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<|newrecord|> nctId: NCT06387459 id: 2022M3C1A3090827 briefTitle: Feasibility of Fabric Orthosis for Knee Support in Elderly Gait Improvement overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-05-14 date: 2026-05-14 date: 2024-04-29 date: 2024-04-29 name: Seoul National University Hospital class: OTHER name: Ministry of Science and ICT briefSummary: This pilot clinical trial assesses the safety and feasibility of a novel fabric-type orthosis designed to mimic the knee extensor muscles and improve gait in elderly patients with mobility impairments due to conditions like sarcopenia, diabetes, or knee osteoarthritis. The study aims to test this orthosis in a real- world setting to see if it can enhance mobility and stability for elderly individuals, potentially reducing falls and improving quality of life. A total of 30 participants aged 65 and older will be recruited to use this orthosis across multiple sessions, where their gait will be analyzed under various conditions to measure the device's impact on walking speed, stability, and muscle activation. conditions: Gait conditions: Fall conditions: Orthotic Devices studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: Fabric-Type Knee Extensor Muscle-Mimicking Orthosis measure: Completion Rate measure: Dropout Rate measure: User Feedback measure: 6-Minute Walk Test measure: 10-Meter Walk Test measure: Surface Electromyography measure: Gait Analysis sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06387446 id: RB-P00044611 briefTitle: Allogeneic Valve Transplantation overallStatus: RECRUITING date: 2024-05-01 date: 2027-06-01 date: 2027-06-01 date: 2024-04-29 date: 2024-04-29 name: Boston Children's Hospital class: OTHER briefSummary: Valves will be taken from hearts donated by organ donors, and implanted into patients who need a new heart valve. conditions: Valve Heart Disease conditions: Valve Disease, Heart conditions: Valve Disease, Aortic studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 4 type: ESTIMATED name: Valve transplant measure: Valve Regurgitation measure: Valve Annulus Growth measure: Leaflet Growth measure: Ventricular Function measure: Survival sex: ALL minimumAge: 30 Days maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Boston Children's Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States name: Sitaram Emani, MD role: CONTACT lat: 42.35843 lon: -71.05977 hasResults: False
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<|newrecord|> nctId: NCT06387433 id: mHealth id: SG-222/R3-05/RDC/DUHS/1478 type: OTHER_GRANT domain: National Institutes of Health Pakistan briefTitle: Effectiveness of an mHealth Mobile App acronym: mHealth overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-20 date: 2025-08 date: 2025-08 date: 2024-04-29 date: 2024-04-29 name: Dow University of Health Sciences class: OTHER name: National Institutes of Health (NIH) briefSummary: Type II diabetes is a serious challenge for Pakistan. Not using medications properly increases healthcare costs and diabetes-related deaths. A mobile app in local language can improve medication adherence and self-management among diabetics. Therefore, in this 18 months long study we will develop a diabetes-related mobile application in Urdu, and will conduct a trial to assess whether it improves medication compliance and self-management, and how much economical this app would be compared to the usual standard of care for type II diabetics in Pakistan. This trial will be conducted at the National Institute of Diabetes and Endocrinology Karachi. The study participants will be divided in two groups. Only one group will use this application. We will measure medication compliance and self-management through diabetes-specific blood test and self-reporting questionnaires between two groups. We will also determine how much economic costs would be saved by using this app to improve medication compliance conditions: Type II Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 160 type: ESTIMATED name: mobile app use measure: adherence to medication measure: self-management among diabetics measure: Intervention usability measure: economic effectiveness of the app sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institute of Diabetes and Endocrinology city: Karachi state: Sindh country: Pakistan lat: 24.8608 lon: 67.0104 hasResults: False
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<|newrecord|> nctId: NCT06387420 id: AK117-206 briefTitle: A Study of AK117 in Combination With Azactidine Plus Venetoclax in Patients With Acute Myeloid Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2026-04 date: 2027-04 date: 2024-04-29 date: 2024-04-29 name: Akeso class: INDUSTRY briefSummary: This is a phase 1b/2 study. All patients are diagnosed with Acute Myeloid Leukemia (AML), Eastern Cooperative Oncology Group (ECOG) performance status 0-3. The purpose of this study is to evaluate the safety and efficacy of AK117 + azacitidine + venetoclax in subjects with AML. conditions: ACUTE MYELOID LEUKEMIA; AML studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: AK117 name: Azacitidine name: Venetoclax name: Placebo measure: Phase 1b: Number of participants with dose limiting toxicity (DLT) measure: Phase 1b/2: Number of participants with adverse events (AEs) measure: Phase 1b/2: Composite complete remission rate (CCR) measure: Overall response rate (ORR) measure: Time to response (TTR) measure: Time to CCR (TTCCR) measure: Duration of response (DoR) measure: Duration of CCR (DoCCR) measure: Rate of CCR Without Minimal Residual Disease (CCR MRD-) measure: Event-free survival (EFS) measure: Overall survival (OS) measure: Peak of Serum Concentration (Cmax) measure: Anti-drug antibody (ADA) measure: Receptor occupancy (RO) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College city: Tianjin country: China name: Jianxiang Wang role: CONTACT lat: 39.14222 lon: 117.17667 hasResults: False
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<|newrecord|> nctId: NCT06387407 id: 2024037K briefTitle: Population Pharmacokinetic Study of the Effect of Polymorphisms in the ABCB1 and CES1 Genes on the Pharmacokinetics of Dabigatran overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-06-10 date: 2025-11-25 date: 2024-04-29 date: 2024-04-29 name: The Affiliated Hospital Of Guizhou Medical University class: OTHER briefSummary: According to published studies, the effects of genetic polymorphisms in the ABCB1 and CES1 genes on the blood concentration of dabigatran are controversial, and it is not clear whether dabigatran dosage and dosing intervals need to be adjusted according to genotype or other covariates in Chinese subjects. For these purposes, we will include patient demographics, genetic polymorphisms, and PK data based on a population pharmacokinetic study of dabigatran ester in healthy Chinese subjects to analyze the effect on dabigatran pharmacokinetics.
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The aim of this study was to develop a population pharmacokinetic model to understand the relationship between dabigatran-related genes and dabigatran plasma levels after a single oral dose in healthy Chinese subjects and patients, and to analyze the effects of genetic variation on the efficacy and safety of dabigatran etexilate. conditions: Combined Analysis of Polymorphisms and Dabigatran Pharmacokinetic Parameters studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 30 type: ESTIMATED name: Dabigatran Etexilate 150mg measure: Plasma drug concentration sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06387394 id: M21-416 briefTitle: A Study to Assess BOTOX Injections in Adult Participants for the Change of Masseter Muscle Prominence overallStatus: RECRUITING date: 2024-04-22 date: 2025-12-27 date: 2026-01-26 date: 2024-04-29 date: 2024-04-29 name: AbbVie class: INDUSTRY briefSummary: The masseter muscle is one of the muscles in the lower face used for chewing. The prominence of the masseter muscle can appear as a widened lower face which some individuals deem as aesthetically undesirable and can be treated by selectively weakening the masseter muscles with small quantities of botulinum toxin. The purpose of this study is to assess how safe and effective injection of onabotulinumtoxinA (BOTOX) is in adult participants with Masseter Muscle Prominence (MMP).
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BOTOX is being investigated for the treatment of Muscle Masseter Prominence. In Period 1, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment, placebo or BOTOX. There is a 1 in 4 chance that participants will be assigned to placebo. In Period 2, eligible participants can receive an optional open-label retreatment of BOTOX. Approximately 200 adult participants with MMP will be enrolled in the study at approximately 20 sites in the United States.
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Participants will receive intramuscular injections across both the right and left masseter muscle of either BOTOX or placebo on Day 1. Participants who are eligible for re-treatment will be given BOTOX injections on either the Day 180, 210, 240, or 270 visit and will be followed up for up to 6 months.
