill Building **Description:** Standard PRSS begin by identifying clients' needs in key domains (e.g., transportation, employment). After needs are identified, a peer worker addresses needs through informational resources and community referrals and engages clients in positive recreational activities offering advice, hope and empowerment to encourage steps toward a reduction in substance use and eventual abstinence. When desired, peer workers also link clients to a broader recovery peer community. In addition, the peer worker will dedicate time to increasing recovery capital via improving skills related to V/E advancement using a workbook, Targeting Employment for Emerging Adults: A Toolkit for Mental Health Providers, for which peer workers will be trained. **Name:** Standard Peer Recovery Support Services (PRSS) +Vocational/Educational (V/E) Skill Building services **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Levels of acceptability of the Launch intervention, such as if participants like the intervention, as reported by emerging adults on the Acceptability of Intervention Measure. Scores range from 4-20. Higher scores indicate higher levels of intervention acceptability. **Measure:** Levels of Emerging Adult Perceptions of Acceptability of the Launch Intervention (measured at 6 months). **Time Frame:** 6 months **Description:** Levels of acceptability of the Launch intervention, such as if participants like the intervention, as reported by parents on the Acceptability of Intervention Measure. Scores range from 4-20. Higher scores indicate higher levels of intervention acceptability. **Measure:** Levels of Parent Perceptions of Acceptability of the Launch Intervention (measured at 6 months). **Time Frame:** 6 months **Description:** Levels of Launch intervention appropriateness, such as if the intervention is a good match, as reported by emerging adults on the Intervention Appropriateness Measure. Scores range from 4-20. Higher scores indicate higher levels of intervention appropriateness. **Measure:** Levels of Emerging Adult Perceptions of Launch Intervention Appropriateness (measured 6 months). **Time Frame:** 6 months **Description:** Levels of Launch intervention appropriateness, such as if the intervention is a good match, as reported by parents on the Intervention Appropriateness Measure. Scores range from 4-20. Higher scores indicate higher levels of intervention appropriateness. **Measure:** Levels of Parent Perceptions of Launch Intervention Appropriateness (measured 6 months). **Time Frame:** 6 months **Description:** Levels of Launch intervention feasibility, such as if the intervention is easy to use, as reported by emerging adults on the Feasibility of Intervention Measure. Scores range from 4-20. Higher scores indicate higher levels of intervention feasibility. **Measure:** Levels of Emerging Adult Perceptions of Feasibility of the Launch Intervention (measured at 6 months). **Time Frame:** 6 months **Description:** Levels of Launch intervention feasibility, such as if the intervention is easy to use, as reported by parents on the Feasibility of Intervention Measure. Scores range from 4-20. Higher scores indicate higher levels of intervention feasibility. **Measure:** Levels of Parent Perceptions of Feasibility of the Launch Intervention (measured at 6 months). **Time Frame:** 6 months **Description:** Levels of satisfaction with the Launch services reported by emerging adult clients on the Client Satisfaction Questionnaire 8-item scale adapted to reflect receipt of Launch services. **Measure:** Levels of Emerging Adult Client Satisfaction with Launch Services (measured at 6 months). **Time Frame:** 6 months **Description:** Levels of satisfaction with the Launch services reported by parent clients on the Client Satisfaction Questionnaire 8-item scale (CSQ-8) adapted to reflect receipt of Launch services. **Measure:** Levels of Parent Client Satisfaction with Launch Services (measured at 6 months). **Time Frame:** 6 months #### Secondary Outcomes **Description:** Frequency of substance use disorders reported by emerging adults on the Diagnostic and Statistical Manual of Mental Illnesses Version 5 (DSM-5) Substance Use Checklist for the following substance categories: alcohol, cannabis, hallucinogens, inhalants, opioids, sedatives/hypnotics/anxiolytics, stimulants, and an "other" category. **Measure:** Changes from baseline to 6 months post-baseline in Emerging Adult Substance Use Disorders (measured at 0 and 6 months). **Time Frame:** Baseline to 6 months **Description:** Frequency of substance use and substance-related problems reported by emerging adults on the Global Appraisal of Individual Needs (GAIN) and (Justice Community Opioid Innovation Network (JCOIN) Core Measures for the past 30 days. **Measure:** Changes from baseline to 6 months post-baseline in Emerging Adult Substance Use and Problems (measured at 0 and 6 months). **Time Frame:** Baseline to 6 months **Description:** Frequency of polysubstance use reported by emerging adults on the Polysubstance Use Assessment Tool. **Measure:** Changes from baseline to 6 months post-baseline in Emerging Adult Polysubstance Use (measured at 0 and 6 months). **Time Frame:** Baseline to 6 months **Description:** Levels of quality of life reported by emerging adults on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile V2.1, a 31-item measure of quality of life across 7 domains: physical function, anxiety, depression, fatigue, sleep disturbance, social participation, pain interference, pain intensity, and cognitive function. **Measure:** Changes from baseline to 6 months post-baseline in Emerging Adult Quality of Life (measured at 0 and 6 months). **Time Frame:** Baseline to 6 months **Description:** Frequency of service utilization in the past 30 days reported by emerging adults on the JCOIN Core Measures Service Utilization Scale, higher score indicate more service utilization. **Measure:** Changes from baseline to 6 months post-baseline in Emerging Adult Service Utilization (measured at 0 and 6 months). **Time Frame:** Baseline to 6 months **Description:** Levels of abstinence self-efficacy reported by emerging adults on the Abstinence Self Efficacy Scale, higher scores indicate higher abstinence self efficacy. **Measure:** Changes from baseline to 6 months post-baseline in Emerging Adult Abstinence Self Efficacy (measured at 0 and 6 months). **Time Frame:** Baseline to 6 months **Description:** Levels of recovery capital as reported by emerging adult clients on the Emerging Adult Recovery Capital Scale, an emerging adult-specific measure under development by members of the study team and collaborators, higher scores indicate higher recovery capital. **Measure:** Changes from baseline to 6 months post-baseline in Emerging Adult Recovery Capital (measured at 0 and 6 months). **Time Frame:** Baseline to 6 months **Description:** Levels of recovery capital as reported by emerging adult clients on the Brief Assessment of Recovery Capital (BARC-10); higher scores indicate higher levels of recovery capital. **Measure:** Changes from baseline to 6 months post-baseline in Recovery Capital (measured at 0 and 6 months). **Time Frame:** Baseline to 6 months **Description:** Levels of the quality of the relationship between the emerging adult client and the peer worker as reported by emerging adults on the Dual Role Relationship Inventory adapted to assess emerging adults' perceptions of their relationship with their peer worker (among emerging adults assigned to work with a peer worker). **Measure:** Levels of Emerging Adult Client Quality of Relationship with Peer Worker (measured at 6 months). **Time Frame:** 6 months **Description:** Levels of the quality of the relationship between the emerging adult client and their parent as reported by emerging adults on the Dual Role Relationship Inventory adapted to assess emerging adults' perceptions of their relationship with their parent. **Measure:** Levels of Emerging Adult Client Quality of Relationship with Parent (measured at 0 and 6 months). **Time Frame:** Baseline to 6 months **Description:** Frequency of emerging adult attendance at their peer worker sessions (e.g., attended, no show, rescheduled) as reported by the peer worker. **Measure:** Levels of Emerging Adult Session Attendance with Peer Worker (measured weekly from baseline to 6 months). **Time Frame:** Duration of services until 6 months after baseline **Description:** Frequency of parent attendance at their CM-EA parent coach sessions (e.g., attended, no show, rescheduled) as reported by the parent coach. **Measure:** Levels of Parent Session Attendance with CM-EA Parent Coach (measured weekly from baseline to 6 months). **Time Frame:** Duration of services until 6 months after baseline **Description:** Emerging adult attitudes toward the Launch services program, including their perceptions of the acceptability, appropriateness, and feasibility of Launch as well as the research protocol, and impact of services on themselves and their relationship with their parents as measured during qualitative interviews with emerging adults. **Measure:** Attitudes at 6 months post-baseline in Emerging Adult Attitudes Toward the Services Provided, Research Protocol, and Parent/Emerging Adult Relationship (measured at 6 months). **Time Frame:** 6 months **Description:** Parent attitudes toward the Launch services program, including their perceptions of the acceptability, appropriateness, and feasibility of Launch as well as the research protocol, and impact of services on their emerging adult child and their relationship with their emerging adult child as measured during qualitative interviews with parents. **Measure:** Attitudes at 6 months post-baseline in Parent Attitudes Toward the Services Provided, Research Protocol, and Parent/Emerging Adult Relationship (measured at 6 months). **Time Frame:** 6 months **Description:** Peer worker attitudes toward the Launch services program, including their perceptions of the acceptability, appropriateness, and feasibility of Launch, the impact of services on their emerging adult clients, and suggestions for services improvement as measured during qualitative interviews with peer workers. **Measure:** Attitudes at end of services in Peer Worker Attitudes Toward the Services Provided, Impacts on Emerging Adult Clients, and Services Improvement (measured at 6 months). **Time Frame:** From date of consent until the date of two months past last client session completed, assessed up to 2 years **Description:** Parent coach attitudes toward the Launch services program, including their perceptions of the acceptability, appropriateness, and feasibility of Launch, the impact of services on their parent clients, and suggestions for services improvement as measured during qualitative interviews with parent coaches. **Measure:** Attitudes at end of services in Parent Coach Attitudes Toward the Services Provided, Impacts on Parent Clients, and Services Improvement (measured at 6 months). **Time Frame:** From date of consent until the date of two months past last client session completed, assessed up to 2 years **Description:** Frequency of peer worker completion of vocational/educational coaching activities reported by peer workers coaches on the Session Checklist and session tape coding. **Measure:** Changes from baseline to end fo services in Peer Worker Services and Vocational/Educational Activity Completion (measured monthly throughout services duration). **Time Frame:** Duration of services, after each session with an emerging adult until 6 months after baseline **Description:** Adherence to CM-EA practices by parents reported by parent coaches as measured using the CM-Therapist Adherence Measure (CM-TAM) (Self-report version and Tape Coding version). **Measure:** Changes from baseline to end fo services in Parent Contingency Management for Emerging Adults (CM-EA) Adherence (measured monthly throughout services duration). **Time Frame:** Duration of services, after each session with a parent until 6 months after baseline **Description:** Payors and providers of recovery services will report via qualitative interviews on what kinds of participant-level outcomes or economic-related information they would want to know about as the result of a future large-scale study, selection of appropriate comparators for the future cost-effectiveness analysis, and potential recruitment sites for a future large-scale study of Launch. **Measure:** Descriptions of Economic-Related Information for Future Large-Scale Study from Payors/Providers of Recovery Services (measured once at any point during the study period). **Time Frame:** Up to 2 years ### Eligibility Module **Eligibility Criteria:** This study has four different participants: (1) Emerging Adult (EA)/Parent Pairs, (2) Peer Workers, (3) Parent Coaches, and (4) Payors/Providers of Recovery Services. 1. Emerging Adult (EA)/Parent Pairs Inclusion Criteria: * EA (aged 18-26) who reports (1) misuse of opioids and/or stimulants and at least one other substance in the same week during the past 30 days, (2) at least one SU disorder reported by EA or parent as assessed via the DSM-V Checklist, and (3) has a supportive parent willing to be virtually coached to deliver CM-EA. Participating "parents" can include any supportive adult who is in a financially supportive caregiving role for the EA and has the desire and ability to implement the CM-EA program Exclusion Criteria: * Only EAs that present with unstable conditions requiring intensive treatment, such as hospital interventions, will be excluded from the sample. Examples of these conditions include participant reports of active suicidal or homicidal intentions or requests for medically supervised detox services. 2. Peer Workers Inclusion Criteria: * Certified peer worker (aged 18+) willing to be trained in vocational/educational skill building and participate in research protocols with study-enrolled emerging adult clients. Exclusion Criteria: * None 3. Parent Coaches Inclusion Criteria: * Individual (18+) with a background in clinical work willing to be trained in Contingency Management for Emerging Adults (CM-EA) and participate in research protocols with study-enrolled parent clients. Exclusion Criteria: * None 4. .Payors/Providers of Recovery Services Inclusion Criteria: * Individual (18+) who works at an administrative level at an organization that provides or pays for recovery services that would potentially fund or otherwise support the implementation of Launch services willing to be interviewed. Exclusion Criteria: * None **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** tkdrazdowski@chestnut.org **Name:** Tess K Drazdowski, PhD **Phone:** 309-451-7755 **Role:** CONTACT #### Locations **Location 1:** **City:** Eugene **Contacts:** ***Contact 1:*** - **Email:** tkdrazdowski@chestnut.org - **Name:** Tess K Drazdowski, PhD - **Phone:** 309-451-7755 - **Role:** CONTACT ***Contact 2:*** - **Email:** ajsheidow@chestnut.org - **Name:** Ashli J Sheidow, PhD - **Role:** CONTACT ***Contact 3:*** - **Name:** Tess K Drazdowski, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Chestnut Health Systems **State:** Oregon **Zip:** 97401 #### Overall Officials **Official 1:** **Affiliation:** Chestnut Health Systems **Name:** Tess K Drazdowski, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Information on where the data will be available and how to access the data will be included in any publications and presentations that the study team authors using these data. The repositories (e.g., NAHDAP), HEAL Data Ecosystem, and funding sources will be acknowledged in any publications and presentations. Repositories such as the NAHDAP have policies and procedures in place that will provide data access to qualified researchers, fully consistent with NIH data sharing policies and applicable laws and regulations. **Description:** Attendance data, client satisfaction data, and EA outcomes data will be shared. Participants will be assigned a unique identifier to allow linking across data files. These data will be stored in an electronic file format (e.g., csv), accessible to standard analytic software (e.g., Excel, SAS) and will undergo formatting and quality assurances prior to sharing. Data dictionaries and codebooks, detailing variable-level information also will be shared. The PI agrees to deposit and maintain the data, and any secondary analysis of data prior to depositing data into the NAHDAP or similar repository. The PI understands that NAHDAP and similar repositories have data access policies and procedures consistent with NIH and the Helping End Addiction Long-term (HEAL) Initiative data sharing policies. HEAL data stewards will ensure that data are available to the HEAL Ecosystem after deposit. **Info Types:** - STUDY_PROTOCOL - ICF **IPD Sharing:** YES **Time Frame:** Data will be shared upon acceptance of the data for publication or within six months after the completion of the 6-month follow-up assessments, whichever is earlier. ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414980 **Brief Title:** Smell Memory Method for Patients Before Surgery **Official Title:** Examining the Effect of the Suggestion Given to Patients With the Olfactory Memory Method Before the Surgical Operation on the Vital Signs and Systemic Evaluation Scoring During Awakening. #### Organization Study ID Info **ID:** B.30.2.ATA.0.01.00/688 #### Organization **Class:** OTHER **Full Name:** Ataturk University ### Status Module #### Completion Date **Date:** 2024-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ataturk University #### Responsible Party **Investigator Affiliation:** Ataturk University **Investigator Full Name:** Mükremin Taşkın **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The research is planned as a randomized controlled experimental at Erzurum Atatürk University Health Application and Research Center. The population of the research will include patients who come to the General Surgery Gastroenterology service for laparoscopic cholecystectomy between the specified dates and who meet the criteria for inclusion in the study. In this research, 30 experimental and 30 control group patients will be included in the study in order to perform parametric tests. The data of the research were prepared by the researcher using the literature and similar studies after obtaining ethics committee approval and written permission from the institution where the research would be conducted. "FR.3- Alertness and Sedation Observer Assessment Scale (OAA/S)" and Modified Aldrete Scoring, Awake and Sedation Observer Assessment Scale and "FR.4- MAS and OAA/S Scores Time-Dependent", which includes the Patient's Vital Signs, are used to evaluate the patient's condition. Patients determined by the "Change Table" will be collected by observing them before and after surgery. In the research; In order to more easily overcome the anxiety and confusion that patients who have undergone surgical operations experience during the orientation process while waking up after the case, the patient will be given suggestions regarding the post-anesthesia waking period by testing the menthol smell in the preoperative period. When the patient hears the menthol scent applied during postoperative awakening; It is intended for the patient to remember that his surgery is over, that he needs to wake up and that the medical staff is waiting for him to wake up. In this way, it is thought that the patient's anxiety and complexity during the postoperative awakening period will be eliminated, the patient's vital signs will remain at an optimum level, and a more comfortable reanimation will occur. ### Conditions Module **Conditions:** - Surgery - Gallbladder - Smell ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 34 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** On the day of the operation, patients will be given a menthol scent before the surgery. Data collection forms will be applied to the experimental group at specified intervals on the day of operation, at the clinic exit, before surgery, after surgery and in the recovery room (PACU). The day after the operation, a final interview will be held with the experimental group patients and questions will be asked about their experiences during the post-operative awakening process and these will be recorded. **Intervention Names:** - Behavioral: Experimental **Label:** Experimental **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** In the control group, which did not undergo any intervention, at the clinic exit on the day of the operation, vital values (pulse, blood pressure) were recorded at preoperative, postoperative and recovery room (PACU) intervals (Unit entrance, 5th minute, 10th minute, 15th minute and 20th minute). , body temperature, blood pressure and SpO2) will be taken. At the same time, the Modified Aldrete Score (MAS) and the Alertness and Sedation Observer Rating Scale (OSS/S) will be independently evaluated and recorded by the researcher. **Label:** Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental **Description:** The effect of suggestion given to patients with the olfactory memory method before the surgical operation on vital signs and systemic evaluation scoring during awakening. **Name:** Experimental **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The Aldrete score was first described in 1970 by Dr Antonio Aldrete as an analogue of Apgar scoring. This scoring system examines muscle activity, respiration, blood pressure, consciousness and skin color, with each given 0, 1 or 2 points, giving a maximum score of 10. Patients with a total score of 8 or above can be easily sent from the recovery room. The Modified Aldrete Scoring has become widely accepted in assessing postanesthetic recovery. It has been widely used in many postanesthesia care units41 since its description. When the Modified Aldrete Score is calculated as 9 or above, it indicates that patients are adequately prepared for transfer from the postanesthesia care unit to the service. Today, organizations such as the Canadian Association of Anesthesiologists, the Joint Commission on Accreditation of Healthcare Organizations, and the Ontario Perianesthesia Nurses Association recommend the use of the Modified Aldrete Scoring. **Measure:** Modified Aldrete Score **Time Frame:** 1 day #### Secondary Outcomes **Description:** The Alertness and Sedation Observer Assessment Scale (OAA/S) is a scoring system used to evaluate the alertness state in patients. In today's anesthesia practices, the OAA/S score is widely used to evaluate the level of consciousness suppression of hypnotic drugs and the alertness of patients. The OAA/S score was first introduced by Chernik et al. in 1990. This scoring system is an evaluation based on scoring the patient's response between 0-5. The patient's reaction status is examined, starting with calling the patient in a normal tone of voice, progressing to light poking and shaking, and if necessary, giving painful stimuli (squeezing the trapezius). Patients with scores of 5-4-3 are considered responsive, while patients with scores of 0-1 are considered unresponsive. Patients with scores between 2 and 3 are considered to have loss of consciousness. **Measure:** Observer Rating of Alertness and Sedayson Scale (OSS/S) **Time Frame:** 1 day ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Students who do not have communication barriers or hearing, speaking or perception problems will participate in the research. * Those who are over 18 years of age and under 80 years of age, * Will participate in the study voluntarily, * Those who will undergo elective laparoscopic cholecystectomy surgery, * Operation duration of 1 hour or more, * General anesthesia will be applied, * Patients without chronic loss of smell Exclusion Criteria: * Those who do not accept to work, * Having problems in smelling, * Emergency surgeries that occur outside the daily surgery list **Healthy Volunteers:** True **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Erzurum **Contacts:** ***Contact 1:*** - **Email:** mukremin.taskin@atauni.edu.tr - **Name:** Mükremin TAŞKIN - **Phone:** +905395150257 - **Role:** CONTACT **Country:** Turkey **Facility:** Mükremin Taşın **Status:** RECRUITING ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11591 - Name: Menthol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414967 **Acronym:** MUSIC-HD **Brief Title:** Study to Evaluate Music Therapy on Irritability and Impulsivity in Patients With Huntington's Disease (MUSIC-HD) **Official Title:** Pilot Study Evaluating the Benefits of Music Therapy Combined With Conventional Treatment on Irritability and Impulsivity in Patients With Huntington's Disease (MUSIC-HD) #### Organization Study ID Info **ID:** MUSIC-HD #### Organization **Class:** OTHER **Full Name:** Poitiers University Hospital ### Status Module #### Completion Date **Date:** 2026-05-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-11-20 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Poitiers University Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The study is an open-label clinical trial evaluating whether music therapy combined with conventional management reduces irritability and impulsivity in 15 patients with early-stage Huntington's disease. This pilot study aims to show the interest of alternative non-pharmacological measures such as a digital music therapy tool, adapted to an audience of Huntington's patients, to help manage the psychobehavioral symptoms frequently observed in this affection, and to avoid breakdowns due to caregiver exhaustion. **Detailed Description:** The participants will be recruited at the Clinical Investigation Center (CIC) of the University Hospital of Poitiers and will receive music therapy for 3 months. After the start of the musical intervention, 3 visits (at 1 month, 3 months and 6 months) will be performed by practitioners, nurses and neuropsychologist at the CIC. Participants will answer questionnaires : irritability (BITe and PBA-s sub-score), impulsivity (UPPS-P and Delay discounting task), anxiety (STAI-Y and HAM-A), and quality of life: H-QoL-I. Caregivers will be asked to rate the patient's irritability and anxiety using a Lickert scale from 0 to 10, and the patient's impulsivity with the ISDC. ### Conditions Module **Conditions:** - Huntington Disease **Keywords:** - Music Therapy - Irritability - Impulsivity ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 15 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The rythm of the music sessions will be 1 per week in the first month and every 15 days in the second and third month. **Intervention Names:** - Other: Music Intervention **Label:** Music Intervention **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Music Intervention **Description:** Music therapy carried out with Music Care **Name:** Music Intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Score of The brief Irritability Test (BITe). It consists of 5 questions, each rated on likert-type scale with 6 responses options, each question scores to 1 to 6. Lower score means a better outcome. **Measure:** Describe evolution of irritability in patients with Huntington's disease after 3 months of music therapy combined with conventional management **Time Frame:** Month 3 #### Secondary Outcomes **Description:** Score of The brief Irritability Test (BITe). It consists of 5 questions, each rated on likert-type scale with 1-6 responses options. Lower score means a better outcome. Score of Problem Behavior Assessment-short version (PBA-s). It consist of 4 questions, each rated on likert-type scale with 5 responses options, each question scores to 0 to 4. Lower score means a better outcome. **Measure:** Describe evolution of irritability in patients with Huntington's disease with music therapy combined with conventional management **Time Frame:** Month [1;3;6] **Description:** UPPS (Impulsive Behavior Scale). It consists of 20 questions, each rated on likert-type scale with 4 response options. Lower scores mean a better outcome. Delay discounting task. ISDC (Inventary of Comportement Dyexecutif Syndrom). It consists of 8 questions, each rated on likert-type scale with 3-5 response options. Lower scores means a better outcome. **Measure:** Describe evolution of impulsivity **Time Frame:** Month [1;3;6] **Description:** STAI-Y (Form-Y of the State-Trait Anxiety Inventory) score. It consist of 20-item scales providing separate measures of state and trait anxiety (S-Anxiety and T-Anxiety, respectively). On a 4-point Likert scale (1-4), a score equal to 4 indicates the presence of a higher level of anxiety. HAM-A (Hamilton Anxiety Rating Scale) score. It consist of 14 item-scale, each rated on likert-type scale with 4 response options. Lower scores mean a better outcome **Measure:** Describe evolution of Anxiety. **Time Frame:** Month [1;3;6] **Description:** H-QoL-I (Huntington Qualty of Life Instrument), It consist of 11 items scale, each rated on likert-type scale with 5 response options.Lower scores mean a better outcome. **Measure:** Describe evolution of the quality of life **Time Frame:** Month [3;6] **Description:** Number of music therapy sessions performed. **Measure:** Compliance with musical sessions **Time Frame:** Month [1;3] **Description:** A lickert scale from 0 to 10. Lower scores mean a better outcome. **Measure:** Describe caregivers feeling about the effect of music intervention on patient's irritability and anxiety **Time Frame:** Month [3;6] ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age \>= 18 years * Huntington disease genetically confirmed by the presence of at least 35 repeats of the CAG triplet in exon 1 of the HTT gene * UHDRS (Unified Huntington's disease Rating Scale) score \<= 5 with a diagnostic confidence score =4 * Absence of significant cognitive impairment MoCA \>=24 * Stable drug therapy in the 28 days prior inclusion and during the study * Without legal tutors or subordination * Affiliated to a health insurance system as required by the French law on biomedical research * Written informed consent for participation in the study Exclusion Criteria: * Inability to give free and informed consent for study participation * Significant hearing impairment * Participating to another study the day of enrollement * Persons benefiting from enhanced protection, i.e.persons deprived of their liberty by a judicial or administrative decision, adults under legal and finally patients in a vital emergency situation. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** isabelle.benatru@chu-poitiers.fr **Name:** Isabelle BENATRU, Dr **Phone:** 05 49 44 33 89 **Phone Ext:** +33 **Role:** CONTACT **Contact 2:** **Email:** claire.lafay-chebassier@chu-poitiers.fr **Name:** Claire LAFAY-CHEBASSIER, Dr **Phone:** 05 49 44 38 36 **Phone Ext:** +33 **Role:** CONTACT #### Locations **Location 1:** **City:** Poitiers **Contacts:** ***Contact 1:*** - **Name:** Isabelle BENATRU - **Role:** CONTACT **Country:** France **Facility:** CHU Poitiers / CIC **Status:** RECRUITING **Zip:** 86000 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001480 - Term: Basal Ganglia Diseases - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000003704 - Term: Dementia - ID: D000002819 - Term: Chorea - ID: D000020820 - Term: Dyskinesias - ID: D000009069 - Term: Movement Disorders - ID: D000020271 - Term: Heredodegenerative Disorders, Nervous System - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000003072 - Term: Cognition Disorders - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9875 - Name: Huntington Disease - Relevance: HIGH - As Found: Huntington's Disease - ID: M10220 - Name: Impulsive Behavior - Relevance: HIGH - As Found: Impulsivity - ID: M25603 - Name: Ganglion Cysts - Relevance: LOW - As Found: Unknown - ID: M16358 - Name: Synovial Cyst - Relevance: LOW - As Found: Unknown - ID: M4774 - Name: Basal Ganglia Diseases - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M6904 - Name: Dementia - Relevance: LOW - As Found: Unknown - ID: M6059 - Name: Chorea - Relevance: LOW - As Found: Unknown - ID: M22574 - Name: Dyskinesias - Relevance: LOW - As Found: Unknown - ID: M12029 - Name: Movement Disorders - Relevance: LOW - As Found: Unknown - ID: M22092 - Name: Heredodegenerative Disorders, Nervous System - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M6301 - Name: Cognition Disorders - Relevance: LOW - As Found: Unknown - ID: M21836 - Name: Neurocognitive Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: T2852 - Name: Huntington Disease - Relevance: HIGH - As Found: Huntington's Disease ### Condition Browse Module - Meshes - ID: D000006816 - Term: Huntington Disease - ID: D000007175 - Term: Impulsive Behavior ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414954 **Acronym:** SYNAPSE-MG **Brief Title:** Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis **Official Title:** A Phase 2b, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 3 Dose Levels of NMD670 Over 21 Days in Adult Patients With AChR/MuSK-Ab+ Myasthenia Gravis #### Organization Study ID Info **ID:** NMD670-02-0002 #### Organization **Class:** INDUSTRY **Full Name:** NMD Pharma A/S #### Secondary ID Infos **Domain:** EUCTR **ID:** 2023-507539-40 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2025-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** NMD Pharma A/S #### 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 Phase 2 proof-of-concept, dose range finding study aims to evaluate the safety and efficacy of 3 dose levels of NMD670 vs placebo in adult patients with MG with antibodies against AChR or MuSK, administered twice a day (BID) for 21 days. ### Conditions Module **Conditions:** - Myasthenia Gravis - Myasthenia Gravis, MuSK ### 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:** 84 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: NMD670 **Label:** NMD670 high dose **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: NMD670 **Label:** NMD670 mid dose **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Drug: NMD670 **Label:** NMD670 low dose **Type:** EXPERIMENTAL #### Arm Group 4 **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - NMD670 high dose - NMD670 low dose - NMD670 mid dose **Description:** Tablets taken twice a day for 21 days **Name:** NMD670 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Tablets taken twice a day for 21 days **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Scale goes from 0-36 and higher score indicates worse symptomatology **Measure:** Change from baseline to day 21 in QMG total score for NMD670 vs placebo **Time Frame:** Baseline to day 21 #### Secondary Outcomes **Description:** Scale goes from 0-24 and higher score indicates worse symptomatology **Measure:** Change from baseline to day 21 in MG-ADL total score for NMD670 vs placebo **Time Frame:** Baseline to day 21 **Description:** Scale goes from 0-50 and higher score indicate worse symptomatology **Measure:** Change from baseline to day 21 in MGC total score for NMD670 vs placebo **Time Frame:** Baseline to day 21 **Description:** Scale goes from 0-30 and higher score indicate worse quality of life **Measure:** Change from baseline to day 21 in MG-QOL15r for NMD670 vs placebo **Time Frame:** Baseline to day 21 **Description:** Scale goes from 8-40 and higher score indicate worse symptomalogy **Measure:** Change from baseline to day 21 in Neuro-QoL Fatigue Short Form **Time Frame:** Baseline to day 21 **Description:** Summarised per treatment **Measure:** Incidence of treatment emergent adverse event **Time Frame:** Over 21 days of dosing **Description:** Summarised per treatment **Measure:** Incidence of serious treatment emergent adverse events **Time Frame:** Over 21 days of dosing **Description:** Summarised per treatment **Measure:** Incidence of clinically significant abnormalities on physical examinations **Time Frame:** Over 21 days of dosing **Description:** Summarised per treatment **Measure:** Incidence of clinically significant abnormalities on safety laboratory parameters **Time Frame:** Over 21 days of dosing **Description:** Summarised per treatment **Measure:** Incidence of clinically significant vital signs abnormalities **Time Frame:** Over 21 days of dosing **Description:** Summarised per treatment **Measure:** Incidence of clinically significant ECG abnormalities **Time Frame:** Over 21 days of dosing **Description:** Summarised per treatment **Measure:** Incidence of Suicidal Ideation or Suicidal Behavior **Time Frame:** Over 21 days of dosing **Description:** Summarised per treatment **Measure:** Incidence of clinically significant abnormalities on opthalmological examinations **Time Frame:** From screening (day -28 to day -1) until follow up (day 28) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participant must be a male or female being 18 to 75 years (both included), at the time of signing the informed consent * Diagnosis of MG, MGFA class II, III or IV * Documented positive AChR or MuSK antibody test. * Participant must be able to swallow tablets * Body mass index between 18 and 35 kg/m2, inclusive, at screening, and with a minimum weight of 40 kg * Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies * Participant is capable of and has given signed informed consent Exclusion Criteria: * Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the patient's full participation in the study, pose any additional risk for the patient, or confound the assessment of the patient or outcome of the study * Participants with other significant clinical and/or laboratory safety findings that may interfere with the conduction or interpretation of the study * Participants that received treatment with an investigational medical product within 30 days (or 5 half-lives of the medication, whichever is longer) prior to Day 1 * Participants with history of poor compliance with relevant MG therapy * Female patients who plan to become pregnant during the study or are currently pregnant or breastfeeding **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** contact@nmdpharma.com **Name:** NMD Pharma A/S **Phone:** contact@nmdpharma.com **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000020879 - Term: Neuromuscular Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000010335 - Term: Pathologic Processes - ID: D000020361 - Term: Paraneoplastic Syndromes, Nervous System - ID: D000009423 - Term: Nervous System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000010257 - Term: Paraneoplastic Syndromes - ID: D000020274 - Term: Autoimmune Diseases of the Nervous System - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000020511 - Term: Neuromuscular Junction Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12112 - Name: Myasthenia Gravis - Relevance: HIGH - As Found: Myasthenia Gravis - ID: M20944 - Name: Muscle Weakness - Relevance: HIGH - As Found: Myasthenia - ID: M13204 - Name: Paresis - Relevance: LOW - As Found: Unknown - ID: M4554 - Name: Asthenia - Relevance: LOW - As Found: Unknown - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M22619 - Name: Neuromuscular Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M13170 - Name: Paraneoplastic Syndromes - Relevance: LOW - As Found: Unknown - ID: M22160 - Name: Paraneoplastic Syndromes, Nervous System - Relevance: LOW - As Found: Unknown - ID: M12367 - Name: Nervous System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M22094 - Name: Autoimmune Diseases of the Nervous System - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M22297 - Name: Neuromuscular Junction Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T3973 - Name: Myasthenia Gravis - Relevance: HIGH - As Found: Myasthenia Gravis ### Condition Browse Module - Meshes - ID: D000009157 - Term: Myasthenia Gravis - ID: D000018908 - Term: Muscle Weakness ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414941 **Brief Title:** The Effect of Dexmedetomidine and Esketamine Combined Infusion Quality of Sleep Undergoing Modified Radical Mastectomy **Official Title:** Dexmedetomidine Combined With Esketamine Effects the Quality of Sleep #### Organization Study ID Info **ID:** errtg555 #### Organization **Class:** OTHER **Full Name:** Anqing Municipal Hospital ### Status Module #### Completion Date **Date:** 2024-10-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-10-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Anqing Municipal Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** BACKGROUND: Some studies have revealed that intravenous dexmedetomidine and esketamine improve the quality of sleep after surgery. The investigators investigated whether co-administration dexmedetomidine and esketamine could better improve the the quality of sleep after modified radical mastectomy. METHODS: One hundred and five women with elective modified radical mastectomy were randomly divided into 3 groups: Patients in group D received dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until 20 min before the end of operation. Patients in group DE1 received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 2 µg/kg/min until 20 min before the end of operation, respectively. Patients in group DE2 received received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 4 µg/kg/min until 20 min before the end of operation, respectively. Primary outcome was the quality of sleep (PSQI) at the day after surgery and 1 day after surgery. The secondary outcomes included MAP, HR, postoperative VAS pain scores, side effects such as the incidence of postoperative nausea and vomiting, hallucination, as well as agitation, drowness, postoperative rescue analgesics and anti-emetics, recovery time, and extubation time. ### Conditions Module **Conditions:** - Dexmedetomidine Plus Esketamine Affect Postoperative Sleep Quality **Keywords:** - Esketamine - Sleep quality - Dexmedetomidine ### 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:** 105 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Dexmedetomidine infusion Patients received dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until 20 min before the end of operation **Intervention Names:** - Drug: Dexmedetomidine administration - Drug: Dexmedetomidine plus low-dose esketamine administration - Drug: Dexmedetomidine plus high-dose esketamine administration **Label:** Dexmedetomidine on sleep quality with radical mastectomy **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Dexmedetomidine and low-dose eskeamine combined infusion Patients received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 2 µg/kg/min until 20 min before the end of operation, respectively. **Intervention Names:** - Drug: Dexmedetomidine administration - Drug: Dexmedetomidine plus low-dose esketamine administration - Drug: Dexmedetomidine plus high-dose esketamine administration **Label:** Dexmedetomidine plus low-dose esketamine on sleep quality with radical mastectomy **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Dexmedetomidine and high-dose eskeamine combined infusion Patients received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 4 µg/kg/min until 20 min before the end of operation, respectively. **Intervention Names:** - Drug: Dexmedetomidine administration - Drug: Dexmedetomidine plus low-dose esketamine administration - Drug: Dexmedetomidine plus high-dose esketamine administration **Label:** Dexmedetomidine plus high- dose esketamine on sleep quality with radical mastectomy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Dexmedetomidine on sleep quality with radical mastectomy - Dexmedetomidine plus high- dose esketamine on sleep quality with radical mastectomy - Dexmedetomidine plus low-dose esketamine on sleep quality with radical mastectomy **Description:** atients received dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until 20 min before the end of operation **Name:** Dexmedetomidine administration **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Dexmedetomidine on sleep quality with radical mastectomy - Dexmedetomidine plus high- dose esketamine on sleep quality with radical mastectomy - Dexmedetomidine plus low-dose esketamine on sleep quality with radical mastectomy **Description:** Patients received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 2 µg/kg/min until 20 min before the end of operation, respectively. **Name:** Dexmedetomidine plus low-dose esketamine administration **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Dexmedetomidine on sleep quality with radical mastectomy - Dexmedetomidine plus high- dose esketamine on sleep quality with radical mastectomy - Dexmedetomidine plus low-dose esketamine on sleep quality with radical mastectomy **Description:** Patients received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 4 µg/kg/min until 20 min before the end of operation, respectively. **Name:** Dexmedetomidine plus high-dose esketamine administration **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Our primary outcome was Pittsburgh sleep quality index (PSQI) at the day after surgery **Measure:** Pittsburgh sleep quality index (PSQI) **Time Frame:** the day after surgery #### Secondary Outcomes **Description:** Our primary outcome was Pittsburgh sleep quality index (PSQI) on 1 day after surgery **Measure:** Pittsburgh sleep quality index (PSQI) **Time Frame:** 1 day after surgery **Description:** Our primary outcome was pain visual analogue scale scores **Measure:** pain visual analogue scale scores **Time Frame:** The first 48 hours after operation ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * American Society of Anesthesiologists (ASA) physical status Ⅰ- Ⅱ * Scheduled for elective modified radical mastectomy Exclusion Criteria: * Severe respiratory disease * Renal or hepatic insufficiency * History of preoperative psychiatric * Preoperative bradycardia * Preoperative atrioventricular block * Preoperative hypertension * BMI\>30 **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 25 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** errtg555@163.com **Name:** Xu si qi, Doctor **Phone:** 13865192106 **Role:** CONTACT #### Locations **Location 1:** **City:** Anqing **Country:** China **Facility:** Department of Anqing Hospital Anesthesiology **State:** Anhui **Status:** RECRUITING **Zip:** 246003 ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000006993 - Term: Hypnotics and Sedatives - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018712 - Term: Analgesics, Non-Narcotic - ID: D000000700 - Term: Analgesics - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000058647 - Term: Adrenergic alpha-2 Receptor Agonists - 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: D000000928 - Term: Antidepressive Agents - ID: D000011619 - Term: Psychotropic Drugs ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Analg - Name: Analgesics - Abbrev: PsychDr - Name: Psychotropic Drugs ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M22662 - Name: Dexmedetomidine - Relevance: HIGH - As Found: Twice daily - ID: M271980 - Name: Esketamine - Relevance: HIGH - As Found: Days per week - ID: M10043 - Name: Hypnotics and Sedatives - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M20786 - Name: Analgesics, Non-Narcotic - Relevance: LOW - As Found: Unknown - ID: 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: M4247 - Name: Antidepressive Agents - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000020927 - Term: Dexmedetomidine - ID: C000629870 - Term: Esketamine ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414928 **Brief Title:** Prognostic Model Heart Failure **Official Title:** In-hospital & 30-day Prognostication of Acute Heart Failure Patients by Comparing 4 Validated Scores in Patients Presenting to the Emergency Department of Cardiac Tertiary Care Hospital, Karachi- Pakistan #### Organization Study ID Info **ID:** IRB-63/2023 #### Organization **Class:** OTHER **Full Name:** National Institute of Cardiovascular Diseases, Pakistan ### Status Module #### Completion Date **Date:** 2026-06-14 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-02-14 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-14 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** National Institute of Cardiovascular Diseases, Pakistan #### Responsible Party **Investigator Affiliation:** National Institute of Cardiovascular Diseases, Pakistan **Investigator Full Name:** Madiha Fatima **Investigator Title:** Senior Registrar Emergency **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study aims to determine the prognosis of heart failure in our population by using multiple validated risk scores and to evaluate the strengths of these scores in assessing prognosis with better discrimination. **Detailed Description:** After fulfilling the eligibility criteria, informed consent will be obtained from all the patients regarding using data for research while maintaining anonymity. All the included patients will be interviewed by the assigned physician to complete the detailed questionnaire, including patient demographics, risk factors, and validated questionnaires including the Acute Decompensated Heart Failure National Registry (ADHERE), The Get With The Guideline-Heart Failure (GWTG-HF) Risk Score, the Ottawa Heart Failure Risk Scale (OHFRS), and EHMRG30-ST score. All the patients will be followed after 30 days, and survival status will be obtained. The AUC of the GWTG-HF risk score for all-cause death was 0.687 (95% CI, 0.649-0.725) \[18\], at 95% confidence interval, ±3% margin of error, the sample size was calculated to be n=626 patients. The calculated sample size was inflated by a factor of 1.5 for the design effect; hence, the sample size for the study will be N=939. For data verification, 10% of the data will be cross-checked with the source document (Patient file). ### Conditions Module **Conditions:** - Heart Failure Acute ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 1000 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 30 Days ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Consecutive patients presented at Emergency Departement with Acute Heart Failure **Name:** Acute Heart Failure **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Factors affecting in-hospital prognosis of patients with acute heart failure presented at Emergency of a tertiary care hospital **Measure:** In-Hospital Prognosis **Time Frame:** From admission till discharge/death **Description:** Factors affecting the 30-day prognosis of patients with acute heart failure either via telephonic contact or re-admission or via OPD. **Measure:** 30-day Prognosis **Time Frame:** From day of admission of last visit till 30 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients of age \> 18 years or more * Either gender * Patients visited the emergency department at NICVD, Karachi * Newly/Already diagnosed with Heart Failure * Giving informed consent * Who can be followed in 30 days via Telephone or in OPD Exclusion Criteria: * Patients of age \<18 years * Patients who do not give consent * Patients who are mentally handicapped due to any neurological or psychiatric illness (excluding depression/anxiety) **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients presented at the Emergency Department with signs and symptoms of Acute Heart Failure who are fulfilling the eligibility criteria will be enrolled. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** madihafatima89@hotmail.com **Name:** Madiha Fatima, MBBS, FCPS **Phone:** +923452325663 **Role:** CONTACT **Contact 2:** **Email:** rajeshnarsoolal@gmail.com **Name:** Rajesh Kumar, MBBS, FCPS **Phone:** +923337306090 **Role:** CONTACT #### Locations **Location 1:** **City:** Karachi **Contacts:** ***Contact 1:*** - **Email:** madihafatima89@hotmail.com - **Name:** Madiha Fatima, MBBS, FCPS - **Phone:** +923452325663 - **Role:** CONTACT ***Contact 2:*** - **Email:** rajeshnarsoolal@gmail.com - **Name:** Rajesh Kumar, MBBS, FCPS - **Phone:** +923337306090 - **Role:** CONTACT **Country:** Pakistan **Facility:** National Institute of Cardiovascular Diseases **State:** Sindh **Status:** RECRUITING **Zip:** 75510 #### Overall Officials **Official 1:** **Affiliation:** National Institute of Cardiovascular Diseases **Name:** Madiha Fatima, MBBS, FCPS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** The Hospital Medical Record number will be used as the patient identifier. **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: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M7796 - Name: Emergencies - Relevance: LOW - As Found: Unknown - ID: M9421 - Name: Heart Failure - Relevance: HIGH - As Found: Heart Failure - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006333 - Term: Heart Failure ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414915 **Brief Title:** Surufatinib Combined With Tislelizumab in Advanced Lung Cancer With Neuroendocrine Differentiation **Official Title:** A Single-arm, Open, Single-center, Prospective and Exploratory Clinical Study of Surufatinib Combined With Tislelizumab in the Treatment of Advanced Lung Cancer With Neuroendocrine Differentiation #### Organization Study ID Info **ID:** HMPL-012-SPRING-NEN110 #### Organization **Class:** OTHER **Full Name:** National Cancer Center, China ### Status Module #### Completion Date **Date:** 2027-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** National Cancer Center, China #### Responsible Party **Investigator Affiliation:** National Cancer Center, China **Investigator Full Name:** Puyuan Xing **Investigator Title:** Chief Medical Officer **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Currently, there are no standard treatment and relevant exploration for NSCLC patients with NED. The study aims to explore the efficacy and safety of surufatinib combined with tislelizumab in the treatment of NSCLC with NED, in order to provide a new treatment option for NSCLC patients with NED. **Detailed Description:** This is a single-arm, open, single-center, prospective and exploratory clinical study. We planned to enroll 29 patients who would receive surufatinib plus tislelizumab until disease progression, intolerance, or withdrawal of consent. The study aims to explore the efficacy and safety of surufatinib combined with tislelizumab in the treatment of NSCLC with NED, in order to provide a new treatment option for NSCLC patients with NED. ### Conditions Module **Conditions:** - NSCLC **Keywords:** - NSCLC - neuroendocrine differentiation - Surufatinib - Tislelizumab ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 29 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Surufatinib - Drug: Tislelizumab **Label:** Surufatinib + tislelizumab **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Surufatinib + tislelizumab **Description:** 250 mg, po, qd, q3w **Name:** Surufatinib **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Surufatinib + tislelizumab **Description:** 200mg, iv, q3w **Name:** Tislelizumab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** time from first-dose to the first documented disease progression or death **Measure:** Progression-Free Survival (PFS) **Time Frame:** approximately 1 years #### Secondary Outcomes **Description:** the proportion of patients with complete response or partial response, using RESIST v1.1 **Measure:** Objective response rate (ORR) **Time Frame:** approximately 1 years **Description:** the proportion of patients with complete response, partial response or stable disease, using RESIST v1.1 **Measure:** Disease Control Rate (DCR) **Time Frame:** approximately 1 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Histopathologically confirmed locally advanced or metastatic unresectable lung cancer (IIIB-IV) with an abnormal NED or NE phenotype (without neuroendocrine morphologic features and positive immunohistochemical expression of at least one neuroendocrine marker (CD56, CgA, Syn)); * Have at least one measurable lesion according to RECIST v1.1; * ECOG performance status: 0-1; * Patients who were deemed by the investigator to be eligible for first-line single-agent immunotherapy or who progressed on first-line standard therapy; * Urine protein \< ++ . If Urine protein ≥ ++ ,the amount of urine protein in 24 hours ≤1.0g; * Expected survival time \> 3 months; Exclusion Criteria: * Pulmonary neuroendocrine tumors (typical carcinoid, atypical carcinoid, small cell carcinoma, large cell neuroendocrine carcinoma); * Prior anti-VEGF/VEGFR-targeted therapy or anti-PD (L)1 antibody; * Have uncontrolled hypertension, defined as systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mm Hg, while under anti-hypertension treatment; * Patients with active ulcer, intestinal perforation and intestinal obstruction; * With active bleeding or bleeding tendency; * Severe history of cardiovascular and cerebrovascular diseases; * Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** xingpuyuan@cicams.ac.cn **Name:** Puyuan Xing, Doctorate **Phone:** +86-10-87787421 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Department of Medical Oncology, National Cancer Center, China **Name:** Puyuan Xing, Doctorate **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 ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M137899 - Name: Tislelizumab - Relevance: HIGH - As Found: Meet - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000707970 - Term: Tislelizumab ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414902 **Brief Title:** 18F-AraG PET/CT as a Non-Invasive Imaging Biomarker for Chemoradiation Treatment Response in Esophageal Cancer **Official Title:** 18F-AraG PET/CT as a Non-Invasive Imaging Biomarker for Chemoradiation Treatment Response in Esophageal Cancer #### Organization Study ID Info **ID:** 2023-0858 #### Organization **Class:** OTHER **Full Name:** M.D. Anderson Cancer Center #### Secondary ID Infos **Domain:** NCI-CTRP Clinical Registry **ID:** NCI-2024-04295 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2027-10-01 **Type:** ESTIMATED #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-10-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-11-29 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** M.D. Anderson Cancer Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** To learn if 18F-FAraG PET scans can find tumors in participants with esophageal cancer and predict a participant's response to treatment. **Detailed Description:** Primary Objectives * Evaluate the ability of 18F-FAraG PET imaging to detect tumors in participants with esophageal cancer; * Evaluate 18F-FAraG PET as a predictor of pathologic complete response Secondary Objectives * Evaluate the correlation of 18F-FAraG PET with clinical characteristics * Evaluate the correlation of 18F-FAraG PET with scRNA-seq data * Evaluate tissue and blood biomarkers as predictors of treatment response and disease recurrence * Evaluate functional imaging with 18F-FAraG PET and tissue and blood biomarkers as predictors of overall survival and disease-free survival * Compare 18F-FAraG PET SUV update to the change in standard 18FDG-PET SUV parameters before and after chemoradiation. ### Conditions Module **Conditions:** - Esophageal Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants found to be eligible to take part in this study, participant will have a 18F-FAraG PET scan as described below. Before you start treatment, you will have standard-of-care imaging and then undergo the research 18F-FAraG PET scan. About 20 minutes before the injection of the 18F-FAraG imaging tracer, you will drink two 8-ounce bottles of water to help clear the imaging tracer from your kidneys. **Intervention Names:** - Drug: ArabinoFuranosylGuanine [18F]F-AraG **Label:** 18F-FAraG PET **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 18F-FAraG PET **Description:** Given by IV **Name:** ArabinoFuranosylGuanine [18F]F-AraG **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 **Measure:** Safety and adverse events (AEs) **Time Frame:** Through study completion; an average of 1 year. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Participants must be ≥18 years of age 2. Participants with locally advanced esophageal cancer 3. Participants with untreated documented carcinoma of the esophagus that is \> 2 cm in patients who are going to receive systemic therapy concurrently with radiation as primary therapy are eligible 4. Ability to provide written informed consent in accordance with institutional policies 5. Female participants of childbearing potential must have a negative serum or urine pregnancy test within 1 week of the proposed investigational PET/CT scan(s) prior to injection of the investigational radiopharmaceutical 6. The effects of 18F-FAraG PET on the developing human fetus are unknown. For this reason and because 18F-FAraG PET agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following: * Postmenopausal (no menses in greater than or equal to 12 consecutive months). * History of hysterectomy or bilateral salpingo-oophorectomy. * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy). * History of bilateral tubal ligation or another surgical sterilization procedure. 7. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Exclusion Criteria: 1. Body weight ≥400 pounds or body habitus or disability that will not permit the imaging protocol to be performed 2. Pregnant or lactating females - Pregnant women are excluded from this study because 18F-FAraG PET agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with \[Agent\], breastfeeding should be discontinued if the mother is treated with \[Agent\]. These potential risks may also apply to other agents used in this study. 3. History of allergic reaction to intravenous contrast 4. eGFR\<40 within 1 month prior to receiving 8F-FAraG **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** shlin@mdanderson.org **Name:** Steven Lin, MD **Phone:** (713) 563-8490 **Role:** CONTACT #### Locations **Location 1:** **City:** Houston **Contacts:** ***Contact 1:*** - **Email:** shlin@mdanderson.org - **Name:** Steven Lin, MD - **Phone:** 713-563-8490 - **Role:** CONTACT ***Contact 2:*** - **Name:** Steven Lin, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** MD Anderson Cancer Center **State:** Texas **Zip:** 77030 #### Overall Officials **Official 1:** **Affiliation:** M.D. Anderson Cancer Center **Name:** Steven Lin, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### See Also Links **Label:** MD Anderson Cancer Center **URL:** http://www.mdanderson.org ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000004935 - Term: Esophageal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M8088 - Name: Esophageal Neoplasms - Relevance: HIGH - As Found: Esophageal Cancer - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8085 - Name: Esophageal Diseases - Relevance: LOW - As Found: Unknown - ID: T2141 - Name: Esophageal Cancer - Relevance: HIGH - As Found: Esophageal Cancer ### Condition Browse Module - Meshes - ID: D000004938 - Term: Esophageal Neoplasms ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414889 **Brief Title:** Protocol Title: Safety and Feasibility of Autologous CD34+ Hematopoietic Stem Cells Mobilization and Apheresis in Participants With RUNX1 Familial Platelet Disorder **Official Title:** Protocol Title: Safety and Feasibility of Autologous CD34+ Hematopoietic Stem Cells Mobilization and Apheresis in Participants With RUNX1 Familial Platelet Disorder #### Organization Study ID Info **ID:** 2023-0799 #### Organization **Class:** OTHER **Full Name:** M.D. Anderson Cancer Center #### Secondary ID Infos **Domain:** NCI-CTRP Clinical Registry **ID:** NCI-2024-04300 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2027-06-30 **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:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** RUNX1 Foundation #### Lead Sponsor **Class:** OTHER **Name:** M.D. Anderson Cancer Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** To evaluate the safety and feasibility of collecting hematopoietic stem cells (HSC) in participants with RUNX1-FPD. **Detailed Description:** Primary Objective: - To evaluate the safety of harvesting HSCs in participants with RUNX1 FPD Secondary Objective - To evaluate the feasibility and other relevant information of collecting HSCs from participants with RUNX1 FPD ### Conditions Module **Conditions:** - RUNX1 Familial Platelet Disorder ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 4 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** On Days 1-5, participants will receive a Granulocyte colony-stimulating factor (G-CSF), such as filgrastim, as an injection or by vein over about 5 minutes. If the study doctor thinks it is needed, participants will also receive plerixafor as an injection under the skin on Day 5 (and 6, if you have 2 days of apheresis). **Intervention Names:** - Drug: G-CSF (filgrastim or biosimilar) - Procedure: Apheresis - Drug: Plerixafor **Label:** Autologous CD34+ Hematopoietic Stem Cells Mobilization and Apheresis **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Autologous CD34+ Hematopoietic Stem Cells Mobilization and Apheresis **Description:** Given by IV or SC **Name:** G-CSF (filgrastim or biosimilar) **Other Names:** - FILGRASTIM SD/01 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Autologous CD34+ Hematopoietic Stem Cells Mobilization and Apheresis **Description:** Given by procedure **Name:** Apheresis **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Autologous CD34+ Hematopoietic Stem Cells Mobilization and Apheresis **Description:** Given by IV **Name:** Plerixafor **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 **Measure:** Safety and adverse events (AEs) **Time Frame:** Through study completion; an average of 1 year. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Participants who meet all of the following criteria are eligible to be included in the study: 1. Are aged ≥ 18 to 75 years a. Once a favorable review of safety has been completed by the SMC in 3 participants aged ≥ 18 years, the study will be opened to participants aged ≥ 12 years. 2. Are willing and able to provide informed consent, as appropriate (either directly or through a legally authorized representative \[LAR\]), as described in Appendix 1, Section 13.1 3. Have a confirmed diagnosis of RUNX1 FPD, verified by a Clinical Laboratory Improvement Amendments (CLIA)-certified genetic sequencing report. 4. Clearance by apheresis team to proceed 5. Have systolic blood pressure ≤ 170 mm Hg and diastolic blood pressure ≤ 95 mmHg 6. Are eligible for HSCT per institution requirements 7. Have a Lansky (age \< 16 years)/Karnofsky performance status of ≥ 70 (see Appendix 2, Section 13.2). 8. Are willing and able to comply with protocol-defined contraceptive requirements (see Appendix 3 Section 13.3) 9. Have a platelet count ≥ 50,000/μL for initiation of apheresis, assessed within 24 hours prior to the procedure, or, if \< 50,000/μL are administered platelets on the day of the collection a. If the apheresis team decides that a central venous catheter (CVC) is to be placed, platelet count should be ≥ 50,000 prior to catheter placement. 10. Have hemoglobin ≥ 7.5 g/dL as assessed within 24 hours prior to the procedure Exclusion Criteria: Participants who meet any of the following criteria are excluded from the study: 1. Participants with cognitive impairments and/or any serious unstable pre-existing medical condition or psychiatric disorder that can interfere with safety or with obtaining informed consent or compliance with study procedures. 2. Have uncontrolled bleeding 3. Are using supplemental oxygen 4. Have known severe splenomegaly (≥ 20 cm) 5. Have a diagnosis of MDS or hematologic malignancies, as defined by WHO hematolymphoid tumor classification fifth edition (Khourey et al 2022) hematolymphoid tumor classification fifth edition (Khourey et al 2022) 6. Have recent prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ Note: Cancer treated with curative intent \< 5 years previously may be allowed following approval from the study investigator. Cancer treated with curative intent \> 5 years previously is allowed. 7. Have any prior or current myeloproliferative or a significant coagulation or immunodeficiency disorder 8. Have advanced liver disease, defined as any of the following: 1. Persistent aspartate transaminase, alanine transaminase, or direct bilirubin value \> 5× the upper limit of normal (ULN) at screening 2. Screening prothrombin time (PT) or partial thromboplastin time (PTT) \> 1.5× ULN 9. Have had prior HSCT or gene therapy 10. Have history of concomitant sickle cell disease 11. Have been treated with an investigational drug within 30 days of screening or 5 half-lives (whichever is longer) 12. Have a positive test result for HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) at screening 1. Participants with positive hepatitis B core antibody (HbcAb) and/or hepatitis B-e antibody (HbeAb) are eligible provided viral load is negative by quantitative polymerase chain reaction (qPCR). 2. Participants who are positive for anti-hepatitis C antibody are eligible as long as they have a negative HCV viral load by qPCR. 13. Have a positive infectious disease panel at screening for human T-lymphotropic virus 1 or 2 (HTLV-1 and HTLV-2), or syphilis (rapid plasma 24 reagin \[RPR\]) 14. Have clinically significant and active bacterial, viral, fungal, or parasitic infection at screening 15. Have a white blood cell (WBC) count \< 2 × 109/L 16. Have a left ventricular ejection fraction \< 45% 17. Have a screening estimated glomerular filtration rate \< 60 mL/min/1.73 m2 18. Have a diagnosis of a significant psychiatric disorder that could seriously impede the ability to participate in the study 19. For women of childbearing potential: are pregnant or breastfeeding or lack adequate contraception 20. Are unable to comply with the study procedures, as assessed by the investigator **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:** cmhosing@mdanderson.org **Name:** Chitra Hosing, MD **Phone:** (713) 745-3219 **Role:** CONTACT #### Locations **Location 1:** **City:** Houston **Contacts:** ***Contact 1:*** - **Email:** cmhosing@mdanderson.org - **Name:** Chitra Hosing, MD - **Phone:** 713-745-3219 - **Role:** CONTACT ***Contact 2:*** - **Name:** Chitra Hosing, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** MD Anderson Cancer Center **State:** Texas **Status:** RECRUITING **Zip:** 77030 #### Overall Officials **Official 1:** **Affiliation:** M.D. Anderson Cancer Center **Name:** Chitra Hosing **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### See Also Links **Label:** MD Anderson Cancer Center **URL:** http://www.mdanderson.org ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006402 - Term: Hematologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5072 - Name: Blood Platelet Disorders - Relevance: HIGH - As Found: Platelet Disorder - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001791 - Term: Blood Platelet Disorders ### Intervention Browse Module - Ancestors - ID: D000000276 - Term: Adjuvants, Immunologic - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000019380 - Term: Anti-HIV Agents - ID: D000044966 - Term: Anti-Retroviral Agents - ID: D000000998 - Term: Antiviral Agents - ID: D000000890 - Term: Anti-Infective Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M340828 - Name: Plerixafor - Relevance: HIGH - As Found: Commitment - ID: M1945 - Name: Lenograstim - Relevance: HIGH - As Found: Effectiveness - ID: M3628 - Name: Adjuvants, Immunologic - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M21350 - Name: Anti-HIV Agents - Relevance: LOW - As Found: Unknown - ID: M25428 - Name: Anti-Retroviral Agents - Relevance: LOW - As Found: Unknown - ID: M4314 - Name: Antiviral Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000088327 - Term: Plerixafor - ID: D000078224 - Term: Lenograstim ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414876 **Brief Title:** Title: Urinary Oxytocin Levels in Children Receiving Animal-Assisted Therapy **Official Title:** Title: Urinary Oxytocin Levels in Children Receiving Animal-Assisted Therapy #### Organization Study ID Info **ID:** UOLinCRAAT_Uppsala University #### Organization **Class:** OTHER **Full Name:** Uppsala University ### Status Module #### Completion Date **Date:** 2017-05-24 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-05-24 **Type:** ACTUAL #### Start Date **Date:** 2016-02-02 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Uppsala University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** There has been growing interest in animal-assisted therapy (AAT) in recent decades due to increasing reports indicating its health benefits for adult patients. These benefits are partly attributed to changes, usually increased levels of the neuropeptide oxytocin. Aim: To investigate changes in oxytocin levels in hospitalized children during animal-assisted therapy sessions with a certified hospital dog. Method: Urine samples were collected from 35 hospitalized children (3-17 years) before and after each participant had a session with the hospital dog. Oxytocin levels were analysed with an acetylcholinesterase (AChE) competitive enzyme-linked immunosorbent assay (ELISA). Creatinine levels were measured to determine the subject's fluid intake and then divided by the hormonal concentration (uOT pg/mg). ### Conditions Module **Conditions:** - Animal Assisted Therapy **Keywords:** - Children - Hospital - Oxytocin ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: Hospital dog **Label:** The children played with the hospital dog and then by themselves. **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Behavioral: Hospital dog **Label:** The children played by themselves and then with the hospital dog. **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - The children played by themselves and then with the hospital dog. - The children played with the hospital dog and then by themselves. **Description:** The hospital dog always has a well educated dog instructor beside. **Name:** Hospital dog **Other Names:** - The children played with the hospital dog in about 40 minutes. **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Concentration of oxytocin (pg/mg) in urine samples measured by ELISA. **Measure:** Change in oxytocin levels **Time Frame:** Day of enrollment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Hospitalized children Exclusion Criteria: * Multiresistent bacteria * Immunosuppressed * Large burns **Maximum Age:** 17 Years **Minimum Age:** 3 Years **Sex:** ALL **Standard Ages:** - CHILD ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M13041 - Name: Oxytocin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414863 **Brief Title:** Effects of Invisalign Palatal Expander System **Official Title:** Treatment Effects of Invisalign Palatal Expander System and Hyrax Palatal Expander - A Randomized Controlled Trial #### Organization Study ID Info **ID:** 2024-43 #### Organization **Class:** OTHER **Full Name:** University of the Pacific ### Status Module #### Completion Date **Date:** 2034-05-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2028-05-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-10 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of the Pacific #### Responsible Party **Investigator Affiliation:** University of the Pacific **Investigator Full Name:** Heeyeon Suh **Investigator Title:** Assistant professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True ### Description Module **Brief Summary:** The aim of this study is to evaluate the effectiveness of Invisalign Palatal Expander system ingrowing patients. This study compares the treatment outcomes of Invisalign Palatal Expander system to conventional treatments through randomized controlled trial. ### Conditions Module **Conditions:** - Palatal Expansion Technique ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Invisalign® Palatal Expander System will be delivered. **Intervention Names:** - Device: IPE **Label:** Invisalign® Palatal Expander System **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Hyrax-type maxillary expander will be delivered. The Hyrax-type maxillary expander will include a midline self-locking screw, which is connected to the conventional molar bands or printed clasps, which are cemented on the maxillary first molars (or on the maxillary primary second molars), via 0.9 mm stainless-steel wire. The framework is soldered to the bands and extends on the palatal side to the primary canines or canines. The expander will be fabricated by a qualified laboratory technician **Intervention Names:** - Device: HE **Label:** Hyrax-type maxillary expander **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Invisalign® Palatal Expander System **Description:** Invisalign palatal expander system: The Invisalign® Palatal Expander System (AlignTechnology, inc.) is 3D-printed orthodontic device for maxillary expansion. **Name:** IPE **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Hyrax-type maxillary expander **Description:** Hyrax expander: The Hyrax-type maxillary expander will include a midline self-locking screw. The expansion screw is connected to the conventional molar bands or printed clasps, which are cemented on the maxillary first molars (or on the maxillary primary second molars), via 0.9 mm stainless-steel wire. The framework is soldered to the bands and extends on the palatal side to the primary canines or canines. The expander will be fabricated by a qualified laboratory technician **Name:** HE **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Transverse changes on CBCTs **Measure:** Width change **Time Frame:** 12-18 months **Description:** Arch width change measured on digital study casts **Measure:** Arch width change **Time Frame:** 12-18 months #### Secondary Outcomes **Description:** Common Cephalometric measurements changes on CBCT analysis **Measure:** Cephalometric changes **Time Frame:** 12-18 months ### Eligibility Module **Eligibility Criteria:** Inclusion criteria: 1. Mixed dentition phase with at least three nonmobile (stable) teeth which have more than 1/4 of primary molar root length left16 in either side 2. Early permanent dentition stage and early permanent dentition but second permanent molars not yet fully erupted in the arch 3. Unilateral or bilateral posterior cross bite patients; or Patients who have been diagnosed with transverse maxillary deficiency (Skeletal transverse discrepancy measured from the estimated center of resistances of the first molars17 ≤ - 3 mm); 4. Patients with Class I or Class II skeletal relationship 5. Subjects willing to consent to the trial Exclusion Criteria: 1. Any general medical health problems which may influence treatment 2. Any craniofacial anomalies 3. Skeletal Class III patients 4. Mixed dentition patients with more than 2 heavily restored primary second or permanent first molars. **Maximum Age:** 14 Years **Minimum Age:** 6 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** hsuh1@pacific.edu **Name:** Heeyeon Suh **Phone:** 415-351-7134 **Role:** CONTACT #### Locations **Location 1:** **City:** San Francisco **Contacts:** ***Contact 1:*** - **Email:** hsuh1@pacific.edu - **Name:** Heeyeon Suh - **Phone:** 415-351-7134 - **Role:** CONTACT **Country:** United States **Facility:** University of the Pacific **State:** California **Status:** RECRUITING **Zip:** 94103 #### Overall Officials **Official 1:** **Affiliation:** University of the Pacific **Name:** Heeyeon Suh **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414850 **Acronym:** MENTAL-DOG **Brief Title:** Animal-assisted Intervention in Adolescents Admitted to Acute Psychiatric Units. **Official Title:** Efficacy Study of an Animal-assisted Intervention in Adolescents Admitted to Acute Psychiatric Units: Mentaldog Multicenter Study. #### Organization Study ID Info **ID:** Multicenter study #### Organization **Class:** OTHER **Full Name:** Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina ### Status Module #### Completion Date **Date:** 2022-01-07 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-01-07 **Type:** ACTUAL #### Start Date **Date:** 2020-02-12 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Hospital Universitari Santa Maria, Lleida **Class:** OTHER **Name:** Hospital de Mataró **Class:** OTHER **Name:** Hospital Infantil Universitario Niño Jesús, Madrid, Spain **Class:** OTHER **Name:** Universidad Rey Juan Carlos #### Lead Sponsor **Class:** OTHER **Name:** Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The purpose of the present study was to evaluate the efficacy of AAT intervention in adolescents admitted to the Acute Child and Adolescent Psychiatry Unit, regardless of diagnosis, in terms of improving self-efficacy and reducing anxiety symptoms. To assess professional opinions on the effects of intervention on participants, and to determine participant satisfaction. These objectives were accomplished through a multicenter, non-randomized, open-label, two-arm controlled study of AAT for adolescents with mental disorders. **Detailed Description:** The rationale of this study was to evaluate the efficacy of Animal Assisted Therapy (with therapy dogs) in adolescents admitted to the Acute Child and Adolescent Psychiatry Unit and regardless of diagnosis. The investigators conducted a multicenter, non-randomized, controlled, open-label, two-arm clinical trial in three hospitals. A total of 178 adolescents admitted to the Acute Child and Adolescent Psychiatry Unit were included in the study. Participants from the three hospitals were assigned to Experimental Group (n=114) and participants from one hospital were assigned to Control Group (n=64). Both the experimental group and the control group carried out a total of two one-hour group sessions at the hospitals' own facilities, on a weekly basis for two consecutive weeks; with the additional assistance of the therapy dog in the Experimental group. The investigators evaluated changes on self-efficacy and anxiety symptoms at pre-treatment and post-treatment; and they assessed professional opinions on the effects of intervention on participants at post-treatment, and determined participant satisfaction at post-treatment. ### Conditions Module **Conditions:** - Mental Health Issue **Keywords:** - Animal-assisted therapy - Mental Health - Adolescent Psychiatry - Hospital - Nonpharmaceutical interventions ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL **Intervention Model Description:** Multicenter, non-randomized, controlled, open-label, two-arm clinical trial ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 178 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The experimental group carried out a total of two one-hour group sessions at the three hospitals' own facilities, on a weekly basis for two consecutive weeks. The groups were formed by 8-10 participants. Sessions included the participation of one certified therapy dog, one technician specialized in AAT, an occupational therapist and a psychologist. There was a referring psychiatrist for the project at each center. Participants received their usual pharmacological treatment. Intervention (with the additional assistance of the therapy dog): Session 1, self-efficacy (executive functions, cause-effect thinking). Session 2, emotional self-regulation and frustration tolerance. **Intervention Names:** - Behavioral: Animal Assisted Therapy (AAT) **Label:** Experimental Group (EG) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The control group carried out a total of two one-hour group sessions at the hospital's own facility, on a weekly basis for two consecutive weeks. The groups were formed by 8-10 participants. Sessions included the participation of an occupational therapist and a psychologist. There was a referring psychiatrist for the project. Participants received their usual pharmacological treatment. Intervention (same sessions without the therapy dog): Session 1, self-efficacy (executive functions, cause-effect thinking). Session 2, emotional self-regulation and frustration tolerance. **Intervention Names:** - Behavioral: Animal Assisted Therapy (AAT) **Label:** Control Group (CG) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Control Group (CG) - Experimental Group (EG) **Description:** A structured AAT program and pharmacological treatment in Experimental group. The same structured program without therapy dog and pharmacological treatment in Control group. **Name:** Animal Assisted Therapy (AAT) **Other Names:** - Dog assisted Therapy **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** The following question was asked in writing and answered by all participants (CG + EG): Did you enjoy the activity that was carried out? It consists of a Likert scale of 1= Not at all, 2= Somewhat, 3= Quite and 4= A lot. **Measure:** Participant satisfaction questionnaire at the end of the intervention. **Time Frame:** At the end of the intervention (week 2). #### Primary Outcomes **Description:** Is a generic self-administered instrument for measuring self-efficacy beliefs in certain life situations. The total scale score ranges from 10 to 40 points. **Measure:** Change from baseline General Self-Efficacy Scale (GSE) at 2 weeks. **Time Frame:** This scale was administered at baseline and at week 2 **Description:** Is a self-administered questionnaire that assesses the levels of clinical anxiety (both trait anxiety ("most of the time") and state anxiety ("at the present moment")). The total score on each of the subscales ranges from 0 to 60 points. **Measure:** Change from baseline State-Trait Anxiety Inventory Questionnaire (STAI) at 2 weeks. **Time Frame:** This questionnaire was administered at baseline and at week 2 #### Secondary Outcomes **Description:** This is a questionnaire that was completed by the professionals in the three hospitals at the end of the intervention with the EG, using a Likert scale from 1 to 4 (1= Not at all, 2= Somewhat, 3= Quite, and 4= A lot). It contains the following questions: * Have you observed any positive changes in the patient's attitude since the AAT session? * Has the dog generated motivation? * Do you consider AAT useful for this patient? **Measure:** Participant evaluation questionnaire for professionals. **Time Frame:** At the end of the intervention (week 2). ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Be between 13 and 17 years of age. * Willing to participate in the study on a voluntary basis. * Delivery of the information sheet and signature of the informed consent (participant and legal guardian). * Attendance at both group sessions from the intervention. Exclusion Criteria: * If in the initial interview they declared having allergy or fear of dogs. * History of aggression towards animals. * Re-admissions who had already participated in the study. * If, when informed, the patient and/or his/her legal guardian did not wish to participate in the study. **Maximum Age:** 17 Years **Minimum Age:** 13 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Mataró **Country:** Spain **Facility:** Hospital de Mataró **State:** Barcelona **Zip:** 08304 **Location 2:** **City:** Lleida **Country:** Spain **Facility:** Hospital Universitari Santa Maria **Zip:** 25198 **Location 3:** **City:** Madrid **Country:** Spain **Facility:** Hospital Universitario Infantil Niño Jesús **Zip:** 28009 #### Overall Officials **Official 1:** **Affiliation:** Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol) **Name:** M. Dolores Rodrigo Claverol, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: Rare - Name: Rare Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414837 **Brief Title:** Clinical Trial of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults **Official Title:** Study on Efficacy and Safety of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults #### Organization Study ID Info **ID:** HR091506-301 #### Organization **Class:** INDUSTRY **Full Name:** Jiangsu HengRui Medicine Co., Ltd. ### Status Module #### Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Jiangsu HengRui Medicine Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The study is being conducted to evaluate the efficacy, and safety of HR091506 tablets for treatment of gout with hyperuricemia in adults, and to compare the results with febuxostat tablets in the same doses. ### Conditions Module **Conditions:** - Gout With Hyperuricemia in Adults ### 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:** 434 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: HR091506 tablets + placebo of febuxostat tablets **Label:** Treatment group A: HR091506 tablets + placebo of febuxostat tablets **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: febuxostat tablets + placebo of HR091506 tablets **Label:** Treatment group B: febuxostat tablets + placebo of HR091506 tablets **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment group A: HR091506 tablets + placebo of febuxostat tablets **Description:** HR091506 tablets 20mg/ 40mg/ 60mg/80mg qd + placebo of febuxostat tablets 20mg/ 40mg/ 60mg/80mg qd, from Week 1 to 36. **Name:** HR091506 tablets + placebo of febuxostat tablets **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Treatment group B: febuxostat tablets + placebo of HR091506 tablets **Description:** febuxostat tablets 20mg/ 40mg/ 60mg/80mg qd + placebo of HR091506 tablets 20mg/ 40mg/ 60mg/80mg qd . from Week 1 to 36. **Name:** febuxostat tablets + placebo of HR091506 tablets **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** The proportion of subjects with serum uric acid level < 300 μmoL/L at Week 36 **Time Frame:** Week 36 #### Secondary Outcomes **Measure:** Proportion of subjects with serum uric acid level < 360 μmol/L at week 4,8,12,16,20,24,28,32,36 after administration **Time Frame:** at week 4,8,12,16,20,24,28,32,36 after administration **Measure:** Proportion of subjects with serum uric acid level < 300 μmol/L at week 4,8,12,16,20,24,28,32,36 after administration **Time Frame:** at week 4,8,12,16,20,24,28,32,36 after administration **Measure:** Change of serum uric acid level from baseline week 4,8,12,16,20,24,28,32,36 after administration **Time Frame:** week 4,8,12,16,20,24,28,32,36 after administration **Measure:** Proportion of subjects with ≥1 gout flare during the 36 weeks treatment stage **Time Frame:** during the 36 weeks treatment stage ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. 18-75 years old, male or female; 2. Meet the 2015 ACR/EULAR gout classification criteria; 3. Fast serum uric acid ≥ 480 μmol/L on 2 different days during the screening perid; 4. Patients with tophi, chronic arthropathy, frequent attacks; 5. Willing to ues contraceptive measures during the study; 6. Able and willing to provide a written informed consent. Exclusion Criteria: 1. History of acute gout attack within 4 weeks before randomization. 2. Subjects who have undergone major surgery or organ transplantation within 3 months before randomization. 3. Subjects with major cardiovascular disease within 6 months before randomization. 4. History of chronic infection or recurrent infection within 1year before randomization. 5. History of malignant tumor or current history of combined malignant tumor within 5 years before screening. 6. History of secondary hyperuricemia, refractory gout, or xanthine metabolism disorder. 7. Subjects with poorly controlled blood pressure or diabetes mellitus. 8. History of chronic diffuse connective tissue disease and/or massively elevated urate diseases and/or untreated clinically significant thyroid disease. 9. History of diseases that may affect the in vivo process, safety evaluation, or subjects' participation in the research. 10. Abnormal laboratory tests that may affect subjects participating in the research. 11. Combined use of prohibited drugs. 12. Allergic to ingredient or component of the experimental drug. 13. Participated in other clinical trials within 1 month before randomization. 14. Pregnant or nursing women. 15. History of drug abuse, drug use and/or excessive drinking within 1 year before screening. 16. The inestigators determined that other conditions were inappropriate for participation in this clinical trial. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ninghui.yan@hengrui.com **Name:** Ninghui Yan **Phone:** +0518-82342973 **Role:** CONTACT **Contact 2:** **Email:** jing.xu.jx23@hengrui.com **Name:** Jing Xu **Phone:** +0518-82342973 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000070657 - Term: Crystal Arthropathies - ID: D000012216 - Term: Rheumatic Diseases - ID: D000011686 - Term: Purine-Pyrimidine Metabolism, Inborn Errors - ID: D000008661 - Term: Metabolism, Inborn Errors - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000008659 - Term: Metabolic Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M24343 - Name: Hyperuricemia - Relevance: HIGH - As Found: Hyperuricemia - ID: M9177 - Name: Gout - Relevance: HIGH - As Found: Gout - 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: M630 - Name: Crystal Arthropathies - 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: M11641 - Name: Metabolism, Inborn Errors - Relevance: LOW - As Found: Unknown - ID: M14540 - Name: Purine-Pyrimidine Metabolism, Inborn Errors - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006073 - Term: Gout - ID: D000033461 - Term: Hyperuricemia ### Intervention Browse Module - Ancestors - ID: D000006074 - Term: Gout Suppressants - ID: D000018501 - Term: Antirheumatic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M434 - Name: Febuxostat - Relevance: HIGH - As Found: Mobile Health - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000069465 - Term: Febuxostat ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414824 **Acronym:** PENELOPE **Brief Title:** The isCGM Use and Hypoglycemic Episodes and Fear of Hypoglycemia in Newly Diagnosed Type 1 Diabetes **Official Title:** The Impact of the isCGM Use on the Hypoglycemic Episodes and Fear of Hypoglycemia in Patients With Newly Diagnosed Type 1 Diabetes #### Organization Study ID Info **ID:** PENELOPE #### Organization **Class:** OTHER **Full Name:** Jagiellonian University ### Status Module #### Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2022-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Diabetes Poland #### Lead Sponsor **Class:** OTHER **Name:** Jagiellonian University #### Responsible Party **Investigator Affiliation:** Jagiellonian University **Investigator Full Name:** Jerzy Hohendorff **Investigator Title:** MD, PhD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False ### Description Module **Brief Summary:** The aim of this trial is to investigate the impact of FreeStyle Libre use compared to SMBG on hypoglycemia episodes and fear of hypoglycemia in adults aged 18-35 with newly diagnosed type 1 diabetes. This trial is conducted in university centers in Poland (Bialystok, Krakow, Poznan, Zabrze). ### Conditions Module **Conditions:** - Diabetes Mellitus, Type 1 **Keywords:** - ambulatory glucose profile - time in range - fear of hypoglycemia - continuous glucose monitoring ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** FreeStyle Libre for 4 weeks. All subjects will wear a masked sensor (FreeStyle Libre Pro) for 14 days prior to randomisation. **Intervention Names:** - Device: Intermittently Scanned Continuous Glucose Monitoring **Label:** FreeStyle Libre **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Subjects randomised to the control group will monitor their blood glucose with standard blood glucose meters. A 14-day FreeStyle Libre Pro is included for these subjects from day 14 to day 28 to collect glycaemic data for comparison to the intervention group of the study. All subjects will wear a masked sensor (FreeStyle Libre Pro) for 14 days prior to randomisation. **Intervention Names:** - Device: Standard Blood Glucose Monitoring **Label:** SMBG **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - FreeStyle Libre **Description:** FreeStyle Libre, 4 weeks **Name:** Intermittently Scanned Continuous Glucose Monitoring **Other Names:** - FreeStyle Libre **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - SMBG **Description:** Standard blood glucose monitoring with glucose meters **Name:** Standard Blood Glucose Monitoring **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Change in HFS II score from baseline to day 28 **Measure:** Hypoglycemia Fear Survey II **Time Frame:** Baseline and day 28 **Description:** Difference in time \<70 mg/dL between intervention and control group assessed in days 14 to 28 **Measure:** TBR <70 mg/dL **Time Frame:** Baseline and days 14 to 28 #### Secondary Outcomes **Description:** Difference in TIR 70-180 mg/dL between intervention and control group assessed in days 14 to 28 **Measure:** TIR **Time Frame:** Baseline and days 14 to 28 **Description:** Difference in TBR \<54 mg/dL between intervention and control group assessed in days 14 to 28 **Measure:** TBR <54 mg/dL **Time Frame:** Baseline and days 14 to 28 **Description:** Difference in TAR \>180 mg/dL between intervention and control group assessed in days 14 to 28 **Measure:** TAR >180 mg/dl **Time Frame:** Baseline and days 14 to 28 **Description:** Difference in TAR \>250 mg/dL between intervention and control group assessed in days 14 to 28 **Measure:** TAR >250 mg/dl **Time Frame:** Baseline and days 14 to 28 **Description:** Difference in number of hospitalizations for diabetic ketoacidosis between intervention and control group **Measure:** DKA **Time Frame:** Baseline to day 28 **Description:** Difference in number of severe hypoglycemia episodes between intervention and control group **Measure:** Severe hypoglycemia **Time Frame:** Baseline to day 28 **Description:** Change in DDS score from baseline to day 28 **Measure:** DDS **Time Frame:** Baseline and day 28 **Description:** Change in DTSQ score from baseline to day 28 **Measure:** DTSQ **Time Frame:** Baseline and day 28 **Description:** Change in HFS II - worry subscale from baseline to day 28 **Measure:** HFS II - Worry subscale **Time Frame:** Baseline and day 28 **Description:** Change in HFS II - behaviour subscale from baseline to day 28 **Measure:** HFS II - Behaviour subscale **Time Frame:** Baseline and day 28 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Newly diagnosed type 1 diabetes (diagnosed based on the WHO criteria) no later than 6 months after the diagnosis. * Insulin therapy: multiple daily injections, * In the investigator's opinion, the participant must be technically capable of using the FreeStyle Libre system Exclusion Criteria: * Current or past use of any continuous glucose monitoring system. * Pump therapy. * Known allergy to medical adhesives. * Oral steroid therapy. * Pregnancy or planning pregnancy within the study duration. * Breast feeding. * Dialysis treatment. * Having a pacemaker. * Unstable coronary heart disease. * Cystic fibrosis. * Cancer. * Psychiatric disorders. * Severe end-organ damage (kidney, liver, etc) or any uncontrolled disorder. * Hospitalization for any reason other than the newly diagnosed type 1 diabetes 6 months prior to inclusion. * Participating in another clinical trial that could affect glucose measurements or glucose management. * In the investigator's opinion, if the participant is considered unsuitable for inclusion in the study for any other reason. **Maximum Age:** 35 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jerzy.hohendorff@uj.edu.pl **Name:** Jerzy Hohendorff, MD, PhD **Phone:** +48124002950 **Role:** CONTACT #### Locations **Location 1:** **City:** Bialystok **Country:** Poland **Facility:** Department of Endocrinology, Diabetology and Internal Medicine, Medical University of Bialystok **Status:** RECRUITING **Location 2:** **City:** Krakow **Country:** Poland **Facility:** Department of Metabolic Diseases, Jagiellonian University Medical College **Status:** RECRUITING **Location 3:** **City:** Poznan **Country:** Poland **Facility:** Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences **Status:** RECRUITING **Location 4:** **City:** Zabrze **Country:** Poland **Facility:** Department of Internal Medicine, Diabetology, and Cardiometabolic Disorders, Medical University of Silesia in Katowice **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes - ID: M7117 - Name: Diabetes Mellitus, Type 1 - Relevance: HIGH - As Found: 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 ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414811 **Brief Title:** Tapse/Pasp General Anesthesia **Official Title:** Prediction of TAPSE/PASP Ratio for Hypotension Due to General Anesthesia Induction #### Organization Study ID Info **ID:** 2024-44 #### Organization **Class:** OTHER **Full Name:** Aydin Adnan Menderes University ### Status Module #### Completion Date **Date:** 2025-03-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-01-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Aydin Adnan Menderes University #### Responsible Party **Investigator Affiliation:** Aydin Adnan Menderes University **Investigator Full Name:** ferdi gülaştı **Investigator Title:** ASS. PROF. DR **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** TAPSE, one of the methods for evaluating right ventricular systolic function; It is a bar parameter that can easily measure apex-basal shortening and provides specific information about global RV function. TAPSE/PASP can be calculated as load-independent parameters to evaluate RV function. Because RV function is sensitive to change in afterload, known as the RV-pulmonary circulation (PC) connection. This study aims to identify patients who are candidates for hypotensive events due to general anesthesia in a hemodynamically stable population. **Detailed Description:** TAPSE, one of the methods for evaluating right ventricular systolic function; It is a bar parameter that can easily measure apex-basal shortening and provides specific information about global RV function. TAPSE/PASP can be calculated as load-independent parameters to evaluate RV function. Because RV function is sensitive to change in afterload, known as the RV-pulmonary circulation (PC) connection. This study aims to identify patients who are candidates for hypotensive events due to general anesthesia in a hemodynamically stable population. Patients will be measured by transthoracic echocardiography in the preoperative period, 15-30 minutes before induction. Basal hemodynamic parameters and non-invasive and/or hemodynamic values will be recorded every two minutes after induction until surgical incision.Patients with a 30% decrease in SBP from the baseline and a decrease in MAP below 65 mmHg in the first 10 minutes after anesthesia induction will be considered to have hypotension. Patients will be divided into 2 groups: 'with' and 'without' hypotension. ### Conditions Module **Conditions:** - Hypotension **Keywords:** - TAPSE - PASP - GENERAL ANESTHESİA ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 52 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Day ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with a 30% decrease in SBP from baseline and a decrease in MAP below 65 mmHg in the first 10 minutes after anesthesia induction will be considered to have hypotension. **Intervention Names:** - Other: HYPOTENSİON **Label:** Hypotension #### Arm Group 2 **Description:** Patients who do not have a 30% decrease from the baseline in SBP and a decrease in MAP below 65 mmHg in the first 10 minutes after anesthesia induction will be considered as not having hypotension. **Label:** none hypotension ### Interventions #### Intervention 1 **Arm Group Labels:** - Hypotension **Description:** MAP below 55 mmHg or long-term (2 minutes or more) hypotensive attacks will be treated with ephedrine 0.1mg/kg. **Name:** HYPOTENSİON **Other Names:** - TREATMENT **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Intraoperative systolic arterial tension, diastolic arterial tension and mean arterial tension will be taken and recorded for the patients. **Measure:** 1. tension **Time Frame:** 4-5 hours] ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Written informed consent; 2. 18-75 years old 3. ASA Physical Status 1-3; 4. Patients planned for surgery Exclusion Criteria: 1. The patient is pregnant 2. After cardiac surgery 3. Severe pulmonary hypertension 4. Severe valve disease 5. Hypertrophic or dilated cardiomyopathy 6. Presence of acute myocardial infarction 7. Patients with severe visual or hearing impairment/disability 8. ASA physical status IV or V 9. Ischemic heart disease, conduction disorder. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** ASA1-3 patients aged 18-75 who will undergo elective surgery ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ferdigulasti@gmail.com **Name:** ferdi gülaştı **Phone:** +905054929650 **Role:** CONTACT #### Locations **Location 1:** **City:** Aydın **Country:** Turkey **Facility:** Ferdi Gülaştı **Zip:** 09020 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10072 - Name: Hypotension - Relevance: HIGH - As Found: Hypotension - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007022 - Term: Hypotension ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AnAg - Name: Antihypertensive Agents - Abbrev: VaCoAg - Name: Vasoconstrictor Agents - Abbrev: CNSSti - Name: Central Nervous System Stimulants - Abbrev: Resp - Name: Respiratory System Agents ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4277 - Name: Antihypertensive Agents - Relevance: LOW - As Found: Unknown - ID: M7966 - Name: Ephedrine - Relevance: LOW - As Found: Unknown - ID: M27586 - Name: Pseudoephedrine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414798 **Brief Title:** A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABBV-1088 Oral Dose in Healthy Adult Participants. **Official Title:** A First-in-Human Single Ascending Dose and Mass Balance Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABBV-1088 in Healthy Adult Subjects #### Organization Study ID Info **ID:** M24-929 #### Organization **Class:** INDUSTRY **Full Name:** AbbVie ### Status Module #### Completion Date **Date:** 2024-11-28 **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:** 2024-11-28 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-13 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** AbbVie #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study will assess the single dose safety, tolerability and pharmacokinetic properties of ABBV-1088 in healthy adult participants ### Conditions Module **Conditions:** - Healthy Volunteers **Keywords:** - Healthy Volunteers - ABBV-1088 ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 48 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive single dose of ABBV-1088 dose A on day 1 **Intervention Names:** - Drug: Drug: ABBV-1088 **Label:** Group 1- ABBV-1088 Dose A **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive single dose of placebo day 1 **Intervention Names:** - Drug: Drug: Placebo for ABBV-1088 **Label:** Group 1- Placebo **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Participants will receive single dose of ABBV-1088 dose B on day 1 **Intervention Names:** - Drug: Drug: ABBV-1088 **Label:** Group 2- ABBV-1088 Dose B **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Participants will receive single dose of placebo day 1 **Intervention Names:** - Drug: Drug: Placebo for ABBV-1088 **Label:** Group 2- Placebo **Type:** EXPERIMENTAL #### Arm Group 5 **Description:** Participants will receive single dose of ABBV-1088 dose C on day 1 **Intervention Names:** - Drug: Drug: ABBV-1088 **Label:** Group 3- ABBV-1088 Dose C **Type:** EXPERIMENTAL #### Arm Group 6 **Description:** Participants will receive single dose of placebo day 1 **Intervention Names:** - Drug: Drug: Placebo for ABBV-1088 **Label:** Group 3- Placebo **Type:** EXPERIMENTAL #### Arm Group 7 **Description:** Participants will receive single dose of ABBV-1088 dose D on day 1 **Intervention Names:** - Drug: Drug: ABBV-1088 **Label:** Group 4- ABBV-1088 Dose D **Type:** EXPERIMENTAL #### Arm Group 8 **Description:** Participants will receive single dose of placebo day 1 **Intervention Names:** - Drug: Drug: Placebo for ABBV-1088 **Label:** Group 4- Placebo **Type:** EXPERIMENTAL #### Arm Group 9 **Description:** Participants will receive single dose of ABBV-1088 dose E on day 1 **Intervention Names:** - Drug: Drug: ABBV-1088 **Label:** Group 5- ABBV-1088 Dose E **Type:** EXPERIMENTAL #### Arm Group 10 **Description:** Participants will receive single dose of placebo day 1 **Intervention Names:** - Drug: Drug: Placebo for ABBV-1088 **Label:** Group 5- Placebo **Type:** EXPERIMENTAL #### Arm Group 11 **Description:** Participants will receive single dose of ABBV-1088 dose F on day 1 **Intervention Names:** - Drug: Drug: ABBV-1088 **Label:** Group 6- ABBV-1088 Dose F **Type:** EXPERIMENTAL #### Arm Group 12 **Description:** Participants will receive single dose of placebo day 1 **Intervention Names:** - Drug: Drug: Placebo for ABBV-1088 **Label:** Group 6- Placebo **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Group 1- ABBV-1088 Dose A - Group 2- ABBV-1088 Dose B - Group 3- ABBV-1088 Dose C - Group 4- ABBV-1088 Dose D - Group 5- ABBV-1088 Dose E - Group 6- ABBV-1088 Dose F **Description:** • Oral Capsule **Name:** Drug: ABBV-1088 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Group 1- Placebo - Group 2- Placebo - Group 3- Placebo - Group 4- Placebo - Group 5- Placebo - Group 6- Placebo **Description:** • Oral Capsule **Name:** Drug: Placebo for ABBV-1088 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Cmax of ABBV-1088 **Measure:** Maximum Plasma Concentration (Cmax) of ABBV-1088 **Time Frame:** Up to approximately 11 days **Description:** Tmax of ABBV-1088 **Measure:** Time to Cmax (Tmax) of ABBV-1088 **Time Frame:** Up to approximately 11 days **Description:** Terminal phase elimination rate constant (beta) of ABBV-1088 **Measure:** Terminal Phase Elimination Rate Constant (Beta) of ABBV-1088 **Time Frame:** Up to approximately 11 days **Description:** Terminal phase elimination half-life of ABBV-1088 **Measure:** Terminal Phase Elimination Half-Life (t1/2) of ABBV-1088 **Time Frame:** Up to approximately 11 days **Description:** AUCt of ABBV-1088 **Measure:** Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-1088 **Time Frame:** Up to approximately 11 days **Description:** AUCinf of ABBV-1088 **Measure:** Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-1088 **Time Frame:** Up to approximately 11 days **Description:** An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study **Measure:** Number of Participants With Adverse Events (AEs) **Time Frame:** Up to Day 32 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * BMI is ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at screening. * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG Exclusion Criteria: * History of cardiac disease, including congenital structural/conduction abnormalities, cardiomyopathy, myocardial infarction, cardiac arrhythmia. * History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption \[e.g., Crohn's disease, chronic GERD, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\]. * History of suicidal ideation within one year prior to study drug administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the C-SSRS completed at Screening, or any history of suicide attempts within the last two years. * History of any clinically significant neurological, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness. **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** abbvieclinicaltrials@abbvie.com **Name:** ABBVIE CALL CENTER **Phone:** 844-663-3742 **Role:** CONTACT #### Locations **Location 1:** **City:** Grayslake **Country:** United States **Facility:** Acpru /Id# 264249 **State:** Illinois **Status:** RECRUITING **Zip:** 60030 #### Overall Officials **Official 1:** **Affiliation:** AbbVie **Name:** ABBVIE INC. **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### See Also Links **Label:** Related Info **URL:** https://www.abbvieclinicaltrials.com/study/?id=M24-929 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414785 **Acronym:** INFLAMA **Brief Title:** Characterization of Capsule Inflammation in Patients Exposed to Silicone Breast Implants **Official Title:** INFLAMA : Histological and Molecular Characterization of Capsule Inflammation in Patients Exposed to Silicone Breast Implants #### Organization Study ID Info **ID:** 2024/870 #### Organization **Class:** OTHER **Full Name:** Centre Hospitalier Universitaire de Besancon ### Status Module #### Completion Date **Date:** 2025-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-03 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Institut de Science des Matériaux de Mulhouse IS2M **Class:** UNKNOWN **Name:** NOVOTEC labs (lyon) #### Lead Sponsor **Class:** OTHER **Name:** Centre Hospitalier Universitaire de Besancon #### 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 use of breast implants, both in cosmetic and restorative surgery, is common. It is a device consisting of a silicone elastomer envelope and the container of which may be silicone gel or saline. They can be texturing carriers (roughness) on the surface of their envelope. If silicone is considered inert and biocompatible, several phenomena should be noted: * Implant placement results in the formation of a periprosthetic capsule which is the product of the inflammatory reaction and will isolate it from adjacent breast tissue * The periprosthetic capsule and adjacent breast tissue are chronically exposed to implant silicone. * Silicone in implants, even intact, has been shown to diffuse through the shell into the periprosthetic compartment and adjacent breast tissue * There is a phenomenon of erosion of the surface of the implants, particularly textured, responsible for the release of silicone particles within the periprosthetic capsule * The rupture of the prosthetic envelope is a dreaded complication, due to the alteration of the aesthetic result and the possibility of leakage of silicone gel * Since 2016, macrotextured implants have been implicated in the occurrence of anaplastic large cell lymphoma associated with breast implants (LAC-AIM) The presence of silicone in contact with tissues seems to promote an inflammatory environment, and this phenomenon seems increased if the implant is textured. Chronic inflammation induced by these devices can therefore have harmful consequences in the long term. INFLAMA study interested in the consequences of the presence of a silicone implant on local inflammatory phenomena within the periprosthetic capsule. ### Conditions Module **Conditions:** - Breast Implant; Complications - Breast Expansion Prosthesis **Keywords:** - type of texturing of implants - periprosthetic capsule fragment ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** characteristics of inflammation and the importance of silicone exposure (intact implant, implant rupture in serum or silicone) at the genomic molecular level, by analyzing the level of expression of genes related to the extracellular matrix and inflammation within a periprosthetic capsule fragment **Name:** analysis of samples of periprosthetic capsules taken during breast implant change procedure **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Verify the existence of a relationship between the characteristics of inflammation and the importance of silicone exposure (intact implant, implant rupture in serum or silicone) at the genomic molecular level, by analyzing the level of expression of genes related to the extracellular matrix and inflammation within a periprosthetic capsule fragment **Measure:** characteristics of inflammation according to the importance of silicone exposure **Time Frame:** immediately after surgery #### Secondary Outcomes **Description:** Check the existence of a relationship between the characteristics of inflammation and the type of texturing of implants (smooth, micro textured or macro textured), on the genomic molecular level, by analyzing the level of expression of genes related to the extracellular matrix and inflammation within a periprosthetic capsule fragment. **Measure:** characteristics of inflammation according to the type of texturing of implants **Time Frame:** immediately after surgery **Measure:** Characterize the inflammatory reaction within the periprosthetic capsule histologically, depending on the importance of silicone exposure. **Time Frame:** immediately after surgery **Measure:** Characterize the inflammatory reaction within the periprosthetic capsule histologically, according to texturation. **Time Frame:** immediately after surgery **Measure:** Identify a possible relationship between the characteristics of inflammation and the presence of a clinical shell. **Time Frame:** immediately after surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Women over the age of 18 years old * Requiring a change of unilateral/bilateral breast implants or breast expansion prosthesis for cosmetic surgery or breast reconstruction * Subject not objecting to the use of personal data and/or biological samples * Affiliation to or beneficiary of a French social security scheme. Exclusion Criteria: * Transgender men and patients * Pregnant women, and nursing mothers * Persons deprived of their liberty by a judicial or administrative decision; * Persons undergoing psychiatric care under duress; * Persons admitted to a health or social establishment for purposes other than research * Persons of full age who are subject to a legal protection measure or who cannot express their consent * Subject being in the period of exclusion from another study or foreseen by the "national volunteer file". **Gender Based:** True **Maximum Age:** 99 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Women Requiring a change of unilateral/bilateral breast implants or breast expansion prosthesis ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** i1pluvy@chu-besancon.fr **Name:** Isabelle PLUVY, MD **Phone:** +33381218988 **Role:** CONTACT **Contact 2:** **Email:** apozet@chu-besancon.fr **Name:** astrid pozet **Role:** CONTACT #### Locations **Location 1:** **City:** Besançon **Contacts:** ***Contact 1:*** - **Email:** i1pluvy@chu-besancon.fr - **Name:** Isabelle Pluvy, MD - **Role:** CONTACT **Country:** France **Facility:** CHU de Besançon **Status:** RECRUITING **Zip:** 25030 #### Overall Officials **Official 1:** **Affiliation:** CHU de Besançon **Name:** Isabelle PLUVY **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - 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: M10293 - Name: Inflammation - Relevance: HIGH - As Found: Inflammation ### Condition Browse Module - Meshes - ID: D000007249 - Term: Inflammation ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414772 **Acronym:** ENTENTE **Brief Title:** Evaluation of an E-tool Designed to Facilitate Communication Between Allophone Patients and Pediatricians in Emergency Departments. **Official Title:** Evaluation of an Electronic Tool Designed to Facilitate Communication Between Allophone Patients or Patients With Communication Difficulties and Physicians in Pediatric Emergency Departments. #### Organization Study ID Info **ID:** 2022/739 #### Organization **Class:** OTHER **Full Name:** Centre Hospitalier Universitaire de Besancon ### Status Module #### Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **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:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-01-10 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Centre Hospitalier Universitaire de Besancon #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** In France, over 21 million people visit emergency departments every year, 10% of whom speak little or no French. The language barrier is a problem for patient safety and quality of care. Ethical and financial aspects are also affected. Unnecessary tests are more frequent, hospital stays more numerous and longer. Patient's management may be inappropriate. Patients are less satisfied, understand and adhere less to cmanagement and recommendations. Some solutions are available to the emergency physician, but their contribution is limited. A professional interpreter is reliable and takes cultural aspects into account, but his or her cost is high and availability incompatible with emergency care. Translation by a close relative poses the problem of confidentiality. Telephone interpreting is available at any time, but is expensive and less satisfying than direct interaction. Computerized machine translation is economical and easy to access, but does not take into account all medical terms. It also poses a data protection problem. Phraselators translate predefined phrases with precision, but are time-consuming and unsophisticated. In addition, these aids are used during the consultation. They are therefore difficult to combine and take up care time. This care time is mainly devoted to establishing medical history essential for the diagnosis, prognosis and treatment decisions. MARTI is a digital tool for pediatric emergency room consultations. Its aim is to enable the emergency physician to start the consultation with a medical history completed autonomously by the parents during their waiting time. Its content has been developed by emergency physicians. Language and cultural barriers are overcome through the use of simple phrases and pictograms developed with linguists, language schools and Immigrant organizations. MARTI was used in a pediatric emergency department. Feedback from patients and carers indicates that it is ready to be tested in real-life conditions. This pilot study is designed to evaluate how MARTI improves communication with an allophone or a person with comprehension difficulties, according to the emergency physician in charge of the consultation. ### Conditions Module **Conditions:** - Language Barrier ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Use of MARTI application in addition with a classical consultation/support **Label:** With MARTI e-tool **Type:** EXPERIMENTAL #### Arm Group 2 **Label:** Without MARTI e-tool **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - With MARTI e-tool **Description:** Participants will use MARTI in order to establish the medical history during their waiting time. **Name:** Use of MARTI application in addition with a classical consultation/support **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The quality of communication will be assessed using a Likert-type scale to be completed by the emergency physician at the end of the consultation (whether MARTI was used or not). Originally, Likert scale is a rating scale that assesses opinions, attitudes, or behaviors quantitatively in five point expressed as follows: strongly agree, agree, neutral, disagree, strongly disagree. These points have been kept for the scale of the study, which was adapted with items like "Using MARTI app reduced my anxiety" (for caregivers), "The app is easy to use" (for parents), etc. **Measure:** Quality of communication **Time Frame:** Day 1 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult * Person responsible for a child admitted to pediatric emergency. * Person with a language barrier. * Person speaking one of the 11 languages proposed by MARTI. * Signed informed consent indicating that the subject has understood the purpose and procedures of the study and agrees to participate in the study and to abide by the requirements and restrictions inherent in the study. * Affiliation with a health insurance Exclusion Criteria: * Person who shares a common language with the physician. * Illiterate person. * Person accompanying a child with a life-threatening emergency. * Subject without health insurance. * Pregnant women. * Subject in the exclusion period of another study or in the "national volunteer file". **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jmirete@chu-besancon.fr **Name:** Justine Mirete, MD **Phone:** 33 3 81 93 31 **Role:** CONTACT **Contact 2:** **Name:** Jean-Baptiste Pretalli, PhD **Phone:** 33 3 81 21 81 27 **Role:** CONTACT #### Locations **Location 1:** **City:** Besançon **Contacts:** ***Contact 1:*** - **Email:** kmouyabi@chu-besancon.fr - **Name:** Kristina Mouyabi - **Phone:** 33 3 81 21 83 56 - **Role:** CONTACT ***Contact 2:*** - **Name:** Justine Mirete, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** CHU de Besançon **Zip:** 25000 **Location 2:** **City:** Trévenans **Contacts:** ***Contact 1:*** - **Name:** Thibaut Pégeot, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** Hôpital Nord Franche-Comté ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7796 - Name: Emergencies - Relevance: HIGH - As Found: Emergency - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004630 - Term: Emergencies ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414759 **Brief Title:** Efficacy and Safety of Combination Diuretic Therapy in Patients With Acute Decompensated Heart Failure and Volume Overload **Official Title:** Efficacy and Safety of Combination Diuretic Therapy in Patients With Acute Decompensated Heart Failure and Volume Overload #### Organization Study ID Info **ID:** CL3575 #### Organization **Class:** OTHER **Full Name:** Cairo University #### Secondary ID Infos **Domain:** General Organization for Teaching Hospitals and Institutes (GOTHI) **ID:** IHC00077 **Type:** REGISTRY ### Status Module #### Completion Date **Date:** 2025-03-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-22 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** National Heart Institute, Egypt #### Lead Sponsor **Class:** OTHER **Name:** Cairo University #### Responsible Party **Investigator Affiliation:** Misr International University **Investigator Full Name:** Mohamed Ahmed Naguib Mohamed Abdelmoaty **Investigator Title:** Teaching Assistant of Clinical Pharmacy **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study aims to compare two medications, acetazolamide and metolazone, along with loop diuretics, to see which one works better and is safer for patients with ADHF who have volume overload. By comparing these medications, we hope to learn which one can help these patients the most. This will help doctors choose the best treatment for patients with ADHF and volume overload. ### Conditions Module **Conditions:** - Acute Decompensated Heart Failure - Volume Overload - Edema **Keywords:** - ADHF - Acute Decompensated Heart Failure - AHF - Acute Heart Failure - Volume overload - Edema - Loop diuretics - Fusrosemide - Metolazone - Acetazolamide - Carbonic anhydrase inhibitor - Thiazide like diuretics - Thiazide diuretics ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Prospective, randomized, single-blinded, controlled trial ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 110 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** First group (IV loop Diuretics + oral acetazolamide): patients will receive IV loop diuretic 2 times the outpatient oral (PO) daily dose, and oral loop diuretics will be stopped. In cases where the patient was not previously on oral diuretics, a starting dose of 40 mg of IV furosemide, IV bumetanide 1 mg or a bolus of 20 mg of IV torsemide can be utilized, together with acetazolamide: 500 mg PO once daily. **Intervention Names:** - Drug: Acetazolamide - Drug: IV Loop Diuretics **Label:** Group 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Second group (IV loop diuretics + oral metolazone): patients will receive IV loop diuretic approximately 2 times the outpatient oral daily dose, and oral loop diuretics will be stopped. In cases where the patient was not previously on oral diuretics, a starting dose of 40 mg of IV furosemide, IV bumetanide 1 mg or a bolus of 20 mg of IV torsemide can be utilized, together with metolazone: 5 mg PO once daily. **Intervention Names:** - Drug: Metolazone - Drug: IV Loop Diuretics **Label:** Group 2 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Group 1 **Description:** Acetazolamide is a medication that belongs to the class of carbonic anhydrase inhibitors. It acts by reducing the reabsorption of sodium in the proximal tubules of the kidneys. When combined with loop diuretics, acetazolamide has the potential to enhance the effectiveness of diuretic therapy, thus aiding in the process of decongestion. It will be given 500mg orally, once daily. **Name:** Acetazolamide **Other Names:** - Carbonic anhydrase inhibitor **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Group 2 **Description:** Metolazone is a medication with properties like thiazide diuretics, prescribed for the management of congestive heart failure and hypertension. Its mechanism of action involves blocking the transport of sodium across the epithelium of renal tubules, predominantly in the distal tubules. It will be given 5mg orally, once daily. **Name:** Metolazone **Other Names:** - Thiazide like diuretic **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Group 1 - Group 2 **Description:** IV loop diuretic 2 times the outpatient oral (PO) daily dose, and oral loop diuretics will be stopped. In cases where the patient was not previously on oral diuretics, a starting dose of 40 mg of IV furosemide, IV bumetanide 1 mg or a bolus of 20 mg of IV torsemide can be utilized. **Name:** IV Loop Diuretics **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Total Urine output Volume **Measure:** Urine Output **Time Frame:** 48 Hours #### Secondary Outcomes **Description:** Urine output/40 mg furosemide equivalent **Measure:** Diuretic Response **Time Frame:** 48 Hours **Description:** Change in Body Weight **Measure:** Body Weight **Time Frame:** 48 Hours **Description:** Change in congestion score (Modified ADVOR Trial Congestion Score) **Measure:** Congestion Score **Time Frame:** 48 Hours **Description:** Change in NT-Pro BNP/BNP levels **Measure:** NT-proBNP/BNP **Time Frame:** On admission and before discharge (up to 2 Weeks) **Description:** Change in bicarbonate level from baseline \[ABG\] **Measure:** Bicarbonate Level **Time Frame:** 48 Hours **Description:** Change in serum creatinine (SCr) **Measure:** Serum Creatinine **Time Frame:** 48 Hours **Description:** Change in estimated glomerular filtration rate (eGFR) from baseline **Measure:** eGFR **Time Frame:** 48 Hours **Description:** Change in systolic blood pressure (SBP) from baseline **Measure:** Blood Pressure **Time Frame:** 48 Hours **Description:** Change in serum potassium from baseline **Measure:** Serum Potassium **Time Frame:** 48 Hours **Description:** Both general ward and CCU **Measure:** Length of Hospital Stay **Time Frame:** Up to 2 weeks **Description:** All-cause mortality and heart failure readmission during 3 months of follow-up **Measure:** Mortality or HF Events **Time Frame:** 3 Months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or female patients with ages ≥ 18 years old, and less than 65 years old. * For both elective and emergency hospital admissions, patients with a clinical diagnosis of ADHF must exhibit at least one clinical sign indicative of volume overload. These signs may include edema (score 2 or higher), ascites confirmed through echography, or pleural effusion confirmed by chest X-ray or echography or rales on auscultation, or jugular venous pressure greater than10 mm Hg. Exclusion Criteria: * Patient diagnosed with acute kidney injury upon hospital admission based on the presence of any of the following criteria: an increase in SCr by at least 0.3 mg/dL within 48 hours, an increase in SCr to at least 2 times the baseline value, known or presumed to have occurred within the prior 7 days, and a urine volume less than 0.5 ml/kg/hour for a duration of 6 hours. * Patients with acute pulmonary edema caused by increased afterload and fluid redistribution to the lungs in the absence or with minimal fluid accumulation. * Anticipated exposure to nephrotoxic agents (such as contrast dye) during hospitalization. * Patients who exhibit anuria or are undergoing renal replacement therapy or ultrafiltration. * Patients with eGFR less than 30 mL/min/1.73m² at the time of screening. * Expected use of intravenous inotropes, vasopressors, or nitroprusside during the study. * Prior cardiac transplantation and/or utilization of a ventricular assist device. * Blood pressure below 90 mmHg or mean arterial pressure below 65 mmHg at the time of recruitment. * Patients who are pregnant or breastfeeding. * Administration of acetazolamide or metolazone within the one-month period preceding randomization. * The usage of any diuretic agent during the treatment phase is not specified in the study protocol, except for mineralocorticoid receptor antagonists. