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## Evaluating Changes in Quality of Life After Near Margin-less Adaptive Radiation Therapy Compared to Standard Stereotactic Ablative Body Radiotherapy in Localized Prostate Cancer - NCT ID: NCT06325046 - Study ID: 23-003388 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-06 - Lead Sponsor: Mayo Clinic ### Study Description This clinical trial evaluates changes in quality of life after two treatments with near margin-less adaptive radiation therapy (ART) compared to five treatments with standard stereotactic ablative body radiotherapy (SABR) in patients with prostate cancer that has not spread to other parts of the body (localized). ART is a type of radiation therapy that uses information gathered during the treatment cycle to inform, guide, and alter future radiation treatments with respect to location and dose. It may be able to deliver radiation to the site of disease over a shorter time and with smaller margins (less treatment delivered to nearby healthy tissues). SABR is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Shorter duration near margin-less ART may be just as effective at treating patients with localized prostate cancer but have less quality of life side effects than standard SABR. ### Conditions - Localized Prostate Adenocarcinoma - Stage I Prostate Cancer AJCC v8 - Stage II Prostate Cancer AJCC v8 - Stage III Prostate Cancer AJCC v8 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Computed Tomography - Cone-Beam Computed Tomography - Image-Guided Adaptive Radiation Therapy - Magnetic Resonance Imaging - Stereotactic Ablative Radiotherapy - Survey Administration ### Outcomes Primary Outcomes - Treatment-related, patient-reported early quality of life (QOL) changes Secondary Outcomes - Treatment-related, patient-reported late QOL changes - Incidence of grade ≥ 2 genitourinary an/or gastrointestinal adverse events - Change in International Index of Erectile Function (IIEF) - Change in International Prostate Symptom Score (IPSS) - Change in financial adverse events - COST-FACIT - Fiducial-free treatment - Bladder filling - Biochemical recurrence - Prostate specific antigen (PSA) kinetics - Local recurrence - Overall survival ### Location - Facility: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States @@
## Prospective Validation of the Eleveld Model of Propofol for Procedural Sedation in Adults. - NCT ID: NCT06325033 - Study ID: 18546 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-01 - Lead Sponsor: University Medical Center Groningen ### Study Description The goal of this prospective observational study is to identify effect site concentrations (CET) of propofol using the Eleveld model for different levels of procedural sedation.The main question it aims to answer is to identify CET propofol using the Eleveld model for different levels of procedural sedation as measured by the modified observer's assessment of alertness and sedation score (MOAAS) and EEG monitoring.Participants vital signs will be monitored according to the departmental protocol. Sedation will be administered using Target-Controlled Infusion (TCI) of propofol (administered by effect-site TCI using the Eleveld model) and remifentanil (administered by effect site TCI using the Eleveld model). Target controlled infusion of propofol and remifentanil is according to the departmental protocol. The MOAAS score will be noted every 5 minutes or when the target effect site concentration of propofol is altered. Depth of sedation will also be monitored using a non-invasive BIS® monitor. ### Conditions - Deep Sedation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - To identify effect-site target concentrations of propofol for the Eleveld model that are associated with moderate to deep sedation levels, MOAAS 3-1 and the associated BIS levels in adult patients. Secondary Outcomes - Induction time - Recovery time - Adverse events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Objective Risk Assessment in Patients With Possible Anginal Chest Pain Using Leading Technology - NCT ID: NCT06325020 - Study ID: 337367 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-02-28 - Lead Sponsor: University of Edinburgh ### Study Description The ORACLE study is an observational cohort study designed to explore the feasibility of providing an assessment of chest pain for patients with suspected angina within one working day of referral to specialist services.The primary objective is to determine the feasibility of delivering an objective assessment of risk for participants who have been referred by their primary care provider to the rapid access chest pain clinic with possible angina in a community setting using point of care and patient facing technologies within one working day of referral.Participants will complete a digital health questionnaire, at home, that asks about their risk factors for coronary artery disease, past medical history and their symptoms.Patients will then have a standard 12 lead ECG and perform their own personal ECG. They will then have high sensitivity cardiac troponin measured by point of care high sensitivity cardiac troponin assays as well as a core lab assay.The results of all of the above will allow patients to be started as low, intermediate or high risk for future cardiovascular events. ### Conditions - Angina, Stable - Coronary Artery Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - The assessment of patients with possible angina using the ORACLE pathway ### Outcomes Primary Outcomes - Proportion of participants in whom a chest pain risk assessment is complete within one working day of referral. Secondary Outcomes - Proportion of patients who can have their risk assessment completed in one, two or three or more working days from referral to service until completion of risk assessment. - Proportion of valid and interpretable point-of-care troponin tests - Proportion of personal electrocardiograms that are interpretable - Proportion of participants stratified as low, intermediate, or high risk using objective risk stratification. - Proportion of participants with and without a clinical diagnosis of angina stratified as low, intermediate, or high risk and according to triage status. - Proportion of participants with unscheduled Emergency Department attendance(s) at 3 months stratified as low, intermediate, or high risk and according to triage status. - Proportion of participants with cardiac death or non-fatal myocardial infarction at 3 months stratified as low, intermediate, or high risk and according to triage. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Castor Oil Ingestion and Balloon Catheter for Labor Induction in Nulliparous - NCT ID: NCT06325007 - Study ID: 293-2024-HFH - Status: RECRUITING - Start Date: 2024-04-11 - Completion Date: 2024-12-31 - Lead Sponsor: Holy Family Hospital, Nazareth, Israel ### Study Description The goal of this randomized controlled trial is to examine the efficacy of combining castor oil ingestion with extra-amniotic single balloon catheter for cervical ripening on time from induction to delivery in nulliparous women.The main question it aims to answer are:Does the addition of the use of castor oil to extra-amniotic single balloon reduce the time until birth? Does the addition of the castor oil affect other perinatal outcomes during childbirth? Are the side effects of the castor tolerated by the mothers? Participants will be randomly divided into 2 groups: the study group will drink a mixture of 60 ml of castor oil mixed with 140 ml of orange juice. Thirty minutes later, an extra-amniotic single balloon catheter will be inserted above the internal cervical os and filled with 60 mL of normal saline. In the control group, a foley catheter will be inserted into cervical canal without ingestion of castor oil. ### Conditions - Induction of Labor Affected Fetus / Newborn ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Induction of labor ### Outcomes Primary Outcomes - time to delivery Secondary Outcomes - balloon expulsion time - Bishop score after catheter expulsion - Fetal presentation at the delivery - Duration of the active phase of labor - Duration of second stage - Mode of delivery - Indications for cesarean or operative vaginal deliveries - Intrapartum fever - Number of patients that will require use of intrapartum use of antibiotic treatment. - Number of Participants with that will develop clinical signs of chorioamnionitis. - Number of Participants with that will develop 3rd and 4th degrees perineal lacerations. - Number of Participants with develop postpartrum hemorrhage. - Number of Participants with need blood transfusion. - Side effects related to castor oil use - Oxytocin maximal dosage - Number of participants with Umbilical Cord prolapse. - Apgar score (0 to 10). - pH taken from umbilical artery - Neonatal birthweight - Number of neonates with Neonatal fever ≥ 38 °C - The number of neonates that will develop neonatal sepsis. - The number of neonates that will require antibiotic treatment. - Neonatal complications - The number of neonates that will Admit to neonatal intensive care unit (NICU) - Length of stay in NICU. - neonatal death - Maternal hemoglobin level after delivery. - Number of participants that will require postpartum hysterectomy. - Number of participants that will require postpartum laparotomy. - postpartum maternal complications - The length of stay from birth to discharge home. - Maternal satisfaction from delivery process. ### Location - Facility: Holy Family hospital, Nazareth, Nazareth, N/A, N/A, Israel @@
## Linperlisib Plus Obinutuzumab and Venetoclax for Relapsed and Refractory Blastoid Variant of Mantle Cell Lymphoma. - NCT ID: NCT06324994 - Study ID: YY-20394-BV-MCL - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-12-01 - Lead Sponsor: Dalian Medical University ### Study Description This is a single arm, open label, national multicenter clinical study included patients with relapsed and refractory blastoid variant of mantle cell lymphoma (R/R BV-MCL), aiming to evaluate the efficacy of a chemotherapy free triple therapy of PI3K inhibitor (Linperlisib) combined with anti-CD20 monoclonal antibody (Obinutuzumab) and BCL-2 inhibitor (Venetoclax) in R/R BV-MCL patients. ### Conditions - Mantle Cell Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Linperlisib in combination with Obinutuzumab and Venetoclax ### Outcomes Primary Outcomes - Objective Response Rate (ORR) according to the RECIST 1.1 Secondary Outcomes - Progression-free survival (PFS) - Overall survival (OS) - Duration of Overall Response (DOR) - Adverse event (AE) ### Location - Facility: The Second Hospital Dalian Medical University, Dalian, Liaoning, 116000, China @@
## Using AI Text Messaging to Improve AHA's Life's Essential 8 Health Behaviors - NCT ID: NCT06324981 - Study ID: 22-2097 - Status: RECRUITING - Start Date: 2024-02-26 - Completion Date: 2028-06 - Lead Sponsor: University of Colorado, Denver ### Study Description The goal of our pragmatic clinical trial is to compare how well three different strategies might do to reduce risk factors for cardiovascular disease in patients experiencing health disparities. The three different strategies are: 1) text messages, 2) interactive chatbot messages, and 3) chatbot messages with proactive pharmacist support. To measure cardiovascular risk factors, the investigators are using the American Heart Association's Life's Essential 8 (LE8) factors-blood glucose, cholesterol, blood pressure, physical activity, body mass index, diet, and smoking.This study focuses on improving cardiovascular risk factors for individuals facing health disparities, such as ethnic minorities, limited English proficiency, and low-income groups. These groups are more likely to be seriously affected by cardiovascular diseases. Self-management, or an individual's roles in managing their own chronic disease, includes lifestyle changes, medication adherence. Improving patients' self-management has been shown to improve health behaviors, better disease control and improved patient outcomes.The main question this study aims to answer is if one of the strategies (texting, chatbot, or chatbot with pharmacist support) may improve patient self-management and patient outcomes.The investigators will enroll up to 2,100 patients from three health systems that serve large populations experiencing health disparities: Denver Health, Salud Family Health Centers, and STRIDE Community Health Center.The results might help researchers and health care systems find the best ways to involve patients with health disparities to managing their chronic cardiovascular disease. ### Conditions - Cardiovascular Diseases - Lifestyle Factors ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Generic text messages - Interactive AI chatbot text messaging - Proactive pharmacist support ### Outcomes Primary Outcomes - Change in Life's Essential 8 risk score Secondary Outcomes - Blood pressure (Individual Life's Essential 8 components) - Total cholesterol (Individual Life's Essential 8 components) - Blood sugar (Individual Life's Essential 8 components) - Body Mass Index (Individual Life's Essential 8 components) - Physical activity (Individual Life's Essential 8 components) - Sleep (Individual Life's Essential 8 components) - Smoking habits (Individual Life's Essential 8 components) - Health diet pattern (Individual Life's Essential 8 components) - Self-Efficacy for Managing Chronic Diseases - Number of medication refill gaps (Medication adherence) - Length of refill gaps (Medication adherence) - Clinic events - Risk Score for Recurrent Coronary Heart Disease, Framingham Risk Score - Risk Score for Coronary Heart Disease (2-year risk) - First Event, Framingham Risk Score - Rate of routine clinical visits and/or other procedures associated with the clinical condition - Cost ### Location - Facility: Denver Health, Denver, Colorado, 80204, United States @@
## Ro60 Expression in Macrophages in Sjogren's Disease - NCT ID: NCT06324968 - Study ID: 22-AOIP-01 - Status: RECRUITING - Start Date: 2024-02-09 - Completion Date: 2026-02-09 - Lead Sponsor: Centre Hospitalier Universitaire de Nice ### Study Description Context: The Ro60 protein associates with YRNAs (or RNYs) to form the RoRNP complex, which regulates RNA surveillance and maturation. It is hypothesized that its impairment by nuclear penetration of the anti-Ro60 autoantibodies, would deregulate the anti-inflammatory response in monocytes/macrophages (Mo/Mp) in patients with Sjögren's disease (SD). ### Conditions - Sjogren's Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Positive serology for anti-SSA ### Outcomes Primary Outcomes - SSA/Ro60 interactions Secondary Outcomes - The molecular and functional impact : inflammatory cytokine and chemokine profiles - The molecular and functional impact : cell apoptosis/survival and cellular polarization - The molecular and functional impact : clinical and biochemical phenotypes of CD14+ monocytes/macrophages ### Location - Facility: CHU Nice, Nice, Alpes-Mritimes, 06000, France @@
## Language During Inhalational Induction - NCT ID: NCT06324955 - Study ID: IRB-P00042507 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-11 - Completion Date: 2025-03-11 - Lead Sponsor: Boston Children's Hospital ### Study Description The aim of this study is to compare the impact of common (standard of care) language vs positive language used by clinicians during inhalational induction of anesthesia on anxiety and negative behaviors in children. This is a prospective randomized parallel group trial. Patients will be randomized 1:1 to the common/standard language group or the positive language group. ### Conditions - Emergence Delirium - Anesthesia; Adverse Effect ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Standard/common language during induction - Positive language during induction ### Outcomes Primary Outcomes - Induction compliance Secondary Outcomes - Length of induction - Verbal refusal of mask ### Location - Facility: Boston Children's Hospital, Boston, Massachusetts, 02115, United States @@
## Analgesic Efficacy of Surgeon-administered Transversus Abdominis Plane Blocks for Caesarean Section. - NCT ID: NCT06324942 - Study ID: REB24-0349 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-12 - Lead Sponsor: University of Calgary ### Study Description The purpose of this research study is to evaluate whether or not adding a Transversus Abdominis Plane Block (TAP block) improves pain control for patients having a cesarean section. A TAP block is a type of nerve block where at the end of the surgery an injection of a long acting local anesthetic is made into the abdominal wall. In studies in patient's having other abdominal surgeries this has reduced the amount of narcotics patients need for pain control. This may also led to patients being more active after surgery and maybe spending less time in hospital. ### Conditions - Cesarean Section Complications - Pain, Postoperative ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Surgeon-administered Transversus Abdominis Plane Block 0.25% bupivicaine 0.25 mL/kg ### Outcomes Primary Outcomes - Post operative Pain Secondary Outcomes - Time to first request for rescue analgesia in hours - Post operative Opioid use - Time from surgery to discharge from hospital ### Location - Facility: University of Calgary, Calgary, Alberta, T2N 2T9, Canada @@
## Optimizing a Digital AEP Risk Intervention With Native Women and Communities Aim 1 - NCT ID: NCT06324929 - Study ID: HSR220448 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-03-31 - Lead Sponsor: University of Virginia ### Study Description The purpose of this aim of the ovedrall study is to gather information to inform the development of a digital app that can be used on any platform (smartphone, tablet, computer) for Native American women to help them avoid a pregnancy affected by alcohol. ### Conditions - Alcohol Exposed Pregnancy - Unplanned Pregnancies - Alcohol Use, Unspecified - Contraception Use - Sexual Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Survey ### Outcomes Primary Outcomes - Determine the characteristics of and rate of Native women eligible for, and interested in the CARRII intervention. Secondary Outcomes ### Location - Facility: University of Virginia Fontaine Research Park, Charlottesville, Virginia, 22908, United States @@
## Donor Site Morbidity After Free Vascularized Fibular Graft - NCT ID: NCT06324916 - Study ID: vascularized fibular graft - Status: RECRUITING - Start Date: 2024-01-10 - Completion Date: 2026-12-30 - Lead Sponsor: Assiut University ### Study Description This study was carried out at Assiut University to Asses the long-term donor site morbidity following free vascularized fibular transfer because there is a limited information regarding the long-term donor morbidity of this type of flap. ### Conditions - Osteosarcoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Xray ### Outcomes Primary Outcomes - Donor site morbidity in contrast with surgery benifits this will be measured by point evaluation system Secondary Outcomes ### Location - Facility: Assiut university, Assiut, N/A, N/A, Egypt @@
## Role of Echocardiography in Optimization of Cardiac Catheterization in Children With Congenital Heart Disease - NCT ID: NCT06324903 - Study ID: echo cath CHD - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-10-30 - Lead Sponsor: Assiut University ### Study Description Delineate and evaluate the role of echocardiography in children with congenital heart disease undergoing cardiac catheterization in the pediatric cardiology unit of Assiut university hospitals.1. To improve diagnostic accuracy by creating a systematic approach for image acquisition and interpretation across different procedural timepoints.2. To promote consistent hemodynamic evaluations to reliably assess cardiac function and blood flow.3. To enable optimized procedural planning and intraprocedural guidance via comprehensive delineation of anatomy and pathophysiology.4. To facilitate standardized longitudinal monitoring after interventions to evaluate outcomes and detect complications. ### Conditions - Echocardiography ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - echocardiography and percutaneous cardiac catheterization ### Outcomes Primary Outcomes - congenital heart defect dimensions in mm, - pressure gradient in mmHg across valve Secondary Outcomes - cardiac function by measuring fraction shortening (FS) % in percent - cardiac function TAPSV in cm/sec ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## PET-CT Imaging Features of Meibomian Glands - NCT ID: NCT06324890 - Study ID: 20240225 - Status: RECRUITING - Start Date: 2024-01-31 - Completion Date: 2024-12-31 - Lead Sponsor: Zhongnan Hospital ### Study Description Analysis the results of Dry eye analysis results and PET-CT imaging comprehensively ### Conditions - MGD-Meibomian Gland Dysfunction - Positron-Emission Tomography - Dry Eye ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Lacrimal river height - Tear break-up time - Tear-film lipid layer thickness - Meibomian glands two-dimensional digital infrared images Secondary Outcomes ### Location - Facility: Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 430071, China @@
## Ataxia-telangiectasia: Treating Mitochondrial Dysfunction With Nicotinamide Riboside - NCT ID: NCT06324877 - Study ID: HREC/24/QCHQ/106030 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-10-30 - Lead Sponsor: The University of Queensland ### Study Description Study design: Single arm open-label clinical trial in ataxia-telangiectasia to test the effects of nicotinamide riboside on ataxia scales, immune function, and neurofilament light chain. Study population: 6-10 patients with Ataxia-Telangiectasia. Dose: Nicotinamide riboside 25 mg/kg/day in 3 equal divided doses.Primary endpoint: Scales for assessment and rating of ataxia (SARA), and International Cooperative Ataxia Rating Scale (ICARS). Improvement of at least ½ standard deviation in key clinical scales which includes either; a) significant improvement in total combined scores from the SARA and ICARS scales, and /or b) significant improvements any aspects of the SARA and ICARS