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## Behavioural Profiling of Disease-related Cognitive and Motor Impairment in PD - NCT ID: NCT06275633 - Study ID: H-18055648 - Status: COMPLETED - Start Date: 2019-03-19 - Completion Date: 2023-07-30 - Lead Sponsor: University Hospital Bispebjerg and Frederiksberg ### Study Description In this project, patients with Parkinson's Disease (PD) will be characterized by measuring cognitive and motor function and relation to effect of Levodopa.Participants will be patients with Parkinson's Disease and healthy controls. It will be investigated if there is a difference between patients with a good measured Levodopa response and with a poor measured response. ### Conditions - Parkinson Disease - Medication - UPDRS - Motor Function - Cognitive Impairment - Depression - Impulsive - Levodopa ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Levodopa ### Outcomes Primary Outcomes - Motor improvement Secondary Outcomes - Cognitive function ### Location - Facility: University Hospital Bispebjerg and Frederiksberg, Copenhagen, Region Hovedstaden, 2400, Denmark @@
## A Study Comparing Two Doses of AGTC-501 in Male Participants With X-linked Retinitis Pigmentosa Caused by RPGR Mutations (DAWN) - NCT ID: NCT06275620 - Study ID: AGTC-RPGR-001 DAWN - Status: ENROLLING_BY_INVITATION - Start Date: 2023-11-14 - Completion Date: 2029-08 - Lead Sponsor: Beacon Therapeutics ### Study Description This Phase 2 study is a non-randomized, open-label, study of the safety of AGTC-501 in participants with XLRP who have previously been treated with a full-length AAV vector-based gene therapy targeting RPGR protein. ### Conditions - X-Linked Retinitis Pigmentosa ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - AGTC-501 (high dose and standard corticosteroid regimen) - AGTC-501 (low dose and standard corticosteroid regimen) - AGTC-501 (high dose and modified corticosteroid regimen) ### Outcomes Primary Outcomes - The primary safety outcome is the number and proportion of participants experiencing Grade 3 or higher local (ocular) or non-ocular treatment-emergent adverse events, including treatment-emergent serious adverse events (SAEs). Secondary Outcomes - Change from baseline in mean sensitivity across the whole grid, as measured by MAIA microperimetry - Response, as measured by MAIA microperimetry, where response is defined as a greater than or equal to 7 dB visual sensitivity improvement from baseline in at least 7 loci. - Change from baseline in BCVA using Early-Treatment Diabetic Retinopathy Study (ETDRS) visual acuity - Change from baseline in LLVA using ETDRS visual acuity - Change from baseline in Ora-VNC mobility test score ### Location - Facility: University of Florida, Jacksonville, Florida, 32209, United States @@
## Maladaptive Anger Treatment - NCT ID: NCT06275607 - Study ID: FY23-24-93 - Status: RECRUITING - Start Date: 2024-02-07 - Completion Date: 2025-12-31 - Lead Sponsor: The University of Texas at San Antonio ### Study Description From a psychoevolutionary perspective, anger is a universal emotion that can serve the function of making us aware of wrongdoing and motivating us to undo/correct the wrongdoing. However, it is well recognized in clinical psychology that anger can be maladaptive, often causing distress and impairment in various areas of day-to-day life; untreated maladaptive anger has been found to raise the risk of certain physical health problems e.g., hypertension and coronary heart disease. At the very extreme, rage has been implicated in aggression and violence. Not surprisingly, there has been a widespread quest for anger treatments or what is popularly called "anger management". One treatment approach that has received increasing empirical support is Cognitive Behavioral Affective Therapy (CBAT), which has been applied to patients with chemical dependence and individuals with chronic pain. To extend this programmatic line of research, the proposed research aims to evaluate the efficacy of CBAT in reducing multiple (psychometric and self-monitored) measures of anger within a community sample. ### Conditions - Anger - Intermittent Explosive Disorder - Emotional Distress - Aggression - Violence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cognitive Behavioral Affective Therapy - Emotional Discussion ### Outcomes Primary Outcomes - Anger Parameters Scale (APS) - Anger Parameters Scale (APS) - Anger Parameters Scale (APS) - Anger Expressions Scale (AES) - Anger Expressions Scale (AES) - Anger Expressions Scale (AES) - Self-Monitored Anger (Anger Log) - Self-Monitored Anger (Anger Log) Secondary Outcomes ### Location - Facility: The University of Texas at San Antonio, San Antonio, Texas, 78249, United States @@
## Trial Evaluating the Efficacy of Remimazolam in Endobronchial Ultrasound Guided Transbronchial Needle Aspiration - NCT ID: NCT06275594 - Study ID: YUMC2023-12-017 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-02-01 - Lead Sponsor: Yeungnam University Hospital ### Study Description Study to evaluate the efficacy and safety of remimazolam in patients undergoing endobronchial ultrasound-guided transbronchial needle aspirationPrimary Outcome Evaluate and compare the success of the procedure in patients undergoing EBUS-TBNA (Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration) when administered with remimazolam in the experimental group, versus Real world midazolam (Control Group 1), and On label midazolam (Control Group 2).Secondary Outcome In patients undergoing EBUS-TBNA, compare the following aspects when administered with remimazolam in the experimental group versus Real world midazolam (Control Group 1) and On label midazolam (Control Group 2): Procedure start time, Time taken to achieve full alertness, Need for flumazenil administration, Total dose of fentanyl used, Scale of coughing/discomfort/convenience, Changes in vital signs, Complications related to the procedure. ### Conditions - Midazolam - Remimazolam ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Byfavo - Midazolam ### Outcomes Primary Outcomes - Procedural success during EBUS-TBNA (composite outcome) Secondary Outcomes - Time to start of procedure after administration of the first dose of study medication - Time taken to achieve full alertness after the procedure - Requirement for flumazenil dosage during the procedure - Total fentanyl dose - Scale of coughing/discomfort/inconvenience - Changes in blood pressure - Changes of heart rate - Changes in respiration rate - Complications related to the procedure ### Location - Facility: Yeungnam University Hospital, Daegu, Namgu, 42415, Korea, Republic of @@
## Clinical Evaluation of the Performance of a Newly Developed Glass Ionomer Restorative for Posterior Restorations in an Adult Population - NCT ID: NCT06275581 - Study ID: CR15_15 (EM-11-050055) - Status: TERMINATED - Start Date: 2017-06-14 - Completion Date: 2021-10-01 - Lead Sponsor: Universidad Europea de Madrid ### Study Description STUDY DESIGN Post market clinical follow-up; pilot study, prospective, controlled, randomized, split-mouth, blinded evaluation INTRODUCTION AND PURPOSE OF STUDY Continuous advancements in the field of glass ionomers have led to an increasing range of permanent indications, especially with regards to stress bearing Class II restorations. As a further development in the 3M glass ionomer category, Ketac Universal can be used for the abovementioned indication in a simplified procedure without the need for cavity conditioning or restoration coating. All products used in this study are CE marked thus can be used for routine clinical treatment.STUDY OBJECTIVES Objective of the study is to evaluate the clinical survival and quality parameters of Class II Ketac Universal restorations compared to intra-individual (split-mouth) Class II Ketac Molar Quick control restorations over time STUDY ENDPOINTSPrimary Endpoint:1. Evaluation of restoration survival over time based on the glass ionomer restoration criteria (simplified FDI criteria as proposed by Mathilde Peters et al.)Secondary Endpoints:1. Evaluation of restoration quality based on the glass ionomer restoration criteria (simplified FDI criteria)2. Evaluation of restoration wear based on comparison of digital impressionsSafety Endpoint:1. Evaluation of potential adverse events NULL HYPOTHESIS There is no statistically significant difference between both glass ionomers* regarding overall survival* regarding restoration quality parameters TEST GROUP Ketac Universal Aplicap Glass Ionomer Restorative (3M) CONTROL GROUP Ketac Molar Quick Aplicap Glass Ionomer Restorative (3M)* regarding restoration wear METHODS AND MATERIALS A total of 39 subjects were enrolled and treated. The study was originally planned with 80 patients. Due to slow recruitment, it was decided to decrease the number of patients.Treatment:After signing informed consent, test and control product were randomly assigned to the two study teeth (randomization letter). Restoration extension (e.g. mod) and reason for restoration placement (e.g. secondary caries, tooth fracture) were recorded in the CRF. Two teeth per subject were included. Each product was used strictly according to respective Instructions for Use without using the optional protective coating. Restorations were placed in combination with sectional matrix system (Palodent system) and according to best practice (especially with regards to moisture control). Finishing and polishing was done with the Sof-Lex system. Areas in close proximity to the pulp were covered with local application of a calcium hydroxide material in both study materials. Study teeth were excluded from study if pulp exposure had occurred or if only a repair restoration was required instead of a full Class II restoration.Evaluation periods:All subjects were evaluated by two independent evaluators according to Performance Criteria for Posterior Glass Ionomer Restorations (simplified FDI criteria)* at baseline at day of restoration placement or up to 1 month after restoration placement* after 6 months (± 1 months)* after 1 year (± 1 months)* after 2 years (± 1 months) In addition, photos (at least occlusal view) were taken of every study tooth prior to restoration placement and at every evaluation.In order to further assess the wear of both restorative materials, full arch digital impressions (both upper and lower jaw) were taken at baseline evaluation and at every following evaluation using 3M True Definition Scanner. STL files were digitally compared to those taken at baseline. ### Conditions - Tooth Wear - Glass Ionomer Cements ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ketac Universal Aplicap Glass Ionomer Restorative (3M) (test group) - Ketac Molar Quick Aplicap Glass Ionomer Restorative (control group) ### Outcomes Primary Outcomes - Restoration survival over time based on the glass ionomer restoration criteria Secondary Outcomes - Evaluation of restoration quality based on the glass ionomer restoration criteria - Evaluation of restoration wear based on comparison of digital impressions - Safety Endpoint: The safety endpoint is the incidence of Adverse Events. ### Location - Facility: Dental Health Clinic at Universidad Europea de Madrid (UEM) Department of Prosthodontics, Madrid, N/A, 28045, Spain @@
## Accelerating Healthcare Engagement in Healthy Food Interventions - Food Rx in High Risk Pregnant Mothers With About Fresh and Texas Children's Health Plan - NCT ID: NCT06275568 - Study ID: HSC-SPH-23-0655 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-11-15 - Lead Sponsor: The University of Texas Health Science Center, Houston ### Study Description The purpose of the study is to assess if the Fresh Connect food prescription (Fresh Connect Food Rx) program that provides consistent access to healthy fresh produce through purchases at the grocery store plus nutrition education impacts gestational weight gain, other pregnancy and birth outcomes, and food and nutrition security in low-income, ethnically diverse, at-risk women residing in Houston, Texas. Enrollment of participants will begin in pregnancy at the time of the first prenatal visit (as long as the first visit occurs before the end of the first trimester); each participant will be followed until 60 days post-partum (up to 11 months follow-up per participant). ### Conditions - Nutrition in High-Risk Pregnancy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Usual Care Fresh Connect cardholder engagement - Enhanced engagement communication ### Outcomes Primary Outcomes - Absolute gestational weight gain (GWG) in pounds - Absolute gestational weight gain (GWG) in pounds - Absolute gestational weight gain (GWG) in pounds - Excess gestational weight gain (EGWG) in pounds - Excess gestational weight gain (EGWG) in pounds - Excess gestational weight gain (EGWG) in pounds Secondary Outcomes - Number of participants diagnosed with pregnancy-induced hypertension - Number of participants diagnosed with gestational diabetes - Number of participants with pre-term birth (<37 weeks) - Infant birth weight ### Location - Facility: The University of Texas Health Science Center at Houston, Houston, Texas, 77030, United States @@
## Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation - NCT ID: NCT06275555 - Study ID: 2023-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-12-31 - Lead Sponsor: Xiaotong Hou ### Study Description The purpose of this study was to evaluate the efficacy and safety of bivalirudin in anticoagulation therapy in patients with extracorporeal membrane oxygenation (ECMO) compared with unfractionated heparin. ### Conditions - Extracorporeal Membrane Oxygenation Complication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - bivalirudin - unfractionated heparin ### Outcomes Primary Outcomes - thrombotic complications - bleeding complications Secondary Outcomes - Hospitalization mortality - Loop replacement - Infusion volume of blood products - Acute renal failure - Heparin-induced thrombocytopenia - the time of reaching the target anticoagulant level for the first time - Percentage of time during ECMO within the target anticoagulant level ### Location - Facility: Beijing Anzhen Hospital, Beijing, Beijing, 100029, China @@
## Ability to Maintain Saturation Levels Without Oxygen Supplementation as a Extubation Criteria Without TOF Monitoring Equipment - NCT ID: NCT06275542 - Study ID: USurabaya - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-01-01 - Lead Sponsor: University of Surabaya ### Study Description Patients undergoing general anesthesia will have an endotracheal tube inserted. Adequate muscle strength recovery in the recovery room is crucial to ensure before extubation. One of the criteria we use to determine the recovery of muscle strength post-use of muscle relaxants in conditions without specific monitoring devices is the ability to maintain body oxygen levels without oxygen assistance for 3 minutes. This study aims to determine the muscle strength value in the recovery room using extubation strategies without muscle strength monitoring compared to extubation strategies with muscle strength monitoring. ### Conditions - Anesthesia Intubation Complication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Train of four monitoring device intraoperative - Neostigmine - Air chalenge prior to extubation - Train of Four monitoring device in recovery room ### Outcomes Primary Outcomes - Residual paralysis in recovery room Secondary Outcomes - Adverse events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of Transforaminal Epidural Steroid Injection in Radicular Low Back Pain According to MSU Classification - NCT ID: NCT06275529 - Study ID: 27.12.2023.685 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-08-15 - Lead Sponsor: Başakşehir Çam & Sakura City Hospital ### Study Description Low back pain is a common disease in all ages and it effects seriously quality of life. Medical treatment,interventional methods and surgery are the treatment options. Transforaminal epidural steroid injections (TFSI) is one of the interventional method for radiculopathy with low back pain. Michigan State University(MSU) classification is a MRI based disc herniation classification. It helps to classified disc herniation in types, places and sizes.The aim of this study to evaluate the pain and oswestry disability index in patients who have radiculopathy with low back pain, undergone TFSI according to MSU classification. ### Conditions - Radiculopathy Lumbar - Low Back Pain - Disc Herniation - Injections, Epidural ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Transforaminal Epidural Steroid Injection ### Outcomes Primary Outcomes - Change of the pain severity score - Change of the disability score Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Safety and Efficacy of Multisensory Stimulation Virtual Reality for Stroke Patients. - NCT ID: NCT06275516 - Study ID: 2024-208 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-20 - Completion Date: 2024-09-20 - Lead Sponsor: First Affiliated Hospital of Chongqing Medical University ### Study Description This was a single-blind randomized controlled trial of multisensory stimulation virtual reality to improve motor and cognitive dysfunction in stroke patients. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - multi-sensory stimulation immersive VR+ treadmill training - treadmill training ### Outcomes Primary Outcomes - Fugl-Meyer scale - Berg balance scale - three-dimensional gait detection - Fall incidents - Dizzy incidents Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## STROKESTOP III - Optimized Method for Atrial Fibrillation Screening - NCT ID: NCT06275503 - Study ID: STROKESTOP III - Status: NOT_YET_RECRUITING - Start Date: 2024-02-20 - Completion Date: 2026-06-30 - Lead Sponsor: Danderyd Hospital ### Study Description Atrial fibrillation is the most common sustained cardiac arrhythmia affecting more than 3% of the adult population. The symptoms of atrial fibrillation can range from asymptomatic to debilitating. It can be permanent in its nature, but also paroxysmal with only short bursts of atrial fibrillation randomly occurring and can therefore remain unnoticed. Atrial fibrillation increases the risk of stroke five fold if left untreated.Screening for atrial fibrillation in elderly populations above age 65 years can result in detection of new atrial fibrillation cases ranging from 0,5% new AF with a single time-point ECG, up to 30% AF if an implantable loop recorder is inserted for 3 years.Currently opportunistic screening using pulse palpation, or a single time-point ECG is recommended by the European Society of Cardiology guidelines. Systematic screening in individuals aged 75 or above, or at a high stroke risk should be considered.Overall, participation in systematic atrial fibrillation screening trials has been shown to be relatively low with almost 50% non-participants. Participants are generally healthier, with higher socioeconomic status, hence the ones who would potentially benefit the most remain absent.Opportunistic screening has shown promising results with higher participation rates and the possibility of better outreach. There is a lack of data from randomized trials on the difference in participation rates in systematic and opportunistic screening approaches when screening with prolonged ECG monitoring. ### Conditions - Atrial Fibrillation - Atrial Fibrillation New Onset ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Screening invitation mode ### Outcomes Primary Outcomes - Participation in screening Secondary Outcomes - AF detection in opportunistic compared to systematic screening - OAC treatment after AF detection - Compliance to OAC treatment 1 year after initiation - Health economy - Composite endpoint of stroke, death and severe bleeding - Reminder strategy effect on participation - Comparison of automatic ECG analysis (using AI) for detection of AF in a (by AI algorithm classified) high- compared to a low-risk group - Application of the FIND-AF algorithm ### Location - Facility: Karolinska Institutet, Dept Med H, Stockholm, N/A, 141 86, Sweden @@
## Post Extraction Changes Following Ridge Preservation Using Partially Demineralized Dentin Block Versus L- PRF Block - NCT ID: NCT06275490 - Study ID: 181123PER6_3_1 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-11-15 - Lead Sponsor: Cairo University ### Study Description * The aim is to evaluate post extraction hard tissue changes following ridge preservation using partially demineralized dentin block versus L-PRF block in intact socket in the esthetic zone.* The main question: In patients with un restorable tooth, Will ridge preservation using partially demineralized dentin block be more effective than L-PRF block in managing the post extraction hard tissue alterations?* After enrolment, periodontal and radiographic examination and patients with badly un-restorative tooth in the esthetic zone will be identified. These patients will undergo to mesio-distal distance between adjacent teeth, corono-apical height of bone, presence of labial undercut, dehiscence, or fenestration and Relation to adjacent teeth measurements using trans gingival probing technique, and preapical radiograph or CBCT .