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** mohamed.naguib@miuegypt.edu.eg **Name:** Mohamed AN Abdelmoaty, B.Sc. Pharmaceutical Sciences **Phone:** +201146631157 **Role:** CONTACT #### Locations **Location 1:** **City:** Giza **Contacts:** ***Contact 1:*** - **Email:** mohamed.naguib@miuegypt.edu.eg - **Name:** Mohamed AN Abdelmoaty, B.Sc. Pharmaceutical Sciences - **Phone:** +201146631157 - **Role:** CONTACT ***Contact 2:*** - **Name:** Bassem Zarif, PhD, Cardiology - **Phone:** +201223950548 - **Role:** CONTACT ***Contact 3:*** - **Name:** Mohamed AN Abdelmoaty, B.Sc. Pharmaceutical Sciences - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Nirmeen Sabry, PhD, Clinical Pharmacy - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 5:*** - **Name:** Bassem Zarif, PhD, Cardiology - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 6:*** - **Name:** Sahar Atef, PhD, Clinical Pharmacy - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Egypt **Facility:** National Heart Institute **State:** GZ **Zip:** 3755204 ### References Module #### References **Citation:** Arrigo M, Jessup M, Mullens W, Reza N, Shah AM, Sliwa K, Mebazaa A. Acute heart failure. Nat Rev Dis Primers. 2020 Mar 5;6(1):16. doi: 10.1038/s41572-020-0151-7. **PMID:** 32139695 **Citation:** Njoroge JN, Teerlink JR. Pathophysiology and Therapeutic Approaches to Acute Decompensated Heart Failure. Circ Res. 2021 May 14;128(10):1468-1486. doi: 10.1161/CIRCRESAHA.121.318186. Epub 2021 May 13. **PMID:** 33983837 **Citation:** Hsiao R, Greenberg B. Contemporary Treatment of Acute Heart Failure. Prog Cardiovasc Dis. 2016 Jan-Feb;58(4):367-78. doi: 10.1016/j.pcad.2015.12.005. Epub 2016 Jan 5. **PMID:** 26764279 **Citation:** Kurmani S, Squire I. Acute Heart Failure: Definition, Classification and Epidemiology. Curr Heart Fail Rep. 2017 Oct;14(5):385-392. doi: 10.1007/s11897-017-0351-y. **PMID:** 28785969 **Citation:** Rubio-Gracia J, Demissei BG, Ter Maaten JM, Cleland JG, O'Connor CM, Metra M, Ponikowski P, Teerlink JR, Cotter G, Davison BA, Givertz MM, Bloomfield DM, Dittrich H, Damman K, Perez-Calvo JI, Voors AA. Prevalence, predictors and clinical outcome of residual congestion in acute decompensated heart failure. Int J Cardiol. 2018 May 1;258:185-191. doi: 10.1016/j.ijcard.2018.01.067. **PMID:** 29544928 **Citation:** Mentz RJ, Kjeldsen K, Rossi GP, Voors AA, Cleland JG, Anker SD, Gheorghiade M, Fiuzat M, Rossignol P, Zannad F, Pitt B, O'Connor C, Felker GM. Decongestion in acute heart failure. Eur J Heart Fail. 2014 May;16(5):471-82. doi: 10.1002/ejhf.74. Epub 2014 Mar 5. **PMID:** 24599738 **Citation:** Felker GM, Lee KL, Bull DA, Redfield MM, Stevenson LW, Goldsmith SR, LeWinter MM, Deswal A, Rouleau JL, Ofili EO, Anstrom KJ, Hernandez AF, McNulty SE, Velazquez EJ, Kfoury AG, Chen HH, Givertz MM, Semigran MJ, Bart BA, Mascette AM, Braunwald E, O'Connor CM; NHLBI Heart Failure Clinical Research Network. Diuretic strategies in patients with acute decompensated heart failure. N Engl J Med. 2011 Mar 3;364(9):797-805. doi: 10.1056/NEJMoa1005419. **PMID:** 21366472 **Citation:** Hoorn EJ, Ellison DH. Diuretic Resistance. Am J Kidney Dis. 2017 Jan;69(1):136-142. doi: 10.1053/j.ajkd.2016.08.027. Epub 2016 Nov 1. **PMID:** 27814935 **Citation:** Suri SS, Pamboukian SV. Optimal diuretic strategies in heart failure. Ann Transl Med. 2021 Mar;9(6):517. doi: 10.21037/atm-20-4600. **PMID:** 33850914 **Citation:** McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available. Erratum In: Eur Heart J. 2021 Oct 14;: **PMID:** 34447992 **Citation:** Sica DA. Metolazone and its role in edema management. Congest Heart Fail. 2003 Mar-Apr;9(2):100-5. doi: 10.1111/j.1527-5299.2003.01907.x. **PMID:** 12671341 **Citation:** Cox ZL, Hung R, Lenihan DJ, Testani JM. Diuretic Strategies for Loop Diuretic Resistance in Acute Heart Failure: The 3T Trial. JACC Heart Fail. 2020 Mar;8(3):157-168. doi: 10.1016/j.jchf.2019.09.012. Epub 2019 Dec 11. **PMID:** 31838029 **Citation:** Verbrugge FH, Dupont M, Bertrand PB, Nijst P, Penders J, Dens J, Verhaert D, Vandervoort P, Tang WH, Mullens W. Determinants and impact of the natriuretic response to diuretic therapy in heart failure with reduced ejection fraction and volume overload. Acta Cardiol. 2015 Jun;70(3):265-73. doi: 10.1080/ac.70.3.3080630. **PMID:** 26226699 **Citation:** Verbrugge FH, Martens P, Ameloot K, Haemels V, Penders J, Dupont M, Tang WHW, Droogne W, Mullens W. Acetazolamide to increase natriuresis in congestive heart failure at high risk for diuretic resistance. Eur J Heart Fail. 2019 Nov;21(11):1415-1422. doi: 10.1002/ejhf.1478. Epub 2019 May 9. **PMID:** 31074184 **Citation:** Mullens W, Dauw J, Martens P, Verbrugge FH, Nijst P, Meekers E, Tartaglia K, Chenot F, Moubayed S, Dierckx R, Blouard P, Troisfontaines P, Derthoo D, Smolders W, Bruckers L, Droogne W, Ter Maaten JM, Damman K, Lassus J, Mebazaa A, Filippatos G, Ruschitzka F, Dupont M; ADVOR Study Group. Acetazolamide in Acute Decompensated Heart Failure with Volume Overload. N Engl J Med. 2022 Sep 29;387(13):1185-1195. doi: 10.1056/NEJMoa2203094. Epub 2022 Aug 27. **PMID:** 36027559 **Citation:** Mullens W, Damman K, Harjola VP, Mebazaa A, Brunner-La Rocca HP, Martens P, Testani JM, Tang WHW, Orso F, Rossignol P, Metra M, Filippatos G, Seferovic PM, Ruschitzka F, Coats AJ. The use of diuretics in heart failure with congestion - a position statement from the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2019 Feb;21(2):137-155. doi: 10.1002/ejhf.1369. Epub 2019 Jan 1. **PMID:** 30600580 **Citation:** Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available. **PMID:** 22890468 **Citation:** Jung B, Martinez M, Claessens YE, Darmon M, Klouche K, Lautrette A, Levraut J, Maury E, Oberlin M, Terzi N, Viglino D, Yordanov Y, Claret PG, Bige N; Societe de Reanimation de Langue Francaise (SRLF); Societe Francaise de Medecine d'Urgence (SFMU). Diagnosis and management of metabolic acidosis: guidelines from a French expert panel. Ann Intensive Care. 2019 Aug 15;9(1):92. doi: 10.1186/s13613-019-0563-2. **PMID:** 31418093 **Citation:** Kim HN, Januzzi JL Jr. Natriuretic peptide testing in heart failure. Circulation. 2011 May 10;123(18):2015-9. doi: 10.1161/CIRCULATIONAHA.110.979500. No abstract available. **PMID:** 21555724 **Citation:** Januzzi JL, van Kimmenade R, Lainchbury J, Bayes-Genis A, Ordonez-Llanos J, Santalo-Bel M, Pinto YM, Richards M. NT-proBNP testing for diagnosis and short-term prognosis in acute destabilized heart failure: an international pooled analysis of 1256 patients: the International Collaborative of NT-proBNP Study. Eur Heart J. 2006 Feb;27(3):330-7. doi: 10.1093/eurheartj/ehi631. Epub 2005 Nov 17. **PMID:** 16293638 **Citation:** Inker LA, Eneanya ND, Coresh J, Tighiouart H, Wang D, Sang Y, Crews DC, Doria A, Estrella MM, Froissart M, Grams ME, Greene T, Grubb A, Gudnason V, Gutierrez OM, Kalil R, Karger AB, Mauer M, Navis G, Nelson RG, Poggio ED, Rodby R, Rossing P, Rule AD, Selvin E, Seegmiller JC, Shlipak MG, Torres VE, Yang W, Ballew SH, Couture SJ, Powe NR, Levey AS; Chronic Kidney Disease Epidemiology Collaboration. New Creatinine- and Cystatin C-Based Equations to Estimate GFR without Race. N Engl J Med. 2021 Nov 4;385(19):1737-1749. doi: 10.1056/NEJMoa2102953. Epub 2021 Sep 23. **PMID:** 34554658 **Citation:** Ng TM, Konopka E, Hyderi AF, Hshieh S, Tsuji Y, Kim BJ, Han SY, Phan DH, Jeng AI, Lou M, Elkayam U. Comparison of bumetanide- and metolazone-based diuretic regimens to furosemide in acute heart failure. J Cardiovasc Pharmacol Ther. 2013 Jul;18(4):345-53. doi: 10.1177/1074248413482755. Epub 2013 Mar 27. **PMID:** 23538300 ## 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 - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9421 - Name: Heart Failure - Relevance: HIGH - As Found: Heart Failure - ID: M7657 - Name: Edema - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006333 - Term: Heart Failure ### Intervention Browse Module - Ancestors - ID: D000045283 - Term: Natriuretic Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000927 - Term: Anticonvulsants - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000000959 - Term: Antihypertensive Agents - ID: D000049993 - Term: Sodium Chloride Symporter Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: AnAg - Name: Antihypertensive Agents - Abbrev: NaAg - Name: Natriuretic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AntiConv - Name: Anticonvulsants ### Intervention Browse Module - Browse Leaves - ID: M11761 - Name: Metolazone - Relevance: HIGH - As Found: Endothelin - ID: M2536 - Name: Acetazolamide - Relevance: HIGH - As Found: Pain Control - ID: M7411 - Name: Diuretics - Relevance: HIGH - As Found: Hypoglycemia - ID: M5515 - Name: Carbonic Anhydrase Inhibitors - Relevance: HIGH - As Found: Starts during - ID: M1912 - Name: Torsemide - Relevance: LOW - As Found: Unknown - ID: M8784 - Name: Furosemide - Relevance: LOW - As Found: Unknown - ID: M5306 - Name: Bumetanide - Relevance: LOW - As Found: Unknown - ID: M26153 - Name: Sodium Potassium Chloride Symporter Inhibitors - Relevance: HIGH - As Found: Duo - ID: M4246 - Name: Anticonvulsants - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4277 - Name: Antihypertensive Agents - Relevance: LOW - As Found: Unknown - ID: M26152 - Name: Sodium Chloride Symporter Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000008788 - Term: Metolazone - ID: D000000086 - Term: Acetazolamide - ID: D000004232 - Term: Diuretics - ID: D000002257 - Term: Carbonic Anhydrase Inhibitors - ID: D000049994 - Term: Sodium Potassium Chloride Symporter Inhibitors ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414746 **Acronym:** LOCUS **Brief Title:** Hereditary Transthyretin Amyloidosis Polyneuropathy in Patients With Carpal Tunnel Syndrome in Russia **Official Title:** A Multicenter Observational Retrospective-prospective Study of Prevalence, Clinical Characteristics of Hereditary Transthyretin Amyloidosis Polyneuropathy in Russian Patients Undergoing Surgery for CTS in Real Clinical Practice #### Organization Study ID Info **ID:** D8451R00001 #### Organization **Class:** INDUSTRY **Full Name:** AstraZeneca ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **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:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-02-16 **Study First Submit QC Date:** 2024-05-13 ### 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 multicenter observational study consisting of retrospective and prospective phases. The retrospective phase will entail secondary data collection from electronic or paper medical records of patients who underwent surgery for CTS to assess their probability of having ATTR PN. **Detailed Description:** ATTR PN is a genotypically, phenotypically and geographically variable disease with a poor prognosis, albeit available disease-modifying drugs can change the disease trajectory. Thus country-specific epidemiologic data collection and identification of early stage PN, including previously misdiagnosed patients, is crucial to improve outcomes and quality of life. However, no observational studies on the epidemiology of ATTR PN in the whole Russian population, or in patients with CTS, have been performed. Therefore, there is a need to conduct a large-scale observational study to determine the prevalence of ATTR PN in Russia, obtain information on patients' clinical characteristics, and determine their medical needs. The approaches to diagnosis of ATTR PN in Russia over the past few years have been characterized by the use of heterogenous methods, partially explained by the lack of availability of molecular genetic testing, which is essential to diagnose the presence of pathogenic mutation in patients with hereditary ATTR PN. Thus, recent introduction of such tests into routine clinical practice may allow to assess reliable epidemiologic data including estimation of true ATTR PN prevalence among patients with CTS, which can often be the first manifestation of the disease. Earlier recognition, in turn, may lead to timely treatment initiation and change in the prognostic outlook of ATTR PN patients. In order to assess the prevalence of ATTR PN in patients undergoing surgery for CTS in Russia this study will retrospectively include patients with the diagnosis of CTS undergoing surgery between the 1st January 2021 and the 1st September 2024. Suspicion of ATTR PN will be assessed in each case, and diagnostic tests (comprehensive neurological examination including nerve conduction study (NCS) combined with molecular genetic testing) to confirm or exclude the disease will be conducted prospectively in eligible patients. In addition to that, clinical features, concomitant manifestations, and diagnosed genotypes will be analyzed to examine characteristic ATTR PN patient profiles in the Russian Federation. ### Conditions Module **Conditions:** - Hereditary Transthyretin Amyloidosis - Carpal Tunnel Syndrome - Polyneuropathy - Amyloidosis **Keywords:** - ATTR PN - CTS - PN - carpal tunnel syndrome - polyneuropathy - amyloidosis ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 880 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** In order to achieve primary objective, the proportion of patients with confirmed diagnosis of ATTR PN (presence of TTR gene mutation according to the results of molecular genetic testing and clinical symptoms and/or signs of polyneuropathy) among those who underwent surgery for CTS will be calculated. **Measure:** To define the prevalence of ATTR PN in patients undergoing surgery for CTS in routine clinical practice in the Russian Federation **Time Frame:** Up to 12 months #### Secondary Outcomes **Measure:** To assess general demographic characteristics of patients with ATTR PN in Russia - Mean age (years) at the onset of CTS symptoms **Time Frame:** up to 12 months **Measure:** To assess general demographic characteristics of patients with ATTR PN in Russia: Mean age (years) at the onset of polyneuropathy symptoms **Time Frame:** up to 12 months **Measure:** to assess general demographic characteristics of patients with ATTR PN in Russia: Proportion of patients with late (>50 years) diagnosis of ATTR PN **Time Frame:** up to 12 months **Measure:** to assess general demographic characteristics of patients with ATTR PN in Russia: Mean age (years) at the time of CTS surgery **Time Frame:** up to 12 months **Description:** 1. Left hand; 2. Right hand; 3. Both hands; 4. First procedure; 5. Second and later procedures **Measure:** to assess general demographic and clinical characteristics of patients with ATTR PN in Russia - Number and proportion of patients with specific characteristic of index CTS download **Time Frame:** up to 12 months **Measure:** to assess general demographic and clinical characteristics of patients with ATTR PN in Russia: Proportion of patients with CTS recurrence after surgery **Time Frame:** up to 12 months **Measure:** to assess general demographic and clinical characteristics of patients with ATTR PN in Russia: Proportion of patients undergoing repeat surgery for CTS after the index operation **Time Frame:** up to 12 months **Measure:** to assess general demographic and clinical characteristics of patients with ATTR PN in Russia: Proportion of patients with PN progression after surgery **Time Frame:** up to 12 months **Description:** 1. 1 red flag; 2. 2 red flags; 3. 3 red flags; 4. 4-5 red flags; 5. 6-10 red flags; 6. \>10 red flags; **Measure:** to assess general demographic and clinical characteristics of patients with ATTR PN in Russia - Proportion of patients with different number of red flags: **Time Frame:** up to 12 months **Measure:** to assess general demographic and clinical characteristics of patients with ATTR PN in Russia: Mean age (years) at ATTR PN diagnosis **Time Frame:** up to 12 months **Measure:** to assess general demographic and clinical characteristics of patients with ATTR PN in Russia: Proportion of women and men **Time Frame:** up to 12 months **Description:** 1. Underweight (BMI \<18.5 kg/m2); 2. Normal weight (BMI ≥18.5 and \<25 kg/m2); 3. Overweight (BMI ≥25 and \<30 kg/m2); 4. Obesity (BMI ≥30 kg/m2) **Measure:** to assess general demographic and clinical characteristics of patients with ATTR PN in Russia - Mean body mass index (BMI) and proportion of patients with different BMI dimensions at the time of surgery and at Visit 1: **Time Frame:** up to 12 months **Measure:** to assess general demographic and clinical characteristics of patients with ATTR PN in Russia: Proportion of patients with a history of unexplained weight loss (≥5 kg) at any point since symptom onset **Time Frame:** up to 12 months **Measure:** to assess general demographic and clinical characteristics of patients with ATTR PN in Russia: Mean and median time from CTS symptom onset (months) to ATTR PN diagnosis **Time Frame:** up to 12 months **Measure:** To assess general demographic and clinical characteristics of patients with ATTR PN in Russia: Median number of physicians seen since symptom onset before the correct ATTR PN diagnosis **Time Frame:** up to 12 months **Measure:** To assess general demographic and clinical characteristics of patients with ATTR PN in Russia: Median number of hospitalizations for PN before the correct ATTR PN diagnosis **Time Frame:** up to 12 months **Description:** 1. CIDP; 2. Lumbar/sacral radiculopathy; 3. Lumbar canal stenosis; 4. Paraproteinaemic peripheral neuropathy; 5. Chronic progressive sensory/sensorimotor axonal idiopathic PN; 6. AL amyloidosis; 7. Fibromyalgia; 8. Other (specify) **Measure:** to assess general demographic and clinical characteristics of patients with ATTR PN in Russia - Number of patients with previously established incorrect diagnosis according to medical records, specifically with: **Time Frame:** up to 12 months **Measure:** To describe data on the presence of cardiovascular, neurological and other comorbidities in Russian patients with ATTR PN: Proportion of patients with family history of neuropathic disease **Time Frame:** up to 12 months **Description:** 1. Neuropathic pain (allodynia, hyperalgesia); 2. Progressive sensory disturbances (loss of temperature, pain, other sensation); 3. Paresthesia, dysesthesia; 4. Progressive motor disturbances; 5. Walking difficulty, gait disorder; 6. Balance disorder **Measure:** To describe data on the presence of cardiovascular, neurological and other comorbidities in Russian patients with ATTR PN: Proportion of patients with specific peripheral neurological manifestations: **Time Frame:** up to 12 months **Description:** 1. 0; 2. I; 3. II; 4. IIIA; 5. IIIB; 6. IV; **Measure:** To describe data on the presence of cardiovascular, neurological and other comorbidities in Russian patients with ATTR PN: Proportion of patients with specific Polyneuropathy Disability (PND) classes: **Time Frame:** up to 12 months **Description:** 1. Upper-limb; 2. Lower-limb; 3. Both upper-limb and lower-limb **Measure:** To describe data on the presence of cardiovascular, neurological and other comorbidities in Russian patients with ATTR PN - Proportion of patients with specific distribution of polyneuropathy symptoms: **Time Frame:** up to 12 months **Description:** 1. Orthostatic hypotension; 2. Syncope; 3. Gastrointestinal motility disorders - i. Constipation; ii. Early satiety; iii. Diarrhea; iv. Nausea, vomiting; 4. Erectile dysfunction; 5. Neurogenic bladder; 6. Recurrent urinary infections; 7. Anhidrosis; **Measure:** To describe data on the presence of cardiovascular, neurological and other comorbidities in Russian patients with ATTR PN - Number of patients with autonomic neurological manifestations, including specifically: **Time Frame:** up to 12 months **Description:** 1. Left ventricular hypertrophy; 2. Left bundle branch block; 3. Atrioventricular block; 4. Heart failure with preserved ejection fraction; 5. Elevated serum N-terminal-proB-type natriuretic peptide (NT-proBNP) concentration; 6. Cardiac valve stenosis; 7. Cardiac valve regurgitation; 8. Tachyarrhythmia; 9. Other (specify); 10. None; **Measure:** To describe data on the presence of cardiovascular, neurological and other comorbidities in Russian patients with ATTR PN - Number of patients with concomitant cardiac manifestations, including specifically: **Time Frame:** up to 12 months **Description:** 1. Angiotensin converting enzyme inhibitor (ACEI) (specify); 2. Angiotensin receptor blocker (ARB) (specify); 3. Angiotensin receptor and neprilysin inhibitor (ARNI); 4. Sodium-glucose transporter type 2 inhibitor (SGLT2i) (specify); 5. Mineralocorticoid receptor antagonist (MRA) (specify); 6. Beta-blocker (specify); 7. Diuretic (specify); 8. Other cardiovascular (CV) medications (specify); 9. Other (specify); **Measure:** Number of patients taking specific groups of cardiovascular medications at the time of CTS surgery and at the time of prospective visit: **Time Frame:** up to 12 months **Description:** 1. Vitreous body inclusions (opacification); 2. Glaucoma; 3. Abnormal conjunctival vessels; 4. Papillary abnormalities; 5. Dry eye; 6. Other (specify); **Measure:** To describe data on the presence of cardiovascular, neurological and other comorbidities in Russian patients with ATTR PN - Number of patients with concomitant ophthalmologic manifestations, including specifically **Time Frame:** up to 12 months **Description:** 1. Spinal stenosis; 2. Osteoarthritis, including hip and knee arthroplasty; 3. Trigger finger; 4. Charcot's joints; 5. Biceps tendon rupture; 6. Rotator cuff injury; 7. Other (specify); **Measure:** To describe data on the presence of cardiovascular, neurological and other comorbidities in Russian patients with ATTR PN - Number of patients with concomitant musculoskeletal manifestations, including specifically: **Time Frame:** up to 12 months **Measure:** Mean and median serum NT-proBNP (pg/ml) concentration **Time Frame:** up to 12 months **Measure:** Proportion of patients with laboratory confirmed paraproteinemia **Time Frame:** up to 12 months **Measure:** Mean and median urine albumin-creatinine ratio (UACR, mg/g of creatinine) **Time Frame:** up to 12 months **Description:** 1. Stage C1; 2. Stage C2; 3. Stage C3a; 4. Stage C3b; 5. Stage C4; 6. Stage C5; **Measure:** Proportion of patients with diagnosed CKD, including specifically **Time Frame:** up to 12 months **Description:** 1. Elevated SCr level (based on the local laboratory reference range); 2. Decreased eGFR (\<60 ml/min/1.73m2); 3. Presence of albuminuria (≥30 mg/g creatinine (≥30 mg/g of creatinine or ≥30 mg/24h); 4. Presence of proteinuria (according to urinalysis results); 5. Ultrasound signs of amyloid nephropathy; **Measure:** Number of patients with concomitant renal dysfunction, including specifically **Time Frame:** up to 12 months **Measure:** Number of patients with confirmed length-dependent peripheral sensory-motor neuropathy based on NCS results **Time Frame:** up to 12 months **Description:** 1. Left Medial; 2. Left Ulnar; 3. Left Sural; 4. Right Medial; 5. Right Ulnar; 6. Right Sural; **Measure:** Mean and median measured peripheral sensory nerve conduction velocities **Time Frame:** up to 12 months **Measure:** Number of patients with reduced peripheral sensory nerve conduction velocity at ≥1 site **Time Frame:** up to 12 months **Description:** 1. Left Medial; 2. Left Ulnar; 3. Left Tibial; 4. Left Peroneal; 5. Right Medial; 6. Right Ulnar; 7. Right Tibial; 8. Right Peroneal; **Measure:** Mean and median measured peripheral motor nerve conduction velocities **Time Frame:** up to 12 months **Measure:** Number of patients with reduced motor sensory nerve conduction velocity at ≥1 site **Time Frame:** up to 12 months **Description:** 1. Left Medial; 2. Left Ulnar; 3. Left Sural; 4. Right Medial; 5. Right Ulnar; 6. Right Sural **Measure:** Mean and median measured sensory action potential (SAP) amplitudes **Time Frame:** up to 12 months **Measure:** Number of patients with reduced/absent SAP amplitude at ≥1 site **Time Frame:** up to 12 months **Description:** 1. Left Medial; 2. Left Ulnar; 3. Left Tibial; 4. Left Peroneal; 5. Right Medial; 6. Right Ulnar; 7. Right Tibial; 8. Right Peroneal **Measure:** Mean and median measured distal compound muscle action potential (dCMAP) amplitudes **Time Frame:** up to 12 months **Description:** 1. Left Medial; 2. Left Ulnar; 3. Left Tibial; 4. Left Peroneal; 5. Right Medial; 6. Right Ulnar; 7. Right Tibial; 8. Right Peroneal **Measure:** Mean and median measured proximal compound muscle action potential (pCMAP) amplitudes **Time Frame:** up to 12 months **Measure:** Number of patients with reduced/absent dCMAP amplitude at ≥1 site **Time Frame:** up to 12 months **Measure:** Number of patients with reduced/absent pCMAP amplitude at ≥1 site **Time Frame:** up to 12 months **Measure:** Proportion of patients with each score by each parameter of neurological examination **Time Frame:** up to 12 months **Description:** 1. Score 1 (no significant disability); 2. Score 2 (slight disability); 3. Score 3 (moderate disability); 4. Score 4 (moderately severe disability); 5. Score 5 (severe disability); **Measure:** Number of patients in the specific categories of the modified Rankin scale **Time Frame:** up to 12 months **Description:** 1. 0 points; 2. 1 point; 3. 2 points; 4. 3 points; 5. 4 points; 6. 5 points **Measure:** Proportion of patients with specific number of points according to Inflammatory Neuropathy Cause and Treatment (INCAT) upper extremity scale **Time Frame:** up to 12 months **Measure:** Median number of points according to INCAT upper extremity scale **Time Frame:** up to 12 months **Description:** 1. 0 points; 2. 1 point; 3. 2 points; 4. 3 points; 5. 4 points; 6. 5 points **Measure:** Proportion of patients with specific number of points according to INCAT lower extremity scale **Time Frame:** up to 12 months **Measure:** Median number of points according to INCAT lower extremity scale **Time Frame:** up to 12 months **Measure:** Mean and median number of points according to combined clinical and electrophysiological score **Time Frame:** up to 12 months **Description:** 1. Val30Met; 2. Ile107Val; 3. Phe33Leu; 4. Ala81Val; 5. Ser23Asn; 6. Ala25Thr; 7. Val32Ala; 8. Thr40Asn; 9. Gly47Ala; 10. Glu54Gln; 11. Tyr69Phe; 12. Glu92Lys; 13. Thr119Met; 14. Other **Measure:** To describe data on the results of genetic testing for ATTR in CTS patients undergoing surgery:Number and proportion of patients with specific TTR gene mutations **Time Frame:** up to 12 months **Description:** 1. CIDP; 2. Lumbar/sacral radiculopathy; 3. Lumbar canal stenosis; 4. Paraproteinaemic peripheral neuropathy; 5. Chronic progressive sensory/sensorimotor axonal idiopathic PN; 6. AL amyloidosis; 7. Fibromyalgia; 8. Other (specify); **Measure:** to assess general demographic and clinical characteristics of patients with ATTR PN in Russia - Proportion of patients with previously established incorrect diagnosis according to medical records, specifically with: **Time Frame:** up to 12 months **Description:** manifestations, including specifically: 1. Orthostatic hypotension; 2. Syncope; 3. Gastrointestinal motility disorders - i. Constipation; ii. Early satiety; iii. Diarrhea; iv. Nausea, vomiting; 4. Erectile dysfunction; 5. Neurogenic bladder; 6. Recurrent urinary infections; 7. Anhidrosis; **Measure:** To describe data on the presence of cardiovascular, neurological and other comorbidities in Russian patients with ATTR PN - proportion of patients with autonomic neurological manifestations, including specifically: **Time Frame:** up to 12 months **Description:** 1. Left ventricular hypertrophy; 2. Left bundle branch block; 3. Atrioventricular block; 4. Heart failure with preserved ejection fraction; 5. Elevated serum N-terminal-proB-type natriuretic peptide (NT-proBNP) concentration; 6. Cardiac valve stenosis; 7. Cardiac valve regurgitation; 8. Tachyarrhythmia; 9. Other (specify); 10. None; **Measure:** To describe data on the presence of cardiovascular, neurological and other comorbidities in Russian patients with ATTR PN - proportion of patients with concomitant cardiac manifestations, including specifically: **Time Frame:** up to 12 months **Description:** 1. Angiotensin converting enzyme inhibitor (ACEI) (specify); 2. Angiotensin receptor blocker (ARB) (specify); 3. Angiotensin receptor and neprilysin inhibitor (ARNI); 4. Sodium-glucose transporter type 2 inhibitor (SGLT2i) (specify); 5. Mineralocorticoid receptor antagonist (MRA) (specify); 6. Beta-blocker (specify); 7. Diuretic (specify); 8. Other cardiovascular (CV) medications (specify); 9. Other (specify); **Measure:** proportion of patients taking specific groups of cardiovascular medications at the time of CTS surgery and at the time of prospective visit: **Time Frame:** up to 12 months **Description:** 1. Vitreous body inclusions (opacification); 2. Glaucoma; 3. Abnormal conjunctival vessels; 4. Papillary abnormalities; 5. Dry eye; 6. Other (specify); **Measure:** To describe data on the presence of cardiovascular, neurological and other comorbidities in Russian patients with ATTR PN - proportion of patients with concomitant ophthalmologic manifestations, including specifically **Time Frame:** up to 12 months **Description:** 1. Spinal stenosis; 2. Osteoarthritis, including hip and knee arthroplasty; 3. Trigger finger; 4. Charcot's joints; 5. Biceps tendon rupture; 6. Rotator cuff injury; 7. Other (specify); **Measure:** To describe data on the presence of cardiovascular, neurological and other comorbidities in Russian patients with ATTR PN - proportion of patients with concomitant musculoskeletal manifestations, including specifically: **Time Frame:** up to 12 months **Description:** 1. Elevated SCr level (based on the local laboratory reference range); 2. Decreased eGFR (\<60 ml/min/1.73m2); 3. Presence of albuminuria (≥30 mg/g creatinine (≥30 mg/g of creatinine or ≥30 mg/24h); 4. Presence of proteinuria (according to urinalysis results); 5. Ultrasound signs of amyloid nephropathy; **Measure:** proportion of patients with concomitant renal dysfunction, including specifically **Time Frame:** up to 12 months **Measure:** proportion of patients with confirmed length-dependent peripheral sensory-motor neuropathy based on NCS results **Time Frame:** up to 12 months **Measure:** proportion of patients with reduced peripheral sensory nerve conduction velocity at ≥1 site **Time Frame:** up to 12 months **Measure:** proportion of patients with reduced motor sensory nerve conduction velocity at ≥1 site **Time Frame:** up to 12 months **Measure:** proportion of patients with reduced/absent SAP amplitude at ≥1 site **Time Frame:** up to 12 months **Measure:** proportion of patients with reduced/absent dCMAP amplitude at ≥1 site **Time Frame:** up to 12 months **Measure:** proportion of patients with reduced/absent pCMAP amplitude at ≥1 site **Time Frame:** up to 12 months **Description:** -a) Score 1 (no significant disability); b) Score 2 (slight disability); c) Score 3 (moderate disability); d) Score 4 (moderately severe disability); e) Score 5 (severe disability **Measure:** proportion of patients in the specific categories of the modified Rankin scale **Time Frame:** up to 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: for the retrospective phase are: 1. Patients with the established diagnosis of CTS undergoing surgical intervention between the 1st January 2021 and the 1st September 2024. 2. Age ≥ 18 years at the time of surgery. Additional inclusion criteria for the prospective phase are: 3. Provided written informed consent for the prospective phase of the study (including molecular genetic testing). 4. Bilateral CTS; 5. Presence of ≥1 of the following features (red flags): 1. CIDP or polyneuropathy of unknown etiology in the family history; 2. Spinal canal stenosis of the lumbar region; 3. Autonomic dysfunction, defined by the presence of ≥1 of the following symptoms: i. gastrointestinal complaints (constipation, chronic diarrhea, or both); ii. erectile dysfunction; iii. orthostatic hypotension; 4. Gait disorders; 5. Sweating disorders, anhidrosis. 6. Paresthesia and burning of the skin of the distal extremities 7. Distal symmetrical paresis 8. Hypotrophy and hypotension of limb muscles, areflexia 9. Biceps tendon rupture 10. Aortic valve stenosis 11. Diagnosis of HFpEF 12. Unexplained weight loss ≥5 kilos at any timepoint since the onset of symptoms of CTS; 13. Left ventricular hypertrophy (based on electro- or echocardiographic criteria documented in the patient's medical record); 14. Heart rhythm disorders; 15. Renal abnormalities, defined by ≥1 of the following features - i. documented diagnosis of chronic kidney disease (CKD); ii. decreased estimated glomerular filtration rate (eGFR \<60 mL/min/1.73m2); iii. increased serum creatinine (SCr) above reference range of the local laboratory; iv. albuminuria (≥30 mg/g of creatinine or ≥30 mg/24h ); v. proteinuria (according to urinalysis results). 16. Ophthalmology disorder defined by ≥1 of the following features - i. vitreous body inclusions (opacification); ii. Glaucoma; iii. pupillary disorders; iv. vitrectomy 6. Absence of previously established ATTR PN diagnosis (ICD-10 code Е85.1, "Neuropathic hereditary familial amyloidosis"). Exclusion Criteria: for the retrospective phase are: 1. Participation in any interventional trial within the period since surgical intervention until the end of current study. Additional exclusion criteria for the prospective phase are: 2. Previously performed TTR genetic testing; 3. Verified B12 deficiency; 4. History of alcohol abuse according to the patient's medical record. **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** This multicenter observational study will retrospectively include 4400 consecutive adult patients who underwent surgery for CTS in Russia, including approximately \~880 patients with CTS and high suspicion of having ATTR PN who will be enrolled in the prospective phase. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** information.center@astrazeneca.com **Name:** AstraZeneca Clinical Study Information Center **Phone:** 1-877-240-9479 **Role:** CONTACT #### Locations **Location 1:** **City:** Moscow **Country:** Russian Federation **Facility:** Research Site **Status:** RECRUITING **Location 2:** **City:** Saint-Petersburg **Country:** Russian Federation **Facility:** Research Site **Status:** RECRUITING **Zip:** 194354 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000057165 - Term: Proteostasis Deficiencies - ID: D000008659 - Term: Metabolic Diseases - ID: D000020423 - Term: Median Neuropathy - ID: D000020422 - Term: Mononeuropathies - ID: D000010523 - Term: Peripheral Nervous System Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009408 - Term: Nerve Compression Syndromes - ID: D000012090 - Term: Cumulative Trauma Disorders - ID: D000013180 - Term: Sprains and Strains - ID: D000014947 - Term: Wounds and Injuries - ID: D000020271 - Term: Heredodegenerative Disorders, Nervous System - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000028226 - Term: Amyloidosis, Familial - ID: D000008661 - Term: Metabolism, Inborn Errors ### 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: BC26 - Name: Wounds and Injuries - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M4021 - Name: Amyloidosis - Relevance: HIGH - As Found: Amyloidosis - ID: M13999 - Name: Polyneuropathies - Relevance: HIGH - As Found: Polyneuropathy - ID: M5603 - Name: Carpal Tunnel Syndrome - Relevance: HIGH - As Found: Carpal Tunnel Syndrome - ID: M19981 - Name: Amyloid Neuropathies - Relevance: HIGH - As Found: Amyloidosis Polyneuropathy - ID: M23330 - Name: Amyloid Neuropathies, Familial - Relevance: HIGH - As Found: Hereditary Transthyretin Amyloidosis - ID: M28747 - Name: Proteostasis Deficiencies - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M22219 - Name: Median Neuropathy - Relevance: LOW - As Found: Unknown - ID: M22218 - Name: Mononeuropathies - Relevance: LOW - As Found: Unknown - ID: M13432 - Name: Peripheral Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12352 - Name: Nerve Compression Syndromes - Relevance: LOW - As Found: Unknown - ID: M5853 - Name: Charcot-Marie-Tooth Disease - Relevance: LOW - As Found: Unknown - ID: M18092 - Name: Hereditary Sensory and Motor Neuropathy - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M14930 - Name: Cumulative Trauma Disorders - Relevance: LOW - As Found: Unknown - ID: M15974 - Name: Sprains and Strains - Relevance: LOW - As Found: Unknown - ID: M22092 - Name: Heredodegenerative Disorders, Nervous System - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M23329 - Name: Amyloidosis, Familial - Relevance: LOW - As Found: Unknown - ID: M11641 - Name: Metabolism, Inborn Errors - Relevance: LOW - As Found: Unknown - ID: T2264 - Name: Familial Transthyretin Amyloidosis - Relevance: HIGH - As Found: Transthyretin Amyloidosis - ID: T340 - Name: Amyloid Neuropathy - Relevance: HIGH - As Found: Amyloidosis Polyneuropathy - ID: T1081 - Name: Charcot-Marie-Tooth Disease - Relevance: LOW - As Found: Unknown - ID: T2761 - Name: Hereditary Motor and Sensory Neuropathy - Relevance: LOW - As Found: Unknown - ID: T2766 - Name: Hereditary Neuropathy With Liability to Pressure Palsies - Relevance: LOW - As Found: Unknown - ID: T5067 - Name: Roussy Levy Syndrome - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002349 - Term: Carpal Tunnel Syndrome - ID: D000011115 - Term: Polyneuropathies - ID: D000028227 - Term: Amyloid Neuropathies, Familial - ID: D000017772 - Term: Amyloid Neuropathies - ID: D000000686 - Term: Amyloidosis - ID: D000013577 - Term: Syndrome ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414733 **Brief Title:** Vaccine Therapy in Treating Patients With Metastatic Solid Tumors **Official Title:** Phase Ib Active Immunotherapy Trial (Expansion) With a Combination of Two Chimeric (Trastuzumab-like and Pertuzumab-like) HER-2 B Cell Peptide Vaccine Emulsified in ISA 720 Adjuvant in Patients With Advanced Solid Tumors #### Organization Study ID Info **ID:** CTO-IUSCCC-09138 #### Organization **Class:** OTHER **Full Name:** Indiana University ### Status Module #### Completion Date **Date:** 2027-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Pravin T.P Kaumaya #### Responsible Party **Investigator Affiliation:** Indiana University **Investigator Full Name:** Pravin T.P Kaumaya **Investigator Title:** The Vera Bradley Foundation Endowed Chair in Breast Cancer Innovation **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with metastatic solid tumors. Vaccines made from antibodies and peptides combined with tumor cells may help the body build an effective immune response to kill tumor cells. ### Conditions Module **Conditions:** - Metastatic Breast Cancer - Metastatic Gastrointestinal Carcinoma - HER2-positive Breast Cancer - HER2-positive Gastric Cancer - EGFR Overexpression **Keywords:** - Phase I - Breast Cancer - GI Cancer ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 42 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Biological: Combination of MVF-HER-2 (597-626) and MVF-HER-2 (266-296) emulsified with ISA 720 **Label:** HER-2 vaccine Breast **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Biological: Combination of MVF-HER-2 (597-626) and MVF-HER-2 (266-296) emulsified with ISA 720 **Label:** HER-2 vaccine GI **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - HER-2 vaccine Breast - HER-2 vaccine GI **Description:** Three intramuscular (IM) injections (separated by 21 days) of a mixture of two peptides {MVF-HER-2(597-626) and MVF-HER-2 (266-296)} vaccine emulsified in ISA 720 vehicle. The combined vaccine preparation consists of 1.5mg of each of the HER-2 vaccine emulsified with a Montanide ISA 720, and will be administered in a final volume of 1.0 ml. Patients may also receive 6 months booster shots. **Name:** Combination of MVF-HER-2 (597-626) and MVF-HER-2 (266-296) emulsified with ISA 720 **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Measure:** Evaluation of safety and toxicity at regular intervals by NCI common toxicity criteria 5.0 **Time Frame:** through study completion (i.e. up to 1 year post initial vaccine) **Description:** Humoral immune response will be measured by ELISA quantification of IgM and IgG antibodies to HER2 (597-626) and HER2 (266-296) **Measure:** Humoral Immune Response **Time Frame:** through completion of 3 vaccine series (i.e. up to day 92 post final vaccine injection) **Measure:** Overall Response Rate **Time Frame:** through completion of 3 vaccine series (i.e. up to day 71) #### Secondary Outcomes **Description:** ELISA will be analyzed for immunogenicity at baseline, with every vaccine, 21 days after the final vaccine, 6 months from initial vaccination, and at 1 year from initial vaccination to describe time course of antibody production **Measure:** immunogenicity **Time Frame:** through study completion (i.e. up to 1 year post initial vaccine) **Description:** T cell functionality will be determined using proteomic profiling and immunophenotyping **Measure:** T cell functionality **Time Frame:** through study completion (i.e. up to 1 year post initial vaccine) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Inclusion Criteria for Extension and Expansion Cohorts 1. For the extension cohort to be conducted at the IUSCCC (N=12), patients with histologically documented metastatic or unresectable breast or gastrointestinal cancer will be enrolled. 2. For the expansion cohort (N=30), patients with either histologically documented metastatic or unresectable breast cancer (N=15), or histologically documented metastatic or unresectable gastrointestinal cancer (N=15) be enrolled. All patients enrolled to this cohort are required to have measurable disease. Note: Measurable disease is defined as ≥ 1 lesions that can be accurately measured in ≥ 1 dimensions as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan. Inclusion Criteria for all Cohorts: 3. Patients must have received or refused first line standard systemic therapy for their metastases (if applicable) and patients with histologically confirmed pancreatic and esophageal cancers must have received no more than two prior cytotoxic chemotherapy regimens in the last two years after standard therapy. Patients with histologically confirmed breast, and gastrointestinal cancers must have received no more than three prior cytotoxic chemotherapy regimens in the last two years after standard therapy. 4. Progressive disease after at least one line of standard therapy. 5. Patients with pancreatic and esophageal cancers must have received no more than two prior cytotoxic chemotherapy regimens in the last two years. Patients with breast and gastrointestinal cancers must have received no more than three prior cytotoxic chemotherapy regimens in the last two years. 6. Patients are required to have HER-2 (IHC 1+, 2+ and 3+) or EGFR over-expression (FISH and IHC) to be enrolled on this study. 1. If the patient has had HER-2 expression measured prior to enrollment, the report alone will be accepted on the expansion phase of the study. 2. If the patient has had EGFR expression measured prior to enrollment, the report alone will be accepted on the dose escalation phase of the study. 3. If the patient has not had HER-2 or EGFR expression measured prior to enrollment on this study, it would be obligatory for the patient to have the tests performed to justify their status. HER-2 status can be performed by a variety of tests. Either IHC or FISH assay are acceptable if breast tumor tissues (previously frozen) are available. The test can be done at OSU or elsewhere if the patient is from out of town. 7. Patients with prior history of treated brain metastases who are off steroids and have stable metastatic brain disease for at least 3 months are eligible. 8. Patients must be ambulatory with an ECOG performance status 0, 1, or 2 (appendix II). 9. Patients must have adequate organ function as defined by: 1. ANC ≥ 1,000/mm³, platelet count \> 100,000/mm³. 2. Serum bilirubin \< 1.5 mg%, regardless of whether patients have liver involvement secondary to tumor. ALT must be \< 2 times upper limit of normal. 3. Creatinine \<1.5 mg/dl or calculated creatinine clearance \> 60 ml/min 10. Patients must be at least 3 weeks past any prior surgery, cytotoxic, chemotherapy, other immunotherapy, hormonal therapy, or radiation therapy. Patients having been treated with monoclonal antibodies may enter the trial after a specified period of time (2 times the mean half life of the agent). Patients must have recovered from any toxicity of prior therapy prior to enrolling on study except for neuropathy where patients need to recover to less than grade 2. 1. Patients with hormone receptor positive breast cancer who are on stable endocrine therapy are eligible if their tumor has some expression of HER-2 based on IHC of 1+ or 2+. 11. Patients must be at least 18 years of age. 12. Women of child-bearing potential must not be pregnant and must have a negative pregnancy test (Women of childbearing potential definition: (ECOG definition)). 13. Men and women must agree to practice effective contraception while on this study. 14. Patients must obtain a base line Echocardiogram or MUGA and require the left ventricular ejection fraction to be within normal limits (or 50% or higher). 15. Ability to understand and the willingness to sign a written informed consent document. The patient must be aware that his/her disease is neoplastic in nature and willingly consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts. Exclusion Criteria: 1. Patients with tumors that are negative for HER-2 expression based on IHC of 0 AND Fluorescence in-situ hybridization showing lack of HER-2 amplification based on most recent ASCO/CAP guidelines; or are under-expressing EGFR based on FISH and IHC. 2. Patients on targeted therapies, such as Cycline Dependent Kinase (CDK) 4/6 or mammalian target of rapamycin (mTOR) inhibitors in combination with endocrine therapy 3. Patients who are {MVF-HER-2(266-296) and MVF-HER-2 (597-626)} immediate hypersensitivity skin test positive. 4. Patients who have evidence of active infection that requires antibiotic therapy. Patients must have been off antibiotic treatment for at least 3 weeks prior to initiating treatment and must be confirmed to be clear of the infection. 5. Patients with known active HIV, hepatitis A, hepatitis B, or hepatitis C infection. 6. Patients with serious uncontrolled cardiopulmonary disorders, including congestive heart failure, symptomatic coronary artery disease, serious cardiac arrhythmia, and symptomatic chronic obstructive pulmonary disease or patients with other serious uncontrolled medical diseases. At the discretion of the treating physician, patients who show disease control for at least 6 months may be enrolled. 7. Patients who require or likely to require corticosteroids or other immunosuppressives for intercurrent disease are NOT eligible. 8. Splenectomized patients. 9. Patients with active autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis dermato-myositis, or a vasculitic syndrome. Note: At the discretion of the treating physician, patients who show disease control for at least 6 months may be enrolled. 10. Patients who have developed anaphylactic responses to other vaccines **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** zhongx@iu.edu **Name:** Xin Bryan, RN **Phone:** 317-274-5495 **Role:** CONTACT #### Locations **Location 1:** **City:** Indianapolis **Contacts:** ***Contact 1:*** - **Email:** zhongx@iu.edu - **Name:** Xin Bryan, RN - **Phone:** 317-274-5495 - **Role:** CONTACT ***Contact 2:*** - **Name:** Kathy Miller, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Indiana University Melvin & Bren Simon Comprehensive Cancer Center **State:** Indiana **Zip:** 46202 #### Overall Officials **Official 1:** **Affiliation:** Indiana University **Name:** Pravin Kaumaya, PhD **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 ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M16064 - Name: Stomach Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: T5486 - Name: Stomach Cancer - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents ### Intervention Browse Module - Browse Leaves - ID: M17360 - Name: Vaccines - Relevance: LOW - As Found: Unknown - ID: M325 - Name: Trastuzumab - Relevance: LOW - As Found: Unknown - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: M289243 - Name: Pertuzumab - Relevance: LOW - As Found: Unknown - ID: M254598 - Name: Monatide (IMS 3015) - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414720 **Acronym:** ENDOmiRNA **Brief Title:** Salivary microRNA in Endometriosis: Correlation With Response to Progestin Therapy **Official Title:** Salivary MicroRNA in Endometriosis: Correlation With Progestin Treatment Response: A Prospective Observational Study #### Organization Study ID Info **ID:** ENDOmiRNA #### Organization **Class:** OTHER **Full Name:** University of Udine ### Status Module #### Completion Date **Date:** 2025-05-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-01-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-22 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-05 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Udine #### Responsible Party **Investigator Affiliation:** University of Udine **Investigator Full Name:** Giuseppe Vizzielli **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study aims to analyze the salivary miRNA specific for patients diagnosed with endometriosis, specifically evaluating the miRNA profile of patients who respond versus those who do not respond to progestin therapy. Ninety patients attending the Chronic Pelvic Pain Clinic will be recruited, and they will be asked to provide a saliva sample before starting medical therapy. The response to the therapy will be evaluated after 4 months from the beginning of the therapy itself. **Detailed Description:** In recent years, scientific literature has focused on the search for new non-invasive diagnostic tools that can identify patients with endometriosis early and easily, thereby reducing diagnostic delay and enabling the immediate initiation of appropriate treatment. Among these, microRNA (miRNA) is emerging as a promising option. Despite recent progress in this field, a predictive biomarker of response to medical therapy or vice versa, resistance to progesterone in endometriosis, has not yet been identified, including among miRNAs. This study aims, therefore, to identify salivary miRNA signatures specific to endometriosis and differentially expressed between responder and non-responder patients to 2 mg dienogest medical therapy. 90 patients diagnosed with endometriosis attending the Obstetrics and Gynecology Clinic at the Santa Maria della Misericordia Hospital in Udine will be enrolled. The investigators will ask them for a salivary sample before starting the progestin therapy. After 4 months from the beginning, the response will be evaluated. The researchers will evaluate the differences between salivary miRNA of the responders vs non-responders. ### Conditions Module **Conditions:** - Endometriosis **Keywords:** - Endometriosis - miRNA - Progesterone resistance ### Design Module #### Bio Spec **Description:** salivary specimen **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients diagnosed with endometriosis attending the Obstetrics and Gynecology Clinic at the Santa Maria della Misericordia Hospital in Udine, who have not yet started medical therapy. **Intervention Names:** - Drug: Dienogest 2 MG **Label:** Endometriosis patients ### Interventions #### Intervention 1 **Arm Group Labels:** - Endometriosis patients **Description:** The patients will be started on progestin therapy after a saliva sample is collected from them for miRNA analysis. **Name:** Dienogest 2 MG **Other Names:** - zafrilla - devicius - endodien - visanne **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** response to 2 mg dienogest therapy evaluated with NRS (numeric rating scale) scale assessed for acyclic pain, dyspareunia, dyschezia, dysmenorrhea, periovulatory pain **Measure:** response to the progestin therapy **Time Frame:** 0 (pre-therapy) - 4 months (after therapy) **Description:** changes in quality of life assessed with questionnaire SF-36 (Short Form Health Survey 36) **Measure:** changes in quality of life **Time Frame:** 0 (pre-therapy) - 4 months (after therapy) **Description:** Once it is established which patients are responders and which are non-responders, differential salivary miRNAs between the two groups will be identified via sequencing. The miRNA reverse transcription reaction will be performed using the reverse transcription kit TaqMan MicroRNA (Applied Biosystems). The reverse transcription product will be used for Real-time PCR. The small nucleolar RNA RNU6 will be used as an endogenous control. The protocol of Amplification will be carried out using the LightCycler 480 instrument (Roche). For each miRNA, qPCR will be performed in duplicate. The relative expression levels of miRNAs will be calculated using the 2-ΔΔCt method. **Measure:** differences in salivary miRNoma **Time Frame:** sample collection at time 0, analysis after time 4 ### Eligibility Module **Eligibility Criteria:** INCLUSION CRITERIA * Age \> 18 years * Fertile age * Clinical-ultrasound diagnosis or histological diagnosis of endometriosis * Informed consent EXCLUSION CRITERIA * Pregnancy * Pre-menarcheal or post-menopausal status * Chronic pelvic pain syndrome with or without central sensitization assessed with the Central Sensitization Inventory Test (CSI) * Neoplasia, diabetes, BMI \> 30 kg/m2, coagulopathies, autoimmune diseases, or other conditions that may affect salivary miRNA measurement * Currently undergoing progestin therapy **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT **Study Population:** All the patients diagnosed with endometriosis attending the Obstetrics and Gynecology Clinic at the Santa Maria della Misericordia Hospital in Udine, who meet the inclusion criteria. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** matildedegano@rocketmail.com **Name:** Matilde Degano, dr **Phone:** 3206173076 **Phone Ext:** 0039 **Role:** CONTACT **Contact 2:** **Email:** anna.biasioli@asufc.sanita.fvg.it **Name:** Anna Biasioli, dr **Role:** CONTACT #### Locations **Location 1:** **City:** Udine **Contacts:** ***Contact 1:*** - **Email:** matildedegano@rocketmail.com - **Name:** Matilde Degano, dr - **Phone:** 3206173076 - **Phone Ext:** 0039 - **Role:** CONTACT ***Contact 2:*** - **Email:** anna.biasioli@asufc.sanita.fvg.it - **Name:** Anna Biasioli, dr - **Role:** CONTACT ***Contact 3:*** - **Name:** Daniela Cesselli, prof - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Michela Bulfoni, dr - **Role:** SUB_INVESTIGATOR **Country:** Italy **Facility:** University of Udine **State:** UD **Status:** RECRUITING **Zip:** 33100 #### Overall Officials **Official 1:** **Affiliation:** University of Udine **Name:** Giuseppe Vizzielli, prof **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Bendifallah S, Suisse S, Puchar A, Delbos L, Poilblanc M, Descamps P, Golfier F, Jornea L, Bouteiller D, Touboul C, Dabi Y, Darai E. Salivary MicroRNA Signature for Diagnosis of Endometriosis. J Clin Med. 2022 Jan 26;11(3):612. doi: 10.3390/jcm11030612. **PMID:** 35160066 **Citation:** Zhang P, Wang G. Progesterone Resistance in Endometriosis: Current Evidence and Putative Mechanisms. Int J Mol Sci. 2023 Apr 10;24(8):6992. doi: 10.3390/ijms24086992. **PMID:** 37108154 **Citation:** Hon JX, Wahab NA, Karim AKA, Mokhtar NM, Mokhtar MH. MicroRNAs in Endometriosis: Insights into Inflammation and Progesterone Resistance. Int J Mol Sci. 2023 Oct 9;24(19):15001. doi: 10.3390/ijms241915001. **PMID:** 37834449 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000091662 - Term: Genital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7877 - Name: Endometriosis - Relevance: HIGH - As Found: Endometriosis - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004715 - Term: Endometriosis ### Intervention Browse Module - Ancestors - ID: D000003272 - Term: Contraceptive Agents, Male - ID: D000003270 - Term: Contraceptive Agents - ID: D000012102 - Term: Reproductive Control Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000003278 - Term: Contraceptives, Oral, Hormonal - ID: D000003276 - Term: Contraceptives, Oral - ID: D000003271 - Term: Contraceptive Agents, Female - ID: D000080066 - Term: Contraceptive Agents, Hormonal - ID: D000006727 - Term: Hormone Antagonists - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000018931 - Term: Antineoplastic Agents, Hormonal - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M230930 - Name: Dienogest - Relevance: HIGH - As Found: Fidelity - ID: M14244 - Name: Progestins - Relevance: LOW - As Found: Unknown - ID: M14245 - Name: Progesterone - Relevance: LOW - As Found: Unknown - ID: M6494 - Name: Contraceptive Agents - Relevance: LOW - As Found: Unknown - ID: M6496 - Name: Contraceptive Agents, Male - Relevance: LOW - As Found: Unknown - ID: M6500 - Name: Contraceptives, Oral - Relevance: LOW - As Found: Unknown - ID: M6502 - Name: Contraceptives, Oral, Hormonal - Relevance: LOW - As Found: Unknown - ID: M6495 - Name: Contraceptive Agents, Female - Relevance: LOW - As Found: Unknown - ID: M2116 - Name: Contraceptive Agents, Hormonal - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M20966 - Name: Antineoplastic Agents, Hormonal - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000023635 - Term: Dienogest ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414707 **Brief Title:** Efficacy of Vonoprazan in Eradication of Resistant Strain of Helicobacter Pylori **Official Title:** Efficacy of Vonoprazan Versus Proton Pump Inhibitors in Combination With Antibiotics as a Triple Therapy for Eradication of Clarithromycin Resistant Strain of Helicobacter Pylori #### Organization Study ID Info **ID:** FMASU R288/2023 #### Organization **Class:** OTHER **Full Name:** Ain Shams University ### Status Module #### Completion Date **Date:** 2024-04-04 **Type:** ACTUAL #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-04-04 **Type:** ACTUAL #### Start Date **Date:** 2023-10-12 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-04-06 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ain Shams University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** The goal of this Randomized controlled trial is to assessment Efficacy of Vonoprazan versus Proton Pump Inhibitors in Combination with Antibiotics as a triple Therapy for Eradication of Clarithromycin Resistant Strain of Helicobacter Pylori (H. pylori). This randomized controlled study was performed on 2 groups of Egyptian patients diagnosed with dyspepsia; group (1) included 160 patients received Vonoprazan 20 mg oral once daily + Levofloxacin 500 mg oral once daily + Amoxicillin 1 gm oral twice daily for 14 days and group (2) included 160 patients received Pantoprazole 40 mg oral twice daily + Levofloxacin 500 mg oral once daily + Amoxicillin 1 gm oral twice daily for 14 days. All patients of the two groups were followed up for persistence of infection 8 weeks after the end of treatment by testing fecal H. pylori antigen (Ag). **Detailed Description:** This randomized controlled trial included two groups of Egyptian patients diagnosed with dyspepsia related to Clarithromycin-resistant strains of H.pylori. * Group (1) included 160 patients received Vonoprazan 20 mg oral once daily + Levofloxacin 500 mg oral once daily + Amoxicillin 1 gm oral twice daily for two weeks. * Group (2) included 160 patients received Pantoprazole 40 mg oral twice daily + Levofloxacin 500 mg oral once daily + Amoxicillin 1 gm oral twice daily for 14 days. The included cases were collected from gastroenterology outpatient clinic and inpatient department at Ain shams University hospital between October 2023 and April 2024. The work had been conducted after the scientific ethics committee approval and after obtaining an informed consent from all the included cases. All cases were diagnosed with H. Pylori resistant infection after clarithromycin based treatment regimen for H. pylori confirmed with persistent positive test of fecal H. pylori Ag before the starting of the study. All patients of the two groups were followed up for persistence of infection 8-weeks following the end of therapy by testing fecal H. pylori Ag. And the study end-points were compliance failure or gastrointestinal bleeding. Each participant had been exposed to comprehensive taking of history, full physical assessment, full laboratory examination including (CBC, liver profile (ALT, AST), kidney functions test (S. creat), fecal H. pylori Ag testing before the starting of the trial and another stool sample were taken after termination of treatment by 8 weeks for evaluating of the eradication of H. pylori infection and pelvi-abdominal U/S was done for all patients. ### Conditions Module **Conditions:** - Helicobacter Pylori Infection ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This randomized controlled trial included two groups of Egyptian patients diagnosed with dyspepsia related to Clarithromycin-resistant strains of H.pylori. * Group (1) ( Vonoprazan Group) included 160 patients received Vonoprazan 20 mg oral once daily + Levofloxacin 500 mg oral once daily + Amoxicillin 1 gm oral twice daily for two weeks. * Group (2)(Pantoprazole Group) included 160 patients received Pantoprazole 40 mg oral twice daily + Levofloxacin 500 mg oral once daily + Amoxicillin 1 gm oral twice daily for 14 days. All cases were diagnosed with H. Pylori resistant infection after clarithromycin based treatment regimen for H. pylori confirmed with persistent positive test of fecal H. pylori Ag before the starting of the study. All patients of the two groups were followed up for persistence of infection 8-weeks following the end of therapy by testing fecal H. pylori Ag. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 320 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** included 160 patients received Vonoprazan 20 mg oral once daily + Levofloxacin 500 mg oral once daily + Amoxicillin 1 gm oral twice daily for two weeks. **Intervention Names:** - Drug: Vonoprazan, Amoxicillin and Levofloxacin **Label:** Vonoprazan Group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** included 160 patients received Pantoprazole 40 mg oral twice daily + Levofloxacin 500 mg oral once daily + Amoxicillin 1 gm oral twice daily for 14 days **Intervention Names:** - Drug: Pantoprazole 40mg, Amoxicillin and Levofloxacin **Label:** Pantoprazole Group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Vonoprazan Group **Description:** Group (1) included 160 patients received Vonoprazan 20 mg oral once daily + Levofloxacin 500 mg oral once daily + Amoxicillin 1 gm oral twice daily for 14 days. **Name:** Vonoprazan, Amoxicillin and Levofloxacin **Other Names:** - Vonaspire 20 mg - Amoxil 1 gm - Tavanic 500 mg **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Pantoprazole Group **Description:** Group (2) included 160 patients received Pantoprazole 40 mg oral twice daily + Levofloxacin 500 mg oral once daily + Amoxicillin 1 gm oral twice daily for 14 days. **Name:** Pantoprazole 40mg, Amoxicillin and Levofloxacin **Other Names:** - controloc 40 mg - Amoxil 1 gm - Tavanic 500 mg **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** comparison between the efficiency of Vonoprazan and Pantoprazole in eradication of Clarithromycin-resistant strain of H.Pylori. **Measure:** Assessment the fecal H.Pylori Ag after receiving Vonoprazan in combination with antibiotics as a triple therapy in patients with Clarithromycin-resistant strain of H.Pylori infection. **Time Frame:** All patients of the two groups were followed up for 2 months. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients with dyspepsia related to Clarithromycin-resistant strains of H.pylori. All cases were diagnosed with H. Pylori resistant infection after clarithromycin based treatment regimen for H. pylori confirmed with persistent positive test of fecal H. pylori Ag before the starting of the study. * Must be able to swallow tablets. Exclusion Criteria: * Cases with drug allergy from drugs included in the study. * those having inflammatory-bowel diseases. * those with malabsorption syndrome. * those having gastroenterology malignancy. * patients on immunotherapy. * HIV patients. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Mostafa Elfors **Zip:** 3753450 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000000892 - Term: Anti-Infective Agents, Urinary - ID: D000059005 - Term: Topoisomerase II Inhibitors - ID: D000059003 - Term: Topoisomerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents - ID: D000065609 - Term: Cytochrome P-450 CYP1A2 Inhibitors - ID: D000065607 - Term: Cytochrome P-450 Enzyme Inhibitors - ID: D000000897 - Term: Anti-Ulcer Agents - ID: D000005765 - Term: Gastrointestinal Agents - ID: D000054328 - Term: Proton Pump Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M3995 - Name: Amoxicillin - Relevance: HIGH - As Found: Colorectal - ID: M30370 - Name: Levofloxacin - Relevance: HIGH - As Found: Sodium chloride - ID: M17946 - Name: Ofloxacin - Relevance: HIGH - As Found: Sodium chloride - ID: M1783 - Name: Pantoprazole - Relevance: HIGH - As Found: Average - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M19585 - Name: Clarithromycin - Relevance: LOW - As Found: Unknown - ID: M27630 - Name: Proton Pump Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M30537 - Name: Cytochrome P-450 Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4188 - Name: Antacids - Relevance: LOW - As Found: Unknown - ID: M4219 - Name: Anti-Ulcer Agents - Relevance: LOW - As Found: Unknown - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000658 - Term: Amoxicillin - ID: D000064704 - Term: Levofloxacin - ID: D000015242 - Term: Ofloxacin - ID: D000077402 - Term: Pantoprazole ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414694 **Brief Title:** Inpatient Penicillin Delabeling for Low-Risk Patients **Official Title:** Inpatient Penicillin Delabeling for Low-Risk Patients #### Organization Study ID Info **ID:** 23-09373-FB #### Organization **Class:** OTHER **Full Name:** University of Tennessee ### Status Module #### Completion Date **Date:** 2025-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2023-09-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-04-25 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Tennessee #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study seeks to enroll patients admitted to a children's hospital with identified penicillin allergy. A screening checklist is performed to identify patients with very low or low risk histories of penicillin allergy to offer direct oral challenges to the antibiotic class to de-label patient's with drug allergies. **Detailed Description:** This is a pilot study looking to utilize a novel criterion to identify low risk penicillin allergies for patients admitted to a children's hospital to evaluate safety and efficacy of direct oral challenges to patients with very low or low risk histories as identified in novel criterion. ### Conditions Module **Conditions:** - Penicillin - Drug Allergy ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 25 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients who met enrollment criteria proceed to direct oral challenge with penicillin with one hour observation, 48 hour phone call, six month follow-up. **Intervention Names:** - Procedure: Direct Oral Challenge **Label:** Direct Challenge **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Direct Challenge **Description:** Direct oral challenge to penicillin at a goal dose of 45 mg/kg given in a 10%/90% dose **Name:** Direct Oral Challenge **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Pass or Failure of direct oral challenge **Measure:** Direct Oral Challenge **Time Frame:** 2 hours #### Secondary Outcomes **Description:** Follow-up phone call to assess adverse reaction by 48 hours. Data to be collected by screening questionnaire to assess for reactions such as fever, rash, manufacturer labeled adverse side effects. **Measure:** Follow-up at 48 **Time Frame:** 48 hours **Description:** Follow-up phone call to assess subsequent tolerance or reaction of penicillin based antibiotic if prescribed in this time period. Data to be collected by screening questionnaire. **Measure:** Follow-up at 6 months **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients \>2 years * Patients identified via EMR as having a penicillin, amoxicillin, amoxicillin/clavulanic acid allergy Exclusion Criteria: * Female patients aged \>8 years of age * Patients with hemodynamic instability * Patients identified with moderate or high risk histories per protocol * Patients currently taking oral antihistamines in 48 hours prior to direct challenge * Patients currently taking oral steroids in 48 hours prior to direct challenge * Patients currently receiving medications for nausea, shortness of breath, **Maximum Age:** 30 Years **Minimum Age:** 2 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Memphis **Country:** United States **Facility:** University of Tennessee Health Science Center **State:** Tennessee **Zip:** 38163 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000064420 - Term: Drug-Related Side Effects and Adverse Reactions - ID: D000064419 - Term: Chemically-Induced Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC25 - Name: Substance Related Disorders ### Condition Browse Module - Browse Leaves - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M7517 - Name: Drug Hypersensitivity - Relevance: HIGH - As Found: Drug Allergy - ID: M30303 - Name: Drug-Related Side Effects and Adverse Reactions - Relevance: LOW - As Found: Unknown - ID: M30302 - Name: Chemically-Induced Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004342 - Term: Drug Hypersensitivity ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M13317 - Name: Penicillins - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414681 **Brief Title:** Combination of Tagraxofusp With Pacritinib in Patients With Intermediate-1 or Higher Myelofibrosis, Who Have Had Prior Therapy With the Approved JAK Inhibitors or in Which Therapy With the Approved JAK Inhibitors is Not Appropriate, Contraindicated or Declined **Official Title:** An Open Label Pilot Trial of the Combination of Tagraxofusp With Pacritinib in Patients With Intermediate-1 or Higher Myelofibrosis, Who Have Had Prior Therapy With the Approved JAK Inhibitors or in Which Therapy With the Approved JAK Inhibitors is Not Appropriate, Contraindicated or Declined #### Organization Study ID Info **ID:** STUDY00160238 #### Organization **Class:** OTHER **Full Name:** University of Kansas Medical Center ### Status Module #### Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-02-23 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Kansas Medical Center #### Responsible Party **Investigator Affiliation:** University of Kansas Medical Center **Investigator Full Name:** Abdulraheem Yacoub **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this open-label, single-center, pilot trial is to test the combination of Tagraxofusp (TAG) with Pacritinib (PAC) in patients with intermediate-II or higher myelofibrosis (MF), who have had prior therapy with the approved JAK1/2 inhibitor or in which therapy with the approved JAK1/2 inhibitors is not appropriate, contraindicated or declined by the subjects. The Primary Objective is to: 1. Characterized efficacy of the combination of Tagraxofusp and Pacritinib. The Secondary Objective is to: 1. characterize the safety profile of the combination Tagraxofusp and Pacritinib. 2, Characterize the feasibility of the combination Tagraxofusp and Pacritinib. 3. Characterize hematologic improvement with the combination Tagraxofusp and Pacritinib. 4. Evaluate and compare the effect of Tagraxofusp and Pacritinib on participant reports of MF symptoms. Exploratory: Pharmacokinetic (PK) testing of Tagraxofusp and Pacritinib to assess clinical predictors of response. Next Generation Sequencing (NGS) Testing to define the number and the allele burden of pathological mutations, as well as the changes over the course of therapy, both in regard to progression and response. Blood will be collected and stored at KU BRCF for future study related PK analysis **Detailed Description:** A combination of these agent provides rational scientific merit and compatible mechanisms of action by targeting myelofibrosis stem cells and BM environment, in combination with effective JAK2 and IRAK1 inhibition resulting in improvement in MPN related symptoms and splenomegaly without overlapping toxicities. Both agents have been studied in mildly depleted bone marrow phenotypes showing safety and hematological improvements ### Conditions Module **Conditions:** - Myelofibrosis，MF **Keywords:** - Myelofibrosis - MF - JAK 1/2 - Tagraxofusp - TAG - Pacritinib - PAC - Tagraxofusp with Pacritinib - Intermediate II Myelofibrosis - Higher Myelofibrosis ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Tagraxofusp Patients will receive 12 micrograms/kg of Tagraxofusp (TAG) by IV infusion once daily for 3 consecutive days. Pacritinib Pacritinib (PAC) will be given orally, 200 mg twice per day starting at C2D4 and administered continuously (Subsequent cycles start on Day 1 of the Cycle). **Intervention Names:** - Drug: Tagraxofusp - Drug: Pacritinib **Label:** Tagrxofusp (IV) in combination with Pacritinib (Oral) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Tagrxofusp (IV) in combination with Pacritinib (Oral) **Description:** Tagraxofusp Patients will receive 12 micrograms/kg of Tagraxofusp (TAG) by IV infusion once daily for 3 consecutive days. **Name:** Tagraxofusp **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Tagrxofusp (IV) in combination with Pacritinib (Oral) **Description:** Pacritinib Pacritinib (PAC) will be given orally, 200 mg twice per day starting at C2D4 and administered continuously (Subsequent cycles start on Day 1 of the Cycle). **Name:** Pacritinib **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** MRI of abdomen will be performed WITHOUT contrast. If MRI is contraindicated - CT scan will be allowed (IV contrast will be used unless contraindicated). The same type of Imaging used at screening must continue to be used throughout the study. **Measure:** Spleen volume reduction by MRI or CT imaging, achieving ≥ 35% reduction in spleen volume imaging from baseline to week 24. **Time Frame:** Baseline to up to 24 weeks **Description:** Improvement in symptoms: \>/= 50% reduction in Modified Total Symptom Score (mTSS) from baseline to week 24 as measured by the Myeloproliferative Neoplasms Symptom Assessment Form Total Symptom Score Version 2.0 (MPN-SAF TSS 2.0). The MPN Symptom Assessment Form) includes the assessment of symptoms that are relevant to myelofibrosis. MPN-SAF was simplified to a concise and abbreviated tool called the MPN-SAF Total Symptom Score (MPN-SAF TSS), that is used for the assessment of the 10 most relevant symptoms in subjects with MPN (fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fever) in both clinical practice and clinical trial settings. The symptom severity is rated by subjects on a scale of 1 to10 MPN-SAF-TSS: a total score will be calculated by the addition of every individual symptom score. The change from baseline will be statically measured and reported. **Measure:** Change from baseline in the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score Version 2.0 (MPN-SAF TSS 2.0) to week 24. **Time Frame:** Baseline to up to 24 weeks #### Secondary Outcomes **Description:** Number of participants with treatment related adverse events a assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0. **Measure:** Number of participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 from baseline to End of Safety Follow-up (30 days after end of treatment). **Time Frame:** Baseline to End of Safety follow up to End of Treatment (up to 1 year) **Description:** From Baseline to best response within 1 year **Measure:** Change from baseline in Anemia (hemoglobin GM/DL, iron ug/DL, and hematocrit %) improvement within or at 1 year **Time Frame:** Baseline, Week 24 and End of Treatment (up to 1 year) **Measure:** Patient's Global Impression (perception) of Change **Time Frame:** Every cycle (each cycle is 28 days) day 1 starting at Cycle 2 to End of Treatment (up to 1 year) **Description:** Based on the proportion of patients who report "much improved" or "very much improved" symptoms at Week 24 based on the Patient Impression of Global Change (PGIC). A PGIC score of 2 for "much improved" or a score of 1 for "very much improved." The PGIC uses a score between 1 and 7 (1 being "very much improved" to 7 being "very much worse)." **Measure:** Improvement in Quality of Life based on Patient Impression of Global Change (PGIC). A PGIC score of 2 for "much improved" or a score of 1 for "very much improved." **Time Frame:** Baseline to up to 24 weeks **Description:** From Baseline to best response within 1 year **Measure:** Change from baseline in platelet count in K/UL within 1 year **Time Frame:** Baseline, up to 24 weeks and End of Treatment (up to 1 year) **Description:** From Baseline to best response within 1 year **Measure:** Change from baseline in Anemia (iron ug/DL) **Time Frame:** Baseline, Week 24 and End of Treatment (up to 1 year) **Description:** From Baseline to best response within 1 year **Measure:** Change from baseline in Anemia (hematocrit %) **Time Frame:** Baseline, Week 24 and End of Treatment (up to 1 year) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent. 2. The participant or LAR has signed informed consent prior to initiation of any study-specific procedures or treatment. 3. The patient is able to adhere to the study visit schedule and other protocol requirements. 4. Males and females age ≥ 18 years. 5. ECOG Performance Status 0 - 2 (Appendix A). 6. Life expectancy of \> 6 months. 7. Patient meets the 2016 WHO diagnostic criteria for MF and has an IPSS/DIPSS/DIPSS-plus intermediate-II or higher-risk disease. 8. Patients who have indications for therapy per investigator or patient's choice, such as Splenomegaly, \>5 CM BCM or mTSS ≥ 8 or mTSS Itching, night sweats, or bone pain ≥ 5 or Significant cytopenias including Hgb \<10 g/dl, Platelet count less than 75 k/UL 9. Patients treated with a JAK inhibitor for \>3 months and: had inadequate response to treatment, i.e., \< 10% reduction of spleen by imaging, or less than 25% reduction by spleen length on physical exam or lack of control of MF symptoms that is not satisfactory to the patient. NOTE: Participants who had contraindication to therapy with the approved JAK inhibitor including subject's refusal of therapy are eligible. 10. A least 4 weeks have elapsed between the last dose of any MF-directed drug treatments, including hydroxyurea (HU), Interferon or glucocorticosteroids. NOTE: If patient is on a stable dose of glucocorticosteroids for another indication, they will be allowed into this study, AND patients on a stable dose of erythropoiesis-stimulating agents (ESA) are allowed on the study. 11. Patient is not eligible for an immediate allo-SCT. 12. Adequate baseline organ, cardiac, and renal function as defined by: LVEF ≥ 50% by ECHO within 6 months of study treatment initiation No clinically significant abnormalities on a 12-lead ECG, and no QTcF ≥ 480 msec Serum creatinine ≤ 1.5 mg/dL Serum albumin ≥ 3.2 g/dL (Note: albumin infusions are not permitted to enable eligibility) INR and PTT ≤ 1.5x ULN Albumin Supplementation Prior to the first dose, participant must have serum albumin ≥ to 3.2 g/dL. Note- for any participants with serum albumin ≤ to 4.0 g/dL, it will be advisable but up to physician's discretion to administer 25g increments of albumin infusion before the first dose. Total bilirubin ≤ 4x ULN AST and ALT ≤ 5 x ULN ANC ≥ 0.5 x 109/L PT or INR and PTT \< = 1.5 x ULN 13. If the patient is a woman of child-bearing potential (WOCBP), they should have a negative serum pregnancy test no more than 7 days prior to start of treatment. (Note: WOCBP include any female who has experienced menarche and who has not undergone successful sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea ≥ 12 consecutive months; or women on hormone replacement therapy with documented serum follicle stimulating hormone level ≥ 35 mIU/mL). 14. Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed in Child-Bearing Potential/Pregnancy section for the duration of study participation and for 3 months following completion of therapy. Exclusion Criteria: 1. Simultaneously enrolled in any therapeutic clinical trial 2. Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study. 3. The patient has received treatment with chemotherapy, wide-field radiation, or biologic therapy within 14 days of study entry. 4. The patient has received treatment with another investigational agent within 14 days of study entry. 5. Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements. 6. Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation. 7. Any condition or other contraindication to therapy as deemed by the principal investigator to place the subject at an unacceptably high risk for toxicities. 8. Is pregnant or breastfeeding. 9. Has a known allergic reaction to any excipient contained in the study drug formulation. 10. Active Grade 3 (per the NCI CTCAE, Version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment. 11. Prior therapy with Tagraxofusp or Pacritinib. 12. Presence of peripheral blood or bone marrow blast count \> 10% 13. Active Graft versus Host Disease (GVHD) 14. For patients who have previously had Stem Cell Therapy (SCT) - The patient is receiving immunosuppressive therapy. EXCEPTION: low-dose prednisone (≤10 mg/day) - for treatment or prophylaxis of graft-versus-host disease (GVHD). If the patient has been on immunosuppressive treatment or prophylaxis for GVHD, the treatment(s) must have been discontinued at least 14 days prior to study treatment and there must be no evidence of Grade ≥ 2 GVHD. 15. Other uncontrolled active malignancy as determined by the principal investigator 16. The patient has an active malignancy and/or cancer history that may confound the assessment of the study endpoints. Patients with a past cancer history (within 2 years of entry) with substantial potential for recurrence and/or ongoing active malignancy must be discussed with the Sponsor before study entry. Patients with the following neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ, cervical intraepithelial neoplasia, organ-confined prostate cancer with no evidence of progressive disease. 17. The patient has clinically significant cardiovascular disease (e.g. uncontrolled or any New York Heart Association Class 2 or greater congestive heart failure, uncontrolled angina, history of myocardial infarction, unstable angina or stroke within 6 months prior to study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication). 18. Any gastrointestinal or metabolic condition that could interfere with absorption of oral medication. 19. Prior therapy with Pacritinib (PAC) or Tagraxofusp (TAG). 20. The patient has persistent clinically significant toxicities Grade ≥ 2 from previous therapies, including cytotoxic chemotherapy, targeted therapies, biological therapies, or immunotherapies, not readily controlled by supportive measures (excluding alopecia, nausea, and fatigue). 21. The patient has uncontrolled, clinically significant pulmonary disease (e.g. chronic obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the Investigator would put the patient at significant risk for pulmonary complications during the study. 22. The patient has known active or suspected central nervous system (CNS) disease. If suspected, CNS disease should be ruled out with relevant imaging and/or examination of cerebrospinal fluid. 23. Current systemic treatment with strong or moderate CYP3A4 inhibitor or P450 inducer. EXCEPTION: Patients who discontinue this treatment by Day 14 before start of treatment (Day -14) or 5 half-lives, whichever is shorter. 24. Use of full-dose anticoagulation and use of anti-platelet therapy other than aspirin 81mg daily within 14 days prior to D1. 25. Recent unprovoked bleeding of grade ≥ 2 within the last 3 months prior to Day 1. 26. Active uncontrolled diarrhea or inflammatory bowel disease (IBD) 27. Known sero-positivity for Hepatitis A (HAV), Hepatitis B (HBV), Hepatitis C (HCV), Human Immunodeficiency Virus (HIV) 28. Patients with history of clinically significant bleeding or on anticoagulants 29. Patients with moderate (Child-Pugh B ) and severe (Child -Pugh C) hepatic impairment will not be enrolled in the study. 30. Patients with eGFR \< 30 mL/min will not be enrolled **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** kucc_navigation@kumc.edu **Name:** KUCC Navigation **Phone:** 913-588-3671 **Role:** CONTACT **Contact 2:** **Email:** jward3@kumc.edu **Name:** Jan Ward **Phone:** 913-588-1809 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** The University of Kansas Medical Center **Name:** Abdulraheem Yacoub, Doctor of Medicine **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Mesa RA, Gotlib J, Gupta V, Catalano JV, Deininger MW, Shields AL, Miller CB, Silver RT, Talpaz M, Winton EF, Harvey JH, Hare T, Erickson-Viitanen S, Sun W, Sandor V, Levy RS, Kantarjian HM, Verstovsek S. Effect of ruxolitinib therapy on myelofibrosis-related symptoms and other patient-reported outcomes in COMFORT-I: a randomized, double-blind, placebo-controlled trial. J Clin Oncol. 2013 Apr 1;31(10):1285-92. doi: 10.1200/JCO.2012.44.4489. Epub 2013 Feb 19. **PMID:** 23423753 **Citation:** Jordan CT, Guzman ML, Noble M. Cancer stem cells. N Engl J Med. 2006 Sep 21;355(12):1253-61. doi: 10.1056/NEJMra061808. No abstract available. **PMID:** 16990388 **Citation:** Hurst H, Bolton J. Assessing the clinical significance of change scores recorded on subjective outcome measures. J Manipulative Physiol Ther. 2004 Jan;27(1):26-35. doi: 10.1016/j.jmpt.2003.11.003. **PMID:** 14739871 **Citation:** Tefferi A. Challenges facing JAK inhibitor therapy for myeloproliferative neoplasms. N Engl J Med. 2012 Mar 1;366(9):844-6. doi: 10.1056/NEJMe1115119. No abstract available. **PMID:** 22375977 **Citation:** Tefferi A. Primary myelofibrosis: 2013 update on diagnosis, risk-stratification, and management. Am J Hematol. 2013 Feb;88(2):141-50. doi: 10.1002/ajh.23384. Erratum In: Am J Hematol. 2013 May;88(5):437-45. **PMID:** 23349007 **Citation:** Barosi G, Tefferi A, Besses C, Birgegard G, Cervantes F, Finazzi G, Gisslinger H, Griesshammer M, Harrison C, Hehlmann R, Hermouet S, Kiladjian JJ, Kroger N, Mesa R, Mc Mullin MF, Pardanani A, Passamonti F, Samuelsson J, Vannucchi AM, Reiter A, Silver RT, Verstovsek S, Tognoni G, Barbui T. Clinical end points for drug treatment trials in BCR-ABL1-negative classic myeloproliferative neoplasms: consensus statements from European LeukemiaNET (ELN) and Internation Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT). Leukemia. 2015 Jan;29(1):20-6. doi: 10.1038/leu.2014.250. Epub 2014 Aug 25. **PMID:** 25151955 **Citation:** Harrison C, Kiladjian JJ, Al-Ali HK, Gisslinger H, Waltzman R, Stalbovskaya V, McQuitty M, Hunter DS, Levy R, Knoops L, Cervantes F, Vannucchi AM, Barbui T, Barosi G. JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis. N Engl J Med. 2012 Mar 1;366(9):787-98. doi: 10.1056/NEJMoa1110556. **PMID:** 22375970 **Citation:** Harrison CN, Mesa RA, Kiladjian JJ, Al-Ali HK, Gisslinger H, Knoops L, Squier M, Sirulnik A, Mendelson E, Zhou X, Copley-Merriman C, Hunter DS, Levy RS, Cervantes F, Passamonti F, Barbui T, Barosi G, Vannucchi AM. Health-related quality of life and symptoms in patients with myelofibrosis treated with ruxolitinib versus best available therapy. Br J Haematol. 2013 Jul;162(2):229-39. doi: 10.1111/bjh.12375. Epub 2013 May 14. **PMID:** 23672349 **Citation:** Verstovsek S, Mesa RA, Gotlib J, Levy RS, Gupta V, DiPersio JF, Catalano JV, Deininger M, Miller C, Silver RT, Talpaz M, Winton EF, Harvey JH Jr, Arcasoy MO, Hexner E, Lyons RM, Paquette R, Raza A, Vaddi K, Erickson-Viitanen S, Koumenis IL, Sun W, Sandor V, Kantarjian HM. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med. 2012 Mar 1;366(9):799-807. doi: 10.1056/NEJMoa1110557. **PMID:** 22375971 **Citation:** Mughal TI, Cross NC, Padron E, Tiu RV, Savona M, Malcovati L, Tibes R, Komrokji RS, Kiladjian JJ, Garcia-Manero G, Orazi A, Mesa R, Maciejewski JP, Fenaux P, Itzykson R, Mufti G, Solary E, List AF. An International MDS/MPN Working Group's perspective and recommendations on molecular pathogenesis, diagnosis and clinical characterization of myelodysplastic/myeloproliferative neoplasms. Haematologica. 2015 Sep;100(9):1117-30. doi: 10.3324/haematol.2014.114660. **PMID:** 26341525 **Citation:** Barbui T, Tefferi A, Vannucchi AM, Passamonti F, Silver RT, Hoffman R, Verstovsek S, Mesa R, Kiladjian JJ, Hehlmann R, Reiter A, Cervantes F, Harrison C, Mc Mullin MF, Hasselbalch HC, Koschmieder S, Marchetti M, Bacigalupo A, Finazzi G, Kroeger N, Griesshammer M, Birgegard G, Barosi G. Philadelphia chromosome-negative classical myeloproliferative neoplasms: revised management recommendations from European LeukemiaNet. Leukemia. 2018 May;32(5):1057-1069. doi: 10.1038/s41375-018-0077-1. Epub 2018 Feb 27. **PMID:** 29515238 **Citation:** Prager BC, Xie Q, Bao S, Rich JN. Cancer Stem Cells: The Architects of the Tumor Ecosystem. Cell Stem Cell. 2019 Jan 3;24(1):41-53. doi: 10.1016/j.stem.2018.12.009. **PMID:** 30609398 **Citation:** Desai A, Yan Y, Gerson SL. Concise Reviews: Cancer Stem Cell Targeted Therapies: Toward Clinical Success. Stem Cells Transl Med. 2019 Jan;8(1):75-81. doi: 10.1002/sctm.18-0123. Epub 2018 Oct 17. **PMID:** 30328686 **Citation:** Yan B, Chen Q, Shimada K, Tang M, Li H, Gurumurthy A, Khoury JD, Xu B, Huang S, Qiu Y. Histone deacetylase inhibitor targets CD123/CD47-positive cells and reverse chemoresistance phenotype in acute myeloid leukemia. Leukemia. 2019 Apr;33(4):931-944. doi: 10.1038/s41375-018-0279-6. Epub 2018 Oct 5. **PMID:** 30291336 **Citation:** Arai N, Homma M, Abe M, Baba Y, Murai S, Watanuki M, Kawaguchi Y, Fujiwara S, Kabasawa N, Tsukamoto H, Uto Y, Ariizumi H, Yanagisawa K, Hattori N, Saito B, Shiozawa E, Harada H, Yamochi-Onizuka T, Nakamaki T, Takimoto M. Impact of CD123 expression, analyzed by immunohistochemistry, on clinical outcomes in patients with acute myeloid leukemia. Int J Hematol. 2019 May;109(5):539-544. doi: 10.1007/s12185-019-02616-y. Epub 2019 Mar 7. **PMID:** 30847774 **Citation:** Stevens BM, Zhang W, Pollyea DA, Winters A, Gutman J, Smith C, Budde E, Forman SJ, Jordan CT, Purev E. CD123 CAR T cells for the treatment of myelodysplastic syndrome. Exp Hematol. 2019 Jun;74:52-63.e3. doi: 10.1016/j.exphem.2019.05.002. Epub 2019 May 25. **PMID:** 31136781 **Citation:** Jordan CT, Upchurch D, Szilvassy SJ, Guzman ML, Howard DS, Pettigrew AL, Meyerrose T, Rossi R, Grimes B, Rizzieri DA, Luger SM, Phillips GL. The interleukin-3 receptor alpha chain is a unique marker for human acute myelogenous leukemia stem cells. Leukemia. 2000 Oct;14(10):1777-84. doi: 10.1038/sj.leu.2401903. **PMID:** 11021753 **Citation:** Tehranchi R, Woll PS, Anderson K, Buza-Vidas N, Mizukami T, Mead AJ, Astrand-Grundstrom I, Strombeck B, Horvat A, Ferry H, Dhanda RS, Hast R, Ryden T, Vyas P, Gohring G, Schlegelberger B, Johansson B, Hellstrom-Lindberg E, List A, Nilsson L, Jacobsen SE. Persistent malignant stem cells in del(5q) myelodysplasia in remission. N Engl J Med. 2010 Sep 9;363(11):1025-37. doi: 10.1056/NEJMoa0912228. **PMID:** 20825315 **Citation:** Aldinucci D, Olivo K, Lorenzon D, Poletto D, Gloghini A, Carbone A, Pinto A. The role of interleukin-3 in classical Hodgkin's disease. Leuk Lymphoma. 2005 Mar;46(3):303-11. doi: 10.1080/10428190400013712. **PMID:** 15621820 **Citation:** Munoz L, Nomdedeu JF, Lopez O, Carnicer MJ, Bellido M, Aventin A, Brunet S, Sierra J. Interleukin-3 receptor alpha chain (CD123) is widely expressed in hematologic malignancies. Haematologica. 2001 Dec;86(12):1261-9. **PMID:** 11726317 **Citation:** Aldinucci D, Poletto D, Gloghini A, Nanni P, Degan M, Perin T, Ceolin P, Rossi FM, Gattei V, Carbone A, Pinto A. Expression of functional interleukin-3 receptors on Hodgkin and Reed-Sternberg cells. Am J Pathol. 2002 Feb;160(2):585-96. doi: 10.1016/S0002-9440(10)64878-X. **PMID:** 11839579 **Citation:** Black JH, McCubrey JA, Willingham MC, Ramage J, Hogge DE, Frankel AE. Diphtheria toxin-interleukin-3 fusion protein (DT(388)IL3) prolongs disease-free survival of leukemic immunocompromised mice. Leukemia. 2003 Jan;17(1):155-9. doi: 10.1038/sj.leu.2402744. **PMID:** 12529673 **Citation:** Frolova O, Frankel AE, Korchin B, et al. IL3R-Directed Agents, SL-401 and SL-501, Inhibit the Growth of Leukemia Stem cells in CML. Blood (ASH Meeting Abstracts) 2010 116: Abstract 3403 **Citation:** Florian S, Sonneck K, Hauswirth AW, Krauth MT, Schernthaner GH, Sperr WR, Valent P. Detection of molecular targets on the surface of CD34+/CD38-- stem cells in various myeloid malignancies. Leuk Lymphoma. 2006 Feb;47(2):207-22. doi: 10.1080/10428190500272507. **PMID:** 16321850 **Citation:** Lhermitte L, de Labarthe A, Dupret C, Lapillonne H, Millien C, Landman-Parker J, Hermine O, Baruchel A, Sigaux F, Macintyre E, Asnafi V. Most immature T-ALLs express Ra-IL3 (CD123): possible target for DT-IL3 therapy. Leukemia. 2006 Oct;20(10):1908-10. doi: 10.1038/sj.leu.2404349. Epub 2006 Aug 10. No abstract available. **PMID:** 16900212 **Citation:** Vergez F, Green AS, Tamburini J, Sarry JE, Gaillard B, Cornillet-Lefebvre P, Pannetier M, Neyret A, Chapuis N, Ifrah N, Dreyfus F, Manenti S, Demur C, Delabesse E, Lacombe C, Mayeux P, Bouscary D, Recher C, Bardet V. High levels of CD34+CD38low/-CD123+ blasts are predictive of an adverse outcome in acute myeloid leukemia: a Groupe Ouest-Est des Leucemies Aigues et Maladies du Sang (GOELAMS) study. Haematologica. 2011 Dec;96(12):1792-8. doi: 10.3324/haematol.2011.047894. Epub 2011 Sep 20. **PMID:** 21933861 **Citation:** van Rhenen A, Feller N, Kelder A, Westra AH, Rombouts E, Zweegman S, van der Pol MA, Waisfisz Q, Ossenkoppele GJ, Schuurhuis GJ. High stem cell frequency in acute myeloid leukemia at diagnosis predicts high minimal residual disease and poor survival. Clin Cancer Res. 2005 Sep 15;11(18):6520-7. doi: 10.1158/1078-0432.CCR-05-0468. **PMID:** 16166428 **Citation:** Lucas N, Duchmann M, Rameau P, Noel F, Michea P, Saada V, Kosmider O, Pierron G, Fernandez-Zapico ME, Howard MT, King RL, Niyongere S, Diop MK, Fenaux P, Itzykson R, Willekens C, Ribrag V, Fontenay M, Padron E, Soumelis V, Droin N, Patnaik MM, Solary E. Biology and prognostic impact of clonal plasmacytoid dendritic cells in chronic myelomonocytic leukemia. Leukemia. 2019 Oct;33(10):2466-2480. doi: 10.1038/s41375-019-0447-3. Epub 2019 Mar 20. **PMID:** 30894665 **Citation:** Rapoport AP, Luhowskyj S, Doshi P, DiPersio JF. Mutational analysis of the alpha subunit of the human interleukin-3 receptor. Blood. 1996 Jan 1;87(1):112-22. **PMID:** 8547632 **Citation:** Ratts R, Trujillo C, Bharti A, vanderSpek J, Harrison R, Murphy JR. A conserved motif in transmembrane helix 1 of diphtheria toxin mediates catalytic domain delivery to the cytosol. Proc Natl Acad Sci U S A. 2005 Oct 25;102(43):15635-40. doi: 10.1073/pnas.0504937102. Epub 2005 Oct 17. **PMID:** 16230620 **Citation:** Kochi SK, Collier RJ. DNA fragmentation and cytolysis in U937 cells treated with diphtheria toxin or other inhibitors of protein synthesis. Exp Cell Res. 1993 Sep;208(1):296-302. doi: 10.1006/excr.1993.1249. **PMID:** 8359223 **Citation:** Pemmaraju N, Lane AA, Sweet KL, Stein AS, Vasu S, Blum W, Rizzieri DA, Wang ES, Duvic M, Sloan JM, Spence S, Shemesh S, Brooks CL, Balser J, Bergstein I, Lancet JE, Kantarjian HM, Konopleva M. Tagraxofusp in Blastic Plasmacytoid Dendritic-Cell Neoplasm. N Engl J Med. 2019 Apr 25;380(17):1628-1637. doi: 10.1056/NEJMoa1815105. **PMID:** 31018069 **Citation:** Mesa RA, Vannucchi AM, Mead A, Egyed M, Szoke A, Suvorov A, Jakucs J, Perkins A, Prasad R, Mayer J, Demeter J, Ganly P, Singer JW, Zhou H, Dean JP, Te Boekhorst PA, Nangalia J, Kiladjian JJ, Harrison CN. Pacritinib versus best available therapy for the treatment of myelofibrosis irrespective of baseline cytopenias (PERSIST-1): an international, randomised, phase 3 trial. Lancet Haematol. 2017 May;4(5):e225-e236. doi: 10.1016/S2352-3026(17)30027-3. Epub 2017 Mar 20. **PMID:** 28336242 **Citation:** Mascarenhas J, Hoffman R, Talpaz M, Gerds AT, Stein B, Gupta V, Szoke A, Drummond M, Pristupa A, Granston T, Daly R, Al-Fayoumi S, Callahan JA, Singer JW, Gotlib J, Jamieson C, Harrison C, Mesa R, Verstovsek S. Pacritinib vs Best Available Therapy, Including Ruxolitinib, in Patients With Myelofibrosis: A Randomized Clinical Trial. JAMA Oncol. 