scales individually, especially pertaining to; Postural and gait improvements, Improved syllable speed and articulation, Improved fine motor skills.Secondary endpoints: Serum analysis of neurofilament light chain (Nfl), Type 1 Interferon (INFs) epigenetic signature ### Conditions - Ataxia Telangiectasia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Nicotinamide riboside ### Outcomes Primary Outcomes - Scales for assessment and rating of ataxia - International Cooperative Ataxia Rating Scale Secondary Outcomes - Serum analysis of neurofilament light chain - Type 1 Interferon epigenetic signature ### Location - Facility: Queensland Children's Hospital, Brisbane, Queensland, 4101, Australia @@
## START NOW Adapted: Culturally Adapted Version of START NOW - NCT ID: NCT06324864 - Study ID: 2024-00212 - Status: RECRUITING - Start Date: 2024-03-13 - Completion Date: 2026-03 - Lead Sponsor: Prof. Christina Stadler ### Study Description The goal of this clinical trial is to test the effectiveness of the culturally adapted skills-training START NOW in youth migrant populations. The main question it aims to answer is: Is the culturally adapted skills training START NOW more effective than treatment as usual (TAU) in reducing mental health problems in migrants? Participants will be randomly assigned to the intervention group receiving the skills training START NOW Adapted or the control group receiving TAU. Researchers will compare both groups to see if START NOW Adapted is more effective than TAU in reducing mental health problems in migrants. ### Conditions - Depression - Depression/Anxiety - Anxiety - Adolescent - Emotion Recognition - Mental Health - Resilience,Psychological - Refugee Health ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - START NOW Adapted ### Outcomes Primary Outcomes - Change from baseline in symptoms of depression and anxiety at the end of the intervention - Change from baseline in symptoms of depression and anxiety at follow-up Secondary Outcomes - Change from baseline in self-reported perceived stress at follow-up - Change from baseline in self-reported social-ecological resilience at the end of the intervention - Change from baseline in self-reported perceived stress at the end of the intervention - Change from baseline in self-reported social-ecological resilience at follow-up - Change from baseline in facial emotion recognition at the end of the intervention - Change from baseline in facial emotion recognition at follow-up ### Location - Facility: University Psychiatric Clinics Basel, Basel, Basel-Stadt, 4002, Switzerland @@
## The Use of Drospirenone/Estetrol, Nomegestrol Acetate/Estradiol and Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation - NCT ID: NCT06324851 - Study ID: DROVZOEFFIPREP - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2024-03-01 - Lead Sponsor: University of Palermo ### Study Description The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of Drospirenone/Estetrol or Nomegestrol Acetate/Estradiol or Ethinylestradiol/Dienogest, in rapid preparation of endometrium for hysteroscopic polypectomy. ### Conditions - Endometrial Polyp - Endometrial Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Drospirenone / Estetrol - Nomegestrol Acetate / Estradiol - Ethinylestradiol / Dienogest ### Outcomes Primary Outcomes - Quality of endometrial preparation Secondary Outcomes ### Location - Facility: Andrea Etrusco, Palermo, N/A, 90123, Italy @@
## Extended Mesenteric Resection in Ileocecal Crohn's Disease. - NCT ID: NCT06324838 - Study ID: 248-2021-NQ - Status: NOT_YET_RECRUITING - Start Date: 2025-01 - Completion Date: 2029-06 - Lead Sponsor: Odense University Hospital ### Study Description The EXCEED project aims to study the role of the mesentery in disease recurrence in Crohn's disease (CD), as evidence suggests that including the mesentery when doing ileocecal resections can significantly reduce recurrence rates. The EXCEED study is a blinded randomised clinical trial with 204 participants having ileocecal Crohn's disease requiring resection. Participants will undergo either "standard" mesocolic sparing resection or extended mesocolic resection to assess its impact on reducing recurrence at the anastomotic site. The primary endpoint is endoscopic recurrence 12 months postoperatively.Additionally, the study aims to evaluate the efficacy of different surveillance modalities in detecting anastomotic site recurrence. These examinations will be conducted pre- and postoperatively for a cohort of 20 participants.Through this study, we seek to understand the mesentery's role in Crohn's disease recurrence and identify effective non-invasive methods for postoperative monitoring. ### Conditions - Crohn's Disease of Terminal Ileum ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Standard laparoscopic ileocecal resection - Extended laparoscopic ileocecal resection ### Outcomes Primary Outcomes - Endoscopic recurrence Secondary Outcomes - Early endoscopic recurrence - Clinical signs of recurrence / morbidity. - Difference in disease severity - Patient reported outcome 1 - Patient reported outcome 2 - Reoperations - Perioperative complications - Cost of treatment ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Fuzheng Nizeng Formula for Chronic Atrophic Gastritis With Low-grade Intraepithelial Neoplasia, a Multicenter Randomized Controlled Trial - NCT ID: NCT06324825 - Study ID: 2022CR64 - Status: RECRUITING - Start Date: 2022-10-24 - Completion Date: 2024-12-31 - Lead Sponsor: Peking University First Hospital ### Study Description Fuzheng Nizeng Formula (FZNZ) is derived from the classic formula Liujunzi Decoction. Former pilot study found that FZNZ promoted the recovery of gastric atrophy and relieve the relative symptoms. This study is to evaluate its efficacy for chronic atrophic gastritis with low-grade intraepithelial neoplasia, compared with positive control Molduodan granule. ### Conditions - Atrophic Gastritis With Low-grade Intraepithelial Neoplasia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Fuzhegn Nizeng Decoction - Moluodan granules ### Outcomes Primary Outcomes - Recovery rate of Low-grade Intraepithelial Neoplasia Secondary Outcomes - 7-point Global Overall Symptom Scale - Adverse event rate ### Location - Facility: Peking University First Hospital, Beijing, Beijing, 100034, China @@
## Evaluation of 611 in Chinese Children and Adolescents With Moderate to Severe Atopic Dermatitis - NCT ID: NCT06324812 - Study ID: SSGJ-611-PED-AD-Ib/II-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-08 - Lead Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. ### Study Description The primary objective of the study was to evaluate the safety and pharmacokinetic of 611 in Chinese children and adolescents with moderate to severe atopic dermatitis. ### Conditions - Dermatitis, Atopic ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Recombinant Anti-interleukin-4 Receptor Alpha Monoclonal Antibody Injection (611) ### Outcomes Primary Outcomes - Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit. - Minimum concentration (Cmin) Secondary Outcomes - Number of Participants with Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) - Number of Participants with Investigator's Global Assessment (IGA) Score of "0" or "1" and Improvement From Baseline of Greater Than or Equal to (>=) 2 Points - Number of Participants with Eczema Area and Severity Index (EASI) - 50 Response (>= 50% Improvement in Score From Baseline) - Number of Participants with Eczema Area and Severity Index (EASI) - 90 Response (>= 90% Improvement in Score From Baseline) - Number of Participants Who Achieved >=4 Points/ >=3 Points With Improvement From Baseline in Weekly Average of Pruritus Numerical Rating Scale (NRS) Score From Baseline - Percentage Change From Baseline in EASI Score - Change From Baseline in Percent Body Surface Area (BSA) of AD Involvement - Change From Baseline in Weekly Average of Pruritus NRS - Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) - Change From Baseline in Patient Oriented Eczema Measure (POEM) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Position Change Frequency on Hyperbilirubinemia - NCT ID: NCT06324799 - Study ID: 2023/51 - Status: RECRUITING - Start Date: 2024-03-14 - Completion Date: 2024-11-24 - Lead Sponsor: Tarsus University ### Study Description In our study, the effect of the frequency of position changes on hyperbilirubinemia in babies hospitalized in the Neonatal Intensive Care Unit and receiving phototherapy treatment will be investigated.This study was planned as a single-center randomized controlled clinical trial to examine the effect of the frequency of position changes on the time it takes for hyperbilirubinemia to subside in babies receiving phototherapy treatment in the Neonatal Intensive Care Unit of Mersin City Training and Research Hospital.Babies included in the study will be randomly divided into two groups by randomization method. While the babies in the study group will be subjected to position changes (supine, prone, lateral) every 2 hours, the same procedure will be applied to the control group every 6 hours. All newborns included in the study were treated with the Unitest (Blue angel) LED Phototherapy device, which is used as standard in the neonatal intensive care unit, at a distance of 25-40 cm, at a wavelength of 425-475 nm, at 45 watts, at 50/60 Hz. Phototherapy will be applied unidirectionally. During phototherapy, only the perineal area of the babies will be covered with a reduced diaper, and their eyes will be covered with a three-layer, cotton, black eye patch that transmits 99.5% of ultraviolet rays. During phototherapy sessions, the total serum bilirubin level of the patient is checked; Phototherapy will be continued until it falls below the threshold value in the Bhutani nomogram, which is evaluated according to postnatal days and risk factors. The descriptive characteristics of the babies included in the study and their total bilirubin and hematocrit values before the start of phototherapy will be recorded on the form prepared by the researchers. After phototherapy begins, position changes will be made every two hours for babies in the experimental group and every six hours for babies in the control group until the total serum bilirubin value falls below the phototherapy threshold value in the Bhutani nomogram.Bilirubin levels will be measured and recorded by venous measurement at the sixth hour and the 24th hour, and this process will be continued regularly until the bilirubin value decreases to the normal range. This practice is performed routinely in the clinic and will not be considered specific to the study. ### Conditions - Newborn; Vitality - Hyperbilirubinemia, Neonatal ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - phototherapy treatment ### Outcomes Primary Outcomes - Bhutani Nomogram Secondary Outcomes - bilirubin level - hematocrit levels ### Location - Facility: Tarsus State Hospital, Mersin, N/A, N/A, Turkey @@
## Brain Mechanisms of Reducing Polysubstance Use - NCT ID: NCT06324786 - Study ID: 2024 IBMT NF - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2026-08-31 - Lead Sponsor: Arizona State University ### Study Description The proposed study will test whether neurofeedback (NF) could optimize integrative body-mind training (IBMT) practice. ### Conditions - Multiple Drug Use ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - IBMT - NF ### Outcomes Primary Outcomes - Intervention effects on brain function using Functional Magnetic Resonance Imaging (fMRI) - Intervention effects on brain white matter using fMRI - Intervention effects on brain grey matter using fMRI Secondary Outcomes - Intervention effects on addiction behavior using substance use questionnaires in PhenX Toolkit ### Location - Facility: YiYuan Tang, Phoenix, Arizona, 85004, United States @@
## Prevalence of Postpartum Family Planning and Its Association With Spousal Joint Decision-Making in Family Planning - NCT ID: NCT06324773 - Study ID: 9867 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-06-30 - Lead Sponsor: Aga Khan University ### Study Description This community-based cross-sectional study investigates the prevalence of postpartum family planning (PPFP) uptake and its association with joint spousal family planning decision-making among married women in rural Sindh, Pakistan. The study, conducted in Thatta District with a population of approximately 0.98 million people, addresses sociodemographic challenges including high fertility rates, maternal and newborn mortality, and low contemporary contraception use. Targeting married women aged 18-49 who gave birth within the past year, the research utilizes data from the Global Network's Maternal and Newborn Health Registry. Data collection involves a pretested questionnaire administered by trained female data collectors. Statistical analysis includes descriptive statistics and logistic regression using STATA 17. The study aims to fill knowledge gaps regarding factors influencing PPFP uptake, particularly the role of joint decision-making in family planning. Findings could inform targeted interventions to enhance maternal and child health, contribute to existing knowledge, and guide policymakers and healthcare providers in addressing the unmet need for family planning in rural Pakistan. ### Conditions - Postpartum Family Planning ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Prevalence of Postpartum Family Planning Uptake - Frequency of spousal joint decision making for uptake of postpartum family planning - Comparison between spousal joint decision making is using postpartum family planning method and non-users. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Alpha-lipoic Acid Combined With B Vitamins Shows Promise for Treating Restless Legs Syndrome - NCT ID: NCT06324760 - Study ID: LIPOICSPI2018 - Status: COMPLETED - Start Date: 2020-03-04 - Completion Date: 2021-06-02 - Lead Sponsor: Uriach Consumer Healthcare ### Study Description Investigating Tiobec® 400's efficacy in alleviating Restless Legs Syndrome symptoms sheds light on promising therapeutic avenues. ### Conditions - Restless Legs Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Alpha-lipoic acid combined with B vitamins ### Outcomes Primary Outcomes - Measure the subjective RLS symptoms of the participants through the IRLSSG rating scale (IRLS) Secondary Outcomes - Anthropometric parameters of the patients. - Patients' body measurements - Measurements of patient anatomy - Patients' body characteristics. - Measurements of patient anatomy. ### Location - Facility: Medical Center Teknon, Barcelona, N/A, 08017, Spain @@
## Soft Tissue Stability in Immediate Implant Placement Using (VST) Versus Conventional Flap in Type II Extraction Sockets - NCT ID: NCT06324747 - Study ID: 23-046 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-10-23 - Completion Date: 2024-12-01 - Lead Sponsor: British University In Egypt ### Study Description This study compare between the vestibular socket therapy (VST) and the traditional mucoperiosteal flap reflection in immediate implant placement in type II extraction socket in the esthetic zone.The technique of vestibular socket therapy (VST), introduced by Elaskry, enables the placement of implants immediately while simultaneously rehabilitating the entire socket, resulting in excellent esthetic and functional outcomes that meet the expectations of patients. VST involves socket augmentation through a minimally invasive vestibular access incision, eliminating the need for the traditional mucoperiosteal flap reflection, regardless of the extent of socket compromise. ### Conditions - Badly Broken Tooth in a Socket Type II Eligible to be Replaced by Immediate Implant ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Vestibular socket therapy - conventional full thickness flap ### Outcomes Primary Outcomes - Soft Tissue Stability Secondary Outcomes - Bone Regeneration ### Location - Facility: The British university in Egypt, Cairo, New Cairo, N/A, Egypt @@
## Assessment of Safety of Olaparib in Chinese Patients With Ovarian Cancer in the Real-World Setting - NCT ID: NCT06324734 - Study ID: D0817R00082 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-19 - Completion Date: 2024-07-31 - Lead Sponsor: AstraZeneca ### Study Description Study D0817R00081 is a retrospective study using NCID database to assess the safety of Olaparib in Chinese patients with ovarian cancer by examining the incidence, seriousness, and severity of all AEs, including but not limiting to AESIs and SAEs, AEs related to Olaparib, and AEs leading to dose reduction, interruption or discontinuation of Olaparib. The first Olaparib prescription date will be set as the index date. The baseline period is from the patient's first ovarian cancer diagnosis recorded in the database to the patient's first treatment with Olaparib (as early as the database start date of January 1, 2013) to the index date for derivation of lines of therapy or one year pre-index date for other baseline variables. Patients will be followed until the patient's last medical record in the database, 30 days after the last dose of Olaparib, death, or June 30, 2023, whichever comes first. All patients who meet the inclusion/exclusion criteria will be enrolled. ### Conditions - Using NCID Database to Assess the Safety of Olaparib in Chinese Patients With Ovarian Cancer by Examining the Incidence, Seriousness, and Severity of All AE ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The incidence, seriousness, and severity of all AEs Secondary Outcomes - The number and proportion of patients according to different baseline demographics and characteristics - Overall number and proportion of patients with olaprib combination maintenance therapy in PSR patients ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Why do Patients Report Lymphedema After Breast Cancer Treatment Without an Objective Measurable Swelling - NCT ID: NCT06324721 - Study ID: S68133 - Status: RECRUITING - Start Date: 2024-03-26 - Completion Date: 2027-03 - Lead Sponsor: Universitaire Ziekenhuizen KU Leuven ### Study Description Breast cancer related lymphedema (BCRL) is due to its chronicity and impact an extremely dreaded complication after breast cancer treatment.The prevalence rate of objective arm and trunk/ breast BCRL is declining due to the major shift into the treatment approach of breast cancer. However, the prevalence rate of subjective arm and trunk/ breast BCRL is much higher than that of objective BCRL. Subjective BCRL is defined as the diagnosis of BCRL based on the patient's sensation of a difference in size at the arm and/or trunk without any objectively measurable swelling.At this moment, it is not clear how many breast cancer patients experience subjective arm or trunk/breast BCRL and what the underlying mechanisms may be. Therefore, the investigators hypothesize that four mechanisms might be associated with the presence and the severity of subjective arm or trunk/breast BCRL, including sensory processing problems (1. nociceptive and/or 2. neuropathic and/or 3. central) and the presence of disturbed lymphatic transport without clinical manifestation (4. subclinical BCRL).The investigators will set up a prospective longitudinal study with breast cancer patients to determine the prevalence of subjective and objective arm or trunk/ breast BCRL at 1, 6. and 12 month(s) post-surgery and the transitions between the different types of BCRL and to compare the amount of swelling at arm or trunk/ breast, the presence or severity of subclinical BCRL and peripheral and central sensory processing problems between patients with different types of BCRL. In addition, the present study will be undertaken to determine the contributing factors to the severity of subjective arm or trunk/ breast BCRL within the group of patients with subjective BCRL at different time-points after surgery (at 1, 6. and 12 month(s) post-surgery). ### Conditions - Breast Cancer - Lymphedema - Sensory Processing Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Oedema measurements and sensory evaluations ### Outcomes Primary Outcomes - Presence of self-reported swelling at arm - Presence of self-reported swelling at trunk - Presence of self-reported swelling at breast - Presence of subjective arm lymphedema - Presence of subjective trunk lymphedema - Presence of subjective breast lymphedema - Relative hand volume difference - Relative arm volume difference - Extra-cellular water ratio by Bioimpedance Analysis - Extra-cellular water ratio by Bioimpedance Spectroscopy - Presence of objective arm lymphedema - Relative percentage of water content (PWC) ratio - Skin thickness - Presence of objective trunk lymphedema - Presence of objective breast lymphedema Secondary Outcomes - Dermal rerouting score at arm - Dermal rerouting score at trunk - Severity of myofascial adhesions - Myofascial tissue stiffness - Pressure pain thresholds - Arm abduction range - Presence of neuropathic pain - Mechanical detection thresholds - Thermal detection and pain thresholds - Sensory acuity - Dysfunctional inhibitory pain mechanism - Enhanced facilitating mechanism - Body perception - Severity of subjective arm lymphedema - Severity of subjective trunk lymphedema - Severity of subjective breast lymphedema ### Location - Facility: University Hospitals of Leuven, center for lymphedema, Leuven, Vlaams-Brabant, 3000, Belgium @@
## Analysis of Defined Elements on DXA in Patients Undergoing Hip Arthroplasty - NCT ID: NCT06324708 - Study ID: THA_DXA - Status: RECRUITING - Start Date: 2023-02-07 - Completion Date: 2025-10-31 - Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio ### Study Description The purpose of this study is to investigate the role of two-dimensional FEM models obtained from DXA images in the longitudinal assessment of periprosthetic bone, in subjects undergoing hip arthroplasty. Specifically, the study will focus on the joint analysis of changes in the parameters of bone mineral density (BMD) and Bone Strain Index (BSI) at the level of periprosthetic bone of the proximal femur in patients undergoing hip replacement surgery using DXA, evaluating the densitometric variation of these two parameters