* In both groups, the desired tooth will be extracted under local anesthesia using peritomies and surgical forceps.* In intervention group: the teeth will be cleaned and dried, and then the dentin will be ground to obtain particles of a certain size then partially demineralize dentin will obtained by using a tooth transformer machine. At the same time, blood samples are collected and processed to obtain fibrin membranes rich in platelets and leukocytes. This tissue is then mixed with partially demineralized dentin to create a solid mass called a "dentin block". During the process of preserving the alveolar bumps after extraction, this solid mass "dentin mass" is placed inside the dental pockets and covered with fibrin membranes rich in platelets and white blood cells, then 5/0 proline suture are used to fix the fibrin membranes and dentin mass in place. After the recovery period "4-6 months", a biopsy is taken for some cases from the site of the operation for histological evaluation during implant placement.* In control group: the same steps as the first group will be used, but by replacing the partially demineralized dental graft with a xenograft.* Outcomes: Radiographic vertical buccal bone changes, vertical Palatal bone changes, horizontal bone changes, Percentage of new vital bone formation, Percentage of residual bone graft, Implant Primary Stability. The results directly postoperative and 4-6 months postoperatively. ### Conditions - Socket Preservation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Partially Demineralized Dentin Block - L-PRF block ### Outcomes Primary Outcomes - Radiographic vertical bone changes Secondary Outcomes - Radiographic horizontal bone changes - Percentage of new vital bone formation and residual graft - Implant Primary Stability ### Location - Facility: Faculty of dentistry Cairo University, Cairo, Elmanil, 4240101, Egypt @@
## 68Gallium-FAPI PET/CT Imaging in Chronic Inflammatory and Fibrotic Diseases - NCT ID: NCT06275477 - Study ID: 29BRC23.0029 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-04-21 - Lead Sponsor: University Hospital, Brest ### Study Description This single-center pilot study is designed to explore the preliminary utility of the \[68Ga\] Ga-FAPI imaging agent in positron emission tomography (PET) combined with computed tomography (CT) for a range of chronic inflammatory and fibrosing diseases. The study focuses on the potential of \[68Ga\] Ga-FAPI, a novel radiotracer targeting Fibroblast Activation Protein (FAP), to improve diagnostic accuracy in various medical conditions. Thirteen distinct clinical situations have been selected for this investigation, including rheumatoid arthritis, liver fibrosis, and systemic lupus, among others. This approach aims to ascertain the value of further clinical development in each area and refine the use of this imaging modality in routine care for both initial evaluation and ongoing monitoring of these diseases. ### Conditions - Inflammatory Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - 68Ga-FAPI46 ### Outcomes Primary Outcomes - PET uptake intensity Secondary Outcomes - [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation - [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation - [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation - [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation - [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation - [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation - [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation - [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation - [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation - [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation - [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation - [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation - [68Ga]Ga-FAPI PET/CT - Biomarkers correlation - [68Ga]Ga-FAPI PET/CT - Biomarkers correlation - [68Ga]Ga-FAPI PET/CT - Biomarkers correlation - [68Ga]Ga-FAPI PET/CT - Biomarkers correlation - [68Ga]Ga-FAPI PET/CT - Biomarkers correlation - [68Ga]Ga-FAPI PET/CT - Biomarkers correlation - [68Ga]Ga-FAPI PET/CT - Functional parameters correlation - [68Ga]Ga-FAPI PET/CT - Functional parameters correlation - [68Ga]Ga-FAPI PET/CT - Functional parameters correlation - [68Ga]Ga-FAPI PET/CT - Functional parameters correlation - [68Ga]Ga-FAPI PET/CT - Functional parameters correlation - [68Ga]Ga-FAPI PET/CT - Functional parameters correlation - [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation - [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation - [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation - [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation - [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation - [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation - [68Ga] Ga-FAPI PET/CT parameters evolution - [68Ga] Ga-FAPI PET/CT parameters evolution - [68Ga] Ga-FAPI PET/CT / [18F] F-FDG PET/CT comparison - [68Ga] Ga-FAPI PET/CT kinetic - [68Ga] Ga-FAPI PET/CT kinetic - [68Ga] Ga-FAPI PET/CT kinetic ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## BT-600 Single and Multiple Ascending Oral Doses in Healthy Adult Subjects - NCT ID: NCT06275464 - Study ID: BT-600-101 - Status: RECRUITING - Start Date: 2024-01-11 - Completion Date: 2024-06 - Lead Sponsor: Biora Therapeutics, Inc. ### Study Description This is a randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BT-600 when administered in single and multiple ascending doses to healthy participants. The study will enroll up to 48 participants, with participation lasting 2-3 weeks in addition to up to 28 days (about 4 weeks) for screening.The purposes of this study are to learn about the safety and tolerability of single and multiple rising oral doses of BT-600, assess the blood and tissue levels of tofacitinib released from BT-600, and assess the body's effects to the study drug following oral doses of BT-600 in blood and tissue in healthy adult participants.BT-600 is a swallowable drug/device combination product designed to deliver a liquid formulation of tofacitinib to the colon and dispense the study drug throughout the colon. BT-600 consists of two components, the drug part containing a reservoir, which will be filled with liquid tofacitinib, and the drive part. The drive part contains the hardware and software that identifies the colon region and then dispenses the drug to the specific region. The device which contains the drug is referred to as the NaviCap™ device. The NaviCap device is approximately the size of a fish oil pill, is made of plastic material known to be safe for ingestion and has rounded ends for ease of swallowing. Liquid tofacitinib in the reservoir is automatically released when the BT-600 localization technology determines that it has reached the colon. BT-600 passes through the colon and the NaviCap device is excreted via a bowel movement. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - BT-600 - BT-600 Placebo ### Outcomes Primary Outcomes - Adverse Events Secondary Outcomes - Pharmacokinetic (PK) Assessments ### Location - Facility: Celerion, Lincoln, Nebraska, 68502, United States @@
## Qualitative Study of Emotional Regulation in Schizophrenia - NCT ID: NCT06275451 - Study ID: EssaiClinique_QUALI-RES - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2026-01 - Lead Sponsor: University Hospital, Grenoble ### Study Description The main aim of this study is to investigate emotional regulation in individuals with schizophrenia using a qualitative methodology (semi-structured interview) and, therefore, from the person's point of view.Given the qualitative nature of the methodology used in this study, the investigators have no specific hypothesis. The investigators have a general hypothesis suggesting that the patients' discourse will enable us to highlight the emotional regulation difficulties described in the literature. ### Conditions - Schizophrenia - Schizophrenia Schizoaffective ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Semi-structured interview ### Outcomes Primary Outcomes - Emotional regulation in schizophrenia Secondary Outcomes - Factors influencing emotional regulation in schizophrenia - Improved emotional regulation in schizophrenia - Stages of emotional regulation in schizophrenia ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of Oxytocin Receptor Immunoreactivity in Placentas Obtained From Women Having Cesarean and Natural Birth - NCT ID: NCT06275438 - Study ID: 81829502.903/39 - Status: COMPLETED - Start Date: 2018-08-25 - Completion Date: 2019-12-01 - Lead Sponsor: Kafkas University ### Study Description Our study examines the effects of oxytocin hormone receptors. mechanisms of placental tissue cells and therefore intrauterine development. It was conducted to investigate the effects on newborn babies apgar score, fontanel openings, birth weights, etc. By collecting data, normal and They were compared between cesarean births by statistical analysis. normal in this regard Based on the hypothesis that there is a difference between labor and cesarean delivery, this study has been made.OXTR primary antibody was used for immunohistochemical examination. There was no significant difference between the groups in terms of histological examination. In the study, it was found that OXTR immunoreactivity was strong in decidual cells and stromal cells in villi. A stronger OXTR immunoreactivity was detected in villous stroma of placenta of the natural birth group compared to the cesarean birth group. Reaction was not observed in syncytotrophoblast cells and syncytial nodes in both groups, but strong immunoreaction was observed fetal endothelial cells and fetal capillaries in both groups. ### Conditions - Healthy Mothers Who Have Had Both Vaginal and Cesarean Deliveries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - The delivery being performed via cesarean section surgery rather than natural childbirth ### Outcomes Primary Outcomes - Oksitosin Receptor Immunoreactivity Secondary Outcomes - Pearson correlation analysis ### Location - Facility: Kafkas Universty, Kars, Merkez, 36100, Turkey @@
## Comparison of the Coughing Frequency of Remimazolam Total Intravenous Anesthesia Versus Inhalational Anesthesia - NCT ID: NCT06275425 - Study ID: 4-2023-0429 - Status: COMPLETED - Start Date: 2023-06-25 - Completion Date: 2023-11-29 - Lead Sponsor: Yonsei University ### Study Description This study is a randomized controlled trial. Adult patients undergoing thyroidectomy under general anesthesia at Severance Hospital and Yonsei Cancer Center are included in tis study. For intervention group, patients receive anesthesia with total intravenous remimazolam, while for control group, patients receive anesthesia with inhalation anesthetic.The primary end point of the study is to determine whether coughing during endotracheal tube extubation is less when anesthesia is maintained with intravenous remimazolam compared to inhalation anesthetics. The secondary end points are cough score (graded into 4 levels), frequency of reoperation due to postoperative bleeding, These include the frequency of hypertension during the extubation process and whether additional painkillers are used in the recovery room. ### Conditions - Thyroid Neoplasm - Cough ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Total intravenous anesthesia with Byfavo - Inhalation anesthesia with Sevoflurane ### Outcomes Primary Outcomes - Proportion of patients not coughing during postoperative extubation Secondary Outcomes - Cough score ### Location - Facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, College of Medicine, Yonsei University,, Seoul, N/A, N/A, Korea, Republic of @@
## Family Intervention for Black Teens With Type 1 Diabetes - NCT ID: NCT06275412 - Study ID: IRB-23-04-5675 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2028-03 - Lead Sponsor: Wayne State University ### Study Description The purpose of this study is to conduct a multicenter, randomized effectiveness trial of The 3Ms 2.0 compared to an educational control condition for improving adolescent glycemic control and diabetes-related family relationships and reducing primary caregiver diabetes-related distress among Black adolescents with type 1 diabetes (T1D) and their primary caregivers. The proposed study would develop and test The 3Ms 2.0 adapted intervention when delivered using a mobile health approach (accessed via parents' cell phone). The intervention will also include new family intervention content (videoclips and text messages). ### Conditions - Type 1 Diabetes - Family Relations ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - The 3Ms 2.0 Intervention - Educational Attention Control (EAC) ### Outcomes Primary Outcomes - Glycemic Control Secondary Outcomes - Caregiver Diabetes Distress - Diabetes-Specific Family Conflict - Diabetes-Specific Parental Monitoring - Diabetes-Specific Family Support ### Location - Facility: Children's National Hospital, Washington, District of Columbia, 20010, United States @@
## Comprehensive Assessment of Morphometric, Functional, Biomechanical and Biological Interactions Between Atherosclerotic Plaque and Platelets Within the Stenosed Coronary Artery - NCT ID: NCT06275399 - Study ID: INTERFORCE - Status: RECRUITING - Start Date: 2023-07-21 - Completion Date: 2026-07-21 - Lead Sponsor: Medical University of Warsaw ### Study Description The main objective of the present study is to verify, in vivo, whether shear forces computed solely based on coronary angiography and computational fluid dynamics (CFD) techniques are associated with the biomarkers indicating the prothrombotic tendency of circulating blood in situ - distally and proximally to the coronary stenosis. The study will prospectively assess the relationship between i) the value and distribution of shear rate and shear stress (SS) estimated using three-dimensional angiography and CFD techniques, and ii) atherosclerotic plaque characteristics as assessed by optical coherence tomography (OCT), iii) functional parameters of diseased vessels assessed by vessel fractional flow reserve (vFFR), and iv) in situ platelet activation, as expressed by platelet-derived microvesicles (pMVs) and small extracellular vesicles (sEVs), platelet aggregometry and other serum prothrombotic or inflammatory biomarkers sampled within the coronary artery. ### Conditions - Chronic Coronary Syndrome - Atherosclerosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - OCT examination - Blood sampling - Assessment of vFFR and shear stress parameters ### Outcomes Primary Outcomes - Correlation between the mean shear rate and shear stress values at the lesion's site and the concentration of pMVs and sEVs sampled in the distal segment of the artery. Secondary Outcomes - Correlation between the shear stress measurements at the site of the lesion and the concentration of inflammatory biomarkers in the distal segment of the artery - Correlation between the shear stress measurements at the site of the lesion and the platelet reactivity parameters in the distal segment of the artery - Correlation between the shear rate and shear stress values at the site of the lesion and the gradient (delta) concentration of the pMVs and sEVs - Correlation between the shear rate and shear stress values at the site of the lesion and the gradient (delta) concentration of inflammatory biomarkers - Correlation between the shear rate and shear stress values at the site of the lesion and the gradient (delta) of platelet reactivity - Concentrations of inflammatory biomarkers categorized by the atherosclerotic plaque morphology and the mean value of shear stress affecting the endothelium at the stenosis site and as well as according to the vessel - Platelet reactivity levels categorized by the atherosclerotic plaque morphology and the mean value of shear stress affecting the endothelium at the stenosis site and as well as according to the vessel - Concentrations of pMVs and sEVs categorized by the atherosclerotic plaque morphology and the mean value of shear stress affecting the endothelium at the stenosis site and as well as according to the vessel - Platelet reactivity levels in blood sampled from the stenosed vs. the non-stenosed coronary artery - Concentrations of analyzed pMVs and sEVs in blood sampled from the stenosed vs. the non-stenosed coronary artery - Concentrations of analyzed inflammatory biomarkers in blood sampled from the stenosed vs. the non-stenosed coronary artery - Correlation between vFFR delta pressure and the delta platelet reactivity in stenosed artery compared to these gradients in a non-stenosed artery in the same patient - Correlation between vFFR delta pressure and the delta concentration of the pMVs and sEVs in stenosed artery compared to these gradients in a non-stenosed artery in the same patient - Correlation between vFFR delta pressure and the delta concentration of the inflammatory biomarkers in stenosed artery compared to these gradients in a non-stenosed artery in the same patient ### Location - Facility: Medical University of Warsaw, Warsaw, Mazowieckie, 02-097, Poland @@
## Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention - NCT ID: NCT06275386 - Study ID: 2.31/II/24 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-09-01 - Lead Sponsor: National Institute of Cardiology, Warsaw, Poland ### Study Description The IMAGINATION trial is an investigator-initiated, prospective, single-center study of symptomatic patients with a native chronic total occlusion (CTO) undergoing intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) with a drug-coated balloon (DCB). Post-PCI IVUS and fractional flow reserve (FFR) at baseline and at 6-months follow-up will be performed. In addition, patients included in the coronary computed tomography angiography (CCTA) substudy will undergo photon-counting CCTA at 12-months follow-up. The aim of this study is to evaluate the efficacy and safety of DCB-only approach in native coronary CTO. ### Conditions - Coronary Artery Disease - Total Occlusion of Coronary Artery ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Paclitaxel Drug-coated balloon ### Outcomes Primary Outcomes - In-segment late lumen loss Secondary Outcomes - Angiographic outcomes assessed directly post-PCI - HQ-IVUS outcomes assessed directly post-PCI - Physiologic outcomes assessed directly post-PCI - Angiographic outcomes at 6-months follow-up - HQ-IVUS outcomes at 6-months follow-up - Physiologic outcomes at 6-months follow-up - Computed tomographic outcomes at 12-months follow-up (CCTA substudy) - Clinical outcomes at 12-months follow-up ### Location - Facility: National Institute of Cardiology, Warsaw, Mazowieckie, 04-628, Poland @@