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There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects, and completing questionnaires. conditions: Masseter Muscle Prominence studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: BOTOX name: Placebo measure: Composite Achievement of MMP Severity Improvement and at Least a 2-Grade Improvement from Baseline by Both Investigator-Rated MMPS and Participant-Rated MMPS-P measure: Number of Participants with Adverse Events (AEs) measure: Percentage of Participants Achieving Investigator-Rated MMPS Improvement Over Time measure: Percentage of Participants Achieving Participant-Rated MMPS-P Improvement Over Time measure: Percentage of Participants who Responded as "Very satisfied" or "Satisfied" on the Lower Facial Shape Questionnaire - Treatment Satisfaction Assessment (LFSQ-TXSAT) measure: Percentage of Participants who Responded as "Much improved" or "Moderately improved" on the MMP Participant Self-Assessment of Change (MMP-PSAC) measure: Percentage of Participants who Responded as "Not at all bothered" or "A little bothered" on the Bother Impact Assessment for Masseter Muscle Prominence (BIA-MMP) measure: Change from Baseline in Lower Facial Shape Questionnaire-Impact Assessment (LFSQ-IA) Summary Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Delricht Research /ID# 249825 status: RECRUITING city: New Orleans state: Louisiana zip: 70115 country: United States lat: 29.95465 lon: -90.07507 facility: Clarkston Dermatology /ID# 248888 status: RECRUITING city: Clarkston state: Michigan zip: 48346 country: United States lat: 42.73586 lon: -83.41883 hasResults: False
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<|newrecord|> nctId: NCT06387381 id: CYYY-KY-2024-048-01 briefTitle: 68Ga-PSFA PET Imaging in Patients With PSMA/FAP Positive Disease overallStatus: RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2026-12-31 date: 2024-04-29 date: 2024-04-29 name: First Affiliated Hospital of Chongqing Medical University class: OTHER briefSummary: As a new dual receptor (PSMA and FAP) targeting PET radiotracer, 68Ga-PSFA is promising as an excellent imaging agent applicable to PSMA/FAP positive diseases. In this research, we investigate the safety, biodistribution and potential usefulness of 68Ga-PSFA positron emission tomography (PET) for the diagnosis of lesions in PSMA/FAP positive diseases. conditions: PSMA conditions: FAP conditions: Positron-Emission Tomography studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ESTIMATED name: 68Ga-PSFA measure: Diagnostic efficacy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Chongqing Medical University status: RECRUITING city: Chongqing state: Chongqing zip: 400016 country: China name: Xiaoyang Zhang, PhD role: CONTACT phone: 023-89011755 email: [email protected] lat: 29.56278 lon: 106.55278 hasResults: False
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<|newrecord|> nctId: NCT06387368 id: HE-202303 briefTitle: Clinical Study of Huaier Granule in the Treatment of Unresectable Pancreatic Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-03 date: 2028-08 date: 2024-04-29 date: 2024-04-29 name: Health Science Center of Xi'an Jiaotong University class: OTHER name: LinkDoc Technology (Beijing) Co. Ltd. name: Huazhong University of Science and Technology briefSummary: This is a prospective, multicenter, randomized, open, parallel controlled clinical study to evaluate the efficacy and safety of Huaier Granules combined with capecitabine in the treatment of unresectable pancreatic cancer. conditions: Pancreatic Cancer Non-resectable studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 488 type: ESTIMATED name: Huaier Granule name: Capecitabine measure: Overall survival measure: Objective response rate measure: Progression free survival measure: Conversion surgery rate measure: The incidence and severity of adverse events (AE) and severe adverse events (SAE) measure: The incidence and severity of ADR, severe adverse reactions (SADR), suspicious and unexpected severe adverse reactions (SUSAR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06387355 id: SURG-006-23S briefTitle: Diagnosis and Treatment of CAD in Severe PAD After Lower Extremity Revascularization acronym: CAD in sPAD overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2027-08-01 date: 2029-08-01 date: 2024-04-29 date: 2024-04-29 name: VA Office of Research and Development class: FED briefSummary: Peripheral artery disease, lack or blood flow to the legs, has a high prevalence in the Veteran population. In patients with severe peripheral artery disease that requires an endovascular or surgical intervention for lower leg revascularization, the long-term mortality of approximately 50% is worse that most cancers. The goal of this study is to develop a management strategy to improve cardiovascular outcomes in this high-risk peripheral artery disease population after lower extremity revascularization. conditions: Peripheral Artery Disease conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This will be a parallel interventional model to assign participants to a treatment strategy in a clinical study primaryPurpose: TREATMENT masking: NONE count: 450 type: ESTIMATED name: Coronary computed topography (CT) angiography with FFR-CT measure: Major adverse cardiovascular events (MACE) measure: Cardiovascular-related death measure: Myocardioal infarction measure: All-cause mortality measure: Amputation-free survival sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rocky Mountain Regional VA Medical Center, Aurora, CO city: Aurora state: Colorado zip: 80045 country: United States name: Clay Quint, MD PhD role: CONTACT phone: 210-606-2940 email: [email protected] name: Clay Quint, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 facility: North Florida/South Georgia Veterans Health System, Gainesville, FL city: Gainesville state: Florida zip: 32608-1135 country: United States name: Salvatore Scali, MD role: CONTACT phone: 352-376-1611 lat: 29.65163 lon: -82.32483 facility: Louis Stokes VA Medical Center, Cleveland, OH city: Cleveland state: Ohio zip: 44106-1702 country: United States name: Michael Rosenbaum, MD role: CONTACT phone: 216-791-3800 lat: 41.4995 lon: -81.69541 facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA city: Pittsburgh state: Pennsylvania zip: 15240 country: United States name: Edith Tzeng, MD role: CONTACT phone: 866-482-7488 lat: 40.44062 lon: -79.99589 facility: Tennessee Valley Healthcare System Nashville Campus, Nashville, TN city: Nashville state: Tennessee zip: 37212-2637 country: United States name: John Curci, MD role: CONTACT phone: 615-327-4751 lat: 36.16589 lon: -86.78444 facility: VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX city: Dallas state: Texas zip: 75216-7167 country: United States name: Shirling Tsai, MD role: CONTACT phone: 469-797-2100 lat: 32.78306 lon: -96.80667 facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA city: Seattle state: Washington zip: 98108-1532 country: United States name: Gale Tang, MD role: CONTACT phone: 800-329-8387 lat: 47.60621 lon: -122.33207 hasResults: False
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<|newrecord|> nctId: NCT06387342 id: CF102-222PC briefTitle: Namodenoson Treatment of Advanced Pancreatic Cancer overallStatus: NOT_YET_RECRUITING date: 2024-07-15 date: 2026-07-15 date: 2026-12-15 date: 2024-04-29 date: 2024-04-29 name: Can-Fite BioPharma class: INDUSTRY briefSummary: This is an open-label trial in patients with advanced pancreatic cancer. The trial will evaluate the safety, clinical activity, and pharmacokinetics of the study drug, namodenoson, in this group of patients. conditions: Pancreatic Adenocarcinoma conditions: Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Open-label study primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Namodenoson 25mg measure: Adverse Events measure: Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Change from baseline measure: Objective response rate measure: Progression free survival measure: Disease control rate measure: Duration of response measure: Overall survival measure: Quality of Life evaluation with EORTC QLQ-C30 measure: Quality of Life evaluation with EORTC QLQ-PAN26 measure: Pharmacokinetics of namodenoson: Cmax measure: Pharmacokinetics of namodenoson: Cmin measure: Pharmacokinetics of namodenoson: AUC(0-12) measure: Cancer antigen 19-9 (CA 19-9) measure: Carcinoembryonic Antigen (CEA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rabin Medical Center Institute of Oncology city: Petach Tikva zip: 49100 country: Israel name: Salomon M Stemmer, MD role: CONTACT lat: 32.08707 lon: 34.88747 hasResults: False
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<|newrecord|> nctId: NCT06387329 id: WRNMMC-2023-0438 briefTitle: Bladder Botox UTI Antibiotic Prophylaxis overallStatus: RECRUITING date: 2024-04-04 date: 2025-06-30 date: 2025-06-30 date: 2024-04-29 date: 2024-04-29 name: Walter Reed National Military Medical Center class: FED briefSummary: Overactive bladder (OAB) is a common condition with a prevalence of 17% in the general population that significantly affects quality of life. Intradetrusor onabotulinumtoxinA injections are an advanced therapy for OAB as well as interstitial cystitis/bladder pain syndrome (IC/BPS). The most common adverse event following intradetrusor injection of onabotulinumtoxinA in urinary tract infection (UTI), which occurs in 8.6-48.1% of patients. To prevent UTIs, patients are given a course of antibiotics, however the ideal prophylactic regimen has not been determined for the timing, duration, and type of antibiotic. Four retrospective studies in the literature address this question with variable conclusions, and there are no prospective studies. Identifying the ideal regimen is important for preventing UTIs as well as minimizing antibiotic use to prevent adverse effects and development of antibiotic resistance.
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The population to be studied will be female patients 18 years and older who are patients of the urogynecology and urology clinics at Walter Reed National Military Medical Center with a diagnosis of OAB or IC/BPS and have chosen to be treated with intradetrusor onabotulinumtoxinA injections. It will be a non-blinded randomized controlled noninferiority trial in which the patients are randomly placed into 2 groups. The first group will receive a 3 day course of twice daily oral nitrofurantoin 100mg starting at the time of the procedure, and the second group will receive a single dose of 100mg oral nitrofurantoin at the time of the procedure.
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The patients will be screened at the clinic at the time that they schedule their intradetrusor onabotulinumtoxinA injection appointment or by phone 1-2 weeks prior to their procedure. If the patient agrees to participate in the study then they will be instructed to give a urine sample for urinalysis and culture 1 week prior to the procedure appointment to exclude existing UTI. If a UTI is diagnosed at this time they must complete treatment prior to the procedure or will need to reschedule their procedure. On the day of the procedure patients will receive the clinic standard 10ml of 2% viscous lidocaine through the urethra 10-20 minutes prior to the procedure, and may be offered 5-10mg oral diazepam at the discretion of the treating physician. All patients will be given 200mg of phenazopyridine and 100mg of nitrofurantoin prior to the initiation of the procedure. The procedure will take place as directed by the treating physician per standard operating procedure.
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A urinalysis and urine culture will be placed for all study participants at time of their procedure appointment in case they have symptoms of UTI, and they will be instructed to follow up with the research team by phone if they have concerns for a UTI. Patients will be contacted 30-45 days after the procedure by phone, email, or message through genesis and asked about any UTI symptoms, UTI diagnoses and secondary outcomes during the 30 days following the procedure. Data will be analyzed for the primary outcome of UTI rates in the 30 days following intradetrusor onabotulinumtoxinA injection. conditions: Overactive Bladder conditions: Bladder Pain Syndrome studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Nonblinded, randomized, noninferiority trial of single dose nitrofurantoin vs 3 day twice daily course of nitrofurantoin for prevention of post-procedure urinary tract infections after intradetrusor onabotulinumtoxinA injections for OAB and IC/BPS. primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: Nitrofurantoin 100 MG measure: Urinary tract infection measure: Urinary tract infection symptoms measure: Urinary retention measure: Adverse effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Walter Reed National Military Medical Center status: RECRUITING city: Bethesda state: Maryland zip: 20899 country: United States name: Jordan Gisseman, MD role: CONTACT phone: 301-400-2468 email: [email protected] lat: 38.98067 lon: -77.10026 hasResults: False
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<|newrecord|> nctId: NCT06387316 id: 2023-1526 briefTitle: Cephalic Phase Responses to Nutritive and Non-Nutritive Sweeteners overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-26 date: 2024-04-17 date: 2025-03-30 date: 2024-04-29 date: 2024-04-29 name: Purdue University class: OTHER briefSummary: This study will focus on changes in blood sugar in response to tasting different types of sweeteners using continuous glucose monitoring (CGM) technology. conditions: Pre Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: solutions are coded whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: No Oral Stimulation name: Oral water stimulation name: Oral Salt Stimulation name: Oral Sucralose Stimulation name: Oral Sucrose stimulation measure: Blood glucose concentration sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Purdue University city: West Lafayette state: Indiana zip: 47907 country: United States lat: 40.42587 lon: -86.90807 hasResults: False
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<|newrecord|> nctId: NCT06387303 id: HSR230492 briefTitle: Pain Control and Quality of Recovery After Intravenous Methadone Versus Intrathecal Morphine in Major Abdominal Surgery overallStatus: NOT_YET_RECRUITING date: 2024-05-12 date: 2026-05-11 date: 2026-05-11 date: 2024-04-29 date: 2024-04-29 name: University of Virginia class: OTHER briefSummary: Moderate to severe postoperative pain is relatively common after major abdominal surgery and is associated with less than optimal surgical experience, poor quality of recovery, and development of persistent postsurgical pain. Opioids remain a major component of postoperative pain management. Side effects of opioids used for treatment of postoperative pain include constipation, pruritus, nausea, and vomiting.1,2 Enhanced recovery after surgery (ERAS) protocols involve utilization of multimodal analgesia. Analgesic techniques used include epidural analgesia, nerve blocks, and Intrathecal (IT) administration of morphine. IT morphine reduces postoperative opioid requirement for 18-24 hours after major abdominal surgery and reduces hospital length of stay (LOS) compared with epidural analgesia.3,4 Significant number of patients that receive IT morphine still experience moderate to severe postoperative pain.5 Additionally, many patients refuse the invasive procedure or cannot receive IT morphine due to procedure contraindications; thrombocytopenia and/or coagulopathy.6
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Intravenous (IV) methadone has a long analgesic half-life and has N-methyl-D-aspartate (NMDA) receptor antagonist and serotonin and norepinephrine reuptake inhibitor (SNRI) properties.7-9 It has previously been shown to reduce postoperative opioid requirements, postoperative nausea and vomiting (PONV), and postoperative pain scores in patients that underwent orthopedic, abdominal, complex spine, and cardiac surgery.10-13 Similar findings have been shown in obstetric patients that underwent caesarean delivery under general anesthesia as well as patients that underwent gynecologic surgery.14,15 IV methadone has, however, never been compared with IT morphine as a postoperative analgesic.