over time, starting from an immediately postoperative data and checking the change at 6 months to follow the patient through the postoperative course ### Conditions - Bone Resorption - Arthroplasty Complications ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - DXA ### Outcomes Primary Outcomes - Role of two-dimensional FEM models obtained from DXA images in longitudinal evaluation of periprosthetic bone Secondary Outcomes - Role of two-dimensional FEM models of bone resistance to loading - Identification of mechanical stress - Assesment with PROMs: VAS - Assesment with PROMs; HHS - Assesment with PROMs: SF12 - Assesment with PROMs: HOOS PS ### Location - Facility: IRCCS Ospedale Galeazzi-Sant'Ambrogio, Milan, N/A, 20173, Italy @@
## Development and EValuation of an Online Intervention to Reduce Self-Stigma in People With Visible Chronic Skin disEases - NCT ID: NCT06324695 - Study ID: 01GY2105 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-03 - Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf ### Study Description This project aims to develop and evaluate an online intervention to prevent and/or reduce self-stigma in German patients with visible chronic skin diseases. Evaluation of the intervention with regard to effectiveness and feasibility will follow an open-label randomized controlled design with 550 patients in total. The results of the program are expected to provide new insights and markedly extended knowledge on the mechanisms of self-stigma in chronic skin conditions. The new online intervention can be used in routine care, aiming for better patient care in practice and, ultimately decreased extent of self-stigma, increased quality of life of patients, and decreased rates of depression, anxiety, and suicide ideation. ### Conditions - Psoriasis - Alopecia Areata - Hidradenitis Suppurativa - Vitiligo - Atopic Dermatitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - HautKompass ### Outcomes Primary Outcomes - Changes from baseline to post-intervention and follow-up in self-stigma Secondary Outcomes - Changes from baseline to post-intervention and follow-up in generic quality of life - Changes from baseline to post-intervention and follow-up in skin-generic quality of life - Changes from baseline to post-intervention and follow-up in depression - Changes from baseline to post-intervention and follow-up in anxiety - Changes from baseline to post-intervention and follow-up in suicidal ideation - Feasibility of the HautKompass online program - Feasibility of the HautKompass online program - dropouts - User satisfaction with the HautKompass online program - Acceptability of the HautKompass online program ### Location - Facility: Deutscher Vitiligo-Bund e.V., Adelsdorf, N/A, 91325, Germany @@
## ConTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing - NCT ID: NCT06324682 - Study ID: 825/2022/Oss/AOUFe - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2034-12-31 - Lead Sponsor: University Hospital of Ferrara ### Study Description The goal of this observational study is to evaluate the clinical characteristics of patients undergoing permanent cardiac pacing and to compare procedural efficacy and safety of different implantation approaches in the clinical practice of the participating centres. The contribution of non-fluoroscopic anatomical and electrophysiological reconstruction systems to device implantation procedures will also be evaluated.Participants \[patients over 18 years old with an indication to receive a definitive pacemaker/intracardiac defibrillator implant\] will receive a permanent cardiac pacing implant as requested according to European Society of Cardiology (ESC) guidelines; the investigators will evaluate procedural efficacy and safety of different implantation approaches. ### Conditions - Arrhythmias, Cardiac - Atrioventricular Block - Reduced Systolic Function - Atrial Fibrillation - Bradyarrhythmia - Ventricular Tachycardia - Ventricular Dysfunction - Ventricular Fibrillation - Ventricular Arrythmia - Atrioventricular Nodal Disease - Atrioventricular Conduction Defects - Atrioventricular Block Complete - Atrioventricular Block Incomplete - Atrioventricular Junctional Rhythm - Bundle-Branch Block - Left Bundle-Branch Block - Heart Failure, Systolic - Block;Atrioventricular - Block; Arrhythmic - Block; Mobitz - Block, Heart - Block, Fascicular - Block Branch Bundle Left - Heart Failure，Congestive - Heart Arrhythmia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Cardiac pacing - Conventional RV pacing - Cardiac pacing - Conduction System Pacing - Cardiac pacing - Cardiac resynchronization therapy (pacing - CRTP - or defibrillation - CRTD) - Cardiac pacing - Epicardial pacing - Cardiac pacing - Leadless pacing ### Outcomes Primary Outcomes - 30 days efficacy - Rate of hospitalizations for heart failure at 12 months - All cause death at 12 months Secondary Outcomes - All cause and cardiovascular death at 1, 3, 5, 10 years - Onset/worsening of heart failure - Onset/worsening of atrial tachyarrhythmias - Onset/worsening of ventricular tachyarrhythmias - Procedural time - Fluoroscopy time - Radiation exposure - Success rate of CRT in heart failure - Cardiac perforation rate - Hemothorax rate - Pneumothorax rate - Pocket hematoma rate - Pericardial effusion rate - Lead dislocation rate - Lead fracture rate - Cardiac Implantable Electronic Devices infections rate - Reintervention rate ### Location - Facility: Azienda Ospedaliero-Universitaria di Ferrara, Ferrara, FE, 44124, Italy @@
## The Effect of a Ketone Drink on Blood Glucose Levels in People With Type 2 Diabetes - NCT ID: NCT06324669 - Study ID: 4765060 - Status: RECRUITING - Start Date: 2024-03-16 - Completion Date: 2026-01-31 - Lead Sponsor: University of Exeter ### Study Description Ketones are naturally produced by our body and can affect our blood sugar levels. Ketones could be important in the treatment of type 2 diabetes (T2D). The purpose of this research is to determine if a ketone drink can lower blood sugar in people with T2D following a meal. This research will provide new knowledge about the regulation of blood sugar. This may also inform if ketone drinks could be used as a treatment for T2D. ### Conditions - Type 2 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Ketone supplement - Placebo supplement ### Outcomes Primary Outcomes - Rate of endogenous glucose production Secondary Outcomes - Total rate of glucose appearance - Exogenous glucose rate of appearance - Total rate of glucose disappearance - Rate of gluconeogenesis - Rate of glycogenolysis - Beta-cell function - Insulin concentration - Glucagon concentration - GLP-1 concentration - GIP concentration - Glycerol concentration - Free fatty acid concentration - Ketone concentration - Energy expenditure ### Location - Facility: Sport & Health Sciences University of Exeter, Exeter, Devon, EX1 2LU, United Kingdom @@
## The Efficacy of Combining Platelet-rich Plasma With Crystallized Phenol in Pilonidal Sinus Disease - NCT ID: NCT06324656 - Study ID: PRP-PNS - Status: RECRUITING - Start Date: 2023-11-21 - Completion Date: 2024-05-30 - Lead Sponsor: Necmi Kadıoğlu Hospital ### Study Description The use of local liquid phenol for pilonidal sinus disease was first introduced by Maurica and Greenwood in 1964. Phenol, also known as carbolic acid, has been proven to be an effective sclerosing agent for treating pilonidal sinus diseas. Its antiseptic and anesthetic qualities make it suitable for application in awake patients under local anesthesia. The treatment of pilonidal sinus diseas in children with crystallized phenol was first published by Ateş et al in 2018. However, the treatment involving only crystallized phenol can require numerous sessions, potentially extending the duration of the treatment. IIn this study, the investigators, investigated whether the application of platelet-rich plasma following crystallized phenol treatment could accelerate the healing process and reach better outcomes. This study evaluates the efficacy of PRP as a treatment modality for pilonidal sinus disease in pediatric patients. ### Conditions - Pilonidal Sinus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - crystallized phenol + platelet rich plasma application - crystallized phenol ### Outcomes Primary Outcomes - Average time to full daily activities - VAS scores - Healing time - Cosmetic score - Success rate - Recurrence rate Secondary Outcomes - Bleeding rate - Infection rate - Skin burn rate - Total complication rate ### Location - Facility: Mustafa Azizoğlu, Istanbul, N/A, 34430, Turkey @@
## Sensory Motor Integration Training in Erb's Palsy Childern - NCT ID: NCT06324643 - Study ID: Erb's Palsy - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-04-01 - Lead Sponsor: Sara Elsayed Ali Abdelnaby Ali ### Study Description The aim of the study is to Study effect of sensory motor integration training on ADL activities in children with Erb's palsy. ### Conditions - Sensory Motor Integration and Erb's ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - sensory motor integration training ### Outcomes Primary Outcomes - Effect of sensory motor integration training on ADL Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Implementation of Innovative Food Prescription Programs in Older Adults - NCT ID: NCT06324630 - Study ID: 24FIM1266996 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-06-30 - Lead Sponsor: University at Buffalo ### Study Description In the USA, about 10% of grown-ups have a hard time finding healthy food, like fruits and vegetables. It's even harder for older grown-ups who might be sick and find it tricky to move around, which makes it tough to get healthy food. The investigators are trying to fix this by testing two new ways to help older people (aged 65 and up) get nutritious food. The investigators are getting lots of help and ideas from older adults to make these ways work the best they can.The study is happening at the Erie County Medical Center (ECMC) in the East Side of Buffalo, NY, where many African Americans live. This place hasn't been treated fairly, so there aren't many places to buy fresh fruits and vegetables in the local stores. On the ECMC campus, there are three clinics that can help people who can't easily get healthy food. Every participant in our study will be put into one of three programs, each lasting 12 weeks, and they will get food every week.In the "usual care" program, a doctor writes an order, and the participant gets a voucher to buy more fruits and vegetables at a market or store.In the "delivery of a produce prescription box" program, a box of fruits and vegetables is brought to the participant's home. The participant can pick what they like online or by calling a helper. If they don't pick, they get a regular box.In the "delivery of a meal kit box" program, the participant gets the ingredients for three meals in a box. The participant can pick three meals they like online or by calling. If the participant doesn't pick, three meals will be chosen for the participant.For the second and third programs, participants will get messages to remind the participant when to choose their food, when the time to choose is almost up, and when their food is on its way. If a participant can't use messages or the internet, they can call a helper for support. The investigators believe the study will show that these ways can help older adults who have a hard time getting food to eat more fruits and vegetables. The investigators will also find out which way works best compared to the usual way in the Buffalo, NY area. ### Conditions - Food Preferences - Food Habits ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Produce Prescription Delivery - Healthy Meal Kit Delivery - Produce Prescription Mobile Market ### Outcomes Primary Outcomes - Program Redemption Secondary Outcomes - Program Usage - Program Interest by Consenting to Being Contacted/Voiced Interest to Recruiter - Program Enrollment ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Treatment of Failed Carpal Tunnel Syndrome by Dorsal Ulnar Artery Perforator Adipofascial Flap - NCT ID: NCT06324617 - Study ID: soh-Med-24-02-06MS - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-12-30 - Lead Sponsor: Sohag University ### Study Description Carpal tunnel syndrome (CTS) is the most common compressive neuropathy in the general population. Surgical treatment by open or endoscopic carpal tunnel release (CTR) is the first choice of treatment and has clinical success rates of 75% to 90%.The rate of recurrence after primary median nerve release is 3-19% \[1,2\]. Between 0.3% and 12% of cases require surgical revision \[2,3\]. The risk factors for surgical revision for secondary release are male gender, staged or simultaneous bilateral carpal tunnel release, endoscopic release, smoking and rheumatoid arthritis.Treatment failures after primary CTR are classified as persistent CTS, recurrent CTS, or new symptoms. Recurrent symptoms are uncommon and are defined by a symptom-free interval after surgery. Persistent symptoms are relatively common, particularly in elderly patients and in patients with concurrent nerve compression or medical conditions that affect nerve function, such as diabetes. Persistent or recurrent CTS principally results from incomplete release of the transverse carpal ligament but may be accompanied by perineural scarring, leading to compression or tethering of the median nerve.New symptoms may be caused by iatrogenic nerve injury. Surgical treatment of recurrent or persistent CTS after primary CTR usually involves open revision CTR, extended proximally into unscarred tissue, and has also included internal or external neurolysis. Unsatisfactory results following revision CTR are common.A second compression site, or double-crush syndrome, may clinically present as RCTS or PCTS . Thorough preoperative clinical examination may uncover signs of a second compression site, which can then be confirmed on electroneuromyography (ENMG) of the entire arm.To improve outcomes of revision CTR, recent studies have emphasized the importance of median nerve coverage by well-vascularized soft tissue to enhance nerve healing, to prevent tethering in surrounding scar tissue, and to optimize nerve gliding in the carpal tunnel. Several local flaps (hypothenar fat pad flap, tenosynovial flap), regional flaps (posterior interosseous artery flap, reverse radial artery fascial flap, flexor digitorum superficialis flap), and free flap techniques have been described, but consensus for specific flap has not been reached. Following potential iatrogenic median nerve injury and reexploration for a painful neuroma incontinuity, flap coverage may also be beneficial.In 1988, Becker and Gilbert introduced a Fasciocutaneous pedicled flap based on a consistent dorsal perforator of the ulnar artery (absent in 1 % of population) named the dorsal ulnar artery (DUA) flap or simply the Becker flap. The authors described open revision CTR with nerve coverage by a DUA flap in 3 patients with recurrent CTS and reported good results as well as a quick and easy-to-perform dissection with low donor site morbidity and preservation of the radial andulnar artery. Since this introduction, additional studies describing fasciocutaneous DUA flaps have mostly focused on its use for reconstruction of hand or wrist wounds. Despite the original described benefits, additional studies of DUA flaps for the treatment of recurrent or persistent CTS have remained limited. ### Conditions - Failed Carpal Tunnel Syndrome Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Treatment of failed carpal tunnel syndrome by dorsal ulnar artery perforator adipofascial flap ### Outcomes Primary Outcomes - Pain visual analogue scale (VAS) Secondary Outcomes - Two point discrimination test - Tinel sign ### Location - Facility: Sohag university Hospital, Sohag, N/A, N/A, Egypt @@
## Safety, Pharmacokinetics, and Pharmacodynamics of MTX-101 in Healthy Adults and Patients - NCT ID: NCT06324604 - Study ID: MT-101-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-12 - Lead Sponsor: Mozart Therapeutics Australia Pty Ltd ### Study Description First in human study to understand the potential side effects of MTX-101, how long MTX-101 lasts in the human body, and how MTX-101 affects specific human immune cells. ### Conditions - Healthy Volunteers - Celiac Disease - Type 1 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Placebo - MTX-101 ### Outcomes Primary Outcomes - Safety of single, ascending dose levels of MTX-101 - Safety of multiple, ascending dose levels of MTX-101 Secondary Outcomes - pharmacokinetics (PK) of MTX-101 - pharmacokinetics (PK) of MTX-101 - pharmacokinetics (PK) of MTX-101 - anti-drug antibody (ADA) formation ### Location - Facility: Nucleus Network Brisbane, Herston, Queensland, 4006, Australia @@
## Observational Prospective Study to Identify Intestinal Microbial Profiles in Newly Diagnosed Crohn's Disease Patients - NCT ID: NCT06324591 - Study ID: RISKCROHNBIOM - Status: ACTIVE_NOT_RECRUITING - Start Date: 2021-02-03 - Completion Date: 2024-12-31 - Lead Sponsor: Meyer Children's Hospital IRCCS ### Study Description Crohn's disease (CD), a chronic inflammatory disease affecting the intestine, is characterised by a relapsing course. In 25% of cases, the onset of this disease occurs in childhood. Relevant studies have provided evidence of a key role of gut microbial communities (the microbiota) in triggering or maintaining active gut inflammation, pointing to gut dysbiosis as the main event disrupting the balance of microbial communities Recent evidence suggests that, in addition to the bacterial component, the commensal fungal component also plays a crucial role in CD.The purpose of this prospective, longitudinal, study is to characterise the composition of intestinal bacterial and fungal communities in patients 6-18 years newly diagnosed with Crohn Disease in order to identify a possible association of specific faecal microbial profiles with a severe or mild-to-moderate disease course. ### Conditions - Crohn Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Collection biological sample and analysis ### Outcomes Primary Outcomes - Modifications in alpha and beta diversity of stool microbiome profile in patients with different phases of disease course (at diagnosis, remission and after one year of mantainance therapy) Secondary Outcomes - Differences intestinal alpha and beta diversity, microbiome richness and composition between patients at high risk and patients at low risk - Indentification of different patterns of intestinal microbiome as a potential biomarker for high and low risk stratification ### Location - Facility: Medical University of Graz-Educational center for Paediatric Gastroenterology, Hepatology and Nutrition, Department of Paediatrics and adolescence medicine, Graz, N/A, N/A, Austria @@
## Prevalence of Pre-clinical Sjögren Disease and Other Immune Disturbances in Subjects With Autoimmune Thyroiditis Disease - NCT ID: NCT06324578 - Study ID: RC 25/2023 - Status: RECRUITING - Start Date: 2023-09-25 - Completion Date: 2025-12-31 - Lead Sponsor: IRCCS Burlo Garofolo ### Study Description The main study hypothesis is that Sjögren Disease (SD), usually considered a disorder typical of adult females, may occur not exceptionally in adolescence or even in childhood as a subclinical process. There are several pieces of evidence in favor of this hypothesis, from the incidental detection of asymptomatic SD in pediatric age to biobank-based studies showing that biological signs of SD may precede the disease clinical onset by years or decades. The best scenario to verify this hypothesis could be that of autoimmune thyroiditis, for the following three reasons: 1) subjects with Autoimmune thyroiditis (AT) have a high risk of developing SD (7%); 2) in cases with comorbidity of SD and AT the diagnosis of AT had usually been made before; 3) subjects with AT routinely undergo periodic blood examination and neck ultrasonography (US), which may include Salivary Gland Ultrasound (SGUS) providing contributive data to detect an asymptomatic pre-SD. The knowledge of the real association between AT and pre-SD may impact on several aspects of medicine. ### Conditions - Sjögren - Autoimmune Thyroid Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - AT Testing ### Outcomes Primary Outcomes - Prevalence of pre-SD in pediatric subjects with AT - Prevalence of pre-SD in pediatric subjects with AT - Prevalence of pre-SD in pediatric subjects with AT Secondary Outcomes ### Location - Facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, N/A, 34137, Italy @@
## Role of Preoperative D-dimer Levels in the Diagnosis of Adnexal Torsion - NCT ID: NCT06324565 - Study ID: RC 24/2021 - Status: RECRUITING - Start Date: 2022-01-13 - Completion Date: 2024-12-13 - Lead Sponsor: IRCCS Burlo Garofolo ### Study Description Adnexal torsion is the fifth most common gynecologic emergency. Thirty percent of all cases of adnexal torsion occur in females younger than 20 years. Approximately 5 of 100,000 females aged 1-20 years are affected, with girls older than 10 years at increased risk because of hormonal influences and gonadal growth that result in an increased frequency of physiologic and pathologic masses. The most common clinical symptom of torsion is sudden-onset abdominal pain that is intermittent, non-radiating, and associated with nausea and vomiting in 62% and 67% of cases respectively. Moreover, abdominal tenderness is a clinical sign which is reported in up to 88% of patients with adnexal torsion. None of the following tests are useful in the diagnosis of adnexal torsion: leukocytosis, pyuria, C-reactive protein, and erythrocyte sedimentation rate. Actually, transabdominal ultrasonography is the imaging modality of choice with a sensitivity of 92% and specificity of 96% in detecting adnexal torsion. A second-line imaging tool in the diagnosis of adnexal torsion is magnetic resonance, which may require a sedation in selected cases. Consequently, there are no clinical or imaging criteria sufficient to confirm the preoperative diagnosis of adnexal torsion to date. Therefore, patients with a clinical suspicion for adnexal torsion should undergo emergent