## The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction - NCT ID: NCT06275373 - Study ID: 20-10974 - Status: RECRUITING - Start Date: 2021-05-12 - Completion Date: 2027-12-12 - Lead Sponsor: Walter Reed National Military Medical Center ### Study Description This protocol studies the clinical outcome of patients with active thyroid disease with visually significant signs and symptoms of proptosis, pain, diplopiam lid/orbital edema, or lid/orbital erythema recommended for treatment with teprotumumab infusion (Tepezza®). Patients recommended for treatment will be evaluated by an oculoplastic surgeon (Dr. Eva Chou) and endocrinologist (Dr. Thanh Hoang). ### Conditions - Thyroid Eye Disease - Graves Ophthalmopathy - Graves Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Teprotumumab Injection [Tepezza] ### Outcomes Primary Outcomes - Ophthalmological Clinical Activity Score (CAS) scoring - Thyroid stimulating immunoglobulin Secondary Outcomes - HLA subtypes ### Location - Facility: Walter Reed National Military Medical Center, Bethesda, Maryland, 20889, United States @@
## Repositioning Immunotherapy in VetArans With Lung Cancer - NCT ID: NCT06275360 - Study ID: SPLP-002-23F - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2030-03-31 - Lead Sponsor: VA Office of Research and Development ### Study Description This study is a multicenter Phase II single arm trial to assess the safety and efficacy of chemotherapy and immunotherapy followed by radiotherapy in patients with unresectable Stage III NSCLC. ### Conditions - Non-Small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Nivolumab ### Outcomes Primary Outcomes - Progression-free survival - Treatment Tolerance Secondary Outcomes - Adverse Events - Best overall response rate (BOR) - Overall survival ### Location - Facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA, West Los Angeles, California, 90073-1003, United States @@
## Very Low Calorie Ketogenic Low-fat Diet (VLCKLFD) - NCT ID: NCT06275347 - Study ID: 19CI 30 087 041 - Status: COMPLETED - Start Date: 2021-01-15 - Completion Date: 2023-05-25 - Lead Sponsor: Universidad Veracruzana ### Study Description This study aimed to assess the efficacy and safety of the Zélé program, a controlled ketogenic diet, for weight loss and maintenance. It involved a randomized clinical trial with participants aged 18-60, BMI between 30-34.9 kg/m², and no severe health issues ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Low-fat normoprotein Controlled Ketogenic Diet. - Hypocaloric Balanced Diet ### Outcomes Primary Outcomes - Evaluate the efficacy of this nutritional intervention - Volume of total body tissue corresponding to muscle - Percentage of body weight made up of adipose tissue - Visceral Fat - Bone mass - Total body water - Waist circumference - Hip circumference - Muscular strenght - Weight - Height - BMI Body index mass Secondary Outcomes - Hemoglobin - Hematocrit - Leukocytes - Fasting Blood Glucose - Glycated hemoglobin (HbA1c) - Insulin - Creatinine - Urea - Uric acid - Sodium - Potassium - Calcium - Phosphorus - Magnesium - Albumin - Direct bilirubin - Indirect bilirubin - Total bilirubin - Alanine aminotransferase - Aspartate Amino Transferase - Total cholesterol - Triglycerides - High Density Lipoproteins - Low Density lipoproteins - Protein C Reactive - Thyroid stimulating hormone - Triiodothyronine - Thyroxine - Cholecalciferol - Gasometric variables, Partial pressure of oxygen (PaO2) - HCO3 (Bicarbonate ion plasma concentration) - Arterial pH - Lactic acid ### Location - Facility: Francisco J Nachón García, Ciudad de Mexico, N/A, N/A, Mexico @@
## Dinutuximab Beta at the HUS and the Toulouse Oncopole - NCT ID: NCT06275334 - Study ID: 9133 - Status: RECRUITING - Start Date: 2023-11-28 - Completion Date: 2024-11-28 - Lead Sponsor: University Hospital, Strasbourg, France ### Study Description In this study the investigators wish to describe the cohort of pediatric patients suffering from neuroblastoma and treated with Dinutuximab and to compare the costs and quality of life between the two French centers, the University Hospital of Strasbourg (HUS) and the Oncopole of Toulouse. ### Conditions - Neuroblastoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Comparison of two methods of treating a pediatric pathology in two French health establishments, the HUS and the Oncopole of Toulouse. Secondary Outcomes ### Location - Facility: Service de Pharmacie - Stérilisation - CHU de Strasbourg - France, Strasbourg, N/A, 67091, France @@
## Physical Exercise Benefits for Cancer Patients - NCT ID: NCT06275321 - Study ID: Elena Garcia Roca - Status: RECRUITING - Start Date: 2021-11-05 - Completion Date: 2025-07-30 - Lead Sponsor: Universitat Jaume I ### Study Description The purpose of the study was to analyze the effect of a synchronous-supervised online home-based group during a 6-month exercise program on physical fitness, body composition and adherence compared to an exercise recommendation group of patients undergoing breast cancer treatment without supervision. ### Conditions - Cancer, Breast - Sports Physical Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Synchronous-supervised online home-based group - Exercise recommendation group ### Outcomes Primary Outcomes - Cardiorrespiratory fitness - Strength - Chair Stand (repetitions) - Flexibility - Incidence of treatments on quality of live assessed by EORTIC QLQ-C30 - Adherence - Rating of perceived exertion - Strength - Hand Grip (Kilograms) - Strength - Squat Jump (height in centimeters) Secondary Outcomes ### Location - Facility: Jaume I University, Castellón De La Plana, Castellón, 12071, Spain @@
## Effect of Raised End-Tidal pCo2 on Choroidal Volume - NCT ID: NCT06275308 - Study ID: STUDY21100163 - Status: RECRUITING - Start Date: 2023-02-27 - Completion Date: 2025-02-27 - Lead Sponsor: University of Pittsburgh ### Study Description This study is to investigate the relationship between arterial carbon dioxide (CO2) concentration and vitreous pressure on the choroidal volume by integrated intraoperative OCT imaging under eye exams under anesthesia. ### Conditions - Intraocular Pressure ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Ventilation manipulation ### Outcomes Primary Outcomes - Intraocular Pressure (IOP) (mmHg) Secondary Outcomes - Choroidal thickness ( microns) ### Location - Facility: University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15224, United States @@
## A Retrospective Study of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis - NCT ID: NCT06275295 - Study ID: ZRJY2021-BJ08-03-01-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-12-31 - Lead Sponsor: China-Japan Friendship Hospital ### Study Description The goal of this observational study is to learn about the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy（TBLC） in progressive pulmonary fibrosis. ### Conditions - Pulmonary Fibrosis - Transbronchial Cryobiopsy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The diagnostic rate of MDD2 based on TBLC Secondary Outcomes - The diagnostic rate of MDD1 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Regenerative Peripheral Nerve Interfaces for the Control of Above-knee Prostheses - NCT ID: NCT06275282 - Study ID: HUM00235849 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-09-30 - Lead Sponsor: University of Michigan ### Study Description Individuals with an above-knee lower limb amputation are known to walk more slowly, expend more energy, have a greater risk of falling, and have reduced quality of life compared to individuals without amputation and those with below knee amputation. One of the driving factors behind these deficits is the lack of active function provided by above-knee prostheses with prosthetic knees and ankles. While many prosthetic devices have been developed for functional restoration after major lower extremity amputation, there remains no stable interface to facilitate reliable, long-term volitional control of an advanced robotic limb capable moving multiple joints. Moreover, there is no existing interface that provides useful sensory feedback that in turn enhances the functional capabilities of the prosthesis. To achieve both greater signal specificity and long-term signal stability, we have developed a biologic interface known as the Regenerative Peripheral Nerve Interface (RPNI). An RPNI consists of a peripheral nerve that is implanted into a free muscle graft that would otherwise go unused in the residual limb. As the nerve grows, it reinnervates the free muscle graft which undergoes a predictable sequence of revascularization and regeneration.The main questions it aims to answer are:1. Can the amplitude, movement specificity and stability of sciatic nerve RPNI electromyography (EMG) signals be detected up to one year post RPNI surgery?2. Do RPNIs contain information to enable control of a physical motorized prosthetic leg with multiple degrees of freedom?3. Does stimulation of sciatic nerve RPNIs provides meaningful sensory feedback?Consenting participants with unilateral transfemoral amputation (TFA) will:1. Undergo RPNI surgery and electrode implantation in the residual limb.2. Attend regular follow-up visits following surgery to assess the health and signal strength of the RPNIs and their ability to use a prescribed prosthesis between 3- and 12-months following implantation.3. Undergo explantation of electrodes following the conclusion of data collection. ### Conditions - Amputation - Prostheses and Implants ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Intramuscular electrodes ### Outcomes Primary Outcomes - Intensity of pain in residual and phantom limbs - Neuropathic Pain in residual limb - Health-Related Quality of Life - Amplitude and signal-to-noise ratio for each RPNI - Classification accuracy for movements of the phantom limb - Threshold for sensation after electrical stimulation of RPNI Secondary Outcomes ### Location - Facility: University of Michigan, Ann Arbor, Michigan, 48109, United States @@
## Endoscopic Mucosal Injection Versus Ultrasound-Guided Injection of Triamcinolone to Treat Subglottic Stenosis - NCT ID: NCT06275269 - Study ID: ZRJY2021-BJ08-04-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-10 - Completion Date: 2024-12-31 - Lead Sponsor: China-Japan Friendship Hospital ### Study Description This study employs a multicenter, randomized controlled trial method, where patients meeting the inclusion criteria for subglottic stenosis are randomly divided into two groups. These groups are respectively undergoing translaryngeal endoscopic mucosal injection and ultrasound-guided injection of triamcinolone treatment. The comparison will focus on various indicators such as therapeutic effect, incidence of adverse reactions, treatment costs, and hospital resource utilization between the two groups. The safety and effectiveness will be compared to determine the relative merits of the two treatment methods. ### Conditions - Subglottic Stenosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ultrasound-Guided - Translaryngeal Endoscopic Mucosal Injection ### Outcomes Primary Outcomes - Incidence of Short-Term Postoperative Complications Secondary Outcomes - Overall medical expenses incurred by patients ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Outcomes of MIST for BPH: A Single-Institution Prospective Study - NCT ID: NCT06275256 - Study ID: HS26226 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-03 - Lead Sponsor: University of Manitoba ### Study Description The investigators wish to perform a prospective study at the Men's Health Clinic in Winnipeg, Manitoba to accomplish two goals: 1) Prospectively describe 1 year outcomes for MIST therapies performed at the clinic 2) perform a head to head comparison of Rezum water vapor therapy vs the iTind device in respect to symptom score improvement, uroflow parameters and side effect profile. ### Conditions - Benign Prostatic Hyperplasia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Rezum - iTind ### Outcomes Primary Outcomes - Symptom Scores - Uroflow - Uroflow - Symptom Scores - Symptom Scores - Symptom Scores Secondary Outcomes - Pain Scale ### Location - Facility: Men's Health Clinic, Winnipeg, Manitoba, R3K 1M3, Canada @@
## Polymorphism of ApoE in Alzheimer's Disease: Genetic Study in Castile and Leon (Spain) - NCT ID: NCT06275243 - Study ID: ETICA-ULE-021-2022 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-07-06 - Completion Date: 2024-03-22 - Lead Sponsor: Universidad de León ### Study Description The general objective of this randomized and longitudinal clinical study was to estimate the frequencies of ApoE variants both in the user population of the "Messengers of Peace" Residences and the "Associations of Relatives of Alzheimer's Patients" in Castile y Leon, since, due to its geographical location at the crossroads, it has received multiple genetic contributions from both northern Europe, the Mediterranean area and northern Africa.The main questions it aims to answer are:* What are the allelic frequencies of ApoE variants in the population of individuals with Alzheimer's disease in Castile and Leon?* Is there a correlation between the ApoE4 variant and the lipid profile in the blood of individuals with Alzheimer's disease in this region? ### Conditions - Alzheimer Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Kit Buccal swab collection & stabilization de Canvax® - Cholesterol levels according to ApoE Genotype - Assessing cardiovascular risk factors in all participants ### Outcomes Primary Outcomes - Distribution of ApoE variants in the Alzheimer's disease population diagnosed in Castile and Leon. Secondary Outcomes - Cardiovascular factors in individuals with Alzheimer's disease and healthy subjects. - ApoE genotypes and cholesterol levels in the Alzheimer's disease population diagnosed in Castile and Leon. ### Location - Facility: University of León, León, N/A, 240071, Spain @@
## Establishment of Human Lung Stem Cell Proliferation System and Organoid Construction in COPD - NCT ID: NCT06275230 - Study ID: ZRJY2021-BJ08-02-07 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2025-12-31 - Lead Sponsor: China-Japan Friendship Hospital ### Study Description The goal of this study is to proliferate human lung stem cell in vitro in order to establish a lung organoid derived from patients with COPD. The main question it aims to answer are:* Can human lung stem cell proliferate in vitro.* Can a lung organoid derived from patients with COPD be established. Participants will be sampled during pulmonary bronchoscope for organoid establishment. ### Conditions - Chronic Obstructive Pulmonary Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Number of Patients completed bronchoscope. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Mindful Yoga for Postpartum Depression - NCT ID: NCT06275217 - Study ID: HMRF17182481 - Status: RECRUITING - Start Date: 2021-01-08 - Completion Date: 2025-12-31 - Lead Sponsor: The Hong Kong Polytechnic University ### Study Description This is a parallel-group randomized controlled trial. A total of 198 postpartum women with depressive symptoms (EPDS scores≥8 at baseline) will be recruited and randomized into two groups: 10-week mindful yoga intervention and 10-week psychoeducation program. Clinical assessment of depression, self-report questionnaires and salivary cortisol tests will be performed at baseline, after 10-week intervention, and at 6-month and 12-month follow-ups. The investigators expected that the mindful yoga intervention will reduce depression after 10 weeks compared to psychoeducation. The mindful yoga intervention will further reduce anxiety, stress, improve quality of life and sleep, and steepen diurnal cortisol slopes. These effects will be maintained for at least six months. ### Conditions - Mood Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Mindfulness-based yoga program - Psychoeducation ### Outcomes Primary Outcomes - Edinburgh Postnatal Depression Scale Secondary Outcomes - Depression Anxiety Stress Scale-Depression - Depression Anxiety Stress Scale-Anxiety - Depression Anxiety Stress Scale-Stress - Pittsburgh Sleep Quality Index - 36 Item-Short Form Health Survey Questionnaire - Five Facet Mindfulness Questionnaire - Pregnancy Symptom Inventory - Cortisol concentration level - Physical fitness - Balance ### Location - Facility: The Hong Kong Polytechnic University, Hong Kong, N/A, N/A, Hong Kong @@
## H. Pylori Screen-and-treat Study in a Population of Young Adults - NCT ID: NCT06275204 - Study ID: 101101252 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2026-12-01 - Lead Sponsor: University of Latvia ### Study Description Gastric cancer remains a major challenge to public health on a global scale. H. pylori related cancer burden contributes to the largest proportion of cancer cases attributable to infections in Europe. Considering its absolute burden and persisting disparities, in addition to the substantial prevalence of H. pylori infection worldwide that is treatable, gastric cancer is a logical target for urgent action for prevention. Population-based H. pylori test-and-treat has therefore been proposed as a strategy for gastric cancer prevention. To fill the gaps in knowledge about gastric cancer prevention through H. pylori screening and eradication in younger adults, a study of a population-based H. pylori test-and-treat strategy in Ireland, Croatia, Latvia, Poland, Romania and Slovenia.Main goals of this study are to assess future program processes, feasibility, acceptability and effectiveness. In total of 6,800 adults aged 30-34 will be tested for H. pylori infection. They will be randomly selected to represent the chosen population and invited to participate in the study based on informed consent. Confirmed infections will be treated by available combined therapy in line with treatment guidelines and the success of eradication will be retested during a control check-up.Patients who will provide their consent to participate will undertake an interview about the risk factors in early childhood and their habits regarding alcohol consumption and use of tobacco. Compliance to testing and treatment, treatment results, adverse effects and reasons for dropping out will be additionally monitored. Gathered data will be analysed in alignment with our research questions. The investigators will disseminate reports and present the results to both the general public and the scientific community in order to foster future developments in gastric cancer prevention. ### Conditions - Gastric Cancer - H Pylori Infection - H Pylori Eradication - H-pylori ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Bismuth-based quadruple therapy - Levofloxacin-based quadruple therapy - Standard triple therapy - Levofloxacin-based triple ### Outcomes Primary Outcomes - Healthcare workers' assessment of feasibility and acceptability of the proposed practical implementation of a screening program Secondary Outcomes - Eradication rate of infection with H. pylori - Description of the adverse events profile - Participation rate of subjects selected for the program ### Location - Facility: University Hospital Centre Zagreb, Zagreb, Grad Zagreb, 10000, Croatia @@
## Alternatives to Dental Opioid Prescribing After Tooth Extraction - NCT ID: NCT06275191 - Study ID: 80758 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-12 - Lead Sponsor: Douglas Oyler ### Study Description The goal of this clinical trial is to test a three-item intervention in oral surgeons who remove teeth. The main questions it aims to answer are:* Can the intervention reduce opioid prescriptions to adolescents and young adults after tooth removal?* Do oral surgeons' beliefs about the intervention and opioid prescribing change?* Do patients that report using opioids after tooth removal have different experiences than patients that do not?Oral surgeon participants will:* Attend a 1-hour education session with a trained pharmacist* Receive patient instructions and blister packs of pain medicine to give to patients* Complete 2 surveys about feasibility and appropriatenessPatient participants will complete a survey about pain and medication use after having a tooth removed.Researchers will compare the intervention to usual care to see if it reduces opioid prescribing. ### Conditions - Analgesics, Opioid - Acute Pain - Tooth Extraction - Adolescent - Acetaminophen - Ibuprofen ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - Multicomponent intervention - Usual care ### Outcomes Primary Outcomes - Odds of post-extraction opioid prescription to adolescent/young adults after tooth extraction Secondary Outcomes - (Change in) intervention feasibility - (Change in) intervention appropriateness - (Change in) opioid prescribing feasibility - (Change in) opioid prescribing appropriateness - Self-reported pain - Self-reported pain interference - Self-reported pain satisfaction ### Location - Facility: University of Kentucky, Lexington, Kentucky, 40536, United States @@
## Medical Thoracoscopy for Diagnosing Unexplained Pleural Effusion: a National Multicenter Retrospective Study - NCT ID: NCT06275178 - Study ID: ZRJY2021-BJ08-02-04 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-12-31 - Lead Sponsor: China-Japan Friendship Hospital ### Study Description This study is a national multicenter retrospective study. Patients with unexplained pleural effusion who underwent thoracoscopic or video-assisted thoracoscopic biopsy for patients in recent 10 years were retrospectively collected from multiple centers to understand the proportion and final etiological composition of pleural effusion in China. ### Conditions - Pleural Effusion - Pleural Effusion, Malignant - Fibrinous Pleuritis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Medical thoracoscopy ### Outcomes Primary Outcomes - The proportion of fibrinous pleurisy in Chinese population Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effects of Acupressure on Improving Postoperative Gastrointestinal Symptom Distress in Esophageal Cancer Patients - NCT ID: NCT06275165 - Study ID: 202301754B0 - Status: RECRUITING - Start Date: 2024-03-27 - Completion Date: 2025-07-18 - Lead Sponsor: CHEN, CHIA-CHEN ### Study Description This study is a quasi-experimental design clinical trial with the primary objective of comparing the health status of patients with esophageal cancer. Participants were divided into an experimental group and a control group. Patients in the experimental group received routine care and acupressure for 5 consecutive days starting from the day after entering the ward after esophageal cancer surgery, in the control group, participants received routine care, and Participants were assessed on the Gastrointestinal Symptom Distress Scale at the end of the intervention. The aim of this study was to verify the effectiveness of acupressure in improving of gastrointestinal symptoms distress after esophageal cancer surgery. ### Conditions - Esophageal Cancer - Gastrointestinal Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - acupressure ### Outcomes Primary Outcomes - Change from Baseline in gastrointestinal symptom distress Scale at study day 5(end day) Secondary Outcomes ### Location - Facility: Chang Gung Memotial Hospital, Taoyuan, N/A, N/A, Taiwan @@
## The Protective Effect of Remote Ischemic Conditioning on Residual Renal Function in Hemodialysis Patients (RIC-HD) - NCT ID: NCT06275152 - Study ID: HDRIC-01 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-20 - Completion Date: 2026-01-19 - Lead Sponsor: Yuanjun Yang ### Study Description Hemodialysis (HD) is the main renal replacement therapy for patients with end-stage