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Our hypothesis is that intravenous (IV) methadone is non-inferior to IT morphine in patients who undergo major abdominal surgery. It offers the advantage of being a noninvasive analgesic, modality that may contribute to decreasing opioid consumption during the first 72 hours postoperatively, controlling postoperative pain, and improving quality of recovery after surgery. conditions: Pain, Postoperative studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: a single blind study primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: PARTICIPANT count: 218 type: ESTIMATED name: Methadone name: Morphine measure: Quality of Recovery 15 score measure: Overall Benefits of Analgesic Score (OBAS) measure: morphine milligram equivalent measure: Verbal Rating Scale (VRS) pain scores measure: McGill Pain questionnaire score measure: Verbal Rating Scale (VRS) pain scores sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Virginia city: Charlottesville state: Virginia zip: 22908-0710 country: United States lat: 38.02931 lon: -78.47668 hasResults: False
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<|newrecord|> nctId: NCT06387290 id: 00172836 briefTitle: Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2030-05-01 date: 2030-05-01 date: 2024-04-29 date: 2024-04-29 name: University of Utah class: OTHER name: Rutgers University briefSummary: The primary aim of this implementation-effectiveness trial is to examine the effectiveness of Mindfulness-Oriented Recovery Enhancement (MORE) and patient-centered chronic pain management visits in primary care as interventions to reduce chronic pain, improve quality of life, and reduce opioid-related harms among chronic pain patients on long-term opioid therapy. conditions: Chronic Pain conditions: Prescription Opioid Misuse conditions: Substance-Related Disorders conditions: Pain conditions: Narcotic-Related Disorders conditions: Chemically-Induced Disorders conditions: Mental Disorders conditions: Opioid-Related Disorders conditions: Neurologic Manifestations studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Hybrid implementation-effectiveness trial primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Investigators, study staff, and statistician will be blinded to treatment condition. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Mindfulness Oriented Recovery Enhancement name: Patient-Centered Chronic Pain Management Visits measure: Opioid Misuse measure: Chronic Pain measure: Change in Quality of Life measure: Opioid Dosing measure: Opioid Craving measure: PTSD Symptoms measure: Depression measure: Generalized Anxiety measure: Decentering measure: Mindful Reappraisal of Pain Sensations measure: Savoring measure: Reappraisal sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rutgers University Primary Care Clinics city: New Brunswick state: New Jersey zip: 08901 country: United States name: Thanusha Puvananayagam, MPH role: CONTACT phone: 732-235-4341 email: [email protected] name: Taylor Scott, MSW role: CONTACT phone: 732-235-7453 email: [email protected] name: Nina Cooperman, PsyD role: PRINCIPAL_INVESTIGATOR lat: 40.48622 lon: -74.45182 facility: University of Utah Primary Care Clinics city: Salt Lake City state: Utah zip: 84112 country: United States name: Kelly A Hendrickson, MS role: CONTACT phone: 801-585-6354 email: [email protected] name: Layla Lincoln, BA role: CONTACT phone: 801-581-7508 email: [email protected] name: Eric L Garland, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.76078 lon: -111.89105 hasResults: False
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<|newrecord|> nctId: NCT06387277 id: RV1551P20220376 briefTitle: Re-epithelialization Efficacy Evaluation of Cosmetic Product RV1551P vs Non-treated Forearm of Healthy Adult Women overallStatus: COMPLETED date: 2022-09-19 date: 2022-12-12 date: 2022-12-12 date: 2024-04-29 date: 2024-04-29 name: Pierre Fabre Dermo Cosmetique class: INDUSTRY briefSummary: The aim of this study was to evaluate the impact of the product RV1551P GB3224 on skin microbiota during wound healing process, based on swab samples collected from lesion areas using an epidermally ablated skin model of erbium YAG laser. conditions: Healthy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 21 type: ACTUAL name: RV1551P GB3224 measure: Time to re-epithelialization as assessed by in vivo examination by the investigator and standardized photographs taken with a C Cube Camera® measure: Skin microbiota diversity from swab samples. measure: Skin microbiota composition from swab samples. measure: Metabolomic analysis from swab samples sex: FEMALE minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT facility: Skin Research Centre city: Toulouse state: Haute-Garonne zip: 31300 country: France lat: 43.60426 lon: 1.44367 hasResults: False
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<|newrecord|> nctId: NCT06387264 id: 2022PHC032 briefTitle: Compont - Varicose Veins of the Lower Extremities overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-11 date: 2024-04 date: 2024-12 date: 2024-04-29 date: 2024-04-29 name: Peking University People's Hospital class: OTHER name: Peking University First Hospital name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine name: First Affiliated Hospital Xi'an Jiaotong University name: Liaocheng People's Hospital name: The Second Affiliated Hospital of Chongqing Medical University briefSummary: The purpose of this clinical trial is to evaluate the effectiveness and safety of Medical Adhesive produced by Beijing Compont Medical Devices Co., Ltd. in the treatment of varicose veins in the lower extremities.
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The main questions it aims to answer is: What medical problems do participants have when using tissue glue? Researchers will compare Medical Adhesive to ClosureFast Endovenous Radiofrequency Ablation (RFA) Catheter (produced by Medtronic Inc. to see if Medical Adhesive works to treat varicose veins in the lower extremities.
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Participants will:
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Treated with closed varicose veins of the lower extremity by Medical Adhesive or ClosureFast.
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Return to the hospital at 1, 12, and 24 weeks postoperatively for Doppler ultrasound, and at 4, 12, 24 weeks postoperatively for venous scoring. conditions: Varicose Veins of Lower Limb studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 188 type: ACTUAL name: Medical Adhesive name: ClosureFast Endovenous Radiofrequency Ablation(RFA) Catheter measure: Clinical success rate measure: Technical success rate measure: Target vascular closure rate at 12 weeks after operation. measure: Clinical signs measure: Venous Clinical Severity Score (VCSS) measure: Aberdeen Varicose Vein Questionnaire (AVVQ) measure: Operation duration measure: Evaluation of product performance sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University People's Hospital city: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06387251 id: 2023-11-437-0003 briefTitle: Assess the Effects of a 30 Day-wellness Program on Digestive Health, Weight and Overall Well-being overallStatus: COMPLETED date: 2024-01-29 date: 2024-02-29 date: 2024-02-29 date: 2024-04-29 date: 2024-04-29 name: Peryam & Kroll Research Corporation class: OTHER name: Alticor Inc. briefSummary: The digestive system is a pivotal component of human health, playing a crucial role in the absorption of nutrients, elimination of waste, and even influencing mental well-being. Poor digestive health can significantly impact one's quality of life and overall well-being. Issues such as bloating, constipation, or imbalanced gut microbiome can affect one's overall well-being. Moreover, the gut-brain connection underscores how digestive health can affect mental well-being. The gut can contribute to serotonin and energy production thus influencing one's mood, energy levels and cognitive functions, affecting one's emotional stability. Additionally, inadequate nutrient absorption from an imbalanced digestive system may lead to suboptimal health, weakening the body and causing fatigue. Overall, maintaining good digestive health is crucial not only for physical comfort but also for normal metabolism, immune function, cognitive abilities, sleep and skin health, ultimately enhancing the overall quality of life. Products designed by the sponsor contains a blend of ingredients recognized for their potential benefits in promoting digestive health (including prebiotics, probiotics, postbiotics, plant-based extracts and plant-based protein). Furthermore, it is well established in the literature that diet, exercise, hydration and mindfulness all impact our gut health and overall well-being. Therefore, this scientific study seeks to validate the efficacy of the combination of products and life-style changes by assessing its impact on gut health and related health aspects like weight, metabolic health, fitness level, energy/fatigue levels, satiety/hunger, food cravings, cognitive abilities and overall well-being. conditions: Digestive Health studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 150 type: ACTUAL name: 30 day wellness program measure: Bristol Stool Scale measure: Digestive symptom frequency questionnaire measure: Waist Circumference measure: Improvements in sleep measure: Improvements in stress measure: Fitness Level measure: Satiety Responsiveness and Hunger measure: Craving Intensity measure: Cognitive Abilities measure: Fatigue measure: Skin Appearance measure: General Health measure: Program Feedback sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wilkins Research city: Chattanooga state: Tennessee zip: 37421 country: United States lat: 35.04563 lon: -85.30968 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-11 uploadDate: 2024-03-07T13:19 filename: ICF_000.pdf size: 144142 hasResults: False
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<|newrecord|> nctId: NCT06387238 id: PSMA-mHSPC briefTitle: Exploration of the Value of PSMA PET/CT in Dynamic Monitoring of the Efficacy of Novel Endocrine Therapy in Patients With Metastatic Hormone Sensitive Prostate Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2026-06-30 date: 2024-04-29 date: 2024-04-29 name: Peking University First Hospital class: OTHER briefSummary: 1. Based on the treatment response and prognosis of mHSPC patients with novel endocrine therapy, a PSMA PET whole-body tumor burden classification was constructed to guide treatment and evaluate prognosis.
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2. Based on the treatment response and prognosis of mHSPC patients with novel endocrine therapy, a multivariable model will be constructed using quantitative parameters of PSMA PET/CT imaging, pre-treatment gene status, PSA, GS/ISUP and other clinical pathological parameters to further achieve accurate patient classification, guide treatment, and evaluate prognosis. conditions: Prostate Adenocarcinoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients With Metastatic Hormone Sensitive Prostate Cancer, will receive pre-therapeutic PSMA PET/CT and post-therapeutic PSMA PET/CT after three-month novel endocrine therapy. primaryPurpose: DIAGNOSTIC masking: NONE count: 150 type: ESTIMATED name: PSMA PET/CT measure: rPFS measure: PSA-PFS measure: OS sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06387225 id: RC23_0248 briefTitle: Early and Objective Assessment of Neurological Prognosis in Cardiac Arrest Patients acronym: HYPERION-2 overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-12-01 date: 2026-12-01 date: 2024-04-26 date: 2024-04-29 name: Nantes University Hospital class: OTHER briefSummary: Cerebral lesions are responsible for two thirds of deaths in patients admitted to intensive care following cardiac arrest. Patients with neurological lesions should be the priority target for neuroprotective interventions, which are the cornerstone of post-cardiac arrest care (allowing a reduction in the burden of care for patients without this type of lesion). Furthermore, these interventions must be based on a precise assessment of the severity of these brain lesions: carrying out neuro-protective interventions in patients without brain lesions exposes these patients to unnecessary treatment potentially associated with adverse effects without any possible benefit. However, the early assessment of neurological prognosis, particularly on admission to intensive care, is an area where there is little research and where it is not possible to obtain a precise and reproducible assessment. Several tools can be used to assess this prognosis at an early stage: anamnesis and characteristics of the cardiac arrest and the patient's comorbidities, imaging, electrophysiology and biomarkers.