diagnostic laparoscopy. ### Conditions - Adnexal Torsion ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - D-Dimer test ### Outcomes Primary Outcomes - Diagnostic accuracy of the D-Dimer Secondary Outcomes ### Location - Facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, N/A, 34137, Italy @@
## Defects of Keratinocytes Function in Dermatologic Patients - NCT ID: NCT06324552 - Study ID: RC 16/18 - Status: RECRUITING - Start Date: 2020-10-12 - Completion Date: 2024-05-31 - Lead Sponsor: IRCCS Burlo Garofolo ### Study Description NOTCH signaling in the skin exerts a pivotal role in the regulation of normal keratinocytes turnover by mediating the balance between proliferation, differentiation, apoptosis and autophagic flux progression. Two skin diseases are characterized by the presence of gene variants that cause an impairment in NOTCH signaling: hidradenitis suppurativa(HS) and Dowling-Degos disease(DDD). To date, both HS and DDD are orphan diseases still lacking of specific treatments. This project aims at improving the current knowledge on the pathogenesis of HS and DDD, by deepening the understandings on the role played by keratinocytes in these pathologies and also by determining why mutations found in the same pathway cause different diseases. This study aimed to obtain in vitro models, derived directly from patients (from hair follicles) and from keratinocytes (HaCaT) cell cultures, for the study of these skin pathologies and also for the testing of novel innovative therapies such as photobiomodulation therapy. ### Conditions - Hidradenitis Suppurativa ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Evaluation of the impact of candidate variants in hair follicles epithelial cell biology by generating Knock-Out (KO) keratinocyte cell lines (HaCaT) Secondary Outcomes - Evaluation of the impact of photobiomodulation (PBM) therapy in hair follicles epithelial cells derived from patients and in HaCaT KO cells, ### Location - Facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, N/A, 34137, Italy @@
## Validation of a New Innovative Method for Specific Marker Detection in Celiac Disease - NCT ID: NCT06324539 - Study ID: PNRR-POC-2022-12376280 - Status: RECRUITING - Start Date: 2023-10-04 - Completion Date: 2025-05 - Lead Sponsor: IRCCS Burlo Garofolo ### Study Description Celiac disease (CD) is a common auto-immune disorder induced by gluten ingestion in genetically susceptible individuals (HLA-DQ2/DQ8). Gluten induces small-bowel villous atrophy and a specific immune response characterized by the production of CD-autoantibodies against transglutaminase 2 (anti-TG2) and endomysium (EMA). In symptomatic patients with positive-serum antibodies and villous atrophy, the diagnosis of CD is clearcut.However, 10-30% of patients evaluated for suspected CD show only mild histopathologic changes and fluctuating serologic markers, a condition identified as potential CD. In such cases the diagnosis may remain uncertain.CD-autoantibodies are produced by intestinal B-cells in the early phases of the disease, before their appearance in the serum and when the duodenal mucosa is still normal. Intestinal CD-antibodies (I-CD-abs) are a marker of CD, have a high sensitivity and specificity for CD and identify those patients with potential CD who are at risk of progression to villous atrophy. I-CD-abs can be detected by double immunofluorescence staining on frozen duodenal sections or by using an endomysial antibody assay in the culture medium of duodenal biopsies (EMAbiopsy).The diagnostic accuracy of these techniques is comparable as they both have high sensitivity and specificity. However, their implementation in clinical practice is limited because they require both experienced operators and well-equipped laboratories. There is an unmet need: the development of a new simple and effective diagnostic tool that any gastroenterology unit can use in routine diagnostics to ensure a prompt diagnosis in suspected CD patients, who may benefit from a therapy based on gluten-free diet, and to reduce both unnecessary medical investigations and diagnostic delays.In order to simplify and shorten times for the detection of these intestinal antibodies, the study aims to substitute the EMAbiopsy assay with a supernatant obtained quickly after mechanical lysis of fresh intestinal biopsy specimen. The obtained samples will be tested with rapid (about 15 minutes) immune-chromatographic anti-TG2 assay (Rapid Intestinal anti-TG2 Assay). ### Conditions - Celiac Disease in Children ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Diagnostic Test: Rapid Intestinal anti-TG2 Assay - Diagnostic Test: Rapid Intestinal anti-TG2 Assay ### Outcomes Primary Outcomes - Sensitivity of the EMA-biopsy in comparison to the reference standard (serology + histology) for CD diagnosis - Specificity of the EMA-biopsy in comparison to the reference standard (serology + histology) for CD diagnosis - Sensitivity of the Rapid Intestinal anti-TG2 Assay in comparison to the reference standard (serology + histology) for CD diagnosis - Specificity of the Rapid Intestinal anti-TG2 Assay in comparison to the reference standard (serology + histology) for CD diagnosis Secondary Outcomes ### Location - Facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, N/A, 34137, Italy @@
## Obesity and Health-related Quality of Life in Patients Receiving Bariatric Surgery in the UK - NCT ID: NCT06324526 - Study ID: 070324QL - Status: COMPLETED - Start Date: 2017-06-01 - Completion Date: 2022-11-23 - Lead Sponsor: Imperial College London ### Study Description United Kingdom National Bariatric Surgery Registry (NBSR) records between 1st June 2017 and 23rd November 2022 were used to identify people undergoing primary bariatric (weight-loss) surgery. People undergoing primary bariatric (weight-loss) surgery with one baseline and at least one follow-up visit within one year from surgery were included. Statistical models were used to estimate the relationship between quality of life as assessed by a questionnaire and body mass index at baseline and over time. ### Conditions - Quality of Life - Obesity, Morbid - Bariatric Surgery Candidate ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - EQ-5D (EuroQol Five Dimension) - BMI Secondary Outcomes ### Location - Facility: Department of Surgery and Cancer, Imperial College London, London, N/A, W2 1NY, United Kingdom @@
## Evaluation of the Efficacy and Tolerability of the Mediterranean Diet Pattern in the Exclusion Diet for Patients With Crohn's Disease. - NCT ID: NCT06324513 - Study ID: Med-CDED - Status: RECRUITING - Start Date: 2023-07-27 - Completion Date: 2025-10-27 - Lead Sponsor: Meyer Children's Hospital IRCCS ### Study Description The proposed study aims to assess the efficacy and tolerability of adapting the CDED to the Mediterranean diet pattern, without compromising its key principles, namely the exclusion of ultra-processed foods with potential pro-inflammatory effects on the intestines. The decision to modify the CDED according to the characteristics of the Mediterranean diet pattern and to evaluate the potential of this modified version of the exclusion diet for Crohn's disease in terms of efficacy and tolerability are the main objectives of this study.These objectives are driven not only by scientific evidence regarding the anti-inflammatory potential and protective role against chronic-degenerative diseases demonstrated by the Mediterranean diet but also to allow for greater adherence to Italian dietary traditions and improve compliance with the dietary regimen.Furthermore, to date, there are no comprehensive multi-omic investigations integrating dietary data with microbiome, metabolome, and transcriptome profiles that can demonstrate the effect of the CDED at "omic" levels. A very recent study on pediatric patients shows interesting results regarding differential profiles of fecal metabolites after administration of CDE or NEE in different weeks of therapy. ### Conditions - Crohn Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Mediterranean Crohn's Disease Exclusion Diet (Med-CDED) - Crohn's disease exclusion diet (CDED) ### Outcomes Primary Outcomes - Clinical response to the first phase of diet - Clinical remission rate - Adherence rate to the Med-CDED diet and comparison to the original CDED both in pediatric and adult cohort - Clinical remission rate in adult patients at the end of phase I of diet Secondary Outcomes - Transmural response of the thickness of the intestinal loops both in pediatric and adult cohort - Assessment of the reduction or normalization of inflammation markers both in pediatric and adult cohort - Assessment of clinical remission rate at the end of Phase II of the Med-CDED diet and comparision with the original CDED both in pediatric and adult cohort - Assessment of clinical remission rate at the end of Phase III of the Med-CDED diet and comparision with the original CDED both in pediatric and adult cohort - Endoscopic response rate obtained at 6 months both in pediatric and adult cohort - Assessment of the modification of the intestinal microbiota composition (trough alpha and beta diversity) at the end of the various phases of the Med-CDED and comparison with the original CDED both in pediatric and adult cohort - Assessment of the metabolome profiles at the end of the various phases of the Med-CDED and comparison with the original CDED both in pediatric and adult cohort - Assessment of the trascriptome profiles at the end of the various phases of the Med-CDED and comparison with the original CDED both in pediatric and adult cohort - Ability to maintain a healthy and balanced diet and patient satisfaction with the treatment both in pediatric and adult cohortreceived ### Location - Facility: Meyer Children's Hospital IRCCS, Firenze, N/A, N/A, Italy @@
## Prognostic Role of Bowel Ultrasound Scan in Children Affected by Acute Severe Colitis - NCT ID: NCT06324500 - Study ID: ASC-US - Status: RECRUITING - Start Date: 2020-03-02 - Completion Date: 2025-05-02 - Lead Sponsor: Meyer Children's Hospital IRCCS ### Study Description ASC is a life-threatening medical emergency. The lack of a timely intervention has shown to be associated with a mortality rate higher than 20% in adults, whereas a prompt targeted therapy has displayed a decrease of the aforementioned rate to 1%. Therefore, the identification of predictors of poor outcome trough an objective tool may provide crucial help to individualize the timing of second line treatment initiation. At the state of the art, PUCAI represents the only validated tool to appraise the risk of first-line treatment failure and there is a lack of objective methods with a prognostic value in ASC.BUS has proven to be a reliable tool in assessing disease activity in children with UC and it has also shown statistically significant correlation with endoscopic features of disease activity. Given the literature suggesting a role for BUS in severe UC and the results from our retrospective study we aim to validate our findings trough a prospective assessment of the potential prognostic role of BUS in ASC. ### Conditions - Acute Severe Colitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Colonic wall thickness of BUS (bowel ultrasound) parameter to predict the failure of first line treatment - Color and power Doppler vascularization of BUS (bowel ultrasound) parameter to predict the failure of first line treatment - Mesenteric lymph nodes BUS (bowel ultrasound) parameter Secondary Outcomes - evaluation of the prognostic value of the ultrasound parameters ### Location - Facility: Meyer Children's Hospital IRCCS, Florence, Firenze, 50139, Italy @@
## A New Application in Subacromial Impingement Syndrome - NCT ID: NCT06324487 - Study ID: E-10840098-772.02-7487 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-09-01 - Completion Date: 2024-06-01 - Lead Sponsor: Medipol University ### Study Description Individuals diagnosed with Subacromial Impingement Syndrome by a physical therapist based on MRI results and examination findings will be included in the study. 40 people will be randomly divided into blood flow restrictive exercise (BFRT) and structured exercise program (SEP) groups, 20 people in each group. Participants will receive two evaluations: before starting treatment and immediately after 4 weeks of treatment. Pain, shoulder ROM, shoulder functional level, quality of life, shoulder muscle strength, grip strength, and sleep quality evaluation will be performed. The treatment program will be 5 days a week for a total of 4 weeks. The treatment will be individualized by calculating the appropriate resistance loads for the exercise program. All participants will undergo progressive exercises in sessions conducted by a physiotherapist. ### Conditions - Subacromial Impingement Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Progressive Exercises - Blood Flow Restriction Therapy ### Outcomes Primary Outcomes - Pain İntensity - Shoulder ROM Secondary Outcomes - Quality of Life Assessment - Sleep Quality Assessment - Shoulder Functional Level Assessment - Shoulder Muscle Strength Assessment - Grip Strength Assessment ### Location - Facility: Medipol University, Istanbul, N/A, N/A, Turkey @@
## Clinical and Immunological Evaluation of HA in Treatment of Periodontitis - NCT ID: NCT06324474 - Study ID: HA treatment of periodontitis - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12-12 - Lead Sponsor: Sana'a University ### Study Description To evaluate the immunological effectiveness of Hyaluronic acid as adjunction treatment to scaling and root planning and scaling and root planning alone.Comparison between clinical measurement before and after treatment. Evaluate the level of IGF-1 in treated site as immunological marker if periodontal regeneration. ### Conditions - Periodontitis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Hyaluronic acid - scaling and root planning ### Outcomes Primary Outcomes - Changes in Plaque Index - Changes in Gingival Index - Changes in Papillary Bleeding Index. - Periodontal Probing Depth - Clinical attachment loss - Changes in IGF-1 Secondary Outcomes ### Location - Facility: Sana'a university, Sana'a, N/A, N/A, Yemen @@
## GLP-1 Receptor Agonist for Reduction of Myocardial Injury After Non-cardiac Surgery - NCT ID: NCT06324461 - Study ID: GLUMINS - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2027-12-31 - Lead Sponsor: The University of Hong Kong ### Study Description This is an investigator initiated, multi-center, open-labelled, superiority randomized controlled trial of 372 patients undergoing elective non-cardiac surgery. Recruited patients will be randomized in a 2:1 ratio to receive single subcutaneous dose of Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RAs) 1 to 4 days prior to surgery or receive routine care.Semaglutide (Ozempic; Novo Nordisk, Denmark) is chosen as GLP-1 Receptor Agonists investigational drug for this study. Apart from peri-operative routine care, all recruited subjects will undergo physical, respiratory and cardiac assessments including electrocardiography and blood check including cardiac enzymes. Myocardial injury, cardiovascular outcomes and safety will be assessed and evaluated for efficacy and safety of this prophylactic measurement for the reduction of myocardial injury after non-cardiac surgery. ### Conditions - Myocardial Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Semaglutide 0.25mg subcutaneous injection ### Outcomes Primary Outcomes - Proportion of patients with MINS Secondary Outcomes - Proportion of patients with composite of non-fatal MINS, non-fatal stroke or cardiovascular mortality - Proportion of patients with MINS who do not fulfill the 4th universal definition of myocardial infarction - Proportion of patients with myocardial infarction according to the 4th universal definition of myocardial infarction - Proportion of patients with ischemic stroke - Proportion of patients with cardiovascular death - Proportion of patients with all-cause mortality - Mean days alive and out of hospital - Clinically important atrial fibrillation - Clinically significant hypoglycaemia - Mean peak troponin T concentration - Mean area under curve of troponin T concentration ### Location - Facility: Queen Mary Hospital, Hong Kong, Hong Kong SAR, N/A, China @@
## Self-administered tDCS for Improving Single- and Dual-task Gait in Patients With PD - NCT ID: NCT06324448 - Study ID: PD-tDCS-RCT - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2025-02-28 - Lead Sponsor: Seoul National University Hospital ### Study Description The purpose of this study is to investigate the efficacy and safety of self-administered transcranial direct current stimulation to improve the single- and dual-task gait in patients with Parkinson's disease. ### Conditions - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Transcranial direct current stimulation ### Outcomes Primary Outcomes - Timed-up and go test (sec) - Timed-up and go test under dual-task condition (sec) Secondary Outcomes - Dual-task effect (%) in Timed-up and go test - modified Attention Allocation Index (mAAI) in Timed-up and go test - Gait parameters - Single-leg stance test - Stroop test - Trail making test - New freezing of gait questionnaire (NFoGQ) - Geriatric depression scale (GDS)-short form - Timed-up and go test (sec) - Timed-up and go test under dual-task condition (sec) - Dual-task effect (%) in Timed-up and go test - modified Attention Allocation Index (mAAI) in Timed-up and go test - Gait parameters - Single-leg stance test - Stroop test - Trail making test - New freezing of gait questionnaire (NFoGQ) - Geriatric depression scale (GDS)-short form ### Location - Facility: Seoul National University Hospital, Seoul, N/A, 03080, Korea, Republic of @@
## Apremilast for Alcohol Use Disorder Treatment in Women and Men - NCT ID: NCT06324435 - Study ID: 2000037439 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-02-28 - Lead Sponsor: Yale University ### Study Description For this protocol, the investigators plan to collect pilot data to evaluate apremilast (60mg/day) in adults with Alcohol Use Disorders (AUD). ### Conditions - Alcohol Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Apremilast ### Outcomes Primary Outcomes - Alcohol Consumption Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Exercise as Treatment of Fatigue in Parkinson´s Disease - NCT ID: NCT06324422 - Study ID: Fatigue & Parkinson's disease - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-12-01 - Lead Sponsor: University of Aarhus ### Study Description The primary goal of this study is to test whether 12 weeks of high-intensity aerobic exercise can treat fatigue in Parkinsons disease (PD).The study will be a randomized multi-site controlled trial with follow up. Clinically fatigued persons with PD will be allocated to either 12 weeks of high-intensity aerobic exercise or to a waitlist control group receiving high-intensity resistance exercise after 24 weeks of habitual lifestyle (control period).It is hypothesized that persons with PD receiving 12 weeks of high-intensity aerobic exercise will show superior effects on perceived fatigue (i.e., clinical relevant reductions) when compared to the PD control group (primary hypothesis), and that these effects are sustained after 12-weeks of follow up (secondary hypothesis). ### Conditions - Parkinson's Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Aerobic exercise intervention - Resistance exercise intervention ### Outcomes Primary Outcomes - Change in Modified Fatigue Impact Scale Secondary Outcomes - Change in Fatigue Severity Scale - Change in Parkinson's Fatigue Scale - Change in Parkinson's Disease Questionnaire 39 - Change in Baecke Habitual Physical Activity Questionnaire - Change in Pitchburg Sleep Quality Index - Change in Major Depression Inventory - Change in European Quality of life - 5 Dimensions - Change in Non-motor Symptoms Questionnaire - Change in Brief Pain Inventory (Short Form) - Change in The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale - Change in Six Minute Walk Test - Change in Timed Up and Go - Change in Six Spot Step Test - Change in Symbol Digit Modalities Test - Change in Montreal Cognitive Assessment - Change in Muscle strength - Change in aerobic capacity - Change in Physical activity - Change in Rochester Fatigue Diary - Change in Visual Analog Scale for fatigue, tremor, bradykinesia, rigidity and postural instability ### Location - Facility: Exercise Biology, Dep. of Public Health, Aarhus University, Aarhus, Midtjylland, 8000, Denmark @@
## ImmigrantScreen Telephone Reminder Trial in Colorectal Cancer Screening - NCT ID: NCT06324409 - Study ID: H-350 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-22 - Completion Date: 2025-03-30 - Lead Sponsor: Norwegian Institute of Public Health ### Study Description The goal of this randomized trial is to test the effect of a reminder telephone call in the official native language in the country where the invitee is born, in addition to the reminder letter in Norwegian on participation in the National Colorectal Cancer Screening Program in Pakistani and Somalian immigrants, compared to the reminder letter in Norwegian only.The main question it aims to answer is:•Does a reminder telephone call in the language of origin increase participation in colorectal cancer screening in Pakistani and Somalian immigrants in Norway?Participants in this trial are individuals with Pakistan or Somalia as their country of birth invited to the National Colorectal Cancer Screening Program, who have not participated by mailing a faecal sample to the screening laboratory.In the intervention group, the participants will be called in the official language in their country of origin, to inform about colorectal cancer screening, in addition to the reminder letter in Norwegian language sent to all non-participants.Participants in the comparison group will only be sent the reminder letter in Norwegian language.The researchers will compare differences in the participation rate in the National Colorectal Cancer Screening Program between the intervention and comparison groups. ### Conditions - Cancer Colorectal ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Reminder