renal disease. However, factors such as hemodynamic instability can lead to gradual loss of residual renal function (RRF) in HD patients. The loss of RRF not only affects the adequacy of dialysis and complications control but also impacts the patients' quality of life and survival. Unfortunately, there are currently no effective methods to protect RRF. The purpose of this study is to validate the protective effect of remote ischemic conditioning (RIC) on RRF in HD patients. This will provide evidence for the application of RIC in protecting RRF in HD patients. ### Conditions - End-stage Renal Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Remote ischemic conditioning - Sham Remote Ischemic Conditioning ### Outcomes Primary Outcomes - time to anuria - residual renal function (RRF) - Change in the renal cerebral oxygen saturation Secondary Outcomes - serum creatinine - serum urea nitrogen - C-reactive protein (CRP) - Interleukin-6 - TFF3 - KIM-1 - IP-10 ### Location - Facility: Chinese PLA General Hospital, Beijing, Beijing, 100853, China @@
## Integrated Assessment of Cervicocerebral Vessels to Improve the Brain Injury for CAGB Patients (IACV Study) - NCT ID: NCT06275139 - Study ID: 2023-GSP-GG-9 - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2024-12-31 - Lead Sponsor: China National Center for Cardiovascular Diseases ### Study Description The goal of this study is to establish a prospective study to focus on the high-risk stroke population who require coronary artery bypass graft surgery. It will divide the eligible patients into 1:1 group by simple randomization method. The control group adopt the traditional diagnosis and treatment mode, and only head CT plain scan and carotid artery ultrasound shall be performed. If necessary, relevant disciplines would be consulted but no integrated assessment of cervicocerebral vessels be arranged. The final treatment plan would be decided by the surgeon alone. The experimental group adopt the multidisciplinary collaboration and integrated evaluation mode. In addition to routine diagnosis and treatment as above-mentioned, integrated assessment of cervicocerebral vessels shall be performed, including transcranial color-coded doppler, cerebral perfusion with multislice CT, and cognitive function assessment. Based on the above results, surgical plans will be formulated jointly by multiple disciplines including neurologists, vascular surgeons, ICU physicians and cardiac surgeons. Researchers will compare the two groups to investigate whether integrated assessment of cervicocerebral vessels can reduce the incidence of brain injury compared with conventional diagnosis and treatment mode. ### Conditions - Coronary Disease - Coronary Artery Bypass - Strokes Thrombotic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Integrated Assessment of Cervicocerebral Vessels ### Outcomes Primary Outcomes - The incidence of neurological complications Secondary Outcomes - The incidence of major adverse cardiac events - Neurological scale scores ### Location - Facility: Fuwai Hospital; National Cardiovascular Center; Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, Beijing, 100037, China @@
## Optimizing Surgical Decisions in Young Adults With Breast Cancer - NCT ID: NCT06275126 - Study ID: 23-08026433 - Status: RECRUITING - Start Date: 2024-03-13 - Completion Date: 2027-05 - Lead Sponsor: Weill Medical College of Cornell University ### Study Description The goal of this study is to understand and improve the breast surgical decision-making process for young women newly diagnosed with breast cancer. As part of this study, the investigators will evaluate the impact and use a web-based tool called CONSYDER that is designed to provide useful information to young breast cancer patients. It is also meant to improve communication between young women and their surgeons with the purpose of helping patients make appropriate surgical decisions.Participants will complete surveys within 1 week of the surgical consult and 6 months after surgery. Patients who receive neoadjuvant chemotherapy will also be surveyed after the completion of neoadjuvant treatment but prior to surgery. Some patients will be invited for an interview after their surgery as part of the evaluation. A subset of patients/surgeons will also have their surgical consultation audio-recorded. ### Conditions - Breast Cancer Stage 0 - Breast Cancer Stage I - Breast Cancer Stage II - Breast Cancer Stage III ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - CONSYDER decision aid ### Outcomes Primary Outcomes - Pre-surgical decisional conflict as measured by the Decisional Conflict Scale (DCS) - Use of CONSYDER pre-consult Secondary Outcomes - Knowledge as measured by adapted Breast Cancer Surgery Decision Quality Instrument (BCS -DQI) - Treatment goals and preferences as measured by adapted Breast Cancer Surgery Decision Quality Instrument (BCS-DQI) - Anxiety, as measured with the 8-item Patient Reported Outcomes Measurement Information System (PROMIS) - Anxiety - Short Form - Self-efficacy in communication as measured by the Perceived Efficacy in Patient-Physician Interactions scale (PEPPI). - Decisional regret as measured by the Decision Regret Scale (DRS) - Receipt of contralateral prophylactic mastectomy - Fidelity of implementation of CONSYDER via patient portal email - Use of CONSYDER post-consult - Frequency of CONSYDER use pre-consult - Frequency of CONSYDER use post-consult ### Location - Facility: Yale Cancer Center, New Haven, Connecticut, 06510, United States @@
## BRING-UP Prevention - NCT ID: NCT06275113 - Study ID: K25 - Status: RECRUITING - Start Date: 2023-09-15 - Completion Date: 2026-06-30 - Lead Sponsor: Heart Care Foundation ### Study Description The aim of this observational study is to assess in patients with a documented athero-thrombotic event: coronary artery disease (CAD), cerebrovascular disease (CVD), peripheral artery disease (PAD):* the level of adherence to guideline recommendations with the assumption to improve the rate of patients at goal for cholesterol levels.* the level of adherence to guideline recommendations and the rate of patients at goal for the other relevant and modifiable risk factors for cardiovascular event recurrence. ### Conditions - Ischemic Heart Disease - Cerebrovascular Disorders - Peripheral Arterial Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Adherence to guideline for cholesterol level Secondary Outcomes - Adherence to guideline for other risk factors ### Location - Facility: Ospedale Barone Lombardo - Cardiologia E Utic, Canicatti', AG, 92024, Italy @@
## PREhabilitation in Patients Awaiting Acute Inpatient Cardiac SurgEry - NCT ID: NCT06275100 - Study ID: HUTH - Status: RECRUITING - Start Date: 2024-04-03 - Completion Date: 2025-06 - Lead Sponsor: University of Hull ### Study Description This is a single centre, single arm pilot feasibility study to determine the feasibility and practicality of prehabilitation in acute inpatients waiting for cardiac surgery. We will be looking into participant eligibility, acceptability, recruitment rates, completion rates and barriers to implementing a prehabilitation programme. Secondary outcomes include safety (incidence of adverse events directly related to the study), improvement in 6 minutes walk test (6MWT), hand grip strength, quality of life, and spirometry. At the end of the trial, we will be seeking the feedback of the participants to help us improve the design further. ### Conditions - Cardiac Disease - Aortic Valve Disease - Coronary Artery Disease - Endocarditis - Valve Heart Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Prehabilitation ### Outcomes Primary Outcomes - Feasibility of prehabilitation in acute inpatients waiting for cardiac surgery Secondary Outcomes - Efficacy of prehabilitation - Efficacy of prehabilitation - Efficacy of prehabilitation - Efficacy of prehabilitation - Efficacy of prehabilitation - Complication rate - Safety of Prehabilitation in acute inpatients waiting for surgery ### Location - Facility: Hull University Teaching Hospital, Hull, N/A, HU1 3DR, United Kingdom @@
## Differences in Speed of Recovery From Anesthesia for Intraoral Surgery - NCT ID: NCT06275087 - Study ID: situm1phd - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2026-07 - Lead Sponsor: Clinical Hospital Centre Zagreb ### Study Description The goal of this clinical trial is to compare two groups of patients going in general anesthesia for intraoral surgery, the first group TIVA with propofol and the second group inhalational with sevoflurane. The main questions it aims to answer are to asses speed and quality of recovery from general anesthesia.Participants will fill out a questionnaire to evaluate the quality of recovery from anesthesia using the QoR-40 1h, 24h, and 30 days after waking up from anesthesia in comparison to the results of the same questionnaire before surgery. Also, the investigators will perform a hand grip and bite strength test on the patients after waking up from anesthesia in the operating room, after 1 hour in the recovery room, and after 24 hours compared to preoperative values.The investigators will compare TIVA and Volatile groups to see if there are any differences in recovery seed, muscle strength recovery, postoperative nausea and vomiting, and shivering between groups. ### Conditions - Intraoral Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Propofol - Sevoflurane ### Outcomes Primary Outcomes - "Quality of recovery from anesthesia" QoR-40 questionnaire Secondary Outcomes - bite strength and hand grip strength - Postoperative nausea and vomiting - Postoperative shivering ### Location - Facility: University Hospital Centre Zagreb, Zagreb, N/A, 10000, Croatia @@
## Dry Needling and Therapeutic Exercise on Sleep in Individuals With Chronic Neck Pain and Sleep Disturbance - NCT ID: NCT06275074 - Study ID: 23-007716 - Status: RECRUITING - Start Date: 2024-03-14 - Completion Date: 2025-03-01 - Lead Sponsor: Mayo Clinic ### Study Description Feasibility study investigating the effects of dry needling on individuals with chronic neck pain and sleep disturbance. ### Conditions - Neck Pain - Sleep Disturbance ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Dry Needling - Therapeutic Exercise ### Outcomes Primary Outcomes - Participant retention rate - Participant intervention adherence - Number of adverse responses to treatment Secondary Outcomes - Sleep Duration - Sleep Quality ### Location - Facility: Mayo Clinic - Motion Analysis Lab, Rochester, Minnesota, 55905, United States @@
## Chinese Obesity and MEtabolic Surgery Database (COMES Database) - NCT ID: NCT06275061 - Study ID: KY-2020-021 - Status: RECRUITING - Start Date: 2020-05-01 - Completion Date: 2040-12-31 - Lead Sponsor: Jinan University Guangzhou ### Study Description The purpose of the Chinese Obesity and MEtabolic Surgery Database (COMES Database) is to collect data and examine the long-term effects of metabolic and bariatric surgery on obesity and metabolic disorders in the Chinese population. ### Conditions - Obesity - Metabolic Surgery - Bariatric Surgery - Weight Loss ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Metabolic and Bariatric Surgery ### Outcomes Primary Outcomes - Excess weight loss effect of metabolic and bariatric surgery after 1 year Secondary Outcomes - Excess weight loss effect of metabolic and bariatric surgery in long-term follow-ups - Excess weight loss effect of metabolic and bariatric surgery in long-term follow-ups - Excess weight loss effect of metabolic and bariatric surgery in long-term follow-ups - Glycemic control effect of metabolic and bariatric surgery after 1 year - Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups - Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups - Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups - Glycemic control effect of metabolic and bariatric surgery after 1 year - Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups - Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups - Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups - Glycemic control effect of metabolic and bariatric surgery after 1 year - Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups - Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups - Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups - Glycemic control effect of metabolic and bariatric surgery after 1 year - Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups - Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups - Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups ### Location - Facility: The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong, 510630, China @@
## The Influence of Oral Contraceptives During Disuse - NCT ID: NCT06275048 - Study ID: STUDY00006302 - Status: RECRUITING - Start Date: 2024-01-26 - Completion Date: 2025-05 - Lead Sponsor: University of Central Florida ### Study Description Studies across various sports and physical activities have consistently shown that females incur more injuries compared to their male counterparts, but the underlying reasons for this disparity remain poorly understood. While differences in hormone levels between males and females have been speculated to play a role, very little rigorous research has been conducted to directly examine potential connections between sex hormones and injury risk. Specifically, females have been shown to be at greater risk for hand and wrist injuries. The higher injury incidence begins at puberty and persists across the lifespan, suggesting a link to hormonal factors. However, significant gaps remain in understanding the relationships between the menstrual cycle, exogenous hormones from birth control, and risk factors for sports-related injury in females. The purpose of this study is to examine changes in muscle strength and neuromuscular activation among females using monophasic oral contraceptives, females not using oral contraceptives, and males during one week of wrist/hand immobilization. ### Conditions - Oral Contraceptives - Rehabilitation - Menstrual Cycle - Physical Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Wrist/hand immobilization ### Outcomes Primary Outcomes - Grip Strength Secondary Outcomes - Muscle activation ### Location - Facility: University of Central Florida, Orlando, Florida, 32816, United States @@
## Evaluation of Memantine in the Preservation of Memory and Neurocognition Following CSI - NCT ID: NCT06275035 - Study ID: 4235 - Status: RECRUITING - Start Date: 2024-02-22 - Completion Date: 2031-01 - Lead Sponsor: Tata Memorial Centre ### Study Description The goal of this clinical trial is to evaluate the role of memantine in preservation of memory and neurocognition in patients undergoing craniospinal irradiation. Participants will be randomised into two arms and the interventional arm will receive memantine along with the standard treatment. Researchers will compare the neurocognitive tests of participants in both the arms to see if memantine leads to significant preservation of memory and cognition post radiation therapy. ### Conditions - Neurocognitive Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Memantine Oral Tablet ### Outcomes Primary Outcomes - Cognitive-deterioration-free survival at 2 years Secondary Outcomes - Full-Scale Intelligence Quotient (FSIQ) in children - Overall survival (OS) - Academic performance by scholastic performance and grades - Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of Memantine - Progression-Free Survival (PFS) - Full-Scale Intelligence Quotient (FSIQ) in adults ### Location - Facility: Tata Memorial Hospital, Mumbai, Maharashtra, 400012, India @@
## A Prospective Study on the Treatment of cLM Based on ICG Imaging - NCT ID: NCT06275022 - Study ID: NanjingCH011665 - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2026-06-30 - Lead Sponsor: Nanjing Children's Hospital ### Study Description The goal of this prospective randomized controlled study is to explore the role of indocyanine green-fluorescence imaging in management of cystic lymphatic malformation.. To clarify the application value of indocyanine green-fluorescence imaging in both diagnosis and treatment of cystic lymphatic malformation (cLM) in children, is helpful for exploring pathogenesis of cLM, and providing a clearer scientific basis for subsequent surgical intervention. It also provides alternative for the future diagnosis and treatment of cLM.Participants will receive indocyanine green-fluorescence imaging before operation, while the patients in control group will receive traditional operation.Researchers will compare difference in curative effect between two groups. ### Conditions - Lymphatic Malformation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Inflow occlusion with perforation of septation and sclerotherapy - Perforation of septation and sclerotherapy - Indocyanine green-guided partial resection and sclerotherapy - Partial resection and sclerotherapy ### Outcomes Primary Outcomes - Cure rate - Effective rate - Treatment frequency Secondary Outcomes - Likert score - Wound infection - Delayed healing - Pigmentation ### Location - Facility: Children's hospital of Nanjing medical university, Nanjing, Jiangsu, 210008, China @@
## Chinese Occupational Population Cohort of Lifestyle and Physical Fitness (LiFitChina) - NCT ID: NCT06275009 - Study ID: 2023-1990 - Status: RECRUITING - Start Date: 2023-12-11 - Completion Date: 2026-12-11 - Lead Sponsor: China National Center for Cardiovascular Diseases ### Study Description The incidence and prevalence of metabolic risk factors such as obesity, hypertension, diabetes, and dyslipidemia, as well as cardiovascular diseases (CVD), are continuously rising among the occupational population in China, primarily comprising the middle-aged and young adults. Unhealthy lifestyles and declining physical fitness are independent risk factors affecting cardiovascular health. Additionally, the level of physical fitness is influenced by postnatal lifestyles. Lifestyle factors related to cardiovascular health in the occupational population encompass various aspects, including smoking, physical activity, diet, sleep, psychological stress, etc. These factors may interact or have a synergistic effect, necessitating a comprehensive assessment.This project proposes a prospective cohort study design to establish a monitoring cohort for lifestyle and physical fitness among the occupational population. The study will track and follow individuals with or without any CVD metabolic risk factors, collecting information on general status, lifestyle, physical fitness, and health examination data. Exposure factors such as lifestyle and physical fitness will be measured annually, and the occurrence of CVD-related health outcomes will be observed. The aim is to develop a comprehensive evaluation index for cardiovascular health lifestyle, analyze the direct and indirect impacts of lifestyle and physical fitness on the occurrence and development of CVD, and explore potential mediating and moderating effects of physical fitness in the association between lifestyle and cardiovascular health. ### Conditions - Lifestyle - Physical Fitness - Cardiovascular Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - the composite end point of new major adverse cardiovascular events Secondary Outcomes - new incidence of each major adverse cardiovascular events - new incidence of cancer - new incidence of all-cause death - level of systolic pressure - level of diastolic pressure - level of blood lipid - level of BMI - level of maximal oxygen uptake (VO2max) - level of metabolic equivalents (METs) ### Location - Facility: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing, N/A, China @@
## Efficacy and Safety Analysis of Upadacitinib in Inflammatory Bowel Disease - NCT ID: NCT06274996 - Study ID: 2024ZSLYEC-063 - Status: COMPLETED - Start Date: 2021-01-01 - Completion Date: 2023-12-31 - Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University ### Study Description This study focuses on evaluating Upadacitinib, a new oral medication that inhibits specific enzymes involved in inflammation, for treating inflammatory bowel disease (IBD), which includes conditions such as Crohn\'s Disease and Ulcerative Colitis. The goal is to determine how effective and safe this drug is for patients in China, where data is currently lacking.IBD significantly affects individuals\' quality of life and imposes a high burden on society and healthcare systems. Current treatments don\'t work for everyone, and some patients may need surgery. Upadacitinib has shown promise in other countries for treating IBD and related conditions and has been approved by the US FDA for such use.Our study is retrospective and multicenter, meaning it will look back at patient records from multiple hospitals to analyze the outcomes of those who have received Upadacitinib. Investigators aim to enroll patients treated between January 2020 and December 2023, focusing on adults who have taken Upadacitinib for at least 8 weeks.For patients, families, and healthcare providers, this research could mean a potential new treatment option for IBD. Understanding Upadacitinib\'s efficacy and safety could lead to better