2018 May 1;4(5):652-659. doi: 10.1001/jamaoncol.2017.5818. **PMID:** 29522138 **Citation:** Stemline Therapeutics, Inc. ELZONRIS (Tagraxofusp-erzs) Investigator's Brochure Version 6.0 dated 04-20-2021 **Citation:** CTI Biopharma Corp. Pacritinib (SB1518) Investigator Brochure (IND 78,4806) Version 13 dated 02-27-2020 **Citation:** Stemline Therapeutics. Tagraxofusp Protocol Guidance for the Investigator. Version 2.0 dated 09-29-2021. Provided by Stemline Therapeutics **Citation:** CTI Biopharma Corp. VONJO (Pacritinib) Package Insert dated 02-2022 **Citation:** Stemline Therapeutics, Inc. Protocol Number STML-401-0314 Amendment 8 dated 05-05-2020. Tagraxofusp (SL-401) in Patients with Chronic Myelomonocytic Leukemia (CMML) or Myelofibrosis (MF) #### See Also Links **Label:** The Impact of Pacritinib on Myelofibrosis Symptoms in Patients with Moderate and Severe Thrombocytopenia: A Retrospective Analysis of Patients in the Persist-2 Study. Blood (2021) 138 (Supplement 1): 3628. **URL:** https://doi.org/10.1182/blood-2021-144505 **Label:** U.S Food and Drug Administration - News and Events for Human Drugs. FDA approves drug for adults with rare form of bone marrow disorder **URL:** https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-adults-rare-form-bone-marrow-disorder **Label:** Pacritinib Granted Accelerated Approval for Use in Myelofibrosis With Severe Thrombocytopenia **URL:** https://www.cancernetwork.com/view/Pacritinib-granted-accelerated-approval-for-use-in-myelofibrosis-with-severe-thrombocytopenia **Label:** Indiana University School of Medicine, Department of Medicine, Clinical Pharmacology. Drug Interaction Flockhart Table **URL:** http://medicine.iupui.edu/clinpharm/ddis/table.asp **Label:** U.S. Food \& Drug Administration. For Healthcare Professionals \| FDA's Examples of Drugs that Interact with CYP Enzymes and Transporter Systems **URL:** https://www.fda.gov/drugs/drug-interactions-labeling/healthcare-professionals-fdas-examples-drugs-interact-cyp-enzymes-and-transporter-systems **Label:** Results of the Persist-2 Phase 3 Study of Pacritinib (PAC) Versus Best Available Therapy (BAT), Including Ruxolitinib (RUX), in Patients (pts) with Myelofibrosis (MF) and Platelet Counts \<100,000/µl. Blood. Volum **URL:** https://doi.org/10.1182/blood.V128.22.LBA-5.LBA-5 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009196 - Term: Myeloproliferative Disorders - ID: D000001855 - Term: Bone Marrow Diseases - ID: D000006402 - Term: Hematologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M28312 - Name: Primary Myelofibrosis - Relevance: HIGH - As Found: Myelofibrosis - ID: M12149 - Name: Myeloproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M5134 - Name: Bone Marrow Diseases - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: T4705 - Name: Primary Myelofibrosis - Relevance: HIGH - As Found: Myelofibrosis - ID: T1311 - Name: Chronic Myeloproliferative Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000055728 - Term: Primary Myelofibrosis ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1474 - Name: Janus Kinase Inhibitors - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414668 **Acronym:** ENERGYCO **Brief Title:** The ENERGYCO Study **Official Title:** ENERGY Expenditure of COmmuting to School #### Organization Study ID Info **ID:** ENERGYCO #### Organization **Class:** OTHER **Full Name:** Universidad de Granada ### Status Module #### Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2023-02-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Ministerio de Economía y Competitividad, Spain **Class:** OTHER **Name:** University of Jaén **Class:** UNKNOWN **Name:** Navarra Institute for Health Research **Class:** UNKNOWN **Name:** Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y Nutrición **Class:** OTHER **Name:** University of Otago #### Lead Sponsor **Class:** OTHER **Name:** Universidad de Granada #### Responsible Party **Investigator Affiliation:** Universidad de Granada **Investigator Full Name:** Emilio Villa González **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aims of this school-based cycling intervention called "ENERGY Commuting to school" (ENERGYCO) will be divided into two phases: Phase I will aim: 1) to design, test, and validate predictive equations for the objective quantification of the energy expenditure related to different modes of commuting to school (i.e., walking, cycling, motorized-vehicle); and 2) to quantify the energy expenditure of each mode of commuting to school using indirect calorimetry in adolescents; and Phase II will aim to evaluate the effect of a school-based cycling intervention on different health-related outcomes, such as energy expenditure, resting metabolic rate, basal metabolism, physical activity levels, body composition, muscle strength, cardiorespiratory fitness, blood pressure, physical literacy, motor competence, and psychosocial outcomes on Spanish adolescents. **Detailed Description:** The ENERGYCO study is a cluster-randomized controlled trial focused on the energy expenditure associated with commuting to school. Phase I will aim to develop predictive equations for quantifying energy expenditure during different modes of commuting (walking, cycling, motorized-vehicle) and to measure energy expenditure using indirect calorimetry in adolescents. Phase II will assess the impact of a school-based cycling intervention on various health outcomes in Spanish adolescents, including energy expenditure, metabolic rate, physical activity levels, body composition, muscle strength, fitness, blood pressure, physical literacy, motor competence, and psychosocial outcomes. Phase I will involve recruiting approximately 50 adolescents to quantify energy expenditure during walking, cycling, and motorized-vehicle. For Phase II, a random sample of around 300 schoolchildren aged 12-16 from three Spanish cities will undergo a eight-week cycling intervention involving Bikeability sessions and encouragement strategies. Therefore, the ENERGYCO study aims to develop predictive equations for measuring energy expenditure during active commuting to school and assess the impact of a cycling intervention on adolescent health. It is expected to contribute significantly to research and society by providing insights into the effects of active commuting and cycling interventions on adolescent energy expenditure, physical and mental health. ### Conditions Module **Conditions:** - Energy Expenditure - Physical Activity - Behavior - Body Composition **Keywords:** - Resting metabolic rate - Energy expenditure - Physical activity - Body composition - Cycling - School ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The intervention will include two Bikeability sessions and encouragements strategies will be carried out to complete the eight-weeks intervention based on cycling to and from school **Intervention Names:** - Behavioral: Cycling Intervention Group **Label:** Cycling group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The control group will keep their usual mode of commuting to and from school. **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Cycling group **Description:** A eight-weeks school-based cycling program. The school-based cycling intervention consists of 2 Bikeability sessions of 60 min at Physical Education lessons in school, and will focus on promote biking through theory and practice lessons about cycle training skills including on-road training. In addition, participants will receive encouragement strategies, one for each week of the intervention, for cycling to and from school during eight weeks. **Name:** Cycling Intervention Group **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Assessment of the resting metabolic rate using indirect calorimetry (Ominical) **Measure:** Change of the resting metabolic rate **Time Frame:** 8 weeks during both measurement points (Baseline and post-intervention) **Description:** Assessment of the energy expenditure using predictive equations developed during the Phase I of the stuy and validated against indirect calorimetry (Cosmed K5) **Measure:** Change of the daily energy expenditure **Time Frame:** 8 weeks during both measurement points (Baseline and post-intervention) #### Secondary Outcomes **Description:** Assessment of the physical activity levels using accelerometry and the "Youth Physical Activity Profile" questionnaire **Measure:** Change of Physical activity levels **Time Frame:** 8 weeks during both measurement points (Baseline and post-intervention) **Description:** Assessment of the intensity of the commuting by bike to and from school using a pulsometer **Measure:** Heart rate monitoring **Time Frame:** During the 8 weeks when the participant will cycle to and from school **Description:** Assessment of the resting heart rate using a pulsometer **Measure:** Resting heart rate monitoring **Time Frame:** First weekend of the school-based cycling intervention **Description:** Assessment of the cycling skills in a closed circuit **Measure:** Cycling skill assessment: Bikeability sessions **Time Frame:** First week of the school-based cycling intervention **Description:** Assessment of cardiorespiratory fitness (Course Navette), muscular strength (analog dinamometer), and blood pressure (stethoscope ) **Measure:** Change of physical fitness **Time Frame:** 8 weeks during both measurement points (Baseline and post-intervention) **Description:** Assesment of phsychological, social, cognitive, and motor competence using the Spanish perceived physical literacy instrument for adolescents (PPLI-Q) and the Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) **Measure:** Change of physical literacy **Time Frame:** 8 weeks during both measurement points (Baseline and post-intervention) **Description:** Assessment of height and weight, (e.g., weight and height will be combined to report BMI in kg/m\^2) **Measure:** Change of anthropometric measures **Time Frame:** 8 weeks during both measurement points (Baseline and post-intervention) **Description:** Assessment of waist and neck circumference in centimeters **Measure:** Change of anthropometric measures **Time Frame:** 8 weeks during both measurement points (Baseline and post-intervention) **Description:** Assessment of fat free mass, fat mass, lean mass index, fat mass index, body fat percentage, visceral adipose tissue, and bone mineral content using Dual energy X-ray absorptimetry (DEXA) **Measure:** Change of body composition **Time Frame:** 8 weeks during both measurement points (Baseline and post-intervention) **Description:** Assessment of subjective norm, intention, perceived behavioral control and attitude using Questionnaire stages of change **Measure:** Change of cognitive determinants **Time Frame:** 8 weeks during both measurement points (Baseline and post-intervention) **Description:** Assessment of perceived barriers to active commute to school using the Barriers for active commuting to school questionnaire (BATACE) **Measure:** Change of perceptions to active commuting to and from school **Time Frame:** 8 weeks during both measurement points (Baseline and post-intervention) **Description:** Assessment of autonomy, competence, and relatedness using the Basic Pshychological Need Satisfaction Need in Active Commuting to and from School questionnaire (BPNS ACS) **Measure:** Change in children's psychosocial variables **Time Frame:** 8 weeks during both measurement points (Baseline and post-intervention) **Description:** Assessment of satisfaction and motivation to active commuting to and from school using the Behavioural Regulation in Active Commuting to and from School questionnaire **Measure:** Change in children's psychosocial variables **Time Frame:** 8 weeks during both measurement points (Baseline and post-intervention) **Description:** Assessment of self-Esteem and mental health using the Positive and Negative Affect Schedule and the Rosenberg Self-Esteem Scale (RSES) **Measure:** Change in children's psychosocial variables **Time Frame:** 8 weeks during both measurement points (Baseline and post-intervention) **Description:** Participants self-report their age, school grade and class, gender, full postal address, bicycle owners through a student questionnaire **Measure:** Children sociodemographic characteristics **Time Frame:** 8 weeks during both measurement points (Baseline and post-intervention) **Description:** Parents self-report the school name, child name, age, gender, children´s gender, and full postal address, parental education level through a parents questionnaire **Measure:** Parents sociodemographic characteristics **Time Frame:** 8 weeks during both measurement points (Baseline and post-intervention) **Description:** Children and parents self-report their family income using the Family Affluence Scale questionnaire (FAS III) **Measure:** Family socioeconomic status **Time Frame:** 8 weeks during both measurement points (Baseline and post-intervention) **Description:** Assessment of the parents´ barriers to allow their adolescent to active commuting to and from school using the Parental Perception of Barriers towards active commuting to school questionnaire (PABACS) **Measure:** Change of parental perceptions **Time Frame:** 8 weeks during both measurement points (Baseline and post-intervention) **Description:** Assessment of the route characteristics using Google Maps and GPS **Measure:** Distance home-school-home **Time Frame:** 8 weeks during both measurement points (Baseline and post-intervention) **Description:** Assessment of the Temperature (maximum, minimum, mean), total rainfall, and mean wind speed using data from the National Weather Data Bank **Measure:** Weather **Time Frame:** 8 weeks during both measurement points (Baseline and post-intervention) **Description:** Assessment of the school enrolment by electronic and manual search **Measure:** School characteristics **Time Frame:** 8 weeks during both measurement points (Baseline and post-intervention) **Description:** Assessment of the school socioeconomic status using Geographical Information System **Measure:** School characteristics **Time Frame:** 8 weeks during both measurement points (Baseline and post-intervention) **Description:** Assessment of the school engagement using data from the Ministry of Education and Vocational Training **Measure:** School characteristics **Time Frame:** 8 weeks during both measurement points (Baseline and post-intervention) **Description:** Assessment of the population density and city income using data from the Tax Agency, Spanish Public Ministry of Finance and Public Administration of Spain **Measure:** City characteristics **Time Frame:** 8 weeks during both measurement points (Baseline and post-intervention) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. the school has a specific space for parking bicycles and allows for their parking 2. the school does not have a specific school bus route 3. the school has at least two lines per class 4. at least eight students from the school will agree to participate in the study (i.e., presenting a signed parental consent). **Healthy Volunteers:** True **Maximum Age:** 17 Years **Minimum Age:** 12 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Granada **Contacts:** ***Contact 1:*** - **Email:** evilla@ugr.es - **Name:** Emilio Villa-González, PhD - **Phone:** 637942790 - **Role:** CONTACT **Country:** Spain **Facility:** University of Granada **Status:** RECRUITING **Zip:** 18071 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414655 **Acronym:** ChiTwiMC **Brief Title:** Multicenter Prospective Cohort Study of Twin Maternal-Child Dyads in China **Official Title:** Multicenter Prospective Cohort Study of Twin Maternal-Child Dyads in China #### Organization Study ID Info **ID:** ChiTwiMC #### Organization **Class:** OTHER **Full Name:** Peking University Third Hospital ### Status Module #### Completion Date **Date:** 2026-11-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-11-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-03-17 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** First Affiliated Hospital, Sun Yat-Sen University **Class:** OTHER **Name:** Chongqing Medical University **Class:** OTHER **Name:** Shengjing Hospital **Class:** OTHER **Name:** Peking University **Class:** OTHER **Name:** Nankai University **Class:** OTHER **Name:** Shanghai First Maternity and Infant Hospital **Class:** OTHER **Name:** The First Affiliated Hospital of Anhui Medical University **Class:** OTHER **Name:** International Peace Maternity and Child Health Hospital **Class:** OTHER **Name:** The Second Hospital of Shandong University **Class:** OTHER_GOV **Name:** Shandong Provincial Hospital #### Lead Sponsor **Class:** OTHER **Name:** Peking University Third Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Multicenter Prospective Cohort Study of Twin Maternal-Child Dyads in China (ChiTwiMC) is supported by National Key Research and Development Program of China - Reproductive Health and Women's and Children's Health Protection Project. This project is funded by the Ministry of Science and Technology of China under grant number 2023YFC2705900. The ChiTwiMC cohort is led by Professor Wei Yuan from the Department of Gynecology and Obstetrics at Peking University Third Hospital. **Detailed Description:** The ChiTwiMC Cohort focusing on the serious complications of twin pregnancy, establish a multicenter large prospective mother-child cohort of twin pregnancy covering pregnancy→neonatal period→early childhood, and a multi-variety, multi-stage biobank for the study of adverse outcomes of twin pregnancy. The ChiTwiMC Cohort is planning to recruit 2000 pregnant women aged 18-45 years from 9 large obstetrical center of major University-affiliated Hospitals across China, between December 2023 and May 2026. All women will be enrolled prior to 14 wks of gestation, pregnancy was followed up at 22-28 wks, 30-38 wks of gestation, delivery, postpartum 42 days, 6 months, 12 months. Data including demographics, medical history, reproductive history, clinical diagnosis, treatment information, and pregnancy and birth outcomes will be collected via electronic data capture system. Track the outcome of severe maternal-fetal complications and early neonatal outcomes of twins, and collect biological samples, including peripheral venous blood, hair and cervicovaginal secretions from pregnant women, placenta tissue, amniotic fluid and unbilical cord blood at delivery, meconium and hair from newborns, buccal mucosa from infants and peripheral venous blood from the husband. ### Conditions Module **Conditions:** - Twin Pregnancy, Antepartum Condition or Complication - Twin to Twin Transfusion as Antepartum Condition - Pre-Term - Pre-Eclampsia - Twin Monochorionic Diamniotic Placenta - Twin Dichorionic Diamniotic Placenta - High Risk Pregnancy - Twin Placenta ### Design Module #### Bio Spec **Description:** Collecting peripheral venous blood from husband, hair during the first trimester, peripheral venous blood and cervicovaginal secretions during the first trimester, second trimester, late pregnancy before labor, placental tissue, amionic fluid and umbilical cord blood during delivery, hair, meconium of newborns, and buccal mucosa from infants. **Retention:** NONE_RETAINED #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 2000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Preterm delivery is defined as delivery between 28 and 37 gestational weeks. **Measure:** Rate of preterm delivery **Time Frame:** From inclusion to delivery **Description:** Preeclampsia is defined as the condition occurring in pregnant women after 20 weeks of gestation, characterized by systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, accompanied by any of the following: a urinary protein quantification ≥0.3 g/24 h, or a urine protein/creatinine ratio ≥0.3, or random urine protein ≥ (+) (as a method of examination when protein quantification is not feasible). In the absence of proteinuria, the condition may still be diagnosed if there is involvement of any organ or system, including but not limited to critical organs such as the heart, lungs, liver, kidneys, or abnormalities in the hematological, digestive, or neurological systems, as well as complications affecting the placenta-fetus. **Measure:** Rate of preeclampsia **Time Frame:** From inclusion to delivery **Description:** TTTS is diagnosed in monochorionic diamniotic twin pregnancies when there is a discordance in amniotic fluid volumes, with one fetus exhibiting polyhydramnios and the other oligohydramnios. Specifically, before 20 weeks of gestation, the condition is diagnosed if one fetus (the recipient) has a deepest vertical pocket (DVP) of amniotic fluid ≥8cm, while the other fetus (the donor) has a DVP ≤2cm; after 20 weeks of gestation, the diagnosis is made if one fetus (the recipient) has a DVP ≥10cm, while the other fetus (the donor) has a DVP ≤2cm. **Measure:** Rate of twin-to-twin transfusion syndrome (TTTS) **Time Frame:** From inclusion to delivery **Description:** sFGR is diagnosed in monochorionic diamniotic twin pregnancies when one fetus has an estimated fetal weight below the 10th percentile for its gestational age, and there is a discrepancy of ≥25% in the estimated fetal weights between the two fetuses. **Measure:** Rate of selective fetal growth restriction (sFGR) **Time Frame:** From inclusion to delivery **Description:** Fetal brain injury is an abnormality in the structural and functional integrity of the cerebrum, cerebellum, or brainstem during the gestational period, caused by various factors such as hypoxic-ischemic events, infections, hemorrhage, congenital malformations, and genetic metabolic disorders. **Measure:** Rate of fetal brain injury **Time Frame:** From inclusion to delivery **Description:** Brain injury refers to damage to the central nervous system resulting from various risk factors during pregnancy, childbirth, and the neonatal period. Clinically, it manifests as central motor disorders, cognitive impairments, language disorders, visual and auditory impairments, as well as difficulties in social interaction and psychological and behavioral disorders. It needs pregnant history or birth history, (such as one of twin intrauterine fetal death, Intrauterine distress), manifestation, and ultrasound, CT, MRI, electroencephalogram to make a definite diagnosis. **Measure:** Rate of neonatal brain injury **Time Frame:** From inclusion to delivery **Description:** Early childhood developmental delay of the offspring refers to a significant lag or delay in achieving age-appropriate developmental milestones across one or more domains, including cognitive, language, motor, social-emotional, and adaptive skills, during the early years of life (typically from birth to 5 years of age) in comparison to established norms or peers. The assessment of early childhood developmental delay is conducted using standardized scales such as Ages Stages Questionnaires (Third Edition), Gesell Developmental Schedules, and Bayley Scales of Infant and Toddler Development. The actual measurement process will be depending on the routine pediatric settings and resources available at each participating institution. **Measure:** Rate of early childhood developmental delay of the offspring **Time Frame:** Within 1 year after delivery **Description:** Each child is measured twice. If the difference is less than 0.1 cm, the average of the two measurements is taken. If the difference is greater than 0.1 cm, the measurement is repeated. **Measure:** Children's height **Time Frame:** Within 1 year after delivery **Description:** Each newborn is measured twice. If the difference is less than 0.01 kg, the average of the two measurements is taken. If the difference is greater than 0.01 kg, the measurement is repeated. **Measure:** Children's weight **Time Frame:** Within 1 year after delivery #### Secondary Outcomes **Description:** Women's physiological and psychological changes during pregnancy will affect sleep, and the occurrence of bad sleep during pregnancy is more common. It is generally assessed by a sleep questionnaire. **Measure:** Rate of sleep disorders **Time Frame:** From inclusion to delivery **Description:** Maternal mental health is as important as physical health, and good maternal mental health helps to promote the physical and mental health of the baby, as well as their own physical condition and natural childbirth. The condition of pregnant women is generally assessed by psychiatric departments. **Measure:** Rate of mental and phycological disorders **Time Frame:** From inclusion to delivery **Description:** The death of one fetus for twin pregnancy，the occurrence in the second and third trimesters of pregnancy has substantial adverse effects on surviving infants. **Measure:** Rate of single intrauterine fetal demise **Time Frame:** From inclusion to delivery **Description:** Take two consecutive measurements on the same arm, the systolic blood pressure more than 140 mmHg and (or) the diastolic blood pressure more than 90 mmHg. High blood pressure may lead to severe complications such as preclampsia and clampsia. **Measure:** Rate of gestational hypertension **Time Frame:** From inclusion to delivery **Description:** Diagnosed with gestational diabetes through an oral glucose tolerance test (OGTT). The blood glucose threshold of fasting, 1 h and 2 h after taking oral glucose was 5.1, 10.0, 8.5 mmolL, respectively, and the blood glucose level reached or exceeded the above criteria at any time point was diagnosed as GDM. GDM is clearly associated with adverse pregnancy outcomes such as fetal macrosomia, cesarean section delivery, preterm birth, and preeclampsia **Measure:** Rate of gestational diabetes mellitus **Time Frame:** From inclusion to delivery **Description:** Deaths during pregnancy or less than 42 days after termination of pregnancy. **Measure:** Number of maternal death **Time Frame:** From inclusion to delivery **Description:** After 28 gestational weeks, the fetus dies before or during delivery **Measure:** Rate of stillbirth **Time Frame:** From inclusion to delivery **Description:** Each newborn is measured twice. If the difference is less than 0.01 kg, the average of the two measurements is taken. If the difference is greater than 0.01 kg, the measurement is repeated. **Measure:** Birth weight **Time Frame:** At delivery **Description:** Each newborn is measured twice. If the difference is less than 0.1 cm, the average of the two measurements is taken. If the difference is greater than 0.1 cm, the measurement is repeated. **Measure:** Birth length **Time Frame:** At delivery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Twin pregnancies * Female aged between 18-45 years * Gestational age is less than 14 weeks * Planning to receive prenatal healthcare and delivery service at the study hospital * Signing informed concent and willing to participate Exclusion Criteria: * Women with mental disorders or serious maternal illness that is not eligible to participate * Inability to provide informed consent * Pregnant women not registered in our hospital **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT **Study Population:** The ChiTwiMC is a prospective cohort that will enroll 2000 pregnant women aged 18-45 years and over from 9 large obstetrical centers of University-Affiliated Hospitals (Peking University Third Hospital; First Affiliated Hospital, Sun Yat-Sen University; Chongqing Medical University; Shengjing Hospital; Shanghai First Maternity and Infant Hospital; The First Affiliated Hospital of Anhui Medical University; International Peace Maternity and Child Health Hospital; The Second Hospital of Shandong University; Shandong Provincial Hospital). These hospitals located at 7 supercities (Beijing, Shanghai, Guangzhou, Shenyang, Jinan, Chongqing, and Hefei) of China. Pregnant women who are planning to receive prenatal healthcare and delivery in those hospitals are potential candidates for the study. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** weiyuanbysy@163.com **Name:** Yuan Wei, PhD, MD **Phone:** 01082267852 **Role:** CONTACT **Contact 2:** **Email:** wtc17@pku.edu.cn **Name:** Tianchen Wu, PhD **Role:** CONTACT #### Locations **Location 1:** **City:** Hefei **Contacts:** ***Contact 1:*** - **Email:** dr_yinzongzhi@qq.com - **Name:** Zongzhi Yin - **Role:** CONTACT **Country:** China **Facility:** The First Affiliated Hospital of Anhui Medical University **State:** Anhui **Status:** RECRUITING **Zip:** 230001 **Location 2:** **City:** Peking **Contacts:** ***Contact 1:*** - **Email:** weiyuanbysy@163.com - **Name:** Yuan Wei, PhD, MD - **Role:** CONTACT ***Contact 2:*** - **Email:** wtc17@pku.edu.cn - **Name:** Tianchen Wu, PhD - **Role:** CONTACT **Country:** China **Facility:** Peking University Third Hospital **State:** Beijing **Status:** RECRUITING **Zip:** 100191 **Location 3:** **City:** Peking **Contacts:** ***Contact 1:*** - **Email:** xlwang@bjmu.edu.cn - **Name:** Xiaoli Wang - **Role:** CONTACT **Country:** China **Facility:** Peking University **State:** Beijing **Status:** RECRUITING **Zip:** 10091 **Location 4:** **City:** Chongqing **Contacts:** ***Contact 1:*** - **Email:** dingyb@cqmu.edu.cn - **Name:** Yubin Ding - **Role:** CONTACT **Country:** China **Facility:** Chongqing Medical University **State:** Chongqing **Status:** RECRUITING **Zip:** 400010 **Location 5:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Email:** luoyanm@mail.sysu.edu.cn - **Name:** Yanmin Luo - **Role:** CONTACT **Country:** China **Facility:** First Affiliated Hospital, Sun Yat-Sen University **State:** Guangdong **Status:** RECRUITING **Zip:** 510000 **Location 6:** **City:** Shenyang **Contacts:** ***Contact 1:*** - **Email:** Weij@sj-hospital.org - **Name:** Jun Wei - **Role:** CONTACT **Country:** China **Facility:** Shengjing Hospital **State:** Liaoning **Status:** RECRUITING **Zip:** 110000 **Location 7:** **City:** Jinan **Contacts:** ***Contact 1:*** - **Email:** adokemeng@163.com - **Name:** Jinlai Meng - **Role:** CONTACT **Country:** China **Facility:** Shandong Provincial Hospital **State:** Shandong **Status:** RECRUITING **Zip:** 250021 **Location 8:** **City:** Jinan **Contacts:** ***Contact 1:*** - **Email:** hongfz@sdu.edu.cn - **Name:** Fanzhen Hong - **Role:** CONTACT **Country:** China **Facility:** The Second Hospital of Shandong University **State:** Shandong **Status:** RECRUITING **Zip:** 250033 **Location 9:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Email:** wyanlin@163.com - **Name:** Yanlin Wang - **Role:** CONTACT **Country:** China **Facility:** International Peace Maternity and Child Health Hospital **State:** Shanghai **Status:** RECRUITING **Zip:** 200030 **Location 10:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Email:** zougangshcn@sina.com - **Name:** Gang Zou - **Role:** CONTACT **Country:** China **Facility:** Shanghai First Maternity and Infant Hospital **State:** Shanghai **Status:** RECRUITING **Zip:** 201204 **Location 11:** **City:** Tianjin **Contacts:** ***Contact 1:*** - **Email:** lshuai@nankai.edu.cn - **Name:** Ling Shuai - **Role:** CONTACT **Country:** China **Facility:** Nankai University **State:** Tianjin **Status:** RECRUITING **Zip:** 300071 #### Overall Officials **Official 1:** **Affiliation:** Obstetrics and Gynecology Department of Peking University Third Hospital **Name:** Yuan Wei, PhD, MD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Description:** We have decided that the program will be confidential and not open to other researchers **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000046110 - Term: Hypertension, Pregnancy-Induced - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000000751 - Term: Anemia, Neonatal - ID: D000000740 - Term: Anemia - ID: D000006402 - Term: Hematologic Diseases - ID: D000007232 - Term: Infant, Newborn, Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M7633 - Name: Eclampsia - Relevance: HIGH - As Found: Eclampsia - ID: M14106 - Name: Pre-Eclampsia - Relevance: HIGH - As Found: Pre-Eclampsia - ID: M25869 - Name: Premature Birth - Relevance: LOW - As Found: Unknown - ID: M8460 - Name: Fetofetal Transfusion - Relevance: HIGH - As Found: Twin to Twin Transfusion - ID: M10024 - Name: Hypertension - Relevance: LOW - As Found: Unknown - ID: M25635 - Name: Hypertension, Pregnancy-Induced - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M4070 - Name: Anemia - Relevance: LOW - As Found: Unknown - ID: M4081 - Name: Anemia, Neonatal - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M10276 - Name: Infant, Newborn, Diseases - Relevance: LOW - As Found: Unknown - ID: T2019 - Name: Eclampsia - Relevance: HIGH - As Found: Eclampsia - ID: T5768 - Name: Twin to Twin Transfusion Syndrome - Relevance: HIGH - As Found: Twin to Twin Transfusion ### Condition Browse Module - Meshes - ID: D000004461 - Term: Eclampsia - ID: D000011225 - Term: Pre-Eclampsia - ID: D000005330 - Term: Fetofetal Transfusion - ID: D000004194 - Term: Disease ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414629 **Acronym:** SBMP **Brief Title:** An Implementation Research of Simulation Based Mentorship Program **Official Title:** Implementation and Evaluation of Simulation-Based Mentorship Program (SBMP) in Nepal Using the RE-AIM Framework #### Organization Study ID Info **ID:** OHW1 #### Organization **Class:** OTHER **Full Name:** One Heart Worldwide ### Status Module #### Completion Date **Date:** 2023-12-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-12-31 **Type:** ACTUAL #### Start Date **Date:** 2020-11-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** One Heart Worldwide #### 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 goal of this research was to evaluate the effectiveness and implementation outcomes of the Simulation Based Mentorship Program (SBMP) which was implemented in four districts of Nepal. The main questions it aims to answer are: 1. What is the reach of the Simulation Based Mentorship Program? 2. What is the effect of Simulation Based Based Mentorship Program on knowledge, clinical skills, and confidence of nurses working in Birthing Centers of four district of Nepal? 3. How was the program adopted by the Birthing Centers? 4. How was the program implemented? 5. What is the perception regarding the maintenance of the program? The nurses working in the Birthing Centers were the study participants, and they received simulation-based monthly mentorship on following seven modules related to essential obstetric and newborn care every month: 1. Infection prevention 2. Antenatal care and counseling 3. Essential care of labor and birth 4. Helping babies breathe 5. Bleeding after birth 6. Pre-eclampsia and eclampsia management 7. Postnatal care and counseling **Detailed Description:** As the evidence showed gaps in the knowledge and skills of existing maternal and newborn health providers, we designed a Simulation-Based Mentorship Program (SBMP) to bridge the gaps. In this program, local-level mentors were developed to provide regular mentorship using a low-dose high-frequency approach in contrast to one-time coaching in a long gap. This program combined the existing package of the continuum of care along with Helping Babies Survive (HBS) \& Helping Mothers Survive (HMS) guidelines, adopting a simulation-based onsite mentoring and coaching approach. The main aim of this mentorship program was to improve the quality of essential obstetric and newborn care provided by the nurses and Auxiliary Nurse Midwives (ANMs) irrespective of their pre-service and in-service training exposure by identifying gaps, providing regular technical support on the site, building close relationships between mentors and mentees, and increasing communication, backed up by regular practice in simulation labs to help in skill retention. In this mentorship program, mentorship was provided to both the Skilled Birth Assistants (SBAs) and non-Skilled Birth Attendants in their workstations to capacitate them in promoting mother and newborn health outcomes. Reach, Effectiveness, Adoption, Implementation, and Maintenance (REAIM) Dimensions in the study were: Reach 1. Number and percentage of Birthing centers intervened in the district 2. Number and percentage of nurses trained as district-level mentors 3. Number and percentage of nurses (and Auxiliary Nurse Midwives) receiving the intervention (simulation-based mentorship) 4. Perception regarding the representativeness of participants in the program Effectiveness 1. Immediate change in knowledge, skills, and confidence (midline results)- compared with control group 2. Perceived reasons for program effectiveness Adoption 1. Number and percentage of intervention sites completing all 6 monthly sessions 2. Number and percentage of mentees participating in all 6 monthly sessions 3. Number and percentage of mentees participating in weekly sessions 4. Reasons for participation/ non-participation Implementation 1. Plan vs. actual implementation (duration between monthly sessions) 2. Perception regarding various components of the program (content, teaching and learning methods, mentors) 3. Challenges encountered during implementation, adaptations made/ mitigation measures adopted Maintenance 1. Number and percentage of mentors and mentees remaining after 4 to 6 months of Simulation Based Mentorship Program (SBMP) implementation (end-line) 2. Retention of knowledge, skills, and confidence 4 to 6 months after completion of the intervention (end-line results) compared with the control group 3. Capital cost and recurrent cost required for continuation at government level 4. Application of learnings in a real setting (during and after the program implementation) 5. Willingness to implement the program in the health facilities of Simulation Based Mentorship Program (SBMP) implemented local levels after completion of the intervention 6. Continuation of mentoring/ learning in the simulation labs/ using manikins after completion of monthly sessions by mentors and mentees 7. Challenges and recommendations for continuation ### Conditions Module **Conditions:** - Maternal Health - Neonatal Health **Keywords:** - Simulation - Mentorship - Capacity building ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The study Birthing Centers were categorized into Intervention Birthing Center and Control Birthing Center ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 326 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The nurses working in the Intervention Birthing Centers received the Simulation Based Mentorship Program. **Intervention Names:** - Other: Simulation Based Mentorship Program **Label:** Intervention Group/ Intervention Birthing Center **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The nurses working in the Intervention Birthing Centers did not receive the Simulation Based Mentorship Program. **Label:** Control Group/ Control Birthing Center **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention Group/ Intervention Birthing Center **Description:** In this program, local level mentors were developed to provide regular mentorship on low-dose high-frequency approach in contrast to one-time coaching in a long gap. This program combined the existing package of the continuum of care along with Helping Babies Survive (HBS) \& Helping Mothers Survive (HMS) guidelines, adopting a simulation-based onsite mentoring and coaching approach. The mentors provided monthly mentorship on following seven modules topics to the nurses of the intervention birthing centers: 1. Infection prevention 2. Antenatal care and counseling 3. Essential care of labor and birth 4. Helping babies breathe 5. Bleeding after birth 6. Essential care of labor and birth 7. Postnatal care and counseling Every monthly session was followed by four weekly practice sessions. The nurses from intervention birthing centers were also called mentees. **Name:** Simulation Based Mentorship Program **Other Names:** - SBMP **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The knowledge and confidence scores of intervention and control group's nurses in all seven modules were compared before and after the study. However, skills scores of seven modules were measured only in intervention group's nurses. The overall maximum obtainable score was 127 points for knowledge assessment, 210 points for confidence assessment, and 340 points for skills assessment. The scores obtained by the participants were expressed as percentage, and a mean score was calculated for each module. A score of 80% or more was considered to be appropriate. High scores indicated better outcome, and low scores indicated poor outcome. **Measure:** Knowledge, confidence and skills on seven modules **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Nurses working in selected Birthing Centers during the baseline enrollment Exclusion Criteria: * Newly recruited nurses by the Birthing Centers **Healthy Volunteers:** True **Maximum Age:** 49 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Kathmandu **Country:** Nepal **Facility:** One Heart Worldwide **State:** Bagmati #### Overall Officials **Official 1:** **Affiliation:** One Heart Worldwide **Name:** Surya Bhatta, MHCDS **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Utz B, Siddiqui G, Adegoke A, van den Broek N. Definitions and roles of a skilled birth attendant: a mapping exercise from four South-Asian countries. Acta Obstet Gynecol Scand. 2013 Sep;92(9):1063-9. doi: 10.1111/aogs.12166. Epub 2013 Jun 15. **PMID:** 23656549 **Citation:** Olson KR, Caldwell A, Sihombing M, Guarino AJ, Nelson BD, Petersen R. Assessing self-efficacy of frontline providers to perform newborn resuscitation in a low-resource setting. Resuscitation. 2015 Apr;89:58-63. doi: 10.1016/j.resuscitation.2015.01.008. Epub 2015 Jan 19. **PMID:** 25613363 **Citation:** Alamrani MH, Alammar KA, Alqahtani SS, Salem OA. Comparing the Effects of Simulation-Based and Traditional Teaching Methods on the Critical Thinking Abilities and Self-Confidence of Nursing Students. J Nurs Res. 2018 Jun;26(3):152-157. doi: 10.1097/jnr.0000000000000231. **PMID:** 29016466 **Citation:** Krielen P, Meeuwsen M, Tan ECTH, Schieving JH, Ruijs AJEM, Scherpbier ND. Interprofessional simulation of acute care for nursing and medical students: interprofessional competencies and transfer to the workplace. BMC Med Educ. 2023 Feb 11;23(1):105. doi: 10.1186/s12909-023-04053-2. **PMID:** 36774481 **Citation:** Barre J, Michelet D, Truchot J, Cabon P, Tesniere A. Midwifery students' retention of learning after screen-based simulation training on neonatal resuscitation: a pilot study. BMJ Simul Technol Enhanc Learn. 2020 Apr 6;7(1):31-34. doi: 10.1136/bmjstel-2019-000525. eCollection 2021. **PMID:** 35521074 **Citation:** Cant RP, Cooper SJ. Use of simulation-based learning in undergraduate nurse education: An umbrella systematic review. Nurse Educ Today. 2017 Feb;49:63-71. doi: 10.1016/j.nedt.2016.11.015. Epub 2016 Nov 22. **PMID:** 27902949 **Citation:** Lee BO, Liang HF, Chu TP, Hung CC. Effects of simulation-based learning on nursing student competences and clinical performance. Nurse Educ Pract. 2019 Nov;41:102646. doi: 10.1016/j.nepr.2019.102646. Epub 2019 Oct 23. **PMID:** 31698255 **Citation:** Hung CC, Kao HS, Liu HC, Liang HF, Chu TP, Lee BO. Effects of simulation-based learning on nursing students' perceived competence, self-efficacy, and learning satisfaction: A repeat measurement method. Nurse Educ Today. 2021 Feb;97:104725. doi: 10.1016/j.nedt.2020.104725. Epub 2020 Dec 16. **PMID:** 33373813 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414616 **Brief Title:** Real-World Evidence of Adherence to Denosumab Therapy and Fracture Risk Associated With Drug Withdrawal: A Cross-sectional Study **Official Title:** Are We Overly Concerned About Rebound Fractures? Real-World Evidence of Adherence to Denosumab Therapy and Fracture Risk Associated With Drug Withdrawal: A Cross-sectional Study #### Organization Study ID Info **ID:** 2022/343 #### Organization **Class:** OTHER **Full Name:** Trakya University ### Status Module #### Completion Date **Date:** 2024-03-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-05-01 **Type:** ACTUAL #### Start Date **Date:** 2022-10-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2022-12-06 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Trakya University #### Responsible Party **Investigator Affiliation:** Trakya University **Investigator Full Name:** Hande Ozdemir **Investigator Title:** Assoc. Prof. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** In the light of current literature data, it is not recommended to discontinue Denosumab therapy without initiating another antiresorptive therapy. It is known that there is a rebound increase in bone resorption markers and a rapid decrease in bone mineral density (BMD) when patients using Denosumab remain untreated for 1 year. The coronavirus disease (Covid-19) pandemic has caused an unprecedented disruption in the management of osteoporosis, as in many chronic diseases. This study aims to determine whether the risk of rebound-associated osteoporotic fracture development is increased in patients who discontinued Denosumab therapy due to any reason but especially due to hesitancy to come to hospitals or lack of access to treatment institutions during the pandemic period as well as to evaluate the factors affecting treatment compliance. **Detailed Description:** With increased life expectancy and decreased physical activity osteoporosis related fractures are increasing day by day which place a huge health economic burden on societies. Since fragility fractures and related disabilities bring about considerable morbidity and even mortality, the main goal in osteoporosis treatment is to prevent fractures. The facts that bisphosphonates can plateau after 3-4 years in the treatment response and Teriparatide cannot be used for more than 2 years, bring the use of Denosumab to the fore in patients with high fracture risk who need long term treatment. Denosumab is also preferred in patients with renal dysfunction since it is excreted by the reticuloendothelial system and not the kidney. However, there is a dilemma that publications in the literature mostly show that the risk of fracture development returns to a no-treatment status shortly after Denosumab withdrawal. Therefore, in this study it is aimed to examine whether there is statistically significant difference in terms of the risk of osteoporotic fracture development and other secondary outcome measures between the patient group who discontinued injections for more than 2 months and the patient group who regularly received their injections. In this study, patients who had commenced Denosumab in Trakya University Osteoporosis Polyclinic between 2015-2021 and had received at least 2 doses will be included. Demographic and clinical data will be retrospectively examined by the Physical Medicine and Rehabilitation physician at last date of follow-up through electronic medical records and patient files. Radiological images of the patients will also be examined whether there is radiological fracture before, under or after the treatment. The number of fractures and their localizations, if any, will be recorded. The number of Denosumab doses administered will be determined by review of the hospital's electronic prescription records. Adherence will be defined as being punctual (with an allowable delay of up to 8 weeks) with the 6 month scheduled doses. In addition, pre-treatment values of BMD as evaluated on dual energy x-ray absorptiometry (DXA), and Fracture Risk Assessment Tool (FRAX) scores will be recorded. In the light of the data obtained, the parameters affecting compliance and the effect of treatment compliance on the risk of osteoporotic fracture development will be presented to the literature. ### Conditions Module **Conditions:** - Osteoporosis **Keywords:** - Denosumab - Fragility fracture - Rebound fracture - Discontinuation - Osteoporosis ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 210 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** The number of new fragility fractures among Denosumab adherent and non-adherent patient groups as assessed by radiological images **Measure:** Number of new fragility fractures **Time Frame:** Through study completion, an average of 2 years #### Secondary Outcomes **Description:** The rate of Denosumab adherence and factors that may play a role in Denosumab adherence/non-adherence as assessed by restrospective examination of patient files which are age, sex, age of menopause, parity, marital status, occupation, height (cm), weight (kg), and body mass index (BMI) (kg/m2), family history of fragility fracture, presence of baseline fragility fractures before initiation of Denosumab treatment, comorbidities, use of steroids, smoking status, presence of secondary osteoporosis, tea/coffee/alcohol consumption status, consumption of dairy products, presence of any therapy before Denosumab, treatment agent before Denosumab, number of received Denosumab injections, duration of Denosumab withdrawal. **Measure:** Denosumab adherence rate and factors that may play a role in Denosumab adherence/non-adherence **Time Frame:** Through study completion, an average of 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 1. Patients who had received at least two consecutive doses of Denosumab ,with a gap of fewer than 8 months, with the diagnosis of osteoporosis. * 2. Patients who had at least one radiological image before the initiation of Denosumab therapy in which the lumbar and thoracic spine could be visualised * 3. Patients whose BMD and T-score values had been evaluated via DXA scan and FRAX scores had been calculated before the initiation of Denosumab therapy. Exclusion Criteria: * 1. Patients missing any of the above mentioned data * 2. Patients who develop fractures due to cancer, trauma or Paget's disease. * 3. Patients receiving monthly Denosumab to prevent bone metastasis. **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Patients initiated on Denosumab therapy at Trakya University Pyhsical Medicine and Rehabilitation Osteoporosis Unit between 2015-2021 and had received at least 2 doses of injection. ### Contacts Locations Module #### Locations **Location 1:** **City:** Edirne **Country:** Turkey **Facility:** Trakya University Medical Faculty **Zip:** 22030 #### Overall Officials **Official 1:** **Affiliation:** Trakya University **Name:** Hande Özdemir, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Lyu H, Jundi B, Xu C, Tedeschi SK, Yoshida K, Zhao S, Nigwekar SU, Leder BZ, Solomon DH. Comparison of Denosumab and Bisphosphonates in Patients With Osteoporosis: A Meta-Analysis of Randomized Controlled Trials. J Clin Endocrinol Metab. 2019 May 1;104(5):1753-1765. doi: 10.1210/jc.2018-02236. **PMID:** 30535289 **Citation:** Brown JP, Roux C, Torring O, Ho PR, Beck Jensen JE, Gilchrist N, Recknor C, Austin M, Wang A, Grauer A, Wagman RB. Discontinuation of denosumab and associated fracture incidence: analysis from the Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) trial. J Bone Miner Res. 2013 Apr;28(4):746-52. doi: 10.1002/jbmr.1808. **PMID:** 23109251 **Citation:** Black DM, Schwartz AV, Ensrud KE, Cauley JA, Levis S, Quandt SA, Satterfield S, Wallace RB, Bauer DC, Palermo L, Wehren LE, Lombardi A, Santora AC, Cummings SR; FLEX Research Group. Effects of continuing or stopping alendronate after 5 years of treatment: the Fracture Intervention Trial Long-term Extension (FLEX): a randomized trial. JAMA. 2006 Dec 27;296(24):2927-38. doi: 10.1001/jama.296.24.2927. **PMID:** 17190893 **Citation:** Sosa-Henriquez M, Torregrosa O, Deniz A, Saavedra P, Ortego N, Turrion A, Perez Castrillon JL, Diaz-Curiel M, Gomez-Alonso C, Martinez G, Antonio Blazquez J, Olmos-Martinez JM, Etxebarria I, Caeiro JR, Mora-Pena D. Multiple vertebral fractures after suspension of denosumab. A series of 56 cases. Int J Clin Pract. 2021 Oct;75(10):e14550. doi: 10.1111/ijcp.14550. Epub 2021 Jun 30. **PMID:** 34145944 **Citation:** Anastasilakis AD, Evangelatos G, Makras P, Iliopoulos A. Rebound-associated vertebral fractures may occur in sequential time points following denosumab discontinuation: need for prompt treatment re-initiation. Bone Rep. 2020 Apr 22;12:100267. doi: 10.1016/j.bonr.2020.100267. eCollection 2020 Jun. **PMID:** 32373677 **Citation:** Aubry-Rozier B, Gonzalez-Rodriguez E, Stoll D, Lamy O. Severe spontaneous vertebral fractures after denosumab discontinuation: three case reports. Osteoporos Int. 2016 May;27(5):1923-5. doi: 10.1007/s00198-015-3380-y. Epub 2015 Oct 28. **PMID:** 26510845 **Citation:** Niimi R, Kono T, Nishihara A, Hasegawa M, Kono T, Sudo A. Second rebound-associated vertebral fractures after denosumab discontinuation. Arch Osteoporos. 2020 Jan 2;15(1):7. doi: 10.1007/s11657-019-0676-0. **PMID:** 31898803 **Citation:** Fu SH, Wang CY, Hung CC, Lee CC, Yang RS, Huang CC, Farn CJ, Lin WH, Chen HM, Hsiao FY, Lin JW, Li CY. Increased fracture risk after discontinuation of anti-osteoporosis medications among hip fracture patients: A population-based cohort study. J Intern Med. 2021 Dec;290(6):1194-1205. doi: 10.1111/joim.13354. Epub 2021 Aug 2. **PMID:** 34237171 **Citation:** Cramer JA, Amonkar MM, Hebborn A, Altman R. Compliance and persistence with bisphosphonate dosing regimens among women with postmenopausal osteoporosis. Curr Med Res Opin. 2005 Sep;21(9):1453-60. doi: 10.1185/030079905X61875. **PMID:** 16197664 **Citation:** Chandran M, Hao Y, Kwee AK, Cheen MHH, Chin YA, Ng VYT. Adherence to dosing schedule of denosumab therapy for osteoporosis during COVID-19 lockdown: an electronic medical record and pharmacy claims database study from Asia. Osteoporos Int. 2022 Jan;33(1):251-261. doi: 10.1007/s00198-021-06085-0. Epub 2021 Aug 21. **PMID:** 34417842 **Citation:** Siris ES, Harris ST, Rosen CJ, Barr CE, Arvesen JN, Abbott TA, Silverman S. Adherence to bisphosphonate therapy and fracture rates in osteoporotic women: relationship to vertebral and nonvertebral fractures from 2 US claims databases. Mayo Clin Proc. 2006 Aug;81(8):1013-22. doi: 10.4065/81.8.1013. **PMID:** 16901023 **Citation:** Black DM, Delmas PD, Eastell R, Reid IR, Boonen S, Cauley JA, Cosman F, Lakatos P, Leung PC, Man Z, Mautalen C, Mesenbrink P, Hu H, Caminis J, Tong K, Rosario-Jansen T, Krasnow J, Hue TF, Sellmeyer D, Eriksen EF, Cummings SR; HORIZON Pivotal Fracture Trial. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med. 2007 May 3;356(18):1809-22. doi: 10.1056/NEJMoa067312. **PMID:** 17476007 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014947 - Term: Wounds and Injuries - ID: D000001851 - Term: Bone Diseases, Metabolic - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000008659 - Term: Metabolic Diseases - ID: D000019966 - Term: Substance-Related Disorders - ID: D000064419 - Term: Chemically-Induced Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC25 - Name: Substance Related Disorders - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M26370 - Name: Fractures, Bone - Relevance: HIGH - As Found: Fracture - ID: M12947 - Name: Osteoporosis - Relevance: HIGH - As Found: Osteoporosis - ID: M16162 - Name: Substance Withdrawal Syndrome - Relevance: HIGH - As Found: Drug Withdrawal - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M5130 - Name: Bone Diseases, Metabolic - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M21837 - Name: Substance-Related Disorders - Relevance: LOW - As Found: Unknown - ID: M30302 - Name: Chemically-Induced Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010024 - Term: Osteoporosis - ID: D000013375 - Term: Substance Withdrawal Syndrome - ID: D000050723 - Term: Fractures, Bone ### Intervention Browse Module - Browse Branches - Abbrev: BDCA - Name: Bone Density Conservation Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M417 - Name: Denosumab - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414603 **Acronym:** ACES-EMB **Brief Title:** A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance With Cell-free DNA Versus Endomyocardial Biopsy **Official Title:** A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance With Cell-free DNA Versus Endomyocardial Biopsy (ACES-EMB) #### Organization Study ID Info **ID:** 23-069-TRP #### Organization **Class:** INDUSTRY **Full Name:** Natera, Inc. ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-02 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Natera, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is an open label Comparative Effectiveness Research (CER) study in which patients will be randomized at the site level to Prospera surveillance or EMB surveillance in a 2:1 ratio (Prospera to EMB) at each site. Subjects will be enrolled into the study while under evaluation for heart transplantation or on the transplant waiting list prior to heart transplantation. All subjects will follow the center's standard of care surveillance schedule from transplant through 4 weeks post-transplantation. EMB during this phase is expected to occur roughly weekly or bi-weekly. Study group assignment will take place at randomization. Subjects will be randomized 30 days (± 10 days) post-transplant to Prospera surveillance versus EMB surveillance in a 2:1 ratio. Rejection surveillance (Prospera Group and EMB Group) will be performed at times corresponding to the institutional standard of care schedule for rejection surveillance. **Detailed Description:** All subjects will undergo standard of care assessments for rejection monitoring in addition to Prospera testing and/or EMB in accordance with each site's clinical care protocols and at the discretion of the treating clinician. Quality of life questionnaires will be completed at week 4, month 6 and month 12 post-transplant. Study Group: Prospera (dd-cfDNA) Surveillance Group Subjects are required to undergo Prospera testing at times corresponding to the institution's graft surveillance schedule. Prospera test results will be provided to the clinical team. Prospera cfDNA level \< 0.15% will be interpreted as low risk for acute rejection (AR). Prospera cfDNA ≥ 0.15% will be interpreted as increased risk for AR and may be followed by EMB to rule out AR at the discretion of the treating clinicians. All other standard of care modalities for assessing AR can be used at the discretion of the treating clinicians at any time throughout the study. As per standard of care, in subjects with clinical signs or symptoms of rejection, a for cause EMB can be done per the clinical team's discretion at any time during the study. Control Group: EMB Surveillance Group Subjects will undergo surveillance EMB per the institution's standard clinical care. Biopsy interpretation will be per the institutional pathologist using international guidelines for grading of acute cellular or antibody-mediated rejection. Subjects will also have Prospera testing performed at the time of surveillance EMB for the purpose of measuring concordance between dd-cfDNA surveillance testing and surveillance EMB; Prospera results will not be returned to investigators for subjects in the EMB surveillance group. Subjects in both the Prospera and EMB Surveillance Groups will have Prospera blood draws performed at the time of any for cause EMB. Results of Prospera testing performed in conjunction with for cause EMB will not be returned to investigators or subjects. Blood samples for exploratory mechanistic endpoints (miRNA) will be obtained at the time of each Prospera or EMB surveillance visit and at the time of any for cause EMB. The study period will be during the first 12 months post-transplant. ### Conditions Module **Conditions:** - Heart Transplant Failure and Rejection **Keywords:** - Heart Transplant ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 250 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects are required to undergo Prospera testing at times corresponding to the institution's graft surveillance schedule. Prospera test results will be provided to the clinical team. Prospera cfDNA level \< 0.15% will be interpreted as low risk for acute rejection (AR). Prospera cfDNA ≥ 0.15% will be interpreted as increased risk for AR and may be followed by EMB to rule out AR at the discretion of the treating clinicians. All other standard of care modalities for assessing AR can be used at the discretion of the treating clinicians at any time throughout the study. As per standard of care, in subjects with clinical signs or symptoms of rejection, a for cause EMB can be done per the clinical team's discretion at any time during the study. **Intervention Names:** - Diagnostic Test: The Prospera™ Test **Label:** Prospera Surveillance Cohort **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Subjects will undergo surveillance EMB per the institution's standard clinical care. Biopsy interpretation will be per the institutional pathologist using international guidelines for grading of acute cellular or antibody-mediated rejection. Subjects will also have Prospera testing performed at the time of surveillance EMB for the purpose of measuring concordance between dd-cfDNA surveillance testing and surveillance EMB; Prospera results will not be returned to investigators for subjects in the EMB surveillance group. **Label:** Endomyocardial Biopsy Surveillance Cohort **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Prospera Surveillance Cohort **Description:** The Prospera™ test is a non-invasive test intended to detect and quantify the fraction of donor-derived cell-free DNA (dd-cfDNA) to supplement management and surveillance of allograft rejection in patients who have undergone organ transplantation. It employs Next Generation Sequencing (NGS), which is performed on cell-free DNA (cfDNA) that is extracted from the patient's plasma to discriminate between the patient's DNA and the solid organ-allograft DNA. In study 23-069-TRP, the Prospera test is indicated for heart allograft rejection surveillance in lieu of surveillance endomyocardial biopsy. Prospera results should be considered together with clinical evaluations and other diagnostic testing or imaging results. Prospera will be run as a centralized laboratory developed test that is developed and validated under Design Controls. The test will be run within Natera's CLIA-certified and CAP-accredited laboratory. **Name:** The Prospera™ Test **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Incidence of the composite endpoint defined as the first occurrence of treated rejection with graft dysfunction\*, treated rejection without graft dysfunction, graft dysfunction, retransplantation, and/or death. Clinical endpoints are defined as follows: 1. Rejection: ISHLT ACR Grade ≥ 2R or AMR Grade ≥ pAMR1 2. Graft dysfunction: LVEF decline ≥ 10% from baseline and \< 50% absolute LVEF by echocardiography 3. Retransplantation: being listed for re-transplant or being re-transplanted * Treated rejection with graft dysfunction and/or graft dysfunction requiring treatment with pulse dose steroids, monoclonal antibodies, plasmapheresis, and/or intravenous immunoglobulin (IVIg). **Measure:** Primary Clinical Endpoint **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age 18 years or older at the time of signing informed consent. 2. Undergoing transplant evaluation or currently on the heart transplant waiting list and expected to receive a heart transplant. 3. Able to read, understand and provide written informed consent. If the patient is unable to sign informed consent, a legally authorized representative (LAR) can consent on behalf of the patient. 4. Able and willing to comply with the study visit schedule, study procedures and study requirements. Exclusion Criteria: 1. Concurrent multiple solid organ or tissue transplants. 2. Prior history of any organ or cellular transplantation. 3. Planned use of other commercially available or investigational cfDNA or gene expression profile assays for rejection surveillance. 4. Pregnant. 5. Hemodynamically unstable or other serious medical condition that may adversely affect the subject's ability to participate in the study. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ACES@natera.com **Name:** Kiara Stoddard **Phone:** (650) 249-9090 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Natera, Inc. **Name:** Michael Olymbios, MD **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** University of Utah **Name:** Josef Stehlik, MD **Role:** STUDY_CHAIR **Official 3:** **Affiliation:** Inova Schar Heart and Vascular **Name:** Palak Shah, MD **Role:** STUDY_CHAIR ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414590 **Brief Title:** Neoadjuvant Tebentafusp for Uveal Melanoma **Official Title:** Neoadjuvant Tebentafusp in Patients With Locally Advanced, Unresectable Primary Uveal Melanoma #### Organization Study ID Info **ID:** iRISID-2023-2369 #### Organization **Class:** OTHER **Full Name:** Thomas Jefferson University ### Status Module #### Completion Date **Date:** 2028-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-04 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-03-25 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Thomas Jefferson University #### 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 phase II trial tests how well tebentafusp works to shrink tumors prior to primary treatment with surgery or radiation in patients with uveal (eye) melanoma that has spread to nearby tissue or lymph nodes (locally advanced) or that cannot be removed by surgery (unresectable). Tebentafusp is a drug that binds to melanoma tumor cells as well as immune cells called T-cells. This binding causes an immune response against the melanoma cells, which leads to tumor cell death. Tebentafusp has been approved for the treatment of locally advanced and unresectable uveal melanoma. Giving tebentafusp before primary treatment with surgery or radiation may help shrink the tumor, prevent the disease from spreading, or reduce the likelihood that patients will require total eye removal (called enucleation). **Detailed Description:** PRIMARY OBJECTIVE: I. To assess the efficacy of neoadjuvant tebentafusp in patients with large surgically unresectable (other than complete enucleation of eye) primary uveal melanoma. SECONDARY OBJECTIVES: I. To assess the local (eye) and systemic toxicity with tebentafusp treatment. II. To investigate the usefulness of circulating tumor-derived deoxyribonucleic acid (DNA) (ctDNA) as a biomarker for response. EXPLORATORY OBJECTIVES: I. To assess sight preservation. II. To assess the change in radiation dose to the fovea. OUTLINE: Patients receive tebentafusp intravenously (IV) over 15-20 minutes on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Within 28 days of their last dose of tebentafusp, patients undergo standard of care (SOC) primary eye treatment (plaque radiotherapy or eye enucleation), as decided by their treating physician. Patients also undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) at screening, ophthalmic ultrasound, optical coherence tomography (OCT), wide-angle fundus imaging, OCT angiography (OCTA), fluorescein angiography, orbit magnetic resonance imaging (MRI), and collection of blood samples throughout the trial, undergo biopsy and collection of aqueous humour samples at screening and on study, and undergo abdominal MRI and chest and pelvis computed tomography (CT) at screening and during follow up. After completion of primary eye treatment, patients are followed up at 3 months and then every 3 months for up to 5 years. ### Conditions Module **Conditions:** - Locally Advanced Unresectable Uveal Melanoma ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 19 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Tebentafusp administration: 20mcg on Day 1, 30mcg on Day 8, 68 mcg on Day 15, and weekly doses of 68 mcg thereafter. Eye evaluations including clinical examination, ophthalmic ultrasound, optical coherence tomography, and wide-angle fundus imaging will be performed at baseline, Cycle 1 day 1, Cycle 1 day 8, Cycle 2 day 1, prior to definitive treatment for primary uveal melanoma (post-Tebentafusp), and at post-eye treatment evaluation at 3 months. Additionally optical coherence tomography angiography, autofluorescence, fluorescein angiography and MRI orbit will be performed at baseline, post-tebentafusp, and at post-eye treatment evaluation. Blood circulating tumor-derived DNA will be performed at baseline, Cycle 2 day 1, post-Tebentafusp, and at post-eye treatment evaluation at 3 months. Primary eye tumor biopsy (collected by fine-needle aspiration) and aqueous circulating tumor-derived DNA will be performed at baseline and post-Tebentafusp. **Intervention Names:** - Drug: Tebentafusp-Tebn **Label:** Neoadjuvant Tebentafusp in Patients Locally Advanced, Unresectable Primary Uveal Melanoma **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Neoadjuvant Tebentafusp in Patients Locally Advanced, Unresectable Primary Uveal Melanoma **Description:** Tebentafusp will be administered as follows: 20mcg on Day 1, 30mcg on Day 8, 68 mcg on Day 15, and weekly doses of 68 mcg thereafter. **Name:** Tebentafusp-Tebn **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Ophthalmological examination for assessment of disease: this will be performed within 48 hours prior to Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 2 Day 1. Additional ophthalmological examinations may be performed if clinically indicated. All ophthalmological examinations must be performed and interpreted by a qualified ocular oncologist. Examination will include clinical eye examination, ophthalmic ultrasound, wide-angle fundus imaging, and optical coherence tomography **Measure:** Assessment of visual acuity loss at baseline (prior to Tebentafusp treatment), prior to plaque brachytherapy, and 3) following plaque brachytherapy (after resolution of any radiation side effects/edema). **Time Frame:** 22 months **Description:** Change in modeled radiation dose at critical eye structures before and after neoadjuvant Tebentafusp therapy **Measure:** Change in radiation dose to the fovea. **Time Frame:** 22 months **Description:** Assessment of proportion of patients who had planned enucleation prior to therapy, but following Tebentafusp treatment were suitable for plaque brachytherapy. **Measure:** Enucleation vs plaque brachytherapy post-treatment **Time Frame:** 22 months #### Primary Outcomes **Description:** Regression is defined as ≥ 20% reduction in tumor volume. All estimates of rates will be presented with corresponding 95% exact confidence intervals. For regression rate, the method of Atkinson and Brown will be used to allow for the two-stage design. **Measure:** Regression of primary uveal melanoma after Tebentafusp treatment in 20% of treated patients. **Time Frame:** 22 months #### Secondary Outcomes **Description:** Will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (AE) version 5.0. All estimates of rates will be presented with corresponding 95% exact confidence intervals. AEs will be reported for each dose level and presented as tables of frequency of AEs by body system and by worse severity grade observed. AE term start and end date, severity, seriousness, outcome, action taken regarding study drugs and relationship to each study drug will also be reported. The summary tables will also discuss AEs leading to death and AEs leading to study drug(s) discontinuation. Tables should indicate related and unrelated events. Laboratory data will be presented by dose level at each observation time. Values outside normal limits will be identified and summarized by frequency distribution. **Measure:** Incidence of adverse events (AEs) **Time Frame:** Up to 5 years **Description:** Plasma of patients will be collected for all patients at baseline (within 28 days of first dose), cycle 2 day 1, post-tebentafusp (within 14 days of last dose), and at the 3 month post-treatment evaluation. ctDNA response will be measured (defined as ≥0.3 log reduction) in ctDNA-evaluable patients as measured using Signatera assay and correlated with eye tumor regression. **Measure:** Detection of plasma circulating tumor-derived deoxyribonucleic acid (ctDNA) and correlation of antitumor response **Time Frame:** 22 months **Description:** Aqueous humor of patients will be collected at baseline and post-tebentafusp; if no ctDNA is detectable in the aqueous humor after 5 patients we will stop collecting aqueous ctDNA for the rest of the patients. ctDNA response will be measured (defined as ≥0.3 log reduction) in ctDNA-evaluable patients as measured using Signatera assay and correlated with eye tumor regression. **Measure:** Detection of aqueous humor ctDNA and correlation of antitumor response **Time Frame:** 22 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Male or female patient age ≥ 18 years of age at the time of informed consent. 2. Ability to provide and understand written informed consent prior to any study procedures. 3. Willingness to undergo tumor biopsies at baseline and post-Tebentafusp treatment. 4. Treatment naïve primary uveal melanoma with T3 or T4 category tumor size that are surgically unresectable (other than complete enucleation of eye). 5. No surgical indication to completely remove the tumor without enucleation. 6. Clinically or cytologically confirmed primary uveal melanoma. 7. Participants must be HLA-A\*02:01 positive. 8. Predicted life expectancy of at least 12 weeks as estimated by investigator 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening. 10. All other relevant medical conditions must be well-managed and stable, in the opinion of the investigator, for at least 28 days prior to first administration of study drug. 11. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. Exclusion Criteria: 1. Symptomatic uveal melanoma that requires immediate ophthalmological intervention such as enucleation. 2. Evidence of metastatic disease. 3. Previous treatment with Tebentafusp. 4. Patients with any out-of-range laboratory values defined as: * Serum creatinine \> 1.5 x upper limit of normal (ULN) and/or creatinine clearance (calculated using Cockcroft-Gault Formula, or measured) \< 50 mL/minute * Albumin \< 3.0 g/dl * Total bilirubin \>1.5 mg/dL (or 1.3 x ULN). Patients with hyperbilirubinemia clinically consistent with an inherited disorder of bilirubin metabolism (e.g., Gilbert syndrome) will be eligible at the discretion of the treating physician and/or the principal investigator. * Alanine aminotransferase \> 1.5 x ULN * Aspartate aminotransferase \> 1.5 x ULN * Absolute neutrophil count \< 1.0 x 109 /L * Absolute lymphocyte count \< 0.5 x 109 /L * Platelet count \< 100 x 109 /L * Hemoglobin \< 9.0 g/dL * Uncorrectable abnormal potassium, magnesium, corrected calcium or phosphate abnormality of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0) \> grade 1 * Morning cortisol \< lower limit of normal (unless the patient has asymptomatic adrenal insufficiency and is receiving stable replacement doses) 5. History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies. 6. Clinically significant cardiac disease or impaired cardiac function, including any of the following: * Left Ventricular Ejection Fraction \<50% * Clinically significant and/or uncontrolled heart disease such as congestive heart failure (New York Heart Association grade ≥ 2), uncontrolled hypertension, or clinically significant arrhythmia uncontrolled with medical treatment * QTcF \> 470 msec on screening electrocardiogram (ECG) or congenital long QT syndrome * Acute myocardial infarction or unstable angina pectoris \< 6 months to Screening 7. Active infection requiring systemic antibiotic therapy. Patients requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to the first dose of study drug. 8. Participants with a history of human immunodeficiency virus (HIV) infection. NOTE: Testing is not required unless mandated by the local health authority. Participants with HIV infection may be eligible if ALL of the following are applicable: 1. Receiving an approved, stable, effective combination antiretroviral therapy regimen for \> 3 months prior to the planned first study intervention. NOTE: please review Section 5.7 and consider whether any actions should be taken to minimize potential drug-drug interactions, 2. CD4 T cell count \> 350 cells/µl, 3. CD4 T cell nadir (lowest historical count) \> 200 cells/µl, and 4. Viral load confirmed as \< 50 copies/mL during Screening. 9. Participants with a known history of chronic viral infections as indicated below. NOTE: Testing for hepatitis B virus (HBV) or hepatitis C virus (HCV) is not required unless mandated by the local health authority. 1. Known HBV infection defined as hepatitis B surface antigen reactive. NOTE: Participants with HBV infection on stable anti-viral therapy for \> 4 weeks prior to the planned first study intervention and viral load confirmed as undetectable during Screening may be eligible. 2. Known active HCV infection defined as detectable HCV RNA (qualitative) infection. NOTE: History of HCV is not exclusionary if participants have received curative treatment and viral load is confirmed as undetectable during screening. 10. Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers; any malignancy considered to be indolent and that has never required therapy; and completely resected carcinoma in situ of any type. 11. Any medical condition that would, in the investigator's or Sponsor's judgement, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Rino.Seedor@Jefferson.edu **Name:** Rino Seedor, MD **Phone:** 215-955-8874 **Role:** CONTACT #### Locations **Location 1:** **City:** Philadelphia **Country:** United States **Facility:** Sidney Kimmel Cancer Center at Thomas Jefferson University **State:** Pennsylvania **Zip:** 19107 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000018358 - Term: Neuroendocrine Tumors - ID: D000017599 - Term: Neuroectodermal Tumors - ID: D000009373 - Term: Neoplasms, Germ Cell and Embryonal - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009380 - Term: Neoplasms, Nerve Tissue - ID: D000018326 - Term: Nevi and Melanomas - ID: D000012878 - Term: Skin Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000012871 - Term: Skin Diseases - ID: D000005134 - Term: Eye Neoplasms - ID: D000005128 - Term: Eye Diseases - ID: D000014603 - Term: Uveal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC11 - Name: Eye Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11528 - Name: Melanoma - Relevance: HIGH - As Found: Melanoma - ID: M17352 - Name: Uveal Neoplasms - Relevance: HIGH - As Found: Uveal Melanoma - ID: M20495 - Name: Neuroendocrine Tumors - Relevance: LOW - As Found: Unknown - ID: M19845 - Name: Neuroectodermal Tumors - Relevance: LOW - As Found: Unknown - ID: M20388 - Name: Neuroectodermal Tumors, Primitive - Relevance: LOW - As Found: Unknown - ID: M12318 - Name: Neoplasms, Germ Cell and Embryonal - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M12325 - Name: Neoplasms, Nerve Tissue - Relevance: LOW - As Found: Unknown - ID: M12448 - Name: Nevus, Pigmented - Relevance: LOW - As Found: Unknown - ID: M12446 - Name: Nevus - Relevance: LOW - As Found: Unknown - ID: M20470 - Name: Nevi and Melanomas - Relevance: LOW - As Found: Unknown - ID: M15681 - Name: Skin Neoplasms - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M8277 - Name: Eye Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: M17351 - Name: Uveal Diseases - Relevance: LOW - As Found: Unknown - ID: T3099 - Name: Intraocular Melanoma - Relevance: HIGH - As Found: Uveal Melanoma - ID: T4091 - Name: Neuroendocrine Tumor - Relevance: LOW - As Found: Unknown - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown - ID: T5824 - Name: Uveal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008545 - Term: Melanoma - ID: D000014604 - Term: Uveal Neoplasms ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414577 **Brief Title:** Irinotecan Liposomes in Combination With Nituzumab for the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma After Failure of First-Line or Higher Immunotherapy **Official Title:** A Single-Arm Phase II Clinical Study of Irinotecan Liposomes in Combination With Nituzumab for the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma After Failure of First-Line or Higher Immunotherapy #### Organization Study ID Info **ID:** B2024-110-01 #### Organization **Class:** OTHER **Full Name:** Sun Yat-sen University ### Status Module #### Completion Date **Date:** 2026-05-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-04-29 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** XIANG YANQUN #### Responsible Party **Investigator Affiliation:** Sun Yat-sen University **Investigator Full Name:** XIANG YANQUN **Investigator Title:** Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Nasopharyngeal cancer is a malignant tumor that arises from the cells of the nasopharyngeal epithelium, with its occurrence spread across different regions worldwide. Recent data from China in 2015 revealed approximately 6.0 million new cases of nasopharyngeal cancer, leading to approximately 34,000 deaths. When choosing a chemotherapy regimen for patients with metastatic nasopharyngeal cancer, the gemcitabine and cisplatin combination (GP) is typically recommended as the initial treatment. However, it is common for patients to experience disease progression after receiving first-line chemotherapy, highlighting the importance of a well-defined second-line treatment plan. Recent clinical studies have indicated that combining nituzumab with radiotherapy can enhance treatment efficacy with minimal side effects, providing promising results for advanced nasopharyngeal cancer patients. Additionally, the use of irinotecan liposome injection has proved beneficial in modifying the drug's pharmacokinetics, resulting in improved drug delivery to the tumor site while reducing toxicity in healthy tissues. This study aims to explore the effectiveness and safety of combining irinotecan liposome with nituzumab treatment for recurrent metastatic nasopharyngeal carcinoma that has not responded to initial immunotherapy. Participants selected for this clinical trial will receive a treatment regimen consisting of liposomal irinotecan administered intravenously at a dose of 70 mg/m2 on day 1, along with nituzumab given at a dose of 400 mg via intravenous injection on the same day. This treatment cycle will be repeated every two weeks for a maximum of eight cycles, or until disease progression, intolerable side effects, or other criteria necessitating discontinuation of treatment as determined by the investigator. By evaluating the efficacy and safety of this combined regimen, investigators aim to establish a novel therapeutic approach for managing advanced nasopharyngeal carcinoma in the context of current immunotherapy advancements. ### Conditions Module **Conditions:** - Nasopharyngeal Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** liposomal irinotecan administered intravenously at a dose of 70 mg/m2 on day 1, along with nituzumab given at a dose of 400 mg via intravenous injection on the same day. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 37 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Irinotecan Liposomal combined With Nituzumab **Label:** Irinotecan Liposomes combined With Nituzumab **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Irinotecan Liposomes combined With Nituzumab **Description:** Irinotecan liposomal: 70mg/m2, ivgtt, d1; Nituzumab: 400 mg, igvtt, d1 One treatment cycle every two weeks for up to 8 cycles, or until disease progression, intolerable toxicity, death, and investigator judgment of no further benefit **Name:** Irinotecan Liposomal combined With Nituzumab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Objective remission rate (ORR) **Time Frame:** up to 2 years #### Secondary Outcomes **Measure:** one-year overall survival(OS) rate **Time Frame:** up to 2 years **Measure:** one-year progression-free survival(PFS) rate **Time Frame:** up to 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 1. subjects volunteered to participate in the study and signed an informed consent form (ICF); 2. age ≥ 18 years; and 3. previous histopathological diagnosis of non-keratinizing carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., WHO classification type II or III); and 4. positive EGFR test; 5. patients with recurrent/metastatic nasopharyngeal cancer who have received prior treatment with first-line or higher standard regimens containing PD-1/PD-L1 inhibitors; 6. at least 1 evaluable lesion at baseline according to RECIST 1.1 criteria; the area must not have received prior radiotherapy or there must be evidence of significant progression of the lesion after completion of radiotherapy; 7. ECOG score 0 to 1; expected survival ≥ 3 months 8. No serious cardiac, pulmonary, hepatic, renal or other vital organ dysfunction; normal hepatic and renal function: AST, ALT \<2.5 times the upper limit of normal, total bilirubin \<1.5 times the upper limit of normal; serum creatinine ≤1.5 × the upper limit of normal and creatinine clearance ≥ 30 mL/min; adequate bone marrow function: peripheral blood leukocytes \>4.0 × 109/L, neutrophils \>1.0 × 109/L, hemoglobin \>90%. 109/L, hemoglobin \> 90 g/L, platelets \> 100 × 109/L; Exclusion Criteria: * 1. history of hypersensitivity to monoclonal antibodies; hypersensitivity to liposomal irinotecan; 2. use of a strong inducer of CYP3A4 within 2 weeks or a strong inhibitor of CYP3A4 or a strong inhibitor of UGT1A1 within 1 week prior to the first administration of the trial drug; 3. expected survival time \< 3 months; 4. active hepatitis B (HbsAg or HBcAb positive and HBV DNA ≥ 2000 IU/mL), active hepatitis C (HCV antibody positive and HCVRNA above the lower limit of the study center's assay); if the patient has normal liver function and is taking concomitant antiviral medication, eligibility for enrollment will be determined by the investigator; 5. patients who are HIV antibody positive; and 6. active bacterial, fungal, viral, or interstitial pneumonia requiring systemic therapy within 1 week prior to the first dose of study drug; and 7. have received antineoplastic therapy such as chemotherapy, small molecule inhibitors, immunotherapy (e.g., interleukin, interferon, or thymosin) within 4 weeks or 5 half-lives, whichever is shorter, but at least 2 weeks prior to the first dose of study drug; 8. treatment with a proprietary Chinese medicine with antitumor activity within 14 days prior to administration; treatment with another clinically investigational drug within 4 weeks prior to the first dose; 9. has undergone major surgery within 3 months prior to the first dose, or plans to undergo major surgery during the study period 10. has had a serious embolic event, e.g., cerebrovascular accident (including transient ischemic attack), pulmonary embolism, within 6 months prior to screening; 11. active malignancy within 2 years prior to the first study drug administration, with the exception of nasopharyngeal carcinoma, which is being studied in this trial, and any locally curable tumors that have undergone radical therapy (e.g., resected basal or squamous cell skin cancer, superficial bladder cardiac abnormalities including: carcinoma of the bladder, carcinoma of the cervix, or breast carcinoma in situ) 12. severe cardiovascular disease within 6 months prior to enrollment, including but not limited to the following: * Acute myocardial infarction, unstable angina, coronary angioplasty or stenting, deep vein thrombosis, stroke; ② New York Heart Association class III or IV congestive heart failure or left ventricular ejection fraction (LVEF) \<50%; ③ Abnormal electrocardiograms (ECGs) of clinical significance at the time of screening, as assessed by the investigator; 13. women who are pregnant or breastfeeding; 14. any serious and/or uncontrollable medical condition, as determined by the investigator, other medical conditions that may interfere with the patient's participation in this study (including, but not limited to, uncontrolled diabetes mellitus, renal disease requiring dialysis, severe liver disease, life-threatening autoimmune and bleeding disorders, substance abuse, neurological disorders, etc.);; and 15. other conditions judged by the investigator to be unsuitable for participation **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Guangzhou **Country:** China **Facility:** SunYat-senU **State:** Guangdong **Zip:** 510060 ### IPD Sharing Statement Module **IPD Sharing:** NO ## 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: D000010610 - Term: Pharyngeal Neoplasms - ID: D000010039 - Term: Otorhinolaryngologic Neoplasms - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009302 - Term: Nasopharyngeal Diseases - ID: D000010608 - Term: Pharyngeal Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000010038 - Term: Otorhinolaryngologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M1730 - Name: Nasopharyngeal Carcinoma - Relevance: HIGH - As Found: Nasopharyngeal Carcinoma - ID: M12254 - Name: Nasopharyngeal Neoplasms - Relevance: HIGH - As Found: Nasopharyngeal Cancer - 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: M13517 - Name: Pharyngeal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12962 - Name: Otorhinolaryngologic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12253 - Name: Nasopharyngeal Diseases - Relevance: LOW - As Found: Unknown - ID: M13515 - Name: Pharyngeal Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M12961 - Name: Otorhinolaryngologic Diseases - Relevance: LOW - As Found: Unknown - ID: T4047 - Name: Nasopharyngeal Carcinoma - Relevance: HIGH - As Found: Nasopharyngeal Carcinoma ### Condition Browse Module - Meshes - ID: D000077274 - Term: Nasopharyngeal Carcinoma - ID: D000009303 - Term: Nasopharyngeal Neoplasms ### Intervention Browse Module - Ancestors - ID: D000059004 - Term: Topoisomerase I Inhibitors - ID: D000059003 - Term: Topoisomerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1671 - Name: Irinotecan - Relevance: HIGH - As Found: Infection - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: M29349 - Name: Topoisomerase I Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077146 - Term: Irinotecan ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414564 **Brief Title:** Effects of AHCL Insulin Pump on Glycemic Control and Psychosocial Outcomes in Pediatric Patients With Type 1 Diabetes **Official Title:** Effects of Advanced Hybrid Closed-loop System on Glycemic Control and Psychosocial Outcomes in Pediatric Patients With Type 1 Diabetes #### Organization Study ID Info **ID:** 23081591461 #### Organization **Class:** OTHER **Full Name:** Seoul National University Hospital ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-01-30 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Medtronic #### Lead Sponsor **Class:** OTHER **Name:** Seoul National University Hospital #### Responsible Party **Investigator Affiliation:** Seoul National University Hospital **Investigator Full Name:** Lee Young Ah **Investigator Title:** Associate professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Prospective, non-randomized, single-arm clinical trial to investigate the effects of advanced hybrid close-loop (AHCL) system insulin pump in pediatric patients with type 1 diabetes **Detailed Description:** This trial consists of baseline phase of 3 weeks sustaining the treatment previously maintained by the patient, followed by study phase of 12 weeks of AHCL system application. ### Conditions Module **Conditions:** - Type 1 Diabetes ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SEQUENTIAL ##### 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:** insulin infusion using AHCL system insulin pump (Medtronic 780G) with continous glucose monitoring (guardian G4) **Intervention Names:** - Device: Medtronic 780G insulin pump **Label:** AHCL system application **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - AHCL system application **Description:** Subjects on insulin infusion by 780G AHCL system **Name:** Medtronic 780G insulin pump **Type:** DEVICE ### Outcomes Module #### Other Outcomes **Description:** Measured in time, derived from Fitbit data **Measure:** Sleep enter and end time **Time Frame:** baseline (3 weeks) and intervention (12 weeks) period **Description:** Measured in hours and minutes, derived from Fitbit data **Measure:** Sleep duration **Time Frame:** baseline (3 weeks) and intervention (12 weeks) period **Description:** Derived from Fitbit data **Measure:** Sleep efficiency **Time Frame:** baseline (3 weeks) and intervention (12 weeks) period **Description:** Derived from Fitbit data **Measure:** Wake after sleep onset **Time Frame:** baseline (3 weeks) and intervention (12 weeks) period #### Primary Outcomes **Description:** glucose level between 70-180 mg/dL derived from continuous glucose monitoring **Measure:** Time In Range (TIR) **Time Frame:** baseline (3 weeks) and intervention (12 weeks) period #### Secondary Outcomes **Description:** glucose level \>180 mg/dL derived from continuous glucose monitoring **Measure:** Time Above Range (TAR) **Time Frame:** baseline (3 weeks) and intervention (12 weeks) period **Description:** glucose level \<70 mg/dL derived from continuous glucose monitoring **Measure:** Time Below Range (TBR) **Time Frame:** baseline (3 weeks) and intervention (12 weeks) period **Description:** mean sensor glucose level derived from continuous glucose monitoring **Measure:** mean sensor glucose **Time Frame:** baseline (3 weeks) and intervention (12 weeks) period **Description:** Standard deviation \* 100/ mean (derived from continuous glucose monitoring) **Measure:** Coefficient of variation (CV) **Time Frame:** baseline (3 weeks) and intervention (12 weeks) period **Description:** Estimated HbA1c levels derived from continuous glucose monitoring **Measure:** Glucose management indicator (GMI) **Time Frame:** baseline (3 weeks) and intervention (12 weeks) period **Description:** Glycated hemoglobin level **Measure:** HbA1c **Time Frame:** before and at the end of intervention, which in average lasts 12 weeks **Description:** Glycated albumin level **Measure:** Glycated albumin **Time Frame:** before and at the end of intervention, which in average lasts 12 weeks **Description:** Measured by PedsQL (Pediatric Quality of Life InventoryTM) Generic Core, Module 4.0 (values: 0\~100, higher score means better outcome) **Measure:** Quality of life measurements (general) of patients and parents **Time Frame:** baseline (3 weeks) and intervention (12 weeks) period **Description:** Measured by PedsQL (Pediatric Quality of Life InventoryTM) Diabetes Specific, Module 3.0 (values: 0\~100, higher score means better outcome) **Measure:** Quality of life measurements (diabetes-specific) of patients and parents **Time Frame:** baseline (3 weeks) and intervention (12 weeks) period **Description:** Measured by Korean Children's Depression Inventory, 2nd Edition (values: 0\~100, higher score means worse outcome) or Korean Beck Depression Inventory, 2nd Edition (higher score means worse outcome) **Measure:** Children's Depression Inventory(CDI) (age 7-17) or Beck Depression Inventory (BDI) (age 18-19) of patients **Time Frame:** baseline (3 weeks) and intervention (12 weeks) period ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. The subject is age 7-19 2. The subject with one or more of the below * serum c-peptide ≤ 0.6 ng/mL at diagnosis * positive glutamic acid decarboxylase (GAD) antibody * positive islet cell antibody * positive anti-Insulin antibody * positive anti-islet Antigen-2 (IA-2) antibody 3. The subject was diagnosed with type 1 diabetes ≥ 1 year 4. The subject has been continuously treated at least for 8 weeks at the start of the study, by one of the existing insulin treatment methods \[insulin multi-injection (MDII), general insulin pump (CSII), sensor-linked insulin pump (SAP), or 770G insulin pump (HCL system)\] 5. The subject has been applied with real-time continuous glucose monitoring at least for 8 weeks at the start of the study Exclusion Criteria: 1. Any systemic treatment with drugs known to interfere with glucose metabolism within 8 weeks prior to trial 2. Subjects with underlying hematologic disorders that can affect the HbA1c levels 3. Subjects with underlying medical disorders that can affect glucose metabolism 4. Subjects with a neuropsychiatric disorder such as depression or eating disorder 5. Subjects with underlying thyroid disorders and abnormal thyroid function **Maximum Age:** 19 Years **Minimum Age:** 7 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** nina337@snu.ac.kr **Name:** Young Ah Lee, MD, PhD **Phone:** 82-2-2072-2308 **Role:** CONTACT **Contact 2:** **Email:** yjlee103@snuh.org **Name:** Yun Jeong Lee, MD **Phone:** 82-2-2072-2811 **Role:** CONTACT #### Locations **Location 1:** **City:** Seoul **Contacts:** ***Contact 1:*** - **Email:** nina337@snu.ac.kr - **Name:** Young Ah Lee, MD, PhD - **Phone:** 82-2-2072-2308 - **Role:** CONTACT ***Contact 2:*** - **Email:** yjlee103@snuh.org - **Name:** Yun Jeong Lee, MD - **Phone:** 82-2-2072-2811 - **Role:** CONTACT **Country:** Korea, Republic of **Facility:** Seoul National University Hospital **Status:** RECRUITING **Zip:** 03080 #### Overall Officials **Official 1:** **Affiliation:** Seoul National University Hospital **Name:** Young Ah Lee, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes - ID: M7117 - Name: Diabetes Mellitus, Type 1 - Relevance: HIGH - As Found: Type 1 Diabetes - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003922 - Term: Diabetes Mellitus, Type 1 ### Intervention Browse Module - Ancestors - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M10365 - Name: Insulin - Relevance: HIGH - As Found: Day 1 - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: LOW - As Found: Unknown - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000007328 - Term: Insulin ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414551 **Brief Title:** Calcification on CTCA of a CTO and PCI Outcomes **Official Title:** Characteristics of Calcification in a Chronic Total Occlusion on Computed Tomography Coronary Angiogram and Percutaneous Coronary Intervention Outcomes- a Single Centre Observational Study #### Organization Study ID Info **ID:** IRAS Project ID: 333718 #### Organization **Class:** OTHER **Full Name:** Sandwell & West Birmingham Hospitals NHS Trust ### Status Module #### Completion Date **Date:** 2025-07-01 **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:** 2025-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Sandwell & West Birmingham Hospitals NHS Trust #### Responsible Party **Investigator Affiliation:** Sandwell & West Birmingham Hospitals NHS Trust **Investigator Full Name:** Vinoda Sharma **Investigator Title:** Cardiology Specialty Lead, Honorary Associate Professor, Interventional Cardiologist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** A chronic total occlusion (CTO) is present in 15-20% of patients who are referred for invasive coronary angiography. CTO Percutaneous Coronary Intervention (PCI) procedure success rates have increased over the years and can be as high as 90% when performed by high-volume CTO operators.Procedurally, excess calcification in the CTO anatomy is one factor which makes it difficult to complete the procedure or obtain ideal stent expansion. Excess calcification is best identified by Computed Tomography Coronary Angiography (CTCA) rather than invasive angiography. The investigators plan to retrospectively evaluate CTCA in patients who underwent CTO PCI and correlate calcification characteristics with CTO PCI outcomes and tools utilised for calcium modification. **Detailed Description:** Cohort: All coronary CTO patients who underwent a PCI attempt and also underwent CTCA at our centre in the last 5 years. Method of identifying and consenting patients: Screening of our local database to identify suitable patients who fulfil the inclusion/exclusion criteria. These patients will be telephoned and the consent form and participant information sheet will be maile dot them along with a self addressed stamped envelope.On receipt of the consent form, we will countersign it and return a copy to the patient. Consented patients' images and reports of the CTCA and CTO PCI will be reviewed. Characteristics of calcification in the CTO on the CTCA will be evaluated including site, density and quantity of calcification. This will be correlated with CTO PCI outcomes of success and failure. Also this will be correlated with use of calcium modification tools for the CTO PCI. * Baseline and demographic as well as procedural data will be compared with CTO PCI outcomes and presence/characteristics of calcification. * Characteristics of calcification in the CTO assessed will include: site, density in Hounsfield units and quantity. * Site of calcification (proximal, body or distal) will be correlated with the CTO PCI outcome by chi square analysis. * Calcium density (in Hounsfield Units) on the CTCA will be correlated with successful versus failed CTO PCI by ROC curve analysis. * Quantity of calcification will be assessed as a percentage of the cross section of the CTO body (as \<50%, 50-75% and 75-100%) and correlated with CTO PCI success by contingency analysis. * Use of calcium modification tools will be correlated with CTO PCI outcome (success or failure) and density of calcification on CTCA (ROC curve and ANOVA). * Categorical variables will be compared by the chi square or Fisher's test and continuous variables will be compared by the Mann Whitney U test. In addition, based on CTO PCI outcome of success or failure, patients will be compared for demographics and procedural variables. * Categorical variables will be presented as percentage and compared with the chi square or Fisher's test * Continuous variables will be presented as median (range) and compared with student's t-test or Mann Whitney test. ### Conditions Module **Conditions:** - Chronic Total Occlusion of Coronary Artery - Calcification - Computed Tomography Angiography **Keywords:** - CTCA - CTO ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with coronary CTO who underwent attempt at PCI and also underwent a CTCA **Label:** CTO patients who underwent attempted PCI ### Outcomes Module #### Primary Outcomes **Description:** Success or failure **Measure:** Correlation of characteristics of calcification with CTO PCI outcome (success or failure) **Time Frame:** up to 24 hours #### Secondary Outcomes **Description:** Percentage of patients in whom any calcium modifying tool was used and the corelation of this with the severity of calcification. **Measure:** Utility of calcium modifying tools for the CTO PCI procedure and correlation with severity of calcification **Time Frame:** up to 24 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients meeting all the below criteria will be included * ≥18 years * Previous CTO PCI attempt in the last 5 years * Undergone CTCA either pre or post CTO PCI * Adequate CTCA images for analysis Exclusion Criteria: * Patients meeting any of the following criteria will be excluded * \<18 years of age * Did not undergo CTCA * Inadequate/degraded CTCA images **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with coronary CTO who underwent attempt at PCI and also underwent CTCA ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** vinodasharma@nhs.net **Name:** Vinoda Sharma, FRCP **Phone:** +44(0)1215075841 **Role:** CONTACT **Contact 2:** **Email:** swbh.randd.generic@nhs.net **Name:** Kelly Hard **Phone:** +44(0)121 507 4811 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Sandwell & West Birmingham Hospitals NHS Trust **Name:** Vinoda Sharma, FRCP **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Tajti P, Brilakis ES. Chronic Total Occlusion Percutaneous Coronary Intervention: Evidence and Controversies. J Am Heart Assoc. 2018 Jan 12;7(2):e006732. doi: 10.1161/JAHA.117.006732. No abstract available. **PMID:** 29330258 **Citation:** Patel VG, Brayton KM, Tamayo A, Mogabgab O, Michael TT, Lo N, Alomar M, Shorrock D, Cipher D, Abdullah S, Banerjee S, Brilakis ES. Angiographic success and procedural complications in patients undergoing percutaneous coronary chronic total occlusion interventions: a weighted meta-analysis of 18,061 patients from 65 studies. JACC Cardiovasc Interv. 2013 Feb;6(2):128-36. doi: 10.1016/j.jcin.2012.10.011. Epub 2013 Jan 23. **PMID:** 23352817 **Citation:** Sharma V, Jadhav ST, Harcombe AA, Kelly PA, Mozid A, Bagnall A, Richardson J, Egred M, McEntegart M, Shaukat A, Oldroyd K, Vishwanathan G, Rana O, Talwar S, McPherson M, Strange JW, Hanratty CG, Walsh SJ, Spratt JC, Smith WH. Impact of proctoring on success rates for percutaneous revascularisation of coronary chronic total occlusions. Open Heart. 2015 Mar 28;2(1):e000228. doi: 10.1136/openhrt-2014-000228. eCollection 2015. **PMID:** 25852949 **Citation:** Simon W. The Consistent CTO Study. 2018. **Citation:** Gada H, Whitlow PL, Marwick TH. Establishing the cost-effectiveness of percutaneous coronary intervention for chronic total occlusion in stable angina: a decision-analytic model. Heart. 2012 Dec;98(24):1790-7. doi: 10.1136/heartjnl-2012-302581. Epub 2012 Oct 4. **PMID:** 23038791 **Citation:** Grantham JA, Jones PG, Cannon L, Spertus JA. Quantifying the early health status benefits of successful chronic total occlusion recanalization: Results from the FlowCardia's Approach to Chronic Total Occlusion Recanalization (FACTOR) Trial. Circ Cardiovasc Qual Outcomes. 2010 May;3(3):284-90. doi: 10.1161/CIRCOUTCOMES.108.825760. Epub 2010 Apr 13. **PMID:** 20388873 **Citation:** Olivari Z, Rubartelli P, Piscione F, Ettori F, Fontanelli A, Salemme L, Giachero C, Di Mario C, Gabrielli G, Spedicato L, Bedogni F; TOAST-GISE Investigators. Immediate results and one-year clinical outcome after percutaneous coronary interventions in chronic total occlusions: data from a multicenter, prospective, observational study (TOAST-GISE). J Am Coll Cardiol. 2003 May 21;41(10):1672-8. doi: 10.1016/s0735-1097(03)00312-7. **PMID:** 12767645 **Citation:** Werner GS, Martin-Yuste V, Hildick-Smith D, Boudou N, Sianos G, Gelev V, Rumoroso JR, Erglis A, Christiansen EH, Escaned J, di Mario C, Hovasse T, Teruel L, Bufe A, Lauer B, Bogaerts K, Goicolea J, Spratt JC, Gershlick AH, Galassi AR, Louvard Y; EUROCTO trial investigators. A randomized multicentre trial to compare revascularization with optimal medical therapy for the treatment of chronic total coronary occlusions. Eur Heart J. 2018 Jul 7;39(26):2484-2493. doi: 10.1093/eurheartj/ehy220. **PMID:** 29722796 **Citation:** Mashayekhi KA, Pyxaras SA, Werner GS, Galassi AR, Garbo R, Boudou N, Leibundgut G, Avran A, Bryniarski L, Bufe A, Sianos G, Di Mario C. Contemporary issues of percutaneous coronary intervention in heavily calcified chronic total occlusions: an expert review from the European CTO Club. EuroIntervention. 2023 Jun 5;19(2):e113-e122. doi: 10.4244/EIJ-D-22-01096. **PMID:** 36971414 **Citation:** Morino Y, Abe M, Morimoto T, Kimura T, Hayashi Y, Muramatsu T, Ochiai M, Noguchi Y, Kato K, Shibata Y, Hiasa Y, Doi O, Yamashita T, Hinohara T, Tanaka H, Mitsudo K; J-CTO Registry Investigators. Predicting successful guidewire crossing through chronic total occlusion of native coronary lesions within 30 minutes: the J-CTO (Multicenter CTO Registry in Japan) score as a difficulty grading and time assessment tool. JACC Cardiovasc Interv. 2011 Feb;4(2):213-21. doi: 10.1016/j.jcin.2010.09.024. **PMID:** 21349461 **Citation:** Christopoulos G, Kandzari DE, Yeh RW, Jaffer FA, Karmpaliotis D, Wyman MR, Alaswad K, Lombardi W, Grantham JA, Moses J, Christakopoulos G, Tarar MNJ, Rangan BV, Lembo N, Garcia S, Cipher D, Thompson CA, Banerjee S, Brilakis ES. Development and Validation of a Novel Scoring System for Predicting Technical Success of Chronic Total Occlusion Percutaneous Coronary Interventions: The PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) Score. JACC Cardiovasc Interv. 2016 Jan 11;9(1):1-9. doi: 10.1016/j.jcin.2015.09.022. **PMID:** 26762904 **Citation:** Maeremans J, Spratt JC, Knaapen P, Walsh S, Agostoni P, Wilson W, Avran A, Faurie B, Bressollette E, Kayaert P, Bagnall AJ, Smith D, McEntegart MB, Smith WHT, Kelly P, Irving J, Smith EJ, Strange JW, Dens J. Towards a contemporary, comprehensive scoring system for determining technical outcomes of hybrid percutaneous chronic total occlusion treatment: The RECHARGE score. Catheter Cardiovasc Interv. 2018 Feb 1;91(2):192-202. doi: 10.1002/ccd.27092. Epub 2017 May 4. **PMID:** 28471074 **Citation:** Szijgyarto Z, Rampat R, Werner GS, Ho C, Reifart N, Lefevre T, Louvard Y, Avran A, Kambis M, Buettner HJ, Di Mario C, Gershlick A, Escaned J, Sianos G, Galassi A, Garbo R, Goktekin O, Meyer-Gessner M, Lauer B, Elhadad S, Bufe A, Boudou N, Sievert H, Martin-Yuste V, Thuesen L, Erglis A, Christiansen E, Spratt J, Bryniarski L, Clayton T, Hildick-Smith D. Derivation and Validation of a Chronic Total Coronary Occlusion Intervention Procedural Success Score From the 20,000-Patient EuroCTO Registry: The EuroCTO (CASTLE) Score. JACC Cardiovasc Interv. 2019 Feb 25;12(4):335-342. doi: 10.1016/j.jcin.2018.11.020. Epub 2019 Jan 30. **PMID:** 30711551 **Citation:** Opolski MP, Achenbach S, Schuhback A, Rolf A, Mollmann H, Nef H, Rixe J, Renker M, Witkowski A, Kepka C, Walther C, Schlundt C, Debski A, Jakubczyk M, Hamm CW. Coronary computed tomographic prediction rule for time-efficient guidewire crossing through chronic total occlusion: insights from the CT-RECTOR multicenter registry (Computed Tomography Registry of Chronic Total Occlusion Revascularization). JACC Cardiovasc Interv. 2015 Feb;8(2):257-267. doi: 10.1016/j.jcin.2014.07.031. **PMID:** 25700748 **Citation:** Panuccio G, Skurk C, Landmesser U, Abdelwahed YS. Double "full moon" CTO plaque detected by computed tomography could predict high-grade debulking techniques: A case-report. Clin Case Rep. 2023 May 18;11(5):e7325. doi: 10.1002/ccr3.7325. eCollection 2023 May. **PMID:** 37215968 **Citation:** Improvement N. 2019/20 National Tariff Payment System. In: system Ntp, editor. 2019. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002128 - Term: Calcium Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5377 - Name: Calcinosis - Relevance: HIGH - As Found: Calcification - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M5391 - Name: Calcium Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002114 - Term: Calcinosis ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414538 **Brief Title:** The Effect of Digital Mind Map and Midwifery Students **Official Title:** The Effect Of Digital Mind Map Technique On Learning In Midwifery Students #### Organization Study ID Info **ID:** ayla-2 #### Organization **Class:** OTHER **Full Name:** Kocaeli University ### Status Module #### Completion Date **Date:** 2025-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-08 **Type:** ESTIMATED #### Start Date **Date:** 2023-12-21 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-03-07 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ayla Ergin #### Responsible Party **Investigator Affiliation:** Kocaeli University **Investigator Full Name:** Ayla Ergin **Investigator Title:** Professor Dr. **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study was conducted to determine the effect of the digital mind map technique on the learning of midwifery students. The research will be carried out with Kocaeli University Midwifery 2nd year students. A meeting was held with students regarding extracurricular studies between 12 February and 16 February 2024, which is the beginning of the 2023-2024 academic year academic calendar of Kocaeli University. The research will be completed with 86 students in the mind map method group (n = 43) and the classical method (n = 43) group. Data will be collected through the participant information form, knowledge assessment survey on family planning, and satisfaction assessment survey of the narrative regarding the digital mind map. Three topics determined regarding family planning methods (oral contraceptives, condoms and intrauterine devices) were prepared by the researcher using the digital mind map technique. The participant information form and the knowledge evaluation survey on family planning were administered as a pre-test to the students who accepted the research at the first meeting. The mind map technique was first explained to the mind map method group. The topics were explained to the students in the mind map method group by the researcher and his advisor using the mind map technique and with materials prepared with the digital mind map technique. The classical method was explained to the classical method group by the researcher and his advisor. A posttest will be administered to both groups 1 week after the lecture. Again, 35 days after the lecture, the study will be completed by applying a permanence test to both groups and a student satisfaction survey to the experimental group. After the study, the mind map technique will be explained to all students in the classical method group who have completed the study, and the topics prepared with the digital mind map technique will be explained to the classical method group and reinforced. Statistical analysis of the data obtained as a result of the research will be carried out using the IBM Statistic 22.0 (IBM Corp., Armonk, NY, USA) program. Study data will be collected using appropriate statistical methods and the significance level will be accepted as p\<0.05. **Detailed Description:** Primary aim: The research is to determine the effect of digital mind mapping technique on learning in midwifery students. Hypotheses: H0: There is no difference between the knowledge evaluation survey average scores of students in the mind map method group and the classical method group. H1: There is a statistically significant difference between the knowledge evaluation survey score averages of students in the mind map method group and the classical method group. H2: There is no statistically significant difference between the satisfaction and motivation of students in the mind map method group and the classical method group. H3: There is a statistically significant difference between the satisfaction and motivation of students in the mind map method group and the classical method group. This study was designed as a randomized controlled experimental study. The study will be carried out at Kocaeli University Faculty of Health Sciences between February 2024 and May 2024. In order to facilitate data collection, the population of the research will consist of 86 second-year midwifery students of Kocaeli University Faculty of Health Sciences in the 2023-2024 academic year. The sample size was based on Ahmed et al.'s 2023 study in which the method of the digital mind map strategy was examined. The sample number of the study was calculated using the G\*Power 3.1.9.2 program, and the mean, standard deviation and sample number values of the knowledge test scores of the groups in the relevant article (Ahmed M.M,, Ismail E.H., Abousoliman, A, 2023) were taken into account in the effect size calculation. In the experimental group, the mean and standard deviation values of the knowledge score are 13.32±3.69 and the number of samples is 113. In the control group, the mean and standard deviation values of the knowledge score are 11.51±2.76 and the number of samples is 128. By using the mean, standard deviation and sample number values of the relevant article, the effect size was calculated as 0.560. According to the result of 95% confidence (1-α), 80% test power (1-β), d = 0.560 effect size, the minimum number of samples to be taken in each group is 16 people, a total of 32 people should be examined. In order to increase the power of analysis, n = 16 (mind map method group: 16 and classical method group: 16) will be taken for each group in the study. The students included in the research will be divided into two groups by determining which group they will belong to from the website called "Random Team Generator", which is a random number generation program. Thus, each student's number and group number will be determined and recorded. Randomization: The mother group will be determined from the random number generator site called "Random Lists". Students will be divided into two groups: mind map method and classical method group. Thus, the number of each student will be determined and recorded. Research data will be collected using the Participant Information Form, the Knowledge Evaluation Survey on Family Planning and the Satisfaction Evaluation Survey of the Explanation on Digital Mind Map. Participant Information Form: Participant information form was created as a result of literature review. This form includes questions such as the students' age, employment status, educational status of their parents, place of residence during their student years, and reasons for choosing the midwifery department. Knowledge Evaluation Survey on Family Planning: It was prepared to measure students' learning levels with a survey consisting of 30 questions as a result of literature review. The minimum value that can be obtained from the survey will be calculated as 0 and the maximum value will be calculated as 30. It will be understood that the higher the score the students receive, the better their knowledge level. Expression Satisfaction Evaluation Survey on Digital Mind Map: As a result of the literature review, a survey consisting of 25 questions was prepared to measure students' satisfaction levels with the mind map technique. There is no minimum and maximum value range. The survey has been prepared in a way that can be marked more than once and is open to interpretation.. Before the research, a pilot study will be conducted with second-year students of Sakarya University, Faculty of Health Sciences, Department of Midwifery. This pilot study will be carried out by the researcher using face-to-face interview technique between 12.02.2024-16.02.2024. Students will be asked not to share the study with other students or on social media platforms by signing a consent form and confidentiality agreement. Participants will be informed that they can leave the study at any time and the study will be completed with voluntary participants. All students participating in the research will sign a confidentiality agreement and will be ensured not to share their work with other students or on platforms such as social media. A participant information form consisting of 15 questions will be applied to each student participating in the research, and a knowledge assessment survey on family planning consisting of 30 questions will be applied to the students as a pre-test to measure their knowledge after the training. Randomization will be made among the students who agree to participate in the research, and two groups will be created: the mind map method and the classical method group. The presentation of the topics is planned between March and May 2024. The topics will be explained to the students in the mind map method group by the researcher together with his advisor, using the mind map technique. In the classical method group, the topics will be explained by the researcher together with his advisor using the classical method. One week after the lecture, a posttest knowledge assessment survey on family planning will be administered to both groups to measure the change in the students' knowledge levels. 35 days after this post-test exam, a knowledge evaluation survey on family planning will be administered to all students to measure the permanence of the subjects. In addition, a student satisfaction survey will be applied to the mind map method group to measure the satisfaction levels of the students. After the retention test is applied, the mind map technique will be explained to the students in the classical method group, and the topics prepared with the digital mind map technique will be explained to the classical method group and reinforced ### Conditions Module **Conditions:** - Education **Keywords:** - Digital mind - learning tool - midwifery - student success - motivation - family planning ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Students determined as a result of randomization will be given a pre-test before entering the "Family Planning"course planned according to the academic calendar. The planned topics will be explained using the prepared digital mind maps technique. **Intervention Names:** - Other: Digital Mind Map Technique **Label:** Digital Mind Map Technique **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The determined topics will be explained to the students in the control group using the classical method. Students' knowledge level will be measured with knowledge tests. **Intervention Names:** - Other: Classic Method Group **Label:** Classic Method Group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Digital Mind Map Technique **Description:** Students determined as a result of randomization will be given a pre-test before entering the "Family Planning" course planned according to the academic calendar. The determined topics will be explained to the students using the digital mind map technique. A post-test will be administered to the students 1 week after the end of the subject and a satisfaction survey of the digital mind map technique will be administered. Permanence test will be applied 35 days after the last test application. **Name:** Digital Mind Map Technique **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Classic Method Group **Description:** After the students in the control group are determined, a pre-test will be conducted before the subject is given training. The same knowledge test will be repeated as a final test after students have received classical course training and completed the subject. Students will be given a retention exam 35 days after the last exam. After the retention test application, the mind map method will be explained to the students in the control group and the determined topics of the course will be explained with the prepared digital mind map technique. In this way, all students participating in the study will also have access to the additional educational materials used. **Name:** Classic Method Group **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** It will be applied as a pre-test with the Knowledge Evaluation Survey on Family Planning in order to determine the students' knowledge levels. It was prepared to measure students' learning levels with a survey consisting of 30 questions. The minimum value that can be obtained from the survey will be calculated as 0 and the maximum value will be calculated as 30. It will be understood that the higher the score the students receive, the better their knowledge level. **Measure:** Knowledge Level **Time Frame:** 4 weeks **Description:** After the topics are explained, the final test of the Family Planning Knowledge Evaluation Survey will be applied to determine the students' knowledge levels. It was prepared to measure students' learning levels with a survey consisting of 30 questions. The minimum value that can be obtained from the survey will be calculated as 0 and the maximum value will be calculated as 30. It will be understood that the higher the score the students receive, the better their knowledge level. **Measure:** Knowledge Level **Time Frame:** 8 weeks **Description:** In order to evaluate the materials prepared with the digital mind map technique of the students in the experimental group, a Satisfaction Evaluation Survey of the Expression on Digital Mind Map will be conducted. It is a survey consisting of 25 questions. There is no minimum and maximum value range. The prepared survey was prepared in a way that you could mark more than once and was open to interpretation. **Measure:** Satisfaction levels of materials prepared with the digital mind map technique **Time Frame:** 2 weeks **Description:** It will be applied as a retention test of the Family Planning Knowledge Evaluation Survey to determine the students' knowledge levels. It was prepared to measure students' learning levels with a survey consisting of 30 questions. The minimum value that can be obtained from the survey will be calculated as 0 and the maximum value will be calculated as 30. It will be understood that the higher the score the students receive, the better their knowledge level. **Measure:** Knowledge Level **Time Frame:** 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Volunteering to participate in the research, * Between the ages of 18-30, * Kocaeli University Faculty of Health Sciences Midwifery 2nd year student * Students who are not absent Exclusion Criteria: * Those who want to leave the study for any reason, * Leaving questionnaires incomplete, * Students who have previously received training on family planning **Healthy Volunteers:** True **Maximum Age:** 30 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ergina@kocaeli.edu.tr **Name:** Ayla Ergin, Proff. Dr. **Phone:** +90 262 303 47 01 02 **Role:** CONTACT **Contact 2:** **Email:** ebesemagunes@gmail.com **Name:** Sema Güneş Yanık, Graduate st **Phone:** +90 545 430 88 28 **Role:** CONTACT #### Locations **Location 1:** **City:** Kocaeli **Contacts:** ***Contact 1:*** - **Email:** ergina@kocaeli.edu.tr - **Name:** Ayla Ergin, Proff. Dr. - **Phone:** +90 262 303 10 00 - **Phone Ext:** 4701 - **Role:** CONTACT **Country:** Turkey **Facility:** Kocaeli University **Status:** RECRUITING **Zip:** 41380 #### Overall Officials **Official 1:** **Affiliation:** ergina@kocaeli.edu.tr **Name:** Ayla Ergin, Prof. Dr. **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** ebesemagunes@gmail.com **Name:** Sema Güneş Yanık, Graduate st **Role:** STUDY_CHAIR ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414525 **Brief Title:** Effect of Abdominal Massage Versus Visceral Manipulation on Constipation **Official Title:** Effect of Abdominal Massage Versus Visceral Manipulation on Constipation Status and Quality of Life in Adults #### Organization Study ID Info **ID:** constipation #### Organization **Class:** OTHER **Full Name:** Cairo University ### Status Module #### Completion Date **Date:** 2024-08 **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:** 2024-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cairo University #### Responsible Party **Investigator Affiliation:** Cairo University **Investigator Full Name:** Mennat Allah Mohamed Ali Ahmed **Investigator Title:** head of department of physical therapy AboKhalefa hospital **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The study compares the effect of abdominal massage vs. visceral manipulation on constipation status and quality of life in adults. Chronic idiopathic constipation (CIC) is considered a common functional bowel disorder characterized by difficult, infrequent, and/or incomplete defecation. It has a great impact on the quality of life and on the healthcare system and represents an important financial strain . ### Conditions Module **Conditions:** - Constipation Chronic Idiopathic **Keywords:** - chronic idiopathic constipation - abdominal massage - visceral manipulation - quality of life ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 75 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The technique involves stroking and kneading the abdomen in a consistent pattern. **Intervention Names:** - Other: abdominal massage **Label:** Abdominal massage **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** The technique involves visceral connective tissue manipulation. **Intervention Names:** - Other: visceral manipulation **Label:** visceral manipulation **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** instructions on daily, dietary, toilet, and physical activity habits **Intervention Names:** - Other: instructions on daily, dietary , toilet , and physical activity habits **Label:** control **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Abdominal massage **Description:** It will include patients that will receive abdominal massage; the frequency and duration of the massage will be arranged as 3 sessions per week, with each session lasting an average of 20-25 minutes for 6 weeks. **Name:** abdominal massage **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - visceral manipulation **Description:** It will include patients that will receive visceral manipulation; the frequency and duration of the technique will be arranged as 3 sessions per week, with each session lasting an average of 20-25 minutes for 6 weeks. **Name:** visceral manipulation **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - control **Description:** It will include patients that will receive behavioral therapy: defecation mechanism and informing about negative attitudes and behaviors towards defecation), lifestyle advice (diet, water consumption, fiber food, etc.), teaching effective defecation posture, and timed toilet training. **Name:** instructions on daily, dietary , toilet , and physical activity habits **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Constipation Severity Instrument (CSI) will be used to evaluate the severity of the constipation. The Constipation Severity Instrument is a 16-item patient-reported outcome measure that investigates symptoms of constipation based on frequency, severity, and bother of symptoms. CSI consists of three subscales: obstructive defecation, colonic inertia, and pain. Higher scores of CSI indicate more severe constipation. **Measure:** Constipation Severity Instrument (CSI) **Time Frame:** 6 weeks **Description:** Constipation assessment scale will be used to evaluate the severity of the constipation. The constipation assessment scale is a eight-item scale that assess the presence and severity of constipation. The patient rates each constipation item on a three-point scale (no problem to severe problem). Total scores range from 0 (no constipation) to 16 (worst possible constipation). **Measure:** Constipation Assessment Scale **Time Frame:** 6 weeks **Description:** Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) will be used to evaluate quality of life. PAC-QOL consists a total of 28 items in four subscales: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items). Higher scores of PAC-QOL indicate more negative effects of constipation on the quality of life. **Measure:** Patient Assessment of Constipation- Quality of Life (PAC-QOL) Questionnaire **Time Frame:** 6 weeks **Description:** (Scale 0 - 100), will be calculated as the mean of three variables (ease of defecation, feeling of incomplete bowel evacuation, and personal judgement of constipation) was developed to evaluate bowel function. **Measure:** Bowel Function Index **Time Frame:** 6 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients of both sex with age ranges (20-40) years old. * having a diagnosis of functional constipation according to Rome IV criteria onset of constipation symptoms from 6-12 months . * having body mass index 18.5-29.9 kg/m2 , waist height ratio \</=0.5 * Subjects bothered by their constipation Exclusion Criteria: * Pregnancy. * Having comorbidities (chronic pelvic pain, neurological (Parkinson's, multiple sclerosis, spinal cord lesion, etc.), metabolic / endocrine (diabetes mellitus, hypercalcemia, hypothyroid, etc.), cardiorespiratory diseases * Health problems which may prevent standing from sitting, walking (orthopedic, neurological, cardiorespiratory, etc.) * Malignancy, acute inflammation, intestinal tumor * History of gastrointestinal and pelvic surgery or spinal surgery other than cholecystectomy, appendectomy, or hysterectomy * Visual, auditory or cognitive problems which may prevent participation to the study. * Tumor, presence of skin problems in the application area * Presence of laxative use for functional constipation in the last four weeks or patients on laxative therapy. * Alarm symptoms (unexplained, more than 10% weight loss in 3 months, hemorrhoids and anal fissures, rectal bleeding, family history of colon cancer) **Maximum Age:** 40 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** mennamohamed309@gmail.com **Name:** Mennat Allah Ahmed **Phone:** 01228423121 **Role:** CONTACT #### Locations **Location 1:** **City:** Ismailia **Country:** Egypt **Facility:** Abo Khalefa emergency hospital **Status:** RECRUITING ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012817 - Term: Signs and Symptoms, Digestive ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M6472 - Name: Constipation - Relevance: HIGH - As Found: Constipation - ID: M15622 - Name: Signs and Symptoms, Digestive - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003248 - Term: Constipation ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414512 **Brief Title:** Optimizing the Dose of Flucytosine for the Treatment of Cryptococcal Meningitis **Official Title:** Optimizing the Dose of Flucytosine for the Treatment of Cryptococcal Meningitis #### Organization Study ID Info **ID:** STUDY00017800 #### Organization **Class:** OTHER **Full Name:** University of Minnesota ### Status Module #### Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-09 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Minnesota #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False ### Description Module **Brief Summary:** Cryptococcal meningitis (CM) is a fungal infection that causes a severe syndrome of meningitis that is 100% fatal without antifungal therapy. Even with antifungal therapy, mortality rates remain high, especially in Africa where the ongoing HIV/AIDS pandemic leads to higher prevalence of cryptococcosis. Combination of amphotericin and flucytosine (5-FC) is the mainstay of therapy for the initial management of CM. Indeed, it has even been shown that effective delivery of these therapies in Africa can lower mortality rates by 90%. This is a prospective open-label trial to compare the efficacy and safety of lower doses of 5FC during induction therapy to historical controls with standard 5FC dosing. Participants in the trial will receive 60mg/kg/day of 5-FC in 3 divided doses for 10 days. Single-dose liposomal amphotericin (10mg/kg) is preferred, if available. Amphotericin B 0.7-1.0 mg/kg/day may be used if needed. Historical controls drawn from the AMBITION trial will be used as a comparison group, selected weighted by inclusion/exclusion criteria, baseline characteristics and therapies received. Induction therapy for control group participants followed the 2018 WHO cryptococcal guidelines with 7 days of 5-FC 100mg/kg/day and 7 days of IV Amphotericin deoxycholate followed by 1200mg fluconazole/day for 7 days. The intervention group received single- dose liposomal amphotericin plus 5-FC and fluconazole 1200 mg/day. All participants will receive fluconazole 1200mg/day during consolidation therapy from day 1 to 14 then 800mg/day from day 15 to 10 weeks, and 200mg/day after 10 weeks. All participants will receive lumbar punctures at diagnosis, day 3, day 5-7, day 10-14, and additionally as required for control of intracranial pressure and documentation of CSF sterilization. Controls from Ambition will be matched for the same LP windows. Therapeutic LPs conducted during the first week have a \~70% relative survival benefit. ### Conditions Module **Conditions:** - Cryptococcal Meningitis ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** PARALLEL **Intervention Model Description:** Prospective, open-label trial to compare the efficacy and safety of lower doses of 5FC during induction therapy to historical controls with standard 5FC dosing. Historical controls drawn from the AMBITION trial will be used as a comparison group, selected weighted by inclusion/exclusion criteria, baseline characteristics and therapies received. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Historical controls drawn from the AMBITION trial will be used as a comparison group, selected weighted by inclusion/exclusion criteria, baseline characteristics and therapies received. **Intervention Names:** - Drug: AMBITION trial control **Label:** control **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** HIV-infected persons in Uganda with cryptococcal meningitis **Intervention Names:** - Drug: Flucytosine **Label:** Low Dose Flucytosine **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - control **Description:** Induction therapy for control group participants followed the 2018 WHO cryptococcal guidelines with 7 days of 5-FC 100mg/kg/day and 7 days of IV Amphotericin deoxycholate followed by 1200mg fluconazole/day for 7 days. **Name:** AMBITION trial control **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Low Dose Flucytosine **Description:** Participants in the trial will receive 60mg/kg/day of 5-FC in 3 divided doses for 10 days. Single-dose liposomal amphotericin (10mg/kg) is preferred, if available. Amphotericin B 0.7-1.0 mg/kg/day may be used if needed. **Name:** Flucytosine **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** quantified by the change of log 10 Cryptococcus CFU/mL CSF/day as measured by serial quantitative CSF fungal cultures over \~2 weeks **Measure:** Rate of CSF Cryptococcus clearance (Early Fungicidal Activity, or EFA) **Time Frame:** 2 weeks #### Secondary Outcomes **Measure:** CSF culture sterility cumulative incidence over 18 weeks **Time Frame:** 18 weeks **Measure:** 18-week survival time **Time Frame:** 18 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * CSF cryptococcal antigen (CrAg) positive meningitis * Ability and willingness to provide informed consent * Willing to receive protocol-specified lumbar punctures Exclusion Criteria: * Age \<18 years * Inability to take enteral (oral or nasogastric) medicine * Cannot or unlikely to attend regular clinic visits * Receiving chemotherapy or corticosteroids * Suspected Paradoxical immune reconstitution inflammatory syndrome (IRIS) * Pregnancy or breastfeeding * CrCl \< 20 mL/minute * Absolute neutrophil count \<500 x10 6 cells/L * Thrombocytopenia \< 50,000 x 10 6 cells/L * Patients with prior 5-flucytosine exposure \>3 days in the 12 months prior to enrollment * Any condition for which participation would not be in the best interest of the participant or that could limit protocol specified assessments. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** coat.trial@gmail.com **Name:** David Boulware **Role:** CONTACT #### Locations **Location 1:** **City:** Kampala **Contacts:** ***Contact 1:*** - **Email:** coat.trial@gmail.com - **Name:** David Boulware - **Role:** CONTACT **Country:** Uganda **Facility:** Infectious Disease Institute, Mulago Hospital Complex **Status:** RECRUITING **Zip:** 22418 **Location 2:** **City:** Mbarara **Contacts:** ***Contact 1:*** - **Email:** coat.trial@gmail.com - **Name:** David Boulware - **Role:** CONTACT **Country:** Uganda **Facility:** Mbarara University of Science and Technology **Status:** RECRUITING **Zip:** 1410 #### Overall Officials **Official 1:** **Affiliation:** University of Minnesota **Name:** David B Meya **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** University of Minnesota **Name:** David R Boulware **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000090862 - Term: Neuroinflammatory Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000016921 - Term: Meningitis, Fungal - ID: D000020314 - Term: Central Nervous System Fungal Infections - ID: D000009181 - Term: Mycoses - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000007239 - Term: Infections - ID: D000003453 - Term: Cryptococcosis - ID: D000002494 - Term: Central Nervous System Infections - ID: D000002493 - Term: Central Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M19263 - Name: Meningitis, Cryptococcal - Relevance: HIGH - As Found: Cryptococcal Meningitis - ID: M11564 - Name: Meningitis - Relevance: HIGH - As Found: Meningitis - ID: M2803 - Name: Neuroinflammatory Diseases - Relevance: LOW - As Found: Unknown - ID: M19265 - Name: Meningitis, Fungal - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M22126 - Name: Central Nervous System Fungal Infections - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown - ID: M6664 - Name: Cryptococcosis - Relevance: LOW - As Found: Unknown - ID: M5743 - Name: Central Nervous System Infections - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: T1668 - Name: Cryptococcosis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016919 - Term: Meningitis, Cryptococcal - ID: D000008581 - Term: Meningitis ### Intervention Browse Module - Ancestors - ID: D000000935 - Term: Antifungal Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M8565 - Name: Flucytosine - Relevance: HIGH - As Found: Bad - ID: M4002 - Name: Amphotericin B - Relevance: LOW - As Found: Unknown - ID: M255436 - Name: Liposomal amphotericin B - Relevance: LOW - As Found: Unknown - ID: M18296 - Name: Fluconazole - Relevance: LOW - As Found: Unknown - ID: M7036 - Name: Deoxycholic Acid - Relevance: LOW - As Found: Unknown - ID: M6252 - Name: Clotrimazole - Relevance: LOW - As Found: Unknown - ID: M11796 - Name: Miconazole - Relevance: LOW - As Found: Unknown - ID: M4254 - Name: Antifungal Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000005437 - Term: Flucytosine ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414499 **Brief Title:** Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ(TRACE Ⅳ) **Official Title:** TNK-tPA Treatment for Acute Minor Ischemic Stroke：A Multicenter, Prospective, Open Label, Blinded-endpoint, Randomized Controlled Trial #### Organization Study ID Info **ID:** NCRC-2024-03 #### Organization **Class:** OTHER **Full Name:** Beijing Tiantan Hospital ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-07-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Beijing Tiantan Hospital #### Responsible Party **Investigator Affiliation:** Beijing Tiantan Hospital **Investigator Full Name:** Yongjun Wang **Investigator Title:** professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The trial is a multicenter, prospective, open-label, blinded-endpoint randomized controlled design. Participants with acute minor ischemic stroke (baseline NIHSS≤5) accompanied with measurable neurological deficit will be randomized 1:1 to 0.25mg/kg intravenous tenecteplase or standard medical treatment. **Detailed Description:** The study will be a multicenter, prospective, open-label, blinded-endpoint randomized controlled trial (2 arms with 1:1 randomization). Participants with acute minor ischemic stroke (baseline NIHSS≤5) within 4.5 hours of symptoms onset (symptom onset is defined by the "last seen normal" principle for wake-up stroke) accompanied with measurable neurological deficit will be enrolled. The measurable neurological deficit is defined as impairment of language or motor function. Participants will be randomized into 2 groups: Intervention group (rhTNK-tPA): 0.25mg/kg, the maximum dose does not exceed 25mg. Control group (standard medical care): Single/dual antiplatelet therapy (aspirin, clopidogrel, ticagrelor, etc.) according to the guideline. The primary endpoint is excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90-day. ### Conditions Module **Conditions:** - Tenecteplase - Minor Ischemic Stroke ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 1874 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Within 4.5 hours of symptom onset: Intervention group (rhTNK-tPA): 0.25mg/kg, the maximum dose does not exceed 25mg: 1 vial is dissolved in 3ml of sterile water for injection to prepare a medicinal solution with a concentration of 5.33mg/ml. Calculate the total amount of the drug according to the weight of participant, and the maximum dose shall not exceed 25 mg. It is administered as a single bolus intravenous injection, and the injection is completed within 5-10 seconds. **Intervention Names:** - Drug: rhTNK-tPA **Label:** rhTNK-tPA **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Within 4.5 hours of symptom onset: Control group (standard medical care): Single/dual antiplatelet therapy (aspirin, clopidogrel, ticagrelor, etc.) according to the guideline. **Intervention Names:** - Drug: Single/dual antiplatelet therapy **Label:** Standard medical care **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - rhTNK-tPA **Description:** 0.25mg/kg, the maximum dose does not exceed 25mg: 1 vial is dissolved in 3ml of sterile water for injection to prepare a medicinal solution with a concentration of 5.33mg/ml. Calculate the total amount of the drug according to the weight of participant, and the maximum dose shall not exceed 25 mg. It is administered as a single bolus intravenous injection, and the injection is completed within 5-10 seconds. **Name:** rhTNK-tPA **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Standard medical care **Description:** Single/dual antiplatelet therapy (aspirin, clopidogrel, ticagrelor, etc.) according to the guideline. **Name:** Single/dual antiplatelet therapy **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Modified Rankin Scale score, mRS 0-1 **Measure:** Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90-day (± 7 days). **Time Frame:** at 90-day (± 7 days) #### Secondary Outcomes **Measure:** Good functional outcome (mRS 0-2) at 90-day (± 7 days) **Time Frame:** at 90-day (± 7 days) **Measure:** Ordinal distribution of mRS scores at 90-day (± 7 days) **Time Frame:** at 90-day (± 7 days) **Measure:** NIHSS 0-1 at 24-hour, 7-day or discharge (analyze which occurs first) or/ neurological improvement (NIHSS decreased≥2 from baseline) **Time Frame:** at 24-hour, 7-day or discharge (analyze which occurs first) **Measure:** Neurological impairment (NIHSS increased≥4 from baseline) at 90-day (± 7 days) **Time Frame:** at 90-day (± 7 days) **Measure:** New clinical vascular events (ischemic stroke/ hemorrhagic stroke/ myocardial infarction/vascular death) at 90-day (± 7 days), with each vascular event being independently evaluated. **Time Frame:** at 90-day (± 7 days) **Measure:** Symptomatic intracranial hemorrhage according to the ECASSIII criteria at 36-hour, 7-day or discharge (analyze which occurs first). **Time Frame:** at 36-hour, 7-day or discharge (analyze which occurs first) **Measure:** Symptomatic intracranial hemorrhage according to the ECASSIII criteria at 90-day (± 7 days) **Time Frame:** at 90-day (± 7 days) **Measure:** PH2 type intracranial hemorrhage according to the SITS criteria at 90-day (± 7 days) **Time Frame:** at 90-day (± 7 days) **Measure:** Any intracranial hemorrhage at 90-day (± 7 days) **Time Frame:** at 90-day (± 7 days) **Measure:** Moderate and severe bleeding events according to the GUSTO criteria at 90-day (± 7 days) **Time Frame:** at 90-day (± 7 days) **Measure:** Total mortality at 90-day (± 7 days) **Time Frame:** at 90-day (± 7 days) **Measure:** Adverse events/Severe adverse events reported by investigators at 90-day (± 7 days) **Time Frame:** at 90-day (± 7 days) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria 1. Age ≥ 18 years; 2. Can be treated with study drug within 4.5 hours of symptoms onset\*(\*Symptom onset is defined by the "last seen normal" principle); 3. Clinical diagnosis of minor ischemic stroke (baseline NIHSS≤5) with a measurable neurological deficit defined as impairment of language or motor function; 4. Pre-stroke mRS 0-1; 5. Informed consent signed. Exclusion Criteria 1. Planned or likely to receive acute endovascular treatments (any angioplasty or vascular surgery); 2. NIHSS 1a \> 2; 3. Known allergic to rhTNK-tPA; 4. Known history of intracranial hemorrhage; 5. Clinical stroke or serious head/spinal trauma within 3 months; 6. Intracranial or spinal surgery within 3 months; 7. Known history of gastrointestinal or urinary tract hemorrhage in the previous 21 days. 8. Participants with a history of major surgery in the previous 14 days; 9. Arterial puncture at a non-compressible site in the previous 7 days. 10. Participants with intracranial tumors (excluding neuroectoderm origin, such as meningioma), huge intracranial aneurysm, or arterio-venous malformation. 11. Intracranial hemorrhage (including cerebral parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/epidural hematoma) 12. Participants with active visceral bleeding; 13. Participants with aortic arch dissection; 14. Participants with a known bleeding diathesis or with a platelet count \< 100×10\^9/L; 15. Participants with a systolic blood pressure ≥ 180 or a diastolic blood pressure ≥ 100 mmHg after repeated measurements and aggressive treatments; 16. Blood glucose \<50 or \> 400 mg/dl (\< 2.8 or \> 22.2 mmol / l); 17. Clear indication for anticoagulation (presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis); 18. Receive intravenous thrombolysis within 24 hours; 19. Receive direct oral anticoagulant therapy with international normalized ratio (INR) \> 1.7s or PT \> 15 s; 20. Receive low molecular weight heparin or heparinoid within 24 hours; 21. Receive thrombin inhibitors or factor Xa inhibitors within 48 hours; 22. Receive GP2b3a inhibitors within 72 hours; 23. Participants who have large areas (greater than one third of middle cerebral artery territory) of obvious low density on the baseline CT scan; 24. Participants with a seizure at onset thought to be presenting with postictal paralysis (Todd's paralysis) mimicking stroke. 25. Participants with severe infection, such as bacterial endocarditis, pericarditis, acute pancreatitis; 26. Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control; 27. Participation in another clinical study with an experimental product in the previous 3 months; 28. Participants deemed unsuitable for participation in this trial by the investigator or those for whom participation in this trial may result in greater risks. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** yongjunwang@ncrcnd.org.cn **Name:** Yongjun Wang, MD, PhD **Phone:** 86-13911172565 **Role:** CONTACT **Contact 2:** **Email:** jingj_bjttyy@163.com **Name:** Jing Jing, MD, PhD **Phone:** 86-15810312511 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** yongjunwang111@aliyun.com - **Name:** Yongjun Wang, Dr. - **Role:** CONTACT **Country:** China **Facility:** Beijing Tiantan Hospital **State:** Beijing **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Beijing Tiantan Hospital **Name:** Yongjun Wang, MD, PhD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020521 - Term: Stroke - 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: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M22306 - Name: Stroke - Relevance: LOW - As Found: Unknown - ID: M2400 - Name: Ischemic Stroke - Relevance: HIGH - As Found: Ischemic Stroke - ID: M10543 - Name: Ischemia - Relevance: HIGH - As Found: 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 - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000083242 - Term: Ischemic Stroke - ID: D000007511 - Term: Ischemia ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PlAggInh - Name: Platelet Aggregation Inhibitors - Abbrev: Antipy - Name: Antipyretics - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: FiAg - Name: Fibrinolytic Agents - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M1669 - Name: Clopidogrel - Relevance: LOW - As Found: Unknown - ID: M4548 - Name: Aspirin - Relevance: LOW - As Found: Unknown - ID: M1812 - Name: Ticagrelor - Relevance: LOW - As Found: Unknown - ID: M13849 - Name: Tissue Plasminogen Activator - Relevance: LOW - As Found: Unknown - ID: M1911 - Name: Tenecteplase - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414486 **Acronym:** GNIZEN **Brief Title:** Effects of Ginseng on Stress, Emotional and Cognitive Processing **Official Title:** Evaluation of the Effects of Botalys Red Panax Ginseng on Cognitive, Psychological and Emotional Processing in Stressed Adults #### Organization Study ID Info **ID:** GINZEN #### Organization **Class:** INDUSTRY **Full Name:** Botalys ### Status Module #### Completion Date **Date:** 2024-04-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-12-07 **Type:** ACTUAL #### Start Date **Date:** 2023-05-12 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Université Catholique de Louvain #### Lead Sponsor **Class:** INDUSTRY **Name:** Botalys #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study aims to confirm the positive effect of the Red Panax Ginseng on the cognitive performance and regulation of stress and fatigue in adults with moderate stress level. **Detailed Description:** This study has been designed as a randomized double-blind placebo-controlled interventional study. One hundred and fifty participants (aged between 18 and 60), presenting a moderate level of perceived stress, were randomly allocated to the control (placebo) or test (ginseng supplement) group. Participants will be supplemented during 3 weeks with those products. Cognitive performance and emotional processing will be measured with tests and questionnaires before (baseline) and at the end (3 weeks) of the intervention. Fasted blood glucose level will be measured in blood before (baseline) and at the end (3 weeks) of the intervention. ### Conditions Module **Conditions:** - Stress **Keywords:** - Panax ginseng - Stress - Fatigue - Emotion processing ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Comparative, randomized, placebo-controlled, double-blind, monocentric interventional study in parallel groups ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 150 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants received orally 1 tablet containing 200mg of Red Panax Ginseng for 4 weeks **Intervention Names:** - Dietary Supplement: Dietary supplement group **Label:** Dietary supplement group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants received orally 1 tablet similar to the test product, containing no active principle for 3 weeks **Intervention Names:** - Other: Placebo group **Label:** Control group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Dietary supplement group **Description:** One tablet per day for 3 weeks consumed for subjects randomized in the Dietary supplementation group. This will lead to an intake of 200mg per day of Red Panax Ginseng (corresponding to 22.4mg of ginsenosides and 20.2mg of rare ginsenosides). **Name:** Dietary supplement group **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Control group **Description:** One tablet per day consumed for 3 weeks for subjects randomized in the Control group. The product is composed of rice flour (50mg) and brown sugar (150mg). **Name:** Placebo group **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Comparison between groups of the adjusted for baseline stress level assessed by the Perceived Stress Scale (PSS) **Measure:** A decrease of stress level **Time Frame:** 3 weeks #### Secondary Outcomes **Description:** Comparison between groups of the adjusted for baseline of depression state (BDI) **Measure:** Evolution of depression state **Time Frame:** 3 weeks **Description:** Comparison between groups of the adjusted for baseline of anxiety state (STAI-S) **Measure:** Evolution of anxiety state **Time Frame:** 3 weeks **Description:** Comparison between groups of the adjusted for baseline of emotional processing assessed by the PANAS **Measure:** Evolution of emotional processing **Time Frame:** 3 weeks **Description:** Comparison between groups of the adjusted for baseline of fatigue level (PIC) **Measure:** Evolution of fatigue level **Time Frame:** 3 weeks **Description:** Comparison between groups of the adjusted for baseline of attentional performance assessed by the Reaction Time and Rapid Visual Information Processing subtests of CANTAB. **Measure:** Evolution of attentional performance **Time Frame:** 3 weeks **Description:** Comparison between groups of the adjusted for baseline of memory performance assessed by the Verbal Recognition Memory, Paired Associate Learning and Spatial Span subtests of CANTAB. **Measure:** Evolution of memory performance **Time Frame:** 3 weeks **Description:** Comparison between groups of the adjusted for baseline of executive functions performance assessed by the Multitasking Test and One Touch Stockings of Cambridge subtests of CANTAB. **Measure:** Evolution of executive functions performance **Time Frame:** 3 weeks **Description:** Comparison between groups of the adjusted for baseline of the intervention satisfaction of the volunteer, evaluated by a Likert scale **Measure:** The intervention satisfaction of the volunteer **Time Frame:** 3 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: I.1. Healthy woman or man, aged of 18 to 60 years (inclusive); I.2. With a moderate level of perceived stress (PSS scores ranging from 14 to 26); I.3. Provision of signed and dated informed consent form; I.4. Stated willingness to comply with all study procedures and availability for the duration of the study; I.5. Speaking French. Exclusion Criteria: E.1. Subject with severe medical or cognitive problems which, in the opinion of the Principal Investigator, could interfere with the evaluation of the study criteria or with participant safety; E.2. Subject with a coffee consumption of more than 5 cups per day; E.3. Subject consuming drugs and/or with historical drug addiction (\<5 years); E.4. Subject with alcohol consumption exceeding 3 glasses of wine per day, or two halves of a beer per day, or one glass of strong alcohol per day; E.5. Subject undergoing medical treatment which, in the opinion of the Principal Investigator, could interfere with cognitive and emotional processing; E.6. Subject with type 1 or type 2 diabetes; E.7. Subject participating in another intervention trial; E.8. Women of childbearing age who are pregnant or breastfeeding or who wish to become pregnant within the next 6 weeks or who are not using an adequate method of contraception (e.g. oral contraception, IUD, abstinence, ...). **Healthy Volunteers:** True **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Louvain-la-Neuve **Country:** Belgium **Facility:** Center of Investigation in Clinical Nutrition (CICN) **Zip:** 1348 #### Overall Officials **Official 1:** **Affiliation:** Université Catholique de Louvain **Name:** Louise Deldicque, Prof **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Université Catholique de Louvain **Name:** Sylvie Copine, Dr **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M8364 - Name: Fatigue - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Browse Branches - Abbrev: HB - Name: Herbal and Botanical - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T168 - Name: Ginseng - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414473 **Acronym:** SLACK-OA **Brief Title:** CBD for Knee Osteoarthritis **Official Title:** Sub-Lingual Administration of Cannabidiol for Knee Osteoarthritis #### Organization Study ID Info **ID:** IRB202301136 #### Organization **Class:** OTHER **Full Name:** University of Florida ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-04-24 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Florida #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** Osteoarthritis is a disease that affects millions of Americans and is the leading cause of persistent pain and physical disability in the older adult population. Many physically active Americans have reported pain-relieving effects of cannabidiol (CBD) that can reduce or eliminate use of nonsteroidal anti-inflammatory drugs (NSAIDs) for activity-related pain with minimal to no side effects. Long-term use of over-the-counter medications, including NSAIDs, can pose a significant health risk, and therefore clinical research on the safety and efficacy of CBD is needed. **Detailed Description:** Knee OA is the most common joint disease and a major cause of functional limitation and pain in adults. Pain is the primary symptom of OA, and the main reason people seek medical treatment. Although pharmacologic treatment for OA such as opioid-based medications may help in the short-term with reducing pain-related symptoms, they are known to have mild to severe side effects along with the potential for long-term dependency. Consequently, many Americans have turned to cannabis-related products like cannabidiol or CBD for reducing pain and pain-related symptoms associated with OA. Current research has shown evidence that phyto-cannabinoids may have a promising therapeutic potential in a variety of physical and psychological ailments, and cannabidiol (CBD) is of particular interest due to its positive safety profile, non-intoxicating effects, and purported therapeutic capabilities in several musculoskeletal diseases. In vitro and in vivo studies have shown that CBD administration in the short term is safe and effective in reducing inflammation and pain behaviors in animal models of OA. Despite the widespread popularity of CBD in the US, there is very limited data that indicates the safety, acceptability, and pain-relieving effects of CBD use for people with symptomatic knee osteoarthritis. The investigators' objective will be to conduct an early-stage clinical trial to investigate the safety, tolerability/acceptability, and efficacy of CBD as a non-pharmacological treatment for symptomatic knee OA. The investigators will conduct an innovative and novel study with rigorous scientific design that will assess and monitor symptomatic relief and improved function following CBD administration (active) or placebo-control using a randomized, double-blind, placebo-controlled, cross-over study design. The investigators will be recruiting 30 adult men and women, between 40 and 75 years of age, with an established clinical diagnosis of knee OA. To be included in the study, participants must report having moderate to severe knee pain (≥4/10) with physical activity in one or both knees. Subjects will be required to complete a 78-day study trial spanning a pre-dosing screening visit, baseline testing, 30-day dosing regimen with follow-up testing. A 2-week wash-out period will be followed by the cross-over phase using identical baseline and follow-up testing procedures. The data from the active CBD phase will be compared to data from the placebo-control phase. There is an extremely large consumer base for CBD-related products in the US, and this base will be expanding exponentially over the course of this decade; therefore, scientific investigation into its therapeutic potential is necessary. ### Conditions Module **Conditions:** - Osteoarthritis, Knee **Keywords:** - Cannabidiol - Osteoarthritis - Pain - Dysfunction - Physical Activity ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** Randomized, double-blind, placebo-controlled, clinical trial ##### Masking Info **Masking:** TRIPLE **Masking Description:** All participants, investigators, and study personnel will be blinded to treatment order assignments throughout the study. **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Hemp supplement is a full spectrum CBD-rich formulation (\~10%) containing very low levels of THC (\<0.3%), along with all naturally occurring minor cannabinoids, terpenes, and essential oils from the plant extract. **Intervention Names:** - Drug: Cannabidiol (CBD) Extract **Label:** Active Drug **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** A medium chain triglyceride-based mixing agent blended with coconut oil will be used as the placebo. **Intervention Names:** - Drug: Placebo **Label:** Vehicle Control **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Active Drug **Description:** Administered thrice daily (with food) using a sublingual route of administration **Name:** Cannabidiol (CBD) Extract **Other Names:** - Hemp Supplement **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Vehicle Control **Description:** Administered thrice daily (with food) using a sublingual route of administration **Name:** Placebo **Other Names:** - Vehicle Control **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Categorical scale, None or not at all (0) and very severe or very much (4), higher scores mean worse outcome **Measure:** Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) **Time Frame:** Weekly until 1 month **Description:** Likert scale, 1 and 5, higher scores mean worse outcome **Measure:** Theoretical Framework of Acceptability Questionnaire (TFAQ) **Time Frame:** Baseline and 1 month **Description:** Numeric Rating Scale, 0 and 10, higher scores mean worse outcome **Measure:** Self-report Ratings of Knee Pain **Time Frame:** Baseline and 1 month, daily until 1 month **Description:** Accelerometer measures step counts per day **Measure:** Physical Activity **Time Frame:** Daily until 1 month **Description:** Categorical scale, none (0) and extreme (4), higher scores mean worse outcome **Measure:** Western Ontario and McMaster Universities Arthritis Index (WOMAC) **Time Frame:** Baseline and 1 month #### Secondary Outcomes **Description:** A set of noninvasive tests used to assess pain sensitivity **Measure:** Quantitative Sensory Testing (QST) **Time Frame:** Baseline and 1 month **Description:** Timed Stair-climbing Test (sec) **Measure:** Physical Function **Time Frame:** Baseline and 1 month **Description:** Likert scale, 0 and 5, higher scores mean worse outcome **Measure:** Fear of Pain Questionnaire III (FPQ III) **Time Frame:** Baseline and 1 month **Description:** Likert scale, 0 and 4, higher scores mean worse outcome **Measure:** Pain Catastrophizing Scale (PCS) **Time Frame:** Baseline and 1 month **Description:** Likert scale, 0 and 5, higher scores mean worse outcome **Measure:** Pain Anxiety Symptom Scale (PASS-20) **Time Frame:** Baseline and 1 month **Description:** Categorical scale, Not during the past month to and Three or more times a week, higher scores mean worse outcome **Measure:** Pittsburgh Sleep Quality Index (PSQI) **Time Frame:** Baseline and 1 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. established clinical diagnosis of knee osteoarthritis (KOA) 2. moderate to severe knee pain (≥4/10) with physical activity in one or both knees Exclusion Criteria: 1. pregnant (urine pregnancy test) or lactating 2. current cannabis (THC and/or CBD) use (urine drug screen) 3. any prior or ongoing medical condition that, in the investigators' opinion, could adversely affect the safety of the subject 4. any major surgery within 3 months prior to recruitment or planned orthopedic surgery for any time during this study which would interfere with the ability to report pain or quality of life outcome measures 5. any exposure to another investigational drug within 3 months prior to screening 6. BMI ≥ 45 7. current use of any enzyme-modifying drugs, including strong inhibitors or strong inducers of cytochrome P (CYP) enzymes 8. history of: 1. suicidal ideation or self-harm behavior 2. seizure disorder or traumatic brain injury, 3. liver or kidney disease, and 4. cardiovascular diseases **Maximum Age:** 75 Years **Minimum Age:** 40 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** pborsa@ufl.edu **Name:** Paul A. Borsa, PhD **Phone:** 352-294-1726 **Role:** CONTACT **Contact 2:** **Email:** johnstauffer@ufl.edu **Name:** John W Stauffer, MS **Phone:** 352-294-1777 **Role:** CONTACT ## 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: BC23 - Name: Symptoms and General Pathology - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M12926 - Name: Osteoarthritis - Relevance: HIGH - As Found: Osteoarthritis - ID: M22168 - Name: Osteoarthritis, Knee - Relevance: HIGH - As Found: Osteoarthritis, Knee - 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: D000000927 - Term: Anticonvulsants ### Intervention Browse Module - Browse Branches - Abbrev: AntiConv - Name: Anticonvulsants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: M5445 - Name: Cannabidiol - Relevance: HIGH - As Found: Inhaler - ID: M4246 - Name: Anticonvulsants - Relevance: LOW - As Found: Unknown - ID: T119 - Name: Coconut - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000002185 - Term: Cannabidiol ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414460 **Brief Title:** Study of ISM3412 in Participants With Locally Advanced/Metastatic Solid Tumors **Official Title:** A Phase 1, Open-Label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Preliminary Efficacy of ISM3412 in Participants With Locally Advanced/Metastatic Solid Tumors #### Organization Study ID Info **ID:** ISM3412-101 #### Organization **Class:** INDUSTRY **Full Name:** InSilico Medicine Hong Kong Limited ### Status Module #### Completion Date **Date:** 2029-03-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-03-31 **Type:** ESTIMATED #### Start Date **Date:** 2025-03-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** InSilico Medicine Hong Kong Limited #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The study has consists of two parts, a dose escalation part (Part 1) and a dose selection optimization part (Part 2). The primary objectives of this study are to evaluate the safety and tolerability of ISM3412 in participants with locally advanced/metastatic solid tumors, and to determine the RP2D of ISM3412. ### Conditions Module **Conditions:** - Locally Advanced/Metastatic Solid Tumors **Keywords:** - Methionine adenosyltransferase 2A (MAT2A) - homozygous MTAP deletion - MAT2A inhibitor - ISM3412 ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will receive ISM3412 once daily in sequential cohorts of increasing doses. **Intervention Names:** - Drug: ISM3412 **Label:** Part 1 Dose Escalation **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will be randomized to receive one of the two selected dose levels of ISM3412 once daily determined by Study Review Committee. **Intervention Names:** - Drug: ISM3412 **Label:** Part 2 Dose Selection Optimization **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Part 1 Dose Escalation - Part 2 Dose Selection Optimization **Description:** ISM3412 will be administered orally once daily. **Name:** ISM3412 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** To evaluate the safety and tolerability of ISM3412. **Measure:** Incidence of dose-limiting toxicity (DLT) events **Time Frame:** 31 days **Description:** To evaluate the safety and tolerability of ISM3412. **Measure:** Incidence and severity of adverse events (AEs) **Time Frame:** Approximately 30 months **Description:** To determine the RP2D of ISM3412. **Measure:** Recommended phase 2 dose (RP2D) **Time Frame:** Approximately 30 months #### Secondary Outcomes **Description:** To assess PK of ISM3412 in plasma following a single and multiple doses of ISM3412 **Measure:** Maximum observed concentration (Cmax) **Time Frame:** Approximately 30 months **Description:** To assess PK of ISM3412 in plasma following a single and multiple doses of ISM3412 **Measure:** Time of maximum observed concentration (Tmax) **Time Frame:** Approximately 30 months **Description:** To assess PK of ISM3412 in plasma following a single and multiple doses of ISM3412 **Measure:** Area under the concentration-time curve (AUC) **Time Frame:** Approximately 30 months **Description:** To assess PK of ISM3412 in plasma following a single and multiple doses of ISM3412 **Measure:** Terminal half-life (t1/2) **Time Frame:** Approximately 30 months **Description:** To evaluate the preliminary efficacy of ISM3412 in participants with locally advanced/metastatic solid tumors. **Measure:** Objective response rate (ORR) **Time Frame:** Approximately 30 months **Description:** To evaluate the preliminary efficacy of ISM3412 in participants with locally advanced/metastatic solid tumors. **Measure:** Best objective response (BOR) **Time Frame:** Approximately 30 months **Description:** To evaluate the preliminary efficacy of ISM3412 in participants with locally advanced/metastatic solid tumors. **Measure:** Duration of response (DoR) **Time Frame:** Approximately 30 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Male or female participants with age ≥18 years at the time of signing the informed consent. 2. Histologically confirmed unresectable locally advanced or metastatic solid tumors with confirmed homozygous MTAP deletion, who have disease progression after standard therapy, intolerable to standard therapy, or for whom no standard therapy exists. 3. Have measurable or evaluable lesions in Part 1 and at least one measurable target lesion in Part 2 as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. 4. Participants must provide a documentary evidence of homozygous MTAP deletion; or provide archival formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks or at least 15 FFPE tumor tissue slides, or perform tumor tissue biopsies for a confirmatory genetic test indicating homozygous MTAP deletion. 5. ECOG PS (Eastern Cooperative Oncology Group Performance Status) ≤1. 6. Life expectancy of ≥12 weeks as judged by the investigator. 7. Adequate organ function as determined by medical assessment. 8. Capable of providing signed ICF and complying with the requirements and restrictions listed in the ICF and in this study protocol. Exclusion Criteria: 1. Prior treated with other MAT2A inhibitors and/or PRMT inhibitors. 2. Participation in other therapeutic clinical studies within 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment. 3. Anti-tumor therapy (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, or other anti-tumor therapy, except for hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogues, agonists required to suppress serum testosterone levels) within 28 days or 5 half-lives, whichever is shorter prior to first dose of study treatment. 4. Toxicities of prior therapy have not resolved to Grade ≤1 or to baseline (as evaluated by NCI CTCAE version 5.0) 5. History of another primary tumor that has been diagnosed or required therapy within the past 3 years. 6. Previous history of, or presence of Gilbert's syndrome. 7. Previous history of myelodysplastic syndrome. 8. Prior solid organ or hematopoietic stem cell transplant. 9. Known active central nervous system (CNS) primary tumor or untreated CNS metastases. 10. Have serious cardiovascular or cerebrovascular disease as per protocol. 11. Presence of uncontrolled systemic infection as per protocol. 12. Unwillingness or unable to comply with the requirements of oral drug administration, or presence of a gastro-intestinal condition. Other protocol inclusion and exclusion criteria may apply. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Insilico-Clinicaltrial@insilico.ai **Name:** Yichen Liu **Phone:** +86 021-50831718 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: AA - Name: Amino Acids - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T12 - Name: Methionine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414447 **Brief Title:** Electrocardiogram (ECG) Validation Study **Official Title:** SANSA Electrocardiogram (ECG) Validation Study #### Organization Study ID Info **ID:** CP-10000 #### Organization **Class:** INDUSTRY **Full Name:** Huxley Medical, Inc. ### Status Module #### Completion Date **Date:** 2024-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Huxley Medical, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is Unapproved Device:** True **Is US Export:** True ### Description Module **Brief Summary:** Comparison of diagnostic Electrocardiogram (ECG) signals ### Conditions Module **Conditions:** - Arrythmia ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 15 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** diagnostic **Name:** Huxley Medical **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Measure:** Comparison of the diagnostic Electrocardiogram (ECG) signal quality of the P, QRS and T wave deflections of the Sansa device to a reference standard Holter monitor **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** INCLUSION CRITERIA * 18 years of age of older * Able to read, understand, and sign informed consent documentation willing to wear the Sansa device and 3-lead or 5-lead Holter monitor simultaneously for 24- hours * In the opinion of the investigator, subject is willing to comply with the protocol EXCLUSION CRITERIA * Noted deformities of the chest (e.g., pronounced scarring, pectus carinatum) that would Interfere with sensor placement * broken or injured skin that would interfere with sensor placement, are known to experience adverse reactions to medical-grade adhesive * pacemaker dependent * females who are pregnant (self-reported) **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** subjects willing to participate in an ECG diagnostic evaluation ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jfricke@huxleymed.com **Name:** Jill Fricke **Phone:** 949-310-4697 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - 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: M4453 - Name: Arrhythmias, Cardiac - Relevance: HIGH - As Found: Arrhythmia - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001145 - Term: Arrhythmias, Cardiac ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414434 **Brief Title:** BTX-A51 in Patients With Liposarcoma **Official Title:** A Pilot Study of BTX-A51 in Patients With Metastatic and/or Recurrent Liposarcomas Characterized by MDM2 Amplifications #### Organization Study ID Info **ID:** 24-156 #### Organization **Class:** OTHER **Full Name:** Dana-Farber Cancer Institute ### Status Module #### Completion Date **Date:** 2027-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-11 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Edgewood Oncology Inc. #### Lead Sponsor **Class:** OTHER **Name:** Michael Wagner #### Responsible Party **Investigator Affiliation:** Dana-Farber Cancer Institute **Investigator Full Name:** Michael Wagner **Investigator Title:** Sponsor Investigator **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study is testing if the recommended dose of BTX-A51 is safe and tolerable in participants with liposarcoma. The name of the study drug used in this research study is: -BTX-A51 (a type of kinase inhibitor) **Detailed Description:** This is a single arm, pilot study assessing the safety and preliminary exploration of BTX-A51 in participants with metastatic and/or recurrent liposarcomas characterized by Murine Double Minute Clone 2 (MDM2) amplifications. BTX-A51 works in a different way from currently approved therapies used to treat liposarcoma by blocking proteins called CK1α and CDK9. The U.S. Food and Drug Administration (FDA) has not approved BTX-A51 as a treatment for Liposarcoma. The research study procedures include screening for eligibility, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, or Positron Emission Tomography (PET) scans, blood tests, and tumor biopsies. Participants will receive study treatment for as long as there are no serious side effects, and disease does not get worse. Participants will be followed for 1 year after the last dose of BTX-A51. It is expected that about 12 people will take part in this research study. Edgewood Oncology is supporting this research study by providing the study drug. ### Conditions Module **Conditions:** - Liposarcoma - Recurrent Liposarcoma - Metastatic Liposarcoma - Unresectable Liposarcoma - MDM2 Gene Amplification **Keywords:** - Liposarcoma - Recurrent Liposarcoma - Metastatic Liposarcoma - Unresectable Liposarcoma - MDM2 Gene Amplification ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 12 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will be enrolled and will complete study procedures as follows: * Baseline visit with tumor biopsy. * Tumor biopsy at the end of Cycle 1. * Radiologic imaging every 2 cycles. * Cycle 1 through End of Treatment: --Day 1 of 28 day cycle: Predetermined dose of BTX-A51 3x weekly. * End of Treatment visit with radiologic imaging. * Follow-up: every 3 months for 1 year. **Intervention Names:** - Drug: BTX-A51 **Label:** BTX-A51 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - BTX-A51 **Description:** Multi-kinase inhibitor, 1.0 mg, 2.0 mg, and 7.0 mg immediate-release capsules, taken orally per protocol. **Name:** BTX-A51 **Other Names:** - C32H41ClN6O6S2 - (1r,4r)-N 1-(5-chloro-4-(5-(cyclopropylmethyl)-1-methyl-l H pyrazol-3-yl)pyrimidin-2-yl)cyclohexane-l ,4-diamine bis(4-methylbenzenesulfonate), **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Safety and tolerability will be monitored through continuous reporting of treatment-emergent and treatment-related adverse events, laboratory abnormalities, and incidence of subjects experiencing dose modifications, delays, interruptions, or premature discontinuation of BTX-A51 due to an adverse event. Toxicities are to be assessed according to the CTCAEv5. **Measure:** Number of participants with adverse events, with laboratory abnormalities, with dose modifications, delays, interruptions, or premature discontinuation of BTX-A51 due to an adverse event **Time Frame:** All AEs will be recorded from the time the subject signs informed consent until 30 days after the last dose of study BTX-A51. #### Secondary Outcomes **Description:** The overall response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on RECISTv1.1 criteria. **Measure:** Overall Response Rate (ORR) **Time Frame:** ORR expected to be observed up to 3 years **Description:** 1-year PFS is a probability estimated using progression-free survival based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) or death, or is censored at time of last disease assessment. **Measure:** 1-year Progression-Free Survival (PFS) Rate **Time Frame:** 1 year **Description:** 1-year OS is a probability estimated using the Kaplan-Meier method; OS is defined as the time from study entry to death, or censored at date last known alive. **Measure:** 1-year Overall Survival (OS) **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Study participants must have histologically-confirmed metastatic and/or recurrent liposarcoma (limited to the subtypes of well-differentiated and/or dedifferentiated liposarcoma, which are associated with MDM2 amplifications). * ECOG performance status ≤2 * Adequate organ and marrow function as defined by the following metrics resulted within 7 days of study enrollment: * WBC \>3000/mm3 * Platelets \>75,000μl * ANC \>1500μl * Hgb \>9g/dl * Creatinine \<1.5 x ULN or measured CrCl of \>60ml/m2/1.73 m2 * Total bilirubin \<2 x ULN * AST/ALT \<3 x ULN * Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non- nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. See Section 11 (Measurement of Effect) for the evaluation of measurable disease. * Patients must have recovered from toxicity related to prior therapy to grade \<=1 (defined by CTCAE v5.0) (except alopecia and neuropathy, or immunotherapy related hypothyroidism) * As the effect of this study drug on the developing human fetus is not known, women of child-bearing potential and men must agree to use at least 2 methods of contraception (abstinence; hormonal or barrier method of birth control) for the study and at least 2 months after completion. * Female patient of childbearing potential has a negative serum pregnancy test within 7 days of study enrollment. * Ability to understand and the willingness to sign a written informed consent document. * Age ≥18 years * Patients must have completed all prior anti-cancer treatment for liposarcoma, including radiation, ≥ 14 days prior to registration. Exclusion Criteria: * Patient with current evidence of active and uncontrolled infection, NYHA Class III-IV CHF, documented Child's class B-C cirrhosis, or uncontrolled medical disease which in the opinion of the investigator or the sponsor could compromise safety and/or assessment of efficacy. * Active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV); subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative PCR result before enrollment; those who are PCR positive will be excluded. * Major surgical procedure or open surgical biopsy within 28 days of first dose of study drug * Active central nervous system (CNS) disease involvement, or prior history of NCI CTCAE Grade ≥3 drug-related CNS toxicity. Subject with known CNS metastases that are treated and stable (without evidence of CNS toxicity) and are not requiring systemic steroids are allowed to be enrolled. * Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial * Myocardial infarction within 12 months of screening * Use of any other concurrent investigational agents or anticancer agents, excluding hormonal therapy for breast or prostate cancer * Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with BTX- A51, breastfeeding should be discontinued if the mother is treated with BTX-A51. * Inability to swallow pills or inadequate GI absorption in the opinion of the treating investigator. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** MICHAEL_WAGNER@DFCI.HARVARD.EDU **Name:** Michael Wagner, MD **Phone:** 617-632-5204 **Role:** CONTACT **Contact 2:** **Email:** MICHAEL_WAGNER@DFCI.HARVARD.EDU **Name:** Michael Wagner, MD **Phone:** 617-632-3352 **Role:** CONTACT #### Locations **Location 1:** **City:** Boston **Contacts:** ***Contact 1:*** - **Email:** michael_wagner@dfci.harvard.edu - **Name:** Michael Wagner, MD - **Phone:** 617-632-3352 - **Role:** CONTACT ***Contact 2:*** - **Name:** Michael Wagner, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Brigham and Women's Hospital **State:** Massachusetts **Zip:** 02215 **Location 2:** **City:** Boston **Contacts:** ***Contact 1:*** - **Email:** michael_wagner@dfci.harvard.edu - **Name:** Michael Wagner, MD - **Phone:** 617-632-3352 - **Role:** CONTACT ***Contact 2:*** - **Name:** Michael Wagner, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Dana-Farber Cancer Institute **State:** Massachusetts **Zip:** 02215 #### Overall Officials **Official 1:** **Affiliation:** Dana-Farber Cancer Institute **Name:** Michael Wagner, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu **Description:** The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research. **Info Types:** - STUDY_PROTOCOL - SAP **IPD Sharing:** YES **Time Frame:** Data can be shared no earlier than 1 year following the date of publication ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000018205 - Term: Neoplasms, Adipose Tissue - ID: D000018204 - Term: Neoplasms, Connective and Soft Tissue - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000012509 - Term: Sarcoma ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11080 - Name: Liposarcoma - Relevance: HIGH - As Found: Liposarcoma - ID: M14850 - Name: Recurrence - Relevance: HIGH - As Found: Recurrent - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M20351 - Name: Neoplasms, Adipose Tissue - Relevance: LOW - As Found: Unknown - ID: M20350 - Name: Neoplasms, Connective and Soft Tissue - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M15327 - Name: Sarcoma - Relevance: LOW - As Found: Unknown - ID: T3479 - Name: Liposarcoma - Relevance: HIGH - As Found: Liposarcoma - ID: T5284 - Name: Soft Tissue Sarcoma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008080 - Term: Liposarcoma - ID: D000012008 - Term: Recurrence ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: VaCoAg - Name: Vasoconstrictor Agents - Abbrev: Resp - Name: Respiratory System Agents ### Intervention Browse Module - Browse Leaves - ID: M21257 - Name: Botulinum Toxins, Type A - Relevance: LOW - As Found: Unknown - ID: M250193 - Name: abobotulinumtoxinA - Relevance: LOW - As Found: Unknown - ID: M7992 - Name: Epinephrine - Relevance: LOW - As Found: Unknown - ID: M198097 - Name: Pyrazole - Relevance: LOW - As Found: Unknown - ID: M30371 - Name: Racepinephrine - Relevance: LOW - As Found: Unknown - ID: M211043 - Name: Epinephryl borate - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414421 **Brief Title:** The Effect of TENS on Pain, Complications and Comfort in Patients Who Had Prostate Biopsy With Transrectal Ultrasound **Official Title:** The Effect of Transcute Electrical Nerve Stimulation On Pain, Complication and Comfort in Patients Who Undergo Prostate Biopsy With Transrectal Ultrasound #### Organization Study ID Info **ID:** CukurovaUSFırat #### Organization **Class:** OTHER **Full Name:** Cukurova University ### Status Module #### Completion Date **Date:** 2023-12-27 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-03-31 **Type:** ACTUAL #### Start Date **Date:** 2021-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2023-12-13 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cukurova University #### Responsible Party **Investigator Affiliation:** Cukurova University **Investigator Full Name:** Sevda Fırat **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:** Prostate cancer is one of the most common types of malignancy in men. Transrectal Ultrasound Guided Prostate Biopsy (TRUSG-PBx) is considered the gold standard method. The present, Transrectal ultrasound guided prostate biopsy is considered the gold standard method in the diagnosis of prostate cancer. During the process, patients experience severe discomfort and pain, although anesthetics and analgesics are used. In addition to pharmacological methods, non-pharmacological methods are also used in the control of pain caused by diagnosis and treatment interventions. Transcutaneous Electrical Nerve Stimulation (TENS) is among the non-pharmacological methods and it is the most widely used electroanalgesia method. In this randomized controlled intervention research, the effect of TENS application will be evaluated on pain, complications and comfort level during and after the procedure in patients who underwent Transrectal Ultrasound-Guided Prostate Biopsy. Thanks to this research, it is thought that the pain level and complications will decrease and the comfort level will increase in patients who undergo TENS application. The research will be carried out in Çukurova University Faculty of Medicine Balcalı Application and Research Hospital Urology Outpatient Clinic. The sample of the research will create volunteer patients, providing research criteria and made prostate biopsy in Urology Outpatient Clinic. Patients consisting of 2 groups as control and experimental (TENS applied) will be determined by randomization. In the power analysis calculated with statistical support, confidence interval of 95%, alpha value 0.05, beta value calculated with 80% power, a total of 80 patients will be included in the control and experimental group, including 40 patients each. The data will be collected by "Personal Information Form", "Pain Assessment Form", "TRUSG-PBx Complication Follow-up Form", "Perianesthesia Comfort Scale Form". The data obtained will be analyzed in SPSS (Statisticial Package for the Social Sciences) package program. In this context, our research, a comparison will be made by evaluating the effect of TENS application on pain, complications and comfort, in patients who underwent transrectal ultrasound-guided prostate biopsy. These results, non-pharmacological methods will make great contributions to improving patient outcomes in diagnostic interventions. Keywords: Pain, Nurse, Comfort, Prostate Biopsy and Complications, Transcutaneous Electrical Nerve Stimulation (TENS). **Detailed Description:** Prostate cancer is one of the most common types of malignancy in men. According to GLOBOCAN (Global cancer statistics) 2020 data, the age-standardized incidence rate of prostate cancer varies between 37.5-11.3 per hundred thousand in the world, depending on the development level of the countries, and it is seen to be 42.5 per hundred thousand in our country. It ranks second after lung cancer in terms of incidence in men in our country and in the world. Prostate cancer screening aims to reduce mortality and morbidity by detecting prostate cancer at an early stage. In the diagnosis of prostate cancer, digital rectal examination (DRE), prostate specific antigen (PSA) value, transrectal ultrasonography (TRUSG) and biopsy are used. Transrectal ultrasound-guided prostate biopsy (TRUSG-PBx) is currently considered the gold standard method in the diagnosis of prostate cancer. In the TRUSG-guided biopsy procedure, patients are placed in the left lateral or lithotomy position, a needle-guided rectal probe is inserted into the anal canal with the help of lubricating gel, and the prostate tissue is monitored under ultrasound guidance and a biopsy is taken. The procedure takes approximately 20-30 minutes, and insertion and removal of the probe into the rectal area takes approximately 10-15 minutes in total. TRUSG-PBx is a cost-effective, accessible invasive procedure that has undergone significant changes and developments over the years, is well tolerated, has minimally serious, undesirable side effects and complications, can be easily and quickly performed in outpatient conditions. However, although it is a safe method with a low complication rate, each patient must be carefully monitored because it is an invasive procedure. Complications frequently include hematuria, hematospermia, rectal bleeding, dysuria, urinary retention, hematochezia, erectile dysfunction, infection, prostatitis and pain. In most patients who will undergo transrectal biopsy, the possibility of the result being cancer and the psychological discomfort caused by the fact that the procedure will be performed rectally increase the pain. Although prostate biopsy is thought to be well tolerated by patients, it appears to cause discomfort and pain in 65% to 90% of cases. Failure to recognize and deal with this problem not only affects patients' willingness to undergo the procedure again if necessary, but can also potentially lead to forgoing prostate evaluation or rejection of the procedure for fear of a painful invasive procedure. In addition, the importance of pain control has gradually increased due to prostate biopsy being performed on younger patients, biopsies being taken from more quadrants, and repeated prostate biopsies. Due to severe pain, the rate of tolerance of the procedure by the patient decreases, and this may lead to a decrease in the number of biopsy samples taken from the planned quadrant and a decrease in cancer detection rates. Therefore, it is extremely important to ensure pain control and increase patient tolerance and comfort in TRUSG-PBx. The pain felt during the biopsy occurs for 2 reasons. The first is pain caused by stretching of the anal sphincter as the transrectal ultrasound probe enters the anus (passing the ultrasound probe through the anus, advancing it into the rectum, and manipulating it within the rectum). Especially before biopsy, periprostatic nerve blockade requires penetration into the rectum with a rectal probe before anesthesia, and this first penetration causes the patients' complaints. The second is the pain felt when the biopsy needle penetrates the prostate capsule and enters the prostatic stroma. Pharmacological methods such as local anesthetics, peripheral nerve blockade, spinal and intravenous (IV) sedation applications have been used to reduce pain and discomfort, and results have been reported showing that these methods increase pain tolerance in the patient. The increasing use of active surveillance and the acceptance of prostate biopsy for prostate cancer management are very important to relieve or reduce patients' discomfort during biopsy and optimize satisfaction and comfort. Although TRUSG-PBx is easy to perform and causes very low mortality, there is a need to develop new protocols for analgesia before the procedure to reduce the discomfort and pain that patients may feel. Nurses should also apply non-pharmacological methods to reduce the consumption of analgesic drugs or increase their effect by providing adequate analgesia. Nurses, who have a key role in the pain management team, should do what is necessary about pain preventive approaches and pain control methods at this stage. Non-pharmacological methods are important in providing comfort and a feeling of control, improving functionality and quality of life, and reducing pain and anxiety. TRUSG-PBx is a challenging diagnostic procedural intervention due to pain and fear for patients. For this reason, non-pharmacological methods should be used and pharmacological methods should be integrated into nursing practices in order to tolerate the procedure by patients and ensure effective pain control. Among the non-pharmacological methods that can be used safely in acute painful interventions, Transcutaneous Electrical Nerve Stimulation (TENS) is an effective electroanalgesia method. This method is a method of applying controlled low-voltage electrical current to the nervous system through electrodes placed on the skin. The pain-relieving effect of TENS is explained in two ways. The first is that TENS stimulates the sensory A fibers with high frequency stimulation, and the impulses of this stimulation cover the path to the brain and close the door to the passage of pain. Secondly, it affects the perception of pain by initiating the release of natural opioids in the body. It is widely used in acute and chronic pain. TENS is an analgesia method requested by the specialist doctor. How TENS will be applied to which patient, its parameters, application area and duration are determined by the doctor, and it requires the cooperation of a nurse trained in TENS (from a physiotherapy or algology specialist in TENS application) and the doctor. Many studies in this field show that TENS reduces pain. Although there are many evidence-based studies in the literature on pharmacological methods that reduce pain in TRUSG-PBx, the number of studies on non-pharmacological methods is quite limited. Our clinical examinations show that non-pharmacological methods are used very rarely in TRUSG-PBx, there is no protocol to reduce pain during and after biopsy, and nurses do not apply TENS. Additionally, no studies have been found in the literature regarding the effect of TENS application on pain, complications and comfort during and after TRUSG-PBx. This study will guide nurses in using and developing non-pharmacological methods in clinics, choosing the appropriate ones for patients with their positive and negative aspects, evaluating their effectiveness, contributing to the professional and independent roles of the nursing profession, increasing the quality of care and providing comfort and satisfaction, thereby increasing the feeling of professional satisfaction. It is thought that it will increase. In addition, it will contribute to the effective application of TENS, which is a simple, cheap and effective method that nurses, who are responsible for patient follow-up and treatment, provide direction and provide uninterrupted health services, have the authority to apply together with the physician, and will guide the development of non-pharmacological analgesia applications. It is thought that nonpharmacological methods will improve patient outcomes in the control of procedural pain resulting from diagnostic interventions. Purpose of the research: This study was conducted to determine the effect of TENS on pain, comfort level and complications in patients who underwent transrectal ultrasound-guided prostate biopsy. ### Conditions Module **Conditions:** - Prostate Cancer XXX **Keywords:** - Transcutaneous Electrical Nerve Stimulation (TENS) ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This study was conducted as a two-group randomized controlled intervention study to determine the effect of TENS application on pain, complications and comfort in patients undergoing transrectal ultrasound-guided prostate biopsy (TRUSG-PBx). ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 80 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In TENS group patients, 4 electrodes of the TENS device (2 on the front side: on the anterior right and left groin skin, 2 on the back side: on the right and left presacral skin) were placed 3-5 minutes before the biopsy procedure, and the application was started and TENS was applied throughout the procedure. continued. TENS was applied again for 30 minutes 2 hours after the procedure. Frequency of the TENS program applied in the conventional model: 100 Hz; pulse width: 150 μs; duration:30 minutes; The current intensity (amplitude: highest level 60 mA) is adjusted (according to individual tolerance by asking the patient) to create a tingling or pricking sensation that does not disturb the patient.Data were collected in three stages. **Intervention Names:** - Other: Transcuten Electriacal Nerve Stimulation **Label:** TENS **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** TENS application was not performed. Data were collected in three stages. The first (before biopsy) and second (during and after biopsy) stages were carried out face to face, and the third stage (after discharge) was conducted by telephone interview technique. Research data; The data were collected by the researcher using face-to-face and telephone interview techniques using the "Personal Information Form", "Pain Evaluation Form", "TRUSG-PBx Complication Monitoring Form" and "Perianesthesia Comfort Scale", which evaluate the personal and disease-related characteristics of the patients. **Label:** CONTROL **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - TENS **Description:** In TENS group patients, 4 electrodes of the TENS device were placed 3-5 minutes before the biopsy procedure, and the application was started and TENS was applied throughout the procedure. continued. TENS was applied again for 30 minutes 2 hours after the procedure. **Name:** Transcuten Electriacal Nerve Stimulation **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** The scale consists of 24 items and questions the individual's feelings, thoughts and feelings before and after the surgical procedure. Each item in the scale is a Likert type with a score ranging from 1 to 6 points, from "strongly disagree" to "strongly agree". It consists of positive and negative substances. 12 of the items are positive and 12 are negative.Negative statements are reversed when scoring.Accordingly, in positive items, a high score (6) indicates high comfort, a low score (1) indicates low comfort, and in negative items, a low score (1) indicates high comfort and a high score (6) indicates low comfort. In the evaluation of the scale; The resulting negative scores are reverse coded and summed with positive scores. The highest score that can be obtained from the scale is 144 and the lowest score is 24. As a result, as the score increases, comfort increases. **Measure:** Comfort (Perianesthesia Comfort Scale (PCS) **Time Frame:** Comparison of patients' Perianesthesia Comfort Scale (PCS) scores in the first 24 hours #### Primary Outcomes **Description:** The scale used in the first part of this form, which is intended to evaluate pain severity, is the Numerical Pain Scale (NPS). On this scale, it starts with absence of pain (0) and reaches the level of unbearable pain (10).According to the determined measurement times of the patients \[T1: At the beginning of the biopsy/while the ultrasound probe is being placed (NPS-1), T2: During the biopsy/5 minutes after the ultrasound probe is placed (NPS-2), T3: At the end of the biopsy/while the ultrasound probe is being removed (NPS-3). , T4: 1 hour after the end of the biopsy (NPS-4), T5: 2 hours after the end of the biopsy (NPS-5), T6: 2.5 hours after the end of the biopsy (NPS-6), T7: During the first urination after the biopsy (NPS-6). -7), T8: 6 hours after the end of the biopsy (NPS-8), T9: 24 hours after the end of the biopsy (NPS-9)\]. The second part of the pain evaluation form includes information about the analgesic medication used in the first 6 and 24 hours. **Measure:** Pain Scale (Numerical pain scale) **Time Frame:** The first 24 hours: NPS 1, 2, 3, 4, 5, 6, 7, 8, 9 #### Secondary Outcomes **Description:** Comparison of complications of patients according to time Prepared by the researchers in line with the literature, the first part of TKIF, prepared by the researchers in line with the literature, aims to determine bleeding during biopsy (rectal bleeding, bleeding from the urethra) and bleeding in the first urine after biopsy, and the second part / after discharge (at home) aims to determine complications that may develop after biopsy. 6 items are included (hematuria, hematospermia, rectal bleeding, dysuria, anal pain, urinary retention). **Measure:** Complication (TRUSG-PBx Complication Monitoring Form) **Time Frame:** Hematuria, hematospermia, rectal bleeding, urinary retention, dysuria, anal pain seen in the first 24 hours and 1 week ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * • Able to communicate, * Those who are over 40 years old, * Being literate, * No previous history of chronic pain, * Not addicted to alcohol or drugs, * Without bleeding diathesis and active urinary tract infection, * Having no cognitive impairment, neurological or psychiatric disease, * Do not have any inflammatory rheumatological, neurological or cognitive disease, * No contraindications for electrotherapy (pacemaker, arrhythmia, epilepsy, dermatological diseases), * Not using chronic opioids, antidepressants or psychoactive drugs, * Those who have not had TENS application before, * No skin lesions in the electrode connection areas, * No significant anorectal disease (wound, fistula, fissure, hemorrhoids, etc.), * As a result of the evaluation by the physician, there is no harm in applying TENS, * Patients who voluntarily agreed to participate in the research were included. Exclusion Criteria: * Lidocaine gel was applied to the anal area and rectum before the biopsy, or a different anesthetic method was used (IV, IM, rectal anesthetic/analgesic drug application or general anesthesia, etc.), * Coming for prostate biopsy followed by Foley catheter, * Patients who did not agree to participate in the research were not included in the sample. **Gender Based:** True **Gender Description:** prostate **Healthy Volunteers:** True **Minimum Age:** 40 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Adana **Country:** Turkey **Facility:** Cukurova University **State:** Sariçam **Zip:** 01330 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005834 - Term: Genital Neoplasms, Male - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000005832 - Term: Genital Diseases, Male - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000011469 - Term: Prostatic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M14335 - Name: Prostatic Neoplasms - Relevance: HIGH - As Found: Prostate Cancer - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M8946 - Name: Genital Neoplasms, Male - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M8944 - Name: Genital Diseases, Male - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14333 - Name: Prostatic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011471 - Term: Prostatic Neoplasms ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414408 **Acronym:** DOT-Doxy-PEP **Brief Title:** Randomized Directly Observed Therapy Study to Interpret Clinical Trials of Doxy-PEP **Official Title:** Randomized Directly Observed Therapy Study to Interpret Clinical Trials of Doxy-PEP #### Organization Study ID Info **ID:** AI186641 #### Organization **Class:** OTHER **Full Name:** University of California, San Francisco ### Status Module #### Completion Date **Date:** 2028-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of California, San Francisco #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Rates of bacterial sexually transmitted infections (STIs) are rising globally, demanding innovative interventions beyond the scope of current efforts to prevent STIs. The United States Doxycycline Post-exposure Prophylaxis (DoxyPEP) Study has demonstrated the efficacy of doxycycline post-exposure prophylaxis (PEP) among men who have sex with men and transgender women; but puzzlingly, doxycycline PEP was found ineffective in cisgender women in the Kenyan doxycycline Post-Exposure Prophylaxis (dPEP) study, with preliminary data suggesting the low medication adherence may explain the null result. By study end, the investigators will have developed adherence measurement methods for doxycycline in hair, blood, and urine, and will use these techniques to help interpret the Kenyan dPEP study, and to examine the relative performance of these methods within the United States DoxyPEP trial, establishing adherence metrics for current and future rollout studies of doxycycline post-exposure prophylaxis ### Conditions Module **Conditions:** - Sexually Transmitted Diseases, Bacterial ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** Participants will be randomized to one of 4 doxycycline dosing patterns (daily, 3x weekly, weekly, every other week) and then will crossover to an alternate pattern once during the study. ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 48 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will be randomized to take once daily doxycycline 200mg for six weeks. **Intervention Names:** - Drug: Doxycycline Pill **Label:** Daily Dosing **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Participants will be randomized to take one doxycycline 200mg dose three times a week (Monday, Wednesday, and Friday) for six weeks. **Intervention Names:** - Drug: Doxycycline Pill **Label:** Three-times Weekly Dosing **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Participants will be randomized to take one doxycycline 200mg dose once week. **Intervention Names:** - Drug: Doxycycline Pill **Label:** Weekly Dosing **Type:** ACTIVE_COMPARATOR #### Arm Group 4 **Description:** Participants will be randomized to take one doxycycline 200mg dose every other week. **Intervention Names:** - Drug: Doxycycline Pill **Label:** Every Other Week Dosing **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Daily Dosing - Every Other Week Dosing - Three-times Weekly Dosing - Weekly Dosing **Description:** 200mg Dose **Name:** Doxycycline Pill **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Doxycycline concentrations will be measured using liquid chromatography tandem mass spectrometry within hair samples for each of the four dosing patterns within an intensive washout pharmacokinetic phase following initial dosing. **Measure:** Hair Doxycycline Concentration **Time Frame:** 4 weeks **Description:** Doxycycline concentrations will be measured using liquid chromatography tandem mass spectrometry within plasma samples for each of the four dosing patterns within an intensive washout pharmacokinetic phase following initial dosing. **Measure:** Plasma Doxycycline Concentration **Time Frame:** 4 weeks **Description:** Doxycycline concentrations will be measured using liquid chromatography tandem mass spectrometry within urine samples for each of the four dosing patterns within an intensive washout pharmacokinetic phase following initial dosing. **Measure:** Urine Doxycycline Concentration **Time Frame:** 4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * not currently at risk of a sexually transmitted infection (no STI in the last 2 years and no partner with an STI in the last year); * willing to provide hair, blood, and urine samples; * not currently enrolled in other STI prevention studies; * able to speak English or Spanish; and * transgender women participants should be currently using estrogen gender affirming hormone therapy with blood estrogen levels demonstrating consistent use * transgender men participants should be currently using testosterone gender affirming hormone therapy with blood testosterone levels demonstrating consistent use Exclusion Criteria: * any health condition that may interfere with participation or the ability to provide informed consent, including any debilitating or life-threatening conditions; * pregnancy or plans to become pregnant; * liver cirrhosis or fulminant liver disease; * known hypersensitivity reaction to doxycycline. * detectable doxycycline in hair at enrollment. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** DOTDoxyPEP@ucsf.edu **Name:** Kevin Sassaman **Phone:** 415-878-6384 **Role:** CONTACT #### Locations **Location 1:** **City:** San Francisco **Country:** United States **Facility:** University of California, San Francisco/San Francisco General Hospital **State:** California **Zip:** 94110 #### Overall Officials **Official 1:** **Affiliation:** University of California, San Francisco **Name:** Matthew Spinelli, MD, MAS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003141 - Term: Communicable Diseases - ID: D000007239 - Term: Infections - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000001424 - Term: Bacterial Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M15558 - Name: Sexually Transmitted Diseases - Relevance: HIGH - As Found: Sexually Transmitted Diseases - ID: M17935 - Name: Sexually Transmitted Diseases, Bacterial - Relevance: HIGH - As Found: Sexually Transmitted Diseases, Bacterial - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012749 - Term: Sexually Transmitted Diseases - ID: D000015231 - Term: Sexually Transmitted Diseases, Bacterial ### Intervention Browse Module - Ancestors - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000000962 - Term: Antimalarials - ID: D000000981 - Term: Antiprotozoal Agents - ID: D000000977 - Term: Antiparasitic Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M7493 - Name: Doxycycline - Relevance: HIGH - As Found: Open-Label Study - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M4280 - Name: Antimalarials - 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 ### Intervention Browse Module - Meshes - ID: D000004318 - Term: Doxycycline ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414395 **Brief Title:** The Effects of Different Loading Doses of Dexmedetomidine on The Bispectral Index-Guided Propofol Sedation in Patients Undergoing Advanced Upper Gastrointestinal Endoscopic Procedures: A Randomized Control Study **Official Title:** The Effects of Different Loading Doses of Dexmedetomidine on The Bispectral Index-Guided Propofol Sedation in Patients Undergoing Advanced Upper Gastrointestinal Endoscopic Procedures: A Randomized Control Study #### Organization Study ID Info **ID:** PT (704) #### Organization **Class:** OTHER **Full Name:** Theodor Bilharz Research Institute ### Status Module #### Completion Date **Date:** 2024-10-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-10-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Theodor Bilharz Research Institute #### Responsible Party **Investigator Affiliation:** Theodor Bilharz Research Institute **Investigator Full Name:** Sameh Mohamed Elaidy **Investigator Title:** Assistant lecturer **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** Propofol is currently the most common drug used but has drawbacks like narrow therapeutic window and potential complications. Dexmedetomidine is an attractive alternative due to its unique properties like minimal respiratory depression. Studies are ongoing to find the optimal use of dexmedetomidine for these procedures. A combination of propofol and dexmedetomidine might be ideal, but the best balance between the two drugs needs further investigation. **Detailed Description:** Advanced upper gastrointestinal tract procedures such as Endoscopic retrograde cholangiopancreatography (ERCP) \& Endoscopic ultrasound (EUS) are very important diagnostic and therapeutic procedures for the diagnosis \& management of many pancreatobiliary pathologies whether benign or malignant (1-4). These procedures require moderate-deep sedation with the patient lying in the lateral or semi-prone position to provide the operator easier access \& insertion while permitting fluoroscopic visualisation (1-4). Propofol sedation is currently the most popular drug used for advanced endoscopic procedures because of its shorter half-life which results in a shorter recovery time than conventional sedation (benzodiazepine \&/or opioid) (5). Propofol was administered initially by intermittent boluses but later on was superseded by continuous infusion guided by clinical scoring, e.g., Ramsey sedation score (6), by target-controlled infusion (TCI) (7) or more recently by bispectral index (BIS) monitoring (8). Propofol, however, has a narrow therapeutic window that may cause fluctuation of the level of sedation from moderately deep sedation to near general anesthesia. Not only that but also propofol sedation is associated with many other complications including apnoea, airway obstruction desaturation, hypotension, bradycardia, gagging, restlessness, regurgitation \& vomiting \& delayed recovery (9). Dexmedetomidine, a highly specific, potent and selective α2-adrenoceptor agonist, was originally introduced as a sedative for critically ill mechanically ventilated patients \[9\]. In addition to sedation, it has a group of unique properties in the form of analgesia, reduction of sympathetic tone and attenuation of the neuroendocrine and hemodynamic responses to anesthesia and surgery with minimal respiratory depression, making it an attractive agent for perioperative sedation especially in remote areas outside the operating theatres (6,10). The quest to replace propofol coupled with the unique sedo-analgesic properties of dexmedetomidine resulted in the interest in the use of dexmedetomidine for providing sedation for advanced endoscopic procedure (6,10). In 2021, Srivastava et al (6), studied the effects dexmedetomidine as a sole sedative agent in the form of a loading dose of 1 µg.kg-1 followed by 0.5 µg.kg-1.hr-1 continuous infusion. They reported that although this dexmedetomidine regimen produced adequate sedation in many patients yet it was associated with a relatively high sedation failure rate requiring rescue propofol boluses (6). Moreover, dexmedetomidine was associated with bradycardia \& hypotension (6,7,11). It was 2013, When Wang et al (12), examined the propofol sparing effect of various dexmedetomidine loading doses ranging between 0.25 \& 1 µg.kg-1 followed by a fixed infusion of 0.5 µg.kg-1.hr-1 and reported a dose dependent reduction of propofol requirements for induction of sedation (12). However, they did not investigate the impact of these dexmedetomidine doses on the total propofol consumption for the whole procedure, the incidence of adverse events or the recovery profile of such a combination in the context of sedation for advanced endoscopic procedures. Thus, the" sweet spot" (13), where there is a maximal synergism between propofol and dexmedetomidine, is still to be identified. ### Conditions Module **Conditions:** - GIT Endoscopy - Procedural Sedation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This study hypothesizes that lower doses of dexmedetomidine (0.25 µg.kg-1 or the 0.5 µg.kg-1) can co-produce adequate propofol sparing sedation that is not inferior to the standard dose of 1µg.kg-1 and without significantly prolonging the propofol recovery time or increasing the total propofol consumption. ##### Masking Info **Masking:** TRIPLE **Masking Description:** Randomization will be performed using computer generated numbers with Random Allocation Software in a 1:1:1:1 ratio. The patient's allocation and drug administration instructions will be kept in consequentially numbered opaque envelopes (equal number per each group). A colleague, not participating to the study, will be responsible for study drugs preparation \& labelling. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 52 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** D1 group will receive 1µg.kg as a loading dose over 10 minutes, followed by maintenance 0.5 µg.kg. **Intervention Names:** - Drug: Precedex (Dexmedetomidine) 200 MCG in 2 ML Injection **Label:** The Dexmedetomidine Group D1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** D 0.5 group will receive 0.5 µg.kg as a loading dose over 10 minutes, followed by maintenance 0.5 µg.kg **Intervention Names:** - Drug: Precedex (Dexmedetomidine) 200 MCG in 2 ML Injection **Label:** The Dexmedetomidine Group D 0.5 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** D 0.25 group will receive 0.25 µg.kg as a loading dose over 10 minutes, followed by maintenance 0.5 µg.kg **Intervention Names:** - Drug: Precedex (Dexmedetomidine) 200 MCG in 2 ML Injection **Label:** The Dexmedetomidine Group D0.25 **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** D 0 group will receive a placebo saline infusion over 10 minutes and then will receive 50 ml of normal saline as a placebo **Intervention Names:** - Other: C group: Patients received saline infusion over 10 minutes **Label:** The Dexmedetomidine Group D 0 **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - The Dexmedetomidine Group D 0.5 - The Dexmedetomidine Group D0.25 - The Dexmedetomidine Group D1 **Description:** The Effects of Different Loading Doses of Dexmedetomidine on The Bispectral Index-Guided Propofol Sedation in Patients Undergoing Advanced Upper Gastrointestinal Endoscopic Procedures: A Randomized Control Study **Name:** Precedex (Dexmedetomidine) 200 MCG in 2 ML Injection **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - The Dexmedetomidine Group D 0 **Description:** the group will receive normal saline infusion over 10 minutes. **Name:** C group: Patients received saline infusion over 10 minutes **Other Names:** - Placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** • Recovery time of each group: the time from ending the infusions till a modified Aldrete score (MAS) score of ≥ 9 is reached. **Time Frame:** 4 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients aged 18-65 * Both sexes * ASA I-II * BMI \<35 Exclusion Criteria: * Patients' refusal to participate * ASA III-IV * BMI \> 35 * Patients who are considered high aspiration risk, e.g., gastric outlet obstruction * Allergy to any medications used * Diabetics * Any patient receiving cardioactive drugs, e.g., Beta blockers, Calcium channel blockers, Inhaled B2 bronchodilators) * Patients with Pacemakers or heart rate below 50 beat/min * Pregnant women * Habitual Drug abusers * Patients who had to be intubated during the procedure. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** sameh.elaidy@hotmail.com **Name:** Sameh M. Elaidy, Msc. **Phone:** 1111776906 **Phone Ext:** +20 **Role:** CONTACT **Contact 2:** **Email:** n.kamal21@hotmail.com **Name:** Nabawya Kamel, Proffessor **Phone:** 1066175989 **Phone Ext:** +20 **Role:** CONTACT #### Locations **Location 1:** **City:** Cairo **Contacts:** ***Contact 1:*** - **Email:** sanaabotros113@gmail.com - **Name:** Sanaa Botros, Professor - **Phone:** 1008009411 - **Phone Ext:** +20 - **Role:** CONTACT **Country:** Egypt **Facility:** Theodor Bilharz Research Institute **State:** Giza **Status:** RECRUITING **Zip:** 12411 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000006993 - Term: Hypnotics and Sedatives - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018712 - Term: Analgesics, Non-Narcotic - ID: D000000700 - Term: Analgesics - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000058647 - Term: Adrenergic alpha-2 Receptor Agonists - 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 ### 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: M22662 - Name: Dexmedetomidine - Relevance: HIGH - As Found: Twice daily - ID: M18307 - Name: Propofol - Relevance: LOW - As Found: Unknown - ID: M10043 - Name: Hypnotics and Sedatives - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M20786 - Name: Analgesics, Non-Narcotic - Relevance: LOW - As Found: Unknown - ID: 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 ### Intervention Browse Module - Meshes - ID: D000020927 - Term: Dexmedetomidine ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414382 **Acronym:** PSODEEP2PIL **Brief Title:** PSODEEP2 Pilot Study on Koebner Induction in Psoriasis **Official Title:** Pilot Study on Koebner Induction in Patients With Plaque Psoriasis #### Organization Study ID Info **ID:** PSODEEP2PIL #### Organization **Class:** OTHER **Full Name:** Skane University Hospital ### Status Module #### Completion Date **Date:** 2025-03-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Copenhagen **Class:** OTHER **Name:** Lund University #### Lead Sponsor **Class:** OTHER **Name:** Skane University Hospital #### Responsible Party **Investigator Affiliation:** Skane University Hospital **Investigator Full Name:** Albert Duvetorp **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Patients (n=15) with skin psoriasis, minimum age 18 years, without systemic immunomodulatory treatment will be subject to Koebner induction on arms and legs given that they have given written consent and that they have self-reported Koebner. **Detailed Description:** PSODEEP2 PILOT STUDY Study subject recruitation: Individuals fulfilling inclusion and exclusion criteria will be identified and contacted from the PSODEEP1 study (ethical application2023-00571-02 and 2022-02835-01), advert in social media, advert in newsletter/magazine sent out by patients organizations (Ung med Psoriasis or Psoriasisförbundet) or through direct contact with patients visits in dermatology department (n = 15). Inclusion criteria: Psoriasis skin disease. Self-reported experience of Koebner phenomena. Age 18 years or older. Ability to comprehend study information. Signed and dated informed consent. Exclusion criteria: Ongoing or planned systemic immunomodulatory treatment. Ongoing or planned narrowband UVB or PUVA treatment. Lack of suitable non-lesional skin on proximal arm or thigh due to extensive psoriatic disease. Intervention: Non-lesional skin 22mm in diameter on proximal arm or thigh at least 5 cm from the closest psoriasis lesion will be identified and marked bilaterally using a surgical skin marker. The skin sites will be documented using digital photography and the photos will be stored in REDCap (project-redcap.org). Tape will be attached and removed from the skin 40 times at all 4 sites using D-squame 22mm sampling discs and D-squame pressure applicator. Tapes are to be removed using tweezers by research staff wearing nitrile/vinyl gloves and moved to D- squame Disc Carrier which are coded/labelled so that each sampling disc has a unique code. The codes are transferred to REDCap together with study subjects background information. Tapes are transferred to -70 storage in labelled cryotubes (stored one disc per tube) prior to proteomic analysis. Taped stripped skin on left arm and left thigh is then stimulated with microneedle device (Dermapen 4) set at 0,8 mm. Study subjects are asked to contact the research group if or when psoriasis develop at any of the four stimulated sites. Study subjects will be instructed to inspect skin once daily at a minimum. If uncertainty arises as to whether psoriasis has developed it will be possible to book an appointment for skin evaluation. If psoriasis develops a second appointment will be booked. At the second appointment all 4 locations will be documented using digital photography (and stored in REDCap). Locations will be re-sampled using 10 D- squame 22mm sampling discs per location. At locations showing signs of psoriasis development, induration, erythema and scaling will be assessed and recorded in REDCap (0- 4 points). In local anesthesia, a 4mm punch biopsy will be performed from developed psoriasis lesions (K+) (Koebner positive) and put in Eppendorf tube before being frozen on dry ice, labelled with unique code and transferred to - 70 freezer before further analysis. If no psoriasis develops then the study subjects will be booked for appointment 2 approximately day 21 after Koebner induction. For these subjects stratum corneum skin sampling will be performed at all four sites using 10 D-squame 2mm sampling discs transferred to D-squame Disc Carrier and then to cryotubes for storage at - 70 °C. Bioanalysis: For proteomic analysis, proteins will be lysed directly on the tape strips and prepared according to previously described protocol after which liquid chromatography-mass spectrometry will be performed (21). Punch biopsies from developing or early psoriasis lesions will be analyzed accordingly to validate psoriasis development including histological assessment of signs of psoriasis (parakeratosis, psoriasiform hyperplasia, epidermal neutrophilic infiltration, dilated vessels in papillary dermis, loss of stratum granulosum). Additionally modern techniques analyzing the transcriptome, proteome and epigenome will be used to assess psoriasis development. Study significance: The PILOT study aims to answer research questions: * Will the addition of micro-needling to tape-stripping increase Koebner reactivity in non-lesional psoriasis skin? * Does Koebner-reactivity differ between proximal arm and proximal leg? The answer to these questions are essential to determine the optimal intervention of the main study. The method and location that results in the higher proportion of Koebner positive reactions will be selected for the main study. It will also provide preliminary proteomic data which can facilitate a more accurate sample size calculation for main study. ### Conditions Module **Conditions:** - Psoriasis Vulgaris - Koebner Phenomenon ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Koebner phenomena will be induced using tape-stripping or tape-stripping and micro needling. Koebner development will be assessed. ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 15 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Koebner will be induced on area 22mm in diameter on upper bilateral arms and anterior bilateral thighs. **Intervention Names:** - Other: Tape-stripping **Label:** Koebner induction **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Koebner induction **Description:** 22mm tapes x 40 will be attached and removed to skin of all for limbs (tape stripping). On left arm and leg skin will also be subject to micro needling. **Name:** Tape-stripping **Other Names:** - Micro-needling **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Psoriasis lesion develops at site of provocation/induction **Measure:** Positive Koebner Phenomena (K+) **Time Frame:** 7-21 days after induction **Description:** No psoriasis lesion develops at site of provocation/induction **Measure:** Negative Koebner Phenomena (K-) **Time Frame:** 21 days after induction #### Secondary Outcomes **Description:** Mass spectrometry of stratum corneum at koebner induction sites **Measure:** Stratum corneum proteomics **Time Frame:** At baseline and at time of K+ assessment or day 21 if K- ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Self reported Koebner * Diagnosis of skin psoriasis Exclusion Criteria: * Systemic immunomodulatory treatment (including narrowband UVB) **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** albert.duvetorp@skane.se **Name:** Albert Duvetorp, PhD MD **Phone:** +460736166946 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Copenhagen University SIC, Karolinska Institutet **Name:** Liv Eidsmo, Professor **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** This is a pilot study necessary for selection of suitable method in subsequent follow up study. Data sharing outside research group has not been part of the ethical approval´s description of data handling. These two reasons are behind the "no". **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000017444 - Term: Skin Diseases, Papulosquamous - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14422 - Name: Psoriasis - Relevance: HIGH - As Found: Psoriasis - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M19713 - Name: Skin Diseases, Papulosquamous - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011565 - Term: Psoriasis ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414369 **Acronym:** FIBDIAT **Brief Title:** Effects of Diatermy in Patients With Fibromyalgia. **Official Title:** Effects of Diatermy in Patients With Fibromyalgia. #### Organization Study ID Info **ID:** CamiloJDF #### Organization **Class:** OTHER **Full Name:** Camilo Jose Cela University ### Status Module #### Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Camilo Jose Cela University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Diathermy is a non-invasive pain therapy based on the local application of high-frequency electromagnetic waves. This procedure produces deep heat promotes tissue repair and influences pain sensitivity. The main characteristic of fibromyalgia (FM) is generalized musculoskeletal pain. This may be accompanied by muscle and joint stiffness, sleep and mood disorders, anxiety and depression, cognitive dysfunction, and chronic fatigue. Endemic in developed countries, with a higher prevalence among women than men, and the etiology is still unknown. Diagnosis is made on chronic generalized pain and through the presence of tender points. The objective of this study will be to analyze the efficacy of diathermy on pain in patients with fibromyalgia **Detailed Description:** The researchers aimed will be to observe the effect of diathermy (DT) on chronic fatigue, anxiety, and depression; analyze whether there are improvements in the impact of the disease in patients with FM after the application of DT; and check if there is an improvement in the quality of sleep after the application of DT. The aim is to collect a sample of more than 30 patients with fibromyalgia. Variables to be collected include the overall pain experienced by the patients (Visual Analog Scale), Presure Pain Threshold using an algometer of the right and left trochanteric prominence, the Fibromyalgia Impact Questionnaire (FIQ) measures the impact of FM, the Hospital Anxiety and Depression Scale (HADS) to measure anxiety and depression, the Pittsburgh Sleep Quality Questionnaire (PSQI) to measure sleep quality and the modified Fatigue Impact Scale (MFI-S) to measure self-reported general fatigue. Subjects will be randomized into two groups: a control group (CG) that will not recive treatment and a experimental group (EU). ### Conditions Module **Conditions:** - Fibromyalgia **Keywords:** - fibromyalgia - diathermy - pain - quality of life - chronic fatigue - 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:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This group will receive eight sessions of 20 minutes, for four weeks, twice a week. **Intervention Names:** - Other: Diathermy **Label:** Experimental group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The treatment will be simulated during eight sessions of 20 minutes (machine will be off), for four weeks, twice a week. **Intervention Names:** - Other: Simulated Diathermy **Label:** Control group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental group **Description:** A DT equipment (CET 400 VA - RET 130 Watts - Winback, France), with a frequency of 500 kHz and intensity at 40% will be used. It will be applied utilizing a flat capacitive head 4 cm in diameter. It will be applied using longitudinal and transverse movements and a conductive cream for DT. DT will be used over the TP of the right and left trochanteric prominence. The settings will be calibrated so that patients fell no more than mild warmth during the treatment. **Name:** Diathermy **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Control group **Description:** This same intervention that has been given to the experimental group, will be simulated as placebo in the control group; the DT will not be activated during administration. **Name:** Simulated Diathermy **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** visal analogue scale, on a scale of 1-10, with higher scores indicating more pain. **Measure:** Pain (VAS) **Time Frame:** base line; after finish the treatment (4 weeks) and 15 days after completing treatment. **Description:** Algometer, on a scale of 0-5. with higher scores indicating less pain. **Measure:** Pain (algometry) **Time Frame:** base line; after finish the treatment (4 weeks) and 15 days after completing treatment. #### Secondary Outcomes **Description:** The Fibromyalgia Impact Questionnaire (FIQ) measures the impact of FM. The values range between 0 and 100, with a higher score indicating a greater impact of the disease. **Measure:** The impact of fibromyalgia. **Time Frame:** base line; after finish the treatment (4 weeks) and 15 days after completing treatment. **Description:** The Hospital Anxiety and Depression Scale (HADS) questionnaire, that consists of 14 items, divided into two subscales with 7 items each, using a Likert scale from 0 to 3. The odd-numbered items pertain to HADA, and the even-numbered ones relate to HADD. Each scale has a score range of 0-21 points. Higher scores indicate higher levels of anxiety and depression. Scores exceding 11 are classified as "cases," while those surpassing 8 are regarded as "probable cases" of anxiety and depression **Measure:** anxiety and depression **Time Frame:** base line; after finish the treatment (4 weeks) and 15 days after completing treatment. **Description:** The Pittsburgh Sleep Quality Questionnaire (PSQI)assesses seven dimensions: sleep quality, delay in falling asleep, duration of sleep, perceived effectiveness of sleep, disturbances during sleep, use of medication for sleeping, and daytime dysfunction. Each aspect is assigned a score from 0 to 3. Lower scores indicate no challenges in the specific areas while higher scores up to 3 indicate severe difficulties. The maximum achievable total score is 21 denoting critical sleep issues. A higher point total corresponds to a greater severity of sleep disorders. **Measure:** sleep quality **Time Frame:** base line; after finish the treatment (4 weeks) and 15 days after completing treatment. **Description:** The modified Fatigue Impact Scale (MFI-S) with a a higher score that indicates a more severe condition. **Measure:** self-reported general fatigue **Time Frame:** base line; after finish the treatment (4 weeks) and 15 days after completing treatment. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Experience chronic generalized pain and be diagnosed with FM for at least three months Exclusion Criteria: * Recent surgery, skin conditions unsuitable for DT application, presence of certain neuropathic conditions (lupus, rheumatoid arthritis, diabetic polyneuropathy), ongoing pharmacological treatment such as anticoagulants within three days before participation, any underlying medical conditions like fractures or tumors; cardiac pathologies including heart failure, uncontrolled arterial hypertension, arrhythmias, phlebitis thrombi arteriopathies; having a pacemaker or suffering from epilepsy. **Maximum Age:** 70 Years **Minimum Age:** 30 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** eubeda@ucjc.edu **Name:** Edurne Ú Docasar **Phone:** +34918153131 **Role:** CONTACT **Contact 2:** **Name:** Edurne Ú Docasar **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** University Camilo José Cela **Name:** Edurne Ú Docasar **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M8364 - Name: Fatigue - Relevance: LOW - As Found: Unknown - ID: M2454 - Name: Hyperthermia - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M8486 - Name: Fibromyalgia - Relevance: HIGH - As Found: Fibromyalgia - ID: M12161 - Name: Myofascial Pain Syndromes - Relevance: HIGH - As Found: Fibromyalgia - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005356 - Term: Fibromyalgia - ID: D000009209 - Term: Myofascial Pain Syndromes ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414356 **Brief Title:** The Effect of Outpatient Ketamine Infusion on Chronic Neuropathic Pain and PTSD **Official Title:** The Effect of Outpatient Ketamine Infusion on Chronic Neuropathic Pain and PTSD: A Prospective Randomized Design #### Organization Study ID Info **ID:** 954942 #### Organization **Class:** FED **Full Name:** Brooke Army Medical Center ### Status Module #### Completion Date **Date:** 2027-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-04-29 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** FED **Name:** Margaux M. Salas, PhD #### Responsible Party **Investigator Affiliation:** Brooke Army Medical Center **Investigator Full Name:** Margaux M. Salas, PhD **Investigator Title:** Senior Scientist Expert **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is aimed to evaluate outpatient ketamine infusion within a military chronic neuropathic pain population and its effect on PTSD. Currently, this is a pilot study with 30 participants. Participants will be randomized to (1) a moderate dose ketamine, (2) moderate dose ketamine +Mg, or (3) a magnesium control group. Participants will complete self-reported pain and PTSD questionnaires throughout the \~24-week study period. The outlined strategy will provide evidence for the utility of ketamine in neuropathic pain management and pain associated comorbidities within a military population. **Detailed Description:** Subjects will be recruited with no target toward ethnicity, gender, or race. Active duty, veteran, retiree, and military dependents between the ages of 18-70 years old with an established diagnosis of chronic neuropathic pain will be identified and screened for study inclusion. Enrollees will have had neuropathic pain \>3 months duration, report a pain score between 4-7, and meet inclusion/exclusion criteria for the study. Since ketamine's influence on PTSD is a secondary measure, any patients with a PCL-5 score \> 33 will be noted. After informed consent is obtained participants will be randomized into a (1) moderate dose ketamine, (2) moderate dose ketamine +Mg, or (3) a magnesium control group. The magnesium-only group will be randomly assigned to one of the treatment groups (moderate dose ketamine or moderate dose ketamine +Mg) after 2 weeks and complete the full infusion treatment regime of the randomly selected treatment group. Administration of ketamine will occur in diminishing number of dosing events: Week 1 \& 2 will consist of 3 treatments per week. Weeks 3 \& 4 will consist of 2 treatments per week. Weeks 5 \& 6 will consist of 1 treatment per week. Booster treatments will be administered week 10 and week 24. Booster treatments will only be 1 infusion that week. Participants will fill out questionnaires before and after each infusion- day concerning their pain, PTSD, anxiety, depression, and quality of life. Participants will be evaluated at least 5 days prior to the first treatment and 30-35 days after the final infusion. Participants will continue their current pain management regimen during the study and be instructed to use analgesics only as needed. Pain medication use will be recorded throughout the study. ### Conditions Module **Conditions:** - Neuropathic Pain - PTSD **Keywords:** - Ketamine Hydrochloride ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** FACTORIAL **Intervention Model Description:** (1) Moderate-dose ketamine (0.50 mg/kg/hr) (Orhurhu et al., 2019), and (2) moderate-dose ketamine in combination with magnesium (750 mg/hr) (Urits et al., 2021) and (3) magnesium control (750mg/hr) will be assessed. Of note, we are adapting a delayed control treatment group design. The control group (Mg only control) will be randomly assigned to one of the treatment groups (moderate dose ketamine, or moderate dose ketamine +Mg) after 2 weeks and complete the full infusion treatment regime of the randomly selected treatment group. ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 0.5 mg/kg/hr The total amount of ketamine for each participant is dependent on their body weight in kg per ideal body weight (IBW) formula. This total ketamine dose will be injected into one 250 ml normal saline 0.9% solution with a rate of 62.5 ml/hr over four hours or until the contents of the bag are infused and flushed with 20 ml of normal saline **Intervention Names:** - Drug: Ketamine **Label:** Moderate Dose Ketamine **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 0.50 mg/kg/hr ketamine + 750 mg/hr Mg **Intervention Names:** - Drug: Ketamine + Magnesium sulfate **Label:** Moderate dose ketamine + magnesium sulfate **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** 750 mg/hr **Intervention Names:** - Drug: Magnesium sulfate **Label:** Magnesium sulfate **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Moderate Dose Ketamine **Description:** Ketamine will be placed in 250 mL normal saline and infused at a rate of 62.5 mL/hr. Participants will receive intravenous infusions of ketamine for 4 hours each day in diminishing number of dosing events per week for the full 24-week infusion regime in an outpatient setting. (ketamine 0.5 mg/kg IBW/hr) **Name:** Ketamine **Other Names:** - Ketalar **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Magnesium sulfate **Description:** Magnesium sulfate 3 grams will be diluted into 250 mL normal saline and infused at a rate of 62.5 mL/hr (over 4 hours until the entire contents are infused and then flushed with 20 mL of normal saline). The Mg only group will be randomly assigned to one of the treatment groups (moderate dose ketamine, or moderate dose ketamine +Mg) after 2 weeks and complete the full 24-week infusion treatment regime of the randomly selected treatment group in an outpatient setting. **Name:** Magnesium sulfate **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Moderate dose ketamine + magnesium sulfate **Description:** Participants will receive intravenous infusions of ketamine and magnesium sulfate in combination. Ketamine will be placed in 250 mL normal saline and infused at a rate of 62.5 mL/hr Participants will receive intravenous infusions of ketamine and magnesium sulfate for 4 hours each day in diminishing number of dosing events per week for the full 24-week infusion regime in an outpatient setting. (Ketamine 0.5 mg/kg IBW/hr + magnesium sulfate 3 grams diluted into 250 mL normal saline) **Name:** Ketamine + Magnesium sulfate **Other Names:** - ketalar + Magnesium Sulfate **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The DVPRS is a self-report instrument used to assess pain intensity in military personnel, veterans, and other military populations. It was specifically developed for individuals with military backgrounds and is often used in clinical settings to monitor pain levels and treatment effectiveness. The DVPRS consists of a Numeric Rating Scale (NRS) from 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain." Respondents rate their pain intensity by selecting the number that best corresponds to their current level of pain. The DVPRS questionnaire will be used to determine how daily pain levels change throughout the study. Three questions assess current pain, worst pain in past 7 days, and worse pain in past month. These three questions are separately assessed for pain. **Measure:** Defense and Veterans Pain Rating Score (DVPRS) **Time Frame:** Up to 32 weeks **Description:** The BPI is a 15-item self-report measure of pain intensity and pain interference with daily life. The Brief Pain Inventory (BPI) is scored separately for its two main sections: Pain Severity and Pain Interference. It includes questions about the intensity of pain at its "worst," "least," "average," and "right now" over the past week. Respondents rate the severity of pain on a numeric rating scale (NRS) from 0 to 10. The Pain Interference section evaluates the extent to which pain interferes with various aspects of the individual's life. The Pain Severity Score is calculated with the average score of the four items assessing pain severity. This average represents the overall pain severity experienced by the individual. This questionnaire will be used to determine how current pain levels change throughout the study. **Measure:** Brief Pain Inventory Scale (BPI) **Time Frame:** Up to 32 weeks **Description:** The LiSAT is a self-report instrument used to assess overall satisfaction with various life domains. It provides a comprehensive assessment of life satisfaction. The LiSAT consists of items that assess satisfaction across several domains of life, such as: work, leisure activities and free time, economy, relationships with friends, relationships with relatives, sexual life/partner relationship, physical health, psychological health, and safety. Respondents rate their satisfaction within each domain using a Likert-type scale, with response options ranging from "very dissatisfied" to "very satisfied". Each response is assigned a numerical value. After completing the questionnaire, scores for each domain are summed or averaged to obtain a total score or subscale scores representing satisfaction within specific life domains. Higher scores indicate greater satisfaction within the respective domain. **Measure:** Life Satisfaction Questionnaire (LiSAT) **Time Frame:** Up to 32 weeks **Description:** The PTSD Checklist (PCL-5) is a widely used self-report measure used to assess symptoms of post-traumatic stress disorder (PTSD). It consists of 20 items that correspond to the Diagnostic and Statistical criteria for PTSD. Respondents rate the frequency of symptoms over the past month on a scale from 0 (Not at all) to 4 (Extremely). There are different cutoff scores used for diagnosing PTSD or assessing the severity of symptoms, but higher total scores generally indicate more severe PTSD symptoms. * 0-31: Subclinical range (minimal to no PTSD symptoms) * 32-37: Mild PTSD symptoms * 38-43: Moderate PTSD symptoms * 44 and above: Severe PTSD symptoms **Measure:** Post-traumatic Stress Disorder Checklist (PCL-5) **Time Frame:** Up to 32 weeks **Description:** The Patient-Reported Outcomes Measurement Information System (PROMIS 29+2) profile is a comprehensive assessment tool used to evaluate various aspects of health-related quality of life (HRQOL) across physical, mental, and social domains. Respondents rate their experiences over the past 7 days using a Likert-type scale, with response options ranging from 1 to 5. Higher scores indicate greater impairment or severity of symptoms, depending on the specific domain being assessed. For scoring, each item is scored based on the response provided by the respondent. Scores for items within each domain are aggregated to calculate domain scores. The questionnaire provides individual scores for each domain assessed, allowing for a comprehensive profile of the respondent's health-related quality of life. Total for each domain is assessed. Higher scores typically indicate greater impairment or symptom severity, while lower scores indicate better functioning or fewer symptoms. **Measure:** The Patient-Reported Outcomes Measurement Information System (PROMIS 29+2) **Time Frame:** Up to 32 weeks **Description:** The Patient Health Questionnaire-9 (PHQ-9) is a widely used screening tool for depression. It consists of nine questions that ask about symptoms experienced over the past two weeks. Each question is scored on a scale from 0 to 3, with responses ranging from "not at all" to "nearly every day." To score the PHQ-9: 1. Assign a score from 0 to 3 for each question based on the response: * "Not at all" = 0 * "Several days" = 1 * "More than half the days" = 2 * "Nearly every day" = 3 2. Sum the scores for all nine questions to obtain a total score, which can range from 0 to 27. Interpretation of the total PHQ-9 score is as follows: * 0-4: Minimal depression symptoms * 5-9: Mild depression symptoms * 10-14: Moderate depression symptoms * 15-19: Moderately severe depression symptoms * 20-27: Severe depression symptoms **Measure:** Patient Health Questionnaire-9 (PHQ-9) **Time Frame:** Up to 32 weeks **Description:** The Generalized Anxiety Disorder 7-item scale (GAD-7) is a widely used screening tool designed to assess the severity of generalized anxiety disorder (GAD) symptoms. It consists of seven questions that ask about symptoms experienced over the past two weeks. Each question is scored on a scale from 0 to 3, with responses ranging from "not at all" to "nearly every day." To score the GAD-7 questions are rated from 0 to 3. * "Not at all" = 0 * "Several days" = 1 * "More than half the days" = 2 * "Nearly every day" = 3 The sum of the scores for all seven questions obtain a total score, which can range from 0 to 21. Interpretation of the total GAD-7 score is as follows: * 0-4: Minimal anxiety symptoms * 5-9: Mild anxiety symptoms * 10-14: Moderate anxiety symptoms * 15-21: Severe anxiety symptoms **Measure:** Generalized Anxiety Disorder Scale **Time Frame:** Up to 32 weeks #### Secondary Outcomes **Description:** The Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) tool is a comprehensive screening instrument used to assess an individual's substance use across multiple categories. It's designed to provide a thorough evaluation of substance use behaviors, including tobacco, alcohol, prescription medications, and other substances. **Measure:** Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tool **Time Frame:** Up to 32 weeks **Description:** The Richmond Agitation-Sedation Scale (RASS) measures a patient's agitation or sedation level. The scale ranges from -5 to +4: Based on the observed behavior, assign a numerical score on the RASS scale: * +4: Combative, violent, immediate danger to staff * +3: Very agitated, pulling at tubes, aggressive * +2: Agitated, restless, anxious, attempting to sit up * +1: Restless, uneasy, fidgety, tense * 0: Alert and calm * -1: Drowsy, not fully alert but able to be aroused * -2: Light sedation, easily aroused, briefly following commands * -3: Moderate sedation, difficult to arouse but responds to stimuli * -4: Deep sedation, minimal or no response to stimuli * -5: Unarousable, no response to stimuli **Measure:** Richmond Agitation-Sedation Scale (RASS) **Time Frame:** Up to 26 weeks **Description:** The CADSS is a tool used to assess dissociative states induced by drugs or other factors. The Clinician-Administered Dissociative States Scale (CADSS) is used to measure the severity of dissociative states induced by drugs or other factors. Each item on the scale is rated on a 5-point Likert scale, ranging from 0 (not at all) to 4 (extremely). The total score is calculated by summing up the scores for all items on the scale.To score the CADSS, each item is rated on a 5-point Likert scale (0 to 4) based on the severity of the symptom described. The total score is summed for all 23 items to obtain the total CADSS score. This total score ranges from 0 to 92, with higher scores indicating greater severity of dissociative symptoms. **Measure:** Clinician-Administered Dissociative States Scale (CADSS) **Time Frame:** Up to 26 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18-70 years old with Chronic Neuropathic Pain \>= 3 months * Biologic male or biologic female * Women of childbearing age will be included if there are no plans of pregnancy within the study period, the participant agrees to actively utilize contraception throughout the study, and agrees to pregnancy tests * Active Duty, Veterans, and retirees * Ketamine naïve for 1 year * Moderate Neuropathic pain Scale 4-7 Exclusion Criteria: * Cognitive dysfunction * Psychiatric illness involving psychosis * Neurocognitive disorder * Patients with Traumatic Brain Injury (TBI) * Acute cardiovascular disease or poorly controlled hypertension * Untreated or uncontrolled thyroid disease * Hyperthyroidism * Severe liver or renal disease * Renal impairment * History of recent heart attack, vascular disease, or any other medical condition that may be deemed by a provider as a contraindication to receiving ketamine * Active substance abuse * Pregnant or lactating * Patients who are planning to become pregnant within 12 weeks of treatment completion * Elevated Blood Pressure/hypertension * Known hypersensitivity to Ketamine * Hemodynamic instability * Respiratory depression * Use of Theophylline or Aminophylline, Sympathomimetics and Vasopressin, * Use of Benzodiazepines * A history of drug abuse or dependence * Active risk of substance use * Patients who are not able to abide by the pre-treatment and posttreatment clinical protocol, such as food intake, abstaining from certain medications, unable to remain in the clinic for a minimum of 1 hour for observation, and cannot provide the name and phone number of the party who will pick them up post-treatment **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:** margaux.m.salas.ctr@health.mil **Name:** Margaux M Salas, PhD **Phone:** 210-473-7447 **Role:** CONTACT **Contact 2:** **Email:** kevin.c.peterson3.mil@health.mil **Name:** Kevin C Peterson, MD **Phone:** 210-916-7331 **Role:** CONTACT ### References Module #### References **Citation:** Urits I, Jung JW, Amgalan A, Fortier L, Anya A, Wesp B, Orhurhu V, Cornett EM, Kaye AD, Imani F, Varrassi G, Liu H, Viswanath O. Utilization of Magnesium for the Treatment of Chronic Pain. Anesth Pain Med. 2021 Feb 6;11(1):e112348. doi: 10.5812/aapm.112348. eCollection 2021 Feb. **PMID:** 34221945 **Citation:** Orhurhu V, Orhurhu MS, Bhatia A, Cohen SP. Ketamine Infusions for Chronic Pain: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Anesth Analg. 