telephone call ### Outcomes Primary Outcomes - First round screening participation Secondary Outcomes - Overall screening participation ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease - NCT ID: NCT06324396 - Study ID: STUDY00002974 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-12-31 - Lead Sponsor: Children's Mercy Hospital Kansas City ### Study Description This is a single center, open-label, prospective, investigation to quantify the effects liver congestion and fibrosis has on hepatic drug metabolism and transport in children, adolescents, and young adults with Fontan circulation. ### Conditions - Fontan Circulation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Sildenafil 10mg oral tablet (participants <20kg), or 20mg oral tablet (participants ≥20kg) - Pravastatin 20 mg oral tablet (ages <13 years), or 40 mg oral tablet (≥14 years) ### Outcomes Primary Outcomes - Sildenafil concentration as measured by area under the curve (AUC) - Pravastatin concentration as measured by area under the curve (AUC) Secondary Outcomes ### Location - Facility: Children's Mercy Hospital, Kansas City, Missouri, 64108, United States @@
## Enhancing Purpose and Well-Being Through a Volunteering Experience Connecting Veterans With English Language Learners - NCT ID: NCT06324383 - Study ID: 1782599 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-28 - Completion Date: 2025-03-28 - Lead Sponsor: University of Michigan ### Study Description The goal of this study is to refine and test a strategy for engaging Veterans with symptoms of depression, anxiety, and/or PTSD as volunteers to help English language learners (ELLs) improve their speaking skills via structured conversations using videoconferencing. ### Conditions - Depression, Anxiety, PTSD ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Intervention (videoconferencing) ### Outcomes Primary Outcomes - France and Finney "Mattering" - (Patient Health Questionnaire) PHQ-8 - (Generalized Anxiety Disorder) GAD-7 - (Posttraumatic Stress Disorder Checklist) PCL-5 Secondary Outcomes ### Location - Facility: Center for Clinical Management Research (CCMR), North Campus Research Complex, Ann Arbor, Michigan, 48109, United States @@
## Exploratory Pharmacokinetic Study of Virgin Coconut Oil (VCO) - NCT ID: NCT06324370 - Study ID: FIERC-2022-023 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-04-13 - Completion Date: 2024-06-30 - Lead Sponsor: Food and Nutrition Research Institute, Philippines ### Study Description This is a balanced, open-label, single- and multiple-dose pharmacokinetic (PK) study of virgin coconut oil (VCO) among healthy Filipino male adults 18-45 years of age in Dasmariñas, Cavite. This study aims to determine the rate and extent of absorption of virgin coconut oil (VCO) administered in healthy male human study participants under fed conditions in single and multiple doses and to monitor the safety and tolerability of virgin coconut oil (VCO) following the standard protocol developed by the De La Salle Medical and Health Sciences Institute (DLSMHSI). ### Conditions - Pharmacological Action ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: BASIC_SCIENCE ### Interventions - Virgin Coconut Oil ### Outcomes Primary Outcomes - Pharmacokinetics (AUC0-t) - Pharmacokinetics (Cmax) Secondary Outcomes - Pharmacokinetics (AUC0-inf) - Pharmacokinetics (tmax) - Pharmacokinetics (Kel) - Pharmacokinetics (t1/2) - Vital Signs (Systolic and Diastolic Blood Pressure) - Vital Signs (Pulse rate) - Vital Signs (Body temperature) - Vital Signs (Respiratory rate) - Safety and Tolerability (Adverse events) - Post Study Evaluation (Fasting Blood Sugar Test) - Post Study Evaluation (Blood Urea Nitrogen Test) - Post Study Evaluation (Creatinine) - Post Study Evaluation (Uric Acid) - Post Study Evaluation (Serum Glutamic Pyruvic Transaminase Test) - Post Study Evaluation (Serum Glutamic-oxaloacetic Transaminase Test) - Post Study Evaluation (Alkaline Phosphatase Test) - Post Study Evaluation (TPAG- Total Protein, Albumin, Globulin Ratio Test) - Post Study Evaluation (Indirect, Direct and Total Bilirubin) - Post Study Evaluation (Lipid Profile - High-density lipoprotein, Low-density lipoprotein, Cholesterol and Triglycerides) - Post Study Evaluation (Lipase Test) - Post Study Evaluation (Amylase Test) - Post Study Evaluation (Complete Blood Count with Platelet Count Test) - Post Study Evaluation (Complete Urinalysis) - Post Study Evaluation (Fecalysis) ### Location - Facility: Department of Science and Technology-Food and Nutrition Research Institute (DOST-FNRI), Taguig, Metro Manila, 1630, Philippines @@
## Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib in Combination With Trastuzumab Deruxtecan or With Trastuzumab Emtansine and to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread - NCT ID: NCT06324357 - Study ID: 1479-0012 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2028-08-21 - Lead Sponsor: Boehringer Ingelheim ### Study Description This study is open to adults aged 18 years and older with different types of HER2+ cancer that has spread and cannot be removed by surgery. People can take part in this study if their tumours show HER2 aberrations and previous treatment was not successful. The purpose of this study is to find a suitable dose of zongertinib that people with different types of HER2+ cancer that has spread can tolerate best when taken together with trastuzumab deruxtecan (T-DXd) or with trastuzumab emtansine (T-DM1). Another purpose is to check whether zongertinib in combination with T-DXd or with T-DM1 can make tumours shrink. Zongertinib inhibits HER2. HER2 causes cancer cells to grow.The study is split into treatment cycles. All study participants are treated with zongertinib in combination with T-DXd or with T-DM1. This study has 2 parts. In Part 1, participants receive increasing doses of zongertinib. In Part 2, participants are put into different groups by chance. Each group receives a different dose of zongertinib. Every participant has an equal chance of being in each group.During the study, the participants visit the study site regularly. In this study, researchers want to find the highest dose of zongertinib that participants can tolerate when taken together with T-DXd or with T-DM1. To find this out, researchers look at certain severe health problems that a number of participants have. The doctors regularly check the size of the tumour with imaging methods (CT/MRI) during the study. The doctors also regularly check participants' health and take note of any unwanted effects. ### Conditions - Metastatic Breast Cancer - Metastatic Gastric Adenocarcinoma - Gastroesophageal Junction Adenocarcinoma - Esophageal Adenocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Zongertinib - Trastuzumab deruxtecan - Trastuzumab emtansine ### Outcomes Primary Outcomes - Dose escalation (Phase Ib): Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period - Dose optimization (Phase II): Objective response (OR) Secondary Outcomes - Dose escalation (Phase Ib): Objective response (OR) - Dose escalation (Phase Ib): Occurrence of dose-limiting toxicities (DLTs) during the entire treatment period - Dose escalation (Phase Ib): Maximum measured concentration of the analyte in plasma (Cmax) - Dose escalation (Phase Ib): Area under the concentration-time curve of the analyte in plasma from 0 to t2 (AUC0-t2) - Dose optimization (Phase II): Progression-free survival (PFS) - Dose optimization (Phase II): Disease control (DC) - Dose optimization (Phase II): Occurrence of treatment-emergent AEs leading to zongertinib (BI 1810631) dose reduction during the on-treatment period - Dose optimization (Phase II): Maximum measured concentration of the analyte in plasma (Cmax) - Dose escalation (Phase II): Area under the concentration-time curve of the analyte in plasma from 0 to t2 (AUC0-t2) - Dose optimization (Phase II): Patient-reported outcome (PRO) - PRO-CTCAE - Dose optimization (Phase II): Patient-reported outcome (PRO) - EORTC IL46 - Dose optimization (Phase II): Patient-reported outcome (PRO) - EORTC IL19 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy Induced Peripheral Neuropathy (CIPN) - NCT ID: NCT06324344 - Study ID: H-50753-B - Status: RECRUITING - Start Date: 2023-10-02 - Completion Date: 2025-10-02 - Lead Sponsor: Baylor College of Medicine ### Study Description The purpose of this pilot study is to examine the acceptability and proof of concept effectiveness of a wireless Transcutaneous Electrical Nerve Stimulation (TENS) technology to address Chemotherapy Induced Peripheral Neuropathy (CIPN). Participants, who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned with ratio of 1:1 into two groups. The patients and clinicians will be blinded for group allocation. One group will utilize TENS high-dose devices (Intervention group, IG); the other group will utilize low-dose TENS devices (Placebo group, PG). The baseline measurements will be performed, and the patients will take the programmed device home for a duration of 8 weeks. Then, the patients will come back after four weeks (4W) and after 8 weeks (8W) for outcome assessment. The primary outcome will be pain. Secondary outcomes include: nerve conduction and velocity, vibration perception threshold, quality of life. Exploratory outcomes include gait assessment (gait speed, stride length, double stance, and gait steadiness), and balance. ### Conditions - Chemotherapy-induced Peripheral Neuropathy - Pain - Neuropathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - High-Dose TENS - Low-Dose TENS ### Outcomes Primary Outcomes - Change in pain level at 8 weeks from baseline Secondary Outcomes - Change in vibration perception threshold at 8 weeks from baseline - Change in sural nerve conduction velocity and amplitude at 8 weeks from baseline - Changes in Quality of Life at 8 weeks from baseline ### Location - Facility: Baylor College of Medicine, Houston, Texas, 77030, United States @@
## Effect of Decidual Sparing in cs Niche Formation - NCT ID: NCT06324331 - Study ID: Decidual sparing & CS niche - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-12-01 - Lead Sponsor: Assiut University ### Study Description Assessing the impact of endometrial sparing at double-layer uterine closure as a specific surgical technique in CS to reduce the rate of post-cessarian delivery niche develoment ### Conditions - Cesarean Section Complications - Cesarean Section Niche ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SCREENING ### Interventions - Decidual sparing - Non decidual sparing ### Outcomes Primary Outcomes - Impact of decidual sparing on niche formation Secondary Outcomes - Impact of uterine closure technique on post CS niche criteria ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Parenting in 2 Worlds Multisite Trial - NCT ID: NCT06324318 - Study ID: R01DA056417 - Status: RECRUITING - Start Date: 2023-09-14 - Completion Date: 2027-06-30 - Lead Sponsor: Arizona State University ### Study Description This research study will test the effectiveness of a culturally grounded parenting intervention called Parenting in 2 Worlds (P2W). This intervention is designed for American Indian / Alaska Native (AI) parents/guardians of adolescents who reside in urban areas. This will be a multi-regional effectiveness trial across four regions: Northeast (Buffalo/Niagara), Midwest (St. Paul/Minneapolis), Mountain (Denver), and Southwest (Phoenix). There are four specific aims. First, this study will test the effectiveness of Parenting in Two Worlds (P2W) as compared to an informational family health intervention, Healthy Families in 2 Worlds (HF2W), in improving parenting and family functioning. Second, this study will test if the relative effectiveness of P2W, compared to HF2W, varies by parent's/guardian's level of socioeconomic vulnerability, experiences of historical loss, or AI cultural identity. Third, this study will examine if P2W can reduce adolescent (ages 12 - 17) risky health behaviors including substance use, depressive symptoms, suicidality, and risky sexual behaviors. Fourth, this study will examine whether positive changes in parenting and family functioning that result from P2W lead to positive changes in adolescent's health behaviors. ### Conditions - Parenting - Mental Health Wellness 1 - Substance Use - Risky Health Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Parenting in 2 Worlds (P2W) - Healthy Families in 2 Worlds (HF2W) ### Outcomes Primary Outcomes - Change from baseline in family functioning and cohesion - Change from baseline in parental involvement - Change from baseline in parental supervision - Change from baseline in parental monitoring - Change from baseline in positive parenting practices - Change from baseline in relational warmth - Change from baseline in relational hostility - Change from baseline in family conflict - Change from baseline in parental self-agency - Change from baseline in effective discipline - Change from baseline in parental communication about sex - Change from baseline in child problem behaviors. - Change from baseline in decision making about risk behaviors - Change from baseline in substance use - Change from baseline in risky sexual behaviors Secondary Outcomes - Change from baseline in depressive symptoms - Change from baseline in suicidality ### Location - Facility: Phoenix Indian Center, Phoenix, Arizona, 85012, United States @@
## Comparative Study Between Three Different Techniques in Drainage of SRF During PPV in RRD - NCT ID: NCT06324305 - Study ID: SRF drainage techniques in RRD - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-04 - Lead Sponsor: Ain Shams University ### Study Description The study will investigate and compare the three techniques in drainage of subretinal fluid in patients with macula off RRD: namely using the original break, performing a posterior drainage retinotomy and using PFC with drainage through the original break or peripheral retinotomy regarding the presence of persistent sub-retnal fluid and related intra or postoperative complications ### Conditions - Rhegmatogenous Retinal Detachment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pars plana vitrectomy (PPV) and drainage of subretinal fluid ### Outcomes Primary Outcomes - The presence versus absence of sub-macular fluid using each of the three different techniques in pars plana vitrectomy (PPV) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect Of Digital Smile Design on Quality Of Life In Complete Denture Wearers - NCT ID: NCT06324292 - Study ID: FDASU-RecID112324 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-09-15 - Lead Sponsor: Ain Shams University ### Study Description The aim of the current study protocol is to compare the effect of two complete dentures made for completely edentulous patients; one digitally constructed using digital smile design (DSD) and another one conventionally constructed on the patient's quality of life and patient's satisfaction.It is a clinical trial in which two dentures will be made for each patient, one will be digitally constructed using digital smile design (DSD) and the other one using the conventional method with a washout period of 3 weeks. Each patient will receive a questionnaire "Oral Health Impact Profile -19" (OHIP -19) for the edentulous patients to evaluate his satisfaction with the denture. ### Conditions - Complete Edentulism ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - complete denture, CG - complete denture, DG ### Outcomes Primary Outcomes - quality of life assessment Secondary Outcomes ### Location - Facility: Faculty of Dentistry Ain Shams University, Cairo, N/A, 11361, Egypt @@
## Cervical Sliding Sign to Predict Outcome of Induction of Labor - NCT ID: NCT06324279 - Study ID: 000017585 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-09-01 - Completion Date: 2024-04-01 - Lead Sponsor: Ain Shams Maternity Hospital ### Study Description Assess the role of transvaginal ultrasound specifically a sign called cervical sliding sign, in the prediction of success of induction of labor.The prediction of outcome of induction of labor has always been an important topic to all obstetricians. Bishop score is traditionally considered reliable way to predict the outcome of induction of labor by assessing the cervical dilatation, effacement, position, and consistence and assessing the level of the fetal head in the birth canal. Since The bishop score remains a highly subjective method for prediction of outcome of induction of labor, the use of sonographic measurements such as cervical sliding sign can be a better predictor of successful induction of labor.The presence of CSS was defined as the sliding of the anterior cervical lip on the posterior one under gentle pressure of the transvaginal probe.Patients undergoing induction of labor with misoprostol will be checked for the cervical sliding sign. The mode of delivery, induction to active labor time and active labor to delivery time will be recorded and analysed to assess whether the sliding sign is an independent predictor of success of induction. ### Conditions - Induction of Labor - Transvaginal Ultrasound: Cervical Sliding Sign ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Transvaginal ultrasound - Misoprostol 200mcg Tab ### Outcomes Primary Outcomes - Mode of delivery - Induction to active labor time - Active labor to delivery time Secondary Outcomes ### Location - Facility: Maternity hospital, ainshams university hospitals, Cairo, N/A, 11799, Egypt @@
## Study on the Efficacy and Safety of Low-dose CTX as Maintenance Therapy for MM Unsuitable for Transplantation - NCT ID: NCT06324266 - Study ID: 2023NZKY-044-02 - Status: RECRUITING - Start Date: 2023-04-16 - Completion Date: 2025-12-31 - Lead Sponsor: Jinling Hospital, China ### Study Description The investigators will conduct randomized and controlled clinical studies in order to preliminarily explore the efficacy and safety of low-dose cyclophosphamide and lenalidomide in maintenance therapy for MM that is not suitable for transplantation in the standard-risk group. ### Conditions - Newly Diagnosed Multiple Myeloma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cyclophosphamide - Lenalidomide ### Outcomes Primary Outcomes - PFS1 Secondary Outcomes - Incidence of Efficacy as assessed by IMWG - Incidence of Safety as assessed by CTCAE 4.0 ### Location - Facility: Jinling Hospital, Nanjing, Jiangsu, N/A, China @@
## Thoracic Epidural Analgesia With Bilateral Erector Spinae Plane Block in Radical Cystectomy Surgery - NCT ID: NCT06324253 - Study ID: 1/24 UROL2 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-06-10 - Lead Sponsor: Menoufia University ### Study Description The aim of this study is to compare between Thoracic Epidural Analgesia (TEA) with ultrasound-guided bilateral erector spinae plane (ESP) block in radical cystectomy surgery for analgesic efficacy and hemodynamic effects ### Conditions - Post Operative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - bilateral Erector spine block,A dose of 30 ml 0.125% Bupivacaine will be injected. - Thoracic epidural analgesia ### Outcomes Primary Outcomes - Time for first rescue analgesia Secondary Outcomes - Visual analogue scale score at 1st,2nd,4th,6th,8th,12th and 24 h (where 0 is interpreted as no pain, 1-4 mild pain, 5-6 moderate pain, 7-10 severe pain) - the number of rescue analgesics within 24hrs after surgery ### Location - Facility: Menoufia university, Cairo, Shibin Elkom, N/A, Egypt @@
## Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer - NCT ID: NCT06324240 - Study ID: STUDY00004185 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2026-12-31 - Lead Sponsor: Emory University ### Study Description This phase I trial tests the safety, side effects, and best dose of a personalized vaccine (tumor membrane vesicle or TMV vaccine) by itself and in combination with checkpoint inhibitor (pembrolizumab or ipilimumab) in treating patients with triple negative breast cancer. This vaccine is made by taking a piece of patient's triple negative breast cancer to design a vaccine to stimulate the immune system's memory. Patients are treated with the personalized vaccine immunotherapy with or without monoclonal antibodies, such as pembrolizumab and ipilimumab. This approach may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving personalized TMV vaccine with pembrolizumab or ipilimumab may help the immune system attack cancer better and reduce the risk of this breast cancer coming back or growing. ### Conditions - Anatomic Stage I Breast Cancer AJCC v8 - Anatomic Stage IA Breast Cancer AJCC v8 - Anatomic Stage IB Breast Cancer AJCC v8 - Anatomic Stage II Breast Cancer AJCC v8 - Anatomic Stage IIA Breast Cancer AJCC v8 - Anatomic Stage IIB Breast Cancer AJCC v8 - Anatomic Stage III Breast Cancer AJCC v8 - Anatomic Stage IIIA Breast Cancer AJCC v8 - Anatomic Stage IIIB Breast Cancer AJCC v8 - Anatomic Stage IIIC Breast Cancer AJCC v8 - Anatomic Stage IV Breast Cancer AJCC v8 - Early Stage Triple-Negative Breast Carcinoma - Locally Advanced Triple-Negative Breast Carcinoma - Metastatic Triple-Negative Breast Carcinoma - Prognostic Stage I Breast Cancer AJCC v8 - Prognostic Stage IA Breast Cancer AJCC v8 - Prognostic Stage IB Breast Cancer AJCC v8 - Prognostic Stage II Breast Cancer AJCC v8 - Prognostic Stage IIA Breast Cancer AJCC v8 - Prognostic Stage IIB Breast Cancer AJCC v8 - Prognostic Stage III Breast Cancer AJCC v8 - Prognostic Stage IIIA Breast Cancer AJCC v8 - Prognostic Stage IIIB Breast Cancer AJCC v8 - Prognostic Stage IIIC Breast Cancer AJCC v8 - Prognostic Stage IV Breast Cancer AJCC v8 - Recurrent Breast Carcinoma - Unresectable Triple-Negative Breast Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Ipilimumab - Pembrolizumab - Vaccine Therapy ### Outcomes Primary Outcomes - Incidence of adverse events (Phase Ia) - Dose limiting toxicity (Phase Ia) Secondary Outcomes - Immune stimulating activity- T cell activity - Immune stimulating activity- Plasma cytokine/chemokines - Optimal biologic dose - Recommended phase 2 dose (Phase Ib) - Disease control rate - Overall response rate (ORR) - Progression free survival - Overall survival ### Location - Facility: Grady Health System, Atlanta, Georgia, 30303, United States @@