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To assess the predictive value of early biomarker testing in patients resuscitated after cardiac arrest, whatever the cause, the investigators plan to conduct a prospective observational multicentre trial.
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It is important to bear in mind that the aim of this study is not to assess the long-term prognosis of patients suffering cardiac arrest in order to take measures to limit or discontinue active therapies, but simply to provide a reliable tool, simple and quick to use, in order to be able to identify a sub-population of patients who should be the subject of preferential neuro-protection measures, and conversely to simplify management (moderate temperature control, early cessation of sedation, early extubation) for patients with no neurological lesions. conditions: Cardiac Arrest conditions: Neurologic Symptoms conditions: Intensive Care Neurological Disorder studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 608 type: ESTIMATED measure: Dosage of biomarker UCHL-1 (Ubiquitin carboxy-terminal hydrolase L1) at the time of admission to intensive care measure: Dosage of biomarker GFAP (Glial fibrillary acidic protein) at the time of admission to intensive care measure: Neurological outcome at D90 assessed by modified Rankin scale (mRS) measure: Dosage of biomarkers UCHL-1 ((Ubiquitin carboxy-terminal hydrolase L1) and GFAP (Glial fibrillary acidic protein) at the time of admission to intensive care measure: Dosage of biomarkers UCHL-1 ((Ubiquitin carboxy-terminal hydrolase L1) and GFAP( Glial fibrillary acidic protein) at 4 hours for recovery of effective cardiac activity (RACS) measure: Neurological outcome at D90 assessed by modified Rankin scale (mRS) ranging from 0 to 6 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHD Vendée city: La Roche-sur-Yon zip: 85025 country: France name: Gwenael COLIN role: CONTACT lat: 46.66667 lon: -1.43333 facility: APHP - Hôpital Cochin city: Paris zip: 75679 country: France name: Sarah BENGHANEM role: CONTACT lat: 48.85341 lon: 2.3488 facility: CH Saint-Nazaire city: Saint-Nazaire zip: 44600 country: France name: Julien LORBER role: CONTACT lat: 47.28333 lon: -2.2 hasResults: False
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<|newrecord|> nctId: NCT06387212 id: HUI0001 briefTitle: Clinical Efficacy and Safety of 35 kDa Hyaluronan Fragment (HA35) Injection in the Treatment of Skin Problems. overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-05 date: 2024-05 date: 2024-04-26 date: 2024-04-26 name: Nakhia Impex LLC class: INDUSTRY briefSummary: To explore the clinical effect and safety of 35 kDa hyaluronic acid fragment ( HA35 ) combined with negative pressure microneedle technology in improving skin problems. conditions: Skin Inflammation conditions: Cosmetic Skin studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: 35 kDa hyaluronan fragment HA35 injection measure: A skin dryness scale measure: A fair or smooth skin scale measure: A skin pore size scale measure: A inflammatory skin thick hardness scale measure: An erythema color and area scale measure: Self-satisfaction evaluation sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nahia Impex LLC city: Ulaanbaatar country: Mongolia name: Mizhou Hui role: CONTACT phone: 13484005199 email: [email protected] lat: 47.90771 lon: 106.88324 hasResults: False
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<|newrecord|> nctId: NCT06387199 id: 2024-10227 briefTitle: Alleviating Carbohydrate Counting for Patients With Type-1 Diabetes Using a Closed Loop System With Weekly Subcutaneous Semaglutide acronym: SEMA SMA overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-07 date: 2026-07 date: 2024-04-26 date: 2024-04-26 name: McGill University Health Centre/Research Institute of the McGill University Health Centre class: OTHER briefSummary: A closed-loop insulin system, often labelled the "artificial pancreas" (AP), consists of an insulin pump, a continuous glucose monitor, and an interface coordinating between them to regulate insulin dosage based on glucose levels. Primarily designed for managing type 1 diabetes, this system has demonstrated significant benefits in previous studies. Yet, despite these advantages, certain challenges persist.
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Semaglutide, utilized in treating type 2 diabetes and obesity, is a once-weekly injectable medication that elevates levels of a gastrointestinal hormone known as Glucagon-Like Peptide-1 (GLP-1). This hormone alters gastric emptying, inhibits glucagon release, and reduces appetite. While not officially sanctioned for type 1 diabetes treatment in North America, studies have explored its efficacy as an adjunctive therapy alongside insulin, yielding favorable outcomes in blood glucose regulation. Comparable drugs like liraglutide and exenatide have been employed in type 1 diabetes treatment as well, albeit with less pronounced glucose-regulating effects compared to semaglutide, even in type 2 diabetes.
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The goal of this 50-week randomized placebo-controlled crossover 2x4 factorial designed trial is to assess whether commercial automated insulin delivery (AID) systems using rapid-acting insulin with adjunct weekly injections of semaglutide (at the maximally tolerated dose) can replace carbohydrate counting with simple meal announcements (SMA) without degrading glucose control. conditions: Type 1 Diabetes conditions: Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: randomized placebo-controlled crossover 2x3 factorial designed trial primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 26 type: ESTIMATED name: Semaglutide with 4 meal strategies name: Placebo with 4 meal strategies measure: Percentage of daytime plasma glucose levels spent in target range (semaglutide vs. placebo) measure: Percentage of time spent in the range of glucose levels between 3.9 and 7.8 mmol/L measure: Percentage of time spent in glucose levels below 3.9 and 3.0 mmol/L measure: Percentage of time spent in glucose levels above 7.8, 10 and 13.9 mmol/L measure: Mean glucose level measure: Standard deviation of glucose levels as a measure of glucose variability measure: Percentage coefficient of variation of glucose levels measure: Proportions of participants with time in range between 3.9 - 10.0 mmol/L≥ 70% measure: Glycated hemoglobin (HbA1c) measure: Area under the curve 0-2h post meal, 0-3h post peal measure: Average scores between interventions on the Type 1 Diabetes Distress Scale questionnaire measure: Average scores between interventions on the Diabetes Treatment Satisfaction questionnaire measure: Average scores between interventions based on the Hypoglycemic Fear Survey - II measure: Heart rate measure: Blood pressure measure: Measure of body weight measure: Measure of body mass index measure: Measure of waist circumference and hip circumference measure: Measure of waist-to-hip ratio measure: Lipid profile, specifically: LDL-cholesterol, HDL-cholesterol, triglycerides measure: Urine albumin-creatinine ratio sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Research Institute of the McGill University Health Centre city: Montreal state: Quebec zip: H4A 3J1 country: Canada name: Nicholas Sabelli, BSc role: CONTACT phone: (514) 377-9455 email: [email protected] name: Michael Tsoukas, MD role: PRINCIPAL_INVESTIGATOR name: Ahmad Haidar, Ph.D role: SUB_INVESTIGATOR name: Vanessa Tardio, MD role: SUB_INVESTIGATOR lat: 45.50884 lon: -73.58781 hasResults: False
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<|newrecord|> nctId: NCT06387186 id: 2023P003233 briefTitle: Leucine Enriched Essential Amino Acid Powder as an Add-on to a Classic Ketogenic Diet in Refractory Epilepsy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-03-31 date: 2025-03-31 date: 2024-04-26 date: 2024-04-26 name: Elizabeth Anne Thiele class: OTHER name: Ajinomoto USA, INC. name: Ajinomoto Co., Inc. briefSummary: The main purpose of this study is to evaluate the safety and tolerability of a Leucine-Enriched Essential Amino Acid (LEAA) Powder as an add-on to a classic ketogenic diet (KD) in pediatric and adult patients with refractory epilepsy. conditions: Refractory Epilepsy conditions: Drug Resistant Epilepsy studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Leucine-Enriched Essential Amino Acid powder measure: Number of participants with treatment-related adverse events measure: Number of participants with improved nutritional status as assessed by weight. measure: Number of participants with improved nutritional status as assessed by body mass index (BMI). measure: Number of participants with improved nutritional status as assessed by serum ketone and glucose level. measure: Changes in seizure frequency as assessed by seizure diary. measure: Changes in behavior and cognitive function as assessed by a questionnaire. measure: Changes in seizure severity and overall health as assessed by a questionnaire. sex: ALL minimumAge: 2 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02114 country: United States name: Lydia Tsega, MD, MPH role: CONTACT phone: 617-726-6524 email: [email protected] name: Carolyn Wilson role: CONTACT email: [email protected] lat: 42.35843 lon: -71.05977 hasResults: False
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<|newrecord|> nctId: NCT06387173 id: 23-001743 id: NCI-2024-01240 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) briefTitle: Registry of Patients Undergoing Cryoablation for Early Stage Breast Cancer overallStatus: RECRUITING date: 2024-01-04 date: 2025-01-03 date: 2099-01-03 date: 2024-04-26 date: 2024-04-26 name: Jonsson Comprehensive Cancer Center class: OTHER briefSummary: This study evaluates the side effects and outcomes of patients who undergo cryoablation for early stage breast cancer. conditions: Early Stage Breast Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Non-Interventional Study measure: Prospectively track patients who undergo cryoablation for breast cancer and record post-treatment related events. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UCLA / Jonsson Comprehensive Cancer Center status: RECRUITING city: Los Angeles state: California zip: 90095 country: United States name: Aletta Deranteriassian role: CONTACT phone: 310-206-6114 email: [email protected] name: Nimmi S. Kapoor, MD role: CONTACT phone: 818-995-8044 email: [email protected] name: Nimmi S. Kapoor, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False