management of the disease, possibly reducing the need for surgery and improving the quality of life for those affected by IBD. The ultimate goal is to provide more personalized and effective treatment strategies for IBD patients in China. ### Conditions - Inflammatory Bowel Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Upadacitinib ### Outcomes Primary Outcomes - Steroid-Free Clinical Remission Secondary Outcomes - Clinical Response - Endoscopic Remission - Mucosal Healing - Radiological remission - Radiological response ### Location - Facility: the Sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, 510655, China @@
## DMD- Interactive Virtual Reality Study - NCT ID: NCT06274983 - Study ID: SCH-2629 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-04-20 - Completion Date: 2024-02-29 - Lead Sponsor: Sheffield Children's NHS Foundation Trust ### Study Description This study will help determine if an Interactive Virtual Reality system can improve the physiotherapy of young patients with Duchenne muscular dystrophy (DMD). ### Conditions - Duchenne Muscular Dystrophy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - IVR platform trial ### Outcomes Primary Outcomes - Compliance: Ratings of frequency of the DMD-IVR device use for the participant's to complete recommended physiotherapy exercises. - Compliance: Ratings of duration of the DMD-IVR device use for the participant's to complete recommended physiotherapy exercises. - Post-trial qualitative interviews on perceptions, acceptability, usability and effectiveness of DMD-IVR device in the context of the family's overall burden of care - DMD-IVR Effectiveness standard functional assessments: North Star Ambulatory Assessment (NSAA) - DMD-IVR effectiveness measures with a Timed test 4 stair climb - DMD-IVR effectiveness measured joint range of movement using Goniometer (Standard BASELINE® 12-inch) Secondary Outcomes ### Location - Facility: Sheffield Childrens NHS FT, Sheffield, South Yorkshire, S10 2TH, United Kingdom @@
## PaThERAS: ERAS Protocols in Thyroid & Parathyroid Surgery - NCT ID: NCT06274970 - Study ID: 2022-143-Mch-EXP-50 - Status: RECRUITING - Start Date: 2023-01-25 - Completion Date: 2024-09-25 - Lead Sponsor: Sanjay Gandhi Postgraduate Institute of Medical Sciences ### Study Description Enhanced recovery after surgery protocols are evidence-based multidisciplinary programs implemented in the perioperative setting to improve postoperative recovery and attenuate the surgical stress response. They have been used with success after many different types of surgery to improve perioperative patient outcomes. However, evidence on their effectiveness in thyroid and parathyroid surgery remains sparse. Goal of PaThERAS study is to investigate the clinical benefits and cost-effectiveness of enhanced recovery protocols for the perioperative management in patients undergoing total thyroidectomy for large goiters/ cancers and parathyroidectomy for symptomatic hyperparathyroidism in non-day-care setting. ### Conditions - Thyroid Diseases - Parathyroid Diseases - ERAS ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Enhanced recovery protocols - Conventional Protocols ### Outcomes Primary Outcomes - To compare the rate of hypocalcemia in patients undergoing thyroid and parathyroid surgery implementing Enhanced recovery after surgery protocols vs Conventional peri operative protocols Secondary Outcomes - To compare length of hospital stay in patients undergoing thyroid and parathyroid surgery in days - To compare hospital costs in patients undergoing thyroid and parathyroid surgery implementing Enhanced recovery after surgery protocols vs Conventional peri operative protocols - To compare postoperative complication rates in patients undergoing thyroid and parathyroid surgery implementing Enhanced recovery after surgery protocols vs Conventional peri operative protocols - To compare readmission rate ### Location - Facility: Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, 226014, India @@
## The Effect of Airway and Chest Wall Oscillation on Respiratory Functions in COPD Patients in Acute Exacerbation - NCT ID: NCT06274957 - Study ID: SaglikBilimleriUN - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-06-01 - Lead Sponsor: Saglik Bilimleri Universitesi ### Study Description Chronic obstructive pulmonary disease (COPD); It is a common, treatable and preventable disease characterized by progressive and irreversible airflow limitation and has systemic effects with respiratory system involvement. Increased respiratory workload, decreased work . ### Conditions - COPD Exacerbation Acute ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CONTROL - PEP DEVICE - HFCWO DEVICE ### Outcomes Primary Outcomes - COPD assessment test - Clinical COPD Questionnaire - mMRC dyspnea scale - Richard-Campbell Sleep Questionnaire - 30 second sit and stand - BODE index - chest circumference measurements - Modified Borg Scale - muscle strenght test Secondary Outcomes ### Location - Facility: University of Health Sciences, Istanbul, N/A, 34353, Turkey @@
## Nasogastric/Orogastric Tube Placement Confirmation in Neonates Utilizing Self-contained pH Device, a Feasibility Study - NCT ID: NCT06274944 - Study ID: PEDS-2023-31694 - Status: RECRUITING - Start Date: 2024-02-12 - Completion Date: 2025-01-31 - Lead Sponsor: University of Minnesota ### Study Description This study is looking at using a self-contained pH device that will assist in confirming placement of a nasogastric or orogastric tube placed in the stomach of hospitalized infants. ### Conditions - Premature Birth ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - nasogastric tube placement pH confirmation device ### Outcomes Primary Outcomes - PH reading comparison Secondary Outcomes ### Location - Facility: University of Minnesota, Minneapolis, Minnesota, 55414, United States @@
## Analysis of the Pulmonary Microbiome - NCT ID: NCT06274931 - Study ID: 373 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-06-20 - Lead Sponsor: University Magna Graecia ### Study Description The purpose of the protocol is to study the pulmonary microbiome in patients who develop pneumonia. ### Conditions - Pneumonia - Microbial Colonization - Microbial Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Bronchoscopy ### Outcomes Primary Outcomes - Assessment of Lung Microbiome in Acute Respiratory Failure Secondary Outcomes ### Location - Facility: University Hosp[ital, Catanzaro, N/A, 88100, Italy @@
## Reducing ESKAPE Transmission in the Operating Room - NCT ID: NCT06274918 - Study ID: 202111418 - Status: RECRUITING - Start Date: 2023-02-01 - Completion Date: 2024-12-01 - Lead Sponsor: University of Iowa ### Study Description This study is designed to examine the impact of a personalized, body worn alcohol dispenser on the epidemiology of ESKAPE transmission in the anesthesia work area for patients undergoing surgery requiring general anesthesia. ### Conditions - Surgical Procedure, Unspecified ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Personalized Body-Worn Alcohol Dispenser ### Outcomes Primary Outcomes - ESKAPE transmission events with and without the body worn device Secondary Outcomes - The epidemiology of ESKAPE transmission events - The epidemiology of ESKAPE transmission events - The epidemiology of ESKAPE transmission events - The epidemiology of ESKAPE transmission events - The epidemiology of ESKAPE transmission events - 90-Day Healthcare-Associated Infections ### Location - Facility: University of Iowa, Iowa City, Iowa, 52242, United States @@
## Topical Anaesthesia in Cutaneous Head and Neck Surgery - NCT ID: NCT06274905 - Study ID: 160123 - Status: COMPLETED - Start Date: 2023-02-20 - Completion Date: 2023-07-07 - Lead Sponsor: University Hospital Waterford ### Study Description This study aims to assess if EMLA or ethyl chloride spray are effective in reducing the pain associated with local anaesthetic administration in cutaneous surgery of the head and neck compared to a placebo and control group through a randomized control trial study design. ### Conditions - Pain, Acute - Head and Neck Cancer - Cutaneous Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - EMLA - Ethyl chloride - Aqueous cream BP ### Outcomes Primary Outcomes - Pain score Secondary Outcomes - Patient satisfaction ### Location - Facility: University Hospital Waterford, Waterford, N/A, X91 ER8E, Ireland @@
## Remote Monitoring of Patient Reported Outcomes to Improve the Efficacy of the Acute Phase Radiotherapy Review Process - NCT ID: NCT06274892 - Study ID: 23-5818 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-11-30 - Lead Sponsor: University Health Network, Toronto ### Study Description Radiation therapy (RT) is a key component in the treatment of breast and prostate cancer. However, patients may experience significant side effects. Patients can accurately self-report side effects from RT and these patient-reported outcomes (PROs) can direct communication between patient and healthcare provider (HCP), and facilitate joint decision making.Patients state that using mobile phone applications (apps) to collect PROs (mPROs) is easily incorporated into their daily routines, allowing them to engage at a time and pace that suits them. When mPRO collection is combined with remote symptom monitoring by HCPs, these systems result in improvements in symptom control and quality of life.Currently, patients receiving RT are seen by a Radiation Oncologist once per week during RT and once every few months after RT has finished. Recent evaluations indicate that patients and physicians consider the number of visits to be too frequent during RT, and too infrequent immediately after RT. This research will use weekly mPROs (remotely monitored by RT HCP) to determine if a patient needs (or wants) to be seen by a RT HCP during and/or immediately after RT.Using mPROs to optimize RT patient assessment processes will ensure patients are seen if and when required. For a patient, this could result in reduced time and costs at the hospital. For the physician, resources could be re-allocated to improve access to RT services. Using mPROs after RT has the potential for earlier treatment of side effects, which has been linked to improved survival and quality of life. ### Conditions - Prostate Cancer - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Remote monitoring PROs ### Outcomes Primary Outcomes - Remote monitoring efficiency Secondary Outcomes - Remote monitoring efficacy - Remote monitoring value - Remote monitoring comprehensiveness - Influencing factors (patient) - Influencing factors (disease) - Influencing factors (treatment) - Influencing factors (toxicity) ### Location - Facility: Princess Margaret Cancer Centre, Toronto, Ontario, M5G 2J9, Canada @@
## Safety of Biliary Intraductal Radiofrequency Ablation in Patients With Unresectable Extrahepatic Biliary Tract Cancer - NCT ID: NCT06274879 - Study ID: 1938 Ablatio-bilica - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-04-30 - Lead Sponsor: Insel Gruppe AG, University Hospital Bern ### Study Description The goal of this clinical trial is to provide evidence for the general tolerability of radiofrequency ablation (bRFA) in patients with unresectable bile duct cancer undergoing systemic palliative treatment consisting of chemotherapy (gemcitabine and cisplatin) plus durvalumab (immune-checkpoint-inhibitor, ICI). The main question it aims to answer is whether it is safe to combine chemotherapy (gemcitabine and cisplatin) and immunotherapy (durvalumab) - CICI therapy.Participants will be assigned to either the control group or the experimental group. In the control group, the standard of care consists of endoscopy with stent placement in the bile duct and CICI, whereas in the experimental group, bRFA will be performed in addition to the standard of care. Participants will be followed up for 6 months, during the follow-up, the stage of the tumor, blood examination, the duration of the stent from the insertion until its failure, adverse events and quality of life will be examined.Researchers will compare the standard of care alone to the experimental group to see if the additional bRFA procedure causes higher or no difference in adverse events rate. ### Conditions - Bile Duct Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Gemcitabin, Cisplatin and Durvalumab - Biliary Radiofrequency Ablation - Endoscopic Retrograde Cholangio-Pancreatography with stenting ### Outcomes Primary Outcomes - Any grade 3 or 4 adverse events (AE) leading to chemo-immune checkpoint inhibitor-therapy (CICI) discontinuation up to six months after enrolment. Secondary Outcomes - Endoscopic complications as measured by the Adverse events GastRointestEstinal Endoscopy (AGREE) criteria specifically developed for endoscopic interventions - Progression-free survival, which is defined as the time till the progression of disease or death, whatever comes first, from the time of enrolment to the end of follow-up. - Death from any cause from the time of enrolment to the end of follow-up (overall survival). - Development of disease-specific quality-of-life as measured by the EORTC QLQ-BIL21 before every CICI cycle plus at 3 and 6 months from the start of the CICI treatment - Change in health-related quality-of-life at baseline, 3 and 6 months from the start of the CICI treatment as measured by the EORTC QLQ-C30 - Stent patency at month 3 visit and end of study visit - Number of courses of CICI applied - Total dose of CICI applied ### Location - Facility: Inselspital Bern University Hospital, Bern, Be, 3010, Switzerland @@
## Effects Of A Home Based Exercise Program Following Total Hip Arthroplasty - NCT ID: NCT06274866 - Study ID: dsahinoglu - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-01-10 - Completion Date: 2024-06-30 - Lead Sponsor: Halic University ### Study Description The aim of this study is to examine the effects of home-based exercise on pain-related factors, postural control and early functional parameters in individuals undergoing total hip arthroplasty. Forty-four individuals with hip osteoarthritis were included in current study. Individuals were randomized as study group (n=23) and control group (n=21) by drawing lots. Individuals in the study group were followed up with a personalized home-based exercise program for 6 weeks. Individuals in the control group were followed up with an exercise training brochure. The exercise program of the individuals in the study group was checked at two-week intervals and adjustments were made in the exercise program. All individuals were evaluated before the operation, 2 weeks after the operation, and 12 weeks after the operation, and their data were recorded. Range of motion was measured with an inclinometer, muscle strength was measured with a hand dynamometer, joint position sense was measured with a target angle test, pain was measured with a visual pain scale, leg length was measured with a tape measure, and finally, the Q angle was measured with a goniometer. In addition to these,Tampa kinesiophobia scale, Oxford hip score and international physical activity scale were used. Timed up-and-go test was used to evaluate functional performance. Foursquare step test was used to evaluate balance, and finally, tetrax posturography device was used to evaluate postural control. ### Conditions - PHYSİOTHERAPY ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - exercise program - control group ### Outcomes Primary Outcomes - OXFORD HİP SCORE - TAMPA SCALE FOR KINESİOPHOBİA - İNTERNATİONAL PHYSİCAL ACTİVİTY QUESTİONAİRE (SHORT FORM) - JOİNT POSİTİON SENSE ERROR TEST - FOUR SQUARE STEP TEST - THE TİMED UP and GO TEST - Assessment of Hip Muscle Strength - Assessment of Hip Joint Range of Motion - Assessment of Postural Control Secondary Outcomes - MEASURİNG LEG LENGTH DİSCREPANCY - Q ANGLE ### Location - Facility: Yeditepe Hospital, Istanbul, N/A, N/A, Turkey @@
## GS-441524 for COVID-19 SAD, FE, and MAD Study in Healthy Subjects - NCT ID: NCT06274853 - Study ID: 170327-0001 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-12 - Lead Sponsor: National Center for Advancing Translational Sciences (NCATS) ### Study Description The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetics of GS-441524 in healthy subjects. The main questions to answer are: 1) What dosage of GS-441524 is required for adequate therapeutic plasma levels? 2) Does fed or fasted state produce variability in plasma levels? 3) How is GS-441524 eliminated from the body.Participants will receive varying levels of GS-441524 or placebo to evaluate AEs and plasma levels. ### Conditions - COVID-19 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - GS-441524 - Placebo ### Outcomes Primary Outcomes - Treatment-emergent adverse events (TEAEs) - Blood Pressure in mm/Hg - Pulse in beats/min - Respiratory Rate in breaths per minute - Body Temperature in degrees - Electrocardiogram (ECG) as measured by PR interval - Electrocardiogram (ECG) as measured by QT interval - Electrocardiogram (ECG) as measured by QT corrected (Fridericia's) Secondary Outcomes - Plasma PK Parameter C-Max - Plasma PK Parameter t-max - Plasma PK Parameter t-lag - Plasma PK Parameter AUC 0-last - Plasma PK Parameter AUC 0-inf - Plasma PK Parameter t 1/2 - Plasma PK Parameter CL/F - Plasma PK Parameter Vz/F - Urine PK Parameter Ae urine - Urine PK Parameter Fe urine - Urine PK Parameter CL R - Plasma PK Parameter C trough - Plasma PK Parameter AUC 0-tau - Plasma PK Parameter CL/F ss - Plasma PK Parameter Vz/F ss - Plasma PK Parameter R ac ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## COVID-19 Antibody Responses In Cystic Fibrosis - NCT ID: NCT06274840 - Study ID: CAR-CF - Status: RECRUITING - Start Date: 2022-08-08 - Completion Date: 2024-05 - Lead Sponsor: Pilar Azevedo ### Study Description Coronavirus disease 2019 (COVID-19) which is caused by the virus SARS-CoV-2 has resulted in an ongoing global pandemic. It is unclear whether the relatively low number of reported cases of COVID-19 in people with CF (pwCF) is due to enhanced infection prevention practices or whether pwCF have protective genetic/immune factors. This study aims to prospectively assess the proportion of pwCF, including both adults and children with CF who have evidence of SARS-CoV-2 antibodies over a two-year period. This study will also examine whether pwCF who have antibodies for SARS-CoV-2 have a different clinical presentation and what impact this has on their CF disease. The proposed study will recruit pwCF from paediatric and adult CF centres in Europe. Serological testing to detect antibodies will be performed on blood samples taken at month 0, 6, 12, 18 and 24 with additional time-points if bloodwork is available via normal clinical care. Clinical data on, lung function, CF-related medical history, pulmonary exacerbations, antibiotic use, and microbiology and vaccination receipt, will be collected during routine clinical assessments.Associations will be examined between socio-demographic and clinical variables and serologic testing. The effects of SARS-CoV-2 infection on clinical outcomes and analyse end-points will be examined to explore any age-related or gender-based differences, as well as subgroup analysis of outcomes in lung-transplant recipients and pwCF receiving CFTR modulator therapies. As pwCF receive COVID-19 vaccination a comparison of the development and progression of anti-SARS-CoV-2 antibodies in pwCF following natural infection and vaccination SARS-CoV-2 over time will be performed. ### Conditions - COVID-19 - Cystic Fibrosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - SARS-COV-2 seroprevalence - Association of SARS-CoV-2 seropositivity, clinical symptoms and clinical outcomes in pwCF - Longitudinal comparison of the detection Secondary Outcomes - Serum proteomic and genomic responses of pwCF ### Location - Facility: CHLN, Lisboa, N/A, 1800-268, Portugal @@
## Electromyographic Analysis of Scapular Muscles During Closed Kinetic Chain Exercises - NCT ID: NCT06274827 - Study ID: GO 22- 881 - Status: COMPLETED - Start Date: 2022-09-25 - Completion Date: 2023-06-20 - Lead Sponsor: Hacettepe University ### Study Description In shoulder rehabilitation, the inclusion of kinetic chain exercises is advocated in order to provide the necessary energy transfer to produce optimal force with minimal energy consumption. Closed kinetic chain (CKC) exercises are defined as exercises in which the distal segment is stabilized by encountering significant resistance while the proximal segment moves. In contrast, open kinetic chain (OKC) exercises allow the distal segment to move freely without any resistance. Recently, the importance of closed kinetic chain (CKC) exercises has increased in enhancing shoulder joint neuromuscular control by improving dynamic shoulder stability and joint position sense.The most current shoulder rehabilitation protocols include exercises for restoration of scapular muscle imbalances.There exist studies investigating the levels of scapular muscle activation during CKC exercises. Researchers have shown that most CKC exercises especially push-ups and plank variations with the shoulder in the 90° position, generally provide high SA activity and an optimal UT/SA ratio.In the literature, there is limited information on how the level of shoulder elevation affects scapular muscle activity and ratio during closed kinetic chain exercises in the prone position. To effectively prescribe CKC exercises commonly used in rehabilitation and athletic programs, a clear understanding of shoulder elevation changes muscle activity during these exercises is required.Our hypothesis is that glenohumeral joint elevation status will alter scapular muscle activation and activation rates. ### Conditions - Shoulder Pain - Shoulder Injuries - Activation, Patient ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Superficial Electromyography ### Outcomes Primary Outcomes - Muscle activation recorded with surface electromyography (sEMG) during CKC Secondary Outcomes ### Location - Facility: Hacettepe University, Ankara, N/A, 06430, Turkey @@
## U/S Guided Rhomboid Intercostal Block Combined With Sub-Serratus Plane Block vs Type 2 Pectoral Nerve Block - NCT ID: NCT06274814 - Study ID: AP23.501.038 - Status: RECRUITING - Start Date: 2023-06-01 - Completion Date: 2024-05-01 - Lead Sponsor: National Cancer Institute, Egypt ### Study Description The aim of this study is to compare between U/S Guided Rhomboid Intercostal Block Combined with Sub-Serratus Plane Block vs type 2 Pectoral Nerve Block in Analgesia for Breast Cancer Surgery by measuring intraoperative hemodynamics, postoperative pain scores and morphine consumption in the first 24 h postoperative. ### Conditions - Breast Neoplasm Female - Analgesics ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - U/S guided Rhomboid intercostal block (RIB) - U/S guided RIB combined with the sub-serratus plane block (RISS) ### Outcomes Primary Outcomes - Total morphine consumption - Visual Analog scale score postoperative Secondary Outcomes - Intraoperative fentanyl consumption - Heart rate intraoperative - Timing of first rescue analgesia ### Location - Facility: National cancer Insititute, Cairo, N/A, 11796, Egypt @@
## Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT) - NCT ID: NCT06274801 - Study ID: GB002-3102 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-12 - Lead Sponsor: GB002, Inc. ### Study Description This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study ### Conditions - Pulmonary Arterial Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Seralutinib - Gereic Dry Powder Inhaler ### Outcomes Primary Outcomes - Incidence of treatment-emergent adverse events (TEAEs) Secondary Outcomes - Changes in distance achieved on the Six-Minute Walk Test (6MWT) - Changes in NT-proBNP ### Location - Facility: University of Kansas Medical Center, Kansas City, Kansas, 66160, United States @@
## Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment - NCT ID: NCT06274788 - Study ID: OMEG-054-CP4 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-03-01 - Lead Sponsor: Fresenius Kabi ### Study Description This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population ### Conditions - Parenteral Nutrition Associated Liver Disease (PNALD) - Essential Fatty Acid Deficiency - Malnutrition - Pediatric ALL ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Omegaven® (fish oil triglycerides) Injectable Emulsion ### Outcomes Primary Outcomes - Incidence of essential fatty acid deficiency (EFAD) Secondary Outcomes - Incidence of clinical EFAD - Time from treatment start to EFAD diagnosis - Incidence of adverse events (AEs)/serious adverse events (SAEs) - Routine laboratory tests: Direct or conjugated bilirubin - Routine laboratory tests: triglycerides - Fatty acid profiles: α-linolenic acid - Fatty acid profiles: linoleic acid - Fatty acid profiles: arachidonic acid - Fatty acid profiles: mead acid - Fatty acid profiles: oleic acid - Fatty acid profiles: docosahexaenoic acid (DHA) - Fatty acid profiles: eicosapentaenoic acid (EPA) - Anthropometric measures: body weight - Anthropometric measures: body height/length - Anthropometric measures: head circumference ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of an Educational Nail Biopsy Video on Pre-operative Anxiety, Health Literacy, and Patient Satisfaction - NCT ID: NCT06274775 - Study ID: 23-12026811 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-07 - Lead Sponsor: Weill Medical College of Cornell University ### Study Description The investigators are interested in studying the effect of an animated video depicting a nail biopsy procedure on the anxiety, health literacy, and satisfaction of participants recommended to undergo a nail biopsy procedure. The investigators hypothesize that the animated video will reduce preoperative anxiety, increase health literacy, and increase patient satisfaction in relation to nail biopsy procedures. ### Conditions - Anxiety - Literacy - Satisfaction, Patient ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Educational Video ### Outcomes Primary Outcomes - Anxiety, as measured by the State Trait Anxiety Inventory - Anxiety, as measured by the Amsterdam Preoperative Anxiety and Information Scale - Need for information, as measured by the Amsterdam Preoperative Anxiety and Information Scale - Health literacy, as measured by 4 domains of The Health Literacy Questionnaire - Patient satisfaction, as measured by a patient satisfaction survey Secondary Outcomes - Quality of video intervention for intervention participants, as measured by a qualitative feedback survey ### Location - Facility: Weill Cornell Medicine, New York, New York, 10065, United States @@
## Visually Impaired Women Model-based Cancer Education and Breast Self-examination - NCT ID: NCT06274762 - Study ID: MARU-SBF-ROKÇ-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-03-31 - Lead Sponsor: Marmara University ### Study Description The aim of our study was to raise awareness among visually impaired women, who are in the vulnerable group, about breast cancer, which ranks first among female cancers, and to teach breast self-examination. ### Conditions - Breast Cancer Awareness and BSE in Visually Impaired Women ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Training and BSE application on a model ### Outcomes Primary Outcomes - Champion health belief model scale Secondary Outcomes ### Location - Facility: Marmara University, Istanbul, N/A, N/A, Turkey @@
## Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial - NCT ID: NCT06274749 - Study ID: 10001930 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-03-31 - Lead Sponsor: National Institute on Aging (NIA) ### Study Description Background:As people age, the cells in the pancreas that produce insulin begin to release less of this hormone, and levels of blood glucose (sugar) rise. This can lead to illnesses such as diabetes. Urolithin A (UA) is a natural nutritional supplement that may improve how the body controls blood glucose.Objective:To learn if UA improves levels of insulin and other hormones that help control blood glucose.Eligibility:People aged 55 years and older with a body mass index of 27 or higher.Design:Participants will have 6 clinic visits over 8 weeks.Participants will be screened. They will have a physical exam with blood and urine tests and a test of their heart function.UA gelcaps are taken by mouth every morning at home. Half of participants will take UA. The other half will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which they are taking.Participants will have tests during the study including:Oral glucose tolerance: Participants will drink a sweet liquid. Blood will be drawn at intervals over the next 3 hours.Continuous glucose monitor: A sensor with a needle that goes just under the skin will be placed on the upper arm. Participants will wear this sensor throughout the study.Exercise. Participants will walk on a treadmill while their heart rate, hearth rhythm, and blood pressure are monitored. They will walk in a hallway at normal and fast paces.Imaging scans of the thigh; scans of the brain are optional.... ### Conditions - Healthy Volunteer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Urolithin A - Placebo ### Outcomes Primary Outcomes - To determine if urolithin A supplementation will influence insulin secretion in response to oral glucose at 4 and 8 weeks after supplementation. Secondary Outcomes - To determine if UA supplementation will increase incretin secretion in response to oral glucose at 4 and 8 weeks after the supplementation. - To determine if UA supplementation will enhance mitochondria respiration, based on p31 spectroscopy by thigh MRI/MRS at baseline and 8 weeks after supplementation. - To determine if UA will increase brain oxidative metabolism, based on brain MRS at baseline and 8 weeks after supplementation. - To determine if UA supplementation will alter gut microbiome composition. ### Location - Facility: National Institute of Aging, Clinical Research Unit, Baltimore, Maryland, 21224, United States @@
## Safety and Performance of Motiva® Sizers - NCT ID: NCT06274736 - Study ID: CLINP-001012 - Status: RECRUITING - Start Date: 2023-04-10 - Completion Date: 2027-07-10 - Lead Sponsor: Establishment Labs ### Study Description The Motiva® Sizer clinical study is a four-year, multicenter, post-marketing, and cohort study, designed to confirm the safety and performance of Motiva® Sizer in breast augmentation or reconstruction procedures.The research will include 330 women, divided into two groups of 165 participants each (150 breast augmentation participants and 15 reconstruction participants). The Motiva® Sizer exposed group will consist of women who will undergo breast augmentation or reconstruction surgery with the use of Motiva® Sizer during the procedure, and a non-exposed group will consist of women who will undergo breast augmentation or reconstruction surgery without the use of Motiva® Sizer. This study will be conducted in Costa Rica.The main goal is to evaluate the safety and the performance of the Motiva® Sizer. To this end, the results of both groups will be compared in terms of surgical complications, surgeon's, and participant's satisfaction level as well as reoperation rates.After the augmentation or reconstruction surgery, participants will be scheduled for the following follow-up visits, (1) between 3 and 7 postoperative days, (2) between 3 and 6 postoperative weeks, (3) at 3 and (4) 6 postoperative months, and (5, 6 and 7) annually thereafter for a period of three consecutive years. In case any participant has an adverse event due to the procedure, and if required by the physician, an additional visit will be made to assess her, and this information as well as that of the scheduled visits should be recorded in the electronic data collection notebook. ### Conditions - Breast Implant; Complications - Breast Implantation; Methods, Safety and Performance - Mammaplasty - Breast Reconstruction - Breast Augmentation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Motiva Sizer ### Outcomes Primary Outcomes - Motiva Sizers Safety (complications) - Motiva Sizers Performance (satisfaction) Secondary Outcomes - Motiva Sizers Safety (reoperations) ### Location - Facility: Establishment Labs, Coyol, Alajuela, 20102, Costa Rica @@
## Responses to E-cigarette Message Source and Presentation - NCT ID: NCT06274723 - Study ID: STUDY00001220 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-12-31 - Lead Sponsor: University of Massachusetts, Worcester ### Study Description The goal of this clinical trial is to use crowdsourcing to test the effects of a message source (expert and peer) and message presentation types (one-sided and two-sided) to identify the optimal message type for young adults who vape and do not vape. ### Conditions - Vaping ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Expert - Peer - 1 Sided - 2 Sided ### Outcomes Primary Outcomes - Message acceptance - Harm perceptions Secondary Outcomes - Psychological reactance - Message liking - Source trust - Attitudes - Behavioral intentions to vape or try vaping ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## ODYSSEE Kidney Health Trial - NCT ID: NCT06274710 - Study ID: 23-5554 - Status: RECRUITING - Start Date: 2023-12-13 - Completion Date: 2026-04-13 - Lead Sponsor: University Health Network, Toronto ### Study Description INTRODUCTIONSevere CKD is defined as a risk of greater than 10% for progressing to RRT \[home hemodialysis (HHD), home peritoneal dialysis (HPD), and transplantation\] within 2 years. There is a need to improve access to CKD self-care counselling and RRT education for patients with severe CKD. Trials of CKD self-care education have achieved therapeutic benefits with moderate to high patient-provider contact. There is high potential for a trial of digital counselling for CKD self-care and RRT education to enhance patient health and quality of life.HYPOTHESESThe primary hypothesis is that ODYSSEE-KH versus usual care (UC) will significantly increase the incidence of home RRT, measured by a composite index of HHD, HPD, and preemptive kidney transplant at trial completion (median = 19 months; range: 12 to 27 months).The secondary hypothesis is that ODYSSEE-KH for CKD self-care and RRT education improves Home RRT, RRT preparation, annual hospitalization rate, engagement with CKD self-care resources at months 6 and 12 and trial completion and scores on outcome measures.RECRUITMENTPatients diagnosed with CKD who are 18 years of age or older were recruited from University Health Network (UHN), Sunnybrook Hospital, Scarborough Health Network, and The Ottawa Hospital.DESIGNODYSSEE-KH is a double-arm, parallel-group, randomized controlled trial that has assessments at baseline, months 6 and 12, and trial completion (median = 19 months; range: 12 to 27 months). This is a single-blind design with research personnel masked.ODYSSEE-KH combines automated digital counselling of CKD self-care with renal replacement therapy (RRT) education. UC enhances the standard of usual care by providing patients with conventional digital CKD education. Over 27 months, patients will be emailed on a weekly basis with a digital link to log on to their respective program using a password-protected, personal account.ANALYSISSeparate GLMs will evaluate if Digital Counselling versus UC is independently associated with outcomes at months 6 and 12 and trial completion (median = 19; range: 12 to 27 months). Dependent variables include the KDQOL-SF, SF-36, EUROIA, PHQ-9, GAD-7, MIDLS, ESSI, PWB, BMPN, AI, as well as a modified SEMCD-6. Multivariable models will adjust for baseline assessments of each outcome and potential baseline covariates (noted above). In all GLMs, significant interactions will be followed by subgroup analyses with Bonferroni post hoc tests. ### Conditions - Chronic Kidney Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - ODYSSEE-KH ### Outcomes Primary Outcomes - Incidence of home RRT Secondary Outcomes - Improvement of Home RRT - Improvement of RRT preparation with planned dialysis access - Incidence of annual hospitalization rate - Engagement with RRT education and CKD self-care counselling resources - Self-reported engagement in activities for living well - Self-reported assessment for health-related quality of life due to kidney disease - Self-reported assessment of people's aspirations and goals - Self-reported measure of overall health (e.g. pain, mental health, physical, role and social functioning) - Self-reported depression - Self-reported perceived social support - Self-reported psychological wellbeing - Self-reported anxiety - Self-reported feeling of value to self and others - Self-reported measure of psychological wellbeing and happiness - Self-reported measure of overall life experience - Self-reported measure of well-being - Self-reported readiness for change (motivation) - Self-reported confidence in doing life activities ### Location - Facility: University Health Network, Toronto, Ontario, M2N 7A2, Canada @@
## Validation of a Magnetic Sensor in Arterial Flow Recording, Compared With the Reference Method, at Various Peripheral Arterial Sites - NCT ID: NCT06274697 - Study ID: RECHMPL22_0391 - Status: RECRUITING - Start Date: 2024-04-02 - Completion Date: 2025-04 - Lead Sponsor: University Hospital, Montpellier ### Study Description The measurement of magnetic fields emitted by cardiac activity has already been studied in magneto-cardiography. To date, however, this technology has never been evaluated in the peripheral circulation.The magnetic susceptibility of iron in the circulating blood and the ionic currents in the blood stream generate a very weak induced magnetic current, which can be detected by the micro-sensor of the prototype investigators wish to study.Proving the validity of this prototype would make it a new diagnostic and even prognostic tool, non-invasive, less costly and more accessible than Doppler for screening peripheral arterial disease. ### Conditions - Lower Extremity Artery Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Evaluation by magnetic sensor ### Outcomes Primary Outcomes - Correlation of the two curve amplitudes (y) versus time (x) between the signal recording obtained by the CapMagic prototype on the radial artery and the pulsed echo-Doppler recording on the radial artery Secondary Outcomes - Correlations of the two curve amplitudes (y) versus time (x) between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording, measured on the plantar artery on one side and on the pulpal artery on the other - Correlation of the Pulsatility index (or Gosling Pulsatility index) between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording - Correlation of the Systolic rise time (SRT) between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording - Correlation of the Systolic peak between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording - Correlation of the Type of flow according to Saint-Bonnet classification between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording - Correlation of Presence of critical ischemia measured by the CapMagic prototype and the pulsed echo-Doppler recording ### Location - Facility: University Hospital Center, Montpellier, N/A, N/A, France @@
## Feasibility of Virtual Reality Assistance in Prostate Biopsy Under Local Anesthesia. - NCT ID: NCT06274684 - Study ID: 2023-01100 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-19 - Completion Date: 2025-07-01 - Lead Sponsor: University Hospital, Geneva ### Study Description The goal of this clinical trial is to test the impact of Virtual Reality (VR) assistance for anxiety management of patients undergoing prostate biopsies in local anaesthesia.The main question it aims to answer:- Is there a significant decrease on anxiety level thanks to VR-assistance?Participants will be equipped with VR headset providing an immersive visual experience accompanied with a hypnoses oriented audio during the entire procedure.Researchers will compare standardised anxiety scores with a control group. ### Conditions - Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Use of Virtual Reality Assistance during prostate biopsies ### Outcomes Primary Outcomes - Anxiety level Secondary Outcomes - Anxiety level of the surgeon - Biopsies complications ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Glymphatic MRI in Clinically Isolated Syndrome - NCT ID: NCT06274671 - Study ID: 23-24-09 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-05-15 - Lead Sponsor: University of Exeter ### Study Description The brain possesses a system to get rid of unwanted substances, named Glymphatic System (GS). When this system is faulty, these accumulate, there is local inflammation, and progressive death of the cells. This occurs in neurological diseases including Parkinson's, or Alzheimer's. Inflammation and progressive death of the cells are also present in another neurological disorder, named Multiple Sclerosis (MS).Doctors think that GS dysfunction plays a role in MS too. In this research therefore, the aim is to study whether it drives inflammation, and disease progression in MS patients.The researchers have developed a new way to find signs of alteration of the GS using a scan named Magnetic Resonance Imaging (MRI) and will use it in a pilot study on patients with a condition named Clinically Isolated Syndrome (CIS), which often represents the very beginning of MS. It would therefore be demonstrated that the GS is a new mechanism of disease in CIS, which may associate with the symptoms, or the alterations in the levels of some substances in the blood suggestive of brain cells damage.Should this study be successful, this would provide preliminary evidence to perform a larger research study to assess if GS dysfunction drives the progression of MS. ### Conditions - Clinically Isolated Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Magnetic Resonance Imaging ### Outcomes Primary Outcomes - To determine that patients with CIS display alterations of the glymphatic system visible in vivo by Structural MRI - To determine that patients with CIS display alterations of the glymphatic system visible in vivo by microstructural MRI - To determine that patients with CIS display alterations of the glymphatic system visible in vivo by diffusion-weighted MRI - To determine that patients with