2019 Jul;129(1):241-254. doi: 10.1213/ANE.0000000000004185. **PMID:** 31082965 ## 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: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - 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: M12381 - Name: Neuralgia - Relevance: HIGH - As Found: Neuropathic Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M13432 - Name: Peripheral Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009437 - Term: Neuralgia ### Intervention Browse Module - Ancestors - ID: D000000700 - Term: Analgesics - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000778 - Term: Anesthetics, Dissociative - ID: D000018686 - Term: Anesthetics, Intravenous - ID: D000018681 - Term: Anesthetics, General - ID: D000000777 - Term: Anesthetics - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000018691 - Term: Excitatory Amino Acid Antagonists - ID: D000018683 - Term: Excitatory Amino Acid Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000889 - Term: Anti-Arrhythmia Agents - ID: D000000927 - Term: Anticonvulsants - ID: D000002121 - Term: Calcium Channel Blockers - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000077264 - Term: Calcium-Regulating Hormones and Agents - ID: D000015149 - Term: Tocolytic Agents - ID: D000012102 - Term: Reproductive Control Agents ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: ChanBlk - Name: Channel Blockers - Abbrev: AntiConv - Name: Anticonvulsants - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: BDCA - Name: Bone Density Conservation Agents ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M10674 - Name: Ketamine - Relevance: HIGH - As Found: Provided - ID: M11270 - Name: Magnesium Sulfate - Relevance: HIGH - As Found: Aerobic exercise - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4108 - Name: Anesthetics, Dissociative - Relevance: LOW - As Found: Unknown - ID: M20766 - Name: Anesthetics, Intravenous - Relevance: LOW - As Found: Unknown - ID: M20761 - Name: Anesthetics, General - Relevance: LOW - As Found: Unknown - ID: M20771 - Name: Excitatory Amino Acid 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: M4246 - Name: Anticonvulsants - Relevance: LOW - As Found: Unknown - ID: M5381 - Name: Calcium - Relevance: LOW - As Found: Unknown - ID: M5384 - Name: Calcium Channel Blockers - Relevance: LOW - As Found: Unknown - ID: M5398 - Name: Calcium, Dietary - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M17869 - Name: Tocolytic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000008278 - Term: Magnesium Sulfate - ID: D000007649 - Term: Ketamine ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414343 **Acronym:** LATENT **Brief Title:** LATe TreatmENT Related Toxicity in Melanoma (LATENT) **Official Title:** LATe TreatmENT Related Toxicity in Melanoma (LATENT) #### Organization Study ID Info **ID:** CCR6009 #### Organization **Class:** OTHER **Full Name:** Royal Marsden NHS Foundation Trust ### Status Module #### Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-04-24 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Royal Marsden NHS Foundation Trust #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Recent improvements in advanced melanoma treatment with immunotherapy have dramatically improved patient survival. Longer survival however has come at a cost of toxicity. Short term side effects can occur in \>50% of patients undergoing immunotherapy treatment; however, many long-term survivors are also living with serious consequences of these treatments which may be under reported in literature. Data regarding long term toxicities, from these treatments is lacking and an area of important unmet clinical need. Therefore, in collaboration with the Clatterbridge and Christie's teams, the investigators propose to retrospectively analyse the nature, incidence, frequency, and severity of immune related toxicities in around 400 patients who received immunotherapy for advanced melanoma with ongoing durable responses to treatment of at least 3 years. The investigators will set up a collective anonymized database and record this information through review of electronic medical records of patients that meet the eligibility criteria. The investigators will also review the patterns of use of long-term immunosuppression and assess the need for specialist referrals for managing late side effects. The investigators hope that this data will help us address gaps in the management of long-term survivors by identifying areas of need and establishing a coordinated evidence based multidisciplinary service to provide personalised, risk stratified long term follow up. **Detailed Description:** LATENT will be a retrospective non-interventional analysis of pre-existing data from patient medical records and, therefore patients will not be required to participate in any risky procedures, treatments or hospital visits. The study will therefore not require explicit informed consent from eligible participants. A potential ethical issue could arise around explicit consent of patients for collection and publication of their data. The investigators aim to circumvent this by only using data that has already been recorded from direct patient care. The investigators will pseudo-anonymise personal data and mitigate risk of identification through: 1. Direct health care providers screening for eligible patients from clinic records based on clear inclusion and exclusion criteria 2. Allocation of de-identified serial numbers for patients on the database used to collect and record relevant data 3. Exportation and storage of de-identified data from all sites on a common trusted research environment (TRE) 'BRIDGE' for blinded analysis by the Research team 4. Reporting of anonymised/de-identified data only, for publication In addition, the investigators aim to reduce selection bias by eliminating the need for explicit consent as unwell patients with greater clinical needs may be unable to consent and would not be included in the study, thereby only selecting for well patients and potentially underrepresenting a vital group of patients, compromising the scientific validity of the study. As this is a multicentre study, de-identified, anonymised data from all centres will be exported and stored in a single secure password protected TRE for analysis. The main centre in charge of maintaining and analysing the database, with appropriate data sharing agreements with individual sites, will be The Royal Marsden team. The investigators do not anticipate any legal issues arising from this study. ### Conditions Module **Conditions:** - Melanoma ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 400 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Observational - no intervention **Name:** Observational - no intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** • Descriptive analysis of proportion of patients (%) developing immune related adverse events in those with advanced melanoma with ongoing response of at least 3 years following treatment with immune checkpoint inhibitors. Description of severity of each type of toxicity and adverse events experienced in the overall population measured as Grade 1-5 as per Common Terminology Criteria for Adverse Events (CTCAE v5.0). **Measure:** To describe patterns of a range of medical late toxicities following immunotherapy treatment for advanced melanoma patients **Time Frame:** 12 months #### Secondary Outcomes **Description:** • Exploration of differences in proportions of patients developing different types and severities of late toxicities according to treatment type (single vs doublet immunotherapy), disease (stage, mutational status) and patient characteristics (eg; age, gender, smoking status, etc) using univariate and multivariate analyses. **Measure:** Exploration of differences in proportions of patients **Time Frame:** 12 months **Description:** • Time to occurrence of irAEs using Kaplan-Meier survival analysis measured in years and months. **Measure:** Time to occurrence of irAEs **Time Frame:** 12 months **Description:** • Descriptive analyses of the frequency of use of immunosuppressive agents used (%) for treating late immune toxicities for each type of agent, toxicity and duration of immunosuppressive treatment. **Measure:** Descriptive analyses of the frequency of use of immunosuppressive agents **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Histological diagnosis of melanoma * Age 18 years or older * Treated between January 2005- December 2020 with immune checkpoint inhibitor therapy including either Pembrolizumab, Nivolumab, Ipilimumab or combinations, for advanced melanoma (unresectable stage III or stage IV) * Ongoing response to therapy of at least 3 years duration at point of study entry Exclusion Criteria: * Diagnoses of other concurrent malignancies needing active treatment * Received Immune checkpoint inhibitors for non-metastatic melanoma or in the adjuvant setting only. * Received other treatments including targeted therapy as the most recent line of treatment or following immunotherapy. * Progression of disease on or following immunotherapy **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** This will be a collaborative multicentre non-interventional retrospective analysis of pre-recorded data collected from patient medical records by direct treating teams. The participants will be patients of at least age 18, treated for advanced and metastatic melanoma between 2005-2020 with immune checkpoint inhibitors and have ongoing response to treatment (either stable disease, partial or complete response per RECIST 1.1) for at least 3 years at the time of inclusion in the study. Patients with metastatic melanoma treated with immunotherapy will be identified from the electronic hospital records by treating clinical teams/research team at each centre and screened for eligibility. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** arjun.modi@rmh.nhs.uk **Name:** Arjun Modi **Phone:** 020 7352 8171 **Role:** CONTACT **Contact 2:** **Email:** sowmya.cheruvu@rmh.nhs.uk **Name:** Sowmya Cheruvu, MD **Phone:** 020 7352 8171 **Role:** CONTACT #### Locations **Location 1:** **City:** Chelsea **Contacts:** ***Contact 1:*** - **Email:** arjun.modi@rmh.nhs.uk - **Name:** Arjun Modi - **Phone:** 02073528171 - **Role:** CONTACT **Country:** United Kingdom **Facility:** Royal Marsden NHS Foundation Trust **State:** London **Zip:** SW3 6JJ #### Overall Officials **Official 1:** **Affiliation:** Royal Marsden NHS Foundation Trust **Name:** Kate Young, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000018358 - Term: Neuroendocrine Tumors - ID: D000017599 - Term: Neuroectodermal Tumors - ID: D000009373 - Term: Neoplasms, Germ Cell and Embryonal - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009380 - Term: Neoplasms, Nerve Tissue - ID: D000018326 - Term: Nevi and Melanomas - ID: D000012878 - Term: Skin Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11528 - Name: Melanoma - Relevance: HIGH - As Found: Melanoma - ID: M20495 - Name: Neuroendocrine Tumors - Relevance: LOW - As Found: Unknown - ID: M19845 - Name: Neuroectodermal Tumors - Relevance: LOW - As Found: Unknown - ID: M20388 - Name: Neuroectodermal Tumors, Primitive - Relevance: LOW - As Found: Unknown - ID: M12318 - Name: Neoplasms, Germ Cell and Embryonal - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M12325 - Name: Neoplasms, Nerve Tissue - Relevance: LOW - As Found: Unknown - ID: M12448 - Name: Nevus, Pigmented - Relevance: LOW - As Found: Unknown - ID: M12446 - Name: Nevus - Relevance: LOW - As Found: Unknown - ID: M20470 - Name: Nevi and Melanomas - Relevance: LOW - As Found: Unknown - ID: M15681 - Name: Skin Neoplasms - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: T4091 - Name: Neuroendocrine Tumor - Relevance: LOW - As Found: Unknown - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008545 - Term: Melanoma ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414330 **Acronym:** HTK **Brief Title:** Ringer Acetate Based Modified Del Nido Cardioplegia Solution Versus HTK Solution Cardioplegia Solution in Cardiac Surgery **Official Title:** Ringer Acetate Based Modified Del Nido Cardioplegia Solution Versus Histidine, Tryptophan and Ketoglutarate Solution Cardioplegia Solution in Cardiac Surgery #### Organization Study ID Info **ID:** Delnido cardioplegia #### Organization **Class:** OTHER **Full Name:** Assiut University ### Status Module #### Completion Date **Date:** 2024-11-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-10-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Ahmed Ismail Abdelsabour **Class:** UNKNOWN **Name:** Ramy Mustafa Abdelgawad Mohamed **Class:** UNKNOWN **Name:** Ibrahim Mohamed Imbaby **Class:** UNKNOWN **Name:** Amr Ibrahim Abdelaal **Class:** UNKNOWN **Name:** Mahmoud Mohamed Atef Sallam **Class:** UNKNOWN **Name:** Mohamed, Ahmed Abdelhay Mohamed #### Lead Sponsor **Class:** OTHER **Name:** Assiut University #### Responsible Party **Investigator Affiliation:** Assiut University **Investigator Full Name:** Ayman Abd El-Khalek Mohammed Glala **Investigator Title:** principal investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Low chloride solutions were proved to be better in resuscitation of emergency cases and decrease the resulting hyperchloremic metabolic acidosis in the last decade. In ringers' acetate solutions, there is acetate, which is metabolized in muscles to produce bicarbonate molecules, so neutralizing the ongoing lactic and hyperchloremic metabolic solutions. Both solutions were proved to be superior to normal saline as a fluid therapy plan in most studies with much less ongoing hyperchloremic metabolic acidosis and inflammatory response. In this protocol, modified Del Nido formula will be involved using ringers' acetate instead of plasmalyte solutions and comparing the effects on myocardial protection versus HTK solutions **Detailed Description:** First, fulfilling all inclusion criteria and consent acceptance for study are to be confirmed. Preoperative evaluation is done for full laboratory investigations including CBC, coagulation, renal and liver functions, CRP and troponin, full clinical examination for chest and heart, coronary angiography, Echocardiography, carotid doppler and upper and lower venous and arterial doppler are to be done. All patients will be scheduled for on pump CABG surgery. Low dose of midazolam will be given before surgery. Intraoperative monitoring will involve invasive blood pressure, ECG, peripheral pulse oximetry, capnogram. After induction of anaesthesia and median sternotomy, patients will be randomly allocated into two groups: Group (D) will receive modified Del Nido cardioplegia (Ringer acetate 1000ml, mannitol 20% 17 ml, magnesium sulphate 10% 20ml, sodium bicarbonate 8.4% 16ml, potassium chloride 7.5% 13ml and lidocaine 2% 8 ml). Crystalloid to blood ratio will be 80% to 20% respectively. Dose will be 15 - 20 ml/kg in first dose then 8 - 10 ml/kg every 60 minutes. Group (C ) will receive HTK (Histidine, Tryptophan and Ketoglutarate solution) consisting of (1000ml distilled water, sodium 15mmol/L, potassium 9mmol/L, magnesium 4mmol/L, calcium 0.015 mmol/L, histidine 129mmol/L, tryptophan 2mmol/L, ketoglutarate 1mmol/L, mannitol 30mmol and pH 7.02 - 1.2). Dose will be 10 - 20 ml/kg and can be repeated once after 120 minutes. All patients will receive hypothermia 29 - 32 ℃ and cardioplegia will be injected between the aortic valve and aortic cross clamp in a pressure not less than 50 mmHg above systolic pressure. After removal of aortic cross clamping, the heart will be monitored for ventricular arrhythmias, early recovery, and postoperative 24 hours serum troponin and new changes in echocardiography. ### Conditions Module **Conditions:** - Cardiac Ischemia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 124 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** will receive HTK (Histidine, Tryptophan and Ketoglutarate solution) consisting of (1000ml distilled water, sodium 15mmol/L, potassium 9mmol/L, magnesium 4mmol/L, calcium 0.015 mmol/L, histidine 129mmol/L, tryptophan 2mmol/L, ketoglutarate 1mmol/L, mannitol 30mmol and pH 7.02 - 1.2). Dose will be 10 - 20 ml/kg and can be repeated once after 120 minutes. **Intervention Names:** - Biological: HTK **Label:** HTK custidiol **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** will receive modified Del Nido cardioplegia (Ringer acetate 1000ml, mannitol 20% 17 ml, magnesium sulphate 10% 20ml, sodium bicarbonate 8.4% 16ml, potassium chloride 7.5% 13ml and lidocaine 2% 8 ml). Crystalloid to blood ratio will be 80% to 20% respectively. Dose will be 15 - 20 ml/kg in first dose then 8 - 10 ml/kg every 60 minutes **Intervention Names:** - Biological: Ringer acetate based Del Nido cardioplegia **Label:** Del Nido **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Del Nido **Description:** All patients will receive hypothermia 29 - 32 ℃ and cardioplegia will be injected between the aortic valve and aortic cross clamp in a pressure not less than 50 mmHg above systolic pressure. After removal of aortic cross clamping, the heart will be monitored for ventricular arrhythmias, early recovery, and postoperative 24 hours serum troponin and new changes in echocardiography. **Name:** Ringer acetate based Del Nido cardioplegia **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - HTK custidiol **Description:** Giving HTK instead of Del Nido **Name:** HTK **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Sinus rhythm will be defined by the following criteria: Del Nido cardioplegia vs HTK. Regular rhythm at a rate of between 60 to 100bpm. - Presence of P waves that are followed by a QRS complex at a 1:1 rate. - A PR interval of between 120 and 200ms. **Measure:** Any arrhythmia other than sinus rhythm after cross-clamp removal and reperfusion **Time Frame:** after aortic declamping and reperfusion of the heart at the end of ischemia time during cardiopulmonary bypass #### Secondary Outcomes **Description:** serum level of troponin in microgram in deciliter **Measure:** postoperative serum troponin **Time Frame:** 24 hour postoperatively **Description:** for any new change from preoperative status **Measure:** postoperative echocardiography **Time Frame:** 24 hour postoperative ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. ≥ 18 years old 2. Any gender 3. Surgery demands cardiopulmonary bypass and cardioplegia. 4. CABG surgeries Exclusion Criteria: 1. \< 18 years old 2. Emergency surgeries 3. Off pump CABG surgeries 4. Taking cardioplegia other than Del Nido or HTK cardioplegia **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003327 - Term: Coronary Disease - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000001161 - Term: Arteriosclerosis - ID: D000001157 - Term: Arterial Occlusive Diseases - ID: D000014652 - Term: Vascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M6546 - Name: Coronary Artery Disease - Relevance: HIGH - As Found: Cardiac Ischemia - ID: M19506 - Name: Myocardial Ischemia - Relevance: HIGH - As Found: Cardiac Ischemia - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M6549 - Name: Coronary Disease - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M4469 - Name: Arteriosclerosis - Relevance: LOW - As Found: Unknown - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003324 - Term: Coronary Artery Disease - ID: D000017202 - Term: Myocardial Ischemia ### 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: AntiConv - Name: Anticonvulsants - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: NaAg - Name: Natriuretic Agents - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: BDCA - Name: Bone Density Conservation Agents - Abbrev: CaS - Name: Cardioplegic Solutions - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M11014 - Name: Lidocaine - Relevance: LOW - As Found: Unknown - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M11270 - Name: Magnesium Sulfate - Relevance: LOW - As Found: Unknown - ID: M5381 - Name: Calcium - Relevance: LOW - As Found: Unknown - ID: M11342 - Name: Mannitol - Relevance: LOW - As Found: Unknown - ID: M17115 - Name: Tryptophan - Relevance: LOW - As Found: Unknown - ID: M5398 - Name: Calcium, Dietary - Relevance: LOW - As Found: Unknown - ID: M5570 - Name: Cardioplegic Solutions - Relevance: LOW - As Found: Unknown - ID: M274130 - Name: Del Nido cardioplegia solution - Relevance: LOW - As Found: Unknown - ID: T21 - Name: Tryptophan - Relevance: LOW - As Found: Unknown - ID: T8 - Name: Histidine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414317 **Brief Title:** An Education and Navigation Support Tool to Improve Participation in Care Coordination Among Patients With Locally Advanced, Metastatic and Unresectable Bladder Cancer and Their Caregivers **Official Title:** A Comprehensive Education and Navigational Support Program for Advanced Bladder Cancer #### Organization Study ID Info **ID:** I-3368823 #### Organization **Class:** OTHER **Full Name:** Roswell Park Cancer Institute #### Secondary ID Infos **Domain:** CTRP (Clinical Trial Reporting Program) **ID:** NCI-2024-03446 **Type:** REGISTRY **Domain:** Roswell Park Cancer Institute **ID:** I-3368823 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2025-01-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-01-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-12 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Roswell Park Cancer Institute #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** This clinical trial evaluates the impact of an education and navigation support tool (ENST) on patient and caregiver participation in care coordination for bladder cancer that has spread to nearby tissue or lymph nodes (locally advanced), to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Patients with advanced bladder cancer tend to be older, have multiple medical conditions and often have poor access to health care. An ENST may be an effective method to improve participation in treatment decision-making and care planning among patients with locally advanced, metastatic and unresectable bladder cancer and their caregivers. **Detailed Description:** PRIMARY OBJECTIVES: I. To assess project readiness and barriers and requirements to assure success we will evaluate organizational readiness and implementation climate through stakeholder engagement. II. Development of an ENST to meet the needs of patients and caregivers, the delivery of which is deemed feasible based on such pre-implementation assessment. III. Implementation and delivery of the proposed ENST. IV. Facilitation of enhanced care coordination for patients with advanced bladder cancer who often have complex medical needs, using measures elaborated in the design and methods section. V. Determining the impact of such interventions, in a quantifiable manner, using validated instruments to assess perceptions of care coordination and self-efficacy, as well as monitoring concordance with guideline-recommended care by leveraging data from a network-wide decision support tool that captures systemic therapy selections. OUTLINE: Patients and caregivers receive access to the bladder cancer ENST and patients undergo psychological distress and nutrition screenings and may attend social work, psychology, and/or nutrition consultations as appropriate throughout the study. Patients, caregivers, and providers also attend virtual support group meetings periodically on study. ### Conditions Module **Conditions:** - Locally Advanced Bladder Carcinoma - Metastatic Bladder Carcinoma - Stage III Bladder Cancer AJCC v8 - Stage IV Bladder Cancer AJCC v8 - Unresectable Bladder Carcinoma ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 160 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients and caregivers receive access to the bladder cancer ENST and patients undergo psychological distress and nutrition screenings and may attend social work, psychology, and/or nutrition consultations as appropriate throughout the study. Patients, caregivers, and providers also attend virtual support group meetings periodically on study. **Intervention Names:** - Procedure: Assessment of Distress - Other: Consultation Visit - Other: Nutritional Assessment - Other: Questionnaire Administration - Other: Supportive Care **Label:** Supportive Care (ENST) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Supportive Care (ENST) **Description:** Undergo psychological distress screening **Name:** Assessment of Distress **Other Names:** - Assessment of Psychological Distress - Evaluation of Patient's Distress **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Supportive Care (ENST) **Description:** Attend consultations **Name:** Consultation Visit **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Supportive Care (ENST) **Description:** Undergo malnutrition screening **Name:** Nutritional Assessment **Other Names:** - Dietary Assessment - dietary counseling - nutritional counseling **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - Supportive Care (ENST) **Description:** Ancillary studies **Name:** Questionnaire Administration **Type:** OTHER #### Intervention 5 **Arm Group Labels:** - Supportive Care (ENST) **Description:** Receive access to bladder cancer ENST **Name:** Supportive Care **Other Names:** - Supportive Therapy - Symptom Management - Therapy, Supportive **Type:** OTHER #### Intervention 6 **Arm Group Labels:** - Supportive Care (ENST) **Description:** Attend virtual support group meetings **Name:** Supportive Care **Other Names:** - Supportive Therapy - Symptom Management - Therapy, Supportive **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** A 12 item instrument used to determine how well employees feel they can implement the change in process .. Each item includes a scale from 1 (Disagree ) to 5 (Agree) **Measure:** Organizational readiness for implementing change (ORIC) **Time Frame:** At baseline and at 6 months post-implementation **Description:** Guideline-concordant care at the institutional level will be calculated as the percentage of all systemic treatment decisions captured in the Clinical Oncology Pathway. **Measure:** Guideline-concordant care at the institutional level **Time Frame:** At baseline and at 6 months intervals for the study duration **Description:** Patient perception of care coordination will be measured using Care Coordination Instrument. **Measure:** Patient perception of care coordination **Time Frame:** At baseline and at 3 and 6 months post-implementation **Description:** Patient perception of self-efficacy will be measured using Generalized Self-Efficacy scale. A 10 item psychometric scale with 4 choice responses ranging from 1 (not at all true) to 4 (Exactly true). **Measure:** Patient perception of self-efficacy **Time Frame:** At baseline and at 3 and 6 months post-implementation **Description:** Caregiver perception of care coordination will be measured using Care Coordination Instrument for Caregivers. **Measure:** Caregiver perception of care coordination **Time Frame:** At baseline and at 3 and 6 months post-implementation ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * PATIENTS: Age ≥ 18 years * PATIENTS: Metastatic or locally advanced, unresectable bladder cancer * PATIENTS: Receiving or planning to receive systemic therapy for bladder cancer at Roswell Park Comprehensive Cancer Center (RPCCC) * PATIENTS: Subjects can be enrolled any time from initial diagnosis of advanced disease to within 8 weeks after initiation of first-line systemic therapy for advanced bladder cancer * PATIENTS: Able to speak, understand, read, and write English * CAREGIVERS: Age ≥ 18 years * CAREGIVERS: Only caregivers of enrolled patients will be included in the study * CAREGIVERS: Should be able to speak, understand, read, and write English * CAREGIVERS: Caregivers will be enrolled in the genitourinary (GU) clinic during the same time window as for patient enrollment (from initial visit to within 8 weeks of patients starting frontline therapy) Exclusion Criteria: * PATIENTS: Not receiving any form of systemic therapy for bladder cancer due to Eastern Cooperative Oncology Group (ECOG) performance status (PS) \> 3, co-morbidities, or inadequate organ function * PATIENTS: Predominantly small cell histology * PATIENTS: Adults with impaired decision-making capacity, assessed by the study team to be unable to participate in ENST-based education and surveys * PATIENTS: Pregnant women * CAREGIVERS: Cognitively impaired adults/adults with impaired decision-making capacity * CAREGIVERS: Individuals who are not yet adults (infants, children, teenagers) **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Buffalo **Contacts:** ***Contact 1:*** - **Email:** Dharmesh.Gopalakrishnan@RoswellPark.org - **Name:** Dharmesh Gopalakrishnan - **Phone:** 716-845-5967 - **Role:** CONTACT ***Contact 2:*** - **Name:** Dharmesh Gopalakrishnan - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Roswell Park Cancer Institute **State:** New York **Status:** RECRUITING **Zip:** 14263 #### Overall Officials **Official 1:** **Affiliation:** Roswell Park Cancer Institute **Name:** Dharmesh Gopalakrishnan **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000014571 - Term: Urologic Neoplasms - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000001745 - Term: Urinary Bladder Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M5030 - Name: Urinary Bladder Neoplasms - Relevance: HIGH - As Found: Bladder Cancer - 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: M17320 - Name: Urologic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M5026 - Name: Urinary Bladder Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000001749 - Term: Urinary Bladder Neoplasms ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414304 **Acronym:** BLOOMSI **Brief Title:** Dynamics of MSI and Genomic Profile of Colorectal Cancer In the Course of Immune Checkpoint Inhibitor Therapy **Official Title:** A Multi-center Observational Clinical Trial Evaluating the Dynamics of Microsatellite Instability and Genomic Profile of Colorectal Cancer in the Course of Treatment With Immune Checkpoint Inhibitors #### Organization Study ID Info **ID:** BLOOMSI #### Organization **Class:** INDUSTRY **Full Name:** OncoAtlas LLC #### Secondary ID Infos **Domain:** Russian Science Foundation **ID:** 22-75-10154 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2026-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Start Date **Date:** 2022-06-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** N.N. Blokhin National Medical Research Center of Oncology **Class:** UNKNOWN **Name:** Moscow MultidisciplinaryClinical Center Kommunarka #### Lead Sponsor **Class:** INDUSTRY **Name:** OncoAtlas LLC #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Colorectal cancer (CRC) is a leading cause of cancer-related mortality worldwide. Microsatellite instability or mismatch repair deficiency occurs in 20% of CRC, and is predominantly found in non-metastatic tumors. The success of the CheckMate 142 and KEYNOTE-177 clinical trials has shifted the treatment paradigm of the MSI/dMMR CRC, which has led to the adoption of immune checkpoint inhibitors (ICI) by international treatment standards. However, despite the encouraging effects of ICI, up to 30% of patients are resistant to treatment and exhibit rapid disease progression shortly after starting ICI. On the other hand, around 30% of patients treated with ICI demonstrate prolonged responses to the treatment with a duration of response of over 40 months. Furthermore, for \~10% of patients, treatment with ICI results in pseudo-progression - a phenomenon of a short-term increase followed by the decrease of the tumor volume. Currently, the mechanisms and biomarkers associated with the response or resistance to ICI in MSI-positive CRC are largely unknown. Select studies suggest that BRAF mutations (specifically, BRAF p.V600E) might negatively affect the patients' progression-free survival following ICI, however, these data are premature. The primary hypothesis is that the clonal heterogeneity and the evolution of MSI status of MSI-positive CRC will play a role in the development of ICI treatment resistance. The primary objective of the study is to investigate the dynamics of MSI status in serial liquid biopsy samples from patients with MSI-positive tumors receiving ICI. **Detailed Description:** This is a multicenter observational trial designed to evaluate the dynamics of microsatellite instability and the genomic profiles of CRC during immune checkpoint inhibitor treatment. Patients with MSI/dMMR-positive tumors who are candidates for the ICI treatment will be included in the study. MSI/dMMR positivity should be confirmed with polymerase chain reaction-based (PCR) assays, immunohistochemistry (IHC) or Next-generation sequencing (NGS). Treatment with any ICI will be allowed. Upon inclusion in the study, patients will be asked to provide the pre-treatment FFPE tumor and liquid biopsy (LB) samples along with LB samples on the 14th, 28th days of ICI, and at every control study. LB samples will be collected until treatment discontinuation. The pre-treatment FFPE samples will be tested with an alternative routine method (PCR and/or IHC, depending on what method was used for initial testing), as well as with the Solo Atlas Pro NGS panel covering common cancer-related genes and short tandem repeats for MSI detection. All LB samples will be tested with the Solo Atlas Pro NGS panel. Dynamics of MSI and genomic profiles will be correlated with the treatment outcomes. Disease response to study treatment will be evaluated by imaging methods. Response to treatment will be determined by RECIST v1.1. ### Conditions Module **Conditions:** - Colorectal Cancer - Colorectal Cancer Metastatic - MSI-H Colorectal Cancer - dMMR Colorectal Cancer - Cancer - Colon Adenocarcinoma **Keywords:** - MSI - dMMR - Microsatellite instability - Next-generation sequencing - Immunotherapy - Immune checkpoint inhibitors - Colorectal cancer ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 70 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Other Outcomes **Description:** Dynamics of biomarkers in serial liquid biopsy samples will be correlated with treatment outcomes. Response to treatment will be determined by RECIST v1.1. **Measure:** Correlation of biomarkers with the treatment outcomes **Time Frame:** Through study completion, an average of 3 years **Description:** Dynamics of ctDNA in serial liquid biopsy samples will be correlated with treatment outcomes. Response to treatment will be determined by RECIST v1.1. **Measure:** Evaluation of the ctDNA dynamics in the course of ICI in serial plasma samples **Time Frame:** Through study completion, an average of 3 years #### Primary Outcomes **Description:** Concordance will be calculated using Cohen's Kappa (κ) **Measure:** Concordance of NGS and routine methods (PCR, IHC) for MSI analysis **Time Frame:** Through study completion, an average of 3 years #### Secondary Outcomes **Description:** Concordance will be calculated using Cohen's Kappa (κ) **Measure:** Concordance of MSI in tumor tissue and liquid biopsy (ctDNA) **Time Frame:** Through study completion, an average of 3 years **Description:** Liquid biopsy samples will be collected prior to the start of ICI, on the 14th and 28th days of therapy and at every follow-up tumor scan **Measure:** Qualitative and quantitative status of MSI in serial liquid biopsy (ctDNA) samples **Time Frame:** Through study completion, an average of 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male/female participants must be at least 18 years of age on the day of signing informed consent and have a histologically confirmed diagnosis of colorectal cancer. * Verified MSI/dMMR positivity as measured by 5-loci PCR or 4-antibody IHC. * The patient is scheduled to start treatment with any of the immune checkpoint inhibitors 2-4 weeks after the inclusion in the study. * Have provided an archival tumor tissue sample obtained prior to the start of treatment with immune checkpoint inhibitor(s). Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. * Patient has to be able to provide serial blood samples during the course of treatment, as well as on every follow-up tumor scan. * The participant (or legally acceptable representative if applicable) provides written informed consent to participate in the trial. * Have measurable disease based on RECIST 1.1. * Have adequate organ function. Exclusion Criteria: * Prior treatment with immune checkpoint inhibitors. * For female participants: pregnancy or planned pregnancy. * The unavailability of the tumor or serial liquid biopsy samples. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with histologically confirmed colorectal cancer with microsatellite instability (MSI) or mismatch repair deficiency (dMMR) ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** maxim.ivanov@oncoatlas.ru **Name:** Maxim Ivanov, PhD **Phone:** +7 909 677-52-74 **Role:** CONTACT **Contact 2:** **Email:** lebedeva@oncoatlas.ru **Name:** Alexandra Lebedeva, MSc **Phone:** +7 915 417-36-77 **Role:** CONTACT #### Locations **Location 1:** **City:** Moscow **Contacts:** ***Contact 1:*** - **Name:** Olesya Kuznetsova, MD - **Role:** CONTACT **Country:** Russian Federation **Facility:** N.N.Blokhin National Medical Research Center of Oncology **Status:** RECRUITING **Zip:** 115478 **Location 2:** **City:** Moscow **Contacts:** ***Contact 1:*** - **Name:** Mikhail Fedyanin, MD, PhD - **Role:** CONTACT **Country:** Russian Federation **Facility:** State Budgetary Institution of Healthcare of the City of Moscow "Moscow Multidisciplinary Clinical Center "Kommunarka" of the Department of Health of the City of Moscow **Status:** RECRUITING **Zip:** 142770 #### Overall Officials **Official 1:** **Affiliation:** OncoAtlas LLC **Name:** Maxim Ivanov, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007414 - Term: Intestinal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000012002 - Term: Rectal Diseases - ID: D000042822 - Term: Genomic Instability - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M27510 - Name: Microsatellite Instability - Relevance: HIGH - As Found: Microsatellite Instability - ID: M17890 - Name: Colorectal Neoplasms - Relevance: HIGH - As Found: Colorectal Cancer - ID: M6338 - Name: Colonic Neoplasms - Relevance: HIGH - As Found: Colon Adenocarcinoma - ID: M10448 - Name: Intestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M14844 - Name: Rectal Diseases - Relevance: LOW - As Found: Unknown - ID: M25088 - Name: Genomic Instability - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015179 - Term: Colorectal Neoplasms - ID: D000003110 - Term: Colonic Neoplasms - ID: D000053842 - Term: Microsatellite Instability ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: LOW - As Found: Unknown - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414291 **Acronym:** LIV-D2O **Brief Title:** Rehydration Efficiency During Ad-libitum Fluid Intake **Official Title:** Rehydration Efficiency During Ad-libitum Fluid Intake #### Organization Study ID Info **ID:** FP00039672 #### Organization **Class:** OTHER **Full Name:** Arizona State University ### Status Module #### Completion Date **Date:** 2025-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-21 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Arizona State University #### Responsible Party **Investigator Affiliation:** Arizona State University **Investigator Full Name:** Stavros Kavouras **Investigator Title:** Professor & Assistant Dean **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** It is well established that rehydration with a carbohydrate-electrolyte solution is more effective in comparison to plain water. This is primarily based on the sodium-glucose co transporter, based on which the world health organization has based its oral rehydration solution recommendations. Also, rehydration with a solution that includes sodium and glucose plasma osmolality should not drop as much as it happens during rehydration with water. As a result, we should have higher fluid intake due to higher thirst perception and lower urinary output due to higher levels of vasopressin. The present study aims to examine the effectiveness of a electrolyte-glucose drink on rehydration following exercise-induced dehydration. ### Conditions Module **Conditions:** - Dehydration ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** SINGLE **Masking Description:** non labeled bottles **Who Masked:** - PARTICIPANT **Primary Purpose:** OTHER #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Rehydration with low mineral content bottle water **Intervention Names:** - Other: Plain Water **Label:** Water **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** Drink with 22 grams of carbohydrate, 1020 milligrams of sodium, and 760 milligrams of potassium per liter. Hydration multiplier liquid IV **Intervention Names:** - Other: Liquid IV Hydration Multiplier **Label:** Carbohydrate Electrolyte solution **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** 10 grams of carbohydrate, 1060 milligrams of sodium, and 760 milligrams of potassium per liter. Sugar free Liquid IV **Intervention Names:** - Other: Liquid IV Sugar Free **Label:** Low Sugar electrolyte solution **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Water **Description:** Plain water without calories, sweetener, or electolytes **Name:** Plain Water **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Carbohydrate Electrolyte solution **Description:** Drink with 22 grams of carbohydrate, 1020 milligrams of sodium, and 760 milligrams of potassium per liter. Hydration multiplier liquid IV **Name:** Liquid IV Hydration Multiplier **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Low Sugar electrolyte solution **Description:** 10 grams of carbohydrate, 1060 milligrams of sodium, and 760 milligrams of potassium per liter. Sugar free Liquid IV **Name:** Liquid IV Sugar Free **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Total amount of fluid ingested **Measure:** Total fluid intake **Time Frame:** 4 hours of rehydration **Description:** amount of water retained during the rehydration period **Measure:** Net fluid balance **Time Frame:** at 4 hours of the rehydration period **Description:** amount of water retained during the rehydration period **Measure:** Net fluid balance **Time Frame:** at 3 hours of the rehydration period **Description:** The rate of Deuterium appearance in the blood during 30 minutes of rehydration **Measure:** Rate of absorption **Time Frame:** during the first 30 minutes of rehydration **Description:** The rate of Deuterium appearance in the blood during 60 minutes of rehydration **Measure:** Rate of absorption **Time Frame:** during the first 60 minutes of rehydration **Description:** The rate of Deuterium appearance in the blood during 120 minutes of rehydration **Measure:** Rate of absorption **Time Frame:** during the first 120 minutes of rehydration **Description:** The rate of Deuterium appearance in the blood during 180 minutes of rehydration **Measure:** Rate of absorption **Time Frame:** during the first 180 minutes of rehydration **Description:** The rate of Deuterium appearance in the blood during 240 minutes of rehydration **Measure:** Rate of absorption **Time Frame:** during the first 240 minutes of rehydration **Description:** Total amount of urine output during rehydration **Measure:** Cumulative urine output **Time Frame:** during the first 3 hours of rehydration **Description:** Total amount of urine output during rehydration **Measure:** Cumulative urine output **Time Frame:** during the first 4 hours of rehydration #### Secondary Outcomes **Description:** Plasam Copeptin during rehydration **Measure:** Plasma copeptin **Time Frame:** at 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours of the rehydration period **Description:** percent of plasma volume recovery during the rehydration **Measure:** Plasma volume **Time Frame:** at 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours of the rehydration period **Description:** Free water clearance calculated based on plasma and urine osmolality **Measure:** Free water Clearance **Time Frame:** at 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours of the rehydration period **Description:** Free Osmotic clearance calculated based on plasma and urine osmolality **Measure:** Free Osmotic Clearance **Time Frame:** at 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours of the rehydration period **Description:** Thirst estimated with a visual analog scale from 0-125 millimeters with higher value indicating greater perception **Measure:** Thirst **Time Frame:** at 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours of the rehydration period **Description:** Stomach fullness estimated with a visual analog scale from 0-125 millimeters with higher value indicating greater perception **Measure:** Stomach fullness **Time Frame:** at 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours of the rehydration period **Description:** Taste Likeness estimated with a visual analog scale from 0-125 millimeters with higher value indicating greater perception **Measure:** Taste Likeness **Time Frame:** at 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours of the rehydration period ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 18-60 years * Training at least 2 times per week * stable weight for the last 2 months (fluctuation less than 5 pounds) Exclusion Criteria: * Night shifting work * Thyroid medication * Bariatric surgery * Cardiovascular disease * Renal disease * Hepatic disease * Participating in another study at the same time * Bodyweight over 110 pounds **Healthy Volunteers:** True **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** stavros.kavouras@asu.edu **Name:** Stavros Kavouras, PhD **Phone:** (602) 496-2547 **Role:** CONTACT #### Locations **Location 1:** **City:** Phoenix **Country:** United States **Facility:** Interdisciplinary Science and Technology Building 8 **State:** Arizona **Zip:** 85004 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014883 - Term: Water-Electrolyte Imbalance - ID: D000008659 - Term: Metabolic Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6883 - Name: Dehydration - Relevance: HIGH - As Found: Dehydration - ID: M17624 - Name: Water-Electrolyte Imbalance - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003681 - Term: Dehydration ### Intervention Browse Module - 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: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414278 **Brief Title:** Evaluation of Early Identification of Cognitive Side Effects of Immunotherapy **Official Title:** Early Identification of Cognitive Side-Effects of Immunotherapy #### Organization Study ID Info **ID:** 2022LS089 #### Organization **Class:** OTHER **Full Name:** Masonic Cancer Center, University of Minnesota #### Secondary ID Infos **Domain:** CTRP (Clinical Trial Reporting Program) **ID:** NCI-2023-09048 **Type:** REGISTRY **Domain:** University of Minnesota/Masonic Cancer Center **ID:** 2022LS089 **Type:** OTHER **ID:** P30CA077598 **Link:** https://reporter.nih.gov/quickSearch/P30CA077598 **Type:** NIH ### Status Module #### Completion Date **Date:** 2028-02-21 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-07-21 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-08 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Cancer Institute (NCI) #### Lead Sponsor **Class:** OTHER **Name:** Masonic Cancer Center, University of Minnesota #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This clinical trial evaluates the use of a tool kit, Stress, Affect, Language and Speech Analysis (SALSA), for early identification of cognitive side effects of immunotherapy compared to the standard of care assessment. **Detailed Description:** PRIMARY OBJECTIVES: I. To investigate the use of a toolkit for automated administration and scoring of cognitive tests (Stress, Language and Speech Analysis, or SALSA) in adult cancer patients who are treated with commercial chimeric antigen receptor T cell therapy (CAR-T) products at University of Minnesota and are at risk of developing immune effector cell-associated neurotoxicity syndrome (ICANS). OUTLINE: This is an observational study. Patients complete SALSA assessment and ICE assessments on study. Patients also have their medical records reviewed on study. ### Conditions Module **Conditions:** - Hematopoietic and Lymphatic System Neoplasm - Malignant Solid Neoplasm ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 38 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients complete SALSA assessment and ICE assessments on study. Patients also have their medical records reviewed on study. **Intervention Names:** - Other: Non-Interventional Study **Label:** Observational ### Interventions #### Intervention 1 **Arm Group Labels:** - Observational **Description:** Non-interventional study **Name:** Non-Interventional Study **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Descriptive statistics will be used to summarize the feasibility of SALSA in CAR-T patients. The overall completion rate of will be calculated for each patient, as well as the pattern of completions. **Measure:** Proportion of patients completing at least 80 percent of planned SALSA administrations during post CAR-T hospitalization **Time Frame:** 18 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * \* ≥ 18 years of age at initiation of therapy * Planning to undergo inpatient CAR-T therapy for primary malignancy * Fluent in English (written or spoken) Exclusion Criteria: * \* Subjects with speech or hearing impediment that would make them unable to be assessed with SALSA * Subjects with diagnosed cognitive impairment prior to CAR-T therapy * Unwilling or unable to sign voluntary written consent **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients planning to undergo CAR-T therapy for primary malignancy recruited through the University of Minnesota. ### Contacts Locations Module #### Locations **Location 1:** **City:** Minneapolis **Contacts:** ***Contact 1:*** - **Email:** bach0173@umn.edu - **Name:** Veronika Bachanova - **Phone:** 612-625-5469 - **Role:** CONTACT ***Contact 2:*** - **Name:** Veronika Bachanova - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of Minnesota/Masonic Cancer Center **State:** Minnesota **Status:** RECRUITING **Zip:** 55455 #### Overall Officials **Official 1:** **Affiliation:** University of Minnesota Masonic Cancer Center **Name:** Veronika Bachanova **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414265 **Acronym:** CASSINI-EU **Brief Title:** Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation **Official Title:** Reduction or Elimination of Mitral Regurgitation With the SATURN Trans-Septal TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - CASSINI-EU Trial #### Organization Study ID Info **ID:** TP-0181 #### Organization **Class:** INDUSTRY **Full Name:** InnovHeart ### Status Module #### Completion Date **Date:** 2030-02 **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:** 2025-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-04 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-04-29 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** MAXIS, LLC #### Lead Sponsor **Class:** INDUSTRY **Name:** InnovHeart #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this clinical trial is to evaluate feasibility, safety, and performance of the SATURN TS TMVR System for the treatment of moderate-to-severe or severe, symptomatic mitral regurgitation through a transcatheter approach. The main questions it aims to answer are: * is the use of the device feasible? * is it safe (defined as freedom from device-related major adverse events at 30 days)? * does it perform (defined as reduction of MR Grade to ≤ 1+ at 30 days)? Participants will need to do the following as part of the clinical trial: * complete 6-Minute Walking Test * complete Quality of Life Questionnaires * undergo blood evaluations * CT scan * 12 lead ECG * Transesophageal Echocardiography * Transthoracic Echocardiogram * the study procedure (valve implantation, right heart catheterization, left arterial pressure, fluoroscopy/ angiogram) **Detailed Description:** The SATURN Trans-Septal Transcatheter Mitral Valve Replacement System (SATURN TS System) is intended for use in adult patients suffering from heart failure symptoms (NYHA class II or greater) with moderate to severe or severe mitral regurgitation (MR ≥3+) who are deemed to be at high risk for open-heart mitral valve surgery by a multidisciplinary Heart Team including at least a cardiac surgeon and a cardiologist, experienced in the care of patients with mitral valve disease. CASSINI-EU is a single-arm, prospective, multicenter pilot trial. The purpose of the study is to evaluate feasibility, safety, and performance of the SATURN TS TMVR System for the treatment of moderate-to-severe or severe, symptomatic mitral regurgitation through a transcatheter approach. Primary objectives are to evaluate the feasibility, safety and performance of the SATURN TS TMVR System at 30 days. Secondary objectives and additional outcomes are long term safety and performance of the SATURN TS TMVR System. Up to 30 patients will be treated at up to 6 qualified investigational sites in Europe. ### Conditions Module **Conditions:** - Heart Failure ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_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:** SATURN Trans-septal Transcatheter mitral valve replacement (TMVR) System **Intervention Names:** - Device: Transcatheter mitral valve replacement **Label:** Treatment Arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment Arm **Description:** The SATURN TS TMVR System will be implanted through a transcatheter approach in patients with symptomatic mitral regurgitation. **Name:** Transcatheter mitral valve replacement **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Freedom from device-related major adverse events **Measure:** Safety Endpoint - Freedom from Device Related Major Adverse Events **Time Frame:** 30 days post-procedure **Description:** Technical success defined as alive patient at exit from procedure room with all the following: * Successful access, delivery of the SATURN TS Bioprosthesis, and retrieval of the TS Delivery Systems * Correct positioning of the first intended SATURN TS Bioprosthesis * Freedom from emergency surgery or mitral valve re-intervention related to the device or access procedure **Measure:** Technical Procedural Success Endpoint **Time Frame:** Procedure **Description:** Reduction of MR Grade to ≤ 1+ **Measure:** Efficacy Endpoint - Reduction of Mitral Regurgitation Grade to ≤ 1+ **Time Frame:** 30 days post-procedure ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age 65 years or older. 2. Symptomatic moderate to severe or severe functional mitral regurgitation (≥ Grade 3+). 3. NYHA functional Class ≥ II. If Class IV, patient must be ambulatory. 4. Ability to tolerate oral anticoagulation. 5. Ability to qualify for bailout surgery (which may include open heart surgery). 6. High risk for open-heart mitral valve surgery due to age, co-morbidities or frailty, as determined by the Heart Team. 7. Willing and able to complete study-related assessments and questionnaires. Exclusion Criteria: General Exclusion Criteria 1. Degenerative (i.e. intrinsic valve lesions) mitral regurgitation. 2. Excessive frailty or comorbid conditions that preclude the anticipated benefit of the mitral valve replacement. 3. Life expectancy \<1 year due to noncardiac conditions. 4. Endocarditis in the 3 months prior to procedure date. 5. Current admission with acute heart failure exacerbation. 6. Dependency on inotropic agents or mechanical circulatory support. 7. Untreated clinically significant CAD. 8. Active systemic infection. 9. Modified Rankin Scale ≥4 disability. 10. Chronic renal failure defined as eGFR \<30 mL/min/m2 or on renal replacement therapy. 11. Severe pulmonary arterial hypertension (PAH), defined as PASP \> 60mmHg. 12. Platelets \< 90,000. 13. COPD 2 on home oxygen therapy deemed too high risk for intubation. 14. Refuses blood transfusions. 15. Documented bleeding or coagulation disorders (hypo- or hyper-coagulable states). 16. Severe connective tissue disease under chronic immunosuppressive or cortisone therapy. 17. Participating in other investigational studies likely to confound the results or affect the study. 18. Unable or does not sign the study informed consent form. 19. Patients classified as "vulnerable patients" 3 . Cardiovascular Exclusion Criteria 20. Myocardial infarction during prior 30 days. 21. Stroke or TIA during prior 90 days. 22. Severe extracardiac arteriopathy (safety measure for extra-circulatory support if surgical conversion is needed). 23. Prior mitral valve treatment (e.g., valve repair or replacement, MitraClip, etc.), and/or anticipated mitral valve treatment prior to enrollment. 24. Prior surgical mechanical valve AVR. 25. Prior TAVI. 26. Need for any planned cardiovascular surgery or intervention (other than for MV disease) within 30 days post-index procedure. 27. CRT or ICD implanted in previous 30 days. 28. Cardiogenic shock, hemodynamic instability, Systolic Blood Pressure \<90mmHg, Inotropic dependent or requiring IABP/mechanical circulatory support. 29. CABG or PCI within previous 30 days. 30. Inadequately treated for cardiac condition per applicable standards, such as for coronary artery disease, left ventricular dysfunction, mitral regurgitation, or heart failure, as reviewed by the Patient Screening Committee. 31. Prior or planned heart transplantation (UNOS status 1). 32. Physical evidence of right-sided congestive heart failure: 1. Patients with ascites. 2. Patients with anasarca (generalized edema / hydropsy). 33. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or other structural heart disease causing heart failure with the exception of dilated ischemic or non-ischemic cardiomyopathy. Procedural Exclusion Criteria 34. Known hypersensitivity or contraindication to procedural or post-procedural medication (e.g., contrast solution, anticoagulation therapy). 35. Documented hypersensitivity to nickel or titanium. 36. Contraindications to TEE imaging Cardiac Imaging Exclusion Criteria 37. Left ventricular EF ≤ 30% by echocardiogram. 38. Severe mitral annular calcification, severe mitral stenosis, valvular vegetation or mass. 39. Extensive mitral flail leaflets 40. Evidence of new or untreated intracardiac thrombus, mass, or vegetation. 41. Severe right ventricular dysfunction. 42. Severe tricuspid regurgitation. 43. Hemodynamically significant inter-atrial shunt (ASD). 44. Severe aortic regurgitation or aortic stenosis. 45. Anatomic ineligibility for SATURN TS Bioprosthetic System or SATURN TS procedure as determined by the Screening Committee. **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** a.roach@innovheart.com **Name:** VP, Clinical Affairs InnovHeart **Phone:** +49 69 24003626 **Role:** CONTACT **Contact 2:** **Email:** maxisoperations@maxismedical.com **Name:** Maxis Operations **Role:** CONTACT #### Locations **Location 1:** **City:** Vilnius **Country:** Lithuania **Facility:** Vilnius University Hospital Santaros Klinikos **Status:** RECRUITING **Location 2:** **City:** Warsaw **Country:** Poland **Facility:** Warsaw Medical University **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** San Raffaele Hospital **Name:** Paolo Denti, 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 - ID: D000006349 - Term: Heart Valve Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M9421 - Name: Heart Failure - Relevance: LOW - As Found: Unknown - ID: M11910 - Name: Mitral Valve Insufficiency - Relevance: HIGH - As Found: Mitral Regurgitation - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M9437 - Name: Heart Valve Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008944 - Term: Mitral Valve Insufficiency ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414252 **Acronym:** FROSEN **Brief Title:** Social Evaluated Cold Pressor Test in Hereditary Angioedema Patients **Official Title:** Functional Physiological, Psychological and Biochemical Reactivity to Social Evaluated Cold Pressor Test in Hereditary Angioedema Patients #### Organization Study ID Info **ID:** 2774CE #### Organization **Class:** OTHER **Full Name:** Istituti Clinici Scientifici Maugeri SpA ### Status Module #### Completion Date **Date:** 2024-03-18 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-03-18 **Type:** ACTUAL #### Start Date **Date:** 2023-05-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Istituti Clinici Scientifici Maugeri SpA #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study aims to evaluate the differences in objective and subjective stress responses between patients with hereditary angioedema and healthy individuals to a stress-induced challenge like socially-evaluated cold pressure test. The study also investigates the role of psychological variables in influencing the stress response. **Detailed Description:** Stressful encounters, ranging from daily hassles to major life events, are ubiquitous in our everyday lives and are often responsible for significant changes in affective and cognitive processes. In various physical diseases, including hereditary angioedema (HAE) due to C1 inhibitor deficiency, stressful events are also frequently reported by patients to trigger acute attacks. These include physical stress (such as injury, pain, viral infections, medical and dental procedures, and surgery) and mental stress (including stress from life events and school or work, clinical depression, and anxiety), or stress originating from the disease itself, especially if the disease is characterized by an unpredictable nature like HEA that directly impacts patients' choices in everyday life. Available literature related to the link between HAE and stress is limited and mainly focused on the patients' narratives. Self-reported data suggested that the main HAE trigger seems to be stress, followed by physical trauma. These observations suggest analyzing the perceived psychological effects consequent to stress exposure together with biochemical and physiological responses. The effect of stress could be systematically examined in a laboratory environment using a standardized protocol that reliably induces stress and activates major stress responses in experimental contexts. A reliable test to induce stress in HAE patients combining these two aspects may be the Socially Evaluated Cold Pressor Test (SECPT). SECPT is an extension of the classical Cold Pressor Test, in which participants immerse one of their hands in ice water with socio-evaluative elements, and has been proven to be a highly efficient tool for experimental stress induction in humans. Adding social-evaluative elements to the original physical stress boosted the cortisol response, making the SECPT a well-established standard protocol in human stress research that may represent an efficient alternative to other established protocols, such as the Trier Social Stress Test, a 'gold standard' in the field. A recent review confirmed that exposure to the SECPT leads to changes in subjective feeling, and triggers a significant sharp increase in systolic and diastolic blood pressure. The present study aims to evaluate objective and subjective stress responses between HAE patients and healthy controls due to SECPT. Moreover, as secondary aims, the study wants to investigate if the presence of anxiety and depressive symptoms, as well as body appreciation, trust in the body, pain catastrophizing, pain interference, and pain intensity, affect or mediate stress response in patients and healthy subjects similarly or differently. ### Conditions Module **Conditions:** - Hereditary Angioedema **Keywords:** - Hereditary Angioedema - Autonomic nervous system - Cold pressor test - Stress - Body appreciation - Rare disease ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 40 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with documented diagnosis of hereditary angioedema due to C1 inhibitor deficiency and aged between 18 and 65 years. **Label:** Patients with hereditary angioedema #### Arm Group 2 **Description:** Healthy individuals with an age between 18 and 65 and matched with patients with hereditary angioedema by age and gender. **Label:** Healthy individuals ### Outcomes Module #### Primary Outcomes **Description:** Changes in the heart rate (beats per minute) from resting to SECPT condition **Measure:** Heart rate **Time Frame:** Baseline **Description:** Changes in the systolic blood pressure (mmHg) from resting to SECPT condition **Measure:** Systolic arterial pressure **Time Frame:** Baseline **Description:** Changes in the systolic blood pressure (mmHg) from resting to SECPT condition **Measure:** Diastolic arterial pressure **Time Frame:** Baseline **Description:** Changes in the perceived stress due to SECP. Scores ranges from 0 (no stress) to 100 (worst stress possible) **Measure:** Visual Analogue Scale of perceived stress **Time Frame:** Baseline **Description:** Changes in the concentration of inflammatory cytokines (pg/ml) due to SECPT **Measure:** Concentration of inflammatory cytokines **Time Frame:** Baseline **Description:** Changes in the concentration of plasma cathecolamines (pg/ml) due to SECPT **Measure:** Concentration of plasma cathecolamines **Time Frame:** Baseline #### Secondary Outcomes **Description:** A 14-item questionnaire subdivided in two subscales to measure anxiety and depression. Scores for each subscale ranges from 0 (absence of symptoms) to 21 (significant symptoms) **Measure:** Hospital Anxiety and Depression Scale **Time Frame:** Baseline **Description:** A 10-item questionnaire to measure stress levels related to the perception of unpredicable, uncontrollable, and overloading nature of life. Scores ranges from 0 (low levels) to 40 (high levels). **Measure:** Perceived Stress Scale (PSS-10) **Time Frame:** Baseline **Description:** A 32-item questionnaire to measure Interoceptive Awareness. Scores ranges from 0 (low interoceptive awareness) to 160 (high interoceptive awareness). **Measure:** Multidimensional Assessment of Interoceptive Awareness Version 1 **Time Frame:** Baseline **Description:** A 10-item questionnaire to measure appreciation. Scores ranges from 10 (low body appreciation) to 50 (high body appreciation). **Measure:** Body Appreciation Scale-2 (BAS-2) **Time Frame:** Baseline **Description:** A 7-item questionnaire to measure body appreciation. Scores ranges from 0 (low functionality appreciation) to 35 (high functionality appreciation) **Measure:** Functionality Appreciation Scale (FAS) **Time Frame:** Baseline **Description:** A 13-item questionnaire to measure pain-related catastrophizing. Scores ranges from 0 (low catastrophizing ) to 52 (high catastrophizing). **Measure:** Pain Catastrophizing Scale (PCS) **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Documented diagnosis of hereditary angioedema due to C1 inhibitor deficiency aged between 18 and 65 years (for the group of patients) Exclusion Criteria: * Any type of chronic disease requiring chronic treatment (i.e. hypertension, previous myocardial infarction, diabetes, chronic heart failure, autoimmune disease, neurodegenerative disease) * Active acute disease; * Sars-Cov2 infection in the previous 3 months. * An acute attack experienced within the previous week and within 72 hours after the registration (a posteriori exclusion). **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The group of patients with hereditary angioedema were recruited during an out-patient visit in a tertiary care center. The group of healthy individuals were volunteers recruited from community. ### Contacts Locations Module #### Locations **Location 1:** **City:** Milan **Country:** Italy **Facility:** Istituti Clinici Scientifici Maugeri **Zip:** 20138 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000014581 - Term: Urticaria - ID: D000017445 - Term: Skin Diseases, Vascular - ID: D000012871 - Term: Skin Diseases - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases - ID: D000081208 - Term: Hereditary Complement Deficiency Diseases - ID: D000081207 - Term: Primary Immunodeficiency Diseases - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000007153 - Term: Immunologic Deficiency Syndromes ### 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: BC14 - Name: Heart and Blood Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M24518 - Name: Rare Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M4127 - Name: Angioedema - Relevance: HIGH - As Found: Angioedema - ID: M27584 - Name: Angioedemas, Hereditary - Relevance: HIGH - As Found: Hereditary Angioedema - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M17330 - Name: Urticaria - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M19714 - Name: Skin Diseases, Vascular - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M6879 - Name: Deficiency Diseases - Relevance: LOW - As Found: Unknown - ID: M2286 - Name: Hereditary Complement Deficiency Diseases - Relevance: LOW - As Found: Unknown - ID: M10199 - Name: Immunologic Deficiency Syndromes - Relevance: LOW - As Found: Unknown - ID: M2285 - Name: Primary Immunodeficiency Diseases - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: T2734 - Name: Hereditary Angioedema - Relevance: HIGH - As Found: Hereditary Angioedema ### Condition Browse Module - Meshes - ID: D000000799 - Term: Angioedema - ID: D000054179 - Term: Angioedemas, Hereditary ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M26365 - Name: Complement C1 Inhibitor Protein - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414239 **Acronym:** REVENDO **Brief Title:** Improvement of Lower Digestive Endoscopy Without Anesthesia : Evaluation of the Virtual Reality Mask **Official Title:** Amélioration du Taux de succès de la Coloscopie Totale Lors Des Endoscopies Digestives Sans anesthésie : évaluation du Masque de réalité Virtuelle #### Organization Study ID Info **ID:** APHP220675 #### Organization **Class:** OTHER **Full Name:** Assistance Publique - Hôpitaux de Paris ### Status Module #### Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-04-29 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assistance Publique - Hôpitaux de Paris #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** 90% of colonoscopies are performed with general anesthesia (GA). GA carries risks and requires a prior anesthesia consultation, a dedicated team and technical platform on the day of the examination. These constraints increase the time it takes to organize examinations. This was particularly highlighted during the recent health crisis. The success of colonoscopy without GA varies depending on the patient's experience of the examination. Any measure allowing better tolerance of the exam is therefore likely to increase its success rate and avoid rescheduling the exam under GA. A 2017 meta-analysis showed that the use of virtual reality (VR) reduced pain and anxiety during care for burn victims, in trauma and oncology. In upper digestive endoscopy, retrospective studies have shown good tolerability of the examinations and a reduction in pain compared to patients with only local anesthesia. Thus, if the VR mask improves the success rate of total colonoscopy by improving tolerance and acceptability, more examinations without GA could be considered. It could also have an economic impact. ### Conditions Module **Conditions:** - Digestive System Disease **Keywords:** - Lower digestive endoscopy whatever the indication - Digestive endoscopy - Colonoscopy - Virtual reality ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized 1:1 ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 240 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Coloscopy with a virtual reality mask **Intervention Names:** - Device: Use of a VR mask **Label:** Interventional group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Coloscopy without any premedication or anesthesia **Intervention Names:** - Other: Standard of care **Label:** Control group **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Interventional group **Description:** Virtual reality mask **Name:** Use of a VR mask **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Control group **Description:** Without any premedication or anesthesia **Name:** Standard of care **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Success of a total colonoscopy defined by the rate of cecal intubation (visualization of the ileocecal valve and the appendicular orifice with the endoscope located near the appendicular orifice) or visualization of the ileocecal anastomosis in case of history of surgery removing the ileocaecal valve **Measure:** Rate of cecal intubation **Time Frame:** At day 0 #### Secondary Outcomes **Description:** The scale varies from 0 to 10. 0 is no pain, 10 is the worst possible pain **Measure:** Maximum pain assessed by the patient by numerical scale **Time Frame:** At day 0 **Description:** The scale varies from 0 to 10. 0 is no pain, 10 is the worst possible pain **Measure:** Maximum pain assessed by the patient by numerical scale **Time Frame:** At 1 month **Description:** The scale varies from 0 to 10. 0 is no anxiety, 10 is the worst possible anxiety **Measure:** Maximum anxiety assessed by the patient by numerical scale **Time Frame:** At day 0 **Description:** The scale varies from 0 to 10. 0 is no anxiety, 10 is the worst possible anxiety **Measure:** Maximum anxiety assessed by the patient by numerical scale **Time Frame:** At 1 month **Description:** It will be assesses by the Likert scale **Measure:** Patient's opinion to repeat the examination under the same conditions **Time Frame:** At day 0 **Description:** It will be assesses by the Likert scale **Measure:** Patient's opinion to repeat the examination under the same conditions **Time Frame:** At 1 month **Description:** Time between introduction and removal of the colonoscope **Measure:** Duration of the examination **Time Frame:** At day 0 **Description:** time between entering and leaving the room **Measure:** Total duration of the procedure **Time Frame:** At day 0 **Description:** Between the introduction of the colonoscope and 30 minutes maximum. It can be the ileum in the event of a history of surgery removing the valve. **Measure:** Number of minutes from visualization of the valve between the introduction of the colonoscope and 30 minutes maximum **Time Frame:** At day 0 **Measure:** Proportion of procedures where the VR mask is removed at the patient's request **Time Frame:** Up to 30 months **Measure:** Proportion of colonoscopies with detection of at least one adenoma **Time Frame:** Up to 30 months **Measure:** Proportion of VR device malfunctions (≥ 1) during the procedure in the intervention group **Time Frame:** Up to 30 months **Description:** Assessed by the Analogue Visual Scale examination **Measure:** Operator satisfaction **Time Frame:** Up to 30 months **Measure:** Incremental cost effectiveness ratio or incremental cost-result ratio in the form of cost per additional colonoscopic success **Time Frame:** Up to 30 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Patient over 18 years old with an indication for total colonoscopy and accepting without General Anesthesia Exclusion Criteria: * Hearing problems or low vision * Psychiatric or cognitive disorders hindering communication * History of epilepsy * Claustrophobia which can lead to a rejection of the virtual reality mask * History of cybercynetosis during previous use of VR * Chronic abdominal pain with baseline Visual analogue scale (VAS) \> 5 * Emergency examination * Patient participating in another interventional research on digestive endoscopy * Patient not speaking French * Patient under guardianship **Maximum Age:** 100 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** mylinh.tranminh@aphp.fr **Name:** My-Linh TRAN-MINH, Dr **Phone:** +33142499597 **Role:** CONTACT **Contact 2:** **Email:** jerome.lambert@u-paris.fr **Name:** Jérôme Lambert, Pr **Phone:** +33142499742 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: HIGH - As Found: Digestive System Diseases - ID: M7255 - Name: Digestive System Diseases - Relevance: HIGH - As Found: Digestive System Diseases ### Condition Browse Module - Meshes - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414226 **Brief Title:** Comparison of Krill and Fish Oil on Clinical and Biochemical Outcomes in Depression **Official Title:** Investigation of the Effect of Krill and Fish Oil Intake on Clinical and Biochemical Findings and Eating Behavior in Adult Individuals With Major Depression Disorders #### Organization Study ID Info **ID:** 2021/05-35 #### Organization **Class:** OTHER **Full Name:** Firat University ### Status Module #### Completion Date **Date:** 2022-10-24 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-07-04 **Type:** ACTUAL #### Start Date **Date:** 2022-03-21 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-04-17 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Adiyaman University Research Hospital #### Lead Sponsor **Class:** OTHER **Name:** Firat University #### Responsible Party **Investigator Affiliation:** Firat University **Investigator Full Name:** Murat Açık **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:** The Omega-3 polyunsaturated fatty acids (n-3 PUFA), associated with fish oil, has been one of the most studied non-pharmacological subjects for its effect on Major Depression Disorder (MDD). However, studies comparing the effect of krill oil, on depression are limited, that has similar content and different structural forms with fish oil. This study was conducted to evaluate the effectiveness of the use of krill and fish oil on clinical effects, biochemical outcomes and eating behavior in individuals diagnosed with MDD. It was included 57 adult individuals diagnosed with MDD in the psychiatry clinic in this study. Randomization was performed after inclusion and exclusion criteria were applied in the study, and participants were included in one of three groups. These groups are; 1) krill oil ((n=17), (Eicosapentaenoic acid (EPA)=340 mg, Docosahexaenoic acid (DHA)=180 mg)), 2) fish oil ((n=17)), (EPA=360 mg, DHA=240 mg), 3) placebo ( (n=16), (EPA=0 mg, DHA=0 mg)). The duration of the intervention was 8 weeks. Anthropometric measurements, biochemical outcomes and food consumption records of the participants were taken at the beginning and end of the intervention, and Hamilton depression rating scale (HDRS), depression anxiety stress-21 (DASS-21) and food craving questionnaire (FCQ) was applied to the participants. Statistical Package for Social Sciences (SPSS) and R studio software were used for statistical analysis of the data. **Detailed Description:** Introduction Major Depressive Disorder (MDD) affects approximately 6% of the adult population worldwide each year and is the second greatest contributor to the burden of chronic disease. In the treatment of MDD, both psychotherapy and psychopharmacology are effective. However, approximately 30% of patients do not achieve definitive recovery even after several treatment attempts. Major depressive disorder can affect an individual's life as a whole and is difficult to treat due to its high rate of relapse, and it is often associated with anxiety and cardiovascular diseases (CVD), which can threaten an individual's life. It is estimated that major depression is responsible for 3% of the global burden of disease according to the World Health Organization (WHO) report and that this rate may increase to 7% by 2030. Therefore, alternatives to effective treatments and prevention strategies are urgently needed due to this increasing trend. Omega-3 polyunsaturated fatty acids (n-3 PUFAs), identified with fish oil, became one of the most researched nutritional topics on the effects of major depressive disorder. Omega-3 polyunsaturated fatty acids are shown to be effective in cardiovascular disease (CVD) prevention due to their anti-inflammatory and cardio-protective effects. It can potentially share common mechanisms with CVD, considering factors such as increased production of pro-inflammatory cytokines, endothelial dysfunction and increases in plasma homocysteine levels, which play a role in the pathophysiology of some psychiatric disorders such as depression. It is possible that omega-3 has multiple positive effects on depression through its neurogenesis and neuroplasticity abilities, as well as having a positive effect on pathophysiological mechanisms. Appleton et al. conducted a Cochrane review to investigate the effect of n-3 PUFA supplements on depression in adults. This review included 25 studies (total 1438 participants) investigating the effect of n-3 PUFA supplements versus placebo and 1 study (40 participants) comparing n-3 PUFA supplements with antidepressant treatment. As a result, it was reported that n-3 PUFA supplements had a modestly positive effect on depression compared to placebo. However, it was emphasized in this report that the majority of the studies (22 studies) had a low level of evidence. This was attributed to factors such as high levels of bias, duration of follow-up, methodological errors and deficiencies due to blinded designs. The general conclusion of the authors was that there was a need for high quality intervention studies in this field. Although there are a large number of studies focusing on the use of fish oil in depression, research using krill oil, another source rich in n-3 PUFAs, is very limited. Krill oil is an important shellfish that lives in the oceans around the Antarctic continent and attracts attention in research due to its rich omega-3 fatty acid content. As krill is a species living in cold regions, they are rich in EPA and DHA content, along with PUFAs in the form of phospholipids and especially phosphatidylcholine in cell membrane structures. The form containing and binding Docosahexaenoic acid (DHA) and Eicosapentaenoic acid (EPA) in krill oil is phospholipids, contrary to triglyceride in fish oil. Therefore, the absorption and bioavailability activities are different because of the difference in the forms in fish and krill oil. Although there are studies on the effects of krill oil on the nervous system on the human research, there is limited research on the effectiveness of krill oil on depression. To our knowledge, there was only one pilot study on rats comparing the treatment efficacy of fish and krill oil on depression. This study compared the antidepressant effects of krill (EPA: 60 mg/500 mg, DHA: 35 mg/500 mg) and fish oil (EPA: 90 mg/500 mg, DHA: 60 mg/500 mg), vitamin B12 and imipramine. As a result, krill oil showed favorable results on a number of variables compared to fish oil, but similar results were found in both groups. It is important to compare the efficacy of krill and fish oil with similar EPA and DHA content on depression to clarify the question of which of these oils in different forms may be more effective on the disease. Major depressive disorders affect many mechanisms such as food intake, taste perception and food selection. When clinical pictures related to the nutritional status of depressed individuals are examined; changes in appetite, increased consumption of certain food groups and related changes in body weight are frequently observed. In addition, antidepressant drugs used may also affect food intake and weight control. Eating behavior is under the control of complex neural mechanisms, especially serotonin. At the same time, food intake is also effective in the control of serotonin release in serotonergic neurons. Serotonin, which has a bidirectional relationship with eating behavior, is a neurotransmitter involved in the physiopathology of many psychiatric disorders. The presence of a disorder in the serotonin pathway may explain the development of both psychiatric disorders and obesity in the patient. As a result, it was reported that eating behavior disorders, interest in unhealthy food consumption and increased appetite in major depressives, as in some psychiatric disorders, may lead to an increase in body weight in individuals during the illness or in progressive processes. There are several studies examining the relationship between depression and obesity. However, clinical studies to determine the factors leading to this condition are limited. In addition, data collection on eating behavior, appetite and weight status is neglected in most clinical interventions in patients with depression. Therefore, it is important to investigate the efficacy of n-3 fatty acids on appetite and body composition as well as eating behaviors that examine food cravings in depressed individuals. Considering all of these opinions, this study aimed to determine the effectiveness of krill and fish oil on clinical effects, biochemical findings and eating behavior in individuals diagnosed with MDD and to compare the results with the control group. METHODS This study was designed with a randomized double-blind placebo-controlled. The study was conducted in the Psychiatry Clinic of Adıyaman University Training and Research Hospital with 50 patients over the age of 18 diagnosed with MDD. The duration of the intervention for each participant was 8 weeks. The included patients received fish oil or krill oil or placebo. The study was conducted in accordance with good clinical guidelines and in accordance with the Declaration of Helsinki. Ethical approval was also obtained from the Ethics Committee of Fırat University. Participants The study was enrolled with 66 patients with MDD who were over 18 years of age and fulfilled the inclusion criteria. Inclusion criteria were; 1) being diagnosed with major depression by a psychiatrist in accordance with DSM V diagnostic criteria 2) not taking antidepressant medication or being on antidepressant medication for the last 1 month without medication change 3) signing the informed consent form. The exclusion criteria were as follows; 1) those who used more than two antidepressants 2) substance users in the last 6 months 3) alcohol dependence 4) suicidal ideation and suicidal tendencies (followed up by clinicians) 5) presence of other psychiatric disorders such as comorbid psychosis, schizophrenia and bipolar (excluding dysthymia and anxiety) 6) Presence of serious chronic diseases 7) pregnant or lactating women 8) Medication users that may cause emotional symptoms (Escitoloprom/Lexopro etc.) 9) food allergies 10) individuals at high risk of bleeding or those taking anti-coagulant drugs such as warfarin 11) Consumers of 3 or more servings of fish per week 12) Using any nutritional supplement 13) Hypercholesterolemia or taking medication for hypercholesterolemia 14) those who did not sign the informed consent form. Sample Size and Randomization and Blinded The sample size was determined based on the findings of a similar study, using the G\* power 3.1.9.7 software program with an effect size of 0.224, 95% confidence interval, and a margin of error of 0.05. This study was a randomized controlled double-blind study design. The assignment of patients to groups (randomization) was performed by a statistician who was not involved in the research and was concealed from the patients. At the first stage, stratified randomization was performed to ensure homogeneous distribution of patients according to age and gender, and then simple randomization was performed from each layer to ensure equal assignment to all groups. Each patient was assigned a number between 1-60 and then stratified according to gender (male and female) and age group (18-34 and 35-64 years). In the last stage, numbers were generated with the R studio statistical program to assign an equal number of patients to each group. The statistician randomly assigned the color codes on the capsule bottles to each group and each group received the test products from the researcher in a closed package according to the color codes. These color codes were not known by the researchers and patients until the endpoint of the study. In addition, the researcher, clinician, and participant were blinded until the study was reported. Intervention The researcher conducted three 45-minute interviews with the participants for 8 weeks at the beginning, mid and end of the study. In the first interview, patients were given the product they should receive for 8 weeks in closed boxes. Hamilton Depression Rating Scale in the questionnaire form was completed by the clinician to assess the degree of depression and clinical status of the participants. Then, the remaining parts of the questionnaire were directed to the patients. Anthropometric measurements were performed after completion of the questionnaire. Blood samples were collected from participants at the beginning and end of the study to analyze biochemical outcomes. The second interview was conducted at mid-study at the end of week 4 and the final interview was conducted at the end of week 8. In the second interview with the patients, the same procedures were performed except for the collection of blood samples and the food craving scale. In the last interview, the protocols were the same except for product administration. Participants were prescribed a daily dose of 4 capsules (4×500 mg= 2 g/day) stored at the appropriate temperature during the 8-week treatment period. Patients were informed to take 2 of the capsules in the daily oral bottle in the morning before breakfast and the other 2 capsules before dinner. The capsule bottles contained 500 mg concentrated krill oil, fish oil or placebo capsules. The daily intake of EPA+DHA from krill and fish oil was determined as 520 mg and 600 mg, respectively. Data Collection Data of the participants were collected at the beginning, middle and end of the study, three times in total, by face-to-face interview with a questionnaire form. The questionnaire included sociodemographic characteristics, health information, lifestyle, Hamilton Depression Rating Scale, Depression-Anxiety-Stress Scale, Food Cravings Scale, anthropometric measurements and one-day food consumption record. Statistical Analysis Statistical Package for Social Sciences (SPSS) and R studio software program were used for statistical analysis of the data. The mean and standard deviation values were given for continuous data that met the normal distribution condition, otherwise the median and quartiles (25th and 75th quartile values) were given. Categorical data were presented as frequency and percentage. One-way ANOVA test was used to compare continuous variables that met the normal distribution condition between the groups, and Kruskal-Wallis H test was used for those that did not meet the normal distribution condition. Pearson chi-square test was used to compare categorical data. Repeated measures ANOVA (General linear model) test was used in the comparison of more than two dependent variables if they met the normal distribution condition. To evaluate the differences between groups, p time, p group and p group×time interaction effect were shown. The p time value expresses the comparison of any numerical variable in the group between times. The p time×groups value expresses the comparison of the numerical variable between the groups depending on time. In other words, it gives information about whether the study groups have superiority over each other during the intervention period on any variable. In addition, partial eta square values are presented for the effect size of the interaction effect of group and time. A partial eta squared value of \<0.06 indicates a "small" effect size, a value between 0.06-0.14 indicates a "medium" effect size and a value \>0.14 indicates a "large" effect size. In addition, the standardized mean differences, standard error, 95% confidence interval and p-values of the participants' depression, anxiety and stress scores within each group were presented. Bonferroni correction was used to calculate the p-value. If the normal distribution condition was not met, Friedman test was used and if p\<0.05, Wilcoxon test was performed in paired groups and Bonferroni correction was used to calculate the p value. In addition, after the classification of depression, anxiety and stress within the groups, the Stuart-Maxwell test (R studio) was used to test the statistical significance of the changes in the severity of the disease before and after the intervention. The results were evaluated at 95% confidence intervals and a pairwise p\<0.05 was considered statistically significant. References 1. Bromet, E., et al., Cross-national epidemiology of DSM-IV major depressive episode. BMC medicine, 2011. 9: p. 1-16. 2. Rush, A.J., et al., Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR\* D report. Focus, 2008. 6(1): p. 128-142. 3. Thase, M.E., et al., Cognitive Therapy Versus Medication in Augmentation and Switch Strategies as Second-Step Treatments: A STAR\* D Report. Focus, 2008. 6(1): p. 104-119. 4. Organization, W.H., Depression. Fact sheet No. 369/October 2012. 2015. 5. Rangel-Huerta, O.D. and A. Gil, Omega 3 fatty acids in cardiovascular disease risk factors: An updated systematic review of randomised clinical trials. Clinical nutrition, 2018. 37(1): p. 72-77. 6. Buoite Stella, A., et al., Update on the impact of omega 3 fatty acids on inflammation, insulin resistance and sarcopenia: a review. International journal of molecular sciences, 2018. 19(1): p. 218. 7. Crupi, R., A. Marino, and S. Cuzzocrea, n-3 fatty acids: role in neurogenesis and neuroplasticity. Current medicinal chemistry, 2013. 20(24): p. 2953-2963. 8. Appleton, K.M., et al., Omega-3 fatty acids for depression in adults. Cochrane Database of Systematic Reviews, 2021(11). 9. Burri, L., Krill oil supplementation and cognitive function, in Diet and Nutrition in Dementia and Cognitive Decline. 2015, Elsevier. p. 1031-1038. 10. Colletti, A., et al., Advances in technologies for highly active omega-3 fatty acids from krill oil: Clinical applications. Marine Drugs, 2021. 19(6): p. 306. 11. Adıgüzel, K.T., K. Işgın, and G. Pekcan, Krill yağı desteği ve yeni bilimsel kanıtlar. Beslenme ve Diyet Dergisi, 2015. 43(3): p. 258-263. 12. Di Marzo, V., et al., Dietary krill oil increases docosahexaenoic acid and reduces 2-arachidonoylglycerol but not N-acylethanolamine levels in the brain of obese Zucker rats. International dairy journal, 2010. 20(4): p. 231-235. 13. Konagai, C., et al., Effects of krill oil containing n-3 polyunsaturated fatty acids in phospholipid form on human brain function: a randomized controlled trial in healthy elderly volunteers. Clinical interventions in aging, 2013: p. 1247-1257. 14. Zadeh-Ardabili, P.M., et al., Antidepressant-like effects of fish, krill oils and Vit B12 against exposure to stress environment in mice models: current status and pilot study. Scientific reports, 2019. 9(1): p. 19953. 15. Wurtman, R.J. and J.J. Wurtman, Brain serotonin, carbohydrate-craving, obesity and depression. Obesity research, 1995. 3(S4): p. 477S-480S. 16. Paans, N.P., et al., Depression and eating styles are independently associated with dietary intake. Appetite, 2019. 134: p. 103-110. 17. Lopresti, A.L., S.D. Hood, and P.D. Drummond, A review of lifestyle factors that contribute to important pathways associated with major depression: diet, sleep and exercise. Journal of affective disorders, 2013. 148(1): p. 12-27. 18. SM, S., Stahl'ın temel psikofarmakolojisi: nörobilimsel ve pratik uygulamalar. Cambridge University Press. T Uzbay (çev. ed.), 2012. 3: p. 535-6. 19. Blaine, B., Does depression cause obesity? A meta-analysis of longitudinal studies of depression and weight control. Journal of health psychology, 2008. 13(8): p. 1190-1197. 20. Luppino, F.S., et al., Overweight, obesity, and depression: a systematic review and meta-analysis of longitudinal studies. Archives of general psychiatry, 2010. 67(3): p. 220-229. 21. Lespérance, F., et al., The efficacy of omega-3 supplementation for major depression: a randomized controlled trial. Journal of Clinical Psychiatry, 2011. 72(8): p. 1054. ### Conditions Module **Conditions:** - Depression **Keywords:** - depression - anxiety - fish oil - krill oil - eating behavior ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomised Controlled Double-Blinded ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 57 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Krill oil ((n=17), (EPA=340 mg, DHA=180 mg)), The duration of the intervention was 8 weeks. **Intervention Names:** - Dietary Supplement: Krill and Fish Oil vs. Placebo **Label:** Krill group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 2) fish oil ((n=17)), (EPA=360 mg, DHA=240 mg), The duration of the intervention was 8 weeks. **Intervention Names:** - Dietary Supplement: Krill and Fish Oil vs. Placebo **Label:** Fish group **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Placebo capsule ( (n=16), (EPA=0 mg, DHA=0 mg)). The duration of the intervention was 8 weeks. **Intervention Names:** - Dietary Supplement: Krill and Fish Oil vs. Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Fish group - Krill group - Placebo **Description:** Participants were prescribed to take a daily dose of 4 capsules (4×500 mg= 2 g/day) stored at an appropriate temperature during the 8-week treatment period. The patients were informed to take 2 of the capsules in the bottle to be taken orally daily in the morning before breakfast and the other 2 capsules before dinner. The capsule bottles contained 500 mg concentrated krill oil, fish oil or placebo (empty capsule) capsules. The daily intake of EPA+DHA from krill and fish oil was determined as 520 mg and 600 mg, respectively. Krill and fish oil were obtained from Aniqnaturals Superba and Orzax Ocean company, respectively. **Name:** Krill and Fish Oil vs. Placebo **Other Names:** - Aniqnaturals Superba Krill Oil - Ocean Fish Oil **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Other Outcomes **Description:** Food Cravings Questionnaire Scale: The FCQ scale consists of 39 items and 9 factors.Sub-dimensions of the scale; intention and planning to consume food (3 items), expectation of positive reinforcement that may arise from eating, expectation of relief from negative situations and emotions arising from eating, the possibility of lack of eating control if food is eaten, preoccupation with food and thoughts, craving as a physiological domain, feelings that may be experienced before or during the desire to eat or eating, cues that may trigger the desire to eat, guilt that may be experienced as a result of giving in to desire and/or craving. All of the items in the scale are 6-point Likert type. The score of the scale is obtained by dividing the total item scores by the number of items. The scores obtained in this way express the high desire to eat in the overall scale and sub-dimensions (Cepeda-Benito et al., 2000 and Müftüoğlu, 2016). **Measure:** Evaluation of Eating Behaviour of the Study **Time Frame:** At baseline and At the end of 8th week #### Primary Outcomes **Description:** Hamilton Depression Rating Scale (HDRS): The HDRS focuses more on melancholic and physical symptoms of depression. In the HDRS, which consists of twenty-one questions, a score is calculated by answering 17 questions. The items of the scale related to difficulty falling asleep, waking up in the middle of the night, waking up early in the morning, somatic symptoms, genital symptoms, weakening and insight are graded between "0-2" and the other items are graded between "0-4". In the scale; 0-7 points: "no depression", 8-17 points: "mild depression", 18-24 points: "moderate depression" and \>23 points: "severe depression". **Measure:** Results of Clinical Findings **Time Frame:** At baseline, At the end of 4th week and At the end of 8th week **Description:** Depression Anxiety Stress Scale-21 (DASS-21): Depression Anxiety Stress Scale-21 consists of a total of 21 items aiming to measure depression, anxiety and stress levels. An individual's score of 5 points or more from the depression sub-dimension, 4 points or more from anxiety, and 8 points or more from stress indicates that he/she has the related problem. **Measure:** Results of Clinical Findings **Time Frame:** At baseline, At the end of 4th week and At the end of 8th week #### Secondary Outcomes **Description:** Biochemical Outcome: Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) Alkaline phosphatase (ALP), Gamma-glutamyltransferase (GGT), Glucose, HbA1c, Blood urea nitrogen (BUN), Creatine, Uric acid, Total cholesterol (Total-c), Triglycerides, Low density lipoprotein (LDL)-c, High density lipoprotein (HDL-c), Sodium (Na), Potassium (K), Calcium (Ca), Iron (Fe), Iron binding capacity (IBC) **Measure:** Biochemical Outcomes **Time Frame:** At baseline and At the end of 8th week **Description:** Anthropometric Measurements: Height (cm) will be measured with a non-flexible tape measure while standing in the frankfort plane (feet side by side with the heel and occipital region touching the wall). The body fat percentage (%), body lean mass (kg) and body fluid (%) of the individuals will be determined via a body analyzer. **Measure:** Height **Time Frame:** At baseline, At the end of 4th week and At the end of 8th week **Description:** 24-hour dietary record **Measure:** Dietary Intake **Time Frame:** At baseline and At the end of 8th week **Description:** In the study, body weight (kg) measurements of the individuals participating will be measured by the researcher. **Measure:** Body weight **Time Frame:** At baseline, At the end of 4th week and At the end of 8th week **Description:** Body mass index (kg/m2) will be calculated by dividing the square of height by body weight. **Measure:** BMI **Time Frame:** At baseline, At the end of 4th week and At the end of 8th week ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Between the ages of 19-65 years * To be diagnosed with major depression by a psychiatrist in accordance with DSM V diagnostic criteria * Not taking antidepressant medication or being on antidepressant medication for the last 1 month without medication change * To have signed the informed voluntary consent form. Exclusion Criteria: * More than two antidepressants * Substance users in the last 6 months * Those with alcohol addiction * Suicidal ideation and suicidal behaviour (followed up by clinicians) * Presence of other psychiatric disorders such as psychosis, schizophrenia and bipolar (except dysthymia and anxiety) * Presence of serious chronic diseases * Women during pregnancy or lactation * People taking medication that may cause emotional symptoms (Escitoloprom/Lexopro etc.) * Food allergy * Individuals at high risk of bleeding or taking anti-coagulant medication such as warfarin * Consuming 3 portions of fish or more per week * Use of any nutritional supplements * People with hypercholesterolaemia or taking medication for hypercholesterolaemia **Maximum Age:** 64 Years **Minimum Age:** 19 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Adıyaman **Country:** Turkey **Facility:** Adıyaman University Training and Research Hospital ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## 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: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depression - ID: M7060 - Name: Depressive Disorder, Major - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003863 - Term: Depression - ID: D000003866 - Term: Depressive Disorder ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414213 **Acronym:** ELLMITS **Brief Title:** Improving Locomotor Learning With Brain Stimulation **Official Title:** Enhancing Locomotor Learning With Motor Imagery and Transcranial Direct Current Stimulation #### Organization Study ID Info **ID:** IRB-21-0198 #### Organization **Class:** OTHER **Full Name:** Appalachian State University ### Status Module #### Completion Date **Date:** 2022-12-22 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-12-22 **Type:** ACTUAL #### Start Date **Date:** 2022-09-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Appalachian State University #### Responsible Party **Investigator Affiliation:** Appalachian State University **Investigator Full Name:** Jared Skinner **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The primary goal of this research was to assess the practicality and initial effectiveness of a motor imagery (MI) intervention combined with elements of action observation (AO), alongside active or sham transcranial direct current stimulation (tDCS) over the prefrontal cortex (PFC), on locomotor learning in healthy adults. Feasibility was determined by examining recruitment rates, participant engagement, and safety measures. The efficacy of the intervention was gauged by analyzing the time taken to complete tasks and changes in cerebral blood flow immediately after the intervention and one week later. The study was guided by three main hypotheses: (1) the intervention techniques would be well-received and safe for the participants; (2) compared to a control group, MI training would lead to better learning outcomes and retention of learning; (3) in comparison to the control and sham tDCS groups, active tDCS would result in superior learning outcomes and retention of learning. **Detailed Description:** The study implemented a double-blind, randomized, controlled trial design. Participants were tested three times over 7 days. After study enrollment, the participants were randomly assigned to one of three groups: MIActive (receiving active tDCS stimulation and participating in MI protocol), MISham (receiving sham tDCS stimulation and participating in MI protocol), and Control (receiving no stimulation and participating in an unrelated video-watching task) by a research member not associated with data collection. Allocation ratio was 1:1:1 and a block randomization approach was employed to maintain an equal distribution of participants across the three groups throughout the study. Study participants and assessors were blinded to assignment of active or sham tDCS. The independent variables were time (pre, post, and retention trials) and group (MIActive, MISham and Control), and the dependent variables were time to completion of a complex obstacle course and the amount of change in oxygenated hemoglobin (ΔO2Hb) during performance of that task. ### Conditions Module **Conditions:** - Motor Learning **Keywords:** - randomized - double-blinded - tDCS - motor imagery - functional near-infrared spectroscopy (fNIRS) - controlled trial ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 38 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The participants received active tDCS current and participated in the Motor Imagery intervention. **Intervention Names:** - Behavioral: Motor Imagery (MI) - Device: Active tDCS **Label:** MI/Active tDCS **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The participants received sham tDCS current and participated in the Motor Imagery intervention. **Intervention Names:** - Behavioral: Motor Imagery (MI) - Device: Sham tDCS **Label:** MI/Sham tDCS **Type:** SHAM_COMPARATOR #### Arm Group 3 **Description:** The control group watched an unrelated (non stimulating) video for a duration equal to the MI groups' intervention tasks. **Label:** Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - MI/Active tDCS - MI/Sham tDCS **Description:** Participants watched a standardized video sequence that consisted of an individual completing twenty walking trials (twenty video clips-each clip represents one trial). Participants were instructed to place their focus intently on the person performing the obstacle course and try to imagine themselves doing the skill. Periodically, a reminder would appear to help focus and redirect participant's attention to different aspects of the video or different versions of imagery (visual or kinesthetic). Participants will watch the video first at normal play speed and then in slow motion after a short break (30 secs to 1 min). Total training time will be approximately 20 mins which is consistent with the duration of the locomotor intervention and duration of stimulation. **Name:** Motor Imagery (MI) **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - MI/Active tDCS **Description:** The participants received a 20-minute "active" session of tDCS at a 2-milliamp current. **Name:** Active tDCS **Type:** DEVICE #### Intervention 3 **Arm Group Labels:** - MI/Sham tDCS **Description:** The participants received a 20-minute session of "sham" tDCS. **Name:** Sham tDCS **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Functional near infrared spectroscopy (fNIRS) monitor (OctaMon by Artinis Medical Systems), changes in oxygenated hemoglobin concentration (O2Hb) relative to a baseline task **Measure:** Prefrontal cortical activity **Time Frame:** Baseline to 1 week follow up **Description:** number of sessions attended **Measure:** Adherence to interventions **Time Frame:** Baseline to 1 week follow up **Description:** number of participants completing intervention and follow-up assessment **Measure:** Retention of participants **Time Frame:** Baseline to 1 week follow up **Description:** Number of unexpected and/or serious adverse events **Measure:** Adverse events in each study arm **Time Frame:** Baseline to 1 week follow up **Description:** Recorded time to complete the obstacle course **Measure:** Time to completion **Time Frame:** Baseline to 1 week follow up **Description:** Gait velocity, measured in meters/sec, was recorded using a zeno walkway gait analysis system. ProtoKinetics Movement Analysis Software was used to collect and analyze the data. **Measure:** Gait velocity **Time Frame:** Baseline to 1 week follow up #### Secondary Outcomes **Description:** The Montreal Cognitive Assessment (MoCA) is a widely used screening tool designed to assess various cognitive domains, including memory, attention, language, visuospatial skills, executive function, and orientation. During a MoCA test, individuals are presented with a series of tasks and questions that challenge different aspects of cognitive function. These tasks may include remembering a list of words, drawing a certain shape, following complex instructions, and identifying similarities between words or objects. **Measure:** Cognitive Assessment **Time Frame:** Baseline to 1 week follow up **Description:** The ability to imagine movements was assessed with the Kinesthetic and Visual Imagery Questionnaire (KVIQ). This test evaluates the subject's ability to see (visual imagery) and feel (kinesthetic imagery) movements. The KVIQ consists of 10 items, (5 movements for each scale), each item being a separate movement followed by rating the ease or difficulty of generating those self-images on a 5-point Likert scale (where 1 = no image or sensation and 5 = Image as clear as seeing or as intense as executing the action). Higher scores reflected higher imagery abilities. **Measure:** Kinesthetic and Visual Imagery Questionnaire (KVIQ) **Time Frame:** Baseline to 1 week follow up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male and female adults age 18 and older * Freely ambulatory (no assistive walking aids) Exclusion Criteria: * Failure to meet specific inclusion criteria * History or presence of any neurological disease * Low visual ability, operationally defined as visual acuity less than 20/70 on the standard eye chart * Extreme difficulty performing walking tasks due to low visual ability * Clinical judgment of the investigative team * Additionally, subjects who are determined to be at increased risk for adverse events during the tDCS procedure, as determined by the tDCS screening questionnaire **Healthy Volunteers:** True **Maximum Age:** 99 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Boone **Country:** United States **Facility:** Appalachian State University **State:** North Carolina **Zip:** 28607 #### Overall Officials **Official 1:** **Affiliation:** Appalachian State University **Name:** Jared W Skinner, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** There is not a plan to make Individual Participant Data (IPD) available. **IPD Sharing:** NO ### References Module #### References **Citation:** Clark DJ, Chatterjee SA, Skinner JW, Lysne PE, Sumonthee C, Wu SS, Cohen RA, Rose DK, Woods AJ. Combining Frontal Transcranial Direct Current Stimulation With Walking Rehabilitation to Enhance Mobility and Executive Function: A Pilot Clinical Trial. Neuromodulation. 