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<|newrecord|> nctId: NCT06387160 id: ILBS-ACLF-18 briefTitle: To Determine the Predictors of Reversibility for Acute-on-Chronic Liver Failure at 6-months. overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2026-02-27 date: 2026-02-27 date: 2024-04-26 date: 2024-04-26 name: Institute of Liver and Biliary Sciences, India class: OTHER briefSummary: ACLF is defined differently in APASL,EASL and AASLD.APASL talks of reversibility in ACLF as per its definition and constitution of Homogenous population with ACLF.The definition of ACLF as per APASL is an acute hepatic insult manifesting as jaundice (serum bilirubin ≥ 5 mg/dL (85 micromol/L) and coagulopathy (INR ≥ 1.5 or prothrombin activity \<40%) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis, and is associated with a high 28-day mortality .From the point of view of intensivists, events in form of organ dysfunction , failure or mortality would cumulatively effect the outcome.Reversibility of ACLF syndrome is a feature of the ACLF defined by the AARC criteria, as nearly all the patients included are after the index presentation.With mitigation of the acute insult and over time, the hepatic reserve improves ,fibrosis regresses and the portal pressure decreases. Further, unlike patients with decompensated cirrhosis and similar to patients with ALF, the reversal of coagulopathy preceded the reversal of jaundice,that is ,median time to reversal of syndrome, i.e jaundice and coagulopathy was 7 (4-30)days versus 19 (7-60)days for jaundice, respectively. The median time for reversal of syndrome, i.e, jaundice and coagulopathy ,was 30 days. Baseline albumin, AARC score and Transient elastography predicted long term reversibility .The disease severity assessment is needed for prognostication and to guide the therapy. Furthermore,the available prediction scores have been validated at baseline,but none has been evaluated in a dynamic manner for prognostication in ACLF patients.A DYNAMIC Model that could predict the reversibility in ACLF is urgently required. conditions: Acute-On-Chronic Liver Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 480 type: ESTIMATED name: as per institutional protocol measure: To determine predictors of Reversibility[ Serum Bilirubin < 5mg/dl and PTINR <1.5] at 6 months in Patients of Acute on chronic liver failure as defined by Asian pacific association of study of liver disease[APASL] measure: Change in Asian Pacific Association of Research consortium [AARC] Score from baseline to 90 days and 6 month follow up measure: Change in liver stiffness measurement [LSM] by Velocity controlled transient elastography[VCTE] at Baseline and 28 Days with values at 90 Days and 6 months. measure: Change in Spleen stiffness measurement [SSM] by Velocity controlled transient elastography[VCTE] at Baseline and 28 Days with values at 90 Days and 6 months measure: Change in Grade of fibrosis at Baseline [Day 0 to 28 Day of presentation] measured by Magnetic resonance elastography with 90 Days and 6months values measure: Proportion of Acute on Chronic Liver failure patients achieving reversibility [Sr Bilirubin <5mg/dl and INR <1.5] as per Asian pacific association of study of liver disease[APASL] at 90 Days. measure: Proportion of Acute on Chronic Liver failure patients achieving reversibility [Sr Bilirubin <5mg/dl and INR <1.5] as per Asian pacific association of study of liver disease[APASL] at 6months. measure: Proportion of Acute on Chronic Liver failure patients maintaining reversibility [Sr Bilirubin <5mg/dl and INR <1.5] as per Asian pacific association of study of liver disease[APASL] at 1year. measure: Proportion of Cirrhotic patients of Acute on Chronic Liver failure patients achieving re compensation at 1year. measure: Proportion of Cirrhotic patients of Acute on Chronic Liver failure patients achieving survival at 1year. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of liver and Biliary Sciences city: New Delhi state: Delhi zip: 110070 country: India name: Dr Shreyas Sarvesh, MD role: CONTACT phone: 01146300000 email: [email protected] lat: 28.63576 lon: 77.22445 hasResults: False
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<|newrecord|> nctId: NCT06387147 id: APHP220818 briefTitle: ORal Antibiotics In Acute Mesenteric Ischemia acronym: ORIAMI overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2027-10-01 date: 2027-10-01 date: 2024-04-26 date: 2024-04-26 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Acute mesenteric ischemia (AMI) is a life-threatening condition with an increasing incidence (7-13/100000 PY). The mortality of AMI is associated with the development and extent of transmural intestinal necrosis (IN), ranging from 25% without IN to 75% with IN. Given its potential reversibility, preventing the progression of AMI towards IN is now considered a primary therapeutic goal. Early management of AMI can thus avoid fatal outcomes and prevent lifelong complications such as short bowel syndrome. Following the results of a pilot study showing an improvement in survival and lower resection rates, our team created a first-of-its-kind intestinal stroke center (SURVI unit, Beaujon Hospital, Clichy, France) that provides 24/7 standardized multimodal and multidisciplinary care to AMI patients referred from all hospitals in the Paris region. As no randomized clinical trial has ever been conducted, the treatment offered by SURVI is based on pathophysiological knowledge and observational clinical data. AMI naturally progresses to sepsis, surgical complications, and multi-organ failure, direct consequences of IN. Features of sepsis are reported in up to 90% of AMI patients compared with 3-22% of patients with brain or myocardial ischemia, supporting a specific septic component in AMI. Experimental studies demonstrated reduced translocation and mortality in germ-free animals or after administration of oral antibiotics targeting Gram-negative and anaerobic early bacterial overgrowth and translocation. In a prospective observational study, the investigators recently suggested a protective effect of systematic oral antibiotics in terms of intestinal preservation, yielding a reduced occurrence of IN (HR: 0.16, 95% confidence interval 0.03-0.62). However, the systematic use of oral antibiotics in AMI remains controversial due to the individual and collective risk of increasing the carriage of multi-drug resistant bacterias. conditions: Acute Mesenteric Ischemia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: double-blind Gentamicin + Metronidazole versus placebo primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 196 type: ESTIMATED name: Gentamicin name: Placebo name: Metronidazole measure: The primary objective is to assess the efficacy of oral antibiotics compared to placebo on reducing the rate of intestinal necrosis or death (composite primary outcome) in AMI patients within 30 days following the randomisation. measure: the rate of intestinal necrosis in the 30 days following the randomisation measure: the rate of short bowel syndrome (<200cm of remnant small bowel) at day-30 following the randomisation measure: the length of intestinal resection at day-30 following the randomisation measure: the occurrence of organ failures within the 30 days following the randomisation measure: the length of ICU stay measure: the length of hospital stay measure: expected minor side effects during the 14 days of treatment measure: hypersensitivity reactions during the 14 days of treatment measure: unexpected or serious adverse event throughout the duration of the study measure: the occurrence of healthcare-associated infection measure: the gentamicin during the 14 days of treatment measure: the metronidazole during the 14 days of treatment sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gastroentérologie-Hépatologie Beaujon city: Clichy zip: 92110 country: France name: Alexandre NUZZO, Dr role: CONTACT phone: (0)1 40 87 56 57 email: [email protected] lat: 48.90018 lon: 2.30952 facility: Réanimation - Beaujon city: Clichy zip: 92110 country: France name: Emmanuel WEISS, Dr role: CONTACT email: [email protected] lat: 48.90018 lon: 2.30952 facility: Chirurgie vasculaire city: Paris zip: 75018 country: France name: Yves Hervé CASTIER role: CONTACT email: [email protected] lat: 48.85341 lon: 2.3488 facility: Réanimation Bichat city: Paris zip: 75018 country: France lat: 48.85341 lon: 2.3488 hasResults: False
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<|newrecord|> nctId: NCT06387134 id: TCM for early-stage LUAD briefTitle: Lifei Xiaoji Wan Treatment's of Early-stage NSCLC and Its Impact on the Tumor Microenvironment overallStatus: RECRUITING date: 2022-12-01 date: 2025-01-01 date: 2025-05-31 date: 2024-04-26 date: 2024-04-26 name: Henan University of Traditional Chinese Medicine class: OTHER briefSummary: This study evaluated the relationship between the clinical efficacy, histopathological changes and tumor microenvironment of the pharmacopharmacologic Lifei Xiaoji Wan in the treatment of early stage lung adenocarcinoma, and improved high-level clinical evidence and action targets for the prevention and treatment of early stage lung cancer by traditional Chinese medicine conditions: Early Stage Lung Adenocarcinoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Lifei Xiaoji Wan name: Conventional treatment with Western medicine measure: Lung Cancer Quality of Life Scale (FACT-L) measure: TCM symptoms and syndromes measure: Evaluation of tumor efficacy using RECIST criteria to measure changes in tumor body measure: Tumor markers：CEA measure: Tumor markers：CA211 measure: Tumor markers：squamous cell carcinoma antigen measure: Complete blood count: white blood cells measure: Complete blood count: haemoglobin measure: Complete blood count: Platelet measure: Liver function tests: ALT measure: Liver function tests: AST measure: Renal function tests: BUN measure: Renal function tests: Cr sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mingli Zhao status: RECRUITING city: Zhengzhou country: China name: Mingli Zhao, MD role: CONTACT phone: 0371-66246152 email: [email protected] lat: 34.75778 lon: 113.64861 hasResults: False
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<|newrecord|> nctId: NCT06387121 id: IIT2023060-EC-1 briefTitle: Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Elderly/Unfit Ph- B-ALL overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-12-01 date: 2028-12-31 date: 2024-04-26 date: 2024-04-26 name: Institute of Hematology & Blood Diseases Hospital, China class: OTHER briefSummary: In the treatment of Ph-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL), despite the achievements of chemotherapy and immunotherapy, the therapeutic outcomes are unsatisfactory in elderly or unfit patients. In recent years, tumor immunotherapy has demonstrated a high safety and efficacy profile in refractory Ph- B-ALL patients. These findings suggest that the advancement of immunotherapy application may be an important approach to improve patient survival. In this study, we propose a treatment approach that combines immuno-targeted drugs with low-dose chemotherapy for newly diagnosed elderly or unfit patients with Ph- B-ALL, aiming to enhance the measurable residual disease (MRD)-negative complete remission (CR) rate measured through flow cytometry following induction therapy, reduce the risk of relapse, and ultimately improve patients' overall survival. conditions: Precursor Cell Lymphoblastic Leukemia-Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 53 type: ESTIMATED name: Vincristine name: Cyclophosphamide name: Dexamethasone name: Venetoclax name: Inotuzumab ozogamicin name: Blinatumomab name: 6-mercaptopurine name: Methotrexate name: Cytarabine name: Prednisone measure: MRD-negative complete remission rate measured by flow cytometry. measure: Complete remission (CR) rate measure: Overall survival (OS) measure: Relapse free survival (RFS) measure: Disease-free Survival (DFS) measure: Mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06387108 id: 24-0045 briefTitle: Evaluation of a Training Course for Educational Professionals overallStatus: RECRUITING date: 2024-04 date: 2025-01 date: 2025-01 date: 2024-04-26 date: 2024-04-26 name: Ludwig-Maximilians - University of Munich class: OTHER name: Prof. OTTO Beisheim Stiftung (Germany) briefSummary: The aim of this study is to evaluate the efficacy of a two-hour online training course on depression and mental health in childhood and adolescence in educational professionals to improve depression and mental health literacy. It will further be investigated whether the course leads to changes in attitudes towards the illness (reduction of stigma) and to an increased behavioural confidence and behavioral change in dealing with pupils with symptoms and illnesses. conditions: Depression conditions: Depression in Children conditions: Depression in Adolescence studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 42 type: ESTIMATED name: training course measure: increase in Knowledge measure: decrease in depression stigma measure: Change in helping behaviour towards pupil measure: Change in conficende in dealing with pupils with mental health issues measure: Evaluation of the training sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: LMU University Hospital (recruitment is conducted online) status: RECRUITING city: Munich country: Germany name: Lisa Feldmann, PhD role: CONTACT email: [email protected] lat: 48.13743 lon: 11.57549 hasResults: False