## Effects of Multimodal Music Intervention on Mild Cognitive Impairment Elderly - NCT ID: NCT06324227 - Study ID: 311203003 - Status: RECRUITING - Start Date: 2023-09-17 - Completion Date: 2024-05-26 - Lead Sponsor: National Yang Ming University ### Study Description The goal of this clinical trial is to learn about whether music therapy can ameliorate cognitive function, physical fitness and psychology in mild cognitive impairment and mild dementia population. The main questions it aims to answer are:1. To build a model of multimodal music therapy.2. To discuss the effect of twelve-week multimodal music therapy in ameliorating community-based elders with MCI and mild dementia. Main outcome variables: cognitive function (Montreal Cognitive Assessment Scale, trail making test, Saint Louis University Mental Status Examination). Secondary outcome variables: physical fitness (muscle strength, muscular endurance, flexibility, balance ability), depression. ### Conditions - Mild Cognitive Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: PREVENTION ### Interventions - multimodal music therapy - no intervention ### Outcomes Primary Outcomes - Montreal Cognitive Assessment - Saint Louis University Mental Status - Trail Making Test Secondary Outcomes - 30s chair stand - back scratch test - sit and reach test - 8-foot up-and-go test - handgrip - Geriatric Depression Scale 15 items ### Location - Facility: NationalYangMingU, Taipei, N/A, N/A, Taiwan @@
## Oral Supplementation During PR Participation in COPD - NCT ID: NCT06324214 - Study ID: 2023-9352 - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2025-05-31 - Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre ### Study Description Chronic obstructive pulmonary disease (COPD) is a very common and chronic lung condition and is a leading cause of morbidity and death. These patients have persistent breathlessness and exercise intolerance, affecting their ability to carry out routine daily tasks. Standard COPD treatments include medicines/puffers as well as participation in a Pulmonary Rehabilitation (PR) program. PR programs are delivered by a diverse team of healthcare experts in exercise and nutrition. It is possible that an emerging nutritional oral supplement could target the muscular dysfunction seen in patients with COPD in part by promoting better working mitochondria, the energy 'engine' of muscle. A series of recently published studies in sedentary adults and in older adults have demonstrated the safety, tolerability, and potential clinical effectiveness of this supplement.In this regard, the investigators plan to lead a large randomized controlled trial (RCT) to test whether oral supplementation in patients with COPD who are also participating in a standard PR program will improve overall exercise performance. The investigators will also test muscle strength, cognition, body composition, and other clinically important outcomes such as quality of life. Lastly, the investigators will use muscle tissue from a subgroup of volunteers to investigate the effect on muscle/mitochondrial structure/function.The focus is actually the critical 'first step' before the larger RCT: a pilot and feasibility study on a smaller number of participants with COPD, as an important proof-of-concept that the larger study can, and should, be conducted. ### Conditions - Copd ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Urolithin A (Mitopure) - Placebo ### Outcomes Primary Outcomes - Constant Work Rate Exercise Test (CRWET) Secondary Outcomes - 6-Minute Walk Test (6MWT) - Quadriceps strength - Mitochondrial function - Muscle histology - Tissue microscopy - Tissue microscopy - Specific protein detection - RNA analyses - Body composition - Body impedance - Disease-specific impact on quality of life - Burden of disease - Cognition - Adverse events - Differences in dosed missed - Blood levels of the intervention ### Location - Facility: McGill University Health Centre, Montréal, Quebec, H4A 3J1, Canada @@
## The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO System Use in Conjunction With VISITAG SURPOINT Module for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation. - NCT ID: NCT06324201 - Study ID: QDOT PAS - Status: RECRUITING - Start Date: 2024-02-27 - Completion Date: 2028-03 - Lead Sponsor: Heart Rhythm Clinical and Research Solutions, LLC ### Study Description Observational, multi-center, non-randomized, post-market study. This is a nested sub-study of the REAL AF Registry. Consecutive symptomatic drug refractory paroxysmal atrial fibrillation (PAF) patients from the registry will be screened for enrollment to this sub-study per inclusion and exclusion criteria. ### Conditions - Paroxysmal Atrial Fibrillation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ablation Procedure ### Outcomes Primary Outcomes - Safety of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module - Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 12-months. - Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 24-months. - Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 36-months. Secondary Outcomes ### Location - Facility: Centra Health, Inc.dba Stroobants Cardiovascular Center, Lynchburg, Virginia, 24501, United States @@
## Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11) - NCT ID: NCT06324188 - Study ID: EASThigh-AFNET 11 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2030-05 - Lead Sponsor: Atrial Fibrillation Network ### Study Description EASThigh-AFNET 11 is an international, prospective, randomized, open, blinded endpoint assessment, multicenter trial (Treatment Strategy trial).The objective of EASThigh-AFNET 11 is to investigate whether early atrial fibrillation ablation in patients with atrial fibrillation (AF) and a high comorbidity burden (CHA2DS2-VASc ≥4) reduces cardiovascular events (stroke, cardiovascular death, or heart failure events) compared to usual care. ### Conditions - Atrial Fibrillation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Early atrial fibrillation ablation - Usual Care ### Outcomes Primary Outcomes - Composite of cardiovascular complications related to AF - The primary safety outcome is a composite of all-cause death and serious complications of AF therapy. Secondary Outcomes - Number of nights spent in hospital - Time from randomisation to first occurrence of each of the individual components of the primary outcome - All-cause death - Serious adverse events related to AF therapy - Time from randomisation to first cardiovascular hospitalisation - Number of cardiovascular hospitalisations (over-night stay) - Changes in left ventricular ejection fraction - Changes in quality of life - Changes in quality of life - Changes in cognitive function - Cardiac rhythm status - AF pattern - Time from randomisation to first clinical recurrence of AF - Time from randomisation to first progression of AF ### Location - Facility: Several sites, Multiple Locations, N/A, N/A, Australia @@
## Spatial Radiogenomics of Ovarian Cancer: Implementation of a Lesion-specific 3D-printed Mould Pipeline in the Clinical Workflow for Image-guided Tissue Multi-sampling of Ovarian Tumours - NCT ID: NCT06324175 - Study ID: 6353 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2026-12-31 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description The biological spatial and temporal heterogeneity of High Grade Serous Ovarian Carcinoma (HGSOC) severely impacts the effectiveness of therapies and is a determinant of poor outcomes.Current histological evaluation is made on a single tumour sample from a single disease site per patient thus ignoring molecular heterogeneity at the whole-tumour level, key for understanding and overcoming chemotherapy resistance. Imaging can play a crucial role in the development of personalised treatments by fully capturing the disease's heterogeneity.Radiomics quantify the image information by capturing complex patterns related to the tissue microstructure. This information can be complemented with clinical data, liquid biopsies, histological markers and genomics ("radiogenomics") potentially leading to a better prediction of treatment response and outcome. However, the extracted quantitative features usually represent the entire tumour, ignoring the spatial context.On the other hand, radiomics-derived imaging habitats characterize morphologically distinct tumour areas and are more appropriate for monitoring the changes in the tumour microenvironment over the course of therapy. In order to successfully incorporate the habitat-imaging approach to the clinic, histological and biological validation are crucial. However, histological validation of imaging is not a trivial task, due to issues such as unmatched spatial resolution, tissue deformations, lack of landmarks and imprecise cutting. Patient-specific three-dimensional (3D) moulds are an innovative tool for accurate co-registration between imaging and histology. The aim of this study is to optimize and integrate such an automated computational 3D-mould co-registration approach in the clinical work-flow in patients with HGSOC. The validated radiomics-based tumour habitats will also be used to guide tissue sampling to decipher their underlying biology using genomics analysis and explore novel prediction markers. ### Conditions - Ovarian Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Implementation of the 3D printing pipeline in the clinical setting for recurrent HGSOC Secondary Outcomes - Biological validation of spatial radiomics in HGSOC ### Location - Facility: Advanced Radiology Center, Roma, N/A, 00168, Italy @@
## Does the Pain Experienced During Orthodontic Treatment and Bracket Removal Depend on the Architecture of the Bracket? - NCT ID: NCT06324162 - Study ID: JagiellonianU Gibas-Stanek - Status: COMPLETED - Start Date: 2021-10-01 - Completion Date: 2023-05-01 - Lead Sponsor: Piotr Fudalej ### Study Description The present research aimed to thoroughly investigate the impact of bracket architecture on pain perception during active treatment, debonding, and adhesive removal. ### Conditions - Debonding - Orthodontic Brackets ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - bracket removal pliers, LODI ### Outcomes Primary Outcomes - Pain during active treatment - Pain during brackets removal - Pain on adhesive removal Secondary Outcomes ### Location - Facility: Jagiellonian University Collegium Medicum, Kraków, N/A, 31-008, Poland @@
## Age-related Conditions in the Context of Multimorbidity and Frailty: Relative Weight of Frailty in Determining the Course and Outcomes of Different Chronic Diseases and Viceversa - NCT ID: NCT06324149 - Study ID: AGE-IT-FRAILTY - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-04-30 - Lead Sponsor: IRCCS San Raffaele ### Study Description Observational study. Participants of the FRASNET study (9th March 2017, Protocol No. 24/INT/2017) who were evaluated in 2016 and 2017 will be contacted to be re-evaluated with multidimensional visits as part of the present study in order to assess trajectories and biomarkers of frailty and sarcopenia. Moreover, are going to evaluate with the same multidimensional visits patients with mild cognitive impairment and dementia followed up at the Neurologic Unit of the San Raffaele Hospital. ### Conditions - Frailty - Sarcopenia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - completion of scales and questionnaires; venous blood sampling; muscle ultrasound; cardiac ultrasound; electrocardiogram; bioelectrical impedance analysis ### Outcomes Primary Outcomes - identify new molecular markers of frailty and sarcopenia Secondary Outcomes - evaluate the ability of new markers for frailty, sarcopenia, cognitive impairment ### Location - Facility: San Raffaele Hospital, Milan, N/A, N/A, Italy @@
## Validation, Implementation, and Cost-analysis of a Strategy for Personalized Diagnosis of Rare Kidney Diseases - NCT ID: NCT06324136 - Study ID: KIDNEY-PNRR - Status: RECRUITING - Start Date: 2023-07-06 - Completion Date: 2026-12-30 - Lead Sponsor: Meyer Children's Hospital IRCCS ### Study Description Chronic kidney disease (CKD) affects about 10% of the world population, with high morbidity and mortality. Genetic kidney diseases are increasingly recognized across all age groups and represent over 20% of all the causes of CKD. Accurate diagnosis allows necessary and unnecessary diagnostic procedures to be defined, avoids unnecessary treatments, improves prognosis prediction, identifies other family members for genetic counseling, and defines risks for living donor kidney transplantation. The research group coordinated by the Principal Investigator has recently developed an algorithm for the genetic diagnosis in pediatric and adult patients with CKD. The application of this personalized diagnostic algorithm on a local study led to a global diagnostic yield of 70%, suggesting that this strategy has the potential to substantially improve the diagnostic approach to patients with rare kidney disorders. The aim of this study is to validate and implement these results by extending its application in a multicentric study involving nephrology units that are referral centers for rare kidney diseases at national level. ### Conditions - Chronic Kidney Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Implementation of the diagnostic algorithm ### Outcomes Primary Outcomes - Implementation of a diagnostic algorithm for personalized diagnosis of rare kidney diseases Secondary Outcomes - Analysis of the functional role of variant of unknown clinical significance (VUS) - Identification of immunological and/or structural factors in genetic and nongenetic forms. - Cost-effectiveness of the diagnostic algorithm. ### Location - Facility: Meyer Children's Hospital IRCCS, Firenze, N/A, N/A, Italy @@
## Observational Study Aimed at Evaluating the Trend of Neuropathic Pain - NCT ID: NCT06324123 - Study ID: 23C304 - Status: RECRUITING - Start Date: 2023-06-09 - Completion Date: 2024-12-31 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description The present study aims to evaluate the trend of neuropathic pain in patients treated with Peacetil for a period of two months.Neuropathic pain will me assessed through the Numeric Rating Scale (NRS) questionnaire score. ### Conditions - Neuropathic Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Peacetil ### Outcomes Primary Outcomes - Change in neuropathic pain after two months of treatment with Peacetil Secondary Outcomes - Change in neuropathic pain after one month of treatment with Peacetil ### Location - Facility: Istituto Auxologico Italiano, Milan, Lombardy, 20149, Italy @@
## Evaluating the Impact of Centralized Interventions on Lung Cancer Screening Adherence in Community Settings, ACCELL Trial - NCT ID: NCT06324110 - Study ID: RG1124119 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2027-06-30 - Lead Sponsor: Fred Hutchinson Cancer Center ### Study Description This clinical trial tests the impact of lung cancer screening care coordination interventions implemented at the system-level on lung cancer screening adherence in community settings. Lung cancer remains the leading cause of cancer death in the United States. Although lung cancer screening (LCS) with yearly low-dose chest computed tomography has the potential to decrease lung deaths, the use of this screening technique remains low. In addition, studies have shown that adherence to lung cancer screening in clinical settings is far lower that those found in clinical trials. Improved care coordination services that include comprehensive, system-wide tracking of screening outcomes for all LCS participants, results reporting with direct-to-patient information, direct patient and physician communication, and active reviews of non-adherent patients and stepped support interventions may increase patient adherence to LCS. Coordination services at the system-level may decrease barriers and improve adherence to lung cancer screening in community settings. ### Conditions - Lung Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Electronic Health Record Review - Interview - Patient Navigation ### Outcomes Primary Outcomes - Adherence to appropriate follow-up Secondary Outcomes - Characteristics associated with adherence to follow up ### Location - Facility: Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, 98109, United States @@
## Diagnostic Value of Endocytoscopy for Colorectal Lesions - NCT ID: NCT06324097 - Study ID: 2024-357 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-05 - Lead Sponsor: Hong Xu ### Study Description Colorectal cancer (CRC) is the third most common malignancy and the second leading cause of cancer-related death worldwide. Colonoscopy is considered the preferred method of screening for colorectal cancer, and resection of colorectal lesions can significantly reduce the incidence and mortality of colorectal cancer. In order to improve the qualitative and quantitative diagnosis of colorectal lesions, many endoscopic techniques, such as image-enhanced endoscopy (IEE), including narrowband imaging (NBI), magnifying endoscopy, pigment endoscopy, confocal laser endoscopy, and endocytoscopy (EC) are applied clinically. The application of EC is intended to achieve the purpose of real-time histopathological endoscopic diagnosis without biopsy. Several studies have shown that EC is effective in identifying the nature of colorectal lesions and judging the depth of invasion in CRC. Based on the endoscopic diagnosis, the endoscopist can determine the treatment plan for the colorectal lesions. The latest EC is an integrated endoscope with a contact light microscopy system with a maximum magnification of 520 x. EC may demonstrate the atypical of gland structure and cells after staining (EC staining mode, along with the use of the EC-NBI mode. The endoscopic diagnosis of the EC staining mode is based on the EC classification (EC-C), used to predict the histopathological diagnosis of colorectal lesions. A prospective randomized trial showed that the diagnostic accuracy was 94.1% by EC-C. However, the diagnostic value of EC-C depends on the operator and may be influenced by the quality of the staining. Meanwhile, the high-quality staining process is time-consuming and tedious. Therefore, EC-NBI seems to be the first choice for EC diagnosis with the advantages of convenient operation and efficient diagnosis. EC-NBI can display the super-amplified surface microvessels of the lesion and provide pathological prediction according to the vessel classification (EC-V). EC-V achieved 99% diagnostic accuracy for hyperplastic polyps and 88.6% for invasive carcinoma. In EC examination, the investigators usually use EC-NBI and EC staining successively to diagnose colorectal lesions, which is believed to improve the diagnostic performance. However, the diagnostic value of increasing EC-staining after EC-NBI examination for predicting the pathological nature of colorectal lesions is still unclear. Therefore, this retrospective study aimed to evaluate the diagnostic value of two different modalities of cell endoscopy for colorectal lesions and to clarify whether additional EC staining after EC-NBI could improve the diagnostic performance of predicting the pathological diagnosis of colorectal lesions.In the study, the investigators collect clinical information of colorectal lesions which were diagnosed by endoscopic diagnosis (including EC-NBI and EC-staining) and pathological diagnosis. Then, the investigators calculate the accuracy, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and high confidence diagnosis rate of EC-C and EC-V classification, respectively. Inter-and intra-observer agreement in the diagnosis of EC-C and EC-V will be calculated. ### Conditions - Colorectal Neoplasms ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - endocytoscopy ### Outcomes Primary Outcomes - sensitivity - specificity - accuracy - positive predictive value - negative predictive value Secondary Outcomes - inter-observer agreement - intra-observer agreement ### Location - Facility: the Department of Gastroenterology and Endoscopy Center, First Hospital of Jilin University, Changchun, Jilin, 130021, China @@
## PATHophysiology of OSteoporosis: Role of Hidden Cortisol Excess and Its Predictors in Bone Fragility - NCT ID: NCT06324084 - Study ID: 05M201 - Status: RECRUITING - Start Date: 2023-04-24 - Completion Date: 2025-04-24 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description Osteoporosis is a chronic skeletal disease which leads to a decrease in bone strength which increases the risk of fractures.Clinically overt hypercortisolism leads to hypertension, central obesity, diabetes and osteoporosis. More recently, even the condition of mild and asymptomatic hypercortisolism has been associated with increased prevalence of chronic complications of cortisol excess and mortality. In patients with osteoporosis this form of hypercortisolism may remain occult (hidden hypercortisolism, HidHyCo).Although asymptomatic, however, this subtle cortisol excess is associated with an increased risk of osteoporosis and fragility fractures.Moreover, HidHyCo prevalence seems to be increased in osteoporotic patients. The HidHyCo case finding is of utmost importance. However, given the high prevalence of bone fragility and the relatively low diagnostic accuracy of the currently available tests for the HidHyCo detection, a mass screening for HidHyCo is considered unthinkable. As now, no guidelines are available for addressing the HidHyCo screening in osteoporosis.Therefore, the aims of the present study are the following: i) to assess the HidHyCo prevalence in a sample of osteoporotic patients; ii) to compare the clinical characteristics between osteoporotic/osteopenic patients with HidHyCo and those without HidHyCo in order to determine the clinical characteristics more frequently associated with the HidHyCo presence and to identify those osteoporotic patients worthy of HidHyCo screening; iii) to further investigate bone quality and turnover in HidHyCo patients, to characterize HidHyco patients from a molecular and genetic point of view and to evaluate the pathogenetic mechanisms explaining the negative effects of endogenous