2021 Jul;24(5):950-959. doi: 10.1111/ner.13250. Epub 2020 Aug 18. **PMID:** 32808403 ## Derived Section ### Misc Info Module #### Submission Tracking - Estimated Results First Submit Date: 2024-05-22 ##### Submission Infos - MCP Release N: Unknown - Release Date: 2024-05-22 - Reset Date: Unknown - Unrelease Date: Unknown - Unrelease Date Unknown: Unknown - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414200 **Acronym:** NutriCAD **Brief Title:** Nutritional Care After Discharge in Children Term Born-18years Old **Official Title:** Nutritional Care After Hospital Discharge #### Organization Study ID Info **ID:** NL84484.078.23 #### Organization **Class:** OTHER **Full Name:** Erasmus Medical Center ### Status Module #### Completion Date **Date:** 2027-03-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-03-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-12-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-02 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Erasmus Medical Center #### Responsible Party **Investigator Affiliation:** Erasmus Medical Center **Investigator Full Name:** S.C.A.T Verbruggen **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 stepped wedge cluster randomized trial is to compare nutritional care after discharge to an intervention in children term born - 18 years old discharged with newly initiated nutritional care. The main question it aims to answer is: To investigate whether a tailored nutritional care follow-up program in children who are being discharged from the hospital with nutritional support improves nutritional intake and status as well as feeding behavior and quality of life (QoL) in children and their parents. Furthermore, the effect on parental stress, anxiety, depression, and post-traumatic stress (PTSD) as well as QoL will be assessed with and without a tailored nutritional care follow-up program **Detailed Description:** All subjects, both in the usual care and intervention group, will be treated with the standard nutritional protocols of these individual hospitals during hospitalization. After hospital discharge, the treatments of the intervention and the control group will entail the procedures as described below. Intervention group The intervention consists of a tailored nutritional follow-up plan, including a parent empowerment program, made by a multidisciplinary support team (primarily responsible clinician, dietician, psychologist and, if indicated, a speech therapist). At discharge and follow-up at 6, 12 and 18 weeks after discharge, food diaries (including growth) and questionnaires\* relating to feeding behaviour and parental stress are filled out by parents/caregivers. One week before the planned outpatient visit of the patient and their parents, questionnaires will be sent with preferred software available in ErasmusMC ICT infrastructure through e-mail. The findings gathered from these nutritional data and questionnaires will be visualized on a dashboard (visible to parents and the caregivers) to discuss and help resolve the most relevant problems with the parents during the follow-up moments. During the outpatient visit, the growth and body composition of the child will also be assessed. The nutritional support team will discuss the outcomes of the questionnaires and make tailored advice based on the problems parents have reported. The dietician will discuss this tailored advice with the children and/or parents based on the growth, the nutritional intake of the child, and the problems parents have reported regarding the feeding behaviour of the child and their parental distress. Subsequently, the dietician will provide recommendations and psychoeducation to parents and/or patients in order to improve the nutritional status. At 6 months after discharge follow/up measurements such as, growth, duration and frequency of nutritional support, food diary, feeding behaviour of the child, QoL of the child, parental stress and QoL will be gathered. Evaluation and treatment other than follow-up at 6, 8 and 12 weeks after discharge with one of the health care professionals are on indication and data will not be collected. The intervention differs from the usual care, because follow-up is at standard time periods. In the usual care this is not regulated. Nutritional support is given in a multidisciplinary team including a psychologist, but in the pilot study we saw collaboration with the pediatrician and speech therapist only. In the intervention we also focuses on parenteral stress, which is new and different from usual care. Usual care group Nutritional advice in the usual care group will be given after discharge and follow-up according to standard practices. At 6 months after discharge an evaluation will be done equal to the intervention group. To collect information about the number of readmissions to the hospital and reason of admission, visits to a health-care provider, and growth parameters parents are asked to fill in a logbook to collect this data between discharge and 6 months follow-up. This method has been chosen because these are parameters that are difficult to remember at the visit 6 months after discharge. \*The following age-adjusted and validated questionnaires will be used to assess emotional functioning, the pediatric feeding disorders, and parenteral stress: ### Conditions Module **Conditions:** - Malnutrition, Child **Keywords:** - Nutritional care - After discharge - Pediatric ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** Multicentre study. It will be executed in an academic and five non-academic hospitals throughout The Netherlands. Due to the nature of the intervention, which involves changes to the provision of care and interaction between participants, there is a risk of cross-contamination within centers. Therefore, to avoid contamination of current practice, the stepped wedge cluster randomized controlled trial design was selected. This implies that all participating centers ('clusters') start with standard care (usual care). Subsequently, randomization will determine in which order the centers will begin with the NutriCAD intervention. In the end, all centers will have crossed over to be exposed to the NutriCAD intervention ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 260 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The usual care as given at that moment in that hospital. The group to compare the intervention with. **Label:** Control group/usual care group **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** The intervention consists of a tailored nutritional follow-up plan, including a parent empowerment program, made by a multidisciplinary support team (primarily responsible clinician, dietician, psychologist and, if indicated, a speech therapist). At discharge and follow-up at 6, 12 and 18 weeks after discharge, food diaries (including growth) and questionnaires\* relating to feeding behaviour and parental stress are filled out by parents/caregivers. **Intervention Names:** - Other: multidisciplinary structured tailored made nutritional advice **Label:** Intervention group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention group **Description:** The goal is a structured follow-up after discharge. Parents need to fill in questionnaires about eating behavior en feeding difficulties about their child. They also need to fill in a questionnaire about their stress. Together with their nutritional intake (3-days food diary) and growth a tailor-made nutritional plan is made. All the information I showed in a dashboard and discussed it with their dietitian. Who discusses this information in a multi-disciplinary team (pediatrician, psychologist and if needed a speech therapist). **Name:** multidisciplinary structured tailored made nutritional advice **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** in kilograms and z-scores **Measure:** Weigth **Time Frame:** From enrollment until 6 months after discharge **Description:** in meters and z-scores **Measure:** Height **Time Frame:** From enrollment until 6 months after discharge **Description:** in centimeters and z-scores **Measure:** Head circumference **Time Frame:** From enrollment until 6 months after discharge **Description:** in centimeters and z-scores **Measure:** Mid-upper arm circumference **Time Frame:** From enrollment until 6 months after discharge **Description:** in centimeters and z-scores **Measure:** Length in children <2 years of age **Time Frame:** From enrollment until 6 months after discharge #### Secondary Outcomes **Description:** Fat mass, Fat free mass **Measure:** Body composition **Time Frame:** From enrollment until 6 months after discharge **Description:** Time (weeks), frequency per day **Measure:** Duration and frequency of nutritional support **Time Frame:** From enrollment until 6 months after discharge **Description:** Yes/No and intermitted or portions **Measure:** Dependency on nasogastric tube feeding **Time Frame:** From enrollment until 6 months after discharge **Description:** Energy as kcal/day and kcal/kg **Measure:** Nutritional requirements and intake **Time Frame:** From enrollment until 6 months after discharge **Description:** Protein as gram/day and gram/kg **Measure:** Nutritional requirements and intake **Time Frame:** From enrollment until 6 months after discharge **Description:** Fluids as ml/day and ml/kg **Measure:** Nutritional requirements and intake **Time Frame:** From enrollment until 6 months after discharge **Description:** Total mineral an vitamin intake percentage of ADH **Measure:** Nutritional requirements and intake **Time Frame:** From enrollment until 6 months after discharge **Description:** Questionnnaire CEBQ/BEBQ **Measure:** Feeding behaviour of the child **Time Frame:** From enrollment until 6 months after discharge **Description:** Questionnnaire MCH-FS **Measure:** Feeding behaviour of the child **Time Frame:** From enrollment until 6 months after discharge **Description:** Questionnaire LTO **Measure:** Parental stress **Time Frame:** From enrollment until 6 months after discharge **Description:** Questionnaire PROMIS **Measure:** Parental stress **Time Frame:** From enrollment until 6 months after discharge **Description:** Questionnaire CHU9D **Measure:** Quality of Life of children and parents **Time Frame:** From enrollment until 6 months after discharge **Description:** Questionnaire iMCQ **Measure:** Cost-effectiveness of tailored nutritional care **Time Frame:** From enrollment until 6 months after discharge **Description:** Questionnaire iPCQ **Measure:** Cost-effectiveness of tailored nutritional care **Time Frame:** From enrollment until 6 months after discharge **Description:** Interviews with parents **Measure:** Barriers and facilitators of implementation of the multidisciplinary support team **Time Frame:** From enrollment until 6 months after discharge ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Children term born neonates till 18 years old * Admitted with newly initiated nutritional support(oral and/or enteral nutritional support) during hospitalization * Nutritional Support continues at home after discharge. Exclusion Criteria: * Children with existing nutritional support upon admission * Children in need of parenteral nutrition at discharge * Children with DSM-5 diagnosed feeding disorders such as anorexia * Absence of written informed consent **Maximum Age:** 18 Years **Minimum Age:** 7 Days **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** e.vansteenbergen@erasmusmc.nl **Name:** Esther J van Steenbergen, Msc **Phone:** +31107030380 **Role:** CONTACT #### Locations **Location 1:** **City:** Rotterdam **Contacts:** ***Contact 1:*** - **Email:** e.vansteenbergen@erasmusmc.nl - **Name:** Esther J van Steenbergen, Msc - **Phone:** +31611759908 - **Role:** CONTACT ***Contact 2:*** - **Name:** Sascha C Verbruggen, dr. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Netherlands **Facility:** ErasmusMC **State:** Zuid-Holland **Zip:** 3015 CN #### Overall Officials **Official 1:** **Affiliation:** Erasmus Medical Center **Name:** Sascha C Verbruggen **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009748 - Term: Nutrition Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M25306 - Name: Malnutrition - Relevance: HIGH - As Found: Malnutrition - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: M18049 - Name: Child Nutrition Disorders - Relevance: HIGH - As Found: Malnutrition, Child ### Condition Browse Module - Meshes - ID: D000044342 - Term: Malnutrition - ID: D000015362 - Term: Child Nutrition Disorders ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414187 **Acronym:** IABP ON-TIME **Brief Title:** Clinical Effects of Intra-aortic Balloon Support in Early Acute Coronary Syndrome and Non-Acute Coronary Syndrome Related Cardiogenic Shock **Official Title:** Clinical Effects of Intra-aortic Balloon Support in Early Acute Coronary Syndrome and Non-Acute Coronary Syndrome Related Cardiogenic Shock: a Multicenter Randomized Controlled Trial #### Organization Study ID Info **ID:** IABP ON-TIME #### Organization **Class:** OTHER **Full Name:** Erasmus Medical Center ### Status Module #### Completion Date **Date:** 2027-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-01-03 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Arrow International LCC (Subsidiary of Teleflex Inc.) #### Lead Sponsor **Class:** OTHER **Name:** Erasmus Medical Center #### Responsible Party **Investigator Affiliation:** Erasmus Medical Center **Investigator Full Name:** Nicolas van Mieghem **Investigator Title:** Chair, Full Professional, Clinical Director of Interventional Cardiology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this randomized controlled trial is to appraise the impact of intra-aortic balloon pump (IABP) in the treatment of early stages of cardiogenic shock, irrespective of etiology. Findings of this randomized trial may enhance clinical decision making regarding the use of MCS in specific subsets of patients in early stages of cardiogenic shock. The main questions it aims to answer are: * What are the effects of IABP on a composite of clinical endpoints representing clinical deterioration at 30-days in patients presenting with SCAI stage B or C cardiogenic shock? * What is the 1-year clinical outcome (including mortality and hospital admissions for cardiovascular causes) of patients treated with vs. without IABP for early cardiogenic shock? * Is there a difference in efficacy of IABP within the treatment of early cardiogenic shock related to Acute Coronary Syndrome versus non-ischemic causes? * Is there a difference in efficacy of IABP within the treatment of SCAI stage B versus stage C cardiogenic shock? Participants will be 1:1 randomized to IABP support or standard of care (a treatment strategy including inotropes and/or vasopressors but no IABP insertion). Patients will be stratified for Acute Coronary Syndrome/non-ischemic etiology and stage B/stage C cardiogenic shock, following stratification to center. Researchers will compare the group who was randomized to IABP to the control group (i.e. standard of care) to see if there is a difference in the primary trial endpoint after 30-days, including 1) all-cause mortality, 2) escalation to invasive mechanical ventilation, 3) escalation of mechanical circulatory support strategy, 4) acute kidney injury and 5) stroke or transient ischemic attack. **Detailed Description:** Rationale: The scientific underpinning for the use of mechanical circulatory support (MCS) in early cardiogenic shock, especially for the intra-aortic balloon pump (IABP), is scarce and insufficiently clarified for different etiologies of cardiogenic shock. Previous randomized trials limited the inclusion criteria to patients with ischemic cardiogenic shock while observational research suggested favorable effects of timely adoption of IABP in patients with deteriorating myocardial function through ischemic or non-ischemic causes. Early stage of cardiogenic shock is defined by relative hypotension without hypoperfusion, or hypoperfusion still responsive to therapy (Society for Cardiovascular Angiography and Interventions, SCAI, stage B and C, respectively). A tightening of global guidelines with respect to the clinical adoption of IABP overshadowed the potential beneficial effects for specific patient categories within the total spectrum of cardiogenic shock. Patients currently presenting with early stages of cardiogenic shock caused by ischemic or non-ischemic etiology are hypothetically undertreated due to an assumed lack of clinical benefit of IABP in general. The aim of this randomized trial is to appraise the impact of IABP in the treatment of early stages of cardiogenic shock, irrespective of etiology. Findings of this randomized trial may enhance clinical decision making regarding the use of MCS in specific subsets of patients in early stages of cardiogenic shock. Objective: The primary objective of this trial is to evaluate the 30-day clinical impact of IABP within the treatment of early (SCAI stage B or C) cardiogenic shock. Secondary objectives are 1) To evaluate the 1-year clinical outcome (including mortality and hospital admissions for cardiovascular causes) of patients treated with IABP for early cardiogenic shock; 2) To identify differences in efficacy of IABP in the treatment of early cardiogenic shock related to Acute Coronary Syndrome (ACS) versus non-ischemic causes; 3) To explore differences in efficacy of IABP in the treatment of stage B versus stage C cardiogenic shock. Trial design: Open-label, multicenter, investigator-initiated, randomized controlled trial. Trial population: The trial population consists of patients in early cardiogenic shock, defined as SCAI stage B or C, either related or unrelated to ACS. Intervention: Patients enrolled in this trial will be 1:1 randomized to IABP support or standard of care (i.e. inotropes and/or vasopressors but no IABP insertion). Patients will be stratified for ACS/non-ischemic etiology and stage B/stage C cardiogenic shock following stratification according to center. ### Conditions Module **Conditions:** - Cardiogenic Shock **Keywords:** - Intra-aortic balloon pump - Mechanical circulatory support - Acute coronary syndrome - Ischemic cardiogenic shock - Non-ischemic cardiogenic shock - Cardiogenic shock - Decompensated heart failure ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Patients enrolled in this trial will be 1:1 randomized to IABP support or standard of care (i.e. inotropes and/or vasopressors, but no IABP insertion). Patients will be stratified for ACS/non-ischemic etiology and stage B/stage C cardiogenic shock following stratification according to center. ##### Masking Info **Masking:** TRIPLE **Masking Description:** Given the nature of percutaneous IABP support a double-blind trial design is not feasible. Therefore, this trial is an open-label randomized clinical trial indicating both the patient, treating physicians as well as researchers are aware of the allocated treatment (i.e. with or without IABP). The Clinical Event Committee (CEC), responsible for adjudicating events belonging to e.g. the primary outcome, are blinded for the allocated treatment. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 400 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients assigned IABP therapy will undergo IABP insertion as promptly as possible, with a target interval from randomization to insertion of less than 30 minutes. Implantation of the IABP balloon can be established either in the cardiac catheterization laboratory or at bedside in the ICU or cardiac care unit. The steering committee of this trial recommends the use of an appropriate-sized IABP balloon according to the instructions for use. Low-dose vasopressors (noradrenaline/norepinephrine up to 0.2 ug/kg/min) are allowed next to IABP support. The necessity of increasing the noradrenaline/norepinephrine dose with at least 0.2 ug/kg/min or the necessity to initiate de-novo inotropic agents to reach a mean arterial blood pressure of at least 65 mmHg is considered treatment escalation. **Intervention Names:** - Device: Intra-Aortic Balloon Pump **Label:** IABP-arm **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** When a patient is randomized to the standard of care-arm, the definitive treatment strategy is up to the discretion of the treating physician (providing no IABP is inserted). The treatment strategy may include fluid management as well as administration of inotropes and vasopressors. The only imposed difference in treatment is the omission of IABP, as the dose of inotropes and vasopressors is not expected to be high in early cardiogenic shock. The final decision to escalate in the strategy of mechanical circulatory support (including to initiate IABP in the standard of care-arm) is up to the discretion of the treating physician. However, the steering committee feels escalation in MCS strategy is appropriate in case of persistent mean arterial pressure \<65 mmHg with incessant lactate levels \>5.0 mmol/L when pharmacologic support was already intensified (e.g. the noradrenaline/norepinephrine dose exceeds 0.2 ug/kg/min or inotropic support was already administered). **Label:** Standard of care-arm **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - IABP-arm **Description:** Patients who are randomized to the IABP-arm will be supported with IABP according to local, clinical guidelines (including algorithms for anticoagulation, verification of correct positioning and weaning strategies). The IABP console and disposables should be used according to the instructions for use, including the use of an appropriate-sized IABP balloon alligned with patient length and height. **Name:** Intra-Aortic Balloon Pump **Type:** DEVICE ### Outcomes Module #### Other Outcomes **Description:** Including presumed cause of death **Measure:** Mortality (percent) **Time Frame:** 30-day follow-up and 1-year follow-up **Description:** Stay after randomization **Measure:** Length of intensive care unit and hospital stay (in days) **Time Frame:** 30-day follow-up **Description:** After randomization **Measure:** Re-admission to the intensive care unit (percent) **Time Frame:** 30-day follow-up **Description:** After randomization **Measure:** Implantation of Left Ventricular Assist Device or heart transplant (percent) **Time Frame:** 30-day follow-up **Description:** Including percutaneous coronary intervention or coronary artery bypass graft **Measure:** Revascularization attempts (percent) **Time Frame:** 30-day follow-up **Description:** Including 1) all-cause mortality and 2) hospital admission because of cardiovascular disease **Measure:** 1-Year composite endpoint (percent) **Time Frame:** 1-year follow-up **Description:** See 1-Year composite endpoint (percent), including 1) all-cause mortality and 2) hospital admission because of cardiovascular disease. Based on details stated in the patient's record. **Measure:** All-cause mortality (i.e. the individual determinants of the 1-year composite endpoint) **Time Frame:** 1-year follow-up **Description:** See 1-Year composite endpoint (percent), including 1) all-cause mortality and 2) hospital admission because of cardiovascular disease. Based on details stated in the patient's record. **Measure:** Hospital admission because of cardiovascular disease (i.e. the individual determinants of the 1-year composite endpoint) **Time Frame:** 1-year follow-up **Description:** Including a description of the presumed cause of hospital (re-)admission **Measure:** Hospital re-admission (percent) **Time Frame:** 1-year follow-up **Description:** Of note, visits necessitating treatment escalation for heart failure **Measure:** Visits to the emergency department (percent) **Time Frame:** 1-year follow-up **Description:** Including details concerning the revascularization attempt (i.e. percutaneous coronary intervention or coronary artery bypass graft) **Measure:** Unplanned revascularization (percent) **Time Frame:** 1-year follow-up #### Primary Outcomes **Description:** The primary endpoint of the trial is the composite of the following outcomes: 1) all-cause mortality, 2) escalation to invasive mechanical ventilation, 3) escalation of mechanical circulatory support, 4) acute kidney injury and 5) stroke or transient ischemic attack. **Measure:** Composite primary endpoint (percent) **Time Frame:** 30-days post enrollment #### Secondary Outcomes **Description:** See primary outcome (%) (based on details stated in patient's records) **Measure:** All-cause mortality (i.e. the individual determinants of the composite primary outcome) (percent) **Time Frame:** 30-day follow-up **Description:** See primary outcome (%) (based on details stated in patient's records) **Measure:** Escalation to invasive mechanical ventilation (i.e. the individual determinants of the composite primary outcome **Time Frame:** 30-day follow-up **Description:** See primary outcome (%) (based on details stated in patient's records) **Measure:** Escalation to mechanical circulatory support (i.e. the individual determinants of the composite primary outcome) **Time Frame:** 30-day follow-up **Description:** See primary outcome (%) (based on details stated in patient's records) **Measure:** Acute kidney injury (i.e. the individual determinants of the primary outcome) **Time Frame:** 30-day follow-up **Description:** See primary outcome (%) (based on details stated in patient's records) **Measure:** Stroke or transient ischemic attack (i.e. the individual determinants of the primary outcome) **Time Frame:** 30-day follow-up **Description:** Any steps in noradrenaline increase at least 0.2 ug/kg/min, or intensifying inotropic treatment (i.e. dose increasing or initiation of new agents) are considered treatment escalation, irrespective of trial arm. Uptitration of noradrenaline up to 0.2 ug/kg/min is considered standard of care. Treatment escalation also includes the initiation of MCS (including the institution of IABP in the standard of care-arm or escalation to e.g. continuous flow or extracorporeal mechanical circulatory support in the IABP-arm). **Measure:** Treatment escalation (percent) **Time Frame:** 30-day follow-up **Description:** If the patient entered the trial meeting criteria for SCAI stage B **Measure:** Deterioration of SCAI stage B to C (percent) **Time Frame:** 30-day follow-up **Description:** Degradation to SCAI stage D or E **Measure:** Deterioration of cardiogenic shock (percent) **Time Frame:** at 7 and 14 days after randomization **Description:** Following randomization to the IABP-arm, specifying major and minor vascular complications as well as major and minor access-related non-vascular complications **Measure:** Vascular complications defined according to VARC-3 guidelines (percent) **Time Frame:** 30-day follow-up **Description:** Following randomization to the IABP-arm **Measure:** Major bleeding complications defined according to BARC guidelines (at least type 2) (percent) **Time Frame:** 30-day follow-up **Description:** i.e. type 1 myocardial infarction **Measure:** De-novo Acute Coronary Syndrome (percent) **Time Frame:** 30-day and 1-year follow-up **Description:** Including an appropriate shock of an Implantable Cardioverter Defibrillator **Measure:** Cardiopulmonary resuscitation or defibrillation (percent) **Time Frame:** 30-day follow-up **Description:** Defined according to the Surviving Sepsis Guidelines **Measure:** Development of SIRS, sepsis or severe sepsis (percent) **Time Frame:** 96-hours after randomization ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * At least 18 years of age; * Stage B cardiogenic shock (presence of hypotension or tachycardia with signs of venous congestion, in absence of tissue hypoperfusion) OR * Stage C cardiogenic shock (evidence of tissue hypoperfusion requiring any intervention beyond fluid management, still responsive to therapy) AND * Must include at least one of the following: 1) lactate levels at least 2.0 mmol/L; 2) creatinine doubling OR \>50 percent decline in glomerular filtration rate compared to baseline; 3) laboratory markers indicating liver injury (e.g. high serum transaminase levels) or 4) elevated NT-pro BNP. A patient is eligible for trial inclusion if, at the time of randomization, no more than 1 inotropic agent has been administered AND when the maximum dose of noradrenaline/norepinephrine has not exceeded 0.2 ug/kg/min in the context of mean arterial pressure \>65 mmHg. Exclusion Criteria: * The patient is in cardiogenic shock but does not fulfill the definition for stage B or C; * Administration of at least 2 inotropic or vasopressive agents at study randomization; * Administration of noradrenaline/norepinephrine exceeding 0.2 ug/kg/min at study randomization; * Suspected or known mechanical complication contributing to cardiogenic shock, e.g. ventricular septal defect or papillary muscle rupture; * Cardiogenic shock developing within 72 hours of a surgical procedure (i.e. low cardiac output with an inability to wean cardiopulmonary bypass); * Inability to provide informed consent. Of not: patients admitted in cardiogenic shock who required cardiopulmonary resuscitation earlier, but are conscious at the time of hospital admission, are eligible for study participation; * Known or suspected insufficiency of the aortic valve with at least moderate aortic regurgitation; * Known or suspected peripheral arterial disease preventing safe insertion of IABP; * Known or suspected thoracic or abdominal aortic disease (including aortic dissection or aortic aneurysm) precluding safe insertion of IABP; * Suspicion of sepsis or septic shock (including septic cardiomyopathy); * Pregnancy; * Predicted life expectancy \<6 months because of concomitant disease; * Concurrent participation in a clinical trial with competing endpoints. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** a.vandenenden@erasmusmc.nl **Name:** Antoon JM van den Enden, MD **Phone:** +31 10 7038896 **Role:** CONTACT #### Locations **Location 1:** **City:** Rotterdam **Contacts:** ***Contact 1:*** - **Email:** a.vandenenden@erasmusmc.nl - **Name:** Antoon JM van den Enden - **Phone:** +31 70 308896 - **Role:** CONTACT ***Contact 2:*** - **Name:** Nicolas M Van Mieghem, Prof MD PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Christiaan L. Meuwese, MD PhD - **Role:** SUB_INVESTIGATOR **Country:** Netherlands **Facility:** Erasmus University Medical Center **State:** Zuid-Holland **Zip:** 3000 CA #### Overall Officials **Official 1:** **Affiliation:** Erasmus Medical Center **Name:** Nicolas M Van Mieghem, Prof MD PhD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000017202 - Term: Myocardial Ischemia - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000009203 - Term: Myocardial Infarction - ID: D000007238 - Term: Infarction - ID: D000007511 - Term: Ischemia - ID: D000009336 - Term: Necrosis ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15577 - Name: Shock - Relevance: HIGH - As Found: Shock - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M27545 - Name: Acute Coronary Syndrome - Relevance: HIGH - As Found: Acute Coronary Syndrome - ID: M9421 - Name: Heart Failure - Relevance: LOW - As Found: Unknown - ID: M15578 - Name: Shock, Cardiogenic - Relevance: HIGH - As Found: Cardiogenic Shock - 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: M12155 - Name: Myocardial Infarction - Relevance: LOW - As Found: Unknown - ID: M10282 - Name: Infarction - Relevance: LOW - As Found: Unknown - ID: M12284 - Name: Necrosis - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000054058 - Term: Acute Coronary Syndrome - ID: D000012770 - Term: Shock, Cardiogenic - ID: D000013577 - Term: Syndrome - ID: D000012769 - Term: Shock ### 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: LOW - As Found: Unknown - ID: M17409 - Name: Vasoconstrictor Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414174 **Brief Title:** Comparison Between Split Septum and Mechanical Valve Needleless Connector in Preterm Babies **Official Title:** Comparison Between Split Septum and Mechanical Valve Needleless Connector in Preventing Central Line-Associated Bloodstream Infections in Very Preterm Babies or Birth Weight <1500 Grams at Cipto Mangunkusumo Hospital Neonatology Unit #### Organization Study ID Info **ID:** NeedlelessInd #### Organization **Class:** OTHER **Full Name:** Indonesia University ### Status Module #### Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Indonesia University #### Responsible Party **Investigator Affiliation:** Indonesia University **Investigator Full Name:** Dr. dr. Putri Maharani Tristanita Marsubrin, Sp. A(K) **Investigator Title:** Neonatologist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this clinical trial study is to compare the effectiveness between split septum and mechanical valve needleless connector in very preterm babies (or under 1500 grams) The main questions it aims to answer are: * What is the incidence of Central Line-Associated Bloodstream Infections when using a split septum connector? * What is the incidence of Central Line-Associated Bloodstream Infections when using a mechanical valve connector? * What is the ratio length of stay between babies with birth weight \< 1500 grams who use split septum connector and mechanical valve? * What is the ratio incidence of mortality due to sepsis of babies with birth weight \< 1500 grams who use split septum connector and mechanical valve? Participants will be observed for two weeks after insertion of central line. They will be taken blood sample for culture and sepsis marker panel. Researchers will compare split septum group and mechanical valve group to see if there is a central line associated bloodstream infections ### Conditions Module **Conditions:** - Sepsis, Neonatal ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This study involves two group of participants to receive specific intervention. One of the group will be using split septum mechanism for their needleless connector, while the other group will use mechanical valve mechanism for their needleless connector. Both group will be assessed and monitored closely for the incidence of infection ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Very preterm neonates or birth weight \< 1500 gram who needs central line access will use split septum mechanism for their needleless connector **Intervention Names:** - Device: Split septum needleless connector **Label:** Very preterm neonates or birth weight < 1500 gram receiving split septum needleless connector **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Very preterm neonates or birth weight \< 1500 gram who needs central line access will use mechanical valve for their needleless connector **Intervention Names:** - Device: Mechanical valve needleless connector **Label:** Very preterm neonates or birth weight < 1500 gram receiving mechanical valve needleless connector **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Very preterm neonates or birth weight < 1500 gram receiving split septum needleless connector **Description:** Participants in this study are limited to very preterm neonates or neonates with birth weight under 1500 grams. Split septum mechanism is still widely use in Indonesia, therefore the use of mechanical valve mechanism as needleless connector for central line access in very preterm neonates have never been tested. **Name:** Split septum needleless connector **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Very preterm neonates or birth weight < 1500 gram receiving mechanical valve needleless connector **Description:** Participants in this study are limited to very preterm neonates or neonates with birth weight under 1500 grams. Split septum mechanism is still widely use in Indonesia, therefore the use of mechanical valve mechanism as needleless connector for central line access in very preterm neonates have never been tested. **Name:** Mechanical valve needleless connector **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The incidence of CLABSI are proven by clinical symptoms followed by positive blood culture taken at two different site, consist of peripheral and central site **Measure:** Incidence of Central Line Associated Bloodstream Infection (CLABSI) **Time Frame:** From the date of central line insertion until the date of documented infection, whichever came first, assessed up to 2 weeks #### Secondary Outcomes **Description:** The duration which the subject is hospitalized **Measure:** Length of stay **Time Frame:** From the date of central line insertion until the date of discharged, whichever came first, assessed up to 2 weeks **Description:** Incidence of death because of sepsis **Measure:** Death **Time Frame:** From the date of central line insertion until the date of death, whichever came first, assessed up to 2 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Preterm neonates with gestational age less than and equal to 32 weeks * Birth weight less than 1500 gram * Neonates indicated to use central line access * Parents are willing to participate in this study and has filled and signed the informed consent letter Exclusion Criteria: * Neonates who are previously diagnosed as CLABSI * Neonates who has other focus of infection that are diagnosed before the recruitment * Suffer from congenital abnormalities **Healthy Volunteers:** True **Maximum Age:** 32 Weeks **Minimum Age:** 28 Weeks **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** putristanita2806@yahoo.com **Name:** Putri Maharani Tristanita Marsubrin, Doctoral **Phone:** +62 8128126640 **Role:** CONTACT ### IPD Sharing Statement Module **Description:** The data will not be shared because of the confidentiality agreement stated in the informed consent form **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000018805 - Term: Sepsis - ID: D000007239 - Term: Infections - ID: D000007232 - Term: Infant, Newborn, Diseases - ID: D000018746 - Term: Systemic Inflammatory Response Syndrome - ID: D000007249 - Term: Inflammation - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M25869 - Name: Premature Birth - Relevance: LOW - As Found: Unknown - ID: M5006 - Name: Birth Weight - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown - ID: M20864 - Name: Sepsis - Relevance: LOW - As Found: Unknown - ID: M16869 - Name: Toxemia - Relevance: LOW - As Found: Unknown - ID: M696 - Name: Neonatal Sepsis - Relevance: HIGH - As Found: Sepsis, Neonatal - ID: M10276 - Name: Infant, Newborn, Diseases - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M20818 - Name: Systemic Inflammatory Response Syndrome - Relevance: LOW - As Found: Unknown - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000071074 - Term: Neonatal Sepsis ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414161 **Brief Title:** Management of Radiotherapy-related Xerostomia With Green Tea and Peppermint **Official Title:** Management of Radiotherapy-related Xerostomia With Green Tea and Peppermint Oral Rinse: a Double-blind, Randomized Clinical Trial #### Organization Study ID Info **ID:** green tea and peppermint #### Organization **Class:** OTHER **Full Name:** Ain Shams University ### Status Module #### Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-04-19 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ain Shams University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this study is to evaluate the clinical effectiveness of a mix of (green tea and peppermint) mouth rinse using the subjective dry mouth score as a primary objective and to assess the effect of that mix on the salivary flow rate and objective dry mouth score as a secondary objective. **Detailed Description:** The Global Cancer Observatory from the World Health Organization estimates that head and neck cancer (HNC) incidence will reach approximately 1.5 million cases worldwide in 2020. Nevertheless, radiotherapy (RT) remains one of the cornerstone standard therapies to attenuate HNC progression. The advancement of linear accelerator (LINAC) technologies together with intensity-modulated radiation therapy (IMRT) techniques have enhanced the precision and efficiency of fractionated RT for HNC. Emerging research efforts have also been undertaken to understand these RT technologies' ability to spare the function of neighboring healthy tissues or organs like the salivary glands (SG). Despite these research advances, a large majority of HNC patients who undergo RT display irreversible dry mouth symptoms (xerostomia) due to high radiation sensitivity of salivary gland (SG) secretory cells. This gland damage is thought to be triggered by an RT-induced loss of acinar cells and a potential impairment of the parasympathetic innervation and vascularization. Hence, the remaining integral SG stem/progenitor cells post-RT will define the true regenerative ability of the SG organ. Cytoprotectant agents like amifostine have been recommended to prevent RT damage to SG cells. Amifostine is the only US Food and Drug Administration (FDA) approved drug for this prevention strategy. In Phase III clinical trials, amifostine was found to reduce xerostomia severity in subjects with grade two and above; however, more than 50% of subjects still presented acute xerostomia symptoms and oral mucosa inflammation. Moreover, amifostine has a very narrow therapeutic window. Therefore, frequent administration is required leading to severe side effects in more than half of the treated individuals. These side effects can lead to the discontinuation of amifostine treatment and RT delay in 25% of HNC patients. The high frequency of reported side effects and its high cost and low-quality evidence of efficacy from several clinical trials make amifostine a less promising pharmacological approach. Thus, novel pharmaceuticals are necessary to prevent SG damage and maintain the acinar epithelial and stem/progenitor cell populations in the SG organ. In vitro and in vivo studies indicate green tea polyphenols (GTPs)/(-)-epigallocatechin-3-gallate (EGCG) as potential natural agents for xerostomia management, potentially delaying salivary dysfunction through molecular mechanisms. Researchers highlighted EGCG's role in suppressing autoantigens, influencing epithelial cell proliferation, and modulating antioxidant enzyme expression in salivary glands. Peppermint essential oil is another herbal preparation with strong antibacterial and cooling effects. As a safe herbal preparation, peppermint essential oil has been found to be effective in alleviating the pain associated with aphthous stomatitis and managing dental plaque. ### Conditions Module **Conditions:** - Radiation-induced Xerostomia **Keywords:** - xerostomia - green tea - pepprmint - Mucositis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** patients in test group will topically apply 20 ml (green tea plus peppermint) (1:1) to the oral mucosa. They will be instructed to keep green tea plus peppermint for at least 5 min duration and then to spit it out. They will be advised to rinse 20 mL of green tea plus peppermint in the same manner before sleeping from fourth week of radiotherapy to three months after radiotherapy. **Intervention Names:** - Dietary Supplement: mix of (green tea and peppermint) **Label:** Intervention group: **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients in the control arm will topically apply 20 mL of 0.9% of saline 15 min before and after radiotherapy. They will be advised to rinse saline. They will be instructed to keep saline for at least 5 min duration and then to spit it out. They will be advised to rinse 20 mL of saline in the same manner before sleeping from fourth week of radiotherapy to three months after radiotherapy. **Intervention Names:** - Dietary Supplement: mix of (green tea and peppermint) **Label:** Control group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Control group - Intervention group: **Description:** Dried green tea leaves (100 gm) will be soaked into 500 ml of methanol solution for two days. The solution obtained will then be strained by a strainer and shifted to a glass plate. The plates will be left at room temperature from three to four days. Scraping out of the crystal powder of the extract from the plates will be carried out \[27\]. The peppermint mouth rinse that was used in this study had 1% peppermint base, 10% xylisorb, 5% glycerin, 1% Tween 20%, 5% alcohol 96%, 0/18% methyl paraben, and 0/02% propyl paraben \[28\]. Similarly, green tea plus peppermint mouthwash will be prepared at the same way but by adding 50% green tea leaves and 50% peppermint in the extract. **Name:** mix of (green tea and peppermint) **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Using a questionnaire will be recorded according to the following: Q1. Does your mouth feel dry? Q2. Do you sip liquids to aid in swallowing dry food? Q3. Does your mouth feel dry when eating a meal? Q4. Does the amount of saliva in your mouth seem to be too little? Subject who answered affirmatively to at least one of the questions related to oral dryness will be considered as positive for subjective complaints of oral dryness. the score range frpm 1-4 according to the number of questions answered by yes **Measure:** Subjective symptoms of oral dryness **Time Frame:** Three points: -"baseline which is at the fourth week of radiotherapy", -"the second point is at seventh week of the radiotherapy, while the end point is after three months of radiotherapy. #### Secondary Outcomes **Description:** • The patients will be examined for their signs of dry mouth including: (Osailan et al., 2011). 1. loss of pooled saliva 2. Mouth mirror stickiness 3. Stringy or foamy appearance 4. Labial dehydration 5. Irresponsiveness to parotid stimulation • Objective dry mouth scores will be calculated as the number of observed dry mouth signs (0-5), and patients with a score less than 2 will be excluded. **Measure:** Objective dry mouth score **Time Frame:** Three points: -"baseline which is at the fourth week of radiotherapy", -"the second point is at seventh week of the radiotherapy, while the end point is after three months of radiotherapy. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Both genders, aged above 20 years. * All patients must have complaint of xerostomia. * Objective dry mouth score from ( 2-5). * Subjective dry mouth score from (1-4). * Patients must be able to make reliable decision or communications. Exclusion Criteria: * - Smoking, Alcohol. * Patient with history of any serious illness as malignancy. * Patients with any autoimmune disease. * Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals. * Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation. **Maximum Age:** 70 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** fatmahassanein@dent.asu.edu.eg **Name:** Fatma E.Sayed A Hassanein **Phone:** +201000093885 **Role:** CONTACT **Contact 2:** **Email:** Asmaa.Aboubakr@bue.edu.eg **Name:** Asma A. Abou Bakr **Role:** CONTACT #### Locations **Location 1:** **City:** Cairo **Contacts:** ***Contact 1:*** - **Email:** fatmahassanein@dent.asu.edu.eg - **Name:** Fatma E.Sayed A Hassanein - **Phone:** +201000093885 - **Role:** CONTACT **Country:** Egypt **Facility:** Ahmed Maher Teaching Hosipital **Status:** RECRUITING **Zip:** 11565 **Location 2:** **City:** Cairo **Country:** Egypt **Facility:** ain shams University **Status:** COMPLETED **Zip:** 11565 #### Overall Officials **Official 1:** **Affiliation:** professor **Name:** dalia Ghalwash **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012466 - Term: Salivary Gland Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M17724 - Name: Xerostomia - Relevance: HIGH - As Found: Xerostomia - ID: M26955 - Name: Mucositis - Relevance: LOW - As Found: Unknown - ID: M15285 - Name: Salivary Gland Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014987 - Term: Xerostomia ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M3777 - Name: Ethanol - Relevance: LOW - As Found: Unknown - ID: T251 - Name: Peppermint - Relevance: HIGH - As Found: PDR - ID: T312 - Name: Tea - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414148 **Acronym:** EpLCART **Brief Title:** MRD-Directed Consolidation With Epcor-only or Epcor-R2 Post Anti-CD19 CAR TCell Therapy for Large B-Cell Lymphoma **Official Title:** A Phase II Open-Label, Multi-Centre Study of Minimal Residual Disease-Directed Consolidation With Epcoritamab or Epcoritamab-Lenalidomide-Rituximab Post Anti-CD19 CAR TCell Therapy for Large B-Cell Lymphoma (EpLCART) #### Organization Study ID Info **ID:** 22/012 #### Organization **Class:** OTHER **Full Name:** Peter MacCallum Cancer Centre, Australia ### Status Module #### Completion Date **Date:** 2028-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-04-29 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** AbbVie #### Lead Sponsor **Class:** OTHER **Name:** Peter MacCallum Cancer Centre, Australia #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a Phase II open-label, two-arm randomised non-comparative, multi-centre study to evaluate the efficacy of Epcor-only (Epcoritamab alone) or Epcor-R2 (Epcoritamab, lenalidomide and rituximab) as consolidation post anti-CD19 CAR T-cell therapy for patients that have responded by conventional criteria but who are at high risk of progression by virtue of being Minimal Residual Disease (MRD) positive as determined by a Circulating Tumour DNA (ctDNA) assay. **Detailed Description:** Patients who have received CAR T-cell therapy for Relapsed/Refractory Large B-Cell Lymphoma, are in Complete Metabolic Response (CMR) or Partial Metabolic Response (PMR) and MRD positive post CAR T-cell infusion are potentially eligible. Once these patients have provided their consent, they will enter the screening phase. All events of Cytokine Release Syndrome (CRS), Haemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS), Immune-Effector Cell Associated Neurologic Syndrome (ICANS), or infection must have completely resolved. Additionally, patients must have adequate organ and haematological function, and an ECOG performance status of up to 2. Patients deemed eligible for the study will be randomised to receive Epcor-only (Arm A) or Epcor-R2 (Arm B) for 6 cycles. The primary endpoint is CMR by Lugano 2014 criteria at month 12 post CAR T-cell infusion. Patients will undergo an interim response assessment after 2 cycles of treatment. Patients that complete the full 6 cycles of treatment or that discontinue treatment for any reason will have an End of Treatment visit and a Safety Follow-up visit at 60 days after Day 1 of Cycle 6. Patients with non-Progressive Disease (PD) then enter the follow-up phase of the study where they will undergo response assessments at month 12, 15, 18 and 24 after CAR T-cell infusion. Patients with PD at any time will complete a Progression visit. Patients that have completed the month 24 Follow-up visit or that they have progressed will be followed for survival and new anti-lymphoma therapy only. All patients will be followed for 2 years after the last patient randomised received the CAR T-cell infusion. ### Conditions Module **Conditions:** - Relapsed/Refractory Large B-cell Lymphoma **Keywords:** - Minimal Residual Disease - Large B-Cell Lymphoma - Anti-CD19 - CAR T - ctDNA - Lymphoma - DLBCL - HGBL - Epcoritamab - Lenalidomide - Rituximab ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** A phase II open-label, two-arm randomised non-comparative, multicentre study ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** EPCORITAMAB (EPCOR-ONLY) **Intervention Names:** - Drug: Epcoritamab **Label:** Arm A **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** EPCORITAMAB, LENALIDOMIDE AND RITUXIMAB (EPCOR-R2) **Intervention Names:** - Drug: Epcoritamab, lenalidomide and rituximab **Label:** Arm B **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Arm A **Description:** Epcoritamab will be administered as a 28-day cycle. In Cycle 1 and 2, epcoritamab will be given with step up dosing in Cycle 1. From Cycle 3 onwards dosing will be on Day 1 and 15 of each cycle. **Name:** Epcoritamab **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Arm B **Description:** Treatment with epcoritamab will be administered following the same dosing schedule as Arm A. On days where rituximab and/or lenalidomide are also due, epcoritamab should be administered last. Patients will receive lenalidomide once daily on Day 1-21 of each 28-day cycle, starting at Cycle 1 through to Cycle 6. Patients will receive rituximab administered by intravenous (IV) infusion on Day 1, 8, 15 and 22 of Cycle 1 and on Day 1 only of Cycles 2-6. **Name:** Epcoritamab, lenalidomide and rituximab **Type:** DRUG ### Outcomes Module #### Other Outcomes **Measure:** Correlation between tumour/immunological associations (using cytokine/chemokine profiles, clonal kinetics and phenotypic changes) and response (EFS and OS) **Time Frame:** From start of treatment till the end of study, assessed up to approximately 48 months **Measure:** Correlation between tumour/immunological associations (using cytokine/chemokine profiles, clonal kinetics and phenotypic changes) and treatment toxicity (number of participants with treatment-related AE) **Time Frame:** From start of treatment till the end of study, assessed up to approximately 48 months #### Primary Outcomes **Measure:** The efficacy of Epcor-only (epcoritamab alone) or Epcor-R2 (epcoritamab, lenalidomide and rituximab) consolidation as assessed by conventional (Lugano 2014) response criteria at month 12 after the CART infusion **Time Frame:** From start of treatment till the end of study, assessed up to approximately 12 months #### Secondary Outcomes **Measure:** To evaluate the safety of time-limited Epcor-only or Epcor-R2 consolidation post CAR T-cell therapy according to number of participants with treatment-related adverse events (AE) as assessed by CTCAE v5.0 **Time Frame:** From start of treatment till the end of study, assessed up to approximately 48 months **Measure:** The efficacy as assessed by molecular and conventional response criteria at defined time points with Event Free Survival (EFS) analyses **Time Frame:** From start of treatment till the end of study, assessed up to approximately 48 months **Measure:** The efficacy as assessed by molecular and conventional response criteria at defined time points with Overall Survival (OS) analyses **Time Frame:** From start of treatment till the end of study, assessed up to approximately 48 months **Measure:** The deliverability as assessed by rates of completion of the course of therapy **Time Frame:** From start of treatment till the end of study, assessed up to approximately 6 months **Measure:** The deliverability as assessed by protocol-defined number of dose-reductions of lenalidomide **Time Frame:** From start of treatment till the end of study, assessed up to approximately 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria 1. Age ≥ 18 years old at the time of signing the patient information and consent form (PICF) 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 3. A diagnosis of relapsed/refractory large B-cell lymphoma 4. Received Therapeutic Good Administration (TGA) approved anti-CD19 CAR T-cell therapy as the most recent large B-cell lymphoma treatment. 5. Partial metabolic response (PMR) or complete metabolic response (CMR) as per the Lugano criteria on a PET/CT performed 6. MRD positive by a ctDNA assay on a blood sample post CAR T-cell infusion 7. Adequate haematological function documented within 7 days prior to randomisation 8. Adequate cardiac function. 9. Adequate renal function, documented within 7 days prior to randomisation 10. Adequate hepatic function documented within 7 days prior to randomisation 11. Complete resolution of cytokine release syndrome (CRS), macrophage-activation syndrome (MAS)/haemophagocytic lymphohistiocytosis (HLH) or immune effector cell-associated neurotoxicity syndrome (ICANS) related to prior CAR T-cell therapy. 12. Female patients of childbearing potential (FCBP) must be willing to follow the contraceptive method/procedure as outline in the PICF 13. Sexually active males must agree to use a condom during sexual contact with a pregnant female or a FCBP for the course of the study through to 4 months after the last dose of epcoritamab, even if he has undergone a successful vasectomy 14. Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction. Men must also not donate sperm during the trial and for 4 months after receiving the last dose of epcoritamab 15. The patient understands the purpose of the trial and procedures required for the trial which includes compliance with the protocol requirements and restrictions listed in the PICF and in this protocol Exclusion Criteria 1. A history of Grade 4 CRS or ICANS related to prior CAR T-cell therapy 2. Patients whose lymphoma is known to be CD20 negative on the most recent biopsy prior to CAR T-cell therapy 3. Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment 4. Progression or relapse within 3 months after a regimen containing a bispecific antibody targeting CD3 and CD20 5. A diagnosis of primary central nervous system (CNS) lymphoma 6. Active secondary CNS involvement of lymphoma at time of screening 7. A known history or current autoimmune disease or other diseases resulting in permanent immunosuppression 8. Known cognitive impairment would place the patient at increased risk of complications from ICANS 9. A known history of hepatitis B serology consistent with acute or chronic infection 10. A known history of hepatitis C serology consistent with acute or chronic infection 11. A known history of testing positive for human immunodeficiency virus (HIV) 12. Any comorbidity conferring a life expectancy of \< 5 years (e.g., second malignancy) or that in the opinion of the site investigator may significantly impact the ability to complete the trial therapy and follow-up or affect the interpretation of results 13. Exposed to live or live attenuated vaccine within 4 weeks prior to signing the PICF. 14. Women who are pregnant or lactating 15. Known hypersensitivity to epcoritamab, lenalidomide, rituximab, tocilizumab or their excipients 16. Presence of any psychological, social or geographical or other condition for which participation would not be in the best interest of the patient **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Camperdown **Country:** Australia **Facility:** Royal Prince Alfred Hospital **State:** New South Wales **Zip:** 2050 **Location 2:** **City:** Westmead **Country:** Australia **Facility:** Westmead Hospital **State:** New South Wales **Zip:** 2145 **Location 3:** **City:** Herston **Country:** Australia **Facility:** Royal Brisbane and Women's Hospital **State:** Queensland **Zip:** 4029 **Location 4:** **City:** Melbourne **Country:** Australia **Facility:** Alfred Hospital **State:** Victoria **Zip:** 3000 **Location 5:** **City:** Melbourne **Country:** Australia **Facility:** Peter MacCallum Cancer Centre **State:** Victoria **Zip:** 3000 **Location 6:** **City:** Murdoch **Country:** Australia **Facility:** Fiona Stanley Hospital **State:** Western Australia **Zip:** 6150 #### Overall Officials **Official 1:** **Affiliation:** Peter MacCallum Cancer Centre, Australia **Name:** Michael Dickinson, MBBS, D Med Sc, FRACP, FRCPA **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000008206 - Term: Lymphatic Diseases - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases - ID: D000008228 - Term: Lymphoma, Non-Hodgkin ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11220 - Name: Lymphoma - Relevance: HIGH - As Found: Lymphoma - ID: M18828 - Name: Lymphoma, B-Cell - Relevance: HIGH - As Found: B-cell Lymphoma - ID: M20497 - Name: Neoplasm, Residual - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M11222 - Name: Lymphoma, Non-Hodgkin - Relevance: LOW - As Found: Unknown - ID: T3543 - Name: Lymphosarcoma - Relevance: HIGH - As Found: Lymphoma - ID: T640 - Name: B-cell Lymphoma - Relevance: HIGH - As Found: B-cell Lymphoma ### Condition Browse Module - Meshes - ID: D000008223 - Term: Lymphoma - ID: D000016393 - Term: Lymphoma, B-Cell ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018501 - Term: Antirheumatic Agents - ID: D000020533 - Term: Angiogenesis Inhibitors - ID: D000043924 - Term: Angiogenesis Modulating Agents - ID: D000006133 - Term: Growth Substances - ID: D000006131 - Term: Growth Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M373 - Name: Rituximab - Relevance: HIGH - As Found: Healthy - ID: M1725 - Name: Lenalidomide - Relevance: HIGH - As Found: Respiratory - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: M22318 - Name: Angiogenesis Inhibitors - Relevance: LOW - As Found: Unknown - ID: M9231 - Name: Growth Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000069283 - Term: Rituximab - ID: D000077269 - Term: Lenalidomide ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414135 **Brief Title:** Relmacabtagene Autoleucel for the Treatment of Systemic Sclerosis **Official Title:** A Dose Ranging Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of Relmacabtagene Autoleucel (Relma-cel) in Patients With Refractory/Progressive Systemic Sclerosis #### Organization Study ID Info **ID:** JWCAR029029 #### Organization **Class:** OTHER **Full Name:** RenJi Hospital ### Status Module #### Completion Date **Date:** 2027-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Shanghai Ming Ju Biotechnology Co., Ltd. #### Lead Sponsor **Class:** OTHER **Name:** Liangjing Lu #### Responsible Party **Investigator Affiliation:** RenJi Hospital **Investigator Full Name:** Liangjing Lu **Investigator Title:** Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Relma-cel is a product containing CD19-CAR-transduced T cells. The purpose of this study is to evaluate the safety of Relma-cel at different dose levels in patients with early diffuse systemic sclerosis. Efficacy will be explored too. If enrolled, participants will undergo leukapheresis, lymphodepleting chemotherapy and administration of Relma-cel. ### Conditions Module **Conditions:** - Systemic Sclerosis **Keywords:** - CAR-T cell therapy - systemic sclerosis - B cell depletion ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 6 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All participants will receive Relma-cel once at different dose levels **Intervention Names:** - Biological: Relma-cel **Label:** Relma-cel arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Relma-cel arm **Description:** All participants will receive Relma-cel once at different dose levels: 25×10\^6 CAR+ T cells、50×10\^6 CAR+ T cells、75×10\^6 CAR+ T cells **Name:** Relma-cel **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** the incidence of dose-limiting toxicity **Measure:** DLT rate **Time Frame:** 28 days **Description:** frequency and severity of AEs and SAEs **Measure:** Occurrence of AEs and SAEs **Time Frame:** 3 months #### Secondary Outcomes **Description:** Normally Relma-cel number and transgene copy number will gradually decrease to non-measurable as time goes on. **Measure:** Relma-cel cell numbers and transgene copy numbers and duration in blood **Time Frame:** baseline prior to Relma-cel administration, then through study completion, an average of 2 years after Relma-cel administration **Description:** Theoretically the number of CD19+ cells and other B cell subsets will significantly decreased following Relma-cel administration and gradually increase to normal level as the effect of Relma-cel disappear **Measure:** the changes of CD19+ cells and other B cell subsets **Time Frame:** baseline prior to Relma-cel administration, then through study completion, an average of 2 years after Relma-cel administration **Description:** Criss is an indicator to evaluate the efficacy of systemic sclerosis therapies. A score greater than or equal to 0.6 means Improvement. A score less than 0.6 means No Improvement. **Measure:** the change from baseline in Composite Response Index in Systemic Sclerosis (CRISS) **Time Frame:** baseline prior to Relma-cel administration, then through study completion, an average of 2 years after Relma-cel administration **Description:** SCTC-DI is a 23-item questionnaire to evaluate the organ damage in patients with systemic sclerosis. The range is between 0-55. The higher the score is, the worse the damage is. **Measure:** the change from baseline in Sclerodema Clinical Trial Consortium-Damage Index (SCTC-DI) **Time Frame:** baseline prior to Relma-cel administration, then through study completion, an average of 2 years after Relma-cel administration **Description:** mRSS is an instrument to evaluate cutaneous involvement in patients with systemic sclerosis. The total score ranges from 0 to 51. The higher the score is, the more the cutaneous involvement is. **Measure:** the change from baseline in modified Rodnan Skin Score (mRSS) **Time Frame:** baseline prior to Relma-cel administration, then through study completion, an average of 2 years after Relma-cel administration **Description:** The two items are used to evaluate pulmonary function. Normally both indicators should be greater than 80%. **Measure:** the change from baseline in pulmonary function (forced vital capacity (FVC) and diffusing capacity of the lungs for carbon monoxide (DLCO)) **Time Frame:** baseline prior to Relma-cel administration, then through study completion, an average of 2 years after Relma-cel administration **Description:** LVEF is an indicator of the heart's ability to eject blood out. The normal range is 50-55% **Measure:** the change from baseline in cardiac function (left ventricular ejection fraction, LVEF) **Time Frame:** baseline prior to Relma-cel administration, then through study completion, an average of 2 years after Relma-cel administration **Description:** HRCT is a radiology test of the lungs. In this trial, HRCT will be used to evaluate the lesion size of the lungs, e.g., a lesion could be 10% of the lungs. The greater the percentage is, the worse the lesion is. **Measure:** the change from baseline in high resolution computed tomography (HRCT) **Time Frame:** baseline prior to Relma-cel administration, then through study completion, an average of 2 years after Relma-cel administration **Description:** DAS-28 is a questionnaire to evaluate disease activity in patients with rheumatoid arthritis. 28 joints will be evaluated. Less than 2.6 means the disease is in remission. 2.6-3.2 means a low disease activity. More than 3.2 means active disease needing change in medication. More than 5.1 means very active disease that requires careful monitoring and adjustment to medication **Measure:** the change from baseline in disease activity score -28 (DAS-28) if any joint involvement **Time Frame:** baseline prior to Relma-cel administration, then through study completion, an average of 2 years after Relma-cel administration **Description:** CRP, ESR and ferritin are inflammation biomarkers. The normal ranges are different in different labs. Higher values than the upper limit of normal range mean the presence of inflammation. **Measure:** the change from baseline in the levels of inflammation biomarkers including C-reactive protein (CRP), erythropoietin sedimentation rate (ESR) and ferritin **Time Frame:** baseline prior to Relma-cel administration, then through study completion, an average of 2 years after Relma-cel administration **Description:** Normally all the antibodies are negative in human body. A positive result means abnormalities of immune system. **Measure:** systemic sclerosis specific antibodies, e.g., anti-scl-70 antibodies, anti-RNA polymerase III antibodies, anti-centrosome antibodies, antinuclear antibody (ANA) **Time Frame:** baseline prior to Relma-cel administration, then through study completion, an average of 2 years after Relma-cel administration **Description:** In the presence of systemic sclerosis, the increased number of T and B lymphocytes, the thinning of epiderm and the decreased number of sweat gland are expected. **Measure:** the change from baseline in skin biopsy pathology, e.g., the number of lymphocytes, the thickness of epiderm **Time Frame:** baseline prior to Relma-cel administration, then through study completion, an average of 2 years after Relma-cel administration **Description:** nailfold capillaroscopy is a device to observe the capillaries in the nailfold areas. With system sclerosis, the capillary density will diminish and expanded capillary loop may occur **Measure:** the change from baseline in nailfold capillaroscopy examination, e.g., the capillary density, the diameter of capillaries **Time Frame:** 12 months **Description:** the thickness of epiderm and dermis will be thinner in the presence of systemic sclerosis. **Measure:** the change from baseline in skin stiffness (measuring the thickness of epiderm and dermis) by skin ultrasound **Time Frame:** 12 months **Description:** HAQ-DI, assesses a patient's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in eight categories of functioning which represent a comprehensive set of functional activities - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. The stem of each item asks over the past week "Are you able to ..." perform a particular task. The patient's responses are made on a scale from zero (no disability) to three (completely disabled). The total score will be 0-3. The higher the score is, the worse the body function is. **Measure:** the change from baseline in health assessment questionnaire -damage index (HAQ-DI) **Time Frame:** 12 months **Description:** with Relma-cel administration, IgG, IgM, IgE, IgA will significantly decrease, then graduallly increase as the effect of Relma-cel disappears **Measure:** the change from baseline in IgG, IgM, IgE, IgA **Time Frame:** baseline prior to Relma-cel administration, then through study completion, an average of 2 years after Relma-cel administration ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * voluntary to sign the ICF * aged between 18-65 years old (inclusive) * diagnosed with diffuse systemic sclerosis according to 2013 ACR Systemic Sclerosis Classification Criterion * diagnosed with systemic sclerosis associated interstitial lung disease, defined as ground glass opacity on HRCT; and 55% ≤FVC\<70% or 55%≤DLCO \<70% * meet the definitions of refractory/progressive as below: 1. refractory: non-respondent to or disease recurrence after remission with conventional therapies. Conventional therapies are defined as treated for more than 6 months with low dose steroids (≤ 15 mg prednisone equivalent), cyclophosphamide, antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporin or biologics such as rituximab, belimumab, telitacicept, tocilizumab; 2. progressive: having below manifestations within 6 months 1. mRSS increases by \> 10% 2. FVC decreases by \> 10% or FVC decreases by \> 5% and DLCO decreases by \> 15% * without systemic active infections within 2 weeks of leukapheresis, e.g., infectious pneumonia, tuberculosis * available vascular access for leukapheresis * major organ functions: 1. Renal function: CrCl ≥50 ml/min (Cockcroft/Gault equation) 2. Bone marrow function: ANC ≥ 1000/uL, absolute lymphocyte count ≥100/uL, Hb ≥90 g/L, Platelet count ≥75 x 10\^9/L. Blood transfusion and infusion of growth factors within 7 days of eligibility assessment are not allowed. 3. Liver function: ALT ≤ 3 x ULN, AST ≤ 3 x ULN, total bilirubin ≤ 2 x ULN (in case of Gilbert syndrome, total bilirubin ≤ 3 x ULN) 4. Coagulation: INR ≤ 1.5 x ULN, PT ≤1.5 x ULN 5. Cardiac function: LVEF ≥ 55% * negative result of serum β-hCG measurement for women of childbearing potential at screening and within 48 hours of the first dose of lymphodepletion * Female subjects with childbearing potential or male subjects with partners of childbearing potential should adopt medically effective contraception or abstinence from enrollment to 2 years after the end of the study; female subjects with childbearing potential should have a negative serum hCG test within 7 days of enrollment and not in lactation Exclusion Criteria: * NYHA class IV * FVC predicted \< 45% or DLCO predicted \< 40% * abnormalities on HRCT not attributable to systemic sclerosis * history of autologous stem cell transplantation * with manifestations of renal crisis * with other autoimmune comorbidities that need systemic treatment * with a history of severe drug allergy * with congenital immunoglobulin deficiency * with malignant tumors, except for nonmelanoma skin cancer, in situ cervical cancer, bladder cancer, breast cancer which has been disease free for more than 2 years * with psychiatric diseases or severe cognition dysfunctions * within 5 half-life cycles of the last administration of an investigational product * pregnant, lactation or plan to be pregnant within one year * a history of CAR-T therapy or other gene-modified T cell targeted therapies * other conditions that are not suitable for enrollment of the study in the judgement of the investigator * the use of any live vaccines against infections within one month of the screening * with any manifestations of active tuberculosis at screening **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Lu_liangjing@163.com **Name:** Liangjing Lu **Phone:** 86-13661472001 **Role:** CONTACT **Contact 2:** **Email:** Relma-celMedical@jwtherapeutics.com **Name:** medical JW **Phone:** +86 21 50464201 **Role:** CONTACT #### Locations **Location 1:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Email:** Lu_liangjing@163.com - **Name:** Liangjing Lu - **Phone:** 86-13661472001 - **Role:** CONTACT **Country:** China **Facility:** Renji Hospital, Shanghai Jiaotong University School of Medicine **Zip:** 200001 #### Overall Officials **Official 1:** **Affiliation:** RenJi Hospital **Name:** Liangjing Lu **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15415 - Name: Sclerosis - Relevance: HIGH - As Found: Sclerosis - ID: M15412 - Name: Scleroderma, Systemic - Relevance: HIGH - As Found: Systemic Sclerosis - ID: M25560 - Name: Scleroderma, Diffuse - Relevance: HIGH - As Found: Systemic Sclerosis - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: T5565 - Name: Systemic Scleroderma - Relevance: HIGH - As Found: Systemic Sclerosis - ID: T1861 - Name: Diffuse Cutaneous Systemic Sclerosis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012595 - Term: Scleroderma, Systemic - ID: D000045743 - Term: Scleroderma, Diffuse - ID: D000012598 - Term: Sclerosis ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414122 **Acronym:** MOMENT **Brief Title:** Modulated Mid-frequency Whole-body Electromyostimulation and Nutritional Therapy in Gastrointestinal Cancer Patients **Official Title:** The Efficacy of Modulated Mid-frequency (Whole-body Electromyostimulation) and Nutritional Therapy in Patients With Solid Tumors of the Gastrointestinal Tract (Excluding Liver and Pancreatic Carcinomas) #### Organization Study ID Info **ID:** 22-1294 #### Organization **Class:** OTHER **Full Name:** University of Cologne ### Status Module #### Completion Date **Date:** 2026-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Cologne #### Responsible Party **Investigator Affiliation:** University of Cologne **Investigator Full Name:** Helen Schörghofer **Investigator Title:** Helen Schörghofer **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The purpose of this study is to assess the efficacy of modulated mid-frequency whole-body electromyostimulation (WB-EMS) combined with nutritional therapy in patients with gastrointestinal cancer. **Detailed Description:** This study aims to combine the applicability and effectiveness of a form of strength training with targeted nutritional training. For this purpose, training with electromyostimulation (application of modulated mid-frequency; WB-EMS) is carried out, which pursues the effect of cell activation and the improvement of muscle strength. The primary aim of the multimodal intervention presented here is to increase muscle mass and improve energy utilisation and metabolism. Patients should experience increased mobility and independence as a result of this intervention. In the study, patients are randomly assigned to one of two groups, with one group receiving an application of electricity and the other group performing standardised exercise therapy without electricity. Otherwise, the groups do not differ in the applications or tests. In addition, nutritional coaching takes place in both groups with digital nutritional coaching. Patients with a malignant tumour of the oesophagus, stomach, duodenum or colon or rectum with medical therapy administered before or after surgery (neoadjuvant and adjuvant therapy) and after surgery without further therapy can participate in the study. The aim is to compare the use of electromyostimulation in this multimodal approach regarding its effectiveness in terms of muscle growth compared to the conventional multimodal approach. The research hypothesis is that the additional training stimulus provided by the application of electricity leads to significantly higher muscle growth than conventional training without electricity. ### Conditions Module **Conditions:** - Oesophageal Cancer - Gastric Cancer - Duodenal Cancer - Colorectal Cancer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 88 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Intervention group receives multimodal therapy with whole-body electromyostimulation and exercise therapy (WB-EMS) as well as conventional nutritional counseling with guidelines and digital nutritional coaching **Intervention Names:** - Other: mid-frequency whole-body electromyostimulation (WB-EMS) - Other: nutritional therapy **Label:** WB-EMS **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Control group receives multimodal therapy with moderate conventional exercise training in a group and conventional nutritional counselling with guidelines and digital nutritional coaching **Intervention Names:** - Other: conventional exercise training - Other: nutritional therapy **Label:** CONTROL **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - WB-EMS **Description:** supervised group training sessions at least once and optionally twice a week, lasting 11-20 minutes, over 12 weeks, 12-24 training sessions in total **Name:** mid-frequency whole-body electromyostimulation (WB-EMS) **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - CONTROL **Description:** supervised group training at least once a week, optional additional home-based training once a week, lasting 40 minutes, over 12 weeks, 12-24 training sessions in total **Name:** conventional exercise training **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - CONTROL - WB-EMS **Description:** conventional nutritional counselling with guidelines and digital nutritional coaching **Name:** nutritional therapy **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Muscle mass of the quadriceps muscle (vastus lateralis / rectus femoris), cross-sectional diameter (CSD) using ultrasound. Muscle ultrasound represents a cheap and user-friendly, yet robust and reliable, method to monitor muscle mass. **Measure:** Muscle mass of the quadriceps muscle **Time Frame:** Baseline and week 12 #### Secondary Outcomes **Description:** Body composition including skeletal muscle mass, fat free mass, fat mass, total body water, body cell mass and extracellular mass, using bioimpedance analysis (BIA) (Nutriguard-MS) **Measure:** Body composition **Time Frame:** Baseline and week 12 **Description:** Performance Status, with the help of Karnofsky Index (range 0 - 100, higher = better) **Measure:** Performance Status **Time Frame:** Baseline and week 12 **Description:** Endurance capacity, using spiroergometry measuring maximal oxygen uptake (VO2 max) (higher = better) **Measure:** Endurance capacity **Time Frame:** Baseline and week 12 **Description:** Lower limb performance, using 1 minute sit-to-stand test (higher = better) **Measure:** Lower limb performance **Time Frame:** Baseline and week 12 **Description:** Upper limb performance, using hand grip strength dynamometry (higher = better) **Measure:** Upper limb performance **Time Frame:** Baseline and week 12 **Description:** Fatigue symptoms, using the 13-item Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT Fatigue Scale). The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact on daily activities and function. Score range 0-52 (higher = better) **Measure:** Fatigue **Time Frame:** Baseline and week 12 **Description:** Quality of life, using the EORTC QLG Core Questionnaire (EORTC QLQ-C30). The EORTC QLQ-C30 is a 30-item instrument meant to assess some of the different aspects that define the quality of life of cancer patients. Score range 0-100 (higher = better) **Measure:** health-related Quality of life **Time Frame:** Baseline and week 12 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with oesophageal, gastric, duodenal, colon or rectal cancer following surgery without further therapy and with neoadjuvant and adjuvant therapy * medical clearance for exercise training * written declaration of consent from the study participant Exclusion Criteria: * Participation in another study on the topic of exercise or nutrition * Electronic implants such as pacemakers, pumps, and coronary stents * Cardiac arrhythmia * Implants in the area of application (e.g. breast implants) * Pregnancy * Epilepsy * Wounds and open skin diseases in the area of application of the electrodes * Unhealed operations or bone fractures * Acute inflammatory diseases (e.g. inflammation of the intervertebral discs, bones, vessels, or soft tissue) * Directly after herniated discs or other instabilities such as large abdominal wall hernias * Blood clots (thromboses) * Bone diseases with high-grade osteoporosis * Increased risk of haemorrhage * Fever and illnesses that can be aggravated by physical exertion * Untreated high blood pressure * Blindness * Continuous parenteral nutrition * Metal and electronic parts in the body (e.g. prostheses, metal vascular clips, hearing aids/inner ear/cochlear implants, magnetic dental prostheses, pacemakers, contraceptives) **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** helen.schoerghofer@uk-koeln.de **Name:** Helen Schörghofer **Phone:** +49221478 **Phone Ext:** 42646 **Role:** CONTACT #### Locations **Location 1:** **City:** Cologne **Contacts:** ***Contact 1:*** - **Email:** helen.schoerghofer@uk-koeln.de - **Name:** Helen Schörghofer - **Phone:** +49221478 - **Phone Ext:** 42646 - **Role:** CONTACT **Country:** Germany **Facility:** Universitätsklinikum Köln, Centrum für Integrierte Onkologie (CIO) **State:** NRW **Zip:** 50937 #### Overall Officials **Official 1:** **Affiliation:** Universitätsklinikum Köln **Name:** Freerk T Baumann, Univ.-Prof. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** IPD will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to helen.schoerghofer@uk-koeln.de. To gain access, data requestors will need to sign a data access agreement. **Description:** All IPD that underlie results in a publication **IPD Sharing:** YES **Time Frame:** Beginning 6 months and ending 24 months after article publication ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007414 - Term: Intestinal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000004378 - Term: Duodenal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16064 - Name: Stomach Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M13110 - Name: Pancreatic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7553 - Name: Duodenal Neoplasms - Relevance: HIGH - As Found: Duodenal Cancer - ID: M10448 - Name: Intestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7552 - Name: Duodenal Diseases - Relevance: LOW - As Found: Unknown - ID: T5486 - Name: Stomach Cancer - Relevance: LOW - As Found: Unknown - ID: T2141 - Name: Esophageal Cancer - Relevance: HIGH - As Found: Oesophageal Cancer - ID: T4387 - Name: Pancreatic Cancer - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004379 - Term: Duodenal Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: Hemat - Name: Hematinics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414109 **Brief Title:** Mindfulness-Based Intervention for Adolescents With Chronic Migraine **Official Title:** Mindfulness-Based Intervention for Adolescents With Chronic Migraine #### Organization Study ID Info **ID:** 22-2359 #### Organization **Class:** OTHER **Full Name:** University of Colorado, Denver ### Status Module #### Completion Date **Date:** 2025-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Children's Hospital Colorado #### Lead Sponsor **Class:** OTHER **Name:** University of Colorado, Denver #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this study is to assess feasibility and acceptability of a mindfulness-based intervention adapted for adolescents with migraine to inform a future randomized trial assessing effects of the intervention on headache-related outcomes. **Detailed Description:** Mindfulness-based intervention (MBI) shows promise in adults with migraine, but research is limited in adolescents. The current study aims to advance behavioral treatments for adolescents with frequent migraine by adapting an existing empirically-supported MBI for adolescents (Learning to BREATHE) to meet the unique needs of adolescents with chronic migraine. In Phase I of the study, we will use feedback solicited from interviews with teens with chronic migraine, their parents, and healthcare providers documenting the experience of living with chronic migraine and on the content and delivery of the MBI to create an adapted telehealth group intervention specifically tailored for adolescents with frequent migraine. In Phase II of the study, the adapted MBI will be piloted in a single-arm trial with adolescents with frequent migraine to assess feasibility, acceptability, and preliminary clinical signals. ### Conditions Module **Conditions:** - Migraine - Migraine in Adolescence **Keywords:** - Adolescent - Mindfulness - Mindfulness Intervention - Migraine - Headache ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 25 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive 6 weekly 1-hour sessions of a remotely-delivered mindfulness-based intervention in a group setting. **Intervention Names:** - Behavioral: BREATHE-Migraine **Label:** BREATHE-Migraine **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - BREATHE-Migraine **Description:** The BREATHE-Migraine intervention was adapted from the research-supported curriculum, "Learning to BREATHE" (Broderick, 2021), based on qualitative feedback from adolescents with migraine, their parents, and pediatric headache providers. BREATHE-Migraine includes experiential and didactic exercises designed to address emotion regulation and the stress of living with frequent migraine. **Name:** BREATHE-Migraine **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Percent of sessions attended; Qualitative data generated via focus group interviews (questions will include barriers and facilitators to completing the intervention) **Measure:** Intervention feasibility **Time Frame:** Up to 6 weeks **Description:** Ratings on program acceptability questionnaire (higher scores indicate higher acceptability); Qualitative data generated via focus group interviews (questions will include positive and negative perceptions of the intervention) **Measure:** Intervention acceptability **Time Frame:** 7 weeks #### Secondary Outcomes **Description:** The Pediatric Migraine Disability Assessment (PedMIDAS) is a 6-item self-report questionnaire measuring the extent to which headaches interfered with school attendance and functioning, home functioning, and social attendance and functioning. Adolescents will be asked to indicate the number of days in the past 3 months in which they were unable to attend or fully participate in a range of activities. Lower scores indicate less disability. **Measure:** Change in headache-related disability **Time Frame:** Baseline, 6 weeks **Description:** The Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) is an 18-item self-report measure of various dimensions of emotion dysregulation. Items are rated on a 6-point Likert scale ranging from 1 (almost never) to 5 (almost always). The DERS-SF provides a total score and 6 subscale scores. Lower scores indicate better emotion regulation. **Measure:** Change in emotion regulation **Time Frame:** Baseline, 6 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 13 to 18 years * Diagnosed with migraine by medical provider using criteria from the International Classification of Headache Disorders, Third Edition * Patient report of \>= 8 headache days per month * PedMIDAS Score of \> 10 (at least mild headache-related disability) Exclusion Criteria: * Weekly or bi-weekly therapy with a licensed behavioral health provider * Major comorbid medical condition (e.g., cancer, epilepsy) * Active psychosis or suicidal ideation * Inability to provide consent/assent **Maximum Age:** 18 Years **Minimum Age:** 13 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** michelle.clementi@childrenscolorado.org **Name:** Michelle A Clementi, PhD **Phone:** 720-777-7487 **Role:** CONTACT **Contact 2:** **Email:** michelle.harmon@childrenscolorado.org **Name:** Michelle Harmon, BS **Phone:** 720-777-4904 **Role:** CONTACT #### Locations **Location 1:** **City:** Aurora **Contacts:** ***Contact 1:*** - **Email:** michelle.clementi@childrenscolorado.org - **Name:** Michelle A Clementi, PhD - **Phone:** 720-777-7487 - **Role:** CONTACT ***Contact 2:*** - **Email:** michelle.harmon@childrenscolorado.org - **Name:** Michelle Harmon, BS - **Phone:** 720-777-4904 - **Role:** CONTACT **Country:** United States **Facility:** Children's Hospital Colorado **State:** Colorado **Zip:** 80045 #### Overall Officials **Official 1:** **Affiliation:** University of Colorado, Denver **Name:** Michelle A Clementi, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000051270 - Term: Headache Disorders, Primary - ID: D000020773 - Term: Headache Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### 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: M9351 - Name: Headache - Relevance: LOW - As Found: Unknown - ID: M11852 - Name: Migraine Disorders - Relevance: HIGH - As Found: Migraine - ID: M22529 - Name: Headache Disorders - Relevance: LOW - As Found: Unknown - ID: M26657 - Name: Headache Disorders, Primary - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008881 - Term: Migraine Disorders ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414096 **Brief Title:** Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome **Official Title:** Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome #### Organization Study ID Info **ID:** 23-1702 #### Organization **Class:** OTHER **Full Name:** University of Colorado, Denver ### Status Module #### Completion Date **Date:** 2026-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Colorado, Denver #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** Hypothesis: The investigators hypothesize that pulsatile FSH intravenous administration to women with obesity will correct the Reprometabolic Syndrome (RMS) luteal deficiency phenotype. Specific Aim: To test the hypothesis that pulsatile IV administration of FSH will rescue the impaired folliculogenesis and relative hypogonadotropic hypogonadism, characteristic of obesity. The investigators will accomplish this by administering a cycle of pulsatile FSH to women with obesity and comparing their hormone output to a cycle using conventional, daily FSH injection at the identical daily dose. The primary outcome will be luteal phase progesterone excretion. **Detailed Description:** Design: Crossover interventional study. The investigators have selected this design to allow us to compare each woman to herself in consecutive cycles whenever possible. Methods: Patient population and protocol: The investigators plan to recruit women with obesity for a proof-of-concept study to demonstrate the potential of this treatment to improve fertility. Before such a treatment would be brought into clinical practice, a more comprehensive program of pre-conceptional care would be desirable to improve the metabolic health of women with obesity and minimize pregnancy complications such as preterm birth and pregnancy related hypertension. However, that is not the goal of this preliminary study which only seeks to identify reproductive hormone impact. Consent/Screening Process: A script for screening participants by telephone who inquire in response to advertisements will be used, which will include the required verbal consent language. Participants who are eligible for enrollment will be asked to come to the Clinical and Translational Research Center (CTRC) for an intake examination and qualifying laboratory tests. At this time, informed consent is obtained by the PI, the Professional Research Assistant, or an Institutional review Board (IRB) approved designee, according to the scripted process. The informed consent discussion is always held in a private room that is free of distractions and participants are allowed the opportunity to ask questions and have their questions answered to their satisfaction before signing the informed consent document. Once informed consent has been provided, procedures are performed as outlined in the procedures section. The investigators will prepare the participants for either a cycle of pulsatile FSH or conventional, daily FSH injection at the identical daily dose of FSH for both conditions. Participants will be randomized to group A, pulsatile FSH and then conventional daily injected FSH, or group B, conventional FSH and then pulsatile FSH, by the study statistician. Participants will not be blinded to treatment. However, the PI and co-investigator, as well as the research assistant who will perform the assays, will not be expected to be involved in direct care of participants during treatment and will therefore be able to remain blinded to treatment assignment. To control hormone delivery for both conditions (non-pulsatile FSH vs pulsatile FSH), all participants will receive a Gonadotropin Releasing Hormone (GnRH) antagonist during gonadotropin stimulation and up to the day of Human Chorionic Gonadotropin (HCG) trigger to abolish endogenous gonadotropin production. A baseline ultrasound will be performed within 2 days of the onset of menses to assure that no dominant follicles are present on ovarian ultrasound and E2 is \<50 pg/ml prior to initiating stimulation, as per usual clinical practice. The remaining protocol will be administered in the second cycle, after a 1-month 'washout' period to avoid the possibility of carryover. ### Conditions Module **Conditions:** - Infertility - Obesity ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** Examine effects of pulsatile FSH administration as a new method for stimulation in IVF ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 5 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A daily gonadotropin dose (typically 75-450 IU) will be assigned and adjusted, based on clinical criteria and, if known, past response to hormones. Recombinant human FSH (rhFSH) will be given as a daily subcutaneous injection, as is performed, by patients at home, in routine clinical practice. **Intervention Names:** - Drug: Follicle Stimulating Hormone **Label:** Conventional Subcutaneous FSH Dosing **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** participants will receive the same daily rhFSH dose (based on clinical practice criteria); however, it will be delivered via a portable infusion pump with reservoir (Avocet Infusion Pump, Eitan Medical LTD) that will provide an IV bolus (100-500 µl) every 90 minutes, a frequency that has previously been shown to result in physiologic ovulatory cycles in GnRH deficient women (Martin). The total gonadotropin dose delivered over a 24 hour period will be typically 75-450 IU, assigned based on standard of care clinical criteria (max dose is 900IU per clinical care guidelines). Participants will be provided with a 100mL preloaded reservoir, calibrated to deliver the approved standard of care dosing, in 16 boluses (100-500µl) over 24 hours (q 90min), for 7-12 days. Each 100 ml reservoir has capacity for 200 doses if the volume is 500 µl, which is sufficient for the typical 7- 12-day protocol. **Intervention Names:** - Drug: Follicle Stimulating Hormone **Label:** Pulsatile IV FSH Dosing **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Conventional Subcutaneous FSH Dosing - Pulsatile IV FSH Dosing **Description:** Pulsatile FSH administration via a portable pump. **Name:** Follicle Stimulating Hormone **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The primary endpoint of the study is luteal progesterone metabolite (pregnanediol; Pdg) excretion. Luteal Pdg will be compared in the pulsatile FSH cycle to the daily dose subcutaneous (SQ) cycle. Patients who conceive in the cycle of study will not have their conception cycle included in the analysis. **Measure:** Urinary Pdg concentration **Time Frame:** 4 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * • BMI between 30 kg/m2 and 40 kg/m * Weight stability, i.e. no continued weight loss of \>1lb per week for a minimum of 4 weeks prior to enrollment * Normal thyroid stimulating hormone (TSH) and prolactin * Anti-Mullerian Hormone (AMH) \> 1 ng/ml or \< 8 ng/mL * Willingness to postpone conception for the first study cycle * Involuntary inability to conceive for at least 6 months * No clinical diagnosis of polycystic ovarian syndrome (PCOS) * Documentation of ovulation with luteal progesterone \>6 ng/ml or positive ovulation predictor home testing * Regular menstrual cycles 25-40 days in length * Male partner (or sperm donor) with adequate sperm (\>14 million sperm per ml) * Hysterosalpingogram or saline infusion sonography demonstrating at least one patent Fallopian tube and a normal uterine cavity * Serum total and free testosterone within the 95% CIearance for women with obesity previously studied in our laboratory. * Acceptance of the indwelling catheter and willingness to take part in the study Exclusion Criteria: - **Gender Based:** True **Gender Description:** Females are only being recruited because this study looks at ovarian response **Healthy Volunteers:** True **Maximum Age:** 37 Years **Minimum Age:** 19 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Katherine.Kuhn@cuanschutz.edu **Name:** Katherine Kuhn, MS **Phone:** 303-7245276 **Role:** CONTACT **Contact 2:** **Email:** Asma.Gioranzi@ucdenver.edu **Name:** Asma Giornazi, MS **Phone:** 303-724-5276 **Role:** CONTACT #### Locations **Location 1:** **City:** Aurora **Contacts:** ***Contact 1:*** - **Email:** Katherine.Kuhn@cuanschutz.edu - **Name:** Katherine Kuhn, MS - **Phone:** 303-724-5276 - **Role:** CONTACT ***Contact 2:*** - **Name:** Nanette Santoro, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of COlorado Anschutz Medical Campus **State:** Colorado **Zip:** 80045 #### Overall Officials **Official 1:** **Affiliation:** University of Colorado School of Medicine **Name:** Nanette Santoro, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### See Also Links **Label:** Pulsatile gonadotropin administration in in-vitro fertilisation **URL:** https://pubmed.ncbi.nlm.nih.gov/6144950/ **Label:** . Estradiol Priming Improves Gonadotrope Sensitivity and Pro-Inflammatory Cytokines in Obes **URL:** https://pubmed.ncbi.nlm.nih.gov/26425884/ **Label:** Acute recapitulation of the hyperinsulinemia and hyperlipidemia characteristic of metabolic syndrome suppresses gonadotropins. **URL:** https://pubmed.ncbi.nlm.nih.gov/28158916/ **Label:** Closed intravenous administration of gonadotropin-releasing hormone: safety of extended peripheral intravenous catheterization **URL:** https://pubmed.ncbi.nlm.nih.gov/2664612/ **Label:** Effects of pulsatile intravenous follicle- stimulating hormone treatment on ovarian function in women with obesity. **URL:** https://pubmed.ncbi.nlm.nih.gov/37276947/ **Label:** Pulsatile luteinizing hormone amplitude and progesterone metabolite excretion are reduced in obese women. **URL:** https://pubmed.ncbi.nlm.nih.gov/17440019/ **Label:** Gonadotropin response to insulin and lipid infusion reproduces the reprometabolic syndrome of obesity in eumenorrheic lean women: a randomized crossover trial. **URL:** https://pubmed.ncbi.nlm.nih.gov/33838870/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M10290 - Name: Infertility - Relevance: HIGH - As Found: Infertility - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007246 - Term: Infertility ### Intervention Browse Module - Ancestors - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M9789 - Name: Hormones - Relevance: HIGH - As Found: Loss - ID: M8759 - Name: Follicle Stimulating Hormone - Relevance: HIGH - As Found: Conjunctival - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000006728 - Term: Hormones - ID: D000005640 - Term: Follicle Stimulating Hormone ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414083 **Brief Title:** Histologic Comparison of Ablative Techniques for Endometriosis **Official Title:** Histologic Comparison of Ablative Techniques for Endometriosis - a Randomized Trial #### Organization Study ID Info **ID:** 24-007 #### Organization **Class:** OTHER **Full Name:** TriHealth Inc. ### Status Module #### Completion Date **Date:** 2025-06-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-09 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** TriHealth Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** To our knowledge, no other human studies directly compare the effectiveness of the various ablative technologies. We set out to design a study to directly compare ablative energy sources and evaluate their ability to destroy native endometriosis tissue in humans. ### Conditions Module **Conditions:** - Endometriosis - Endometriosis-related Pain - Endometriosis Pelvic - Endometriosis; Peritoneum ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Masking Description:** Pathologist is blinded to treatment arm **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 141 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Device: Diathermy **Label:** Diathermy **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Device: CO2 Laser **Label:** CO2 Laser **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Intervention Names:** - Device: Argon Beam Coagulator **Label:** Argon Beam Coagulator **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Diathermy **Description:** Diathermy will be used to ablate the randomized sample. **Name:** Diathermy **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - CO2 Laser **Description:** CO2 Laser will be used to ablate the randomized sample. **Name:** CO2 Laser **Type:** DEVICE #### Intervention 3 **Arm Group Labels:** - Argon Beam Coagulator **Description:** Argon Beam Coagulator will be used to ablate the randomized sample. **Name:** Argon Beam Coagulator **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Endometriosis seen on pathologic sample. **Measure:** Positive Histology **Time Frame:** 0 days #### Secondary Outcomes **Description:** Pre-operative and Post-operative Pelvic Pain Visual Analog Scale. Minimum Score 0. Maximum Score 100. Higher score is worse outcome. **Measure:** Pelvic Pain **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult women 18 years of age or older * Already planning to undergo scheduled robotic assisted or laparoscopic excision of lesions for pelvic pain symptoms (pelvic pain, dysmenorrhea, dyspareunia, dysuria, dyschezia, ovarian pain) or endometriosis of any kind (endometriosis of any location, or endometrioma) Exclusion Criteria: * Known pregnancy at enrollment or at the time of the excision surgery **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** devin_namaky@trihealth.com **Name:** Devin Namaky, MD **Phone:** 513-862-1888 **Role:** CONTACT #### Locations **Location 1:** **City:** Cincinnati **Contacts:** ***Contact 1:*** - **Email:** devin_namaky@trihealth.com - **Name:** Devin Namaky, MD - **Phone:** 513-862-1888 - **Role:** CONTACT **Country:** United States **Facility:** Good Samaritan Hospital **State:** Ohio **Status:** RECRUITING **Zip:** 45220 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000091662 - Term: Genital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions ### Condition Browse Module - Browse Leaves - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M7877 - Name: Endometriosis - Relevance: HIGH - As Found: Endometriosis - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004715 - Term: Endometriosis ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414070 **Brief Title:** Developing and Testing the Jenga Dada Intervention in Kenya **Official Title:** Jenga Dada: A Group-based Intervention to Prevent Partner Violence and Unintended Pregnancy Among Women in Kenya #### Organization Study ID Info **ID:** 800987 #### Organization **Class:** OTHER **Full Name:** University of California, San Diego ### Status Module #### Completion Date **Date:** 2024-11-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-11-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Population Council Kenya **Class:** UNKNOWN **Name:** Women's Empowerment Link **Class:** OTHER **Name:** San Diego State University #### Lead Sponsor **Class:** OTHER **Name:** University of California, San Diego #### Responsible Party **Investigator Affiliation:** University of California, San Diego **Investigator Full Name:** Jay G. Silverman, PhD **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 study aims to work with women's economic empowerment groups within the community to address reproductive coercion and intimate partner violence and promote economic self-sufficiency among women (aged 15+ years). Based on our previous research in the United States, Bangladesh, and Kenya, the ARCHES (Addressing Reproductive Coercion in Health Settings) intervention is a highly effective clinic-based model to improve women's ability to use family planning and cope with abuse. Due to common requests for community-based support, we are adapting content from the ARCHES intervention along with Girls Invest, an economic empowerment intervention implemented in the US and Nigeria, to develop Jenga Dada, which means "Build a Woman Up" in Kiswahili, to be delivered to women's economic empowerment groups. The study will conduct formative research among women's economic empowerment group members, develop the Jenga Dada intervention, and conduct a pilot cluster randomized controlled trial to assess preliminary efficacy of the intervention on proximal outcomes (i.e., self-efficacy) and feasibility and acceptability. **Detailed Description:** Background: This project aims to develop and preliminarily evaluate an intervention, Jenga Dada, on its feasibility, acceptability, and efficacy to increase women's and girl's ability to successfully cope with reproductive coercion (RC), intimate partner violence (IPV), economic abuse, and promote reproductive health and economic self-sufficiency among women participating in economic empowerment groups in rural and peri-urban areas of Uasin Gishu county, Kenya. Jenga Dada is being developed as an innovative hybrid approach based on adaptation and integration of core content from two effective interventions: ARCHES (Addressing Reproductive Coercion in Health Settings) and Girls Invest. ARCHES is a clinic-based contraceptive counseling intervention designed and demonstrated to support voluntary contraceptive use and reduce physical IPV. ARCHES was originally designed in the U.S. and has been adapted to and evaluated, with positive results, in Bangladesh and Nairobi, Kenya, and is currently being adapted for scale-up in public sector facilities in Uasin Gishu county, Kenya. Girls Invest is a mobile health application (mHealth app) with integrated intervention modules on gender, IPV, and financial literacy demonstrated to be feasible and acceptable among adolescent girls in the U.S. and Nigeria (efficacy evaluation ongoing). Jenga Dada combines the information and education from ARCHES and Girls Invest in a group discussion-based curriculum, delivered by a local women's empowerment non-governmental organization (NGO), that aims to build social support for women, delivered within women's economic empowerment groups as they move towards economic self-sufficiency, reproductive autonomy, and violence-free relationships. Intervention: Jenga Dada educational sessions will be delivered to existing women's economic empowerment group participants during regular meetings by a facilitator from a local NGO. Sessions will include education and facilitated group discussions on gender, RC, IPV, economic abuse, and financial literacy to bolster understanding, shift attitudes and norms, and support peers on these issues. One 60-minute guided group discussion will take place for each of the eight training modules during the weekly or bi-weekly women's economic empowerment group meetings. Methodology: In this pilot trial, we will test the hypothesis that women participating in Jenga Dada will report improved proximal outcomes regarding a) financial self-efficacy, b) coping with economic abuse, IPV, and RC (self-efficacy to seek assistance for IPV and coping strategies to maintain contraceptive use in the face of opposition), c) reproductive health (self-efficacy to use contraceptives, including in the face of RC), and d) self-efficacy to seek support from women's economic group members and to support other members experiencing violence. Study activities include formative research to inform development of Jenga Dada based on the lived experience of women and girls and implementers in this context, pilot testing, and evaluation of the effects of Jenga Dada on IPV, reproductive health, and economic outcomes. The evaluation will occur in two phases via random assignment of 18 existing women's economic empowerment groups to receive either Jenga Dada or standard women's economic empowerment group programming with baseline and 4-month follow-up survey data collected (n=280 participants, ages 15+ years). We will also collect and analyze process data and post-program qualitative data among participants and implementers to evaluate the feasibility and acceptability of the program. ### Conditions Module **Conditions:** - Reproductive Coercion - Intimate Partner Violence - Economic Abuse **Keywords:** - Reproductive coercion - Intimate partner violence - Contraceptive Usage - Economic Abuse ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Cluster-randomized controlled trial; stratified randomization based on urban/rural location ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 280 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Jenga Dada programming in women's economic empowerment group meetings **Intervention Names:** - Behavioral: Jenga Dada **Label:** Intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Standard women's economic empowerment group programming **Label:** Waitlist Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention **Description:** Jenga Dada aims to empower women participating in community-based economic groups by training them to recognize inequality, challenge it, and work toward positive changes in their lives related to finances, health, and relationships and increase social support on these issues within the groups. Jenga Dada is expected to include eight modules: 1) overview of the intervention, 2) gender roles, 3) economic control and abuse, 4) intimate partner violence (IPV), 5) reproductive coercion (RC), 6) family planning (FP), 7) financial literacy, and 8) life goals. The Jenga Dada intervention is group discussion-based and draws on two effective interventions: ARCHES (a facility-based contraceptive counseling intervention providing support for RC and IPV) and Girls Invest (a mobile health application with integrated modules on gender, IPV, and financial literacy). The intervention will be facilitated by a local NGO in partnership with group leaders. **Name:** Jenga Dada **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Change in mean self-efficacy score (range: 4-12, higher=higher self-efficacy) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences) **Measure:** Financial self-efficacy **Time Frame:** Baseline and 4-month follow-up **Description:** Change in mean self-efficacy score (range: 6-18, higher=higher self-efficacy) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences) **Measure:** Self-efficacy to cope with economic abuse **Time Frame:** Baseline and 4-month follow-up **Description:** Change in mean self-efficacy score (range: 11-33, higher=higher self-efficacy) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences) **Measure:** Self-efficacy to use family planning among women of reproductive age (15-49 years) **Time Frame:** Baseline and 4-month follow-up **Description:** Change in mean self-efficacy score (range: 3-9, higher=higher self-efficacy) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences) **Measure:** Self-efficacy to use family planning in the face of reproductive coercion among women of reproductive age (15-49 years) **Time Frame:** Baseline and 4-month follow-up **Description:** Change in mean self-efficacy score (range: 1-3, higher=higher self-efficacy) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences) **Measure:** Self-efficacy to seek support from the group/group members for economic abuse **Time Frame:** Baseline and 4-month follow-up **Description:** Change in mean self-efficacy score (range: 1-3, higher=higher self-efficacy) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences) **Measure:** Self-efficacy to seek support from the group/group members for reproductive coercion among women of reproductive age (15-49 years) **Time Frame:** Baseline and 4-month follow-up **Description:** Change in mean self-efficacy score (range: 1-3, higher=higher self-efficacy) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences) **Measure:** Self-efficacy to seek support from the group/group members for intimate partner violence **Time Frame:** Baseline and 4-month follow-up **Description:** Change in mean self-efficacy score (range: 2-6, higher=higher self-efficacy) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences) **Measure:** Self-efficacy to support someone experiencing economic abuse **Time Frame:** Baseline and 4-month follow-up **Description:** Change in mean self-efficacy score (range: 2-6, higher=higher self-efficacy) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences) **Measure:** Self-efficacy to support someone experiencing reproductive coercion **Time Frame:** Baseline and 4-month follow-up **Description:** Change in mean self-efficacy score (range: 2-6, higher=higher self-efficacy) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences) **Measure:** Self-efficacy to support someone experiencing intimate partner violence **Time Frame:** Baseline and 4-month follow-up **Description:** Change in mean self-efficacy score (range: 1-3, higher=higher self-efficacy) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences) **Measure:** Self-efficacy to seek formal intimate partner violence support services **Time Frame:** Baseline and 4-month follow-up #### Secondary Outcomes **Description:** Change in mean attitude score (range: 5-25, higher = more supportive attitudes) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences) **Measure:** Attitudes supportive of women's economic self-sufficiency **Time Frame:** Baseline and 4-month follow-up **Description:** Change in mean attitude score (range: 5-25, higher = more supportive attitudes) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences) **Measure:** Attitudes supportive of family planning use **Time Frame:** Baseline and 4-month follow-up **Description:** Change in mean attitude score (range: 6-30, higher=attitudes less accepting of reproductive coercion/improved attitudes) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences) **Measure:** Attitudes not accepting of reproductive coercion **Time Frame:** Baseline and 4-month follow-up **Description:** Change in mean attitude score (range: 10-50, higher = attitudes less accepting of intimate partner violence/improved attitudes) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences) **Measure:** Attitudes not accepting of intimate partner violence **Time Frame:** Baseline and 4-month follow-up **Description:** Change in mean group norm score based off individual attitudes scales aggregated at group (i.e. cluster) level (range: 5-25, higher = more supportive norms) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences) **Measure:** Group norms supportive of women's economic self-sufficiency **Time Frame:** Baseline and 4-month follow-up **Description:** Change in mean group norm score based off individual attitudes scales aggregated at group (i.e. cluster) level (range: 5-25, higher = more supportive norms) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences) **Measure:** Group norms supportive of family planning use **Time Frame:** Baseline and 4-month follow-up **Description:** Change in mean group norm score based off individual attitudes scales aggregated at group (i.e. cluster) level (range: 6-30, higher = norms less accepting of reproductive coercion/improved norms) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences) **Measure:** Group norms not accepting of reproductive coercion **Time Frame:** Baseline and 4-month follow-up **Description:** Change in mean group norm score based off individual attitudes scales aggregated at group (i.e. cluster) level (range: 10-50, higher = norms less accepting of intimate partner violence/improved norms) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences) **Measure:** Group norms not accepting of intimate partner violence **Time Frame:** Baseline and 4-month follow-up **Description:** Change in prevalence of awareness of intimate partner violence services between baseline and 4-month follow-up in intervention compared to control group (difference-in differences) **Measure:** Awareness of intimate partner violence services **Time Frame:** Baseline and 4-month follow-up **Description:** Change in mean knowledge score (range: 0-10, higher = more accurate knowledge) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences) **Measure:** Family planning knowledge **Time Frame:** Baseline and 4-month follow-up **Description:** Change in prevalence of knowledge of financial literacy resources between baseline and 4-month follow-up in intervention compared to control group (difference-in differences) **Measure:** Knowledge of financial literacy resources **Time Frame:** Baseline and 4-month follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Being a women's economic group member prior to baseline * Aged 15 years and older * Able to provide informed consent * Not planning to move out of the area or leave the women's economic group in the next 4 months Exclusion Criteria: * None **Gender Based:** True **Gender Description:** Self-report biologically female **Minimum Age:** 15 Years **Sex:** FEMALE **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** eepearson@health.ucsd.edu **Name:** Erin Pearson, PhD MPH **Phone:** 12546246937 **Role:** CONTACT **Contact 2:** **Email:** juysal@ucsd.edu **Name:** Jasmine Uysal, MPH **Phone:** 14259850772 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** University of California, San Diego **Name:** Jay G Silverman, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Open access **Description:** Will share de-identified quantitative participant data analysis sets to the Dryad public data repository upon publication of findings **Info Types:** - STUDY_PROTOCOL - ICF - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** Upon publication of findings ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M6494 - Name: Contraceptive Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414057 **Brief Title:** HPV Equity Study: Exploring Cervical Cancer Control in Scotland for Women With Experience of Priority Risks **Official Title:** HPV Equity Study: Exploring Cervical Cancer Control in Scotland for Women With Experience of Priority Risks #### Organization Study ID Info **ID:** AC23210 #### Organization **Class:** OTHER **Full Name:** University of Edinburgh ### Status Module #### Completion Date **Date:** 2025-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2023-12 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Edinburgh #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Individuals with experience of homelessness, substance use/addiction, transactional sex, and incarceration experience significant health inequities across a wide range of health conditions. This inequity includes cervical cancer with individuals in these populations less engaged with both routine human papillomavirus (HPV) vaccination and cervical cancer screening programmes, yet also at higher risk of developing cervical cancer. Opportunistic vaccination is recommended by the Joint Committee on Vaccination and Immunisation for 'other at risk/vulnerable groups' who may benefit (such as people with experience of transactional sex or incarceration) at clinical discretion. However, there is limited evidence on the feasibility, uptake, attitudes and impact of vaccination in these at-risk groups and no nationally funded programme. This mixed methods exploratory study seeks to generate evidence to inform the optimal service design. Core objectives are to: 1) assess the feasibility and acceptability of offering opportunistic HPV vaccination during standard sexual health care to women at high risk of HPV and cervical cancer; 2) identify the type-specific prevalence of HPV among recruited participants; and 3) describe participants' perceptions and experiences of accessing routine HPV vaccination and cervical screening services, and/or this opportunistic (research) service. The investigators will seek to recruit women with experience of homelessness, substance use/addiction, transactional sex, and incarceration. The study will include trans-men and non-binary people at risk of cervical cancer with the same risk experiences. Potential participants will be identified prospectively via attendance at specialist sexual health services in Scotland. Participants will be offered HPV vaccination and testing, and/or an in-depth research interview. Participation can be completed within one clinic visit. The full vaccination course is available via participation (min/max does spacing 6/12 months) and participants testing positive for high-risk type HPV can/will be followed up in full and supported in accessing treatment. **Detailed Description:** Component 1: Focusses on assessment of the prevalence of HPV in our study population, and on the provision, and assessment of the uptake, of HPV vaccination (gardesil-9). Intervention - HPV vaccination and self-swab screening will be offered to up to 500 individuals across the three study sites, aiming to recruit 120-180 individuals within each of the three participating health boards over a 6-9 month timeframe. Vaccine provision - All aspects of the vaccine provision in this study will be conducted in line with current clinical practice and follow the site's local GPD for HPV vaccine provision. The cost of vaccine provision in this study is being met by charitable donation of the standard vaccine by the pharmaceutical company (MSD). Vaccine - This study will use Gardasil-9, produced and provided by MSD. It is a nine valent vaccine offering protection against HPV types 6, 11, 16, 18, 31, 33, 45, 52 \& 58, and is the only vaccine available to use in the UK. Number of doses - The risk profile of the participant population is considered to be similar to that of GBMSM. Accordingly, participants will be offered 2/3 doses of the vaccine according to their immunocompetency. HPV testing - Participants will be asked to provide a baseline self-taken vaginal swab for HPV testing. Self-swab sampling is being offered as this is standard practice for Chlamydia and Gonorrhoea testing, increasing uptake for individuals who would decline an examination, such as those with experience of sexual trauma. If participants would rather not take a self-taken swab, then clinician taken sampling will be offered. Swab tests - This study will use the COPAN FloqSwabs™; pictorial instructions for sampling will be provided. Swabs will be dispatched to the Scottish HPV Reference Laboratory (SHPVRL) for HPV genotyping. Laboratory analysis - HPV genotyping will be performed using the AllplexT HPV 28 assay. Follow-up of HPV+ participants - All participants with a positive high-risk type HPV test on their swab will be contacted and advised that a liquid-based cytology (LBC) smear test is recommended. Travel expenses - Participants will be offered travel expenses (up to £25 in total) for attendance at the clinic for repeat vaccine doses or follow-up smear test. ----------------------------------- Component 2: consists of a qualitative exploration of the perspectives of women from our target population on HPV vaccination and screening. In-depth interview study - Investigators will conduct individual interviews with people invited to take part in the vaccine intervention study. This will include individuals who accepted the vaccine and screening and those who declined. Recruitment - Participants will be invited to consider taking part in a research interview at the same time as recruitment to component 1. This will include individuals who choose to undertake the vaginal sampling and HPV vaccination, or after refusing to do so. It will be made clear that this is an additional, optional, component and that the interview would be carried out by a University of Edinburgh researcher, and will be held a safe environment. Up to 30 interviews will be conducted across the three health boards, seeking to include a balance of participants from each of the eligible groups. Participants will be offered a £10 voucher in recognition of their time. The voucher will only be given following the completion of the interview. For participants currently living in custody, £10 will be added to their commissary account. Interview conduct - Interviews will be carried out by an experienced researcher and will explore topics related to cervical cancer/HPV risks, vaccination, and access to current vaccine and cervical screening services. Interviews will take a semi-structured format and the interviewer will be free to pursue any relevant line of conversation appearing to be of importance to that participant. Interviews will be carried out in a private space in person (in either the clinic facility/outreach facility) or via phone, or via the approved NHS digital remote consultation platform if the participant is currently in prison. Interviews will be recorded on an encrypted device and transcribed verbatim. Investigators will use a university approved company (First Class Secretarial Services) with a confidentiality and data-processing agreement in place, and transcripts will be checked for accuracy and fully anonymised by the Lead Research Fellow. Analysis - analysis will be undertaken using an abductive thematic approach (i.e. we will look for patterns, themes, and connections in participants' accounts. Investigators will commence coding and analysis with an outline codebook based on relevant established literature and theories, and will use new insights and perspectives gained directly from the data to add new codes and adapt the coding structure during the analytical process). The NVivo software (QSR NVivo version 10) will be used to store and organise the transcripts, and all coding and analysis undertaken. Interpretation - Individual member checking may be challenging for some participants however, PPI input to the interpretation and reporting of interview findings will be obtained from the study advisory panel which will include representatives from advocacy groups such as Jo's Cervical Cancer Trust, and the Waverly Centre. Where appropriate, the Research Fellow will attend advocacy groups to ensure participant group views are suitably represented in the interpretation of the results. ### Conditions Module **Conditions:** - Human Papilloma Virus ### Design Module #### Bio Spec **Description:** Vaginal swab for HPV genotyping **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Investigators will offer Gardasil-9 and HPV self-swab screening to up to 500 individuals across the three study sites, aiming to recruit 120-180 individuals within each of the three participating health boards over a 6-9 month timeframe. Participants will be asked to provide a vaginal swab sample for baseline HPV testing. **Intervention Names:** - Other: Offering opportunistic HPV vaccine during routine sexual health clinic visits **Label:** All participants ### Interventions #### Intervention 1 **Arm Group Labels:** - All participants **Description:** Investigators will offer Gardasil-9 and HPV self-swab screening to up to 500 individuals across the three study sites, aiming to recruit 120-180 individuals within each of the three participating health boards over a 6-9 month timeframe. Participants will be asked to provide a vaginal swab sample for baseline HPV testing. **Name:** Offering opportunistic HPV vaccine during routine sexual health clinic visits **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Number of participants taking up HPV screening and initial HPV vaccine dose during the clinic visit **Measure:** Uptake **Time Frame:** Baseline #### Secondary Outcomes **Description:** Proportion of participants who provide a self-taken vaginal swap/opt for a clinician-taken swab **Measure:** Clinician/self sampling **Time Frame:** Baseline **Description:** Number of participants completing vaccine schedule, assessed in line with JCVI guidance **Measure:** Vaccine completion **Time Frame:** 12 months **Description:** Number of participants testing HPV + for each sub-type **Measure:** HPV prevalence **Time Frame:** 4 weeks **Description:** Number of participants undertaking clinical follow-up after testing HPV + for high risk variant **Measure:** Follow-up tests **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Individuals will be eligible for participation in components 1 and/or 2 if they: * have a cervix * are aged 25-45 years (inclusive) * are able to provide informed consent for themself And have experience of either: * substance use/addiction * living in custodial settings * homelessness * involvement in transactional sex Exclusion Criteria: Individuals will be excluded from participation if they: * Do not have a cervix due to surgery or other reasons * Are known to have completed the full vaccination schedule (as per JCVI criteria for their age and immunocompetency) (Excluded from component 1 (vaccination and HPV screening) only - still able to participate in component 2 (individual interview)) * Meet any of the vaccine exclusion criteria as set out in the local HPV PGD * Have had a confirmed anaphylactic reaction to a previous dose of HPV vaccine. * Have had a confirmed anaphylactic reaction to any component of the vaccine. Practitioners must check the marketing authorisation holder's SmPC for details of vaccine components. * Have a history of severe (i.e. anaphylactic reaction) to latex where the vaccine is not latex free. * Are known to be pregnant. * Are suffering from an acute severe febrile illness (the presence of a minor infection is not a contraindication for immunisation). Additionally, PGDs advise caution where a neurological condition is believed to be progressing or there is neurological deterioration and therefore, individuals meeting this criteria will be excluded (from component 1 only). **Maximum Age:** 45 Years **Minimum Age:** 25 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT **Study Population:** Adult women, trans men, or non-binery individuals with a cervix attending routine sexual health services who aslo have experience of substance use/addiction, living in custodial settings, homelessness, or involvement in transactional sex. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** mia.closs@ed.ac.uk **Name:** Mia Closs, PhD **Phone:** 0131 650 1000 **Role:** CONTACT **Contact 2:** **Name:** Christine Campbell **Phone:** 0131 650 1000 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** University of Edinburgh **Name:** Christine Campbell **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Data will not be made available as we will be undertaking a follow-up study in 5-10 years **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009369 - Term: Neoplasms - ID: D000018307 - Term: Neoplasms, Squamous Cell - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type ### 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: BC01 - Name: Infections ### Condition Browse Module - Browse Leaves - ID: M13131 - Name: Papilloma - Relevance: HIGH - As Found: Papilloma - ID: M5830 - Name: Uterine Cervical Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M20451 - Name: Neoplasms, Squamous Cell - 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 ### Condition Browse Module - Meshes - ID: D000010212 - Term: Papilloma ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M17360 - Name: Vaccines - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414044 **Acronym:** STAR **Brief Title:** Italian Real-life obServational Study on the effecTiveness, sAfety and Tolerability of Atogepant in Migraine Patients **Official Title:** STudio Osservazionale Sull'Efficacia, Sicurezza e tollerabilità di Atogepant in Pazienti Real Life Affetti da Emicrania in Italia (Studio STAR) #### Organization Study ID Info **ID:** RICe_4 #### Organization **Class:** OTHER **Full Name:** University of Florence ### Status Module #### Completion Date **Date:** 2026-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-09 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Fondazione Policlinico Universitario Campus Bio-Medico **Class:** OTHER **Name:** IRCCS National Neurological Institute "C. Mondino" Foundation **Class:** UNKNOWN **Name:** Società italiana per lo studio delle Cefalee (SISC) **Class:** OTHER **Name:** Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari **Class:** OTHER **Name:** Università degli Studi dell'Aquila **Class:** OTHER **Name:** University of Roma La Sapienza **Class:** OTHER **Name:** Azienda Ospedaliero Universitaria Policlinico Modena **Class:** UNKNOWN **Name:** Euganea Health Unit, Padua, Italy **Class:** OTHER **Name:** Azienda Ospedaliero-Universitaria di Parma **Class:** OTHER **Name:** Azienda Ospedaliera S. Maria della Misericordia **Class:** OTHER **Name:** Azienda Ospedaliera Città della Salute e della Scienza di Torino **Class:** OTHER **Name:** Cliniche Humanitas Gavazzeni **Class:** OTHER **Name:** University of Campania "Luigi Vanvitelli" **Class:** UNKNOWN **Name:** Ospedale di Prato **Class:** OTHER **Name:** Azienda Policlinico Umberto I **Class:** UNKNOWN **Name:** Auxologico San Luca, Milano **Class:** UNKNOWN **Name:** ASST Spedali Civili, Brescia #### Lead Sponsor **Class:** OTHER **Name:** University of Florence #### Responsible Party **Investigator Affiliation:** University of Florence **Investigator Full Name:** Luigi Francesco Iannone **Investigator Title:** Researcher at the Headache Center and Clinical Pharmacology Unit and at the Department of Health Sciences, University of Florence, Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of atogepant as preventive migraine treatment in a cohort of episodic or chronic migraine patients. **Detailed Description:** Atogepant is a small molecule calcitonin gene- related peptide (CGRP) receptor antagonist, part of the gepants family. It is a second generation gepant, currently approved for the preventive treatment of episodic and chronic migraine. Previously randomized, placebo-controlled phase 2/3 trials demonstrated its effectiveness and tolerability in the preventive setting for patients with episodic and chronic migraine, associated with a good tolerability profile. The most commonly reported adverse events were upper respiratory tract infections, urinary infections, nausea and constipation. In this prospective multicentric study the investigators aim to evaluate atogepant effectiveness and tolerability as preventive migraine treatment in a real-world setting. Subjects who meet the inclusion criteria will be enrolled and will participate in the study. Baseline demographic and clinical data will be collected at the baseline. patients will take atogepant 60 mg daily for at least 12 weeks up to two years, according to effectiveness, tolerability and eventual approval of reimbursability criteria. Data will be collected at baseline and every three months for two years. Subjects will be asked to keep a headache diary to collect monthly headache and migraine days, migraine severity, associated symptoms and drug consumption. Questionnaires will be collected every three months. Data collection will focus on: i) demographic data, ii) migraine history, iii) pain intensity, iv) presence and evolution of migraine associated symptoms and aura, v) migraine associated disability, vi) tolerability and eventual treatment- emergent adverse events, vii) treatment persistence. The online database REDCap will be used for data collection. ### Conditions Module **Conditions:** - Migraine - Migraine With Aura - Migraine Without Aura - Chronic Migraine **Keywords:** - Headache - Medication overuse headache - Pain - Migraine prevention - Gepant ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients affected by migraine with an episodic pattern (\< 15 monthly migraine days) with or without aura according to ICHD-III criteria. **Intervention Names:** - Drug: Atogepant 60 mg **Label:** Episodic migraine #### Arm Group 2 **Description:** Patients affected by chronic migraine (\> 15 monthly headache days with at least 8 days with migraine features) according to ICHD-III criteria. **Intervention Names:** - Drug: Atogepant 60 mg **Label:** Chronic migraine ### Interventions #### Intervention 1 **Arm Group Labels:** - Chronic migraine - Episodic migraine **Description:** Patients using atogepant 60 mg tablet daily as migraine prevention **Name:** Atogepant 60 mg **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Changes in monthly migraine days with aura across treatment (continuous variable, through headache diary assessment) **Measure:** Changes in the number of monthly migraine days with aura (quantitative) **Time Frame:** Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant **Description:** Changes in duration of aura across atogepant treatment (continuous variable - minutes, assessed through headache diary) **Measure:** Variation of duration of aura (qualitative) **Time Frame:** Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant **Description:** Changes in type of aura across atogepant treatment (qualitative variable - assessed through headache diary and anamnestic data collection) **Measure:** Variation of type of aura (qualitative) **Time Frame:** Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant **Description:** Change of monthly migraine days across treatment in those patients who did not respond to anti-CGRP mAbs (continuous variable) **Measure:** MMDs reduction in patients Non-responders to mAbs **Time Frame:** Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant **Description:** Percentage of 50% Responders across treatment in those patients who did not respond to anti-CGRP mAbs (continuous variable) **Measure:** Percentage of 50% Responders across treatment in patients Non-responders to mAbs **Time Frame:** Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant **Description:** Change in the number of menstrually-related attacks (according to ICHD-3) across treatment compared to baseline (continuous variable) **Measure:** Menstrually-related migraine **Time Frame:** Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant **Description:** Change in Patients Global Impression of Change (PGIC) questionnaire across treatment (continuous variable, scale 0-7, 1 very much improved, 2 much improved, 3 minimally improved, 4 no change, 5 minimally worse, 6 much worse, 7 very much worse) **Measure:** Change in self-reported effectiveness of treatment **Time Frame:** Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant **Description:** Changes in migraine severity (continuous variable, 0-10 numerical rating scale, higher scores indicate higher severity) **Measure:** Changes in migraine severity **Time Frame:** Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant **Description:** Changes in migraine duration (continuous variable- hours- assessed through a paper diary) **Measure:** Changes in migraine duration **Time Frame:** Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant **Description:** Changes in duration of the most bothersome symptom(s) across treatment (continuous variable, minutes, assessed through a paper diary) **Measure:** Changes in duration of the most bothersome symptom(s) **Time Frame:** Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant **Description:** Changes in severity of the most bothersome symptom(s) across treatment (continuous variable: 0-10 scale, higher scores indicate higher severity ) **Measure:** Changes in severity of the most bothersome symptom(s) **Time Frame:** Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant #### Primary Outcomes **Description:** Changes in monthly migraine days after three months of treatment with atogepant compared to baseline (continuous variable) **Measure:** Changes in migraine frequency after three months of treatment **Time Frame:** Baseline (T0) - 3 months of treatment with atogepant (T3) **Description:** Percentage of 50% Responders (namely patients who presented a reduction of MMDs \>/ = 50% compared to baseline) after three months of treatment with atogepant (continuous variable) **Measure:** 50% Response after three months of treatment **Time Frame:** Baseline (T0) - 3 months of treatment with atogepant (T3) #### Secondary Outcomes **Description:** Changes in monthly migraine days after six and twelve months of treatment with atogepant compared to baseline (continuous variable) **Measure:** Changes in migraine frequency across twelve months of atogepant treatment **Time Frame:** Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with atogepant **Description:** Percentage of 50% Responders (namely patients who presented a reduction of MMDs \>/ = 50% compared to baseline) after six and twelve months of treatment with atogepant (continuous variable) **Measure:** Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) across twelve months of treatment with atogepant **Time Frame:** Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with atogepant **Description:** Type of any adverse events in patients receiving atogepant during the observation period (categorical variable) **Measure:** Evaluation of any adverse event (qualitative) **Time Frame:** Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant **Description:** Percentage of reported adverse events in patients receiving atogepant assessed quarterly during the observation period (continuous variable) **Measure:** Evaluation of any adverse event (quantitative) **Time Frame:** Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant **Description:** Percentage of serious adverse events (namely those resulting in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect) in patients receiving atogepant during the observation period (continuous variable) **Measure:** Evaluation of serious adverse event **Time Frame:** Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant **Description:** Percentage of adverse events leading to treatment discontinuation in patients receiving atogepant during the observation period (continuous variable) **Measure:** Evaluation of adverse event leading to treatment discontinuation **Time Frame:** Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant **Description:** Percentage of patients with a stable 50% response across twelve months of atogepant treatment (continuous variable) **Measure:** Consistency of treatment response **Time Frame:** Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant **Description:** Changes in MIgraine Disability ASsement questionnaire across treatment (continuous variable, 0-270 scale, higher scores indicate higher disability: 0-5, little/no disability; 6-10, mild disability; 11-20, moderate disability; \>20, severe disability) **Measure:** Changes in migraine disability (MIDAS) **Time Frame:** Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant **Description:** Changes in Headache Impact Test-6 questionnaire across treatment (continuous variable, 36-78 scale, higher scores indicates greater disability) **Measure:** Changes in migraine disability (HIT-6) **Time Frame:** Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant **Description:** Changes in migraine Treatment Optimization Questionnaire across treatment (continuous variable, 0-8 scale, higher score indicates higher acute therapy effectiveness) **Measure:** Changes in response to acute migraine treatment (m-TOQ) **Time Frame:** Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant **Description:** Changes in Allodynia Symptoms Checklist-12 questionnaire across treatment (continuous variable, 0-24 scale, higher score indicates more severe allodynia) **Measure:** Changes in allodynia (ASC-12) **Time Frame:** Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant **Description:** Changes in Migraine Specific Quality of life questionnaire across treatment (continuous variable, 0-100 scale, 100 indicates full functionality) **Measure:** Changes in quality of life across atogepant treatment (MSQ) **Time Frame:** Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant **Description:** Changes in Migraine Interictal Burden Scale-4 questionnaire across treatment (continuous variable, 0-4 scale, 0 indicates no interictal burden, 1-2 mild level of interictal burden, 3 moderate interictal burden, 4 severe interictal burden) **Measure:** Changes in interictal burden across atogepant treatment (MIBS-4) **Time Frame:** Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant **Description:** Changes in Migraine Assessment of Current Therapy (Migraine-ACT) a 4-item questionnaire about treatment effectiveness and daily life repercussions, across treatment compared to baseline (continuous variable, 0-4 scale, higher scores indicates higher acute treatment effectiveness) **Measure:** Self-reported treatment effectiveness **Time Frame:** Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant **Description:** Percentage of patients with a baseline diagnosis of MOH reverted after 3 - 6 and 12 months of treatment (continuous variable) **Measure:** Percentage of patients with Medication overuse headache reverted during treatment **Time Frame:** Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with atogepant ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosis of migraine without aura, migraine with aura, or chronic migraine according to the 3rd edition of the International Classification of Headache Disorder (ICHD-III); * At least 3 monthly migraine days; * Good compliance to study procedures; * Availability of headache diary at least of the preceding months before enrollment. Exclusion Criteria: * Subjects with contraindications for use of gepants; * Concomitant diagnosis of medical diseases and/or comorbidities that, in the Investigator's opinion might interfere with study assessments; * medical comorbidities that could interfere with study results; * Pregnancy and breastfeeding. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Multicentric study on patients attending the outpatient clinic of Italian Headache centres who meet criteria for atogepant use for migraine preventive treatment. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** luigifrancesco.iannone@unifi.it **Name:** Luigi F Iannone, MD **Phone:** +393896969606 **Role:** CONTACT **Contact 2:** **Email:** f.vernieri@policlinicocampus.it **Name:** Fabrizio Vernieri, MD **Role:** CONTACT #### Locations **Location 1:** **City:** Florence **Contacts:** ***Contact 1:*** - **Email:** luigifrancesco.iannone@unifi.it - **Name:** Luigi F Iannone, MD - **Role:** CONTACT **Country:** Italy **Facility:** SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi **Status:** RECRUITING **Zip:** 50134 **Location 2:** **City:** Roma **Contacts:** ***Contact 1:*** - **Name:** Fabrizio Vernieri - **Role:** CONTACT **Country:** Italy **Facility:** Fondazione Policlinico Campus Bio-Medico **Status:** RECRUITING **Zip:** 00128 ### References Module #### References **Citation:** Pozo-Rosich P, Ailani J, Ashina M, Goadsby PJ, Lipton RB, Reuter U, Guo H, Schwefel B, Lu K, Boinpally R, Miceli R, De Abreu Ferreira R, McCusker E, Yu SY, Severt L, Finnegan M, Trugman JM. Atogepant for the preventive treatment of chronic migraine (PROGRESS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Sep 2;402(10404):775-785. doi: 10.1016/S0140-6736(23)01049-8. Epub 2023 Jul 26. Erratum In: Lancet. 2023 Sep 2;402(10404):774. Lancet. 2023 Oct 14;402(10410):1328. **PMID:** 37516125 **Citation:** Goadsby PJ, Dodick DW, Ailani J, Trugman JM, Finnegan M, Lu K, Szegedi A. Safety, tolerability, and efficacy of orally administered atogepant for the prevention of episodic migraine in adults: a double-blind, randomised phase 2b/3 trial. Lancet Neurol. 2020 Sep;19(9):727-737. doi: 10.1016/S1474-4422(20)30234-9. Erratum In: Lancet Neurol. 2020 Nov;19(11):e10. **PMID:** 32822633 **Citation:** Schwedt TJ, Lipton RB, Ailani J, Silberstein SD, Tassorelli C, Guo H, Lu K, Dabruzzo B, Miceli R, Severt L, Finnegan M, Trugman JM. Time course of efficacy of atogepant for the preventive treatment of migraine: Results from the randomized, double-blind ADVANCE trial. Cephalalgia. 2022 Jan;42(1):3-11. doi: 10.1177/03331024211042385. Epub 2021 Sep 14. **PMID:** 34521260 **Citation:** Tassorelli C, Nagy K, Pozo-Rosich P, Lanteri-Minet M, Sacco S, Nezadal T, Guo H, De Abreu Ferreira R, Forero G, Trugman JM. Safety and efficacy of atogepant for the preventive treatment of episodic migraine in adults for whom conventional oral preventive treatments have failed (ELEVATE): a randomised, placebo-controlled, phase 3b trial. Lancet Neurol. 2024 Apr;23(4):382-392. doi: 10.1016/S1474-4422(24)00025-5. Epub 2024 Feb 13. **PMID:** 38364831 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000051270 - Term: Headache Disorders, Primary - ID: D000020773 - Term: Headache Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC25 - Name: Substance Related Disorders - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9351 - Name: Headache - Relevance: LOW - As Found: Unknown - ID: M11852 - Name: Migraine Disorders - Relevance: HIGH - As Found: Migraine - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M22135 - Name: Migraine without Aura - Relevance: HIGH - As Found: Migraine Without Aura - ID: M22134 - Name: Migraine with Aura - Relevance: HIGH - As Found: Migraine With Aura - ID: M151 - Name: Prescription Drug Overuse - Relevance: LOW - As Found: Unknown - ID: M22529 - Name: Headache Disorders - Relevance: LOW - As Found: Unknown - ID: M26657 - Name: Headache Disorders, Primary - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008881 - Term: Migraine Disorders - ID: D000020326 - Term: Migraine without Aura - ID: D000020325 - Term: Migraine with Aura ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414031 **Acronym:** TATRA **Brief Title:** Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery **Official Title:** Tranexamic Acid for Reduction of Intra- and Postoperative Transfusion Requirements in Elective Abdominal Surgery: Randomized Controlled Trial #### Organization Study ID Info **ID:** TATRA #### Organization **Class:** OTHER **Full Name:** Martin-Luther-Universität Halle-Wittenberg ### Status Module #### Completion Date **Date:** 2025-11-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-11-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** German Federal Ministry of Education and Research **Class:** UNKNOWN **Name:** Coordinating Centre for Clinical Trials Halle #### Lead Sponsor **Class:** OTHER **Name:** Ulrich Ronellenfitsch, MD #### Responsible Party **Investigator Affiliation:** Martin-Luther-Universität Halle-Wittenberg **Investigator Full Name:** Ulrich Ronellenfitsch, MD **Investigator Title:** Professor of Evidence-based Abdominal Surgical Oncology **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this clinical trial is to learn if the administration of tranexamic acid can reduce the necessity of blood transfusions in adult patients undergoing major abdominal surgery. . It will also inform about safety of tranexamic acid in this setting. The main question it aims to answer is: Does tranexamic acid lower the probability of receiving at least one blood transfusion during or after surgery? Participants will compare tranexamic acid o a placebo (a look-alike substance that contains no drug) to see if tranexamic acid works to reduce the necessity of a blood transfusion. ### Conditions Module **Conditions:** - Surgical Blood Loss - Transfusion-dependent Anemia - Abdomen Disease ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 850 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Intravenous administration of tranexamic acid (1 g bolus 10 minutes prior to skin incision followed by continuous infusion 125 mg / hour until skin closure) **Intervention Names:** - Drug: Tranexamic Acid **Label:** Tranexamic acid **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Intravenous administration of placebo (normal saline), 50 ml bolus 10 minutes prior to skin incision followed by continuous infusion of 6.25 ml / hour until skin closure. **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Tranexamic acid **Description:** Intravenous administration **Name:** Tranexamic Acid **Other Names:** - Tranexamsäure Carinopharm 100mg/ml **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Intravenous administration **Name:** Placebo **Other Names:** - Isotone Kochsalz-Lösung 0,9% Infusionslösung **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Intra- or postoperative transfusion of at least one unit of packed red blood cells **Measure:** Transfusion necessity **Time Frame:** Until hospital discharge or 30 days postoperatively, whatever occurs earlier #### Secondary Outcomes **Description:** Number of transfused units of packed red blood cells per patient **Measure:** Transfusion amount **Time Frame:** Until hospital discharge or 30 days postoperatively, whatever occurs earlier **Description:** Estimated intraoperative blood loss **Measure:** Blood loss **Time Frame:** From skin incision to suture **Description:** Postoperative complications and mortality assessed according to the Clavien-Dindo scheme **Measure:** Postoperative complications and mortality **Time Frame:** Until hospital discharge or 30 days postoperatively, whatever occurs earlier **Description:** Time period from hospital admission to discharge **Measure:** Length of hospital stay **Time Frame:** From hospital admission to discharge **Description:** Time period from skin incision to suture **Measure:** Operation time **Time Frame:** From skin incision to suture **Description:** Time period from anesthesia induction to end of anesthesia **Measure:** Anesthesia time **Time Frame:** From anesthesia induction to end of anesthesia **Description:** Serum levels of D-dimers **Measure:** D-dimer levels **Time Frame:** Until hospital discharge or 30 days postoperatively, whatever occurs earlier **Description:** Any adverse event attributed to the intervention comprising anaphylaxis, thromboembolic events, acute renal failure, acute heart failure, seizures **Measure:** Adverse events **Time Frame:** Until hospital discharge or 30 days postoperatively, whatever occurs earlier ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age 18 years or above 2. Planned elective esophagectomy, gastrectomy, colectomy, rectal resection, pancreatic resection, or hepatectomy 3. Adequate renal function with serum creatinine \<250 µmol/L (2.82 mg/dL) 4. Written informed consent obtained before randomization 5. Negative pregnancy test for women of childbearing potential within 14 days of commencing study treatment. Females of reproductive potential must agree to practice highly effective contraceptive measures during the study. These comprise measures with a failure rate of \<1% per year when used consistently and correctly, such as intravaginal and transdermal combined (oestrogen and progestogen containing) hormonal contraception, injectable and implantable progestogen-only hormonal contraception, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion; vasectomised partner, sexual abstinence (defined as refraining from heterosexual intercourse during the entire study period). Exclusion Criteria: 1. Severe anaemia, defined as a haemoglobin concentration \<8 g/dL (\<5 mmol/L) or anaemia with haemoglobin concentration ≥8 to \<10 g/dL (≥5,0 to \<6,2 mmol/l) and one or several of the following symptoms suggesting hypoxemia: * Clinical signs of tachycardia, e.g., resting heart rate \>100 beats/minute, palpitation etc. * Clinical signs of hypotension, e.g., resting systolic blood pressure \<100 mmHg, orthostatic dysregulation etc. * Clinical signs of dyspnea, e.g., speech dyspnea, resting respiratory rate \>20 breaths/min. 2. Thrombocytopenia with platelets \<60 x 109 /L 3. Confirmed bleeding disorder with the need for specific preventive perioperative treatment (e.g., factor deficiency with the need of perioperative substitution) 4. A priori refusal of blood transfusions 5. Confirmed thrombophilia with a pertinent need for perioperative anticoagulation 6. Allergy / hypersensitivity to tranexamic acid 7. Recent (\<30 days) thromboembolic event 8. History of medically confirmed convulsions 9. In female subjects: pregnancy or lactation **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ulrich.ronellenfitsch@uk-halle.de **Name:** Ulrich Ronellenfitsch, MD **Phone:** +493455572327 **Role:** CONTACT #### Locations **Location 1:** **City:** Halle (Saale) **Contacts:** ***Contact 1:*** - **Email:** ulrich.ronellenfitsch@uk-halle.de - **Name:** Ulrich Ronellenfitsch, MD - **Phone:** +49-345-5572327 - **Role:** CONTACT **Country:** Germany **Facility:** University Hospital, Dpt. of Abdominal, Vascular and Endocrine Surgery **Zip:** 06120 #### Overall Officials **Official 1:** **Affiliation:** Medical Faculty of the Martin Luther University Halle-Wittenberg **Name:** Ulrich Ronellenfitsch, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006470 - Term: Hemorrhage - ID: D000010335 - Term: Pathologic Processes - ID: D000007431 - Term: Intraoperative Complications ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC15 - Name: Blood and Lymph Conditions ### Condition Browse Module - Browse Leaves - ID: M9556 - Name: Hemorrhage - Relevance: LOW - As Found: Unknown - ID: M4070 - Name: Anemia - Relevance: LOW - As Found: Unknown - ID: M18560 - Name: Blood Loss, Surgical - Relevance: HIGH - As Found: Surgical Blood Loss - ID: M10465 - Name: Intraoperative Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016063 - Term: Blood Loss, Surgical ### Intervention Browse Module - Ancestors - ID: D000000933 - Term: Antifibrinolytic Agents - ID: D000050299 - Term: Fibrin Modulating Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000006490 - Term: Hemostatics - ID: D000003029 - Term: Coagulants ### Intervention Browse Module - Browse Branches - Abbrev: Coag - Name: Coagulants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M16902 - Name: Tranexamic Acid - Relevance: HIGH - As Found: Stage IV - ID: M4252 - Name: Antifibrinolytic Agents - Relevance: LOW - As Found: Unknown - ID: M9576 - Name: Hemostatics - Relevance: LOW - As Found: Unknown - ID: M6259 - Name: Coagulants - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000014148 - Term: Tranexamic Acid ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414018 **Acronym:** EOEDSAAIBT **Brief Title:** Effect of Equivalent Dose Sufentanil and Afentanil in Bronchoscopic Treatment **Official Title:** Effect Observation of Equivalent Dose Sufentanil and Afentanil Combined Laryngeal Mask for Complex Bronchoscopic Treatment #### Organization Study ID Info **ID:** EEDSA #### Organization **Class:** OTHER **Full Name:** Tongji Hospital ### Status Module #### Completion Date **Date:** 2025-02-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Xinxiang Central Hospital #### Lead Sponsor **Class:** OTHER **Name:** Tongji Hospital #### Responsible Party **Investigator Affiliation:** Tongji Hospital **Investigator Full Name:** aijun xu **Investigator Title:** clincal doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The equivalent dose of sufentanil and afentanil combined with laryngeal mask was used for complex bronchoscopy to observe the intraoperative effect and the influence on the recovery of patients **Detailed Description:** Afentanil is a powerful, fast-acting narcotic analgesic, which can effectively inhibit intubation reflex. Compared with sufentanil, it has a short half-life and is safer, and can be used as the first choice for short surgical analgesics. In this study, by comparing the use of equivalent dose sufentanil and afentanil combined with laryngeal mask for complex bronchoscopy, the intraoperative analgesic effect and the influence on the recovery of patients were observed, and a better anesthesia scheme was provided for tracheoscopy. ### Conditions Module **Conditions:** - Effect of Drug **Keywords:** - Afentanil - sufentanil - bronchoscopy - Recovery time ### 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:** 80 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The dose of sufentanil group is 0.2μg/kg **Intervention Names:** - Drug: Alfentanil **Label:** Sufentanil group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The dose of aifentanil group is 10μg/kg **Intervention Names:** - Drug: Alfentanil **Label:** Alfentanil **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Alfentanil - Sufentanil group **Description:** alfentanil 10ug/kg is used for anesthesia induction **Name:** Alfentanil **Other Names:** - sufentanil **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Airway obstruction, hypoxemia, apnea, laryngeal spasm, bronchospasm, cough, postoperative nausea and vomiting, postoperative pain (VAS score), hypotension, bradycardia, dizziness **Measure:** Postoperative adverse reaction **Time Frame:** 1 day #### Primary Outcomes **Description:** the time from the end of surgery to awake of patient **Measure:** Recovery time **Time Frame:** 1day #### Secondary Outcomes **Description:** Anesthesia time, induction time, surgical time, awakening time and recovery time **Measure:** Time records **Time Frame:** 1 day **Description:** The total amount of sedative and analgesic drugs used. **Measure:** dose of drugs **Time Frame:** 1 day **Description:** Respiratory frequency\<8 times/min or SP02\<90% **Measure:** Respiratory suppression incidence **Time Frame:** 1 day **Description:** Intraoperative blood pressure and heart rate changes: record the patient's intraoperative blood pressure, heart rate, and the use of related vasoactive drugs; Postoperative adverse reactions: such as hypertension, hypotension, tachycardia, gastrointestinal symptoms, postoperative restlessness, etc **Measure:** Incidence of Treatment-Emergent Adverse Events **Time Frame:** 1day ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 18-80, * ASA I-III level; * BMI 18.5\~23.9; Exclusion Criteria: * Patients with full stomach and high risk of reflux aspiration; * Allergic to benzodiazepines, opioids, rocuronium bromide; * Those who have taken sedative, analgesic or antidepressant drugs within 24 hours; * Pregnant and lactating women; * severe liver and kidney dysfunction; * Patients with severe anemia and hypoproteinemia; * Previous drug use history; * Recently participated in other clinical studies; * Patients who cannot cooperate with communication. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** changmujun@hotmial.com **Name:** mujun chang, doctor **Phone:** 86-27-83663625 **Role:** CONTACT **Contact 2:** **Email:** ahdu@tjh.tjmu.edu.cn **Name:** aihua du, doctor **Phone:** 86-27-83663625 **Role:** CONTACT #### Locations **Location 1:** **City:** Hubei **Country:** China **Facility:** Aijun Xu **State:** Wuhan **Zip:** 430000 #### Overall Officials **Official 1:** **Affiliation:** Tongji Hospital **Name:** aijun xu, Dr **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** You can request it from the main researcher. **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000000701 - Term: Analgesics, Opioid - ID: D000009294 - Term: Narcotics - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000700 - Term: Analgesics - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000000759 - Term: Adjuvants, Anesthesia - ID: D000018686 - Term: Anesthetics, Intravenous - ID: D000018681 - Term: Anesthetics, General - ID: D000000777 - Term: Anesthetics ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AdjAn - Name: Adjuvants, Anesthesia - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M19684 - Name: Sufentanil - Relevance: HIGH - As Found: Appointment - ID: M18320 - Name: Alfentanil - Relevance: HIGH - As Found: Magnetic Resonance Spectroscopy - ID: M117729 - Name: Dsuvia - Relevance: LOW - As Found: Unknown - 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 - ID: M4089 - Name: Adjuvants, Anesthesia - Relevance: LOW - As Found: Unknown - ID: M20766 - Name: Anesthetics, Intravenous - Relevance: LOW - As Found: Unknown - ID: M20761 - Name: Anesthetics, General - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000017409 - Term: Sufentanil - ID: D000015760 - Term: Alfentanil ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06414005 **Brief Title:** A Phase 2b/3 Study of TPX-115 on Partial-thickness Rotator Cuff Tear **Official Title:** A Multi-center, Randomized, Double Blinded, Placebo-controlled, Phase 2b/3 Clinical Trial to Evaluate the Safety and Efficacy of TPX-115 in Patients With Partial-thickness Rotator Cuff Tear #### Organization Study ID Info **ID:** TG-TPX-115-22-02 #### Organization **Class:** INDUSTRY **Full Name:** Tego Science, Inc. ### Status Module #### Completion Date **Date:** 2027-01-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-15 **Type:** ACTUAL **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Tego Science, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Rotator cuff tear is one of the most common shoulder diseases and conservative treatment is commonly used for tears involving ≤50% of tendon thickness. Since conventional conservative treatments are not fundamental to repair tendon tissue, there is a growing need of new therapy to improve structural outcome. This study assesses the safety and efficacy of allogeneic fibroblasts on partial-thickness rotator cuff tear. The primary outcome is change in Constant Score (CS) at 24 weeks after TPX-115 injection. Secondary outcomes include changes from baseline in CS, Visual Analogue Score (VAS) pain score, American Shoulder and Elbow Surgeons (ASES) score, Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH), Simple Shoulder Test (SST), and functional evaluations including Range of Motion (ROM) at 4, 12, 24 and 52 weeks after administration and structural evaluation using MRI at 24 and 52 weeks after injection. ### Conditions Module **Conditions:** - Partial Thickness Rotator Cuff Tear ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 166 **Type:** ESTIMATED **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects receive ultrasound-guided intratendinous injection of TPX-115 **Intervention Names:** - Biological: TPX-115 **Label:** TPX-115 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Subjects receive ultrasound-guided intratendinous placebo injection **Intervention Names:** - Other: Placebo (Saline) **Label:** Placebo (Saline) **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - TPX-115 **Description:** Ultrasound-guided intratendinous injection of allogeneic fibroblasts (TPX-115) **Name:** TPX-115 **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Placebo (Saline) **Description:** Ultrasound-guided intratendinous placebo injection **Name:** Placebo (Saline) **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The CS total score (100) = Pain (15) + Activity of Daily Living (20) + Mobility (40) + Strength(25) **Measure:** Change in shoulder score of Constant score (CS) **Time Frame:** 24 weeks #### Secondary Outcomes **Description:** The CS total score (100) = Pain (15) + Activity of Daily Living (20) + Mobility (40) + Strength(25). **Measure:** Change in shoulder score of Constant score (CS) **Time Frame:** 4, 12, 52 weeks **Description:** VAS pain score is measured on a scale of 0 (no pain) to 10 (worst pain imaginable). **Measure:** hange in pain score of Visual Analogue Scale (VAS) **Time Frame:** 4, 12, 24, 52 weeks **Description:** ASES shoulder score is derived from the visual analogue scale score for pain and the activities of daily living score. The total score(100 maximum points) is weighted 50% for pain and 50% for function. **Measure:** Change of American Shoulder and Elbow Surgeons (ASES) Shoulder Score **Time Frame:** 4, 12, 24, 52 weeks **Description:** The QuickDASH is a shortened version of the DASH Outcome Measure. Instead of 30 items, the QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. **Measure:** Change of Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH) Outcome Measure **Time Frame:** 4, 12, 24, 52 weeks **Description:** SST assesses functional disability of the shoulder (function related to pain, function/strength and Range of Motion). **Measure:** Change in Simple Shoulder Test (SST) Score **Time Frame:** 4, 12, 24, 52 weeks **Description:** Measurement of ROM for forward elevation, external rotation at 90º abduction, external rotation at side and internal rotation at back. **Measure:** Change in Range of Motion (ROM) **Time Frame:** 4, 12, 24, 52 weeks **Description:** Ellman grade is assessed by an independent evaluator. **Measure:** Change in Ellman grade on Magnetic Resonance Image (MRI) **Time Frame:** 24, 52 weeks **Description:** Tendinosis is assessed with tendinosis grading system by an independent evaluator. (0: normal, 1: mild, 2: moderate, 3: marked) **Measure:** Change of tendinosis on MRI **Time Frame:** 24, 52 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Be 19 years of age or older. 2. Have partial-thickness rotator cuff tear, ≤50% of tendon thickness or of Ellman grade II assessed by MRI. 3. Have unilateral shoulder pain, muscle weakness and limited active range of motion lasting more than 3 months despite conservative treatment 4. VAS pain score ≥4 at screening. 5. Understand fully the study and voluntarily sign the informed consent for participation in the study. Exclusion Criteria: 1. Regardless of partial-thickness rotator cuff tear, have full-thickness rotator cuff tear confirmed by MRI. 2. Have been treated with the following * Have had painkiller within 1 week prior to screening visit. * Have had received systemic steroid or immunosuppressive agents within 4 weeks prior to screening visit. * Have had subacromial or intra-articular injections on the affected shoulder within 3 months prior to screening visit. * Have shoulder surgery on the rotator cuff tear or had received drug that included growth factor, within 6 months prior to screening visit. 3. Have been diagnosed with the following diseases. * Inflammatory joint diseases * Other shoulder diseases which may cause shoulder pain or functional disorder * Autoimmune diseases * Active hepatitis B or C * HIV Ab positive * Malignant tumors within the last 5 years * Coagulopathy * Genetic disorders related to fibroblasts of collagen * Other serious diseases deemed to affect the results of the study 4. Have allergies to bovine proteins or gentamicin. 5. Be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptive suggested in this study. 6. Have participated in other clinical trials and received investigational agents within 4 weeks of this study. 7. Be deemed inadequate for the study by investigators. **Minimum Age:** 19 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jhhan@tegoscience.com **Name:** Jikhyon Han, Ph.D. **Phone:** +82-2-818-2900 **Role:** CONTACT #### Locations **Location 1:** **City:** Seongnam-si **Contacts:** ***Contact 1:*** - **Name:** Joo Han Oh, Professor - **Role:** CONTACT **Country:** Korea, Republic of **Facility:** Seoul National University Bundang Hospital **State:** Gyeonggi-do **Status:** RECRUITING **Zip:** 13620 #### Overall Officials **Official 1:** **Affiliation:** Seoul National University Bundang Hospital **Name:** Joo Han Oh, M.D. **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012421 - Term: Rupture - ID: D000014947 - Term: Wounds and Injuries - ID: D000070599 - Term: Shoulder Injuries - ID: D000013708 - Term: Tendon Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M15241 - Name: Rupture - Relevance: LOW - As Found: Unknown - ID: M22785 - Name: Lacerations - Relevance: LOW - As Found: Unknown - ID: M624 - Name: Rotator Cuff Injuries - Relevance: HIGH - As Found: Rotator Cuff Tears - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M602 - Name: Shoulder Injuries - Relevance: LOW - As Found: Unknown - ID: M16479 - Name: Tendon Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000070636 - Term: Rotator Cuff Injuries ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413992 **Brief Title:** Camrelizumab Plus Fluzoparib for TP-53 Mutated Endometrial Cancer **Official Title:** Efficacy and Safety of Camrelizumab Plus Albumin-bound Paclitaxel/Carboplatin Followed by Camrelizumab With or Without Fluzoparib Maintenance Therapy for TP-53 Mutated Recurrent or Metastatic Endometrial Cancer: A Phase II Trial #### Organization Study ID Info **ID:** CAFE #### Organization **Class:** OTHER **Full Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences ### Status Module #### Completion Date **Date:** 2027-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-10 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-23 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences #### Responsible Party **Investigator Affiliation:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences **Investigator Full Name:** GUANG WEN YUAN **Investigator Title:** Professor, M.D. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study is an open-label Phase II randomized controlled trial designed to evaluate the safety and efficacy of camrelizumab plus fluzoparib maintenance therapy in patients with recurrent or metastatic TP-53 mutated Endometrial Cancer. The study will also explore the prevalence of homologous recombination reficiency in Chinese patients with TP-53 mutated endometrial cancer and its therapeutic significance. **Detailed Description:** The treatment of recurrent or metastatic endometrial carcinoma (R/M-EC) has entered the era of molecular marker oriented precision therapy. Meanwhile, several large multicenter Phase III RCT studies have been conducted, such as NRG-GY018, RUBY, DUO-E and AtTEnd, and suggested that chemotherapy combined with immunotherapy could significantly improve the prognosis of R/M-EC. Unfortunately, the efficacy of ICBs in Asian R/M-EC population is not obvious, with small size. On the other hand, up to 63% of patients with R/M-EC have TP-53 gene mutations (TP53mut). And the efficacy of chemotherapy combined with immunotherapy in thse patients is controversial. In the RUBY study, TC combined with Dostarlimab reduced the risk of death in patients with TP53mut-R/M-EC by 59 percent. However, in the DUO-E study, chemotherapy combined with Durvalumab failed to improve serous -EC in 154 patients (approximately 92% TP53mut). Therefore, how to optimize the strategy of chemotherapy combined with immunotherapy in TP53mut-R/M-EC is urgently needed. Considering TP53mut-EC patients with tumor local T-lymph Cell infiltration and PD-L1 expression were significantly higher than those of TP-53 gene wild type (TP53wt) patients. It was also suggested that ICB and PARPi had a good synergistic effect. The DUO-E study revealed the combination of Durvalumab and Olaparib maintenance therapy significantly improves the prognosis of serous EC. Therefore, as an investigator-initiated open-label Phase II randomized controlled study, the study will include 117 patients with TP53mut-R/M-EC, and randomly divided 2:1 into experimental group and control group to evaluate the safety and efficacy of camrelizumab plus fluzoparib maintenance therapy in patients with recurrent or metastatic TP-53 mutated Endometrial Cancer. The study will also explore the prevalence of homologous recombination reficiency in Chinese patients with TP-53 mutated endometrial cancer and its therapeutic significance. ### Conditions Module **Conditions:** - Endometrial Carcinoma - TP53 Mutation - Recurrent or Metastatic **Keywords:** - TP53-mutated, Endometrial Carcinoma,Camrelizumab, Fluzoparib ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 117 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The treatment period mainly includes: 1. Injection of Paclitaxel (Albumin-bound) at a dose of 260mg/m\^2 administered intravenously every 3 weeks as one treatment cycle, for 6 cycles. 2. Injection of Carboplatin (AUC=5) administered intravenously every 3 weeks as one treatment cycle, for 6 cycles. 3. Injection of Camrelizumab at a dose of 200mg administered intravenously every 3 weeks as one treatment cycle, for 6 cycles. 4. Radiation therapy: Not mandatory. Maintainance therapy period mainly includes: 1. Injection of Camrelizumab at a dose of 200mg administered intravenously every 3 weeks as one treatment cycle until disease progression, intolerable toxicity, death, or up to a maximum of 2 years. 2. Oral administration of Fluzoparib capsules at a dose of 150mg, once in the morning and once in the evening until disease progression, intolerable toxicity, death, or up to a maximum of 2 years. **Intervention Names:** - Drug: Fluzoparib - Drug: Camrelizumab - Drug: paclitaxel (albumin bound) - Drug: Carboplatin injection - Drug: Carboplatin - Radiation: External irradiation **Label:** Camrelizumab with Fluzoparib as maintainance therapy **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Treatment period mainly include: 1. Injection of Paclitaxel (Albumin-bound) at a dose of 260mg/m\^2 administered intravenously every 3 weeks as one treatment cycle, for a total of 6 cycles. 2. Injection of Carboplatin (AUC=5) administered intravenously every 3 weeks as one treatment cycle, for a total of 6 cycles. 3. Injection of Camrelizumab at a dose of 200mg administered intravenously every 3 weeks as one treatment cycle, for a total of 6 cycles. 4. Radiation therapy: Not mandatory. Whether to combine radiation therapy is determined by the principal investigator based on the patient's condition. Radiation therapy includes external beam radiation and brachytherapy. Maintainance therapy period mainly includes: a) Injection of Camrelizumab at a dose of 200mg administered intravenously every 3 weeks as one treatment cycle until disease progression, intolerable toxicity, death, or up to a maximum of 2 years. **Intervention Names:** - Drug: Camrelizumab - Drug: paclitaxel (albumin bound) - Drug: Carboplatin injection - Drug: Carboplatin - Radiation: External irradiation **Label:** Camrelizumab without Fluzoparib as maintainance therapy **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Camrelizumab with Fluzoparib as maintainance therapy **Description:** During the maintenance phase of treatment. Oral administration of Fluzoparib capsules at a dose of 150mg（N=78 participants）, once in the morning and once in the evening until disease progression, intolerable toxicity, death, or up to a maximum of 2 years. **Name:** Fluzoparib **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Camrelizumab with Fluzoparib as maintainance therapy - Camrelizumab without Fluzoparib as maintainance therapy **Description:** During the maintenance phase of treatment. Camrelizumab, 200 mg administered intravenously every 3 weeks until disease progression, intolerable toxicity, death, or up to 2 years. **Name:** Camrelizumab **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Camrelizumab with Fluzoparib as maintainance therapy - Camrelizumab without Fluzoparib as maintainance therapy **Description:** Paclitaxel (albumin-bound) for injection, 260 mg/m\^2 administered intravenously in 3-week cycles for 6 cycles. **Name:** paclitaxel (albumin bound) **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Camrelizumab with Fluzoparib as maintainance therapy - Camrelizumab without Fluzoparib as maintainance therapy **Description:** AUC=5 Intravenous dosing is administered every 3 weeks for a total of 6 treatment cycles. Specific dosing cycles may be determined by the investigator **Name:** Carboplatin injection **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - Camrelizumab with Fluzoparib as maintainance therapy - Camrelizumab without Fluzoparib as maintainance therapy **Description:** AUC=5 Intravenous dosing is administered every 3 weeks for a total of 6 treatment cycles. Specific dosing cycles may be determined by the investigator **Name:** Carboplatin **Type:** DRUG #### Intervention 6 **Arm Group Labels:** - Camrelizumab with Fluzoparib as maintainance therapy - Camrelizumab without Fluzoparib as maintainance therapy **Description:** Non-essential, decision to combine is made by the principal investigator based on the patient's condition. **Name:** External irradiation **Type:** RADIATION ### Outcomes Module #### Other Outcomes **Description:** PFS in patients with different (Homologous Recombination Deficiency)HRD status and (Homologous Recombination Repair)HRR mutations **Measure:** Effect of HRD status and HRR-mutated on PFS **Time Frame:** 12 months #### Primary Outcomes **Description:** The time between randomization and tumor progression or death **Measure:** Investigator-assessed progression-free survival (PFS) **Time Frame:** 12 months #### Secondary Outcomes **Description:** The duration of remission or complete disappearance of the patient's disease after treatment **Measure:** Duration of Response（DoR） **Time Frame:** 12 months **Description:** The time between randomization and death. **Measure:** Overall Survival(OS) **Time Frame:** 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥18 * Eastern Cooperative Oncology Group (ECOG) Performance Status (ECOG): 0-2. Expected survival ≥ 6 months. * Patients with newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) 2009 stage III-IV endometrial cancer or recurrent endometrial cancer after ≤ 1 line of platinum-based chemotherapy (including neoadjuvant, adjuvant, and concurrent chemotherapy). For patients who have failed platinum-based chemotherapy, a platinum-free interval of ≥ 12 months is required. * No restriction on pathological type, abnormal p53 expression indicated by immunohistochemistry, and confirmation of TP53 gene mutation by Sanger sequencing or next-generation sequencing (NGS). * No prior treatment with immune checkpoint blockade (ICB) or poly (ADP-ribose) polymerase inhibitor (PARPi). * Discontinuation of previous radiation therapy, chemotherapy, or hormone therapy for at least 4 weeks. * Adequate organ function as follows (no use of drugs containing blood components or corrective treatment with hematopoietic growth factors in the 7 days prior to randomization): Aspartate Aminotransferase (AST) and Alanine Transaminase (ALT) ≤ 2.5 times the upper limit of normal (≤ 5 times for patients with liver metastasis) and total bilirubin ≤ 1.5 times the upper limit of normal; serum creatinine ≤ 1.5 times the upper limit of normal; platelets ≥ 90,000 cells/mm3, hemoglobin ≥ 90 g/L, and neutrophils ≥ 1,500/mm3. * Thyroid function prior to randomization: Thyroid-stimulating hormone (TSH) level ≤ 1 times the upper limit of normal, or if TSH is not within the normal range, free T4 ≤ 1 times the upper limit of normal. * Peripheral neuropathy grade \< 2 (Common Terminology Criteria for Adverse Events, CTCAE 5.0) before treatment. * Signed informed consent and ability to provide tumor tissue samples from initial diagnosis/recurrence for homologous recombination deficiency (HRD) testing. * Willingness to comply with clinic visits and follow-up. Exclusion Criteria: * Currently participating in another clinical trial or within 4 weeks since completing another clinical trial. * Known allergy to any components of the investigational drug. * Previous treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies. * Patients requiring the use of immunosuppressive medications. * Previous treatment with poly (ADP-ribose) polymerase inhibitors (PARPi). * Patients requiring systemic or absorbable topical corticosteroids at an immunosuppressive dose, or patients who have used prednisone or equivalent drugs at a dose \>10 mg/day in the two weeks prior to taking the study drug. * Patients with any active autoimmune disease or a history of autoimmune diseases, including but not limited to active hepatitis, pneumonia, uveitis, colitis (inflammatory bowel disease), pituitary inflammation, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, excluding resolved childhood asthma/atopic diseases and vitiligo. Patients with intermittent use of bronchodilators or other medical interventions for asthma should also be excluded. * Patients in the active infectious phase requiring antimicrobial treatment (e.g., antibiotics, antiviral drugs, antifungal drugs). * History of immunodeficiency, including human immunodeficiency virus (HIV) seropositivity or other acquired or congenital immunodeficiency diseases. * Uncontrolled clinically significant cardiac symptoms or diseases within the past year, including but not limited to New York Heart Association (NYHA) class II or higher heart failure, unstable angina, myocardial infarction within the past year, atrial fibrillation, clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, PR interval \>250 ms, or QTc ≥470 ms. * Arterial or venous thrombosis within the past 6 months. * Poorly controlled hypertension (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg) despite antihypertensive medication, proteinuria ≥(++) and 24-hour total urinary protein \>1.0 g. * Coagulation abnormalities (international normalized ratio \[INR\] \>2.0, prothrombin time \[PT\] \>16s), bleeding tendency, or receiving thrombolytic or anticoagulant therapy. * Patients with other malignant tumors within the past 5 years, excluding basal cell carcinoma of the skin and squamous cell carcinoma of the skin. * Vaccination with live vaccines within 4 weeks prior to the first administration of the investigational drug. Note: Administration of inactivated seasonal influenza vaccines is allowed. * History of substance abuse with psychotropic drugs and unable to quit, or patients with psychiatric disorders. * The investigator believes that any other medical, psychiatric, or social factors may affect the rights, safety, ability to sign informed consent, patient's completion of the study, or interpretation of study results. **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jiashuangzheng@cicams.ac.cn **Name:** Shuangzheng Jia, Ph D **Phone:** 00-86-010-87788276 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Name:** SHUANGZHENG JIA - **Role:** CONTACT **Country:** China **Facility:** Cancer Hospital, Chinese Academy of Medical Sciences **State:** Beijing **Status:** RECRUITING **Zip:** 100021 #### Overall Officials **Official 1:** **Affiliation:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences **Name:** GUANGWEN YUAN, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009369 - Term: Neoplasms - ID: D000014594 - Term: Uterine Neoplasms - ID: D000005833 - Term: Genital Neoplasms, Female - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000014591 - Term: Uterine Diseases - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000091662 - Term: Genital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M19235 - Name: Endometrial Neoplasms - Relevance: HIGH - As Found: Endometrial Carcinoma - ID: M17342 - Name: Uterine Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8945 - Name: Genital Neoplasms, Female - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17339 - Name: Uterine Diseases - Relevance: LOW - As Found: Unknown - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016889 - Term: Endometrial 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: D000067856 - Term: Poly(ADP-ribose) Polymerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M19537 - Name: Paclitaxel - Relevance: HIGH - As Found: Surgery - ID: M18650 - Name: Carboplatin - Relevance: HIGH - As Found: System - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M242260 - Name: Fluzoparib - Relevance: HIGH - As Found: Released - ID: M26197 - Name: Tubulin Modulators - Relevance: LOW - As Found: Unknown - ID: M26196 - Name: Antimitotic Agents - Relevance: LOW - As Found: Unknown - ID: M205 - Name: Poly(ADP-ribose) Polymerase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000017239 - Term: Paclitaxel - ID: D000016190 - Term: Carboplatin - ID: C000722917 - Term: Fluzoparib ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413979 **Acronym:** Fam-AID **Brief Title:** Family Support Protocol for Adolescent Internalizing Disorders **Official Title:** Testing the Feasibility of a Family-based Adjunctive Treatment Protocol for Targeting Co-Occurring Internalizing Disorders Among Adolescents With SUD #### Organization Study ID Info **ID:** 1R34DA056026 **Link:** https://reporter.nih.gov/quickSearch/1R34DA056026 **Type:** NIH #### Organization **Class:** OTHER **Full Name:** The National Center on Addiction and Substance Abuse at Columbia University ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2025-04-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-02 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The National Center on Addiction and Substance Abuse at Columbia University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This R34 will develop and test an adjunctive treatment protocol for addressing co-occurring internalizing disorders among adolescents enrolled in usual care for substance use problems. Internalizing disorders (ID), primarily depression and anxiety, are highly prevalent among youth receiving community-based treatment for substance use disorder (SUD). Comorbidity rates range from 30-70% due to the multiple developmental pathways by which adolescent SUD and ID cause and exacerbate one another. Moreover, unresolved ID issues significantly interfere with youth SUD treatment and recovery processes. Yet, the youth SUD clinical workforce is not systematically educated or trained in evidence-based practices for ID; thus, line services for youth SUD do not systematically target ID. The research literature offers a few integrated behavioral models for simultaneously treating both SUD and ID in youth; however, such models feature intensive manualized procedures that have proven cumbersome to scale and deliver in frontline settings. As a result, the clinical workforce, though desiring ID-focused training, currently has inadequate resources for treating ID effectively. A promising solution to diminish this quality gap is developing an adjunctive, modular protocol to augment routine care for comorbid SUD/ID by directly targeting ID as a key treatment goal: Family Support Protocol for Adolescent Internalizing Disorders (Fam-AID). As an adjunctive protocol, Fam-AID will not require clinicians to markedly alter existing base practices for SUD. It will be anchored by three evidence-based foundations for treating co-occurring adolescent ID. First, it prioritizes family engagement in services and family-oriented treatment goals, which have been shown to enhance outcomes for youth SUD and ID alike. Second, it is a modular protocol that features core elements of manualized treatment for ID; core element interventions enhance treatment effectiveness by fostering implementation feasibility and sustainability in usual care. Third, it seeks to reinforce the family safety net to prevent teen self-harm. In accord with these foundations, and pending pilot development, we anticipate that Fam-AID will contain five treatment modules that can be delivered in any sequence to meet client needs: (1) Family Engagement of caregivers and primary supports in treatment planning and services; (2) Relational Reframing of family constraints, resiliencies, and social capital connected to the youth's ID symptoms; (3) Functional Analysis of the youth's ID symptoms and related behaviors; (4) Cognitive-behavioral therapy (CBT) core techniques to address the youth's ID symptoms and functional needs, featuring three transdiagnostic interventions (emotion acceptance, emotional exposure, behavioral activation) to address negative affect and emotional dysregulation underlying both depression and anxiety; and (5) Family Psychoeducation and Safety Planning focused on education about comorbid SUD/ID and prevention of youth self-harm. All interventions featured in each module have strong empirical support. The Fam-AID protocol will contain several innovations intended to boost treatment feasibility and impact for this vulnerable group. Aligned with the core elements strategy, it will be designed for uptake by all motivated clinicians regardless of their clinical orientation and training. It will use evidence-based family engagement techniques to systematically integrate caregivers in the treatment process; typically, families are not centralized in SUD services for youth despite compelling empirical and clinical rationale to do so. It will feature a treatment customization exercise in which clients and therapists collaboratively select CBT techniques to integrate in ongoing treatment based on functional ID assessment. To achieve study aims we will first develop a Fam-AID implementation toolkit during a three-part Pilot Phase at one pilot site: (a) Solicit provider input on Fam-AID components; (b) Create video-based training and fidelity procedures, leveraging the PI's existing online therapist training and consultation resources in core CBT techniques for adolescent SUD, as well as the Co-I's equivalent training resources for adolescent ID; (c) Pilot the toolkit with 4-6 clients. In Years 2-3 we will conduct an Interrupted Time Series Study for N = 60 SUD/ID cases across two sites serving diverse youth: 30 will receive TAU, and then following line staff training, 30 new cases will receive TAU enhanced by adjunctive Fam-AID. Aim 1: Feasibility will examine Fam-AID cases for acceptability via client and therapist interviews and fidelity benchmarks via therapist- and observer-report of module coverage and protocol dose. Aim 2: Outcomes will test TAU vs. TAU + Fam-AID for immediate impact on family member attendance and ultimate impacts on adolescent ID symptoms at 3- and 6-month follow-up. ### Conditions Module **Conditions:** - Internalizing Disorders - Substance Use Disorders ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Interrupted Time Series Study ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: Family Support Protocol for Adolescent Internalizing Disorders (Fam-AID) **Label:** Fam-Aid **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Fam-Aid **Description:** (1) Family Engagement of caregivers and primary supports in treatment planning and services; (2) Relational Reframing of family constraints, resiliencies, and social capital connected to the youth's ID symptoms; (3) Functional Analysis of the youth's ID symptoms and related behaviors; (4) Cognitive-behavioral therapy (CBT) core techniques to address the youth's ID symptoms and functional needs, featuring three transdiagnostic interventions (emotion acceptance, emotional exposure, behavioral activation) to address negative affect and emotional dysregulation underlying both depression and anxiety; and (5) Family Psychoeducation and Safety Planning focused on education about comorbid SUD/ID and prevention of youth self-harm. All interventions featured in each module have strong empirical support. **Name:** Family Support Protocol for Adolescent Internalizing Disorders (Fam-AID) **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Therapist and observer report on dose of treatment delivered using Fam-AID Fidelity Checklist. The checklist will measure extensiveness of treatment technique use on a 3-point scale from 0 = not at all to 2 = quite a bit/extensively. The checklist will be developed during the study pilot phase. **Measure:** Treatment Fidelity **Time Frame:** Baseline to 6 months follow-up **Description:** Family member session attendance in terms of number of sessions attended. **Measure:** Family Involvement **Time Frame:** Baseline to 6 months follow-up **Description:** Adolescent and caregiver report on Revised Children's Anxiety and Depression Scale (RCADS). RCADS is a 47-item measure of youth's anxiety and depressive symptoms rated on a 4-point scale from 0 = Never to 3 = Always (range = 0 to 141). Higher numbers represent greater anxiety and depression. **Measure:** Internalizing disorder symptoms **Time Frame:** Baseline to 6 months follow-up **Description:** Adolescent and caregiver report on Difficulties in Emotion Regulation Scale (DERS). DERS is a 16-item scale assessing difficulties with emotion regulation on a 5-point scale from 1 = almost never to 5 = almost always (range - . Higher numbers indicate greater difficulties regulating emotions. **Measure:** Emotion Regulation **Time Frame:** Baseline to 6 months follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Youth is age 13-18. * Youth lives with a primary caregiver who can attend treatment sessions. * Youth endorses one or more DSM-5-TR symptoms for SUD and meets American Society of Addiction Medicine criteria for outpatient SU treatment. * Youth meets DSM-5-TR criteria, or has elevated symptoms and impairment, for any of the following IDs: Current or Recurrent Major Depressive Episode, Pervasive Depressive Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder, Panic Disorder, Posttraumatic Stress Disorder. * Youth completes intake and is enrolled as an active case at study site Exclusion Criteria: * Illness requiring hospitalization * Current psychotic symptoms * Severe SU problems that require immediate relief (detox or residential placement) * Pervasive developmental disorder. **Maximum Age:** 18 Years **Minimum Age:** 13 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** nporter@toendaddiction.org **Name:** Nicole P Porter, PhD **Phone:** (212) 841-5211 **Phone Ext:** 9566 **Role:** CONTACT **Contact 2:** **Email:** ahogue@toendaddiction.org **Name:** Aaron Hogue, PhD **Phone:** 212 841-5200 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000064419 - Term: Chemically-Induced Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC25 - Name: Substance Related Disorders - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M21837 - Name: Substance-Related Disorders - Relevance: HIGH - As Found: Substance Use Disorders - ID: M30302 - Name: Chemically-Induced Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000019966 - Term: Substance-Related Disorders ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413966 **Brief Title:** Study Compares Pneumothorax Recurrence: Absorbable Mesh vs. Pleurectomy in Primary Spontaneous Pneumothorax. **Official Title:** Comparison on Recurrence Rate of Pneumothorax Between Mesh and Apical Pleurectomy After Video-Assisted Thoracoscopic Blebectomy/Bullectomy for Primary Spontaneous Pneumothorax: A Randomized Controlled Trial (Pilot Study) #### Organization Study ID Info **ID:** SUR-2566-0393 #### Organization **Class:** OTHER **Full Name:** Chiang Mai University ### Status Module #### Completion Date **Date:** 2026-03-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-03-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-03-21 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Chiang Mai University #### Responsible Party **Investigator Affiliation:** Chiang Mai University **Investigator Full Name:** Apichat Tantraworasin **Investigator Title:** Associate Professor Doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a prospective, randomized controlled trial (pilot study) that aims to determine the incidence of post-operative recurrent pneumothorax within one-year timeframe after video-assisted thoracoscopic blebectomy/bullectomy with either apical pleurectomy or partially absorbable mesh, as well as to assess the efficacy in preventing post-operative recurrence pneumothorax. Patients, aged more than or equal 20-year-old, with the diagnosis of primary spontaneous pneumothorax, who require video-assisted thoracoscopic surgery at Maharaj Nakorn Chiangmai Hospital, Chiang Mai University, Chiang Mai, Thailand, will be enrolled into this study. The inform consent will be obtained before the enrollment. Patients will be randomized to two groups; Partially absorbable mesh coverage group (intervention group) and Apical pleurectomy group (control group). **Detailed Description:** Background/Literature Review: Primary spontaneous pneumothorax (PSP) is one of the most common respiratory conditions that usually occurs in young patients. While not a serious illness, it is worrisome because of its high rate of recurrence, ranging from 17 to 54%. Initial management for PSP is pleural drainage by aspiration of chest tube thoracostomy. Surgical intervention is needed if there was persistent air leakage (more than or equal to 5 days) after chest tube insertion or recurrent pneumothorax. According to the British Thoracic Surgery (BTS) guideline for spontaneous pneumothorax, both open thoracotomy and video-assisted thoracotomy to blebectomy with apical pleurectomy is comparable in treating difficult or recurrent pneumothorax and considered a mainstay of treatment. Video-assisted thoracoscopic surgery (VAT) is a preferred surgical method for treating recurrence PSP because of its minimal invasiveness and low morbidity, which includes shorter length of hospital stays, less post-operative pain and post-operative pulmonary dysfunction. However, the frequency of post-operative recurrent pneumothorax following VAT procedure is higher than that of a conventional open thoracotomy, with reports of less than 1 percent. This frequency for that of VAT ranges from 9.5 percent to 24.5 percent. Therefore, when employing a less invasive approach, this needs to be balanced against the slight increase in recurrence rate. The possible risk factors for recurrent pneumothorax after VAT include staple line leakage, overlooked or concealed blebs, bullae degeneration, incomplete resection of blebs, emphysematous changes in the resected area and visceral pleura damage during procedures6. To minimize postoperative recurrence, other preventive measures were introduced in addition to apical pleurectomy, such as chemical8,9 and mechanical pleurodesis, fibrin glue, mesh covering, or a combination of these measures (e.g., fibrin glue with mesh coverage). However, aside from apical pleurectomy, which have been mentioned in the BTS guideline, there is currently no other conclusive additional procedure that has been considered as part of standard treatment, necessitating further research. Chemical pleurodesis yields an excellent rate of success in minimizing postoperative recurrent pneumothorax. It is simple and considered a cost-effective method. However, complete pleural symphysis can impair a patient's pulmonary function and sometimes produce chronic chest pain. Pleurectomy also increases the risk of postoperative bleeding, resulting in a longer period of chest tube insertion and fibrothorax, which could be challenging for future thoracic surgery. Apical pleurectomy is one of the most widely used procedures because of its safety and feasibility. It results in adhesion between the visceral and parietal pleura, preventing the recurrence of postoperative pneumothorax. According to systemic review, mechanical apical pleurectomy exhibits comparable results in terms of 1-year postoperative recurrence pneumothorax as apical pleurectomy after thoracoscopic stapled blebectomy/bullectomy (p-value of 0.821). However, it produces less residual chest pain and a lower rate of hemothorax than apical pleurectomy. Mesh coverage is increasing in popularity due to its reduction in postoperative recurrent pneumothorax, postoperative bleeding, and postoperative pain16, comparing to other additive procedure, including apical pleurectomy. Despite of the fact that both apical pleurectomy and mesh coverage have a comparable result in preventing post-operative recurrent pneumothorax, patients who underwent mechanical apical pleurectomy experienced with more severe residual pain than those with mesh coverage. Previous study found that the use of absorbable mesh for staple line coverage after blebectomy/bullectomy can significantly decrease postoperative pneumothorax with a recurrence rate of 2.6%, compared with 9.5% in patients who received VATS after blebectomy/bullectomy alone. The previous studies also display similar surgical outcomes. Additional mechanical pleurodesis after covering the staple line with absorbable cellulose mesh and fibrin glue can also significantly lower the recurrent rate of postoperative pneumothorax, with a recurrence rate of 4.0%. The postoperative 1-year recurrence rate was 9.5% in the absorbable mesh with fibrin glue group and 10.7% in the mechanical pleurodesis group. As demonstrated in the preceding paragraphs, mesh coverage, with or without additional techniques such as fibrin glue, has been utilized in numerous prospective and retrospective studies to reinforce visceral pleura and symphyseal effects in order to prevent post-operative recurrent pneumothorax. However, due to its limited application in Thai clinical practice, information regarding the effectiveness of this surgical technique in preventing post-operative recurrent pneumothorax is scarce. Therefore, our goal is to conduct a prospective randomized controlled trial (pilot study) to determine whether the use of mesh as an additional procedure is more effective than the conventional technique, which is apical pleurectomy, in terms of preventing post-operative recurrent pneumothorax in patients with PSP who underwent video-assisted thoracoscopic blebectomy/bullectomy. Rationale: In standard of care for patients diagnosed with PSP who met the criteria for surgical treatment at Maharaj Nakorn Chiangmai Hospital, blebectomy or bullectomy with apical pleurectomy under video-assisted thoracoscopic approach will be performed. The utilization of mesh coverage as a preventive measure remains uncommon in Maharaj Nakorn Chiangmai Hospital, as well as in the majority of hospitals throughout Thailand. This stands in contrast to Japan, Korea, or Taiwan, where the use of mesh coverage to prevent post-operative pneumothorax has produced favorable results. As a result, compared to the standard of care, which is apical pleurectomy, there are still not many studies done in Thailand to assess the efficacy of mesh in preventing postoperative pneumothorax. Therefore, the researcher is motivated to carry out this study in order to assess the efficacy of mesh. As of yet, the mesh remains incapable of distributing funds in accordance with the patient's healthcare coverage. As a result, funding requests are required to carry out this research investigation. Should the results prove to be significant, it could subsequently be implemented as an alternative or even become a standard treatment for patients with PSP who were surgical candidates at Maharaj Nakorn Chiangmai hospital. Furthermore, funds for this treatment, which includes the cost of the mesh, could possibly be deducted from the patients' healthcare coverage. Objectives: * Determine the incidence of post-operative recurrent pneumothorax within one-year timeframe after video-assisted thoracoscopic blebectomy/bullectomy with either apical pleurectomy or partially absorbable mesh. * Assess the efficacy in preventing post-operative recurrence pneumothorax after video-assisted thoracoscopic blebectomy/bullectomy with either apical pleurectomy or partially absorbable mesh. * To compare the peri-operative and post-operative outcomes, as well as post-operative complications, of these two surgical techniques. ### Conditions Module **Conditions:** - Primary Spontaneous Pneumothorax **Keywords:** - Primary Spontaneous Pneumothorax - Video-assisted Thoracoscopic Surgery - Apical pleurectomy - Partially absorbable mesh coverage - Recurrence rate of pneumothorax ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Masking Description:** * Participants (Double-blinded) and Assessor (nurse who will be assigned for collecting perioperative and postoperative results after surgery) * After obtaining informed consent and the patient's agreement to participate in the study, the patients will be allocated block sizes of four and computer-generated random numbers in sequential order within opaque envelopes that are sealed. The allocation process follows a 1:1 ratio. * Those sealed envelopes were kept by the researcher. On the day of operation, after video-assisted thoracoscopic blebectomy/bullectomy will be done, a randomized envelope will be opened by the scrub nurse to determine which additional method would be used between partially absorbable mesh and apical pleurectomy. **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 24 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** - This group of patient will receive partially absorbable mesh coverage (ULTRAPRO size 15 x 15 cm, Ethicon) as an additional procedure after VATs to blebectomy/bullectomy. **Intervention Names:** - Procedure: Partially absorbable mesh **Label:** Partially absorbable mesh coverage group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** - This group of patient will receive standard surgical treatment that is used at Maharaj Nakorn Chiangmai Hospital, which is blebectomy or bullectomy with apical pleurectomy under video-assisted thoracoscopic approach **Intervention Names:** - Procedure: Apical pleurectomy **Label:** Apical pleurectomy group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Partially absorbable mesh coverage group **Description:** - In this group, after bullectomy or blebectomy, partially absorbable mesh (ULTRAPRO size 15 x 15 cm, Ethicon) will be prepared and inserted into the pleural cavity through one of the working ports and placed at the apical part of the thoracic cage (over the staple line) using fixation device (ProTack™ 5 mm fixation device, Medtronic). **Name:** Partially absorbable mesh **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Apical pleurectomy group **Description:** - In apical pleurectomy group, after bullectomy or blebectomy, the parietal surface from the apex to the fifth rib was dissected and abraded using a curved dissector with a diathermy scratch pad. Abrasion was done until a uniform aspect of bloody pleura was obtained. **Name:** Apical pleurectomy **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Recurrence rate of ipsilateral pneumothorax at least one- year follow-up period and up to 24 months after video-assisted thoracoscopic bullectomy with either partially absorbable mesh or apical pleurectomy. Gold standard for detecting recurrent pneumothorax is chest radiography and it is defined as the presence of an ipsilateral pneumothorax of any size in the follow-up chest radiography. **Measure:** Recurrence rate of pneumothorax after operation **Time Frame:** From date of surgery until the date of last follow-up, assessed at least 12 months and up to 24 months #### Secondary Outcomes **Description:** Time between skin incision to surgical wound closure, report in minutes **Measure:** Operative time (minute) **Time Frame:** From time of skin incision until time of skin closure during intraoperative period **Description:** Duration of chest tube insertion **Measure:** Postoperative chest tube duration (days) **Time Frame:** From date of first postoperative day until the date of chest drain removal, assessed up to 30 days **Description:** Using Visual analog scale (scale range from 0-10) **Measure:** Postoperative pain (pain score) **Time Frame:** From time of immediate postoperative period until time of the patient has been discharged or date of death from any cause, whichever came first, assessed up to 30 days **Description:** composite postoperative complications include persistent air leaks (more than or equal to 5 days) after operation, Fever, Empyema, and Pneumonia **Measure:** Composite postoperative complications **Time Frame:** From time of immediate postoperative until time of the patient has been discharged or date of death from any cause, whichever came first, assessed up to 30 days. **Description:** Cost during hospitalization **Measure:** Hospitalization cost (baht) **Time Frame:** From the date that patient has been admitted until the date that patient has been discharged or date of death from any cause during admitted, assessed up to 30 days **Description:** The amount of pleural fluid per day until it has been removed. **Measure:** Postoperative pleural effusion (ml) **Time Frame:** From date of 1st postoperative day until date of chest drain removed, assessed up to 30 days **Description:** Blood loss collected by anesthesiologist or surgeon **Measure:** Intraoperative blood loss (ml) **Time Frame:** From time of skin incision until time of skin closure during operative period **Description:** The dosage of morphine using will be counted from immediate postoperative period till discharged. **Measure:** Dosage of morphine use after postoperative period till discharged. **Time Frame:** From time of immediate postoperative period until time of patient discharged from hospital, assessed up to 30 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients (both sex) with first or second episode of primary spontaneous pneumothorax (either ipsilateral or contralateral) who have meet at least one of the following criteria for surgery below. * Persistent air leakage five days following the insertion of a chest tube to treat spontaneous pneumothorax3,26 or failure of lung re-expansion2 * Air leakage after surgery will be categorized into 4 grades based on Robert David Cerfolio Classification System27; Grade1 inspire and expire air leakage (continuous air leakage), Grade 2 inspire air leakage, Grade 3 expire air leakage and Grade 4 forced expire air leakage. * No matter grade of air leakage, once patients have any grade of air leakage of 4-5 days after chest drain insertion, they will be diagnosed with persistent air leakage. * Hemopneumothorax * Bilateral pneumothorax * Visible blebs on the initial plain chest film or computed tomography * Professions at risk (Aircraft personals, divers) * Aged more than or equal to 20 years old. Exclusion Criteria: * Hemothorax or Pneumothorax that requires bilateral thoracic surgery. * Previous ipsilateral thoracic operation * Other serious concomitant illnesses or medical conditions e.g., Congestive heart failure, unstable angina, history of myocardial infarction within 1 year prior to entering this study. * History of significant neurologic or psychiatric disorder **Maximum Age:** 70 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ohm_med@hotmail.com **Name:** Apichat Tantraworasin, M.D, Ph.D. **Phone:** +6653945767 **Role:** CONTACT **Contact 2:** **Email:** tengearneae@gmail.com **Name:** Somcharoen Saeteng, M.D. **Phone:** +6653945767 **Role:** CONTACT #### Locations **Location 1:** **City:** Chiang Mai **Contacts:** ***Contact 1:*** - **Email:** ohm_med@hotmail.com - **Name:** Apichat Tantraworasin, M.D., Ph.D. - **Phone:** +66896336342 - **Phone Ext:** +66896336342 - **Role:** CONTACT ***Contact 2:*** - **Name:** Apichat Tantraworasin, M.D., Ph.D. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Thailand **Facility:** Department of surgery, Faculty of medicine, Chiang Mai University Hospital **State:** Chaing Mai **Status:** RECRUITING **Zip:** 50200 #### Overall Officials **Official 1:** **Affiliation:** Chiang Mai University **Name:** Apichat Tantraworasin, M.D, Ph.D. **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000010995 - Term: Pleural 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: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14850 - Name: Recurrence - Relevance: HIGH - As Found: Recurrence - ID: M13920 - Name: Pneumothorax - Relevance: HIGH - As Found: Pneumothorax - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M13885 - Name: Pleural Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: T4713 - Name: Primary Spontaneous Pneumothorax - Relevance: HIGH - As Found: Primary Spontaneous Pneumothorax ### Condition Browse Module - Meshes - ID: D000011030 - Term: Pneumothorax - ID: D000012008 - Term: Recurrence ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413953 **Brief Title:** A Clinical Study of TQB3107 Tablets in Patients With Malignant Tumors **Official Title:** A Phase I Clinical Study of Tolerability and Pharmacokinetics of TQB3107 Tablets in Patients With Malignant Tumors #### Organization Study ID Info **ID:** TQB3107-I-01 #### Organization **Class:** INDUSTRY **Full Name:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ### Status Module #### Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2023-12 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** TQB3107 is a protein inhibitor that induces apoptosis and inhibits the proliferation of various tumor cells. This clinical study aims to evaluate the safety and tolerability of TQB3107 tablets in subjects with advanced malignancies, to determine the dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) (if any), and the recommended dose for Phase II (RP2D). ### Conditions Module **Conditions:** - Advanced Cancers ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 140 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Dosing regimen 1 (20/28): 28 days per cycle (4 weeks), the medication is administered once daily for 5 consecutive days per week, followed by a 2-day break. The initial dose is a single fasting dose of C0, with a subsequent 7-day observation period. Dosing regimen 2 (28/28): 28 days per cycle, the medication is administered once daily for the entire 28-day period, all other dosing requirements are consistent with Regimen 1. **Intervention Names:** - Drug: TQB3107 Tablets **Label:** TQB3107 tablets **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - TQB3107 tablets **Description:** TQB3107 tablets is protein inhibitor that inhibit tumor cell proliferation, and induce apoptosis, thereby exerting anti-tumor effects. **Name:** TQB3107 Tablets **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** DLT refers to toxicities that are associated with the drug and occur from the first medication administration to the end of the first treatment cycle, as defined by the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 toxicity assessment criteria. **Measure:** Dose Limiting Toxicity (DLT) **Time Frame:** At the end of Cycle 1 (each cycle is 28 days) **Description:** MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients. **Measure:** Maximum tolerated dose (MTD) **Time Frame:** At the end of Cycle 1 (each cycle is 28 days) **Description:** The recommended dose, determined after initial dose escalation and toxicity assessment, it is used to further evaluate the efficacy and safety of the drug. **Measure:** Phase II Recommended Dose (RP2D) **Time Frame:** Baseline up to 24 months #### Secondary Outcomes **Description:** The time it takes for the concentration of the drug in the plasma to be reduced by 50%. **Measure:** Elimination half-life (t1/2) **Time Frame:** Day 1 of cycles 0 and 2: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; Days 1, 8 and 15 of cycle 1: in 30 minutes (pre-dose); Day 26 of cycle 1: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose **Description:** The time it takes to reach peak concentrations after administration. **Measure:** Time to Peak (Tmax) **Time Frame:** Day 1 of cycles 0 and 2: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose；Days 1, 8 and 15 of cycle 1: in 30 minutes (pre-dose); Day 26 of cycle 1: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose **Description:** Maximum plasma concentration of drug. **Measure:** Peak Concentration (Cmax) **Time Frame:** Day 1 of cycles 0 and 2: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; Days 1, 8 and 15 of cycle 1: in 30 minutes (pre-dose); Day 26 of cycle 1: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose **Description:** The area enclosed by the plasma concentration curve against the timeline. **Measure:** Area under the plasma concentration-time curve (AUC0-last) **Time Frame:** Day 1 of cycles 0 and 2: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; Days 1, 8 15 of cycle 1: in 30 minutes (pre-dose); Day 26 of cycle 1: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose **Description:** The highest plasma drug concentration that occurs after stabilization. **Measure:** Steady-state peak concentration (Css-max) **Time Frame:** Day 1 of cycle 0 and 2: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; Days 1, 8 and 15 of cycle 1: in 30 minutes (pre-dose); Day 26 of cycle 1: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose **Description:** Minimum plasma drug concentration during dosing. **Measure:** Steady-state trough concentration (Css-min) **Time Frame:** Day 1 of cycles 0 and 2: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; Days 1, 8 and 15 of cycle 1: in 30 minutes (pre-dose); Day 26 of cycle 1: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose **Description:** The percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. **Measure:** Objective Response Rate (ORR) **Time Frame:** Up to 2 years **Description:** Proportion of patients whose tumors achieve remission (PR+CR) and stable disease (SD) after treatment and can maintain the minimum timeframe required according to accepted response evaluation criteria (e.g., RECIST version 1.1 for solid tumors). **Measure:** Disease Control Rate (DCR) **Time Frame:** Up to 2 years **Description:** The time from first documented response to documented disease progression. **Measure:** Duration of Response (DOR) **Time Frame:** Up to 2 years **Description:** The time from the start of treatment to tumor progression or death from any cause, whichever occurs first. **Measure:** Progression-free survival (PFS) **Time Frame:** Up to 2 years **Description:** The time from the start of treatment to death from any cause. **Measure:** Overall Survival (OS) **Time Frame:** Up to 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18 years ≤ age≤ 75 years (calculated from the date of signing the informed consent); Score 0\~1 point, estimated survival ≥ 3 months； * Malignant tumors with no standard treatment regimen or disease progression or intolerance after prior standard therapy； * The major organs are functioning well； * Negative serum pregnancy test within 7 days prior to the first dose and must be a non-lactating subject, female and male subjects of childbearing potential should agree to use contraception throughout the study and for 6 months after the study ends; * Subjects voluntarily participated in this study, signing the informed consent form and demonstrating good compliance. Exclusion Criteria: * Hematologic malignancy has or is suspected to involve the central nervous system, or primary central nervous system lymphoma; * Received any anti-cancer therapy such as major surgery, chemotherapy and/or radiotherapy, immunotherapy, or targeted therapy within 4 weeks prior to the first dose; * Combined with severe or not well-controlled diseases, which the investigator judges to be at greater risk of entering this study； * Those with a history of drug addiction or substance abuse； * Based on the investigator's judgement, subjects with concomitant diseases that pose a significant risk to their safety or compromise the study's completion, or subjects deemed unsuitable for enrollment due to other reasons, will be excluded. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** lzmsysu@163.com **Name:** ZhiMing Li, Doctor **Phone:** 13719189172 **Role:** CONTACT #### Locations **Location 1:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Email:** lzmsysu@163.com - **Name:** ZhiMing Li, Doctor - **Phone:** 13719189172 - **Role:** CONTACT **Country:** China **Facility:** Sun Yat-sen University Cancer Cen **State:** Guangdong **Zip:** 510060 ## Derived Section ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413940 **Brief Title:** Exploring the Clinical Efficacy of Remote Management Applications Through Comprehensive Physical Therapy for Patients With Moderate to Severe Sleep Apnea **Official Title:** Effect of Mobile-health and Comprehensive Physical Therapy on Moderate-to-severe Obstructive Sleep Apnea Hypoventilation Syndrome #### Organization Study ID Info **ID:** 2023-ZX036 #### Organization **Class:** OTHER_GOV **Full Name:** China National Center for Cardiovascular Diseases ### Status Module #### Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-26 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** China National Center for Cardiovascular Diseases #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** To observe comprehensive physical therapy program for OSAHS patients **Detailed Description:** This study proposes to conduct a randomized controlled trial ，using an APP and wearable devices to provide comprehensive physical therapy and monitoring for people with moderate to severe OSAHS,to assess the effectiveness and adherence of different physiotherapy programs for patients with moderate-to-severe OSAHS by observing the improvement of sleep apnea hypoventilation index (AHI), nocturnal minimum oxygen saturation (Low SpO2), mean oxygen saturation (Mean SpO2), and other health outcomes in the study population. It is expected to explore a clinical treatment pathway suitable for patients with moderate-to-severe OSAHS through mobile app and comprehensive physical therapy, improve the treatment adherence of OSAHS patients, enhance the level of health management services in hospitals, and obtain more physical health and health economic benefits. ### Conditions Module **Conditions:** - OSAHS - Oropharyngeal Muscle Training - Aerobic Exercise - Comprehensive Physical Therapy - M-health **Keywords:** - OSAHS - Comprehensive physical therapy - m-health ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 105 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects in the control group will receive usual care(On-site healthy lifestyle promotion) **Label:** Control group **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Subjects in the physical therapy group will receive myofunctional therapy and inspiratory muscle training **Intervention Names:** - Behavioral: Myofunctional Therapy - Behavioral: Inspiratory Muscle Training **Label:** Physical therapy group **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Subjects in the combined exercise group will receive myofunctional therapy ,inspiratory muscle training and aerobic training **Intervention Names:** - Behavioral: Myofunctional Therapy - Behavioral: Inspiratory Muscle Training - Behavioral: Aerobic Exercise **Label:** Combined Exercise Group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Combined Exercise Group - Physical therapy group **Description:** Oropharyngeal and tongue exercises : strengthening upper airway muscle 20 minutes **Name:** Myofunctional Therapy **Other Names:** - MT **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Combined Exercise Group - Physical therapy group **Description:** Respiratory muscle strengthening:inspiratory muscle strengthening by resistive loading of 50% maximum inspiratory pressure. **Name:** Inspiratory Muscle Training **Other Names:** - IMT **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - Combined Exercise Group **Description:** Exercise intensity :40%-60% HRmax , 3-5 days/week **Name:** Aerobic Exercise **Other Names:** - AE **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** Our study observe the changes in cardiorespiratory function from baseline to 3 months.In this program, a cycling graded incremental exercise program (Ramp program) was used, peak oxygen uptake was monitored. **Measure:** Peak oxygen uptake **Time Frame:** 3 months **Description:** Changes in sleep quality from baseline to 3 months. The sleep quality was assessed by the Pittsburgh Sleep Quality Index (PSQI) .The scoring criteria are: 0-5 for very good sleep quality, 6-10 for okay sleep quality, 11-15 for average sleep quality, and 16-21 for very poor sleep quality, with higher total scores indicating poorer sleep quality; **Measure:** Sleep quality **Time Frame:** 3 months **Description:** Changes in body composition analysis from baseline to 3 months.Using bioelectrical impedance analysis to monitor body weight,weight and height will be combined to report BMI in kg/m\^2. **Measure:** Body composition **Time Frame:** 3 months **Description:** Changes in quality of life from baseline to 3 months.Quality of life was assessed using the short form 36 questionnaire (SF-36).The score is 0-100, with higher scores indicating higher quality of patient survival. **Measure:** Quality of life score **Time Frame:** 3 months #### Primary Outcomes **Description:** The home sleep apnea test (HSAT) device was used to detect the AHI of OSAHS patients, and the AHI was defined as the average number of apneas or hypoventilation per hour during sleep. According to the guidelines and related literature grouping,AHI ≥ 5 times/h was diagnosed as OSAHS, 5 times/h ≤ AHI \< 15 times/h as mild OSAHS, and AHI ≥ 15 times/h as moderate to severe OSAHS. Our study observe the changes in apnea-hypopnea index from baseline to 3 months **Measure:** apnea-hypopnea index(AHI) **Time Frame:** 3 months #### Secondary Outcomes **Description:** The home sleep apnea test (HSAT) device was used to detect the Low SpO2 of OSAHS patients. Our study observe the changes in Low SpO2 from baseline to 3 months. **Measure:** Minimum oxygen saturation at night（Low SpO2） **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Aged 18 to 60 years; 2. Those who have been recently diagnosed with moderate-to- severe OSAHS (AHI ≥ 15 beats/h) and who refuse or cannot tolerate the counter-adverse effects and refuse CPAP therapy after conventional medical advice; 3. Those who have not undergone any physical therapy; 4. Have some communication and comprehension skills and can use a smart phone; 5. Signed informed consent. Exclusion Criteria: 1. BMI \> 35kg/m2; 2. Patients with central and mixed sleep apnea; 3. Those who use sleep aids (including benzodiazepines and non-benzodiazepine sedative-hypnotics, anxiolytics with sleep-aiding effects, antidepressants, antipsychotics) and/or nutritional supplements; 4. Those suffering from acute myocardial infarction, acute tachyarrhythmia, pulmonary edema, severe aortic stenosis and other acute cardiovascular diseases; 5. Those with severe respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), lung volume limitation (due to obesity, pregnancy, or spinal deformity), or cystic fibrosis, pneumothorax, or alveoli; 6. Those with hypothyroidism; 7. Those with severe ENT disorders such as severe upper airway obstruction (complete nasal congestion, tonsil grade III/IV), tongue-tie (Marchesani's protocol), motor symptoms limiting the tongue, antecedent or presence of temporomandibular joint disorders, and severe craniofacial injuries; 8. Those with inflammation-related systemic diseases (e.g., arthritis, tuberculosis, vasculitis, lupus); 9. Those who suffer from neuromuscular diseases (e.g., Duchenne muscular dystrophy) or diseases of the skeleton that prevent them from performing parallel movements due to exercise; 10. Those who smoke and drink alcohol; 11. Those who have had other sleep apnea treatments within 6 months (e.g., surgical procedures, MAD or CPAP treatments) that may affect the study results; 12. Ongoing clinical trials of drugs or devices in which they are participating; 13. Refusal to sign the informed consent form. **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** wuyifan1127@126.com **Name:** Yifan Wu **Phone:** 010-88398069 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Fuwai Hospital **Name:** Xue Feng **Role:** PRINCIPAL_INVESTIGATOR ## 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: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M4361 - Name: Apnea - Relevance: LOW - As Found: Unknown - ID: M15694 - Name: Sleep Apnea Syndromes - Relevance: HIGH - As Found: Sleep Apnea - ID: M22010 - Name: Sleep Apnea, Obstructive - Relevance: LOW - As Found: Unknown - ID: M10090 - Name: Hypoventilation - 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 ### Condition Browse Module - Meshes - ID: D000012891 - Term: Sleep Apnea Syndromes ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413927 **Brief Title:** Novice Driver Education and Crash Reduction **Official Title:** A Contemporary Look at Driver Training and Its Role in Reducing Crash Risk in Novice Adolescent Drivers #### Organization Study ID Info **ID:** 21-019445 #### Organization **Class:** OTHER **Full Name:** Children's Hospital of Philadelphia #### Secondary ID Infos **ID:** 1R01HD108249-01A1 **Link:** https://reporter.nih.gov/quickSearch/1R01HD108249-01A1 **Type:** NIH ### Status Module #### Completion Date **Date:** 2027-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-04-24 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institutes of Health (NIH) **Class:** OTHER **Name:** University of Pennsylvania **Class:** OTHER **Name:** University of Michigan **Class:** NIH **Name:** Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) #### Lead Sponsor **Class:** OTHER **Name:** Children's Hospital of Philadelphia #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study will test the effectiveness of different types of driver training interventions for reducing young new driver crash risk early after licensure. **Detailed Description:** Motor vehicle crashes remain high in young drivers, despite graduated driver licensing laws that put restrictions on driving and delay licensure. Typically, data trends show that crash risk is highest right after licensure, in the early months of independent driving. Additional studies of different driver training interventions have shown some evidence that it is possible to improve skills and reduce crashes early in licensure for young drivers. However, Pennsylvania and many other states have no professional training requirements for young drivers. This study will test the effectiveness of different types of driver training programs for reducing young new driver crash risk early after licensure. A thousand adolescent learner drivers in Pennsylvania will be recruited through Primary Care Clinics at Children's Hospital of Philadelphia to take part in a study that will continue through the learner phase and for 6 months after licensure. Participants will give informed consent and be asked to complete some baseline surveys and cognitive tasks in-person during a clinical or other visit. All will receive care-as-usual. Participants will also be followed through the learner phase with a smartphone app that monitors driving trips and monthly surveys that can be completed at home. In the learner phase, participants will randomly receive one of three interventions. One group of participants will receive professional behind-the-wheel training with a local driving school instructor. Another group will receive a modern online driver training course. Another group will receive an online vehicle and driver safety training course. After the learner phase, participants will be given a state license examination and will be followed for 6 months after licensure, with online surveys at 2 and 6 months after licensure, and with continued driver trip monitoring through the smartphone app. ### Conditions Module **Conditions:** - Risk Reduction Behavior - Injuries - Accident, Traffic - Development, Adolescent **Keywords:** - Injury prevention - Adolescent development - Learner drivers - Crash risk reduction - Novice drivers - Risky Driving - Teens ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Masking Description:** The research staff who are unblinded will deliver the electronic surveys and cognitive battery (which is automatically scored) at baseline before participants are randomly assigned to an arm. The primary outcome variables are automatically scored, thus blindly to intervention arm. The Virtual Driving Assessment is a self-guided tool and is automatically scored. The smartphone app automatically records hard braking events and other behaviors without knowledge of intervention arm. Licensing tests will be conducted by state-sanctioned licensing examiners who will be blinded to which arm the participant is in (per state mandate). **Who Masked:** - CARE_PROVIDER - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 1200 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants in this arm will receive care as usual, and also complete an online video training module on vehicle and driver safety, with a short quiz at the end to determine compliance. The training content will not teach driving skills, as in the other online driver training arm. It requires up to two hours to complete and can be done from any internet-connected computer (at home, at school, etc.). **Intervention Names:** - Behavioral: Online Vehicle and Driver Safety Training **Label:** Control Condition: Care-as-usual **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Participants in the Online Driver Skills Training arm will complete an online driver skill training program known as Accelerated Curriculum to Create Effective Learning (ACCEL) for novice drivers. It requires up to two hours to complete and can be done from any internet-connected computer (at home, at school, etc.). **Intervention Names:** - Behavioral: Online Driver Skills Training **Label:** Online ACCEL Training **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Participants in the Behind-the-Wheel training arm will receive professional behind-the-wheel training course delivered in-person on the road by a local driving school instructor through our partnership with Driver Training Services. **Intervention Names:** - Behavioral: Behind-the-Wheel Driver Training **Label:** Behind-the-Wheel Driver Training **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Control Condition: Care-as-usual **Description:** This online video education program provides education in vehicle and driver safety (e.g. vehicle maintenance, adjusting car seats and seatbelts). This online training will take up to 2 hours to complete and will have a short quiz at the end to determine compliance with this online training. **Name:** Online Vehicle and Driver Safety Training **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Online ACCEL Training **Description:** The online driver training is the Accelerated Curriculum to Create Effective Learning (ACCEL) is designed to enhance the ability to anticipate, recognize and respond to hazards and to maintain attention to the road. The training is delivered online via a computer and can be done from home or at a school or other site that has a computer with internet access. It requires up to two hours to complete, and will be hosted on a platform that will track progress and completion through the training (such as accuracy, duration in modules, time to complete) and a short quiz will be provided at the end to assess learning. **Name:** Online Driver Skills Training **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - Behind-the-Wheel Driver Training **Description:** The professional behind-the-wheel training course will be conducted in-person, delivered by local driving school partner Driver Training Services. The curriculum consists of 6 hours of training with assigned practice between lessons, and meets Pennsylvania and national standards. Post-lesson forms completed by the instructors will record adherence and consistency (intervention fidelity). **Name:** Behind-the-Wheel Driver Training **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** For Aim 1 and 3, the primary outcome is the number of hard braking events per 100 miles driven during, as measured via the Way-to-Drive App. **Measure:** Hard Braking Events **Time Frame:** Measured over the 6 months post-licensure at the end of the study (about month 18-24). **Description:** The primary outcome in Aim 2 and 3 will be the pass rate on the first licensure exam attempt. **Measure:** Pass rate on the licensure exam **Time Frame:** Measured at the time of the license examination, post-intervention (in about month 8-18). #### Secondary Outcomes **Description:** For Aim 1 and 3: minutes of handheld phone use per hour of driving, as measured via the Way-to-Drive App. **Measure:** Phone Use While Driving **Time Frame:** Measured over the 6 months post-licensure at the end of the study (about month 18-24). **Description:** For Aim 1 and 3: Proportion of drive time \>10 miles over the posted speed limit, as measured via the Way-to-Drive App. **Measure:** Speeding **Time Frame:** Measured over the 6 months post-licensure at the end of the study (about month 18-24). **Description:** For Aim 1 and 3: Self-reported involvement in crashes as a driver (binary yes/no) as captured by a question in our follow-up driver experience questionnaire: response options are 1) none; 2) one; 3) two; 4) more than 2. This item has been used in previous studies as part of the modified Driver Behavior Questionnaire (mDBQ). **Measure:** Crash Involvement **Time Frame:** Measured at 2-, 4- and 6-month follow-up post-licensure (about month 18-24). **Description:** For Aim 1 and 3: Risky Driving factor score as captured through self-reported responses on the modified driver behavior questionnaire, in which participants rate how often they engage in 11 different risk-taking behaviors while driving on a 6-point scale from "Never" to "Nearly all the time." **Measure:** Risky driving behavior **Time Frame:** Measured at 2-, 4- and 6-month follow-up post-licensure (within about month 18-24). **Description:** For Aim 2 and 3: the class of driving behavior assessed via performance on a virtual driving assessment. **Measure:** Virtual Driving Assessment performance **Time Frame:** Measured at the time of the license examination, post-intervention (in about month 8-18). **Description:** For Aim 2 and 3: the change in virtual driving assessment performance class assessed via performance on a virtual driving assessment pre- and post-intervention. **Measure:** Change in Virtual Driving Assessment performance **Time Frame:** Measured at the time of the license examination, post-intervention (in about month 8-18). **Description:** For Aim 2 and 3: the number of attempts taken to pass the licensure exam. **Measure:** Number of license exam attempts **Time Frame:** Measured at the time of the license examination, post-intervention (in about month 8-18). ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adolescents ages 15-18 years old who reside in Pennsylvania * Scheduled to or recently attended Primary Care visit with participating virtual driving assessment (VDA) * Subject must receive/will be receiving Pennsylvania medical certification for a Pennsylvania learner permit * Subject must Intend to get a Pennsylvania learner permit (first time applicants only) within 4 weeks * Have a personal cell phone and access to a smartphone/tablet/computer with Internet access * Are able to read/write in English * Provide informed consent/assent Exclusion Criteria: * Possession of permit or license prior to enrollment at any time * Non-Pennsylvania resident * Participants who do not pass the license exam will not be able to complete the post-license monitoring until the license is obtained **Healthy Volunteers:** True **Maximum Age:** 18 Years **Minimum Age:** 15 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** walshee@chop.edu **Name:** Elizabeth A Walshe, PhD **Phone:** 267-425-1583 **Role:** CONTACT **Contact 2:** **Email:** millnerj@chop.edu **Name:** Jamillah T Millner, MPH **Phone:** 267-425-0375 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Children's Hospital of Philadelphia **Name:** Elizabeth A Walshe, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Children's Hospital of Philadelphia **Name:** Flaura Winston, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** Children's Hospital of Philadelphia/University of Pennsylvania **Name:** Dan Romer, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M4854 - Name: Benzocaine - Relevance: LOW - As Found: Unknown - ID: T433 - Name: Tannic Acid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413914 **Brief Title:** Evaluation of Cognitive Behavioral Therapy for Long-term Pain in Rheumatic Disease, Including Validation of AE-FS **Official Title:** Evaluation of Cognitive Behavioral Therapy for Long-term Pain in Rheumatic Disease, Including Validation the Questionnaire of AE-FS #### Organization Study ID Info **ID:** DS-00805 #### Organization **Class:** OTHER **Full Name:** Diakonhjemmet Hospital #### Secondary ID Infos **Domain:** REK **ID:** 656858 **Type:** REGISTRY ### Status Module #### Completion Date **Date:** 2030-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-16 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-01-17 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Diakonhjemmet Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Catastrophic thinking is a risk factor for a poor prognosis for pain in general and rheumatic disease in particular, which for many contributes to a behavioral pattern characterized by avoidance. Other people with long-term pain, on the other hand, have a pattern where they suppress thoughts and feelings of fear associated with pain, and push themselves to carry out activities. An inappropriate form of endurance can help maintain and intensify pain. The AE-FS is a short version of the Avoidance-Endurance Questionnaire with different subscales for maintaining activity despite pain. AE-FS can be of great clinical utility. The study of patients with rheumatic disease and long-term pain will validate a Norwegian version of the AE-FS as well as examine how the AE-FS seen in connection with other relevant questionnaires, including the Pain Catastrophizing Scale , reflects mechanisms for change in cognitive behavioral therapy for long-term pain. The effect of the intervention is evaluated with questionnaires at baseline/start of treatment, end of treatment, two months after end of treatment and after six months. **Detailed Description:** Background for the project Up to 30% of the adult population in Norway state that they have had long-term pain . Long-term pain in the musculoskeletal system accounts for 50% of disability cases and is the most frequent cause of long-term absence. This group includes rheumatic disease, back and neck disorders, pelvic pain and shoulder problems. Rheumatic disease is a collective term for over 200 different diseases that are divided into inflammatory rheumatic disease (arthritis, spondyloarthritis, psoriatic arthritis, connective tissue diseases and vasculitis), degenerative diseases (arthrosis) and soft tissue rheumatism (fibromyalgia). Fibromyalgia is characterized by widespread and long-lasting muscle pain and occurs in about 5% of the population. The pain picture in rheumatic disease is complex with different pain mechanisms and frequent comorbidity with sleep difficulties, fatigue and psychological problems. The pain can be linked to inflammation and to structural changes, but also to changes in the central nervous system. With support from Stiftelsen Dam, the Unit for mental health services in somatics and the Unit for research and innovation at the Adult Psychiatric Department Vinderen and the Clinic for Rheumatology, Outpatient Clinic and Research, Diakonhjemmet Hospital, have developed an intervention based on clinical health psychology and cognitive behavioral therapy. The target group is primarily patients with long-term pain and rheumatic disease. The treatment is described in a chapter in the Handbook of Clinical Health Psychology . A workbook for pain has been developed, following revisions and feedback from 15 individual patients and participants in 2 treatment groups (one physical and one digital) who have followed the scheme. The workbook contains knowledge about pain and pain management, describes measures and homework from session to session. The treatment offered in the project spans 8 sessions of 2 hours each and is carried out either digitally or by physical attendance. A corresponding manual has also been developed for individual treatment over approx. 10 sessions of 45 minutes. The patients are called in for a follow-up appointment 2 months after the ordinary termination. Negative thought and reaction and behavior patterns in long-term pain Catastrophic thinking is an inappropriate coping style where one overestimates the threat of pain, ponders the causes and is worried about the consequences. In arthritis, catastrophic thinking predicts more intense pain and severe depression symptoms and poorer physical function . In knee osteoarthritis, catastrophizing predicts a longer postoperative course in hospital, and more avoidance of physical activity . Some patients suppress thoughts associated with pain or the fear of it and push themselves to carry out activities. It represents an inappropriate and inflexible form of endurance, which can contribute to maintaining and intensifying pain. The short version AE-FS can be of great clinical value. A patient with high scores on the questionnaire may be in a vicious circle which in the long term increases pain and affects quality of life. The patient ignores the pain or the fear of it, and does not pay necessary attention to it. The form consists of 9 statements, 7 of them on two scales for mild and severe pain, respectively, where you must indicate whether and how often you have acted in this way in the last two weeks. Examples of statements are: "When I am in pain * I try not to take any notice of it. * I clench my teeth. * keep appointments even though I don't feel up to it. There are 7 answer options (never, almost never, seldom, sometimes, often, mostly and always). In addition, the patients are asked to indicate their mood and the possibility of depressive symptoms in the last two weeks, more specifically if they enjoy things just as ever and think they make decisions about as well as ever. Issues for the study 1. The AE-FS questionnaire can be of great clinical value for mapping behavior and thoughts in mild and severe pain, both to predict long-term pain and as an educational tool in the treatment of patients. In the project, we will validate the form, by assessing its suitability for our patient group and compliance with other validated forms which, among other things, measure pain, depressive symptoms, anxiety symptoms and function. 2. In the project, we also want to evaluate the feasibility and effect of the treatment for: 1. Pain, measured by the Brief Pain Inventory questionnaire - short form (Cleeland \& Ryan, 1994) 2. General symptoms, measured by the PROMIS-29 questionnaire (Patient reported outcomes measurement information system). 3. Quality of life/general health, measured by the EQ-5D-5L questionnaire (general health questionnaire). 4. Any other relevant questionnaires. 5. Feasibility and satisfaction, including attendance, dropouts, etc. 3. We also want to investigate whether negative thought and reaction and behavior patterns in long-term pain measured by AE-FS and/or PCS can predict and/or mediate treatment response when it comes to pain. 4. We also want to evaluate other possible predictors of treatment response, such as age, sex, duration of pain, etc. Method and implementation In the study, we will evaluate the effect of the intervention using questionnaires at baseline, at the start of treatment, at the end of treatment, at the booster time two months after the end of treatment and 6 months later. Suitable forms have been assessed in consultation with the reference group. We use the following forms: Brief Pain Inventory - short form ; PROMIS-29 (Patient reported outcomes measurement information system); generic EQ-5D-5L (general health and quality of life questionnaire), PCS (Pain Catastrophizing Scale), AE-FS (The avoidance-endurance questionnaire - short form, ), and four questions from the MCQ (MetaCognition Questionnaire) about positive assumptions about worry and an assumption that worry cannot be controlled, respectively. Patients must also fill in a background form upon inclusion with, among other things, demographic variables, and possibly simple "anchor questions" aimed directly at current issues. We will also register attendance and non-attendance, possibly from the patient record. Treatment within the project Cognitive behavioral therapy is the psychological approach that has the best evidence for long-term pain in general, and which is highlighted as a theoretical framework in EULAR's recommendations for patient education in rheumatic disease. Cognitive behavioral therapy is associated with better outcomes of rehabilitation for long-term pain in general, reduced pain intensity and less use of medication and health services. There is evidence that exposure therapy aimed at pain-related avoidance behavior reduces the symptoms of fibromyalgia . Work with pain-related imagery as well as motivation, goals and values and measures to strengthen compliance when using rules of action are also included. In addition, measures are taken to influence patterns of action characterized by inappropriate endurance and accompanying overload. Participants in the study/preparedness throughout the project period We plan to include up to 200 patients who participate in the treatment plan, either individually or treated in a course/group at the Unit for mental health services in somatics, Diakonhjemmet hospital. The patients included have both a rheumatic disorder and a long-term pain condition. All patients have an assessment interview with a psychologist associated with the project, before starting the treatment. There they will receive information about the treatment and the research project. They are told that participation in the project is voluntary and that it is perfectly fine to receive the treatment without participating in the research. If they then express that they are interested in participating in the research project, they will receive written and verbal information about the project (consent form), and information that, prior to the start of treatment, they will receive a link via SMS, where they can sign the consent and fill in the questionnaires. Alternatively, in the assessment interview, they will be given a written consent form and the questionnaires which they can hand in to the researchers in the study, possibly sending in a pre-stamped envelope. The included questionnaires are completed at inclusion/start of treatment, end of treatment, at the follow-up appointment 2 months after the end of ordinary treatment and 6 months later. In order to ensure privacy and good quality of the answers, the research participants are informed that the forms should be completed in quiet surroundings without public exposure. In the consent form, they will also receive information that the forms will only be used in the research and that they can contact the project manager throughout the project period if filling in the forms would result in negative reactions or the need for clarifying conversations. If necessary, they can have a conversation with the psychologist responsible for the treatment. Project group The project group for the study is divided into two parts, where the psychologists Elin Fjerstad, Torkil Berge and Ingrid Hyldmo are responsible for the development and implementation of the treatment and the researchers Kåre Osnes (project manager), Selle Aarrestad Provan, Rikke Helene Moe, Bente Bull-Hansen and Andrew Malcolm Garratt are responsible for the research part of the project. Everyone in the research group is employed at Diakonhjemmet hospital. Handling of data Patients fill in the questionnaires digitally via Nettskjema/TSD, alternatively on paper. The data that is collected on paper is stored de-identified and locked in the office of the project employee/archive. The data is transferred de-identified and stored on an access-controlled research server. The code list is stored in a separate access-controlled folder on the research server, where only the project manager and employees responsible for research logistics have access. The data will be anonymised (the code list will be deleted and other personally identifiable information will be removed) no later than five years after the end of the project (the end of the project is tentatively 31 December 2030). The data that is collected digitally via Nettskjema/TSD is transferred to an access-controlled folder in the research server. According to the new General Data Protection Regulation (GDPR), the controller at Diakonhjemmet hospital and project manager Kåre Osnes has an independent responsibility to ensure that the processing of personal data has legal basis. This project has legal basis in the EU's GDPR article 6 no. 1a and article 9 no. 2a, consent. The project will be assessed by the data protection representative and the research committee at Diakonhjemmet hospital. The results will be published in scientific journals, through the user organisations' magazines and websites, and spread through social media. The project is a collaborative project between the Department of Adult Psychiatry and the Center for treatment of Rheumatic and Musculoskeletal Diseases (REMEDY). REMEDY is an interdisciplinary research center led by Diakonhjemmet hospital in partnership with Oslo University Hospital. The research center aims to improve the treatment of musculoskeletal diseases and has a particular focus on intervention studies in people with auto-immune rheumatic diseases. The center is funded by the Research Council, which is a research center for clinical treatment, and by the Olav Thon Foundation Schedule Course and processing with collection of personal data: 2024-2027 Analyzes of research data: 2027-2028 Publication with writing of articles 2028-2030 ### Conditions Module **Conditions:** - Rheumatic Diseases - Pain, Chronic **Keywords:** - "Cognitive behavioral therapy" - Long-term pain - Avoidance-Endurance Questionnaire - Rheumatic disease ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** 200 patients with long-term pain and rheumtic disease, participate in cognitive behavioral therapy individually or in a group. The treatment consists of 8 sessions, 7 weekly sessions and a booster session 2 months after the end of treatment. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Cognitive behavioral therapy is the psychological approach in this study. It is associated with better outcomes of rehabilitation for long-term pain in general, reduced pain intensity and less use of medication and health services, sustaining factors that provide an understanding of how thoughts and feelings affect the experience of pain. An important aim is also a reduction in pain-related rumination and worry and changed metacognition that maintains inhibiting behavior and thought patterns. A workbook for pain has been developed. It contains knowledge about pain and pain management, describes measures and homework from session to session. The treatment consists of 8 sessions with 7 weekly sessions + 1 booster session 2 months after the end of treatment. **Intervention Names:** - Behavioral: Cognitive behavioral Therapy **Label:** Cognitive behavioral Therapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Cognitive behavioral Therapy **Description:** Cognitive behavioral therapy is the psychological approach in this study. It is associated with better outcomes of rehabilitation for long-term pain in general, reduced pain intensity and less use of medication and health services, sustaining factors that provide an understanding of how thoughts and feelings affect the experience of pain. An important aim is also a reduction in pain-related rumination and worry and changed metacognition that maintains inhibiting behavior and thought patterns. A workbook for pain has been developed. It contains knowledge about pain and pain management, describes measures and homework from session to session. The treatment consists of 8 sessions with 7 weekly sessions + 1 booster session 2 months after the end of treatment. . **Name:** Cognitive behavioral Therapy **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** 1. The AE-FS questionnaire can be of great clinical value for mapping behavior and thoughts in mild and severe pain, both to predict long-term pain and as an educational tool in the treatment of patients. In the project, we will validate the form, by assessing its suitability for our patient group and compliance with other validated forms which, among other things, measure pain, depressive symptoms, anxiety symptoms and function. **Measure:** Validation of AE-FS **Time Frame:** 8 months **Description:** In the project, we also to evaluate the feasibility of the treatment:Feasibility and satisfaction, including attendance, dropouts, etc. **Measure:** Evaluation of cognitive behavioral therapy for long-term pain in rheumatic disease - Feasibility **Time Frame:** 8 months **Description:** Pain, measured by the Brief Pain Inventory questionnaire - short form **Measure:** Evaluation of cognitive behavioral therapy for long-term pain in rheumatic disease - Pain **Time Frame:** 8 months **Description:** General symptoms, measured by the PROMIS-29 questionnaire (Patient reported outcomes measurement information system). **Measure:** Evaluation of cognitive behavioral therapy for long-term pain in rheumatic disease - General symptoms **Time Frame:** 8 months **Description:** Quality of life/general health, measured by the EQ-5D-5L questionnaire (general health questionnaire). **Measure:** Evaluation of cognitive behavioral therapy for long-term pain in rheumatic disease - Quality of life **Time Frame:** 8 months #### Secondary Outcomes **Description:** 3. We also want to investigate whether negative thought and reaction and behavior patterns in long-term pain measured by AE-FS and/or PCS can predict and/or mediate treatment response when it comes to pain. **Measure:** Analyses of predictors and mediators **Time Frame:** 8 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * A rheumatic disorder and a long term pain condition * Written consent Exclusion Criteria: * Participation in another therapy during the study periode **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** kare.osnes@diakonsyk.no **Name:** Kåre Osnes, PhD **Phone:** +47 92833866 **Role:** CONTACT **Contact 2:** **Email:** torkil.berge@diakonsyk.no **Name:** Torkil Berge, Psychologist **Phone:** +47 22 02 98 00 **Role:** CONTACT #### Locations **Location 1:** **City:** Oslo **Contacts:** ***Contact 1:*** - **Email:** kare.osnes@diakonsyk.no - **Name:** Kåre Osnes, PhD - **Phone:** +47 92833866 - **Role:** CONTACT ***Contact 2:*** - **Email:** torkil.berge@diakonsyk.no - **Name:** Torkil Berge, Psychologist - **Phone:** +47 22 02 98 00 - **Role:** CONTACT **Country:** Norway **Facility:** Diakonhjemmet Sykehus **Status:** RECRUITING **Zip:** 0319 #### Overall Officials **Official 1:** **Affiliation:** Diakonhjemmet Hospital **Name:** Erik Soegaard, PhD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Description:** IPD are not to be shared with other researshers **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15045 - Name: Rheumatic Diseases - Relevance: HIGH - As Found: Rheumatic Diseases - ID: M6323 - Name: Collagen Diseases - Relevance: HIGH - As Found: Rheumatic Diseases - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M29442 - Name: Chronic Pain - Relevance: HIGH - As Found: Pain, Chronic - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012216 - Term: Rheumatic Diseases - ID: D000003095 - Term: Collagen Diseases - ID: D000059350 - Term: Chronic Pain ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413901 **Brief Title:** TIP Repair of Distal Penile Hypospadias Using Rapidly Absorbable Braided Vs Slowly Absorbable Monofilament Sutures **Official Title:** TIP Repair of Distal Penile Hypospadias Using Rapidly Absorbable Braided Vs Slowly Absorbable Monofilament Sutures: A Prospective, Randomized Controlled Study #### Organization Study ID Info **ID:** N-421-2023 #### Organization **Class:** OTHER **Full Name:** Cairo University ### Status Module #### Completion Date **Date:** 2022-09-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-09-30 **Type:** ACTUAL #### Start Date **Date:** 2021-09-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-05 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cairo University #### Responsible Party **Investigator Affiliation:** Cairo University **Investigator Full Name:** Mohamed Abdelghany **Investigator Title:** lecturer **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Objective: To study the effect of tubularizing the urethral plate in DPH in children using 2 different absorbable suture materials, rapidly absorbable, braided 6/0 Vicryl and slowly absorbable monofilament 6/0 Polydioxanone, on complication rates. Patients and methods: A prospective, randomized controlled study conducted at the Urology Department, Cairo University Specialized Pediatric Hospital, Abou El Reesh, between September 2021 and September 2022. A total of 69 boys aged between 8 and 120 months with DPH were randomly divided into 2 groups: group(A) Vicryl included 39 boys and group(B) PDS included 30 boys. All boys were uncircumcised with no chordee and were primary repairs. TIP was the surgical technique used by a single pediatric urologist. Follow up was performed in outpatient clinic at 7 days, 1, 3, 6 and 12 months postoperatively. The complications and reoperation rates for both groups were compared. ### Conditions Module **Conditions:** - Hypospadias Repair ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 69 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** TIP hypospadias repair **Intervention Names:** - Procedure: TIP **Label:** Vicryl group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** TIP hypospadias repair **Intervention Names:** - Procedure: TIP **Label:** PDS group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - PDS group - Vicryl group **Description:** TIP hypospadias repair **Name:** TIP **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** urethrocutaneous fistula, wound infection, wound dehiscence, overall complications, and reoperation rates **Measure:** complication rate **Time Frame:** one year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Any child(aged from 6m to 12 years old) with distal penile hypospadias (DPH) ( uncircumcised, without chordae, with good penile size and urethral plate(candidates for T.I.P repair) Exclusion Criteria: * reccurent cases, * circumcised cases * other types of hypospadias rather than DPH, * presence of chordae, * poor urethral plate **Maximum Age:** 12 Years **Minimum Age:** 6 Months **Sex:** MALE **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Cairo University **Zip:** 02 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014564 - Term: Urogenital Abnormalities - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000010409 - Term: Penile Diseases - ID: D000005832 - Term: Genital Diseases, Male - ID: D000091662 - Term: Genital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000000013 - Term: Congenital Abnormalities ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10071 - Name: Hypospadias - Relevance: HIGH - As Found: Hypospadias - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M17314 - Name: Urogenital Abnormalities - 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: M13320 - Name: Penile Diseases - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M8944 - Name: Genital Diseases, Male - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007021 - Term: Hypospadias ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413888 **Acronym:** whipple **Brief Title:** Nasogastric Decompression Following Pancreaticoduodenectomy **Official Title:** Routine Nasogastric Drainage vs. No Drainage Using Nasogastric Tube After Pancreaticoduodenectomy: A Randomized Control Trial [NCT ID Not Yet Assigned] #### Organization Study ID Info **ID:** H-43383 #### Organization **Class:** OTHER **Full Name:** Baylor College of Medicine ### Status Module #### Completion Date **Date:** 2023-12-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-05-31 **Type:** ACTUAL #### Start Date **Date:** 2018-06-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Baylor College of Medicine #### Responsible Party **Investigator Affiliation:** Baylor College of Medicine **Investigator Full Name:** Omar Barakat **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:** Pancreaticoduodenectomy (PD) remains the gold-standard operation for peri-ampullary neoplasms. Traditionally, gastric decompression via nasogastric intubation has been employed postoperatively to prevent nausea, vomiting, aspiration pneumonia, anastomotic leakage and delayed gastric emptying. Recently, the implementation of ERAS protocol recommended against routine use of nasogastric tube following PD. however, limited data exists surrounding the identification of those patients needing NGT decompression in the immediate postoperative period. Therefore, we initiated a large prospective randomized controlled trial to evaluate the clinical outcomes of patients who retained the NGT post-PD versus those who had it removed at the end of the procedure. This study aims to assess the effectiveness of nasogastric decompression in PD recovery, with the primary endo point being the need for and impact of NGT in the postoperative recovery. The secondary endpoint will examined the re-insertion rate of NGT and identify factors that necessitate its use in the immediate postoperative period. ### Conditions Module **Conditions:** - Pancreatic Head Neoplasm - Delayed Gastric Emptying - Post Operative Ileus - Whipple Procedure ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Two groups of patients. Group 1 patients will have NGT placed in the operating room and continued in the immediate postoperative recovery period. Group 2 patients will have oropharyngeal gastric tube inserted in the operating room and removed at the end of the procedure. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 230 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Procedure: pancreaticoduodenectomy **Label:** Group A ( No NGT) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Procedure: pancreaticoduodenectomy **Label:** Group B (NGT Retained) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group A ( No NGT) - Group B (NGT Retained) **Description:** Surgical removal of the head of the pancreas, duodenum, extrahepatic bile duct, distal stomach, and proximal jejunum. Group A cohort will not have NGT placed in the postoperative period. Whereas, group B will have the NGT retained in the posoperative period **Name:** pancreaticoduodenectomy **Other Names:** - Whipple **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Severity of post operative complications was graded according to the Clavien-Dindo classification system adopted for pancreaic surgery, which relies on the type of treatment used for each complication with scores range from 1-4, and any complication graded \>2 considered a major complication. **Measure:** to assess whether nasogastric decompression following a whipple procedure will reduce the incidence and severity of postoperative complications **Time Frame:** 30-days postoperatively #### Secondary Outcomes **Description:** Patient will be considered to undergo nasogastric decompression with nasogastric tube if he/she demonstrated clinical evidence of postoperative ileus and delayed gastric emptying as defined according to the consensus definition proposed by the international study group of pancreatic surgery (ISGPS), the severity of which was classified into 3 grades (A,B, and C) based on clinical course and postoperative management such as the need nausea and vomiting and inability to tolerate solid oral intake by the end of the first postoperative week. **Measure:** Examined the re-insertion rate of Nasogastric tube following pancreaticoduodenectomy **Time Frame:** 30- days postoperatively **Description:** To identify preoperative factors such as obesity with BMI 30 or more, Preoperative uncontrolled diabtes, older age (over 70), gender (male/female), histroy of gastric outlet obstruction, primary diagnosis (malignant disease vs benign). Intra-operative factor such such as the length of the procedure, blood loss, any concurrent procedure such as extensive lysis of adhesions, colon resection; and postoperative factors including postoperative blood counts, phosphorus and magnesium levels, blood sugar level, and postoperative complications. These factors will be assessed using logistic regression analysis to predict the necessity of nasogastric decompression in the postoperative period following the whipple procedure. **Measure:** identify factors that necessitated its use in the immediate postoperative period **Time Frame:** 30 days postoperatively ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All patients 18 years of age or older * Patients undergoing successful pancreaticoduodenectomy for benign or malignant neoplasm. Exclusion Criteria: * Patients who does not complete the procedure due to locally advanced or metastatic disease discovered during the procedure. * Patient who requires prolong postoperative intubation in the postoperative period. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Houston **Country:** United States **Facility:** Baylor college of medicine **State:** Texas **Zip:** 77030 #### Overall Officials **Official 1:** **Affiliation:** Baylor College of Medicine **Name:** Omar Barakat, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013272 - Term: Stomach Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000010243 - Term: Paralysis - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M20685 - Name: Gastroparesis - Relevance: HIGH - As Found: Delayed Gastric Emptying - ID: M25585 - Name: Ileus - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: HIGH - As Found: Head Neoplasms - ID: M16062 - Name: Stomach 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: M13157 - Name: Paralysis - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: T2445 - Name: Gastroparesis - Relevance: HIGH - As Found: Delayed Gastric Emptying ### Condition Browse Module - Meshes - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000018589 - Term: Gastroparesis ### Intervention Browse Module - Browse Branches - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M22554 - Name: Pancrelipase - Relevance: LOW - As Found: Unknown - ID: M13114 - Name: Pancreatin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413875 **Brief Title:** Effectiveness of Education Specific to Menopause Symptoms **Official Title:** The Effect of Menopausal Symptoms Specific Education Given to Women in Menopause Via WhatsApp on Quality of Life and Genital Self-Image #### Organization Study ID Info **ID:** makale #### Organization **Class:** OTHER **Full Name:** Bartın Unıversity ### Status Module #### Completion Date **Date:** 2023-12-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-12-31 **Type:** ACTUAL #### Start Date **Date:** 2023-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** The Scientific and Technological Research Council of Turkey #### Lead Sponsor **Class:** OTHER **Name:** Bartın Unıversity #### Responsible Party **Investigator Affiliation:** Bartın Unıversity **Investigator Full Name:** Ebru Cirban Ekrem **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:** Objective: To determine the effect of menopausal symptom-specific education given to menopausal women via WhatsApp on their quality of life and genital self-image. Methods: The population of the study, which has a classical experimental design with a pretest-posttest control group, was comprised of women between the ages of 45-65 across Turkey. According to the power analysis performed in the G\*Power3.1 Program, the sample size was calculated as 64 participants for each group, with an effect size (0.418), 95% power and 0.05 type 1 error, and was completed with 158 women. Data were collected with the Introductory Information Form, the Menopause-Specific Quality of Life Scale (MSQLS) and the Female Genital Self-Image Scale (FGSIS). The research was conducted online via WhastApp in a pretest-educational intervention-posttest design. The data were analyzed in the SPSS 26.0 package program. **Detailed Description:** Objective: To determine the effect of menopausal symptom-specific education given to menopausal women via WhatsApp on their quality of life and genital self-image. Methods: The population of the study, which has a classical experimental design with a pretest-posttest control group, was comprised of women between the ages of 45-65 across Turkey. According to the power analysis performed in the G\*Power3.1 Program, the sample size was calculated as 64 participants for each group, with an effect size (0.418), 95% power and 0.05 type 1 error, and was completed with 158 women. Data were collected with the Introductory Information Form, the Menopause-Specific Quality of Life Scale (MSQLS) and the Female Genital Self-Image Scale (FGSIS). The research was conducted online via WhatsApp between April and December 2023, using the snowball sampling method with participants who met the inclusion criteria. In snowball sampling, first of all, contact was made with one of the units of the universe. With the help of the contacted unit, a third unit was contacted. In this way, the sample size expanded like a snowball growing. First, the participants around the researchers were reached, and then the participants' circle was reached. The data collection form was sent online to the participants in the sample and they were asked to fill it out (pre-test). Two separate groups were opened on WhatsApp for the intervention and control groups. It has been stated in the literature that video and informative message interventions performed three days a week for 3-6 weeks are effective. For this reason, in this study, the educational intervention included sending an informative video once a week and informative messages three days a week for four weeks.18,19 In the intervention part of the study, after all participants filled out the data collection form, the intervention group was informed about Menopause once a week on the first day of each week for four weeks. An information video prepared in line with the topics specified in the Symptom-Specific Training Booklet has been sent. Informative messages were sent via WhatsApp three days a week, in parallel with the training topic of each week (training intervention). No educational intervention was given to the control group. After the training, a data collection form was sent to both the intervention and control groups via WhatsApp and the participants were asked to fill it out again (posttest). After the final test phase of the research was completed, training videos and informative messages were sent to the participants in the control group via WhatsApp. The data collection form was filled out using the self-report method in approximately 10 minutes. ### Conditions Module **Conditions:** - Menopause **Keywords:** - Genital image - menopause - woman - symptom - quality of life ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The population of the study, which has a classical experimental design with a pretest-posttest control group, was comprised of women between the ages of 45-65 across Turkey. According to the power analysis performed in the G\*Power3.1 Program, the sample size was calculated as 64 participants for each group, with an effect size (0.418), 95% power and 0.05 type 1 error, and was completed with 158 women. Data were collected with the Introductory Information Form, the Menopause-Specific Quality of Life Scale (MSQLS) and the Female Genital Self-Image Scale (FGSIS). The research was conducted online via WhastApp in a pretest-educational intervention-posttest design. The data were analyzed in the SPSS 26.0 package program. ##### Masking Info **Masking:** SINGLE **Masking Description:** Participants were informed about the research, and then participants who agreed to participate in the research were given a number respectively. After the targeted sample number was reached, all participants were divided into intervention and control groups using a simple random numbers table. **Who Masked:** - PARTICIPANT **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 158 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The data collection form was sent online to the participants in the sample and they were asked to fill it out (pre-test). Two separate groups were opened on WhatsApp for the intervention and control groups. For this reason, in this study, the educational intervention included sending an informative video once a week and informative messages three days a week for four weeks.In the intervention part of the study, after all participants filled out the data collection form, the intervention group was informed about Menopause once a week on the first day of each week for four weeks. An information video prepared in line with the topics specified in the Symptom-Specific Training Booklet has been sent. Informative messages were sent via WhatsApp three days a week, in parallel with the training topic of each week (training intervention).After the training, a data collection form was sent to the intervention group via WhatsApp and the participants were asked to fill it out again (posttest). **Intervention Names:** - Other: education **Label:** enterprise group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The data collection form was sent online to the participants in the sample and they were asked to fill it out (pre-test). No educational intervention was given to the control group. After the training, a data collection form was sent to the control group via WhatsApp and the participants were asked to fill it out again (posttest). **Label:** control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - enterprise group **Description:** Education Specific to Menopause Symptoms **Name:** education **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Education Specific to Menopause Symptoms **Measure:** The total quality of life scale score of the intervention group that received training on menopause symptoms was better than the control group. **Time Frame:** 4 weeks **Description:** Education Specific to Menopause Symptoms **Measure:** The genital self-image scale total score of the intervention group that received training on menopause symptoms was better than the control group. **Time Frame:** 4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * between the ages of 45-65 between April and December 2023, * in the pre/peri/postmenopausal period, * not receiving hormone replacement therapy in the last 6 months, * not having had a gynecological operation, * women who have internet access, (6) use a smartphone, * voluntarily agree to participate in the study. Exclusion Criteria: * Those who filled out the data collection form incompletely **Gender Based:** True **Gender Description:** Menopausal women between the ages of 45-65 **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 45 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bartin **Country:** Turkey **Facility:** Ebru Cirban Ekrem **Zip:** 74100 ### IPD Sharing Statement Module **Description:** The research is in the article writing phase. It will be published as an article. **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 - ID: T6036 - Name: Menopause - Relevance: HIGH - As Found: Menopause ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413862 **Brief Title:** Ciprofol Versus Propofol in Patients Undergoing Painless Hysteroscopy **Official Title:** Efficacy and Safety of Ciprofol Versus Propofol in Patients Undergoing Painless Hysteroscopy #### Organization Study ID Info **ID:** Ciprofol in hysteroscopy #### Organization **Class:** OTHER **Full Name:** Baoding First Central Hospital ### Status Module #### Completion Date **Date:** 2024-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-06-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-10 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Baoding First Central Hospital #### Responsible Party **Investigator Affiliation:** Baoding First Central Hospital **Investigator Full Name:** Lei Zhu **Investigator Title:** Chief Physician **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Ciprofol exhibits comparable efficacy to that of propofol, and is associated with less injection pain rate, fewer adverse events, higher patient satisfaction, and more stable hemodynamics when used for general anesthesia during the painless hysteroscopy. **Detailed Description:** In this study, we found that sedation success rate was 100% in both ciprofol group and propofol group during the painless hysteroscopy. The incidence rate of injection pain and the intensity of pain in the ciprofol group were significantly lower than the propofol group. Also, the ciprofol group had lower incidence rate and severity level of adverse events and higher patient satisfaction. In addition, SBP, DBP, and MAP values in propofol group were found to be significantly lower than those in ciprofol group at the time of cervical dilation and of consciousness recovery. ### Conditions Module **Conditions:** - Painless Hysteroscopy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 188 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Ciprofol **Label:** Ciprofol group (ciprofol combined with alfentanil) **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Propofol **Label:** Propofol group (propofol combined with alfentanil) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Ciprofol group (ciprofol combined with alfentanil) **Description:** The experimental group was slowly injected with ciprofol for 30 seconds (0.4mg/kg, Haisike Pharmaceutical Co., Ltd., Liaoning, China, batch number 20220911). **Name:** Ciprofol **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Propofol group (propofol combined with alfentanil) **Description:** The control group was slowly injected with propofol for 30 seconds (2mg/kg, Guorui Pharmaceutical Co., Ltd., Sichuan, China, batch number 22102914). **Name:** Propofol **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The injection pain was defined as the pain reported verbally by patients during the first injection of the investigational drugs (ciprofol or propofol). The Numerical Rating Scale (NRS) was used to evaluate the pain level. The anesthesiologist asks the patient during the first injection of the investigational drug (ciprofol or propofol), "Do you feel arm pain from the injection? Patients who answered "yes" was asked to describe the level of the pain (a score of 0 to 10 indicated "painless" to "unbearable pain"). The pain level was divided into painless (0 points), mild pain (1-3 points), and moderate to severe pain (4-10 points). **Measure:** Injection pain **Time Frame:** 24 hours within hysteroscopy #### Secondary Outcomes **Description:** No more than 5 supplementary doses within 15 minutes **Measure:** Sedation success rate **Time Frame:** 24 hours within hysteroscopy **Description:** the absence of any alternative sedatives/anesthetic drugs after the initial administration of the investigational drugs **Measure:** Anesthesia success rate **Time Frame:** 24 hours within hysteroscopy **Description:** the time from starting the administration of investigational drugs to the MOAA/S score ≤ 1 **Measure:** time for successful anesthesia induction **Time Frame:** 24 hours within hysteroscopy **Description:** the time from the last administration of investigational drugs to awaken **Measure:** recovery time **Time Frame:** 24 hours within hysteroscopy **Description:** ephedrine, atropine **Measure:** use of rescue drugs **Time Frame:** 24 hours within hysteroscopy **Description:** times of supplementing ciprofol or propofol **Measure:** times of supplementing ciprofol or propofol **Time Frame:** 24 hours within hysteroscopy **Description:** nausea, vomiting, hypoxemia (blood oxygen saturation \< 90% and lasting \> 30 seconds), bradycardia (heart rate \< 55 beats/minute), hypotension (systolic blood pressure reduced by 20% compared to baseline), body movement (patient's unconscious limb movements) during the examination **Measure:** adverse events **Time Frame:** 24 hours within hysteroscopy **Description:** graded based the National Cancer Institute Common Terminology Criteria for the Classification of Adverse Events (CTCAE) version 5.0, and divided into grade 1 (mild), grade 2 (moderate), grade 3 (severe or medically significant but not immediately life threatening), grade 4 (events with life-threatening consequences needing urgent intervention), grade 5 (death related to the adverse events) **Measure:** severity level of adverse events **Time Frame:** 24 hours within hysteroscopy **Description:** using a 10-point scale, with 1 point indicating extreme dissatisfaction and 10 points indicating very satisfied **Measure:** patient satisfaction **Time Frame:** 24 hours within hysteroscopy **Description:** The systolic blood pressure in mmHg, diastolic blood pressure in mmHg, mean arterial pressure in mmHg, blood oxygen saturation in %, and heart rate in bpm were recorded before anesthesia induction (T0), after anesthesia induction (T1), at cervical dilation (T2), and at consciousness recovery (T3) **Measure:** comparison of vital signs before and after administration **Time Frame:** 24 hours within hysteroscopy ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. age ≥ 18 years old; 2. undergoing hysteroscopy examination and requiring intravenous anesthesia; 3. American Society of Anesthesiologists (ASA) physical status I to II; 4. without communication difficulties, and able to cooperate with intervention implementation; 5. participating in this trial voluntarily, and signing an informed consent form; Exclusion Criteria: 1. with contraindications for hysteroscopy examination (such as cervical stenosis, difficulty in cervical dilation, reproductive tract infections such as vaginitis and cervicitis) or allergies to the intended anesthetic drugs; 2. with severe cardiac insufficiency, liver and kidney dysfunction, and other major diseases; 3. with a history of uterine surgery within the past three months; 4. body temperature above 37.5 ℃ before the anesthesia; 5. long-term use of sedative or analgesic drugs. **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** zhuleizlzl@outlook.com **Name:** Lei Zhu **Phone:** +86-13785214850 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** the First Central Hospital of Baoding **Name:** Lei Zhu **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000006993 - Term: Hypnotics and Sedatives - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018686 - Term: Anesthetics, Intravenous - ID: D000018681 - Term: Anesthetics, General - ID: D000000777 - Term: Anesthetics ### 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: M18307 - Name: Propofol - Relevance: HIGH - As Found: Symptoms - ID: M18320 - Name: Alfentanil - Relevance: LOW - As Found: Unknown - ID: M10043 - Name: Hypnotics and Sedatives - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M20766 - Name: Anesthetics, Intravenous - Relevance: LOW - As Found: Unknown - ID: M20761 - Name: Anesthetics, General - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000015742 - Term: Propofol ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413849 **Brief Title:** Telephone-coached "Graphic Narrative" Bibliotherapy for Dementia Caregivers **Official Title:** Telephone-coached "Graphic Narrative" Bibliotherapy for Informal Caregivers of People With Dementia #### Organization Study ID Info **ID:** P0047108 #### Organization **Class:** OTHER **Full Name:** The Hong Kong Polytechnic University ### Status Module #### Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-09 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The Hong Kong Polytechnic University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study aims to assess the efficacy of telephone-coached graphic narrative bibliotherapy in improving dementia caregiver depressive symptoms compared with the booklet group. **Detailed Description:** This is a two-arm cluster randomized controlled trial using a repeated-measures design to examine the effects of telephone-coached graphic narrative bibliotherapy on 128 (64 per group) informal caregivers of people with dementia. Participants in the intervention group will receive eight weekly telephone-coached graphic narrative bibliotherapy sessions, plus two face-to-face booster sessions and two follow-up sessions. The control group will receive an education booklet and check-in calls. Caregiver depressive symptoms, stress and anxiety, caregiving appraisal, care-recipient neuropsychiatric symptoms, and quality of life will be measured to test the intervention's effects immediately after completion and at a 6-month follow-up. ### Conditions Module **Conditions:** - Dementia Caregiver - Depressive Symptoms - Caregiving Appraisal ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 128 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Eight weekly sessions of telephone-coached graphic narrative bibliotherapy **Intervention Names:** - Other: Telephone coached graphic narrative bibliotherapy **Label:** Graphic narrative bibliotherapy **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Reading an educational booklet **Intervention Names:** - Other: Control group **Label:** Control group **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Graphic narrative bibliotherapy **Description:** Eight weekly sessions of telephone coached graphic narrative bibliotherapy **Name:** Telephone coached graphic narrative bibliotherapy **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Control group **Description:** Reading educational booklet **Name:** Control group **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Depressive symptoms will be measured with the Chinese version of the Depression Anxiety Stress Scale-21. It is a 4-point Likert scale consisting of 21 items that measure levels ofdepression, anxiety, and stress in participants. Higher scores indicategreater severity of mental health problems. **Measure:** Changes in depressive symptoms **Time Frame:** Pre-intervention, immediately post-intervention, 6 months post-intervention #### Secondary Outcomes **Description:** Caregiving appraisal will be assessed using the Caregiving Appraisal Scale. It is a 26-item Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores on this scale indicate more positive caregiving appraisal. **Measure:** Changes in caregiving appraisal **Time Frame:** Pre-intervention, immediately post-intervention, 6 months post-intervention **Description:** Stress and anxiety will be measured with the stress and anxiety subscales of DASS-21 **Measure:** Changes in stress and anxiety **Time Frame:** Pre-intervention, immediately post-intervention, 6 months post-intervention **Description:** Patient neuropsychiatric symptoms: will be measured with the Neuropsychiatric Inventory (NPI). NPI evaluates 12 common neuropsychiatric disturbances in dementia **Measure:** Changes in patient neuropsychiatric symptoms **Time Frame:** Pre-intervention, immediately post-intervention, 6 months post-intervention **Description:** Quality of life will be measured with the Quality of Life-Alzheimer's Disease Scale. It is a 13-item 4-point Likert scale to measure the quality of life for adults with or without dementia **Measure:** Changes in quality of life **Time Frame:** Pre-intervention, immediately post-intervention, 6 months post-intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * provide unpaid care to a person diagnosed with early to moderate stage dementia; * provide at least 14 hours of care a week for at least 3 months * aged 18 years or above * able to read * have depressive symptoms * use a message application Exclusion Criteria: * with an unstable physical or mental condition * with cognitive impairment * receiving medical, psychological, or psychiatric treatment for depression * have been included in another interventional study **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### 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: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6904 - Name: Dementia - Relevance: HIGH - As Found: Dementia - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depressive Symptoms - ID: M7061 - Name: Depressive Disorder - 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: M21836 - Name: Neurocognitive Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003704 - Term: Dementia - ID: D000003863 - Term: Depression ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413836 **Acronym:** aPDT **Brief Title:** Evaluation of Photodynamic Therapy in Pieces With Presence of Fistula. **Official Title:** Effect of the Photodynamic Therapy Mediated by Methylene Blue in Surfactant Medium as an Adjuvant in the Treatment of Parts With Apical Periodontitis and the Presence of Fistula: A Randomized, Controlled Double-blind Clinical Trial #### Organization Study ID Info **ID:** UCUUNINOVE #### Organization **Class:** OTHER **Full Name:** University of Nove de Julho ### Status Module #### Completion Date **Date:** 2026-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Nove de Julho #### Responsible Party **Investigator Affiliation:** University of Nove de Julho **Investigator Full Name:** Renato Araujo Prates **Investigator Title:** Resercher **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 adjuvant antimicrobial photodynamic therapy (aPDT) can help in the treatment in patients with pieces with apical periodontitis and the presence of fistula, in terms of reducing symptoms, resolution of fistula and the clinical signs of inflammation at the oral mucose, as well as, evaluation radiographic parameters. Participants will undergo conventional endodontic treatment at Group I (n=15) and will undergo conventional endodontic treatment combined with antimicrobial photodynamic therapy at Group II(n=15). **Detailed Description:** The calculation of the sample size was conducted with the statistical software G-Power 3.1 applying the chi-square homogeneity test. Identical sample sizes were considered for the aPDT group and the sham group. The percentage of type error was set at 5% and the statistical power at 80%, obtaining n = 30 considering 10% losses. The distribution of data within each group and the homogeneity of the variants will be verified for the choice of an analysis of variance or not. With this information the most proper statistical test will be conducted. The sample size calculation is based on the literature and a 5% significance level will be adopted ### Conditions Module **Conditions:** - Periodontitis - Fistula **Keywords:** - Periodontitis - Fistula aPDT - Methylene Blue ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Control Group (1): Mechanized endodontic treatment with CaOH (calcium hydroxide) medication between sessions. This medicine is the most commonly used in all conventional endodontic treatments. Study Group (2:) Mechanized endodontic treatment with CaOH (calcium hydroxide) medication following application of photodynamic therapy with methylene blue applied in surfactant medium. ##### Masking Info **Masking:** DOUBLE **Masking Description:** All participants will receive conventional endodontic treatment. The study group will receive antimicrobial photodynamic therapy with methylene blue application followed by active diode laser illumination. The control group will receive methylene blue solution and a simulation of laser application, which will be achieved by using an aluminum foil barrier placed at the tip of the equipment to block light in the control group. During this process, the participant will receive googles which aid eye protection and helps masking. The operator will wear protective glasses, which will aid in protection. Pre-irradiation and irradiation times will be the same at both groups. **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** antimicrobial photodynamic therapy using methylene blue in surfactant solution **Intervention Names:** - Device: aPDT - Procedure: Endodontic treatment **Label:** aPDT Therapy **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Endodontic treatment conventional treatment **Intervention Names:** - Procedure: Endodontic treatment **Label:** conventional treatment **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - aPDT Therapy **Description:** Mechanized endodontic treatment using an endodontic rotatory device (DENTSPLY) will be used to prepare the root canals. Following, it will be applied the methylene blue solution in surfactant medium and after 1 minute a diode laser equipment (DMC THERAPY/EC, Sao Carlos, Brazil) will be used to shine light at a wavelength of 660nm, 100 mW (miliWatts) and irradiation time of 3 min. CaOH (calcium hydroxide) paste will be applied at the root canals canals as a long-term dressing for endodontic treatment.. **Name:** aPDT **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - aPDT Therapy - conventional treatment **Description:** Mechanized endodontic treatment using an endodontic rotatory device (DENTSPLY) will be used to prepare the root canals. Following, it will be applied the methylene blue solution in surfactant medium and after 1 minute a diode laser equipment (DMC, THERAPY/EC, Sao Carlos, Brazil) will be used with an aluminium foil at the tip of the equipment to block light and use during 3 min as study group. CaOH (calcium hydroxide) will be applied at the root canals as a long-term dressing for endodontic treatment. **Name:** Endodontic treatment **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Clinical observation to check presence or absence of fistula **Measure:** Fistula presence **Time Frame:** Day 15 #### Secondary Outcomes **Description:** Radiolucent radiograph analysis defining improvement or absence of improvement of the bone lesion. **Measure:** Radiographic register **Time Frame:** Day 0 and Day 30 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Patients must have a single-rooted tooth with apical periodontitis and the presence of fistula. Patients must be over 18 years of age. Exclusion Criteria: Patients with comorbidities such as cancer, diabetes, coagulation diseases, and anemia; Patients undergoing orthodontic treatment; Patients with periodontal pockets deeper than 4 mm; Patients taking antibiotics; Pregnant or lactating patients; Patients with parts that present the impossibility of performing absolute isolation. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** caritowince@gmail.com **Name:** Carolina Wince **Phone:** 099637248 **Role:** CONTACT #### Locations **Location 1:** **City:** Montevideo **Contacts:** ***Contact 1:*** - **Email:** caritowince@gmail.com - **Name:** Carolina Wince - **Phone:** 099637248 - **Role:** CONTACT **Country:** Uruguay **Facility:** UCU **Status:** RECRUITING **Zip:** 11200 #### Overall Officials **Official 1:** **Affiliation:** University of Nove de Julho **Name:** Renato Prates **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010510 - Term: Periodontal Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000020763 - Term: Pathological Conditions, Anatomical ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M13427 - Name: Periodontitis - Relevance: HIGH - As Found: Periodontitis - ID: M13395 - Name: Periapical Periodontitis - Relevance: LOW - As Found: Unknown - ID: M8532 - Name: Fistula - Relevance: HIGH - As Found: Fistula - ID: M13419 - Name: Periodontal Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010518 - Term: Periodontitis - ID: D000005402 - Term: Fistula ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: BDCA - Name: Bone Density Conservation Agents ### Intervention Browse Module - Browse Leaves - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M14517 - Name: Pulmonary Surfactants - Relevance: LOW - As Found: Unknown - ID: M5381 - Name: Calcium - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M5398 - Name: Calcium, Dietary - Relevance: LOW - As Found: Unknown - ID: M11726 - Name: Methylene Blue - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413823 **Acronym:** VPC **Brief Title:** Prevention and Treatment of Cardiovascular Disease **Official Title:** Prevention and Treatment of Cardiovascular Disease: Protocol for the Assessment of Psychological, Neuropsychological Implications and Associated Disorders in Cardiology Patients #### Organization Study ID Info **ID:** 08/2024 #### Organization **Class:** OTHER **Full Name:** IRCCS Centro Neurolesi "Bonino-Pulejo" ### Status Module #### Completion Date **Date:** 2026-05-13 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-05-13 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-09 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** IRCCS Centro Neurolesi "Bonino-Pulejo" #### Responsible Party **Investigator Affiliation:** IRCCS Centro Neurolesi "Bonino-Pulejo" **Investigator Full Name:** Irene Cappadona **Investigator Title:** Psychologist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** In view of the close interrelationship between the various organs and systems of the body, which cannot be examined in a parceled fashion but rather as an integrated system, this study aims to consider the potential risks associated with cardiovascular disease. By identifying additional, often underestimated, altered functions that may affect the patient's quality of life and interfere with the performance of daily activities, this research study aims to evaluate the patient's functioning in an integrated manner to achieve a holistic view of the health and well-being of the patient and caregiver. **Detailed Description:** The study design is observational and is planned to last approximately 24 months. The overall duration will be related to the time required for enrollment of all planned subjects, data analysis and publication of results. The study aims to analyze and investigate the most common comorbidities in patients with cardiovascular disease. In addition, a specific focus will be devoted to the caregiver, who plays a key role for the cardiopathic patient. In detail, the objectives of the project are: 1. Evaluate the connection between cardiovascular disease and cognitive deficits; 2. Evaluate the main psychopathologies related to cardiovascular diseases (anxiety, depression); 3. Evaluate conditions and disorders associated with cardiovascular diseases (dysphagia, pneumophonic coordination disorders, respiratory sleep disorders); 4. Evaluate the effectiveness of psychoeducational intervention; 5. Evaluate the impact of cardiovascular disease on the caregiver. A minimum of 218 patients recruited from those afferent at the U.O.S.D. Cardiology with NICU P.O. "Piemonte" in Messina will participate in the survey. Statistical power analysis was performed using G\*Power software for a linear regression test, assuming a slope (H1) of 0.2 with a significance level (α) of 0.05 and a power (1 - β) of 0.85. The primary outcome variable considered for the calculation is the result of the SF-12 (or SF-36) test as a summary index of the effectiveness of psychoeducation. The calculation indicated a sample of 218 subjects as adequate for the purpose of detecting the hypothesized effect. Inclusion criteria: * Age between 45 and 85 years; * Confirmed diagnosis of cardiovascular disease; * Presence of chronic cardiovascular disease; * Absence of cognitive impairment or mild/moderate cognitive impairment (Mini Mental Score \>26); * Patient who has given informed consent personally or through Legal Representative. Exclusion Criteria: * Presence of severe psychiatric and neurological disorders. * Presence of end-stage oncological disease. * Severe visual impairment that cannot be corrected by dioptric lenses. Each patient who is eligible for this study will be presented with the purpose of the study and will freely decide whether to join. Only after the patient, or his/her Legal Representative, has agreed to participate in the investigation and signed the informed consent, can the Investigator proceed with the planned activities, detailed below. The patient's pathway should unfold as follows: Each patient's clinical data will be shared from a database, accessible to study collaborators through previously assigned login credentials. After checking inclusion and exclusion criteria and signing informed consents, patients will be taken on. 1. Baseline Examination. * Verification of inclusion and exclusion criteria; * Collection of demographic data; * Collection of the patient's clinical history; * Collection of information about the history of specific pathology and comorbidities. Thereafter, standardized tests for psychological, neuropsychological and associated clinical conditions will be administered. In addition, there will be at least one psychoeducation meeting that can also be conducted in groups. The following tests will be administered: * SF 36 Questionnaire or SF 12 Questionnaire; * MaugerI CaRdiac preventiOn-Questionnaire (MICRO-Q); * Mini-mental state examnation (MMSE); * Beck's Depression Inventory (BDI); * Beck's Anxiety Inventory (BAI); * Zarit Burden Inventory (ZBI); * Eat-10 test for monitoring swallowing ability and/or Swallowing Disturbance Questionnaire (SDQ). * STOPBANG questionnaire and/or 2ABN3M score; * Voice assessment using GIRBAS Scale and VHI. Feasibility will be assessed by considering adherence to the monitoring program through testicular assessments that will be performed not only at the baseline visit (T0) but also at the six-month follow-up (T1). 2. Follow-up visit. For each patient, the assessment tests will be repeated at the same time as the periodic follow-up visits. ### Conditions Module **Conditions:** - Cardiovascular Disease **Keywords:** - Cardiovascular disease - neuropsychological - depression - anxiety - psychoeducation - dysphagia - caregiver - sleep disorders - altered pneumophonic coordination ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 218 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** The primary outcome variable considered for calculation is the result of the SF-12 (or SF-36) test as a summary index of the effectiveness of psychoeducation. **Measure:** effectiveness of psychoeducation **Time Frame:** 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age between 45 and 85 years; * Confirmed diagnosis of cardiovascular disease; * Presence of chronic cardiovascular disease; * Absence of cognitive impairment or mild/moderate cognitive impairment (Mini Mental Score \>26); * Patient who has given informed consent personally or through Legal Representative Exclusion Criteria: * - Presence of severe psychiatric and neurological disorders * Presence of end-stage oncological disease. * Severe visual impairment that cannot be corrected by dioptric lenses **Maximum Age:** 85 Years **Minimum Age:** 45 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** A minimum of 218 patients recruited from those afferent at the U.O.S.D. Cardiology with NICU P.O. "Piemonte" in Messina will participate in the survey. Statistical power analysis was performed using G\*Power software for a linear regression test, assuming a slope (H1) of 0.2 with a significance level (α) of 0.05 and a power (1 - β) of 0.85. The primary outcome variable considered for the calculation was the result of the SF-12 (or SF-36) test as a summary index of the effectiveness of psychoeducation. The calculation indicated a sample of 218 subjects as adequate for the purpose of detecting the hypothesized effect ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** irene.cappadona@irccsme.it **Name:** Irene Cappadona, psychologist **Phone:** 3274409990 **Role:** CONTACT **Contact 2:** **Email:** irene.cappadona@irccsme.it **Name:** Irene Cappadona **Phone:** 3274409990 **Role:** CONTACT #### Locations **Location 1:** **City:** Messina **Contacts:** ***Contact 1:*** - **Email:** irene.cappadona@irccsme.it - **Name:** Irene Cappadona - **Phone:** 3274409990 - **Role:** CONTACT **Country:** Italy **Facility:** Irccs Centro Neurolesi Bonino Pulejo **State:** Sicilia **Status:** RECRUITING **Zip:** 98066 #### Overall Officials **Official 1:** **Affiliation:** IRCCS Centro Neurolesi "Bonino-Pulejo" **Name:** Irene Cappadona **Role:** PRINCIPAL_INVESTIGATOR ### 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 - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: M22242 - Name: Parasomnias - Relevance: LOW - As Found: Unknown - ID: M6882 - Name: Deglutition Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002318 - Term: Cardiovascular Diseases ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413810 **Brief Title:** A Randomised, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Effects of a Food Ingredient on Self-reported Stress in Healthy Adults **Official Title:** A Randomised, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Effects of a Food Ingredient on Self-reported Stress in Healthy Adults #### Organization Study ID Info **ID:** AFCRO-177 #### Organization **Class:** INDUSTRY **Full Name:** Unilever R&D ### Status Module #### Completion Date **Date:** 2024-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Atlantia Food Clinical Trials #### Lead Sponsor **Class:** INDUSTRY **Name:** Unilever R&D #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this study is to investigate if a food ingredient can improve stress in healthy adults who experience moderate symptoms of self-reported stress. The main question it aims to answer is if 4 weeks of daily intake of the ingredient reduces stress compared to 4 weeks of daily intake of a placebo product. Participants will: * consume both the test and placebo products for 4-weeks each in a randomised order, with 4 weeks in between * visit the test site 6 times over the 13 weeks * complete a series of assessments on stress and sleep quality and provide blood, stool and saliva samples **Detailed Description:** A double-blind, randomised, placebo-controlled, crossover study with 6 visits over 13-weeks. Participants will consume study product or placebo for two 4-week intervention periods. Primary Objective: To evaluate in healthy adults, experiencing moderate symptoms of self-reported stress, the effect of 4-week daily supplementation of a food ingredient versus placebo on stress. Secondary Objectives: To evaluate in healthy adults, experiencing moderate symptoms of self-reported stress, the effect of 4-week daily supplementation of a food ingredient versus placebo on: * Mood * Plasma GABA levels * Salivary cortisol awakening response (CAR) * Acute effects on stress * Faecal GABA ### Conditions Module **Conditions:** - Stress ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 49 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Calmarell **Label:** Food ingredient **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Other: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Food ingredient **Description:** Food ingredient **Name:** Calmarell **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Blinded placebo **Name:** Placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Change in Perceived Stress Scale (PSS) Total Score from baseline to end of intervention **Time Frame:** 4 weeks #### Secondary Outcomes **Measure:** Profile of Mood States Questionnaire (POMS) **Time Frame:** 4 weeks **Measure:** Plasma GABA levels **Time Frame:** 4 weeks **Measure:** Salivary cortisol awakening response **Time Frame:** 4 weeks **Measure:** VAS scale on acute effects on stress **Time Frame:** 30 hours **Measure:** Faecal GABA **Time Frame:** 4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * To be eligible for inclusion, the Participant must fulfil all the following criteria: 1. Be able to give written informed consent. 2. Be between 18 and 50 years of age. 3. Has a BMI between ≥ 18.0 and ≤ 30.0 kg/m2. 4. Have moderate stress, as measured on Cohen's Perceived Stress Scale (PSS), with a score between 14 and 26 (inclusive) at both Screening and Baseline Visits. 5. Is in general good health, as determined by the investigator. 6. Willing to consume the Study Product daily for the duration of the study and comply with the study procedures. Exclusion Criteria: * The presence of any of the following criteria will exclude the Participant from participating in the study: 1. Scores ≥10 on General Anxiety Disorder 7 item (GAD-7) questionnaire. 2. Scores ≥10 Patient Health Questionnaire 9 item (PHQ-9). 3. Participants who are pregnant or wish to become pregnant during the study. 4. Participants who are lactating and/or currently breastfeeding. 5. Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below: 1. Complete abstinence from intercourse two weeks prior to administration of the study product, throughout the human study, until the completion of follow-up procedures or for two weeks following discontinuation of the study product in cases where Participant discontinues the study prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks when they present to the clinic for the final visit). 2. Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that Participant. 3. Sexual partner(s) is/are exclusively female. 4. Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), tubal ligation, or contraceptive pill. The Participant must be using this method for at least one week prior to and one week following the end of the study. 5. Use of any intrauterine device (IUD) or contraceptive implant. The Participant must have the device inserted at least two weeks prior to the first screening visit, throughout the study, and two weeks following the end of the study. 6. Is hypersensitive to any of the components of the Study Product. 7. Have a significant acute or chronic coexisting illness such as such as uncontrolled hypertension, type 1 or 2 diabetes, cardiovascular diseases or any condition which may, in the opinion of the investigator, impact their ability to participate in the study or impact the study outcomes. 8. Use of systemic antibiotics within the 12 weeks prior to Visit 1. 9. Use of systemic immunosuppressant drugs, steroids, etc. within the 12 weeks prior to Visit 1. 10. Participants diagnosed and treated with prescribed medications for anxiety and depression in the 12 weeks prior to Visit 1. 11. Participants who have taken 3 doses laxative or anti-diarrheal medication in the past 12 weeks, at investigator discretion. 12. Herbal treatments for mood disorders or psychological conditions (e.g., valerian, St. John's Wort) within 4 weeks prior to Visit 1 or planning to start during the study period. 13. Disease such as coeliac disease, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, gastroesophageal reflux disease (GERD) that by the investigator's judgement, could interfere with the intestinal barrier function or have undergone significant gastrointestinal surgery (appendectomy and cholecystectomy acceptable). 14. Participants consuming prebiotics (containing fructans, galacto-oligosaccharides, psyllium husk, inulin as main component), or probiotics within last 4 weeks prior to Visit 1. 15. Participants consuming GABA or glutamate supplements, or any other supplements that are thought to directly affect digestive health and mental well-being within 4 weeks prior to Visit 1 which in the opinion of the investigator, impact the study outcomes. 16. Participants with a current history of drug (including illicit drug) and /or alcohol abuse at the time of enrolment. 17. Has received treatment involving experimental supplements in the past 4 weeks, at the discretion of the investigator. 18. Major changes in lifestyle (i.e., diet, dieting, exercise level, travelling, supplements) for duration of the study. 19. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study. 20. Any Participant who is an employee of the study site or an Atlantia Clinical Trials employee or their immediate family member or a member of their household. **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** amelia.jarman@unilever.com **Name:** Amelia C Jarman, PhD **Phone:** +447776490919 **Role:** CONTACT **Contact 2:** **Email:** simone.pyle@unilever.com **Name:** Simone Pyle, PhD **Phone:** +447999544694 **Role:** CONTACT #### Locations **Location 1:** **City:** Cork **Contacts:** ***Contact 1:*** - **Email:** egoodbody@atlantiatrials.com - **Name:** Emily Goodbody - **Phone:** +353 (0) 86-218-8787 - **Role:** CONTACT ***Contact 2:*** - **Email:** lvaz@atlantiatrials.com - **Name:** Lavita Vaz - **Phone:** +353 (0) 021-430-7442 - **Role:** CONTACT ***Contact 3:*** - **Name:** Timothy Dinan, Prof - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Ireland **Facility:** Atlantia Clinical Trials **State:** Co Cork **Zip:** T23 R50R #### Overall Officials **Official 1:** **Affiliation:** Atlantia Clinical Trials **Name:** Timothy Dinan, Prof **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413797 **Brief Title:** Little Cigar and Cigarillo Warnings for Youth **Official Title:** Strengthening Little Cigar and Cigarillo Warnings to Prevent Adolescent Use #### Organization Study ID Info **ID:** 23-2455 #### Organization **Class:** OTHER **Full Name:** UNC Lineberger Comprehensive Cancer Center #### Secondary ID Infos **ID:** 5R01CA260822-03 **Link:** https://reporter.nih.gov/quickSearch/5R01CA260822-03 **Type:** NIH ### Status Module #### Completion Date **Date:** 2026-02-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-02-28 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Cancer Institute (NCI) **Class:** FED **Name:** Food and Drug Administration (FDA) #### Lead Sponsor **Class:** OTHER **Name:** UNC Lineberger Comprehensive Cancer Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study explores the effect of the little cigars and cigarillos (LCC) warnings on youth who currently use, have ever used, or are susceptible to using LCCs, especially Black/African American youth. This study will inform the Food and Drug Administration (FDA) implementation of LCC warnings, which can reduce LCC use and lessen tobacco health disparities among youth. **Detailed Description:** Cigar use exposes youth to the addictive effects of nicotine during a critical developmental period and increases the risk of multiple cancers and premature death. Recent data indicate that cigars are the second most commonly used tobacco product by youth and that past 30-day cigar use is 7.6%, which translates into 1.1 million high school students. Of the three major types of cigars-large cigars, little cigars, and cigarillos-little cigars and cigarillos (LCCs) are the most commonly used in the US, particularly among younger people. LCC use also contributes to tobacco health disparities, as Black or African American youth use cigars more frequently than other youth. In 2016, the Food and Drug Administration (FDA) deemed LCCs subject to FDA regulation, requiring six rotating text-only warning statements to be on LCC packaging. Previous research has examined the effectiveness of LCC warnings in reducing youth willingness to use LCCs. Research from studies of cigarette warnings suggests that effective LCC warnings should employ images that illustrate negative health effects associated with use and a larger warning label prominently displayed on the pack. Among youth, health warnings on cigarette packs that contain both text statements and images are more effective and engaging than text-only warnings. However, evidence for cigarette warning labels cannot adequately inform implementation of improved LCC warnings for three reasons: 1) there is no evidence on the effectiveness of the FDA-mandated text-only LCC warnings on behavioral intentions or other outcomes among youth 2)courts have ruled that effective tobacco warnings on one type of tobacco product cannot be used to justify warnings on other types of tobacco, and 3) LCC users have different demographic and consumption profiles than cigarette users include more Black/African Americans and use LCCs on fewer days per month. ### Conditions Module **Conditions:** - Little Cigars and Cigarillos (LCC) Using **Keywords:** - cigarette warnings - youth - smoke cigars - nicotine addiction - cancer prevention - Black or African American youth ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** At the beginning of the baseline survey (day 1), participants will first consent to participate in the study and then complete a questionnaire about their LCC use and susceptibility, exposure to cigar advertising and warnings, and demographic characteristics, in addition to other measures. At the end of the baseline questionnaire, survey software will randomly assign participants to one of the 3 study conditions. ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 2100 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects will receive messages including FDA-proposed LCC warnings and Images in 30% size. Participants will be contacted each day to invite them to complete the survey for that day of the study protocol. **Intervention Names:** - Behavioral: Survey - Behavioral: FDA-proposed Text messages - Behavioral: Images **Label:** Text Image **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Subjects will receive text messages including FDA-proposed LCC warnings. Participants will be contacted each day to invite them to complete the survey for that day of the study protocol. **Intervention Names:** - Behavioral: Survey - Behavioral: FDA-proposed Text messages **Label:** Text-only **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Participants will be contacted each day to invite them to complete the survey for that day of the study protocol. **Intervention Names:** - Behavioral: Survey - Behavioral: Surgeon General Text messages **Label:** Control **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Control - Text Image - Text-only **Description:** For six subsequent days (days 2-7) participants will be contacted and asked to complete a daily survey. **Name:** Survey **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Text Image - Text-only **Description:** Participants will receive messages including FDA-proposed LCC warnings. **Name:** FDA-proposed Text messages **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - Text Image **Description:** Participants will receive messages including images in 30% size. **Name:** Images **Type:** BEHAVIORAL #### Intervention 4 **Arm Group Labels:** - Control **Description:** Participants will receive messages including Surgeon General Text-only Warnings. **Name:** Surgeon General Text messages **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The average willingness to use score will be measured by the average of the responses to the 2 survey questions scores. Question Scoring is on a scale of 1 to 5, where 1 indicates low willingness to use LCCs, and 5 indicates a willingness to use LCCs score. **Measure:** Willingness to use little cigar cigarillos (LCCs) **Time Frame:** Day 8 #### Secondary Outcomes **Description:** Past 7 days little cigar use will be measured with separate items for cigarillo and little cigar use by the survey. **Measure:** Past 7 days little cigar use **Time Frame:** Day 8 **Description:** Past 7 days cigarillos use will be measured with separate items for cigarillo and little cigar use by survey. **Measure:** Past 7 days cigarillos use **Time Frame:** Day 8 **Description:** little cigar cigarillo (LCC) susceptibility will be measured with 3 items by survey. **Measure:** little cigar cigarillos (LCCs) susceptibility **Time Frame:** Day 8 **Description:** Cognitive elaboration about dangers will be measured by the survey. **Measure:** Cognitive elaboration about dangers **Time Frame:** Days 1,2,3,4,5,6,7,8 **Description:** Cognitive elaboration about dangers will be measured by the survey. **Measure:** Cognitive elaboration about risk **Time Frame:** Day 8 **Description:** Cigar appeal will be measured by the survey. **Measure:** Cigar appeal **Time Frame:** Days 1,2,3,4,5,6,7,8 **Description:** Warning relevance will be measured by the survey. **Measure:** Warning relevance **Time Frame:** Days 1,2,3,4,5,6,7,8 **Description:** Warning negative affect/worry will be measured by the survey. **Measure:** Warning negative affect/worry **Time Frame:** Days 1,2,3,4,5,6,7,8 **Description:** Past 7 day little cigar cigarillos (LCCs) use will be measured by the survey. **Measure:** Past 7 day little cigar cigarillos (LCCs) use **Time Frame:** Day 8 **Description:** Knowledge of LCC harms will be measured by 13 items the survey. **Measure:** Knowledge of little cigar cigarillo (LCC) harms **Time Frame:** Day 8 **Description:** Beliefs about little cigar cigarillo (LCC) harms will be measured with 10 items by survey. **Measure:** Beliefs about little cigar cigarillo (LCC) harms **Time Frame:** Day 8 **Description:** LCC risk perceptions **Measure:** Little cigar cigarillo (LCC) risk perceptions **Time Frame:** Day 8 **Description:** Reactance to warnings will be measured by survey. **Measure:** Reactance to warnings **Time Frame:** Day 8 **Description:** Conversations about cigar health risks will be measured by survey. **Measure:** Conversations about cigar health risks **Time Frame:** Day 8 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Agree to provide their honest answers to the survey questionnaire. * Susceptible to using little cigars and cigarillos (LCC) or have ever used little cigars and/or cigarillos, or currently use little cigars and/or cigarillos in the past 30 days. * Age 15 - 20 years old * Currently living in US or US territory Exclusion Criteria: * Not able to verify they are not a bot using Completely Automated Public Turing test to tell Computers and Humans Apart (CAPTCHA). * Not able to answer a simple, random math question. **Healthy Volunteers:** True **Maximum Age:** 20 Years **Minimum Age:** 15 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jkristen@email.unc.edu **Name:** Kristen Jarman **Phone:** 919-445-4208 **Role:** CONTACT #### Locations **Location 1:** **City:** Chapel Hill **Contacts:** ***Contact 1:*** - **Email:** jkristen@email.unc.edu - **Name:** Kristen Jarman - **Phone:** 919-445-4208 - **Role:** CONTACT **Country:** United States **Facility:** Lineberger Comprehensive Cancer Center at University of North Carolina **State:** North Carolina **Zip:** 27514 #### Overall Officials **Official 1:** **Affiliation:** UNC Lineberger Comprehensive Cancer Center **Name:** Leah Ranney, PhD, MA **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### See Also Links **Label:** Clinical trials at UNC Lineberger **URL:** http://unclineberger.org/patientcare/clinical-trials/clinical-trials ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M19100 - Name: Behavior, Addictive - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M12478 - Name: Nicotine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413784 **Brief Title:** Examining The Effect of Chronotype Differences on Sleep Quality and Pregnancy Symptoms in Pregnant Women **Official Title:** Examining The Effect of Chronotype Differences on Sleep Quality and Pregnancy Symptoms in Pregnant Women #### Organization Study ID Info **ID:** 10840098-772.02-6181 #### Organization **Class:** OTHER **Full Name:** Istanbul Medipol University Hospital ### Status Module #### Completion Date **Date:** 2022-12-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-09-01 **Type:** ACTUAL #### Start Date **Date:** 2022-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Istanbul Medipol University Hospital #### Responsible Party **Investigator Affiliation:** Istanbul Medipol University Hospital **Investigator Full Name:** merve yilmaz menek **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:** Purpose: The aim of this study was to examine the effect of chronotype differences on sleep quality and pregnancy symptoms in pregnant women. Methods: Eighty-five pregnant women in the second trimester were included in the study. The chronotypes of pregnant women were determined using the Morningness-Eveningness Questionnaire (MEQ). Then, Oral Glucose Tolerance tests were performed on the participants between 24-28 weeks. Also, pregnant women's nausea and vomiting conditions with the Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) and sleep quality with Pittsburgh Sleep Quality Index (PSQI) were evaluated. **Detailed Description:** Purpose: The aim of this study was to examine the effect of chronotype differences on sleep quality and pregnancy symptoms in pregnant women. Methods: This study is a single-blind (participants), parallel trial. It was performed in line with the principles of the Declaration of Helsinki. The followings were the study's inclusion requirements: being between the ages of 18-40, having a singleton pregnancy, being in the second trimester, and not having any known chronic disease. Exclusion criteria are working night shifts, having a high-risk pregnancy, and having a neurological or orthopedic disease. Eighty-five pregnant women in the second trimester were included in the study. The chronotypes of pregnant women were determined using the Morningness-Eveningness Questionnaire (MEQ). Then, Oral Glucose Tolerance tests were performed on the participants between 24-28 weeks. Also, pregnant women's nausea and vomiting conditions with the Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) and sleep quality with Pittsburgh Sleep Quality Index (PSQI) were evaluated. ### Conditions Module **Conditions:** - Chronotype - Pregnancy Complications ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This study is a single-blind (participants), parallel trial ##### Masking Info **Masking:** SINGLE **Masking Description:** Participants were blind **Who Masked:** - PARTICIPANT **Primary Purpose:** OTHER #### Enrollment Info **Count:** 85 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Sleep quality, gestational diabetes and pregnancy symptoms of morning chronotype individuals were examined. **Intervention Names:** - Other: Morning chronotype **Label:** Morning Chronotype **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Sleep quality, gestational diabetes and pregnancy symptoms of Intermediate chronotype individuals were examined. **Intervention Names:** - Other: Intermediate chronotype **Label:** Intermediate chronotype **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Sleep quality, gestational diabetes and pregnancy symptoms of evening chronotype individuals were examined. **Intervention Names:** - Other: Evening chronotype **Label:** Evening chronotype **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Morning Chronotype **Description:** Sleep quality, gestational diabetes and pregnancy symptoms of morning chronotype individuals were examined. **Name:** Morning chronotype **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Intermediate chronotype **Description:** Sleep quality, gestational diabetes and pregnancy symptoms of intermediate chronotype individuals were examined. **Name:** Intermediate chronotype **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Evening chronotype **Description:** Sleep quality, gestational diabetes and pregnancy symptoms of evening chronotype individuals were examined. **Name:** Evening chronotype **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** It was used to measure the preference for a certain chronotype. This validated questionnaire evaluates individual differences in the degree to which respondents are aware and active at different times of the day. It has 19 items on sleep patterns and exhaustion. The responses to the scale items indicate preferences for waking and sleeping hours as well as the subjective "peak" times when respondents feel most refreshed. People were categorized as morningness chronotype (\>65), intermediate chronotype (53-64), or eveningness chronotype (score of \<52). The reliability of MEQ was 0.77 and the test alpha was equal to 0.78 (20). **Measure:** The Morningness-Eveningness Questionnaire (MEQ) **Time Frame:** 5 minutes **Description:** The PUQE is a scoring system for nausea and vomiting during pregnancy, which consists of three items. The original PUQE entailed rating the daily number of vomiting episodes, the length of nausea in hours per day, and the number of retching episodes per 12 hours. Its validation was confirmed by Koren et al. a total score of 3-6 is considered mild nausea and vomiting, a total score of 7-12 is considered moderate nausea and vomiting, and a total score of 13-15 is considered severe nausea and vomiting **Measure:** The Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) **Time Frame:** 5 minutes **Description:** Pregnant women undergo a 75 g OGTT test between 24 and 28 weeks of . A plasma fasting blood glucose\>126 mg/dL in a pregnant woman is considered overt diabetes (after confirmation) even if there is no prior history of diabetes. The OGTT test involves measurement of plasma glucose levels after an overnight fast (8 h), followed by oral consumption of 75 g glucose, and plasma glucose measurement at one and two hours. Gestational diabetes was defined as a fasting plasma glucose value\>92 mg/dL or a one-hour plasma glucose value\>180 mg/dL or a two-hour plasma glucose value\>153 mg/dl. **Measure:** Oral Glucose Tolerance Testing (OGTT) **Time Frame:** 15 minutes **Description:** It is evaluation of the sleep quality. There are 24 questions in all, 18 of which are used to determine the score. Subjective sleep quality, sleep latency, duration, habitual sleep efficiency, sleep disruptions, usage of sleeping pills, and dysfunction throughout the day are its seven constituent parts. The PSQI score is determined by assigning a point value between 0 and 3. A cumulative score of more than five indicates that the quality of sleep was inadequate. The score goes from 0 to 21. **Measure:** The Pittsburgh Sleep Quality Index **Time Frame:** 10 minutes ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * being between the ages of 18-40, * having a singleton pregnancy, being in the second trimester, * not having any known chronic disease. Exclusion Criteria: * working night shifts, * having a high-risk pregnancy, * having a neurological or orthopedic disease. **Healthy Volunteers:** True **Maximum Age:** 40 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Istanbul Medipol University #### Overall Officials **Official 1:** **Affiliation:** Medipol University **Name:** MERVE YILMAZ MENEK, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** There is no a plan to make individual participant data (IPD) **IPD Sharing:** NO ### References Module #### References **Citation:** Cassidy EM, Bailey CP, Napolitano MA, Vyas AN. Sleep duration and chronotype of pregnant women in the United States: An online cross-sectional survey study. Prev Med Rep. 2022 Dec 6;31:102088. doi: 10.1016/j.pmedr.2022.102088. eCollection 2023 Feb. **PMID:** 36820370 #### See Also Links **Label:** Sleep duration and chronotype of pregnant women in the United States: An online cross-sectional survey study. **URL:** https://pubmed.ncbi.nlm.nih.gov/36820370/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14127 - Name: Pregnancy Complications - Relevance: HIGH - As Found: Pregnancy Complications - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011248 - Term: Pregnancy Complications ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413771 **Brief Title:** Only Gonadotropin Vs. Letrozole Combined Gonadotropin Stimulation in IUI Cycles **Official Title:** Comparison of Two Ovarian Stimulation Strategies in Intrauterine Insemination Cycles of Couples With Unexplained Infertility; Only Gonadotropin Vs. Letrozole Combined Gonadotropin Stimulation. A Randomized Controlled Trial. #### Organization Study ID Info **ID:** 2022-4/39 #### Organization **Class:** OTHER **Full Name:** Uludag University ### Status Module #### Completion Date **Date:** 2024-02-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-01-01 **Type:** ACTUAL #### Start Date **Date:** 2023-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Uludag University #### Responsible Party **Investigator Affiliation:** Uludag University **Investigator Full Name:** GÜRKAN UNCU,PROF. MD **Investigator Title:** Prof. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The present randomized controlled study aims to investigate the effectiveness of a combined regimen of letrozole and gonadotropin with dose adjustments based on body mass index (BMI) compared to a conventional only gonadotropin regimen in intrauterine insemination (IUI) cycles for couples experiencing unexplained infertility. The study was conducted at a tertiary university hospital's Assisted Reproductive Technologies (ART) center from January 2023 to January 2024. Couples with unexplained infertility were enrolled based on comprehensive assessments, and randomization was performed based on national ID (odd or even). The Conventional Only Gonadotropin (COG) group received recombinant FSH based on body mass index (BMI), while the Combined Letrozole-Gonadotropin (CLG) group received letrozole followed by gonadotropin with dose adjustments based on BMI. Ovulation induction and IUI were performed according to standard protocols. Clinical outcomes, gonadotropin consumption, and pregnancy rates were compared between groups. Among 317 IUI cycles, 131 couples with unexplained infertility were randomized (CLG: 61, COG: 70). Demographic parameters were similar between groups. The CLG group had lower daily gonadotropin doses (67 ± 18 IU/D vs. 76 ± 11 IU/d, p=0.01) and total gonadotropin consumption (750 IU vs. 825 IU, p=0.01) with comparable ovulation and clinical pregnancy rates. The COG group exhibited higher multiple pregnancy rates, although not statistically significant (CLG vs. COG; 1/61 vs. 3/70, p=0.4). The study suggests that the combined letrozole and gonadotropin regimen with BMI-based dose adjustments in IUI cycles for unexplained infertility is associated with reduced gonadotropin consumption and potentially lower multiple pregnancy rates. ### Conditions Module **Conditions:** - Infertility Unexplained **Keywords:** - unexplained infertility - letrozole - gonadotropin - intrauterine insemination ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Masking Description:** Patients were divided into two study arms based on the initial digits of their national IDs by ART nurses. Importantly, the IVF clinicians remained blinded to the patients' grouping throughout the study. **Who Masked:** - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 131 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The Conventional Only Gonadotropin (COG) group received recombinant FSH based on body mass index (BMI) **Intervention Names:** - Drug: Gonadotropin **Label:** Conventional Only Gonadotropin **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** The combined Letrozole-Gonadotropin (CLG) group received letrozole followed by gonadotropin with dose adjustments based on BMI. **Intervention Names:** - Drug: Letrozole 2.5mg **Label:** Combined Letrozole-Gonadotropin group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Combined Letrozole-Gonadotropin group **Description:** Letrozole pretreatment during ovarian stimulation with gonadotropins, in intrauterine insemination cycles. **Name:** Letrozole 2.5mg **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Conventional Only Gonadotropin **Description:** Ovarian stimulation with gonadotropins, in intrauterine insemination cycles. **Name:** Gonadotropin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Presence of gestational sac by transvaginal ultrasound **Measure:** Clinical Pregnancy Rate **Time Frame:** 6 weeks #### Secondary Outcomes **Description:** Presence of multipl gestational sacs by transvaginal ultrasound **Measure:** Multiple Pregnancy Rate **Time Frame:** 6 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Couples with unexplained infertility * Aged between 18-35 Exclusion Criteria: * Male factor infertility * Diminished ovarian reserve * Patient refusion to participate **Maximum Age:** 35 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bursa **Country:** Turkey **Facility:** Uludag University Faculty of Medicine **State:** Gorukle **Zip:** 16085 #### Overall Officials **Official 1:** **Affiliation:** Uludag University **Name:** Gurkan Uncu, Prof. **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Description:** All data generated or analyzed during this study are included in this published article and are available from the corresponding author on reasonable request. **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10290 - Name: Infertility - Relevance: HIGH - As Found: Infertility - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007246 - Term: Infertility ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000047072 - Term: Aromatase Inhibitors - ID: D000065088 - Term: Steroid Synthesis Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000004965 - Term: Estrogen Antagonists - ID: D000006727 - Term: Hormone Antagonists - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1743 - Name: Letrozole - Relevance: HIGH - As Found: Visual - ID: M25769 - Name: Aromatase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M8116 - Name: Estrogens - Relevance: LOW - As Found: Unknown - ID: M8114 - Name: Estrogen Antagonists - Relevance: LOW - As Found: Unknown - ID: M30483 - Name: Estrogen Receptor Antagonists - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077289 - Term: Letrozole ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413758 **Brief Title:** Attentional Focus in Virtual Reality **Official Title:** Effect of Internal and External Focus on Balance Performance: Comparison of Virtual Reality and Real World Environment #### Organization Study ID Info **ID:** 06052024 #### Organization **Class:** OTHER **Full Name:** Istanbul University - Cerrahpasa (IUC) ### Status Module #### Completion Date **Date:** 2024-07-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Istanbul University - Cerrahpasa (IUC) #### Responsible Party **Investigator Affiliation:** Istanbul University - Cerrahpasa (IUC) **Investigator Full Name:** Aybike Senel **Investigator Title:** Research assistant, PT, PhD(c) **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 explorative observational study is to learn about the effect of internal and external focus on postural control in virtual reality and compare with the real world environment in young adults. The main question it aims to answer is: Does attentional focus effect differently on postural control in virtual reality comparing to real world environment? **Detailed Description:** Virtual Reality is used to improve postural control in various populations. However, exercise with virtual reality glasses cause new challenges to the user in maintaining balance. In this study, the effect of internal and external focus on postural control in the virtual reality environment will be revealed and compared with the performance in the real environment. The results of the study will guide the customization and optimization of balance training programs implemented in the virtual reality environment. A total of 38 healthy young adults will be included and allocated into Group I (Virtual Reality) or Group II (Real World) (ratio 1:1). The balance performance of the participants will be assessed with single leg stance test and bipodal stance test. The participants will be instructed to stand still and maintain balance on the forceplate in three conditions: (1) with an internal focus, (2) with an external focus, and (3) non-directional. Conditions will be applied to the participants randomly to avoid bias. Each condition will be measured three times and the mean values will be recorded as outcomes. The total displacement of center of pressure (CoP), the mean velocity of CoP, the CoP area, total mediolateral (ML) displacement, the mean velocity in ML, total anteroposterior (AP) displacement and the mean velocity in AP will assessed with K-Force Plates (Kinvent, France). ### Conditions Module **Conditions:** - Attentional Focus in Virtual Reality **Keywords:** - Postural Control - Virtual Reality - Focus of Attention ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 38 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In this group, participants will be in a virtual environment with a VR glass put on. The balance performance of the participants will be assessed with single leg stance test and bipodal stance test. The participants will be instructed to stand still and maintain balance on the forceplate in three conditions: (1) with an internal focus, (2) with an external focus, and (3) non-directional. Conditions will be applied to the participants randomly to avoid bias. Each condition will be measured three times and the mean values will be recorded as outcomes. The total displacement of center of pressure (CoP), the mean velocity of CoP, the CoP area, total mediolateral (ML) displacement, the mean velocity in ML, total anteroposterior (AP) displacement and the mean velocity in AP will assessed with K-Force Plates (Kinvent, France). **Label:** Group I-Virtual Reality #### Arm Group 2 **Description:** The balance performance of the participants will be assessed with single leg stance test and bipodal stance test. The participants will be instructed to stand still and maintain balance on the forceplate in three conditions: (1) with an internal focus, (2) with an external focus, and (3) non-directional. Conditions will be applied to the participants randomly to avoid bias. Each condition will be measured three times and the mean values will be recorded as outcomes. The total displacement of center of pressure (CoP), the mean velocity of CoP, the CoP area, total mediolateral (ML) displacement, the mean velocity in ML, total anteroposterior (AP) displacement and the mean velocity in AP will assessed with K-Force Plates (Kinvent, France). **Label:** Group II-Real World ### Outcomes Module #### Primary Outcomes **Description:** Total displacement of center of pressure on the force plate **Measure:** Total displacement of center of pressure **Time Frame:** baseline **Description:** the mean velocity of center of pressure on the force plate **Measure:** The mean velocity of center of pressure **Time Frame:** baseline **Description:** the area drawn by the movement of center of pressure on the force plate **Measure:** The area of center of pressure **Time Frame:** baseline **Description:** total mediolateral displacement of center of pressure on the force plate **Measure:** total mediolateral displacement **Time Frame:** baseline **Description:** total anterolateral displacement of center of pressure on the force plate **Measure:** total anterolateral displacement **Time Frame:** baseline **Description:** the mean velocity of total mediolateral displacement of center of pressure on the force plate **Measure:** the mean velocity in mediolateral **Time Frame:** baseline **Description:** the mean velocity of total anterolateral displacement of center of pressure on the force plate **Measure:** the mean velocity in anterolateral **Time Frame:** baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Being a healthy individual between the ages of 18-26 * Lower extremity functional motor signs or sensory features should be normal or corrected * No lower extremity injury within 6 months * Not taking alcohol or medication 12 hours before * Having no virtual reality experience Exclusion Criteria: * History of epilepsy, marked dissociative seizures * Needing assistive devices to maintain upright posture * Other comorbidities that may affect postural control (dizziness, vestibular disorders, orthopedic or cardiovascular comorbidities) * Being an athlete * Positive Fukuda stepping test **Maximum Age:** 26 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** healthy young adults between the ages of 18-26 ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Aybikesenel@hotmail.com **Name:** Aybike Şenel, PT, MSc **Phone:** 05315839924 **Role:** CONTACT ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M4854 - Name: Benzocaine - Relevance: LOW - As Found: Unknown - ID: T433 - Name: Tannic Acid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413745 **Brief Title:** Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer **Official Title:** A Phase II Clinical Study of SHR-A1811 in Patients With HER2-expressing/Amplified, Locally Advanced, Unresectable or Metastatic Biliary Tract Cancer (BTC) Who Have Previously Failed First or Second-line Systemic Therapy #### Organization Study ID Info **ID:** SHR-A1811-212 #### Organization **Class:** INDUSTRY **Full Name:** Jiangsu HengRui Medicine Co., Ltd. ### Status Module #### Completion Date **Date:** 2025-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Jiangsu HengRui Medicine Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study was to evaluate the efficacy and safety of SHR-A1811 in patients with locally advanced unresectable or recurrent metastatic BTC with HER2 expression / amplification who failed first-line or second-line systemic treatment. ### Conditions Module **Conditions:** - HER2 Expression / Amplification in Patients With Biliary Tract Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 65 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: SHR-A1811 **Label:** SHR-A1811 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - SHR-A1811 **Description:** SHR-A1811 **Name:** SHR-A1811 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** ORR evaluated by IRC according to RECIST v1.1 standard **Time Frame:** About a year #### Secondary Outcomes **Measure:** DoR evaluated by IRC according to RECIST v1.1 standard **Time Frame:** About a year **Measure:** DCR evaluated by IRC according to RECIST v1.1 standard **Time Frame:** About a year **Measure:** PFS evaluated by IRC according to RECIST v1.1 standard **Time Frame:** About a year **Measure:** ORR evaluated by the researchers according to the RECIST v1.1 standard **Time Frame:** About a year **Measure:** DCR evaluated by the researchers according to the RECIST v1.1 standard **Time Frame:** About a year **Measure:** DoR evaluated by the researchers according to the RECIST v1.1 standard **Time Frame:** About a year **Measure:** PFS evaluated by the researchers according to the RECIST v1.1 standard **Time Frame:** About a year **Measure:** OS **Time Frame:** About two year **Measure:** AE **Time Frame:** About a year **Measure:** SAE **Time Frame:** About a year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age 18-75 years old ( including both ends ), male or female ; 2. ECOG-PS score : 0 or 1; 3. Expected survival ≥ 12 weeks; 4. Subjects with locally advanced or recurrent metastatic biliary tract cancer diagnosed by histopathology or cytology are not suitable for surgical resection, transplantation or ablation; 5. Subjects who failed or intolerance after systemic chemotherapies; 6. According to the RECIST v1.1 standard, the subjects had at least one measurable lesion； 7. The main organ function is normal, in line with the program requirements ; 8. If the patient has active hepatitis B virus ( HBV ) infection : HBV-DNA must be \< 500 IU / mL； 9. Consent to contraception. Exclusion Criteria: 1. Received anti-tumor treatment such as chemotherapy, radiotherapy, immunotherapy, biotherapy or other clinical research drugs within 4 weeks before the first administration; 2. Subjects with a history or evidence of brain metastasis or meningeal metastasis ; 3. With acute or chronic uncontrolled pancreatitis or Child-Pugh liver function grade C ; 4. Severe trauma or major surgery was performed within 4 weeks before the first administration; 5. To study the severe heart disease within 6 months before the first administration ; 6. Patients with clinical symptoms and uncontrolled moderate and above pleural effusion, ascites or pericardial effusion, requiring therapeutic puncture drainage ; 7. Severe infection symptoms occurred within 2 weeks before the first administration; 8. Known hereditary or acquired bleeding and thrombotic tendency ; 9. Congenital or acquired immune defects; 10. The subjects had severe and uncontrollable concomitant diseases; 11. Cerebral infarction, pulmonary embolism or deep vein thrombosis occurred within 6 months before the first administration of the study; **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Shiwei.sun@hengrui.com **Name:** Shiwei Sun **Phone:** +86 18036618554 **Role:** CONTACT #### Locations **Location 1:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Name:** Jia Fan - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** Zhongshan Hospital，Fudan University **State:** Shanghai **Zip:** 200032 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001660 - Term: Biliary Tract Diseases - ID: D000004066 - Term: Digestive System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M4947 - Name: Biliary Tract Neoplasms - Relevance: HIGH - As Found: Biliary Tract Cancer - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M4946 - Name: Biliary Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: T761 - Name: Biliary Tract Cancer - Relevance: HIGH - As Found: Biliary Tract Cancer ### Condition Browse Module - Meshes - ID: D000001661 - Term: Biliary Tract Neoplasms ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06413732 **Brief Title:** The Effect of Dual Task Training in Patients With Stroke **Official Title:** The Effect of Dual Task Training on Gait, Balance, and Quality of Life in Patients With Stroke #### Organization Study ID Info **ID:** Karabuk Physiotherapy #### Organization **Class:** OTHER **Full Name:** Karabuk University ### Status Module #### Completion Date **Date:** 2024-01-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-09 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-05-31 **Type:** ACTUAL #### Start Date **Date:** 2022-09-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-14 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Karabuk University #### Responsible Party **Investigator Affiliation:** Karabuk University **Investigator Full Name:** Tarik Ozmen **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of this study was to investigate the effect of dual-task training on gait, balance, and quality of life in individuals with stroke. The study included 30 individuals aged 30-80 years with stroke. All participants were assessed using the 10-meter walk test (10MWT), 10MWT under dual-task interaction (DTI), timed up and go (TUG), 30-Second Chair-Stand Test (30s-CST), Berg Balance Scale (BBS), Short Form 36 (SF-36). Participants were randomized into two groups. Both groups received conventional physiotherapy for approximately 1 hour, five days a week. Group I also received dual-task training. ### Conditions Module **Conditions:** - Stroke ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The dual-task training program combined with conventional physiotherapy was applied to both groups for approximately 1 hour, 5 days a week. **Intervention Names:** - Other: Conventional physiotherapy **Label:** Group I **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Only conventional physiotherapy was applied to both groups for approximately 1 hour, 5 days a week. **Intervention Names:** - Other: Conventional physiotherapy **Label:** Group II **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Group I - Group II **Description:** Conventional physiotherapy was applied for approximately 1 hour, 5 days a week. **Name:** Conventional physiotherapy **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** It is a scale designed to evaluate balance and determine the risk of falling. It consists of 14 items based on performance of sitting, standing, and posture change. Scores can range from 0 to 56. The higher the score, the better the postural control. **Measure:** Berg Balance Scale **Time Frame:** Six weeks **Description:** The participant was asked to get up from the chair he was sitting on, walk 3 meters at a safe and normal speed, and then turn back and sit on the chair again. The time was recorded by a stopwatch. **Measure:** Timed Up and Go Test **Time Frame:** Six weeks **Description:** The 10-meter walk test (10MWT) is suggested for assessing gait in post-stroke rehabilitation. The participant was instructed to walk at comfortable walking speed a distance of 10 meters. The time was recorded in seconds with a stopwatch. **Measure:** 10-meter walk test **Time Frame:** Six weeks **Description:** For this test, the participant was seated on a chair with a sitting height of 45-47 cm, with his arms on his chest, and was asked to stand up and sit down as many times as possible within 30 seconds. The score was recorded as zero if the participant could not get up from the chair without using their arms **Measure:** 30-Second Chair-Stand Test **Time Frame:** Six weeks **Description:** The scale consists of 36 items in the following categories: physical function, social function, physical role, emotional role, mental health, vitality, bodily pain, and general health. Subscales evaluate health between 0 and 100, with 0 indicating poor health and 100 indicating good health. The scale consists of 36 items in the following categories: physical function, social function, physical role, emotional role, mental health, vitality, bodily pain, and general health. Subscales evaluate health between 0 and 100, with 0 indicating poor health and 100 indicating good health. The scale consists of 36 items in the following categories: physical function, social function, physical role, emotional role, mental health, vitality, bodily pain, and general health. Subscales evaluate health between 0 and 100, with 0 indicating poor health and 100 indicating good health. **Measure:** Short Form 36 **Time Frame:** Six weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Having a score of 24 or above on the Mini-Mental State Test, * Being able to walk at least 10 meters without using a walking aid * Having a total score of 5 on the motor and cognitive sections of the Functional Independence Scale. Exclusion Criteria: * Neurological and orthopedic problems that could affect motor performance and balance * Communication problems * Patients who had received Botulinum Toxin injection treatment in the last six months **Maximum Age:** 80 Years **Minimum Age:** 30 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Karabuk **Country:** Turkey **Facility:** Tarik Ozmen **Zip:** 78050 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002561 - Term: Cerebrovascular Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M22306 - Name: Stroke - Relevance: HIGH - As Found: Stroke - ID: M5810 - Name: Cerebrovascular Disorders - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000020521 - Term: Stroke ### Misc Info Module - Version Holder: 2024-05-31