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<|newrecord|> nctId: NCT06387095 id: 2024/01/756 briefTitle: Efficacy of Parasternal Blocks in Cardiovascular Surgery Patients Undergoing Median Sternotomy overallStatus: RECRUITING date: 2024-02-01 date: 2024-04-16 date: 2025-08-01 date: 2024-04-26 date: 2024-04-26 name: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital class: OTHER_GOV briefSummary: Acute and chronic pain after cardiac surgery is a common problem that negatively affects quality of life. Postoperative pain after cardiac surgery is most intense in the first two days and decreases in the following period. However, postoperative pain with incomplete management in the acute period may become chronic. This may negatively affect the patient's quality of life. Although central blocks such as thoracic epidural and paravertebral blocks are considered the gold standard in analgesia control, the advantages of thoracic plan blocks, which are more superficial due to peroperative heparinisation; coagulation disorders; and procedural difficulties, are undeniable. Thoracic plane blocks, which can also be used in patients receiving anticoagulant and/or antiplatelet therapy, have recently been used for acute pain. The aim of this study was to evaluate the effect of thoracic plane blocks on extubation time, pain scores, intensive care unit (ICU) and hospital stays in patients undergoing median sternotomy. conditions: Postoperative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: randomized controlled primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: INVESTIGATOR count: 300 type: ESTIMATED name: 1. no block name: 2. superficial parasternal block name: 3. deep parasternal block measure: postoperative chronic pain measure: postoperative 24 hours acute pain measure: extubation time measure: icu time sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kosuyolu High Education and Training Hospital status: RECRUITING city: Istanbul state: Kartal country: Turkey name: münire deniz role: CONTACT phone: +905556461015 email: [email protected] name: ömer savluk role: CONTACT phone: +905056877440 email: [email protected] lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06387082 id: 2023-506-00CH1 briefTitle: A Clinical Study of HMPL-506 in Patients With Hematological Malignancies overallStatus: NOT_YET_RECRUITING date: 2024-05-09 date: 2027-10-08 date: 2027-12-08 date: 2024-04-26 date: 2024-04-26 name: Hutchmed class: INDUSTRY briefSummary: This is a Phase 1, multicenter, open-label clinical study of HMPL-506 administered orally in the treatment of hematological malignancies. Only eligible patients who provide the signed informed consent form (ICF) can be enrolled in this study. The study consists of two phases, i.e., a dose escalation phase and a dose expansion phase. The study is expected to enroll approximately 60 to 98 patients, including approximately 30 to 38 patients in the dose escalation phase and approximately 30 to 60 patients in the dose expansion phase. conditions: Hematological Malignancies studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 98 type: ESTIMATED name: HMPL-506 measure: Safety evaluation: Safety Incidence of Dose-limiting Toxicity (DLTs) measure: Safety evaluation: Incidence of serious adverse events (SAEs) and Relationship to Study Drug measure: Efficacy evaluation: Anti-tumor efficacy evaluation. measure: Incidence of adverse events (AEs) and Relationship to Study Drug measure: Adverse Events Associated with Dose Modifications measure: Evaluate electrocardiogram (ECG) assessments. measure: Complete response rate (CR rate) measure: Complete response (CR)+ Complete response with partial recovery of hematology (CRh) rate measure: Composite complete response (CRc) rate measure: Objective response rate (ORR) measure: Time to Complete response (CR)+Complete response with partial recovery of hematology (CRh) measure: Time to Complete response (CR)+Complete response with partial recovery of hematology (CRh) +incomplete hematological recovery (CRi) measure: Time to disease response (TTR) measure: Duration of Complete response (CR)+Complete response with partial recovery of hematology (CRh) measure: Duration of response (DOR) measure: Event-free survival (EFS) measure: Relapse-free survival (RFS) measure: Overall survival (OS) measure: Pharmacokinetic analysis-Maximum concentration (Cmax) measure: Pharmacokinetic analysis: Peak time (Tmax) measure: Pharmacokinetic analysis: Clearance half-life (T1/2) measure: Pharmacokinetic analysis: area under the plasma concentration-time curve (AUC0-t) measure: Evaluate the changes of the Pharmacodynamic Biomarker sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06387069 id: 2023-306-00CH1 briefTitle: A Study to Evaluate HMPL-306 in Patients With IDH1- and IDH2-mutated Acute Myeloid Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2027-06-03 date: 2028-06-29 date: 2024-04-26 date: 2024-04-26 name: Hutchmed class: INDUSTRY briefSummary: An open-label design is adopted in this study. All patients will first undergo pre-screening to determine the mutation status of IDH, and all patients will be assigned to the registry study of the corresponding cohorts of IDH1 and IDH2 based on the pre-screening results. Patients with both IDH1 and IDH2 mutations will be enrolled in the IDH2 cohort. This study is divided into two cohorts. Cohort 1 includes R/R AML patients with IDH1-R132 mutations; Cohort 2 includes R/R AML patients with IDH2-R140 and R172 mutations. The two cohorts are designed independently and will be analyzed separately for statistical hypothesis testing. Patients in both cohorts will be randomized in a 1:1 ratio according to the central Interactive Web Response System (IWRS) into the test or control group, patients in the test group will receive HMPL-306 monotherapy at a dose of 250 mg once daily (QD) (Cycle 1, C1) + 150 mg QD \[starting from Cycle 2 (C2)\]. Patients in the control group will receive salvage chemotherapy (one of four options) consisting of two intensive chemotherapy regimens (MEC regimen and FLAG ± Ida regimen) and two non-intensive chemotherapy regimens (azacitidine and LoDAC) conditions: Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 316 type: ESTIMATED name: HMPL-306 Regimen name: Salvage Chemotherapy Regimen measure: OS measure: CR rate measure: CR + CRh rate measure: CR + CRi + CRh rate measure: Assessments for PK (pharmacokinetics) measure: Assessments for PK (pharmacokinetics) measure: Duration of response (DOR) measure: Transfusion-dependence conversion ratio measure: HSCT(hematopoietic stem cell transplantation) ratio measure: Safety measure: Quality of life (QoL) measure: Time to response (TTR) measure: EFS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06387056 id: XMYY-2024KY040 briefTitle: Genomic Biomarker-guided Neoadjuvant Therapy for Prostate Cancer (SEGNO) acronym: SEGNO overallStatus: RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2029-04-01 date: 2024-04-26 date: 2024-04-26 name: The First Affiliated Hospital of Xiamen University class: OTHER briefSummary: To evaluated the safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer. conditions: Locally Advanced Prostate Cancer conditions: Oligometastatic Prostate Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Rezvilutamide name: Goserelin Microspheres for Injection name: Docetaxel name: Pamiparib name: Cisplatin name: Tislelizumab measure: Rate of clinical complete response (cCR) measure: Rate of pathological minimal residual disease (pMRD) measure: Rate of complete pathologic response (pCR) measure: Progression-free survival measure: Overall survival sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Xiamen University status: RECRUITING city: Xiamen state: Fujian zip: 361000 country: China name: Kaiyan Zhang, M.D. role: CONTACT phone: +865922139714 email: [email protected] name: Haichao Huang, M.D. role: CONTACT phone: +865922139493 email: [email protected] lat: 24.47979 lon: 118.08187 hasResults: False
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<|newrecord|> nctId: NCT06387043 id: MS and Balance briefTitle: Effects of Balance Exercises Performed With Different Visual Stimuli overallStatus: NOT_YET_RECRUITING date: 2024-12-01 date: 2025-03-01 date: 2026-12-01 date: 2024-04-26 date: 2024-04-26 name: Halic University class: OTHER name: Fenerbahce University name: Biruni University name: Istanbul University - Cerrahpasa (IUC) briefSummary: The study aims to examine the effects of balance exercises applied with different visual stimuli on individuals with MS. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Balance exercises with Virtual Reality Glasses name: Balance Exercises with Stroboscopic Glasses name: Balance Exercises with Visual-Based Metaphor Training name: Traditional Balance Exercises measure: Functional Near Infrared Ray Spectroscopy (fNIRS) measure: Timed Up and Go Test measure: Functional Reach Test measure: Berg Balance Scale measure: Timed 25 Step Walking Test measure: Lower Extremity Motor Coordination Test measure: Fatigue Severity Scale measure: Quality of Life in Multiple Sclerosis Patients sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Haliç University city: Istanbul state: Eyüpsultan country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06387030 id: APHP231662 briefTitle: EDN and Eosinophilic Esophagitis acronym: OesEDN overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-26 date: 2024-04-26 name: Assistance Publique - Hôpitaux de Paris class: OTHER name: INRAe - Micalis Institute - Jouy en Josas briefSummary: Eosinophilic esophagitis is a recent and emerging chronic disease, secondary to eosinophilic infiltration of the esophageal mucosa leading to esophageal dysfunction. The diagnosis of this pathology, and monitoring of the efficacy of therapies, relies on the assessment of eosinophilic density on esophageal biopsies: follow-up requires numerous digestive endoscopies under general anesthesia, at each therapeutic change, to assess remission. The search for non-invasive biomarkers of active eosinophilic esophagitis is therefore a subject of major interest.
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The first step is to study EDN (Eosinophil-Derived Neurotoxin), a protein secreted when eosinophils are activated. Several studies have investigated the association between serum EDN, EDN on esophageal brushing or esophageal biopsies with eosinophilic esophagitis activity, and the results look promising. Urinary EDN is associated with atopy but has not been studied in eosinophilic esophagitis. EDN is a biomarker of interest because it is stable over time and, above all, can be measured routinely, making it applicable to routine patient management and care. Our main objective is to evaluate the correlation of EDN in urine, blood and esophageal brushings with the eosinophilic infiltrate counted on esophageal biopsies in patients undergoing upper GI endoscopy at Trousseau Hospital for suspected eosinophilic esophagitis, or as part of the re-evaluation of known eosinophilic esophagitis under treatment.