CIS display alterations of the glymphatic system visible in vivo by perfusion-MRI - To determine that patients with CIS display alterations of the glymphatic system visible in vivo by ALS-MRI Secondary Outcomes - To correlate in vivo measures of altered glymphatic system with MRI measures of structural integrity in CIS - To correlate in vivo measures of altered glymphatic system with MRI measures of disease activity in CIS - To correlate in vivo measures of altered glymphatic system with MRI measures of enlarged Wirchow-Robin spaces in CIS - To correlate in vivo measures of altered glymphatic system with MRI measures of microstructural altertions in CIS - To correlate in vivo measures of altered glymphatic system with MRI measures of brain perfusion in CIS - To correlate in vivo measures of altered glymphatic system in CIS with clinical measures of disease severity - To correlate in vivo measures of altered glymphatic system in CIS with fluid biomarkers of axonal injury in CIS - To correlate in vivo measures of altered glymphatic system in CIS with fluid biomarkers of astrocytis integrity in CIS - To correlate in vivo measures of altered glymphatic system in CIS with fluid biomarkers of glymphatic activity in CIS ### Location - Facility: University of Exeter, Exeter, N/A, N/A, United Kingdom @@
## The Effects of an Acute High-intensity Exercise on Heart and Brain Function in People With Spinal Cord Injury - NCT ID: NCT06274658 - Study ID: STUDY00006517 - Status: RECRUITING - Start Date: 2024-02-14 - Completion Date: 2025-08-31 - Lead Sponsor: State University of New York at Buffalo ### Study Description The heart and brain are regulated by the autonomic nervous system. Control of these organs can be disrupted in people with spinal cord injury (SCI). This may affect their ability to regulate blood pressure during daily activities and process the high-level information. Previous studies show that high-intensity exercise induces better outcomes on heart and information processing ability in non-injured people compared to moderate-intensity exercise. However, it is unknown the effects of high-intensity exercise on heart and brain function in people with SCI. Therefore, this study aims to examine the effects of a single bout of high-intensity interval training on heart and brain function in this people with SCI compared to age- and sex-matched non-injured controls. ### Conditions - Autonomic Nervous System Disease - Spinal Cord Injuries - Cognition ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - High-intensity interval exercise ### Outcomes Primary Outcomes - Low frequency of systolic blood pressure variability - High frequency of heart rate variability - Blood pressure - Heart rate Secondary Outcomes - Cerebral blood flow velocity - Symbol Digit Matched Test score - California Verbal Learning Test score - Color-Word Stroop Test score - Controlled Word Association Task score ### Location - Facility: University at Buffalo, South Campus, Buffalo, New York, 14214, United States @@
## IVUS CHIP China Registry - NCT ID: NCT06274645 - Study ID: IVUS CHIP China Registry - Status: RECRUITING - Start Date: 2024-03-12 - Completion Date: 2028-02 - Lead Sponsor: Shanghai Zhongshan Hospital ### Study Description The goal of this observational study is to learn about in patients with complex coronary lesions undergoing PCI. The main question\[s\] it aims to answer are: the clinical efficacy and safety of an IVUS-guided approach in patients with complex coronary lesions undergoing PCI, as well as clinical outcomes up to 2 years. Participants will be treated with IVUS-guided PCI. ### Conditions - Complex Higher Risk Indicated Patients Undergoing PCI ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - The OptiCross High Definition (60 MHz) and OptiCross (40MHz) Intravascular Ultrasound (IVUS) catheter from Boston Scientific ### Outcomes Primary Outcomes - Time-to-first-event analysis of these three event including cardiac death, target vessel myocardial infarction will be primarily used for clinical endpoints. Secondary Outcomes - Time-to-first-event analysis will be primarily used for clinical endpoints. ### Location - Facility: Fudan Zhongshan Hospital, Shanghai, N/A, N/A, China @@
## ADELANTE: A Randomized Controlled Trial to Improve Engagement in Care for Latinos With HIV - NCT ID: NCT06274632 - Study ID: 2023P001913 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-02-28 - Lead Sponsor: Massachusetts General Hospital ### Study Description The goal of this study is to test the effectiveness of ADELANTE on viral suppression among Latinos with HIV and viral non-suppression. Participants will receive ADELANTE (5-session, community health worker-delivered, problem-solving intervention) or enhanced care condition (ECC, 5 reminder phone calls). We will evaluate the overall effectiveness of ADELANTE compared with ECC on rates of viral suppression and emergency room visits and hospitalizations. Our hypothesis is that ADELANTE participants will achieve higher rates of viral suppression and will have lower rates of emergency room visits and hospitalizations compared with ECC at 12 months post-randomization. ### Conditions - HIV/AIDS ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - ADELANTE ### Outcomes Primary Outcomes - 12-month viral suppression Secondary Outcomes - Number of Emergency department visits - Number of Hospitalizations - 6-month viral suppression - Retention in care ### Location - Facility: University of Miami, Miami, Florida, 33146, United States @@
## Novel Mucosal Correlates Of RSV Protection In Older Adults - NCT ID: NCT06274619 - Study ID: 23HH8541 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-02 - Lead Sponsor: Imperial College London ### Study Description Respiratory syncytial virus (RSV) is one of the most common causes of chest infection worldwide. Despite this, it remains an underappreciated health problem, with the first effective RSV vaccines only approved by the FDA in May 2023 and unlikely to be widely available for some time. Although RSV infection is most frequent in young children, most deaths occur in older adults, particularly in those with underlying heart and lung disease. This is believed to be due in part to the ageing immune system's reduced ability to protect against infection and symptomatic disease.However, little is known about the way human immune responses to RSV infection in older individuals differ from those of younger people. Further understanding of the mechanisms underlying immunity and potential impairments in these higher-risk people are therefore necessary. This project aims to study the factors that influence whether or not older people develop symptomatic RSV disease in healthy older volunteers after being given an RSV-induced common cold. Samples will be taken from the blood and nose in order to identify changes in the immune system associated with susceptibility or protection in older adults. Participants will be carefully screened to ensure there are no underlying health problems that might make them more at risk of severe disease and will be monitored closely throughout the course of infection. It is anticipated that differences in immune markers in the nose and/or blood of healthy older people will predict whether or not such individuals become infected or develop symptoms. By analysing the networks of genes that are switched on and off, the aim is to identify the pathways in the immune system responsible for these differences, to ultimately develop improved diagnostic tests, vaccines and treatments. ### Conditions - Respiratory Tract Infections ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - RSV A Memphis 37 ### Outcomes Primary Outcomes - Number of solicited and unsolicited adverse events (AEs) - Infection rate Secondary Outcomes - Nasal Viral Load - Antibody levels by serum neutralisation assay - Antibody levels by ELISA ### Location - Facility: Imperial College London, London, N/A, W12 0NN, United Kingdom @@
## Exercise Training Study Before Bariatric Surgery - NCT ID: NCT06274606 - Study ID: HSR230106 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-03-15 - Lead Sponsor: University of Virginia ### Study Description The goal of this clinical trial is to figure out if 8 weeks of walking exercise before bariatric surgery improves risk factors for diabetes and other markers of health. This is important as it may help reduce complications after surgery, improve health markers and increase physical activity levels after surgery (which is an important marker of maintaining bariatric weight loss). The main question that this study is trying to answer is whether walking improves a risk factor for type 2 diabetes called insulin sensitivity (how well your body is able to use glucose).Adults planning to have bariatric surgery will be recruited from the Charlottesville VA area. Before they have their surgery, participants will be randomly assigned (like flipping a coin) to a group that participates in 8 weeks of walking on a treadmill (2-3 times a week) or a group that does their normal care before bariatric surgery.Researchers will compare the effects of walking before bariatric surgery on:* Insulin sensitivity (diabetes risk factor)* Health of blood vessels* Rate of complications after surgery* Weight* Body Fat* Fitness level ### Conditions - Bariatric Surgery Candidate ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Exercise Group ### Outcomes Primary Outcomes - Insulin sensitivity Secondary Outcomes - Surgical outcomes - readmission within 30 days of surgery - Surgical outcomes - IV treatment as an outpatient - Surgical outcomes - emergency department visits - Surgical outcomes - time of surgery - Surgical outcomes - length of stay after surgery completion - Flow-mediated dilation (FMD) - Pulse-wave analysis (PWA) - Pulse-wave velocity (PWV) - Body fat - Lean body mass - Bone mineral density - Visceral adiposity - Weight - Blood Lipids - Plasma glucose - Plasma insulin - Hemoglobin A1c - Cardiorespiratory fitness - Quality of life (SF-36) ### Location - Facility: University of Virginia, Charlottesville, Virginia, 22902, United States @@
## Study of OCT Peripapillary Angiography in Patients With Advanced Glaucoma - NCT ID: NCT06274593 - Study ID: AP_JBD_MJ_003 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-09 - Lead Sponsor: Nantes University Hospital ### Study Description Glaucoma is a chronic disease of the optic nerve, characterized by progressive loss of nerve cells in the retina, leading to progressive loss of peripheral and central vision. There are in fact several types of glaucoma, which is the world's second leading cause of blindness after cataracts, and the leading cause of irreversible blindness.To date, to our knowledge, there is no work analyzing the progression of angiographic OCT in patients with glaucoma.The main aim of this study is to compare the 3-year progression rate of 3 examinations in advanced glaucoma patients: one functional (visual field) and two anatomical (OCTa and OCTrnfl). ### Conditions - Glaucoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - OCT ### Outcomes Primary Outcomes - Compare the progression of vascular density (VD) in advanced glaucoma patients. - Compare the progression of peripapillary retinal nerve fiber (RNFL) thickness) in advanced glaucoma patients. - Compare the progression of visual field in advanced glaucoma patients. Secondary Outcomes - CV-OCTrnfl correlation study and CV-OCTa correlation study on measurements made at inclusion and on measurements made during follow-up ### Location - Facility: Jean-Baptiste Ducloyer, Nantes, N/A, 44093, France @@
## Endovascular vs Conservative Treatment in Patients With Chronic Subdural Hematomas and Mild Symptoms - NCT ID: NCT06274580 - Study ID: 5916 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-03-01 - Lead Sponsor: Ospedale Policlinico San Martino ### Study Description Embotrial-1 is an Italian multicenter prospective randomized clinical trial with open-label treatment and blinded outcome assessment (PROBE) to assess the superiority of MMA embolization compared to conservative treatment. The intervention group is MMA embolization and comparator control group is the conservative management with best medical treatment. Patients are randomized 1:1. ### Conditions - Subdural Hematoma, Chronic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - embolization of the middle meningeal artery ### Outcomes Primary Outcomes - Rate of incomplete hematoma resolution or surgical rescue Secondary Outcomes - treatment complication - treatment successful ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Intermittent Theta Burst Stimulation (iTBS) for Emotion Regulation in Bipolar Disorder - NCT ID: NCT06274567 - Study ID: 2024P000348 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2029-03-31 - Lead Sponsor: Massachusetts General Hospital ### Study Description The objective of this study protocol is to test whether intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) can strengthen functional connectivity with a key region in emotion regulation (ER) neurocircuitry (anterior insula, AI) and improve performance on ER-related tasks in patients with bipolar disorder. Individual IPL sites for stimulation will be identified through baseline, pre-TMS functional magnetic resonance imaging (fMRI) scans. Patient-specific IPL subregions showing positive functional connectivity with the anterior insula and falling within the patient-specific frontoparietal control network will be used as individualized target sites for TMS stimulation. Patients will be randomized to receive 24 sessions of active versus sham iTBS to patient-specific IPL targets (6 sessions/day, 4 days, 43,200 pulses total). Post-iTBS resting-state and task-based fMRI scans will be acquired 3 days after the final day of iTBS administration (Day 4) following identical procedures as baseline. Effects of iTBS-TMS on ER will be evaluated by comparing pre-TMS versus post-TMS functional connectivity and behavior during performance on ER tasks. ### Conditions - Bipolar Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Transcranial Magnetic Stimulation (TMS) - Sham (placebo) TMS ### Outcomes Primary Outcomes - Correlated functional magnetic resonance imaging (fMRI) time series (functional connectivity) Secondary Outcomes - Affective Multisource Interference Task - Balloon Analogue Risk Task ### Location - Facility: Martinos Center for Biomedical Imaging, Charlestown, Massachusetts, 02129, United States @@
## Testing the Role for Anti-fungal Therapy in Improving the Response to Medicine for Crohn's Disease - NCT ID: NCT06274554 - Study ID: 23-11026746 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2029-12 - Lead Sponsor: Weill Medical College of Cornell University ### Study Description The goal of this clinical trial is to learn about the effects of fluconazole in patients who plan to or are undergoing standard of care treatment with an IL-23 therapy for their Crohn's disease.The main question it aims to assess is will patient response to IL-23 therapies improve when simultaneously treated with fluconazole. ### Conditions - Crohn's Disease - Inflammatory Bowel Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Fluconazole - Placebo - IL-23 Therapy ### Outcomes Primary Outcomes - Proportion of subjects achieving clinical response Secondary Outcomes - Proportion of subjects achieving clinical remission - Proportion of patients achieving endoscopic response or remission ### Location - Facility: Weill Cornell Medicine, New York, New York, 10065, United States @@
## Upfront Systematic Tumour BRCA Testing in Patients With High Grade Serous or Endometrioid Ovarian, Fallopian Tube or Primary Peritoneal Cancer (HGSEC): The t-BRCA Study - NCT ID: NCT06274541 - Study ID: CTRIAL-IE 18-01 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2019-03-22 - Completion Date: 2025-11 - Lead Sponsor: Cancer Trials Ireland ### Study Description A pilot study to evaluate the feasibility of a NGS-based tumour BRCA1/2 mutation testing pathway initiated in the oncology clinic for patients with HGSEC, either at primary diagnosis or first relapse, whereby only patients with a positive germline BRCA1/2 mutation test will be referred to clinical genetics. ### Conditions - Serous Ovarian Tumor - Endometrioid Carcinoma Ovary - Fallopian Tube Cancer - Primary Peritoneal Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Somatic and Germline BRCA1/2 Testing ### Outcomes Primary Outcomes - Feasibility of an upfront BRCA1/2 mutation testing pathway in HGSEC in terms of clinicians' experience. - Feasibility of an upfront BRCA1/2 mutation testing pathway in HGSEC in terms of patients' experience. - The impact on patient management by determining changes in patient treatment (use of a PARP inhibitor or enrolment in BRCA-targeted clinical trials). - The impact on patient management by use of clinical genetics counselling sessions. - The economic impact of implementing an upfront tumour BRCA1/2 mutation testing pathway in the oncology clinic for HGSEC on the Irish healthcare system, using a health economic analysis (decision analysis model) Secondary Outcomes - The proportion of germline and somatic BRCA1 and BRCA2 mutations among patients with HGSEC in Ireland - Patient and disease characteristics (age, stage, degree of surgical cytoreduction, platinum sensitivity) associated with BRCA1/2 mutated HGSEC compared to BRCA1/2 wild type disease. - Differences in treatment patterns between BRCA1/2 mutated and BRCA1/2 wild type HGSEC by examining number of systemic therapies used. - Differences in treatment patterns between BRCA1/2 mutated and BRCA1/2 wild type HGSEC by examining use of PARP inhibitor therapy. - Differences in treatment patterns between BRCA1/2 mutated and BRCA1/2 wild type HGSEC by examining enrolment in clinical trials - Identification of clinical outcomes (response platinum free interval (PFI)) associated with BRCA1/2-mutated HGSEC, as compared to BRCA1/2 wild type disease. - Identification of clinical outcomes (progression free survival (PFS)) associated with BRCA1/2-mutated HGSEC, as compared to BRCA1/2 wild type disease. - Identification of clinical outcomes (overall survival (OS)) associated with BRCA1/2-mutated HGSEC, as compared to BRCA1/2 wild type disease. ### Location - Facility: Mater Misericordiae University Hospital / Mater Private Hospital, Dublin, Leinster, N/A, Ireland @@
## DORA and LP in Alzheimer's Disease Biomarkers - NCT ID: NCT06274528 - Study ID: 202301150 - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2029-03-11 - Lead Sponsor: Washington University School of Medicine ### Study Description The purpose of this study is to see if the sleep aid, lemborexant, can decrease the amount of amyloid-beta and tau in the fluid around the brain known as cerebrospinal fluid (CSF). Amyloid-beta and tau are proteins involved in the disease process leading to Alzheimer's disease. ### Conditions - Alzheimer Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Lemborexant 10 mg - Lemborexant 20mg - Placebo ### Outcomes Primary Outcomes - Changes CSF pT181/T181 ratio of lemborexant 10 and 20 mg compared to Placebo Secondary Outcomes - Number of participants with treatment-related adverse events - Measure the blood concentration of lemborexant 10 mg and 20 mg and determine the dose-response relationship with CSF pT181/T181 - Measure changes on blood plasma amyloid-beta isoforms (Aβ38, Aβ40, Aβ42) - Measure changes of CSF amyloid beta isoforms (Aβ38, Aβ40, Aβ42) - Measure changes of blood plasma p-tau/tau forms (T181, pT181, S202, pS202, pS202/S202, T217, pT217, pT217/T217). - Measure changes of cerebrospinal fluid p-tau/tau forms (T181, pT181, S202, pS202, pS202/S202, T217, pT217, pT217/T217). ### Location - Facility: Washington University in St. Louis, School of Medicine, Saint Louis, Missouri, 63110, United States @@
## A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies - NCT ID: NCT06274515 - Study ID: WO44977 - Status: RECRUITING - Start Date: 2024-04-02 - Completion Date: 2027-01-28 - Lead Sponsor: Hoffmann-La Roche ### Study Description This study will evaluate mechanisms of resistance to anti-breast cancer therapies in tumor and blood samples from participants with human epidermal growth factor receptor (HER2) positive, hormone receptor (HR) positive or triple negative breast cancer. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tumor Tissue and Blood Draw ### Outcomes Primary Outcomes - Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2) - Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohorts H1 and H2) - Changes from baseline in estrogen receptor (ER) protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2) - Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohort H3) - Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohort H3) - Changes from baseline in ER protein levels measured at the time of disease progression/recurrence (Cohort H3) - Changes from baseline in genes related to CDK4/6 resistance (incl. cell cycle alterations and tyrosine kinase receptors, Cohort R1) - Changes from baseline in genes related to endocrine resistance (incl. cell cycle alterations and tyrosine kinase receptors, Cohort R1) - Changes from baseline in tumor immune microenvironment (PD-L1 and TILs, Cohort T1) - Changes from baseline in immune phenotype (PD-L1 and TILs, Cohort T1) Secondary Outcomes ### Location - Facility: KEM/Evang. Kliniken Essen Mitte gGmbH; Klinik für Internistische Onkologie / Hämatologie, Essen, N/A, 45136, Germany @@
## Automated Detection and Diagnosis of Pathological DRGs in PHN Patients Using Deep Learning and Magnetic Resonance - NCT ID: NCT06274502 - Study ID: deep learning - Status: COMPLETED - Start Date: 2023-10-01 - Completion Date: 2024-01-31 - Lead Sponsor: Huazhong University of Science and Technology ### Study Description Here, this study aimed to develop an automated system for detecting and diagnosing lesion DRGs in PHN patients based on deep learning. This study retrospectively analyzed the DRG images of all patients with postherpetic neuralgia who underwent magnetic resonance neuroimaging examinations in our radiology department from January 2021 to February 2022. After image post-processing, the You Only Look Once (YOLO) version 8 was selected as the target algorithm model. Model performance was evaluated using metrics such as precision, recall, Average Precision, mean average precision and F1 score. ### Conditions - Deep Learning ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - YOLOv8 ### Outcomes Primary Outcomes - Develop an automated system for detecting and diagnosing lesion DRGs in PHN patients based on deep learning Secondary Outcomes ### Location - Facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430030, China @@
## A Study to Evaluate Setanaxib in Patients With Alport Syndrome - NCT ID: NCT06274489 - Study ID: GSN000500 - Status: RECRUITING - Start Date: 2023-11-27 - Completion Date: 2025-01-27 - Lead Sponsor: Calliditas Therapeutics AB ### Study Description The purpose of the study is to learn about the safety and tolerability of setanaxib in subjects with Alport syndrome, when added to their standard of care treatment. The study will assess how safe setanaxib is when compared to placebo. Study participants will be asked if they are experiencing any side effects at each study visit. In addition, tests in blood, urine and other examinations will be used to look at the safety of setanaxib. The study will also measure how well setanaxib works in comparison to a placebo, by measuring urine protein and certain markers in the blood and urine. The concentration of setanaxib in the blood will also be measured throughout the course of the study.Setanaxib is planned for use together with the current standard of care to hopefully provide additional therapeutic benefits by preserving kidney function.The study will be conducted at multiple research sites in the UK, Spain, and Czech Republic. Eligible participants will be randomly assigned to receive either setanaxib or placebo. Setanaxib dose level will depend on age and all participants will receive their standard of care in addition to setanaxib or placebo. The study consists of a Screening period of up to 4 weeks, a 24-week Treatment period and a 4- week Follow-up period. ### Conditions - Alport Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Setanaxib - Placebo ### Outcomes Primary Outcomes - Percentage of patients with Serious Adverse Events (SAEs) - Percentage of patients with treatment-emergent Adverse Events of Special Interest (AESIs) Secondary Outcomes - The ratio of urine protein to creatinine ratio (UPCR) analysed in 24-hour urine sample - Percentage of patients with a 25% reduction in UPCR analysed in 24-hour urine sample - Pre-dose and post-dose plasma concentrations of setanaxib and GKT138184 measured as the area under the concentration-time curve over 24 hours at steady state (AUC0-24-ss) - Pre-dose and post-dose plasma concentrations of setanaxib and GKT138184 measured as the minimum plasma concentration at steady state (Cmin-ss) - Pre-dose and post-dose plasma concentrations of setanaxib and GKT138184 measured as the maximum plasma concentration at steady state (Cmax-ss) ### Location - Facility: Fakultni Nemocnice Hradec Kralove, Hradec Králové, N/A, N/A, Czechia @@
## Prosthetic Rehabilitation of Thin Wiry Ridge by Ridge Splitting and Simultaneous Implants Placement - NCT ID: NCT06274476 - Study ID: 2020/9/9 - Status: COMPLETED - Start Date: 2018-09-09 - Completion Date: 2020-01-01 - Lead Sponsor: Cairo University ### Study Description evaluates the success of prosthetic rehabilitation of thin wiry ridge and implants placed simultaneously in splitted ridge both clinically and radiographically. ### Conditions - Atrophic Maxillary Ridge and Mandibular Ridge ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - implant placement ### Outcomes Primary Outcomes - implant success Secondary Outcomes ### Location - Facility: Mohamed yahia Sharaf, Zagazig, Sharkia, 44715, Egypt @@
## A Personalized Trunk Stability Exercise Program Study With Brain Disease Patients - NCT ID: NCT06274463 - Study ID: 2023-11-035 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-21 - Completion Date: 2024-12-31 - Lead Sponsor: Bundang CHA Hospital ### Study Description To investigate the effect on improving trunk stability and satisfaction with the program when a customized trunk stabilization exercise program personalized to the subject's functional level is applied to patients with brain disease. ### Conditions - Brain Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Exercise therapy including a trunk stabilization exercise program ### Outcomes Primary Outcomes - Trunk Impairment Scale - Berg Balance Scale Secondary Outcomes - Joint angle - Joint moment - Joint power ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Clinical Study on the Improvement of Skin and Living Conditions After Drinking Rosa Roxburghii and Pomegranate Drinks - NCT ID: NCT06274450 - Study ID: C2202112 - Status: COMPLETED - Start Date: 2022-07-06 - Completion Date: 2022-09-02 - Lead Sponsor: Botanee Group Co., Ltd. ### Study Description The main objective of the study is to observe changes in the subjects' skin condition and life status after 8 weeks of drinking rosa roxburghii and pomegranate drinks.This is a single-center, randomized, single-blind, controlled, 8-week (56-day) clinical study conducted in Chinese healthy women aged 25-45 years old who were offered a rosa roxburghii and pomegranate drink. ### Conditions - Skin Laxity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - skin care product - Drinks with active ingredients Rosa Roxburghii and Pomegranate ### Outcomes Primary Outcomes - Changes in the skin hydration - Changes in the skin glossiness - Changes in the skin firmness - Changes in the skin elasticity - Changes in the individual type angle - Changes in the melanin content - Changes in the proportion of crow's feet area - Changes in the proportion of fine lines under the eye - Changes in the CIE RGB of skin tone - Changes in the grade of Pigmentation - Skin condition Assessment after 4-week application - Skin condition Assessment after 8-week application Secondary Outcomes - Changes in the satisfaction with the quality of life ### Location - Facility: Shanghai China-norm Quality Technical Service Co ，Ltd, Shanghai, Shanghai, 200072, China @@
## A Study of BND-35 in Participants With Advanced Solid Tumors - NCT ID: NCT06274437 - Study ID: BND-35-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-11 - Lead Sponsor: Biond Biologics ### Study Description This is an open-label, multicenter, dose escalation and dose optimization study designed to evaluate safety, tolerability and preliminary anti-tumor activity of BND-35 administered alone and in combination with nivolumab or with cetuximab. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy. The study will be comprised of two parts - a dose escalation phase (Part 1) and a dose optimization (Part 2). Part 1 is comprised of three sub-parts: BND-35 administered alone (Sub-Part 1A), BND-35 administered in combination with nivolumab (Sub-Part 1B), and BND-35 administered in combination with cetuximab (Sub-Part 1C). Part 2 is composed of two sub-parts: a dose optimization part where up to two doses of BND-35 per indication are administered in combination with nivolumab or with cetuximab. ### Conditions - Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - BND-35 - Nivolumab - Cetuximab ### Outcomes Primary Outcomes - Part 1: Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) - Part 1: Proportion of patients who discontinued study treatment due to TEAEs - Part 1: Incidence of TEAEs dose limiting toxicities (DLT) - Part 2: Objective Response Rate (ORR) per RECIST v1.1 - Part 2: Incidence of TEAEs and SAEs Secondary Outcomes - Part 1: Objective Response Rate (ORR) per RECIST v1.1 - Part 1: Maximum observed plasma concentration (Cmax) - Part 1: Serum concentration at the end of the dosing interval (Ctrough) - Part 1: Time of maximum observed serum concentration (Tmax) - Part 1: Terminal elimination half-life (T1/2) - Part 1: Area under the plasma concentration-time curve (AUC) - Part 1: Incidence of anti-drug antibodies (ADA) - Part 2: Progression Free Survival (PFS) - Part 2: PFS rate - Part 2: Duration of Response - Part 2: Maximum observed plasma concentration (Cmax) - Part 2: Serum concentration at the end of the dosing interval (Ctrough) - Part 2: Time of maximum observed serum concentration (Tmax) - Part 2: Terminal elimination half-life (T1/2) - Part 2: Area under the plasma concentration-time curve (AUC) - Part 2: Incidence of anti-drug antibodies (ADA) ### Location - Facility: Rambam Health Care Campus, Haifa, N/A, 3109601, Israel @@
## Hair Cortisol and Symptoms in Children With Psychopathology During CBT - NCT ID: NCT06274424 - Study ID: HUS/211/2016 and HUS/2699/2018 - Status: COMPLETED - Start Date: 2016-07-01 - Completion Date: 2019-10-01 - Lead Sponsor: Helsinki University Central Hospital ### Study Description This study aims to examine the relationship between hair cortisol concentration and behavior and sleep disturbance symptoms in children with psychiatric disorders. It also investigates potential changes in hair cortisol and symptomatology after group-based cognitive behavior therapy. Furthermore, the study explores the effects of any alterations in hair cortisol concentration levels on potential behavior and sleep disturbance symptom change over the course of the study. ### Conditions - Child Behavior Problem ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - The Friends Program ### Outcomes Primary Outcomes - Hair Cortisol Concentration - Parent- and teacher rated internalizing and externalizing symptoms - Child-rated internalizing symptoms - Parent-rated sleep disturbance symptoms Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention - NCT ID: NCT06274411 - Study ID: KS2024014 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-03-01 - Lead Sponsor: Beijing Anzhen Hospital ### Study Description The goal of this multicenter, randomized trial is to compare standby cannulated ECMO versus prophylactic ECMO in patients undergoing high-risk percutaneous coronary intervention (PCI). The main question it aims to answer is :• If standby cannulated ECMO as compared with prophylactic ECMO will improve the outcomes in patients undergoing high-risk PCI ### Conditions - ECMO - High-risk PCI ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Standby cannulated ECMO - Prophylactic ECMO ### Outcomes Primary Outcomes - Composite rate of 8 major adverse events Secondary Outcomes - Platelet drop - Duration of ECMO support - Length of hospital stay - Hemoglobin drop - Serum interleukin-6 concentration ### Location - Facility: Beijing Anzhen Hospital, Beijing, Beijing, 100029, China @@
## Rectal Insert TAF/EVG Pre-Exposure Prophylaxis (RITE PrEP) Study - NCT ID: NCT06274398 - Study ID: RITE Study - Status: RECRUITING - Start Date: 2024-01-16 - Completion Date: 2024-12-31 - Lead Sponsor: Eastern Virginia Medical School ### Study Description This is a double-blind, placebo-controlled, randomized two-phase study to evaluate the safety and pharmacokinetics (PK) of two TAF/EVG inserts administered rectally for 3 consecutive days, then every other day for 14 days. ### Conditions - Safety Issues ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - TAF/EVG rectal insert - Matching placebo rectal insert ### Outcomes Primary Outcomes - Frequency and intensity of Adverse Events - Pharmacokinetics (PK) (maximum concentration (Cmax)) in blood - PK (Cmax) in rectal secretions - PK (Cmax) in rectal mucosal tissue Secondary Outcomes - PK (Cmax) in cervicovaginal secretions - PK (Cmax) in cerviocovaginal mucosal tissues - Cytokine Profiles - Microbiome Profiles ### Location - Facility: Emory Clinic, Atlanta, Georgia, 30322, United States @@
## The Effects of an Acute Dose of a Betalain-rich Concentrate on Repeated-sprint Cycling Performance and Recovery. - NCT ID: NCT06274385 - Study ID: 2311010178 - Status: RECRUITING - Start Date: 2024-02 - Completion Date: 2024-06 - Lead Sponsor: Drexel University ### Study Description Betalains have well-known antioxidant and anti-inflammatory properties. Recent investigations examining the effects of a betalain-rich concentrate (BRC) on exercise and recovery performance show promise of BRC as an ergogenic aid. To date, no study has examined the effects of a single dose of a BRC on supramaximal performance and recovery. Therefore, the purpose of this study is to examine the effects of an acute dose of BRC on repeated-sprint cycling performance and recovery. ### Conditions - Nutraceuticals ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Betalain-rich concentrate (AltRed) - Placebo ### Outcomes Primary Outcomes - Repeated Sprint Performance Secondary Outcomes - Neuromuscular Fatigue ### Location - Facility: Drexel University - Health Sciences Building, Philadelphia, Pennsylvania, 19102, United States @@
## The Effect of Flow-controlled Ventilation on Hemodynamic and Respiratory Parameters in Laparoscopic Surgeries - NCT ID: NCT06274372 - Study ID: FCV,V-2202 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-08-07 - Completion Date: 2024-08-06 - Lead Sponsor: Derince Training and Research Hospital ### Study Description It is aimed to investigate the effect of flow controlled ventilation on intraoperative respiratory parameters and hemodynamic parameters in laparoscopic operations. ### Conditions - Laparoscopic Surgeries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - flow controlled ventilation - volume controlled ventilation ### Outcomes Primary Outcomes - effects of flow controlled ventilation on heamodynamic parameters - effectcs of flow controlled ventiletion on respiratory parameters - effects of flow controlled ventilation on heamodynamic parameters - effects of flow controlled ventilation on heamodynamic parameters - effectcs of flow controlled ventiletion on respiratory parameters Secondary Outcomes - respiratory related complications ### Location - Facility: Kocaeli Derince Training and Research Hospital, Derince, Kocaeli, 41900, Turkey @@
## Digital Storytelling to Reduce Pediatric Influenza Vaccination Disparities - NCT ID: NCT06274359 - Study ID: 21-3985 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-08-31 - Lead Sponsor: Denver Health and Hospital Authority ### Study Description While the COVID-19 pandemic has highlighted health disparities, Black children have unduly suffered and died from seasonal influenza for decades. Through sustained partnership with Black community stakeholders, novel community-engaged research methods, and an innovative intervention approach, this proposal will explore, develop, and test a Digital Storytelling intervention to reduce influenza vaccination disparities in Black children aged 6 months to 5 years. This project will advance our understanding of engagement methods and interventions that improve health equity and serve as a model for future work to address vaccination disparities, ensuring all individuals have the chance to fulfill their potential free of preventable diseases. ### Conditions - Influenza ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Digital storytelling ### Outcomes Primary Outcomes - Child influenza vaccination status at influenza season's end (defined as March 31, 2025 for season 1 and March 31, 2026 for season 2 if a 2nd season of recruitment is necessary) Secondary Outcomes - Intervention Feasibility - Intervention Acceptability - Intervention Appropriateness ### Location - Facility: Denver Health Eastside Clinic, Denver, Colorado, 80205, United States @@
## Effect of Retro Walking Versus Isometric Multi-angular Exercises on Pain and Functional Performance in Knee Osteoarthritis in Geriatric Population - NCT ID: NCT06274346 - Study ID: ahmedU - Status: COMPLETED - Start Date: 2023-06-01 - Completion Date: 2023-11-30 - Lead Sponsor: Delta University for Science and Technology ### Study Description Osteoarthritis is a leading musculoskeletal cause of disability in elderly persons all over the world and a major cause of physical limitations and reduced quality of life (1). Its onset is around 40 years of age and it is estimated that over 80% of people over 55 have evidence of radiographic changes in the knee due to osteoarthritis. It has been estimated that the incidence has increased by the increase in life expectancy and it has been identified as a frequent cause for health services demand in patients over 65(2).The common clinical manifestations of knee OA include pain, stiffness, joint enlargement, crepitus, muscle weakness, deformity, impaired proprioception, reduced joint motion, and disability(3).Patients with knee Osteoarthritis seems to develop their own gait pattern and try to unload the affected structures during gait. More over patients with less severe knee osteoarthritis develop a gait pattern that differs from patients with severe osteoarthritis and control group of patients (4).Isometric exercises are types of strength training in which the joint angle and muscle length do not change during contraction, and therefore this approach can be advantageous in the early stages of knee rehabilitation in cases where the range of motion is restricted due to pain (13). No physical work is performed during isometric exercise. Intensity and duration combination reflects the energy consumption of an isometric contraction (14). In addition, muscle strength increases in isometric exercise are specific to the angle applied. It was also concluded that isometric exercise performed at different angles should be especially considered as an alternative strength training since it induces the most noticeable and fastest increase in muscle moment (15). A study was conducted to investigate the effects of isometric quadriceps exercise on muscle strength, pain, and function in knee osteoarthritis, it was concluded that isometric quadriceps exercise program showed beneficial effects on quadriceps muscle strength, pain, and functional disability in patients with osteoarthritis of the knee (16).Another study was conducted to assess the effectiveness of Isometric exercise and counseling on level of pain among patients with Knee osteoarthritis, the authors concluded that Isometric exercise and counseling program has significantly reduced pain, stiffness and improved physical function and the authors recommended that Isometric exercise and counselling should be adopted as a routine care in the hospitals treating patients with knee osteoarthritis (17) Thus, we hypothesized that a less intensive walking program such as retro walking program could provide an additional benefit more than those experienced by forward walking program in the previous studies. Therefore, the primary aim of the present study was to compare the effect of retro walking versus isometric multiangular exercises group on knee pain and function in geriatric people.Materials and MethodsThis randomized controlled experimental trial was carried out at the outpatient clinic of faculty of physical therapy, Delta University for science and technology from June 2023 to November 2023. The aims of the study and the study protocol were explained for each patient before participation in the study. All patients signed an approved informed consent form for participation in this study. Before starting the treatment program, a complete history and physical examination will be taken for all patients.Subjects:Sixty male and female geriatric patients had chronic knee osteoarthritis were chosen the outpatient clinic of faculty of physical therapy, Delta University for science and technology. In each case, the diagnosis of knee OA was based on the criteria specified by the American College of Rheumatology.We recorded the height, weight, and medical history, and lower extremity dominance, level of education, occupation and duration of complaints of each patient. All were evaluated at the beginning of the treatment (week 0), at the endpoint of the treatment (week 4) ### Conditions - Knee Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Multiangular Isometric exercise ### Outcomes Primary Outcomes - Pain intensity - Functional assessment: Secondary Outcomes ### Location - Facility: Delta University For Science and Technology, Gamasa, Almansourah, 38733, Egypt @@