cortisol excess on bone health in these patients and the potential role of the genetic background and of the gut microbiome.The HidHyCo could be present in a not negligible percentage of osteopenic/osteoporotic patients. In these patients, osteoporosis and, if present, other comorbidities can improve by the surgical resection of the adrenal or pituitary adenoma if feasible, or by the use of drugs able to modulate cortisol secretion or glucocorticoid sensitivity. Moreover, the case-finding could be reserved in those patients at higher risk of having HidHyCo, therefore, reducing the costs of a scarcely specific mass screening. ### Conditions - Osteoporosis - Bone Fracture - Cortisol Excess ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Prevalence of hidden hypercortisolism in osteoporosis - Statistical comparison of the clinical and biochemical characteristics of osteoporotic/osteopenic patients with HidHyCo and those without HidHyCo to identify the characteristics predictive of the presence of HidHyCo in osteoporosis Secondary Outcomes - Further investigation of bone turnover in HidHyCo patients, as assessed by serum osteocalcin, CrossLaps, bone alkaline phosphatase and amino-terminal propeptide of type 1 procollagen (P1NP) and additional new potential serum markers of bone status. - Further investigation of bone quality as assessed by Radiofrequency Echographic Multi Spectrometry (REMS) - Characterization of HidHyco patients from a molecular and genetic point of view by the determination of circulating microRNAs, peripheral glucocorticoid activity and the polymorphic variants of the 11ßHSD1, GR and B2AR gene. - Assessment of gut microbiome composition by the analysis of fecal samples ### Location - Facility: Azienda Ospedaliera Universitaria Policlinico "G. Rodolico-San Marco", Catania, N/A, N/A, Italy @@
## Study to Verify the Efficacy of a Product Containing 125 mg of TetraSOD® for the Treatment of Male Infertility - NCT ID: NCT06324071 - Study ID: 2022_TSOD_125 - Status: RECRUITING - Start Date: 2024-01-08 - Completion Date: 2025-04 - Lead Sponsor: Fitoplancton Marino, S.L. ### Study Description TetraSOD® is a unique marine phytoplankton (Tetraselmis chuii) SOD-rich ingredient that is grown under patent-protected technology exclusively designed by the company Fitoplancton Marino, S.L. (Spain). In a previous pilot trial, the ability of TetraSOD® (dose: 250 mg/day) to improve semen characteristics in idiopathic infertile men after three months of treatment was assessed, revealing significant improvements in almost all of the analyzed parameters. In a further clinical trial close to finish (ClinicalTrials.gov Identifier: NCT04864314) using the same dose, such positive results have been tested again in a higher number of patients, and additional parameters have been included in order to gain insights into the sperm physiological changes that underpin the improvement in semen quality. In this new clinical trial, an intermediate dose (125 mg/day) is going to be tested in an attempt to determine a range of TetraSOD® dosage being clinically active for the treatment of male infertility. ### Conditions - Male Infertility ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Sham - Marine microalgae Tetraselmis chuii with high Superoxide Dismutase (SOD) activity ### Outcomes Primary Outcomes - Sperm motility - Sperm concentration - Sperm oxidative stress Secondary Outcomes - DNA integrity - sORP by MiOXSYS - Adverse effects ### Location - Facility: Hospital Clinic, Barcelona, N/A, 08036, Spain @@
## Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC - NCT ID: NCT06324058 - Study ID: Huashan_H - Status: NOT_YET_RECRUITING - Start Date: 2024-03-18 - Completion Date: 2026-03-18 - Lead Sponsor: Huashan Hospital ### Study Description This trial plans to enroll 190 eligible patients and randomize them into two groups with a 1:1 ratio, with 95 patients in each group. The experimental group will receive immediate cryoablation therapy at the resection site after TUR, while the control group will only undergo TUR and receive conventional BCG instillation therapy postoperatively. Both groups of subjects will undergo Re-TURBT or cystoscopy 10-12 weeks after surgery to compare the tumor-free residual rates and adverse events between the two groups. ### Conditions - Bladder Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Transurethral cryoablation - Transurethral resection of bladder tumor - Bcg Intravesical ### Outcomes Primary Outcomes - Tumor residual rate Secondary Outcomes - Recurrence - Progression ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Deprescribing Intervention for Patients With Chronic Kidney Disease - NCT ID: NCT06324045 - Study ID: MRC-01-22-314 - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2025-08-31 - Lead Sponsor: Hamad Medical Corporation ### Study Description Chronic Kidney Disease (CKD) is recognized as a leading health problem globally. It is associated with multiple consequences such as cardiovascular diseases, infections, reduced cognitive function, and higher mortality rates. In Qatar, it is estimated that 13% of the population suffers from CKD. Management of CKD is associated with polypharmacy (the use of multiple medications), which burdens the patients and leads to adverse health and economic outcomes. As documented by previous studies, CKD setting is associated with a high medication burden, which leads to non-adherence, reduced quality of life, and other negative sequelae. These consequences can be minimized or averted by implementing a deprescribing program. Deprescribing is defined as the supervised process of intentionally stopping a medication, altering the dose or introducing a safer alternative to improve a person's clinical and quality of life outcomes. Previous deprescribing initiatives in inpatient and outpatient hospital settings were successfully implemented.In general, there are limited deprescribing initiatives in CKD settings. There is a need to provide evidence of the impact of deprescribing programs on improving clinical and economic outcomes in this setting. In Qatar, there is no evidence of the effectiveness of implementing deprescribing programs in clinical settings. Therefore, we have built a team of researchers, clinicians, and stakeholders, and initiated a collaboration with deprescribing experts to fit into the Qatar healthcare system. This project aims to initiate a deprescribing multidisciplinary team and to evaluate the impact of providing such services on the clinical and economic outcomes among CKD patients in Qatar using a randomized controlled trial approach. The findings could have a potential positive impact on the professional practice and patient safety represented by health and economic outcomes. ### Conditions - Chronic Kidney Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Deprescribing ### Outcomes Primary Outcomes - Percentage of participants with at least one Potentially inappropriate medications (PIMs) - Number of Potentially inappropriate medications (PIMs) Secondary Outcomes - Pill burden - Health-related quality of life (HRQoL) - Treatment burden - Self-reported adherence - Medication Refills adherence - Emergency department visits and hospitalizations - Unanticipated adverse effects - Cost avoidance - Cost savings ### Location - Facility: Hamad Medical Corporation, Doha, Unlisted (UL), 00000, Qatar @@
## SUNNYDAY: SUbepithelialgastroiNtestiNal Tumors Detection,accuracYDiAgnosis,ElastographY and Contrast-enhanced EUS - NCT ID: NCT06324032 - Study ID: 021-FPO20 - Status: RECRUITING - Start Date: 2020-12-17 - Completion Date: 2025-12-31 - Lead Sponsor: Fondazione del Piemonte per l'Oncologia ### Study Description This will be a longitudinal, prospective, observational multicenter study where the role of EUS-E will be examined in differentiating subepithelial gastrointestinal tumors in 138 patients ### Conditions - Subepithelial Gastrointestinal Tumors ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - EUS Elastography (EUS-E) ### Outcomes Primary Outcomes - Evaluation of EUS-E accuracy qualitative - Evaluation of EUS-E accuracy quantitative Secondary Outcomes - Evaluation of diagnostic accuracy of EUS-biopsy with fine needle biopsy (FNB) - Evaluation of gene mutations in EUS-guided specimen - Correlation of elastographic and contrastographic characteristics of SETs with the pathological risk stratification. - Complication rate (perforations, bleeding) of the procedure ### Location - Facility: Ospedale Santa Maria della Scaletta, Imola, Bologna, N/A, Italy @@
## Gynaecological Examination Gown and Patient Satisfaction - NCT ID: NCT06324019 - Study ID: Ethics number E.405221 - Status: COMPLETED - Start Date: 2022-02-01 - Completion Date: 2022-06-22 - Lead Sponsor: ayşegül muslu ### Study Description The attitude of the health personnel before, during and after the examination and the positive examination experience of the person have a significant impact on ensuring the continuity of the subsequent examination and increasing the quality of the service provided. The use of different clothes in the patient during the examination will ensure that the patient\'s physical privacy is ensured from the moment of application, during diagnosis and treatment, and that the examination experience will be positively affected by preventing the use of additional covers to protect the privacy of all patients during examination and intervention. This will contribute to the maintenance of health by eliminating the intense stress and embarrassment experienced by patients during the examination and ensuring that they regularly attend health checks. In addition, meeting the privacy expectations of the patients will ensure that they are satisfied with the health service they receive, thus increasing the quality of the health service provided.The attitude of the health personnel before, during and after the examination and the positive examination experience of the person have an important effect on ensuring the continuity of the subsequent examination and increasing the quality of the service provided. With the examination suit, it will be ensured that the patient\'s bodily privacy is ensured from the moment of application, during diagnosis, treatment and care, the use of the same cover to protect the privacy of all patients during examination and intervention will be prevented to prevent infection transmission and the examination experience will be positively affected. Thus, the intense stress and embarrassment experienced by patients during the examination will be eliminated and will contribute to the maintenance of health through regular visits to health checks. In addition, meeting the privacy expectations of patients will ensure that they are satisfied with the health service they receive, thus increasing the quality of the health service provided. In order to ensure patient privacy, to protect and improve women\'s health and to provide convenience in gynecological examination, the gynecological examination garment to be used in the examination can be designed as disposable, perineum and thigh open for the examination to be performed. In order to protect privacy, extra parts can be used to ensure that the open parts remain closed outside the examination process. Properties of the fabric used in the examination garment;* Grama: 32,07 g/m\^2* Explosion.: 135,77 kpç* Detachment: Ȼ: 115NȺ: 120 N* Air permeability: 1750* Type of material: PolypropyleneThe study was carried out as a post-test control group design from randomised controlled studies. The intervention group of the study was dressed in gynaecological examination clothes, while the control group used the drape given to the patient during the examination, which is a routine practice in the health institution where the study was conducted. ### Conditions - Gynecology - Gynecology/Obstetrics Conditions ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - putting on an examination gown ### Outcomes Primary Outcomes - Gynaecological examination gown Secondary Outcomes ### Location - Facility: EGE, İzmir, Konak, N/A, Turkey @@
## A Phase 1 Trial of LIB-01 in Healthy Participants. - NCT ID: NCT06324006 - Study ID: DCT3934 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-08-25 - Completion Date: 2024-05-30 - Lead Sponsor: Dicot AB ### Study Description The goal of this clinical trial is to learn about the safety, tolerability and pharmacokinetics of LIB-01 in healthy male participants. The main questions it aims to answer are:* How safe and tolerable is LIB-01 when given once or repeatedly at different dose levels.* What are the pharmacokinetic characteristics of LIB-01Participants will receive LIB-01 and be followed up for safety and pharmacokinetics by:* Adverse events* ECG* Blood sampling for laboratory parameters and pharmacokinetic analysis ### Conditions - Erectile Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - LIB-01 - Placebo ### Outcomes Primary Outcomes - To evaluate the incidence of treatment-emergent adverse events as assessed by CTCAE in healthy male participants, following a single oral dose of LIB-01. - To evaluate changes in vital signs in healthy male participants, following a single oral dose of LIB-01. - To evaluate changes in ECG in healthy male participants, following a single oral dose of LIB-01. - To evaluate the incidence of treatment-emergent adverse events as assessed by CTCAE in healthy male participants, following multiple oral dosing of LIB-01. - To evaluate changes in vital signs in healthy male participants, following a multiple oral dosing of LIB-01. - To evaluate changes in ECG in healthy male participants, following multiple oral dosing of LIB-01. Secondary Outcomes - To characterise the maximum plasma concentration of LIB-01, following a single oral dose. - To characterise the plasma concentration half life of LIB-01, following a single oral dose. - To characterise the plasma concentration area under curve of LIB-01, following a single oral dose. - To characterise the maximum plasma concentration of LIB-01 following multiple oral dosing. - To characterise the plasma concentration half life of LIB-01 following multiple oral dosing. - To characterise the plasma concentration half life of LIB-01 following multiple oral dosing. ### Location - Facility: Clinical Trial Consultants, Uppsala, N/A, 75237, Sweden @@
## The Effect of Different Window-preparation Approaches on the Clinical Outcomes of Lateral Sinus Floor Elevation - NCT ID: NCT06323993 - Study ID: 2021-115 - Status: COMPLETED - Start Date: 2022-03-01 - Completion Date: 2023-06-15 - Lead Sponsor: The Dental Hospital of Zhejiang University School of Medicine ### Study Description This study retrospectively evaluated the effect of two different lateral window preparation techniques on peri-implant bone augmentation for patients who underwent lateral sinus floor elevation with simultaneous implant placement using two-dimensional and three-dimensional radiographic results, with special emphasis placed on the stability of the graft material after surgery. ### Conditions - Dental Implantation - Cone-Beam Computed Tomography - Surgical Procedure, Unspecified - Maxillary Sinus Floor Augmentation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Piezoelectric osteotomy ### Outcomes Primary Outcomes - Apical bone height - Endo-sinus bone gain - Palatal bone height - Buccal bone height - Augmentation volume Secondary Outcomes - Perforation incidence - Early implant loss - Lateral window length - Lateral bone length ### Location - Facility: Stomatology Hospital, School of Stomatology, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310000, China @@
## INHANCE Stemless Reverse Shoulder IDE - NCT ID: NCT06323980 - Study ID: DSM202108 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-15 - Completion Date: 2028-04-10 - Lead Sponsor: DePuy Orthopaedics ### Study Description 2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder. ### Conditions - Arthroplasty - Replacement - Shoulder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Reverse Total Shoulder ### Outcomes Primary Outcomes - Constant Murley Score (CMS) - Removal of any system component - Revision of any system component - Reoperation of any system component - Supplemental Fixation of any system component - Radiolucent Lines (Humeral & Glenoid) - Migration and Tilt (Humeral & Glenoid) Secondary Outcomes - Constant Murley Score (CMS) - EQ-5D-5L and EQ-VAS - Simple Shoulder Test - Single Assessment Numeric Evaluation (SANE) Score - Survivorship - Complications ### Location - Facility: Hoag Orthopedic Institute, Irvine, California, 92618, United States @@
## Growing Strong Study of Unconditional Cash Transfers Plus Peer Support for Families With Babies in Homeless Shelters - NCT ID: NCT06323967 - Study ID: 231981 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-03 - Lead Sponsor: Vanderbilt University ### Study Description The Growing Strong program tests a novel approach to helping families with young children living in homeless shelters, namely offering guaranteed, unconditional cash gifts that families can use as they wish plus voluntary peer support. The assumption behind this approach is that families know best how to allocate resources to meet their own individual needs. While there are a number of Direct Cash Transfer studies taking place around the country, the investigator(s) are unaware of any that have tested the relationship of receiving cash on homelessness among families specifically. To be eligible to participate in the study, families must reside in a homeless shelter and have at least one child under two years of age living with them in shelter. The investigator(s) have tied eligibility to the age of the youngest child in the household because rates of shelter use are highest among this population and because the costs associated with young children increase such families' financial burdens.A total of 200 families will be enrolled in the study. One hundred families in the active intervention group will receive $1,500 per month ("substantial cash") for 24 months ($18,000 annually) and may also elect to receive peer support services. One hundred families in the active comparison group will receive $50 per month ("nominal cash") for 24 months ($600 annually) and will not have access to the peer support services. A third, passive comparison group will receive usual care within the homeless shelter system in the same metropolitan area (New York City) as participants in both cash gift groups. This group of families will be followed only in administrative records.The main research questions are: does providing substantial, unconditional cash transfers plus access to voluntary peer support services over 24 months a) reduce the length of time in shelter for families with young children and/or b) improve other aspects of family and child well-being relative to providing nominal cash transfers alone or usual care. ### Conditions - Time to Shelter Exit - Family Well-being - Child Well-being ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Large unconditional cash transfers plus voluntary peer support. - Nominal cash transfers - Passive comparison group ### Outcomes Primary Outcomes - Time to shelter exit Secondary Outcomes - Housing: Total time in shelter* - Housing: Housing Stability - Target Child Development: Child Behavior Problems* - Target Child Development: Child Prosocial Behavior* - Target Child Development: Child Verbal Development - Parenting: Chaos in the Home* - Parenting: Early Learning Activities with Target Child* - Parenting: Target-Child-Focused Expenditure Index - Parenting: Household Routines - Parenting: Parenting Stress - Family Separation: Separation of Parent and Target Child (Cumulative at any time point)* - Family Separation: Indicated Investigations, Preventive services, or Child Placement of Target Child by Child Protective Services (No/Yes) - Adult Well-Being: Adult Psychological Distress* - Adult Well-Being: Adult Alcohol or Drug Abuse - Adult Well-Being: Hope - Domestic Violence: Adult Domestic Violence* - Financial Well-Being: Food Insecurity* - Financial Well-Being: Adult Economic Stress - Financial Well-Being: Financial Well-Being as Measured by the Consumer Financial Protection Bureau Financial Well-Being Scale - Financial Well-Being: Financial Hardship as Measured by the Urban Institute Well-Being and Basic Needs Survey - Employment: Income from Employment in Most Recent Period* - Employment: Adult Work for Pay - Health Care: Family Use of Emergency Medical Care or Hospitalization (Cumulative at any point)* - Health Care: Proportion of Target Child Immunizations Recommended by Age by the American Academy of Pediatrics - Health Care: Proportion of Well-Child Visits by Target Child Recommended by Age by the American Academy of Pediatrics ### Location - Facility: Win NYC Shelter System, New York, New York, 10004, United States @@
## tVNS During Motor Training in Older Adults - NCT ID: NCT06323954 - Study ID: H24110 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2026-06-30 - Lead Sponsor: Georgia Institute of Technology ### Study Description The goal of this study is to learn about the effect of applying transcutaneous vagus nerve stimulation (tVNS) during motor training on motor learning in older adults. The main question it aims to answer is whether applying tVNS after successful motor trials (post-success tVNS) will facilitate the rate of motor learning. Participants will be randomly assigned to tVNS or sham group and receive tVNS or sham, respectively, at the outer ear during finger control training sessions. Finger control performance will be tested before and after the training sessions without outer ear stimulation. ### Conditions - Older Adults ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - tVNS stimulation - Sham stimulation ### Outcomes Primary Outcomes - Rate of error reduction Secondary Outcomes ### Location - Facility: Human Neuromuscular Physiology Lab, Atlanta, Georgia, 30332, United States @@
## Motor Imagery and Isometric Exercises on Pelvic Floor Sensorimotor Condition - NCT ID: NCT06323941 - Study ID: UV0003 - Status: COMPLETED - Start Date: 2023-11-01 - Completion Date: 2024-03-14 - Lead Sponsor: University of Valencia ### Study Description Mental practice (both in isolation and also in combination with real practice) has been shown to improve somatosensory and motor variables but so far no study has taken it into the study of women's health. Through the present study the investigators want to offer some interesting data regarding the effectiveness of mental practice combined with physical practice. ### Conditions - Isometric Exercise - Motor Imagery - Women's Health ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Motor Imagery plus therapeutic exercise - Therapeutic exercises ### Outcomes Primary Outcomes - Skin conductance (for asessing electrodermal activity) Secondary Outcomes - Algometry for assessing pressure pain thresholds (Pain sensitivity) - maximal pelvic floor muscle strength (measured in grams and with the phenix device) ### Location - Facility: Ferran Cuenca Martínez, Valencia, N/A, 46017, Spain @@
## A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments - NCT ID: NCT06323928 - Study ID: 20297A - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-09-30 - Lead Sponsor: H. Lundbeck A/S ### Study Description The purpose of this trial is to determine which doses of Lu AG09222 are recommended to help prevent migraines. People who join this trial have already tried 2 to 4 other available medications to prevent their migraines, but these medications have not helped them. ### Conditions - Migraine ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Lu AG09222 - Placebo ### Outcomes Primary Outcomes - Change From Baseline in the Number of Monthly Migraine Days (MMDs) Secondary Outcomes - Change From Baseline in MMDs - Percentage of Participants With ≥50% Reduction From Baseline in MMDs - Percentage of Participants With ≥75% Reduction From Baseline in MMDs - Change from Baseline in the Number of Monthly Headache Days - Number of Participants with Treatment-emergent Adverse Events (TEAEs) - Number of Participants with Anti-drug Antibodies (ADA) ### Location - Facility: Accellacare of Charleston, Mount Pleasant, South Carolina, 29464, United States @@
## Comparative Study of 3 Multifocal Intraocular Lenses in Murcia - NCT ID: NCT06323915 - Study ID: 2020_03_C3M - Status: RECRUITING - Start Date: 2021-04-20 - Completion Date: 2025-09-20 - Lead Sponsor: Cristalens Industrie ### Study Description The goal of this clinical trial is to compare the performance of 3 intraocular lenses (IOLs): FineVision (comparator), ARTIS SYMBIOSE (study lenses), and Tecnis Synergy (comparator) through binocular distance-corrected defocus curve.This main objective will be to show superiority of the ARTIS SYMBIOSE system through binocular distance-corrected defocus curve.The patient population to be included is patient suffering from cataract who requires cataract surgery procedure that meet the inclusion and non-inclusion criteria and provide written informed consent.Participants will attend a total of 5 study visits: 1 preoperative visit, 1 surgery visit and 3 postoperative visits. ### Conditions - Cataract ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - intraocular lens implantation in cataract surgery ### Outcomes Primary Outcomes - defocus curve comparison Secondary Outcomes ### Location - Facility: Vista Clinic Ircovision Murcia, Murcia, N/A, 30008, Spain @@
## Autologous Platelet-rich Plasma as a Treatment for Macular Holes - NCT ID: NCT06323902 - Study ID: PT-CO39 - Status: COMPLETED - Start Date: 2022-10-25 - Completion Date: 2024-02-29 - Lead Sponsor: Clinica Oftalmologica Paredes ### Study Description For a series of patients with full-thickness macular hole, an autologous plasma rich in growth factors was developed in the form of a clot and applied to the retinal defect. These patients were followed up for a period of one year, obtaining substantial improvement both anatomically and functionally. ### Conditions - Macular Holes - Macular Hole of Left Eye (Disorder) - Macular Hole of Right Eye (Disorder) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Pars plana vitrectomy, with or without epiretinal membrane peeling, plus PRGF membrane implantation ### Outcomes Primary Outcomes - Macular hole closure Secondary Outcomes ### Location - Facility: Clinica Ofalmologica Paredes, Pasto, Nariño, 520002, Colombia @@
## Longitudinal Monitoring During Intermittent Fasting Protocols in Obese Adults - NCT ID: NCT06323889 - Study ID: LIMITFOOD2 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2027-01 - Lead Sponsor: University of Zurich ### Study Description LIMITFOOD2 is a randomized clinical intervention study that investigates the effects of two different intermittent fasting protocols compared to a control group on the health of obese adults. A total of 90 participants will be randomized into three equally sized groups: a modified alternate day fasting, a time-restricted eating and a control group, receiving general weight-loss counseling. ### Conditions - Intermittent Fasting - Obesity - Time Restricted Eating ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Modified Alternate Day Fasting - Time-Restricted Eating - Weight-loss counseling ### Outcomes Primary Outcomes - Fat Volume Secondary Outcomes - Distribution of fat volume - Concentration of Leptin - Changes in Insulin Sensitivity - Changes in Fasting Lipids - Changes in Inflammatory Markers - Free triiodothyronine (fT3) ### Location - Facility: Department of Endocrinology, Diabetology and Clinical Nutrition, Zürich, N/A, 8091, Switzerland @@
## The Role of Quantitative CT and Radiomic Biomarkers for Precision Medicine in Pulmonary Fibrosis - NCT ID: NCT06323876 - Study ID: HSR301252 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2029-05 - Lead Sponsor: University of Virginia ### Study Description This observational study involves obtaining 2 chest CT scans; a historical baseline CT within ±1 year of enrollment into PRECISIONS, and a follow-up CT (either historical or prospective) 12 months ± 180 days after the baseline CT. Many IPF patients will have a CT scan every 12 months for disease monitoring and cancer screening. Participants will have the option to share historical CTs only or they can choose to have a research CT done for the follow-up scan, if a scan for clinical purposes is not available. ### Conditions - Idiopathic Pulmonary Fibrosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - HRCT - Blood Draw ### Outcomes Primary Outcomes - Derivation of DTA in IPF only cases from the PFF-PR and its associations with disease severity and outcomes. - Determine whether known IPF-risk genetic variants are associated with DTA score. - Identify novel genetic variants that associate with DTA score progression. - Determine if DTA or any constituent radiomic features correlate with select plasma proteins. - Determine if DTA or any of constituent radiomic features correlate with transcriptomic - Determine the best combination of markers (DTA, proteins and transcriptome) for machine learning algorithms for AUC evaluation of ROCs on all 3 cohorts. Secondary Outcomes - Determine associations of changes in DTA scores with 12-month changes in FVC and DLCO. - Determine associations of changes in DTA scores with drug treatment (i.e., antifibrotics) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Ultra-high Resolution CT: the End of Stapes Prosthesis Measurement Misestimation - NCT ID: NCT06323863 - Study ID: N°4-RCB/EUDRACT - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-12-01 - Lead Sponsor: Central Hospital, Nancy, France ### Study Description Actual CT scanners overestimate stapes piston size, and do not represent a valuable technique for their follow-up, especially in case of complication. Ultra-high resolution has not yet been evaluated in this setting. ### Conditions - Otosclerosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - stapedectomy - ultra high resolution CT ### Outcomes Primary Outcomes - length Secondary Outcomes ### Location - Facility: Chu Nancy, Nancy, N/A, 54000, France @@
## Improving Access to Community-Based Occupations Via a Rideshare Training Program - NCT ID: NCT06323850 - Study ID: HM20028878 - Status: RECRUITING - Start Date: 2024-05-15 - Completion Date: 2025-02 - Lead Sponsor: Virginia Commonwealth University ### Study Description Community mobility is critical for living independently and engaging in one's community. It is especially important for people in their early adult years, as this is often a time of transition to employment and living independently. Community mobility can be particularly challenging for adults with Autism Spectrum Disorders (ASD) (henceforth referred to as autistic adults based on the preferred identity-first language of our autistic partners). Some autistic adults are unable to meet the demands of driving. Public transportation is an option for autistic adults; and autistic adults are more likely to use public transportation than their non-autistic counterparts. However, using public transportation may be just as challenging as driving for the autistic population. Rideshare (also called ride-hailing) is a relatively new form of transportation in which passengers get from point A to point B in private vehicles driven by their owners. A digital app, usually accessed on a smartphone, matches passengers and drivers, coordinates routes using a GPS system, and facilitates payment through a linked financial account. Rideshare has the potential to address many of the issues autistic adults have accessing the community. It is faster and more direct than the public train or bus, there is limited social interaction required, and rides can be scheduled at any time. Despite it's potential to increase transportation in autistic adults, there are no evidence-based training programs to support Rideshare use in this population. ### Conditions - Autism ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Intervention Phase - Virtual Training Sessions - Ride-Along Training Sessions ### Outcomes Primary Outcomes - Evaluate the intervention by conducting an effectiveness-implementation waitlist-controlled trial using our Safe Rideshare Program (SRP) , evaluate autistic adults participating in the SRP intervention find the intervention acceptable? - Evaluate if the trainers conducting the SRP intervention find the intervention to be appropriate - Autistic adults who have participated in the SRP program display greater independence in using Rideshare compared to autistic adults who did not participate in the SRP program (wait-list group) - Autistic adults who have participated in the SRP program display greater safety in using Rideshare compared to autistic adults who did not participate in the SRP program (wait-list group)? Secondary Outcomes - In the wait-list group, is there a change in community engagement, social participation, and employment from the waitlist phase (no intervention) to the 2-month follow-up period (after the intervention) - How do SRP participants use of Rideshare for community, social, and/or employment activities after the intervention ### Location - Facility: Virginia Commonwealth University, Richmond, Virginia, 23298, United States @@
## Mirtazapine for the Treatment of Methamphetamine Use in Opioid Use Disorder Patients Receiving Medication Assisted Treatment - NCT ID: NCT06323837 - Study ID: 20383 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-04-01 - Lead Sponsor: Washington State University ### Study Description This project will evaluate the ability of Mirtazapine (MZP), a pharmacologically unique medication with a growing body of evidence to support its efficacy and safety for the treatment of methamphetamine (MA) use among medication for opioid use disorder (MOUD) patients, to significantly decrease MA use and related health-impairing behaviors. MZP has already successfully been used in the treatment of methamphetamine (detailed further below and in the Appendices).The investigators hypothesize that those assigned to the MZP plus treatment as usual (TAU) MZP+TAU arm will demonstrate significantly increased rates of biochemically verified abstinence from MA and other substances of abuse and experience improvements in health impairing behaviors relative to the placebo (PLO)+TAU arm across the 10-week treatment and follow-up periods. ### Conditions - Stimulant Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Mirtazapine - Placebo ### Outcomes Primary Outcomes - Urinanalysis Verified Increased Days of MA Abstinence Secondary Outcomes - Actigraphy Verified Improved Sleep Patterns ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment. - NCT ID: NCT06323824 - Study ID: 2000033271 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2029-05 - Lead Sponsor: Yale University ### Study Description The purpose of this clinical trial is to compare the effectiveness of office-based methadone with pharmacy administration and/or dispensing to office-based buprenorphine for the treatment of opioid use disorder. This study will also examine factors influencing the implementation of office-based methadone. ### Conditions - Opioid Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Methadone - Buprenorphine (BUP) ### Outcomes Primary Outcomes - Number of days of continuous treatment with study site clinician-prescribed methadone or buprenorphine, as randomized, during the 168 days post-randomization among RCT participants. Secondary Outcomes - Number of self-reported days in any FDA-approved formulation of MOUD treatment (e.g., buprenorphine, methadone or naltrexone) during the 168 days post-randomization. - Number of self-reported days in formal OUD treatment, according to American Society of Addiction Medicine (ASAM) levels of care 1-4, during the 168 days post-randomization. - Number of days prescribed any FDA-approved MOUD formulation during the 168 days post-randomization. - Number of days of self-reported non-prescribed opioid use per month. - Number of days of self-reported non-prescribed stimulant use per month. - Number of days of self-reported non-prescribed benzodiazepine use per month. - Urine toxicology - Participant satisfaction with MOUD - Total number of self-reported overdose events per total number of participant days at risk. - Total number of self-reported injection drug use related events per total number of participant days at risk. - Pain measured using PEG-3: "Pain average," "interference with Enjoyment of life," and "interference with General activity." - Number of self-reported days with acute care utilization (ED or hospitalization) events during the 168 days post-randomization per month. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of Free-breathing 3D Quantitative Perfusion in Patients With MINOCA and MINOCA-mimics - NCT ID: NCT06323811 - Study ID: COPE CMR - Status: RECRUITING - Start Date: 2023-06-15 - Completion Date: 2025-12-31 - Lead Sponsor: University of Zurich ### Study Description This clinical study examines patients presenting with acute myocardial infarction and no significant coronary artery disease on coronary angiography (MINOCA) and patients with MINOCA-mimics with advanced CMR.The present study aims to:* assess the microvascular function with a novel quantitative 3D myocardial perfusion imaging approach in the acute phase and post-convalescence* refine the role and diagnostic potential of advanced quantitative CMR imaging* assess the potential prognostic significance of microvascular dysfunction and epicardial adipose tissue on cardiovascular outcomesParticipants will undergo advanced CMR imaging in the acute setting (within 10 days after event) and post convalescence (after 3 months). ### Conditions - Myocardial Infarction With Non-Obstructive Coronary Artery - Myocarditis Acute - Takotsubo Cardiomyopathy - Spontaneous Coronary Artery Dissection - Non ST Elevation Myocardial Infarction ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - CMR ### Outcomes Primary Outcomes - Myocardial perfusion reserve index Secondary Outcomes - epicardial adipose tissue (EAT) - cardiovascular events ### Location - Facility: University Hospital Zurich, Zürich, N/A, 8091, Switzerland @@
## Diffusion Weighted MRI Enables Differential Diagnosis Between Pyocele and Mucocele - NCT ID: NCT06323798 - Study ID: 2024PI035 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-28 - Completion Date: 2024-12-28 - Lead Sponsor: Central Hospital, Nancy, France ### Study Description Diffusion MRI should allow for differentation of pus and simple retention in the paranasal sinuses, but this remained to be determined ### Conditions - Pyocele; Sinus ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - MRI ### Outcomes Primary Outcomes - apparent diffusion coefficient Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Whole-body Hyperthermia for Depression - NCT ID: NCT06323785 - Study ID: 2022-D0067 - Status: RECRUITING - Start Date: 2024-04-30 - Completion Date: 2026-03-01 - Lead Sponsor: University of Zurich ### Study Description The goal of this clinical trial is to test the efficacy of whole-body hyperthermia in major depression. The main question it aims to answer is:• Does whole-body hyperthermia alleviate symptoms of depression?Participants will be randomised to sham or active whole-body hyperthermia. The study will last 6 weeks during which five visits will take place. Depression will be measured repeatedly and biological mechanisms will be investigated. ### Conditions - Major Depressive Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Active whole-body hyperthermia - Sham whole-body hyperthermia ### Outcomes Primary Outcomes - Hamilton Rating Scale for Depression (HAMD-17; minimum: 0, maximum: 68, higher scores indicate higher depression) Secondary Outcomes - Beck Depression Inventory (BDI; minimum: 0, maximum: 63; higher scores indicate higher depression) - Medical Outcomes Study 36-item short-form health survey (MOS-SF; minimum: 0, maximum: 100, higher scores indicate better health status) - Hamilton Rating Scale for Depression (HAMD-17; minimum: 0, maximum: 68, higher scores indicate higher depression) ### Location - Facility: University of Zurich, Institute of Psychology, Zurich, N/A, 8050, Switzerland @@
## Natural History Study in Patients With PDE6A-, PDE6B- and RHO-linked Retinitis Pigmentosa - NCT ID: NCT06323772 - Study ID: RDC-RP-01 - Status: RECRUITING - Start Date: 2023-11-17 - Completion Date: 2027-03 - Lead Sponsor: University Hospital Tuebingen ### Study Description The aim of the study is to apply a novel clinical investigation protocol in patients with Phosphodiesterase 6A (PDE6A), PDE6B and Rhodopsin (RHO)-based retinitis pigmentosa. This novel, multimodal clinical examination protocol describes and correlates structural, functional and metabolic aspects during natural disease development.Test-retest variability of new measurements as well as correlations of the structural, functional, and metabolic changes will be defined to be able to define well-suited readouts for safety and efficacy of future treatment developments before they reach the clinical phase. ### Conditions - Retinitis Pigmentosa ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Optical coherence tomography (OCT) - Fundus autofluorescence imaging - Wide-field fundus photography - Adaptive optics imaging - V1 morphology (MRI) - Diffusion Tensor Imaging (DTI) - flavoprotein fluorescence (FPF) - Retinal oxymetry - Local dark adapted adaptation curves - best corrected visual acuity (BCVA) - Static cone perimetry and dark adapted perimetry - chromatic pupil campimetry (CPC) - electroretinogram (ERG) - Virtual reality (VR) functional test Secondary Outcomes ### Location - Facility: Institute for Ophthalmic Research, University Tübingen, Tübingen, Baden-Württemberg, 72076, Germany @@
## Perinatal EDucation: Pedagogical Strategy and Facilitators for the PROMotion of BreastFeeding - NCT ID: NCT06323759 - Study ID: 2022-14 - Status: COMPLETED - Start Date: 2023-02-06 - Completion Date: 2024-03-01 - Lead Sponsor: Lépine Alexandra ### Study Description Breastfeeding up to 6 months of a child's life, for its benefits to mother and child, has become a global public health goal. However, there is a disparity in the prevalence of breastfeeding (BF) in different regions of the world. According to French perinatal surveys, the rate of BF at birth decreased significantly between 2010 and 2016. Even if that figure remains stable according to the last perinatal survey in 2021, it decreases sharply, to 34.4%, at 2 months.While many plans at the national level advocate for BF, it is rare to see an action plan or an education intervention for women and couples aimed at promoting BF. However, women's needs to educate about BF and the need for professionals to reflect on their practices are highlighted by numerous perinatal surveys. It should be noted that despite the importance given to the promotion of BF found in all National Nutrition and Health Programs, none of them provide pedagogical means or an education program to achieve the objectives set. At present, in France, there is no breastfeeding education program and professionals accompany women by implementing experimental actions without considering the complexity of the promotional dimension (producing a behavioral change) and the educational dimension (understanding the pedagogy of the proposed actions) ### Conditions - Breast Feeding ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - educational intervention ### Outcomes Primary Outcomes - To find out the contribution of educational engineering to the choice and continuation of breastfeeding from the point of view of women until 4 months after the birth of the child. Secondary Outcomes - To explain contexts and generative mechanisms of pedagogical design that influence breastfeeding management up to 4 months afther birth. - To explain interactions between existing contexts, generative mechanisms and effects on women's breastfeeding management skills. - To determine contexts and generative mechanisms of pedagogical design that influence women's knowledge of breastfeeding up to 4 months afther birth. ### Location - Facility: Université Sorbonne Paris Nord - Laboratoire d'Educations et Promotion de la Santé - UR 3412, Bobigny, N/A, 93017, France @@

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