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Finally, esophageal and salivary dysbiosis has been described in eosinophilic esophagitis without direct evidence of its influence on esophageal inflammation and disease. Our secondary objective is to study the esophageal, salivary and fecal microbiota in these same patients in order to describe the composition, alpha and beta-diversity of bacterial and mycological flora between patients and controls, as well as their association with pathology, and to propose possible alternative therapies aimed at modulating the esophageal and/or salivary microbiota in the management of eosinophilic esophagitis.
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This study will be carried out on a cohort of pediatric patients followed up in the pediatric nutrition and gastroenterology department of the Trousseau-APHP hospital and hospitalized for upper GI endoscopy, either as part of a suspected case of eosinophilic esophagitis, or during follow-up of a previously known case of eosinophilic esophagitis. Blood, urine, stool, saliva, 4 additional esophageal biopsies and esophageal brushings were collected on the day of the digestive endoscopy. Depending on the eosinophilic densitý on the biopsies, subjects will be classified into either the "patient with active eosinophilic esophagitis" group, the "patient with eosinophilic esophagitis in remission" group, or the "control without eosinophilic esophagitis" group. The investigator aim to include 60 patients undergoing upper GI endoscopy, at least half of whoḿ will have active or remitting eosinophilic esophagitis.
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Furthermore, the study of the immunological, allergological and metabolomic signature of this disease is essential to enable the identification of new biomarkers to guide the creation of models combining several biomarkers predictive of eosinophilic density on esophageal biopsies. In a second step, the concentration of a panel of cytokines in blood and esophageal biopsies, the allergic sensitization profile in blood and esophageal biopsies, and an untargeted description of esophageal metabolomics will be compared between groups. In terms of clinical prospects, the investigator plan to develop a patient follow-up strategy based on the biomarkers studied, which is better adapted to clinical practice, better tolerated by patients and less costly than repeated endoscopies with esophageal biopsies. conditions: Eosinophilic Esophagitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 60 type: ESTIMATED name: Blood sampling name: Esophageal biopsies name: Unstimulated saliva sampling name: Urine sampling name: Stool sampling measure: Urinary EDN measure: Serum EDN measure: Endoluminal EDN measure: Eosinophilic infiltrate of esophagus measure: Blood eosinophilia measure: Concentrations of a panel of serum cytokines measure: Concentrations of a panel of cytokines on esophageal biopsies measure: Esophagus metabolomic profile measure: Total IgE and tryptase measure: Food or respiratory allergens sensitivity measure: Serum specific-IgE measure: Specific-IgE on esophageal biopsies measure: Composition of esophageal, salivary and fecal microbiota measure: Quality of life scale measure: Symptom score sex: ALL minimumAge: 2 Years maximumAge: 17 Years stdAges: CHILD facility: Nutrition et gastro-entérologie pédiatrique-Trousseau Hospital city: Paris zip: 75012 country: France name: Anaïs LEMOINE, Doctor role: CONTACT phone: 00 33 1 44 73 60 69 email: [email protected] name: Patrick TOUNIAN, Professor of University role: CONTACT phone: 00 33 1 44 73 60 69 email: [email protected] lat: 48.85341 lon: 2.3488 hasResults: False
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<|newrecord|> nctId: NCT06387017 id: RCAPHM22_0411 briefTitle: Prospective Multicenter Cohort Study to Validate Four Groups of Biomarkers for Assessing Lung Cancer Risk Among Patients With Atheromatous Cardiovascular Disease in a Screening Pathway acronym: BIOCEPTION overallStatus: RECRUITING date: 2024-04-02 date: 2028-07 date: 2029-07 date: 2024-04-26 date: 2024-04-26 name: Assistance Publique Hopitaux De Marseille class: OTHER briefSummary: Interventional study with minimal risks and constraints, with evaluation of the incidence of lung cancers by low-dose thoracic CT scan without injection of contrast medium, of the immunological, inflammatory and metabolic blood profile and of the microbiota; systematic proposal of smoking cessation for active smokers or assistance in maintaining cessation. conditions: Smoking-related Pathology conditions: Atheroma conditions: Non-progressive Cancer > 5 Years conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 750 type: ESTIMATED name: blood sampling name: stool collection name: low dose CT scan measure: biomarker group validation measure: Describe changes in biomarkers over time measure: Describe and compare biomarkers according to clinical characteristics of participants measure: Describe changes in quality of life over time measure: Describe changes in smoking habits over time measure: Describe changes in anxiety over time measure: Describe and compare biomarkers according to medical characteristics of participants measure: Describe and compare biomarkers according to geographic characteristics of participants measure: Describe and compare biomarkers according to socioeconomic characteristics of participants sex: ALL minimumAge: 45 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Assistance Publique Hopitaux de Marseille status: RECRUITING city: Marseille country: France name: David Boulate role: CONTACT email: [email protected] lat: 43.29551 lon: 5.38958 hasResults: False
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<|newrecord|> nctId: NCT06387004 id: 2023-A01971-44 briefTitle: Radiation-Related Dysphagia Development Prediction Using a Two-Step Ultrasonographic Model (R-2D-2) acronym: R-2D-2 overallStatus: RECRUITING date: 2024-01-18 date: 2026-02-18 date: 2026-02-18 date: 2024-04-26 date: 2024-04-26 name: Hopital Forcilles class: OTHER briefSummary: Radiotherapy for head and neck cancers (H\&NC) heightens the risk of swallowing disorders (SD), impacting nutrition, quality of life, and overall health, leading to increased hospitalization and mortality. Dietary plans hinge on patients' nutritional status, swallowing ability, and prognosis. Early interventions are crucial, emphasizing the need for precise assessments guiding prognosis, specifying structures for intervention, and facilitating targeted rehabilitation.
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Clinical examinations lack precision, while existing complementary methods like videofluoroscopy or Fiberoptic Endoscopic Evaluation of Swallowing are invasive, irradiating, resource-intensive, and challenging to access, with uncertain prognostic values.
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Ultrasound imaging emerges as a non-invasive alternative, offering morphological and dynamic evaluation of swallowing-related structures. It enables qualitative and quantitative analyses, improving precision in targeting structures for rehabilitation. Researchers propose an ultrasound predictive model to anticipate SD risk during H\&NC radiotherapy, assessing its reliability and accuracy.
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Over eighteen months, 124 outpatients beginning H\&NC radiotherapy at Forcilles's Hospital will undergo weekly clinical and water-swallow tests by a speech language therapist, with videofluoroscopy when SD is suspected. Ultrasound evaluations pre-treatment and at seven and fourteen days will be conducted by blinded ultrasonographers. Cox models will test ultrasound measurement thresholds for SD prediction, estimating sensitivity, specificity, and prediction values. A global ultrasound predictive model will be developed via logistic multivariable regression.
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The study aims to establish an association between ultrasound markers and SD, improving early detection for tailored management. This non-invasive alternative to videofluoroscopy offers potential for enhancing patient outcomes in H\&NC radiotherapy. conditions: Swallowing Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 112 type: ESTIMATED measure: The primary endpoint is the predictive ability of morphology and/or movement of the tongue, hyoid bone and suprahyoid muscles measured by ultrasound on the occurrence of TDs during radiotherapy. measure: Inter and intra-rater evaluation measure: Predictive capacity of observed changes in ultrasound to anticipate swallowing disorders development measure: Predictive capacity of ultrasound markers measured at inclusion on the incidence of undernutrition during radiotherapy. measure: Predictive capacity of observed changes in ultrasound to anticipate incidence of undernutrition or nutritional status evolution during radiotherapy. measure: Predictive capacity of ultrasound markers for anticipating quality of life assessed by the MD Anderson Dysphagia Inventory questionnaire at 30 days of radiotherapy treatment measure: Ratio of ultrasound measurements of tongue, hyoid bone, and suprahyoid muscle morphology and/or movement successfully conducted sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Forcilles status: RECRUITING city: Férolles-Attilly zip: 77150 country: France name: Aymeric Le Neindre, PhD role: CONTACT phone: +33160646093 email: [email protected] name: Carlos DIAZ LOPEZ, MSc role: PRINCIPAL_INVESTIGATOR lat: 48.73184 lon: 2.63088 hasResults: False
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<|newrecord|> nctId: NCT06386991 id: 2024/206 briefTitle: Effect of Different Irrigation Solutions on Postoperative Pain and Lesion Healing overallStatus: RECRUITING date: 2024-01-01 date: 2024-08-01 date: 2026-01-01 date: 2024-04-26 date: 2024-04-26 name: TC Erciyes University class: OTHER briefSummary: In this study researchers plan to conduct, three different irrigation solutions that are responsible for the release of growth factors necessary for the success of regenerative endodontic treatments will be used. These solutions; Ethylene Diamine Tetra Acetic Acid (EDTA), Etidronic Acid and Citric Acid. The aim of this study is to evaluate the effect of different irrigation solutions used in regenerative endodontic treatment of necrotic open apex molar teeth on postoperative pain. Additionally, the healing of these teeth will be monitored for 1 year. conditions: Endodontic Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 39 type: ESTIMATED name: Using ethylenediaminetetraacetic acid (EDTA), citric acid ((MONO/ANH) and etidronic acid (HEBP) to clean root canals during regenerative endodontic treatments measure: Determining and recording pain levels on the pain scale between treatment sessions measure: In the follow-up sessions after the treatment, the size of the lesion in the bone (mm2) is measured by radiography. sex: ALL minimumAge: 8 Years maximumAge: 15 Years stdAges: CHILD facility: Erciyes Üniversitesi Diş Hekimliği Fakültesi status: RECRUITING city: Kayseri zip: 38039 country: Turkey name: ERASLAN AKYÜZ role: CONTACT phone: 4447138 phoneExt: 0352 email: [email protected] name: ÜSTÜN role: CONTACT phone: 4447138 phoneExt: 0352 email: [email protected] lat: 38.73222 lon: 35.48528 hasResults: False
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<|newrecord|> nctId: NCT06386978 id: 2024/209 briefTitle: Analgesic Efficacy of Transvers Abdominis Plane Block and Transversalis Fascia Plane Block in Cesarean Section overallStatus: RECRUITING date: 2024-05-30 date: 2025-05-30 date: 2026-05-30 date: 2024-04-26 date: 2024-04-26 name: TC Erciyes University class: OTHER briefSummary: This study was designed as a prospective, randomized observational clinical trial.
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A total of 90 adult women were included in the study performed elective cesarean section.
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After excluding patients, the care of 90 was included and 3 of these amounts were reserved.
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TAP Block Group (n=30,Group 1): Spinal Anesthesia + TAP block ; TFP Block group (n=30,Group 2): Spinal Anesthesia + TFP block ; Control group (n=30,Group 3); Spinal Anesthesia + No block; conditions: Obstetric studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 90 type: ESTIMATED name: Transverse Facia Plane Block (TAP Block) name: Transversalis Facia Plane Block (TFP Block) name: Control measure: VAS score evaluation measure: time until the first analgesic request measure: Satisfaction/Dissatisfaction sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Erciyes University status: RECRUITING city: Kayseri zip: 38039 country: Turkey name: Kudret Dogru, Prof role: CONTACT phone: +905334735112 email: [email protected] name: Sibel Pehlivan, Asssoc Prof. role: CONTACT phone: +905052532919 email: [email protected] lat: 38.73222 lon: 35.48528 hasResults: False
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<|newrecord|> nctId: NCT06386965 id: 010.99/15 briefTitle: Sevoflurane Versus Propofol: Effect on Stress Response overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-05 date: 2024-06-05 date: 2024-06-05 date: 2024-04-26 date: 2024-04-26 name: Dr. Lutfi Kirdar Kartal Training and Research Hospital class: OTHER_GOV briefSummary: Stress is defined as hormonal and metabolic changes in the biological system that follow any injury. The stress response occurs as a general systemic response to injury and includes a wide range of endocrinological, immunological and hematological effects. The level of stress in the surgical process can affect not only the patients outcome but also the overall health system.
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The two main agents used in maintenance for general anesthesia are inhalation and intravenous anesthetics. Both inhalation anesthesia and TIVA (Total Intravenous Anesthesia) approaches provide general anesthesia suitable for surgical operations. However, the mechanisms of action of these two methods differ and are not fully understood.
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The aim of investigators' for this study was to investigate the effect of different anesthetic agents on stress inflammatory response in the preoperative, peroperative and postoperative periods. conditions: Propofol conditions: Sevoflurane conditions: Inflammatory Response studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: taking blood sample measure: compare inflammatory markers with sevolurane and propofol : glucose, WBC, procalcitonin, CRP, erytrocyte sedimentation rate, ferritin, pre albumin, albumin,tranferrin sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Health Science, Kartal Dr Lutfi Kırdar Training and Researh Hospital city: İstanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06386952 id: 02/2024-2025 briefTitle: To Compare People With T2DM Who Have Double Hump Versus Who do Not Have Double Hump overallStatus: RECRUITING date: 2024-05-01 date: 2025-05-31 date: 2025-06-30 date: 2024-04-26 date: 2024-04-26 name: Diabetes Foundation, India class: OTHER name: National Diabetes Obesity and Cholesterol Foundation briefSummary: Hypothesis: Double Hump in people with T2D is associated with higher magnitude of complication than people with single hump or no hump
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Objectives: To correlate single and double hump with diabetes complication T2DM patient will be recruited from endocrine OPD
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1. Clinical History and Examination:
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1. General Physical Examination: Height, weight, waist circumference, hip circumference, BMI, Blood Pressure, Hand grip. Buffalo Hump.
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2. Complications Assessment: Patient will be analyzed for:
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Micro Vascular
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(a) Diabetic retinopathy (i) Mild NPDR (ii) Mod NPDR (iii) Macular Edema / CSME (b) Neuropathy (Mild/Mod/Severe) (c) Chronic Kidney Disease (i) Micro/Macro albumin urea (ii) Increased Creatinine (iii) Decreased eGFR
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Macro Vascular
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1. Low ABI/PAD
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2. CVD-MI/PTCA/CABG/Heart Failure
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3. CVS-Stroke/ TIA/Carotid Blockage \>50% conditions: Type 2 Diabetes Mellitus With Complication studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Double Hump increases diabetes complications sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anoop misra status: RECRUITING city: New Delhi state: Delhi zip: 110048 country: India name: Anoop Misra, MD role: CONTACT phone: 01149101222 email: [email protected] name: Koel Dutta, M.Sc role: CONTACT phone: 01149101222 email: [email protected] name: Anoop Misra, MD role: PRINCIPAL_INVESTIGATOR name: Koel Dutta, M.Sc role: SUB_INVESTIGATOR lat: 28.63576 lon: 77.22445 hasResults: False
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<|newrecord|> nctId: NCT06386939 id: 01/2024-2025 briefTitle: Comparison of Micro- and Macrovascular Disease(s) in People With T2D, Who Have Moderate to Severe Acanthosis Nigricans vs. Those Who do Not Have Acanthosis Nigricans overallStatus: RECRUITING date: 2024-05-01 date: 2025-10-30 date: 2025-11-30 date: 2024-04-26 date: 2024-04-26 name: Diabetes Foundation, India class: OTHER name: National Diabetes Obesity and Cholesterol Foundation briefSummary: Hypothesis: Moderate to severe acanthosis nigricans in people with T2D is associated with higher magnitude of complication than people who do not have acanthosis nigricans.
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Objectives: To correlate moderate to severe acanthosis nigricans with diabetes complication
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Methodology:
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T2DM patient will be recruited from endocrine OPD
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1. Clinical History and Examination:
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1. General Physical Examination: Height, weight, waist circumference, hip circumference, BMI, Blood Pressure, Hand grip. Acanthosis Nigricans.
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2. Complications Assessment: Patient will be analysed for:
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Micro Vascular
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(a) Diabetic retinopathy (i) Mild NPDR (ii) Mod NPDR (iii) Macular Edema / CSME (b) Neuropathy (Mild/Mod/Severe) (c) Chronic Kidney Disease (i) Micro/Macro albumin urea (ii) Increased Creatinine (iii) Decreased eGFR
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Macro Vascular
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1. Low ABI/PAD
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2. CVD-MI/PTCA/CABG/Heart Failure
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3. CVS-Stroke/ TIA/Carotid Blockage \>50% conditions: Type 2 Diabetes Mellitus With Complication studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 300 type: ESTIMATED measure: Moderate to Severe Acanthosis Nigricans increases diabetes complications sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anoop misra status: RECRUITING city: New Delhi state: Delhi zip: 110048 country: India name: Anoop Misra, MD role: CONTACT phone: 01149101222 email: [email protected] name: Koel Dutta, M.Sc role: CONTACT phone: 01149101222 email: [email protected] name: Anoop Misra, MD role: PRINCIPAL_INVESTIGATOR name: Koel Dutta, M.Sc role: SUB_INVESTIGATOR lat: 28.63576 lon: 77.22445 hasResults: False
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<|newrecord|> nctId: NCT06386926 id: P.T.REC/012/005075 briefTitle: Radial Shockwave Versus Ultrasound Phonophoresis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07 date: 2024-09 date: 2024-04-26 date: 2024-04-26 name: Cairo University class: OTHER briefSummary: Comparative study to compare the effect of radial shockwave versus ultrasound phonophoresis in management of chronic supraspinatus tendinitis consists of 3 groups exp1(shockwave treatment + conventional physical therapy) , exp2( ultrasound phonophoresis+ conventional physical therapy) and control group ( conventional physical therapy) conditions: Supraspinatus Tendinitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 69 type: ESTIMATED name: Electro Therapy measure: change in the thickness of supraspinatus tendon measure: change in pain intesity measure: Change in shoulder range of motion measure: Function of the Upper Limb measure: measure weight in kg and height in cm sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Cairo university city: Giza country: Egypt name: Shady Alkadry role: CONTACT lat: 30.00808 lon: 31.21093 hasResults: False
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<|newrecord|> nctId: NCT06386913 id: IRB-20-1065 briefTitle: Implementation and Evaluation of Measurement-Based Care (MBC) Training overallStatus: ACTIVE_NOT_RECRUITING date: 2021-02-09 date: 2024-06-30 date: 2024-12-31 date: 2024-04-26 date: 2024-04-26 name: Carilion Clinic class: OTHER name: Virginia Polytechnic Institute and State University briefSummary: The purpose of this study is to get feedback on a new standardized Measurement-Based Care (MBC) provider training program. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Clinicians completed pre- and post-training surveys. Patient satisfaction was assessed prior to and after clinician training. primaryPurpose: OTHER masking: NONE count: 56 type: ACTUAL name: Training measure: Digital MBC training rate measure: Assessing feasibility of a novel digital MBC training in mental health providers (FIM) measure: Assessing acceptability of a novel digital MBC training program in mental health providers (AIM) measure: Assessing appropriateness of a novel digital MBC training program in mental health providers (IAM) measure: Monitoring and Feedback Attitudes Scale (MFA) measure: Attitudes Towards Standardized Assessment Scales: Monitoring and Feedback (ASA-MF) measure: Clinician Attitude and Satisfaction Survey (CASS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Carilion Clinic city: Roanoke state: Virginia zip: 24014 country: United States lat: 37.27097 lon: -79.94143 hasResults: False
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<|newrecord|> nctId: NCT06386900 id: S67595 briefTitle: The Impact of Grand Tour Cycling on Sleep and the Hematological and Metabolomic Profile in World-class Cyclists overallStatus: ENROLLING_BY_INVITATION date: 2023-07-01 date: 2024-09-15 date: 2024-12-01 date: 2024-04-26 date: 2024-04-26 name: KU Leuven class: OTHER briefSummary: This project aims to identify the effect of a 3-week Grand Tour (e.g. Tour de France, Giro d'Italia, and Vuelta a España) on sleep, hematological parameters and the serum metabolome in world-class cyclists. conditions: Overreaching studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 16 type: ESTIMATED name: Cyclist measure: Serum metabolome abundance of cyclists participating in a Grand Tour measure: Sleep efficiency during the Grand Tour measure: Total sleep time during the Grand Tour measure: Blood haemoglobin concentration measure: Wakefulness after sleep onset measure: Light sleep measure: Deep sleep measure: REM sleep measure: Red blood cell concentration measure: Subjective fatigue sex: MALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: KU Leuven city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium lat: 50.87959 lon: 4.70093 hasResults: False
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<|newrecord|> nctId: NCT06386887 id: CASE1824 briefTitle: Fasting During Neoadjuvant Chemotherapy in Patient With Epithelial Ovarian Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-12-01 date: 2026-01-01 date: 2024-04-26 date: 2024-04-26 name: Case Comprehensive Cancer Center class: OTHER briefSummary: The goal of this clinical trial is to see if timed fasting (periods of time that you don't eat) in participants who are receiving chemotherapy prior to surgery is achievable, safe and can improve quality of life, symptoms and outcomes (results) compared to participants who receive standard dietary recommendations in individuals being treated for epithelial ovarian cancer . The main questions it aims to answer are:
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* Is it feasible to use intermittent fasting during neoadjuvant chemotherapy?
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* Is it safe to use intermittent fasting during neoadjuvant chemotherapy?
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